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###15337700\
BACKGROUND	Adrenergic activation is thought to be an important determinant of outcome in subjects with chronic heart failure ( CHF ) , but baseline or serial changes in adrenergic activity have not been previously investigated in a large patient sample treated with a powerful antiadrenergic agent .\
RESULTS	Systemic venous norepinephrine was measured at baseline , 3 months , and 12 months in the beta-Blocker Evaluation of Survival Trial ( BEST ) , which compared placebo treatment with the beta-blocker/sympatholytic agent bucindolol .\
RESULTS	Baseline norepinephrine level was associated with a progressive increase in rates of death or death plus CHF hospitalization that was independent of treatment group .\
RESULTS	On multivariate analysis , baseline norepinephrine was also a highly significant ( P < 0.001 ) independent predictor of death .\
RESULTS	In contrast , the relation of the change in norepinephrine at 3 months to subsequent clinical outcomes was complex and treatment group-dependent .\
RESULTS	In the placebo-treated group but not in the bucindolol-treated group , marked norepinephrine increase at 3 months was associated with increased subsequent risks of death or death plus CHF hospitalization .\
RESULTS	In the bucindolol-treated group but not in the placebo-treated group , the 1st quartile of marked norepinephrine reduction was associated with an increased mortality risk .\
RESULTS	A likelihood-based method indicated that 18 % of the bucindolol group but only 1 % of the placebo group were at an increased risk for death related to marked reduction in norepinephrine at 3 months .\
CONCLUSIONS	In BEST , a subset of patients treated with bucindolol had an increased risk of death as the result of sympatholysis , which compromised the efficacy of this third-generation beta-blocker .\
\
###11239100\
OBJECTIVE	The study evaluated the effectiveness of a three-year outpatient commitment pilot program established in 1994 at Bellevue Hospital in New York City .\
METHODS	A total of 142 participants were randomly assigned ; 78 received court-ordered treatment , which included enhanced services , and 64 received the enhanced-service package only .\
METHODS	Between 57 and 68 percent of the subjects completed interviews at one , five , and 11 months after hospital discharge .\
METHODS	Outcome measures included rehospitalization , arrest , quality of life , symptomatology , treatment noncompliance , and perceived level of coercion .\
RESULTS	On all major outcome measures , no statistically significant differences were found between the two groups .\
RESULTS	No subject was arrested for a violent crime .\
RESULTS	Eighteen percent of the court-ordered group and 16 percent of the control group were arrested at least once .\
RESULTS	The percentage rehospitalized during follow-up was about the same for both groups-51 percent and 42 percent , respectively .\
RESULTS	The groups did not differ significantly in the total number of days hospitalized during the follow-up period .\
RESULTS	Participants ' perceptions of their quality of life and level of coercion were about the same .\
RESULTS	From the community service providers ' perspective , patients in the two groups were similarly adherent to their required treatments .\
CONCLUSIONS	All results must be qualified by the fact that no pick-up order procedures for noncompliant subjects in the court-ordered group were implemented during the study , which compromised the differences between the conditions for the two groups , and that persons with a history of violence were excluded from the program .\
\
###14744358\
OBJECTIVE	Octylcyanoacrylate ( Dermabond ) is a tissue `` glue '' useful in closing surgical skin incisions .\
OBJECTIVE	We compared skin octylcyanoacrylate with subcuticular skin sutures to close laparoscopic trocar sites .\
METHODS	A randomized double-armed study was performed with 59 patients in whom 228 trocar sites were closed .\
METHODS	Twenty-nine patients underwent subcuticular closure with 4-0 absorbable suture , and thirty patients received closure with octylcyanoacrylate in accordance with the recommendations of the manufacturer ( Ethicon ; Somerville , NJ ) .\
METHODS	The number of sutures or vials of octylcyanoacrylate used , closure times , and postoperative wound problems were recorded .\
METHODS	Wounds were assessed 2 weeks postoperatively for healing complications .\
METHODS	Closure costs were estimated using published operating room time per hour plus the cost of octylcyanoacrylate or suture .\
METHODS	Student 's paired t-test was used for statistical analysis .\
RESULTS	The overall mean time required for skin closure using octylcyanoacrylate and suture was 3.7 minutes and 14 minutes , respectively ( P < 0.00001 ) .\
RESULTS	An average of 2.2 packets of suture were used to close all port sites in a particular patient , while closure with octylcyanoacrylate required an average of 3.4 vials per patient .\
RESULTS	Wound complications consisted of subcuticular seroma with skin separation and were equally common in the two groups .\
RESULTS	The overall average cost per closure using octylcyanoacrylate was $ 198 US dollars , while the cost for closure using suture was $ 497 US dollars ( P < 0.00001 ) .\
CONCLUSIONS	Laparoscopic port-site skin closure with octylcyanoacrylate is rapid and effective .\
CONCLUSIONS	The method yields cost savings and a decrease in operative time of more than 9 minutes per case .\
\
###11023935\
BACKGROUND	Glucose and insulin levels are associated with left ventricular mass ( LVM ) in insulin-resistant individuals .\
BACKGROUND	Antihypertensive drugs have different effects on glucose and insulin metabolism ( GIM ) and on LVM .\
BACKGROUND	To evaluate whether the effects of antihypertensive therapy on LVM are associated with its effects on GIM , we compared the effects of atenolol and perindopril on these parameters in a group of insulin-resistant , obese hypertensives .\
RESULTS	A total of 21 obese , nondiabetic hypertensives who were aged 55 + / -12 years , had a body mass index of 32.8 + / -5.0 kg/m ( 2 ) , were free of coronary or valvular heart disease , and had normal LV function were randomized to treatment with atenolol ( n = 11 ) or perindopril ( n = 10 ) .\
RESULTS	Echocardiographic LVM corrected for height ( LVM/height ) and GIM ( 3-hour intravenous glucose tolerance test ) were measured after 4 to 6 weeks of washout and 6 months of treatment .\
RESULTS	Baseline characteristics were similar in both groups .\
RESULTS	Atenolol and perindopril effectively reduced blood pressure ( from 149 + / -13 / 98 + / -4 to 127 + / -8 / 82 + / -6 mm Hg and from 148 + / -9 / 98 + / -4 to 129 + / -9 / 82 + / -6 mm Hg , respectively , for the atenolol and perindopril groups ; P : = 0.002 ) .\
RESULTS	Atenolol significantly worsened GIM parameters , fasting glucose levels ( 5.3 + / -0.9 to 6.0 + / -1.5 mmol/L ; P : = 0.003 ) , fasting insulin levels ( 121 + / -121 to 189 + / -228 pmol/L ; P : = 0.03 ) , and most other relevant metabolic measures ( P : < 0.05 for all ) .\
RESULTS	Perindopril did not affect GIM .\
RESULTS	Atenolol did not affect LVM/height ( 119 + / -12 to 120 + / -17 g/m ; P : = 0.8 ) , whereas perindopril significantly reduced LVM/height ( 120 + / -13 to 111 + / -19 g/m ; P : = 0.04 ) .\
CONCLUSIONS	In obese , hypertensive individuals , adequate and similar blood pressure control was achieved with perindopril and atenolol .\
CONCLUSIONS	However , perindopril but not atenolol was associated with a more favorable GIM profile and led to a significant regression of LVM .\
\
###25409100\
OBJECTIVE	The goal of the study was to assess semantic priming to emotion and nonemotion cue words using a novel measure of associational breadth for participants who either took rapid eye movement ( REM ) or nonrapid eye movement ( NREM ) naps or who remained awake ; assess relation of priming to REM sleep consolidation and REM sleep inertia effects .\
METHODS	The associational breadth task was applied in both a priming condition , where cue-words were signaled to be memorized prior to sleep ( primed ) , and a nonpriming condition , where cue words were not memorized ( nonprimed ) .\
METHODS	Cue words were either emotional ( positive , negative ) or nonemotional .\
METHODS	Participants were randomly assigned to either an awake ( WAKE ) or a sleep condition , which was subsequently split into NREM or REM groups depending on stage at awakening .\
METHODS	Hospital-based sleep laboratory .\
METHODS	Fifty-eight healthy participants ( 22 male ) ages 18 to 35 y ( Mage = 23.3 4.08 y ) .\
RESULTS	The REM group scored higher than the NREM or WAKE groups on primed , but not nonprimed emotional cue words ; the effect was stronger for positive than for negative cue words .\
RESULTS	However , REM time and percent correlated negatively with degree of emotional priming .\
RESULTS	Priming occurred for REM awakenings but not for NREM awakenings , even when the latter sleep episodes contained some REM sleep .\
CONCLUSIONS	Associational breadth may be selectively consolidated during REM sleep for stimuli that have been tagged as important for future memory retrieval .\
CONCLUSIONS	That priming decreased with REM time and was higher only for REM sleep awakenings is consistent with two explanatory REM sleep processes : REM sleep consolidation serving emotional downregulation and REM sleep inertia .\
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###22456624\
OBJECTIVE	Quality of bowel cleansing significantly increases the shorter the time between bowel solution intake and endoscopic examination .\
OBJECTIVE	We tested the efficacy and patient tolerability following a modified polyethylene glycol electrolyte ( PEG ) splitting regimen .\
METHODS	This was a prospective , single-blind , randomized , study .\
METHODS	Patients were assigned to receive either PEG 4 L the afternoon before colonoscopy or PEG 3 L the day before and 1 L 3h before the procedure the day of colonoscopy .\
RESULTS	The study population consisted of 336 patients , including 168 participants in each study arm .\
RESULTS	Although the bowel preparation quality was similarly quoted as excellent/good following the split and full regimen ( 95.2 % vs 92.8 % ; p = 0.3 ) , a significant ( p < 0.0001 ) shift from good towards an excellent preparation ( 26.8 % vs 68.4 % ) was observed following the split regimen as compared to the full regimen ( 55.4 % vs 37.5 % ) .\
RESULTS	The incidence of side-effects did not differ .\
RESULTS	When patients were asked about a future preparation if needed , 69 % and 31 % following the split and full regimen , respectively , declared to accept again the same preparation , the difference being statistically significant ( p < 0.001 ) .\
CONCLUSIONS	Our data found that an excellent bowel cleansing could be frequently achieved by simply modifying the split regimen from the standard PEG 2 plus 2 L to 3 plus 1 L.\
\
###9813759\
OBJECTIVE	This study evaluated an eating disorder intervention multimedia program modeled after self-help eating disorder treatment programs .\
OBJECTIVE	It was hypothesized that women who completed the program would increase their body satisfaction and decrease their preoccupation with weight and frequency of disordered eating behaviors .\
METHODS	Participants were 57 undergraduate females randomly assigned to either the intervention or control group .\
METHODS	Psychological functioning was assessed at baseline , at 3 months postintervention , and at 3 months follow-up .\
RESULTS	Intervention group subjects significantly improved their scores on all psychological measures over time .\
RESULTS	When compared to the control group , however , only the intervention group 's improvements on the Body Shape Questionnaire were statistically significant .\
CONCLUSIONS	This study has demonstrated that minimally effective eating disorder intervention programs can be delivered .\
CONCLUSIONS	A revised program that eliminates interface problems and increases the structure of the intervention is likely to be even better received and more effective .\
\
###11560562\
OBJECTIVE	The objective of our study was to define the interaction between either unfractionated heparin ( UFH ) or a low molecular weight heparin , reviparin ( REV ) , and the pharmacodynamic profile of the GPIIb/IIIa-antagonists abciximab ( ABC ) or tirofiban ( T ) .\
METHODS	Two studies each containing 18 healthy subjects were performed , and all were pretreated with aspirin ( ASA ) for 3 days .\
METHODS	Volunteers then received UFH ( 5000 IU bolus/infusion 7 IU kg ( -1 ) h ( -1 ) for 7 h , n = 6 ) , REV ( 4200-anti-Xa-IU s.c. , n = 6 ) or placebo ( n = 6 ) .\
METHODS	One hour later , ABC ( study I ) or T ( study II ) were given by i.v. infusion for 6 h.\
METHODS	The pharmacodynamic effects measured were bleeding time ( BT ) , fibrinogen-binding at the GPIIb/IIIa-receptor ( FIB ) , expression of the platelet secretion marker CD62 , and ADP ( 20 microM ) - and collagen ( 5 microg ml ( -1 ) ) - induced platelet aggregation .\
RESULTS	After treatment with both GPIIb/IIIa-antagonists , prolongation of BT occurred to a similar magnitude ( approximately 25-30 min ) and was not affected by UFH or REV-comedication .\
RESULTS	ABC or T with ASA alone resulted in nearly the same magnitude of reduction in FIB and platelet aggregation .\
RESULTS	After coadministration with UFH , FIB was significantly higher ( thus less inhibited ) than after after T + ASA alone ( 19 + / - 16 % vs 55 + / - 36 % ) or ABC + ASA alone ( 8 + / - 9 % vs 32 + / - 11 % ) .\
RESULTS	This attenuation of FIB was not seen with REV. Inhibition of ADP-and collagen-induced aggregation tended to be attenuated by treatment with UFH ( e.g. ADP-induced aggregation at 0.25 h after ABC + ASA alone = 13 + / - 4 % ; after coadministration with UFH = 40 + / - 26 % ) .\
RESULTS	No such changes were noted with REV. Minor reductions in CD62-expression were seen in subjects given ABC or T alone , but expression was not affected by UFH or REV.\
CONCLUSIONS	Co-medication with UFH attenuated platelet inhibition during treatment with GPIIb/IIIa-antagonists , but these effects were not seen with the low molecular weight heparin reviparin .\
CONCLUSIONS	The results show that administration of reviparin together with abciximab or tirofiban did not adversely affect the pharmacodynamic profile of these GPIIb/IIIa-antagonists .\
\
###21323269\
OBJECTIVE	To compare functional and morphological outcomes of 1.8-mm versus 2.2-mm microincision coaxial cataract surgery ( MCCS ) .\
METHODS	Thirty eyes of 30 patients that underwent MCCS were randomized to two groups : 1.8-mm MCCS ( group 1 : 15 eyes ) and 2.2-mm MCCS ( group 2 : 15 eyes ) .\
RESULTS	There were no significant between-group differences in uncorrected visual acuity , best-corrected visual acuity , keratometric astigmatism , and endothelial cell count .\
RESULTS	One day postoperatively , a greater increase of corneal thickness at the incision site was observed in group 1 compared to group 2 using anterior segment optical coherence tomography with no significant differences in tunnel morphometric features and confocal microscopy showed more tunnel edema in group 1 versus group 2 that resolved in both groups .\
CONCLUSIONS	Both 1.8 - and 2.2-mm torsional MCCS were safe and efficient with easy surgical maneuvers and excellent functional and morphological results ; 1.8-mm MCCS induced slightly greater tunnel edema shortly after surgery that resolved in the medium term .\
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###22132138\
OBJECTIVE	There are safety issues associated with propofol use for flexible bronchoscopy ( FB ) .\
OBJECTIVE	The bispectral index ( BIS ) correlates well with the level of consciousness .\
OBJECTIVE	The aim of this study was to show that BIS-guided propofol infusion is safe and may provide better sedation , benefiting the patients and bronchoscopists .\
METHODS	After administering alfentanil bolus , 500 patients were randomized to either propofol infusion titrated to a BIS level of 65-75 ( study group ) or incremental midazolam bolus based on clinical judgment to achieve moderate sedation .\
METHODS	The primary endpoint was safety , while the secondary endpoints were recovery time , patient tolerance , and cooperation .\
RESULTS	The proportion of patients with hypoxemia or hypotensive events were not different in the 2 groups ( study vs. control groups : 39.9 % vs. 35.7 % , p = 0.340 ; 7.4 % vs. 4.4 % , p = 0.159 , respectively ) .\
RESULTS	The mean lowest blood pressure was lower in the study group .\
RESULTS	Logistic regression revealed male gender , higher American Society of Anesthesiologists physical status , and electrocautery were associated with hypoxemia , whereas lower propofol dose for induction was associated with hypotension in the study group .\
RESULTS	The study group had better global tolerance ( p < 0.001 ) , less procedural interference by movement or cough ( 13.6 % vs. 36.1 % , p < 0.001 ; 30.0 % vs. 44.2 % , p = 0.001 , respectively ) , and shorter time to orientation and ambulation ( 11.710.2 min vs. 29.726.8 min , p < 0.001 ; 30.018.2 min vs. 55.740.6 min , p < 0.001 , respectively ) compared to the control group .\
CONCLUSIONS	BIS-guided propofol infusion combined with alfentanil for FB sedation provides excellent patient tolerance , with fast recovery and less procedure interference .\
BACKGROUND	ClinicalTrials .\
BACKGROUND	gov NCT00789815 .\
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###20546592\
BACKGROUND	Cleaners are rarely introduced to workplace health promotion programs .\
BACKGROUND	The study 's objective was to evaluate the reach and adoption of a workplace randomized controlled trial ( RCT ) among cleaners in Denmark .\
METHODS	Cleaning businesses with at least 30 employees , that could offer a weekly 1-hour intervention during working hours , were invited to participate .\
METHODS	Employees working at least 20 hours/week were invited to answer a screening questionnaire and consent to participate .\
METHODS	Analyses determined the differences in health variables between responders and non-responders , consenters and non-consenters , participants and non-participants and between participants of the RCT 's three groups : physical coordination training , cognitive-behavioural theory-based training and reference group .\
RESULTS	From 16 eligible workplaces , a representative sample of 50 % adopted the trial .\
RESULTS	Of 758 eligible employees , 78 % responded to the screening questionnaire and 49 % consented to participate .\
RESULTS	Consenters and participants differed from non-consenters and non-participants by having higher BMI , more chronic diseases and poorer musculoskeletal health .\
CONCLUSIONS	This study indicates that workplace health promotion programs directed at health risk factors among cleaners enable significant adoption and reach to a high-risk subgroup of the Danish workforce .\
BACKGROUND	Trial registration ISRCTN96241850 .\
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###11788176\
OBJECTIVE	To determine the long-term effects of estrogen replacement therapy on sex hormone binding globuline ( SHBG ) and free testosterone ( fT ) levels in surgical postmenopausal women .\
METHODS	Forty patients with surgical menopause were enrolled in this prospective study .\
METHODS	The women were randomly divided into two groups .\
METHODS	The first group received oral therapy ( continuous conjugated equine estrogens ( CEE ) - 0.625 mg per day ) and the second group received transdermal therapy ( patches delivering continuous 17beta-estradiol ( E2 ) -- 0.05 mg per day ) .\
METHODS	Serum SHBG and fT levels were determined at baseline and after first and second years of treatment .\
METHODS	Two-way repeated measures analysis of variance with Bonferroni adjusted post-hoc test and unpaired-t-test were performed for statistical analysis with SPSS program .\
RESULTS	Serum SHBG levels increased significantly with oral CEE after first year of treatment ( P < 0.05 ) and remained at this level for the next year .\
RESULTS	Transdermal therapy did not affect SHBG levels after first and second years ( P < 0.05 ) .\
RESULTS	Serum fT levels did not change significantly in either group at the end of the first or second years ( P < 0.05 ) although there was a significant difference between the groups after 2 years ( P < 0.05 ) .\
CONCLUSIONS	Oral conjugated estrogens increased SHBG levels during therapy .\
CONCLUSIONS	This effect may balance the increased estrogen and androgen stimulation on breast tissue and may be more beneficial to the cardiovascular system in postmenopausal women .\
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###23624172\
BACKGROUND	The childhood obesity epidemic disproportionately affects Hispanics .\
BACKGROUND	This paper reports on the design of the ongoing Healthy Families Study , a randomized controlled trial testing the efficacy of a community-based , behavioral family intervention to prevent excessive weight gain in Hispanic children using a community-based participatory research approach .\
METHODS	The study will enroll 272 Hispanic families with children ages 5-7 residing in greater Nashville , Tennessee , United States .\
METHODS	Families are randomized to the active weight gain prevention intervention or an alternative intervention focused on oral health .\
METHODS	Lay community health promoters implement the interventions primarily in Spanish in a community center .\
METHODS	The active intervention was adapted from the We Can !\
METHODS	parent program to be culturally-targeted for Hispanic families and for younger children .\
METHODS	This 12-month intervention promotes healthy eating behaviors , increased physical activity , and decreased sedentary behavior , with an emphasis on parental modeling and experiential learning for children .\
METHODS	Families attend eight bi-monthly group sessions during four months then receive information and/or support by phone or mail each month for eight months .\
METHODS	The primary outcome is change in children 's body mass index .\
METHODS	Secondary outcomes are changes in children 's waist circumference , dietary behaviors , preferences for fruits and vegetables , physical activity , and screen time .\
RESULTS	Enrollment and data collection are in progress .\
CONCLUSIONS	This study will contribute valuable evidence on efficacy of a childhood obesity prevention intervention targeting Hispanic families with implications for reducing disparities .\
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###19125756\
OBJECTIVE	To determine the short-term effect of vitamin D ( 3 ) supplementation on insulin sensitivity in apparently healthy , middle-aged , centrally obese men .\
METHODS	A double-blind randomized controlled trial was conducted at a tertiary care facility in which 100 male volunteers aged > or = 35 years received three doses of vitamin D ( 3 ) ( 120,000 IU each ; supplemented group ) fortnightly or placebo ( control group ) .\
METHODS	Hepatic fasting insulin sensitivity [ homeostasis model assessment ( HOMA ) , quantitative insulin-sensitivity check index , HOMA-2 ] , postprandial insulin sensitivity [ oral glucose insulin sensitivity ( OGIS ) ] , insulin secretion ( HOMA % B , HOMA2 - % B ) , lipid profile and blood pressure were measured at baseline and at 6 weeks ' follow-up .\
RESULTS	Seventy-one of the recruited subjects completed the study ( 35 in supplemented group , 36 in control group ) .\
RESULTS	There was an increase in OGIS with supplementation by per protocol analysis ( P = 0.038 ; intention-to-treat analysis P = 0.055 ) .\
RESULTS	The age - and baseline 25-hydroxyvitamin D level-adjusted difference in change in OGIS was highly significant ( mean difference 41.1 + / - 15.5 ; P = 0.01 ) .\
RESULTS	No changes in secondary outcome measures ( insulin secretion , basal indices of insulin sensitivity , blood pressure or lipid profile ) were found with supplementation .\
CONCLUSIONS	The trial indicates that vitamin D ( 3 ) supplementation improves postprandial insulin sensitivity ( OGIS ) in apparently healthy men likely to have insulin resistance ( centrally obese but non-diabetic ) .\
\
###9852438\
OBJECTIVE	Previous studies of monochromatic visual evoked potentials confirm the strong suppression of ( the cortical representation of ) paracentral retinal areas of functionally amblyopic eyes , by a flat response to a blue stimulus .\
OBJECTIVE	A clinical trial stimulating these areas with blue light was encouraging , and justified a prospective comparison of this treatment with conventional classic treatment .\
METHODS	In 50 strabismic children with amblyopia , the blue filter treatment protocol ( flash stimulation with , and the wearing of , a blue filter during occlusion of the better eye for one hour daily ) was compared with the classical treatment ( full time total occlusion by patch ) in a prospective matched and randomized study .\
METHODS	Patients 3 to 7 years old without previous treatment and a visual acuity up to 0.3 were admitted to the study .\
METHODS	Visual acuity and fixation behavior were used as the parameters of comparison .\
METHODS	Visual Evoked Potentials by monochromatic flashes were also studied .\
METHODS	Results of treatment were compared after 6 months .\
RESULTS	The visual acuity outcome for the blue filter treatment was `` statistically significantly '' better ( p = 0.005 ) .\
RESULTS	The greatest improvement was seen in the subgroup of children with eccentric fixation ( p = 0.01 ) .\
RESULTS	Fixation behavior also showed a better outcome from the blue filter treatment ( p = 0.05 ) favoring especially children between 3 and 5 years .\
RESULTS	In children of this age with a visual acuity better than 0.1 we found a very `` statistically significant '' difference between the two treatments ( p = 0.004 ) .\
RESULTS	In children 3 to 5 years old with poorer visual acuity we also found a `` statistically significant '' difference in the two treatments ( p = 0.04 ) .\
RESULTS	The interocular difference of amplitude on the Visual Evoked Potentials also demonstrated more improvement in children treated with the blue filter .\
RESULTS	This treatment improved especially the cortical response to blue flash stimulation , correlating to paracentral retinal areas .\
CONCLUSIONS	The blue filter treatment protocol provided better results for treating amblyopia than the conventional classic occlusion treatment method .\
CONCLUSIONS	We propose that stimulation of these paracentral retinal areas triggers a better disinhibition of a functionally amblyopic eye .\
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###9051389\
OBJECTIVE	To evaluate the efficacy and safety of oral treatment with the antioxidant alpha-lipoic acid ( ALA ) in NIDDM patients with cardiac autonomic neuropathy ( CAN ) , assessed by heart rate variability ( HRV ) .\
METHODS	In a randomized , double-blind placebo-controlled multicenter trial ( Deutsche Kardiale Autonome Neuropathie [ DEKAN ] Study ) , NIDDM patients with reduced HRV were randomly assigned to treatment with daily oral dose of 800 mg ALA ( n = 39 ) or placebo ( n = 34 ) for 4 months .\
METHODS	Parameters of HRV at rest included the coefficient of variation ( CV ) , root mean square successive difference ( RMSSD ) , and spectral power in the low-frequency ( LF ; 0.05-0 .15 Hz ) and high-frequency ( HF ; 0.15-0 .5 Hz ) bands .\
METHODS	In addition , cardiovascular autonomic symptoms were assessed .\
RESULTS	Seventeen patients dropped out of the study ( ALA n = 10 ; placebo n = 7 ) .\
RESULTS	Mean blood pressure and HbA1 levels did not differ between the groups at baseline and during the study , but heart rate at baseline was higher in the group treated with ALA ( P < 0.05 ) .\
RESULTS	RMSSD increased from baseline to 4 months by 1.5 ms ( -37.6 to 77.1 ) [ median ( minimum-maximum ) ] in the group given ALA and decreased by -0.1 ms ( -19.2 to 32.8 ) in the placebo group ( P < 0.05 for ALA vs. placebo ) .\
RESULTS	Power spectrum in the LF band increased by 0.06 bpm2 ( -0.09 to 0.62 ) in ALA , whereas it declined by -0.01 bpm2 ( -0.48 to 1.86 ) in placebo ( P < 0.05 for ALA vs. placebo ) .\
RESULTS	Furthermore , there was a trend toward a favorable effect of ALA versus placebo for the CV and HF band power spectrum ( P = 0.097 and P = 0.094 for ALA vs. placebo ) .\
RESULTS	The changes in cardiovascular autonomic symptoms did not differ significantly between the groups during the period studied .\
RESULTS	No differences between the groups were noted regarding the rates of adverse events .\
CONCLUSIONS	These findings suggest that treatment with ALA using a well-tolerated oral dose of 800 mg/day for 4 months may slightly improve CAN in NIDDM patients .\
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###18554189\
OBJECTIVE	To evaluate human pulp tissue response following direct pulp capping with a self-etching adhesive : Clearfil SE BOND ( SB ) .\
METHODS	Forty-five sound teeth from 20 subjects were used .\
METHODS	Forty-one teeth had their pulp mechanically exposed at the base of a Class 1 cavity preparation and were divided into two groups : group 1 , teeth were capped with SB ( n = 21 ) , and group 2 , with calcium hydroxide cement ( CH ) ( n = 20 ) .\
METHODS	Four teeth were maintained intact as an untreated control group .\
METHODS	After 7 , 30 and 90 days , respectively , 15 teeth were extracted and processed for light microscopic examination .\
METHODS	Pulp healing and bacterial microleakage were assessed by haematoxylin and eosin , Masson trichrome and Brown and Brenn stain techniques .\
METHODS	The data were analysed statistically by using the Mann-Whitney U test .\
RESULTS	After the 7-day observation period , the inflammatory reaction in the SB group was slight and significantly less severe than that of the CH group ( P < 0.05 ) .\
RESULTS	After the 30 - and 90-day observation periods , the inflammatory reaction was slight in both groups , but specimens with dentine bridge formation in the SB group were significantly less common than those in the CH group ( P < 0.05 ) .\
CONCLUSIONS	Clearfil SB had good biocompatibility with human pulp tissue , but its ability to induce reparative dentine was significantly lower than that of calcium hydroxide .\
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###23149503\
BACKGROUND	Implants were first designed to be used in the reconstruction of edentulous mandibles .\
BACKGROUND	However , with the technological advancement , enormous changes were made to improve the implant design and surface characteristics leading to the wide use of implants in the replacement of missing teeth .\
BACKGROUND	During the transition from an edentulous span to a fixed prosthesis , narrow body implants ( NBIs ) have been proposed to enhance patient comfort and function .\
BACKGROUND	Therefore , this study was aimed at investigating the survival and success rates of NBIs used for supporting immediately nonfunctional loaded provisional fixed partial denture ( PFPD ) .\
METHODS	Either 2.2 - or 2.4-mm-diameter dental implants were placed transmucosally into the edentulous ridges of 10 partially edentulous patients .\
METHODS	PFPD of self-cured bis-acryl composite material were made using either a vacuform template chairside or a relined prefabricated PFPD .\
METHODS	Occlusal adjustments were made to ensure that there was no functional loading on the provisional restorations before they were secured onto the transitional implants .\
RESULTS	At 1 year , the implant success and survival rates were 38.7 % and 93.5 % , respectively , with a mean percentage of bone loss of 9.46 % ( 0 % -40 % ) and a mean bone loss of 1.19 mm ( range : 0-3 .5 mm ) .\
CONCLUSIONS	With a favorable implant survival rate , the use of NBIs to support provisional restorations seemed to be a feasible treatment option .\
CONCLUSIONS	In addition , there is merit for research on the long-term use of NBIs-supported final prostheses .\
\
###19472447\
OBJECTIVE	To examine the efficacy of rizatriptan 10-mg orally disintegrating tablet ( ODT ) for treating migraines of mild intensity soon after onset , with or without patient-specific migraine education .\
BACKGROUND	Studies have shown rizatriptan tablet efficacy in early migraine treatment .\
METHODS	In this randomized , placebo-controlled , double-blind , factorial design study , adults with a history of migraine were assigned to rizatriptan 10-mg ODT patient education ( personalized summary of early migraine signs and symptoms ) or placebo patient education in a 1 : 1 : 1 : 1 ratio .\
METHODS	Patients were instructed to treat 1 attack at the earliest time they knew that their headache was a migraine , while pain was mild .\
METHODS	During the next 24 hours , patients assessed pain severity , associated symptoms , functional disability , use of rescue medication , and treatment satisfaction .\
METHODS	The primary endpoint was pain freedom at 2 hours ; a key secondary endpoint was 24-hour sustained pain freedom .\
RESULTS	Of 207 patients randomized to treatment , 188 ( 91 % ) treated a study migraine .\
RESULTS	Significantly more patients taking rizatriptan reported pain freedom at 2 hours compared with placebo ( 66.3 % vs 28.1 % , P < .001 ) .\
RESULTS	Similarly , significantly more patients taking rizatriptan reported 24-hour sustained pain freedom ( 52.2 % vs 17.7 % , P < .001 ) .\
RESULTS	A greater proportion of patients in the rizatriptan + education group reported pain freedom at 2 hours compared with those in the rizatriptan + no education group ( 71.7 % vs 60.9 % , P = .430 ) .\
RESULTS	Few adverse events were reported .\
CONCLUSIONS	Rizatriptan 10-mg ODT , when taken early , while headache pain is mild , was superior to placebo at providing pain freedom at 2 hours and 24-hour sustained pain freedom .\
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###18338161\
OBJECTIVE	This study was performed to determine whether students who are trained in developing a personal formulary become more competent in rational prescribing than students who have only learned to use existing formularies .\
METHODS	This was a multicentre , randomised , controlled study conducted in eight universities in India , Indonesia , the Netherlands , the Russian Federation , Slovakia , South Africa , Spain and Yemen .\
METHODS	Five hundred and eighty-three medical students were randomised into three groups : the personal formulary group ( PF ; 94 ) , the existing formulary group ( EF ; 98 ) and the control group ( C ; 191 ) .\
METHODS	The PF group was taught how to develop and use a personal formulary , whereas e the EF group was taught how to review and use an existing formulary .\
METHODS	The C group received no additional training and participated only in the tests .\
METHODS	Student 's prescribing skills were measured by scoring their treatment plans for written patient cases .\
RESULTS	The mean PF group score increased by 23 % compared with 19 % for the EF group ( p < 0.05 ) and 6 % for controls ( p < 0.05 ) .\
RESULTS	The positive effect of PF training was only significant in universities that had a mainly classic curriculum .\
CONCLUSIONS	Training in development and use of a personal formulary was particularly effective in universities with a classic curriculum and with traditional pharmacology teaching .\
CONCLUSIONS	In universities with a general problem-based curriculum , pharmacotherapy teaching can be based on either existing or personal formularies .\
\
###7707111\
OBJECTIVE	While tamoxifen has been shown to alter concentration of many hormones and their binding globulins , there have been conflicting results regarding its effects on thyroid function tests .\
OBJECTIVE	We sought to clarify these effects by studying subjects in a controlled clinical trial .\
METHODS	We evaluated a subset of postmenopausal women who had participated in a longitudinal , double-blind , randomized , placebo-controlled toxicity study of tamoxifen 10 mg orally , twice daily .\
METHODS	There were 14 subjects in both the tamoxifen and placebo groups .\
METHODS	Measurement of thyroid-binding globulin ( TBG ) , thyroxine uptake ( T-Uptake ) , thyroxine ( T4 ) , and thyroid-stimulating hormone ( TSH ) , and an indirect estimate of the free T4 index ( FTI ) , were made for each subject before and after 3 months of treatment .\
RESULTS	For T-Uptake , T4 , and TBG , there were significant increases in the mean change from baseline to 3 months in the tamoxifen group compared with the placebo group ( P = .02 , .0001 , and .003 , respectively ) , while there were no significant changes in the measured TSH and in the calculated FTI .\
CONCLUSIONS	We conclude that tamoxifen therapy in postmenopausal women results in increased TBG , with secondary increases in measured T-Uptake and T4 following .\
CONCLUSIONS	However , TSH and FTI levels are unchanged , and treated women remain eumetabolic .\
\
###17584555\
BACKGROUND	In nondiabetic patients with stable angina , combined treatment with hemodynamic agents and trimetazidine is well-tolerated and effective in controlling ischemia .\
BACKGROUND	This study aims to evaluate the antiischemic and metabolic effects of trimetazidine in patients with type 2 diabetes mellitus , not eligible for revascularization , who remained symptomatic despite the use of at least 2 antianginal agents .\
METHODS	A randomized , double-blind , crossover clinical trial was used .\
METHODS	Ten patients were randomized to receive trimetazidine ( 20 mg , 3 times a day ) or placebo for 6-week periods .\
METHODS	At baseline and at the end of each 6-week intervention period , clinical and biochemical evaluations , exercise testing , 24-hour ambulatory blood pressure , and Holter monitoring were performed .\
RESULTS	During trimetazidine therapy , patients had significant improvement on angina functional class ( P < .05 ) , with decrease in the number of weekly angina episodes ( 1.5 + / - 0.8 vs 0.4 + / - 0.7 , P < .01 ) , and in sublingual nitrate doses ( 1.4 + / - 0.7 mg vs 0.1 + / - 0.3 mg , P < .001 ) .\
RESULTS	Time to 1-mm ST-segment depression during exercise test was increased after trimetazidine use ( 229 + / - 126 seconds at baseline , 276 + / - 101 seconds after placebo , and 348 + / - 145 seconds after trimetazidine , P < .001 ) .\
RESULTS	No differences were observed between treatment periods on mean 24-hour blood pressure , heart rate , and rate-pressure product evaluated concomitantly with ambulatory blood pressure and Holter monitoring .\
RESULTS	Glycemic and lipid profiles were similar after trimetazidine and placebo use .\
CONCLUSIONS	In patients with diabetes who remain symptomatic , the addition of trimetazidine improves symptoms and exercise responses without hemodynamic or metabolic changes .\
CONCLUSIONS	The present data suggest that trimetazidine may be an effective adjunct therapy for these patients , but further investigation is needed to confirm these findings .\
\
###12875348\
OBJECTIVE	To assess the bioequivalence of 2 oral isotretinoin ( 20 mg ) soft gel capsule formulations .\
OBJECTIVE	The reference preparation was Roaccutan/Roche while the test preparation was A-Cnotren/Pharmaten , Athens , Greece .\
METHODS	The study was an open , randomized , 2-period , 2-sequence , 2-treatment crossover , involving 38 healthy male volunteer subjects .\
METHODS	All volunteers completed the study .\
METHODS	Isotretinoin plasma concentrations were measured by a fully validated HPLC method .\
METHODS	Special care was taken through the collection and analysis of the samples due to instability of isotretinoin to light and temperature .\
METHODS	Pharmacokinetic parameters used to assess bioequivalence were AUC ( 0-last ) , AUC ( 0-infinity ) for the extent of absorption and Cmax and Tmax for the rate of absorption .\
METHODS	Statistical evaluation of Cmax , AUC ( 0-last ) , AUC ( 0-infinity ) was done after semi-logarithmic transformation by 2-way analysis of variance ( ANOVA ) .\
METHODS	Tmax values were tested using the distribution-free Hodges-Lehman interval .\
RESULTS	The parametric 90 % confidence intervals for ratio T/R ranged from 95.20-103 .20 % ( point estimate 99.10 % ) for AUC ( 0-last ) , 94.57-102 .30 % ( point estimate 98.36 % ) for AUC ( 0-infinity ) and 94.81-102 .90 % ( point estimate 98.77 % ) for Cmax , respectively .\
RESULTS	Based on the results of Tmax , k ( el ) and t ( 1/2 ) , too , there were no statistically significant differences .\
CONCLUSIONS	As a result , the 2 isotretinoin preparations in accordance with the European Union bioequivalence requirements , are equivalent with respect to rate and extent of absorption .\
\
###23021156\
BACKGROUND	Men diagnosed with localized prostate cancer ( LPC ) can choose from multiple treatment regimens and are faced with a decision in which medical factors and personal preferences are important .\
BACKGROUND	The Personal Patient Profile-Prostate ( P3P ) is a computerized decision aid for men with LPC that focuses on personal preferences .\
BACKGROUND	We determined whether the P3P intervention improved the concordance of treatment choice with self-reported influential side-effects compared with a control group .\
METHODS	English/Spanish-speaking men diagnosed with LPC ( 2007-2009 ) from four US cities were enrolled into a randomized trial and followed through 6-months via mailed or online questionnaire .\
METHODS	Men were randomized to receive the P3P intervention or standard education plus links to reputable websites .\
METHODS	We classified choice as concordant if men were concerned with ( a ) sexual function and chose external beam radiotherapy or brachytherapy , ( b ) bowel function and chose prostatectomy , ( c ) sex , bowel , and/or bladder function and chose active surveillance , or ( d ) not concerned with any side effect and chose any treatment .\
METHODS	Using logistic regression , we calculated odds ratios ( OR ) and 95 % confidence intervals ( CI ) for the association between the P3P intervention and concordance .\
RESULTS	Of 448 men , most were < 65 years , non-Hispanic white , had multiple physician consultations prior to enrollment , and chose a treatment discordant with concerns about potential side effects .\
RESULTS	There was no significant difference in concordance between the intervention ( 45 % ) and control ( 50 % ) group ( OR = 0.82 ; 95 % CI = 0.56 , 1.2 ) .\
CONCLUSIONS	The P3P intervention did not improve concordance between potential side effects and treatment choice .\
CONCLUSIONS	Information and/or physician consultation immediately after diagnosis was likely to influence decisions despite concerns about side effects .\
CONCLUSIONS	The intervention may be more effective before the first treatment options consultation .\
BACKGROUND	NCT00692653 http://clinicaltrials.gov/ct2/show/NCT00692653 .\
\
###21320950\
OBJECTIVE	To determine whether intra-arterial chemotherapy is safe and effective in advanced intraocular retinoblastoma .\
OBJECTIVE	Retinoblastoma often presents with advanced intraocular disease and , despite conventional treatment with intravenous chemotherapy and external beam radiation therapy , may still require enucleation .\
METHODS	Single-arm , prospective registry from May 30 , 2006 , to May 30 , 2010 , at an ophthalmic oncology referral center with ambulatory care .\
METHODS	A total of 95 eyes of 78 patients with unilateral or bilateral retinoblastoma were treated .\
METHODS	The intervention was selective catheterization of the ophthalmic artery and injection of chemotherapy , usually melphalan with or without topotecan .\
METHODS	Drug dosage was determined by age and angioanatomy .\
METHODS	The main outcome measures were procedural success , event-free ( enucleation or radiotherapy ) ocular survival , and ocular and extraocular complications .\
RESULTS	Catheterization succeeded in 98.5 % of procedures .\
RESULTS	There were 289 chemotherapy injections ( median , 3 per eye ) .\
RESULTS	The Kaplan-Meier estimates of ocular event-free survival rates at 2 years were 70.0 % ( 95 % confidence interval , 57.9 % -82.2 % ) for all eyes , 81.7 % ( 95 % confidence interval , 66.8 % -96.6 % ) for eyes that received intra-arterial chemotherapy as primary treatment , and 58.4 % ( 95 % confidence interval , 39.5 % -77.2 % ) for eyes that had previous treatment failure with intravenous chemotherapy and/or external beam radiation therapy .\
RESULTS	There were no permanent extraocular complications .\
CONCLUSIONS	Our experience suggests that intra-arterial chemotherapy is safe and effective in the treatment of advanced intraocular retinoblastoma .\
\
###25126867\
OBJECTIVE	Hypertension remains a significant risk factor in cardiovascular morbidity and mortality .\
OBJECTIVE	The purpose of the present study was to investigate the effects of 8 weeks interval training programme on blood pressure , aerobic capacity ( VO max ) , indices of adiposity and marker of inflammation in black African men with essential hypertension .\
METHODS	Two hundred and forty five ( 245 ) male subjects with stage 1 and 2 ( systolic blood pressure [ SBP ] between 140-179 & diastolic blood pressure [ DBP ] between 90-109 mmHg ) essential hypertension were age matched and grouped into experimental and control groups .\
METHODS	The experimental ( n = 140 ; 58.90 7.35 years ) group involved in an 8 weeks interval training ( 60-79 % HRmax ) programme of between 45 and 60 minutes , while age-matched control hypertensive ( n = 105 ; 58.276.24 years ) group remain sedentary during this period .\
METHODS	All subjects in both groups were on antihypertensive drugs throughout the study period .\
METHODS	Cardiovascular parameters ( SBP , DBP ) & VO max and percent body fat [ % BF ] , waist to hip ratio [ WHR ] and C-reactive protein [ CRP ] were assessed .\
METHODS	Independent t-test and Pearson correlation test were used in data analysis .\
RESULTS	Findings of the study revealed significant decreased effects of interval training programme on SBP , DBP , % BF , WHR and CRP and significant increased effect on VO max at p < 0.05 .\
RESULTS	Also , changes in CRP as a result of exercise training significantly and positively correlated with changes in SBP , DBP , % BF , WHR , CRP and negatively correlated with VO max at p < 0.05 .\
\
###11573114\
OBJECTIVE	The present in vivo study evaluates the efficacy of sulphadoxine/pyrimethamine , doxycycline and their combination in the treatment of Sudanese patients infected by chloroquine resistant falciparum malaria .\
METHODS	Febrile patients with positive blood smears of Plasmodium falciparum were given chloroquine 25mg-base/kg body weight and followed up for 3 days .\
METHODS	Patients with recrudescence due to chloroquine resistance were readmitted for test treatment .\
METHODS	Using simple number randomization patients were divided into groups , A , B and C.\
METHODS	These were treated with doxycycline , sulphadoxine / pyrimethamine and a combination therapy of sulphadoxine/pyrimethamine plus doxycycline .\
METHODS	Doxycycline was initially administered as a single dose of 200mg followed by 100mg daily for 6 days whereas sulphadoxine/pyrimethamine was given as a single dose of sulphadoxine 1500mg and pyrimethamine 75mg .\
METHODS	Patients of group C received the combination therapy of sulphadoxine/pyrimethamine and doxycycline .\
METHODS	Clinical observations and examination of blood films were carried out for each patient daily for 6 days and thereafter weekly for 4 weeks .\
RESULTS	A high level of chloroquine resistance ( 75 % ) was documented amongst 280 patients ( age 15-53 years ) visiting Omdurman Hospital of Endemic Diseases during 1996-1998 .\
RESULTS	The study demonstrated that only 46 % and 78 % of the patients were cured after 4 days of treatment by doxycycline and sulphadoxine/pyrimethamine .\
RESULTS	Patients treated with sulphadoxine/pyrimethamine in combination with doxycycline had a cure rate of 90 % and 100 % after 3-4 days of treatment , a single recrudescent case was detected on day 6 .\
RESULTS	No relapses occurred during the follow up period .\
RESULTS	All patients were successfully treated by all regimens with the exception of one case treated by doxycycline .\
RESULTS	All treatments were well tolerated but a few cases had complaints of nausea .\
CONCLUSIONS	The combination therapy of doxycycline/sulphadoxine/pyrimethamine appeared to be significantly effective in the treatment of patients with chloroquine resistant falciparum malaria without causing any serious side effects .\
CONCLUSIONS	Such a combination regimen has the advantages of being available at a reasonable cost and less prone to development of resistance .\
\
###24139668\
BACKGROUND	Simulation-based learning is a common educational tool in health care training and frequently involves instructional designs based on Experiential Learning Theory ( ELT ) .\
BACKGROUND	However , little research explores the effectiveness and efficiency of different instructional design methodologies appropriate for simulations .\
BACKGROUND	The aim of this study was to compare 2 instructional design models , ELT and Guided Experiential Learning ( GEL ) , to determine which is more effective for training the central venous catheterization procedure .\
METHODS	Using a quasi-experimental randomized block design , nurse anesthetists completed training under 1 of the 2 instructional design models .\
METHODS	Performance was assessed using a checklist of central venous catheterization performance , pass rates , and critical action errors .\
RESULTS	Participants in the GEL condition performed significantly better than those in the ELT condition on the overall checklist score after controlling for individual practice time ( F [ 1 , 29 ] = 4.021 , P = .027 , Cohen 's d = .71 ) , had higher pass rates ( P = .006 , Cohen 's d = 1.15 ) , and had lower rates of failure due to critical action errors ( P = .038 , Cohen 's d = .81 ) .\
CONCLUSIONS	The GEL model of instructional design is significantly more effective than ELT for simulation-based learning of the central venous catheterization procedure , yielding large differences in effect size .\
\
###24041479\
BACKGROUND	Depression is a worldwide problem warranting global solutions to tackle it .\
BACKGROUND	Enhancing well-being has benefits in its own right and could be a good strategy for preventing depression .\
BACKGROUND	Providing well-being interventions via the Internet may have synergetic effects .\
OBJECTIVE	Psyfit ( `` mental fitness online '' ) is a fully automated self-help intervention to improve well-being based on positive psychology .\
OBJECTIVE	This study examines the clinical effects of this intervention .\
METHODS	We conducted a 2-armed randomized controlled trial that compared the effects of access to Psyfit for 2 months ( n = 143 ) to a waiting-list control condition ( n = 141 ) .\
METHODS	Mild to moderately depressed adults in the general population seeking self-help were recruited .\
METHODS	Primary outcome was well-being measured by Mental Health Continuum-Short Form ( MHC-SF ) and WHO Well-being Index ( WHO-5 ) ; secondary outcomes were depressive symptoms , anxiety , vitality , and general health measured by Center for Epidemiological Studies Depression Scale ( CES-D ) , Hospital Anxiety and Depression Scale Anxiety subscale ( HADS-A ) , and Medical Outcomes Study-Short Form ( MOS-SF ) vitality and general health subscales , respectively .\
METHODS	Online measurements were taken at baseline , 2 months , and 6 months after baseline .\
RESULTS	The dropout rate was 37.8 % in the Psyfit group and 22.7 % in the control group .\
RESULTS	At 2-month follow-up , Psyfit tended to be more effective in enhancing well-being ( nonsignificantly for MHC-SF : Cohen 's d = 0.27 , P = .06 ; significantly for WHO-5 : Cohen 's d = 0.31 , P = .01 ) , compared to the waiting-list control group .\
RESULTS	For the secondary outcomes , small but significant effects were found for general health ( Cohen 's d = 0.14 , P = .01 ) , vitality ( d = 0.22 , P = .02 ) , anxiety symptoms ( Cohen 's d = 0.32 , P = .001 ) , and depressive symptoms ( Cohen 's d = 0.36 , P = .02 ) .\
RESULTS	At 6-month follow-up , there were no significant effects on well-being ( MHC-SF : Cohen 's d = 0.01 , P = .90 ; WHO-5 : Cohen 's d = 0.26 , P = .11 ) , whereas depressive symptoms ( Cohen 's d = 0.35 , P = .02 ) and anxiety symptoms ( Cohen 's d = 0.35 , P = .001 ) were still significantly reduced compared to the control group .\
RESULTS	There was no clear dose-response relationship between adherence and effectiveness , although some significant differences appeared across most outcomes in favor of those completing at least 1 lesson in the intervention .\
CONCLUSIONS	This study shows that an online well-being intervention can effectively enhance well-being ( at least in the short-term and for 1 well-being measure ) and can help to reduce anxiety and depression symptoms .\
CONCLUSIONS	Further research should focus on increasing adherence and motivation , reaching and serving lower-educated people , and widening the target group to include people with different levels of depressive symptoms .\
BACKGROUND	Netherlands Trial Register ( NTR ) number : NTR2126 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2126 ( archived by WebCite at http://www.webcitation.org/6IIiVrLcO ) .\
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###23575594\
OBJECTIVE	New national and state preventive health investments have provided significant funding for local governments ( LGs ) to be involved in planning and implementing health promotion interventions .\
OBJECTIVE	There is an expectation that this work is evidence based ; however , inadequate support and systems exist for evidence-informed planning and decision making in LGs .\
OBJECTIVE	Previous initiatives have aimed to build capacity and leadership in LG health promotion , but the training , support and infrastructure have been sporadic .\
METHODS	Across 2009-11 we implemented a National Health and Medical Research Council of Australia ( NHMRC ) - funded university-LG research project to explore the feasibility , usefulness and outcomes of a knowledge translation ( KT ) intervention to increase the use of evidence in LGs .\
METHODS	Within this exploratory cluster randomised controlled trial , one strategy being evaluated was workforce capacity building , during which group discussions revealed contextual challenges in delivering evidence-informed health promotion within the current funding context .\
METHODS	Discussion was recorded .\
METHODS	The group acknowledged the need to identify barriers and realistic practical solutions , and to communicate these more broadly .\
RESULTS	Barriers to sourcing and applying evidence to inform health promotion emerged from discussions with LG representatives .\
RESULTS	System-level contextual factors affecting decisions were also discussed , namely concerns about organisational capacity and ` culture ' to plan , implement and evaluate effective initiatives in LGs .\
RESULTS	Possible solutions suggested included : systems for access to academic literature ; processes that make it easier to use evidence ; training in evidence-informed health promotion to build organisational culture and capacity ; and research-practice partnerships and mentoring .\
CONCLUSIONS	Targeted strategies with individuals ( LG staff ) and organisations ( leadership , systems ) are needed to realise the potential of current health promotion investments .\
CONCLUSIONS	Research-practice partnerships are likely to be important .\
CONCLUSIONS	It seems obvious that it is impossible to be evidence informed without mechanisms to access and apply evidence .\
CONCLUSIONS	We invite other LGs to reflect upon their experiences in such initiatives , and to consider whether the strategies we propose may be useful .\
CONCLUSIONS	So what ?\
CONCLUSIONS	The increased emphasis on health promotion and non-communicable disease prevention programs may be limited by the capacity , confidence and organisational culture to inform policies and programs with best-available evidence .\
CONCLUSIONS	We describe some of the current challenges and contextual factors as they are being experienced .\
CONCLUSIONS	There are opportunities for national and state governments , organisations representing local government ( e.g. municipal associations ) and research partners to provide targeted support to councils .\
CONCLUSIONS	This may assist in achieving effective health promotion at the community level .\
\
###15822086\
OBJECTIVE	Recent research offers conflicting views of whether women high in dietary restraint are inspired or demoralized after viewing thin-ideal images .\
OBJECTIVE	We conducted two studies to explore the impact of diet commercials featuring the thin-ideal image on snack food consumption .\
METHODS	In Study 1 , 91 high school women watched a sad movie interrupted with diet or neutral commercials .\
METHODS	In Study 2 , 102 college women saw diet commercials early or midway through a sad movie .\
RESULTS	In Study 1 , high restraint participants consumed more snacks after exposure to diet commercials than to neutral commercials .\
RESULTS	In Study 2 , early commercials reduced snacking in low restraint women but not in high restraint women .\
CONCLUSIONS	Thin-ideal images embedded in diet commercials do not inspire high restraint women but can modify the eating of low restraint women .\
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###23954277\
BACKGROUND	This prospective , randomized , double-blind , multicenter study compared the efficacy and safety of Celecoxib and GCSB-5 , a new product from extracts of six herbs , for the treatment of knee osteoarthritis .\
METHODS	A total of 198 eligible patients were randomly assigned to the Celecoxib group ( n = 99 patients ) or the GCSB-5 group ( n = 99 patients ) for the 12-week study .\
METHODS	The amount of change and percentage of the change in Western Ontario and McMaster Universities ( WOMAC ) Arthritis Index from the baseline , the change in pain on walking by visual analogue scale ( VAS ) , physician 's global assessment on response to therapy ( PGART ) by five point Likert scale , and the amount of rescue medicine taken were used as parameters for efficacy .\
METHODS	Adverse drug reactions ( ADRs ) were carefully investigated .\
RESULTS	The WOMAC score improved in both the Celecoxib group and GCSB-5 group by 20.5 and 21.3 ( P = 0.79 ) .\
RESULTS	The percentage of the change in WOMAC score were -42.0 % and -38.9 % ( P = 0.54 ) .\
RESULTS	The pain VAS score decreased by 29.9 and 27.9 ( P = 0.58 ) .\
RESULTS	The responders by PGART were 95.3 % and 93.8 % ( P = 0.66 ) , and the median amount of rescue medicine taken were 2.0 and 6.5 tablets ( P = 0.06 ) .\
RESULTS	The incidence of ADRs were 31.3 % and 21.2 % ( P = 0.11 ) .\
RESULTS	The most common ADRs were gastrointestinal system related ; 17.2 % in GCSB-5 group and 22.2 % in Celecoxib group .\
RESULTS	Any severe ADR was not observed in either group .\
CONCLUSIONS	The result of this study supports that GCSB-5 is comparable to Celecoxib in terms of the efficacy and safety for the treatment of osteoarthritis of knee joint .\
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###22569014\
BACKGROUND	Epinephrine is a commonly used vasoconstrictor for instillation or infiltration to limit bleeding and improve the quality of the surgical field in functional endoscopic sinus surgery ( FESS ) .\
BACKGROUND	No study to date has shown the efficacy of varying concentrations of adrenaline wicks into the nasal mucosa during FESS .\
METHODS	A prospective , randomized , double-blind pilot study was conducted in which 30 American Society of Anesthesiologists ( ASA ) class I and II patients aged 20 to 60 years were divided into two groups .\
METHODS	Patients in group 1 and 2 received 1 and 4 mg of epinephrine , respectively , with a nasal pack soaked in 20 mL of saline for 10 minutes before surgery after induction of anesthesia .\
METHODS	A standard anesthesia protocol was followed using morphine , propofol , vecuronium with oxygen , and nitrous oxide .\
METHODS	Patients were monitored for assessment of the surgical field and the amount of blood loss during FESS .\
METHODS	Patients were also monitored for heart rate , invasive blood pressure , and cardiac output to assess the safety of varying concentrations of adrenaline wicks .\
METHODS	Blood loss was measured meticulously .\
METHODS	The surgical field was assessed by a surgeon blinded to the patient group using the Boezaart scale .\
METHODS	Hemodynamic instability ( 20 % of baseline values ) was treated by rescue drugs ( nitroglycerin infusion , metoprolol ) .\
RESULTS	Blood loss was found to be significantly decreased in group 2 compared to group 1 ( p < .05 ) .\
RESULTS	The rescue medication requirement to treat hypertension was more in group 2 than in group 1 ( p < .05 ) but within the recommended limits .\
RESULTS	There was no significant difference in cardiac output between the two groups .\
CONCLUSIONS	High-concentration ( 4 mg in 20 mL of saline ) adrenaline wicks used during FESS significantly improve the quality of the surgical field and decrease blood loss compared to low-concentration ( 1 mg in 20 mL saline ) wicks .\
CONCLUSIONS	Associated hemodynamic changes can be controlled in both groups without significant clinical consequences .\
\
###20451972\
OBJECTIVE	To assess the impact of intraoperative distal vasal flushing during no-scalpel vasectomy on hastening the sperm clearance from the vas deferens and subsequent postvasectomy time to azoospermia .\
METHODS	A total of 906 men undergoing vasectomy at our center from October 2007 to August 2008 were included in this prospective , randomized , controlled study .\
METHODS	Patients were alternately allocated to 1 of 2 groups .\
METHODS	Group A were patients who underwent no scalpel vasectomy alone ; Group B patients , in addition to no scalpel vasectomy , underwent flushing of the distal vasal segment with 30 mL of sterile water .\
METHODS	Postvasectomy semen analysis was done at 4 , 8 , and 12 weeks .\
METHODS	The age , operative time , number of ejaculations , and proportion of patients ' azoospermic at 4 , 8 , and 12 weeks after vasectomy were compared between the 2 groups .\
RESULTS	A total of 727 men were available for final analysis .\
RESULTS	A significantly higher proportion of patients in group B were azoospermic at 4 and 8 weeks when compared with group A ( group B : 53.40 % and 80.68 % ; group A : 33.86 % and 49.6 % at 4 and 8 weeks , respectively ) .\
RESULTS	There was no statistically significant difference in the mean age , operative time , and number of ejaculations between the 2 groups .\
CONCLUSIONS	Distal vasal flushing with 30 mL of sterile water may shorten the time to azoospermia for between 20 % and 30 % of vasectomy patients .\
CONCLUSIONS	Thus , this procedure may be an option for some who choose the vasal flush to avoid the long duration of postvasectomy alternate contraceptive methods .\
\
###23383459\
OBJECTIVE	To observe the effect of acupuncture stimulation of scalp - and body-acupoints on limb function in subacute stroke patients .\
METHODS	A total of 110 stroke inpatients were randomly and equally divided into acupuncture group and control group .\
METHODS	Patients of the acupuncture group were treated by acupuncture stimulation of scalp acupoint Dingnie Qianxiexian ( MS 6 ) and body acupoints Neiguan ( PC 6 ) , Jianyu ( LI 15 ) , Sanyinjiao ( SP 6 ) , etc. once daily for 20 days and routine neurological therapies , including drugs for controlling blood pressure , blood sugar , water-electrolyte balance , anticoagulation , encephaledema reduction , intracranial pressure reduction , anti-inflammation , neurofunction protection , etc. .\
METHODS	The stroke patients of the control group were treated with the routine neurological therapies only .\
METHODS	The Fugl-Meyer assessment ( FMA ) , US National Institutes of Health Stroke Scale ( NIHSS ) were used to assess the patients ' limb function and nerve functional lesion severity before and after the treatment , and the ratio of mortality/disability and recurrence rate were used to assess the efficacy of acupuncture at the end of 3 and 6 months ' follow-up .\
RESULTS	After the treatment , the FMA scores were increased significantly and NIHSS scores decreased considerably in both groups ( P < 0.01 ) , and the effects of acupuncture group were obviously superior to those of the control group ( P < 0.05 ) .\
RESULTS	There were no significant differences between two groups in the ratios of mortality/disability and recurrence rates at the end of 3 and 6 months ' follow-up ( P > 0.05 ) .\
CONCLUSIONS	Scalp acupuncture combined with body acupuncture can evidently improve limb movement function and reduce the nerve function damage in stroke patients .\
\
###19218185\
OBJECTIVE	We evaluated the efficacy of a brief , clinic-based , safer sex program administered by a lay health adviser for young heterosexual African American men newly diagnosed with a sexually transmitted disease ( STD ) .\
METHODS	Subsequent to STD diagnosis , eligible men ( N = 266 ; aged 18-29 years ) were randomized to either a personalized , single-session intervention ( delivered by a lay health adviser ) or standard of care .\
METHODS	We conducted behavioral assessments at baseline and 3 months postintervention ( retention was 74.1 % ) .\
METHODS	We also conducted a 6-month clinic record review .\
RESULTS	Compared to men randomized to the control condition , those receiving the intervention were significantly less likely to acquire subsequent STDs ( 50.4 % vs 31.9 % ; P = .002 ) and more likely to report using condoms during last sexual intercourse ( 72.4 % vs 53.9 % ; P = .008 ) .\
RESULTS	They also reported fewer sexual partners ( mean 2.06 vs 4.15 ; P < .001 ) and fewer acts of unprotected sex ( mean 12.3 vs 29.4 ; P = .045 ) .\
RESULTS	Based on a 9-point rating scale , men in the intervention group had higher proficiency scores for condom application skills ( mean difference = 3.17 ; P < .001 ) .\
CONCLUSIONS	A brief clinic-based intervention delivered by a lay health adviser may be an efficacious strategy to reduce incident STDs among young heterosexual African American men .\
\
###17299808\
OBJECTIVE	To describe the influence of domains of cognition on remission and response of depression in an intervention trial among older primary care patients .\
METHODS	Twenty primary care practices were randomly assigned to Usual Care or to an Intervention consisting of a depression care manager offering algorithm-based care for depression .\
METHODS	In all , 599 adults 60 years and older with a depression diagnosis were included in these analyses .\
METHODS	Depression severity and remission of depression were assessed by the 24-item Hamilton Depression Rating Scale .\
METHODS	The Mini-Mental State Examination ( MMSE ) was our global measure of cognitive function .\
METHODS	Verbal memory was assessed with the memory subscale of the Dementia Rating Scale .\
METHODS	Attention was measured with the digit span from the Weschler Adult Intelligence Test .\
METHODS	Response inhibition , one of the executive functions , was assessed with the Stroop Color-Word test .\
RESULTS	The intervention was associated with improved remission and response rates regardless of cognitive impairment .\
RESULTS	Response inhibition as measured by the Stroop Color-Word test appeared to significantly modify the intervention versus usual care difference in remission and response at 4 months .\
RESULTS	Patients in the poorest performance quartile at baseline on the Stroop Color-Word test in the Intervention Condition were more likely to achieve remission of depression at 4 months than comparable patients in Usual Care [ odds ratio ( OR ) = 17.76 , 95 % Confidence Interval ( CI ) , 3.06 , 103.1 ] .\
CONCLUSIONS	Depressed older adults in primary care with executive dysfunction have low remission and response rates when receiving usual care but benefit from depression care management .\
\
###19249433\
BACKGROUND	Thrombus aspiration devices have been shown to improve reperfusion criteria and to reduce distal embolization in patients treated by percutaneous coronary interventions ( PCI ) in the acute phase of ST-elevation myocardial infarction ( STEMI ) .\
BACKGROUND	There are , however , little data about their efficacy in the reduction of infarct size .\
METHODS	We sought to assess in a prospective randomized trial the impact of thrombus aspiration on infarct size and severity and on left ventricular function in high-risk patients with a first STEMI .\
METHODS	The primary end point was scintigraphic infarct size , and secondary end points were infarct severity and regional and global left ventricular function .\
METHODS	Forty-four patients with completely occluded ( Thrombolysis in Myocardial Infarction flow 0-1 ) proximal segments of infarct-related artery were randomly assigned to thrombus aspiration group with the Export catheter ( n = 20 ) ( Medtronic , Inc , Minneapolis , MN ) or PCI-only group .\
METHODS	A rest Tc-99-mibi gated single-photon emission computed tomographic and contrast-enhanced magnetic resonance imaging were performed 6 + / - 2 days later .\
RESULTS	Infarct size was comparable in patients in the thrombus aspiration group and PCI-only group ( 30.6 % + / - 15.8 % vs 28.5 % + / - 17.9 % of the left ventricle , P = .7 ) as was infarct severity in infarct-related artery territory ( 55 % + / - 12 % vs 55 % + / - 14 % , P = .9 ) .\
RESULTS	Transmurality score as assessed by magnetic resonance imaging was similar in both groups ( 2.03 + / - 1.05 vs 2.16 + / - 1.21 , P = .7 ) .\
RESULTS	There was no impact of thrombus aspiration on other secondary end points .\
CONCLUSIONS	In our study , thrombus aspiration with the Export catheter performed as adjunctive therapy in high-risk patients with total occlusion of the proximal part of major coronary arteries does not decrease infarct size or severity and has no effect on left ventricular regional and global function .\
\
###21871686\
OBJECTIVE	To assess efficacy and safety of saxagliptin added to metformin versus placebo plus metformin in Asian patients with type 2 diabetes mellitus ( T2DM ) and inadequate glycemic control on metformin alone .\
METHODS	Adults ( HbA ( 1c ) 7.0-10 .0 % , on stable metformin 1500 mg/day ) were randomized 1:1 to saxagliptin 5mg daily plus metformin ( n = 283 ) or placebo plus metformin ( n = 287 ) .\
METHODS	The primary end point was HbA ( 1c ) change from baseline to Week 24 .\
RESULTS	Saxagliptin plus metformin provided significant adjusted mean decreases versus placebo plus metformin ( p 0.0052 ) in HbA ( 1c ) ( -0.78 % versus -0.37 % ) , fasting plasma glucose ( -1.14 mmol/L versus -0.58 mmol/L ) , and postprandial glucose area under the curve from 0 to 180 min ( -315 mmol min/L versus -160 mmol min/L ) .\
RESULTS	Significantly more saxagliptin-treated patients achieved a therapeutic glycemic response ( HbA ( 1c ) < 7.0 % ) ( 46.5 % versus 30.5 % ; p = 0.0001 ) .\
RESULTS	The proportion of patients experiencing adverse events ( excluding hypoglycemia ) was similar for saxagliptin plus metformin ( 42.8 % ) versus placebo plus metformin ( 40.8 % ) .\
RESULTS	Hypoglycemic events were reported in 1.4 % of patients in each group .\
CONCLUSIONS	Saxagliptin added to metformin significantly improved glycemic control and was well tolerated in Asian patients with T2DM who had inadequate glycemic control with metformin and diet and lifestyle modification .\
\
###19875426\
OBJECTIVE	To test the effectiveness of a complex intervention designed , within a theoretical framework , to improve outcomes for patients with coronary heart disease .\
METHODS	Cluster randomised controlled multicentre trial .\
METHODS	General practices in Northern Ireland and the Republic of Ireland , regions with different healthcare systems .\
METHODS	903 patients with established coronary heart disease registered with one of 48 practices .\
METHODS	Tailored care plans for practices ( practice based training in prescribing and behaviour change , administrative support , quarterly newsletter ) , and tailored care plans for patients ( motivational interviewing , goal identification , and target setting for lifestyle change ) with reviews every four months at the practices .\
METHODS	Control practices provided usual care .\
METHODS	The proportion of patients at 18 month follow-up above target levels for blood pressure and total cholesterol concentration , and those admitted to hospital , and changes in physical and mental health status ( SF-12 ) .\
RESULTS	At baseline the numbers ( proportions ) of patients above the recommended limits were : systolic blood pressure greater than 140 mm Hg ( 305/899 ; 33.9 % , 95 % confidence interval 30.8 % to 33.9 % ) , diastolic blood pressure greater than 90 mm Hg ( 111/901 ; 12.3 % , 10.2 % to 14.5 % ) , and total cholesterol concentration greater than 5 mmol/l ( 188/860 ; 20.8 % , 19.1 % to 24.6 % ) .\
RESULTS	At the 18 month follow-up there were no significant differences between intervention and control groups in the numbers ( proportions ) of patients above the recommended limits : systolic blood pressure , intervention 98/360 ( 27.2 % ) v control , 133/405 ( 32.8 % ) , odds ratio 1.51 ( 95 % confidence interval 0.99 to 2.30 ; P = 0.06 ) ; diastolic blood pressure , intervention 32/360 ( 8.9 % ) v control , 40/405 ( 9.9 % ) , 1.40 ( 0.75 to 2.64 ; P = 0.29 ) ; and total cholesterol concentration , intervention 52/342 ( 15.2 % ) v control , 64/391 ( 16.4 % ) , 1.13 ( 0.63 to 2.03 ; P = 0.65 ) .\
RESULTS	The number of patients admitted to hospital over the 18 month study period significantly decreased in the intervention group compared with the control group : 107/415 ( 25.8 % ) v 148/435 ( 34.0 % ) , 1.56 ( 1.53 to 2.60 ; P = 0.03 ) .\
CONCLUSIONS	Admissions to hospital were significantly reduced after an intensive 18 month intervention to improve outcomes for patients with coronary heart disease , but no other clinical benefits were shown , possibly because of a ceiling effect related to improved management of the disease .\
BACKGROUND	Current Controlled Trials ISRCTN24081411 .\
\
###16697124\
BACKGROUND	This trial evaluated the efficacy of amantadine , propranolol and their combination in cocaine dependent patients with severe cocaine withdrawal symptoms .\
METHODS	Cocaine withdrawal symptom severity was measured by the cocaine selective severity assessment ( CSSA ) .\
METHODS	One hundred and ninety-nine patients with high scores on the CSSA participated in a 10-week double-blind trial .\
METHODS	Patients were randomly assigned to receive amantadine ( 300 mg/day ) , propranolol ( 100mg/day ) , a combination of amantadine ( 300 mg/day ) and propranolol ( 100mg/day ) or matching placebo capsules .\
METHODS	The primary outcome measure was cocaine abstinence .\
RESULTS	In the intent-to-treat sample , there were no significant differences between the four medication groups in treatment retention .\
RESULTS	The odds of cocaine abstinence showed a marginally significant increase over time in the propranolol group ( p = 0.06 ) but not in the other three groups .\
RESULTS	In highly medication-adherent patients , treatment retention was significantly better in the propranolol group compared to the placebo group ( p = 0.01 ) and the odds of cocaine abstinence increased significantly over time in the propranolol group but not in the other three groups .\
CONCLUSIONS	In the intent-to-treat sample , none of the three active treatments ( propranolol , amantadine or their combination ) was significantly more effective than placebo in promoting abstinence from cocaine among patients who entered treatment with more severe cocaine withdrawal symptoms .\
CONCLUSIONS	Among patients highly adherent to study medication , propranolol treatment was associated with better treatment retention and higher rates of cocaine abstinence compared to placebo .\
\
###8102538\
OBJECTIVE	To assess the effect of an elective abdominal surgical operation ( open cholecystectomy ) on the rate of protein synthesis in skeletal muscle in humans .\
METHODS	Prospective random control trial .\
METHODS	University hospital .\
METHODS	17 Metabolically healthy patients who were to undergo elective open cholecystectomy .\
METHODS	Patients randomised to receive either saline alone ( n = 8 ) or total parenteral nutrition ( n = 9 ) for three days after operation .\
METHODS	The rate of protein synthesis in muscle was calculated from the increase in enrichment of ( 1-13C ) leucine in protein after a flooding dose of ( 1-13C ) leucine .\
RESULTS	Median ( quartiles ) rate of protein synthesis had decreased on the third postoperative day in the saline group by 49 % ( from 2.42 [ 2.03 , 2.54 ] to 1.24 [ 0.99 , 1.63 ] ) and in the group that had received total parenteral nutrition by 54 % ( from 1.96 [ 1.90 , 2.07 ] to 0.91 [ 0.79 , 1.06 ] ) ( p < 0.01 ) .\
CONCLUSIONS	The trauma associated with open cholecystectomy reduced the rate of protein synthesis in skeletal muscle by half in three days , and conventional total parenteral nutrition had no effect on these changes .\
\
###7889440\
OBJECTIVE	To determine whether acetylsalicylic acid ( ASA ) inhibits hemostasis and platelet function in some individuals ( ASA responders ) but not in others ( ASA nonresponders ) .\
METHODS	In this two-part study , part 1 was a randomized , double-blind crossover study of the effects of various single doses of ASA ( 80 to 1300 mg ) on primary hemostasis and platelet function .\
METHODS	Part 2 was a prospective cohort study of the effects of a chronic dose of ASA ( 325 mg ) on primary hemostasis and platelet function .\
METHODS	A hospital research laboratory and a cardiac care ward .\
METHODS	Part 1 : 10 healthy volunteers ( five male , five female ) .\
METHODS	Part 2 : 40 consecutive patients undergoing elective coronary artery bypass grafting ( CABG ) .\
RESULTS	Part 1 : ASA , in a dose-related manner , prolonged the bleeding time in 60 % of volunteers ( ASA responders ) , which was associated with decreases in platelet thromboxane ( Tx ) A2 and 12-hydroxyeicosatetraenoic acid ( 12-HETE ) synthesis and in platelet aggregation and adhesion .\
RESULTS	However , in volunteers whose bleeding time was not prolonged ( ASA nonresponders ) , platelet 12-HETE synthesis and platelet adhesion were unchanged or increased ( P < 0.001 ) , despite platelet TxA2 and platelet aggregation being inhibited .\
RESULTS	Part 2 : similarly , 58 % of the CABG patients were ASA responders and all of their platelet biochemistry and function tests were inhibited , while in the CABG patient ASA nonresponders ( no prolongation of bleeding time ) , platelet 12-HETE and platelet adhesion were increased ( P < 0.001 ) .\
\
###16614691\
OBJECTIVE	The process of inflammation is crucial in migraine , and several nonsteroidal anti-inflammatory drugs ( NSAIDs ) are effective in the treatment of migraine attacks .\
OBJECTIVE	Despite their efficacy , the routine use of NSAIDs is limited by side effects as well as incomplete efficacy in some patients .\
OBJECTIVE	Among the available options , lysine clonixinate ( LC ) and naproxen sodium ( NS ) have proved effective in migraine .\
OBJECTIVE	The aim of this study was to compare the efficacy and tolerability of oral formulations of LC and NS in the treatment of moderate or severe migraine attacks , with a double-blind , crossover design .\
METHODS	Seventy subjects ( 62 women , 8 men ) between ages 18 and 71 years ( mean age , 41 ) with migraine according to the criteria of the International Headache Society were prospectively enrolled .\
METHODS	The patients were randomized into 2 groups and each participant treated 2 migraine attacks .\
METHODS	Group 1 treated the first attack with LC and the second attack with NS .\
METHODS	Group 2 treated 2 attacks in a counterbalanced order .\
METHODS	Doses were 250 mg of LC or 550 mg of NS , which were encapsulated for equal appearance .\
METHODS	Headache intensity , nausea , photophobia , and side effects were evaluated at baseline , 1 hour , and 2 hours after drug administration .\
METHODS	Rescue drugs were allowed after 2 hours for those who did n't respond , and this was also compared between groups .\
RESULTS	Sixty patients ( 54 women , 6 men ) completed the study .\
RESULTS	At 1 hour , 13.6 % patients who used LC were pain-free compared with 11.9 % who used NS ( P = .78 ) .\
RESULTS	At 2 hours , 35.6 % patients who took LC and 32.2 % who took NS were pain-free ( P = .69 ) .\
RESULTS	At baseline , 52.5 % of the patients randomized to group 1 reported nausea , compared with 33.9 % in group 2 , and both drugs eliminated nausea : At both 1 hour and 2 hours , nausea diminished significantly for those taking LC , but only after 2 hours for those who took NS ( P < .0001 ) .\
RESULTS	Both drugs eliminated photophobia at 1 hour and 2 hours ; however , LC was superior to NS in reducing photophobia at 2 hours ( P = .027 ) .\
RESULTS	Ten patients who took LC and 8 who took NS required rescue drugs after 2 hours .\
RESULTS	Twelve patients who used LC and 16 who took NS reported side effects .\
CONCLUSIONS	Although this study did not include a placebo arm , which impairs any definitive efficacy claims , we found LC and NS to be similarly effective and well tolerated in patients presenting moderate or severe attacks of migraine .\
\
###8853584\
BACKGROUND	The purpose of this study was to elucidate whether the reduction of mortality with amiodarone after myocardial infarction depended on ejection fraction .\
METHODS	The data from the Polish Amiodarone Trial were analysed retrospectively .\
METHODS	Patients with acute myocardial infarction and contraindications to beta-blockers were randomized on days 5-7 after admission to receive amiodarone ( n = 305 ) or placebo ( n = 308 ) .\
METHODS	Short and long-term ( 46 months ) mortality were analysed comparing the groups with impaired ( ejection fraction < 40 % ) and preserved ( ejection fraction > or = 40 % ) left ventricular function .\
METHODS	A subset of patients ( n = 523 ) with available echocardiograms were subjected to this analysis .\
RESULTS	Long-term and sudden cardiac mortality were significantly reduced with amiodarone in the group of patients with ejection fraction > or = 40 % ( amiodarone versus placebo , respectively : 9.1 versus 16.5 % , P < 0.05 ; 3.4 versus 8.2 , P < 0.05 ) .\
RESULTS	No beneficial effect of amiodarone was observed in the group with low ejection fraction ( cardiac and sudden cardiac mortality : amiodarone versus placebo , 20.8 versus 19.3 % and 7.8 versus 5.7 % respectively ) .\
RESULTS	One-year mortality also revealed a favourable trend only in amiodarone-allocated patients with ejection fraction > or = 40 % .\
CONCLUSIONS	Amiodarone decreased long-term and sudden cardiac mortality after myocardial infarction only in patients with preserved left ventricular function .\
CONCLUSIONS	No benefit was observed in patients with decreased ejection fraction .\
\
###19724191\
OBJECTIVE	To assess pharmacokinetics , safety and efficacy of darunavir/ritonavir ( DRV/r ) and optimized background regimen in treatment-experienced patients ( 6-17 years ) .\
METHODS	Forty-eight-week , open-label , two-part , phase II study .\
METHODS	In part I , 44 patients were randomized ( 1 : 1 ratio ) to receive a body weight-adjusted , adult-equivalent dose ( group A ) or a 20-33 % higher DRV/r twice daily ( b.i.d. ) dose ( group B ) .\
METHODS	Pharmacokinetics , safety and efficacy were assessed following 2-week dosing ( part I ) , which determined dosing for part II ( evaluated 48-week safety and efficacy ) .\
RESULTS	In part I , both groups met the protocol-specified criteria for pharmacokinetics and showed favorable tolerability and efficacy .\
RESULTS	The following body-weight doses were selected : DRV/r 375/50 mg b.i.d. ( 20 - < 30 kg ) , 450/60 mg b.i.d. ( 30 - < 40 kg ) and 600/100 mg b.i.d. ( > or = 40 kg ) ; these gave an AUC24h , C0h and Cmax of 102 , 114 and 112 % , respectively , versus the corresponding mean adult pharmacokinetic parameter .\
RESULTS	In part II , 80 patients received DRV/r ( median age : 14 years , mean baseline HIV-1 RNA : 4.64 log ( 10 ) copies/ml ) .\
RESULTS	One patient ( 1 % ) discontinued ( treatment-unrelated grade 3 anxiety ) .\
RESULTS	An abnormal mean baseline triglyceride level was normalized at 48 weeks ( P < 0.01 ) .\
RESULTS	At week 48 , 65 % had at least 1.0 log ( 10 ) HIV-1 RNA reduction ; 59 and 48 % achieved HIV-1 RNA less than 400 and less than 50 copies/ml , respectively ( time-to-loss-of-virologic response ) .\
RESULTS	Mean age-adjusted weight z-score increased by 0.2 ( P = 0.003 ) .\
CONCLUSIONS	In treatment-experienced children and adolescents , DRV/r showed comparable exposure to adults with appropriate dose selection , favorable safety and tolerability , improved body weight and significant virologic response .\
CONCLUSIONS	DRV/r is a valuable therapeutic option for this population .\
\
###15273929\
BACKGROUND	Evaluation of patient satisfaction with the perioperative care is an integral part of modern quality management .\
BACKGROUND	For this purpose simple questioning techniques are often used in clinical practise or reports of clinical trials .\
BACKGROUND	However , little research has been performed to investigate whether these tools and methods are useful and provide valid information .\
METHODS	Two-hundred patients undergoing elective surgical procedures were interviewed .\
METHODS	Five different simple techniques or questions that have been used in the international and in the German literature throughout the last years were applied in random sequence together with the validated German translation of the QoR-9 questionnaire to measure quality of recovery .\
METHODS	All analyses were performed descriptively .\
RESULTS	All investigated techniques could be answered without help by another person in 95 % up to 100 % .\
RESULTS	All simple dichotomous questions regarding satisfaction were insufficient to discriminate satisfied from less satisfied patients .\
RESULTS	A rating using grades known from the German school system ( 1 - 6 ) and a visual analogue scale ( VAS ; 0 - 100 mm ) obtained ratings lower than the maximum possible values in 10 % and 11 % of the patients respectively .\
RESULTS	Furthermore , the flexibility that was provided by these tools was not utilized by the patients .\
RESULTS	The results of the QoR-9 questionnaire as a marker of postoperative recovery showed only a moderate correlation with ratings of patient satisfaction .\
CONCLUSIONS	Until now , there is no method or questioning technique in the German language that can be recommended for a quality assurance program .\
CONCLUSIONS	Thus , further research is needed to develop tools that provide valid information with adequate resolution to allow discrimination of patient satisfaction with perioperative care .\
\
###25066329\
BACKGROUND	Evidence is weak for the ability of long-term non-invasive positive pressure ventilation ( NPPV ) to improve survival in patients with stable hypercapnic chronic obstructive pulmonary disease ( COPD ) .\
BACKGROUND	Previous prospective studies did not target a reduction in hypercapnia when adjusting ventilator settings .\
BACKGROUND	This study investigated the effect of long-term NPPV , targeted to markedly reduce hypercapnia , on survival in patients with advanced , stable hypercapnic COPD .\
METHODS	This investigator-initiated , prospective , multicentre , randomised , controlled clinical trial enrolled patients with stable GOLD stage IV COPD and a partial carbon dioxide pressure ( PaCO2 ) of 7 kPa ( 51.9 mm Hg ) or higher and pH higher than 7.35 .\
METHODS	NPPV was targeted to reduce baseline PaCO2 by at least 20 % or to achieve PaCO2 values lower than 6.5 kPa ( 48.1 mm Hg ) .\
METHODS	Patients were randomly assigned ( in a 1:1 ratio ) via a computer-generated randomisation sequence with a block size of four , to continue optimised standard treatment ( control group ) or to receive additional NPPV for at least 12 months ( intervention group ) .\
METHODS	The primary outcome was 1-year all-cause mortality .\
METHODS	Analysis was by intention to treat .\
METHODS	The intervention was unblinded , but outcome assessment was blinded to treatment assignment .\
METHODS	This study is registered with ClinicalTrials.gov , number NCT00710541 .\
RESULTS	Patients were recruited from 36 respiratory units in Germany and Austria , starting on Oct 29 , 2004 , and terminated with a record of the vital status on July 31 , 2011.195 patients were randomly assigned to the NPPV group ( n = 102 ) or to the control group ( n = 93 ) .\
RESULTS	All patients from the control group and the NPPV group were included in the primary analysis .\
RESULTS	1-year mortality was 12 % ( 12 of 102 patients ) in the intervention group and 33 % ( 31 of 93 patients ) in the control group ; hazard ratio 0.24 ( 95 % CI 0.11-0 .49 ; p = 0.0004 ) .\
RESULTS	14 ( 14 % ) patients reported facial skin rash , which could be managed by changing the type of the mask .\
RESULTS	No other intervention-related adverse events were reported .\
CONCLUSIONS	The addition of long-term NPPV to standard treatment improves survival of patients with hypercapnic , stable COPD when NPPV is targeted to greatly reduce hypercapnia .\
BACKGROUND	German Lung Foundation ; ResMed , Germany ; Tyco Healthcare , Germany ; and Weinmann , Germany .\
\
###12377965\
OBJECTIVE	To identify the optimal schedule for infusion of cytarabine ( ara-C ) given with cladribine ( 2-CdA ) to pediatric patients with acute myeloid leukemia ( AML ) , and to compare the effects of the two schedules on the pharmacokinetics of ara-C triphosphate ( ara-CTP ) in leukemic cells .\
METHODS	Forty-nine pediatric patients with newly diagnosed primary AML received a 5-day course of ara-C 500 mg/m ( 2 ) / d and 2-CdA 9 mg/m ( 2 ) / d.\
METHODS	They were randomly assigned to receive ara-C as either a 2-hour daily infusion ( arm A ) or a continuous infusion ( arm B ) .\
METHODS	Cellular pharmacokinetics were studied on days 1 and 2 .\
METHODS	All patients then received two courses of remission induction chemotherapy with daunorubicin , ara-C , and etoposide ( DAV ) .\
RESULTS	Thirty-two percent of patients ( seven of 22 ) in arm A and 63 % ( 17 of 27 ) in arm B entered complete remission ( P = .045 ) after ara-C and 2-CdA therapy .\
RESULTS	Coadministration of 2-CdA increased the intracellular concentration of ara-CTP in 20 of 36 patients , although we found no statistically significant difference between the treatment arms in this effect ( P = .63 ) .\
RESULTS	The incidence of toxicity did not differ significantly between the two treatment arms ( P = .53 ) .\
RESULTS	After two courses of DAV , the rate of complete remission was 91 % in arm A and 96 % in arm B ( P = .58 ) .\
CONCLUSIONS	Intracellular accumulation of ara-CTP is increased when 2-CdA is given with ara-C , but no schedule-dependent differences in this effect were seen .\
CONCLUSIONS	The combination of 2-CdA and ara-C seems to be effective therapy for pediatric AML .\
\
###11885186\
BACKGROUND	Over the years , the definition of implant failure has varied , with some investigators accounting for all implants placed , while others discard failures that occurred before clinical loading .\
BACKGROUND	The influence of stresses transmitted to various bone densities , by different prosthetic appliances as well as the method used to determine failures , needs to be clearly understood .\
BACKGROUND	This paper reports on the influence of two different methods of determining 36-month survival of implants used to support different dental prostheses .\
METHODS	More than 2,900 implants with six different designs were placed in 829 patients at 32 study centers and followed for 3 years .\
METHODS	The first method of determining survival accounted for all failures from placement through 36 months , while the second method counted only failures from post-loading of the prosthesis to 36 months .\
METHODS	Survival curves were used to determine differences in survival outcomes for the two methods .\
RESULTS	For the maxillary single-tooth prosthetic application , implant survival from placement to 36 months was 94.7 % when all failures were counted and increased to 98.3 % with the post-loading method .\
RESULTS	For upper completely edentulous applications , implant survival was 85.3 % with all failures counted and 95.6 % with the post-loading method .\
RESULTS	This 10.3 % difference is clinically important .\
RESULTS	The survival for implants in lower completely edentulous applications increased by 4.4 % simply by using the post-loading approach .\
RESULTS	Implants used for upper posterior , partially edentulous applications involved only hydroxyapatite ( HA ) - coated implants , and the survival rates were similar ( 96.4 % for all implants and 98.2 % for the post-loading method ) .\
RESULTS	The difference in reported survival rates for implants in the lower posterior , partially edentulous application was 5.8 % .\
RESULTS	Since failures tended to occur in the earlier phases of treatment , the post-loading approach always resulted in more favorable survival data .\
RESULTS	With the post-loading approach , valuable information related to implant performance before loading is lost .\
RESULTS	In all comparisons , HA-coated implant survival was always better than non-HA implants .\
RESULTS	Clinical investigators should clearly state the method used for determining failures .\
RESULTS	For all implants included in the study , survival curves illustrated different failure patterns for each method of determining overall survival .\
CONCLUSIONS	Reporting of implant survival rates based on the post-loading method provides more favorable survival rates ; however , accounting for all implants provides a more accurate method of determining survival .\
\
###18381181\
BACKGROUND	The effects of chronic inhibition of 5 ' - phosphodiesterase with sildenafil on functional capacity , ventilatory efficiency , oxygen uptake , pulmonary hypertension , and endothelial function in chronic heart failure ( CHF ) are unknown .\
METHODS	We conducted a randomized , double-blind , placebo-controlled trial to assess the acute ( 1 hour after 50 mg by mouth ) and chronic ( 4 weeks after 50 mg 3 times per day by mouth ) effects of sildenafil in outpatients with CHF .\
METHODS	The outcomes were cardiopulmonary exercise test parameters ( chronic effect ) , echocardiographic-derived pulmonary artery systolic pressure , and plethysmography-derived forearm blood flow ( acute and chronic effects ) .\
RESULTS	Nineteen patients with CHF ( 48 + / - 12 years ) with an ejection fraction of 28 % + / - 6 % were studied .\
RESULTS	Patients who received sildenafil ( n = 11 ) showed improved maximal oxygen uptake , ventilatory efficiency , and oxygen uptake kinetics .\
RESULTS	Sildenafil decreased pulmonary artery systolic pressure levels at 60 minutes and at 4 weeks compared with changes after placebo ( P = .004 for group and time interaction ) .\
RESULTS	Improvement in ventilatory efficiency was positively associated with reductions in pulmonary artery systolic pressure .\
RESULTS	Patients allocated to placebo demonstrated a trend toward decreased forearm blood flow after reactive hyperemia , whereas this remained unchanged in patients allocated to sildenafil .\
CONCLUSIONS	Sildenafil administration for 4 weeks in stable outpatients with CHF improves functional capacity , ventilatory efficiency , oxygen uptake kinetics , and pulmonary hypertension .\
CONCLUSIONS	These effects may be mediated in part by improvements in endothelial function .\
\
###17237736\
OBJECTIVE	To examine and compare young sex workers ' risk of acquisition of sexually transmitted infections ( STIs ) with the risk among their older counterparts .\
OBJECTIVE	To evaluate the effect of young age -- 16-19 years vs. 20 years and older -- on risk of incident infection with Neisseria gonorrhoeae ( GC ) or Chlamydia trachomatis ( CT ) .\
METHODS	A randomized controlled trial of 1,000 sex workers in Madagascar was conducted .\
METHODS	STI testing was conducted at baseline , 6 , 12 , and 18 months .\
RESULTS	About 13 % of the cohort ( n = 134 ) was composed of young women aged 16-19 years .\
RESULTS	STI incidence rates in this group over the 18-month study period were high : 51.9 / 100 woman-years ( WY ) for GC and 47.4 / 100 WY for CT compared to 27.4 / 100 WY and 19.1 / 100 WY for sex workers over age 20 , respectively .\
RESULTS	In multivariable models , young sex workers were at significantly higher STI risk compared with their older peers : The adjusted risk ratio ( aRR ) for GC comparing younger to older women was 1.50 ( 95 % confidence interval ( CI ) : 1.20 , 1.88 ) ; for CT , the aRR was 1.72 ( 95 % CI : 1.35 , 2.19 ) and for GC or CT combined , the aRR was 1.42 ( 95 % CI : 1.22 , 1.66 ) .\
CONCLUSIONS	This exploratory analysis suggests that additional research is warranted to identify effective and acceptable prevention strategies that benefit young women , and interventions already proven effective among adolescents should be given high priority for scale-up .\
\
###18851855\
OBJECTIVE	To evaluate the effect of N-acetyl cysteine ( NAC ) on gestational age at delivery in women with previous preterm labor and bacterial vaginosis .\
METHODS	A randomized , double-blind , placebo-controlled trial with 280 women between 16 and 18 weeks of pregnancy who had 1 previous preterm birth and had just been successfully treated for bacterial vaginosis with metronidazole for 1 week .\
METHODS	The women were randomized to receive 0.6 g of NAC per day plus 17-hydroxyprogesterone caproate ( 17-OHPC ) or placebo plus 17-OHPC until 36 completed weeks of pregnancy or active labor .\
METHODS	A vaginal swab was taken during labor .\
RESULTS	Reaching 36 weeks of pregnancy was more frequent ( P < 0.05 ) and gestational age at delivery was significantly higher in the NAC than in the placebo group ( 37.4 weeks + / -0.4 weeks vs 34.1 weeks + / -1.2 weeks , P < 0.05 ) .\
RESULTS	The discontinuation rate was 11.4 % in the NAC group .\
CONCLUSIONS	Oral NAC was found to reduce the recurrence of preterm birth in patients with bacterial vaginosis .\
\
###24927275\
OBJECTIVE	To study the influence of acupuncture at Waiguan ( TE5 ) on the functional connectivity of the central nervous system of patients with ischemic stroke .\
METHODS	Twenty-four patients with ischemic stroke in the left basal ganglia were randomized based on gender to receive TE5 acupuncture ( n = 12 ) or nonacupoint acupuncture ( n = 12 ) .\
METHODS	Each group underwent sham acupuncture and then verum acupuncture while being scanned with functional magnetic resonance imaging .\
METHODS	Six regions of interest ( ROI ) were defined , including bilateral motor , somatosensory , and bilateral basal ganglia areas .\
METHODS	The functional connectivity between these ROIs and all voxels of the brain was analyzed in Analysis of Functional NeuroImages ( AFNI ) to explore the differences between verum acupuncture and sham acupuncture at TE5 and between TE5 acupuncture and nonacupoint acupuncture .\
METHODS	The participants were blinded to the allocation .\
RESULTS	The effect of acupuncture on six seed-associated networks was explored .\
RESULTS	The result demonstrated that acupuncture at Waiguan ( TE5 ) can regulate the sensorimotor network of the ipsilesional hemisphere , stimulate the contralesional sensorimotor network , increase cooperation of bilateral sensorimotor networks , and change the synchronization between the cerebellum and cerebrum .\
RESULTS	Furthermore , a lot of differences of effect existed between verum acupuncture and sham acupuncture at TE5 , but there was little difference between TE5 acupuncture and nonacupoint acupuncture .\
CONCLUSIONS	The modulation of synchronizations between different regions within different brain networks might be the mechanism of acupuncture at Waiguan ( TE5 ) .\
CONCLUSIONS	Stimulation of the contralesional sensorimotor network and increase of cooperation of bilateral hemispheres imply a compensatory effect of the intact hemisphere , whereas changes in synchronization might influence the sensorimotor function of the affected side of the body .\
BACKGROUND	Chinese Clinical Trial Registry ChiCTR-ONRC-08000255 .\
\
###12614996\
BACKGROUND	Prior reports of decreased levels of essential fatty acids among schizophrenic patients have generated several hypotheses proposing inherent abnormalities in phospholipid and fatty acid metabolism and have provided the basis for treatment trials ; however , these essential fatty acid aberrations may be attributable to uncontrolled factors , such as smoking , rather than abnormalities inherent to schizophrenia .\
METHODS	Erythrocyte fatty acid compositions were quantified in 72 medicated schizophrenic or schizoaffective patients both at baseline and after 16 weeks of supplementation with 3 g/day of either ethyl-eicosapentaenoic acid or placebo .\
METHODS	Current smoking status , gender , dietary survey , and Montgomery Asburg Depression Rating Scale , Repeatable Battery for the Assessment of Neuropsychological Status , Abnormal Involuntary Movement Scale , and Positive and Negative Syndrome Scale scores were assessed .\
RESULTS	Schizophrenic patients who smoked had lower baseline erythrocyte docosahexaenoic acid percent ( 2.98 + / -.7 vs. 3.59 + / - 1.2 , p < .005 ) and eicosapentaenoic acid ( EPA ) percent ( .39 + / -.13 vs. 47 + / -.22 , p < .05 ) , compared with nonsmokers , with a significant gender interaction ( p < .01 ) in multivariate analyses of variance .\
RESULTS	Baseline arachidonic acid did not differ .\
RESULTS	Smokers reported lower dietary intake ( percent total fat ) of linolenic acid ( F = 10.1 , p < .003 ) compared with nonsmokers .\
RESULTS	Nonsmoking women reported greater dietary intake of EPA compared with smoking men or nonsmokers of either gender .\
CONCLUSIONS	Smoking status , gender , and dietary intake significantly predicted erythrocyte polyunsaturated fatty acid status among schizophrenic patients .\
CONCLUSIONS	No evidence was found for subgroups of schizophrenia or relationships to specific symptom severity on the basis of erythrocyte fatty acids .\
CONCLUSIONS	Prior reports of abnormalities of essential fatty acid metabolism among schizophrenic patients may have been an artifact of patients ' smoking behavior and differences in dietary intake of omega-3 fatty acids .\
\
###17135584\
BACKGROUND	No pharmacologic therapy has conclusively proved to be effective for the treatment of nonalcoholic steatohepatitis , which is characterized by insulin resistance , steatosis , and necroinflammation with or without centrilobular fibrosis .\
BACKGROUND	Pioglitazone is a thiazolidinedione that ameliorates insulin resistance and improves glucose and lipid metabolism in type 2 diabetes mellitus .\
METHODS	We randomly assigned 55 patients with impaired glucose tolerance or type 2 diabetes and liver biopsy-confirmed nonalcoholic steatohepatitis to 6 months of treatment with a hypocaloric diet ( a reduction of 500 kcal per day in relation to the calculated daily intake required to maintain body weight ) plus pioglitazone ( 45 mg daily ) or a hypocaloric diet plus placebo .\
METHODS	Before and after treatment , we assessed hepatic histologic features , hepatic fat content by means of magnetic resonance spectroscopy , and glucose turnover during an oral glucose tolerance test ( [ 14C ] glucose given with the oral glucose load and [ 3H ] glucose given by intravenous infusion ) .\
RESULTS	Diet plus pioglitazone , as compared with diet plus placebo , improved glycemic control and glucose tolerance ( P < 0.001 ) , normalized liver aminotransferase levels as it decreased plasma aspartate aminotransferase levels ( by 40 % vs. 21 % , P = 0.04 ) , decreased alanine aminotransferase levels ( by 58 % vs. 34 % , P < 0.001 ) , decreased hepatic fat content ( by 54 % vs. 0 % , P < 0.001 ) , and increased hepatic insulin sensitivity ( by 48 % vs. 14 % , P = 0.008 ) .\
RESULTS	Administration of pioglitazone , as compared with placebo , was associated with improvement in histologic findings with regard to steatosis ( P = 0.003 ) , ballooning necrosis ( P = 0.02 ) , and inflammation ( P = 0.008 ) .\
RESULTS	Subjects in the pioglitazone group had a greater reduction in necroinflammation ( 85 % vs. 38 % , P = 0.001 ) , but the reduction in fibrosis did not differ significantly from that in the placebo group ( P = 0.08 ) .\
RESULTS	Fatigue and mild lower-extremity edema developed in one subject who received pioglitazone ; no other adverse events were observed .\
CONCLUSIONS	In this proof-of-concept study , the administration of pioglitazone led to metabolic and histologic improvement in subjects with nonalcoholic steatohepatitis .\
CONCLUSIONS	Larger controlled trials of longer duration are warranted to assess the long-term clinical benefit of pioglitazone .\
CONCLUSIONS	( ClinicalTrials.gov number , NCT00227110 [ ClinicalTrials.gov ] . )\
\
###19503030\
OBJECTIVE	To compare image quality and radiation exposure from pediatric thoracic spine radiographs from two systems , one using a granular structure scintillator and another using a needle structure scintillator with 40 % reduction of exposure .\
METHODS	Randomized prospective study of 296 patients divided into 2 groups of 5 weight categories from 4 to 60 kg .\
METHODS	Standard technique parameters are used for granular structure scintillators with dose reduction of 40 % applied for needle structure scintillators based on results from a phantom study .\
METHODS	Image quality based on detectability of 8 anatomical structures for both types of scintillators was assessed by 6 blinded radiologists .\
METHODS	Exposure was expressed by DLP .\
METHODS	Results underwent statistical analysis .\
RESULTS	Overall , image quality was superior with corresponding dose reduction between 33-46 % according to weight with needle structure scintillators .\
RESULTS	For the 4 lower weight categories , image quality was identical .\
CONCLUSIONS	With image quality at least equal , new needle structure scintillator units allow a dose reduction of about 40 % .\
\
###24771618\
OBJECTIVE	Weight losses in lifestyle interventions are variable , yet prediction of long-term success is difficult .\
OBJECTIVE	The utility of using various weight loss thresholds in the first 2 months of treatment for predicting 1-year outcomes was examined .\
METHODS	Participants included 2327 adults with type 2 diabetes ( BMI :35.86.0 ) randomized to the intensive lifestyle intervention ( ILI ) of the Look AHEAD trial .\
METHODS	ILI included weekly behavioral sessions designed to increase physical activity and reduce caloric intake .\
METHODS	1-month , 2-month , and 1-year weight changes were calculated .\
RESULTS	Participants failing to achieve a 2 % weight loss at Month 1 were 5.6 ( 95 % CI :4.5 , 7.0 ) times more likely to also not achieve a 10 % weight loss at Year 1 , compared to those losing 2 % initially .\
RESULTS	These odds were increased to 11.6 ( 95 % CI :8.6 , 15.6 ) when using a 3 % weight loss threshold at Month 2 .\
RESULTS	Only 15.2 % and 8.2 % of individuals failing to achieve the 2 % and 3 % thresholds at Months 1 and 2 , respectively , go on to achieve a 10 % weight loss at Year 1 .\
CONCLUSIONS	Given the association between initial and 1-year weight loss , the first few months of treatment may be an opportune time to identify those who are unsuccessful and utilize rescue efforts .\
BACKGROUND	clinicaltrials.gov Identifier : NCT00017953 .\
\
###17043094\
BACKGROUND	Gemcitabine and paclitaxel ( Taxol ) each provides an efficacious non-platinum option for the treatment of advanced non-small-cell lung cancer ( NSCLC ) , but the optimal dosage and schedule of the two agents used in combination are not well defined .\
METHODS	Previously untreated patients with advanced NSCLC were randomized to receive gemcitabine-paclitaxel on a traditional three-weekly schedule ( Arm A ) or a novel weekly schedule ( Arm B ) as follows-Arm A ( three-weekly ) : gemcitabine 1000 mg/m2 infused > 30 min on days 1 and 8 and paclitaxel 200 mg/m2 infused > 3 h on day 1 of a 21-day cycle or Arm B ( weekly ) : gemcitabine 1000 mg/m2 infused > 30 min and paclitaxel 100 mg/m2 infused > 1 h , both administered on days 1 and 8 of a 21-day cycle .\
RESULTS	One hundred patients received at least one dose of treatment .\
RESULTS	The weekly schedule , Arm B , was more efficacious and less hematologically toxic than Arm A. Confirmed complete and partial response rates were 28.2 % and 26.8 % , respectively .\
RESULTS	Median survival was 10.3 months on Arm B and 7.9 months on Arm A ( log-rank P = 0.10 ) ; 1 - and 2-year survival rates also favor Arm B : 42.0 % versus 34.0 % and 18.0 % versus 6.0 % .\
RESULTS	Progression-free survival was 5.8 versus 4.8 months , again favoring Arm B ( log-rank P = 0.06 ) .\
RESULTS	There was a two-fold lower frequency of grade 3/4 hematologic events with Arm B as follows : neutropenia ( 16 % versus 30 % ) , thrombocytopenia ( 4 % versus 8 % ) , and anemia ( 2 % versus 6 % ) .\
RESULTS	One patient ( 2 % ) in each treatment group developed febrile neutropenia .\
CONCLUSIONS	In this trial , both schedules were efficacious and tolerable , although the weekly schedule resulted in improved survival and lower hematologic toxicity compared with a three-weekly schedule .\
CONCLUSIONS	The weekly schedule of gemcitabine-paclitaxel indicates an improved therapeutic index .\
\
###10942100\
OBJECTIVE	To investigate the effect of understanding their own disease by patients with metastatic breast cancer on their survival potential after being informed by their physician .\
METHODS	Two hundred and fourteen women with metastatic breast cancer who participated in a multi-institutional , randomized phase III trial ( Japan Clinical Oncology Group ( JCOG ) Study 8808 ) were asked whether they understood their own disease after being given information about the clinical trial .\
METHODS	They were classified into two groups on the basis of whether they understood or not .\
METHODS	We estimated their survival after the time of registration and derived relative hazard ratios from Cox 's proportional hazards model .\
RESULTS	There were 190 patients in the ` better understanding ' group and 24 in the ` poor understanding ' group .\
RESULTS	Median survival times after registration were 28.3 and 16.1 months , respectively .\
RESULTS	The ` better understanding ' group showed a significant difference from the ` poor understanding ' group ( p = 0.016 ) .\
RESULTS	In multivariate regression analysis , patients who did not understand still showed poorer survival than those who understood ( hazard ratio = 2.09 ; 95 % confidence interval ( CI ) 1.16-3 .78 ; p = 0.014 ) .\
CONCLUSIONS	These results support the supposition that patients ' understanding of information about their disease may influence their survival .\
CONCLUSIONS	Thus , it is important to evaluate patients ' recognition about information even after obtaining their consent .\
CONCLUSIONS	However , further investigation is needed to clarify the exact nature of this relationship .\
\
###17931798\
OBJECTIVE	The purpose of this study is to introduce a new prognostic index for patients with brain metastases and compare it with three published indices .\
OBJECTIVE	Treatment for brain metastases varies widely .\
OBJECTIVE	A sound prognostic index is thus important to guide both clinical decision making and outcomes research .\
METHODS	A new index was developed because of limitations in the three existing indices and new data ( Radiation Therapy Oncology Group 9508 ) are available since the others were developed .\
METHODS	All four indices were compared using the Radiation Therapy Oncology Group database of 1,960 patients with brain metastases from five randomized trials .\
METHODS	The ability of the four indices to distinguish its separate classes was determined statistically .\
METHODS	Advantages and disadvantages of each index are discussed .\
RESULTS	Recursive partitioning analysis ( RPA ) and the new Graded Prognostic Assessment ( GPA ) had the most statistically significant differences between classes ( p < 0.001 for all classes ) .\
CONCLUSIONS	The new index , the GPA , is as prognostic as the RPA and more prognostic than the other indices .\
CONCLUSIONS	The GPA is the least subjective , most quantitative and easiest to use of the four indices .\
CONCLUSIONS	Future clinical trials should compare the GPA with the RPA to prospectively validate these findings .\
\
###15607399\
OBJECTIVE	The purpose of this randomized study was to investigate the performance of single - and dual-chamber tachyarrhythmia detection algorithms .\
BACKGROUND	A proposed benefit of dual-chamber implantable cardioverter-defibrillators ( ICDs ) is improved specificity of tachyarrhythmia detection .\
METHODS	All ICD candidates received a dual-chamber ICD and were randomized to programmed single - or dual-chamber detection .\
METHODS	Of 60 patients ( 47 male , age 58 + / - 14 years , left ventricular ejection fraction 30 % ) , 29 had single-chamber and 31 had dual-chamber settings .\
METHODS	The detection results were corrected for multiple episodes within a patient with the generalized estimating equations method .\
RESULTS	A total of 653 spontaneous arrhythmia episodes ( 39 patients ) were classified by the investigators ; 391 episodes were ventricular tachyarrhythmia ( 32 patients ) .\
RESULTS	All episodes of ventricular tachyarrhythmias were appropriately detected in both settings .\
RESULTS	In 25 patients , 262 episodes of atrial tachyarrhythmias were recorded .\
RESULTS	Detection was inappropriate for 109 atrial tachyarrhythmia episodes ( 42 % , 18 patients ) .\
RESULTS	Rejection of atrial tachyarrhythmias was not significantly different between both groups ( p = 0.55 ) .\
RESULTS	Episodes of atrial flutter/tachycardia were significantly more misclassified ( p = 0.001 ) .\
RESULTS	Overall , no significant difference in tachyarrhythmia detection ( atrial and ventricular ) between both settings was demonstrated ( p = 0.77 ) .\
CONCLUSIONS	The applied detection criteria in dual-chamber devices do not offer benefits in the rejection of atrial tachyarrhythmias .\
CONCLUSIONS	Discrimination of atrial tachyarrhythmias with a stable atrioventricular relationship remains a challenge .\
\
###24526247\
OBJECTIVE	TREATMENT of patients with chronic low back pain ( CLBP ) aims to reduce disability , improve functional capacity , and participation .\
OBJECTIVE	Time contingent prescription of analgesics is a treatment modality in CLBP .\
OBJECTIVE	The impact of analgesics on functional capacity is unknown .\
OBJECTIVE	Aim of the study was to explore the effect of analgesics on functioning measured by functional capacity evaluation , and self-reported disability in patients with CLBP .\
METHODS	Explorative Randomized Placebo-Controlled Clinical Trial was performed in an outpatient pain rehabilitation setting on patients waiting for rehabilitation .\
METHODS	Included patients had low back pain lasting > 3 months , visual analogue scale worst pain 4.0 cm , and age > 18 years .\
METHODS	Outcome measures before ( T0 ) and after treatment ( T1 ) : functional capacity , pain intensity , Roland Morris Disability Questionnaire .\
METHODS	T1 : global perceived pain relief .\
METHODS	Patient characteristics and psychological questionnaires were assessed .\
METHODS	Fifty patients were included in this study and were randomly assigned to 2 weeks treatment or placebo .\
METHODS	acetaminophen/tramadol 325 mg/37 .5 mg per capsule .\
METHODS	Dose : maximum acetaminophen 1,950 mg and tramadol 225 mg per day ; treatment and placebo titrated identically .\
METHODS	Compliance and side-effects were monitored .\
METHODS	TREATMENT effects between groups over time were compared .\
RESULTS	One patient ( treatment group ) was lost to follow-up .\
RESULTS	Forty-nine patients remained in the study .\
RESULTS	TREATMENT effects in primary outcomes did not differ significantly between groups .\
RESULTS	A subgroup of 10 ( 42 % ) patients ( treatment group ) reported global pain relief ( responders ) who reduced self-reported disability ( p < 0.05 ) .\
RESULTS	Responders had significantly lower catastrophizing scores .\
CONCLUSIONS	Overall treatment effects were small and non-significant .\
CONCLUSIONS	A subgroup , however , reported improved functioning as a result of treatment .\
CONCLUSIONS	Responders had lower catastrophizing scores .\
\
###20889142\
BACKGROUND	Neuroendocrine hormones , which regulate both homeostasis and stress responses , provide homeostatic recovery and sleep suppression to brains under stress .\
BACKGROUND	We examined the effects of total sleep deprivation on subsequent enhancement of aversive event memory , implicit fear recognition , and fear conditioning in healthy humans .\
METHODS	Three different recognitions ( explicit event , implicit emotion , and physiological response ) were assessed in two groups of 14 healthy young volunteers ( sleep control and sleep deprived ) with aversive ( motor vehicle accident films ) and nonaversive episodic memory stimuli .\
METHODS	Both groups were tested on Day 1 of the experiment and again on Days 3 and 10 ; the sleep-deprived group was totally deprived of initial nocturnal sleep after the first trial on Day 1 .\
RESULTS	Event recognition performances were similar in both groups throughout the study .\
RESULTS	Implicit fear recognition remained high for aversive stimuli , with generalization of implicit fear recognition occurring for nonaversive stimuli on Day 3 in the sleep control group .\
RESULTS	Physiological fear and generalized fear responses were observed for every episode , and delayed enhancement of physiological response was only observed for misidentified aversive episodes in the sleep control group on Day 3 .\
RESULTS	However , in the sleep-deprived group , generalization of implicit fear recognition for nonaversive stimuli on Day 3 and all physiological and generalized fear responses on Days 3 and 10 were comprehensively extinguished .\
CONCLUSIONS	Clinically , trauma-exposed victims often experience acute insomnia , indicating that such insomnia might provide prophylactic benefits in reducing the development of posttraumatic stress disorder via extinction of the fear-magnifying effects of memory .\
\
###22822092\
BACKGROUND	Hypovitaminosis D is common in chronic kidney disease ( CKD ) .\
BACKGROUND	Effects of 25-hydroxyvitamin D replenishment in CKD are not well described .\
METHODS	An 8-week randomized , placebo-controlled , double-blind parallel intervention study was conducted in haemodialysis ( HD ) and non-HD CKD patients .\
METHODS	Treatment consisted of 40,000 IU of cholecalciferol orally per week .\
METHODS	Plasma 25-hydroxyvitamin D ( 25-OHD ) , plasma 1,25-dihydroxyvitamin D ( 1,25-diOHD ) , plasma parathyroid hormone ( PTH ) , serum phosphate , ionized serum calcium and serum fibroblast growth factor 23 ( FGF-23 ) were analysed .\
METHODS	We also investigated biomarkers related to cardiovascular disease ( plasma D-dimer , plasma fibrinogen , plasma von Willebrand factor antigen and activity , plasma interleukin 6 , plasma C-reactive protein , blood pressure , aortic augmentation index , aortic pulse wave velocity and 24-h urinary protein loss ) .\
METHODS	Objective and subjective health variables were assessed ( muscle function tests , visual analogue scores and Health Assessment Questionnaire ) .\
RESULTS	Fifty-two CKD patients with 25-OHD < 50 nmol/L at screening were included .\
RESULTS	Cholecalciferol supplementation led to a significant increase to a median of 155 nmol/L 25-OHD ( interquartile range 137-173 nmol/L ) in treated patients ( n = 25 , P < 0.001 ) .\
RESULTS	In non-HD patients , we saw a significant increase in 1,25-diOHD ( n = 13 , P < 0.01 ) and a lowering of PTH ( n = 13 , P < 0.001 ) .\
RESULTS	This was not observed in HD patients .\
RESULTS	Cholecalciferol supplementation caused a significant increase in serum calcium and FGF-23 .\
CONCLUSIONS	25-OHD replenishment was effectively obtained with the employed cholecalciferol dosing .\
CONCLUSIONS	In non-HD patients , it had favourable effects on 1,25-diOHD and PTH .\
CONCLUSIONS	Vitamin D-supplemented patients must be monitored for hypercalcaemia .\
CONCLUSIONS	The present study could not identify significant pleiotropic effects of 25-OHD replenishment .\
\
###12616822\
OBJECTIVE	To investigate whether short-term N-acetylcysteine ( NAC ) infusion administered before and during extensive abdominal surgery could modify the progression of early postoperative organ dysfunction and systemic inflammatory response .\
METHODS	After randomisation the treatment group ( n = 47 ) received NAC ( 150 mg kg-1 bolus followed by a continuous infusion of 12 mg kg-1 h-1 ) and the placebo group ( n = 46 ) received the same volume of 5 % dextrose during surgery .\
METHODS	Clinical progress was monitored by the Multiple organ dysfunction score , systemic inflammatory response by serum procalcitonin ( PCT ) , C-reactive protein ( CRP ) and microalbuminuria during the first 3 postoperative days .\
METHODS	Mann-Whitney and chi 2 tests were used for statistical analysis .\
RESULTS	There was no significant difference between the two groups regarding the MODS , organ dysfunction , length of intensive care stay , days of mechanical ventilation and mortality .\
RESULTS	PCT and microalbuminuria did not differ significantly .\
RESULTS	Significantly lower CRP levels were found in the NAC group on day one and two [ t24 : median : 84.5 interquartile range : ( 62.48-120 .25 ) vs. 118 ( 86-137 ) mg/l ; p = 0.020 ; t48 : 136 ( 103-232 ) vs. 195 ( 154.5-252 ) mg/l p = 0.013 , NAC vs. placebo ] .\
CONCLUSIONS	The results of this study do not support the routine use of NAC as a prophylactic drug during surgery , and reinforce previous evidence which challenge the indication of NAC in the critically ill patient .\
\
###17309139\
OBJECTIVE	To compare T-tube and pressure support ventilation ( PSV ) as two methods of mechanical ventilation weaning of patients with chronic obstructive pulmonary disease ( COPD ) after failed extubation .\
METHODS	A prospective randomized trial carried out at the multidisciplinary intensive care unit ( ICU ) over 2 years included 136 patients with COPD who required mechanical ventilation longer than 24 hours .\
METHODS	The patients who could be weaned from mechanical ventilation were randomized to either a T-tube or PSV 2-hour spontaneous breathing trial .\
METHODS	The patients in whom 2-hour trial was successful were extubated and excluded from further research .\
METHODS	Patients in whom 2-hour trial failed had mechanical ventilation reinstated and underwent the same weaning procedure after 24 hours in case they fulfilled the weaning criteria .\
METHODS	The weaning outcome was assessed according to the following parameters : extubation success , mechanical ventilation duration , time spent in ICU , reintubation rate , and mortality rate .\
RESULTS	Two-hour trial failed in 31 patients in T-tube and 32 patients in PSV group , of whom 17 and 23 , respectively , were successfully extubated ( P < 0.001 , chi ( 2 ) test ) .\
RESULTS	Mechanical ventilation lasted significantly longer in T-tube than in PSV group ( 187 hours vs 163 hours , respectively , P < 0.001 , Mann-Whitney test ) .\
RESULTS	Also , patients in T-tube group spent significantly more time in ICU than patients in PVS group ( 241 hours [ interquartile range 211-268 ] vs 210 hours [ 211-268 ] , respectively , P < 0.001 , Mann-Whitney test ) .\
RESULTS	Reintubation was required in 8 and 6 patients in T-tube and PVS group , respectively , and death occurred in 4 and 2 patients , respectively , during ICU stay .\
CONCLUSIONS	Patients with COPD who failed the 2-hour spontaneous breathing trial had more favorable outcome when PVS rather than T-tube method was used for weaning from mechanical ventilation .\
\
###12452227\
OBJECTIVE	To study the effectiveness of intraperitoneal instillation of bupivacaine for postoperative laparoscopic cholecystectomy pain relief , especially specific pain ( visceral pain , shoulder pain and epigastric pain ) .\
METHODS	Eighty ASA ( American Society of Anesthesiologists ) 1 and 2 patients were randomly assigned to receive either 20 ml of 0.5 per cent bupivacaine ( n = 39 ) or the same volume of saline ( n = 41 ) instilled under direct vision into the hepatodiaphragmatic space , near and above the hepatoduodenal ligament and above the gall bladder bed at the end of surgery .\
METHODS	The intensity of visceral pain , shoulder pain and epigastric pain was assessed at 1 , 6 , 24 and 48 h after surgery using a visual analogue scale ( 100 mm VAS ) and verbal rating `` Prince Henry '' pain scale ( VRS ) .\
METHODS	The time when analgesia was first required and total analgesic consumption were also recorded .\
METHODS	t-test , Chi-square , Mann-Whitney U test and Kaplan-Meier survival analysis were used for statistical analysis .\
RESULTS	Patient data were similar in the two groups except for body weight .\
RESULTS	There were no statistical differences between the two groups for the time when analgesia was first ' required , VAS , VRS and total analgesic consumption .\
CONCLUSIONS	In this study , intraperitoneal instillation of bupivacaine does not show any advantage for postoperative analgesia after laparoscopic cholecystectomy .\
\
###18637156\
OBJECTIVE	To evaluate the efficacy , safety/tolerability , and dose-response relationship of imidafenacin in Japanese patients with overactive bladder .\
METHODS	Men and women who had overactive bladder symptoms were randomized equally to double-blind treatment with 0.05 , 0.1 , or 0.25 mg of imidafenacin twice daily or a placebo for 12 weeks , and assessed for efficacy and safety .\
RESULTS	Overall , 401 patients were enrolled and randomized for treatment with 0.1 mg of imidafenacin/day ( 99 patients ) , 0.2 mg of imidafenacin/day ( 100 ) , 0.5 mg of imidafenacin/day ( 101 ) , or a placebo ( 101 ) .\
RESULTS	After 12 weeks of treatment , the number of incontinence episodes was reduced in a dose-dependent manner , and a significant difference between the imidafenacin treatment and the placebo was observed ( P < 0.0001 ) .\
RESULTS	Compared with the placebo , imidafenacin caused significant reductions in urgency incontinence , voiding frequency , and urinary urgency , and a significant increase in the urine volume voided per micturition .\
RESULTS	Imidafenacin was also well tolerated .\
RESULTS	The incidence of dry mouth in the imidafenacin groups increased dose-dependently .\
RESULTS	Even though the percentage of patients receiving 0.5 mg/day who discontinued treatment due to dry mouth was high ( 8.9 % ) , the percentages in the 0.1 mg/day and 0.2 mg/day groups ( 1.0 % and 0.0 % , respectively ) were comparable with that in the placebo group ( 0.0 % ) .\
CONCLUSIONS	Considering the balance between efficacy and safety , 0.1 mg of imidafenacin twice daily appeared to be a clinically appropriate dose for treating overactive bladder .\
CONCLUSIONS	This dose was therefore selected for further evaluation in large-scale phase III studies .\
\
###24552555\
BACKGROUND	Modifiable risk factors , including life-style habits and psychological variables , have been increasingly demonstrated to have an important role in influencing morbidity and mortality in cardiovascular patients , and to account for approximately 90 % of the population risk for cardiac events.Acceptance and Commitment Therapy ( ACT ) has shown effectiveness in promoting healthy behaviors , and improving psychological well-being in patients with chronic physical conditions .\
BACKGROUND	Moreover , a first application of an acceptance-based program in cardiac patients has revealed high treatment satisfaction and initial evidences of effectiveness in increasing heart-healthy behaviour .\
BACKGROUND	However , no clinical trial to date has evaluated the efficacy of an acceptance-based program for the modification of cardiovascular risk factors and the improvement of psychological well-being , compared to usual secondary prevention care .\
METHODS	Approximately 168 patients will be recruited from an outpatient cardiac rehabilitation unit and randomly assigned to receive usual care or usual care + a brief ACT-based intervention .\
METHODS	The ACT group will be administered five group therapy sessions integrating educational topics on heart-healthy behaviours with acceptance and mindfulness skills .\
METHODS	Participants will be assessed at baseline , six weeks later ( post treatment for the ACT condition ) , at six and twelve months follow-up .\
METHODS	A partially-nested design will be used to balance effects due to clustering of participants into small therapy groups .\
METHODS	Primary outcome measures will include biological indicators of cardiovascular risk and self-reported psychological well-being .\
METHODS	Treatment effects will be tested via multilevel modeling after which the mediational role of psychological flexibility will be evaluated .\
CONCLUSIONS	The ACTonHEART study is the first randomized clinical trial designed to evaluate the efficacy of a brief group-administered , ACT-based program to promote health behavior change and psychological well-being among cardiac patients .\
CONCLUSIONS	Results will address the effectiveness of a brief treatment created to simultaneously impact multiple cardiovascular risk factors .\
CONCLUSIONS	Conducted in the context of clinical practice , this trial will potentially offer empirical support to alternative interventions to improve quality of life and reduce mortality and morbidity rates among cardiac patients .\
BACKGROUND	clinicaltrials.gov / ( NCT01909102 ) .\
\
###21444883\
BACKGROUND	This study was designed to determine whether physician-led remote telemedical management ( RTM ) compared with usual care would result in reduced mortality in ambulatory patients with chronic heart failure ( HF ) .\
RESULTS	We enrolled 710 stable chronic HF patients in New York Heart Association functional class II or III with a left ventricular ejection fraction 35 % and a history of HF decompensation within the previous 2 years or with a left ventricular ejection fraction 25 % .\
RESULTS	Patients were randomly assigned ( 1:1 ) to RTM or usual care .\
RESULTS	Remote telemedical management used portable devices for ECG , blood pressure , and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers .\
RESULTS	The primary end point was death from any cause .\
RESULTS	The first secondary end point was a composite of cardiovascular death and hospitalization for HF .\
RESULTS	Baseline characteristics were similar between the RTM ( n = 354 ) and control ( n = 356 ) groups .\
RESULTS	Of the patients assigned to RTM , 287 ( 81 % ) were at least 70 % compliant with daily data transfers and no break for > 30 days ( except during hospitalizations ) .\
RESULTS	The median follow-up was 26 months ( minimum 12 ) , and was 99.9 % complete .\
RESULTS	Compared with usual care , RTM had no significant effect on all-cause mortality ( hazard ratio , 0.97 ; 95 % confidence interval , 0.67 to 1.41 ; P = 0.87 ) or on cardiovascular death or HF hospitalization ( hazard ratio , 0.89 ; 95 % confidence interval , 0.67 to 1.19 ; P = 0.44 ) .\
CONCLUSIONS	In ambulatory patients with chronic HF , RTM compared with usual care was not associated with a reduction in all-cause mortality .\
BACKGROUND	URL : http://www.ClinicalTrials.gov .\
BACKGROUND	Unique identifier : NCT00543881 .\
\
###21223352\
OBJECTIVE	To investigate the effect of a powered toothbrush on colonization of dental plaque by ventilator-associated pneumonia ( VAP ) - associated organisms and dental plaque removal .\
METHODS	Parallel-arm , single-centre , examiner - and analyst-masked randomized controlled trial .\
METHODS	Forty-six adults were recruited within 48 h of admission .\
METHODS	Test intervention : powered toothbrush , control intervention : sponge toothette , both used four times per day for 2 min .\
METHODS	Groups received 20 ml , 0.2 % chlorhexidine mouthwash at each time point .\
RESULTS	The results showed a low prevalence of respiratory pathogens throughout with no statistically significant differences between groups .\
RESULTS	A highly statistically significantly greater reduction in dental plaque was produced by the powered toothbrush compared with the control treatment ; mean plaque index at day 5 , powered toothbrush 0.75 [ 95 % confidence interval ( CI ) 0.53 , 1.00 ] , sponge toothette 1.35 ( 95 % CI 0.95 , 1.74 ) , p = 0.006 .\
RESULTS	Total bacterial viable count was also highly statistically significantly lower in the test group at day 5 ; Log ( 10 ) mean total bacterial counts : powered toothbrush 5.12 ( 95 % CI 4.60 , 5.63 ) , sponge toothette 6.61 ( 95 % CI 5.93 , 7.28 ) , p = 0.002 .\
CONCLUSIONS	Powered toothbrushes are highly effective for plaque removal in intubated patients in a critical unit and should be tested for their potential to reduce VAP incidence and health complications .\
\
###11275919\
OBJECTIVE	Our purpose was to test the hypothesis that converting patients with stable angina to long-acting antianginal medications would improve their functional status , symptom control , treatment satisfaction , and quality of life .\
RESULTS	A single-blind randomized trial of 100 patients with stable coronary artery disease was performed in the outpatient clinic of a Veterans Affairs Health System .\
RESULTS	Outpatients with chronic stable angina taking at least 2 antianginal medications were studied .\
RESULTS	Patients were randomized to one of two treatments : optimal adjustment of their usual antianginal medications or conversion to solely long-acting medications ( long-acting diltiazem + / - nitroglycerin patches + / - atenolol ) with subsequent optimization .\
RESULTS	The primary outcome was the 3-month change in Seattle Angina Questionnaire scores .\
RESULTS	Although no differences in physical limitation scores were noted , patients randomized to receive long-acting medications had improved symptom control ( 3-month improvement in anginal stability [ 19.1 vs 5.6 , P = .02 ] and anginal frequency [ 17.8 vs 5.5 , P = .006 ] ) , more treatment satisfaction ( 3-month improvement of 8.2 vs 3.0 , P = .057 ) , and better quality of life ( 3-month improvement of 11.2 vs 5.6 , P = .09 ) compared with patients whose pretrial medications were optimized .\
RESULTS	The improvement in symptom control was statistically significant .\
CONCLUSIONS	Converting patients with chronic , stable angina to long-acting antianginal medications resulted in substantial improvements in symptom control with a trend toward better treatment satisfaction and quality of life .\
\
###19845550\
OBJECTIVE	The objectives were to compare the efficacy , occurrence of adverse events , and recovery duration of propofol with and without alfentanil for use in procedural sedation in the emergency department ( ED ) .\
METHODS	This was a randomized nonblinded prospective trial of adult patients undergoing procedural sedation for painful procedures in the ED .\
METHODS	Patients with pain before the procedure were given intravenous ( IV ) morphine sulfate until their pain was adequately treated at least 20 minutes before starting the procedure .\
METHODS	Patients received 1 mg/kg propofol either with or without a supplemental dose of 10 mug/kg alfentanil for deep procedural sedation .\
METHODS	Doses , vital signs , nasal end-tidal CO ( 2 ) ( ETCO ( 2 ) ) , pulse oximetry , and bispectral electroencephalographic ( EEG ) analysis scores were recorded .\
METHODS	Subclinical respiratory depression was defined as a change in ETCO ( 2 ) of > 10 mmHg , an oxygen saturation of < 92 % at any time , or an absent ETCO ( 2 ) waveform at any time .\
METHODS	Clinical events related to respiratory depression were noted during the procedure , including the addition of or increase in the flow rate of supplemental oxygen , the use of a bag-valve mask apparatus , airway repositioning , or stimulation to induce breathing .\
METHODS	After the procedure , patients were asked if they experienced pain during the procedure or had recall of the procedure .\
RESULTS	A total of 150 patients were enrolled ; 146 underwent sedation and were included in the analysis .\
RESULTS	Seventy-four patients received propofol , and 71 received propofol with alfentanil .\
RESULTS	No clinically significant complications were noted .\
RESULTS	Subclinical respiratory depression was seen in 24/74 patients in the propofol group and 30/71 patients in the propofol/alfentanil group ( effect size = 9.8 % , 95 % CI = -5.8 % to 25.5 % ) .\
RESULTS	Clinical signs of respiratory depression included an increase in supplemental oxygen use in 25 of the 74 propofol patients and 31 of the 71 propofol/alfentanil patients ( effect size 9.9 % , 95 % CI = -5.9 % to 25.7 % ) , the use of bag-valve mask apparatus in seven patients in the propofol group and 12 in the propofol/alfentanil group ( effect size = 5.6 % , 95 % CI = -3.5 % to 18.4 % ) , airway repositioning in 13 propofol patients and 20 propofol/alfentanil patients ( effect size = 10.6 % , 95 % CI = -3.0 % to 24.2 % ) , and stimulation to induce breathing in 11 propofol patients and 20 propofol/alfentanil patients ( effect size = 13.3 % , 95 % CI = 0.1 % to 26.5 % ) .\
RESULTS	The total time of the procedure was longer for the alfentanil/propofol group ( median = 11 minutes , range = 5-22 minutes ) than for the propofol group ( median = 9 minutes , range = 1 to 43 minutes ; effect size = 1.93 minutes , 95 % CI = 0.73 to 2.58 , p = 0.02 ) .\
RESULTS	Pain during the procedure was reported by 10 of the 74 patients in the propofol group and 7 of the 71 patients in the propofol/alfentanil group ( effect size = 4.5 % , 95 % CI = -6.8 % to 14.1 % ) .\
RESULTS	Recall of some part of the procedure was reported by 12 patients in the propofol group and 9 in the propofol/alfentanil group ( effect size = 3.5 % , 95 % CI = -7.9 % to 15.0 % ) .\
RESULTS	All procedures were successfully completed .\
CONCLUSIONS	The use of supplemental alfentanil with propofol for procedural sedation did not result in a difference in reported pain or recall immediately after the procedure .\
CONCLUSIONS	There was an increase in the proportion of patients who required stimulation to induce respiration during the procedure in patients who received propofol with supplemental alfentanil .\
CONCLUSIONS	The addition of supplemental opioid to procedural sedation with propofol does not appear beneficial .\
\
###11919228\
OBJECTIVE	Quality assessment and assurance are important issues in modern health care .\
OBJECTIVE	For the evaluation of surgical procedures , there are indirect parameters such as complication , recurrence , and survival rates .\
OBJECTIVE	These parameters are of limited value for the individual surgeon , and there is an obvious need for direct parameters .\
OBJECTIVE	We have evaluated criteria by which pathologists can judge the quality or completeness of the resection specimen in a randomized trial for rectal cancer .\
METHODS	The pathology reports of all patients entered onto a Dutch multicenter randomized trial were reviewed .\
METHODS	All participating pathologists had been instructed by workshops and videos in order to obtain standardized pathology work-up .\
METHODS	A three-tiered classification was applied to assess completeness of the total mesorectal excision ( TME ) .\
METHODS	Prognostic value of this classification was tested using log-rank analysis of Kaplan-Meier survival curves using the data of all patients who did not receive any adjuvant treatment .\
RESULTS	Included were 180 patients .\
RESULTS	In 24 % ( n = 43 ) , the mesorectum was incomplete .\
RESULTS	Patients in this group had an increased risk for local and distant recurrence , 36.1 % v. 20.3 % recurrence in the group with a complete mesorectum ( P = .02 ) .\
RESULTS	Follow-up is too short to observe an effect on survival rates .\
CONCLUSIONS	A patient 's prognosis is predicted by applying a classification of macroscopic completeness on a rectal resection specimen .\
CONCLUSIONS	We conclude that pathologists are able to judge the quality of TME for rectal cancer .\
CONCLUSIONS	With this direct interdisciplinary assessment instrument , we establish a new role of the pathologist in quality control .\
\
###12954465\
OBJECTIVE	Frail elderly patients have complex problems that require a multidimensional assessment and a range of treatment goals .\
OBJECTIVE	Goal Attainment Scaling ( GAS ) measures multiple , individualized goals , but its responsiveness in comparative clinical trials has not been established .\
METHODS	We assessed the responsiveness of GAS in a randomized , controlled trial of an interdisciplinary Mobile Geriatric Assessment Team ( MGAT ) in 265 rural frail older adults .\
METHODS	Sensitivity to change was compared with standard measures ; clinical meaningfulness was assessed in relation to a patient and a blinded physician global measure .\
RESULTS	At 3 months follow-up , GAS was the most responsive measure ( standardized response mean 1.22 , Norman 's responsiveness statistic 0.58 ) compared with the Barthel Index ( 1.13 , 0.46 ) , Physical Self-Maintenance Scale ( 0.10 , 0.16 , 0.02 ) , Instrumental Activities of Daily Living ( 0.23 , 0.00 ) , and modified Spitzer Quality of Life Index ( -0.04 , 0.00 ) .\
CONCLUSIONS	Only GAS detected clinically important change associated with the MGAT intervention in these frail elderly patients .\
CONCLUSIONS	Clinometric measures can offer a responsive means of evaluating complex interventions .\
\
###18930200\
OBJECTIVE	To evaluate whether stimulation of endometrium embryo transfer ( SEET ) can improve implantation rate and pregnancy rate ( PR ) for patients undergoing assisted reproductive technology ( ART ) for the first time by injecting embryo culture supernatant into the uterus before blastocyst transfer ( BT ) .\
METHODS	Randomized , controlled trial .\
METHODS	Private in vitro fertilization clinic .\
METHODS	Forty-eight women in the BT group , 48 women in the stimulation group who had culture medium injected into the uterus before BT , and 48 women in the SEET group .\
METHODS	Injection of embryo culture supernatant and injection of culture medium .\
METHODS	Implantation rates and PRs .\
RESULTS	Odds ratios of successful implantation rate for stimulation and SEET in patients with high-grade blastocysts , having BT as reference , were 2.58 and 6.46 without adjustment , and 5.91 and 9.20 after adjusting for basal FSH levels and period of infertility .\
RESULTS	Odds ratios of clinical pregnancies were 2.47 and 4.32 without adjustment , and 4.46 and 5.10 with adjustment , respectively .\
RESULTS	In groups with low-grade blastocysts , such tendencies were not observed .\
CONCLUSIONS	The SEET may be an effective method for increasing implantation rate and PR for first-time ART patients who have a high-grade blastocyst .\
\
###18349029\
BACKGROUND	To determine the activity and tolerability of adding cetuximab to the oxaliplatin and capecitabine ( XELOX ) combination in first-line treatment of metastatic colorectal cancer ( MCC ) .\
METHODS	In a multicenter two-arm phase II trial , patients were randomized to receive oxaliplatin 130 mg/m ( 2 ) on day 1 and capecitabine 1000 mg/m ( 2 ) twice daily on days 1-14 every 3 weeks alone or in combination with standard dose cetuximab .\
METHODS	Treatment was limited to a maximum of six cycles .\
RESULTS	Seventy-four patients with good performance status entered the trial .\
RESULTS	Objective partial response rates after external review and radiological confirmation were 14 % and 41 % in the XELOX and in the XELOX + Cetuximab arm , respectively .\
RESULTS	Stable disease has been observed in 62 % and 35 % of the patients , with 76 % disease control in both arms .\
RESULTS	Cetuximab led to skin rash in 65 % of the patients .\
RESULTS	The median overall survival was 16.5 months for arm A and 20.5 months for arm B.\
RESULTS	The median time to progression was 5.8 months for arm A and 7.2 months for arm B.\
CONCLUSIONS	Differences in response rates between the treatment arms indicate that cetuximab may improve outcome with XELOX .\
CONCLUSIONS	The correct place of the cetuximab , oxaliplatin and fluoropyrimidine combinations in first-line treatment of MCC has to be assessed in phase III trials .\
\
###12464983\
BACKGROUND	Coronary artery bypass grafting ( CABG ) remains the revascularization treatment of choice for patients with severely symptomatic or life-threatening coronary artery disease ( CAD ) .\
BACKGROUND	However , 9 % to 25 % of the patients undergoing CABG will suffer a recurrent ischemic event such as death , recurrent infarction , angina or repeat revascularization .\
BACKGROUND	The pathophysiological processes particular to the CABG procedure that may affect graft endothelial function are most active in the early phase after surgery .\
BACKGROUND	Angiotensin-converting enzyme ( ACE ) inhibition has been shown to be effective in reducing or preventing ischemic events in patients with and without left ventricular dysfunction , and in those at high risk for CAD .\
BACKGROUND	Nonetheless , no large clinical trail has investigated this role of ACE inhibition in preventing ischemic events early after CABG .\
OBJECTIVE	The Ischemia Management with Accupril post bypass Graft via Inhibition of angiotensin coNverting Enzyme ( IMAGINE ) study addressed whether ACE inhibition initiated early after CABG improves short and long term outcomes in patients after CABG .\
METHODS	This multicentre , multinational trial recruited 2204 patients with an uncomplicated course early after CABG from 55 to 65 medical care facilities in Canada , The Netherlands , Belgium and France .\
METHODS	Eligible patients with normal left ventricular function were randomly assigned to placebo or quinapril ( titrated up to 40 mg daily where possible ) within seven to 10 days after CABG .\
METHODS	All patients were followed up closely for a minimum of 12 months after random placement .\
METHODS	The median treatment period is expected to be approximately 27 months .\
\
###16255011\
OBJECTIVE	To assess the effect of 5 mg/day prednisolone on disease progression in patients with early rheumatoid arthritis ( RA ) receiving standardized disease-modifying antirheumatic drug ( DMARD ) therapy .\
METHODS	Patients with active RA of < 2 years ' duration were randomly assigned in a double-blinded manner to receive prednisolone or placebo while starting concomitant DMARD therapy ( gold sodium thiomalate or methotrexate ) .\
METHODS	Hand and foot radiographs were taken at baseline and at 6 , 12 , and 24 months and were evaluated according to the Ratingen score and the total modified Sharp/van der Heijde score ( SHS ) .\
RESULTS	Of 192 included patients , 166 were available for the intent-to-treat analysis ( ITT ) .\
RESULTS	Seventy-six patients completed the study per protocol ( PP ) .\
RESULTS	Radiographic progression ( increase in the Ratingen score ) was significantly less with prednisolone than with placebo .\
RESULTS	The difference in the progression rate between the groups was greatest in the first 6 months .\
RESULTS	At 24 months in the ITT population , the least squares ( LS ) mean difference was 3.14 ( 95 % confidence interval [ 95 % CI ] 0.94 , 5.34 ) , P = 0.006 .\
RESULTS	The results were confirmed by the total SHS in the ITT population ( LS mean difference 7.20 [ 95 % CI 0.93 , 13.47 ] , P = 0.022 ) and with the PP population .\
RESULTS	Clinical and functional outcomes tended to be better and the rate of remissions was higher in the prednisolone group .\
RESULTS	Side effects were observed more frequently in the prednisolone group than in the control group : weight gain ( 4 versus 0 patients ) , hypertension ( 6 versus 2 patients ) , glaucoma ( 3 versus 0 patients ) , Cushing 's syndrome ( 5 versus 0 patients ) , gastric distress ( 9 versus 4 patients ) , and gastric ulcers ( only with concomitant nonsteroidal antiinflammatory drug therapy ; 3 versus 0 patients ) .\
RESULTS	No new lumbar fractures were found in either group .\
CONCLUSIONS	The very low daily dose of 5 mg prednisolone given over 2 years in combination with background DMARD therapy substantially decreased radiographic progression in early RA at low risk .\
\
###21441148\
OBJECTIVE	Treatment options for stroke-related dysphagia are currently limited .\
OBJECTIVE	In this study , we investigated whether noninvasive brain stimulation in combination with swallowing maneuvers facilitates swallowing recovery in dysphagic stroke patients during early stroke convalescence .\
METHODS	Fourteen patients with subacute unilateral hemispheric infarction were randomized to anodal transcranial direct current stimulation ( tDCS ) versus sham stimulation to the sensorimotor cortical representation of swallowing in the unaffected hemisphere over the course of 5 consecutive days with concurrent standardized swallowing maneuvers .\
METHODS	Severity of dysphagia was measured using a validated swallowing scale , Dysphagia Outcome and Severity scale , before the first and after the last session of tDCS or sham .\
METHODS	The effect of tDCS was analyzed in a multivariate linear regression model using changes in Dysphagia Outcome and Severity Scale as the outcome variable after adjusting for the effects of other potential confounding variables such as the National Institutes of Health Stroke Scale and Dysphagia Outcome and Severity scale scores at baseline , acute ischemic lesion volumes , patient age , and time from stroke onset to stimulation .\
RESULTS	Patients who received anodal tDCS gained 2.60 points of improvement in Dysphagia Outcome and Severity scale scores compared to patients in the sham stimulation group who showed an improvement of 1.25 points ( P = 0.019 ) after controlling for the effects of other aforementioned variables .\
RESULTS	Six out 7 ( 86 % ) patients in tDCS stimulation group gained at least 2 points of improvement compared with 3 out 7 ( 43 % ) patients in the sham group ( P = 0.107 ) .\
CONCLUSIONS	Because brain stem swallowing centers have bilateral cortical innervations , measures that enhance cortical input and sensorimotor control of brain stem swallowing may be beneficial for dysphagia recovery .\
\
###18187995\
OBJECTIVE	We compared the efficacy of remifentanil and the combination of alfentanil and sodium nitroprusside on controlled hypotension and bleeding at surgical site .\
METHODS	Thirty ASA I-II patients undergoing tympanoplasty were randomly assigned to remifentanil and alfentanil-sodium nitroprusside groups , equal in number .\
METHODS	Anesthesia was induced with remifentanil or alfentanil combined with propofol and rocuronium , and maintained with remifentanil or alfentanil-sodium nitroprusside infusions combined with propofol .\
METHODS	All patients were ventilated with a mixture of 33 % O2 and 66 % N2O .\
METHODS	Invasive mean arterial blood pressure , heart rate , peripheral oxygen saturation , the amount of bleeding at surgical site , and blood gas values were recorded .\
RESULTS	Controlled hypotension was achieved at a target mean arterial pressure of 60 + / -5 mmHg in both groups .\
RESULTS	Compared to the baseline levels , heart rate values were lower in the remifentanil group ( p < 0.05 ) , and similar in the sodium nitroprusside group ( p > 0.05 ) .\
RESULTS	The amount of bleeding and the dryness of the surgical site were similar in two groups .\
RESULTS	PaCO2 and pH values differed significantly between the two groups at perioperative 1 and 2 hours and in the postoperative 30th minute ( p < 0.05 ) , but the difference was not clinically significant .\
CONCLUSIONS	Our results suggest that remifentanil is effective in obtaining controlled hypotension without an additional potent hypotensive agent and provides appropriate surgical conditions by reducing the amount of bleeding .\
\
###16449396\
OBJECTIVE	Among patients with diabetes , major depression is associated with more diabetic complications , lower medication adherence , and poorer self-care of diabetes .\
OBJECTIVE	We reported earlier that enhanced depression care reduces depression symptoms but not hemoglobin A1c level .\
OBJECTIVE	This study examined effects of depression interventions on self-management among depressed diabetic patients .\
METHODS	A total of 329 patients in 9 primary care clinics were randomized to an evidence-based collaborative depression treatment ( pharmacotherapy , problem-solving treatment , or both in combination ) or usual primary care ( routine medical services ) .\
METHODS	Outcome measures included the Summary of Diabetes Self-Care Activities ( SDSCA ) , reported at baseline and 3 , 6 , and 12 months , and medication non-adherence as assessed by automated pharmacy refill data of oral hypoglycemic agents , lipid-lowering agents , and angiotensin-converting enzyme inhibitors .\
METHODS	We used mixed regression models adjusted for baseline differences to compare the intervention with usual care groups at follow-up assessments .\
RESULTS	During the 12-month intervention period , enhanced depression care and outcomes were not associated with improved diabetes self-care behaviors ( healthy nutrition , physical activity , or smoking cessation ) .\
RESULTS	Relative to the usual care group , the intervention group reported a small decrease in body mass index ( mean difference = 0.70 kg/m2 , 95 % CI , 0.17 to 1.24 kg/m2 ) and a higher rate of nonadherence to oral hypoglycemic agents ( mean difference = -6.3 % , 95 % CI , -11.91 % to -0.71 % ) .\
RESULTS	Adherence to lipid-lowering agents and to antihypertensive medicines was similar for the 2 groups .\
CONCLUSIONS	In general , diabetes self-management did not improve among the enhanced depression treatment group during a 12-month period , except for small between-group differences of limited clinical importance .\
CONCLUSIONS	Research needs to assess whether self-care interventions tailored for specific conditions , in addition to enhanced depression care , can achieve better diabetes and depression outcomes .\
\
###20092954\
BACKGROUND	Uncertainty regarding the accuracy of the computer as a data collection or patient screening tool persists .\
BACKGROUND	Previous research evaluating the validity of computer health surveys have tended to compare those responses to that of paper survey or clinical interview ( as the gold standard ) .\
BACKGROUND	This approach is limited as it assumes that the paper version of the self-report survey is valid and an appropriate gold standard .\
OBJECTIVE	First , to compare the accuracy of computer and paper methods of assessing self-reported smoking and alcohol use in general practice with biochemical measures as gold standard .\
OBJECTIVE	Second , to compare the test re-test reliability of computer administration , paper administration and mixed methods of assessing self-reported smoking status and alcohol use in general practice .\
METHODS	A randomised cross-over design was used .\
METHODS	Consenting patients were randomly assigned to one of four groups ; Group 1 .\
METHODS	C-C : completing a computer survey at the time of that consultation ( Time 1 ) and a computer survey 4-7 days later ( Time 2 ) ; Group 2 .\
METHODS	C-P : completing a computer survey at Time 1 and a paper survey at Time 2 ; Group 3 .\
METHODS	P-C : completing a paper survey at Time 1 and a computer survey at Time 2 ; and Group 4 .\
METHODS	P-P : completing a paper survey at Time 1 and 2 .\
METHODS	At Time 1 all participants also completed biochemical measures to validate self-reported smoking status ( expired air carbon monoxide breath test ) and alcohol consumption ( ethyl alcohol urine assay ) .\
RESULTS	Of the 618 who were eligible , 575 ( 93 % ) consented to completing the Time 1 surveys .\
RESULTS	Of these , 71 % ( N = 411 ) completed Time 2 surveys .\
RESULTS	Compared to CO , the computer smoking self-report survey demonstrated 91 % sensitivity , 94 % specificity , 75 % positive predictive value ( PPV ) and 98 % negative predictive value ( NPV ) .\
RESULTS	The equivalent paper survey demonstrated 86 % sensitivity , 95 % specificity , 80 % PPV , and 96 % NPV .\
RESULTS	Compared to urine assay , the computer alcohol use self-report survey demonstrated 92 % sensitivity , 50 % specificity , 10 % PPV and 99 % NPV .\
RESULTS	The equivalent paper survey demonstrated 75 % sensitivity , 57 % specificity , 6 % PPV , and 98 % NPV .\
RESULTS	Level of agreement of smoking self-reports at Time 1 and Time 2 revealed kappa coefficients ranging from 0.95 to 0.98 in each group and hazardous alcohol use self-reports at Time 1 and Time 2 revealed kappa coefficients ranging from 0.90 to 0.96 in each group .\
CONCLUSIONS	The collection of self-reported health risk information is equally accurate and reliable using computer interface in the general practice setting as traditional paper survey .\
CONCLUSIONS	Computer survey appears highly reliable and accurate for the measurement of smoking status .\
CONCLUSIONS	Further research is needed to confirm the adequacy of the quantity/frequency measure in detecting those who drink alcohol .\
CONCLUSIONS	Interactive computer administered health surveys offer a number of advantages to researchers and clinicians and further research is warranted .\
\
###23061619\
BACKGROUND	Care bundles cluster together several evidence-based practices and , in the intensive care setting , the ventilator care bundle ( VCB ) has been applied widely .\
OBJECTIVE	To determine the effect of monthly feedback on VCB compliance .\
METHODS	Before and after study : primary outcome measure VCB compliance .\
METHODS	Data were collected for 1 year from two metropolitan general intensive care units ( ICU ) on one randomly allocated day per week .\
METHODS	Baseline data from adult ventilated patients were collected during the first 6 months ( phase 1 ) .\
METHODS	During the second 6 months ( phase 2 ) , monthly compliance data were provided to each ICU regarding both ICUs ' performance .\
RESULTS	Both ` all or nothing ' compliance ( when all four VCB elements were complied with ) and overall compliance ( the average compliance of the four elements ) increased between the two phases .\
RESULTS	These increases were mostly small and statistically insignificant .\
RESULTS	Although both measures increased in ICU B , both fell in ICU A. ICU B 's overall compliance increase was statistically significant ( p = 0005 ) , but its ` all or nothing ' compliance increase ( 19 % ) , whilst arguably clinically significant , did not reach statistical significance .\
RESULTS	ICU B achieved increased compliance with all four VCB elements in phase 2 , whereas ICU A achieved increases in two elements ( deep vein thrombosis and gastric ulcer prophylaxis ) .\
RESULTS	Both ICUs achieved 100 % compliance with gastric ulcer prophylaxis for all of phase 2 .\
RESULTS	Head of bed elevation was the least complied with element in phase 1 , and increased in ICU B only in phase 2 .\
CONCLUSIONS	Although the compliance rates with individual elements are encouraging , the results regarding the effect of feedback on VCB compliance were variable .\
CONCLUSIONS	The finding of relatively poor compliance with head of bed elevation is consistent with previous research .\
CONCLUSIONS	Further research is needed to determine the effects of audit and feedback , and which strategies are most effective .\
\
###14977662\
BACKGROUND	Creatine supplementation has been shown to augment training-induced strength gains .\
BACKGROUND	The purpose of this study was to examine the effect of creatine supplementation on recovery of muscle strength after anterior cruciate ligament ( ACL ) reconstruction .\
OBJECTIVE	Creatine supplementation will facilitate strength gains after ACL reconstruction .\
METHODS	Double-blind , prospective , and randomized clinical trial .\
METHODS	Sixty patients were randomized into creatine or placebo groups .\
METHODS	Quadriceps and hamstring strength and power were measured isokinetically .\
METHODS	Hip flexor , abductor , and adductor strengths were measured with a handheld dynamometer prior to surgery and at 6 weeks , 12 weeks , or 6 months after surgery .\
RESULTS	From 6 weeks to 12 weeks after surgery , there were significant increases in strength on the involved side for knee extension ( 47 % ) , knee flexion ( 27 % ) , hip flexion ( 20 % ) , hip abduction ( 9 % ) , and hip adduction ( 17 % ) .\
RESULTS	These strength improvements were unaffected by creatine supplementation with similar effects in the creatine and placebo groups .\
RESULTS	From 6 weeks to 12 weeks after surgery , there were significant increases in power on the involved side for knee extension ( 46 % ) and knee flexion ( 26 % ) , but these effects were not affected by creatine supplementation .\
RESULTS	At 6 months , creatine supplementation did not affect outcome as measured by the single leg hop test for distance or the knee outcome score .\
CONCLUSIONS	The results demonstrate that patients do not benefit from creatine supplementation during the first 12 weeks of rehabilitation after ACL reconstruction .\
\
###21419542\
OBJECTIVE	The aim of the present study was to compare piezoelectric surgery and conventional rotatory osteotomy for mandibular third molar germ extraction to determine the 2 methods ' suitability and the postoperative outcomes .\
METHODS	Mandibular third molar germectomy was performed bilaterally , randomly choosing 1 side for rotatory osteotomy ( rotatory group ) and the other for piezoelectric surgery ( piezo group ) .\
METHODS	The predictor variable was the duration of the surgical procedure .\
METHODS	The outcome variables were the suitability of the method used , bleeding , and the postoperative parameters ( ie , mouth opening range , clinical appearance of soft tissues , exudate , abscess , wound dehiscence , locoregional lymphadenopathy , pain on palpation at the extraction site , persistent edema ) at 7 and 30 days postoperatively .\
METHODS	The patients recorded their subjective postoperative pain daily for 7 days using a visual analog scale .\
METHODS	The Wilcoxon rank-sum test and stepwise logistic regression model with binary variables were used for statistical analysis .\
RESULTS	A total of 26 patients ( mean age 15.4 1.29 years ) were enrolled in the present study .\
RESULTS	The time needed to complete the osteotomy and extraction was significantly greater for the piezo group ( 15.77 6.56 minutes ) than for the rotatory group ( 11.77 6.24 minutes ; P = .028 ) .\
RESULTS	No statistically significant differences emerged between the 2 methods for the other outcome variables considered .\
CONCLUSIONS	Piezoelectric osteotomy proved comparable to the rotatory method in terms of the surgeon 's perception of the suitability of the 2 methods and the related postoperative sequelae .\
CONCLUSIONS	However , piezoelectric osteotomy took longer to complete than the rotatory method .\
\
###22634077\
OBJECTIVE	The purpose of this study was to show the association between changes in clinician self-efficacy and readiness to change and implementation of an asthma management program ( Easy Breathing ) .\
METHODS	A 36 month randomized , controlled trial was conducted involving 24 pediatric practices ( 88 clinicians ) .\
METHODS	Randomized clinicians received interventions designed to enhance clinician self-efficacy and readiness to change which were measured at baseline and 3 years .\
METHODS	Interventions consisted of an educational toolbox , seminars , teleconferences , mini-fellowships , opinion leader visits , clinician-specific feedback , and pay for performance .\
METHODS	The primary outcome was program utilization ( number of children enrolled in Easy Breathing/year ) ; secondary outcomes included development of a written treatment plan and severity-appropriate therapy .\
RESULTS	At baseline , clinicians enrolled 149 147 ( mean SD ) children/clinician/year ; 84 % of children had a written treatment plan and 77 % of plans used severity-appropriate therapy .\
RESULTS	At baseline , higher self-efficacy scores were associated with greater program utilization ( relative rate [ RR ] , 1.34 ; 95 % confidence interval [ CI ] , 1.04-1 .72 ; P = .04 ) but not treatment plan development ( RR , 0.63 ; 95 % CI , 0.29-1 .35 ; P = .23 ) or anti-inflammatory use ( RR , 1.76 ; 95 % CI , 0.92-3 .35 ; P = .09 ) .\
RESULTS	Intervention clinicians participated in 17 interventions over 36 months .\
RESULTS	At study end , self-efficacy scores increased in intervention clinicians compared to control clinicians ( P = .01 ) and more clinicians were in an action stage of change ( P = .001 ) but these changes were not associated with changes in primary or secondary outcomes .\
CONCLUSIONS	Self-efficacy scores correlated with program use at baseline and increased in the intervention arm , but these increases were not associated with greater program-related activities .\
CONCLUSIONS	Self-efficacy may be necessary but not sufficient for behavior change .\
\
###7698380\
OBJECTIVE	To compare the efficacy and complications of oxytocin dose increments at 20 - and 60-min intervals for induction of labor in women with low parity .\
METHODS	One hundred women of low parity requiring induction of labor were randomly allocated to 20 - and 60-min oxytocin dose increments , 50 patients in each group .\
METHODS	The basal oxytocin dose was 1 milliunit/min and doubling of the oxytocin dose was done at intervals of 20 and 60 min .\
RESULTS	The group with 60-min increments had a decreased incidence of uterine hyperstimulation , cesarean section and operative vaginal delivery .\
RESULTS	The induction-delivery interval was similar in both groups .\
CONCLUSIONS	The oxytocin infusion regimen with increments at 60-min intervals is safer than and equally effective as 20-min incremental intervals .\
\
###21921152\
OBJECTIVE	Renal transplant recipients with pre-existing diabetes ( PD ) have reduced graft survival and increased risk of mortality and ischemic heart disease compared with nondiabetic transplant recipients .\
OBJECTIVE	To assess the effect of belatacept in this high-risk group , we evaluated outcomes of the subpopulation with PD from previously published BENEFIT and BENEFIT-EXT trials .\
METHODS	A post hoc analysis evaluated pooled data from BENEFIT ( living donors or standard criteria donors ) and BENEFIT-EXT ( extended criteria donors ) .\
METHODS	Patients were randomized to receive cyclosporine or a more intensive ( MI ) or less intensive ( LI ) belatacept regimen .\
RESULTS	Of 1209 intent-to-treat patients , 336 had PD .\
RESULTS	At 12 months , the belatacept LI arm demonstrated a numerically higher rate of patients surviving with a functioning graft ( 90.4 % MI [ 103 of 114 ] , 92.8 % LI [ 90 of 97 ] , and 80.8 % cyclosporine [ 101 of 125 ] ) , and fewer serious adverse events than cyclosporine or MI patients .\
RESULTS	Three cases of posttransplant lymphoproliferative disorder were reported in LI patients , one involving the central nervous system .\
RESULTS	Higher rates ( % [ 95 % confidence interval ] : 22.8 % MI [ 15.1 to 30.5 ] ; 20.6 % LI [ 12.6 to 28.7 ] ; 14.4 % cyclosporine ( 8.2 to 20.6 ] ) and grades of acute rejection were observed with belatacept .\
RESULTS	Measured GFR ( ml/min per 1.73 m ( 2 ) , 59.8 MI ; 62.5 LI ; 45.4 cyclosporine ) , and cardiovascular risk profile were better for belatacept versus cyclosporine .\
CONCLUSIONS	In post hoc analysis of patients with PD , patient/graft survival and renal function at 12 months were numerically higher with belatacept versus cyclosporine , but not statistically significant .\
CONCLUSIONS	Further study is necessary to confirm the benefits belatacept may provide in these patients .\
\
###10533795\
OBJECTIVE	Current therapy for chronic hepatitis C virus ( HCV ) infection is based on the administration of interferon alpha ( IFN ) alone or in combination with other anti-viral agents .\
OBJECTIVE	However , such therapy is effective in only a minority of selected patients .\
OBJECTIVE	Long-term ursodeoxycholic acid ( UDCA ) treatment has been reported to improve liver function and structure especially in cholestatic disorders .\
OBJECTIVE	We investigated the effect of long-term UDCA treatment on liver function in respect to the severity of chronic liver disease and HCV genotypes .\
METHODS	Forty-five patients with non-cholestatic laparoscopy-biopsy proven HCV-associated chronic hepatitis ( n = 16 ) or cirrhosis ( n = 29 ) who had not responded to , or were unsuitable for IFN , were randomly assigned to receive UDCA ( 600 mg/day ; n = 23 ) or no therapy ( n = 22 ) for 12 months .\
METHODS	At entry , all patients were evaluated by means of conventional and quantitative liver function tests ( LFTs ) , including galactose elimination capacity and antipyrine clearance , HCV antibodies , HCV-RNA and HCV genotypes .\
METHODS	LFTs were measured at 6 and at 12 months , whereas HCV-RNA was determined again after treatment .\
RESULTS	Baseline characteristics were comparable in the two study groups .\
RESULTS	Long-term UDCA therapy was well tolerated .\
RESULTS	Based on the analysis of variance , there was a significant decrease in serum transaminase , LDH and GGT levels in UDCA treated patients .\
RESULTS	By contrast , the activities of these enzymes increased in untreated patients , with AST levels reaching statistical significance only .\
RESULTS	Statistical analysis also showed that the improvement in biochemical markers was more pronounced in UDCA treated patients with liver cirrhosis than in those with chronic hepatitis but was similar in patients with HCV genotype 1b and non-1b .\
RESULTS	However , HCV-RNA was positive in all patients after treatment .\
RESULTS	Quantitative LFTs remained , on average , stable over the 12 months of the trial in all groups .\
CONCLUSIONS	Long-term UDCA treatment is well tolerated in patients with HCV-associated chronic liver disease .\
CONCLUSIONS	The effect appears to be greater in cirrhotics than in patients with chronic hepatitis but is independent of HCV genotypes .\
CONCLUSIONS	Thus , long-term UDCA treatment , despite the absence of an anti-viral effect , seems beneficial in reducing disease activity in patients with chronic hepatitis or cirrhosis who are unsuitable for IFN therapy .\
\
###23340963\
OBJECTIVE	The effect of brewers ' yeast ( 1,3 ) - ( 1,6 ) - beta-D-glucan consumption on the number of common cold episodes in healthy subject was investigated .\
METHODS	In a placebo-controlled , double-blind , randomized , multicentric clinical trial , 162 healthy participants with recurring infections received 900 mg of either placebo ( n = 81 ) or an insoluble yeast ( 1,3 ) - ( 1,6 ) - beta-D-glucan preparation ( n = 81 ) per day over a course of 16 weeks .\
METHODS	Subjects were instructed to document each occurring common cold episode in a diary and to rate ten predefined infection symptoms during an infections period , resulting in a symptom score .\
METHODS	The subjects were examined by the investigator during the episode visit on the 5th day of each cold episode .\
RESULTS	In the per protocol population , supplementation with insoluble yeast ( 1,3 ) - ( 1,6 ) - beta-glucan reduced the number of symptomatic common cold infections by 25 % as compared to placebo ( p = 0.041 ) .\
RESULTS	The mean symptom score was 15 % lower in the beta-glucan as opposed to the placebo group ( p = 0.125 ) .\
RESULTS	Beta-glucan significantly reduced sleep difficulties caused by cold episode as compared to placebo ( p = 0.028 ) .\
RESULTS	Efficacy of yeast beta-glucan was rated better than the placebo both by physicians ( p = 0.004 ) participants ( p = 0.012 ) .\
CONCLUSIONS	The present study demonstrated that yeast beta-glucan preparation increased the body 's potential to defend against invading pathogens .\
\
###12631046\
BACKGROUND	The aim of this study was to determine the impact of sevoflurane anaesthesia on metabolic and endocrine responses to lower abdominal surgery .\
METHODS	A prospective randomized controlled study in 20 patients undergoing abdominal hysterectomy .\
METHODS	Patients were randomly assigned to receive either sevoflurane ( S ) or isoflurane anaesthesia ( I ) .\
METHODS	Using a stable isotope dilution technique , endogenous glucose production ( EGP ) and plasma glucose clearance ( GC ) were determined pre - and postoperatively ( 6,6-2H2-glucose ) .\
METHODS	Plasma concentrations of glucose , insulin , cortisol , epinephrine and norepinephrine were measured preoperatively , 5 min after induction of anaesthesia , during surgery and 2 h after the operation .\
RESULTS	EGP increased in both groups with no intergroup differences ( preop .\
RESULTS	S 12.2 + / - 1.6 , I 12.4 + / - 1.6 ; postop .\
RESULTS	S 16.3 + / - 1.9 * , I 19.0 + / - 3.1 * micromol kg ( -1 ) min ( -1 ) , all values are means + / - SD , * P < 0.05 vs. preop . )\
RESULTS	Plasma glucose concentration increased and GC decreased in both groups .\
RESULTS	There were no differences between groups .\
RESULTS	( Glucose conc .\
RESULTS	mmol l ( -1 ) preop. : S 4.1 + / - 0.3 , I 3.9 + / - 0.5 ; 5 AI S 5.1 + / - 0.6 * , I 5.1 + / - 1.0 * , postop .\
RESULTS	S 7.0 + / - 1.0 * , I 7.1 + / - 1.4 * ; * = P < 0.05 vs. preop. ; GC ml kg ( -1 ) min ( -1 ) preop .\
RESULTS	S 3.0 + / - 0.4 , I 3.2 + / - 0.4 ; postop .\
RESULTS	S 2.4 + / - 0.3 * , I 2.7 + / - 0.3 * ; * =P < 0.05 vs. preop . )\
RESULTS	Insulin plasma concentrations were unchanged .\
RESULTS	Cortisol plasma concentrations increased intra - and postoperatively with no changes between the groups .\
RESULTS	Norepinephrine plasma concentration increased in the S group after induction of anaesthesia .\
RESULTS	I group norepinephrine was increased 2 h after operation and showed no intergroup differences .\
CONCLUSIONS	Sevoflurane , as well as isoflurane , does not prevent the metabolic endocrine responses to surgery .\
\
###22933427\
BACKGROUND	In the Women 's Health Initiative Hormone Trials ( WHI-HT ) , breast cancer risk was increased with estrogen plus progestin ( E+P ) but not with unopposed estrogen ( E-alone ) .\
BACKGROUND	We hypothesized that E+P would preferentially metabolize to 16-hydroxyestrone ( 16-OHE1 ) rather than 2-hydroxyestrone ( 2-OHE1 ) , and that breast cancer risk would be associated with baseline and 1 year changes in estrogen metabolites : positively for 16-OHE1 levels and negatively for levels of 2-OHE-1 and the 2:16 ratio .\
METHODS	In a prospective case-control study nested in the WHI-HT , 845 confirmed breast cancer cases were matched to 1,690 controls by age and ethnicity .\
METHODS	Using stored serum , 2-OHE1 and 16-OHE1 levels were measured by enzyme immunoassay at baseline , and for those randomized to active treatment ( n = 1,259 ) , at 1 year .\
RESULTS	The 1-year increase in 16-OHE1 was greater with E+P than E-alone ( median 55.5 pg/mL vs. 43.5 pg/mL , P < 0.001 ) , but both increased 2-OHE1 by 300 pg/mL .\
RESULTS	Breast cancer risk was modestly associated with higher baseline levels of 2-OHE1 and the 2:16 ratio , and for estrogen receptor + / progesterone + cases only , higher baseline 16-OHE1 levels .\
RESULTS	For those randomized to active treatment , breast cancer risk was associated with greater increase in 2-OHE-1 and the 2:16 ratio , but associations were not significant .\
CONCLUSIONS	Although E+P modestly increased 16-OHE1 more than E-alone , increase in 16-OHE1 was not associated with breast cancer .\
CONCLUSIONS	Study results do not explain differences between the WHI E+P and WHI E-alone breast cancer results but metabolism of oral HT , which may explain smaller than expected increase in breast cancer compared with endogenous estrogens .\
\
###10201454\
OBJECTIVE	Computed tomography ( CT ) - guided celiac plexus neurolysis has been used for controlling the chronic abdominal pain associated with intra-abdominal malignancy and chronic pancreatitis .\
OBJECTIVE	Endoscopic ultrasound ( EUS ) - guided celiac plexus neurolysis has been reported to have some success in controlling pain from pancreatic cancer .\
OBJECTIVE	The aim of this study is to assess the efficacy of EUS-guided celiac plexus block versus CT-guided celiac plexus block for controlling the chronic abdominal pain associated with chronic pancreatitis .\
METHODS	Patients enrolled were randomly assigned to EUS-guided or CT-guided celiac plexus block .\
METHODS	Pain scores were determined pre - and postceliac block for both techniques .\
METHODS	Follow-up was obtained by a nurse at 1 day post-block , then weekly thereafter for 24 wk .\
METHODS	Patients also rated overall experience with these procedures .\
METHODS	The EUS celiac block was performed with a 22-gauge sterile needle inserted into the celiac region with guidance of real-time linear array endosonography followed by injection of 10 ml of bupivacaine ( 0.75 % ) and 3 ml ( 40 mg ) of triamcinolone on both sides of the celiac area .\
RESULTS	Twenty-two consecutive patients ( 10 men , 12 women ) , were ultimately enrolled in this study between 7/1/95 and 12/30/95 ; four patients were excluded for protocol violations .\
RESULTS	We performed EUS-guided celiac block in 10 patients and CT-guided celiac block in eight .\
RESULTS	A significant improvement in pain scores with reduction in pain medication usage occurred in 50 % ( five of 10 ) of patients having the EUS block .\
RESULTS	The mean postprocedure follow-up was 15 weeks ( range : 8-24 wk ) .\
RESULTS	Persistent benefit was experienced by 40 % of patients at 8 wk and by 30 % at 24 wk .\
RESULTS	In the patients with CT block , however , only 25 % ( two of eight ) had relief .\
RESULTS	The mean follow-up was 4 wk ( range : 2-6 wk ) .\
RESULTS	Only 12 % ( one of eight ) had some relief at 12 wk of follow-up .\
RESULTS	There were no complications .\
RESULTS	EUS-guided celiac block was the preferred technique among patients who experienced both techniques .\
RESULTS	A cost comparison between both celiac block techniques shows EUS to be less costly than CT. .\
CONCLUSIONS	EUS-guided celiac block provided more persistent pain relief than CT-guided block and was the preferred technique among the subjects studied .\
CONCLUSIONS	EUS-guided celiac block appears to be a safe , effective , and less costly method for controlling the abdominal pain that can accompany chronic pancreatitis in some patients .\
\
###15889321\
OBJECTIVE	Intensified insulin therapy using rapid acting insulin analogues is advocated in younger type 2 diabetic patients at risk of developing diabetic complications .\
OBJECTIVE	Most patients prefer postprandial insulin injections .\
OBJECTIVE	So far , however , there were no data on glycemic control by postprandial aspart insulin in patients with type 2 diabetes .\
METHODS	To compare blood glucose responsiveness to preprandial vs. postprandial aspart injections , a randomised open intraindividual cross-over trial was carried out .\
METHODS	Blood glucose was measured before and one hour after the three main meals and at bedtime .\
METHODS	18 insulin-naive patients with type 2 diabetes ( age , 60 + / - 3 years ( mean + / - SEM ) , known duration of the disease , 7 + / - 2 years ) participated at this study .\
RESULTS	Both with preprandial and postprandial injections of aspart insulin , the averages of the 7-point blood glucose profiles ( 8.27 + / - 0.50 vs. 8.5 + / - 0.61 mmol/l ) were similar .\
RESULTS	With postprandial aspart insulin , however , 84 % of the blood glucose levels measured one hour after breakfast exceeded > 10 mmol/l in comparison to 38 % with preprandial aspart insulin ( p < 0.05 ) .\
RESULTS	Patients injected similar amounts of basal and aspart insulin on both experimental days ( insulin glargin , 11 + / - 3 U , aspart insulin , 23 + / - 2 vs. 25 + / - 2 U/day , p = 0.4843 ) .\
CONCLUSIONS	Both preprandial and postprandial insulin aspart can be allowed to well-controlled type 2 diabetic patients .\
CONCLUSIONS	However , patients will benefit from the recommendation to inject insulin aspart immediately before meal if food with a high glycemic index such as the continental breakfast is to be consumed .\
\
###14617582\
OBJECTIVE	To examine the efficacy of antagonism of rapacuronium - , mivacurium - , rocuronium - and cisatracurium-induced neuromuscular block at the laryngeal adductors ( LA ) .\
METHODS	One hundred four patients were randomly assigned to one of eight study groups .\
METHODS	They either received rapacuronium 1.5 mg x kg ( -1 ) , mivacurium 0.25 mg x kg ( -1 ) , rocuronium 0.9 mg x kg ( -1 ) or cisatracurium 0.15 mg x kg ( -1 ) .\
METHODS	Patients in each treatment group either received edrophonium ( 0.5 mg x kg ( -1 ) ) at 10 % recovery of the first twitch ( T1 ) of train-of-four ( TOF ) at the LA or were allowed to recover spontaneously from neuromuscular block .\
METHODS	The effect of antagonism on speed of recovery of neuromuscular function at the LA was evaluated .\
RESULTS	The time to recovery to a TOF ratio of 0.9 at the LA , when compared to the spontaneous recovery group , was significantly shortened by the administration of edrophonium in patients receiving rapacuronium [ 19.2 + / - 7.8 vs 26.2 + / - 4.9 ( mean + / - SD ) min ] , rocuronium ( 24.7 + / - 14.3 vs 44.4 + / - 13.0 min ) and cisatracurium ( 24.2 + / - 5.7 vs 35.1 + / - 7.6 min ) .\
RESULTS	Edrophonium administration did not shorten complete recovery from mivacurium-induced block ( 15.7 + / - 8.0 vs 17.6 + / - 6.1 min ) .\
CONCLUSIONS	Recovery from rapacuronium - , rocuronium - or cisatracurium - induced neuromuscular block to a TOF ratio of 0.9 as measured at the LA was shortened by the administration of edrophonium , when compared to spontaneous recovery .\
\
###22668622\
OBJECTIVE	The objective of this study was to evaluate the efficacy and safety of short-term and topical application of amlexanox paste in the treatment of erosive oral lichen planus ( EOLP ) .\
METHODS	A randomized , positive-controlled clinical trial was conducted from September 1 to December 31 , 2009 .\
METHODS	Thirty-eight patients with EOLP received amlexanox paste ( n = 20 ) or dexamethasone paste ( n = 18 ) for 7 days .\
METHODS	Outcome measures included size of erosive area and visual analog scale ( VAS ) scores .\
RESULTS	After 7 days of treatment , both groups showed significant reduction in erosive area and VAS scores ( P < .001 ) .\
RESULTS	There was no difference between groups in the reduction of erosive area ( P = .937 ) and VAS scores ( P = .161 ) .\
RESULTS	None of the patients had severe adverse reactions .\
CONCLUSIONS	Topical application of amlexanox appeared as effective as dexamethasone in the treatment of EOLP and no serious side effects were found in this pilot study .\
\
###10091831\
OBJECTIVE	The purpose of this study in patients with quantitatively determined , poorly developed coronary collaterals was to assess the contribution of ischemic as well as adenosine-induced preconditioning and of collateral recruitment to the development of tolerance against repetitive myocardial ischemia .\
BACKGROUND	The development of myocardial tolerance to repeated ischemia is nowadays interpreted to be due to biochemical adaptation ( i.e. , ischemic preconditioning ) .\
METHODS	In 30 patients undergoing percutaneous transluminal coronary angioplasty , myocardial adaptation to ischemia was measured using intracoronary ( i.c. ) electrocardiographic ( ECG ) ST segment elevation changes obtained from a 0.014-in .\
METHODS	( 0.036 cm ) pressure guidewire positioned distal to the stenosis during three subsequent 2-min balloon occlusions .\
METHODS	Simultaneously , an i.c. pressure-derived collateral flow index ( CFI , no unit ) was determined as the ratio between distal occlusive minus central venous pressure divided by the mean aortic minus central venous pressure .\
METHODS	The study patients were divided into two groups according to the pretreatment with i.c. adenosine ( 2.4 mg/min for 10 min starting 20 min before the first occlusion , n = 15 ) or with normal saline ( control group , n = 15 ) .\
RESULTS	Collateral flow index at the first occlusion was not different between the groups ( 0.15 + / - 0.10 in the adenosine group and 0.13 + / - 0.11 in the control group , p = NS ) , and it increased significantly and similarly to 0.20 + / - 0.14 and to 0.19 + / - 0.10 , respectively ( p < 0.01 ) during the third occlusion .\
RESULTS	The i.c. ECG ST elevation ( normalized for the QRS amplitude ) was not different between the two groups at the first occlusion ( 0.25 + / - 0.13 in the adenosine group , 0.25 + / - 0.19 in the control group ) .\
RESULTS	It decreased significantly during subsequent coronary occlusions to 0.20 + / - 0.15 and to 0.17 + / - 0.13 , respectively .\
RESULTS	There was a correlation between the change in CFI ( first to third occlusion ; deltaCFI ) and the respective ST elevation shift ( deltaST ) : deltaST = -0.02 to 0.78 x deltaCFI ; r = 0.54 , p = 0.02 .\
CONCLUSIONS	Even in patients with few coronary collaterals , the myocardial adaptation to repetitive ischemia is closely related to collateral recruitment .\
CONCLUSIONS	Pharmacologic preconditioning using a treatment with i.c. adenosine before angioplasty does not occur .\
CONCLUSIONS	The variable responses of ECG signs of ischemic adaptation to collateral channel opening suggest that ischemic preconditioning is a relevant factor in the development of ischemic tolerance .\
\
###16159705\
OBJECTIVE	To investigate the influence of psychological aspects on glycemic control in type 2 diabetic patients treated with diet alone or diet plus oral antidiabetic medication using meal-related self-monitoring of blood glucose ( SMBG ) .\
OBJECTIVE	These psychological aspects refer to the process of self-management including the tendency to structure situations and activate resources ( self-perception ) , to accept options for action ( self-reflection ) and to believe in self-efficacy ( self-regulation ) .\
METHODS	In a randomized controlled 6-month group comparison study , one group ( n = 113 ; mean age 58.7 years ) used a blood glucose monitoring device , kept a blood glucose/eating diary and received standardized counseling focusing on self-perception , self-reflection and self-regulation .\
METHODS	A control group ( n = 110 ; mean age 60.5 years ) received non-standardized counseling on diet and lifestyle .\
RESULTS	Statistically significant endpoint differences between the SMBG and the control group were seen in glycemic control ( p = 0.0086 ) and the well-being item ` depression ' ( p = 0.032 ) .\
RESULTS	All aspects of counseling were influenced by SMBG with the extent of self-perception and self-reflection gradually increasing over time .\
RESULTS	Three HbA1c response types were identified among SMBG patients : continuous-achievers , late-achievers and non-achievers .\
CONCLUSIONS	This study identified processes ( structuring the situation and activating resources , accepting options for action and believing in self-efficacy ) which lead to a change in the metabolic profile .\
CONCLUSIONS	SMBG coupled with structured counseling provided patients with a tool for taking on more self-control and resulted in an improved outlook on life .\
CONCLUSIONS	This short-term intervention involved a structured counseling algorithm which requires 5-10 min of physician-patient contact and a structured documentation of metabolic control by the patient and can be taught by a diabetes training team within 4 h.\
CONCLUSIONS	The identification of the different response types might be of importance in clinical practice as it enables the physician to determine the right counseling option .\
\
###23403860\
BACKGROUND	The authors piloted an HIV testing and counseling ( HTC ) approach using respondent-driven sampling ( RDS ) , financial incentives , and persons living with HIV infection ( PLHIV ) .\
METHODS	Eligible participants were aged 30-60 years , African American or black , and residents of Oakland , CA .\
METHODS	Participants were tested for HIV infection and asked to refer up to 3 others .\
METHODS	The authors compared the efficiency of RDS to conventional outreach-based HTC with the number needed to screen ( NNS ) .\
METHODS	They evaluated the effect of 2 randomly allocated recruitment incentives on the enrollment of high-risk or HIV-positive network associates : a flat incentive ( $ 20 ) for eligible recruits or a conditional incentive ( $ 10-35 ) for eligible recruits in priority groups , such as first-time testers .\
RESULTS	Forty-eight participants ( 10 PLHIV and 38 HIV negative ) initiated recruitment chains resulting in 243 network associates .\
RESULTS	Nine ( 3.7 % ) participants tested HIV positive , of whom 7 ( 78 % ) were previously recognized .\
RESULTS	RDS was more efficient than conventional HTC at identifying any PLHIV ( new or previously recognized ; RDS : NNS = 27 , 95 % CI : 14 to 59 ; conventional : NNS = 154 , 95 % CI : 95 to 270 ) .\
RESULTS	There was no difference between the 2 incentive groups in the likelihood of recruiting at least 1 high-risk HIV-negative or HIV-positive network associate ( adjusted odds ratio = 0.89 , 95 % CI : 0.06 to 13.06 ) or in total number of high-risk HIV-negative or HIV-positive associates ( adjusted odds ratio = 0.79 , 95 % CI : 0.23 to 2.71 ) .\
CONCLUSIONS	Social network HTC strategies may increase demand for HTC and efficiently identify PLHIV .\
CONCLUSIONS	The flat incentive was as successful as the conditional incentive for recruiting high-risk individuals .\
CONCLUSIONS	Unexpectedly , this method also reidentified PLHIV aware of their status .\
\
###21247820\
BACKGROUND	Arsenic ( As ) occurs as monomethylarsonic acid ( MMA ) and dimethylarsinic acid ( DMA ) in humans , and the methylation pattern demonstrates large interindividual differences .\
BACKGROUND	The fraction of urinary MMA is a marker for susceptibility to As-related diseases .\
OBJECTIVE	We evaluated the impact of polymorphisms in five methyltransferase genes on As metabolism in two populations , one in South America and one in Southeast Asia .\
OBJECTIVE	The methyltransferase genes were arsenic ( + III oxidation state ) methyltransferase ( AS3MT ) , DNA-methyltransferase 1a and 3b ( DNMT1a and DNMT3b , respectively ) , phosphatidylethanolamine N-methyltransferase ( PEMT ) , and betaine-homocysteine methyltransferase ( BHMT ) .\
OBJECTIVE	AS3MT expression was analyzed in peripheral blood .\
METHODS	Subjects were women exposed to As in drinking water in the Argentinean Andes [ n = 172 ; median total urinary As ( U-As ) , 200 g/L ] and in rural Bangladesh ( n = 361 ; U-As , 100 g/L ; all in early pregnancy ) .\
METHODS	Urinary As metabolites were measured by high-pressure liquid chromatography/inductively coupled plasma mass spectrometry .\
METHODS	Polymorphisms ( n = 22 ) were genotyped with Sequenom , and AS3MT expression was measured by quantitative real-time polymerase chain reaction using TaqMan expression assays .\
RESULTS	Six AS3MT polymorphisms were significantly associated with As metabolite patterns in both populations ( p 0.01 ) .\
RESULTS	The most frequent AS3MT haplotype in Bangladesh was associated with a higher percentage of MMA ( % MMA ) , and the most frequent haplotype in Argentina was associated with a lower % MMA and a higher percentage of DMA .\
RESULTS	Four polymorphisms in the DNMT genes were associated with metabolite patterns in Bangladesh .\
RESULTS	Noncoding AS3MT polymorphisms affected gene expression of AS3MT in peripheral blood , demonstrating that one functional impact of AS3MT polymorphisms may be altered levels of gene expression .\
CONCLUSIONS	Polymorphisms in AS3MT significantly predicted As metabolism across these two very different populations , suggesting that AS3MT may have an impact on As metabolite patterns in populations worldwide .\
\
###1389761\
OBJECTIVE	To study the effects on myocardial ischaemia of 50 mg of atenolol , 20 mg of slow release nifedipine , and their fixed combination given 12 hourly .\
METHODS	A treadmill exercise test and 24 hour ambulatory electrocardiographic monitoring were carried out after a period of five days off treatment ( control ) and at the end of three weeks of each treatment period .\
METHODS	23 patients with stable angina pectoris , documented coronary artery disease , and a positive exercise test were randomised in a double blind , three way , cross over study .\
RESULTS	Compared with the control , nifedipine significantly induced an increase in resting heart rate of ( mean ( SEM ) ) 14 ( 2 ) beats/min whereas atenolol and the combination significantly reduced it by 24 ( 2 ) and 20 ( 1 ) beats/min respectively .\
RESULTS	The number of exercise tests rendered negative after each intervention was five for nifedipine , nine for atenolol , and 11 for the combination .\
RESULTS	Compared with the control the time to the start of myocardial ischaemia ( 1 mm ST segment depression ) during exercise significantly increased by 3.2 ( 0.6 ) min after nifedipine , by 4.6 ( 0.4 ) min after atenolol , and by 4.6 ( 0.5 ) min after the combination ; rate-pressure product ( beats/min .\
RESULTS	mm Hg ) at 1 mm ST segment depression increased by 2824 ( 970 ) after nifedipine but fell by 4436 ( 900 ) and 4501 ( 719 ) after atenolol and the combination .\
RESULTS	The weekly frequency of angina was reduced from a mean of five while taking nifedipine , to three while taking atenolol , and to two while taking the combination .\
RESULTS	The total ischaemic time during ambulatory monitoring was significantly reduced from 69 ( 17 ) min during control to 37.5 ( 9.8 ) min during nifedipine , to 15.6 ( 5.5 ) min during atenolol , and to 6.5 ( 2.7 ) min during the combination .\
CONCLUSIONS	The undesirable effect of a high basal heart rate induced by nifedipine was neutralised by its combination with atenolol .\
CONCLUSIONS	Whereas atenolol and the combination were equally efficacious in controlling exercise induced ischaemia , the combination was more effective in reducing total ischaemic burden .\
\
###21849660\
BACKGROUND	Although preclinical and epidemiological data suggest that statins may have antineoplastic properties , the impact of statin use on patient survival after a curative resection of stage III colon cancer is unknown .\
METHODS	We conducted a prospective observational study of 842 patients with stage III colon cancer enrolled in a randomized adjuvant chemotherapy trial from April 1999 to May 2001 to investigate the relationship between statin use and survival .\
METHODS	Disease-free survival ( DFS ) , recurrence-free survival ( RFS ) , and overall survival ( OS ) were investigated by Kaplan-Meier curves and log-rank tests in the overall study population and in a subset of patients stratified by KRAS mutation status ( n = 394 ) , and Cox proportional hazards regression was used to assess the simultaneous impact of confounding variables .\
METHODS	All statistical tests were two-sided .\
RESULTS	Among 842 patients , 134 ( 15.9 % ) reported statin use after completing adjuvant chemotherapy .\
RESULTS	DFS among statin users and nonusers was similar ( hazard ratio [ HR ] of cancer recurrence or death = 1.04 , 95 % confidence interval [ CI ] = 0.73 to 1.49 ) .\
RESULTS	RFS and OS were also similar between statin users and nonusers ( adjusted HR of cancer recurrence = 1.14 , 95 % CI = 0.77 to 1.69 ; adjusted HR of death = 1.15 , 95 % CI = 0.77 to 1.71 ) .\
RESULTS	Survival outcomes were similar regardless of increasing duration of statin use before cancer diagnosis ( P ( trend ) = .63 , .63 , and .59 for DFS , RFS , and OS , respectively ) .\
RESULTS	The impact of statin use did not differ by tumor KRAS mutation status , with similar DFS , RFS , and OS for statin use among mutant and wild-type subgroups ( P ( interaction ) = .84 , .67 , and .98 for DFS , RFS , and OS , respectively ) .\
CONCLUSIONS	Statin use during and after adjuvant chemotherapy was not associated with improved DFS , RFS , or OS in patients with stage III colon cancer , regardless of KRAS mutation status .\
\
###16398803\
BACKGROUND	Topical nitroglycerin ( GTN ) is one of the medical treatments of choice in chronic anal fissure .\
BACKGROUND	The present prospective , randomized , clinical trial was conducted to study the symptomatic relief , healing , and changes in the maximum anal resting pressure ( MARP ) in patients with chronic anal fissure comparing topical GTN and lateral sphincterotomy .\
METHODS	Forty consecutive patients with chronic anal fissure were randomized for treatment with either topical GTN or internal sphincterotomy ( 20 patients in each group ) .\
METHODS	Anal manometry was done before treatment in all patients , and 1 h after application of GTN or sphincterotomy .\
METHODS	Patients were followed at 2-weekly intervals for 6 weeks for symptomatic relief and healing .\
RESULTS	Both GTN and sphincterotomy brought about a highly significant , but comparable drop in the MARP after treatment ( P < 0.0001 in both groups ) .\
RESULTS	Sphincterotomy relieved pain much earlier compared to GTN ( 70 % vs 40 % at 2 weeks , P = 0.0032 ) ; but after 4 weeks of treatment , pain relief in both groups was comparable .\
RESULTS	Healing in the sphincterotomy group was also earlier than with GTN ( 55 % vs 0 % at 2 weeks , P < 0.0001 ; and 85 % vs 30 % at 4 weeks , P < 0.0001 ) ; but after 6 weeks , healing in both groups was comparable .\
RESULTS	Sphincterotomy had a significant incidence of minor , short-term complications ; it also required surgical expertise , theatre time , and day-care beds .\
RESULTS	Nitroglycerin is safe , with mild and tolerable side-effects of headache and local burning sensation .\
CONCLUSIONS	Topical GTN should be the initial treatment in chronic anal fissure .\
CONCLUSIONS	Lateral sphincterotomy should be reserved for patients with severe disabling pain ( because pain relief is much faster ) , and for patients not responding to at least 4 weeks of GTN therapy .\
\
###20150572\
BACKGROUND	Bevacizumab , the anti-vascular endothelial growth factor agent , provides clinical benefit when combined with platinum-based chemotherapy in first-line advanced non-small-cell lung cancer .\
BACKGROUND	We report the final overall survival ( OS ) analysis from the phase III AVAiL trial .\
METHODS	Patients ( n = 1043 ) received cisplatin 80 mg/m ( 2 ) and gemcitabine 1250 mg/m ( 2 ) for up to six cycles plus bevacizumab 7.5 mg/kg ( n = 345 ) , bevacizumab 15 mg/kg ( n = 351 ) or placebo ( n = 347 ) every 3 weeks until progression .\
METHODS	Primary end point was progression-free survival ( PFS ) ; OS was a secondary end point .\
RESULTS	Significant PFS prolongation with bevacizumab compared with placebo was maintained with longer follow-up \{ hazard ratio ( HR ) [ 95 % confidence interval ( CI ) ] 0.75 ( 0.64-0 .87 ) , P = 0.0003 and 0.85 ( 0.73-1 .00 ) , P = 0.0456 \} for the 7.5 and 15 mg/kg groups , respectively .\
RESULTS	Median OS was > 13 months in all treatment groups ; nevertheless , OS was not significantly increased with bevacizumab [ HR ( 95 % CI ) 0.93 ( 0.78-1 .11 ) , P = 0.420 and 1.03 ( 0.86-1 .23 ) , P = 0.761 ] for the 7.5 and 15 mg/kg groups , respectively , versus placebo .\
RESULTS	Most patients ( approximately 62 % ) received multiple lines of poststudy treatment .\
RESULTS	Updated safety results are consistent with those previously reported .\
CONCLUSIONS	Final analysis of AVAiL confirms the efficacy of bevacizumab when combined with cisplatin-gemcitabine .\
CONCLUSIONS	The PFS benefit did not translate into a significant OS benefit , possibly due to high use of efficacious second-line therapies .\
\
###16086616\
OBJECTIVE	We tested the hypothesis that topiramate is more effective than placebo in reducing symptoms in patients with treatment-resistant schizophrenia when combined with ongoing antipsychotic medication .\
METHODS	Twenty-six hospitalized treatment-resistant patients with chronic DSM-IV-diagnosed schizophrenia participated in a randomized , double-blind , placebo-controlled trial in which 300 mg/day of topiramate was gradually added to their ongoing treatment ( clozapine , olanzapine , risperidone , or quetiapine ) over two 12-week crossover treatment periods .\
METHODS	Data were collected from April 2003 to November 2003 .\
RESULTS	In intention-to-treat analysis , topiramate was more effective than placebo in reducing Positive and Negative Syndrome Scale general psychopathologic symptoms ( effect size = 0.7 , p = .021 ) , whereas no significant improvement was observed in positive or negative symptoms .\
CONCLUSIONS	Glutamate antagonist topiramate may be an effective adjuvant treatment in reducing general psychopathologic symptoms in patients with schizophrenia resistant to treatment with second-generation antipsychotics .\
\
###17549330\
OBJECTIVE	To compare standardized and functional aphasia tests in patients after acute stroke .\
METHODS	Data were collected at baseline and at 6 months in 2 prospective single-centre studies : one observational study ( study I , n = 119 ) and one randomized trial of moclobemide vs placebo ( study II , n = 89 ) .\
METHODS	Patients with aphasia after acute stroke .\
METHODS	Degree of aphasia was examined using the Coefficient ( Coeff ) in Norsk Grunntest for Afasi ( standardized ) and the Amsterdam-Nijmegen Everyday Language Test ( ANELT ) ( functional ) .\
METHODS	Statistical comparisons were made using one-way analysis of variance and multivariate regression analyses .\
RESULTS	The degree of aphasia measured with Coeff and ANELT correlated closely throughout the study ( r2 = 0.71-0 .87 , p < 0.0001 ) .\
RESULTS	In study I , 24 patients recovered completely within 6 months .\
RESULTS	A Coeff > or = 49 and ANELT > or = 3.5 predicted complete recovery equally well .\
RESULTS	Coeff was sensitive to differentiate between patients with low values on ANELT , whereas ANELT was sensitive to differentiate between patients with high Coeff values .\
CONCLUSIONS	The 2 tests show a close and consistent correlation over time and are equally sensitive to improvement .\
CONCLUSIONS	They have a similar capacity to predict complete recovery .\
CONCLUSIONS	A standardized test appears to be more suitable for patients with aphasia in the acute stage , while a functional test is more suitable in the subacute/chronic stage .\
\
###21504256\
OBJECTIVE	To test whether an interactive voice response ( IVR ) system phone call was equally effective as a nurse-delivered phone call at educating and preparing patients for flexible sigmoidoscopy ( FS ) and colonoscopy examinations .\
METHODS	Three-arm randomized controlled trial .\
METHODS	The trial included patients with upcoming FS or colonoscopy appointments to test the equivalence of an IVR system to nurse-delivered phone calls in reducing appointment nonattendance and inadequate preparation for an examination .\
METHODS	Message timing and satisfaction with the intervention were assessed .\
METHODS	The 3 study conditions included the following : nurse phone call 7 days before the procedure , IVR system call 7 days before the procedure , and IVR system call 3 days before the procedure .\
METHODS	All calls included an appointment reminder , information about preparation for the examination , and encouragement to prepare for and attend the examination .\
RESULTS	A total of 3610 patients were eligible for the study ; of these , 1229 ( 34 % ) were scheduled for FS and 2381 ( 66 % ) for colonoscopy .\
RESULTS	There were no statistically significant differences across the 3 study arms in appointment attendance or adherence to preparation instructions .\
RESULTS	Significantly more patients in IVR conditions reported neutral perceptions about the phone calls , and more patients receiving nurse calls reported very positive perceptions about the phone calls .\
CONCLUSIONS	An IVR system call is as effective as a nurse phone call for ensuring that patients attend appointments and are adequately prepared for endoscopy examinations .\
\
###18926434\
BACKGROUND	Hospitalization for acute decompensated heart failure ( ADHF ) involves substantial morbidity and mortality .\
BACKGROUND	Current management strategies have major limitations , and there has been little progress in the development of newer therapies .\
BACKGROUND	Arginine vasopressin-receptor antagonists may have promise in the treatment of ADHF in view of their ability to facilitate diuresis .\
BACKGROUND	This pilot study was designed to evaluate the efficacy and safety of intravenous conivaptan , a dual arginine vasopressin V ( 1A ) / V ( 2 ) - receptor antagonist , in treating ADHF .\
RESULTS	In a double-blind , multicenter trial , 170 patients hospitalized for worsening heart failure and given standard therapy were randomly assigned to treatment with conivaptan ( 20-mg loading dose followed by 2 successive 24-hour continuous infusions of 40 , 80 , or 120 mg/d ) or placebo .\
RESULTS	The conivaptan and placebo groups did not differ significantly in patient or clinician assessments of global and respiratory status at 48 hours .\
RESULTS	There was no evidence of worsening heart failure in any group .\
RESULTS	Conivaptan at each dosage increased urine output significantly more than placebo at 24 hours ( P < or = .02 ) , with the difference averaging 1.0 to 1.5 L. Decreases in mean body weight with conivaptan 40 and 80 mg/d ( approximately 1-2 kg ) paralleled the increases in urine output but did not reach statistical significance .\
RESULTS	Conivaptan was well tolerated and not associated with clinically important changes in vital signs , electrolyte disturbances , or cardiac rhythm .\
RESULTS	The most common adverse events were infusion-site reactions .\
CONCLUSIONS	When added to standard therapy for ADHF , conivaptan safely improves urine output .\
CONCLUSIONS	Further study of this compound in ADHF may be warranted , especially in view of the limitations of current treatment for this syndrome .\
\
###16082528\
OBJECTIVE	We explored the impact of baseline left ventricular hypertrophy ( LVH ) and losartan treatment on renal and cardiovascular ( CV ) events in 1,513 patients from the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan ( RENAAL ) trial , which studied the effects of losartan on the progression of renal disease and/or death in patients with type 2 diabetes and nephropathy .\
METHODS	LVH was assessed using ECG criteria ( Cornell product and/or Sokolow-Lyon voltage ) .\
METHODS	The risk of renal or CV events was determined by a proportional hazards model fit with treatment allocation and presence of LVH .\
METHODS	Covariates at baseline included age , sex , systolic BP , mean arterial pressure , pulse , proteinuria , serum creatinine , albumin and haemoglobin .\
RESULTS	A total of 187 subjects ( 12 % ) had LVH at baseline .\
RESULTS	Treatment with losartan resulted in a significant decrease in the Cornell product ( -6.2 % ) and Sokolow-Lyon voltage ( -6.3 % ) .\
RESULTS	LVH was shown to be significantly associated with the primary endpoint , which was a composite of doubling of serum creatinine ( DSCR ) , endstage renal disease ( ESRD ) or death ( hazard ratio [ HR ] = 1.44 , p = 0.011 ) , as well as with the composite renal endpoint of DSCR/ESRD ( HR = 1.42 , p = 0.031 ) and CV events ( HR = 1.68 , p = 0.001 ) .\
RESULTS	Losartan treatment of patients with LVH decreased the CV as well as renal risk to a level similar to that of patients without LVH .\
CONCLUSIONS	In patients with type 2 diabetes and nephropathy , LVH is associated with significantly increased risk of CV events and the progression of kidney disease .\
CONCLUSIONS	Importantly , in patients with LVH , losartan reduced the CV as well as the renal risk to a level similar to that seen in subjects without LVH .\
\
###25113389\
BACKGROUND	The evaluation of cardiac contraction could benefit from a connection with the underlying helical structure of cardiac fibers in athletes either completely healthy or with minor common cardiopathies like Bicuspid Aortic Valve ( BAV ) .\
BACKGROUND	This study aims to exploit the potential role of 3D strain to improve the physiological understanding of LV function and modification due to physical activity as a comparative model .\
METHODS	Three age-matched groups of young ( age 20.35.4 ) individuals are prospectively enrolled : 15 normal healthy subjects , 15 healthy athletes , and 20 athletes with bicuspid aortic valve ( BAV ) .\
METHODS	All subjects underwent echocardiographic examination and both 2D and 3D strain analysis .\
RESULTS	All echo parameters were within the normal range in the three groups .\
RESULTS	Global values of end-systolic longitudinal and circumferential strain , assesses by either 2D or 3D analysis , were not significantly different .\
RESULTS	The 3D strain analysis was extended in terms of principal and secondary strain ( PS , SS ) .\
RESULTS	Global PS was very similar , global SS was significantly higher in athletes and displays a modified time course .\
RESULTS	The comparative analysis of strain-lines pattern suggests that the enhancement of LV function is achieved by a more synchronous recruitment of both left - and right-handed helical fibers .\
CONCLUSIONS	3D strain analysis allows a deeper physiological understanding of LV contraction in different types of athletes .\
CONCLUSIONS	Secondary strain , only available in 3D , identifies increase of performances due to physical activity ; this appears to follow from the synergic activation of endocardial and epicardial fibers .\
\
###17822830\
OBJECTIVE	To determine whether using live actors to increase the reality of the scenario improves knowledge retention in Advanced Cardiac Life Support ( ACLS ) Courses .\
OBJECTIVE	MAIN SECONDARY OBJECTIVES : To determine the effects of age , time since graduation from nursing or medicine , sex , medical specialty , and workplace in knowledge retention .\
METHODS	From December 2004 to October 2005 , 19 selected ACLS courses were divided at random in two groups : group A ( ACLS courses with conventional manikins plus live actors ) and group B ( ACLS courses with conventional manikins ) .\
METHODS	The live actors vocalized appropriately to create more realistic scenarios .\
METHODS	The participants ' relevant theoretical knowledge was assessed before the course ( pre-test ) , immediately after the course ( post-test ) , and 6 months after the course ( final-test ) .\
RESULTS	Four hundred and thirty-five participants were recruited and allocated at random allocated to either group A or B. Overall , the data of 225 participants ( 51.7 % ; 111 in group A and 114 in group B ) who completed the entire sequence of pre - , post - , and final-tests were analysed .\
RESULTS	On univariate analysis , the use of live actors , workplace , gender , and healthcare provider profession did not affect pre - , post - , and final-test results ( p > 0.1 ) .\
RESULTS	The results in all three tests correlated negatively with time since medical or nursing graduation ( 95 % C.I. -0.53 to -0.17 , -0.43 to -0.2 , and -0.42 to -0.11 , respectively , p < 0.05 ) and age ( and 95 % C.I. -0.56 to -0.21 , -0.42 to -0.2 , and -0.38 to -0.07 , respectively , p < 0.05 ) .\
CONCLUSIONS	The use of live actors did not affect knowledge retention in this group .\
CONCLUSIONS	Older age and a longer period since graduation were associated with the worst scores and the lowest levels of knowledge retention .\
\
###8498881\
OBJECTIVE	To evaluate the efficacy of alprazolam in the treatment of premenstrual syndrome .\
METHODS	A randomized , double-blind , placebo-controlled , crossover trial of alprazolam during eight menstrual cycles .\
METHODS	Outpatient clinic at the National Institute of Mental Health , Bethesda , Md. .\
METHODS	Twenty-two women with prospectively confirmed premenstrual syndrome entered this study .\
METHODS	All subjects were either self-referred or were referred by their physicians .\
METHODS	All reported having regular menstrual cycle lengths , were taking no medication , and were free of current or recent medical or psychiatric illness .\
METHODS	Two subjects did not complete the trial .\
METHODS	Participants were assigned to receive alprazolam or placebo as follows : cycle 1 , 0.25 mg of alprazolam or placebo three times daily beginning on menstrual cycle day 16 ; cycle 2 , 0.50 mg of alprazolam or placebo three times daily according to the regimen during the first cycle ; cycles 3 and 4 , 0.75 mg of alprazolam or placebo three times daily from menstrual cycle day 16 and continued throughout the fourth menstrual cycle to evaluate the efficacy of relatively long-term ( approximately 6 weeks ) treatment with alprazolam .\
METHODS	Daily self-report symptoms ratings were completed during the entire study period .\
RESULTS	We observed no significant differences in the severity of premenstrual symptom ratings during alprazolam administration compared with placebo on any scale except the Beck Depression Inventory Scale .\
RESULTS	The Beck Depression Inventory ratings demonstrated a statistically ( F1 ,19 = 7.1 , P < .05 ) , but not clinically , significant improvement in depressive symptoms during alprazolam administration compared with placebo .\
CONCLUSIONS	Our findings do not support alprazolam as a uniformly effective treatment for the symptoms of premenstrual syndrome .\
\
###22897649\
BACKGROUND	The usefulness of unipolar electrograms ( EGMs ) has been reported in assessing lesion transmurality and conduction block along ablation lines .\
BACKGROUND	It is unknown whether unipolar and bipolar EGM characteristics predict exit block during pulmonary vein isolation ( PVI ) procedures .\
RESULTS	Twenty patients ( 63 7 years ; 14 males [ 70 % ] ) undergoing PVI with a circular mapping catheter ( CMC ) placed outside each PV ostium were retrospectively studied .\
RESULTS	After entrance block was achieved , pacing at each bipole around the CMC was performed to assess for absence of atrial capture ( exit block ) .\
RESULTS	Bipolar EGMs recorded before pacing were examined for voltage , duration , fractionation , and monophasic morphology .\
RESULTS	Unipolar EGMs were examined for positive and negative amplitude , PQ segment elevation , fractionation , and monophasic morphology .\
RESULTS	The association of these parameters with atrial capture ( absence of exit block ) at each site was analyzed .\
RESULTS	After achievement of entrance block , only 23 of 64 PV antra ( 36 % ) exhibited exit block .\
RESULTS	Unipolar EGMs at sites with persistent capture were more likely to be fractionated and had larger negative deflections .\
RESULTS	Bipolar EGMs at sites with persistent capture showed higher amplitude , longer duration , were more likely to be fractionated , and were less likely to be monophasic .\
RESULTS	In a multivariate logistic regression model , bipolar and unipolar fractionation , bipolar duration , and lack of bipolar monophasic morphology were independently associated with persistent atrial capture .\
CONCLUSIONS	Specific unipolar and bipolar EGM characteristics are associated with left atrium capture after PV antral isolation .\
CONCLUSIONS	These parameters might be useful in predicting the need for further ablation to achieve exit block .\
\
###17078309\
OBJECTIVE	To examine the effects of nicotine on the metabolic and hormonal responses during acute cold exposure .\
METHODS	Participants in this study included 6 men and 5 women between the ages of 19 and 25 years .\
METHODS	Each subject performed 2 cold-air trials ( CATs ) consisting of a 30-minute baseline ( BASE ) period and a 120-minute exposure to 10 degree C air .\
METHODS	One CAT was performed after a nicotine ( NIC ) dosing using a 21-mg transdermal patch , whereas the other CAT was performed after a placebo ( PL ) treatment .\
METHODS	Blood samples for metabolic and hormonal measurements were obtained at the end of BASE and immediately after the cold exposure .\
RESULTS	When examining the sexes separately , there was no difference in norepinephrine between PL and NIC ( P = .066 ) .\
RESULTS	There was also no difference in epinephrine between PL and NIC in either sex ( P = .634 ) .\
RESULTS	From BASE to 120 minutes of the CAT , there was a significant decrease in cortisol ( P = .036 ) , but this response was similar between the 2 treatments ( P = .077 ) .\
RESULTS	Glucose and glycerol concentrations were not different between the PL and NIC treatments .\
RESULTS	At BASE , nonesterified fatty acid ( NEFA ) concentration was lower during PL compared with NIC ( P = .021 ) ; however , at 120 minutes of the CAT , NEFA was greater during PL compared with NIC ( P = .035 ) .\
CONCLUSIONS	During 120 minutes of cold exposure , NIC resulted in alterations in the responses in NEFA , whereas the other blood measurements were not significantly different between the 2 groups .\
\
###23180952\
OBJECTIVE	To investigate whether the addition of probiotics can improve the eradication effect of triple therapy for Helicobacter pylori ( H. pylori ) infection .\
METHODS	This open randomized trial recruited 234 H. pylori positive gastritis patients from seven local centers .\
METHODS	The patients were randomized to one-week standard triple therapy ( omeprazole 20 mg bid , clarithromycin 500 mg bid , and amoxicillin 1000 mg bid ; OCA group , n = 79 ) ; two weeks of pre-treatment with probiotics , containing 3 10 ( 7 ) Lactobacillus acidophilus per day , prior to one week of triple therapy ( POCA group , n = 78 ) ; or one week of triple therapy followed by two weeks of the same probiotics ( OCAP group , n = 77 ) .\
METHODS	Successful eradication was defined as a negative C13 or C14 urease breath test four weeks after triple therapy .\
METHODS	Patients were asked to report associated symptoms at baseline and during follow-up , and side effects related to therapy were recorded .\
METHODS	Data were analyzed by both intention-to-treat ( ITT ) and per-protocol ( PP ) methods .\
RESULTS	PP analysis involved 228 patients , 78 in the OCA , 76 in the POCA and 74 in the OCAP group .\
RESULTS	Successful eradication was observed in 171 patients ; by PP analysis , the eradication rates were significantly higher ( P = 0.007 each ) in the POCA ( 62/76 ; 81.6 % , 95 % CI 72.8 % -90.4 % ) and OCAP ( 61/74 ; 82.4 % , 95 % CI 73.6 % -91.2 % ) groups than in the OCA group ( 48/78 ; 61.5 % , 95 % CI 50.6 % -72.4 % ) .\
RESULTS	ITT analysis also showed that eradication rates were significantly higher in the POCA ( 62/78 ; 79.5 % , 95 % CI 70.4 % -88.6 % ) and OCAP ( 61/77 ; 79.2 % , 95 % CI 70 % -88.4 % ) groups than in the OCA group ( 48/79 ; 60.8 % , 95 % CI 49.9 % -71.7 % ) , ( P = 0.014 and P = 0.015 ) .\
RESULTS	The symptom relieving rates in the POCA , OCAP and OCA groups were 85.5 % , 89.2 % and 87.2 % , respectively .\
RESULTS	Only one of the 228 patients experienced an adverse reaction .\
CONCLUSIONS	Administration of probiotics before or after standard triple therapy may improve H. pylori eradication rates .\
\
###23083494\
OBJECTIVE	To evaluate whether Baby-guard-a new medical device with an ergonomic 3-chamber inflatable abdominal belt-can reduce complications associated with vaginal delivery .\
METHODS	A randomized controlled single-blind prospective study of 80 pregnant women delivering at term was conducted at San Giuseppe Hospital , Empoli , Italy .\
METHODS	In the study group ( n = 40 ) , the abdominal belt was inflated to optimal therapeutic pressures .\
METHODS	In the control group ( n = 40 ) , the abdominal belt was inflated to minimal , non-therapeutic pressures .\
METHODS	Factors relating to maternal , fetal , and labor complications during vaginal delivery were evaluated .\
RESULTS	Compared with the control group , women in the study group experienced a lower incidence of perineal and cervical lacerations ( P < 0.001 ) ; reduced use of the Kristeller maneuver ( P < 0.001 ) ; shorter duration of the second stage of labor ( P < 0.001 ) ; less psychologic and physical fatigue ( P < 0.001 ) ; fewer maternal requests for cesarean delivery during labor ( P < 0.001 ) ; fewer vacuum extractions ( P < 0.01 ) ; and fewer cesarean deliveries ( P < 0.02 ) .\
RESULTS	No neonatal intensive care unit admissions were recorded in the study group versus 7 in the control group ( P < 0.012 ) .\
CONCLUSIONS	Use of the ergonomic 3-chamber inflatable abdominal belt system reduced the incidence of risks associated with vaginal labor .\
CONCLUSIONS	Clinical trials.gov identifier : NCT01566331 .\
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###7799039\
OBJECTIVE	To investigate whether treatment with prolonged low-dose adjuvant chemotherapy could improve survival of patients with axillary node-positive breast cancer .\
METHODS	Four hundred fifty-two patients with axillary node-positive breast cancer who received postoperative irradiation were prospectively randomized in a trial ( European Organization for Research and Treatment of Cancer [ EORTC ] 09771 ) that compared surgery followed by prolonged low-dose chemotherapy versus surgery alone .\
METHODS	Chemotherapy was given for a period of 2 years and consisted of monthly courses of cyclophosphamide 50 mg/m2 orally on days 1 to 14 , methotrexate 15 mg/m2 intravenously on days 1 and 8 , and fluorouracil 350 mg/m2 intravenously on days 1 and 8 ( CMF ) .\
RESULTS	At a median follow-up time of 10 years , the overall survival duration was significantly prolonged in the chemotherapy arm ( hazards ratio , 0.75 ; 95 % confidence interval , 0.56 to 0.99 ; P = .04 ) .\
RESULTS	Ten-year overall survival rates ( + / - SE ) were 59 % ( + / - 3.6 % ) for the chemotherapy arm and 50 % ( + / - 3.7 % ) for the control arm .\
RESULTS	Time to local relapse was significantly prolonged in the chemotherapy arm ( hazards ratio , 0.63 ; 95 % confidence interval , 0.42 to 0.94 ; P = .02 ) .\
RESULTS	Patients with one to three positive axillary nodes and patients with estrogen receptor-negative tumors especially benefited from chemotherapy .\
RESULTS	Toxicity was observed in 93 % of patients .\
CONCLUSIONS	We conclude that prolonged low-dose adjuvant CMF can significantly prolong overall survival in patients with node-positive breast cancer .\
CONCLUSIONS	However , considering the fact that toxicity was still considerable despite reducing the dose of chemotherapy by 50 % , we believe that conventionally dosed short-term regimens are preferable in the treatment of node-positive breast cancer .\
\
###12610006\
OBJECTIVE	Insulin detemir is a soluble basal insulin analog with a unique mechanism of protracted action designed to reduce the variability associated with conventional basal insulins .\
OBJECTIVE	This trial compared the glycemic control , risk of hypoglycemia , and effect on body weight of insulin detemir and NPH insulin in patients with type 1 diabetes treated with rapid-acting insulin aspart at meals .\
METHODS	This study was a 6-month multinational open parallel-group comparison conducted at 46 centers in five countries and included 448 patients with type 1 diabetes randomized 2:1 to insulin detemir or NPH insulin , respectively .\
RESULTS	After 6 months , comparable HbA ( 1c ) levels were found between the two treatment groups .\
RESULTS	Fasting plasma glucose tended to be lower in patients treated with insulin detemir , but this difference was not statistically significant ( -0.76 mmol/l , P = 0.097 ) .\
RESULTS	Within-subject variation in self-measured fasting blood glucose was lower with insulin detemir than with NPH insulin ( SD 3.37 vs. 3.78 mmol/l , P < 0.001 ) .\
RESULTS	Risk of hypoglycemia was 22 % lower with insulin detemir than with NPH insulin ( P < 0.05 ) and 34 % lower for nocturnal ( 2300-0600 ) hypoglycemia ( P < 0.005 ) .\
RESULTS	Nightly plasma glucose profiles were smoother and more stable with insulin detemir ( P = 0.05 ) .\
RESULTS	Body weight was significantly lower with insulin detemir at the end of the trial ( P < 0.001 ) .\
CONCLUSIONS	Treatment with insulin detemir resulted in more predictable glycemic control , with smoother plasma glucose profiles than NPH insulin and a significant reduction in the risk of hypoglycemia .\
CONCLUSIONS	The reduction in body weight with insulin detemir is a potential additional advantage .\
CONCLUSIONS	Regimens optimized for insulin detemir may be able to improve glycemic control beyond that possible with NPH insulin .\
\
###23496092\
BACKGROUND	Laparoscopic surgery performed with a patient in the Trendelenburg position is known to have adverse effects on pulmonary gas exchange and respiratory mechanics .\
BACKGROUND	We supposed that prolonged inspiratory time can improve gas exchange at lower airway pressure .\
METHODS	One hundred patients undergoing gynaecologic laparoscopic surgery were randomly assigned to one of four groups : conventional inspiratory-to-expiratory ( I : E ) ratio ( Group 1 : 2 ) , I : E ratio of 1 : 1 ( Group 1 : 1 ) , 2 : 1 ( Group 2 : 1 ) , or 1 : 2 with external positive end-expiratory pressure ( PEEP ) of 5 cmH2 O ( Group 1 : 2 PEEP ) .\
METHODS	Tidal volume was set to 6 ml/kg , and I : E ratio was adjusted at the onset of pneumoperitoneum .\
METHODS	Arterial blood gas analysis with measurements of partial pressure of arterial oxygen/fraction of inspired oxygen ( PaO2 / FiO2 ) , and physiologic dead space-to-tidal volume ratio ( VD / VT ) was performed 15 min after anaesthetic induction ( T1 ) , and 30 ( T2 ) and 60 min ( T3 ) after onset of CO2 insufflation .\
RESULTS	PaO2 / FiO2 at T3 in Groups 1 : 1 , 2 : 1 , and 1 : 2 PEEP were higher than Group 1 : 2 .\
RESULTS	The partial pressure of arterial carbon dioxide at T3 in Group 2 : 1 was lower than the other groups .\
RESULTS	The VD / VT at T2 and T3 were lower in Groups 1 : 1 and 2 : 1 than Groups 1 : 2 and 1 : 2 PEEP .\
RESULTS	Peak or plateau airway pressure was higher in Group 1 : 2 PEEP than the other groups .\
CONCLUSIONS	A prolonged inspiratory time demonstrated a beneficial effect on oxygenation .\
CONCLUSIONS	Furthermore , it showed better CO2 elimination without elevating the peak or plateau airway pressure compared with applying external PEEP .\
CONCLUSIONS	In terms of gas exchange and respiratory mechanics , a prolonged inspiratory time appears to be superior to applying external PEEP in patients undergoing laparoscopic surgery in the Trendelenburg position .\
\
###9056614\
OBJECTIVE	The relationship between high blood pressure and the incidence of stroke is well established .\
OBJECTIVE	Currently the effects of lowering blood pressure in patients with established cerebrovascular disease is undetermined , and there is continuing concern regarding the treatment of patients soon after a stroke event .\
OBJECTIVE	Angiotensin-converting enzyme inhibitors maintain cerebral blood flow despite lowering blood pressure in patients with heart failure and otherwise uncomplicated hypertension .\
OBJECTIVE	We tested the hypothesis that perindopril , an angiotensin-converting enzyme inhibitor with a gradual onset of action and a minimal first-dose hypotensive effect , lowers blood pressure without adversely affecting cerebral blood flow in patients 2 to 7 days after symptoms of cerebral infarction .\
METHODS	Patients were randomized to receive 15 days of oral perindopril ( 4 mg ) or placebo in a double-blind study .\
METHODS	Blood pressure was monitored semiautomatically .\
METHODS	Cerebral blood flow was calculated from internal carotid artery and vertebral Doppler ultrasound , supplemented by middle cerebral artery blood velocities .\
RESULTS	Twenty-four patients completed the protocol ; four additional patients were withdrawn for reasons unrelated to treatment .\
RESULTS	Patients on perindopril had a placebo-corrected reduction in blood pressure of 19/11 mm Hg .\
RESULTS	Blood pressure remained reduced after 2 weeks of treatment .\
RESULTS	In contrast , total cerebral blood flow was unaffected by perindopril .\
RESULTS	Neurological symptoms improved similarly in both groups .\
CONCLUSIONS	Perindopril was well tolerated and effectively reduced blood pressure without reducing carotid territory blood flow in patients with symptoms of recent cerebral ischemia .\
\
###16505432\
OBJECTIVE	Despite the progress that has been achieved , long-term survival rates in patients with advanced ovarian cancer are still disappointing .\
OBJECTIVE	One attempt to improve results could be the addition of non-cross-resistant drugs to platinum-paclitaxel combination regimens .\
OBJECTIVE	Anthracyclines were among the candidates for incorporation as a third drug into first-line regimens .\
METHODS	We performed a prospectively randomized phase III study comparing carboplatin-paclitaxel ( TC ; area under the curve 5/175 mg/m2 , respectively ) with epirubicin 60 mg/m2 added to the same combination ( TEC ) in previously untreated patients with advanced epithelial ovarian cancer .\
METHODS	All drugs were administered intravenously on day 1 of a 3-week schedule for a planned minimum of six courses .\
RESULTS	Between November 1997 and February 2000 , 1,282 patients were randomly assigned to receive either TC ( 635 patients ) or TEC ( 647 patients ) , respectively .\
RESULTS	Grade 3/4 hematologic and some nonhematologic toxicities ( nausea/emesis , mucositis , and infections ) occurred significantly more frequently in the TEC arm .\
RESULTS	Accordingly , quality-of-life analysis showed inferiority of TEC versus TC .\
RESULTS	Median progression-free survival time was 18.4 months for the TEC arm and 17.9 months for the TC arm ( hazard ratio [ HR ] , 0.95 ; 95 % CI , 0.83 to 1.07 ; P = .3342 ) .\
RESULTS	Median overall survival time was 45.8 months for the TEC arm and 41.0 months for the TC arm ( HR , 0.93 ; 95 % CI , 0.81 to 1.08 ; P = .3652 ) .\
RESULTS	Similar nonsignificant differences were observed when strata were analyzed separately .\
CONCLUSIONS	Addition of epirubicin to TC did not improve survival or time to treatment failure in patients with advanced epithelial ovarian cancer ; therefore , it can not be recommended for clinical use in this population .\
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###24445100\
OBJECTIVE	Targeted interventions to reduce the risk and increase the early detection of melanoma have the potential to save lives .\
OBJECTIVE	We aimed to assess the effect of such an intervention on patient prevention behavior .\
METHODS	We conducted a pilot clustered randomized controlled trial , comparing a targeted screening and education intervention with a conventional information-based campaign in 20 private surgeries in western France .\
METHODS	In the intervention group , 10 general practitioners identified patients at elevated risk for melanoma with a validated assessment tool , the Self-Assessment Melanoma Risk Score ( SAMScore ) , examined their skin , and counseled them using information leaflets .\
METHODS	In the control group , 10 general practitioners displayed a poster and the leaflets in their waiting room and examined patients ' skin at their own discretion .\
METHODS	The main outcome measures were sunbathing and skin self-examinations among patients at elevated risk , assessed 5 months later with a questionnaire .\
RESULTS	Analyses were based on 173 patients .\
RESULTS	Compared with control patients , intervention patients were more likely to remember the campaign ( 81.4 % vs 50.0 % , P = .0001 ) and to correctly identify their elevated risk of melanoma ( 71.1 % vs 42.1 % , P = .001 ) .\
RESULTS	Furthermore , intervention patients had higher levels of prevention behaviors : they were less likely to sunbathe in the summer ( 24.7 % vs 40.8 % , P = .048 ) and more likely to have performed skin self-examinations in the past year ( 52.6 % vs 36.8 % , P = .029 ) .\
RESULTS	The intervention was not associated with any clear adverse effects , although there were trends whereby intervention patients were more likely to worry about melanoma and to consult their general practitioner again about the disease .\
CONCLUSIONS	The combination of use of the SAMScore and general practitioner examination and counseling during consultations is an efficient way to promote patient behaviors that may reduce melanoma risk .\
CONCLUSIONS	Extending the duration of follow-up and demonstrating an impact on morbidity and mortality remain major issues for further research .\
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###8553300\
BACKGROUND	Inhaled steroids are widely used in the treatment of mild to moderate asthma .\
BACKGROUND	However , long term compliance with inhaled steroids is poor and administration of a single daily dose may improve compliance .\
METHODS	A double blind , randomised study was performed to determine whether inhaled steroids given once daily at bedtime are as efficacious as a twice daily regimen in the long term maintenance of moderate asthmatic patients .\
METHODS	Forty adults of mean age 37 years with moderate asthma ( mean ( SE ) forced expiratory volume in one second ( FEV1 ) 73.6 ( 1.4 ) % predicted , mean morning peak expiratory flow ( PEF ) 328 l/min ) were randomised to receive either a twice daily dose ( 400 micrograms morning and bedtime ) of inhaled budesonide ( group A ) or a once daily dose of 800 micrograms ( group B ) and were followed for a period of 12 months .\
METHODS	Asthma symptom scores ( assessed according to a modified Borg scale ) , inhaled beta 2 agonist consumption , and peak expiratory flow rates were recorded daily .\
METHODS	Spirometry and airways responsiveness to methacholine ( PC20 ) were measured at the end of each period of three months of treatment .\
RESULTS	There was no difference between the two groups at baseline and during the follow up period in the PC20 for methacholine .\
RESULTS	However , a difference was seen between the two groups in the mean daily number of beta 2 agonist inhalations ( 1.4 ( 0.1 ) puffs/patient/day in group A v 2.3 ( 0.1 ) in group B ) , the PEF variability ( episodes of decrease in PEF of > 20 % ) ( 0.22 ( 0.01 ) episodes/patient/day in group A v 0.40 ( 0.02 ) in group B ) , and for asthma symptom scores ( 0.30 ( 0.04 ) in group A v 0.42 ( 0.06 ) in group B ) for the 12 month period of the study .\
CONCLUSIONS	Although both regimens provide good clinical control , twice daily doses of 400 micrograms inhaled budesonide are more effective than a single dose of 800 micrograms at bedtime in the long term control of stable moderate asthma .\
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###24118640\
OBJECTIVE	To determine the efficacy and safety of linagliptin in initial combination with metformin in patients with type 2 diabetes .\
METHODS	This 1-year randomised , double-blind study was an extension of a 6-month randomised controlled trial , in which adults with type 2 diabetes received one of six treatment regimens ( linagliptin 2.5 mg plus metformin 500mg bid , linagliptin 2.5 mg plus metformin mg 1000 bid , metformin 1000mg bid , metformin 500mg bid , linagliptin 5mg qd or placebo ) .\
METHODS	In the extension , patients in the first three treatment groups continued their regimen ( non-switched group , n = 333 ) while the metformin 500mg bid , linagliptin 5mg qd and placebo groups were re-randomised to one of the three continuing regimens ( switched group , n = 233 ) .\
RESULTS	All three non-switched groups maintained reductions in glycosylated haemoglobin ( HbA1c ; meanstandard deviation reductions across the 1.5-year period : linagliptin 2.5 plus metformin 1000 bid , -1.631.05 % ; linagliptin 2.5 plus metformin 500 bid , -1.321.06 % ; metformin 1000 bid , -1.250.91 % ) while the switched groups showed additional HbA1c reductions .\
RESULTS	During the extension , there were no clinically meaningful changes in body weight in any group .\
RESULTS	Adverse event rates were similar between groups , with most events being mild or moderate , and the incidence of investigator-defined hypoglycaemia was low , with no severe events .\
CONCLUSIONS	Initial combination of linagliptin and metformin was well tolerated over the 1-year extension period , with low risk of hypoglycaemia , and improved glycaemic control vs. metformin alone .\
CONCLUSIONS	The initial combination of linagliptin and metformin appears to provide a useful treatment option in patients whose blood glucose levels are increased to an extent that metformin monotherapy may not achieve treatment targets .\
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###8597505\
BACKGROUND	The curative rate of surgical resection of squamous cell carcinoma of the esophagus is low .\
BACKGROUND	Reports on the efficacy of preoperative and postoperative chemotherapy are conflicting or have included limited disease or radical surgery alone .\
OBJECTIVE	The authors ' objective was to study the results of chemotherapy on the duration and quality of survival in patients who have undergone palliative surgical resection for esophageal squamous cell carcinoma .\
METHODS	Of 124 patients with histologically proven esophageal squamous cell carcinoma situated more than 5 cm from the upper end of the esophagus , 4 patients were withdrawn for failure to comply with the protocol .\
METHODS	The remaining 120 patients , 116 males and 4 females ( mean age , 57 + / - 9 years ) , were randomly assigned to either a control group who were to receive no chemotherapy ( 68 patients ) or to a group who were to be treated with chemotherapy ( 52 patients ) .\
METHODS	Patients were subdivided into two strata as follows : ( 1 ) stratum I , complete resection of the tumor with lymph node involvement ( 62 patients ) and ( 2 ) stratum ii , incomplete resection leaving macroscopic tumor tissue in situ or with metastases .\
METHODS	Noninclusion criteria were histologically proven tracheobronchial involvement , esotracheal fistula , major alteration of general health status ( Karnofsky score < 50 ) , cerebral or extensive ( > 30 % of parenchyma ) hepatic metastasis , peritoneal carcinomatosis , associated or previously treated upper airway cancer , or , conversely , complete resection of tumor without lymph node involvement .\
METHODS	Chemotherapy was given in 5-day courses , every 28 days , with a maximum of 8 courses .\
METHODS	Cisplatin was administered either as a single dose of 100 mg/m2 at the beginning of the course or as 20 mg/m2/day for 5 days given over 3 hours .\
METHODS	5 - Fluorouracil ( 5-FU ) ( 100 mg/m2/day ) was infused over 24 hours for 5 days .\
METHODS	The duration of treatment ranged from 6 to 8 months .\
METHODS	The main aim was to establish median survival and actuarial survival curves .\
METHODS	The subsidiary aim was to evaluate quality of survival as judged by complications due to treatment and the duration of autonomous oral feeding , that is , without palliative endoscopic treatment .\
METHODS	No difference in survival was noted between the two groups , overall ( median , 14 months ) , or between the strata .\
METHODS	Conversely , significantly more patients in the treated group had hematologic , neurologic , and renal complications compared with the control group .\
METHODS	Four patients died of complications of chemotherapy .\
METHODS	The duration of autonomous oral alimentation was exactly the same in both groups ( median , 12 + months ) .\
CONCLUSIONS	The results of this study suggest that 5-FU and cisplatin are not useful for patients with squamous cell carcinoma of the esophagus who have not undergone curative resection .\
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###16091876\
BACKGROUND	Atopic dermatitis has been thought to be associated with a disturbance in n-6 polyunsaturated fatty acid ( PUFA ) metabolism , but randomized trials investigating the clinical efficacy of oral supplementation with gammalinolenic acid have revealed conflicting results .\
OBJECTIVE	To re-investigate the proposed linkage between PUFA dysregulation and atopic dermatitis .\
METHODS	Plasma levels of linoleic acid ( LA ) , gammalinolenic acid ( GLA ) , dihomogammalinolenic acid ( DGLA ) and arachidonic acid ( AA ) were measured using HPLC in 22 children with atopic dermatitis .\
METHODS	Patients were subdivided into those with elevated total serum IgE ( group A , n = 15 , IgE > +1 SD of age-specific normal values ) and those with normal IgE ( group B , n = 7 ) and compared with children suffering from allergic rhinitis/asthma ( group C , n = 8 ) and with non-atopic controls ( group D , n = 6 ) .\
RESULTS	GLA levels were significantly lower ( p < 0.05 ) in eczema patients with elevated IgE ( A , 0.19 + / - 0.06 % ) and in atopic controls ( C , 0.23 + / - 0.06 % ) than in eczema patients with low IgE ( B , 0.42 + / - 0.19 % ) and non-atopic controls ( D , 0.43 + / - 0.16 % ) .\
RESULTS	There were no significant differences between groups for LIN , DGLA and AA , except for lower LIN levels in atopic controls .\
RESULTS	Correlation of individual LA and GLA values showed significantly steeper regression lines in low-IgE responders ( B and D , k ( x ) = 0.058 ) than in high-IgE responders ( A and C , k ( x ) = 0.012 ; p < 0.02 ) , suggesting impaired delta-6-desaturase function in the latter .\
RESULTS	For the study population as a whole , there was a clear negative correlation between total levels of IgE and GLA ( r ( s ) = -0.64 ) and a moderate negative correlation between total IgE and AA ( r ( s ) = -0.38 ) .\
CONCLUSIONS	Dysregulation of n-6 PUFA metabolism is neither consistently found in nor specifically associated with atopic dermatitis but rather appears to be associated with IgE production and atopy in general .\
CONCLUSIONS	The finding of decreased GLA levels in eczema patients with elevated total IgE and in children with allergic rhinitis and asthma but not in eczema patients with normal total IgE questions the proposed pathophysiologic role of fatty acid dysregulation in atopic dermatitis .\
\
###10759273\
OBJECTIVE	To compare the efficacy of two different regimens of mifepristone followed by misoprostol for medical abortion in women with menstrual delay of < or = 35 days .\
METHODS	Double-blind , randomised controlled trial .\
METHODS	Seventeen centres internationally .\
METHODS	We enrolled 1,589 healthy pregnant women with menstrual delay of < or = 35 days who were requesting nonsurgical abortion .\
METHODS	Within gestational age strata , we randomly assigned women to receive a single oral dose of mifepristone , either 200 mg or 600 mg , followed in 48 h by misoprostol 400 microg by mouth .\
METHODS	We concealed the allocation assignments from investigators and participants and maintained double-blinding throughout the study .\
METHODS	Complete abortion was the principal outcome measure .\
METHODS	We also compared rates of side effects such as abdominal pain .\
RESULTS	The complete abortion rate with the lower dose of mifepristone was similar to that with the higher dose ( 89.3 % vs 88.1 % ) The crude relative risk of failure to achieve complete abortion with the 200 mg dose compared with the 600 mg dose was 0.9 ( 95 % CI 0.7 to 1.2 ) .\
RESULTS	The likelihood of complete abortion was inversely related to gestational age , although this finding is exploratory in nature .\
RESULTS	Among failures the percentage of women with continuing pregnancies increased from 1.4 % at menstrual delay of two weeks or less to 9.0 % when the delay was 4-5 weeks .\
RESULTS	Low efficacy led to stopping enrolment at 29 to 35 days ' menstrual delay .\
RESULTS	Stopping criteria were also met at completion of the study in the group with 22-28 days ' menstrual delay .\
RESULTS	No significant differences emerged in the frequency of side effects between the two mifepristone groups .\
CONCLUSIONS	Both regimens had similar efficacy .\
CONCLUSIONS	Women with a menstrual delay of four to five weeks had twice the risk of failure to abort compared with those who received treatment within two weeks of the expected menses .\
CONCLUSIONS	The efficacy of the mifepristone-prostaglandin regimen was not reduced by decreasing the dose of mifepristone from 600 mg to 200 mg .\
CONCLUSIONS	The regimens of 600 mg or 200 mg of mifepristone , followed by a single oral dose of misoprostol 400 microg 48 hours later , were not sufficiently efficient in inducing abortion when the menstrual delay was > 21 days .\
\
###17307536\
OBJECTIVE	To report the neurodevelopmental outcome of infants enrolled in a randomized multicenter trial of early inhaled nitric oxide ( iNO ) in term and near-term neonates with hypoxic respiratory failure and pulmonary hypertension .\
METHODS	Neonates born at > or = 34 weeks gestation who required assisted ventilation and had an oxygenation index > or = 15 and < 25 were randomized to an early iNO group or a control group .\
METHODS	A comprehensive neurodevelopmental assessment of survivors was performed at age 18 to 24 months .\
RESULTS	The trial enrolled 299 infants , of which 266 ( 89 % ) survived to age 18 to 24 months ( 136 in the early iNO group and 130 in the control group ) .\
RESULTS	Follow-up evaluations were done on 234 ( 88 % ) of surviving infants .\
RESULTS	There were no differences between the 2 groups in the incidence of neurodevelopmental impairment ( early iNO , 27 % ; control , 25 % ) and hearing impairment ( early iNO , 23 % ; control , 24 % ) .\
RESULTS	Mental development index scores were similar in the 2 groups ; however , psychomotor developmental index scores were significantly higher in the control group ( early iNO , 89 + / - 17.7 ; control , 93.5 + / - 18.4 ) .\
CONCLUSIONS	Early iNO therapy for hypoxic respiratory failure in term and near-term infants is not associated with an increase in neurodevelopmental impairment or hearing loss at 18 to 24 months postnatal age .\
\
###22114200\
BACKGROUND	Impaired balance has a significant negative impact on mobility , functional independence , and fall risk in older adults .\
BACKGROUND	Although several , well-respected balance measures are currently in use , there is limited evidence regarding the most appropriate measure to assess change in community-dwelling older adults .\
OBJECTIVE	The aim of this study was to compare floor and ceiling effects , sensitivity to change , and responsiveness across the following balance measures in community-dwelling elderly people with functional limitations : Berg Balance Scale ( BBS ) , Performance-Oriented Mobility Assessment total scale ( POMA-T ) , POMA balance subscale ( POMA-B ) , and Dynamic Gait Index ( DGI ) .\
METHODS	Retrospective data from a 16-week exercise trial were used .\
METHODS	Secondary analyses were conducted on the total sample and by subgroups of baseline functional limitation or baseline balance scores .\
METHODS	Participants were 111 community-dwelling older adults 65 years of age or older , with functional limitations .\
METHODS	Sensitivity to change was assessed using effect size , standardized response mean , and paired t tests .\
METHODS	Responsiveness was assessed using minimally important difference ( MID ) estimates .\
RESULTS	No floor effects were noted .\
RESULTS	Ceiling effects were observed on all measures , including in people with moderate to severe functional limitations .\
RESULTS	The POMA-T , POMA-B , and DGI showed significantly larger ceiling effects compared with the BBS .\
RESULTS	All measures had low sensitivity to change in total sample analyses .\
RESULTS	Subgroup analyses revealed significantly better sensitivity to change in people with lower compared with higher baseline balance scores .\
RESULTS	Although both the total sample and lower baseline balance subgroups showed statistically significant improvement from baseline to 16 weeks on all measures , only the lower balance subgroup showed change scores that consistently exceeded corresponding MID estimates .\
CONCLUSIONS	This study was limited to comparing 4 measures of balance , and anchor-based methods for assessing MID could not be reported .\
CONCLUSIONS	Important limitations , including ceiling effects and relatively low sensitivity to change and responsiveness , were noted across all balance measures , highlighting their limited utility across the full spectrum of the community-dwelling elderly population .\
CONCLUSIONS	New , more challenging measures are needed for better discrimination of balance ability in community-dwelling elderly people at higher functional levels .\
\
###12577155\
OBJECTIVE	Many patients have an unpleasant recollection of routine endotracheal suctioning after discharge from the Intensive Care Unit ( ICU ) .\
OBJECTIVE	We hypothesized that through minimally invasive airway suctioning discomfort and stress may be prevented , resulting in less recollection .\
METHODS	A prospective randomized clinical trial .\
METHODS	Two ICUs at the University Hospital of Groningen , the Netherlands .\
METHODS	Adult patients with an intubation period exceeding 24 h were included .\
METHODS	Patients received either routine endotracheal suctioning ( RES ) or minimally invasive airway suctioning ( MIAS ) during the duration of intubation .\
RESULTS	Within 3 days after ICU discharge all patients were interviewed , regarding recollection and discomfort of suctioning .\
RESULTS	The level of discomfort was quantified on a visual analogue scale ( VAS ) .\
RESULTS	We analyzed data from 208 patients ( RES : n = 113 , and MIAS : n = 95 ) .\
RESULTS	A significantly lower prevalence of recollection of airway suctioning was found in the MIAS group ( 20 % ) compared to the RES group ( 41 % ) ( P-value = 0.001 ) .\
RESULTS	No significant difference in level of discomfort was found between the RES and the MIAS group ( P-value = 0.136 ) .\
CONCLUSIONS	Minimally invasive airway suctioning results in a lower prevalence of recollection of airway suction than in RES , but not in discomfort .\
\
###11227171\
OBJECTIVE	To evaluate the effect of treatment with intravenous essentiale phospholipids in patients with liver cirrhosis and hepatic encephalopathy grade III-IV .\
METHODS	12 patients with hepatic encephalopathy grade III-IV due to decompensated liver cirrhosis , age 35-67 years , were randomized to two groups : Essentiale 2.0 g i.v. daily was given to 6 patients in combination with standard therapy for 2 weeks ; 6 patients had only standard therapy .\
METHODS	The patients were followed up for 90 days .\
METHODS	The diagnosis of hepatic encephalopathy was based on clinical examination , psychometrical tests and neurophysiological examination-EEG and evoked potentials .\
RESULTS	Mean survival in the group treated with Essentiale i.v. was 50.3 days in comparison to 34.7 days in control group .\
RESULTS	P300 latencies improved significantly in the Essentiale group in comparison to control group ( 427.5 ms before vs 366.3 ms after treatment period in the treated group ; 346.6 ms before vs 347.5 ms after treatment period in controls ) .\
RESULTS	Ammonia level decreased form 95 mumol/l .\
RESULTS	5 to 49.7 mumol/l in the treated group , while in controls remained unchanged ( 46.5 mumol/l before vs 53.5 mumol/l after treatment period ) .\
RESULTS	No adverse reactions were observed during the treatment with Essentiale i.v.\
CONCLUSIONS	Administration of Essentiale i.v. is a safe treatment of advanced liver disease .\
CONCLUSIONS	In the group of patients treated with Essentiale i.v. was observed prolonged survival , as an improvement of hepatic encephalopathy in comparison to control group .\
\
###15268690\
OBJECTIVE	To determine the effects of injection volume and vertebral anatomy on the spread of new methylene blue ( NMB ) injected into the lumbosacral epidural space in cats .\
METHODS	Prospective experimental study .\
METHODS	Sixteen cats .\
METHODS	Cats were randomly assigned to four groups and received from 0.1 to 0.4 mL kg ( -1 ) of 0.12 % NMB in 0.9 % saline .\
METHODS	Injection was made into the lumbosacral epidural space using a dorsal approach with the cats in sternal recumbency .\
METHODS	The extent of cranial migration of the dye as indicated by the staining of epidural fat and dura mater was measured .\
RESULTS	The mean + / - SD ( range ) number of stained vertebrae in the 0.3 and 0.4 mL kg ( -1 ) groups , were 11.5 + / - 1.5 ( T7-T11 ) and 12.4 + / - 1.8 ( T6-T10 ) , respectively .\
RESULTS	This was significantly greater than the number in the 0.1 and 0.2 mL kg ( -1 ) groups , 4.3 + / - 0.6 ( L3-L4 ) and 6.0 + / - 0.7 ( L1-L2 ) vertebrae , respectively ( p < 0.001 ) .\
RESULTS	Linear regression analysis showed that the volume injected correlated significantly with the number of stained vertebrae ( R2 = 0.83 , p < 0.001 ) .\
RESULTS	In the dorsal and lateral aspect of the spinal cord , NMB solution distributed between epidural fat and dura mater .\
RESULTS	Migration under the spinal cord occurred along the two longitudinal epidural veins .\
CONCLUSIONS	The larger the volume of solution injected into the lumbosacral epidural space in cats , the greater the spread .\
\
###19912686\
OBJECTIVE	To evaluate the efficacy and safety of 96 weeks adefovir dipivoxil ( ADV ) treatment for chronic hepatitis patients with cirrhosis in their decompensation period .\
METHODS	Chronic hepatitis patients with cirrhosis in their decompensation period were randomly divided into two groups .\
METHODS	An ADV group : patients treated with 10 mg ADV per day ; a lamivudine ( LMV ) group : patients treated with 100mg LMV per day .\
METHODS	The course of treatment lasted 96 weeks .\
METHODS	Serum levels of ALT , AST , Alb , Tbil , HbeAg , HBV DNA , PCIII , IVC , LN and HA , renal function , Child-Pugh scores , drug adverse reactions and complication during the treatment of the two groups were analyzed .\
RESULTS	During the two-year treatment , the proportions of patients with a return to normal liver function were similar in both groups .\
RESULTS	With the treatment prolonged , serum HBV DNA levels of the patients in adefovir dipivoxil group decreased gradually .\
RESULTS	The HBV DNA level in some lamivudine-treated patients was increased .\
RESULTS	The sero-conversion rate of HBeAg/HBeAb of the patients in the two groups was increased with the prolongation of the treatment .\
RESULTS	At 96 weeks , the ratio of emerging virus-resistant strains was lower in the adefovir dipivoxil group than in the lamivudine group .\
RESULTS	The levels of the serum markers of hepatic fibrosis of the patients in the two groups remained low .\
RESULTS	Child-Pugh scores of the patients in the two groups were significantly improved .\
RESULTS	No significant difference in the total incidence of complications between the two groups was noticed .\
RESULTS	Each of the two groups had a patient with liver-kidney syndrome and other serious complications .\
CONCLUSIONS	The efficacy and safety of adefovir dipivoxil and lamivudine treatment for the above patients are similar , but the ratio of emerging virus-resistant strains of the adefovir dipivoxil treatment group is lower than that of lamivudine treatment group .\
\
###12182252\
BACKGROUND	Rosiglitazone is an insulin-sensitizing oral agent in the thiazolidinedione class used to treat patients with type 2 diabetes mellitus .\
BACKGROUND	It binds to peroxisome proliferator-activated receptor gamma in liver , muscle , and adipose tissue .\
BACKGROUND	Ranitidine , a histamine2-receptor antagonist , may be prescribed for patients with type 2 diabetes and esophageal symptoms such as heartburn .\
BACKGROUND	By raising gastrointestinal pH levels , ranitidine may affect the bioavailability of coadministered drugs .\
OBJECTIVE	This article presents the absolute bioavailability of rosiglitazone , as well as the effects of ranitidine on the pharmacokinetics of rosiglitazone .\
METHODS	Healthy men were enrolled in a randomized , open-label , 4-period , period-balanced crossover study of rosiglitazone and ranitidine .\
METHODS	All individuals received each of 4 regimens successively , separated by a 4-day washout period : a single IV dose of rosiglitazone 2 mg administered alone over 1 hour ; a single IV dose of rosiglitazone 2 mg administered over 1 hour on the fourth day of treatment with oral ranitidine 150 mg given every 12 hours ; a single oral dose of rosiglitazone 4 mg alone ; and a single oral dose of rosiglitazone 4 mg on the fourth day of treatment with oral ranitidine 150 mg given every 12 hours .\
METHODS	The primary end point was dose-normalized area under the plasma concentration-time curve from time 0 to infinity ( AUC ( 0-infinity ) ) .\
METHODS	Maximum observed plasma concentration ( Cmax ) , the time at which Cmax occurred ( Tmax ) , plasma clearance ( CL ) , steady-state volume of distribution ( Vss ) , and terminal elimination half-life ( t 1/2 ) were also assessed .\
RESULTS	Twelve individuals were enrolled .\
RESULTS	The absolute bioavailability of rosiglitazone was 99 % .\
RESULTS	For AUC ( 0-infinity ) , the point estimate and the associated 95 % CI for the ratio of ranitidine + IV rosiglitazone to IV rosiglitazone alone was 1.02 ( range , 0.88-1 .20 ) .\
RESULTS	With oral rosiglitazone , the AUC ( 0-infinity ) point estimate ( 95 % CI ) for the ratio of ranitidine + rosiglitazone to rosiglitazone alone was 0.99 ( range , 0.85-1 .16 ) .\
RESULTS	Cmax , Tmax , t 1/2 , Vss and CL of rosiglitazone , whether administered orally or intravenously , were unaffected by ranitidine .\
RESULTS	Oral and IV rosiglitazone were associated with a favorable safety profile and were well tolerated with or without concurrent ranitidine treatment .\
CONCLUSIONS	In this study of 12 healthy adult male volunteers , the absolute bioavailability of rosiglitazone was 99 % , and the oral and IV single-dose pharmacokinetics of rosiglitazone were unaltered by concurrent treatment with ranitidine .\
\
###15367189\
OBJECTIVE	This randomized clinical trial was aimed at comparing two different means of delivering chlorhexidine digluconate ( CHX ) for plaque control during the 2 weeks following implant surgery .\
METHODS	Twenty patients selected for implant therapy were randomly divided into two groups : 10 subjects used 15 ml of 0.12 % CHX mouthrinse ( control group ) and 10 used 0.2 % CHX spray ( test group ) .\
METHODS	Professional oral hygiene was carried out immediately before surgery .\
METHODS	During the 14 days following surgery mechanical oral hygiene was performed only at the teeth not surgically involved .\
METHODS	Plaque index ( PI ) , stain index ( SI ) , modified gingival index and taste alteration were assessed on the 7th and 14th day after surgery .\
METHODS	The clinical parameters were evaluated at four tooth surfaces by a single examiner .\
METHODS	Teeth proximal to surgical site and teeth not involved were statistically compared .\
RESULTS	In both groups , the PI increased similarly , with respect to the baseline , at days 7 and 14 .\
RESULTS	There was no significant difference between the two groups at either time point .\
RESULTS	On the contrary , in the control group , the SI increased significantly when compared with baseline over the 14 days both at teeth nearest to surgical sites and at not-involved sites .\
RESULTS	In the test group pigmentation was consistent only at teeth proximal to the surgical site .\
RESULTS	When considering not-involved sites , tooth staining was significantly lower in the test with respect to the control group .\
CONCLUSIONS	The present study indicates that the efficacy of CHX spray in the post-surgical control of dental plaque is similar to that of CHX mouthwash .\
CONCLUSIONS	Tooth staining , however , is significantly lower in the spray group at sites not surgically involved .\
CONCLUSIONS	These effects might be related to the route of CHX delivery , as well as the total dose administered that was significantly lower in the spray group with respect to the rinse group .\
\
###18063204\
OBJECTIVE	To evaluate the impact of interpleural analgesia ( IP ) on postthoracotomy pain and respiratory function as an alternative to thoracic epidural analgesia ( TEA ) .\
METHODS	Prospective , randomized study .\
METHODS	Tertiary-care military hospital .\
METHODS	Sixty young patients scheduled for elective thoracic surgery ( correction of aorta coarctation and patent ductus arteriosus ) .\
METHODS	Patients were randomized into two groups to receive either IP or TEA for postthoracotomy pain management .\
METHODS	Patients in the IP group ( n = 30 ) had a catheter inserted between the parietal and visceral pleura by a surgeon , and 0.2 % ropivacaine was given through this catheter .\
METHODS	In the TEA group , ropivacaine was administered through a thoracic epidural catheter .\
METHODS	The impact of both methods on pain control , respiratory function , and pulmonary complications was analyzed and compared .\
RESULTS	The frequency of atelectasis and pleural effusion was also significantly high in the IP group ( P < 0.01 ) .\
RESULTS	Respiratory function and postoperative pain scores were better in the TEA group ( P < 0.01 ) .\
RESULTS	Arterial blood gas analysis on the fifth postoperative day was significantly better in the TEA group .\
CONCLUSIONS	Thoracic epidural analgesia has more beneficial effects on respiratory function and postoperative pain after thoracotomy than does IP .\
\
###21969930\
BACKGROUND	Noneosinophilic asthma has been regarded as a distinct phenotype characterized by a poor response to inhaled corticosteroids ( ICS ) .\
OBJECTIVE	To determine whether noneosinophilic , steroid-naive asthmatic subjects show an improvement in asthma control , asthma symptoms and spirometry after four weeks of treatment with ICS , and whether they further benefit from the addition of a long-acting beta-2 agonists to ICS .\
METHODS	A randomized , double-blind , placebo-controlled , multicentre study comparing the efficacy of placebo versus inhaled fluticasone propionate 250 mcg twice daily for four weeks in mildly uncontrolled , steroid-naive asthmatic subjects with a sputum eosinophil count of 2 % or less .\
METHODS	This was followed by an open-label , four-week treatment period with fluticasone propionate 250 mcgsalmeterol 50 mcg , twice daily for all subjects .\
RESULTS	After four weeks of double-blind treatment , there was a statistically significant and clinically relevant improvement in the mean ( SD ) Asthma Control Questionnaire score in the ICS-treated group ( n = 6 ) ( decrease of 1.0 0.5 ) compared with the placebo group ( n = 6 ) ( decrease of 0.09 0.4 ) ( P = 0.008 ) .\
RESULTS	Forced expiratory volume in 1 s declined in the placebo group ( -0.2 0.2 L ) and did not change in the ICS group ( 0.04 0.1 L ) after four weeks of treatment ( P = 0.02 ) .\
RESULTS	The open-label treatment with fluticasone propionate 250 mcgsalmeterol 50 mcg did not produce additional improvements in those who were previously treated for four weeks with inhaled fluticasone alone .\
CONCLUSIONS	A clinically important and statistically significant response to ICS was observed in mildly uncontrolled noneosinophilic asthmatic subjects .\
\
###17244295\
OBJECTIVE	To assess the effects of Cash and Counseling on Medicaid beneficiaries ' primary informal caregivers and describe the experiences of their directly hired workers .\
METHODS	Beneficiaries in Arkansas , Florida , and New Jersey voluntarily enrolled in the demonstration and were randomly assigned to direct their own Medicaid supportive services as Cash and Counseling consumers ( the treatment group ) or to rely on Medicaid services as usual ( the control group ) .\
METHODS	Beneficiaries identified their primary informal caregiver during a baseline interview and their primary paid worker during a 9-month follow-up interview .\
METHODS	Data were collected through telephone interviews with caregivers and workers .\
METHODS	These interviews were conducted about 10 months after beneficiaries ' random assignment , between February 2000 and May 2003 , depending on the state .\
METHODS	DATA ANALYSIS METHODS : We estimated program effects with regression and logit models and compared the mean characteristics of directly hired workers and agency workers , by state .\
RESULTS	Compared with caregivers in the control group , those in the treatment group had modestly to substantially better outcomes for measures of satisfaction with care , worry , and physical and financial strain .\
RESULTS	For hours of care and emotional strain , outcomes in the treatment group were similar to or somewhat better than those in the control group .\
RESULTS	Directly hired workers reported greater satisfaction with wages , similar satisfaction with working conditions , and similar rates of injuries as agency workers .\
RESULTS	Workers who were related to the beneficiary reported more emotional strain than agency workers .\
CONCLUSIONS	Cash and Counseling can lessen some of the burden associated with caring for a child or adult with disabilities .\
CONCLUSIONS	The experiences of hired workers suggest consumer direction is a sustainable option , but support networks for workers might be a welcome program improvement .\
\
###11844850\
BACKGROUND	In patients with decreased resistance to infection , Staphylococcus aureus is a major cause of bacteremia and its complications .\
BACKGROUND	The capsular polysaccharides are essential for the pathogenesis of and immunity to S. aureus infection and are targets for vaccines .\
METHODS	In a double-blind trial involving patients with end-stage renal disease who were receiving hemodialysis , we evaluated the safety , immunogenicity , and efficacy of a vaccine with S. aureus type 5 and 8 capsular polysaccharides conjugated to nontoxic recombinant Pseudomonas aeruginosa exotoxin A. Between April 1998 and August 1999 , 1804 adult patients at 73 hemodialysis centers were randomly assigned to receive a single intramuscular injection of either vaccine or saline .\
METHODS	IgG antibodies to S. aureus type 5 and 8 capsular polysaccharides were measured for up to two years , and episodes of S. aureus bacteremia were recorded .\
METHODS	Efficacy was estimated by comparing the incidence of S. aureus bacteremia in the patients who received the vaccine with the incidence in the control patients .\
RESULTS	Reactions to the vaccine were generally mild to moderate , and most resolved within two days .\
RESULTS	The capsular polysaccharides elicited an antibody response of at least 80 microg per milliliter ( the estimated minimal level conferring protection ) in 80 percent of patients for type 5 and in 75 percent of patients for type 8 .\
RESULTS	The efficacy during weeks 3 to 54 was only 26 percent ( P = 0.23 ) .\
RESULTS	However , between weeks 3 and 40 after vaccination , S. aureus bacteremia developed in 11 of 892 patients in the vaccine group who could be evaluated for bacteremia , as compared with 26 of 906 patients in the control group ( estimate of efficacy , 57 percent ; 95 percent confidence interval , 10 to 81 percent ; nominal P = 0.02 ) .\
CONCLUSIONS	In patients receiving hemodialysis , a conjugate vaccine can confer partial immunity against S. aureus bacteremia for approximately 40 weeks , after which protection wanes as antibody levels decrease .\
\
###14530679\
OBJECTIVE	Hemorrhoidectomy is frequently associated with significant postoperative pain , and new techniques to reduce this pain are constantly under evaluation .\
OBJECTIVE	The present study was conducted to determine the usefulness of the Ligasure system and compare it with conventional diathermy for hemorrhoidectomy .\
METHODS	Thirty-four consecutive patients with Grade 3 or 4 hemorrhoids requiring surgery were recruited and randomized into two groups by preoperative assignment of sealed envelopes .\
METHODS	Patients with coexisting perianal disease , previous perianal surgery , or thrombosed hemorrhoids were excluded .\
METHODS	All patients were anesthetized and operated on by a single team .\
METHODS	In one group , monopolar diathermy in the coagulation mode was used to dissect hemorrhoidal tissue from the internal sphincter .\
METHODS	In the second group , tissue was coagulated by Ligasure and then divided with scissors .\
METHODS	Operating time was documented by theater staff .\
METHODS	Postoperatively , pain scores and Cleveland Clinic incontinence scores were documented .\
RESULTS	Seventeen patients were randomized into each group .\
RESULTS	There were no significant differences in age , gender , or clinical symptoms between the groups .\
RESULTS	The mean operating time in the Ligasure group was 6 ( range , 4-10 ) minutes compared with 11 ( range , 7-20 ) minutes in the other group , and this was statistically significant ( P < 0.001 ) .\
RESULTS	Patients in the Ligasure group reported significantly less pain with first defecation and at postoperative Days 1 and 14 ( P < 0.001 ) .\
RESULTS	The mean hospital stay in both groups was one ( range , 1-5 ) day , and there was no difference in the incontinence scores .\
CONCLUSIONS	Ligasure diathermy provides a superior alternative to conventional diathermy in hemorrhoidectomy by reducing operating time and postoperative pain .\
\
###20810311\
OBJECTIVE	Although many animal and human studies have been performed , the exact mechanisms of action whereby modafinil promotes wakefulness are still not completely understood .\
OBJECTIVE	We aimed to investigate the functional effects of modafinil on motor cortex excitability in patients with narcolepsy by means of transcranial magnetic stimulation ( TMS ) techniques .\
METHODS	In a double-blind and placebo-controlled design , 24 drug-naive narcoleptic patients with cataplexy and 20 control subjects were administered modafinil or placebo over a period of 4 weeks .\
METHODS	TMS was performed twice during the awake state before and at the end of treatment ; measures of cortical excitability included central motor conduction time , resting motor threshold , short latency intracortical inhibition ( SICI ) and intracortical facilitation to paired-TMS .\
METHODS	TMS measures were correlated with the conventional neurophysiological method of Multiple Sleep Latency Test ( MSLT ) and the subjective Epworth Sleepiness Scale ( ESS ) .\
RESULTS	As previously reported , motor threshold and SICI were significantly increased in patients with narcolepsy ; modafinil reversed this cortical hypoexcitability , but only SICI differences reached statistical significance .\
RESULTS	The Spearman rank correlation analysis revealed the highest correlation between SICI and the MSLT ; a positive correlation was also found between SICI and the ESS , as well as between RMT and both measures of daytime sleepiness .\
CONCLUSIONS	This represents the first report investigating effects of modafinil on cortical excitability in human narcolepsy .\
CONCLUSIONS	Since SICI is thought to be directly related to GABA ( A ) intracortical inhibitory activity , we demonstrated that the dose of modafinil that induces a satisfactory wakefulness-promoting response in narcoleptic patients also causes decrease in GABAergic transmission .\
\
###22168530\
BACKGROUND	Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals .\
BACKGROUND	Effective patient self-management is critical for improving health outcomes .\
BACKGROUND	However , key aspects of self-management such as self-monitoring of behaviours and symptoms , coupled with regular feedback from the health care team , are rarely addressed or integrated into ongoing care .\
BACKGROUND	Health information technology ( HIT ) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team , and access to their health information , presented in personalized ways that can alert them when there is a need for action .\
BACKGROUND	The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system , My Asthma Portal ( MAP ) , linked to a case-management system on asthma control , and asthma health-related quality of life .\
METHODS	The trial is a parallel multi-centered 2-arm pilot randomized controlled trial .\
METHODS	Participants are randomly assigned to one of two conditions : a ) MAP and usual care ; or b ) usual care alone .\
METHODS	Individuals will be included if they are between 18 and 70 , have a confirmed asthma diagnosis , and their asthma is classified as not well controlled by their physician .\
METHODS	Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database , and asthma quality of life using the Mini Asthma Related Quality of Life Questionnaire .\
METHODS	Power calculations indicated a needed total sample size of 80 subjects .\
METHODS	Data are collected at baseline , 3 , 6 , and 9 months post randomization .\
METHODS	Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010 .\
CONCLUSIONS	Self-management support from the care team is critical for improving chronic disease outcomes .\
CONCLUSIONS	Given the high volume of patients and time constraints during clinical visits , primary care physicians have limited time to teach and reinforce use of proven self-management strategies .\
CONCLUSIONS	HIT has the potential to provide clinicians and a large number of patients with tools to support health behaviour change .\
BACKGROUND	Current Controlled Trials ISRCTN34326236 .\
\
###15208157\
OBJECTIVE	Catecholamines ( CA ) inhibit leptin secretion .\
OBJECTIVE	Alcohol appears to have a similar effect .\
OBJECTIVE	The mechanism underlying the inhibitory effect of alcohol is unknown , but CA may play a role as mediators .\
OBJECTIVE	This hypothesis has never been tested .\
OBJECTIVE	We decided to do so in the present investigation .\
METHODS	Seven healthy subjects participated in two experiments ( A and B ) , performed in random order , 1 week apart .\
METHODS	In experiment A , three identical doses of ethanol ( 0.45 g/kg b.w. ) were ingested at regular intervals between 09:00 and 12:00 hours .\
METHODS	The alcohol doses were given against a background of oral placebo administered at 08:00 and 12:00 hours .\
METHODS	In experiment B , identical doses of alcohol were ingested against a background of oral propranolol ( 40 mg at 08:00 and 20 mg at 12:00 hours ) .\
METHODS	Pulse rates , and serum levels of ethanol , insulin , IGF-1 and leptin , were determined at regular intervals throughout the experiments .\
METHODS	Urinary CA excretion was also determined .\
RESULTS	Propranolol ( experiment B ) decreased the pulse rate significantly , compared with placebo ( experiment A ) , but did not change the urinary excretion of adrenaline nor noradrenaline .\
RESULTS	Alcohol ingestion raised the serum ethanol levels similarly in the two experiments but did not affect the insulin or IGF-1 levels .\
RESULTS	The serum leptin levels declined similarly in the two experiments , as evidenced by the percentage serum leptin decline from baseline , which was 28.6 + / - 5.4 % in experiment A and 29.0 + / - 2.9 % in experiment B.\
CONCLUSIONS	The declining serum leptin concentration after acute ingestion of alcohol does neither appear to be CA-mediated nor to be caused by changed secretion of insulin or IGF-1 .\
CONCLUSIONS	A direct inhibitory effect of alcohol on the adipocytes is possible , but increased disposal of leptin via hepatic metabolism or renal excretion could also contribute .\
\
###20588090\
OBJECTIVE	The purpose of this study was to determine whether the addition of gaze stability exercises to balance rehabilitation would lead to greater improvements of symptoms and postural stability in older adults with normal vestibular function who reported dizziness .\
METHODS	Participants who were referred to outpatient physical therapy for dizziness were randomly assigned to the gaze stabilization ( GS ) group ( n = 20 ) or control ( CON ) group ( n = 19 ) .\
METHODS	Dizziness was defined as symptoms of unsteadiness , spinning , a sense of movement , or lightheadedness .\
METHODS	Participants were evaluated at baseline and discharge on symptoms , balance confidence , visual acuity during head movement , balance , and gait measures .\
METHODS	The GS group performed vestibular adaptation and substitution exercises designed to improve gaze stability , and the CON group performed placebo eye exercises designed to be vestibular neutral .\
METHODS	In addition , both groups performed balance and gait exercises .\
RESULTS	There were no baseline differences ( P > .05 ) between the GS and CON groups in age , sex , affect , physical activity level , or any outcome measures .\
RESULTS	Both groups improved significantly in all outcome measures with the exception of perceived disequilibrium .\
RESULTS	However , there was a significant interaction for fall risk as measured by Dynamic Gait Index ( P = .026 ) such that the GS group demonstrated a significantly greater reduction in fall risk compared with the CON group ( 90 % of the GS group demonstrated a clinically significant improvement in fall risk versus 50 % of the CON group ) .\
CONCLUSIONS	This study provides evidence that in older adults with symptoms of dizziness and no documented vestibular deficits , the addition of vestibular-specific gaze stability exercises to standard balance rehabilitation results in greater reduction in fall risk .\
\
###23401294\
BACKGROUND	Hyperkyphosis increases the risk of falls for elderly people by reducing postural balance .\
BACKGROUND	Spinomed orthosis and the posture-training support are two available options for improving postural balance but have never been compared .\
OBJECTIVE	To compare the effect of the Spinomed orthosis and the posture-training support on balance in elderly people with thoracic hyperkyphosis .\
METHODS	This study is a clinical trial on an accessible sample of elderly people with thoracic kyphosis .\
METHODS	Eighteen participants ( 16 women and 2 men ) , aged 60-80 years , with thoracic kyphosis greater than 50 , completed the study procedure .\
METHODS	Subjects were randomly allocated to two groups , namely , Spinomed orthosis and the posture-training support groups .\
METHODS	Sensory organization test and limits of stability were assessed using the EquiTest system and the Balance Master system , respectively .\
METHODS	Balance score , directional control , and reaction time were measured to evaluate balance with and without orthosis in a random order .\
RESULTS	In the posture-training support group , significant changes were observed in the studied balance parameters : balance score ( p < 0.001 ) , directional control ( p = 0.027 ) , and reaction time ( p = 0.047 ) .\
RESULTS	There was a significant change in balance score ( p < 0.001 ) and directional control ( p = 0.032 ) in the Spinomed group .\
RESULTS	However , there were no significant differences in the effect of the two orthoses , the Spinomed orthosis and posture-training support , on balance factors .\
CONCLUSIONS	Both Spinomed orthosis and posture-training support may improve balance in the elderly with thoracic hyperkyphosis in a similar manner .\
\
###14677619\
OBJECTIVE	This open-label , non-comparative study was conducted at a single center to evaluate the effects on the endometrium of a 24-day regimen of a combined oral contraceptive containing gestodene ( GTD ) 60 microg and ethinylestradiol ( EE ) 15 microg .\
METHODS	Healthy parous women who were > or = 18 years old and had had regular menstrual cycles for the prior 3 months were randomly assigned to one of two groups .\
METHODS	Subjects in group A underwent endometrial biopsies during the late luteal phase of the pretreatment cycle and between days 15 and 24 of cycle 6 .\
METHODS	Subjects in group B had biopsies between days 15 and 24 of cycle 3 and during the late luteal phase of the post-treatment cycle .\
METHODS	GTD 60 microg/EE 15 microg was taken for the first 24 days of a 28-day cycle , followed by placebo pills for 4 days , for a total of six cycles .\
RESULTS	Data from 27 women were included in the analyses .\
RESULTS	Eleven of the 13 evaluable baseline biopsies were classified as secretory .\
RESULTS	Three of nine subjects with evaluable biopsies at cycle 3 and four of nine subjects with evaluable biopsies at cycle 6 had an atrophic endometrium .\
RESULTS	Post-treatment biopsies showed a typical secretory endometrium in seven of 11 subjects with evaluable biopsies .\
CONCLUSIONS	The results of this study show that the 24-day regimen of GTD 60 microg/EE 15 microg produced effective endometrial suppression .\
\
###16127467\
OBJECTIVE	The objective of this study was to compare the plaque removal efficacy of a prototype manual Deep Clean toothbrush versus an American Dental Association ( ADA ) manual toothbrush and the ADA manual toothbrush in conjunction with floss .\
METHODS	This study was a randomized , examiner-blind , six-period cross-over , single-center study conducted in 60 adult subjects that examined plaque removal with a prototype Deep Clean manual toothbrush , an ADA reference manual toothbrush , and an ADA reference manual toothbrush followed by floss .\
METHODS	During the course of this study , subjects used each treatment two times .\
METHODS	Plaque was scored before and after brushing using the Rustogi Modification of the Navy Plaque Index .\
METHODS	A mixed model analysis of covariance ( ANCOVA ) for a crossover design with baseline plaque score as the covariate was applied to the baseline minus one-minute post-brushing differences in average whole-mouth plaque scores .\
METHODS	Supplemental analyses were also performed using the ANCOVA model separately for average gingival margin scores and for average interproximal scores , using the appropriate baseline score as the covariate .\
METHODS	All comparisons were two-sided at the 0.05 level of significance .\
RESULTS	The prototype Deep Clean manual toothbrush delivered an adjusted ( via ANCOVA ) mean difference between baseline and post-brushing plaque scores of 0.245 , while the ADA manual toothbrush plus floss delivered an adjusted mean difference of 0.207 versus 0.196 for the ADA manual toothbrush alone .\
RESULTS	The prototype Deep Clean manual toothbrush demonstrated a statistically significantly greater reduction in plaque than the ADA manual toothbrush plus floss ( p < 0.001 ) , which in turn had a statistically significantly greater reduction in plaque than the ADA manual toothbrush alone ( p < 0.001 ) .\
RESULTS	The prototype Deep Clean manual toothbrush group had , on average , 25.2 % and 18.3 % greater plaque removal scores than the ADA manual toothbrush alone and the ADA manual toothbrush plus floss groups , respectively .\
RESULTS	Results for the interproximal and gingival margin regions also demonstrated statistically significantly ( p < 0.001 ) greater plaque removal for the prototype Deep Clean manual toothbrush group relative to the other groups .\
CONCLUSIONS	The prototype manual Deep Clean toothbrush was found to deliver greater plaque removal by 25.2 % and 18.3 % compared to the control manual toothbrush group ( ADA reference manual toothbrush ) and ADA manual toothbrush plus floss group .\
\
###18577834\
BACKGROUND	Pioglitazone added to successful statin therapy may be beneficial for coronary artery disease ( CAD ) patients without diabetes mellitus .\
RESULTS	Fourteen individuals optimally treated with statin for > 6 months were randomized to a pioglitazone or control group .\
RESULTS	Pioglitazone significantly improved insulin resistance , reduced high-sensitivity C-reactive protein , increased high-molecular-weight adiponectin and high-density lipoprotein cholesterol levels .\
RESULTS	Ultrasound echogenicity of carotid atheroma assessed by integrated backscatter was significantly increased by pioglitazone and correlated with adiponectin levels .\
CONCLUSIONS	Adding pioglitazone to successful statin therapy may be an effective therapeutic strategy for patients with CAD .\
\
###1860199\
BACKGROUND	Among survivors of acute myocardial infarction , frequent and repetitive ventricular premature depolarizations ( VPDs ) detected on ambulatory monitoring contribute independently to the risk of all-cause mortality and sudden death .\
BACKGROUND	Apart from the beta-blockers , no antiarrhythmic drug has been reliably demonstrated to reduce mortality among patients with VPDs .\
BACKGROUND	A pilot study was undertaken to gather data to aid in the design of a multicenter trial of amiodarone for the reduction of mortality from cardiac arrhythmias in such patients .\
RESULTS	Seventy-seven patients with acute myocardial infarction within the previous 6-30 days and 10 or more VPDs/hr or one or more runs of ventricular tachycardia on 24-hour electrocardiographic recording were randomized in a double-blind fashion in a 2:1 amiodarone-to-placebo ratio .\
RESULTS	The loading dose was 10 mg/kg/day for 3 weeks .\
RESULTS	The maintenance dose was 300-400 mg/day with reductions at 4-month intervals in response to VPD suppression , excessive plasma levels , or toxicity .\
RESULTS	VPD suppression at 1 week and 2 weeks was 63 % and 85 % , respectively , on amiodarone and 17 % and 27 % , respectively , on placebo .\
RESULTS	Apart from thyroid-stimulating hormone elevation and skin reactions , no side effects occurred more frequently with amiodarone .\
RESULTS	The study drug was stopped for side effects or noncompliance in 35 % of amiodarone patients and 34 % of placebo patients .\
RESULTS	Patients were followed for a maximum of 2 years ( mean , 20 months ) .\
RESULTS	Arrhythmic death or resuscitated ventricular fibrillation occurred in two of 48 amiodarone patients ( 6 % ) and four of 29 placebo patients ( 14 % ) , whereas the rates of all-cause mortality were five of 48 ( 10 % ) and six of 29 ( 21 % ) , respectively .\
CONCLUSIONS	Amiodarone , in moderate loading and maintenance dosages with adjustments in response to plasma levels , VPD suppression , and side effects , results in effective VPD suppression and acceptable levels of toxicity .\
\
###12241656\
BACKGROUND	The role of pulsed dye lasers ( PDL ) in the treatment of childhood haemangiomas is controversial .\
BACKGROUND	Our aim was to compare treatment with PDL with a wait-and-see policy .\
METHODS	We did a prospective , randomised controlled trial in which we enrolled 121 infants aged 1-14 weeks with early haemangiomas .\
METHODS	We assigned infants to PDL treatment ( n = 60 ) or observation ( n = 61 ) , and followed them up to age 1 year .\
METHODS	The main outcome measures assessed were proportion of lesions completely clear or with minimum residual signs , adverse reactions , including pigmentary disturbance and skin atrophy , complications such as ulceration and infection , proportion of children whose parents considered the haemangioma a problem , characteristics of the haemangioma , and an independent assessment of the haemangioma problem by a panel of five parents .\
METHODS	Analysis was by intention to treat .\
RESULTS	All infants completed the study .\
RESULTS	The number of children whose lesions showed complete clearance or minimum residual signs at 1 year was not significantly different in the PDL treated and observation groups ( 25 , 42 % , vs 27 , 44 % ; p = 0.92 ) .\
RESULTS	However , PDL treated infants were more likely to have skin atrophy ( 17 , 28 % , vs 5 , 8 % ; p = 0.008 ) and hypopigmentation ( 27 , 45 % , vs 9 , 15 % ; p = 0.001 ) .\
RESULTS	The frequency of complications was similar between groups .\
RESULTS	The only objective measure of resolution that improved with PDL treatment was haemangioma redness .\
RESULTS	The number of children whose parents considered the haemangioma to be a problem at 1 year did not differ much between groups ( 11 of 60 , 18 % , vs 9 of 61 , 15 % ; p = 0.78 ) .\
RESULTS	The independent parent panel validated this result .\
CONCLUSIONS	PDL treatment in uncomplicated haemangiomas is no better than a wait-and-see policy .\
\
###16813179\
OBJECTIVE	To search for the best method for increasing clinical therapeutic effect on apoplectic hemiplegia .\
METHODS	One hundred and twenty cases of apoplectic hemiplegia were randomly divided into three groups in order of visiting .\
METHODS	Group A ( n = 33 ) were treated by scalp acupuncture combined with consciousness-restoring resuscitation method , group B ( n = 60 ) by scalp acupuncture combined with traditional acupuncture , and group C ( n = 27 ) by traditional acupuncture .\
METHODS	The clinical therapeutic effects were evaluated according to the scores of manner , speech , motor function of limbs , and so on .\
RESULTS	Three cases were basically cured , 20 were markedly effective , 7 were effective , with a total effective rate of 90.9 % in the group A ; and the corresponding figures were 7 , 28 , 21 cases and 93.3 % , respectively in group B with no significant difference between the group A and B ( P > 0.05 ) ; and 7 cases were markedly effective , 11 effective with a total effective rate of 66.7 % in the group C with a significant difference as compared with the group A and B ( P < 0.05 , P < 0.001 ) .\
CONCLUSIONS	Scalp acupuncture combined with consciousness-restoring resuscitation method and scalp acupuncture combined with traditional acupuncture have a similar therapeutic effect on apoplectic hemiplegia , which is superior to that of traditional acupuncture .\
\
###16085692\
BACKGROUND	PS-341 is a proteasome inhibitor with preclinical activity in pancreatic cancer tumor models and synergistic activity with gemcitabine .\
BACKGROUND	This randomized phase II study determined the tumor response rate ( RR ) for PS-341 alone and the 6-month survival and RR for the combination of gemcitabine and PS-341 in patients with metastatic pancreatic adenocarcinoma .\
METHODS	Patients were randomized to receive 3-week cycles of either arm A : PS-341 1.5 mg/m ( 2 ) i.v. bolus ( over 3 -- 5 s ) on days 1 , 4 , 8 and 11 or arm B : PS-341 1.0 mg/m ( 2 ) ( same as arm A otherwise ) plus gemcitabine 1,000 mg/m ( 2 ) i.v. on days 1 and 8 .\
METHODS	Patients progressing on arm A were allowed to receive arm B treatment .\
RESULTS	Arm A : 42 evaluable patients were enrolled with a confirmed RR of 0 % ( 95 % CI 0 % to 8 % ) , median survival of 2.5 months ( 95 % CI 2.0-3 .3 ) , and median time to progression ( TTP ) of 1.2 months ( 95 % CI 1.1 -- 1.3 ) .\
RESULTS	Twelve of 43 evaluable patients ( 28 % ) experienced at least one grade 4 + AE .\
RESULTS	Arm B : 39 evaluable patients yielded a 6-month survival rate of 41 % ( 16/39 , 95 % CI 29.8 % to 67.0 % ) , median survival of 4.8 months ( 95 % CI 2.4 -- 7.4 ) , median TTP of 2.4 months ( 95 % CI 1.5 -- 3.1 ) , and confirmed RR of 10 % ( 4 partial responses/0 complete responses , 95 % CI 3 % to 24 % ) .\
RESULTS	Eleven of 43 evaluable patients ( 26 % ) experienced at least one grade 4 + AE .\
RESULTS	One patient had grade 5 hypotension .\
CONCLUSIONS	The use of PS-341 alone or in combination with gemcitabine did not result in an overall survival and RR better than that expected for gemcitabine alone .\
CONCLUSIONS	Based on the lack of efficacy and the toxicity seen in our trial , there does not appear to be a role for PS-341 in pancreatic adenocarcinoma with either of the schedules used in this trial .\
\
###24493296\
OBJECTIVE	The preferred approach to the management of common bile duct ( CBD ) stones is uncertain , with single-stage laparoscopic cholecystectomy and CBD exploration vs. two-stage preoperative endoscopic CBD clearance followed by laparoscopic cholecystectomy being debated .\
OBJECTIVE	To address this , a prospective randomized study which compared these two management strategies was undertaken .\
METHODS	Between Jan 2002 and Dec 2005 , patients with gallstones and common bile duct stones diagnosed by preoperative ultrasonography and magnetic resonance cholangiopancreatography were randomized to single-stage vs. two-stage treatment .\
METHODS	In a single-stage group , laparoscopic cholecystectomy and CBD exploration were undertaken at the same operation , whereas in a two-stage group , endoscopic stone clearance was followed by laparoscopic cholecystectomy 2-5 days later .\
METHODS	Early treatment success and complications and longer-term follow-up for the two groups were compared .\
RESULTS	Two hundred twenty-one patients were enrolled in the trial , 110 in the single-stage group and 111 in the two-stage group .\
RESULTS	There was no significant difference in the success rate of CBD clearance ( 93.6 vs. 94.6 % , p = 0.76 ) or the complication rates ( 3.6 vs. 5.1 % , p = 0.527 ) between the groups .\
RESULTS	However , at longer-term follow-up , recurrent CBD stones were seen more often in the two-stage group ( 9.5 vs. 2.1 % , p = 0.037 ) .\
CONCLUSIONS	The single-stage and two-stage approaches were equally effective in achieving initial clearance of CBD stones .\
CONCLUSIONS	However , recurrent CBD stones occurred more commonly in patients who had undergone two-stage treatment with initial endoscopic stone clearance , followed by laparoscopic cholecystectomy .\
\
###12719501\
OBJECTIVE	This study examined the incremental cost-effectiveness of a collaborative care intervention for depression compared with consult-liaison care .\
METHODS	A total of 354 patients in a Department of Veterans Affairs ( VA ) primary care clinic who met the criteria for major depression or dysthymia were randomly assigned to one of the two care models .\
METHODS	Under the collaborative care model , a mental health team provided a treatment plan to primary care providers , telephoned patients to encourage adherence , reviewed treatment results , and suggested modifications .\
METHODS	Outcomes were assessed at three and nine months by telephone interviews .\
METHODS	Health care use and costs were also assessed .\
RESULTS	A significantly greater number of collaborative care patients were treated for depression and given prescriptions for antidepressants .\
RESULTS	The collaborative care patients experienced an average of 14.6 additional depression-free days over the nine months .\
RESULTS	The mean incremental cost of the intervention per patient was $ 237 US dollars for depression treatment and $ 519 US dollars for total outpatient costs .\
RESULTS	A majority of the additional expenditures were accounted for by the intervention .\
RESULTS	The incremental cost-effectiveness ratio was $ 24 US dollars per depression-free day for depression treatment costs and $ 33 US dollars for total outpatient cost .\
CONCLUSIONS	Better coordination and communication under collaborative care was associated with a greater number of patients being treated for depression and with moderate increases in days free of depression and in treatment cost .\
CONCLUSIONS	Additional resources are needed for effective collaborative care models for depression treatment in primary care .\
\
###25233662\
OBJECTIVE	To explore the anesthetic effect of preemptive analgesia of frequency acupoint electrical stimulation on painless-induced abortion as well as its effect on anesthetics dosage .\
METHODS	Ninety cases of early pregnancy who selected painless-induced abortion were randomly divided into two groups , 45 cases in each group .\
METHODS	Frequency acupoint electrical stimulation at Ciliao ( BL 32 ) and Shenshu ( BL 23 ) , disperse-densewave , 2 Hz/100 Hz in frequency for 15 to 20 min , was applied in the group A , which was followed by intravenous anesthesia of propofol .\
METHODS	The intravenous anesthesia of propofol was applied in the group B.\
METHODS	The blood pressure ( BP ) , heart rate ( HR ) and SpO2 before , during and after surgery , anesthetic effect and dosage , waking time and adverse events were observed in the two groups .\
RESULTS	The BP and HR during and after the surgery in the group A were not statistically different from those before the surgery ( all P > 0.05 ) .\
RESULTS	The BP was reduced and HR was slowed down during the surgery in the group B , which was significantly different from those before the surgery as well as those in the group A ( all P < 0.05 ) .\
RESULTS	The dosage of propofol was ( 114.3 - +6.1 ) mg in the group A. obviously less than ( 193.2 + / - 8.9 ) mg in the group B ( P < 0.05 ) .\
RESULTS	The waking time was ( 5.6 + / - 1.2 ) min in the group A , obviously less than ( 10.1 + / - 3.9 ) min in the group B ( P < 0.05 ) .\
RESULTS	As for anesthetic effect , the incidence of Grade I in the group A was more than the group B ( P < 0.05 ) .\
RESULTS	The adverse events , including nausea , vomiting and contractions pain in the group A were evidently less than those in the group B ( all P < 0.05 ) .\
CONCLUSIONS	The preemptive analgesia of frequency acupoint electrical stimulation could significantly improve anesthetic effect of painless-induced abortion , reduce dosage of anesthetics , shorten waking time of surgery and guarantee the safety of surgery .\
\
###14982912\
BACKGROUND	Small open-label and controlled trials suggest that the antiepileptic drug topiramate is effective for migraine prevention .\
OBJECTIVE	To assess the efficacy and safety of topiramate for migraine prevention in a large controlled trial .\
METHODS	A 26-week , randomized , double-blind , placebo-controlled study was conducted during outpatient treatment at 52 North American clinical centers .\
METHODS	Patients were aged 12 to 65 years and had a 6-month history of migraine ( International Headache Society criteria ) and 3 to 12 migraines a month but no more than 15 headache days a month during a 28-day prospective baseline phase .\
METHODS	After a washout period , patients meeting entry criteria were randomized to topiramate ( 50 , 100 , or 200 mg/d ) or placebo .\
METHODS	Topiramate was titrated by 25 mg/wk for 8 weeks to the assigned or maximum tolerated dose , whichever was less .\
METHODS	Patients continued receiving that dose for 18 weeks .\
METHODS	The primary efficacy measure was change from baseline in mean monthly migraine frequency .\
METHODS	Secondary efficacy measures included responder rate ( proportion of patients with > or = 50 % reduction in monthly migraine frequency ) , reductions in mean number of monthly migraine days , severity , duration , and days a month requiring rescue medication , and adverse events .\
METHODS	The month of onset of preventive treatment action was assessed .\
RESULTS	Of 483 patients randomized , 468 provided at least 1 postbaseline efficacy assessment and comprised the intent-to-treat population .\
RESULTS	Mean monthly migraine frequency decreased significantly for patients receiving topiramate at 100 mg/d ( -2.1 , P = .008 ) and topiramate at 200 mg/d ( -2.4 , P < .001 ) vs placebo ( -1.1 ) .\
RESULTS	Statistically significant reductions ( P < .05 ) occurred within the first month with topiramate at 100 and 200 mg/d .\
RESULTS	The responder rate was significantly greater with topiramate at 50 mg/d ( 39 % , P = .01 ) , 100 mg/d ( 49 % , P < .001 ) , and 200 mg/d ( 47 % , P < .001 ) vs placebo ( 23 % ) .\
RESULTS	Reductions in migraine days were significant for the 100-mg/d ( P = .003 ) and 200-mg/d ( P < .001 ) topiramate groups .\
RESULTS	Rescue medication use was reduced in the 100-mg/d ( P = .01 ) and 200-mg/d ( P = .005 ) topiramate groups .\
RESULTS	Adverse events resulting in discontinuation in the topiramate groups included paresthesia , fatigue , and nausea .\
CONCLUSIONS	Topiramate showed significant efficacy in migraine prevention within the first month of treatment , an effect maintained for the duration of the double-blind phase .\
\
###8098220\
OBJECTIVE	To find out in a prospective study whether beta 1 blocker treatment causes selective beta 2 adrenoreceptor sensitisation , and to find whether such sensitisation is confined to the heart .\
METHODS	A placebo controlled cross over study of two weeks of selective beta 1 blocker treatment with 10 mg of bisoprolol daily .\
METHODS	Six healthy volunteers .\
METHODS	Three days after stopping the 10 mg of bisoprolol or placebo , subjects underwent treadmill exercise ( to measure cardiac beta 1 receptor responsiveness ) and were given salbutamol injections ( to measure cardiac beta 2 receptor responsiveness ) .\
METHODS	Secondary end points were the responses of serum potassium , glucose , and insulin to beta 2 stimulation .\
RESULTS	There was no difference in exercise induced increases in heart rate , but after treatment with bisoprolol the dose of salbutamol required to increase heart rate by 40 beats/min was 1.9 micrograms/kg compared with 2.9 micrograms/kg after placebo ( p < 0.005 ) .\
RESULTS	The fall in diastolic blood pressure was not significantly different on the two occasions .\
RESULTS	Hypokalaemia induced by salbutamol , but not hyperglycaemia or hyperinsulinaemia , was enhanced after bisoprolol .\
CONCLUSIONS	This study shows that treatment with a beta 1 blocker in vivo leads to sensitisation of cardiac beta 2 adrenoreceptors but not cardiac beta 1 adrenoreceptors or vascular beta 2 receptors .\
CONCLUSIONS	This previously unrecognised form of receptor cross sensitisation in the heart may noticeably diminish the efficacy of selective beta 1 blockade in preventing arrhythmias in patients with ischaemic heart disease .\
CONCLUSIONS	These findings reopen the question of which type of beta blocker is more appropriate for such patients .\
\
###20003299\
BACKGROUND	Bisphosphonates can reduce fracture risk in patients with osteoporosis , but many at-risk patients do not start or adhere to these medications .\
BACKGROUND	The aims of this study are to : ( 1 ) preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid ( OSTEOPOROSIS CHOICE ) for postmenopausal women at risk for osteoporotic fractures ; and ( 2 ) assess the feasibility and validity ( i.e. , absence of contamination ) of patient-level randomization ( vs. cluster randomization ) in pilot trials of decision aid efficacy .\
METHODS	This is a protocol for a parallel , 2-arm , randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care .\
METHODS	Postmenopausal women with bone mineral density T-scores of < -1.0 , not receiving bisphosphonate therapy , and receiving care at participating primary care practices in and around Rochester , Minnesota , USA will be eligible to participate in the trial .\
METHODS	We will measure the effect of OSTEOPOROSIS CHOICE on five outcomes : ( a ) patient knowledge regarding osteoporosis risk factors and treatment ; ( b ) quality of the decision-making process for both the patient and clinician ; ( c ) patient and clinician acceptability and satisfaction with the decision aid ; ( d ) rate of bisphosphonate use and adherence , and ( e ) trial processes ( e.g. , ability to recruit participants , collect patient outcomes ) .\
METHODS	To capture these outcomes , we will use patient and clinician surveys following each visit and video recordings of the clinical encounters .\
METHODS	These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients ( i.e. , contamination ) .\
METHODS	Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months .\
CONCLUSIONS	This pilot trial will provide evidence of feasibility , validity of patient randomization , and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures .\
CONCLUSIONS	The results will inform the design of a larger trial that could provide more precise estimates of the efficacy of the decision aid .\
BACKGROUND	Clinical Trials.gov Identifier : NCT00578981 .\
\
###10431273\
OBJECTIVE	To evaluate and compare in a double-blinded and prospective study the incidence of adverse reactions between two contrast agents used for coronary angiography and ventriculography .\
OBJECTIVE	The first agent was the non-ionic , dimeric , isotonic contrast medium iodixanol ( Visipaque ) , the other was the ionic dimeric contrast medium ioxaglate ( Hexabrix ) .\
METHODS	A total of 110 consecutive patients were randomized and received either iodixanol 320 mgl/ml or ioxaglate 320 mgl/ml .\
METHODS	The efficacy , safety , tolerability and specific cardiovascular effects were evaluated .\
METHODS	Adverse reactions were recorded during the procedure and during the first 24 hours after the examination .\
METHODS	Hemodynamic and electrophysiological parameters were recorded before and after the ventricular injection and the first injections into the left and right coronary artery , respectively .\
RESULTS	The incidence of clinical adverse reactions was significantly different between iodixanol and ioxaglate ( 3 % vs 28 % , p = 0.0004 ) .\
RESULTS	24 patients ( 16 iodixanol ; 8 ioxaglate ) experienced no discomfort ( sensation of warmth , coldness or pain ) , and the intensity of discomfort experienced by the remainder was similar for the two groups .\
RESULTS	No patient reported pain .\
RESULTS	During the 3 minutes after injection of contrast medium , the LV end-diastolic pressure increased but , apart from one reading , the increases with iodixanol were always significantly different ( p < 0.05 ) , and less than those for ioxaglate .\
RESULTS	During the same time period , heart rate was increased to a greater extent by ioxaglate ( p < 0.05 ) .\
RESULTS	QT interval was significantly ( p < 0.05 ) prolonged with both ioxaglate and iodixanol , but the changes were less marked after iodixanol .\
RESULTS	The angiographic studies were of diagnostic quality for all patients and optimal diagnostic information was achieved in 92 % of both groups .\
CONCLUSIONS	This randomized study shows that iodixanol and ioxaglate are of comparable diagnostic efficacy in coronary angiography and ventriculography , but that iodixanol is better tolerated by patients and results in less marked hemodynamic and eletrophysiological changes than does ioxaglate .\
\
###18347895\
BACKGROUND	We previously reported that a physical activity ( PA ) behavior change intervention based on the theory of planned behavior ( TPB ) increased PA and quality of life in breast cancer survivors .\
OBJECTIVE	To examine the effects of our interventions on TPB variables and to determine if PA at 12 weeks follow-up was mediated by TPB variables at 4 weeks .\
METHODS	Breast cancer survivors ( N = 377 ) were randomly assigned to receive either a standard public health recommendation for PA ( SR group ) , a step pedometer alone , or one of two TPB-based behavior change interventions consisting of print materials ( alone or combined with a step pedometer ) .\
METHODS	For the purpose of this study , we compared the two TPB-based intervention groups ( INT group ) to the SR group .\
RESULTS	Compared to the SR group , the INT group reported more favorable changes in instrumental attitude ( mean difference = 0.13 ; 95 % CI = -0.01 to 0.23 ; d = 0.19 ; p = 0.077 ) , intention ( mean difference = 0.33 ; 95 % CI = 0.10 to 0.56 ; d = 0.33 ; p = 0.006 ) , and planning ( mean difference = 0.39 ; 95 % CI = 0.04 to 0.73 ; d = 0.26 ; p = 0.027 ) .\
RESULTS	Mediation analyses indicated that both planning and intention partially mediated the effects of the intervention on PA at 12 weeks .\
CONCLUSIONS	Our TPB-based behavior change intervention resulted in small improvements in the TPB constructs that partially mediated the effects of our intervention on PA behavior .\
CONCLUSIONS	Additional research with the TPB is warranted .\
\
###21376385\
BACKGROUND	Treatments with survival benefit are greatly needed for women with heavily pretreated metastatic breast cancer .\
BACKGROUND	Eribulin mesilate is a non-taxane microtubule dynamics inhibitor with a novel mode of action .\
BACKGROUND	We aimed to compare overall survival of heavily pretreated patients receiving eribulin versus currently available treatments .\
METHODS	In this phase 3 open-label study , women with locally recurrent or metastatic breast cancer were randomly allocated ( 2:1 ) to eribulin mesilate ( 14 mg/m ( 2 ) administered intravenously during 2-5 min on days 1 and 8 of a 21-day cycle ) or treatment of physician 's choice ( TPC ) .\
METHODS	Patients had received between two and five previous chemotherapy regimens ( two or more for advanced disease ) , including an anthracycline and a taxane , unless contraindicated .\
METHODS	Randomisation was stratified by geographical region , previous capecitabine treatment , and human epidermal growth factor receptor 2 status .\
METHODS	Patients and investigators were not masked to treatment allocation .\
METHODS	The primary endpoint was overall survival in the intention-to-treat population .\
METHODS	This study is registered at ClinicalTrials.gov , number NCT00388726 .\
RESULTS	762 women were randomly allocated to treatment groups ( 508 eribulin , 254 TPC ) .\
RESULTS	Overall survival was significantly improved in women assigned to eribulin ( median 131 months , 95 % CI 118-143 ) compared with TPC ( 106 months , 93-125 ; hazard ratio 081 , 95 % CI 066-099 ; p = 0041 ) .\
RESULTS	The most common adverse events in both groups were asthenia or fatigue ( 270 [ 54 % ] of 503 patients on eribulin and 98 [ 40 % ] of 247 patients on TPC at all grades ) and neutropenia ( 260 [ 52 % ] patients receiving eribulin and 73 [ 30 % ] of those on TPC at all grades ) .\
RESULTS	Peripheral neuropathy was the most common adverse event leading to discontinuation from eribulin , occurring in 24 ( 5 % ) of 503 patients .\
CONCLUSIONS	Eribulin showed a significant and clinically meaningful improvement in overall survival compared with TPC in women with heavily pretreated metastatic breast cancer .\
CONCLUSIONS	This finding challenges the notion that improved overall survival is an unrealistic expectation during evaluation of new anticancer therapies in the refractory setting .\
BACKGROUND	Eisai .\
\
###21551025\
OBJECTIVE	Although limited health literacy is estimated to affect over 90 million Americans and is recognized as an important public health concern , there have been few studies examining this issue in patients with chronic kidney disease .\
OBJECTIVE	We sought to characterize the prevalence of and associations of demographic and clinical characteristics with limited health literacy in patients receiving maintenance hemodialysis .\
METHODS	As part of a prospective clinical trial of symptom management strategies in 288 patients treated with chronic hemodialysis , we assessed health literacy using the Rapid Estimate of Adult Literacy in Medicine ( REALM ) .\
METHODS	We defined limited health literacy as a REALM score 60 and evaluated independent associations of demographic and baseline clinical characteristics with limited health literacy using multivariable logistic regression .\
RESULTS	Of the 260 patients who completed the REALM , 41 demonstrated limited health literacy .\
RESULTS	African-American race , lower educational level , and veteran status were independently associated with limited health literacy .\
RESULTS	There was no association of limited health literacy with age , gender , serologic values , dialysis adequacy , overall symptom burden , quality of life , or depression .\
CONCLUSIONS	Limited health literacy is common among patients receiving chronic hemodialysis .\
CONCLUSIONS	African-American race and socioeconomic factors are strong independent predictors of limited health literacy .\
CONCLUSIONS	These findings can help inform the design and implementation of interventions to improve health literacy in the hemodialysis population .\
\
###17973947\
OBJECTIVE	Progestins are commonly prescribed for hormone replacement therapy ( HRT ) and contraception .\
OBJECTIVE	However , the effects of progestins on bone metabolism remain unclear and are often controversial .\
METHODS	This study was conducted to test the hypothesis that progestins with no significant glucocorticoid activity may be a better choice for HRT to achieve increased beneficial effects on bone metabolism than progestins with strong glucocorticoid activity .\
METHODS	A total of 104 postmenopausal women aged 50-75 years with osteoporosis were allocated randomly to three groups : ( 1 ) conjugated oestrogen plus medroxyprogesterone acetate ( HRT-MPA , with significant glucocorticoid activity ) ; ( 2 ) conjugated oestrogen plus norethisterone ( HRT-NET , with no significant glucocorticoid activity ) ; and ( 3 ) control ( no treatment ) .\
METHODS	Vertebral X-rays and bone mineral density ( BMD ) at distal 1/3 radius were assessed at baseline and every 6 months during the 2-year study period , along with markers of bone turnover .\
METHODS	The occurrence of new nonvertebral fractures was identified by X-ray .\
RESULTS	After the 2-year treatment , mean BMD changes relative to baseline in the HRT-MPA , HRT-NET and control groups were 1.6 % , 2.3 % and -1.9 % , respectively .\
RESULTS	In addition , the rate of increase in HRT-NET was significantly greater than that in HRT-MPA ( P = 0.019 ) .\
RESULTS	The incidence of new fractures during the 2-year treatment in the control group was 26 % ( 9/34 ) .\
RESULTS	HRT-NET treatment significantly inhibited the occurrence of new fractures ( RR 0.14 , 95 % CI 0.02-0 .93 , P = 0.04 ) , while HRT-MPA treatment failed to show a statistically significant reduction ( RR 0.41 , 95 % CI 0.14-1 .24 , P = 0.11 ) .\
RESULTS	Both HRT-MPA and HRT-NET treatments significantly decreased serum osteocalcin levels by 29.4 % and 23.5 % , respectively , after 6 months of treatment , with the decrease in HRT-MPA being significantly greater than that in HRT-NET ( P = 0.042 ) .\
CONCLUSIONS	These findings suggest that progestins with no significant glucocorticoid activity may be a better choice for HRT , resulting in increased beneficial effects on bone metabolism compared with progestins with strong glucocorticoid activity .\
\
###19243306\
BACKGROUND	This randomised , double-blind , double-dummy , parallel-group multicentre study assessed the impact of a total daily dose of 60-80 mg oral oxycodone prolonged-release ( PR ) / naloxone PR ( OXN PR ) as fixed-ratio combination for patients with opioid-induced constipation ( OIC ) having moderate-to-severe , non-malignant pain .\
METHODS	During pre-randomisation patients receiving opioids for moderate-to-severe non-malignant pain were converted to oxycodone PR ( OXY PR ) and titrated to an effective analgesic dose .\
METHODS	During randomisation 265 patients on a stable OXY PR dose ( 60-80 mg/day ) and with OIC were included in the full analysis population to receive OXN PR or OXY PR alone .\
METHODS	Primary outcome was improvement in symptoms of constipation as measured by the Bowel Function Index ( BFI ) .\
METHODS	Secondary/exploratory outcomes examined analgesic efficacy and other bowel function parameters .\
RESULTS	After 4 weeks of treatment , patients receiving OXN PR showed a significant improvement in bowel function compared with those in the OXY PR group ( -14.9 ; 95 % CI : -17.9 , -11.9 ; p < 0.0001 ) as measured by BFI which was seen after only 1 week of treatment continuing to the end of the study .\
RESULTS	After 4 weeks of treatment , patients receiving OXN PR had a median number of 3.0 complete spontaneous bowel movements ( CSBM ) per week compared with only 1.0 for OXY PR alone .\
RESULTS	Laxative intake was lower in the OXN PR than the OXY PR group .\
RESULTS	Furthermore , improvements in bowel function were achieved without loss of analgesic efficacy ; pain intensity scores were comparable between the groups and consistent for duration of the study .\
RESULTS	Most frequently reported adverse events were consistent with those reported for opioid analgesics ; no new or unexpected adverse reactions attributable to OXN PR used in higher doses were observed .\
CONCLUSIONS	This study shows that the fixed-ratio combination of OXN PR is superior to OXY PR alone in terms of bowel function , while providing effective equivalent analgesia .\
\
###24292995\
OBJECTIVE	To develop prognostic models for time to 12-month remission and time to treatment failure after initiating antiepileptic drug monotherapy for generalised and unclassified epilepsy .\
METHODS	We analysed data from the Standard and New Antiepileptic Drug ( arm B ) study , a randomised trial that compared initiating treatment with lamotrigine , topiramate and valproate in patients diagnosed with generalised or unclassified epilepsy .\
METHODS	Multivariable regression modelling was used to investigate how clinical factors affect the probability of achieving 12-month remission and treatment failure .\
RESULTS	Significant factors in the multivariable model for time to 12-month remission were having a relative with epilepsy , neurological insult , total number of tonic-clonic seizures before randomisation , seizure type and treatment .\
RESULTS	Significant factors in the multivariable model for time to treatment failure were treatment history ( antiepileptic drug treatment prior to randomisation ) , EEG result , seizure type and treatment .\
CONCLUSIONS	The models described within this paper can be used to identify patients most likely to achieve 12-month remission and most likely to have treatment failure , aiding individual patient risk stratification and the design and analysis of future epilepsy trials .\
\
###23903802\
BACKGROUND	Secondary hyperparathyroidism ( SHPT ) is common in end-stage renal disease .\
BACKGROUND	Our primary objective was to evaluate the efficacy of oral paricalcitol versus oral calcitriol on serum intact parathyroid hormone ( iPTH ) and mineral bone parameters in continuous ambulatory peritoneal dialysis ( CAPD ) patients with SHPT .\
BACKGROUND	The secondary objective was to analyze highly sensitive C-reactive protein ( hsCRP ) and peritoneal membrane function in both groups .\
METHODS	This was a prospective randomized control trial .\
METHODS	CAPD patients with SHPT were randomized to paricalcitol or calcitriol for 15 weeks .\
METHODS	Serum intact iPTH , calcium , phosphate and alkaline phosphatase ( ALP ) were measured at baseline and every 3 weeks .\
METHODS	Serum hsCRP and peritoneal membrane functions were measured at baseline and at week 15 .\
RESULTS	A total of 26 patients were enrolled and randomized-12 to paricalcitol and 14 to calcitriol .\
RESULTS	Serum iPTH reduced significantly in both groups and there was no difference in the incidence of 50 % reduction of iPTH between both groups .\
RESULTS	There was a significant increase in serum calcium in both groups but there were no differences in serum phosphorus across the visits .\
RESULTS	The incidence of hypercalcemia was the same in both groups .\
RESULTS	Serum calcium-phosphorus ( Ca P ) product increased in the paricalcitol group but decreased in the calcitriol group .\
RESULTS	Serum ALP decreased significantly in both groups .\
RESULTS	There were also no differences in pre - and post-treatment serum hsCRP and peritoneal function test ( PFT ) in both groups .\
CONCLUSIONS	Both oral paricalcitol and calcitriol were equally efficacious in reducing serum iPTH but were associated with significantly higher serum calcium .\
CONCLUSIONS	Serum Ca P product increased in the paricalcitol group and decreased in the calcitriol group .\
CONCLUSIONS	Serum hsCRP level and PFT were not affected by either treatment .\
CONCLUSIONS	A larger randomized controlled trial is indicated to confirm these initial findings .\
\
###16870076\
BACKGROUND	Natural rubber latex ( NRL ) allergy remains an important allergic disease triggering urticaria , asthma , angioedema and anaphylaxis .\
BACKGROUND	Specific immunotherapy can help to solve problems related to NRL allergy .\
BACKGROUND	So far , no controlled clinical trials have been performed in children suffering from NRL allergy .\
OBJECTIVE	To evaluate the safety and efficacy of sublingual immunotherapy ( SLIT ) with a commercial NRL extract in children with NRL allergy .\
METHODS	Randomized , double-blind , placebo-controlled , 12-month trial .\
METHODS	Twenty-six children ( aged 4-15 years ) with NRL allergy , who had cutaneous and/or respiratory symptoms , including oral allergy syndrome to fruits containing cross-reactive allergens , were recruited .\
METHODS	Twelve children were randomized to SLIT with a commercial NRL extract and eight to placebo ( 3:2 ) .\
METHODS	An additional six children with NRL allergy served as untreated controls .\
METHODS	A glove use test was utilized to monitor skin and systemic symptoms triggered by NRL exposure at baseline and 3 , 6 , 9 and 12 months later .\
METHODS	Oral allergy symptoms were also monitored .\
RESULTS	No side effects related to treatments were observed in any patient .\
RESULTS	A significant improvement of symptom score in treated patients in comparison with baseline values was observed at 3 months ( p = 0.01 ) and consolidated after 1 year of treatment ( p = 0.0005 ) .\
RESULTS	In comparison with placebo , significant improvements were observed starting at 9 months from study start ( p = 0.015 ) and at 12 months ( p = 0.005 ) .\
RESULTS	The number of foods triggering oral allergy symptoms increased in placebo and control subjects , but not in active treated patients ( p = 0.05 ) .\
CONCLUSIONS	Latex SLIT was safe and efficacious in paediatric patients with NRL allergy .\
\
###14763958\
OBJECTIVE	The reduction of blood pressure ( BP ) caused by nimodipine has been proposed as an explanation for the poor results in ischemic stroke trials .\
OBJECTIVE	We evaluated further the relationships between BP , nimodipine , and outcome of ischemic stroke , and also searched for other possible explaining mechanisms .\
METHODS	All 350 participants of an earlier placebo controlled trial on oral nimodipine were included in this study .\
METHODS	Among other variables , the admission BP , and the change of BP during the first day were noted .\
METHODS	The 3 week and 3 month functional outcome was assessed with a modified Rankin grading .\
RESULTS	The severity of stroke was the utmost important predictor of outcome .\
RESULTS	Visible cerebral infarction on computed tomography ( CT ) was associated with severe stroke and an early commencement ( within 24 h of stroke onset ) of nimodipine treatment .\
RESULTS	In the nimodipine arm , high initial systolic and diastolic BP measured < or = 24 h of stroke onset were independent predictors of good functional outcome ( Rankin grades 1 and 2 ) , whereas BP change was not .\
RESULTS	The survivors in the nimodipine arm with mild to moderately severe stroke had higher initial BP than the deceased ones , in severe strokes the situation was the opposite .\
CONCLUSIONS	Stroke severity , visible cerebral infarcts on CT , and early commencement of nimodipine treatment were associated .\
CONCLUSIONS	Overall , high initial systolic and diastolic BP predicted a good functional outcome in patients on nimodipine .\
CONCLUSIONS	In severe strokes , the combination of nimodipine and high initial BP was associated with increased risk of death .\
\
###11755835\
OBJECTIVE	To assess , before and during oral nonsteroidal anti-inflammatory drug coadministration , latanoprost 's and brimonidine 's hypotensive action in eyes at risk of glaucomatous progression , assessing the effect of each drug on ocular perfusion and visual function .\
METHODS	Twenty consenting adults with open-angle glaucoma or ocular hypertension underwent a double-masked , bilateral , randomized prospective study .\
METHODS	Treatment started with either latanoprost 0.005 % in the morning and placebo in the evening , or brimonidine 0.2 % twice daily in one eye ; after 1 week starting the other in the fellow eye .\
METHODS	After another week , oral indomethacin 25 mg four times a day , commenced for 2 more weeks .\
METHODS	Intraocular pressure , ocular circulation , and visual function were monitored pretreatment , after unilateral monotherapy ( day 7 ) , bilateral ocular therapy ( day 14 ) , and coadministered oral indomethacin ( day 28 ) .\
METHODS	Intrasubject differences ( interocular and intraocular relative to baseline ) were determined by two-tailed paired t test .\
RESULTS	A loss of the significance of intraocular pressure reduction with brimonidine was noted after oral indomethacin coadministration ( -14 % ; P = .004 for brimonidine alone versus -11 % ; P = .3 with indomethacin ) .\
RESULTS	Significant intraocular pressure reduction with latanoprost persisted despite indomethacin ( -25 % ; P < .0001 for latanoprost alone versus -30 % ; P < .0001 with indomethacin ) .\
RESULTS	Pulsatile ocular blood flow increased 40 % with latanoprost , but was unchanged with brimonidine ( interdrug difference , P = .004 ) .\
RESULTS	Midperipheral retinal microcirculation increased 23 % ( P = .03 ) with latanoprost .\
RESULTS	Humphrey perimetry and contrast sensitivity remained consistently at or above baseline with both latanoprost and brimonidine .\
RESULTS	Indomethacin had no significant effect on ocular perfusion or visual function measures .\
CONCLUSIONS	Circulatory and hydrodynamic findings differed substantially for the two drugs .\
CONCLUSIONS	The loss of significance of intraocular pressure reduction with brimonidine during indomethacin treatment may be clinically important .\
\
###11048353\
OBJECTIVE	To evaluate outcomes 1 year after cessation of treatment for cocaine - and alcohol-dependent individuals .\
METHODS	Randomized controlled trial .\
METHODS	Urban substance abuse treatment center .\
METHODS	Ninety-six of 122 subjects randomized to treatment .\
METHODS	One of five treatments delivered over 12 weeks .\
METHODS	Cognitive-behavioral treatment ( CBT ) plus disulfiram ; Twelve-Step facilitation ( TSF ) plus disulfiram ; clinical management ( CM ) plus disulfiram ; CBT without disulfiram ; TSF without disulfiram .\
METHODS	Percentage of days of cocaine and alcohol use during follow-up , verified by urine toxicology screens and breathalyzer tests .\
RESULTS	First , as a group , participants reported significant decreases in frequency of cocaine , but not alcohol , use after the end of treatment .\
RESULTS	Secondly , the main effects of disulfiram on cocaine and alcohol use were sustained during follow-up .\
RESULTS	Finally , initiation of abstinence for even brief periods of time within treatment was associated with significantly better outcome during follow-up .\
CONCLUSIONS	These findings support the efficacy of disulfiram with this challenging population and suggest that comparatively brief treatments that facilitate the initiation of abstinence may have long-term benefits .\
\
###15199033\
BACKGROUND	The high prevalence of acne vulgaris and its significant morbidity underscore the need for convenient , low-risk , and efficacious therapy .\
BACKGROUND	Treatment with various lasers has been reported to improve acne .\
OBJECTIVE	To evaluate the clinical efficacy of pulsed dye laser therapy in the treatment of acne .\
METHODS	Randomized , single-blind , controlled , split-face clinical trial of a volunteer sample of 40 patients aged 13 years or older with facial acne conducted at an academic referral center from August 2002 to September 2003 .\
METHODS	One or 2 nonpurpuric pulsed dye laser treatments to half of the face ( fluence of 3 J/cm2 ) , serial blinded clinical assessments ( lesion counts ) , and grading of acne severity using standardized bilateral serial photographs .\
METHODS	Comparison of the changes in lesion counts from baseline to 12 weeks between treated and untreated sides of the face and changes in photographic evidence of acne severity as graded by a panel of dermatologists blinded to treatment assignment .\
RESULTS	After 12 weeks , using intent-to-treat analysis with last observation carried forward , there were no significant differences between laser-treated and untreated skin for changes in mean papule counts ( -4.2 vs -2.2 ; P = .08 ) , mean pustule counts ( 0 vs -1.0 ; P = .12 ) , or mean comedone counts ( 2.9 vs 1.6 ; P = .63 ) .\
RESULTS	Grading of serial photographs confirmed the clinical assessments , showing no significant mean ( SE ) differences in Leeds scores ( range , 1-12 ) for treated skin ( 3.98 [ 0.32 ] at baseline and 3.94 [ 0.27 ] at week 12 ) compared with untreated skin ( 3.83 [ 0.32 ] at baseline and 3.79 [ 0.28 ] at week 12 ) ( P > .99 ) .\
CONCLUSIONS	In this study , the nonpurpuric pulsed dye laser therapy did not result in significant improvement of facial acne .\
CONCLUSIONS	More research is needed before this laser therapy may be recommended as an acne treatment .\
\
###22372517\
BACKGROUND	Diclofenac-potassium ( diclofenac -- K ) 25 mg liquid capsule is absorbed more quickly than the tablet formulation .\
BACKGROUND	It offers potential for rapid pain relief , but may alter gastro-duodenal tolerability .\
OBJECTIVE	To evaluate the gastro-duodenal tolerance of diclofenac-K 25 mg liquid capsules vs. diclofenac-K 12.5 mg tablets , acetylsalicylic acid ( ASA ) 500 mg tablets and ibuprofen 200 mg liquid capsules .\
METHODS	In an endoscopist-blinded , randomised , parallel-group study , volunteers received 15 doses of diclofenac-K 25 mg liquid capsules ( n = 36 ) , diclofenac-K 2 12.5 mg tablets ( n = 36 ) , ibuprofen 2 200 mg liquid capsules ( n = 24 ) or ASA 2 500 mg tablets ( n = 36 ) over 5 days .\
METHODS	The primary outcome was the incidence of erosive gastro-duodenal lesions at Day 6 .\
METHODS	Secondary outcomes included modified Lanza score and change in gastric mucosal prostaglandin synthesis .\
RESULTS	The lowest incidence of erosive gastro-duodenal lesions was with diclofenac-K liquid capsules ( 53 % ) , compared to 61 % with diclofenac-K tablets ( P = 0.52 ) , 75 % with ibuprofen ( P = 0.08 ) and 94 % with ASA ( P = 0.001 ) .\
RESULTS	Results were similar for the Lanza scores , although diclofenac-K liquid capsules were significantly superior to ibuprofen liquid capsules ( P = 0.04 ) .\
RESULTS	Diclofenac-K liquid capsules inhibited prostaglandin synthesis by 52 % compared to 64 % for diclofenac-K tablets ( P = 0.10 ) , 50 % for ibuprofen ( P = 0.85 ) and 79 % for ASA ( P = 0.002 ) .\
RESULTS	With respect to safety , adverse events were most frequent in the ASA group , predominantly gastrointestinal events .\
CONCLUSIONS	Mucosal injury with diclofenac-K liquid 25 mg liquid capsules was similar to diclofenac-K 25 mg tablets , significantly lower than ASA 1 g tablets and showed some superiority over ibuprofen 400 mg liquid capsules ( EudraCT Number 2009-011278-14 ) .\
\
###11903078\
BACKGROUND	Patient-controlled analgesia ( PCA ) techniques and intrathecal morphine are the most widely used treatments for post-Caesarean section pain .\
BACKGROUND	However these methods have not been compared with respect to analgesic quality and cost differences .\
METHODS	Fifty-three patients scheduled for elective or semi-urgent Caesarean section were randomized to receive for postoperative analgesia either epidural PCA with a mixture containing bupivacaine 0.06 % and sufentanil 1 microg x ml ( -1 ) or intrathecal morphine 0.15 mg together with the spinal anaesthetic and to be supplemented with paracetamol and tramadol .\
METHODS	Analgesic efficacy , side-effects and costs were calculated during 48 h.\
RESULTS	VAS pain scores both at rest and during mobilization were lower in the PCA group , more particularly during the second postoperative day .\
RESULTS	Nausea and vomiting were more frequently registered in the morphine treated patients .\
RESULTS	PCA treated patients stayed longer in the recovery room but required fewer nurse interventions on the surgical ward .\
RESULTS	Manpower and drug costs were equal in both groups .\
RESULTS	The differences in total costs ( Euro ) amounted to euros 33 and were mainly caused by the more expensive equipment required for epidural PCA .\
RESULTS	Satisfaction and hospital discharge were similar for both treatments .\
CONCLUSIONS	It was concluded that epidural PCA induced better pain relief , caused less nausea/vomiting but was more expensive than intrathecal morphine .\
\
###22124067\
OBJECTIVE	The aim of the study was to evaluate and compare the oral stereognostic ability and satisfaction for fixed prosthesis in human being .\
METHODS	The present study was carried out on 40 subjects , the purpose being to investigate the relation of oral perception to diagnostic and therapeutic procedures .\
METHODS	Two types of cast metal crowns -- one had morphology closely resembling original tooth and other one confirmed to ideal contours were constructed on endodontically treated posterior tooth .\
METHODS	One cast metal crown was randomly selected from two cast metal crown and fitted on prepared tooth .\
METHODS	Oral stereognostic score of subject was determined by correct response to questionnaire based on the recognition ability of subjects .\
METHODS	Patient satisfaction level was checked by psychometric parameter Likert scale .\
METHODS	Same procedure was repeated with other type of cast metal crown .\
RESULTS	Data obtained were compared by paired and unpaired two sample t-test .\
RESULTS	Oral stereognostic score and satisfaction score were found to be higher for cast metal crown with morphology resembling to original tooth due to recognition and discriminatory ability of subjects and recall-memory .\
RESULTS	Oral stereognostic level was found to be higher in younger than older subjects .\
RESULTS	The level of satisfaction was found to be higher in older subjects than younger subjects .\
CONCLUSIONS	It was concluded that acceptance of fixed prosthesis is not only based on dentist 's routine procedure of treatment and patient 's judgment about oral health , function , and esthetics , but also depends upon patient 's oral perception and discriminatory skill for external morphology of fixed prosthesis .\
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###22517886\
OBJECTIVE	Current National Health Service cervical screening information does not explain that the cause of cervical cancer is a sexually transmitted infection ( human papillomavirus ( HPV ) ) .\
OBJECTIVE	This study aimed to consider the impact that providing this information , in addition to risk factor information , might have on women 's perceived risk of cervical cancer .\
METHODS	Female students aged 18-24 years ( n = 606 ) completed a web-based survey and were randomised to receive ( 1 ) control information about cervical cancer ; ( 2 ) details of the link between HPV and cervical cancer ; ( 3 ) risk factor information or ( 4 ) details about the link with HPV + risk factor information .\
METHODS	Risk perceptions for cervical cancer were assessed before and after reading the information .\
RESULTS	There was a significant difference in perceived risk of cervical cancer between the four groups following information exposure ( p = 0.002 ) .\
RESULTS	Compared with the control group , risk perceptions were significantly lower among women given risk factor information but not among those informed about HPV .\
RESULTS	There were significant group by risk factor interactions for smoking status ( p < 0.001 ) , age of first sex ( p = 0.018 ) and number of sexual partners ( p < 0.001 ) .\
RESULTS	Risk perceptions were lower among women considered at low risk and given risk factor information , but there was no association between information group and perceived risk for high-risk women .\
CONCLUSIONS	Providing risk factor information appears to reduce cervical cancer risk perceptions , but learning about the aetiological role of HPV appears to have no impact on risk perceptions .\
CONCLUSIONS	Incorporating brief information about HPV as the cause of cervical cancer should be in addition to , rather than in place of , risk factor information .\
\
###15236891\
OBJECTIVE	To determine the benefit of 24 h intravenous hydration for pediatric postoperative adenotonsillectomy patients .\
METHODS	A prospective , randomized controlled clinical study .\
METHODS	The study is consisting of two groups of pediatric patients following adenotonsillectomy performed in a university hospital .\
METHODS	One group received 24 h IV hydration at hospital while the other did not have IV hydration .\
METHODS	Chi-square and two-tailed unpaired Student 's t-tests were used to compare the two independent groups .\
METHODS	P < 0.05 was accepted as statistically significant .\
RESULTS	Although the postoperative parameters such as nausea , fever , vomiting , odor , bleeding , otalgia and trismus were not statistically different between the two groups based on chi-square analysis ( P > 0.05 ) , a significant pain-relieving effect was seen in hydration group after the second day ( P < 0.05 ) .\
RESULTS	There were no complications associated with intravenous hydration .\
CONCLUSIONS	Results of the current study suggest that 24 h IV hydration can reduce postoperative pain in late postoperative period following adenotonsillectomy in children but does not offer much advantage over without IV hydration therapy based on a number of other parameters .\
CONCLUSIONS	Furthermore , it seems to be cost effective , safe and easy and even these are encouraging for further studies in the future .\
\
###24982917\
OBJECTIVE	The purpose of this study was to compare the analgesic properties of levobupivacaine with or without fentanyl for patient-controlled epidural analgesia after Cesarean section in a randomized , double-blinded study .\
METHODS	We enrolled American Society of Anesthesiologists class I/II , full-term pregnant women at National Taiwan University Hospital who received patient-controlled epidural analgesia after Cesarean section between 2009 and 2010 .\
METHODS	Eighty women were randomly assigned into two groups .\
METHODS	In group A , the 40 subjects received drug solutions made of 0.6 mg/ml levobupivacaine plus 2mcg/ml fentanyl , and in group B the 40 subjects received 1mg/ml levobupivacaine .\
METHODS	Maintenance was self-administered boluses and a continuous background infusion .\
RESULTS	There were no significant differences in the resting and dynamic pain scales and total volume of drug used between the two groups .\
RESULTS	Patient satisfaction was good in both groups .\
CONCLUSIONS	Our study showed that pure epidural levobupivacaine can provide comparative analgesic properties to the levobupivacaine-fentanyl combination after Cesarean section .\
CONCLUSIONS	Pure levobupivacaine may serve as an alternative pain control regimen to avoid opioid-related adverse events in parturients .\
\
###22169682\
OBJECTIVE	Critical limb ischemia , the most severe form of peripheral arterial disease , results in extremity amputation if left untreated .\
OBJECTIVE	Endovascular recanalization of stenotic or occluded infrapopliteal arteries has recently emerged as an effective form of therapy , although the duration of patency is typically limited by restenosis .\
OBJECTIVE	Recently , it has been suggested that drug-eluting stents originally developed for the coronary arteries might also be effective in preventing restenosis in the infrapopliteal arteries .\
OBJECTIVE	This prospective , randomized , controlled clinical trial tested the hypothesis that treatment of infrapopliteal arterial occlusive lesions with an everolimus-eluting stent ( Xience V ) would provide superior patency to treatment with a bare-metal stent ( Multi-Link Vision ) .\
METHODS	A sample size of 140 patients was planned to be enrolled at five European investigative sites .\
METHODS	The primary end point was arterial patency at 12 months , defined as the absence of 50 % restenosis based on quantitative analysis of contrast angiography .\
RESULTS	Between March of 2008 and September of 2009 , 74 patients were treated with Xience V and 66 patients were treated with Vision .\
RESULTS	After 12 months , the primary patency rate after treatment with Xience V was 85 % compared with 54 % after treatment with Vision ( P = .0001 ) .\
RESULTS	Treatment with Xience V significantly reduced mean in-stent diameter stenosis ( 21 % 21 % vs 47 % 27 % ; P < .0001 ) and mean in-stent late lumen loss ( 0.78 0.63 vs 1.41 0.89 mm ; P = .001 ) .\
RESULTS	There were no differences in the percentage of patients receiving a designation of Rutherford class 0 or 1 at the 12-month follow-up visit ( 56 % for Vision , vs 60 % for Xience V ; P = .68 ) .\
RESULTS	Major extremity amputations were rare in both groups ( two for Vision and one for Xience V ) .\
RESULTS	The use of the Xience V stent significantly reduced the need for repeat intervention : freedom from target lesion revascularization was 91 % for Xience V vs 66 % for Vision ( P = .001 ) .\
CONCLUSIONS	Treatment of the infrapopliteal occlusive lesions of critical limb ischemia with everolimus-eluting stents reduces restenosis and the need for reintervention compared with bare metal stents .\
\
###15614114\
OBJECTIVE	The goal of this study was to assess azithromycin and/or benzathine penicillin for treatment of syphilis .\
METHODS	In a population-based study , participants with serologic syphilis ( TRUST with TPHA confirmation ) were offered 2.4 MU benzathine penicillin intramuscularly .\
METHODS	Intervention arm participants received 1 g presumptive oral azithromycin .\
METHODS	We assessed cure rates with penicillin or azithromycin given alone and in combination .\
METHODS	Cure assessed after 10 months was defined as seroreversion or a 4-fold decrease in titer .\
METHODS	The rate ratio ( RR ) of cure and 95 % confidence intervals ( 95 % CIs ) were estimated by log binomial regression .\
RESULTS	Among 952 cases with syphilis , 18 % received penicillin alone , 17 % azithromycin only , and 65 % dual treatment .\
RESULTS	The overall cure rate was 61 % .\
RESULTS	Cure rates were lower in males compared with females ( RR , 0.89 ; 95 % CI , 0.80-0 .99 ) and in subjects with initial titers > or = 1:4 compared with < or = 1:2 ( RR , 0.77 ; 95 % CI , 0.69-0 .86 ) .\
RESULTS	There was no significant differences in cure rates among HIV-positive and HIV-negative persons .\
RESULTS	With initial titers < or = 1:2 , there were no differences in cure rates by treatment regimen .\
RESULTS	However , with initial titers > or = 1:4 , significantly higher cure rates were observed with azithromycin alone ( adjusted RR , 1.38 ; 95 % CI , 0.97-1 .96 ) , and with dual treatment of azithromycin and benzathine penicillin ( RR , 1.38 ; 95 % CI , 1.03-1 .87 ) compared with penicillin alone .\
CONCLUSIONS	Azithromycin alone or in combination with penicillin achieved higher cure rates than penicillin alone in cases with a high initial TRUST titer .\
CONCLUSIONS	In low-titer infections , the 3 drug combinations were equally effective .\
CONCLUSIONS	HIV status did not affect cure rates .\
\
###18669515\
OBJECTIVE	Although personality factors , especially emotional suppression and loss-hopelessness , have been linked to the occurrence and progression of cancer , little is reported specifically on colorectal cancer .\
OBJECTIVE	It has also been claimed that a ` hysterical ' personality characterized by exaggerated emotional expressions , egocentricity and ambivalent connection may be protective from cancer .\
OBJECTIVE	This community-based case-control study examined whether personality factors relevant to emotional suppression or loss-hopelessness are associated with an increased risk of colorectal cancer , and whether factors related to the hysterical personality are associated with a decreased risk .\
METHODS	The stress inventory ( SI ) , a self-administered questionnaire to assess the possible disease-prone and other relevant personalities in Japanese , was completed by 497 patients with newly diagnosed colorectal cancer and 809 controls randomly selected in the Fukuoka area of Japan .\
RESULTS	After controlling for age , sex and residence using a logistic regression model , none of the SI scales relevant to emotional suppression ( ` unfulfilled needs for acceptance ' , ` altruism ' , ` rationalizing conflicts/frustrations ' ) or loss-hopelessness ( ` low sense of control ' , ` object-dependence/loss ' , ` object-dependence/happiness ' ) was related to colorectal cancer .\
RESULTS	On the other hand , two scales representing elements of the hysterical personality , ` object-dependence/ambivalence ' and ` egoism ' were protectively associated with risk .\
RESULTS	Additional adjustment for body-mass index and lifestyle factors did not materially change these associations .\
CONCLUSIONS	Although personalities relevant to the emotional suppression or loss-hopelessness may not be a risk factor for colorectal cancer in the Japanese population , ambivalent connection and egocentricity may be protective .\
\
###11565729\
BACKGROUND	Myocardial ischemia , arrhythmias , and coagulopathies are associated with postoperative hypothermia .\
BACKGROUND	This study assessed the efficacy of a novel thermoregulation system in alleviating these events during coronary artery bypass graft ( CABG ) surgery .\
METHODS	Elective CABG surgery patients were randomized into either Allon thermoregulation ( AT , n = 40 ) or routine thermal care ( RTC , n = 20 ) groups in whom the maintenance of normothermia during the nonbypass phases of the operation was compared .\
METHODS	The AT used patients ' rectal temperature as reference data to monitor the maintenance of the water temperature circulating at 37 degrees C in a garment .\
METHODS	Rectal temperature , patient hemodynamics , and cardiac-specific troponin I ( cTnI ) levels were assessed at the induction of anesthesia , 30 minutes into surgery , at discontinuation of bypass , end of surgery , and 2 hours postoperatively .\
RESULTS	Body temperature was higher in the AT group compared to the RTC group at all five time points .\
RESULTS	Cardiac index ( CI ) ( L/min ) was higher in the AT group , 2.5 + / - 0.5 , 2.6 + / - 0.5 * , 3.2 + / - 0.6 * , 3.3 + / - 0.5 * , 3.1 + / - 0.7 at the respective time points , compared to the RTC group , 2.3 + / - 0.6 , 2.1 + / - 0.2 , 2.6 + / - 0.7 , 2.7 + / - 0.7 , 2.7 + / - 0.7 ( * p < 0.05 ) .\
RESULTS	Systemic vascular resistance ( SVR ) ( dyne x s ) / cm5 ) was consistently lower in the AT patients .\
RESULTS	Enzyme levels were elevated in both groups but were less so in the AT patients .\
CONCLUSIONS	The AT system can efficiently maintain normothermia .\
CONCLUSIONS	The beneficial effects are expressed by reduced SVR , elevated CI , and lower levels of cTnI , which may show a possible attenuation of myocardial injury .\
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###12209085\
BACKGROUND	Nocturnal symptoms of asthma are a cause of significant morbidity and are included as a central feature in the categorization of asthma severity .\
OBJECTIVE	Data from the Childhood Asthma Management Program were used to estimate the prevalence of nocturnal awakenings in 1041 children with mild-to-moderate asthma and to investigate the relationships between awakenings and peak flows , severity of asthma , and allergen sensitivity and exposure .\
METHODS	Daily diary care data were recorded during a 28-day interval in the Childhood Asthma Management Program screening process .\
METHODS	The data on morning and evening peak flows , overall symptom codes , albuterol use for symptoms , and nocturnal awakenings for asthma symptoms were analyzed and compared with measures of personal characteristics , pulmonary function , and environmental characteristics of the patients .\
RESULTS	Three hundred fifty-one ( 33.7 % ) children experienced 1 or more night awakenings caused by asthma during the 28-day screening period while not taking any maintenance medications .\
RESULTS	Greater risk of night awakening was associated with more severe asthma ( greater responsiveness to bronchodilator , airway reactivity to methacholine , peak flow variability , and use of albuterol for symptoms , all P < .0001 ) and atopy ( increased IgE and allergy skin test reactivity , both P = .0002 ) .\
RESULTS	Those with a positive skin test response to dog and a high level of dog allergen in the home had a greater risk of night awakening caused by asthma ( P = .01 ) , as did those with a positive skin test response to cat and a high level of cat allergen in the home ( P = .04 ) .\
RESULTS	Mean daily symptom code and use of albuterol for asthma symptoms increased in the 3 days immediately before a single awakening compared with in the 4 to 6 days before the awakening ( P = .02 and P = .01 , respectively ) ; however , both morning and evening peak flows as a percentage of personal best were similar in both intervals .\
RESULTS	Mean daily symptom code and daily use of albuterol were greater in the 3 days after an awakening than in the 3 days before ( P < .0001 and P = .0002 , respectively ) .\
RESULTS	Mean evening peak flow percentage of personal best the day after an episode of awakening was lower when a second consecutive awakening occurred than when there was only a single awakening ( P = .01 ) .\
CONCLUSIONS	Nocturnal awakening occurred in one third of the children with mild-to-moderate asthma during a month of relative stability and appears to be an indicator of asthma that is becoming increasingly severe .\
\
###20496728\
OBJECTIVE	To compare the effect and safety evaluation of catgut implantation at acupoint and drugs for levels of bone metabolism and free radicals in postmenopausal women .\
METHODS	Sixty-five postmenopausal women were randomly divided into an acupoint catgut implantation group ( 33 cases ) and a medication group ( 32 cases ) .\
METHODS	Sanyinjiao ( SP 6 ) , Shenshu ( BL 23 ) and Guanyuan ( CV 4 ) were used as main points combined with adjunct points according to syndrome differentiation in the acupoint catgut implantation group , once two weeks .\
METHODS	The medication group was treated with oral administration of 2 pills of Fu fuchun capsule , once a day .\
METHODS	Three months constitute one course in the both groups .\
METHODS	The scores of the symptoms and signs were evaluated , and elbow vein blood was drawn to detect the correlative index on the beginning and the ending day of the treatment respectively .\
METHODS	The safety of catgut implantation at acupoint was evaluated after one course of treatment .\
METHODS	Besides , the sex hormone test in ovulatory period was detected in twenty-eight normal women in reproductive age with regular menstrual cycle .\
RESULTS	1 ) The total effective rate of the acupoint catgut implantation group was 93.9 % ( 31/33 ) , and that of the medication group was 96.9 % ( 31/32 ) , there was no significant difference between the two groups ( P > 0.05 ) .\
RESULTS	The contents of bone gla protein ( BGP ) , calcitonin ( CT ) , parathyroid hormone ( PTH ) and alkaline phosphatase ( AKP ) in the both groups had significant differences after treatment ( P < 0.05 , P < 0.01 ) ; 2 ) The content of estradiol ( E2 ) in serum in the both groups was decreased more obviously than those of normal women in reproductive age ( both P < 0.001 ) .\
RESULTS	The content of E2 in the both groups was obviously increased after treatment ( P < 0.05 , P < 0.01 ) , this function in the acupoint catgut implantation group was weaker than that of the medication group ( P < 0.05 ) , while the incidence rate of adverse effect in the acupoint catgut implantation group was lower than that of the medication group ( P < 0.05 ) ; 3 ) There were significant differences of the level of superoxide dismutase ( SOD ) and malondialdehyde ( MDA ) before and after treatment in the acupoint catgut implantation group , the level of SOD was obviously increased after treatment ( P < 0.01 ) , while the level of MDA decreased obviously ( P < 0.001 ) .\
CONCLUSIONS	Catgut implantation at acupoint can improve the low level of estrogen of postmenopausal women , with good safety .\
CONCLUSIONS	It can regulate the levels of bone metabolism and free radicals of postmenopausal women , so it is very meaningful to prevent and treat postmenopausal degenerative diseases including the osteoporosis and to delay the process of apolexis .\
\
###18515694\
OBJECTIVE	The identification of effective continuation and maintenance strategies for elderly patients with psychotic depression is a critical issue that has not been fully explored .\
OBJECTIVE	The aim of this study was to assess the tolerability and efficacy of continuation/maintenance electroconvulsive therapy ( ECT ) in elderly patients with psychotic depression after acute ECT remission .\
METHODS	The authors used a longitudinal , randomized , single-blind design to compare by survival analysis the 2-year outcome of two subgroups of elderly patients with psychotic unipolar depression who were ECT ( plus nortriptyline ) remitters .\
METHODS	One group was treated with a continuation/maintenance nortriptyline regimen ( N = 17 ) and the other with combined continuation/maintenance ECT plus nortriptyline ( N = 16 ) .\
RESULTS	Over 2 years of treatment in elderly , psychotic , unipolar depressed ECT ( plus nortriptyline ) remitters , the mean survival time was significantly longer in the combined ECT plus nortriptyline subgroup than in the nortriptyline subgroup .\
RESULTS	No differences were observed between treatments with regard to tolerability .\
CONCLUSIONS	This study supports the judicious use of combined continuation/maintenance ECT and antidepressant treatment in elderly patients with psychotic unipolar depression who are ECT remitters .\
\
###25227540\
BACKGROUND	Segmental muscle vibration ( SMV ) improves motor performances in neurological conditions , including stroke .\
OBJECTIVE	To determine if SMV modifies upper limb muscular activity in chronic stroke patients performing a reaching movement .\
METHODS	We randomized 22 chronic stroke patients to an experimental group ( EG ; n = 12 ) , receiving 10 sessions of exercise + 120 Hz SMV over the biceps brachii ( BB ) and the flexor carpi ulnaris ( FCU ) muscles , or to a control group ( CG ; n = 10 ) receiving exercise only .\
METHODS	All subjects performed a reaching movement with the affected side before and 4 weeks after therapy ended .\
METHODS	We recorded surface EMG activity of the anterior deltoid ( AD ) , posterior deltoid ( PD ) , BB , triceps brachii ( TB ) , FCU and extensor carpi radialis ( ECR ) muscles .\
METHODS	We calculated muscular onset times , modulation ratio , co-contractions and degree of contraction .\
RESULTS	After SMV , onset times of the PD ( p = 0.03 ) , BB ( p = 0.02 ) and ECR ( p = 0.04 ) in the EG were less anticipated than at baseline ; the modulation ratio increased in AD ( p = 0.003 ) and BB ( p = 0.01 ) ; co-contractions decreased in the pairs BB/TB ( p = 0.007 ) , PD/BB ( p = 0.004 ) and AD/BB ( p = 0.01 ) ; and the degree of contraction decreased in BB ( p = 0.01 ) .\
CONCLUSIONS	The modulation of muscular function induced by SMV may aid to explain its action on smoothness and coordination of movements .\
\
###21333015\
BACKGROUND	Depression is common and can have devastating effects on the life of adolescents .\
BACKGROUND	Psychological interventions are the first-line for treating or preventing depression among adolescents .\
BACKGROUND	This proposal aims to evaluate a school-based , universal psychological intervention to reduce depressive symptoms among student 's aged 13-14 attending municipal state secondary schools in Santiago , Chile .\
METHODS	This is a cluster randomised controlled trial with schools as the main clusters .\
METHODS	We compared this intervention with a control group in a study involving 22 schools , 66 classes and approximately 2,600 students .\
METHODS	Students in the active schools attended 11 weekly and 3 booster sessions of an intervention based on cognitive-behavioural models .\
METHODS	The control schools received their usual but enhanced counselling sessions currently included in their curriculum .\
METHODS	Mean depression scores and indicators of levels of functioning were assessed at 3 and 12 months after the completion of the intervention in order to assess the effectiveness of the intervention .\
METHODS	Direct and indirect costs were measured in both groups to assess the cost-effectiveness of this intervention .\
CONCLUSIONS	As far as we are aware this is the first cluster randomised controlled trial of a school intervention for depression among adolescents outside the Western world .\
BACKGROUND	ISRCTN19466209 .\
\
###25624390\
BACKGROUND	Studies suggest that giving newly born preterm infants sustained lung inflation ( SLI ) may decrease their need for mechanical ventilation ( MV ) and improve their respiratory outcomes .\
METHODS	We randomly assigned infants born at 25 weeks 0 days to 28 weeks 6 days of gestation to receive SLI ( 25 cm H2O for 15 seconds ) followed by nasal continuous positive airway pressure ( nCPAP ) or nCPAP alone in the delivery room .\
METHODS	SLI and nCPAP were delivered by using a neonatal mask and a T-piece ventilator .\
METHODS	The primary end point was the need for MV in the first 72 hours of life .\
METHODS	The secondary end points included the need for respiratory supports and survival without bronchopulmonary dysplasia ( BPD ) .\
RESULTS	A total of 148 infants were enrolled in the SLI group and 143 in the control group .\
RESULTS	Significantly fewer infants were ventilated in the first 72 hours of life in the SLI group ( 79 of 148 [ 53 % ] ) than in the control group ( 93 of 143 [ 65 % ] ) ; unadjusted odds ratio : 0.62 [ 95 % confidence interval : 0.38-0 .99 ] ; P = .04 ) .\
RESULTS	The need for respiratory support and survival without BPD did not differ between the groups .\
RESULTS	Pneumothorax occurred in 1 % ( n = 2 ) of infants in the control group compared with 6 % ( n = 9 ) in the SLI group , with an unadjusted odds ratio of 4.57 ( 95 % confidence interval : 0.97-21 .50 ; P = .06 ) .\
CONCLUSIONS	SLI followed by nCPAP in the delivery room decreased the need for MV in the first 72 hours of life in preterm infants at high risk of respiratory distress syndrome compared with nCPAP alone but did not decrease the need for respiratory support and the occurrence of BPD .\
\
###19231302\
BACKGROUND	Gastroscopy is sometimes associated with adverse cardiovascular events .\
OBJECTIVE	We evaluated the effects of sedation and pharyngeal anaesthesia on cardiac autonomic regulation during gastroscopy .\
METHODS	Two hundred thirteen outpatients undergoing gastroscopy .\
METHODS	The patients were assigned to 4 groups : ( 1 ) sedation with intravenous midazolam and placebo throat spray ( midazolam group ) , ( 2 ) placebo sedation and pharyngeal anaesthesia with lidocaine ( lidocaine group ) , ( 3 ) placebo sedation and placebo throat spray ( placebo group ) , and ( 4 ) no intravenous cannula nor throat spray ( control group ) .\
METHODS	Continuous electrocardiogram was recorded .\
METHODS	Heart rate variability was assessed ; the powers of low frequency ( 0.04-0 .15 Hz ) and high frequency ( 0.15-0 .40 Hz ) components as well as total power ( 0.0-0 .4 Hz ) were calculated .\
RESULTS	Gastroscopy was associated with a decrease in high frequency normalized units , increases in low frequency normalized units and low frequency/high frequency ratio indicating activation of sympathetic and withdrawal of vagal modulation .\
RESULTS	Sympathetic activation resulted in a decrease in total power and all components of heart rate variability .\
RESULTS	The decrease was most prominent in the midazolam treated patients ( p < 0.001 vs the lidocaine group and p < 0.01 vs placebo and control groups during the postendoscopy phase ) .\
CONCLUSIONS	Gastroscopy induces a shift towards dominance of the sympathetic modulation of the heart .\
CONCLUSIONS	Premedication with midazolam potentiates this shift .\
\
###20148254\
OBJECTIVE	Spinal saddle block represents nearly the ideal anaesthesia technique for anorectal surgery .\
OBJECTIVE	Post-dural puncture headache ( PDPH ) is a dreaded complication but can be decreased by the use of non-cutting spinal needles to rates less than 1 % .\
OBJECTIVE	Though , cutting Quincke type needles are still widely used for economic reasons , leading to a higher rate of PDPH .\
OBJECTIVE	We performed this study to demonstrate a reduction of PDPH by the use of very small 29-G compared with commonly used 25-G Quincke type spinal needles .\
METHODS	Two hundred sixteen adult patients ( male/female , 19-83 years , ASA status I-III ) were randomised 1:1 to groups , in which either a 25-G or a 29-G Quincke type spinal needle was used for a spinal saddle block .\
METHODS	The incidence of PDPH was assessed during 1 week after surgery .\
RESULTS	Thirty-nine of 216 patients developed PDPH but there was no difference between the two needle sizes ( 25-G , n = 18/106 vs. 29-G , n = 21/110 , p = 0.6870 ) .\
RESULTS	Women suffered significantly more from PDPH than men ( 23/86 vs. 16/130 , p = 0.0069 ) .\
RESULTS	Ambulatory patients had a later onset of PDPH than in-patients ( 24 h [ 0.5-72 ] vs. 2 h [ 0.2-96 ] , p = 0.0002 ) and the headache was more severe in these patients ( NRS 7 [ 2-10 ] vs. NRS 3 [ 1-8 ] , p = 0.0009 ) .\
CONCLUSIONS	The use of 29-G compared with 25-G Quincke needles led to no reduction of PDPH and is considerably higher compared with data from pencil-point needles .\
CONCLUSIONS	The use of non-cutting or pencil-point spinal needles should become the standard for performing spinal saddle block .\
\
###16635659\
BACKGROUND	Systemic sclerosis is a multisystemic connective tissue disease with marked involvement of the skin and joints for which few effective evidence based therapies are available .\
BACKGROUND	To further investigate the efficacy of extracorporeal photochemotherapy on early aggressive cutaneous disease , a randomized , double-blind , placebo-controlled trial was performed .\
OBJECTIVE	Our aim was to evaluate the efficacy of photopheresis in the treatment of patients with systemic sclerosis ( scleroderma ) .\
METHODS	This randomized , double-blind , placebo-controlled clinical trial was conducted at 16 investigational sites in the United States , Canada , and Europe .\
METHODS	Sixty-four patients with typical clinical and histologic findings of scleroderma , of less than 2 years ' duration , were studied .\
METHODS	Patients did not receive any other concomitant treatment for scleroderma .\
METHODS	Patients were randomized to receive either active or sham photopheresis treatment on two consecutive days monthly for 12 months .\
METHODS	Severity of skin ( skin scores assessed in 22 body regions ) and joint involvement ( 60 joints examined for contractures ) were assessed on a monthly basis .\
RESULTS	A statistically significant improvement in skin scores as compared with baseline was observed at 6 months ( P = .0024 ) and 12 months ( P = .008 ) among those who received active photopheresis , but not among those who received sham photopheresis .\
RESULTS	Comparison of skin scores between the two study arms did not achieve statistical significance because of the small sample size of the study arms .\
RESULTS	Joint involvement was also significantly improved after 6 months ( P = .002 ) and 12 months ( P = .001 ) of active photopheresis when compared with baseline .\
CONCLUSIONS	The study lacks sufficient statistical power to reveal a significant difference in skin and joint manifestations between the active and sham photopheresis arms .\
CONCLUSIONS	Photopheresis induced significant improvement of skin and joint involvement in patients with scleroderma of recent onset ; however , any effect when compared with sham treatment and a possible placebo effect may be modest .\
\
###11990437\
BACKGROUND	Many studies have observed damages to root surfaces treated by CO2 laser in continuous mode with a focused beam .\
BACKGROUND	The morphologic changes observed were always associated with temperature increase induced by high energy release .\
METHODS	The purpose of this study was to analyze by scanning electron microscopy ( SEM ) the effects of CO2 laser in 2 different modes on root surfaces .\
METHODS	Study samples consisted of 30 extracted single-rooted periodontally compromised human teeth .\
METHODS	Root specimens were randomly assigned to 3 groups : group A ( 12 ) treated with CO2 laser in continuous mode with a focused beam of 0.8 mm ; group B ( 12 ) treated with CO2 laser in pulsed mode with defocused beam of 4 mm ; and group C ( 6 ) , untreated controls .\
RESULTS	Group A ( continuous mode ) showed severe damages to dentin surfaces such as craters and fissures .\
RESULTS	Group B ( defocused mode ) did not result in any damages to the root surfaces , showing flat and smooth surfaces with apparent fusion of the smear layer and dentinal tubules almost completely sealed .\
RESULTS	The untreated control group was characterized by irregular and amorphous surfaces with several shallow depressions .\
CONCLUSIONS	Although both laser modes resulted in changes to the treated root surface specimens , the changes resulting in a smooth surface from use of defocused pulsed beam may present an advantage in periodontal treatment .\
\
###15598194\
OBJECTIVE	To assess whether receipt of primary medical care can lead to improved outcomes for adults with addictions .\
METHODS	We studied a prospective cohort of adults enrolled in a randomized trial to improve linkage with primary medical care .\
METHODS	Subjects at a residential detoxification unit with alcohol , heroin or cocaine as a substance of choice , and no primary medical care were enrolled .\
METHODS	Receipt of primary medical care was assessed over 2 years .\
METHODS	Outcomes included ( 1 ) alcohol severity , ( 2 ) drug severity and ( 3 ) any substance use .\
RESULTS	For the 391 subjects , receipt of primary care ( > or = 2 visits ) was associated with a lower odds of drug use or alcohol intoxication ( adjusted odds ratio ( AOR ) 0.45 , 95 % confidence interval ( CI ) 0.29-0 .69 , 2 d.f. chi ( 2 ) P = 0.002 ) .\
RESULTS	For 248 subjects with alcohol as a substance of choice , alcohol severity was lower in those who received primary care [ predicted mean Addiction Severity Index ( ASI ) alcohol scores for those reporting > or = 2 , 1 and 0 visits , respectively , 0.30 , 0.26 and 0.34 , P = 0.04 ] .\
RESULTS	For 300 subjects with heroin or cocaine as a substance of choice , drug severity was lower in those who received primary care ( predicted mean ASI drug scores for those reporting > or = 2 , 1 and 0 visits , respectively , 0.13 , 0.15 and 0.16 , P = 0.01 ) .\
CONCLUSIONS	Receipt of primary medical care is associated with improved addiction severity .\
CONCLUSIONS	These results support efforts to link patients with addictions to primary medical care services .\
\
###9403145\
OBJECTIVE	The hypotheses that automatic , non-volitional , attentional and memory biases for addiction-related constructs exist is tested with compulsive gamblers .\
METHODS	An independent groups design was employed .\
METHODS	Processing of gambling , compared to neutral and drug-related information was examined in 15 gamblers recruited from new members of Gamblers Anonymous .\
METHODS	Comparisons were made with the performance of their spouses ( N = 15 ) to help distinguish addiction mechanisms from more non-specific emotional experiences with gambling , and an independent control group ( N = 15 ) , recruited from the staff and students of a university department .\
METHODS	A modified Stroop procedure was first employed .\
METHODS	Automative cognitive interference was assessed relatively , by comparing colour-naming times on the gambling , drug and neutral Stroops .\
METHODS	A subsequent word-stem completion task of implicit memory was then used to assess selective and automatic priming of the gambling constructs in memory .\
RESULTS	Only the gamblers showed selective and automatic interference for gambling-related constructs on the Stroop task .\
RESULTS	Spouses behaved like the control group on this task .\
RESULTS	An implicit memory bias for gambling-related words was statistically detected only in the gamblers compared to the control group , although the trend was similar in the comparison with spouses .\
RESULTS	Further evidence for the specificity of these effects was obtained in subgroup comparisons involving fruit-machine with racing gamblers .\
CONCLUSIONS	Results are generally consistent with an automaticity in the cognitive biases gamblers show for gambling-related information .\
CONCLUSIONS	Implications for cognitive understanding and treatments are highlighted .\
\
###24102369\
BACKGROUND	Methyl aminolaevulinate photodynamic therapy ( MAL-PDT ) is an effective treatment for Bowen disease ( BD ) of the lower extremities .\
BACKGROUND	Er : YAG ( erbium : yttrium-aluminium-garnet ) ablative fractional laser ( AFL ) treatment removes the stratum corneum to increase MAL uptake and may improve efficacy .\
BACKGROUND	However , no studies have directly compared the efficacy of MAL-PDT with and without Er : YAG AFL therapy in treating BD of the lower extremities in Asians .\
OBJECTIVE	To compare the efficacy , recurrence rate , cosmetic outcomes and safety between Er : YAG AFL-assisted MAL-PDT ( Er : YAG AFL-PDT ) and standard MAL-PDT .\
METHODS	Twenty-one patients with a total of 58 BD lesions randomly received either one session of Er : YAG AFL-PDT or two sessions of MAL-PDT in two symmetrical areas .\
METHODS	Er : YAG AFL therapy was performed with 550-600 m ablation depth , level 1 coagulation , 22 % treatment density and a single pulse .\
METHODS	MAL cream was then applied under occlusion for 3 h and illuminated with a red light-emitting diode lamp at 37 J cm ( -2 ) .\
METHODS	A second session of MAL-PDT was administered 7 days later .\
METHODS	Overall response rate , recurrence rate , cosmetic outcomes and safety were assessed at 1 week , 3 and 12 months after treatment .\
RESULTS	After 3 months , Er : YAG AFL-PDT was significantly more effective ( 93.8 % ) than MAL-PDT ( 73.1 % ; P = 0.031 ) , and the recurrence rate was significantly lower for Er : YAG AFL-PDT ( 6.7 % ) than MAL-PDT ( 31.6 % ) at 12 months ( P = 0.022 ) .\
RESULTS	No significant difference was found between Er : YAG AFL-PDT and MAL-PDT in terms of cosmetic outcomes or safety .\
CONCLUSIONS	Er : YAG AFL-PDT showed significantly higher efficacy and lower recurrence rate than did standard MAL-PDT for treating lower extremity BD in an Asian population .\
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###23290985\
OBJECTIVE	To determine the efficacy and safety of different doses of secukinumab , a fully human monoclonal antibody for targeted interleukin-17A blockade , in patients with noninfectious uveitis .\
METHODS	Three multicenter , randomized , double-masked , placebo-controlled , dose-ranging phase III studies : SHIELD , INSURE , and ENDURE .\
METHODS	A total of 118 patients with Behet 's uveitis ( SHIELD study ) ; 31 patients with active , noninfectious , non-Behet 's uveitis ( INSURE study ) ; and 125 patients with quiescent , noninfectious , non-Behet 's uveitis ( ENDURE study ) were enrolled .\
METHODS	After an initial subcutaneous ( s.c. ) loading phase in each treatment arm , patients received s.c. maintenance therapy with secukinumab 300 mg every 2 weeks ( q2w ) , secukinumab 300 mg monthly ( q4w ) , or placebo in the SHIELD study ; secukinumab 300 mg q2w , secukinumab 300 mg q4w , secukinumab 150 mg q4w , or placebo in the INSURE study ; or secukinumab 300 mg q2w , secukinumab 300 mg q4w , secukinumab 150 mg q4w , or placebo in the ENDURE study .\
METHODS	Reduction of uveitis recurrence or vitreous haze score during withdrawal of concomitant immunosuppressive medication ( ISM ) .\
METHODS	Other end points included best-corrected visual acuity , ISM use ( expressed as a standardized ISM score ) , and safety outcomes .\
RESULTS	After completion or early termination of each trial , there were no statistically significant differences in uveitis recurrence between the secukinumab treatment groups and placebo groups in any study .\
RESULTS	Secukinumab was associated with a significant reduction in mean total post-baseline ISM score ( P = 0.019 ; 300 mg q4w vs. placebo ) in the SHIELD study .\
RESULTS	Likewise , secukinumab was associated with a greater median reduction in ISM score versus placebo in the INSURE study , although no statistical analysis of the difference was conducted because of the small sample size .\
RESULTS	Overall , there was no loss in visual acuity reported in any treatment group during follow-up in all 3 studies .\
RESULTS	According to descriptive safety statistics , the frequencies of ocular and nonocular adverse events seemed to be slightly higher among secukinumab groups versus placebo across the 3 studies .\
CONCLUSIONS	The primary efficacy end points of the 3 studies were not met .\
CONCLUSIONS	The secondary efficacy data from these studies suggest a beneficial effect of secukinumab in reducing the use of concomitant ISM .\
\
###17823740\
OBJECTIVE	Thermodilution ( TD ) is the `` gold standard method '' for hemodynamic monitoring .\
OBJECTIVE	Some parameters can be measured by Oesophageal Doppler ( OD ) , which is simpler and less invasive .\
OBJECTIVE	To evaluate the accuracy of OD , we compared this method with TD in measurement of cardiac output ( CO ) .\
METHODS	One hundred and ninety two simultaneous measurements were made in 10 patients ( 5 male and 5 female ) with different clinical situations , 8 with sepsis using vasoactive drugs and 2 monitored for laryngectomy and liver transplantation .\
METHODS	Measurements were taken during 4 hours at 30 minute intervals .\
METHODS	The two oesophageal dopplers used DeltexR and ArrowR , were introduced between 35 and 45 cm from the nose and located at the point of largest diameter of the descending aorta .\
METHODS	In TD , we used the pulmonary artery catheter ( Swan Ganz BaxterR ) and the DX - 2001 monitorR positioning was confirmed with support of radiology and of pressures curves .\
METHODS	Measurements of CO carried out by means of TD were achieved using an iced saline solution considering the mean of four measurements with less than a 5 % difference .\
METHODS	The statistical method used was the Bland-Altman scatter plot and dispersion graphic .\
RESULTS	No statistically significant difference was found between the two methods for hemodyamic measurement with a correlation coefficient of 0.8 for CO ( Deltex DopplerR and Baxter Swan GanzR ) and a correlation coefficient of 0.99 for CO ( Arrow DopplerR and Baxter Swan GanzR ) .\
CONCLUSIONS	Homodynamic measurements with OD have the same accuracy as those with TD and were easily obtained in the 10 patients .\
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###10404946\
BACKGROUND	The flavonoid components of tea have been associated in epidemiological studies with a decreased risk of cardiovascular disease .\
BACKGROUND	Flavonoids have been shown to have antioxidant and vasodilator effects in vitro ; we therefore postulated that drinking green or black tea attenuates the well-characterized acute pressor response to caffeine and lowers blood pressure during regular consumption .\
OBJECTIVE	To determine whether green and black tea can attenuate the transient pressor effect of caffeine , or lower blood pressure during regular consumption .\
METHODS	In the first study , the acute effects of four hot drinks - green tea and black tea ( at a dose equivalent to four standard cups ) , water matched to the teas for caffeine content ( ` caffeine ' ) and water - were assessed in 20 normotensive men using a Latin-Square designed study .\
METHODS	Clinic blood pressure was measured before and 30 and 60 min after each drink had been ingested .\
METHODS	In the second study , the effects on blood pressure of regular green and black tea ingestion were examined in 13 subjects with high-normal systolic blood pressure and mild systolic hypertension ( systolic blood pressure in the range 130-150 mmHg ) using a three-period crossover study .\
METHODS	Five cups per day of green tea , black tea and caffeine ( in hot water and matched to the teas ) were consumed for 7 days each , in random order .\
METHODS	Twenty-four hour ambulatory blood pressure was measured at the end of each seven-day intervention .\
METHODS	Results are presented as means and 95 % confidence intervals ( CI ) .\
RESULTS	An acute pressor response to caffeine was observed .\
RESULTS	Relative to caffeine , there were further acute increases in systolic and diastolic blood pressure at 30 min among those drinking green tea [ 5.5 mmHg ( 95 % CI -1.4 to 12.4 ) and 3.1 mmHg ( 95 % CI -0.1 to 6.3 ) , respectively ] and black tea [ 10.7 mmHg ( 95 % CI 4.0 to 17.4 ) and 5.1 mmHg ( 95 % CI 1.8 to 8.4 ) , respectively ] .\
RESULTS	The changes in blood pressure at 60 min were not significant The effect on 24-h ambulatory systolic and diastolic blood pressure of regular drinking of green tea [ increases of 1.7 mmHg ( 95 % CI -1.6 to 5.0 ) and 0.9 mmHg ( 95 % CI -1.3 to 3.1 ) , respectively ] or black tea [ increase of 0.7 mmHg ( 95 % CI -2.6 to 4.0 ) and decrease of 0.7 mmHg ( 95 % CI -2.9 to 1.5 ) , respectively ] was not significant relative to caffeine .\
CONCLUSIONS	Contrary to our initial hypothesis , tea ingestion caused larger acute increases in blood pressure than caffeine alone .\
CONCLUSIONS	However , any acute effects of tea on blood pressure did not translate into significant alterations in ambulatory blood pressure during regular tea consumption .\
\
###7759724\
OBJECTIVE	This study was performed to test the safety and efficacy of a novel bioabsorbable hemostatic puncture closure device deployed through an arterial sheath .\
BACKGROUND	Cardiac catheterization procedures are associated with a risk of complications at the arterial access site .\
BACKGROUND	Increasing numbers of interventional procedures requiring large sheaths or intense anticoagulation underline the need for secure , rapid methods of obtaining hemostasis at the time of sheath removal .\
METHODS	We conducted a randomized , multicenter trial in 435 patients undergoing cardiac catheterization or angioplasty at eight participating centers .\
METHODS	In 218 patients , hemostasis was achieved using the device ( group I ) ; 217 patients were assigned to the manual pressure control group ( group II ) .\
RESULTS	There were no significant differences in baseline characteristics .\
RESULTS	Time to hemostasis was considerably shorter in group I ( 2.5 + / - 15.2 vs. 15.3 + / - 11.7 min [ mean + / - SD ] , p < 0.0001 ) .\
RESULTS	The deployment success rate for the device was 96 % , and 76 % of group I patients experienced immediate ( within 1 min ) hemostasis .\
RESULTS	Complication rates were lower in group I for bleeding , hematoma and occurrence of any complication .\
RESULTS	There was no difference in the small incidence of pseudoaneurysm formation .\
RESULTS	There was no change in either group in the ankle/brachial systolic blood pressure index .\
RESULTS	Ultrasound follow-up studies 60 days after device deployment revealed complete absorption of the device in all cases .\
RESULTS	Subgroup analysis revealed particular benefit in patients undergoing interventional procedures .\
RESULTS	The administration of heparin was associated with a significantly higher complication rate in the manual pressure control group , whereas heparin had no effect on hemostasis time or complication rates in the device group .\
CONCLUSIONS	This sheath-deployed , bioabsorbable device provides a safe and effective means of obtaining rapid arterial hemostasis after cardiac catheterization procedures .\
CONCLUSIONS	It appears to be particularly useful in those patients most at risk for access site complications .\
\
###21514678\
BACKGROUND	Tonsillar hypertrophy contributes to pediatric disorders , including obstructive sleep apnea .\
BACKGROUND	The goal was to determine the utility of digital photographs for pediatric tonsillar grading .\
METHODS	Using Brodsky 's grading scale , 41 children ( 3.0-14 .6 years ) had in-person tonsil grading during a routine pediatric ENT physical examination .\
METHODS	Oral photographs were obtained with a standard single-lens reflex digital camera and graded by the same ENT physician and by an independent Pediatrician .\
RESULTS	In-person and photograph gradings were highly correlated , but also differed significantly .\
RESULTS	Yet photograph gradings did not differ between physicians , suggesting that photographs provide unique , consistent information to different clinicians .\
RESULTS	Discrepancies between in-person and photograph gradings were not explained by child age .\
CONCLUSIONS	Static images may provide experts more time for mental calculations and may therefore provide a superior estimation of tonsil size .\
CONCLUSIONS	Photographs should be considered for remote use , as well as a potentially better alternative to current in vivo estimates .\
\
###17509313\
OBJECTIVE	Exposure to the microgravity environment of space increases the risk of kidney stone formation , particularly for calcium oxalate and uric acid stones .\
OBJECTIVE	This study was performed to evaluate the efficacy of potassium alkali as potassium-magnesium citrate in reducing renal stone risk and bone turnover .\
METHODS	This study was performed as a double-blind , placebo controlled trial .\
METHODS	We studied 20 normocalciuric subjects randomized to either placebo or potassium-magnesium citrate ( 42 mEq potassium , 21 mEq magnesium , 63 mEq citrate per day ) before and during 5 weeks of strict bed rest .\
METHODS	The study was performed in the General Clinical Research Center and under a controlled dietary regimen composed of 100 mEq of sodium , 800 mg of calcium , 0.8 gm/kg animal protein and 2,200 kcal per day .\
METHODS	Two 24-hour urine collections were obtained under oil each week for assessment of stone risk parameters and relative saturation of calcium oxalate , brushite and undissociated uric acid .\
METHODS	Blood was also collected for determination of serum immunoreactive parathyroid hormone and vitamin D metabolites .\
RESULTS	Bed rest promoted a rapid increase in urinary calcium excretion of approximately 50 mg per day in both groups .\
RESULTS	Despite this increase subjects treated with potassium-magnesium citrate demonstrated significant decreases in the relative saturation of calcium oxalate and in the concentration of undissociated uric acid compared to placebo .\
RESULTS	Immunoreactive parathyroid hormone , serum 1,25-dihydroxyvitamin D and intestinal calcium absorption all decreased in both groups with no difference in response between the 2 treatment arms .\
CONCLUSIONS	Provision of alkali as potassium-magnesium citrate is an effective countermeasure for the increased risk of renal stone disease associated with immobilization .\
CONCLUSIONS	Despite an increase in urine calcium concentration , the relative saturation of calcium oxalate decreased due to citrate chelation of calcium and the concentration of undissociated uric acid decreased due to the significant increase in urine pH.\
\
###11053174\
OBJECTIVE	To test the hypothesis that a community based intervention by secondary child and adolescent mental health services would be significantly more effective and less costly than a hospital based intervention .\
METHODS	Open study with two randomised parallel groups .\
METHODS	Two health districts in the north of England .\
METHODS	Parents of 3 to 10 year old children with behavioural disorder who had been referred to child and adolescent mental health services .\
METHODS	Parental education groups .\
METHODS	Parents ' and teachers ' reports of the child 's behaviour , parental depression , parental criticism of the child , impact of the child 's behaviour on the family .\
RESULTS	141 subjects were randomised to community ( n = 72 ) or hospital ( n = 69 ) treatment .\
RESULTS	Primary outcome data were obtained on 115 ( 82 % ) cases a year later .\
RESULTS	Intention to treat analyses showed no significant differences between the community and hospital based groups on any of the outcome measures , or on costs .\
RESULTS	Parental depression was common and predicted the child 's outcome .\
CONCLUSIONS	Location of child mental health services may be less important than the range of services that they provide , which should include effective treatment for parents ' mental health problems .\
\
###17567306\
BACKGROUND	Breast cancer is the most common cancer in women and therefore represents a major problem in public health .\
BACKGROUND	Data from patients ' self-report questionnaires provide valuable information about the side-effects that patients may view as having a significantly detrimental impact on their quality of life ( QOL ) and yet are not always recognized as important by healthcare professionals .\
BACKGROUND	Cosmetology is a specific care for patients and there is actually no scientific evidence regarding effects on QOL for women with breast cancer .\
OBJECTIVE	The purpose of this study is to assess the impact of cosmetic care on QOL in breast cancer patients during chemotherapy and radiotherapy .\
METHODS	We developed a prospective , multicentre , randomized , controlled study including 27 patients .\
METHODS	All the patients had to fill in a French-validated dermatologic specific quality-of-life questionnaire to compare the QOL of the two groups , the cosmetic group and the control group , at three different times of the adjuvant treatment .\
RESULTS	The results show a statistically significant difference between the cosmetic group and the control group in two areas of QOL : mood state and self-perception of the disease .\
CONCLUSIONS	This study emphasizes the interest of cosmetic care in breast cancer patients .\
CONCLUSIONS	However , further larger trials are needed to confirm this study .\
\
###16424446\
BACKGROUND	Patients who fail noninvasive ventilation are generally intubated and are then subjected to complications of invasive mechanical ventilation .\
BACKGROUND	With transtracheal open ventilation , ventilator support is delivered through an uncuffed small bore minitracheostomy tube , which eliminates pooling of secretions above the cuff and thus reduces the risk of tracheobronchial microbial colonization .\
OBJECTIVE	To compare transtracheal open ventilation ( treatment group ) with conventional invasive ventilation ( control group ) in patients with exacerbation of chronic obstructive pulmonary disease who initially failed noninvasive ventilation .\
METHODS	Patients were randomized to receive trans-tracheal open ventilation ( n = 19 ) or conventional invasive ventilation ( n = 20 ) .\
RESULTS	There was no difference in arterial blood gases after 1 and 30 h between the two groups .\
RESULTS	Two patients receiving transtracheal open ventilation and 13 undergoing conventional ventilation had complications ( p < 0.0001 ) .\
RESULTS	Compared with conventional ventilation , transtracheal open ventilation significantly decreased both the duration of mechanical ventilation ( 7.6 + / -4.7 vs. 18.6 + / -10.6 d , p < 0.0001 ) and length of stay in the intensive care unit ( 10.2 + / -4.5 vs. 21.3 + / -9.7 d , p < 0.0001 ) .\
CONCLUSIONS	Transtracheal open ventilation was as effective as conventional ventilation in maintaining adequate gas exchange and reducing complications , duration of mechanical ventilation , and intensive care unit length of stay .\
\
###23672380\
BACKGROUND	Instruction can be used to alter the biomechanical movement patterns associated with anterior cruciate ligament ( ACL ) injuries .\
OBJECTIVE	To determine the effects of instruction through combination ( self and expert ) feedback or self-feedback on lower extremity kinematics during the box-drop-jump task , running-stop-jump task , and sidestep-cutting maneuver over time in college-aged female athletes .\
METHODS	Randomized controlled clinical trial .\
METHODS	Laboratory .\
METHODS	Forty-three physically active women ( age = 21.47 1.55 years , height = 1.65 0.08 m , mass = 63.78 12.00 kg ) with no history of ACL or lower extremity injuries or surgery in the 2 months before the study were assigned randomly to 3 groups : self-feedback ( SE ) , combination feedback ( CB ) , or control ( CT ) .\
METHODS	Participants performed a box-drop-jump task for the pretest and then received feedback about their landing mechanics .\
METHODS	After the intervention , they performed an immediate posttest of the box-drop-jump task and a running-stop-jump transfer test .\
METHODS	Participants returned 1 month later for a retention test of each task and a sidestep-cutting maneuver .\
METHODS	Kinematic data were collected with an 8-camera system sampled at 500 Hz .\
METHODS	The independent variables were feedback group ( 3 ) , test time ( 3 ) , and task ( 3 ) .\
METHODS	The dependent variables were knee - and hip-flexion , knee-valgus , and hip - abduction kinematics at initial contact and at peak knee flexion .\
RESULTS	For the box-drop-jump task , knee - and hip-flexion angles at initial contact were greater at the posttest than at the retention test ( P < .001 ) .\
RESULTS	At peak knee flexion , hip flexion was greater at the posttest than at the pretest ( P = .003 ) and was greater at the retention test than at the pretest ( P = .04 ) ; knee valgus was greater at the retention test than at the pretest ( P = .03 ) and posttest ( P = .02 ) .\
RESULTS	Peak knee flexion was greater for the CB than the SE group ( P = .03 ) during the box-drop-jump task at posttest .\
RESULTS	For the running-stop-jump task at the posttest , the CB group had greater peak knee flexion than the SE and CT ( P .05 ) .\
CONCLUSIONS	Our results suggest that feedback involving a combination of self-feedback and expert video feedback with oral instruction effectively improved lower extremity kinematics during jump-landing tasks .\
\
###18179510\
BACKGROUND	Individuals with Intellectual Disability ( ID ) exhibit reduced levels of compliance to exercise , including treadmill walking .\
BACKGROUND	The purpose of this study was to measure the effects of several training conditions on compliance to participation in treadmill walking of children with moderate to severe ID .\
METHODS	Criteria for compliance were the averaged number of times participants attempted to discontinue walking during two 5-min exercise sessions of treadmill walking at an intensity of 65-75 % of predicted maximal HR .\
METHODS	Fifteen children aged 5-11 with moderate to severe ID participated in the study .\
METHODS	Training conditions were ( a ) close supervisor 's position , ( b ) distant supervisor 's position , ( c ) positive reinforcement , and ( d ) paired modeling .\
RESULTS	General linear mixed model statistics revealed significant differences in favor of the paired modeling and positive reinforcement compared to the other conditions .\
RESULTS	Leaning forward was the most frequent type of participants ' attempt to stop exercising .\
CONCLUSIONS	Paired modeling and positive reinforcement should be considered within treadmill training programs for children with moderate to severe ID .\
\
###22617015\
BACKGROUND	Mesalazine ( mesalamine ) granules ( MG ) were shown to be effective for the maintenance of remission of ulcerative colitis ( UC ) in two double-blind placebo-controlled trials .\
OBJECTIVE	To evaluate the efficacy of once-daily MG for maintenance of remission in patients with UC who switched from other 5-aminosalicylic acid ( 5-ASA ) formulations .\
METHODS	Data from two independent multicenter , randomised , double-blind , placebo-controlled , 6-month trials evaluating patients with UC in remission were combined for analysis of a subpopulation of patients who switched from other 5-ASA formulations to MG 1.5 g or placebo upon randomisation .\
METHODS	The primary endpoint was the percentage of patients who remained relapse-free at Month 6 or end of treatment .\
METHODS	Relapse was defined as a Sutherland Disease Activity Index ( SDAI ) rectal bleeding score 1 and mucosal appearance score 2 , a UC flare or medication used to treat a UC flare .\
RESULTS	Of the 487 patients who received 5-ASA maintenance therapy at enrolment , 322 were in the MG group and 165 were in the placebo group .\
RESULTS	The percentage of patients who remained relapse-free ( based on Sutherland Disease Activity Index scores ) after 6 months was significantly higher with MG than placebo ( 78.3 % vs. 58.8 % , P < 0.001 ) .\
RESULTS	Rectal bleeding , stool frequency and the physician 's rating of disease activity remained unchanged after 6 months in a higher percentage of patients using MG compared with those on placebo ( P < 0.004 for each endpoint ) .\
CONCLUSIONS	Mesalazine granules 1.5 g once-daily is effective for maintenance of remission in UC patients who switch from other 5-ASA formulations .\
CONCLUSIONS	ClinicalTrials.gov identifiers NCT00744016 , NCT00767728 .\
\
###20717066\
OBJECTIVE	We prospectively investigated the efficacy of an external pancreatic duct stent to prevent pancreatic fistula in the nonfibrotic pancreas after pancreaticojejunostomy , in which the degree of pancreatic fibrosis was assessed objectively by using dynamic magnetic resonance imaging ( MRI ) .\
METHODS	Among the 67 consecutive patients who underwent pancreatic head resection , 45 patients were judged to have a normal pancreas without fibrosis based on the preoperative assessment of pancreatic fibrosis based on MRI .\
METHODS	The patients were randomly allocated to 1 of 2 groups with ( n = 23 ) or without ( n = 22 ) use of an external pancreatic duct stent in performing a pancreaticojejunostomy .\
RESULTS	Pancreatic fistula developed in 8 ( 34.5 % ) patients in the stented group : 3 grade A and 5 grade B ; whereas in the nonstented group , 9 ( 40.9 % ) patients developed pancreatic fistula : 3 grade A and 6 grade B.\
RESULTS	There were no significant differences in the incidence or severity of pancreatic fistula between the 2 groups .\
CONCLUSIONS	The utility of the external pancreatic duct stent after pancreaticojejunostomy was not found in the nonfibrotic pancreases , which were sorted according to the degree of pancreatic fibrosis using the pancreatic time-signal intensity curve analysis from MRI .\
\
###22089958\
OBJECTIVE	Vestibular rehabilitation strategies mostly require a long-lasting training in stance conditions , which is finally not always successful .\
OBJECTIVE	The individualized training in everyday-life conditions with an intuitive tactile neurofeedback stimulus seems to be a more promising approach .\
OBJECTIVE	Hence , the present study was aimed at investigating the efficacy of a new vibrotactile neurofeedback system for vestibular rehabilitation .\
METHODS	Double-blinded trial .\
METHODS	One hundred five patients who experience one of the following balance disorders for more than 12 months were included in the study : canal paresis , otolith disorder , removal of an acoustic neuroma , microvascular compression syndrome , Parkinson 's disease , and presbyvertigo .\
METHODS	Vibrotactile neurofeedback training was performed daily ( 15 min ) over 2 weeks with the Vertiguard system in those 6 tasks of the Standard Balance Deficit Test with the most prominent deviations from the normative values .\
METHODS	Trunk and ankle sway , dizziness handicap inventory , and vestibular symptom score were measured in the verum and placebo group before the training , on the last training day and 3 months later .\
RESULTS	A significant reduction in trunk and ankle sway as well as in the subjective symptom scores were observed in the verum group .\
RESULTS	Such an effect could not be found in any of the outcome parameters of the placebo group .\
CONCLUSIONS	The vibrotactile neurofeedback training applied in the present study is a highly efficient method for the reduction of body sway in different balance disorders .\
CONCLUSIONS	Because the rehabilitation program is easy to perform , not exhausting , and time saving , elderly patients and those with serious , long-lasting balance problems also can participate successfully .\
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###10399514\
BACKGROUND	Many complications were reported to be related with nasotracheal intubation .\
BACKGROUND	Various chemical or mechanical techniques have been proposed to decrease hemorrhage and trauma associated with nasotracheal intubation but the results remain controversial .\
BACKGROUND	We conducted a prospective , randomized , single-blind study to elucidate the effect of an endotracheal tube softened with warm water before use on the incidence and severity of epistaxis following nasotracheal intubation .\
METHODS	Sixty-two healthy , ( ASA class I or II ) patients scheduled for elective surgery were randomly assigned into two groups .\
METHODS	Patients in the treatment group were intubated with a softened endotracheal tube made possible by heating it in warm water while those in the control group were intubated with unsoftened ( intact ) tube .\
METHODS	Epistaxis was evaluated immediately after intubation and its severity was graded as none , mild , moderate and severe .\
METHODS	The use of Magill forceps and postoperative nasal morbidity were also recorded .\
RESULTS	The total incidence of epistaxis in the `` unsoftened '' group was significantly higher than that of `` softened '' group ( 76.7 % vs. 43.8 % , P = 0.0002 ) .\
RESULTS	The severity of nasal hemorrhage was also significantly lightened in the `` softened '' group .\
RESULTS	No technical difficulty was encountered in intubation with a softened endotracheal tube by prewarming .\
RESULTS	The morbidity referable to nasal intubation , however , did not differ in both groups .\
CONCLUSIONS	In conclusion , our study shows that using an endotracheal tube softened by warm water could reduce the incidence and severity of epistaxis during the act of nasotracheal intubation .\
CONCLUSIONS	It is an effective way and worth a try .\
\
###21246846\
OBJECTIVE	To compare the short and long-term therapeutic effects on cervical spondylotic radiculopathy ( CSR ) treated with simple Long 's bone-setting manipulation , abdominal acupuncture and abdominal acupuncture plus Long 's bone-setting manipulation .\
METHODS	One hundred and eighty cases of CSR were randomly allocated into abdominal acupuncture plus bone-setting group ( combined therapy group ) , bone-setting group and abdominal acupuncture group , 60 cases in each group .\
METHODS	In combined therapy group , the abdominal acupuncture and Long 's bone-setting were applied in combination .\
METHODS	Abdominal acupuncture was applied to Zhongwan ( CV 12 ) , Guanyuan ( CV 4 ) , Shiguan ( KI 18 ) , Shangqu ( KI 17 ) , etc. .\
METHODS	Long 's manipulation , such as bone-setting in head-upward posture and bone-setting in head-lateral posture , was adopted .\
METHODS	In bone-setting group and abdominal acupuncture group , Long 's bone-setting manipulation and abdominal acupuncture were adopted simply and respectively .\
METHODS	The clinical therapeutic effects were compared after 2 courses of treatment ( short-term ) and 1-month after treatment ( long-term ) among groups .\
RESULTS	The short and long-term curative and markedly effective rates in combined therapy group were 80.7 % ( 46/57 ) and 68.4 % ( 39/57 ) respectively , which were better than those of 63.64 % ( 35/55 ) , 30.9 % ( 17/55 ) in bone-setting group and 58.9 % ( 33/56 ) , 50.0 % ( 28/56 ) in abdominal acupuncture group , separately ( all P < 0.05 ) .\
RESULTS	Moreover , the long-term curative and markedly effective rate in abdominal acupuncture group was superior to that in bone-setting group ( P < 0.05 ) .\
CONCLUSIONS	Abdominal acupuncture plus Long 's bone-setting manipulation has significant efficacy of either short or long-term on CSR , which is superior to the efficacy of either simple abdominal acupuncture or Long 's bone-setting manipulation and indicates superimposed effect .\
CONCLUSIONS	Hence , it is one of the better approaches in CSR treatment .\
\
###15541126\
OBJECTIVE	To assess if a short course of antibiotics starting at the time of the removing a short-term urethral catheter decreases the incidence of subsequent urinary tract infection ( UTI ) .\
METHODS	Patients across specialities with a urethral catheter in situ for > / = 48 h and < / = 7 days were recruited at the time of catheter removal .\
METHODS	Patients were excluded if they had had recent genitourinary surgery or were on antibiotics .\
METHODS	Eligible patients were randomly assigned to a 48-h course of either ciprofloxacin or placebo tablets starting 2 h before catheter removal .\
METHODS	A catheter specimen of urine was obtained before the start of the trial medication .\
METHODS	The follow-up was at 7 and 14 days after catheter removal , with a questionnaire for UTI symptoms , and a mid-stream urine sample was taken .\
RESULTS	Forty-eight patients were recruited and had a complete follow-up ( 25 received ciprofloxacin and 23 placebo ) .\
RESULTS	Of the ciprofloxacin group , four patients ( 16 % ) had a UTI at the follow-up after catheter removal , and two were symptomatic .\
RESULTS	The UTI in two patients ( including one of those symptomatic ) was newly developed after catheter removal ; the other two UTIs were a result of failure to resolve a catheter-associated UTI .\
RESULTS	All these UTIs in the ciprofloxacin group were resistant to ciprofloxacin .\
RESULTS	Of the placebo group , three patients ( 13 % ) had a UTI at the follow-up after removal , and one patient was symptomatic .\
RESULTS	The UTI , newly developed after catheter removal , was resistant to ciprofloxacin .\
RESULTS	The other two patients were asymptomatic ; their UTIs were a result of failure to resolve a catheter-associated UTI , and one was resistant to ciprofloxacin .\
CONCLUSIONS	The risk of UTI ( both symptomatic and asymptomatic ) after removing a urethral catheter is real , even in absence of catheter-associated UTI before removal .\
CONCLUSIONS	UTIs occurring after removing a short-term urinary catheter had a high rate of resistance to ciprofloxacin .\
CONCLUSIONS	There was no detectable significant benefit in using prophylactic ciprofloxacin to reduce the UTI rate after catheter removal .\
\
###11578885\
OBJECTIVE	To compare clinical conditions in patients sedated with propofol or remifentanil during combined peri-bulbar and retrobulbar block ( PRBB ) for cataract surgery .\
METHODS	Prospective , randomized , double-blind study .\
METHODS	Private clinic .\
METHODS	106 ASA physical status I and II patients scheduled for cataract surgery .\
METHODS	Patients were randomized to receive either 0.5 mg/kg propofol ( Group P ) or 0.3 microg/kg remifentanil ( Group R ) as an intravenous ( IV ) bolus 1 minute prior to PRBB .\
METHODS	At the same time , patients in both groups also received 0.5 to 1 mg midazolam IV .\
METHODS	Movement of the hands , arms , head , and eyes were counted during each stage of the procedure by an observer who was blinded to the sedation used .\
METHODS	Heart rate ( HR ) , blood pressure ( BP ) , respiratory rate ( RR ) , expiratory CO ( 2 ) ( PECO ( 2 ) ) , and hemoglobin oxygen saturation ( SaO ( 2 ) ) were recorded every minute for 10 minutes after the PRBB .\
METHODS	Anesthetic complications , recall , and the pain experienced with the block and surgery were compared between the two groups .\
METHODS	Means and variance of the results were compared with one-way analysis of variance and Fisher 's exact test .\
RESULTS	Movements of the hands , arms , and head were significantly greater in Group P during all stages of the block .\
RESULTS	Almost no movements were recorded in the remifentanil group .\
RESULTS	Immediately after the PRBB ( 1 to 6 min ) , HRs were higher in Group P ( 73 + / - 11 bpm vs. 67 + / - 10 bpm ; p = 0.0075 ) , whereas the RRs were slower in Group R for the period 1 to 5 minutes after the PRBB ( 16 + / - 5 breaths/min vs. 14 + / - 4 breaths/min ; p = 0.0206 ) .\
RESULTS	At these times , the mean PECO ( 2 ) was higher in Group R ( 36 + / - 7 mmHgvs .\
RESULTS	32 + / - 9 mmHg ; p = 0.0125 ) .\
RESULTS	Nineteen patients in the propofol group sneezed during the medial peribulbar injection compared with none in the remifentanil group .\
RESULTS	Anesthetic and surgical complications were unremarkable and similar for the two groups .\
CONCLUSIONS	Respiratory depression with remifentanil was mild and not clinically significant .\
CONCLUSIONS	Remifentanil sedation for this application was superior to sedation with propofol .\
\
###8690630\
OBJECTIVE	A controversy exists regarding whether it is safe to delay radiation therapy until the completion of chemotherapy following breast-conserving surgery for patients with node-positive breast cancer .\
OBJECTIVE	Within the context of two concurrent randomized clinical trials we had the opportunity to evaluate outcomes for patients who received breast irradiation after completing different durations of chemotherapy .\
METHODS	From July 1986 to April 1993 the International Breast Cancer Study Group ( IBCSG ) Trial VI randomly assigned 1554 pre/perimenopausal node-positive breast cancer patients to receive cyclophosphamide , methotrexate , and 5-fluorouracil ( CMF ) for either three consecutive courses on months 1-3 , or six consecutive courses on months 1-6 , both with or without reintroduction CMF .\
METHODS	IBCSG Trial VII randomly assigned 1266 postmenopausal node-positive breast cancer patients to receive tamoxifen for 5 years , or tamoxifen for 5 years with three early cycles of CMF , both with or without three courses of delayed CMF .\
METHODS	Both trials allowed a choice of mastectomy , or breast-conserving surgery plus radiation therapy , and both were stratified by type of surgery .\
METHODS	Radiotherapy was delayed until the initial block of CMF was completed ; 4 or 7 months after surgery for pre/perimenopausal patients , and 2 or 4 months after surgery for postmenopausal patients .\
METHODS	Over both trials , 718 eligible patients elected to receive breast-conserving surgery plus radiation therapy : 433 on Trial VI , and 285 on Trial VII .\
METHODS	Four-year actuarial total failure rates ( failure at any site ) , risks of developing distant metastases ( DM at any time during observation ) , and overall survival ( OS ) were estimated using the Kaplan-Meier method .\
METHODS	To avoid potential bias due to competing causes of failure , only patients who could be followed for at least 4 years ( enrolled prior to July 1 , 1990 ) were used to evaluate the patterns of first relapse site .\
METHODS	Crude percents of local failure with or without other sites ( LF ) , distant metastases including regional nodal failure ( DM/RNF ) , or other first events ( second primaries/death without recurrence ) were estimated for each treatment group .\
METHODS	For this report , an intent to treat analysis was performed at a median follow-up of 48 months .\
RESULTS	No differences were found in the 4-year actuarial total failure rates , risk of developing distant metastases , and overall survival among the two radiotherapy groups of each study .\
RESULTS	The cumulative incidence of types of first failure and the 4-year crude rates showed no treatment differences in the patterns of site of first event .\
RESULTS	Estimates for the 4-year crude percent of local failures were 8 and 9 % for pre/perimenopausal patients who had radiation therapy at 4 or 7 months after surgery , and 3 and 6 % for postmenopausal patients who had radiation therapy at 2 months or 4 months after surgery .\
CONCLUSIONS	For node positive patients receiving breast-conserving surgery followed by radiation therapy , the incidence of breast recurrence in the conserved ipsilateral breast within 4 years was between 8 and 9 % for pre/perimenopausal patients and between 3 and 6 % for postmenopausal patients .\
CONCLUSIONS	After 48 months of median follow-up , administering radiation therapy after three or six cycles of CMF for pre/perimenopausal women , or after no cycles or three cycles of CMF for postmenopausal women does not influence overall efficacy or local control in this series .\
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###17439735\
BACKGROUND	Surgical treatment options for patients with cirrhosis and portal hypertension are complicated .\
BACKGROUND	In this study , we evaluated the effectiveness of a new treatment strategy , splenic auto-transplantation and oesophageal transection anastomosis .\
BACKGROUND	We report results from clinical observations , splenic immune function and portal dynamics in 274 patients .\
METHODS	From 1979 to 2005 , 274 cirrhosis patients with portal hypertension underwent the new treatment strategy , and were followed up to compare results with those patients who underwent traditional surgical treatment .\
METHODS	From 1999 to 2002 , a randomized controlled trial ( RCT ) was performed on 40 patients to compare their post-operative immune function .\
METHODS	From 1994 to 2006 , another RCT enrolled 28 patients to compare portal dynamics using three-dimensional dynamic contrast-enhanced magnetic resonance angiography ( 3D DEC MRA ) investigation post operation .\
RESULTS	Among 274 patients ( mean age 41.8 years ) , the emergency operative mortality ( 4.4 % ) , selective operative mortality ( 2.2 % ) , complication rate ( 17.9 % ) , prevalence of hepatic encephalopathy ( < 1 % ) , rate of portal hypertension gastritis ( PHG ) bleeding ( 9.1 % ) , and morbidity of hepatic carcinoma ( 8 % ) were similar to those patients undergoing traditional operation ; the spleen immunology function ( Tuftsin , IgM ) decreased in both groups 2 months post operation , but this decrease did not reach statistical significance .\
RESULTS	Through 3D DCE MRA , the cross sectional area and the velocity and volume of blood flow of the main portal vein decreased significantly after operation in both groups .\
RESULTS	The velocity and volume of blood flow in the auto-transplantation group was significantly lower than that in the control group .\
CONCLUSIONS	Splenic auto-transplantation and esophageal transection anastomosis is a safe , effective , and reasonable treatment strategy for patients with portal hypertension with varicial bleeding .\
CONCLUSIONS	It not only can correct hypersplenism , but may also achieve complete hemostasis .\
CONCLUSIONS	Spleens auto-transplanted into the retroperitoneal space can preserve immune function and establish broad collateral circulation .\
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###19818062\
OBJECTIVE	Overactive bladder syndrome ( OAB ) is a urinary condition that often exerts detrimental effects on an individual 's quality of life ( QoL ) .\
OBJECTIVE	A once-daily , extended-release ( ER ) formulation of the quaternary amine trospium chloride has recently been developed for the treatment of OAB .\
OBJECTIVE	The pooled health-related QoL ( HRQoL ) data from two multicenter , parallel-group , double-blind Phase III studies with trospium chloride ER 60 mg were analyzed .\
METHODS	Subjects aged > or = 18 years with urinary urgency , frequency , and an average of > or = 1 urge urinary incontinence episode per day on a 3-day bladder diary were randomized ( 1:1 ) to receive once-daily trospium 60 mg ER or placebo for 12 weeks .\
METHODS	HRQoL was assessed at baseline and at Week 12 using the King 's Health Questionnaire ( KHQ ) and the OAB questionnaire ( OAB-q ) .\
RESULTS	Overall , 1165 subjects were randomized ( trospium ER , n = 578 ; placebo , n = 587 ) .\
RESULTS	Trospium ER produced significantly greater improvements from baseline than placebo in seven of the nine KHQ domains .\
RESULTS	At Week 12 , the improvement in mean OAB-q HRQoL total score ( from approximately 52 at baseline ) was significantly greater with trospium ER than with placebo ( +25.8 vs. +20.7 ; P = 0.0003 ) .\
RESULTS	Improvements from baseline were seen with trospium ER on all eight of the OAB-q symptom bother scales .\
CONCLUSIONS	Once-daily trospium 60 mg ER improved the QoL of subjects with OAB , as assessed using the KHQ and the OAB-q , in two large Phase III clinical trials .\
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###20363764\
OBJECTIVE	To evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy undergoing percutaneous coronary intervention ( PCI ) .\
RESULTS	Five hundred and three patients on > 10 days clopidogrel therapy ( 41 % with non-ST-segment elevation acute coronary syndrome , ACS ) randomly received 600 mg clopidogrel loading 4-8 h before PCI ( n = 252 ) or placebo ( n = 251 ) .\
RESULTS	Primary endpoint was 30-day incidence of major adverse cardiac events ( MACE ) .\
RESULTS	In the overall population primary endpoint occurred in 6.7 % of patients in the reload vs. 8.8 % in the placebo arm [ odds ratios ( OR ) 0.75 , 95 % confidence intervals ( CI ) 0.37-1 .52 ; P = 0.50 ] .\
RESULTS	In stable angina patients , 1-month MACE were not significantly different ( 7.0 vs. 3.9 % ; OR 1.84 , 0.60-5 .88 ; P = 0.36 ) , whereas ACS patients had significant clinical benefit with reloading ( 6.4 vs. 16.3 % ; OR 0.34 , 95 % CI 0.32-0 .90 , P = 0.033 at multivariable analysis ; interaction test : P = 0.01 ) .\
RESULTS	There was no excess bleeding in the reload arm ( 6 % in both groups ) .\
CONCLUSIONS	ARMYDA-4 RELOAD reveals no overall benefit from reloading patients on chronic clopidogrel therapy prior to PCI ; the benefit observed in ACS patients is a hypothesis-generating finding that needs to be confirmed by larger studies .\
\
###21883811\
OBJECTIVE	A double-blind randomized controlled study was conducted to compare the effect of magnesium oxide ( 1 g 12-h ) with placebo given within an evidence-based multimodal rehabilitation programme on gastrointestinal recovery , pain , mobilization and hospital stay after open colonic resection .\
METHODS	Of 62 potentially eligible patients , 13 were excluded , leaving 22 in the magnesium oxide group and 27 in the placebo group .\
METHODS	The main outcome measure was time to normalization of bowel function .\
METHODS	Secondary outcome measures included postoperative nausea , vomiting , pain , fatigue , mobilization and length of postoperative hospital stay .\
RESULTS	The median times to first flatus and defaecation in the laxative and placebo groups were 18.0 vs 14.0 h and 42 vs 50 h ( P > 0.15 ) .\
RESULTS	Early intake of liquids , protein drinks and solid food , nausea and vomiting , pain , fatigue and mobilization were similar in the groups ( P > 0.3 ) .\
RESULTS	The median postoperative hospital stay was 3 days in both groups ( P > 0.65 ) .\
CONCLUSIONS	Magnesium oxide does not enhance the recovery of gastrointestinal function within the context of an evidence-based multimodal rehabilitation programme after open colonic surgery .\
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###23253886\
BACKGROUND	We hypothesised , that perioperative use of N ( 2 ) - L-alanyl-L-glutamine confers cardioprotection and improves insulin resistance in diabetic patients with coronary artery disease operated under cardiopulmonary bypass .\
METHODS	This double-blind , placebo-controlled , randomised study included 64 patients with diabetes mellitus type 2 who were scheduled for on-pump coronary artery bypass graft surgery .\
METHODS	The protocol group ( 32 patients ) and the control group ( 32 patients ) glutamine ( 0.4 g/kg/day of 20 % solution of N ( 2 ) - L-alanyl-L-glutamine ( `` Dipeptiven ( ) '' Fresenius Kabi , Germany ) ) and placebo ( 0.9 % NaCl ) , respectively .\
METHODS	Perioperative concentration of troponin I in plasma was considered as the primary end-point .\
METHODS	Whereas the secondary end-points were insulin resistance , insulin sensitivity , - cell function , blood glucose , plasma triglycerides and free fatty acids concentrations .\
METHODS	Insulin resistance , insulin sensitivity and - cell function were measured using HOMA equation .\
METHODS	Thermodilution method was used to measure haemodynamics in all the patients .\
RESULTS	No differences have been found in perioperative dynamics of troponin I , insulin resistance , insulin sensitivity , - cell function , blood glucose , plasma triglycerides free fatty acids concentrations and haemodynamics .\
CONCLUSIONS	Our results have failed to confirm the cardioprotective properties and modulatory effect on perioperative insulin resistance that are thought to be attributable to parenteral glutamine administration in dose 0.4 g/kg/day among cardiac patients with DM operated on under CPB .\
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###20304772\
OBJECTIVE	Although cross-sectional studies have demonstrated poor adherence to airway clearance therapy ( ACT ) for patients with cystic fibrosis ( CF ) , no studies have identified longitudinal patterns of adherence .\
OBJECTIVE	The objective was to characterize and identify predictors of ACT adherence trajectories for individuals with CF.\
METHODS	Secondary data analyses were conducted for a randomized clinical trial examining differences in three ACTs .\
METHODS	Participants ( n = 153 ; M = 14.3 years , 55 % male , 86 % Caucasian , baseline FEV ( 1 ) % predicted : M = 86.7 ) / primary caregivers completed Daily Phone Diaries , an empirically supported adherence measure , every 4 months .\
RESULTS	Group-based trajectory modeling revealed the best-fitting solution was a three-group model : low-adherence ( 14 % ) , medium-adherence ( 49 % ) , and high-adherence ( 37 % ) groups .\
RESULTS	ACT type was the only significant predictor of adherence trajectories .\
CONCLUSIONS	Three trajectories of adherence to ACT for patients with CF were found .\
CONCLUSIONS	With the identification of trajectories , adherence interventions can be targeted for the subgroup at highest risk in order to prevent poor health outcomes .\
\
###16080791\
BACKGROUND	In persons without clinical symptom it is difficult to assess an impact of probiotics regarding its effect on health .\
BACKGROUND	We evaluated the functional efficacy of the probiotic Lactobacillus fermentum ME-3 in healthy volunteers by measuring the influence of two different formulations on intestinal lactoflora , fecal recovery of the probiotic strain and oxidative stress markers of blood and urine after 3 weeks consumption .\
METHODS	Two 3-week healthy volunteer trials were performed .\
METHODS	Open placebo controlled ( OPC ) study participants ( n = 21 ) consumed either goat milk or by L. fermentum ME-3 fermented goat milk ( daily dose 11.8 log CFU ( Colony Forming Units ) .\
METHODS	Double blind randomised placebo controlled ( DBRP ) study participants ( n = 24 ) received either capsules with L. fermentum ME-3 ( daily of dose 9.2 CFU ) or placebo capsules .\
METHODS	The faecal lactoflora composition , faecal ME-3 recovery , effect of the consumption on intestinal lactoflora , and oxidative stress markers of blood ( total antioxidative activity ; total antioxidative status and glutathione red-ox ratio ) was measured .\
RESULTS	ME-3 was well tolerated and a significant increase in total faecal lactobacilli yet no predominance of ME-3 was detected in all study groups .\
RESULTS	Faecal recovery of ME-3 was documented by molecular methods only in fermented milk group , however the significant improvement of blood TAA ( Total Antioxidative Activity ) and TAS ( Total Antioxidative Status ) indices was seen both in case of fermented goat milk and capsules '' , yet glutathione re-ox ratio values decreased only in case of fermented by ME-3 goat milk .\
CONCLUSIONS	The functional efficacy of both consumed formulations of an antioxidative probiotic L. fermentum ME-3 is proved by the increase of the intestinal lactobacilli counts providing putative defence against enteric infections and by reduction of the oxidative stress indices of blood and urine of healthy volunteers .\
CONCLUSIONS	In non-diseased host the probiotic health claims can be assessed by improvement of some measurable laboratory indices of well-established physiological functions of host , e.g. markers of antioxidative defence system .\
\
###21776573\
BACKGROUND	Several previous studies have demonstrated that bone mineral density loss around femoral implants is common , particularly in the proximal part of the femur , soon after total hip arthroplasty .\
BACKGROUND	The purpose of the present study was to compare the effects of alendronate and alfacalcidol on bone mineral density loss around the femoral implant and in the lumbar spine after total hip arthroplasty .\
METHODS	The present study included sixty patients with osteoarthritis of the hip who had undergone a primary cementless total hip arthroplasty .\
METHODS	We assigned these individuals to treatment with alendronate ( n = 20 ) , alfacalcidol ( n = 18 ) , or no medication ( n = 22 ) .\
METHODS	Periprosthetic and lumbar spine bone mineral density was measured one week after surgery , and biochemical markers ( bone-specific alkaline phosphatase and serum N-terminal telopeptides of type-1 collagen ) were measured before surgery as a reference baseline .\
METHODS	Subsequent measurements were performed at twelve , twenty-four , and forty-eight weeks after surgery .\
METHODS	The periprosthetic measurement area in the femur was defined as Regions 1 to 7 , which are consecutively located around the implant from the greater trochanter to the lesser trochanter and calcar .\
RESULTS	Bone mineral density in the alendronate group was maintained in all regions .\
RESULTS	In the alfacalcidol and no-medication groups , bone mineral density in Region 7 was lower than in Regions 3 to 6 throughout the study period ( p < 0.0001 as a result of repeated measures analysis of variance ) .\
RESULTS	Bone mineral density in the lumbar spine in the alendronate and alfacalcidol groups was higher than in the no-medication group at forty-eight weeks .\
RESULTS	The serum level of N-terminal telopeptides of type-1 collagen in the alendronate group was lower than that in the no-medication group throughout the study period ( p = 0.003 , 0.02 and 0.005 ) .\
CONCLUSIONS	Alendronate prevented bone mineral density loss around femoral implants , particularly in Region 7 ( calcar ) , but alfacalcidol did not show any effects in any regions .\
CONCLUSIONS	However , bone mineral density losses in the lumbar spine were effectively prevented by either alendronate or alfacalcidol .\
\
###21470283\
BACKGROUND	It is unclear whether recombinant human growth hormone ( rhGH ) improves linear growth in children with Crohn 's disease ( CD ) .\
OBJECTIVE	To investigate the effects of rhGH on height velocity ( HV ) and glucose homeostasis over a 6-month period .\
METHODS	Randomized controlled trial in two tertiary children 's hospitals in 22 children with inflammatory bowel disease amongst whom 21 had CD .\
METHODS	Duration of disease from diagnosis and number of acute relapses requiring either exclusive enteral nutrition or therapeutic dose of oral prednisolone were similar in the treatment and control groups .\
METHODS	Either rhGH ( 0067 mg/kg per day ) as daily subcutaneous injections ( rhGH group ; n , 11 ) or no rhGH , ( Ctrl ; n , 11 ) for 6 months .\
METHODS	Percentage change in HV after 6 months in the two groups .\
METHODS	Auxology , puberty , skeletal age , disease factors , treatment and glucose homeostasis were also assessed .\
RESULTS	Median HV increased from 45 ( range , 06 , 89 ) at baseline to 108 ( 61 , 150 ) cm/year at 6 month ( P = 0003 ) in the rhGH group , whereas in the Ctrl group , it was 38 ( 14 , 67 ) and 35 cm/year ( 20 , 96 ) , respectively ( P = 058 ) .\
RESULTS	Median percentage increase in HV after 6 months in the rhGH group was 140 % ( 167 , 9167 ) compared with 174 % ( -421 % , 977 % ) in the Ctrl group ( P < 0001 ) .\
RESULTS	There were no significant differences in disease activity and proinflammatory cytokines at baseline and 6 months in both groups and change in bone age for chronological age was also similar in the two groups .\
RESULTS	In the rhGH group , fasting insulin increased from 40 ( 20 , 110 ) to 70 mU/l ( 20 , 160 ) ( P = 002 ) , whereas in the Ctrl group , it was 30 ( 12 , 127 ) and 38 mU/l ( 21 , 70 ) ( P = 072 ) , respectively .\
CONCLUSIONS	Although this pilot trial shows that rhGH can improve short-term linear growth in children with CD , the clinical efficacy of this therapy needs to be further studied in longer-term studies of growth , glucose homeostasis and disease status .\
\
###23733781\
OBJECTIVE	To investigate the prognostic value of minimal residual disease ( MRD ) assessment in patients with multiple myeloma treated in the MRC ( Medical Research Council ) Myeloma IX trial .\
METHODS	Multiparameter flow cytometry ( MFC ) was used to assess MRD after induction therapy ( n = 378 ) and at day 100 after autologous stem-cell transplantation ( ASCT ; n = 397 ) in intensive-pathway patients and at the end of induction therapy in non-intensive-pathway patients ( n = 245 ) .\
RESULTS	In intensive-pathway patients , absence of MRD at day 100 after ASCT was highly predictive of a favorable outcome ( PFS , P < .001 ; OS , P = .0183 ) .\
RESULTS	This outcome advantage was demonstrable in patients with favorable and adverse cytogenetics ( PFS , P = .014 and P < .001 , respectively ) and in patients achieving immunofixation-negative complete response ( CR ; PFS , P = .0068 ) .\
RESULTS	The effect of maintenance thalidomide was assessed , with the shortest PFS demonstrable in those MRD-positive patients who did not receive maintenance and longest in those who were MRD negative and did receive thalidomide ( P < .001 ) .\
RESULTS	Further analysis demonstrated that 28 % of MRD-positive patients who received maintenance thalidomide became MRD negative .\
RESULTS	MRD assessment after induction therapy in the non-intensive-pathway patients did not seem to be predictive of outcome ( PFS , P = .1 ) .\
CONCLUSIONS	MRD assessment by MFC was predictive of overall outcome in patients with myeloma undergoing ASCT .\
CONCLUSIONS	This predictive value was seen in patients achieving conventional CR as well as patients with favorable and adverse cytogenetics .\
CONCLUSIONS	The effects of maintenance strategies can also be evaluated , and our data suggest that maintenance thalidomide can eradicate MRD in some patients .\
\
###11396815\
BACKGROUND	Vitamin A is important for protection against diarrhea , and supplements may benefit gut function of infants of HIV-infected mothers .\
METHODS	We studied 238 infants of HIV-infected South African women participating in a randomized , double-blind , placebo-controlled trial of vitamin A during pregnancy ( 1.5 mg retinyl palmitate and 30 mg beta-carotene daily ) plus 60 mg retinyl palmitate at delivery .\
METHODS	The placebo group received identical placebo capsules at the same times .\
METHODS	When infants were 1 , 6 , and 14 weeks of age , lactulose/mannitol dual sugar intestinal permeability tests were performed .\
RESULTS	Maternal vitamin A supplementation did not significantly affect infant gut permeability in the group as a whole at any time .\
RESULTS	By multiple regression analysis , HIV infection of the infant by 14 weeks was significantly associated with increased gut permeability at both 6 and 14 weeks .\
RESULTS	After controlling for birth weight , gestational age , current weight , feeding mode and recent morbidity , there was a trend toward an interaction between vitamin A supplementation and HIV infection ( P = 0.086 ) at 14 weeks .\
RESULTS	Vitamin A made no difference to gut permeability of uninfected infants ( lactulose/mannitol ratio for vitamin A group : 0.11 , 95 % confidence interval [ CI ] 0.08 , 0.15 , n = 73 and for placebo group : 0.09 , 95 % CI 0.06 , 0.12 , n = 76 ) , but largely prevented the increase in the ratio of HIV-infected infants ( vitamin A group : 0.17 , 95 % CI 0.13 , 0.23 , n = 23 ; placebo group : 0.50 , 95 % CI 0.37 , 0.68 , n = 20 ) .\
RESULTS	The effects on the lactulose/mannitol ratio were related to changes in lactulose , not mannitol , excretion .\
RESULTS	Vitamin A supplementation was associated with significantly lower lactulose excretion at 1 and 14 weeks , suggesting the major effect of vitamin A was on maintaining the integrity of gut tight junctions .\
CONCLUSIONS	Vitamin A supplementation of HIV-infected pregnant women may prevent the deterioration in gut integrity in the subgroup of their infants who themselves become infected .\
CONCLUSIONS	Improving vitamin A status of HIV-infected infants may decrease their gastrointestinal morbidity .\
\
###20035347\
OBJECTIVE	The aim of this work is to analyze , by means of noninvasive monitoring , the clinical effects of high intraperitoneal pressure for enough time to insert the first trocar .\
METHODS	Sixty-seven patients without significant lung problems were randomly divided into groups P12 ( n = 30 , maximum intraperitoneal pressure 12 mmHg ) and P20 ( n = 37 , maximum intraperitoneal pressure 20 mmHg ) .\
METHODS	A Veress needle was inserted into the left hypochondrium for creation of pneumoperitoneum .\
METHODS	The parameters evaluated were heart rate ( HR , in bpm ) , arterial oxygen saturation ( SaO ( 2 ) , expressed as percentage of hemoglobin saturated with oxygen ) , end-tidal CO ( 2 ) ( ETCO ( 2 ) , in mmHg ) , mean arterial pressure ( MAP , in mmHg ) , and intratracheal pressure ( ITP , in cmH ( 2 ) O ) .\
METHODS	Clinical parameters were evaluated in both groups at time point 0 ( TP0 , before CO ( 2 ) insufflation ) , time point 1 ( TP1 , when intraperitoneal pressure of 12 mmHg was reached in both groups ) , time point 2 ( TP2 , 5 min after reaching intraperitoneal pressure of 12 mmHg in group P12 and of 20 mmHg in group P20 ) , and time point 3 ( TP3 , 10 min after reaching intraperitoneal pressure of 12 mmHg in group P12 and 10 min after TP1 in group P20 , when intraperitoneal pressure decreased from 20 to 12 mmHg ) .\
METHODS	Values outside of the normal range or occurrence of atypical phenomena suggestive of organic disease indicated clinical changes .\
RESULTS	Statistically significant differences were observed between the two groups regarding HR , MAP , ETCO ( 2 ) , and ITP .\
RESULTS	No significant clinical changes were observed .\
CONCLUSIONS	Transitory , high intraperitoneal pressure ( 20 mmHg for 5 min ) for insertion of the first trocar resulted in changes in HR , MAP , ETCO ( 2 ) , and ITP that were within the normal range , and no adverse clinical effects were observed .\
CONCLUSIONS	Therefore , the use of transitory , high intraperitoneal pressure is recommended to prevent iatrogenic injury during blind insertion of the first trocar .\
CONCLUSIONS	Nevertheless , it is not clear that this method would be safe in patients with moderate to severe chronic obstructive pulmonary disease .\
\
###11919489\
OBJECTIVE	To determine the association of cytomegalovirus ( CMV ) viremia with mortality and CMV retinitis progression in newly diagnosed and relapsed CMV retinitis .\
METHODS	Ancillary study of a randomized , placebo-controlled , phase III clinical trial .\
METHODS	A total of 83 patients with AIDS and CMV retinitis , enrolled during the first phase of the Monoclonal Antibody Cytomegalovirus Retinitis Trial , were administered MSL-109 or placebo as adjuvant therapy for CMV retinitis .\
METHODS	Mortality and CMV retinitis progression .\
RESULTS	Treatment with MSL-109 did not predict either progression of CMV retinitis or mortality .\
RESULTS	Detection in plasma CMV DNA at baseline predicted mortality , but CMV antigenemia did not .\
RESULTS	CMV DNA was a better predictor of mortality than a high HIV viral load .\
RESULTS	Neither CMV DNA nor antigenemia predicted the progression of CMV retinitis .\
RESULTS	Among newly diagnosed patients , there was a decline in the proportion with detectable CMV viral load and CMV antigenemia in response to anti-CMV therapy .\
RESULTS	However , there was a rebound in CMV viral load to 25 % and CMV antigenemia to 54.6 % at 6 months .\
RESULTS	In relapsed patients , anti-CMV therapy was not associated with a change in the percentage with detectable CMV-DNA or CMV antigenemia over time .\
CONCLUSIONS	In patients with AIDS and CMV retinitis , the detection of plasma CMV DNA was associated with a higher risk of mortality than was a high HIV viral load .\
CONCLUSIONS	Anti-CMV therapy provided a transient reduction in CMV viremia in newly diagnosed but not relapsed patients with CMV retinitis .\
CONCLUSIONS	Adjuvant therapy with MSL-109 was ineffective in clearing CMV-DNA and CMV antigen from the plasma .\
\
###16936184\
BACKGROUND	Aromatase inhibitors are widely employed in the adjuvant treatment of early stage breast cancer .\
BACKGROUND	The impact of aromatase inhibitors has not been established in ethnic minority women .\
METHODS	The purpose of this study was to evaluate the impact of letrozole on minority women in MA .17 , a placebo-controlled trial of letrozole following 5 years of tamoxifen in postmenopausal women with early stage breast cancer .\
METHODS	Retrospective comparison of disease-free survival ( DFS ) , side effects , and mean changes in quality of life ( QOL ) scores from baseline between Caucasian and minority women was performed .\
RESULTS	Minority ( n = 352 ) and Caucasian ( n = 4708 ) women were analyzed .\
RESULTS	There was no difference between these groups in DFS ( 91.6 % versus 92.4 % respectively for 4 year DFS ) .\
RESULTS	Letrozole , compared with placebo , significantly improved DFS for Caucasians ( HR = 0.55 ; P < 0.0001 ) but not for minorities ( HR = 1.39 ; P = 0.53 ) .\
RESULTS	Among women who received letrozole , minorities had a significantly lower incidence of hot flashes ( 49 % versus 58 % ; P = 0.02 ) , fatigue ( 29 % versus 39 % ; P = 0.005 ) , and arthritis ( 2 % versus 7 % ; P = 0.006 ) compared with Caucasians .\
RESULTS	Mean change in QOL scores for minority women who received letrozole demonstrated improved mental health at the 6-month assessment ( P = 0.02 ) and less bodily pain at the 12-month assessment ( P = 0.046 ) .\
CONCLUSIONS	Letrozole improved DFS in Caucasians but a definite benefit in minority women has not yet been demonstrated .\
CONCLUSIONS	Minority women tolerated letrozole better than Caucasians in terms of toxicity .\
CONCLUSIONS	These results need confirmation in other trials of aromatase inhibitors .\
\
###24403557\
BACKGROUND	Clade B DNA and recombinant modified vaccinia Ankara ( MVA ) vaccines producing virus-like particles displaying trimeric membrane-bound envelope glycoprotein ( Env ) were tested in a phase 2a trial in human immunodeficiency virus ( HIV ) - uninfected adults for safety , immunogenicity , and 6-month durability of immune responses .\
METHODS	A total of 299 individuals received 2 doses of JS7 DNA vaccine and 2 doses of MVA/HIV62B at 0 , 2 , 4 , and 6 months , respectively ( the DDMM regimen ) ; 3 doses of MVA/HIV62B at 0 , 2 , and 6 months ( the MMM regimen ) ; or placebo injections .\
RESULTS	At peak response , 93.2 % of the DDMM group and 98.4 % of the MMM group had binding antibodies for Env .\
RESULTS	These binding antibodies were more frequent and of higher magnitude for the transmembrane subunit ( gp41 ) than the receptor-binding subunit ( gp120 ) of Env .\
RESULTS	For both regimens , response rates were higher for CD4 ( + ) T cells ( 66.4 % in the DDMM group and 43.1 % in the MMM group ) than for CD8 ( + ) T cells ( 21.8 % in the DDMM group and 14.9 % in the MMM group ) .\
RESULTS	Responding CD4 ( + ) and CD8 ( + ) T cells were biased toward Gag , and > 70 % produced 2 or 3 of the 4 cytokines evaluated ( ie , interferon , interleukin 2 , tumor necrosis factor , and granzyme B ) .\
RESULTS	Six months after vaccination , the magnitudes of antibodies and T-cell responses had decreased by < 3-fold .\
CONCLUSIONS	DDMM and MMM vaccinations with virus-like particle-expressing immunogens elicited durable antibody and T-cell responses .\
\
###21318559\
OBJECTIVE	Pilot study to compare the effect of inhaled nitric oxide ( iNO ) and aerosolized iloprost in preventing perioperative pulmonary hypertensive crises ( PHTCs ) .\
BACKGROUND	Guidelines recommend the use of iNO to treat PHTCs , but treatment with iNO is not an ideal vasodilator .\
BACKGROUND	Aerosolized iloprost may be a possible alternative to iNO in this setting .\
METHODS	Investigator-initiated , open-label , randomized clinical trial in 15 infants ( age range 77-257days ) with left-to-right shunt ( 11 out of 15 with additional trisomy 21 ) , and pulmonary hypertension ( i.e. mean pulmonary artery pressure [ PAP ] > 25mmHg ) after weaning from cardiopulmonary bypass .\
METHODS	Patients were randomized to treatment with iNO at 10ppm or aerosolized iloprost at 0.5 g/kg ( every 2h ) .\
METHODS	The observation period was 72h after weaning from cardiopulmonary bypass .\
METHODS	The primary endpoint was the occurrence of PHTCs ; the secondary endpoints were mean PAP , duration of mechanical ventilation , safety of administration , and in-hospital mortality .\
RESULTS	Seven patients received iNO and eight patients received iloprost .\
RESULTS	During the observation period , 13 of the 15 patients had at least one major or minor PHTC .\
RESULTS	There was no difference between the groups with regard to the frequency of PHTCs , mean PAP and duration of mechanical ventilation ( p > 0.05 ) .\
CONCLUSIONS	In this pilot study , aerosolized iloprost had a favorable safety profile .\
CONCLUSIONS	Larger trials are needed to compare its efficacy to iNO for the treatment of perioperative pulmonary hypertension .\
CONCLUSIONS	However , neither treatment alone abolished the occurrence of PHTCs .\
\
###26158926\
OBJECTIVE	To compare aqueous humor pH values in patients during femtosecond laser-assisted cataract surgery with patients during conventional phacoemulsification .\
METHODS	A prospective clinical study was conducted in 29 eyes of 29 patients who underwent cataract surgery by a single surgeon .\
METHODS	The femtosecond laser group included 15 eyes operated on with a femtosecond laser platform ( Catalys ; Abbott Medical Optics , Santa Ana , CA ) and the phacoemulsification group included 14 eyes that were operated on with conventional phacoemulsification .\
METHODS	The femtosecond laser group was subdivided into low , medium , and high level of cavitation gas bubbles after docking and the femtosecond laser procedure , according to the judgment of the surgeon .\
METHODS	Aqueous humor samples ( 0.10 to 0.15 mL ) were collected through a paracentesis from each patient after docking , corneal incisions , and nucleus fragmentation in the femtosecond laser group and after corneal incisions but before injection of viscoelastic in the phacoemulsification group , then analyzed with a pH meter .\
RESULTS	The mean pH was 6.53 0.09 ( range : 6.42 to 6.70 ) and 7.42 0.07 ( range : 7.28 to 7.48 ) in the femtosecond laser and phacoemulsification groups , respectively ( P < .001 ) .\
RESULTS	In the femtosecond laser group , no significant differences in pH were observed between the three subgroups after docking and the femtosecond laser surgical procedure : low ( 6.55 0.09 [ range : 6.53 to 6.57 ] ) , medium ( 6.54 0.07 [ range : 6.52 to 6.55 ] ) , and high ( 6.42 0.00 [ range : 6.40 to 6.44 ] ) level of gas bubbles .\
CONCLUSIONS	Cavitation bubbles derived from the photodisruption process in femtosecond laser-assisted cataract surgery lead to an acidic shift of the aqueous humor pH as a result of the transformation of carbon dioxide to carbonic acid .\
CONCLUSIONS	The level of gas bubbles visible after the laser photodisruption does not seem to correlate with this pH shift .\
CONCLUSIONS	Further analysis of femtosecond laser-assisted cataract surgery is necessary .\
\
###10639540\
BACKGROUND	Observational and experimental studies suggest that the amount of vitamin E ingested in food and in supplements is associated with a lower risk of coronary heart disease and atherosclerosis .\
METHODS	We enrolled a total of 2545 women and 6996 men 55 years of age or older who were at high risk for cardiovascular events because they had cardiovascular disease or diabetes in addition to one other risk factor .\
METHODS	These patients were randomly assigned according to a two-by-two factorial design to receive either 400 IU of vitamin E daily from natural sources or matching placebo and either an angiotensin-converting-enzyme inhibitor ( ramipril ) or matching placebo for a mean of 4.5 years ( the results of the comparison of ramipril and placebo are reported in a companion article ) .\
METHODS	The primary outcome was a composite of myocardial infarction , stroke , and death from cardiovascular causes .\
METHODS	The secondary outcomes included unstable angina , congestive heart failure , revascularization or amputation , death from any cause , complications of diabetes , and cancer .\
RESULTS	A total of 772 of the 4761 patients assigned to vitamin E ( 16.2 percent ) and 739 of the 4780 assigned to placebo ( 15.5 percent ) had a primary outcome event ( relative risk , 1.05 ; 95 percent confidence interval , 0.95 to 1.16 ; P = 0.33 ) .\
RESULTS	There were no significant differences in the numbers of deaths from cardiovascular causes ( 342 of those assigned to vitamin E vs. 328 of those assigned to placebo ; relative risk , 1.05 ; 95 percent confidence interval , 0.90 to 1.22 ) , myocardial infarction ( 532 vs. 524 ; relative risk , 1.02 ; 95 percent confidence interval , 0.90 to 1.15 ) , or stroke ( 209 vs. 180 ; relative risk , 1.17 ; 95 percent confidence interval , 0.95 to 1.42 ) .\
RESULTS	There were also no significant differences in the incidence of secondary cardiovascular outcomes or in death from any cause .\
RESULTS	There were no significant adverse effects of vitamin E.\
CONCLUSIONS	In patients at high risk for cardiovascular events , treatment with vitamin E for a mean of 4.5 years had no apparent effect on cardiovascular outcomes .\
\
###15160519\
BACKGROUND	Antibiotic prophylaxis in transurethral resection of the prostate is a regular practice in urology .\
BACKGROUND	However , its prophylactic effect can be questioned when the antiseptic surgical technique is used .\
BACKGROUND	Nonetheless , urine culture-oriented antibiotic therapy is the gold standard for avoiding improper medication usage and bacterial resistance .\
OBJECTIVE	To study the efficacy of antibiotic usage in patients with negative urine cultures , who were submitted to transurethral resection of the prostate .\
METHODS	Prospective open labeled study .\
METHODS	Tertiary care referral hospital .\
METHODS	124 consecutive patients , who were randomly divided into two groups to receive antibiotic prophylaxis or not .\
METHODS	Cultures from meatus , urine , irrigation and antiseptic fluid , and prostate tissue chips , were compared and analyzed for bacterial sensitivity to the antibiotic used , according to the surgeon 's personal criteria .\
METHODS	McLennan 's test was used for statistical analysis .\
RESULTS	No statistically significant difference regarding clinical evolution was found between the groups that received or antibiotics or not .\
RESULTS	Statistical significance was found regarding the occurrence of positive urine cultures during the postoperative period for those not receiving antibiotics , but not in relation to fever , prostate chip culture or bacteremic episodes .\
RESULTS	Sixty-eight subjects ( 57.1 % ) presented positive prostatic tissue culture .\
RESULTS	There was no specific correlation between the recovered bacteria from the meatus , prostatic tissue chip and urine and the spectrum of the administered antibiotic .\
RESULTS	Six cases showed the same bacteria in the urine and prostatic tissue chip .\
RESULTS	Only fifteen cases ( 25 % ) in the antibiotic group showed the desired sensitivity directed to the collected bacteria .\
CONCLUSIONS	Antibiotic prophylaxis for patients whose urine is sterile is debatable in patients who are candidates for transurethral resection of the prostate .\
CONCLUSIONS	Most of the time , the antibiotic agent used is not specific for any of the bacteria recovered from the various sources analyzed .\
\
###17012640\
OBJECTIVE	A randomized controlled trial to compare 2 forms of monophasic pulsed currents with 2 forms of burst-modulated , kilohertz-frequency alternating current ( `` Russian current '' and `` Aussie current '' ) was conducted to establish whether different amounts of wrist extensor torque were produced and whether discomfort varied with stimulus type .\
METHODS	The 32 subjects were adults who were healthy and were drawn from a population of staff and students at La Trobe University .\
METHODS	Each subject received all 4 currents .\
METHODS	Maximal electrically induced torque ( MEIT ) of the wrist extensors was measured for each stimulus type .\
METHODS	Relative discomfort of stimulation also was assessed .\
RESULTS	Russian current elicited lower mean torque than those elicited by Aussie current and monophasic pulsed currents .\
RESULTS	The Russian and Aussie currents elicited significantly less discomfort than the 2 monophasic pulsed currents .\
CONCLUSIONS	When force production and relative discomfort were jointly used as the criteria , Aussie current was found to be more effective than either of the monophasic pulsed currents or Russian current stimulation .\
\
###12588573\
OBJECTIVE	To evaluate the effectiveness of a multifaceted , nonpharmaceutical intervention on incidence of falls and fallers .\
METHODS	Prospective , cluster-randomized , controlled 12-month trial .\
METHODS	Six community nursing homes in Germany .\
METHODS	Long-stay residents ( n = 981 ) aged 60 and older ; mean age 85 ; 79 % female .\
METHODS	Staff and resident education on fall prevention , advice on environmental adaptations , progressive balance and resistance training , and hip protectors .\
METHODS	Falls , fallers , and fractures .\
RESULTS	The incidence density rate of falls per 1,000 resident years ( RY ) was 2,558 for the control group ( CG ) and 1,399 for the intervention group ( IG ) ( relative risk ( RR ) = 0.55 , 95 % confidence interval ( CI ) = 0.41-0 .73 ) .\
RESULTS	Two hundred forty-seven ( 52.3 % ) fallers were detected in the CG and 188 ( 36.9 % ) in the IG ( RR = 0.75 , 95 % CI = 0.57-0 .98 ) .\
RESULTS	The incidence density rate of frequent fallers ( > 2/year ) was 115 ( 24.4 % ) for the CG and 66 ( 13.0 % ) for the IG ( RR = 0.56 , 95 % CI = 0.35-0 .89 ) .\
RESULTS	The incidence density rate of hip fractures per 1,000 RY was 39 for the CG and 43 for the IG ( RR = 1.11 , 95 % CI = 0.49-2 .51 ) .\
RESULTS	Other fractures were diagnosed with an incidence density rate of 52 per 1,000 RY for CG and 41 per 1,000 RY for IG ( RR = 0.78 , 95 % CI = 0.57-1 .07 ) .\
CONCLUSIONS	The incidence density rate of falls and fallers differed considerably between the control and intervention groups .\
CONCLUSIONS	The study was underpowered to demonstrate a significant difference of hip or nonhip fractures .\
CONCLUSIONS	Because of a low fracture rate in both groups , the investigation of fracture rates would have required a larger sample size to detect an effect of the intervention .\
\
###9386673\
OBJECTIVE	We compared the efficacy , safety , and immunogenicity of a rhesus rotavirus tetravalent vaccine ( RRV-TV ) , a rhesus rotavirus monovalent ( serotype 1 ) vaccine ( RRV-S1 ) , and placebo in healthy American Indian infants for two rotavirus seasons .\
METHODS	Infants aged 6 to 24 weeks were enrolled in a randomized , double-blind efficacy study .\
METHODS	Infants were orally administered RRV-TV ( 4 x 10 ( 5 ) plaque-forming units per dose ) , RRV-S1 ( 4 x 10 ( 5 ) plaque-forming units per dose ) , or placebo at 2 , 4 , and 6 months of age .\
METHODS	Stools collected during episodes of gastroenteritis were tested for detection of rotavirus antigen .\
METHODS	A total of 1185 infants received at least one dose of a study vaccine or placebo , and 1051 received all three doses according to the protocol .\
RESULTS	During the first year of surveillance , the estimates of vaccine efficacy ( with 95 % confidence interval ) for preventing rotaviral gastroenteritis were 50 % ( 26 , 67 ) for RRV-TV and 29 % ( -1 , 50 ) for RRV-S1 .\
RESULTS	In this population only 6 % of rotaviral gastroenteritis episodes among placebo recipients were associated with type G1 disease .\
RESULTS	For severe disease the estimates of vaccine efficacy were higher : 69 % ( 29 , 88 ) for RRV-TV and 48 % ( -4 , 75 ) for RRV-S1 .\
CONCLUSIONS	These data indicate that RRV-TV is moderately efficacious in preventing all episodes of gastroenteritis caused by rotavirus and is most efficacious against the severe disease characteristic of rotaviral illness .\
\
###17020801\
BACKGROUND	An easy-to-use vascular sealant with good safety and efficacy is needed to prevent anastomotic bleeding in vascular surgery .\
BACKGROUND	This study evaluated the safety and efficacy of cyanoacrylate surgical sealant in establishing hemostasis of expanded polytetrafluoroethylene to arterial vascular anastomoses in arteriovenous ( AV ) grafts and femoral bypass grafts .\
METHODS	This multicenter , randomized , controlled , open-label study was conducted in a hospital setting at 12 sites : 10 in the United States and 2 in Europe .\
METHODS	A total of 151 patients undergoing femoral bypass procedures or AV shunt procedures for hemodialysis access using expanded polytetrafluoroethylene grafts were randomized 2:1 to receive cyanoacrylate surgical sealant or the control ( oxidized cellulose ) between April 26 , 2004 , and January 18 , 2005 .\
METHODS	Randomization was stratified by clinical site and type of procedure .\
METHODS	After the anastomosis , cyanoacrylate surgical sealant or the control was applied to all anastomosis sites for patients undergoing femoral bypass procedures and to only the arterial anastomosis sites for patients undergoing AV shunt procedures .\
METHODS	The primary end point was the elapsed time from clamp release to hemostasis .\
METHODS	Secondary end points were the proportion of patients achieving hemostasis at t = 0 ( immediate ) , 1 , 5 , or 10 minutes after clamp release , use of additional adjunctive measures to achieve hemostasis , and occurrence of adverse events .\
RESULTS	Baseline demographics and clinical characteristics showed that the two treatment groups were similar at baseline .\
RESULTS	The mean time from clamp release to hemostasis was 119.3 seconds with cyanoacrylate surgical sealant vs 403.8 seconds with the control ( P < .001 ) .\
RESULTS	Immediate hemostasis was achieved in 54.5 % of patients receiving cyanoacrylate surgical sealant and in 10 % of those receiving the control .\
RESULTS	The proportion of patients requiring additional adjunctive measures was lower with cyanoacrylate surgical sealant , and the occurrence of adverse events was similar in both groups .\
CONCLUSIONS	This study demonstrates that cyanoacrylate surgical sealant is effective at reducing the time to hemostasis and achieving immediate hemostasis in AV shunt and femoral bypass procedures and that it is safe for internal use .\
CONCLUSIONS	Cyanoacrylate surgical sealant is an easy-to-use vascular sealant with good safety and efficacy that significantly decreases anastomotic bleeding in vascular surgery .\
\
###10921014\
OBJECTIVE	To study the effect of early postoperative intraperitoneal perfusion chemotherapy ( IPPC ) on the prevention of peritoneal recurrence and liver metastasis in patients with advanced colorectal cancer .\
METHODS	From 1990 through 1997 , 102 patients with advanced colorectal cancer were admitted .\
METHODS	The tumor invaded the intestinal serosa with elevated CEA in the peritoneal fluid .\
METHODS	Fifty-four of the 102 patients , beginning from the operation day , were given IPPC , once per day for 6 days , with warm ( 43-45 degrees C ) sterile double distilled water containing 1 g 5-Fu and 10 mg MMC .\
METHODS	The other 48 patients , as control , received 1 g 5-Fu and 8 mg MMC by i.v. infusion , once per day for 6 days .\
METHODS	In addition , oral tegafur was given to all patients with a total dose of 40 g.\
RESULTS	In patients treated with IPPC , peritoneal recurrence developed in 2 patients , liver metastasis in 2 patients whereas 12 cases had peritoneal recurrence and 6 had liver metastasis in patients treated by i.v. infusion .\
RESULTS	No complication developed in any of the treated patients .\
CONCLUSIONS	IPPC is effective in preventing tumor recurrence in the peritoneal cavity and metastasis to the liver in patients with advanced colorectal cancer .\
CONCLUSIONS	The treatment procedure is simple and safe .\
\
###24315572\
BACKGROUND	Former sleep studies among non-treatment seeking chronic cocaine users had captured polysomnographic changes for as long as three weeks of abstinence .\
METHODS	20 cocaine dependent participants , randomized to placebo in an ongoing clinical trial , received 12 days of inpatient substance abuse treatment followed by 6 weeks of outpatient cognitive behavioral therapy .\
METHODS	Polysomnographic recording was performed on consecutive nights during the 1st and 2nd inpatient and 3rd and 6th outpatient weeks .\
METHODS	Number of days abstinent was determined from thrice weekly urine toxicology and self-report .\
METHODS	Polysomnographic sleep was compared between study week 1 and 2 , using paired t-tests .\
METHODS	Trajectory of total sleep time ( TST ) was modeled both as a linear and a quadratic function of days abstinent .\
RESULTS	Despite reporting an improvement in overall sleep quality , polysomnographic sleep worsened from week 1 to 2 .\
RESULTS	Among all participants , TST and stage 2 sleep time decreased , while REM sleep latency increased .\
RESULTS	Among participants who began the study with a positive urine test , there was also a decrease in REM and a trend for decreased slow wave sleep .\
RESULTS	TST compared to number of days abstinent ( up to 54 days ) was best fit with a quadratic model ( p = 0.002 ) , suggesting the possibility of an improvement in total sleep time with extended abstinence .\
CONCLUSIONS	This is the first polysomnographic characterization of sleep in a large sample of cocaine users in treatment .\
CONCLUSIONS	Present findings confirm earlier results of poor and deteriorating sleep early in abstinence , and raise the possibility of improvement after an extended abstinence .\
\
###15330272\
OBJECTIVE	To compare the cholesterol-lowering efficacy and other metabolic effects of plant sterol and stanol esters , both of which are commonly used in the dietary management of hypercholesterolaemia .\
RESULTS	The cholesterol-lowering efficacy of equivalent intakes of sterol and stanol esters and of different intakes of stanol esters were compared at 1 and 2 months , both in normal subjects and treated patients with familial hypercholesterolaemia .\
RESULTS	Systemic effects were assessed by measuring serum levels of plant sterols and of lathosterol and 7alpha-hydroxy-cholestenone , indices of sterol absorption and of cholesterol and bile acid synthesis respectively .\
RESULTS	There were no significant differences during the study between 1.6 g daily of sterol and stanol esters in reducing total cholesterol ( by 3-7 % ) or low density lipoprotein cholesterol ( by 4-8 % ) , nor between 1.6 and 2.6 g daily of stanol .\
RESULTS	However , the cholesterol-lowering effect of plant sterol esters was attenuated between 1 and 2 months .\
RESULTS	This was accompanied by increased serum plant sterols and decreased levels of 7alpha-hydroxy-cholestenone , especially in statin-treated hypercholesterolaemic patients not taking bile acid sequestrants .\
CONCLUSIONS	These findings suggest that absorption of dietary plant sterols suppressed bile acid synthesis , thereby diminishing their cholesterol-lowering efficacy .\
CONCLUSIONS	In contrast , plant stanols reduced plant sterol absorption and maintained their cholesterol-lowering efficacy .\
\
###9738086\
METHODS	Although generalized convulsive status epilepticus is a life-threatening emergency , the best initial drug treatment is uncertain .\
METHODS	We conducted a five-year randomized , double-blind , multicenter trial of four intravenous regimens : diazepam ( 0.15 mg per kilogram of body weight ) followed by phenytoin ( 18 mg per kilogram ) , lorazepam ( 0.1 mg per kilogram ) , phenobarbital ( 15 mg per kilogram ) , and phenytoin ( 18 mg per kilogram ) .\
METHODS	Patients were classified as having either overt generalized status epilepticus ( defined as easily visible generalized convulsions ) or subtle status epilepticus ( indicated by coma and ictal discharges on the electroencephalogram , with or without subtle convulsive movements such as rhythmic muscle twitches or tonic eye deviation ) .\
METHODS	Treatment was considered successful when all motor and electroencephalographic seizure activity ceased within 20 minutes after the beginning of the drug infusion and there was no return of seizure activity during the next 40 minutes .\
METHODS	Analyses were performed with data on only the 518 patients with verified generalized convulsive status epilepticus as well as with data on all 570 patients who were enrolled .\
RESULTS	Three hundred eighty-four patients had a verified diagnosis of overt generalized convulsive status epilepticus .\
RESULTS	In this group , lorazepam was successful in 64.9 percent of those assigned to receive it , phenobarbital in 58.2 percent , diazepam plus phenytoin in 55.8 percent , and phenytoin in 43.6 percent ( P = 0.02 for the overall comparison among the four groups ) .\
RESULTS	Lorazepam was significantly superior to phenytoin in a pairwise comparison ( P = 0.002 ) .\
RESULTS	Among the 134 patients with a verified diagnosis of subtle generalized convulsive status epilepticus , no significant differences among the treatments were detected ( range of success rates , 7.7 to 24.2 percent ) .\
RESULTS	In an intention-to-treat analysis , the differences among treatment groups were not significant , either among the patients with overt status epilepticus ( P = 0.12 ) or among those with subtle status epilepticus ( P = 0.91 ) .\
RESULTS	There were no differences among the treatments with respect to recurrence during the 12-hour study period , the incidence of adverse reactions , or the outcome at 30 days .\
CONCLUSIONS	As initial intravenous treatment for overt generalized convulsive status epilepticus , lorazepam is more effective than phenytoin .\
CONCLUSIONS	Although lorazepam is no more efficacious than phenobarbital or diazepam plus phenytoin , it is easier to use .\
\
###7706955\
OBJECTIVE	To assess whether `` phasic '' exercises , including rapid eye-head-neck-arm movements , can benefit patients with chronic cervical injuries .\
METHODS	A randomized , controlled , double blind study involving 30 chronic patients , who were allocated to either group 1 or group 2 .\
METHODS	The study period was for 8 wk .\
METHODS	The study was conducted in a private practice .\
METHODS	Thirty chronic motor vehicle accident patients who continued to experience increased pain/soreness/stiffness of the cervical musculature with sports/activities requiring rapid head neck movements were selected for the study .\
METHODS	Group 1 patients ( n = 15 ) had standard exercises ( stretching/isometric/isokinetic ) and chiropractic therapy .\
METHODS	Group 2 patients ( n = 15 ) had `` phasic '' exercises and chiropractic therapy .\
METHODS	Patients in both groups exercised for a minimum of four times weekly , for 8 wk .\
METHODS	Pre and Post Pain and Disability Index was administered to both groups .\
RESULTS	Group 1 , which had standard exercises and chiropractic therapy , improved by 7.4 % ( p > .05 ) .\
RESULTS	Group 2 , which had `` phasic '' exercises and chiropractic therapy , improved by 48.3 % ( p > .001 ) .\
RESULTS	Confounders were identified , which explains the minimal improvement of group 1 and the remarkable results of group 2 .\
CONCLUSIONS	It would appear that any rehabilitation program for chronic neck-injured patients should involve exercises that address the following : eye-head-neck-arm coordinated movements , coordination of the entire vertebral column , / and return the `` phasic '' component of the musculature to functional levels .\
CONCLUSIONS	Additional studies will address the effect of these exercises on the strength , range of motion and pain improvement of the cervical spine in normal , acute and chronic patients .\
\
###16182024\
OBJECTIVE	The objective of this study was to investigate the relationship between the number of sites of spinal dysfunction and a range of measures of cognitive processing .\
METHODS	This double-blind , randomized , observational pilot study was performed at a chiropractic college clinical training facility .\
METHODS	Thirty volunteers with clinical evidence of cervical spinal joint dysfunction participated .\
METHODS	Subjects were classified into 2 groups depending on whether they exhibited signs of cervical spinal joint dysfunction at one or more sites .\
METHODS	A range of computer-based tasks was used to determine simple reaction time ( RT ) , choice RT , probe RT , and inhibition of a preplanned response .\
RESULTS	Multiple sites of cervical spinal joint dysfunction were related to impaired cortical processing as revealed by significantly higher loads on central capacity , significantly less accurate response selection , and a trend toward more variable performance of an anticipated response .\
RESULTS	Multiple sites of cervical spinal joint dysfunction do not appear to be related to the speed of response selection or the ability to inhibit a preplanned response .\
CONCLUSIONS	This pilot study provides a context for the improvements in cortical processing observed after cervical spine adjustment .\
CONCLUSIONS	It shows that probe RT may be a useful tool in further studies examining the effects of cervical spine manipulation of joint dysfunction and the associated effect on cognitive function .\
\
###10501335\
BACKGROUND	Contrast echocardiography may be used to assess myocardial perfusion .\
BACKGROUND	However , gray scale assessment of myocardial contrast echocardiography ( MCE ) is difficult because of variations in regional backscatter intensity , difficulties in distinguishing varying shades of gray , and artifacts or attenuation .\
BACKGROUND	We sought to determine whether the assessment of rest myocardial perfusion by MCE could be improved with subtraction and color coding .\
RESULTS	MCE was performed in 31 patients with previous myocardial infarction with a 2nd generation agent ( NC100100 , Nycomed AS ) , using harmonic triggered or continuous imaging and gain settings were kept constant throughout the study .\
RESULTS	Digitized images were post processed by subtraction of baseline from contrast data and colorized to reflect the intensity of myocardial contrast .\
RESULTS	Gray scale MCE alone , MCE images combined with baseline and subtracted colorized images were scored independently using a 16 segment model .\
RESULTS	The presence and severity of myocardial contrast abnormalities were compared with perfusion defined by rest MIBI-SPECT .\
RESULTS	Segments that were not visualized by continuous ( 17 % ) or triggered imaging ( 14 % ) after color processing were excluded from further analysis .\
RESULTS	The specificity of gray scale MCE alone ( 56 % ) or MCE combined with baseline 2D ( 47 % ) was significantly enhanced by subtraction and color coding ( 76 % , p < 0.001 ) of triggered images .\
RESULTS	The accuracy of the gray scale approaches ( respectively 52 % and 47 % ) was increased to 70 % ( p < 0.001 ) .\
RESULTS	Similarly , for continuous images , the specificity of gray scale MCE with and without baseline comparison was 23 % and 42 % respectively , compared with 60 % after post processing ( p < 0.001 ) .\
RESULTS	The accuracy of colorized images ( 59 % ) was also significantly greater than gray scale MCE ( 43 % and 29 % , p < 0.001 ) .\
RESULTS	The sensitivity of MCE for both acquisitions was not altered by subtraction .\
CONCLUSIONS	Post-processing with subtraction and color coding significantly improves the accuracy and specificity of MCE for detection of perfusion defects .\
\
###15691552\
OBJECTIVE	To evaluate the role of topical mitomycin C in corneal wound healing ( CWH ) after photorefractive keratectomy ( PRK ) in highly myopic eyes .\
METHODS	Prospective , double-masked , randomized clinical trial .\
METHODS	Seventy-two eyes of 36 patients affected by high ( > 7 diopters ) myopia .\
METHODS	In each patient , one eye was randomly assigned to PRK with intraoperative topical 0.02 % mitomycin C application , and the fellow eye was treated with a placebo .\
METHODS	Postoperatively , mitomycin C-treated eyes received artificial tears ( 3 times daily , tapered in 3 months ) , whereas the fellow eye was treated with fluorometholone sodium 2 % and artificial tears ( 3 times daily , tapered in 3 months ) .\
METHODS	Uncorrected visual acuity ( UCVA ) and best-corrected visual acuity ( BCVA ) , contrast sensitivity , manifest refraction , and biomicroscopy .\
METHODS	Contrast sensitivity was determined using the Pelli-Robson chart .\
METHODS	Corneal confocal microscopy documented CWH .\
RESULTS	Mean follow-up was 18 months ( range , 12-36 ) .\
RESULTS	No side effects or toxic effects were documented .\
RESULTS	At 12-month follow-up examination , UCVAs ( logarithm of the minimum angle of resolution ) were 0.4 + / -0.48 and 0.5 + / -0.53 ( P = .03 ) in mitomycin C-treated eyes and corticosteroid-treated eyes , respectively .\
RESULTS	At 1 year , corneal haze developed in 20 % of corticosteroid-treated eyes , versus 0 % of mitomycin C-treated eyes .\
RESULTS	At 12 , 24 , and 36 months , corneal confocal microscopy showed activated keratocytes and extracellular matrix significantly more evident in untreated eyes ( Ps = 0.004 , 0.024 , and 0.046 , respectively ) .\
CONCLUSIONS	Topical intraoperative application of 0.02 % mitomycin C can reduce haze formation in highly myopic eyes undergoing PRK .\
\
###21367351\
BACKGROUND	Most patients with anxiety disorders receive their care from primary care practitioners ( PCPs ) .\
BACKGROUND	The purpose of this study was to evaluate quality of and patient satisfaction with primary health care for anxiety disorders .\
METHODS	A survey was performed among 1,004 outpatients with anxiety disorders ( diagnosed according to DSM-IV ) referred by their PCPs from 17 primary care clinical settings ( 3 of which were university-affiliated ) in 4 regions of the United States for participation in the Coordinated Anxiety Learning and Management ( CALM ) study , a therapeutic trial .\
METHODS	Participating research institutions were the University of Washington at Seattle , the University of California at San Diego and Los Angeles , and the University of Arkansas for Medical Sciences at Little Rock .\
METHODS	Enrollment took place between June 2006 and April 2008 .\
METHODS	Patients were contacted by telephone after enrollment to provide information about previous care received ( during the 6 months prior to referral ) and satisfaction with that care .\
METHODS	Quality-of-care indicators were self-reported type , dose , and duration of antianxiety medication treatment and self-reported psychotherapy with cognitive-behavioral therapy ( CBT ) elements .\
RESULTS	A total of 576 patients ( 57.4 % ) had received an appropriate antianxiety medication in the previous 6 months , but only 289 patients ( 29.4 % of 983 who answered this question ) had received the medication at adequate dose for at least 2 months .\
RESULTS	A total of 465 patients ( 46.3 % ) had received some counseling with at least 1 element of CBT , but only 213 patients ( 21.2 % ) had received counseling with a strong ( 3 + elements ) CBT focus .\
RESULTS	Overall , 416 patients ( 41.4 % ) had received quality pharmacotherapy or psychotherapy , and 81 patients ( 8.1 % ) had received both .\
RESULTS	Only 432 patients ( 44.8 % of 964 who answered this question ) were at least somewhat satisfied with their mental health care .\
RESULTS	Receipt of quality psychotherapy was the sole positive predictor ( adjusted odds ratio = 2.71 ; 95 % CI , 1.94-3 .80 ; P < .0005 ) of satisfaction with mental health care for anxiety .\
RESULTS	Moreover , there was a dose-response relationship between the number of CBT elements consistently delivered and satisfaction with care ( test for trend , z = 4.06 , P < .0005 ) .\
CONCLUSIONS	Despite recognition of these patients ' anxiety disorders and referral by their PCPs to an anxiety treatment study , fewer than half of the patients had in the prior 6 months received quality pharmacologic and/or psychosocial mental health care .\
CONCLUSIONS	Receipt of CBT-oriented , quality psychosocial ( but not pharmacologic ) care showed a strong dose-response relationship with satisfaction with mental health care .\
\
###12579101\
OBJECTIVE	The incidence of heparin-induced thrombocytopenia is increasing , and the thrombin inhibitor danaparoid could be a useful alternative .\
OBJECTIVE	The objective of the present study was to compare danaparoid and heparin in patients undergoing off-pump coronary artery bypass grafting .\
METHODS	In a prospective , randomized , double-blind clinical trial comparing heparin ( bolus of 1 mg/kg ) with danaparoid ( bolus of 40 U/kg ) , 71 patients underwent off-pump coronary artery bypass grafting with one of the study drugs .\
METHODS	The amount of blood lost , the number of homologous blood products transfused , the troponin T levels , and the amount of anti-Xa activity were monitored .\
RESULTS	Thirty-four patients underwent 2.6 + / - 0.7 bypasses with danaparoid , and 37 patients underwent 2.5 + / - 0.9 grafts with heparin ( P = .8 ) .\
RESULTS	Postoperative blood losses averaged 1394 + / - 1033 mL in patients receiving danaparoid and 1130 + / - 868 mL in patients receiving heparin ( P = .2 ) .\
RESULTS	The number of homologous blood products transfused averaged 3.6 + / - 7 units in patients receiving danaparoid and 1.9 + / - 4.4 units in patients receiving heparin ( P = .2 ) .\
RESULTS	The number of patients requiring homologous blood transfusion was higher in patients receiving danaparoid ( 18/34 [ 53 % ] ) than in patients receiving heparin ( 10/37 [ 27 % ] , P = .03 ) .\
RESULTS	Serum anti-Xa activity averaged 1.6 + / - 0.6 U/mL in patients receiving danaparoid and 1.9 + / - 0.8 U/mL in patients receiving heparin 30 minutes after injection of the drugs ( P = .1 ) and 0.3 + / - 0.1 and 0.04 + / - 0.08 U/mL , respectively , 12 hours after coronary artery bypass grafting ( P = .001 ) .\
RESULTS	Troponin serum levels were similar 48 hours after coronary artery bypass grafting ( 0.5 + / - 0.6 and 0.4 + / - 0.6 microg/L , respectively ) .\
CONCLUSIONS	Although off-pump coronary artery bypass grafting with danaparoid versus heparin increases the number of patients exposed to homologous blood transfusion ( relative risk , 2 ; 95 % confidence limits , 1-4 ) , off-pump coronary artery bypass grafting with danaparoid is a valuable alternative to heparin in patients with thrombocytopenia requiring surgical intervention .\
\
###22707262\
METHODS	Dietary lipids are considered to be primary potentiators of carotenoid absorption , yet the amount and source required to optimize bioavailability has not been systematically evaluated .\
METHODS	The objective of this study was to examine the impact of both amount and source of triacylglycerols on postprandial absorption of carotenoids from vegetable salads .\
RESULTS	Healthy subjects ( n = 29 ) were randomized using a Latin square design ( 3 3 ) and consumed three identical salads with 3 , 8 , or 20 g of canola oil , soybean oil , or butter .\
RESULTS	Blood was collected from 0-10 h and triacylglycerol-rich fractions ( TRLs ) were isolated by ultracentrifugation .\
RESULTS	Carotenoid contents of TRL fractions were analyzed by HPLC-DAD .\
RESULTS	Considering all lipid sources , 20 g of lipid promoted higher absorption compared to 3 and 8 g for all carotenoid species ( p < 0.05 ) , except for - carotene ( p = 0.07 ) .\
RESULTS	The source of lipid had less impact on the absorption of carotenoids than amount of lipid .\
RESULTS	Pooling results from all lipid amounts , monounsaturated fatty acid rich canola oil trended toward enhancing absorption of lutein and - carotene compared to saturated fatty acid rich butter ( p = 0.06 and p = 0.08 , respectively ) .\
CONCLUSIONS	While both amount and source of co-consumed lipid affect carotenoid bioavailability from vegetables , amount appears to exert a stronger effect .\
\
###8202005\
OBJECTIVE	To assess the effectiveness of single-dose prednisolone in reducing the length of illness and hospital stay in children admitted with moderately severe asthma .\
METHODS	A randomised , double-blind , controlled trial of a single dose of prednisolone in 64 children presenting with an acute attack of asthma with arterial oxygen saturation less than 93 % .\
RESULTS	No significant differences in the rate of recovery of oxygen saturation , lung function measurements or duration of hospital stay were found .\
CONCLUSIONS	This study failed to confirm the benefit of a single dose of prednisolone in the management of children with acute severe asthma .\
\
###15896432\
OBJECTIVE	Rheumatoid arthritis ( RA ) is complicated by cytokine-driven alterations in protein and energy metabolism and consequent muscle wasting ( cachexia ) .\
OBJECTIVE	The aim of this randomised controlled trial was to investigate the efficacy of a mixture of beta-hydroxy-beta-methylbutyrate , glutamine and arginine ( HMB/GLN/ARG ) as nutritional treatment for rheumatoid cachexia .\
METHODS	Forty RA patients supplemented their diet with either HMB/GLN/ARG or a nitrogen ( 7.19 g/day ) and calorie ( 180 kcal/day ) balanced mixture of alanine , glutamic acid , glycine , and serine ( placebo ) for 12 weeks .\
METHODS	Body composition and other outcomes were assessed at baseline and follow-up , and analysed by mixed ANOVA .\
RESULTS	Dietary supplementation with HMB/GLN/ARG was not superior to placebo in the treatment of rheumatoid cachexia ( groupxtime interactions P > 0.05 for all outcomes ) .\
RESULTS	Both amino acid mixtures significantly increased ( main effect of time ) fat-free mass ( 727 + / -1186 g , P < 0.01 ) , total body protein ( 719 + / -1703 g , P = 0.02 ) , arms ( 112 + / -183 g , P < 0.01 ) and legs ( 283 + / -534 g , P < 0.01 ) lean mass , and some measures of physical function .\
RESULTS	No significant adverse event occurred during the study , but patients in the HMB/GLN/ARG group reported fewer gastrointestinal complaints compared to placebo .\
CONCLUSIONS	Dietary supplementation with HMB/GLN/ARG is better tolerated but not more effective in reversing cachexia in RA patients compared to the mixture of other non-essential amino acids used as placebo .\
CONCLUSIONS	Further controlled studies are necessary to confirm the beneficial anabolic and functional effects of increased nitrogen intake in this population .\
\
###25394855\
BACKGROUND	It is not uncommon for patients with ischemic stroke to have peripheral arterial disease ( PAD ) .\
BACKGROUND	Patients with polyvascular diseases carry greater burden of atherosclerosis and higher risks of developing vascular events and death .\
BACKGROUND	More effective regimens , such as dual antiplatelet agents , may be more effective for controlling progression of atherosclerosis in secondary prevention .\
OBJECTIVE	This study aims to evaluate whether cilostazol plus aspirin is more efficacious than aspirin alone for preventing progression of atherosclerosis in patients with ischemic stroke or transient ischemic attack ( TIA ) who also have peripheral arterial disease .\
METHODS	The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients with Peripheral Arterial Disease ( SPAD ) study is a randomized double-blinded placebo-controlled trial .\
METHODS	Patients with previous ischemic stroke or TIA who had been taking aspirin ( 100mg per day ) , aged 50 years or older , with PAD in the lower limbs based on ankle-brachial index ( ABI ) < 10 will be randomized into the treatment group with cilostazol ( 200mg/day ) or the placebo group on 1:1 basis .\
RESULTS	Patients will be evaluated at 1 , 3 , 6 , 9 and 12 months after randomization .\
RESULTS	The primary endpoint is difference in change in ABI between groups .\
RESULTS	The secondary and tertiary endpoints are the difference between groups in change in carotid intima-media thickness ( IMT ) and incidence rate of major cardiovascular events , including recurrent stroke , myocardial infarction , unstable angina , other vascular events , and death ; and the safety measures , including major bleeding events , hemorrhagic stroke and death of any cause .\
CONCLUSIONS	The SPAD trial is the first study to evaluate the safety and efficacy of dual antiplatelet agents , aspirin plus cilostazol , in comparison with aspirin alone in patients with both ischemic stroke or TIA and PAD .\
CONCLUSIONS	Results from this trial will provide important information on the merit of adding cilostazol to aspirin for slowing down progression of atherosclerosis in patients with ischemic stroke and PAD .\
\
###10470637\
OBJECTIVE	To investigate the effects of angle and length of the Trachlight lightwand and the effect of obesity on transillumination of the neck and difficulty of intubation .\
METHODS	Prospective , randomized study .\
METHODS	Operating room of a university hospital .\
METHODS	270 patients , aged 30 to 70 years , requiring anesthesia .\
METHODS	Three different studies were performed .\
METHODS	1 ) One hundred twenty adults for general anesthesia to test the effect of the angle , 2 ) 120 patients for the length of the extrusion , and 3 ) 30 patients with body weight > or = 120 % of the standard ( Broca 's formula ) versus 30 with body weight < 120 % of the standard to test the effect of the obesity .\
METHODS	1 ) The lightwand was bent at 20 degrees , 40 degrees , 60 degrees , or 80 degrees with 0 cm extruded from the endotracheal tube ; 2 ) the lightwand was exposed from the endotracheal tube with -0.5 , 0 , 1 , 2 , 3 , or 4 cm with 40 degrees angle ; and 3 ) the effect of obesity was tested with 40 degrees angle and 0-cm extrusion .\
METHODS	Endotracheal intubation was performed using the lightwand .\
METHODS	Transillumination of the light at neck and the difficulty of intubation were assessed .\
RESULTS	1 ) A 20 degrees angle decreased the transillumination and an 80 degrees angle increased the number of difficult intubation .\
RESULTS	2 ) Transillumination decreased with -0.5 cm and 0 cm extrusion .\
RESULTS	Difficult intubation increased with the extrusion > or = 3 cm .\
RESULTS	3 ) Transillumination decreased and difficult intubation increased in the patients with body weight > or = 120 % of the standard .\
CONCLUSIONS	To increase the success rate of tracheal intubation using the lightwand , the lightwand should be bent in 40 degrees to 60 degrees , with the extrusion of 1 to 2 cm from the tracheal tube .\
CONCLUSIONS	For obese patients with body weight > or = 120 % of the standard , the lightwand was not useful .\
\
###21526411\
OBJECTIVE	To evaluate whether the Pharmacy First Minor Ailments scheme achieved its objectives in terms of improving access to medicines and reducing doctor workload for minor ailments by enhancing the role of community pharmacists in the management of minor ailments .\
METHODS	Nottingham , the United Kingdom .\
METHODS	A mixed-methods study was conducted , including semi-structured interviews with key stakeholders , a patient survey , and an analysis of the Nottingham City Primary Care Trust data .\
METHODS	Stakeholders ' acceptability of the scheme and scheme users ' satisfaction with the scheme .\
RESULTS	Most health care professionals were positive about the implementation of the scheme , although they reported some problems , such as the restricted formulary .\
RESULTS	The majority of stakeholders perceived benefits of the scheme for both patients and health care professionals .\
RESULTS	The level of patient satisfaction with the scheme was high , particularly in terms of ease of access and convenience .\
RESULTS	The current structure of the scheme appears to be an acceptable way to run the scheme .\
RESULTS	Since its commencement the scheme has enabled the transfer of a substantial number of minor ailments consultations from general practices to community pharmacies .\
CONCLUSIONS	It appears that the Nottingham City Primary Care Trust is successful using community pharmacies to improve access to medicines and provide a greater choice in primary care for patients with minor ailments .\
CONCLUSIONS	Thus , the Primary Care Trust should continue the scheme , although there are some important issues ( e.g. the restricted formulary , the lack of privacy in some pharmacies ) that need to be addressed to improve and develop the service further .\
CONCLUSIONS	The Nottingham City Primary Care Trust should build on this success to further utilise the pharmacy in their primary care service development .\
\
###21392837\
BACKGROUND	Chronic heart failure ( CHF ) accounts for significant morbidity , mortality and health expenditure .\
BACKGROUND	Furthermore , patients with CHF are often on numerous pharmacological agents for their comorbidities .\
BACKGROUND	The objective of this study was to determine whether a pharmacist directed home medication review intervention had positive effects on CHF patient outcomes .\
METHODS	A total of 120 patients hospitalised for CHF were randomised to receive a pharmacist directed post-discharge home medication review ( n = 64 , 53.3 % ) or standard care ( n = 56 , 46.7 % ) .\
METHODS	Participants were followed for 6 months .\
METHODS	Primary outcomes were death , CHF hospitalisation and length of hospital stay .\
RESULTS	There were no between group differences in mortality ( hazard ratio = 1.41 , 0.50 to 3.97 ; P = 0.514 ) or CHF hospitalizations ( incidence rate ratio [ IRR ] = 1.74 95 % CI : 0.85-3 .60 P = 0.131 ) over the 6 month follow-up period .\
RESULTS	Days of hospital stay for CHF exacerbations in the 6 month follow-up were significantly greater in the intervention group ( IRR = 2.34 95 % CI : 1.80-3 .05 P = 0.000 ) .\
CONCLUSIONS	Post-discharge pharmacy directed home medication review appeared to have no effect on mortality and health care utilisation above that achieved with standard care .\
CONCLUSIONS	The post-acute management of CHF must be a collaborative multi-disciplinary effort by the health care team as it is the additive effect of interventions that are most effective .\
\
###21338971\
BACKGROUND	Infantile hypertrophic pyloric stenosis ( IHPS ) is the most common cause of nonbilious vomiting in infancy , with an incidence of 1 to 3 per 1000 live births .\
BACKGROUND	Different approaches have been advocated for pyloromyotomy aiming to achieve better cosmetic results with least possible complications .\
BACKGROUND	Although many studies have shown that the umbilical pyloromyotomy is as safe as the traditional right upper quadrant approach with superior cosmetic results , still few studies reports high complication rates .\
BACKGROUND	The aim of this study was to assess intracavitary pyloromyotomy ( ICP ) in comparison with extracavitary pyloromyotomy ( ECP ) regarding the operative time , operative and postoperative complications , time to return to full oral feeding , and duration of hospital stay , as well as the final cosmetic results through supra umbilical skin incision .\
METHODS	Forty patients with IHPS were admitted to Assiut University Children Hospital from January 2008 to June 2010 and operated through supra umbilical incision .\
METHODS	They were randomly divided according to the surgical technique into 2 groups : ECP group ( 20 patients ) and ICP group ( 20 patients ) .\
METHODS	The evaluating parameters were : pyloric muscle thickness , operative time , operative and postoperative complications , time to return to full oral feeding , duration of hospital stay , and final cosmetic results .\
RESULTS	There was no statistical significant difference between both groups regarding the patient 's age , weight , pyloric muscle thickness , and duration of hospital stay .\
RESULTS	No mortality was encountered among all patients .\
RESULTS	There was a statistical significant difference between both groups regarding the mean operative time and time to return to full oral feeding .\
RESULTS	During the follow-up period ( ranged from 6 weeks to 8 weeks ) all patients were gaining weight satisfactorily and the scar was barely visible .\
CONCLUSIONS	ICP for pyloromyotomy is safe and can be done in large pyloric masses without wound extension .\
CONCLUSIONS	It gives best cosmetic results with minimal complications .\
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###15855574\
OBJECTIVE	To investigate the pharmacodynamic profile and duration of action for five subcutaneous doses of insulin detemir ( 0.1 , 0.2 , 0.4 , 0.8 , and 1.6 units/kg ; 1 unit = 24 nmol ) and one subcutaneous dose of NPH insulin ( 0.3 IU/kg ; 1 IU = 6 nmol ) .\
METHODS	This single-center , randomized , double-blind , six-period , crossover study was carried out as a 24-h isoglycemic clamp ( 7.2 mmol/l ) in 12 type 1 diabetic patients .\
RESULTS	Duration of action for insulin detemir was dose dependent and varied from 5.7 , to 12.1 , to 19.9 , to 22.7 , to 23.2 h for 0.1 , 0.2 , 0.4 , 0.8 , and 1.6 units/kg , respectively .\
RESULTS	Interpolation of the dose-response relationships for AUC ( GIR ) ( area under the glucose infusion rate curve ) revealed that a detemir dose of 0.29 units/kg would provide the same effect as 0.3 IU/kg NPH but has a longer duration of action ( 16.9 vs. 12.7 h , respectively ) .\
RESULTS	Lower between-subject variability was observed for insulin detemir on duration of action ( 0.4 units/kg insulin detemir vs. 0.3 IU/kg NPH , P < 0.05 ) and GIR ( max ) ( maximal glucose infusion rate ) ( 0.2 and 0.4 units/kg insulin detemir vs. 0.3 IU/kg NPH , both P < 0.05 ) .\
RESULTS	Assessment of endogenous glucose production ( EGP ) and peripheral glucose uptake ( PGU ) resulted in an AOC ( EGP ) ( area over the EGP curve ) of 636 mg/kg ( 95 % CI 279-879 ) vs. 584 ( 323-846 ) and an AUC ( PGU ) ( area under the PGU curve ) of 173 ( 47-316 ) vs. 328 ( 39-617 ) for 0.29 units/kg detemir vs. 0.3 IU/kg NPH , respectively .\
CONCLUSIONS	This study shows that insulin detemir provides a flat and protracted pharmacodynamic profile .\
\
###25428337\
OBJECTIVE	To determine the impact of adjunctive Buchang Naoxintong Capsule ( , NXT ) on dual antiplatelet therapy in patients with cytochrome P450 2C19 * 2 ( CYP2C19 * 2 ) polymorphism undergoing percutaneous coronary intervention ( PCI ) .\
METHODS	Ninety patients with CYP2C19 * 2 polymorphism were enrolled , and their genotypes were confirmed by polymerase chain reaction ( PCR ) .\
METHODS	The patients were randomly assigned to receive either adjunctive NXT ( triple group , 45 cases ) or dual antiplatelet therapy ( dual group , 45 cases ) using a computer-generated randomization sequence and sealed envelopes .\
METHODS	Platelet function was assessed at baseline and 7 days after treatment with conventional aggregometry .\
METHODS	Subsequent major adverse cardiovascular events ( MACE , including sudden cardiac arrest and acute coronary syndrome ) were recorded during a 12-month follow-up .\
RESULTS	Baseline platelet function measurements were similar in both groups .\
RESULTS	After 7 days , percent inhibitions of maximum platelet aggregation and late platelet aggregation were significantly greater in the triple versus dual group ( 42.3 % 16.0 % vs. 20.8 % 15.2 % , P < 0.01 , and 54.7 % 18.3 % vs. 21.5 % 29.2 % , P < 0.01 , respectively ) .\
RESULTS	During the 12-month follow-up , the rate of subsequent MACE ( 6/45 ) was significantly lower in the triple group compared with the dual group ( 14/45 ; P < 0.05 ) .\
CONCLUSIONS	Adjunctive NXT to maintenance dose clopidogrel ( 75 g ) could enhance the antiplatelet effect and decrease subsequent MACE in patients with the CYP2C19 * 2 polymorphism undergoing PCI .\
\
###17573796\
OBJECTIVE	The safety and efficacy of NaP tablets have not been compared with 2L PEG lavage solution .\
OBJECTIVE	A multicenter , investigator-blinded study was conducted to compare the colon-cleansing efficacy of a new NaP tablet formulation with that of 2L PEG solution plus bisacodyl tablets in adults undergoing colonoscopy .\
METHODS	A total of 481 patients were randomized to receive either 32 tablets ( 48 g ) of NaP or 2L PEG solution plus 4 ( 20 mg ) bisacodyl tablets .\
METHODS	Quality of colon cleansing was assessed using a 4-point scale ( 1 = excellent , 2 = good , 3 = fair , and 4 = inadequate ) , and the primary efficacy end point was mean overall colon-cleansing score .\
METHODS	Safety assessments included recording of adverse events and changes in biochemical tests and vital signs .\
RESULTS	A total of 411 patients were included in the efficacy analysis .\
RESULTS	The mean overall and ascending colon-cleansing scores for NaP tablets were significantly better than PEG plus bisacodyl ( overall 1.5 vs 1.8 , ascending 1.4 vs 1.8 , P < 0.0001 for both ) .\
RESULTS	Patients treated with NaP tablets experienced significantly fewer adverse events ( 66 % vs 82 % , P = 0.0003 ) and gastrointestinal symptoms ( 64 % vs 79 % , P = 0.0001 ) compared with patients receiving PEG plus bisacodyl .\
RESULTS	Patients receiving NaP tablets were significantly less likely to experience abdominal distention , abdominal pain , and vomiting than patients receiving PEG plus bisacodyl ( P < 0.0012 ) .\
RESULTS	Transient fluctuations in laboratory parameters were observed in both treatment groups ; however , the fluctuations were more common and of greater magnitude in the NaP group particularly in phosphorous , sodium , and potassium .\
CONCLUSIONS	The colon-cleansing efficacy of the new 32-tablet NaP dosing regimen in this study was found to be significantly better than the 2L PEG solution plus bisacodyl tablets regimen .\
CONCLUSIONS	The 32-tablet NaP dosing regimen was associated with fewer adverse events .\
CONCLUSIONS	As expected electrolyte shifts were more common and of greater magnitude in the NaP group compared with the PEG plus bisacodyl group ; however , both treatment groups demonstrated significant changes in electrolytes and creatinine .\
\
###24435244\
BACKGROUND	This study aims at investigating the effect of a single pre-operative oral administration of morphine sulphate ( Oramorph ) on pain after laparoscopic cholecystectomy ( LC ) .\
METHODS	Forty-one ASA I-III patients , aged 18-65 years , undergoing LC were randomly , double-blindly allocated to treatment ( N. = 20 , 30mg Oramorph , group M ) or placebo ( N. = 21 , group P ) .\
METHODS	General anesthesia was maintained with propofol and remifentanil .\
METHODS	All patients received ketamine 0.2 mg/kg iv at induction , intraoperative ketorolac 30mg iv and tramadol postoperatively ( iv PCA : bolus 50 mg , lock-out 30 min , max 100 mg/4 hours ) .\
METHODS	Numerical rating scale for pain ( NRS ) , White 's fast track and PADSS scores , tramadol consumption and adverse events were recorded for the first 24h .\
METHODS	All patients underwent State Trait Anxiety Inventory ( STAI ) and Mini Mental State Examination ( MMSE ) .\
RESULTS	Anthropometric characteristics , MMSE , STAI , ASA status , NRS rest , White 's and PADDS scores , PONV incidence were similar .\
RESULTS	Group M showed significantly lower NRS on movement during the first 3 hours after awakening .\
RESULTS	Cumulative tramadol consumption was lower in group M than in group P ( 185142 mg versus 263199 mg , P = 0.199 ) .\
CONCLUSIONS	Within a multimodal approach , a single preoperative oral administration of 30 mg of morphine sulphate in patients undergoing LC did not improve pain at rest , but improved NRS on movement during the first 3 hours after awakening .\
CONCLUSIONS	Group P required a higher mean dose of tramadol compared to Group M , although not significantly .\
CONCLUSIONS	The safety profile of Oramorph allowed fast extubation and awakening times as well as prompt home discharge within 6 hours from surgery .\
\
###11816230\
OBJECTIVE	To prove the benefit of an educational intervention for controlling LDL cholesterol levels in LDL cholesterol .\
METHODS	A quasi-experimental study was conducted ; diabetic patients were randomly allocated to an experimental and a control group .\
METHODS	The experimental group consisted of 25 patients and the control group of 24 patients .\
METHODS	The educational intervention was organized through a reflection-action process .\
METHODS	LDL cholesterol levels were measured at baseline and monthly during the nine months of the study .\
METHODS	The groups were controlled for age and sex .\
METHODS	Statistical analysis included Wilcoxon 's test for ordinal variables .\
RESULTS	The intervention group had a mean value of LDL cholesterol of 148.4 + / - 21.3 , compared to 185 + / - 24.1 in the control group ( p < or = 0.05 ) .\
CONCLUSIONS	The participative educational intervention contributed to improving the levels of LDL cholesterol , by promoting a lifestyle change in type-2 diabetic patients .\
\
###25044819\
BACKGROUND	Palliative care incorporates comprehensive support of family caregivers because many of them experience burden and distress .\
BACKGROUND	However , evidence-based support initiatives are few .\
OBJECTIVE	We evaluated a one-to-one psychoeducational intervention aimed at mitigating the distress of caregivers of patients with advanced cancer receiving home-based palliative care .\
OBJECTIVE	We hypothesised that caregivers would report decreased distress as assessed by the General Health Questionnaire ( GHQ ) .\
METHODS	A randomised controlled trial comparing two versions of the delivery of the intervention ( one face-to-face home visit plus telephone calls versus two visits ) plus standard care to a control group ( standard care only ) across four sites in Australia .\
RESULTS	Recruitment to the one visit condition was 57 , the two visit condition 93 , and the control 148 .\
RESULTS	We previously reported non-significant changes in distress between times 1 ( baseline ) and 2 ( 1-week post-intervention ) but significant gains in competence and preparedness .\
RESULTS	We report here changes in distress between times 1 and 3 ( 8-week post-death ) .\
RESULTS	There was significantly less worsening in distress between times 1 and 3 in the one visit intervention group than in the control group ; however , no significant difference was found between the two visit intervention and the control group .\
CONCLUSIONS	These results are consistent with the aim of the intervention , and they support existing evidence demonstrating that relatively short psychoeducational interventions can help family caregivers who are supporting a dying relative .\
CONCLUSIONS	The sustained benefit during the bereavement period may also have positive resource implications , which should be the subject of future inquiry .\
\
###21161116\
OBJECTIVE	To determine the effect of isometric handgrip training on blood pressure ( BP ) in middle-aged women ( 47.88 1.8 years ) .\
METHODS	Isometric handgrip training was performed over five consecutive days .\
METHODS	In each session , the treatment group ( n = 9 ) performed four isometric contractions of 45 seconds each at 30 % of their maximal grip strength .\
METHODS	The control group ( n = 9 ) sat for 15 minutes without exercising , for five consecutive days .\
METHODS	Resting systolic ( SBP ) and diastolic blood pressure ( DBP ) were measured pre - and post-intervention .\
METHODS	Data were analysed using a two-factor ANOVA ( p 0.05 ) .\
RESULTS	Blood pressure readings were reduced in both groups ( SBP : p = 0.036 ; DBP : p = 0.0079 ) , however there was no interaction effect for SBP or DBP .\
CONCLUSIONS	The findings suggest that 15 minutes of sitting per day for five consecutive days is just as effective as isometric handgrip training for reducing BP levels .\
CONCLUSIONS	Future research is required to investigate the optimal isometric handgrip training stimulus required to reduce resting BP levels .\
\
###18052699\
BACKGROUND	This study compared clinical and radiographic findings for the treatment of Class II furcation defects in human mandibular molars using anorganic bovine-derived hydroxyapatite matrix ( ABM ) / cell-binding peptide ( P-15 ) or open flap debridement ( OFD ) .\
METHODS	Twelve subjects showing two comparable Class II furcation defects in their mandibular molars were enrolled .\
METHODS	The defects in each subject were assigned randomly to the test ( ABM/P -15 ) or the control ( OFD ) group .\
METHODS	Clinical measurements and standardized radiographs were taken at baseline and 6 to 7 months after surgery .\
RESULTS	There were no statistically significant differences between the test and control groups for any clinical or radiographic parameter ( P > 0.05 ) .\
RESULTS	On comparing the baseline and final measurements , the gain in horizontal clinical attachment level and reduction in gingival recession were significant only in the test group ( P < or = 0.02 ) , whereas the gain in the vertical clinical attachment level was significant in both groups ( P < or = 0.04 ) .\
RESULTS	In the test group , four of 12 sites showed complete closure , and five showed partial closure ; in the control group , three defects showed complete closure , and four showed partial closure ( P = 0.42 ) .\
RESULTS	Subtraction radiography revealed similar gains in bone height and increases in mean bone density with both treatments ( P > 0.05 ) .\
CONCLUSIONS	ABM/P -15 yielded favorable results in the treatment of Class II furcation defects over a 6-month evaluation period ; however , there was no difference compared to OFD .\
CONCLUSIONS	Further studies using a larger sample size are needed to confirm the present findings .\
\
###24053621\
OBJECTIVE	To examine mortality and morbidity after prostate biopsy in the intervention arm of the Prostate , Lung , Colorectal and Ovarian Cancer Screening ( PLCO ) trial .\
METHODS	Abstractors from the PLCO trial recorded the types and dates of diagnostic follow-up procedures after positive screens and documented the types and dates of resultant complications .\
METHODS	Cancers and deaths among the participants were tracked .\
METHODS	The mortality rate in the 120-day period after prostate biopsy was compared with a control rate of deaths in the 120-day period after a negative screen in men without biopsy .\
METHODS	Multivariate analysis was performed to control for potential confounders , including age , comorbidities and smoking .\
METHODS	Rates of any complication , infectious and non-infectious complications were computed among men with a negative biopsy .\
METHODS	Multivariate analysis was used to examine the risk factors for complications .\
RESULTS	Of the 37,345 men enrolled in the PLCO trial ( intervention arm ) , 4861 had at least one biopsy after a positive screen and 28,661 had a negative screen and no biopsy .\
RESULTS	The 120-day mortality rate after biopsy was 0.95 ( per 1000 ) , compared with the control group rate of 1.8 ; the multivariate relative risk was 0.49 ( 95 % CI : 0.2-1 .1 ) .\
RESULTS	Among 3706 negative biopsies , the rates ( per 1000 ) of any complication , infectious and non-infections complications were 20.2 , 7.8 and 13.0 , respectively .\
RESULTS	A history of prostate enlargement or inflammation was significantly associated with higher rates of both infectious ( odds ratio [ OR ] = 3.7 ) and non-infectious ( OR = 2.2 ) complications .\
RESULTS	Black race was associated with a higher infectious complications rate ( OR = 7.1 ) and repeat biopsy was associated with lower rates of non-infectious complications ( OR = 0.3 ) .\
CONCLUSIONS	Mortality rates were not found to be higher after prostate biopsy in the PLCO trial and complications were relatively infrequent , with several risk factors identified .\
\
###23807065\
BACKGROUND	The changing scope of women 's roles in combat operations has led to growing interest in women 's deployment experiences and post-deployment adjustment .\
OBJECTIVE	To quantify the gender-specific frequency of deployment stressors , including sexual and non-sexual harassment , lack of social support and combat exposure .\
OBJECTIVE	To quantify gender-specific post-deployment mental health conditions and associations between deployment stressors and posttraumatic stress disorder ( PTSD ) , to inform the care of Veterans returning from the current conflicts .\
METHODS	National mail survey of OEF/OIF Veterans randomly sampled within gender , with women oversampled .\
METHODS	The community .\
METHODS	In total , 1,207 female and 1,137 male Veterans from a roster of all Operation Enduring Freedom/Operation Iraqi Freedom ( OEF/OIF ) Veterans .\
METHODS	Response rate was 48.6 % .\
METHODS	Deployment stressors ( including combat and harassment stress ) , PTSD , depression , anxiety and alcohol use , all measured via self-report .\
RESULTS	Women were more likely to report sexual harassment ( OR = 8.7 , 95 % CI : 6.9 , 11 ) but less likely to report combat ( OR = 0.62 , 95 % CI : 0.50 , 0.76 ) .\
RESULTS	Women and men were equally likely to report symptoms consistent with probable PTSD ( OR = 0.87 , 95 % CI : 0.70 , 1.1 ) and symptomatic anxiety ( OR = 1.1 , 9 5 % CI : 0.86 , 1.3 ) .\
RESULTS	Women were more likely to report probable depression ( OR = 1.3 , 95 % CI : 1.1 , 1.6 ) and less likely to report problematic alcohol use ( OR = 0.59 , 9 5 % CI : 0.47 , 0.72 ) .\
RESULTS	With a five-point change in harassment stress , adjusted odds ratios for PTSD were 1.36 ( 95 % CI : 1.23 , 1.52 ) for women and 1.38 ( 95 % CI : 1.19 , 1.61 ) for men .\
RESULTS	The analogous associations between combat stress and PTSD were 1.31 ( 95 % CI : 1.24 , 1.39 ) and 1.31 ( 95 % CI : 1.26 , 1.36 ) , respectively .\
CONCLUSIONS	Although there are important gender differences in deployment stressors-including women 's increased risk of interpersonal stressors-and post-deployment adjustment , there are also significant similarities .\
CONCLUSIONS	The post-deployment adjustment of our nation 's growing population of female Veterans seems comparable to that of our nation 's male Veterans .\
\
###21211642\
BACKGROUND	Allergy immunotherapy tablet ( AIT ) treatment might be a safe and convenient form of specific immunotherapy but it has not been investigated in North American children and adolescents .\
OBJECTIVE	We sought to investigate the efficacy and safety of timothy grass AIT treatment in North American children/adolescents with grass pollen-induced allergic rhinoconjunctivitis ( ARC ) with or without asthma .\
METHODS	Three hundred forty-five subjects ( 5-17 years old ) were randomized to once-daily grass AIT treatment ( 2,800 bioequivalent allergen units , 75,000 standardized quality tablet , approximately 15 g of Phl p 5 ) or placebo approximately 16 weeks before the 2009 grass pollen season ( GPS ) .\
METHODS	Treatment continued through the GPS .\
METHODS	Daily symptoms and allergy rescue medication use were recorded .\
METHODS	The primary end point was the total combined score ( TCS ) of the daily symptom score ( DSS ) and daily medication score ( DMS ) for the entire GPS .\
METHODS	DSS , DMS , Rhinoconjunctivitis Quality of Life Questionnaire score , and Phl p 5-specific IgG4 and IgE-blocking factor levels were secondary end points .\
METHODS	Safety was assessed through adverse events .\
RESULTS	Eighty-nine percent of subjects were multisensitized .\
RESULTS	TCS , DSS , DMS , and Rhinoconjunctivitis Quality of Life Questionnaire score versus placebo improved 26 % ( P = .001 ) , 25 % ( P = .005 ) , 81 % ( P = .006 ) , and 18 % ( P = .04 ) .\
RESULTS	Phl p 5-specific IgG4 and IgE-blocking factor levels were significantly higher at the peak and end of the GPS ( P < .001 ) .\
RESULTS	Treatment was well tolerated .\
RESULTS	Adverse events were generally mild and transient .\
RESULTS	Although no investigator-assessed systemic allergic reactions were reported , 1 grass AIT-treated subject experienced an event indicating a systemic reaction ( lip angioedema , dysphagia , and cough ) .\
CONCLUSIONS	Use of once-daily timothy grass AIT treatment effectively treats timothy grass ( cross-reactive with Festucoideae grasses ) pollen-induced ARC in North American children 5 years and older .\
CONCLUSIONS	Given its convenient administration , lack of dose build-up requirement , safety profile , and efficacy , AIT treatment might become an important addition to the North American ARC treatment armamentarium .\
\
###15536773\
OBJECTIVE	Alcohol biomarkers are being developed to improve a physician 's ability to identify and intervene with patients with chronic medical problems adversely affected by heavy alcohol use .\
OBJECTIVE	This article reports the findings of a brief intervention trial which included feedback to patients of their carbohydrate-deficient transferrin ( CDT ) test results .\
METHODS	A pilot study was conducted to test the efficacy of brief clinician advice to reduce alcohol use and improve health status in a sample of 151 patients being treated for Type 2 diabetes and hypertension .\
METHODS	The intervention included informing patients of their CDT levels .\
METHODS	The patients were randomized to a usual care or brief intervention group .\
RESULTS	There were no significant differences at baseline between the two groups in alcohol use , CDT levels , addiction rates , age , gender , socioeconomic status or health status measures .\
RESULTS	Following brief intervention , significant differences were observed in the intervention group in alcohol use and CDT : The proportion of heavy drinkers at the 12-month follow-up compared with baseline decreased from 35.8 % to 24.7 % in the intervention group , with no change in the control group ( p < .044 ) .\
RESULTS	CDT levels decreased as well from 2.79 % to 2.41 % ( 16 % change ) in the control group and 3.05 % to 2.35 % ( 28 % change ) in the intervention group , with significantly more intervention-group patients reducing their CDT level by at least 25 % ( p < .006 ) .\
CONCLUSIONS	The study provides new information suggesting brief intervention , combined with feedback on CDT levels , can reduce alcohol use and % CDT in a sample of primary care patients being treated for Type 2 diabetes and hypertension .\
\
###23235130\
OBJECTIVE	To evaluate the long-term outcome of a mother-child project in which mothers ( n = 173 ) with high counts of salivary mutans streptococci were randomly assigned to daily chewing gums containing xylitol ( A ) , chlorhexidine / xylitol/sorbitol ( B ) , or sodium fluoride/xylitol/sorbitol ( C ) for one year , when the child was between 6 and 18 months .\
METHODS	140 of the off-springs were re-examined at the age of 10 years and 204 children of mothers with low counts of salivary mutans streptococci three months after delivery served as positive controls ( D ) .\
METHODS	Caries was scored in the young permanent dentition on enamel ( noncavitated ) and dentine ( cavitated ) levels .\
RESULTS	The long-term attrition rate was 15 % .\
RESULTS	The overall caries prevalence in the combined groups at 10 years of age was 31 % ( 21 % non-cavitated ; 17 % cavitated ) with a mean DS of 0.7 ( SD 1.3 ) .\
RESULTS	No significant differences were found between the three experimental groups ( A-C ) , or when compared with the control group .\
RESULTS	A statistically significant ( p < 0.05 ) positive relationship between the levels of salivary mutans streptococci at 18 months of age and the caries experience at the age of 10 years was disclosed for all groups combined .\
CONCLUSIONS	No beneficial longterm effects of maternal xylitol gum exposure on their children 's dental health were demonstrated when compared with gums containing chlorhexidine and fluoride .\
\
###18274206\
OBJECTIVE	We previously reported that cognitive function improves with thyroxine and that there is a circannual pattern to mood and human TSH during Antarctic residence .\
OBJECTIVE	To extend these findings , we examined the effects of tyrosine and a combined levothyroxine/liothyronine supplement in euthyroid men and women who spent the austral summer ( n = 43 ) and/or winter ( n = 42 ) in Antarctica .\
METHODS	Randomized , placebo-controlled , clinical trial .\
METHODS	Subjects were randomized to receive the following each day for 91.6 + / - 3.2 days in summer and/or 138.0 + / - 3.2 days in winter : ( 1 ) 12g tyrosine mixed in 113g applesauce ; ( 2 ) 50 microg of levothyroxine and 12.5 microg of liothyronine ( T4-T3 Supplement ) ; or ( 3 ) placebo .\
METHODS	Cognitive performance and mood were assessed using the Automatic Neuropsychological Assessment Metric - Isolated and Confined Environments .\
RESULTS	With placebo in summer , mood did not change while TSH decreased by 28 % ; in winter , there was a 136 % degradation in mood ( p < 0.01 ) and TSH increased by 18 % .\
RESULTS	With combined T4-T3 supplement , there was a 51 % degradation in mood in summer compared with placebo ( p < 0.05 ) and TSH decreased by 57 % ; in winter there was a 135 % degradation in mood while TSH was reduced by 26 % ( p < 0.05 ) .\
RESULTS	Tyrosine use in summer was associated with no change in mood and a 30 % decline in TSH , while in winter there was a 47 % improvement in mood and TSH decreased by 28 % along with a 6 % increase in fT3 ( p < 0.05 ) .\
CONCLUSIONS	Administration of tyrosine leads to a significant reduction in serum TSH and improvement in mood in winter compared with placebo , while the combined T4-T3 supplement leads to a worsening of mood in summer and no improvement in winter .\
CONCLUSIONS	There appears to be a seasonal influence on the psychological response to interventions and the relationship to changes in TSH reductions .\
\
###11097670\
OBJECTIVE	We wished to determine which long-acting local anesthetic would produce the least pain on injection for treatment of myofascial pain disorders .\
OBJECTIVE	We compared the pain on intramuscular injection of bupivacaine , ropivacaine , bupivacaine with dexamethasone , ropivacaine with dexamethasone , and needle placement alone .\
METHODS	Thirty volunteers received 5 injections each : ( 1 ) needle only , ( 2 ) bupivacaine 0.5 % , ( 3 ) ropivacaine 0.5 % , ( 4 ) bupivacaine 0.5 % with dexamethasone 0.13 mg/mL , and ( 5 ) ropivacaine 0.5 % with dexamethasone 0.13 mg/mL .\
METHODS	The injections were made in the volunteers ' upper trapezius muscles ; there was a 15-minute interval between injections .\
METHODS	The sequence of injections was randomized by Latin square design .\
METHODS	The intensity of pain was rated on a 0 to 10 cm visual analogue scale ( VAS ) score .\
METHODS	Neither the investigator nor the volunteer was aware of the nature of the injectate .\
METHODS	The pH of the injected solutions was checked to determine if differences in the intensity of pain on injection were due to differences in the pH of the solutions .\
RESULTS	The VAS pain scores were 3.1 + / - 2.4 for needle only , 4.4 + / - 2.8 for bupivacaine , 2.5 + / - 2.0 for ropivacaine , 4.7 + / - 2.7 for bupivacaine/dexamethasone , and 3.7 + / - 2.2 for ropivacaine/dexamethasone .\
RESULTS	The pain on injection of ropivacaine was significantly less than the pain on injection of bupivacaine or bupivacaine/dexamethasone .\
RESULTS	The pH values of the solutions were as follows : ( 1 ) bupivacaine , 5.50 ; ( 2 ) ropivacaine , 5.57 ; ( 3 ) bupivacaine/dexamethasone , 6.64 ; and ( 4 ) ropivacaine/dexamethasone , 6.60 .\
CONCLUSIONS	The pain on intramuscular injection of bupivacaine is significantly more intense than with ropivacaine .\
CONCLUSIONS	The difference in the intensity of the pain on injection between bupivacaine and ropivacaine does not appear to be related to differences in pH. The results of our study have implications on the choice of the local anesthetic used in trigger point injections .\
\
###23489513\
OBJECTIVE	The aim of study was to evaluate the clinical outcomes of PNL in comparison with laparoscopic ureterolithotomy ( LUL ) in proximal ureteral stones larger than 1 cm .\
METHODS	A total of 80 patients who were candidates for treatment of large ureteral stones in our urology center were enrolled in the study between September 2004 and September 2008 .\
METHODS	By using patient randomization , they were assigned into two forty-patient groups ( PNL and LUL ) .\
METHODS	After evaluating the patients with laboratory tests and IVP , PNL was performed under sonography guidance in the prone position or the patients were submitted to classic laparoscopic ureterolithotomy ( LUL ) transperitoneally .\
METHODS	All patients underwent postoperative assessments including KUB and ultrasonography .\
RESULTS	A hundred-percent success was achieved in both groups .\
RESULTS	The mean age of the patients were 39.4 ( 16-63 ) and 35.2 ( 18-57 ) years old in PNL and LUL groups , respectively .\
RESULTS	The mean stone size in PNL group was 14.2 ( 10-25 ) mm and in LUL group was 13.5 ( 10-28 ) mm .\
RESULTS	The duration of the operations were 54.35 ( 50-82 ) minutes , and 82.15 ( 73-180 ) minutes ( P < 0.0001 ) ; and the average hospital stay days were 2.6 ( 2-5 ) and 3.5 ( 3-8 ) days ( p = 0.011 ) in groups PNL and LUL , accordingly .\
RESULTS	The mean Hb decrease in PNL group was 0.9 mg/dL and in LUL group was 0.4 mg/dL ( p = 0.001 ) .\
RESULTS	No statistically significant differences in terms of blood transfusion , fever , ICU admission , and prolonged urinary leakage were detected in both groups .\
CONCLUSIONS	According to our study , percutaneous nephrolithotomy under ultrasonography guidance is comparable with the laparoscopic ureterolithotomy for the treatment of proximal ureteral stones larger than 1 cm .\
\
###12039025\
OBJECTIVE	Clinical evaluation of computed tomography ( CT ) fluoroscopy and comparison with conventional CT guidance for monitoring of percutaneous pulmonary biopsy procedures .\
METHODS	Twenty CT-guided pulmonary biopsy procedures were conducted .\
METHODS	The interventions have prospectively been performed either with CT fluoroscopy or with conventional CT guidance .\
METHODS	About 120 kV and 50 mA with a frame-rate of eight images per second were used for CT fluoroscopy .\
METHODS	Number of pleural needle passages , procedure times , radiation doses and histologic results were analyzed separately for both methods .\
RESULTS	Compared with conventional CT guidance , CT fluoroscopy was associated with less pleural needle passages ( 1.8 + / -0.6 vs. 1.1 + / -0.3 ; P = 0.003 , t-test ) and procedure times were shorter than for conventional CT guidance ( 12.7 + / -2.2 min vs. 26.7 + / -16.4 min ; P = 0.02 ) .\
RESULTS	Analysis of estimated patient related radiation exposure and histologic outcome showed no significant difference between conventional and fluoroscopic CT-guided procedures ( P > 0.05 ) .\
CONCLUSIONS	CT fluoroscopy facilitates guidance of percutaneous pulmonary biopsy procedures .\
CONCLUSIONS	Compared with conventional CT assistance , procedure times are decreased and less pleural needle passages are required .\
CONCLUSIONS	While patient-related radiation exposure is similar , operator-related radiation exposure remains a disadvantage associated with CT fluoroscopy .\
\
###22297080\
BACKGROUND	Although evidence for the efficacy of postoperative antimicrobial prophylaxis is scarce , many patients routinely receive such treatment after major surgeries .\
BACKGROUND	We aimed to compare the incidence of surgical-site infections with intraoperative antimicrobial prophylaxis alone versus intraoperative plus postoperative administration .\
METHODS	We did a prospective , open-label , phase 3 , randomised study at seven hospitals in Japan .\
METHODS	Patients with gastric cancer that was potentially curable with a distal gastrectomy were randomly assigned ( 1:1 ) to receive either intraoperative antimicrobial prophylaxis alone ( cefazolin 1 g before the surgical incision and every 3 h as intraoperative supplements ) or extended antimicrobial prophylaxis ( intraoperative administration plus cefazolin 1 g once after closure and twice daily for 2 postoperative days ) .\
METHODS	Randomisation was stratified using Pocock and Simon 's minimisation method for institution and American Society of Anesthesiologists scores , and Mersenne twister was used for random number generation .\
METHODS	The primary endpoint was the incidence of surgical-site infections .\
METHODS	We assessed non-inferiority of intraoperative therapy with a margin of 5 % .\
METHODS	Analysis was by intention-to-treat .\
METHODS	During hospital stay , infection-control personnel assessed patients for infection , and the principal surgeons were required to check for surgical-site infections at outpatient clinics until 30 days after surgery .\
METHODS	This study is registered with UMIN-CTR , UMIN000000631 .\
RESULTS	Between June 2 , 2005 , and Dec 6 , 2007 , 355 patients were randomly assigned to receive either intraoperative antimicrobial prophylaxis alone ( n = 176 ) or extended antimicrobial prophylaxis ( n = 179 ) .\
RESULTS	Eight patients ( 5 % , 95 % CI 2-9 % ) had surgical-site infections in the intraoperative group compared with 16 ( 9 % , 5-14 ) in the extended group .\
RESULTS	The relative risk of surgical-site infections with intraoperative antimicrobial prophylaxis was 051 ( 022-116 ) , which revealed statistically significant non-inferiority ( p < 00001 ) .\
CONCLUSIONS	Elimination of postoperative antimicrobial prophylaxis did not increase the incidence of surgical-site infections after a gastrectomy .\
CONCLUSIONS	Therefore , this treatment is not recommended after gastric cancer surgery .\
\
###14998609\
OBJECTIVE	We assessed myocardial salvage achieved by reperfusion with percutaneous coronary interventions ( PCI ) and compared stenting with balloon angioplasty ( PTCA ) in patients with acute myocardial infarction ( AMI ) ineligible for thrombolysis .\
BACKGROUND	A substantial proportion of patients with AMI are currently considered ineligible for thrombolysis , and reperfusion treatment is frequently not recommended for them .\
BACKGROUND	It is not known whether these patients benefit from PCI .\
METHODS	The Stent or PTCA for Occluded Coronary Arteries in Patients with Acute Myocardial Infarction Ineligible for Thrombolysis ( STOPAMI-3 ) trial , a randomized , open-label study , included 611 patients with AMI who were ineligible for thrombolysis ( lack of ST-segment elevation on the electrocardiogram , late presentation > 12 h after symptom onset , and contraindications to thrombolysis ) .\
METHODS	Patients were randomly assigned to receive either coronary artery stenting ( n = 305 ) or PTCA ( n = 306 ) .\
METHODS	Scintigraphic myocardial salvage index ( proportion of the initial myocardial perfusion defect that was salvaged by reperfusion ) was the primary end point of the study .\
RESULTS	A considerable myocardial salvage was achieved with both stenting and PTCA .\
RESULTS	In patients assigned to receive stenting , the median size of the salvage index was 0.54 ( 25th and 75th percentiles , 0.29 and 0.87 ) , as compared with a median of 0.50 ( 25th and 75th percentiles , 0.26 and 0.82 ) in the group assigned to receive PTCA ( p = 0.20 ) .\
RESULTS	Mortality at six months was 8.2 % in the group of patients assigned to receive stenting and 9.2 % in the group of patients assigned to receive PTCA ( p = 0.69 ) .\
CONCLUSIONS	Patients with AMI who are currently considered ineligible for thrombolysis by conventional guidelines may greatly benefit from primary PCI .\
CONCLUSIONS	The benefit seems to be comparable when a strategy of stenting is compared with a strategy of PTCA in these patients .\
\
###25677679\
BACKGROUND	QVA149 is a once-daily ( o.d. ) inhaled dual bronchodilator containing a fixed-dose combination of the long-acting 2-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium for the treatment of COPD .\
BACKGROUND	The QUANTIFY study compared QVA149 with a free-dose bronchodilator combination of tiotropium plus formoterol ( TIO+FOR ) in improving health-related quality of life ( HRQoL ) of patients with COPD .\
METHODS	This multicentre , blinded , triple-dummy , parallel-group , non-inferiority study randomised patients aged 40years with moderate-to-severe COPD ( post-bronchodilator forced expiratory volume in 1s ( FEV1 ) 30 % to < 80 % predicted ) to QVA149 110/50g o.d. or TIO 18g o.d. + FOR 12g twice daily ( 1:1 ) for 26weeks .\
METHODS	The primary endpoint was to demonstrate non-inferiority in HRQoL assessed using St George 's Respiratory Questionnaire-COPD ( SGRQ-C ) .\
METHODS	The prespecified non-inferiority margin was 4 units .\
METHODS	Secondary endpoints included Transition Dyspnoea Index ( TDI ) score , pre-dose FEV1 , forced vital capacity ( FVC ) and safety .\
RESULTS	Of the 934 patients randomised ( QVA149 = 476 and TIO+FOR = 458 ) , 87.9 % completed the study .\
RESULTS	At week 26 , non-inferiority was met for SGRQ-C ( QVA149 vs TIO+FOR ; difference : -0.69 units ; 95 % CI -2.31 to 0.92 ; p = 0.399 ) .\
RESULTS	A significantly higher percentage of patients achieved a clinically relevant 1 point improvement in TDI total score with QVA149 ( 49.6 % ) versus TIO+FOR ( 42.4 % ; p = 0.033 ) .\
RESULTS	QVA149 significantly increased pre-dose FEV1 ( +68 mL , 95 % CI 37mL to 100mL ; p < 0.001 ) and FVC ( +74 mL , 95 % CI 24mL to 125mL ; p = 0.004 ) compared with TIO+FOR at week 26 .\
RESULTS	The incidence of adverse events was comparable between both treatments ( QVA149 = 43.7 % and TIO+FOR = 42.6 % ) .\
CONCLUSIONS	QVA149 is non-inferior to TIO+FOR in improving HRQoL , with clinically meaningful and significant improvements in breathlessness and lung function in patients with COPD .\
BACKGROUND	NCT01120717 .\
\
###21907861\
BACKGROUND	Asthma exacerbations during pregnancy are common and can be associated with substantial maternal and fetal morbidity .\
BACKGROUND	Treatment decisions based on sputum eosinophil counts reduce exacerbations in non-pregnant women with asthma , but results with the fraction of exhaled nitric oxide ( F ( E ) NO ) to guide management are equivocal .\
BACKGROUND	We tested the hypothesis that a management algorithm for asthma in pregnancy based on F ( E ) NO and symptoms would reduce asthma exacerbations .\
METHODS	We undertook a double-blind , parallel-group , controlled trial in two antenatal clinics in Australia .\
METHODS	220 pregnant , non-smoking women with asthma were randomly assigned , by a computer-generated random number list , before 22 weeks ' gestation to treatment adjustment at monthly visits by an algorithm using clinical symptoms ( control group ) or F ( E ) NO concentrations ( active intervention group ) used to uptitrate ( F ( E ) NO > 29 ppb ) or downtitrate ( F ( E ) NO < 16 ppb ) inhaled corticosteroid dose .\
METHODS	Participants , caregivers , and outcome assessors were masked to group assignment .\
METHODS	Longacting 2 agonist and minimum dose inhaled corticosteroid were used to treat symptoms when F ( E ) NO was not increased .\
METHODS	The primary outcome was total asthma exacerbations ( moderate and severe ) .\
METHODS	Analysis was by intention to treat .\
METHODS	This study is registered with the Australian and New Zealand Clinical Trials Registry , number 12607000561482 .\
RESULTS	111 women were randomly assigned to the F ( E ) NO group ( 100 completed ) and 109 to the control group ( 103 completed ) .\
RESULTS	The exacerbation rate was lower in the F ( E ) NO group than in the control group ( 0288 vs 0615 exacerbations per pregnancy ; incidence rate ratio 0496 , 95 % CI 0325-0755 ; p = 0001 ) .\
RESULTS	The number needed to treat was 6 .\
RESULTS	In the F ( E ) NO group , quality of life was improved ( score on short form 12 mental summary was 569 [ 95 % CI 502-593 ] in F ( E ) NO group vs 542 [ 461-576 ] in control group ; p = 0037 ) and neonatal hospitalisations were reduced ( eight [ 8 % ] vs 18 [ 17 % ] ; p = 0046 ) .\
CONCLUSIONS	Asthma exacerbations during pregnancy can be significantly reduced with a validated F ( E ) NO-based treatment algorithm .\
BACKGROUND	National Health and Medical Research Council of Australia .\
\
###12944028\
BACKGROUND	Deficiency of nitric oxide ( NO ) production has been implicated in the pathogenesis of increased pulse wave reflection associated with systolic hypertension .\
BACKGROUND	We investigated the effects on systolic blood pressure ( BP ) and pulse wave contour of two nitrate donors , isosorbide mononitrate ( ISMN ) and L-arginine .\
METHODS	The subjects were 14 elderly patients chronically treated with antihypertensive agents .\
METHODS	In seven of the subjects , agents causing angiotensin II ( AII ) inhibition ( angiotensin-converting enzyme [ ACE ] inhibitor or AT ( 1 ) receptor antagonist , or both ) were used .\
METHODS	Study entry required systolic BP of 150 to 200 mm Hg , and aortic pulse wave augmentation more than 15 mm Hg .\
METHODS	Pharmacodynamic responses to ISMN , L-arginine , and ISMN plus L-arginine , were assessed in double-blind crossover studies by standard sphygmomanometry and applanation tonometry .\
RESULTS	Peripheral systolic BP , aortic systolic BP , and the aortic augmentation index were decreased ( P < .001 ) by ISMN , irrespective of AII inhibition .\
RESULTS	L-arginine enhanced these effects ( P < .001 ) in the subjects without AII inhibition , but not in those receiving AII inhibitors .\
RESULTS	Given without ISMN or AII inhibitors , L-arginine decreased peripheral systolic BP , but to a lesser extent than ISMN .\
CONCLUSIONS	L-arginine has potential value as an adjunct to ISMN in combination with antihypertensive therapy in elderly patients with systolic hypertension .\
CONCLUSIONS	However , when given with single-dose ISMN , its vasodilator activity may overlap with that of AII inhibitors .\
CONCLUSIONS	Future studies of L-arginine in conjunction with chronic continuous ISMN dosing are warranted .\
\
###12173195\
BACKGROUND	In children , sevoflurane anaesthesia is associated with postanaesthetic agitation , which is treated mainly with opioids .\
BACKGROUND	We compared the effectiveness of epidural and i.v. clonidine in the prevention of this postanaesthetic agitation .\
METHODS	Eighty children aged 3-8 yr ( ASA I-II ) received standardized general anaesthesia with inhaled sevoflurane and caudal epidural block with 0.175 % bupivacaine 1 ml kg-1 for minor surgery .\
METHODS	The children were assigned randomly to four groups : ( I ) clonidine 1 microgram kg-1 added to caudal bupivacaine ; ( II ) clonidine 3 micrograms kg-1 added to caudal bupivacaine ; ( III ) clonidine 3 micrograms kg-1 i.v. and caudal bupivacaine ; and ( IV ) caudal block with bupivacaine , no clonidine ( control ) .\
METHODS	A blinded observer assessed the behaviour of the children during the first postoperative hour .\
METHODS	Secondary end-points were the time to fitness for discharge from the postanaesthesia care unit , and haemodynamic and respiratory variables .\
RESULTS	The incidence of agitation was 22 , 0 , 5 and 39 % in groups I , II , III and IV respectively ( P < 0.05 for groups II and III compared with group IV ) .\
RESULTS	During the first hour after surgery , patients in groups II and III had significantly lower scores for agitation than group IV patients .\
RESULTS	Time to fitness for discharge did not differ between the four groups .\
CONCLUSIONS	Clonidine 3 micrograms kg-1 prevented agitation after sevoflurane anaesthesia , independently of the route of administration .\
CONCLUSIONS	The effect of clonidine appears to be dose-dependent , as an epidural dose of 1 microgram kg-1 failed to reduce it .\
\
###24325834\
BACKGROUND	Pain is among the most cited negative effects of orthodontic treatment .\
BACKGROUND	Non-steroidal anti-inflammatory drugs seem to be an effective option for minimizing this but can have adverse effects on tooth movement owing to their ability to block prostaglandin synthesis .\
BACKGROUND	Acetaminophen has been suggested as the analgesic of choice during orthodontic treatment as it showed no effect on orthodontic tooth movement in previous animal studies .\
BACKGROUND	The purpose of this study was to compare the effects of ibuprofen and acetaminophen on the prostaglandin E2 ( PGE2 ) levels of the gingival crevicular fluid ( GCF ) during orthodontic tooth movement in human subjects .\
METHODS	A total of 42 patients ( mean age 184.5 years ) were randomly divided into three equal groups : ibuprofen , acetaminophen , and control groups .\
METHODS	Maxillary canines were distalized with 150 g of force delivered by NiTi coil springs .\
METHODS	GCF samples were obtained before ( baseline ) and after spring activation at 24 , 48 , and 168 h.\
METHODS	The PGE2 content of the GCF was determined using enzyme-linked immunosorbent assay .\
RESULTS	PGE2 levels in all groups increased significantly by 24 and 48 h of force application and decreased to baseline levels by 168 h. No significant difference was found between the acetaminophen and control groups at any time point .\
RESULTS	There was a significant decrease in PGE2 levels in the ibuprofen group at 24 and 48 h when compared to the other two groups .\
CONCLUSIONS	Acetaminophen showed no significant effect on prostaglandin synthesis and may be the safe choice compared to ibuprofen for relieving pain associated with orthodontic tooth movement .\
\
###10334433\
OBJECTIVE	The aim of the study was to investigate whether omega-3 fatty acids ( n-3 FA ) reduce the occurrence of restenosis after percutaneous transluminal coronary angioplasty .\
BACKGROUND	Meta-analyses have shown significant reduction of restenosis after coronary angioplasty upon supplementation with n-3 FA .\
METHODS	In a prospective , placebo-controlled , double-blind study , 500 patients were randomly allocated to treatment with n-3 FA ( Omacor , Pronova AS , Oslo , Norway ) 5.1 g/day or corn oil ( placebo ) starting at least two weeks prior to elective coronary angioplasty .\
METHODS	The treatment was continued until restenosis evaluation by quantitative coronary angiography after six months .\
METHODS	Stenosis was defined as a minimal luminal diameter ( MLD ) < 40 % of the reference diameter .\
METHODS	Successful coronary angioplasty was defined as > or = 20 % acute gain in MLD and a residual stenosis < 50 % .\
METHODS	Restenosis was defined as > or = 20 % late loss of diameter and stenosis > 50 % or an increase in stenosis of > or = 0.7 mm .\
METHODS	Three-hundred ninety-two patients fulfilled the criteria for initial stenosis and successful coronary angioplasty , and , except four patients who died , none were lost for follow-up .\
RESULTS	Restenosis occurred in 108/266 ( 40.6 % ) of the treated stenoses in the Omacor group and in 93/263 ( 35.4 % ) in the placebo group ( odds ratio [ OR ] 1.25 , 95 % confidence interval [ CI ] [ 0.87-1 .80 ] p = 0.21 ) .\
RESULTS	In the Omacor group one or more restenoses occurred in 90/196 ( 45.9 % ) patients as compared with 86/192 ( 44.8 % ) in the placebo group ( OR 1.05 , 95 % CI [ 0.69-1 .59 ] p = 0.82 ) .\
CONCLUSIONS	Supplementation with 5.1 g n-3 FA/day for six months , initiated at least two weeks prior to coronary angioplasty did not reduce the incidence of restenosis .\
\
###12686036\
BACKGROUND	The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome .\
BACKGROUND	No study , however , has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease ( CHD ) in hypertensive patients who are not conventionally deemed dyslipidaemic .\
METHODS	Of 19342 hypertensive patients ( aged 40-79 years with at least three other cardiovascular risk factors ) randomised to one of two antihypertensive regimens in the Anglo-Scandinavian Cardiac Outcomes Trial , 10305 with non-fasting total cholesterol concentrations 6.5 mmol/L or less were randomly assigned additional atorvastatin 10 mg or placebo .\
METHODS	These patients formed the lipid-lowering arm of the study .\
METHODS	We planned follow-up for an average of 5 years , the primary endpoint being non-fatal myocardial infarction and fatal CHD .\
METHODS	Data were analysed by intention to treat .\
RESULTS	Treatment was stopped after a median follow-up of 3.3 years .\
RESULTS	By that time , 100 primary events had occurred in the atorvastatin group compared with 154 events in the placebo group ( hazard ratio 0.64 [ 95 % CI 0.50-0 .83 ] , p = 0.0005 ) .\
RESULTS	This benefit emerged in the first year of follow-up .\
RESULTS	There was no significant heterogeneity among prespecified subgroups .\
RESULTS	Fatal and non-fatal stroke ( 89 atorvastatin vs 121 placebo , 0.73 [ 0.56-0 .96 ] , p = 0.024 ) , total cardiovascular events ( 389 vs 486 , 0.79 [ 0.69-0 .90 ] , p = 0.0005 ) , and total coronary events ( 178 vs 247 , 0.71 [ 0.59-0 .86 ] , p = 0.0005 ) were also significantly lowered .\
RESULTS	There were 185 deaths in the atorvastatin group and 212 in the placebo group ( 0.87 [ 0.71-1 .06 ] , p = 0.16 ) .\
RESULTS	Atorvastatin lowered total serum cholesterol by about 1.3 mmol/L compared with placebo at 12 months , and by 1.1 mmol/L after 3 years of follow-up .\
CONCLUSIONS	The reductions in major cardiovascular events with atorvastatin are large , given the short follow-up time .\
CONCLUSIONS	These findings may have implications for future lipid-lowering guidelines .\
\
###23828383\
OBJECTIVE	In the present study , the effect of chemo and radio therapies on serum trace elements content and antioxidant activity in blood serum of cervical cancer patients was evaluated .\
METHODS	Among 104 cervical cancer patients selected for the present study , 54 and 50 patients were treated with chemo - and radiotherapy respectively .\
METHODS	Plasma Se , Zn , Cu and some enzymatic antioxidants activities were estimated in serum before and after the treatment .\
RESULTS	The decreased levels of serum trace elements , glutathione peroxidase activity and total antioxidant capacity , and increased malondialdehyde , glutathion reductase was observed in cervical cancer patients when compared to healthy controls .\
RESULTS	The increased concentration of serum Se , Zn was observed in patients treated with chemotherapy .\
RESULTS	Simultaneously there was a significant ( P < 0.001 ) increase in glutathione peroxidase and total antioxidant capacity , and significant decrease ( P < 0.05 ) in malondialdehyde and glutathion reductase levels in the serum of patients treated with chemotherapy compared to the patients treated with radiotherapy .\
CONCLUSIONS	The results demonstrated that chemotherapy but not radiotherapy results in significant increase in the trace elements levels and antioxidant activities in blood serum of cervical cancer patients .\
\
###10785215\
OBJECTIVE	To compare the following IVF protocols : a short protocol and long protocols starting on day 2 or day 21 .\
OBJECTIVE	All protocols used recombinant FSH ( rFSH ) for ovarian stimulation .\
METHODS	Prospective , randomized study .\
METHODS	An assisted reproduction unit at a university center .\
METHODS	Patients undergoing IVF ( n = 150 ) were treated according to one of the three treatment protocols allocated by a random method .\
METHODS	All patients used buserelin acetate and rFSH .\
METHODS	Patients began the long protocol on day 2 ( group 1 ) or day 21 ( group 2 ) of the cycle .\
METHODS	Patients in group 3 began the short protocol on day 2 of the cycle .\
METHODS	Ovarian response , implantation rates , and pregnancy rates ( PRs ) .\
RESULTS	Patients treated with the short protocol ( group 3 ) were stimulated in a shorter time , required less rFSH , and achieved higher E ( 2 ) levels .\
RESULTS	The numbers of follicles , oocytes , and embryos were similar in all three groups .\
RESULTS	The implantation rates were similar in groups 1 and 2 ( 11.8 % and 13.3 % , respectively ) , and both were higher than in group 3 ( 4.1 % ) .\
RESULTS	Clinical PRs per oocytes retrieved were 19.6 % , 18.6 % , and 8.3 % in groups 1 , 2 , and 3 , respectively .\
CONCLUSIONS	The implantation rate was significantly higher with the long protocols than with the short protocol , with a tendency for a higher PR as well .\
\
###23295056\
BACKGROUND	Management of lamivudine-resistant chronic hepatitis B ( CHB ) remains challenging , as inappropriate choice of treatment may cause multidrug resistance .\
BACKGROUND	Until now , randomized trials directly comparing adding adefovir and switching to entecavir monotherapy have not been reported .\
OBJECTIVE	This multicentre prospective randomized study was designed to compare the efficacy of these two strategies .\
METHODS	Two hundred and nineteen lamivudine-resistant CHB patients were randomized to either adefovir-lamivudine combination group or entecavir monotherapy group ( n = 110 vs. 109 ) , and followed up for 24 months .\
RESULTS	One hundred and eighty patients completed this study .\
RESULTS	At month 24 , virological response rate [ hepatitis B virus ( HBV ) DNA < 60 IU/ml ] was higher in the adefovir-lamivudine combination group compared with entecavir group ( 56.7 % vs. 40 % , P = 0.025 ) , although biochemical and serological response rates were not significantly different .\
RESULTS	Genotypic resistance ( 9.2 % vs. 24.6 % , P = 0.005 ) and combined viral breakthrough ( 2.0 % vs. 17.6 % , P < 0.001 ) were more frequent in the entecavir group .\
RESULTS	However , by subgroup analysis , virological response rates were not significantly different between the two therapies in HBeAg-positive patients ( 44.9 % vs. 35.7 % , P = 0.268 ) or in patients with high baseline HBV DNA ( 7 log IU/ml ) ( 40.7 % vs. 31.3 % , P = 0.320 ) at month 24 .\
CONCLUSIONS	This study showed that adefovir-lamivudine combination provides significantly higher antiviral efficacy and the lower resistance rate compared with the entecavir monotherapy in the management of lamivudine-resistant CHB .\
CONCLUSIONS	However , it had limited efficacy in HBeAg-positive patients or in patients with high baseline HBV DNA .\
\
###23889649\
OBJECTIVE	To clarify whether a short-term whole body vibration ( WBV ) training has an effect on lean mass ( LM ) in the elderly .\
METHODS	49 non-institutionalized elderly ( 20 men ) participated in the study .\
METHODS	Participants who met the inclusion criteria were randomly assigned to the WBV or control group .\
METHODS	A total of 24 elderly trained squat positioned on a vibration platform 3 times per week for 11 weeks .\
METHODS	LM at the whole body , upper and lower limbs was assessed by dual-energy X-ray absorptiometry .\
METHODS	Two-way repeated measures ANOVA was used to determine the effects of the intervention on the studied variables and also to determinate the changes within group throughout the intervention period including age and height as covariates .\
RESULTS	11 weeks of WBV training led to no changes in none of the LM parameters .\
CONCLUSIONS	A short-term WBV therapy is not enough to cause significant changes on LM in non-institutionalized seniors .\
\
###11742194\
BACKGROUND	Proton pump inhibitor ( PPI ) monotherapy is commonly continued for 3 weeks after Helicobacter pylori eradication with PPI-based triple therapy regimens to ensure duodenal ulcer ( DU ) healing .\
BACKGROUND	This randomized , double-blind , multicentre study evaluated whether only 1 week of triple therapy with the new PPI esomeprazole was sufficient to ensure high rates of ulcer healing and H. pylori eradication .\
METHODS	A total of 446 H. pylori-positive patients with active DU received twice daily treatment with esomeprazole 20 mg ( n = 222 ) or omeprazole 20 mg ( n = 224 ) in combination with amoxicillin 1 g and clarithromycin 500 mg for 1 week ( EAC and OAC , respectively ) .\
METHODS	Patients in the OAC group then received 3 weeks ' monotherapy with omeprazole 20 mg once daily ; those treated with EAC received placebo .\
METHODS	Ulcer healing was assessed by endoscopy on completion of therapy and H. pylori status was assessed by ( 13 ) C-urea breath testing and histology 4-6 weeks later .\
RESULTS	Ulcer healing rates ( 95 % CI ) for intention-to-treat and per-protocol populations were : EAC + placebo 91 % ( 87-95 % ) and 94 % ( 90-97 % ) ; OAC + omeprazole 92 % ( 88-95 % ) and 96 % ( 92-98 % ) .\
RESULTS	Corresponding H. pylori eradication rates were : EAC + placebo 86 % ( 81-90 % ) and 89 % ( 84-93 % ) ; OAC + omeprazole 88 % ( 83-92 % ) and 90 % ( 85-93 % ) .\
RESULTS	Both eradication regimens were well tolerated , and patient compliance was high .\
CONCLUSIONS	A 1-week regimen of esomeprazole-based triple therapy is sufficient for DU healing and H. pylori eradication in patients with DU disease .\
\
###8623811\
OBJECTIVE	Our purpose was to investigate the efficacy of P6 acupressure in reducing or relieving symptoms of nausea with or without vomiting and retching during pregnancy .\
METHODS	Symptomatic pregnant volunteers ( n = 161 ) participated in a 7-day community-based clinical trial .\
METHODS	All participants were assigned to one of three groups ( i.e. , P6 acupressure , placebo [ acupressure bands inappropriately placed ] , or control ) on the basis of a process of blocked randomization .\
METHODS	Data were analyzed by error bar charts and analysis of variance of difference scores .\
RESULTS	Of 161 women , 149 ( 92.5 % ) completed the protocol .\
RESULTS	Irrespective of group assignment , participants reported significant decreases in nausea ( p < 0.0009 ) and vomiting or retching ( p < 0.0009 ) .\
RESULTS	However , there was no differential treatment effect as a result of acupressure .\
CONCLUSIONS	There was no apparent medical benefit from the use of P6 acupressure .\
CONCLUSIONS	Our findings differ from other recently published studies that did not include a control group .\
\
###16154019\
BACKGROUND	No prospective trial-based data are available for incremental cost-effectiveness of drug-eluting stents ( DES ) compared with bare-metal stents ( BMS ) in unselected patients , as treated in everyday practice .\
METHODS	The Basel stent cost-effectiveness trial ( BASKET ) included 826 consecutive patients treated with angioplasty and stenting for 1281 de-novo lesions , irrespective of indication for angioplasty .\
METHODS	Patients were randomised to one of two DES ( Cypher , n = 264 ; Taxus , n = 281 ) or to a cobalt-chromium-based BMS ( Vision , n = 281 ) and followed up for 6 months for occurrence of major adverse cardiac events and costs .\
METHODS	Analysis was by intention-to-treat .\
METHODS	The primary endpoint was cost-effectiveness after 6 months , with effectiveness defined as reduction of major adverse cardiac events .\
RESULTS	Cardiac death , myocardial infarction , or target vessel revascularisation occurred in 39 of 544 ( 7.2 % ) patients with DES and 34 of 280 ( 12.1 % ) with BMS ( odds ratio 0.56 , 95 % CI 0.35-0 .91 ; p = 0.02 ) , without significant differences between the two DES .\
RESULTS	Total costs at 6 months were higher with DES ( mean 10,544 , SD 6849 ) than with BMS ( 9639 , 9067 ; p < 0.0001 ) ; higher stent costs of DES were not compensated for by lower follow-up costs .\
RESULTS	Incremental cost-effectiveness ratio of DES compared with BMS to avoid one major event was 18,311 , and costs per quality-adjusted life-year gained were more than 50 000 .\
RESULTS	Subgroup analyses showed that DES were more cost-effective for elderly patients in specific high-risk groups .\
CONCLUSIONS	In a real-world setting , use of DES in all patients is less cost effective than in studies with selected patients .\
CONCLUSIONS	Use of these stents could be restricted to patients in high-risk groups .\
\
###16340712\
OBJECTIVE	We sought to compare the therapeutic benefits of ThermaCare Heat Wrap combined with an education program to an education-only program on reducing pain and disability from acute work-related low back pain .\
METHODS	Forty-three eligible patients , aged 20 to 62 years who presented to an occupational injury clinic , were randomized into one of two intervention arms : 1 ) education regarding back therapy and pain management alone or 2 ) education regarding back therapy and pain management combined with three consecutive days of topical heat therapy ( 104 degrees F or 40 degrees C for 8 hours ) .\
METHODS	The primary endpoints in this trial were measures of pain intensity and pain relief levels obtained approximately four times per day for the three consecutive working days of treatment , followed by measures of pain intensity and pain relief levels obtained in three follow-up visits at day 4 and 14 from treatment initiation .\
METHODS	The secondary measures were overall impairment due to injury and disability caused by low back pain assessed at Intake , Visit 2 ( day 4 ) , 3 ( day 7 ) , and 4 ( day 14 ) .\
CONCLUSIONS	A total of 18 individuals enrolled in the education-only group and 25 in the treatment group completed the intervention and all follow-up visits .\
CONCLUSIONS	The general linear model adjusting for age , sex , baseline pain intensity , and pain medication indicated that the topical heat therapy had significantly reduced pain intensity , increased pain relief , and improved disability scores during and after treatment .\
\
###12141723\
BACKGROUND	In addition to their bronchodilating effect , long-acting inhaled beta-agonists have recently been shown to have some anti-inflammatory properties .\
OBJECTIVE	The purpose of this study was to evaluate the effect of formoterol on inflammatory mediators in children .\
METHODS	In this double-blind , randomized , placebo-controlled trial , 34 children , aged 6 to 18 years , with moderate atopic asthma , were randomly allocated to receive formoterol or matching placebo for 4 weeks .\
METHODS	The primary endpoint of this study was to determine changes in serum levels of inflammatory markers after treatment with formoterol ; secondary endpoints included clinical efficacy and bronchial hyperreactivity .\
METHODS	The following parameters were measured : symptom score , forced expiratory volume in 1 second ( FEV1 ) , provocative concentration of histamine causing a 20 % fall in FEV1 ( PC20 ) for histamine and peripheral blood eosinophil count , serum levels of eosinophil cationic protein ( ECP ) , soluble receptor of interleukin-2 ( sIL-2R ) , level of interleukin-4 ( IL-4 ) , level of soluble intercellular adhesion molecule-1 ( ICAM-1 ) , and immunoglobulin E ( IgE ) level before and after treatment .\
RESULTS	Compared with placebo , treatment with formoterol significantly improved lung function .\
RESULTS	The mean value of FEV1 changed from 74 % of predicted value before treatment to 80 % of predicted value after treatment ( P < 0.001 ) .\
RESULTS	The mean concentration of eosinophil blood count before and after treatment was 379 and 310 cells/mm3 ( P = 0.035 ) ; ECP was 93 and 83 mcg/L ; and serum IL-4 was 0.13 and 0.11 pg/mL ( P = 0.001 ) .\
RESULTS	There was no significant difference between formoterol and placebo recipients in PC20H , and serum concentration of sIL-2R , sICAM-1 , or IgE after treatment .\
RESULTS	The group that received formoterol showed improvement in pulmonary function as measured by FEV1 ( P < 0.001 ) , and PC20H ( P = 0.04 ) after 4 weeks of treatment .\
RESULTS	These patients also showed improvement of clinical symptoms ( P < 0.001 ) .\
RESULTS	Serum marker measurements in the formoterol group showed decreased concentrations of eosinophil blood count , ECP , and IL-4 , but there was no difference in before and after measurements of sIL-2R , sICAM-1 , and IgE .\
CONCLUSIONS	These results indicate that formoterol has measurable anti-inflammatory properties and can diminish asthma symptoms and bronchial hyperreactivity .\
\
###16297472\
BACKGROUND	Low-carbohydrate , ketogenic diets ( LCKD ) are effective for weight loss , but concerns remain regarding cardiovascular risk .\
BACKGROUND	The purpose of this study was to determine the effect of an LCKD program on serum lipoprotein subclasses .\
METHODS	This was a randomized , two-arm clinical trial in an outpatient research clinic involving overweight , hyperlipidemic community volunteers motivated to lose weight .\
METHODS	Subjects were randomized to either an LCKD ( n = 59 ) and nutritional supplementation ( including fish , borage and flaxseed oil ) , or a low-fat , reduced-calorie diet ( LFD , n = 60 ) .\
METHODS	The main outcomes were fasting serum lipoprotein subclasses determined by nuclear magnetic resonance analysis .\
RESULTS	The mean age of subjects was 44.9 years , the mean BMI was 34.4 kg/m ( 2 ) , and 76 % were women .\
RESULTS	Comparing baseline to 6 months , the LCKD group had significant changes in large VLDL ( -78 % ) , medium VLDL ( -60 % ) , small VLDL ( -57 % ) , LDL particle size ( +2 % ) , large LDL ( +54 % ) , medium LDL ( -42 % ) , small LDL ( -78 % ) , HDL particle size ( +5 % ) , large HDL ( +21 % ) , and LDL particle concentration ( -11 % ) .\
RESULTS	Compared with the LFD group , the LCKD group had greater reductions in medium VLDL ( p = 0.01 ) , small VLDL ( p = 0.01 ) and medium LDL ( p = 0.02 ) , and greater increases in VLDL particle size ( p = 0.01 ) , large LDL ( p = 0.004 ) , and HDL particle size ( p = 0.05 ) .\
CONCLUSIONS	The LCKD with nutritional supplementation led to beneficial changes in serum lipid subclasses during weight loss .\
CONCLUSIONS	While the LCKD did not lower total LDL cholesterol , it did result in a shift from small , dense LDL to large , buoyant LDL , which could lower cardiovascular disease risk .\
\
###24953576\
OBJECTIVE	To compare the efficacy of glycerin suppository versus no suppository in preterm very-low-birthweight neonates for improving feeding tolerance .\
METHODS	Randomized controlled trial .\
METHODS	Level III neonatal unit from Mumbai , India .\
METHODS	50 very-low-birthweight ( birth weight between 1000 to 1500 grams ) preterm ( gestational age between 28 to 32 weeks ) neonates randomized to glycerine suppository ( n = 25 ) or no intervention ( n = 26 ) .\
METHODS	Glycerin suppository ( 1g ) once a day from day-2 to day-14 of life or no suppository , along with intermittent oral feeds and standardized care .\
METHODS	Time required to achieve full enteral feeds ( 180 mL/kg/d ) .\
RESULTS	Baseline characteristics of neonates like gestational age , birthweight , gender and age at the time of introduction of feeds were comparable in both groups .\
RESULTS	The mean ( SD ) duration to reach full enteral feed was 11.90 ( 3.1 ) days in glycerin suppository group and was not significantly different ( P = 0.58 ) from control group , [ 11.33 ( 3.57 ) days ] .\
RESULTS	Glycerin suppository group regained birth weight 2 days earlier than control group but this difference was not significant ( P = 0.16 ) .\
RESULTS	There was no significant difference in duration of hospital stay or occurrence of necrotizing enterocolitis amongst the two study groups .\
CONCLUSIONS	Once daily application of glycerin suppository does not accelerate the achievement of full feeds in preterm very-low-birthweight neonates .\
\
###16251566\
OBJECTIVE	This study compares thermodilution cardiac output ( TD-CO ) and esophageal Doppler cardiac output ( ED-CO ) during periods of hemodynamic stability and after heart stabilization during off-pump coronary artery bypass ( OPCAB ) surgery .\
METHODS	After Institutional Review Board approval , 58 patients undergoing OPCAB had simultaneous comparison of TD-CO and ED-CO at three time periods .\
METHODS	Measurements were recorded , in a blinded manner , after probe insertion ( T0 ) , immediately before and after ( T1 , T2 ) heart displacement and before starting any pharmacological treatment ( if needed ) to maintain systolic blood pressure to its value before heart mobilization .\
METHODS	Measurements were also taken before sternal closure ( Tfinal ) .\
RESULTS	Three hundred and two pairs of data were analyzed using the Bland and Altman method .\
RESULTS	Bias , standard deviation ( SD ) of the bias ( precision ) , and degree of agreement ( bias + / - 2 SD ) were calculated .\
RESULTS	Based on published literature , we considered that the highest degree of agreement should be < 0.5 L.min ( -1 ) to consider both methods as interchangeable .\
RESULTS	At T0 , bias and SD of bias between TD-CO and ED-CO were -0.1 + / - 1.0 L.min ( -1 ) .\
RESULTS	Immediately before heart stabilization , bias + / - SD was 0.6 + / - 1.0 L.min ( -1 ) and after heart displacement , 0.5 + / - 0.8 L.min ( -1 ) .\
RESULTS	At Tfinal , bias + / - SD was 0.7 + / - 0.7 L.min ( -1 ) .\
CONCLUSIONS	Because the degree of agreement was > 0.5 L.min ( -1 ) at all measurement periods except T0 , we conclude that TD and ED are not interchangeable at any time during OPCAB surgery .\
\
###20447161\
OBJECTIVE	To determine ( i ) the prevalence of impaired olfaction in a group of individuals post-laryngectomy , and ( ii ) whether intensive , clinician-supported training of the Nasal Airflow Inducing Manoeuvre ( NAIM ) was more effective at improving olfactory acuity than intensive , home practice over a 6-week period .\
METHODS	Cohort study followed by a randomised control trial of two treatments over a 6-week period with a 3-month review .\
METHODS	Olfactory acuity was evaluated in 43 laryngectomy patients .\
METHODS	Results revealed 95 % had impaired olfactory acuity ( anosmic or hyposmic ) .\
METHODS	From this group 40 eligible participants with reduced olfactory acuity were then randomly assigned into either the clinician-supported or home practice treatment group .\
METHODS	Olfactory acuity and functional impact measures relating to olfactory acuity ( participation restriction , wellbeing/distress ) .\
RESULTS	Although olfactory acuity significantly improved in both treatment groups following 6 weeks of therapy , results indicated significantly greater improvement in the clinician-assisted group immediately post-treatment .\
RESULTS	By 3 months , post-treatment effects were maintained .\
RESULTS	Both modes of treatment improved levels of patient wellbeing , however , only the clinician-assisted mode made a significant positive effect on levels of perceived participation restriction .\
CONCLUSIONS	Reduced olfactory acuity is prevalent post-laryngectomy .\
CONCLUSIONS	Olfactory acuity can be significantly improved using either 6 weeks of clinician-assisted or home practice using the NAIM manoeuvre , although the current data suggest that intensive clinician-assisted treatment can assist patients to improve more rapidly and have a positive impact on functional state .\
\
###16023065\
OBJECTIVE	To compare optical quality , visual function , corneal shape , ocular wavefront aberrations , and patient-reported symptoms and satisfaction after laser in situ keratomileusis ( LASIK ) with two different excimer lasers .\
METHODS	Prospective randomized clinical trial .\
METHODS	In an institutional practice setting , 60 eyes of 30 patients with low to moderate myopia were randomized to receive LASIK in one eye with the Technolas 217A ; the other eye was treated with the VISX S3 .\
METHODS	Patients were followed for 6 months after surgery .\
METHODS	The primary outcome measure was best spectacle-corrected visual acuity .\
RESULTS	At 6 months , the mean best-spectacle corrected high contrast visual acuity was similar between the two treatment groups : mean difference ( 95 % confidence interval ) was -0.01 logarithm of minimal angle of resolution ( logMAR ) ( -0.03 to +0.01 logMAR ) .\
RESULTS	Uncorrected visual acuity differences were also not significant .\
RESULTS	The difference in residual spherical equivalent subjective refractive error between treatment groups was -0.15 diopter ( -0.34 to +0.05 diopter ) .\
RESULTS	Spherical aberration increased in both groups after treatment , and the change in root mean square ( RMS ) ocular wavefront error was greater in the VISX group by +0.07 microm ( +0.03 to +0.11 microm ) .\
RESULTS	After LASIK , corneal curvature was steeper in the midperipheral region among VISX-treated eyes by +1.39 diopters ( +2.06 to +0.72 diopters ) .\
RESULTS	There were no patient-reported differences in satisfaction between eyes .\
CONCLUSIONS	There were no significant differences in visual acuity or refractive outcomes attributed to either laser under any of the conditions measured .\
CONCLUSIONS	There was also no significant difference in patient-reported symptoms , satisfaction with treatment , or eye preference associated with either laser .\
CONCLUSIONS	Additional study is needed to establish the importance of differences in higher-order optical aberrations and corneal shape that we observed in these two treatment groups .\
\
###14511969\
OBJECTIVE	To study whether proactive educational counselling , in addition to routine clinical care , reduces psychological morbidity and improves quality of life and client satisfaction among women who suffer suboptimal outcomes during childbirth .\
METHODS	A randomised controlled trial .\
METHODS	Obstetric unit of a tertiary teaching hospital .\
METHODS	Women who had unexpected antenatal , intrapartum or postpartum events leading to suboptimal outcomes during pregnancy and childbirth .\
METHODS	Educational counselling provided by a trained research nurse in the postnatal ward after delivery .\
METHODS	Women in the control group received routine clinical care .\
METHODS	The Hospital Anxiety and Depression Scale , the General Health Questionnaire and the Clinical Global Impression ( before and after counselling , at six weeks and six months post-delivery ) and the World Health Organisation Quality of Life scale ( WHO-QOL ) ( at six weeks and six months post-delivery ) .\
RESULTS	There was no significant difference in psychological morbidity , quality of life or client satisfaction between the counselling group and the control group .\
RESULTS	Participants who underwent elective caesarean section and who had the educational counselling had significantly lower depression scores [ mean 2.6 ( SD 2.6 ) ] compared with those receiving routine care [ mean 3.9 ( SD 3.2 ) ] .\
RESULTS	On the other hand , educational counselling may have deleterious effect to women 's quality of life in those who had instrumental delivery .\
RESULTS	Participants allocated to the counselling group had a lower mean score 68 ( SD 13 ) in the physical domain of WHO-QOL than those in the intervention group 74 ( SD 13 ) .\
CONCLUSIONS	Educational counselling , given on top of routine clinical care , does not give additional beneficial effects on the psychological wellbeing and quality of life of women who encountered suboptimal outcomes during pregnancy .\
\
###22222996\
OBJECTIVE	To evaluate the safety and effectiveness of the LipiFlow System compared to the iHeat Warm Compress ( WC ) for adults with meibomian gland dysfunction ( MGD ) .\
METHODS	This was a non-significant risk , prospective , open-label , randomized , crossover multicenter clinical trial .\
METHODS	One hundred thirty-nine subjects were randomized between LipiFlow ( n = 69 ) and WC control ( n = 70 ) .\
METHODS	Subjects in the LipiFlow group received a 12-minute LipiFlow treatment and were reexamined at 1 day , 2 weeks and 4 weeks .\
METHODS	Control subjects received a 5-minute iHeat treatment with instructions to perform the same treatment daily for 2 weeks .\
METHODS	At 2 weeks , they crossed over ( LipiFlow Crossover ) and received the LipiFlow treatment .\
METHODS	Effectiveness parameters : meibomian gland ( MG ) assessment , tear break-up time ( TBUT ) and dry eye symptoms .\
METHODS	Safety parameters : adverse events , ocular health exam , ocular surface staining , intraocular pressure , visual acuity and discomfort .\
RESULTS	LipiFlow resulted in significant improvement ( P < 0.05 ) in MG secretion at 2 and 4 weeks ( mean standard deviation at baseline = 6.3 3.5 ; 2 weeks = 14.3 8.7 ; 4 weeks = 16.7 8.7 ) ; and TBUT at 2 and 4 weeks : ( at baseline = 5.5 2.9 ; 2 weeks = 6.9 5.0 ; 4 weeks = 7.4 5.5 ) .\
RESULTS	There was no significant change in MG secretion or TBUT in the control group .\
RESULTS	LipiFlow resulted in a greater significant reduction in dry eye symptoms than the iHeat WC .\
RESULTS	The crossover group demonstrated similar significant improvement 2 weeks post-treatment with the LipiFlow .\
RESULTS	There was no significant difference between groups in the incidence of non-serious , device-related adverse events .\
CONCLUSIONS	The LipiFlow System was significantly more effective than iHeat WC .\
CONCLUSIONS	These results support its safety and effectiveness in the treatment of MGD and dry eye symptoms .\
\
###20419973\
OBJECTIVE	To evaluate the effect of intralesional injection of verapamil in Peyronie 's plaque with confirmed lesion .\
METHODS	This randomized clinical trial was carried out between March 2005 and March 2006 on 16 patients with Peyronie 's disease who were referred to the Urology Clinic of Shohadaye Ashayer Hospital in Khorram Abad , Iran .\
METHODS	Performing a comprehensive physical exam , the genitalia of the patients were checked to confirm the diagnosis and reject other sexual disorders .\
METHODS	Besides , parameters such as penis curving , lesion size were measured .\
METHODS	Then , based on the 10-point visual analogue scale , sexual satisfaction of patients and their wives were recorded in a questionnaire .\
METHODS	Patients got intralesional verapamil every 14 days and were treated for 6 months .\
METHODS	After that , the parameters were assessed and data collected was analyzed using paired t-test .\
METHODS	P-value < 0.05 was considered statistically significant .\
RESULTS	On average , lesion size and penis curving decreased 30 % .\
RESULTS	Almost 20 % of patients and their wives were satisfied with the outcome of the treatment .\
RESULTS	No significant side effect was seen during the treatment .\
CONCLUSIONS	Injection of calcium channel blockers are effective for treatment of the Peyronie 's disease ; however , more studies with more patients are needed\
\
###16766587\
BACKGROUND	The aim of the study was to analyse the toxicity and health related quality of life ( HRQoL ) of breast cancer patients treated with FAC ( 5-fluorouracil , doxorubicin , cyclophosphamide ) and TAC ( docetaxel , doxorubicin , cyclophosphamide ) with and without primary prophylactic G-CSF ( PPG ) .\
METHODS	This was a phase III study to compare FAC and TAC as adjuvant treatment of high-risk node-negative breast cancer patients .\
METHODS	After the entry of the first 237 patients , the protocol was amended to include PPG in the TAC arm due to the high incidence of febrile neutropenia .\
METHODS	A total of 1047 evaluable patients from 49 centres in Spain , two in Poland and four in Germany were included in the trial .\
METHODS	Side-effects and the scores of the EORTC QLQ-C30 and QLQ BR-23 questionnaires were compared in the three groups ( FAC , TAC pre-amendment and TAC post-amendment ) .\
RESULTS	The addition of PPG to TAC significantly reduced the incidence of neutropenic fever , grade 2-4 anaemia , asthenia , anorexia , nail disorders , stomatitis , myalgia and dysgeusia .\
RESULTS	Patient QoL decreased during chemotherapy , more with TAC than FAC , but returned to baseline values afterwards .\
RESULTS	The addition of PPG to TAC significantly reduced the percentage of patients with clinically relevant Global Health Status deterioration ( 10 or more points over baseline value ) at the end of chemotherapy ( 64 % versus 46 % , P < 0.03 ) .\
CONCLUSIONS	The addition of PPG significantly reduces the incidence of neutropenic fever associated with TAC chemotherapy as well as that of some TAC-induced haematological and extrahaematological side-effects .\
CONCLUSIONS	The HRQoL of patients treated with TAC is worse than that of those treated with FAC but improves with the addition of PPG , particularly in the final part of chemotherapy treatment .\
\
###12187217\
OBJECTIVE	We designed an investigational study and placebo controlled trial to evaluate the efficacy of magnetic stimulation of the sacral roots for treating urinary frequency and urge incontinence .\
METHODS	A total of 48 women 43 to 75 years old ( mean age 61 ) with the complaint of urinary frequency and/or urge incontinence were studied .\
METHODS	We applied 15 Hz .\
METHODS	repetitive magnetic stimulation of the sacral roots with 50 % intensity output for 5 seconds per minute for 30 minutes .\
METHODS	Urodynamic investigations during magnetic stimulation were performed in 11 cases to evaluate acute effects for lowering urinary tract function .\
METHODS	Another 37 women were enrolled in a placebo controlled study to investigate short-term effects .\
METHODS	The mean number of voids daily , mean urine volume per void , number of leaks for 3 days and quality of life score were evaluated before and 1 week after stimulation .\
RESULTS	Urodynamic investigations revealed apparent elevation in mean maximum urethral closure pressure plus or minus standard deviation during stimulation in all 11 cases ( 8.4 + / - 3.6 cm .\
RESULTS	water , p = 0.00001 ) and a significant increase in mean bladder capacity after stimulation ( 58.2 + / - 50.2 ml. , p = 0.003 ) .\
RESULTS	In the placebo controlled study all parameters significantly improved in the active stimulation group .\
RESULTS	Intergroup comparison showed that mean urine volume per void , mean number of leaks and mean quality of life score improved more significantly in the active than in the sham stimulation group ( 23.5 + / - 25.6 ml .\
RESULTS	versus 6.2 + / - 22.5 , p = 0.04 , 3.6 + / - 4.1 versus 0.4 + / - 1.4 , p = 0.04 and 1.4 + / - 1.3 versus 0.4 + / - 0.8 , p = 0.01 , respectively ) .\
RESULTS	No adverse effects were noted in any patients .\
CONCLUSIONS	These results suggest that magnetic stimulation of the sacral roots may be useful for treating urinary frequency and urge incontinence .\
\
###19644398\
BACKGROUND	: New olive oil-based ( OL ) lipid emulsions ( olive : soy oil = 4:1 ) have lower polyunsaturated fatty acid ( PUFA ) ( 20 % vs 60 % ) and higher vitamin E content ( an antioxidant ) compared with traditional soybean oil ( SO ) emulsions .\
OBJECTIVE	: Compare efficacy and safety of OL with SO emulsions in preterm neonates ( < 28 weeks ) at high risk for oxidative stress .\
METHODS	: Preterm neonates ( gestation 23 - < 28 weeks ) were randomised to receive OL or SO emulsion for 5 days using a standard protocol in a tertiary perinatal centre ( King Edward Memorial Hospital for Women , Perth , Western Australia ) .\
METHODS	Investigators and outcome assessors were masked to allocation .\
METHODS	Plasma F2-isoprostanes ( lipid peroxidation marker ) , plasma , and red blood cell fatty acids were measured before and after the study .\
METHODS	Safety was monitored by liver function tests .\
RESULTS	: Forty-four of 50 participants ( OL-23 , SO-21 ) completed the study .\
RESULTS	Both emulsions were well tolerated with no significant adverse events .\
RESULTS	F2-isoprostane levels were comparable at baseline and study end .\
RESULTS	Oleic and linoleic acid levels were significantly high on day 6 in OL and SO groups , respectively .\
RESULTS	Long-chain PUFA levels were similar between groups despite the lower PUFA content of OL .\
RESULTS	The olive oil-based group had significantly higher levels of C18 :4 n-3 , suggesting Delta6-desaturase enzyme inhibition in the SO group .\
CONCLUSIONS	: Olive oil-based emulsion was safe and well tolerated by preterm neonates .\
CONCLUSIONS	Similar long-chain PUFA levels were achieved in the OL group despite significantly lower amount of PUFA content ; however , there was no difference in lipid peroxidation ( F2-isoprostane levels ) .\
CONCLUSIONS	Large trials are needed to confirm these benefits .\
\
###7760093\
OBJECTIVE	Our objective was to quantify the effects of intravenous anesthetics on values measured by or derived from transcranial Doppler sonography ( TCD ) during induction of general anesthesia .\
METHODS	We recorded blood flow velocity in the middle cerebral artery ( V-MCA ) before , during , and after induction of general anesthesia in six groups of young patients without intracranial pathology ( n = 10 each ) using TCD .\
METHODS	Patients were randomized to receive either 2 mg/kg propofol , 1.5 mg/kg methohexital , 5 mg/kg thiopental , 0.3 mg/kg etomidate , 2 micrograms/kg fentanyl and 0.15 mg/kg midazolam , or 1.5 mg/kg ketamine and 0.15 mg/kg midazolam intravenously .\
METHODS	At 2 min after injection , each patient was intubated and given isoflurane 0.8 % and nitrous oxide 66 % in oxygen .\
METHODS	Ventilation was set to achieve an end-tidal PCO2 of 40 mm Hg .\
METHODS	V-MCA , arterial blood pressure , heart rate , hematocrit , and PCO2 ( venous samples ) were measured before and 1 , 3 , 5 , 10 , and 30 min after induction of anesthesia .\
RESULTS	The preinduction data were not different between groups .\
RESULTS	At 1 min after injection , propofol , thiopental , methohexital , and etomidate significantly decreased V-MCA .\
RESULTS	TCD values were only slightly affected following fentanyl/midazolam .\
RESULTS	Ketamine/midazolam induced a modest rise in V-MCA .\
RESULTS	After endotracheal intubation , V-MCA increased in all groups , and slowly declined thereafter .\
CONCLUSIONS	Under the circumstances of our study , values derived from TCD measurements responded differently to the agents used to induce general anesthesia in nonneurosurgical patients .\
\
###11848258\
BACKGROUND	Epidemiological studies have shown that increased arterial stiffness and wave reflections , major determinants of systolic and pulse pressure , are associated with morbidity and mortality .\
BACKGROUND	Therapeutic trials based on cardiovascular mortality have recently shown that reduction of systolic blood pressure ( SBP ) requires normalization of both large-artery stiffness and wave reflections .\
OBJECTIVE	To compare the antihypertensive effects of the very-low-dose combination of perindopril ( 2 mg ) and indapamide ( 0.625 mg ) ( one or two tablets per day ) with the beta-blocking agent atenolol ( 50 mg ; one or two tablets per day ) in order to determine whether the combination decreased SBP and pulse pressure more than did atenolol , and whether this decrease occurred in relation to a reduction in arterial stiffness [ aortic pulse wave velocity ( PWV ) ] or a decrease in the intensity of , or delay in , wave reflections ( augmentation index , measured by applanation tonometry ) or a combination of both .\
METHODS	This was a double-blind randomized study in 471 individuals with essential hypertension followed for 12 months .\
METHODS	Arterial pressure was measured in the brachial artery ( mercury sphygmomanometer ) and in the carotid artery ( applanation tonometry ) .\
RESULTS	For the same reduction in diastolic blood pressure ( DBP ) , the combination of perindopril and indapamide decreased brachial SBP and pulse pressure significantly more than did atenolol ( adjusted differences between groups -6.2 + / - 1.5 and -5.5 + / - 1.0 mmHg , respectively ; P < 0.001 ) .\
RESULTS	This difference was even more pronounced for the carotid than for the brachial artery .\
RESULTS	Whereas both antihypertensive agents similarly decreased PWV , only the combination significantly attenuated wave reflections .\
CONCLUSIONS	Normalization of SBP , pulse pressure and arterial function -- a haemodynamic profile known to improve survival significantly in hypertensive populations at high cardiovascular risk -- was achieved to a greater extent with a very-low-dose combination of perindopril and indapamide than with atenolol .\
\
###19196110\
OBJECTIVE	We tested the hypothesis that LED phototherapy with combined 660-nm and 890-nm light will promote healing of venous ulcers that failed to respond to other forms of treatment .\
BACKGROUND	A variety of dressings , growth factors , and adjunct therapies are used to treat venous ulcers , but none seems to yield satisfactory results .\
METHODS	We used a randomized placebo-controlled double-blind study to compare a total of 20 patients divided with 32 chronic ulcers into three groups .\
METHODS	In group 1 the ulcers were cleaned , dressed with 1 % silver sulfadiazine ( SDZ ) cream , and treated with placebo phototherapy ( < .03 J/cm ( -3 ) ) using a Dynatron Solaris 705 phototherapy research device .\
METHODS	In group 2 the ulcers were treated similarly but received real phototherapy ( 3 J/cm ( -2 ) ) instead of placebo .\
METHODS	In group 3 ( controls ) , the ulcers were simply cleaned and dressed with SDZ without phototherapy .\
METHODS	The ulcers were evaluated with digital photography and computer image analysis over 90 d or until full healing was attained .\
RESULTS	Ulcers treated with phototherapy healed significantly faster than controls when compared at day 30 ( p + / - 0.01 ) , day 60 ( p + / - 0.05 ) , and day 90 ( p + / - 0.001 ) , and similarly healed faster than the placebo-treated ulcers at days 30 and 90 ( p + / - 0.01 ) , but not at day 60 .\
RESULTS	The beneficial effect of phototherapy was more pronounced when the confounding effect of small-sized ulcers was removed from the analysis .\
RESULTS	Medium - and large-sized ulcers healed significantly faster with treatment ( > or = 40 % rate of healing per month ) than placebo or control ulcers ( p + / - 0.05 ) .\
CONCLUSIONS	Phototherapy promotes healing of chronic venous ulcers , particularly large recalcitrant ulcers that do not respond to conventional treatment .\
\
###21518596\
BACKGROUND	American College of Cardiology/American Heart Association/European Society of Cardiology ( ACC/AHA/ESC ) guidelines gave fondaparinux a class I recommendation for use in patients with non-ST elevation acute coronary syndromes ( NSTE-ACS ) undergoing invasive or conservative strategy .\
BACKGROUND	Nadroparin is one of the common anticoagulants used in NSTE-ACS in China .\
BACKGROUND	Accordingly , this study compared the safety and efficacy between fondaparinux and nadroparin in patients with NSTE-ACS .\
METHODS	In this prospective , randomized , open-label , and single center study , a total of 300 patients with NSTE-ACS were randomized to receive either fondaparinux ( group F , n = 150 , 2.5 mg/d ) or nadroparin ( group N , n = 150 , 0.1 ml/10 kg q12 h ) for a mean of 4 days .\
METHODS	The primary safety endpoint was the incidence of major or minor bleeding at 9 days that was not related to coronary artery bypass grafting ( CABG ) .\
METHODS	The primary efficacy endpoints included death , myocardial infarction , or recurrent ischemia at 9 days .\
METHODS	All patients underwent a 180-day follow-up .\
RESULTS	Baseline characteristics were well matched between the two groups .\
RESULTS	There was a non-significant 28 % relative risk reduction in the primary safety endpoint in group F compared with group N ( 4.7 % vs. 6.7 % , HR 0.72 , 95 % CI 0.42-1 .65 , P = 0.38 ) .\
RESULTS	The primary efficacy endpoint was 8.0 % in group F and 10.0 % in group N ( HR , 0.82 , 95 % CI 0.54-1 .71 , P = 0.49 ) .\
RESULTS	The composite of the safety and efficacy endpoints at 9 days ( 10.0 % vs. 16.0 % , HR 0.61 , 95 % CI 0.31-1 .10 , P = 0.10 ) , 30 days ( 14.0 % vs. 17.9 % , HR 0.72 , 95 % CI 0.47-1 .16 , P = 0.21 ) , or 180 days ( 18.7 % vs. 27.3 % , HR 0.65 , 95 % CI 0.38-1 .11 , P = 0.11 ) showed a non-significant trend toward a lower value in group F.\
CONCLUSIONS	Fondaparinux resulted in a nonsignificant risk reduction in patients with NSTE-ACS in both bleeding and ischaemic events during short - and long-term follow-up compared with nadroparin .\
\
###19001830\
OBJECTIVE	Calcium-containing phosphate binders have been shown to increase the progression of vascular calcification in hemodialysis patients .\
OBJECTIVE	This is a prospective study that compares the effects of calcium acetate and sevelamer on coronary calcification ( CAC ) and bone histology .\
METHODS	101 hemodialysis patients were randomized for each phosphate binder and submitted to multislice coronary tomographies and bone biopsies at entry and 12 months .\
RESULTS	The 71 patients who concluded the study had similar baseline characteristics .\
RESULTS	On follow-up , the sevelamer group had higher levels of intact parathyroid hormone ( 498 + / - 352 vs. 326 + / - 236 pg/ml , p = 0.017 ) , bone alkaline phosphatase ( 38 + / - 24 vs. 28 + / - 15 U/l , p = 0.03 ) and deoxypyridinoline ( 135 + / - 107 vs. 89 + / - 71 nmol/l , p = 0.03 ) and lower LDL cholesterol ( 74 + / - 21 vs. 91 + / - 28 mg/dl , p = 0.015 ) .\
RESULTS	Phosphorus ( 5.8 + / - 1.0 vs. 6 + / - 1.0 mg/dl , p = 0.47 ) and calcium ( 1.27 + / - 0.07 vs. 1.23 + / - 0.08 mmol/l , p = 0.68 ) levels did not differ between groups .\
RESULTS	CAC progression ( 35 vs. 24 % , p = 0.94 ) and bone histological diagnosis at baseline and 12 months were similar in both groups .\
RESULTS	Patients of the sevelamer group with a high turnover at baseline had an increase in bone resorption ( eroded surface , ES/BS = 9.0 + / - 5.9 vs. 13.1 + / - 9.5 % , p = 0.05 ) , whereas patients of both groups with low turnover at baseline had an improvement in bone formation rate ( BFR/BS = 0.015 + / - 0.016 vs. 0.062 + / - 0.078 , p = 0.003 for calcium and 0.017 + / - 0.016 vs. 0.071 + / - 0.084 microm ( 3 ) / microm ( 2 ) / day , p = 0.010 for sevelamer ) .\
CONCLUSIONS	There was no difference in CAC progression or changes in bone remodeling between the calcium and the sevelamer groups .\
\
###20060945\
BACKGROUND	An effective vaccine would be a significant progress in the management of chronic HCV infections .\
BACKGROUND	This study was designed to examine whether different application schedules and injection routes may enhance the immunogenicity of the HCV peptide vaccine IC41 .\
METHODS	In this randomized trial 54 healthy subjects received either subcutaneous ( s.c. ) or intradermal ( i.d. ) vaccinations weekly ( 16 injections ) or every other week ( 8 injections ) .\
METHODS	One group additionally received imiquimod , an activator of the toll-like receptor ( TLR ) 7 .\
METHODS	The T cell epitope-specific immune response to IC41 was assessed using [ ( 3 ) H ] - thymidine CD4 + T cell proliferation , interferon-gamma ( IFN-gamma ) CD8 + and CD4 + ELIspot and HLA-A * 0201 fluorescence-activated cell sorting ( FACS ) tetramer-binding assays .\
RESULTS	More than 60 % of vaccinees responded in the CD4 + T cell proliferation assay in all groups .\
RESULTS	An HLA-A * 0201 FACS tetramer-binding assay and IFN-gamma CD8 + ELIspot class I response of more than 70 % was induced in four and three groups , respectively .\
RESULTS	IC41 induced significant immunological responses in all groups with responder rates of up to 100 % .\
RESULTS	Interestingly , topical imiquimod was not able to enhance immunogenicity but was associated with a lower immune response .\
RESULTS	Local injection site reactions were mostly transient .\
RESULTS	Intradermal injections caused more pronounced reactions compared to s.c. , especially erythema and edema .\
CONCLUSIONS	Compared to a previous study intensified dosing and/or i.d. injections enhanced the response rates to the vaccine IC41 in three assays measuring T cell function .\
CONCLUSIONS	Immunization with IC41 was generally safe in this study .\
CONCLUSIONS	These results justify testing IC41 in further clinical trials with HCV-infected individuals .\
\
###11477810\
OBJECTIVE	To observe clinical effects of Zhiling Decoction ( ZLD ) in treating senile vascular dementia .\
METHODS	Seventy-eight patients were randomly divided into treated group and control group .\
METHODS	In treated group which was treated with ZLD , a self-formulated proved recipe .\
METHODS	In control group , which was administered with Naofukang ( [ symbol : see text ] ) .\
RESULTS	ZLD could decrease the level of serum cholesterol , serum triglyceride and plasma LPO significantly ; increase the level of high density lipoprotein ( HDL ) and SOD in red blood cells ; dilate cerebral vessels , increase cerebral blood flow .\
RESULTS	As for P300 , an index to reflect intelligence , the latency of P3 was shorter and the amplitude was raised , the brain electrical activity monitoring ( BEAM ) was improved remarkably , the revised Nagayakawa dementia scale scoring ( NDS ) of patients promoted , clinical symptom was improved significantly .\
RESULTS	Total effective rate in clinical practice reached 87 % .\
CONCLUSIONS	ZLD had good effects on senile vascular dementia indeed .\
\
###25552940\
OBJECTIVE	The research tested the accuracy of the VIVO Harvester software in identifying publications authored by faculty members affiliated with a National Institutes of Health Clinical and Translational Sciences Award ( CTSA ) site .\
METHODS	Health sciences librarians created `` gold standard '' lists of references for the years 2001 to 2011 from PubMed for twenty-five randomly selected investigators from one CTSA site .\
METHODS	These gold standard lists were compared to the same twenty-five investigators ' reference lists produced by VIVO Harvester .\
METHODS	The authors subjected the discrepancies between the lists to sensitivity and specificity analyses .\
RESULTS	The VIVO Harvester correctly identified only about 65 % of the total eligible PubMed references for the years 2001-2011 for the CTSA-affiliated investigators .\
RESULTS	The identified references produced by VIVO Harvester were precise yet incomplete .\
RESULTS	The sensitivity rate was 0.65 , and the specificity rate was 1.00 .\
CONCLUSIONS	While the references produced by VIVO Harvester could be confirmed in PubMed , the VIVO Harvester retrieved only two-thirds of the required references from PubMed .\
CONCLUSIONS	National Institutes of Health CTSA sites will need to supplement VIVO Harvester-produced references with the expert searching skills of health sciences librarians .\
CONCLUSIONS	Health sciences librarians with searching skills need to alert their CTSA sites about these deficiencies and offer their skills to advance their sites ' missions .\
\
###17328809\
BACKGROUND	Different interventions can reduce the burden of the chronic low back pain .\
BACKGROUND	One example is the use of a ` Back School Programme ' .\
BACKGROUND	This is a brief therapy that uses a health education method to empower participants through a procedure of assessment , education and skill development .\
BACKGROUND	This study aimed to evaluate to what extent the programme could improve quality of life in those who suffer from the condition .\
METHODS	This was a randomized controlled trial .\
METHODS	One-hundred and two female patients with low back pain ( n = 102 ) were randomly allocated into two groups , matched in terms of age , weight , education , socioeconomic status , occupation and some aspects of risk behavior .\
METHODS	Group 1 ( back school group , n = 50 ) but not group 2 ( clinic group , n = 52 ) received the ` Back School Programme ' .\
METHODS	Then quality of life using the Short Form Health Survey ( SF-36 ) was assessed at two time points : at baseline and at three months follow-up .\
METHODS	The findings were compared both within and between two groups .\
RESULTS	The ` Back School Programme ' was effective in improving patients ' quality of life ; significant differences were found on all eight subscales of the SF-36 for group 1 .\
RESULTS	In the clinic group ( group 2 ) , improvement was observed on three scales ( bodily pain , vitality and mental health ) but these improvements were less than in group 1 .\
RESULTS	The mean improvement over all eight subscales of the SF-36 was significantly better for the ` Back School Programme ' group .\
CONCLUSIONS	The ` Back School Programme ' is an effective intervention and might improve the quality of life over a period of 3 months in patients who experience chronic low back pain .\
\
###22172923\
OBJECTIVE	To compare the efficacy of low-frequency low-intensity electrotherapy and manual lymphatic drainage in the treatment of chronic upper limb breast cancer-related lymphoedema .\
METHODS	Cross-over single-blind random clinical trial .\
METHODS	Rehabilitation service .\
METHODS	Thirty-six women with chronic upper limb breast cancer-related lymphoedema .\
METHODS	Patients were randomized to undergo 10 sessions of manual lymphatic drainage followed by 10 sessions of low-frequency low-intensity electrotherapy or to undergo first low-frequency low-intensity electrotherapy followed by manual lymphatic drainage .\
METHODS	There was a month of washout time between treatments .\
METHODS	Each patient was examined just before and after each treatment .\
METHODS	Researchers and outcome assessors were blinded for assigned treatment .\
METHODS	Outcomes were lymphoedema volume , pain , heaviness and tightness , and health-related quality of life measured with the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer version 4 ( FACT-B +4 ) .\
METHODS	Carry-over , period and treatment effects were analysed .\
METHODS	Treatment effect was assessed using paired t-test .\
RESULTS	Thirty patients finalized treatment .\
RESULTS	Comparing the changes in low-frequency low-intensity electrotherapy with manual lymphatic drainage changes , there were no significant differences .\
RESULTS	Low-frequency low-intensity electrotherapy did not reduce lymphoedema volume ( mean of change = 19.77 mL , P = 0.36 ) , but significant reductions were observed in pain , heaviness and tightness ( mean of change = 13.1 , 16.2 and 6.4 mm , respectively ) , and FACT-B +4 summaries improved significantly ( Trial Outcome Index mean of change = 5.4 , P = 0.015 ) .\
RESULTS	Manual lymphatic drainage showed no significant changes in any of the outcomes\
CONCLUSIONS	Although there are no significant differences between treatment changes , the observed trend towards a better health-related quality of life is remarkable in low-frequency low-intensity electrotherapy .\
\
###24261013\
OBJECTIVE	The purpose of this study was to examine the relative effectiveness of 2 forms of physical education instruction on students ' skill and technical performance , as well as content knowledge in 3 track and field events .\
METHODS	Students from 6 classes in 3 Portuguese schools completed 900-min units conducted under the auspices of sport education or a more traditional teacher-directed format .\
METHODS	Classes were randomly assigned to these conditions within each school .\
RESULTS	Although both groups improved significantly from pretest to posttest , the sport education classes outperformed the traditional classes in both technique and skill execution .\
RESULTS	Only the sport education group made significant improvements in content knowledge .\
RESULTS	When the students in the traditional group were tested at the point in time where they would usually complete a unit of physical education ( 450 min ) , there were no significant improvements in any of the study 's variables .\
CONCLUSIONS	The explanation given for the superior performance outcomes of the sport education classes lies in the nature of formal competition and team affiliation , which are cornerstones of this pedagogical model .\
CONCLUSIONS	That is , students take their learning experiences more seriously than in traditional and often inauthentic classes .\
CONCLUSIONS	In terms of content knowledge , the fact that sport education has a level of content-embedded accountability that holds students accountable for their officiating duties is postulated as a significant contributor to their increased understanding of rules and protocols of athletic events .\
\
###8988699\
OBJECTIVE	To assess the effects of medroxyprogesterone acetate on bone density in women who have had a hysterectomy .\
METHODS	Randomised , double-blind , placebo-controlled trial of medroxyprogesterone acetate 10 mg , 20 mg or placebo as an adjunct to oestrogen therapy .\
METHODS	One hundred and twenty-three women , aged 18 to 45 years and currently receiving daily oestrogen , who presented at a university-based rheumatology practice .\
METHODS	The women were randomly assigned to receive either medroxyprogesterone acetate 10 mg , 20 mg or placebo daily beginning on day 15 of each month for one year .\
METHODS	Forty-one women were randomised into each group .\
METHODS	The primary outcome measurement was the percentage of change from baseline in bone mineral density of the lumbar spine ( L2-L4 ) .\
METHODS	Secondary outcome measures included differences in femoral neck bone density , cholesterol and triglyceride levels between groups .\
RESULTS	At one year , change in bone mineral density did not differ between either the treatment or placebo groups .\
RESULTS	Medroxyprogesterone acetate 20 mg and 10 mg led to statistically significant reductions in very low density lipoprotein cholesterol , total triglycerides , and very low density lipoprotein triglycerides when compared with placebo .\
RESULTS	Medroxyprogesterone acetate 20 mg also led to a statistically significant reduction in high density lipoprotein cholesterol , high density lipoprotein-2 cholesterol , and high density lipoprotein-2 triglycerides .\
CONCLUSIONS	Medroxyprogesterone acetate at either dose as an adjunct to oestrogen did not improve bone mineral density at one year when compared with placebo .\
CONCLUSIONS	Medroxyprogesterone acetate 10 mg may not adversely affect lipids .\
CONCLUSIONS	Medroxyprogesterone acetate 20 mg , however , did reduce high density lipoprotein cholesterol and therefore may increase cardiovascular risk .\
\
###17599307\
BACKGROUND	Melioidosis is a tropical infectious disease associated with significant mortality .\
BACKGROUND	Most deaths occur early and are caused by fulminant sepsis .\
METHODS	In this randomized , placebo-controlled trial , we assessed the efficacy of lenograstim ( granulocyte colony-stimulating factor [ G-CSF ] , 263 mu g per day administered intravenously ) in ceftazidime-treated patients with severe sepsis caused by suspected melioidosis in Thailand .\
RESULTS	Over a 27-month period , 60 patients were enrolled to receive either G-CSF ( 30 patients , 18 of whom had culture-confirmed melioidosis ) or placebo ( 30 patients , 23 of whom had culture-confirmed melioidosis ) .\
RESULTS	Mortality rates were similar in both groups ( G-CSF group , 70 % ; placebo group , 87 % ; risk ratio , 0.81 ; 95 % confidence interval , 0.61-1 .06 ; P = .2 ) , including among patients with confirmed melioidosis ( 83 % vs. 96 % ; P = .3 ) .\
RESULTS	The duration of survival was longer for patients who received G-CSF than for patients who received placebo ( 33 h vs. 18.6 h ; hazard ratio , 0.56 ; 95 % confidence interval , 0.31-1 .00 ; P = .05 ) .\
CONCLUSIONS	Receipt of G-CSF is associated with a longer duration of survival but is not associated with a mortality benefit in patients with severe sepsis who are suspected of having melioidosis in Thailand .\
CONCLUSIONS	We hypothesize that G-CSF may `` buy time '' for severely septic patients , but survival is more likely to be improved by management of associated metabolic abnormalities and organ dysfunction associated with severe sepsis .\
\
###8082533\
OBJECTIVE	This study was designed to determine if food-containing hypocaloric diets are as effective as liquid-supplement diets in promoting weight loss for obese individuals with non-insulin-dependent diabetes mellitus ( NIDDM ) .\
METHODS	Forty NIDDM subjects with body mass indexes ( BMIs ) of 30-40 kg/m2 were randomized to one of two 800-kcal diets for 12 weeks .\
METHODS	Group A received liquid supplement only , and group B received supplement plus an evening meal .\
METHODS	Both groups received an intensive behavioral education program .\
RESULTS	Weight loss and improvements in glycemic , blood lipid , and blood pressure parameters were similar for the two groups .\
RESULTS	Weight loss averaged 15.7 kg for the entire group .\
RESULTS	The need for insulin , anti-diabetes , and anti-hypertensive medication decreased significantly .\
RESULTS	No serious side effects were observed .\
CONCLUSIONS	Both food-containing and supplement diets providing 800 kcal a day effectively promote weight loss for obese individuals with NIDDM .\
\
###20813685\
OBJECTIVE	To compare the effect and hemodynamics of sevoflurane ( SEV ) and propofol ( PRO ) in combined anesthesia induction with remifentanil for tracheal intubation fibreoptic bronchoscope ( FOB ) .\
METHODS	Twenty-four patients without difficult airway undergoing elective surgery with tracheal intubation general anesthesia were randomly divided into SEV and PRO group .\
METHODS	FOB intubation was performed with sevoflurane or propofol administration combined with remifentanil induction .\
METHODS	Blood pressure ( BP ) , heart rate ( HR ) , SPO2 and Narcotrend index ( NI ) were monitored to evaluate the anesthetic depth during the induction .\
METHODS	The time to loss of consciousness ( LOC ) , intubation time , intubation score , anesthetic dosage and adverse effects were recorded .\
RESULTS	No significant difference was found between the two groups in the time to LOC , intubation time , intubation score , remifentanil dosage .\
RESULTS	Intubation was performed successfully in both groups .\
RESULTS	BP and HR of both groups decreased after the induction and did not increase after the intubation , with variation within the normal range .\
RESULTS	No significant difference in BP and HR was found between the two groups .\
RESULTS	NI of both groups decreased after the induction and during intubation .\
RESULTS	NI of SEV group 2 min after intubation was higher than that of PRO group .\
RESULTS	There was no significant difference in NI between the two groups at the other time points .\
RESULTS	No significant adverse effects or recall of the intubation procedure were reported .\
CONCLUSIONS	Anesthesia induction FOB intubation with sevoflurane and propofol , both in combination with remifentanil , can be applied in surgical patients without contraindications to general anesthesia , and both methods can provide fast induction and good intubation condition with stable hemodynamics .\
\
###12595976\
OBJECTIVE	In a previous non-randomized study , we demonstrated that no difference occurred in the rate of acquisition of bacteriuria between a complex closed drainage system ( CCDS ) and a two-chamber drainage system ( TCDS ) in patients in an intensive care unit ( ICU ) .\
OBJECTIVE	To confirm this result , we performed a randomized , prospective , and powerful study assessing the effectiveness of the CCDS and the TCDS in ICU patients .\
METHODS	Randomized , prospective , and controlled study .\
METHODS	Medico-surgical intensive care unit ( 16 beds ) in a teaching hospital .\
METHODS	Three hundred and eleven patients requiring an indwelling urinary catheter for longer than 48 h were assigned individuals to the TCDS group or CCDS group to compare the rate of acquisition of bacteriuria .\
RESULTS	Patients did not receive prophylactic antibiotics during placement management or catheter withdrawal .\
RESULTS	Urine samples were obtained weekly for the duration of catheterization and within 24 h after catheter removal , and each time symptoms of urinary infection were suspected .\
RESULTS	There was no statistical difference in the rate of bacteriuria between the two groups .\
RESULTS	Bacteriuria occurred in 8 % and 8.5 % of patients for TCDS and CCDS , respectively .\
RESULTS	Rates of urinary tract infection were 12.1 and 12.8 episodes per 1,000 days of catheter .\
CONCLUSIONS	This randomized study , that compares the effectiveness of a TCDS and a CCDS in ICU patients , confirms the results of our previous study .\
CONCLUSIONS	No differences were noted between the two systems ( a = 0.05 ) .\
CONCLUSIONS	The higher cost of CCDS is not justified for ICU patients .\
\
###9590863\
OBJECTIVE	To observe the early intraocular pressure ( IOP ) after extracapsular cataract extraction ( ECCE ) .\
METHODS	ECCE was performed on 58 eyes which were randomly divided into 3 groups , and postoperatively , at various intervals the IOP was measured and compared .\
RESULTS	The low IOP was not measurable by tonometer at 1 hour after the operation .\
RESULTS	At postoperative 3 hours , the mean IOP was higher than that of the preoperative level .\
RESULTS	The peak of IOP elevation was between postoperative 6-12 hours , over 2.80 kPa ( 1 kPa = 7.5 mmHg ) and > or = 4.0 kPa were in 31 eyes ( 53.45 % ) and 4 eyes ( 6.90 % ) respectively , and the highest IOP was 4.40 kPa .\
RESULTS	Naturally , the levels of IOP resumed normal in all cases in postoperative 24 hours .\
RESULTS	The IOPs in 5 eyes ( 8.62 % ) were lower than the normal level ( < 1.33 kPa ) within 72 hours after the operation .\
RESULTS	The postoperative IOP of the group with diamox administered preoperatively was lower than that of the group with either mannitol or without drugs ( P < 0.05 ) to lower the IOP preoperatively .\
RESULTS	The eyes with normal postoperative IOP accounted for the majority .\
CONCLUSIONS	Preoperative oral administration of diamox is a measure to prevent the early elevation of IOP after ECCE .\
\
###23453439\
OBJECTIVE	Chronic kidney disease ( CKD ) is associated with worse outcomes in patients with coronary artery disease ( CAD ) .\
OBJECTIVE	How CKD influences the benefit-risk balance of drug-eluting stents ( DES ) versus bare-metal stents ( BMS ) is less known .\
RESULTS	In the multicentre BASKET-PROVE trial , 2314 patients in need of large coronary stenting ( 3.0 mm ) were randomised 2:1 to DES or BMS .\
RESULTS	In an a priori planned secondary analysis , outcomes were evaluated according to renal function defined by estimated glomerular filtration rates ( eGFR ; normal : eGFR 60 ml/min/1 .73 m ( 2 ) ; CKD : eGFR < 60 ml/min/1 .73 m ( 2 ) ) .\
RESULTS	The primary endpoint was the first major adverse cardiac event ( MACE : cardiac death , myocardial infarction , target vessel revascularisation ) up to 2 years .\
RESULTS	A Cox proportional-hazard model was used to evaluate adjusted relative risks ( hazard rates , HRs ) for BMS versus DES .\
RESULTS	The interaction of stent type and renal function was tested .\
RESULTS	CKD patients ( 189 ( 11.2 % ) / 1681 with such data ) had a 2-year MACE rate of 8.5 % versus 7.4 % in those without CKD [ HR 0.98 ( 0.56-1 .72 ) , p = 0.95 ] with cardiac mortalities of 5.3 % and 1.5 % , respectively ( p = 0.002 , non-significant after baseline adjustments ) .\
RESULTS	The MACE rate was lower in CKD patients with DES than with BMS [ 4.9 % versus 15.2 % , p = 0.017 , HR 0.29 ( 0.10-0 .80 ) ] as was the MACE rate in patients without CKD [ 5.6 % with DES versus 11.1 % with BMS , p < 0.0001 , HR 0.51 ( 0.35-0 .75 ) ] .\
RESULTS	No significant interaction between stent type and renal function was found .\
CONCLUSIONS	This analysis of patients needing large coronary artery stenting confirms the increased mortality of CKD patients and documents a long-term benefit of DES compared to BMS irrespective of kidney function .\
\
###19330801\
BACKGROUND	Recent research has shown that even small doses ( < 40mg ) of caffeine can improve alertness and increase performance efficiency on attention tasks .\
BACKGROUND	Previous studies have given the caffeine in a variety of beverages or in capsules and it was of interest to see whether similar effects could be observed when the caffeine was given in gum .\
BACKGROUND	In addition , chewing gum has been shown to have behavioural effects and the present study extended our knowledge of this topic .\
OBJECTIVE	To compare the effects of caffeinated gum ( 40 mg ) , placebo gum and no gum conditions on mood and attention .\
METHODS	A double blind placebo controlled study was conducted with volunteers being randomly assigned to one of the three conditions .\
METHODS	Baseline measures of mood and attention were taken prior to chewing and a test session was then conducted .\
METHODS	One hundred and eighteen young adults participated in the study .\
RESULTS	Caffeinated gum was associated with a more positive mood and better performance on tasks requiring sustained attention .\
RESULTS	The caffeine improved the speed of encoding of new information which is consistent with previous findings .\
RESULTS	Chewing placebo gum was also found to be associated with more positive mood , both shortly after chewing and at the end of the study .\
CONCLUSIONS	The implications of the present study are that chewing caffeinated gum has been shown to improve performance efficiency and mood by its alerting and energising effects .\
CONCLUSIONS	The profile of caffeine effects is what one would predict from the existing caffeine literature and such effects may be extremely beneficial in real-life situations .\
CONCLUSIONS	Prior chewing of placebo gum was associated with a more positive mood and this also confirms previous findings .\
\
###25899986\
BACKGROUND	The BELOB study , a randomised controlled phase 2 trial comparing lomustine , bevacizumab and combined lomustine and bevacizumab in patients with recurrent glioblastoma , showed that the 9-month overall survival rate was most promising in the combination arm .\
BACKGROUND	Here we report the health-related quality of life ( HRQoL ) results , a secondary trial end-point .\
METHODS	HRQoL was measured at baseline and every 6weeks until progression using the European Organisation for Research and Treatment of Cancer ( EORTC ) core questionnaire ( QLQ-C30 ) and brain module ( QLQ-BN20 ) .\
METHODS	HRQoL was assessed over time for five preselected scales ( global health ( GH ) , physical ( PF ) and social functioning ( SF ) , motor dysfunction ( MD ) and communication deficit ( CD ) ) .\
METHODS	Moreover , mean changes in HRQoL from baseline until progression were determined .\
RESULTS	138/148 patients with at least a baseline HRQoL assessment were analysed .\
RESULTS	Over time , HRQoL remained relatively stable in all treatment arms for all five scales , at least during the first three treatment cycles .\
RESULTS	More than half ( 54-61 % ) of the patients showed stable ( < 10 point change ) or improved ( 10 point change ) HRQoL during their progression-free time , except for SF ( 43 % ) , irrespective of treatment arm .\
RESULTS	Deterioration of mean HRQoL was most profound at disease progression for all scales except SF , which deteriorated earlier in disease course .\
RESULTS	Compared to baseline , 40 % of patients had clinically relevant ( 10 points ) worse GH , PF and SF , while 44 % and 31 % had increased MD and CD at disease progression , irrespective of treatment arm .\
CONCLUSIONS	Bevacizumab , whether or not in combination with lomustine , did not negatively affect HRQoL in patients treated for recurrent glioblastoma in this randomised study .\
\
###17440528\
BACKGROUND	Familial hypercholesterolemia ( FH ) is associated with a high risk of coronary heart disease .\
BACKGROUND	Pharmacological treatment and diet are both essential for the management of FH .\
BACKGROUND	Foods rich in plant sterols ( PS ) may play an important role in the treatment of patients with these disorders .\
OBJECTIVE	To test the effect of the intake of PS on low-density lipoprotein ( LDL ) concentration , endothelial function ( EF ) and LDL particle size in 30 patients with FH .\
METHODS	Randomized and crossover dietary intervention study .\
METHODS	Tertiary outpatient care .\
METHODS	Thirty-eight were recruited , but only 30 were subjected to four low-fat dietary intervention periods , each of 4 weeks .\
METHODS	Each intervention had a different content of cholesterol ( < 150 or 300 mg/day ) and sitosterol ( < 1 or 2 g/day ) .\
METHODS	Lipid response , EF and LDL particle size were analysed after the intervention .\
RESULTS	Plasma sitosterol/cholesterol ratio was higher during both plant sterol-rich periods than during the low plant sterols periods .\
RESULTS	Basal sitosterol concentrations predicted the LDL-cholesterol response during the intake of plant sterol-enriched diets .\
RESULTS	The change in LDL-cholesterol was significantly greater in subjects in the upper and intermediate tertiles of basal plasma sitosterol concentrations ( -21 + / -8 mg/dl , P = 0.03 ; -19 + / -7 mg/dl , P = 0.04 , respectively ) than in subjects in the lower tertile ( 8 + / -5 mg/dl ) when they changed from a low cholesterol diet to a low cholesterol plus plant sterol diet .\
CONCLUSIONS	Our study demonstrates that basal sitosterol values can predict hypolipidemic response in patients with FH .\
\
###19378437\
OBJECTIVE	To investigate the impact of testosterone supplementation on postprandial triglycerides in elderly men with subnormal endogenous testosterone .\
METHODS	Twenty-six men with subnormal testosterone levels ( < or = 11.0 nmol/L ) were randomly assigned to treatment with intramuscular testosterone or placebo for one year in a double-blinded study .\
METHODS	The participants underwent an oral fat load before and after the treatment period , and serum and chylomicron triglyceride levels were measured fasting and 2 , 4 , 6 and 8 h afterwards , together with total fat mass and fat-free mass .\
RESULTS	Total testosterone rose to low-normal levels in the testosterone-treated group .\
RESULTS	No differences in waist circumference , body mass index , serum levels of total cholesterol , low-density lipoprotein cholesterol , high density lipoprotein cholesterol , fasting triglyceride concentrations or lipase activity between the groups were observed during testosterone treatment .\
RESULTS	Testosterone treatment did not affect postprandial serum and chylomicron triglyceride levels assessed by area under the curve , incremental area under the curve or triglyceride response .\
RESULTS	Total fat mass was significantly reduced ( p < 0.001 ) while fat-free mass was significantly increased ( p < 0.001 ) in the testosterone-treated group .\
CONCLUSIONS	Normalizing testosterone levels in elderly men does not seem to affect the postprandial lipid metabolism to any great extent , but has favourable effects on body composition .\
\
###22057385\
OBJECTIVE	The anatomical landmark for the anteroposterior ( AP ) axis of the proximal tibia and its variability was investigated in order to determine whether a certain landmark could be employed as a reference axis for the proximal tibia after the rotating platform mobile bearing and fixed bearing total knee arthroplasties ( TKAs ) .\
METHODS	Eighty primary osteoarthritic knees were randomized to undergo either rotating platform mobile bearing ( Group A , n = 40 ) or fixed bearing ( Group B , n = 40 ) TKAs , and were followed up for 31 and 30 months , respectively .\
METHODS	The AP axes were defined for the distal femur , proximal tibia , ankle , and each TKA component on the reconstructed CT scan and the angles between the distal femoral AP axis and those of each bone or component were estimated .\
METHODS	Clinical and radiographic outcomes were evaluated during the follow up .\
RESULTS	A significant difference was seen between the preoperative and postoperative rotational position of the proximal tibia relative to the distal femur following rotating platform mobile bearing TKA ( P = 0.014 ) whereas no such difference was seen after fixed bearing TKA .\
RESULTS	The mean postoperative alignment of the tibia differed between the two groups ( Group A : Group B = -2.9:0.2 , P = 0.010 ) and its variability was significantly greater in group A ( P < 0.001 ) .\
RESULTS	There were no differences in the clinical outcomes including range of motion , knee society score , function score , HSS , and WOMAC score as well as the mean postoperative coronal tibiofemoral alignment between the two groups .\
CONCLUSIONS	The unpredictable change in the rotational axis of the tibia and its broad variability after rotating platform mobile bearing TKA may provide a warning against the use of a fixed landmark for establishing tibial rotational alignment .\
\
###19526757\
OBJECTIVE	To investigate the therapeutic effects of an early application of Chaiqin Chengqi Decoction ( CQCQD ) on severe acute pancreatitis ( SAP ) complicated with acute respiratory distress syndrome ( ARDS ) .\
METHODS	Forty patients of SAP-ARDS were equally randomized into the early-treated group ( ET ) and the late-treated group ( LT ) , CQCQD was administered to them immediately and 3 days later after hospitalization respectively .\
METHODS	Baseline materials in the two groups at the entry were insignificantly different ( P > 0.05 ) , and the same conventional Western medical therapy were available to them all .\
METHODS	The Acute Physiology and Chronic Heath Evaluation II ( APACHE I ) scores , the incidence and sustained time of complications , the occurrence of infection , requirement of operation shifting on day 7 , as well as the duration resided in hospital and mortality in patients were observed and compared .\
RESULTS	Comparisons of the above-mentioned clinical indexes between groups showed that the APACHE II score was lower ( 5.1 + / - 2.0 scores vs 9.3 + / - 4.3 scores , P < 0.01 ) ; the incidence of shock was lesser ( 1/20 vs 7/19 ) ; the duration of ARDS , renal failure , cardiac insufficiency , hepatic dysfunction , cerebropathy and enteroplegia , as well as the duration in hospital and the requirement of operation shifting were all shorter significantly ( P < 0.05 ) in the ET group than those in the LT group , but no statistical difference ( P > 0.05 ) was shown in terms of the infection incidence and the mortality .\
CONCLUSIONS	An early application of CQCQD in the treatment of SAP could shorten the duration of complications and the couse of disease , lower the requirement of operation shifting .\
CONCLUSIONS	But further study with large samples for explore its impact on the infection incidence and the mortality is needed .\
\
###22281018\
BACKGROUND	Anastrozole is an aromatase inhibitor used to treat advanced breast cancer in postmenopausal women .\
BACKGROUND	A generic 1-mg tablet of anastrozole was recently developed .\
OBJECTIVE	The study was designed to provide data to submit to Korean regulatory authorities to allow marketing of the test formulation .\
OBJECTIVE	We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy male adult volunteers .\
METHODS	This single-dose , randomized , double-blind , 2-way crossover trial was conducted in the Clinical Trial Center at the Asan Medical Center ( Seoul , Korea ) .\
METHODS	A total of 24 healthy male Korean volunteers were enrolled .\
METHODS	Subjects were randomized to receive 1 mg of the test or reference formulation , and pharmacokinetic ( PK ) parameters were measured .\
METHODS	After a 3-week washout period , the other formulation was administered , and PK parameters were measured again .\
METHODS	C ( max ) and AUC ( last ) were determined from blood samples obtained at 0.33 , 0.67 , 1 , 1.5 , 2 , 3 , 4 , 6 , 8 , 12 , 24 , 48 , 72 , 96 , 120 , 168 , and 216 hours after drug administration .\
METHODS	The formulations were considered bioequivalent if the 90 % CIs of the geometric mean ratios of test-to-reference formulations for AUC ( last ) and C ( max ) were within the bioequivalence limits of 0.8 to 1.25 .\
METHODS	Nonlinear mixed-effect modeling and Monte Carlo simulations for both formulations were also conducted , and the results were used to characterize and compare the PK properties .\
METHODS	Safety profile and tolerability were assessed using measurements of vital signs , clinical chemistry tests , and interviews .\
RESULTS	All enrolled subjects completed the study .\
RESULTS	A total of 8 adverse events ( AEs ) were reported ( 2 on test formulation , 6 on reference formulation ) in 7 of 24 participants .\
RESULTS	These AEs were headache ( n = 1 ) , hordeolum ( n = 1 ) , and abnormal laboratory test values ( n = 6 ) .\
RESULTS	Both formulations were well tolerated , and there were no serious AEs .\
RESULTS	Both formulations were best described by a 2-compartment disposition model with lag phase .\
RESULTS	The 90 % CIs of the geometric mean ratios of test formulation to reference formulation were 0.96 to 1.08 for C ( max ) and 0.93 to 1.0 for AUC ( last ) .\
CONCLUSIONS	The test and reference formulations had similar PK parameters and similar plasma concentration-time profiles .\
CONCLUSIONS	The test formulation of anastrozole met the Korean regulatory criteria ( AUC and C ( max ) ) for assuming bioequivalence .\
CONCLUSIONS	ClinicalTrials.gov identifier : NCT01105299 .\
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###8593380\
OBJECTIVE	To evaluate the relationship between vitamin A supplementation , plasma retinol level ( PRL ) and incidence , severity and duration of acute respiratory infect ions ( ARI ) in children 1-5 years old .\
METHODS	A one year prospective randomized intervention study from June 1989 to May 1990 in Cikutra , a suburb of Bandung , Indonesia .\
METHODS	Out of almost 2000 children aged 12-54 months , 269 were selected by stratified randomization .\
METHODS	Vitamin A ( 200,000 IU orally ) was administered at 6-monthly intervals in a double blind , placebo controlled programme .\
METHODS	Every 2 weeks , primary health care workers collected data on respiratory symptoms in the children , and every month a pediatrician examined the children .\
METHODS	Venous blood samples were obtained at the start and at 3 and 6 months for plasma retinol levels ( PRL ) .\
RESULTS	The mean PRL at the start of the study was 20 + / - 8 micrograms/dl ; 8 % of the children showed a deficient level of less than 10 micrograms/dl .\
RESULTS	The incidence or ARI was 6.7 + / - 3.5 episodes per child per year with a mean duration of 5.3 + / - 3.1 days per episode .\
RESULTS	In vitamin A supplemented children the duration of ARI was slightly shorter ( 5.2 + / - 3.1 versus 5.6 + / - 3.1 days , P < 0.01 ) but no effect on the incidence or severity of ARI was detected .\
RESULTS	Low , and especially deficient , PRL had improved after 3 months and even after 6 months , but this was unrelated to vitamin A supplementation .\
RESULTS	There was also no relationship between PRL and incidence , severity or duration of ARI .\
CONCLUSIONS	Only a slight relationship is found between vitamin A supplementation and ARI duration in under-fives .\
\
###17959975\
BACKGROUND	Prewarming and intraoperative warming with forced air-warming systems prevent perioperative hypothermia and shivering in patients undergoing elective cesarean delivery with epidural anesthesia .\
BACKGROUND	We tested the hypothesis that intraoperative lower body forced air-warming prevents hypothermia in patients undergoing elective cesarean delivery with spinal anesthesia .\
METHODS	Thirty healthy patients undergoing cesarean delivery with spinal anesthesia were randomly assigned to forced air-warming or control groups ( identical cover applied with forced air-warming unit switched off ) .\
METHODS	A blinded investigator assessed oral temperature , shivering , and thermal comfort scores at 15-min intervals until discharge from the postanesthetic care unit .\
METHODS	Umbilical cord blood gases and Apgar scores were also measured after delivery .\
RESULTS	The maximum core temperature changes were similar in the two groups ( -1.3 degrees C + / - 0.4 degrees C vs -1.3 degrees C + / - 0.3 degrees C for the forced air-warming group and control group , respectively ; P = 0.8 ) .\
RESULTS	Core hypothermia ( < or = 35.5 degrees C ) occurred in 8 of 15 patients receiving forced air-warming and in 10 of 15 unwarmed patients ( P = 0.5 ) .\
RESULTS	The incidence and severity of shivering did not significantly differ between groups .\
RESULTS	Umbilical cord blood gases and Apgar scores were similar in both groups ( P = NS ) .\
CONCLUSIONS	We conclude that intraoperative lower body forced air-warming does not prevent intraoperative hypothermia or shivering in women undergoing elective cesarean delivery with spinal anesthesia .\
\
###9027792\
BACKGROUND	When a peritoneal dialysis catheter is inserted intra-abdominally in a patient starting peritoneal dialysis ( PD ) there is always a risk for postoperative wound infection and peritonitis .\
BACKGROUND	At our centre , PD is started immediately after the dialysis catheter is inserted .\
BACKGROUND	This may increase the postoperative risk for peritonitis and wound infection .\
BACKGROUND	The aim of this prospective , randomized , study was to evaluate whether the incidence of microbial growth postoperatively ( within 10 days ) after catheter insertion could be reduced by prophylactic antibiotic therapy .\
METHODS	During a period of 27 months , 38 patients , who consecutively entered the PD programme , ( 11 women and 27 men , mean age 57 years ) were included in the study .\
METHODS	Eighteen patients were given cefuroxime 1.5 g i.v. preoperatively and 250 mg i.p. in the first dialysis bag ( containing 1 litre fluid ) as prophylaxis .\
METHODS	Twenty patients were not given prophylactic antibiotics ( control group ) .\
METHODS	All catheter insertions were performed in an operating theatre by the same surgeons using the same technique .\
RESULTS	In the test group , none of the patients showed microbial growth in the dialysis fluid during the post-operative period , while in the control group six of 20 patients ( 30 % ) suffered from such growth ( P = 0.021 ) .\
CONCLUSIONS	Prophylactic treatment by cefuroxime i.v. pre - and i.p. perioperatively may reduce the risk for microbial growth and peritonitis after insertion of a Tenckhoff catheter .\
\
###24767638\
OBJECTIVE	Patient-controlled epidural analgesia ( PCEA ) and continuous epidural infusion ( CEI ) are popular and effective methods for pain relief during labor ; however , there are concerns about increasing rates of cesarean section ( C/S ) and instrumental delivery .\
OBJECTIVE	This prospective study investigated the effect of PCEA and CEI with different formulas on labor and the mode of delivery in nulliparous women .\
METHODS	A total of 480 nulliparous women were randomized into four groups , with 120 in each .\
METHODS	Group A received a loading dose of 10mL of 1mg/mL ropivacaine with 2g/mL fentanyl , then an intermittent bolus of 5mL with a background infusion of 5mL/hour by PCEA .\
METHODS	Group B received the same PCEA formula as Group A with 0.8 mg/mL bupivacaine .\
METHODS	Group C received the same formula as Group A by CEI with 1mg/mL ropivacaine at a rate of 10mL/hour .\
METHODS	Group D received the same formula as Group C with 0.8 mg/mL bupivacaine .\
METHODS	The rates of C/S and instrumental delivery and the incidence of side effects were recorded .\
RESULTS	The rates of C/S were significantly different between Groups A and C , Groups A and D , and Groups B and D.\
RESULTS	The rates of instrumental delivery for normal spontaneous delivery were significantly different between Groups A and B , A and D , B and C , and C and D.\
CONCLUSIONS	The C/S rate was higher in Groups C and D ; however , the instrumental delivery rate was lower in Groups A and C.\
CONCLUSIONS	We conclude that PCEA with 1mg/mL ropivacaine might provide the greatest benefit for labor analgesia .\
\
###17684522\
OBJECTIVE	To clearly clarify the protective effect of vitamin A supplementation on immune function of well-nourished children suffering from vitamin A deficiency .\
METHODS	Three hundred sixty-two children in two kindergartens in Wuhan China were enrolled .\
METHODS	Detailed dietary assessment and anthropometry were undertaken to facilitate the exclusion of malnourished children .\
METHODS	Seventy vitamin A-deficient children with informed consent were randomly divided into the vitamin A-deficient-supplemented group and vitamin A-deficient placebo group , 35 vitamin A-sufficient children ( age - and sex-matched with the vitamin A-deficient-supplemented group children ) were selected as vitamin A-sufficient placebo group .\
METHODS	The baseline and follow-up level of selected immune parameters of the 105 children in three intervention groups were compared .\
RESULTS	The total proportion of severe and marginal vitamin A-deficient children was 10.9 and 21.96 % , respectively .\
RESULTS	At baseline , the serum complement C3 and sIgA level of vitamin A-sufficient children was significantly higher than that of vitamin A-deficient children ( P < 0.05 ) .\
RESULTS	However , the serum lysozyme level of vitamin A-sufficient children was inversely lower .\
RESULTS	After intervention , vitamin A-deficient-supplemented children increased serum vitamin A , complement C3 and sIgA level , but their serum lysozyme level inversely decreased .\
CONCLUSIONS	Vitamin A deficiency was still a serious health problem in children in China cities .\
CONCLUSIONS	Vitamin A supplementation was efficacious in ameliorating serum vitamin A status and partially impaired immune function of well-nourished children suffering from vitamin A deficiency .\
\
###18928218\
OBJECTIVE	In this prospective , randomized clinical study the authors sought to evaluate the effects of locally applied mitomycin C on peridural fibrosis during lumbar microdiscectomy .\
METHODS	Patients undergoing lumbar disc surgery were randomly divided into 2 groups .\
METHODS	Thirty patients had 1 mg/ml mitomycin C applied at the site of discectomy for 5 minutes , and 30 age - and sex-matched patients underwent lumbar microdiscectomy without mitomycin C application as the control group .\
METHODS	The groups were compared for degree of postoperative neurological function , radicular/back pain , and degree of peridural fibrosis on MR imaging 6 months after the operation .\
RESULTS	The median follow-up was 18 months .\
RESULTS	No serious drug adverse effects and no clinically significant laboratory adverse effects were reported in patients in the mitomycin C group .\
RESULTS	Patients in both groups showed similar clinical recoveries postoperatively .\
RESULTS	On postoperative evaluation of the MR images , pain scores , and neurological function , patients given mitomycin C have shown no reduction of peridural fibrosis either clinically or radiographically .\
CONCLUSIONS	Mitomycin C is easy to use and safe in patients undergoing lumbar microdiscectomy .\
CONCLUSIONS	However , no benefit was observed either clinically or radiographically in this study .\
\
###20920825\
OBJECTIVE	To investigate the cause of visual acuity ( VA ) loss in patients with neovascular age-related macular degeneration ( AMD ) receiving monthly ranibizumab injections in the pivotal ranibizumab phase III trials .\
METHODS	Retrospective analysis .\
METHODS	The Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab In the treatment of Neovascular AMD ( MARINA ) and Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD ( ANCHOR ) trials .\
METHODS	Demographics and lesion characteristics at baseline and month 24 were compared in patients with 15 letters VA loss and patients with 15 letters VA gain from baseline to month 24 .\
METHODS	Additional evaluations of fundus photographs from these patients were performed to assess features of non-exudative AMD , such as geographic atrophy ( GA ) and retinal pigment epithelium ( RPE ) abnormalities .\
METHODS	Differences in lesion characteristics between patients who lost versus gained 15 letters of VA from baseline to month 24 .\
RESULTS	At month 24 , 9 % of ranibizumab-treated patients from MARINA and 10 % of ranibizumab-treated patients from ANCHOR had lost 15 letters VA ; 30 % of ranibizumab-treated patients from MARINA and 38 % of ranibizumab-treated patients from ANCHOR had gained 15 letters VA. .\
RESULTS	Baseline characteristics associated with VA loss at month 24 included older age , better VA , and larger lesions .\
RESULTS	At month 24 , an increased area of RPE abnormality was associated with VA loss in both the MARINA ( P = 0.0008 ) and ANCHOR ( P = 0.0046 ) trials .\
RESULTS	Increased total lesion area at month 24 was associated with VA loss in both trials .\
RESULTS	In MARINA , the increase in total lesion area was attributable to an increase in the angiographic designation of atrophic scar among VA losers ( P = 0.0043 ) , but in ANCHOR it was attributable to an increased area of choroidal neovascularization ( CNV ) ( P = 0.039 ) but not an increased area of leakage ( P = 0.17 ) .\
RESULTS	Increased areas of GA , fibrosis , and hemorrhage were not associated with VA loss .\
CONCLUSIONS	Vision loss after 2 years of monthly ranibizumab therapy was associated with lesion characteristics commonly associated with suppressed CNV , such as pigmentary abnormalities , atrophic scar , and the absence of leakage .\
CONCLUSIONS	Future VA improvements in patients receiving ranibizumab therapy may require preservation of photoreceptor and RPE function rather than strategies that target CNV .\
\
###18165571\
BACKGROUND	Spectral entropy is an electroencephalogram-based monitoring technique with a frequency band enlarged to include the electromyogram spectrum , which is intended to help to assess analgesia .\
BACKGROUND	Although its correlation with hypnosis has been shown , its performance during a noxious stimulation and the influence of neuromuscular blockade have not been described .\
METHODS	In this prospective , open , multicenter study , 105 patients received propofol then remifentanil target-controlled infusion for induction of anesthesia , with randomized remifentanil targets ranging from 2 to 8 ng/mL .\
METHODS	Half of the patients received neuromuscular blockade .\
METHODS	Intubation and incision were used as standard noxious stimulations , motor or hemodynamic responses were recorded , and spectral entropy values before and after stimulations were compared between responders and nonresponders .\
RESULTS	No difference was found in response entropy ( RE ) , state entropy ( SE ) , or ( RE - SE ) between patients with or without hemodynamic response to stimulations .\
RESULTS	Patients with motor response to intubation had higher values of RE , SE , and ( RE - SE ) both before and after the intubation than patients with no response .\
RESULTS	These results were confirmed by a prediction probability analysis , showing a significant but weak predictive value of entropy for motor response only .\
CONCLUSIONS	Entropy predicted a motor response to noxious stimulations but not a hemodynamic response , which limits its usefulness for assessing the analgesic component of anesthesia in paralyzed patients .\
CONCLUSIONS	High values ( RE > 55 ) before the stimulation should be avoided in order to decrease the risk of motor response , but lower values might not prevent this response when the opioid concentration is insufficient , despite an adequate hypnosis .\
\
###18073061\
OBJECTIVE	To observe the anti-viral therapy effect on HBV reactivation in malignant tumor patients and hepatitis B virus carriers after their cancer chemotherapy .\
METHODS	Thirteen cancer patients but also chronic hepatitis B virus carriers were enrolled in this study .\
METHODS	They were randomly put into two groups .\
METHODS	Eight patients were put in the therapeutic group .\
METHODS	They all had abnormal liver functions induced by the reactivation of HBV after their cancer chemotherapy .\
METHODS	Then they were treated with lamivudine .\
METHODS	The other 5 cases were treated with lamivudine before their cancer chemotherapy when their serum HBV DNA levels were less than 10 ( 3 ) copies/ml ( preventive therapeutic group ) .\
METHODS	The two groups were followed-up with liver function tests and serum HBV DNA level measurements .\
RESULTS	Among the 8 cases of the therapeutic group , 5 cases died of liver failure ; cancer chemotherapy was postponed or even terminated in 3 patients due to liver function abnormality and anti-virus treatment was started .\
RESULTS	In the preventive therapy group , no HBV reactivation was observed in any of the 5 cases .\
CONCLUSIONS	For HBV carrier cancer patients , an anti-viral therapy before their cancer chemotherapy seems to be very important .\
\
###19409339\
BACKGROUND	The aim of this study was to evaluate the effectiveness of early orthodontic treatment with the Twin-block appliance for the treatment of Class II Division 1 malocclusion .\
BACKGROUND	This was a multi-center , randomized , controlled trial with subjects from 14 orthodontic clinics in the United Kingdom .\
METHODS	The study included 174 children aged 8 to 10 years with Class II Division 1 malocclusion ; they were randomly allocated to receive treatment with a Twin-block appliance or to an initially untreated control group .\
METHODS	The subjects were then followed until all orthodontic treatment was completed .\
METHODS	Final skeletal pattern , number of attendances , duration of orthodontic treatment , extraction rate , cost of treatment , and the child 's self-concept were considered .\
RESULTS	At the end of the 10-year study , 141 patients either completed treatment or accepted their occlusion .\
RESULTS	Data analysis showed that there was no differences between those who received early Twin-block treatment and those who had 1 course of treatment in adolescence with respect to skeletal pattern , extraction rate , and self-esteem .\
RESULTS	Those who had early treatment had more attendances , received treatment for longer times , and incurred more costs than the adolescent treatment group .\
RESULTS	They also had significantly poorer final dental occlusion .\
CONCLUSIONS	Twin-block treatment when a child is 8 to 9 years old has no advantages over treatment started at an average age of 12.4 years .\
CONCLUSIONS	However , the cost of early treatment to the patient in terms of attendances and length of appliance wear is increased .\
\
###21893941\
BACKGROUND	Growth hormone ( GH ) treatment in short children born small for gestational age ( SGA ) may result in metabolic changes with potential long-term effects .\
METHODS	149 short SGA children ( mean birth weight 2.0 0.6 kg , age 5.5 1.5 years , height standard deviation score ( SDS ) -3.1 0.6 ) were randomised to : low-dose GH therapy ( 0.033 mg/kg/day ) for 2 years ; high-dose GH therapy ( 0.100 mg/kg/day ) for 1 year , or mid-dose GH therapy ( 0.067 mg/kg/day ) for 1 year .\
METHODS	Leptin , ghrelin , insulin-like growth factor-I ( IGF-I ) , IGF binding protein-1 ( IGFBP-1 ) , lipids , fasting blood glucose and fasting insulin were assessed at baseline , 12 and 24 months .\
RESULTS	After 1 year of active treatment , GH significantly reduced serum ghrelin and increased IGF-I SDS and insulin levels .\
RESULTS	Regression analysis showed an inverse correlation between ghrelin and IGF-I SDS ( p < 0.001 ) .\
RESULTS	Leptin and IGFBP-1 also declined ( both p < 0.05 ) .\
RESULTS	Changes in insulin levels reversed upon discontinuation .\
RESULTS	Improvements in lipid profile were nonsignificant and fasting blood glucose levels remained within the normal range .\
CONCLUSIONS	In short SGA children , ghrelin and leptin reductions associated with GH treatment may occur through a negative feedback loop of the GH-IGF-I axis .\
CONCLUSIONS	Consequently , via ghrelin and leptin suppression , GH treatment may modify food intake and body composition and potentially improve long-term metabolic outcomes .\
\
###8605753\
OBJECTIVE	To evaluate the safety and efficacy of iodixanol ( Visipaque ) in phlebography in order to obtain experience from the use of this contrast medium in this i.v. indication .\
METHODS	Phlebography was performed in 150 patients , as a comparative prospective , double-blind , randomized parallel group study comparing iodixanol 270 mgI/ml with ioxaglate 320 mgI/ml .\
METHODS	The tolerability was assessed from occurrence of discomfort , adverse events up to 30 min following injection and late adverse events .\
METHODS	Efficacy was assessed by recording the diagnostic information on each venous segment .\
METHODS	Statistical analysis was performed using the Cochran-Mantel-Haenszel test in order to correct for a possible centre effect .\
RESULTS	Frequency of patients reporting discomfort ( P = 0.002 ) or adverse events ( P < 0.001 ) was statistically significantly lower after the injection of iodixanol than after ioxaglate .\
RESULTS	There was no statistical difference regarding late adverse events and diagnostic information .\
CONCLUSIONS	Iodixanol 270 mgI/ml yielded the same diagnostic information as ioxaglate 320 mgI/ml and was associated with fewer patients reporting adverse events and discomfort .\
\
###24364223\
BACKGROUND	The importance of vitamin D on bone health and osteoporosis was studied by many researchers .\
BACKGROUND	The main role of the Vitamin D is to absorb calcium and phosphate and increase bone mineralization .\
BACKGROUND	Older people are at an increased risk of the inadequate vitamin D production in the skin because of lower sun exposure and reduced ability of the skin to synthesize vitamin D.\
OBJECTIVE	The aim of this clinical trial was to evaluate the efficacy and tolerability of short-term ( 2 weeks ) low energy UVB irradiation in postmenopausal women with osteoporosis using bone mineral density and bone turnover markers .\
METHODS	A three-month , single-blinded , randomized , placebo-controlled clinical trial was conducted at the University hospital in Daegu , Republic of Korea .\
METHODS	Fifty-two postmenopausal Korean women ( older than 65 years ) with osteoporosis were randomly allocated to have either low energy UVB or placebo for 30 minutes a day for two weeks of treatment during winter .\
METHODS	Laboratory analysis and physical examination before and 4 , 8 and 12 weeks after treatment were carried out and BMD was measured before and 8 and 12 weeks after treatment .\
METHODS	The effects of time and treatment interaction between these two groups were evaluated by repeated-measure two-factor analysis , and subgroup analysis was performed to examine UVB effect on the vitamin D insufficient group [ serum 25 ( OH ) D3 concentration < 30 ng/mL ] .\
RESULTS	In vitamin D insufficient group , the effect of UVB irradiation on vitamin D and bone ALP as well as additional benefit on bone formation was confirmed .\
RESULTS	The vitamin D insufficient group showed statistically significant increment in serum 25 ( OH ) D3 compared with the normal group ( p < 0.05 ) .\
RESULTS	However , there was no significant difference between two groups in the other bone turnover markers , such as serum calcium , PTH-C , serum osteocalcin , serum CTX and BMD .\
CONCLUSIONS	Low-energy-short-term UVB radiation for postmenopausal women may be of use in vitamin D synthesis .\
CONCLUSIONS	There was a modest benefit in change of bone ALP especially in women with the insufficient vitamin D.\
\
###21832958\
BACKGROUND	Calcineurin inhibitors ( CNIs ) play the key role in immunosuppressive protocols yet are often associated with numerous side effects .\
BACKGROUND	Renal insufficiency , hypertension , hyperglycemia , and increased risk of secondary malignancy are major problems in short - and long-term follow-up of liver transplant patients .\
BACKGROUND	Mycophenolate mofetil ( MMF ) has proved to be a potent immunosuppressive agent free of the CNI-associated side effects .\
METHODS	One hundred fifty patients who received liver transplantation at our institution ( 1998-2003 ) were prospectively randomized : 75 patients continued CNI standard therapy , 75 patients were switched to MMF monotherapy , and follow-up was 5 years .\
METHODS	Incidence of rejection , renal complication , cardiovascular , neurological and gastrointestinal adverse effects , and diabetes and malignancy development was recorded .\
METHODS	Graft biopsies were performed every 2 to 3 years .\
RESULTS	No significant difference regarding the incidence of acute rejection was detected .\
RESULTS	A trend to higher rejection frequency was apparent in the MMF monotherapy group .\
RESULTS	Chronic rejection was absent ; organ and patient survival were identical in the two groups .\
RESULTS	No significant difference occurred concerning the incidence of cardiovascular , gastrointestinal or neurological adverse effects , or the development of malignancies .\
RESULTS	Renal function improved significantly in patients with renal insufficiency when patients treated with CNI were switched to MMF monotherapy .\
CONCLUSIONS	MMF monotherapy may serve as safe long-term immunosuppression after liver transplantation for a subgroup of patients .\
CONCLUSIONS	Especially for patients with renal insufficiency MMF offers immunosuppression without the risk of nephrotoxicity .\
\
###19066295\
BACKGROUND	The loss of lean body mass ( LBM ) negatively influences the outcome in bariatric surgery .\
BACKGROUND	Impaired GH secretion is frequent in obese patients .\
OBJECTIVE	Our objective was to investigate if GH treatment prevents LBM loss in the early postoperative period .\
METHODS	This was an open , prospective , randomized , and controlled study .\
METHODS	A total of 24 women ( body mass index : 44.4 + / - 7.6 kg/m ( 2 ) , aged 36.8 + / - 11.7 yr ) undergoing laparoscopic-adjustable silicone gastric banding ( LASGB ) and with GH deficiency after LASGB was included in the study .\
METHODS	Group A ( n = 12 ) included a standardized diet regimen and exercise program plus recombinant human GH ( 0.5 + / - 0.13 mg every day ) , and group B ( n = 12 ) included a standardized diet regimen and exercise program .\
METHODS	The follow-up duration was 6 months .\
RESULTS	The excess of body weight loss did not differ between groups A and B after 3 and 6 months .\
RESULTS	At 3 months , LBM loss was lower ( P < 0.0001 ) and fat mass ( FM ) loss was higher ( P = 0.02 ) in group A than group B.\
RESULTS	At 3 and 6 months , appendicular skeletal muscle mass loss was lower ( P = 0.000 ) in group A than group B.\
RESULTS	At 3 ( P = 0.0003 and 0.0005 , respectively ) and 6 months ( P < 0.0001 and 0.0002 , respectively ) , the percent changes of FM and lean body mass were significantly higher in group A than group B.\
RESULTS	In both groups fasting and postglucose area under the plasma concentration-time curve insulin significantly reduced .\
RESULTS	The homeostasis model assessment of insulin and insulin sensitivity indexes and total to high-density lipoprotein cholesterol ratio improved only in group A.\
CONCLUSIONS	GH treatment for 6 months after LASGB reduces loss in LBM and appendicular skeletal muscle mass during a standardized program of low-calorie diet and physical exercise program , with improvement of lipid profile and without a deterioration of glucose tolerance .\
\
###24724835\
OBJECTIVE	The US Food and Drug Administration has said that oral preparations containing benzocaine should only be used in infants under strict medical supervision , due to the rare , but potentially fatal , risk of methemoglobinemia .\
OBJECTIVE	This study aimed to determine the analgesic effect of topical application of benzocaine prior to lingual frenotomy in infants with symptomatic tongue-tie .\
OBJECTIVE	We hypothesised that the duration of crying immediately following frenotomy with topical benzocaine would be shorter than with no benzocaine .\
METHODS	This randomised controlled study compared the length of crying after lingual frenotomy in term infants who did , or did not , receive topical application of benzocaine to the lingual frenulum prior to the procedure .\
RESULTS	We recruited 21 infants to this study .\
RESULTS	Crying time was less than one minute in all of the subjects .\
RESULTS	The average length of crying in the benzocaine group ( 21.6 13.6 sec ) was longer than the length of crying in the control group ( 13.1 4.0 sec ) , p = 0.103 .\
CONCLUSIONS	Contrary to our hypothesis , infants who were treated with topical benzocaine did not benefit from topical analgesia in terms of crying time .\
CONCLUSIONS	The use of benzocaine for analgesia prior to lingual frenotomy in term infants should therefore be discouraged .\
\
###20469954\
OBJECTIVE	To evaluate healthcare utilization and costs following a cardiovascular disease ( CVD ) screening and educational special intervention ( SI ) compared with a control intervention ( CIN ) at 1 year in the Family-Based Intervention Trial for Heart Health .\
METHODS	Participants randomized to SI for screening and periodic lifestyle counseling were compared with participants randomized to CIN for resource utilization and associated costs at 1 year .\
METHODS	A total of 421 participants ( 67 % women and 37 % minorities ) were healthy family members of hospitalized patients with CVD who had 1-year follow-up resource utilization data .\
METHODS	Resource utilization was systematically measured using a standardized questionnaire in both study groups and was validated by medical records in a subsample .\
METHODS	Outcomes included provider visits , diagnostic studies , laboratory assessment , medication use , behavioral program enrollment , emergency department ( ED ) visits , hospital admissions , and healthcare costs .\
RESULTS	At 1 year , there were significantly fewer overall provider visits ( P = .04 ) and psychiatrist visits ( P = .03 ) in SI versus CIN .\
RESULTS	There was a nonsignificant trend toward fewer ED visits , decreased hospital admissions , and shorter inpatient length of stay in SI versus CIN .\
RESULTS	Estimated healthcare expenditures for CIN exceeded those for SI by $ 590 per participant .\
RESULTS	The cost of the 1-year intervention was $ 95 per participant .\
CONCLUSIONS	A 1-year standardized low-cost screening and educational intervention was associated with significantly fewer provider visits and with a nonsignificant trend toward reduced healthcare utilization for several parameters .\
CONCLUSIONS	The long-term effect on outcomes and costs deserves further study .\
\
###24167552\
BACKGROUND	Previous studies have observed an altitude-dependent increase in central apneas and a shift towards lighter sleep at altitudes > 4000 m. Whether altitude-dependent changes in the sleep EEG are also prevalent at moderate altitudes of 1600 m and 2600 m remains largely unknown .\
BACKGROUND	Furthermore , the relationship between sleep EEG variables and central apneas and oxygen saturation are of great interest to understand the impact of hypoxia at moderate altitude on sleep .\
METHODS	Fourty-four healthy men ( mean age 25.0 5.5 years ) underwent polysomnographic recordings during a baseline night at 490 m and four consecutive nights at 1630 m and 2590 m ( two nights each ) in a randomized cross-over design .\
RESULTS	Comparison of sleep EEG power density spectra of frontal ( F3A2 ) and central ( C3A2 ) derivations at altitudes compared to baseline revealed that slow-wave activity ( SWA , 0.8-4 .6 Hz ) in non-REM sleep was reduced in an altitude-dependent manner ( ~ 4 % at 1630 m and 15 % at 2590 m ) , while theta activity ( 4.6-8 Hz ) was reduced only at the highest altitude ( 10 % at 2590 m ) .\
RESULTS	In addition , spindle peak height and frequency showed a modest increase in the second night at 2590 m. SWA and theta activity were also reduced in REM sleep .\
RESULTS	Correlations between spectral power and central apnea/hypopnea index ( AHI ) , oxygen desaturation index ( ODI ) , and oxygen saturation revealed that distinct frequency bands were correlated with oxygen saturation ( 6.4-8 Hz and 13-14 .4 Hz ) and breathing variables ( AHI , ODI ; 0.8-4 .6 Hz ) .\
CONCLUSIONS	The correlation between SWA and AHI/ODI suggests that respiratory disturbances contribute to the reduction in SWA at altitude .\
CONCLUSIONS	Since SWA is a marker of sleep homeostasis , this might be indicative of an inability to efficiently dissipate sleep pressure .\
\
###19090594\
OBJECTIVE	To evaluate , in a randomized controlled way , the use of a daytime wetting alarm in a day-care center during three consecutive weeks in healthy children .\
METHODS	Thirty-nine healthy young children , between 18 and 30 months old , were selected at random for a wetting alarm diaper training ( n = 27 ) or control wearing a placebo alarm ( n = 12 ) .\
METHODS	Toilet behavior was observed during a period of 10 hr by independent observers before , at the end of , and 2 weeks after training .\
METHODS	Children were defined as completing daytime toilet training when the child wore undergarments , showed awareness of a need to void , initiated the toileting without prompts or reminder from the trainer and had maximum one leakage accident per day .\
RESULTS	Children in the wetting alarm diaper training group achieved independent bladder control in 51.9 % and did significantly better than in the control group ( 8.3 % ) ( P = 0.013 ) .\
RESULTS	The results were sustained during the following 14 days ( P = 0.013 ) .\
CONCLUSIONS	The wetting alarm diaper training is an effective option for toilet training young healthy children in a day-care center .\
CONCLUSIONS	It offers day-care providers clear guidelines and limits the time to complete toilet training in many children without putting too much burden on the child and the day-care center activities .\
\
###16556674\
BACKGROUND	Recent evidence showed that ultrasound-guided embryo transfer significantly increases successful implantation compared to the clinical touch method .\
BACKGROUND	It has been postulated that new echodense catheters which are more readily detectable by ultrasound may refine transfer techniques even more , thus improving IVF outcome .\
METHODS	A prospective , randomized , controlled trial comparing IVF outcome for women undergoing embryo transfer under ultrasound guidance by a single healthcare provider with random assignment according to a computer-generated randomization table to either standard soft Wallace catheter ( standard catheter group , n = 95 ) or the new echogenic soft Wallace catheter ( echogenic catheter group , n = 98 ) .\
RESULTS	The use of the echodense catheter facilitated catheter identification under ultrasound , and thus the duration of the embryo transfer procedure since the loaded catheter was handed to the physician and up to embryo discharge was significantly shorter in the echogenic catheter group as compared with the standard catheter group .\
RESULTS	There were 39 and 53 clinical pregnancies in the standard catheter ( 41 % ) and echogenic catheter ( 54.1 % ) groups , respectively .\
RESULTS	This was not statistically significant ( P = 0.08 ) according to the OR ( 0.6 ) and CIs ( 0.33-1 .04 ) .\
RESULTS	However , twin pregnancy rate was significantly increased ( P < 0.01 ) with the use of the new catheter which was the underlying source for obtaining significant increase in implantation rate in this group ( 37.1 % ) as compared with the standard catheter group ( 23.2 % ) .\
CONCLUSIONS	This pilot study suggests that the use of the echogenic Wallace catheter simplifies ultrasound-guided embryo transfer but not definite benefit in terms of pregnancy rates was obtained .\
CONCLUSIONS	In contrast , the use of the new catheter was associated with a significant increase in the number of twin pregnancies .\
\
###21735533\
BACKGROUND	Although current clinical guidelines recommend the use of thrombus aspiration ( TA ) during primary percutaneous coronary intervention ( PPCI ) , previous studies evaluating TA demonstrated contradictory results .\
BACKGROUND	The aim of this study was to evaluate long-term clinical outcome after TA in adjunct to PPCI for acute ST-segment myocardial infarction ( STEMI ) , as compared with conventional treatment , with the use of paclitaxel-eluting stents or bare-metal stents .\
METHODS	We analyzed data of the PASSION trial , in which 619 patients with STEMI were randomly assigned to a paclitaxel-eluting stent or a bare-metal stent .\
METHODS	TA was performed in 311 patients ( 50.2 % ) .\
METHODS	Clinical endpoints at 2 years were compared between patients who received TA during PPCI with patients who underwent conventional PPCI .\
METHODS	The primary outcome of interest was a composite of cardiac death , recurrent myocardial infarction ( MI ) , or target-lesion revascularization ( TLR ) .\
METHODS	A propensity score model was made to account for baseline differences that could have affected the probability of performing TA .\
RESULTS	Complete follow-up was available for 598 patients ( 96.6 % ) .\
RESULTS	The cumulative incidence of the combined outcome measure of cardiac death , recurrent MI , or TLR was 40 ( 13.0 % ) in the TA group and 41 ( 13.5 % ) in the conventional PPCI group ( HR 0.96 ; 95 % CI 0.62-1 .47 ; P = 0.84 ) .\
RESULTS	Also after adjusting for propensity score , no significant difference in event rate was observed between both treatment groups .\
CONCLUSIONS	In this post-hoc analysis of the PASSION trial , TA in adjunct to PPCI did not affect rates of major adverse cardiac events at 2 years follow-up , as compared with conventional PPCI .\
\
###17078279\
OBJECTIVE	The main objective was to compare the presence of interlayer gaps between 2 hybrid composites placed using a microlayer and a 2-layer technique .\
METHODS	Standardized Class 1 cavities were prepared in 40 extracted posterior teeth .\
METHODS	Two resin composite materials were used .\
METHODS	The control group , group A , consisted of samples of the materials extruded out of the manufacturers ' syringes .\
METHODS	Group B consisted of 10 teeth restored using 2 layers per restoration .\
METHODS	Group C consisted of 30 teeth restored using 6 microlayers per restoration .\
METHODS	A scanning electron microscope was used to detect voids in the samples .\
RESULTS	Round , well-defined voids were found in 85 % to 100 % of the samples within the bulks of the resin composite materials only .\
RESULTS	A statistically significant relationship between the type of composite and presence of bubbles ( Fisher exact test , P = .04 ) was found among the 2-layer technique group .\
RESULTS	No statistically significant difference ( Fisher exact test , P = .48 ) was found among the microlayer technique group .\
RESULTS	Irregular interlayer gaps were found in 5 % to 15 % of specimens within areas between bulks of composite , as detected by an electron microscope based on the different densities of the bulks of composite and the interlayer areas .\
RESULTS	No such statistically significant relationship was found ( Fisher exact , P = .62 ) among the study groups .\
CONCLUSIONS	Voids are routinely found in bulks of composite materials .\
CONCLUSIONS	Higher incidences of interlayer gaps in the 2-layer samples suggest that the use of a microlayering technique may result in fewer gaps .\
\
###22824435\
BACKGROUND	Several recent randomized trials comparing everolimus-eluting stent ( EES ) and sirolimus-eluting stent ( SES ) reported similar outcomes .\
BACKGROUND	However , only 1 trial was powered for a clinical end point , and no trial was powered for evaluating target-lesion revascularization .\
RESULTS	Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan .\
RESULTS	The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization .\
RESULTS	From February and July 2010 , 3197 patients were randomly assigned to receive either EES ( 1597 patients ) or SES ( 1600 patients ) .\
RESULTS	At 1 year , the primary efficacy end point of target-lesion revascularization occurred in 65 patients ( 4.3 % ) in the EES group and in 76 patients ( 5.0 % ) in the SES group , demonstrating noninferiority of EES to SES ( P ( noninferiority ) < 0.0001 , and P ( superiority ) = 0.34 ) .\
RESULTS	Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups ( 0.32 % versus 0.38 % , P = 0.77 ) .\
RESULTS	An angiographic substudy enrolling 571 patients ( EES , 285 patients and SES , 286 patients ) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss ( 0.060.37 mm versus 0.020.46 mm , P ( noninferiority ) < 0.0001 , and P ( superiority ) = 0.24 ) at 27863 days after index stent implantation .\
CONCLUSIONS	One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy .\
CONCLUSIONS	One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis .\
BACKGROUND	URL : http://www.clinicaltrials.gov .\
BACKGROUND	Unique identifier : NCT01035450 .\
\
###11393368\
OBJECTIVE	To determine whether hydrochlorothiazide ( HCTZ ) reduces urinary calcium excretion in dogs with calcium oxalate urolithiasis .\
METHODS	Original study .\
METHODS	8 dogs with calcium oxalate urolithiasis .\
METHODS	4 treatment protocols were evaluated in each dog ( a low calcium , low protein diet designed to prevent calcium oxalate urolith formation with and without administration of HCTZ [ 2 mg/kg ( 0.9 mg/lb ) of body weight , PO , q 12 h ] and a maintenance diet with higher quantities of protein and calcium with and without administration of HCTZ ) .\
METHODS	At the end of each 2-week treatment period , 24-hour urine samples were collected .\
METHODS	Blood samples were collected during the midpoint of each urine collection period .\
METHODS	Analysis of variance was performed to evaluate the effects of HCTZ and diet on urine and serum analytes .\
RESULTS	Hydrochlorothiazide significantly decreased urine calcium and potassium concentration and excretion .\
RESULTS	Hydrochlorothiazide also significantly decreased serum potassium concentration .\
RESULTS	Compared with the maintenance diet , the urolith prevention diet significantly decreased urine calcium and oxalic acid concentration and excretion .\
RESULTS	Dogs consuming the urolith prevention diet had significantly lower serum concentrations of albumin and urea nitrogen .\
CONCLUSIONS	Administration of HCTZ decreased urine calcium excretion in dogs with a history of calcium oxalate urolith formation .\
CONCLUSIONS	The greatest reduction in urine calcium concentration and excretion was achieved when dogs received HCTZ and the urolith prevention diet .\
CONCLUSIONS	Results of this study suggest that the hypocalciuric effect of HCTZ will minimize recurrence of calcium oxalate urolith formation in dogs ; however , long-term controlled clinical trials are needed to confirm the safety and effectiveness of HCTZ .\
\
###19827881\
BACKGROUND	Riboflavin-fortified salt is now supplied in the diet for residents who live in high incidence areas for esophageal squamous cell carcinoma in China .\
METHODS	All residents from 21 townships in Cixian , Hebei province were divided into an intervention group ( 9 townships , 11,382 people ) who took up riboflavin-fortified salt and a control group ( 12 townships , 10,711 people ) who were free from riboflavin-fortified salt .\
METHODS	Some 1,300 of the control group and 950 of the intervention group were randomly selected to undergo endoscopy examination using iodine dying with multi-point biopsy and histopathology examination .\
METHODS	Among them 155 of the intervention group and 120 of the control group were tested for the blood riboflavin level with reference to the erythrocyte glutathione reductase activity coefficient ( EGRAC ) .\
METHODS	Esophageal squamous cell carcinoma incidence data were further obtained from the Cixian Cancer Registry .\
RESULTS	The results of endoscopy suggested the mucosal status of the intervention group to be better than that of the control group .\
RESULTS	It showed 82.1 % of the mucosal status of control group to be normal , 14.8 % to have dysplasia , and 3.1 % pre-cancer or cancer , respectively , as compared to 84.8 % , 13.6 % and 1.6 % , respectively , for the intervention group .\
RESULTS	The mean EGRAC values for the intervention and control groups were 1.452 and 1.606 , respectively ( P < 0.01 ) ; compared with normal mucous membrane of esophagus , the lack of riboflavin increased the risk of esophageal squamous cell carcinoma ( OR = 3.921 , 95 % CI = 1.853 approximately 11.936 ) , but the risk of dysplasia did not increase ( OR = 3.421 , 95 % CI = 0.912-10 .159 ) ; after intervention , the six years average esophageal squamous cell carcinoma incidence of the intervention group ( 112.46 / 100,000 ) was lower than in the control group ( 142.11 / 100,000 ) , although there was no statistical significance ( u = 1.858 , P > 0.05 ) .\
CONCLUSIONS	It proved practical and effective to improve the status of riboflavin and esophageal mucosa by taking up riboflavin-fortified salt .\
\
###24581245\
BACKGROUND	Untreated behavioral and mental health problems beginning in early childhood are costly problems affecting the long-term health and wellbeing of children , their families , and society .\
BACKGROUND	Although parent training ( PT ) programs have been demonstrated to be a cost-effective intervention modality for treating childhood behavior problems , they have been less effective for children from low-income and underserved racial and ethnic populations .\
BACKGROUND	The purpose of this randomized trial is to compare the effectiveness , cost , and social validity of two manualized evidence-based PT programs that were developed and tested on different populations and employ different delivery models : ( 1 ) The Chicago Parent Program ( CPP ) , a group-based program developed in collaboration with a community advisory board of African-American and Latino parents ; and ( 2 ) Parent-Child Interaction Therapy ( PCIT ) , an individualized parent-child coaching model considered to be ` the gold standard ' for parents of children with externalizing behavior problems .\
METHODS	This trial uses an experimental design with randomization of parents seeking behavioral treatment for their 2 - to 5-year-old children at a mental health clinic in Baltimore , MD ( 80 % African-American or multi-racial ; 97 % receiving Medicaid ) .\
METHODS	Using block randomization procedures , 262 parents are randomized to CPP or PCIT .\
METHODS	Clinicians ( n = 13 ) employed in the mental health clinic and trained in CPP or PCIT are also recruited to participate .\
METHODS	Primary outcomes of interest are reductions in child behavior problems , improvements in parenting , perceived value of the interventions from the perspective of parents and clinicians , and cost .\
METHODS	Parent distress and family social risk are assessed as modifiers of treatment effectiveness .\
METHODS	We hypothesize that CPP will be at least as effective as PCIT for reducing child behavior problems and improving parenting but the programs will differ on cost and their social validity as perceived by parents and clinicians .\
CONCLUSIONS	This is the first study to compare the effectiveness of a PT program originally designed with and for parents from underserved racial and ethnic populations ( CPP ) against a well-established program considered to be the ` the gold standard ' ( PCIT ) with a high-risk population of parents .\
CONCLUSIONS	Challenges related to conducting a randomized trial in a fee-for-service mental health clinic serving urban , low-income families are discussed .\
BACKGROUND	NCT01517867 .\
\
###10968690\
BACKGROUND	End-stage renal disease and the need for chronic hemodialysis is an indication for hepatitis B vaccination , but up to half of dialysis patients fail to respond to a 40 microg/dose i.m. three-dose primary series of recombinant hepatitis B vaccine .\
BACKGROUND	Only another 10-20 % respond to additional boosting doses of vaccine .\
METHODS	Since GM-CSF has been shown to be an effective adjuvant for hepatitis B vaccine in healthy subjects and multiple animal vaccine models , we conducted a randomized , double-blind trial of GM-CSF with recombinant hepatitis B vaccine in chronic hemodialysis patients .\
METHODS	Patients with negative hepatitis B surface antibody and antigen who had received at least three doses of recombinant hepatitis B vaccine without response ( antibody titre < 10 mIU/ml ) were randomized to placebo , 40 microg , or 80 microg of GM-CSF given with 40 microg recombinant hepatitis B vaccine i.m. at the same site .\
METHODS	Clinical and laboratory studies for safety assessment were done on days 1 and 3 , and hepatitis B surface antibody titres were measured at baseline and days 21 and 180 after the study injections .\
RESULTS	No significant local or systemic toxicity was noted from the co-injections .\
RESULTS	The rates of response and geometric mean titre ( GMT ) were equivalent among all three study groups : placebo 6/10 developed antibodies , GMT 22.1 mIU/ml ; 40 microg GM-CSF 3/10 developed antibodies , GMT 5.4 mIU ; and 80 microg GM-CSF 3/8 developed antibodies , GMT 9.7 mIU/ml .\
RESULTS	Six months after vaccination , antibody titres were available for 11 of the 12 day 21 positive responders ; only 4 of these 11 patients remained antibody positive at 6 months .\
CONCLUSIONS	GM-CSF given in a single 40 microg and 80 microg i.m. dose was not an effective adjuvant with hepatitis B vaccine in chronic hemodialysis patients who had previously failed to respond to hepatitis B immunization .\
\
###20714145\
BACKGROUND	Biapenem is an injectable carbapenem antibiotic .\
BACKGROUND	A clinical study was designed to evaluate its efficacy and safety in the treatment of respiratory and urinary infections compared to imipenem/cilastatin .\
METHODS	A total of 216 patients with respiratory or urinary tract infections were enrolled into this multicenter , open-label , randomized controlled clinical study .\
METHODS	Each patient was randomly assigned to either the treatment or control group ; 106 patients in each group were included in the ITT analyses .\
METHODS	The patients were given biapenem 300 mg or imipenem/cilastatin 500 mg/500 mg two or three times daily , i.v. g.t.t. for 7-14 days according to their conditions .\
RESULTS	The cure and effective rates were 67.92 and 88.68 % in the biapenem group and 76.02 and 93.40 % in the imipenem/cilastatin group , the bacterial eradication rates were 93.83 and 98.82 % , and the adverse-event rates were 6.54 and 7.41 % , respectively .\
RESULTS	There were no significant differences between the two groups ( p > 0.05 ) .\
CONCLUSIONS	Biapenem is as effective and well-tolerated as imipenem/cilastatin for the treatment of intermediate and severe bacterial infections .\
\
###25381560\
BACKGROUND	The incidence of cardiovascular disease ( CVD ) in rheumatoid arthritis ( RA ) is increased compared to the general population .\
BACKGROUND	Immune dysregulation and systemic inflammation are thought to be associated with this increased risk .\
BACKGROUND	Early diagnosis with immediate treatment and tight control of RA forms a central treatment paradigm .\
BACKGROUND	It remains unclear , however , whether using tumor necrosis factor inhibitors ( TNFi ) to achieve remission confer additional beneficial effects over standard therapy , especially on the development of CVD .\
METHODS	Coronary Artery Disease Evaluation in Rheumatoid Arthritis ( CADERA ) is a prospective cardiovascular imaging study that bolts onto an existing single-centre , randomized controlled trial , VEDERA ( Very Early versus Delayed Etanercept in Rheumatoid Arthritis ) .\
METHODS	VEDERA will recruit 120 patients with early , treatment-nave RA , randomized to TNFi therapy etanercept ( ETN ) combined with methotrexate ( MTX ) , or therapy with MTX with or without additional synthetic disease modifying anti-rheumatic drugs with escalation to ETN following a ` treat-to-target ' regimen .\
METHODS	VEDERA patients will be recruited into CADERA and undergo cardiac magnetic resonance ( CMR ) assessment with ; cine imaging , rest/stress adenosine perfusion , tissue-tagging , aortic distensibility , T1 mapping and late gadolinium imaging .\
METHODS	Primary objectives are to detect the prevalence and change of cardiovascular abnormalities by CMR between TNFi and standard therapy over a 12-month period .\
METHODS	All patients will enter an inflammatory arthritis registry for long-term follow-up .\
CONCLUSIONS	CADERA is a multi-parametric study describing cardiovascular abnormalities in early , treatment-nave RA patients , with assessment of changes at one year between early biological therapy and conventional therapy .\
BACKGROUND	This trial was registered with Current Controlled Trials ( registration number : ISRCTN50167738 ) on 8 November 2013 .\
\
###18558169\
BACKGROUND	Appendicitis is the most common emergency condition in children .\
BACKGROUND	Historically , a 3-drug regimen consisting of ampicillin , gentamicin , and clindamycin ( AGC ) has been used postoperatively for perforated appendicitis .\
BACKGROUND	A retrospective review at our institution has found single day dosing of ceftriaxone and metronidazole ( CM ) to be a more simple and cost-effective antibiotic strategy .\
BACKGROUND	Therefore , we performed a prospective , randomized trial to compare efficacy and cost-effectiveness of these 2 regimens .\
METHODS	After internal review board approval ( IRB no. 04 12-149 ) , children found to have perforated appendicitis at appendectomy were randomized to either once daily dosing of CM ( 2 total doses per day ) or standard dosing of AGC ( 11 total doses per day ) .\
METHODS	Perforation was defined as an identifiable hole in the appendix .\
METHODS	The operative approach ( laparoscopic ) , length of antibiotic use , and criteria for discharge were standardized for the groups .\
METHODS	Based on our retrospective analysis using length of postoperative hospitalization as a primary end point , a sample size of 100 patients was calculated for an alpha of .5 and a power of 0.82 .\
RESULTS	One hundred patients underwent laparoscopic appendectomy for perforated appendicitis .\
RESULTS	On presentation , there were no differences in sex distribution , days of symptoms , temperature , or leukocyte count .\
RESULTS	There was no difference in abscess rate or wound infections between groups .\
RESULTS	The CM group resulted in significantly less antibiotic charges then the AGC group .\
CONCLUSIONS	Once daily dosing with the 2-drug regimen ( CM ) offers a more efficient , cost-effective antibiotic management in children with perforated appendicitis without compromising infection control when compared to a traditional 3-drug regimen .\
\
###12092994\
OBJECTIVE	To compare the safety and efficacy with respect to the control of calculus and stain of two power toothbrushes .\
METHODS	This was a cross-over study involving a total of 81 subjects from a general population who used , in a randomized sequence , the Braun Oral-B 3D Excel ( D17 ) and the Sonicare toothbrush with a conventional dentifrice , and a manual brush with a tartar control dentifrice .\
METHODS	The manual toothbrush with tartar control dentifrice served as a positive control with respect to control of calculus .\
METHODS	Following 9 weeks of manual brush use with a conventional , non-abrasive dentifrice , each test brush was used for a period of 9 weeks , after which subjects switched to the next brush in the sequence .\
METHODS	Calculus was scored using the Volpe-Manhold Calculus Index and stain using the Lobene Stain Index .\
RESULTS	All three brushes were found to be safe as used in the study .\
RESULTS	All three toothbrushes significantly reduced the levels of calculus as compared to the control period .\
RESULTS	Reduction from baseline in the rate of calculus formation was greatest in the D17 group ( 63 % ) , followed by the manual brush with tartar control dentifrice ( 60 % ) and Sonicare ( 44 % ) .\
RESULTS	Both the D17 and the manual brush were significantly more effective than Sonicare ( P < 0.001 ) .\
RESULTS	The D17 was also more effective at controlling stain formation than either Sonicare or the manual brush with tartar control dentifrice at the gingival margin , the difference from Sonicare being statistically significant for all analyses ( P < 0.0001 ) .\
RESULTS	It is concluded that the D17 is significantly more effective in reducing both the rate of calculus and stain formation than the Sonicare toothbrush .\
\
###19089501\
OBJECTIVE	We evaluated the association between physicians ' communication behavior and breast cancer patients ' trust in their physicians .\
METHODS	Longitudinal survey conducted at baseline , 2-month , and 5-month follow-up during first year of diagnosis .\
METHODS	Newly diagnosed breast cancer patients ( N = 246 ) .\
METHODS	We collected data on patient perceptions of the helpfulness of informational , emotional , and decision-making support provided by physicians and patients ' trust .\
METHODS	Linear regression models evaluated the association of concurrent and prior levels of physician support with patients ' trust .\
RESULTS	At baseline , patients who received helpful informational , emotional , and decision-making support from physicians reported greater trust ( p < 0.05 , p < 0.001 , and p < 0.01 , respectively ) .\
RESULTS	At the 2-month assessment , baseline informational support and informational and emotional support at 2-months were associated with greater trust ( p < 0.05 , p < 0.01 , and p < 0.05 , respectively ) .\
RESULTS	At the 5-month assessment , only helpful emotional support from physicians at 5 months was associated with greater trust ( p < 0.01 ) .\
RESULTS	Interestingly , while perceived helpfulness of all three types of physician support decreased significantly over time , patient trust remained high and unchanged .\
CONCLUSIONS	Findings suggest that while informational and decision-making support may be more important to patient trust early in the course of treatment , emotional support from physicians may be important to maintain trust throughout the initial year of diagnosis .\
\
###10335722\
OBJECTIVE	To compare the efficacy and tolerability of oral risedronate and etidronate for treatment of Paget 's disease of bone .\
METHODS	Patients from 12 centers in North America received risedronate 30 mg daily for 2 months ( 62 patients ) or etidronate 400 mg daily for 6 months ( 61 patients ) in a prospective , randomized , double-blind study .\
METHODS	Serum alkaline phosphatase ( the primary variable ) , serum bone-specific alkaline phosphatase , and urinary deoxypyridinoline concentrations were monitored for 12 to 18 months .\
RESULTS	Serum alkaline phosphatase concentration normalized by month 12 in 73 % of risedronate-treated patients , compared with 15 % of those receiving etidronate ( P < 0.001 ) .\
RESULTS	Median time to normalization was 91 days for risedronate-treated patients and > 360 days for etidronate-treated patients ( P < 0.001 ) ; relapse rates were 3 % in the risedronate group and 15 % in the etidronate group ( P < 0.05 ) .\
RESULTS	At month 18 , 53 % of the risedronate group and 14 % of the etidronate group remained in biochemical remission .\
RESULTS	Urinary deoxypyridinoline normalized in 87 % of patients on risedronate and 57 % of patients receiving etidronate ( P < 0.01 ) ; serum bone-specific alkaline phosphatase normalized in 73 % of patients on risedronate and 18 % of patients on etidronate ( P < 0.001 ) .\
RESULTS	Patients who had received etidronate previously had a blunted response to etidronate , but not to risedronate .\
RESULTS	Reductions in pain were statistically significant in the risedronate group , but not in the etidronate group .\
RESULTS	Both drugs were well tolerated .\
CONCLUSIONS	Although etidronate is effective , risedronate offers a shorter duration of therapy , better and longer-lasting remission , significant reductions in pain , and provides additional remission in subjects who exhibited an incomplete response to previous etidronate treatment .\
\
###10735426\
OBJECTIVE	To evaluate the utility of low-dose irradiation as adjunctive treatment for failing dialysis shunts related to stenoses .\
METHODS	Thirty-one patients with 41 lesions in their dialysis shunts were successfully enrolled for this study .\
METHODS	After imaging of the shunt and calculation of venous stenoses , each patient was randomized into one of two segments of the protocol : ( i ) angioplasty and/or stent placement alone , and ( ii ) angioplasty and/or stent placement followed by external beam irradiation .\
METHODS	All patients with significant venous stenoses ( > or = 50 % ) were treated with appropriately sized PTA ( percutaneous transluminal angioplasty ) and Wallstents .\
METHODS	Patients randomized to the external irradiation segment underwent localized irradiation via a Theratron cobalt unit of 7 Gy 0-24 hours and 24-48 hours after intervention .\
METHODS	Those patients randomized to the control group received no additional treatment .\
METHODS	Clinical follow-up included resumption of successful dialysis with appropriate hemodynamic parameters .\
METHODS	Two follow-up shunt images were obtained , follow-up 1 ( fu-1 ) from 90 to 179 days and follow-up 2 ( fu-2 ) from 180 to 365 days .\
METHODS	Percentages of significant recurrent stenoses , defined as greater than 50 % , were recorded and re-treated as needed .\
RESULTS	Sixteen of the 31 patients underwent external beam irradiation .\
RESULTS	There were 21 lesions in the test group that underwent irradiation after intervention , and 20 lesions were treated with intervention alone .\
RESULTS	There were seven native arteriovenous fistulas and 24 Gore-tex grafts .\
RESULTS	All stenoses were either venous outflow stenoses ( 68 % ) or central stenoses ( 32 % ) .\
RESULTS	The authors utilized chi2 analysis to compare restenoses rates between the control and irradiated groups at fu-1 ( P < .99 ) and fu-2 ( P < .10 ) .\
CONCLUSIONS	Although the results show that external beam irradiation has minimal effects on the restenoses of dialysis grafts when used in conjunction with PTA and stent placement , further studies with a larger , more homogenous population are needed to assess the trend of improving patency rates after external beam irradiation .\
\
###22122738\
BACKGROUND	Fractional laser therapy ( FLT ) has become a widely accepted modality for skin rejuvenation and has also been used in various other skin diseases .\
OBJECTIVE	To observe long-term histologic effects of nonablative and ablative FLT in the treatment of pigment disorders .\
METHODS	A randomized controlled observer-blinded study was performed in 18 patients with pigment disorders .\
METHODS	Two similar test regions were randomized to receive FLT with intermittent topical bleaching or topical bleaching alone .\
METHODS	Patients with ashy dermatosis ( AD ) and postinflammatory hyperpigmentation ( PIH ) were treated using nonablative 1,550-nm FLT ( 15mJ/microbeam , 14-20 % coverage ) , whereas patients with Becker 's nevus ( BN ) were treated with ablative 10,600-nm FLT ( 10mJ/microbeam , 35-45 % coverage ) for three to five sessions .\
METHODS	Biopsies were obtained 3months after the last treatment .\
RESULTS	At follow-up , dermal fibrosis was observed in four of eight patients treated using ablative FLT and no patients treated using nonablative FLT ( p < .05 ) .\
CONCLUSIONS	Assuming that the dermal response is comparable in AD , PIH , and BN , at the given settings , ablative FLT may induce fibrosis , whereas treatment with nonablative FLT does not .\
CONCLUSIONS	Whether formation of fibrosis has to be regarded as dermal remodeling or a subtle subclinical form of scarring should be investigated in future research .\
\
###16996583\
OBJECTIVE	Concurrent chemoradiation is the standard treatment for locally advanced cervical cancer .\
OBJECTIVE	This study was a preliminary result of a randomized two arms , prospective , open-label phase III trial comparing the activity and safety of the concurrent chemoradiation of Tegafur-Uracil and carboplatin or carboplatin alone in locally advanced cervical cancer .\
METHODS	The stage IIB-IIIB cervical cancer patients were randomized to have Tegafur-Uracil 225 mg/m ( 2 ) / day orally , 5 days a week and carboplatin 100 mg/m ( 2 ) IV over 30-60 min , weekly on day 1 concurrent with standard radiotherapy ( Group A ) or carboplatin alone concurrent with standard radiotherapy ( Group B ) .\
RESULTS	Four hundred and sixty-nine patients were randomized to Group A ( n = 234 ) or Group B ( n = 235 ) .\
RESULTS	The tumor response at 3-month follow-up time showed no significant difference .\
RESULTS	The only prognostic factor to improve the complete response rate was the hemoglobin level .\
RESULTS	The patients in Group A , who had Hb < 10 gm/dL had the relatively better change to complete response of 1.48 compared to that in Group B ( P 0.025 , 95 % CI 1.07 , 2.04 ) .\
RESULTS	No severe toxicity or adverse event had been reported .\
RESULTS	The median follow-up time for Group A and Group B was 12.6 and 11.8 months , respectively .\
RESULTS	There was no statistical difference in PFS and OS .\
CONCLUSIONS	Concurrent chemoradiation by Tegafur-Uracil and carboplatin showed no difference in tumor response rate or treatment toxicity compared to carboplatin alone .\
CONCLUSIONS	The combination drugs might have benefit in poor prognostic patients such as the baseline Hb < 10 gm/dL .\
\
###16205905\
OBJECTIVE	Clonidine applied intra-articularly into the knee joint has a peripheral analgesic effect .\
OBJECTIVE	We examined intra-articularly injected clonidine to determine whether resorption with a measurable systemic concentration could be detected .\
METHODS	A randomised , placebo-controlled double-blind study was carried out on patients undergoing knee arthroscopies .\
METHODS	The 69 patients were randomised into three groups : group 1 received 150 ug clonidine intra-articularly , group two 150 ug clonidine intravenously and group three a placebo .\
METHODS	Postoperative pain therapy was carried out with i.v. morphine hydrochloride .\
METHODS	Pain scores and side-effects were documented for 24 h.\
RESULTS	There were no significant differences between the three groups in demographics , duration of operation , duration of anaesthesia , diagnoses or type of operation .\
RESULTS	The pain score at rest was significantly lower in group 1 .\
RESULTS	In the first 20 min , the systemic concentration of clonidine was significantly higher in the intravenous group than in the intra-articular group .\
CONCLUSIONS	Intra-articular clonidine has a postoperative analgesic effect after knee arthroscopies due to a peripheral action .\
\
###15541982\
OBJECTIVE	Postoperative air leakage is the most frequent complication after pulmonary surgery .\
OBJECTIVE	The development of modern surgical techniques has been influenced strongly by the need to manage air leakage effectively during pulmonary resection .\
OBJECTIVE	This study evaluated the effect of using an autologous fibrin sealant ( Vivostat ) during lobectomy on morbidity following surgery .\
METHODS	This was a prospective , blinded , randomised clinical study .\
METHODS	Patients undergoing lobectomy were enrolled into two groups ( Vivostat or non-treatment control , 20 per group ) .\
METHODS	Air leakage was measured over a 1-h period ( using a mechanical suction pump ) on the day of operation , and both air leakage and bleeding/exudation ( drainage volume ) were recorded every morning postoperatively until the chest tubes were removed .\
METHODS	Personnel recording these parameters were blinded to the intervention received .\
RESULTS	Compared with the control group , mean bleeding/exudate volumes were significantly reduced in the Vivostat group ( day 1,370 vs. 525 ml ; total , 424 vs. 782 ml ; both P < 0.001 ) , and drains were inserted for a shorter time ( medians , 1 vs. 2 days , P = 0.07 ) .\
RESULTS	Significantly fewer patients had air leakage at any time in the Vivostat group ( 40 vs. 80 % , P = 0.02 ) , and air leakage volumes were significantly lower compared with the control group ( median differences : day of surgery : 0.6 l/min , P = 0.01 ; total 0.8 l/min , P = 0.03 ) .\
RESULTS	Postoperative hospitalisation time was shorter in the Vivostat group than in the control group but the difference was not significant ( 0.5 days , P = 0.12 ) .\
CONCLUSIONS	Vivostat fibrin sealant significantly reduces post-surgical air leakage and drainage volumes following lobectomy in pulmonary surgery and is suitable for routine use in this procedure .\
\
###20004065\
BACKGROUND	Nicotine replacement therapies are efficacious for treating nicotine dependence .\
BACKGROUND	However , limited data exist on benefits of different NRTs and predictors of treatment outcome .\
BACKGROUND	This study compared the effectiveness of transdermal nicotine vs. nicotine lozenge for smoking cessation and identified predictors of treatment response .\
METHODS	A randomized , open-label effectiveness trial was conducted at 12 medical sites participating in the National Cancer Institute 's Community Clinical Oncology Program .\
METHODS	The sample consisted of 642 treatment-seeking smokers randomized to 12 weeks of transdermal nicotine or nicotine lozenge .\
RESULTS	Smoker characteristics were assessed at baseline , and 24-h point prevalence abstinence confirmed with breath carbon monoxide ( CO ) was evaluated at end of treatment ( EOT ) and at a 6-month follow-up .\
RESULTS	There was a trend for higher quit rates for transdermal nicotine vs. nicotine lozenge at EOT ( 24.3 % vs. 18.7 % , p = .10 ) and 6 months ( 15.6 % vs. 10.9 % , p = .10 ) .\
RESULTS	A logistic regression model of EOT quit rates showed smokers who preferred transdermal nicotine , were not reactive to smoking cues , and did not use nicotine to alleviate distress or stimulate cognitive function had higher quit rates on transdermal nicotine .\
RESULTS	A logistic regression model of 6-month quit rates showed smokers who preferred transdermal nicotine had higher quit rates on transdermal nicotine , and smokers who used nicotine to alleviate distress or stimulate cognitive processes had lower quit rates on nicotine lozenge .\
CONCLUSIONS	Transdermal nicotine may be more effective than nicotine lozenge for smokers who prefer transdermal nicotine and do not smoke to alleviate emotional distress or stimulate cognitive function .\
\
###16306032\
OBJECTIVE	As part of the large international , randomized 2NN trial , the pharmacokinetics of nevirapine in once-daily 400 mg and twice-daily 200 mg dosing regimens were investigated .\
METHODS	Treatment-naive HIV-1-infected patients were randomized to receive nevirapine 400 mg once daily or 200 mg twice daily , in combination with lamivudine and stavudine .\
METHODS	Blood samples were collected at several time-points ( day 3 , weeks 1 , 2 , 4 , 24 , and 48 ) .\
METHODS	Differences in pharmacokinetics between once - versus twice-daily dosing were investigated with nonlinear mixed effects modelling ( NONMEM ) .\
RESULTS	In total , 2,899 nevirapine plasma concentrations were available from 578 patients .\
RESULTS	Dosage and dosing frequency did not influence clearance or volume of distribution of nevirapine , indicating linear pharmacokinetic behavior of nevirapine whether given as a single daily dose or as divided doses over 24 hours .\
RESULTS	During steady state , the Cmin was lower ( 3.26 mg/L vs. 4.44 mg/L ; p < .001 ) and the Cmax was higher ( 7.88 mg/L vs. 6.55 mg/L ; p < .001 ) in the once-daily arm .\
RESULTS	However , compared to total variability in nevirapine levels for both treatments , these differences were minor .\
RESULTS	During steady state , total exposure , measured as AUC24h , was comparable for both regimens ( 133 mg/L * h vs. 133 mg/L * h ; p = .084 ) .\
CONCLUSIONS	The daily exposure to nevirapine ( AUC24h ) was similar for the 400 mg once-daily and the 200 mg twice-daily dosing regimens .\
CONCLUSIONS	The Cmin of nevirapine is lower and the Cmax of nevirapine is higher for the once-daily regimen as compared to the twice-daily regimen .\
CONCLUSIONS	As a result , 200 mg nevirapine dosed twice daily may be preferred over 400 mg nevirapine dosed once daily .\
\
###21372744\
OBJECTIVE	A randomized controlled trial was undertaken to determine the impact of a 12-month exercise program on the temporal characteristics of the foot rollover during walking , based on plantar pressure data .\
METHODS	One hundred twenty one postmenopausal women aged 41 to 77 years comprised the sample and were randomly recruited from the community .\
METHODS	Exercise and control women were tested before and at the end of the trial .\
METHODS	The temporal characteristics were assessed with the women walking barefoot at a self-selected speed over a 9-meter-long walking track having a built-in pressure platform .\
METHODS	The initial and final contacts at the lateral and medial heel , metatarsal heads I to V , and the hallux ( medial and lateral ) were measured .\
RESULTS	Women from the exercise group presented a latter time of making contact in the relative metatarsal 4 , metatarsal 5 ( absolute and relative ) , and medial heel ( absolute and relative ) and earlier relative initial contact in toe 1 .\
RESULTS	In the modification rates , postmenopausal women from the exercise group presented ( 1 ) latter final contact ( absolute and relative ) in metatarsal 5 , ( 2 ) latter relative final contact in metatarsal 4 , and ( 3 ) earlier relative initial contact in toe 1 .\
RESULTS	Postmenopausal women from the control group presented an earlier initial contact in metatarsal 3 ( absolute and relative ) .\
RESULTS	Repeated-measures analysis of variance demonstrated a time effect in most variables considered .\
CONCLUSIONS	The exercise program is effective in improving the gait pattern in postmenopausal women who adhere , and time has the main effect .\
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###17711168\
BACKGROUND	Urinary incontinence is a frequent condition in women ; it is estimated that it affects between 10 % and 30 % of women .\
BACKGROUND	The most common types are stress , urgency and mixed incontinence .\
BACKGROUND	It is a fact that this condition affects their quality of life .\
OBJECTIVE	To assess the benefits of applying an integrated and standardized nursing intervention on women with a slight or moderate degree of stress , urge or mixed urinary incontinence .\
METHODS	Randomized , controlled clinical trial .\
METHODS	Area 6 of primary care in Madrid .\
METHODS	256 women , 128 per group .\
METHODS	Systematized care plan for the intervention group ( IG ) and conventional plan for the control group ( CG ) , depending on urinary incontinence type .\
RESULTS	59 % of the total sample participated ; 103 participants were followed : 48 from the IG ( 37.5 % ) and 55 from the CG ( 42.9 % ) .\
RESULTS	The average difference in urine loss before and after intervention was 5.7 g ( n = 22 ) for the IG , as opposed to 1.8 g ( n = 27 ) for the CG ; this reduction was not significant ( p = 0.12 ) , 95 % CI [ -1.09 - 8.92 ] .\
RESULTS	IU degree changes were assed by means of the Sandvik scale and were grouped in `` women that improved or cured '' and `` women that remained the same or got worse '' after interention .\
RESULTS	40.5 % of the women in the IG improved or cured , as opposed to 21 % of the women in the CG ( p = 0.059 ) .\
CONCLUSIONS	both care plans showed their efficiency to improve UI in this group of women .\
CONCLUSIONS	The mentioned improvement was greater in the IG than in the CG , with clinically relevant differences .\
CONCLUSIONS	The fact that some of the women gave up the project during the follow-up determined a power reduction of the study .\
\
###15158296\
BACKGROUND	The intake of 10 g/day of short-chain-fructo-oligosaccharides ( sc-FOS ) has been shown to increase significantly bifidus counts and to produce high amounts of short-chain fatty acids ( SCFA ) , presumed to influence glucose and lipid metabolism .\
OBJECTIVE	To evaluate the effects of moderate intake of sc-FOS on glucose and lipid metabolism in individuals with mild hypercholesterolaemia .\
METHODS	A randomized double-blind sequential cross-over study .\
METHODS	Thirty subjects of both genders ( 20 M/10 F ) , mean age 45.5 + / -9.9 years ( M + / - SD ) , BMI 26.6 + / -2.2 kg/m ( 2 ) , with plasma cholesterol > 5.17 and < 7.76 mmol/l and plasma triglycerides < 3.45 mmol/l , participated in the study .\
METHODS	The study was performed after a wash-out period of 1 month and a run-in period of 1 month to stabilize patients on a standard diet ( CHO 50 % , fat 30 % , protein 20 % , fibre 20 g/day ) plus placebo ( maltodextrine plus aspartame 15 g/day ) .\
METHODS	At the end of run-in , subjects were randomly assigned to receive sc-FOS ( Actilight ) ( 10.6 g/day ) or placebo ( maltodextrine plus aspartame 15 g/day ) with tea and/or coffee for a duration of 2 months and thereafter switched to the other treatment for additional 2 months .\
METHODS	Plasma glucose , total and lipoprotein ( VLDL , LDL , HDL ) cholesterol and triglyceride concentrations were measured in the fasting state at the end of run-in and of each treatment period .\
METHODS	At the end of the two treatment periods , patients consumed a standard test meal ( protein 15 % , carbohydrate 34 % , fat 51 % , kJ 3988 ) 1h after the administration of 5.3 g of sc-FOS or placebo ; plasma glucose , insulin , free fatty acid ( FFA ) and triglyceride responses to the test meal were evaluated .\
RESULTS	No significant difference in fasting parameters was detected between the two treatments .\
RESULTS	After sc-FOS and placebo plasma cholesterol levels were , respectively , 6.47 + / -0.70 and 6.44 + / -0.78 mmol/l ( n.s. ) and plasma triglycerides were 1.53 + / -0.71 and 1.56 + / -0.53 mmol/l ( n.s. ) .\
RESULTS	No significant differences were observed in cholesterol and triglyceride content of VLDL , LDL and HDL and in plasma Apo A1 levels ; conversely , fasting plasma Lp ( a ) concentrations were significantly increased after sc-FOS ( 37 + / -38 vs. 33 + / -35 mg/dl ; P < 0.005 ) .\
RESULTS	Postprandial responses of glucose , FFA and triglycerides were not significantly different between sc-FOS and placebo , while postprandial insulin response ( incremental area ) was significantly reduced after sc-FOS compared to placebo ( 14,490 + / -7416 vs. 17,760 + / -7710 pmol/l x 300 min ; P < 0.02 ) .\
CONCLUSIONS	A moderate intake of sc-FOS has no major effects on lipid metabolism , both in the fasting and in the postprandial period , in individuals with mild hypercholesterolaemia .\
CONCLUSIONS	A small but significant increase of Lp ( a ) concentrations was observed with sc-FOS consumption together with a reduction of the postprandial insulin response ; however , the clinical relevance of these small effects is unclear .\
\
###11273473\
OBJECTIVE	To assess the efficacy and safety of doxycycline as a disease modifying anti-rheumatic drug ( DMARD ) in rheumatoid arthritis ( RA ) and compare it with methotrexate , a standard DMARD .\
METHODS	A single ( assessor ) blind prospective study with 15 patients of RA randomized to doxycycline and 14 to methotrexate .\
METHODS	Baseline disease characteristics were similar in both groups .\
RESULTS	All disease activity measures studied viz .\
RESULTS	tender and swollen joint counts , physician and patient global assessment , visual analogue pain scale , health assessment questionnaire and ESR improved in both the treatment groups after six months of treatment .\
RESULTS	The difference between doxycycline and methotrexate was not statistically significant .\
RESULTS	No major side effects necessitating drug withdrawal were reported from either group .\
RESULTS	The side effects were few and mostly gastrointestinal .\
CONCLUSIONS	Doxycycline is a safe disease modifying drug in RA whose effect is sustained at six months .\
CONCLUSIONS	It compared favourably with methotrexate over a six month follow up .\
\
###19903804\
BACKGROUND	Human papillomavirus ( HPV ) DNA testing has shown higher sensitivity than cytology for detecting cervical lesions , but it is uncertain whether the higher sensitivity is dependent on the age of the woman being screened .\
BACKGROUND	We compared the age-specific performance of primary HPV DNA screening with that of conventional cytology screening in the setting of an organized population-based cervical cancer screening program in Finland .\
METHODS	From January 1 , 2003 , to December 31 , 2005 , randomized invitations were sent to women aged 25-65 years for routine cervical cancer screening by primary high-risk HPV DNA testing ( n = 54 207 ) with a Hybrid Capture 2 assay followed by cytology triage for women who were HPV DNA positive or by conventional cytology screening ( n = 54 218 ) .\
METHODS	In both screening arms , cytology results of low-grade squamous intraepithelial lesion or worse triggered a referral for colposcopy .\
METHODS	Relative rates ( RRs ) of detection to assess test sensitivity , specificity , and positive predictive values ( PPVs ) with 95 % confidence intervals ( CIs ) were calculated for the histological endpoints of cervical intraepithelial neoplasia ( CIN ) grade 1 or higher ( CIN 1 + ) , CIN grade 2 or higher ( CIN 2 + ) , and CIN grade 3 or higher ( CIN 3 + ) .\
METHODS	All statistical tests were two-sided .\
RESULTS	The overall frequency of colposcopy referrals was 1.2 % in both screening arms .\
RESULTS	Women younger than 35 years were referred more often in the HPV DNA screening vs the conventional screening arm ( RR = 1.27 , 95 % CI = 1.01 to 1.60 ) .\
RESULTS	The prevalence of histologically confirmed CIN or cancer was 0.59 % in the HPV DNA screening arm vs 0.43 % in the conventional screening arm .\
RESULTS	The relative rates of detection for CIN 1 , CIN 2 , and CIN 3 + for HPV DNA screening with cytology triage vs conventional screening were 1.44 ( 95 % CI = 0.99 to 2.10 ) , 1.39 ( 95 % CI = 1.03 to 1.88 ) , and 1.22 ( 95 % CI = 0.78 to 1.92 ) , respectively .\
RESULTS	The specificity of the HPV DNA test with cytology triage was equal to that of conventional screening for all age groups ( 99.2 % vs 99.1 % for CIN 2 + , P = .13 ) .\
RESULTS	Among women aged 35 years or older , the HPV DNA test with cytology triage tended to have higher specificity than conventional screening .\
RESULTS	The PPVs for HPV DNA screening with cytology triage were consistently higher than those for conventional screening .\
RESULTS	In both screening arms , the test specificities increased with increasing age of the women being screening , whereas the highest PPVs were observed among the youngest women being screened .\
RESULTS	Overall , 7.2 % of women in the HPV DNA screening arm vs 6.6 % of women in the conventional screening arm were recommended for intensified follow-up , and the percentages were highest among 25 - to 29-year-olds ( 21.9 % vs 10.0 % , respectively ) .\
CONCLUSIONS	Primary HPV DNA screening with cytology triage is more sensitive than conventional screening .\
CONCLUSIONS	Among women aged 35 years or older , primary HPV DNA screening with cytology triage is also more specific than conventional screening and decreases colposcopy referrals and follow-up tests .\
\
###15971825\
OBJECTIVE	To quantify absorption of colostral IgG by healthy neonatal foals and to test the hypothesis that delayed ingestion of macromolecules prolongs the duration of intestinal permeability to immunoglobulins ( Ig ) in newborn foals .\
METHODS	Thirteen mixed breed foals .\
METHODS	Foals were randomly assigned to two treatment groups , which were fed either a glucose-electrolyte solution or a commercial milk replacer for 12 h after birth , before being fed a known amount of colostral IgG .\
METHODS	A control group was fed a known amount of colostral IgG from birth .\
METHODS	The efficiency of IgG absorption was calculated following determination of plasma IgG concentration for each foal .\
RESULTS	Foals given colostrum immediately after birth transferred approximately 51 % of ingested IgG into their vascular space .\
RESULTS	Delayed colostral ingestion significantly reduced the amount of IgG absorbed by foals .\
RESULTS	Withholding macromolecules for 12 h had no effect on the subsequent efficiency of IgG absorption .\
CONCLUSIONS	Colostrum should be supplied to foals within 12 h of birth for best uptake of Ig .\
CONCLUSIONS	The type of fluid administered to foals before the ingestion of colostrum does not influence subsequent absorption of Ig , suggesting that the process of gut closure in foals is not mediated by a finite capacity for macromolecular uptake .\
\
###22803426\
OBJECTIVE	To study the regulatory effect of Ligustrazine Injection ( LI ) on the cellular immune function in patients undergoing autologous blood transfusion ( ABT ) .\
METHODS	Enrolled were 60 patients scheduled for receiving selective lumbar surgery at the Department of Spinal Orthopedics , First Hospital Affiliated to Guangzhou University of Traditional Chinese Medicine during October 2009 to June 2010 .\
METHODS	They were equally randomized into two groups , the trial group and the control group .\
METHODS	LI was given to patients in the trial group by intravenous dripping at the dose of 2 mg/kg 30 min before autologous blood collection .\
METHODS	The LI ( at the final concentration of 0.005 % ) was added in the heparin saline solution and the washing saline for recycle blood .\
METHODS	No LI was given to patients in the control group .\
METHODS	They received the same treatment of the trial group .\
METHODS	The operation time , the amount of blood loss and blood transfusion were recorded .\
METHODS	Patients ' venous blood samples were collected for determining cytokines including interleukin-2 ( IL-2 ) , interleukin-10 ( IL-10 ) , interferon-gamma ( IFN-gamma ) by ELISA and calculating IL-2 / IL-10 ratio before surgery ( T1 ) , 1 h ( T2 ) , 1 day ( T3 ) , and 5 days ( T4 ) after ABT .\
RESULTS	There was no statistical difference in the amount of blood loss and blood transfusion , the levels of IL-2 , IL-10 , IFN-gamma , or IL-2 / IL-10 at T1 between the two groups ( P > 0.05 ) .\
RESULTS	Compared with T1 of the same group , the level of IL-2 decreased at T ( 2-4 ) , IL-10 increased and IL-2 / IL-10 decreased at T ( 2-3 ) in the two groups .\
RESULTS	The level of IFN-gamma decreased at T ( 2-4 ) , IL-2 / IL-10 increased at T4 , the level of IL-10 decreased at T4 in the control group ( P < 0.05 , P < 0.01 ) .\
RESULTS	The level of IL-10 decreased at T4 in the trial group with statistical difference ( P < 0.05 , P < 0.01 ) .\
RESULTS	Compared with the control group , the level of IL-2 , IFN-gamma , and IL-2 / IL-10 at T ( 2-4 ) were obviously higher in the trial group .\
RESULTS	But the IL-10 level was lower in the trial group than in the control group at T ( 2-4 ) ( P < 0.05 , P < 0.01 ) .\
CONCLUSIONS	The application of LI in ABT had regulatory effects on the balance of cytokines .\
\
###17499999\
BACKGROUND	The pathogenesis of the post cardiopulmonary bypass ( CPB ) organ dysfunction syndrome is complex , with inflammation being an important component .\
BACKGROUND	The purpose of this prospective , randomized and controlled study was to evaluate the effect of a single dose of pentoxifylline ( PTX ) prior to CPB on high dependency unit time .\
METHODS	We studied 39 patients undergoing aorto-coronary bypass surgery with CPB .\
METHODS	Patients received either 5 mg kg ( -1 ) PTX after induction of anaesthesia or saline as placebo .\
METHODS	Haemodynamics , parameters of pulmonary function and plasma levels of tumour necrosis factor alpha ( TNFalpha ) and C-reactive protein ( CRP ) were measured after the induction of anaesthesia ( pre-CPB ) and after weaning from CPB ( post-CPB ) , 1 h after the admission to the intensive care unit ( ICU ) and on the morning of the first postoperative day ( 1 POD ) , respectively .\
METHODS	In addition , ventilation time and the high dependency unit time , i.e. the time till transferral to a peripheral ward , were documented .\
RESULTS	Patients in the PTX group had lower TNFalpha values ( 6.3 ng ml ( -1 ) ( 4/8 .2 ) vs 9.1 ng ml ( -1 ) ( 6.5 / 13.7 ) ) ( median ( 25 % / 75 % ) , p = 0.021 ) , lower systolic ( 28 + / -7 mm Hg vs 35 + / - 9 mm Hg , mean + / - SD , p = 0.011 ) and mean pulmonary artery pressures ( 21 + / -5 vs 26 + / -6 mm Hg , p = 0.017 ) after admission to the ICU than control patients .\
RESULTS	Haemodynamics and pulmonary function parameters did not differ .\
RESULTS	There was a trend towards earlier weaning from the respirator in the PTX group ( 10.0 + / -3.5 h ) ( min/max : 4/16 ; confidence interval ( ConF ) : 1.8 h ) than the control group ( 12.3 + / -4.2 h ) ( min/max : 5-24 ; ConI : 2.4 h ) ( p = 0.077 ) .\
RESULTS	Patients treated with PTX could be transferred to a peripheral ward about 24 h earlier than control patients ( 95 + / -35 h , min/max : 32/190 h ; ConI : 17 h ; 119 + / -29 h , min/max : 66/165 h ; ConI : 16 h ) respectively ; p = 0.037 ) .\
CONCLUSIONS	A single dose of PTX prior to CPB was able to reduce plasma levels of TNFalpha .\
CONCLUSIONS	In this descriptive study , there was a trend towards reduced duration of ventilation and the high dependency unit time , i.e. the time till transferral to a peripheral ward was shortened .\
\
###7487614\
OBJECTIVE	To determine the roles of immediate pars plana vitrectomy ( VIT ) and systemic antibiotic treatment in the management of postoperative endophthalmitis .\
METHODS	Investigator-initiated , multicenter , randomized clinical trial .\
METHODS	Private and university-based retina-vitreous practices .\
METHODS	A total of 420 patients who had clinical evidence of endophthalmitis within 6 weeks after cataract surgery or secondary intraocular lens implantation .\
METHODS	Random assignment according to a 2 x 2 factorial design to treatment with VIT or vitreous tap or biopsy ( TAP ) and to treatment with or without systemic antibiotics ( ceftazidime and amikacin ) .\
METHODS	A 9-month evaluation of visual acuity assessed by an Early Treatment Diabetic Retinopathy Study acuity chart and media clarity assessed both clinically and photographically .\
RESULTS	There was no difference in final visual acuity or media clarity with or without the use of systemic antibiotics .\
RESULTS	In patients whose initial visual acuity was hand motions or better , there was no difference in visual outcome whether or not an immediate VIT was performed .\
RESULTS	However , in the subgroup of patients with initial light perception-only vision , VIT produced a threefold increase in the frequency of achieving 20/40 or better acuity ( 33 % vs 11 % ) , approximately a twofold chance of achieving 20/100 or better acuity ( 56 % vs 30 % ) , and a 50 % decrease in the frequency of severe visual loss ( 20 % vs 47 % ) over TAP .\
RESULTS	In this group of patients , the difference between VIT and TAP was statistically significant ( P < .001 , log rank test for cumulative visual acuity scores ) over the entire range of vision .\
CONCLUSIONS	Omission of systemic antibiotic treatment can reduce toxic effects , costs , and length of hospital stay .\
CONCLUSIONS	Routine immediate VIT is not necessary in patients with better than light perception vision at presentation but is of substantial benefit for those who have light perception-only vision .\
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###21219106\
OBJECTIVE	The purpose of this study was to determine whether local analgesia at the incision site could reduce pain in women undergoing cesarean delivery or not .\
METHODS	One hundred and four women undergoing cesarean deliveries were randomized in two groups according to 10 ml of 2 % lidocaine ( n = 52 ) or 0.9 % saline ( n = 52 ) was injected at the abdominal incision prior to the performance of the cesarean section ( CS ) .\
METHODS	Postoperative pain treatment consisted of oral analgesia with mefenamic acid 500 mg .\
METHODS	Morphine 5 mg was used for rescue analgesia .\
METHODS	Pain intensity was self-evaluated with visual analog scale .\
METHODS	Data were analyzed by SPSS software version 11.5 and p value < 0.05 was considered significant .\
RESULTS	Women in lidocaine group perceived a significant reduction in postoperative pain in the first hours after surgery .\
RESULTS	There was also significantly less opioid analgesic requirement in the lidocaine than control group 4 h after CS ( 19 vs 44 women , p = 0.001 ) .\
RESULTS	No side effects were reported in either group .\
CONCLUSIONS	Preemptive analgesia with lidocaine infiltration at the incision is a simple and efficient mode with few side-effects that may reduce pain and opioid requirements in women undergoing CS .\
\
###20527340\
OBJECTIVE	Epidural volume extension ( EVE ) with saline solution can contribute to greater cephalad spread of drugs injected into the subarachnoid space during cesarean section .\
OBJECTIVE	We studied the incidence of material hypotension with spinal bupivacaine or levobupivacaine ( L-bupivacaine ) and the spread after epidural saline injection .\
METHODS	After ethics committee approval , we randomized women scheduled for cesarean section to 4 groups to receive 5 mg of 0.25 % bupivacaine with ( n = 51 ) or without ( n = 6 ) saline EVE ; 5 mg of 025 % L-bupivacaine ( n = 50 ) ; or 6 mg of 03 % L-bupivacaine ( n = 50 ) .\
METHODS	All patients also received 25 microg of fentanyl per 2 mL of local hyperbaric spinal anesthetic .\
METHODS	In all except the non-EVE group , 10 mL of saline was infused through an epidural catheter 5 minutes after anesthetic infusion .\
METHODS	We recorded patient demographic data , procedural and anesthetic times , incision-clamping times , occurrence of hypotension , ephedrine dose required , motor and sensory blockade , requirement for rescue analgesics , and neonatal outcome .\
RESULTS	After 6 patients had been randomized to the non-EVE group , no further patients were assigned because all the women required rescue analgesics .\
RESULTS	Demographic data , duration of procedure , time between .\
RESULTS	incision and delivery , and Apgar scores were similar in all the groups .\
RESULTS	The incidence of hypotension was lower in the group receiving 5 mg of L-bupivacaine ( 26 % vs. 52.9 % in the bupivacaine 5-mg group , and 56 % in the 6-mg L-bupivacaine group , P = .04 ) .\
RESULTS	More women given 5 mg of L-bupivacaine required rescue analgesia ( 46 % ) than did those receiving 5 mg of bupivacaine ( 235 % ) or 6 mg of L-bupivacaine ( 28 % ) ( P = .039 ) .\
RESULTS	Hypotension was associated with a lower umbilical cord pH ( P = .001 ) .\
RESULTS	Ephedrine doses over 20 mg were also associated with a lower umbilical cord pH ( P = .031 ) .\
CONCLUSIONS	The incidence of hypotension was lowest in the group anesthetized with 5 mg of L-bupivacaine , but the need for rescue analgesia was greater in this group .\
CONCLUSIONS	Doses of 5 mg and 6 mg may be sufficient for cesarean section , as they provide a good level of sensory blockade .\
\
###23398636\
OBJECTIVE	Postoperative oral nutritional supplementation is becoming a part of most patient care pathways .\
OBJECTIVE	This study examined the effects of low-volume high-calorie prescribed supplemental nutrition on patient outcome following elective colorectal surgery .\
METHODS	Patients undergoing elective colorectal resections were randomized to a prescribed nutritional supplementation group ( SG ) [ standard diet +660 ml/day of Pro-Cal ( 60ml = 200kcal +4 g protein ) ] or conventional postoperative diet group ( CG ) ( standard diet alone ) .\
METHODS	Preoperative and daily postoperative hand-grip strengths were measured using a grip dynamometer after randomization .\
METHODS	Daily food intake , return of bowel activity , nausea score for the first 3days and postoperative length of hospital stay ( LOS ) were prospectively recorded .\
METHODS	Micro-diet standardized software was used to analyse food diaries .\
METHODS	Nonparametric tests were used to analyse the data .\
RESULTS	Fifty-five patients were analysed ( SG 28 , CG 27 ) .\
RESULTS	There was no difference in median preoperative and postoperative handgrip strengths at discharge within each group ( SG 31.7 vs 31.7 kPa , P = 0.932 ; CG 28 vs 28.1 kPa , P = 0.374 ) .\
RESULTS	The total median daily calorie intake was higher in SG than CG ( SG 818.5 kcal vs CG 528kcal ; P = 0.002 ) .\
RESULTS	There was no difference in median number of days to first bowel movement ( SG 3days vs CG 4days , P = 0.096 ) .\
RESULTS	The median LOS was significantly shorter in SG than CG ( 6.5 vs 9days ; P = 0.037 ) .\
CONCLUSIONS	Prescribed postoperative high-calorie , low-volume oral supplements in addition to the normal dietary intake are associated with significantly better total daily oral calorie intake and may contribute to a reduced postoperative hospital stay .\
\
###21570027\
OBJECTIVE	To investigate whether intermittent catheterization ( IC ) with a hydrophilic-coated catheter delays the onset of the first symptomatic urinary tract infection ( UTI ) and reduces the number of symptomatic UTIs in patients with acute spinal cord injury ( SCI ) compared with IC with standard , uncoated catheters .\
METHODS	A prospective , randomized , parallel-group trial .\
METHODS	Fifteen North American SCI centers .\
METHODS	Participants were followed up while in the hospital or rehabilitation unit ( institutional period ) and up to 3 months after institutional discharge ( community period ) .\
METHODS	The maximal study period was 6 months .\
METHODS	A total of 224 subjects with traumatic SCI of less than 3 months ' duration who use IC .\
METHODS	The participants were randomized within 10 days of starting IC to either single-use hydrophilic-coated ( SpeediCath ) or polyvinyl chloride uncoated ( Conveen ) catheters .\
METHODS	The time from the first catheterization to the first antibiotic-treated symptomatic UTI was measured as well as the total number of symptomatic UTIs during the study period .\
RESULTS	The time to the first antibiotic-treated symptomatic UTI was significantly delayed in the hydrophilic-coated catheter group compared with the uncoated catheter group .\
RESULTS	The delay corresponded to a 33 % decrease in the daily risk of developing the first symptomatic UTI among participants who used the hydrophilic-coated catheter .\
RESULTS	In the institutional period , the incidence of antibiotic-treated symptomatic UTIs was reduced by 21 % ( P < .05 ) in the hydrophilic-coated catheter group .\
CONCLUSIONS	The use of a hydrophilic-coated catheter for IC is associated with a delay in the onset of the first antibiotic-treated symptomatic UTI and with a reduction in the incidence of symptomatic UTI in patients with acute SCI during the acute inpatient rehabilitation .\
CONCLUSIONS	Using a hydrophilic-coated catheter could minimize UTI-related complications , treatment costs , and rehabilitation delays in this group of patients , and reduce the emergence of antibiotic-resistant organisms .\
\
###17879532\
OBJECTIVE	To investigate the relationship between efficacy of Chaihu Taoren Decoction ( CTD ) and the polymorphism of valine-alanine missense mutation of 9th codan ( Val9Ala , T1183C ) of superoxide dismutase ( SOD ) in patients with tardive dyskinesia ( TD ) .\
METHODS	Severity of TD was assessed by abnormal involuntary movement scale ( AIMS ) , and the psychologic symptoms were rated by the positive and negative symptoms scale ( PANSS ) .\
METHODS	The sample size consisted of 119 patients with TD assigned to the TD group , 129 patients of chronic schizophrenia with the general condition matched strictly with that of the enrolled TD patients assigned to the non-TD group , and 148 healthy persons assigned to the normal group .\
METHODS	The gene distribution rate of Val9Ala gene was analyzed using polymerase chain reaction ( PCR ) - based restriction fragment length polymorphism ( RFLP ) analysis , and the therapeutic effect of CTD on 36 patients with TD was observed after 12 weeks treatment .\
RESULTS	There was no significant difference in genotype and allelic gene frequency of SOD Val9Ala among the TD , non-TD and normal groups ( P > 0.05 ) .\
RESULTS	Comparison of the AIMS score in TD patients with various Val9Ala genotypes showed that the difference of AIMS scores in patients with TT and CT genotype was not significant ( P > 0.05 ) , but CTD did show a better efficacy in TD patients with CT heterozygote than in those with TT homozygote ( P < 0.05 ) .\
CONCLUSIONS	The CTD could effectively relieve the symptoms of TD , its efficacy might be related with the genotype of SOD , and 9Ala is considered to be a protective factor for the susceptibility to TD .\
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###23043090\
OBJECTIVE	To compare the effectiveness of classroom based cognitive behavioural therapy with attention control and usual school provision for adolescents at high risk of depression .\
METHODS	Three arm parallel cluster randomised controlled trial .\
METHODS	Eight UK secondary schools .\
METHODS	Adolescents ( n = 5030 ) aged 12-16 years in school year groups 8-11 .\
METHODS	Year groups were randomly assigned on a 1:1:1 ratio to cognitive behavioural therapy , attention control , or usual school provision .\
METHODS	Allocation was balanced by school , year , number of students and classes , frequency of lessons , and timetabling .\
METHODS	Participants were not blinded to treatment allocation .\
METHODS	Cognitive behavioural therapy , attention control , and usual school provision provided in classes to all eligible participants .\
METHODS	Outcomes were collected by self completed questionnaire administered by researchers .\
METHODS	The primary outcome was symptoms of depression assessed at 12 months by the short mood and feelings questionnaire among those identified at baseline as being at high risk of depression .\
METHODS	Secondary outcomes included negative thinking , self worth , and anxiety .\
METHODS	Analyses were undertaken on an intention to treat basis and accounted for the clustered nature of the design .\
RESULTS	1064 ( 21.2 % ) adolescents were identified at high risk of depression : 392 in the classroom based cognitive behavioural therapy arm , 374 in the attention control arm , and 298 in the usual school provision arm .\
RESULTS	At 12 months adjusted mean scores on the short mood and feelings questionnaire did not differ for cognitive behavioural therapy versus attention control ( -0.63 , 95 % confidence interval -1.85 to 0.58 , P = 0.41 ) or for cognitive behavioural therapy versus usual school provision ( 0.97 , -0.20 to 2.15 , P = 0.12 ) .\
CONCLUSIONS	In adolescents with depressive symptoms , outcomes were similar for attention control , usual school provision , and cognitive behavioural therapy .\
CONCLUSIONS	Classroom based cognitive behavioural therapy programmes may result in increased self awareness and reporting of depressive symptoms but should not be undertaken without further evaluation and research .\
BACKGROUND	Current Controlled Trials ISRCTN19083628 .\
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###7867354\
OBJECTIVE	To evaluate the comparative safety and effectiveness of intravenous infusion of propofol or midazolam when used for 12 to 24 hrs of sedation and to evaluate the quality of sedation during stimulation .\
METHODS	An open , comparative , prospective , randomized study .\
METHODS	Surgical intensive care unit ( ICU ) in a university hospital .\
METHODS	Postoperative , intubated , general surgical , and orthopedic patients requiring mechanical ventilation ( n = 60 ) .\
METHODS	None .\
METHODS	Assessments were made at baseline ( 0 time ) , 5 , 10 , 15 , 30 , 45 , and 60 mins ; at 2 , 4 , 6 , 8 , 10 , 12 , 14 , 16 , 18 , 20 , 22 , and 24 hrs ; and at the end of sedation .\
METHODS	The assessments included systolic , mean , and diastolic blood pressures , heart rate , two-lead electrocardiogram , pulse oximetry oxygen saturation , FIO2 , end-tidal CO2 , respiratory rate , ventilator rate , tidal volume , and sedation scale .\
METHODS	Vital signs and the sedation scale were obtained at 30 , 60 , and 90 mins and at 2 , 4 , 12 , and 24 hrs after the end of sedation .\
METHODS	At approximately 8 hrs and 24 hrs ( or at the end of sedation ) , the patient 's CO2 production was calculated over a 5-min interval .\
METHODS	Every 4 hrs , the nurse would summarize and rate patient response during stimulation as well as the overall rating of the sedation and patient ability to tolerate the ICU setting .\
RESULTS	There were no significant differences in pulse oximetry , arterial blood gas values , or respiratory measurements during sedation with propofol or midazolam .\
RESULTS	The mean heart rate was slower in the propofol group throughout the sedation and postsedation periods .\
RESULTS	The rating of sedation and tolerance of the ICU environment were significantly better for the propofol-treated group .\
RESULTS	Postsedation , the propofol group woke up faster on discontinuation of the sedative .\
CONCLUSIONS	Propofol was as safe and as efficacious as midazolam for continuous intravenous sedation .\
CONCLUSIONS	The quality of sedation was better in the propofol group .\
\
###23194103\
OBJECTIVE	To evaluate the effects of an advanced practice nurse ( APN ) in-home health consultation program ( HCP ) on quality of life , health indicators ( falls , acute events ) , and healthcare utilization .\
METHODS	Randomized clinical trial .\
METHODS	One urban area in the German-speaking part of Switzerland .\
METHODS	Four hundred sixty-one community-dwelling individuals aged 80 and older ( mean age 85 , 72.7 % female , all Caucasian ) participated in the intervention ( n = 231 ) and control ( n = 230 ) groups .\
METHODS	After a comprehensive geriatric assessment , participants were randomly assigned to the 9-month HCP with four in-home visits and three phone calls from APNs or to a control group with standard care with no intervention .\
METHODS	The primary outcome was quality of life at 3 , 6 , and 9 months .\
METHODS	Secondary outcomes were incidence of falls , acute events due to health problems , and healthcare utilization measured for 3-month periods at 3 , 6 , and 9 months .\
RESULTS	The intervention and control groups did not differ significantly on any dimension of the World Health Organization Quality of Life questionnaire but differed significantly over 9 months in self-reported acute events ( 116 vs 168 , relative risk ( RR ) = 0.70 , P = .001 ) , falls ( 74 vs 101 , RR = 0.71 , P = .003 ) , consequences of falls ( 63.1 % vs 78.7 % , chi-square = 7.39 , P = .007 ) , and hospitalizations ( 47 vs 68 , RR = .70 , P = .03 ) .\
CONCLUSIONS	The in-home HCP provided by APNs and guided by the principles of health promotion , empowerment , partnership , and family-centeredness , can be effective in reducing adverse health outcomes such as falls , acute events , and hospitalizations .\
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###20846018\
BACKGROUND	Women with heart disease have adverse psychosocial profiles and poor attendance in cardiac rehabilitation ( CR ) programs .\
BACKGROUND	Few studies examine CR programs tailored for women for improving their quality of life ( QOL ) .\
METHODS	This randomized clinical trial ( RCT ) compared QOL among women in a traditional CR program with that of women completing a tailored program that included motivational interviewing guided by the Transtheoretical Model ( TTM ) of behavior change .\
METHODS	Two measures of QOL , the Multiple Discrepancies Theory questionnaire ( MDT ) and the Self-Anchoring Striving Scale ( SASS ) , were administered to 225 women at baseline , postintervention , and 6-month follow-up .\
METHODS	Analysis of Variance ( ANOVA ) was used to compare changes in QOL scores over time .\
RESULTS	Baseline MDT and SASS scores were 35.1 and 35.5 and 7.1 and 7.0 for the tailored and traditional CR groups , respectively .\
RESULTS	Postintervention , MDT and SASS scores increased to 37.9 and 7.9 , respectively , for the tailored group compared with 35.9 and 7.1 for the traditional group .\
RESULTS	Follow-up scores were 37.7 and 7.6 for the tailored group and 35.7 and 7.1 for the traditional group .\
RESULTS	Significant group by time interactions were found .\
RESULTS	Subsequent tests revealed that MDT and SASS scores for the traditional group did not differ over time .\
RESULTS	The tailored group showed significantly increased MDT and SASS scores from baseline to posttest , and despite slight attenuation from posttest to 6-month follow-up , MDT and SASS scores remained higher than baseline .\
CONCLUSIONS	The CR program tailored for women significantly improved global QOL compared with traditional CR .\
CONCLUSIONS	Future studies should explore the mechanisms by which such programs affect QOL .\
\
###22885319\
BACKGROUND	Post-operative nausea and vomiting ( PONV ) is common .\
BACKGROUND	5HT 3 receptor antagonists are commonly used drugs for its prevention .\
BACKGROUND	A study was designed to compare the efficacy and safety of ramosetron and ondansetron in patients undergoing laparoscopic cholecystectomy ( lap chole ) .\
METHODS	A prospective randomized case controlled study was conducted at J. N. Medical College Hospital , Aligarh Muslim University , Aligarh , India , in patients who underwent lap chole following intravenous administration of ondansetron ( 4mg ) or ramosetron ( 0.3 mg ) at the end of surgery , and efficacy as well as side effects of ondansetron and ramosetron was documented and compared .\
RESULTS	One hundred and thirty adult females undergoing lap chole were studied - 65 patients in each of the two groups .\
RESULTS	In first 24 h after surgery , complete response ( No PONV ) was observed in 28 patients of the ondansetron group and in 32 patients of the ramosetron group ( P > 0.05 ) .\
RESULTS	Complete response in the second 24 h after surgery was observed in 30 patients of the ondansetron group and in 45 patients of the ramosetron group ( P < 0.05 ) .\
RESULTS	During the first and second 24 h , PONV requiring rescue antiemetic was significantly higher ( P < 0.05 ) in the ondansetron group as compared to the ramosetron group .\
RESULTS	Adverse drug effects in the post-operative period were observed in 11 and 8 patients in ondansetron and ramosetron groups respectively ( P > 0.05 ) .\
CONCLUSIONS	Ramosetron was found safe and more effective antiemetic than ondansetron in patients undergoing lap chole .\
\
###10783220\
BACKGROUND	Although age is the most important variable associated with death among patients with persistent ST-segment elevation , its impact on outcome among patients without persistent ST-segment elevation remains unknown .\
BACKGROUND	Moreover , the impact of age on the efficacy of antiplatelet therapy with eptifibatide is unknown .\
METHODS	We analyzed the impact of increased age on outcome ( death or [ re ] infarction ) among patients enrolled in PURSUIT ( Platelet Glycoprotein IIb/IIIa in Unstable Angina Receptor Suppression Using Integrilin Therapy ) , a prospective , randomized study comparing placebo versus eptifibatide therapy in acute coronary syndromes without persistent ST-segment elevation .\
METHODS	The 9461 patients were divided into 10-year age groups : < 50 , 50-59 , 60-69 , 70-79 , and > / = 80 .\
METHODS	In addition , we examined whether age had an impact on the efficacy of eptifibatide therapy .\
RESULTS	Eptifibatide improved outcome at 30 days ( P = .04 ) .\
RESULTS	There was no interaction among age and treatment ( placebo vs eptifibatide ) and adjusted outcome ( P = .16 for death or [ re ] infarction at 30 days ) .\
RESULTS	Despite their worse clinical profile , older patients were less likely to undergo coronary angiography at 30 days : 936 ( 71 % ) , 1489 ( 68 % ) , 1969 ( 65 % ) , 1357 ( 57 % ) , and 193 ( 38 % ) in the respective age groups .\
RESULTS	Death or ( re ) infarction at 30 days occurred in 121 ( 9 % ) , 255 ( 12 % ) , 447 ( 15 % ) , 460 ( 19 % ) , and 134 ( 26 % ) in the respective age groups , and at 6 months in 149 ( 11 % ) , 301 ( 14 % ) , 547 ( 18 % ) , 575 ( 24 % ) , and 162 ( 32 % ) .\
RESULTS	For a 10-year difference in age group , the adjusted odds for death or ( re ) infarction were greater by 33 % within 30 days and by 34 % within 6 months .\
RESULTS	These trends persisted for patients with or without myocardial infarction on presentation .\
CONCLUSIONS	Age did not significantly affect the efficacy of eptifibatide .\
CONCLUSIONS	Older age among patients with acute coronary syndromes was associated with worse baseline characteristics , fewer invasive procedures , and worse outcome .\
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###10828770\
OBJECTIVE	Cost concerns may inhibit emergency medical services ( EMS ) use .\
OBJECTIVE	Novel tax-based and subscription prepayment programs indemnify patients against the cost of EMS treatment and transport .\
OBJECTIVE	We determine whether the presence of ( or enrollment in ) prepayment plans increase EMS use among patients with acute chest discomfort , particularly those residing in low-income areas , those lacking private insurance , or both .\
METHODS	This study uses a subset of baseline data from the REACT trial , a multicenter , randomized controlled community trial designed , in part , to increase EMS use .\
METHODS	The sample includes 860 consecutive noninstitutionalized patients ( > 30 years old ) presenting with nontraumatic chest discomfort to hospital emergency departments in 4 Oregon/Washington communities .\
METHODS	The association between prepayment systems and EMS use was analyzed using multivariable logistic regression .\
RESULTS	Overall EMS use was 52 % ( n = 445 ) .\
RESULTS	Among EMS users , 338 ( 75 % ) were subsequently admitted to the hospital and 110 ( 25 % ) were released from the ED .\
RESULTS	Prepayment was not associated with increased EMS use in the overall patient sample .\
RESULTS	However , patients residing in low-income census block groups ( median annual income < $ 30,000 ) were 2.6 times ( 95 % confidence interval [ CI ] 1.4 to 4.8 ) more likely to use EMS when a prepayment system was available than when no system was present .\
RESULTS	No association was noted among higher-income block group residents .\
RESULTS	Among low-income block group residents lacking private insurance , prepayment systems were associated with 3.8 times ( 95 % CI 1.2 to 13.4 ) greater EMS usage .\
CONCLUSIONS	Economic considerations may affect EMS system utilization among underinsured and low-income patients experiencing a cardiac event .\
CONCLUSIONS	Prepayment systems may increase EMS utilization among these groups .\
\
###12680449\
OBJECTIVE	To determine efficacy of a commercially available hyperimmune plasma product for prevention of naturally acquired pneumonia caused by Rhodococcus equi in foals .\
METHODS	Randomized clinical trial .\
METHODS	165 foals .\
METHODS	Foals were randomly assigned to 1 of 2 groups ( hyperimmune plasma or nontreated controls ) .\
METHODS	Foals with failure of passive transfer ( FPT ) of immunity were treated with hyperimmune plasma and evaluated as a third group .\
METHODS	Foals that received plasma were given 950 ml between 1 and 10 days of age and between 30 and 50 days of age .\
METHODS	A tracheobronchial aspirate was obtained from foals with clinical signs of respiratory tract disease for bacteriologic culture .\
RESULTS	A significant difference in incidence of pneumonia caused by R equi in foals with adequate passive transfer was not detected between foals that received plasma ( 19.1 % ) and nontreated foals ( 30 % ) .\
RESULTS	Of 13 foals without FPT that received plasma and developed pneumonia caused by R equi , 12 developed disease prior to administration of the second dose of hyperimmune plasma .\
RESULTS	Incidence of undifferentiated pneumonia of all causes was not different between groups .\
CONCLUSIONS	Intravenous administration of the commercially available hyperimmune plasma was safe , and the product contained high concentrations of anti-R equi antibodies .\
CONCLUSIONS	However , within this limited foal population , the difference in incidence of pneumonia caused by R equi observed between foals that received plasma and control foals was not significant .\
\
###18567089\
OBJECTIVE	To investigate the therapeutic effect of traditional Chinese traditional medicines Da Cheng Qi Decoction ( Timely-Purging and Yin-Preserving Decoction ) and Glauber 's salt combined with conservative measures on abdominal compartment syndrome ( ACS ) in severe acute pancreatitis ( SAP ) patients .\
METHODS	Eighty consecutive SAP patients , admitted for routine non-operative conservative treatment , were randomly divided into study group and control group ( 40 patients in each group ) .\
METHODS	Patients in the study group received Da Cheng Qi Decoction enema for 2 h and external use of Glauber 's salt , once a day for 7 d. Patients in the control group received normal saline ( NS ) enema .\
METHODS	Routine non-operative conservative treatments included non-per os nutrition ( NPON ) , gastrointestinal decompression , life support , total parenteral nutrition ( TPN ) , continuous peripancreatic vascular pharmaceutical infusion and drug therapy .\
METHODS	Intra-cystic pressure ( ICP ) of the two groups was measured during treatment .\
METHODS	The effectiveness and outcomes of treatment were observed and APACHE II scores were applied in analysis .\
RESULTS	On days 4 and 5 of treatment , the ICP was lower in the study group than in the control group ( P < 0.05 ) .\
RESULTS	On days 3-5 of treatment , acute physiology and chronic health evaluation II ( APACHE II ) scores for the study and control groups were significantly different ( P < 0.05 ) .\
RESULTS	Both the effectiveness and outcome of the treatment with Da Cheng Qi Decoction on abdominalgia , burbulence relief time , ascites quantity , cyst formation rate and hospitalization time were quite different between the two groups ( P < 0.05 ) .\
RESULTS	The mortality rate for the two groups had no significant difference .\
CONCLUSIONS	Da Cheng Qi Decoction enema and external use of Glauber 's salt combined with routine non-operative conservative treatment can decrease the intra-abdominal pressure ( IAP ) of SAP patients and have preventive and therapeutic effects on abdominal compartment syndrome of SAP .\
\
###21095487\
BACKGROUND	Growth hormone ( GH ) is used to treat pediatric and adult GH deficiency ( GHD ) and growth failure in , among others , patients with Turner syndrome or children born small for gestational age .\
BACKGROUND	To improve treatment adherence , self-injection devices should be easy to learn , easy to use , and well accepted , especially in pediatric patients .\
BACKGROUND	Several GH pen devices are available , each with distinct features designed for specific patient needs .\
OBJECTIVE	This study compared injection time and intuitiveness of a prefilled test injection device ( Norditropin FlexPro , Novo Nordisk A/S , Bagsvrd , Denmark ) with those of 2 commercially available durable injection devices ( easypod , Merck Serono SA , Geneva , Switzerland ; and Genotropin , Pfizer Inc , New York , New York ) in GH-treated pediatric patients .\
OBJECTIVE	Dose accuracy , application errors , intuitiveness , usability , device features , ease of learning , ease of use , and overall preference were also assessed .\
METHODS	This noninterventional , randomized , open-label , crossover study enrolled patients aged 10 to < 18 years who were diagnosed with GHD or Turner syndrome or were born small for gestational age .\
METHODS	Patients were allocated to an intuitiveness group ( without instruction ) or an instruction group and assigned to 1 of 3 sequences of device testing .\
METHODS	For each device , time taken to deliver a mock injection of test medium ( FlexPro ) or GH ( easypod and Genotropin ) into an Eppendorf tube and the delivered dose were measured .\
METHODS	Dose accuracy and application errors were assessed by a health care professional .\
METHODS	Patients assessed the intuitiveness ( intuitiveness group only ) , device features , ease of learning , ease of use , and overall preference of the devices using questionnaires .\
RESULTS	Included in the study were 56 patients ( mean [ SD ] age , 13.6 [ 2.1 ] years ; 63 % male ; GHD , 44 patients ; Turner syndrome , 3 ; born small for gestational age , 9 ) : 30 in the intuitiveness group and 26 in the instruction group .\
RESULTS	In the intuitiveness group , the mean ( SD ) mock injection time was significantly shorter with FlexPro ( 47.0 [ 49.0 ] seconds ) than with the easypod ( 219.2 [ 72.6 ] seconds ; P < 0.001 ) or the Genotropin pen ( 95.1 [ 78.4 ] seconds ; P < 0.01 ) .\
RESULTS	In the instruction group , injection time was also shortest with FlexPro ( 30.7 [ 10.8 ] seconds vs 59.6 [ 13.1 ] with easypod and 40.7 [ 18.6 ] with the Genotropin pen ; both , P < 0.001 ) .\
RESULTS	Most patients ( 70 % ) ranked FlexPro as the most intuitive device ( easypod , 0 % ; Genotropin , 30 % ) .\
RESULTS	In both the intuitiveness and instruction groups , a significantly greater proportion of patients considered FlexPro easiest to learn compared with the easypod and Genotropin devices ( both , P < 0.001 ) , although more patients preferred the easypod or Genotropin devices than FlexPro with regard to appearance ( intuitiveness group : FlexPro , 8 patients ; easypod , 9 ; and Genotropin , 13 ; instruction group : FlexPro , 4 ; easypod , 10 ; and Genotropin , 12 ) and quality ( intuitiveness group : FlexPro , 6 patients ; easypod , 10 ; and Genotropin , 14 ; instruction group : FlexPro , 8 ; easypod , 12 ; and Genotropin , 6 ) , and easy - pod 's delivery feedback feature was preferred by more patients ( intuitiveness group : FlexPro , 8 patients ; easypod , 14 ; Genotropin , 8 ; instruction group : FlexPro , 8 ; easypod , 14 ; and Genotropin , 4 ) .\
RESULTS	Dose accuracies ( as assessed by weighing the delivered dose and calculating variation in the delivered dose by device ) were 4.6 % with FlexPro , 14.6 % with easypod , and 20.6 % with the Genotropin pen in the intuitiveness group , and 2.7 % with FlexPro , 5.8 % with easypod , and 24.4 % with the Genotropin pen in the instruction group .\
CONCLUSIONS	In this study , Norditropin FlexPro was associated with shorter injection times , higher dose accuracy , and greater intuitiveness , and was rated as easier to learn compared with the easypod and Genotropin devices .\
\
###22253252\
BACKGROUND	Nonoperative options for osteochondral lesions ( OCLs ) of the talar dome are limited , and currently , there is a lack of scientific evidence to guide management .\
OBJECTIVE	To evaluate the short-term efficacy and safety of platelet-rich plasma ( PRP ) compared with hyaluronic acid ( HA ) in reducing pain and disability caused by OCLs of the ankle .\
METHODS	Randomized controlled trial ; Level of evidence , 2 .\
METHODS	Thirty-two patients aged 18 to 60 years were allocated to a treatment by intra-articular injections of either HA ( group 1 ) or PRP ( plasma rich in growth factors [ PRGF ] technique , group 2 ) for OCLs of the talus .\
METHODS	Thirty OCLs , 15 per arm , received 3 consecutive intra-articular therapeutic injections and were followed for 28 weeks .\
METHODS	The efficacy of the injections in reducing pain and improving function was assessed at each visit using the American Orthopaedic Foot and Ankle Society ( AOFAS ) Ankle-Hindfoot Scale ( AHFS ) ; a visual analog scale ( VAS ) for pain , stiffness , and function ; and the subjective global function score .\
RESULTS	The majority of patients were men ( n = 23 ; 79 % ) .\
RESULTS	The AHFS score improved from 66 and 68 to 78 and 92 in groups 1 and 2 , respectively , from baseline to week 28 ( P < .0001 ) , favoring PRP ( P < .05 ) .\
RESULTS	Mean VAS scores ( 1 = asymptomatic , 10 = severe symptoms ) decreased for pain ( group 1 : 5.6 to 3.1 ; group 2 : 4.1 to 0.9 ) , stiffness ( group 1 : 5.1 to 2.9 ; group 2 : 5.0 to 0.8 ) , and function ( group 1 : 5.8 to 3.5 ; group 2 : 4.7 to 0.8 ) from baseline to week 28 ( P < .0001 ) , favoring PRP ( P < .05 for stiffness , P < .01 for function , P > .05 for pain ) .\
RESULTS	Subjective global function scores , reported on a scale from 0 to 100 ( with 100 representing healthy , preinjury function ) improved from 56 and 58 at baseline to 73 and 91 by week 28 for groups 1 and 2 , respectively ( P < .01 in favor of PRP ) .\
CONCLUSIONS	Osteochondral lesions of the ankle treated with intra-articular injections of PRP and HA resulted in a decrease in pain scores and an increase in function for at least 6 months , with minimal adverse events .\
CONCLUSIONS	Platelet-rich plasma treatment led to a significantly better outcome than HA .\
\
###12032789\
OBJECTIVE	To determine if amnioinfused normal saline or lactated Ringer 's solution in cases of meconium-stained amniotic fluid is associated with significant changes on neonatal plasma electrolyte concentrations or pH.\
METHODS	This was a prospective randomized study using normal saline or lactated Ringer 's solution for amnioinfusion in women with thick meconium in the amniotic fluid .\
METHODS	The control group was composed of women with clear amniotic fluid not receiving amnioinfusion .\
METHODS	Cord blood arterial sampling was analyzed for sodium , potassium , and chloride plasma concentrations and pH. The sample sizes allowed for an alpha of 0.05 and power of 0.80 .\
RESULTS	We evaluated 61 cases ( 20 normal saline solution , 20 lactated Ringer 's solution , and 21 control ) .\
RESULTS	No significant differences in cord blood arterial plasma concentrations of sodium ( p = 0.43 ) , potassium ( p = 0.21 ) , chloride ( p = 0.68 ) , and pH ( p = 0.11 ) were noted .\
CONCLUSIONS	Use of normal saline or lactated Ringer 's solution for amnioinfusion in meconium-stained amniotic fluid is not associated with changes on neonatal plasma electrolyte concentrations or pH.\
\
###20859892\
BACKGROUND	Contrast-induced nephropathy ( CIN ) is a serious complication of percutenous coronary interventions ( PCI ) .\
BACKGROUND	Proper hydration reduces the risk of PCI .\
BACKGROUND	Wheter oral hydration is as effective as intravenous one has not been well established .\
OBJECTIVE	To determine the effects of oral hydration with mineral water versus intravenous hydration with isotonic solution ( 0.9 % NaCl ) on renal function in diabetic patients undergoing coronary angiography and angioplasty .\
METHODS	The study included 102 patients ( age 67 7.8 years , 44 female/58 male ) .\
METHODS	Eligible patients ( group 1 - 52 pts ) were hydrated intravenously ( 1 mL/kg/h ) 6 hours before and during 12 hours following PCI with isotonic solution ( 0.9 % NaCl ) .\
METHODS	Fifty patients ( group 2 ) were randomised to receive oral mineral water ( 1 mL/kg/h ) 6-12 hours before and during 12 hours following angiography or angioplasty .\
METHODS	All patients during the procedure received contrast medium ioversol .\
METHODS	Primary endpoint of the study was the evaluation of renal function before and 72 hours after contrast medium administration .\
RESULTS	Baseline creatinine clearance was 70.3 21.22 mL/min in group 1 and 78.69 19.92 mL/min in group 2 ( NS ) .\
RESULTS	The mean volume of contrast medium was 101.1 36.7 mL in group 1 and 110.4 45.3 mL in group 2 ( NS ) .\
RESULTS	At 72 hours after the procedure , creatinine clearance was 65.3 23.39 mL/min in group 1 and 73.5 21.94 mL/min in group 2 ( NS ) .\
CONCLUSIONS	Our study demonstrates that the oral hydration with mineral water and intravenous hydration with 0.9 % NaCl have similar effects on renal function in diabetic patients undergoing coronary angiography and angioplasty .\
\
###22595363\
BACKGROUND	To investigate the influence of galantamine on linguistic function , any associated factors in patients with chronic post-stroke aphasia were analysed .\
METHODS	45 patients younger than 75 years with chronic aphasia ( 1 year since onset ) were prospectively enrolled in the study .\
METHODS	Language testing was performed at weeks 0 and 16 .\
METHODS	Initial galantamine dose was 8 mg/day for 4 weeks , and 16 mg/day for the following 12 weeks .\
METHODS	Efficacy was evaluated by the sum of four domains ( spontaneous speech , comprehension , repetition and naming ) on the aphasia quotient ( AQ ) of the Western Aphasia Battery from baseline ( AQ1 ) to endpoint ( AQ2 ) .\
METHODS	Patients were considered as ` responding ' if the increase in AQ was 20 .\
RESULTS	Mean age was 60.4 years ( 22-74 ) and 14 patients were female .\
RESULTS	Mean duration of aphasia was 2.21.5 years .\
RESULTS	There was a significant increase in the total AQ score in the galantamine group ( n = 23 , 48.5-57 .0 percentile ; p = 0.007 ) but not in the control group ( n = 22 , 54.3-54 .9 percentile ; p = 0.308 ) .\
RESULTS	The AQ2 score was independently associated with AQ1 , galantamine administration and Mini-Mental State Examination ( MMSE ) score in multiple linear regression models .\
RESULTS	With the galantamine group , the good responders ( vs poor responders ) had a higher level of education ( p = 0.048 ) , higher baseline MMSE score ( p = 0.009 ) and a subcortical dominant pattern ( p = 0.030 ) .\
RESULTS	After adjusting for potential variables , subcortical dominant lesion was the independent determinant for galantamine responsiveness ( OR 30.3 ; 95 % CI 1.1 to 805.9 , p = 0.041 ) .\
CONCLUSIONS	Administration of galantamine had a beneficial effect on chronic post-stroke aphasia , and was more prominent in subcortical dominant lesions .\
\
###24329481\
BACKGROUND	Gold-standard assessment of acute wound healing has traditionally been through histological analysis of biopsied tissue .\
BACKGROUND	However , this process is invasive with recognized side-effects .\
BACKGROUND	Optical coherence tomography ( OCT ) is a noninvasive technique generating high-resolution real-time images of cutaneous architecture .\
OBJECTIVE	To compare OCT with histological assessment of in vivo acute wound healing and ascertain the level of agreement between modalities for measurement of defined cutaneous structures .\
METHODS	Punch biopsies ( 5mm ) were harvested from 50 healthy volunteers .\
METHODS	Wounds healed by secondary intention until they were re-excised 7 , 14 , 21 or 28days later depending on random group allocation .\
METHODS	Wounds were assessed weekly for 6weeks using OCT and compared with histological findings derived from time-matched biopsies .\
METHODS	Dimensions of four cutaneous structures were measured using both modalities and the level of agreement was established by Bland-Altman analysis .\
METHODS	The mean greyscale value ( MGV ) of the upper reticular dermis was derived from OCT images at all time points .\
RESULTS	Both techniques showed anatomical congruity in normal and wounded skin with correlating architectural changes associated with inflammatory , proliferative and remodelling wound healing phases .\
RESULTS	MGV was significantly increased 6weeks after wounding ( P = 0001 ) and may represent a novel measure of wound fibrosis .\
RESULTS	Despite good association of histomorphometric values with low but consistent bias ( range -4181 to 0431m ) , Bland-Altman plots demonstrated poor agreement between OCT and histology .\
CONCLUSIONS	Optical coherence tomography enabled accurate assessment of healing tissue comparable with histological analysis of biopsy specimens .\
CONCLUSIONS	This noninvasive tool is highly suited to wound assessment and may represent a diagnostic alternative to punch biopsies .\
\
###19813008\
OBJECTIVE	The aims of the study were to investigate interindividual variations in the bioavailability of salmon calcitonin ( sCT ) following single oral 0.8 mg doses at three different times of the day , and intraindividual variation in sCT bioavailability at each end of a 14-day treatment period .\
OBJECTIVE	We also investigated correlations between exposure to sCT and levels of the bone resorption biomarker serum C-terminal telopeptide of collagen type I ( CTX-I ) .\
METHODS	Participants were from two randomized , double-blind , placebo-controlled studies .\
METHODS	In study I , healthy postmenopausal women received a single dose of 0.8 mg of oral sCT or placebo at 08:00 ( n = 42 ) , 17:00 ( n = 20 ) , or at 22:00 ( n = 19 ) .\
METHODS	In study II , age-matched men or postmenopausal women with osteoarthritis received 0.8 mg oral sCT ( n = 26 ) or placebo ( n = 23 ) twice daily for 14 days , with dosing at 08:00 and 17:00 .\
METHODS	In both studies , drug exposure was assessed by plasma sCT concentrations , and bone resorption by CTX-I levels .\
RESULTS	The variability in exposure between patients , measured as coefficient of variation ( CV ) , was as follows : 22 % for the morning dose , 30 % for the predinner dose , and 34 % for the evening dose .\
RESULTS	In study 1 , a high degree of correlation was seen between the level of exposure following a single 0.8 mg dose of sCT and suppression of serum CTX-I , with Pearson correlation coefficients of r = -0.74 , -0.96 , and -0.78 , following doses at 08:00 , 17:00 , and 22:00 , respectively .\
RESULTS	In study II , exposure to sCT varied widely within the same individuals between dosing days 1 and 14 , with weak correlations of r = 0.40 and 0.38 at the dose times 08:00 and 17:00 , respectively .\
RESULTS	As expected from this finding , the intraindividual response in serum CTX-I levels was non-significantly associated on dosing days 1 and 14 ( r = 0.34 and r = 0.27 at dose times 08:00 and 17:00 , respectively ) .\
CONCLUSIONS	Increased bioavailability of orally administered 0.8 mg sCT was highly correlated with increased suppression of the bone resorption marker serum CTX-I irrespective of the time of day .\
CONCLUSIONS	However , the high inter - and intraindividual variability in sCT exposure demonstrates the importance of determining the optimum conditions for ensuring the most beneficial sCT uptake .\
\
###19215547\
OBJECTIVE	To compare the efficacy of a single dose of 100 microg intramuscular carbetocin to a single dose of intramuscular syntometrine ( 0.5 mg ergometrine and 5IU oxytocin ) , in preventing post-partum hemorrhage ( PPH ) in high risk patients following vaginal delivery .\
METHODS	A prospective , randomized controlled study was conducted in a tertiary hospital where 120 pregnant women with risk factors for PPH who delivered vaginally were randomized into two groups : the study group where 100 microg intramuscular carbetocin was administered and the control group , who received intramuscular syntometrine .\
METHODS	Outcome measures compared included changes in vital signs , amount of intrapartum blood loss , uterine fundal position , addition of another oxytocic agent , side-effects of the drugs , amount of lochia and hemoglobin drop after 24 hours post-partum .\
METHODS	Incidence of PPH or other adverse events were also compared .\
RESULTS	There were no significant differences in terms of requirement for additional oxytocic agents , time interval to well contracted uterus , blood transfusion requirements , adverse effects or complications .\
RESULTS	There was a significantly lower mean estimated blood loss in the carbetocin group compared to the syntometrine group ( 244 + / - 114 mL vs 343 + / - 143 mL , 95 % CI 52-146 mL ) .\
RESULTS	There was also a significantly reduced drop in hemoglobin in the carbetocin group compared to the syntometrine group ( 0.3 + / - 0.2 g/dL vs 0.4 + / - 0.2 g/dL , 95 % CI 0.1-0 .2 g/dL ) .\
CONCLUSIONS	Intramuscular carbetocin may be more effective than intramuscular syntometrine in reducing post-partum blood loss and the drop in hemoglobin level .\
\
###25550337\
OBJECTIVE	To evaluate maintenance of response while reducing intravenous abatacept dose from ~ 10 mg/kg to ~ 5 mg/kg in patients with early rheumatoid arthritis ( RA ) who achieved disease activity score ( DAS ) 28 ( erythrocyte sedimentation rate , ESR ) < 2.6 .\
METHODS	This 1-year , multinational , randomised , double-blind substudy evaluated the efficacy and safety of ~ 10 mg/kg and ~ 5 mg/kg abatacept in patients with early RA with poor prognosis who had reached DAS28 ( ESR ) < 2.6 at year 2 of the AGREE study .\
METHODS	The primary outcome was time to disease relapse ( defined as additional disease-modifying antirheumatic drugs , 2 courses high-dose steroids , return to open-label abatacept ~ 10 mg/kg , or DAS28 ( C reactive protein ) 3.2 at two consecutive visits ) .\
RESULTS	108 patients were randomised ( ~ 10 mg/kg , n = 58 ; ~ 5 mg/kg , n = 50 ) .\
RESULTS	Three and five patients , respectively , discontinued , and four per group returned to open-label abatacept .\
RESULTS	Relapse over time and the proportion of patients relapsing were similar in both groups ( 31 % ( ~ 10 mg/kg ) vs 34 % ( ~ 5 mg/kg ) ; HR : 0.87 ( 95 % CI 0.45 to 1.69 ) ) .\
RESULTS	Mean steady-state trough serum concentration for the ~ 10 mg/kg group was 20.3-24 .1 g/mL , compared with 8.8-12 .0 g/mL for the ~ 5 mg/kg group .\
CONCLUSIONS	This exploratory study suggests that abatacept dose reduction may be an option in patients with poor prognosis early RA who achieve DAS28 ( ESR ) < 2.6 after 1 year on abatacept ( ~ 10 mg/kg ) .\
BACKGROUND	NCT00989235 .\
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###7646766\
OBJECTIVE	To determine if chymotrypsin-galactose ( CG ) treatment of sperm bound with antisperm antibodies ( ASA ) improves pregnancy rates ( PRs ) following in vitro fertilization ( IVF ) .\
METHODS	Patients with > 50 % ASA who failed to conceive despite six intrauterine insemination ( IUI ) cycles were included .\
METHODS	Initially the sperm treatments were randomized with CG vs culture medium ; subsequently only CG treatment was used .\
RESULTS	There was a significantly lower fertilization rate in those patients inseminated with sperm incubated in culture medium vs CG ( 27 % vs 47 % , P < .05 t-test ) .\
RESULTS	Similarly , a higher percentage of patients receiving culture medium treatment of sperm had failed fertilization ( 45 % ) compared to CG ( 11 % ) .\
RESULTS	Though the clinical PRs were higher with CG ( 21 % ) tham medium ( 9.5 % ) , there was no statistical difference .\
CONCLUSIONS	Though the percentage of sperm bound with antibodies are not reduced , we hypothesize that the CG treatment improves fertility by possibly mitigating the antagonistic action of these antibodies .\
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###11111356\
OBJECTIVE	To test a new prescription counseling method termed `` patient-guided counseling '' ( PGC ) in community pharmacies .\
METHODS	Post-test experimental design in which subjects were randomized to three groups .\
METHODS	Six community pharmacies ( three chain and three independent ) .\
METHODS	Patients presenting new prescriptions .\
METHODS	Patients were randomly assigned to one of three comparison groups .\
METHODS	The PGC group was given a written prompt instructing them to write any questions they wished to ask about their prescription or their medical condition .\
METHODS	The pharmacist then incorporated these questions into the subsequent verbal counseling .\
METHODS	A second group was given a written prompt encouraging them to ask the pharmacist questions .\
METHODS	This was followed by customary verbal counseling .\
METHODS	A third group served as the control .\
METHODS	No prompts were provided , but the pharmacist did provide customary verbal counseling .\
METHODS	Patients ' demographics , recall of medication information , and satisfaction with counseling .\
METHODS	Patients were contacted by telephone 5 days after the start of drug therapy to measure compliance .\
METHODS	Pharmacists rated their satisfaction with the information communicated and with their interactions with patients .\
RESULTS	Compared with customary verbal counseling , the PGC method was associated with more supplemental questions asked by the patient .\
RESULTS	Compared with the other two methods , PGC was associated with greater pharmacist satisfaction with the information communicated and slightly longer counseling sessions .\
RESULTS	No significant differences were found for patients ' overall satisfaction with counseling , recall of information , and compliance .\
CONCLUSIONS	In the community pharmacy setting , PGC fosters patient participation in medication counseling , a necessary element for the provision of pharmaceutical care .\
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###21119407\
BACKGROUND	Ear reconstruction is challenging surgery , often with poor outcomes .\
BACKGROUND	Our purpose was to develop a surgical training model for auricular reconstruction .\
METHODS	Silicone costal cartilage models were incorporated in a workshop-based instructional program .\
METHODS	Trainees were randomly divided .\
METHODS	Workshop group ( WG ) participated in an interactive session , carving frameworks under supervision .\
METHODS	Nonworkshop group ( NWG ) did not participate .\
METHODS	Standard Nagata templates were used .\
METHODS	Two further frameworks were created , first with supervision then without .\
METHODS	Groups were combined after the first carving because of frustration in the NWG .\
METHODS	Assessment was completed by 3 microtia surgeons from 2 different centers , blinded to framework origin .\
METHODS	Frameworks were rated out of 10 using Likert and visual analog scales .\
METHODS	Results were examined using SPSS ( version 14 ) , with t test , ANOVA , and Bonferroni post hoc analyses .\
RESULTS	Cartilaginous frameworks from the WG scored better for the first carving ( WG 5.5 vs NWG 4.4 ) , the NWG improved for the second carving ( WG 6.6 vs NWG 6.5 ) , and both groups scored lower with the third unsupervised carving ( WG 5.9 vs NWG 5.6 ) .\
RESULTS	Combined scores after 3 frameworks were not statistically significantly different between original groups .\
RESULTS	A statistically significant improvement was demonstrated for all carvers between sessions 1 and 2 ( P 0.09 ) , between sessions 1 and 3 ( P 0.05 ) , but not between sessions 2 and 3 , thus suggesting the necessity of in vitro practice until high scores are achieved and maintained without supervision before embarking on in vivo carvings .\
RESULTS	Quality of carvings was not related to level of training .\
CONCLUSIONS	An appropriate and applicable surgical training model and training method can aid in attaining skills necessary for successful auricular reconstruction .\
\
###19110953\
OBJECTIVE	The aims of this study were to compare ultrasonographic findings of the urethra and the tape position and mobility following the tension-free vaginal tape secure system ( TVT-S ) procedure and to correlate these data with clinical signs of cure and failure of this procedure in the treatment of stress urinary incontinence ( SUI ) in women .\
OBJECTIVE	Another aim of our study was to determine indications for particular position of the tape ( the `` hammock '' or `` U '' position ) based on ultrasonographic findings of the urethra and the tape position following TVT-S .\
METHODS	Prospective , randomized study .\
METHODS	Department of Gynecology and Obstetrics , First faculty of Medicine , Charles University and General Teaching Hospital , Prague .\
METHODS	Analyses of the position of the urethra and the tape of 85 patients were performed using perineal ultrasonography .\
METHODS	The efficacy of the TVT-S procedure was evaluated by cough test and by the International Consultation on Incontinence Questionnaire - Short Form ( ICIQ-UI SF ) .\
RESULTS	Objective assessment by cough test showed that 53 ( 62 % ) of our patients were completely dry , and in 32 ( 38 % ) patients leakage of urine persisted after the operation .\
RESULTS	From the US examination and results we can conclude that 3 months after the operation the mobility of the urethra and bladder neck are restricted .\
RESULTS	A correlation between cure effect and the restriction of the movement of the urethra was found between the position at the middle of the urethra before and after the operation .\
RESULTS	Subjective assessment of the cure effect of this operation by the ICIQ-UI SF questionnaires ( n = 81 ) showed that 39 ( 48 % ) of our patients were completely dry and 24 ( 30 % ) of patients improved , which means that in 42 ( 52 % ) patients leakage of urine persists after the operation .\
RESULTS	There are differences in the restriction of urethral mobility between the cured patients and those where leakage persisted .\
RESULTS	The middle of the urethra and UVJ are more restricted in movement in cured patients .\
RESULTS	We found no statistically significant differences between the US measurements of the position of the urethra of patients with the tape in the `` hammock '' and the `` U '' position .\
RESULTS	The only statistically significant difference found is a slightly higher tension of the `` U '' tape three months after the operation during the Valsalva maneuver ; the median width of the tape in the `` hammock '' position is 10.1 mm , while in the `` U '' position it is 8.1 ( Wilcoxon test p = 0.0056 ) .\
RESULTS	There were six patients diagnosed with urgency de novo , without urge incontinence in this series .\
RESULTS	In seven cases we found vaginal erosion .\
CONCLUSIONS	From the US examination and results we can conclude that after the TVT-S operation , mobility of the urethra and bladder neck is restricted .\
CONCLUSIONS	After comparing ultrasonographic findings of the urethra and the tape position following TVT - Secure we can determine that there is no certain indication for placement of the tape in the `` hammock '' or the `` U '' position .\
CONCLUSIONS	The cure effect for different positions of the tape is similar .\
CONCLUSIONS	In some respects the slightly higher tension of the tape in the `` U '' position suggests that this tape position may be preferred in patients with intrinsic sphincter defect ( ISD ) of the urethra .\
CONCLUSIONS	A comparison of the cure effect of the TVT-S procedure with other tape procedures suggests a lower cure effect of this operation .\
\
###15461603\
BACKGROUND	Some aspects of sublingual immunotherapy ( SLIT ) still need to be addressed : magnitude of the clinical efficacy , effect on the bronchial hyperreactivity adherence to treatment , preventive effect .\
BACKGROUND	We attempted to clarify these points in a randomized open , controlled , two parallel group study in a real-life setting .\
METHODS	Five hundred and eleven patients with allergic rhinitis with or without intermittent asthma were randomized to drugs only or drugs + SLIT ( rate 2 : 3 ) for 3 years .\
METHODS	The clinical score ( symptoms + drug intake ) was measured each year during the allergen exposure .\
METHODS	Pulmonary function test , methacholine challenge and skin tests were performed at the beginning and at the end of the study .\
METHODS	Adherence to treatment was assessed by measuring the consumed extract .\
RESULTS	Three hundred and nineteen patients received SLIT and 192 drugs only .\
RESULTS	Dropouts were 15 % in the SLIT group and 12 % in the controls .\
RESULTS	There was a significant improvement of clinical scores in the SLIT group : baseline 147 + / - 3.3 , first year 72.9 + / - 1.3 , second year 68.3 + / - 1.8 , third year 54.7 + / - 2.8 ( P < 0.0001 vs baseline ) .\
METHODS	baseline 138 + / - 2.3 , first year 124.1 + / - 3.7 , second year 111 + / - 3.3 , third year 121 + / - 3.8 ( P = NS ) .\
METHODS	Only four patients reported systemic itching .\
METHODS	Adherence was > 80 % in 72 % and > 60 % in 18 % of patients .\
METHODS	The number of patients with a positive MCh challenge decreased significantly after 3 years only in the SLIT group .\
METHODS	New skin sensitizations appeared in 38 % of the controls and in 5.9 % of the SLIT patients ( P = 0.01 ) .\
CONCLUSIONS	Sublingual immunotherapy approximately halved the clinical scores and significantly reduced the bronchial hyperreactivity .\
CONCLUSIONS	Similarly to subcutaneous immunotherapy , SLIT displayed a preventive effect on the onset of new skin sensitizations .\
CONCLUSIONS	The adherence rate was quantitatively satisfactory .\
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###22412073\
BACKGROUND	Few evidence-based weight loss treatment options exist for medically vulnerable patients in the primary care setting .\
METHODS	We conducted a 2-arm , 24-month randomized effectiveness trial in 3 Boston community health centers ( from February 1 , 2008 , through May 2 , 2011 ) .\
METHODS	Participants were 365 obese patients receiving hypertension treatment ( 71.2 % black , 13.1 % Hispanic , 68.5 % female , and 32.9 % with less than a high school educational level ) .\
METHODS	We randomized participants to usual care or a behavioral intervention that promoted weight loss and hypertension self-management using eHealth components .\
METHODS	The intervention included tailored behavior change goals , self-monitoring , and skills training , available via a website or interactive voice response ; 18 telephone counseling calls ; primary care provider endorsement ; 12 optional group support sessions ; and links with community resources .\
RESULTS	At 24 months , weight change in the intervention group compared with that in the usual care group was -1.03 kg ( 95 % CI , -2.03 to -0.03 kg ) .\
RESULTS	Twenty-four-month change in body mass index ( calculated as weight in kilograms divided by height in meters squared ) in the intervention group compared with that in the usual care group was -0.38 ( 95 % CI , -0.75 to -0.004 ) .\
RESULTS	Intervention participants had larger mean weight losses during the 24 months compared with that in the usual care group ( area under the receiver operating characteristic curve , -1.07 kg ; 95 % CI , -1.94 to -0.22 ) .\
RESULTS	Mean systolic blood pressure was not significantly lower in the intervention arm compared with the usual care arm .\
CONCLUSIONS	The intervention produced modest weight losses , improved blood pressure control , and slowed systolic blood pressure increases in this high-risk , socioeconomically disadvantaged patient population .\
CONCLUSIONS	Trial Registration clinicaltrials.gov Identifier : NCT00661817 .\
\
###19473600\
OBJECTIVE	Fesoterodine is a new , once-daily , oral , antimuscarinic agent indicated for the treatment of overactive bladder .\
OBJECTIVE	It undergoes rapid and extensive metabolism by plasma esterases to form its principal active moiety , 5-hydroxymethyl tolterodine ( 5-HMT ) .\
OBJECTIVE	The sustained-release formulation of fesoterodine delivers 5-HMT with linear , dose-proportional pharmacokinetics ( PK ) suitable for once-daily dosing .\
OBJECTIVE	This study was designed for the definitive assessment of the effect of food on 5-HMT PK using the commercial formulation of fesoterodine .\
METHODS	In this randomized , open-label , single-dose , 2-way , crossover study , fesoterodine 8 mg was administered orally to healthy subjects in either a fed ( after a high-fat , high-calorie breakfast ) or fasted state .\
METHODS	Blood samples for PK were drawn up to 36 hours after dosing .\
METHODS	Primary endpoints for food effect assessment were area under the concentration-versus-time curve up to the last sample ( AUC ( 0-tz ) ) , and maximum plasma concentration ( C ( max ) ) for 5-HMT .\
METHODS	Adverse events , vital signs , hematology , clinical chemistry , and electrocardiograms were monitored for safety assessment .\
RESULTS	A total of 16 healthy male subjects enrolled and completed the study .\
RESULTS	Mean values of both primary PK parameters of 5-HMT ( AUC ( 0-tz ) and C ( max ) ) were approximately 19 % higher after fesoterodine administration in the fed versus the fasted state .\
RESULTS	The upper limits of the corresponding 90 % confidence intervals for the `` fed/fasted '' ratios of AUC ( 0-tz ) ( 104 % , 137 % ) and C ( max ) ( 94 % , 149 % ) were not included in the prespecified acceptance range ( 80 % , 125 % ) for concluding `` no food effect . ''\
RESULTS	Secondary PK variables , ( i.e. time to maximum plasma concentration terminal elimination half-life and mean residence time ) , did not differ markedly between the fed and fasted states .\
RESULTS	Fesoterodine was well tolerated , and adverse events were mild , with no apparent difference in frequency between fed and fasted states .\
CONCLUSIONS	The hypothesis of `` no food effect '' could not be statistically confirmed ; however , only modest increases of approximately 19 % were observed for C ( max ) and AUC ( 0-tz ) of 5-HMT .\
CONCLUSIONS	This magnitude of PK effects is unlikely to be of clinical relevance based on Phase 2 and 3 clinical experience with fesoterodine , supporting its administration without regard to meals .\
\
###23040001\
BACKGROUND	It has been ascertained that triple-negative ( TN ) breast cancer is characterized by an aggressive clinical course and a poor prognosis .\
BACKGROUND	The purpose of our study was to compare the magnetic resonance imaging ( MRI ) features of the 3 major different breast cancer subtypes ( TN , luminal , and human epidermal growth factor receptor 2 [ HER2 ] - overexpressing ) and to suggest the criteria that might predict TN phenotype .\
METHODS	From October 2007 to April 2011 , we studied 77 patients with histologically confirmed TN breast cancer who underwent breast MRI .\
METHODS	We randomly included 148 patients with non-TN breast cancer ( 110 luminal and 38 HER-overexpressing ) as a control group .\
METHODS	We evaluated the clinicopathologic data , the MRI morphologic and kinetic features , the signal intensity on T2-weighted images , and the apparent diffusion coefficient ( ADC ) .\
RESULTS	Our results confirmed that TN tumors are more aggressive , are usually diagnosed at a younger age compared with the other study groups , and show benign morphologic features with MRI .\
RESULTS	Backward stepwise logistic regression identified some parameters as independent predictors of TN-type lesions : age , size , shape , presence of edema , and infiltrative characteristics .\
RESULTS	The receiver operating characteristic ( ROC ) curve , built with 4 of 5 these factors as criteria to predict TN status , showed a 0.664 area under the curve ( AUC ) value ( sensitivity 58.4 % , specificity 73.2 % ) .\
RESULTS	The inclusion of the fifth criterion showed a 0.699 AUC value ( sensitivity , 49.4 % ; specificity , 89.4 % ) .\
CONCLUSIONS	We identified the clinicoradiologic parameters that are independent predictors of TN breast lesions , which might be helpful for earlier prediction of the TN status of a breast lesion .\
\
###10622160\
OBJECTIVE	To identify the lowest single dose of lufenuron injected s.c. that results in a 90 % disruption of the flea ( Ctenocephalides felis ) life cycle for 6 months in cats .\
METHODS	40 domestic shorthair cats ( 20 males , 20 females ) between 5 and 7 months old .\
METHODS	Cats were randomly assigned to 1 of 5 eight-cat groups and experimentally infested with C. felis on days -8 , -7 , -6 , and -4 .\
METHODS	On day 0 , cats in the 4 treatment groups were treated with an injectable formulation of lufenuron at doses of 2.5 , 5 , 10 , or 20 mg/kg of body weight , respectively .\
METHODS	Control cats received the injectable formulation without lufenuron .\
METHODS	Experimental infestations were repeated and flea eggs collected at various intervals for 196 days after treatment .\
METHODS	Eggs were placed in media and incubated in an insectary for 28 days to determine effects of injectable lufenuron on egg and larval development .\
METHODS	Number of adults that emerged from eggs were compared among groups .\
RESULTS	Lufenuron injected once at a dose of 10 or 20 mg/kg , but not at 2.5 or 5 mg/kg , resulted in a 90 % decrease in number of adult fleas emerging from eggs for 196 days after treatment .\
CONCLUSIONS	Results indicate that control of flea egg and larval development for at least 6 months can be achieved in cats with a single s.c. injection of lufenuron ( 10 mg/kg ) .\
CONCLUSIONS	The injectable formulation may provide veterinarians and cat owners an alternative to the tablet formulation of lufenuron .\
\
###20691408\
OBJECTIVE	To compare eclampsia and magnesium toxicity management among residents randomly assigned to lecture or simulation-based education .\
METHODS	Statified by year , residents ( n = 38 ) were randomly assigned to 3 educational intervention groups : SimulationLecture , Simulation , and Lecture .\
METHODS	Postintervention simulations were performed for all and scored using standardized lists .\
METHODS	Maternal , fetal , eclampsia management , and magnesium toxcity scores were assigned .\
METHODS	Mann-Whitney U , Wilcoxon rank sum and ( 2 ) tests were used for analysis .\
RESULTS	Postintervention maternal ( 16 and 15 vs 12 ; P < .05 ) and eclampsia ( 19 vs 16 ; P < .05 ) scores were significantly better in simulation based compared with lecture groups .\
RESULTS	Postintervention magnesium toxcitiy and fetal scores were not different among groups .\
RESULTS	Lecture added to simulation did not lead to incremental benefit when eclampsia scores were compared between SimulationLecture and Simulation ( 19 vs 19 ; P = nonsignificant ) .\
CONCLUSIONS	Simulation training is superior to traditional lecture alone for teaching crucial skills for the optimal management of both eclampsia and magnesium toxicity , 2 life-threatening obstetric emergencies .\
\
###23388004\
BACKGROUND	There is a need for a simple and efficacious treatment for cutaneous leishmaniasis with an acceptable side-effect profile .\
METHODS	We conducted a randomized , vehicle-controlled phase 3 trial of topical treatments containing 15 % paromomycin , with and without 0.5 % gentamicin , for cutaneous leishmaniasis caused by Leishmania major in Tunisia .\
METHODS	We randomly assigned 375 patients with one to five ulcerative lesions from cutaneous leishmaniasis to receive a cream containing 15 % paromomycin-0 .5 % gentamicin ( called WR 279,396 ) , 15 % paromomycin alone , or vehicle control ( with the same base as the other two creams but containing neither paromomycin nor gentamicin ) .\
METHODS	Each lesion was treated once daily for 20 days .\
METHODS	The primary end point was the cure of the index lesion .\
METHODS	Cure was defined as at least 50 % reduction in the size of the index lesion by 42 days , complete reepithelialization by 98 days , and absence of relapse by the end of the trial ( 168 days ) .\
METHODS	Any withdrawal from the trial was considered a treatment failure .\
RESULTS	The rate of cure of the index lesion was 81 % ( 95 % confidence interval [ CI ] , 73 to 87 ) for paromomycin-gentamicin , 82 % ( 95 % CI , 74 to 87 ) for paromomycin alone , and 58 % ( 95 % CI , 50 to 67 ) for vehicle control ( P < 0.001 for each treatment group vs. the vehicle-control group ) .\
RESULTS	Cure of the index lesion was accompanied by cure of all other lesions except in five patients , one in each of the paromomycin groups and three in the vehicle-control group .\
RESULTS	Mild-to-moderate application-site reactions were more frequent in the paromomycin groups than in the vehicle-control group .\
CONCLUSIONS	This trial provides evidence of the efficacy of paromomycin-gentamicin and paromomycin alone for ulcerative L. major disease .\
CONCLUSIONS	( Funded by the Department of the Army ; ClinicalTrials.gov number , NCT00606580 . )\
\
###19945106\
BACKGROUND	Chinese calligraphy handwriting is the practice of traditional Chinese brush writing , researches found calligraphy had therapeutic effects on certain diseases , some authors argued that calligraphy might have relaxation effect .\
OBJECTIVE	This study was to compare the effects of calligraphy handwriting with those of progressive muscle relaxation and imagery training in Chinese Nasopharyngeal Carcinoma patients .\
METHODS	This study was a randomized controlled trial .\
METHODS	Two hundred and eighty-seven Nasopharyngeal Carcinoma patients were approached , ninety ( 31 % ) patients were recruited and randomized to one of the three treatment groups : progressive muscle relaxation and guided imagery training group , Calligraphy handwriting group , or a Control group .\
METHODS	Seventy-nine ( 87.8 % ) completed all of the outcome measures .\
METHODS	The primary treatment outcome was the changes of physiological arousal parameters measured by pre - and post-treatment differences of heart rate , blood pressure and respiration rate .\
METHODS	The secondary outcomes included : modified Chinese version of Symptom Distress Scale , Profile of Mood State-Short Form , and Karnofsky Performance Status measured at baseline , during treatment ( after the 2-week intervention ) , post-treatment ( after the 4-week intervention ) and after a 2-week follow-up .\
METHODS	Effectiveness was tested by repeated measure ANOVA analyses .\
METHODS	Cancer centre of a major university hospital in Guangdong , China .\
RESULTS	Results showed that both of calligraphy and relaxation training demonstrated slow-down effects on physiological arousal parameters .\
RESULTS	Moreover , calligraphy practice gradually lowered participants ' systolic blood pressure ( simple main effect of time at pre-treatment measure , p = .007 ) and respiration rate ( p = .000 ) at pre - and post-treatment measures as the intervention proceeded , though with a smaller effect size as compared to relaxation .\
RESULTS	Both of calligraphy and relaxation training had certain symptom relief and mood improvement effects in NPC patients .\
RESULTS	Relaxation was effective in relieving symptom of insomnia ( p = .042 ) and improving mood disturbance , calligraphy elevated level of concentration ( p = .032 ) and improved mood disturbance .\
CONCLUSIONS	Similar to the effects of relaxation training , calligraphy demonstrated a gradually build-up physiological slow-down , and associated with heightened concentration and improved mood disturbance .\
CONCLUSIONS	Calligraphy offered a promising approach to improved health in cancer patients .\
\
###25675797\
OBJECTIVE	The aim of the study was to evaluate the safety and efficacy of early feeding after cesarean delivery under different anesthetic methods .\
METHODS	Two hundred women with elective cesarean delivery were randomly assigned to early oral feeding ( EOF ) or routine oral feeding ( ROF ) groups .\
METHODS	EOF patients were informed that they could begin taking fluids orally ( regime I ) as soon as 2 hours after the delivery and then gradually progress to solid foods ( regime III ) , if tolerated .\
METHODS	ROF patients were informed that they could start regime I right after bowel sounds were heard on examination and then gradually move on to regime III .\
METHODS	Hospitalization time and total time to ambulation ( primary outcomes ) , gasstool discharge time and onset of bowel sounds ( secondary outcomes ) were compared in groups A [ EOF patients after regional anesthesia ( n = 49 ) \} , B [ EOF patients after general anesthesia ( n = 48 ) \} , C [ ROF patients after regional anesthesia ( n = 47 ) \} and 0 [ ROF patients after general anesthesia ( n = 48 ) ] .\
RESULTS	There were significant differences in primary and secondary outcomes between group A and the remaining groups , especially group D.\
RESULTS	The status of patients from group B was not better than group C.\
RESULTS	In fact , the latter were discharged home sooner and passage of gas , as well as initiation of regime I occurred earlier as compared to the former\
CONCLUSIONS	Cesarean section under regional anesthesia and encouragement of oral feeding 2 hours after the operation should be recommended in order to acnieve postoperative recovery and early hospital discharge .\
CONCLUSIONS	Routine oral feeding ( right after bowel sounds are heard on examination ) after cesarean section under general anesthesia should be the last choice .\
\
###19124223\
OBJECTIVE	To describe the methodology of evaluating the response of cancer patients to interventions directed at lowering severity of multiple symptoms , and to compare two arms of a symptom management trial to determine factors associated with response and time to response .\
METHODS	Randomized trial comparing a nurse-assisted symptom management ( NASM ) cognitive-behavioral intervention with an automated telephone symptom management ( ATSM ) .\
METHODS	Patients in both arms received six intervention contacts over 8 weeks .\
METHODS	Analyses of the intervention contact data for 190 patients in NASM arm and 164 patients in the ATSM arm were conducted .\
METHODS	Severities of 15 cancer-related symptoms were assessed at each intervention contact , and an anchor-based definition of response was adopted .\
METHODS	Analyses were carried out using generalized estimating equations and Cox marginal proportional hazard models .\
RESULTS	When compared with patients in the NASM , patients in the ATSM had better response to manage anxiety , depression , poor appetite , cough , and fatigue .\
RESULTS	NASM was more successful in managing cancer pain .\
RESULTS	Response and time to response were associated with several patient and disease characteristics .\
CONCLUSIONS	The approach described here presents an analytic and clinical improvement over methods that examine each symptom separately or use summed scores of severity .\
\
###2215592\
BACKGROUND	In vitro fertilization , sometimes involving the cryopreservation of human embryos , has become a routine procedure for the treatment of infertility .\
BACKGROUND	Even though there are embryos available for transfer in about 85 percent of the treatment cycles , the rate of pregnancy rarely exceeds 25 percent per cycle .\
BACKGROUND	We designed this study to investigate two questions : Does this high rate of failure result from inadequate technique , or does it simply reflect the maximal potential of a cohort of aspirated eggs to produce a pregnancy ?\
BACKGROUND	And to what extent does cryopreservation affect the capacity for implantation of embryos ?\
METHODS	The study was conducted among patients enrolled in an egg-donation program .\
METHODS	Aspirated eggs from a given cohort were distributed to the donor herself and a few recipients .\
METHODS	The recipients were prepared by a standard protocol of hormone replacement and were assigned at random to the transfer of either fresh or frozen and thawed embryos .\
METHODS	The donors received only fresh embryos .\
RESULTS	Forty cycles of donation were studied .\
RESULTS	In 25 cycles ( 63 percent ) pregnancy was established in the donor , in the recipient ( or recipients ) , or in both .\
RESULTS	Of the fresh embryos that were transferred to the recipients , 24 percent were successfully implanted , as compared with only 7.7 percent of the frozen and thawed embryos ( P less than 0.01 ) .\
RESULTS	A pregnancy success rate of 37 percent per recipient cycle was observed in the recipients of fresh embryos , as compared with a rate of only 16 percent in those receiving frozen and thawed embryos ( P less than 0.05 ) .\
CONCLUSIONS	The majority of egg cohorts evidently possess the potential to produce a pregnancy , but cryopreservation of human embryos significantly reduces their capacity for implantation .\
\
###12869082\
OBJECTIVE	To evaluate the economic impact of celecoxib therapy vs. diclofenac plus omeprazole therapy for the treatment of arthritis in Chinese patients with a high risk of bleeding , from the perspective of a public health organization in Hong Kong .\
METHODS	The medical records of 287 Chinese arthritic patients with a history of bleeding ulcers who had previously participated in a randomised study of celecoxib 200 mg twice daily and extended-release diclofenac 75 mg twice daily plus 20 mg of omeprazole daily for 6 months were reviewed .\
RESULTS	Compared to the diclofenac plus omeprazole group , the average total direct cost per patient in the celecoxib group showed a significant reduction of 11 % , from HK 10,915 ( range HK dollars 10,915-57 ,899 ) to HK dollars 9714 ( range HK dollars 9714-89 ,770 ) ( P < 0.0001 ) ( 1 US dollars = 7.8 HK dollars ) .\
RESULTS	The median direct medical cost for routine management in the celecoxib group was significantly lower ( 11 % ) than that for the diclofenac plus omeprazole group [ HK dollars 10,915 ( range 10,915-28 ,048 ) vs. HK dollars 9714 ( range HK dollars 6946-26 ,179 ) ( P < 0.0001 ) ] .\
RESULTS	In patients who experienced recurrent bleeding , the celecoxib group showed a significantly higher median cost of management of recurrent bleeding than the diclofenac plus omeprazole group [ HK dollars 8466 ( range 572-29 ,851 ) vs. HK dollars 23,210 ( range HK dollars 12,318-65 ,823 ) ] ( P = 0.036 ) .\
CONCLUSIONS	Celecoxib therapy appears to cost less compared with diclofenac plus omeprazole for treatment of arthritis in Chinese patients with a high risk of bleeding .\
\
###16633098\
OBJECTIVE	To evaluate the effect of mosapride , a selective 5-hydroxytryptamine-4 agonist , on esophageal motility and bolus transit in asymptomatic volunteers .\
METHODS	Twenty healthy subjects participated in two experiments , 7 days apart , and we utilized a randomized , double-blind cross-over design with 3-day pretreatments of placebo or mosapride .\
METHODS	All subjects underwent combined intraluminal impedance manometry .\
RESULTS	There was no difference in the amplitude , the duration , and the esophageal peristaltic patterns between the two pretreatments .\
RESULTS	The lower esophageal sphincter ( LES ) pressure and the number of transient LES relaxations did not change after mosapride vs. placebo .\
RESULTS	However , the rate of complete bolus transit in liquid swallows was higher with mosapride pretreatment ( 92.2 % ) than with placebo ( 84.6 % ; P < 0.01 ) .\
RESULTS	The total bolus transit time in all liquid swallows showed a tendency to shorten after mosapride treatment ( P = 0.06 ) .\
RESULTS	The liquid bolus transit became faster after mosapride , especially in manometrically ineffective liquid swallows ( P < 0.01 ) .\
RESULTS	The total bolus transit time for manometrically normal viscous swallows decreased after pretreatment with mosapride ( 7.7 seconds ; range , 6.8-9 .2 ) in comparison with placebo ( 8.1 seconds ; range , 7.1-11 .1 ; P < 0.05 ) .\
CONCLUSIONS	Mosapride increases the rate of complete bolus transit in the esophagus , and enhances esophageal bolus transit in asymptomatic volunteers .\
\
###8247917\
OBJECTIVE	To compare the efficacy of combination therapy with sustained-release diltiazem and hydrochlorothiazide ( DTZ SR-HCTZ ) with that of monotherapy with DTZ SR , HCTZ , or placebo in the treatment of essential hypertension ; and to determine whether the addition of a diuretic to diltiazem at apparent optimum doses of each agent significantly enhances their antihypertensive effects .\
METHODS	Multicenter , randomized , double-blind , placebo-controlled , parallel-group trial with a 6-week treatment phase .\
METHODS	Private and university-based clinics .\
METHODS	Subjects of either sex , ranging in age from 18-70 years , with a diagnosis of stable essential hypertension made from two consecutive weekly mean supine diastolic blood pressure ( DBP ) readings of 95 mm Hg or above to 110 mm Hg or less that varied 7 mm Hg or less after 4-6 weeks in the baseline phase .\
METHODS	Of the patients enrolled , 298 met the inclusion criteria .\
METHODS	Combination therapy with DTZ SR-HCTZ 120 mg-12 .5 mg , or monotherapy with DTZ SR 120 mg or HCTZ 12.5 mg , or placebo was administered twice daily .\
RESULTS	Combination therapy with DTZ SR-HCTZ lowered both supine DBP and SBP significantly ( p < 0.005 ) more than either single agent .\
RESULTS	The combination also lowered DBP and SBP significantly more than either monotherapy .\
RESULTS	During a 12-hour in-clinic monitoring period spanning a dosing interval , both the combination and DTZ SR therapies maintained efficacy , whereas the antihypertensive effects of HCTZ dissipated after 8 hours .\
RESULTS	Treatment-related adverse events for the combination and HCTZ were similar but slightly greater than those for DTZ SR and placebo .\
CONCLUSIONS	The addition of a diuretic to sustained-release diltiazem produced an enhanced antihypertensive effect compared with monotherapy with either individual agent .\
\
###21619980\
BACKGROUND	The Surgical Management of Arterial Revascularization Therapies trial was conceived to rigorously compare completeness of revascularization , clinical outcomes and resource utilization in unselected patients referred for elective , primary coronary artery bypass grafting randomly assigned to undergo off-pump ( OPCAB ) or conventional on-pump coronary artery bypass grafting using cardiopulmonary bypass ( CPB ) .\
BACKGROUND	The goal of this follow-up study was to compare long-term survival , graft patency , myocardial ischemia , and clinical outcomes among survivors who volunteered to return for clinical evaluation and imaging studies .\
METHODS	Two hundred unselected patients with multivessel coronary artery disease were randomly assigned to OPCAB or CPB coronary artery bypass grafting between March 2000 and August 2001 .\
METHODS	All-cause mortality was determined by individual patient contact and referencing the Social Security Death Master File .\
METHODS	Of 140 survivors , 87 volunteered to return after a minimum of 6.8 years ( maximum , 8.4 years ; mean , 7.5 years ) for assessment of graft patency ( computed tomographic angiography ) and myocardial ischemia ( cardiac positron emission tomography and 12-lead electrocardiogram ) .\
METHODS	Age at follow-up ranged from 38 to 90 years ( mean , 68 years ) .\
RESULTS	There were 26 deaths from all causes among OPCAB patients and 31 among CPB patients as of March 30 , 2009 .\
RESULTS	Graft patency was similar between groups among 622 grafts assessed by angiography before hospital discharge ( 99 % OPCAB versus 97.7 % CPB ; p = 0.22 , Fisher 's exact test ) , among 511 grafts assessed by angiography at 1 year ( 93.6 % OPCAB versus 95.8 % CPB ; p = 0.33 ) , and among 190 grafts assessed by computed tomographic angiography at late follow-up ( 76 % OPCAB versus 83.5 % CPB ; p = 0.44 ) .\
RESULTS	Twelve of 34 OPCAB ( 35.3 % ) and 16 of 39 CPB patients ( 41.0 % ) had any ischemia on positron emission tomography scanning ( p = 0.62 ) .\
RESULTS	Four OPCAB patients ( 11.8 % ) and 9 CPB patients ( 23.1 % ) had an ischemic region in excess of 10 % of myocardium ( p = 0.21 ) .\
RESULTS	At late follow-up , recurrent angina had occurred in 11 of 43 ( 25.6 % ) OPCAB patients and 5 of 44 ( 11.4 % ) CPB patients ( p = 0.09 ) .\
RESULTS	Percutaneous reintervention had been performed at the discretion of blinded local cardiologists in 1 of 43 ( 2.3 % ) OPCAB patients and 1 of 44 ( 2.3 % ) CPB patients ( p = 1.0 ) .\
RESULTS	No patient in either group has undergone repeat CABG .\
CONCLUSIONS	In this randomized trial , off-pump and on-pump coronary artery bypass grafting were associated with similar early and late graft patency , incidence of recurrent or residual myocardial ischemia , need for reintervention , and long-term survival .\
\
###12571667\
OBJECTIVE	To assess the effect of phytoestrogens on bone turnover and growth in adolescent boys .\
METHODS	Randomized double-blind placebo-controlled trial .\
METHODS	Single school in northwest Tasmania .\
METHODS	Adolescent boys ( treatment n = 69 , placebo n = 59 , mean age 16.8 y ) .\
METHODS	Six weeks of isoflavone supplementation ( Novasoy , 50 mg daily of isoflavone equivalents ) .\
METHODS	Bone turnover markers ( bone specific alkaline phosphatase ( BAP ) and pyridinoline creatinine ratio ( PYR ) ) were measured at baseline and follow-up .\
RESULTS	Despite marked increases in urinary genistein and daidzein in the treatment arm ( both P < 0.001 ) , there were no significant differences in BAP , PYR or short-term height or weight change .\
RESULTS	This applied to both intention-to-treat and per protocol analysis .\
RESULTS	Neither was there a significant correlation between urinary genistein and daidzein levels and BAP or PYR .\
CONCLUSIONS	Phytoestrogen supplementation to the level of usual Japanese dietary intake has no measurable effect on bone turnover in adolescent boys .\
CONCLUSIONS	Longer-term studies of bone density may be desirable but it is unlikely that there will be a large effect in either girls or boys given the lower endogenous oestrogen levels in boys .\
\
###21498617\
OBJECTIVE	The present study tested the hypothesis that human choroidal blood flow ( ChBF ) regulation in the face of changes in ocular perfusion pressure ( OPP ) may be modified by a drug-induced decrease in intraocular pressure ( IOP ) .\
METHODS	This hypothesis was tested in a double-masked , randomized , placebo-controlled , parallel-group trial in 24 healthy volunteers .\
METHODS	OPP was manipulated by 6 minutes of squatting and a subsequent period of artificial increase in IOP induced with a suction cup .\
METHODS	These interventions were repeated after 14 days of treatment with either latanoprost or placebo .\
METHODS	ChBF was measured continuously with a portable laser Doppler flowmeter .\
RESULTS	As expected , latanoprost significantly reduced IOP compared with placebo ( P = 0.008 ) .\
RESULTS	The relative increases in OPP during squatting ( P = 0.97 ) and an artificial IOP increase ( P = 0.75 ) , however , were comparable after placebo and latanoprost .\
RESULTS	The response of ChBF was , in contrast , different between the two treatment groups .\
RESULTS	During the squatting-induced elevation of OPP , ChBF increased less after latanoprost than after placebo treatment ( P = 0.049 ) .\
RESULTS	During the suction cup-induced increase in IOP , the decrease in ChBF was less pronounced after latanoprost than after placebo ( P = 0.026 ) .\
RESULTS	Latanoprost , however , did not modify baseline ChBF at rest ( P = 0.30 ) .\
CONCLUSIONS	The data indicate that latanoprost improves ChBF regulation during both an increase and a decrease in OPP .\
CONCLUSIONS	Since latanoprost did not affect baseline ChBF , the authors assume that this effect is related to the decrease in IOP .\
CONCLUSIONS	This finding has important implications for understanding the relation between IOP and vascular factors in glaucoma , because it indicates that a reduction in IOP itself improves ChBF regulation .\
\
###17468524\
OBJECTIVE	To study the effects of human milk fortification on short term growth and biochemical parameters in preterm very low birth weight ( VLBW ) appropriate for gestation ( AGA ) and small for gestation ( SGA ) babies .\
METHODS	Prospective , randomized controlled trial .\
METHODS	Level III neonatal unit .\
METHODS	Preterm infants weighing < or = 1500 grams and < or = 34 weeks of gestation born between March 2001 to June 2002 .\
METHODS	Babies ( n = 166 ) were randomized in two groups either to get fortified human milk or exclusive human milk along with mineral and vitamin supplementation when feed volume reached 150 mL/Kg/day .\
METHODS	Fortification was done with a powdered fortifier added in expressed breast milk and continued till the baby reached 2 Kg or full breast feeds .\
METHODS	Primary outcome measures were Short-term growth ( daily weight , length and head circumference ( HC ) weekly ) till discharge or 2 Kg .\
RESULTS	Fortification ( n = 85 , birth weight 1202 g , gestation 30.8 wk ) resulted in better growth in preterm VLBW babies as compared to control group ( n = 81 , birth weight 1259 g , gestation 31.3 wk ) .\
RESULTS	Weight gain ( 15.1 and 12.9 g/kg/d , P < 0.001 ) , length ( 1.04 and 0.86 cm/week , P = 0.017 ) and HC ( 0.83 and 0.75 cm/week , P < 0.001 ) increased significantly in fortified group .\
RESULTS	SGA babies showed significant improvements in weight ( 16 g/Kg/d and 12.9 g/kg/d , P = 0.002 ) and length ( 1.09 cm/week and 0.92 cm/week , P = 0.042 ) in fortified group ( n = 38 ) as compared to control group ( n = 29 ) .\
RESULTS	In AGA subgroup , there was significant increase ( P = 0.006 ) in length ( 1 cm vs 0.82 cm ) in fortified group but no difference in weight ( P = 0.12 ) or HC ( P = 0.054 ) in fortified ( n = 47 ) vs control ( n = 52 ) group .\
RESULTS	Biochemical parameters were comparable , however feed intolerance was more in control group .\
CONCLUSIONS	Preterm VLBW babies showed better growth with human milk fortification .\
CONCLUSIONS	The effect is significant in SGA ( weight and length ) rather than AGA ( only length ) babies .\
\
###23485070\
OBJECTIVE	Tourniquet-related nerve injuries remain a concern in orthopedic surgery .\
OBJECTIVE	The cuff pressures used today are generally lower , and therefore a decreasing incidence of peripheral nerve injuries might also be expected .\
OBJECTIVE	However , there have been few neurophysiological studies describing the outcome after bloodless field surgery .\
OBJECTIVE	We describe the results of neurophysiological examinations and report the incidence of nerve injuries after total knee arthroplasty ( TKA ) in a bloodless field .\
METHODS	This study was part of a prospective , randomized controlled clinical trial in patients scheduled for TKA in a bloodless field .\
METHODS	20 consecutive patients were enrolled .\
METHODS	Electroneurography ( ENeG ) and quantitative sensory testing ( QST ) of thermal thresholds were performed on day 3 .\
METHODS	These tests were repeated 2 months after surgery when electromyography ( EMG ) with a concentric-needle electrode was also performed .\
RESULTS	The mean tourniquet cuff pressure was 237 ( SD 33 ) mmHg .\
RESULTS	Electromyographic signs of denervation were found in 1 patient , who also had the highest cuff pressure in the study population ( 294 mmHg ) .\
RESULTS	The sensory nerve response amplitudes were lower in the operated leg on day 3 ; otherwise , the neurophysiological examinations showed no differences between the legs .\
CONCLUSIONS	When low tourniquet cuff pressures are used the risk of nerve injury is minor .\
\
###12677011\
OBJECTIVE	The PROACT II study demonstrated a significant benefit from treatment with intra-arterial pro-urokinase ( r-proUK ) in patients with middle cerebral artery occlusion treated within 6 hours of stroke onset .\
OBJECTIVE	The purpose of the current study was to examine baseline factors to determine predictors of good outcome and response to treatment .\
METHODS	We selected from the baseline clinical , radiologic , and angiographic data variables that considered possibly related to outcome .\
METHODS	A univariate analysis was performed to examine the association between these baseline factors and good outcome , defined as a modified Rankin scale score < or = 2 .\
METHODS	A multivariate model then selected the most important variables independently influencing prognosis .\
METHODS	A risk score for each patient was constructed on the basis of the patient 's individual values for each independent variable .\
METHODS	Patients were stratified into risk quartiles based on their risk scores , and an odds ratio for each risk quartile was calculated .\
METHODS	The treatment effects of each quartile were compared .\
RESULTS	In the univariate analysis , screening National Institutes of Health stroke scale ( NIHSS ) score and age were strongly associated with good outcome .\
RESULTS	The multivariate model selected age , NIHSS score , and CT hypodensity as the most important prognostic variables .\
RESULTS	Dividing patients into quartiles based on risk scores achieved a uniform gradient of probability of good outcomes .\
RESULTS	A trend toward benefit of r-proUK treatment was seen in all risk quartiles , and no differential treatment effect was observed across risk groups .\
CONCLUSIONS	There was no evidence of differential effect of r-proUK across subgroups of patients stratified by risk .\
\
###22807627\
OBJECTIVE	To evaluate the effects of Tai chi exercise on balance , sleep quality , and cognitive performance in community-dwelling elderly in Vinh city , Vietnam .\
METHODS	A randomized controlled trial .\
METHODS	One hundred two subjects were recruited .\
METHODS	Subjects were divided randomly into two groups .\
METHODS	The Tai chi group was assigned 6 months ' Tai chi training .\
METHODS	The control group was instructed to maintain their routine daily activities .\
METHODS	The Falls Efficacy Scale ( FES ) , Pittsburgh Sleep Quality Index ( PSQI ) , and Trail Making Test ( TMT ) were used as primary outcome measures .\
RESULTS	Participants in the Tai chi group reported significant improvement in TMT ( part A ) ( F [ 1 , 71 ] = 78.37 , P < 0.001 ) and in TMT ( part B ) , ( F [ 1 , 71 ] = 175.00 , P < 0.001 ) in comparison with the control group .\
RESULTS	Tai chi participants also reported better scores in FES ( F [ 1 , 71 ] = 96.90 , P < 0.001 ) and in PSQI ( F [ 1,71 ] = 43.69 , P = 0.001 ) than the control group .\
CONCLUSIONS	Tai chi is beneficial to improve balance , sleep quality , and cognitive performance of the elderly .\
\
###1606094\
OBJECTIVE	The efficacy and safety of intravenous metoclopramide administered prophylactically before elective cesarean delivery under spinal anesthesia was studied .\
METHODS	In a double-blind , randomized fashion , 42 ASA Physical Status I-II parturients at term were assigned to receive either 10-mg intravenous metoclopramide or an equal volume of normal saline before induction of spinal anesthesia .\
METHODS	The occurrence of nausea and/or vomiting recorded throughout the perioperative period until the patient was admitted to the recovery room .\
METHODS	Neonatal acid-base status and neurobehavioral exams were obtained .\
RESULTS	Patients in the group receiving metoclopramide had a significantly lower incidence of nausea and vomiting both before and after delivery than the control group ( 14 % versus 81 % overall ) .\
RESULTS	All neonatal acid-base values were within normal limits and there were no significant differences in neurobehavioral exam results between the two groups .\
CONCLUSIONS	Metoclopramide administered before induction of spinal anesthesia for cesarean delivery appears to significantly reduce both pre - and postdelivery emetic symptoms without apparent adverse effects on mother or neonate .\
\
###19635338\
OBJECTIVE	To determine the effects of transcutaneous electrical nerve stimulation ( TENS ) and transcutaneous spinal electroanalgesia ( TSE ) on mechanical pain threshold ( MPT ) and vibration threshold ( VT ) .\
METHODS	A prospective , single-blind , randomised , placebo-controlled trial .\
METHODS	Laboratory based .\
METHODS	Thirty-four healthy volunteers ( 12 men and 22 women ; mean age + / - standard deviation 30 + / -8 years ) .\
METHODS	Exclusion criteria were conditions affecting upper limb sensation and contraindications to electrical stimulation .\
METHODS	Participants were allocated at random to receive TENS ( n = 8 ) , TSE ( n = 8 ) , placebo ( n = 9 ) or control ( n = 9 ) .\
METHODS	Electrical stimulation was applied for 30 minutes ( from time 18 minutes to 48 minutes ) via electrodes ( 5 cmx5 cm ) placed centrally above and below the space between the C6 and C7 spinous processes , with 5 cm between electrodes .\
METHODS	MPT ( using an algometer ) and VT ( using a vibrameter ) were recorded on seven occasions from the first dorsal interosseous muscle of the right hand - at baseline ( 0 minutes ) and then at 10-minute intervals until the end of the 60-minute testing period .\
RESULTS	There were no statistically significant group differences in MPT ( all p > 0.05 ) .\
RESULTS	Significant group differences in VT were found at 20 , 30 and 40 minutes ( all p < 0.05 ) .\
RESULTS	Post-hoc tests showed that the TENS group had significantly greater VT than both the placebo [ median difference 0.30 microm , 95 % confidence interval ( CI ) -0.05 to 0.66 ] and control ( 0.51 microm , 95 % CI 0.05 to 0.97 ) groups at 20 minutes , and significantly greater VT than the control group ( 0.69 microm , 95 % CI 0.20 to 1.17 ) at 30 minutes ( all p < 0.008 ) .\
CONCLUSIONS	Electrical stimulation did not alter MPT .\
CONCLUSIONS	The increase in VT during TENS may be due to distraction or antidromic block of large-diameter nerve fibres .\
CONCLUSIONS	TSE failed to alter either outcome measure significantly .\
\
###18447225\
OBJECTIVE	To observe analgesic effect of transcutaneous electrical acupoint stimulation combined with target-controlled infusion ( TCI ) in general anesthesia and effects on cardiovascular system .\
METHODS	Sixty selective breast operation patients were randomly divided into a combined group and a TCI group , 30 cases in each group .\
METHODS	The combined group received anesthesic induction for 30 min with transcutaneous electrical acupoint stimulation and then TCI into vein for general anesthesia , and the transcutaneous electrical acupoint stimulation was continued till the end of the operation .\
METHODS	The TCI group only received TCI irito vein for general anesthesia .\
METHODS	The target-controlled concentration of the general anesthesia drugs in plasma was monitored to evaluate the analgesic effect of transcutaneous electrical acupoint stimulation .\
METHODS	Meanwhile , the effects of the transcutaneous electrical acupoint stimulation on cardiovascular system were investigated .\
RESULTS	The mean Propofol and Fentany dosages needed were 226.67 mg and 0.11 mg in the combined group , and 272.22 mg and 0.14 mg in the TCI group during the operation , respectively , with significant differences ( P < 0.05 or P < 0.01 ) .\
RESULTS	The changes of heart rate and blood pressure in the combined group during skin-cutting were significantly less than those in the TCI group ( P < 0.05 ) .\
RESULTS	The awaking time in the combined group was significantly shortened .\
CONCLUSIONS	The transcutaneous electrical acupoint stimulation has a certain analgesic effect in the operation and can reduce 17 % Propofol dosage and 14 % Fentany dosage , and it can decrease the skin-cutting-induced stress reaction of the cardiovascular system and accelerate waking .\
\
###21679524\
BACKGROUND	One criticism of current video systems for endoscopic surgery is that two-dimensional ( 2D ) images lack depth perception and may impair surgical dissection .\
BACKGROUND	To objectively measure the efficacy of 3D endoscopy , we designed a training model with specific tasks to show potential differences between 2D and 3D endoscopy .\
BACKGROUND	Its clinical value was then evaluated during endoscopic sinus and skull base surgical cases .\
METHODS	Fifteen subjects were grouped according to endoscopic experience : novices and nonnovices .\
METHODS	A training model was constructed to include five tasks : incision manipulation ; ring transfer ; nerve hook ; distance estimation , visual only ; and distance estimation , visual and tactile .\
METHODS	Each participant was assessed with both a standard 2D endoscope and a 3D endoscope .\
METHODS	The clinical value of a 3D endoscope ( Visionsense , Ltd. , Petach Tikva , Israel ) was then examined in four endoscopic sinus cases and four skull base cases .\
RESULTS	Of the subjects , six ( 40 % ) were novices .\
RESULTS	Overall , the errors committed during any one task were not significantly different between systems .\
RESULTS	Novices trended toward more success during the nerve hook task using the 3D system .\
RESULTS	With size cueing versus visualization alone , distance estimation was significantly more accurate .\
RESULTS	Novices tended to prefer the 3D system and experienced surgeons disliked the initial learning curve .\
RESULTS	Advantages were particularly noticed during skull base surgery ; subjectively improved depth perception was beneficial during vascular dissection .\
CONCLUSIONS	Three-dimensional endoscopy may improve depth perception and performance for novices .\
CONCLUSIONS	The 3D endoscope is a safe and feasible tool for endoscopic sinus and skull base surgery ; it is promising for improving microneurosurgical dissection precision transnasally .\
\
###9793363\
BACKGROUND	Dissolution process in oral liquids by the presence of glass-ionomer systems ( due to surface corrosion , to diffusion through solutions and through mass ) make an ionic release ( particularly F , Al , Pb , As ) which is a non secondary problem , due to the usual utilization of these materials in pedodontic and restorative dentistry .\
METHODS	In this work , considering the high toxicity of low quantity of Arsenic ion , a comparative research has been made in order to determine , by using high level liquid Cromatography ( HPCL ) , the quantity in ppm of As hydro - and acid soluble given by five ionomeric products , in water and in nitric acid concentrated solution .\
CONCLUSIONS	The results show that in some products arsenical concentrations are higher then the quantity accepted by ISO-FDI ; therefore , a better control in the production of these products is needed as well as a limited use in dentistry .\
CONCLUSIONS	It is suggested to use glass-ionomer systems in patients with dental dike and varnish on the surfaces that are in contact with oral liquids action .\
\
###23276806\
OBJECTIVE	To compare efficacy , resistance development , and safety between rilpivirine and efavirenz in treatment-naive , HIV-1-infected adults with baseline viral load 100,000 copies/ml or less in the pooled 48-week dataset of the ECHO ( Efficacy Comparison in treatment-naive HIV-infected subjects Of TMC278 and EFV ) and THRIVE ( TMC278 against HIV , in a once-daily RegImen Vs. Efavirenz ) trials .\
METHODS	Phase III , double-blind , double-dummy , randomized trials .\
METHODS	Patients received rilpivirine 25mg once daily ( q.d. ) or efavirenz 600mg q.d. with two nucleoside/tide reverse transcriptase inhibitors [ N ( t ) RTIs ] .\
METHODS	This analysis considers the subpopulation of 368 rilpivirine and 330 efavirenz patients with baseline viral load 100,000 copies/ml or less .\
RESULTS	Significantly higher 48-week response rates ( viral load < 50 copies/ml , intent-to-treat-time-to-loss-of-virological response ) were observed with rilpivirine vs. efavirenz [ 90 vs. 84 % , respectively ; difference 6.6 % ( 95 % confidence interval 1.6-11 .5 % ) ] .\
RESULTS	The proportion of patients experiencing virological failure ( VF ( res ) ) was 5 % in each treatment group .\
RESULTS	A comparable proportion of VF ( res ) patients in each group developed nonnucleoside reverse transcriptase inhibitor resistance-associated mutations ( RAMs ) [ rilpivirine : 6/16 ( 38 % ) vs. efavirenz : 5/12 ( 42 % ) ] .\
RESULTS	A numerically higher proportion of rilpivirine VF ( res ) patients developed N ( t ) RTI RAMs [ 7/16 ( 44 % ) ] vs. efavirenz [ 2/12 ( 17 % ) ] ; P = 0.2232 .\
RESULTS	A significantly lower incidence for rilpivirine vs. efavirenz was observed for the following events : treatment-related grade 2-4 overall adverse events ( 17 vs. 30 % ; P < 0.0001 ) , rash ( any type ; 2 vs. 12 % ; P < 0.0001 ) , and neurological adverse events ( 19 vs. 40 % ; P < 0.0001 ) , including dizziness ( 10 vs. 29 % ; P < 0.0001 ) .\
RESULTS	There was no significant difference between groups in the total cholesterol/high-density lipoprotein cholesterol ratio .\
CONCLUSIONS	In treatment-naive patients with baseline viral load 100,000 copies/ml or less , rilpivirine along with two N ( t ) RTIs achieved a high response , with a comparable frequency of VF ( res ) and more favorable tolerability than efavirenz .\
\
###23680766\
OBJECTIVE	Globotriaosylceramide concentrations were assessed as potential predictors of change from baseline after 12 months by estimated glomerular filtration rate and left-ventricular mass index using pooled data from three randomized , placebo-controlled agalsidase alfa trials and open-label extensions of patients with Fabry disease .\
METHODS	Males ( aged 18 years or older ) with Fabry disease received agalsidase alfa ( 0.2 mg/kg every other week for 12 months ) .\
METHODS	A backward-elimination approach evaluated potential predictors ( baseline estimated glomerular filtration rate and left-ventricular mass index ; age at first dose ; baseline and change from baseline at 12 months of globotriaosylceramide ( urine , plasma ) ; urine protein excretion ; and systolic and diastolic blood pressure ) .\
METHODS	Subgroups included patients randomized to placebo or agalsidase alfa ( double-blind phase ) , then to agalsidase alfa ( open-label extensions ; placeboagalsidase alfa or agalsidase alfaagalsidase alfa , respectively ) and stage 2/3 chronic kidney disease patients .\
RESULTS	Baseline estimated glomerular filtration rate , age at first dose , baseline urine globotriaosylceramide excretion , and baseline and change from baseline urine protein excretion significantly predicted change from baseline estimated glomerular filtration rate in the analysis population ( N = 73 ; all P < 0.05 ) , although not in all subgroups .\
RESULTS	Change from baseline urine and plasma globotriaosylceramide ( baseline and change from baseline ) concentrations did not predict change from baseline estimated glomerular filtration rate .\
RESULTS	No predictors of left-ventricular mass index were significant .\
CONCLUSIONS	Changes in globotriaosylceramide concentrations do not appear to be useful biomarkers for prediction of Fabry disease-related changes in estimated glomerular filtration rate or left-ventricular mass index .\
\
###18049940\
OBJECTIVE	Equol , a gut bacterial metabolite of the isoflavone daidzein , has been associated with beneficial health effects .\
OBJECTIVE	Recent studies indicate that women with intestinal capacity to convert daidzein to equol also have the capacity to alter steroid metabolism and bioavailability of estrogens .\
METHODS	We evaluated whether individual equol production capability , while not consuming soy supplement , was associated with lower blood pressure in postmenopausal women using tibolone .\
METHODS	In addition , in a randomized , placebo-controlled , cross-over trial we assessed the effect of soy supplementation on blood pressure in both equol-producing ( n = 20 ) and non-equol-producing ( n = 20 ) women using tibolone .\
METHODS	Blood pressure was recorded with a validated oscillometric technique .\
RESULTS	The circulating equol levels rose 20-fold in the equol producers and 1.9-fold in the non-equol producers .\
RESULTS	At baseline , systolic blood pressure ( 129.9 + / - 2.6 vs. 138.5 + / - 3.1 mmHg , p = 0.02 ) , diastolic blood pressure ( 72.2 + / - 1.5 vs. 76.6 + / - 1.3 mmHg , p = 0.01 ) and mean arterial blood pressure ( 93.5 + / - 1.7 vs. 99.9 + / - 1.8 mmHg , p = 0.007 ) were lower in equol producers compared to non-equol producers .\
RESULTS	Soy supplementation had no effect on blood pressure in either group , whereas the baseline differences persisted .\
CONCLUSIONS	Postmenopausal women using tibolone characterized as equol producers had lower blood pressure compared to non-equol producers .\
CONCLUSIONS	Soy supplementation for 2 months had no blood pressure-lowering effect .\
\
###25388791\
OBJECTIVE	To evaluate the safety and feasibility of the da Vinci Surgical System in transoral robotic-assisted surgery for benign indications .\
METHODS	A multicenter , single-arm , retrospective case series .\
METHODS	Perioperative outcomes were recorded for patients presenting with obstructive sleep apnea , airway obstruction , lingual tonsillar/tonsillar/tongue base hypertrophy , or dysphagia who underwent one or more transoral procedures , including lingual tonsillectomy and tongue base resection ( partial glossectomy ) at one of three US institutions .\
RESULTS	Between January 2010 and October 2013 , 285 patients ( age 51.5 years , body mass index 30.5 kg/m ( 2 ) ) underwent 293 procedures .\
RESULTS	No conversions or blood transfusions were needed .\
RESULTS	The average operative time was 86.7 minutes , and the average volume of tissue resected ( lingual tonsil and tongue base ) was 8.3 mL .\
RESULTS	Hospital stays averaged 1.8 days , and the postoperative complication rate was 20.7 % .\
RESULTS	There were no complications specifically related to the use the da Vinci Surgical System , and none of the complications were life threatening .\
CONCLUSIONS	These results demonstrate that it is safe and feasible to use the da Vinci Surgical System to perform lingual tonsillectomy and base of tongue resection ( partial glossectomy ) procedures for benign indications .\
\
###20634175\
OBJECTIVE	To evaluate the efficacy and safety of initial combination therapy with metformin plus colesevelam in patients with early type 2 diabetes .\
METHODS	In this 16-week , randomized , double-blind , placebo-controlled study , adults with type 2 diabetes ( hemoglobin A1c [ A1C ] values of 6.5 % to 10.0 % ) and hypercholesterolemia ( low-density lipoprotein cholesterol [ LDL-C ] levels > or = 100 mg/dL ) were randomly assigned ( 1:1 ) to colesevelam ( 3.75 g/d ) or placebo in combination with open-label metformin ( 850 mg/d ; uptitrated at week 2 to 1,700 mg/d ) .\
METHODS	The primary efficacy evaluation was change in A1C from baseline to study end ( week 16 with last observation carried forward ) .\
RESULTS	In total , 286 patients were randomized : metformin/colesevelam ( n = 145 ) or metformin/placebo ( n = 141 ) .\
RESULTS	Mean A1C was reduced by 1.1 % with metformin/colesevelam ( from 7.8 % at baseline to 6.6 % at study end ) and by 0.8 % with metformin/placebo ( from 7.5 % to 6.7 % ) , resulting in a treatment difference of -0.3 % at study end ( P = .0035 ) .\
RESULTS	In addition , metformin/colesevelam significantly reduced LDL-C ( -16.3 % ) , total cholesterol ( -6.1 % ) , non-high-density lipoprotein cholesterol ( -8.3 % ) , apolipoprotein B ( -8.0 % ) , and high-sensitivity C-reactive protein ( -17 % ) and increased apolipoprotein A-I ( +4.4 % ) and triglycerides ( +18.6 % ) versus metformin/placebo ( P < .01 for all ) .\
RESULTS	The proportions of patients who achieved recommended goals with metformin/colesevelam versus metformin/placebo , respectively , were as follows : A1C < 7.0 % ( 67 % versus 56 % [ P = .0092 ] ) , LDL-C < 100 mg/dL ( 48 % versus 18 % [ P < .0001 ] ) , and composite A1C < 7.0 % + LDL-C < 100 mg/dL ( 40 % versus 12 % [ P < .0001 ] ) .\
RESULTS	Safety and tolerability were similar between the treatment groups .\
CONCLUSIONS	Metformin plus colesevelam may be a valid option for initial therapy to achieve glycemic and lipid goals safely in early type 2 diabetes .\
\
###18718816\
BACKGROUND	New cardiac rehabilitation ( CR ) programmes , such as home programmes using the Heart Manual , are being introduced but little is known about patients ' experiences of these .\
OBJECTIVE	To compare the views of patients who had completed a home or hospital-based CR programme and explore the benefits and problems of each programme .\
METHODS	16 patients from 4 hospital programmes attended one of 3 focus groups ; 10 home programme patients attended one of 2 focus groups .\
RESULTS	Some themes were common to all focus groups : loss of confidence ; continuing to exercise and lifestyle changes ; understanding of heart disease .\
RESULTS	Hospital programme patients particularly enjoyed exercising in a group and mixing with other people , and gained motivation and support from others .\
RESULTS	Home programme patients spoke very highly of the Heart Manual and valued the one-to-one support of the nurse facilitators .\
RESULTS	They described the home programme as a lifestyle change compared to the hospital programme which they suggested was more like a treatment .\
CONCLUSIONS	Patients in the hospital programme enjoyed the camaraderie of group exercise and patients in the home programme valued the wealth of information and advice in the Heart Manual and this gave them a feeling of being in control of their health .\
\
###20509919\
OBJECTIVE	Prolonged postoperative air leaks ( AL ) are a major cause of morbidity .\
OBJECTIVE	Aim of this work was evaluating use of a Lung Sealant System ( Pleuraseal , Covidien , Mansfield , MA , U.S.A. ) in pleural decortications for empyema thoracis .\
METHODS	From January 2008 to December 2008 , 46 consecutive patients received pleural decortications for empyema thoracis .\
METHODS	Post-procedural and malignancy-related empyemas were excluded .\
METHODS	After hydro-pneumatic test and surgical correction of AL ( until satisfaction ) , patients were assigned ( 23 per group ) to Control or Sealant group .\
METHODS	Control group underwent no additional interventions .\
METHODS	In Sealant group , lung sealant was applied over AL areas .\
METHODS	Following variables were measured daily : patients with AL ; time to chest drainage ( CD ) removal ; CD drainage volume at removal , postoperative length of hospital stay , postoperative C-reactive protein ( CRP ) , and leukocyte counts .\
METHODS	Personnel recording parameters were blinded to intervention .\
METHODS	Two-tailed t-tests ( normally distributed data ) or Mann - Whitney U-test ( not-normally distributed data ) were used for evaluating significance of differences between group means or medians .\
METHODS	Significance of any proportional differences in attributes were evaluated using Fisher 's Exact Test .\
METHODS	Statistical analysis was carried out using R-software ( version 2.8.1 ) .\
RESULTS	Groups were similar regarding demographic and baseline characteristics .\
RESULTS	No patients were withdrawn from study ; no adverse effects were recorded .\
RESULTS	There were no significative differences on CRP and leukocyte levels between two groups .\
RESULTS	Compared with the Control group , in Sealant group significantly fewer patients had AL ( 30 versus 78 % , p = 0.012 ) , and drains were inserted for a shorter time ( medians , 3 versus 5 days , p = 0.05 ) .\
RESULTS	Postoperative hospitalization time was shorter in Sealant group than in control group , but difference was not significant ( 0.7 days , p = 0.121 ) .\
CONCLUSIONS	Pleuraseal Lung Sealant System significantly reduces AL following pleural decortications for empyema and , despite of not-increased infectious indexes , is suitable for routinely use , even in procedures with contaminated pleura .\
\
###22991162\
OBJECTIVE	To examine the effects of an expressive writing intervention ( EWI ) on cancer-related distress , depressive symptoms , and mood in women treated for early stage breast cancer .\
METHODS	A nationwide sample of 507 Danish women who had recently completed treatment for primary breast cancer were randomly assigned to three 20-min home-based writing exercises , one week apart , focusing on either emotional disclosure ( EWI group ) or a non-emotional topic ( control group ) .\
METHODS	Cancer-related distress [ Impact of Event Scale ( IES ) ] , depressive symptoms ( Beck Depression Inventory-Short Form ) , and negative ( 37-item Profile of Moods State ) and positive mood ( Passive Positive Mood Scale ) were assessed at baseline and at 3 and 9 months post-intervention .\
METHODS	Choice of writing topic ( cancer versus other ) , alexithymia ( 20-item Toronto Alexithymia Scale ) , and social constraints ( Social Constraints Scale ) were included as possible moderators .\
RESULTS	Significant ( p < 0.01 ) group differences in mood change from before to immediately after each session suggested successful manipulation .\
RESULTS	Reductions over time in psychological symptoms were seen in both groups ( p < 0.05 ) , but no time group interactions were found .\
RESULTS	Choice of writing topic moderated effects on IES , with women writing about other themes showing greater reductions in cancer-related avoidance than women writing about their cancer .\
RESULTS	Fewer depressive symptoms and higher levels of positive mood were seen 3 months post-intervention in women writing about their cancer when compared with the control group .\
RESULTS	Difficulties describing feelings and externally oriented thinking ( 20-item Toronto Alexithymia Scale ) moderated effects on positive mood and IES-total , while no moderating effects were found of social constraints .\
CONCLUSIONS	In concordance with the majority of previous results with cancer patients , no main effects of EWI were found for cancer-related distress , depressive symptoms , and mood .\
CONCLUSIONS	Moderator analyses suggested that choice of writing topic and ability to process emotional experiences should be studied further .\
\
###22338468\
BACKGROUND	Procalcitonin ( PCT ) is a thyroid gland prohormone , and its serum concentration is elevated in systemic bacterial infections .\
BACKGROUND	The diagnostic cut-off value of PCT in patients early after cardiac surgery remains unclear .\
OBJECTIVE	We investigated whether procalcitonin-guidance could reduce antibiotic usage safely .\
METHODS	The prospective study included 205 patients who underwent open heart surgery .\
METHODS	The patients were randomly assigned for procalcitonin-guided antibiotic treatment ( PCT-group ; n = 102 ) or standard care ( standard group ; n = 103 ) .\
METHODS	On the basis of serum procalcitonin concentrations , usage of antibiotics was encouraged ( PCT > or = 0.5 ng/mL ) or discouraged .\
RESULTS	A relative risk of antibiotic exposure in the standard group compared with the PCT-group was 3.81 ( 95 % CI = 2.03-7 .17 ; p < 0.0001 ) .\
RESULTS	The mean cost of antibiotics per patient in procalcitonin group was Euro 193.3 + / - 636.6 vs. Euro 372.1 + / - 841.1 ( p = 0.206 ) in the standard group , while the mean cost per hospital day was Euro 8.0 + / - 18.4 vs. Euro 17.8 + / - 36.3 ( p = 0.028 ) .\
RESULTS	We found that non-infectious complications occurred in 40/102 vs. 41/103 ( p = 0.592 ) while infections appeared in 5/102 vs. 22/103 ( p = 0.001 ) cases .\
RESULTS	A statistically significant difference was observed in the treatment of urinary infections between PCT-group and standard group ; 1/102 vs. 9/103 ( p = 0.016 ) .\
RESULTS	In the PCT-group , the ICU stay was 5.74 + / - 11.49 days and in the standard group 6.97 + / - 11.61 ( p = 0.812 ) .\
RESULTS	The hospital stay was 12.08 + / - 11.28 vs. 12.93 + / - 10.73 ( p > 0.05 ) days , respectively .\
RESULTS	Mortality rates were equal in both groups of patients ( p = 0.537 ) .\
CONCLUSIONS	Procalcitonin-guided antibiotic treatment is safe and can significantly reduce the cost of postoperative care .\
CONCLUSIONS	Additionally , the antibiotic use during immediate postoperative course should be timely controlled and limited to documented bacterial infections .\
\
###20203165\
OBJECTIVE	Both larger molecule removal and dialyzer biocompatibility have been implicated in the high-flux hemodialysis ( HD ) - associated favorable outcome .\
OBJECTIVE	In an attempt to delineate the effect of membrane permeability , we performed a randomized , crossover study to compare the inflammatory biomarkers , lipid profile , and aortic pulse wave velocity ( PWV ) of two dialyzers that are composed of identical membranes but with different flux characteristics .\
METHODS	Stable patients who had anuria and were on low-flux polysulfone membrane were randomly allocated either to HD with high-flux polyamide membrane ( group A ; 22 patients ) or to HD with low-flux polyamide membrane ( group B ; 24 patients ) for 24 weeks , then they were started on 24 weeks of the alternative HD treatment .\
METHODS	Apart from the dialyzer , the dialysis prescription remained unchanged .\
RESULTS	Nineteen patients from group A and 23 patients from group B completed the study .\
RESULTS	Predialysis beta ( 2 ) - microglobulin levels decreased significantly when using the high-flux polyamide membrane .\
RESULTS	No difference between membranes was observed for serum albumin , high-sensitivity C-reactive protein , fibrinogen , IL-6 , triglycerides , HDL cholesterol , LDL cholesterol , and lipoprotein ( a ) during the study .\
RESULTS	A significant increase in aortic PWV , a marker of aortic stiffness , was noted after patients switched from high-flux to low-flux polyamide membranes .\
RESULTS	Similarly , the rate of change in aortic PWV was significantly decreased with the use of the high-flux polyamide membrane .\
CONCLUSIONS	Our findings suggest that dialysis with polyamide membranes with different flux characteristics did not modify the inflammatory indices and lipid profile in stable HD patients ; however , a seemingly beneficial effect on aortic stiffness was noted for patients who were maintained on high-flux polyamide membrane .\
\
###7568389\
OBJECTIVE	Measurements of the integrity of knee ligaments are used to diagnose injuries as well as to document the state of recovery .\
OBJECTIVE	Many factors , such as gender and experience of the examiner , are capable of influencing the reliability of such measurements .\
OBJECTIVE	The purpose of this study was to determine the effects on interrater reliability of measurements obtained using the KT-1000 arthrometer of experience , gender , and leg tested .\
METHODS	Two experienced examiners ( 1 male , 1 female ) and two inexperienced examiners ( 1 male , 1 female ) tested 22 subjects with unilateral anterior cruciate ligament ( ACL ) pathology .\
METHODS	The leg with an ACL injury and the uninjured leg of each subject were evaluated by all four examiners within one test session using 67-N , 89-N , maximum manual , and active anterior drawer tests .\
RESULTS	Greater anterior displacement values were found in the legs with ACL injury than in the uninjured legs .\
RESULTS	Reliability estimates , as assessed by intraclass correlation coefficients ( 2 , k ) and measurement error ( SEM ) , suggest that therapist experience may be a more important factor influencing reliability than gender .\
CONCLUSIONS	Given the magnitude of the errors obtained for tests routinely conducted in the clinic using the KT-1000 arthrometer , we recommend that repeated measurements should be taken by the same examiners whenever possible .\
CONCLUSIONS	[ Ballantyne BT , French AK , Heimsoth SL , et al. .\
CONCLUSIONS	Influence of examiner experience and gender on interrater reliability of KT-1000 arthrometer measurements .\
\
###25000668\
OBJECTIVE	To evaluate the clinical effect on plaque metabolism of a dentifrice containing 1.5 % arginine , an insoluble calcium compound and 1,450 ppm fluoride compared to a commercially available dentifrice containing 1,450 ppm fluoride in a silica base .\
METHODS	A 12-week , parallel , randomized , double-blind study using 48 subjects was conducted at the Colgate-Palmolive Technology Center ( Piscataway , NJ , USA ) .\
METHODS	One group used a test dentifrice containing 1.5 % arginine , an insoluble calcium compound and 1,450 ppm fluoride as sodium monofluorophosphate ( MFP ) , and the other group used a commercial silica dentifrice with 1,450 ppm fluoride as sodium fluoride ( NaF ) as a control .\
METHODS	Plaque metabolism analyses were conducted at baseline and after 2 , 4 , 6 , 8 , and 12 weeks of assigned product use .\
METHODS	The plaque analyses included pH measurements before and after a sucrose rinse , ammonia production and lactic acid production .\
RESULTS	Subjects using the test dentifrice had significantly higher plaque pH values before ( P < or = 0.01 ) and after ( P < or = 0.045 ) a sucrose challenge than those using the commercially available control dentifrice .\
RESULTS	Subjects using the test dentifrice also produced higher levels of ammonia and lower levels of lactic acid compared to subjects using the control dentifrice .\
\
###15016251\
OBJECTIVE	The aims of this study were to validate a randomized , split-mouth , localized experimental gingivitis model and to identify subjects with different gingivitis susceptibility .\
METHODS	In each of 96 healthy subjects , one maxillary quadrant was randomly assigned as `` test '' ( experimental gingivitis ) and the contralateral quadrant as `` control '' .\
METHODS	Plaque index ( PlI ) , gingival index ( GI ) , gingival crevicular fluid volume ( GCF ) , and angulated bleeding score ( AngBS ) were recorded in both quadrants at days 0 , 7 , 14 , and 21 .\
METHODS	Cumulative plaque exposure ( CPE ) , i.e. PlI over time , was calculated .\
METHODS	Day-21 GCF was standardized according to CPE , and residuals of GCF on CPE were calculated .\
METHODS	Two subpopulations were then defined , based on upper and lower quartiles of GCF-residual distribution and were , respectively , identified as `` high-responder '' ( HR ; n = 24 ) and `` low-responder '' ( LR ; n = 24 ) .\
RESULTS	At test quadrants , all parameters significantly increased throughout the trial , while in control quadrants , PlI , GI , and AngBS remained low .\
RESULTS	Significant differences were noted between test and control quadrants on days 7 , 14 , and 21 for all parameters .\
RESULTS	Significant increases in GI , AngBS , and GCF were observed in test quadrants over the course of the study in both HR and LR groups .\
RESULTS	Significant differences were noted between HR and LR groups for all gingivitis parameters on day 21 in test quadrants , without any significant differences in PlI or CPE between the groups .\
CONCLUSIONS	We identified two subpopulations characterized by significant differences in clinical parameters of plaque-induced gingival inflammation , despite similar amounts of plaque deposits and plaque accumulation rates .\
\
###9741505\
OBJECTIVE	The purpose of this study was to determine patient characteristics that are a priori predictors of early infarct related artery patency following thrombolytic therapy , and to provide a paradigm which may identify patients who would be most likely to achieve restoration of normal ( TIMI 3 ) coronary flow in response to thrombolytic therapy .\
BACKGROUND	Restoration of infarct-related artery perfusion in acute myocardial infarction is necessary for preservation of ventricular function and mortality reduction .\
BACKGROUND	Clinical variables that are a priori predictors of early patency with currently available thrombolytic regimens have not been fully characterized .\
METHODS	The probability of early infarct-related artery patency ( TIMI 3 flow ) was determined by multivariable logistic regression .\
METHODS	We determined a reduced ( parsimonious ) model for predicting early ( 90 min ) infarct-related artery patency ( TIMI grade 3 ) based on data from 1,030 patients in the GUSTO-I Angiographic study .\
RESULTS	Predictors of 90 min TIMI 3 flow are use of an accelerated t-PA regimen ( vs. streptokinase containing regimens ) ( chi2 = 39.1 ; p < or = 0.0001 ) , infarct related artery ( RCA/Lcx vs. LAD ) ( chi2 = 12.7 ; p = 0.0004 ) , body weight ( chi2 = 10.3 ; p = 0.001 ) and history of smoking ( chi2 = 7.4 ; p = 0.007 ) .\
RESULTS	Time from symptom onset to treatment was not significant ( p = 0.71 ) .\
CONCLUSIONS	The efficacy of currently available thrombolytic regimens is chiefly dependent on choice of thrombolytic regimen , body weight , infarct-related coronary artery and smoking history .\
CONCLUSIONS	Clinical variables alone correctly predict a priori TIMI 3 flow in the infarct-related artery 64 % of the time .\
CONCLUSIONS	Patients with body weights greater than 85 kg are at a significant disadvantage with regard to achieving successful thrombolysis compared to those with lesser body weights .\
\
###23325525\
BACKGROUND	The multicenter PROTECT AF study ( Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation ) was conducted to determine whether percutaneous left atrial appendage closure with a filter device ( Watchman ) was noninferior to warfarin for stroke prevention in atrial fibrillation .\
RESULTS	Patients ( n = 707 ) with nonvalvular atrial fibrillation and at least 1 risk factor ( age > 75 years , hypertension , heart failure , diabetes , or prior stroke/transient ischemic attack ) were randomized to either the Watchman device ( n = 463 ) or continued warfarin ( n = 244 ) in a 2:1 ratio .\
RESULTS	After device implantation , warfarin was continued for 45 days , followed by clopidogrel for 4.5 months and lifelong aspirin .\
RESULTS	Study discontinuation rates were 15.3 % ( 71/463 ) and 22.5 % ( 55/244 ) for the Watchman and warfarin groups , respectively .\
RESULTS	The time in therapeutic range for the warfarin group was 66 % .\
RESULTS	The composite primary efficacy end point included stroke , systemic embolism , and cardiovascular death , and the primary analysis was by intention to treat .\
RESULTS	After 1588 patient-years of follow-up ( mean 2.31.1 years ) , the primary efficacy event rates were 3.0 % and 4.3 % ( percent per 100 patient-years ) in the Watchman and warfarin groups , respectively ( relative risk , 0.71 ; 95 % confidence interval , 0.44 % -1.30 % per year ) , which met the criteria for noninferiority ( probability of noninferiority > 0.999 ) .\
RESULTS	There were more primary safety events in the Watchman group ( 5.5 % per year ; 95 % confidence interval , 4.2 % -7.1 % per year ) than in the control group ( 3.6 % per year ; 95 % confidence interval , 2.2 % -5.3 % per year ; relative risk , 1.53 ; 95 % confidence interval , 0.95-2 .70 ) .\
CONCLUSIONS	The `` local '' strategy of left atrial appendage closure is noninferior to `` systemic '' anticoagulation with warfarin .\
CONCLUSIONS	PROTECT AF has , for the first time , implicated the left atrial appendage in the pathogenesis of stroke in atrial fibrillation .\
BACKGROUND	: URL : http://www.clinicaltrials.gov .\
BACKGROUND	Unique identifier : NCT00129545 .\
\
###14510745\
BACKGROUND	Modern medical imaging modalities can trace labelled oral drug dosage forms in the gastrointestinal tract , and thus represent important tools for the evaluation of their in vivo performance .\
BACKGROUND	The application of gastric-retentive drug delivery systems to improve bioavailability and to avoid unwanted plasma peak concentrations of orally administered drugs is of special interest in clinical and pharmaceutical research .\
OBJECTIVE	To determine the influence of meal composition and timing of tablet administration on the intragastric performance of a gastric-retentive floating tablet using magnetic resonance imaging in the sitting position .\
METHODS	A tablet formulation was labelled with iron oxide particles as negative magnetic resonance contrast marker to allow the monitoring of the tablet position in the food-filled human stomach .\
METHODS	Labelled tablet was administered , together with three different solid meals , to volunteers seated in a 0.5-T open-configuration magnetic resonance system .\
METHODS	Volunteers were followed over a 4-h period .\
RESULTS	Labelled tablet was detectable in all subjects throughout the entire study .\
RESULTS	The tablet showed persistent good intragastric floating performance independent of meal composition .\
RESULTS	Unfavourable timing of tablet administration had a minor effect on the intragastric tablet residence time and floating performance .\
CONCLUSIONS	Magnetic resonance imaging can reliably monitor and analyse the in vivo performance of labelled gastric-retentive tablets in the human stomach .\
\
###18768369\
BACKGROUND	Mild cognitive impairments have been recorded in cross-sectional studies of women with breast cancer receiving endocrine treatment .\
BACKGROUND	More comprehensive studies were warranted because aromatase inhibitors are being used increasingly in both chemoprevention and adjuvant settings .\
BACKGROUND	We report findings from the cognitive subprotocol of the International Breast Intervention Study ( IBIS II ) , a double-blind placebo-controlled trial of anastrozole in postmenopausal women at high risk of developing breast cancer .\
BACKGROUND	We aimed to study and compare the effect of anastrozole versus placebo on memory and attention in these women .\
METHODS	Between Jan 3 , 2003 , and Dec 21 , 2005 , participants were recruited into the cognitive subprotocol from five UK centres .\
METHODS	Cognitive assessments were done before randomisation , at 6 months , and at 24 months .\
METHODS	227 of 249 women approached completed a comprehensive set of standardised cognitive tasks at baseline and were randomly assigned to receive anastrozole ( 1 mg/day for 5 years ) or placebo .\
METHODS	Psychological morbidity , endocrine symptoms , and self-reported cognitive complaints were also measured .\
METHODS	The main outcomes were cognitive task scores at baseline , 6 months , and 24 months .\
METHODS	Analyses were done by intention to treat .\
METHODS	This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN31488319 .\
RESULTS	111 women were assigned to anastrozole and 116 women to placebo .\
RESULTS	At 6 months , ten women in each group were excluded from analysis , leaving a total of 207 of 227 ( 91 % ) women available for further assessments .\
RESULTS	At 24 months , 24 women were excluded from the anastrozole group and 32 from the placebo group , leaving 151 of 227 ( 67 % ) women .\
RESULTS	We did not note any significant differences between the groups for any of the cognitive tasks .\
RESULTS	By 6 months , 13 women in both groups reported changes to their memory and this had decreased to five women in the placebo group and three women in the anastrozole group by the 24-month assessment .\
RESULTS	Significantly more women in the anastrozole group complained of hot flushes at 24 months ( 23 of 76 [ 30 % ] vs 11 of 73 [ 15 % ] , p = 0.032 , not corrected for multiple comparison ) , but this was the only difference in reported endocrine symptoms .\
CONCLUSIONS	These findings show little or no impairment of cognitive performance with the use of anastrozole compared with placebo in postmenopausal women at high risk of developing breast cancer who were able to tolerate endocrine-related side-effects .\
CONCLUSIONS	Future studies assessing cognition should be done within randomised trials with baseline assessments to ascertain the true extent of the putative effects that treatments for breast cancer might have on memory and attention .\
BACKGROUND	Cancer Research UK , London , UK ( grant numbers C6280/A3162 and C6280/A6764 ) .\
\
###25153249\
OBJECTIVE	To minimize stent-related symptoms , the proximal part of the Polaris stent is composed of a firm material and its distal part is composed of a soft material .\
OBJECTIVE	The aim of this study was to compare stent-related symptoms of Polaris and Percuflex stents and to assess the impacts of these stents on quality of life .\
METHODS	A total of 144 patients were randomized to a `` test '' group ( Polaris ; n = 64 ) or a `` conventional '' group ( Percuflex ; n = 80 ) at the time of ureteral stent insertion after ureteroscopic stone removal surgery .\
METHODS	Stents were allocated using a randomization program .\
METHODS	At 1 week postoperatively , patient symptoms were evaluated using the Ureteral Stent Symptom Questionnaire ( USSQ ) , and patients were asked complete a 10cm visual analogue scale ( VAS ) .\
METHODS	Mean scores for USSQ domains and mean VAS scores were compared .\
RESULTS	Mean patient age was 50.3 years , and the male-to-female ratio was 1:0.85 .\
RESULTS	No significant intergroup differences were found in the domain scores of urinary symptoms ( P = 0.58 ) , pain ( P = 0.87 ) , general health ( P = 0.20 ) , work ( P = 0.24 ) , sexual activity ( P = 0.64 ) , or additional problems ( P = 0.24 ) .\
RESULTS	In addition , VAS scores were nonsignificantly different ( P = 0.11 ) .\
RESULTS	Analysis of USSQ item scores , however , revealed the test group had better results for `` presence of pain , '' `` frequency of pain killer use , '' `` difficulties with respect to hard physical activity , '' `` fatigue , '' `` frequency of rest , '' `` stent-related impact on work , '' `` antibiotics use '' than the conventional group except for `` outpatient department visits '' .\
CONCLUSIONS	Compared with the conventional Percuflex ureteral stent , the new Polaris ureteral stent with a soft tail was not found to offer significant advantages in terms of voiding symptoms , pain , general health , sexual matters , or additional problems as determined by the USSQ or in VAS determined pain .\
CONCLUSIONS	Sub-analysis , however , showed that the Polaris has some advantages with respect to pain , physical activities , impact on work , and additional problems .\
CONCLUSIONS	Accordingly , the soft-tipped Polaris stent was found to have some clinical advantages over the conventional Percuflex stent .\
\
###15243523\
BACKGROUND	Investigations into tanners ' reasons for tanning have focused primarily on the perception of improved appearance .\
BACKGROUND	Reported relaxing effects of tanning suggest the possibility of a physiologic effect of UV that drives tanning behavior .\
OBJECTIVE	We sought to determine if there is a physiologic reinforcing effect of UV exposure , separate from appearance motivation , that may contribute to tanning behavior .\
METHODS	We determined the reinforcing effect of UV light in a series of controlled , blinded , repeated-choice trials of UV carefully designed to separate as cleanly as possible reinforcing effects of UV exposure from other factors including perceived benefits of having a tan .\
METHODS	A total of 14 young adults who used tanning beds regularly were exposed to otherwise identical UV and non-UV tanning bed stimuli on Mondays and Wednesdays for 6 weeks .\
METHODS	On Fridays , participants had concurrent access to the two beds .\
METHODS	The primary dependent variable was the percentage of choice sessions during which more UV than non-UV tanning was chosen .\
RESULTS	In all , 12 participants chose additional tanning exposure on Fridays and , of these , 11 consistently used the UV bed for that exposure .\
RESULTS	Of the total 41 occasions when participants chose to tan on Friday , 39 sessions ( 95 % ) were for the UV bed and only two for the non-UV bed .\
RESULTS	A more relaxed and less tense mood was reported after UV exposure compared with after non-UV exposure ( P = .008 and P = .002 , respectively ) .\
CONCLUSIONS	When exposed to UV and non-UV under blinded conditions , frequent tanners can distinguish the two conditions and undertake further UV exposure , indicating that UV is a reinforcing stimulus .\
CONCLUSIONS	The relaxing and reinforcing effects of UV exposure contribute to tanning behavior in frequent tanners and should be explored in greater detail .\
\
###21167586\
OBJECTIVE	To more efficiently determine the subcritical crack growth ( SCG ) parameters of dental ceramics , the effects of stressing rate and choice of statistical regression model on estimates of SCG parameters were assessed .\
METHODS	Two dental ceramic materials , a veneering material having a single critical flaw population ( S ) and a framework material having partially concurrent flaw populations ( PC ) , were analyzed using constant stress-rate testing , or `` dynamic fatigue '' , with a variety of testing protocols .\
METHODS	For each material , 150 rectangular beam specimens were prepared and tested in four-point flexure according to ISO6872 and ASTM1368 .\
METHODS	A full-factorial study was conducted on the following factors : material , stress rate assumed vs. calculated , number of stress rates , and statistical regression method .\
RESULTS	The proportion of specimens for which the statistical models over-estimated reliability was not significantly different based on regression method for Material S ( P = 0.96 , power = 94 % ) and was significantly different based on regression method for Material PC ( P < 0.001 ) .\
RESULTS	The standard method resulted in SCG parameters , n and l nB , of 35.9 and -11.1 MPa ( 2 ) s for Material S and 12.4 and 9.61 MPa ( 2 ) s for Material PC , respectively .\
CONCLUSIONS	The method of calculation that uses only the median strength value at each stress rate provided the most robust SCG parameter estimates .\
CONCLUSIONS	Using only two stress rates resulted in fatigue parameters comparable to those estimated using four stress rates having the same range .\
CONCLUSIONS	The stress rate of each specimen can be assumed to be the target stress rate with negligible difference in SCG parameter estimates .\
\
###18087554\
OBJECTIVE	To evaluate the efficacy , safety and tolerance of Felodipine controlled release tablets and Felodipine controlled release tablets associated combination each with Metoprolol , Lisinopril or Hydrochlorothiazide in the 12 weeks treatment of mild to moderate essential hypertension in China .\
METHODS	Multicenter , random samples , and open study have been processed .\
RESULTS	( 1 ) After 12 weeks associated combination treatment of anti-hypertension , the percentages of the persons who had attained the target were 80.2 % of ITT group in Felodipine controlled release tablets associated combination with Hydrochlorothiazide , 74.1 % of ITT group in with Metoprolol , and 80.5 % of ITT group in with Lisinopril , respectively .\
RESULTS	( 2 ) Mean reductions of systolic/diastolic blood pressure from baseline were 16.8 / 10.6 mm Hg in combination with Hydrochlorothiazide , 16.6 / 10.7 mm Hg in combination with Metoprolol , and 18.0 / 12.8 mm Hg in combination with Lisinopril each .\
RESULTS	There was no significant difference among these three groups ( P > 0.05 ) .\
RESULTS	With the Felodipine controlled release tablets treatment alone , the mean reductions from baseline was 24.8 / 17.5 mm Hg .\
RESULTS	But in combination with Lisinopril , the blood pressure could lower more quickly , and then could reach the target more rapidly .\
RESULTS	( 3 ) In the ITT group , the drug compliance with Felodipine controlled release tablets was 97.7 % , with those in combination with Hydrochlorothiazide 89.8 % , with those in combination with Metoprolol 100.0 % , and with those in combination with Lisinopril 96.4 % .\
RESULTS	The main adverse event related to Felodipine was headache , and to Lisinopril was cough .\
CONCLUSIONS	Antihypertensive drug Felodipine controlled release tablets are good and effective .\
CONCLUSIONS	And Felodipine controlled release tablet associated combination each with Metoprolol , Lisinopril or Hydrochlorothiazide can make most patients reach the treatment target , with safety , good tolerance , and high compliance .\
\
###18261963\
BACKGROUND	Conflicting views exist according to the individual philosophy about various plate designs that can be used in anterior cervical discectomy and fusion ( ACDF ) to achieve clinical and radiological improvement within shortest time period .\
BACKGROUND	No prospective randomized study has ever been conducted to clarify the relationship between clinical outcomes , fusion rates , and the choice of plate ( static vs. dynamic design ) .\
OBJECTIVE	To compare the clinical and radiological outcomes of patients treated with one-level or multiple levels ACDF using cervical plates of dynamic ( slotted-holes ) versus static ( fixed-holes ) design .\
METHODS	Single masked , prospective , randomized study .\
METHODS	Over a 4-year period , 66 patients ( M : F = 37:29 ) had ACDF using either dynamic ( n = 33 ) or static ( n = 33 ) plates for intractable radiculopathy as the result of degenerative cervical spine disease .\
METHODS	Overall , 28 patients had single-level fusion and 38 had two or three levels fused .\
METHODS	Visual Analogue Pain scores ( VASs ) , Neck Disability Index ( NDI ) , and radiological criteria of established fusion .\
METHODS	The qualifying subjects were randomized to receive ACDF using either fixed-holes ( static ) or the slotted-holes ( dynamic ) anterior cervical plates .\
METHODS	Clinical and radiographic data were collected and analyzed .\
METHODS	Paired-sample t test was used to correlate clinical and radiological outcomes and General Linear Model Analysis of Variance ( GLM ANOVA ) with repeated measures was used to detect outcome differences between the two groups for single and multiple fusions .\
RESULTS	At a mean follow-up of 16 months ( range , 12-24 ) , 49 patients ( 73.7 % ) had clinical success and 56 ( 85 % ) showed radiological fusion .\
RESULTS	Although clinical success was a predictor of fusion ( p = .043 ) , the reverse was not true ( p = .61 ) .\
RESULTS	In single-level fusion , no statistical difference of outcome was observed between the two groups but multilevel fusions with dynamic plate showed significantly lower VAS and NDI than those with static plates ( p = .050 ) .\
CONCLUSIONS	Although clinical improvement is a good predictor of successful ACDF , radiological evidence of fusion alone is not reliable as a parameter of success .\
CONCLUSIONS	The design of plate does not affect the outcomes in single-level fusions but statistics indicate that multiple-level fusions may have better clinical outcome when a dynamic plate design is used .\
\
###22489522\
OBJECTIVE	To compare the clinical effect of thoracolumbar fractures between single-segment pedicle screw fixation approach for the gap of paravertebral muscles and double-segment pedicle screw fixation approach for the stripping of paravertebral muscles .\
METHODS	From September 2008 to January 2010 , 65 patients with incomplete compressed thoracolumbar fractures or burst thoracolumbar fractures with unilateral endplate injury were randomly divided into two groups .\
METHODS	Thirty patients were treated with single-segment pedicle screw fixation through the gap of paravertebral muscles ( treatment group ) .\
METHODS	Thirty-five patients were treated with double-segment pedicle screw fixation through the stripping of the paravertebral muscles ( control group ) .\
METHODS	All the internal fixations were taken out during 10-12 months after operation .\
METHODS	Operative time , perioperative blood loss volume and postoperative drainage volume were compared between two groups .\
METHODS	At final follow-up , the change of neurological ASIA grade were recorded ; and postoperative 5 days and final follow-up , compared Denis classification of lumbar and back pain between two groups ; and analyzed the sagittal index and compressibility of anterior border of vertebral body by X - ray lateral projection .\
RESULTS	All patients were follow-up from 14 to 22 months with an average of 18.3 months .\
RESULTS	No postoperative infection , secondary spinal cord injury was found .\
RESULTS	One case of control group occurred internal fixation breakage at the 11th month after operation and other internal fixation no loosening .\
RESULTS	There was no significant difference in operative time , the recovery of neurological function between the two groups ( P > 0.05 ) .\
RESULTS	Perioperative blood loss volume and postoperative drainage volume of treatment group was less than that of control group ( P < 0.01 ) .\
RESULTS	And in Denis classification of lumbar and back pain , the treatment group recovered more quickly , and the residual pain of lumbar and back was less than that of control group ( P < 0.01 ) .\
RESULTS	Postoperative posterior salient and compression of anterior border of vertebral body improved in two groups ( P < 0.01 ) , there was no significant difference in degree of improvement between two groups ( P > 0.05 ) ; but both loss existed at final follow-up ( P < 0.01 ) , there was no significant difference in loss of posterior salient between two groups ( P > 0.05 ) .\
RESULTS	In the treatment group , the loss of rectify of anterior border of vertebral body existed , but it was less than that of the control group .\
CONCLUSIONS	In the premise of strict controlling surgery indications , the treatment of thoracolumbar fractures with single-segment pedicle screw fixation through the gap of paraspinal muscles , can effectively recover the height of vertebral body and rectify posterior salient , and reduce the fixed segment .\
CONCLUSIONS	Compared with the traditional operative method of double-segment pedicle screw fixation through the stripping of paraspinal muscle , it can obviously reduce the operation wound and the bleeding , lessen the pain of lumbar and back .\
CONCLUSIONS	And the recent clinical effect is satisfied .\
\
###10952476\
OBJECTIVE	To compare the efficacy , safety and pharmacokinetics of a newly developed controlled-release suppository ( MSR ) with MS Contin tablets ( MSC ) in cancer patients with pain .\
METHODS	In a double-blind , randomised , two-way cross-over trial , 25 patients with cancer pain were selected with a morphine ( M ) demand of 30 mg every 12 h. Patients were divided into two groups .\
METHODS	Group 1 received active MSC ( 30 mg ) and placebo MSR , followed by placebo MSC and active MSR ( 30 mg ) each for a period of 5 days .\
METHODS	Group 2 started with active MSR and placebo MSC , followed by active MSC and placebo MSR , each for a period of 5 days .\
METHODS	Blood for determination of plasma concentration of morphine ( M ) and its 3 - and 6-glucuronides ( M3G , M6G ) was collected , and area under the plasma concentration-time curve ( AUC ) 0-12 h , peak plasma concentration ( Cmax ) , time to reach Cmax ( tmax ) , and CO and C12 of M , M6G and M3G were determined on day 5 and day 10 .\
METHODS	Intensity of pain experienced by each patient was assessed every 2 h on a 0-10 scale , while side effects and rescue medication were recorded .\
RESULTS	Twenty patients ( ten patients in each group ) completed the study .\
RESULTS	A pronounced inter-patient variability in plasma concentrations of M , M3G and M6G was observed after administration of both forms .\
RESULTS	Apart from the C0 and C12 , no significant differences in AUC0-12 h , tmax and Cmax of morphine between the rectal and oral route of administration were found .\
RESULTS	In the case of the metabolites , it was found that AUC0-12 h and Cmax of M6G , and AUC0-12 h , Cmax , C0 and C12 of M3G after rectal administration were significantly lower than after oral administration .\
RESULTS	However , apart from the tmax of M6G , none of the pharmacokinetic parameters of M , M6G or M3G met the criteria for bioequivalence .\
RESULTS	There were no significant ( P = 0.44 ) differences in pain intensity score between the oral and rectal forms within the two groups , regardless of the treatment sequence .\
RESULTS	No treatment differences in nausea , sedation or the demand on escape medication ( acetaminophen tablets ) between the rectal and oral forms were observed .\
CONCLUSIONS	The newly developed controlled-release M suppository is safe and effective and may be a useful alternative for oral morphine administration in patients with cancer pain .\
\
###21237227\
OBJECTIVE	There is increasing interest in identifying patients with chronic hepatitis C genotype 2 or 3 infection in whom it is possible to lower the burden of therapy while retaining high levels of efficacy .\
METHODS	Treatment-naive patients with chronic hepatitis C genotype 2/3 infection were randomized to receive peginterferon alfa-2b ( 1.5 g/kg/wk ) for 24weeks ( group A ) ; peginterferon alfa-2b ( 1.0 g/kg/wk ) for 24weeks ( group B ) ; or peginterferon alfa-2b ( 1.5 g/kg/wk ) for 16weeks ( group C ) , each in combination with weight-based ribavirin ( 800-1200mg / d ) .\
METHODS	The study population comprised two cohorts : the Hep-Net cohort enrolled in Germany and an International cohort enrolled at study sites throughout Europe and Asia .\
METHODS	The primary end point was sustained virological response ( SVR ) .\
RESULTS	The study included 682 patients ; 80.2 % had genotype 3 infection .\
RESULTS	In the intent-to-treat population , SVR rates were 66.5 % , 64.3 % , and 56.6 % in groups A , B , and C , and were similar in Asian and white patients .\
RESULTS	Treatment differences ( A vs. B and A vs. C ) failed to reach the predefined margin for noninferiority of -10 % ; and thus groups B and C failed to show noninferiority relative to group A. Among patients with undetectable HCV RNA at week 4 , SVR rates were 75.3 % , 75.9 % , and 72.4 % , respectively .\
RESULTS	Relapse rates were 17.8 % , 16.3 % , and 29.3 % , respectively .\
RESULTS	Treatment-emergent serious adverse events were highest in group A and lowest in group C , and adverse events leading to discontinuation were similar across treatment arms .\
CONCLUSIONS	For patients with chronic hepatitis C genotype 2/3 infection , 24weeks of peginterferon alfa-2b ( 1.5 g/kg/wk ) plus weight-based ribavirin remains a standard-of-care therapy ; however , treatment for 16weeks may be considered for patients with undetectable HCV RNA at week 4 of the treatment .\
\
###23744847\
OBJECTIVE	The choice of the prime solution for cardiopulmonary bypass can play an important role in limiting the effect on blood coagulation , but it is still unclear what the effect of colloids on blood coagulation is .\
OBJECTIVE	The aim of this study was to investigate the effect of synthetic colloids on blood loss and blood coagulation in patients after on-pump coronary artery bypass graft ( CABG ) procedures .\
METHODS	Sixty elective , on-pump CABG patients were randomly assigned to receive the prime solutions lactated Ringer 's solution combined with hydroxyethyl starch 130/0 .4 ( HES , 6 % Volulyte , Fresenius Kabi Nederland BV , Zeist , the Netherlands ) ( HES group ) or gelatin ( Gelofusin ( ) , B Braun Melsung AG , Melsungen , Germany ) ( Gelo group ) .\
METHODS	Blood loss was assessed using post-operative chest tube output ; secondary endpoints were number of blood component transfusions , routine coagulation test values and rotation thromboelastometry values ( Rotem ( ) delta , Pentapharm GmbH , Munich , Germany ) .\
RESULTS	Total post-operative chest tube output was 500 420 ml in the HES group versus 465 390 ml in the Gelo group ( p = 0.48 ) .\
RESULTS	No significant differences were observed in any of the routine coagulation tests values , thromboelastometry parameters or number of blood component transfusions between the groups .\
CONCLUSIONS	In this randomized , controlled trial of adults after on-pump CABG procedures , there was no significant difference in blood loss or blood coagulation between the HES group and the Gelo group .\
\
###25348573\
BACKGROUND	The efficacy , acceptability and tolerability of the new oral phosphate binder Lenziaren ( SBR759 ) were evaluated in a randomized parallel-group design study in 36 healthy cats ( n = 6 per group ) .\
BACKGROUND	Five groups were fed once daily with a commercial diet containing 0.2 % phosphorus ( `` standard diet '' ) into which was mixed Lenziaren at 0.25 , 0.5 , 1.0 or 2.0 g/day or no treatment ( control group ) daily for 30 days .\
BACKGROUND	A sixth group was fed a commercial diet containing lower amounts ( 0.12 % ) of phosphorus ( `` renal diet '' ) and no treatment .\
RESULTS	When compared to the control group , Lenziaren produced significant dose-related reductions in urine phosphate concentrations , urine phosphate excretion and fractional urinary phosphate excretion .\
RESULTS	Significant effects versus the control group were observed at the 0.5 , 1.0 and 2.0 g/day dosages .\
RESULTS	Lenziaren was well tolerated and was associated with higher food consumption and serum iron concentrations versus the control .\
RESULTS	When compared to the control group , the renal diet was associated with significantly lower urine phosphate concentrations and loss of body weight .\
RESULTS	Lenziaren had similar effects on urine phosphate concentrations compared to the renal diet , but was not associated with loss of body weight .\
CONCLUSIONS	Lenziaren was effective as an oral phosphate binder in cats fed with a standard diet containing 0.2 % phosphorus .\
CONCLUSIONS	The acceptability and tolerability were good .\
CONCLUSIONS	Dosages of 0.5-1 .0 g/cat per day are recommended for clinical testing in cats fed with a standard diet .\
\
###25428632\
BACKGROUND	The management of recurrent malignant pleural effusions ( MPE ) can be challenging .\
BACKGROUND	Various options are available , with the most efficacious and widely used being talc pleurodesis .\
BACKGROUND	Talc can either be applied via a chest drain in the form of slurry , or at medical thoracoscopy using poudrage .\
BACKGROUND	Current evidence regarding which method is most effective is conflicting and often methodologically flawed .\
BACKGROUND	The TAPPS trial is a suitably powered , multicentre , open-label , randomised controlled trial designed to compare the pleurodesis success rate of medical thoracoscopy and talc poudrage with chest drain insertion and talc slurry .\
METHODS	330 patients with a confirmed MPE requiring intervention will be recruited from UK hospitals .\
METHODS	Patients will be randomised ( 1:1 ) to undergo either small bore ( < 14Fr ) Seldinger chest drain insertion followed by instillation of sterile talc ( 4g ) , or to undergo medical thoracoscopy and simultaneous poudrage ( 4g ) .\
METHODS	The allocated procedure will be performed as an inpatient within 3days of randomisation taking place .\
METHODS	Following discharge , patients will be followed up at regular intervals for 6months .\
METHODS	The primary outcome measure is pleurodesis failure rates at 3months .\
METHODS	Pleurodesis failure is defined as the need for further pleural intervention for fluid management on the side of the trial intervention .\
BACKGROUND	The trial has received ethical approval from the National Research Ethics Service Committee North West-Preston ( 12/NW/0467 ) .\
BACKGROUND	There is a trial steering committee which includes independent members and a patient and public representative .\
BACKGROUND	The trial results will be published in a peer-reviewed journal and presented at international conferences , as well as being disseminated via local and national charities and patient groups .\
BACKGROUND	All participants who wish to know the study results will also be contacted directly on their publication .\
BACKGROUND	ISRCTN47845793 .\
\
###10506041\
OBJECTIVE	To determine the efficacy of antibacterial prophylaxis in preventing infectious complications after percutaneous endoscopic gastrostomy .\
METHODS	Prospective , randomised , placebo controlled , double blind , multicentre study .\
METHODS	Departments of internal medicine at six German hospitals .\
METHODS	Of 106 randomised adult patients with dysphagia , 97 received study medication , and 84 completed the study .\
METHODS	The median age of the patients was 65 years .\
METHODS	Most had dysphagia due to malignant disease ( 65 % ) , and many ( 76 % ) had serious comorbidity .\
METHODS	A single intravenous 2.2 g dose of co-amoxiclav or identical appearing saline was given 30 min before percutaneous endoscopic gastrostomy performed by the thread pull method .\
METHODS	Occurrence of peristomal wound infections and other infections within one week after percutaneous endoscopic gastrostomy .\
RESULTS	The incidence of peristomal and other infections within one week after percutaneous endoscopic gastrostomy was significantly reduced in the antibiotic group ( 8/41 ( 20 % ) v 28/43 ( 65 % ) , P < 0.001 ) .\
RESULTS	Similar results were obtained in an intention to treat analysis .\
RESULTS	Several peristomal wound infections were of minor clinical significance .\
RESULTS	After wound infections that required no or only local treatment were excluded from the analysis , antibiotic prophylaxis remained highly effective in reducing clinically important wound infections ( 1/41 ( 2 % ) v 11/43 ( 26 % ) , P < 0.01 ) and non-wound infections ( 2 ( 5 % ) v 9 ( 21 % ) , P < 0.05 ) .\
CONCLUSIONS	Antibiotic prophylaxis with a single dose of co-amoxiclav significantly reduces the risk of infectious complications after percutaneous endoscopic gastrostomy and should be recommended .\
\
###14652125\
OBJECTIVE	To investigate whether epidural analgesia with local anesthetics affects postoperative confusion in schizophrenic patients or the relationships between cortisol or interleukin-6 ( IL-6 ) and postoperative confusion .\
METHODS	Prospective , randomized study .\
METHODS	Hakodate Watanabe Hospital and Hirosaki National Hospital .\
METHODS	105 patients who were scheduled to undergo abdominal surgery with general anesthesia .\
METHODS	The schizophrenic patients were rendomly divided into two groups : patients in Group A received epidural anesthesia and patients in Group B did not receive epidural anesthesia .\
RESULTS	Postoperative confusion during the first 48 hours after the end of operation occurred in 7 of 33 patients ( 21 % ) in Group A and 10 of 33 patients ( 30 % ) in Group B.\
RESULTS	There were no significant differences in the frequency of postoperative confusion between Groups A and B. Plasma cortisol concentrations in schizophrenic patients in Group A were significantly lower 15 minutes after incision and the end of surgery than those levels of patients in Group B ; however , there was no significant difference between groups in plasma cortisol concentrations after anesthesia .\
RESULTS	Plasma IL-6 concentrations ( 51.7 + / - 22.0 and 31.4 + / - 8.2 pg mL ( -1 ) ) in patients with postoperative confusion at the end of surgery and 24 hours after surgery were significantly higher than those levels ( 34.4 + / - 16.2 and 16.9 + / - 7.7 pg mL ( -1 ) ) in patients without postoperative confusion .\
CONCLUSIONS	Epidural anesthesia does not significantly decrease the frequency of postoperative confusion in schizophrenic patients .\
CONCLUSIONS	Plasma IL-6 concentrations at the end of the operation and 24 hours after surgery in schizophrenic patients with postoperative confusion were significantly higher than those concentrations in patients without postoperative confusion .\
\
###17261383\
OBJECTIVE	The impact of interferon ( IFN ) treatment on the occurrence of complications related to hepatitis C virus ( HCV ) - related cirrhosis is debated because the majority of studies are retrospective .\
OBJECTIVE	We designed a randomized controlled trial comparing the efficacy of prolonged IFN alfa-2a treatment vs nontreatment on complication-free survival in patients with compensated HCV cirrhosis .\
METHODS	A total of 102 patients ( mean age , 60.5 + / - 9.5 y ; male/female ratio , .82 ) with biopsy examination-proven HCV cirrhosis , Child-Pugh score A , who were hepatocellular carcinoma ( HCC ) free , and had at least 1 risk factor of complications were randomized to receive IFN or no therapy for 24 months .\
RESULTS	During the follow-up evaluation , the complication rate was 24.5 % : HCC occurred in 12 and decompensation unrelated to HCC occurred in 13 patients .\
RESULTS	The number of HCC patients was similar in both groups .\
RESULTS	The probability of complication-free survival was not significantly different between treated and untreated patients ( 98 % and 72.3 % vs 90 % and 70.7 % at 12 and 24 mo , respectively , P = .59 ) .\
RESULTS	The median time until complication occurrence was 17.1 months in the treated group vs 13.6 months in the untreated group ( P = .2 ) .\
CONCLUSIONS	This randomized controlled trial showed that a 2-year course of IFN has little or no impact on complication-free survival in patients with high-risk compensated HCV cirrhosis .\
\
###22153890\
BACKGROUND	Studies with pertuzumab , a novel anti-HER2 antibody , show improved efficacy when combined with the established HER2-directed antibody trastuzumab in breast cancer therapy .\
BACKGROUND	We investigated the combination of pertuzumab or trastuzumab , or both , with docetaxel and the combination of pertuzumab and trastuzumab without chemotherapy in the neoadjuvant setting .\
METHODS	In this multicentre , open-label , phase 2 study , treatment-naive women with HER2-positive breast cancer were randomly assigned ( 1:1:1:1 ) centrally and stratified by operable , locally advanced , and inflammatory breast cancer , and by hormone receptor expression to receive four neoadjuvant cycles of : trastuzumab ( 8 mg/kg loading dose , followed by 6 mg/kg every 3 weeks ) plus docetaxel ( 75 mg/m ( 2 ) , escalating , if tolerated , to 100 mg/m ( 2 ) every 3 weeks ; group A ) or pertuzumab ( loading dose 840 mg , followed by 420 mg every 3 weeks ) and trastuzumab plus docetaxel ( group B ) or pertuzumab and trastuzumab ( group C ) or pertuzumab plus docetaxel ( group D ) .\
METHODS	The primary endpoint , examined in the intention-to-treat population , was pathological complete response in the breast .\
METHODS	Neither patients nor investigators were masked to treatment .\
METHODS	This study is registered with ClinicalTrials.gov , number NCT00545688 .\
RESULTS	Of 417 eligible patients , 107 were randomly assigned to group A , 107 to group B , 107 to group C , and 96 to group D. Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate ( 49 of 107 patients ; 458 % [ 95 % CI 361-557 ] ) compared with those given trastuzumab plus docetaxel ( group A ; 31 of 107 ; 290 % [ 206-385 ] ; p = 00141 ) .\
RESULTS	23 of 96 ( 240 % [ 158-337 ] ) women given pertuzumab plus docetaxel ( group D ) had a pathological complete response , as did 18 of 107 ( 168 % [ 103-253 ] ) given pertuzumab and trastuzumab ( group C ) .\
RESULTS	The most common adverse events of grade 3 or higher were neutropenia ( 61 of 107 women in group A , 48 of 107 in group B , one of 108 in group C , and 52 of 94 in group D ) , febrile neutropenia ( eight , nine , none , and seven , respectively ) , and leucopenia ( 13 , five , none , and seven , respectively ) .\
RESULTS	The number of serious adverse events was similar in groups A , B , and D ( 15-20 serious adverse events per group in 10-17 % of patients ) but lower in group C ( four serious adverse events in 4 % of patients ) .\
CONCLUSIONS	Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate compared with those given trastuzumab plus docetaxel , without substantial differences in tolerability .\
CONCLUSIONS	Pertuzumab and trastuzumab without chemotherapy eradicated tumours in a proportion of women and showed a favourable safety profile .\
CONCLUSIONS	These findings justify further exploration in adjuvant trials and support the neoadjuvant approach for accelerating drug assessment in early breast cancer .\
BACKGROUND	F Hoffmann-La Roche .\
\
###24937024\
OBJECTIVE	This study aims to evaluate the treatment effects of physical exercise on menopausal symptoms in middle-aged female medical staff experiencing perimenopausal syndrome .\
METHODS	A total of 157 female medical staff aged 40 to 55 years and with a Kupperman index score of 15 points or higher were randomized 1:1 into an intervention group ( n = 78 ) or a control group ( n = 79 ) .\
METHODS	Women in the intervention group were asked to perform aerobic physical exercise ( walking with strides ) three times a week or more , whereas those in the control group continued as normal .\
METHODS	Measurements were taken at baseline and on weeks 4 , 8 , and 12 , with total Kupperman index score , scores on individual elements of the scale , weight , and waist circumference recorded .\
METHODS	In addition , fasting blood glucose , triglycerides , total cholesterol , high-density lipoprotein cholesterol , and low-density lipoprotein cholesterol were recorded at baseline and on week 12 .\
METHODS	The effects of physical exercise therapy on perimenopausal syndrome were evaluated by comparing changes in these parameters between the control group and the intervention group .\
RESULTS	Fifty-four and 57 women completed all three follow-ups in the intervention and control groups , respectively .\
RESULTS	On week 12 , the mean ( SD ) change in total Kupperman index score ( -9.23 [ 6.23 ] ) from baseline to week 12 ; the mean ( SD ) changes in individual scores for paresthesia ( -1.08 [ 1.51 ] ) , insomnia ( -1.00 [ 1.46 ] ) , irritability ( -1.00 [ 1.34 ] ) , joint or muscle pain ( -0.75 [ 0.74 ] ) , fatigue ( -0.56 [ 0.75 ] ) , headache ( -0.54 [ 0.75 ] ) , formication ( -0.38 [ 0.66 ] ) , and sexual life ( -0.62 [ 1.71 ] ) ; and the mean ( SD ) changes in total cholesterol ( -0.76 [ 0.63 ] mmol/L ) and triglycerides ( -0.20 [ 0.50 ] mmol/L ) were significantly higher in the intervention group than in the control group ( P < 0.05 ) .\
RESULTS	In the intervention group , total Kupperman index score , weight , body mass index , waist circumference , triglycerides , and total cholesterol were significantly lower on week 12 compared with baseline ( P < 0.05 ) .\
CONCLUSIONS	Physical exercise can substantially reduce menopausal symptoms and improve blood lipid status and body weight .\
\
###11748394\
BACKGROUND	The addition of clonidine to local anesthetics has been shown to prolong both peripheral and central neuraxial local anesthetic blocks .\
BACKGROUND	Whether clonidine prolongs local anesthetic block by a pharmacokinetic effect or a pharmacodynamic effect is unclear .\
BACKGROUND	By directly measuring lidocaine tissue concentrations at the site of injection in the presence and absence of clonidine , this study was designed to address this question .\
METHODS	Microdialysis probes were placed adjacent to the superficial peroneal nerve in both feet of seven volunteers .\
METHODS	Plain lidocaine ( 1 % ) was injected along one nerve , and lidocaine with clonidine ( 10 microg/ml ) was injected along the other nerve in a double-blind , randomized manner .\
METHODS	The extracellular fluid was then sampled for lidocaine concentration at 5-min intervals using microdialysis , cutaneous blood flow was assessed by laser Doppler at 10-min intervals , and sensory block was assessed every 10 min until resolution .\
RESULTS	Consistent with previous studies , clonidine prolonged lidocaine sensory block .\
RESULTS	Blood flow increased in both groups but was significantly lower in the clonidine group , especially during the first 60 min .\
RESULTS	Consistent with the lower blood flow , the area under the lidocaine concentration-versus-time curve was significantly greater in the clonidine group during the first 60 min .\
CONCLUSIONS	When added to lidocaine , clonidine prolonged peripheral nerve block .\
CONCLUSIONS	The pharmacokinetic data suggest that the mechanism of prolongation is at least in part pharmacokinetic .\
\
###22097126\
OBJECTIVE	To observe the therapeutic effects of Pizhen in treating lumbar disc herniation combined with buttock tender node .\
METHODS	From August 2009 to February 2010,83 patients ( 29 males and 54 females ) with lumbar disc herniation combined with buttock tender node were randomly divided into the Pizhen group and acupuncture group .\
METHODS	Pizhen group were treated with Pizhen manipulation , inserting needle by vertical prick with quacking inserting and quick withdrawing the needle , no rotating and the depth was through the surface of fascia , two times as a course of treatment ; acupuncture group were treated with acupuncture , inserting Ashi-point , retaining the needle 20 min , ten times as a course of treatment .\
METHODS	VAS scoring at the end of treatment and B ultrasonic image at 3d after treatment was carried out to observe the therapeutic effects .\
RESULTS	B ultrasonic image of buttock tender node showed inflammation reaction or ellipse .\
RESULTS	The width of the inflammation reaction decreased after treatment , but there has no statistical significance ( P = 0.635 ) .\
RESULTS	There was no significant difference between two groups ( P = 0.813 ) .\
CONCLUSIONS	Pizhen manipulation is better than acupuncture .\
CONCLUSIONS	B ultrasonic image gives morphological performance of buttock tender node , the content is inflammatory infiltrates .\
CONCLUSIONS	B ultrasound has certainly significance in diagnosing , treating and evaluating the clinical effect of Pizhen manipulation on treating buttock tender node .\
\
###22469418\
OBJECTIVE	Epidemiologic studies indicate that soy intake has an important role in the prevention of age-related health problems .\
OBJECTIVE	Daidzein , the principal isoflavone contained in soy , is converted to S-equol by the intestinal bacteria .\
OBJECTIVE	Not all individuals , however , can produce S-equol , which is considered the most biologically active metabolite .\
OBJECTIVE	We studied the effects of a natural S-equol supplement on metabolic parameters associated with overweight or obesity and metabolic syndrome .\
METHODS	The study was a randomized , double-blinded , placebo-controlled , crossover design with no washout period .\
METHODS	All subjects were considered overweight or obese if they had a body mass index 25 kg/m ( 2 ) .\
METHODS	Placebo or natural S-equol tablets containing 10 mg S-equol were orally ingested each day for 12 weeks .\
METHODS	A total of 54 Japanese overweight or obese outpatients were enrolled .\
METHODS	The equol phenotype was determined , and various metabolic parameters , including cardio-ankle vascular index ( CAVI ) , were measured .\
RESULTS	Equol non-producers comprised 67.9 % of the overweight or obese subjects .\
RESULTS	The ratio of equol non-producers in this overweight or obese subject group was higher than the previously reported ratio of equol non-producers ( approximately 50 % ) in the general population .\
RESULTS	Compared with the placebo group , intervention with natural S-equol led to a significant decrease in HbA1c , serum low-density lipoprotein cholesterol ( LDL-C ) levels and CAVI score .\
RESULTS	Furthermore , the effect was more prominent in the subgroup of female equol non-producers .\
CONCLUSIONS	The ratio of equol non-producers in overweight or obese populations might be higher than generally reported .\
CONCLUSIONS	Natural S-equol might have a role in glycaemic control and in the prevention of cardiovascular disease by its effects to lower LDL-C levels and CAVI scores in overweight or obese individuals .\
\
###7729633\
OBJECTIVE	Anti-Helicobacter pylori treatment with combinations of omeprazole and amoxicillin is a promising treatment option .\
OBJECTIVE	The aim of this study was to investigate whether a daily omeprazole dose of 120 mg combined with amoxicillin would cure H. pylori infection at a rate comparable with that achieved with `` triple therapy . ''\
METHODS	In a double-blind , randomized , controlled , and multicenter trial in Germany , 270 patients with an H. pylori-associated duodenal ulcer were treated with 40 mg omeprazole three times a day and 750 mg amoxicillin three times a day for the first 14 days ( n = 139 ) followed by 20 mg omeprazole once daily until day 42 or with omeprazole plus 750 mg amoxicillin placebo three times a day for the same time period ( n = 131 ) .\
RESULTS	Cure rates of H. pylori infection were 91 % in the omeprazole plus amoxicillin group , 0 % in the omeprazole plus placebo group , and 89 % and 0 % , respectively , performing an intention-to-treat analysis .\
RESULTS	Cure of H. pylori infection in patients pretreated with omeprazole was only 58 % compared with 95 % in patients who were not .\
RESULTS	The cumulative 12-month relapse rates were 11.3 % and 44 % in the treatment groups and 1.6 % in H. pylori-negative and 49 % in H. pylori-positive patients .\
CONCLUSIONS	The combination of 120 mg omeprazole daily and 2.25 g amoxicillin daily with its H. pylori cure rate of around 90 % is one of the best tolerated and most effective treatment regimens .\
\
###8888803\
BACKGROUND	A joint study was performed by the Tokai HCFU study group , which included seven institutions , to examine the value of oral administration of Carmofur ( HCFU ) , a 5-fluorouracil ( 5-FU ) derivative , for postoperative adjuvant chemotherapy in patients with colorectal cancer undergoing curative resection .\
METHODS	The patients were divided into two groups , a control group receiving no HCFU and a group administered HCFU for 1 year , using a centralized registration system by telephone .\
METHODS	Among 173 patients entered into this study , 159 evaluable cases were analyzed for evaluation of the drug .\
RESULTS	The cumulative 5-year disease-free rate of patients who received HCFU was significantly increased compared with the control group .\
RESULTS	In particular , the rate was much higher in patients with colon cancer .\
RESULTS	No severe side effects arose from adjuvant chemotherapy with HCFU .\
CONCLUSIONS	Adjuvant chemotherapy with oral HCFU appears to provide a useful and safe postoperative treatment .\
\
###9741068\
BACKGROUND	This study was conducted to determine the efficacy and tolerability of fluoxetine and desipramine in treating depressive symptoms in women with cancer .\
METHODS	In this prospective , 6-week , double-blind , placebo-controlled trial , we compared fluoxetine with desipramine in treating depressive symptoms in 40 women diagnosed with cancer .\
METHODS	Scales used to measure efficacy and tolerability were the Hamilton Depression Rating Scale ( HAM-D ) , the Hamilton Anxiety Rating Scale ( HAM-A ) , the Clinical and Patient 's Global Impression ( CGI and PGI ) scales , the Functional Living Index for Cancer ( FLIC ) , the Memorial Pain Assessment Card ( MPAC ) , and the SF-36 Health Survey .\
RESULTS	Fluoxetine and desipramine treatments improved depression and anxiety symptoms .\
RESULTS	There was a trend towards significance in improvement of FLIC scores ( as evidenced by greater numerical improvements with fluoxetine treatment ) .\
RESULTS	Fluoxetine treatment alone was associated with statistically significant improvements in MPAC Mood scale scores .\
RESULTS	Both treatments showed statistically significant improvements in the quality of life SF-36 scores in Role Emotional , Social Functioning , Mental Health , and Vitality .\
CONCLUSIONS	Both fluoxetine and desipramine were effective and well-tolerated in improving depressive symptoms and quality of life in women with advanced cancer .\
CONCLUSIONS	Fluoxetine may offer greater benefit to these patients , as evidenced by greater improvements in fluoxetine-treated patients on several quality of life measures .\
CONCLUSIONS	Our results , while meaningful , should be confirmed in a larger patients sample .\
CONCLUSIONS	However , experience from studies of antidepressant use in patients with advanced cancer has shown that intercurrent disease and treatment variables make it difficult to conduct large studies .\
\
###21352670\
BACKGROUND	Treatment of bronchiectasis includes drugs , oxygen therapy , and bronchial-clearance maneuvers .\
OBJECTIVE	To assess the safety and efficacy of intrapulmonary percussive ventilation ( IPV ) compared to traditional standard chest physical therapy in patients with bronchiectasis and productive cough .\
METHODS	In a randomized crossover study , 22 patients underwent , on consecutive days , IPV and chest physical therapy .\
METHODS	Before each treatment session , immediately after the session , 30 min after the session , and 4 hours after the session we measured S ( pO ( 2 ) ) , heart rate , respiratory rate , and ( with a visual analog scale ) the patient 's subjective sensation of phlegm encumbrance and dyspnea .\
METHODS	Immediately after each treatment session we also measured ( via visual analog scale ) the patient 's discomfort .\
METHODS	We also measured the volume and wet and dry weight of collected sputum .\
RESULTS	No adverse effects were so severe as to require discontinuation of treatment , and the incidence of adverse effects was similar in the groups ( 27 % ) .\
RESULTS	Heart rate ( P = .002 ) and respiratory rate ( P = .047 ) decreased during treatment , and sensation of phlegm encumbrance improved ( P = .03 ) with both treatments .\
RESULTS	Only IPV improved ( P = .004 ) the sensation of dyspnea .\
RESULTS	The patients found IPV more comfortable than our traditional standard chest physical therapy ( P = .03 ) .\
RESULTS	Both treatments caused important phlegm production , but there were no differences in sputum volume , wet weight , or dry weight .\
CONCLUSIONS	In patients with bronchiectasis and productive cough , short-term IPV was as safe and effective as traditional chest physical therapy , with less discomfort .\
\
###11281512\
BACKGROUND	Cognitive impairment , the most important adverse effect of electroconvulsive therapy ( ECT ) , may involve elevated intracellular calcium ion signaling .\
BACKGROUND	Animal research suggests that calcium channel-blocking agents , which attenuate excessive intracellular calcium activity , may reduce cognitive dysfunction caused by ECT .\
METHODS	The lipid-soluble calcium channel-blocking drug nicardipine or matching placebo were randomly assigned to 26 patients with major depressive disorder receiving ECT .\
METHODS	A rater blind to the experimental condition administered the Hamilton Depression Rating Scale , the Montgomery-Asberg Depression Rating Scale , the Beck Depression Inventory , the Mini-Mental State Examination and a comprehensive battery of neuropsychological tests prior to ECT , at the completion of ECT , and 6 months after ECT completion .\
RESULTS	Compared with patients receiving placebo , patients taking nicardipine had significantly lower scores on the Hamilton and Montgomery-Asberg but not the Beck Depression rating scale scores at the completion of ECT .\
RESULTS	There were no differences between placebo and nicardipine groups in depression scores 6 months after ECT .\
RESULTS	Cognitive function declined over the course of ECT and improved over the next 6 months in both groups , but changes were statistically significant for only two subtests on the neuropsychological battery .\
RESULTS	Changes in Mini-Mental State Examination scores were small and were not significant at any point .\
RESULTS	There were no significant differences between nicardipine and placebo treated groups in any assessment of cognition .\
CONCLUSIONS	Standard approaches to ECT in younger patients without preexisting neurological impairment do not produce cognitive side effects of sufficient severity for calcium channel-blocking agents to reduce these side effects demonstrably .\
CONCLUSIONS	Studies of treatments for cognitive impairment should be conducted in patients with risk factors for more severe cognitive impairment such as geriatric patients or patients with a history of interictal delirium during previous treatment with ECT .\
CONCLUSIONS	A possible effect of nicardipine in enhancing the antidepressant action of ECT requires further investigation in a study designed to test this action .\
\
###20668532\
BACKGROUND	Emotional states linked to arousal and mood are known to affect the efficiency of cognitive performance .\
BACKGROUND	However , the extent to which memory processes may be affected by arousal , mood or their interaction is poorly understood .\
RESULTS	Following a study phase of abstract shapes , we altered the emotional state of participants by means of exposure to music that varied in both mood and arousal dimensions , leading to four different emotional states : ( i ) positive mood-high arousal ; ( ii ) positive mood-low arousal ; ( iii ) negative mood-high arousal ; ( iv ) negative mood-low arousal .\
RESULTS	Following the emotional induction , participants performed a memory recognition test .\
RESULTS	Critically , there was an interaction between mood and arousal on recognition performance .\
RESULTS	Memory was enhanced in the positive mood-high arousal and in the negative mood-low arousal states , relative to the other emotional conditions .\
CONCLUSIONS	Neither mood nor arousal alone but their interaction appears most critical to understanding the emotional enhancement of memory .\
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###16669846\
OBJECTIVE	To examine the effect of grapefruit juice , an inhibitor of CYP3A4 in the small intestine , on the disposition of manidipine enantiomers in healthy subjects .\
METHODS	A randomized cross-over study with at least a 2-week wash-out period was performed .\
METHODS	Seven healthy male volunteers received an oral 40-mg dose of racemic manidipine after an overnight fast with either grapefruit juice ( GFJ ) or water , as a control study .\
METHODS	Plasma concentrations of ( S ) - and ( R ) - manidipine were monitored up to 10 h after the dosing .\
RESULTS	The plasma concentrations of ( S ) - manidipine were significantly higher ( P < 0.001 ) than those of ( R ) - manidipine in the control phase with an S/R ratio for the AUC0-infinity of 1.62 ( 95 % confidence interval 1.52 , 1.73 ) .\
RESULTS	GFJ significantly increased Cmax and AUC0-infinity of ( S ) - manidipine by 2.4-fold ( P < 0.01 ) and 2.3-fold ( P < 0.01 ) , respectively , and Cmax and AUC0-infinity of ( R ) - manidipine were increased by 3.4-fold ( P < 0.01 ) and 3.0-fold ( P < 0.01 ) , respectively .\
RESULTS	There were significant differences ( P < 0.01 ) in GFJ-mediated percentage increases in Cmax and AUC0-infinity of ( S ) - manidipine compared with those of ( R ) - manidipine .\
RESULTS	The S/R ratio for AUC0-infinity was significantly decreased from 1.6 to 1.2 during the GFJ phase ( P < 0.01 ) .\
CONCLUSIONS	These results indicate that the stereoselective disposition of manidipine was altered by GFJ , as an inhibitor of CYP3A4 .\
CONCLUSIONS	GFJ appears to affect this metabolic disposal of ( R ) - manidipine to a greater extent than that of ( S ) - manidipine .\
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###12677608\
OBJECTIVE	Recently , a modified version of a successful soft drink has been developed that aims to reduce the potential for dental erosion in consumers .\
OBJECTIVE	The aim of this investigation was to compare the effect of the modified and original formula soft drink on the pH at various tooth surfaces during and after ingestion in subjects without erosion .\
METHODS	Fifteen subjects ( 10 female and 5 male ) without dental erosion drank both a modified and an unmodified beverage for over 5 minutes in a randomized order .\
METHODS	Oral pH was measured with antimony electrodes positioned on the labial and palatal surfaces of an incisor and premolar and held in place by a close-fitting vacuum-formed appliance .\
METHODS	The results were compared ( using the Wilcoxon signed rank test , with matched pairs ) for the percentage and total time that pH fell below 4 , 5 , and 5.5 .\
RESULTS	The percentage and total time that pH fell below 4 was significantly different between the drinks ( P < 0.02 ) , but the total time that pH fell below 5 and 5.5 was not .\
RESULTS	The time taken for subjects to return to pre-exposure pH levels in the mouth showed considerable variation between individuals .\
CONCLUSIONS	The modified-formula drink appeared to have less erosive potential than the original formula when assessed by measuring pH at the tooth surface .\
CONCLUSIONS	Although the erosive potential has been reduced by modifying the soft drink , it has not been eliminated .\
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###11911557\
BACKGROUND	Treatment guidelines for acute bacterial sinusitis recommend 10 to 14 days of therapy with amoxicillin/clavulanate , high-dose amoxicillin , cefpodoxime , cefuroxime , or a newer fluoroquinolone .\
OBJECTIVE	This study compared the clinical efficacy of short-course ( 5-day ) gatifloxacin with standard 10-day regimens of amoxicillin/clavulanate or gatifloxacin in patients with a diagnosis of acute , uncomplicated maxillary sinusitis .\
METHODS	This was a multicenter , investigator-blinded study in adult patients ( age > 18 years ) with physical findings , signs and symptoms ( for at least 7 days ) , and radiographic findings indicating acute , uncomplicated maxillary sinusitis .\
METHODS	Patients were randomized to receive gatifloxacin 400 mg once daily for 5 days , gatifloxacin 400 mg once daily for 10 days , or amoxicillin/clavulanate 875 mg twice daily for 10 days .\
METHODS	Clinical response was assessed once between days 3 and 5 of treatment , once I to 3 days after the completion of study treatment , once 7 to 14 days posttreatment ( test-of-cure visit ) , and once 21 to 28 days posttreatment .\
METHODS	Safety was assessed throughout the study .\
RESULTS	The study enrolled 445 patients .\
RESULTS	The treatment groups were similar in terms of history of sinusitis , presenting signs and symptoms , and radiographic findings .\
RESULTS	The most common presenting symptoms were nasal congestion , sinus tenderness , and purulent nasal discharge ( > 90 % of patients ) ; 99 % of patients had abnormal radiographic findings .\
RESULTS	At the test-of-cure visit , clinical cure rates for clinically evaluable patients in the 3 treatment groups were 74 % ( 102/137 ) for 5-day gatifloxacin , 80 % ( 101/127 ) for 10-day gatifloxacin , and 72 % ( 101 / 141 ) for 10-day amoxicillin/clavulanate ( 95 % CI for the difference in cure rates : 5-day gatifloxacin vs amoxicillin/clavulanate , -7.6 to 13.2 ; 5 - vs 10-day gatifloxacin , -15.2 to 5.1 ; 10-day gatifloxacin vs amoxicillin/clavulanate , -2.3 to 18.1 ) .\
RESULTS	The distribution and incidence of drug-related adverse events ( AEs ) were comparable between treatment groups , and the majority ( > 95 % ) were mild or moderate in severity .\
RESULTS	The most common drug-related AEs included vaginitis , diarrhea , and nausea .\
CONCLUSIONS	In this population of patients with acute , uncomplicated sinusitis of presumed bacterial origin , a short course ( 5 days ) of gatifloxacin therapy was associated with comparable clinical cure rates and tolerability to those of standard 10-day therapy with gatifloxacin or amoxicillin/clavulanate .\
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###20157663\
OBJECTIVE	This longitudinal randomized controlled clinical trial evaluated direct composite restorations for clinical acceptability as posterior restoratives in single - or multi-surface cavities and provides a survey of the 4-year results .\
METHODS	Three dentists placed 46 Quixfil ( Xeno III ) and 50 Tetric Ceram ( Syntac Classic ) composite restorations in stress-bearing Class I and II cavities in first or second molars ( 43 adult patients ) .\
METHODS	Clinical evaluation was performed at baseline and after 4 years by 2 other dentists using modified USPHS criteria .\
METHODS	At the last recall period , 37 Quixfil and 46 Tetric Ceram restorations were assessed .\
RESULTS	A total of 89.2 % of Quixfil and 97.8 % of Tetric Ceram posterior composites were assessed to be clinically excellent or acceptable with predominating alfa scores .\
RESULTS	Up to the 4-year recall , four Quixfil restorations failed because of bulk fracture , partial tooth fracture ( 2x ) and postoperative symptoms .\
RESULTS	One Tetric Ceram restoration was lost due to problems with tooth integrity .\
RESULTS	No significant differences between the two composites could be detected at 4 years for any of the evaluated clinical criteria ( p > 0.05 ) .\
RESULTS	The comparison of restoration performance with time within both groups yielded a significant increase in marginal discoloration and decrease in marginal integrity for both materials .\
RESULTS	After 4 years , small restorations exhibited significantly less marginal discoloration than large restorations .\
CONCLUSIONS	Clinical assessment of stress-bearing Quixfil and Tetric Ceram posterior composite restorations showed good clinical results with predominantly alfa scores for both materials .\
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###14668283\
BACKGROUND	We previously reported that maternal micronutrient supplementation in rural Nepal decreased low birth weight by approximately 15 % .\
OBJECTIVE	We examined the effect of daily maternal micronutrient supplementation on fetal loss and infant mortality .\
METHODS	The study was a double-blind , cluster-randomized , controlled trial among 4926 pregnant women and their 4130 infants in rural Nepal .\
METHODS	In addition to vitamin A ( 1000 microg retinol equivalents ) , the intervention groups received either folic acid ( FA ; 400 microg ) , FA + iron ( 60 mg ) , FA + iron + zinc ( 30 mg ) , or multiple micronutrients ( MNs ; the foregoing plus 10 microg vitamin D , 10 mg vitamin E , 1.6 mg thiamine , 1.8 mg riboflavin , 2.2 mg vitamin B-6 , 2.6 microg vitamin B-12 , 100 mg vitamin C , 64 microg vitamin K , 20 mg niacin , 2 mg Cu , and 100 mg Mg ) .\
METHODS	The control group received vitamin A only .\
RESULTS	None of the supplements reduced fetal loss .\
RESULTS	Compared with control infants , infants whose mothers received FA alone or with iron or iron + zinc had a consistent pattern of 15-20 % lower 3-mo mortality ; this pattern was not observed with MNs .\
RESULTS	The effect on mortality was restricted to preterm infants , among whom the relative risks ( RRs ) were 0.36 ( 95 % CI : 0.18 , 0.75 ) for FA , 0.53 ( 0.30 , 0.92 ) for FA + iron , 0.77 ( 0.45 , 1.32 ) for FA + iron + zinc , and 0.70 ( 0.41 , 1.17 ) for MNs .\
RESULTS	Among term infants , the RR for mortality was close to 1 for all supplements except MNs ( RR : 1.74 ; 95 % CI : 1.00 , 3.04 ) .\
CONCLUSIONS	Maternal micronutrient supplementation failed to reduce overall fetal loss or early infant mortality .\
CONCLUSIONS	Among preterm infants , FA alone or with iron reduced mortality in the first 3 mo of life .\
CONCLUSIONS	MNs may increase mortality risk among term infants , but this effect needs further evaluation .\
\
###23703687\
OBJECTIVE	Most of the 5.4 million Americans with dementia are cared for by family members who experience care needs and time constraints .\
OBJECTIVE	This quasi-experimental study examined the experience of using a psychosocial assessment instrument to understand caregiver needs delivered in an interview versus a self-administered web-based format .\
METHODS	Ten family caregivers were randomized to an interview group or a web-based group with two advanced practice registered nurses ( APRNs ) .\
METHODS	Surveys captured the caregivers ' and APRNs ' assessment experiences .\
RESULTS	There were no statistically significant differences between the two caregiver groups .\
RESULTS	Both groups rated the assessment instrument as excellent or good , finding it easy to complete capturing real needs they frequently denied or ignored .\
RESULTS	The APRN reported the web-based format was easier to use .\
CONCLUSIONS	Healthcare providers could use web-based caregiver assessment as an effective , efficient method for identifying care needs and planning interventions that promote balance/congruence in caregivers ' lives .\
\
###11465622\
BACKGROUND	The intubating laryngeal mask airway ( ILMA ; Fastrach ; Laryngeal Mask Company , Henley-on-Thames , UK ) may provide an alternative technique to fiberoptic intubation ( FIB ) to facilitate the management of the anticipated difficult airway .\
BACKGROUND	The authors therefore compared the effectiveness of the ILMA with FIB in patients with anticipated difficult intubation .\
METHODS	One hundred patients , with at least one difficult intubation criteria ( Mallampati class III or IV , thyromental distance < 65 mm , interincisor distance < 35 mm ) were enrolled ( FIB group , n = 49 ; ILMA group , n = 51 ) in this prospective randomized study .\
METHODS	Anesthesia was induced with propofol and maintained with alfentanil and propofol after an efficient mask ventilation has been demonstrated .\
METHODS	The success of the technique ( within three attempts ) , the number of attempts , duration of the successful attempt , and adverse events ( oxygen saturation < 90 % , bleeding ) were recorded .\
RESULTS	The rate of successful tracheal intubation with ILMA was 94 % and comparable with FIB ( 92 % ) .\
RESULTS	The number of attempts and the time to succeed were not significantly different between groups .\
RESULTS	In case of failure of the first technique , the alternative technique always succeeded .\
RESULTS	Failures in FIB group were related to oxygen desaturation ( oxygen saturation < 90 % ) and bleeding , and to previous cervical radiotherapy in the ILMA group .\
RESULTS	Adverse events occurred significantly more frequently in FIB group than in ILMA group ( 18 vs. 0 % , P < 0.05 ) .\
CONCLUSIONS	The authors obtained a high success rate and comparable duration of tracheal intubation with ILMA and FIB techniques .\
CONCLUSIONS	In patients with previous cervical radiotherapy , the use of ILMA can not be recommended .\
CONCLUSIONS	Nevertheless , the use of the ILMA was associated with fewer adverse events .\
\
###15992569\
OBJECTIVE	The primary objective was to conduct a detailed analysis of individual variation in psychological morbidity in the year following surgery for breast cancer .\
OBJECTIVE	The salience of the patients ' `` illness perceptions '' to morbidity was examined as a secondary objective .\
METHODS	Psychological morbidity was assessed with the General Health Questionnaire ( GHQ-28 ) in a prospective study of 371 women having surgery for primary breast cancer .\
METHODS	Patients also completed the Illness Perception Questionnaire ( IPQ ) , Mental Adjustment to Cancer Scale ( MAC ) and the Eysenck Personality Scales ( EPS ) .\
METHODS	Assessments were made postoperatively and at 3 , 6 and 12 months after surgery .\
RESULTS	Whilst descriptive statistics indicated a general reduction in mean distress over the 12-month follow-up , close analysis showed that a quarter of all patients maintained clinically significant levels of distress throughout the period .\
RESULTS	Patients with chronically elevated distress were characterised by higher levels of neuroticism , greater symptom awareness , more pain and poorer self-rated general health .\
RESULTS	In the regression analysis , psychological morbidity across the 1-year follow-up was predicted principally by the immediate postoperative state of distress , IPQ symptom awareness and the perceived time line of the illness , general health and , to a more minor extent , by neuroticism .\
CONCLUSIONS	There is marked individual variation in psychological morbidity in the year following breast cancer surgery , which is reliably predicted by the patient 's immediate postoperative state of distress , her perception of the impact of the symptoms and the time line of the disease .\
CONCLUSIONS	Subgroups of patients with chronically high distress are characterised by factors including personality and negative perceptions and beliefs about their illness .\
\
###18281099\
BACKGROUND	Neuropeptide Y ( NPY ) and serotonergic systems have been implicated in the pathophysiology of depression but have not yet been linked together .\
METHODS	In a randomized , double-blind crossover study , 28 medication-free patients with remitted depression and 26 healthy control subjects underwent tryptophan depletion ( TD ) and sham depletion .\
METHODS	Plasma NPY concentrations were determined at baseline and at +5 , +7 , and +24 h during TD and sham depletion , respectively .\
METHODS	Hamilton Depression Rating Scale ( HDRS , 24-item ) scores were assessed at baseline and at +7 and +24 h after TD and sham depletion , respectively .\
RESULTS	There was no difference between healthy subjects and patients with remitted depression in baseline plasma NPY concentrations and in plasma NPY concentrations during TD and sham depletion , respectively .\
RESULTS	Plasma NPY concentrations did not differ between TD and sham depletion .\
RESULTS	At no time point there was an association between HDRS scores and plasma NPY concentrations in patients with remitted depression .\
CONCLUSIONS	Plasma NPY concentrations in rMDD patients were not obtained during the symptomatic phase of the illness .\
CONCLUSIONS	Only peripheral measurements of NPY were used .\
CONCLUSIONS	Decreased plasma NPY concentrations , as described previously during a spontaneous episode of major depression , appear as state but not as trait marker in depression .\
CONCLUSIONS	No evidence was found for an involvement of plasma NPY in relapse during TD .\
CONCLUSIONS	There appears no direct functional link between serotonergic neurotransmission and plasma NPY concentrations .\
\
###12737857\
BACKGROUND	Although dietary fibre has been reported to have no association with colorectal adenoma and cancer , in some studies this topic remains controversial .\
METHODS	We used a 137-item food frequency questionnaire to assess the relation of fibre intake and frequency of colorectal adenoma .\
METHODS	The study was done within the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial , a randomised controlled trial designed to investigate methods for early detection of cancer .\
METHODS	In our analysis , we compared fibre intake of 33971 participants who were sigmoidoscopy-negative for polyps , with 3591 cases with at least one histologically verified adenoma in the distal large bowel ( ie , descending colon , sigmoid colon , or rectum ) .\
METHODS	Odds ratios were estimated by logistic regression analysis .\
RESULTS	High intakes of dietary fibre were associated with a lower risk of colorectal adenoma , after adjustment for potential dietary and non-dietary risk factors .\
RESULTS	Participants in the highest quintile of dietary fibre intake had a 27 % ( 95 % CI 14-38 , p ( trend ) = 0.002 ) lower risk of adenoma than those in the lowest quintile .\
RESULTS	The inverse association was strongest for fibre from grains and cereals and from fruits .\
RESULTS	Risks were similar for advanced and non-advanced adenoma .\
RESULTS	Risk of rectal adenoma was not significantly associated with fibre intake .\
CONCLUSIONS	Dietary fibre , particularly from grains , cereals , and fruits , was associated with decreased risk of distal colon adenoma .\
\
###12828083\
OBJECTIVE	The intravenous administration of interferon-beta may be effective for the treatment of chronic hepatitis C , as is intramuscular interferon-beta .\
OBJECTIVE	We compared the efficacy and safety of twice-a-day versus once-a-day of natural interferon-beta for the initial treatment of patients with chronic hepatitis C.\
METHODS	Forty-nine patients with chronic hepatitis C , with less than 5 Meq/mL serum hepatitis C virus-RNA , were randomly assigned into one of the two treatment groups A and B and treated with natural interferon-beta following two different protocols .\
METHODS	Twenty-two patients were treated with twice-a-day interferon-beta ( 3 MU ) for 3 weeks followed by once-a-day interferon-beta ( 6 MU ) for 5 weeks ( group A ) , and 20 patients were treated with once-a-day interferon-beta ( 6 MU ) for 8 weeks ( group B ) .\
METHODS	Seven patients did not complete the treatment protocol .\
METHODS	Efficacy was assessed by measuring the serum levels of hepatitis C virus-RNA and aminotransferase .\
RESULTS	The rate of sustained virological response was significantly higher in group A ( 14 of 22 patients , 63.6 % ) than in group B ( 6 of 20 patients , 30.0 % ) ( P < 0.05 ) .\
RESULTS	Among patients with hepatitis C virus-RNA level less than 1 Meq/mL , the sustained virological response rate was significantly higher in group A ( 13 of 15 patients , 86.7 % ) than in group B ( 5 of 12 patients , 41.7 % ) ( P < 0.05 ) .\
RESULTS	However , the sustained virological response rate in patients with hepatitis C virus levels more than 1 Meq/mL was not significantly different between group A ( 1 of 7 patients , 14.3 % ) and group B ( 1 of 8 patients , 12.5 % ) .\
CONCLUSIONS	Twice-a-day interferon-beta therapy is more effective than once-a-day interferon-beta for the treatment of chronic hepatitis C patients with hepatitis C virus-RNA levels less than 1 Meq/mL .\
\
###1419014\
OBJECTIVE	To determine whether , following aerosolization of lidocaine for topical airway anesthesia , intravenous ( IV ) lidocaine produces toxic lidocaine blood concentrations .\
METHODS	Randomized , double-blind study .\
METHODS	University-affiliated hospital .\
METHODS	Forty healthy patients scheduled for outpatient surgery .\
METHODS	The patients received in a randomized , double-blind manner aerosolized lidocaine or placebo followed 10 minutes later by IV lidocaine or placebo .\
RESULTS	After completion of lidocaine or placebo aerosolization and 2 minutes following IV administration of either lidocaine or the placebo , venous blood samples were obtained .\
RESULTS	Lidocaine concentration was measured using a homogenous enzyme assay .\
RESULTS	The group receiving both aerosolized and IV placebo and the group receiving aerosolized lidocaine and an IV placebo had undetectable ( less than 0.05 micrograms/ml ) serum lidocaine levels .\
RESULTS	The groups that received either an aerosolized placebo or aerosolized lidocaine and IV lidocaine had similar serum lidocaine concentrations [ 3.34 + / - 0.46 vs. 3.24 + / - 0.55 micrograms/ml ( mean + / - SEM ) ; p greater than 0.05 by Mann-Whitney U test ] .\
CONCLUSIONS	IV lidocaine can be safely administered following aerosolization of lidocaine in spontaneously breathing patients without producing toxic blood lidocaine concentrations .\
\
###9360031\
OBJECTIVE	We recently reported that acupuncture treatment of stroke patients in the subacute stage gave additive therapeutic benefit .\
OBJECTIVE	The purpose of the present study was to determine , approximately one year after discharge from the rehabilitation hospital , whether the group differences still remained .\
METHODS	The patients were randomized into two groups : one acupuncture group and one control group , considering gender and side of hemispheral localization of lesion .\
METHODS	With regard to the main parameters the groups were comparable at baseline .\
METHODS	Initially , 45 stroke patients admitted to Sunnaas Rehabilitation Hospital were included in the study : median 40 days post stroke .\
METHODS	Forty-one of the patients were available one year after the treatment period : 21 patients in the acupuncture group and 20 controls .\
METHODS	All subjects received an individually adapted , multidisciplinary rehabilitation programme .\
METHODS	The acupuncture group received additional treatment with classical acupuncture for 30 min three to four times weekly for six weeks .\
METHODS	The patients were evaluated at inclusion , after six weeks and approximately 12 months after discharge from the rehabilitation hospital .\
METHODS	The Motor Assessment Scale ( MAS ) for stroke patients , Sunnaas Index of Activity of Daily Living ( ADL ) and Nottingham Health Profile ( NHP ) were used .\
METHODS	In addition , the social situations of the patients were recorded at one year follow-up .\
RESULTS	The results show that the acupuncture group improved significantly more than the controls , both during the treatment period of six weeks , and even more during the following year , both according to MAS , ADL , NHP and the social situation .\
CONCLUSIONS	Although the mechanism of the effects is debatable , there seems to be a positive long-term effect of acupuncture given in the subacute stage post stroke .\
\
###12534408\
BACKGROUND	: Effective intra-oesophageal acid suppression is an important therapeutic goal in complicated and atypical gastro-oesophageal reflux disease .\
OBJECTIVE	: To compare the efficacy of lansoprazole and pantoprazole in normalizing oesophageal acid exposure .\
METHODS	: Fifty patients with complicated or atypical gastro-oesophageal reflux disease were randomly assigned to receive 30 mg lansoprazole ( n = 26 ) or 40 mg pantoprazole ( n = 24 ) once daily .\
METHODS	Three to four weeks after the start of treatment , patients underwent 24-h oesophageal pH monitoring whilst on therapy .\
METHODS	If the results were improved but still abnormal , the dosage was doubled and pH monitoring was repeated .\
METHODS	If oesophageal acid exposure was not improved , the patient was shifted to the alternative drug regimen .\
RESULTS	: Oesophageal acid exposure was normalized in all 26 patients treated with lansoprazole ( in 35 % of cases with a double daily dosage ) , whereas in six of the 24 ( 25 % ) patients treated with pantoprazole it was neither normalized nor lowered ( P = 0.008 ) .\
RESULTS	Accordingly , the mean percentage acid reflux time was significantly lower for the lansoprazole group ( 2.1 ) than for the pantoprazole group ( 5.8 ) ( P = 0.032 ) .\
CONCLUSIONS	: Effective intra-oesophageal acid suppression can be accomplished more reliably with lansoprazole than with pantoprazole in patients with complicated and atypical gastro-oesophageal reflux disease .\
\
###22309470\
OBJECTIVE	The primary purpose of this study was to test a relatively efficient strategy for enhancing the capacity of juvenile drug courts ( JDC ) to reduce youth substance use and criminal behavior by incorporating components of evidence-based treatments into their existing services .\
METHODS	Six JDCs were randomized to a condition in which therapists were trained to deliver contingency management in combination with family engagement strategies ( CM-FAM ) or to continue their usual services ( US ) .\
METHODS	Participants included 104 juvenile offenders ( average age = 15.4 years ; 83 % male ; 57 % White , 40 % African American , 3 % Biracial ) .\
METHODS	Eighty-six percent of the youths met criteria for at least 1 substance use disorder , and co-occurring psychiatric diagnoses were highly prevalent .\
METHODS	Biological and self-report measures of substance use and self-reported delinquency were assessed from baseline through 9 months postrecruitment .\
RESULTS	CM-FAM was significantly more effective than US at reducing marijuana use , based on urine drug screens , and at reducing both crimes against persons and property offenses .\
RESULTS	Such favorable outcomes , however , were not observed for the self-report measure of substance use .\
RESULTS	Although some variation in outcomes was observed between courts , the outcomes were not moderated by demographic characteristics or co-occurring psychiatric disorders .\
CONCLUSIONS	The findings suggest that JDC practices can be enhanced to improve outcomes for participating juvenile offenders .\
CONCLUSIONS	A vehicle for promoting such enhancements might pertain to the development and implementation of program certification standards that support the use of evidence-based interventions by JDCs .\
CONCLUSIONS	Such standards have been fundamental to the successful transport of evidence-based treatments of juvenile offenders .\
\
###23897954\
OBJECTIVE	To retrospectively evaluate the pattern of recurrence and outcome of node-negative breast cancer ( BC ) according to major subtypes .\
METHODS	In all , 1,951 patients with node-negative , early-stage BC randomly assigned in International Breast Cancer Study Group Trials VIII and IX with centrally reviewed pathology data were included .\
METHODS	BC subtypes were defined as triple negative ( TN ; n = 310 ) , human epidermal growth factor receptor 2 ( HER2 ) positive ( n = 369 ) , and hormone receptor positive with high ( luminal B-like [ LB-like ] ; n = 763 ) or low ( luminal A-like [ LA-like ] ; n = 509 ) proliferative activity by Ki-67 labeling index .\
METHODS	BC-free interval ( BCFI ) events were invasive BC recurrence in local , contralateral breast , nodal , bone , or visceral sites .\
METHODS	Time to first site-specific recurrence was evaluated by using cumulative incidence and competing risks regression analysis .\
RESULTS	Median follow-up was 12.5 years .\
RESULTS	The 10-year BCFI was higher for patients with LA-like ( 86 % ) BC compared with LB-like ( 76 % ) , HER2 ( 73 % ) , and TN ( 71 % ; P < .001 ) BC .\
RESULTS	TN and HER2 cohorts had higher hazard of BCFI event in the first 4 years after diagnosis ( pre-trastuzumab ) .\
RESULTS	LB-like cohorts had a continuously higher hazard of BCFI event over time compared with LA-like cohorts .\
RESULTS	Ten-year overall survival was higher for LA-like ( 89 % ) compared with LB-like ( 83 % ) , HER2 ( 77 % ) , and TN ( 75 % ; P < .001 ) BC .\
RESULTS	LB-like subtypes had higher rates of bone as first recurrence site than other subtypes ( P = .005 ) .\
RESULTS	Visceral recurrence as first site was lower for the LA-like subgroup , with similar incidence among the other subgroups when treated with chemotherapy ( P = .003 ) .\
CONCLUSIONS	BC subtypes have different distant recurrence patterns over time .\
CONCLUSIONS	Defining different patterns of BC recurrence can improve BC care through surveillance guidelines and can guide the design of clinical studies .\
\
###15040540\
OBJECTIVE	A high level of adherence to antiretroviral therapy is required for complete suppression of HIV replication , immunological and clinical effectiveness .\
OBJECTIVE	We investigated whether cognitive behaviour therapy can improve medication adherence .\
METHODS	Prospective randomized 1-year trial .\
METHODS	Collaboration of HIV university outpatient clinic and psychotherapists in private practice .\
METHODS	60 HIV-infected persons on stable antiretroviral combination therapy and viral load below 50 copies/ml .\
METHODS	Cognitive behaviour intervention in individual patients , in addition to standard of care .\
METHODS	Feasibility and acceptance of intervention ; adherence to therapy assessed using medication event monitoring system ( MEMS ) and self-report questionnaire ; virological failure ; psychosocial measures .\
RESULTS	The median number of sessions for cognitive behaviour intervention per patient during the 1-year trial was 11 ( range 2-25 ) .\
RESULTS	At months 10-12 , mean adherence to therapy as assessed using MEMS was 92.8 % in the intervention and 88.9 % in the control group ( P = 0.2 ) ; the proportion of patients with adherence > or = 95 % was 70 and 50.0 % ( P = 0.014 ) , respectively .\
RESULTS	While there was no significant deterioration of adherence during the study in the intervention arm , adherence decreased by 8.7 % per year ( P = 0.006 ) in the control arm .\
RESULTS	No differences between the intervention group and standard of care group were found regarding virological outcome .\
RESULTS	Compared with the control group , participants in the intervention group perceived a significant improvement of their mental health during the study period .\
CONCLUSIONS	Cognitive behavioural support in addition to standard of care of HIV-infected persons is feasible in routine practice , and can improve medication adherence and mental health .\
\
###15199624\
OBJECTIVE	To observe the clinical efficacy of TCM with supplementing Qi , nourishing Yin and clearing heat principle ( SQNYCH ) combined with chemotherapy in treating myelocytic leukemia .\
METHODS	One hundred and fourteen patients were randomly divided into the treated group ( n = 68 ) and the control group ( n = 46 ) .\
METHODS	To the treated group , SQNYCH was applied as the basic treatment , with combined chemotherapeutic protocol , using DA , HA and IA , to induce remission , and to the M3 patients , all-trans retinoic acid and arsenic trioxide were given .\
METHODS	As for patients in the control group , only western medicine was administered .\
RESULTS	In the treated group 49 patients ( 72.1 % ) were completely remitted , 9 ( 13.2 % ) partially remitted and the total remission rate being 85.3 % , which was significantly different from that in the control group .\
RESULTS	After treatment , the blood and bone marrow picture were obviously improved in both groups , but the increase of hemoglobin and platelet were better in the treated group than in the control group ( P < 0.05 or P < 0.01 ) .\
RESULTS	Immune functions were enhanced in both groups , but the elevation of CD4 , CD4/CD8 ratio and NK cells were higher in the treated group than in the control group ( P < 0.05 and P < 0.01 ) .\
CONCLUSIONS	Application of SQNYCH principle in treating acute myelocytic leukemia could elevate the clinical efficacy , which is of great value in clinical practice .\
\
###15741989\
OBJECTIVE	We designed this study to investigate the effects of oral L-carnitine administration on fasting plasma glucose ( FPG ) , glycosylated hemoglobin ( HbA1c ) and lipid parameters in patients with diabetes mellitus type II .\
METHODS	The effect of L-carnitine on FPG and lipid parameters was investigated in 22 male and 13 female type II diabetic patients ; the mean age + / - s.d. was 51.3 + / - 3.7 y.\
METHODS	The patients were randomly allocated to two groups ( L-carnitine and placebo group ) and 1 g of L-carnitine or of placebo was given orally three times a day for a period of 12 weeks .\
RESULTS	FPG in the L-carnitine group decreased significantly from 143 + / - 35 to 130 + / - 33 mg/dl ( P = 0.03 ) , and we observed a significant increase of triglycerides ( TG ) from 196 + / -61 to 233 + / -12 mg/dl ( P = 0.05 ) , of Apo A1 from 94 + / - 20 to 103 + / - 23 mg/dl ( P = 0.02 ) , and of Apo B100 from 98 + / - 18 to 108 + / - 22 mg/dl ( P = 0.02 ) after 12 weeks of treatment .\
RESULTS	There was no significant change in LDL-C , HDL-C , HbA1C , LP ( a ) or total cholesterol .\
CONCLUSIONS	L-Carnitine significantly lowers FPG but increases fasting triglyceride in type II diabetic patients .\
\
###18469257\
BACKGROUND	An understanding of the relations among dietary zinc intake , bioavailability , and absorption is necessary for making dietary intake recommendations .\
OBJECTIVE	We aimed to assess adaptation in human zinc absorption to controlled differences in zinc and phytate intakes and to apply the results to predictive models .\
METHODS	In 3 experiments , radiotracers were used to assess zinc absorption by healthy adults ( n = 109 ) from controlled diets , before and after 4 or 8 wk of dietary equilibration .\
METHODS	Subjects consumed 4-29 mg Zn/d from 1 of 10 diets , 5 with molar ratios of phytate to zinc from 2 to 7 and 5 with ratios from 15 to 23 .\
RESULTS	Absorptive efficiency was inversely related to dietary zinc from both low - and high-phytate diets .\
RESULTS	In response to low zinc intakes ( < 11 mg/d ) for 4-8 wk , zinc absorption was up-regulated to as high as 92 % , but only if the diets were low in phytate .\
RESULTS	The results help validate and refine a published saturable transport model that predicts zinc absorption from dietary zinc and phytate .\
RESULTS	Possible biomarkers of impaired zinc status , including erythrocyte osmotic fragility , in vitro erythrocyte ( 65 ) Zn uptake , and leukocyte expression of the zinc transport proteins Zip1 and ZnT1 , were unresponsive to dietary zinc content .\
CONCLUSIONS	Humans absorbed zinc more efficiently from low-zinc diets and adapted to further increase zinc absorption after consuming low-zinc , low-phytate diets for several weeks .\
CONCLUSIONS	Such adaptation did not occur with higher phytate diets .\
CONCLUSIONS	Zinc absorption can be predicted from dietary zinc and phytate after allowing for dietary equilibration .\
\
###24345834\
OBJECTIVE	The aim of the study was to determine whether docosahexaenoic acid ( DHA ) supplementation improves the behavior of children with autism .\
METHODS	A group of 3 - to 10-year-old children with autism were randomized in a double-blind fashion to receive a supplement containing 200 mg of DHA or a placebo for 6 months .\
METHODS	The parents and the investigator completed the Clinical Global Impressions-Improvement scale to rate changes in core symptoms of autism after 3 and 6 months .\
METHODS	The parents completed the Child Development Inventory and the Aberrant Behavior Checklist , and both parents and teachers completed the Behavior Assessment Scale for Children ( BASC ) at enrollment and after 6 months .\
RESULTS	A total of 48 children ( 40 [ 83 % ] boys , mean age [ standard deviation ] 6.1 [ 2.0 ] years ) were enrolled ; 24 received DHA and 24 placebo .\
RESULTS	Despite a median 431 % increase in total plasma DHA levels after 6 months , the DHA group was not rated as improved in core symptoms of autism compared to the placebo group on the CGI-I .\
RESULTS	Based on the analysis of covariance models adjusted for the baseline rating scores , parents ( but not teachers ) provided a higher average rating of social skills on the BASC for the children in the placebo group compared to the DHA group ( P = 0.04 ) , and teachers ( but not parents ) provided a higher average rating of functional communication on the BASC for the children in the DHA group compared to the placebo group ( P = 0.02 ) .\
CONCLUSIONS	Dietary DHA supplementation of 200 mg/day for 6 months does not improve the core symptoms of autism .\
CONCLUSIONS	Our results may have been limited by inadequate sample size .\
\
###25552412\
OBJECTIVE	To evaluate the role of calcium infusion as a preventive strategy of ovarian hyperstimulation syndrome ( OHSS ) in women at high risk in in vitro fertilization ( IVF ) / intracytoplasmic sperm injection ( ICSI ) treatment cycles .\
METHODS	Double-blinded randomized controlled trial .\
METHODS	University hospital department of obstetrics and gynecology and private IVF center .\
METHODS	Two hundred women at risk to develop OHSS undergoing IVF/ICSI treatment cycle .\
METHODS	The intervention group ( group 1 ; n = 100 ) received intravenous infusion of 10 mL 10 % calcium gluconate in 100 mL 0.9 % saline solution on the day of ovum pick-up ( OPU ) and days 1 , 2 , and 3 after , and the placebo group ( group 2 ; n = 100 ) received 100 mL 0.9 % saline solution on the day of OPU and days 1 , 2 , and 3 after .\
METHODS	Incidence of OHSS .\
RESULTS	OHSS incidence was significantly higher in the placebo group ( group 2 ) than in the calcium infusion group ( group 1 ) : 23 ( 23 % ) vs. 7 ( 7 % ) ; moderate OHSS was significantly higher in group 2 than in group 1 : 8 ( 8 % ) vs. 1 ( 1 % ) ; and severe OHSS was significantly higher in group 2 than in group 1 : 4 ( 4 % ) vs. 0 .\
CONCLUSIONS	Intravenous calcium infusion effectively reduced the incidence of OHSS development without reduction in the pregnancy rate .\
BACKGROUND	NCT01427335 .\
\
###17914062\
OBJECTIVE	To determine an effective and tolerable dose of a novel oral calcitonin gene-related peptide ( CGRP ) receptor antagonist , MK-0974 , for the acute treatment of migraine .\
METHODS	Randomized , double-blind , parallel-group , clinical trial with a two-stage , adaptive , dose-ranging design .\
METHODS	Patients were allocated to treat a moderate or severe migraine attack with MK-0974 ( 25 , 50 , 100 , 200 , 300 , 400 , or 600 mg ) , rizatriptan 10 mg , or placebo taken orally .\
METHODS	The primary endpoint was pain relief ( reduction to mild or none ) 2 hours after dosing .\
METHODS	Secondary endpoints included pain freedom at 2 hours and sustained pain relief at 24 hours .\
METHODS	A prespecified , blinded , automated interim analysis was used to discontinue randomization to less effective doses .\
RESULTS	Per the adaptive study design , the four lowest MK-0974 groups ( 25 , 50 , 100 , 200 mg ) were discontinued due to insufficient efficacy .\
RESULTS	For the remaining treatment groups , the estimated pain relief proportions at 2 hours were 300 mg ( n = 38 ) 68.1 % , 400 mg ( n = 45 ) 48.2 % , 600 mg ( n = 40 ) 67.5 % , rizatriptan 10 mg ( n = 34 ) 69.5 % , and placebo ( n = 115 ) 46.3 % .\
RESULTS	The prespecified primary efficacy hypothesis test , which compared the average 2-hour pain relief response proportion of the combined 300 , 400 , and 600 mg MK-0974 groups to placebo , was significant ( P = 0.015 ) .\
RESULTS	A generally similar efficacy pattern was seen for other endpoints .\
RESULTS	MK-0974 was generally well tolerated and there did not appear to be an increase in adverse events with increasing dose .\
CONCLUSIONS	The novel , orally administered calcitonin gene-related peptide ( CGRP ) receptor antagonist , MK-0974 , was effective and generally well tolerated for the acute treatment of migraine .\
\
###11056759\
BACKGROUND	Clinically useful predictions of end-organ function and failure in severe sepsis may be possible through analyzing the interactions among demographics , physiologic parameters , standard laboratory tests , and circulating markers of inflammation .\
BACKGROUND	The present study evaluated the ability of such a methodology , the Systemic Mediator Associated Response Test ( SMART ) , to predict the clinical course of septic surgery patients from a database of medical and surgical patients with severe sepsis and/or septic shock .\
METHODS	Three hundred and three patients entered into the placebo arm of a multi-institutional sepsis study were randomly assigned to a model-building cohort ( n = 200 ; 119 surgical ) or to a predictive cohort ( n = 103 ; 55 surgical ) .\
METHODS	Using baseline and baseline plus serial measurements of physiologic data , standard laboratory tests , and plasma levels of IL-6 , IL-8 , and granulocyte colony-stimulating factor ( GCSF ) , multivariate models were developed that predicted the presence or absence of pulmonary edema on chest radiography , and respiratory , renal , coagulation , hepatobiliary , or central nervous system dysfunction and shock in individual patients .\
METHODS	Twenty-eight-day survival was predicted also in baseline plus serial data models .\
METHODS	These models were validated prospectively by inserting baseline raw data from the 55 surgical patients in the predictive cohort into the models built on the comprehensive training cohort , and calculating the area under the curve ( AUC ) of predicted versus observed receiver operator characteristic ( ROC ) plots .\
RESULTS	SMART predictions of physiologic , respiratory , metabolic , hepatic , renal , and hematologic function indicators were validated prospectively , frequently at clinically useful levels of accuracy .\
RESULTS	ROC AUC values above 0.700 were achieved in 30 out of 49 ( 61 % ) of SMART baseline models in predicting shock and organ failure up to 7 days in advance , and in 30 out of 54 ( 56 % ) of baseline plus serial data models .\
CONCLUSIONS	SMART multivariate models accurately predict pathophysiology , shock , and organ failure in individual septic surgical patients .\
CONCLUSIONS	These prognostications may facilitate early treatment of end-organ dysfunction in surgical sepsis .\
\
###15058627\
BACKGROUND	The authors conducted a study to compare administration of local anesthetic using a computer-controlled delivery device with an aspirating syringe for therapeutic scaling and root planing .\
BACKGROUND	The anterior middle superior alveolar , or AMSA , injection was compared with other maxillary injections .\
METHODS	Twenty healthy adults with moderate periodontal disease participated in this single-blind crossover study .\
METHODS	Subjects were evaluated by a trained examiner and were treated by experienced dental hygienists .\
METHODS	Subjects provided written and verbal pain ratings via a visual analog scale , or VAS , and a verbal rating scale , or VRS .\
METHODS	AMSA injections were compared with syringe-delivered injections -- greater palatine , or GP , and nasopalatine , or NP , blocks , and anterior superior alveolar and middle superior alveolar injections -- in maxillary quadrants .\
METHODS	Bleeding and changes in attachment were evaluated after one month .\
RESULTS	VAS and VRS scores for AMSA were significantly lower for computer-controlled delivery when compared with NP injections and combined maxillary injections ( VAS scores ) and with GP and combined maxillary injections ( VRS scores ) .\
RESULTS	Mean injection times were similar for both groups .\
RESULTS	Mean gains in attachment were equal , 0.19 millimeters for quadrants anesthetized using computer-controlled injections and 0.22 mm for syringe injections .\
CONCLUSIONS	Subjects reported having less pain with GP and NP injections delivered using the computer-controlled device , and total injection time was similar to that required for syringe injections .\
CONCLUSIONS	Both techniques provided adequate anesthesia for therapeutic scaling and root planing .\
CONCLUSIONS	Clinical Implications .\
CONCLUSIONS	The two anesthetic delivery techniques were therapeutically equivalent for mandibular injections , and the AMSA injection has clinically significant advantages for maxillary injections .\
\
###12106522\
BACKGROUND	Erectile dysfunction is a common complication in patients with diabetes mellitus , which impairs quality of life , decreases self-esteem and can affect partners relationships .\
BACKGROUND	Sildenafil improves nitric oxide-dependent relaxation of smooth muscle in corpora cavernosa -- induced by an increase in cGMP via inhibition of phosphodiesterase 5 .\
METHODS	Multicenter , randomized , double-blind , placebo-controlled study with flexible doses of sildenafil .\
METHODS	The study was performed in 16 centers and recruited a total of 112 subjects with diabetes mellitus who had erectile dysfunction .\
METHODS	At the start and end of the study , the following questionnaires were administered : International Index of Erectile Function ( IIEF ) , Global Efficacy Assessment Question and Quality of Life Questionnaire ( Fugl-Meyer ) .\
METHODS	Of the 112 initially recruited patients , 92 received treatment , sildenafil in 44 and placebo in 48 .\
RESULTS	A clear improvement was observed in the capacity to achieve and maintain an erection ; 55.3 % diabetic patients receiving sildenafil had at least one successful sexual intercourse ( 15.6 % in the placebo group ) .\
RESULTS	In addition , significant improvements were seen in other aspects of the sexual activity of treated subjects .\
RESULTS	Among those treated with sildenafil , 46.3 % reported a clear improvement of erections as compared to their baseline conditions ( i.e , prior to treatment ) vs only 14.9 % in the placebo group .\
RESULTS	The percentage of a successful intercourse clearly increased , from 6 to 49 % .\
RESULTS	Sildenafil was well-tolerated .\
RESULTS	Side effects were mild and transient .\
CONCLUSIONS	Sildenafil is an effective , safe treatment for erectile dysfunction in diabetic patients .\
\
###16447664\
OBJECTIVE	To provide a new therapy with definite quality controllable therapeutic effects for functional restoration of the affected limbs in hemiplegic patients due to cerebral thrombosis .\
METHODS	180 patients with hemiplegia due to cerebral thrombosis were randomly divided into 2 groups : the treatment group ( treated with scalp acupuncture by using the lifting manipulation ) and the control group ( treated with scalp acupuncture by using the twirling manipulation ) .\
METHODS	Evaluations were given for the two groups based on the improvement of myodynamia and comprehensive functions after the treatment .\
RESULTS	Both groups showed increased myodynamia , but with different cured and much relieved rates ( 86.67 % in the treatment group and 5 % in the control group , P < 0.01 ) .\
CONCLUSIONS	Scalp acupuncture with the lifting manipulation can dramatically increase myodynamia of the affected limbs in hemiplegic patients due to cerebral thrombosis .\
\
###9085389\
BACKGROUND	This study was undertaken to examine the effects of acupuncture on smoking reduction and possibly also cessation and to examine whether some acupoints are more effective than others for smoking cessation .\
METHODS	A total of 46 healthy men and women , 39 + / - 9 years of age ( mean + / - SD ) , who smoked 20 + / - 6 cigarettes per day and had smoked for 23 + / - 8 years , and who wanted to quit smoking , volunteered to participate .\
METHODS	The subjects were randomly assigned to two groups .\
METHODS	One group was given acupuncture treatment at points previously used for anti-smoking ( test group , TG ) .\
METHODS	The other group was given acupuncture treatment at points assumed to have no effect for smoking cessation ( control group , CG ) .\
METHODS	Before each treatment and after the last treatment each subject answered questionnaires about his or her smoking habits and attitudes .\
METHODS	In addition the concentrations of serum cotinine , serum thiocyanate , serum peroxides , and plasma fibrinogen were measured before the first and after the last acupuncture treatment .\
RESULTS	The daily cigarette consumption fell during the treatment period in both groups , but the reduction was larger for TG than for CG ( P < 0.002 ) .\
RESULTS	Altogether 31 % of subjects in TG had quit smoking completely at the end of the treatment , compared with none in CG .\
RESULTS	For TG the concentrations of cotinine and thiocyanate were reduced significantly after the treatment period ( P < 0.001 ) , but no significant reductions were observed for CG .\
RESULTS	For both groups the taste of tobacco worsened during the treatment period , but the effect was more pronounced for TG than for CG ( P < 0.05 ) .\
RESULTS	The desire to smoke fell significantly in both groups after treatment , and the reduction was larger for TG than for CG ( P < 0.001 ) .\
RESULTS	No significant changes in serum peroxides and plasma fibrinogen concentrations were observed during the treatment period for either group .\
CONCLUSIONS	This study suggests that acupuncture may help motivated smokers to reduce their smoking or even quit smoking completely .\
CONCLUSIONS	Different acupoints appear to have different effects for smoking cessation and reduction .\
\
###16409198\
BACKGROUND	New IgE sensitizations to proteins in allergen extracts have been shown to occur during allergen-specific immunotherapy ( IT ) .\
METHODS	Twenty-four healthcare workers ( HCWs ) -- patients included in a latex IT study -- were analysed , 16 in active treatment and eight in placebo .\
METHODS	Sera were obtained at baseline and after 6 months of IT and analysed with immunoblotting and CAP System with eight single recombinant latex allergens ( rHev b 1 , 3 , 5 , 6.01 , 8 , 9 , 10 , 11 , and a mix of rHev b1 , 5 , 6.01 and 8 ) .\
RESULTS	After IT with latex , three patients in the active treatment group had new IgE sensitizations , one to Hev b 5 , one to Hev b 11 and another to Hev b 6.01 .\
RESULTS	No other significant variation in mean of specific IgE to latex or recombinant allergens were observed in patients who received placebo or active treatment .\
RESULTS	A significant ( P = 0.012 ) negative correlation ( -0.72 ) was observed between maximal tolerated dose and specific IgE to Hev b 6.01 at baseline .\
RESULTS	After IT , immunoblot analysis demonstrated a significant increase in IgE binding in a band of approximately 22 kDa ( P = 0.032 ) that may correspond to Hev b 6.01 .\
RESULTS	New or more intense bands appeared in seven patients of the active group , while in three subjects a reduction was observed .\
CONCLUSIONS	Hev b 6.01 seems to be the most relevant latex allergen in HCWs .\
CONCLUSIONS	New or more intense IgE binding to latex allergenic components occurs during latex immunotherapy .\
CONCLUSIONS	However , the levels of specific IgE against these new components are low and do not seem to have clinical relevance .\
\
###12206948\
OBJECTIVE	To determine whether body balance is perturbed more in low back pain patients than in healthy subjects , under the concept of posturo-kinetic capacity .\
METHODS	Comparison of posturographic and respiratory parameters between low back pain and healthy subjects .\
BACKGROUND	It has been demonstrated that respiratory movements constitute a perturbation to posture , compensated by movements of the spine and of the hips , and that low back pain is frequently associated with a loss of back mobility .\
METHODS	Ten low back pain patients and ten healthy subjects performed five posturographic tests under three different respiratory rate conditions : quiet breathing ( spontaneous ) , slow breathing ( 0.1 Hz ) and fast breathing ( 0.5 Hz ) .\
RESULTS	Intergroup comparison showed that the mean displacements of the center of pressure were greater for the low back pain group , especially along the antero-posterior axis , where respiratory perturbation is primarily exerted .\
RESULTS	Inter-condition comparison showed that in slow and fast breathing relatively to quiet breathing , the mean displacement of the center of pressure along the antero-posterior axis was significantly increased only for the low back pain group .\
CONCLUSIONS	According to the results , respiration presented a greater disturbing effect on body balance in low back pain subjects .\
CONCLUSIONS	This study provides information on the causes of the impaired body balance associated with chronic low back pain , which could be used to improve treatment strategy .\
\
###20825669\
BACKGROUND	Substance use is highly prevalent among Dutch adolescents .\
BACKGROUND	The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents .\
BACKGROUND	Although the program 's effectiveness was tested in a quasi-experimental design before , many program changes were made afterwards .\
BACKGROUND	The present study , therefore , aims to test the effects of this widely used , renewed universal prevention program .\
METHODS	A randomized clustered trial will be conducted among 3,784 adolescents of 23 secondary schools in The Netherlands .\
METHODS	The trial has three conditions ; two intervention conditions ( i.e. , e-learning and integral ) and a control condition .\
METHODS	The e-learning condition consists of three digital learning modules ( i.e. , about alcohol , tobacco , and marijuana ) that are sequentially offered over the course of three school years ( i.e. , grade 1 , grade 2 , and grade 3 ) .\
METHODS	The integral condition consists of parental participation in a parental meeting on substance use , regulation of substance use , and monitoring and counseling of students ' substance use at school , over and above the three digital modules .\
METHODS	The control condition is characterized as business as usual .\
METHODS	Participating schools were randomly assigned to either an intervention or control condition.Participants filled out a digital questionnaire at baseline and will fill out the same questionnaire three more times at follow-up measurements ( 8 , 20 , and 32 months after baseline ) .\
METHODS	Outcome variables included in the questionnaire are the percentage of binge drinking ( more than five drinks per occasion ) , the average weekly number of drinks , and the percentage of adolescents who ever drunk a glass of alcohol and the percentage of adolescents who ever smoked a cigarette or a joint respectively for tobacco and marijuana .\
CONCLUSIONS	This study protocol describes the design of a randomized clustered trial that evaluates the effectiveness of a school-based prevention program .\
CONCLUSIONS	We expect that significantly fewer adolescents will engage in early or excessive substance use behaviors in the intervention conditions compared to the control condition as a direct result of the intervention .\
CONCLUSIONS	We expect that the integral condition will yield most positive results , compared with the e-learning condition and control condition .\
BACKGROUND	The protocol for this study is registered with the Nederlands Trial Register NTR1516 .\
\
###14601351\
BACKGROUND	Common mental health problems account for up to 40 % of all general practitioner ( GP ) consultations .\
BACKGROUND	Patients have limited access to evidence-based psychological therapies .\
BACKGROUND	Cognitive behavioural therapy self-help strategies offer one potential solution .\
OBJECTIVE	To determine differences in clinical outcome , patient satisfaction and costs , between a cognitive behavioural-based self-help package facilitated by practice nurses compared to ordinary care by GPs for mild to moderate anxiety and depression .\
METHODS	Randomised controlled trial .\
METHODS	Seventeen primary healthcare teams .\
METHODS	Patients presenting to their GP with mild to moderate anxiety and/or depression were recruited to the study and randomised to receive either a self-help intervention facilitated by practice nurses or ordinary care .\
METHODS	The self-help intervention consisted of up to three appointments : two 1 week apart and a third 3 months later .\
METHODS	There were no restrictions on ordinary care .\
RESULTS	Intention-to-treat analysis showed that patients treated with practice nurse-supported cognitive behavioural therapy self-help attained similar clinical outcomes for similar costs and were more satisfied than patients treated by GPs with ordinary care .\
RESULTS	On-treatment analysis showed patients receiving the facilitated cognitive behavioural therapy self-help were more likely to be below clinical threshold at 1 month compared to the ordinary care group ( odds ratio [ OR ] = 3.65 , 95 % confidence interval [ CI ] = 1.87 to 4.37 ) .\
RESULTS	This difference was less well marked at 3 months ( OR = 1.36 , 95 % CI = 0.52 to 3.56 ) .\
CONCLUSIONS	Facilitated cognitive behavioural self-help may provide a short-term cost-effective clinical benefit for patients with mild to moderate anxiety and depression .\
CONCLUSIONS	This has the potential to help primary care provide a choice of effective psychological as well as pharmacological treatments for mental health problems .\
\
###17503670\
BACKGROUND	Succinylated human serum albumin ( Suc-HAS ) is a negatively charged neo-glycoprotein that binds to the positively charged V3-loop of HIV-1 gp120 , acting as HIV-1-fusion inhibitor in vitro ( IC50 : 0.5-5 .0 microg/ml ) .\
BACKGROUND	Suc-HSA was safe in rats and monkeys , and showed antiretroviral effect in a human-to-mouse model .\
BACKGROUND	We evaluated safety and pharmacokinetics of single and multiple doses of Suc-HSA in HIV-1-infected individuals .\
METHODS	First , six untreated , chronically HIV-1-infected patients were randomized to a single dose of 1 or 10 mg/kg Suc-HSA intravenously .\
METHODS	Second , five consecutive daily doses ( 10 mg/kg , based on the results of the single dose study ) were given to four patients .\
METHODS	Safety laboratory assessments , Suc-HSA plasma levels , plasma HIV-1 RNA ( pVL ) , and CD4 + T-cell counts were determined .\
RESULTS	Increase of liver transaminases ( grade 1/2 ) occurred in one of six patients in the single-dose phase and in three of four patients in the multiple-dosing phase .\
RESULTS	Suc-HSA plasma levels were undetectable 4 h after a single dose of 1 mg/kg .\
RESULTS	After a dose of 10 mg/kg , plasma levels were more sustained , but declined under the target plasma concentration ( 10 microg/ml ) 12-24 h post-dosing .\
RESULTS	After multiple dosing , plasma levels reached peak values 2h post-dosing as predicted by our kinetic model .\
RESULTS	However , trough levels were below the target concentrations .\
RESULTS	There was no change in pVL or CD4 + T-cell count in either the single - or multiple-dosing phase .\
CONCLUSIONS	At the chosen dosing regimens , adequate antiviral plasma levels were not maintained , probably because the hepatic clearance was more rapid than expected .\
CONCLUSIONS	This may partially explain the lack of effect on pVL and CD4 + T-cell count .\
CONCLUSIONS	The observed liver transaminase increases prohibit further dose escalation .\
\
###15951679\
BACKGROUND	We assessed response rates and compliance for a printed questionnaire and a Web questionnaire in a Swedish population-based study and explored the influence of adding personalized feedback to the Web questionnaire .\
METHODS	We assigned 875 subjects to 1 of 3 groups : printed questionnaire , plain Web questionnaire , or Web questionnaire with personalized feedback .\
METHODS	The questionnaire had 2 parts , first a general section and then a dietary section .\
RESULTS	The response rate for the general section was 64 % for the printed questionnaire , compared with 50 % for the Web questionnaire with feedback .\
RESULTS	For the dietary questionnaire , the rates were reversed , resulting in a total response rate for the dietary questionnaire that did not differ between printed and web questionnaire with feedback .\
CONCLUSIONS	Interactivity in the Web questionnaire increased compliance in completion of the second section of the questionnaire .\
CONCLUSIONS	Web questionnaires can be useful for research purposes in settings in which Internet access is high .\
\
###25370913\
BACKGROUND	Rye bread benefits glucose metabolism .\
BACKGROUND	It is unknown whether the same effect is achieved by rye bran-enriched wheat bread .\
BACKGROUND	We tested whether white wheat bread enriched with bioprocessed rye bran ( BRB+WW ) and sourdough wholegrain rye bread ( WGR ) have similar effects on glucose metabolism and plasma level of short chain fatty acids ( SCFAs ) .\
METHODS	Twenty-one ( 12 women ) of 23 recruited subjects completed an intervention with a four-week run-in and two four-week test periods in cross-over design .\
METHODS	White wheat bread ( WW ; 3 % fibre ) was consumed during the run-in , and WGR and BRB+WW ( 10 % fibre ) during the test periods .\
METHODS	A meal test providing 51/33/11 E % from carbohydrates/fat/protein was conducted at the end of each period .\
METHODS	Fasting and postprandial plasma samples were analysed for glucose , insulin , and SCFA .\
RESULTS	Glucose and insulin responses and plasma concentrations of SCFAs to the meal test were similar between the WGR and BRB+WW periods .\
RESULTS	When compared to the WW period , postprandial insulin concentration at 120 min was lower ( p = 0.023 ) and the first-phase insulin secretion improved ( p = 0.033 ) only after the WGR period , whereas postprandial concentrations of butyrate ( p < 0.05 ) and propionate ( p = 0.009 ) at 30 min increased during both rye bread periods .\
CONCLUSIONS	Beneficial effects of WGR over white wheat bread on glucose and SCFA production were confirmed .\
CONCLUSIONS	The enrichment of the white wheat bread with bioprocessed rye bran ( BRB+WW ) yielded similar but not as pronounced effects than WGR when compared to WW alone .\
CONCLUSIONS	Postprandially measured glucose metabolism and concentrations of SCFAs provided additional information along with fasting measurements .\
\
###8826808\
BACKGROUND	Allogeneic blood transfusion is associated with an increased frequency of postoperative infection .\
BACKGROUND	We studied whether such events can be avoided by the intraoperative and postoperative use of leucocyte-depleted blood .\
METHODS	589 consecutive patients scheduled for elective colorectal surgery were randomised to receive buffy-coat poor ( n = 299 ) or filtered leucocyte-depleted red-cells ( n = 290 ) when transfusion was indicated .\
METHODS	260 patients actually received blood transfusion .\
METHODS	Three patients were excluded from analysis .\
RESULTS	The 142 patients randomised to and transfused with buffy-coat-poor blood had a significantly higher frequency of wound infections and intra-abdominal abscesses than the 155 patients who were allocated to this group but who were not transfused .\
RESULTS	( 12 vs 1 % , p < 0.0001 ) and ( 5 vs 0 % , p = 0.005 ) , respectively .\
RESULTS	Those receiving buffy-coat-poor blood also had a significantly higher frequency of wound infections and intra-abdominal abscesses than the 118 randomised to and receiving leucocyte-depleted blood ( 12 vs 0 % , p < 0.0001 ) and ( 5 vs 0 % , p = 0.017 ) , respectively .\
RESULTS	Postoperative pneumonia occurred at a significantly higher rate in patients receiving buffy-coat-poor blood : 23 versus 3 % in non-transfused patients ( p < 0.0001 ) , and 23 versus 3 % in patients transfused with leucocyte-depleted blood ( p < 0.001 ) .\
RESULTS	The mortality rate between the groups was not statistically different .\
CONCLUSIONS	Our data suggests that the association between allogeneic blood transfusion and postoperative infection is limited to allogeneic blood products that are not adequately depleted of immunosuppressive leucocytes .\
CONCLUSIONS	This undesirable effect can be reduced by leucocyte depletion with high-efficiency filters .\
\
###10674563\
BACKGROUND	The value of cord blood IgE in predicting the development of asthma and other IgE-mediated allergic diseases is unclear .\
OBJECTIVE	The purpose of this study is twofold : ( 1 ) to determine factors affecting cord blood IgE level and ( 2 ) to determine whether cord blood IgE predicts the development of asthma and other IgE-mediated allergic diseases in high risk ( defined as those with at least one first degree relative with asthma or 2 first degree relatives with other IgE-mediated allergic diseases ) infants at 12 months .\
METHODS	The study utilized cord blood obtained from a group of high risk infants who took part in a randomized controlled trial to assess the effectiveness of an intervention program in the primary prevention of asthma and other IgE-mediated allergic diseases .\
METHODS	Total IgE and cotinine in the cord blood were measured .\
METHODS	Assessment of the infants was done at 12 months for these diseases .\
RESULTS	Sixty-four ( 17.8 % ) infants had detectable total IgE in cord blood > 0.5 kU/L .\
RESULTS	The proportion of infants with elevated cord blood IgE was significantly higher among nonwhites , birth during winter months , and those with a maternal history of asthma .\
RESULTS	There was no correlation between cord blood IgE and cord blood cotinine level .\
RESULTS	Cord blood IgE was found to be a significant predictor for the development of urticaria due to food allergy but not for other outcomes .\
CONCLUSIONS	Both genetic and environmental risk factors play a role in determining the level of IgE in cord blood .\
CONCLUSIONS	Cord blood IgE was a significant risk factor for the development of urticaria due to food allergy at 12 months of life .\
CONCLUSIONS	As urticaria due to food allergy is a prodrome for anaphylaxis , measurement of IgE in cord blood may be indicated in infants at high risk for developing allergic diseases so that preventive measures can be applied .\
\
###21564160\
BACKGROUND	Terutroban is a selective TP receptor antagonist , i.e. a specific antagonist of the thromboxane A ( 2 ) and prostaglandin endoperoxide receptors , shown to improve endothelial function after a single administration in patients with coronary artery disease .\
CONCLUSIONS	This randomized , double-blind , placebo-controlled trial demonstrates that repeated-dose terutroban for 15 days improves endothelial function and inhibits thromboxane A ( 2 ) - induced platelet aggregation in high-cardiovascular-risk patients taking 300 mg of aspirin per day .\
CONCLUSIONS	Terutroban may prove useful for preventing cardiovascular events in such patients .\
OBJECTIVE	The specific TP receptor antagonist terutroban improves endothelial function after a single dose in patients with coronary artery disease .\
OBJECTIVE	Our aim was to evaluate the effects and dose dependency of repeated-dose terutroban on endothelial function and platelet aggregation in high-cardiovascular-risk patients with carotid atherosclerosis .\
METHODS	We randomly allocated 48 patients taking 300 mg aspirin per day to placebo or to one of three terutroban dosages ( 2.5 , 5 or 10 mg ) for 15 days in a double-blind study .\
METHODS	Flow-mediated vasodilatation was evaluated before and 2 h after the first oral dose on day 0 and 2 h after the last oral dose on day 14 .\
RESULTS	On day 0 and day 14 , all three terutroban dosages improved flow-mediated vasodilatation and abolished platelet aggregation induced by the TP receptor agonist U46619 , without changing the aggregation response to ADP or collagen .\
CONCLUSIONS	Terutroban , by chronically improving endothelium-dependent vasodilatation and inhibiting platelet aggregation , may prove useful for preventing cardiovascular events in high-risk patients .\
\
###20739431\
OBJECTIVE	We did a randomized phase I/II trial designed to evaluate the safety and efficacy of combining the proteasome inhibitor bortezomib with high-dose melphalan as the conditioning for high-dose therapy and autologous transplant for myeloma .\
METHODS	Enrolled patients were limited to those who did not achieve a very good partial remission ( VGPR ) following one or more induction regimens , and were randomized to receive a single escalating dose of bortezomib ( 1.0 , 1.3 , or 1.6 mg/m ( 2 ) ) either 24 hours before or 24 hours after high-dose melphalan .\
METHODS	Dose escalation was based on the escalation with overdose control ( EWOC ) , a Bayesian statistical model .\
METHODS	Bone marrow aspirates were collected before initiation of therapy and at the time of transplant to evaluate which sequence resulted in maximal plasma cell apoptosis , and response to transplant was assessed by the International Myeloma Working Group criteria .\
RESULTS	Among 39 randomized patients , 20 received bortezomib after melphalan and 19 received bortezomib before melphalan .\
RESULTS	Toxicities and posttransplant hematopoietic recovery rates were similar between arms .\
RESULTS	The overall response rate for all patients was 87 % , with 51 % achieving a VGPR or better .\
RESULTS	Pharmacodynamic studies showed greater plasma cell apoptosis among patients who received bortezomib following melphalan .\
CONCLUSIONS	The use of bortezomib in conjunction with high-dose melphalan is safe , with data suggesting improved efficacy .\
CONCLUSIONS	A single dose of bortezomib administered after high-dose melphalan is the recommended dose and schedule for future clinical investigation .\
\
###19606048\
OBJECTIVE	Opioids are routinely administered to obtain a better control of postoperative pain .\
OBJECTIVE	The aim of the present study was to assess the intravenous morphine effect after caesarean delivery on the postoperative morphine requirements and pain .\
METHODS	Sixty-two parturients undergoing elective caesarean section under subarachnoid anaesthesia were randomly assigned in a double-blinded manner to the morphine or to the control group , to receive intraoperatively 0.15 mg kg morphine in 100 ml of isotonic saline or equal volume of normal saline .\
METHODS	Postoperative analgesia was ensured with patient-controlled analgesia morphine .\
METHODS	Postoperative pain at rest and after cough was assessed using the visual analogue scale ( VAS ) 2 , 4 , 8 , and 24 h. Morphine consumption was recorded at the same time points .\
RESULTS	Cumulative morphine consumption 2 , 4 , 8 , and 24 h postoperatively was 6 + / - 4.8 , 14 + / - 6.6 , 22 + / - 9.6 , and 42 + / - 15.7 mg in the morphine and 8 + / - 5.1 , 18 + / - 7.7 , 28 + / - 9.4 , and 43 + / - 17.4 mg in the control group ( F = 2.70 , DF = 1 , and P = 0.105 for intergroup comparisons ) .\
RESULTS	The VAS scores at rest did not differ between the two groups , being 28 + / - 22.3 , 40 + / - 21.4 , 28 + / - 18.5 , and 28 + / - 22.2 mm in the morphine group and 28 + / - 21.5 , 43 + / - 23.5 , 29 + / - 24.2 , and 19 + / - 24.8 mm in the controls ( F = 0.37 , DF = 1 , P = 0.848 ) .\
RESULTS	Similar results apply to the VAS scores recorded after cough .\
RESULTS	VAS values were 35 + / - 20.6 , 51 + / - 22.5 , 42 + / - 18.2 , and 46 + / - 23.6 mm in the morphine and 40 + / - 22.1 , 54 + / - 28.9 , 47 + / - 26.5 , and 38 + / - 26.9 mm in the control group , respectively .\
CONCLUSIONS	Morphine given after caesarean delivery under subarachnoid anaesthesia has no effect on analgesic requirements or acute postoperative pain .\
\
###22840353\
BACKGROUND	The advantages of robot-assisted radical prostatectomy ( RARP ) over laparoscopic radical prostatectomy ( LRP ) have rarely been investigated in randomised controlled trials .\
OBJECTIVE	To compare RARP and LRP in terms of the functional , perioperative , and oncologic outcomes .\
OBJECTIVE	The main end point of the study was changes in continence 3 mo after surgery .\
METHODS	From January 2010 to January 2011 , 120 patients with organ-confined prostate cancer were enrolled and randomly assigned ( using a randomisation plan ) to one of two groups based on surgical approach : the RARP group and the LRP group .\
METHODS	All RARP and LRP interventions were performed with the same technique by the same single surgeon .\
METHODS	The demographic , perioperative , and pathologic results , such as the complications and prostate-specific antigen ( PSA ) measurements , were recorded and compared .\
METHODS	Continence was evaluated at the time of catheter removal and 48 h later , and continence and potency were evaluated after 1 , 3 , 6 , and 12 mo. .\
METHODS	The student t test , Mann-Whitney test , ( 2 ) test , Pearson ( 2 ) test , and multiple regression analysis were used for statistics .\
CONCLUSIONS	The two groups ( RARP : n = 60 ; LRP : n = 60 ) were comparable in terms of demographic data .\
CONCLUSIONS	No differences were recorded in terms of perioperative and pathologic results , complication rate , or PSA measurements .\
CONCLUSIONS	The continence rate was higher in the RARP group at every time point : Continence after 3 mo was 80 % in the RARP group and 61.6 % in the LRP group ( p = 0.044 ) , and after 1 yr , the continence rate was 95.0 % and 83.3 % , respectively ( p = 0.042 ) .\
CONCLUSIONS	Among preoperative potent patients treated with nerve-sparing techniques , the rate of erection recovery was 80.0 % and 54.2 % , respectively ( p = 0.020 ) .\
CONCLUSIONS	The limitations included the small number of patients .\
CONCLUSIONS	RARP provided better functional results in terms of the recovery of continence and potency .\
CONCLUSIONS	Further studies are needed to confirm our results .\
\
###23759041\
OBJECTIVE	The study aims to determine if a vaginal examination improves diagnostic accuracy when assessing women who present to the ED with vaginal bleeding in the first trimester of pregnancy .\
METHODS	One hundred and thirty-five women with first trimester bleeding were randomised to have a vaginal examination ( n = 61 ) or not ( n = 74 ) .\
METHODS	They were given a provisional diagnosis , and then a final diagnosis after ultrasound , beta-human chorionic gonadotropin and gynaecological follow up .\
METHODS	The provisional diagnosis was considered accurate if it matched the final diagnosis .\
RESULTS	The provisional and final diagnoses matched in a little over half of the cases , and there was no statistical difference between the two groups ( ( 2 ) = 0.005 , P = 0.94 ) .\
CONCLUSIONS	In a stable patient presenting to the ED with first trimester bleeding , clinical diagnosis is highly inaccurate and is not improved by vaginal examination .\
CONCLUSIONS	Routine vaginal examination is not necessary as part of the initial patient assessment .\
\
###16024973\
OBJECTIVE	We investigated the association of a polymorphism within the promoter of TauNuF-alpha locus at the position -308 on the likelihood of having acute coronary syndromes ( ACS ) in Greek adults .\
METHODS	We studied demographic , lifestyle , and clinical information in 237 hospitalized patients ( 185 males ) with a first event of an ACS and 237 matched by age and sex ( controls ) without any clinical evidence of coronary heart disease .\
METHODS	Genotyping was performed by PCR-RFLP analysis .\
RESULTS	The genotype frequencies were in patients , 87 % ( n = 206 ) , 12 % ( n = 29 ) , and 1 % ( n = 2 ) for G/G , G/A , and A/A , and in controls , 96 % ( n = 227 ) , 4 % ( n = 10 ) , and 0 % ( n = 0 ) for G/G , G/A , and A/A , respectively ( P = 0.04 ) .\
RESULTS	After adjusting for age and sex , as well as various potential confounders , we observed that G/A or A/A genotypes were associated with 1.94-fold higher odds ( 95 % CI 1.06 to 3.68 ) of ACS compared to G/G homozygotes .\
RESULTS	No gene to-gender or to-clinical syndrome interactions were observed .\
RESULTS	Further subgroup analysis showed that the distribution of TNF-alpha -308 G > A polymorphism was associated with the presence of family history of CHD in patients , but not in controls .\
RESULTS	In particular , in G/A and A/A patients 17.2 % reported family history of CHD , whereas in G/G patients , 34.5 % reported family history ( P = 0.036 ) .\
CONCLUSIONS	Our findings may state a hypothesis of an association between the -308 G > A TNF-alpha polymorphism the development of ACS and the presence of family history of CHD , in Greece .\
\
###11432478\
BACKGROUND	Cerebral injury after Cardiopulmonary bypass ( CPB ) is still a serious and unpredictable complication .\
BACKGROUND	The S-100beta serum marker has been suggested as potentially useful in the detection of cerebral injury during and after CPB .\
BACKGROUND	Direct comparisons of whether laminar or pulsatile pump flow in CABG leads to higher S-100beta values and which type might be more neuroprotective have not been made so far .\
METHODS	All 21 patients of the study were undergoing CABG for the first time and had no history of cerebral disease in whatever form .\
METHODS	They were divided into two groups : laminar ( n = 10 ) versus pulsatile ( n = 11 ) pump flow .\
METHODS	In all cases , a Stckert roller pump ( Fa .\
METHODS	Stckert , Munich , Germany ) with a laminar and pulsatile running mode was used for cardiopulmonary bypass .\
METHODS	Serum S-100beta levels were detected using a monoclonal immunoradiometric assay ( Sangtec Medical AB , Bromma , Sweden ) .\
METHODS	In total , 5 different samples were drawn per patient , starting before intubation and ending 36 hours after surgery .\
RESULTS	S-100beta peak values were found at skin closure .\
RESULTS	Median levels were lower in the pulsatile group .\
RESULTS	Due to the small study group and wide range , results are non-significant .\
CONCLUSIONS	The results indicate that pulsatile flow might have a more neuroprotective effect than laminar flow as S-100beta values were lower .\
\
###23483175\
OBJECTIVE	Evidence that longer-term and exclusive breastfeeding reduces child obesity risk is based on observational studies that are prone to confounding .\
OBJECTIVE	To investigate effects of an intervention to promote increased duration and exclusivity of breastfeeding on child adiposity and circulating insulin-like growth factor ( IGF ) - I , which regulates growth .\
METHODS	Cluster-randomized controlled trial in 31 Belarusian maternity hospitals and their affiliated clinics , randomized into 1 of 2 groups : breastfeeding promotion intervention ( n = 16 ) or usual practices ( n = 15 ) .\
METHODS	Participants were 17,046 breastfeeding mother-infant pairs enrolled in 1996 and 1997 , of whom 13,879 ( 81.4 % ) were followed up between January 2008 and December 2010 at a median age of 11.5 years .\
METHODS	Breastfeeding promotion intervention modeled on the WHO/UNICEF Baby-Friendly Hospital Initiative ( World Health Organization/United Nations Children 's Fund ) .\
METHODS	Body mass index ( BMI ) , fat and fat-free mass indices ( FMI and FFMI ) , percent body fat , waist circumference , triceps and subscapular skinfold thicknesses , overweight and obesity , and whole-blood IGF-I .\
METHODS	Primary analysis was based on modified intention-to-treat ( without imputation ) , accounting for clustering within hospitals and clinics .\
RESULTS	The experimental intervention substantially increased breastfeeding duration and exclusivity when compared with the control ( 43 % vs 6 % exclusively breastfed at 3 months and 7.9 % vs 0.6 % at 6 months ) .\
RESULTS	Cluster-adjusted mean differences in outcomes at 11.5 years of age between experimental vs control groups were : 0.19 ( 95 % CI , -0.09 to 0.46 ) for BMI ; 0.12 ( -0.03 to 0.28 ) for FMI ; 0.04 ( -0.11 to 0.18 ) for FFMI ; 0.47 % ( -0.11 % to 1.05 % ) for percent body fat ; 0.30 cm ( -1.41 to 2.01 ) for waist circumference ; -0.07 mm ( -1.71 to 1.57 ) for triceps and -0.02 mm ( -0.79 to 0.75 ) for subscapular skinfold thicknesses ; and -0.02 standard deviations ( -0.12 to 0.08 ) for IGF-I .\
RESULTS	The cluster-adjusted odds ratio for overweight/obesity ( BMI 85th vs < 85th percentile ) was 1.18 ( 95 % CI , 1.01 to 1.39 ) and for obesity ( BMI 95th vs < 85th percentile ) was 1.17 ( 95 % CI , 0.97 to 1.41 ) .\
CONCLUSIONS	AND RELEVANCE Among healthy term infants in Belarus , an intervention that succeeded in improving the duration and exclusivity of breastfeeding did not prevent overweight or obesity , nor did it affect IGF-I levels at age 11.5 years .\
CONCLUSIONS	Breastfeeding has many advantages but population strategies to increase the duration and exclusivity of breastfeeding are unlikely to curb the obesity epidemic .\
BACKGROUND	isrctn.org : ISRCTN37687716 ; and clinicaltrials.gov : NCT01561612 .\
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###14750352\
BACKGROUND	Nasal packing after routine nasal surgery is commonly practiced in the UK .\
BACKGROUND	The most popular pack appears to be Merocel , however this can be associated with significant pain on its removal .\
OBJECTIVE	To test the efficacy of a relatively new nasal pack -- the Rapid Rhino Goodman pack -- introduced to our department , which claims to reduce pain and bleeding after nasal surgery .\
METHODS	Fourteen patients undergoing routine nasal surgery were recruited into a randomised controlled trial .\
METHODS	One nasal cavity was packed with a Merocel pack and the other with a Rapid Rhino Goodman pack .\
METHODS	Patients were asked to record pain levels on each side using a visual analogue scale .\
RESULTS	We found no difference between packs whilst in-situ , with all patients recording low to moderate pain scores .\
RESULTS	There were significantly higher pain levels associated with Merocel pack removal than with Rapid Rhino pack removal ( average pain scores 5.64 vs 1.64 , p < 0.001 ) and less bleeding overall .\
CONCLUSIONS	Rapid Rhino ( Goodman pack ) is associated with significantly less pain on removal than Merocel pack , causes less bleeding and is not more painful whilst in-situ .\
CONCLUSIONS	We therefore recommend its use in routine nasal surgery .\
\
###17397003\
BACKGROUND	Resiquimod , an investigational immune response modifier and Toll-like receptor ( TLR ) 7 and 8 agonist , stimulates production of cytokines that promote an antigen-specific T helper type 1 ( Th1 ) -- acquired immune response .\
BACKGROUND	In animal models , induction of Th1-specific responses modifies experimental herpes simplex virus ( HSV ) infection .\
METHODS	We conducted a randomized , double-blind , vehicle-controlled trial to assess the efficacy of resiquimod 0.01 % gel for reducing human anogenital HSV-2 mucosal reactivation .\
METHODS	Adults with genital HSV-2 applied resiquimod or vehicle topically to herpes lesions 2 times weekly for 3 weeks and then collected daily anogenital swabs for 60 days for HSV DNA polymerase chain reaction .\
METHODS	Recurrences during the subsequent 7 months were treated with study gel .\
METHODS	During the final treatment-free 60 days , participants again collected daily swabs to assess shedding .\
RESULTS	The median lesion and shedding rates were lower for resiquimod compared with vehicle recipients during the initial sampling period ( 10 % vs. 16 % [ P = .03 ] and 10 % vs. 17 % [ P = .08 ] , respectively ) and during the final sampling period ( 3 % vs. 22 % [ P < .001 ] and 10 % vs. 26 % [ P = .009 ] , respectively ) .\
RESULTS	Resiquimod did not influence recurrence length .\
CONCLUSIONS	These findings suggest that the immunological control of HSV-2 reactivation and lesion clearance may differ and that TLR7 and TLR8 agonists can reduce the frequency of mucosal HSV-2 reactivation .\
\
###18476954\
BACKGROUND	Therapies targeting the T cell-mediated pathology of psoriasis have been found to achieve remarkable clinical improvement and have confirmed the crucial role of the immune system either in peripheral blood ( PB ) or in skin .\
BACKGROUND	No analyses of T-cell counts in both compartments have been conducted in order to confirm or refute the hypothesized shifts between them .\
OBJECTIVE	To gain more insight in the dynamics of compartmentalization of T cells between PB and lesional skin of patients with psoriasis , in response to immune-targeted antipsoriatic therapies .\
METHODS	Eighteen patients with psoriasis received either efalizumab ( n = 9 ) or etanercept ( n = 9 ) for 12 weeks .\
METHODS	Biopsies were taken for immunohistochemical analysis of T-cell subsets and simultaneously T-cell subsets were isolated from PB specimens by flow cytometry .\
RESULTS	The Psoriasis Area and Severity Index declined significantly after 12 weeks of etanercept , but not for efalizumab .\
RESULTS	After treatment with efalizumab , a significantly decreased number of all T-cell subsets was found in the dermis .\
RESULTS	In the epidermis , CD4 + , CD8 + , CD25 + , CD45RO + and CD161 + T-cell subsets were significantly decreased .\
RESULTS	With respect to etanercept , few significant changes in T-cell subsets were found .\
RESULTS	The percentage of lymphocytes in PB was significantly elevated after efalizumab treatment regardless of responder status .\
CONCLUSIONS	Treatment with efalizumab establishes successful recompartmentalization of T-cell subsets with modest clinical efficacy after 12 weeks , whereas in etanercept-treated patients , a significant clinical response is no guarantee for significant changes in T-cell subsets in the different compartments .\
CONCLUSIONS	Reductions in T-cell subsets can not be used as predictive markers for the clinical response to therapy .\
CONCLUSIONS	Interference with the studied T-cell populations in its own right seems not to be responsible for the clinical efficacy of efalizumab and etanercept .\
\
###22569489\
BACKGROUND	In the literature , it is not yet clear whether sex may affect the outcomes of exercise training in obese adults .\
OBJECTIVE	The aim of this study was to investigate gender difference in the effects of combined aerobic resistance exercise ( ARE ) versus aerobic exercise ( AE ) alone on body composition in overweight and obese adults .\
METHODS	Randomized clinical trial .\
METHODS	University-based outpatient clinic .\
METHODS	Sixty-five healthy , untrained overweight and obese men and women\
METHODS	They were randomized into one of two intervention groups ; AE group ( N. = 33 ) performed leg cycle exercises with increasing duration and frequency ; ARE group ( N. = 32 ) performed additionally progressive weight-resistance exercises for the upper and lower parts of body .\
METHODS	Both groups were asked not to change their diet .\
METHODS	Body composition including percentage of fat ( PF ) , fat mass ( FM ) and fat free mass ( FFM ) in regional and whole body was determined by dual-energy X-ray absorptiometry ( DXA ) at baseline and week 12 .\
RESULTS	ARE leads to more gains on regional and whole body FFM than AE .\
RESULTS	ARE was more effective in increasing the FFM of arms , trunk and whole body and decreasing PF of trunk in men and superior on reducing FM of legs in women when comparing with AE .\
CONCLUSIONS	In order to reduce the trunk fat in men and leg fat in women , resistance exercise can be added into an aerobic training program .\
CONCLUSIONS	Dissimilar results of exercises on sex obtained in our study serves as a guide for prescribing exercises in overweight and obese men and women .\
\
###12164745\
OBJECTIVE	To determine if UV-B phototherapy clears psoriasis through systemic effects .\
METHODS	Randomized , within-subject comparison of change in psoriasis in 3 plaques in patients attending for whole-body UV-B therapy .\
METHODS	Change in patients ' psoriasis plaques covered during UV-B treatment was compared with plaques in an untreated control group .\
METHODS	University hospital phototherapy unit .\
METHODS	The study population comprised 17 patients with chronic plaque psoriasis treated with UV-B and 24 psoriasis control patients awaiting UV-B phototherapy .\
METHODS	Treatment with a standard 3-times weekly narrowband TL-01 UV-B regimen .\
METHODS	Three similar plaques were randomly allocated to be covered every treatment , covered for 2 of 3 weekly treatments , and exposed to local UV-B every treatment .\
METHODS	Similar plaques were selected in control patients ( awaiting but not yet started UV-B therapy ) .\
METHODS	Severity of psoriasis plaques was assessed using a scaling , erythema , and induration ( SEI ) scoring system .\
METHODS	Change in SEI score of the selected plaques over the complete treatment course for UV-B-treated patients and change over 3 weeks in SEI score of plaques covered during UV-B treatment compared with that of plaques in controls .\
RESULTS	There was a significant ( P < .001 ) difference in how much the SEI score changed in the 3 plaques in UV-B-treated patients .\
RESULTS	It fell by a mean of 7.6 for uncovered plaques compared with 3.2 for plaques covered during each UV-B exposure ( 95 % confidence interval for difference , 3.0 to 5.8 ) .\
RESULTS	In patients awaiting UV-B , SEI score of plaques fell by a mean of 0.4 over 3 weeks , compared with a mean fall of 1.4 for covered plaques in UV-B-treated patients ( 95 % confidence interval for difference in means , 0.1 to 2.0 ) .\
CONCLUSIONS	If UV-B therapy has any systemic effect capable of improving psoriasis , this effect is small and unlikely to be of clinical importance .\
CONCLUSIONS	It is insufficient to alter interpretation of findings of within-subject comparative phototherapy studies .\
CONCLUSIONS	UV-B phototherapy works for chronic plaque psoriasis through local effects .\
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###23089349\
OBJECTIVE	The purpose of this prospective randomized trial was to examine the effect of tourniquet use on rehabilitation rate , return to work and sport activities , and muscle damage after arthroscopic meniscectomy .\
METHODS	Eighty patients who underwent arthroscopic partial meniscectomy were randomly allocated to the use of an inflated ( group A , n = 40 ) or deflated ( group B , n = 40 ) pneumatic tourniquet .\
METHODS	Patients with concomitant ligamentous deficiency or grade III and IV chondral lesions were excluded .\
METHODS	The primary outcome measures were pain , measured with a visual analog scale ( VAS ) , and knee range of motion ( ROM ) on days 8 and 15 postoperatively ; time required for patients to discontinue the use of crutches ; time to return to light activities and moderate sporting activities such as jogging ; and serum creatine phosphokinase ( CPK ) levels monitored preoperatively and on days 1 , 8 , and 15 postoperatively .\
RESULTS	The 2 groups did not differ in terms of age ; male-female ratio ; body mass index ; and preoperative International Knee Documentation Committee , Tegner , and Lysholm scores .\
RESULTS	Operative time was not significantly different between groups ( mean , 27.5 for group A and 31.2 for group B ; P = .83 ) .\
RESULTS	VAS pain scores and knee ROM were not significant between groups ( minimum P = .22 ) .\
RESULTS	The patients progressed to weight-bearing without crutches within 13.4 and 12.9 days for groups A and B , respectively ( P = .9 ) .\
RESULTS	Return to work and jogging did not differ significantly between groups ( minimum P = .34 ) .\
RESULTS	Serum CPK values were also not significantly different between or within groups during consecutive measurements ( P = .3 ) .\
RESULTS	Tourniquet time did not significantly affect postoperative ROM , VAS pain scores , or serum CPK levels ( minimum P = .14 ) .\
CONCLUSIONS	Tourniquet use for less than 30 minutes during arthroscopic meniscectomy does not affect postoperative pain or return to light work and jogging .\
CONCLUSIONS	In addition , tourniquet-induced muscle damage after arthroscopic meniscectomy , though potentially present locally , is not detectable in the systemic circulation .\
METHODS	Level I , prospective randomized trial .\
\
###7962654\
OBJECTIVE	To compare the degree of interstitial fibrosis in renal transplant biopsy specimens from immunosuppressed patients using conventional doses of cyclosporin with and without calcium channel blockade with a combination of low dose cyclosporin and azathioprine ; to correlate the degree of interstitial fibrosis with the glomerular filtration rate .\
METHODS	A single blind histomorphometric assessment was done of cortical interstitial volume fraction from biopsy specimens taken intraoperatively and at one , six , and 12 months after transplantation from three prospectively randomised groups of patients : ( A ) conventional dose cyclosporin ; ( B ) conventional dose cyclosporin plus nifedipine ; ( C ) low dose cyclosporin plus azathioprine .\
RESULTS	Interstitial volume increased with time in all groups .\
RESULTS	No differences in interstitial volume were present at operation or at one month , but at six months interstitial volume was significantly less in group B than group A ( p < 0.001 ) or group C ( p < 0.05 ) .\
RESULTS	More grafts failed in group A than group B leaving only small numbers for comparison at 12 months .\
RESULTS	At 12 months the differences persisted but did not reach significance .\
RESULTS	These results strongly reflected the clinical findings , where glomerular filtration rate was significantly lower in group A than groups B or C at six and 12 months ; no differences in glomerular filtration rate were found at one month .\
RESULTS	In a direct comparison glomerular filtration rate showed a significant negative correlation with interstitial volume fraction .\
CONCLUSIONS	These findings suggest that calcium channel blockade with nifedipine slows the development of interstitial fibrosis in renal transplant recipients treated with cyclosporin .\
CONCLUSIONS	When clinical data are considered , it is suggested that calcium channel blockade may have a mitigating effect on the long term nephrotoxic effects of cyclosporin and should be considered as adjunctive treatment in patients requiring this immunosuppressant following renal transplantation .\
\
###16541481\
OBJECTIVE	To evaluate safety and efficacy of longterm etanercept treatment in patients with disease modifying antirheumatic drug ( DMARD ) refractory rheumatoid arthritis ( RA ) .\
METHODS	Safety results are reported for 714 patients who received etanercept in one of 7 initial trials or a longterm extension .\
METHODS	Efficacy results are reported for 581 patients who enrolled in the extension .\
RESULTS	Of the 714 patients enrolled in the initial trials , 581 ( 81 % ) enrolled in the extension , and 388 ( 54 % ) patients are continuing to receive etanercept therapy .\
RESULTS	The longest individual treatment was 8.2 years , with 3139 total patient-years of etanercept exposure .\
RESULTS	Rates of serious adverse events ( overall rate = 14.8 events/100 patient-yrs ) , serious infections ( overall rate = 4.2 events/100 patient-yrs ) , cancer ( overall rate = 1.0 events/100 patient-yrs ) , and deaths ( overall rate = 0.7 events/100 patient-yrs ) were stable each year , through 8 years of etanercept exposure .\
RESULTS	For 356 patients who completed 6 years of etanercept treatment , response rates were ACR20 = 73 % , ACR50 = 52 % , ACR70 = 27 % , DAS28 CRP good response = 52 % , and DAS28 CRP remission = 37 % of patients .\
RESULTS	Similar responses occurred in 167 patients who completed Year 7 .\
RESULTS	Doses of concomitant methotrexate or corticosteroids were reduced in many patients who maintained clinical responses .\
CONCLUSIONS	The safety profile of etanercept was consistent over time , with rates of adverse events similar to those reported for patients with RA in general .\
CONCLUSIONS	Durable clinical responses were observed in some patients for 7 years or more .\
CONCLUSIONS	The benefit-to-risk ratio for longterm etanercept treatment remains highly favorable .\
\
###23605175\
BACKGROUND	The reduction in adrenergic activity and anxiety associated with meditation may be beneficial for patients with implantable cardioverter defibrillators .\
OBJECTIVE	This study aims to determine the feasibility of a phone-delivered mindfulness intervention in patients with defibrillators and to obtain preliminary indications of efficacy on mindfulness and anxiety .\
METHODS	Clinically stable outpatients were randomized to a mindfulness intervention ( eight weekly individual phone sessions ) or to a scripted follow-up phone call .\
METHODS	We used the Hospital Anxiety and Depression Scale and the Five Facets of Mindfulness to measure anxiety and mindfulness , and multivariate linear regression to estimate the intervention effect on pre-post-intervention changes in these variables .\
RESULTS	We enrolled 45 patients ( 23 mindfulness and 22 control ; age , 43-83 ; 30 % women ) .\
RESULTS	Retention was 93 % ; attendance was 94 % .\
RESULTS	Mindfulness ( beta = 3.31 ; p = 0.04 ) and anxiety ( beta = -1.15 ; p = 0.059 ) improved in the mindfulness group .\
CONCLUSIONS	Mindfulness training can be effectively phone-delivered and may improve mindfulness and anxiety in cardiac defibrillator outpatients .\
\
###8219523\
OBJECTIVE	To evaluate the effects of different frequencies of auricular ( ear-to-ear ) sine-wave transcutaneous electrical nerve stimulation ( TENS ) , administered at subliminal intensity , on trigeminal nerve sensitivity .\
METHODS	In a double-blind protocol , healthy volunteer subjects were administered one of three different frequencies of active TENS ( 5 , 100 , or 2,000 Hz ) or placebo TENS ( no current was passed ) for 30 min .\
METHODS	Department of Psychology , City University of New York .\
METHODS	72 healthy undergraduate volunteers with no preexisting pain problems ( 16 men and 56 women ) , from the Department of Psychology , City University of New York .\
METHODS	Pretreatment to posttreatment changes were measured in sensation threshold for a 250-Hz electrical stimulus applied transcutaneously to an area 1 cm anterior to the tragus of the ear ( mandibular division of the trigeminal nerve ) .\
RESULTS	Analysis of variance indicated no group differences in baseline trigeminal sensation threshold , but there were significant group differences in pretreatment to posttreatment changes in sensation threshold ( p < 0.001 ) .\
RESULTS	A postiori analysis showed significant increases in trigeminal sensation threshold after active TENS as compared to placebo TENS ( p < 0.05 ) , with 5 - and 100-Hz TENS producing significantly greater hypesthesia than 2,000-Hz TENS ( p < 0.05 ) .\
CONCLUSIONS	Sine-wave auricular TENS produces frequency-dependent trigeminal hypesthesia that is not a placebo effect .\
\
###9424002\
OBJECTIVE	Clinical trials have demonstrated that high dose radiation therapy and daily cisplatin ( CDDP ) could increase local control and survival in carcinoma from various sites .\
OBJECTIVE	The present phase I-II study has combined high dose radiation therapy and daily CDDP at escalating dosages .\
METHODS	From August 1994 to December 1995 , 23 patients with non-resectable carcinoma of the pancreas were enrolled in a phase I-II multicentric , pilot study to test the toxicity and the effectiveness of high dose radiotherapy and daily cisplatin ( CDDP ) at escalating dosages .\
METHODS	A dose of 6 mg/sqm/day of CDDP was selected for the phase II step since no grade IV toxicity occurred in any patient in the phase I step .\
RESULTS	Toxicity was considered fairly acceptable .\
RESULTS	At the time of analysis , the 23 patients who entered the study had clear evidence of evolutive disease either locally or distantly in the liver .\
RESULTS	It is suggested that high dose radiotherapy ( 60 Gy continuously ) and daily CDDP have little effect on local control of the tumor and survival , and only a moderate effect on pain .\
CONCLUSIONS	In unresectable , apparently non-metastatic cancers of the pancreas , there is an urgent need for new agents or new combinations of agents to be tested .\
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###9396886\
OBJECTIVE	Our purpose was to determine significant predictors for the development of clinical chorioamnionitis and postpartum fever in patients with prelabor rupture of membranes at term .\
METHODS	Logistic regression analysis with odds ratios and 95 % confidence intervals was used to determine the significant predictors of clinical chorioamnionitis and postpartum fever in women with prelabor rupture of membranes at term enrolled in this study .\
METHODS	The study recently compared in a randomized controlled trial four strategies of management : induction with oxytocin , induction with prostaglandin , expectant management , and , if failed , induction with oxytocin or prostaglandin .\
RESULTS	The following variables were significantly associated with clinical chorioamnionitis : ( 1 ) number of digital vaginal examinations : > 8 , 7 to 8 , 5 to 6 , 3 to 4 ( vs 0 to 2 ) ( odds ratio 5.07 , 3.80 , 2.62 , 2.06 ) ; ( 2 ) duration of active labor : > or = 12 , 9 to < 12 , 6 to < 9 hours ( vs < 3 hours ) ( odds ratio 4.12 , 2.94 , 1.97 ) ; ( 3 ) meconium-stained amniotic fluid ( odds ratio 2.28 ) ; ( 4 ) parity of 0 ( odds ratio 1.80 ) ; ( 5 ) time from membrane rupture to active labor : > or = 48 , 24 to < 48 hours ( vs < 12 hours ) ( odds ratio 1.76 , 1.77 ) ; and ( 6 ) group B streptococcal colonization ( odds ratio 1.71 ) .\
RESULTS	Variables significantly associated with postpartum fever were ( 1 ) clinical chorioamnionitis ( odds ratio 5.37 ) , ( 2 ) duration of active labor : > or = 12 , 9 to < 12 , 6 to < 9 , 2 to < 6 hours ( vs < 3 hours ) ( odds ratio 4.86 , 3.53 , 3.46 , 3.04 ) , ( 3 ) cesarean section , operative vaginal delivery ( odds ratio 3.97 , 1.86 ) , ( 4 ) group B streptococcal colonization ( odds ratio 1.88 ) , and ( 5 ) maternal antibiotics before delivery ( odds ratio 1.94 ) .\
CONCLUSIONS	Increasing numbers of digital vaginal examinations , longer duration of active labor , and meconium staining of the amniotic fluid were the most important risk factors for the development of clinical chorioamnionitis in women with prelabor rupture of membranes at term .\
CONCLUSIONS	The most important risk factors for the development of postpartum fever were clinical chorioamnionitis , increasing duration of active labor , and cesarean section delivery .\
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###8202978\
OBJECTIVE	Alterations of gait cycle and foot-drop on the paretic limb are characteristic of stroke patients .\
OBJECTIVE	Electromyographic biofeedback treatment has been used in rehabilitation of walking , but results are controversial .\
OBJECTIVE	We performed gait analysis to evaluate the efficacy of electromyographic biofeedback compared with physical therapy .\
METHODS	Sixteen patients with ischemic stroke were enrolled in the study .\
METHODS	The experimental group ( 4 men , 4 women ) received electromyographic biofeedback treatment together with physical therapy .\
METHODS	The control group ( 5 men , 3 women ) was treated with physical therapy only .\
METHODS	Clinical and functional evaluations before and after treatment were performed using Canadian Neurological , Adams , Ashworth , Basmajian , and Barthel Index scales .\
METHODS	Computerized gait analysis was performed in all patients .\
RESULTS	Electromyographic biofeedback patients showed significantly increased scores on the Adams scale ( P < .05 ) and Basmajian scale ( P < .01 ) .\
RESULTS	Gait analysis in this group showed a recovery of foot-drop in the swing phase ( P < .02 ) after training .\
CONCLUSIONS	Our data confirm that the electromyographic biofeedback technique increases muscle strength and improves recovery of functional locomotion in patients with hemiparesis and foot-drop after cerebral ischemia .\
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###19019730\
BACKGROUND	Crataegus preparations have been used for centuries especially in Europe .\
BACKGROUND	To date , no proper data on their efficacy and safety as an add-on-treatment are available .\
BACKGROUND	Therefore a large morbidity/mortality trial was performed .\
OBJECTIVE	To investigate the efficacy and safety of an add-on treatment with Crataegus extract WS 1442 in patients with congestive heart failure .\
METHODS	In this randomised , double-blind , placebo-controlled multicenter study , adults with NYHA class II or III CHF and reduced left ventricular ejection fraction ( LVEF < or = 35 % ) were included and received 900 mg/day WS 1442 or placebo for 24 months .\
METHODS	Primary endpoint was time until first cardiac event .\
RESULTS	2681 patients ( WS 1442 : 1338 ; placebo : 1343 ) were randomised .\
RESULTS	Average time to first cardiac event was 620 days for WS 1442 and 606 days for placebo ( event rates : 27.9 % and 28.9 % , hazard ratio ( HR ) : 0.95 , 95 % CI [ 0.82 ; 1.10 ] ; p = 0.476 ) .\
RESULTS	The trend for cardiac mortality reduction with WS 1442 ( 9.7 % at month 24 ; HR : 0.89 [ 0.73 ; 1.09 ] ) was not statistically significant ( p = 0.269 ) .\
RESULTS	In the subgroup with LVEF > or = 25 % , WS 1442 reduced sudden cardiac death by 39.7 % ( HR 0.59 [ 0.37 ; 0.94 ] at month 24 ; p = 0.025 ) .\
RESULTS	Adverse events were comparable in both groups .\
CONCLUSIONS	In this study , WS 1442 had no significant effect on the primary endpoint .\
CONCLUSIONS	WS 1442 was safe to use in patients receiving optimal medication for heart failure .\
CONCLUSIONS	In addition , the data may indicate that WS 1442 can potentially reduce the incidence of sudden cardiac death , at least in patients with less compromised left ventricular function .\
\
###17435518\
OBJECTIVE	To assess the corneal swelling response to two myopic correction corneal refractive therapy ( CRT ) lenses of varying Dk/t values , worn for a single night .\
OBJECTIVE	Change in thickness of the total cornea , stroma , and epithelium was measured across the horizontal meridian using optical coherence tomography ( OCT ) .\
METHODS	In this double-masked , randomized study , twenty subjects wore a CRT design lens in each eye , manufactured from Menicon Z ( MenZ ; Dk/t = 91 ) and Equalens II ( EqII ; Dk/t = 47 ) materials .\
METHODS	Baseline corneal thickness was measured centrally and at four points either side of the central cornea using OCT , the night before sleeping at the Centre for Contact Lens Research .\
METHODS	The next morning , lenses were removed , and thickness measurements were repeated 1 , 3 , 6 , and 12 h after removal .\
RESULTS	On lens removal , the MenZ eye had central and paracentral corneal swelling ( mean + / - SD ) of 4.1 + / - 2.0 % and 5.6 + / - 2.4 % , and the EqII eye had 5.8 + / - 2.6 % and 7.0 + / - 2.6 % .\
RESULTS	These values were significantly different from baseline ( ReANOVA ; p < 0.001 ) and were different between lens materials ( p < 0.001 ) .\
RESULTS	The central epithelium thinned by 10.0 + / - 4.5 % in the MenZ eye and by 10.2 + / - 8.5 % in the EqII eye , with the mid-peripheral epithelium thickening by 13.4 + / - 7.9 % in the MenZ eye and 18.3 + / - 9.8 % in the EqII eye ( all changes different from baseline p < 0.001 ) .\
RESULTS	These epithelial values were not statistically different between materials ( p > 0.05 ) .\
RESULTS	Stromal swelling values on lens removal were 5.7 + / - 2.2 % centrally and 5.5 + / - 3.0 % mid-peripherally ( MenZ ) and 7.7 + / - 3.1 % centrally and 6.6 + / - 2.9 % mid-peripherally ( EqII ) ( all p < 0.001 from baseline ) .\
RESULTS	Central stromal swelling was different between eyes at lens removal ( p < 0.001 ) .\
RESULTS	Stromal thickness in both eyes returned to baseline values within 3 h.\
CONCLUSIONS	The higher-Dk/t MenZ material caused significantly less overnight corneal and stromal swelling than the Eqll material , which reinforces the need to prescribe lenses with high Dk/t for overnight wear .\
CONCLUSIONS	Neither central epithelial thinning nor paracentral thickening are significantly affected by Dk/t .\
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###19103321\
OBJECTIVE	Dietary interventions with children often use self-reported data to assess efficacy despite that objective methods rarely support self-report findings in validation studies .\
OBJECTIVE	This study compared fourth graders ' self-reported to observed lunch fruit and vegetable intake to determine if the accuracy of self-reported intake varied by treatment condition .\
METHODS	Matched randomized follow-up design examined three treatment groups ( high and low intensity interventions and control ) post-intervention .\
METHODS	Three hundred seventy-nine middle-school children participating in a randomized controlled trial of a school-based fruit and vegetable intervention were observed during school lunch one day and asked to recall intake the following day .\
METHODS	Food items were coded as : `` match , '' `` omission , '' or `` intrusion . ''\
METHODS	Students were classified as accurate if all food items matched , otherwise inaccurate .\
METHODS	Matched foods ' portions were compared for accuracy .\
METHODS	Servings were computed for total fruit and vegetable intake .\
METHODS	Accuracy for fruits and vegetables were compared in separate analyses and tested for multiple potential associates : treatment condition , sex , race , body mass index , subsidized meal eligibility , school district , fruit/vegetable availability , age , and test scores .\
METHODS	Fitted multivariable regression models included variables found to be significant in univariate or chi ( 2 ) analyses .\
RESULTS	Variables found to be significant for fruit item accuracy were availability at lunch , body mass index , and subsidized lunch eligibility .\
RESULTS	For vegetable item accuracy , availability at lunch was significant .\
RESULTS	No differences were found for food portions or for efficacy of the intervention between the two methods of dietary data collection : observation and self-report .\
CONCLUSIONS	Condition assignment did not bias recalled fruit and vegetable intakes among fourth graders .\
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###16082604\
BACKGROUND	Once - and twice-daily low-molecular-weight heparin administered in hospital have been shown to be effective and safe for treating deep-vein thrombosis .\
BACKGROUND	The aim of this study was to compare the efficacy and safety of deep-vein thrombosis treatment using once-daily subcutaneous enoxaparin in the outpatient setting with intravenous unfractionated heparin in hospital .\
METHODS	This randomized , parallel-group , open-label study was conducted in 18 centers in 4 countries .\
METHODS	In total , 298 patients with symptomatic deep-vein thrombosis who were eligible for home treatment were randomized to treatment with enoxaparin in the outpatient setting ( 1.5 mg/kg subcutaneously once-daily ) or unfractionated heparin in hospital ( 5000 IU bolus and 1250 IU/hour intravenous infusion ) for > or = 5 days .\
METHODS	Clinical endpoints were assessed during a 6-month follow-up period .\
RESULTS	Among all patients treated with enoxaparin , there was a trend towards fewer recurrent deep-vein thromboses ( 1.3 % vs. 5.4 % ; p = 0.060 ) and pulmonary emboli ( 1.3 % vs. 4.1 % ; p = 0.17 ) compared with patients treated with unfractionated heparin .\
RESULTS	When considering a post-hoc combined endpoint of deep-vein thrombosis and pulmonary embolism , significantly fewer events occurred in the enoxaparin group than in the unfractionated-heparin group ( 2.7 % vs. 8.8 % ; p = 0.026 ) .\
RESULTS	The incidences of bleeding events and adverse events in the enoxaparin and unfractionated-heparin groups were similar .\
CONCLUSIONS	Once-daily subcutaneous enoxaparin in the outpatient setting is at least as effective and as well tolerated as in-hospital intravenous unfractionated heparin for treatment of deep-vein thrombosis .\
\
###12006715\
OBJECTIVE	To assess whether complete kangaroo mother care ( KMC ) , a skin-to-skin contact intervention , would affect longitudinal/developmental patterns of hormonal change .\
METHODS	An open randomized controlled trial was conducted in a large tertiary care hospital , comparing KMC and traditional care for newborn infants weighing less than 2,001 g. Eighty-seven healthy preterm ( < 37 weeks gestational age ) infants from this study provided three blood-spot samples on filter paper : at randomization ( postnatal age 1-5 days ) , 2 weeks later , and at calculated term ( 41 weeks gestational age ) .\
METHODS	They met a number of additional inclusion criteria including discharge from the hospital within the first postnatal week .\
METHODS	The levels of 17alpha-hydroxy-progesterone ( 17-OHP ) , thyroxine-stimulating hormone ( TSH ) and thyroxine ( T ( 4 ) ) were assessed by radioimmunoassay .\
METHODS	Birth weight ( < 1,800 or > or = 1,800 g ) and prenatal maternal corticosteroid treatment were taken into account in the analysis .\
METHODS	Complete KMC includes early discharge , positioning the infant on the parent 's chest in an upright position , 24 h/day in skin-to-skin contact , and breast-feeding .\
METHODS	In the traditional care group , infants were discharged according to routine hospital practice .\
RESULTS	Levels of 17-OHP and TSH decreased significantly from eligibility to calculated term while T ( 4 ) levels did not change significantly over time .\
RESULTS	Most importantly , overall , treatment ( KMC ) did not interact with the pattern of physiological change .\
CONCLUSIONS	Maturation of the pituitary-thyroid axis and adrenal function is apparently not compromised by KMC , at least in healthy preterm infants .\
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###21049628\
OBJECTIVE	To explore the role of Tong Mai Tang & Lornoxicam on the serum concentrations of tumor necrosis factor alpha ( TNF-alpha ) , interleukin ( IL-6 ) , D-dipolymer ( D-Di ) , Platelet count ( PLC ) in treatment of femoral shaft fracture among period surgery time .\
METHODS	We selected 120 cases of traumatic femoral shaft fracture patients according to the inclusion criteria and exclusion criteria , which were randomized dividend into four groups ( I , II , III , IV respectively ) of the same size based on the random number table method of 30 patients each .\
METHODS	Therapeutic methods of four groups following as : Group I , Tpanax Notoginseng Pills PO ; Group II , Tpanax Notoginseng Pills PO , Lornoxicam For Injection , 8 mg IM ; Group III , Tpanax Notoginseng Pills PO , Tong Mai Decoctions 200 mL PO ; Group IV , Tpanax Notoginseng Pills PO , Lornoxicam For Injection 8 mg IM , Tong Mai Decoctions 200 mL PO .\
METHODS	The above medications were administered to the four groups after admission to hospital the next day .\
METHODS	Peripheral blood samples were taken for immune determination of pro-inflammatory cytokines of TNF-alpha , IL-6 , D-Di , PLC in blood serum on the 2nd and 6th day before operation and on the 8th and 13th day after operation in the morning .\
METHODS	And all patients received liver and kidney function examination 2nd and 13th day after admission .\
METHODS	Analysis of variance and least significant difference-test were done with the help of SPSS 17.0 statistic software .\
RESULTS	The difference among four groups in TNF-alpha and IL-6 were significant ( P < 0.05 ) .\
RESULTS	And there were also significant statistic difference between group II/III/IV and group I group ( P < 0.05 ) .\
RESULTS	But the difference between group II and group III was insignificant ( P > 0.05 ) .\
RESULTS	However , the group contrast result between group IV and group II/III had statistics difference ( P < 0.05 ) .\
RESULTS	The difference in D-Di PLC at 6th day and 8th day were significant ( P < 0.05 ) .\
RESULTS	The group comparisons in group I/II/IV were also significant .\
RESULTS	There were non-statistics significance in group II compared 6th day/8th day with 2nd day ( P > 0.05 ) .\
RESULTS	The comparison between the 13th day with the first three time sections had statistics significance .\
RESULTS	And there were statistics significance at the 13th day between group IV and group II ( P < 0.05 ) .\
CONCLUSIONS	The serum concentrations of TNF-alpha , IL-6 , D-Di and PLC level were significantly increased in peroperative period , These results seem to indicate that the Tong Mai Decoctions & Lornoxicam may play an important role in inhibiting the release of TNF-alpha , IL-6 , D-Di and PLC into the blood stream and decreasing the incunabula complication at early traumatic stage .\
CONCLUSIONS	The Tong Mai Decoctions & Lornoxicam was the worth promoting screened China and the West union medication combination .\
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###19181715\
BACKGROUND	It is well recognized that physical activity ( PA ) is important for older adults ; yet , clinicians remain pessimistic about the ability of older adults with compromised function to adhere to long-term treatment and to maintain behavior change once treatment has been terminated .\
METHODS	We examined the functional status of older adults at a field center ( Wake Forest University ) 2 years after completing 12 months of treatment in the Lifestyle Interventions and Independence for Elders Pilot study .\
METHODS	At baseline , participants were randomized to either a PA or a successful aging ( SA ) control group .\
METHODS	Outcome measures included an interview assessment of PA , the Short Physical Performance Battery ( SPPB ) , and performance on a 400-m self-paced walking test .\
RESULTS	Two years after the formal intervention had ended , participants who were originally in the PA group continued to engage in more minutes of moderate PA and tended to have better SPPB and walking speed than those in the SA group ( effect sizes [ ES ] : SPPB = 0.40 , walking speed = 0.37 ) .\
RESULTS	Seven ( 12.7 % ) participants in the PA group failed the 400-m walk at the 36-month follow-up assessment , whereas this number was 11 ( 21.6 % ) in the SA group .\
CONCLUSIONS	Older adults who have compromised physical function are able to sustain some of the benefits derived from participating in structured PA 2 years after supervised treatment has been terminated .\
\
###21489882\
BACKGROUND	Male circumcision reduces the transmission of high-risk human papillomavirus ( HPV ) in HIV-uninfected men and their female partners .\
BACKGROUND	We assessed whether circumcision of HIV-infected men would reduce the transmission of high-risk HPV to their female partners .\
METHODS	Female partners of HIV-infected men ( aged 15-49 years ) in Rakai , Uganda , with CD4 counts of greater than 350 cells per mL who were randomly assigned to undergo circumcision immediately ( intervention group ) and after 24 months ( control group ) were assessed for infection with high-risk HPV .\
METHODS	Randomisation was done in blocks of 20 , stratified by community , with computer-generated random numbers .\
METHODS	Laboratory technicians and female fieldworkers were masked to the circumcision status of male participants .\
METHODS	The main outcome assessed in this study was the effects of circumcision of HIV-infected men on transmission of HPV to their female partners .\
METHODS	Analysis was by intention to treat .\
METHODS	The trial is registered with ClinicalTrials.gov , number NCT00124878 .\
RESULTS	474 men were assigned to the intervention group , 448 to the control group .\
RESULTS	211 women were in consensual relationships with 193 men in the intervention group , and 171 women were in consensual unions with 155 men in the control group .\
RESULTS	High-risk HPV at the 2-year follow-up was prevalent in 88 female partners ( 55 % ) of 159 men in the intervention group and 68 ( 52 % ) of 131 female partners of men in the control group ( prevalence risk ratio 107 , 95 % CI 086-132 , p = 064 ) .\
RESULTS	Incidence of high-risk HPV over 2 years was 320 per 100 person-years in the female partners of men in the intervention group and 306 per 100 person-years in the female partners of men in the control group ( incidence rate ratio 105 , 077-143 , p = 078 ) .\
RESULTS	No difference was noted in the clearance of genotype-specific high-risk HPV between the intervention group ( 196 [ 46 % ] of 424 ) and control group ( 167 [ 48 % ] of 347 ; rate ratio 096 , 083-112 ; p = 061 ) .\
CONCLUSIONS	Because circumcision of HIV-infected men did not affect transmission of high-risk HPV to their female partners , promotion of consistent safe sexual practices for HIV-infected men remains important .\
BACKGROUND	Bill & Melinda Gates Foundation and National Institutes of Health .\
\
###16083542\
OBJECTIVE	Randomised controlled trials that directly compare cholinesterase inhibitors for the treatment of Alzheimer 's disease have been characterised by significant methodological limitations .\
OBJECTIVE	As a consequence , they have failed to establish whether there are differences between agents in this class .\
OBJECTIVE	To help address this question , a double-blind , randomised , controlled , multicentre trial was designed to evaluate the efficacy and tolerability of cholinesterase inhibitor treatment in patients with moderate to moderately-severe Alzheimer 's disease over a 2-year period .\
METHODS	Patients were randomly assigned to rivastigmine 3-12 mg/day or donepezil 5-10 mg/day .\
METHODS	Efficacy measures comprised assessments of cognition , activities of daily living , global functioning and behavioural symptoms .\
METHODS	Safety and tolerability assessments included adverse events and measurement of vital signs .\
RESULTS	In total , 994 patients received cholinesterase inhibitor treatment ( rivastigmine , n = 495 ; donepezil , n = 499 ) , and 57.9 % of patients completed the study .\
RESULTS	The most frequent reason for premature discontinuation in both treatment groups was adverse events , primarily gastrointestinal .\
RESULTS	Adverse events were more frequent in the rivastigmine group during the titration phase , but similar in the maintenance phase .\
RESULTS	Serious adverse events were reported by 31.7 % of rivastigmine - and 32.5 % of donepezil-treated patients , respectively .\
RESULTS	Rivastigmine and donepezil had similar effects on measures of cognition and behaviour , but rivastigmine showed a statistically significant advantage on measures of activities of daily living and global functioning in the ITT-LOCF population .\
RESULTS	However , this was not maintained in the non-ITT-LOCF populations .\
RESULTS	In secondary subgroup analyses , AD patients who had genotypes that encoded for full expression of the butyrylcholinesterase enzyme ( BuChE wt/wt ; n = 226/340 ) , who were < 75 years of age ( n = 362/994 ) or who had symptoms suggestive of concomitant Lewy body disease ( n = 49/994 ) showed significantly greater benefits from rivastigmine treatment .\
CONCLUSIONS	Cholinesterase inhibitor treatment may offer continued therapeutic benefit for up to 2 years in patients with moderate AD .\
CONCLUSIONS	Although both drugs performed similarly on cognition and behaviour , rivastigmine may provide greater benefit in activities of daily living and global functioning .\
\
###12853831\
OBJECTIVE	Many children with urinary tract infections and vesicoureteral reflux require catheterization .\
OBJECTIVE	Catheterization can be a painful experience , and a desire to avoid this experience may affect patient care .\
OBJECTIVE	We evaluated the effectiveness of lubricant containing lidocaine for minimizing patient pain and distress during catheterization .\
METHODS	We conducted a prospective , double-blind , placebo controlled trial .\
METHODS	Twenty children ( 16 girls and 4 boys , mean age 7.7 years ) had urethral lubricant with or without lidocaine placed within 10 minutes before urethral catheterization .\
METHODS	In all children pre-procedure anxiety , and pain and distress during catheterization were recorded .\
METHODS	Pre-procedure anxiety was measured using a visual analog scale , pain was measured with the Oucher Pain Scale and distress was recorded by 2 independent observers with a simple 7-point Likert-type scale .\
RESULTS	There were no significant group differences for age , number of previous catheterizations or pre-procedure anxiety .\
RESULTS	The group receiving lubricant with lidocaine had significantly lower pain ( 21 + / - 19.69 versus 65.5 + / - 26.29 ) and distress ( 2.65 + / - 1.97 versus 4.7 + / - 2.07 ) ( p = 0.001 and 0.007 , respectively ) .\
CONCLUSIONS	The use of lubricant with lidocaine significantly decreases pain with pediatric urethral catheterization and is recommended with pediatric catheterizations .\
\
###23082885\
OBJECTIVE	The authors evaluated the effects of acetylsalicylic acid ( ASA ) usage and transfusion of previously frozen apheresis platelets on postoperative hemorrhage , activities of daily living ( ADL ) score , and mortality rate in patients with acute hypertensive basal ganglia hemorrhage undergoing craniotomy .\
METHODS	This was a prospective , double-blind , parallel , randomized controlled trial in patients with acute hypertensive basal ganglia hemorrhage , who had either not received ASA therapy ( control ) or received ASA therapy .\
METHODS	The patients who received ASA therapy were divided according to the results of a platelet aggregation test into ASA-resistant , ASA-semiresponsive , and ASA-sensitive groups .\
METHODS	All patients required an emergency craniotomy for hematoma removal after hospitalization .\
METHODS	The patients who were sensitive to ASA were randomized to receive one of the following transfusion regimens of previously frozen apheresis platelets : no transfusion , 1 therapeutic dose before surgery , or 2 therapeutic doses ( 1 before surgery and 1 after 24 hours of hospitalization ) .\
METHODS	The postoperative hemorrhage rate and the average postoperative hemorrhage volume were recorded and the ADL scores and mortality rate were measured during a 6-month follow-up period .\
RESULTS	The rate of postoperative hemorrhage , average postoperative hemorrhage volume , and mortality rate were significantly higher in the ASA-sensitive patients who received ASA therapy compared with patients who did not receive ASA therapy ( all p < 0.005 ) .\
RESULTS	The ADL scores were grouped into different grades and the number of cases in the lower grades was higher and the overall scores were poorer in patients who received ASA therapy compared with those who did not ( all p < 0.005 ) .\
RESULTS	After transfusion of previously frozen apheresis platelets , the postoperative hemorrhage rate , average postoperative hemorrhage volume , and mortality rate of the ASA-sensitive patients were significantly lowered ( all p < 0.005 ) , and the ADL scores and their classification level were better than those of patients who did not undergo transfusion ( all p < 0.005 ) .\
CONCLUSIONS	Transfusion of previously frozen apheresis platelets reduces the rate of postoperative hemorrhage , average postoperative hemorrhage volume , disability rate , and mortality rate in ASA-sensitive patients with acute hypertensive basal ganglia hemorrhage undergoing craniotomy .\
\
###10443734\
OBJECTIVE	To evaluate tumor cell proliferation in relation to histopathologic regressive changes and failure after radical prostatectomy after a 3-month course of neoadjuvant luteinizing hormone-releasing hormone ( LHRH ) analogue treatment .\
METHODS	We evaluated slides from 103 radical prostatectomy specimens of the 111 patients participating in a randomized trial of a 3-month course of neoadjuvant LHRH analogue treatment before radical retropubic prostatectomy ( n = 50 ) versus surgery alone ( n = 53 ) .\
METHODS	The histopathologic regressive changes in the specimens were scored by two pathologists .\
METHODS	Sections were stained with the anti-Ki-67 monoclonal antibody MIB-1 .\
METHODS	The proliferation index ( PI ) was defined as the proportion of Ki-67-positive cells in a random cell count .\
METHODS	The patients were followed up until treatment failure or for a mean of 39 months among those without failure .\
RESULTS	In the neoadjuvant group , increasing histopathologic regressive changes correlated with a decrease in capsular penetration , positive surgical margins , and tumor cell proliferation but did not correlate with Gleason score in biopsies .\
RESULTS	Treatment failure was not related to the histopathologic regressive changes .\
RESULTS	In the neoadjuvant treatment group , progression-free survival was longer in the subgroup of patients with tumors with a PI less than 1.2 % compared with those with tumors with a PI greater than 1.2 % ( P = 0.02 ) .\
RESULTS	Multivariate analysis of PI and histopathologic and clinical features showed the PI ( P = 0.002 ) and the pretreatment serum prostate-specific antigen level ( P = 0.003 ) to be significant prognostic markers of failure in the neoadjuvant group .\
CONCLUSIONS	Tumor cell proliferation after 3 months of neoadjuvant hormonal treatment is a prognostic marker of failure after radical prostatectomy without correlation to Gleason score or the histopathologic regressive changes resulting from hormonal treatment .\
\
###17432689\
OBJECTIVE	To observe the effects of therapeutic method of expelling wind , eliminating phlegm and promoting blood circulation ( EWEPPB ) in treating acute cerebral infarction ( ACI ) depending on the clinical and data platform of stroke clinical unit .\
METHODS	ACI patients were randomly assigned to the control group ( 36 cases ) treated by routine Western therapy alone and the treatment group ( 32 cases ) with routine therapy plus Chinese medicinal compound for EWEPPB .\
METHODS	The treatment course was 14 days .\
METHODS	The scores of TCM symptom , the NIH stroke scale ( NIHSS ) , and Barthel index ( BI ) were used for evaluating the effect of treatment .\
RESULTS	The scores of TCM symptom and NIHSS decreased , and that of BI increased after treatment in both groups , and the treatment in the treatment group showed a effect significantly better than that in the control group ( P < 0.05 ) .\
CONCLUSIONS	EWEPPB is effective method in treating ACI , traditional Chinese compounds for EWEPPB could play a positive role in the stroke unit .\
\
###21875638\
BACKGROUND	While three types of hepatitis A vaccines are available in China , little data are available to compare them in terms of early antibody response .\
BACKGROUND	We conducted a trial to compare antibody response at 7 , 14 and 28 days .\
METHODS	We randomized primary school children in Gansu and Jilin provinces into four groups to receive either ( 1 ) Chinese live attenuated hepatitis A vaccine ( H2 strain ) , ( 2 ) domestic inactivated hepatitis A vaccine ( Healive ( ) ) , ( 3 ) imported inactivated hepatitis A vaccine ( Havrix ( ) ) or ( 4 ) hepatitis B vaccine ( Control group ) .\
METHODS	We compared groups at 7 , 14 and 28 days in terms of proportion of sero-conversions ( 10 mUI/ml ) , and Geometric Mean Concentration ( GMC ) of antibodies measured with a Microparticle Enzyme Immunoassay ( MEIA ) .\
METHODS	We compared rates of self-reported adverse events following immunization ( AEFI ) in the first three days .\
RESULTS	204 children received the H2 vaccine , 208 received Healive ( ) , 214 received Havrix ( ) , and 215 received hepatitis B vaccine ( no differences across groups in terms of age , sex , weight and height ) .\
RESULTS	At seven days , sero-conversion proportions were 25 % , 35 % , 27 % and 2 % ( p < 0.0001 ) with GMC of 6 mIU/ml , 8 mIU/ml , 6 mIU/ml and 3 mIU/ml , respectively for the four groups .\
RESULTS	At 28 days , sero-conversion proportions were 98 % , 100 % , 93 % and 3 % ( p < 0.0001 ) with GMC of 47 mIU/ml , 71 mIU/ml , 67 mIU/ml and 3 mIU/ml , respectively .\
RESULTS	AEFI were benign and did not differ across groups ( p = 0.94 ) .\
CONCLUSIONS	While our study was not able to identify differences between Havrix ( ) , Healive ( ) and H2 vaccine in terms of sero-conversion proportion and GMC between seven and 28 days , further studies should evaluate non-inferiority or equivalence of the Chinese vaccines , particularly with respect to the GMC concentration for the H2 vaccine since it could affect long-term protection .\
\
###22038523\
OBJECTIVE	Conflicting data regarding cardiovascular effects of thiazolidinediones ( TZDs ) and extra-skeletal effects of vitamin D supported the need for a definitive trial .\
OBJECTIVE	The Thiazolidinedione Intervention with vitamin D Evaluation ( TIDE ) trial aimed to assess the effects of TZDs ( rosiglitazone and pioglitazone ) on cardiovascular outcomes and the effects of vitamin D ( cholecalciferol ) on cancers and mortality .\
METHODS	A large multicentre 3 2 factorial double-blind placebo-controlled randomised trial recruited from outpatient primary care and specialty clinics in 33 countries .\
METHODS	From June 2009 to July 2010 , 1,332 people with type 2 diabetes and other cardiovascular risk factors aged 50 years whose HbA ( 1c ) was 6.5-9 .5 % ( 48-80 mmol/mol ) when using two or fewer glucose-lowering drugs were randomised by a central computer system to placebo ( n = 541 ) , rosiglitazone 4-8 mg/day ( n = 399 ) or pioglitazone 30-45 mg/day ( n = 392 ) ; 1,221 participants were randomised to placebo ( n = 614 ) or vitamin D 1,000 IU/day ( n = 607 ) .\
METHODS	Participants and all study personnel were blind to treatment allocation .\
METHODS	The primary outcome for the TZD arm was the composite of myocardial infarction , stroke or cardiovascular death , and for the vitamin D arm it was cancer or all-cause death .\
METHODS	All randomised participants were included in the primary analysis .\
RESULTS	From the study design , 16,000 people were to be followed for approximately 5.5 years .\
RESULTS	However , the trial was stopped prematurely because of regulatory concerns after a mean of 162 days without consideration of the accrued data .\
RESULTS	In the TZD arm , the cardiovascular outcome occurred in five participants ( 0.9 % ) in the placebo groups and three participants ( 0.4 % ) in the TZD groups ( two allocated to pioglitazone , one to rosiglitazone ) .\
RESULTS	In the vitamin D arm , the primary outcome occurred in three participants ( 0.5 % ) in the placebo group and in two participants ( 0.3 % ) receiving vitamin D. Adverse events were comparable in all groups .\
CONCLUSIONS	Uncertainty persists regarding the clinically relevant risks and benefits of TZDs and vitamin D because of the early cancellation of this comprehensive trial .\
\
###12585827\
BACKGROUND	Even after the surgical or medical treatment of hepatocellular carcinoma , tumors frequently develop at new foci , leading to a poor prognosis .\
OBJECTIVE	To assess whether combined tumor ablation and interferon therapy can reduce the occurrence of new foci of hepatocellular carcinoma , thereby improving survival rate .\
METHODS	Randomized , controlled study .\
METHODS	University hospital .\
METHODS	74 patients with compensated cirrhosis , three or fewer nodules of hepatocellular carcinoma , and low hepatitis C virus RNA loads ( < or = 2 x 10 ( 6 ) copies/mL ) .\
METHODS	After all patients had complete ablation of lesions by percutaneous ethanol injection therapy , 49 patients were assigned to receive 6 million U of interferon three times weekly for 48 weeks and 25 did not receive treatment .\
METHODS	Abdominal ultrasonography , computed tomography , and determination of blood biochemical measures .\
RESULTS	Of the 49 patients treated with interferon , 21 showed a sustained biochemical response and 14 showed a sustained virologic response .\
RESULTS	The rate of first recurrence of new foci of hepatocellular carcinoma was similar in patients treated with interferon and untreated patients ; however , the rates of second or third recurrence seemed to be lower in the interferon group than in the untreated group .\
RESULTS	Patients treated with interferon had a survival rate of 68 % at 5 years and 53 % at 7 years ; untreated patients had a survival rate of 48 % at 5 years and 23 % at 7 years .\
CONCLUSIONS	After tumor ablation by ethanol injection , interferon therapy may enhance patient survival in selected patients with chronic hepatitis C.\
\
###7487242\
BACKGROUND	The wider use of written advance directives is popular but problematic .\
BACKGROUND	We have shown previously that acute hospitalization in the era of the Patient Self-Determination Act can facilitate directive discussions and documentation .\
BACKGROUND	We investigated whether a simple educational intervention following hospitalization would increase patients ' execution of durable health care proxies .\
METHODS	We studied a consecutive series of patients ( n = 162 ) recently discharged from the acute care medical service of a community hospital where they had been interviewed about advance directives .\
METHODS	The intervention group was randomized to receive an educational brochure and encouragement to execute durable health care proxies .\
METHODS	The primary outcome was the proportion of patients in each group with completed durable health care proxies on file in their primary physicians ' offices .\
RESULTS	Overall , only 20 ( 12.3 % ) of 162 patients had documented proxies , 17 of whom ( 85 % ) were 65 years of age or older , with no difference between the intervention and control groups ( 11 [ 13.3 % ] of 83 vs nine [ 11.4 % ] of 79 , respectively ) .\
RESULTS	Subgroup analysis of elderly patients also revealed no intervention effect .\
RESULTS	Univariate analysis revealed three significant predictors of patients ' proxy completion : patient age , whether patients had discussed directives in hospital with their physicians , and whether patients ' physicians completed proxies for themselves .\
RESULTS	Multiple logistic regression analysis showed that these three variables interact to predict the probability of patients ' executing proxies .\
CONCLUSIONS	Simple educational interventions , like those mandated by the Patient Self-Determination Act , are unlikely to increase patients ' completion of durable healthcare proxies .\
CONCLUSIONS	Multidimensional interventions that target both elderly patients and their personal physicians should be tested in the future .\
CONCLUSIONS	Discussion in hospital about advance directives can be a useful component of such efforts .\
\
###16259547\
OBJECTIVE	Although significant advances have been made in recent years in the treatment of generalized anxiety disorder ( GAD ) , many patients remain symptomatic despite ongoing treatment , underscoring the need for adjunctive new treatments to help improve response .\
METHODS	Forty patients with a primary diagnosis of DSM-IV GAD , who continued to experience GAD symptoms despite current anxiolytic treatment of at least 4 weeks ' duration , as evidenced by Hamilton Rating Scale for Anxiety ( HAM-A ) total score > or = 18 and Clinical Global Impressions-Severity of Illness scale score of moderate or greater , completed a 1-week screening phase and were then randomly assigned to 5 weeks of double-blind adjunctive treatment with placebo or risperidone at flexible doses of 0.5 to 1.5 mg/day .\
METHODS	Patients continued to take their anxiolytics throughout the study .\
METHODS	The study was conducted from June 2001 through March 2003 .\
RESULTS	Adjunctive risperidone was associated with statistically significant improvements in core anxiety symptoms , as demonstrated by greater reductions in HAM-A total scores ( p = .034 ) and HAM-A psychic anxiety factor scores ( p = .047 ) compared with placebo .\
RESULTS	Although change scores on other outcome variables , including response rates , were higher in the risperidone group , differences did not achieve statistical significance .\
CONCLUSIONS	Study findings suggest that risperidone at low doses may represent a useful tool in the management of symptomatic GAD patients .\
\
###20518266\
OBJECTIVE	Polypropylene mesh in the treatment of genital prolapse in women was introduced at the turn of the millennium with the rationale of decreasing surgical invasiveness , reinforcing weak tissues and to possibly complement insufficient surgical techniques .\
OBJECTIVE	Prospective randomized studies comparing traditional and modern operations are lacking .\
METHODS	Prospective multicentre randomized study .\
METHODS	Department of Obstetrics and Gynaecology , The First Faculty of Medicine , Charles University in Prague .\
METHODS	A prospective multicentre trial was approved by the Ministry of Health of the Czech Republic and registered with the FDA planning to recruit 500 patients with vaginal prolapse , 18 years of age and over , undergoing surgery at 5 major urogynaecologic centres .\
METHODS	The patients were divided into three groups according to prolapse predominance .\
METHODS	The surgical techniques used were : anterior and posterior prolift , and randomly allocated total prolift or sacrospinous fixation .\
METHODS	The examination setup included lower urinary tract ultrasound , MRI , POP-Q assessment and QoL questionnaires before surgery and six and 24 month after the surgery .\
CONCLUSIONS	Preliminary analysis of partial data of 225 women showed an acceptable rate of complications and a better success rate in the mesh groups , whereas operation time and blood loss was lower in the classical operation group .\
CONCLUSIONS	Quality of life questionnaires documented that all the methods used have comparably good results .\
CONCLUSIONS	The surgical techniques used are acceptable methods for pelvic organ prolapse repair with low complication rates and excellent impact on the subjective perception of the patient 's quality of life .\
\
###20346136\
BACKGROUND	Poor adherence to antiretroviral treatment has been a public health challenge associated with the treatment of HIV .\
BACKGROUND	Although different adherence-supporting interventions have been reported , their long term feasibility in low income settings remains uncertain .\
BACKGROUND	Thus , there is a need to explore sustainable contextual adherence aids in such settings , and to test these using rigorous scientific designs .\
BACKGROUND	The current ubiquity of mobile phones in many resource-constrained settings , make it a contextually appropriate and relatively low cost means of supporting adherence .\
BACKGROUND	In India , mobile phones have wide usage and acceptability and are potentially feasible tools for enhancing adherence to medications .\
BACKGROUND	This paper presents the study protocol for a trial , to evaluate the influence of mobile phone reminders on adherence to first-line antiretroviral treatment in South India .\
METHODS	600 treatment nave patients eligible for first-line treatment as per the national antiretroviral treatment guidelines will be recruited into the trial at two clinics in South India .\
METHODS	Patients will be randomized into control and intervention arms .\
METHODS	The control arm will receive the standard of care ; the intervention arm will receive the standard of care plus mobile phone reminders .\
METHODS	Each reminder will take the form of an automated call and a picture message .\
METHODS	Reminders will be delivered once a week , at a time chosen by the patient .\
METHODS	Patients will be followed up for 24 months or till the primary outcome i.e. virological failure , is reached , whichever is earlier .\
METHODS	Self-reported adherence is a secondary outcome .\
METHODS	Analysis is by intention-to-treat .\
METHODS	A cost-effectiveness study of the intervention will also be carried out .\
CONCLUSIONS	Stepping up telecommunications technology in resource-limited healthcare settings is a priority of the World Health Organization .\
CONCLUSIONS	The trial will evaluate if the use of mobile phone reminders can influence adherence to first-line antiretrovirals in an Indian context .\
\
###22198243\
OBJECTIVE	To determine whether CA-125 velocity is a statistically significant predictor of ovarian cancer and develop a classification rule to screen for ovarian cancer .\
METHODS	In the ovarian component of the PLCO cancer screening trial , 28,038 women aged 55-74 had at least two CA-125 screening tests .\
METHODS	Ovarian cancer was diagnosed in 72 ( 0.26 % ) women .\
METHODS	A multiple logistic regression model was developed to evaluate CA-125 velocity and other related covariates as predictors of ovarian cancer .\
METHODS	Predictive accuracy was assessed by the concordance index and measures of discrimination and calibration while the fit of the model was assessed by the Hosmer and Lemeshow 's goodness-of-fit ( 2 ) test .\
RESULTS	CA-125 velocity decreased as the number of CA-125 measurements increased but was unaffected by age at baseline screen and family history of ovarian cancer .\
RESULTS	The average velocity ( 19.749 U/ml per month ) of the cancer group was more than 500 times the average velocity ( 0.035 U/ml per month ) of the non-cancer group .\
CONCLUSIONS	Among six covariates used in the model , CA-125 velocity and time intervals between baseline and second to last screening test and between last two screening tests were statistically significant predictors of ovarian cancer .\
CONCLUSIONS	The chance of having ovarian cancer increased as velocity increased , and the chance decreased when the time intervals between baseline and the second to last screening test and between last two screening tests of an individual increased .\
\
###24028358\
OBJECTIVE	To test the effectiveness of a pressure ulcer ( PU ) prevention intervention featuring musical cues to remind all long-term care ( LTC ) staff ( nursing and ancillary ) to help every resident move or reposition every 2 hours .\
METHODS	Twelve-month paired-facility two-arm ( with one-arm crossover ) randomized intervention trial .\
METHODS	Ten midwestern U.S. LTC facilities .\
METHODS	Four treatment facilities received intervention during Months 1 to 12 , four comparison facilities received intervention during Months 7 to 12 , and two pseudo-control facilities received no intervention .\
METHODS	LTC facility residents ( N = 1,928 ) .\
METHODS	All facility staff received in-person education , video , and handouts , and visiting family members received informational pamphlets on PU prevention and an intervention featuring musical cues .\
METHODS	Nurse-led multidisciplinary staff teams presented the cues as prompts for staff and family to reposition residents or remind them to move .\
METHODS	Musical selections ( with and without lyrics ) customized to facility preferences were played daily over the facility intercom or public address system every 2 hours for the 12-hour daytime period .\
METHODS	Primary outcome measure was the frequency of new facility-acquired PUs divided by the total number of facility Minimum Data Set ( MDS ) resident assessments conducted during the study period .\
RESULTS	Odds of a new PU were lower in intervention facilities ( P = .08 ) for MDS 2.0 assessments and were significantly lower ( P = .05 ) for MDS 3.0 .\
RESULTS	Mean odds ratios suggested intervention facility residents were 45 % less likely than comparison facility residents to develop a new PU .\
CONCLUSIONS	Customized musical cues that prompt multidisciplinary staff teams to encourage or enable movement of all residents hold promise for reducing facility-acquired PUs in LTC settings .\
\
###25816542\
BACKGROUND	Bronchopulmonary dysplasia ( BPD ) is one ofthe most significant complications among very-low-birth-weight ( VLBW ) premature infants .\
BACKGROUND	Vitamin A deficiency increases the risk of BPD in VLBWinfants .\
OBJECTIVE	To assess the effect of vitamin A supplementation for prevention of bronchopulmonary dysplasia in VLBW premature Thai infants .\
METHODS	Randomized control trial .\
METHODS	Eighty premature infants weighing < 1,500 g who received mechanical ventilation or oxygen supplementation at 24 hours ofage-admitted to Neonatal units ofSrinagarind Hospital , Khon Kaen University , Khon Kaen , Thailand-were assigned to receive either intramuscular vitaminA 5 , 000 IU3 times/week ( treatment group ) or sham procedure ( control group ) for four weeks .\
METHODS	Serum vitamin A levels were measured before and after administration of the vitamin A.\
RESULTS	The baseline of mean serum vitamin A levels were similar in both groups .\
RESULTS	The mean serum level of vitamin A was significantly higher in the vitamin A supplemented infants than in the control infants on day 7 ( 1.41 + / - 0.48 vs. 0.92 +0.38 pmol / L , p < 0.001 ) , day 14 ( 1.48 + / - 0.90 vs. 0.96 + / - 0.36 micromol/L , p = 0.001 ) and day 28 ( 1.42 + / - 0.63 vs. 0.76 + / - 0.30 micromol/L , p < 0.001 ) after vitamin A supplementation .\
RESULTS	None of the infants in the vitamin A supplemented group , compared to 5 % of the infants in the control group , had vitamin A level < 0.35 micromol/L , ( indicating severe vitamin A deficiency ) at 28 days .\
RESULTS	Fewer of the premature infants in the vitamin A supplemented group required oxygen supplementation at 36 weeks postmenstrual age than in the control group albeit not statistically significant ( 22.5 vs. 35 % relative risk 0.71 ; 95 % CI 0.40 + / - 1.26 ; p = 0.21 ) .\
RESULTS	Supplementation with vitamin A was also associated with a significant reduction in the duration ofintubation ( 10.8 + / - 3.1 days vitamin A supplemented group vs. 26.1 + / - 6.4 days control group , p = 0.03 ) , days on oxygen therapy ( 29.8 + / - 5.1 days vitamin A supplemented group vs. 58.2 + / - 9.1 days control group , p = 0.01 ) and length of hospital stay ( 61.9 + / - 4.2 days vitamin A supplemented group vs. 88.3 + / - 7.2 days control group , p = 0.002 ) .\
CONCLUSIONS	The dose of vitamin A used in this study reduced biochemical evidence of vitamin A deficiency and , without complications , resulted in reducing duration of intubation , days of oxygen therapy , and length of hospital stay in premature infants suffering VLBW\
\
###12095814\
OBJECTIVE	To determine the relation between optical coherence tomography ( OCT ) and optical pachymetry ( OP ) measurements of corneal swelling induced by hypoxia .\
METHODS	Experimental study .\
METHODS	One randomly selected eye of 20 noncontact lens wearers ( 10 males and 10 females , age 35.6 + / - 9.6 years ) was patched during 3 hours of soft contact lens ( SCL ) wear while the contralateral eye acted as control .\
METHODS	Central corneal thickness of both eyes was measured before and after SCL wear using OCT and OP in randomized order .\
RESULTS	Baseline central corneal thickness was 523.6 + / - 33.0 microm ( mean + / - standard deviation [ SD ] ) measured with OCT and 490.6 + / - 25.5 microm with OP .\
RESULTS	Immediately after contact lens removal , corneal thickness measured with OCT increased by 13.8 + / - 2.3 % compared with 12.1 + / - 1.8 % ( paired t test : P < .001 ) measured with OP .\
RESULTS	Thereafter , corneal thickness decreased at the rate of 5.6 % per hour for OCT and 5.4 % per hour for OP .\
RESULTS	The difference in thickness between instruments before lens insertion , which was 33 microm compared with the difference after lens removal ( edematous cornea ) , which ranged from 46 to 41 microm .\
RESULTS	The difference between instruments decreased during the corneal deswelling period after lens removal .\
RESULTS	The correlation coefficient between OCT and OP was 0.914 before lens insertion and 0.932 after lens removal .\
CONCLUSIONS	This study has demonstrated the difference of corneal thickness measured with OCT and OP .\
CONCLUSIONS	Although both instruments are correlated highly in all conditions tested , OCT may overestimate corneal thickness in normal and edematous corneas .\
\
###17683996\
OBJECTIVE	Osteoporosis is common in patients with inflammatory bowel disease ( IBD ) .\
OBJECTIVE	Corticosteroids induce a rapid and important bone loss .\
OBJECTIVE	Clinical trials have shown oral bisphosphonates to effectively prevent steroid-induced bone loss .\
OBJECTIVE	However , patients with IBD have been excluded from most of these studies because of potential digestive adverse events .\
OBJECTIVE	Clodronate is a non-amino-bisphosphonate available in intravenous form without expected digestive ( as oral bisphosphonates ) or proinflammatory ( as amine bisphosphonates ) side effects .\
OBJECTIVE	Our aim was to assess the efficacy of intravenous clodronate in preventing steroid-induced bone loss .\
METHODS	A 12-month , double-blind , randomized , placebo-controlled trial was conducted in IBD patients beginning a steroid therapy .\
METHODS	Sixty-seven patients ( median disease duration , 38 mo ; range , 1-240 mo ) were randomized to receive one infusion per 3 months of either intravenous clodronate ( 900 mg , n = 33 ) or placebo .\
METHODS	All the patients received calcium ( 1 g/day ) and vitamin D ( 800 IU/day ) .\
METHODS	The main outcome was the change in lumbar bone mineral density ( BMD ) between baseline and 1 year .\
METHODS	Secondary outcomes included change in femoral neck BMD and adverse events .\
RESULTS	After 1 year , there was no change in BMD in the clodronate group , neither at the spine ( -0.2 % , not significant ) nor at the femoral neck ( 2.3 % , NS ) .\
RESULTS	In contrast , there was a significant decrease in lumbar spine ( -2.0 % , P = .0018 ) and femoral neck ( -1.7 % , P = .045 ) BMD in the placebo group .\
RESULTS	Tolerance to treatment was good .\
CONCLUSIONS	Intravenous clodronate is effective in the prevention of bone loss induced by steroids in patients with IBD .\
\
###19901102\
OBJECTIVE	Hot flashes are a common problem for which effective and safe treatments are needed .\
OBJECTIVE	The current trial was conducted on the basis of preliminary promising data that pregabalin decreased hot flashes .\
METHODS	A double-blind , placebo-controlled , randomized trial design was used to compare pregabalin at target doses of 75 mg twice daily and 150 mg twice daily with a placebo .\
METHODS	Hot flash frequencies and scores ( frequency times mean severity ) were recorded daily during a baseline week and for six treatment weeks .\
METHODS	The primary end point for this study was the change-from-baseline hot flash score during treatment week 6 between the 150 mg twice daily target pregabalin treatment and placebo .\
METHODS	Nonparametric Wilcoxon rank sum tests , two-sample t tests , and chi ( 2 ) tests were used to compare the primary and secondary hot flash efficacy end points between pregabalin treatments and placebo .\
RESULTS	Hot flash score changes available for 163 patients during the sixth treatment week compared with a baseline week decreased by 50 % , 65 % , and 71 % in the placebo , and target 75 mg twice daily and 150 mg twice daily pregabalin arms , respectively ( P = .009 and P = .007 , comparing respective pregabalin arms to the placebo arm ) .\
RESULTS	While some toxicities were significantly more common in the pregabalin arms , being more evident with the higher dose , pregabalin was generally well tolerated by most patients .\
CONCLUSIONS	Pregabalin decreases hot flashes and is reasonably well tolerated .\
CONCLUSIONS	A target dose of 75 mg twice daily is recommended .\
CONCLUSIONS	Its effects appear to be roughly comparable to what has been reported with gabapentin and with some newer antidepressants .\
\
###10638905\
BACKGROUND	The authors compared the effects of patient-controlled interscalene analgesia ( PCIA ) with ropivacaine 0.2 % and patient-controlled intravenous analgesia ( PCIVA ) with opioids on hemidiaphragmatic excursion and respiratory function after major shoulder surgery .\
METHODS	Thirty-five patients scheduled for elective major shoulder surgery were prospectively randomized to receive either PCIA or PCIVA .\
METHODS	All patients received an interscalene block before surgery .\
METHODS	In the PCIA group , a catheter was introduced between the anterior and middle scalene muscles .\
METHODS	Six hours after the initial block , patients received for 48 h either a continuous infusion of 0.2 % ropivacaine through the interscalene catheter at a rate of 5 ml/h plus a bolus dose of 3 or 4 ml with a lockout time of 20 min ( PCIA group ) or a continuous intravenous infusion of nicomorphine at a rate or 0.5 mg/h plus a bolus dose of 2 or 3 mg with a lockout time of 20 min ( PCIVA group ) .\
METHODS	Hemidiaphragmatic excursion and respiratory function were assessed with the patient in a 45 degrees semirecumbent position the day before the operation and 20 min ( in the operating room ) , 24 h , and 48 h after the initial block by means of ultrasonography and spirometry , respectively .\
METHODS	Pain relief was regularly assessed , side effects were noted , and patient satisfaction was rated 6 h after the end of the study .\
RESULTS	Hemidiaphragmatic excursion was similar in the two groups 20 min after interscalene block .\
RESULTS	Hemidiaphragmatic excursion was increased in the PCIA group on the nonoperated side 24 and 48 h after the interscalene block ( P < 0.05 ) .\
RESULTS	Pulmonary function was similar in the two groups at each time .\
RESULTS	Pain was better controlled in the PCIA group at 12 and 24 h ( P < 0.05 ) .\
RESULTS	The incidence of nausea and vomiting were 5.5 % versus 60 % for the PCIA and PCIVA groups , respectively ( P < 0.05 ) .\
RESULTS	Patient satisfaction was greater in the PCIA group ( P < 0.05 ) .\
CONCLUSIONS	The use of PCIA or PCIVA techniques to provide analgesia after major shoulder surgery is associated with similar effects on respiratory function .\
CONCLUSIONS	In the PCIA group , hemidiaphragmatic excursion showed a significantly greater amplitude 24 and 48 h after the initial block on the nonoperated side .\
CONCLUSIONS	The PCIA technique provided better pain control , a lower incidence of side effects , and a higher degree of patient satisfaction .\
\
###22192087\
BACKGROUND	Shrimp is a frequent cause of severe allergic reactions world-wide .\
BACKGROUND	Due to issues such as cross-reactivity , diagnosis of shrimp allergy is still inaccurate , requiring the need for double-blind , placebo-controlled food challenges ( DBPCFC ) .\
BACKGROUND	A better understanding of the relationship between laboratory findings and clinical reactivity is needed .\
OBJECTIVE	To determine whether sensitization to certain shrimp allergens or recognition of particular IgE epitopes of those allergens are good biomarkers of clinical reactivity to shrimp .\
METHODS	Thirty-seven consecutive patients were selected with clinical histories of shrimp allergy .\
METHODS	Skin prick test , specific IgE determinations , DBPCFC and immunoblot assays to shrimp extract were performed .\
METHODS	IgE binding to synthetic overlapping peptides representing the sequence of the four allergens from the Pacific white shrimp ( Litopenaeus vannamei ) identified to date ( Lit v1 , Lit v2 , Lit v3 and Lit v4 ) was analysed .\
RESULTS	Of 37 ( 46 % ) patients , 17 had a positive challenge to shrimp ( 11 children and 6 adults ) .\
RESULTS	By microarray , patients with positive challenges showed more intense binding to shrimp peptides than those with negative challenges .\
RESULTS	Statistically significant differences in terms of the frequency and intensity of IgE binding to some epitopes were observed between the two groups .\
RESULTS	Diagnostic efficiency was higher for individual epitopes than for proteins .\
RESULTS	Particularly , efficiency was highest for certain Lit v 1 and Lit v 2 epitopes , followed by Lit v 3 and Lit v 4 epitopes .\
CONCLUSIONS	Patients with positive shrimp challenges present in general more intense and diverse epitope recognition to all four shrimp allergens .\
CONCLUSIONS	IgE antibodies to these shrimp epitopes could be used as biomarkers for prediction of clinical reactivity in subjects with sensitization to shrimp .\
CONCLUSIONS	Patients with positive shrimp challenges show more intense sensitization and more diverse epitope recognition .\
CONCLUSIONS	Several IgE-binding shrimp epitopes could be used as biomarkers for predicting clinical reactivity in subjects with sensitization to shrimp .\
\
###11894031\
BACKGROUND	Most lacerations and surgical incisions are closed with sutures or staples .\
BACKGROUND	Octylcyanoacrylate tissue adhesive ( OCA ) was recently approved for use in the United States .\
BACKGROUND	We compared the cosmetic appearance of lacerations and incisions repaired with OCA versus standard wound closure methods ( SWC ) .\
METHODS	A multicenter randomized clinical trial including patients with simple lacerations or surgical incisions was conducted at 10 clinical sites .\
METHODS	Patients were randomly assigned to treatment with OCA or SWC .\
METHODS	Follow-up was performed at 1 week and at 3 months to determine infection rates and cosmetic outcome .\
RESULTS	Eight hundred fourteen patients with 924 wounds ( 383 traumatic lacerations , 235 excisions of skin lesions or scar revisions , 208 minimally invasive surgeries , and 98 general surgical procedures ) were enrolled .\
RESULTS	Groups were similar in baseline characteristics .\
RESULTS	Wound closure with OCA was faster than with SWC ( 2.9 vs 5.2 minutes , P < .001 ) .\
RESULTS	At 1 week infection rates were similar ( OCA , 2.1 % vs SWC , 0.7 % ; P = .09 ) and fewer OCA wounds were erythematous ( 18 % vs 36 % , P < .001 ) .\
RESULTS	There were no differences in wound dehiscence rates ( OCA , 1.6 % vs SWC , 0.9 % ; P = .35 ) .\
RESULTS	At 3 months there was no difference in the percent of wounds with optimal appearance ( OCA , 82 % vs SWC , 83 % ; P = .67 ) .\
CONCLUSIONS	Repair of traumatic lacerations and surgical incisions with OCA is faster than with SWC , and cosmetic outcome is similar at 3 months .\
\
###9823809\
OBJECTIVE	The aim of this study was to assess pain and complication rates after closed hemorrhoidectomy with the use of either scissors or diathermy excision .\
METHODS	Ninety-one consecutive patients were prospectively randomly assigned by use of sealed envelopes to Group A ( diathermy dissection ; n = 44 ) or Group B ( scissors dissection ; n = 47 ) .\
METHODS	The resulting hemorrhoidal pedicle after hemorrhoidal dissection was transfixed and buried under the mucosa , which was closed with 3-0 chromic catgut .\
RESULTS	The median time taken for surgery was ten minutes in both groups .\
RESULTS	The range for Group A was 5 to 25 minutes , and the range for Group B was 5 to 20 minutes .\
RESULTS	There were no statistically significant differences in the pain scores between the two groups for any of the seven postoperative days studied .\
RESULTS	The median number of pethidine injections in Group A was 1 and in Group B was 0 ( P < 0.009 ) .\
RESULTS	The number of oral analgesic tablets used was 8 ( range , 4-10 ) and 14 ( range , 0-10 ) for Groups A and B , respectively ( P < 0.001 ) .\
RESULTS	The number of tubes of topical lignocaine jelly used was 14 ( range , 0-22 ) and 14 ( range , 7-88 ) in Groups A and B , respectively .\
RESULTS	Two patients in each group developed secondary hemorrhage , but no patient had anal stricturing .\
CONCLUSIONS	No excessive complications are seen with closed hemorrhoidectomy , and diathermy seems to require less postoperative analgesic medicine than scissors for closed hemorrhoidectomy except in the first 24 hours .\
\
###16112241\
OBJECTIVE	This study examined the long-term glycaemic control and safety of insulin glargine ( LANTUS ) in patients with Type 2 diabetes .\
METHODS	This < or = 28-month , long-term extension of a multinational , multicentre , open-label 52-week study enrolled patients from the original study to continue taking insulin glargine at bedtime plus previous oral hypoglycaemic agents ( OHAs ) .\
METHODS	Efficacy and safety were assessed by HbA ( 1c ) and adverse events , symptomatic hypoglycaemia and selected clinical and laboratory variables .\
RESULTS	Two hundred and thirty-nine treated patients from the original study entered the extension study and 198 completed the extension study .\
RESULTS	There was a 1.02 % reduction in mean HbA ( 1c ) from baseline of the original study ( 9.44 % ) to endpoint of the extension study ( 8.42 % ) .\
RESULTS	No new or unexpected adverse events were observed with longer term exposure to insulin glargine over a treatment period of < or = 39 months .\
RESULTS	Treatment-emergent adverse events were reported for 152 patients ( 63.6 % ) , four of which ( 1.7 % ) were considered to be possibly treatment-related .\
RESULTS	Mean weight gain observed during the original study was +2.12 kg with an absence of further weight gain at the end of the extension study ( +2.02 kg ) .\
CONCLUSIONS	Long-term insulin glargine treatment plus OHAs provides continued glycaemic control and is well tolerated in patients with Type 2 diabetes .\
CONCLUSIONS	Therefore , insulin glargine appears to be suitable for the long-term management of Type 2 diabetes .\
\
###17322624\
BACKGROUND	A double-blind , randomized , parallel-group , placebo-controlled trial was conducted in patients with paroxysmal atrial fibrillation or flutter ( PAF/PAFL ) experiencing 2 or more episodes of symptomatic PAF/PAFL during a 28-day observation period to determine the dose-response effect and safety of flecainide .\
RESULTS	A total of 143 patients at 30 centers were randomized to receive 25 , 50 , or 100 mg of flecainide or placebo twice daily ( BID ) .\
RESULTS	In 123 patients ( per protocol set ) , those remaining free from PAF/PAFL after the treatment were 3.1 % on placebo , 7.7 % on 25 mg/BID , 9.4 % on 50 mg/BID , and 39.4 % on 100 mg/BID of flecainide .\
RESULTS	As a whole group , a significant linear dose-response ( p < 0.001 ) was observed and a significant difference between placebo and 100 mg/BID was observed ( p < 0.001 ) .\
RESULTS	A similar dose-response between the present study and Caucasian study was demonstrated .\
RESULTS	Although there were 5 patients who needed cardioversion or ablation because of frequent episodes of PAF/PAFL ( 2 in 25 mg/BID , 1 in 50 mg/BID , and 2 in 100 mg/BID of flecainide ) , neither death nor ventricular proarrhythmic event was reported .\
CONCLUSIONS	This study indicated that flecainide exerted a significant dose-dependent effect on the prevention of symptomatic PAF/PAFL recurrence and showed that there was no inter-ethnic difference in the clinical effect of flecainide in patients with PAF/PAFL .\
\
###24139639\
BACKGROUND	Scarce data are available to assess sexual behaviour of individuals using antiretroviral pre-exposure prophylaxis for HIV prevention .\
BACKGROUND	Increased sexual risk taking by individuals using effective HIV prevention strategies , like pre-exposure prophylaxis , could offset the benefits of HIV prevention .\
BACKGROUND	We studied whether the use of pre-exposure prophylaxis in HIV-uninfected men and women in HIV-serodiscordant couples was associated with increased sexual risk behaviour .\
METHODS	We undertook a longitudinal analysis of data from the Partners PrEP Study , a double-blind , randomised , placebo-controlled trial of daily oral pre-exposure prophylaxis among HIV-uninfected partners of heterosexual HIV-serodiscordant couples ( n = 3163 , 18 years of age ) .\
METHODS	Efficacy for HIV prevention was publicly reported in July 2011 , and participants continued monthly follow-up thereafter .\
METHODS	We used regression analyses to compare the frequency of sex-unprotected by a condom-during the 12 months after compared with the 12 months before July 2011 , to assess whether knowledge of pre-exposure prophylaxis efficacy for HIV prevention caused increased sexual risk behaviour .\
RESULTS	We analysed 56132 person-months from 3024 HIV-uninfected individuals ( 64 % male ) .\
RESULTS	The average frequency of unprotected sex with the HIV-infected study partner was 59 per 100 person-months before unmasking versus 53 after unmasking ; we recorded no immediate change ( p = 066 ) or change over time ( p = 025 ) after July , 2011 .\
RESULTS	We identified a significant increase in unprotected sex with outside partners after July , 2011 , but the effect was small ( average of 68 unprotected sex acts per year vs 62 acts in a predicted counterfactual scenario had patients remained masked , p = 004 ) .\
RESULTS	Compared with before July , 2011 , we noted no significant increase in incident sexually transmitted infections or pregnancy after July , 2011 .\
CONCLUSIONS	Pre-exposure prophylaxis , provided as part of a comprehensive prevention package , might not result in substantial changes in risk-taking sexual behaviour by heterosexual couples .\
BACKGROUND	The Bill & Melinda Gates Foundation and the US National Institute of Mental Health .\
\
###21173294\
OBJECTIVE	To compare the influence of 2 volumes of fluid , integrated with goal-directed fluid therapy , on hypovolemia ( a key trigger of tissue hypoperfusion ) and central venous oxygen saturation ( Scvo ) and to assess their relationships with postoperative morbidity .\
METHODS	A prospective , randomized trial of 70 consecutive patients undergoing major abdominal surgery .\
METHODS	Patients were randomly assigned to 6 mL/kg/h of crystalloid ( a restrictive fluid strategy ) or 12 mL/kg/h of crystalloid ( a more conservative fluid strategy ) .\
METHODS	In both groups , a fluid bolus was administered when respiratory variation in peak aortic flow velocity ( PV ) was greater than 13 % .\
METHODS	Data on hypovolemia ( PV > 13 % ) , Scvo , and postoperative complications were recorded for all patients .\
METHODS	Overall incidence of postoperative complications , especially anastomotic leak and sepsis .\
RESULTS	Overall incidence of complications , including postoperative anastomotic leak and sepsis , was higher in the restrictive group than in the conservative group ( all P < .05 ) .\
RESULTS	The number of patients with hypovolemia increased significantly in the restrictive group compared with the conservative group ( P < .001 ) .\
RESULTS	The perioperative mean Scvo ( P = .02 ) and mean minimum Scvo ( P = .04 ) were significantly lower in the restrictive group than in the conservative group .\
RESULTS	Multivariate analysis showed that both hypovolemia and mean minimum Scvo were independently associated with anastomotic leak and sepsis .\
CONCLUSIONS	Excessive fluid restriction increased the level of hypovolemia , leading to reduced Scvo and thereby increased incidence of postoperative complications .\
CONCLUSIONS	Excessive fluid restriction should be applied cautiously in surgical patients .\
BACKGROUND	clinicaltrials.gov Identifier : NCT00852449 .\
\
###15659024\
OBJECTIVE	To evaluate topical application of 1 % sodium carboxymethyl cellulose ( SCMC ) for prevention of postoperative adhesions in a laparoscopic model of uterine trauma in sheep .\
METHODS	Experimental study .\
METHODS	Fourteen non-pregnant ewes .\
METHODS	Ewes were randomly assigned to 1 of 2 groups : control ( saline solution ) or 1 % SCMC treatment .\
METHODS	By left flank laparoscopy , traumatic forceps were used to create serosal trauma ( 1.5 x 5 cm ) and hemorrhage on the left uterine horn .\
METHODS	Either 30 mL saline solution or 30 mL 1 % SCMC was applied topically to the traumatized uterine horn .\
METHODS	Adhesion formation was evaluated by repeat laparoscopy at days 14 and 21 .\
METHODS	Sheep were euthanatized on day 28 for necropsy evaluation of adhesions .\
RESULTS	Five control sheep had adhesions of the uterine horn by day 14 , but only 4 had adhesions at day 21 , and 2 at day 28 .\
RESULTS	Adhesions did not occur in SCMC-treated sheep .\
RESULTS	No adhesions occurred elsewhere in the abdomen .\
CONCLUSIONS	Laparoscopically created uterine trauma is an effective method for induction of uterine adhesions , and laparoscopy is an excellent method for serial evaluation of adhesion formation .\
CONCLUSIONS	SCMC ( 1 % ) was effective at preventing adhesion formation in sheep and no inflammatory response was noted .\
CONCLUSIONS	SCMC ( 1 % ) should be considered for prevention of adhesions in abdominal surgery in sheep .\
\
###23044388\
OBJECTIVE	( 1 ) To chemically characterise Y-TZP surface via X-ray photoelectron spectroscopy ( XPS ) and evaluate the surface energy levels ( SE ) after non-thermal plasma ( NTP ) .\
OBJECTIVE	( 2 ) To test the microtensile bond strength ( MTBS ) of Y-TZP bonded to cured composite disks , after a combination of different surface conditioning methods .\
METHODS	Twenty-four Y-TZP discs ( 13.5 mm4mm ) were obtained from the manufacturer and composite resin ( Z-100 ) discs with similar dimensions were prepared .\
METHODS	All discs were polished to 600 grit and divided into 8 groups ( n = 3 disks each ) , four control ( non-NTP treated ) and four experimental ( NTP treated for 10s ) groups .\
METHODS	All groups received one of the four following treatments prior to cementation with RelyUnicem cement : sand-blasting ( SB ) , a Clearfil ceramic primer ( MDP ) , sand-blasting + MDP ( SBMDP ) , or baseline ( B ) , no treatment .\
METHODS	SE readings and surface roughness parameters were statistically analysed ( ANOVA , Tukey 's , p < 0.05 ) .\
METHODS	Mixed model and paired samples t-tests were used to compare groups on MTBS .\
RESULTS	XPS showed increase in O and decrease in C elements after NTP .\
RESULTS	The polar component increased for BP ( 42.20 mN/m ) and SBP ( 43.77 mN/m ) .\
RESULTS	MTBS values for groups BP ( 21.3 MPa ) , SBP ( 31MPa ) , MDPP ( 30.1 MPa ) and SBMDPP ( 32.3 MPa ) were significantly higher in specimens treated with NTP than their untreated counterparts B ( 9.1 MPa ) , SB ( 14.4 MPa ) , MDP ( 17.8 MPa ) and SBMDP ( 24.1 MPa ) .\
CONCLUSIONS	( 1 ) Increase of O and decrease of C led to higher surface energy levels dictated by the polar component after NTP ; ( 2 ) NTP application increased MTBS values of Y-TZP surfaces .\
\
###18164301\
BACKGROUND	Animal studies have identified hormonal influences on responses to injury and recovery , creating a potential gender effect on outcome .\
BACKGROUND	Progesterone and oestrogen are thought to afford protection in the immediate post-injury period , suggesting females have an advantage , although there has been limited evidence of this in human outcome studies .\
METHODS	This study examined the influence of gender on outcome in 229 adults ( 151 males ) , aged > 17 years , with severe blunt head trauma , initial GCS < 9 and hypotension , recruited into a randomised controlled trial of pre-hospital hypertonic saline resuscitation versus conventional fluid management .\
METHODS	Outcome was measured by survival and Glasgow Outcome Scale-Extended version ( GOS-E ) scores at 6 months post-injury .\
RESULTS	Females recruited into the study had a higher mean age .\
RESULTS	Females were more likely to be injured as passengers and pedestrians and males as drivers or motorcyclists .\
RESULTS	There were no gender differences in GCS or injury severity scores , ICP , cerebral perfusion pressure , gas exchange ( PaO2/FiO2 ratio ) , or duration of mechanical ventilation .\
RESULTS	After controlling for GCS , age and cause of injury , females had a lower rate of survival .\
RESULTS	They also showed a lower rate of good outcome ( GOS-E score > 4 ) at 6 months , but this appeared to reflect the lower rate of initial survival .\
RESULTS	Those females surviving had similar outcomes to males .\
CONCLUSIONS	The study provides no evidence that females fare better than males following severe TBI , suggesting rather that females may fare worse .\
\
###11817908\
BACKGROUND	We hypothesized that nutritional risk factors can be reduced routinely in all patients with coronary artery disease ( CAD ) by modifying general hospital catering into `` antiatherogenic catering '' and providing patients with an education program .\
METHODS	General nutritional rules were applied to transform the standard alimentary regimen of our catering service ( lipids 30 % energy ) into antiatherogenic catering ( lipids 20 % energy ) .\
METHODS	The educational program ( EP ) consisted of a nutritional manual and 4 h/week of lessons .\
METHODS	Eighty male patients ( pts ) with CAD ( 54 + / - 13 years ) , 10 + / - 4 days after an acute coronary event , were randomly allocated by cardiologists to a lipids 30 % energy ( control group = 40 pts ) or to a lipids 20 % energy diet ( previously deposited in our catering service ) + EP ( treatment group = 40 pts ) .\
METHODS	Serum total cholesterol ( T-Chol ) , HDL - ( HDL-Chol ) , LDL - ( LDL-Chol ) , triglycerides ( Trig ) , and body mass index ( BMI ) were determined before and after the 21-day treatment .\
RESULTS	Lipids 20 % energy reduced T-Chol ( P < 0.001 ) , LDL-Chol ( P < 0.001 ) , and Trig ( P < 0.05 ) , while lipids 30 % worsened T-Chol and LDL-Chol .\
RESULTS	The changes in the lipid parameters resulted in significant differences between the two groups .\
CONCLUSIONS	Simple reorganization of hospital catering and an educational program may routinely reduce nutritional risk factors in CAD patients , without individual counseling by the nutrition team .\
\
###15263787\
BACKGROUND	The aim of the present study is to compare a hydrophilic catheter to the standard polyvinyl chloride catheter with regard to bacteriological safety and overall comfort in patients undergoing intravesical immuno - or chemotherapy for bladder cancer .\
METHODS	One hundred patients ( 80 males , 20 females ; median age 65.8 years , range 48-79 years ) eligible for intravesical prophylaxis of superficial bladder cancer recurrences were randomized to receive intravesical therapy using a standard catheter ( group A , n = 50 ) or a hydrophilic catheter ( group B , n = 50 ) .\
METHODS	Urinalysis and urine culture were performed 2 days after catheterization .\
METHODS	Comfort during catheterization was assessed by a 5-point visual analogue scale at the end of the first four instillations .\
RESULTS	Urinary tract infection ( UTI ) was detected in 7.4 % of catheterizations in group A , whereas it occurred in 3.5 % of catheterizations in group B ( p < 0.01 ) .\
RESULTS	Escherichia coli was the most frequent pathogen regardless of the device used .\
RESULTS	At the end of each of the first four instillations , the mean score for discomfort was significantly higher in group A than in group B ( p < 0.001 ) , although catheterization was progressively better tolerated regardless of the device used ( both p < 0.005 ) .\
RESULTS	None of the patients were found to be suffering from orchitis , epididymitis or gross haematuria .\
CONCLUSIONS	Hydrophilic catheters may be used safely and are well tolerated by patients undergoing intravesical immuno - or chemotherapy .\
CONCLUSIONS	The hydrophilic catheter was associated with a significantly lower occurrence of UTI and higher acceptability compared to the standard device .\
CONCLUSIONS	These data should be considered with regard to patient compliance with intravesical therapy .\
\
###9433873\
OBJECTIVE	To assess the efficacy and safety of avocado/soybean unsaponifiables ( ASU ) in the treatment of patients with symptomatic osteoarthritis ( OA ) of the knee or hip , as well as the potential residual effects of ASU after stopping treatment , to determine whether ASU might be a symptomatic slow-acting drug for the treatment of OA .\
METHODS	One hundred sixty-four patients with regular , painful , primary OA of the knee ( n = 114 ) or hip ( n = 50 ) entered a prospective , randomized , double-blind , placebo-controlled , parallel-group , multicenter trial with a 6-month treatment period and a 2-month posttreatment followup .\
METHODS	A 15-day washout period for nonsteroidal antiinflammatory drugs ( NSAIDs ) preceded the study .\
METHODS	Efficacy was judged according to 1 ) Lequesne 's functional index ( LFI ) and 2 ) pain on Huskisson 's visual analog scale ( VAS ; 100-mm scale ) , intake of NSAIDs/analgesics , and overall disability score ( by 100-mm VAS ) .\
RESULTS	Eighty-five patients received ASU ; 79 received placebo .\
RESULTS	One hundred forty-four patients were evaluable at month 6 ( 75 taking ASU ; 69 taking placebo ) .\
RESULTS	The mean + / - SEM LFI score decreased from 9.7 + / - 0.3 to 6.8 + / - 0.4 in the ASU group and from 9.4 + / - 0.3 to 8.9 + / - 0.4 in the placebo group ( P < 0.001 for intergroup difference at month 6 ) .\
RESULTS	Pain decreased from 56.1 + / - 1.6 mm to 35.3 + / - 2.3 in the ASU group and from 56.1 + / - 1.8 mm to 45.7 + / - 2.6 in the placebo group ( P = 0.003 at month 6 ) .\
RESULTS	NSAID consumption was slightly lower in the ASU group .\
RESULTS	Fewer patients in the ASU group required NSAIDs ( 48 % , versus 63 % in the placebo group ; P = 0.054 ) .\
RESULTS	The success rate was 39 % in the ASU group and 18 % in the placebo group .\
RESULTS	Overall functional disability was significantly reduced in the ASU group .\
RESULTS	Improvement appeared more marked in patients with hip OA .\
RESULTS	A residual effect was observed at month 8 .\
RESULTS	Tolerance was good to excellent for most patients .\
CONCLUSIONS	ASU treatment showed significant symptomatic efficacy over placebo in the treatment of OA , acting from month 2 and showing a persistent effect after the end of treatment .\
\
###9200279\
BACKGROUND	The aim of this study was to measure the efficacy of 150-mg ranitidine effervescent tablets compared with 20-mg famotidine wafers in the management of patients presenting to primary care physicians with episodic symptoms of gastro-oesophageal reflux disease ( GORD ) .\
METHODS	The study was of a multicentre , open , randomized , parallel-group design in which 32 Norwegian general practitioners participated .\
METHODS	After a pre-treatment demographic and symptom assessment , eligible patients were allocated to either ranitidine effervescent tablet or famotidine wafer .\
METHODS	Patients were then provided with the study medication , a stopwatch , and a 2-week symptom diary card .\
METHODS	Efficacy was primarily determined by the time to adequate symptom relief for the first symptom episode .\
RESULTS	In total , 377 patients were recruited to the study ; 187 patients received ranitidine effervescent , and 190 received famotidine wafer .\
RESULTS	More than 50 % of the patients had daily GORD symptoms before recruitment .\
RESULTS	Median time to adequate symptom relief was 15 min in the ranitidine group and 18.5 min in the famotidine group ( P = 0.005 ) .\
RESULTS	Adequate symptom relief within 60 min was reported by 165 ( 92 % ) ranitidine patients and 156 ( 84 % ) famotidine patients ( P = 0.02 ) .\
RESULTS	The number of non-responders after 60 min was twice as great in the famotidine group : 30 ( 16 % ) versus 15 ( 8 % ) .\
RESULTS	A greater proportion of patients in the famotidine group liked taking the wafer formulation : 173 ( 94 % ) versus 126 ( 70 % ) ( P = 0.001 ) .\
CONCLUSIONS	There was a statistically significant difference in favour of 150-mg ranitidine effervescent tablets in terms of time to adequate symptom relief and the proportion of patients who achieved adequate symptom relief for the first episode .\
CONCLUSIONS	A greater proportion of patients in the famotidine group liked the type of formulation than in the ranitidine group .\
\
###20216293\
OBJECTIVE	The purpose of this study was to compare the efficacy , collateral damage , and convenience of panretinal photocoagulation for proliferative diabetic retinopathy or severe nonproliferative diabetic retinopathy using a 532-nm solid-state green laser ( GLX ) versus a multispot 532-nm pattern scan laser ( PASCAL ) .\
METHODS	This study was a prospective randomized clinical trial .\
METHODS	Sixty patients with bilaterally symmetrical proliferative diabetic retinopathy or severe nonproliferative diabetic retinopathy participated .\
METHODS	Each patient underwent panretinal photocoagulation : one eye with GLX and the other with PASCAL , two sittings per eye .\
METHODS	Grade 3 burns with a 200-mum spot size were placed with both modalities .\
METHODS	The fluence , pain using the visual analog scale , time , laser spot spread with infrared images , and retinal sensitivity were compared .\
RESULTS	Pattern scan laser and GLX required an average fluence of 40.33 vs 191 J/cm ( 2 ) , respectively .\
RESULTS	Average time required per sitting was 1.43 minutes with PASCAL and 4.53 minutes with GLX .\
RESULTS	Average visual analog scale reading for GLX was 4.6 , whereas that for PASCAL was 0.33 .\
RESULTS	Heidelberg retinal angiography images showed the spot spread as being 430 versus 310 microm at 3 months with GLX and PASCAL .\
RESULTS	The eyes treated with PASCAL showed higher average retinal sensitivity in the central 15 degrees and 15 degrees to 30 degrees zones ( 25.08 and 22.08 dB , respectively ) than the eyes treated with GLX ( 23.16 and 17.14 dB ) , respectively .\
CONCLUSIONS	Pattern scan laser showed lesser collateral damage and similar regression of retinopathy compared with GLX .\
CONCLUSIONS	Pattern scan laser treatment was less time consuming and less painful for the patient compared with GLX .\
\
###22133340\
BACKGROUND	In the last 2 decades , cognitive science and the transportation psychology field have dedicated a lot of effort to designing advanced driver support systems .\
BACKGROUND	Verbal warning systems are increasingly being implemented in modern automobiles in an effort to increase road safety .\
OBJECTIVE	The study presented here investigated the impact of directional speech alert messages on the participants ' speed to judge whether or not naturalistic road scenes depicted a situation of impending danger .\
METHODS	Thirty-eight volunteers performed a computer-based key-press reaction time task .\
RESULTS	Findings indicated that semantic content of verbal warning signals can be used for increasing driving safety and improving hazard detection .\
RESULTS	Furthermore , the classical result regarding signal accuracy is confirmed : directional informative speech messages lead to faster hazard detection compared to drivers who received a high rate of false alarms .\
CONCLUSIONS	Notwithstanding some study limitations ( lack of driver experience and low ecological validity ) , this evidence could provide important information for the specification of future Human-Machine-interaction ( HMI ) design guidelines .\
\
###21964530\
BACKGROUND	Eicosanoids , including PGE-2 and 5-HETE , can increase levels of plasma vascular endothelial growth factor ( VEGF ) .\
BACKGROUND	Overexpression of COX-2 or 5-LOX increases levels of PGE-2 and 5-HETE , respectively .\
BACKGROUND	Elevated levels of VEGF are common in patients with non-small cell lung cancer ( NSCLC ) .\
BACKGROUND	We prospectively measured VEGF in serum collected from patients enrolled in Cancer and Leukemia Group B 30203 , a randomized phase II study of eicosanoid modulation in addition to chemotherapy in patients with advanced NSCLC , to determine whether these levels had prognostic significance and whether they correlated with COX-2 expression and/or responded to inhibition of COX-2 or 5-LOX .\
METHODS	Pre - and post-treatment serum was collected from patients enrolled in CALGB 30203 .\
METHODS	Serum VEGF levels were determined using enzyme-linked immunosorbent assay methodology .\
METHODS	Statistical analyses were performed to determine the correlation between pretreatment serum VEGF levels and time of overall survival .\
METHODS	Pretreatment formalin fixed tissue was stained for 5-LOX and COX-2 by immunohistochemistry .\
RESULTS	The median baseline VEGF level was 502 pg/ml ( range , 55-3453 pg/ml ) .\
RESULTS	Dichotomized serum VEGF levels at median inversely correlated with survival time ( p = 0.008 ) , as did VEGF levels as a continuous variable in multivariate analysis ( p = 0.035 ) .\
RESULTS	VEGF levels were significantly correlated neither with baseline COX-2 expression ( Pearson r = 0.1524 , p = 0.271 ) nor with 5-LOX expression .\
RESULTS	Treatment with COX-2 or 5-LOX inhibitors did not alter the levels .\
CONCLUSIONS	These data indicate that elevated serum VEGF is a negative prognostic variable in NSCLC .\
CONCLUSIONS	VEGF levels are neither correlated with baseline tumor COX-2 expression nor do they respond to COX-2 and/or 5-LOX inhibition plus chemotherapy .\
\
###16989377\
OBJECTIVE	To compare different treatment regimens of chronic suppurative otitis media ( CSOM ) in school children , in regard to their consequence in hearing and discharge from the ear drum perforation .\
METHODS	Randomised controlled trial .\
METHODS	Randomly selected primary schools within Dar es Salaam .\
METHODS	Three hundred and twenty eight children between 5-17 years of age with CSOM in one or both ears .\
RESULTS	Three to four months after the onset of treatment 31 % of group 1 , 54 % of group 2 , and 56 % of group 3 , had dry ears .\
RESULTS	Treatment with dry mopping and boric acid in alcohol ear drops was significantly better than dry mopping alone .\
RESULTS	Adding amoxicillin to the treatment did not improve the end results .\
RESULTS	Hearing test performed before and after treatment showed that the hearing thresholds were the same or better after the treatment .\
RESULTS	The possible risk that boric acid in alcohol ear drops should lead to sensorineural hearing loss has not been confirmed .\
CONCLUSIONS	Based on the above results , the treatment of choice for CSOM in children in Dar es Salaam should be dry mopping and boric acid in spirit ear drops .\
\
###21371993\
BACKGROUND	Patient-shared electronic health records provide opportunities for care outside of office visits .\
BACKGROUND	However , those who might benefit may be unable to or choose not to use these resources , while others might not need them .\
OBJECTIVE	Electronic Communications and Home Blood Pressure Monitoring ( e-BP ) was a randomized trial that demonstrated that Web-based pharmacist care led to improved blood pressure ( BP ) control .\
OBJECTIVE	During recruitment we attempted to contact all patients with hypertension from 10 clinics to determine whether they were eligible and willing to participate .\
OBJECTIVE	We wanted to know whether particular subgroups , particularly those from vulnerable populations , were less willing to participate or unable to because they lacked computer access .\
METHODS	From 2005 to 2006 , we sent invitation letters to and attempted to recruit 9298 patients with hypertension .\
METHODS	Eligibility to participate in the trial included access to a computer and the Internet , an email address , and uncontrolled BP ( BP 140/90 mmHg ) .\
METHODS	Generalized linear models within a modified Poisson regression framework were used to estimate the relative risk ( RR ) of ineligibility due to lack of computer access and of having uncontrolled BP .\
RESULTS	We were able to contact 95.1 % ( 8840/9298 ) of patients .\
RESULTS	Those refusing participation ( 3032/8840 , 34.3 % ) were significantly more likely ( P < .05 ) to be female , be nonwhite , have lower levels of education , and have Medicaid insurance .\
RESULTS	Among patients who answered survey questions , 22.8 % ( 1673/7354 ) did not have computer access .\
RESULTS	Older age , minority race , and lower levels of education were risk factors for lack of computer access , with education as the strongest predictor ( RR 2.63 , 95 % CI 2.30-3 .01 for those with a high school degree compared to a college education ) .\
RESULTS	Among hypertensive patients with computer access who were willing to participate , African American race ( RR 1.22 , 95 % CI 1.06-1 .40 ) , male sex ( RR 1.28 , 95 % CI 1.18-1 .38 ) , and obesity ( RR 1.53 , 95 % CI 1.31-1 .79 ) were risk factors for uncontrolled BP .\
CONCLUSIONS	Older age , lower socioeconomic status , and lower levels of education were associated with decreased access to and willingness to participate in a Web-based intervention to improve hypertension control .\
CONCLUSIONS	Failure to ameliorate this may worsen health care disparities .\
BACKGROUND	Clinicaltrials.gov NCT00158639 ; http://www.clinicaltrials.gov/ct2/show/NCT00158639 ( Archived by WebCite at http://www.webcitation.org/5v1jnHaeo ) .\
\
###20214061\
OBJECTIVE	To observe the effect of balanced muscular tension needling method for improving disabled function of stroke patients with spastic paralysis .\
METHODS	One hundred and six cases with spastic paralysis were randomly divided into an observation group ( 54 cases ) with balanced muscular tension needling method and a control group ( 52 cases ) with routine acupuncture method .\
METHODS	The observation group was treated by acupuncture at the side of extensor and flexor of limbs ; while the control group was treated by acupuncture at Jianyu ( LI 15 ) , Quchi ( LI 11 ) , Waiguan ( TE 5 ) etc. .\
METHODS	And the change of muscle strength , muscle tonus , muscle spasticity and range of joint motion were evaluated hefore and after treatment .\
RESULTS	After 30 days of treatment , the total effective rate of 96.3 % ( 52/54 ) in the observation group was superior to that of 84.6 % ( 44/32 ) in the control group ( P < 0.01 ) .\
RESULTS	After treatment muscle strength , muscle tonus , muscle spasticity and range of joint motion were improved in the two groups , hut the observation group was superior to the control group ( all P < 0.05 ) .\
CONCLUSIONS	Balanced muscular tension needling method can significantly improve the muscle strength , muscle tonus , muscle spasticity and the range of joint motion of the stroke patients with spastic paralysis .\
\
###24291273\
OBJECTIVE	This study aimed to investigate the impact of ticagrelor on adenosine plasma concentration ( APC ) in acute coronary syndrome ( ACS ) patients .\
BACKGROUND	Ticagrelor is a direct-acting P2Y12-adenosine diphosphate receptor blocker .\
BACKGROUND	The clinical benefit of ticagrelor compared with clopidogrel in ACS patients suggests that the drug has non-platelet-directed properties .\
BACKGROUND	Animal andin vitro models suggested that the `` pleiotropic '' properties of ticagrelor may be related to an interaction with adenosine metabolism .\
METHODS	We prospectively randomized 60 ACS patients to receive ticagrelor or clopidogrel .\
METHODS	The APC was measured by liquid chromatography .\
METHODS	To assess the mechanism of APC variation , we measured adenosine deaminase concentration , adenosine uptake by red blood cells , and cyclic adenosine monophosphate production by cells overexpressing adenosine receptors .\
METHODS	The P2Y12-adenosine diphosphate receptor blockade was assessed by the vasodilator-stimulated phosphoprotein index .\
RESULTS	Patients receiving ticagrelor had significantly higher APC than patients receiving clopidogrel ( 1.5 M [ interquartile range : 0.98 to 1.7 M ] vs. 0.68 M [ interquartile range : 0.49 to 0.78 M ] ; p < 0.01 ) .\
RESULTS	The APC was not correlated with vasodilator-stimulated phosphoprotein ( p = 0.16 ) .\
RESULTS	Serum-containing ticagrelor inhibited adenosine uptake by red blood cells compared with clopidogrel or controls ( p < 0.01 for both comparisons ) .\
RESULTS	Adenosine deaminase activity was similar in serum of patients receiving clopidogrel or ticagrelor ( p = 0.1 ) .\
RESULTS	Ticagrelor and clopidogrel had no direct impact on adenosine receptors ( p = not significant ) .\
CONCLUSIONS	Ticagrelor increases APC in ACS patients compared with clopidogrel by inhibiting adenosine uptake by red blood cells .\
\
###24576321\
BACKGROUND	Recent studies involving phototherapy applied prior to exercise have demonstrated positive results regarding the attenuation of muscle fatigue and the expression of biochemical markers associated with recovery .\
BACKGROUND	However , a number of factors remain unknown , such as the ideal dose and application parameters , mechanisms of action and long-term effects on muscle recovery .\
BACKGROUND	The aims of the proposed project are to evaluate the long-term effects of low-level laser therapy on post-exercise musculoskeletal recovery and identify the best dose andapplication power/irradiation time .\
METHODS	A double-blind , randomized , placebo-controlled clinical trial with be conducted .\
METHODS	After fulfilling the eligibility criteria , 28 high-performance athletes will be allocated to four groups of seven volunteers each .\
METHODS	In phase 1 , the laser power will be 200 mW and different doses will be tested : Group A ( 2 J ) , Group B ( 6 J ) , Group C ( 10 J ) and Group D ( 0 J ) .\
METHODS	In phase 2 , the best dose obtained in phase 1 will be used with the same distribution of the volunteers , but with different powers : Group A ( 100 mW ) , Group B ( 200 mW ) , Group C ( 400 mW ) and Group D ( 0 mW ) .\
METHODS	The isokinetic test will be performed based on maximum voluntary contraction prior to the application of the laser and after the eccentric contraction protocol , which will also be performed using the isokinetic dynamometer .\
METHODS	The following variables related to physical performance will be analyzed : peak torque/maximum voluntary contraction , delayed onset muscle soreness ( algometer ) , biochemical markers of muscle damage , inflammation and oxidative stress .\
CONCLUSIONS	Our intention , is to determine optimal laser therapy application parameters capable of slowing down the physiological muscle fatigue process , reducing injuries or micro-injuries in skeletal muscle stemming from physical exertion and accelerating post-exercise muscle recovery .\
CONCLUSIONS	We believe that , unlike drug therapy , LLLT has a biphasic dose-response pattern .\
BACKGROUND	The protocol for this study is registered with the Protocol Registry System , ClinicalTrials.gov identifier NCT01844271 .\
\
###20546197\
OBJECTIVE	Sequential three-step empirical therapy is useful for the management of chronic cough .\
OBJECTIVE	The purpose of this study was to evaluate the efficacy and safety of modified sequential three-step empirical therapy .\
METHODS	Consecutive patients ( n = 240 ) with chronic cough were recruited and randomly assigned to receive modified ( modified group ) or primary ( primary group ) sequential three-step empirical therapy .\
METHODS	The primary end-point was the overall rate of control of chronic cough .\
METHODS	Secondary end-points were the rate of control of chronic cough at each step of therapy , the duration of treatment required , changes in cough symptom score , health-related quality of life and possible adverse effects .\
RESULTS	The study was completed by 106 patients in the modified group and 108 patients in the primary group .\
RESULTS	The overall rate of control of chronic cough was 88.7 % in the modified group and 91.7 % in the primary group ( chi ( 2 ) = 0.54 , P > 0.05 ) .\
RESULTS	There were no obvious differences in the rate of control of cough at each step of therapy , the duration of treatment required , patterns of cough symptom scores or improvements in the health-related quality of life between the modified and primary groups .\
RESULTS	However , the incidence of drowsiness was significantly lower in the modified group than in the primary group ( 11.7 % vs 21.7 % , chi ( 2 ) = 4.32 , P = 0.04 ) .\
CONCLUSIONS	Modified three-step empirical therapy was as efficacious as primary three-step therapy for chronic cough , but was preferable because it had fewer side-effects .\
\
###22442727\
BACKGROUND	Cost consequences analysis was completed from randomized controlled trial ( RCT ) data for the Just-in-time ( JIT ) librarian consultation service in primary care that ran from October 2005 to April 2006 .\
BACKGROUND	The service was aimed at providing answers to clinical questions arising during the clinical encounter while the patient waits .\
BACKGROUND	Cost saving and cost avoidance were also analyzed .\
BACKGROUND	The data comes from eighty-eight primary care providers in the Ottawa area working in Family Health Networks ( FHNs ) and Family Health Groups ( FHGs ) .\
METHODS	We conducted a cost consequences analysis based on data from the JIT project .\
METHODS	We also estimated the potential economic benefit of JIT librarian consultation service to the health care system .\
RESULTS	The results show that the cost per question for the JIT service was $ 38.20 .\
RESULTS	The cost could be as low as $ 5.70 per question for a regular service .\
RESULTS	Nationally , if this service was implemented and if family physicians saw additional patients when the JIT service saved them time , up to 61,100 extra patients could be seen annually .\
RESULTS	A conservative estimate of the cost savings and cost avoidance per question for JIT was $ 11.55 .\
CONCLUSIONS	The cost per question , if the librarian service was used at full capacity , is quite low .\
CONCLUSIONS	Financial savings to the health care system might exceed the cost of the service .\
CONCLUSIONS	Saving physician 's time during their day could potentially lead to better access to family physicians by patients .\
CONCLUSIONS	Implementing a librarian consultation service can happen quickly as the time required to train professional librarians to do this service is short .\
\
###15977693\
BACKGROUND	Anal fissure is a chronic condition characterized by painful defecation and rectal bleeding .\
BACKGROUND	The aim of this study was to compare injection of botulinum toxin versus surgical sphincterotomy for treatment of chronic anal fissure .\
METHODS	In a quasi-experimental trial in a university hospital in Kerman , 50 patients diagnosed with chronic anal fissure received 20 units botulinum toxin ( n = 25 ) or underwent lateral internal sphincterotomy ( n = 25 ) .\
METHODS	All patients were evaluated for pain , bleeding and healing of the fissure from one to six months later by another surgeon .\
METHODS	The data was analyzed by SPSS software with the Mann-Whitney and Fisher 's exact tests .\
RESULTS	One month after treatment , the rate of healing and bleeding in the operation group was better than in the toxin group ( P < 0.05 ) , while pain was equal .\
RESULTS	After two months , none of the patients in either group had complications .\
RESULTS	After six months follow-up , bleeding , pain and healing were better in the operation group .\
CONCLUSIONS	In the clinical evaluation , botulinum toxin is an effective alternative nonsurgical modality for the treatment of chronic anal fissure .\
CONCLUSIONS	We recommend botulinum toxin as the first step in treatment because of the 60 % chance of cure with an easily performed treatment .\
\
###17959585\
BACKGROUND	Different methods and propofol formulations have been used to decrease propofol injection pain , but it remains an unresolved problem .\
BACKGROUND	We aimed to investigate the effect of i.v. acetaminophen pretreatment on the propofol injection pain .\
METHODS	One hundred and fifty ASA I-II patients undergoing general anaesthesia were randomly allocated into three groups .\
METHODS	A 20-gauge catheter was inserted into a superficial radial vein of the left hand , and after the occlusion of venous drainage , Groups I , II , and III were pretreated with 40 mg of lidocaine in saline , 50 mg of i.v. acetaminophen , and 5 ml of saline , respectively .\
METHODS	The occlusion was released after 2 min and one-fourth of the total propofol dose was injected into the vein over a period of 5 s.\
METHODS	During the injection of both pretreatment solution and propofol , patients ' pain was assessed and recorded as 0-3 , corresponding to no , mild , moderate or severe pain , respectively .\
METHODS	Chi2 and Kruskal-Wallis tests were used for the statistical analysis .\
METHODS	For all analyses , differences were considered to be significant at P < 0.05 .\
RESULTS	Patient characteristics were similar among the groups .\
RESULTS	Incidence of pain on injection of propofol in control , i.v. acetaminophen , and lidocaine groups was 64 % , 22 % and 8 % , respectively ( P < 0.05 ) .\
CONCLUSIONS	Pretreatment with i.v. acetaminophen seems to be effective in attenuating pain during i.v. injection of propofol .\
\
###21787499\
BACKGROUND	The objective of this study was to investigate and compare the effect of different light-emitting diode ( LED ) polymerization modes on the bond strength of a methacrylate-based sealer used with Resilon or gutta-percha .\
METHODS	Forty extracted single-rooted teeth were sectioned off below the cementoenamel junction , and the root canals were instrumented by using rotary instruments to ISO # 30/0 .06 taper .\
METHODS	The roots were randomly assigned into 1 of the following groups for root canal obturation : ( 1 ) RealSeal + Resilon and ( 2 ) RealSeal + gutta-percha .\
METHODS	In each group , specimens were further subgrouped according to the LED polymerization mode used to cure RealSeal : ( 1 ) standard ( 20 seconds of maximum intensity ) and ( 2 ) exponential ( 5 seconds of exponential power increase , followed by 15 seconds of maximum intensity ) .\
METHODS	Specimens were stored in 100 % humidity for 1 week at 37 C. Push-out test was performed at a crosshead speed of 1 mm/min on 2-mm-thick root slices obtained from coronal to apical direction .\
METHODS	Multivariate analysis of variance and Tukey tests were used for statistical analysis of the data ( P = .05 ) .\
METHODS	Failure modes were examined under the scanning electron microscope .\
RESULTS	The tested polymerization modes had no significant effect on the bond strength values ( P > .05 ) .\
RESULTS	RealSeal + gutta-percha yielded significantly greater bond strength than RealSeal + Resilon ( P < .05 ) .\
RESULTS	In all groups , the bond strength values decreased significantly from coronal to apical direction ( P < .05 ) .\
RESULTS	Adhesive failure at the sealer-dentin interface was the predominant fracture mode .\
CONCLUSIONS	The exponential photopolymerization mode had no significant advantage over the standard regimen in terms of dentin bond strength .\
\
###15667798\
BACKGROUND	The hemodynamics and oxygenation severely fluctuated during the off-pump coronary artery bypass grafting ( OPCABG ) .\
BACKGROUND	This study aimed at investigating whether or not nicardipine combined with esmolol ( 1:10 ) can maintain systemic and tissue oxygenation during OPCABG .\
METHODS	Twenty patients scheduled for OPCABG were divided ramdomly into Group nicardipine ( N ) and Group nitroglycerine ( X ) respectively combined with esmolol ( E ) ( Dosage ratio : 1 to 10 ) ( Group N + E and Group X + E ) with 10 patients in each group .\
METHODS	The mixed solution of N + E or X + E were titrated to maintain mean arterial blood pressure between 70 and 80 mmHg following anesthesia induction .\
METHODS	The variables of hemodynamics , arterial blood lactate content ( Lac ) and gastric intramucosal partial pressure of carbon dioxide were measured at the following time points : after induction of anesthesia ( T1 ) , pre-revascularization ( T2 ) , grafting of left anterior descending ( T3 ) , right coronary descending ( T4 ) and left coronary circumflexus branches ( T5 ) , post-revascularization ( T6 ) , the end of operation ( T7 ) .\
METHODS	The delivery of oxygen ( DO2 ) , consumption of oxygen ( VO2 ) and gastric intramucosal pH ( pHi ) were calculated .\
RESULTS	The cardiac index ( CI ) in Group N + E was significantly increased ( P < 0.05 ) as compared with T1 during OPCABG , while it was mildly decreased in Group X + E.\
RESULTS	The stroke volumes at T4 , T5 in Group N + E and at T3-T6 in Group X + E were significantly decreased ( P < 0.05 ) .\
RESULTS	The systemic vascular resistance indices in Group N + E were significantly decreased as compared with T1 ( P < 0.05 ) .\
RESULTS	The heart rates in these two Groups were significantly elevated intraoperatively ( P < 0.05 ) .\
RESULTS	The DO2 after the infusion of N + E was significantly increased ( P < 0.05 ) or leveled to T1 , and the Lac were within the normal range .\
RESULTS	But the DO2 in Group X + E was decreased throughout the procedure , reaching significant level at T5 ( P < 0.05 ) , and the Lac was significantly increased beyond normal range ( P < 0.05 ) .\
RESULTS	The pHi in Group N + E was maintained above 7.35 during OPCABG , while it was less than 7.35 from T4 to T7 in Group X + E.\
CONCLUSIONS	Nicardipine combined with esmolol ( 1:10 ) regimen may maintain systemic and tissue oxygenation during OPCABG .\
\
###10527227\
OBJECTIVE	To determine the dose of intrathecal ( IT ) morphine ( along with the intraoperative baseline anesthetic ) that provides significant analgesia yet does not delay extubation in the immediate postoperative period in patients undergoing cardiac surgery and early extubation .\
METHODS	Prospective , randomized , double-blinded , placebo-controlled clinical study .\
METHODS	Single university hospital .\
METHODS	Forty patients undergoing elective coronary artery bypass graft procedure and early extubation .\
METHODS	Twenty patients received 10 microg/kg of IT morphine , and 20 patients received IT placebo .\
METHODS	Perioperative anesthetic management was standardized and included postoperative patient-controlled morphine analgesia .\
RESULTS	Of the patients tracheally extubated during the immediate postoperative period , mean time to extubation was similar in patients who received IT morphine ( 6.8 + / -2.8 h ) or IT placebo ( 6.5 + / -3.2 h ) .\
RESULTS	Four patients who received IT morphine had extubation substantially delayed because of prolonged ventilatory depression .\
RESULTS	There was no difference between groups in postoperative patient-controlled morphine analgesia use .\
CONCLUSIONS	Even when used in conjunction with an intraoperative baseline anesthetic that allows early extubation , IT morphine ( 10 microg/kg ) was unable to provide substantial postoperative analgesia .\
CONCLUSIONS	The risks of using IT morphine in patients undergoing cardiac surgery and early extubation may outweigh the potential benefits .\
\
###11177112\
BACKGROUND	Panic attacks can be induced in persons with panic disorder by inhalation of carbon dioxide .\
BACKGROUND	Hypercapnia also elicits a reflex hyperventilation , which is controlled in part by cholinergic mechanisms .\
BACKGROUND	This study investigated whether the exaggerated response to carbon dioxide in panic disorder ( PD ) can be modulated by antagonists of muscarinic cholinergic receptors .\
METHODS	Twelve patients with PD received biperiden hydrochloride ( a muscarinic antagonist that crosses the blood-brain barrier ) , pirenzepine hydrochloride ( a muscarinic antagonist that does not cross the blood-brain barrier ) , or placebo 2 hours before a 35 % carbon dioxide-65 % oxygen respiratory challenge ( vs air as a placebo ) on 3 separate days , in a double-blind , random crossover design .\
RESULTS	According to patients ' self-ratings of subjective anxiety , inhalation of the carbon dioxide/oxygen mixture provoked a significant and intense response after treatment with pirenzepine and placebo .\
RESULTS	After biperiden treatment , however , hypercapnia elicited a response profile similar to that elicited by air , whereby subjective anxiety remained similar to preinhalation levels .\
CONCLUSIONS	Consistent with the hypothesis of the study , a centrally active muscarinic antagonist can block the response to carbon dioxide commonly observed in subjects with PD .\
\
###15800019\
OBJECTIVE	To evaluate the relationship between activated partial thromboplastin time ( aPTT ) and clinical outcomes in the Global Use of Strategies to Open Occluded Coronary Arteries ( GUSTO-V ) trial comparing standard-dose reteplase to half-dose reteplase and abciximab .\
RESULTS	We analysed data on 11,420 patients receiving unfractionated heparin .\
RESULTS	Peak aPTT levels recorded during the hospitalization were correlated with clinical outcomes .\
RESULTS	Multivariable logistic regression models examined the relationship between peak aPTT levels and ( i ) moderate-to-severe bleeding , ( ii ) intracerebral haemorrhage , ( iii ) reinfarction , and ( iv ) 30-day mortality .\
RESULTS	Non-linear relationships were explored in the models using cubic spline functions .\
RESULTS	Higher rates of significant complications were seen in both groups when aPTT levels were < 50 s or when levels were > 70 s.\
RESULTS	In the combination therapy group , the relationship between aPTT levels and bleeding appeared accentuated .\
RESULTS	Reinfarction rates increased gradually as aPTT levels were > 70 s in both groups , but the relationships were not statistically significant .\
RESULTS	Peak aPTT levels < 50 s were associated with increased 30-day mortality even after multivariable adjustment .\
CONCLUSIONS	Peak aPTT levels < 50 s and > 70 s are associated with worse clinical outcomes in the modern era of fibrinolytic therapy ; these relationships are different in patients receiving standard reteplase vs. combination therapy .\
\
###15811162\
OBJECTIVE	Consumer surveys have identified an over-the-counter ( OTC ) medication that provides complete and long-lasting relief of frequent heartburn as an unmet consumer need .\
OBJECTIVE	The purpose of the two identical studies reported in this paper was to evaluate the safety and effectiveness of 10.3 and 20.6 mg omeprazole magnesium , referred to as Ome-Mg 10 and Ome-Mg 20 , respectively ( equivalent to 10 and 20 mg omeprazole ) for the treatment of frequent heartburn administered as a novel 14-day OTC regimen .\
METHODS	Subjects with frequent heartburn ( heartburn two or more days per week ) took Ome-Mg 10 , Ome-Mg 20 , or placebo for 14 consecutive mornings .\
METHODS	Statistical analyses compared percentage of subjects with no heartburn 24 h after the first dose , after the last dose ( day 14 ) , and percentage of days that subjects were heartburn-free .\
METHODS	Nocturnal heartburn and heartburn rated no more than mild were also assessed .\
RESULTS	Twenty-four hours following the first dose , nearly 50 % of subjects receiving Ome-Mg 20 reported no heartburn , and more than 80 % receiving Ome-Mg 20 had no more than mild heartburn .\
RESULTS	Both doses were significantly more effective than placebo on days 1 and 14 for percentage of subjects heartburn-free for 24 h ( P < or = 0.003 ) , and across all 14 days for percentage of heartburn-free days ( P < 0.001 ) .\
RESULTS	Ome-Mg 20 was significantly more effective than placebo in preventing nocturnal heartburn across all 14 days ( P < 0.001 ) .\
RESULTS	Ome-Mg was well tolerated .\
CONCLUSIONS	These trials demonstrated the safety and effectiveness of a novel 14-day regimen of Ome-Mg 20 in completely preventing heartburn for 24 h establishing it as an excellent self-care treatment for frequent heartburn and supporting the approval of Prilosec OTC .\
\
###11194472\
OBJECTIVE	To assess the effects of tail amputation and treatment with albendazole controlled-release capsule ( CRC ) on the health and productivity of prime lambs .\
METHODS	Field trials on three farms .\
METHODS	About 551 Coopworth-Poll Dorset cross , 588 Border Leicester-Merino-Poll Dorset cross and 575 Corriedale-Poll Dorset cross lambs .\
METHODS	On three farms , lambs with amputated tails were compared with an equal number of lambs with tails left entire .\
METHODS	In both of these groups half the lambs were treated with an albendazole CRC 13 weeks after the start of lambing .\
METHODS	Faecal soiling of the breech and flystrike of the breech were recorded .\
METHODS	Lambs were weighed and body condition scored at each visit and carcase weights and fat score of each lamb at slaughter .\
METHODS	Procedures on the slaughter chain were monitored to determine whether the retention of the tail caused any problems .\
RESULTS	There were no observed benefits of treatment with an albendazole CRC on the farms in the study .\
RESULTS	There was no strong evidence that tail amputation had any long-term effect on the growth rate of lambs or carcase traits .\
RESULTS	No detrimental effects were observed during processing of lambs with long tails in the abattoir .\
RESULTS	Lambs with entire tails had significantly greater mean dag scores than lambs with amputated tails .\
RESULTS	On one farm lambs with entire tails were at about twice the risk of requiring crutching and on another farm were at three times the risk of breech strike compared with lambs with amputated tails .\
CONCLUSIONS	This study provides evidence that amputating the tail is not an absolute requirement to maintain the health and welfare of prime lambs , but leaving the tail of prime lambs entire is likely to increase chemical usage to control flystrike , and to increase the frequency of crutching .\
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###9500624\
BACKGROUND	There has been concern that the increased drug exposure associated with treatment with cyclosporine microemulsion ( CsA-ME ) would lead to an increase in adverse events .\
METHODS	The long-term safety and tolerability of conventional cyclosporine ( CsA ) and CsA-ME were compared in a randomized , multicenter , pharmacoepidemiologic study involving 1097 stable renal transplant patients after 18 months of follow-up .\
RESULTS	No significant difference was seen in change in serum creatinine or calculated creatinine clearance between the two groups .\
RESULTS	Episodes of deterioration in renal function ( change in serum creatinine > or = 20 % ) were categorized with the following results for CsA-ME versus CsA , respectively : acute rejection , 4.5 % vs. 4.5 % ; chronic rejection , 8 % vs. 11 % ; CsA nephrotoxicity , 12 % vs. 7 % ( P = 0.008 ) ; transient changes , 17 % vs. 12 % ; other causes , 4 % vs. 6 % .\
RESULTS	During the first 6 months of the study , a transient increase in the incidence of gastrointestinal and neurological adverse events was seen in the CsA-ME group compared with the CsA group .\
RESULTS	Up to 18 months , patients in the CsA group reported significantly fewer hearing and vestibular disorders , but more cardiovascular problems than those in the CsA-ME group ( P = 0.035 ) .\
CONCLUSIONS	Tolerance to CsA and CsA-ME was similar .\
CONCLUSIONS	Renal function over 18 months was not adversely affected by the increased drug exposure with CsA-ME , although there was a transient increase in nephrotoxicity .\
CONCLUSIONS	The frequency of acute and chronic rejection did not change .\
\
###20368553\
OBJECTIVE	A phase III trial of bevacizumab combined with interferon alfa-2a ( IFN ) showed significant improvements in progression-free survival ( PFS ) in metastatic renal cell carcinoma ( mRCC ) .\
OBJECTIVE	Here , we report overall survival ( OS ) data .\
METHODS	Six hundred forty-nine patients with previously untreated mRCC were randomly assigned to receive bevacizumab ( 10 mg/kg every 2 weeks ) plus IFN ( 9 MIU subcutaneously three times a week ; n = 327 ) or IFN plus placebo ( n = 322 ) in a multicenter , randomized , double-blind , phase III trial .\
METHODS	The primary end point was OS .\
METHODS	Final analysis of the secondary end point ( PFS ) was reported earlier .\
RESULTS	Median OS was 23.3 months with bevacizumab plus IFN and 21.3 months with IFN plus placebo ( unstratified hazard ratio [ HR ] = 0.91 ; 95 % CI , 0.76 to 1.10 ; P = .3360 ; stratified HR = 0.86 ; 95 % CI , 0.72 to 1.04 ; P = .1291 ) .\
RESULTS	Patients ( > 55 % ) in both arms received at least one postprotocol antineoplastic therapy , possibly confounding the OS analysis .\
RESULTS	Patients receiving postprotocol therapy including a tyrosine kinase inhibitor had longer median OS ( bevacizumab plus IFN arm : 38.6 months ; IFN plus placebo arm : 33.6 months ; HR = 0.80 ; 95 % CI , 0.56 to 1.13 ) .\
RESULTS	Tolerability was similar to that reported previously .\
CONCLUSIONS	Bevacizumab plus IFN is active as first-line treatment in patients with mRCC .\
CONCLUSIONS	Most patients with mRCC receive multiple lines of therapy , so considering the overall sequence of therapy when selecting first-line therapy may optimize patient benefit .\
\
###12607672\
BACKGROUND	Fat emboli have been implicated in cerebral dysfunction after cardiopulmonary bypass ( CPB ) .\
BACKGROUND	We sought to identify the source of fat emboli during CPB and devise a technique for their elimination .\
METHODS	Patients undergoing CPB were prospectively randomized to either cardiotomy suction ( n = 7 ) or cell-saving suction device ( n = 6 ) .\
METHODS	Blood was collected at various intervals during CPB , and the fat emboli were identified using oil red O stain .\
METHODS	These emboli were grouped based on their diameter into 10 - to 50-microm and more than 50-microm particles .\
METHODS	The number of fat emboli per slide examined was graded according to the following scale : 1 ( 1 to 10 ) , 2 ( 11 to 20 ) , 3 ( 21 to 30 ) , and 4 ( > 30 emboli ) .\
METHODS	In the second phase of the experiment , a 21-microm filter was attached in series , distal to the cardiotomy reservoir ( n = 6 ) , and fat emboli were quantified .\
RESULTS	Blood from the pericardial well was saturated with fat emboli of both sizes .\
RESULTS	Patients randomized to the cardiotomy suction had a significantly higher number of fat emboli at the end of CPB when compared with those randomized to the cell-saving suction device and dual-filter group .\
RESULTS	Processed blood from both the cardiotomy reservoir and cell-saving device was noted to have an abundance of fat emboli when compared with blood processed through the dual filters .\
CONCLUSIONS	Processed blood from both the cardiotomy reservoir and cell-saving device appear to have an abundance of fat emboli that are completely eliminated by using a 21-microm arterial filter in series with the cardiotomy reservoir .\
CONCLUSIONS	This intervention could potentially reduce neurocognitive dysfunction associated with CPB .\
\
###23876512\
BACKGROUND	Tendon injury is a major cause of lameness and decreased performance in athletic equines .\
BACKGROUND	Various therapies for tendonitis have been described ; however , none of these therapies results in complete tissue regeneration , and the injury recurrence rate is high even after long recovery periods involving rest and physiotherapy .\
METHODS	A lesion was induced with collagenase gel in the superficial digital flexor tendon in the center portion of the metacarpal region of eight equines of mixed breed .\
METHODS	After two weeks , the lesions of the animals in the treated and control groups were treated through the intralesional administration of mesenchymal stem cells derived from adipose tissue ( adMSCs ) suspended in platelet concentrate ( PC ) and with phosphate buffered saline ( PBS ) , respectively .\
METHODS	Serial ultrasound analyses were performed every two weeks .\
METHODS	After 16 weeks of therapy , a biopsy was performed for histopathological , immunohistochemical and gene expression ( type I collagen ( COL1A1 ) , type III collagen ( COL3A1 ) , tenascin-C ( TNC ) , tenomodulin ( TNMD ) , and scleraxis ( SCX ) ) analyses .\
RESULTS	Differences in the ultrasound and histopathological analyses were observed between the groups .\
RESULTS	Improved results were reported in the group treated with adMSCs suspended in PC .\
RESULTS	There was no difference in the gene expression levels observed after the different treatments .\
RESULTS	The main results observed from the histopathological evaluation of the treated group were as follows : a prevention of the progression of the lesion , a greater organization of collagen fibers , and a decreased inflammatory infiltrate .\
RESULTS	A lack of progression of the lesion area and its percentage was observed in the ultrasound image , and increased blood flow was measured by Power Doppler .\
CONCLUSIONS	The use of adMSCs combined with PC for the therapy of experimentally induced tendonitis prevented the progression of the tendon lesion , as observed in the ultrasound examination , and resulted in a greater organization and decreased inflammation , as observed in the histopathological evaluation .\
CONCLUSIONS	These data demonstrate the therapeutic potential of this therapy for the treatment of equine tendonitis .\
\
###17655985\
OBJECTIVE	to evaluate the effect of an immersion bath on pain magnitude during the first stage of labour .\
METHODS	a randomised controlled trial comparing the pain scores of bathing and non-bathing nulliparous women during birth was employed .\
METHODS	the study was conducted at the Normal Birth Center of Amparo Maternal , So Paulo , Brazil .\
METHODS	108 birthing women , with 54 women randomly assigned to each group .\
METHODS	when the birthing women presented at 6-7 cm of cervical dilation , they were placed in an immersion bath for 60 mins .\
METHODS	pain scores , using a behavioural pain scale and a numeric scale , were recorded at two evaluation time points : at 6-7 cm of cervical dilation and 1h after the first pain score evaluation .\
RESULTS	at the first evaluation , on the behavioural scale , the means were 2.1 for both groups ( p = 0.914 ; 95 % confidence intervals ( CI ) 1.9-2 .3 for the control group and 2.0-2 .2 for the experimental group ) .\
RESULTS	On the numeric scale , the means were 8.7 and 8.5 for the control and experimental groups , respectively ( p = 0.235 ; 95 % CI 8.2-9 .2 for the control group and 8.1-8 .9 for the experimental group ) .\
RESULTS	At the second evaluation , the pain score means for both scales were statistically higher in the control group than in the experimental group .\
RESULTS	On the behavioural scale , the scores were 2.4 vs. 1.9 , respectively , for the control and experimental groups ( p < 0.001 ; 95 % CI 2.2-2 .6 for the control group and 1.7-2 .1 for the experimental group ) .\
RESULTS	On the numeric scale , the scores were 9.3 vs. 8.5 , respectively , for the control and experimental groups ( p < 0.05 ; 95 % CI 8.9-9 .7 for the control group and 8.1-8 .9 for the experimental group ) .\
CONCLUSIONS	mean labour pain scores in the control group were significantly higher than those in the experimental group .\
CONCLUSIONS	The present findings suggest that use of an immersion bath is a suitable alternative form of pain relief for women during labour .\
\
###24005134\
OBJECTIVE	The aim of this study was to find out the efficacy of a polyvinyl alcohol ( PVA ) sponge ( Merocel Kennedy ; Medtronic Xomed , Jacksonville , Florida ) sinus pack soaked with levobupivacaine hydrochloride to control postoperative pain and analgesic need following functional endoscopic sinus surgery ( FESS ) .\
METHODS	The study was designed as a prospective , double-blind , randomized , controlled study .\
METHODS	Forty-one patients who underwent FESS were included in the analysis .\
METHODS	Setting A tertiary referral hospital in Turkey .\
METHODS	Patients who underwent FESS were divided into 2 groups .\
METHODS	The PVA sponge sinus packs were soaked with 5 mL of levobupivacaine hydrochloride ( chirocaine 25 mg/10 mL ; Abbott , Nycomed Pharma AS , Elverum , Norway ) in group I and with 5 mL of saline in group II .\
METHODS	Postoperative pain levels were recorded using a visual analog scale ( VAS score , 0-100 ) at 30 minutes and 1 , 2 , 8 , 12 , and 24 hours .\
RESULTS	There were no statistically significant differences between groups regarding age , sex , and American Society of Anesthesiologists status .\
RESULTS	Postoperative VAS values at 30 minutes and 1 , 2 , 8 , 12 , and 24 hours were significantly lower in group I than in group II ( P < .05 ) .\
RESULTS	Supplemental analgesia amount was significantly lower in group I than in group II ( P = .003 ) .\
CONCLUSIONS	Using levobupivacaine-soaked PVA sponge sinus packs after FESS is an effective , easy , and quick method to control postoperative pain , and it improves patient comfort and tolerability .\
\
###9382123\
OBJECTIVE	Screening for prostate cancer with the prostate-specific antigen ( PSA ) remains highly controversial .\
OBJECTIVE	We sought to discern which patient factors predict interest in the PSA and how informed consent impacts these predictors .\
METHODS	In a randomized trial that found that informed consent decreases patient interest in PSA screening , potential predictors of interest were analyzed separately in the uninformed ( n = 102 ) and informed ( n = 103 ) cohorts to examine the effects of the informational intervention .\
RESULTS	Univariate predictors of PSA screening interest ( P < 0.05 ) among uninformed patients included perceived efficacy of screening , perceived seriousness of an abnormal PSA , and willingness to accept treatment risks .\
RESULTS	Among patients who had been informed about PSA screening , univariate predictors included family history of prostate cancer , perceived susceptibility to prostate cancer , age ( inverse association ) , and perceived efficacy , although informed patients rated PSA efficacy significantly lower than uninformed patients ( P < 0.001 ) .\
RESULTS	In multivariate logistic regression modeling for the uninformed cohort , perceived screening efficacy ( P < 0.001 ) , perceived seriousness ( P < 0.05 ) , and willingness to accept treatment risks ( P < 0.05 ) together were significant predictors of PSA screening interest .\
RESULTS	Among informed patients , perceived efficacy ( P < 0.001 ) , perceived susceptibility ( P = 0.01 ) , and younger age ( P = 0.01 ) together predicted interest in screening .\
CONCLUSIONS	In contrast to uninformed patients , patients given information about PSA screening and prostate cancer are more likely to be interested in screening if they have a family history of prostate cancer , are younger , or otherwise consider themselves susceptible to developing prostate cancer .\
CONCLUSIONS	Uninformed patients are more likely to base their screening interest on the perceived seriousness of prostate cancer and on their willingness to accept treatment risks .\
\
###17853767\
OBJECTIVE	To compare clinical therapeutic effects of combined ear point blood-letting therapy , oral administration of medicine and external application of medicine on acne vulgaris .\
METHODS	The patients of acne vulgaris were randomly divided into a treatment group and a control group .\
METHODS	The treatment group were treated with ear point blood-letting combined with cupping at Back-shu points ; and the control group with oral administration of Tetracycline and external application of Cuochuangping Ointment .\
RESULTS	After treatment of 1approximately 3 courses , the cured rate ( 50.0 % ) and the total effective rate ( 92.9 % ) in the treatment group were significantly higher than 17.6 % and 76.5 % in the control group with a very significant difference between the two groups ( P < 0.01 ) ; a half year later , the recurrence rate or the deteriorative rate in the treatment group was significantly lower than that in the control group ( P < 0.01 ) .\
CONCLUSIONS	The therapeutic effect of ear point blood-letting combined with cupping at Back-shu points is significantly better than that of oral administration of Tetracycline and external application of Cuochuangping Ointment .\
\
###22704868\
BACKGROUND	Angina and intermittent claudication impair function and mobility and reduce health-related quality of life .\
BACKGROUND	Both symptoms have similar etiology , yet the physical and psychological impacts of these symptoms are rarely studied in community-based cohorts or in individuals with isolated symptoms .\
METHODS	The 2003 Scottish Health Survey was a cross-sectional survey which enrolled a random sample of individuals aged 16-95 years living in Scotland .\
METHODS	The Rose Angina Questionnaire , the Edinburgh Claudication Questionnaire , the Short Form-12 ( SF-12 ) and the General Health Questionnaire were completed .\
METHODS	Self-assessed general health was reported .\
METHODS	Survey results were linked to national death records and mortality at five years was calculated .\
METHODS	Subjects with isolated angina or intermittent claudication and neither symptom were compared ( 22 participants with both symptoms were excluded ) ; 7403 participants ( aged 16 years ) were included .\
RESULTS	Participants with angina ( n = 205 ; 60 15 years ; 45 % male ) rated their general health worse and were more likely to have a potential mental-health problem than those with intermittent claudication ( n = 173 ; 61 15 years ; 41 % male ) .\
RESULTS	Mean ( standard deviation ) physical and mental component scores on the SF-12 were higher for participants with intermittent claudication relative to those with angina ( physical component score : 42.3 ( 10.6 ) vs. 35.0 ( 11.7 ) , p < 0.001 ; mental component score : 52.3 ( 8.5 ) vs. 46.5 ( 11.7 ) , p = 0.001 ) .\
RESULTS	There was an observed absolute difference in five-year mortality of 4.8 % ( angina 12.3 % , 95 % CI 8.5-17 .6 ; intermittent claudication 7.5 % , 95 % CI 4.4-12 .6 ) although not statistically significant ( p = 0.16 ) .\
CONCLUSIONS	Both intermittent claudication and angina adversely impact general and mental health and survival , even in a relatively young , community-based cohort .\
\
###16536764\
OBJECTIVE	To evaluate the effect of alfuzosin 10 mg once daily administered for 2 years on progression events in men with lower urinary tract symptoms/benign prostatic hyperplasia ( LUTS/BPH ) .\
METHODS	In all , 1522 men at risk of having progression events from LUTS/BPH were randomized to receive alfuzosin 10 mg once daily ( 759 ) or placebo ( 763 ) for 2 years .\
METHODS	Endpoints assessed were the occurrence of a first episode of acute urinary retention ( AUR ; primary ) and the need for BPH-related surgery .\
METHODS	Post hoc analyses included a deterioration in the International Prostate Symptom Score ( IPSS ) of > or = 4 points and overall clinical progression of BPH ( occurrence of AUR and/or surgery and/or symptom deterioration ) .\
RESULTS	Over 2 years , symptom deterioration was the most common progression event ( 14.3 % ) , followed by BPH-related surgery ( 5.8 % ) and AUR ( 2.0 % ) .\
RESULTS	Alfuzosin did not reduce the risk of AUR ( alfuzosin 2.1 % vs placebo 1.8 % , P = 0.82 ) but tended to reduce the risk of surgery ( 5.1 % vs 6.5 % , P = 0.18 ) ; the reduction in risk ( RR ) and 95 % confidence interval with alfuzosin was 22 ( -18 to 48 ) % ; and significantly reduced the risk of symptom deterioration ( 11.7 % vs 16.8 % ; P = 0.0013 ) ; the RR was 30 ( 10-46 ) % .\
RESULTS	The overall clinical progression of BPH was significantly lower with alfuzosin than with placebo ( 16.3 % vs 22.1 % , P < 0.001 ) ; RR 26 ( 9-40 ) % .\
RESULTS	Alfuzosin also significantly improved the IPSS ( P = 0.017 ) , quality of life ( P < 0.001 ) and peak flow rate ( P = 0.001 ) compared with placebo .\
RESULTS	Baseline levels of prostate-specific antigen ( PSA ) predicted both AUR and BPH-related surgery events , while the baseline postvoid residual urine volume predicted symptom deterioration .\
RESULTS	The incidence of adverse events with alfuzosin was comparable to that with placebo .\
CONCLUSIONS	Alfuzosin 10 mg once daily prevents the overall clinical progression of BPH , defined by the occurrence of a deterioration in IPSS of > or = 4 points and/or AUR and/or BPH-related surgery , but does not reduce the primary occurrence of AUR .\
CONCLUSIONS	Alfuzosin significantly improves LUTS and quality of life over 2 years , and is well tolerated .\
\
###15593011\
BACKGROUND	Malaria during pregnancy contributes to maternal anemia and low birth weight .\
BACKGROUND	In East Africa , several studies have demonstrated that intermittent preventive treatment ( IPT ) with sulfadoxine-pyrimethamine ( SP ) is more efficacious than weekly chloroquine ( CQ ) chemoprophylaxis in preventing these adverse consequences .\
BACKGROUND	To our knowledge , there are no published trials evaluating IPT in West Africa .\
METHODS	We undertook a randomized controlled trial of weekly CQ chemoprophylaxis , 2-dose IPT with CQ , and 2-dose IPT with SP ; 1163 women were enrolled .\
RESULTS	In multivariate analyses , when compared with weekly CQ , IPT/SP was associated with a reduction in third-trimester anemia ( adjusted odds ratio [ AOR ] , 0.49 ; P < .001 ) , placental parasitemia ( AOR , 0.69 ; P = .04 ) , and low birth weight ( < 2500 g ) ( AOR , 0.69 ; P = .04 ) .\
RESULTS	The prevalence of placental infection remained unexpectedly high , even in the IPT/SP group ( 24.5 % ) , possibly because of the intensity of seasonal transmission .\
RESULTS	There were no significant differences in stillbirths , spontaneous abortions , or neonatal deaths among the 3 groups .\
CONCLUSIONS	In Mali , IPT with SP appears more efficacious than weekly chloroquine chemoprophylaxis in preventing malaria during pregnancy .\
CONCLUSIONS	These data support World Health Organization recommendations to administer at least 2 doses of IPT during pregnancy .\
CONCLUSIONS	In intensely seasonal transmission settings in Mali , > 2 doses may be required to prevent placental reinfection prior to delivery .\
\
###11213882\
OBJECTIVE	Insulin detemir ( NN304 ) is a soluble basal insulin analog developed to cover basal insulin requirements .\
OBJECTIVE	This trial aimed to compare the blood glucose-lowering effect of insulin detemir with that of NPH insulin ( NPH ) and to evaluate the two treatments with regard to intrasubject variation of fasting blood glucose , incidence of hypoglycemia , dose requirements , and safety .\
METHODS	This multicenter open randomized crossover trial in 59 type 1 diabetic subjects comprised a 2-week run-in period on a basal-bolus regimen with NPH insulin once daily , followed by two 6-week periods of optimized basal-bolus therapy with either once-daily insulin detemir or NPH insulin .\
RESULTS	The area under the curve , in the time interval 23:00 -8:00 , derived from 24-h serum glucose profiles , was not statistically significantly different for the two treatment periods ( insulin detemir : NPH ratio 89.2:83.5 , P = 0.59 ) .\
RESULTS	The intrasubject variation in fasting blood glucose during the last 4 days of treatment was lower for insulin detemir compared with NPH ( P < 0.001 ) .\
RESULTS	Mean dose requirements of insulin detemir were 2.35 times higher ( 95 % CI 2.22-2 .48 ) compared with NPH .\
RESULTS	During the last week of treatment , fewer subjects experienced hypoglycemic episodes on insulin detemir ( 60 % ) compared with NPH treatment ( 77 % ) ( P = 0.049 ) .\
CONCLUSIONS	Insulin detemir was as effective as NPH in maintaining glycemic control when administered at a higher molar dose .\
CONCLUSIONS	The results indicate that insulin detemir may provide more predictable fasting blood glucose with lower intrasubject variation and reduced risk of hypoglycemia compared with NPH .\
\
###22078433\
OBJECTIVE	The purpose of this study was to evaluate the safety and effectiveness of the Edwards SAPIEN transcatheter heart valve ( Edwards Lifesciences LLC , Irvine , California ) in the pulmonary position in patients with moderate to severe pulmonary regurgitation with or without stenosis .\
BACKGROUND	Transcatheter pulmonary valve replacement is evolving , but to date , experience has been limited to the Melody valve ( Medtronic Inc. , Minneapolis , Minnesota ) .\
METHODS	Eligible patients with dysfunctional right ventricle-to-pulmonary artery conduits were screened if body weight was 35 kg and the in situ conduit diameter was 16 mm and 24 mm .\
METHODS	Standardized implantation and follow-up protocols were used .\
RESULTS	Thirty-six patients from 4 centers were recruited between April 2008 and May 2010 .\
RESULTS	Mean body weight was 73.4 22.9 kg .\
RESULTS	Successful valve deployment was achieved in 33 of 34 attempts ( 97.1 % ) .\
RESULTS	Valve migration occurred in 3 patients , with 2 requiring surgical retrieval ; however , 1 patient underwent successful perventricular valve implantation .\
RESULTS	Further intraprocedure complications included pulmonary hemorrhage ( n = 2 ) , ventricular fibrillation ( n = 1 ) , and stent migration ( n = 1 ) .\
RESULTS	Pullback gradient across the conduit decreased from 26.8 18.4 mm Hg to 11.7 8.0 mm Hg ( p < 0.001 ) .\
RESULTS	The right ventricular/aortic pressure ratio decreased from 0.6 0.2 to 0.4 0.1 ( p < 0.001 ) .\
RESULTS	Peak Doppler gradient across the right ventricular outflow tract decreased from 41.9 27.9 mm Hg to 19.1 13.3 mm Hg ( p < 0.001 ) .\
RESULTS	At 6-month follow-up , all patients were alive .\
RESULTS	The number of patients with New York Heart Association functional class I increased from 5 at baseline to 27 at follow-up .\
RESULTS	Pulmonary regurgitation was 2 + in 97 % of patients .\
RESULTS	Freedom from reintervention was 97 % with 1 patient undergoing elective placement of a second valve due to conduit-induced distortion of the initial implant .\
CONCLUSIONS	Transcatheter pulmonary valve replacement using the Edwards SAPIEN transcatheter heart valve is safe and effective in patients with dysfunctional right ventricle-to-pulmonary artery conduits .\
\
###24720924\
OBJECTIVE	The objective of this study was to determine the impact of nonfatal cardiovascular ( CV ) events on changes in health-related quality of life ( HRQL ) .\
BACKGROUND	There is limited understanding of the impact of nonfatal CV events on long-term changes in HRQL in survivors ofmyocardial infarction ( MI ) .\
METHODS	The VALIANT ( Valsartan In Acute Myocardial Infarction ) trial enrolled 14,703 patients post-MI complicated by Killip class II or higher ( scale measuring heart failure severity post-MI ranging from class I to IV ) and/or reduced ejection fraction .\
METHODS	The HRQL substudy included 2,556 ( 17.4 % ) patients who completed the EQ-5D with 5 questions , with responses mapped to utility weight on a scale of 0 to 1 and a visual analog scale ( VAS ) ranging from 0 ( worst ) to 100 ( best ) imaginable health state .\
METHODS	EQ-5D was administered at baseline and 6 , 12 , 20 , and 24 months .\
METHODS	The trajectory of EQ-5D scores was developed by using linear mixed effects regression models with calculation of deviation from this trajectory after nonfatal CV events .\
METHODS	Patients who died before the next EQ-5D assessment were excluded .\
RESULTS	Over a 2-year period , 597 patients experienced a nonfatal CV event and survived to have another EQ-5D assessment .\
RESULTS	Their baseline EQ-5D scores were lower than patients without a subsequent nonfatal CV event ( VAS 61.0 19 vs 68.2 18 [ p < 0.001 ] and US-based utility score 0.76 0.22 vs 0.83 0.17 [ p < 0.001 ] ) .\
RESULTS	These patients with CVevents experienced a trajectory-adjusted 6.6 point decrease ( p < 0.001 ) in VAS scores and a 0.07 decrease ( p < 0.001 ) in utility score after the nonfatal CV event .\
CONCLUSIONS	MI survivors suffering a CV event experienced significantly worse HRQL than their previous trajectory , suggesting that generic instruments can be responsive to nonfatal events .\
CONCLUSIONS	Reduction in nonfatal CV events may affect longitudinal changes in HRQL .\
\
###24856460\
OBJECTIVE	The aim was to develop a method for the purpose of localizing epilepsy related hemodynamic foci for patients suffering intractable focal epilepsy using task-free fMRI alone .\
METHODS	We studied three groups of subjects : patients with intractable focal epilepsy , healthy volunteers performing motor tasks , and healthy volunteers in resting state .\
METHODS	We performed spatial independent component analysis ( ICA ) on the fMRI alone data and developed a set of IC selection criteria to identify epilepsy related ICs .\
METHODS	The method was then tested in the two healthy groups .\
RESULTS	In seven out of the nine surgery patients , identified ICs were concordant with surgical resection .\
RESULTS	Our results were also consistent with presurgical evaluation of the remaining one patient without surgery and may explain why she was not suitable for resection treatment .\
RESULTS	In the motor task study of ten healthy subjects , our method revealed components with concordant spatial and temporal features as expected from the unilateral motor tasks .\
RESULTS	In the resting state study of seven healthy subjects , the method successfully rejected all components in four out of seven subjects as non-epilepsy related components .\
CONCLUSIONS	These results suggest the lateralization and localization value of fMRI alone in presurgical evaluation for patients with intractable unilateral focal epilepsy .\
CONCLUSIONS	The proposed method is noninvasive in nature and easy to implement .\
CONCLUSIONS	It has the potential to be incorporated in current presurgical workup for treating intractable focal epilepsy patients .\
\
###23327034\
BACKGROUND	The purpose of this study is to investigate the suitability of dexmedetomidine as a helpful sedative agent in direct laryngoscopic biopsy ( DLB ) , under total intravenous anesthesia ( TIVA ) .\
METHODS	In this double blind randomised study , patients were allocated to receive dexmedetomidine 0.5 microg/kg ( group D , n = 20 ) or saline placebo ( group P , n = 20 ) intravenously .\
METHODS	Forty ASA I-III patients were infused propofol and administered rocuronium bromur .\
METHODS	They were intubated and performed biopsy .\
METHODS	Aldrete scores , intraoperative propofol and postoperative analgesic requirements , satisfaction scores , recovery time , Ramsay sedation scale ( RSS ) , haemodynamic changes and side effects were recorded .\
RESULTS	Postoperative analgesic requirement in group D was significantly lower and satisfaction scores and RSS were significantly higher than in group P. Additionally , MAP ( mean arterial blood pressure ) significantly decreased at post-extubation time in group D.\
CONCLUSIONS	The premedication with a single dose of dexmedetomidine decreases intraoperative propofol and postoperative analgesic requirements , increases the postoperative satisfaction and RSS considerably in patients undergoing DLB under TIVA .\
\
###9845852\
OBJECTIVE	To evaluate the effect of diet and drug intervention separately and combined in the treatment of primary hypercholesterolemia .\
METHODS	The study was conducted as a randomized , placebo-controlled factorial trial , double-blinded for drug intervention .\
METHODS	Subjects were recruited from a population-based cholesterol screening programme .\
METHODS	215 middle-aged men with primary hypercholesterolemia , free from cardiovascular disease .\
METHODS	Subjects were randomized to one of four intervention groups : ( 1 ) placebo and US National Cholesterol Education Program step 1 diet ; ( 2 ) placebo and step 2 diet ; ( 3 ) pravastatin 20 mg day-1 and step 1 diet ; or ( 4 ) pravastatin 20 mg day-1 and step 2 diet .\
METHODS	The intervention period was 6 months .\
METHODS	Efficacy measurements included : serum total cholesterol , HDL cholesterol , triglycerides , apolipoproteins A1 and B. LDL cholesterol was calculated .\
METHODS	For safety , values of ALAT , ASAT and CK were measured .\
RESULTS	In the group receiving the step 1 diet only , lipid values were stable during the study period .\
RESULTS	In the placebo group on the step 2 diet , total cholesterol decreased by 6.3 % ( 0.47 mmol L-1 ( 95 % CI : 0.28 , 0.67 ) ) during 6 months .\
RESULTS	In the group receiving both pravastatin and the step 1 diet , there was a mean reduction in serum total cholesterol of 19.4 % ( 1.46 mmol L-1 ( 95 % CI : 1.20 , 1.72 ) ) .\
RESULTS	In the group treated with pravastatin and the step 2 diet , the 6 months of data show a reduction of 20.7 % ( 1.55 mmol L-1 ( 95 % CI : 1.30 , 1.80 ) ) .\
CONCLUSIONS	If drug therapy with a HMG-CoA reductase inhibitor is considered necessary , a step 2 diet has no additional lipid-lowering effect compared with a step 1 diet in men with primary hypercholesterolaemia .\
CONCLUSIONS	However , favourable ` side-effects ' of a lipid-lowering diet , such as weight loss and lowering of blood pressure , may still warrant a low-fat diet in these cases .\
\
###20466589\
OBJECTIVE	This study evaluated the dose-related efficacy and safety of pregabalin in patients with idiopathic restless legs syndrome ( RLS ) .\
METHODS	This six-arm , double-blind , placebo-controlled , dose-response study randomized patients ( N = 137 ) with moderate-to-severe idiopathic RLS in an equal ratio to placebo or pregabalin 50 , 100 , 150 , 300 , or 450 mg/day .\
METHODS	The dose-response was characterized using an exponential decay model , which estimates the maximal effect ( E ( max ) ) for the primary endpoint , the change in the International Restless Legs Study Group Rating Scale ( IRLS ) total score from baseline to week 6 of treatment .\
METHODS	Secondary outcomes included Clinical Global Impressions-Improvement Scale ( CGI-I ) responders , sleep assessments , and safety .\
RESULTS	The separation of treatment effect between placebo and pregabalin began to emerge starting at week 1 which continued and increased through week 6 for all dose groups .\
RESULTS	The IRLS total score for pregabalin was dose dependent and well characterized for change from baseline at week 6 .\
RESULTS	The model estimated 50 % ( ED ( 50 ) ) and 90 % ( ED ( 90 ) ) of the maximal effect in reducing RLS symptoms that occurred at pregabalin doses of 37.3 and 123.9 mg/day , respectively .\
RESULTS	A higher proportion of CGI-I responders was observed at the two highest doses of pregabalin ( 300 and 450 mg/day ) versus placebo .\
RESULTS	Dizziness and somnolence were the most common adverse events and appeared to be dose-related .\
CONCLUSIONS	In this 6-week phase 2b study , pregabalin reduced RLS symptoms in patients with moderate-to-severe idiopathic RLS .\
CONCLUSIONS	The symptom reduction at week 6 was dose-dependent with 123.9 mg/day providing 90 % efficacy .\
CONCLUSIONS	Pregabalin was safe and well tolerated across the entire dosing range .\
\
###17437826\
OBJECTIVE	We assessed the relationships among severity measures of urinary incontinence in women with stress predominant symptoms enrolled in a randomized clinical trial comparing 2 surgical techniques ( Burch colposuspension vs pubovaginal sling ) for stress urinary incontinence .\
METHODS	A total of 655 women underwent a standardized preoperative assessment that included the Medical , Epidemiological and Social Aspects of Aging questionnaire , Urogenital Distress Inventory , Incontinence Impact Questionnaire , 3-day voiding diary , 24-hour pad test , a supine empty bladder stress test and Valsalva leak point pressure measurements .\
METHODS	Correlations were estimated using Spearman correlation coefficients and 95 % confidence intervals .\
METHODS	T tests at alpha = 0.05 were conducted to compare the distributions of the continuous severity measure between patients with positive and negative supine empty bladder stress test .\
RESULTS	Baseline mean scores on Medical , Epidemiological and Social Aspects of Aging , Urogenital Distress Inventory and Incontinence Impact Questionnaire were 25.8 , 151 and 171 , respectively .\
RESULTS	Mean incontinence episode frequency and pad weight were 3.2 per day and 43.5 gm , respectively .\
RESULTS	Supine empty bladder stress test was positive in 218 patients , and 428 patients had valid Valsalva leak point pressure measurements with a mean Valsalva leak point pressure of 80 cm H ( 2 ) O. Weak to moderate correlations were observed between Medical , Epidemiological and Social Aspects of Aging , incontinence episode frequency , pad weight , Incontinence Impact Questionnaire and Urogenital Distress Inventory .\
RESULTS	On the other hand , Valsalva leak point pressure correlated poorly with all variables measured .\
RESULTS	The sensitivity and specificity of the supine empty bladder stress test to predict intrinsic sphincter dysfunction were 49 % and 60 % , respectively .\
CONCLUSIONS	Urinary incontinence severity measures correlate moderately with each other at best .\
CONCLUSIONS	While Medical , Epidemiological and Social Aspects of Aging demonstrated stronger correlations with the other measures of severity and quality of life , Valsalva leak point pressure did not .\
CONCLUSIONS	Supine empty bladder stress test did not demonstrate a clinically significant association among severity measures .\
\
###23283255\
BACKGROUND	Research suggests that young children experience an increased incidence and severity of discomfort during propofol infusion .\
BACKGROUND	Evaluations of varied interventions to reduce or eliminate this discomfort with adult subjects suggest that premedication with intravenously administered lidocaine ( 0.5 mg/kg ) offers the best overall effectiveness .\
OBJECTIVE	Because this regimen 's efficacy in a pediatric population is undocumented , we conducted a randomized , double-blind , placebo-controlled study to determine the effectiveness of intravenous lidocaine pretreatment to alleviate pain in pediatric subjects before propofol infusion .\
METHODS	Subjects ( aged 2-7 years ) scheduled for painless diagnostic procedures received either a saline placebo or 1 of 2 lidocaine doses before administering propofol .\
METHODS	To capture the patient 's baseline behavioral state , a trained observer administered the validated face , legs , activity , cry , consolability pain assessment scale before propofol infusion .\
METHODS	During deep sedation induction , the sedating physician , a trained research assistant , and the patient 's parent documented maximum distress using a 100-mm visual analog scale ( VAS ) .\
RESULTS	Ninety-one subjects participated .\
RESULTS	We found no difference in VAS pain scores between groups pretreated with lidocaine 0.25 mg/kg , lidocaine 0.5 mg/kg , and placebo .\
RESULTS	Statistical analysis also found no interrater differences between parents , physician , or observer VAS scores .\
CONCLUSIONS	Our data do not support using lidocaine pretreatment to alleviate pain/discomfort in pediatric patients during propofol infusion .\
\
###10519718\
OBJECTIVE	To study the effect of a standardised training programme focusing on maintenance of fat free mass during weight reduction by energy reduction in obese children .\
METHODS	Randomised trial of physical training programme and dietary advice ( group A ) versus dietary advice alone ( group B ) .\
METHODS	Thirty obese children and adolescents ( 14 group A , 16 group B ) participated in the 12 week long programme ; 20 children ( 10 group A , 10 group B ) were also reassessed after one year .\
METHODS	Fat free mass was estimated from the resistance index , obtained by bioelectrical impedance analysis at baseline , after four , eight , and 12 weeks in all subjects , and after one year in 20 subjects .\
RESULTS	The mean ( SD ) change in fat free mass was significantly different between the two groups after 12 weeks ( group A , 2.68 ( 3.74 ) kg ; group B , 0.43 ( 1.65 ) kg ) .\
RESULTS	The change in body weight after one year was inversely correlated with the change in fat free mass after 12 weeks ( r = -0.44 ) , as assessed in the 20 subjects .\
CONCLUSIONS	A standardised training programme as used in this study can prevent reduction in fat free mass during weight loss in obese children .\
CONCLUSIONS	Reduction in fat free mass during weight reduction might be a risk factor for regain of weight .\
\
###15641055\
OBJECTIVE	To explore the impact of an early treatment response on maintenance of work capacity in patients with early , active rheumatoid arthritis ( RA ) .\
METHODS	In the Finnish Rheumatoid Arthritis Combination Therapy trial , 195 patients with recent-onset RA were randomized to receive either a combination of disease-modifying antirheumatic drugs ( DMARDs ) with prednisolone or a single DMARD with or without prednisolone for 2 years .\
METHODS	Treatment responses were evaluated according to the American College of Rheumatology ( ACR ) criteria .\
METHODS	After a 5-year followup , the cumulative number of days of sick leave and RA-related permanent work disability was calculated for each of the 162 patients who were available for the active work force at baseline .\
RESULTS	Of the 159 patients assessed at 6 months , 29 were in clinical remission , 66 achieved an ACR50 response but not remission , 29 achieved an ACR20 response but not an ACR50 response , and 35 failed to achieve an ACR20 response .\
RESULTS	In these 4 groups , the median numbers of work disability days per patient-year from 6 months through 60 months of followup were 0 ( interquartile range [ IQR ] 0-3 ) , 4 ( IQR 0-131 ) , 16 ( IQR 0-170 ) , and 352 ( 16-365 ) , respectively ( P < 0.001 ) .\
RESULTS	Pairwise multiple comparisons showed a statistically significant difference between all groups except the ACR50 and ACR20 groups .\
RESULTS	At 12 months , 30 patients were in remission .\
RESULTS	None of the 44 patients in remission at 6 or 12 months became permanently work disabled over the 5-year followup , as compared with 15 patients in the ACR50 group ( 23 % ) , 6 in the ACR20 group ( 21 % ) , and 19 without an ACR20 response at 6 months ( 56 % ) .\
CONCLUSIONS	Prompt induction of remission translates into maintenance of work capacity .\
CONCLUSIONS	At 6 months , an ACR50 response is no better than an ACR20 response with regard to future productivity , while failure to achieve an ACR20 response carries a high risk for work disability .\
\
###10211174\
BACKGROUND	A past history of major depression or alcoholism has been associated with poorer smoking treatment outcomes .\
OBJECTIVE	To evaluate the efficacy of bupropion for smoking cessation in smokers with a former history of major depression or alcoholism , and changes in depressive symptoms during smoking abstinence .\
METHODS	Data were drawn from a multicentre trial of bupropion for smoking cessation .\
METHODS	Smokers ( n = 615 ) received placebo or bupropion sustained-release at 100 , 150 , or 300 mg/day for six weeks after target quit date ( TQD ) .\
METHODS	The primary outcome was the point prevalence smoking abstinence at the end of treatment and at one year .\
METHODS	The Beck Depression Inventory ( BDI ) was used to assess depressive symptoms .\
RESULTS	A significant dose-response effect of bupropion for smoking cessation was found .\
RESULTS	This was independent of history of major depression or alcoholism .\
RESULTS	Among those continuously abstinent from smoking for two weeks following TQD , an increase in BDI score was associated with a return to smoking at end of treatment .\
CONCLUSIONS	Bupropion is efficacious for smoking cessation independently of a former history of major depression or alcoholism .\
CONCLUSIONS	Increases in depressive symptoms during an initial period of abstinence are associated with a return to smoking .\
\
###19593713\
OBJECTIVE	This research was conducted to examine the consequences of forewarning drivers about impending congestion on aggressive driving behavior .\
OBJECTIVE	Some have argued that aggressive driving stems from frustration experienced on the roadway ( often due to congestion ) , and that by warning drivers about congestion , frustration , and consequently aggressive driving , can be reduced .\
METHODS	The study employed an experimental design , where participants ( whose dispositional driver anger was measured using the Driver Anger Scale ) were instructed to operate an instrumented vehicle along a prescribed route containing construction .\
METHODS	Participants were randomly assigned either to receive a warning about the construction or to receive no warning about the congestion .\
METHODS	Measures of aggressive driving behavior were extracted from video ( shot from a camera hidden behind the vehicle 's license plate ) and from an ongoing accelerometer .\
RESULTS	A total of 49 participants completed the study .\
RESULTS	Analyses of combined measure of aggressive driving behavior data revealed a statistically significant main effect for dispositional driver anger ( with participants scoring higher on the scale actually driving more aggressively ) , as well as interactions between driver anger and forewarning .\
RESULTS	Accordingly , forewarning about potential congestion reduced aggressive driving behavior for participants high in dispositional anger but increased aggressive behavior for participants who were low on dispositional anger .\
CONCLUSIONS	Some of the results-particularly the increase in aggressive driving among participants low in dispositional driver anger who were warning about congestion-were unexpected .\
CONCLUSIONS	The interaction effect suggests that the strategy providing warnings about upcoming congestion will not necessarily reduce frustration among all drivers .\
\
###7970453\
OBJECTIVE	To test whether progesterone or progesterone receptors are important mediators of premenstrual syndrome ( PMS ) and whether progesterone antagonist RU 486 would alleviate symptoms .\
METHODS	Following extensive screening including physical and psychological assessment , seven women with severe PMS participated in a 6-month , randomized , double-blind , placebo-controlled , crossover study .\
METHODS	The treatment included 3 months of low-dose RU 486 ( 5 mg alternate days for four doses , beginning 3 days after the urinary LH surge ) or placebo , administered in a similar fashion .\
METHODS	Symptoms were evaluated using the Calendar of Premenstrual Experiences , Beck Depression Inventory , State-Trait Anxiety Inventory , and the Profile of Mood States .\
RESULTS	Symptoms of PMS were similar during RU 486 and placebo treatments .\
CONCLUSIONS	Luteal-phase administration of low-dose RU 486 does not significantly reduce the physical or behavioral manifestations of PMS .\
\
###2012087\
OBJECTIVE	The purpose of the study was to compare the powder and the bar forms of cholestyramine to determine efficacy and patient compliance .\
METHODS	A prospective , randomized trial was conducted that included 83 healthy men and women with hyperlipidemia greater than the 90th percentile for low-density lipoprotein ( LDL ) or total cholesterol .\
METHODS	Patients were randomly assigned to receive either cholestyramine powder , two packets ( 8 g ) , twice daily , or cholestyramine confectionery bar , in maple or mint flavors , two bars ( 8 g ) , twice daily .\
METHODS	Fasting serum total cholesterol , LDL cholesterol , high-density lipoprotein ( HDL ) cholesterol , and triglycerides were measured at baseline , after 6 to 8 weeks of following the American Heart Association Step I diet alone , and after 8 weeks of taking either the cholestyramine bar or powder .\
RESULTS	Total cholesterol decreased significantly ( p less than 0.01 ) by 16 % in the bar group and 17 % in the powder group .\
RESULTS	LDL cholesterol decreased by 28 % and 29 % in the bar and powder groups , respectively ( p less than 0.01 ) .\
RESULTS	There was no significant change in HDL cholesterol .\
RESULTS	Triglycerides increased in both groups , by 29 % in the bar group and by 25 % in the powder group .\
RESULTS	There was no difference between bar and powder in the effect on blood lipids .\
RESULTS	The majority of the lipid-lowering effect was seen within 14 days .\
RESULTS	Mean patient endpoint compliance with the therapy was 91.8 + / - 3.6 % in the bar group and 94.8 + / - 2.1 % in the powder group .\
RESULTS	There was no difference between groups .\
CONCLUSIONS	The cholestyramine confectionery bar is as effective as cholestyramine powder in the treatment of hyperlipidemia .\
CONCLUSIONS	The majority of the lipid-lowering effect is seen within 14 days of therapy .\
CONCLUSIONS	Although patient compliance is comparable between the two forms , gastrointestinal side effects were slightly greater with the bar form .\
CONCLUSIONS	Therefore , although the bar offers an alternative form of therapy , there appears to be no advantage with regard to patient compliance or palatability .\
\
###15588745\
BACKGROUND	Patients may be asked to register a symptom daily in clinical trials .\
BACKGROUND	A problem associated with this kind of registration is that patients do not always fill in the diary at the appropriate time .\
BACKGROUND	As there is evidence showing that memory is unreliable , this undermines the entire purpose of collecting daily data on paper diaries .\
BACKGROUND	We aimed to compare accuracy , autocorrelations of consecutive entries , and responsiveness in paper diaries ( P-Diaries ) with electronic diaries ( E-Diaries ) and telephone diaries ( T-Diaries ) .\
METHODS	In a multi-centre , open , and parallel trial , 177 patients were allocated at random to P-Diaries , E-Diaries , or T-Diaries for the registration of symptoms through 4 weeks of treatment of gastro-oesophageal reflux disease ( GORD ) .\
METHODS	The primary outcome measure was the diaries .\
RESULTS	The proportion of patients completing all morning and all evening entries on time was low for both E-Diary and T-Diary groups .\
RESULTS	By accepting entries that were done half a day late , the proportion was increased to 19/57 ( 33 % ) for the E-Diary group , and to 9/61 ( 15 % ) for the T-Diary group .\
RESULTS	For P-Diary , where no control for time registration and entries was adapted , 37/59 ( 63 % ) of the patients completed all morning and all evening entries .\
RESULTS	A significant higher autocorrelation in P-Diaries was also found .\
RESULTS	Responsiveness was similar regardless of method of data capture .\
CONCLUSIONS	The results are consistent with the suggestion that data in the P-Diaries are not filled in at the appropriate time .\
CONCLUSIONS	Use of E-Diaries or T-Diaries improves quality and is recommended in future clinical trials .\
\
###23560500\
BACKGROUND	Postoperative pain management for patients with inflammatory bowel disease ( IBD ) can be challenging .\
BACKGROUND	These patients have a high tolerance to pain medication , and relative contraindications to the use of epidural analgesia , limiting the pain management options .\
BACKGROUND	We evaluated the effect of a single preoperative gabapentin dose on opioid consumption for patients with IBD undergoing abdominal surgery .\
BACKGROUND	Secondary outcomes were postoperative pain scores , opioid-related side effects , and patient 's length of hospital stay .\
METHODS	Following Research Ethics Board approval and informed written consent , patients were randomly allocated into 2 groups receiving either 600 mg of oral gabapentin or placebo 1 hour before the surgery .\
METHODS	A blinded anesthesiologist recorded pain scores at rest and movement twice daily for 2 postoperative days .\
METHODS	Also recorded were opioid consumption , time of return of bowel function , time to discharge , and opioid-related side effects on the opioid-related symptom distress scale ( ORSDS ) .\
RESULTS	Seventy-two patients completed the study .\
RESULTS	The difference in opioid consumption ( P = 0.4169 ) and pain scores measured at rest and movement on all 4 postoperative visits was not statistically significant .\
RESULTS	There was no significant difference between gabapentin and placebo on all the 11 symptoms reported on the ORSDS .\
RESULTS	There was a slight increase in length of hospital stay in the placebo group , but the return of bowel function was similar between the groups .\
CONCLUSIONS	This study examined the effect of a single preoperative administration of gabapentin in patients with IBD undergoing major bowel surgery .\
CONCLUSIONS	Our results suggest a single preoperative oral dose of gabapentin 600 mg does not reduce postoperative pain scores , opioid consumption , or opioid-related side effects .\
\
###15596745\
OBJECTIVE	To investigate if IV immunoglobulins ( IVIg ) in combination with methylprednisolone make recovery from a relapse faster and more complete than methylprednisolone alone .\
OBJECTIVE	Design /\
METHODS	The authors studied 76 patients with multiple sclerosis ( MS ) who had an acute relapse with involvement of visual function , upper limb motor function , or gait , and with onset of symptoms between 24 hours and 14 days before .\
METHODS	Patients were treated with either IVIg 1 g/kg or placebo ( 0.1 % human albumin ) , given 24 hours before treatment with IV methylprednisolone 1 g on 3 consecutive days .\
RESULTS	Both groups improved , but the authors observed no significant difference between IVIg and placebo patients regarding the primary endpoint , the mean change in the Z-score of the individually chosen targeted neurologic deficit ( the most affected system ) from baseline to 12 weeks ( p = 0.89 ) .\
RESULTS	A slightly better , but not significant remission was seen in the IVIg group in global scores , i.e. , Expanded Disability Status Scale ( p = 0.23 ) and Multiple Sclerosis Impairment Scale ( p = 0.24 ) , and in time to next relapse ( p = 0.22 ) .\
CONCLUSIONS	The results do not justify routine application of IV immunoglobulins as add-on therapy to IV methylprednisolone in the treatment of acute multiple sclerosis attacks .\
\
###12121506\
OBJECTIVE	Non-response to interferon ( IFN ) monotherapy is a major therapeutic problem in the management of chronic hepatitis B infection .\
OBJECTIVE	The efficacy of combination therapy to enhance the immunomodulatory effect of IFN by combining granulocyte-macrophage colony-stimulating factor ( GMCSF ) or decreasing viral load by adding an antiviral agent such as lamivudine was evaluated prospectively .\
METHODS	Twenty-four patients with chronic hepatitis B who were non-responders to previous IFN therapy were randomized to receive an IFN and GMCSF ( group A , n = 10 ) or IFN and lamivudine ( group B , n = 14 ) combination for 6 months .\
METHODS	The end-of-treatment response was assessed by hepatitis B virus ( HBV ) - DNA and hepatitis B e antigen ( HBeAg ) determination .\
RESULTS	All patients successfully completed both the treatment schedules .\
RESULTS	The mean age , alanine aminotransferase ( ALT ) levels , liver histology , HBV-DNA levels and distribution of HBV genotypes were comparable between the two groups .\
RESULTS	At the end of treatment there was a significant decrease in mean ALT levels .\
RESULTS	The HBV-DNA and HBeAg loss was seen in six of 10 ( 60 % ) patients in group A and in seven of 14 ( 50 % ) patients in group B.\
RESULTS	During a mean follow-up of 15 + / - 3 months , two of six ( 33 % ) patients in group A and three of seven ( 43 % ) patients in group B relapsed with HBV-DNA and HBeAg positivity , which meant an overall sustained response of 40 % and 28 % , respectively .\
RESULTS	None of the factors such as HBV viral load , ALT levels or liver histology could predict the non-response to combination therapy or occurrence of relapse .\
RESULTS	There was a trend in patients with genotype A compared with genotype D towards non-response to therapy , although the difference was not significant .\
CONCLUSIONS	The combination of IFN plus GMCSF or lamivudine was effective in non-responders to IFN monotherapy .\
CONCLUSIONS	Larger studies using such combination therapies would be helpful in improving treatment strategies for chronic hepatitis B.\
\
###15927063\
BACKGROUND	The burden of proteinases from inflammatory cells in the lung of subjects with type Pi ZZ of alpha-1-antitrypsin deficiency is higher than in those without the deficiency .\
BACKGROUND	Cross-sectional studies have shown increased levels of biomarkers of extracellular matrix degradation in vivo .\
BACKGROUND	Longitudinal variability of these biomarkers is unknown but desirable for clinical studies with proteinase inhibitors .\
METHODS	We measured three different types of biomarkers , including desmosines , elastase-formed fibrinogen fragments and heparan sulfate epitope JM403 , in plasma and urine for a period of 7 weeks in a group of 12 patients who participated in a placebo-controlled study to assess the safety of a single inhalation of hyaluronic acid .\
RESULTS	Effect of study medication on any of the biomarkers was not seen .\
RESULTS	Baseline desmosines in plasma and urine correlated with baseline CO diffusion capacity ( R = 0.81 , p = 0.01 and R = 0.65 , p = 0.05 ) .\
RESULTS	Mean coefficient of variation within patients ( CVi ) for plasma and urine desmosines was 18.7 to 13.5 % , respectively .\
RESULTS	Change in urinary desmosine levels correlated significantly with change in plasma desmosine levels ( R = 0.84 , p < 0.01 ) .\
RESULTS	Mean CVi for fibrinogen fragments in plasma was 20.5 % and for JM403 in urine was 27.8 % .\
RESULTS	No correlations were found between fibrinogen fragments or JM403 epitope and desmosines .\
CONCLUSIONS	We found acceptable variability in our study parameters , indicating the feasibility of their use in an evaluation of biochemical efficacy of alpha-1-antitrypsin augmentation therapy in Pi Z subjects .\
\
###18271226\
OBJECTIVE	To probe into clinical therapeutic effect of acupuncture on diabetic nephropathies and the mechanism .\
METHODS	Using multi-central , randomized and blind methods , 130 cases of diabetic nephropathy were divided into an observation group and a control group , 65 cases in each group .\
METHODS	They were treated by routine diabetic therapy , and in the observation group , acupuncture at Quchi ( LI 11 ) , Zhigou ( TE 6 ) , Hegu ( LI 4 ) , Xuehai ( SP 10 ) , Zusanli ( ST 36 ) , Yinlingquan ( SP 9 ) , Fenglong ( ST 40 ) , Diji ( SP 8 ) , Sanyinjiao ( SP 6 ) , Taichong ( LR 3 ) , Tianshu ( ST 25 ) , Gaohuang ( BL 43 ) , Shenshu ( BL 23 ) , Zhongwan ( CV 12 ) , Zhongji ( CV 3 ) were added with needling method of harmonizing spleen-stomach .\
METHODS	While in the control group , acupuncture at Shenshu ( BL 23 ) , Taixi ( KI 3 ) , Sanyingjiao ( SP 6 ) , Yanglingquan ( GB 34 ) , Xuanzhong ( GB 39 ) , Guanyuan ( CV 4 ) , Shousanli ( LI 10 ) , Waiguan ( TE 5 ) , Yangxi ( LI 5 ) , Liangqiu ( ST 34 ) , Shangjuxu ( ST 37 ) , Neiting ( ST 44 ) , Huaroumen ( ST 24 ) , Dachangshu ( BL 25 ) .\
METHODS	The treatment was given twice a day in the two groups .\
METHODS	Clinical therapeutic effects were assessed according to clinical symptoms and signs , blood sugar , blood lipids , urinary albumin excretion rate , urinary monocyte chemotactic protein-1 ( MCP-1 ) , glomerular filtration rate ( GFR ) , renal blood flow , etc. .\
RESULTS	The needling method of harmonizing spleen-stomach not only could improve symptoms and signs of the patients , and also had benign regulative action on metabolism of blood sugar and lipids , and GFR , renal blood flow and urinary albumin level , with significant or very significant differences as compared with the control group ( P < 0.05 or P < 0.01 ) .\
CONCLUSIONS	The needling method of harmonizing spleen-stomach is an effective method for diabetic nephropathies , which can improve progressive renal lesion induced by abnormal metabolism of blood sugar and lipids , improve renal blood flow and GFR , decrease urinary albumin secretion , inhibit over expression of MCP-1 , protect glomerulus and renal tubules , so as to improve renal function and delay renal lesion .\
\
###15188939\
BACKGROUND	Arterial hypertension is a major risk factor for cardiovascular events .\
BACKGROUND	The prognosis for hypertensive patients after acute myocardial infarction ( MI ) is uncertain because of the sparse and somewhat contradictionary data .\
OBJECTIVE	Our study aimed to investigate the importance of hypertension to prognosis after an MI in patients receiving contemporary medical therapy .\
METHODS	We performed a retrospective study using a large register from the Bucindolol Evaluation in Acute myocardial infarction Trial ( BEAT ) .\
METHODS	The register comprised 3,326 patients admitted between June 1998 and August 1999 with an enzyme-verified MI to 33 Danish coronary care units .\
METHODS	Hypertension was considered present when a previous diagnosis of hypertension was accompanied by relevant medical therapy .\
METHODS	Survival information for all patients was obtained in January 2002 .\
RESULTS	Of the 3,326 patients studied , 825 were hypertensive .\
RESULTS	Overall , 28.4 % had died by January 2002 .\
RESULTS	The unadjusted hazard ratio associated with hypertension was 1.2 ( 95 % confidence limit [ CI ] 1.1-1 .4 , p = 0.004 ) .\
RESULTS	Hypertensive patients were older , and after adjustment for age the hazard ratio associated with hypertension was 1.04 ( CI 0.9-1 .2 , p = 0.6 ) .\
RESULTS	Adjustment for further covariates did not change the result .\
CONCLUSIONS	Our study showed that after an acute MI the survival rate of patients with and without a history of hypertension was identical when they received contemporary medical therapy .\
\
###10758949\
OBJECTIVE	To evaluate the long-term outcome of patients randomized to coronary bypass surgery or coronary angioplasty .\
BACKGROUND	The Emory Angioplasty versus Surgery Trial ( EAST ) is a single center randomized comparison of a strategy of initial coronary angioplasty ( n = 198 ) or coronary bypass surgery ( n = 194 ) for patients with multivessel coronary artery disease .\
BACKGROUND	The primary end point ( death , myocardial infarction or a large ischemic defect at 3 years ) was not different , and repeat revascularization was significantly greater in the angioplasty group .\
BACKGROUND	Subsequently , the National Heart , Lung and Blood Institute supported a five-year extension of the trial .\
METHODS	After the three year anniversary visit , annual questionnaires , telephone contact and examination of medical records were accomplished until death or the eight year anniversary in 100 % of the patients surviving at 3 years .\
RESULTS	Survival at 8 years is 79.3 % in the angioplasty group and 82.7 % in the surgical group ( p = 0.40 ) .\
RESULTS	Patients with proximal left anterior descending stenosis and those with diabetes tended to have better late survival with surgical intervention although not reaching statistical significance .\
RESULTS	After the first 3 years , repeat interventions remained relatively equal for both treatment groups .\
CONCLUSIONS	Long-term survival is not significantly different between angioplasty and surgery , and late ( three to eight year ) revascularization procedures were infrequent .\
CONCLUSIONS	Patients without treated diabetes had similar survival in both groups .\
\
###25154607\
BACKGROUND	Microvascular angina ( MVA ) is characterized by anginal chest pain , an abnormal stress test , and normal coronary arteries on coronary angiography .\
BACKGROUND	Although the exact pathogenesis remains unclear , endothelial dysfunction is a contributing factor .\
BACKGROUND	To date , there exists no specific therapy for this disease .\
BACKGROUND	Phosphodiesterase-5 inhibitor improves the endothelial function and subsequently microvascular circulation .\
BACKGROUND	The aim of this study is to identify whether udenafil offers benefits in the treatment of MVA in female patients , who have a perfusion defect in their cardiac magnetic resonance image ( CMR ) , but normal coronary arteries .\
METHODS	The ` Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image : ( UMPIRE ) ' trial is a multicenter , prospective , randomized , placebo controlled trial , designed to evaluate the effect of udenafil on myocardial ischemia and symptoms in female patients with MVA .\
METHODS	The myocardial ischemia will be quantified by myocardial stress perfusion defect in CMR .\
METHODS	A total of 80 patients with proven perfusion defect in adenosine-stress CMR will be randomly assigned to either the udenafil treatment group ( daily dose of 100mg ) or the placebo group for three months .\
METHODS	The primary endpoint is > 25 % improvement in perfusion defect size in adenosine-stress CMR from baseline .\
METHODS	The secondary endpoints include < 25 % improvement in perfusion defect size , chest pain frequency , ST depression in stress test , Duke score in stress test , quality of life ( QoL ) assessment by SF-36 questionnaire , sexual dysfunction assessment by BISF-W ( Brief Index of Sexual Functioning for Women ) self-assessment questionnaire , and biomarkers for endothelial function .\
CONCLUSIONS	The UMPIRE trial is the first randomized controlled trial to evaluate the efficacy of udenafil in female MVA patients .\
CONCLUSIONS	If udenafil demonstrates cardioprotective effects , it may provide a novel therapeutic option to reduce myocardial ischemia and improve cardiac function in female MVA patients .\
BACKGROUND	Clinical Trials.gov : NCT01769482 ( registered on 20 November 2012 ) .\
\
###23392267\
BACKGROUND	Patients with depression are treated for a relatively long period as inpatients in Germany .\
BACKGROUND	A new treatment model with symptom-orientated release management , post-hospitalization treatment and standardized referral to outpatient therapists could be suitable to specifically shorten the hospital stay of patients who have already profited sufficiently from treatment .\
METHODS	The aim of the present study was to investigate the effects of a new treatment method ( intervention group ) with hospitalized depressive patients in comparison to a standard protocol ( treatment-as-usual control group ) on the length of stay as part of a pragmatic randomized , controlled multicentre study .\
METHODS	The evaluation was made using covariance analysis .\
RESULTS	Of the 202 randomized patients 184 could be included in the analysis .\
RESULTS	The estimated marginal mean of the length of stay ( n = 83 ) was 57.3 days ( range 1-305 days , SE = 3.8 ) in the intervention group and ( n = 101 ) 57.6 days ( range : 6-196 days , SE = 3.5 ) in the control group .\
RESULTS	There were no significant statistical differences between the groups ( p = 0.966 ) .\
CONCLUSIONS	An effect of the new treatment model on the inpatient length of hospital stay in depressive patients could not be demonstrated .\
\
###11862375\
BACKGROUND	Co-morbidity of mood and anxiety disorders is often ignored in pharmacotreatment outcome studies and this complicates the interpretation of treatment response .\
BACKGROUND	The clinical trials are usually based on single categories from the Diagnostic and Statistical Manual of Mental Disorders ( DSM ) .\
OBJECTIVE	The present study is a first attempt to differentiate the responses to antidepressants using a design that differs from that used in previous clinical trials .\
OBJECTIVE	To avoid bias due to co-morbidity , we included patients with any DSM-III-R diagnosis of mood or anxiety disorder for which antidepressant treatment was indicated .\
OBJECTIVE	We also explored the role of the diagnosis at the first episode in the efficacy of the different antidepressants .\
METHODS	A total of 92 outpatients with a mood and/or anxiety disorder were randomly assigned to treatment with imipramine or fluvoxamine in a 6-week study .\
METHODS	The diagnosis at the first episode -- or primary diagnosis -- was available for 78 patients , 40 with a primary depression and 38 with a primary anxiety disorder .\
RESULTS	Analyses using the MIXED procedure for repeated measures showed no general differences between treatment with imipramine and treatment with fluvoxamine .\
RESULTS	When the primary diagnoses were taken into consideration , differentiation occurred .\
RESULTS	Patients with primary depression showed better responses to imipramine than to fluvoxamine .\
RESULTS	The assumption that patients with primary anxiety disorder would respond better to fluvoxamine than imipramine was observed for only the Clinical Global Impression .\
CONCLUSIONS	The results suggest that the nature of the first illness episode may be more valuable than the DSM categories of mood or anxiety disorders , which may lend support to the concept of primary versus secondary depression for purposes of differentiating treatment responses .\
CONCLUSIONS	Given the exploratory nature of the study , however , replication of our finding is needed .\
\
###8335655\
BACKGROUND	Anxiety and hyperarousal constitute important aspects of obsessive compulsive disorder ( OCD ) .\
BACKGROUND	This study examined the effects of clomipramine on symptoms , arousal-related physiologic states , and stress reactions in OCD patients .\
METHODS	Twenty-five OCD patients were randomly assigned to a clomipramine or placebo group and were assessed for 10 weeks using a double-blind parallel design .\
METHODS	They were assessed clinically with the Yale-Brown Obsessive Compulsive Scale , the National Institute of Mental Health Global Obsessive-Compulsive Scale , the patient - and investigator-rated Global Improvement Scales , and the Hamilton Rating Scale for Depression .\
METHODS	Prior to treatment , and again during the last day of medication , physiologic states ( heart rate , respiration , skin conductance , blood pressure , and EMG ) were measured at rest and during both nonspecific ( psychomotor tasks ) and pathology-specific ( visualization ) stressors .\
RESULTS	Patients taking clomipramine , but not those taking placebo , improved significantly on all clinical measures .\
RESULTS	With the exception of heart rate , treatment did not affect resting physiologic states .\
RESULTS	Heart rate increased in patients taking clomipramine and decreased in patients taking placebo .\
RESULTS	Autonomic reactivity to nonspecific and to pathology-specific stressors was attenuated by clomipramine , but not by placebo .\
CONCLUSIONS	Clinical improvement on clomipramine treatment was independent of the physiologic state of the patients and was not associated with autonomic down-regulation .\
CONCLUSIONS	The attenuation of autonomic reactivity to stressors appears not to be pathology-specific but may reflect either a direct pharmacologic effect of clomipramine on the autonomic nervous system or a heightened indifference to psychological stressors in general .\
\
###19808745\
BACKGROUND	The most important side effect of epidural anesthesia is hypotension with functional hypovolemia .\
BACKGROUND	Aggressive infusion therapy can reduce the hypotension effect .\
BACKGROUND	However , in conjunction with cardiopulmonary bypass , it can increase acute lung injury .\
BACKGROUND	We hypothesized that epidural anesthesia , by reducing cardiac sympathetic tonus , with subsequent better pulmonary flow , does not increase lung interstitial fluids .\
METHODS	Sixty patients undergoing coronary artery bypass graft ( CABG ) surgery with cardiopulmonary bypass ( CPB ) were randomized to combined general anesthesia with epidural anesthesia / analgesia , ( EA ) group , and to general anesthesia with i/v opiate analgesia , ( GA ) group .\
METHODS	Patients in the EA group received a high thoracic epidural , preoperatively .\
METHODS	Intraoperatively , 0.25 % bupivacaine 8 mL/h was infused and general anesthesia with sevoflurane was followed by bupivacaine infusion for 48 hours postoperatively .\
METHODS	General anesthesia in the GA group was with sevoflurane and fentanyl 10 - 12 microg/kg and analgesia with pethidinum 0.1 - 0.4 mg/kg i.v. postoperatively .\
METHODS	Global end-diastolic volume index ( GEDI ) , intrathoracic blood volume index ( ITBI ) and extravascular lung water index ( ELWI ) were measured before anesthesia , before CPB and 15 , 60 , 180 , 600 min .\
METHODS	and 24 hr after CPB .\
METHODS	Duration of mechanical lung ventilation was registered in both groups .\
RESULTS	ITBI and GEDI were significantly higher in the EA group at all time points of measurement ( ITBI 945.6 + / -146.4 ml/m ( 2 ) and 870.6 + / -146.5 ml/m ( 2 ) vs. 1118 + / -153.2 ml/m ( 2 ) and 1020 + / -174.9 ml/m ( 2 ) ; GEDI 720 + / -96.19 ml/m ( 2 ) and 775.0 + / -159.5 ml/m ( 2 ) vs. 805.4 + / -97.59 ml/m ( 2 ) and 888 + / -117.3 ml/m ( 2 ) ) .\
RESULTS	GEDI was significantly lower in the GA group compared with baseline ( 801.9 + / -132.4 ml/m ( 2 ) vs. 695 + / -169.2 mL/m ( 2 ) ) .\
RESULTS	ELWI was significantly higher in the GA group ( 7.233 + / -1.35 ml/kg and 7.333 + / -1.32 ml/kg vs. 8.533 + / -1.45 ml/kg and 8.633 + / -1.71 ml/kg ) , but without significant changes in the EA group .\
RESULTS	Duration of mechanical lung ventilation was shorter in the EA group ( 663.7 + / -98.39 min .\
RESULTS	vs. 362.2 + / -33.72 min . )\
CONCLUSIONS	Epidural anesthesia / analgesia does not increase interstitial lung fluids by increasing intrathoracic blood volume or the amount of infusion fluids in patients undergoing cardiac surgery under cardiopulmonary bypass .\
CONCLUSIONS	There is , also , a decreased duration of mechanical lung ventilation .\
\
###23350920\
OBJECTIVE	To examine the role of baseline depression , anxiety and stress symptoms on post-intervention diabetes self-efficacy and glycaemic control ( HbA ( 1c ) ) .\
METHODS	The current study analysed data from patients ( n = 85 ) with treated but uncontrolled Type 2 diabetes who participated in a comparative effectiveness study of two diabetes self-management interventions .\
METHODS	Hierarchical linear regression was used to examine the relationships between baseline affective symptoms and post-intervention diabetes self-efficacy and the moderating effects of baseline affective symptoms on the relationship between changes in diabetes self-efficacy and post-intervention HbA ( 1c ) .\
RESULTS	Baseline depression was inversely associated with post-intervention diabetes self-efficacy ( P = 0.0001 ) after adjusting for baseline characteristics including diabetes self-efficacy .\
RESULTS	In contrast , normal-mild levels of stress were associated with higher post-intervention diabetes self-efficacy ( P = 0.04 ) .\
RESULTS	Anxiety and stress symptoms significantly and independently moderated the relationship between changes in diabetes self-efficacy and post-intervention HbA ( 1c ) ( P = 0.02 and P = 0.03 , respectively ) .\
RESULTS	Further evaluation of these interactions demonstrated that changes in diabetes self-efficacy were associated with lower post-intervention HbA ( 1c ) , but only among those with higher baseline affective symptoms .\
CONCLUSIONS	We found a moderating effect across affective symptoms on the relationship between diabetes self-efficacy changes and post-intervention HbA1c in the context of a self-management intervention .\
CONCLUSIONS	Results suggest that patients with poorly controlled diabetes who have higher levels of depression , anxiety and stress symptoms may derive greater benefits from self-management interventions known to improve diabetes self-efficacy .\
\
###25443423\
OBJECTIVE	To test the efficacy of a Stress Management and Resiliency Training ( SMART ) program for decreasing stress and anxiety and improving resilience and quality of life among Department of Radiology physicians .\
METHODS	The study was approved by the institutional review board .\
METHODS	A total of 26 Department of Radiology physicians were randomized in a single-blind trial to either the SMART program or a wait-list control arm for 12 weeks .\
METHODS	The program involved a single 90-min group session in the SMART training with two follow-up phone calls .\
METHODS	Primary outcomes measured at baseline and week 12 included the Perceived Stress Scale , Linear Analog Self-Assessment Scale , Mindful Attention Awareness Scale , and Connor-Davidson Resilience Scale .\
RESULTS	A total of 22 physicians completed the study .\
RESULTS	A statistically significant improvement in perceived stress , anxiety , quality of life , and mindfulness at 12 weeks was observed in the study arm compared to the wait-list control arm ; resilience also improved in the active arm , but the changes were not statistically significant when compared to the control arm .\
CONCLUSIONS	A single session to decrease stress among radiologists using the SMART program is feasible .\
CONCLUSIONS	Furthermore , the intervention afforded statistically significant and clinically meaningful improvement in anxiety , stress , quality of life , and mindful attention .\
CONCLUSIONS	Further studies including larger sample size and longer follow-up are warranted .\
\
###14594788\
BACKGROUND	Older persons are at risk of both poor nutrition and increased oxidative stress .\
BACKGROUND	Plasma ascorbate concentrations fall with increasing age , and concentrations of other antioxidants may also be reduced .\
OBJECTIVE	The goal was to examine the association between antioxidants and mortality in older persons .\
METHODS	We randomly selected persons aged 75-84 y from the lists of 51 British family practitioners taking part in a randomized trial of assessment of older persons .\
METHODS	A total of 1214 participants provided a blood sample and were interviewed about their usual diet with the use of a food-frequency questionnaire .\
METHODS	Statistical analyses were based on deaths after a median of 4.4 y of follow-up , and hazard ratios were estimated for quintiles of dietary or blood antioxidants .\
RESULTS	We found strong inverse trends for blood ascorbate concentrations with all-cause and cardiovascular disease mortality , which were only marginally reduced after adjustment for confounders or supplement use .\
RESULTS	Those in the lowest fifth ( < 17 micromol/L ) had the highest mortality , whereas those in the highest fifth ( > 66 micromol/L ) had a mortality risk nearly half that ( hazard ratio = 0.54 ; 95 % CI : 0.34 , 0.84 ) .\
RESULTS	Similar results were found after the exclusion of those subjects with cardiovascular disease or cancer at baseline ( hazard ratio = 0.51 ; 0.28 , 0.93 ) .\
RESULTS	In fully adjusted models , there was no evidence for an influence of alpha-tocopherol , beta-carotene , or retinol on total mortality .\
RESULTS	Dietary antioxidants measured by the food-frequency questionnaire were not associated with all-cause or cardiovascular disease mortality .\
CONCLUSIONS	Low blood vitamin C concentrations in the older British population are strongly predictive of mortality .\
\
###11016328\
BACKGROUND	Diltiazem is widely used to prevent radial artery spasm after coronary bypass grafting ( CABG ) .\
BACKGROUND	However , recent in vitro and in vivo studies have shown that nitroglycerin is a superior conduit vasodilator compared to diltiazem .\
BACKGROUND	A clinical comparison of these agents in patients undergoing CABG has not been previously performed .\
METHODS	One hundred sixty-one consecutive patients undergoing isolated CABG with the radial artery were prospectively randomized to 24-hour intravenous infusion of nitroglycerin or diltiazem followed by 6-month treatment with a daily dose of isosorbide mononitrate ( n = 84 ) or diltiazem CD ( n = 77 ) .\
METHODS	Analyses were performed on `` intention-to-treat '' basis .\
RESULTS	Crossovers because of low cardiac output , complete heart block , or sinus bradycardia occurred in 5 patients in the diltiazem group and none in the nitroglycerin group ( p = 0.05 ) .\
RESULTS	Operative mortality ( nitroglycerin , 1.2 % versus diltiazem , 1.3 % ) , major morbidity ( 14 % versus 16 % ) , perioperative myocardial infarction ( 1.2 % versus 0 % ) , peak serum creatinine phosphokinase MB fraction levels ( 27 versus 21 U ) , intensive care unit stay ( 34 + / -19 versus 38 + / -30 hours ) and total hospital length of stay ( 4.7 + / -1.4 versus 4.7 + / -1.3 days ) were similar ( p = not significant for all ) .\
RESULTS	Cardiac pacing was required more often in the diltiazem group ( 28 % versus 13 % , p = 0.01 ) .\
RESULTS	Follow-up longer than 2 months was available in 145 patients ( 90 % ) .\
RESULTS	Follow-up mortality ( nitroglycerin , 1.2 % ; diltiazem , 1.3 % ) , myocardial infarction ( 6 % , versus 5 % ) , and reintervention ( 8 % versus 6 % ) rates and average angina class ( 1.3 + / -0.7 versus 1.1 + / -0.4 ) were similar ( p = not significant for all ) .\
RESULTS	Thallium stress test obtained in 117 patients showed abnormal perfusion in the radial artery territory in only 4 patients ( 3 % ) , 2 in each group ( p = not significant ) .\
RESULTS	Treatment with diltiazem was more costly ( $ 16,340 versus $ 1,096 ) .\
CONCLUSIONS	Nitroglycerin is preferable to diltiazem for prevention of conduit spasm .\
CONCLUSIONS	Nitroglycerin is safe , effective , better tolerated , and less costly than diltiazem , and therefore , should be the agent of choice .\
\
###19858871\
BACKGROUND	An auditory perceptual learning paradigm was used to investigate whether implicit memories are formed during general anesthesia .\
METHODS	Eighty-seven patients who had an American Society of Anesthesiologists physical status of I-III and were scheduled to undergo an elective surgery with general anesthesia were randomly assigned to one of two groups .\
METHODS	One group received auditory stimulation during surgery , whereas the other did not .\
METHODS	The auditory stimulation consisted of pure tones presented via headphones .\
METHODS	The Bispectral Index level was maintained between 40 and 50 during surgery .\
METHODS	To assess learning , patients performed an auditory frequency discrimination task after surgery , and comparisons were made between the groups .\
METHODS	General anesthesia was induced with thiopental and maintained with a mixture of fentanyl and sevoflurane .\
RESULTS	There was no difference in the amount of learning between the two groups ( mean + / - SD improvement : stimulated patients 9.2 + / - 11.3 Hz , controls 9.4 + / - 14.1 Hz ) .\
RESULTS	There was also no difference in initial thresholds ( mean + / - SD initial thresholds : stimulated patients 31.1 + / - 33.4 Hz , controls 28.4 + / - 34.2 Hz ) .\
RESULTS	These results suggest that perceptual learning was not induced during anesthesia .\
RESULTS	No correlation between the bispectral index and the initial level of performance was found ( Pearson r = -0.09 , P = 0.59 ) .\
CONCLUSIONS	Perceptual learning was not induced by repetitive auditory stimulation during anesthesia .\
CONCLUSIONS	This result may indicate that perceptual learning requires top-down processing , which is suppressed by the anesthetic .\
\
###21681619\
OBJECTIVE	In the aftermath of myocardial infarction , increased loading conditions will trigger hypertrophy of viable myocardium .\
OBJECTIVE	This in turn causes deterioration of regional contractility .\
OBJECTIVE	Cardiac magnetic resonance imaging ( cMRI ) allows the exact differentiation of viable and infarcted myocardium and therefore the measurement of regional wall thickness and function .\
OBJECTIVE	Bone marrow-derived stem cell ( BMC ) transfer has been shown to improve global function and remodeling .\
OBJECTIVE	The present study examines the effect of BMC transfer on regional remodeling and function after myocardial infarction by cMRI .\
METHODS	Fifty-four patients of the MR substudy of the REPAIR-AMI trial have been studied at baseline and 12-month follow-up .\
METHODS	Enddiastolic wall thickness ( EDWT ) and wall thickening ( WT % ) have been measured on SSFP cine sequences .\
RESULTS	Enddiastolic wall thickness decreased in both placebo and BMC groups in viable as well as infarcted segments .\
RESULTS	The effect was largest in the pre-specified subgroup of patients below the median EF of 48.9 % ( infarcted segments -1.14 mm Placebo vs. -1.91 mm BMC , p for interaction 0.01 , remote segments -0.19 mm Placebo vs. -0.94 mm BMC , p for interaction 0.00001 ) .\
RESULTS	Corrected for baseline values BMC therapy yielded smaller EDWT at 12 months in infarcted and remote segments ( infarcted 7.58 mm Placebo vs. 6.13 mm BMC p = 0.0001 , remote 8.76 mm Placebo vs. 7.32 mm BMC , p = 0.0001 ) .\
RESULTS	This was associated with better contractility within the infarcted segments among BMC patients ( WT % 24.17 % Placebo vs. 49.31 % BMC , p = 0.0001 ) .\
RESULTS	The WT % was inversely correlated with EDWT ( r = -0.37 , p = 0.0001 ) .\
CONCLUSIONS	Bone marrow-derived stem cell therapy yields smaller EDWT when compared with placebo patients suggesting a positive effect on maladaptive hypertrophy of viable myocardium .\
CONCLUSIONS	This notion is supported by the enhanced regional contractility within the BMC group which is inversely correlated with EDWT .\
\
###21199584\
BACKGROUND	The Vaccine Assessment using Linked Data ( VALiD ) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage .\
BACKGROUND	A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent .\
BACKGROUND	This paper describes the rationale for the trial and provides an overview of the design and methods .\
METHODS	Single-centre , single-blind , randomised controlled trial ( RCT ) stratified by firstborn status .\
METHODS	Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form , along with information explaining data linkage .\
METHODS	The primary outcome at 10 weeks post-partum was parental participation in each arm , as indicated by the respective return or non-return of a reply form ( or via telephone or email response ) .\
METHODS	A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form , and attitudes and knowledge about data linkage , vaccine safety , consent preferences and vaccination practices .\
METHODS	Enrolment began in July 2009 and 1,129 households were recruited in a three-month period .\
METHODS	Analysis has not yet been undertaken .\
METHODS	The participation rate and selection bias for each method of consent will be compared when the data are analysed .\
CONCLUSIONS	The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour , and socioeconomic factors .\
CONCLUSIONS	The limitations to generalisability are discussed .\
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12610000332022 .\
\
###11125687\
BACKGROUND	In an attempt to demonstrate the peripheral effect of ketamine on the synovia of knee joint and to smoothen the recovery from arthroscopic knee surgery , this study was designed to evaluate the analgesic effect of intra-articular ketamine injection after knee arthroscopy .\
METHODS	In a double blind randomized study , 60 patients were assigned to three groups .\
METHODS	Group A patients received saline 5 mL intra-articularly after closure of the surgical wound to serve as control ; group B patients received ketamine 0.5 mg/kg of body weight intra-muscularly to rule out the systemic effect and group C patients received ketamine 0.5 mg/kg of body weight diluted with saline up to 5 mL intra-articularly .\
METHODS	After surgery , patients were evaluated for pain with visual analogue scale ( VAS 0 to 10 ) for 24 h with the operated leg in the position of extension rest and active flexion of the knee joint to 60 degree angle .\
METHODS	Rescue pethidine ( 1 mg/kg of body weight ) was given intra-muscularly for pain relief at request every 4 h postoperatively if necessary .\
METHODS	The time to first rescue analgesic request was recorded , and the total doses of pethidine were calculated .\
RESULTS	The results showed no difference in the VAS pain scores at rest and during active motion in the range of 60 degree among three groups during a 24 h observation .\
CONCLUSIONS	Ketamine had been reported to have peripheral analgesic effects with variable duration on measurements of pain and hyperalgesia .\
CONCLUSIONS	However , in the present study , we failed to demonstrate that ketamine could provide a clinically relevant peripheral analgesic effect for postoperative arthroscopic pain .\
\
###9693934\
BACKGROUND	It has been hypothesized that metformin inhibits food intake , but in humans such effect needs to be demonstrated .\
BACKGROUND	Our study aims at investigating the effect of metformin administration on food intake in obese , non-diabetic , normotensive patients .\
METHODS	Thirty patients underwent a double-blind , randomized study .\
METHODS	Placebo ( P ; n = 15 ) and metformin ( M ; n = 15 ) were both given for 15 days , and food intake ( FI ) was recorded at baseline and in the last 4 days of each treatment period .\
RESULTS	M administration allowed a stronger decline in body weight ( BW ) ( -2.8 + / - 1.6 vs. -0.3 + / - 0.4 kg P < 0.01 ) , body fat ( BF ) ( -1.4 + / - 1.2 vs. -0.3 + / - 1.1 kg P < 0.01 ) , plasma leptin concentration ( -5.2 + / - 8.9 vs. -1.8 + / - 10.4 ng mL-1 P < 0.05 ) and FI ( -642 + / - 491 vs.-70 + / - 1165 kJ per 24 h P < 0.01 ) than P.\
RESULTS	In M-treated subjects , changes in FI significantly correlated with those in BW ( r = 0.63 , P < 0.007 ) and BF ( r = 0.74 , P < 0.001 ) .\
RESULTS	Independently of sex and change in BF , the changes in FI and in fasting plasma leptin concentration ( r = 0.58 , P < 0.01 ) were still correlated .\
CONCLUSIONS	Our study suggests that metformin administration is useful to inhibit FI and to lower BW and BF in obese non-diabetic patients .\
\
###20470379\
BACKGROUND	A population of breast cancer patients exists who , for various reasons , never received adjuvant post-operative tamoxifen ( TAM ) .\
BACKGROUND	This study was aimed to evaluate the role of late TAM in these patients .\
METHODS	From 1997 to 2003 , patients aged 35 to 75 years , operated more than 2 years previously for monolateral breast cancer without adjuvant TAM , with no signs of metastases and no contraindication to TAM were randomized to TAM 20 mg/day orally for 2 years or follow-up alone .\
METHODS	Events were categorized as locoregional relapse , distant metastases , metachronous breast cancer , tumours other than breast cancer and death from any causes , whichever occurred first .\
METHODS	The sample size ( 197 patients per arm , plus 10 % allowance ) was based on the assumption of a 30 % decrease in the number of events occurring at a rate of 5 % annually in the 10 years following randomization .\
METHODS	Four hundred and thirty-three patients were randomized in the study ( TAM 217 , follow-up 216 ) .\
METHODS	Patients characteristics ( TAM/follow-up ) included : median age 55/55 years , median time from surgery 25/25 months ( range , 25-288/25 -294 ) , in situ carcinoma 18/24 , oestrogen receptor ( ER ) positive in 75/68 , negative in 70/57 , unknown in 72/91 patients .\
METHODS	Previous adjuvant treatment included chemotherapy in 131/120 and an LHRH analogue in 11/13 patients .\
RESULTS	Thirty-six patients prematurely discontinued TAM after a median of 1 month , mostly because of subjective intolerance .\
RESULTS	Eighty-three events ( TAM 39 , follow-up 44 ) occurred : locoregional relapse in 10/8 , distant metastases in 14/16 , metachronous breast cancer in 4/10 , other tumours in 11/10 patients .\
RESULTS	Less ER-positive secondary breast cancers occurred in the TAM treated patients than in follow-up patients ( 1 vs 10 , p = 0.005 ) .\
RESULTS	Event-free survival was similar in both groups of patients .\
CONCLUSIONS	This 5-year analysis revealed significantly less metachronous ER-positive breast cancers in the TAM treated patients .\
CONCLUSIONS	No other statistically significant differences have emerged thus far .\
\
###23519225\
BACKGROUND	Electroconvulsive therapy ( ECT ) continues to be an effective treatment option for patients who fail to respond to pharmacological interventions , are unable to tolerate medications , and show a suboptimal response to behavioral and psychotherapeutic treatments .\
BACKGROUND	However , risks for cognitive impairment may contribute to some patients ' refusal of ECT .\
METHODS	The present study examined galantamine as a pharmacological intervention to reduce cognitive adverse effects from ECT .\
METHODS	Thirty-nine inpatients diagnosed with major depressive disorder ; bipolar disorder , depressed type ; or schizoaffective disorder , depressed type and admitted for ECT were randomized to galantamine or placebo .\
METHODS	Study drugs were initiated 24 to 48 hours before starting ECT and continued throughout the course of ECT .\
METHODS	A neuropsychological test battery was administered at baseline and 24 to 48 hours after completing a course of ECT treatments .\
METHODS	Depression severity was monitored using the 17-item Hamilton Rating Scale for Depression and Clinical Global Impression Scale at baseline , weekly , and end point .\
METHODS	Self-rated adverse effects were monitored weekly .\
RESULTS	Thirty participants ( 12 patients in the galantamine group , 18 patients in the placebo group ) had both pretreatment and posttreatment neuropsychological ratings .\
RESULTS	Those in the galantamine group scored significantly higher at discharge for delayed memory ( t28 = 2.44 , P < 0.05 ) .\
RESULTS	Hierarchical regressions examined if treatment condition predicted changes in delayed memory scores from baseline to discharge .\
RESULTS	Inclusion of the treatment condition in the final model made a significant incremental improvement in prediction ( R = 0.12 , F1 ,27 change = 4.65 , P < 0.05 ; = 0.37 , t = 2.16 , P < 0.05 ) .\
RESULTS	Galantamine was well tolerated with no clinically significant bradycardia or prolonged paralysis when administered with ECT .\
CONCLUSIONS	Galantamine may be protective against impairment in retention of new learning .\
CONCLUSIONS	Galantamine exhibited minimal adverse effects and was safe when administered during ECT .\
CONCLUSIONS	The present findings require replication by future researchers using larger samples before broad conclusions can be drawn .\
\
###18637935\
OBJECTIVE	Both injectable silicone biomaterial ( PTQ ) and pyrolytic carbon-coated beads ( Durasphere ) have been shown to be effective in treating passive faecal incontinence due to internal sphincter dysfunction .\
OBJECTIVE	This is a randomized study to evaluate their relative safety and efficacy .\
METHODS	Forty patients ( mean age 59.5 years vs 58.9 years ) were randomized to have inter-sphincteric injection of PTQ or submucosal injection of Durasphere .\
METHODS	Patients were assessed with anorectal physiology , endoanal ultrasound , a validated incontinence score and quality of life questionnaires .\
RESULTS	In the Durasphere group , complications included rectal pain ( 5 % ) , erosion through rectal mucosa ( 10 % ) , and type III hypersensitivity reaction ( 5 % ) .\
RESULTS	No complications occurred in the PTQ group .\
RESULTS	Compared with PTQ , Durasphere group has a more rapid action , with improved continence at 2 weeks after injection .\
RESULTS	In both groups , faecal continence significantly improved 6 weeks after injection , and continued to improve significantly up to 6 months in both groups ( P < 0.0001 ) .\
RESULTS	At 6 weeks , 6 and 12 months after injection , significantly more PTQ patients achieved greater than 50 % improvement in Wexner 's continence score than Durasphere patients ( respectively , P = 0.01 ; P < 0.0001 ; P = 0.001 ) .\
RESULTS	There was a significant improvement in faecal incontinence quality of life scale and the 12-month physical health scale of Short Form-12 health survey in the PTQ group but not in the Durasphere group .\
CONCLUSIONS	In patients with internal sphincter dysfunction , injectable silicone biomaterial was safer and more effective than Durasphere .\
\
###11232606\
BACKGROUND	Clinical trials of treatments for paroxysmal atrial tachyarrhythmia ( pAT ) often compare different treatment groups using the time to first episode recurrence .\
BACKGROUND	This approach assumes that the time to the first recurrence is representative of all times between successive episodes in a given patient .\
BACKGROUND	We subjected this assumption to an empiric test .\
RESULTS	Records of pAT onsets from a chronologic series of 134 patients with dual chamber implantable defibrillators were analyzed ; 14 had experienced > 10 pAT episodes , which is sufficient for meaningful statistical modeling of the time intervals between episodes .\
RESULTS	Episodes were independent and randomly distributed in 9 of 14 patients , but a fit of the data to an exponential distribution , required by the stated assumption , was rejected in 13 of 14 .\
RESULTS	In contrast , a Weibull distribution yielded an adequate goodness of fit in 5 of the 9 cases with independent and randomly distributed data .\
RESULTS	Monte Carlo methods were used to determine the impact of violations of the exponential distribution assumption on clinical trials using time from cardioversion to first episode recurrence as the dependent measure .\
RESULTS	In a parallel groups design , substantial loss of power occurs with sample sizes < 500 patients per group .\
RESULTS	In a cross-over design , there is insufficient power to detect a 30 % reduction in episode frequency even with 300 patients .\
CONCLUSIONS	Clinical trials that rely on time to first episode recurrence may be considerably less able to detect efficacious treatments than may have been supposed .\
CONCLUSIONS	Analysis of multiple episode onsets recorded over time should be used to avoid this pitfall .\
\
###10526808\
OBJECTIVE	To determine if providing an Anesthesiology Consultant Report ( ACR ) to patients would result in enhanced patients ' perceptions of their knowledge about their care and improve their perception of the quality of their care .\
METHODS	Randomized , unblinded study .\
METHODS	Outpatient center associated with tertiary care center .\
METHODS	371 outpatients without adverse anesthetic events .\
METHODS	Patients were randomized to receive either routine discharge instructions or routine instructions and an anesthesia discharge summary ( ACR ) .\
RESULTS	Short questionnaire with discharge packet regarding knowledge of anesthetic and questions regarding satisfaction and perceptions of quality of care was distributed .\
RESULTS	The patients in the group that received an ACR were more satisfied with the management of their pain and other symptoms ( p < 0.05 , by Wilcoxon rank sums ) and were more satisfied overall with the quality of the anesthesia care ( p < 0.01 , by Wilcoxon rank sums ) .\
RESULTS	Taken another way , significantly more patients deemed the quality of their anesthetic care as excellent in the ACR group compared to control ( 83 % vs. 67 % , p < 0.01 ) .\
CONCLUSIONS	Providing patients , with uneventful anesthetic courses , with information regarding their anesthetic care , in the form of the ACR , results in improved perceptions of the quality of care .\
\
###18222355\
OBJECTIVE	We explored whether the benefit of intensive versus moderate statin therapy would be greater in carriers of KIF6 719Arg than in noncarriers .\
BACKGROUND	The 719Arg variant of Trp719Arg ( rs20455 ) , a polymorphism in kinesin-like protein 6 , is associated with greater risk of coronary events and greater benefit from pravastatin versus placebo .\
METHODS	We genotyped 1,778 acute coronary syndrome patients within the PROVE IT-TIMI 22 ( Pravastatin or Atorvastatin Evaluation and Infection Therapy : Thrombolysis in Myocardial Infarction 22 ) trial and investigated different intensities of statin therapy in carriers of 719Arg and in noncarriers using Cox proportional hazards models that adjusted for traditional risk factors .\
RESULTS	Benefit from intensive , compared with moderate , statin therapy was significantly greater in the 59 % of the cohort who were carriers ( hazard ratio [ HR ] 0.59 , 95 % confidence interval [ CI ] 0.45 to 0.77 ) than in those who were noncarriers ( HR 0.94 , 95 % CI 0.70 to 1.27 ; p = 0.018 for interaction between 719Arg carrier status and treatment ) .\
RESULTS	Absolute risk reduction was 10.0 % in carriers versus 0.8 % in noncarriers .\
RESULTS	The benefit of intensive therapy in carriers was significant as early as day 30 of therapy .\
RESULTS	Carriers and noncarriers did not differ in on-treatment low-density lipoprotein cholesterol , triglyceride , or C-reactive protein ( CRP ) levels .\
CONCLUSIONS	Carriers of 719Arg receive significantly greater benefit from intensive statin therapy than do noncarriers , a superior benefit that appears to be due to a mechanism distinct from lipid or CRP lowering .\
CONCLUSIONS	Functional studies of the KIF6 kinesin are warranted , given the consistent association of Trp719Arg with risk of coronary events and statin benefit .\
\
###21786577\
OBJECTIVE	Effects of levosimendan treatment compared to dopamine treatment on a clinical course , central hemodynamics and prognosis in patients with resistant cardiac failure ( RCF ) .\
METHODS	A total of 30 RCF patients ( 16 females and 14 males aged 50-80 years ) were divided into two groups .\
METHODS	Patients of group 1 received inotropic drug levosimendan intravenously in the initial dose 12-24 mcg/kgfor 10 min with subsequent 24-hour infusion in a dose 0.1 mcg/kg/min .\
METHODS	Patients of group 2 received dopamine intravenously for 24 hours in a mean dose 2.2 mcg/kg/min .\
METHODS	The patients were followed up for 6 months .\
RESULTS	In group 1 cardiac failure regressed earlier than in group 2 .\
RESULTS	Left ventricular performance index after infusion hour 1 increased from 2.9 to 3.3 ( kg.m ) / m2 , in group 2 it decreased from 2.6 to 2.3 ( kg.m ) / m2 ; p = 0.028 ) .\
RESULTS	To infusion hour 24 this index in group 1 was 3.2 ( kg.m ) / m2 , in group 2 -- 2.6 ( kg.m ) / m2 .\
RESULTS	Cardiac index ( CI ) in group 1 increased from 23 l/min/m2 at infusion min 1 to 2.7 l/min / m2 after 10 min of infusion and 29 l/min/m2 after 24 hours , i.e. there was a 26 % rise ( p = 0.025 ) .\
RESULTS	In group 2 the CI rise was insignificant -- from 2.4 to 2.5 l/min/m2 .\
RESULTS	To the end of levosimendan injection , systemic vascular resistance fell from 1520.9 to 1174.6 dyne.s.cm ( -5 ) ( p = 0.031 ) , in group 2 no significant changes were seen .\
RESULTS	Hospital mortality in group 1 was 1 patient , in group 2 -- 6 patients .\
CONCLUSIONS	Inotropic treatment in RCF patients with levosimendan vs dopamine produces earlier regress of cardiacfailure symptoms , better improvement of myocardial contractivity , is associated with a good prognosis .\
\
###18757091\
BACKGROUND	The BEAUTIFUL study assessed the morbidity and mortality benefits of the heart rate-lowering agent ivabradine .\
BACKGROUND	The placebo arm of the BEAUTIFUL trial was a large cohort of patients with stable coronary artery disease and left-ventricular dysfunction .\
BACKGROUND	We did a subanalysis of this placebo group to test the hypothesis that elevated resting heart rate at baseline is a marker for subsequent cardiovascular death and morbidity .\
METHODS	The association of baseline resting heart rate with cardiovascular outcomes was analysed using Cox proportional hazard models for groups with a heart rate of 70 beats per min ( bpm ) or greater ( 2693 patients ) versus less than 70 bpm ( 2745 patients ) .\
METHODS	Additional analyses were done with finer categorisation of heart rate , and with heart rate as a continuous variable .\
RESULTS	After adjustment for baseline characteristics , patients with heart rates of 70 bpm or greater had increased risk for cardiovascular death ( 34 % , p = 0.0041 ) , admission to hospital for heart failure ( 53 % , p < 0.0001 ) , admission to hospital for myocardial infarction ( 46 % , p = 0.0066 ) , and coronary revascularisation ( 38 % , p = 0.037 ) .\
RESULTS	For every increase of 5 bpm , there were increases in cardiovascular death ( 8 % , p = 0.0005 ) , admission to hospital for heart failure ( 16 % , p < 0.0001 ) , admission to hospital for myocardial infarction ( 7 % , p = 0.052 ) , and coronary revascularisation ( 8 % , p = 0.034 ) .\
RESULTS	The analysis of fine-groupings of heart rate suggests that the increase in mortality and heart failure outcomes rises continuously above 70 bpm , whereas the relation is less pronounced for coronary outcomes .\
RESULTS	For heart failure outcomes , the predictive value of resting heart rate was stronger for earlier events than for later events .\
CONCLUSIONS	In patients with coronary artery disease and left-ventricular systolic dysfunction , elevated heart rate ( 70 bpm or greater ) identifies those at increased risk of cardiovascular outcomes , with a differential effect on outcomes associated with heart failure and outcomes associated with coronary events .\
\
###18065583\
BACKGROUND	Reports on the dose response to vitamin D are conflicting , and most data were derived from white men and women .\
OBJECTIVE	The objective was to determine the response of serum 25-hydroxyvitamin D [ 25 ( OH ) D ] to oral vitamin D ( 3 ) supplementation in an African American population .\
METHODS	Healthy black postmenopausal women ( n = 208 ) participated in a vitamin D ( 3 ) supplementation trial for a period of 3 y. Analyses were done in the vitamin D supplementation arm ( n = 104 ) to quantify the response in serum 25-hydroxyvitamin D concentrations at a steady state vitamin D input .\
METHODS	The participants received 20 microg/d ( 800 IU ) oral vitamin D ( 3 ) for the initial 2 y and 50 microg/d ( 2000 IU ) for the third year .\
RESULTS	Supplementation with 20 microg/d ( 800 IU/d ) vitamin D ( 3 ) raised the mean serum 25 ( OH ) D concentration from a baseline of 46.9 + / - 20.6 nmol/L to 71.4 + / - 21.5 nmol/L at 3 mo. .\
RESULTS	The mean ( + / - SD ) concentration of serum 25 ( OH ) D was 87.3 + / - 27.0 nmol/L 3 mo after supplementation increased to 50 microg/d ( 2000 IU/d ) .\
RESULTS	All participants achieved a serum 25 ( OH ) D concentration > 35 nmol/L , 95 % achieved a concentration > 50 nmol/L , but only 60 % achieved a concentration > 75 nmol/L .\
RESULTS	All patients had concentrations < 153 nmol/L .\
RESULTS	On the basis of our findings , an algorithm for prescribing vitamin D so that patients reach optimal serum concentrations was developed .\
RESULTS	The algorithm suggests a dose of 70 microg ( 2800 IU/d ) for those with a concentration > 45 nmol/L and a dose of 100 microg ( 4000 IU/d ) for those with a concentration < 45 nmol/L .\
CONCLUSIONS	Supplementation with 50 microg/d ( 2000 IU/d ) oral vitamin D ( 3 ) is sufficient to raise serum 25-hydroxyvitamin D concentrations to > 50 nmol/L in almost all postmenopausal African American women .\
CONCLUSIONS	However , higher doses were needed to achieve concentrations > 75 nmol/L in many women in this population .\
\
###15938378\
BACKGROUND	The present rationale appears to prefer early postoperative enteral nutrition to total parenteral nutrition .\
BACKGROUND	But no clear conclusions exist for demonstrating the clinical benefit of early postoperative enteral nutrition in patients after the major surgical resections of upper gastrointestinal tract .\
OBJECTIVE	To compare the clinical impact of various types of the artificial nutrition by comparison of the postoperative complications .\
METHODS	Prospective , randomized , controlled clinical trial .\
METHODS	Sixty-two patients were analyzed .\
METHODS	In the group I ( 21 patients ) the total parenteral nutrition was received , in the group II ( 20 patients ) the standard enteral nutrition was received , in the group III ( 21 patients ) the enteral nutrition enriched with glutamin , arginin and omega-3 fatty acids was received .\
METHODS	Both enteral feedings were given early .\
METHODS	All three nutritional regiments were isocaloric and isoproteinaceus .\
RESULTS	The postoperative complications were in 31 patients overall ( 11 , 11 , 9 patients in the each group I , II , III ) .\
RESULTS	Three patients died in the group I , 2 patients in the group II , and 1 patient in the group III .\
RESULTS	There were no significance differences ( p < 0,05 ) in postoperative complications , both infectious and non-infectious reasons .\
CONCLUSIONS	The study has shown no impact of various type of artificial nutrition on clinical outcome in patients after major resections of upper gastrointestinal tract .\
CONCLUSIONS	There was no significant difference in infectious complications in the groups with enteral feeding .\
CONCLUSIONS	The combination of enteral and parenteral nutrition appears as optimum after major surgery of the upper gastrointestinal tract .\
CONCLUSIONS	It is necessary to realize more extensive studies of homogenous patients to find out the benefit of various types of arteficial nutrition in postoperative period .\
\
###11208997\
BACKGROUND	The influence of potassium ( K ) removal on dialysis efficiency as measured by urea elimination is not clear .\
BACKGROUND	In this prospective , randomized , cross-over study we investigated the magnitude of K removal and its effect on urea ( u ) elimination during high-flux haemodialysis ( HD ) .\
METHODS	Twelve stable , non-diabetic HD patients were investigated during three one-week standardized HD periods ( 1.8 m ( 2 ) high-flux polysulphone dialyser , treatment time 240 min , Qb = 300 ml/min , Qd = 500 ml/min , dialysate without glucose , bicarbonate 40 mmol/l ) , using dialysates containing 0 ( 0K ) , 1 ( 1K ) , and 2 ( 2K ) mmol/l of K. Mass removal of K ( M ( K ) ) and u ( M ( U ) ) were measured during the mid-week treatment by partial dialysate collection .\
METHODS	Urea reduction rate ( URR ) and Kt/V were determined .\
RESULTS	0K , 1K and 2K treatments were perfectly comparable .\
RESULTS	Plasma K ( PK ) continuously declined reaching stable concentrations after 180 min .\
RESULTS	While 0K dialysate removed 117.1 mmol , 80.2 and 63.3 mmol ( P < 0.001 ) were removed by 1K and 2K baths respectively .\
RESULTS	M ( U ) was not influenced by M ( K ) ( r = 0.22 ) and amounted to 491.1 ( 0K ) , 508.6 ( 1K ) , and 506.2 ( 2K ) mmol ( NS ) respectively .\
RESULTS	Accordingly , urea clearance , URR and Kt/V were constant during 0K , 1K and 2K treatments .\
CONCLUSIONS	Potassium-free dialysate significantly enhances potassium elimination .\
CONCLUSIONS	Potassium removal has no influence on urea elimination .\
CONCLUSIONS	High potassium removal , when needed , does not impair dialysis efficiency as measured by urea kinetics in high-flux , glucose-free , 40 mmol/l bicarbonate HD .\
\
###25344589\
OBJECTIVE	Aspirin exacerbated respiratory disease ( AERD ) is comprised of aspirin/acetylsalicylic acid ( ASA ) sensitivity , bronchial asthma , and nasal polyposis .\
OBJECTIVE	Treatment of this condition is challenging and may include topical/systemic steroids , endoscopic sinus surgery , and/or aspirin desensitization .\
METHODS	A prospective crossover pilot study ( n = 10 ) was conducted in which patients were randomized into either of 2 groups with 6 weeks of regular diet ( R ) or 6 weeks of a low salicylate diet ( LS ) .\
METHODS	The study was conducted in a tertiary otolaryngology clinic .\
METHODS	Patients with AERD were enrolled in the study .\
METHODS	Subjective ( Sino-nasal Outcome Test-22 [ SNOT-22 ] , Nasal Sinus Symptom Scale [ NSSS ] , and the Asthma Control Questionnaire-7 [ ACQ-7 ] ) and objective outcome instruments ( Peri-Operative Sinus Evaluation [ POSE ] and Lund-Kennedy Endoscopic Score [ LKES ] ) were used to evaluate patients at baseline , 6 weeks ( at crossover ) , and 12 weeks .\
RESULTS	Wilcoxon rank sum tests demonstrated that patients on the low salicylate diet had improved scores compared to their regular diet when evaluated by 4 of the 5 outcome measures ( SNOT-22 pLS = 0.0059 , NSSS pLS = 0.0195 , LKES pLS = 0.0039 , POSE pLS = 0.005 ) .\
CONCLUSIONS	Results of the pilot study indicate that implementation of a low salicylate diet improves the nasal symptoms and nasal endoscopy findings of individuals with AERD .\
CONCLUSIONS	Further research is required to support these findings .\
\
###18677171\
BACKGROUND	In cardiac rehabilitation , 40-60-min exercise training sessions are advised .\
BACKGROUND	However , because of the increasing coronary artery disease ( CAD ) prevalence and higher workload for cardiac rehabilitation centres , it remains unclear whether 40-min exercise training sessions are equally effective as 60-min exercise training sessions .\
METHODS	Prospective randomized clinical trial .\
METHODS	One hundred and thirty-four CAD patients were included in a 7-week rehabilitation programme .\
METHODS	All patients exercised 3 days per week , at a heart rate corresponding to 65 % of baseline peak oxygen uptake ( VO2peak ) .\
METHODS	Patients were randomized in two groups : 40 versus 60-min exercise training sessions .\
METHODS	Changes of body anthropometrics , resting haemodynamics , exercise capacity and ventilatory threshold , blood plasma lipid profile and C-reactive protein level were assessed .\
RESULTS	As a result of rehabilitation , exercise capacity , ventilatory threshold , and blood plasma lipid profile improved significantly in the total population ( P < 0.05 ) , without differences between subgroups ( P > 0.05 ) .\
RESULTS	Body weight and waist circumference decreased significantly in total population ( P < 0.01 ) , but with a greater magnitude in the 40 versus 60-min exercise session group ( P < 0.05 ) .\
CONCLUSIONS	In the early rehabilitation of CAD patients , 40-min exercise training sessions seem to be at least as effective for improving body anthropometrics , blood plasma lipid profile and exercise capacity , as compared with 60-min exercise training sessions .\
\
###19080512\
OBJECTIVE	To examine the effect of labor analgesia with ropivacaine on maternal serum prolactin , time of first colostrum production and the rate of abundant lactation .\
METHODS	A total of 124 women of vaginal delivery were randomly divided into labor analgesia group ( n = 75 ) and control group ( n = 49 ) .\
METHODS	Labor analgesia group received ropivacaine by patient-controlled epidural analgesia .\
METHODS	Three ml ropivacaine ( 0.125 % ) was injected through an epidural catheter and another 12 ml ropivacaine was injected 5 min later if there were no total spinal anesthesia .\
METHODS	The block level of analgesia was controlled to be below T10 level .\
METHODS	Then 5 ml ( 0.104 mg/min ) ropivacaine per hour was continuously pumped till full dilation of ostium of the uterus .\
METHODS	The control group consisted of women of normal spontaneous delivery with no pain relieving measure .\
METHODS	The prolactin levels of antepartum , postpartum 0 h , 2 h , 6 h , 12 h and 24 h were determined by microparticle chemoluminescence .\
METHODS	Starting time of lactation , the feeding times in 24 hours , the rate of abundant lactation , and neonatal weight 24 hours after delivery were recorded .\
RESULTS	( 1 ) The serum prolactin of both groups increased instantly after delivery , reached a peak 2 hours after delivery and kept high levels 24 hours after delivery .\
RESULTS	( 2 ) The prolactin levels of labor analgesia group [ ( 19.5 + / - 8.4 ) nmol/L and ( 14.5 + / - 5.6 ) nmol/L ] were lower than those of control group [ ( 22.6 + / - 7.2 ) nmol/L and ( 16.9 + / - 5.7 ) nmol/L ] 2 and 24 hours after delivery ( P < 0.05 ) .\
RESULTS	( 3 ) In labor analgesia group the starting time of lactation was within 24 hours after delivery in 73 cases ( 97 % ) , lactation amount was abundant within 48 hours in 55 cases ( 73 % ) and newborn weight reduction in the first day after delivery was ( 57 + / - 42 ) g.\
RESULTS	In control group the starting time of lactation was within 24 hours after delivery in 45 cases ( 92 % ) , lactation amount was abundant within 48 hours in 28 cases ( 57 % ) and newborn weight reduction in the first day after delivery was ( 62 + / - 40 ) g.\
RESULTS	There were no differences between the two groups in the starting time of lactation , the rate of abundant lactation , and newborn weight reduction ( P > 0.05 ) .\
CONCLUSIONS	( 1 ) Epidural anesthesia with ropivacaine might affect the secretion of prolactin , while the starting time and amount of lactation may be affected by other factors .\
CONCLUSIONS	( 2 ) Prolactin increases after delivery , reaches a peak 2 hours after delivery and maintains high levels 24 hours after delivery , which contented necessary for lactation .\
\
###10607766\
BACKGROUND	Acute renal failure following the administration of radiocontrast media ( RCM ) is a complication found especially in patients with impaired renal function .\
BACKGROUND	Within the limits of a pilot study , the objective was to ( a ) show the effectiveness and compatibility of prostaglandin E ( 1 ) ( PGE ( 1 ) = Alprostadil ) in preventing acute renal failure in patients with elevated levels of serum creatinine and ( b ) to identify the most appropriate PGE ( 1 ) - dose .\
METHODS	130 patients with renal impairment ( serum creatinine > / = 1.5 mg/dl ) were included in the study prior to intravascular RCM injection .\
METHODS	The patients received one of three different doses of PGE ( 1 ) ( 10 , 20 , or 40 ng/kg bodyweight/min ) or placebo ( physiologic sodium chloride solution ) intravenously over a time period of 6 h ( beginning 1 h prior to RCM application ) .\
METHODS	Serum creatinine was measured 12 , 24 , and 48 h post RCM-application and creatinine clearance was determined with two 12 h collection periods , as well as one 24 h collection within 48 h post RCM administration .\
METHODS	Adverse events during PGE ( 1 ) administration were recorded .\
RESULTS	In the placebo group , the mean elevation of serum creatinine was markedly higher ( 0.72 mg/dl ) 48 h after RCM administration compared with the three PGE ( 1 ) groups ( 0.3 mg/dl in the 10 ng/kg/min group , 0.12 mg in the 20 ng/kg/min group , and 0.29 mg/dl in the 40 ng/kg/min group ) .\
RESULTS	No clinically relevant changes were seen regarding the creatinine clearance in the four groups examined .\
CONCLUSIONS	Results from this pilot-study suggest that intravenous PGE ( 1 ) may be used efficaciously and safely to prevent RCM-induced renal dysfunction in patients with pre-existing impaired renal function .\
\
###24103530\
OBJECTIVE	To compare the skills of performing a vaginal breech ( VB ) delivery after hands-on training versus demonstration .\
METHODS	We randomized medical students to a 30-min demonstration ( group 1 ) or a 30-min hands-on ( group 2 ) training session using a standardized VB management algorithm on a pelvic training model .\
METHODS	Subjects were tested with a 25 item Objective Structured Assessment of Technical Skills ( OSATS ) scoring system immediately after training and 72 h thereafter .\
METHODS	OSATS scores were the primary outcome .\
METHODS	Performance time ( PT ) , self assessment ( SA ) , confidence ( CON ) , and global rating scale ( GRS ) were the secondary outcomes .\
METHODS	Statistics were performed using the Mann-Whitney U-test , chi-square test , and multiple linear regression analysis .\
RESULTS	172 subjects were randomized .\
RESULTS	OSATS scores ( primary outcome ) were significantly higher in group 2 ( n = 88 ) compared to group 1 ( n = 84 ) ( 21.182.29 vs. 20.192.37 , respectively ; p = 0.006 ) .\
RESULTS	The secondary outcomes GRS ( 10.312.28 vs. 9.172.21 ; p = 0.001 ) , PT ( 214.6057.97 s vs. 246.9859.34 s ; p < 0.0001 ) , and CON ( 3.140.89 vs. 2.850.90 ; p = 0.04 ) were also significantly different between groups , favoring group 2 .\
RESULTS	After 72 h , primary and secondary outcomes were not significantly different between groups .\
RESULTS	In a multiple linear regression analysis , group assignment ( odds ratio [ OR ] 1.60 ; 95 % confidence interval [ CI ] 1.14-2 .05 ; p < 0.0001 ) and gender ( OR 2.91 ; 95 % CI 2.45-3 .38 ; p < 0.0001 ) independently influenced OSATS scores .\
CONCLUSIONS	Hands-on training leads to a significant improvement of VB management in a pelvic training model , but this effect was only seen in the short term .\
\
###18713156\
OBJECTIVE	To assess the efficacy and safety of low-dose topiramate in migraine prophylaxis vs propranolol .\
METHODS	A randomized , double-blind , clinical trial including 62 patients with frequent migraine headaches ( > or = 3 attacks per month ) was performed for a period of 8 weeks .\
METHODS	The patients were randomly divided into two treatment groups - treated by topiramate 50 mg/day and propranolol 80 mg/day , respectively .\
METHODS	The patients were assessed at 0 , 4 , and 8 weeks of the study .\
METHODS	Results - The topiramate group showed a reduction in the mean ( + / - SD ) of monthly migraine frequency from 6.07 ( + / -1.89 ) to 1.83 ( + / -1.39 ) episodes per month , headache intensity from 7.1 ( + / -1.45 ) to 3.67 ( + / -2.1 ) based on the Visual Analog Scale , and headache duration from 16.37 ( + / -7.26 ) to 6.23 ( + / -5.22 ) hours ( P < 0.001 ) .\
METHODS	In the patients treated with propranolol , the mean ( + / - SD ) of monthly headache frequency declined from 5.83 ( + / -1.98 ) to 2.2 ( + / -1.67 ) per month , headache intensity lessened from 6.43 ( + / -1.6 ) to 4.13 ( + / -1.94 ) and headache duration decreased from 15.10 ( + / -6.84 ) to 7.27 ( + / -6.46 ) h ( P < 0.001 ) .\
CONCLUSIONS	This study demonstrated that both low-dose topiramate and propranolol could significantly reduce migraine headache frequency , intensity , and duration .\
CONCLUSIONS	However , compared with propranolol , low-dose topiramate showed better results .\
\
###12623333\
OBJECTIVE	to determine the degree of interobserver variation of color-flow duplex scanning of infrainguinal arterial bypass grafts .\
METHODS	two experienced vascular technologists randomly assessed bypass grafts in 32 consecutive patients , using a color-flow duplex scan .\
METHODS	In pre-defined segments the highest peak systolic velocity ( PSV ( max ) ) and end-diastolic velocity ( EDV ) were measured and a peak systolic velocity ratio ( PSV ratio ) was calculated .\
METHODS	Results were analyzed as continuous variables ( Bland and Altman plots and Intraclass Correlation Coefficient = ICC ) and also as categorical data ( weighted Kappa coefficient ) for the PSV ratio 1-2 .5 , > or = 2.5-4 , > or = 4.0 .\
RESULTS	the ICC for the PSV ( max ) , PSV ratio and EDV indicated `` almost perfect '' agreement for all three parameters .\
RESULTS	However , the Bland and Altman plots showed impressive interobserver variation for the higher values of all three parameters .\
RESULTS	For the PSV ratio categories a weighted kappa of 0.31 was calculated , indicating only fair agreement .\
RESULTS	Substantial variation was found for the categories with PSV ratios > or = 2.5-4 .0 and > or = 4.0 .\
CONCLUSIONS	though performing accurately for the lower values of the assessed parameters , duplex scanning shows considerable interobserver variation for the clinically significant higher values .\
CONCLUSIONS	Particularly in the PSV ratio interval > or = 2.5-4 .0 , most relevant for clinical decision-making , the interobserver variability is unacceptable .\
\
###21806837\
BACKGROUND	Osteoporosis is a growing worldwide problem , with the greatest burden resulting from fractures .\
BACKGROUND	Nevertheless , the majority of fractures in adults occur in those with `` osteopenia '' ( bone mineral density ( BMD ) only moderately lower than young normal individuals ) .\
BACKGROUND	Since long-term drug therapy is an expensive option with uncertain consequences and side effects , natural herbal therapy offers an attractive alternative .\
BACKGROUND	The purpose of this study is to evaluate the effect on BMD and safety of the Classic Yin and Yang Tonic Formula for treatment of osteopenia and to investigate the mechanism by which this efficacy is achieved .\
METHODS	We propose a multicenter double-blind randomized placebo-controlled trial to evaluate the efficacy and safety of the Classic Yin and Yang Tonic Formula for the treatment of osteopenia .\
METHODS	Participants aged 55 to 75 with low bone mineral density ( T-score between -1 and -2.5 ) and kidney deficiency in TCM will be included and randomly allocated into two groups : treatment group and control group .\
METHODS	Participants in the treatment group will be treated with Classic Yin and Yang Tonic Granule , while the controlled group will receive placebo .\
METHODS	Primary outcome measure will be BMD of the lumbar spine and proximal femur using dual-energy X-ray absorptiometry .\
METHODS	Secondary outcomes will include pain intensity measured with visual analogue scales , quality of life , serum markers of bone metabolism , indices of Neuro-endocrino-immune network and safety .\
CONCLUSIONS	If the Classic Yin and Yang Tonic Formula can increase bone mass without adverse effects , it may be a novel strategy for the treatment of osteoporosis .\
CONCLUSIONS	Furthermore , the mechanism of the Chinese medical formula for osteoporosis will be partially elucidated .\
BACKGROUND	This study is registered at ClinicalTrials.gov , NCT01271647 .\
\
###15192274\
OBJECTIVE	A high virological response rate can often be shown to be obtained with PEG-IFN alpha-2b and ribavirin combination therapy in chronic hepatitis C patients .\
OBJECTIVE	Viral dynamics have been utilized for the evaluation of antiviral effects , especially the exponential second decay slope , which represents the elimination of infected cells .\
METHODS	Forty-nine patients were randomly assigned to the IFN alpha-2b group ( n = 26 ) or the PEG-IFN alpha-2b group ( n = 23 ) .\
METHODS	Ribavirin was administered equally to both groups .\
METHODS	Measuring the serum concentration of HCVRNA , the exponential viral decay during phase 1 and 2 was calculated .\
RESULTS	The exponential decay slope in phase 2 during the first 2 weeks was greater in the IFN alpha-2b group than in the PEG-IFN alpha-2b group ; however , from weeks 3 to 4 , it was greater in the PEG-IFN alpha-2b group than in the IFN alpha-2b group .\
RESULTS	Interestingly , in the PEG-IFN alpha-2b group , the exponential decay slope was greater from weeks 3 to 4 after initiating combination therapy than during the weeks 1-2 ( p < 0.01 ) , despite administration of the same PEG-IFN alpha-2b dose ( 1.5 microg/kg once weekly ) .\
CONCLUSIONS	In PEG-IFN alpha-2b and ribavirin combination therapy , elimination of infected cells may be pronounced following an increase in serum ribavirin concentration in chronic hepatitis C patients with genotype 1b infection and a high viral load .\
\
###24127265\
BACKGROUND	Previous studies have found partners ' smoking status , multiparity , and nicotine dependence to be associated with smoking cessation in pregnancy .\
BACKGROUND	However , no studies have investigated influences on cessation among women using nicotine replacement therapy ( NRT ) .\
BACKGROUND	We analyzed data from a trial of NRT in pregnancy to determine factors associated with shorter - and longer-term cessation .\
METHODS	Data were collected at baseline , 1 month , and delivery from 1,050 pregnant women .\
METHODS	Two multivariable logistic models for validated cessation at 1 month and delivery were created with a systematic strategy for selection of included factors .\
RESULTS	All findings are from multivariable analyses .\
RESULTS	At 1 month , odds of cessation were greater among those who completed full time education at > 16 years of age ( odds ratio [ OR ] = 1.82 , 95 % confidence interval CI = 1.24-2 .67 , p = .002 ) but they were lower in women with higher baseline cotinine levels ( OR = 0.93 , 95 % CI = 0.90-0 .95 , p < .001 ) .\
RESULTS	At delivery , the odds of cessation were greater among those who completed full time education at > 16 years of age ( OR = 1.89 , 95 % CI = 1.16-3 .07 , p = 0.010 ) but were inversely associated with higher baseline cotinine levels ( OR = 0.96 , 95 % CI = 0.92-0 .99 , p = .010 ) .\
CONCLUSIONS	Women who are better educated and have lower pretreatment cotinine concentrations had higher odds of stopping smoking and factors associated with shorter and longer term cessation were similar .\
\
###15646908\
OBJECTIVE	The purpose of this study was to compare the perception of pain and time of onset in relation to mandibular alveolar nerve block administered by a computerized anesthesia delivery system ( ie , The Wand ) and a traditional anesthesia system ( ie , the syringe ) .\
METHODS	This study was conducted according to a split-mouth design , with both types of injections being given to all patients .\
METHODS	Subjects consisted of 33 patients between 7 and 18 years of age requiring local anesthesia for dental restorations in both sides of the mandible .\
METHODS	All patients were blindfolded , and the sound from the Wand machine was activated during both types of administration .\
METHODS	Topical analgesic was placed in the area of the injection site in all cases .\
METHODS	Pain ratings were obtained using a 10-point visual analog scale ( VAS ) .\
METHODS	Time of onset was measured , from withdrawal of the needle to numbness of the lower lip was reported .\
RESULTS	The computerized anesthesia delivery system resulted in significantly lower pain ratings than the traditional syringe .\
RESULTS	No difference could be found in time of onset between the 2 methods .\
CONCLUSIONS	Mandibular alveolar block analgesia seems to be less painful when using The Wand than when using a traditional syringe .\
\
###16259540\
OBJECTIVE	Escitalopram has proven efficacy in the short-term treatment of generalized social anxiety disorder ( SAD ) .\
OBJECTIVE	The present relapse prevention study investigated relapse rates during a 24-week , randomized , double-blind , placebo-controlled period in patients with generalized SAD who had responded to 12-week open-label treatment with escitalopram .\
METHODS	A total of 517 patients with a primary diagnosis of generalized SAD ( per DSM-IV criteria ) and a Liebowitz Social Anxiety Scale ( LSAS ) total score of > or = 70 received 12 weeks of open-label treatment with flexible doses ( 10-20 mg/day ) of escitalopram .\
METHODS	Of these patients , 371 responded ( Clinical Global Impressions-Improvement scale [ CGI-I ] score of 1 or 2 ) and were randomly assigned to 24 weeks of double-blind treatment with escitalo-pram ( 10 or 20 mg/day ) ( N = 190 ) or placebo ( N = 181 ) , continuing with the dose level administered at the end of the open-label period .\
METHODS	Relapse was defined as either an increase in LSAS total score of > or = 10 or withdrawal due to lack of efficacy , as judged by the investigator .\
METHODS	The study was conducted from January 2001 to June 2002 .\
RESULTS	Survival analysis of relapse and time to relapse showed a significant advantage for escitalopram compared to placebo ( log-rank test : p < .001 ) .\
RESULTS	The risk of relapse was 2.8 times higher for placebo-treated patients than for escitalopram-treated patients ( p < .001 ) , resulting in significantly fewer escitalopram-treated patients relapsing ( 22 % vs. 50 % ) , at both doses .\
RESULTS	Escitalopram was well tolerated during double-blind treatment of generalized SAD , and only 2.6 % of the escitalopram-treated patients withdrew because of adverse events .\
RESULTS	The overall discontinuation rate , excluding relapses , was 13.2 % for patients treated with escitalopram and 8.3 % for patients treated with placebo .\
CONCLUSIONS	Escitalopram was effective and well tolerated in the long-term treatment of generalized SAD .\
\
###18552044\
OBJECTIVE	was to estimate the skin microcirculation reactivity after histamine administration in patients treated with 10 mg daily dose of cetirizine for 180 days .\
METHODS	Thirty seven young men age 27 +12 year , patients suffering from persistent rhinitis were randomized into three groups which received 10 mg/day of cetirizine , 5 mg/day of levocetirizine or placebo respectively .\
METHODS	Twenty eight completed the study .\
METHODS	The skin microcirculation reaction after 10 mg/ml histamine administration was estimated visually on the forearm ( diameter of wheal and flare ) and by laser Doppler flowmetry before and after study drug or placebo administration 24 hours and every 30 days during the time of the study .\
METHODS	The blood flow was measured by Periflux PF3 , using a skin probe 5 mm away from the histamine-induced point .\
RESULTS	Statistically significant inhibition of skin reaction ( over 92 % ) and blood flow ( over 85 % ) in relation to the start values in cetirizine group as well as between the groups which received cetirizine or placebo ( p < 0.001 ) , remained at the same level all the time during the examination .\
CONCLUSIONS	Tachyphylaxis phenomenon for antihistamine effect of 10 mg/day cetirizine and 5 mg/day levocetirizine was not observed during the whole 180-days treatment .\
\
###1797506\
OBJECTIVE	To study the influence of molecular aggregation on rates of subcutaneous insulin absorption and to attempt to elucidate the mechanism of absorption of conventional soluble human insulin in humans .\
METHODS	Seven healthy male volunteers aged 22-43 yr and not receiving any drugs comprised the study .\
METHODS	This study consisted of a single-blind randomized comparison of equimolar dosages of 125I-labeled forms of soluble hexameric 2 Zn2 + human insulin and human insulin analogues with differing association states at pharmaceutical concentrations ( AspB10 , dimeric ; AspB28 , mixture of monomers and dimers ; AspB9 , GluB27 , monomeric ) .\
METHODS	After an overnight fast and a basal period of 1 h , 0.6 nmol/kg of either 125I-labeled human soluble insulin ( Actrapid HM U-100 ) or 125I-labeled analogue was injected subcutaneously on 4 separate days 1 wk apart .\
METHODS	Absorption was assessed by measurement of residual radioactivity at the injection site by external gamma-counting .\
RESULTS	The mean + / - SE initial fractional disappearance rates for the four preparations were 20.7 + / - 1.9 ( hexameric soluble human insulin ) , 44.4 + / - 2.5 ( dimeric analogue AspB10 ) , 50.6 + / - 3.9 ( analogue AspB28 ) , and 67.4 + / - 7.4 % / h ( monomeric analogue AspB9 , GluB27 ) .\
RESULTS	Absorption of the dimeric analogue was significantly faster than that of hexameric human insulin ( P less than 0.001 ) ; absorption of monomeric insulin analogue AspB9 , GluB27 was significantly faster than that of dimeric analogue AspB10 ( P less than 0.01 ) .\
RESULTS	There was an inverse linear correlation between association state and the initial fractional disappearance rates ( r = -0.98 , P less than 0.02 ) .\
RESULTS	Analysis of the disappearance data on a log linear scale showed that only the monomeric analogue had a monoexponential course throughout .\
RESULTS	Two phases in the rates of absorption were identified for the dimer and three for hexameric human insulin .\
RESULTS	The fractional disappearance rates ( % / h ) calculated by log linear regression analysis were monomer 73.3 + / - 6.8 ; dimer 44.4 + / - 2.5 from 0 to 2 h and 68.9 + / - 3.5 from 2.5 h onward ; and hexameric insulin 20.7 + / - 1.9 from 0 to 2 h , 45.6 + / - 5.0 from 2.5 to 5 h , and 70.6 + / - 6.3 from 5 h onward .\
CONCLUSIONS	Association state is a major determinant of rates of absorption of insulin and insulin analogues .\
CONCLUSIONS	The lag phase and the subsequent increasing rate of subcutaneous soluble insulin absorption can be explained by the associated state of native insulin in pharmaceutical formulation and its progressive dissociation into smaller units during the absorption process .\
\
###15107217\
BACKGROUND	Duration of hospitalization after laparoscopic cholecystectomy ( LC ) is mainly determined by temporary side effects such as pain , nausea , and vomiting .\
BACKGROUND	In this study we compared remifentanil , a short acting opioid , and sufentanil , a longer acting opioid , on their ability to reduce these postoperative effects and facilitate LC in day case surgery .\
METHODS	Seventy patients scheduled for elective LC were randomized in two groups .\
METHODS	Remifentanil was used in group 1 as part of the anesthetic protocol , sufentanil was used in group 2 .\
METHODS	After surgery , patients were asked to evaluate pain and nausea on a verbal rate scale ( VRS ) .\
METHODS	Frequency of vomiting and analgesic medication consumption was registered .\
METHODS	Time between surgery and to the start of micturition , drinking , mobilization , dressing , and discharge was recorded .\
METHODS	Patients registered their satisfaction on a VRS .\
METHODS	Details of any other adverse events throughout the study were recorded .\
RESULTS	Twenty-two patients ( 63 % ) of group 1 were treated as day cases vs. 27 ( 77 % ) in group 2 ( P = NS ) .\
RESULTS	All patients who were not discharged as day cases left the hospital one day postoperatively .\
RESULTS	Immediately after surgery , patients in group 2 reported significantly less pain .\
RESULTS	There were no other significant differences between groups .\
CONCLUSIONS	The majority of patients scheduled for LC can be safely discharged on the day of surgery .\
CONCLUSIONS	Reported satisfaction one week postoperatively was high for all patients .\
CONCLUSIONS	We found no major relevant differences between the two anesthetic protocols .\
\
###19636019\
OBJECTIVE	In selected patients with muscle-invasive bladder cancer , combined-modality therapy ( transurethral resection bladder tumor [ TURBT ] , radiation therapy , chemotherapy ) with salvage cystectomy , if necessary , can achieve survival rates similar to radical cystectomy .\
OBJECTIVE	We investigated late pelvic toxicity after chemoradiotherapy for patients treated on prospective protocols .\
METHODS	Between 1990 and 2002 , 285 eligible patients enrolled on four prospective protocols ( Radiation Therapy Oncology Group [ RTOG ] 8903 , 9506 , 9706 , 9906 ) and 157 underwent combined-modality therapy , surviving > or = 2 years from start of treatment with their bladder intact .\
METHODS	Rates of late genitourinary ( GU ) and GI toxicity were assessed using the RTOG Late Radiation Morbidity Schema , with worst toxicity grade ( scale 0 to 5 ) occurring > or = 180 days after start of consolidation therapy reported for each patient .\
METHODS	Persistence of toxicity was defined as grade 3 + toxicity not decreasing by at least one grade .\
METHODS	Logistic and Cox regression analyses were performed to evaluate relationship between clinical characteristics , frequency , and time to late grade 3 + pelvic toxicity .\
METHODS	Covariates included age , sex , stage , presence of carcinoma in situ , completeness of TURBT , and protocol .\
RESULTS	Median follow-up was 5.4 years ( range , 2.0 to 13.2 years ) .\
RESULTS	Seven percent of patients experienced late grade 3 + pelvic toxicity : 5.7 % GU and 1.9 % GI .\
RESULTS	In only one of nine patients did a grade 3 + GU toxicity persist .\
RESULTS	Notably there were no late grade 4 toxicities and no treatment-related deaths .\
RESULTS	None of the clinical variables studied predicted for late grade 3 + pelvic toxicity .\
CONCLUSIONS	Rates of significant late pelvic toxicity for patients completing combined-modality therapy for invasive bladder cancer and retaining their native bladder are low .\
\
###23713407\
BACKGROUND	Pregnancy-related low back and pelvic pain is a worldwide problem .\
BACKGROUND	A large proportion of women still experience disabling daily back pain 2 years after childbirth , resulting in major changes in activities and general well-being .\
BACKGROUND	In spite of this , the source of pain and effective treatment are uncertain .\
OBJECTIVE	To evaluate the short-term effects on function of a single corticosteroid injection treatment to the ischiadic spine in women with persistent pregnancy-related pelvic pain ( PPPP ) .\
METHODS	Thirty-six women were allocated to injection treatment with slow-release triamcinolone and lidocain or saline and lidocain , given once at the sacrospinous ligament insertion on the ischiadic spine bilaterally with follow-up at 4 weeks .\
METHODS	Outcome measures were Disability Rating Index ( DRI ) , self-rated functional health ( SF-36 ) , gait speed and endurance ( 6MWT ) , and strength and endurance of trunk muscles ( isometric trunk extensor and flexor tests ) .\
RESULTS	Women in the triamcinolone group showed significantly improved DRI ( p = 0.046 ) , 6MWT ( p = 0.016 ) , and isometric trunk extensor tests ( p = 0.004 ) , as compared with the saline group .\
RESULTS	Close co-variation was shown between improved function and reduced pain intensity .\
CONCLUSIONS	Improved function was achieved among women with PPPP after a single injection treatment with slow-release corticosteroid .\
CONCLUSIONS	The effect was positively correlated to the reduced pain intensity .\
\
###17664342\
BACKGROUND	A number of reports have been made on the muscle strength at the last follow-up after arthroscopic or open Bankart repairs .\
BACKGROUND	Few have analyzed the change over time in muscle strength and compared the changes between different operative methods .\
OBJECTIVE	Muscle strength recovers faster after arthroscopic Bankart repair than after open Bankart repair , and the final muscle strength is not different between the 2 procedures .\
METHODS	Cohort study ; Level of evidence , 2 .\
METHODS	Sixty patients with anterior shoulder instability and an isolated Bankart lesion were enrolled for this study .\
METHODS	Thirty patients underwent open Bankart repair ( open group ) , and 30 patients went through arthroscopic Bankart repair ( arthroscopic group ) .\
RESULTS	The open group demonstrated markedly weaker muscle strength during forward elevation than did the arthroscopic group up to 3 months after surgery , but the difference narrowed to about 5 % at 6 months ( P = .074 ) .\
RESULTS	At 6 months after surgery , the muscle strength of the open group measured 85.8 % + / - 11.5 % in forward elevation , 89.5 % + / - 10.3 % in external rotation , and 89.3 % + / - 13.3 % in internal rotation .\
RESULTS	The corresponding figures of the arthroscopic group were 90.6 % + / - 8.6 % , 92.1 % + / - 9.1 % , and 92.1 % + / - 11.7 % .\
RESULTS	As for external and internal rotations , the open group demonstrated markedly weaker muscle strength 6 weeks after surgery , but the differences were reduced to about 6 % and 4 % , respectively , at 3 months ( P = .092 and .163 , respectively ) .\
RESULTS	There was no statistically significant difference in final muscle strength 12 months after the operation between the 2 groups ( P = .503 , .468 , and .659 , respectively ) .\
CONCLUSIONS	Muscle strength recovered faster with an arthroscopic procedure than with an open procedure during the early postoperative periods , and strength was restored to the level of the unaffected side at 6 months postoperatively .\
CONCLUSIONS	In the group with open Bankart repairs , the muscle strength during forward elevation recovered slower than did external and internal rotation muscle strengths .\
\
###14635321\
OBJECTIVE	To test whether change in cognitive-behavioral variables ( such as self-efficacy , coping strategies , and helplessness ) is a mediator in the relation between cognitive behavior therapy and reduced pain and depression in persons with rheumatoid arthritis ( RA ) .\
METHODS	A sample of patients with RA who completed a stress management training program ( n = 47 ) was compared to a standard care control group ( n = 45 ) .\
METHODS	A path analysis testing a model including direct effects of comprehensive stress management training on pain and depression and indirect effects via change in cognitive-behavioral variables was conducted .\
RESULTS	The path coefficients for the indirect effects of stress management training on pain and depression via change in cognitive-behavioral variables were statistically significant , whereas the path coefficients for the direct effects were found not to be statistically significant .\
CONCLUSIONS	Decreases in pain and depression following stress management training are due to beneficial changes in the arenas of self-efficacy ( the belief that one can perform a specific behavior or task in the future ) , coping strategies ( an individual 's confidence in his or her ability to manage pain ) , and helplessness ( perceptions of control regarding arthritis ) .\
CONCLUSIONS	There is little evidence of additional direct effects of stress management training on pain and depression .\
\
###8909478\
BACKGROUND	Previous work has shown that parents prefer to be present when their children undergo common invasive procedures , although physicians are ambivalent about parental presence .\
OBJECTIVE	To determine the effect of a parent-focused intervention on the pain and performance of the procedure , anxiety of parents and clinicians , and parental satisfaction with care .\
METHODS	Children younger than 3 years old undergoing venipuncture , intravenous cannulation , or uretheral catheterization .\
METHODS	Pediatric emergency department of Boston City Hospital .\
METHODS	Randomized controlled trial with three groups ; parents present and given instructions on how to help their children ; parents present , but no instructions given ; and parents not present .\
METHODS	The parents were instructed to touch , talk to , and maintain eye contact during the procedure .\
RESULTS	A total of 431 parents was randomized to the intervention ( N = 153 ) , present ( N = 147 ) , and not present ( N = 131 ) groups .\
RESULTS	The groups were equivalent with respect to measured sociodemographic variables and parents ' previous experience in the pediatric emergency department .\
RESULTS	No differences emerged with respect to pain ( 3-point scale measured by parent and clinician , and analysis of cry ) ; performance of the procedure ( number of attempts , completion of procedure by first clinician , time ) ; clinician anxiety ; or parental satisfaction with care .\
RESULTS	Parents who were present were more likely to rate the pain of the children as extreme/severe ( 52 % ) in comparison to clinicians ( 15 % , kappa .07 , poor agreement ) and were significantly less anxious than parents who were not present .\
CONCLUSIONS	Overall , the intervention was not effective in reducing the pain of routine procedures .\
CONCLUSIONS	Parental presence did not negatively affect performance of the procedure or increase clinician anxiety .\
CONCLUSIONS	Parents who were present were less anxious than those who were not present .\
CONCLUSIONS	In general , parents have indicated that they want to be present when their children undergo procedures .\
CONCLUSIONS	The results of this study challenge the traditional belief that parental presence negatively affects our ability to successfully complete procedures .\
CONCLUSIONS	We should encourage parents who want to be present to stay during procedures .\
\
###23834479\
OBJECTIVE	The objective of this analysis was to compare costs of paricalcitol or cinacalcet plus low dose vitamin D , and of phosphate binders , in patients in the IMPACT SHPT study ; and to extrapolate those to estimate expected annual maintenance costs .\
METHODS	IMPACT SHPT was a 28-week , randomized , open-label trial .\
METHODS	Subjects from 12 countries received intravenous ( IV ) or oral paricalcitol , or oral cinacalcet plus fixed IV doxercalciferol or oral alfacalcidol .\
METHODS	The primary end-point was the proportion of subjects who achieved a mean intact parathyroid hormone ( iPTH ) value of 150-300pg / mL during weeks 21-28 ( evaluation period ) .\
METHODS	This study compares the costs of study drugs and phosphate binders among participants during the study and annualized .\
METHODS	This analysis includes only those subjects that reached the evaluation period ( 134 in each group ) .\
RESULTS	The mean total drug costs over the study period were 2606 ( SD = 2000 ) in the paricalcitol group and 3034 ( SD = 3006 ) in the cinacalcet group ( difference 428 , p = 0.1712 ) .\
RESULTS	The estimated annualized costs were 5387 ( SD = 4139 ) in the paricalcitol group and 6870 ( SD = 6256 ) in the cinacalcet group ( difference 1492 , p = 0.0395 ) .\
RESULTS	In addition , a significantly greater proportion ( p = 0.010 ) of subjects in the paricalcitol arm ( 56.0 % ) achieved an iPTH of 150-300pg / mL during the evaluation period compared to the cinacalcet arm ( 38.2 % ) .\
CONCLUSIONS	This was a secondary analysis of the IMPACT SHPT study which was not designed or powered for costs as an outcome .\
CONCLUSIONS	The dosing of study drugs and phosphate binders in the IMPACT study may not reflect actual practice , and patients were followed for 28 weeks , while the treatment of SHPT is long-term .\
CONCLUSIONS	Patients with SHPT requiring hemodialysis who were treated with a paricalcitol-based regimen for iPTH control had lower estimated annual drug costs compared to those treated with cinacalcet plus low-dose vitamin D.\
\
###24629504\
OBJECTIVE	This randomized controlled trial of outpatients with breast cancer ( stage I or II ) evaluated the effects of a 3-week educational intervention on patient levels of fatigue .\
METHODS	Norwegian outpatients were randomized into an intervention group ( n = 79 ) and a control group ( n = 81 ) .\
METHODS	Women with fatigue ( > 2.5 on a 0-10 numeric rating scale , NRS ) completed the Fatigue Questionnaire ( FQ ) and the Lee Fatigue Scale ( LFS ) at baseline ( after treatment ) ( T1 ) , immediately after intervention ( T2 ) and 3 months after intervention ( T3 ) .\
RESULTS	The mean fatigue score ( NRS ) at study entry was 6.1 ( SD 1.7 ) and 36 % ( n = 57 ) had a score 7 .\
RESULTS	There were no statistically significant differences between the fatigue measures of women in the intervention and control group at T2 or T3 in the overall sample after the intervention .\
RESULTS	Using an NRS cut-off of 5 , there was a borderline difference for women who scored < 5 for chronic fatigue on FQ ( p = 0.062 ) and a significant difference for energy on LFS ( p = 0.042 ) where the women in the intervention group had less fatigue .\
RESULTS	Using an NRS cut-off score of 6 , there was a borderline difference for women who scored < 6 for fatigue on FQ ( p = 0.062 ) and a significant difference for energy on LFS ( p = 0.021 ) where women in the intervention group had more energy than those in the control group .\
CONCLUSIONS	Further research is needed to identify psycho-educational interventions to reduce levels of fatigue and to tailor an intervention based on the level of fatigue .\
CONCLUSIONS	Fatigue measurements should be chosen more carefully .\
\
###9663539\
OBJECTIVE	A significant metabolic derangement occurs in the ischaemic-reperfused heart of patients undergoing coronary artery bypass surgery using cold blood cardioplegia .\
OBJECTIVE	The aim of the present study was to investigate whether this effect could be reversed by complementing cold blood cardioplegia with a short terminal exposure of warm blood hyperkalaemic cardioplegia ( ` hot shot ' ) .\
METHODS	Thirty-five patients undergoing primary elective coronary revascularisation were randomized to one of two different techniques of myocardial protection .\
METHODS	In the cold blood group ( n = 17 ) myocardial protection was induced using antegrade hyperkalaemic cold blood cardioplegic solution .\
METHODS	In the hot shot group ( n = 18 ) this was supplemented with a short exposure to hyperkalaemic warm blood cardioplegia prior to removal of the cross clamp .\
METHODS	Intracellular substrates ( ATP and amino acids ) were measured in left ventricular biopsies collected 5 min after institution of cardiopulmonary bypass , after 30 min of ischaemic arrest and 20 min after reperfusion .\
RESULTS	Biopsies taken at the end of the period of myocardial ischaemia , when compared to control , did not show any significant change in the intracellular concentration of ATP ( from 2.71 + / - 0.32 to 2.43 + / - 0.37 micromol g wet for cold blood group and from 2.6 + / - 0.3 to 2.5 + / - 0.34 micromol/g wet weight for hot shot group ) or total free intracellular amino acids pool ( from 33.0 + / - 1.4 to 30.0 + / - 1.4 micromol/g wet weight for cold blood group and from 34.0 + / - 1.4 to 34.5 + / - 2.3 micromol/g wet weight for hot shot group ) .\
RESULTS	Upon reperfusion , however , there was a significant fall in ATP ( 23.7 + / - 1.6 micromol/g wet weight amino acids , P < 0.05 ) and in amino acids ( 1.53 + / - 0.24 micromol/g wet weight , P < 0.05 ) in the group receiving only cold blood cardioplegia but not in the hot shot group ( 2.27 + / - 0.27 micromol/g wet weight ATP and 30.5 + / - 1.6 micromol/g wet weight amino acids ) .\
CONCLUSIONS	The data suggest that warm blood hyperkalaemic reperfusion hot shot prevents myocardial metabolic derangement seen during coronary artery surgery .\
\
###23116881\
OBJECTIVE	To assess efficacy and safety of sitagliptin , a dipeptidyl peptidase-4 inhibitor , in combination therapy with metformin ( 1500 mg/day ) and pioglitazone ( 30 mg/day ) in patients with type 2 diabetes ( T2DM ) with inadequate glycemic control ( hemoglobin A1c [ HbA1c ] 7.5 % and 11 % ) .\
METHODS	This placebo-controlled , double-blind study included 313 patients , mean baseline HbA1c = 8.7 % , who were randomized to receive sitagliptin 100 mg/day or placebo for 26 weeks .\
RESULTS	The addition of sitagliptin led to significant ( P < .001 ) mean changes from baseline relative to placebo in HbA1c ( -0.7 % ) , fasting plasma glucose ( -1.0 mmol/L ) , and 2-h post-meal glucose ( -2.2 mmol/L ) .\
RESULTS	In patients with baseline HbA1c 9.0 % , mean changes from baseline in HbA1c were -1.6 % and -0.8 % for the sitagliptin and placebo groups , respectively ( between-group difference -0.8 % ; P < .001 ) .\
RESULTS	The incidences of reported adverse events were generally similar between the treatment groups .\
RESULTS	Incidences of symptomatic hypoglycemia were 7/157 [ 4.5 % ] and 6/156 [ 3.8 % ] in the sitagliptin and placebo groups , respectively ( P = .786 ) .\
RESULTS	Two patients , both in the placebo group , experienced an episode of hypoglycemia that required non-medical assistance .\
CONCLUSIONS	In this 26-week study , addition of sitagliptin to combination therapy with metformin and pioglitazone improved glycemic control and was generally well tolerated .\
\
###10092916\
OBJECTIVE	To assess neurological sequelae in patients with all grades of carbon monoxide ( CO ) poisoning after treatment with hyperbaric oxygen ( HBO ) and normobaric oxygen ( NBO ) .\
METHODS	Randomised controlled double-blind trial , including an extended series of neuropsychological tests and sham treatments in a multiplace hyperbaric chamber for patients treated with NBO .\
METHODS	The multiplace hyperbaric chamber at the Alfred Hospital , a university-attached quarternary referral centre in Melbourne providing the only hyperbaric service in the State of Victoria .\
METHODS	All patients referred with CO poisoning between 1 September 1993 and 30 December 1995 , irrespective of severity of poisoning .\
METHODS	Pregnant women , children , burns victims and those refusing consent were excluded .\
METHODS	Daily 100-minute treatments with 100 % oxygen in a hyperbaric chamber -- 60 minutes at 2.8 atmospheres absolute for the HBO group and at 1.0 atmosphere absolute for the NBO group -- for three days ( or for six days for patients who were clinically abnormal or had poor neuropsychological outcome after three treatments ) .\
METHODS	Both groups received continuous high flow oxygen between treatments .\
METHODS	Neuropsychological performance at completion of treatment , and at one month where possible .\
RESULTS	More patients in the HBO group required additional treatments ( 28 % v. 15 % , P = 0.01 for all patients ; 35 % v. 13 % , P = 0.001 for severely poisoned patients ) .\
RESULTS	HBO patients had a worse outcome in the learning test at completion of treatment ( P = 0.01 for all patients ; P = 0.005 for severely poisoned patients ) and a greater number of abnormal test results at completion of treatment ( P = 0.02 for all patients ; P = 0.008 for severely poisoned patients ) .\
RESULTS	A greater percentage of severely poisoned patients in the HBO group had a poor outcome at completion of treatment ( P = 0.03 ) .\
RESULTS	Delayed neurological sequelae were restricted to HBO patients ( P = 0.03 ) .\
RESULTS	No outcome measure was worse in the NBO group .\
CONCLUSIONS	In this trial , in which both groups received high doses of oxygen , HBO therapy did not benefit , and may have worsened , the outcome .\
CONCLUSIONS	We can not recommend its use in CO poisoning .\
\
###7680374\
OBJECTIVE	An open , randomized study was performed to assess the effects of supportive pamidronate treatment on morbidity from bone metastases in breast cancer patients .\
METHODS	Eighty-one pamidronate patients and 80 control patients were monitored for a median of 18 and 21 months , respectively , for events of skeletal morbidity and the radiologic course of metastatic bone disease .\
METHODS	The oral pamidronate dose was 600 mg/d ( high dose [ HD ] ) during the earliest study years , then changed to 300 mg/d ( low dose [ LD ] ) because of gastrointestinal toxicity .\
METHODS	Twenty-nine of 81 pamidronate ( HD/LD ) patients first received 600 mg/d and were then changed to 300 mg/d ; 52 of 81 pamidronate LD patients received 300 mg/d throughout the study .\
METHODS	Tumor treatment was unrestricted .\
RESULTS	An overall intent-to-treat analysis was performed .\
RESULTS	In the pamidronate group , the occurrence of hypercalcemia , severe bone pain , and symptomatic impending fractures decreased by 65 % , 30 % , and 50 % , respectively ; event-rates of systemic treatment and radiotherapy decreased by 35 % ( P < or = .02 ) .\
RESULTS	The event-free period ( EFP ) , radiologic course of disease , and survival did not improve .\
RESULTS	Subgroup analyses suggested a dose-dependent treatment effect .\
RESULTS	Compared with their controls , in pamidronate HD/LD patients , events occurred 60 % to 90 % less frequently ( P < or = .03 ) and the EFP was prolonged ( P = .002 ) .\
RESULTS	In pamidronate LD patients , event-rates decreased by 15 % to 45 % ( P < or = .04 ) .\
RESULTS	Gastrointestinal toxicity of pamidronate caused a 23 % drop-out rate , but other cancer-associated factors seemed to contribute to this toxicity .\
CONCLUSIONS	Pamidronate treatment of breast cancer patients efficaciously reduced skeletal morbidity .\
CONCLUSIONS	The effect appeared to be dose-dependent .\
CONCLUSIONS	Further research on dose and mode of treatment is mandatory .\
\
###18785409\
OBJECTIVE	To evaluate the efficacy and safety of recombinant human granulocyte-macrophage colony stimulating factor ( rhGM-CSF ) hydrogel in wound healing in patients with deep partial thickness burn .\
METHODS	The study was a multicenter , randomized , double-blind , placebo-controlled parallel clinical trial .\
METHODS	Three hundred and twenty-one patients ( 302 cases finally fulfilled the protocol ) with deep partial thickness burn were divided into A group ( n = 200 , with treatment of rhGM-CSF hydrogel , 100 microg/10 g/100 cm2/d ) , C group ( n = 102 , with treatment of placebo ) .\
METHODS	Side-effect , systemic condition , wound healing time , wound healing rate , and total effective rate at different time points were observed .\
RESULTS	There were no obvious differences in vital signs , wound secretion , wound edge reaction , blood and urine routine , liver and kidney function between two groups ( P > 0.05 ) .\
RESULTS	No side-effect was observed .\
RESULTS	The median wound healing time was 17 days in A group , which was obviously shorter than that in C group ( 20 days , P < 0.01 ) .\
RESULTS	The mean wound healing rate in A group was 24.5 % , 70.5 % , 95.3 % , 99.6 % respectively on 8th , 14th , 20th , 28th day after treatment , which were obviously higher than that in C group ( 15.1 % , 51.4 % , 84.6 % , 97.1 % , respectively , P < 0.01 ) .\
RESULTS	The total effective rates in A group on 8th , 14th , 20th day after treatment were also higher than that in C group ( P < 0.01 ) .\
CONCLUSIONS	rhGM-CSF hydrogel can significantly accelerate wound healing in patients with deep partial thickness burn with certain safety .\
\
###15995092\
OBJECTIVE	Screening for cognitive impairment in older emergency department ( ED ) patients is recommended to ensure quality care .\
OBJECTIVE	The Mini-Mental State Examination ( MMSE ) may be too long for routine ED use .\
OBJECTIVE	Briefer alternatives include the Six-Item Screener ( SIS ) and the Mini-Cog .\
OBJECTIVE	The objective of this study was to describe the test characteristics of the SIS and the Mini-Cog compared with the MMSE when administered to older ED patients .\
METHODS	This institutional review board-approved , prospective , randomized study was performed in a university-affiliated teaching hospital ED .\
METHODS	Eligible patients were 65 years and older and able to communicate in English .\
METHODS	Patients who were unable or unwilling to perform testing , who were medically unstable , or who received medications affecting their mental status were excluded .\
METHODS	Patients were randomized to receive the SIS or the Mini-Cog by the treating emergency physician .\
METHODS	Investigators administered the MMSE 30 minutes later .\
METHODS	An SIS score of < or = 4 , the Mini-Cog 's scoring algorithm , and an MMSE score of < or = 23 defined cognitive impairment .\
RESULTS	A total of 149 of 188 approached patients were enrolled ; 74 received the SIS and 75 the Mini-Cog .\
RESULTS	Fifty-five percent were female , the average age was 75 years , and 23 % had an MMSE score of < or = 23 .\
RESULTS	The SIS had a sensitivity of 94 % ( 95 % confidence interval [ CI ] = 73 % to 100 % ) and a specificity of 86 % ( 95 % CI = 74 % to 94 % ) .\
RESULTS	The Mini-Cog had a sensitivity of 75 % ( 95 % CI = 48 % to 93 % ) and a specificity of 85 % ( 95 % CI = 73 % to 93 % ) .\
CONCLUSIONS	The SIS , using a cutoff of < or = 4 as impaired , is a promising test for ED use .\
CONCLUSIONS	It is short , easy to administer , and unobtrusive , allowing it to be easily incorporated into the initial assessment of older ED patients .\
\
###22222478\
BACKGROUND	This randomized controlled trial describes automated coadministration of propofol and remifentanil , guided by M-Entropy analysis of the electroencephalogram .\
BACKGROUND	The authors tested the hypothesis that a novel dual-loop controller with an M-Entropy monitor increases time spent within predetermined target entropy ranges .\
METHODS	Patients scheduled for elective surgery were randomly assigned in this single-blind study using a computer-generated list , to either dual-loop control using a proportional-integral-derivative controller or skilled manual control of propofol and remifentanil using target-controlled-infusion systems .\
METHODS	In each group , propofol and remifentanil administration was titrated to a state entropy target of 50 and was subsequently targeted to values between 40 and 60 .\
METHODS	The primary outcome was the global score , which included the percentage of state entropy or response entropy in the range 40-60 , the median absolute performance error and wobble .\
METHODS	Data are presented as medians [ interquartile range ] .\
RESULTS	Thirty patients assigned to the dual-loop group and 31 assigned to the manual group completed the study .\
RESULTS	The dual-loop controller was able to provide induction and maintenance for all patients .\
RESULTS	The Global Score of State Entropy was better maintained with dual-loop than manual control ( 25 [ 19-53 ] vs. 44 [ 25-110 ] , P = 0.043 ) , and state entropy was more frequently maintained in the range of 40-60 ( 80 [ 60-85 ] vs. 60 [ 35-82 ] % , P = 0.046 ) .\
RESULTS	Propofol ( 4.1 [ 2.9-4 .9 ] vs. 4.5 [ 3.4-6 .3 ] mg kg ( -1 ) h ( -1 ) ) and remifentanil ( 0.18 [ 0.13-0 .24 ] vs. 0.19 [ 0.15-0 .26 ] g kg ( -1 ) min ( -1 ) ) consumptions and the incidence of somatic side effects were similar .\
CONCLUSIONS	Intraoperative automated control of hypnosis and analgesia guided by M-Entropy is clinically feasible and more precise than skilled manual control .\
\
###20597245\
OBJECTIVE	Most airlines enforce no-smoking policies , potentially causing flight performance decrements in pilots who are smokers .\
OBJECTIVE	We tested the hypotheses that nicotine withdrawal affects aircraft pilot performance within 12 h of smoking cessation and that chewing nicotine gum leads to significant relief of these withdrawal effects .\
METHODS	There were 29 pilots , regular smokers , who were tested in a Frasca 141 flight simulator on two 13-h test days , each including three 75-min flights ( 0 hr , 6 hr , 12 hr ) in a randomized , controlled trial .\
METHODS	On the first day ( baseline ) , all pilots smoked one cigarette per hour .\
METHODS	On the second day , pilots were randomly assigned to one of four groups : ( 1 ) nicotine cigarettes ; ( 2 ) nicotine gum ; ( 3 ) placebo gum ; ( 4 ) no cigarettes/no gum .\
METHODS	Flight Summary Scores ( FSS ) were compared between groups with repeated measures ANOVAs .\
RESULTS	No statistically significant differences in overall simulator flight performance were revealed between pilots who smoked cigarettes and pilots who were not allowed to smoke cigarettes or chew nicotine gum , but there was a trend for pilots who were not allowed to smoke to perform worse .\
RESULTS	However , pilots who chewed placebo gum performed significantly worse during the 6-h ( FSS = -0.03 ) as well as during the 12-h flight ( FSS = -0.08 ) than pilots who chewed nicotine gum ( FSS = 0.15 / 0.30 , respectively ) .\
CONCLUSIONS	Results suggest that nicotine withdrawal effects can impair aircraft pilot performance within 12 h of smoking cessation and that during smoking abstinence chewing one stick of 4-mg nicotine gum per hour may lead to significantly better overall flight performance compared to chewing placebo gum .\
\
###12871005\
OBJECTIVE	The study was carried out to determine whether showing a local analgesia ( LA ) syringe to a child would influence behaviour during subsequent administration of LA , as opposed to concealing it .\
METHODS	25 children were randomly assigned to either a show ( 13 ) or no-show ( 12 ) group .\
METHODS	The children were aged 4 years and 3 months to 8 years and 9 months , mean age 7 years and 9 months .\
METHODS	One operator carried out all LA administrations .\
METHODS	The procedure and dialogue were strictly standardised .\
METHODS	Each child was filmed during LA administration .\
METHODS	Three paediatric dentists scored the video recorded behaviours , using the Frankl Behaviour Rating Scale .\
METHODS	The raters were blind as to which group the child belonged to .\
RESULTS	No statistical difference was found between the behaviour ratings of the no-show and the show groups during LA administration ( p > 0.05 ) .\
CONCLUSIONS	Overall , the behaviour of the children in the show group did not differ from the behaviour of children in the no-show group .\
CONCLUSIONS	Whether to show or not to show the LA syringe is probably dependent on the behavioural skills of the operator .\
\
###8874372\
BACKGROUND	The literature contains few data examining the results of therapy with second-generation sulfonylurea drugs in subjects with non-insulin-dependent diabetes mellitus ( NIDDM ) after the onset of secondary failure to first-generation agents .\
BACKGROUND	The present study was undertaken to assess the efficacy of therapy with second-generation sulfonylurea in subjects with NIDDM following secondary failure to first-generation agents .\
METHODS	The study included 55 subjects with NIDDM who manifested secondary failure to first-generation sulfonylurea therapy .\
METHODS	Of these , 29 subjects underwent therapy with the second-generation sulfonylurea glipizide , and 26 subjects were treated with glyburide , both drugs administered in the maximum daily dosage .\
METHODS	Before initiation of the second-generation sulfonylurea agents and again at the end of 6 months , metabolic control was assessed by determination of fasting plasma glucose , glycosylated hemoglobin ( HbA1c ) , and the lipid profile .\
RESULTS	Fasting plasma glucose and HbA1c levels were 209 + / - 31 mg/dL and 12.3 + / - 2.1 % , respectively , before initiation of glipizide , and did not significantly change following therapy ( fasting plasma glucose , 211 + / - 34 mg/dL ; HbA1c , 11.7 + / - 1.8 % ) .\
RESULTS	Similarly , no significant alteration was noted in these metabolic values in the glyburide group ( before glyburide therapy , fasting plasma glucose , 180 + / - 16 mg/dL ; HbA1c , 11.2 + / - 1.6 % ; after glyburide therapy , fasting plasma glucose , 184 + / - 20 mg/dL ; HbA1c , 11.0 + / - 1.5 % ) .\
RESULTS	Lipids also were not significantly altered following therapy with either glipizide or glyburide .\
RESULTS	Finally , for all subjects , fasting plasma glucose and HbA1c were 200 + / - 27 mg/dL and 11.9 + / - 2.0 % , respectively , during treatment with first-generation drugs and did not change significantly following therapy with the second-generation agents ( fasting plasma glucose , 205 + / - 20 mg/dL ; HbA1c , 11.2 + / - 1.2 % ) .\
RESULTS	P values were > .60 for all comparisons .\
CONCLUSIONS	Treatment with second-generation sulfonylurea agents for patients with NIDDM following onset of secondary failure to first-generation sulfonylurea drugs achieves no better metabolic control than treatment with first-generation agents .\
\
###10604887\
BACKGROUND	Cardiopulmonary bypass ( CPB ) induces a systemic inflammatory response that causes substantial clinical morbidity .\
BACKGROUND	Activation of complement during CPB contributes significantly to this inflammatory process .\
BACKGROUND	We examined the capability of a novel therapeutic complement inhibitor to prevent pathological complement activation and tissue injury in patients undergoing CPB .\
RESULTS	A humanized , recombinant , single-chain antibody specific for human C5 , h5G1.1-scFv , was intravenously administered in 1 of 4 doses ranging from 0.2 to 2.0 mg/kg before CPB .\
RESULTS	h5G1.1-scFv was found to be safe and well tolerated .\
RESULTS	Pharmacokinetic analysis revealed a sustained half-life from 7.0 to 14.5 hours .\
RESULTS	Pharmacodynamic analysis demonstrated significant dose-dependent inhibition of complement hemolytic activity for up to 14 hours at 2 mg/kg .\
RESULTS	The generation of proinflammatory complement byproducts ( sC5b-9 ) was effectively inhibited in a dose-dependent fashion .\
RESULTS	Leukocyte activation , as measured by surface expression of CD11b , was reduced ( P < 0.05 ) in patients who received 1 and 2 mg/kg .\
RESULTS	There was a 40 % reduction in myocardial injury ( creatine kinase-MB release , P = 0.05 ) in patients who received 2 mg/kg .\
RESULTS	Sequential Mini-Mental State Examinations ( MMSE ) demonstrated an 80 % reduction in new cognitive deficits ( P < 0.05 ) in patients treated with 2 mg/kg .\
RESULTS	Finally , there was a 1-U reduction in postoperative blood loss ( P < 0.05 ) in patients who received 1 or 2 mg/kg .\
CONCLUSIONS	A single-chain antibody specific for human C5 is a safe and effective inhibitor of pathological complement activation in patients undergoing CPB .\
CONCLUSIONS	In addition to significantly reducing sC5b-9 formation and leukocyte CD11b expression , C5 inhibition significantly attenuates postoperative myocardial injury , cognitive deficits , and blood loss .\
CONCLUSIONS	These data suggest that C5 inhibition may represent a novel therapeutic strategy for preventing complement-mediated inflammation and tissue injury .\
\
###9695723\
BACKGROUND	Transdermal nicotine in doses up to 21 mg/24 hr is used to facilitate smoking cessation .\
BACKGROUND	However , this dose does not achieve the nicotine plasma levels seen among heavy smokers , and underdosing may be one of the reasons for the limited efficacy of transdermal nicotine .\
BACKGROUND	There are some concerns about the adverse cardiovascular effects of nicotine , especially with concomitant smoking .\
BACKGROUND	Treatment with higher doses of transdermal nicotine has been proposed for highly dependent smokers , but the effects of such treatment on the cardiovascular system have not been determined .\
BACKGROUND	The objective of this study was to determine the cardiovascular effects of high-dose transdermal nicotine with concomitant smoking .\
METHODS	Twelve healthy male smokers received three doses of transdermal nicotine ( 21 , 42 , and 63 mg/24 hr ) and placebo , each for 5 days , in a balanced order .\
METHODS	The subjects smoked during the first 4 days of each treatment and abstained from smoking during the fifth day .\
METHODS	Ambulatory 24-hour daytime and nighttime heart rate and blood pressure values were determined for each treatment ; plasma nicotine , cotinine , and carboxyhemoglobin levels and urinary catecholamines with aldosterone were measured on days 4 and 5 .\
METHODS	The data were compared by means of repeated-measures ANOVA .\
RESULTS	There was no difference in heart rate or blood pressure and no changes in the pattern of circadian variations with various transdermal nicotine doses compared with smoking alone , consistent with the development of tolerance .\
RESULTS	Urinary epinephrine level was significantly higher ( p < 0.05 ) with transdermal nicotine compared with no nicotine but was not higher with transdermal nicotine and smoking compared with smoking alone .\
RESULTS	No change was found in fibrinogen and lipid profiles with different nicotine doses .\
CONCLUSIONS	High-dose nicotine treatment , even with concomitant smoking , caused no short-term adverse effects on the cardiovascular system .\
\
###18650630\
OBJECTIVE	Immunomodulating nutrition is supposed to reduce the number of complications and lengthen of hospital stay during the postoperative period in patients after major gastrointestinal surgery .\
OBJECTIVE	The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients .\
METHODS	Between June 1 , 2001 , and December 31 , 2005 , a group of 214 well-nourished patients was initially assessed ( 150 men , 64 women , mean age 61.2 years ) to participate in the study .\
METHODS	Nine patients were subsequently excluded and the remaining 205 subjects were randomly assigned in a 2 x 2 factorial design into 4 study groups , ie , standard enteral nutrition ( n = 53 ) , immunomodulating enteral nutrition ( n = 52 ) , standard parenteral nutrition ( n = 49 ) , and immunomodulating enteral nutrition ( n = 51 ) .\
METHODS	The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications after upper gastrointestinal surgery ; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates , and hospital stay .\
METHODS	The study was registered in the Clinical Trials Database-number NCT 00558155 .\
RESULTS	The overall morbidity rate was 33 % and the incidence of individual complications was comparable between all groups .\
RESULTS	Infectious complications occurred in 26 of 102 patients given standard diets and in 22 of 103 patients receiving immunomodulatory formulas ( odds ratio 0.81 ; 95 % CI , 0.43-1 .50 ) .\
RESULTS	There were no significant differences between infectious complications in patients using parenteral nutrition ( 22 of 100 patients ) and parenteral formulas ( 26 of 105 , odds ratio 1.14 ; 95 % CI , 0.61-2 .14 ) .\
RESULTS	Neither immunostimulating formulas nor enteral feeding significantly affected secondary outcome measures , including overall morbidity and mortality rates , and hospital stay .\
CONCLUSIONS	Our study failed to demonstrate any clear advantage of routine postoperative immunonutrition in patients undergoing elective upper gastrointestinal surgery .\
CONCLUSIONS	Both enteral and parenteral treatment options showed similar efficacy , tolerance , and effects on protein synthesis .\
CONCLUSIONS	Parenteral nutrition composed according to contemporary rules showed similar efficiency to enteral nutrition .\
CONCLUSIONS	However , because of its cost-efficiency , enteral therapy should be considered as the treatment of choice in all patients requiring nutritional therapy .\
\
###16848802\
BACKGROUND	It has been suggested that patients with Barrett 's esophagus ( BE ) are unusually resistant to the antisecretory effects of proton pump inhibitors ( PPIs ) .\
OBJECTIVE	To compare intragastric and intraesophageal acidity in patients with BE receiving esomeprazole 40 mg three times daily ( t.i.d. ) , esomeprazole 40 mg twice daily ( b.i.d. ) , and esomeprazole 20 mg t.i.d.\
METHODS	In this randomized , double-blind , three-way crossover study , patients with long-segment BE received each of the three esomeprazole dosages for 5 days separated by 10-14-day washout periods .\
METHODS	Intragastric and intraesophageal pHs were measured for 24 h on day 5 .\
RESULTS	Among 31 patients with evaluable pH data , intragastric pH was > 4.0 for 88.4 % , 81.4 % , and 80.4 % of day 5 after treatment with esomeprazole 40 mg t.i.d. , 40 mg b.i.d. , and 20 mg t.i.d. , respectively .\
RESULTS	Esomeprazole 40 mg t.i.d. was significantly more effective than the other dosages ( p < 0.01 ) .\
RESULTS	Intraesophageal pH was < 4.0 for mean values of < 5 % of the monitoring period with all the three dosing regimens , but esophageal pH remained < 4.0 for > 5 % of the time in 16 % , 23 % , and 19 % of patients receiving esomeprazole 40 mg t.i.d. , 40 mg b.i.d. , and 20 mg t.i.d. , respectively .\
RESULTS	All dosages were well tolerated .\
CONCLUSIONS	All the three esomeprazole dosages significantly decreased intragastric acidity and reduced esophageal acid exposure to mean normal values in the total group of patients with BE .\
CONCLUSIONS	However , abnormal esophageal acid exposure continued in 16-23 % of patients despite the significant decrease in gastric acidity .\
CONCLUSIONS	These results suggest that the apparent `` PPI resistance '' described in patients with BE may be caused by their profound reflux diathesis rather than by gastric resistance to the antisecretory effects of PPIs .\
\
###19853700\
BACKGROUND	Current practice related to the management of atrial fibrillation ( AF ) complicating coronary artery bypass grafting ( CABG ) is uncertain .\
METHODS	We examined management of post-CABG AF in the PREVENT-IV trial , and we explored patterns of use of postoperative rhythm versus rate control and anticoagulation for AF by geographic region and type of site .\
METHODS	We also compared outcomes of patients who developed post-CABG AF ( 663 ) with those who did not ( 2,131 ) .\
RESULTS	The incidence of AF was 24 % .\
RESULTS	Post-CABG AF was treated with a rhythm control strategy in 81 % of patients and with warfarin in 23 % of patients .\
RESULTS	Although there were significant variations across sites in the management of post-CABG AF , patterns of use of postoperative rhythm versus rate control and anticoagulation did not differ by geographic region or by whether or not the enrolling site was an academic institution .\
RESULTS	Mortality was higher in patients with post-CABG AF than patients without AF at 30 days ( 1.5 % vs 0.7 % , P = .01 ) but not at 3 years ( 6.9 % vs 4.9 % , P = .41 ) .\
RESULTS	There was a trend toward a higher risk of mortality or stroke at 30 days in patients with AF ( 2.4 % vs 1.9 % , P = .08 ) .\
CONCLUSIONS	Although a rhythm control strategy was used in most of the patients in this trial and the overall rate of use of warfarin was low , the significance of these findings is uncertain because of the lack of data from randomized clinical trials .\
CONCLUSIONS	The substantial variations in the management of post-CABG AF across sites are likely because of definitive data on the most effective therapies , highlighting the need for clinical trials on rate versus rhythm control and on anticoagulation for AF in this setting .\
\
###22728482\
OBJECTIVE	We aimed to compare the cumulative efficacy and resistance of ADV monotherapy , ADV add-on LAM ( ADV + LAM ) , ADV and ETV ( ADV + ETV ) combination therapy in LAM-resistant patients .\
METHODS	Ninety-one adult CHB patients with LAM-resistance mutations ( YMDD ) were identified .\
METHODS	Of these 91 , 29 patients were treated with ADV monotherapy , 30 were treated with ADV + LAM and 32 were treated with ADV + ETV combination therapy , for at least 24 months .\
RESULTS	The mean serum HBV-DNA decreases from baseline at 3 , 6 , 12 , and 24 months were -3.23 , -4.41 , -5.32 , and -5.58 log ( 10 ) IU/mL in the ADV + ETV combination therapy groups , respectively ; the most significant among the three treatment groups ( p < 0.01 ) .\
RESULTS	The rate of HBV-DNA PCR undetectability ( < 60 IU/mL ) at 6 months in ADV + ETV combination therapy was 78.1 % ; also the most significant among the three treatment groups ( p = 0.024 ) .\
RESULTS	Viral breakthrough and genotypic mutations were detected in 8 ( 27.6 % ) and 4 ( 13.3 % ) patients in the ADV monotherapy and ADV+LAM therapy groups , respectively ; whereas no case of viral breakthrough and genotypic resistance was detected in the ADV+ETV combination therapy group after 24 months ( p < 0.05 ) .\
CONCLUSIONS	ADV + ETV combination therapy demonstrated faster and significantly greater suppression of HBV DNA compared with ADV add-on LAM combination therapy for patients with LAM-resistance mutations .\
CONCLUSIONS	ADV + ETV was superior to ADV + LAM in achieving initial virological response and long-term suppression activity against HBV .\
CONCLUSIONS	ADV + ETV combination therapy was the most effective to refrain from selecting HBV strains with cross-resistance to three NAs ( LAM , ADV and ETV ) for LAM-resistance patients .\
\
###11779610\
OBJECTIVE	To test the hypothesis that , in couples with unexplained infertility , tubal flushing with an oil-soluble media ( lipiodol ) would increase the pregnancy rate within 6 months compared with expectant management .\
METHODS	A prospective , randomized , controlled study in which couples were allocated to either a single treatment with lipiodol or no further action .\
METHODS	Two tertiary referral centers for assisted reproduction .\
METHODS	Couples with a diagnosis of primary or secondary unexplained infertility based on a normal semen analysis according to World Health Organization criteria , patent fallopian tubes at hysterosalpingography or laparoscopy , and ovulatory menstrual cycles based on midluteal phase progesterone levels or ultrasonic follicle tracking .\
METHODS	In those patients randomized to lipiodol , a single treatment was performed .\
METHODS	Biochemical ( i.e. , positive pregnancy test ) and clinical ( i.e. , fetal heart on ultrasound scan ) pregnancy rates .\
RESULTS	Seventeen couples were randomized to lipiodol and 17 to expectant treatment .\
RESULTS	The higher pregnancy rate after lipiodol was statistically significant .\
RESULTS	There were no complications after lipiodol treatment .\
CONCLUSIONS	There was a statistically significantly higher pregnancy rate in couples with unexplained infertility randomized to a single tubal flush with lipiodol compared with no treatment .\
\
###17229894\
BACKGROUND	Hypertriglyceridemia is a risk factor for coronary artery disease ( CAD ) .\
BACKGROUND	The American Heart Association recommends 1000 mg of omega-3 fatty acids , docosahexaenoic acid ( DHA ) and eicosapentaenoic acid ( EPA ) , daily for cardioprotection and higher doses for triglyceride-lowering in patients with CAD .\
METHODS	This was a prospective , randomized , double-blind study comparing DHA to DHA + EPA in patients with CAD and triglycerides greater than 200 mg/dL .\
METHODS	Subjects were randomized to either 1000 mg of DHA or 1252 mg of DHA + EPA for eight weeks .\
METHODS	Baseline and eight-week laboratories were drawn to assess changes in the fasting lipid profile .\
METHODS	The primary objective was to evaluate the change in triglycerides between the two groups at eight weeks .\
RESULTS	A total of 116 subjects were enrolled ; 57 in the DHA group and 59 in the DHA + EPA group .\
RESULTS	Baseline characteristics were similar between groups .\
RESULTS	The mean age was 69.4 + / - 9.1 years and 70.7 % were male .\
RESULTS	Triglycerides decreased by an average of 21.8 % in the DHA group ( p < 0.001 ) and 18.3 % in the DHA + EPA group ( p < 0.001 ) .\
RESULTS	The difference between groups was not significant .\
RESULTS	A greater proportion of subjects in the DHA group achieved triglyceride goal ( less than 150 mg/dL ) compared to the DHA + EPA group ( 24.6 % versus 10.2 % , p < 0.05 ) .\
CONCLUSIONS	Our results indicate that the American Heart Association recommended cardioprotective dose of omega-3 fatty acids can also significantly lower triglycerides in patients with CAD .\
CONCLUSIONS	There do not appear to be significant differences in triglyceride-lowering between DHA only and DHA + EPA combination products when dosing is based on DHA .\
\
###18705632\
BACKGROUND	Rosacea is a disease of complex pathogenesis and variable response to various therapeutic methods .\
BACKGROUND	Aim of the work To evaluate and compare the efficacy , safety and side effects of some topical lines of treatment of rosacea .\
METHODS	The study included 24 patients ( 23 females and 1 male ) with rosacea on the face .\
METHODS	They were classified into three groups -- each including eight patients ( 16 face sides ) -- and treated with one of three topical agents ( azelaic acid 20 % cream , metronidazole 0.75 % cream or permethrin 5 % cream ) on one side of the face and another one on the other side twice daily for 15 weeks .\
RESULTS	There was a significant improvement of lesions after 15 weeks of topical treatment with the three agents .\
RESULTS	Azelaic acid cream was significantly more effective on inflammatory lesions but not erythema than the other two creams .\
RESULTS	Side effects -- mostly transient -- were observed with topical creams with no significant difference .\
RESULTS	They included itching , burning sensation , oedema and scales .\
RESULTS	Patients who used azelaic acid 20 % cream were more satisfied than with other modalities .\
CONCLUSIONS	Azelaic acid 20 % cream provides an effective and safe alternative to metronidazole 0.75 % cream or permethrin 5 % cream with the added benefit of increased patient satisfaction .\
\
###24742662\
OBJECTIVE	To compare two self-titration algorithms for initiating and escalating prandial insulin lispro in patients with type 2 diabetes inadequately controlled on basal insulin .\
METHODS	The trial was designed as two independent , multinational , parallel , open-label studies ( A and B ) , identical in design , to provide substantial evidence of efficacy and safety in endocrine and generalist settings .\
METHODS	Subjects were 18-85 years old ( study A : N = 528 ; study B : N = 578 ) , on basal insulin plus oral antidiabetic drugs for 3 months , and had an HbA1c 7.0 % to 12.0 % ( > 53.0 to 107.7 mmol/mol ) .\
METHODS	Once optimized on insulin glargine , subjects were randomized to one of two self-titration algorithm groups adjusting lispro either every day ( Q1D ) or every 3 days ( Q3D ) for 24 weeks .\
METHODS	The primary outcome was the change in HbA1c from baseline .\
METHODS	The primary and secondary objectives were evaluated for the overall population and subjects 65 years old .\
RESULTS	Baseline HbA1c was similar ( study A : Q1D 8.3 % [ 67.2 mmol/mol ] vs. Q3D 8.4 % [ 68.3 mmol/mol ] , P = 0.453 ; study B : Q1D 8.3 % [ 67.2 mmol/mol ] vs. Q3D 8.4 % [ 68.3 mmol/mol ] , P = 0.162 ) .\
RESULTS	Both algorithms had significant and equivalent reductions in HbA1c from baseline ( study A : Q3D -0.96 % [ -10.49 mmol/mol ] , Q1D -1.00 % [ -10.93 mmol/mol ] , Q3D-Q1D 0.04 % [ 0.44 mmol/mol ] [ 95 % CI -0.15 to 0.22 ( -1.64 to 2.40 ) ] ; study B : Q3D -0.92 % [ -10.06 mmol/mol ] , Q1D -0.98 % [ -10.71 mmol/mol ] , Q3D-Q1D 0.06 % [ 0.66 mmol/mol ] [ 95 % CI -0.12 to 0.24 ( -1.31 to 2.62 ) ] ) .\
RESULTS	The incidence and rate of hypoglycemia were similar for Q3D and Q1D in both studies .\
RESULTS	In general , no clinically relevant differences were found between the two algorithms in subjects 65 years old in either study .\
CONCLUSIONS	Prandial insulin lispro can effectively and safely be initiated , by either of two self-titrated algorithms , in a variety of practice settings .\
\
###9382964\
OBJECTIVE	Glucocorticoid treatment increases urea excretion and leads to negative nitrogen balance .\
OBJECTIVE	This effect is presumed mainly to reflect actions on tissue protein metabolism , but has been shown in rats to involve an hepatic element in the form of upregulation of the kinetics of ureagenesis .\
OBJECTIVE	Likewise , the anabolic action of growth hormone administration has been shown to involve an hepatic element , just as growth hormone administration has been shown to prevent the protein catabolic side effects of prednisolone .\
OBJECTIVE	Whether glucocorticoids increase the ability of the liver to convert amino-N to urea-N in man , and whether growth hormone counteracts any possible effect of glucocorticoid has not been studied .\
METHODS	We measured urea nitrogen synthesis rates and blood alpha-amino-N levels before , during , and after a 4-h constant i.v. infusion of alanine ( 2 mmol x kg BW ( -1 ) x h ( -1 ) ) .\
METHODS	The urea nitrogen synthesis rate was estimated hourly as urinary excretion corrected for gut hydrolysis and accumulation in body water .\
METHODS	The slope of the linear relationship between urea nitrogen synthesis rate and amino-N concentration represents the hepatic kinetics of conversion of amino - to urea-N , and is denoted the functional hepatic nitrogen clearance .\
METHODS	Eight normal male subjects ( aged 22-28 years ; BMI 21.6-26 .3 kg/m2 ) were randomly studied four times : i ) after 4 days of s.c. saline injections , ii ) after 4 days of s.c. growth hormone injections ( 0.1 IU x kg ( -1 ) x day ( -1 ) ) , iii ) after 4 days of glucocorticoid administration ( 50 mg/d ) and iv ) after 4 days of growth hormone and glucocorticoid administration .\
METHODS	All injections were given at 20 00 hours and 25 mg prednisolone was given morning and evening .\
RESULTS	Growth hormone decreased functional hepatic nitrogen clearance ( l/h ) by 21 % ( from 38.8 + / -1.8 l/h ( control ) to 30.5 + / -2.7 l/h ( 4 d growth hormone ) ( mean + / - SE ) ( ANOVA ; p < 0.05 ) ) .\
RESULTS	Glucocorticoid increased functional hepatic nitrogen clearance by 23 % ( 47.7 + / -3.3 l/h , p < 0.05 ) , while growth hormone plus glucocorticoid offset any effect on functional hepatic nitrogen clearance ( 36.2 + / -3.3 l/h , p = 0.83 ) .\
CONCLUSIONS	Glucocorticoid administration leads to loss of nitrogen as urea , in part due to a specific hepatic mechanism , as shown by the increased functional hepatic nitrogen clearance .\
CONCLUSIONS	Growth hormone has the opposite effect , and also neutralises the glucocorticoid effect when given together with prednisolone .\
CONCLUSIONS	This adds to the understanding of the development and treatment possibilities of steroid catabolism .\
\
###24195862\
BACKGROUND	Knee osteoarthritis ( OA ) is a major cause of disability as well as a burden on healthcare resources .\
BACKGROUND	Tai chi has been proposed as an alternative and complementary treatment for the management of knee osteoarthritis , but there appears to be no consensus on its usefulness .\
BACKGROUND	This study aims to develop an innovative tai chi rehabilitation program ( ITCRP ) for patients with knee OA , and to investigate the effect of ITCRP intervention on a range of outcomes including pain , function , balance , neuromuscular response , and biomechanics in knee OA .\
METHODS	We will conduct a prospective , single-blind , randomized controlled trial of 140 individuals with symptomatic knee OA .\
METHODS	Patients will be randomly assigned into either an ITCRP group or a control group .\
METHODS	The ITCRP group will participate in tai chi two or three times a week for 6 months .\
METHODS	The control group will receive health education .\
METHODS	After the 6-month intervention period , there will be a 6-month follow-up period with no active intervention in either group .\
METHODS	The primary and secondary outcomes will be assessed at baseline , 6 months , and 12 months .\
METHODS	Primary outcome measures will be a visual analog scale for pain , the Western Ontario and McMaster Universities Osteoarthritis Index , and the Lequesne Knee Score .\
METHODS	The secondary outcome measures will include the Berg balance scale , knee and ankle proprioception , neuromuscular response , and 3D functional biomechanics .\
METHODS	Furthermore , adverse events will be recorded and analyzed .\
METHODS	If any participants withdraw from the trial , intention-to-treat analysiswill be performed .\
CONCLUSIONS	Important features of this trial include the randomization procedures , large sample size , and a standardized protocol for ITCRP for knee OA .\
CONCLUSIONS	This study aims to determine the feasibility of ITCRP for knee OA and provide data on the effects of ITCRP .\
CONCLUSIONS	Hence , our results will be useful for patients with knee OA as well as for medical staff and healthcare decision makers .\
BACKGROUND	Chinese Clinical Trial Registry : ChiCTR-TRC-13003264 .\
\
###16782489\
BACKGROUND	Laboratory services play an important part in screening , diagnosis , and management of patients within primary care .\
BACKGROUND	However , unnecessary use of laboratory tests is increasing .\
BACKGROUND	Our aim was to assess the effect of two interventions on the number of laboratory tests requested by primary-care physicians .\
METHODS	We did a cluster randomised controlled trial using a 2x2 factorial design , involving 85 primary-care practices ( 370 family practitioners ) that request all laboratory tests from one regional centre .\
METHODS	The interventions were quarterly feedback of practice requesting rates for nine laboratory tests , enhanced with educational messages , and brief educational reminder messages added to the test result reports for nine laboratory tests .\
METHODS	The primary outcome was the number of targeted tests requested by primary-care practices during the 12 months of the intervention .\
METHODS	This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN06490422 .\
RESULTS	Practices that received either or both the enhanced feedback and the reminder messages were significantly less likely than the control group to request the targeted tests in total ( enhanced feedback odds ratio 0.87 , 95 % CI 0.81-0 .94 ; reminder messages 0.89 , 0.83-0 .93 ) .\
RESULTS	The effect of the interventions varied across the targeted tests individually , although the number of tests requested for both interventions was generally reduced .\
RESULTS	Neither intervention was consistently better than the other .\
CONCLUSIONS	Enhanced feedback of requesting rates and brief educational reminder messages , alone and in combination , are effective strategies for reducing test requesting in primary care .\
CONCLUSIONS	Both strategies are feasible within most laboratory settings .\
\
###9448831\
OBJECTIVE	To determine whether ceftiofur sodium would be useful for treatment of acute interdigital phlegmon ( foot rot ) in cattle .\
METHODS	Randomized controlled trial .\
METHODS	308 cross-bred yearling steers with clinical signs of acute interdigital phlegmon ( i.e. , lameness with interdigital swelling , interdigital lesions , or both ) .\
METHODS	Steers were randomly assigned to 1 of 3 treatment groups : ceftiofur at a dosage of 0.1 mg/kg ( 0.045 mg/lb ) of body weight , IM , every 24 hours ; ceftiofur at a dosage of 1.0 mg/kg ( 0.45 mg/lb ) , IM , every 24 hours , and oxytetracycline at a dosage of 6.6 mg/kg ( 3 mg/lb ) , IM , every 24 hours .\
METHODS	All animals were treated for 3 days ; treatment was considered successful if animals were no longer lame on day 4 .\
METHODS	Biopsy specimens were collected prior to treatment from 5 animals in each group and submitted for anaerobic bacterial culture and histologic examination .\
RESULTS	Success rates for the high-dosage ceftiofur ( 94/129 ; 73 % ) and oxytetracycline ( 87/128 ; 68 % ) groups were significantly higher than that for the low-dosage ceftiofur group ( 5/50 ; 10 % ) , but there were no significant differences between the high-dosage ceftiofur and oxytetracycline groups .\
RESULTS	Anaerobic bacteria most frequently isolated from biopsy specimens were Porphyromonas levii and Provetella intermedia .\
CONCLUSIONS	Use of ceftiofur at a dosage of 1.0 mg/kg for treatment of cattle with acute interdigital phlegmon was as effective as use of oxytetracycline at a dosage of 6.6 mg/kg .\
CONCLUSIONS	However , ceftiofur has a negligible withdrawal time and , therefore , may be a better choice for treatment of near-market weight animals .\
\
###17764477\
OBJECTIVE	To develop a population-based model to describe and predict the pharmacokinetics of carboxyhaemoglobin ( COHb ) in adult smokers .\
METHODS	Data from smokers of different conventional cigarettes ( CC ) in three open-label , randomized studies were analysed using NONMEM ( version V , Level 1.1 ) .\
METHODS	COHb concentrations were determined at baseline for two cigarettes [ Federal Trade Commission ( FTC ) tar 11 mg ; CC1 , or FTC tar 6 mg ; CC2 ] .\
METHODS	On day 1 , subjects were randomized to continue smoking their original cigarettes , switch to a different cigarette ( FTC tar 1 mg ; CC3 ) , or stop smoking .\
METHODS	COHb concentrations were measured at baseline and on days 3 and 8 after randomization .\
METHODS	Each cigarette was treated as a unit dose assuming a linear relationship between the number of cigarettes smoked and measured COHb percent saturation .\
METHODS	Model building used standard methods .\
METHODS	Model performance was evaluated using nonparametric bootstrapping and predictive checks .\
RESULTS	The data were described by a two-compartment model with zero-order input and first-order elimination with endogenous COHb .\
RESULTS	Model parameters included elimination rate constant ( k ( 10 ) ) , central volume of distribution ( Vc/F ) , rate constants between central and peripheral compartments ( k ( 12 ) and k ( 21 ) ) , baseline COHb concentrations ( c0 ) , and relative fraction of carbon monoxide absorbed ( F1 ) .\
RESULTS	The median ( range ) COHb half-lives were 1.6 h ( 0.680-2 .76 ) and 30.9 h ( 7.13-367 ) ( alpha and beta phases , respectively ) .\
RESULTS	F1 increased with increasing cigarette tar content and age , whereas k ( 12 ) increased with ideal body weight .\
CONCLUSIONS	A robust model was developed to predict COHb concentrations in adult smokers and to determine optimum COHb sampling times in future studies .\
\
###11846205\
BACKGROUND	Various materials have been used immediately following tooth extraction to fill and/or cover the socket in an attempt to limit or prevent ridge resorption .\
BACKGROUND	The purpose of the present pilot study was to establish a reliable model to investigate the effect of various bone graft and bone replacement materials on extraction socket healing .\
BACKGROUND	This study also compared healing extraction sockets 6 to 8 months postimplantation of a bioactive glass ( BG ) or demineralized freeze-dried bone allograft ( DFDBA ) to an unfilled socket control ( C ) .\
METHODS	Following tooth extraction , a total of 30 sockets in 19 patients were randomly divided into 3 treatment groups : 10 sockets received BG , 10 sockets DFDBA , and 10 sockets served as unfilled controls .\
METHODS	Primary coverage was achieved by flap advancement over each socket .\
METHODS	Six to 8 months postextraction at time of implant placement , histological cores of the treatment sites were obtained .\
METHODS	These cores were processed , undecalcified sections prepared and stained with Stevenel blue/van Gieson 's picric fuchsin , and histomorphometrically analyzed .\
METHODS	Vital bone , connective tissue and marrow , and residual graft particles were reported as a percentage of the total core .\
RESULTS	A model system was described in humans and used to evaluate the healing response in the 3 treatment groups .\
RESULTS	Results concluded that mean vital bone present was 59.5 % for BG - , 34.7 % for DFDBA - , and 32.4 % for C-treated sites .\
RESULTS	These differences were not statistically significant .\
RESULTS	However , the residual implant material was significantly higher in DFDBA-treated ( 13.5 % ) versus BG-treated sockets ( 5.5 % ) .\
CONCLUSIONS	Although the differences in percent vital bone were not statistically significant among the 3 treatment groups in this pilot study , BG material was observed to act as an osteoconductive material which had a positive effect on socket healing at 6 to 8 months postextraction .\
CONCLUSIONS	Further research following implant placement in treated and control sockets is warranted to determine if bone implant contact is improved in BG-filled versus unfilled sockets .\
\
###12525509\
OBJECTIVE	This article describes baseline data collection and the intervention design of Partnership for Health , a smoking cessation intervention for smokers in the Childhood Cancer Survivors Study .\
OBJECTIVE	The purpose of this article is to evaluate demographic , psychosocial , and cancer-related factors that are associated with smoking behavior and mediators of smoking cessation .\
METHODS	This study includes 796 smokers from the Childhood Cancer Survivors Study database who were diagnosed with cancer before the age of 21 , had survived at least 5 years , and were at least 18 years of age at the time of the baseline survey .\
METHODS	Correlates of smoking behaviors included smoking rate , number of recent quit attempts , and nicotine dependence ; two key mediators of smoking cessation , readiness to quit smoking and self-efficacy , were also assessed .\
RESULTS	Participants smoked , on average , 14 cigarettes/day ; 53.2 % were nicotine dependent , and 58 % had made at least one quit attempt in the past year .\
RESULTS	Smoking behaviors were primarily associated with demographic variables ; mediators of cessation were primarily associated with age at cancer diagnosis and perceived vulnerability to smoking-related illnesses .\
RESULTS	Severity of psychologic symptoms was associated with increased smoking rate , high nicotine dependence , and low self-efficacy .\
RESULTS	Support for quitting was related to smoking rate , number of quit attempts , readiness to quit smoking , and self-efficacy .\
CONCLUSIONS	These findings indicate that many cancer survivors who smoke are receptive to smoking cessation interventions .\
CONCLUSIONS	Factors related to mediators of smoking cessation might be particularly good targets for intervention .\
\
###19565559\
OBJECTIVE	To evaluate the efficacy and safety of intraarticular infliximab compared with intraarticular methylprednisolone in patients with gonarthritis .\
METHODS	In 23 patients with recurrent gonarthritis despite previous intraarticular corticosteroid therapy , a total of 41 intraarticular injections ( 20 infliximab and 21 methylprednisolone ) were performed in 28 knees .\
METHODS	Initial therapy was randomly assigned , and crossover therapy was eligible within 3 months .\
METHODS	The clinical effect was assessed during 6 months of followup .\
METHODS	The primary outcome was event-free survival , defined as the time after treatment until local retreatment was performed and/or nonimprovement of the knee joint score .\
METHODS	Adverse effects were recorded during followup .\
RESULTS	All patients treated with intraarticular infliximab had an insufficient response .\
RESULTS	In contrast , 8 of the 21 intraarticular methylprednisolone injections were effective ( P = 0.004 ) .\
RESULTS	Between groups , no differences in the patients ' age , disease duration , number of disease-modifying antirheumatic drugs , or previous intraarticular methylprednisolone were observed .\
RESULTS	Reported adverse effects were not related to therapy .\
CONCLUSIONS	Treatment with intraarticular infliximab injection was not effective in patients with a chronically inflamed knee joint .\
CONCLUSIONS	Intraarticular injection with methylprednisolone was superior despite previous intraarticular corticosteroid therapy .\
CONCLUSIONS	Further investigation is needed to provide these patients with a better alternative .\
\
###15963082\
BACKGROUND	Famotidine increases Helicobacter pylori-eradication rates by a triple lansoprazole/amoxicillin/clarithromycin therapy in patients with the rapid extensive metabolizer genotype of CYP2C19 .\
OBJECTIVE	To determine the effect of famotidine on the gastric acid inhibition by lansoprazole in relation to CYP2C19 genotypes .\
METHODS	Twenty healthy volunteers with different CYP2C19 genotypes -- consisting of six rapid extensive metabolizers , nine intermediate metabolizers and five poor metabolizers -- underwent three 7-day courses with placebo , lansoprazole 30 mg twice daily , and lansoprazole 30 mg twice plus famotidine 20 mg twice daily .\
METHODS	Lansoprazole was dosed after breakfast and dinner .\
METHODS	Famotidine was dosed after lunch and at bedtime .\
METHODS	Intragastric pH monitoring was performed for 24 h on day 7 of each course .\
RESULTS	With placebo , no difference was observed in intragastric pH profiles among the three CYP2C19 genotype groups .\
RESULTS	With lansoprazole 30 mg twice daily , the median of 24-h intragastric pH in poor metabolizers ( 6.1 ) was significantly higher than those of rapid extensive metabolizers ( 4.5 ) and intermediate metabolizers ( 5.0 ) , respectively ( P = 0.0176 and 0.0388 ) , whereas with lansoprazole 30 mg twice and famotidine 20 mg twice daily , the medians were 5.4 , 5.7 , and 6.1 , respectively ( not significant ) .\
CONCLUSIONS	Acid inhibition by lansoprazole was influenced by CYP2C19 genotype status .\
CONCLUSIONS	This influence was offset by the concomitant use of famotidine .\
\
###19216763\
BACKGROUND	Patients with Chronic Tension Type Headache ( CTTH ) report functional and emotional impairments ( loss of workdays , sleep disturbances , emotional well-being ) and are at risk for overuse of medication .\
BACKGROUND	Manual therapy may improve symptoms through mobilisation of the spine , correction of posture , and training of cervical muscles.We present the design of a randomised clinical trial ( RCT ) evaluating the effectiveness of manual therapy ( MT ) compared to usual care by the general practitioner ( GP ) in patients with CTTH .\
METHODS	Patients are eligible for participation if they present in general practice with CTTH according to the classification of the International Headache Society ( IHS ) .\
METHODS	Participants are randomised to either usual GP care according to the national Dutch general practice guidelines for headache , or manual therapy , consisting of mobilisations ( high - and low velocity techniques ) , exercise therapy for the cervical and thoracic spine and postural correction .\
METHODS	The primary outcome measures are the number of headache days and use of medication .\
METHODS	Secondary outcome measures are severity of headache , functional status , sickness absence , use of other healthcare resources , active cervical range of motion , algometry , endurance of the neckflexor muscles and head posture .\
METHODS	Follow-up assessments are conducted after 8 and 26 weeks .\
CONCLUSIONS	This is a pragmatic trial in which interventions are offered as they are carried out in everyday practice .\
CONCLUSIONS	This increases generalisability of results , but blinding of patients , GPs and therapists is not possible.The results of this trial will contribute to clinical decision making of the GP regarding referral to manual therapy in patients with chronic tension headache .\
\
###21693699\
BACKGROUND	Ezetimibe , a first-in-its-class inhibitor of cholesterol absorption , is an effective agent for combined use with statins to achieve low-density lipoprotein cholesterol ( LDL-C ) goals .\
BACKGROUND	Ezetimibe in combination with simvastatin as a single-tablet formulation has proven to be highly effective in reducing serum LDL-C through the dual inhibition of cholesterol absorption and biosynthesis .\
BACKGROUND	The effect of time of administration on efficacy of this combination therapy has not been evaluated .\
OBJECTIVE	To compare the effects of morning versus evening administration of ezetimibe/simvastatin on serum cholesterol levels of patients with primary hypercholesterolemia .\
METHODS	In this multicenter , open-label , randomized , 2-sequence , 2-period crossover study , patients with primary hypercholesterolemia randomly received ezetimibe/simvastatin 10 mg/20 mg once daily , either in the morning ( within 1 hour of breakfast ) or in the evening ( within 1 hour of dinner ) for 6 weeks .\
RESULTS	Data on 171 patients ( 87 in the morning administration group and 84 in the evening administration group ) were analyzed .\
RESULTS	A significant reduction ( p 0.001 ) in the total cholesterol , triglyceride , high-density lipoprotein cholesterol , LDL-C , apo-lipoprotein B , and high-sensitivity C-reactive protein ( hs-CRP ) from baseline was achieved after each treatment .\
RESULTS	Noninferiority of morning administration versus evening administration was shown in the percentage reduction of the LDL-C level from baseline ( difference , -1.62 % ; 90 % CI -4.94 to 1.70 ) .\
RESULTS	No significant difference was found between groups with respect to the percentage of changes in other lipid parameters from baseline .\
RESULTS	Furthermore , there was no significant difference in the percentage of change in hs-CRP as an antiinflammatory marker between the morning and evening administration groups .\
RESULTS	The frequency of adverse events was similar between groups .\
CONCLUSIONS	Morning administration of ezetimibe/simvastatin 10 mg/20 mg is noninferior to evening administration with respect to LDL-C-lowering ability .\
\
###7982173\
BACKGROUND	The preoperative intratumoral injection with OK-432 ( Picibanil , Chugai Pharmaceutical Co. , Tokyo , Japan ) , an immunomodulatory agent prepared from an attenuated strain of streptococcus pyogenes , activates the regional immune system and causes degeneration of cancer tissue in carcinoma of the stomach .\
METHODS	A multi-institutional randomized trial of OK-432 to determine its clinical usefulness was conducted .\
METHODS	Three hundred and ninety-five patients with gastric cancer were assigned randomly either to receive or not to receive a preoperative intratumoral injection of OK-432 .\
METHODS	Among them , 277 patients with advanced cancer were treated by common postoperative chemoimmunotherapy consisting of mitomycin C , tegafur , and OK-432 .\
METHODS	All patients were followed for at least 5 years .\
RESULTS	The adverse effects of OK-432 injected intratumorally predominantly were mild fever , anorexia , and abdominal pain , however , no treatment was required for these symptoms .\
RESULTS	Overall , there were no differences in outcome between the OK-432 and control groups .\
RESULTS	However , analysis based on stage showed that a preoperative intratumoral injection of OK-432 significantly improved the 5-year survival rate of patients with Stage III cancer ( P = 0.0229 ) , at 47.7 % for the OK-432 group and 27.5 % for the control group .\
RESULTS	In subset analysis , when the 5-year survival of patients with and without tumor infiltrating lymphocytes ( TIL ) was compared , OK-432 injected intratumorally had a significant positive effect on the group showing a moderate to marked number of TIL ( P = 0.0438 ) .\
CONCLUSIONS	These results showed that the intratumoral injection of OK-432 may improve survival of patients with Stage III gastric cancer .\
CONCLUSIONS	Cancer 1994 ; 3097-3103 .\
\
###23032585\
BACKGROUND	Subacromial injection of a local anesthetic is used to eliminate pain as a confounding factor in clinical assessment of abduction strength in shoulders with a suspected rotator cuff tear .\
BACKGROUND	If strength remains diminished despite pain relief , a rotator cuff tear is likely .\
BACKGROUND	The effect of injecting local anesthetic into the subacromial space on the strength of a normal shoulder is unknown , although it could affect strength by impairing suprascapular or axillary nerve function .\
BACKGROUND	We hypothesized that subacromial injection of a local anesthetic could decrease shoulder abduction and/or external rotation strength , resulting in physical examination findings that could mislead the clinician .\
METHODS	A double-blinded , randomized , placebo-controlled design was used to evaluate the effect of subacromial injection of lidocaine on shoulder strength in ten healthy male volunteers .\
METHODS	The contralateral shoulder served as the placebo control for each treated shoulder .\
METHODS	Abduction and external rotation strength measurements and electromyographic assessment were performed before and after the subacromial injection .\
METHODS	Ultrasonography was used to verify the integrity of the rotator cuff and to document the distribution pattern of the injected local anesthetic .\
RESULTS	The injection was subacromial in eighteen ( 90 % ) of twenty shoulders .\
RESULTS	There was no significant difference in pain or electromyographic parameters between shoulders injected with lidocaine and those injected with 0.9 % saline solution ( p > 0.05 ) .\
RESULTS	In the Whipple position , placebo injection into the subacromial space decreased strength significantly compared with the pre-injection state ( 95 17 to 84 20 N , p = 0.012 ) , whereas a similar decrease observed in the lidocaine group did not reach significance ( 97 15 to 87 14 N , p = 0.092 ) .\
RESULTS	In 90 of abduction in the scapular plane ( supraspinatus test position ) , there was no significant decrease in strength in either group .\
CONCLUSIONS	Subacromial injection reached the subacromial bursa in most cases ( 90 % ) without radiographic guidance .\
CONCLUSIONS	The injection of a local anesthetic into the subacromial bursa had no relevant effect on shoulder strength and did not falsify the clinical assessment of strength .\
METHODS	Diagnostic Level I. See Instructions for Authors for a complete description of levels of evidence .\
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###20795797\
BACKGROUND	Physician-patient communication skills help determine the nature and quality of diagnostic information elicited from patients , the quality of the physician 's counseling , and the patient 's adherence to treatment .\
BACKGROUND	In spite of their importance , surveys have demonstrated a wide variability and deficiencies in the teaching of these skills .\
OBJECTIVE	Describe two specific methodologies for teaching physician-patient communication skills developed at our institution and pilot test them for effectiveness .\
METHODS	Between 2004 and 2009 we developed `` doc.com , '' a series of 41 media-rich online modules on all aspects of healthcare communication jointly with the American Academy on Communication in Healthcare .\
METHODS	Starting in 2006 , we expanded our pre-existing experience with the videoconferencing system `` WebOSCE '' into the online application `` WebEncounter . ''\
METHODS	This new methodology combines practice of communication skills on standardized patients with structured assessment and constructive feedback .\
METHODS	We had three randomized groups : controls who did only the assessment parts of a WebOSCE on two occasions , a doc.com group who had doc.com in between the assessment occasions , and a combined group that had both doc.com and a WebEncounter between assessments .\
CONCLUSIONS	We found significant improvement in skills as components were added , and the training program was well received .\
\
###14750614\
BACKGROUND	Telithromycin , a new ketolide , exhibits potent activity against respiratory pathogens , including resistant strains .\
METHODS	Five days of telithromycin ( 800 mg once daily ) was compared with 10 days of cefuroxime axetil ( 250 mg twice daily ) in subjects ( n = 593 ) with acute bacterial maxillary sinusitis ( ABMS ) .\
METHODS	Bacteriologic sampling was accomplished by sinus puncture or nasal endoscopy .\
METHODS	The primary efficacy variable was clinical outcome at the posttherapy/test-of-cure evaluation in clinically evaluable patients .\
RESULTS	Clinical cure was achieved in 85.2 % of telithromycin patients and 82.0 % of cefuroxime axetil patients ( difference in proportions , 3.2 % ; 95 % confidence interval , -7.1 -13.4 % ) .\
RESULTS	Satisfactory bacteriologic response rates were comparable .\
RESULTS	Treatment-emergent adverse events for both drugs were mild or moderate .\
RESULTS	The most frequently reported treatment-emergent adverse events were nausea and diarrhea .\
CONCLUSIONS	Once-daily telithromycin for 5 days was equivalent in efficacy to twice-daily cefuroxime axetil for 10 days in patients with ABMS .\
CONCLUSIONS	Telithromycin is a suitable option for short-course therapy of ABMS .\
\
###20002082\
BACKGROUND	* The importance of efficient drug development using biomarkers has been increasingly emphasized , from preclinical studies to clinical trials .\
BACKGROUND	* However , as yet few validated or qualified biomarkers are used in early-stage drug development in terms of clinical pharmacology and disease pathophysiology .\
CONCLUSIONS	* This first-time-in-human study provides evidence of the pharmacological activity of LC15-0444 in humans , by using dipeptidyl peptidase IV activity and active glucagon-like peptide-1 concentrations .\
CONCLUSIONS	* LC15-0444 possesses pharmacokinetic and pharmacodynamic characteristics that support a once-daily dosing regimen .\
OBJECTIVE	LC15-0444 is a selective and competitive inhibitor of dipeptidyl peptidase ( DPP ) IV with potential for the treatment of Type 2 diabetes .\
OBJECTIVE	The aim was to investigate the pharmacokinetic ( PK ) and pharmacodynamic ( PD ) profiles after multiple oral ascending doses of LC15-0444 in healthy male subjects .\
METHODS	A dose block-randomized , double-blind , placebo-controlled , parallel group study was performed in three groups with 10 subjects ( eight for active drug ; two for placebo ) per group ; each group received 200 , 400 or 600 mg of LC15-0444 once daily for 10 days .\
METHODS	Blood and urine samples were collected up to 24 h after the first dosing and up to 72 h after the last dosing .\
RESULTS	The LC15-0444 concentration-time profiles exhibited characteristics of multicompartment disposition .\
RESULTS	No dose - or time-dependent change in PK parameters was observed .\
RESULTS	Mean elimination half-life was in a range 16.6-20 .1 h in the dose groups .\
RESULTS	Mean renal clearance and fraction of unchanged drug excreted in urine was 18.6-21 .9 and 0.40-0 .48 l h ( -1 ) , respectively .\
RESULTS	In the steady state , mean accumulation ratios by dose groups were between 1.22 and 1.31 .\
RESULTS	More than 80 % inhibition of DPP IV activity from baseline was sustained for > 24 h in all dose groups .\
CONCLUSIONS	This study provides evidence of the pharmacological activity of LC15-0444 in humans .\
CONCLUSIONS	LC15-0444 possesses PK and PD characteristics that support a once-daily dosing regimen .\
\
###22637363\
OBJECTIVE	The objective of the present study was to investigate the effect of a 12-week randomised controlled cycling-to-school trial on cardiorespiratory fitness .\
METHODS	A total of 53 10 - to 13-year-old children from one public school were included .\
METHODS	The children were randomised into either a cycling group or a control group .\
METHODS	The cycling group was encouraged to cycle to and from school each day during a period of 12 weeks .\
METHODS	Peak oxygen consumption ( VO ( 2peak ) ) and anthropometrical data ( weight and height ) were measured at baseline and at the end of the 12-week period .\
RESULTS	No significant differences were observed in VO ( 2peak ) change over the 12-week period between the cycling group and the control group ( 49.7 ml O ( 2 ) / min/kg vs. 50.6 ml O ( 2 ) / min/kg ; effect size = -0.13 , F = 0.495 , p = 0.486 ) .\
RESULTS	Within the intervention group , 69.2 % ( 95 % CI 50.1-88 .2 ) started cycling , and within the control group 40.8 % ( 95 % CI 20.9-60 .5 ) started cycling .\
RESULTS	Given that several children in both groups ( intervention and control ) started cycling to school , re-analyses were conducted between those starting cycling and those not starting cycling .\
RESULTS	At follow up , a significant difference between those starting cycling and those who did not starting cycling was observed in VO ( 2peak ) ( 51.7 ml O ( 2 ) / min/kg vs. 47.9 ml O ( 2 ) / min/kg ; effect size = 0.49 , F = 8.145 , p = 0.007 ) , after adjustment for baseline scores , gender and age .\
CONCLUSIONS	This study indicates that cycling to school improves cardiorespiratory fitness .\
\
###15975304\
OBJECTIVE	To evaluate the efficacy of Breviscapine on essential hypertension ( EH ) patients complicated with micro-albuminuria of renal impairment .\
METHODS	Seventy-six EH patients were randomly assigned to the control group and the treated group , the former was given amlodipine , captopril/uropidil and the latter was given in addition Breviscapine intravenously dripped for 2 treatment courses .\
METHODS	The indexes of serum creatinine ( Cr ) , blood urea nitrogen ( BUN ) , blood and urinary beta ( 2 ) - microglobulin ( beta ( 2 ) - MG ) , and quantitative determination of 24 hrs urinary protein were evaluated before and after treatment .\
RESULTS	In the control group , compared with before treatment , the quantitative determination of 24 hrs urinary protein got reduced significantly ( P < 0.05 ) , while in the treated group , both urinary beta ( 2 ) - MG and quantitative determination of 24 hrs urinary protein got lowered significantly ( P < 0.05 and P < 0.01 ) .\
RESULTS	But after treatment , compared with the control group , urinary beta ( 2 ) - MG and quantitative determination of 24 hrs urinary protein in the treated group were obviously reduced ( P < 0.05 ) .\
CONCLUSIONS	Besides lowering blood pressure effectively , Breviscapine could improve the renal function significantly and reduce the urinary micro-albuminuria , hence showing promising effect on renal protection .\
\
###23255691\
OBJECTIVE	To evaluate the effect of the second dose of measles vaccine on measles antibody status during childhood .\
METHODS	Immunization centre of Under-five Clinic of the Department of Community Medicine at a tertiary-hospital .\
METHODS	Randomized Controlled trial .\
METHODS	Children from 6 years to 17 year old .\
METHODS	188 with simple obesity , and 431 with obesity and metabolic abnormalities .\
METHODS	274 age and gender-matched healthy children as controls .\
METHODS	Blood samples were collected from all subjects for baseline measles serology by heel puncture at 9-12 months of age .\
METHODS	All subjects were given the first dose of measels vaccine .\
METHODS	At second visit ( 3-5 months later ) , after collecting the blood sample from all , half the children were randomized to receive the second dose of measles vaccine ( study group ) , followed by collection of the third sample six weeks later in all the subjects .\
RESULTS	A total of 78 children were enrolled and 30 children in each group could be analyzed .\
RESULTS	11 ( 36.6 % ) children in the study group and 13 ( 43.3 % ) children in the control group had protective levels of measles IgG at baseline .\
RESULTS	Around 93.3 % of children in the study group had protective measles antibody titers as against 50 % in the control group at the end of the trial .\
RESULTS	The Geometric Mean Titre ( GMT ) of measles IgG increased from 14.8 NTU/mL to 18.2 NTU/mL from baseline to six weeks following receipt of the second dose of the vaccine in the study group , as compared to a decrease from 16.8 NTU/mL to 12.8 NTU/mL in the control group .\
CONCLUSIONS	A second dose of measles vaccine boosts the measles antibody status in the study population as compared to those who receive only a single dose .\
\
###12114432\
OBJECTIVE	Overexpression of the excision repair cross-complementing 1 ( ERCC1 ) gene , which is crucial in the repair of cisplatin ( CDDP ) - DNA adducts , is reported to negatively influence the effectiveness of CDDP-based therapy for gastric and ovarian cancers .\
OBJECTIVE	Recent evidence indicates that Gemcitabine ( Gem ) may modulate ERCC1 nucleotide excision repair activity , and down-regulation of DNA repair activity by ERCC1 antisense RNA reportedly inhibits synergism of CDDP/Gem .\
OBJECTIVE	We investigated whether ERCC1 mRNA expression levels were associated with clinical outcomes after treatment with a combination Gem/CDDP regimen for patients with advanced stage non-small cell lung cancer ( NSCLC ) .\
METHODS	Response and survival were correlated with the level of ERCC1 expression in 56 patients with advanced ( stage IIIb or IV ) NSCLC treated as part of a multicenter randomized trial with Gem 1250 mg/m ( 2 ) days 1 and 8 plus CDDP 100 mg/m ( 2 ) on day 1 every 3 weeks .\
METHODS	mRNA was isolated from paraffin-embedded pretreatment primary tumor specimens , and relative expression levels of ERCC1/beta-actin were measured using a quantitative reverse transcription-PCR ( Taqman ) system .\
RESULTS	ERCC1 expression was detectable in all tumors .\
RESULTS	There were no significant differences in ERCC1 levels by gender , age , performance status , weight loss , or tumor stage .\
RESULTS	The overall response rate was 44.7 % .\
RESULTS	There were no significant associations between ERCC1 expression and response .\
RESULTS	Median overall survival was significantly longer in patients with low ERCC1 expression tumors ( 61.6 weeks ; 95 % confidence interval , 42.4-80 .7 weeks ) compared to patients with high expression tumors ( 20.4 weeks , 95 % confidence interval , 6.9-33 .9 weeks ) .\
RESULTS	ERCC1 expression , Eastern Cooperative Oncology Group performance status , and presence of weight loss were significant prognostic factors for survival in a Cox proportional hazards multivariable analysis .\
CONCLUSIONS	These data suggest that ERCC1 expression is a predictive factor for survival after CDDP/Gem therapy in advanced NSCLC .\
CONCLUSIONS	Although there was a trend toward decreased response with high ERCC1 mRNA levels , this difference failed to reach statistical significance .\
CONCLUSIONS	This result may reflect the impact of Gem and the requirement for ERCC1 expression for CDDP/Gem synergism or may be attributable to the relatively small patient sample size in this study .\
CONCLUSIONS	Prospective studies of ERCC1 as a predictive marker for activity of CDDP-based regimens in NSCLC are warranted .\
\
###15899687\
OBJECTIVE	To evaluate bupropion SR for smoking cessation in physicians and nurses .\
METHODS	This double-blind prospective 26-center , 12-country trial randomized 687 subjects to smoking cessation counselling with bupropion SR or placebo for 7 weeks .\
METHODS	The participants were followed for 52 weeks .\
RESULTS	Bupropion SR was superior to placebo ( 50 % vs 40 % , P = 0.013 ) on the 4-week primary outcome variable .\
RESULTS	Due to a high placebo response in this health care population , statistical differences were not maintained after treatment was discontinued .\
CONCLUSIONS	Bupropion SR is effective and well tolerated in health care professionals .\
CONCLUSIONS	Relapse prevention measures are needed to attain long-term abstinence .\
\
###24922046\
BACKGROUND	Carotid artery stenting ( CAS ) is a worldwide diffuse intervention , but may be associated with distal plaque component embolization , and sometimes major and minor stroke .\
BACKGROUND	Statin use has been demonstrated to reduce atherosclerotic plaque burden , but its effect in reducing distal embolization during carotid stenting has not yet been well validated .\
OBJECTIVE	With the Rosuvastatin Pretreatment to Reduce Embolization during Carotid Artery Stenting trial , we aim to discover if a pretreatement with high doses of rosuvastatin in dyslipidemic patients is able to reduce periprocedural cerebral ischemic complications following carotid stenting .\
METHODS	This is a phase III prospective , randomized controlled trial .\
METHODS	All consecutive patients with asymptomatic carotid stenosis at least 80 % will be randomized to a 6-week rosuvastatin treatment followed by carotid stenting , and to direct carotid stenting .\
METHODS	Carotid stenting will be performed following common practice with distal or proximal embolic protection .\
METHODS	The primary efficacy end point of the trial will be the prevalence of ` relevant ' embolization during CAS , as a surrogate end point for cerebral ischemic complications .\
METHODS	Other laboratory and clinical data will be registered and patients will be followed up to 1 year .\
METHODS	In order to obtain the expected superiority of statin pretreatment on primary end point , a population of 130 patients will be enrolled into the study .\
CONCLUSIONS	In conclusion , with the Rosuvastatin Pretreatment to Reduce Embolization during Carotid Artery Stenting trial , we want to evaluate whether a high dose of rosuvastatin for 6 weeks before CAS in asymptomatic patients with severe carotid stenosis is able to reduce the rate of plaque embolization during the procedure , thus suggesting a possible reduction in cerebral ischemic complications .\
\
###20858829\
OBJECTIVE	The purpose of this study was to evaluate the effects of noise index and contrast material dose on radiation dose , contrast enhancement , image noise , and image quality in abdominal CT. .\
METHODS	Contrast-enhanced abdominal CT with tube current modulation was performed on 195 patients .\
METHODS	The patients were prospectively randomized into three groups of equal size ( protocol A , noise index of 12 HU and 521 mg I/kg ; protocol B , 15 HU and 521 mg I/kg ; protocol C , 15 HU and 600 mg I/kg ) .\
METHODS	Scanning was initiated 5 and 45 seconds after aortic enhancement reached 100 HU .\
METHODS	Attenuation was measured in the aorta , portal vein , and liver .\
METHODS	Transverse CT images were qualitatively graded for diagnostic acceptability and image noise .\
METHODS	Arterial phase volume-rendered and multiplanar reformatted ( MPR ) images and portal venous phase MPR CT angiograms were qualitatively graded for depiction of vessels .\
METHODS	Contrast enhancement , objective image noise , radiation dose , and qualitative grades were analyzed and compared among the three groups .\
RESULTS	The contrast enhancement values of the aorta , portal vein , and liver were higher in protocol C than in protocols A and B ( p < 0.05 ) .\
RESULTS	Objective image noise was greater in protocols B and C than in protocol A ( p < 0.05 ) .\
RESULTS	The radiation dose in protocols B and C was 31-32 % lower than in protocol A ( p < 0.001 ) .\
RESULTS	Depiction of vessels , diagnostic acceptability , and subjective image noise were comparable in protocols A and C.\
CONCLUSIONS	Use of higher contrast enhancement can compensate for the degradation of image quality resulting from use of a low radiation dose for CT. .\
\
###19297565\
BACKGROUND	The effect of screening with prostate-specific-antigen ( PSA ) testing and digital rectal examination on the rate of death from prostate cancer is unknown .\
BACKGROUND	This is the first report from the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial on prostate-cancer mortality .\
METHODS	From 1993 through 2001 , we randomly assigned 76,693 men at 10 U.S. study centers to receive either annual screening ( 38,343 subjects ) or usual care as the control ( 38,350 subjects ) .\
METHODS	Men in the screening group were offered annual PSA testing for 6 years and digital rectal examination for 4 years .\
METHODS	The subjects and health care providers received the results and decided on the type of follow-up evaluation .\
METHODS	Usual care sometimes included screening , as some organizations have recommended .\
METHODS	The numbers of all cancers and deaths and causes of death were ascertained .\
RESULTS	In the screening group , rates of compliance were 85 % for PSA testing and 86 % for digital rectal examination .\
RESULTS	Rates of screening in the control group increased from 40 % in the first year to 52 % in the sixth year for PSA testing and ranged from 41 to 46 % for digital rectal examination .\
RESULTS	After 7 years of follow-up , the incidence of prostate cancer per 10,000 person-years was 116 ( 2820 cancers ) in the screening group and 95 ( 2322 cancers ) in the control group ( rate ratio , 1.22 ; 95 % confidence interval [ CI ] , 1.16 to 1.29 ) .\
RESULTS	The incidence of death per 10,000 person-years was 2.0 ( 50 deaths ) in the screening group and 1.7 ( 44 deaths ) in the control group ( rate ratio , 1.13 ; 95 % CI , 0.75 to 1.70 ) .\
RESULTS	The data at 10 years were 67 % complete and consistent with these overall findings .\
CONCLUSIONS	After 7 to 10 years of follow-up , the rate of death from prostate cancer was very low and did not differ significantly between the two study groups .\
CONCLUSIONS	( ClinicalTrials.gov number , NCT00002540 . )\
\
###16962532\
OBJECTIVE	To compare the continuous knotless technique of perineal repair with the interrupted method after spontaneous vaginal birth\
METHODS	A randomized controlled trial .\
METHODS	Canadian Task Force Classification I.\
METHODS	This study was undertaken in a university hospital with more than 2200 deliveries per year .\
METHODS	The static population of this district includes a wide range of socioeconomic classes and is predominately white .\
METHODS	From May 1 to November 19 , 2003 , 214 primiparous women with a second-degree perineal tear or episiotomy were randomly allocated to either the continuous knotless technique ( CKT ; n = 107 ) or the interrupted technique ( IT ; n = 107 ) suturing method .\
METHODS	The interrupted technique ( IT ) involves placing 3 layers of sutures whereas the continuous knotless technique ( CKT ) involves reapproximating vaginal trauma , perineal muscles , and skin with a loose , continuous , nonlocking technique .\
RESULTS	The primary outcomes of the study were perineal pain ( evaluated by visual analogue scale ) at 48 hours and day 10 and dyspareunia 3 months after delivery .\
RESULTS	Secondary outcomes included suture removal , wound dehiscence , analgesia use up to 48 hours , and satisfaction with repair established at 3 and 12 months after childbirth .\
RESULTS	At day 10 , 19 women had dropped out of the study .\
RESULTS	Significantly fewer women reported pain at 10 days with the CKT than with the IT ( 32.3 % vs 60.4 % ; p < .001 ) .\
RESULTS	Analgesia use up to 48 hours postpartum was less in the CKT group than in the IT group ( 33.6 % vs 54.2 % ; p < .05 ) .\
RESULTS	No difference was found in superficial dyspareunia at 3 months for the CKT versus the IT group .\
CONCLUSIONS	The use of a continuous knotless technique for perineal repair is associated with less short-term pain than techniques with interrupted sutures .\
\
###19701513\
OBJECTIVE	To test the influence of thermomechanical loading and mode of cleaning the pulp chamber on coronal microleakage of adhesive sealings over root canal fillings .\
METHODS	Root canals of molars were instrumented to size 60 taper .02 and filled with AH plus ( Dentsply DeTrey ) and a single gutta-percha cone size 55 taper .02 .\
METHODS	After removal of residual sealer with an alcoholmoistened foam pellet , different pretreatments were performed : groups 1 and 5 : no further pretreatment ; groups 2 and 6 : use of a water cooled high-speed diamond bur ; groups 3 and 7 : etch-and-rinse with 37 % H3PO4 for 10 s ; groups 4 and 8 : diamond bur and etching .\
METHODS	Then Syntac ( Ivoclar Vivadent ) and two consecutive layers of Tetric flow ( Ivoclar Vivadent ) were applied .\
METHODS	After placing glass-ionomer cement as a provisional restoration , teeth of groups 5 to 8 were additionally subjected to thermomechanical loading ( chewing simulation of 200,000 cycles/50 N ) and thermocycling ( 2880 cycles between 5 degrees C and 55 degrees C ) .\
METHODS	A dye penetration test ( methylene blue dye 5 % , centrifugation for 3 min at 30 G ) was used to evaluate linear dye penetration and dye penetration area .\
METHODS	Statistical tests were performed using SPSS Win 12.0 ( Kolmogorov-Smirnov test , two-way ANOVA , t-test ) .\
RESULTS	Thermomechanical loading ( TML ) had a negative impact on coronal seal ( two-way ANOVA , p < 0.001 ) .\
RESULTS	Among TML groups , group 7 ( etch-and-rinse ) performed best , exhibiting the least influence of TML .\
CONCLUSIONS	For adhesive sealing of the pulp chamber floor , the etch-and-rinse technique combined with a flowable resin composite showed promising results .\
CONCLUSIONS	Nevertheless , a stabilizing restoration should be placed as soon as possible .\
\
###8377241\
OBJECTIVE	Recent studies of perioperative antimicrobial prophylaxis have indicated an improved efficacy of beta-lactamase-stable cephalosporins compared with cefazolin , the most commonly used prophylactic agent .\
OBJECTIVE	Previous studies in our institution have revealed a superiority of cefamandole to cefazolin in patients undergoing heart surgery , although there was no difference between cefazolin and cefuroxime in patients undergoing peripheral vascular surgery .\
OBJECTIVE	This study was therefore designed to compare cefamandole with cefazolin in wound infection prophylaxis in clean vascular surgery .\
METHODS	The study was conducted from August 1990 through May 1992 and consisted of 893 patients with aortic or infrainguinal arterial procedures randomized to receive either cefamandole or cefazolin .\
RESULTS	The difference in infection rates associated with cefamandole versus cefazolin prophylaxis ( 3.2 % vs 1.9 % , respectively ) was not significant ( p = 0.42 ) .\
RESULTS	A cost savings of approximately $ 95,000 per year at our institution favors the continued use of cefazolin over cefamandole .\
RESULTS	Risk factor analysis was carried out for preoperative and postoperative events that might have predisposed to infection .\
RESULTS	Only preoperative use of aspirin and the postoperative finding of a lymphocele correlated with a higher infection rate .\
CONCLUSIONS	Cefazolin continues to be the most cost-effective antibiotic for prophylaxis in clean vascular surgical procedures .\
\
###10613302\
OBJECTIVE	This study was an open label , randomized Phase 3 trial in newly diagnosed patients with anaplastic glioma comparing radiotherapy plus adjuvant procarbazine , CCNU , and vincristine ( PCV ) chemotherapy with or without bromodeoxyuridine ( BUdR ) given as a 96-hour infusion each week of radiotherapy .\
METHODS	Only patients 18 years or older with newly diagnosed anaplastic glioma were eligible ; central pathology review was accomplished , but was not mandated prior to registration .\
METHODS	The study had initially opened as a Northern California Oncology Group ( NCOG ) trial in 1991 , becoming an Intergroup RTOG , SWOG , and NCCTG study in July 1994 .\
METHODS	Total accrual of 293 patients was planned as the sample size , using survival and time to tumor progression as the primary endpoints .\
METHODS	The experiment arm ( RT/BUdR plus PCV ) was to be compared to the control arm ( RT plus PCV ) using an alpha = 0.05 , one-tailed , with a power of 85 % for detecting an increase in median survival from 160 to 240 weeks , assuming a 3-year follow-up after completion of enrollment .\
RESULTS	As of July 1996 , 281 patients had been randomized ; 53 ( 20 % ) were ineligible , primarily based upon central pathology review , and another 39 cases were canceled .\
RESULTS	In total , 30 % of cases were excluded from analysis .\
RESULTS	The treatment arms were well balanced despite this rate of exclusion .\
RESULTS	The RTOG Data Monitoring Committee recommended suspension of enrollment in July 1996 based upon a stochastic curtailment analysis which strongly suggested that the addition of BUdR would not be associated with increased survival .\
RESULTS	In February 1997 , the study was closed prior to full enrollment .\
RESULTS	At that time , the 1-year survival estimates were 82 % versus 68 % for RT plus PCV and RT/BUdR plus PCV respectively ( one-sided , p = 0.96 ) .\
RESULTS	The conditional power analysis indicated that even with an additional 12 months of additional accrual and follow-up the probability of detecting the prespecified difference was less than 0.01 % .\
RESULTS	The differences in the two arms seem to be due to early deaths in the BUdR arm , not related to toxicity of the treatment .\
CONCLUSIONS	Despite encouraging Phase 2 results with BUdR , it is unlikely that a survival benefit will be seen .\
CONCLUSIONS	A final study analysis will not be done for at least 3 more years .\
\
###20400097\
OBJECTIVE	To compare the effects of surgery on energy and protein metabolism in children randomized to undergo laparoscopic and open surgery .\
METHODS	We randomized 41 patients to open or laparoscopic Nissen fundoplication .\
METHODS	Anesthesia and postoperative management were standardized .\
METHODS	We recorded core temperature , respiratory gas exchange preoperatively , intraoperatively , and 4 and 24 hours postoperatively and calculated resting energy expenditure ( REE ) .\
METHODS	Protein breakdown was measured by using stable isotopic leucine infusion preoperatively and 4 hours postoperatively .\
RESULTS	Intraoperative core temperature and oxygen consumption increased in the laparoscopic group compared with the open group .\
RESULTS	REE decreased in the early postoperative period in the open group , but did not decrease after laparoscopy .\
RESULTS	REE at 4 hours was higher after laparoscopy .\
RESULTS	Protein breakdown also decreased in the early postoperative period ; the pattern of change between open and laparoscopic groups was of borderline significance .\
CONCLUSIONS	Laparoscopy in children may alter the changes in energy metabolism observed after open surgery .\
CONCLUSIONS	These differences may be partially caused by alterations in intraoperative thermoregulation and protein breakdown during laparoscopy in children .\
\
###17311621\
BACKGROUND	The pathogenesis of chronic hepatitis C ( CHC ) is associated to severe oxidative stress that leads to necro-inflammation and progression of fibrosis .\
BACKGROUND	Previous trials suggested that antioxidative therapy may have a beneficial effect .\
BACKGROUND	We evaluated the efficacy and safety of Viusid in combination with interferon alpha-2b ( IFN alpha-2b ) and ribavirin in patients with CHC .\
METHODS	We randomly assigned 100 patients , between October 2002 and December 2004 , in two arms : IFN alpha-2b ( 5 MU on alternate days ) , ribavirin at a dose of 13 mg/kg daily and Viusid ( three sachets daily ) vs. IFN alpha-2b ( 5 MU on alternate days ) and ribavirin at a dose of 13 mg/kg daily .\
METHODS	Subjects were treated for 48 weeks and then followed for an additional 24 weeks .\
METHODS	The primary end point was the histologic response ( reduction of at least two points without fibrosis worsening in the total score on the Histological Activity Index ) .\
RESULTS	A significantly high proportion of patients who received combined therapy plus Viusid had a histologic response better than those patients who received IFN alpha-2b and ribavirin ( 57 % vs. 37 % , P = 0.03 ) .\
RESULTS	The patients with virologic response achieved the highest percentages of histologic response , irrespective of assigned treatment .\
RESULTS	Among non-responders , the highest reduction in the mean change from baseline score for necro-inflammatory activity ( NA ) and fibrosis ( F ) was reported in patients treated with Viusid [ NA , -1.50 ( Viusid ) , -1.20 ( without Viusid ) ; F , -0.31 ( Viusid ) , 0.00 ( without Viusid ) ] .\
RESULTS	Sustained normalization of serum alanine aminotransferase concentration was highest in the Viusid group compared with standard therapy ( 67 % vs. 41 % , P = 0.009 ) .\
RESULTS	The overall safety profile was similar in both groups , but interestingly , the anemia was less intense in the group with Viusid ( P = 0.04 ) .\
CONCLUSIONS	Our results suggest that triple therapy with Viusid , IFN alpha-2b and ribavirin was well tolerated and may have a beneficial effect on histologic and biochemical variables .\
CONCLUSIONS	The intensity of anemia is reduced in patients treated with Viusid .\
\
###10525492\
BACKGROUND	Recent evidence from an animal model of stroke , the stroke-prone spontaneously hypertensive rat , implicated the gene encoding atrial natriuretic peptide ( ANP ) as a possible candidate contributing to the likelihood of experiencing a stroke .\
BACKGROUND	The purpose of the present study was to investigate the role of ANP in the pathogenesis of cerebrovascular accidents in humans .\
RESULTS	We investigated 2 previously known markers at ANP , G1837A and T2238C , for their possible association with the occurrence of stroke .\
RESULTS	This was the largest matched case-controlled sample studied thus far ; the sample was drawn from a large prospective study ( the Physician 's Health Study ) .\
RESULTS	When assuming a dominant mode of inheritance , a statistically significant positive association was observed for the 1837A allele , indicating an odds ratio of 1.64 ( 95 % confidence interval , 1.01 to 2.65 ) for stroke .\
RESULTS	This observation led to the discovery of a new molecular variant in exon 1 , G664A , which was responsible for a valine-to-methionine substitution in the proANP peptide .\
RESULTS	This mutation , which was in linkage disequilibrium with the G1837A marker , was associated with the occurrence of stroke ( odds ratio , 2.0 ; 95 % confidence interval , 1.17 to 3.19 ; P = 0.01 ) .\
CONCLUSIONS	Our findings suggest that molecular variants of the ANP gene may represent an independent risk factor for cerebrovascular accidents in humans .\
CONCLUSIONS	The strong parallelism to the experimental data obtained in the stroke-prone animal model provides assurance for the relevance of our observation .\
\
###22153558\
BACKGROUND	Due to the lacking specificity of symptoms making a correct diagnosis can be a challenge in children with medulloblastoma .\
BACKGROUND	This can lead to prediagnostic symptomatic intervals ( PSIs ) of several weeks to months .\
BACKGROUND	It is unknown whether the length of the PSI is associated with an inferior survival outcome in this population .\
METHODS	To study the association of PSI with disease stage at diagnosis , tumour control and survival in children with medulloblastoma , prospectively collected data on PSI , clinical , and biological features were analysed in 224 patients diagnosed at the age of 3-18 years and treated within the prospective randomised multicentre trial HIT ' 91 .\
RESULTS	Patients with lower-stage disease tended towards a longer median PSI than those with higher-stage disease ( M0 stage , 2.0 months ; M1 stage , 2.0 months ; M2/M3 stage , 1 month ; p = 0.094 .\
RESULTS	M0/1 stage versus M2/3 stage ; p = 0.025 ) .\
RESULTS	The patient group with the longest PSI had the best survival outcome ( PSI 4.0 months : 10-year overall survival rate ( OS ) , 71 % ; PSI < 4.0 months , 10-year OS , 61 % ; p = 0.056 ) .\
RESULTS	Age at diagnosis was positively correlated with PSI ( p = 0.027 ) .\
RESULTS	No associations were found between PSI and sex histological subtype , presence of postoperative residual tumour , or c-myc and TrkC mRNA expression .\
CONCLUSIONS	Contrary to a common belief that a longer PSI may adversely affect prognosis , a longer PSI was associated with a trend towards lower metastatic stage and better survival probabilities .\
CONCLUSIONS	Nevertheless these findings do not obviate the importance of a timely diagnosis in paediatric patients with medulloblastoma .\
\
###19896325\
BACKGROUND	Peripheral neuropathy is one of the most common complications of diabetes .\
OBJECTIVE	The purpose of this study was to evaluate the effects of photon stimulation on pain intensity , pain relief , pain qualities , sensation and quality of life ( QOL ) in patients with painful diabetic peripheral neuropathy .\
METHODS	In this randomized , placebo-controlled trial , patients were assigned to receive either four photon stimulations ( n = 63 ) or four placebo ( n = 58 ) treatments .\
METHODS	Pain intensity , pain relief , and pain qualities were assessed using self-report questionnaires .\
METHODS	Sensation was evaluated using monofilament testing .\
METHODS	QOL was measured using the Medical Outcomes Study Short Form-36 ( SF-36 ) .\
METHODS	Multilevel regression model analyses were used to evaluate between-group differences in study outcomes .\
RESULTS	No differences , over time , in any pain intensity scores ( i.e. , pain intensity immediately post-treatment , average pain , worst pain ) or pain relief scores were found between the placebo and treatment groups .\
RESULTS	However , significant decreases , over time , were found in some pain quality scores , and significant improvements in sensation were found in patients who received the photon stimulation compared with placebo .\
RESULTS	In addition , patients in the treatment group reported significant improvements in SF-36 social functioning and mental health scores .\
RESULTS	Findings from a responder analysis demonstrated that no differences were found in the percentages of patients in the placebo and treatment groups who received 30 % or more or 50 % or more reduction in pain scores immediately post-treatment .\
RESULTS	However , significant differences were found in the distribution of the changes in pain relief scores , with most of the patients in the photon stimulation group reporting a slight ( 28.6 % ) to moderate ( 34.9 % ) improvement in pain relief from the beginning to the end of the study compared with no change in pain relief ( 43.1 % ) in the placebo group .\
CONCLUSIONS	Four treatments with photon stimulation resulted in significant improvements in some pain qualities , sensation , and QOL outcomes in a sample of patients with a significant amount of pain and disability from their diabetes .\
CONCLUSIONS	A longer duration study is needed to further refine the photon stimulation treatment protocol in these chronically ill patients and to evaluate the sustainability of its effects .\
\
###15016259\
OBJECTIVE	To evaluate bone-level alterations that occurred at implants of the Astra Tech ( R ) System that were placed in the load carrying , posterior parts of the dentition using either a submerged ( two-stage ) or a non-submerged ( one-stage ) installation protocol .\
METHODS	Eighty-four patients that required 115 fixed partial dentures ( FPDs or cases ) entered the prospective study .\
METHODS	All subjects were assigned one patient and > or = one case numbers .\
METHODS	For the randomization of cases , a custom-made program based on balanced random permuted blocks was utilized .\
METHODS	The cases were assigned to two treatment groups , namely one-stage installation procedure , non-submerged technique ( group A ) and two-stage installation procedure , submerged technique ( group B ) .\
METHODS	Several subjects contributed with cases to both groups A and B. Periodontal , endodontal and open caries lesions were treated prior to implant installation .\
METHODS	All patients received careful oral hygiene instruction and training in self-performed plaque control measures .\
METHODS	The surgical technique used for fixture installation followed the outline described in the manual for the Astra Tech System .\
METHODS	The FPDs were placed 3 months ( mandible ) and 6 months ( maxilla ) following implant installation .\
METHODS	Immediately following FPD placement , a baseline examination was performed that included assessment of plaque , soft-tissue inflammation and bone level .\
METHODS	Clinicians who were otherwise not involved in the study performed the radiographic measurements .\
METHODS	Clinical and radiographical examinations were repeated once a year after the baseline examination .\
METHODS	The primary outcome variable was the change in the bone level at the implants from the time of placement of the bridge ( FPD ) to the 1 - and 2-year reexaminations .\
METHODS	Fisher 's permutation test was used to test if differences existed between groups A and B , and between patients ( men/women , smokers/non-smokers , age ) , sites ( maxilla/mandible ) and implants ( length , diameter ) .\
METHODS	Pitman 's test was used to study correlations between bone shape and quality data and different radiographic bone-level data .\
RESULTS	It was demonstrated that tissue healing following implant installation appeared to be independent of the surgical protocol , i.e. whether the marginal portions of the implants during surgery were fully or only partly submerged under the ridge mucosa .\
RESULTS	Thus , ( i ) in both treatment groups the number of implants that failed to osseointegrate ( early failures ) was small ( < 2 % ) ; ( ii ) at the end of the recommended periods of bone healing prior to loading , - in both groups , maxilla = 6 months and mandible = 3 months - the level of the marginal bone was close to the coronal rim of the fixture ; group A : 1.54 + / -0.92 mm , group B : 1.31 + / -0.77 mm .\
RESULTS	The current study also demonstrated that irrespective of surgical protocol ( two-stage , one-stage ) , implants supporting the FPDs exhibited only small amount of radiographic bone loss during the first year of function ( group A : 0.02 + / -038 mm , group B : 0.17 + / -0.64 mm ) .\
RESULTS	Moreover , during the second year of function , the amount of additional bone loss that occurred in the two treatment groups was close to zero .\
CONCLUSIONS	Periimplant bone-level change during function seemed to be unrelated to whether initial soft - and hard-tissue healing following implant installation had occurred under submerged or non-submerged conditions .\
\
###17679017\
BACKGROUND	Cervical cancer is the most common cancer among women in developing countries .\
BACKGROUND	We assessed the effect of screening using visual inspection with 4 % acetic acid ( VIA ) on cervical cancer incidence and mortality in a cluster randomised controlled trial in India .\
METHODS	Of the 114 study clusters in Dindigul district , India , 57 were randomised to one round of VIA by trained nurses , and 57 to a control group .\
METHODS	Healthy women aged 30 to 59 years were eligible for the study .\
METHODS	Screen-positive women had colposcopy , directed biopsies , and , where appropriate , cryotherapy by nurses during the screening visit .\
METHODS	Those with larger precancerous lesions or invasive cancers were referred for appropriate investigations and treatment .\
METHODS	Cervical cancer incidence and mortality in the study groups were analysed and compared using Cox regression taking the cluster design into account , and analysis was by intention to treat .\
METHODS	The primary outcome measures were cervical cancer incidence and mortality .\
RESULTS	Of the 49,311 eligible women in the intervention group , 31,343 ( 63.6 % ) were screened during 2000-03 ; 30,958 control women received the standard care .\
RESULTS	Of the 3088 ( 9.9 % ) screened positive , 3052 had colposcopy , and 2539 directed biopsy .\
RESULTS	Of the 1874 women with precancerous lesions in the intervention group , 72 % received treatment .\
RESULTS	In the intervention group , 274,430 person years , 167 cervical cancer cases , and 83 cervical cancer deaths were accrued compared with 178,781 person-years , 158 cases , and 92 deaths and in the control group during 2000-06 ( incidence hazard ratio 0.75 [ 95 % CI 0.55-0 .95 ] and mortality hazard ratio 0.65 [ 0.47-0 .89 ] ) .\
CONCLUSIONS	VIA screening , in the presence of good training and sustained quality assurance , is an effective method to prevent cervical cancer in developing countries .\
\
###18072989\
BACKGROUND	Numerous patients are assessed in the emergency department ( ED ) for chest pain suggestive of acute coronary syndrome ( ACS ) and subsequently discharged if found to be at low risk .\
BACKGROUND	Exercise stress testing is frequently advised as a follow-up investigation for low-risk patients ; however , compliance with such recommendations is poorly understood .\
BACKGROUND	We sought to determine if compliance with follow-up for exercise stress testing is higher in patients for whom the investigation is ordered at the time of ED discharge , compared with patients who are advised to arrange testing through their family physician ( FP ) .\
METHODS	Low-risk chest pain patients being discharged from the ED for outpatient exercise stress test and FP follow-up were randomized into 2 groups .\
METHODS	ED staff ordered an exercise stress test for the intervention group , and the control group was advised to contact their FP to arrange testing .\
METHODS	The primary outcome was completion of an exercise stress test at 30 days , confirmed through both patient contact and stress test results .\
METHODS	Patients were unaware that our primary interest was their compliance with the exercise stress testing recommendations .\
RESULTS	Two-hundred and thirty-one patients were enrolled and baseline characteristics were similar between the 2 groups .\
RESULTS	Completion of an exercise stress test at 30 days occurred in 87 out of 120 ( 72.5 % ) patients in the intervention group and 60 out of 107 ( 56.1 % ) patients in the control group .\
RESULTS	The difference in compliance rates ( 16.4 % ) between the 2 groups was statistically significant ( Chi ( 2 ) = 6.69 , p < 0.001 ) with a relative risk of 1.29 ( 95 % confidence interval 1.18-1 .40 ) , and the results remained significant after a `` worst case '' sensitivity analysis involving 4 control group cases lost to follow-up .\
RESULTS	When subjects were contacted by telephone 30 days after the ED visit , 60 % of those who were noncompliant patients felt they did not have a heart problem and that further testing was unnecessary .\
CONCLUSIONS	When ED staff order an outpatient exercise stress test following investigation for potential ACS , patients are more likely to complete the test if it is booked for them before ED discharge .\
CONCLUSIONS	After discharge , many low-risk chest pain patients feel they are not at risk and do not return to their FP for further testing in a timely manner as advised .\
CONCLUSIONS	Changing to a strategy of ED booking of exercise stress testing may help earlier identification of patients with coronary heart disease .\
\
###11257953\
OBJECTIVE	To compare the efficacy and side effects of three doses of metoclopramide , droperidol or placebo administered every 8 h to prevent nausea and vomiting during the first 24 h after surgery .\
METHODS	Prospective , double blind study of 104 patients scheduled for major intraabdominal gynecological surgery under general anesthesia .\
METHODS	The patients were randomly assigned to three groups : group M received 10 mg of metoclopramide , group D received 1.25 mg of droperidol and group P received a saline solution .\
METHODS	The patients were premedicated with oral diazepam .\
METHODS	All patients were anesthetized using similar techniques , with fentanyl , thiopental , vecuronium , oxygen/nitrogen protoxide and isoflurane .\
METHODS	Muscle relaxation was reversed with atropine and neostigmine .\
METHODS	Postoperative analgesia was given with endovenous morphine and metamizol .\
METHODS	Immediately after surgery each patient received an endovenous dose of the assigned antiemetic drug .\
METHODS	Patients were monitored for 24 h and observations were recorded every hour on the following scale : 0 , for no emetic symptoms , 1 for nausea and 2 for vomiting .\
RESULTS	Fifteen patients ( 42.9 % ) in group D , 21 ( 60 % in group M and 19 ( 54.3 % ) in group P experienced nausea during the 24 h after surgery , with no significant differences .\
RESULTS	However , the incidence of vomiting was significantly lower in group D , with 7 patients ( 20 % ) vomiting in group D versus 11 patients ( 31.43 % ) in group M and 17 ( 50 % ) in group P. Side effects were mild and required no treatment .\
CONCLUSIONS	Droperidol at a dose of 1.25 mg every 8 h is effective and safe for preventing postoperative nausea and vomiting and has minimal side effects .\
CONCLUSIONS	Metoclopramide at a dose of 10 mg every 8 h , in our study , was no better for the same purpose than placebo .\
\
###20678687\
OBJECTIVE	This study compared the bioavailability and tolerability of a fixed-dose combination ( FDC ) tablet of glimepiride/metformin 2/500 mg and glimepiride 2-mg + metformin 500-mg tablets administered separately in healthy Korean subjects .\
METHODS	In this single-dose , open-label , 2-period crossover study , healthy Korean volunteers were randomly assigned to receive , in 1 of 2 randomized sequences , an FDC tablet of glimepiride/metformin 2/500 mg ( test ) and glimepiride 2-mg + metformin 500-mg tablets administered separately ( reference ) , with a 1-week washout period between treatments .\
METHODS	Plasma concentrations of glimepiride and metformin were measured using LC/MS-MS .\
METHODS	Pharmacokinetic parameters were analyzed using noncompartmental methods .\
METHODS	Bioequivalence was concluded if the 90 % CIs of the geometric mean test/reference ratios ( GMRs ) of the logarithm-transformed C ( max ) , AUC from 0 to 30 hours ( AUC ( 0-30 ) ) , and AUC ( 0-infinity ) values were within the predetermined regulatory range of 80 % to 125 % .\
METHODS	Tolerability was assessed using physical examination and laboratory analysis .\
RESULTS	A total of 32 subjects were enrolled ( 16 men [ mean ( SD ) age , 21.8 ( 2.7 ) years ( range , 18-26 years ) ; weight , 68.9 ( 8.3 ) kg ( range , 55.5-85 .0 kg ) ] ; 16 women [ age , 23.5 ( 4.5 ) years ( range , 20-38 years ) ; weight , 51.7 ( 3.5 ) kg ( range , 46.8-58 .0 kg ) ] ) .\
RESULTS	The GMRs ( 90 % CI ) of glimepiride C ( max ) , AUC ( 0-30 ) , and AUC ( 0-infinity ) were 1.01 ( 0.91-1 .11 ) , 0.98 ( 0.92-1 .03 ) , and 0.97 ( 0.93-1 .04 ) , respectively .\
RESULTS	For metformin , these values were 0.96 ( 0.87-1 .06 ) , 0.96 ( 0.90-1 .03 ) , and 0.96 ( 0.90-1 .03 ) .\
RESULTS	A total of 49 adverse events ( AEs ) were reported in 10 subjects ( 31.3 % ) with the FDC and in 13 subjects ( 40.6 % ) with the separate tablets .\
RESULTS	The most commonly reported AEs with the test and reference treatments were dizziness ( 6 [ 19 % ] and 7 [ 22 % ] ) and sweating ( 4 [ 13 % ] and 7 [ 22 % ] ) , respectively .\
RESULTS	The severity of all of the AEs was considered to be mild , and there were no significant differences in the prevalences of AEs between the 2 formulations .\
CONCLUSIONS	In this study in healthy Korean subjects , the requirements for bioequivalence of the glimepiride/metformin 2/500-mg FDC and coadministration of separate tablets of each drug were met .\
CONCLUSIONS	Both formulations were generally well tolerated .\
\
###22426706\
BACKGROUND	Accurate patient problem lists are valuable tools for improving the quality of care , enabling clinical decision support , and facilitating research and quality measurement .\
BACKGROUND	However , problem lists are frequently inaccurate and out-of-date and use varies widely across providers .\
OBJECTIVE	Our goal was to assess provider use of an electronic problem list and identify differences in usage between medical specialties .\
METHODS	Chart review of a random sample of 100,000 patients who had received care in the past two years at a Boston-based academic medical center .\
METHODS	Counts were collected of all notes and problems added for each patient from 1/1/2002 to 4/30/2010 .\
METHODS	For each entry , the recording provider and the clinic in which the entry was recorded was collected .\
METHODS	We used the Healthcare Provider Taxonomy Code Set to categorize each clinic by specialty .\
METHODS	We analyzed the problem list use across specialties , controlling for note volume as a proxy for visits .\
RESULTS	A total of 2,264,051 notes and 158,105 problems were recorded in the electronic medical record for this population during the study period .\
RESULTS	Primary care providers added 82.3 % of all problems , despite writing only 40.4 % of all notes .\
RESULTS	Of all patients , 49.1 % had an assigned primary care provider ( PCP ) affiliated with the hospital ; patients with a PCP had an average of 4.7 documented problems compared to 1.5 problems for patients without a PCP .\
CONCLUSIONS	Primary care providers were responsible for the majority of problem documentation ; surgical and medical specialists and subspecialists recorded a disproportionately small number of problems on the problem list .\
\
###18325025\
OBJECTIVE	Our work evaluates visual function before and after treatment with cytidine-5-diphosphocholine ( Citicoline ) in patients with non-arteritic ischaemic optic neuropathy ( NION ) .\
METHODS	Twenty-six patients in which at least 6 months elapsed from NION , were randomly divided into two age-similar groups : 14 patients had Citicoline ( Cebrolux-Tubilux , Italy , 1600 mg/diem for 60 days , followed by a 120-day period of wash out , days 60-180 ) ( T-NION ) ; 12 patients had no treatment during the same period ( NT-NION ) .\
METHODS	At day 180 , in T-NION a second period of treatment ( days 181-240 ) followed by a wash-out ( days 241-360 ) was performed .\
METHODS	Fourteen age-matched healthy subjects provided normative data .\
METHODS	In all patients , pattern-electroretinogram ( PERG ) , visual evoked potentials ( VEPs ) and visual acuity ( VA ) measurements were performed at baseline and at days 60 and 180 .\
METHODS	In T-NION , further measurements were achieved at days 240 and 360 .\
RESULTS	At baseline , NT-NION and T-NION patients showed abnormal PERGs and VEPs , and reduced VA , compared to controls .\
RESULTS	At the end of treatment ( days 60 and 240 ) , T-NION patients showed improvement ( P < 0.01 ) of PERGs , VEPs parameters and VA , compared to pre-treatment values .\
RESULTS	After wash out , functional improvements persisted compared to baseline .\
RESULTS	No changes in NT-NION patients were observed .\
CONCLUSIONS	Our results suggest a beneficial effect of oral Citicoline in NION .\
\
###8729158\
OBJECTIVE	To assess the effect of a tissue-engineered human dermis ( Dermagraft ) in healing diabetic foot ulcers .\
METHODS	This controlled prospective multicenter randomized single-blinded pilot study evaluated healing over a 12-week period in 50 patients with diabetic foot ulcers .\
METHODS	These patients were randomized into four groups ( three different dosage regimens of Dermagraft and one control group ) .\
METHODS	All patients received identical care except for the use of Dermagraft tissue .\
METHODS	Ulcer healing was assessed by percentage of wounds achieving complete or 50 % closure , time to complete or 50 % closure , and volume and area measurements .\
RESULTS	Ulcers treated with the highest dosage of Dermagraft , one piece applied weekly for 8 weeks ( group A ) , healed significantly more often than those treated with conventional wound closure methods ; 50 % ( 6 of 12 ) of the Dermagraft-treated and 8 % ( 1 of 13 ) of the control ulcers healed completely ( P = 0.03 ) .\
RESULTS	The percentage of wounds achieving 50 % closure was also significantly higher ( 75 vs. 23 % ; P = 0.018 ) , and the time to complete or 50 % closure was faster ( P = 0.056 ) .\
RESULTS	The group A regimen was more effective than other treatment regimens .\
RESULTS	All three were better than the control , however , and a dose-response was observed .\
RESULTS	There were no safety concerns .\
RESULTS	After a mean of 14 months of follow-up ( range 11-22 months ) , there were no recurrences in the Dermagraft-healed ulcers .\
CONCLUSIONS	Dermagraft was associated with more complete and rapid healing in diabetic foot ulcers .\
CONCLUSIONS	The recurrence data may indicate an improved quality of wound healing .\
\
###10194995\
OBJECTIVE	To determine the effect of erythromycin on the establishment of enteral feeding in ventilated infants < 31 weeks gestation .\
METHODS	Erythromycin was randomly allocated as an antimicrobial treatment for the first 7 days of life in 76 infants : 35 received erythromycin and 41 acted as controls .\
METHODS	Feed toleration , time taken to establish full enteral feeding , vomiting , prescription of glycerine suppositories and occurrence of necrotising enterocolitis were recorded .\
RESULTS	There were no significant differences between the groups for any of the outcomes .\
RESULTS	The infants treated with erythromycin reached full feeding at a median ( quartile ) age of 8 ( 5-12 ) days compared with 9 ( 6-14 ) days for controls .\
CONCLUSIONS	Intravenous erythromycin in antimicrobial doses is unlikely to benefit the introduction of feeding in preterm infants .\
\
###12077091\
BACKGROUND	Recent data have outlined a relationship between the composition of the intestinal microflora and allergic inflammation , and demonstrated the competence of probiotics in downregulation of such inflammation .\
OBJECTIVE	Our aims were to characterise the relationship between gut microbes and the extent of allergic sensitisation and to assess whether the efficacy of bifidobacterial supplementation in the treatment of allergy could relate to modulation of the intestinal microbiota .\
METHODS	This randomised study included 21 infants with early onset atopic eczema of whom eight were intolerant ( highly sensitised group ( HSG ) ) and 13 tolerant ( sensitised group ( SG ) ) to extensively hydrolysed whey formula ( EHF ) .\
METHODS	In the SG , six were weaned to EHF without ( placebo group ( PG ) ) and seven to EHF with Bifidobacterium lactis Bb-12 supplementation ( bifidobacteria treated group ( BbG ) ) .\
METHODS	The faecal microflora of infants in the HSG was analysed only before weaning whereas in the SG the faecal microflora was analysed both before and after weaning .\
RESULTS	Infants in the HSG had greater numbers of lactobacilli/enterococci than those in the SG .\
RESULTS	Serum total IgE concentration correlated directly with Escherichia coli counts in all infants and with bacteroides counts in the HSG , indicating that the presence of these bacteria is associated with the extent of atopic sensitisation .\
RESULTS	The effect of supplementation was characterised as a decrease in the numbers of Escherichia coli and protection against an increase in bacteroides numbers during weaning .\
CONCLUSIONS	These data indicate that bifidobacterial supplementation appears to modify the gut microbiota in a manner that may alleviate allergic inflammation .\
CONCLUSIONS	Further studies are needed to confirm this conclusion .\
\
###17394661\
BACKGROUND	There have been few prospective studies examining the utility of routine exercise treadmill testing ( ETT ) early after percutaneous coronary intervention ( PCI ) .\
BACKGROUND	The objective of this study was to examine the impact of a routine ETT strategy early after PCI on follow-up cardiac events and procedures .\
METHODS	We examined 136 patients who underwent routine ETT at 6 weeks post-PCI in the ADORE trial .\
METHODS	The ETT was classified as positive , indeterminate , or negative .\
METHODS	The Duke Treadmill Score ( DTS ) was calculated for all patients .\
METHODS	Follow-up occurred at 9 months .\
RESULTS	ETT results at 6 weeks were : 32 ( 23.5 % ) positive , 24 ( 17.6 % ) indeterminate and 80 ( 58.8 % ) negative .\
RESULTS	At 9 months , the composite event rate was 21.9 % in those with a positive ETT , 20.8 % in those with an indeterminate ETT and 12.5 % in those with a negative ETT ( p = 0.25 positive vs. negative ETT ) .\
RESULTS	The sensitivity of early ETT for predicting clinical events was 41.2 % , the specificity was 73.3 % , the positive predictive value was 21.9 % and the negative predictive value was 87.5 % .\
RESULTS	At 9 months , the cardiac procedure rate was 18.8 % in those with a positive test , 13.0 % in those with an indeterminate test , and 6.3 % in those with a negative test ( p = 0.07 positive vs. negative ETT ) .\
RESULTS	In a multivariate logistic regression model , coronary stenting during PCI and a > / = 85 % MPHR achieved were found to be inversely associated with clinical events .\
RESULTS	However , the DTS did not independently predict clinical events .\
CONCLUSIONS	Although the statistical power of the study was limited by the small number of clinical events ( particularly MI and death ) , the results of this study support the ACC/AHA guidelines that exercise treadmill testing should not be used routinely after PCI .\
\
###15735445\
OBJECTIVE	To determine nevirapine ( NVP ) plasma levels during the postpartum period after a single intrapartum NVP dose for the prevention of mother-to-child transmission .\
METHODS	Plasma samples at delivery and during days 8 to 45 postpartum were obtained from HIV-infected Thai women who received an intrapartum NVP dose in the Perinatal HIV Prevention Clinical Trial-2 ( PHPT-2 ) for the prevention of perinatal HIV transmission .\
METHODS	These data were combined with NVP concentration data from 2 phase 1 studies of NVP for a population analysis .\
RESULTS	The median NVP level fell to 68 ng/mL ( range : < 50-228 , n = 43 ) 8 to 14 days after dosing and to 51 ng/mL ( range : < 50-166 , n = 25 ) between 15 and 21 days .\
RESULTS	During the second and third weeks postpartum , NVP levels were below the limit of quantitation in 23 % and 44 % of samples , respectively .\
RESULTS	Between 21 and 45 days , no sample had a quantifiable NVP concentration .\
RESULTS	A simulation derived from the population analysis predicts that NVP concentration falls to less than 10 ng/mL in 5 % of women by 11 days , in 50 % of women by 17.5 days , and in 95 % of women by 28 days .\
CONCLUSIONS	Significant NVP concentrations remained for up to 20 days in these Thai women .\
CONCLUSIONS	To ensure that coverage is maintained until NVP concentrations fall to nonsuppressive levels , 1 month of additional antiretroviral treatment after delivery should be considered to prevent the emergence of resistant viruses .\
\
###23313985\
BACKGROUND	The recovery of elbow flexion in upper brachial plexus injury can be achieved by the reinnervation of the biceps muscle ( single reinnervation ) , but concomitant restoration of brachialis and biceps function ( double reinnervation ) has been recommended to improve elbow flexion strength .\
OBJECTIVE	To prospectively compare morbidity and outcomes of single or double muscle reinnervation in restoring elbow flexion following incomplete injury to the brachial plexus .\
METHODS	Forty consecutive patients were prospectively submitted to single or double muscle reinnervation .\
METHODS	Elbow flexion strength was evaluated with a push-and-pull dynamometer 12 months after surgery .\
METHODS	Hand morbidity related to the procedures was evaluated by the Semmes-Weinstein monofilaments test , quantification of static 2-point discrimination , and measurements of handgrip and lateral pinch strength in serial evaluations up to the final follow-up .\
RESULTS	Similar results for the strength of elbow flexion were observed in both groups .\
RESULTS	A worsening of sensibility , measured by using Semmes-Weinstein monofilaments , was identified in 8 patients , all of whom showed recovery during follow-up .\
RESULTS	No worsening of 2-point discrimination was observed .\
RESULTS	A decrease in handgrip and lateral pinch strength was identified in 8 and 9 patients , respectively , which improved during follow-up .\
RESULTS	There was no difference between the groups in the incidence of hand motor morbidity parameters .\
CONCLUSIONS	The strength of elbow flexion did not differ significantly between the groups treated with single or double muscle reinnervation .\
CONCLUSIONS	Deterioration of handgrip , lateral pinch strength , and sensibility measured by using Semmes-Weinstein monofilaments , was temporary , resulting in low morbidity for both techniques .\
\
###17352962\
OBJECTIVE	Watermelon is a rich source of citrulline , an amino acid that can be metabolized to arginine , a conditionally essential amino acid for humans .\
OBJECTIVE	Arginine is the nitrogenous substrate used in the synthesis of nitric oxide and plays an essential role in cardiovascular and immune functions .\
OBJECTIVE	No detailed studies have been conducted to evaluate plasma arginine response in humans after long-term feeding of citrulline from natural plant sources .\
OBJECTIVE	This study investigated if watermelon juice consumption increases fasting concentrations of plasma arginine , ornithine , and citrulline in healthy adult humans .\
METHODS	Subjects ( n = 12-23 / treatment ) consumed a controlled diet and 0 ( control ) , 780 , or 1560 g of watermelon juice per day for 3 wk in a crossover design .\
METHODS	The treatments provided 1 and 2 g of citrulline per day .\
METHODS	Treatment periods were preceded by washout periods of 2 to 4 wk .\
RESULTS	Compared with the baseline , fasting plasma arginine concentrations increased 12 % after 3 wk of the lower-dose watermelon treatment ; arginine and ornithine concentrations increased 22 % and 18 % , respectively , after 3 wk of the higher-dose watermelon treatment .\
RESULTS	Fasting citrulline concentrations did not increase relative to the control but remained stable throughout the study .\
CONCLUSIONS	The increased fasting plasma concentrations of arginine and ornithine and stable concentrations of plasma citrulline in response to watermelon juice consumption indicated that the citrulline from this plant origin was effectively converted into arginine .\
CONCLUSIONS	These results demonstrate that plasma concentration of arginine can be increased through intake of citrulline from watermelon .\
\
###15084207\
BACKGROUND	Our aim was to compare the distribution and determinants of heart rate variability ( HRV ) measures in a middle-aged population with patients of the same sex and age after an acute myocardial infarction ( AMI ) , and to show , whether HRV values defined as abnormal from the general population are indicative for a worse prognosis even in AMI patients .\
METHODS	HRV was studied in a random sample of 149 middle-aged men and 137 women from the general population ( 45-65 years ) as well as 129 consecutive AMI patients ( 25-74 years ) .\
METHODS	Spectral analysis was used to compute low frequency ( LF ) , high frequency ( HF ) , and total frequency power .\
METHODS	To the AMI population of age 45-65 years ( N = 85 ) a sample out of the general population was matched by age and sex by 2:1 matching ( N = 149 ) .\
METHODS	All AMI patients were followed for a median of 43 months ( range 1-47 ) for death or malignant arrhythmia .\
RESULTS	All measures of HRV were significantly and substantially lower in AMI patients than the general population ( P < 0.001 ) .\
RESULTS	Expression in relative terms revealed that the proportionate contributions of HF and LF to total power were significantly different in the two populations with relatively lower LF power in AMI patients ( P < 0.01 ) .\
RESULTS	The negative correlation with heart rate and HRV measures was significantly more pronounced in AMI patients ( P < 0.01 ) .\
RESULTS	The 2.5 th percentile of the LF power distribution in the general population ( 3.08 ln ms2 ) corresponds to the 25th percentile in the AMI population .\
RESULTS	Subjects of the whole AMI population with values below this LF cutpoint revealed a significant increased risk of death or malignant arrhythmia during follow-up ( odds ratio 5.1 ; 95 % confidence interval : 1.3 ; 23 ) .\
CONCLUSIONS	AMI patients had strongly diminished HRV compared to the general population .\
CONCLUSIONS	The relatively lower LF power indicates an alteration of the sympathico-vagal balance , and the significantly stronger correlation of heart rate with HRV may be indicative for a more pronounced effect of sympathetic activation on autonomic modulation in the case of myocardial infarction .\
CONCLUSIONS	Finally , a value below the 2.5 th percentile of the population LF power distribution may identify subjects at risk and warrant further testing .\
\
###9532990\
OBJECTIVE	To determine whether the administration of prophylactic intravenous magnesium sulphate reduces the occurrence of eclampsia in women with severe pre-eclampsia .\
METHODS	Randomised controlled trial .\
METHODS	A tertiary referral obstetric unit .\
METHODS	Eight hundred and twenty-two women with severe pre-eclampsia requiring termination of pregnancy by induction of labour or caesarean section .\
METHODS	The women were randomised to receive either placebo ( saline ) or magnesium sulphate intravenously .\
METHODS	The investigators were blinded to the contents of the pre-mixed solutions .\
METHODS	The occurrence of eclampsia in the two groups .\
RESULTS	The data of 699 women were evaluated .\
RESULTS	Fourteen were withdrawn after randomisation .\
RESULTS	The overall incidence of eclampsia was 1.8 % .\
RESULTS	Of 345 women who received magnesium sulphate , one developed eclampsia ( 0.3 % ) ; in the placebo group , 11/340 women ( 3.2 % ) developed eclampsia ( relative risk 0.09 ; 95 % confidence interval 0.01-0 .69 ; P = 0.003 ) .\
CONCLUSIONS	The use of intravenous magnesium sulphate in the management of women with severe pre-eclampsia significantly reduced the development of eclampsia .\
\
###25527243\
OBJECTIVE	Adherence to prescribed exercise is a challenge for cancer patients undergoing treatment .\
OBJECTIVE	The changing pattern of exercise adherence over time can not be fully understood by an overall measure of adherence .\
OBJECTIVE	This study was aimed to identify the trajectory of exercise adherence and its predictors for women with breast cancer during their chemotherapy .\
METHODS	Participants were 78 women with breast cancer assigned to the exercise arm of a randomized control trial .\
METHODS	Based on the weekly adherence rates in time and intensity , patients were classified as good ( > 100 % ) , acceptable ( 80-100 % ) , and poor ( < 80 % ) adherents .\
METHODS	Data were analyzed using ordinal logistic hierarchical linear modeling .\
RESULTS	The trajectories for both time and intensity adherence declined significantly .\
RESULTS	The decline in exercise-time adherence was significantly slower in women who reported higher interest in exercise .\
RESULTS	Women with higher perceived importance of exercise , early disease stage , and employed were more likely to be classified as good intensity adherents .\
RESULTS	Poorer weekly adherence for both exercise time and intensity was associated with higher fatigue level for that week .\
CONCLUSIONS	Adherence to exercise adherence in breast cancer patients declined as the dose of exercise prescription increased .\
CONCLUSIONS	Factors influencing overall adherence and adherence trend were identified .\
\
###17828747\
BACKGROUND	A 4-week course of high-dose glucocorticoids may cause prolonged adrenal suppression even after a 9-day tapering phase .\
BACKGROUND	In this study , adrenal function and signs and symptoms of adrenal insufficiency were prospectively assessed in children with acute lymphoblastic leukemia ( ALL ) after induction treatment including high-dose prednisone ( PDN ) or dexamethasone ( DXM ) .\
METHODS	Sixty-four children with ALL , treated according to the AIEOP ALL 2000 Study protocol , underwent low dose ACTH ( LD-ACTH ) stimulation 24 hr after the last tapered steroid dose .\
METHODS	In those with impaired cortisol response , additional LD ACTH tests were performed every 1-2 weeks until cortisol levels normalized .\
METHODS	Signs and symptoms of adrenal insufficiency were recorded during the observation period .\
RESULTS	All patients had normal basal cortisol values at diagnosis .\
RESULTS	Twenty-four hours after last glucocorticoid dose , morning cortisol was reduced in 40/64 ( 62.5 % ) patients .\
RESULTS	LD-ACTH testing showed adrenal suppression in 52/64 ( 81.5 % ) patients .\
RESULTS	At the following ACTH test 7-14 days later , morning cortisol values were reduced in 8/52 ( 15.4 % ) patients and response to the test was impaired in 12/52 ( 23 % ) .\
RESULTS	Adrenal function completely recovered in all patients within 10 weeks .\
RESULTS	No difference was found between patients treated with PDN or DXM .\
RESULTS	Almost 35 % of children with impaired cortisol values at the first test developed signs or symptoms of adrenal insufficiency .\
RESULTS	One child developed a severe adrenal crisis during adrenal suppression .\
CONCLUSIONS	High-dose glucocorticoid therapy in ALL children may cause prolonged adrenal suppression and related clinical symptoms .\
CONCLUSIONS	Laboratory monitoring of cortisol levels and steroid coverage during stress episodes may be indicated .\
\
###10968848\
BACKGROUND	Currently available aqueous purgatives used before colonoscopy are poorly tolerated .\
BACKGROUND	We designed a tableted sodium phosphate purge that we believe will yield much greater patient acceptance .\
METHODS	A total of 305 outpatients undergoing routine diagnostic colonoscopy were randomized to one of three preparation groups : Colyte ( 100 patients ) , Fleet Phospho-Soda ( 106 patients ) , or sodium phosphate tablets ( 99 patients ) .\
METHODS	Endoscopists were blinded to the type of preparation administered and answered a questionnaire regarding preparation quality .\
METHODS	Patients answered a questionnaire designed to analyze tolerability .\
METHODS	Adverse events were closely followed and recorded .\
RESULTS	There were no significant differences in quality of preparation across the groups ( 80 % excellent or good , 4 % repreparation ) .\
RESULTS	Although hypocalcemia ( 4 of 71 ) , hypokalemia ( 18 of 68 ) , and hyperphosphatemia ( 39 of 69 ) were observed in patients receiving the tablets , no adverse events occurred .\
RESULTS	Patients preferred taking the tablets over Colyte and Fleet Phospho-Soda .\
CONCLUSIONS	The evaluation of a novel delivery system of a sodium phosphate purge is described .\
CONCLUSIONS	Intended for use before colonoscopy , it circumvents the poor taste and excessive volume of ingestion that are aversive to patients .\
CONCLUSIONS	The tableted purgative is equally effective , safe , and greatly preferred over the existing aqueous preparations .\
CONCLUSIONS	This may improve patient compliance with recommendations for screening colonoscopy .\
\
###25863847\
OBJECTIVE	To compare macular hole ( MH ) closure and visual acuity improvement after vitrectomy using SF6 versus C3F8 gas tamponade .\
OBJECTIVE	The secondary purposes were to report the cumulative incidence of cataract development at 1 year after MH surgery and the proportion of complications .\
METHODS	Prospective , randomized study .\
METHODS	Thirty-one patients were prospectively randomized to the SF6 group and 28 patients to the C3F8 group .\
METHODS	Preoperative data included MH minimum diameter , Early Treatment Diabetic Retinopathy Study ( ETDRS ) best corrected visual acuity ( BCVA ) , cataract staging , and intraocular pressure ( IOP ) measurement .\
METHODS	Postoperative data included optical coherence tomography confirmation of the closure at 6 weeks and 1 year , and ETDRS BCVA and cataract development/extraction , both 1 year after the MH surgery .\
RESULTS	Primary MH closure was achieved in 93.3 % in the SF6 group and 92.9 % in the C3F8 group .\
RESULTS	Mean ETDRS BCVA improved by 17.7 letters in the SF6 and 16.9 letters in the C3F8 group .\
RESULTS	The difference in cumulative incidence of cataract development and extraction between both groups was not statistically significant .\
RESULTS	Regardless of the dye used , similar results were achieved .\
RESULTS	Finally , the proportion of adverse events was similar in both groups .\
CONCLUSIONS	MH surgery with SF6 gas achieves results similar to C3F8 in terms of visual acuity improvement , MH closure , cataract development/extraction , and adverse events .\
\
###25361981\
BACKGROUND	We and others have recently shown that tumor characteristics are altered throughout tumor progression .\
BACKGROUND	These findings emphasize the need for re-examination of tumor characteristics at relapse and have led to recommendations from ESMO and the Swedish Breast Cancer group .\
BACKGROUND	Here , we aim to determine whether tumor characteristics and molecular subtypes in breast cancer metastases confer clinically relevant prognostic information for patients .\
METHODS	The translational aspect of the Swedish multicenter randomized trial called TEX included 111 patients with at least one biopsy from a morphologically confirmed locoregional or distant breast cancer metastasis diagnosed from December 2002 until June 2007 .\
METHODS	All patients had detailed clinical information , complete follow-up , and metastasis gene expression information ( Affymetrix array GPL10379 ) .\
METHODS	We assessed the previously published gene expression modules describing biological processes [ proliferation , apoptosis , human epidermal receptor 2 ( HER2 ) and estrogen ( ER ) signaling , tumor invasion , immune response , and angiogenesis ] and pathways ( Ras , MAPK , PTEN , AKT-MTOR , PI3KCA , IGF1 , Src , Myc , E2F3 , and - catenin ) and the intrinsic subtypes ( PAM50 ) .\
METHODS	Furthermore , by contrasting genes expressed in the metastases in relation to survival , we derived a poor metastasis survival signature .\
RESULTS	A significant reduction in post-relapse breast cancer-specific survival was associated with low-ER receptor signaling and apoptosis gene module scores , and high AKT-MTOR , Ras , and - catenin module scores .\
RESULTS	Similarly , intrinsic subtyping of the metastases provided statistically significant post-relapse survival information with the worst survival outcome in the basal-like [ hazard ratio ( HR ) 3.7 ; 95 % confidence interval ( CI ) 1.3-10 .9 ] and HER2-enriched ( HR 4.4 ; 95 % CI 1.5-12 .8 ) subtypes compared with the luminal A subtype .\
RESULTS	Overall , 25 % of the metastases were basal-like , 32 % HER2-enriched , 10 % luminal A , 28 % luminal B , and 5 % normal-like .\
CONCLUSIONS	We show that tumor characteristics and molecular subtypes of breast cancer metastases significantly influence post-relapse patient survival , emphasizing that molecular investigations at relapse provide prognostic and clinically relevant information .\
CONCLUSIONS	CLINICALTRIALS.GOV : This is the translational part of the Swedish multicenter and randomized trial TEX , clinicaltrials.gov identifier nct01433614 ( http://www.clinicaltrials.gov/ct2/show/nct01433614 ) .\
\
###21183233\
BACKGROUND	The right ventricular ( RV ) systolic function is important for decision making in adults with repaired tetralogy of Fallot ( rTOF ) .\
BACKGROUND	Our aim was to assess regional RV systolic function and its impact on global RV systolic function by echocardiography .\
METHODS	In 101 adults with rTOF , regional RV systolic function on echocardiography was compared to 50 individuals with structurally normal hearts .\
METHODS	In patients with rTOF , the impact of echocardiographic measures of regional RV systolic function on global RV-ejection fraction as measured by cardiac magnetic resonance imaging ( CMR-RVEF ) was determined .\
RESULTS	Compared to normals , patients with rTOF had impaired systolic function of the RV outflow tract .\
RESULTS	Patients with rTOF and normal CMR-RVEF compensate this loss of RV outflow tract function with increased contractions of the RV-body , measured as fractional area change on short axis ( 3012 % versus 197 % , p < 0.0001 ) and on 4-chamber views ( 427 % versus 388 % , p = 0.06 ) .\
RESULTS	In contrast , patients with rTOF and abnormal global CMR-RVEF showed significantly lower systolic function of the RV-body compared to normal controls ( fractional area change on 4-chamber view : 316 % versus 388 % , p < 0.0001 ) .\
RESULTS	A simple regression model , incorporating fractional shortening of RV outflow tract and fractional area change on 4-chamber view allows accurate echocardiographic estimation of the CMR-derived RVEF .\
CONCLUSIONS	Patients with repaired tetralogy of Fallot have markedly different regional systolic RV-function compared to normals , even when the global RV systolic function is preserved .\
CONCLUSIONS	The systolic function of the RV outflow tract and of the RV body are both important determinants of global systolic RV function in these patients .\
CONCLUSIONS	Their prognostic significance needs to be determined .\
\
###18469260\
BACKGROUND	Probiotics and prebiotics are considered to be beneficial to the gastrointestinal health of infants .\
OBJECTIVE	The objective was to evaluate infant formulas containing probiotics and synbiotics ( combinations of probiotics and prebiotics ) for safety and tolerance .\
METHODS	In a prospective , controlled , double-blind , randomized trial , healthy full-term infants were exclusively fed a control formula or study formulas containing Bifidobacterium longum BL999 ( BL999 ) + Lactobacillus rhamnosus LPR ( LPR ) , BL999 + LPR + 4 g/L of 90 % galactooligosaccharide/10 % short-chain fructooligosaccharide ( GOS/SCFOS ) , or BL999 + Lactobacillus paracasei ST11 ( ST11 ) + 4 g/L GOS/SCFOS from < or = 2 to 16 wk of age ( treatment period ) .\
METHODS	Safety and tolerance were assessed based on weight gain during the treatment period ( primary outcome ) as well as recumbent length , head circumference , digestive tolerance , and adverse events ( secondary outcomes ) , which were evaluated at 2 , 4 , 8 , 12 , 16 , and 52 wk of age .\
RESULTS	Two hundred eighty-four infants were enrolled .\
RESULTS	During the treatment period , difference in mean weight gain between control and study formula groups in both the intention-to-treat and per-protocol populations were within the predefined equivalence boundaries of + / -3.9 g/d , indicating equivalent weight gain .\
RESULTS	Secondary outcomes did not show significant differences between groups during the treatment period .\
CONCLUSIONS	Infants fed formulas containing probiotics or synbiotics show a similar rate in weight gain compared with those fed a control formula and tolerate these formulas well .\
\
###8113846\
OBJECTIVE	To compare two published schedules of cisplatin plus fluorouracil ( 5-FU ) infusion and radiation as either sequential or concomitant treatment for toxicity and efficacy in patients with unresectable head and neck cancer .\
METHODS	This was a randomized trial between cisplatin 100 mg/m2 over 15 minutes on day 1 plus 5-FU 1.0 g/m2 by continuous infusion on days 1 to 5 , repeated every 3 weeks for three cycles , followed by 70 Gy of radiation in 7 to 8 weeks , versus cisplatin 60 mg/m2 over 15 minutes on day 1 plus 5-FU 800 mg/m2 by continuous infusion on days 1 to 5 plus radiation 2 Gy on days 1 to 5 , repeated every other week for seven cycles .\
METHODS	Unresectable head and neck squamous cancer patients not previously treated with radiation or chemotherapy and with a performance status of 0 to 2 were stratified by tumor ( T ) and node ( N ) groupings and performance status and randomized .\
RESULTS	Two hundred fifteen patients were entered and 214 analyzed , 107 on each arm .\
RESULTS	After all treatment , overall response rates were different ( P = .003 ) , with similar complete response rates , but more partial responses and fewer patients with no change or progression with concomitant treatment .\
RESULTS	Cox regression analysis for progression-free survival identified concomitant treatment ( P = .003 ) , Radiation Therapy Oncology Group ( RTOG ) stage III grouping ( P < .0001 ) , performance status ( P = .0002 ) , concomitant treatment ( P = .003 ) , and treating institution ( P = .006 ) as significant .\
RESULTS	The sequential and concomitant treatments showed similar distant failure patterns ( 10 % and 7 % , respectively ) , but divergent regional failure rates ( 55 % and 39 % ) .\
RESULTS	Severe and worse toxic events were similar between the treatment programs , but radiation-induced mucositis combined with cisplatin-induced water-losing nephropathy , in the concomitant arm only , demanded more supportive care .\
RESULTS	Survival duration was similar between the treatment arms , but significantly more patients in the sequential arm died of their cancer ( P = .011 ) .\
CONCLUSIONS	Concomitant treatment offered improved disease control , predominantly of regional disease , but benefit was dependent on the experience of the treating institution .\
CONCLUSIONS	Translation of this benefit into improved survival is not yet evident , with an excess of deaths from other causes in the concomitant arm .\
\
###25294746\
OBJECTIVE	To examine the impact of a weight loss intervention upon follicle stimulating hormone ( FSH ) levels in postmenopause .\
METHODS	Participants were postmenopausal , overweight , glucose-intolerant women not using exogenous estrogen ( n = 382 ) in the Diabetes Prevention Program .\
METHODS	Women were randomized to intensive lifestyle change ( ILS ) with the goals of weight reduction of at least 7 % of initial weight and 150 min per week of moderate-intensity exercise , metformin 850 mg twice a day , or placebo administered twice a day .\
RESULTS	Randomization to ILS led to small increases in FSH between baseline and 1-year follow-up vs. placebo ( 2.3 IU/l vs. -0.81 IU/l , P < 0.01 ) .\
RESULTS	Increases in FSH were correlated with decreases in weight ( r = -0.165 , P < 0.01 ) and estradiol ( E2 ) ( r = -0.464 , P < 0.0001 ) after adjustment for age , race/ethnicity , and randomization arm .\
RESULTS	Changes in FSH were still significantly associated with changes in weight even after adjustment for E2 levels .\
RESULTS	Metformin users had reductions in weight but non-significant changes in FSH and E2 levels vs. placebo .\
CONCLUSIONS	Weight loss leads to small increases in FSH among overweight , postmenopausal women , potentially through pathways mediated by endogenous estrogen as well as other pathways .\
\
###21708439\
OBJECTIVE	To clarify the optimal iodine dose of contrast material for 3-dimensional multidetector-row CT angiography ( 3D-MDCTA ) of the venous vasculature of the liver using volume rendering technique .\
METHODS	This study included 103 patients who were randomly assigned to 5 contrast-enhanced MDCT protocol groups with different body-weight-tailored doses of contrast material : 500 , 600 , 630 , 650 , and 700 mgI/kg body weight .\
METHODS	The arterial , portal , and hepatic parenchymal phases were obtained to evaluate enhancement values of the aorta , portal vein , and hepatic vein .\
METHODS	Visualization of the portal and hepatic veins on the volume-rendering images of 3D-MDCTA was evaluated using a 5-point grade .\
METHODS	Dunnett 's test was used to compare the mean enhancement value and mean grades of image quality ( 700 mgI/kg dose group was control ) .\
RESULTS	The mean enhancement values of portal and hepatic vein in the group with 500 and 600 mgI/kg were significantly lower than those of the control group .\
RESULTS	During visual assessment , a significantly lower mean grades were observed in 500 mgI/kg groups for the portal vein , and 500 and 600 mgI/kg groups for hepatic vein .\
RESULTS	There were no significant intergroup differences in mean enhancement values and visual assessment among the groups using 630 mgI/kg or more .\
CONCLUSIONS	Iodine doses of 630 mgI/kg was recommended for 3D-MDCTA .\
\
###22435937\
OBJECTIVE	To evaluate the association of low-density lipoprotein , high-density lipoprotein and non-high-density lipoprotein cholesterol with the risk of stroke , diabetes-related vascular events and mortality in elderly diabetes patients .\
METHODS	This study was carried out as a post-hoc landmark analysis of a randomized , controlled , multicenter , prospective intervention trial .\
METHODS	We included 1173 elderly type 2 diabetes patients ( aged 65 years ) from 39 Japanese institutions who were enrolled in the Japanese elderly diabetes intervention trial study and who could be followed up for 1 year .\
METHODS	A landmark survival analysis was carried out in which follow up was set to start 1 year after the initial time of entry .\
RESULTS	During 6 years of follow up , there were 38 cardiovascular events , 50 strokes , 21 diabetes-related deaths and 113 diabetes-related events .\
RESULTS	High low-density lipoprotein cholesterol was associated with incident cardiovascular events , and high glycated hemoglobin was associated with strokes .\
RESULTS	After adjustment for possible covariables , non-high-density lipoprotein cholesterol showed a significant association with increased risk of stroke , diabetes-related mortality and total events .\
RESULTS	The adjusted hazard ratios ( 95 % confidence intervals ) of non-high-density lipoprotein cholesterol were 1.010 ( 1.001-1 .018 , P = 0.029 ) for stroke , 1.019 ( 1.007-1 .031 , P < 0.001 ) for diabetes-related death and 1.008 ( 1.002-1 .014 ; P < 0.001 ) for total diabetes-related events .\
CONCLUSIONS	Higher non-high-density lipoprotein cholesterol was associated with an increased risk of stroke , diabetes-related mortality and total events in elderly diabetes patients .\
\
###15254494\
OBJECTIVE	To evaluate the efficacy of topical autologous serum application to stop aqueous oozing or point-leak through filtering bleb after trabeculectomy .\
METHODS	A total of 21 consecutive eyes with oozing and 21 eyes with a point-leak through a functional bleb after trabeculectomy with 5-fluorouracil or mitomycin C were enrolled in this randomized , case-control study .\
METHODS	In eyes randomly assigned to the serum group , an antibiotic and the autologous serum , which was sterilely diluted to 20 % with physiological saline , were topically applied four times a day for up to 12 weeks .\
METHODS	In eyes assigned to the control group , the antibiotic alone was applied according to the same protocol .\
METHODS	Intraocular pressure ( IOP ) and the presence of oozing or a point-leak were tested before and every 2 weeks after starting the treatments .\
RESULTS	In the serum and control groups , oozing stopped in 62.5 and 0 % of eyes , respectively ( P = 0.003 ) , and point-leaks stopped in 27.3 and 18.2 % , respectively ( P > 0.9 ) .\
RESULTS	IOP significantly increased from 10.0 + / -3.2 ( mean + / - standard deviation ) to 11.8 + / -3.3 mmHg in eyes in which oozing stopped ( P = 0.066 ) , and from 11.4 + / -2.7 to 15.4 + / -2.3 mmHg in eyes in which a point-leak stopped ( P = 0.042 ) .\
CONCLUSIONS	Autologous serum application was significantly effective to stop aqueous oozing but not point-leaks .\
CONCLUSIONS	Stopping oozing or point-leaks was significantly associated with an increase in IOP .\
\
###21436928\
OBJECTIVE	To develop and implement an elective pharmacy course in anticoagulation management and assess student learning .\
METHODS	Students participated in active-learning activities including evaluating a patient receiving outpatient or inpatient anticoagulation therapy , participating in a team project and presentation , and completing a `` living with anticoagulation '' assignment that included modeling both the health care provider 's and the patient 's role .\
RESULTS	A precourse and postcourse standardized examination on anticoagulation along with a short answer midterm and final examination were administered .\
RESULTS	Performance between precourse and postcourse examination improved by approximately 25 % , and 90 % of students scored 90 % on the final examination .\
RESULTS	Reflective narratives provided support that students found the `` living with anticoagulation '' assignment a valuable learning experience which developed empathy towards patients .\
CONCLUSIONS	An elective course in anticoagulation management that included multiple active-learning assignments was successful in increasing both students ' knowledge and empathy .\
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###22832417\
OBJECTIVE	The current study examined whether age after menopause impacted the effect of estradiol ( E2 ) on mood after a psychosocial stress manipulation .\
BACKGROUND	Previous studies have shown that E2 improves mood in women around the menopause transition but does not improve mood for older postmenopausal women .\
BACKGROUND	We have previously shown that E2 treatment in nondepressed women resulted in increased negative mood after psychosocial stress .\
METHODS	Participants were 22 postmenopausal women placed on either oral placebo or 17-estradiol ( 1 mg/day for 1 month , then 2 mg/day for 2 months ) .\
METHODS	At the end of the 3-month treatment phase , the participants performed the Trier Social Stress Test followed by mood ratings .\
METHODS	To examine the effects of age on the estrogen-stress interaction , we performed a median split on age and created four groups of participants : younger-placebo ( mean age : 55.5 years ) , younger-E2 ( mean age : 55.5 years ) , older-placebo ( mean age : 73.0 years ) , and older-E2 ( mean age : 76.8 years ) .\
RESULTS	: The results showed that both older and younger E2-treated participants exhibited a significant and similar increase in negative mood after psychosocial stress compared with placebo-treated women .\
CONCLUSIONS	These results suggest that E2 may play a significant role in modulating emotional reactivity to stressful events and that this effect persists in older women .\
CONCLUSIONS	Furthermore , responsivity to E2 effects on emotional processing appears to be intact even years after menopause in contrast with other cognitive and behavioral effects of E2 , which may be limited to the early postmenopausal years .\
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###14701887\
BACKGROUND	Out-patient services are trying to achieve effective and efficient health care in overcrowded , busy clinic settings .\
BACKGROUND	`` One stop '' and `` open access '' clinics have been advocated as a way of improving out-patient services .\
OBJECTIVE	Our aim was to evaluate the effectiveness and efficiency of a guideline-based open access urological investigation service .\
METHODS	General practices were randomized to receive either referral guidelines and access to the investigation service for lower urinary tract symptoms ( LUTS ) or referral guidelines and access to the investigation service for microscopic haematuria ( MH ) .\
METHODS	The study population comprised 66 general practices in the Grampian region of Scotland referring 959 patients .\
METHODS	The outcome measures were compliance with guidelines ( number of recommended investigations completed ) , number of general practice consultations , the number and case mix of referrals , waiting time to initial hospital appointment , and the number of patients with a management decision reached at initial appointment and discharged by 12 months after referral .\
RESULTS	GPs ' compliance with referral guidelines increased ( difference in means 0.5 ; 95 % confidence interval 0.2-0 .8 , P < 0.001 ) .\
RESULTS	Approximately 50 % of eligible patients were referred through the new system .\
RESULTS	The number and case mix of referrals were similar .\
RESULTS	The intervention reduced the waiting time from referral to initial out-patient appointment ( ratio of means 0.7 ; 0.5-0 .9 , patients with LUTS only ) and increased the number of patients who had a management decision reached at initial appointment ( odds ratio 5.8 ; 2.9-11 .5 , P < 0.00001 , both conditions ) .\
RESULTS	Patients were more likely to be discharged within 12 months ( odds ratio 1.7 ; 0.9-3 .3 , P = 0.11 ) .\
RESULTS	There were no significant changes detected in patient outcomes .\
RESULTS	Overall the new service was probably cost saving to the NHS .\
CONCLUSIONS	The guideline-based open access investigation service streamlined the process of out-patient referral , resulting in a more efficient service with reduced out-patient waiting times , fewer out-patient and investigation appointments and release of specialist and clinic time .\
\
###8791959\
BACKGROUND	The efficacy of mesalazine enemas depends on intraluminal concentration of the drug and is therefore limited by the enema distribution in the colon .\
BACKGROUND	Active ulcerative colitis changes colon motility and this leads to uncertainty about enema spread .\
OBJECTIVE	To assess the influence of disease activity on enema distribution , we conducted a physician-blinded , longitudinal study of the retrograde spread of three mesalazine enemas .\
METHODS	Thirty-one patients with mild to moderate ulcerative colitis were subdivided into three groups , and treated with 2 g mesalazine in 30 mL ( group I , n = 10 ) , 4 g mesalazine in 60 mL ( group II , n = 12 ) or 1 g mesalazine in 100 mL ( group III , n = 9 ) .\
METHODS	All patients received oral mesalazine 500 mg t.d.s. Enemas were labelled by adding 10 MBq ( 99mTc ) technetium-sulphur colloid .\
METHODS	Anterior scintigraphic images were taken at the start of the study and after 12 weeks of therapy ; retrograde spread was assessed by calculating the percentage of the enema in each colonic segment .\
RESULTS	The activity score of ulcerative colitis diminished significantly after 12 weeks of treatment , but five patients dropped out of the study .\
RESULTS	At the start of treatment enema activity in group I was mainly concentrated in the sigmoid ( 99 % ) ; in group II activity was found in the rectum ( 9 % ) , the sigmoid ( 61 % ) and the descending colon ( 15 % ) ; in group III activity was distributed between the sigmoid ( 66 % ) and descending colon ( 25 % ) .\
RESULTS	The colonic distribution of mesalazine enemas was not influenced by disease activity .\
CONCLUSIONS	Volume , but not disease activity , is the important determinant of retrograde colonic spread of mesalazine enemas in ulcerative colitis .\
\
###22974804\
OBJECTIVE	This study sought to determine the effects of a p38 mitogen-activated protein kinase inhibitor , losmapimod , on vascular inflammation , by ( 18 ) F-fluorodeoxyglucose ( FDG ) positron emission tomography/computed tomography imaging .\
BACKGROUND	The p38 mitogen-activated protein kinase cascade plays an important role in the initiation and progression of inflammatory diseases , including atherosclerosis .\
METHODS	Patients with atherosclerosis on stable statin therapy ( n = 99 ) were randomized to receive losmapimod 7.5 mg once daily ( lower dose [ LD ] ) , twice daily ( higher dose [ HD ] ) or placebo for 84 days .\
METHODS	Vascular inflammation was assessed by FDG positron emission tomography/computed tomography imaging of the carotid arteries and aorta ; analyses focused on the index vessel ( the artery with the highest average maximum tissue-to-background ratio [ TBR ] at baseline ) .\
METHODS	Serum inflammatory biomarkers and FDG uptake in visceral and subcutaneous fat were also measured .\
RESULTS	The primary endpoint , change from baseline in average TBR across all segments in the index vessel , was not significantly different between HD and placebo ( TBR : -0.04 [ 95 % confidence interval [ CI ] : -0.14 to +0.06 ] , p = 0.452 ) or LD and placebo ( TBR : -0.02 [ 95 % CI : -0.11 to +0.06 ] , p = 0.579 ) .\
RESULTS	However , there was a statistically significant reduction in average TBR in active segments ( TBR 1.6 ) ( HD vs. placebo : TBR : -0.10 [ 95 % CI : -0.19 to -0.02 ] , p = 0.0125 ; LD vs. placebo : TBR : -0.10 [ 95 % CI : -0.18 to -0.02 ] , p = 0.0194 ) .\
RESULTS	The probability of a segment being active was also significantly reduced for HD when compared with placebo ( OR : 0.57 [ 95 % CI : 0.41 to 0.81 ] , p = 0.002 ) .\
RESULTS	Within the HD group , reductions were observed in placebo-corrected inflammatory biomarkers including high-sensitivity C-reactive protein ( % reduction : -28 % [ 95 % CI : -46 to -5 ] , p = 0.023 ) as well as FDG uptake in visceral fat ( SUV : -0.05 [ 95 % CI : -0.09 to -0.01 ] , p = 0.018 ) , but not subcutaneous fat .\
CONCLUSIONS	Despite nonsignificant changes for the primary endpoint of average vessel TBR , HD losmapimod reduced vascular inflammation in the most inflamed regions , concurrent with a reduction in inflammatory biomarkers and FDG uptake in visceral fat .\
CONCLUSIONS	These results suggest a systemic anti-inflammatory effect .\
CONCLUSIONS	( A Study to Evaluate the Effects of 3 Months Dosing With GW856553 , as Assessed FDG-PET/CT Imaging ; NCT00633022 ) .\
\
###15200749\
OBJECTIVE	To present the novel design of a trial testing the safety and efficacy of a yearly bisphosponate , zoledronic acid , in preventing new clinical fractures in patients with recent low trauma hip fracture repair .\
METHODS	Randomized , placebo-controlled , triple-blind study .\
METHODS	One hundred and fifteen clinical centers worldwide are recruiting approximately 1714 subjects aged 50 years and over ( no upper age limit , median age of enrolled subjects to date 79 years ) who have undergone surgical repair of a low trauma hip fracture in the preceding 90 days .\
METHODS	Patients will be assigned at random to an intervention group ( 5 mg zoledronic acid intravenously yearly ) or a control group ( placebo infusion yearly ) .\
METHODS	Both groups receive a loading dose of Vitamin D2 or D3 IM or orally , followed by 800-1200 IU Vitamin D and 1000-1500 mg elemental calcium orally on a daily basis .\
METHODS	Concomitant therapy with calcitonin , hormone replacement therapy , selective estrogen receptor modulators , tibolone , and external hip protectors are allowed .\
METHODS	The primary endpoint is subsequent skeletal fractures as adjudicated by a clinical endpoints committee blinded to intervention status .\
METHODS	Secondary outcomes include delayed hip fracture healing , changes in bone mineral density , and health resource utilization .\
METHODS	Subjects will be recruited over a 3-4 year period and will be followed until 211 primary endpoints are accrued and adjudicated .\
CONCLUSIONS	This randomized clinical trial is novel among osteoporosis therapies as it ( 1 ) .\
CONCLUSIONS	targets hip fracture patients , a previously understudied group , and ( 2 ) .\
CONCLUSIONS	uses only clinically evident fractures as the primary outcome .\
CONCLUSIONS	Ethical and practical considerations in studying this frail population are discussed .\
\
###21623000\
OBJECTIVE	In juvenile idiopathic arthritis ( JIA ) , the efficacy of very early disease-modifying drug therapy , synthetic or biological , is not well known .\
OBJECTIVE	Three alternative strategies were compared for treating recent-onset polyarticular JIA .\
METHODS	In a 54-week multicentre open-label clinical trial , 60 disease-modifying antirheumatic drug ( DMARD ) - naive patients aged 4-15 years were randomly assigned into three treatment arms .\
METHODS	The efficacy of infliximab plus methotrexate ( TNF ) was compared to that of two synthetic therapies : methotrexate alone ( MTX ) and DMARD methotrexate , sulphasalazine and hydroxychloroquine in combination ( COMBO ) .\
METHODS	Primary endpoint was American College of Rheumatology paediatric 75 % improvement ( ACR Pedi 75 ) .\
METHODS	Secondary endpoints were inactive disease and safety .\
RESULTS	In 59 patients , mean ( SE ) age at baseline was 9.60.4 years , duration of JIA 1.90.2 months and number of active joints 181 .\
RESULTS	ACR Pedi 75 was achieved in 100 % ( 19/19 ) of patients receiving TNF , 65 % ( 13/20 ) on COMBO ( 95 % CI 44 % to 86 % ) and 50 % ( 10/20 ) on methotrexate ( 95 % CI 28 % to 72 % ) p < 0.0001 .\
RESULTS	Thirteen patients receiving TNF ( 68 % ; 95 % CI 47 % to 89 % ) achieved inactive disease , whereas eight ( 40 % ; 95 % CI 22 % to 63 % ) on COMBO and five ( 25 % ; 95 % CI 6 % to 44 % ) on methotrexate did ( p = 0.002 ) .\
RESULTS	Patients on TNF spent a mean 26 weeks ( 95 % CI 18 to 34 ) with inactive disease , longer than did those receiving COMBO ( 13 weeks ; 95 % CI 6 to 20 ) , or methotrexate ( 6 weeks ; 95 % CI 2 to 10 ) .\
RESULTS	Serious adverse events were rare .\
CONCLUSIONS	In early polyarticular JIA , targeting to achieve minimally active or inactive disease , infliximab plus methotrexate was superior to synthetic DMARD in combination and strikingly superior to methotrexate alone .\
\
###18371557\
OBJECTIVE	We examined the ESCAPE ( Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness ) database to understand the impact and pathophysiology of renal dysfunction in patients hospitalized with advanced decompensated heart failure ( HF ) .\
BACKGROUND	Baseline renal insufficiency ( RI ) ( estimated glomerular filtration rate [ eGFR ] < 60 ml/min ) and worsening renal function ( WRF ) ( upward arrow serum creatinine [ SCr ] > or = 0.3 mg/dl ) during treatment of decompensated HF are associated with adverse outcomes .\
METHODS	We used a Cox proportional hazards model to evaluate the impact of renal function on 6-month outcomes .\
METHODS	Renal parameters were correlated with hemodynamic measurements .\
METHODS	The impact of a strategy using pulmonary artery catheter ( PAC ) guidance on WRF and outcomes in patients with baseline RI was compared with treatment based on clinical assessment alone .\
RESULTS	Baseline and discharge RI , but not WRF , were associated with an increased risk of death and death or rehospitalization .\
RESULTS	Among the hemodynamic parameters measured in patients randomized to the PAC arm ( n = 194 ) , only right atrial pressure correlated weakly with baseline SCr ( r = 0.165 , p = 0.03 ) .\
RESULTS	There was no correlation between baseline hemodynamics or change in hemodynamics and WRF .\
RESULTS	A PAC-guided strategy was associated with less average increase in creatinine but did not decrease the incidence of defined WRF during hospitalization or affect renal function after discharge relative to clinical assessment alone .\
CONCLUSIONS	Among patients with advanced decompensated HF , baseline RI impacts outcomes more than WRF .\
CONCLUSIONS	Poor forward flow alone does not appear to account for the development of RI or WRF in these patients .\
CONCLUSIONS	The addition of hemodynamic monitoring to clinical assessment does not prevent WRF or improve renal function after discharge .\
\
###7974588\
OBJECTIVE	Three different methods for estimating the percentage of reduction in the diameter of the internal carotid artery ( ie , stenosis ) have been proposed in the literature .\
OBJECTIVE	Further comparisons of the methods were carried out with the intent of recommending a current standard for determining the percentage of stenosis from angiograms .\
METHODS	Angiograms from 112 patients were obtained .\
METHODS	For each angiogram , stenosis was estimated in the manner of the European Carotid Surgery Trial ( ECST method ) , the North American Symptomatic Carotid Endarterectomy Trial ( NASCET method ) , and by a method using the common carotid artery lumen diameter ( CC method ) .\
RESULTS	Although there is much discrepancy among the estimates of stenosis arising from the three different methods for any particular patient , it is possible to predict ( on average ) the percentage of stenosis from one method to another .\
RESULTS	The relationship between the NASCET and CC methods is linear , with a mean ratio of distal internal carotid artery to common carotid diameter of 0.62 ( SD of 0.11 ) .\
RESULTS	The variability in the diameter of the common carotid artery lumen stabilizes only beyond 2.5 common carotid diameter units ( approximately 20 to 30 mm by conventional angiography ) proximal to the bifurcation .\
RESULTS	Unexpectedly , the relationships between both the ECST and NASCET methods and ECST and CC methods were parabolic ( P < .001 ) .\
RESULTS	The reasons underlying these departures from linearity are uncertain .\
CONCLUSIONS	The comparability of our results with those reported in the literature regarding the CC and NASCET methods provides further evidence of the reproducibility of methods measuring anatomic features that can be visualized on an angiogram .\
CONCLUSIONS	Disease of the internal carotid artery is one of the important causes of ischemic symptoms .\
CONCLUSIONS	Measuring the narrowest portion of the internal artery relative to the normal portion of the same artery , well beyond the bulb , is a logical method .\
CONCLUSIONS	Moreover , benefits of carotid endarterectomy for patients with 70 % to 99 % stenosis as determined by the NASCET method have been well established in a clinical trial .\
CONCLUSIONS	Converting from the NASCET method to the CC method , given that the CC method is neither superior nor easier to calculate , is not recommended .\
\
###10028979\
BACKGROUND	Transmyocardial laser revascularisation ( TMLR ) is used to treat patients with refractory angina due to severe coronary artery disease , not suitable for conventional revascularisation .\
BACKGROUND	We aimed in a randomised controlled trial to assess the effectiveness of TMLR compared with medical management .\
METHODS	188 patients with refractory angina were randomly assigned TMLR plus normal medication or medical management alone .\
METHODS	At 3 months , 6 months , and 12 months after surgery ( TMLR ) or initial assessment ( medical management ) we assessed exercise capacity with the treadmill test and the 12 min walk .\
RESULTS	Mean treadmill exercise time , adjusted for baseline values , was 40 s ( 95 % CI -15 to 94 ) longer in the TMLR group than in the medical-management group at 12 months ( p = 0.152 ) .\
RESULTS	Mean 12 min walk distance was 33 m ( -7 to 74 ) further in TMLR patients than medical-management patients ( p = 0.108 ) at 12 months .\
RESULTS	The differences were not significant or clinically important .\
RESULTS	Perioperative mortality was 5 % .\
RESULTS	Survival at 12 months was 89 % ( 83-96 ) in the TMLR group and 96 % ( 92-100 ) in the medical-management group ( p = 0.14 ) .\
RESULTS	Canadian Cardiovascular Society score for angina had decreased by at least two classes in 25 % of TMLR and 4 % of medical-management patients at 12 months ( p < 0.001 ) .\
CONCLUSIONS	Our findings show that the adoption of TMLR can not be advocated .\
CONCLUSIONS	Further research may be appropriate to assess any potential benefit for sicker patients .\
\
###18047609\
BACKGROUND	Kinetin and niacinamide are used in the cosmetic industry as anti-aging agents .\
BACKGROUND	Neither the interactive/additive effects of these compounds nor the anti-aging efficacy on Asian skin has been studied .\
BACKGROUND	Objective To assess the clinical anti-aging effects and efficacy differences between kinetin plus niacinamide and niacinamide alone vs. vehicle placebo in an Asian cohort .\
METHODS	Fifty-two Taiwanese subjects were enrolled in a randomized , double-blind , placebo-controlled , split-face comparative study .\
METHODS	Group 1 subjects were treated with kinetin 0.03 % plus niacinamide 4 % , whereas group 2 subjects received niacinamide 4 % .\
METHODS	The treatment formulation was applied on one side of the face , whereas a placebo was applied on the other for a period of 12 weeks .\
METHODS	We used noninvasive biometrological instruments to evaluate a variety of skin parameters at baseline and at weeks 4 , 8 , and 12 .\
RESULTS	Persistent and significant reductions in spot , pore , wrinkle , and evenness counts were found at weeks 8 and 12 in group 1 .\
RESULTS	A significant increase in corneal hydration status was also evident at week 12 , whereas persistent decreases in erythema index were apparent at 8 and 12 weeks .\
RESULTS	In group 2 , significant reductions in pore and evenness counts at week 8 and wrinkle counts at week 12 were noted .\
CONCLUSIONS	We found kinetin and niacinamide exert a synergistic anti-aging effect .\
CONCLUSIONS	Our data suggest that these compounds have multiactive , multifunctional , and pluripotent effects on skin .\
CONCLUSIONS	They are also both promising to be included in the cutaneous anti-aging cosmeceuticals in the future .\
\
###18753005\
BACKGROUND	A double-blind , placebo-controlled sodium oxybate trial provided a unique opportunity to compare changes in cataplexy following gradual withdrawal from antidepressants in narcolepsy patients .\
METHODS	Of 228 enrolled patients , 71 discontinued antidepressant therapy .\
METHODS	Data from 57 patients were available for analysis : 37 patients discontinued tricyclic antidepressants ( TCAs ) and 20 discontinued selective serotonin reuptake inhibitors ( SSRIs ) .\
METHODS	The trial included a 21-day withdrawal phase followed by 18-day washout and 14-day single-blind treatment phases .\
METHODS	Two additional weeks were permitted for withdrawal from fluoxetine due to its long half-life .\
METHODS	Weekly cataplexy attacks were recorded throughout the trial .\
METHODS	No historical data on the frequency of cataplexy prior to treatment with antidepressants was available .\
RESULTS	Among the patients who were and were not withdrawn from antidepressants treatment , the median frequency of baseline weekly cataplexy was similar ( 17.5 vs. 14.0 , respectively ) .\
RESULTS	As expected , significant between-group differences emerged by the end of the washout period ( 52.04 vs. 15.25 , respectively ; p < 0.05 ) ; however , the frequency of cataplexy events became similar again by the end of the trial ( 16.5 vs. 17.5 , respectively ) .\
CONCLUSIONS	Patients gradually withdrawn from antidepressants experienced a significant increase in cataplexy , but eventually returned to their baseline frequency , comparable to previously untreated control patients .\
CONCLUSIONS	Compared to SSRIs , discontinuation from TCAs was associated with a greater increase in cataplexy attacks .\
\
###21067382\
BACKGROUND	Early exposure to complex dietary proteins may increase the risk of beta-cell autoimmunity and type 1 diabetes in children with genetic susceptibility .\
BACKGROUND	We tested the hypothesis that supplementing breast milk with highly hydrolyzed milk formula would decrease the cumulative incidence of diabetes-associated autoantibodies in such children .\
METHODS	In this double-blind , randomized trial , we assigned 230 infants with HLA-conferred susceptibility to type 1 diabetes and at least one family member with type 1 diabetes to receive either a casein hydrolysate formula or a conventional , cow 's - milk-based formula ( control ) whenever breast milk was not available during the first 6 to 8 months of life .\
METHODS	Autoantibodies to insulin , glutamic acid decarboxylase ( GAD ) , the insulinoma-associated 2 molecule ( IA-2 ) , and zinc transporter 8 were analyzed with the use of radiobinding assays , and islet-cell antibodies were analyzed with the use of immunofluorescence , during a median observation period of 10 years ( mean , 7.5 ) .\
METHODS	The children were monitored for incident type 1 diabetes until they were 10 years of age .\
RESULTS	The unadjusted hazard ratio for positivity for one or more autoantibodies in the casein hydrolysate group , as compared with the control group , was 0.54 ( 95 % confidence interval [ CI ] , 0.29 to 0.95 ) , and the hazard ratio adjusted for an observed difference in the duration of exposure to the study formula was 0.51 ( 95 % CI , 0.28 to 0.91 ) .\
RESULTS	The unadjusted hazard ratio for positivity for two or more autoantibodies was 0.52 ( 95 % CI , 0.21 to 1.17 ) , and the adjusted hazard ratio was 0.47 ( 95 % CI , 0.19 to 1.07 ) .\
RESULTS	The rate of reported adverse events was similar in the two groups .\
CONCLUSIONS	Dietary intervention during infancy appears to have a long-lasting effect on markers of beta-cell autoimmunity -- markers that may reflect an autoimmune process leading to type 1 diabetes .\
CONCLUSIONS	( ClinicalTrials.gov number , NCT00570102 . )\
\
###15601351\
BACKGROUND	The study objective was to compare epidural vs intravenous postoperative analgesia in posterior spinal fusion surgery patients .\
METHODS	This prospective , double-blinded , randomized study was performed in a tertiary care teaching hospital involving 31 American Society of Anesthesiologists physical status I and II adolescent/young adult patients scheduled for elective posterior spinal fusion surgery for idiopathic scoliosis .\
METHODS	Patients were divided into three treatment groups according to the epidural solution infused : group 1 ( n = 10 ) 0.1 % bupivacaine + 5 microg x ml ( -1 ) fentanyl ; group 2 ( n = 12 ) 0.0625 % bupivacaine + 5 microg x ml ( -1 ) fentanyl ; group 3 ( n = 9 ) 0.9 % sodium chloride ( placebo ) .\
METHODS	During general anesthesia all patients received a directly placed midthoracic epidural catheter with a set infusion rate followed by morphine sulfate intravenous patient-controlled analgesic device postoperatively .\
METHODS	Morphine sulfate usage and visual analog scores were evaluated at 4 h intervals postoperatively for up to 96 h. Postoperative time to liquids , solid food , ambulation , length of stay , discontinuation of Foley catheter , and side effects were recorded .\
RESULTS	No consistent difference was detected on intravenous morphine dose usage , visual analog scores , or estimated pain scale over the whole follow-up period .\
RESULTS	No difference was observed in the epidural groups in time to oral intake of liquids or solids , ambulation , bowel sounds , or length of stay when compared with placebo .\
CONCLUSIONS	By evaluating morphine sulfate usage between groups , the analgesic effectiveness of continuous thoracic epidural analgesia bupivacaine and fentanyl doses used revealed no significant improvement over intravenous morphine sulfate analgesia alone in patients after posterior spinal fusion surgery .\
\
###11859658\
BACKGROUND	There has been a great deal of discussion regarding the necessity of antibiotic prophylaxis in transurethral cystoscopy .\
BACKGROUND	In order to clarify this complicated issue , a randomized prospective study was performed on 126 patients planned for cystoscopy .\
METHODS	126 patients who underwent urethrocystoscopy and did not have pyuria and bacteriuria were included and divided randomly into 2 groups : group 1 received 400 mg of norfloxacine and group 2 nothing .\
METHODS	Urinalysis were performed on all patients 3 days after the examination .\
METHODS	Statistical analyses were performed using Chi 2 test and the level of significance was set at 5 % .\
RESULTS	The global rate of infection was 5 % .\
RESULTS	In the group 1 the incidence of infection was 3 % ( 2/67 ) vs 5.1 % ( 5/59 ) in group 2 .\
RESULTS	There were no significant differences in the incidence in the background factor between the 2 groups of patients ( p > 0.05 ) .\
CONCLUSIONS	Prophylactic administration of antibiotic before cystoscopy does not decrease the incidence of urinary tract incidence and it is not necessarily in patients with sterile urine .\
\
###20177797\
BACKGROUND	The aim of this study was to evaluate Ki-67 and Bcl-2 antigen expression in colorectal polyps from women with breast cancer .\
METHODS	A randomized , controlled study was carried out in 35 women , either with or without breast cancer , who had adenomatous colorectal polyps .\
METHODS	The patients were divided into two groups : group A ( without breast cancer ; control group ; n = 17 ) and group B ( with breast cancer ; study group ; n = 18 ) .\
METHODS	Immunohistochemistry was performed on the colorectal polyps to evaluate Ki-67 and Bcl-2 antigen expression .\
METHODS	Student 's t-test and the chi ( 2 ) test were used for the statistical analysis of Ki-67 and Bcl-2 expression , respectively .\
METHODS	Statistical significance was established as P < 0.05 .\
RESULTS	The mean percentage of Ki-67-stained nuclei in groups A and B was 36.25 + / - 2.31 and 59.44 + / - 3.34 ( + / - SEM ) , respectively ( P < 0.0001 ) , while the percentage of cases with cells expressing Bcl-2 in groups A and B was 23.5 and 77.8 % , respectively ( P < 0.001 ) .\
CONCLUSIONS	In the present study , there was greater proliferative activity and greater expression of the antiapoptotic protein Bcl-2 in the colorectal polyps of women with breast cancer .\
\
###18242535\
BACKGROUND	Current atrial fibrillation ( AF ) ablation involves isolation of all pulmonary veins ( PVs ) with or without additional linear lesions .\
BACKGROUND	However , whether such extensive ablation is necessary is unclear .\
OBJECTIVE	The purpose of this study was to assess the efficacy of different ablation strategies on long-term AF control .\
METHODS	We prospectively randomized patients to undergo isolation of all versus arrhythmogenic PVs ( identified by standardized stimulation protocol ) .\
METHODS	PV isolation was guided by circular mapping catheter .\
METHODS	The endpoint was entry/exit block persisting for > or = 20 minutes .\
METHODS	Patients were evaluated at three clinic visits ( at 6 weeks , 6 months , and 1 year ) and multiple transtelephonic monitoring periods .\
METHODS	Antiarrhythmic drugs were discontinued at 6 weeks .\
METHODS	Primary study endpoint was long-term AF control ( freedom or > 90 % reduction in AF burden off or on previously ineffective antiarrhythmic drugs at 1 year after a single ablation procedure ) .\
RESULTS	Over a 20-month period , 105 patients ( 76 men and 29 women , age 57 + / - 9 years ; paroxysmal AF = 77 ) were randomized , and 103 patients completed 1-year follow-up ( 51 patients in all-PV arm , 52 patients in arrhythmogenic PV arm ) .\
RESULTS	The primary endpoint was achieved in 75 ( 73 % ) patients and was similar in patients randomized to all-PV arm versus arrhythmogenic PV arm [ 38 ( 75 % ) patients vs 37 ( 71 % ) patients , respectively ; odds ratio 1.18 , 95 % confidence interval 0.50 , 2.83 , P = .70 ] .\
RESULTS	Secondary study endpoints , including freedom from AF off antiarrhythmic drugs , total procedure/fluoroscopy times , and occurrence of serious adverse events , were not different between the two groups .\
CONCLUSIONS	In a randomized comparison , isolation of arrhythmogenic veins was as efficacious as empiric isolation of all veins in achieving long-term AF control .\
\
###24854809\
BACKGROUND	Emotional eating is associated with overeating and the development of obesity .\
BACKGROUND	Yet , empirical evidence for individual ( trait ) differences in emotional eating and cognitive mechanisms that contribute to eating during sad mood remain equivocal .\
OBJECTIVE	The aim of this study was to test if attention bias for food moderates the effect of self-reported emotional eating during sad mood ( vs neutral mood ) on actual food intake .\
OBJECTIVE	It was expected that emotional eating is predictive of elevated attention for food and higher food intake after an experimentally induced sad mood and that attentional maintenance on food predicts food intake during a sad versus a neutral mood .\
METHODS	Participants ( N = 85 ) were randomly assigned to one of the two experimental mood induction conditions ( sad/neutral ) .\
METHODS	Attentional biases for high caloric foods were measured by eye tracking during a visual probe task with pictorial food and neutral stimuli .\
METHODS	Self-reported emotional eating was assessed with the Dutch Eating Behavior Questionnaire ( DEBQ ) and ad libitum food intake was tested by a disguised food offer .\
RESULTS	Hierarchical multivariate regression modeling showed that self-reported emotional eating did not account for changes in attention allocation for food or food intake in either condition .\
RESULTS	Yet , attention maintenance on food cues was significantly related to increased intake specifically in the neutral condition , but not in the sad mood condition .\
CONCLUSIONS	The current findings show that self-reported emotional eating ( based on the DEBQ ) might not validly predict who overeats when sad , at least not in a laboratory setting with healthy women .\
CONCLUSIONS	Results further suggest that attention maintenance on food relates to eating motivation when in a neutral affective state , and might therefore be a cognitive mechanism contributing to increased food intake in general , but maybe not during sad mood .\
\
###18978501\
OBJECTIVE	To study possible psychopathological symptoms and cognitive deficits , abuse induction , as well as general tolerability and effects on quality of life , fatigue and motor function in cannabis-nave patients with multiple sclerosis ( MS ) treated with a free-dose cannabis plant extract ( Sativex ) .\
METHODS	In an 8-week , randomized , double-blind , placebo-controlled , parallel group crossover trial , 17 cannabis-nave patients with MS were assessed at baseline and at the end of the cannabis and placebo phases of the trial ( each of 3 weeks ) by means of Symptom Checklist-90 Revised , Self-rating Anxiety Scale , Multiple Sclerosis Functional Composite ( of which 1 dimension is the Paced Auditory Serial Additional Test that was used to evaluate cognition ) , Visual Analogue Scale on health-related quality of life , Multiple Sclerosis Impact Scale-29 , and Fatigue Severity Scale .\
RESULTS	Postplacebo versus postcannabinoid scores showed that no significant differences could be detected on all the variables under study .\
RESULTS	A significant positive correlation was found between Delta-9-tetrahydrocannabinol blood levels and scores at the General Symptomatic Index and at the `` interpersonal sensitivity , '' `` aggressive behaviour , '' and `` paranoiac tendencies '' subscales of the Symptom Checklist-90 Revised .\
RESULTS	No serious adverse events , abuse tendencies , or direct withdrawal symptoms were reported .\
RESULTS	Increased desire for Sativex with secondary depression was reported in 1 subject .\
CONCLUSIONS	Cannabinoid treatment did not induce psychopathology and did not impair cognition in cannabis-nave patients with MS. However , the positive correlation between blood levels of Delta-9-tetrahydrocannabinol and psychopathological scores suggests that at dosages higher than those used in therapeutic settings , interpersonal sensitivity , aggressiveness , and paranoiac features might arise , although greater statistical power would be necessary to confirm this finding .\
\
###9219787\
OBJECTIVE	To assess the efficacy of a combination of oral and topical 5-aminosalicylic acid ( 5-ASA ) for the maintenance treatment of ulcerative colitis , we undertook a double-blind randomized clinical trial .\
METHODS	Patients aged 18 to 65 yr ( with disease extent greater than proctitis only ) were eligible for inclusion in the study if they met the following criteria : ( a ) history of two or more relapses in the last year ; ( b ) achievement of remission in the last 3 months ( with maintenance of remission for at least 1 month ) .\
METHODS	Patients enrolled in the study were randomly assigned to one of the two following 1-yr treatments : ( 1 ) combined therapy with 5-ASA tablets 1.6 g/day and 5-ASA enemas 4 g/100 ml twice weekly ; ( 2 ) oral therapy with 5-ASA tablets 1.6 g/day and placebo enemas/twice weekly .\
METHODS	The main end point of the study was the maintenance of remission at 12 months .\
RESULTS	Upon completion of the study , relapse occurred in 13 of 33 patients in the combined treatment group versus 23 of 36 patients in the oral treatment group ( 39 vs 69 % ; p = 0.036 ) .\
RESULTS	No significant side effects related to treatment were observed in either group .\
RESULTS	A simplified pharmacoeconomic analysis shows that this form of combined treatment can have a favorable cost-effectiveness ratio .\
CONCLUSIONS	Our results indicate that 5-ASA given daily by oral route and intermittently by topical route can be more effective than oral therapy alone .\
CONCLUSIONS	This form of combination treatment can be appropriate for patients at high risk of relapse .\
\
###22051739\
BACKGROUND	Vaginal self-sampling for human papillomavirus ( HPV ) DNA testing could increase rates of screening participation .\
BACKGROUND	In clinic-based settings , vaginal HPV testing is at least as sensitive as cytology for detecting cervical intraepithelial neoplasia ( CIN ) grade 2 or worse ; however , effectiveness in home settings is unknown .\
BACKGROUND	We aimed to establish the relative sensitivity and positive predictive value for HPV screening of vaginal samples self-collected at home as compared with clinic-based cervical cytology .\
METHODS	We did a community-based , randomised equivalence trial in Mexican women of low socioeconomic status aged 25-65 years .\
METHODS	Participants came from 540 medically underserved , predominantly rural communities in Morelos , Guerrero , and the state of Mexico .\
METHODS	Our primary endpoint was CIN 2 or worse , detected by colposcopy .\
METHODS	We used a computer-generated randomisation sequence to randomly allocate patients to HPV screening or cervical cytology .\
METHODS	Eight community nurses who were masked to patient allocation received daily lists of the women 's names and addresses , and did the assigned home visits .\
METHODS	We referred women with positive results in either test to colposcopy .\
METHODS	We did per-protocol and intention-to-screen analyses .\
METHODS	This trial was registered with the Instituto Nacional de Salud Pblica , Mexico , INSP number 590 .\
RESULTS	12,330 women were randomly allocated to HPV screening and 12,731 to cervical cytology ; 9202 women in the HPV screening group adhered to the protocol , as did 11,054 in the cervical cytology group .\
RESULTS	HPV prevalence was 98 % ( 95 % CI 91-104 ) and abnormal cytology rate was 038 % ( 023-045 ) .\
RESULTS	HPV testing identified 1174 women with CIN 2 or worse per 10,000 ( 952-1395 ) compared with 344 women with CIN 2 or worse per 10,000 ( 234-453 ) identified by cytology ; the relative sensitivity of HPV testing was 34 times greater ( 24-49 ) .\
RESULTS	Similarly , HPV testing detected 42 times ( 19-92 ) more invasive cancers than did cytology ( 304 per 10,000 [ 191-417 ] vs 72 per 10,000 [ 22-123 ] ) .\
RESULTS	The positive predictive value of HPV testing for CIN 2 or worse was 122 % ( 99-145 ) compared with 905 % ( 617-100 ) for cytology .\
CONCLUSIONS	Despite the much lower positive predictive value for HPV testing of self-collected vaginal specimens compared with cytology , such testing might be preferred for detecting CIN 2 or worse in low-resource settings where restricted infrastructure reduces the effectiveness of cytology screening programmes .\
CONCLUSIONS	Because women at these sites will be screened only a few times in their lives , the high sensitivity of a HPV screen is of paramount importance .\
BACKGROUND	Instituto Nacional de Salud Pblica , the Health Ministry of Mexico , QiAGEN Corp. .\
\
###19826646\
OBJECTIVE	Several combination endoscopic therapies are currently in use .\
OBJECTIVE	The present study aimed to compare argon plasma coagulation ( APC ) + adrenaline injection ( AI ) with hemoclips + AI for the treatment of high-risk bleeding peptic ulcers .\
METHODS	In a prospective randomized trial , 172 patients with major stigmata of peptic ulcer bleeding were randomly assigned to receive APC + AI ( n = 89 ) or hemoclips + AI ( n = 83 ) .\
METHODS	In the event of rebleeding , the initial modality was used again .\
METHODS	Patients in whom treatment or retreatment was unsuccessful underwent emergency surgery .\
METHODS	The primary end point of rebleeding rate and secondary end points of initial and definitive hemostasis need for surgery and mortality were compared between the two groups .\
RESULTS	The two groups were similar in all background variables .\
RESULTS	Definitive hemostasis was achieved in 85 of 89 ( 95.5 % ) of the APC + AI and 82 of 83 ( 98.8 % ) of the hemoclips + AI group ( P = 0.206 ) .\
RESULTS	The mean volume of adrenaline injected in the two groups was equal ( 20.7 mL ; P = 0.996 ) .\
RESULTS	There was no significant difference in terms of initial hemostasis ( 96.6 % versus 98.8 % ; P = 0.337 ) , rate of rebleeding ( 11.2 % versus 4.8 % ; P = 0.124 ) , need for surgery ( 4.5 % versus 1.2 % ; P = 0.266 ) and mortality ( 2.2 % versus 1.2 % ; P = 0.526 ) .\
RESULTS	When compared for the combined end point of mortality plus rebleeding and the need for surgery , there was an advantage for the hemoclip group ( 6 % versus 15.7 % , P = 0.042 ) .\
CONCLUSIONS	Hemoclips + AI has no superiority over APC + AI in treating patients with high-risk bleeding peptic ulcers .\
CONCLUSIONS	Hemoclips + AI may be superior when a combination of all negative outcomes is considered .\
\
###15732545\
OBJECTIVE	This study evaluated the ability of a new polyvinyl siloxane impression material ( Affinis , Coltne/Whaledent , material A ) to obtain final impressions free of bubbles and voids for indirect fixed cuspal-coverage restorations .\
OBJECTIVE	The results were compared to a control polyvinyl siloxane impression material ( material B ) .\
OBJECTIVE	Both materials were handled by inexperienced clinicians ( undergraduate dental students ) in student clinics .\
METHODS	One-hundred and thirty patients who were treated in the Louisiana State University School of Dentistry Junior Student Clinic for indirect fixed cuspal-coverage restorations and who met the inclusion criteria were randomly assigned to either one of two treatment groups , group A ( n = 65 ) or group B ( n = 65 ) .\
METHODS	Two calibrated examiners evaluated the first impression of prepared posterior teeth at a magnification of 10x for acceptability ( no voids or bubbles ) .\
METHODS	Position of tooth , type of preparation , preparation finish line ( Class I-V ) , and gingival bleeding scores were recorded .\
METHODS	All statistical tests were performed with the level of significance set at .05 .\
RESULTS	The Fisher-Freeman-Halton test did not reveal significant associations between material and gingival bleeding score ( P = .492 ) .\
RESULTS	Significant differences in the location of the preparation finish line between materials were observed ( P = .0096 ) ; material A was more frequently used in cases where the preparation finish line was located at least 2 mm subgingivally .\
RESULTS	Logistic regression was used to assess the effect of the material on the success of the impression ( acceptable / unacceptable ) .\
RESULTS	Material was highly significant in the logistic model ( P < .001 ) with an odds in favor of an acceptable impression being eight times higher with material A than with material B ( odds ratio = 8.00 ; 95 % confidence index for odds ratio : 2.832 , 22.601 ) .\
RESULTS	The 60/65 ( 92.3 % ) impressions made with material A and 39/65 ( 60 % ) impressions made with material B were rated `` acceptable . ''\
CONCLUSIONS	The new polyvinyl siloxane impression material provided a significantly higher proportion of impressions free of bubbles and voids than the control polyvinyl siloxane material .\
\
###11975938\
BACKGROUND	Cancer-related cachexia is caused by a diverse combination of accelerated protein breakdown and slowed protein synthesis .\
BACKGROUND	The hypothesis proposed in this study is that supplementation of specific nutrients known to positively support protein synthesis and reduce protein breakdown will reverse the cachexia process in advanced cancer patients .\
METHODS	Patients with solid tumors who had demonstrated a weight loss of at least 5 % were considered for the study .\
METHODS	Patients were randomly assigned in a double-blind fashion to either an isonitrogenous control mixture of nonessential amino acids or an experimental treatment containing beta-hydroxy-beta-methylbutyrate ( 3 g/d ) , L-arginine ( 14 g/d ) , and L-glutamine ( 14 g/d [ HMB/Arg/Gln ] ) .\
METHODS	The primary outcomes measured were the change in body mass and fat-free mass ( FFM ) , which were assessed at 0 , 4 , 8 , 12 , 16 , 20 , and 24 weeks .\
RESULTS	Thirty-two patients ( 14 control , 18 HMB/Arg/Gln ) were evaluated at the 4-week visit .\
RESULTS	The patients supplemented with HMB/Arg/Gln gained 0.95 + / - 0.66 kg of body mass in 4 weeks , whereas control subjects lost 0.26 + / - 0.78 kg during the same time period .\
RESULTS	This gain was the result of a significant increase in FFM in the HMB/Arg/Gln-supplemented group ( 1.12 + / - 0.68 kg ) , whereas the subjects supplemented with the control lost 1.34 + / - 0.78 kg of FFM ( P = 0.02 ) .\
RESULTS	The response to 24-weeks of supplementation was evaluated by an intent-to-treat statistical analysis .\
RESULTS	The effect of HMB/Arg/Gln on FFM increase was maintained over the 24 weeks ( 1.60 + / - 0.98 kg ; quadratic contrast over time , P < 0.05 ) .\
RESULTS	There was no negative effect of treatment on the incidence of adverse effects or quality of life measures .\
CONCLUSIONS	The mixture of HMB/Arg/Gln was effective in increasing FFM of advanced ( stage IV ) cancer .\
CONCLUSIONS	The exact reasons for this improvement will require further investigation , but could be attributed to the observed effects of HMB on slowing rates of protein breakdown , with improvements in protein synthesis observed with arginine and glutamine .\
\
###18164988\
OBJECTIVE	The purpose of this study was to study the effect of attention and sustained silence on the emergence of auditory phantom perception in normal-hearing adults .\
METHODS	Cross-sectional survey .\
METHODS	While sitting in a sound booth , 66 volunteers ( age range , 18-65 ; mean age , 37.3 ) performed 3 experiments of 5 minutes each , consecutively and randomly presented .\
METHODS	Two deviated attention from auditory system ( Hanoi and visual attention experiments ) , and 1 drove attention to the auditory system ( auditory attention ) .\
METHODS	After each experiment , participants were asked about their auditory and visual perception .\
METHODS	No sound or light change was given at any moment .\
RESULTS	Of the participants , 19.7 % experienced tinnitus during Hanoi , 45.5 % during visual attention , and 68.2 % during auditory attention experiment , with no significant differences for studied variables .\
CONCLUSIONS	Tinnitus-like perceptions may occur in a nonclinical population in a silent environment .\
CONCLUSIONS	Concomitant auditory attention plays an important role on the emergence of tinnitus .\
\
###23524622\
OBJECTIVE	Papaya ( Carica papaya L. ) is used as a natural remedy in abnormal digestion in tropical and industrialized countries .\
OBJECTIVE	Besides this wide distribution little evidence has been produced with reference to its physiological effect in humans and the proof of efficacy .\
OBJECTIVE	Former clinical observations had revealed positive effects for patients with constipation , heartburn , and symptoms of irritable bowel syndrome ( IBS ) after eating papaya preparations .\
OBJECTIVE	In line with these former positive clinical observations , we studied the clinical effects of the papaya preparation Caricol in a double blind placebo controlled study design .\
METHODS	In this study the participants were volunteers , with chronic ( prevailing ) indigestions and dysfunctions in the gastrointestinal tract .\
METHODS	During the trial the intake of the substance of intent and placebo was 20 ml daily for 40days .\
METHODS	The endpoints were the frequency of 22 symptoms recorded before and after the documented intake recorded by questionnaire .\
RESULTS	The symptoms `` Constipation '' , `` Bloating '' , and `` Heartburn '' were defined as primary and frequency of `` painful ( straining ) bowel movements '' as secondary endpoint .\
RESULTS	The participation ended after the intake period within two days ( `` early returnees '' ) .\
RESULTS	Wash out effects were observed in `` late returnees '' , who returned with a delay of 8.6 ( 5.95 days ) .\
RESULTS	In the verum group early returnees revealed statistically significant improvements of the symptoms `` constipation '' and `` bloating '' .\
RESULTS	The analysis of `` heartburn '' felt short of significant improvement because of the small number of included cases with this criteria ( N = 13 , p = 0.114 ) .\
RESULTS	None of the significant benefits were observed after the washout phase .\
CONCLUSIONS	We conclude from these results , that the papaya preparation ( Caricol ) contributes to the maintenance of digestive tract physiology .\
CONCLUSIONS	It ameliorates various functional disturbances , like symptoms of IBS .\
CONCLUSIONS	The mechanism of this digestive tract physiology support is discussed .\
\
###24322182\
OBJECTIVE	This study aims to investigate the efficacy and safety of oral fixed-dose combination of strontium ranelate 2 g/vitamin D 1000 IU daily vs strontium ranelate 2 g daily for correcting vitamin D insufficiency in osteoporosis .\
METHODS	A 6-month international , randomized , double-blind , parallel-group , phase 3 study .\
METHODS	A total of 518 men and postmenopausal women aged 50 years with primary osteoporosis ( T-score -2.5 s.d. ) and serum 25-hydroxyvitamin D ( 25 ( OH ) D ) > 22.5 nmol/l were included .\
METHODS	Patients were allocated to strontium ranelate 2 g/vitamin D 1000 IU daily ( n = 413 ) or strontium ranelate 2 g daily ( n = 105 ) .\
METHODS	The participants received calcium 1 g daily .\
METHODS	The primary endpoint was serum 25 ( OH ) D at last post-baseline evaluation during 3 months .\
RESULTS	Both groups were comparable at baseline .\
RESULTS	Mean baseline of 25 ( OH ) D was 44.1 14.6 nmol/l .\
RESULTS	After 3 months , the percentage of patients with 25 ( OH ) D 50 nmol/l was higher with strontium ranelate/vitamin D vs strontium ranelate ( 84 vs 44 % , P < 0.001 ; adjusted between-group odds ratio = 6.7 ; 95 % CI , 4.2-10 .9 ) .\
RESULTS	The efficacy of the fixed-dose combination on 25 ( OH ) D was maintained at 6 months ( 86 vs 40 % , P < 0.001 ) .\
RESULTS	Mean 25 ( OH ) D was 65.1 and 49.5 nmol/l , respectively , after 3 months and 66.9 and 45.4 nmol/l after 6 months .\
RESULTS	Physical performance improved in both groups .\
RESULTS	Falls were 17 and 20 % in the strontium ranelate/vitamin D and strontium ranelate groups respectively .\
RESULTS	Parathyroid hormone levels were inversely correlated with 25 ( OH ) D. No clinically relevant differences in safety were observed .\
CONCLUSIONS	This study confirms the efficacy and safety of fixed-dose combination of strontium ranelate 2 g/vitamin D 1000 IU for correction of vitamin D insufficiency in osteoporotic patients .\
\
###24274806\
OBJECTIVE	Coaction refers to the extent to which taking action on one behavior increases the odds of taking action on a second behavior .\
OBJECTIVE	This integrative study examines the generalization of coaction in three studies on weight-related behaviors .\
METHODS	Data from three randomized trials of tailored interventions ( n = 1,277 , n = 1,800 , and n = 6,000 ) were examined to determine if coaction of behavior change occurred differentially in treatment and control groups .\
METHODS	In each analysis , the likelihood of progressing to the Action or Maintenance stages for the target behaviors was evaluated using logistic regression .\
RESULTS	Despite differences in populations , targeted behaviors , levels of tailoring in interventions , and timing of follow-up assessments , 17 out of 24 ( 70.8 % ) logistic regressions revealed significant coaction in the treatment group as opposed to only three out of 24 ( 12.5 % ) in the control condition .\
RESULTS	In 23/24 analyses , coaction of behavior change was larger on an absolute basis in the treatment group .\
RESULTS	Individuals in the treatment group progressing to Action/Maintenance for one behavior were 1.4-5 times more likely to make progress on another behavior compared to those in the treatment group who did not make such progress on the first behavior .\
CONCLUSIONS	This study demonstrates that despite considerable variability in study design , coaction reliably occurs more in the presence of Transtheoretical-Model based multiple behavior change interventions .\
CONCLUSIONS	Additional studies are needed to replicate these results in other behavioral areas and to examine the predictors of differential coaction .\
CONCLUSIONS	The ability to consistently create coaction within multiple behavior interventions can increase the efficacy and cost-effectiveness of multiple behavior change interventions .\
\
###18400583\
OBJECTIVE	To compare the outcomes of single versus double intrauterine insemination .\
METHODS	This prospective randomized study was carried out in 100 infertile patients .\
METHODS	One intrauterine insemination was applied 36 hours after human chorionic gonadotropin ( hCG ) injection to 50 patients in the first group .\
METHODS	To 50 patients in the second group , two intrauterine inseminations were applied , of which the first was applied 24 hours after and the second 48 hours after the hCG injection .\
RESULTS	In the first group , pregnancies were detected in eight patients ( pregnancy rate per patient was 16 % , pregnancy rate per cycle was 10.6 % ) .\
RESULTS	In the second group , pregnancies were detected in five patients ( pregnancy rate per patient was 10 % , pregnancy rate per cycle was 6.4 % ) .\
RESULTS	There was no statistically significant difference between the two groups ( p > 0.05 ) .\
CONCLUSIONS	Single intrauterine insemination can be considered to be more reasonable than double intrauterine insemination treatment , taking into consideration the economic cost and the psychologic trauma to the patients .\
CONCLUSIONS	However , further studies with larger sample sizes are needed in order to reveal any actual differences between the two methods .\
\
###11909785\
OBJECTIVE	To determine the effect of the angiotensin converting enzyme inhibitor ramipril on the secondary prevention of stroke .\
METHODS	Randomised controlled trial with 2x2 factorial design .\
METHODS	267 hospitals in 19 countries .\
METHODS	9297 patients with vascular disease or diabetes plus an additional risk factor , followed for 4.5 years as part of the HOPE study .\
METHODS	Stroke ( confirmed by computed tomography or magnetic resonance imaging when available ) , transient ischaemic attack , and cognitive function .\
METHODS	Blood pressure was recorded at entry to the study , after 2 years , and at the end of the study .\
RESULTS	Reduction in blood pressure was modest ( 3.8 mm Hg systolic and 2.8 mm Hg diastolic ) .\
RESULTS	The relative risk of any stroke was reduced by 32 % ( 156 v 226 ) in the ramipril group compared with the placebo group , and the relative risk of fatal stroke was reduced by 61 % ( 17 v 44 ) .\
RESULTS	Benefits were consistent across baseline blood pressures , drugs used , and subgroups defined by the presence or absence of previous stroke , coronary artery disease , peripheral arterial disease , diabetes , or hypertension .\
RESULTS	Significantly fewer patients on ramipril had cognitive or functional impairment .\
CONCLUSIONS	Ramipril reduces the incidence of stroke in patients at high risk , despite a modest reduction in blood pressure .\
\
###18532970\
OBJECTIVE	To assess whether immediate removal of an indwelling catheter after anterior colporrhaphy influences the rate of re-catheterisation and symptomatic urinary tract infections .\
METHODS	A prospective randomised study conducted on 90 women divided into two groups who underwent anterior repair .\
METHODS	The indwelling catheter was removed immediately ( early catheter removal ) , and at least 24 h after the operation in case and control groups , respectively .\
METHODS	The association between clinical variables and the duration of catheterisation and continuous data were analysed by chi ( 2 ) test and two-tailed t-test , respectively .\
METHODS	Excel and SPSS 15.0 software were used , and a P-value of 0.05 or less was considered to indicate statistically significant differences .\
RESULTS	Symptomatic urinary tract infection was significantly lower in early catheter-removal group ; also patients in this group reported significantly less pain and voiding disturbances .\
RESULTS	Only a few of women required re-catheterisation after failing to void and all were able to resume normal voiding , also had shorter ambulation time and hospital stay .\
CONCLUSIONS	Early removal of an indwelling catheter immediately after anterior colporrhaphy was not associated with adverse events and increased rate of re-catheterisation .\
CONCLUSIONS	In this group , symptomatic urinary tract infection was significantly lower .\
CONCLUSIONS	Moreover , early removal of indwelling catheters immediately after operation seemed to decrease the ambulation time and hospital stay .\
\
###10396008\
BACKGROUND	Patients with double depression ( major depression + dysthymia ) have a particularly chronic course of illness , yet few studies have investigated treatments for these patients .\
METHODS	26 inpatients with double depression were assigned to two types of treatment : ( 1 ) pharmacotherapy and ( 2 ) combined treatment ( pharmacotherapy + cognitive-behavioral psychotherapy ) .\
METHODS	Treatment began while the patients were in the hospital and continued for 20 weeks after discharge .\
METHODS	Comprehensive assessments were conducted at the end of treatment as well as at 6 - and 12-month follow-up assessments .\
RESULTS	The results indicated that double-depressed patients who received the combined treatment had significantly lower levels of depression and higher social functioning at the end of treatment .\
RESULTS	However , no significant differences between groups were found at the follow-up assessments .\
CONCLUSIONS	These results suggest that the addition of cognitive-behavioral psychotherapy may produce an improved short-term outcome for patients with double depression .\
\
###15352602\
OBJECTIVE	Cranial nerve injuries , particularly motor nerve injuries , following carotid endarterectomy ( CEA ) can be disabling and therefore patients should be given reliable information about the risks of sustaining such injuries .\
OBJECTIVE	The reported frequency of cranial nerve injury in the published literature ranges from 3 to 23 % , and there have been few series in which patients were routinely examined before and after surgery by a neurologist .\
METHODS	The authors investigated the risk of cranial nerve injuries in patients who underwent CEA in the European Carotid Surgery Trial ( ECST ) , the largest series of patients undergoing CEA in which neurological assessment was performed before and after surgery .\
METHODS	Cranial nerve injury was assessed and recorded in every patient and persisting deficits were identified on follow-up examination at 4 months and 1 year after randomization .\
METHODS	Risk factors for cranial nerve injury were examined by performing univariate and multivariate analyses .\
METHODS	There were 88 motor cranial nerve injuries among the 1739 patients undergoing CEA ( 5.1 % of patients ; 95 % confidence interval [ CI ] 4.1-6 .2 ) .\
METHODS	In 23 patients , the deficit had resolved by hospital discharge , leaving 3.7 % of patients ( 95 % CI 2.9-4 .7 ) with a residual cranial nerve injury : 27 hypoglossal , 17 marginal mandibular , 17 recurrent laryngeal , one accessory nerve , and three Homer syndrome .\
METHODS	In only nine patients ( 0.5 % ; 95 % CI 0.24-0 .98 ) the deficit was still present at the 4-month follow-up examination ; however , none of the persisting deficits resolved during the subsequent follow up .\
METHODS	Only duration of operation longer than 2 hours was independently associated with an increased risk of cranial nerve injury ( hazard ratio 1.56 , p < 0.0001 ) .\
CONCLUSIONS	The risk of motor cranial nerve injury persisting beyond hospital discharge after CEA is approximately 4 % .\
CONCLUSIONS	The vast majority of neurological deficits resolve over the next few months , however , and permanent deficits are rare .\
CONCLUSIONS	Nevertheless , the risk of cranial nerve injury should be communicated to patients before they undergo surgery .\
\
###7921394\
BACKGROUND	Endometriosis is often encountered during laparoscopy performed for gamete intrafallopian transfer ( GIFT ) procedures .\
METHODS	A prospective randomized study involving 44 patients with endometriosis ( American Fertility Society ( AFS ) stages I through IV ) was conducted .\
METHODS	All patients underwent controlled ovarian hyperstimulation followed by laparoscopic GIFT procedures .\
METHODS	Twenty-one patients had no carbon dioxide laser vaporization of endometriosis and twenty-one patients did receive laser vaporization .\
METHODS	Two patients could not have GIFT performed due to tubal and peritubal disease .\
RESULTS	The results showed a clinical pregnancy rate of 38.1 percent in the treatment groups versus 47.9 percent in the control group ( not significant , Chi square , and Student 's test ) .\
RESULTS	The live birth rate from both groups was identical , at 23.8 percent per group .\
CONCLUSIONS	We conclude that CO2 laser vaporization of AFS stages I to IV endometriosis at the time of the GIFT procedure does not significantly affect either the clinical pregnancy rate or live birth rate from this form of assisted reproductive technology .\
\
###23719070\
BACKGROUND	Ultimately , the experience of pain derives from changes in brain excitability .\
BACKGROUND	Therefore , modulating the excitability of cortical areas involved in pain processing may become an attractive option in the context of multimodal analgesia during the postoperative period .\
BACKGROUND	Repetitive transcranial magnetic stimulation ( rTMS ) can reduce morphine consumption during the postoperative period after gastric bypass surgery .\
BACKGROUND	We tested the potential of another method of noninvasive brain stimulation , transcranial direct current stimulation ( tDCS ) , to reduce morphine consumption or pain perception during the postoperative period .\
METHODS	Fifty-nine ASA I to II patients undergoing lumbar spine surgery were randomized to receive anodal ( n = 20 ) , cathodal ( n = 20 ) , or sham ( n = 19 ) tDCS in the recovery room in a double-blind manner .\
METHODS	Morphine consumption administrated through patient-controlled analgesia ( PCA ) was the primary outcome ; pain perception as measured by visual analog scale was the secondary outcome .\
RESULTS	There were no statistically significant differences between the 3 groups of patients , either for PCA morphine consumption or for pain scores .\
CONCLUSIONS	Several factors may explain the observed lack of impact of tDCS on PCA morphine consumption and pain perception : the method of brain stimulation ( tDCS/rTMS ) , potential interactions with anesthetic drugs , differences in patients population ( gastric bypass surgery/lumbar spine surgery ) , and the previous experience of pain and chronic consumption of analgesic drugs .\
CONCLUSIONS	Further studies with tDCS should be performed before concluding that tDCS is inefficient for postoperative pain control , because noninvasive brain stimulation methods , such as rTMS and tDCS , may become attractive in the setting of multimodal analgesia .\
\
###16443425\
OBJECTIVE	Chronic fatigue syndrome is a clinical entity consisting of prolonged and debilitating fatigue in which concentration disturbances are very frequent .\
OBJECTIVE	Until now , no medical treatment has shown any efficacy .\
OBJECTIVE	The objectives of this study were to investigate the short-term effects of methylphenidate , an amphetamine derivative , on fatigue , concentration disturbances , and quality of life .\
METHODS	A double-blind randomized placebo-controlled crossover study was conducted in 60 patients who fulfilled the 1994 Centers for Disease Control criteria for chronic fatigue syndrome and had concentration difficulties .\
METHODS	Patients were enrolled between March 2003 and March 2004 at the outpatient department of a university hospital referral center for chronic fatigue syndrome patients .\
METHODS	Random assignment to 4 weeks treatment with methylphenidate 2 x 10 mg/day , followed by 4 weeks of placebo treatment , or 4 weeks of placebo treatment , followed by methylphenidate treatment .\
METHODS	Fatigue and concentration were measured with a Checklist Individual Strength ( CIS ) and a Visual Analogue Scale ( VAS ) .\
RESULTS	Fatigue scores fell significantly during methylphenidate intake in comparison with baseline ( mean difference : -0.7 , P = .010 for VAS ; mean difference : -11.8 , P < .0001 for CIS ) and in comparison with placebo ( mean difference : -1.0 , P = .001 for VAS ; mean difference : -9.7 , P < .0001 for CIS ) .\
RESULTS	Concentration disturbances , measured with a VAS improved significantly under methylphenidate treatment compared with baseline ( mean difference : -1.3 , P < .0001 ) and compared with placebo ( mean difference : -1.1 , P < .0001 ) .\
RESULTS	A clinical significant effect ( > or = 33 % improvement or CIS < or = 76 ) on fatigue was achieved in 17 % of patients , who were considered responders ; on concentration in 22 % of patients .\
CONCLUSIONS	Methylphenidate at a dose of 2 x 10 mg/day is significantly better than placebo in relieving fatigue and concentration disturbances in a minority of chronic fatigue syndrome patients .\
CONCLUSIONS	Further studies are needed to investigate the long-term effects of this treatment .\
\
###10192568\
OBJECTIVE	To define the correct time to remove the drain after axillary dissection for carcinoma of the breast .\
METHODS	Prospective randomised trial .\
METHODS	Two public hospitals , Israel .\
METHODS	90 women who required axillary dissection for carcinoma of the breast .\
METHODS	42 were randomised to have the drain removed on postoperative day 3 , and 48 to keep the drain in until discharge had decreased to less than 35 ml/24 hours .\
METHODS	Formation of seromas or wound infections , need to reinsert the drain , and duration of hospital stay .\
RESULTS	Early removal of the axillary drain was associated with a significantly higher incidence of seromas ( 9/42 compared with 2/48 , p = 0.02 ) unless the total amount of fluid drained during the first three postoperative days was less than 250 ml .\
CONCLUSIONS	Drains should be removed after axillary dissection only when the daily amount of fluid discharged is low , unless the drainage during the first three days is less than 250 ml .\
\
###19080399\
OBJECTIVE	To observe the clinical efficacy and therapeutic duration of oral corticosteroids in patients with acute exacerbations of chronic obstructive pulmonary diseases ( AECOPD ) .\
METHODS	A randomized , double-blinded , placebo-controlled clinical study was designed .\
METHODS	One hundred and thirty hospitalized patients with AECOPD were randomly divided into three groups : group 1 ( n = 44 ) received 30 mg/d of prednisone for 7 days and then placebo for another 7 days ; group 2 ( n = 43 ) received 30 mg/d of prednisone for 10 days , then tapered to 15 mg/d for 4 days ; group 3 ( n = 43 ) received placebo for 14 days .\
METHODS	The lung functions , arterial blood gas , length of stay , symptom scores , failure rate of treatment , side-effect of corticosteroids and the rate of relapse were evaluated before and after treatments .\
METHODS	The results were analyzed by statistical package for social science ( SPSS version 11.0 ) .\
METHODS	Measurement data were expressed by (-x) + / - s , and t test was used for the comparison of the data before and after treatments .\
METHODS	Chi-square test was used for the comparison of count data .\
METHODS	Analysis of variance was applied to test for differences between the three groups .\
METHODS	Multiple comparison was analyzed by SNK test .\
METHODS	Fisher exact test was used for the comparison of the failure rate of treatment , the rate of relapse and safety evaluation .\
RESULTS	Compared with the placebo group [ group 3 , ( 0.74 + / - 0.32 ) L ] , the FEV ( 1 ) in [ group 1 ( 0.87 + / - 0.23 ) L and in group 2 ( 0.93 + / - 0.30 ) L ] were significantly increased ( F = 4.53 , P < 0.05 ) .\
RESULTS	The PaO ( 2 ) in group 1 ( 79 + / - 9 ) mm Hg ( 1 mm Hg = 0.133 kPa ) and in group 2 ( 80 + / - 10 ) mm Hg were also increased significantly [ group 3 was ( 73 + / - 12 ) mm Hg ] ( F = 3.98 , P < 0.05 ) .\
RESULTS	The length of stay ( LOS ) in group 1 ( 12.5 + / - 3.5 ) d and in group 2 ( 12.4 + / - 4.1 ) d were shortened [ group 3 was ( 13.5 + / - 3.6 ) d ] ( F = 3.82 , P < 0.05 ) .\
RESULTS	However , no difference of FEV ( 1 ) , PaO ( 2 ) and LOS was found between 7-day and 14-day durations of corticosteroids therapy .\
RESULTS	There were no differences in symptom scores , failure rate of treatment , side-effect of corticosteroids and the rate of relapse among the 3 groups .\
CONCLUSIONS	Oral prednisone results in improvement of FEV ( 1 ) , PaO ( 2 ) and LOS in hospitalized patients with AECOPD .\
CONCLUSIONS	A 7-day or 14-day duration of oral prednisone is of the same clinical efficacy .\
CONCLUSIONS	From these results , we recommend that 30 mg/d of prednisone for a 7-day duration is appropriate for the treatment of AECOPD .\
\
###8349376\
BACKGROUND	Beta blockers and calcium antagonists are widely used in the management of angina pectoris in the belief that the combination is more efficacious than either drug alone .\
METHODS	This double blind randomised crossover placebo controlled study compares the effects of nicardipine , atenolol and their combination in 30 patients with chronic stable angina .\
METHODS	Each treatment period lasted 6 weeks with dose titration after 3 weeks .\
METHODS	Symptom limited treadmill exercise testing and radionuclide ventriculography at rest was carried out at the end of each treatment period .\
RESULTS	Total exercise duration and time to 1-mm ST-segment depression was significantly prolonged by nicardipine and atenolol when compared to placebo , the combination offered no additional benefit .\
RESULTS	Time to onset of angina was significantly prolonged by nicardipine and the combination but not by atenolol .\
RESULTS	Indices of left ventricular function were not significantly affected by any treatment other than an increase in left ventricular end diastolic volume on atenolol and the combination .\
CONCLUSIONS	Nicardipine and atenolol are equally effective in prolonging exercise duration and time to onset of ischemia in patients with chronic stable angina while the combination appeared to offer no additional benefit .\
CONCLUSIONS	Nicardipine prolonged the time to onset of angina significantly ; again there was no further improvement with the combination .\
CONCLUSIONS	Neither drug appears to have an important effect on the parameters of diastolic function studied in patients with chronic stable angina .\
\
###20971520\
OBJECTIVE	To evaluate the therapeutic benefits by adding chemotherapy ( + C ) and/or accelerated-fractionation ( AF ) for patients with T3-4N0-1M0 nasopharyngeal carcinoma .\
METHODS	From 1999 to 2004 , 189 eligible patients were randomized to one of four treatment groups ( CF/CF + C/AF/AF + C ) .\
METHODS	The number of fractions/week was 5 for the CF groups and 6 for the AF groups .\
METHODS	Patients in the + C groups were given concurrent cisplatin plus adjuvant cisplatin and fluorouracil .\
RESULTS	The AF+C group achieved significantly higher failure-free rate ( 88 % at 5-year ) than the CF group ( 63 % ; p = 0.013 ) , the AF group ( 56 % ; p = 0.001 ) and the CF+C group ( 65 % ; p = 0.027 ) .\
RESULTS	As compared with CF alone , the increase in late toxicity was statistically insignificant ( 36 % vs. 20 % ; p = 0.25 ) .\
RESULTS	Deaths due to cancer progression decreased ( 7 % vs. 33 % ; p = 0.011 ) but deaths due to incidental causes increased ( 9 % vs. 2 % ; p = 0.62 ) .\
RESULTS	Improvement in overall survival reached borderline significance ( 85 % vs. 66 % ; p = 0.058 ) .\
CONCLUSIONS	Concurrent-adjuvant chemotherapy combined with AF significantly reduced failure and cancer-specific deaths .\
CONCLUSIONS	Although the increase in major late toxicity and incidental deaths were statistically insignificant , a subtle increase in non-cancer deaths narrowed the overall survival gain .\
\
###11421892\
BACKGROUND	It has been suggested that pregnancy and early life may influence the development of asthma in the offspring , but published studies have not carefully controlled for potential biases .\
METHODS	In a large British birth cohort of 4065 natural children of 2583 mothers , we investigated whether in utero and perinatal influences contribute to the development and the severity of asthma in childhood , allowing for possible confounders of the relationship , and considering the nonindependence of familial data .\
RESULTS	Child asthma ( 10.1 % ) was more frequently reported by mothers when there had been health complications during pregnancy ( prevalence = 14.3 % ; adjusted odds ratio [ ORadj ] = 2.01 ; 95 % confidence interval , 1.52-2 .67 ) , labor , or delivery ( 19.3 % , ORadj = 1.35 , 1.01-1 .81 ) ; child illness or health complications during the first week of life ( 22.6 % , ORadj = 1.35 , 1.01-1 .82 ) ; and birth weight of < 2.5 kg ( 7.0 % , ORadj = 1.57 , 1.10-2 .25 ) .\
RESULTS	Specific causes of health complications during pregnancy which significantly related to asthma were early or threatened labor ( ICD : 644 ) ( 4.8 % , ORadj = 1.58 , 1.03-2 .40 ) and the malposition or malpresentation of the fetus ( ICD : 652 ) ( 1.6 % , ORadj = 3.63 , 1.47-8 .91 ) .\
CONCLUSIONS	The results provide further evidence that in utero and perinatal factors may increase the risk of developing asthma .\
\
###21296010\
BACKGROUND	Central morbidity and mortality conferences ensure uniform content and more participants but consume work hours in commuting for programs with multiple teaching hospitals .\
BACKGROUND	Internet-based televideoconferencing ( TVC ) technology has the potential to eliminate commuting and expand participation and retain quality of instruction .\
METHODS	A prospective , randomized pilot study compared a control ( home , n = 43 ) group in a live morbidity and mortality conference with an experimental ( remote , n = 35 ) group exposed to TVC .\
METHODS	After the conference , 78 participants ( 11 faculty , 38 residents , and 29 medical students ) completed a survey assessing learning ( 6 questions ) and conference effectiveness and appeal ( 7 questions ) .\
RESULTS	Comparison of pooled scores on the 6 test items showed no difference by home versus remote group ( 4.9 versus 4.4 ; p = 0.47 ) or among faculty , residents , and students ( 4.5 versus 4.7 versus 4.7 ; p = 0.89 ) , indicating that learning was not compromised by TVC .\
RESULTS	Overall perceptions of TVC were similar for home and remote sites ( 25.5 versus 23.4 ; p = 0.13 ) ; TVC was perceived as slightly less effective as attending a conference in person , but preferable to commuting .\
RESULTS	Perceptions of TVC grew proportionately more favorable as commuting distances increased .\
RESULTS	Students had a more positive perception of TVC than did residents , and faculty had the least positive perception ( p = 0.048 ) .\
RESULTS	Participants were comfortable giving a presentation via TVC , but less comfortable asking questions or participating in a discussion .\
CONCLUSIONS	This is the first study using televideoconferencing for morbidity and mortality .\
CONCLUSIONS	TVC did not hinder overall learning and was preferable to commuting between facilities .\
CONCLUSIONS	TVC can help maximize educational efficiency and opportunities in programs with multiple training sites .\
\
###11821459\
OBJECTIVE	To measure the psychosocial attitudes and beliefs of physicians working within oncology in the United Kingdom and to examine whether beliefs alter after communication skills training .\
OBJECTIVE	Additionally , to investigate whether physicians ' attitudes are reflected in communication behaviors with patients during interviews .\
METHODS	Ninety-three physicians completed a 32-item Physician Psychosocial Belief ( PPSB ) questionnaire at baseline ( T1 ) before randomization to attendance at a 3-day residential communication skills course ( n = 48 ) or a control group ( n = 45 ) .\
METHODS	Three months later ( T2 ) , both groups completed another PPSB and a self-assessment questionnaire recording perceived changes in communication with patients .\
METHODS	At both time points , physicians ' consultations with two consenting patients were videotaped .\
METHODS	Communication behaviors were measured using the Medical Interaction Processing System .\
RESULTS	Physicians who attended the course showed significantly improved attitudes and beliefs toward psychosocial issues compared with controls ( P = .002 ) .\
RESULTS	This improvement was reflected in the analysis of the videotaped recordings of their communication behaviors with patients .\
RESULTS	Expressions of empathy were more likely for the course group at T2 than the controls ( P = .02 ) , as were open questions ( P = .001 ) , appropriate responses to patient cues ( P = .005 ) , and psychosocial probing ( P = .041 ) .\
RESULTS	These objective findings were supported by physicians ' self report of changes in communication style during interviews with patients .\
CONCLUSIONS	Our results show that a communication skills training intervention using behavioral , cognitive , and affective components not only increases potentially beneficial and more effective interviewing styles but can also alter attitudes and beliefs , thus increasing the likelihood that such skills will be used in the clinical setting .\
\
###12834498\
OBJECTIVE	In a manikin study we recently assessed how effectively student operators were able to learn scaling with curettes ( GRA ) and power-driven instruments ( PP ) .\
OBJECTIVE	Calculating the debrided root area effectiveness was low in both groups without systematic training or without a motivational program .\
OBJECTIVE	After 10 weeks ( 20 h ) of training , operators reached a high effectiveness of 84.7 % ( GRA ) and 81.6 % ( PP ) .\
OBJECTIVE	The purpose of the present study was to evaluate the clinical outcome of nonsurgical treatment as performed by these student operators .\
METHODS	In a clinical trial , 19 students trained in the use of Gracey curettes for 10 weeks ( = 20 h ) ( GRA10 ) and Periopolisher system for 1 week ( = 2 h ) ( PP1 ) , and 20 students trained in the use of Gracey curettes for 1 week ( GRA1 ) and the Periopolisher for 10 weeks ( PP10 ) treated one patient each in a split-mouth design .\
METHODS	At baseline and 6 months , we recorded probing depth ( PD ) , probing attachment level ( PAL ) and bleeding on probing ( BOP ) by computer-assisted probing .\
METHODS	Statistical analysis was carried out for moderate ( category B ) and deep sites ( category C ) .\
METHODS	Groups were compared using Student 's t-tests ( p < 0.05 ) .\
RESULTS	Category B sites showed a PD reduction of 1.2 / 1.0 mm ( GRA10/GRA1 ) and 1.1 mm ( PP10/PP1 ) .\
RESULTS	PAL gain was 0.5 / 0.3 mm ( GRA10/GRA1 ) and 0.4 / 0.2 mm ( PP10/PP1 ) .\
RESULTS	In category C sites , PD reduction was 2.1 / 2.3 mm ( GRA10/GRA1 ) and 2.0 mm ( PP10/PP1 ) with a PAL gain of 0.6 / 0.9 mm ( GRA10/GRA1 ) and 0.4 mm ( PP10/PP1 ) .\
RESULTS	BOP was significantly lower in all groups .\
CONCLUSIONS	The results show that student operators who had received a systematical training on manikins and had attained different effectiveness results were able to treat periodontally diseased patients successfully using both Gracey and Periopolisher instruments .\
\
###18565093\
OBJECTIVE	The purpose of this study is to assess corneal staining and subjective symptom ratings with six different silicone hydrogel contact lens/multipurpose solution combinations , including the recently launched Menicon PremiO silicone hydrogel contact lens , after the first night of soaking the lenses in solution .\
METHODS	This study is a prospective , single-centre , subject-masked , contralateral , crossover , daily wear clinical trial in which subjects were randomly fitted in the morning with a different lens/solution combination in each eye , asked to wear the lenses for the whole day ( at least 12 h ) , soak each of the lenses overnight in one of the test solutions and insert the lenses on the following morning .\
METHODS	Subjects were asked to come on that morning for assessment of corneal staining and subjective ratings .\
METHODS	All subjects repeated this procedure on another two occasions in order to collect the results of the six different lens/solution combinations : Menicon PremiO/MeniCare Soft ; Menicon PremiO/Complete 10 ; Menicon PremiO/OptiFree Express ; Acuvue Oasys/MeniCare Soft ; Acuvue Oasys/Complete 10 ; Acuvue Oasys/OptiFree Express .\
RESULTS	Menicon PremiO lenses were associated with a lower level of corneal staining overall , and in the nasal and temporal locations , compared with Acuvue Oasys lenses ( p < 0.05 ) .\
RESULTS	No significant differences were found in corneal staining between solutions ( p > 0.05 ) .\
RESULTS	An overall rate of solution-induced corneal staining per eye of 12 % was found .\
RESULTS	Symptoms were very similar among the six different lens/solution combinations ( p > 0.05 ) .\
CONCLUSIONS	The lower level of corneal staining found with Menicon PremiO lenses compared with Acuvue Oasys lenses might be attributed to material , surface and design differences between lens types .\
CONCLUSIONS	The overall rate of solution-induced corneal staining and symptomatology found between the different lens/solutions combinations is consistent with previous studies .\
\
###22901564\
OBJECTIVE	Awaiting results from laboratory testing may sometimes be a rate-limiting step in emergency department ( ED ) throughput prolonging length of stay and contributing to crowding .\
OBJECTIVE	We determine whether introduction of a comprehensive metabolic panel point-of-care test can reduce ED length of stay compared with traditional central laboratory testing .\
METHODS	We performed a randomized , controlled trial among 10,244 noncritically ill ED patients aged 15 years and older whose physicians ordered a comprehensive metabolic panel at a single , large , academic , urban medical center .\
METHODS	Participants were randomly assigned to performance of a comprehensive metabolic panel by a point-of-care test ( n = 5,154 ) or central laboratory testing ( n = 5,090 ) .\
METHODS	The primary outcome was length of stay in the ED .\
RESULTS	A point-of-care test reduced median ED length of stay among all study patients by 22 minutes ( median 350 minutes [ interquartile range 206 to 1,002 minutes ] with point-of-care test versus median 372 minutes [ interquartile range 217 to 1,150 minutes ] with central laboratory testing ; median difference 22 minutes ; 95 % confidence interval [ CI ] 4 to 40 minutes ) .\
RESULTS	A point-of-care test also reduced ED length of stay in patients discharged to home ( 256 versus 268 minutes ; median difference 12 minutes ; 95 % CI 2 to 22 minutes ) and with an Emergency Severity Index triage level of 3 ( 333 versus 355 minutes ; median difference 22 minutes ; 95 % CI 4 to 40 minutes ) .\
CONCLUSIONS	Use of a point-of-care test for a comprehensive metabolic panel reduced ED length of stay compared with central laboratory testing in the adult ED of a single academic center .\
\
###14614003\
OBJECTIVE	This study compared the clinical toxicity and hematological effects of i.p. and s.c. administration of fms-like tyrosine kinase-3-ligand ( Flt3-L ; Amgen , Thousand Oaks , CA ) , a truncated glycoprotein that increases dendritic cells ( DCs ) and monocytes .\
METHODS	Patients with peritoneal carcinomatosis or mesothelioma were randomly assigned to treatment with Flt3-L ( 25 micro g/kg , maximum 1500 micro g ) , i.p. or s.c. , days 1-5 and 8-12 , then changed to the alternative route at 4 weeks .\
METHODS	Treatment was continued s.c. or i.p. at 8 weeks .\
RESULTS	Fifteen patients ( 14 evaluable ) were randomized to receive i.p. ( n = 8 ) or s.c. ( n = 7 ) injections .\
RESULTS	Their median age was 55 years ( range , 40-68 years ) .\
RESULTS	Primary tumors were as follows : ovarian/peritoneal cancer ( n = 9 ) ; gastrointestinal cancer ( n = 2 ) ; and mesothelioma ( n = 4 ) .\
RESULTS	Treatment was well tolerated without serious toxicity ( 24 i.p. cycles ; 32 s.c. cycles ) .\
RESULTS	Treatment ( i.p. or s.c. ) resulted in significant increases in WBCs ( WBC , monocytes , and Lin ( - ) DR ( + ) DCs ) , and platelets ( during washout ) .\
RESULTS	Both interleukin ( IL ) -12 ( p70 ) and IL-10 were secreted by monocyte-derived DCs after in vitro exposure to maturation factors .\
RESULTS	Increased IL-12 versus IL-10 secretion responses and higher proportions of the CD11c ( + ) DC subset in post-Flt3-L specimens suggested a maturational shift toward the monocyte-derived DC phenotype had occurred .\
RESULTS	Three patients ( 2 with mesothelioma and 1 with gastrointestinal cancer ) had stable disease for 8 , 8 , and 12 + months , respectively .\
CONCLUSIONS	Flt3-L , administered either i.p. or s.c. , is well tolerated and produced similar increases in monocytes , DCs , and platelets .\
CONCLUSIONS	DCs from peripheral blood and peritoneal fluids showed cell surface phenotypic and cytokine maturational responses to activation stimuli .\
CONCLUSIONS	These findings suggested that Flt3-L , in combination with suitable activating agents , could be developed further in patients with epithelial ovarian cancer .\
\
###19828955\
OBJECTIVE	To investigate patient-reported health-related quality of life ( HRQoL ) in data collected from a multinational randomized double-blind controlled trial comparing oral mesalazine ( 4 g ) + topical mesalazine enema ( 1 g ) to oral mesalazine alone ( 4 g ) .\
METHODS	HRQoL was collected using the EQ-5D at baseline and weeks 2 , 4 and 8 .\
METHODS	The EQ-5D assesses mobility , self-care , usual activities , pain/discomfort and anxiety/depression .\
METHODS	Scores from each dimension were reported individually , and converted into a weighted health state which reflects an individual 's perception of their health condition .\
RESULTS	At week 4 , a significant HRQoL improvement was observed for patients on mesalazine enemas compared to placebo enemas , with EQ-5D scores of 0.906 and 0.838 , respectively ( p < 0.05 ) .\
RESULTS	Mesalazine enema was found to reduce the probability of impairment at week 4 for mobility ( p = 0.049 ) and anxiety/depression ( p = 0.048 ) , and was of borderline significance for pain/discomfort ( p = 0.053 ) ; there was also an increased probability of influencing HRQoL changes for mobility ( p < 0.005 ) , usual activities ( p < 0.005 ) , pain/discomfort ( p < 0.005 ) and anxiety/depression ( p < 0.005 ) , based on reported HRQoL problems at baseline .\
CONCLUSIONS	Including 1 g mesalazine enemas with 4 g oral mesalazine significantly improved HRQoL in patients with active ulcerative colitis .\
CONCLUSIONS	The improvement in QoL of patients with UC preceded clinical remission , and this underlines the importance of including QoL instruments in clinical studies .\
\
###11773907\
BACKGROUND	Many pediatric patients undergoing cardiac surgery involving cardiopulmonary bypass have a predictable fall in the cardiac index 6 to 18 hours after surgery , the so-called low cardiac output syndrome ( LCOS ) .\
BACKGROUND	Because patients who have LCOS require more monitoring and support and have a prolonged stay in the intensive care unit , the syndrome is associated with a costly morbidity .\
BACKGROUND	Milrinone , a phosphodiesterase III inhibitor , improves cardiac muscle contractile force and vascular muscle relaxation through positive inotropic and vasodilatory effects .\
BACKGROUND	The purpose of the Prophylactic Intravenous Use of Milrinone After Cardiac Operation in Pediatrics ( PRIMACORP ) study is to evaluate the safety and efficacy of the prophylactic use of milrinone in pediatric patients at high risk for development of LCOS after undergoing cardiac surgery .\
METHODS	Patients in the multicenter , randomized , double-blind , placebo-controlled , parallel treatment study will be randomized to 1 of 3 treatment arms : ( 1 ) low-dose milrinone ( 25 microg/kg intravenous bolus over 60 minutes followed by a 0.25 microg/kg/min infusion for 35 hours ) , ( 2 ) high-dose milrinone ( 75 microg/kg intravenous bolus over 60 minutes followed by a 0.75 microg/kg/min infusion for 35 hours ) , or ( 3 ) placebo .\
RESULTS	The primary end point for efficacy evaluation will be based on a composite variable consisting of death or development of LCOS requiring additional mechanical or pharmacologic support , up to 36 hours after randomization .\
RESULTS	A 2-sided test with a 0.025 type I error will be used for the primary end point analysis .\
RESULTS	The PRIMACORP study will enroll a total of 240 patients .\
RESULTS	Six additional secondary end points will be analyzed .\
CONCLUSIONS	The PRIMACORP study will address several questions regarding the safety and efficacy of prophylactic milrinone use in pediatric patients at high risk for development of LCOS after cardiac surgery .\
\
###18042222\
OBJECTIVE	To evaluate the effectiveness of mineral trioxide aggregate ( MTA ) when used as a pulp capping material in primary teeth .\
METHODS	Clinical follow-up was performed on 25 symmetrical pairs of primary molars with deep occlusal caries , in 25 patients between the ages of 5 and 8 years .\
METHODS	Pulps exposed during cavity preparation were treated by direct pulp capping with MTA or calcium hydroxide , based with resin-bonded zinc oxide eugenol cement and restored with amalgam .\
METHODS	Clinical and radiographic examinations were carried out at 1 , 3 , 6 , 9 , 12 , 18 and 24 months .\
RESULTS	Twenty-four-month clinical and radiographic follow-ups were carried out on 22 patients .\
RESULTS	One patient failed to return for evaluation after 1 month , one after 9 months and another after 12 months .\
RESULTS	During follow-up , none of the MTA and calcium hydroxide groups exhibited clinical or radiographic failure .\
CONCLUSIONS	Mineral trioxide aggregate was found to be as successful as calcium hydroxide when used for direct pulp capping in primary teeth .\
CONCLUSIONS	Further histological investigations are needed to support these findings .\
\
###24991933\
BACKGROUND	Sleep-disturbed breathing ( SDB ) is common in patients with precapillary pulmonary hypertension ( PH ) .\
BACKGROUND	Nocturnal oxygen therapy ( NOT ) and acetazolamide improve SDB in patients with PH , and NOT improves exercise capacity .\
BACKGROUND	We investigated the effect of NOT and acetazolamide on nocturnal cardiac conduction , repolarization , and arrhythmias in patients with PH and SDB .\
METHODS	In a randomized , placebo-controlled , double-blind , crossover trial , 23 patients with arterial ( n = 16 ) or chronic thromboembolic PH ( n = 7 ) and SDB defined as a mean nocturnal oxygen saturation < 90 % or dips ( > 3 % ) > 10/h with daytime Pao2 7.3 kPa were studied .\
METHODS	Participants received NOT ( 3 L/min ) , acetazolamide tablets ( 2 250 mg ) , and sham-NOT/placebo each during 1 week separated by a 1-week washout period .\
METHODS	Three-lead ECG was recorded during overnight polysomnography at the end of each treatment period .\
METHODS	Repolarization indices were averaged over three cardiac cycles at late evening and at early morning , and nocturnal arrhythmias were counted .\
RESULTS	NOT was associated with a lower overnight ( 68 10 beats/min vs 72 9 beats/min , P = .010 ) and early morning heart rate compared with placebo .\
RESULTS	At late evening , the heart rate-adjusted PQ time was increased under acetazolamide compared with placebo ( mean difference , 10 milliseconds ; 95 % CI , 0-20 milliseconds ; P = .042 ) .\
RESULTS	In the morning under NOT , the heart rate-adjusted QT ( QTc ) interval was decreased compared with placebo ( mean difference , -25 milliseconds ; 95 % CI , -45 to -6 milliseconds ; P = .007 ) , and the interval between the peak and the end of the T wave on the ECG was shorter compared with acetazolamide ( mean difference , -11 milliseconds ; 95 % CI , -21 to -1 milliseconds ; P = .028 ) .\
RESULTS	Arrhythmias were rare and similar with all treatments .\
CONCLUSIONS	In patients with PH with SDB , NOT reduces nocturnal heart rate and QTc in the morning , thus , favorably modifying prognostic markers .\
BACKGROUND	ClinicalTrials.gov ; No. : NTC-01427192 ; URL : www.clinicaltrials.gov .\
\
###10204976\
OBJECTIVE	This study evaluated the effectiveness of cardiac counseling and rehabilitation programs led by a nurse counselor , compared with normal care on outcomes for myocardial infarction ( MI ) patients and their partners .\
METHODS	A randomized controlled trial with follow-up to 1 year was conducted with 100 patients recruited within 72 hours of a first MI and their partners : a Control group received normal care ; an Inpatient group received cardiac rehabilitation from a nurse counselor while in hospital ; and an Extended group received the same cardiac rehabilitation as the Inpatient group , but with additional sessions continuing up to 6 weeks after discharge from hospital .\
METHODS	The scales for main outcome measures were 1 ) knowledge of heart disease and treatment ( correct , misconceptions , and uncertainty ) ; 2 ) mood ( Hospital Anxiety and Depression Scale ) ; 3 ) satisfaction ; 4 ) disability ( Functional Limitations Profile ) .\
RESULTS	Inpatient cardiac counseling and rehabilitation resulted in more knowledge , less anxiety , less depression , and greater satisfaction with care in both patients and partners and in less disability in patients , with effects enduring to 1 year .\
RESULTS	There was some evidence of additional benefit from the Extended program .\
RESULTS	Both nurse counselors achieved benefits on all outcome variables .\
CONCLUSIONS	This Inpatient cardiac counseling and rehabilitation program resulted in significant and enduring benefits of clinical value .\
CONCLUSIONS	It is likely that it would be acceptable to most post-MI patients , many of whom are not offered or are unable to accept outpatient cardiac rehabilitation .\
\
###12882847\
OBJECTIVE	We evaluated the renoprotective effects as reflected by short-term changes in albuminuria of dual blockade of the renin-angiotensin system ( RAS ) by adding an angiotensin II receptor blocker ( ARB ) to treatment with maximal recommended doses of an ACE inhibitor ( ACEI ) in patients with type 2 diabetes and nephropathy .\
METHODS	A total of 20 patients ( 17 men and 3 women ) with type 2 diabetes along with hypertension and nephropathy were enrolled in this double-blind , randomized , two-period , crossover trial of 8 weeks of treatment with the ARB candesartan 16 mg daily and placebo added in random order to existing treatment with lisinopril/enalapril 40 mg daily or captopril 150 mg daily .\
METHODS	At the end of each treatment period , we evaluated albuminuria in three 24-h urinary collections by turbidimetry , 24-h ambulatory blood pressure ( ABP ) using the Takeda-TM2420 , and glomerular filtration rate ( GFR ) by the ( 51 ) Cr-EDTA plasma-clearance technique .\
RESULTS	During monoblockade of the RAS by ACEI treatment , albuminuria was 706 ( 349-1 ,219 ) mg/24 h [ geometric mean ( IQR ) ] ; 24-h ABP was 138 + / - 3/72 + / - 2 mmHg ( mean + / - SE ) ; and GFR was 77 + / - 6 ml x min ( -1 ) x 1.73 m ( -2 ) ( mean + / - SE ) .\
RESULTS	During dual blockade of the RAS by addition of candesartan 16 mg daily , there was a mean ( 95 % CI ) reduction in albuminuria of 28 ( 17-38 ) compared with ACEI alone ( P < 0.001 ) .\
RESULTS	There was a modest reduction in systolic/diastolic 24-h ABP of 3/2 mmHg ( -2 to 8 systolic , -2 to 5 diastolic ; NS ) .\
RESULTS	Changes in albuminuria did not correlate to changes in ABP .\
RESULTS	Addition of candesartan 16 mg daily induced a small , insignificant decrease in GFR of 4 ( -1 to 9 ) ml x min ( -1 ) x 1.73 m ( -2 ) .\
CONCLUSIONS	Dual blockade of the RAS provides superior short-term renoprotection independent of systemic blood pressure changes in comparison with maximally recommended doses of ACEI in patients with type 2 diabetes as well as nephropathy .\
\
###11327675\
OBJECTIVE	The purpose of this study was to determine the impact of extended wear of high and low oxygen permeability ( Dk ) lenses on the development or resolution of limbal hyperemia and corneal neovascularization in a randomized prospective clinical trial .\
METHODS	Adapted daily-wear contact lens wearers were randomly assigned to one of two groups .\
METHODS	The low-Dk group ( N = 23 ) wore etafilcon A lenses ( Dk/t = 40 ) for up to 7 days and 6 nights , and the high-Dk group ( N = 39 ) wore lotrafilcon A lenses ( Dk/t = 175 ) for up to 30 days and nights .\
METHODS	Limbal hyperemia and neovascularization were assessed and graded during 9 months of extended wear .\
METHODS	A stratified analysis to determine how change in ocular redness depended on initial presentation was also conducted .\
RESULTS	On a 0 to 100 scale , extended wear of low-Dk lenses resulted in a 16-point increase in limbal hyperemia ( p < 0.0001 ) ; no significant change occurred with the high-Dk lenses .\
RESULTS	The difference was greatest for low-Dk participants who initially presented with lower levels of hyperemia ( N = 18 ) .\
RESULTS	There was a slight resolution of redness in participants who initially presented with higher levels of hyperemia ( N = 10 ) after wearing the high-Dk lenses .\
RESULTS	Neovascularization increased by an average of 0.5 on a scale of 0 to 4 in low-Dk lens wearers ( p < 0.0001 ) but remained unchanged in the high-Dk lens wearers .\
RESULTS	The increase was most marked for the low-Dk group with lower levels of neovascularization at baseline .\
CONCLUSIONS	Subjects who wore lenses with higher oxygen permeability for 9 months of extended wear exhibited a lower vascular response of the ocular surface compared with subjects who wore lenses of lower oxygen permeability for the same period .\
CONCLUSIONS	This result was found both for the surface limbal vessels and in the deeper neovascular stromal vessels .\
CONCLUSIONS	Moderate neovascularization also developed after 3 months of extended wear of low-Dk hydrogels , whereas high-Dk lenses caused no neovascularization .\
\
###7477143\
BACKGROUND	Postmenopausal osteoporosis is a serious health problem , and additional treatments are needed .\
METHODS	We studied the effects of oral alendronate , an aminobisphosphonate , on bone mineral density and the incidence of fractures and height loss in 994 women with postmenopausal osteoporosis .\
METHODS	The women were treated with placebo or alendronate ( 5 or 10 mg daily for three years , or 20 mg for two years followed by 5 mg for one year ) ; all the women received 500 mg of calcium daily .\
METHODS	Bone mineral density was measured by dual-energy x-ray absorptiometry .\
METHODS	The occurrence of new vertebral fractures and the progression of vertebral deformities were determined by an analysis of digitized radiographs , and loss of height was determined by sequential height measurements .\
RESULTS	The women receiving alendronate had significant , progressive increases in bone mineral density at all skeletal sites , whereas those receiving placebo had decreases in bone mineral density .\
RESULTS	At three years , the mean ( + / - SE ) differences in bone mineral density between the women receiving 10 mg of alendronate daily and those receiving placebo were 8.8 + / - 0.4 percent in the spine , 5.9 + / - 0.5 percent in the femoral neck , 7.8 + / - 0.6 percent in the trochanter , and 2.5 + / - 0.3 percent in the total body ( P < 0.001 for all comparisons ) .\
RESULTS	The 5-mg dose was less effective than the 10-mg dose , and the regimen of 20 mg followed by 5 mg was similar in efficacy to the 10-mg dose .\
RESULTS	Overall , treatment with alendronate was associated with a 48 percent reduction in the proportion of women with new vertebral fractures ( 3.2 percent , vs. 6.2 percent in the placebo group ; P = 0.03 ) , a decreased progression of vertebral deformities ( 33 percent , vs. 41 percent in the placebo group ; P = 0.028 ) , and a reduced loss of height ( P = 0.005 ) and was well tolerated .\
CONCLUSIONS	Daily treatment with alendronate progressively increases the bone mass in the spine , hip , and total body and reduces the incidence of vertebral fractures , the progression of vertebral deformities , and height loss in postmenopausal women with osteoporosis .\
\
###12140400\
OBJECTIVE	To study the relationship between optic disc hemorrhages and four different groups of medications used in general vascular disease and diabetes .\
METHODS	The authors screened citizens of the city of Malm , Sweden who were between 57 and 79 years old ( 32,918 subjects ) , in order to find individuals with undetected glaucoma .\
METHODS	One set of optic disc photographs was taken of each participant and examined for optic disc hemorrhages .\
METHODS	Logistic regression was used , with platelet aggregation inhibitors , antihypertensive agents , cholesterol-lowering medication , and antidiabetic agents as independent variables that were tested in isolation as well as in various combinations and adjusted for age and gender .\
RESULTS	Optic disc hemorrhages were significantly more common in individuals taking platelet aggregation inhibitors ( OR 3.16 , P < 0.0001 ) .\
RESULTS	There was no significant association between ODH and the other three groups of medications .\
CONCLUSIONS	The significant relationship between platelet aggregation inhibitors and optic disc hemorrhages is a new and interesting finding that could indicate an association between optic disc hemorrhages and generalized vascular disease .\
CONCLUSIONS	Alternatively , it could mean that platelet aggregation inhibitors prolong resorption of or predispose to optic disc hemorrhages .\
\
###16014595\
BACKGROUND	Hospice care may improve the quality of end-of-life care for nursing home residents , but hospice is underutilized by this population , at least in part because physicians are not aware of their patients ' preferences .\
OBJECTIVE	To determine whether it is possible to increase hospice utilization and improve the quality of end-of-life care by identifying residents whose goals and preferences are consistent with hospice care .\
METHODS	Randomized controlled trial ( December 2003-December 2004 ) of nursing home residents and their surrogate decision makers ( N = 205 ) in 3 US nursing homes .\
METHODS	A structured interview identified residents whose goals for care , treatment preferences , and palliative care needs made them appropriate for hospice care .\
METHODS	These residents ' physicians were notified and asked to authorize a hospice informational visit .\
METHODS	The primary outcome measures were ( 1 ) hospice enrollment within 30 days of the intervention and ( 2 ) families ' ratings of the quality of care for residents who died during the 6-month follow-up period .\
RESULTS	Of the 205 residents in the study sample , 107 were randomly assigned to receive the intervention , and 98 received usual care .\
RESULTS	Intervention residents were more likely than usual care residents to enroll in hospice within 30 days ( 21/107 [ 20 % ] vs 1/98 [ 1 % ] ; P < .001 [ Fisher exact test ] ) and to enroll in hospice during the follow-up period ( 27/207 [ 25 % ] vs 6/98 [ 6 % ] ; P < .001 ) .\
RESULTS	Intervention residents had fewer acute care admissions ( mean : 0.28 vs 0.49 ; P = .04 [ Wilcoxon rank sum test ] ) and spent fewer days in an acute care setting ( mean : 1.2 vs 3.0 ; P = .03 [ Wilcoxon rank sum test ] ) .\
RESULTS	Families of intervention residents rated the resident 's care more highly than did families of usual care residents ( mean on a scale of 1-5 : 4.1 vs 2.5 ; P = .04 [ Wilcoxon rank sum test ] ) .\
CONCLUSIONS	A simple communication intervention can increase rates of hospice referrals and families ' ratings of end-of-life care and may also decrease utilization of acute care resources .\
\
###19955891\
BACKGROUND	Scalp infiltration with epinephrine-lidocaine solution in patients undergoing neurosurgery may result in transient but significant hypotension .\
BACKGROUND	We investigated whether premedication with alpha2-adrenoreceptor agonist clonidine , which also exhibits alpha1-adrenoreceptor mediated vasoconstriction , would prevent or attenuate this fall in mean arterial pressure ( MAP ) .\
METHODS	Sixty-six American Society of Anesthesiologists I and II adult patients , 18 to 50 years , undergoing elective tumor decompression were recruited into this prospective , randomized , double-blind , placebo controlled study , and scheduled to receive either oral pantoprazole 40 mg ( placebo group ) or oral clonidine 3 microg/kg ( clonidine group ) , 90 minutes before induction of anesthesia .\
METHODS	Primary end points studied were heart rate ( HR ) and MAP in both groups measured just before scalp infiltration ( preinfiltration baseline ) and then every 30 seconds for 5 minutes after initiation of scalp infiltration with 2.5 microg/mL epinephrine contained in 15 mL of 1 % lidocaine solution .\
RESULTS	There was no significant change in HR in the 2 groups during the study period compared with baseline values ; however , patients in clonidine group had significantly lower HR compared with placebo ( * P < 0.05 ) .\
RESULTS	In both groups , MAP fell significantly below baseline 1 minute after start of infiltration .\
RESULTS	It recovered in the clonidine group after 2.5 minutes but not in the placebo group where it continued to remain low even at 5 minutes .\
RESULTS	MAP in the placebo group was also significantly lower compared with the clonidine group from 2.5 minutes to 5 minutes .\
CONCLUSIONS	In conclusion , oral clonidine 3 microg/kg administered 90 minutes before induction of anesthesia attenuates the fall in MAP due to scalp infiltration with a dilute concentration of epinephrine-lidocaine solution in patients undergoing craniotomy under isoflurane anesthesia .\
\
###19636365\
BACKGROUND	Current therapies for cutaneous leishmaniasis are limited by poor efficacy , long-term course of treatment , and the development of resistance .\
BACKGROUND	We evaluated if pentavalent antimony ( an anti-parasitic drug ) combined with imiquimod ( an immunomodulator ) was more effective than pentavalent antimony alone in patients who had not previously been treated .\
METHODS	A randomized double-blind clinical trial involving 80 cutaneous leishmaniasis patients was conducted in Peru .\
METHODS	The study subjects were recruited in Lima and Cusco ( 20 experimental and 20 control subjects at each site ) .\
METHODS	Experimental arm : Standard dose of pentavalent antimony plus 5 % imiquimod cream applied to each lesion three times per week for 20 days .\
METHODS	Control arm : Standard dose of pentavalent antimony plus placebo ( vehicle cream ) applied as above .\
METHODS	The primary outcome was cure defined as complete re-epithelization with no inflammation assessed during the 12 months post-treatment period .\
RESULTS	Of the 80 subjects enrolled , 75 completed the study .\
RESULTS	The overall cure rate at the 12-month follow-up for the intention-to-treat analysis was 75 % ( 30/40 ) in the experimental arm and 58 % ( 23/40 ) in the control arm ( p = 0.098 ) .\
RESULTS	Subgroup analyses suggested that combination treatment benefits were most often observed at the Cusco site , where L. braziliensis is the prevalent species .\
RESULTS	Over the study period , only one adverse event ( rash ) was recorded , in the experimental arm .\
CONCLUSIONS	The combination treatment of imiquimod plus pentavalent antimony performed better than placebo plus pentavalent antimony , but the difference was not statistically significant .\
BACKGROUND	Clinical Trials.gov NCT00257530 .\
\
###18230858\
OBJECTIVE	A randomized controlled trial was conducted to compare the language and auditory processing outcomes of children assigned to receive the Fast ForWord Language intervention ( FFW-L ) with the outcomes of children assigned to nonspecific or specific language intervention comparison treatments that did not contain modified speech .\
METHODS	Two hundred sixteen children between the ages of 6 and 9 years with language impairments were randomly assigned to 1 of 4 conditions : ( a ) Fast ForWord Language ( FFW-L ) , ( b ) academic enrichment ( AE ) , ( c ) computer-assisted language intervention ( CALI ) , or ( d ) individualized language intervention ( ILI ) provided by a speech-language pathologist .\
METHODS	All children received 1 hr and 40 min of treatment , 5 days per week , for 6 weeks .\
METHODS	Language and auditory processing measures were administered to the children by blinded examiners before treatment , immediately after treatment , 3 months after treatment , and 6 months after treatment .\
RESULTS	The children in all 4 conditions improved significantly on a global language test and a test of backward masking .\
RESULTS	Children with poor backward masking scores who were randomized to the FFW-L condition did not present greater improvement on the language measures than children with poor backward masking scores who were randomized to the other 3 conditions .\
RESULTS	Effect sizes , analyses of standard error of measurement , and normalization percentages supported the clinical significance of the improvements on the Comprehensive Assessment of Spoken Language ( E. Carrow-Woolfolk , 1999 ) .\
RESULTS	There was a treatment effect for the Blending Words subtest of the Comprehensive Test of Phonological Processing ( R. K. Wagner , J. K. Torgesen , & C. A. Rashotte , 1999 ) .\
RESULTS	Participants in the FFW-L and CALI conditions earned higher phonological awareness scores than children in the ILI and AE conditions at the 6-month follow-up testing .\
CONCLUSIONS	Fast ForWord Language , the intervention that provided modified speech to address a hypothesized underlying auditory processing deficit , was not more effective at improving general language skills or temporal processing skills than a nonspecific comparison treatment ( AE ) or specific language intervention comparison treatments ( CALI and ILI ) that did not contain modified speech stimuli .\
CONCLUSIONS	These findings call into question the temporal processing hypothesis of language impairment and the hypothesized benefits of using acoustically modified speech to improve language skills .\
CONCLUSIONS	The finding that children in the 3 treatment conditions and the active comparison condition made clinically relevant gains on measures of language and temporal auditory processing informs our understanding of the variety of intervention activities that can facilitate development .\
\
###20843375\
BACKGROUND	The main hypothesis of this study is that neutral pH , low glucose degradation product ( GDP ) peritoneal dialysis ( PD ) fluid better preserves residual renal function in PD patients over time compared with conventional dialysate .\
METHODS	Inclusion criteria are adult PD patients ( CAPD or APD ) aged 18-81 years whose first dialysis was within 90 days prior to or following enrolment and who have a residual GFR 5 ml/min/1 .73 m2 , a urine output 400 ml/day and an ability to understand the nature and requirements of this trial .\
METHODS	Pregnant or lactating patients or individuals with an active infection at the time of enrolment , a contra-indication to PD or participation in any other clinical trial where an intervention is designed to moderate rate of change of residual renal function are excluded .\
METHODS	Patients will be randomized 1:1 to receive either neutral pH , low GDP dialysis solution ( Balance ) or conventional dialysis solution ( Stay.safe ) for a period of 2 years .\
METHODS	During this 2 year study period , urinary urea and clearance measurements will be performed at 0 , 3 , 6 , 9 , 12 , 18 and 24 months .\
METHODS	The primary outcome measure will be the slope of residual renal function decline , adjusted for centre and presence of diabetic nephropathy .\
METHODS	Secondary outcome measures will include time from initiation of peritoneal dialysis to anuria , peritoneal small solute clearance , peritoneal transport status , peritoneal ultrafiltration , technique survival , patient survival , peritonitis rates and adverse events .\
METHODS	A total of 185 patients has been recruited into the trial .\
CONCLUSIONS	This investigator-initiated study has been designed to provide evidence to help nephrologists determine the optimal dialysis solution for preserving residual renal function in PD patients .\
BACKGROUND	Australian New Zealand Clinical Trials Registry Number : ACTRN12606000044527 .\
\
###7807658\
OBJECTIVE	To assess pairwise differences between placebo , unopposed estrogen , and each of three estrogen/progestin regimens on selected heart disease risk factors in healthy postmenopausal women .\
METHODS	A 3-year , multicenter , randomized , double-blind , placebo-controlled trial .\
METHODS	A total of 875 healthy postmenopausal women aged 45 to 64 years who had no known contraindication to hormone therapy .\
METHODS	Participants were randomly assigned in equal numbers to the following groups : ( 1 ) placebo ; ( 2 ) conjugated equine estrogen ( CEE ) , 0.625 mg/d ; ( 3 ) CEE , 0.625 mg/d plus cyclic medroxyprogesterone acetate ( MPA ) , 10 mg/d for 12 d/mo ; ( 4 ) CEE , 0.625 mg/d plus consecutive MPA , 2.5 mg/d ; or ( 5 ) CEE , 0.625 mg/d plus cyclic micronized progesterone ( MP ) , 200 mg/d for 12 d/mo .\
METHODS	PRIMARY ENDPOINTS : Four endpoints were chosen to represent four biological systems related to the risk of cardiovascular disease : ( 1 ) high-density lipoprotein cholesterol ( HDL-C ) , ( 2 ) systolic blood pressure , ( 3 ) serum insulin , and ( 4 ) fibrinogen .\
METHODS	Analyses presented are by intention to treat .\
METHODS	P values for primary endpoints are adjusted for multiple comparisons ; 95 % confidence intervals around estimated effects were calculated without this adjustment .\
RESULTS	Mean changes in HDL-C segregated treatment regimens into three statistically distinct groups : ( 1 ) placebo ( decrease of 0.03 mmol/L [ 1.2 mg/dL ] ) ; ( 2 ) MPA regimens ( increases of 0.03 to 0.04 mmol/L [ 1.2 to 1.6 mg/dL ] ) ; and ( 3 ) CEE with cyclic MP ( increase of 0.11 mmol/L [ 4.1 mg/dL ] ) and CEE alone ( increase of 0.14 mmol/L [ 5.6 mg/dL ] ) .\
RESULTS	Active treatments decreased mean low-density lipoprotein cholesterol ( 0.37 to 0.46 mmol/L [ 14.5 to 17.7 mg/dL ] ) and increased mean triglyceride ( 0.13 to 0.15 mmol/L [ 11.4 to 13.7 mg/dL ] ) compared with placebo .\
RESULTS	Placebo was associated with a significantly greater increase in mean fibrinogen than any active treatment ( 0.10 g/L compared with -0.02 to 0.06 g/L ) ; differences among active treatments were not significant .\
RESULTS	Systolic blood pressure increased and postchallenge insulin levels decreased during the trial , but neither varied significantly by treatment assignment .\
RESULTS	Compared with other active treatments , unopposed estrogen was associated with a significantly increased risk of adenomatous or atypical hyperplasia ( 34 % vs 1 % ) and of hysterectomy ( 6 % vs 1 % ) .\
RESULTS	No other adverse effect differed by treatment assignment or hysterectomy status .\
CONCLUSIONS	Estrogen alone or in combination with a progestin improves lipoproteins and lowers fibrinogen levels without detectable effects on postchallenge insulin or blood pressure .\
CONCLUSIONS	Unopposed estrogen is the optimal regimen for elevation of HDL-C , but the high rate of endometrial hyperplasia restricts use to women without a uterus .\
CONCLUSIONS	In women with a uterus , CEE with cyclic MP has the most favorable effect on HDL-C and no excess risk of endometrial hyperplasia .\
\
###21383323\
OBJECTIVE	The globus pallidus internus ( GPi ) has been the primary target for deep brain stimulation ( DBS ) to treat severe medication-refractory dystonia .\
OBJECTIVE	Some patients with primary cervical or segmental dystonia develop subtle bradykinesia occurring in previously nondystonic body regions during GPi DBS .\
OBJECTIVE	Subthalamic nucleus ( STN ) DBS may provide an alternative target choice for treating dystonia , but has only been described in a few short reports , without blinded rating scales , statistical analysis , or detailed neuropsychological studies .\
METHODS	In this prospective pilot study , we analyzed the effect of bilateral STN DBS on safety , efficacy , quality of life , and neuropsychological functioning in 9 patients with medically refractory primary cervical dystonia .\
METHODS	Severity of dystonia was scored by a blinded rater ( unaware of the patient 's preoperative or postoperative status ) using the Toronto Western Spasmodic Torticollis Rating Scale ( TWSTRS ) preoperatively and 3 , 6 , and 12 months postsurgery .\
METHODS	Lead location , medications , and adverse events were also measured .\
RESULTS	STN DBS was well-tolerated with no serious adverse effects .\
RESULTS	The TWSTRS total score improved ( p < 0.001 ) from a mean ( SEM ) of 53.1 ( 2.57 ) , to 19.6 ( 5.48 ) at 12 months .\
RESULTS	Quality of life measures were also improved .\
RESULTS	STN DBS induced no consistent neuropsychological deficits .\
RESULTS	Several patients reported depression in the study and 3 had marked weight gain .\
RESULTS	No patients developed bradykinetic side effects from stimulation , but all patients developed transient dyskinetic movements during stimulation .\
CONCLUSIONS	This prospective study showed that bilateral STN DBS resulted in improvement in dystonia and suggests that STN DBS may be an alternative to GPi DBS for treating primary cervical dystonia .\
METHODS	This study provides Class III evidence that bilateral subthalamic nucleus deep brain stimulation results in significant improvement in cervical dystonia without bradykinetic side effects .\
\
###21855223\
BACKGROUND	Current literature suggests that acute nicotine administration provides a compensatory mechanism by which alcoholics might alleviate attentional deficits .\
BACKGROUND	In contrast , chronic smoking is increasingly recognized as negatively affecting neurobehavioral integrity .\
BACKGROUND	These opposing effects have not been simultaneously examined .\
BACKGROUND	Thus , we sought to a ) extend previous work by exploring the effects of acute nicotine effects on vigilance components of attention and replicate previous findings suggesting that treatment-seeking alcoholics experience benefit to a greater extent than do other groups ; and b ) to examine the impact of chronic smoking on these tasks and across subgroups .\
METHODS	Substance abusing participants ( N = 86 ) were recruited and subgrouped on the basis of dependency criteria as either alcoholics , alcoholics with co-morbid stimulant dependence , or stimulant dependent individuals .\
METHODS	Groups of cigarette-smoking ( N = 17 ) and non-smoking ( N = 22 ) community controls were recruited as comparison groups .\
METHODS	Smoking subjects were assigned a placebo , low , or high dose nicotine patch in a double-blind placebo controlled fashion .\
METHODS	Non-smoking controls were administered either a placebo or low dose .\
METHODS	Testing occurred after dose stabilization .\
RESULTS	General linear models indicated greater sensitivity to acute nicotine administration among alcoholics than other groups when controlling for the effect of intensity of smoking history , as reflected by pack-years .\
RESULTS	Pack-years correlated negatively with performance measures in alcoholics but not stimulant abusing subgroups or smoking controls .\
RESULTS	Finally , regression analyses demonstrated that pack-years predicted poorer performance only for the alcoholic subgroup .\
CONCLUSIONS	These results support previous work finding a compensatory effect of acute nicotine administration on attentional performance in alcoholics and reinforce the consideration of recent nicotine use as a confound in neurocognitive studies of alcoholics .\
CONCLUSIONS	Of particular interest is the finding that smoking history as reflected in pack-years predicted poorer performance , but only among alcoholics .\
CONCLUSIONS	Further systematic study of these opposing effects among alcoholics and other groups using a broader array of tasks is needed .\
\
###21834113\
BACKGROUND	Warfarin is implicated in approximately 30 % of reported anticoagulant-related errors .\
BACKGROUND	In order to improve anticoagulation management and safety , our institution implemented an inpatient Pharmacist-Directed Anticoagulation Service ( PDAS ) .\
OBJECTIVE	To evaluate the impact of this service on both transition of care and safety of patients receiving warfarin anticoagulation .\
METHODS	Cluster randomized trial .\
METHODS	Large , urban teaching hospital and level 1 trauma center .\
METHODS	All patients receiving warfarin on two medical and two cardiology units .\
METHODS	A PDAS provided dosing , monitoring , and coordination of transition from the inpatient-to-outpatient setting .\
METHODS	Endpoints were assessed during hospitalization and 30 days after discharge .\
METHODS	Transition of care was considered effective if compliance with all of the transition of care metrics occurred .\
METHODS	The transition of care metrics included : appropriate enrollment in the anticoagulation clinic , documented inpatient-to-outpatient provider contact , documented inpatient provider-to-anticoagulation clinic communication and patient follow-up with the anticoagulation clinic within five days of discharge .\
METHODS	Safety was measured by the composite endpoint of thromboembolism , major bleeding , or international normalized ratio ( INR ) 5 .\
RESULTS	This study included 500 patients .\
RESULTS	Transition of care metric compliance occurred in 73 % more patients in the PDAS group ( P < 0.001 ) .\
RESULTS	There was also a 32 % reduction in the composite safety endpoint in the PDAS group ( P = 0.103 ) .\
RESULTS	This finding was driven by a reduction in rate of INR 5 ( P = 0.076 ) .\
CONCLUSIONS	Implementation of a PDAS provides a net improvement in quality of care for the patient taking warfarin in the inpatient setting .\
\
###21874629\
BACKGROUND	VISULAS 532 s VITE is a 532 nm laser device which allows semi-automated photocoagulation in fast cascades with short pulse durations in addition to conventional retinal single-spot coagulation .\
METHODS	In a prospective randomised study 101 peripheral laser treatments for retinopathy of various origins were divided into two groups : control group A ( n = 35 ) coagulation in conventional single-spot modus and study group B ( n = 66 ) coagulation with the new semiautomated VITE-function of VISULAS 532 s. Spot diameter was the same in both groups ( 300 m at the retina ) .\
METHODS	Patients were asked about pain immediately after therapy on a scale ranging from 0 ( = no pain ) up to 10 ( = maximum pain ) .\
METHODS	From video recording , treatment times were measured .\
METHODS	After each treatment , a photo-documentation followed to control the laser effects .\
METHODS	The shorter laser pulses in group B were offset by higher laser power to achieve similar moderate effects .\
RESULTS	In group A 509 ( 462-609 ) effects were set with a pulse duration of 100-150 ms and power of 157 ( 70-380 ) mW .\
RESULTS	46.0 % of the patients complained of pain at an intensity of 4.4 ( 2-8 ) .\
RESULTS	The treatment time was 73.4 ( 61.6 to 103.7 ) s per 100 effects .\
RESULTS	In group B 555 ( 120-600 ) effects were set with pulse duration of 20 ms and a power of 286 ( 120-600 ) mW .\
RESULTS	1.3 % of the patients complained of pain at an intensity of 3 and 4 .\
RESULTS	The treatment time was 49.4 ( 24.0-97 .5 ) s per 100 effects .\
RESULTS	None of the groups experienced complications .\
CONCLUSIONS	The semiautomated function of the laser using a 20 ms pulse duration allows almost painless coagulation of the retina .\
CONCLUSIONS	The treatment times can be reduced by one third .\
CONCLUSIONS	This leads to improved patient compliance .\
CONCLUSIONS	Long-term results regarding the regression of proliferative changes are still lacking .\
\
###22424833\
OBJECTIVE	To evaluate the efficacy of intraocular injections with bevacizumab in patients with macular edema ( ME ) secondary to central retinal vein occlusion ( CRVO ) .\
METHODS	Prospective , randomized , sham injection-controlled , double-masked clinical trial .\
METHODS	Sixty patients with ME secondary to CRVO .\
METHODS	At baseline , patients were randomized 1:1 to receive intraocular injections of bevacizumab or sham injections every 6 weeks for 6 months .\
METHODS	The primary outcome measure was the proportion of patients gaining at least 15 letters at 6 months .\
METHODS	Secondary outcome measures included mean change from baseline best-corrected visual acuity ( BCVA ) , foveal thickness , and neovascular glaucoma .\
RESULTS	At the end of follow-up , 18 of 30 patients ( 60.0 % ) in the study group had gained 15 letters compared with 6 of 30 patients ( 20.0 % ) in the control group ( P = 0.003 ) .\
RESULTS	The BCVA improved by 14.1 letters at 24 weeks compared with a decrease of 2.0 letters in the control group ( P < 0.003 ) .\
RESULTS	The mean decrease in central retinal thickness ( CRT ) was significantly greater in the study group ( 426 m ) than in the control group ( 102 m ) at all time points up to week 24 ( P < 0.001 ) .\
RESULTS	No residual edema , defined as CRT < 300 m at 24 weeks , was found in 26 of 30 patients ( 86.7 % ) in the treatment group compared with 6 of 30 patients ( 20 % ) in the control group ( P < 0.001 ) .\
RESULTS	In the sham group , 5 of 30 patients ( 16.7 % ) had developed iris rubeosis at week 24 .\
RESULTS	No patients in the study group had rubeosis at week 24 ( P = 0.052 ) .\
RESULTS	There were no events of endophthalmitis , retinal tear , or retinal detachment during the 24-week treatment period .\
RESULTS	No serious non-ocular adverse events were reported .\
CONCLUSIONS	Intraocular injections of bevacizumab given every 6 weeks for 6 months improve visual acuity ( VA ) and reduce ME significantly compared with sham .\
BACKGROUND	Proprietary or commercial disclosure may be found after the references .\
\
###22358277\
BACKGROUND	Retrograde autologous priming ( RAP ) is a cardiopulmonary bypass ( CPB ) method , at low cost .\
BACKGROUND	Previous studies have shown that this method reduces hemodilution and blood transfusions needs through increased intra-operative hematocrit .\
OBJECTIVE	To evaluate RAP method , in relation to standard CPB ( crystalloid priming ) , in adult patients .\
METHODS	Sixty-two patients were randomly allocated to two groups : 1 ) Group RAP ( n = 27 ) of patients operated using the RAP and ; 2 ) Control group of patients operated using CPB standard crystalloid method ( n = 35 ) .\
METHODS	The RAP was performed by draining crystalloid prime from the arterial and venous lines , before CPB , into a collect recycling bag .\
METHODS	The main parameters analyzed were : 1 ) CPB hemodynamic data ; 2 ) Hematocrit and hemoglobin values ; 3 ) The need for blood transfusions .\
RESULTS	It was observed statistically significant fewer transfusions during surgery and reduced CPB hemodilution using RAP .\
RESULTS	The CPB hemodynamic values were similar , observing a tendency to use lower CPB flows in the RAP group patients .\
CONCLUSIONS	This investigation was designed to be a small-scale pilot study to evaluate the effects of RAP , which were demonstrated concerning the CPB hemodilution and blood transfusions .\
\
###22669453\
BACKGROUND	In colorectal cancer , the morphology of the invasive tumor margin may reflect aggressiveness of tumor growth , thus providing important prognostic information .\
BACKGROUND	The tumor growth pattern according to Jass and the extent of tumor budding were analyzed in patients with American Joint Committee on Cancer/Union for International Cancer Control ( AJCC/UICC ) stage II disease .\
METHODS	Tumors of 120 randomly selected patients with AJCC/UICC stage II disease were retrospectively reviewed for tumor growth pattern ( expanding vs. infiltrating ) and the extent of tumor budding , with high-grade budding reflecting presence of 10 or more budding foci scattered at the invasive tumor margin .\
METHODS	Progression-free and cancer-specific survivals were determined by the Kaplan-Meier method .\
METHODS	For multivariable analysis , Cox 's proportional hazards regression models were performed .\
RESULTS	The infiltrating growth pattern was significantly associated with histological subtype and lymphovascular invasion , while high-grade budding was significantly associated with tumor grade and lymphovascular invasion .\
RESULTS	High-grade budding , but not the infiltrating growth pattern , was significantly associated with outcome in univariable analysis .\
RESULTS	Cox 's proportional hazards regression models proved tumor budding to be an independent predictor of disease progression ( hazard ratio 3.91 , 95 % confidence interval 1.3-11 .77 ; P = 0.02 ) and cancer-related death ( hazard ratio 5.90 , 95 % confidence interval 1.62-21 .51 ; P = 0.007 ) .\
RESULTS	The combination of infiltrating growth pattern and high-grade budding did not have a stronger prognostic significance than tumor budding alone .\
CONCLUSIONS	Tumor budding independently predicted patient outcome in patients with AJCC/UICC stage II colorectal cancer and may therefore be used for accurate prognostication , patient counseling , and design of clinical trials by using integrated multimodal therapy .\
\
###19614639\
BACKGROUND	Changes in P-wave morphology have recently been shown to be associated with interatrial conduction route used , without noticeable changes of P-wave duration .\
BACKGROUND	This study aimed at exploring the association between P-wave morphology and future atrial fibrillation ( AF ) development in the Multicenter Automatic Defibrillator Trial II ( MADIT II ) population .\
METHODS	Patients included in MADIT-II without a history of AF with sinus rhythm at baseline who developed AF during the study ( `` Pre-AF '' ) were compared to matched controls without AF development ( `` No-AF '' ) .\
METHODS	Patients were followed for a mean of 20 months .\
METHODS	A 10-minute high-resolution bipolar ECG recording was obtained at baseline .\
METHODS	Signal-averaged P waves were analyzed to determine orthogonal P-wave morphology , P-wave duration , and RMS20 .\
METHODS	The P-wave morphology was subsequently classified into one of three predefined types using an automated algorithm .\
RESULTS	Thirty patients ( age 68 + / - 7 years ) who developed AF during MADIT-II were compared with 60 patients ( age 68 + / - 8 years ) who did not .\
RESULTS	P-wave duration and RMS20 in the Pre-AF group was not significantly different from the No-AF group ( 143 + / - 21 vs 139 + / - 30 ms , P = 0.26 , and 2.0 + / - 1.3 vs 2.1 + / - 1.0 muV , P = 0.90 ) .\
RESULTS	The distribution of P-wave morphologies was shifted away from Type 1 in the Pre-AF group when compared to the No-AF group ( Type 1/2/3 / atypical ; 25/60/0 / 15 % vs 10/63/10 / 17 % , P = 0.04 ) .\
CONCLUSIONS	This study is the first to describe changes in P-wave morphology in patients prior to AF development .\
CONCLUSIONS	The results indicate that abnormal interatrial conduction may play a role in AF development in patients with prior myocardial infarction and congestive heart failure .\
\
###11382723\
BACKGROUND	In view of the central role of the tissue factor-factor VIIa pathway in the initiation of blood coagulation , novel therapeutic strategies aimed at inhibiting this catalytic complex are currently being evaluated .\
BACKGROUND	A limitation of this new class of anticoagulants may be the lack of an appropriate strategy to reverse the effect if a bleeding event occurs .\
BACKGROUND	The aim of this study was to investigate the in vivo potential of recombinant factor VIIa ( rVIIa ) to induce thrombin generation in healthy subjects pretreated with recombinant nematode anticoagulant protein c2 , a specific inhibitor of the tissue factor-factor VIIa complex , in a double-blind randomized crossover study .\
RESULTS	Administration of nematode anticoagulant protein c2 ( 3.5 microgram/kg ) caused a prolongation of the prothrombin time from 13.7 + / -0.6 to 16.9 + / -1.2 seconds .\
RESULTS	The subsequent injection of rVIIa ( 90 microgram/kg ) resulted in an immediate and complete correction of the prothrombin time and a marked generation of thrombin , reflected by increased levels of prothrombin activation fragment F1 +2 and thrombin-antithrombin complexes from 0.75 + / -0.64 to 3.29 + / -6.3 nmol/L and from 2.4 + / -0.6 to 10.7 + / -3.9 microgram/mL , respectively .\
RESULTS	Factor X and IX activation peptides showed a 3.5-fold and a 3.8-fold increase , respectively , after the administration of rVIIa in the presence of nematode anticoagulant protein c2 .\
CONCLUSIONS	During treatment with an inhibitor of the tissue factor-factor VIIa complex , the infusion of rVIIa resulted in thrombin generation .\
CONCLUSIONS	Our results indicate that rVIIa may be a good candidate as an antidote for inhibitors of tissue factor .\
\
###24999076\
BACKGROUND	The management of perioperative period for patients with spontaneous intracerebral hemorrhage affects the prognosis .\
BACKGROUND	Elevated blood pressure is common in the patients with spontaneous intracerebral hemorrhage and related to a poor outcome .\
BACKGROUND	However , study on antihypertensive treatment for surgical patients with spontaneous intracerebral hemorrhage is insufficient .\
OBJECTIVE	To determine if the intensive antihypertensive treatment improves the prognosis compared with the conservative antihypertensive treatment followed guidelines in perioperative period for patients with spontaneous intracerebral hemorrhage .\
METHODS	PATICH is a prospective , parallel , randomized , assessor-blinded trial .\
METHODS	Two hundred eligible patients will be assigned to the intensive group and conservative group randomly .\
METHODS	Patients allocated to the intensive group will receive an intensive antihypertensive treatment aiming to achieve a target systolic blood pressure of between 120 mmHg and 140 mmHg while the patients in the conservative group will receive conservative antihypertensive treatment as recommended by guidelines for 7 days .\
METHODS	Operation will be conducted by well-trained surgeons and the best medical treatment will be given in all patients .\
METHODS	Patients will be followed up at 7 days , 30 days , and 90 days .\
RESULTS	Primary outcome of this study is the rate of rehemorrhage in 7 days after surgery .\
RESULTS	Secondary outcomes include death and dependency at 90 days incidence of ischemic stroke , separate rate of death and dependency at 90 days , health related quality of life ( HRQoL ) at 90 days , incidence of other vascular events , and days of hospitalization .\
RESULTS	Dependency is defined by a score of 3-5 based on the modified Rankin Scale ( mRS ) .\
\
###24044802\
OBJECTIVE	Partial breast irradiation ( PBI ) is an alternative to whole-breast irradiation after breast-conserving surgery in selected patients .\
OBJECTIVE	Until the results of randomized phase III studies are available , phase II studies inform about PBI .\
OBJECTIVE	We report the 5 year results of a phase II prospective study with PBI using interstitial multi-catheter high-dose-rate brachytherapy ( ClinicalTrials.gov Identifier : NCT00499057 ) .\
METHODS	Hundred patients received PBI ( 4 Gy , twice a day for 4 days , until 32 Gy ) .\
METHODS	Inclusion criteria were : age 40years , infiltrating carcinoma without lobular histology , ductal in situ carcinoma , tumor size 2.5 cm , negative surgical margins and axillary lymph nodes .\
RESULTS	At a median follow-up of 60 months late toxicity occurred in 25 patients ; the 5-year probability of freedom from late toxicity was 72.6 % ( 95 % CI : 63.7-81 .7 ) .\
RESULTS	Tamoxifen was the only significant risk factor for late toxicity .\
RESULTS	Cosmetic results , judged by physicians and patients , were good/excellent in 98 patients .\
RESULTS	Three local relapses ( 1 true , 2 elsewhere ) and 1 regional relapse occurred .\
RESULTS	The 5-year probability of local or regional relapse-free survival was 97.7 % ( 95 % CI : 91.1-99 .4 ) and 99.0 % ( 95 % CI : 92.9-99 .8 ) , respectively .\
CONCLUSIONS	PBI with interstitial multi-catheter brachytherapy is associated with low relapse and late toxicity rates .\
\
###23652892\
BACKGROUND	Tazarotene 0.1 % gel and cream are effective topical treatments for acne .\
BACKGROUND	Tazarotene foam , 0.1 % was developed to provide an alternative , safe , and effective formulation .\
OBJECTIVE	To evaluate efficacy and tolerability of tazarotene foam , 0.1 % in adults and adolescents with acne vulgaris .\
METHODS	Two randomized , double-blind , vehicle-controlled , parallel-group studies were conducted at 39 centers in the United States and Canada .\
METHODS	The first study involved 744 participants and the second 742 , aged 12 to 45 years , who were randomized to receive treatment with either tazarotene foam , 0.1 % or vehicle foam once daily for 12 weeks .\
METHODS	Lesion counts , Investigator 's Static Global Assessments ( ISGA ) , and Subject 's Global Assessments ( SGA ) were evaluated at baseline and weeks 2 , 4 , 8 , and 12 .\
METHODS	Tolerability was monitored throughout the study .\
RESULTS	At week 12 in both studies , treatment with tazarotene foam led to greater decreases from baseline in mean absolute and percentage change in lesion counts ( noninflammatory , inflammatory , and total ) , greater proportion of participants with 2-grade improvement in ISGA score , and greater proportion of participants with ISGA score of 0 or 1 than vehicle treatment ( P < .001 for all ) .\
RESULTS	Only application-site skin irritation and dryness were reported by > 5 % of participants in active treatment groups in both studies .\
CONCLUSIONS	The efficacy and tolerability of tazarotene foam were not compared directly with those of other formulations .\
CONCLUSIONS	Tazarotene foam , 0.1 % significantly reduced the number and severity of acne lesions after 12 weeks and had a safe and acceptable tolerability profile .\
\
###14769785\
OBJECTIVE	To evaluate the efficacy of adenoidectomy compared with long term chemoprophylaxis and placebo in the prevention of recurrent acute otitis media in children aged between 10 months and 2 years .\
METHODS	Randomised , double blind , controlled trial .\
METHODS	Oulu University Hospital , a tertiary centre in Finland .\
METHODS	180 children aged 10 months to 2 years with recurrent acute otitis media .\
METHODS	Adenoidectomy , sulfafurazole ( sulphisoxazole ) 50 mg/kg body weight , given once a day for six months or placebo .\
METHODS	Follow up lasted for two years , during which time all symptoms and episodes of acute otitis media were recorded .\
METHODS	Intervention failure ( two episodes in two months or three in six months or persistent effusion ) during follow up , number of episodes of acute otitis media , number of visits to a doctor because of any infection , and antibiotic prescriptions Number of prescriptions , and days with symptoms of respiratory infection .\
RESULTS	Compared with placebo , interventions failed during both the first six months and the rest of the follow up period of 24 months similarly in the adenoidectomy and chemoprophylaxis groups ( at six months the differences in risk were 10 % ( 95 % confidence interval -9 % to 29 % ) and 18 % ( -2 % to 38 % ) , respectively ) .\
RESULTS	No significant differences were observed between the groups in the numbers of episodes of acute otitis media , visits to a doctor , antibiotic prescriptions , and days with symptoms of respiratory infection .\
CONCLUSIONS	Adenoidectomy , as the first surgical treatment of children aged 10 to 24 months with recurrent acute otitis media , is not effective in preventing further episodes .\
CONCLUSIONS	It can not be recommended as the primary method of prophylaxis .\
\
###18161933\
OBJECTIVE	To prospectively evaluate the efficacy and safety of partial splenic embolization ( PSE ) combined with transcatheter hepatic arterial chemoembolization ( TACE ) in treatment of hepatocellular carcinoma ( HCC ) .\
METHODS	Fifty patients suffering from primary HCC associated with hypersplenism caused by cirrhosis were randomly assigned to 2 groups : group A receiving PSE combined with TACE ( n = 26 ) and group B receiving TACE alone ( n = 24 ) .\
METHODS	Follow-up examinations included calculation of peripheral blood cells ( leukcytes , platelets and red blood cells ) and treatment-associated complications .\
RESULTS	Prior to treatment , there was no significant difference in sex , age , Child-Pugh grade , tumor diameter , mass pathology type and peripheral blood cell counts between the 2 groups .\
RESULTS	After treatment , leukocyte and platelet counts were significantly higher in group A during the 3-mo follow-up period ( P < 0.05 ) , but lower in group B ( P < 0.05 ) .\
RESULTS	Severe complications occurred in 3 patients ( 11.5 % ) of group A and in 19 patients ( 79.2 % ) of group B ( P < 0.05 ) , and there was no significant difference in symptoms of post-embolization syndrome , including abdominal pain , fever , mild nausea and vomiting between the 2 groups ( P > 0.05 ) .\
CONCLUSIONS	PSE combined with TACE is more effective and safe than TACE alone for patients with HCC associated with hypersplenism caused by cirrhosis .\
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###9625213\
OBJECTIVE	We investigated whether patient-centered communication skills can be taught to residents in Internal Medicine by using a time-limited behaviorally oriented intervention .\
METHODS	Residents working at the Department of Internal Medicine were randomly assigned to an intervention group ( IG ; N = 19 ) or a control group ( CG ; N = 23 ) .\
METHODS	In addition to 6 hours of standard medical education per week , the IG received specific communication training of 22.5 hours duration within a 6-month period .\
METHODS	Initially and 10 months later , participants performed interviews with simulated patients .\
METHODS	Interviews were rated by blinded raters who used the Maastricht History and Advice Checklist-Revised .\
RESULTS	Compared with the CG , the IG improved substantially in many specific communication skills .\
RESULTS	Both groups improved in the `` amount of medical information identified '' and in the ability to `` communicate about feasibility of treatment . ''\
CONCLUSIONS	Patient-centered communication skills such as those presented in this intervention study can be taught .\
CONCLUSIONS	The ability to gain medical information and the readiness to communicate about aspects of medical treatment seem to improve with more professional experience ; however , they also profit from the intervention .\
\
###8605634\
OBJECTIVE	To describe the design of the HOPE ( Heart Outcomes Prevention Evaluation ) study .\
METHODS	Description of the key design features of HOPE , a large , simple randomized trial of two widely applicable treatments -- ramipril , an angiotensin-converting enzyme inhibitor ; and vitamin E , a naturally occurring antioxidant vitamin -- in the prevention of myocardial infarction , stroke or cardiovascular death .\
METHODS	Two-hundred and sixty-seven hospitals , physician offices and clinics in Canada , the United States , Mexico , Europe and South America .\
METHODS	Over 9000 women and men aged 55 years and above at high risk for cardiovascular events such as myocardial infarction and stroke were recruited over 18 months .\
METHODS	A 2X2 factorial design with ramipril and vitamin E with follow-up for up to four years .\
CONCLUSIONS	HOPE will be one of the largest trials of two new interventions to prevent myocardial infarction , stroke or cardiovascular death in high risk patients .\
CONCLUSIONS	The results of HOPE will have direct public health impact and are likely to be readily incorporated into clinical practice .\
CONCLUSIONS	Key design features of HOPE are inclusion of individuals at high risk of cardiovascular disease , inclusion of a substantial proportion of patients with diabetes ( 36 % ) and women ( 27 % ) , and detailed substudies to provide data on mechanisms of benefit .\
\
###21344051\
OBJECTIVE	A one-way nasal resistor has recently been shown to reduce sleep disordered breathing ( SDB ) in a subset of patients with Obstructive Sleep Apnea Hypopnea Syndrome ( OSAHS ) .\
OBJECTIVE	The purpose of this study was to examine characteristics predictive of therapeutic response to the device and provide pilot data as to its potential mechanisms of action .\
OBJECTIVE	PATIENTS , INTERVENTIONS , AND MEASUREMENTS : 20 subjects ( 15M/5F , age 54 12 years , BMI 33.5 5.6 kg/m ) with OSAHS underwent 3 nocturnal polysomnograms ( NPSG ) including diagnostic , therapeutic ( with a Provent nasal valve device ) , and CPAP .\
OBJECTIVE	Additional measurements included intranasal pressures and PCO , closing pressures ( Pcrit ) , and awake lung volumes in different body positions .\
RESULTS	In 19/20 patients who slept with the device , RDI was significantly reduced with the nasal valve device compared to the diagnostic NPSG ( 27 29/h vs 49 28/h ) , with 50 % of patients having an acceptable therapeutic response .\
RESULTS	Among demographic , lung volume , or diagnostic NPSG measures or markers of collapsibility , no significant predictors of therapeutic response were found .\
RESULTS	There was a suggestion that patients with position-dependent SDB ( supine RDI > lateral RDI ) were more likely to have an acceptable therapeutic response to the device .\
RESULTS	Successful elimination of SDB was associated with generation and maintenance of an elevated end expiratory pressure .\
RESULTS	No single definitive mechanism of action was elucidated .\
CONCLUSIONS	The present study shows that the nasal valve device can alter SDB across the full spectrum of SDB severity .\
CONCLUSIONS	There was a suggestion that subjects with positional or milder SDB in the lateral position were those most likely to respond .\
\
###20658563\
OBJECTIVE	To investigate whether inhaling 50 % xenon during hypothermia ( HT ) offers better neuroprotection than xenon or HT alone .\
METHODS	Ninety-eight newborn pigs underwent a 45-minute global hypoxic-ischemic insult severe enough to cause permanent brain injury , and 12 pigs underwent sham protocol .\
METHODS	Pigs then received intravenous anesthesia and were randomized to 6 treatment groups : ( 1 ) normothermia ( NT ; rectal temperature 38.5 degrees C , n = 18 ) ; ( 2 ) 18 hours 50 % xenon with NT ( n = 12 ) ; ( 3 ) 12 hours HT ( rectal temperature 33.5 degrees C , n = 18 ) ; ( 4 ) 24 hours HT ( rectal temperature 33.5 degrees C , n = 17 ) ; ( 5 ) 18 hours 50 % xenon with 12 hours HT ( n = 18 ) ; and ( 6 ) 18 hours 50 % xenon with 24 hours HT ( n = 17 ) .\
METHODS	Fifty percent xenon was administered via a closed circle with 30 % oxygen and 20 % nitrogen .\
METHODS	After 10 hours rewarming , cooled pigs remained normothermic until terminal perfusion fixation at 72 hours .\
METHODS	Global and regional brain neuropathology and clinical neurological scores were performed .\
RESULTS	Xenon ( p = 0.011 ) and 12 or 24 hours HT ( p = 0.003 ) treatments offered significant histological global , and regional neuroprotection .\
RESULTS	Combining xenon with HT yielded an additive neuroprotective effect , as there was no interaction effect ( p = 0.54 ) .\
RESULTS	Combining Xenon with 24 hours HT offered 75 % global histological neuroprotection with similarly improved regional neuroprotection : thalamus ( 100 % ) , brainstem ( 100 % ) , white matter ( 86 % ) , basal ganglia ( 76 % ) , cortical gray matter ( 74 % ) , cerebellum ( 73 % ) , and hippocampus ( 72 % ) .\
RESULTS	Neurology scores improved in the 24-hour HT and combined xenon HT groups at 72 hours .\
CONCLUSIONS	Combining xenon with HT is a promising therapy for severely encephalopathic infants , doubling the neuroprotection offered by HT alone .\
\
###25219129\
OBJECTIVE	To observe the effect of warm-reinforcing needling combined with modern rehabilitation training on motor function of cerebral palsy ( CP ) children .\
METHODS	Sixty cases of CP children were randomly divided into acupuncture combined with rehabilitation ( Acu + Rehab , n = 30 ) group and Rehab ( n = 30 ) group .\
METHODS	Patients of the Acu + Rehab group were treated by warm-reinforcing needling stimulation of Jiaji ( EX-B 2 ) , Jianyu ( LI 15 ) , Quchi ( LI 11 ) , Hegu ( LI 4 ) , Zusanli ( ST 36 ) , Yinlingquan ( GB 34 ) , Sanyinjiao ( SP 6 ) , Juegu ( GB 39 ) , Yanglingquan ( GB 34 ) , etc. , combined with Bobath rehabilitation therapy , and those of the Rehab group treated by Bobath rehabilitation ( stimulating key control points in the body , triggering reflexes that provide head and body control ) .\
METHODS	The treatment was conducted every day , with three months being a therapeutic course , two courses in all .\
METHODS	The Peabody Developmental Motor Scales 2 ( PDMS-2 ) was used to evaluate the CP children 's motor function [ 1 ) gross motor : posture ( straightness ratio ) , locomotion and object manipulation ; 2 ) fine motor : grasping and visual-Motor integration ] .\
RESULTS	After the treatment , of the 30 and 30 cases in the Acu + Rehab and Rehab groups , 1 ( 3.33 % ) and 0 ( 0 % ) were cured , 20 ( 66.67 % ) and 18 ( 60.00 % ) experienced marked improvement , 9 ( 30.00 % ) and 12 ( 40.00 % ) were invalid , with the effective rates being 70.00 % and 60.00 % respectively .\
RESULTS	The therapeutic effect of the Acu + Rehab group was markedly superior to that of the Rehab group ( P < 0.05 ) .\
RESULTS	After 6 months ' treatment , the scores of posture , locomotor , object manipulation and grasping , and visual-movement integration were significantly increased in comparison with pre-treatment in the same one group ( P < 0.05 ) , and the effects of the Acu + Rehab group were obviously superior to those of Rehab group in increasing the scores of posture , locomotor , object manipulation and grasping after 6 months ' treatment ( P < 0.05 ) .\
CONCLUSIONS	Warm-reinforcing needling combined with Bobath rehabilitation has a better therapeutic effect in improving gross motor and fine motor functions of CP children .\
\
###9119568\
BACKGROUND	This report identifies demographic and health-related baseline factors associated with non-compliance and attrition in elderly subjects participating in a preventive intervention study over a 4-year follow-up period .\
METHODS	The Cox proportional hazards model and polychotomous logistic regression were used to evaluate time to clinic assessment non-compliance and type of non-participation .\
RESULTS	Of 1785 subjects , 35.6 percent were non-compliant during follow-up which meant they were eligible to participate at the time they were contacted but would not or could not return for an assessment .\
RESULTS	Refusals due to a lack of continuing interest or being too busy , and those citing health problems constituted the major subgroups of non-compliers .\
RESULTS	Death , unable to contact , and ineligible due to disenrollment or moving away accounted for nearly 20 percent .\
RESULTS	Four-year compliance was achieved by 44.4 percent of the participants .\
RESULTS	Time to non-compliance was significantly shorter with older age , lower annual income , poorer personal health ranking , and , to a marginal extent , depression .\
RESULTS	Lower annual income was associated with all reasons for non-participation including disenrollment or moving .\
RESULTS	Other factors correlated with specific types of nonparticipation .\
CONCLUSIONS	These results can be useful in designing more effective cohort maintenance strategies .\
CONCLUSIONS	Greater resources may be allocated to subgroups who are less likely to continue .\
\
###21635363\
OBJECTIVE	To examine the long-term effects of earlier initiated continuous Kangaroo Mother Care ( KMC ) for relatively stable low-birth-weight ( LBW ) infants in a resource-limited country .\
METHODS	A randomized controlled trial with long-term follow-up was performed in LBW infants in Madagascar .\
METHODS	Earlier continuous KMC ( intervention group ) was initiated as soon as possible within 24 h postbirth , and later continuous KMC ( control group : conventional care ) was initiated after complete stabilization .\
METHODS	Outcome measures were mortality or readmission , nutritional indicators at 6-12 months postbirth and feeding condition at 6 months postbirth ( ClinicalTrials.gov , NCT00531492 ) .\
RESULTS	A total of 72 infants were followed for mortality or readmission at 6-12 months postbirth .\
RESULTS	There was no difference between the two groups ( 7/36 vs. 7/36 , Risk ratio ( RR ) , 1.00 ; 95 % CIs , 0.39-2 .56 ; p = 1.00 ) .\
RESULTS	The proportion of exclusive breast feeding ( EBF ) at 6 months postbirth was significantly higher with earlier KMC than later KMC ( 12/29 vs. 4/26 ; RR 2.69 ; 95 % CIs , 1.00-7 .31 ; p = 0.04 ) .\
RESULTS	There were no differences in nutritional indicators between the two groups at 6-12 months postbirth .\
CONCLUSIONS	Earlier initiated continuous KMC results in a significantly higher proportion of EBF at 6 months postbirth .\
CONCLUSIONS	Further larger-scale long-term evaluations of earlier initiated continuous KMC for LBW infants are needed .\
\
###23695976\
OBJECTIVE	Breath alcohol concentration ( BrAC ) estimation training has been effective in increasing estimation accuracy in social drinkers .\
OBJECTIVE	Predictors of estimation accuracy may identify populations to target for training , yet potential predictors typically are not evaluated .\
OBJECTIVE	In addition , the therapeutic efficacy of estimation training as a preventive strategy for problematic drinking is unknown .\
METHODS	Forty-six social drinkers with a recent binge history were randomly assigned to an intervention or control group ( n = 23 per group ) .\
METHODS	In each of three sessions ( pretraining , training , testing ) , participants consumed alcohol ( 0.32 , 0.24 , 0.16 and 0.08 g/kg , in random order ) every 30 min ( total dose : 0.8 g/kg ) .\
METHODS	Participants provided five BrAC estimates within 3 h of alcohol administration .\
METHODS	The intervention group , but not control group , received internal and external training .\
METHODS	During testing , participants provided BrAC estimates , but received no feedback .\
METHODS	Participants returned for two follow-up visits to complete self-report measures .\
RESULTS	BrAC estimation training improved intervention group estimation accuracy within the laboratory .\
RESULTS	Together , training , low trait anxiety and low risk expectancy predicted high testing accuracy .\
RESULTS	There were no significant group differences in subsequent alcohol consumption , behavior under the influence or risk expectancy regarding potentially hazardous behaviors .\
CONCLUSIONS	BrAC estimation training is effective in the laboratory but may not translate into naturalistic settings .\
\
###24687430\
OBJECTIVE	To investigate and compare several quantification methods of myocardial perfusion measurements , paying special attention to the relation between the techniques and the required measurement duration .\
METHODS	Seven patients underwent contrast-enhanced rest and stress cardiac perfusion measurements at 3T .\
METHODS	Three slices were acquired in each patient and were divided into 16 segments , leading to 112 rest and stress data curves , which were analyzed using various tracer kinetic models as well as a model-free deconvolution .\
METHODS	Plasma flow , plasma volume , and myocardial perfusion reserve were analyzed for the complete acquisition as well as for the first pass data only .\
RESULTS	Deconvolution analysis yielded stable results for both rest and stress analysis , while Fermi and one compartment models agree well for first pass data ( rest measurements only ) and prolonged data acquisition ( stress measurements only ) .\
RESULTS	More complex models do not yield satisfactory results for the short measurement times investigated in this study .\
CONCLUSIONS	When performing MRI-based quantification of myocardial perfusion , care must be taken that the method used is appropriate for the time frame under investigation .\
CONCLUSIONS	When a numerical deconvolution is used instead of tracer kinetic models , more stable results are obtained .\
\
###21485725\
OBJECTIVE	We performed a randomized clinical trial to estimate whether preoperative use of misoprostol may reduce intraoperative blood loss of patients treated by minimally invasive surgery ( MIS ) , such as laparoscopic ( LM ) or laparoscopically assisted myomectomy ( LAM ) .\
METHODS	Sixty-seven menstruating patients with three or less myomas of a maximum diameter of 90 mm , scheduled for MIS , were randomly allocated to receive a preoperative single dose of intravaginal misoprostol or placebo .\
METHODS	Sixty-four patients remained in the final analysis : 30 in the misoprostol ( I ) and 34 in the placebo group ( II ) .\
METHODS	Estimated blood loss ( EBL ) , decline of postoperative hemoglobin ( Hb ) and side-effects of administered agent were the outcomes of main interest .\
RESULTS	The EBL was significantly higher in the placebo versus misoprostol group ( 217 + / - 74 vs 126 + / - 41 , respectively ) .\
RESULTS	Similarly , the decline of postoperative Hb was significantly higher in group II ( 1.6 + / - 0.43 ) compared to group I ( 1 + / - 0.33 ) .\
RESULTS	The operative time was comparable in both groups , while the rate of side-effects was similar between groups .\
CONCLUSIONS	The preoperative use of misoprostol in patients with uterine fibroids managed by minimally invasive surgery significantly reduces intraoperative blood loss .\
CONCLUSIONS	Misoprostol might be useful for the prevention of postoperative anemia in more extended minimal invasive interventions , such as myomectomy of large fibroids or laparoscopic hysterectomy .\
\
###22669332\
OBJECTIVE	The antiestrogen , Raloxifene ( Ral ) is an effective breast cancer chemopreventive agent .\
OBJECTIVE	Omega-3 fatty acids ( n-3FA ) may inhibit mammary carcinogenesis .\
OBJECTIVE	On the basis of their mechanisms of action , we test the hypothesis that a combination of n-3FA and Ral may be superior in reducing select biomarkers of breast cancer risk in women .\
METHODS	Postmenopausal women at increased risk for breast cancer ( breast density 25 % ) were randomized to : ( 1 ) no intervention ; ( 2 ) Ral 60 mg ; ( 3 ) Ral 30 mg ; ( 4 ) n-3FA ( Lovaza ) 4 g and ( 5 ) Lovaza 4 g + Ral 30 mg for 2 years .\
METHODS	Reduction in breast density is the primary end point of the study .\
METHODS	We report preliminary data on feasibility , compliance and changes in secondary end points related to IGF-I signaling , estrogen metabolism , oxidative stress and inflammation in the first group of 46 women who completed 1 year of the study .\
RESULTS	All interventions were well tolerated with excellent compliance ( 96 1 % overall ) by pill count and also supported by the expected rise in both serum n-3FA and n-3FA / Omega-6 fatty acids ( n-6FA ) ratio in women randomized to groups 4 and 5 ( P < 0.05 ) .\
RESULTS	Lovaza decreased serum triglycerides and increased high-density lipoprotein ( HDL ) cholesterol compared with control ( P < 0.05 for both ) .\
RESULTS	Ral reduced serum IGF-1 in a dose-dependent manner ( P < 0.05 ) while Lovaza did not .\
RESULTS	Lovaza had no effect on IGF-1 or IGFBP-3 .\
RESULTS	None of the other biomarkers were affected by our treatment .\
CONCLUSIONS	The combination of Lovaza and Ral is a feasible strategy that may be recommended in future breast cancer chemoprevention trials .\
\
###17286243\
BACKGROUND	Sulfido-Leukotrienes are important inflammatory mediators of bronchial asthma , intolerance of acetylsalicylic acid ( ASA ) , polyposis nasi and allergic rhinitis .\
BACKGROUND	Receptorantagonists like Montelukast constitute a well-established asthma - and ASA intolerance-therapy .\
BACKGROUND	The aim of our study was to evaluate changes in patients Health-Related-Quality-of-Life ( HRQL ) during Montelukast-monotherapy of nasal polyposis .\
METHODS	The study was performed in a prospective , double blind and placebo-controlled matter .\
METHODS	The study included 30 patients of our ENT outpatient 's dept. ( 77 % male , mean age 49 yrs ) , suffering from nasal polyposis grade II to IV .\
METHODS	Polyps were endoscopically graded , nasal Eosinophilic Cationic Protein ( ECP ) was measured , and HRQL-score was taken prior to and four weeks after Montelukast - ( 0 - 0 - 10 mg ) compared to placebo .\
METHODS	An established HRQL-questionnaire - including 25 items , summarized in 6 symptom-groups - was used .\
METHODS	Given was a symptom-score of 1 ( not troubled ) to 4 ( extremely troubled ) .\
RESULTS	Patients treated with Montelukast improved their nasal symptoms ( Delta HRQL-score 0.58 + / - 0.94 , P < 0.01 ) , practical problems ( Delta HRQL-score 0.42 + / - 0.71 , P < 0.05 ) , headaches ( Delta HRQL-score 0.38 + / - 0.56 , P < 0.05 ) , non-nasal symptoms ( Delta HRQL-score 0.35 + / - 0.92 , P < 0.05 ) , sleep ( Delta HRQL-score 0.26 + / - 0.71 ) and emotional problems ( Delta HRQL-score 0.18 + / - 0.75 ) .\
RESULTS	Intranasal ECP ( Delta 210.67 ng/ml + / - 332.68 ) and polyp grading ( Delta 0.72 + / - 1.77 ) tended to improve as well , but did not reach statistical significance .\
RESULTS	Patients treated with placebo revealed no significant changes neither in HRQL-score , ECP , nor polyp grading .\
CONCLUSIONS	Montelukast-therapy of nasal polyposis significantly improved patient 's HRQL in 4 out of 6 symptom-groups .\
CONCLUSIONS	Measuring HRQL proofed to constitute a more sensitive tool than looking at eosinophilic parameters of inflammation or polyp size .\
\
###25977128\
BACKGROUND	Checklists may help reduce discharge errors ; however , current paper checklists have limited functionality .\
BACKGROUND	In 2013 a best-practice discharge checklist using the electronic health record ( EHR ) was developed and evaluated at Stanford University Medical Center ( Stanford , California ) in a cluster randomized trial to evaluate its usage , user satisfaction , and impact on physicians ' work flow .\
METHODS	The study was divided into four phases .\
RESULTS	In Phase I , on the survey ( N = 76 ) , most of the participants ( 54.0 % ) reported using memory to remember discharge tasks .\
RESULTS	On a 0-100 scale , perception of checklists as being useful was strong ( mean , 66.4 ; standard deviation [ SD ] , 21.2 ) , as was interest in EHR checklists ( 64.5 , 26.6 ) .\
RESULTS	In Phase II , the checklist consisted of 15 tasks categorized by admission , hospitalization , and discharge-planning .\
RESULTS	In Phase III , the checklist was implemented as an EHR `` smart-phrase '' allowing for automatic insertion .\
RESULTS	In Phase IV , in a trial with 60 participating physicians , 23 EHR checklist users reported higher usage than 12 paper users ( 28.5 versus 7.67 , p = .019 ) , as well as higher checklist integration with work flow ( 22.6 versus 1.67 , p = .014 ) , usefulness of checklist ( 33.7 versus .\
RESULTS	8.92 , p = .041 ) , discharge confidence ( 30.8 versus 5.00 , p = .029 ) , and discharge efficiency ( 25.5 versus 6.67 , p = .056 ) .\
RESULTS	Increasing EHR checklist use was correlated with usefulness ( r = .85 , p < .001 ) , confidence ( r = .81 , p < .001 ) , and efficiency ( r = .87 , p < .001 ) .\
CONCLUSIONS	The EHR checklist reminded physicians to complete discharge tasks , improved confidence , and increased process efficiency .\
CONCLUSIONS	This is the first study to show that medicine residents use `` memory '' as the most common method for remembering discharge tasks .\
CONCLUSIONS	These data reinforce the need for a formalized tool , such as a checklist , that residents can rely on to complete important discharge tasks .\
\
###22831283\
BACKGROUND	Alterations in intestinal microflora have been linked to the development of allergic disease .\
BACKGROUND	Recent studies suggest that healthy infant immune development may depend on the establishment of a diverse gut microbiota rather than the presence or absence of specific microbial strains .\
OBJECTIVE	We investigated the relationship between diversity of gut microbiota in the early postnatal period and subsequent development of eczema and atopy in the first year of life .\
METHODS	Fecal samples were collected 1 wk after birth from 98 infants at high risk of allergic disease , who were followed prospectively to age 12 months .\
METHODS	Fecal microbial diversity was assessed by terminal restriction fragment length polymorphism ( T-RFLP ) using restriction enzymes Sau96I and AluI , with a greater number of peaks representing greater diversity of bacterial communities .\
RESULTS	Microbial diversity at day 7 was significantly lower in infants with eczema at age 12 months as compared to infants without eczema ( AluI mean number of peaks 13.1 vs. 15.5 , p = 0.003 , 95 % CI for difference in means -3.9 , -0.8 ; Sau96I 14.7 vs. 17.2 , p = 0.03 , 95 % CI -4.9 , -0.3 ) .\
RESULTS	No differences were observed for atopic compared to non-atopic infants , or infants with two allergic parents compared to those with one or no allergic parent .\
CONCLUSIONS	A more diverse intestinal microbiota in the first week of life is associated with a reduced risk of subsequent eczema in infants at increased risk of allergic disease .\
CONCLUSIONS	Interventions that enhance microbial diversity in early life may provide an effective means for the prevention of eczema in high-risk infants .\
\
###17305759\
BACKGROUND	Two-thirds of proton pump inhibitor prescribing in the UK is for long-term therapy .\
OBJECTIVE	To determine the impact of eradication in long-term proton pump inhibitor users infected with Helicobacter pylori .\
METHODS	A total of 184 H. pylori-positive patients were randomly assigned to true or placebo eradication therapy .\
METHODS	The primary outcome was the change in proton pump inhibitor usage measured by prescriptions ; secondary outcomes were changes of proton pump inhibitor doses , dyspepsia symptoms , general practitioner consultations and quality of life measures .\
RESULTS	In the year following H. pylori eradication proton pump inhibitor prescriptions fell compared with placebo ( -1.7 , 95 % CI : -2.3 to -1.1 , P < 0.001 ) ; when adjusted to full-dose equivalent prescriptions the reduction was more marked ( -2.2 , 95 % CI : -3.0 to -1.4 , P < 0.001 ) .\
RESULTS	Both general practitioner consultations ( -1.0 , 95 % CI : -1.8 to -0.1 , P = 0.026 ) and symptoms measured on the Leeds Dyspepsia Questionnaire ( -3.1 , 95 % CI : -5.3 to -0.9 , P = 0.005 ) were reduced .\
RESULTS	Quality of life and self-rating measures also favoured eradication ( EQ-5D : 0.09 , P = 0.08 and VAS : 5.6 , P = 0.002 ) .\
RESULTS	The Carlsson and Dent Reflux Questionnaire found no difference between groups ( -0.3 , P = 0.65 ) , possibly balancing decreased overall symptoms with increased prominence of heartburn in the eradication group .\
CONCLUSIONS	Helicobacter pylori eradication in infected , long-term proton pump inhibitor users in primary care reduced both the overall severity of symptoms and use of health care .\
\
###8341188\
OBJECTIVE	To compare the efficacy of salbutamol as a fixed dose Ventolin Nebule ( 2.5 mg ) and as variable dose respirator solution ( 0.1 mg/kg bodyweight ) .\
METHODS	Multicentre , randomised , double-blind , parallel group comparison .\
METHODS	The Emergency Departments of the Royal Children 's Hospital , Melbourne , Victoria ; Princess Margaret Hospital for Children , Perth , Western Australia ; and The Children 's Hospital , Sydney , New South Wales .\
METHODS	Ninety-nine children between four and 12 years of age who presented to the Emergency Departments with mild to moderate acute asthma from May to December 1990 .\
METHODS	Children enrolled in the study were randomly allocated to one of two groups .\
METHODS	Group 1 received one Nebule ( 2.5 mg salbutamol in 2.5 mL aqueous solution ) delivered by wet nebulisation .\
METHODS	Group 2 received salbutamol ( approximately 0.1 mg/kg bodyweight ) diluted with saline to 2.5 mL , delivered by identical wet nebulisation .\
METHODS	( i ) Clinical score ; ( ii ) pulse oximetry ; and ( iii ) peak expiratory flow rate ( PEFR ) where possible -- measured before , and at 15 and 30 minutes after treatment with salbutamol .\
RESULTS	The clinical score significantly improved in both treatment groups after 15 minutes ( P < 0.001 ) , but the difference between the two treatments ( adjusted for covariates ) was not significant ( P = 0.97 ) .\
RESULTS	Both preparations of salbutamol produced a significant increase in oxygen saturation after 15 minutes ( P < 0.05 ) , while the difference between the two treatments ( adjusted means ) was not significant ( P = 0.46 ) .\
RESULTS	Peak flow measurements were available for 65 of the 99 patients .\
RESULTS	Both preparations of salbutamol produced highly significant ( P < 0.001 ) improvements in PEFR at 15 minutes after treatment .\
RESULTS	The difference in peak flow rates between the two treatment groups ( adjusted means ) was not significant ( P = 0.89 ) .\
RESULTS	The study had a power of 0.8 to detect differences between treatments of 9 % PEFR ( percentage predicted ) , 0.8 % oxygen saturation and 0.77 units of clinical score .\
CONCLUSIONS	A fixed dose of nebulised salbutamol is as efficacious as a salbutamol dose calculated for bodyweight in children with mild to moderate acute asthma .\
\
###16317061\
BACKGROUND	By enhancing energy expenditure and suppressing appetite , melanocortin peptides derived from proopiomelanocortin play a primary role in the hypothalamic regulation of body weight .\
BACKGROUND	In a recent study in normal-weight adults , the 6-wk intranasal administration of the MSH/ACTH ( 4-10 ) core fragment of proopiomelanocortin resulted in a distinct reduction of body weight and body fat , accompanied by significant decreases in leptin and insulin plasma concentrations .\
OBJECTIVE	The present study aimed to generalize this finding to overweight patients .\
METHODS	MSH/ACTH ( 4-10 ) ( 0.5 mg ) and placebo were intranasally administered once in the morning and once in the evening over a period of 12 wk in 23 overweight men ( body mass index , mean + / - sem : 29.72 + / - 0.43 kg/m ( 2 ) ) .\
RESULTS	MSH/ACTH ( 4-10 ) did not induce any significant reduction in body weight , body fat , and plasma levels of insulin and leptin as compared with the effects of placebo .\
RESULTS	Melanocortin treatment was accompanied by reduced cortisol concentrations .\
CONCLUSIONS	We conclude that contrasting with normal-weight humans , overweight subjects are not susceptible to the effects of melanocortin administration on hypothalamic weight regulatory systems .\
CONCLUSIONS	In overweight subjects , a decreased sensitivity to ACTH/MSH peptides may derive from alterations at the level of the melanocortin receptor or at subsequent steps in the processing of the body fat signal .\
\
###25667293\
OBJECTIVE	To assess whether urea-based cream ( UBC ) has prophylactic benefits on sorafenib-induced hand-foot skin reaction ( HFSR ) in patients with advanced hepatocellular carcinoma ( HCC ) .\
METHODS	In this randomized , open-label trial , 871 patients with advanced HCC throughout China were treated with 10 % UBC three times per day plus best supportive care ( BSC ; n = 439 ) or BSC alone excluding all creams ( n = 432 ) , starting on day 1 of sorafenib treatment , for up to 12 weeks .\
METHODS	HFSR was assessed every 2 weeks and at 14 weeks for patients completing the study .\
METHODS	Once HFSR occurred , patients were allowed any cream , including a UBC .\
RESULTS	The 12-week incidence of any grade HFSR was significantly lower in the UBC group versus the BSC-alone group ( 56.0 % v 73.6 % , respectively ; odds ratio [ OR ] , 0.457 ; 95 % CI , 0.344 to 0.608 ; P < .001 ) , as was the incidence of grade 2 HFSR ( 20.7 % v 29.2 % , respectively ; OR , 0.635 ; 95 % CI , 0.466 to 0.866 ; P = .004 ) .\
RESULTS	Median time to first occurrence of HFSR was significantly longer in the UBC group than the BSC-alone group ( 84 v 34 days , respectively ; hazard ratio , 0.658 ; 95 % CI , 0.541 to 0.799 ; P < .001 ) .\
RESULTS	Elevated AST was associated with increased risk of HFSR but did not alter the treatment effect of UBC .\
RESULTS	UBC plus BSC , compared with BSC alone , did not affect the sorafenib dose reduction or interruption rate ( 9.1 % v 11.8 % , respectively ; P = .1937 ) , response rate ( 11.1 % v 10.1 % , respectively ; P = .6674 ) , or disease control rate ( 98.8 % v 98.2 % , respectively ; P = .5350 ) at week 12 .\
CONCLUSIONS	UBC prophylaxis in patients with advanced HCC starting sorafenib reduced HFSR rates , extended the time to first occurrence of HFSR , and improved patient quality of life compared with BSC .\
CONCLUSIONS	Blinded , randomized , placebo-controlled trials to determine the role of UBC on the incidence and severity of HFSR are warranted .\
\
###17631801\
OBJECTIVE	To evaluate the efficacy and safety of Dinggui Oil Capsule in treating irritable bowel syndrome ( IBS ) with stagnation of qi and cold .\
METHODS	A prospective , randomized , placebo-controlled , double-blind clinical study was undertaken .\
METHODS	One hundred and ninety-eight patients with IBS and syndrome of stagnation of qi and cold were randomly divided into high-dose Dinggui Oil group ( DGO-H , 1.2 g , 3 times daily ; n = 66 ) , low-dose Dinggui Oil group ( DGO-L , 0.8 g , 3 times daily , n = 66 ) , and placebo group ( placebo , 5.0 g , 3 times daily , n = 66 ) .\
METHODS	Patients in the three groups were all treated for 2 weeks .\
RESULTS	The total significant effective rates for IBS were 54.1 % , 28.8 % and 21.9 % in the DGO-H , DGO-L , and placebo groups , and the total effective rates for the syndrome of stagnation of qi and cold were 54.1 % , 25.8 % and 23.4 % in the three groups , respectively .\
RESULTS	Dinggui Oil Capsule showed a higher efficacy than the placebo in relieving the abdominal pain ( P < 0.01 ) .\
RESULTS	No adverse effects were found in this trial .\
CONCLUSIONS	Dinggui Oil Capsule is effective and safe in relieving abdominal pain due to IBS with stagnation of qi and cold .\
\
###17257456\
OBJECTIVE	To compare the efficacy and safety of cefdinir to that of cephalexin in adolescents and adults with mild to moderate uncomplicated skin and skin structure infections ( USSSI ) .\
METHODS	This was an investigator-blinded , multicenter study in which patients at least 13 years of age with USSSI were randomized to receive 10 days of cefdinir 300 mg twice daily ( BID ) or cephalexin 250 mg four times daily ( QID ) .\
METHODS	Patients were evaluated at baseline , by telephone on Days 3-5 , and during office visits on Days 12-14 ( end-of-therapy [ EOT ] visit ) and Days 17-24 ( test-of-cure [ TOC ] visit ) .\
METHODS	Clinical response was evaluated at the TOC visit .\
METHODS	Patient reported outcomes , including a usefulness questionnaire , were also assessed .\
RESULTS	Three hundred and ninety-one patients were treated .\
RESULTS	The treatment groups were well matched with regard to demographic characteristics and types of infection .\
RESULTS	Abscess ( es ) ( 26 % ) , wound infection ( 24 % ) , and cellulitis ( 21 % ) were the most common infections .\
RESULTS	At the TOC visit , the clinical cure rate for both treatment groups was 89 % ( 151/170 for cefdinir and 154/174 for cephalexin ) in clinically evaluable patients ( 95 % CI for difference in cure rates [ -6.7 to 7.3 ] ) .\
RESULTS	In the intent-to-treat analysis , cure rates were 83 % for cefdinir vs. 82 % for cephalexin .\
RESULTS	Clinical cure rates for infections caused by methicillin-susceptible ( MSSA ) and methicillin-resistant ( MRSA ) Staphylococcus aureus were 93 % ( 37/40 ) and 92 % ( 35/38 ) for cefdinir vs. 91 % ( 29/32 ) and 90 % ( 37/41 ) for cephalexin ( p > 0.999 comparing treatment groups for MSSA ; p > 0.999 for MRSA ) .\
RESULTS	The usefulness questionnaire demonstrated that cefdinir was more highly rated in the mean composite score ( 87.4 vs. 83.6 , p = 0.04 ) , with the difference primarily due to the respondents ' preference for the convenience of taking the study medication ( mean score 93.5 vs. 74.1 for cephalexin , p < 0.001 ) .\
RESULTS	The study had the following limitations : the requirement for culture at baseline likely skewed the enrollment of patients towards those with abscesses ; the results of culture in patients with USSSIs are often nonspecific ; in some patients entering the study with a diagnosis of cellulitis , the cellulitis was associated with an abscess ; and , incision and drainage ( I&D ) , spontaneous drainage , and needle aspiration are likely to have contributed to clinical response for purulent infections , and in particular MRSA-associated infections .\
RESULTS	Both study drugs were well tolerated .\
RESULTS	The most common treatment-related adverse events were diarrhea ( 10 % cefdinir , 4 % cephalexin , p = 0.017 ) , nausea ( 3 % and 6 % , respectively , p = 0.203 ) , and vaginal mycosis ( 3 % and 6 % of females , respectively , p = 0.500 ) .\
CONCLUSIONS	This study demonstrated that empiric coverage of USSSIs with cephalosporin therapy remains an appropriate clinical strategy .\
CONCLUSIONS	MRSA infections responded well in both arms of the study , suggesting that the choice of a cephalosporin did not adversely affect patient outcome .\
CONCLUSIONS	However , cephalosporins do not have accepted , clinically relevant in vitro activity against MRSA .\
CONCLUSIONS	Hence , the clinical response rates seen in this study against MRSA infections must be interpreted with caution .\
CONCLUSIONS	Cefdinir was more highly rated than cephalexin in a composite usefulness assessment .\
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###16030279\
BACKGROUND	Renal dysfunction is a complication of coronary artery bypass graft ( CABG ) surgery performed with cardiopulmonary bypass ( CPB ) that is associated with increased morbidity and mortality .\
BACKGROUND	N-acetylcysteine , an antioxidant and vasodilator , counteracts renal ischemia and hypoxia .\
OBJECTIVE	To determine whether perioperative intravenous ( IV ) N-acetylcysteine preserves renal function in high-risk patients undergoing CABG surgery with CPB compared with placebo .\
METHODS	Randomized , quadruple blind , placebo-controlled trial ( October 2003-September 2004 ) in operating rooms and general intensive care units ( ICUs ) of 2 Ontario tertiary care centers .\
METHODS	The 295 patients required elective or urgent CABG and had at least 1 of the following : preexisting renal dysfunction , at least 70 years old , diabetes mellitus , impaired left ventricular function , or undergoing concomitant valve or redo surgery .\
METHODS	Patients received 4 ( 2 intraoperative and 2 postoperative ) doses of IV N-acetylcysteine ( 600 mg ) ( n = 148 ) or placebo ( n = 147 ) over 24 hours .\
METHODS	The primary outcome was the proportion of patients developing postoperative renal dysfunction , defined by an increase in serum creatinine level greater than 0.5 mg/dL ( 44 micromol/L ) or a 25 % increase from baseline within the first 5 postoperative days .\
METHODS	Secondary outcomes included postoperative interventions and complications , the requirement for renal replacement therapy ( RRT ) , adverse events , hospital mortality , and ICU and hospital length of stay .\
RESULTS	There was no difference in the proportion of patients with postoperative renal dysfunction ( 29.7 % vs 29.0 % , P = .89 ; relative risk [ RR ] , 1.03 [ 95 % confidence interval \{ CI \} , 0.72-1 .46 ] ) in the N-acetylcysteine and placebo groups , respectively .\
RESULTS	We noted nonsignificant differences in postoperative interventions and complications , the need for RRT ( 0.7 % vs 2.1 % ; P = .37 ) , total ( 6.1 % vs 9.6 % ; P = .26 ) and serious adverse events , hospital mortality ( 3.4 % vs 2.7 % ; P > .99 ) , and ICU and hospital length of stay between the N-acetylcysteine and placebo groups .\
RESULTS	A post hoc subgroup analysis of patients ( baseline creatinine level > 1.4 mg/dL [ 120 micromol/L ] ) showed a nonsignificant trend toward fewer patients experiencing postoperative renal dysfunction in the N-acetylcysteine group compared with the placebo group ( 25.0 % vs 37.1 % ; P = .29 ) .\
CONCLUSIONS	N-acetylcysteine did not prevent postoperative renal dysfunction , interventions , complications , or mortality in high-risk patients undergoing CABG surgery with CPB .\
CONCLUSIONS	Further research is required to identify CABG patients at risk for postoperative renal events , valid markers of renal dysfunction , and to establish renal thresholds associated with important clinical outcomes .\
\
###15084901\
BACKGROUND	Major depression is a common comorbid condition among individuals with alcohol dependence .\
BACKGROUND	This study examined the effects of nefazodone , a norepinephrine and serotonin reuptake blocker and 5-hydroxytryptamine-2 receptor antagonist , on mood and anxiety symptoms and drinking behavior in a sample of depressed alcoholics .\
METHODS	This study was a double-blind , placebo-controlled comparison of nefazodone ( 200-600 mg/day ) or placebo in a sample of alcohol-dependent subjects ( n = 41 ; 52 % women ) with current major depression .\
METHODS	After a 1-week placebo lead-in period , subjects were randomly assigned to receive study medication and supportive psychotherapy for 10 weeks .\
RESULTS	Depressive and anxiety symptoms declined significantly over time .\
RESULTS	Although the nefazodone group showed greater reductions in these symptoms , the effects did not reach statistical significance .\
RESULTS	Nonetheless , nefazodone-treated subjects showed a significantly greater reduction in heavy drinking days and in total drinks compared with placebo-treated subjects .\
CONCLUSIONS	The lack of significant effects on depression and anxiety symptoms may reflect limited statistical power .\
CONCLUSIONS	Despite the small sample size , nefazodone significantly reduced some measures of alcohol consumption in this sample of depressed alcoholics .\
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###11894174\
OBJECTIVE	Symptomatic patients with multivessel coronary disease ( MVD ) benefit from both coronary artery bypass grafting ( CABG ) and percutaneous coronary angioplasty ( PTCA ) .\
OBJECTIVE	The >> German Angioplasty Bypass Investigation << ( GABI-I ) trial randomized patients to one of these treatment strategies between 1986 and 1991 .\
OBJECTIVE	In order to evaluate the impact of current technology , in particular coronary stents , the GABI-II trial was initiated , which in 1996 and 1997 prospectively enrolled patients according to the initial GABI-I criteria .\
METHODS	Into the study 136 consecutive patients ( 108 men , 28 women ; 63 + / - 12 years ) were included .\
METHODS	Patients from GABI-I served as controls .\
RESULTS	A mean of 2.1 + / - 0.5 vessels were treated per patient ( vs. 1.9 + / - 0.5 vessels in the PTCA arm of GABI-I ) and 63 % of the lesions were covered with stents .\
RESULTS	With respect to the primary endpoint less patients remained with a CCS class III or IV in GABI-II after 12 months ( 1,5 % vs. 8 % in the PTCA arm of GABI-I , p < 0,01 ) .\
RESULTS	No patient required emergency or urgent bypass operation in GABI-II ( vs. 9 % in GABI-I , p < 0.01 ) .\
RESULTS	After 12 months , 8 % of the patients were sent for bypass surgery ( CABG ) vs. 21 % in GABI-I ( p < 0.001 ) , and 20 % ( vs. 23 % in GABI-I ) of the patients underwent Re-PTCA .\
RESULTS	The percentage of patients without reinterventions was 72 % vs. 56 % in GABI-I ( p < 0.01 ) , but remained lower compared to patients randomized to CABG in GABI-I ( 94 % , p < 0.001 ) .\
CONCLUSIONS	PTCA in patients with MVD is still associated with a higher reintervention rate as compared with CABG .\
CONCLUSIONS	However , in contrast to angioplasty a decade ago , PTCA in conjunction with stents significantly lowered the need for subsequent revascularization , which was mainly driven by the reduced necessity for bypass surgery .\
\
###25831599\
OBJECTIVE	To compare the efficacy of an oscillating-rotating power toothbrush with a novel brush head incorporating angled CrissCross bristles ( Oral-B Pro 7000 SmartSeries and Oral-B CrossAction brush head ) versus a marketed sonic toothbrush ( Colgate ProClinical A1500 with the Triple Clean brush head ) in the reduction of gingivitis and plaque over a 6-week period .\
METHODS	This was a single center , randomized , open label , examiner-blind , 2-treatment , parallel group study .\
METHODS	Study participants who met the entrance criteria were enrolled in the study and randomly assigned to one of the two toothbrush groups .\
METHODS	Study participants brushed with their assigned toothbrush and a marketed fluoride dentifrice for 2 minutes twice daily at home for 6 weeks .\
METHODS	Gingivitis and plaque were evaluated at baseline and Week 6 .\
METHODS	Gingivitis was assessed using the Modified Gingival Index ( MGI ) and Gingival Bleeding Index ( GBI ) and plaque was assessed using the Rustogi Modified Navy Plaque Index ( RMNPI ) .\
METHODS	Data was analyzed using the ANCOVA with baseline as the covariate .\
RESULTS	In total , 130 study participants were randomized to treatment resulting in 64 study participants per group completing the study .\
RESULTS	Both brushes produced statistically significant ( P < 0.001 ) reductions in gingivitis and plaque measures relative to baseline .\
RESULTS	The oscillating-rotating , brush with the novel brush head demonstrated statistically significantly ( P < 0.05 ) greater reductions in all gingivitis measures , as well as whole mouth and interproximal plaque measures , compared to the sonic toothbrush .\
RESULTS	The benefit for the oscillating - rotating brush over the sonic brush was 21.3 % for gingivitis , 35.7 % for gingival bleeding , 34.7 % for number of bleeding sites , 17.4 % for whole mouth plaque , and 21.2 % for interproximal plaque .\
RESULTS	There were no adverse events reported or observed for either brush .\
\
###22867111\
BACKGROUND	Osteoarthritis ( OA ) is a common health issue worldwide in the aging population who are also commonly deficient in vitamin D.\
BACKGROUND	Our previous study suggested that higher serum 25 - ( OH ) D levels were associated with reduced knee cartilage loss , implying that vitamin D supplementation may prevent the progression of knee OA .\
BACKGROUND	The aim of the VItamin D Effects on OA ( VIDEO ) study is to compare , over a 2 - year period , the effects of vitamin D supplementation versus placebo on knee structural changes , knee pain , and lower limb muscle strength in patients with symptomatic knee OA .\
METHODS	Randomised , placebo-controlled , and double-blind clinical trial aiming to recruit 400 subjects ( 200 from Tasmania and 200 from Victoria ) with both symptomatic knee OA and vitamin D deficiency ( serum [ 25 - ( OH ) D ] level of > 12.5 nmol/liter and < 60nmol/liter ) .\
METHODS	Participants will be randomly allocated to vitamin D supplementation ( 50,000 IU compounded vitamin D3 capsule monthly ) or identical inert placebo group for 2years .\
METHODS	The primary endpoint is loss of knee cartilage volume measured by magnetic resonance imaging ( MRI ) and Western Ontario and McMaster Universities Index of OA ( WOMAC ) knee pain score .\
METHODS	The secondary endpoints will be other knee structural changes , and lower limb muscle strength .\
METHODS	Several other outcome measures including core muscle images and central blood pressure will be recorded .\
METHODS	Linear and logistic regression will be used to compare changes between groups using univariable and multivariable modeling analyses .\
METHODS	Both intention to treat and per protocol analyses will be utilized .\
CONCLUSIONS	The trial is designed to test if vitamin D supplementation will reduce loss of knee cartilage volume , prevent the progression of other knee structural abnormalities , reduce knee pain and strengthen lower limb muscle strength , thus modify disease progression in knee OA .\
BACKGROUND	ClinicalTrials.gov identifier : NCT01176344 ; Australian New Zealand Clinical Trials Registry : ACTRN12610000495022 .\
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###23416219\
OBJECTIVE	To determine the impact of a restorative model of home care on social support and physical function among community-dwelling older people .\
METHODS	Cluster-randomized controlled trial .\
METHODS	Home care in an urban area .\
METHODS	Participants ( N = 205 ) were randomly assigned to an intervention group ( n = 108 ; mean age , 79.1 y ; 71.3 % women ; 81.5 % New Zealand European [ NZE ] ; 50.8 % residing in areas of the highest levels of social deprivation ) or a usual care group ( n = 97 ; mean age , 76.9 y ; 60.8 % women ; 73.2 % NZE ; 53.5 % in the highest levels of social deprivation ) .\
METHODS	Participants randomly assigned to the intervention group completed a goal facilitation tool with a needs assessor to determine their needs and to establish the aims for the episode of care .\
METHODS	Services were structured according to the principles of restorative home care ( independence focused with individually tailored activity programs ) .\
METHODS	Usual care participants received a standard needs assessment that informed the delivery of home care services .\
METHODS	Short Physical Performance Battery ( SPPB ) , Dukes Social Support Index ( DSSI ) .\
RESULTS	There was greater change over time in physical function ( measured by SPPB : F = 8.30 , P = .003 ) but no associated increase in social support ( as determined by DSSI : F = 2.58 , P = .09 ) .\
CONCLUSIONS	Significant improvements in physical function were observed after a period of restorative home care services .\
CONCLUSIONS	The absence of an associated change in social support may have been the result of a combination of factors , including the threshold of physical function required for community ambulation , the low rate of allied health service provision , and the time required to reestablish social ties .\
CONCLUSIONS	The findings contribute to a greater understanding of factors necessary to refocus home-based services to emphasize improvements in physical function and independence .\
\
###8090921\
OBJECTIVE	To determine if hepatic metastases can be distinguished from cavernous hemangiomas by pattern analysis of magnetic resonance ( MR ) images obtained prior to and following administration of gadoteridol at standard ( 0.1 mmol/kg ) and triple ( 0.3 mmol/kg ) doses .\
METHODS	Ninety-five patients with proved hepatic metastases ( n = 71 ) or cavernous hemangiomas ( n = 24 ) underwent MR imaging at 16 different institutions .\
METHODS	T2-weighted spin-echo and T1-weighted images were obtained before and after gadoteridol administration .\
METHODS	Two independent blinded reviewers rated individual features of benignancy versus malignancy on a five-point confidence scale .\
RESULTS	The most useful diagnostic features , with 100 % specificity , were nodular enhancement for hemangiomas and rim enhancement for metastases .\
RESULTS	Confident ( definitely benign or definitely malignant ) diagnoses were rendered in 80 of 95 cases ( 84 % ) , with an accuracy of a confident diagnosis of 96 % .\
CONCLUSIONS	The pattern of enhancement on T1-weighted images is highly accurate for distinction between hemangiomas and metastases in images obtained with both doses .\
\
###20813583\
OBJECTIVE	To assess the efficacy of rotigotine transdermal patch in subjects with moderate to severe idiopathic restless legs syndrome ( RLS ) and periodic limb movement ( PLM ) in sleep in a double-blind , randomized , placebo-controlled , multicenter study ( NCT00275236 ) .\
METHODS	Sixty-seven ( 46 rotigotine , 21 placebo ) subjects applied rotigotine ( maximum 3mg/24h ) or placebo patches once-daily during a 4-week maintenance period ; efficacy evaluations used polysomnographic measures and clinician/patient ratings .\
RESULTS	Mean PLM index ( PLMI ; PLM/h time in bed ) decreased more with rotigotine ( 50.9 / h to 8.1 / h ) than with placebo ( 37.4 / h to 27.1 / h ; adjusted treatment ratio 4.25 ( 95 % CI [ 2.48,7.28 ] , p < 0.0001 ) .\
RESULTS	PLM during sleep with arousal index ( PLMSAI ; 8.57 / h to 2.47 / h under rotigotine , 6.5 / h to 4.95 / h under placebo ; adjusted treatment difference : -3.12 ( 95 % CI [ -5.36 , -0.88 ] , p = 0.0072 ) also improved more under rotigotine .\
RESULTS	At end of maintenance , 39 % of rotigotine subjects had PLMI levels < 5/h and 26 % showed no RLS symptoms ( IRLS = 0 ) , whereas no placebo subject met these criteria .\
RESULTS	Common drug-related adverse events for rotigotine and placebo included nausea ( 21.7 % / 4.8 % ) , headache ( 17.4 % / 14.3 % ) , application site reactions ( 17.4 % / 4.8 % ) , and somnolence ( 10.9 % / 9.5 % ) ; most were mild to moderate in intensity .\
CONCLUSIONS	Rotigotine transdermal patch was efficacious and well tolerated in the short-term treatment of RLS motor symptoms and associated sleep disturbances .\
\
###24628438\
BACKGROUND	Until now , working memory training has not reached sufficient evidence as effective treatment for ADHD core symptoms in children with ADHD ; for young children with ADHD , no studies are available .\
BACKGROUND	To this end , a triple-blind , randomized , placebo-controlled study was designed to assess the efficacy of Cogmed Working Memory Training ( CWMT ) in young children with ADHD .\
METHODS	Fifty-one children ( 5-7years ) with a DSM-IV-TR diagnosis of ADHD ( without current psychotropic medication ) were randomly assigned to the active ( adaptive ) or placebo ( nonadaptive ) training condition for 25 sessions during 5 weeks .\
METHODS	The compliance criterion ( > 20 sessions ) was met for 47 children .\
METHODS	The primary outcome measure concerned the core behavioural symptoms of ADHD , measured with the ADHD Rating Scale IV ( ADHD-RS ) .\
METHODS	Secondary outcome measures were neurocognitive functioning , daily executive functioning , and global clinical functioning .\
METHODS	The influence of the increase in difficulty level ( Index-Improvement ) for the treatment group was also analysed .\
METHODS	Clinical trial registration information - ` Working Memory Training in Young ADHD Children ' ; www.clinicaltrials.gov ; NCT00819611 .\
RESULTS	A significant improvement in favour of the active condition was found on a verbal working memory task ( p = .041 ; adapted Digit Span WISC-III , backward condition ) .\
RESULTS	However , it did not survive correction for multiple testing .\
RESULTS	No significant treatment effect on any of the primary or other secondary outcome measurements was found .\
RESULTS	The Index-Improvement significantly contributed to ADHD-RS and the Behavior Rating Inventory of Executive Function , both rated by the teacher , but revealed no significant group difference .\
CONCLUSIONS	This study failed to find robust evidence for benefits of CMWT over the placebo training on behavioural symptoms , neurocognitive , daily executive , and global clinical functioning in young children with ADHD .\
\
###20467623\
OBJECTIVE	To compare immediate versus early ( 6 weeks ) non-occlusal loading of dental implants placed flapless in partially edentulous patients 1 year after loading .\
METHODS	Sixty patients were randomised : 30 to the immediately loaded group and 30 to the early loaded group .\
METHODS	In order to be immediately loaded , implants were inserted with a minimum torque of > or = 40Ncm .\
METHODS	Implants were fully occlusally loaded after 6 months .\
METHODS	Outcome measures were prosthesis and implant failures , and biological and biomechanical complications .\
RESULTS	Five implants in five patients randomised to the immediately loaded group did not reach the required primary implant stability .\
RESULTS	Three of these implants ( two prostheses ) were not immediately loaded .\
RESULTS	Two patients who were randomised to the early loaded group were immediately loaded erroneously .\
RESULTS	Implants in five patients of the early loaded group were conventionally loaded .\
RESULTS	No patient dropped out and there were no failures .\
RESULTS	Two complications occurred in the early and one in the immediately loaded group ( no statistically significant difference ) , but were solved .\
CONCLUSIONS	The use of a flapless technique for placing dental implants in conjunction with non-occlusal immediate or early loading in selected patients can provide excellent clinical results .\
CONCLUSIONS	No differences were observed when comparing implants that were loaded immediately or early .\
CONCLUSIONS	Therefore , when a high primary implant stability is obtained , it might be preferable to load the implants immediately rather than waiting for a few weeks .\
\
###17050867\
OBJECTIVE	Trials combining irinotecan/docetaxel and irinotecan/gemcitabine in second-line treatment of non-small-cell lung cancer ( NSCLC ) have yielded promising results .\
OBJECTIVE	Preliminary data suggested that the selective cyclooxygenase -2 inhibitor celecoxib ( CBX ) might enhance efficacy of chemotherapeutic regimens .\
OBJECTIVE	This multicenter , phase II , randomized trial investigated efficacy and safety of irinotecan and docetaxel and irinotecan and gemcitabine , with or without CBX , in second-line treatment of NSCLC .\
METHODS	Patients 18 years or older were randomly assigned to receive irinotecan 60 mg/m2 and docetaxel 35 mg/m2 , or irinotecan 100 mg/m2 and gemcitabine 1,000 mg/m2 , with or without CBX 400 mg twice daily , for four cycles .\
METHODS	Primary efficacy end points were median and 1-year survival probabilities .\
METHODS	Patient-reported symptoms were assessed by the Lung Cancer Symptoms Scale ( LCSS ) .\
RESULTS	A total of 133 patients were assessable for efficacy and safety .\
RESULTS	Median survival time was 6.31 months for patients treated with CBX and 8.99 months for those treated with chemotherapy alone .\
RESULTS	One-year survival rates were 24 % and 36 % respectively .\
RESULTS	The overall toxicity rates and LCSS scores were similar between patients treated or not treated with CBX .\
RESULTS	Four deaths were considered possibly treatment related .\
CONCLUSIONS	Survival results for the second-line regimens in this study were similar to results reported for single-agent therapy in this setting .\
CONCLUSIONS	CBX did not appear to enhance efficacy or improve patient-reported symptoms .\
CONCLUSIONS	The addition of high-dose CBX to second-line chemotherapy in NSCLC can not be recommended .\
\
###20224951\
BACKGROUND	Premedication aims at alleviating preoperative anxiety and nervousness and also at minimizing adverse effects .\
BACKGROUND	To our knowledge there is no study comparing efficacy and patient satisfaction of different premedications in age-adjusted dosage .\
METHODS	In 139 patients anxiety , sedation and adverse effects were measured at 6 consecutive perioperative time points after administration of midazolam , clonidine or a placebo .\
RESULTS	Midazolam showed the strongest sedative and anxiolytic effects , clonidine less and placebo none .\
RESULTS	Clonidine and midazolam reduced the risk of postoperative nausea and vomiting ( PONV ) .\
RESULTS	Midazolam showed minimal adverse effects and the best patient satisfaction .\
CONCLUSIONS	Midazolam was the most anxiolytic , sedative and favored premedication with the least adverse effects .\
CONCLUSIONS	Most patients would choose midazolam next time .\
\
###17966026\
BACKGROUND	Pain management after surgery has been used as a sales argument for the use of COX-2 inhibitors , but their potential positive and negative effects have not been fully investigated .\
BACKGROUND	We thus conducted a controlled evaluation of the effect of celecoxib on perioperative blood loss , pain relief and consumption of analgesics , range of motion , and subjective outcome in conjunction with total knee replacement ( TKR ) .\
METHODS	50 patients were randomized to either placebo or celecoxib ( 200 mg ) preoperatively and then twice daily .\
METHODS	Total blood loss was calculated by the Hb balance method , taking the patient 's pre - and postoperative hemoglobin and blood volume into account .\
METHODS	Pain scores ( VAS ) , range of motion , and subjective outcome ( KOOS ) were monitored postoperatively and during the first year after surgery .\
RESULTS	No differences in total , hidden , or drainage blood loss were found between the groups .\
RESULTS	There were 30 % lower pain scores during the first 4 weeks after surgery and lower morphine consumption after surgery in the celecoxib group , while no effect was seen on pain , range of motion , and subjective outcome at the 1 year follow-up .\
CONCLUSIONS	Celecoxib does not increase perioperative blood loss but reduces pain during the postoperative period after TKR .\
CONCLUSIONS	It is not necessary to discontinue celecoxib before surgery .\
CONCLUSIONS	The postoperative use of celecoxib did not increase range of motion or subjective outcome 1 year after TKR .\
\
###18410769\
OBJECTIVE	Because young infants are at highest risk of pertussis complications , this study assessed whether neonatal acellular pertussis ( aP ) vaccination could provide earlier immunity .\
METHODS	Neonates ( n = 121 ) were randomly assigned ( 1:1 ) to receive either aP or hepatitis B vaccine ( HBV ) ( controls ) vaccine at birth , followed by vaccination with DTaP-HBV-IPV/Hib at 2 , 4 and 6 months .\
METHODS	Immune responses were measured .\
METHODS	Reactogenicity was assessed for 7 days after each dose .\
RESULTS	The aP birth dose was followed by few adverse events .\
RESULTS	Reactogenicity of subsequent vaccine doses did not differ between groups .\
RESULTS	Seven serious adverse events were reported from each group ; none were related to the study vaccines .\
RESULTS	At 3 months of age , vaccination with aP at birth had induced significantly higher antibody responses to the 3 pertussis antigens compared with controls .\
RESULTS	At 7 months , geometric mean/concentrations of antibodies against pertussis antigens were similar in both groups , and all subjects had reached `` seroprotective '' antibody concentrations against diphtheria , tetanus , and poliovirus types 1 , 2 , and 3 .\
RESULTS	Geometric mean/concentrations of antibodies to haemophilus influenzae type b ( Hib ) and HBV were significantly lower in the aP group .\
CONCLUSIONS	Early neonatal immunization with aP was safe , well tolerated , and resulted in earlier antibody responses , seen after the first dose of a DTaP combination vaccine .\
CONCLUSIONS	Birth dose of aP did not induce immunologic tolerance to pertussis antigens but appear to dampen responses to Hib and HBV vaccines .\
\
###15669588\
OBJECTIVE	To estimate the lifetime cost per detected potentially curable cancer and the economic impact on healthcare of repeated screening for prostate cancer in Sweden in a cohort of men aged 50-69 years .\
METHODS	All 9171 men in a geographically defined population were included : 1492 were randomized to screening in four rounds every third year and 7679 constituted a control group .\
METHODS	Digital rectal examination and prostate-specific antigen screening in different combinations were used as diagnostic measures .\
METHODS	Costs associated with administration of the screening programme , loss of patient time , diagnostic measures and management strategies were included .\
METHODS	A decision model was developed to calculate the total cost of the programme .\
RESULTS	The incremental cost per extra detected localized cancer was 168,000 SEK and per potentially curable cancer 356,000 SEK .\
RESULTS	Introducing this screening programme for prostate cancer in Sweden would incur 244 million SEK annually in additional costs for screening and treatment compared to a non-screening strategy .\
CONCLUSIONS	There is still no scientific evidence that patients will benefit from screening programmes .\
CONCLUSIONS	Prostate cancer screening would probably be perceived as cost-effective if potentially curable patients gained on average at least 1 year of survival .\
\
###25450120\
OBJECTIVE	To evaluate the effect of scapular stabilization during horizontal adduction stretching ( cross-body ) on posterior shoulder tightness ( PST ) and passive internal rotation ( IR ) .\
METHODS	Randomized controlled trial with single blinding .\
METHODS	Athletic club .\
METHODS	Asymptomatic volleyball players who are women with glenohumeral internal rotation deficit ( N = 60 ) .\
METHODS	Subjects were randomly assigned to either horizontal adduction stretching with manual scapular stabilization ( n = 30 ) or horizontal adduction stretching without stabilization ( n = 30 ) .\
METHODS	Passive stretching was performed for 3 - to 30-second holds in both groups .\
METHODS	Range of motion measurements of PST and IR were performed on the athlete 's dominant shoulder prior to and immediately after the intervention .\
RESULTS	Baseline mean angular measurements of PST and IR for all athletes involved in the study were 6214 and 4010 , respectively , with no significant difference between groups ( P = .598 and P = .734 , respectively ) .\
RESULTS	Mean PST measurements were significantly different between groups after the horizontal adduction stretch , with a mean angle of 8317 among the scapular stabilization group and 6513 among the nonstabilization group ( P < .001 ) .\
RESULTS	Measurements of IR were also significantly different between groups , with a mean angle of 5114 among the scapular stabilization group and 439 among the nonstabilization group ( P = .006 ) .\
CONCLUSIONS	Horizontal adduction stretches performed with scapular stabilization produced significantly greater improvements in IR and PST than horizontal adduction stretching without scapular stabilization .\
\
###9400450\
OBJECTIVE	We compared the efficacy and safety of alprostadil alpha-cyclodextrin and moxisylyte chlorhydrate to induce erections adequate for sexual intercourse in a prospective , randomized , parallel double-blind study in patients with erectile dysfunction .\
METHODS	A total of 156 men with erectile dysfunction due to organic , nonorganic and mixed origin was randomized into 2 parallel treatment groups receiving titrations of an individual optimum dose of alprostadil alpha-cyclodextrin or moxisylyte chlorhydrate .\
METHODS	Erectile response was measured by the buckling test .\
METHODS	A positive test was associated with axial erection rigidity that did not buckle/deform to 1.0 kg .\
METHODS	load .\
METHODS	The buckling test was repeated every 10 minutes for up to 60 minutes .\
RESULTS	A total of 56 patients ( 75 % ) in the alprostadil alpha-cyclodextrin group and 32 patients ( 40 % ) in the moxisylyte chlorhydrate group responded with at least 1 positive buckling test during the office period .\
RESULTS	Investigators assessed erections after alprostadil alpha-cyclodextrin to be adequate for sexual intercourse in 61 patients ( 81 % ) compared to 37 patients ( 46 % ) after moxisylyte chlorhydrate .\
RESULTS	All efficacy parameters in office reached statistical significance of p < 0.001 in favor of alprostadil alpha-cyclodextrin .\
RESULTS	During self-injection therapy at home 58 patients ( 85 % ) reported at least 1 rigid erection after alprostadil alpha-cyclodextrin compared to 37 patients ( 61 % ) after moxisylyte chlorhydrate .\
RESULTS	Patient and partner opinion of treatment achieved statistically significantly better scores in the alprostadil alpha-cyclodextrin group compared to the moxisylyte chlorhydrate group .\
CONCLUSIONS	Alprostadil alpha-cyclodextrin is significantly more effective than moxisylyte chlorhydrate in producing full penile rigidity in office and at home .\
CONCLUSIONS	Injection related side effects occur with the same frequency but moxisylyte results in more systemic side effects and alprostadil results in more painful and prolonged erections .\
CONCLUSIONS	Patients and partners are significantly more satisfied with alprostadil alpha-cyclodextrin .\
\
###16234833\
OBJECTIVE	Early supplementation of breastfed infants may have consequences both for the mother and the child .\
OBJECTIVE	We hypothesised that it would result in decreased maternal weight loss and in shorter durations of breastfeeding and birth intervals .\
METHODS	Controlled randomised population-based trial .\
METHODS	Six villages in the Sine area of Senegal , West Africa .\
METHODS	Healthy breastfed infants and their mothers , 68 controls and 66 supplemented infants at randomization .\
METHODS	Supplementation with high-energy , nutrient dense food from 4 to 7 months of age , twice daily under supervision of field workers .\
METHODS	Both controls and supplemented infants were free to eat other complementary foods .\
METHODS	Maternal weight was measured monthly .\
METHODS	Dates of breastfeeding cessation and of subsequent births were collected prospectively through weekly demographic surveillance , and were analysed using Cox 's regression models and ` intent-to-supplement ' approach .\
RESULTS	Mean maternal weight gain from 4 to 7 months postpartum tended to be greater in the supplemented group ( +0.25 kg/months , 95 % confidence interval ( CI ) : -0.07 , +0.57 ) .\
RESULTS	Supplemented infants were breastfed for significantly longer durations than controls ( medians : 24.9 and 23.7 months , respectively , P : 0.034 ) .\
RESULTS	Their adjusted hazard ratio ( HR ) for breastfeeding cessation was 0.59 ( 95 % CI : 0.40 , 0.89 ) .\
RESULTS	Their mothers had a lower risk of a new birth than mothers of controls ( adjusted HR : 0.57 , 95 % CI : 0.36 , 0.92 ) .\
CONCLUSIONS	Early short-term infant supplementation tended to decrease maternal postpartum weight loss , but it increased , rather than shortened , the duration of breastfeeding and birth interval .\
BACKGROUND	This study was supported by a grant from the French Ministry of Research ( Grant 92L0623 ) .\
\
###23825035\
BACKGROUND	Exercise that challenges balance can improve mobility and prevent falls in older adults .\
BACKGROUND	Yoga as a physical activity option for older adults is not well studied .\
BACKGROUND	This trial evaluated the feasibility and effect of a 12-week Iyengar yoga program on balance and mobility in older people .\
METHODS	We conducted a blinded , pilot randomized controlled trial with intention-to-treat analysis .\
METHODS	Participants were 54 community dwellers ( mean age 68 years , SD 7.1 ) not currently participating in yoga or tai chi .\
METHODS	The intervention group ( n = 27 ) participated in a 12-week , twice-weekly yoga program focused on standing postures and received a fall prevention education booklet .\
METHODS	The control group ( n = 27 ) received the education booklet only .\
METHODS	Primary outcome was standing balance component of the short physical performance battery with addition of one-legged stance time ( standing balance ) .\
METHODS	Secondary outcomes were the timed sit-to-stand test , timed 4-m walk , one-legged stand with eyes closed , and Short Falls Efficacy Scale-International .\
METHODS	Feasibility was measured by recording class attendance and adverse events .\
RESULTS	Fifty-two participants completed follow-up assessments .\
RESULTS	The intervention group significantly improved compared with control group on standing balance ( mean difference = 1.52 seconds , 95 % CI 0.10-2 .96 , p = .04 ) , sit-to-stand test ( mean difference = -3.43 seconds , 95 % CI -5.23 to -1.64 , p < .001 ) , 4-m walk ( mean difference = -0.50 seconds , 95 % CI -0.72 to -0.28 , p < .001 ) , and one-legged stand with eyes closed ( mean difference = 1.93 seconds , 95 % CI 0.40-3 .46 , p = .02 ) .\
RESULTS	Average class attendance was 20 of 24 classes ( 83 % ) .\
RESULTS	No serious adverse events occurred .\
CONCLUSIONS	This trial demonstrates the balance and mobility-related benefits and feasibility of Iyengar yoga for older people .\
CONCLUSIONS	The fall prevention effect of Iyengar yoga warrants further investigation .\
\
###15877661\
OBJECTIVE	To evaluate the effects of medetomidine and its antagonism with atipamezole in goats .\
METHODS	Prospective randomized crossover study with 1 week between treatments .\
METHODS	Six healthy 3-year-old neutered goats ( three male and three female ) weighing 39.1-90 .9 kg ( 60.0 + / - 18 kg , mean + / - SD ) .\
METHODS	Goats were given medetomidine ( 20 microg kg ( -1 ) , IV ) followed , 25 minutes later , by either atipamezole ( 100 microg kg ( -1 ) , IV ) or saline .\
METHODS	Heart and respiratory rate , rectal temperature , indirect blood pressure , and mechanical threshold were measured , and sedation and posture were scored and blood samples obtained to measure epinephrine , norepinephrine , free fatty acids , glucose , and cortisol concentrations at baseline ( immediately before medetomidine ) , 5 and 25 minutes after medetomidine administration , and at 5 , 30 , 60 , and 120 minutes after the administration of antagonist or saline .\
METHODS	Parametric and nonparametric tests were used to evaluate data ; p < 0.05 was considered significant .\
RESULTS	Medetomidine decreased body temperature , heart rate , and respiratory rate and increased mean arterial blood pressure , cortisol , and glucose .\
RESULTS	Recumbency occurred 89 + / - 50 seconds after medetomidine administration .\
RESULTS	All goats were standing 86 + / - 24 seconds after atipamezole administration whereas all goats administered saline were sedate and recumbent at 2 hours .\
RESULTS	Tolerance to compression of the withers and metacarpus increased with medetomidine .\
RESULTS	From 5 to 120 minutes after saline or atipamezole administration , there were differences in body temperature , glucose , and cortisol but none in heart rate or blood pressure .\
RESULTS	Three of the six goats receiving saline developed bloat ; five of six urinated .\
RESULTS	After atipamezole , four of six goats developed piloerection and all goats were agitated and vocalized .\
CONCLUSIONS	At the doses used , atipamezole antagonized the effects of medetomidine on recumbency , sedation , mechanical threshold , and the increase in glucose .\
CONCLUSIONS	Atipamezole increased the rate of return of cortisol toward baseline , and prevented further decline in rectal body temperature .\
CONCLUSIONS	Atipamezole may be used to antagonize some , but not all effects of medetomidine .\
\
###11698565\
BACKGROUND	Concerns have been raised that tamoxifen may be associated with depression .\
BACKGROUND	To investigate this question , we examined the psychological effects of tamoxifen treatment for breast cancer prevention on women at different levels of risk for clinical depression who were enrolled in the National Surgical Adjuvant Breast and Bowel Project 's Breast Cancer Prevention ( P-1 ) Study .\
METHODS	A total of 11 064 women were randomly assigned to receive for 5 years daily doses of 20 mg of tamoxifen or placebo in the P-1 study , a multicenter , double-blind , placebo-controlled chemoprevention trial .\
METHODS	Each woman was prospectively assessed for depression risk on the basis of medical history items collected at the baseline examination and placed in a high - , medium - , or low-risk group .\
METHODS	Every 6 months , for a total of 36 months , the participants were assessed for depressive symptoms by completing the Center for Epidemiological Studies-Depression ( CES-D ) questionnaire .\
METHODS	Scores of 16 or higher were indicative of an episode of affective distress .\
METHODS	Differences between the risk groups and treatment arms were analyzed by logistic regression .\
METHODS	All statistical tests were two-sided .\
RESULTS	Women in the higher risk depression groups were more likely to score 16 or higher on the CES-D ( percent follow-up examinations with a score of > or = 16 : high-risk group = 35.7 % , with 95 % confidence interval [ CI ] = 32.5 % to 38.9 % ; medium-risk group = 19.2 % , with 95 % CI = 18.1 % to 20.3 % ; and low-risk group = 8.7 % , with 95 % CI = 8.3 to 9.1 % ) and to have these scores more frequently and for longer periods than women in the lower risk groups .\
RESULTS	Within each depression risk group , there was no difference in the proportion of women scoring 16 or higher by treatment assignment ( tamoxifen versus placebo ) ( odds ratio = 0.98 ; 95 % CI = 0.93 to 1.02 ) .\
RESULTS	A post-hoc analysis indicated that the lack of a tamoxifen effect was not a result of differential missing data .\
CONCLUSIONS	Physicians need not be overly concerned that treatment with tamoxifen will increase the risk for or exacerbate existing depression in women .\
CONCLUSIONS	Nevertheless , physicians should continue to screen for and treat or refer potential cases of depression encountered in routine clinical practice .\
\
###25042932\
OBJECTIVE	To develop a reliable and safe laryngeal nerve conduction technique and to obtain consistent parameters as normal reference values .\
METHODS	A prospective single-arm study .\
METHODS	A nerve conduction test was performed on the contralateral normal side in 42 patients with unilateral vocal fold palsy .\
METHODS	The recording was performed in the intact thyroarytenoid muscle using a monopolar needle .\
METHODS	The electrical stimulation using a 37-mm monopolar needle was applied 3 cm below the lower margin of the cricoid cartilage , just lateral to the trachea and medial to the carotid artery , and its intensity was gradually increased until the amplitude of the electrical response reached the maximum level .\
METHODS	The latency of the evoked muscle response was acquired at the first evoked waveform deflection from the baseline .\
RESULTS	The average latency of the recurrent laryngeal nerves was 1.980.26 ms. The latencies showed normal distribution according to the quantile-quantile plot and Kolmogorov-Smirnov test ( P = .098 ) .\
RESULTS	There was no significant difference in latencies between the right and left recurrent laryngeal nerves .\
RESULTS	Anthropometric factors including height and weight did not show any correlation with the latencies .\
CONCLUSIONS	We developed a reliable and safe laryngeal nerve conduction technique and obtained normal reference values for the recurrent laryngeal nerve conduction study .\
CONCLUSIONS	This laryngeal nerve conduction study can be an additional tool for detecting recurrent laryngeal nerve injury if it is performed in combination with the conventional laryngeal electromyography .\
METHODS	4 .\
\
###20671225\
OBJECTIVE	This open , prospective , randomized trial aimed to assess the effects of statins in chronic kidney disease patients on optimized antiproteinuric treatment with combined angiotensin-converting enzyme inhibition and angiotensin receptor blockade .\
METHODS	After 1-month benazepril therapy followed by 1-month benazepril-valsartan combined therapy ( run-in ) , 186 consenting patients with residual proteinuria > 0.5 g/24 h were randomized to 6-month benazepril-valsartan therapy alone or combined with fluvastatin .\
METHODS	Between-groups changes in proteinuria ( primary outcome ) , serum lipids , and GFR were compared by ANCOVA .\
METHODS	Analyses were blinded and by intention to treat .\
RESULTS	During the run-in , proteinuria decreased more on benazepril-valsartan than on benazepril alone .\
RESULTS	Proteinuria reduction correlated with concomitant reduction in total , LDL , and HDL cholesterol , and apolipoprotein B and apolipoprotein A levels .\
RESULTS	After randomization , median proteinuria similarly decreased from 1.2 ( 0.6 to 2.2 ) to 1.1 ( 0.5 to 1.7 ) g/24 h on fluvastatin and from 1.5 ( 0.8 to 2.7 ) to 1.0 ( 0.5 to 2.4 ) g/24 h on benazapril-valsartan therapy alone .\
RESULTS	Fluvastatin further reduced total and LDL cholesterol and apolipoprotein B versus benazepril-valsartan alone , but did not affect serum triglycerides and GFR .\
RESULTS	Treatment was well tolerated .\
CONCLUSIONS	In chronic kidney disease patients with residual proteinuria despite combined angiotensin-converting enzyme inhibitor and angiotensin receptor blockade therapy , add-on fluvastatin does not affect urinary proteins , but further reduces serum lipids and is safe .\
CONCLUSIONS	Whether combined angiotensin-converting enzyme inhibitor , angiotensin receptor blockade , and statin therapy may improve cardiovascular outcomes in this high-risk population is worth investigating .\
\
###22643350\
OBJECTIVE	Entecavir ( ETV ) and tenofovir disoproxil fumarate ( TDF ) are potent antiviral agents that might have additive or synergistic antiviral activity in treatment of patients with chronic hepatitis B ( CHB ) .\
OBJECTIVE	We compared the efficacy and safety of ETV monotherapy with those of a combination of ETV and TDF .\
METHODS	We performed a randomized , open-label , multicenter , superiority study of 379 nucleos ( t ) ide-nave patients with hepatitis B e antigen ( HBeAg ) - positive ( n = 264 ) or HBeAg-negative ( n = 115 ) CHB .\
METHODS	Subjects were given ETV 0.5 mg ( n = 182 ) or a combination of ETV 0.5 mg and TDF 300 mg ( n = 197 ) for 100 weeks .\
RESULTS	At week 96 , comparable proportions of patients in each study arm achieved the primary end point of a level of hepatitis B virus ( HBV ) DNA < 50 IU/mL ( 83.2 % vs 76.4 % ; P = .088 ) .\
RESULTS	Among HBeAg-positive patients , a greater proportion given combination therapy achieved levels of HBV DNA < 50 IU/mL than those given ETV alone ( 80.4 % vs 69.8 % ; P = .046 ) .\
RESULTS	However , this difference was observed only in patients with baseline levels of HBV DNA 10 ( 8 ) IU/mL ( 79 % vs 62 % ) and not in those with baseline levels of HBV DNA < 10 ( 8 ) IU/mL ( 83 % in both arms ) .\
RESULTS	Rates of HBeAg loss and HBeAg seroconversion were comparable between groups , whereas the rate of alanine aminotransferase normalization was greater in the ETV monotherapy group .\
RESULTS	No HBV variants associated with ETV or TDF resistance were detected .\
RESULTS	Safety profiles were consistent with previous reports of ETV or TDF monotherapy .\
CONCLUSIONS	The antiviral efficacy of ETV monotherapy is comparable to that of ETV plus TDF in a mixed population of nucleos ( t ) ide-nave patients with CHB ( 70 % HBeAg positive ) .\
CONCLUSIONS	The combination therapy could provide an incremental benefit to HBeAg-positive patients with baseline levels of HBV DNA 10 ( 8 ) IU/mL .\
\
###23334615\
OBJECTIVE	The use of near-infrared light in the form of low-level laser therapy ( LLLT ) has become more popular in the treatment of a variety of conditions where increased peripheral blood flow is desired .\
OBJECTIVE	The hypothesis behind its working mechanism is its purported ability to generate nitric oxide ( NO ) in the treated area .\
OBJECTIVE	We tested the hypothesis that the efficacy of near-infrared light lies in its ability to generate NO at the treatment site .\
METHODS	We conducted a single-blind , placebo-controlled , randomized clinical trial to measure NO , by its metabolites nitrite and nitrate , in venous blood draining from tissue receiving LLLT .\
METHODS	Fifteen healthy subjects received LLLT to the forearm , and blood samples were taken immediately before treatment ; at 1 , 5 , 15 , and 30 mins ; as well as 15 mins after the treatment to check for NO content .\
RESULTS	We found a significant treatment effect ( F = 15.75 , P = 0.003 ) .\
RESULTS	A post hoc test showed that minutes 1 , 5 , and 15 were different compared with the baseline measures ( P 's < 0.05 ) .\
RESULTS	The area under the treatment curve was significantly larger than the area under the sham treatment curve ( t = 2.26 , P = 0.037 ) .\
RESULTS	A limitation of this study was that the data were collected from healthy subjects .\
CONCLUSIONS	LLLT increased NO levels in venous blood draining from the treatment site in healthy subjects .\
CONCLUSIONS	The peak increase in NO occurred 5 mins into the treatment , after which it slowly waned .\
CONCLUSIONS	Further research is necessary to assess NO increases with LLLT in patients with pathologies .\
\
###23876935\
OBJECTIVE	To determine the efficacy of autologous platelet-rich plasma ( PRP ) compared with dextrose prolotherapy ( DP ) in patients with chronic recalcitrant plantar fasciitis ( PF ) DESIGN : A single-blinded , randomized , controlled study .\
METHODS	Department of Physical Medicine and Rehabilitation of a university hospital .\
METHODS	Twenty-one patients with a clinical diagnosis of chronic PF confirmed by diagnostic ultrasound ( plantar fascia thickness > 4 mm ) were randomly assigned to the PRP group ( n = 10 ) or the DP group ( n = 11 ) .\
METHODS	Each patient received 2 injections into the plantar fascia through a peppering technique under ultrasound guidance at an interval of 2 weeks , either with 2 mL of autologous PRP or 2 mL of 15 % dextrose/lidocaine solution .\
METHODS	The outcome measures included the pain , disability , and activity limitation subscales , measured by means of the Foot Functional Index .\
METHODS	Data were collected before the first injection , at 2 weeks ( before the second injection ) , and at the 2 - and 6-month follow-ups .\
RESULTS	All patients completed the follow-ups , with the exception of 1 patient in the PRP group .\
RESULTS	The mean Foot Functional Index total and subcategory score improvements were greater in the PRP group compared with the DP group ( improvement with PRP vs DP , total : 30.4 % vs 15.1 % , pain : 29.7 % vs 17.1 % , disability : 26.6 % vs 14.5 % , activity limitation : 28.0 % vs 12.4 % ) .\
RESULTS	However , no statistically significant difference was noted at any follow-up .\
RESULTS	In the pain and disability subcategories , both groups showed significant improvements at the last re-evaluation .\
RESULTS	The PRP group also showed significant improvements in the disability and activity limitation subscales at the second re-evaluation .\
CONCLUSIONS	Each treatment seems to be effective for chronic recalcitrant PF , expanding the treatment options for patients in whom conservative care has failed .\
CONCLUSIONS	PRP treatment also may lead to a better initial improvement in function compared with DP treatment .\
\
###19621729\
OBJECTIVE	Coffee is one of the most popular beverages worldwide , however , few studies have examined the effects of coffee on the gastrointestinal system .\
OBJECTIVE	The aim of this study was to determine whether there was a correlation between coffee intake and gastric emptying using a novel non-invasive technique for measuring gastric emptying with a continuous real time 13C breath test ( BreathID system : Oridion , Israel ) .\
METHODS	Six healthy male volunteers participated in this randomized , two-way crossover study .\
METHODS	The subjects were randomly assigned to receive a test meal ( 200 kcal per 200 mL ) plus postprandial 190 mL black coffee or the test meal alone after fasting overnight .\
METHODS	A 13C-acetic acid breath test was continuously performed using the BreathID system , which monitors gastric emptying , for 4 hours after the administration of the test meal .\
METHODS	Using Oridion Research Software ( beta version ) , the time for emptying of 50 % of the labeled meals ( T 1/2 ) and the analog to the scintigraphy lag time for 10 % emptying of the labeled meal ( T lag ) were calculated .\
METHODS	The parameters between two occasions were compared using the Wilcoxon signed-rank test .\
RESULTS	After coffee intake the T 1/2 and T lag constant were significantly decreased .\
CONCLUSIONS	The decrease in the T 1/2 and T lag suggests the acceleration of gastric emptying .\
CONCLUSIONS	This study showed that postprandial coffee intake enhances gastric emptying , suggesting the potential use of coffee in clinical settings for patients with functional gastrointestinal disorders .\
\
###22886839\
BACKGROUND	The open surgical wound is exposed to cold and dry ambient air resulting in heat loss through radiation , evaporation , and convection .\
BACKGROUND	Also , general and neuraxial anesthesia decrease the patient 's core temperature .\
BACKGROUND	Despite routine preventive measures mild intraoperative hypothermia is still common and contributes to postoperative morbidity and mortality .\
BACKGROUND	We hypothesized that local insufflation of warm fully humidified CO ( 2 ) would increase both the open surgical wound and core temperature .\
METHODS	Eighty-three patients undergoing open colon surgery were equally and parallelly randomized to either standard warming measures including forced-air warming , warm fluids , and insulation of limbs and head , or to additional local wound insufflation of warm ( 37C ) humidified ( 100 % relative humidity ) CO ( 2 ) at a laminar flow ( 10 L/min ) via a gas diffuser .\
METHODS	Wound surface and core temperatures were followed with a heat-sensitive infrared camera and a tympanic thermometer .\
RESULTS	The mean wound area temperature during surgery was 31.3 C in the warm humidified CO ( 2 ) group compared with 29.6 C in the control group ( P < 0.001 , 95 % confidence interval [ CI ] , 1.2 C to 2.3 C ) .\
RESULTS	Also , the mean wound edge temperature during surgery was 30.1 C compared with 28.5 C in the control group ( P < 0.001 , 95 % CI , 0.2 C to 0.7 C ) .\
RESULTS	Mean core temperature before start of surgery was similar with 36.7 C 0.5 C in the warm humidified CO ( 2 ) group versus 36.6 C 0.5 C in the control group ( 95 % CI , 0.4 to -0.1 C ) .\
RESULTS	At end of surgery , the 2 groups differed significantly with 36.9 0.5 C in the warm humidified CO ( 2 ) group versus 36.3 0.5 C in the control group ( P < 0.001 , 95 % CI , 0.38 C to 0.82 C ) .\
RESULTS	Moreover , only 8 patients of 40 in the warm humidified CO ( 2 ) group had a core temperature < 36.5 C ( 20 % , 95 % CI , 7 to 33 % ) , whereas in the control group this was the case in 24 of 39 ( 62 % , 95 % CI , 46 % to 78 % , P = 0.001 ) patients ( difference of the percentages between the groups 42 % , 95 % CI , 22 % to 61 % , P < 0.001 ) .\
RESULTS	With a cutoff at < 36.0 C none of the patients in the warm humidified CO ( 2 ) group compared with 7 patients ( 18 % , 95 % CI , 5 % to 31 % , P = 0.005 ) in the control group was hypothermic at end of surgery ( difference of the percentages between the groups 18 % , 95 % CI , 6 % to 30 % , P = 0.005 ) .\
RESULTS	The median ( 25th/75th percentile ) operating time was 181.5 ( 147.5 / 288 ) minutes in the warm humidified CO ( 2 ) group versus 217 ( 149/288 ) minutes in the control group ( P = 0.312 ) .\
RESULTS	Clinical variables did not show any significant differences between the groups .\
CONCLUSIONS	Insufflation of warm fully humidified CO ( 2 ) in an open surgical wound cavity increases surgical wound and core temperatures and helps to maintain normothermia .\
\
###21939626\
OBJECTIVE	Animal models of hypertonic saline infusion during cardiopulmonary resuscitation ( CPR ) improve survival , as well as myocardial and cerebral perfusion during CPR .\
OBJECTIVE	We studied the effect of hypertonic saline infusion during CPR ( Guidelines 2000 ) on survival to hospital admission and hospital discharge , and neurological outcome on hospital discharge .\
METHODS	The study was performed by the EMS of Bonn , Germany , with ethical committee approval .\
METHODS	Study inclusion criteria were non-traumatic out-of-hospital cardiac arrest , aged 18-80 years , and given of adrenaline ( epinephrine ) during CPR .\
METHODS	Patients were randomly infused 2 mlkg ( -1 ) HHS ( 7.2 % NaCl with 6 % hydroxyethyl starch 200,000 / 0.5 [ HES ] ) or HES over 10 min .\
RESULTS	203 patients were randomised between May 2001 and June 2004 .\
RESULTS	After HHS infusion , plasma sodium concentration increased significantly to 16236 mmoll ( -1 ) at 10 min after infusion and decreased to near normal ( 1446 mmoll ( -1 ) ) at hospital admission .\
RESULTS	Survival to hospital admission and hospital discharge was similar in both groups ( 50/100 HHS vs. 49/103 HES for hospital admission , 23/100 HHS vs. 22/103 HES for hospital discharge ) .\
RESULTS	There was a small improvement in neurological outcome in survivors on discharge ( cerebral performance category 1 or 2 ) in the HHS group compared to the HES group ( 13/100 HHS vs. 5/100 HES , p < 0.05 , odds-ratio 2.9 , 95 % confidence interval 1.004-8 .5 ) .\
CONCLUSIONS	Hypertonic saline infusion during CPR using Guidelines 2000 did not improve survival to hospital admission or hospital discharge .\
CONCLUSIONS	There was a small improvement with hypertonic saline in the secondary endpoint of neurological outcome on discharge in survivors .\
CONCLUSIONS	Further adequately powered studies using current guidelines are needed .\
\
###23474109\
OBJECTIVE	The association of Ki-67 staining index ( Ki67-SI ) with overall survival ( OS ) , disease-specific mortality ( DSM ) , distant metastasis ( DM ) , and biochemical failure ( BF ) was examined in men with favorable - to intermediate-risk prostate cancer receiving radiation therapy ( RT ) alone or with short-term androgen deprivation ( ADT ) in Radiation Therapy Oncology Group ( RTOG ) 94-08 .\
METHODS	468 patients ( 23.6 % ) on RTOG 94-08 had sufficient tissue for Ki67-SI analysis .\
METHODS	The median follow-up time was 7.9 years .\
METHODS	Ki67-SI was determined by immunohistochemistry and quantified manually and by image analysis .\
METHODS	Correlative analysis versus clinical outcome was performed using the third quartile ( Q3 ) cutpoint .\
METHODS	A proportional hazards multivariable analysis ( MVA ) dichotomized covariates in accordance with trial stratification and randomization criteria .\
RESULTS	In MVAs adjusted for all treatment covariates , high Ki67-SI ( Q3 ) was correlated with increased DSM ( hazard ratio [ HR ] 2.48 , P = .03 ) , DM ( HR 3.5 , P = .002 ) , and BF ( HR 3.55 , P < .0001 ) .\
RESULTS	MVA revealed similar Ki67-associated hazard ratios in each separate treatment arm for DSM , DM , and BF ; these reached significance only for DM in the RT-alone arm and for BF in both arms .\
RESULTS	Ki67-SI was not a significant predictor of intraprostatic recurrence assessed by repeated biopsy 2 years after treatment .\
RESULTS	Patients with a high or low Ki67-SI seemed to experience a similar relative benefit from the addition of ADT to radiation .\
CONCLUSIONS	High Ki67-SI independently predicts for increased DSM , DM , and protocol BF in primarily intermediate-risk prostate cancer patients treated with RT with or without ADT on RTOG 94-08 but does not predict for local recurrence or for increased relative benefit from ADT .\
CONCLUSIONS	This and prior studies lend support for the use of Ki67-SI as a stratification factor in future trials .\
\
###8841871\
OBJECTIVE	This study examined the effects of allopurinol on global left ventricular function after coronary artery bypass surgery .\
METHODS	A randomized prospective partially blinded study in 52 patients undergoing elective coronary artery bypass surgery .\
METHODS	Conducted in a university-affiliated tertiary care facility .\
METHODS	Participants received 400 mg of allopurinol 18 hours and 400 mg of allopurinol orally 3 hours before surgery or no allopurinol .\
METHODS	Patients then received a standard anesthetic technique consisting of target-controlled opiate infusion and inhalation anesthesia .\
METHODS	Coronary artery bypass was performed using moderate hypothermia and oxygenated crystalloid cardioplegia .\
RESULTS	Global left ventricular function was assessed by means of left ventricular stroke work index ( LVSWI ) calculated before and after induction of anesthesia and after cardiopulmonary bypass at 15 minutes , 6 , 12 and 24 hours .\
RESULTS	There was no difference in the LVSWI before or after surgery when the two groups were compared .\
CONCLUSIONS	In this population sample , the use of preoperative allopurinol did not result in improved left ventricular stroke work after coronary artery bypass surgery .\
\
###20580423\
BACKGROUND	Results of several trials of antioxidant use during pregnancy have not shown a reduction in pre-eclampsia , but the effect in women with diabetes is unknown .\
BACKGROUND	We aimed to assess whether supplementation with vitamins C and E reduced incidence of pre-eclampsia in women with type 1 diabetes .\
METHODS	We enrolled women from 25 UK antenatal metabolic clinics in a multicentre randomised placebo-controlled trial .\
METHODS	Eligibility criteria were type 1 diabetes preceding pregnancy , presentation between 8 weeks ' and 22 weeks ' gestation , singleton pregnancy , and age 16 years or older .\
METHODS	Women were randomly allocated in a 1:1 ratio to receive 1000 mg vitamin C and 400 IU vitamin E ( alpha-tocopherol ) or matched placebo daily until delivery .\
METHODS	The randomisation sequence was stratified by centre with balanced blocks of eight patients .\
METHODS	All trial personnel and participants were masked to treatment allocation .\
METHODS	The primary endpoint was pre-eclampsia , which we defined as gestational hypertension with proteinuria .\
METHODS	Analysis was by modified intention to treat .\
METHODS	This study is registered , ISRCTN27214045 .\
RESULTS	Between April , 2003 , and June , 2008 , 762 women were randomly allocated to treatment groups ( 379 vitamin supplementation , 383 placebo ) .\
RESULTS	The primary endpoint was assessed for 375 women allocated to receive vitamins , and 374 allocated to placebo .\
RESULTS	Rates of pre-eclampsia did not differ between vitamin ( 15 % , n = 57 ) and placebo ( 19 % , 70 ) groups ( risk ratio 0.81 , 95 % CI 0.59-1 .12 ) .\
RESULTS	No adverse maternal or neonatal outcomes were reported .\
CONCLUSIONS	Supplementation with vitamins C and E did not reduce risk of pre-eclampsia in women with type 1 diabetes .\
CONCLUSIONS	However , the possibility that vitamin supplementation might be beneficial in women with a low antioxidant status at baseline needs further testing .\
BACKGROUND	The Wellcome Trust .\
\
###20068492\
OBJECTIVE	The current study examined how different training affects the kinematics and applied moments at the knee during sporting maneuvers and the potential to reduce loading of the anterior cruciate ligament ( ACL ) .\
OBJECTIVE	The training programs were 1 ) machine weights , 2 ) free weights , 3 ) balance training , and 4 ) machine weights + balance training .\
METHODS	Fifty healthy male subjects were allocated either to a control group or to one of four 12-wk training programs .\
METHODS	Subjects were tested before and after training , performing running and cutting maneuvers from which knee angle and applied knee moments were assessed .\
METHODS	Data analyzed were peak applied flexion/extension , varus/valgus , and internal/external rotation moments , as well as knee flexion angles during specific phases of stance during the maneuvers .\
RESULTS	The balance training group decreased their peak valgus and peak internal rotation moments during weight acceptance in all maneuvers .\
RESULTS	This group also lowered their flexion moments during the sidestep to 60 degrees .\
RESULTS	Free weights training induced increases in the internal rotation moment and decreases in knee flexion angle in the peak push-off phase of stance .\
RESULTS	Machine weights training elicited increases in the flexion moment and reduced peak valgus moments in weight acceptance .\
RESULTS	Machine weights + balance training resulted in no changes to the variables assessed .\
CONCLUSIONS	Balance training produced reductions in peak valgus and internal rotation moments , which could lower ACL injury risk during sporting maneuvers .\
CONCLUSIONS	Strength training tended to increase the applied knee loading known to place strain on the ACL , with the free weights group also decreasing the amount of knee flexion .\
CONCLUSIONS	It is recommended that balance training be implemented because it may reduce the risk of ACL injury .\
\
###23810267\
BACKGROUND	Achievement and maintenance of good asthma control is a major objective in asthma management .\
BACKGROUND	However , asthma control in many patients is suboptimal , due to improper use of asthma medications and non-adherence .\
BACKGROUND	The aim of this study was to evaluate the effect of a pharmacist intervention on asthma control in adult patients .\
METHODS	A 6-month cluster randomized controlled trial was undertaken with allocation of community pharmacies to intervention or control group .\
METHODS	Adult asthma patients in the intervention group received a protocol-based intervention addressing individual needs related to asthma control , inhaler technique and medication adherence .\
METHODS	Patients in the control group received usual care .\
METHODS	Main variables were measured at baseline , 3 and 6 months .\
RESULTS	336 patients completed the study , 150 in the control group and 186 in the intervention group .\
RESULTS	The intervention resulted in enhanced asthma control : Patients receiving the intervention had an Odds ratio of 3.06 ( 95 % CI :1.63 -5.73 ; p < 0.001 ) of having controlled asthma six months later .\
RESULTS	In the intervention group mean ACQ scores significantly improved [ 0.66 points ( SD : 0.78 ) ; p < 0.001 ] and the number of controlled asthma patients increased by 30.1 % ( p < 0.001 ) after 6 months .\
RESULTS	The intervention also resulted in improved medication adherence ( by 40.3 % , p < 0.001 ) and inhaler technique ( by 56.2 % , p < 0.001 ) .\
RESULTS	No significant changes for any of these variables were observed in the control group .\
CONCLUSIONS	The AFasma study focused on the important outcomes of asthma management , and showed that through the designed intervention , community pharmacists can increase controlled asthma patients compared to usual care .\
CONCLUSIONS	Trial registration NCT01085474 .\
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###15303109\
BACKGROUND	We have previously reported that a fat-reduced high-protein diet had more favourable effects on body weight loss over 6 months than a medium-protein diet .\
OBJECTIVE	To extend this observation by a further 6-12 months less stringent intervention and a 24 months follow-up .\
METHODS	A randomised 6 months strictly controlled dietary intervention followed by 6-12 months dietary counselling period , and a subsequent 24 months follow-up , comparing an ad libitum , fat-reduced diet ( 30 % of energy ) either high in protein ( 25 % of energy , HP ) or medium in protein ( 12 % of energy , MP ) .\
METHODS	A total of 50 overweight and obese subjects ( age : 19-55 y ; BMI : 26-34 kg/m ( 2 ) ) .\
METHODS	Change in body weight , body composition and blood parameters .\
RESULTS	After 6 months , the HP group ( n = 23 ) achieved a greater weight loss than the MP group ( n = 23 ) ( 9.4 vs 5.9 kg ) ( P < 0.01 ) .\
RESULTS	After 12 months , 8 % had dropped out in the HP vs 28 % in the MP group ( P < 0.07 ) .\
RESULTS	After 12 months , the weight loss was not significantly greater among the subjects in the HP group ( 6.2 and 4.3 kg ) , but they had a 10 % greater reduction in intra-abdominal adipose tissue and more in the HP group ( 17 % ) lost > 10 kg than in the MP ( P < 0.09 ) .\
RESULTS	At 24 months , both groups tended to maintain their 12 months weight loss , but more than 50 % were lost to follow-up .\
CONCLUSIONS	A fat-reduced diet high in protein seems to enhance weight loss and provide a better long-term maintenance of reduced intra-abdominal fat stores .\
\
###18301949\
OBJECTIVE	A randomized , controlled trial comparing hand-assisted laparoscopic restorative proctocolectomy with open surgery did not show an advantage for the laparoscopic approach .\
OBJECTIVE	The trial was criticized because hand-assisted laparoscopic restorative proctocolectomy was not considered a true laparoscopic proctocolectomy .\
OBJECTIVE	The objective of the present study was to assess whether total laparoscopic restorative proctocolectomy has advantages over hand-assisted laparoscopic restorative proctocolectomy with respect to early recovery .\
METHODS	Thirty-five patients underwent total laparoscopic restorative proctocolectomy and were compared to 60 patients from a previously conducted randomized , controlled trial comparing hand-assisted laparoscopic restorative proctocolectomy and open restorative proctocolectomy .\
METHODS	End points included operating time , conversion rate , reoperation rate , hospital stay , morbidity , quality of life , and costs .\
METHODS	The Medical Outcomes Study Short Form 36 and the Gastrointestinal Quality of Life Index were used to evaluate general and bowel-related quality of life .\
RESULTS	Groups were comparable for patient characteristics , such as sex , body mass index , preoperative disease duration , and age .\
RESULTS	There were neither conversions nor intraoperative complications .\
RESULTS	Median operating time was longer in the total laparoscopic compared with the hand-assisted laparoscopic group ( 298 vs. 214 minutes ; P < 0.001 ) .\
RESULTS	Morbidity and reoperation rates in the total laparoscopic , hand-assisted laparoscopic , and open groups were comparable ( 29 vs. 20 vs. 23 percent and 17 vs. 10 vs. 13 percent , respectively ) .\
RESULTS	Median hospital-stay was 9 days in the total laparoscopic group compared with 10 days in the hand-assisted laparoscopic group and 11 days in the open group ( P = not significant ) .\
RESULTS	There were no differences in quality of life and total costs .\
CONCLUSIONS	There were no significant short-term benefits for total laparoscopic compared with hand-assisted laparoscopic restorative proctocolectomy with respect to early morbidity , operating time , quality of life , costs , and hospital stay .\
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###23853555\
OBJECTIVE	The present study investigated whether bright light exposure during the first half of the evening/night shift combined with light attenuation in the morning is effective in improving sleep problems in nurses undertaking rotating shift work who suffer from clinical insomnia .\
METHODS	This was a prospective , randomized control study .\
METHODS	The Insomnia Severity Index ( ISI ) and the Hospital Anxiety Depression Scale ( HADS ) were used to evaluate insomnia and anxiety/depression severity , respectively .\
METHODS	Female hospital nurses on rotating shifts during the evening or night shift with an ISI score > 14 were enrolled .\
METHODS	Subjects in the treatment group ( n = 46 ) were exposed to bright light at 7,000-10 ,000 lux for 30 minutes .\
METHODS	Exposure was continued for at least 10 days during 2 weeks , and the subjects avoided daytime outdoor sun exposure after work by wearing dark sunglasses .\
METHODS	Subjects in the control group ( n = 46 ) were not exposed to bright light , but also wore sunglasses after work .\
METHODS	Statistical analyses were performed to examine group differences and differences across treatments .\
RESULTS	After treatment , the treatment group showed significant improvements in the ISI score and the HADS total and subscale scores as compared with pre-treatment .\
RESULTS	The ISI , HADS , and subscales of the HADS scores were significantly improved across treatments in the treatment group as compared with the control group .\
CONCLUSIONS	The design of this study is easy to put into practice in the real world .\
CONCLUSIONS	This is the first study to document that a higher intensity and briefer duration of bright light exposure during the first half of the evening/night shift with a daytime darkness procedure performed in rotating shift work female nurses suffering from clinical insomnia could improve their insomnia , anxiety , and depression severity .\
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###24874781\
BACKGROUND	Limited time and lack of knowledge are barriers to physical activity counseling in primary care .\
BACKGROUND	The objective of this study was to examine the effectiveness of a clinician-targeted intervention that used the 5As ( Ask , Advise , Agree , Assist , Arrange ) approach to physical activity counseling in a medically underserved patient population .\
METHODS	Family medicine clinicians at 2 community health centers were randomized to Group 1 or Group 2 intervention .\
METHODS	Both clinician groups participated in 4 training sessions on the 5As for physical activity counseling ; Group 2 training took place 8 months after Group 1 training .\
METHODS	Both groups were trained to refer patients to a community exercise program .\
METHODS	We used a pre-post analysis to evaluate the effectiveness of the intervention on clinician use of 5As .\
METHODS	Eligible patients ( n = 319 ) rated their clinicians ' counseling skills by using a modified Physical Activity Exit Interview ( PAEI ) survey .\
METHODS	Clinicians ( n = 10 ) self-assessed their use of the 5As through a survey and interviews .\
RESULTS	Both patient and clinician groups had similar sociodemographic characteristics .\
RESULTS	The PAEI score for both groups combined increased from 6.9 to 8.6 ( on a scale of 0-15 ) from baseline to immediately postintervention ( P = .01 ) and was 8.2 ( P = .09 ) at 6-month follow-up ; most of the improvement in PAEI score was due to increased use of 5As skills by Group 2 clinicians .\
RESULTS	Group 1 reported difficulty with problem solving , whereas Group 2 reported ease of referral to the community exercise program .\
CONCLUSIONS	A clinician training intervention showed mixed results for 5As physical activity counseling .\
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###23237314\
BACKGROUND	There is a large treatment gap in alcohol dependence , and current treatments are only moderately effective in preventing relapse .\
BACKGROUND	New treatment modalities , allowing for reduction of alcohol consumption as a treatment goal are needed .\
BACKGROUND	This study evaluated the efficacy of as-needed use of the opioid system modulator nalmefene in reducing alcohol consumption in patients with alcohol dependence .\
METHODS	Six hundred and four patients ( placebo = 298 ; nalmefene = 306 ) ,18 years of age , with a diagnosis of alcohol dependence ,6 heavy drinking days , and average alcohol consumptionWorld Health Organization medium drinking risk level in the 4 weeks preceding screening , were randomized ( 1:1 ) to 24 weeks of as-needed placebo or nalmefene 18 mg .\
RESULTS	Patients taking placebo ( n = 289 ) and patients taking nalmefene ( n = 290 ) were included in the efficacy analyses .\
RESULTS	At Month 6 , there was a significant effect of nalmefene compared with placebo in reducing the number of heavy drinking days ( -2.3 days [ 95 % confidence interval : -3.8 to -.8 ] ; p = .0021 ) and total alcohol consumption ( -11.0 g/day [ 95 % confidence interval : -16.8 to-5 .1 ] ; p = .0003 ) .\
RESULTS	Improvements in Clinical Global Impression and liver enzymes were larger in the nalmefene group compared with placebo at Week 24 .\
RESULTS	Adverse events ( most mild or moderate ) and dropouts due to adverse events were more common with nalmefene than placebo .\
RESULTS	The number of patients with serious adverse events was similar in the two groups .\
CONCLUSIONS	Nalmefene provides clinical benefit , constitutes a potential new pharmacological treatment paradigm in terms of the treatment goal and dosing regimen , and provides a method to address the unmet medical need in patients with alcohol dependence that need to reduce their alcohol consumption .\
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###12165576\
OBJECTIVE	SLI381 ( Adderall XR ) is a 2-component extended-release capsule formulation of Adderall designed to produce a therapeutic effect that lasts throughout the day with 1 morning dose .\
OBJECTIVE	The primary objective of this study was to assess the efficacy and safety of SLI381 compared with placebo in the treatment of attention-deficit/hyperactivity disorder ( ADHD ) in children in a naturalistic school and home setting .\
OBJECTIVE	A secondary objective was to assess the diurnal variation in responses based on morning and afternoon assessments .\
METHODS	A multicenter , randomized , double-blind , parallel-group , placebo-controlled trial was conducted at 47 sites .\
METHODS	After a 1-week washout of any previous stimulant medication , patients were randomized to receive single-daily morning doses of placebo or SLI381 10 mg , 20 mg , or 30 mg for 3 weeks .\
METHODS	Participants aged 6 to 12 years inclusive who satisfied Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria diagnosis of ADHD were included .\
METHODS	The primary efficacy parameter was the Conners Global Index Scale for Teachers .\
METHODS	Secondary efficacy parameters included the Conners Global Index Scale for Parents , the Clinical Global Impressions Scale for improvement , and the Parent Global Assessment for improvement .\
METHODS	Safety was assessed by recording adverse events , laboratory tests , and vital signs at each visit during the study .\
METHODS	Physical examinations and electrocardiograms were performed at the screening and the end of the study .\
RESULTS	Five hundred eighty-four children were randomized , 563 were included in the intent-to-treat population , and 509 completed the entire study .\
RESULTS	Intention-to-treat analysis of Conners Global Index Scale for Teachers and Conners Global Index Scale for Parents scores revealed significant improvement in morning , afternoon , and late afternoon behavior for all active treatment groups versus placebo .\
RESULTS	All active treatment groups showed significant dose-related improvement in behavior from baseline .\
RESULTS	Both the Clinical Global Impressions Scale for improvement and Parent Global Assessment for improvement showed all doses of SLI381 to be superior to placebo at treatment end and both confirmed the dose-response relationship between improvement and the SLI381 dose .\
RESULTS	The incidence of spontaneously reported adverse events was low and similar for active treatments and placebo .\
CONCLUSIONS	SLI381 produced consistent , dose-related improvements on all measures of efficacy .\
CONCLUSIONS	The extended-release nature of the SLI381 formulation was shown by continued , significant improvement in afternoon assessments by teachers and afternoon and late afternoon assessments by parents .\
CONCLUSIONS	The time course and therapeutic effects of SLI381 suggests that this medication is an efficacious once-daily treatment for children with ADHD .\
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###15080351\
OBJECTIVE	The purpose of this pilot project was to determine the effect of a 10 % povidone-iodine solution on plaque Streptococcus mutans and on incidence of new caries in young children following dental rehabilitation under general anesthesia .\
METHODS	Twenty-five children ages 2 to 7 years , scheduled for dental treatment under general anesthesia , were enrolled .\
METHODS	Children in the experimental group ( N = 13 ) had povidone-iodine applied 3 times at 2-month intervals .\
METHODS	Control children ( N = 12 ) had no treatment .\
METHODS	Plaque samples were taken from all children at baseline , 6 months and cultured for total bacteria and S mutans .\
METHODS	Dental examinations were conducted at baseline , 6 months , and 1 year .\
RESULTS	Experimental and control children had similar dietary habits , caries experience , and S mutans levels at baseline .\
RESULTS	All children 's S mutans counts decreased significantly at 6 months ( P = .003 ) .\
RESULTS	The difference between the 2 groups was not significant ( P = .58 ) .\
RESULTS	At 1 year , 5 of 8 children in the control group had new caries compared to 2 of 11 children in the experimental group ( P = .06 ) .\
RESULTS	Povidone-iodine was well accepted by participating families .\
CONCLUSIONS	Extensive one-time restorative dental treatment resulted in a significant suppression S mutans levels at 6 months .\
CONCLUSIONS	Further exploration of the role of povidone-iodine in caries management is indicated .\
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###16291984\
BACKGROUND	Sildenafil inhibits phosphodiesterase type 5 , an enzyme that metabolizes cyclic guanosine monophosphate , thereby enhancing the cyclic guanosine monophosphate-mediated relaxation and growth inhibition of vascular smooth-muscle cells , including those in the lung .\
METHODS	In this double-blind , placebo-controlled study , we randomly assigned 278 patients with symptomatic pulmonary arterial hypertension ( either idiopathic or associated with connective-tissue disease or with repaired congenital systemic-to-pulmonary shunts ) to placebo or sildenafil ( 20 , 40 , or 80 mg ) orally three times daily for 12 weeks .\
METHODS	The primary end point was the change from baseline to week 12 in the distance walked in six minutes .\
METHODS	The change in mean pulmonary-artery pressure and World Health Organization ( WHO ) functional class and the incidence of clinical worsening were also assessed , but the study was not powered to assess mortality .\
METHODS	Patients completing the 12-week randomized study could enter a long-term extension study .\
RESULTS	The distance walked in six minutes increased from baseline in all sildenafil groups ; the mean placebo-corrected treatment effects were 45 m ( +13.0 percent ) , 46 m ( +13.3 percent ) , and 50 m ( +14.7 percent ) for 20 , 40 , and 80 mg of sildenafil , respectively ( P < 0.001 for all comparisons ) .\
RESULTS	All sildenafil doses reduced the mean pulmonary-artery pressure ( P = 0.04 , P = 0.01 , and P < 0.001 , respectively ) , improved the WHO functional class ( P = 0.003 , P < 0.001 , and P < 0.001 , respectively ) , and were associated with side effects such as flushing , dyspepsia , and diarrhea .\
RESULTS	The incidence of clinical worsening did not differ significantly between the patients treated with sildenafil and those treated with placebo .\
RESULTS	Among the 222 patients completing one year of treatment with sildenafil monotherapy , the improvement from baseline at one year in the distance walked in six minutes was 51 m.\
CONCLUSIONS	Sildenafil improves exercise capacity , WHO functional class , and hemodynamics in patients with symptomatic pulmonary arterial hypertension .\
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###17588394\
BACKGROUND	No standard protocol of warfarin cessation and bridging for cardiac surgery exists .\
BACKGROUND	This study examined a single institution 's protocol with respect to timing of cessation and low molecular weight heparin bridging .\
BACKGROUND	The recovery of vitamin K-dependent factors and the effects of cardiopulmonary bypass on coagulation factors were explored .\
BACKGROUND	Administration of preoperative oral vitamin K was investigated in a randomized , placebo-controlled trial .\
BACKGROUND	A post hoc analysis examined residual anti-Xa activity of enoxaparin bridging .\
METHODS	Forty patients on warfarin undergoing cardiopulmonary bypass were randomized to receive 5 mg of oral vitamin K or placebo 6 days before surgery .\
METHODS	Blood samples were acquired at six times and assayed for prothrombin time , anti-Xa activity , and functional levels of factors II , V , VII , and IX and of protein C. Measures of bleeding and transfusion were also collected .\
RESULTS	No difference in bleeding or transfusion was observed between the treatment groups .\
RESULTS	Appropriate recovery of coagulation factors was observed with warfarin cessation irrespective of treatment group .\
RESULTS	The coagulation factors decreased by an average of 0.36 units/mL during the period of surgery .\
RESULTS	Enoxaparin 1 mg/kg until the evening before surgery resulted in 70 % of patients entering the operating room with therapeutic anti-Xa activity ( 0.6 + / - 0.3 units/mL ) .\
CONCLUSIONS	The cessation of warfarin 6 days preoperatively is sufficient for functional recovery of vitamin K-dependent factors , which undergo significant changes during the operative course .\
CONCLUSIONS	A 5-mg dose of vitamin K with warfarin discontinuation did not enhance recovery of vitamin K-dependent factors and is unnecessary .\
CONCLUSIONS	With the observation that enoxaparin up until the night before surgery resulted in high residual anti-Xa levels in the operating room , our center now administers the last dose of enoxaparin 24 hours before surgery .\
\
###21214899\
BACKGROUND	Airway Bypass is a catheter-based , bronchoscopic procedure in which new passageways are created that bypass the collapsed airways , enabling trapped air to exit the lungs .\
BACKGROUND	The Exhale Airway Stents for Emphysema ( EASE ) Trial was designed to investigate whether Exhale Drug-Eluting Stents , placed in new passageways in the lungs , can improve pulmonary function and reduce breathlessness in severely hyperinflated , homogeneous emphysema patients ( NCT00391612 ) .\
METHODS	The multi-center , randomized , double-blind , sham-controlled trial design was posted on http://www.clinicaltrials.gov in October 2006 .\
METHODS	Because Bayesian statistics are used for the analysis , the proposed enrollment ranged from 225 up to 450 subjects at up to 45 institutions .\
METHODS	Inclusion criteria are : high resolution CT scan with evidence of homogeneous emphysema , post-bronchodilator pulmonary function tests showing : a ratio of FEV1/FVC < 70 % , FEV1 50 % of predicted or FEV1 < 1 liter , RV/TLC 0.65 at screening , marked dyspnea score 2 on the modified Medical Research Council scale of 0-4 , a smoking history of at least 20 pack years and stopped smoking for at least 8 weeks prior to enrollment .\
METHODS	Following 16 to 20 supervised pulmonary rehabilitation sessions , subjects were randomized 2:1 to receive either a treatment ( Exhale Drug-Eluting Stent ) or a sham bronchoscopy .\
METHODS	A responder analysis will evaluate the co-primary endpoints of an FVC improvement 12 % of the patient baseline value and modified Medical Research Council dyspnea scale improvement ( reduction ) 1 point at the 6-month follow-up visit .\
CONCLUSIONS	If through the EASE Trial , Airway Bypass is shown to improve pulmonary function and reduce dyspnea while demonstrating an acceptable safety profile , then homogeneous patients will have a minimally invasive treatment option with meaningful clinical benefit .\
BACKGROUND	ClinicalTrials.gov : NCT00391612 .\
\
###15455739\
BACKGROUND	A new battery-powered toothbrush with a fundamentally different design than other powered toothbrushes has recently been introduced .\
BACKGROUND	The new toothbrush has a powered oscillating round head and a second powered head that translates back and forth .\
BACKGROUND	This study compared the plaque removal efficacy of a manual toothbrush to this new powered toothbrush .\
METHODS	This randomized , controlled , examiner-masked , four-period cross-over study examined plaque removal with the two toothbrushes following a single use in 40 subjects .\
METHODS	Plaque was scored before brushing and after 1 and 3 minutes of brushing using the Turesky modification of the Quigley-Hein index .\
RESULTS	Baseline plaque scores were 2.98 prior to using the powered toothbrush and 2.99 prior to using the manual toothbrush .\
RESULTS	The powered toothbrush delivered a covariance-adjusted mean plaque score change from baseline of 0.61 after 1 minute of brushing and 0.93 after 3 minutes of brushing .\
RESULTS	The adjusted mean changes for the manual toothbrush were 0.43 and 0.62 , respectively .\
RESULTS	The differences between treatment groups were statistically significant ( P < 0.001 ) after both 1 and 3 minutes of brushing .\
RESULTS	The powered toothbrush had , on average , 42.1 % and 49.6 % greater plaque removal scores after 1 minute and 3 minutes of brushing , respectively .\
RESULTS	Both toothbrushes had statistically significantly greater plaque removal scores after 3 minutes than after 1 minute of brushing ( P < 0.001 ) .\
RESULTS	Plaque removal scores for each toothbrush after 3 minutes of brushing were about 50 % higher than the scores after 1 minute of brushing .\
CONCLUSIONS	The powered toothbrush delivered statistically significantly superior plaque removal after both 1 and 3 minutes of brushing compared to the manual toothbrush .\
CONCLUSIONS	Both toothbrushes showed statistically significantly greater plaque removal following 3 minutes of brushing than following 1 minute of brushing , and the difference between the toothbrushes was greater following 3 minutes of brushing than following 1 minute of brushing .\
\
###23791771\
OBJECTIVE	The aim of this study was to evaluate the efficacy of three different interventions ( non-desensitising toothpaste , desensitising toothpaste and professionally applied dentine bonding agent ) in reducing dentinal hypersensitivity over a 2-week , 3-month and 6-month-period in a dental practice setting .\
METHODS	This was a randomised controlled , single-blind ; parallel-group trial conducted in general dental practice by a single general dental practitioner .\
METHODS	Seventy-five subjects were randomly allocated to three groups ; non-desensitising toothpaste ( NDT ) , desensitising toothpaste ( DT ) and professionally applied desensitising agent ( DA ) .\
METHODS	Dentinal hypersensitivity was measured using a Visual Analogue Scale ( VAS ) to record the response from a standardised short blast of air from a triple syringe .\
METHODS	Dentinal hypersensitivity was recorded at baseline , two weeks , three months and six months for all groups .\
RESULTS	Dentinal hypersensitivity reduced significantly ( p < 0.0001 ) in both groups DT and DA , in addition the reduction in sensitivity was sustained and continued to improve over a 6-month-period .\
RESULTS	The greatest reduction in dentinal hypersensitivity was recorded in group DA .\
CONCLUSIONS	The results from this study suggest that application of dentine bonding agents , to teeth diagnosed with dentine hypersensitivity provides the greatest improvement in dentine hypersensitivity at 2 weeks and 6 months .\
CONCLUSIONS	This reduction in dentine hypersensitivity is greater than that achieved by the desensitising toothpaste tested and a non-desensitising toothpaste .\
\
###15175628\
OBJECTIVE	To test a system of arranging the first newborn follow-up appointments made from the hospital prior to discharge .\
METHODS	Prospective randomized study of 328 term healthy newborns divided into control and intervention groups .\
METHODS	As there were multiple practices , we checked for clustering in the two groups and then compared them for patient compliance with the first newborn appointment .\
METHODS	We also compared the control and intervention groups for compliance with regard to insurance status .\
RESULTS	There was difference between the control and intervention group in timeliness for the first appointment ( control , 84.9 % , intervention group , 94.2 % , p = 0.0062 ) .\
RESULTS	There was also improvement in privately insured patients ( control 89.1 % , intervention 96.5 % , p = 0.0263 ) , as well as in Medicaid + noninsured patients ( control 64.7 % , intervention 90.2 % , p = 0.0245 ) .\
CONCLUSIONS	We conclude that arranging for follow-up appointments from the hospital is a worthwhile inexpensive intervention that could significantly improve patient compliance with the first newborn visit .\
\
###15056426\
OBJECTIVE	To analyze the value of early resting myocardial perfusion gated-SPECT in patients with chest pain and non-diagnostic ECG in the emergency department .\
METHODS	222 patients ( 49 % women , mean age 61 [ 13 ] years ) with atypical chest pain and with non-diagnostic ECG were randomized into two groups .\
METHODS	Group A comprised 111 patients in whom early resting myocardial perfusion gated-SPECT ( < 6 hours since the end of chest pain ) was performed and CK-MB mass and troponin I were determined at 0 , 4 and 8 hours .\
METHODS	Group B comprised 111 patients with conventional management in the emergency department without gated-SPECT .\
RESULTS	Myocardial perfusion gated-SPECT was positive in all 8 patients with increased levels of CK-MB mass and troponin I.\
RESULTS	This corresponded to a sensitivity and a negative predictive value of 100 % for the diagnosis of AMI .\
RESULTS	Specificity was 84 % and positive predictive value was 33 % when doubtful results were considered as negative .\
RESULTS	The number of patients admitted ( 18.4 % vs 32.7 % , P < .027 ) and length of stay ( 13 [ 6 ] hours vs 15.9 [ 8.6 ] hours , P < .009 ) in the emergency department were lower in group A.\
CONCLUSIONS	In patients with atypical chest pain and non-diagnostic ECG in the emergency department , early resting gated-SPECT was highly sensitive and showed good negative predictive value for the diagnosis of AMI , but positive predictive value was low .\
CONCLUSIONS	This technique may reduce the number of hospitalized patients and length of stay in the emergency department .\
\
###19282098\
BACKGROUND	Even in castration-resistant prostate cancer ( CRPC ) , the androgen pathway remains biologically relevant .\
BACKGROUND	In preclinical models , androgen therapy for CRPC leads to growth arrest , apoptosis , and tumor shrinkage .\
OBJECTIVE	This study sought to determine the toxicity and feasibility of a testosterone therapy in early CRPC .\
METHODS	Prostate cancer patients with progressive disease following androgen ablation , antiandrogen therapy , and withdrawal and no to minimal metastatic disease who were followed at the University of Chicago were randomized to treatment with three doses of transdermal testosterone .\
METHODS	Patients were treated with transdermal testosterone at 2.5 , 5.0 , or 7.5 mg/day .\
METHODS	Toxicity , prostate-specific antigen ( PSA ) , imaging , quality of life ( QoL ) , and strength were monitored .\
METHODS	Treatment was discontinued for significant toxicity , clinical progression , or a 3-fold increase in PSA .\
CONCLUSIONS	Fifteen men with a median age of 73 yr ( range : 62-92 ) and a median PSA of 11.1 ng/ml ( range : 5.2-63 .6 ) were treated .\
CONCLUSIONS	Testosterone increased from castrate to median concentrations of 305 ng/dl , 308 ng/dl , and 297 ng/dl for dosages of 2.5 mg/day ( n = 4 ) , 5.0 mg/day ( n = 5 ) , and 7.5 mg/day ( n = 5 ) , respectively .\
CONCLUSIONS	One patient was taken off of the study at 53 wk due to grade 4 cardiac toxicity .\
CONCLUSIONS	There were no other grade 3 or 4 toxicities related to the study medication , and the grade 2 toxicities were minimal .\
CONCLUSIONS	Only one patient experienced symptomatic progression , and three ( 20 % ) patients demonstrated a decrease in PSA ( largest was 43 % ) .\
CONCLUSIONS	Median time to progression was 9 wk ( range : 2-96 ) , with no detectable difference in the three dose cohorts .\
CONCLUSIONS	There was no significant improvement in QoL , and there was a borderline statistically significant improvement in hand-grip strength with treatment .\
CONCLUSIONS	The study was limited by sample size , single arm , and variability of baseline patient characteristics .\
CONCLUSIONS	Testosterone is a feasible and reasonably well-tolerated therapy for men with early CRPC .\
CONCLUSIONS	A larger , randomized trial is under way to further characterize efficacy and impact on QoL measures .\
\
###19190927\
OBJECTIVE	To evaluate the beneficial effects of Implanon on pelvic pain in women with pelvic congestion syndrome ( PCS ) .\
OBJECTIVE	The efficacy of pain control , amount and frequency of menstrual loss , degree of patient 's satisfaction and objective pelvic venography scores were investigated .\
METHODS	In a prospective open-labelled study , 25 consecutive women complaining of chronic pelvic pain were recruited .\
METHODS	Pretreatment objective peruterine venography and diagnostic laparoscopy of pure PCS together with subjective pelvic pain scores , prefilled questionnaire of Hospital Anxiety and Depression Scale ( HADS ) , visual analogue scale ( VAS ) , verbal rating scale ( VRS ) and quantified menstrual loss using the pictorial blood loss chart were documented in all cases .\
METHODS	After identification , 23 subjects with pure PCS were randomly assigned to have either Implanon inserted subcutaneously ( 12 cases ) or no treatment ( 11 cases ) .\
METHODS	Patients were followed up at 1 , 3 , 6 , 9 and 12 months .\
METHODS	A symptom diary for side effects , VAS , VRS and menstrual scores were used to assess the subjective response to treatment .\
METHODS	At the end of the study , all patients underwent repeat venography to assess the long-term objective response .\
METHODS	After 12 months , subjects having Implanon inserted were requested to rate their overall degree of satisfaction with therapy .\
RESULTS	All 25 women recruited in the study completed follow-up .\
RESULTS	Two cases were excluded from the study and referred to the psychiatry department after a negative evaluation for disease and HADS scores relevant for depression .\
RESULTS	An improvement in symptoms was observed throughout the 12 months amongst the Implanon group versus no treatment .\
RESULTS	The greatest changes in pain assessed using either the VAS or VRS were between the pretreatment scores and those after 6 months ( 7.7 + / - 1.3 vs. 4.6 + / - 3.0 for VAS , P < 0.001 ; and 25 + / - 13.8 vs. 19 + / - 18.9 for VRS , P < 0.002 ) .\
RESULTS	The monthly quantified blood loss fell from 204 ( 196 ) pretreatment to 90 ( 157 ) at 6 months ( P < 0.001 ) and then to 64 ( 32 ) at 9 months ( P < 0.002 ) .\
RESULTS	Objective repeat venography score was reduced significantly at 1 year after treatment compared with the baseline evaluation as well as with the control group ( 4.5 + / - 1.2 vs. 8.6 + / - 0.5 ; P = 0.001 and 4.2 + / - 0.9 vs. 8.5 + / - 0.6 ; P = 0.0002 , respectively ) .\
RESULTS	At final satisfaction assessment , 2 ( 17 % ) women were very satisfied 8 ( 66 % ) were satisfied , and 2 ( 17 % ) were uncertain .\
RESULTS	The implant was retained by all women at the end of the study .\
CONCLUSIONS	Implanon seems to be an effective hormonal alternative for long-term treatment of properly selected patients with pure PCS-related pelvic pain .\
\
###19895679\
BACKGROUND	About 80 % of all stroke survivors have an upper limb paresis immediately after stroke , only about a third of whom ( 30 to 40 % ) regain some dexterity within six months following conventional treatment programs .\
BACKGROUND	Of late , however , two recently developed interventions -- constraint-induced movement therapy ( CIMT ) and bilateral arm training with rhythmic auditory cueing ( BATRAC ) -- have shown promising results in the treatment of upper limb paresis in chronic stroke patients .\
BACKGROUND	The ULTRA-stroke ( acronym for Upper Limb TRaining After stroke ) program was conceived to assess the effectiveness of these interventions in subacute stroke patients and to examine how the observed changes in sensori-motor functioning relate to changes in stroke recovery mechanisms associated with peripheral stiffness , interlimb interactions , and cortical inter - and intrahemispheric networks .\
BACKGROUND	The present paper describes the design of this single-blinded randomized clinical trial ( RCT ) , which has recently started and will take several years to complete .\
METHODS	Sixty patients with a first ever stroke will be recruited .\
METHODS	Patients will be stratified in terms of their remaining motor ability at the distal part of the arm ( i.e. , wrist and finger movements ) and randomized over three intervention groups receiving modified CIMT , modified BATRAC , or an equally intensive ( i.e. , dose-matched ) conventional treatment program for 6 weeks .\
METHODS	Primary outcome variable is the score on the Action Research Arm test ( ARAT ) , which will be assessed before , directly after , and 6 weeks after the intervention .\
METHODS	During those test sessions all patients will also undergo measurements aimed at investigating the associated recovery mechanisms using haptic robots and magneto-encephalography ( MEG ) .\
CONCLUSIONS	ULTRA-stroke is a 3-year translational research program which aims ( 1 ) to assess the relative effectiveness of the three interventions , on a group level but also as a function of patient characteristics , and ( 2 ) to delineate the functional and neurophysiological changes that are induced by those interventions.The outcome on the ARAT together with information about changes in the associated mechanisms will provide a better understanding of how specific therapies influence neurobiological changes , and which post-stroke conditions lend themselves to specific treatments .\
BACKGROUND	The ULTRA-stroke program is registered at the Netherlands Trial Register ( NTR , http://www.trialregister.nl , number NTR1665 ) .\
\
###22677076\
OBJECTIVE	To determine whether targeted pharmacological improvement of insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory cardiovascular disease ( CVD ) biomarkers in individuals with insulin resistance .\
METHODS	Study 1 was a cross-sectional study of Asian Indians with and without diabetes mellitus and Northern European Americans without diabetes ( n = 14 each ) conducted between December 11 , 2003 , and July 14 , 2006 .\
METHODS	Study 2 was a secondary analysis of a double-blind randomized controlled study conducted between August 19 , 2005 , and August 24 , 2010 , that included 25 individuals with untreated diabetes or impaired fasting glucose who were randomized to receive placebo ( n = 13 ) or a combination of metformin , 1000 mg twice daily , and pioglitazone , 45 mg daily ( n = 12 ) , for 3 months .\
METHODS	In both studies , measurements of insulin sensitivity ( euglycemic-hyperinsulinemic clamp ) and plasma inflammatory and thrombotic factor concentrations were obtained on enrollment ( studies 1 and 2 ) and after intervention ( study 2 ) .\
RESULTS	Study 1 demonstrated significant correlations between insulin sensitivity and plasma adiponectin , high-density lipoprotein cholesterol , plasminogen activator inhibitor 1 , interleukin 6 , tumor necrosis factor , and triglycerides .\
RESULTS	Insulin sensitizer therapy significantly improved insulin sensitivity , inflammatory cytokines except interleukin 6 , and thrombotic factors except fibrinogen , without concomitant changes in weight , blood pressure , or body composition .\
CONCLUSIONS	Insulin sensitizer therapy ameliorates inflammatory and thrombotic factors implicated in developing CVD .\
CONCLUSIONS	Interventions to improve insulin sensitivity may thus be considered as therapeutic options to reduce CVD burden in insulin-resistant states , although further research is needed to determine long-term effects on morbidity and mortality .\
\
###7612535\
OBJECTIVE	To compare the efficacy and safety of tranexamic acid and norethisterone in the treatment of ovulatory menorrhagia .\
METHODS	A randomised , double-blind , placebo controlled study .\
METHODS	University Department of Obstetrics and Gynaecology , Addenbrooke 's Hospital , Cambridge .\
METHODS	One hundred and three women complaining of heavy periods with a regular cycle recruited directly from general practitioners within the hospital catchment area and from consultants ' gynaecology clinics .\
METHODS	There were forty-six women on placebo with confirmed ovulatory menorrhagia , defined as menstrual blood loss greater than 80 ml/cycle and mid-luteal serum progesterone concentration greater than 9 nmol/l ) .\
METHODS	Twenty-one received norethisterone ( 5 mg twice a day on days 19 and 26 ) and 25 received tranexamic acid ( 1 g four times daily on days 1 to 4 ) for two cycles .\
METHODS	Menstrual blood loss was measured using the alkaline haematin method .\
METHODS	Haematological assessments were made both at the beginning and at the end of the study , questionnaires were given to assess subjective endpoints , and patients were asked to report any adverse events during all cycles .\
RESULTS	Tranexamic acid reduced mean menstrual blood loss by 45 % , from 175 ml to 97 ml ( 95 % CI for the difference in menstrual blood loss 52 to 108 , P < 0.0001 ) , norethisterone increased mean blood loss by 20 % from 173 ml to 208 ml ( 95 % CI for the difference in menstrual blood loss -64 to 2 , P = 0.26 ) .\
RESULTS	Fourteen ( 56 % ) women who received tranexamic acid achieved a mean menstrual loss of less than 80 ml per cycle during treatment , but only two ( 9.5 % ) who received norethisterone achieved this mean menstrual loss .\
RESULTS	There were no serious adverse events reported for either drug .\
CONCLUSIONS	Tranexamic acid is a safe and effective form of medical therapy in women with menorrhagia and is highly likely to normalise blood loss in women losing 80 to 200 ml prior to treatment .\
CONCLUSIONS	Norethisterone at this dose is not effective therapy for ovulatory menorrhagia .\
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###15208226\
OBJECTIVE	To determine the safety of minor injuries telemedicine compared with on-site specialist care , current practice , and a robust gold standard , and to assess the clinical effectiveness of this new technique .\
METHODS	Patients presenting to a peripheral hospital within 10 days of injury were separately assessed by each of : an emergency medicine specialist based at a district general hospital using telemedicine , a second on-site emergency medicine specialist , and an on-site general practitioner ( representing current practice ) .\
METHODS	The primary outcome measure was discrepancies between these three medical assessments and a gold standard .\
METHODS	All patients were subsequently randomised to follow one of the independent treatment plans generated by the above assessments .\
METHODS	Secondary outcomes were recovery and further use of healthcare services measured seven days after recruitment , and consultation duration .\
RESULTS	600 patients were recruited over a 12 month period .\
RESULTS	Overall , 73 discrepancies were identified , with 12 important over-treatments and 11 important under-treatments .\
RESULTS	No consultation modality was clearly superior to any other , and there were no statistically significant differences in the secondary outcomes of clinical effectiveness measured at seven days .\
RESULTS	The mean duration of a telemedicine consultation ( 6.0 min ) was almost twice as long as an on-site specialist ( 3.1 min ) or on-site general practitioner consultation ( 3.4 min ) ( p < 0.0001 in both cases ) .\
CONCLUSIONS	Minor injuries telemedicine is safe and clinically effective , providing care that is equivalent to specialist on-site assessment and the current practice of treatment by a general practitioner .\
CONCLUSIONS	There is no evidence that telemedicine provides superior care , and there are a number of process issues that may impede successful implementation of this new technique .\
\
###12296779\
OBJECTIVE	The experimental gingivitis model is a well-established method in comparing the chemical antiplaque activity of agents and products .\
OBJECTIVE	The aim of the present study was to use time in order to achieve an exit level of bleeding on probing ( BOP ) as the primary outcome variable .\
METHODS	The study was a single blind , randomised four treatment parallel group design employing 76 healthy volunteers .\
METHODS	The cohort was accepted into the study proper if they achieved a level of < / = 25 % BOP after a 5-week pre-study oral hygiene phase .\
METHODS	At baseline , 1 , 2 , 3 , 4 , 5 weeks BOP , modified gingival index ( MGI ) and plaque index scores were obtained from each subject .\
METHODS	After baseline , oral hygiene was suspended and subjects rinsed twice daily with one of the test rinses , namely : 1 0.05 % cetylpyridinium chloride 2 Control fluoride 3 0.2 % chlorhexidine 4 0.3 % triclosan Subjects were removed from the study when they achieved > / = 50 % BOP .\
METHODS	Using the baseline and exit BOP , MGI and plaque , a deterioration rate for each parameter was derived and used as the unit of analysis .\
RESULTS	There were highly significant treatment differences for all three parameters .\
RESULTS	Paired analyses revealed chlorhexidine was highly significantly more effective than the other rinses for all three parameters .\
RESULTS	CPC and triclosan were not different from the control for BOP , but CPC was significantly different from the control for MGI and plaque , and triclosan was different from the control for plaque .\
RESULTS	There were no differences between the CPC and triclosan rinses .\
CONCLUSIONS	The method achieved the expected result of differentiating between the chlorhexidine and the other rinses .\
CONCLUSIONS	Some modification of the method , primarily to group sizes , should improve specificity .\
CONCLUSIONS	The method has the considerable volunteer appeal of early exit , particularly when allocated to control or low activity treatments for plaque .\
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###11673772\
OBJECTIVE	To determine the influence of age on the ability to adjust macronutrient oxidation to changes in diet composition .\
OBJECTIVE	Our hypothesis was that the ability to adjust macronutrient oxidation to changes in diet composition would be impaired with age .\
METHODS	Cross-sectional , randomized to three different isocaloric diets containing a constant percentage protein but varying in percentage fat and percentage carbohydrate : mixed diet ( M ; 15/30/55 ) ; high-fat diet ( HF ; 15/60/25 ) , and high-carbohydrate ( HC ; 15/15/70 ) .\
METHODS	Six young ( YM ; age = 25 + / -1 y ) and five middle-aged and older men ( OM ; age = 63 + / -3 y ) .\
METHODS	Each subject underwent 24 h whole-room calorimetry on day 4 of each diet to determine 24 h macronutrient oxidation rates .\
METHODS	Macronutrient balance was calculated from the individual macronutrient oxidation rates and the corresponding macronutrient intake .\
RESULTS	Body mass , percentage fat , and fat-free mass were similar in the two groups .\
RESULTS	Twenty-four-hour energy expenditure ( EE ) and energy balance did not differ across diets or between groups ; 24 h EE was approximately 7 % lower ( NS ) in the OM .\
RESULTS	Macronutrient oxidation rates were not significantly different in YM vs OM during M. Protein oxidation was similar across diets , but higher ( P < 0.05 ) in OM .\
RESULTS	Fat oxidation contributed 28.8 + / -7.0 % vs 37.8 + / -4.7 % to 24 h EE on M ( NS ) in the OM vs YM , respectively .\
RESULTS	This increased to 58.4 + / -6.7 vs 51.9 + / -5.3 % of 24 h EE ( NS ) in the OM vs YM , respectively , during HF and decreased to 25.4 + / -9.7 vs 20.2 + / -14.3 % ( NS ) during HC ( diet effect , both P < 0.05 ) .\
RESULTS	Carbohydrate oxidation contributed 54.3 + / -10.5 % vs 56.6 + / -2.4 % of 24 h EE ( NS ) on M in the OM vs YM , respectively .\
RESULTS	This decreased to 19.5 + / -10.6 vs 29.9 + / -12.6 % ( NS ) during HF and increased to 53.6 + / -12.3 vs 64.7 + / -14.3 % ( NS ) in the OM vs YM , respectively during HC ( diet effect , P < 0.05 ) .\
CONCLUSIONS	Taken together , these results suggest that the ability to adjust macronutrient oxidation to changes in diet composition is maintained in OM and , thus , is unlikely to contribute to the increased susceptibility to weight gain and obesity development that accompanies aging .\
\
###12006419\
OBJECTIVE	Acupuncture traditionally has been used to treat asthma .\
OBJECTIVE	Nevertheless , only a few controlled studies have been performed to determine the efficacy of this treatment .\
OBJECTIVE	Our study aimed to determine the efficacy of acupuncture in patients with moderate persistent asthma .\
METHODS	Twenty-three patients with moderate persistent asthma who had been treated only with inhaled beta ( 2 ) - agonists were randomly assigned to receive four sessions of real acupuncture ( RA ) or sham acupuncture ( SA ) in a blinded manner .\
METHODS	After a washout period of 3 weeks , the patients were crossed over .\
METHODS	Monitoring included FEV ( 1 ) , methacholine challenge , daily peak flow ( PF ) variability , and the keeping of an asthma diary .\
RESULTS	Twenty of 23 patients completed the study .\
RESULTS	There was no significant change in FEV ( 1 ) following treatment .\
RESULTS	The mean ( + / - SE ) FEV ( 1 ) values before and after the RA were 73 + / - 4 % and 73 + / - 3 % , respectively ( not significant [ NS ] ) .\
RESULTS	FEV ( 1 ) values before and after SA were 70 + / - 3 % and 70 + / - 3 % , respectively ( NS ) .\
RESULTS	There was also no change in provocative methacholine concentration causing a 20 % fall in FEV ( 1 ) ( PC ( 20 ) ) before and after treatment .\
RESULTS	The mean PC ( 20 ) values before and after RA were 0.92 + / - 0.42 mg/mL and 1.16 + / - 0.51 mg/mL , respectively ( p = 0.71 ) , while the PC ( 20 ) values before and after SA were 1.47 + / - 0.83 mg/mL and 1.11 + / - 0.79 mg/mL , respectively ( p = 0.59 ) .\
RESULTS	There was no change in the mean PF variability before and after the RA ( 1.6 + / - 3.1 % and 1.8 + / - 2.3 % , respectively [ NS ] ) .\
RESULTS	The PF variability before and after SA were 3.6 + / - 2.8 % and 2.8 + / - 3.4 % , respectively ( NS ) .\
RESULTS	No significant difference was demonstrated for symptom scores or for the use of beta ( 2 ) - agonist inhalers ( RA , 6.7 + / - 3.4 ; SA , 8.1 + / - 3.6 ; p = 0.58 ) .\
CONCLUSIONS	In patients with moderate persistent asthma , a short course of acupuncture treatment resulted in no change in lung functions , bronchial hyperreactivity , or patient symptoms .\
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###22414200\
BACKGROUND	Studies that compare health-related quality of life ( HRQOL ) and other patient-reported outcomes in different populations rest on the assumption that the measure has equivalent psychometric properties across groups .\
BACKGROUND	This study examined the measurement equivalence ( ME ) of the 36-item Medical Outcomes Study Short Form Survey ( SF-36 ) , a widely-used measure of HRQOL , by sex and race in a population-based Canadian sample .\
RESULTS	SF-36 data were from the Canadian Multicentre Osteoporosis Study , a prospective cohort study that randomly sampled adult men and women from nine sites across Canada .\
RESULTS	Confirmatory factor analysis ( CFA ) techniques were used to test hypotheses about four forms of ME , which are based on equality of the factor loadings , variances , covariances , and intercepts .\
RESULTS	Analyses were conducted for Caucasian and non-Caucasian females ( n = 6,539 ) and males ( n = 2,884 ) .\
RESULTS	CFA results revealed that a measurement model with physical and mental health factors provided a good fit to the data .\
RESULTS	All forms of ME were satisfied for the study groups .\
CONCLUSIONS	The results suggest that sex and race do not influence the conceptualization of a general measure of HRQOL in the Canadian population .\
\
###16903880\
OBJECTIVE	To validate and quantify the impact of insecticide-treated bednets ( ITN ) on malaria morbidity and mortality in Cambodia .\
METHODS	A paired , cluster-randomized trial of ITN was conducted in Rattanakiri , North East Cambodia .\
METHODS	Thirty-four villages with a total population of 10,726 were randomized to receive deltamethrin-impregnated bednets or to control ( no net provision ) .\
METHODS	Cross-sectional surveys measured Plasmodium falciparum prevalence at baseline and 10 months after ITN distribution .\
METHODS	Village malaria volunteers in control and intervention villages treated dipstick-positive P. falciparum cases with artesunate and mefloquine .\
METHODS	The resulting passive surveillance data were used as an estimate of the incidence of clinical P. falciparum infections .\
RESULTS	There was a protective efficacy of 28 % in P. falciparum incidence ( adjusted rate ratio 0.72 , 95 % CI 0.47-1 .08 ) and 9 % in P. falciparum prevalence ( adjusted prevalence ratio 0.91 , 95 % CI 0.65-1 .28 ) in ITN relative to control villages ; however , neither of these estimates reached statistical significance .\
RESULTS	Individual-level analysis indicated a greater reduction in P. falciparum prevalence among under 5-year-olds ( adjusted OR = 0.63 , 95 % CI 0.26-1 .53 ) compared to older individuals ( interaction P = 0.042 ) .\
RESULTS	The protective efficacy of 35 % ( 95 % CI -28 , 67 % ) with respect to clinical P. falciparum incidence in under 5-year-olds was more pronounced than the corresponding estimates for prevalence but was again not significant .\
CONCLUSIONS	Lack of statistical significance in the results is likely to be due to a lack of power .\
CONCLUSIONS	The analysis provides further evidence for ITN effectiveness in South East Asia , particularly among individuals under 5 years of age .\
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###16477259\
BACKGROUND	Inflammatory processes may be involved in the development of dementia , although findings from epidemiologic studies directly examining inflammatory markers and dementia or its precursor , impaired cognitive function , are inconsistent .\
METHODS	We measured plasma levels of the inflammatory marker , C-reactive protein , using a high-sensitivity assay ( hs-CRP ) in 4,231 older participants of the Women 's Health Study , who provided blood samples between 1992 and 1996 when they were age 60 to 90 years .\
METHODS	From 1998 to 2000 , we administered a battery of 5 cognitive tests measuring general cognition , verbal memory , and category fluency .\
METHODS	Using multiple linear regression , we compared mean cognitive test scores across quintiles of hs-CRP , adjusting for potential confounding factors .\
RESULTS	There was a wide distribution of hs-CRP levels among these women , and a large proportion had levels considered to reflect a high risk of cardiovascular disease .\
RESULTS	We observed no suggestion , however , that higher hs-CRP levels were associated with poorer cognitive performance .\
RESULTS	For example , on a global score combining results of all the cognitive tests , mean scores among women in the highest quintile of hs-CRP did not differ from those in the lowest quintile ( multivariable-adjusted mean difference = 0.04 ; 95 % confidence interval [ CI ] : -0.02 to 0.11 , P for trend across quintiles = 0.38 ) .\
CONCLUSIONS	Overall , in these women , we found no evidence of a link between hs-CRP , a marker of inflammation , and decrements in cognitive function .\
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###7722117\
OBJECTIVE	We studied the relations between heart failure , ejection fraction , arrhythmia suppression and mortality .\
BACKGROUND	Both left ventricular ejection fraction and functional class of heart failure are strongly associated with mortality after acute myocardial infarction .\
BACKGROUND	Both are also related to the presence of ventricular arrhythmias and have been identified as factors related to the ability to suppress ventricular arrhythmias .\
BACKGROUND	Little has been reported about the relations between these two factors and arrhythmia suppression or mortality .\
METHODS	Baseline data from the Cardiac Arrhythmia Suppression Trial were used to define several categories of heart failure and to relate both the resulting categories and ejection fraction to arrhythmia suppression and mortality using logistic and survival regression analytic methodologies .\
RESULTS	Regardless of the prospective baseline definition of heart failure used , the data consistently showed that heart failure was a more powerful predictor of subsequent congestive heart failure events and arrhythmia suppression and was equally powerful in predicting death .\
RESULTS	However , each variable provided incremental information when included in the prediction model .\
RESULTS	Heart failure and ejection fraction appeared to be independent predictors of death .\
RESULTS	Interactions were observed : A low ejection fraction was more predictive of failure of arrhythmia suppression in patients with than without evidence of heart failure before or at baseline ; a low ejection fraction was more predictive of subsequent congestive heart failure events in patients without than with evidence of heart failure before or at baseline .\
CONCLUSIONS	Although heart failure as a prognostic feature appears to be somewhat superior to ejection fraction , both are powerful predictors of arrhythmia suppression and cardiac events in patients with ventricular arrhythmia after myocardial infarction .\
CONCLUSIONS	Each provides incremental prediction .\
\
###18953215\
OBJECTIVE	Worksite health promotion programs use health risk appraisal ( HRA ) surveys to identify employees at increased risk , then provide a range of interventions to encourage high-risk individuals to improve their health .\
OBJECTIVE	Our objective was to determine how the intensity of intervention after HRA affected cardiovascular risk after 1 year , comparing individual follow-up counseling with environmental supports .\
METHODS	133 employees of Vanderbilt University with cardiovascular risk factors were randomly assigned to worksite HRA plus targeted disease management ( DM group ) or HRA plus information about worksite health promotion programs ( HRA group ) .\
METHODS	The DM group received longitudinal individualized counseling for risk reduction , whereas the HRA group members received one feedback session about their risk factors and information about free worksite health promotion programs .\
METHODS	The main outcome measure was the difference between groups in the change in average Framingham risk score from baseline to 1 year .\
RESULTS	There was no significant baseline difference between groups in the Framingham risk score .\
RESULTS	Among DM participants , the mean ( SD ) Framingham risk score decreased by 22.6 % ; among HRA participants , the mean score rose by 4.3 % ( P = .017 for the difference between groups ) .\
CONCLUSIONS	In this study of employees with cardiovascular risk factors , HRA followed by individual counseling was more effective than providing information about free worksite health promotion programs .\
\
###22696580\
BACKGROUND	Patients who present with only simple or complex partial seizures have a poorly documented prognosis .\
BACKGROUND	Treatment may be advocated to prevent future secondary generalised seizures , reduce the frequency of further simple or complex partial seizures or a combination of both .\
METHODS	A full statistical analysis on 1334 patients was carried out .\
METHODS	The outcomes measured were post-randomisation times to first seizure of any type and first tonic-clonic seizure .\
METHODS	Methodology was adopted that accounted for individuals ' underlying pre-randomisation seizure counts and allowed for the possibility that there may be a proportion of the sample that will not experience post-randomisation seizure recurrence .\
RESULTS	103 subjects randomised to the MESS ( Multicentre Study of Early Epilepsy and Single Seizures ) study had only partial seizures at randomisation .\
RESULTS	Only 17 of these had a tonic-clonic seizure during follow-up .\
RESULTS	The presence of an abnormal EEG at randomisation influenced this risk : an estimated 23 % of those with EEG abnormality were at risk of tonic-clonic seizures during follow-up compared with 16 % of those with a normal EEG .\
RESULTS	The group did , however , continue to have partial seizures during follow-up , and modelling showed that the impact of treatment on these seizures was significantly less than the effects of treatment on the frequency of tonic-clonic seizures in those patients with such pre-randomisation seizures .\
CONCLUSIONS	Patients presenting with a history of only partial seizures are at low risk of subsequent tonic-clonic seizures in the period of time to which therapeutic decisions are relevant .\
CONCLUSIONS	The effects of the antiepileptic drugs used in the MESS study are greater for tonic-clonic seizures than they are for partial seizures .\
\
###15056522\
OBJECTIVE	Inhibition mediated by gamma-aminobutyric acid at the axon initial segment of pyramidal neurons appears to be altered in the prefrontal cortex in schizophrenia .\
OBJECTIVE	This study examined the densities and laminar distribution of axon initial segments labeled with an antibody against the serotonin ( 1A ) ( 5-HT ( 1A ) ) receptor , which also mediates inhibitory regulation of pyramidal neurons , in subjects with schizophrenia .\
METHODS	The densities and laminar distribution of axon initial segments with 5-HT ( 1A ) - like immunoreactivity were assessed in postmortem tissue from the prefrontal cortex ( Brodmann 's area 46 ) of 14 matched triads of subjects with schizophrenia , subjects with major depressive disorder , and comparison subjects with no psychiatric disorder .\
RESULTS	The relative densities of the labeled axon initial segment in both the superficial and the deep cortical layers did not differ across the three subject groups .\
CONCLUSIONS	The findings do not support a role for altered serotonin transmission by means of the 5-HT ( 1A ) receptor in dysfunction of prefrontal cortex pyramidal neurons in schizophrenia .\
\
###9583863\
BACKGROUND	Immunosuppression in patients with hepatitis C virus ( HCV ) following orthotopic liver transplantation can lead to significant increases in serum viral loads .\
BACKGROUND	Our aim was to analyze the effect of a randomized study of two immunosuppressive agents ( tacrolimus vs. microemulsion cyclosporine ) on the outcome of HCV patients following orthotopic liver transplantation .\
METHODS	From December 1995 to September 1996 , 50 adult patients transplanted for HCV cirrhosis were randomly assigned to receive tacrolimus ( Prograf ) ( group 1 , 25 patients ) or microemulsion cyclosporine ( Neoral ) ( group 2 , 24 patients ) .\
METHODS	All patients received alpha-interferon after transplantation , and the overall steroid doses were no different between the groups .\
METHODS	Serum RNA levels were measured by signal amplification of Chiron .\
METHODS	Biopsies were taken when transaminases were greater than 2x base line or when there was an inappropriate response to alterations in immunosuppression regimens .\
RESULTS	There were more episodes of rejection in the Neoral group , but there were no differences in bacterial and viral infections , nor in the rate of HCV recurrence between the two groups .\
RESULTS	There were seven deaths in group 1 and eight in group 2 .\
RESULTS	Overall patient and graft survival rates in the Prograf and Neoral groups at 18 months were 72 and 68 % and 67 and 64 % , respectively .\
CONCLUSIONS	( a ) Both immunosuppression regimens had similar HCV recurrence rates ; ( b ) there were no differences in bacterial or opportunistic infections ; and ( c ) patient and graft survival was similar between the two groups .\
\
###16041731\
OBJECTIVE	The aim of this randomized , double-blind , placebo-controlled trial was to investigate the effectiveness and side effects of a phytotherapeutic agent with Matricariae recutita , Foeniculum vulgare and Melissa officinalis in the treatment of infantile colic .\
METHODS	93 breastfed colicky infants were enrolled , the diagnosis was made according to Wessel 's criteria .\
METHODS	After a 3 day observation period , the infants were randomly divided into two groups , one treated with phytotherapeutic agent ( PA ) and the other with placebo twice a day for 1 week .\
METHODS	Crying time and side effects were recorded .\
RESULTS	88 infants completed the trial : 41 in the PA group and 47 in the control .\
RESULTS	The daily average crying time for the PA was 201.2 min/day ( SD 18.3 ) at the baseline and 76.9 min/day ( SD 23.5 ) at the end of the study ; for the placebo it was 198.7 min/day ( SD 16.9 ) and 169.9 min/day ( SD 23.1 ) ( p < 0.005 ) .\
RESULTS	Crying time reduction was observed in 85.4 % subjects for the PA and in 48.9 % subjects for the placebo ( p < 0.005 ) .\
RESULTS	No side effects were reported .\
CONCLUSIONS	The present study shows that colic in breastfed infant improves within 1 week of treatment with an extract based on Matricariae recutita , Foeniculum vulgare and Melissa officinalis .\
\
###20580201\
BACKGROUND	Pain and depression are two of the most prevalent and treatable cancer-related symptoms , each present in at least 20 % -30 % of oncology patients .\
OBJECTIVE	To determine the associations of pain and depression with health-related quality of life ( HRQL ) , disability , and health care use in cancer patients .\
METHODS	The Indiana Cancer Pain and Depression study is a randomized clinical trial comparing telecare management vs. usual care for patients with cancer-related pain and/or clinically significant depression .\
METHODS	In this article , baseline data on patients enrolled from 16 urban or rural community-based oncology practices are analyzed to test the associations of pain and depression with HRQL , disability , and health care use .\
RESULTS	Of the 405 participants , 32 % had depression only , 24 % pain only , and 44 % both depression and pain .\
RESULTS	The average Hopkins Symptom Checklist 20-item depression score in the 309 depressed participants was 1.64 ( on 0-4 scale ) , and the average Brief Pain Inventory ( BPI ) severity score in the 274 participants with pain was 5.2 ( on 0-10 scale ) , representing at least moderate levels of symptom severity .\
RESULTS	Symptom-specific disability was high , with participants reporting an average of 16.8 of the past 28 days ( i.e. , 60 % of their days in the past four weeks ) in which they were either confined to bed ( 5.6 days ) or had to reduce their usual activities by 50 % ( 11.2 days ) because of pain or depression .\
RESULTS	Moreover , 176 ( 43 % ) participants reported being unable to work because of health-related reasons .\
RESULTS	Depression and pain had both individual and additive adverse associations with quality of life .\
RESULTS	Most patients were currently not receiving care from a mental health or pain specialist .\
CONCLUSIONS	Depression and pain are prevalent and disabling across a wide range of types and phases of cancer , commonly co-occur , and have additive adverse effects .\
CONCLUSIONS	Enhanced detection and management of this disabling symptom dyad is warranted .\
\
###25444222\
BACKGROUND	Up to 25 % of severely injured patients develop trauma-induced coagulopathy .\
BACKGROUND	To study interventions for this vulnerable population for whom consent can not be obtained easily , the Food and Drug Administration issued regulations for emergency research with an exception from informed consent ( ER-EIC ) .\
BACKGROUND	We describe the community consultation and public disclosure ( CC/PD ) process in preparation for an ER-EIC study , namely the Control Of Major Bleeding After Trauma ( COMBAT ) study .\
METHODS	The CC/PD was guided by the four bioethical principles .\
METHODS	We used a multimedia approach , including one-way communications ( newspaper ads , brochures , television , radio , and web ) and two-way communications ( interactive in-person presentations at community meetings , printed and online feedback forms ) to reach the trials catchment area ( Denver County 's population : 643,000 and the Denver larger metro area where commuters reside : 2.9 million ) .\
METHODS	Particular attention was given to special-interests groups ( eg , Jehovah Witnesses , homeless ) and to Spanish-speaking communities ( brochures and presentations in Spanish ) .\
METHODS	Opt-out materials were available during on-site presentations or via the COMBAT study website .\
RESULTS	A total of 227 community organizations were contacted .\
RESULTS	Brochures were distributed to 11 medical clinics and 3 homeless shelters .\
RESULTS	The multimedia campaign had the potential to reach an estimated audience of 1.5 million individuals in large metro Denver area , the majority via one-way communication and 1900 in two-way communications .\
RESULTS	This resource intensive process cost more than $ 84,000 .\
CONCLUSIONS	The CC/PD process is resource-intensive , costly , and complex .\
CONCLUSIONS	Although the multimedia CC/PD reached a large audience , the effectiveness of this process remains elusive .\
CONCLUSIONS	The templates can be helpful to similar ER-EIC studies .\
\
###20339034\
BACKGROUND	There has been growing concern that linear ablation is associated with an increased risk of iatrogenic arrhythmias in patients undergoing ablation for atrial fibrillation ( AF ) .\
BACKGROUND	Therefore , we compared circumferential pulmonary vein ablation plus left atrial linear ablation ( CPVA+LALA ) with segmental pulmonary vein isolation ( PVI ) in patients with paroxysmal AF .\
RESULTS	Sixty-six consecutive patients with paroxysmal AF were prospectively randomly assigned to receive PVI versus CPVA+LALA ( consisting of encircling lesions around the pulmonary veins ) , a roof line , and a mitral isthmus line with documentation of bidirectional mitral isthmus block .\
RESULTS	All patients were seen at 1 , 3 , 6 , and every 12 months after ablation , with 14-day continuous ECG monitoring every 6 months .\
RESULTS	At 16.4 + / -6.3 months after 1 ablation procedure , 19 patients ( 58 % ) remained free of atrial arrhythmias after PVI versus 17 patients ( 51 % ) after CPVA+LALA ( P = 0.62 ) .\
RESULTS	After PVI , 14 patients had recurrent paroxysmal AF , whereas after CPVA+LALA , 8 patients had recurrent AF , 6 had atypical left atrial flutter ( LAFL ) , and 2 had both AF and LAFL ( P = 0.32 between PVI versus CPVA+LALA for AF but P = 0.002 for LAFL ) .\
RESULTS	Twenty-eight patients ( 85 % ) remained arrhythmia-free after 1.3 + / -0.5 PVI procedures versus 28 patients ( 85 % ) after 1.4 + / -0.6 CPVA+LALA procedures ( P = NS ) .\
RESULTS	Fluoroscopy time was longer after CPVA+LALA versus PVI ( 91 versus 73 minutes , P = 0.04 ) .\
CONCLUSIONS	As an initial ablation approach in patients with paroxysmal AF , more LAFL occurred after CPVA+LALA and fluoroscopy times were longer compared with segmental PVI .\
\
###20043800\
OBJECTIVE	To assess the effect of food containing high concentrations of fish oil omega-3 fatty acids and a low omega-6-omega-3 fatty acid ratio on clinical signs of osteoarthritis in dogs .\
METHODS	Randomized , double-blinded , controlled clinical trial .\
METHODS	127 client-owned dogs with osteoarthritis in 1 or more joints from 18 privately owned veterinary clinics .\
METHODS	Dogs were randomly assigned to be fed for 6 months with a typical commercial food or a test food containing a 31-fold increase in total omega-3 fatty acid content and a 34-fold decrease in omega-6-omega-3 ratio , compared with the control food .\
METHODS	Dog owners completed a questionnaire about their dog 's arthritic condition , and investigators performed a physical examination and collected samples for a CBC and serum biochemical analyses ( including measurement of fatty acids concentration ) at the onset of the study and at 6 , 12 , and 24 weeks afterward .\
RESULTS	Dogs fed the test food had a significantly higher serum concentration of total omega-3 fatty acids and a significantly lower serum concentration of arachidonic acid at 6 , 12 , and 24 weeks .\
RESULTS	According to owners , dogs fed the test food had a significantly improved ability to rise from a resting position and play at 6 weeks and improved ability to walk at 12 and 24 weeks , compared with control dogs .\
CONCLUSIONS	Ingestion of the test food raised blood concentrations of omega-3 fatty acids and appeared to improve the arthritic condition in pet dogs with osteoarthritis .\
\
###9517642\
OBJECTIVE	Patients in most trials of pharmacotherapy for nonorganic dyspepsia have been groups referred selectively for endoscopy , which could have led to a selection bias of nonresponders , explaining the negative outcome of most controlled treatment trials in nonorganic dyspepsia .\
OBJECTIVE	The aim of this study was to evaluate the effects of cisapride and nizatidine in patients with nonorganic dyspepsia who were recruited directly from primary care settings , and to evaluate the therapeutic implications of dyspepsia subgrouping .\
METHODS	A consecutive series of patients who consulted their general practitioner with dyspepsia were invited to an interview and endoscopy .\
METHODS	Before endoscopy , symptoms were classified as reflux-like , dysmotility-like , ulcer-like , or unclassifiable .\
METHODS	A total of 330 patients with either minor or no abnormalities at endoscopy were randomized to double blind treatment with cisapride 10 mg t.i.d. , nizatidine 300 mg at night , or placebo for 2 wk .\
RESULTS	A symptomatic response was found in 62 % of patients on cisapride ( therapeutic gain cisapride vs placebo : 0.1 % [ 95 % confidence interval -14 % to 14 % ] ) and in 54 % of patients on nizatidine ( therapeutic gain nizatidine vs placebo : -8 % [ 95 % confidence interval -22 % to 7 % ] ) .\
RESULTS	Response to treatment was independent of symptom classification .\
CONCLUSIONS	The effects of a 2-wk course of cisapride or nizatidine in unselected patients with dyspepsia recruited from primary care were not superior to those of placebo .\
CONCLUSIONS	Symptom subgrouping was not predictive of response to therapy .\
\
###8425695\
BACKGROUND	Effective treatment for primary biliary cirrhosis ( PBC ) resulting in slower progression and improved survival remains elusive .\
BACKGROUND	Cyclosporin A ( CyA ) , which has been so effective in preventing human allograft rejection , has shown promise in small numbers of patients in early studies .\
METHODS	Three hundred forty-nine patients with PBC were randomized to receive CyA , 3 mg.kg-1 .\
METHODS	day-1 , or placebo in a multicenter study with follow-up for 6 years .\
METHODS	The end point was death or liver transplantation .\
RESULTS	Cox multivariate analysis showed time from entry to death or transplantation was significantly prolonged ( by up to 50 % ) in the CyA-treated group .\
RESULTS	Liver-related mortality was also significantly lower .\
RESULTS	However , a univariate analysis of survival showed no statistical differences between the two groups .\
RESULTS	Biochemical liver indices deteriorated more slowly in the CyA-treated group , but serum creatinine concentration was elevated > 150 mumol/L in 9 % , necessitating permanent discontinuation in half of these .\
RESULTS	A reduction in the dose of CyA was required in 11 % because of hypertension .\
CONCLUSIONS	CyA has some therapeutic potential in primary biliary cirrhosis , providing blood pressure and renal function are closely monitored .\
\
###15805455\
OBJECTIVE	To evaluate the effect on the process of care of an active strategy to implement clinical guidelines on physiotherapy for low back pain .\
METHODS	A cluster randomised controlled trial comparing an active strategy with standard dissemination .\
METHODS	Primary care physiotherapy practices .\
METHODS	113 physiotherapists were randomly allocated to receive the guidelines by mail ( control group ) or to receive an additional active strategy ( intervention group ) which consisted of a multifaceted programme including education , discussion , role playing , feedback , and reminders .\
METHODS	Adherence to the guidelines was measured by means of individual patients ' forms recording the treatment completed by the physiotherapist .\
METHODS	The forms were assessed using an algorithm based on the number of treatment sessions , treatment goals , interventions , and patient education .\
RESULTS	Physiotherapists in the intervention group more often correctly limited the number of treatment sessions for patients with a normal course of back pain ( OR 2.39 ; 95 % CI 1.12 to 5.12 ) , more often set functional treatment goals ( OR 1.99 ; 95 % CI 1.06 to 3.72 ) , more often used mainly active interventions ( OR 2.79 ; 95 % CI 1.19 to 6.55 ) , and more often gave adequate patient education ( OR 3.59 ; 95 % CI 1.35 to 9.55 ) .\
RESULTS	They also adhered more to all four criteria ( OR 2.05 ; 95 % CI 1.15 to 3.65 ) .\
CONCLUSIONS	The active strategy moderately improved adherence to the guidelines .\
CONCLUSIONS	Active strategies are recommended to implement the clinical guidelines on physiotherapy for low back pain .\
\
###18664276\
BACKGROUND	Knee Osteoarthritis ( KOA ) is a major cause of pain and functional impairment among elders .\
BACKGROUND	Currently , there are neither feasible preventive intervention strategies nor effective medical remedies for the management of KOA .\
BACKGROUND	Tai Chi , an ancient Chinese mind-body exercise that is reported to enhance muscle function , balance and flexibility , and to reduce pain , depression and anxiety , may safely and effectively be used to treat KOA .\
BACKGROUND	However , current evidence is inconclusive .\
BACKGROUND	Our study examines the effects of a 12-week Tai Chi program compared with an attention control ( wellness education and stretching ) on pain , functional capacity , psychosocial variables , joint proprioception and health status in elderly people with KOA .\
BACKGROUND	The study will be completed by July 2009 .\
METHODS	Forty eligible patients , age > 55 yr , BMI < or = 40 kg/m2 with tibiofemoral osteoarthritis ( American College of Rheumatology criteria ) are identified and randomly allocated to either Tai Chi ( 10 modified forms from classical Yang style Tai Chi ) or attention control ( wellness education and stretching ) .\
METHODS	The 60-minute intervention sessions take place twice weekly for 12 weeks .\
METHODS	The study is conducted at an urban tertiary medical center in Boston , Massachusetts .\
METHODS	The primary outcome measure is the Western Ontario and McMaster Universities ( WOMAC ) pain subscale at 12 weeks .\
METHODS	Secondary outcomes include weekly WOMAC pain , function and stiffness scores , patient and physician global assessments , lower-extremity function , knee proprioception , depression , self-efficacy , social support , health-related quality of life , adherence and occurrence of adverse events after 12 , 24 and 48 weeks .\
CONCLUSIONS	In this article , we present the challenges of designing a randomized controlled trial with long-term follow up .\
CONCLUSIONS	The challenges encountered in this design are : strategies for recruitment , avoidance of selection bias , the actual practice of Tai Chi , and the maximization of adherence/follow-up while conducting the clinical trial for the evaluation of the effectiveness of Tai Chi on KOA .\
BACKGROUND	ClinicalTrials.gov identifier : NCT00362453 .\
\
###23370316\
BACKGROUND	We conducted a phase II study of dual-agent monoclonal antibody therapy consisting of cetuximab and bevacizumab in combination with paclitaxel and carboplatin chemotherapy in non-small-cell lung cancer .\
METHODS	Patients with stage IIIB/IV nonsquamous non-small-cell lung cancer randomly received cetuximab ( 400 mg/m initially , 250 mg/m weekly thereafter ) plus bevacizumab ( 15 mg/kg ) for six cycles combined with paclitaxel ( 200 mg/m ) and carboplatin ( area under the curve 6 ) for either six cycles ( six-cycle arm ) or the first three cycles ( three-cycle arm ) ( one cycle = 3 weeks ) .\
METHODS	The primary objective was progression-free survival ( PFS ) , estimated separately for each treatment arm .\
RESULTS	In 121 patients , the median PFS was 6.05 months ( 95 % confidence interval [ CI ] : 5.65 , 7.03 ) in the six-cycle arm and 4.50 months ( 95 % CI : 4.01 , 5.42 ) in the three-cycle arm .\
RESULTS	Respective median overall survival times were 12.06 months ( 95 % CI : 9.40 , 19.25 ) and 11.63 months ( 95 % CI : 6.64 , 17.61 ) .\
RESULTS	The tumor response rate was 51.7 % ( 95 % CI : 39.0 % , 64.3 % ) and 44.3 % ( 95 % CI : 31.8 % , 56.7 % ) in the six-cycle and three-cycle arms , respectively , with corresponding median response durations of 4.86 months ( 95 % CI : 4.30 , 7.16 ) and 3.94 months ( 95 % CI : 2.92 , 4.47 ) .\
RESULTS	Quality of life was consistent across arms .\
RESULTS	Cetuximab-related grade 3/4 events in greater than 5 % of patients ( six-cycle arm , three-cycle arm ) were dermatitis acneiform ( 6.9 % ; 8.6 % ) and fatigue ( 13.8 % ; 5.2 % ) .\
RESULTS	Three patients died during the study from drug-related adverse events ( one in the six-cycle arm and two in the three-cycle arm ) .\
CONCLUSIONS	Both the regimens showed expected PFS and numerically comparable overall survival .\
CONCLUSIONS	Quality of life was similar in the two arms , and both the regimens were well tolerated .\
\
###19918859\
BACKGROUND	Nitric oxide donors such as isosorbide dinitrate ( ISDN ) are considered the first choice of treatment for anal fissure .\
BACKGROUND	After reports of the successful treatment of such fissures with botulinum toxin , this randomized blinded trial compared botulinum toxin with ISDN in the treatment of chronic anal fissure .\
METHODS	Patients were randomized to receive an injection of botulinum in the internal anal sphincter and a placebo ointment , or a placebo injection and ISDN ointment .\
METHODS	The primary endpoint was macroscopic fissure healing after 4 months .\
RESULTS	After 4 months macroscopic healing of the fissures was noted in 14 of 37 patients in the botulinum group and 21 of 36 in the ISDN group .\
RESULTS	Pain scores were lower among patients who received ISDN , although the difference was not significant .\
RESULTS	Side-effects were similar in the two groups .\
CONCLUSIONS	In contrast with previous reports on botulinum toxin as a therapeutic agent for anal fissure , this study found no advantage over treatment with a nitric oxide donor as regards fissure healing and fissure-related pain .\
\
###20625021\
BACKGROUND	To our knowledge , no prospective study has examined the association between vitamin D and cognitive decline or dementia .\
METHODS	We determined whether low levels of serum 25-hydroxyvitamin D ( 25 [ OH ] D ) were associated with an increased risk of substantial cognitive decline in the InCHIANTI population-based study conducted in Italy between 1998 and 2006 with follow-up assessments every 3 years .\
METHODS	A total of 858 adults 65 years or older completed interviews , cognitive assessments , and medical examinations and provided blood samples .\
METHODS	Cognitive decline was assessed using the Mini-Mental State Examination ( MMSE ) , and substantial decline was defined as 3 or more points .\
METHODS	The Trail-Making Tests A and B were also used , and substantial decline was defined as the worst 10 % of the distribution of decline or as discontinued testing .\
RESULTS	The multivariate adjusted relative risk ( 95 % confidence interval [ CI ] ) of substantial cognitive decline on the MMSE in participants who were severely serum 25 ( OH ) D deficient ( levels < 25 nmol/L ) in comparison with those with sufficient levels of 25 ( OH ) D ( > / = 75 nmol/L ) was 1.60 ( 95 % CI , 1.19-2 .00 ) .\
RESULTS	Multivariate adjusted random-effects models demonstrated that the scores of participants who were severely 25 ( OH ) D deficient declined by an additional 0.3 MMSE points per year more than those with sufficient levels of 25 ( OH ) D.\
RESULTS	The relative risk for substantial decline on Trail-Making Test B was 1.31 ( 95 % CI , 1.03-1 .51 ) among those who were severely 25 ( OH ) D deficient compared with those with sufficient levels of 25 ( OH ) D. No significant association was observed for Trail-Making Test A.\
CONCLUSIONS	Low levels of vitamin D were associated with substantial cognitive decline in the elderly population studied over a 6-year period , which raises important new possibilities for treatment and prevention .\
\
###20594464\
OBJECTIVE	To investigate the effect of early goal-directed therapy ( EGDT ) on treatment of critical patients with severe sepsis/septic shock .\
METHODS	A multi-center , prospective , randomized , controlled study was deployed .\
METHODS	Totally 314 critical patients , from eight comprehensive hospitals in Zhejiang Province admitted during January , 2005 to January , 2008 , suffering from severe sepsis/septic shock were randomized into conventional treatment group ( n = 151 ) and EGDT group ( n = 163 ) , the patients of the former underwent fluid resuscitation guided by central venous pressure ( CVP ) , systolic blood pressure ( SBP ) or mean artery pressure ( MAP ) and urinary output ( UO ) , and the latter guided by CVP , SBP or MAP and UO plus central venous oxygen saturation ( ScvO2 ) .\
METHODS	The patients were treated with fluid , blood transfusions and cardiac stimulants in a period of 6 hours after enrollment to reach the goal .\
METHODS	The difference of 28-day survival rate and intensive care unit ( ICU ) mortality ( primary end points ) , the length of ICU stay , the duration of mechanical ventilation , duration of antibiotics treatment , incidence of newly occurred infection , and severity scores ( secondary end points ) were compared between two groups .\
RESULTS	Finally , a total of 303 patients were eligible to enter this study , with 157 patients in EGDT group and 146 patients in conventional treatment group .\
RESULTS	In comparison with conventional treatment group , the 28-day survival rate of EGDT group was increased by 17.7 % ( 75.2 % vs. 57.5 % , P = 0.001 ) and the ICU mortality of EGDT group was decreased by 15.7 % ( 35.0 % vs. 50.7 % , P = 0.035 ) , the acute physiology and chronic health evaluation II ( APACHEII ) score ( 14.4 + / -8.5 vs. 18.0 + / -7.1 , P = 0.043 ) , multiple organ dysfunction syndrome ( MODS ) score ( 5.8 + / -3.1 vs. 8.9 + / -3.7 , P = 0.014 ) and sepsis-related organ failure assessment ( SOFA ) score ( 5.6 + / -2.9 vs. 10.4 + / -3.7 , P = 0.001 ) were significantly decreased in EGDT group .\
RESULTS	Meanwhile , a significant shortening of duration of using antibiotics was also found [ ( 13.4 + / -10.0 ) days vs. ( 19.7 + / -13.5 ) days , P = 0.004 ] , with a lowering of incidence of occurrence of new infection ( 37.6 % vs. 53.4 % , P = 0.014 ) .\
RESULTS	There were no differences in other parameters for secondary end points .\
CONCLUSIONS	EGDT improves 28-day survival rate and clinical scores , and it shows beneficial effects on outcome of critical patients with severe sepsis/septic shock .\
\
###11035679\
OBJECTIVE	To determine if aerosolized medications can be targeted to deposit in the smaller , peripheral airways or the larger , central airways of adult cystic fibrosis ( CF ) patients by varying particle size and inspiratory flow rate .\
METHODS	Randomized clinical trial .\
METHODS	Outpatient research laboratory .\
METHODS	Nine adult patients with CF.\
METHODS	Patients inhaled an aerosol comprised of 3.68 + / -0.04 microm saline solution droplets ( two visits ) or 1.01 + / - 0.2 microm saline solution droplets ( two visits ) for 30 s , starting from functional residual capacity and breathing at a slow or faster inspiratory flow rate .\
METHODS	On all visits , the saline solution was admixed with the radioisotope ( 99m ) Tc .\
METHODS	Immediately after inhalation , a gamma camera recorded the deposition pattern of the radioaerosol in the lungs .\
METHODS	Deposition images were analyzed in terms of the inner : outer zone ( I :O ) ratio , a measure of deposition in an inner zone ( large , central airways ) vs. an outer zone ( small airways and alveoli ) .\
RESULTS	For the 3.68-microm aerosol , I :O ratios averaged 2.29 + / -1.45 and 2.54 + / -1.48 ( p > 0.05 ) , indicating that aerosol distribution within the lungs was unchanged while breathing at 12 + / -2 L/min vs. 31 + / -5 L/min , respectively .\
RESULTS	For the 1.01-microm aerosol , I :O ratios averaged 2.09 + / -0.96 and 3.19 + / -1.95 ( p < 0.05 ) , indicating that deposition was predominantly in the smaller airways while breathing at 18 + / -5 L/min and in the larger airways while breathing at 38 + / -8 L/min , respectively .\
CONCLUSIONS	These results suggest that the targeted delivery of an aerosol to the smaller , peripheral airways or the larger , central airways of adult CF patients may be achieved by generating an aerosol comprised of approximately 1.0-microm particles and inspiring from functional residual capacity at approximately 18 L/min and approximately 38 L/min , respectively .\
\
###16156456\
BACKGROUND	A blood transfusion is a costly transplantation of tissue that may endanger the health for the recipient .\
BACKGROUND	Blood transfusions are common after total hip arthroplasty .\
BACKGROUND	The total saving potential is substantial if the blood loss could be reduced .\
BACKGROUND	Studies on the use of tranexamic acid have shown interesting results , but its benefits in total hip arthroplasty have not yet been resolved .\
METHODS	100 patients receiving a total hip arthroplasty ( THA ) got a single injection of tranexamic acid ( 15 mg/kg ) or placebo intravenously before the start of the operation .\
METHODS	The study was double-blind and randomized .\
METHODS	Total blood loss was calculated from the hemoglobin ( Hb ) balance .\
METHODS	Volume and Hb concentration of the drainage was measured 24 h after the operation .\
METHODS	Intraoperative blood loss was estimated volumetrically and visually .\
RESULTS	The patients who received tranexamic acid ( TA ) bled less .\
RESULTS	The total blood loss was on average 0.97 L in the TA group and 1.3 L in the placebo group ( p < 0.001 ) .\
RESULTS	8/47 ( 0.2 ) in the TA group were given blood transfusion versus 23/53 ( 0.4 ) in the placebo group ( p = 0.009 ) .\
RESULTS	Drainage volume and drainage Hb concentration were less in the TA group ( p < 0.001 and p = 0.001 ) .\
RESULTS	No thromboembolic complications occurred .\
CONCLUSIONS	Considering the cost of blood and tranexamic acid only , use of the drug would save EUR 47 Euro per patient .\
CONCLUSIONS	We recommend a preoperative single dose of tranexamic acid for standard use in THA .\
\
###18090078\
METHODS	Cost-utility evaluation of a randomized , controlled trial with a 4 - to 8-year follow-up .\
OBJECTIVE	To investigate the incremental cost per quality-adjusted-life-year ( QALY ) when comparing circumferential fusion to posterolateral fusion in a long-term , societal perspective .\
BACKGROUND	The cost-effectiveness of circumferential fusion in a long-term perspective is uncertain but nonetheless highly relevant as the ISSLS prize winner 2006 in clinical studies reported the effect of circumferential fusion superior to the effect of posterolateral fusion .\
BACKGROUND	A recent trial found no significant difference between posterolateral and circumferential fusion reporting cost-effectiveness from a 2-year viewpoint .\
METHODS	A total of 146 patients were randomized to posterolateral or circumferential fusion and followed 4 to 8 years after surgery .\
METHODS	The mean age of the cohort was 46 years ( range , 20-65 years ) ; 61 % were females , 49 % were smokers , 30 % had primary diagnosis of isthmic spondylolisthesis , 35 % had disc degeneration and no previous surgery , and 35 % had disc degeneration and previous surgery .\
METHODS	Eighty-two percent of patients have had symptoms for more than 2 years and 50 % were out of the labor market due to sickness .\
METHODS	The EQ-5D instrument was applied for the measurement of health-related quality of life and costs ( 2004 U.S. dollars ) were measured in a full-scale societal perspective .\
METHODS	Productivity costs were valued by the Friction Cost method , and both costs and effects were discounted .\
METHODS	Arithmetic means and 95 % bias-corrected , bootstrapped confidence intervals were reported .\
METHODS	Nonparametric statistics were used for tests of statistical significance .\
METHODS	Comprehensive sensitivity analysis was conducted and reported using cost-effectiveness acceptability curves .\
RESULTS	The circumferential group demonstrated clinical superiority over the posterolateral fusion group in functional outcome ( P < 0.01 ) , fusion rate ( P < 0.04 ) , and number of reoperations ( P < 0.01 ) among others .\
RESULTS	Cost-utility analysis demonstrated circumferential fusion dominant over posterolateral fusion , that is , for each QALY gained performing circumferential fusion , the incremental saving was estimated at U.S. $ 49,306 ( 95 % confidence interval , $ 27,183 - $ 2,735,712 ) .\
RESULTS	Results proved to be strong to various sensitivity analyses ; only a differentiated underestimation of patients ' need for postoperative household help against the circumferential approach could alter the dominance ; however , still the probability of cost-effectiveness was > 0.85 given a threshold for willingness to pay of U.S. $ 50,000 per QALY .\
CONCLUSIONS	Circumferential fusion is dominant over instrumented posterolateral fusion , that is , both being significantly cheaper and significantly better in a long-term , societal perspective .\
\
###20435966\
BACKGROUND	Transference-focused psychotherapy is a manualised treatment for borderline personality disorder .\
OBJECTIVE	To compare transference-focused psychotherapy with treatment by experienced community psychotherapists .\
METHODS	In a randomised controlled trial ( NCT00714311 ) 104 female out-patients were treated for 1 year with either transference-focused psychotherapy or by an experienced community psychotherapist .\
RESULTS	Significantly fewer participants dropped out of the transference-focused psychotherapy group ( 38.5 % v. 67.3 % ) and also significantly fewer attempted suicide ( d = 0.8 , P = 0.009 ) .\
RESULTS	Transference-focused psychotherapy was significantly superior in the domains of borderline symptomatology ( d = 1.6 , P = 0.001 ) , psychosocial functioning ( d = 1.0 , P = 0.002 ) , personality organisation ( d = 1.0 , P = 0.001 ) and psychiatric in-patient admissions ( d = 0.5 , P = 0.001 ) .\
RESULTS	Both groups improved significantly in the domains of depression and anxiety and the transference-focused psychotherapy group in general psychopathology , all without significant group differences ( d = 0.3-0 .5 ) .\
RESULTS	Self-harming behaviour did not change in either group .\
CONCLUSIONS	Transference-focused psychotherapy is more efficacious than treatment by experienced community psychotherapists in the domains of borderline symptomatology , psychosocial functioning , and personality organisation .\
CONCLUSIONS	Moreover , there is preliminary evidence for a superiority in the reduction of suicidality and need for psychiatric in-patient treatment .\
\
###11092464\
OBJECTIVE	Bisphosphonates are potent inhibitors of osteoclastic activity and are used in the treatment of multiple myeloma ( MM ) in combination with chemotherapy .\
OBJECTIVE	The effect of pamidronate on markers of bone resorption [ cross-linked N-telopeptides of type I collagen ( NTx ) ] , markers of bone formation [ serum alkaline phosphatase ( BAP ) and osteocalcin ( OSC ) ] , interleukin-6 ( IL-6 ) , beta2-microglobulin , CRP , paraprotein and disease-related pain and skeletal events has been evaluated in 62 newly diagnosed patients with MM .\
METHODS	The patients were randomly assigned to two groups : the first included 32 patients under chemotherapy and pamidronate ( group I ) and the second 30 patients on chemotherapy only ( group II ) .\
METHODS	Pamidronate was administered at a monthly dose of 90 mg iv , and the above parameters were evaluated at the beginning of this study and after 1 , 3 , 6 , 9 , 12 and 14 months of treatment .\
RESULTS	The addition of pamidronate to chemotherapy resulted in a significant reduction of NTx , IL-6 and paraprotein from the 3rd month and of beta2-microglobulin , CRP and pain from the 6th month of treatment .\
RESULTS	No changes of NTx , IL-6 , beta2-microglobulin , CRP or skeletal events were observed in patients of group II , while paraprotein was significantly reduced after 6 months of treatment .\
RESULTS	The differences in NTx , IL-6 , paraprotein and beta2-microglobulin were statistically significant between the two groups .\
RESULTS	Multivariate analysis revealed a significant correlation between changes of NTx , changes of IL-6 in both groups and reduction of pain and paraprotein in group I.\
CONCLUSIONS	These results suggest that pamidronate may have a synergistic action with chemotherapy in decreasing osteoclastic activity , in reducing markers of myeloma activity and myeloma related pain and in improving the quality of life in patients with MM .\
\
###22236804\
BACKGROUND	Omalizumab may inhibit allergic inflammation and could contribute to decreasing airway remodeling in patients with asthma .\
OBJECTIVE	The aim of this study was to assess the effects of omalizumab on airway wall thickness using computed tomography ( CT ) .\
METHODS	Thirty patients with severe persistent asthma were randomized to conventional therapy with ( n = 14 ) or without omalizumab ( n = 16 ) for 16 weeks .\
METHODS	The following airway dimensions were assessed by a validated CT technique : airway wall area corrected for body surface area ( WA/BSA ) , percentage wall area ( WA % ) , wall thickness ( T ) / BSA , and luminal area ( Ai ) / BSA at the right apical segmental bronchus .\
METHODS	The percentage of eosinophils in induced sputum , pulmonary function and the Asthma Quality of Life Questionnaire ( AQLQ ) were assessed as well .\
RESULTS	Treatment with omalizumab significantly decreased WA/BSA ( p < 0.01 ) , WA % ( p < 0.01 ) , and T/BSA ( p < 0.01 ) , and increased Ai/BSA ( p < 0.05 ) , whereas conventional therapy resulted in no change .\
RESULTS	In the omalizumab group ( n = 14 ) , a significant decrease in the percentage of sputum eosinophils ( p < 0.01 ) , improved forced expiratory volume in 1 s ( FEV ( 1 ) ) , and an improved AQLQ score were recorded .\
RESULTS	The changes in FEV ( 1 ) % predicted and sputum eosinophils were significantly correlated with changes in WA % ( r = 0.88 , p < 0.001 , and r = 072 , p < 0.01 , respectively ) .\
CONCLUSIONS	These findings suggest that omalizumab reduced airway wall thickness and airway inflammation .\
CONCLUSIONS	Larger patient studies with longer-term follow-up are needed to show whether omalizumab can truly maintain improved airway wall dimensions .\
\
###17099376\
OBJECTIVE	To study the effectiveness of local antiseptic spray with or without a three-dose antibiotic regimen in the prevention of stomal infection following percutaneous endoscopic gastrostomy .\
METHODS	Ninety-six patients were randomized into three groups : A , intravenous cefuroxime 750 mg just before the procedure followed by two further doses every 8 h ; B , single application of povidone-iodine ( Betadine ) antiseptic spray ; C , combination of A and B.\
METHODS	The stomal site was examined at midweek and at the end of week 1 for evidence of infection using a validated scoring system .\
METHODS	Fisher 's exact test was used for analysis of primary end point , namely , stomal infection at midweek and at the end of week 1 .\
METHODS	Logistic regression models were used for secondary analysis to consider the effects of diabetes , acid suppressants , steroids , age and sex on outcome .\
RESULTS	Group A had 34 patients , group B had 28 and group C had 34 .\
RESULTS	Age , sex and indications in groups A , B and C are broadly comparable .\
RESULTS	Stomal infection was 32 % in group B vs. groups A ( 6 % ) and C ( 9 % ) ( P = 0.0114 ) at midweek , and 3 % in group C vs. 32 % each in groups A and B ( P = 0.0013 ) at the end of week 1 .\
RESULTS	Cumulative infections ( n ) at the end of week 1 were lower in group C ( 3 ) ( 9 % ) than in groups A ( 11 ) ( 32 % ) and B ( 12 ) ( 43 % ) ( P = 0.003 ) .\
RESULTS	No significant difference was observed between the three groups in terms of the number of patients who were given antibiotics for other indications ( P = 0.363 ) .\
RESULTS	By logistic regression only diabetes , but not other covariates , seems to have a significant effect on stomal infection ( odds ratio , 33.34 ; 95 % CI , 4.33-256 .7 ) .\
CONCLUSIONS	A combination of cefuroxime and Betadine spray significantly reduces stomal infection following percutaneous endoscopic gastrostomy at the end of week 1 .\
CONCLUSIONS	Both the antibiotic group ( A ) and the combined group ( C ) did well compared with the Betadine only group ( B ) at midweek .\
\
###20138720\
OBJECTIVE	The efficacy of levocabastine nasal spray for relieving the symptoms of perennial allergic rhinitis was compared with placebo in a single-blind study .\
METHODS	Three hundred and thirty-five patients with moderate to severe perennial allergic rhinitis were randomized to three groups that were administered a high or low dose of levocabastine nasal spray or a placebo .\
METHODS	Patients were not informed of their treatment .\
METHODS	Efficacy was evaluated based on the changes of symptoms and rhinoscopy findings .\
RESULTS	Significant improvement of symptoms was observed in both the high-dose and low-dose levocabastine groups compared with the placebo group .\
RESULTS	There were no significant differences of efficacy between the high-dose and low-dose levocabastine groups .\
RESULTS	There was also no significant difference in the occurrence of adverse effects among the three groups .\
CONCLUSIONS	Levocabastine nasal spray is a safe and effective treatment for perennial allergic rhinitis .\
\
###17298307\
OBJECTIVE	To determine the need for suction drainage after elective thyroid and parathyroid surgery .\
METHODS	Randomised controlled trial .\
METHODS	University teaching hospital .\
METHODS	Patients requiring elective thyroid or parathyroid surgery were recruited and informed consent was obtained ( n = 100 ) .\
METHODS	Before wound closure , patients were randomised into either group A ( to remain without suction drainage ) or group B ( to receive suction drainage ) .\
METHODS	Excluded patients were those requiring associated neck dissection and those with bleeding diatheses , all of whom would necessarily require drainage in our unit .\
METHODS	Primary - ultrasound evaluation of any collection in the thyroid bed , performed 1-day postoperatively .\
METHODS	Secondary - postoperative complications ; length of in-patient stay .\
RESULTS	One hundred patients completed the study , and groups A and B comprised 50 patients each .\
RESULTS	Patients in each group exhibited a mean age of 49 years , and a male to female ratio of 1 : 9 .\
RESULTS	Both groups were also well-matched regarding type of operation , size of tumour and histopathological diagnosis .\
RESULTS	Modal and median postoperative neck collection volume on ultrasound examination was 0 and 0 cm ( 3 ) respectively ( range 0-16 cm ( 3 ) ) in group A and was 0 and 0 cm ( 3 ) ( range 0-70 cm ( 3 ) ) in group B.\
RESULTS	This difference was not statistically significant , but three patients with a haematoma were all in the suction drainage group .\
RESULTS	Difference in complication rates between groups was also not statistically significant .\
RESULTS	Modal and median length of in-patient stay was 2 and 2 days respectively ( range 2-3 days ) in group A and 3 and 3 days ( range 2-4 days ) in group B , and this difference was statistically significant ( P = 0.0006 ) .\
CONCLUSIONS	Routine suction drainage after uncomplicated elective thyroid and parathyroid surgery appears unnecessary , and prolongs in-patient stay .\
\
###8740786\
BACKGROUND	Both chemotherapy and tamoxifen are widely used either alone or in combination as adjuvant treatment following mastectomy .\
BACKGROUND	Despite the fact that both of them exhibit carcinogenic properties in experimental models , detailed reports on the incidence of new primaries following chemotherapy and/or tamoxifen in patients with early breast cancer are limited .\
OBJECTIVE	To investigate the incidence of new primaries ( including opposite breast tumors and skin cancers ) in untreated patients and in patients treated with either tamoxifen or chemotherapy or with both modalities .\
METHODS	A total of 1696 patients with early breast cancer , 1286 of whom were treated with either CMF-based adjuvant chemotherapy ( n = 410 ) , tamoxifen ( n = 656 ) or with a combination of the two ( n = 220 ) were considered for the present analysis .\
METHODS	Patients were operated on between November 1983 and December 1991 and were followed up to June 1994 .\
METHODS	Detailed information about second malignancies were available for all patients .\
RESULTS	Overall , 53 new primaries , 19 of them opposite breast tumors , occurred in 53 patients .\
RESULTS	The actuarial cumulative incidence rates at 5 years were : 3.1 % ( 95 % CI : 1.4 % -4.8 % ) in untreated patients ; 1.7 % ( 95 % CI : 0.0 % -3.5 % ) in tamoxifen-treated patients ; 4.2 % ( 95 % CI : 1.3 % -7.1 % ) in chemotherapy-treated patients and 2.6 % ( 95 % CI : 0.0 % -5.2 % ) in the chemo-tamoxifen group ( all groups : P = n.s. ; chemotherapy-treated versus tamoxifen-treated : P = 0.01 ) .\
RESULTS	The corresponding figures , after exclusion of the patients with opposite-breast and skin tumors , were : untreated patients : 2 % ( 95 % CI : 0.6 % -3.4 % ) ; tamoxifen-treated patients : 0.95 % ( 95 % CI : 0.0 % -2.4 % ) ; chemotherapy-treated patients : 2.6 % ( 95 % CI : 0.4 % -4.8 % ) ; chemotherapy plus tamoxifen : 1.65 % ( 95 % CI : 0.4 % -3.8 % ) ; ( all groups : P = n.s. ; CT versus TAM P = 0.05 ) .\
RESULTS	Chemotherapy-treated patients showed a risk that was about two-fold that of the one to be expected in the general population .\
RESULTS	By contrast , a decrease in the total risk was observed in patients treated with tamoxifen .\
RESULTS	Patients who received chemotherapy and tamoxifen as well as those in the no-treatment group showed a risk which was comparable to that of the general population .\
CONCLUSIONS	Adjuvant chemotherapy appears to increase the risk of second malignancies .\
CONCLUSIONS	By contrast , tamoxifen seems to exert an overall protective effect in this regard , and it also appears to counteract , at least partially , the carcinogenic effect of chemotherapy .\
CONCLUSIONS	While there is plenty of evidence that the benefit achieved by adjuvant chemotherapy considerably exceeds the risk of second malignancies , the indiscriminate use of chemotherapy should be avoided , particularly in patients with a low risk of relapse .\
CONCLUSIONS	Moreover , it seems reasonable to prefer tamoxifen over chemotherapy for patients likely to obtain comparable therapeutic benefit from antiestrogenic treatment .\
\
###16399173\
OBJECTIVE	Compare two dosage strengths of levofloxacin in the treatment of acute bacterial sinusitis .\
METHODS	Multicenter clinical trial comparing levofloxacin 750 mg for 5 days vs levofloxacin 500 mg for 10 days .\
RESULTS	Sinus fluid samples were obtained by antral puncture ( 59.2 % ) or by sinus endoscopy ( 40.8 % ) .\
RESULTS	Among microbiologically evaluable patients , 91.4 % ( 139/152 ) of patients receiving levofloxacin 750 mg achieved clinical success vs 88.6 % ( 132/149 ) of patients receiving levofloxacin 500 mg ( 95 % CI -10.0 , 4.2 ) .\
RESULTS	Clinical success rates by pathogen were above 90 % in both treatment groups for the 3 typical pathogens of acute sinusitis : Streptococcus pneumoniae , Haemophilus influenzae , and Moraxella catarrhalis .\
RESULTS	The safety profile of the 2 dosage strengths was similar .\
CONCLUSIONS	Levofloxacin 750 mg for 5 days is noninferior to levofloxacin 500 mg for 10 days .\
CONCLUSIONS	Levofloxacin 750 mg for 5 days represents a safe and effective treatment regimen for acute bacterial sinusitis .\
METHODS	A-1b .\
\
###14571614\
OBJECTIVE	To study the therapeutic effect of Luohuo Capsule ( LHC ) clinically .\
METHODS	Clinical trial on 90 patients were carried out adopting randomized , stratified , single-blinded and positive drug controlled method , by divided patients into the treated group ( n = 60 ) and the control group ( n = 30 ) .\
METHODS	The treated group was treated with LHC , which was mainly consisted of Leech , Radish seed , Water-plantain Tuber , Chuanxiong , etc. .\
METHODS	The control group was treated with Beijing Hypotensive .\
METHODS	No. 0 .\
METHODS	The therapeutic course was 4 weeks .\
METHODS	The diagnosis and efficacy evaluation were in accord with corresponding national standards , using the indexes including safety , clinical symptoms , blood pressure , hemorrheologic parameters , blood lipid , adrenal medullin ( AdM ) and plasma tissue factor pathway inhibitor ( TFPI ) .\
RESULTS	The total effective rate of LHC in lowering blood pressure in the treated group and the control group was 85.00 % and 86.67 % respectively , comparison of them showed no significant difference ( P = 0.915 ) .\
RESULTS	Most of the improvement of clinical symptoms in the treated group were better than those in the control group ( P < 0.05 or P < 0.01 ) .\
RESULTS	LHC could also improve the hemorrheologic status ( P < 0.01 ) , alleviate the blood lipids disorder ( P < 0.05 ) , and adjust AdM and TFPI ( P < 0.05 ) .\
CONCLUSIONS	LHC is safe in treating hypertension grade I and II with no adverse reaction .\
\
###21565344\
BACKGROUND	While waiting for surgery , patients often exhibit fear and anxiety .\
BACKGROUND	Music is thought to be an alternative to medication to relieve anxiety .\
BACKGROUND	However , due to concerns about infection control , devices other than headphones may be considered for this purpose .\
OBJECTIVE	The purpose of this study was to determine the anxiety-relieving effect of broadcast versus headphone music playing for patients awaiting surgery .\
METHODS	A randomized controlled clinical study .\
METHODS	The waiting area of an operating theater of a metropolitan teach hospital in Taiwan .\
METHODS	Alert adult with age between 20 and 65 years old waiting for surgery without premedications .\
METHODS	A total of 167 patients were randomly assigned to the headphone , broadcast and control groups .\
METHODS	Both the headphone and the broadcast groups were provided with the same instrumental music , while the control group did not listen to any music .\
METHODS	The tools for measuring anxiety were visual analogue scale ( VAS ) ranging from `` not anxious at all '' to `` extremely anxious '' and heart rate variability ( HRV ) .\
RESULTS	The VAS score exhibited a significant decrease for both the headphone and broadcast groups .\
RESULTS	The low frequency and low-to-high frequency LF/HF ratio of the broadcast and headphone groups were significantly lower than those of the control group .\
RESULTS	None of the heart rate variables showed significant differences between the broadcast group and the headphone group .\
CONCLUSIONS	Both headphone and broadcast music are effective for reducing the preoperative patient 's anxiety in the waiting room .\
CONCLUSIONS	In order to take infection control into account , broadcast speakers can substitute for headphones for playing music to lower the anxiety level of patients waiting for surgery .\
\
###11815967\
BACKGROUND	This was a prospective randomized clinical trial undertaken at our institution to compare low-dose-rate ( LDR ) intracavitary radiation therapy versus high-dose-rate ( HDR ) intracavitary radiation therapy for the treatment of cervical carcinoma .\
METHODS	From January 1984 to December 1997 , a total of 132 patients with Stage II or IIIB of invasive carcinoma of the uterine cervix were entered into this randomized study .\
METHODS	Treatment arm by HDR or LDR was allocated according to the month of each patient 's birth .\
METHODS	External irradiation consisted of whole pelvis irradiation and pelvic irradiation .\
METHODS	Doses of external irradiation for both groups were identical .\
METHODS	The authors used 0.588 as the conversion factor of total intracavitary dose from LDR to HDR .\
RESULTS	The 5-year disease specific survival rates of Stage II and III patients treated with HDR were 69 % and 51 % whereas those with LDR were 87 % and 60 % , respectively .\
RESULTS	The 5-year pelvic recurrence free survival rates of Stage II and III patients treated with HDR were 89 % and 73 % whereas those with LDR were 100 % and 70 % , respectively .\
RESULTS	There was no significant difference in disease specific survival or pelvic recurrence free survival rates between HDR and LDR .\
RESULTS	The actuarial complication rate ( Radiation Therapy Oncology Group Grade 3 , 4 , or 5 ) at 5 years was 10 % in the HDR group and 13 % in the LDR group , and the difference between the HDR and LDR groups was not statistically significant .\
CONCLUSIONS	The pelvic control or actuarial complication rates were comparable between HDR and LDR treatment .\
CONCLUSIONS	The difference between the disease specific survival rates for HDR and LDR was not statistically significant for Stage II or III , although in Stage II , patients treated with LDR appeared to have a better survival rate than those treated with HDR .\
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###8989179\
OBJECTIVE	To investigate the influence of the neuromuscular blocking agent vecuronium on oxygen delivery ( DO2 ) , oxygen consumption ( VO2 ) , oxygen extraction ratio , and gastric intramucosal pH in heavily sedated patients with severe sepsis or septic shock .\
METHODS	Prospective , randomized , placebo-controlled , cross-over trial .\
METHODS	University hospital intensive care unit .\
METHODS	Eighteen mechanically ventilated patients with severe sepsis or septic shock .\
METHODS	All patients were heavily sedated .\
METHODS	After baseline measurement , a computer-controlled , closed-loop infusion of either vecuronium or saline was initiated and further measurements were made at 40 and 60 mins .\
METHODS	The procedure was repeated with the alternative agent after return of neuromuscular function .\
RESULTS	DO2 , VO2 , intramucosal pH were monitored using pulmonary artery catheters , a gas exchange monitor , and gastric tonometers .\
RESULTS	Changes from baseline were compared ( paired t-test , p = .05 ) .\
RESULTS	The vecuronium closed-loop infusion achieved T1 between 5 % and 15 % at 40 mins .\
RESULTS	There was a significant difference in the changes from baseline for static respiratory compliance in the vecuronium closed-loop infusion group compared with the saline closed-loop infusion group .\
RESULTS	There was no significant difference in the change from baseline for systemic or pulmonary vascular resistance , DO2 , VO2 , oxygen extraction ratio , or intramucosal pH.\
CONCLUSIONS	In these patients , vecuronium infusion achieved the targeted level of paralysis and improved respiratory compliance but did not alter intramucosal pH , VO2 , DO2 , or oxygen extraction ratios .\
CONCLUSIONS	With deep sedation , neuromuscular blockade in severe sepsis/septic shock does not significantly influence oxygen flux and should be abandoned as a routine method of improving tissue oxygenation in these patients .\
\
###18065019\
OBJECTIVE	To identify the optimal dressing for split-thickness skin graft ( SSG ) donor sites .\
METHODS	This prospective randomised controlled trial compared two dressings - a new absorbent form of a polyurethane film dressing ( Tegaderm Absorbent , 3M ) and our standard alginate dressing ( Kaltostat , ConvaTec ) - on SSG donor sites in 40 patients .\
METHODS	Primary outcome measures were : reduced time to full healing ; reduced postoperative pain ; reduced leakage rates from the dressing .\
METHODS	Secondary outcome measures related to acceptability of the dressings to the patient .\
RESULTS	On removal of the dressings at the first assessment , 79 % of the Tegaderm Absorbent donor sites had healed completely , compared with 16 % of the Kaltostat ones ( p < 0.001 ) .\
RESULTS	A significantly greater median area had healed with Tegaderm Absorbent ( 100 % ) , when compared with Kaltostat ( 89 % ) ( p < 0.001 ) .\
RESULTS	Mean time to complete healing was also significantly faster for Tegaderm Absorbent than Kaltostat ( 14 versus 21 days ) ( p < 0.001 ) .\
RESULTS	Significantly fewer subjects experienced postoperative pain with Tegaderm Absorbent on both day 1 ( 21 % versus 67 % , p = 0.006 , NNT = 3 ) and day 2 ( 17 % versus 75 % , p < 0.001 , NNT = 2 ) .\
RESULTS	Leakage rates reduced by 48 % with Tegaderm Absorbent , with no leakage in the smaller donor sites .\
RESULTS	Tegaderm Absorbent was significantly easier to apply than Kaltostat ( 89 % versus 27 % found it ` very easy ' ) as was ease of removal ( 84 % versus 11 % found it ` very easy ' ) ( p < 0.0001 ) .\
RESULTS	Patients found Tegaderm Absorbent dressings significantly more convenient to manage and bathe with .\
RESULTS	At one month post-surgery , Vancouver scar scores showed thatTegaderm Absorbent donor sites were less red , flatter , softer and less itchy .\
CONCLUSIONS	Tegaderm Absorbent provides a significant improvement in terms of donor-site pain , healing and ease of management .\
\
###14677160\
OBJECTIVE	A prospective , double-blind , randomized , and controlled trial was conducted in patients with knee osteoarthritis ( OA ) to evaluate the efficacy of infrared low-power Gallium-Arsenide ( Ga-As ) laser therapy ( LPLT ) and compared two different laser therapy regimes .\
METHODS	Ninety patients were randomly assigned to three treatment groups by one of the nontreating authors by drawing 1 of 90 envelopes labeled ` A ' ( Group I : actual LPLT consisted of 5 minutes , 3 J total dose + exercise ; 30 patients ) , ` B ' ( Group II : actual LPLT consisted of 3 minutes , 2 J total dose + exercise ; 30 patients ) , and ` C ' ( Group III : placebo laser group + exercise ; 30 patients ) .\
METHODS	All patients received a total of 10 treatments , and exercise therapy program was continued during study ( 14 weeks ) .\
METHODS	Subjects , physician , and data analysts were unaware of the code for active or placebo laser until the data analysis was complete .\
METHODS	All patients were evaluated with respect to pain , degree of active knee flexion , duration of morning stiffness , painless walking distance and duration , and the Western Ontario and Mc Master Universities Osteoarthritis Index ( WOMAC ) at week 0 , 6 , 10 , and 14 .\
RESULTS	Statistically significant improvements were indicated in respect to all parameters such as pain , function , and quality of life ( QoL ) measures in the post-therapy period compared to pre-therapy in both active laser groups ( P < 0.01 ) .\
RESULTS	Improvements in all parameters of the Group I and in parameters , such as pain and WOMAC of the Group II , were more statistically significant when compared with placebo laser group ( P < 0.05 ) .\
CONCLUSIONS	Our study demonstrated that applications of LPLT in different dose and duration have not affected results and both therapy regimes were a safe and effective method in treatment of knee OA .\
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###22919307\
OBJECTIVE	To elucidate whether consumption of two Chinese liquors , tea-flavor liquor ( TFL ) and traditional Chinese liquor ( TCL ) have protective effects on cardiovascular disease ( CVD ) risk factors in healthy human subjects .\
METHODS	Forty-five healthy subjects ( 23 men , 22 women ) , aged 23-28 , were recruited and randomized into two groups : TFL and TCL , and consumed 30 mL/day ( 45 % ( v/v ) alcohol ) of either liquor for 28 days .\
RESULTS	Serum high-density lipoprotein cholesterol/low-density lipoprotein cholesterol ( HDL-C/LDL-C ) and apolipoprotein A1 were significantly increased , and total cholesterol ( TC ) and TC/HDL-C were significantly decreased after the intervention in both groups ( P < 0.05 ) .\
RESULTS	Serum uric acid ( P = 0.004 for TFL , P = 0.001 for TCL ) , glucose ( P < 0.001 for TFL , P < 0.001 for TCL ) and endothelial adhesion molecules ( P < 0.05 ) were significantly decreased after the intervention .\
RESULTS	ADP-induced whole blood platelet aggregation was also significantly decreased after the intervention in both TFL and TCL groups ( P < 0.05 ) .\
CONCLUSIONS	TFL and TCL consumption had protective effects on CVD risk factors in young humans .\
CONCLUSIONS	However , the results were valid only for 28 days , and that the possibility of adverse effect ( liver , kidney ) of chronic alcohol consumption should be considered .\
\
###24314204\
BACKGROUND	Employing waiting list control designs in psychological and behavioral intervention research may artificially inflate intervention effect estimates .\
BACKGROUND	This exploratory randomized controlled trial tested this proposition in a study employing a brief intervention for problem drinkers , one domain of research in which waiting list control designs are used .\
METHODS	All participants ( N = 185 ) were provided with brief personalized feedback intervention materials after being randomly allocated either to be told that they were in the intervention condition and that this was the intervention or to be told that they were in the waiting list control condition and that they would receive access to the intervention in four weeks with this information provided in the meantime .\
RESULTS	A total of 157 participants ( 85 % ) were followed-up after 4weeks .\
RESULTS	Between-group differences were found in one of four outcomes ( proportion within safe drinking guidelines ) .\
RESULTS	An interaction was identified between experimental manipulation and stage of change at study entry such that participant change was arrested among those more ready to change and told they were on the waiting list .\
CONCLUSIONS	Trials with waiting list control conditions may overestimate treatment effects , though the extent of any such bias appears likely to vary between study populations .\
CONCLUSIONS	Arguably they should only be used where this threat to valid inference has been carefully assessed .\
\
###15610836\
OBJECTIVE	To investigate the adequate infusion dose regimen of midazolam to induce sedation with the Ramsay score 4 with rapid onset during combined spinal and epidural anesthesia\
METHODS	Prospective , randomized study .\
METHODS	Operating room of a university hospital .\
METHODS	80 ASA physical status I and II patients aged 30 to 70 years , undergoing combined spinal and epidural anesthesia .\
METHODS	Patients were randomized to four groups of 20 patients each at random .\
METHODS	After starting surgery , an infusion of midazolam 0.3 , 0.6 , 0.9 , or 1.2 mg/kg/hr was started .\
METHODS	When patients closed their eyes spontaneously , the infusion dose was decreased to one half of the initial dose .\
METHODS	At 2.5 and 5 minutes after decrease the dose and at 5-minute intervals for the first 30 minutes then at 15-minute intervals thereafter until the end of surgery , infusion dose was adjusted by decreasing to one half or increasing to twice to keep the Ramsay score 4 .\
RESULTS	The number of patients who required oxygen was significantly larger in the groups received 0.9 and 1.2 mg/kg/hr .\
RESULTS	Eleven patients with 0.9 mg/kg/hr and 17 patients with 1.2 mg/kg/hr at 5 minutes , but no patients with 0.3 or 0.6 mg/kg/hr showed Ramsay score 6 ( heavy sedation ) .\
RESULTS	Amnesia was observed in all patients .\
RESULTS	Time to eye closure was dose dependently faster with the larger doses .\
CONCLUSIONS	During combined spinal and epidural anesthesia , midazolam 0.6 mg/kg/hr given until closing of the eyes ( for 1.6 min ) followed by midazolam 0.15 mg/kg/hr provides rapidly induced sedation , with a Ramsay score of 4 and amnesia with stable hemodynamics and respiration .\
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###14616430\
OBJECTIVE	Breakthrough bleeding or even unwanted pregnancies have been reported in women during concomitant therapy with oral contraceptives and St John 's wort extract .\
OBJECTIVE	The aim of the present study was to investigate the effects of St John 's wort extract on oral contraceptive therapy with respect to ovarian activity , breakthrough bleeding episodes and the pharmacokinetics of ethinyloestradiol and 3-ketodesogestrel .\
METHODS	Eighteen healthy females were treated with a low-dose oral contraceptive ( 0.02 mg ethinyloestradiol , 0.150 mg desogestrel ) alone ( control cycle ) or combined with 300 mg St John 's wort extract given twice daily ( cycle A ) or three times daily ( cycle B ) .\
METHODS	Ovarian activity was assessed by measuring follicle maturation and serum oestradiol and progesterone concentrations .\
METHODS	The number of breakthrough bleeding episodes and the pharmacokinetics of ethinyloestradiol and 3-ketodesogestrel were assessed under steady-state conditions .\
RESULTS	During concomitant administration of low-dose oral contraceptive and St John 's wort , there was no significant change in follicle maturation , serum oestradiol or progesterone concentrations when compared with oral contraceptive treatment alone .\
RESULTS	However , significantly more subjects reported intracyclic bleeding during cycles A ( 13/17 ( 77 % ) , P < 0.015 ) and cycle B ( 15/17 ( 88 % ) , P < 0.001 ) than with oral contraceptives alone ( 6/17 ( 35 % ) ) .\
RESULTS	The AUC ( 0,24 h ) and Cmax of ethinyloestradiol remained unchanged during all study cycles , whereas the AUC ( 0,24 h ) and Cmax of 3-ketodesogestrel decreased significantly from 31.2 ng ml-1 h to 17.7 ng x ml-1 h ( 43.9 % ; 95 % confidence interval ( CI ) -49.3 , -38.5 , P = 0.001 ) and from 3.6 ng x ml -1 to 3.0 ng x ml -1 ( 17.8 % ; CI -29.9 , -5.7 , P = 0.005 ) , respectively , during cycle A and by 41.7 % ( CI -47.9 , -35.6 ; P = 0.001 ) and by 22.8 % ( CI -31.2 , -13.3 ; P < 0.001 ) during cycle B respectively , compared with the control cycle .\
CONCLUSIONS	There was no evidence of ovulation during low-dose oral contraceptive and St John 's wort extract combination therapy , but intracyclic bleeding episodes increased .\
CONCLUSIONS	Bleeding irregularities may adversely effect compliance to oral contraceptives and together with St John 's wort-induced decreases in serum 3-ketodesogestrel concentrations , enhance the risk of unintended pregnancies .\
\
###9423722\
OBJECTIVE	Subfascial division of incompetent perforating veins plays an important role in the surgical treatment of patients with venous ulceration of the lower leg .\
OBJECTIVE	To minimize the high incidence of postoperative wound complications after open exploration , endoscopic approaches have recently been developed .\
OBJECTIVE	We carried out a prospective , randomized comparison of open and endoscopic treatment of these patients that was aimed at ulcer healing and postoperative wound complications .\
METHODS	Patients with current venous ulceration on the medial side of the lower leg were randomly allocated to open exploration by the modified Linton approach or endoscopic exploration by use of a mediastinoscope .\
RESULTS	Thirty-nine patients were randomized , 19 to open exploration and 20 to endoscopic exploration .\
RESULTS	The incidence of wound infections after open exploration was 53 % , compared with 0 % in the endoscopic group ( p < 0.001 ) .\
RESULTS	Patients in the open group needed longer hospital stays ( mean , 7 days ; range , 3 to 39 days ) than patients in the endoscopic group ( mean , 4 days ; range , 2 to 6 days ; p = 0.001 ) .\
RESULTS	Four months after operation , the ulcers of 17 patients ( 90 % ) in the open group and 17 patients ( 85 % ) in the endoscopic group had healed .\
RESULTS	During a mean follow-up of 21 months ( range , 16 to 29 months ) , no recurrences were noticed in either group .\
CONCLUSIONS	Endoscopic division of incompetent perforating veins is equally as effective as open surgical exploration for the treatment of venous ulceration of the lower leg but leads to significantly fewer wound healing complications .\
CONCLUSIONS	Endoscopic division is therefore the preferred method .\
\
###20562609\
OBJECTIVE	In this randomized , controlled , unblinded trial , we sought to test Repeat Back 's ( RB ) effect on comprehension following informed consent discussions .\
BACKGROUND	RB has been suggested as a method to improve patient comprehension when obtaining informed consent .\
BACKGROUND	In this technique , patients are asked to recount what they have been told in the informed consent discussion .\
BACKGROUND	Despite preliminary data , this practice has not been evaluated in any large scale study .\
METHODS	This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent , the VA 's computer based platform .\
METHODS	Patients scheduled for elective surgeries were randomized to RB ( a module added to the iMedConsent package ) or standard iMedConsent ( no RB ) .\
METHODS	Comprehension was tested after the informed consent using procedure-specific questionnaires .\
METHODS	Time stamps in the iMedConsent program estimated the time spent completing the informed consent process .\
METHODS	Provider and patient satisfaction were measured using 5-point Likert scales .\
METHODS	Statistical comparisons of groups were performed using t-tests and chi tests .\
RESULTS	A total of 575 patients were enrolled .\
RESULTS	In the RB group , providers spent 2.6 minutes longer ( P < 0.0001 ) obtaining informed consent .\
RESULTS	The mean comprehension score was significantly higher in the RB group ( 71.4 % ) versus the no RB group ( 68.2 % , P = 0.03 ) ; the effect was greatest in carotid endarterectomy patients ( RB = 73.4 % vs. no RB = 67.7 % , P = 0.02 ) .\
RESULTS	Quality of decision making was rated similarly .\
RESULTS	Providers were neutral to slightly favorable regarding RB .\
CONCLUSIONS	RB implemented within an electronic informed consent system improved patient comprehension .\
CONCLUSIONS	The additional time required was acceptable to providers .\
CONCLUSIONS	RB should be considered as an enhancement to surgical informed consent.This clinical trial was registered at http://www.clinicaltrials.gov ( Identifier NCT00288899 ) .\
\
###12027195\
OBJECTIVE	Postoperative delirium ( POD ) is known to be one of the most critical complications of major operative procedures in elderly patients .\
OBJECTIVE	Since disorders of the sleep-wake cycle have been reported to be one of the key factors in POD , we attempted to clarify the effectiveness of improving sleep-wake cycle disorders with medication after surgery to prevent POD , by conducting a prospective randomized study of 42 elderly patients who underwent resection of either gastric or colon cancer through an open laparotomy .\
METHODS	The delirium-free protocol ( DFP ) group was given an intramuscular injection of diazepam at 20:00 h each night , as well as a continuous intravenous infusion of flunitrazepam and pethidine administered over 8 h , for the first three nights postoperatively .\
METHODS	Two patients were excluded because of failure to complete the DFP .\
RESULTS	The incidence of POD was 7/20 ( 35.0 % ) in the non-DFP group and 1/20 ( 5.0 % ) in the DFP group , this difference being significant ( P = 0.023 ) .\
RESULTS	Morning lethargy produced by the DFP was observed in 40 % of the DFP group ; however , no other side effects were seen .\
CONCLUSIONS	These findings indicate that DFP treatment is effective for controlling POD in elderly patients after general surgery and does not appear to be associated with severe complications or side effects .\
CONCLUSIONS	To our knowledge , this is the first report proposing artificial control of the sleep-awake rhythm by medication as a means of preventing POD in elderly patients .\
\
###25449222\
OBJECTIVE	To evaluate the effect of an intensive early intervention on special service use at school-age .\
METHODS	The Infant Health and Development Program was a randomized controlled trial of an intervention for low birth weight ( < 2500 g ) infants ages 0-3 years .\
METHODS	We used multivariate logistic regression to test the association between intervention and risk of special education , remedial reading and math , and speech therapy at age 8 years .\
METHODS	We also compared rates of service use between study arms among those with learning disabilities ( LDs ) .\
RESULTS	There were 875 complete cases at 8-year follow-up .\
RESULTS	There were no statistically significant differences between groups in risk of special education ( risk ratio [ RR ] 0.86 , 95 % CI 0.64-1 .15 ) , remedial reading ( RR 0.88 , 95 % CI 0.68-1 .14 ) , remedial math ( RR 0.92 , 95 % CI 0.63-1 .34 ) , or speech therapy ( RR 0.87 , 95 % CI 0.62-1 .23 ) .\
RESULTS	The treatment arms did not differ in rates of LDs , and service use for those with LDs was low and unaffected by study group .\
CONCLUSIONS	Early gains in IQ from infant interventions may not protect children as they face the educational demands of grade school .\
CONCLUSIONS	Only a fraction of those having a LD were receiving school-based support services , indicating a high level of unmet need among low birth weight children with disabilities .\
\
###17572615\
METHODS	Cervical corpectomy with preserved posterior vertebral wall ( CPW ) had been performed by the senior author ( Y.W. ) since 1999 .\
METHODS	A prospective study had been conducted to evaluate the efficacy of CPW since 2001 .\
OBJECTIVE	To validate the clinical outcome of CPW against conventional corpectomy ( CC ) .\
BACKGROUND	Anterior surgical managements of cervical spondylotic myelopathy ( CSM ) include discectomy and corpectomy .\
BACKGROUND	Both have significant disadvantages , including low fusion rates and residual symptoms .\
BACKGROUND	A procedure incorporating multilevel discectomy , corpectomy with preserved posterior vertebral wall , autograft and plating was described .\
BACKGROUND	By keeping the posterior vertebral wall ( PW ) , infringement of the vein plexus and spinal canal was avoided and more fusion site was available .\
METHODS	From March 2001 to March 2004 , 178 cases of CSM were randomized to undergo CPW ( n = 89 ) or CC ( n = 89 ) .\
METHODS	Arthrodesis was done with autogenous iliac bone graft or titanium cage supplemented with anterior self-lock plates in both groups .\
METHODS	Operation time , blood loss , days of hospitalization , the numbers and types of complications , and preoperative and postoperative JOA scores were recorded .\
METHODS	Fusion rate , segmental lordosis , and disc height were assessed by roentgenography .\
METHODS	Three-dimensional reconstructions of CT scan were used to confirm fusion evidence .\
RESULTS	Average operation time and blood loss decreased significantly in the CPW group ( 98.06 + / - 19.42 minutes , and 131.69 + / - 62.41 mL ) as compared with those in the CC group ( 108.45 + / - 22.35 minutes , and 181.57 + / - 82.10 mL ) ( P < 0.05 ) .\
RESULTS	There were 2 cases of epidural bleeding and 1 case of CSF leak in the CC group .\
RESULTS	Other complications were minor .\
RESULTS	JOA improvement scores were similar in both groups .\
RESULTS	Roentgenograms showed that the fusion rate was 100 % at 6 months postoperatively in both groups .\
RESULTS	CT scans showed that PW fused with grafts and bone dust in cages .\
RESULTS	Improvement in segmental lordosis and disc height was similar in both groups .\
CONCLUSIONS	CPW is a feasible procedure for anterior decompression and fusion , with safety , complete decompression , and high fusion rate , as long as indicative patients are selected .\
\
###25345840\
OBJECTIVE	The aim of this study was to evaluate the efficacy and safety of intralesional bevacizumab , a monoclonal antibody against vascular endothelial growth factor , in patients with human immunodeficiency virus ( HIV ) - associated Kaposi 's sarcoma of the upper airway receiving antiretroviral therapy .\
METHODS	A pilot randomized , open , phase II study .\
METHODS	HIV-infected patients with Kaposi 's sarcoma lesions of the upper airway in the T0 stage were randomized to receive antiretroviral therapy alone or antiretroviral therapy with intralesional bevacizumab .\
METHODS	The primary end point was the assessment of changes in tumor size according to the Response Evaluation Criteria In Solid Tumors ( RECIST ) ; the secondary end point was safety .\
RESULTS	Of the 14 patients with Kaposi 's sarcoma included in the study , seven were assigned to the bevacizumab group and seven to the control group .\
RESULTS	The median age was 30.5 years ( interquartile range [ IQR ] , 24.7-38 .2 ) .\
RESULTS	Four patients ( 28.5 % ) had > 150 CD4 T cells/mm ( 3 ) .\
RESULTS	Nine patients had lesions in the oral cavity ; three patients had pharyngeal disease ; one patient had laryngeal involvement ; and one patient had oral cavity , pharyngeal , and laryngeal involvement .\
RESULTS	Four patients had complete response ( 28.5 % ) , two had partial response , six had stable disease , and two had progressive disease .\
RESULTS	The median time to complete response was 13 weeks ( IQR , 7.5-36 .5 ) .\
RESULTS	No statistical differences between groups were observed ( P = .124 ) .\
RESULTS	In the bevacizumab group , one patient had a grade I adverse event , and another patient had a grade II adverse event .\
CONCLUSIONS	Intralesional administration of bevacizumab was well tolerated but had no impact on upper respiratory tract Kaposi 's sarcoma lesions of HIV-infected patients .\
\
###23946326\
BACKGROUND	The rate of smokeless tobacco use in India is 20 % ; its use causes serious health problems , and no trial has assessed behavioral or pharmacological treatments for this public health concern .\
BACKGROUND	This trial evaluated varenicline for treating smokeless tobacco dependence in India .\
METHODS	This was a double-blind placebo-controlled randomized trial of varenicline ( 12 weeks , 1mg , twice per day ) with 237 smokeless tobacco users in India .\
METHODS	All participants received behavioral counseling .\
METHODS	Outcomes included self-reported and biochemically verified abstinence at the end of treatment ( EOT ) , lapse and recovery events , safety , and medication adherence .\
RESULTS	Self-reported EOT abstinence was significantly greater for varenicline ( 43 % ) versus placebo ( 31 % ; adjusted odds ratio [ AOR ] = 2.6 , 95 % CI = 1.2-4 .2 , p = .009 ) .\
RESULTS	Biochemically confirmed EOT abstinence was greater for varenicline versus placebo ( 25.2 % vs. 19.5 % ) , but this was not statistically different ( AOR = 1.6 , 95 % CI = 0.84-3 .1 , p = .15 ) .\
RESULTS	Compared with placebo , varenicline did not reduce the risk for a lapse ( hazard ratio [ HR ] = 0.86 , 95 % CI = 0.69-1 .1 , p = .14 ) , but it did increase the likelihood of recovery to abstinence ( HR = 1.2 , 95 % CI = 1.02-1 .4 , p = .02 ) .\
RESULTS	Greater adherence increased EOT cessation rates for varenicline ( 39 % vs. 18 % , p = .003 ) but not for placebo ( 28 % vs. 14 % , p = .06 ) .\
RESULTS	There were no significant differences between varenicline and placebo in rate of side effects , serious adverse events , hypertension , or stopping or reducing medication .\
CONCLUSIONS	Varenicline is safe for treating smokeless tobacco dependence in India , and further examination of this medication for this important public health problem is warranted .\
\
###8662400\
BACKGROUND	The purpose of a prospective randomized study was to compare the surgical trauma in patients undergoing laparoscopic or open hernia repair .\
METHODS	Postoperative pain , analgesic consumption , and metabolic response to surgery were assessed in 30 patients undergoing laparoscopic ( group 1 ; n = 15 ) or open ( group II ; n = 15 ; Shouldice repair ) unilateral inguinal hernia repair .\
METHODS	Both groups were comparable with respect to age , sex , and type and size of inguinal hernia .\
RESULTS	Postoperative visual analogue scales ( VAS ) for pain were reduced on mobilization for patients of group I with a significant difference ( P = 0.02 ) on the operative day , whereas pain scores at rest and analgesic requirements were similar for both groups .\
RESULTS	No differences between groups I and II were found in postoperative levels of interleukin-1 , interleukin-6 , tumor necrosis factor alpha , C-reactive protein , fibrinogen , transferrin , alpha-1-antitrypsin , and white blood cells .\
RESULTS	Postoperative polymorphonuclear ( PMN ) elastase concentrations remained within normal range in group II but showed a significant increase in patients operated laparoscopically for postoperative days 1 and 2 .\
CONCLUSIONS	No major surgical trauma was found after herniorraphy compared to open hernia repair .\
\
###19704072\
BACKGROUND	The National Surgical Adjuvant Breast and Bowel Project B-32 trial was designed to determine whether sentinel lymph node resection can achieve the same therapeutic outcomes as axillary lymph node resection but with fewer side effects and is one of the most carefully controlled and monitored randomized trials in the field of surgical oncology .\
BACKGROUND	We evaluated the relationship of surgeon trial preparation , protocol compliance audit , and technical outcomes .\
METHODS	Preparation for this trial included a protocol manual , a site visit with key participants , an intraoperative session with the surgeon , and prerandomization documentation of protocol compliance .\
METHODS	Training categories included surgeons who submitted material on five prerandomization surgeries and were trained by a core trainer ( category 1 ) or by a site trainer ( category 2 ) .\
METHODS	An expedited group ( category 3 ) included surgeons with extensive experience who submitted material on one prerandomization surgery .\
METHODS	At completion of training , surgeons could accrue patients .\
METHODS	Two hundred twenty-four surgeons enrolled 4994 patients with breast cancer and were audited for 94 specific items in the following four categories : procedural , operative note , pathology report , and data entry .\
METHODS	The relationship of training method ; protocol compliance performance audit ; and the technical outcomes of the sentinel lymph node resection rate , false-negative rate , and number of sentinel lymph nodes removed was determined .\
METHODS	All statistical tests were two-sided .\
RESULTS	The overall sentinel lymph node resection success rate was 96.9 % ( 95 % confidence interval [ CI ] = 96.4 % to 97.4 % ) , and the overall false-negative rate was 9.5 % ( 95 % CI = 7.4 % to 12.0 % ) , with no statistical differences between training methods .\
RESULTS	Overall audit outcomes were excellent in all four categories .\
RESULTS	For all three training groups combined , a statistically significant positive association was observed between surgeons ' average number of procedural errors and their false-negative rate ( rho = +0.188 , P = .021 ) .\
CONCLUSIONS	All three training methods resulted in uniform and high overall sentinel lymph node resection rates .\
CONCLUSIONS	Subgroup analyses identified some variation in false-negative rates that were related to audited outcome performance measures .\
\
###9383487\
OBJECTIVE	To determine whether reducing the speed of injection is effective in reducing injection pain for buffered and unbuffered lidocaine solutions .\
METHODS	A prospective , single-blind , randomized , crossover , laboratory study was performed .\
METHODS	Adult volunteers were recruited from ED staff at an urban teaching hospital to serve as subjects .\
METHODS	Twenty-nine subjects each received 4 1-mL injections into the dorsum of the hands .\
METHODS	Each subject received fast and slow injections of buffered and unbuffered lidocaine .\
METHODS	Subjects rated the pain of each injection on a 100-mm visual analog scale ( VAS ) .\
METHODS	Mean pain scores for each intervention were compared using analysis of variance .\
RESULTS	The mean pain VAS score for fast injection of buffered lidocaine was 14.1 mm .\
RESULTS	For slow buffered injection , the mean pain score was 11.4 mm ( p = 0.98 ) .\
RESULTS	For unbuffered lidocaine , the means were 28.7 mm for fast injection and 22.2 mm for slow injection ( p = 0.40 ) .\
CONCLUSIONS	Reducing injection speed did not produce a statistically significant change in injection pain for either buffered or unbuffered solutions .\
\
###8269790\
OBJECTIVE	To study the association between selected risk factors and the subsequent incidence of type II diabetes over a 5-yr period .\
METHODS	Between 1973 and 1976 , a cohort of men from 22 clinical centers throughout the U.S. enrolled in the Usual Care group of the Multiple Risk Factor Intervention Trial .\
METHODS	The men ( 5420 white , 428 black , 56 Asian , 70 Hispanic , and 26 other ) were nondiabetic at baseline , were in the upper 15 % of risk for coronary heart disease , and had at least two annual follow-up visits for fasting glucose measurements .\
METHODS	The average age was 46 yr and average body mass index was 27.6 kg/m2 .\
METHODS	Incidence of diabetes was defined as use of insulin or hypoglycemic agents , fasting glucose > or = 140 mg/dl on two consecutive annual visits , or fasting glucose > or = 140 mg/dl followed the next year by insulin or hypoglycemic use .\
METHODS	Observations were taken annually over a 5-yr period .\
RESULTS	Cumulative incidence of diabetes over 5 yr was 4.1 % , with 247 incident cases .\
RESULTS	Development of diabetes was directly associated with race ( blacks higher than non-blacks ) , reported parental history of diabetes , and with baseline levels of body mass index , fasting glucose , and glucose 1 h after a 75-g oral glucose load .\
RESULTS	These associations were statistically significant in both univariate and multivariate models .\
RESULTS	A significant interaction was observed between race and reported parental history of diabetes in development of diabetes , particularly within black men who reported a parental history .\
RESULTS	These individuals had higher than expected rates of diabetes development .\
CONCLUSIONS	The data from men in the Usual Care group enrolled in the Multiple Risk Factor Intervention Trial confirm previous findings regarding the associations between the development of diabetes and baseline glucose levels , obesity , race , and parental history of diabetes .\
CONCLUSIONS	The identification of these risk factors provides very powerful tools to identify individuals at high risk of diabetes mellitus who may be amenable to intervention , thereby reducing their risk of developing the disease and its complications .\
\
###15793365\
OBJECTIVE	To assess the clinical utility of phenotypic resistance testing in addition to genotypic resistance testing among HIV-1-infected patients experiencing virologic failure and with limited therapeutic options .\
METHODS	Multicenter randomized trial .\
METHODS	Patients were eligible if a decision had been made to switch antiretroviral therapy , the most recent HIV-1 RNA plasma viral load ( VL ) exceeded 2000 copies/mL , and the clinician was unable to select a potent regimen of 3 or more drugs without access to a resistance test .\
METHODS	Subjects were randomized to genotypic resistance testing alone ( G arm ) or to genotypic plus phenotypic testing ( G + P arm ) .\
METHODS	Patients had access to resistance testing at any time during follow-up ( minimum of 1 year ) according to the original allocation .\
METHODS	The primary end point was change in plasma VL from baseline at 12 months .\
RESULTS	Three hundred eleven patients were recruited between February 2000 and July 2001 .\
RESULTS	At baseline , mean VL and CD4 count were 4.23 log10 copies/mL and 275 cells/mm , respectively , and subjects had previous exposure to a mean of 7.7 antiretroviral drugs .\
RESULTS	There was no appreciable difference between the study arms in the drug regimens prescribed after randomization .\
RESULTS	Mean reduction in VL load at 12 months was similar in the 2 arms ( G : 1.37 log10 reduction , G + P : 1.28 log10 reduction ; P = 0.77 ) , as was the proportion of subjects with VL < 50 copies/mL ( G : 35 % , G + P : 27 % ) .\
CONCLUSIONS	The study did not demonstrate added value of phenotypic resistance testing in conjunction with genotypic resistance testing in patients with limited therapeutic options .\
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###19948382\
BACKGROUND	The present investigation examines baseline patient characteristics to predict dosing of buprenorphine-naloxone , a promising treatment for opioid addiction in youths .\
METHODS	This study of 69 opioid-dependent youths is a secondary analysis of data collected during a National Institute on Drug Abuse ( NIDA ) Clinical Trials Network study .\
METHODS	Outpatients aged 15-21 were randomized to a 12-week buprenorphine-naloxone dosing condition ( including 4 weeks of taper ) .\
METHODS	Predictors of dosing included sociodemographic characteristics ( gender , race , age , and education ) , substance use ( alcohol , cannabis , cocaine , and nicotine use ) , and clinical characteristics ( pain and withdrawal severity ) .\
RESULTS	Most ( 75.4 % ) reported having either `` some '' ( n = 40 , 58.0 % ) or `` extreme '' ( n = 12 , 17.4 % ) pain on enrollment .\
RESULTS	Maximum daily dose of buprenorphine-naloxone ( 19.7 mg ) received by patients reporting `` extreme '' pain at baseline was significantly higher than the dose received by patients reporting `` some '' pain ( 15.0 mg ) and those without pain ( 12.8 mg ) .\
RESULTS	In the adjusted analysis , only severity of pain and withdrawal significantly predicted dose .\
RESULTS	During the dosing period , there were no significant differences in opioid use , as measured by urinalysis , by level of pain .\
CONCLUSIONS	These data suggest that the presence of pain predicts buprenorphine-naloxone dose levels in opioid-dependent youth , and that patients with pain have comparable opioid use outcomes to those without pain , but require higher buprenorphine-naloxone doses .\
\
###19358061\
BACKGROUND	pH-monitoring is considered the gold standard for the detection of acid reflux in patients with non-erosive reflux disease ( NERD ) .\
BACKGROUND	Preliminary pH studies performed over periods longer than 24 hours have shown that in up to one-third of subjects abnormal pH exposure is detected only on the second day of monitoring .\
BACKGROUND	Therefore , pH-monitoring during 48 hours may yield more information about pathological acid reflux in patients being investigated for NERD .\
OBJECTIVE	The aim of this study was to compare conventional 24-hour pH-monitoring with the new wireless 48-hour Bravo pH-monitoring in patients with NERD .\
METHODS	Patients with typical reflux symptoms , a positive reflux disease questionnaire and negative endoscopy ( NERD ) and without any form of acid suppressive therapy were included in this prospective study .\
METHODS	The patients were divided into two groups : group A for conventional 24-hour pH-monitoring and group B for wireless 48-h Bravo pH-monitoring .\
RESULTS	76 patients with a diagnosis of NERD based on a positive RDQ questionnaire and negative endoscopy were included .\
RESULTS	( 47 woman , 29 men , median age : 49 years ) .\
RESULTS	54 underwent conventional pH-monitoring and 22 underwent 48-h pH-monitoring with the new wireless BRAVO system .\
RESULTS	The overall incidence of acid reflux was 55 % in patients with NERD .\
RESULTS	Acid reflux was detected less frequently when using Bravo as compared to conventional pH-monitoring .\
RESULTS	In addition , the Bravo pH-metry showed a large day-to-day variability .\
CONCLUSIONS	Prolonged pH-monitoring over a period longer than 24 hours did not improve the detection of acid reflux in patients with NERD .\
CONCLUSIONS	Thus , it appears that the Bravo pH-metry does not offer an advantage over standard pH-metry in the daily clinical practice .\
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###9529460\
BACKGROUND	At child health visits , immunizations that are due are frequently not given .\
BACKGROUND	Increased parent understanding of and demand for immunizations may influence providers to not miss these opportunities .\
OBJECTIVE	To assess , as part of a larger study of effectiveness of parent education and case management ( CM ) in raising immunization rates , the intervention 's effectiveness at reducing missed opportunities to vaccinate during child health visits .\
METHODS	A representative sample of African American newborns and their families from south central Los Angeles , Calif , were randomly assigned to a control or a CM group and observed during the first year of life .\
METHODS	Case managers visited and telephoned parents , educating them on the benefits and safety of immunizations , and encouraging them to request immunizations from providers .\
METHODS	When the children were at least 1 year of age , parents were interviewed and provider records were abstracted .\
RESULTS	Complete records were abstracted for 126 controls and 129 CM group children .\
RESULTS	For these children , 1092 visits were documented where immunizations were due .\
RESULTS	Missed opportunities to vaccinate occurred at more than 50 % of visits .\
RESULTS	Case management was associated with a modest reduction in the percentage of visits with missed opportunities in the bivariate analysis but not after adjustment for other covariates .\
RESULTS	In a logistic regression model , missed opportunities were more frequent at visits with private than public physicians and at acute illness than well-child visits .\
RESULTS	Missed opportunities were less frequent among children with a history of at least 1 cancelled appointment , and for visits of children with mothers who smoked .\
CONCLUSIONS	Missed opportunities were minimally influenced by a home visitation and parent education program .\
CONCLUSIONS	They are primarily determined by issues under the control of the provider .\
CONCLUSIONS	Family - and child-related characteristics , however , do influence the likelihood of a missed opportunity occurring independent of provider factors .\
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###25265887\
OBJECTIVE	To compare parenterally administered moderate sedation and paracervical block versus general anesthesia during day-case operative hysteroscopy for polypectomy in terms of patients ' postoperative pain perception , operating time , and postoperative drug administration .\
METHODS	A pilot study ( Canadian Task Force classification I ) .\
METHODS	A university hospital .\
METHODS	Women undergoing hysteroscopic polypectomy procedures ( N = 56 ) .\
METHODS	Hysteroscopic polypectomy with general anesthesia or moderate parenteral sedation and paracervical block .\
RESULTS	The patients were divided into 2 groups : 26 underwent general anesthesia ( group 1 ) , and 30 were submitted to moderate parenteral sedation and a paracervical block ( group 2 ) .\
RESULTS	General anesthesia was induced with the laryngeal mask airway with propofol ( 1 % 1-2 .5 mg/kg ) and fentanyl ( 1-2g / kg ) and maintained with an infusion of propofol ( 2 % 3-5mg / kg/h ) .\
RESULTS	After the procedure , patients in the general anesthesia group received postoperative analgesic medication with paracetamol ( 20mg/kg ) and ketorolac ( 0.6 mg/kg ) or tramadol ( 2-3mg / kg ) .\
RESULTS	The group receiving moderate parenterally sedation and a paracervical block received a paracervical block with mepivacaine ( 1 % 10mL ) and lidocaine ( 2 % 10mL ) and received fentanyl ( 1g/kg ) and propofol ( 1 % 1-3mg / kg/h ) maintaining spontaneous breathing .\
RESULTS	A blind observer recorded the operative time and the discomfort of patients using a 4-step scale ( 0-3 ) .\
RESULTS	The postoperative pain assessment was performed 3hours after the procedure with a self-administered validated tool , the Brief Pain Inventory .\
RESULTS	We found that women receiving moderate parenteral sedation and a paracervical block perceived significantly less pain in daily activity ( p < .001 ) , walking ( p < .001 ) , daily work ( p < .001 ) , relations with others ( p = .007 ) , sleep ( p < .001 ) , and pain contrasting enjoyment of life ( p < .001 ) .\
RESULTS	The total amount of time spent in the operating room in group 2 was significantly lower than in group 1 ( p < .014 ) .\
CONCLUSIONS	Moderate sedation plus a paracervical block for operative hysteroscopy is associated with reduced pain perception and a shorter operative time .\
\
###19331224\
BACKGROUND	Erythropoietin corrects and prevents anemia and decreases the need for red blood cell ( RBC ) transfusions ; its impact on quality of life ( QOL ) of cancer patients receiving chemotherapy is not clear .\
METHODS	399 patients with solid tumors and Hb level of < or = 12 g/dl receiving chemotherapy were randomized to receive or not 10,000 IU epoetin-alpha thrice weekly .\
METHODS	QOL was measured by the Functional Assessment of Cancer Therapy-Anemia ( FACT-An ) scale and various subscales at baseline , at two months and at the end of the study .\
RESULTS	Changes in the average QOL scores were similar in the two groups .\
RESULTS	The improvement in Hb levels was significantly higher for the epoetin-alpha group , with a decrease in transfusion requirements compared to the control group .\
CONCLUSIONS	Epoetin-alpha does not improve QOL of patients with solid tumors receiving chemotherapy as assessed using FACT-An scale and various subscales , despite improving Hb levels and reducing transfusion requirements .\
\
###22444242\
OBJECTIVE	Subjective xerostomia is a common side-effect following radiotherapy for the treatment of head-and-neck cancer .\
OBJECTIVE	Standard mean dose models previously used to model xerostomia only that partially predict the occurrence of xerostomia .\
OBJECTIVE	Studies in animal models have suggested that there are regional variations in the radiosensitivity of the parotid glands .\
OBJECTIVE	In this work we tested the hypothesis that this is also true for the human parotid gland .\
METHODS	We present novel dose-response models explicitly taking the spatial distribution of the radiation dose into account .\
METHODS	We considered dose to the submandibular gland and other clinical factors and used a variable-selection algorithm to select the best dose-response model .\
METHODS	This methodology was applied to 63 head and neck cancer patients and validated using two independent patient cohorts of 19 and 29 patients , respectively .\
RESULTS	The predictive accuracy of dose-response models improved significantly when including regional variations of radiosensitivity of the parotid glands compared to standard mean-dose models ( p = 0.001 , t-test ) .\
RESULTS	Beneficial dose-pattern analysis demonstrated the importance of minimising dose to the lateral and cranial component of the human parotid gland in order to avoid xerostomia .\
RESULTS	Furthermore we found an evidence that surgical removal of the sub-mandibular gland significantly increases the risk of radiation-induced xerostomia .\
CONCLUSIONS	Dose-response models which take the shape of the dose-distribution into account predicted xerostomia significantly better than standard mean-dose models .\
CONCLUSIONS	Our novel model could be used to rank potential treatment plans more reliably according to their therapeutic index and may be useful to generate better treatment plans .\
\
###23672632\
OBJECTIVE	To evaluate the efficacy and safety of linagliptin in Chinese patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled by metformin and sulphonylurea .\
METHODS	Data for a pre-defined Chinese subgroup who participated in a Phase III randomised , placebo-controlled , 24 week trial ( NCT00602472 ) were analysed .\
METHODS	The primary endpoint was change in HbA1c from baseline to 24 weeks .\
METHODS	Apart from safety endpoints , secondary endpoints included changes in FPG and measures of insulin secretion and resistance .\
RESULTS	A total of 192 Chinese patients with T2DM participated in the pre-defined analysis ; 144 and 48 patients received linagliptin or placebo , respectively , added to metformin and sulphonylurea .\
RESULTS	Baseline characteristics ( mean [ SD ] ) for linagliptin and placebo were similar : HbA1c : 8.1 % ( 0.85 ) and 8.1 % ( 0.84 ) ; body mass index : 25.9 ( 3.2 ) and 25.6 ( 3.4 ) kg/m , respectively .\
RESULTS	Placebo-corrected mean ( SE ) change in HbA1c from baseline at 24 weeks was -0.68 % ( 0.14 ) with linagliptin-based treatment ( 95 % CI : -0.96 to -0.39 ; P < 0.0001 ) .\
RESULTS	Placebo-corrected mean ( SE ) change in FPG from baseline at 24 weeks with linagliptin was -18.8 ( 6.5 ) mg/dL ( -1.0 [ 0.4 ] mmol/L ; 95 % CI : -31.7 to -5.9 ; P = 0.0044 ) .\
RESULTS	Overall adverse event ( AE ) rates with linagliptin and placebo including background medication were similar ( 38.9 % and 43.8 % , respectively ) .\
RESULTS	Drug-related AEs were reported by 12.5 % and 2.1 % of linagliptin and placebo patients , respectively .\
RESULTS	Differences were due to hypoglycaemia ( 10.4 % and 0.0 % , respectively ) .\
RESULTS	No severe hypoglycaemia was reported in either group of this sub-population .\
CONCLUSIONS	Linagliptin in combination with metformin and sulphonylurea has a favourable safety profile and is an efficacious and well tolerated treatment option for Chinese patients with inadequately controlled T2DM .\
CONCLUSIONS	Reduction of sulphonylurea dose should be considered to minimise risk of hypoglycaemia .\
CONCLUSIONS	Although the findings of this pre-specified sub-analysis may be limited by the number of patients in the subgroup , the results were generally consistent with those for the overall population .\
CONCLUSIONS	CLINICALTRIALS IDENTIFIER : NCT00602472 .\
\
###9925130\
BACKGROUND	An elevated plasma total homocysteine concentration is a risk factor for cardiovascular disease and neural tube defects .\
BACKGROUND	A high daily intake of supplemental folic acid is known to decrease total homocysteine concentrations .\
OBJECTIVE	We studied the effect of low-dose folic acid administration ( 250 or 500 ( microgram/d ) for 4 wk on plasma total homocysteine concentrations and folate status .\
OBJECTIVE	We also investigated whether total homocysteine concentrations and blood folate concentrations returned to baseline after an 8-wk washout period .\
METHODS	In this placebo-controlled study , 144 healthy women aged 18-40 y received 500 microgram folic acid/d , 500 microgram folic acid every second day ( 250 microgram/d ) , or a placebo tablet with their habitual diet ( mean dietary folate intake : 280 microgram/d ) .\
RESULTS	Administration of 250 and 500 microgram folic acid/d for 4 wk significantly increased folate concentrations in plasma ( P < 0.001 ) and red blood cells ( P < 0.01 ) .\
RESULTS	Total homocysteine concentrations decreased significantly ( P < 0.001 ) in women ( n = 50 ) who took 250 microgram folic acid/d [ mean ( + / - SEM ) deviation from baseline : - 11.4 + / - 198 % ] and in women ( n = 45 ) who took 500 microgram folic acid/d ( -21.8 + 1.49 % ) .\
RESULTS	Eight weeks after the end of the intervention period ( week 12 ) , plasma total homocysteine concentrations in the folic acid-supplemented groups had not returned to baseline ( week 0 ) .\
CONCLUSIONS	Doses of folic acid as low as 250 microgram/d , on average , in addition to usual dietary intakes of folate significantly decreased plasma total homocysteine concentrations in healthy , young women .\
CONCLUSIONS	An 8-wk washout period was not sufficient for blood folate and plasma total homocysteine concentrations to return to baseline concentrations .\
\
###9831221\
BACKGROUND	Mepartricin , a semisynthetic polyene derivative with a favorable effect on urethro-prostatic function , was clinically evaluated , adopting the diagnostic and research criteria recommended by the First International Consultation on BPH .\
METHODS	A multicenter , randomized , double-blind , parallel-group study compared mepartricin 40 mg/daily to placebo in the treatment of 196 patients with newly diagnosed BPH and mild-to-moderate symptomatology .\
METHODS	International Prostate Symptom Score ( I-PSS ) , quality of life ( QoL ) index and maximum urinary flow-rate ( Qmax ) were determined every 4 weeks for 6 months ; postvoiding volume , prostate volume , and prostate-specific antigen ( PSA ) were assessed after 3 and 6 months of therapy .\
RESULTS	Mepartricin was shown to determine a statistically significant improvement over placebo in I-PSS and QoL index from month 2 onwards , and a significant linear increase in Qmax over the study period .\
RESULTS	At month 6 , the improvement in the mepartricin and placebo groups in I-PSS , QoL index , and Qmax was 6.3 ( standard error ( SE ) 0.51 ) and 4.2 ( SE 0.60 ) points ( P = 0.003 ) , 0.99 ( SE 0.14 ) and 0.62 ( SE 0.12 ) points ( P = 0.036 ) , and 2.7 ( SE 0.46 ) and 1.2 ( SE 0.46 ) ml/sec ( P = 0.051 ) , respectively .\
RESULTS	No significant differences were noted in postvoiding residual volume , prostate volume , or PSA .\
RESULTS	Mepartricin tolerability was good , showing no adverse events on sexual function .\
CONCLUSIONS	Mepartricin proved to be an effective treatment of benign prostatic hyperplasia , determining an improvement in symptoms , quality of life , and peak urinary flow .\
\
###10472853\
OBJECTIVE	To investigate the incidence of uterine bleeding during 12 months of treatment with 17beta-estradiol ( E2 ) 1 mg , unopposed or in combination with three doses of norethindrone acetate .\
METHODS	This study was a prospective , double-masked , randomized , multicenter trial .\
METHODS	A total of 1176 healthy postmenopausal women age 45 years and older without evidence of endometrial abnormalities were randomly assigned to receive either unopposed E2 1 mg , or continuous-combined formulations of E2 1 mg and norethindrone acetate 0.1 mg , 0.25 mg , or 0.5 mg .\
METHODS	Any spotting or bleeding episodes during the treatment period were recorded in a daily diary and reported by weekly telephone calls .\
RESULTS	The incidence of bleeding was low in the combination groups , even during the initial 3 months of treatment ( 24-28 % ) , after which it decreased with increasing doses of norethindrone acetate .\
RESULTS	Conversely , the incidence of bleeding increased over time with unopposed E2 1 mg .\
RESULTS	After the initial 3 months , the incidence of bleeding among the combination groups was lowest in the norethindrone acetate 0.5 mg group .\
RESULTS	Among women initiating therapy close to menopause , fewer reported bleeding with norethindrone acetate 0.5 mg than with the other combination groups .\
RESULTS	There was a significantly ( P < .05 ) lower discontinuation rate due to bleeding in the norethindrone acetate 0.5 mg group compared with all other treatment groups .\
CONCLUSIONS	Continuous-combined formulations of E2 1 mg with norethindrone acetate 0.1 , 0.25 , or 0.5 mg are associated with a low incidence of uterine bleeding .\
CONCLUSIONS	After the initial 3 months of treatment , bleeding profiles improved with increasing doses of norethindrone acetate .\
\
###15909462\
BACKGROUND	Relief of climacteric symptoms is currently the main role of hormone therapy .\
BACKGROUND	However , vaginal bleeding complicating this therapy is among the leading causes for its early discontinuation .\
OBJECTIVE	To assess the effect of a vaginal ring delivering estradiol and progesterone in postmenopausal women and to determine whether continuous administration can relieve climacteric symptoms , produce an acceptable pattern of vaginal bleeding and control endometrial proliferation .\
METHODS	Twenty-nine postmenopausal women with an intact uterus were studied .\
METHODS	All had climacteric symptoms .\
METHODS	The vaginal rings contained 0.36 g estradiol and either 3.6 g progesterone ( high dose progesterone ) or 1.8 g ( low dose progesterone ) , and were kept in place for 4-6 months .\
METHODS	Serum progesterone , estradiol and estrone were measured and endometrial thickness determined .\
METHODS	All women kept a daily diary of bleeding/spotting and completed a questionnaire on climacteric symptoms at monthly intervals .\
METHODS	The low dose progesterone group comprised 14 women and the high dose progesterone group 15 women .\
RESULTS	A total of 18 patients ( 9 in each group ) completed the study .\
RESULTS	Mean levels of estradiol , estrone and progesterone were at their peak after 2 to 4 weeks .\
RESULTS	All rings were effective in alleviating vasomotor symptoms , although there was evidence of `` escape from effect '' in month 6 .\
RESULTS	Endometrial thickness increased in 6 of the 29 women but biopsy in each case showed no evidence of hyperplasia .\
RESULTS	Of the 18 women who completed the study , 5 had amenorrhea throughout , 7 had amenorrhea after 3 months , and the remainder had one or two bleeding episodes after 3 months .\
RESULTS	Therapy was discontinued in 11 women .\
CONCLUSIONS	A vaginal ring delivering estradiol and progesterone controlled climacteric symptoms , prevented endometrial proliferation , and provided an acceptable bleeding pattern .\
CONCLUSIONS	It should be viewed as a possible alternative for short-term estrogen-progesterone therapy .\
\
###23082784\
OBJECTIVE	The goal of this study was to evaluate the effectiveness of maropitant ( Cerenia ( ) ) in preventing vomiting after premedication with hydromorphone .\
METHODS	Randomized , blinded , prospective clinical study .\
METHODS	Eighteen dogs ASA I/II admitted for elective orthopedic surgical procedures .\
METHODS	The dogs were a mixed population of males and females , purebreds and mixed breeds , 1.0-10 .2 years of age , weighing 3-49 .5 kg .\
METHODS	Dogs were admitted to the study if they were greater than 1 year of age , healthy and scheduled to undergo elective orthopedic surgery .\
METHODS	Dogs were randomly selected to receive one of two treatments administered by subcutaneous injection .\
METHODS	Group M received 1.0 mg kg ( -1 ) of maropitant , Group S received 0.1 mL kg ( -1 ) of saline 1 hour prior to anesthesia premedication .\
METHODS	Dogs were premedicated with 0.1 mg kg ( -1 ) of hydromorphone intramuscularly .\
METHODS	A blinded observer documented the presence of vomiting , retching and/or signs of nausea for 30 minutes after premedication .\
RESULTS	All dogs in S vomited ( 6/9 ) , retched ( 1/9 ) or displayed signs of nausea ( 2/9 ) .\
RESULTS	None ( 0/9 ) of the dogs in M vomited , retched or displayed signs of nausea .\
RESULTS	Dogs in M had significantly fewer incidences of vomiting ( p = 0.0090 ) , vomiting and retching ( p = 0.0023 ) and vomiting , retching and nausea ( p < 0.0001 ) when compared to S.\
CONCLUSIONS	Maropitant prevents vomiting , retching and nausea associated with intramuscular hydromorphone administration in dogs .\
\
###20799005\
BACKGROUND	Health-related quality of life ( HRQOL ) is an important aspect of well-being that may improve with health behavior interventions .\
BACKGROUND	However , health behavior change is difficult with pressure to maintain status quo .\
OBJECTIVE	This report examines the effects of two lifestyle interventions and an advice-only condition on HRQOL .\
OBJECTIVE	Effects of meeting behavioral goals and weight loss also were examined .\
METHODS	Participants were 295 men and 467 women ( 34 % African American ) with pre-hypertension or stage 1 hypertension from the PREMIER trial .\
METHODS	HRQOL was assessed by the Short Form-36 .\
METHODS	Participants were assigned randomly to ( 1 ) advice only ( ADVICE ) , ( 2 ) established guidelines for blood pressure control ( EST ) , or ( 3 ) established guidelines plus the Dietary Approaches to Stop Hypertension ( DASH ) dietary pattern ( EST + DASH ) .\
RESULTS	Assignment to EST resulted in improvement in three HRQOL subscales at 6 months and one at 18 months relative to ADVICE .\
RESULTS	EST + DASH improved in two subscales at 6 and 18 months compared with ADVICE .\
RESULTS	Across conditions , total fat , saturated fat , fruit , and vegetable intake change , along with 4-kg weight loss , resulted in HRQOL improvements at 6 and 18 months .\
RESULTS	No improvement was found for change in physical activity , and only a few HRQOL subscales were associated with change in sodium and low-fat dairy intake .\
CONCLUSIONS	Intensive lifestyle interventions can result in improvements in HRQOL .\
CONCLUSIONS	Change in dietary intake and weight loss is also important .\
\
###11812555\
BACKGROUND	Obstructive sleep apnoea is associated with raised blood pressure .\
BACKGROUND	If blood pressure can be reduced by nasal continuous positive airway pressure ( nCPAP ) , such treatment could reduce risk of cardiovascular disease in patients with obstructive sleep apnoea .\
BACKGROUND	Our aim was to see whether nCPAP for sleep apnoea reduces blood pressure compared with the most robust control intervention subtherapeutic nCPAP .\
METHODS	We did a randomised parallel trial to compare change in blood pressure in 118 men with obstructive sleep apnoea ( Epworth score > 9 , and a > 4 % oxygen desaturation index of > 10 per h ) who were assigned to either therapeutic ( n = 59 ) or subtherapeutic ( 59 ) nCPAP ( about 1 cm H ( 2 ) O pressure ) for 1 month .\
METHODS	The primary outcome was the change in 24-h mean blood pressure .\
METHODS	Secondary outcomes were changes in systolic , diastolic , sleep , and wake blood pressure , and relations between blood pressure changes , baseline blood pressure , and severity of sleep apnoea .\
RESULTS	Therapeutic nCPAP reduced mean arterial ambulatory blood pressure by 2.5 mm Hg ( SE 0.8 ) , whereas subtherapeutic nCPAP increased blood pressure by 0.8 mm Hg ( 0.7 ) ( difference -3.3 [ 95 % CI -5.3 to -1.3 ] ; p = 0.0013 , unpaired t test ) .\
RESULTS	This benefit was seen in both systolic and diastolic blood pressure , and during both sleep and wake .\
RESULTS	The benefit was larger in patients with more severe sleep apnoea than those who had less severe apnoea , but was independent of the baseline blood pressure .\
RESULTS	The benefit was especially large in patients taking drug treatment for blood pressure .\
CONCLUSIONS	In patients with most severe sleep apnoea , nCPAP reduces blood pressure , providing significant vascular risk benefits , and substantially improving excessive daytime sleepiness and quality of life .\
\
###9207281\
OBJECTIVE	Because osteopenia increases morbidity of primary biliary cirrhosis ( PBC ) , the effects of cyclical etidronate vs. sodium fluoride on bone mass were compared in patients with PBC .\
METHODS	Thirty-two women with PBC were randomly assigned to receive etidronate ( 400 mg/day during 14 days every 3 months ) or fluoride ( 50 mg/day , enteric-coated tablets ) .\
METHODS	Bone mineral density of the lumbar spine and proximal femur were measured initially and every 6 months .\
METHODS	Bone fractures were also evaluated .\
RESULTS	Sixteen patients were allocated into each group , which were comparable with respect to the severity of PBC and osteopenia .\
RESULTS	Thirteen patients with etidronate and 10 patients with fluoride completed 2 years in the study .\
RESULTS	In the etidronate group , bone mineral density increased in the lumbar spine ( P = 0.02 ) and did not change in the proximal femur .\
RESULTS	In the fluoride group , lumbar bone mineral density did not change but femoral bone mass decreased , particularly in the Ward 's triangle .\
RESULTS	Two patients in the fluoride and none in the etidronate group developed new vertebral fractures , and the number of new nonvertebral fractures was similar in both groups .\
RESULTS	Neither treatment impaired liver function or cholestasis .\
CONCLUSIONS	Cyclical etidronate is more effective and better tolerated than sodium fluoride in preventing bone loss in PBC .\
\
###12767655\
OBJECTIVE	We analyzed the effects of vascular brachytherapy ( VBT ) on ostial in-stent restenosis ( ISR ) .\
BACKGROUND	In-stent restenosis has a high recurrence rate after percutaneous reintervention .\
BACKGROUND	The recurrence rate of ostial ISR lesions and the impact of VBT remain unknown .\
METHODS	We evaluated 133 patients with native coronary ostial ISR from a pooled database of 990 patients enrolled in randomized VBT trials .\
METHODS	Independent quantitative angiography was performed at baseline and follow-up in 45 gamma , 27 beta , and 61 placebo patients .\
RESULTS	Binary restenosis was significantly higher in placebo than radiated patients ( 75.4 % vs. 17.8 % in gamma vs. 22.2 % in beta , p < 0.0001 ) .\
RESULTS	The treatment effect of both gamma ( odds ratio [ OR ] 0.06 ; 95 % confidence interval [ CI ] 0.02 to 0.17 ) and beta VBT ( OR 0.10 ; 95 % CI 0.03 to 0.31 ) was maintained after controlling for differences in baseline lesion length .\
RESULTS	Proximal and distal radiation edge restenosis rates were similar among the groups .\
RESULTS	Vascular brachytherapy of true aorto-ostial lesions ( n = 34 ) was similarly beneficial : restenosis rates of placebo versus gamma or beta patients of 83.3 % versus 6.7 % versus 28.6 % , p = 0.0002 .\
CONCLUSIONS	Conventional treatment of ostial ISR is associated with a recurrence rate of over 75 % .\
CONCLUSIONS	Vascular brachytherapy with either gamma or beta sources results in significant and similar reductions in restenosis compared with placebo .\
CONCLUSIONS	Similar benefits after VBT prevail in true aorto-ostial lesions .\
\
###18356837\
OBJECTIVE	The endocannabinoid system ( ECS ) promotes weight gain and obesity-associated metabolic changes .\
OBJECTIVE	Weight loss interventions may influence obesity-associated risk indirectly through modulation of the peripheral ECS .\
OBJECTIVE	We investigated the effect of acute and chronic treatment with sibutramine on components of the peripheral ECS .\
METHODS	Twenty obese otherwise healthy patients received randomized , double-blind , crossover treatment with placebo and 15 mg/day sibutramine for 5 days each , followed by 12 weeks open-label sibutramine treatment .\
METHODS	We determined circulating anandamide and 2-arachidonoylglycerol and expression levels of endocannabinoid genes in subcutaneous abdominal adipose tissue biopsies .\
RESULTS	Body weight was stable during the acute treatment period and decreased by 6.0 + / -0.8 kg in those patients completing 3 months of sibutramine treatment ( P < 0.05 ) .\
RESULTS	Circulating endocannabinoids and the expression of ECS genes did not change with acute or chronic sibutramine treatment .\
CONCLUSIONS	The ECS is activated in obesity .\
CONCLUSIONS	We did not find any influence of 5 % body weight loss induced by sibutramine on circulating levels of endocannabinoids and adipose-tissue expression of endocannabinoid genes in obese subjects .\
CONCLUSIONS	These data confirm our previous findings on dietary weight loss and suggest that the dysregulation of the ECS may be a cause rather than a consequence of obesity .\
\
###23078631\
OBJECTIVE	To assess the bioequipotency of equimolar doses of idraparinux ( 2.5 mg ) and idrabiotaparinux ( 3.0 mg ) .\
METHODS	In a phase I study , 48 healthy male volunteers were randomized to a single subcutaneous injection of idrabiotaparinux or idraparinux , followed by plasma sampling over 27 days .\
METHODS	In a prospective substudy of the phase III EQUINOX trial , 228 patients treated for acute symptomatic deep vein thrombosis received idrabiotaparinux or idraparinux once weekly for 6 months .\
METHODS	Plasma sampling was performed within 5 days following the last injection .\
METHODS	The primary pharmacodynamic endpoint was the inhibition of activated factor X ( FXa ) activity .\
METHODS	Maximal anti-FXa activity ( Amax ) and area under anti-FXa activity vs. time curve ( AAUC ) were calculated .\
METHODS	Safety and tolerability were also assessed .\
RESULTS	In both studies , pharmacodynamic anti-FXavs .\
RESULTS	time profiles of idrabiotaparinux and idraparinux were superimposable .\
RESULTS	Ratio estimates ( 90 % confidence intervals [ CIs ] ) for idrabiotaparinux : idraparinux were 0.96 ( 0.89 , 1.04 ) for Amax and 0.95 ( 0.87 , 1.04 ) for AAUC in the phase I study , and 1.11 ( 1.00 , 1.22 ) for Amax and 1.06 ( 0.96 , 1.16 ) for AAUC at month 6 in the EQUINOX substudy .\
RESULTS	Idrabiotaparinux and idraparinux were considered bioequipotent because 90 % CIs were within the pre-specified interval ( 0.80 , 1.25 ) .\
RESULTS	Study treatments were well tolerated .\
CONCLUSIONS	Pharmacodynamic parameters reported after single dose in healthy volunteers and after repeated once weekly dosing in patients demonstrated the bioequipotency of idrabiotaparinux and idraparinux based on FXa inhibition .\
CONCLUSIONS	These outcomes support the use of an idrabiotaparinux dose bioequipotent to an idraparinux dose in large clinical trials , and the possibility to substitute idrabiotaparinux to idraparinux for the treatment of venous thromboembolism .\
\
###10586932\
OBJECTIVE	To compare central corneal swelling and light scatter after 8 hours of sleep in eyes wearing high - and low-Dk hydrogel lenses and to the contralateral control eyes .\
METHODS	Twenty neophyte subjects wore a Lotrafilcon A ( Dk , 140 ; Ciba Vision , Duluth GA ) silicone hydrogel lens and an Etafilcon A ( Dk , 18 ; Acuvue ; Vistakon , Jacksonville , FL ) 58 % water content hydrogel lens of similar center thickness in random order in the right eye only , for overnight 8-hour periods .\
METHODS	The contralateral nonwearing left eyes served as controls .\
METHODS	Central corneal thickness was measured using an optical pachometer and light scatter using a Van den Berg stray-light meter before lens insertion , after lens removal on waking , and every 20 minutes for the next 3 hours .\
RESULTS	Central corneal swelling induced by the Etafilcon A lens on eye opening was significantly higher than with the Lotrafilcon A lens ( 8.66 % + / -2.84 % versus 2.71 % + / -1.91 % ; P < 0.00001 ) .\
RESULTS	Light scatter induced by the Etafilcon A lens on eye opening was significantly higher than with the Lotrafilcon A lens ( 46.09 + / -5.62 versus 42.78 + / -6.07 Van den Berg units , P = 0.0078 ) .\
RESULTS	The swelling of the control eyes paired with the Etafilcon A lens-wearing eyes was also slightly but significantly higher than that of the control eyes paired with the Lotrafilcon A lens-wearing eyes ( 2.34 % + / -1.26 % versus 1.44 % + / -0.91 % ; P = 0.0002 ) .\
RESULTS	Light-scatter measurements were not significantly different between control sets of eyes but showed the same trend .\
CONCLUSIONS	In neophyte subjects , corneal swelling of the contralateral control eyes appears to be influenced by the swelling of the fellow lens-wearing eyes-that is , the swelling of the contralateral control eye was significantly lower when there was less swelling of the fellow eye wearing the high-Dk lens .\
CONCLUSIONS	Although there was no statistically significant difference in light-scatter measurements between the control sets of eyes , a trend similar to the corneal swelling results was observed , which could be used to support the suggestion that this may be a sympathetic physiological response rather than an unusual sampling coincidence .\
\
###21710355\
OBJECTIVE	Program evaluations are frequently based on ` then-test ' data , i.e. , pre-test collected in retrospect .\
OBJECTIVE	While the application of the then-test has practical advantages , little is known about the validity of then-test data .\
OBJECTIVE	Because of the collection of then-test in close proximity to post-test questions , this study was aimed at exploring whether the presence of then-test questions in post-test questionnaires influenced subjects ' responses to post-test .\
METHODS	To test the influence of then-test questions , we designed a randomized three-group study in the context of chronic disease self-management programs .\
METHODS	Interventions had comparable goals and philosophies , and all 949 study participants filled out identical Health Education Impact Questionnaires ( heiQ ) at pre-test .\
METHODS	At post-test , participants were then randomized to one of the following three groups : Group A responded to post-test questions only ( n = 331 ) ; Group B filled out transition questions in addition to post-test ( n = 304 ) ; and Group C filled out then-test questions in addition to post-test ( n = 314 ) .\
RESULTS	Significant post-test differences were found in six of eight heiQ scales , with respondents who filled out then-test questions reporting significantly higher post-test scores than respondents of the other groups .\
CONCLUSIONS	This study provides evidence that the inclusion of then-test questions alters post-test responses , suggesting that change scores based on then-test data be interpreted with care .\
\
###10640840\
BACKGROUND	Topically applied nail therapeutics need to permeate the nail plate to reach the nail bed or nail matrix and exert their potential beneficial effect at these locations to obtain a therapeutic benefit .\
BACKGROUND	So far only topically applied 5-fluorouracil on affected nails of psoriatic patients has been shown to produce a notable clearance .\
BACKGROUND	Vehicle formulations enhancing nail permeation processes are thought to increase the concentration of the active agent and therefore therapeutic efficacy , possibly enabling the use of a low concentration of the active agent thereby lowering the incidence of adverse effects .\
OBJECTIVE	This study was designed to verify whether a recently developed nail penetration enhancer in a lotion formulation , Belanyx ( ( R ) ) ( urea , propylene glycol ) , improves the efficacy of a low concentration of 5-fluorouracil ( 1 % ) in psoriatic fingernail lesions .\
METHODS	In a randomised , double-blind , left-right study the efficacy of 1 % 5-fluorouracil in the Belanyx vehicle was compared to the vehicle preparation Belanyx in dystrophic fingernails of 57 psoriatic patients .\
METHODS	Both preparations were applied in a once daily regimen for 12 weeks .\
METHODS	Responses and adverse effects of one selected target nail were recorded at screening , at baseline and at weeks 2 , 4 , 8 and 12 of treatment with a final assessment at week 16 : 4 weeks after the end of treatment .\
METHODS	As parameter of efficacy was chosen the total nail area severity ( NAS ) score , consisting of the separate parameters nail pitting area , number of nail pits , subungual keratosis , onycholysis , oil spots and the various scores of overall improvement .\
RESULTS	The efficacy of 1 % 5-fluorouracil in lotion and that of the vehicle in suppressing the parameters of dystrophy were shown to be similar at the end of treatment ( p = 0.063 ) or follow-up ( p = 0.130 ) .\
RESULTS	Both preparations produced statistically significant improvements ( p < / = 0.05 ) for almost all assessed parameters after 12 weeks of treatment and after the 4 weeks of follow-up .\
RESULTS	For Belanyx lotion this applied to the nail pitting area , the number of nail pits , subungual keratosis , onycholysis and oil spots .\
RESULTS	The investigators ' and patients ' opinion of overall improvement of severity as well as the total NAS score of one target nail likewise showed a statistically significant improvement at the end of treatment and at the end of the observation period ( p < / = 0.05 ) .\
RESULTS	With the 1 % 5-fluorouracil lotion the same statistically significant improvements were obtained in all of the assessed symptoms with the exception of the number of pits and onycholysis at week 12 and week 16 .\
RESULTS	Possible treatment-related adverse effects were established in 6 patients showing inflammation and infection ( 3 patients ) or discoloration ( 5 patients ) ; 3 patients on 5-fluorouracil lotion showed onycholysis .\
CONCLUSIONS	Addition of 1 % 5-fluorouracil to the nail permeation enhancer Belanyx does not increase the efficacy of the active agent in psoriatic nail dystrophy of this study population .\
CONCLUSIONS	The obtained results also suggest that Belanyx lotion can be used in this indication since it has shown a favourable efficacy-safety ratio .\
\
###8671965\
BACKGROUND	Oedema formation in the nephrotic syndrome is primarily due to tubular sodium retention .\
BACKGROUND	The pathogenetic role of alpha atrial natriuretic peptide ( ANP ) , a hormonal promoter of natriuresis is unknown .\
METHODS	In 31 patients ( aged 35 + / -11 years ) with nephrotic syndrome and histopathological evidence of primary glomerulonephritis , we investigated plasma ANP concentration and its influence on renal haemodynamics , natriuresis , and proteinuria ( total protein , albumin , IgG excretion ) .\
METHODS	Patients with a compensated treated form of nephrotic syndrome due to primary glomerulonephritis were included in the study .\
METHODS	Serum creatinine levels were < = 1.4 mg/dl .\
METHODS	Diuretic medication was discontinued at least 24 h before the investigation was started .\
METHODS	Patients were randomly assigned to ANP infusion ( 0.005 microg/kg * min ; group II , n = 15 ) or received placebo ( group III , n = 16 ) .\
METHODS	Ten healthy subjects ( group I ) served as normal controls .\
RESULTS	In normal subjects ( group I ) , ANP caused an increase in natriuresis from 14.5 + / -4.2 mmol/h to 26.4 + / -11.1 mmol/h ( P < 0.01 ) .\
RESULTS	In patients with nephrotic syndrome ( group II ) , baseline sodium excretion of 10.5 + / -6.0 mmol/h was increased to 19.6 + / -14.8 mmol/h with ANP infusion ( P < 0.01 ) .\
RESULTS	No changes were seen in the placebo group III .\
RESULTS	The absolute increase in ANP induced natriuresis was not significantly different between group I and II .\
RESULTS	However , plasma ANP levels were significantly higher in patients with nephrotic syndrome ( 166 + / -87 pg/ml vs. 74 + / -21 pg/ml , P < 0.05 ) and also reached higher levels after ANP infusion ( P < 0.01 ) .\
RESULTS	Therefore , natriuresis was significantly reduced when circulating ANP levels were taken into account ( P < 0.05 ) .\
RESULTS	ANP administration resulted in an increase of total protein excretion in patients with the nephrotic syndrome ( group II , from 219 + / -277 mg/h to 264 + / -268 mg/h ) .\
RESULTS	Albumin elimination rose from 128 + / -151 mg/h to 167 + / -170 mg/h ( P < 0.05 ) and IgG excretion from 4.91 + / -6.67 mg/h to 9.27 + / -10.78 mg/h ( P < 0.05 ) .\
RESULTS	Healthy subjects also showed a small but significant increase in albuminuria ( 48 + / -38 % , P < 0.05 ) .\
RESULTS	Low-dose ANP infusion did not , however , induce any significant alteration in GFR , ERPF and blood pressure .\
CONCLUSIONS	ANP plasma concentrations in the steady state are elevated in patients with the nephrotic syndrome .\
CONCLUSIONS	The natriuretic effect of ANP is reduced when referring to circulating ANP plasma levels .\
CONCLUSIONS	Elevated ANP levels enhance urinary protein excretion in the nephrotic syndrome .\
CONCLUSIONS	This is not due to modulation of GFR or FF , but is most probably attributable to increased glomerular permeability .\
\
###22676723\
BACKGROUND	Older adults receiving inpatient rehabilitation have low activity levels and poor mobility outcomes .\
BACKGROUND	Increased physical activity may improve mobility .\
BACKGROUND	The objective of this Phase II study was to evaluate the feasibility of a randomized controlled trial ( RCT ) of enhanced physical activity in older adults receiving rehabilitation .\
METHODS	Patients admitted to aged care rehabilitation with reduced mobility were randomized to receive usual care or usual care plus additional physical activity , which was delivered by a physiotherapist or physiotherapy assistant .\
METHODS	The feasibility and safety of the proposed RCT protocol was evaluated .\
METHODS	The primary clinical outcome was mobility , which was assessed on hospital admission and discharge by an assessor blinded to group assignment .\
METHODS	To determine the most appropriate measure of mobility , three measures were trialled ; the Timed Up and Go , the Elderly Mobility Scale and the de Morton Mobility Index .\
RESULTS	The protocol was feasible .\
RESULTS	Thirty-four percent of people admitted to the ward were recruited , with 47 participants randomised to a control ( n = 25 ) or intervention group ( n = 22 ) .\
RESULTS	The rates of adverse events ( death , falls and readmission to an acute service ) did not differ between the groups .\
RESULTS	Usual care therapists remained blind to group allocation , with no change in usual practice .\
RESULTS	Physical activity targets were met on weekdays but not weekends and the intervention was acceptable to participants .\
RESULTS	The de Morton Mobility Index was the most appropriate measure of mobility .\
CONCLUSIONS	The proposed RCT of enhanced physical activity in older adults receiving rehabilitation was feasible .\
CONCLUSIONS	A larger multi-centre RCT to establish whether this intervention is cost effective and improves mobility is warranted .\
BACKGROUND	The trial was registered with the ANZTCR ( ACTRN12608000427370 ) .\
\
###25112009\
OBJECTIVE	To explore the feasibility and safety of dexmedetomidine combined with remifentanil for lower eyelid blepharoplasty .\
METHODS	50 patients undergoing lower eyelid blepharoplasty ASA I - II were randomly divided into 2 groups ( 25 in each group ) as observation group and control group .\
METHODS	Dexmedetomidine ( 0.3 microg x kg ( -1 ) x h ( -1 ) ) and remifentanil ( 0.05 microg x kg ( -1 ) x min ( -1 ) ) were used in observation group .\
METHODS	Local anesthesia by lidocaine ( 1 % ) combined with midazolam ( 0.04 mg/kg ) intravenous sedation were used in control group .\
METHODS	HR , mean arterial pressure ( MAP ) , heart rate ( HR ) , breathing rate ( RR ) , pulse oxygen saturation ( SpO2 ) change were monitored and recorded before and after the administration of the drug , as well as at the beginning of operation , during the operation , at the end of the operation , and 5 minutes after the operation .\
METHODS	Patients sedation degree was evaluated by Ramsay .\
METHODS	Operation time , recovery time , the incidence of adverse reactions , the satisfaction of patients and doctors were also recorded .\
RESULTS	Patients had no obvious difference of intraoperative MAP , RR , SpO2 , operation time and postoperative recovery time between the two groups ( P > 0.05 ) .\
RESULTS	Compared with control group , HR during the operation were decreased significantly [ ( 64.2 + / - 8.2 ) bpm , P < 0.05 ] in observation group .\
RESULTS	In control group , there were 18 cases of patients with agitation , but they endured the operation anyway .\
RESULTS	In observation group , 24 cases of patients underwent operation without agitation .\
RESULTS	The satisfaction of patients and the operation doctors ( 96 % ) in observation group were markedly higher than that in control group ( P < 0.05 ) .\
CONCLUSIONS	Dexmedetomidine combined with remifentanil is practical and safe .\
CONCLUSIONS	The effect of reducing HR should be noticed .\
\
###19150573\
OBJECTIVE	Liquid-based cytology may offer improvements over conventional cytology for cervical cancer screening .\
OBJECTIVE	The two cytology techniques were compared in a group of 86,469 women who participated in a population-based screening program .\
OBJECTIVE	Using a nation-wide pathology database containing both cervical cytology and histology records for all patients , we compared the outcome of the two screenings methods with regard to the detection rate of histological proven abnormalities and the determination of the true false-negative rates for both methods .\
METHODS	Two cohorts of women living in the same geographical region were used .\
METHODS	Cohort 1 ( n = 51,154 women ) was analysed using conventional cytology ( conventional cohort ) and cohort 2 ( liquid cohort ) ( n = 35,315 women ) was analysed using liquid-based cytology ( SurePath ) .\
METHODS	The samples were processed in one laboratory .\
METHODS	The results of histological follow up were available via a central database .\
RESULTS	The rate of unsatisfactory slides was significantly lower using liquid-based cytology ( 0.13 % vs. 0.89 % , p < 0.0001 ) .\
RESULTS	Detection of ASCUS + ( Atypical squamous cells of unknown significance or higher abnormalities ) was significantly higher using liquid-based cytology ( 2.97 % vs. 1.64 % , p < 0.0001 ) , mainly due to the increase in the ASCUS category .\
RESULTS	The percentage of histological abnormalities within the ASCUS samples was approximately equal in both cohorts , indicating that more true abnormal cases were detected using liquid-based cytology .\
RESULTS	The sensitivity for detection of a histological proven lesion is significantly higher in the liquid cohort compared to the conventional cohort ( 96.2 % vs. 92.0 % ) , with only a slight difference in specificity ( 97.8 % vs. 98.2 % ) .\
CONCLUSIONS	This population study confirmed previous institution-based reports of decreased numbers of unsatisfactory samples based on liquid-based cytology and showed an increased sensitivity for the detection of cytological abnormalities that was validated by subsequent histological investigation .\
\
###24794451\
OBJECTIVE	to evaluate the clinical , hemodynamic , gas analysis and metabolic repercussions of high transient pressures of pneumoperitoneum for a short period of time to ensure greater security for introduction of the first trocar .\
METHODS	sixty-seven patients undergoing laparoscopic procedures were studied and randomly distributed in P12 group : n = 30 ( intraperitoneal pressure [ IPP ] 12mmHg ) and P20 group : n = 37 ( IPP of 20mmHg ) .\
METHODS	Mean arterial pressure ( MAP ) was evaluated by catheterization of the radial artery ; and through gas analysis , pH , partial pressure of oxygen ( PaO2 ) , partial pressure of CO2 ( PaCO2 ) , bicarbonate ( HCO3 ) and alkalinity ( BE ) were evaluated .\
METHODS	These parameters were measured in both groups at time zero before pneumoperitoneum ( TP0 ) ; at time 1 ( TP1 ) when IPP reaches 12mmHg in both groups ; at time 2 ( TP2 ) after five min with IPP = 12mmHg in P12 and after 5min with IPP = 20mmHg at P20 ; and at time 3 ( TP3 ) after 10min with IPP = 12mmHg in P12 and with return of IPP from 20 to 12mmHg , starting 10min after TP1 in P20 .\
METHODS	Different values from those considered normal for all parameters assessed , or the appearance of atypical organic phenomena , were considered as clinical changes .\
RESULTS	there were statistically significant differences in P20 group in MAP , pH , HCO3 and BE , but within normal limits .\
RESULTS	No clinical and pathological changes were observed .\
CONCLUSIONS	high and transient intra-abdominal pressure causes changes in MAP , pH , HCO3 and BE , but without any clinical impact on the patient .\
\
###20718170\
BACKGROUND	Nonsteroidal antiinflammatory drugs ( NSAIDs ) in combination with opioids is a model of multimodal analgesia .\
BACKGROUND	NSAIDs have the oral and parenteral forms .\
OBJECTIVE	The aim of the present study was to evaluate the efficacy of celecoxib compared with placebo and parecoxib after total hip or knee arthroplasty .\
METHODS	A total of 120 , ASA 1-2 , aged 18-75 years , patients were randomly assigned to receive one of the three groups : Group I ( control ) received placebo ( n = 40 ) , group II received 400 mg celecoxib orally ( n = 40 ) and group III received 40 mg parecoxib intravenously ( n = 40 ) .\
METHODS	The present study medication was administered I hour before surgery .\
METHODS	All patients had access to patient-controlled analgesia ( PCA ) with intravenous morphine .\
METHODS	Patients were studied at 0 , 1 , 6 , 12 and 24 hours postoperatively for verbal numerical rating scale ( VNRS ) , morphine consumption , satisfaction score and side effects .\
RESULTS	The intraoperatively fentayl requirement were similar among the three groups ( p < 0.00 ) .\
RESULTS	Celecoxib and parecoxib significantly decreased the amount of morphine requirement after total hip or knee arthroplasty compared to placebo at 1 , 6 , 12 and 24 hours ( p < 0.00 ) .\
RESULTS	The celecoxib group required more morphine than the parecoxib group at 1 , 6 , 12 and 24 hours ( p < 0.00 ) .\
RESULTS	The VNRS score in parecoxib group was significantly lower than the celecoxib and control groups at 1 , 6 , 12 but not at 24 hours .\
RESULTS	The VNRS score was lower in the celecoxib group compared to the control group at I and 6 hours postoperatively ( p = 0.01 , p < 0.01 respectively ) .\
RESULTS	The placebo group had a higher sedation score ( p = 0.008 ) but not for nausea vomiting ( p = 0.36 ) and pruritus ( p = 0.12 ) compared to the treatment groups .\
CONCLUSIONS	Within 12 hours after total hip and knee arthroplasty , pre-operative administration of parenteral parecoxib 40 mg was more effective than oral celecoxib 400 mg and placebo in terms of morphine consumption and VNRS score .\
\
###24389520\
BACKGROUND	Acute stress can increase fatigability and decrease steadiness of sustained low-force contractions that are required for functional tasks in upper limb muscles .\
BACKGROUND	Whether motor performance is more impaired in people with a chronic stress disorder is not known .\
OBJECTIVE	This study compared the fatigability and steadiness ( force fluctuations ) of handgrip muscles in veterans with posttraumatic stress disorder ( PTSD ) and civilian controls in the presence and absence of varying levels of cognitive demand .\
METHODS	Eighteen veterans with PTSD and 21 healthy controls ( 33 9 yr ) attended three randomized experimental sessions to perform an isometric fatiguing contraction ( 20 % of maximal strength ) with the handgrip muscles .\
METHODS	Two sessions involved performing a cognitive task during the fatiguing contraction : 1 ) difficult mental math task ( stressor ) and 2 ) a simple mental math task ( mental attentiveness ) .\
METHODS	A third session involved a fatiguing contraction with no mental task ( control ) .\
RESULTS	Stress elevated heart rate , blood pressure , and levels of anxiety in veterans with PTSD ( P < 0.05 ) but blunted cortisol levels ( P < 0.05 ) .\
RESULTS	Time to failure was briefer ( 7.2 2.5 vs 9.3 5.2 min , P = 0.03 ) , and force fluctuations increased at a greater rate for veterans with PTSD than for controls ( P < 0.05 ) .\
RESULTS	Cognitive stress did not influence time to failure or force fluctuations for either group ( P > 0.05 ) .\
CONCLUSIONS	Veterans with PTSD demonstrated greater fatigability and loss of steadiness ( greater force fluctuations ) of the handgrip muscles compared with healthy controls .\
CONCLUSIONS	Male veterans with PTSD demonstrated altered neuromuscular function of arm muscles that potentially affects functional tasks during daily , ergonomic , and military activities .\
\
###9627590\
OBJECTIVE	To evaluate the persistence of specific antibodies induced by primary immunization with three doses of two three-component acellular vaccines against pertussis with an observed efficacy of 84 % , and one whole-cell vaccine with an observed efficacy of 36 % .\
METHODS	Serum samples were collected from a subsample of 1572 children from the Italian double-blind , placebo-controlled , randomized trial of vaccines used in 15,601 children at three time points : before administration of the first dose of vaccine , and 1 month and approximately 15 months after administration of the third dose .\
METHODS	Further evaluation included pooled cross-sectional analysis of serum specimens associated with episodes of cough ( which were not laboratory confirmed as pertussis infection ) occurring among the entire population enrolled in the trial .\
RESULTS	With both acellular vaccines there was a fast and steep decrease in geometric mean antibody titers to pertussis toxin , filamentous hemagglutinin , and pertactin after vaccination .\
RESULTS	Mean titers were close to the limit of detection 15 months after primary immunization .\
RESULTS	The immunogenicity of the whole-cell study vaccine was poor 1 month after the third dose , and no antibody was detected in nearly all children 15 months after whole-cell vaccination .\
CONCLUSIONS	Although the study acellular pertussis vaccines induced a strong primary specific antibody response in almost all recipients , the duration of the response was limited .\
CONCLUSIONS	Sustained high-level production of antibody to the antigens tested does not account for the observed efficacy of acellular pertussis vaccines .\
\
###17324377\
OBJECTIVE	Studies have demonstrated that restorative procedures can initiate pulpal inflammation .\
OBJECTIVE	Adhesion molecules on endothelial cells mediate the leukocyte-endothelium interaction , which is the fundamental event of inflammation .\
OBJECTIVE	The aim of this study was to evaluate possible changes in the endothelial cell adhesion molecules ( CAMs ) of human dental pulp with tooth preparation , and after the application of one-step self-etch adhesive .\
METHODS	Twenty healthy human premolars and third molars scheduled to be extracted for orthodontic reasons were randomly assigned to four experimental groups .\
METHODS	Group 1 involved sound intact teeth representing the controls .\
METHODS	In group 2 , teeth were prepared for full crown and extracted within 2h .\
METHODS	Groups 3 and 4 comprised the teeth coated with one-step self-etch adhesive , iBond Gluma inside following the preparation and extracted after 24 and 48h , respectively .\
METHODS	Tissue distribution and staining intensity of CAMs including E-selectin , P-selectin , ICAM-1 , VCAM-1 and PECAM-1 was investigated in the pulp samples using monoclonal antibodies and the streptavidin-biotin-horse-radish immunoperoxidase procedure .\
METHODS	The assessment of immunohistochemical reactions was performed by two independent observers using a semi-quantitative scale .\
RESULTS	All the CAMs evaluated were expressed by the healthy pulp tissues .\
RESULTS	Significant alterations in the distribution and staining intensity of CAMs were detected following tooth preparation .\
RESULTS	One-step self-etch adhesive tested in the present study induced inflammatory reactions in the pulp ( P < 0.05 , Mann-Whitney U-test ) .\
CONCLUSIONS	It seems evident that tooth preparation for full crown and application of one-step self-etch adhesive on prepared teeth had a potential to interfere with the inflammatory response .\
\
###12386035\
OBJECTIVE	To estimate the incremental cost of implementing policies for intensive control of blood glucose concentration and blood pressure for all patients with type 2 diabetes in England .\
METHODS	Extrapolation of resource use and cost data derived from a randomised controlled trial .\
METHODS	General practice , outpatient care , and inpatient care .\
METHODS	Trial population with diagnosed type 2 diabetes in England extrapolated to the population of England .\
METHODS	Total costs based on use of healthcare resources including costs of management , treatment , and hospitalisation .\
RESULTS	The incremental net annual cost of implementing intensive control of blood glucose and blood pressure to all people with diagnosed type 2 diabetes in England is estimated to be pound 100.5 m ( $ 156m ; euro ; 159m ) , which is equivalent to less than 1 % of the proposed additional annual expenditure on the NHS in 2001-5 .\
RESULTS	This estimate varied in sensitivity analyses from pound 67m to pound 121m .\
CONCLUSIONS	Policies to improve control of blood glucose and blood pressure of people with type 2 diabetes are effective in reducing complications associated with the disease and are also cost effective .\
CONCLUSIONS	The total cost represents a small fraction of the NHS 's spending plans .\
\
###15755330\
BACKGROUND	Outreach facilitation has been proven successful in improving the adoption of clinical preventive care guidelines in primary care practice .\
BACKGROUND	The net costs and savings of delivering such an intensive intervention need to be understood .\
BACKGROUND	We wanted to estimate the proportion of a facilitation intervention cost that is offset and the potential for savings by reducing inappropriate screening tests and increasing appropriate screening tests in 22 intervention primary care practices affecting a population of 90,283 patients .\
METHODS	A cost-consequences analysis of one successful outreach facilitation intervention was done , taking into account the estimated cost savings to the health system of reducing five inappropriate tests and increasing seven appropriate tests .\
METHODS	Multiple data sources were used to calculate costs and cost savings to the government .\
METHODS	The cost of the intervention and costs of performing appropriate testing were calculated .\
METHODS	Costs averted were calculated by multiplying the number of tests not performed as a result of the intervention .\
METHODS	Further downstream cost savings were determined by calculating the direct costs associated with the number of false positive test follow-ups avoided .\
METHODS	Treatment costs averted as a result of increasing appropriate testing were similarly calculated .\
RESULTS	The total cost of the intervention over 12 months was $ 238,388 and the cost of increasing the delivery of appropriate care was $ 192,912 for a total cost of $ 431,300 .\
RESULTS	The savings from reduction in inappropriate testing were $ 148,568 and from avoiding treatment costs as a result of appropriate testing were $ 455,464 for a total savings of $ 604,032 .\
RESULTS	On a yearly basis the net cost saving to the government is $ 191,733 per year ( 2003 Can dollars ) equating to $ 3,687 per physician or $ 63,911 per facilitator , an estimated return on intervention investment and delivery of appropriate preventive care of 40 % .\
CONCLUSIONS	Outreach facilitation is more expensive but more effective than other attempts to modify primary care practice and all of its costs can be offset through the reduction of inappropriate testing and increasing appropriate testing .\
CONCLUSIONS	Our calculations are based on conservative assumptions .\
CONCLUSIONS	The potential for savings is likely considerably higher .\
\
###1743321\
OBJECTIVE	To find the treatment regimen giving a maximum chance of ovulation and a minimal chance of multiple follicular development in pulsatile gonadotropin-releasing hormone ( GnRH ) therapy in patients with hypothalamic amenorrhea .\
METHODS	We propectively studied the endocrinology of cycles induced with 5 , 10 , and 20 micrograms GnRH pulse doses , randomly assigned per patient , comparing this with the endocrinology of spontaneous menstrual cycles .\
METHODS	All patients were treated at the Academic Hospital of the Vrije Universiteit , Division of Reproductive Endocrinology and Fertility .\
METHODS	Fifteen patients with hypothalamic amenorrhea were treated for one to three cycles ; 14 normally cycling volunteers were studied for one cycle .\
METHODS	Number of ovulations per pulse dose ; luteinizing hormone , follicle-stimulating hormone , total urinary estrogens ( Es ) , and pregnanediol were measured per cycle day and per stimulation day .\
RESULTS	The endocrinology of all ovulatory cycles remained within the normal range .\
RESULTS	First treatment cycles showed significantly higher ovulation rates compared with subsequent cycles .\
RESULTS	Significantly more anovulation was observed in cycles with 5-micrograms pulse doses .\
RESULTS	Luteal Es were significantly higher in induction cycles compared with controls .\
CONCLUSIONS	The optimum treatment regimen should be to start induction with 5 micrograms/pulse in the first cycle and to raise the dose to 10 micrograms/pulse in subsequent cycles , regardless of the outcome of the first cycle .\
CONCLUSIONS	After ovulation , the pulse interval should be changed to 240 minutes .\
\
###10078487\
BACKGROUND	Data are limited and conflicting regarding the effectiveness of influenza vaccine in health care professionals .\
OBJECTIVE	To determine the effectiveness of trivalent influenza vaccine in reducing infection , illness , and absence from work in young , healthy health care professionals .\
METHODS	Randomized , prospective , double-blind , controlled trial over 3 consecutive years , from 1992-1993 to 1994-1995 .\
METHODS	Two large teaching hospitals in Baltimore , Md. .\
METHODS	Two hundred sixty-four hospital-based health care professionals without chronic medical problems were recruited ; 49 participated for 2 seasons ; 24 participated for 3 seasons .\
METHODS	The mean age was 28.4 years , 75 % were resident physicians , and 57 % were women .\
METHODS	Participants were randomly assigned to receive either an influenza vaccine or a control ( meningococcal vaccine , pneumococcal vaccine , or placebo ) .\
METHODS	Serum samples for antibody assays were collected at the time of vaccination , 1 month after vaccination , and at the end of the influenza season .\
METHODS	Active weekly surveillance for illness was conducted during each influenza epidemic period .\
METHODS	Serologically defined influenza infection ( 4-fold increase in hemagglutination-inhibiting antibodies ) , days of febrile respiratory illness , and days absent from work .\
RESULTS	We conducted 359 person-winters of serologic surveillance ( 99.4 % follow-up ) and 4746 person-weeks of illness surveillance ( 100 % follow-up ) .\
RESULTS	Twenty-four ( 13.4 % ) of 179 control subjects and 3 ( 1.7 % ) of 180 influenza vaccine recipients had serologic evidence of influenza type A or B infection during the study period .\
RESULTS	Vaccine efficacy against serologically defined infection was 88 % for influenza A ( 95 % confidence interval [ CI ] , 47 % -97 % ; P = .001 ) and 89 % for influenza B ( 95 % CI , 14 % -99 % ; P = .03 ) .\
RESULTS	Among influenza vaccinees , cumulative days of reported febrile respiratory illness were 28.7 per 100 subjects compared with 40.6 per 100 subjects in controls ( P = .57 ) and days of absence were 9.9 per 100 subjects vs 21.1 per 100 subjects in controls ( P = .41 ) .\
CONCLUSIONS	Influenza vaccine is effective in preventing infection by influenza A and B in health care professionals and may reduce reported days of work absence and febrile respiratory illness .\
CONCLUSIONS	These data support a policy of annual influenza vaccination of health care professionals .\
\
###12407615\
OBJECTIVE	To compare the analgesic efficacy of a traditional epidurally delivered bupivacaine/fentanyl combination with a repeat bolus intrathecal morphine technique in the management of post-thoracotomy pain and to assess further the effect of cyclooxygenase ( COX ) inhibition on both modalities .\
METHODS	Prospective , randomized , blinded study .\
METHODS	University teaching hospital .\
METHODS	Patients having thoracic surgery .\
METHODS	Epidural and intrathecal catheters were inserted .\
METHODS	Blood and urine samples were collected for analysis .\
METHODS	COX-1 and COX-2 inhibition with ibuprofen and nimesulide ( COX-2 selective ) was instituted .\
RESULTS	Pain was assessed at rest and coughing by visual analog scale .\
RESULTS	Peak expiratory flow rate , patient satisfaction rating , sedation score , analgesic requirements , and preoperative and postoperative urinary creatinine levels were measured .\
RESULTS	The spinal and nimesulide combination showed the lowest pain scores ( p < 0.001 ) , least reduction in peak expiratory flow rate ( p < 0.001 ) , and highest patient satisfaction rating ( p = 0.02 ) .\
RESULTS	COX inhibition did not affect analgesic requirements in the epidural group or increase urinary creatinine in any group .\
CONCLUSIONS	The intrathecal morphine and nimesulide combination offered significantly better analgesia than any other combination studied .\
CONCLUSIONS	The efficacious interaction between opioids and nonsteroidal anti-inflammatory drugs may be COX-2 mediated .\
\
###21849041\
BACKGROUND	A randomized trial of vinorelbine plus gemcitabine followed by docetaxel ( VGD ) versus paclitaxel plus carboplatin ( PC ) in patients with advanced non-small-cell lung cancer showed no difference in overall survival ( median survival time : 13.6 versus 14.1 months ) between the two treatment groups .\
BACKGROUND	We report here the results of quality-of-life ( QOL ) study initiated in the mid-course of this randomized trial .\
METHODS	The patients themselves assessed the Functional Assessment of Cancer Therapy ( FACT ) - Lung ( FACT-L ) , FACT-Taxane and the Functional Assessment of Chronic Illness Therapy - Spirituality ( FACIT-Sp ) QOL instruments at baseline and 6 , 12 and 18 weeks after the treatment .\
METHODS	The primary endpoint was a comparison of total QOL score for each assessment instrument between the two groups .\
RESULTS	Sixty-eight patients from the trial ( VGD , 34 ; PC , 34 ) who submitted baseline questionnaires and at least one questionnaire over the course of treatment were eligible .\
RESULTS	Longitudinal analysis showed a significant difference in slope of the FACT-Taxane score ( p = 0.004 ) between treatment regimens over time , but no difference was found in FACT-L score ( p = 0.311 ) and FACIT-Sp score ( p = 0.466 ) between the two groups .\
CONCLUSIONS	The significant difference in slope of FACT-Taxane score favored the VGD regimen .\
CONCLUSIONS	These data should be considered in treatment decision-making for patients with advanced non-small-cell lung cancer .\
BACKGROUND	NCT00242983 .\
\
###15383107\
OBJECTIVE	To evaluate rectal diclofenac in the relief of perineal pain after trauma during childbirth .\
METHODS	A randomised , double-blind trial .\
METHODS	Delivery Suite , Women 's and Children 's Hospital , South Australia .\
METHODS	Women with a second-degree ( or greater ) perineal tear or episiotomy .\
METHODS	Women were randomly allocated to either diclofenac or placebo suppositories ( Anusol ) , using a computer-generated randomisation schedule with stratification for parity and mode of birth .\
METHODS	Treatment packs contained two x 100 mg diclofenac or two placebo suppositories , the first being inserted when suturing was complete , and the second 12-24 hours after birth .\
METHODS	Women were asked to complete questionnaires at 24 and 48 hours after birth relating to their degree of perineal pain using the validated Short Form McGill Pain Questionnaire .\
METHODS	Pain scores at 24 and 48 hours after birth .\
RESULTS	A total of 133 women were recruited , with 67 randomised to diclofenac suppositories and 66 to placebo .\
RESULTS	Women in the diclofenac group were significantly less likely to experience pain at 24 hours while walking ( RR 0.8 ; 95 % CI 0.6 to 1.0 ) , sitting ( RR 0.8 ; 95 % CI 0.6 to 1.0 ) , passing urine ( RR 0.6 ; 95 % CI 0.4 to 1.0 ) and on opening their bowels ( RR 0.6 ; 95 % CI 0.2 to 0.9 ) compared with those women who received placebo .\
RESULTS	These differences were not sustained 48 hours after birth .\
CONCLUSIONS	The use of rectal non-steroidal anti-inflammatory drug suppositories is a simple , effective and safe method of reducing the pain experienced by women following perineal trauma within the first 24 hours after childbirth .\
\
###20923485\
BACKGROUND	Intensive treatment of patients with Type 2 diabetes mellitus ( T2DM ) from the moment of diagnosis facilitates - cell recovery .\
BACKGROUND	Self-monitoring of blood glucose ( SMBG ) - based educational and pharmacological intervention may be better than conventional HbA1c algorithms in the treatment of newly diagnosed T2DM .\
METHODS	Newly diagnosed T2DM patients were randomized to either an SMBG-based intervention or an HbA1c-based control group ( n = 99 and 62 , respectively ) and were followed for 1 year .\
RESULTS	Higher rates of diabetes regression ( HbA1c < 6 % on metformin alone ) and remission ( HbA1c between 6.0 % and 6.4 % ) were achieved in the intervention compared with the control group ( 39 % vs 5 % ( P < 0.001 ) and 37 % vs 30 % ( P < 0.01 ) , respectively ) .\
RESULTS	Furthermore , significantly greater reductions in median HbA1c ( 6.6 % to 6.1 % ; P < 0.05 ) and body mass index ( 29.6-27 .9 kg/m ( 2 ) ; P < 0.001 ) were seen in the intervention over the 1 year of therapy .\
RESULTS	The percentage of patients achieving a lifestyle score > 12 was significantly greater in the SMBG compared with the control group ( 38.4 % vs 9.7 % respectively ; P < 0.001 ) .\
RESULTS	An inverse correlation was observed between SMBG and HbA1c levels ( P < 0.04 ) .\
CONCLUSIONS	The results indicate that SMBG-based structured educational and pharmacological programs empower patients to achieve nutritional and physical activity goals , and encourage physicians and patients to use SMBG to optimize therapy .\
CONCLUSIONS	We believe that the concept of intensive treatment of T2DM patients should be modified ; instead of referring to the type of treatment ( insulin use ) , the term should reflect the intensity with which we work to reach glucose objectives .\
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###22980307\
BACKGROUND	No randomized trial has been conducted to compare different vasodilators for treating no-reflow during primary percutaneous coronary intervention ( PCI ) for ST-segment elevation acute myocardial infarction .\
METHODS	The prospective , randomized , 2-center trial was designed to compare the effect of 3 different vasodilators on coronary no-reflow .\
METHODS	A total of 102 patients with no-reflow in primary PCI were randomized to receive intracoronary infusion of diltiazem , verapamil , or nitroglycerin ( n = 34 in each group ) through selective microcatheter .\
METHODS	The primary end point was coronary flow improvement in corrected thrombolysis in myocardial infarction frame count ( CTFC ) after administration of the drug .\
RESULTS	Compared with that of the nitroglycerin group , there was a significant improvement of CTFC after drug infusion in the diltiazem and verapamil groups ( 42.4 frames vs 28.1 and 28.4 frames , P < .001 ) .\
RESULTS	The improvement in CTFC was similar between the diltiazem and verapamil groups ( P = .9 ) .\
RESULTS	Compared with the nitroglycerin group , the diltiazem and verapamil groups had more complete ST-segment resolution at 3 hours after PCI , lower peak troponin T level , and lower N-terminal pro-B-type natriuretic peptide levels at 1 and 30 days after PCI .\
RESULTS	After drug infusion , the drop of heart rate and systolic blood pressure in the verapamil group was greater than that in the diltiazem and nitroglycerin groups .\
CONCLUSIONS	Intracoronary infusion of diltiazem or verapamil can reverse no-reflow more effectively than nitroglycerin during primary PCI for acute myocardial infarction .\
CONCLUSIONS	The efficacy of diltiazem and verapamil is similar , and diltiazem seems safer .\
\
###9973914\
OBJECTIVE	The safety and diagnostic efficacy of iodixanol ( Visipaque ) 270 mg I/ml was compared to that of iopamidol ( Iopamiron ) 300 mg I/ml in knee arthrography .\
METHODS	This trial was a bi-center double-blind trial including 128 patients ( iodixanol/iopamidol 64/64 patients ) .\
METHODS	Efficacy was evaluated by blinded grading of the diagnostic quality of the p.a. images taken 0 , 12 and 25 min after contrast administration by the examining radiologist and later at a consensus evaluation by two experienced skeletal radiologists .\
METHODS	Adverse events were recorded .\
RESULTS	No patient experienced any adverse event .\
RESULTS	The proportion of better images at both 12 and 25 min after injection was higher in the iodixanol group compared to the iopamidol group both by the examining radiologist and at the consensus evaluation .\
CONCLUSIONS	In the knee joint iodixanol is a safe contrast medium .\
CONCLUSIONS	The contrast effect of iodixanol lasted longer than that of iopamidol , which can be important when performing arthrography , especially CT arthrography , where the time between puncture and examination can be prolonged .\
\
###25423958\
BACKGROUND	The Radiation Reduction During Cardiac Catheterization Using Real-Time Monitoring study sought to examine the effect of a radiation detection device that provides real-time operator dose reporting through auditory feedback ( Bleeper Sv ; Vertec Scientific Ltd ; Berkshire , UK ) on patient dose and operator exposure during cardiac catheterization .\
RESULTS	Between January 2012 and May 2014 , 505 patients undergoing coronary angiography , percutaneous coronary intervention , or both were randomized to use ( n = 253 ) or no use ( n = 252 ) of the Bleeper Sv radiation monitor .\
RESULTS	Operator radiation exposure was measured in both groups using a second , silent radiation exposure monitoring device .\
RESULTS	Mean patient age was 658 years , most patients ( 99 % ) were men , and 30 % had prior coronary artery bypass graft surgery .\
RESULTS	Baseline clinical characteristics were similar in the 2 study groups .\
RESULTS	Radial access was used in 18 % and chronic total occlusion percutaneous coronary intervention constituted 7 % of the total procedures .\
RESULTS	Median procedure time was 17 ( 12-27 ) minutes for diagnostic angiography , 42 ( 28-70 ) minutes for percutaneous coronary intervention , and 27 ( 14-51 ) minutes in the overall study population , with similar distribution between the study groups .\
RESULTS	First ( 9 [ 4-17 ] versus 14 [ 7-25 ] Sv ; P < 0.001 ) and second ( 5 [ 2-10 ] versus 7 [ 4-14 ] Sv ; P < 0.001 ) operator radiation exposure was significantly lower in the Bleeper Sv group .\
RESULTS	Use of the device did not result in a significant reduction in patient radiation dose .\
RESULTS	The effect of the Bleeper Sv device on operator radiation exposure was consistent among various study subgroups .\
CONCLUSIONS	Use of a real-time radiation monitoring device that provides auditory feedback can significantly reduce operator radiation exposure during cardiac catheterization .\
BACKGROUND	http://www.clinicaltrials.gov .\
BACKGROUND	Unique identifier : NCT01510353 .\
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###22428485\
BACKGROUND	Preliminary data on the perioperative use of dexmedetomidine in patients undergoing craniotomy for brain tumor under general anaesthesia indicate that the intraoperative administration of dexmedetomidine is opioid-sparing , results in less need for antihypertensive medication , and may offer greater hemodynamic stability at incision and emergence .\
BACKGROUND	Dexmedetomidine , alpha 2 adrenoceptor agonist used as adjuvant to anaesthetic agents .\
BACKGROUND	Relatively recent studies have shown that dexmedetomidine is able to decrease circulating plasma norepinephrine and epinephrine concentration in approximately 50 % , decreases brain blood flow by directly acting on post-synaptic alpha 2 receptors , decreases CSF pressure without ischemic suffering and effectively decrease brain metabolism and intracranial pressure and also , able to decrease injury caused by focal ischemia .\
OBJECTIVE	This prospective , randomized , double-blind study was designed to assess the perioperative effect of intraoperative infusion of dexmedetomidine in patients with supratentorial tumors undergoing craniotomy under general anaesthesia .\
METHODS	Forty patients with CT - scanning proof of supratentorial tumors .\
METHODS	The patients were classified equally into 2 groups ( twenty patients in each group ) .\
METHODS	Group A : -- The dexmedetomidine was given as a bolus dose of 1 microg/kg in 20 minutes before induction of anaesthesia , followed by a maintenance infusion of 0.4 microg/kg/hr .\
METHODS	The infusion was discontinued when surgery ended .\
METHODS	Group B : -- The patients received similar volumes of saline .\
RESULTS	The heart rate and mean arterial blood pressure , decreased in patients of group A ( dexmedetomidine group ) more than group B ( placebo group ) with significant statistical difference between the two groups ( P-value < 0.05 ) .\
RESULTS	No significant statistical difference between the two groups regarding the central venous pressure and arterial partial pressure of Carbon Dioxide ( P-value > 0.05 ) .\
RESULTS	The intraoperative end-tidal sevoflurane ( % ) in patients of group A less than in patients of group B ( P-value < 0.05 ) .\
RESULTS	The intracranial pressure decreased in patients of Group A more than group B ( P-value < 0.05 ) .\
RESULTS	The Glasgow coma scale ( GCS ) improved in patients of group A and deteriorated in patients of Group B with significant statistical difference between the two groups ( P-value < 0.05 ) .\
RESULTS	The total fentanyl requirements from induction to extubation of patients increased in patients of group B more than in patients of group A ( P-value < 0.05 ) .\
RESULTS	The total postoperative patients ' requirements for antiemetic drugs within the 2 hours after extubation decreased in patients of group A more than group B ( P-value < 0.05 ) .\
RESULTS	The postoperative duration from the end of surgery to extubation decreased significantly in patients of group A more than group B ( P-value < 0.05 ) .\
RESULTS	The total urine output during the duration from drug administration to extubation of patients increased in patients of group A more than group B ( P-value < 0.05 ) .\
CONCLUSIONS	Continuous intraoperative infusion of dexmedetomidine during craniotomy for supratentorial tumors under general anaesthesia maintained the haemodynamic stability , reduced sevoflurane and fentanyl requirements , decreased intracranial pressure , and improved significantly the outcomes .\
\
###21285171\
OBJECTIVE	This Year 5 analysis of an open-label extension ( OLE ) study assessed radiographic progression , clinical efficacy , and safety of adalimumab with concomitant methotrexate ( MTX ) for patients with active rheumatoid arthritis .\
METHODS	In a double-blind study ( DE019 , NCT00195702 ) , inadequate responders to MTX were randomized to MTX plus either adalimumab 40 mg eow , adalimumab 20 mg weekly , or placebo for 52 weeks .\
METHODS	Eligible patients entered an ongoing OLE and received adalimumab 40 mg eow plus MTX .\
METHODS	Longterm efficacy and safety were evaluated .\
RESULTS	Of 457 patients who had enrolled in the OLE , 304 remained in the study at Year 5 , including 112 , 107 , and 85 from the original adalimumab 40 mg , adalimumab 20 mg , and placebo groups , respectively .\
RESULTS	Year 5 radiographs demonstrated mean changes in modified total Sharp score for the original adalimumab 40 mg eow and 20 mg weekly groups of 0.8 and 2.6 , respectively , versus 3.9 for placebo ; 58 % from the adalimumab 40 mg eow group had no radiographic progression versus 40 % of those who initially received placebo .\
RESULTS	Of patients who received adalimumab 40 mg eow for 5 years , 26.1 % achieved clinical remission ( Disease Activity Score 28-joint count < 2.6 ) , had no radio graphic progression ( change in modified total Sharp score 0.5 ) , and had normal function ( Health Assessment Questionnaire 0.5 ) , versus 11.9 % of those who initially received placebo .\
RESULTS	Serious infection rate for 553 patients who received at least one dose of adalimumab was 4.4 / 100 patient-years .\
CONCLUSIONS	A 52-week delay in adding adalimumab to MTX led to worse radiographic , functional , and clinical outcomes at Year 5 for most patients who initially received placebo instead of adalimumab .\
\
###12165639\
BACKGROUND	Breast irradiation after lumpectomy is an integral component of breast-conserving therapy that reduces the local recurrence of breast cancer .\
BACKGROUND	Because an optimal fractionation schedule ( radiation dose given in a specified number of fractions or treatment sessions over a defined time ) for breast irradiation has not been uniformly accepted , we examined whether a 22-day fractionation schedule was as effective as the more traditional 35-day schedule in reducing recurrence .\
METHODS	Women with invasive breast cancer who were treated by lumpectomy and had pathologically clear resection margins and negative axillary lymph nodes were randomly assigned to receive whole breast irradiation of 42.5 Gy in 16 fractions over 22 days ( short arm ) or whole breast irradiation of 50 Gy in 25 fractions over 35 days ( long arm ) .\
METHODS	The primary outcome was local recurrence of invasive breast cancer in the treated breast .\
METHODS	Secondary outcomes included cosmetic outcome , assessed with the European Organisation for Research and Treatment of Cancer ( EORTC ) Cosmetic Rating System .\
METHODS	All statistical tests were two-sided .\
RESULTS	From April 1993 through September 1996 , 1234 women were randomly assigned to treatment , 622 to the short arm and 612 to the long arm .\
RESULTS	Median follow-up was 69 months .\
RESULTS	Five-year local recurrence-free survival was 97.2 % in the short arm and 96.8 % in the long arm ( absolute difference = 0.4 % , 95 % confidence interval [ CI ] = -1.5 % to 2.4 % ) .\
RESULTS	No difference in disease-free or overall survival rates was detected between study arms .\
RESULTS	The percentage of patients with an excellent or good global cosmetic outcome at 3 years was 76.8 % in the short arm and 77.0 % in the long arm ; the corresponding data at 5 years were 76.8 % and 77.4 % , respectively ( absolute difference = -0.6 % , 95 % CI = -6.5 % to 5.5 % ) .\
CONCLUSIONS	The more convenient 22-day fractionation schedule appears to be an acceptable alternative to the 35-day schedule .\
\
###25428762\
BACKGROUND	In clinical practice , nonsteroidal anti-inflammatory drugs ( NSAIDs ) are commonly discontinued after response to biologic therapy is achieved in patients with axial spondyloarthritis ( axSpA ) , but the impact of NSAID discontinuation has not been assessed in prospective controlled trials .\
BACKGROUND	The aim of the SPARSE study was to evaluate the effects of the anti-tumor necrosis factor agent etanercept on NSAID intake and conventional clinical outcomes in axSpA patients .\
METHODS	In the double-blind , placebo-controlled period , patients with active ( mini Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) 4 ) axSpA despite optimal NSAID intake were randomized to receive etanercept 50mg or placebo once weekly for 8weeks .\
METHODS	All patients were advised to taper/discontinue their NSAID intake during the treatment period .\
METHODS	NSAID intake was self-reported by diary and Assessment of SpondyloArthritis International Society ( ASAS ) - NSAID scores calculated based on ASAS recommendations .\
METHODS	The primary endpoint was change from baseline to week 8 in ASAS-NSAID score ( analysis of covariance ) .\
RESULTS	In 90 randomized patients at baseline , mean age ( standard deviation ) was 38.9 ( 11.8 ) years ; disease duration , 5.7 ( 8.1 ) years ; 59/90 ( 66 % ) were human leukocyte antigen-B27 positive ; 51/90 ( 57 % ) had radiographic sacroiliitis ; and 45/90 ( 50 % ) were magnetic resonance imaging sacroiliitis-positive .\
RESULTS	Mean ASAS-NSAID scores were similar between etanercept and placebo groups at baseline ( 98.2 ( 39.0 ) versus 93.0 ( 23.4 ) ) , as were BASDAI ( 6.0 ( 1.7 ) versus 5.9 ( 1.5 ) ) , and Bath Ankylosing Spondylitis Functional Index ( 5.2 ( 2.1 ) versus 5.1 ( 2.2 ) ) .\
RESULTS	Mean changes ( SE ) in ASAS-NSAID score from baseline to week 8 were -63.9 ( 6.1 ) and -36.6 ( 5.9 ) in the etanercept and placebo groups ( between-group difference , -27.3 ; P = 0.002 ) .\
RESULTS	Significantly higher proportions of patients receiving etanercept versus placebo had an ASAS-NSAID score < 10 ( 46 % versus 17 % ; P = 0.008 ) and ASAS-NSAID score of 0 ( 41 % versus 14 % ; P = 0.013 ) at this time point .\
RESULTS	Significantly more patients in the etanercept versus placebo group achieved BASDAI50 ( 39 % versus 18 % ; P = 0.032 ) and ASAS40 ( 44 % versus 21 % ; P = 0.028 ) at week 8 .\
CONCLUSIONS	In patients with axSpA , etanercept was associated with clinically relevant NSAID-sparing effects in addition to significant improvements in conventional clinical outcomes .\
BACKGROUND	ClinicalTrials.gov NCT01298531 .\
BACKGROUND	Registered 16 February 2011 .\
\
###23039926\
OBJECTIVE	To assess the impact of a multi-tiered oral health education programme on care staff caring for people with intellectual disability ( ID ) .\
METHODS	Postal questionnaires were sent to all care staff of a community-based residential care service for adults , randomly assigned to control and intervention groups .\
METHODS	A specifically developed training programme was delivered to residential staff nominees , who then trained all staff within the intervention group .\
METHODS	The control group received no training .\
METHODS	Post-test questionnaires were sent to both groups .\
METHODS	Paired-samples t-test was used to compare oral health-related knowledge ( K ) and behaviour , attitude and self-efficacy ( BAS ) scores .\
RESULTS	Of the initial 219 respondents , 154 ( response rate between 40 % and 35.8 % , with attrition rate of 29.7 % from baseline to repeat ) returned completed questionnaires at post-test ( M = 8.5 months , range = 6.5-11 months ) .\
RESULTS	Control and intervention groups were comparable for general training , employment and demographic variables .\
RESULTS	In the intervention group , mean Knowledge Index score rose from K = 7.2 to K = 7.9 ( P < 0.001 ) and mean BAS scale score rose from BAS = 4.7 to BAS = 5.4 ( P < 0.001 ) .\
RESULTS	There was no statistically significant increase in mean scores from test ( K = 7.0 , BAS = 4.7 ) to post-test ( K = 7.2 , BAS = 4.9 ) for the control group .\
CONCLUSIONS	Mean scores regarding knowledge , attitude , self-efficacy and reported behaviour increased significantly at 8.5 months in staff where training was provided .\
CONCLUSIONS	The results indicate that a multi-tiered training programme improved knowledge , attitude , self-efficacy and reported behaviour amongst staff caring for people with ID .\
\
###25377567\
BACKGROUND	The determination of dosing regimens for the treatment of malaria is largely empirical and thus a better understanding of the pharmacokinetic/pharmacodynamic properties of antimalarial agents is required to assess the adequacy of current treatment regimens and identify sources of suboptimal dosing that could select for drug-resistant parasites .\
BACKGROUND	Mefloquine is a widely used antimalarial , commonly given in combination with artesunate .\
METHODS	Mefloquine pharmacokinetics was assessed in 24 healthy adults and 43 patients with Plasmodium falciparum malaria administered mefloquine in combination with artesunate .\
METHODS	Population pharmacokinetic modelling was conducted using NONMEM .\
RESULTS	A two-compartment model with a single transit compartment and first-order elimination from the central compartment most adequately described mefloquine concentration-time data .\
RESULTS	The model incorporated population parameter variability for clearance ( CL/F ) , central volume of distribution ( VC/F ) and absorption rate constant ( KA ) and identified , in addition to body weight , malaria infection as a covariate for VC/F ( but not CL/F ) .\
RESULTS	Monte Carlo simulations predict that falciparum malaria infection is associated with a shorter elimination half-life ( 407 versus 566 h ) and T > MIC ( 766 versus 893 h ) .\
CONCLUSIONS	This is the first known population pharmacokinetic study to show falciparum malaria to influence mefloquine disposition .\
CONCLUSIONS	Protein binding , anaemia and other factors may contribute to differences between healthy individuals and patients .\
CONCLUSIONS	As VC/F is related to the earlier portion of the concentration-time profiles , which occurs during acute malaria , and CL/F is more related to the terminal phase during convalescence after treatment , this may explain why malaria was found to be a covariate for VC/F but not CL/F .\
\
###24660837\
BACKGROUND	Data regarding immunomodulatory effects of parenteral n-3 fatty acids in sepsis are conflicting .\
BACKGROUND	In this study , the effect of administration of parenteral n-3 fatty acids on markers of brain injury , incidence of sepsis-associated delirium , and inflammatory mediators in septic patients was investigated .\
METHODS	Fifty patients with sepsis were randomized to receive either 2 ml/kg/day of a lipid emulsion containing highly refined fish oil ( equivalent to n-3 fatty acids 0.12 mg/kg/day ) during 7 days after admission to the intensive care unit or standard treatment .\
METHODS	Markers of brain injury and inflammatory mediators were measured on days 1 , 2 , 3 and 7 .\
METHODS	Assessment for sepsis-associated delirium was performed daily .\
METHODS	The primary outcome was the difference in S-100 from baseline to peak level between both the intervention and the control group , compared by t-test .\
METHODS	Changes of all markers over time were explored in both groups , fitting a generalized estimating equations model .\
RESULTS	Mean difference in change of S-100 from baseline to peak level was 0.34 ( 95 % CI : -0.18 -0.85 ) between the intervention and control group , respectively ( P = 0.19 ) .\
RESULTS	We found no difference in plasma levels of S-100 , neuron-specific enolase , interleukin ( IL ) -6 , IL-8 , IL-10 , and C-reactive protein between groups over time .\
RESULTS	Incidence of sepsis-associated delirium was 75 % in the intervention and 71 % in the control groups ( risk difference 4 % , 95 % CI -24 -31 % , P = 0.796 ) .\
CONCLUSIONS	Administration of n-3 fatty acids did not affect markers of brain injury , incidence of sepsis-associated delirium , and inflammatory mediators in septic patients .\
\
###18954956\
OBJECTIVE	The objective of the study was to investigate the effect of a priori information on preferences for treatment elicited in a discrete choice experiment .\
METHODS	A convenience sample of 100 subjects was randomly split into two groups .\
METHODS	The groups received minimal or extensive information on the treatment of ankle and foot impairment in stroke .\
METHODS	Then , they participated in a discrete choice experiment .\
METHODS	Possible treatment was described using eight decision criteria with two to four levels each .\
METHODS	Part-worth utility coefficients for the criteria levels , criteria importance and overall treatment preference were estimated .\
METHODS	It was tested whether the amount of information that was received influenced the outcome of the discrete choice experiment .\
RESULTS	In the extensively informed group fewer reversals in the expected order of part-worth utilities were found .\
RESULTS	Criteria importance for four of the eight criteria and criteria importance ranking between the minimally and extensively informed subject groups were significantly different .\
RESULTS	The difference in part-worth utility of the levels had a minor effect on the predicted utility of the available treatments .\
CONCLUSIONS	The lower number of level rank reversals in the extensively informed subjects indicates a better understanding of outcome desirability and thus a better understanding of the decision task .\
CONCLUSIONS	The effect of more extensive information on predicted treatment preference was minimal .\
CONCLUSIONS	While interpreting the results of a discrete choice experiment , the effect of prior knowledge on the decision problem has to be taken into account .\
CONCLUSIONS	Although information seems to increase the understanding of the decision task , outcomes valuation can also be directed by information and more extensive information increases the cognitive burden which is placed on the subjects .\
CONCLUSIONS	Future research should focus on the exact nature and size of the effects and the results of this study should be clinically validated .\
\
###9850822\
OBJECTIVE	To evaluate the efficacy of alpha-beta L-Aspartate Magnesium ( Asp Mg ) in discontinuation of long-term benzodiazepine use and to search for a predictive model of success for BZD cessation .\
METHODS	Using a double-blind procedure , 144 patients selected as chronic users of one of 3 BZD lorazepam , alprazolam or bromazepam ( duration of use > 6 months ; regular dose > or = 3 mg lorazepam equivalent ) and with clinical remission ( score on Hamilton-Anxiety < 14 ; Raskin-Depression < 6 ) had entered a controlled study ( versus placebo ) and were randomized in two parallel groups .\
METHODS	The trial was conducted on 3 consecutive phases ( co-administration of Asp Mg or placebo with BZD during 1 month ; gradual taper of BZD during 1 month ; follow-up during a third month after complete BZD discontinuation , with urinary BZD control on d75 and d90 ) .\
RESULTS	The intent-to-treat analysis showed at the endpoint an overall rate of 80 % of `` BZD discontinuation '' and of 35.4 % of `` BZD cessation without withdrawal '' in the total population ( no significant intergroup differences were observed on these rates ) .\
RESULTS	However , there were some tendencies to positive differences between Asp Mg versus placebo on the following : 1 ) prolonged delay of BZD use if reintake ( 30 days vs 20 days , p [ log-rank ] = 0.5 ) ; 2 ) reduction of withdrawal intensity : 11 % of important difficulties during BZD cessation versus 23 % with placebo ( p = 0.2 ) and on Benzodiazepine Withdrawal Symptoms Questionnaire ( BWSQ ) ( final score 4.0 vs 4.8 , p = 0.10 ) ; 3 ) lower modification of anxiety during BZD tapering and discontinuation ( rate of increase on HAM-A between d30-d90 of 6 % vs 23 % in placebo group , p = 0.10 ) .\
RESULTS	Moreover , 3 predictive factors of `` success '' ( BZD cessation without withdrawal phenomenon ) were identified by uni - and multivariate analysis with logistic regression : chronicity of anxiety disorder ( p = 0.04 ) and amplitude of BWSQ change during tapering phase ( p < 0.0001 ) as negative factors ; and initial score of Speilberger Anxiety Inventory `` Anxiety-Trait '' ( p = 0.002 ) as positive factor .\
RESULTS	A predictive model is constructed according to these 3 parameters .\
RESULTS	Further clinical trials are needed to explore the benefits of alpha-beta L-Aspartate Magnesium in different criteria of prescription ( dosage , duration of treatment , repetitive cures ... ) .\
\
###19809809\
OBJECTIVE	Fenugreek seeds ( Trigonella foenum-graecum L. ) are an old herbal remedy used to treat metabolic and nutritive dysfunctions .\
OBJECTIVE	They have been shown to modulate feeding behaviour in animals , but strong clinical data are lacking .\
OBJECTIVE	The aim of this study was to investigate the effects of a repeated administration of a fenugreek seed extract on energy intake and eating behaviour in healthy human volunteers .\
METHODS	Twelve healthy male volunteers completed a double-blind randomized placebo-controlled three-period cross-over trial of two different doses of a fenugreek seed extract ( 588 and 1176 mg ) .\
METHODS	The three 14-day treatment periods were separated by a 14-day washout period .\
METHODS	The main endpoints were energy intake , assessed in volunteers under normal ambulatory and free-living conditions by a 3-day detailed dietary record and during a meal test , weight , fasting glucose level , insulin and lipid profile , visual analogue scale scores of appetite/satiety and blood glucose and insulin levels measured repeatedly after a standardized breakfast .\
RESULTS	Daily fat consumption was significantly decreased by the higher dose of fenugreek seed extract [ 3.73 vs. 4.51 MJ day ( -1 ) , -17.3 % vs. placebo , 95 % confidence interval ( CI ) -1.51 to -0.05 , n = 12 , P = 0.038 ] .\
RESULTS	This specific reduction tended to lower the total energy intake ( 9.97 vs. 11.29 MJ day ( -1 ) , -11.7 % vs. placebo , 95 % CI -2.91 to 0.26 , n = 12 , P = 0.094 ) .\
RESULTS	No significant effect was observed on the other nutrients or other endpoints .\
CONCLUSIONS	The repeated administration of a fenugreek seed extract specifically decreases dietary fat consumption in humans which , given the traditional use of the plant , constitutes a novel result .\
\
###10501817\
OBJECTIVE	Iloprost , an analogue of prostacyclin , is often utilised in subjects with diabetes mellitus complicated by macroangiopathy .\
METHODS	The effects of iloprost infusion on plasminogen activator inhibitor type-1 ( PAI-1 ) , glucometabolic control and cardiovascular equilibrium in patients with type-2 diabetes mellitus and peripheral arterial occlusive disease were investigated .\
METHODS	Thirteen ( 7 men/6 women ) normal-weight , normotensive and non-smoker type-2 diabetic patients ( 63.8 + / - 3.4 years , mean + / - SD ) with peripheral arterial occlusive disease , stage-II according to Fontaine classification , were enrolled .\
METHODS	Eight ( four men/four women ) patients underwent three study designs , each separated by a 1-week interval : study I , infusion of iloprost ( 3 ng kg ( -1 ) min ( -1 ) for 5 h ) for 1 day alone ( short-term treatment ) ; study II , infusion of saline ( for 5 h ) for 1 day ( control treatment ) ; study III , infusion of iloprost ( 3 ng kg ( -1 ) min ( -1 ) for 5 h ) over a period of 28 days ( long-term treatment ) .\
METHODS	The remaining five ( three men/two women ) patients underwent study IV only , infusion of saline over a period of 28 days ( placebo treatment ) .\
METHODS	Plasma levels of glucose , plasminogen , PAI-1 activity and fibrinogen , blood pressure and heart rate were determined in all studies , while plasma insulin levels , blood HbA ( 1c ) , walking distance and Winsor index only in studies III and IV .\
RESULTS	Both short - and long-term treatments with iloprost significantly reduced PAI-1 activity ( baseline vs end : 17.4 + / - 1.9 AU/ml vs 15.0 + / - 1.6 AU/ml , P < 0.02 ; 20.5 + / - 7.6 AU/ml vs 7.9 + / - 2.1 AU/ml , P < 0.002 , respectively ) .\
RESULTS	Long-term treatment with iloprost significantly increased walking distance ( baseline vs end : 325 + / - 41 m vs 496 + / - 52 m , P < 0.0001 ) , but not Winsor index .\
RESULTS	Neither glucometabolic control nor cardiovascular equilibrium were affected by short - and long-term treatments with iloprost .\
RESULTS	Control and placebo treatments did not cause any significant modifications in the parameters evaluated .\
CONCLUSIONS	If confirmed by further investigations , the results of this pilot study suggest that iloprost , infused for both brief and long periods , is able to reduce the cardiovascular risk factor PAI-1 , increases free walking capacity and does not affect glucometabolic control and blood pressure in type-2 diabetic patients complicated by macroangiopathy .\
\
###23690414\
OBJECTIVE	Cancer-related-fatigue ( CRF ) is common in advanced cancer .\
OBJECTIVE	The primary objective of the study was to compare the effects of methylphenidate ( MP ) with those of placebo ( PL ) on CRF as measured using the Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F ) fatigue subscale .\
OBJECTIVE	The effect of a combined intervention including MP plus a nursing telephone intervention ( NTI ) was also assessed .\
METHODS	Patients with advanced cancer with a fatigue score of 4 out of 10 on the Edmonton Symptom Assessment Scale ( ESAS ) were randomly assigned to one of the following four groups : MP+NTI , PL+NTI , MP + control telephone intervention ( CTI ) , and PL+CTI .\
METHODS	Methylphenidate dose was 5 mg every 2 hours as needed up to 20 mg per day .\
METHODS	The primary end point was the median difference in FACIT-F fatigue at day 15 .\
METHODS	Secondary outcomes included anxiety , depression , and sleep .\
RESULTS	One hundred forty-one patients were evaluable .\
RESULTS	Median FACIT-F fatigue scores improved from baseline to day 15 in all groups : MP+NTI ( median score , 4.5 ; P = .005 ) , PL+NTI ( median score , 8.0 ; P < .001 ) , MP+CTI ( median score , 7.0 ; P = .004 ) , and PL+CTI ( median score , 5.0 ; P = .03 ) .\
RESULTS	However , there were no significant differences in the median improvement in FACIT-F fatigue between the MP and PL groups ( 5.5 v 6.0 , respectively ; P = .69 ) and among all four groups ( P = .16 ) .\
RESULTS	Fatigue ( P < .001 ) , nausea ( P = .01 ) , depression ( P = .02 ) , anxiety ( P = .01 ) , drowsiness ( P < .001 ) , appetite ( P = .009 ) , sleep ( P < .001 ) , and feeling of well-being ( P < .001 ) , as measured by the ESAS , significantly improved in patients who received NTI .\
RESULTS	Grade 3 adverse events did not differ between MP and PL ( 40 of 93 patients v 29 of 97 patients , respectively ; P = .06 ) .\
CONCLUSIONS	MP and NTI alone or combined were not superior to placebo in improving CRF .\
\
###23748990\
OBJECTIVE	The objective of this study was to explore the positive aspects experienced by adult children in providing care to their parent who has either Parkinson 's or Alzheimer 's disease .\
METHODS	A qualitative descriptive approach was used to analyze audiotaped in-depth semistructured interviews that were conducted with 34 adult children who were primary caregivers as part of a larger randomized clinical trial .\
METHODS	Individual interviews were conducted by trained research assistants in the caregiver 's home .\
METHODS	Thirty-four adult children caregivers who were primary caregivers for their respective 34 parents .\
METHODS	Seventy-six percent ( n = 26 ) of the caregivers were caring for a parent with Alzheimer 's disease .\
METHODS	Twenty-four percent ( n = 8 ) were caring for a parent with Parkinson 's disease .\
METHODS	Eighty-two percent were adult daughters .\
METHODS	Mean age of the caregiver was 52 years , and the mean age of the parent was 81 years .\
METHODS	Fifty-three percent of caregivers were white , and 47 % were black .\
METHODS	A conventional content analysis was performed to summarize themes .\
RESULTS	Results indicated that most caregivers had positive experiences .\
RESULTS	Three relationship-centered themes were identified : spending and enjoying time together , appreciating each other and becoming closer , and giving back care .\
RESULTS	A small number of caregivers ( n = 6 ) could not identify positive experiences .\
CONCLUSIONS	Caregivers who had positive experiences in caregiving expressed fewer feelings of being overwhelmed or distressed by their situations .\
CONCLUSIONS	Further study is needed on caregivers who do not experience positive aspects in caring for a parent , and these caregivers potentially may be a group that warrants further intervention by advanced practice nurses .\
\
###22995880\
OBJECTIVE	The goal of this analysis was to determine the association between intraprocedural complications and clinical outcomes among patients with high-risk non-ST-segment elevation acute coronary syndrome ( NSTEACS ) undergoing percutaneous coronary intervention ( PCI ) .\
BACKGROUND	Among patients undergoing PCI for NSTEACS , the relationship between intraprocedural complications and clinical outcomes , independent of epicardial and myocardial perfusion , has not been well characterized .\
METHODS	The EARLY ACS ( Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome ) trial enrolled 9,406 patients with high-risk NSTEACS undergoing an early invasive strategy .\
METHODS	Of these , 1,452 underwent angiographic assessment in an independent core laboratory and did not have a myocardial infarction ( MI ) between enrollment and angiography .\
METHODS	We assessed the relationship between abrupt closure , loss of side branch ( es ) , distal embolization , and no-reflow phenomenon and 30-day clinical outcomes in these patients .\
RESULTS	Of the patients , 166 ( 11.4 % ) experienced an intraprocedural complication .\
RESULTS	Baseline clinical characteristics were similar between patients who did and did not have complications .\
RESULTS	The 30-day composite of death or MI was significantly higher among patients with an intraprocedural complication ( 28.3 % vs. 7.8 % , odds ratio [ OR ] : 4.68 , 95 % confidence interval [ CI ] : 3.2 to 7.0 , p < 0.001 ) .\
RESULTS	Individually , both mortality ( 3.0 % vs. 0.9 % , OR : 3.60 , 95 % CI : 1.2 to 10.5 , p = 0.019 ) and MI ( 27.1 % vs. 7.4 % , OR : 4.66 , 95 % CI : 3.1 to 7.0 , p < 0.001 ) were significantly increased .\
RESULTS	After adjusting for differences in post-PCI epicardial and myocardial perfusion , the association with 30-day death or MI remained significant .\
CONCLUSIONS	Among high-risk NSTEACS patients undergoing an invasive strategy , the incidence of intraprocedural complications is high , and the occurrence of these complications is associated with worse clinical outcomes independent of epicardial and myocardial perfusion .\
CONCLUSIONS	( Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome [ EARLY ACS ] ; NCT00089895 ) .\
\
###23965206\
OBJECTIVE	To determine whether the use of tranexamic acid in the setting of hypotension induced by hypotensive epidural anesthesia ( HEA ) has any additional beneficial effects in reducing perioperative blood loss and transfusion requirements in total hip replacement .\
METHODS	Prospective , randomized , double-blinded trial .\
METHODS	University-affiliated hospital .\
METHODS	68 adult , ASA physical status 1 and 2 patients undergoing primary unilateral cementless total hip replacement with general anesthesia and HEA .\
METHODS	The HEATA group received a bolus dose of 15 mg/kg of tranexamic acid before surgical incision , followed by a continuous 15 mg/kg infusion until skin closure .\
METHODS	The HEA group received normal saline instead of tranexamic acid in the same manner .\
METHODS	Intraoperative blood loss was measured using the difference between the weights of used gauze and the original unused gauze , in addition to the blood volume accumulated in suction bottles .\
METHODS	Postoperative blood loss was considered to be the amount of blood accumulated in drainage bags .\
RESULTS	There was no significant difference in intraoperative blood loss between the HEA and HEATA groups ( 251.8 109.9 mL vs. 234.9 93.9 mL ) , but postoperative blood loss was significantly less in the HEATA group than the HEA group ( 439.3 171.6 mL vs. 1074.4 287.1 mL ) , as was total cumulative blood loss ( 674.2 216.4 mL vs. 1326.2 347.8 mL ) .\
RESULTS	There was no significant difference in intraoperative transfusion incidences , but postoperative transfusion was greater in the HEA group than the HEATA group .\
CONCLUSIONS	Administration of tranexamic acid combined with hypotensive epidural anesthesia reduced postoperative and total accumulative blood loss and transfusion requirements more than did hypotensive epidural anesthesia alone .\
\
###12375321\
OBJECTIVE	To evaluate the effect of a culturally sensitive cholesterol lowering diet program on lipid and lipoproteins , body weight , nutrient intakes , and quality of life ( QOL ) in patients with systemic lupus erythematosus ( SLE ) .\
METHODS	Seventeen patients with SLE were randomized to a Step 2 diet intervention group or a control group for 12 weeks .\
METHODS	The diet intervention was made up of weekly group sessions during the first 6 weeks followed by telephone counseling every 2 weeks for the last 6 weeks .\
METHODS	Data on fasting lipid and lipoproteins , body weight , food intake ( 3 day food record ) , and QOL were collected at baseline , 6 weeks , and 12 weeks .\
METHODS	Program acceptability was assessed in the diet group at 6 weeks .\
RESULTS	The intervention was found to be highly acceptable and culturally sensitive .\
RESULTS	The changes in nutrient intakes at 6 and 12 weeks in the diet group were -49 % and -33 % , respectively , for cholesterol , -44 % and -32 % , respectively , for percentage calories from fat , and -46 % and -32 % , respectively , for percentage calories from saturated fat .\
RESULTS	The corresponding figures in the control group were +22 % and -8 % for cholesterol , +9 % and +6 % for percentage calories from fat , and +5 % and +7 % for percentage calories from saturated fat .\
RESULTS	The treatment by time interaction was significant for all the dietary variables ( p = 0.0003 to 0.02 ) .\
RESULTS	QOL was reported to improve by 15-17 % in the diet group and decrease by 4-6 % in the control group , and the treatment by time interaction was significant ( p = 0.05 ) .\
RESULTS	The changes in the physiological variables at 6 and 12 weeks in the diet group were -10 % and -6 % , respectively , for total cholesterol , -10 % and -2 % , respectively , for low density lipoprotein ( LDL ) cholesterol , -11 % and -4 % , respectively , for high density lipoprotein ( HDL ) cholesterol , -25 % and -34 % , respectively , for very low density lipoprotein ( VLDL ) cholesterol , -8 % and -24 % , respectively , for triglycerides , and -2 % and -5 % , respectively , for body weight .\
RESULTS	The corresponding figures in the control group were -5 % and -3 % for total cholesterol , -6 % and -5 % for LDL cholesterol , 0 % and +12 % for HDL cholesterol , +4 % and -8 % for VLDL cholesterol , -6 % and -15 % for triglycerides , and -5 % and -6 % for body weight .\
RESULTS	The treatment by time interaction was significant for HDL cholesterol ( p = 0.04 ) .\
RESULTS	A significant reduction was seen in the diet group for total cholesterol at 6 and 12 weeks , LDL and HDL cholesterol at 6 weeks , and body weight at 12 weeks ( p = 0.0002 to 0.01 ) .\
CONCLUSIONS	This culturally sensitive cholesterol reducing diet program was highly accepted and effective in changing the diet and QOL of patients with SLE .\
CONCLUSIONS	The effect on serum lipids , lipoproteins , and body weight , however , was modest .\
CONCLUSIONS	A larger randomized study with a longer intervention period is necessary to test the effectiveness of a cholesterol-lowering diet on lipids and lipoproteins in patients with SLE .\
\
###23883137\
BACKGROUND	In Switzerland , people with a severe mental illness and unable to work receive disability benefits ( ` IV-pension ' ) .\
BACKGROUND	Once they are granted these benefits , the chances to regain competitive employment are usually small .\
BACKGROUND	However , previous studies have shown that individual placement and support ( IPS ) supports a successful reintegration into competitive employment .\
BACKGROUND	This study focuses on the integration of newly appointed IV-pensioners , who have received an IV-pension for less than a year .\
METHODS	The present pilot project ZHEPP ( Zrcher Eingliederungs-Pilot Projekt ; engl. : Zurich integration pilot project ) is a randomized controlled trial ( RCT ) .\
METHODS	The 250 participants will be randomized to either the intervention or the control group .\
METHODS	The intervention group receives support of a job coach according to the approach of IPS .\
METHODS	Participants in the control group do not receive IPS support .\
METHODS	Participation takes a total of two years for each participant .\
METHODS	Each group is interviewed every six months ( T0-T4 ) .\
METHODS	A two-factor analysis of variance will be conducted with the two factors group ( intervention versus control group ) and outcome ( employment yes/no ) .\
METHODS	The main criterion of the two-factor analysis will be the number of competitive employment contracts in each group .\
CONCLUSIONS	This study will focus on the impact of IPS on new IV-pensioners and aims to identify predictors for a successful integration .\
CONCLUSIONS	Furthermore , we will examine the effect of IPS on stigma variables and recovery orientation .\
BACKGROUND	ISRCTN54951166 .\
\
###12969112\
BACKGROUND	Forced-air warming is known as an effective procedure in prevention and treatment of perioperative hypothermia .\
BACKGROUND	Significant differences have been described between forced-air warming systems in combination with full body blankets .\
BACKGROUND	We investigated four forced-air warming systems in combination with upper body blankets for existing differences in heat transfer .\
METHODS	After approval of the local Ethics Committee and written informed consent , four forced-air warming systems combined with upper body blankets were investigated in a randomized cross-over trial on six healthy volunteers : ( 1 ) BairHugger trade mark 505 and Upper Body Blanket 520 , Augustine Medical ; ( 2 ) ThermaCare trade mark TC 3003 , Gaymar trade mark and Optisan trade mark Upper Body Blanket , Brinkhaus ; ( 3 ) WarmAir trade mark 134 and FilteredFlow trade mark Upper Body Blanket , CSZ ; and ( 4 ) WarmTouch trade mark 5800 and CareDrape trade mark Upper Body Blanket , Mallinckrodt .\
METHODS	Heat transfer from the blanket to the body surface was measured with 11 calibrated heat flux transducers ( HFTs ) with integrated thermistors on the upper body .\
METHODS	Additionally , the blanket temperature was measured 1 cm above the HFT .\
METHODS	After a preparation time of 60 min measurements were started for 20 min .\
METHODS	Mean values were calculated over 20 min .\
METHODS	The t-test for matched pairs with Bonferroni-Holm-correcture for multiple testing was used for statistical evaluation at a P-level of 0.05 .\
METHODS	The values are presented as mean + / - SD .\
RESULTS	The WarmTouch trade mark blower with the CareDrape trade mark blanket obtained the best heat flux ( 17.0 + / -3.5 W ) .\
RESULTS	The BairHugger trade mark system gave the lowest heat transfer ( 8.1 + / -1.1 W ) .\
RESULTS	The heat transfer of the ThermaCare trade mark system and WarmAir trade mark systems were intermediate with 14.3 + / -2.1 W and 11.3 + / -1.0 W.\
CONCLUSIONS	Based on an estimated heat loss from the covered area of 38 W the heat balance is changed by 46.1 W to 55 W by forced-air warming systems with upper body blankets .\
CONCLUSIONS	Although the differences in heat transfer are significant , the clinical relevance of this difference is small .\
\
###7758234\
OBJECTIVE	The observation that phaeochromocytoma possess specific somatostatin binding sites led us to test the hypothesis that octreotide may have antisecretory potential in patients with phaeochromocytoma .\
OBJECTIVE	We therefore compared the effects of octreotide and placebo on blood pressure and plasma catecholamines and neuropeptide Y.\
METHODS	Ten consecutive patients referred to a tertiary care centre for the diagnosis and treatment of a phaeochromocytoma .\
METHODS	We performed a crossover comparison of either three 100 micrograms subcutaneous injections of octreotide over one day or 3 injections of octreotide vehicle over another .\
METHODS	Blood pressure was measured over 24 hours on each test day using an automatic ambulatory recorder .\
METHODS	Blood samples were collected before ( at 0800 and 0900 h ) and after ( at 1000 , 1100 , 1200 , 1300 and 1500 h ) placebo or octreotide injection .\
METHODS	Plasma catecholamines were assayed by high-performance liquid chromatography and neuropeptide Y was determined using a two-site amplified enzyme immunoassay .\
METHODS	All patients then underwent surgery and tumoral somatostatin binding site density was determined by quantitative autoradiography .\
RESULTS	Compared to placebo , octreotide did not alter mean 24-hour ambulatory blood pressure or plasma neuropeptide Y , or plasma or urinary catecholamine , levels .\
RESULTS	Although a moderate reduction in plasma noradrenaline was found in the two patients with the highest tumoral somatostatin binding site densities , overall octreotide-induced variations in plasma noradrenaline did not correlate with somatostatin binding site density .\
RESULTS	Blood glucose increased from 5.4 + / - 0.3 on placebo to 7.8 + / - 0.5 mmol/l on octreotide ( P < 0.01 ) .\
CONCLUSIONS	In the present controlled conditions , short-term administration of octreotide had no antisecretory effect in patients with phaeochromocytoma .\
\
###7828793\
OBJECTIVE	To evaluate the effects of isradipine ( ISR ) and diltiazem ( DIL ) on exercise tolerance and ischemic ST depression in patients with stable effort angina .\
METHODS	Fourteen out-patients , 9 males and 5 females , aged 46-65 years ( mean + / - SD = 57 + / - 8 ) , with ischemic heart disease and reproducible ST-segment depression on two consecutive exercise stress tests in baseline conditions , underwent a study consisting of 4 periods : 1 and 3 placebo , 2 and 4 at random ISR ( 5 mg b.i.d. ) and DIL ( 120 mg b.i.d. ) .\
METHODS	At the end of each period a multistage treadmill exercise stress test ( Bruce protocol ) was performed .\
RESULTS	Both drugs significantly ( p < 0.001 ) increased ischemia time ( IT ) ( 0.1 mV ST depression ) as compared to placebo , from 438 + / - 132 s. to 620 + / - 164 s. ( ISR ) and 583 + / - 147 s. ( DIL ) without statistical difference between two drugs ( p = 0.2 ) , and significantly reduced ( p < 0.002 ) the maximal ST depression , from -0.20 + / - 0.11 mV to -0.07 + / - 0.07 mV ( ISR ) and -0.09 + / - 0.11 mV ( DIL ) .\
RESULTS	At the IT , systolic blood pressure increased ( p = 0.02 ) , from 180 + / - 19 mm Hg to 187 + / - 15 mm Hg ( ISR ) and 191 + / - 15 mm Hg ( DIL ) ; similarly , heart rate increased from 133 + / - 24 bpm to 144 + / - 18 bpm ( ISR : p = 0.002 ) and 140 + / - 17 bpm ( DIL : p = NS ) .\
CONCLUSIONS	ISR and DIL , at the above dosage have showed an important and significant anti-ischemic effect ( IT = +41.5 % during ISR and +33.1 % during DIL ) .\
\
###9349933\
OBJECTIVE	The pharmacokinetics of 6-mercaptopurine , including cerebrospinal-fluid ( CSF ) distribution , and the erythrocyte 6-thioguanine nucleotide concentrations were determined in children randomised to receive intravenous mercaptopurine for acute lymphoblastic leukaemia ( ALL ) , according to the EORTC protocol ALL n. 58881 .\
RESULTS	After 1 month of oral treatment at a dose of 50 mg.m-2 .\
RESULTS	day-1 , the pharmacokinetic parameters were determined after the first i.v. administration of 1 g.m-2 ( bolus dose of 0.2 g.m-2 followed by an 8-h infusion of 0.8 g.m-2 ) in 11 patients : systemic clearance was 23.02 1.h-1 , volume of distribution was 0.75 l.kg-1 , and elimination half-life was 1.64 h.\
RESULTS	The erythrocyte thioguanine concentrations were measured in the same 11 patients and increased significantly between the beginning and the end of infusion ( 10 pmol x 10 ( 8 ) packed RBC ) or within 24 h of infusion ( 223 pmol x 10 ( 8 ) packed RBC ) .\
RESULTS	The CSF concentration was 3.78 mumol .1 ( -1 ) , 1-6 h after the beginning of infusion ( n = 28 ) and the CSF to plasma ratio was 0.15 ( n = 16 ) .\
RESULTS	In patients receiving the oral dose of 50-165 mg.m-2 .\
RESULTS	day-1 of 6-mercaptopurine , CSF concentrations were below 0.18 mumol .1 ( -1 ) , 1-24 h after drug intake ( n = 67 ) , and the CSF to plasma ratio was not calculated .\
CONCLUSIONS	Following the i.v. administration of 6-mercaptopurine , we observed high CSF concentrations of 6-mercaptopurine and an acute increase of erythrocyte thioguanine nucleotide concentrations .\
CONCLUSIONS	The clinical trial ( EORTC protocol ALL n [ symbol : see text ] 5881 ) , comparing the oral and i.v. administrations of mercaptopurine , will demonstrate if the i.v. administration reduces the incidence of CNS relapses .\
\
###10408450\
OBJECTIVE	To compare the anterior surface cytologic features and effect on blood-aqueous barrier of polymethyl methacrylate , silicone , and hydrogel intraocular lens ( IOL ) implants to give an indication of their biocompatibility .\
METHODS	This prospective study was performed at an English-teaching hospital .\
METHODS	Ninety eyes were randomized to receive a polymethyl methacrylate , silicone , or hydrogel implant .\
METHODS	A standardized surgical protocol was performed by a single surgeon using phacoemulsification .\
METHODS	Patients were seen at intervals for 1 year .\
METHODS	Measurements of visual acuity , contrast sensitivity , and anterior chamber laser flare and cells were obtained ; and an assessment of lens cytologic features using specular microscopy of the anterior IOL surface was performed .\
RESULTS	Visual acuity and contrast sensitivity were not significantly different among the 3 groups .\
RESULTS	Hydrogel IOLs were associated with fewer inflammatory cells on their surface than polymethyl methacrylate and silicone IOLs ( P < .001 ) , but with significantly more lens epithelial cells ( LECs ) ( P < .001 ) .\
RESULTS	Patients with hydrogel implants without LECs had greater blood-aqueous barrier breakdown than those with LECs .\
CONCLUSIONS	The hydrogel IOLs were associated with a reduced inflammatory cell reaction but had many more LECs on their anterior surface .\
CONCLUSIONS	Those IOLs associated with increased blood-aqueous barrier damage did not develop LECs .\
CONCLUSIONS	If an IOL is too biocompatible , then it may incite the growth of LECs over its surface , which could have disadvantages .\
\
###16938153\
OBJECTIVE	This study was designed to evaluate early postoperative cognitive recovery after total intravenous anaesthesia with remifentanil-propofol or sufentanil-propofol in patients undergoing craniotomy for supratentorial expanding lesions .\
METHODS	Sixty patients were consecutively enrolled , and randomly assigned to one of two study groups : remifentanil-propofol or sufentanil-propofol anaesthesia .\
METHODS	To evaluate cognitive function the Short Orientation Memory Concentration Test ( SOMCT ) and Rancho Los Amigos Scale ( RLAS ) were administered to all patients in a double-blind procedure before surgery at 15 , 45 min and 3 h after extubation .\
RESULTS	Mean extubation time was similar in the two groups ( 13 + / - 5 min vs. 19 + / - 6 min ) .\
RESULTS	A significantly larger number of patients in the remifentanil-propofol group than in the sufentanil-propofol group required antihypertensive medication postoperatively to maintain mean arterial pressure within 20 % of baseline ( 18/30 vs. 4/29 ; P = 0.0004 ) .\
RESULTS	Intergroup analysis showed no differences in baseline SOMCT scores ( 28 + / - 1 vs. 28 + / - 1 ) whereas mean SOMCT scores at 15 , 45 min and 3 h after extubation were significantly higher in the remifentanil-propofol group ( 30 patients ) than in the sufentanil-propofol group ( 29 patients ) ( 22 + / - 3 vs. 16 + / - 3 ; P < 0.0001 and 27 + / - 1 vs. 22 + / - 3 ; P < 0.0001 ; 28 + / - 1 vs. 26 + / - 2 ; P = 0.0126 ) .\
CONCLUSIONS	In conclusion , propofol-remifentanil and propofol-sufentanil are both suitable for fast-track neuroanaesthesia and provide similar intraoperative haemodynamics , awakening and extubation times .\
CONCLUSIONS	Despite a higher risk of treatable postoperative hypertension propofol-remifentanil allows earlier cognitive recovery .\
\
###17502627\
OBJECTIVE	We report the long-term survival and toxicity of a randomized phase III study comparing cisplatin alone with cisplatin , flurouracil , and hydroxyurea versus hydroxyurea concurrent with pelvic irradiation for patients with locally advanced cervical cancer with pathologically negative para-aortic nodes .\
METHODS	Comparisons of progression-free ( PFS ) and overall survival ( OS ) between treatment arms utilized Kaplan-Meier and log-rank statistics .\
METHODS	Relative risk estimates adjusting for prognostic factors were determined using the Cox proportional hazards regression model .\
METHODS	Pearson 's 2 test was used to assess differences in adverse events .\
RESULTS	The analysis included 526 patients .\
RESULTS	The median follow-up among surviving patients was 106 months .\
RESULTS	Consistent with the original report , improvement in PFS and OS was evident for both cisplatin-containing arms compared with hydroxyurea ( P < .001 ) .\
RESULTS	Analogous results were seen for stage IIB and for stage III disease ( each P < .025 ) .\
RESULTS	The relative risk of progression of disease or death was 0.57 ( 95 % CI , 0.43 to 0.75 ) with cisplatin and 0.51 ( 95 % CI , 0.38 to 0.67 ) with cisplatin-based combination chemotherapy compared with hydroxyurea .\
RESULTS	Among 518 patients who received radiation , acute ( grade 3 or 4 ) gastrointestinal or urologic toxicities occurred in 66 with cisplatin ( 19.1 % ) and 29 with hydroxyurea ( 16.8 % ) .\
RESULTS	Delayed radiation toxicity occurred in six patients who received cisplatin ( 1.7 % ) and two who received hydroxyurea ( 1.2 % ; P = .680 ) .\
CONCLUSIONS	Cisplatin-based chemotherapy during pelvic radiation therapy improves long-term PFS and OS among locally advanced cervical cancer patients collectively and for stage IIB and III disease , individually .\
CONCLUSIONS	There was no observed increase in late toxicity with cisplatin-based chemoradiotherapy .\
\
###19633827\
OBJECTIVE	The aim of the present study was to investigate the effect of blood pressure lowering and intensive glucose control on the incidence and progression of retinopathy in type 2 diabetic patients .\
METHODS	The Action in Diabetes and Vascular Disease : Preterax and Diamicron MR Controlled Evaluation ( ADVANCE ) Retinal Measurements study , a substudy of ADVANCE , is a randomised ( using a central , computer-based procedure ) controlled 2 x 2 factorial trial comprising a double-blind comparison of blood pressure lowering with perindopril-indapamide vs placebo , and an open comparison of standard vs intensive glucose control targeting a HbA ( 1c ) of < or = 6.5 % in 1,602 diabetic patients from ADVANCE centres with access to retinal cameras conducted from 2001 to 2008 .\
METHODS	At baseline and the final visit , seven-field stereoscopic retinal photographs were taken and graded by blinded readers ( gradeable baseline and final photographs from 1,241 patients ) .\
METHODS	Progression of > or = 2 steps in the Early Treatment of Diabetic Retinopathy Study classification ( using the eye with worst grading ) was the primary outcome .\
RESULTS	Retinopathy progressed in 59 ( 4.8 % ) patients and developed in 128 ( 10.3 % ) patients over 4.1 years .\
RESULTS	Fewer patients on blood pressure-lowering treatment ( n = 623 ) experienced incidence or progression of retinopathy compared with patients on placebo ( n = 618 ) , but the difference was not significant ( OR 0.78 ; 95 % CI 0.57-1 .06 ; p = 0.12 ) .\
RESULTS	Blood pressure-lowering treatment reduced the occurrence of macular oedema ( OR 0.50 ; 95 % CI 0.29-0 .88 ; p = 0.016 ) and arteriovenous nicking compared with placebo ( OR 0.60 ; 95 % CI 0.38-0 .94 ; p = 0.025 ) .\
RESULTS	Compared with standard glucose control ( n = 611 ) , intensive glucose control ( n = 630 ) did not reduce ( p = 0.27 ) the incidence and progression of retinopathy ( OR 0.84 ; 95 % CI 0.61-1 .15 ) .\
RESULTS	Lower , borderline significant risks of microaneurysms , hard exudates and macular oedema were observed with intensive glucose control , adjusted for baseline retinal haemorrhages .\
RESULTS	These effects of the two treatments were independent and additive .\
RESULTS	Adverse events in the ADVANCE study are reported elsewhere .\
CONCLUSIONS	Blood pressure lowering or intensive glucose control did not significantly reduce the incidence and progression of retinopathy , although consistent trends towards a benefit were observed , with significant reductions in some lesions observed with both interventions .\
BACKGROUND	ClinicalTrials.gov ID no .\
BACKGROUND	NCT00145925 .\
BACKGROUND	Grants from Servier and the National Health and Medical Research Council of Australia .\
\
###20466431\
BACKGROUND	Depression is common in individuals with diabetes .\
BACKGROUND	The present study is the first randomized controlled trial to test the efficacy of omega-3 ethyl-eicosapentaenoic acid ( E-EPA ) as adjuvant to antidepressant medication in the treatment of depression in adults with diabetes mellitus .\
METHODS	In the VU University Medical Center , we conducted a 12-week , placebo-controlled , double-blind , parallel-group intervention study of E-EPA ( 1g/day ) versus placebo in 25 diabetes patients meeting DSM-IV criteria for major depressive disorder , who were already using antidepressant medication .\
METHODS	The primary outcome was severity of depressive symptoms , assessed by the Montgomery Asberg Depression Rating Scale ( MADRS ) at baseline and 12-week follow-up at two-weekly intervals .\
METHODS	Blood samples were collected at baseline and at 12-week follow-up to determine EPA levels in erythrocyte membranes .\
METHODS	Data were analyzed with ANOVA for repeated measures .\
RESULTS	Thirteen participants were randomly assigned to E-EPA ; 12 participants were given placebo .\
RESULTS	At 12-week follow-up , erythrocyte membranes from patients receiving E-EPA contained tripled levels of EPA , while no changes were noted in participants receiving placebo .\
RESULTS	In both groups , depressive symptoms significantly decreased over time ( F = 21.14 , p < 0.001 ) , yet no significant differences were found between those treated with E-EPA versus placebo ( F = 1.63 , p = 0.17 ) .\
CONCLUSIONS	Although having sufficient study power , this study had a relatively small sample size .\
CONCLUSIONS	Small effects could not be detected , and dose-dependent effects could not be studied .\
CONCLUSIONS	No evidence was found for the efficacy of adding E-EPA to antidepressants in reducing depressive symptoms in diabetic patients with co-morbid depression .\
\
###16451383\
OBJECTIVE	Tooth staining is a common side effect of chlorhexidine mouth rinses and caused by the interaction of the di-cationic antiseptic with dietary chromogens .\
OBJECTIVE	A product is now available , which claims an anti-discolouration system ( ADS ) with one clinical study in support .\
OBJECTIVE	This study in vitro aims to determine whether two ADS rinses do or do not bind dietary chromogens .\
METHODS	Optically clear acrylic specimens were cycled through human saliva ( 2 min ) , one of the three chlorhexidine rinses ( two ADS and a positive control ) ( 2 min ) or water and then soaked in tea ( 60 min ) .\
METHODS	After each cycle the optical density ( OD ) of specimens were read on a UV/visible spectrophotometer .\
METHODS	The exit point was the cycle at which OD was > 2.0 .\
RESULTS	All three rinses exceeded OD 2 at 11 cycles and there was no significant difference in staining for the ADS rinses compared with the positive control rinse .\
CONCLUSIONS	Based on extensive literature for the correlation of this test in vitro with chlorhexidine anti-plaque activity and propensity to stain in vivo these ADS rinses will have the same anti-plaque efficacy and potential to cause stain as established chlorhexidine rinse products .\
\
###11676354\
OBJECTIVE	Erythropoietin is shown to be an effective treatment for anemia in various types of cancers , however only limited studies have evaluated its benefits in advanced hormone-refractory prostate cancer ( HRPC ) .\
OBJECTIVE	This multi-center study investigated the influence of 2 different doses of epoetin beta on quality of life , hemoglobin level , need for blood transfusion , and safety , in the treatment of anemia in patients with metastatic HRPC .\
METHODS	This study randomized 180 patients to receive either epoetin beta 1000 IU or 5000 IU subcutaneously 3 times per week for 12 weeks .\
METHODS	Hemoglobin was evaluated at study start and 6 time-points during the study .\
METHODS	Quality of life ( QoL ) was assessed by the European Organization for Research and Treatment of Cancer questionnaire , QLC-C30 , before treatment start and after 6 and 12 weeks of treatment .\
METHODS	Best supportive care and blood transfusions were given , if clinically indicated .\
METHODS	Additional laboratory values and adverse events were followed for safety .\
RESULTS	Hemoglobin increased significantly ( > 20 g/l ) in 43 % in the high dose ( HD ) group and 25 % in the low dose ( LD ) group in response to treatment .\
RESULTS	Levels were significantly higher in the HD group than the LD group ( p < 0.001 ) after 8 and 12 weeks .\
RESULTS	QoL improved significantly if the increase in hemoglobin was > 20 g/l .\
RESULTS	Significantly more patients in the LD group received blood transfusions than the HD group ( p < 0.005 ) .\
RESULTS	There were no differences between the groups regarding overall quality of life and fatigue .\
RESULTS	The treatment was well tolerated in both groups .\
CONCLUSIONS	Epoetin beta is shown to be safe and effective for the treatment of anemia in many patients with HRPC .\
CONCLUSIONS	It is found to improve QoL and physical functioning , and relieve fatigue symptoms , in many of these critically ill patients .\
\
###12700625\
OBJECTIVE	To determine if it is possible to deliver a one-quarter reduction in the sodium content of bread without detection .\
METHODS	Single-blind , randomized , controlled trial .\
METHODS	The Royal North Shore Hospital in Sydney , Australia .\
METHODS	One-hundred and ten volunteers from the hospital staff that completed 94 % of scheduled assessments .\
METHODS	Six consecutive weeks of bread with usual sodium content or six consecutive weeks of bread with cumulating 5 % reductions in sodium content each week .\
METHODS	The proportion of participants reporting a difference in the salt content of the study bread from week to week .\
RESULTS	The intervention group were no more likely than the control group to report a difference in the salt content of the bread from week to week ( P = 0.8 ) .\
RESULTS	Similarly , there were no differences between randomized groups in the scores for flavour ( P = 0.08 ) or liking of the bread ( P = 0.95 ) over the study follow-up period .\
RESULTS	However , the saltiness scores recorded on a visual analogue scale did decline in the intervention group compared with the control group ( P = 0.01 )\
CONCLUSIONS	A one-quarter reduction in the sodium content of white bread can be delivered over a short time period , while maintaining consumer acceptance .\
CONCLUSIONS	Over the long term , and particularly if achieved for multiple foods , a decrease in sodium content of this magnitude would be expected to reduce population levels of blood pressure and the risks of stroke and heart attack .\
\
###16181529\
OBJECTIVE	To assess the efficacy of the Coronary Heart Disease ( CHD ) Capsules worked out by Prof. Deng -- in improving quality of life of CHD patients of qi deficiency with phlegm and blood stasis syndrome .\
METHODS	According to the WHO 's diagnosis criteria of CHD , a total of 93 stable angina patients were divided into 3 groups using the single blinded method .\
METHODS	The groups were evenly distributed into CHD Capsule treated group ( CHDC ) , isosorbide dinitrate control group ( ID ) , and Compound Prescription Danshen Droplet Pills control group ( CPDDP ) .\
METHODS	Two courses of treatment lasting for 6 months were given .\
METHODS	During the courses of treatment , the following parameters were observed : clinical symptoms of angina pectoris , ECG change , treadmill exercise test , 36 items in short form of health survey ( SF-36 ) and Seattle Angina Questionnaire ( SAQ ) scale .\
RESULTS	After 6 months of treatment , all the three groups showed good curative effect in angina pectoris , ECG and treadmill exercise test , differences between them had no statistical significance .\
RESULTS	The CHDC group showed a better result in nitro-glycerine stopping or alleviation rate and in improving symptoms than the other groups ( P < 0.05 ) .\
RESULTS	The general health , vitality , role-emotional , mental health and reported health transition in the CHDC group were significantly better than those in the control groups ( P < 0.05 ) .\
RESULTS	The scores in physiological functioning role , physiological function and pain alleviation were not different among the three groups .\
CONCLUSIONS	Prof. DENG Tie-tao 's CHDC is effective in treating CHD with qi deficiency , phlegm and blood stasis and also in improving the quality of life .\
CONCLUSIONS	CHDC is more suitable to be used in long-term treatment than isosorbide dinitrate .\
CONCLUSIONS	The SF-36 and SAQ can be used to appraise the curative effect of traditional Chinese medicine agents for CHD angina pectoris .\
\
###18197974\
BACKGROUND	The primary objective of this study was to investigate if supplementary lactobacilli treatment could improve the initial cure rate after vaginal clindamycin therapy , and secondly , if lactobacilli as repeated adjunct treatment during 3 menstrual cycles could lengthen the time to relapse after initial cure .\
METHODS	Women ( n = 100 ) with bacterial vaginosis diagnosed by Amsel criteria were after informed consent offered vaginal clindamycin therapy followed by vaginal gelatine capsules containing either 109 freeze-dried lactobacilli or identical placebo capsules for 10 days during 3 menstrual cycles in a double-blind , randomized , placebo-controlled trial .\
RESULTS	The initial intent to treat ( ITT ) analysis for the one-month cure rate was 64 % in the lactobacilli group and 78 % in the placebo group ( p > 0.05 ) .\
RESULTS	However , any patient with missing or unclassified smears at the initial visit who continued the study and whose next smear indicated a cure was included in the cured group ; the study also excluded two of the patients in the lactobacilli group who reported that they did not take any vaginal capsules .\
RESULTS	With consideration to these population changes , the initial cure rate would be 77 % in the lactobacilli group .\
RESULTS	The 76 cured women were followed for 6 menstrual cycles or until relapse within that time span .\
RESULTS	At the end of the study , 64.9 % ( 24/37 ) of the lactobacilli treated women were still BV-free compared to 46.2 % ( 18/39 ) of the placebo treated women .\
RESULTS	Comparison of the two groups regarding `` Time from cure to relapse '' was statistically significant ( p = 0.027 ) in favour of the lactobacilli treatment .\
RESULTS	Adjuvant therapy with lactobacilli contributed significantly to avoidance of relapse with a proportional Hazard Risk ratio ( HR ) of 0.73 ( 0.54-0 .98 ) ( p < 0.05 )\
CONCLUSIONS	The study shows that supplementary treatment combining two different strains of probiotic lactobacilli does not improve the efficacy of BV therapy during the first month of treatment , but for women initially cured , adjunct treatment of lactobacilli during 3 menstrual cycles lengthens the time to relapse significantly in that more women remained BV free at the end of the 6-month follow up .\
BACKGROUND	ISRCTN62879834 .\
\
###11176553\
OBJECTIVE	The objective of the study was to evaluate the effectiveness of 2 educational strategies aimed at improving prescribing standards in primary care .\
METHODS	A pragmatic controlled trial was designed ; the study population included general and family practitioners in Galicia ( northwestern Spain ) divided into 3 study groups : a one-to-one education group ( n = 98 ) , a by-group education group ( n = 92 ) , and a control group ( n = 405 ) .\
METHODS	The educational intervention included explicit recommendations for selecting nonsteroidal anti-inflammatory drugs ( NSAIDs ) for inflammation signs .\
METHODS	Some of the subjects were given reminders .\
METHODS	Mixed-effect linear models were applied to data analysis .\
METHODS	Analyses were done by intention-to-treat .\
METHODS	The dependent variable is a rate with a numerator that is the number of prescribed units of the NSAIDs recommended during intervention ; the denominator is the total number of prescribed units of the NSAID total .\
RESULTS	One-to-one education obtained an average prescribing behavior improvement of 6.5 % ( P < 0.001 ) in the 9 months after intervention .\
RESULTS	In the education group , the average improvement was 2.4 % ( P < 0.05 ) for the same period .\
RESULTS	Statistically significant differences were observed between the group intervention and one-to-one groups .\
RESULTS	The reminder increased significantly the effectiveness of the one-to-one intervention .\
CONCLUSIONS	A single , short educational session to primary care doctors can improve their prescribing standards during long periods of > or = 9 months .\
CONCLUSIONS	Of the 2 strategies followed in the trial , one-to-one education has shown to be the most effective .\
CONCLUSIONS	Results also show that the effectiveness of these interventions increases when presented together with written material .\
\
###24761877\
BACKGROUND	To evaluate efficacy and side effects of glycididazole sodium ( CMNa ) combined with chemotherapy ( cisplatin plus 5-FU/folic acid , PLF ) and radiotherapy in treating patients with locally advanced nasopharyngeal carcinoma .\
METHODS	Patients with III ~ IV stage nasopharyngeal carcinoma ( NPC ) , were randomly divided into treatment group ( 46 patients ) and control group ( 45 patients ) .\
METHODS	Both groups received radiotherapy concomitant with PLF chemotherapy .\
METHODS	The treatment group at the same time was given CMNa ( 800 mg/m2 before radiotherapy ) , by l h intravenous drip , three times a week .\
RESULTS	When the dose of radiation was over 60 Gy , complete response rates of nasopharyngeal tumor and lymph node metastases in treatment group were significantly higher than in the control group ( 93.5 % vs 77.8 % ; 89.1 % vs 93.5 % , p < 0.05 ) .\
RESULTS	Three months after radiotherapy , complete response rate of nasopharynx cancer and lymph node metastases in treatment group was both 97.8 % , again higher than in the control group ( 84.4 % and 82.2 % ) ( p < 0.05 ) .\
RESULTS	In the treatment group , 1 , 3 , 5 year disease-free survival rates were 95.7 % , 86.7 % and 54.5 % ; and in control group , the corresponding disease-free survival rates were 93.3 % , 66.2 % and 38.6 % , respectively , the difference being statistically significant ( log-rank = 5.887 , p = 0.015 ) .\
RESULTS	One , 3 , 5 year overall survival rates in two groups of patients were 97.8 % , 93.5 % , 70.4 % and 95.5 % , 88.07 % , 48.4 % , respectively , again with a statistically significant difference ( log-rank = 6.470 , p = 0.011 ) .\
RESULTS	Acute toxicity and long-term radiotherapy related toxicity in the two groups did not differ ( p > 0.05 ) .\
CONCLUSIONS	Glycididazole sodium could improve curative effects without increasing adverse reactions when treating patients with locally advanced nasopharyngeal carcinoma .\
\
###8636523\
OBJECTIVE	To compare the effects of pressure support ventilation ( PSV ) delivered at the same level by three different ventilators on patients ' work of breathing ( WOB ) , breathing pattern and gas exchange .\
METHODS	Prospective , self-controlled clinical study .\
METHODS	Intensive care unit of a tertiary university hospital .\
METHODS	Nine intubated adult patients during weaning from mechanical ventilation .\
METHODS	Patients were randomly connected to one of three ventilators : the Siemens Servo 900 C ( SC ) , the Ohmeda CPU 1 ( CPU ) , and the Engstrm Erica ( EE ) during both zero cmH2O PSV and 15 cmH2O PSV .\
RESULTS	During zero PSV , there was no significant difference in terms of WOB , VT , VE , or auto-PEEP among the three ventilators , although there was a trend towards higher levels of WOB with EE .\
RESULTS	During 15 cmH2O PSV , WOB was significantly less with SC than with EE or CPU ( 0.47 + / - 0.48 J/l for SC , 1.0 + / - 0.48 for EE and 0.78 + / - 0.51 for CPU1 , p = 0.003 ) .\
RESULTS	WOB was 64 % less than at zero PSV with SC but only 38 % less with EE .\
RESULTS	This was associated with a different pressurization shape , as assessed by the interior surface of Paw-VT loops ( 1.23 + / - 0.09 J/l for SC , 0.9 + / - 0.02 for EE , and 0.79 + / - 0.18 for CPU ; p < 0.001 ) .\
RESULTS	At 15 cmH2O PSV , auto-PEEP was significantly lower with SC than with EE ( 1.7 + / - 2.1 cmH2O for SC , 4.7 + / - 3.6 for EE , and 2.8 + / - 0.3 for CPU ; p = 0.04 ) .\
RESULTS	External expiratory resistances , in cmH2O/l/s , were significantly higher with EE than with CPU or SC ( 12.9 + / - 3.2 EE , 7.5 + / - 2.4 CPU , 5.9 + / - 0.5 SC ; p < 0.001 ) .\
CONCLUSIONS	During PSV , the different working principles of different mechanical ventilators profoundly affect patient 's WOB .\
CONCLUSIONS	Among the various factors , velocity of pressurization of PSV may play a role in its efficacy in unloading the respiratory muscles .\
\
###14742346\
OBJECTIVE	To evaluate the efficacy of two internet interventions for community-dwelling individuals with symptoms of depression -- a psychoeducation website offering information about depression and an interactive website offering cognitive behaviour therapy .\
METHODS	Randomised controlled trial .\
METHODS	Internet users in the community , in Canberra , Australia .\
METHODS	525 individuals with increased depressive symptoms recruited by survey and randomly allocated to a website offering information about depression ( n = 166 ) or a cognitive behaviour therapy website ( n = 182 ) , or a control intervention using an attention placebo ( n = 178 ) .\
METHODS	Change in depression , dysfunctional thoughts ; knowledge of medical , psychological , and lifestyle treatments ; and knowledge of cognitive behaviour therapy .\
RESULTS	Intention to treat analyses indicated that information about depression and interventions that used cognitive behaviour therapy and were delivered via the internet were more effective than a credible control intervention in reducing symptoms of depression in a community sample .\
RESULTS	For the intervention that delivered cognitive behaviour therapy the reduction in score on the depression scale of the Center for Epidemiologic Studies was 3.2 ( 95 % confidence interval 0.9 to 5.4 ) .\
RESULTS	For the `` depression literacy '' site ( BluePages ) , the reduction was 3.0 ( 95 % confidence interval 0.6 to 5.2 ) .\
RESULTS	Cognitive behaviour therapy ( MoodGYM ) reduced dysfunctional thinking and increased knowledge of cognitive behaviour therapy .\
RESULTS	Depression literacy ( BluePages ) significantly improved participants ' understanding of effective evidence based treatments for depression ( P < 0.05 ) .\
CONCLUSIONS	Both cognitive behaviour therapy and psychoeducation delivered via the internet are effective in reducing symptoms of depression .\
\
###16895948\
BACKGROUND	Hyperglycemia in patients undergoing coronary artery bypass grafting ( CABG ) is associated with adverse outcome .\
BACKGROUND	Although insulin infusion strategies are increasingly used to improve outcome , a pathophysiological rationale is currently lacking .\
BACKGROUND	The present study was designed to quantify the effects of a perioperative hyperinsulinemic normoglycemic clamp on the neurohumoral stress response during CABG .\
METHODS	Forty-four nondiabetic patients , scheduled for elective CABG , were randomized to either a control group ( n = 22 ) receiving standard care or to a clamp group ( n = 22 ) receiving additionally a perioperative hyperinsulinemic ( regular insulin at a fixed rate of 0.1 IU.kg ( -1 ) .\
METHODS	h ( -1 ) ) normoglycemic ( plasma glucose between 3.0 and 6.0 mmol.liter ( -1 ) ) clamp during 26 h.\
METHODS	We measured the endocrine response of the hypothalamus-pituitary-adrenal ( HPA ) axis , the sympathoadrenal axis , and glucagon , as well as plasma glucose and insulin at regular intervals from the induction of anesthesia at baseline through the end of the second postoperative day ( POD ) .\
RESULTS	There were no differences in clinical outcome between the groups .\
RESULTS	In the control group , hyperglycemia developed at the end of surgery and remained present until the final measurement point on POD2 , whereas plasma insulin levels remained unchanged until the morning of POD1 .\
RESULTS	In the intervention group , normoglycemia was well maintained during the clamp , whereas insulin levels ranged between 600 and 800 pmol.liter ( -1 ) .\
RESULTS	In both groups , plasma ACTH and cortisol increased from 6 h after discontinuation of cardiopulmonary bypass onward .\
RESULTS	However , during the clamp period , a marked reduction in the HPA axis response was found in the intervention group , as reflected by a 47 % smaller increase in area under the curve in plasma ACTH ( P = 0.035 ) and a 27 % smaller increase in plasma cortisol ( P = 0.002 ) compared with the control group .\
RESULTS	Compared with baseline , epinephrine and norepinephrine increased by the end of the clamp interval until POD2 in both groups .\
RESULTS	Surprisingly , the area under the curve of epinephrine levels was 47 % higher ( P = 0.026 ) after the clamp interval in the intervention group as compared with the control group .\
CONCLUSIONS	A hyperinsulinemic normoglycemic clamp during CABG delays and attenuates the HPA axis response during the first 18 h of the myocardial reperfusion period , whereas after the clamp , plasma epinephrine is higher .\
CONCLUSIONS	The impact of delaying cortisol responses on clinical outcome of CABG remains to be elucidated .\
\
###21469973\
OBJECTIVE	Drospirenone is a novel progestogen that , combined with 17-estradiol , reduces the frequency and severity of menopausal vasomotor symptoms ( VMS ) in different populations .\
OBJECTIVE	This double-blind , multicenter study compared the efficacy , safety and tolerability of 2 mg drospirenone/1 mg estradiol ( DRSP/E2 ) vs. placebo in Chinese postmenopausal women with moderate to severe VMS .\
METHODS	Women , aged 45-65 years , were randomized to DRSP/E2 ( n = 183 ) or placebo ( n = 61 ) once daily for four 28-day cycles .\
METHODS	Changes in the frequency and severity of hot flushes were analyzed as primary variables , together with other climacteric and urogenital symptoms , clinical global improvement , adverse events and physical/gynecological parameters .\
RESULTS	Relative changes in numbers of hot flushes/week were -80.4 % for DRSP/E2 vs. -51.9 % for placebo ( treatment difference -28.5 % , p < 0.0001 ) .\
RESULTS	There were trends toward a greater reduction in severity of hot flushes with DRSP/E2 treatment .\
RESULTS	Patients treated with DRSP/E2 were more often free from sweating episodes ( p < 0.0001 ) and vaginal dryness ( p = 0.0008 ) .\
RESULTS	Other climacteric symptoms , including nervousness and pollakisuria , followed a trend of greater response with DRSP/E2 .\
RESULTS	Similar to other combination HRT regimens , DRSP/E2 increased occurrences of bleeding , but these decreased over time .\
RESULTS	Adverse events in patients treated with DRSP/E2 were mostly mild to moderate and withdrawal rates were low .\
CONCLUSIONS	Daily treatment of postmenopausal Chinese women with DRSP/E2 for 16 weeks significantly reduced the incidence of hot flushes and demonstrated advantages vs. placebo for other climacteric symptoms .\
CONCLUSIONS	These results indicate that DRSP/E2 is effective , safe and well tolerated in postmenopausal Chinese women .\
\
###22580040\
OBJECTIVE	This study was to investigate the gastrokinetic activity of Morinda citrifolia aqueous fruit extract ( AFE ) in human subjects by examining the GI absorption of ranitidine , a putative indicator of GI motility and to elucidate its possible gastrokinetic mechanism of action in rats .\
METHODS	The single-dose , randomized , open-label and 2-period crossover study was performed on 20 Thai healthy volunteers with a washout period of 14 day between the doses .\
METHODS	AFE or drinking water was administered orally 30 min prior to a single oral administration of ranitidine ( 300 mg ) .\
METHODS	Blood samples were collected over a 12 h period after drug administration and the pharmacokinetic parameters of ranitidine were calculated .\
METHODS	The gastrokinetic mechanism of action of AFE was elucidated by measurement of its contractile response on the isolated rat gastric fundus strip .\
RESULTS	The area under the plasma ranitidine concentration-time curve and the maximal plasma ranitidine concentration were significantly increased after pretreatment with AFE ( p = 0.001 ) .\
RESULTS	The plasma ranitidine concentrations were significantly greater at 30-120 min after its administration .\
RESULTS	AFE produced a definite contractile response of a rat gastric fundus strip with a dose dependency .\
RESULTS	Scopoletin at the same equivalent dose present in AFE elicited a concentration-dependent contraction that amounted to 45 % of the maximal response to AFE .\
RESULTS	The contractile response of both AFE and scopoletin was mediated through the 5-HT ( 4 ) receptor .\
CONCLUSIONS	AFE has a unique gastrokinetic activity in enhancement of the rate and the extent of ranitidine absorption .\
CONCLUSIONS	The underlying mechanism can be attributed , at least in part , to the ability of its active component : scopoletin to stimulate the 5-HT ( 4 ) receptor .\
\
###17126116\
BACKGROUND	Development of tricuspid regurgitation after orthotopic heart transplantation can cause heart failure along with renal and hepatic impairment and portends a poor prognosis .\
BACKGROUND	If tricuspid regurgitation causes significant symptoms , tricuspid valve repair or replacement is often required .\
BACKGROUND	This study was designed to study the effects of prophylactic tricuspid valve annuloplasty ( TVA ) during orthotopic heart transplantation on long-term survival , renal function , and amount of tricuspid regurgitation .\
METHODS	Between April 1997 and March 1998 , 60 patients ( aged 18 to 70 years ; 22 female ) randomly received either standard bicaval orthotopic heart transplantation ( group STD ; n = 30 ) or bicaval orthotopic heart transplantation with DeVega TVA ( group TVA ; n = 30 ) .\
METHODS	Tricuspid valve annuloplasty was performed on the donor heart before implantation using pledgeted 2-0 polypropylene and sized to an annulus of 29 mm .\
METHODS	Echocardiographic measurements , laboratory values , and hemodynamics were obtained prospectively and reviewed by an independent data analyst .\
RESULTS	Follow-up of patients as of December 2003 was complete .\
RESULTS	Although there was a perioperative mortality advantage in group TVA , there was no difference between groups in long-term survival .\
RESULTS	At the end of the study , however , there was a statistical difference ( group STD versus group TVA , p < 0.05 ) with regard to cardiac mortality ( 7 of 30 versus 3 of 30 ) , average amount of tricuspid regurgitation ( 1.5 + / - 1.3 versus 0.5 + / - 0.4 ) , percentage of patients with 2 + or greater tricuspid regurgitation ( 34 % versus 0 % ) , serum creatinine ( 2.9 + / - 2.0 versus 1.8 + / - 0.7 ) , and difference in serum creatinine over baseline ( 2.0 + / - 2.1 versus 0.7 + / - 0.8 ) .\
CONCLUSIONS	Prophylactic DeVega TVA of the donor heart is durable and decreases the incidence of cardiac-related mortality and tricuspid regurgitation after orthotopic heart transplantation .\
CONCLUSIONS	In addition , there is improved protection of renal function .\
CONCLUSIONS	Considering the ease and safety of TVA and its advantages , it should be performed as a routine adjunct to orthotopic heart transplantation .\
\
###12421996\
OBJECTIVE	To compare the efficacy and safety of intra-articular injections of two different hyaluronan preparations and placebo in patients with knee osteoarthritis .\
METHODS	In a randomized , patient - and observer-blind , placebo-controlled and multicentre trial with parallel groups , 210 patients , aged 60 yr or above , with knee osteoarthritis were included in a per protocol analysis .\
METHODS	The patients were treated with three injections , once weekly , of either native high-molecular-weight hyaluronan ( Artzal ( ( R ) ) ) or cross-linked hyaluronan ( Synvisc ( ( R ) ) ) or with placebo and were followed for 52 weeks .\
METHODS	The primary efficacy measures were weight-bearing pain during study weeks 0-26 and the duration of clinical benefit measured with Kaplan-Meier survival analysis for weeks 0-52 .\
METHODS	The secondary outcome measures were resting and maximum pain , Lequesne index , WOMAC ( Western Ontario and McMaster University Osteoarthritis Index ) and SF-36 ( Medical Outcomes Study Short Form Health Survey ) scores .\
RESULTS	The intra-articular injections produced a significant reduction in weight-bearing pain , resting pain , maximum pain and Lequesne and WOMAC scores after 26 weeks .\
RESULTS	There were no significant differences in outcome between any of the three study groups during the first 26 weeks .\
RESULTS	In direct comparison against placebo for weeks 0-52 , neither hyaluronan treatment ( Artzal or Synvisc ) showed a significantly longer duration of clinical benefit than placebo .\
RESULTS	However , when data for the two hyaluronan-treated groups were pooled , treatment with hyaluronan had a significantly longer duration of benefit compared with placebo ( P = 0.047 ) .\
CONCLUSIONS	Patients with knee osteoarthritis who were treated by injection into the knee of either of two hyaluronan preparations or placebo showed clinical improvement during the first 26 weeks of treatment , though neither hyaluronan preparation gave a longer duration of clinical benefit than placebo .\
CONCLUSIONS	However , when data for the two hyaluronan treatments were pooled , there was a significantly longer duration of clinical benefit for hyaluronan treatment than for placebo .\
\
###18199572\
OBJECTIVE	The efficacy of preventive pacing algorithms ( PPA ) and anti-tachycardia pacing ( ATP ) in reducing atrial fibrillation ( AF ) burden remains controversial .\
OBJECTIVE	The aim of this study was to assess whether ATP on top of PPA decreases AF burden .\
RESULTS	A series of 199 consecutive patients , with conventional indications for pacing , and documented AF , received a DDDR ( rate adaptive dual chamber pacemaker ) pacemaker with ATP capabilities ( AT 500 Medtronic ) .\
RESULTS	After 3 months of conventional DDDR pacing at 70 b.p.m. , AF burden was analysed .\
RESULTS	If patients had > 30 min/week of AF , they were randomized to PPA or to PPA+ATP for 3 months ( period 1 ) .\
RESULTS	They were then crossed to the alternative therapy ( period 2 ) and followed three additional months with a 1-month wash out period in-between .\
RESULTS	A group of 85 patients were randomized .\
RESULTS	Mean age 68 + / - 8 years , 61 % men .\
RESULTS	Both groups showed a significant decrease in AF burden at the end of period 1 ( 64 and 81 % , respectively ) .\
CONCLUSIONS	Atrial pacing with PPA decreases AF burden in patients with pacing indication .\
CONCLUSIONS	We did not observe a further decrease in AF burden or in the number of episodes when adding ATP on top of PPA .\
\
###20142183\
OBJECTIVE	OAT randomised patients with an occluded infarct artery three to 28 days after myocardial infarction ( MI ) .\
OBJECTIVE	The study demonstrated that PCI did not reduce the occurrence of the primary composite endpoint of death , re-MI , and New York Heart Association class IV heart failure in comparison with patients assigned to optimal medical therapy alone ( MED ) .\
OBJECTIVE	In view of prior literature in similar cohorts showing fewer sudden cardiac deaths and less left ventricular ( LV ) remodelling , but excess re-MI with PCI , causes of death were analysed in more detail .\
RESULTS	Stepwise Cox regression was used to examine baseline variables associated with causes of death .\
RESULTS	The immediate and primary cause of death did not differ between 1,101 PCI and 1,100 MED patients .\
RESULTS	One-year cardiovascular death rates were 3.8 % for the PCI group , and 3.7 % for the MED group , and 0.9 % per year for the next four years in both groups .\
RESULTS	Five of six cases of cardiac rupture occurred in patients undergoing PCI .\
CONCLUSIONS	In stable post-MI patients with occlusion of the infarct-related artery , PCI did not change the rate or cause of death .\
CONCLUSIONS	The observation that the majority of cardiac ruptures occurred in patients undergoing PCI deserves further investigation .\
\
###14575972\
BACKGROUND	Type 2 diabetes shows evidence of underlying heterogeneity .\
BACKGROUND	No studies have assessed whether different causes for diabetes change the response to oral hypoglycaemic therapy .\
BACKGROUND	In a few cases , patients with diabetes caused by mutations in the hepatocyte nuclear factor 1alpha ( HNF-1alpha ) gene have been described as sensitive to the hypoglycaemic effects of sulphonylureas .\
BACKGROUND	We aimed to see whether the glycaemic response to the sulphonylurea gliclazide and the biguanide metformin differed in HNF-1alpha diabetes and type 2 diabetes , and to investigate the mechanism for differences in sulphonylurea sensitivity .\
METHODS	We did a randomised crossover trial of glicazide and metformin in 36 patients , either with diabetes caused by HNF-1alpha mutations or type 2 diabetes , who were matched for body-mass index and fasting plasma glucose .\
METHODS	The primary outcome was reduction in fasting plasma glucose .\
METHODS	Analysis was by intention to treat .\
METHODS	We assessed possible mechanisms for sulphonylurea sensitivity through insulin sensitivity , insulin secretory response to glucose and tolbutamide , and tolbutamide clearance .\
RESULTS	Patients with HNF-1alpha diabetes had a 5.2-fold greater response to gliclazide than to metformin ( fasting plasma glucose reduction 4.7 vs 0.9 mmol/L , p = 0.0007 ) and 3.9-fold greater response to gliclazide than those with type 2 diabetes ( p = 0.002 ) .\
RESULTS	Patients with HNF-1alpha diabetes had a strong insulin secretory response to intravenous tolbutamide despite a small response to intravenous glucose , and were more insulin sensitive than those with type 2 diabetes .\
RESULTS	Sulphonylurea metabolism was similar in both patient groups .\
CONCLUSIONS	The cause of hyperglycaemia changes the response to hypoglycaemic drugs ; HNF-1alpha diabetes has marked sulphonylurea sensitivity .\
CONCLUSIONS	This pharmacogenetic effect is consistent with models of HNF-1alpha deficiency , which show that the beta-cell defect is upstream of the sulphonylurea receptor .\
CONCLUSIONS	Definition of the genetic basis of hyperglycaemia has implications for patient management .\
\
###23081843\
OBJECTIVE	Cholangitis is the most common infectious complication of ERCP .\
OBJECTIVE	In vitro studies showed that addition of aminoglycosides to contrast medium was effective in reducing cholangitis but the results of clinical trials are conflicting .\
OBJECTIVE	We studied the effect of adding gentamicin to contrast medium in reducing the rate of post-ERCP cholangitis in patients with non-calculous obstructive jaundice .\
METHODS	All patients with non-calculous obstructive jaundice who underwent endoscopic biliary stenting at the Shariati Hospital , Tehran , between December 2009 and October 2010 were enrolled in the study .\
METHODS	Gentamicin ( 10mg ) or distilled water was added to each 10cc contrast medium during ERCP .\
METHODS	Intravenous antibiotics were administered before and after the procedure in all patients .\
METHODS	After ERCP and stent deployment , patients were followed for 72h for symptoms and signs of cholangitis .\
RESULTS	A total of 114 patients were eligible for the study .\
RESULTS	Of these , 57 patients were included in each group .\
RESULTS	Cholangiocarcinoma was the most prevalent diagnosis .\
RESULTS	The obstruction was relieved in all patients by stenting .\
RESULTS	Five patients in each group ( 8.8 % ) developed cholangitis .\
RESULTS	There was no significant difference in the incidence of cholangitis between the two groups ( p = 1.000 ) .\
CONCLUSIONS	With adequate drainage of the obstructed biliary tract by proper stenting , adding gentamicin to contrast media had no significant effect on incidence of post-ERCP cholangitis .\
\
###16773549\
OBJECTIVE	The disease management programme for diabetes mellitus type 2 ( DMP ) is joined by many General Practitioners .\
OBJECTIVE	Aim of the study is to compare patients included in this programme with patients not included and to explore reasons for the selection .\
METHODS	10 GPs in Hamburg participated .\
METHODS	From each patient list 10 participants in the DMP and the same number of non-participants were randomly selected .\
METHODS	HbA1c before start of the programme , presence of insulin therapy , comorbidity and language skills were documented .\
METHODS	GPs reported their estimation of the compliance and their reasoning in the selection process .\
METHODS	The hypothesis for the primary endpoint was : Diabetics not included have a worse HbA1c value than those included in the DMP .\
RESULTS	The hypothesis was not confirmed .\
RESULTS	In both groups similarly good HbA1c values were observed ( 7.0 in DMP participants , 7.3 in non-participants ) .\
RESULTS	The included participants differed from those not included with respect to age ( statistically significantly younger ) and a better compliance .\
RESULTS	In the subgroup of patients younger than 70 years the patients included have a better HbA1c and get insulin more frequently ( both n. s. ) .\
CONCLUSIONS	One part of the patients seems to be not included into the DMP for good reasons .\
CONCLUSIONS	Two questions should be further evaluated : To what extent are patients included although they already have a good metabolic situation ?\
CONCLUSIONS	And to what extent are patients with a poor compliance not included , although they might benefit from participation ?\
\
###26016866\
BACKGROUND	The consumption of citrus fruits is associated with health benefits .\
BACKGROUND	However , clinical data regarding the effects of grapefruit flavanone consumption on vascular function are lacking .\
OBJECTIVE	The objective of the present study was to address the role of flavanones in the long-term effects induced by grapefruit juice ( GFJ ) consumption on vascular function in healthy postmenopausal women .\
METHODS	Forty-eight healthy postmenopausal women aged 50-65 y within 3-10 y since menopause , a body mass index ( in kg/m ( 2 ) ) of 19-30 , and a waist size > 88 cm completed this double-blind , randomized , controlled , crossover trial .\
METHODS	These volunteers were randomly assigned to consume 340 mL GFJ/d , providing 210 mg naringenin glycosides , or a matched control drink without flavanones for 6 mo each , with a 2-mo washout between beverages .\
METHODS	The primary endpoint was the assessment of endothelial function in the brachial artery by using flow-mediated dilation .\
METHODS	Blood pressure , arterial stiffness , and endothelial function in the peripheral arterial bed were also evaluated as indicators of vascular function .\
METHODS	These measurements and blood collection for clinical biochemical markers were performed in overnight-fasted subjects before and after the 6-mo treatment periods .\
RESULTS	The mean SD carotid-femoral pulse wave velocity , which reflects central aortic stiffness , was statistically significantly lower after consumption of GFJ ( 7.36 1.15 m/s ) than after consumption of the matched control drink without flavanones ( 7.70 1.36 m/s ) , with a P value of 0.019 for the treatment effect .\
RESULTS	Endothelial function in macro - and microcirculation , blood pressure , anthropometric measures , glucose metabolism , and biomarkers of inflammation and oxidative stress were not affected by the intervention .\
CONCLUSIONS	Regular GFJ consumption by middle-aged , healthy postmenopausal women is beneficial for arterial stiffness .\
CONCLUSIONS	This effect may be related to flavanones present in grapefruit .\
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01272167 .\
\
###21606190\
OBJECTIVE	To control postprandial hyperglycemia in insulin-treated type 2 diabetic patients , prandial therapy with regular human insulin ( HI ) or fast acting insulin analogs is used .\
OBJECTIVE	Postprandial hyperglycemia seems to be reduced more effectively with insulin analogs than with normal insulin , but there are no data concerning the effect on lipolysis or pancreatic insulin and proinsulin secretion of normal insulin in comparison to insulin analogs .\
METHODS	We included 13 patients with type 2 diabetes mellitus ( age 62.210.3 years ) with preexisting insulin therapy in this crossover , prospective , open-labeled , randomized trial comparing regular HI with insulin aspart ( IA ) in the setting of a standardized breakfast and a standardized lunch 4h later .\
METHODS	Blood samples for determination of glucose , free fatty acids ( FFA ) , triglycerides , C-peptide , and intact proinsulin were drawn during fasting and every 30min until 4h after the second test meal .\
METHODS	Statistical analysis was performed with ANOVA for repeated measurements and paired Student 's t-test .\
RESULTS	The mean increase in blood glucose was significantly lower after IA ( 24.1816.33 vs 34.9229.07 mg/dl , P = 0.02 ) compared with HI .\
RESULTS	Both therapies reduced FFA ; however , the mean reduction was significantly higher after IA than after HI ( -0.470.16 vs -0.350.15 mol/l , P < 0.001 ) .\
RESULTS	The mean increase in intact proinsulin was significantly lower after IA than after HI ( 10.535 vs 15.206.83 pmol/l , P < 0.001 ) .\
RESULTS	No differences were observed in the C-peptide levels between the two groups .\
CONCLUSIONS	In the setting of two consecutive meals , IA reduces lipolysis and proinsulin secretion more effectively than HI .\
\
###19520981\
OBJECTIVE	The results of the Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction ( S-ACCESS ) , a randomized double-blind study of sarpogrelate ( selective 5-HT ( 2A ) receptor antagonist ) versus aspirin in 1510 Japanese patients , have been reported .\
OBJECTIVE	But S-ACCESS failed to demonstrate noninferiority of sarpogrelate to aspirin for preventing the recurrence of cerebral infarction .\
OBJECTIVE	Here we compare the characteristics of sarpogrelate and aspirin in various subgroups .\
METHODS	Subgroups were predefined from patients ' baseline characteristics .\
METHODS	Hazard ratio ( HR ) and 95 % confidence interval ( CI ) for sarpogrelate versus aspirin were calculated for primary ( cerebral infarction ) and secondary ( serious vascular events ) end points .\
METHODS	Interactions between treatment effects and subgroup variables were examined by post hoc analysis .\
RESULTS	No significant difference in outcome between sarpogrelate and aspirin was found across multiple predefined subgroups .\
RESULTS	In post hoc analysis , a qualitative treatment interaction with diabetes mellitus was detected ( P = 0.166 for recurrence of cerebral infarction ; P = 0.098 for serious vascular events ) .\
RESULTS	HR for the recurrence of cerebral infarction with sarpogrelate versus that with aspirin was 0.87 ( 95 % CI : 0.48 to 1.60 ) in diabetic patients and 1.51 ( 95 % CI : 0.98 to 2.31 ) in nondiabetic patients .\
RESULTS	For serious vascular events , the corresponding HRs were 0.73 ( 95 % CI : 0.42 to 1.25 ) and 1.28 ( 95 % CI : 0.89 to 1.83 ) .\
CONCLUSIONS	No specific baseline characteristic resulting in a significant difference between the effects of sarpogrelate and aspirin was identified .\
CONCLUSIONS	Aspirin was superior in most subgroups , except diabetics .\
CONCLUSIONS	Sarpogrelate may be a useful treatment option for Japanese patients with diabetes .\
\
###12759801\
BACKGROUND	MDMA ( ecstasy ; +3,4 - methylenedioxymethamphetamine ) damages brain serotonin ( 5-HT ) neurons and , in non-human primates , a loss of various 5-HT axonal markers persists for several years .\
BACKGROUND	This raises the question of whether long lasting effects occur in human beings that persist even after they have stopped using MDMA .\
OBJECTIVE	We therefore assessed the effects of an indirect 5-HT manipulation on functions thought to be affected by MDMA use in people who had stopped using MDMA ( ex-users ) compared with continuing users and non-users .\
METHODS	Ninety-six participants were recruited : 32 ex-users who had stopped using MDMA for > 1 year ( mean , 2.4 years ) ; 32 current users and 32 polydrug controls who had never used MDMA but were matched with ex-users and controls on cannabis use and pre-morbid IQ .\
METHODS	Participants were given an amino acid mixture that contained either no tryptophan ( T - ) or augmented tryptophan ( T + ) and assessed before and 5 h after the drink on measures of cognitive function and mood .\
RESULTS	T + and T - produced plasma tryptophan augmentation and depletion , respectively , in all three groups .\
RESULTS	Ex-users ' plasma tryptophan levels in response to T + were significantly higher than other groups .\
RESULTS	Ex-users ' performance on a delayed prose recall task improved after T + and lessened after T - .\
RESULTS	Changes in ex-users ' free plasma tryptophan levels correlated highly ( r = -0.9 ) with their baseline performance on immediate and delayed prose recall ; change in total plasma tryptophan correlated ( r = -0.81 ) with delayed recall .\
RESULTS	Further , total baseline plasma tryptophan correlated with number of years they had used MDMA before quitting .\
RESULTS	Baseline differences between groups were found on learning , working memory , aggression and impulsivity .\
RESULTS	T - did not produce differential effects in the three groups .\
CONCLUSIONS	Our results suggest that prolonged abstinence from MDMA might be associated with altered tryptophan metabolism .\
CONCLUSIONS	Ex-users showing the poorest memory function at baseline were also those who metabolised least tryptophan .\
CONCLUSIONS	These findings may reflect pre-morbid differences in 5-HT function of those who stop using this drug or consequences of MDMA use that emerge after abstention .\
CONCLUSIONS	Aggression is also associated with MDMA use and subsequent abstinence .\
\
###16223399\
BACKGROUND	The addition of intrathecal ( IT ) magnesium to spinal fentanyl prolongs the duration of spinal analgesia for vaginal delivery .\
BACKGROUND	In this prospective , randomized , double-blind , controlled study , we investigated the effect of adding IT magnesium sulphate to bupivacaine-fentanyl spinal anaesthesia .\
METHODS	One hundred and two ASA I or II adult patients undergoing lower extremity surgery were recruited .\
METHODS	They were randomly allocated to receive 1.0 ml of preservative-free 0.9 % sodium chloride ( group S ) or 50 mg of magnesium sulphate 5 % ( 1.0 ml ) ( group M ) following 10 mg of bupivacaine 0.5 % plus 25 microg of fentanyl intrathecally .\
METHODS	We recorded the following : onset and duration of sensory block , the highest level of sensory block , the time to reach the highest dermatomal level of sensory block and to complete motor block recovery and the duration of spinal anaesthesia .\
RESULTS	Magnesium caused a delay in the onset of both sensory and motor blockade .\
RESULTS	The highest level of sensory block was significantly lower in group M than in group S at 5 , 10 and 15 min ( P < 0.001 ) .\
RESULTS	The median time to reach the highest dermatomal level of sensory block was 17 min in group M and 13 min in group S ( P < 0.05 ) .\
RESULTS	The mean degree of motor block was also lower in group M at 5 , 10 and 15 min ( P < 0.001 ) .\
RESULTS	The median duration of spinal anaesthesia was longer in group M ( P < 0.001 ) .\
CONCLUSIONS	In patients undergoing lower extremity surgery , the addition of IT magnesium sulphate ( 50 mg ) to spinal anaesthesia induced by bupivacaine and fentanyl significantly delayed the onset of both sensory and motor blockade , but also prolonged the period of anaesthesia without additional side-effects .\
\
###12051573\
OBJECTIVE	Nitazoxanide ( N ) is a new broad-spectrum intestinal antiparasitic agent .\
OBJECTIVE	Deacetyl-N or tizoxanide ( T ) and its glucuronide ( TG ) are the major circulating species metabolites after oral administration of N. Bioavailability is substantially increased by food .\
OBJECTIVE	The objectives of this phase IA study were to assess the tolerability and to determine the pharmacokinetic linearity of T and TG after single oral administration of increasing doses of N with and without food in healthy volunteer subjects .\
METHODS	Thirty-two healthy male volunteers were randomly assigned to 1 of 4 treatment groups .\
METHODS	In each successive group , 2 subjects received a placebo and 6 received a single oral dose of 1 g , 2 g , 3 g , or 4 g of N , first under fasted conditions and a week later with a standardized breakfast .\
METHODS	Blood samples were collected during 24 h for plasma determination of T and TG .\
METHODS	General tolerability , adverse reactions , ECG , vital signs and laboratory tests were recorded .\
RESULTS	Tolerability was good up to the maximum dose of 4 g. Mild , mostly gastrointestinal side effects were observed and their frequency increased significantly with the dose level .\
RESULTS	No significant changes were noted in the ECGs , vital signs and laboratory tests .\
RESULTS	Plasma concentrations increased linearly with the dose from 1 - 4 g , although a trend to increased bioavailability was observed at 4 g. Food approximately doubled the concentrations of T and TG irrespective of dose .\
RESULTS	Peak times and apparent half-lives increased in proportion to the dose .\
RESULTS	The apparent body clearance for total T ( T+TG ) at the highest dose was only half that at the low dose .\
RESULTS	TG was eliminated more slowly than T.\
CONCLUSIONS	Nitazoxanide can be safely administered up to 4 g single oral doses , with or without food .\
CONCLUSIONS	The slow elimination of TG and the overproportional concentrations at the highest dose can be accounted for by solubility - or transport-limited elimination mechanisms becoming apparent at the upper dose level .\
\
###24286456\
BACKGROUND	Several chemokines , notably eotaxin , mediate the recruitment of eosinophils into tissues via the CCR3 receptor .\
OBJECTIVE	In this study , we investigated the role of CCR3 agonists in asthma by observing the effect of a small molecule antagonist of the CCR3 receptor ( GW766994 ) on sputum eosinophil counts in patients with eosinophilic asthma .\
METHODS	Clinical and physiological outcomes , the chemotactic activity of sputum supernatant for eosinophils and the presence of eosinophil progenitors in sputum and blood samples were also studied .\
RESULTS	In a double-blind parallel group study , 60 patients with asthma were randomized to 300 mg of GW766994 twice daily or matching placebo for 10 days followed by prednisone 30 mg for 5 days .\
RESULTS	Of these patients , 53 had a sputum eosinophil count > 4.9 % at baseline .\
RESULTS	Despite plasma concentrations of drug consistent with > 90 % receptor occupancy during the dosing period , the CCR3 antagonist did not significantly reduce eosinophils or eosinophil progenitor cells ( CD34 ( + ) 45 ( + ) IL-5R ( + ) ) in sputum or in blood .\
RESULTS	The ex vivo chemotactic effect of sputum supernatants on eosinophils was attenuated by GW766944 compared to placebo .\
RESULTS	There was no improvement in FEV1 ; however , there was a modest but statistically significant improvement in PC20 methacholine ( 0.66 doubling dose ) and ACQ scores , ( 0.43 ) .\
RESULTS	Whilst the improvement in PC20 is statistically significant , it is not of clinical significance .\
CONCLUSIONS	In conclusion , this study calls into question the role of CCR3 in airway eosinophilia in asthma and suggests that other cellular mechanisms mediated by the CCR3 receptor may contribute to airway hyperresponsiveness .\
\
###25098075\
BACKGROUND	Movie-based simulation training may be useful in delivering the preclinical observed OSPE curriculum , minimising the need of subjects/patients : however , a double-control trial needs to be performed and optimal timing and duration of training is yet to be defined .\
BACKGROUND	Likewise , gender-based response and students ' feedback has to be assessed .\
BACKGROUND	The objective of this study was to compare the movie-based and traditional verbal demonstration teaching methodologies .\
METHODS	Second-year medical undergraduates ( n = 90 ) of Avicenna Medical College were randomised to movie-based simulation training ( group B , n = 30 ) , traditional verbal training alone ( group C , n = 30 ) , and a combination ( group A , n = 30 ) .\
METHODS	The scores were marked by observers using a standardised key and were compared for performance at 2 observed OSPE stations .\
RESULTS	Group B and A performed significantly better than group C on station 1 and 2 .\
RESULTS	Gender factor did not seem to influence the score .\
RESULTS	A total of 99 % students reported that combination of the 2 teaching modes is the best option .\
RESULTS	They believed it offers more clear understanding with interest ( 61 % ) , long term memory ( 21 % ) , use of both senses ; seeing & hearing ( 10 % ) & better focus of attention ( 3 % ) .\
CONCLUSIONS	Even half an hour of movie-based simulation training with traditional instructor-based training may improve student performance significantly , and the students prefer a combination of the both .\
\
###25194452\
OBJECTIVE	To investigate the effect of cryotherapy after elbow arthrolysis on elbow pain , blood loss , analgesic consumption , range of motion , and long-term elbow function .\
METHODS	Prospective , single-blinded , randomized controlled study .\
METHODS	University hospital .\
METHODS	Patients ( N = 59 ; 27 women , 32 men ) who received elbow arthrolysis .\
METHODS	Patients were randomly assigned into a cryotherapy group ( n = 31 , cryotherapy plus standard care ) or a control group ( n = 28 , standard care ) .\
METHODS	Elbow pain at rest and in motion were measured using a visual analog scale ( VAS ) on postoperative day ( POD ) 1 to POD 7 and at 2 weeks and 3 months after surgery .\
METHODS	Blood loss and analgesic consumption were recorded postoperatively .\
METHODS	Elbow range of motion ( ROM ) was measured before surgery and on POD 1 , POD 7 , and 3 months after surgery .\
METHODS	The Mayo Elbow Performance Score ( MEPS ) was evaluated preoperatively and 3 months postoperatively .\
RESULTS	VAS scores were significantly lower in the cryotherapy group during the first 7 PODs , both at rest and in motion ( P < .05 ) .\
RESULTS	There were no significant differences between the 2 groups in VAS scores at 2 weeks and 3 months after surgery .\
RESULTS	Less sufentanil was consumed by the cryotherapy group than the control group for pain relief ( P < .01 ) .\
RESULTS	No significant differences were found in blood loss , ROM , and MEPS between the 2 groups ( P > .05 ) .\
CONCLUSIONS	Cryotherapy is effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis .\
CONCLUSIONS	The application of cryotherapy will not affect blood loss , ROM , or elbow function .\
\
###24195209\
OBJECTIVE	To explore a better therapy for knee osteoarthritis .\
METHODS	One hundred cases were randomly divided into a comprehensive group and an acupuncture group , 50 cases in each one .\
METHODS	The comprehensive treatment of fire needles at bones combined with cupping and Tuina on local area of affected knee was applied in the comprehensive group .\
METHODS	The Ashi points were mainly selected in the fire needles at bones therapy , once every other day .\
METHODS	The cupping and Tuina therapy was adopted once a day .\
METHODS	The conventional acupuncture was applied in the acupuncture group , in which Dubi ( ST 35 ) , Neixiyan ( EX-LE 4 ) , Xuehai ( SP 10 ) , Liangqiu ( ST 34 ) and so on were selected , once a day .\
METHODS	Ten days of treatment were taken as a treatment course in both two groups , and totally 1 to 2 courses was required .\
METHODS	The pain score of joint before and after the treatment was observed and efficacy was assessed in two groups .\
RESULTS	Compared before the treatment , the pain score of joint after the treatment was obviously improved in two groups ( both P < 0.05 ) , and the score in the comprehensive group was lower than that in the acupuncture group ( P < 0.05 ) .\
RESULTS	The clinical cured rate was 38.0 % ( 19/50 ) , which was superior to 20.0 % ( 10/50 ) in the acupuncture group .\
CONCLUSIONS	The comprehensive treatment of fire needles at bones combined with cupping and Tuina , considered as a better therapy for knee osteoarthritis , could improve joint pain , swelling and action function , which is superior to the conventional acupuncture .\
\
###21073098\
OBJECTIVE	This pilot study compared the effectiveness of 3 postoperative rehabilitation protocols for patients with Zones V and VI extensor tendon lacerations .\
METHODS	Twenty-seven patients were recruited from 3 sites and randomly assigned to 1 of 3 established treatment protocols : immobilization , early passive motion ( EPM ) , and early active motion ( EAM ) .\
METHODS	Outcome measures were collected at 3 , 6 , and 12 wk after treatment and included total active motion ( TAM ) .\
RESULTS	At the end of Week 12 , data on 24 injured digits of 18 patients were available for analysis .\
RESULTS	When data at Weeks 3 , 6 , and 12 were compared , patients in all groups showed steady improvement in TAM , but digits under the EAM treatment improved to a greater extent over time ( F [ 2 , 46 ] = 75.6 , p < .001 ) .\
CONCLUSIONS	Patients with Zones V and VI extensor tendon injuries treated with the EAM protocol recovered range of motion more rapidly .\
\
###12093340\
OBJECTIVE	Promogran , a wound dressing consisting of collagen and oxidized regenerated cellulose , is more effective that standard care in treating chronic diabetic plantar ulcers .\
METHODS	Randomized , prospective , controlled multicenter trial .\
METHODS	University teaching hospitals and primary care centers .\
METHODS	A total of 276 patients from 11 centers were enrolled in the study .\
METHODS	The mean age of the patients was 58.3 years ( range , 23-85 years ) .\
METHODS	All patients had at least 1 diabetic foot ulcer .\
METHODS	Patients were randomized to receive Promogran ( n = 138 ) or moistened gauze ( control group ; n = 138 ) and a secondary dressing .\
METHODS	Dressings were changed when clinically required .\
METHODS	The maximum follow-up for each patient was 12 weeks .\
METHODS	Complete healing of the study ulcer ( wound ) .\
RESULTS	After 12 weeks of treatment , 51 ( 37.0 % ) Promogran-treated patients had complete wound closure compared with 39 ( 28.3 % ) control patientss , but this difference was not statistically significant ( P = .12 ) .\
RESULTS	The difference in healing between treatment groups achieved borderline significance in the subgroup of patients with wounds of less than 6 months ' duration .\
RESULTS	In patients with ulcers of less than 6 months ' duration , 43 ( 45 % ) of 95 Promogran-treated patients healed compared with 29 ( 33 % ) of 89 controls ( P = .056 ) .\
RESULTS	In the group with wounds of at least 6 months ' duration , similar numbers of patients healed in the control ( 10/49 [ 20 % ] ) and the Promogran ( 8/43 [ 19 % ] ; P = .83 ) groups .\
RESULTS	No differences were seen in the safety measurements between groups .\
RESULTS	Patients and investigators expressed a strong preference for Promogran compared with moistened gauze .\
CONCLUSIONS	Promogran was comparable to moistened gauze in promoting wound healing in diabetic foot ulcers .\
CONCLUSIONS	It showed an additional efficacy for ulcers of less than 6 months ' duration that was of marginal statistical significance .\
CONCLUSIONS	Furthermore , Promogran had a safety profile that was similar to that of moistened gauze , with greater user satisfaction .\
CONCLUSIONS	Therefore , Promogran may be a useful adjunct in the management of diabetic foot ulceration , especially in ulcers of less than 6 months ' duration .\
\
###19155234\
OBJECTIVE	To compare the efficacy of Disease Activity Score ( DAS ) - driven therapy and routine care in patients with recent-onset rheumatoid arthritis .\
METHODS	Patients with recent-onset rheumatoid arthritis receiving traditional antirheumatic therapy from either the BeSt study , a randomised controlled trial comparing different treatment strategies ( group A ) , or two Early Arthritis Clinics ( group B ) were included .\
METHODS	In group A , systematic DAS-driven treatment adjustments aimed to achieve low disease activity ( DAS < or = 2.4 ) .\
METHODS	In group B , treatment was left to the discretion of the treating doctor .\
METHODS	Functional ability ( Health Assessment Questionnaire ( HAQ ) ) , Disease Activity Score in 28 joints ( DAS28 ) and Sharp/van der Heijde radiographic score ( SHS ) were evaluated .\
RESULTS	At baseline , patients in group A ( n = 234 ) and group B ( n = 201 ) had comparable demographic characteristics and a mean HAQ of 1.4 .\
RESULTS	Group A had a longer median disease duration than group B ( 0.5 vs 0.4 years , p = 0.016 ) , a higher mean DAS28 ( 6.1 vs 5.7 , p < 0.001 ) , more rheumatoid factor-positive patients ( 66 % vs 42 % , p < 0.001 ) and more patients with erosions ( 71 % vs 53 % , p < 0.001 ) .\
RESULTS	After 1 year , the HAQ improvement was 0.7 vs 0.5 ( p = 0.029 ) , and the percentage in remission ( DAS28 < 2.6 ) 31 % vs 18 % ( p < 0.005 ) in groups A and B , respectively .\
RESULTS	In group A , the median SHS progression was 2.0 ( expected progression 7.0 ) , in group B , the SHS progression was 1.0 ( expected progression 4.4 ) .\
CONCLUSIONS	In patients with recent-onset rheumatoid arthritis receiving traditional treatment , systematic DAS-driven therapy results in significantly better clinical improvement and possibly improves the suppression of joint damage progression .\
\
###25193889\
BACKGROUND	The failure of subacromial decompression may be attributed to persistent symptoms of acromioclavicular joint ( ACJ ) arthritis , while inferior clavicular spurs of the ACJ may be associated with failed healing of repaired rotator cuffs .\
OBJECTIVE	To evaluate the clinical effectiveness of arthroscopic distal clavicle resection ( DCR ) in patients with rotator cuff tears and concomitant asymptomatic radiological ACJ arthritis .\
METHODS	Randomized controlled trial ; Level of evidence , 1 .\
METHODS	A total of 78 patients with rotator cuff tears in addition to radiological and asymptomatic ACJ arthritis who were scheduled for arthroscopic rotator cuff repair were prospectively randomized into 2 groups .\
METHODS	Patients underwent arthroscopic rotator cuff repair with acromioplasty .\
METHODS	Patients in group 1 ( 39 patients ) underwent additional arthroscopic DCR , while patients in group 2 ( 39 patients ) did not .\
METHODS	Clinical outcomes of the 2 groups were compared using the visual analog scale ( VAS ) for pain , range of motion , Constant score , and American Shoulder and Elbow Surgeons ( ASES ) score up to at least 24 months .\
METHODS	The structural integrity of repaired rotator cuffs was assessed using ultrasonography , computed tomography arthrography , or MRI at least 6 months after surgery .\
METHODS	To evaluate ACJ instability , weighted stress radiography of the ACJ was studied at 6 and 12 months postoperatively .\
RESULTS	Patients in both groups showed significant improvement in the VAS score and all functional scores at final follow-up ( mean , 29.2 months ; range , 24-46 months ) without significant differences between the 2 groups ( P > .05 ) .\
RESULTS	Results ( mean SD ) for preoperative group 1/group 2 and postoperative group 1/group 2 were as follows , respectively : 7.2 1.8 / 6.1 1.9 ( P = .02 ) and 0.6 1.8 / 0.6 0.9 ( P = .97 ) for the VAS score , 74.1 5.7 / 73.8 8.0 ( P = .87 ) and 96.3 5.7 / 95.7 4.6 ( P = .77 ) for the Constant score , and 47.0 10.3 / 50.8 14.1 ( P = .22 ) and 91.5 15.5 / 94.5 11.8 ( P = .55 ) for the ASES score .\
RESULTS	Failed cuff healing occurred in 9 patients ( 23 % ) in group 1 and 10 patients ( 26 % ) in group 2 , with no significant difference ( P = .95 ) .\
RESULTS	In group 1 , there were 2 patients ( 5.0 % ) with ACJ subluxation on weighted stress radiography at 6 months postoperatively .\
RESULTS	These patients complained of gross protrusion and ACJ tenderness .\
CONCLUSIONS	Preventive arthroscopic DCR in patients with rotator cuff tears and concomitant asymptomatic radiological ACJ arthritis did not result in better clinical or structural outcomes , and it did lead to symptomatic ACJ instability in some patients .\
CONCLUSIONS	Preventive arthroscopic DCR is not recommended in patients with radiological but asymptomatic ACJ arthritis .\
CONCLUSIONS	Further long-term follow-up is needed to confirm the development of symptoms in ACJ arthritis .\
\
###16129973\
BACKGROUND	Desflurane and sevoflurane have markedly different pungencies .\
BACKGROUND	The tested hypothesis was that patients breathing equivalent concentrations of desflurane or sevoflurane through a laryngeal mask airway ( LMA ) would have similar responses .\
METHODS	After institutional review board approval and informed consent were obtained , 60 patients were enrolled and given intravenous midazolam ( 14 microg/kg ) and fentanyl ( 1 microg/kg ) 5 min before induction of anesthesia .\
METHODS	The LMA was inserted at loss of consciousness after 2 mg/kg propofol .\
METHODS	When spontaneous breathing returned , a randomly assigned volatile anesthetic was started at an inspired concentration of either 1.8 % sevoflurane or 6 % desflurane at a fresh gas flow of 6 l/min in air : oxygen ( 50:50 ) .\
METHODS	After 5 min , a controlled movement of the LMA took place .\
METHODS	Three minutes later , the inspiratory anesthetic concentration was changed to either 3.6 % sevoflurane or 12 % desflurane for 3 min .\
METHODS	A blinded observer recorded movements and airway events during the start of anesthetic , LMA movement , deepening of the anesthetic , and emergence before LMA removal .\
RESULTS	There were no differences at anesthetic start and LMA movement .\
RESULTS	Desflurane titration to 12 % increased heart rate , increased mean arterial blood pressure , and initiated frequent coughing ( 53 % vs. 0 % sevoflurane ) and body movements ( 47 % vs. 0 % sevoflurane ) .\
RESULTS	During emergence , there was a twofold greater incidence of coughing and a fivefold increase in breath holding in the desflurane group .\
CONCLUSIONS	When airway responses to sevoflurane and desflurane were compared in elective surgical patients breathing through an LMA , there were significantly more adverse responses with desflurane at 12 % concentrations and during emergence .\
\
###18268858\
BACKGROUND	Transilluminated powered phlebectomy ( TIPP ) is a minimal invasive method of varicose vein surgery that is often performed with spinal or general anaesthesia following the removal of the greater saphenous vein ( GSV ) .\
BACKGROUND	The use of exclusively local tumescent anaesthesia ( TA ) during TIPP has never been reported in the literature .\
OBJECTIVE	To introduce and evaluate the use of TIPP under TA in the treatment of tributary varicose veins .\
METHODS	Twenty patients with tributary varicose veins were treated with TIPP using the TriVex System .\
METHODS	According to duplex scanning , patients had a competent or previous ligated saphenofemoral junction .\
METHODS	All patients were clinically classified atleast as C2 according to the clinical , aetiological anatomical , pathological elements ( CEAP ) classification .\
METHODS	The postoperative follow-up was at one week , one month and three months .\
RESULTS	The mean operative time was 40.5 ( + / - 10.8 ) min , associated with an average number of 3.6 ( + / - 0.7 ) incisions .\
RESULTS	The mean pain score ( 10-point visual analog scale ) during the procedure , at one and three months after treatment were 2.0 ( + / - 1.1 ) , 1.6 ( + / - 0.9 ) and 1.2 ( + / - 0.5 ) , respectively .\
RESULTS	Thigh haematoma and complications such as discolouration , indurations and paraesthesia were reported .\
RESULTS	Fifteen ( 75 % ) patients were satisfied with the cosmetic result ( based on a 4-point visual analog scale ) after three months and 13 ( 65 % ) patients were satisfied with the performed treatment .\
RESULTS	The mean venous clinical severity ( VCS ) scores among the patients before treatment , one week , four weeks and three months after treatment was 2.7 ( + / - 1.5 ) , 3.9 ( + / - 1.6 ) , 2.4 ( + / - 2.0 ) and 1.7 ( + / - 1.9 ) , respectively .\
CONCLUSIONS	The use of TA resulted in adequate anaesthesia during TIPP .\
CONCLUSIONS	The pain , during and post-treatment , was minimal and acceptable for the patients .\
CONCLUSIONS	TIPP was associated with a high incidence of haematoma and reduction of the number of incisions .\
CONCLUSIONS	Patients were satisfied with the cosmetic result .\
\
###25483563\
OBJECTIVE	Gastroesophageal reflux disease ( GERD ) is a common condition associated with symptoms as heart burn , regurgitation , chest pain , and gastrointestinal discomfort .\
OBJECTIVE	PPC-5650 is a new pharmacological agent that can modulate acid-sensing ion channel activity , potentially leading to reduction in the pain signal .\
OBJECTIVE	In healthy volunteers the esophagus was sensitized with acid to mimic GERD with the aims : 1 ) to assess the efficacy of a single bolus of PPC-5650 locally applied to the esophagus using multimodal pain stimulations , and 2 ) to assess the safety profile of PPC-5650 .\
METHODS	The study was a randomized , double-blinded , placebo-controlled , crossover trial in healthy males .\
METHODS	Esophageal electrical , thermal , mechanical , and chemical stimulations were performed , pain perception was rated , and referred pain areas were drawn .\
METHODS	Sensitization was induced by intraluminal esophageal acid perfusions .\
METHODS	Adverse events were registered .\
RESULTS	Twenty-five healthy males completed the study ( mean age 23.4 2.0 years ) .\
RESULTS	About 90 min after drug administration , PPC-5650 increased the volume tolerated at moderate pain during mechanical stimulation compared to placebo ( difference 13.5 , 95 % CI : 0.58-26 .47 , p = 0.04 ) , but there was no effects on thermal - , electrical - , and chemical-induced pain ( all p > 0.05 ) .\
RESULTS	PPC-5650 did not affect referred pain areas to any stimulation ( all p > 0.05 ) .\
RESULTS	Ten participants reported adverse events during the placebo treatment period , and nine participants reported adverse events during the PPC-5650 treatment period ( p = 0.8 ) .\
CONCLUSIONS	Sensitization to mechanical stimulation of the esophagus was reduced by PPC-5650 compared to placebo .\
CONCLUSIONS	The overall safety and tolerability of PPC-5650 was acceptable .\
CONCLUSIONS	Thus , PPC-5650 may play a role in the future treatment of patients with GERD .\
\
###24408114\
OBJECTIVE	Increased left ventricular mass ( LVM ) , low ventricular ejection fraction ( EF ) , and high pulse-wave velocity ( PWV ) relate to overall and cardiovascular mortality in patients with ESRD .\
OBJECTIVE	The aim of this study was to determine the effect of online hemodiafiltration ( HDF ) versus low-flux hemodialysis ( HD ) on LVM , EF , and PWV .\
METHODS	Echocardiography was used to assess LVM and EF in 342 patients in the CONvective TRAnsport STudy followed for up to 4 years .\
METHODS	PWV was measured in 189 patients for up to 3 years .\
METHODS	Effect of HDF versus HD on LVM , EF , and PWV was evaluated using linear mixed models .\
RESULTS	Patients had a mean age of 63 years , and 61 % were male .\
RESULTS	At baseline , median LVM was 227 g ( interquartile range [ IQR ] , 183-279 g ) , and median EF was 65 % ( IQR , 55 % -72 % ) .\
RESULTS	Median PWV was 9.8 m/s ( IQR , 7.5-12 .0 m/s ) .\
RESULTS	There was no significant difference between the HDF and HD treatment groups in rate of change in LVM ( HDF : change , -0.9 g/yr [ 95 % confidence interval ( 95 % CI ) , -8.9 to 7.7 g ] ; HD : change , 12.5 g/yr [ 95 % CI , -3.0 to 27.5 g ] ; P for difference = 0.13 ) , EF ( HDF : change , -0.3 % / yr [ 95 % CI , -2.3 % to 1.8 % ] ; HD : change , -3.4 % / yr [ 95 % CI , -5.9 % to -0.9 % ] ; P = 0.17 ) , or PWV ( HDF : change , -0.0 m/s per year [ 95 % CI , -0.4 to 0.4 m/s ) ; HD : change , 0.0 m/s per year [ 95 % CI , -0.3 to 0.2 m/s ] ; P = 0.89 ) .\
RESULTS	No differences in rate of change between treatment groups were observed for subgroups of age , sex , residual kidney function , dialysis vintage , history of cardiovascular disease , diabetes , or convection volume .\
CONCLUSIONS	Treatment with online HDF did not affect changes in LVM , EF , or PWV over time compared with HD .\
\
###15283740\
OBJECTIVE	The development of the Antidepressant Compliance Questionnaire ( ADCQ ) , assessing patients ' attitudes and beliefs on depression and antidepressants .\
METHODS	A 51-item questionnaire was applied to 85 psychiatric out-patients with a DSM-IV diagnosis of major depressive disorder ( MDD ) .\
METHODS	This data set was used to assess psychometric properties of the ADCQ .\
METHODS	The questionnaire was also applied to 272 primary care out-patients with MDD .\
RESULTS	A principal component analysis revealed four dimensions with good internal consistency and acceptable test-retest reliability : ` perceived doctor-patient relationship ' , ` preserved autonomy ' , ` positive beliefs on antidepressants ' and ` partner agreement ' , resulting in a final questionnaire comprising 33-items .\
RESULTS	Responses were independent from depression severity and patient age .\
RESULTS	The response patterns of both psychiatric and primary care patients are provided and illustrate the many erroneous beliefs on antidepressants .\
CONCLUSIONS	The ADCQ has good psychometric properties ; further investigation should investigate whether this questionnaire is predictive of patient compliance .\
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###19381692\
OBJECTIVE	The purpose of this study was to examine patterns of circadian activity rhythms and their relationship with fatigue , anxiety/depression , and demographic/medical variables in women receiving breast cancer adjuvant therapy treatments ( Tx ) at three times within a randomized clinical trial ( RCT ) designed to improve sleep and modify fatigue .\
METHODS	A RCT enrolled 219 women with stage I-IIIA breast cancer who were randomized 2 days prior to starting chemotherapy to a behavioral therapy sleep intervention or healthy eating control group .\
METHODS	All cases with available data ( n = 190 ) were included in a descriptive , correlational , repeated measures analysis .\
METHODS	Activity data were collected continuously by wrist actigraphy for 7 days at three times : the start ( Tx 1 ) , continuation ( Tx 3 ) , and recovery ( 30 days after last Tx ) of chemotherapy .\
METHODS	Circadian activity rhythm parameters were generated using Action4 software ( Ambulatory Monitoring , Inc. ) .\
METHODS	Measures collected simultaneously included Piper Fatigue Scale , Hospital Anxiety and Depression Scale , and demographic/medical variables .\
RESULTS	Circadian activity rhythm parameters at three times in both groups were disrupted compared to healthy adults , but similar to values of cancer patients .\
RESULTS	Significant changes in mesor , amplitude , peak activity , and 24 h autocorrelation values were found over time in both groups .\
RESULTS	The intervention group 's amplitude and circadian quotient values were significantly more robust .\
RESULTS	More robust activity rhythms were associated with lower fatigue , depressive symptoms , body mass index , and higher performance status in both groups .\
CONCLUSIONS	Disrupted patterns of circadian activity rhythms were prevalent and associated with distressing fatigue and depressive symptoms during chemotherapy and at recovery .\
CONCLUSIONS	The intervention resulted in more robust rhythms .\
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###15153734\
OBJECTIVE	To evaluate and compare the results of regimen A ( 3 instillations at 8-hourly intervals in 1 day ) with the control regimen B ( 9 instillations at 8-hourly intervals in 3 days ) of using 1 % silver nitrate solution for renal pelvic instillation sclerotherapy in ` clinically significant ' filarial chyluria .\
METHODS	Forty-seven patients with clinically significant chyluria attending on 2 different days our urology clinic were prospectively randomized between two groups ; the study group received regimen A ( n = 21 ) while the control group received regimen B ( n = 26 ) .\
METHODS	The variables evaluated included visualization of pyelolymphatic fistulae on retrograde pyelography , hospital stay , outcome and morbidity of the two regimens .\
RESULTS	Patients in both groups were comparable for age and sex .\
RESULTS	The morbidity ( fever , symptomatic UTI , hematuria ) following regimen A was less than that of regimen B although not statistically significant .\
RESULTS	The average hospital stay was 3 days for regimen A and 5.5 days for regimen B ( p = 0.001 ) .\
RESULTS	The initial success rate was 80.95 % in group A and 92.30 % in group B ( p = 0.47 ) .\
RESULTS	The mean duration of follow-up was 15 months ( range 9-18 ) .\
RESULTS	There was no significant difference in recurrence between the two groups during follow-up ( group A : 21.05 % and group B : 22.72 % ; p = 0.98 ) .\
CONCLUSIONS	Regimen A was as effective as regimen B. Regimen A had the advantages of having less morbidity and shorter duration of hospital stay .\
CONCLUSIONS	We recommend only a 3-instillation regimen in patients with clinically significant chyluria , particularly those who demonstrate pyelolymphatic fistulae on retrograde pyelography .\
\
###17285405\
OBJECTIVE	We wished to compare the effectiveness of intravenous-based ( IV ) and epidural-based ( EPI ) techniques for anesthesia and postoperative analgesia in elderly patients undergoing laparoscopic cholecystectomy .\
OBJECTIVE	Effectiveness was compared in terms of reduction of postoperative pain and adverse events , and achieving a high level of patient satisfaction .\
METHODS	Thirty American Society of Anesthesiologists ( ASA ) physical status I-II patients aged more than 65 years , scheduled for laparoscopic cholecystectomy , were enrolled in this study .\
METHODS	The patients in the IV group ( n = 15 ) received modified neurolept anesthesia with droperidol 0.2 mgxkg ( -1 ) and pentazocine 0.15-0 .3 mgxkg ( -1 ) ( maximum dose of 1.0 mgxkg ( -1 ) ) and 60 % nitrous oxide in oxygen , followed by postoperative intravenous infusion of 20 microgxml ( -1 ) buprenorphine , provided with a patient-controlled analgesia pump programmed to deliver a bolus of 0.5 ml with a lockout interval of 15 min and a background infusion of 0.5 mlxh ( -1 ) .\
METHODS	The patients in the EPI group ( n = 15 ) had combined epidural analgesia and general anesthesia with sevoflurane and 60 % nitrous oxide in oxygen , followed by the epidural infusion of a 0.125 % bupivacaine and 5 microg x ml ( -1 ) buprenorphine mixture by means of an on-demand analgesic system ( bolus of 2 ml , lockout interval of 60 min , and background infusion of 2 mlxh ( -1 ) ) .\
RESULTS	The quality of postoperative analgesia was similar in the two groups .\
RESULTS	The incidences of intraoperative hypotension and bradycardia and postoperative hypotension were significantly lower in the IV group than in the EPI group ( P < 0.05 ) .\
RESULTS	A significantly higher level of patient satisfaction was found in the IV group compared with that in the EPI group ( P < 0.05 ) .\
RESULTS	The major contributor to dissatisfaction in the EPI group was anxiety or discomfort associated with the epidural procedures .\
CONCLUSIONS	Modified neurolept anesthesia with pentazocine and postoperative i.v. analgesia with buprenorphine were superior to epidural-based techniques , in terms of hemodynamic stability and patient satisfaction , in elderly patients undergoing laparoscopic cholecystectomy .\
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###12502975\
BACKGROUND	The use of 100 % oxygen during induction of anesthesia may produce atelectasis .\
BACKGROUND	The authors investigated how different oxygen concentrations affect the formation of atelectasis and the fall in arterial oxygen saturation during apnea .\
METHODS	Thirty-six healthy , nonsmoking women were randomized to breathe 100 , 80 , or 60 % oxygen for 5 min during the induction of general anesthesia .\
METHODS	Ventilation was then withheld until the oxygen saturation , assessed by pulse oximetry , decreased to 90 % .\
METHODS	Atelectasis formation was studied with computed tomography .\
RESULTS	Atelectasis in a transverse scan near the diaphragm after induction of anesthesia and apnea was 9.8 + / - 5.2 cm2 ( 5.6 + / - 3.4 % of the total lung area ; mean + / - SD ) , 1.3 + / - 1.2 cm2 ( 0.6 + / - 0.7 % ) , and 0.3 + / - 0.3 cm2 ( 0.2 + / - 0.2 % ) in the groups breathing 100 , 80 , and 60 % oxygen , respectively ( P < 0.01 ) .\
RESULTS	The corresponding times to reach 90 % oxygen saturation were 411 + / - 84 , 303 + / - 59 , and 213 + / - 69 s , respectively ( P < 0.01 ) .\
CONCLUSIONS	During routine induction of general anesthesia , 80 % oxygen for oxygenation caused minimal atelectasis , but the time margin before unacceptable desaturation occurred was significantly shortened compared with 100 % oxygen .\
\
###22510538\
OBJECTIVE	The aim of this study was to evaluate the opioid response in patients receiving morphine and pregabalin , independently from the presumed pain mechanisms , in comparison with patients receiving morphine treatment only .\
METHODS	A multicenter prospective randomized controlled study was carried out in a sample of 70 advanced cancer patients with pain requiring strong opioids .\
METHODS	Thirty-five patients ( group MO ) were randomized to receive sustained-release morphine using initial doses of 60 mg/day .\
METHODS	Thirty-five patients ( group MO-PR ) were randomized to start the same morphine doses and pregabalin in increasing doses , starting with 25 mg/day up to 150 mg/day in one week .\
METHODS	The following data were also recorded before starting the treatments ( T0 ) and then at week intervals for four weeks ( W1-4 ) : age , gender , primary cancer and known metastases , pain causes and mechanisms , symptoms associated with opioid therapy , pain intensity , Brief Pain Inventory ( BPI ) , morphine doses and escalation indexes ( OEIs ) , and quality of life .\
RESULTS	Forty-eight patients completed the study , twenty-eight and sixteen patients in group MO and MO-PR , respectively .\
RESULTS	Twenty patients were females , the mean age was 65.5 ( 10.3 ) , and the mean Karnofsky status was 66.0 ( 18.9 ) .\
RESULTS	No differences between groups were found in age ( P = 0.839 ) , Karnofsky status ( P = 0.741 ) , opioid doses as well as escalation indexes ( OEI mg , P = 0.260 , and OEI % , P = 0.270 ) .\
RESULTS	No differences between the two groups were found in quality of life and all BPI items .\
CONCLUSIONS	The use of low doses of pregabalin added to morphine therapy in advanced cancer patients does not seem to provide advantageous analgesic effects , despite limitations of the present study due to the number of drop-outs .\
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###25543425\
OBJECTIVE	To explore the efficacy and feasibility of dog days moxibustion plaster therapy in treatment of allergic rhinitis of different patterns/syndromes .\
METHODS	Allergic rhinitis of lung deficiency and invasion of cold , spleen qi deficiency and kidney yang deficiency , 56 patients for each pattern/syndrome were randomized into a plaster therapy group and a nasal spray group , 28 cases in each one .\
METHODS	In the plaster therapy group , according to the pattern/syndrome differentiation , with literature retrieval method , 3 acupoints of high frequency utility in clinic were selected as one group in acupoint plaster therapy .\
METHODS	For lung deficiency and invasion of cold pattern/syndrome , Feishu ( BL 13 ) , Fengmen ( BL 12 ) and Hegu ( LI 4 ) were selected .\
METHODS	For spleen qi deficiency pattern/syndrome , Pishu ( BL 21 ) , Zusanli ( ST 36 ) and Dazhui ( GV 14 ) were selected .\
METHODS	For kidney yang deficiency pattern / syndrome , Shenshu ( BL 23 ) , Dingchuan ( EX-B 1 ) and Bailao ( EX-HN 15 ) were selected .\
METHODS	Separately , on July 13 , 2013 , July 23 , 2013 , August 2 , 2013 and August 12 , 2013 , the aucpoint plaster therapy was applied , 2 to 4 h ( 1 to 2 h for children ) each time .\
METHODS	In the nasal spray group , beclometasone dipropionate aqueous nasal spray , 2 presses one nostril each time , 2 to 3 times a day , continuously for 4 weeks .\
METHODS	The symptom score and efficacy were compared before and after treatment in the patients of the two groups .\
RESULTS	The symptom scores of 3 patterns/syndromes were all apparently improved after treatment as compared with those before treatment in the patients of the two groups ( all P < 0.05 ) , and the result in the plaster therapy group was better than that of the nasal spray group ( P < 0.05 , P < 0.01 ) .\
RESULTS	For lung deficiency and invasion of cold pattern/syndrome , the total effective rate was 87.3 % ( 20/24 ) in the plaster therapy group , better than 84.6 % ( 22/26 ) in the nasal spray group ( P < 0.05 ) .\
RESULTS	For spleen qi deficiency pattern/syndrome , the total effective rate was 83.3 % ( 20/24 ) in the plaster therapy group , obviously better than 76.9 % ( 22/26 ) in the nasal spray group ( P < 0.05 ) .\
RESULTS	For kidney yang deficiency pattern/syndrome , the total effective rate was 79.2 % ( 19/24 ) in the plaster therapy group , better than 76.9 % ( 22/26 ) in the nasal spray group ( P < 0.05 ) .\
CONCLUSIONS	The dog days moxibustion plaster therapy achieves definite efficacy on allergic rhinitis at the acupoints selected based on the differentiation of different patterns/syndromes and the efficacy is better than beclometasone dipropionate aqueous nasal spray .\
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###10743698\
OBJECTIVE	Relaxation of cavernous smooth muscle is a parasympathetic and non-adrenergic , non-cholinergic mediated process which requires nitric oxide ( NO ) .\
OBJECTIVE	NO is synthesized from L-arginine by NO synthase ( NOS ) .\
OBJECTIVE	Some studies report good clinical results under oral L-arginine medication in the treatment of erectile dysfunction .\
OBJECTIVE	We examined the effectiveness and safety of L-arginine in the treatment of mixed-type impotence .\
METHODS	32 patients ( mean age 51.6 years ) with mixed-type impotence diagnosed according to the results of sexual history and urological examination were enrolled in a randomized , placebo-controlled , crossover comparison of an oral placebo with 3 x 500 mg L-arginine/day .\
METHODS	A validated questionnaire ( KEED ) was used to define the grade of impotence with a score .\
METHODS	The treatment consisted of two 17-day courses ( 50 tablets ) .\
METHODS	After a 7-day washout period the patients who initially received the placebo for 17 days were switched to L-arginine and vice versa .\
METHODS	We assessed the efficacy with the validated questionnaire at the end of each drug period .\
RESULTS	30 patients ( 94 % ) completed the whole treatment schedule .\
RESULTS	Five ( 17 % ) patients reported a significant improvement in erectile function at the end of the L-arginine phase and 6 ( 20 % ) patients after the placebo period .\
RESULTS	17 ( 56 % ) patients showed little improvement with L-arginine and 13 ( 43 % ) with placebo .\
RESULTS	In 8 patients ( 27 % ) of the verum group there was either no change in the ED score or even a slight worsening .\
RESULTS	No statistical difference in the impotence scores were found .\
RESULTS	No drug-related adverse effects occurred with L-arginine treatment .\
CONCLUSIONS	Oral L-arginine 3 x 500 mg/day is not better than placebo as a first-line treatment for mixed-type impotence .\
\
###10103294\
OBJECTIVE	In this study we examined changes in attention-deficit hyperactivity disorder behaviors and motor and vocal tics during withdrawal from long-term maintenance therapy with stimulant medication .\
METHODS	Subjects were 19 children with attention-deficit hyperactivity disorder and chronic tic disorder who had received methylphenidate ( n = 17 ) or dextroamphetamine ( n = 2 ) for a minimum of 1 year .\
METHODS	Children were switched to placebo under double-blind conditions .\
METHODS	Treatment effects were assessed by using direct observations of child behavior in a simulated ( clinic-based ) classroom and behavior rating scales completed by parents and clinician .\
RESULTS	There was no change ( group data ) in the frequency or severity of motor tics or vocal tics during the placebo condition compared with maintenance dose of stimulant medication ( ie , no evidence of tic exacerbation while receiving medication or of a withdrawal reaction ) .\
RESULTS	There was no evidence of tic exacerbation in the evening as a rebound effect .\
RESULTS	Treatment with the maintenance dose was also associated with behavioral improvement in attention-deficit hyperactivity disorder behaviors , indicating continued efficacy .\
CONCLUSIONS	Abrupt withdrawal of stimulant medication in children receiving long-term maintenance therapy does not appear to result in worsening of tic frequency or severity .\
CONCLUSIONS	Nevertheless , these findings do not preclude the possibility of drug withdrawal reactions in susceptible individuals .\
\
###25301251\
BACKGROUND	There is a need to find simple cost effective weight loss interventions that can be used in primary care .\
BACKGROUND	There is evidence that self-monitoring is an effective intervention for problem drinking and self-weighing might be an effective intervention for weight loss .\
OBJECTIVE	To examine the efficacy of daily self-weighing as an intervention for weight loss .\
METHODS	A randomised controlled trial of 183 obese adults , follow-up three months .\
METHODS	The intervention group were given a set of weighing scales and instructed to weigh themselves daily and record their weight .\
METHODS	Both groups received two weight loss consultations which were known to be ineffective .\
RESULTS	92 participants were randomised to the intervention group and 91 to the control group .\
RESULTS	The intervention group lost 0.5 kg ( 95 % CI 0.3 to 1.3 kg ) more than the control group , but this was not significant .\
RESULTS	There was no evidence that self-weighing frequency was associated with more weight loss .\
CONCLUSIONS	As an intervention for weight loss , instruction to weigh daily is ineffective .\
CONCLUSIONS	Unlike other studies , there was no evidence that greater frequency of self-weighing is associated with greater weight loss .\
BACKGROUND	ISRCTN05815264 .\
\
###22910287\
BACKGROUND	We hypothesized that low dose intradermal vaccination of the trivalent influenza vaccine ( TIV ) delivered by the MicronJet600 ( NanoPass Technologies , Israel ) would be non-inferior to the full dose intramuscular and mid dose Intanza ( ) vaccination in the elderly and the chronically ill adults .\
METHODS	We performed a prospective randomized trial on elderly and chronically ill adults .\
METHODS	Subjects were randomly assigned into 4 groups .\
METHODS	Groups ID3 and ID9 received reduced dose ID TIV ( 3 g and 9 g of hemagglutinin ( HA ) per strain respectively ) delivered by MicronJet600 ( NanoPass Technologies , Israel ) .\
METHODS	Group INT9 received reduced dose ID TIV ( 9 g ) delivered by Becton Dickinson 's Soluvia device ( Intanza ( ) 9 , Sanofi-Pasteur , France ) .\
METHODS	Control group IM15 received a full dose IM TIV ( 15 g ) .\
METHODS	We measured antibody titers by hemagglutination inhibition ( HAI ) and microneutralization ( MN ) assays at baseline and day 21 .\
RESULTS	Baseline characteristics for all groups were similar ( group and sample sizes : ID3 = 63 ; ID9 = 68 ; INT9 = 65 ; and IM15 = 66 ) .\
RESULTS	At day 21 post vaccination , the GMT ratio and the seroconversion rates difference for all three strains of the ID vaccine groups were non-inferior to the IM vaccine group .\
RESULTS	The seroconversion rate , seroprotection rate , and the GMT of the H1N1 strains by HAI and MN assays were significantly higher in the ID groups compared with the full dose IM vaccine group .\
RESULTS	The seroconversion rates of the H3N2 strain by HAI assay were also significantly higher in the ID groups when compared with the full dose IM group .\
RESULTS	Direct comparison among the three ID groups showed no significant differences .\
RESULTS	No serious adverse events related to vaccination were reported .\
CONCLUSIONS	Dose-sparing ID TIV can overcome reduced immunogenicity of the H1N1 strain , and according to some measures , for the H3N2 strain .\
CONCLUSIONS	At risk subjects indicated for the TIV should be considered for intradermal immunization to compensate for reduced immunogenicity .\
\
###12893326\
OBJECTIVE	To compare the efficacy and safety of an oxybutynin transdermal delivery system ( OXY-TDS ) and oral , long-acting tolterodine ( TOL-LA ) with placebo in previously treated patients with urge or mixed urinary incontinence .\
METHODS	After withdrawal of their current antimuscarinic therapy , 361 adult patients were randomized to 12 weeks of double-blind , double-dummy treatment with twice weekly OXY-TDS 3.9 mg/day , daily TOL-LA 4 mg , or placebo .\
METHODS	Evaluations included change from baseline in patient urinary diary symptoms , incontinence-specific quality of life , and safety .\
RESULTS	OXY-TDS 3.9 mg/day and TOL-LA 4 mg/day significantly reduced the number of daily incontinence episodes ( median change -3 OXY-TDS and -3 TOL-LA versus -2 placebo ; P < 0.05 ) , increased the average void volume ( median change 24 and 29 mL versus 5.5 mL , P < 0.01 ) , and improved quality of life ( incontinence impact questionnaire [ IIQ ] total score , P < 0.05 ; Urogenital Distress Inventory Irritative Symptom subscale , P < 0.05 ) compared with placebo .\
RESULTS	The most common adverse event for OXY-TDS was localized application site pruritus ( 14 % versus 4 % placebo ) accompanied by a low incidence of systemic side effects ( eg , dry mouth 4.1 % ) .\
RESULTS	Anticholinergic adverse events occurred with greatest frequency during TOL-LA treatment ( dry mouth 7.3 % versus 1.7 % placebo , P < 0.05 ) .\
CONCLUSIONS	OXY-TDS and TOL-LA are effective and comparable treatments for patients with urge and mixed incontinence .\
CONCLUSIONS	OXY-TDS improves systemic safety with regard to anticholinergic side effects .\
CONCLUSIONS	Local skin irritation occurs in some OXY-TDS patients .\
\
###7763202\
BACKGROUND	Free radicals may play a role in the pathogenesis of amyotrophic lateral sclerosis .\
OBJECTIVE	To investigate the efficacy of the free radical scavenging agent acetylcysteine in patients with amyotrophic lateral sclerosis .\
METHODS	Randomized , double-blind , placebo-controlled clinical trial to assess the effect of treatment with acetylcysteine on survival and disease progression .\
METHODS	A university hospital referral setting .\
METHODS	One hundred ten consecutive patients who fulfilled the diagnostic criteria for amyotrophic lateral sclerosis , followed up at monthly intervals for 12 months .\
METHODS	Acetylcysteine or placebo in a dose of 50 mg/kg per day subcutaneously for 12 months .\
METHODS	Survival .\
RESULTS	After 12 months , 35 patients ( 65 % ) treated with acetylcysteine and 30 ( 54 % ) given placebo were still alive ( hazard ratio , 0.74 in the acetylcysteine group relative to the placebo group ; 95 % confidence interval , 0.41 to 1.33 ; log-rank test , P = .31 ) .\
RESULTS	Rates of disease progression , as expressed by decline in muscle strength , pulmonary function , disability , and bulbar function were similar in both groups .\
RESULTS	In the subgroup of 81 patients with limb onset of the disease , 28 patients ( 74 % ) in the acetylcysteine group and 22 ( 51 % ) in the placebo group survived 12 months ( hazard ratio , 0.50 ; 95 % confidence interval , 0.24 to 1.04 ; P = .06 ) .\
RESULTS	In the bulbar subgroup of 29 patients , seven patients ( 44 % ) receiving acetylcysteine and eight ( 62 % ) receiving placebo were alive at the end of the study ( hazard ratio , 1.66 ; 95 % confidence interval , 0.56 to 4.99 ; P = .36 ) .\
CONCLUSIONS	In this trial , treatment with the free radical scavenger acetylcysteine did not result in a major increase in 12-month survival or a reduction in disease progression in patients with amyotrophic lateral sclerosis .\
\
###18082502\
BACKGROUND	Rescue percutaneous coronary intervention ( PCI ) is efficacious after clinical failure of fibrinolytic therapy and is recommended for those with persistent ischemia , hemodynamic , or electrical instability .\
BACKGROUND	We sought to describe the frequency of fibrinolytic failure ( rescue eligibility ) as well as the patient characteristics associated with rescue eligibility , rescue referral , and PCI .\
RESULTS	Eligibility , indication , and referral for guideline-based rescue PCI were adjudicated in 221 patients enrolled in the WEST trial .\
RESULTS	WEST treated patients at earliest medical contact and used a tenectaplase/enoxaparin regimen .\
RESULTS	Ninety patients ( 41 % ) were adjudicated with acute myocardial infarction as rescue eligible of whom 68 were referred for rescue PCI .\
RESULTS	Baseline characteristics did not predict rescue eligibility or referral .\
RESULTS	Emergency angiography before PCI performed a median of 82 minutes ( interquartile range 50-99 ) after rescue referral showed TIMI flow grade 2 or 3 in 34 ( 50 % ) .\
RESULTS	Percutaneous coronary intervention was adjudicated as successful in 58 of 60 attempts .\
RESULTS	Procedures began approximately 45 minutes sooner in patients initially admitted to PCI-capable hospitals .\
RESULTS	Compared to those with clinically successful fibrinolytic therapy , rescue eligible patients demonstrated higher median peak creatine phosphokinase ( 1889 [ 1243-3746 ] vs 999 [ 440-2048 ] , P < .01 ) and 30-day median NT-proBNP levels ( 748 [ 391-1916 ] vs 431 [ 153-1016 ] , P < .01 ) .\
CONCLUSIONS	Rescue eligibility determined by guideline criteria is common after contemporary fibrinolysis and is not predicted by conventional baseline characteristics .\
CONCLUSIONS	Half of rescue-referred patients are patent at angiography : although contemporary PCI success rates are high , rescue eligibility is associated with larger infarctions .\
\
###17432674\
OBJECTIVE	To observe the effect of Danzhi Xiaoyao Powder ( DXP ) on neuro-immuno-endocrine system in patients with depression .\
METHODS	A randomized double-blinded and controlled study was conducted in 63 cases of depression .\
METHODS	They were assigned to the DXP group ( 32 cases , treated with DXP ) and the control group ( 31 cases , treated with maprotiline ) .\
METHODS	The curative effect was evaluated with Hamilton 's depressive scale ( HAMD ) before and at the end of the 2nd , 4th and 6th week of the treatment .\
METHODS	Serum levels of serotonin ( 5-HT ) , norepinephrine ( NE ) , brain derived neurotrophic factor ( BDNF ) , cortisol ( CORT ) , interleukin-6 ( IL-6 ) , and interleukin-1beta ( IL-1beta ) were detected before and at the 6th week of the treatment .\
RESULTS	After 2 weeks of treatment , the total score of HAMD decreased remarkably in both groups ( P < 0.01 ) , and the total score , as well as the scores of the three factors , i. e. anxiety/somatization , cognitive impairment and feeling of despair , were lower in the DXP group than that in the control group respectively ( P < 0.05 or P < 0.01 ) .\
RESULTS	After 4 and 6 weeks of treatment the total score and score of the three factors all reduced significantly in both groups ( P < 0.01 ) , with insignificant difference between the groups .\
RESULTS	After 6 weeks of treatment , the serum levels of 5-HT and BDNF increased ( P < 0.01 ) , and the serum IL-6 level decreased in both groups ( P < 0.05 or P < 0.01 ) , the serum CORT level reduced in the DXP group ( P < 0.01 ) , while the serum NE level elevated in the control group ( P < 0.01 ) .\
CONCLUSIONS	DXP is effective in improving symptoms of depression by regulating the levels of 5-HT , BDNF , CORT and IL-6 .\
\
###21263010\
BACKGROUND	Antidepressants exhibit a variety of pharmacological actions including inhibition of the serotonin and noradrenaline transporters .\
BACKGROUND	We wished to investigate whether genetic variation could be used to target or personalise treatment , in a comparison of selective serotonin reuptake inhibitors ( SSRIs ) with noradrenaline reuptake inhibitors ( NARIs ) .\
OBJECTIVE	To test the hypothesis that patients homozygous for the long ( insertion ) polymorphism of the serotonin transporter ( 5-HTTLPR ) have an increased response to SSRI antidepressants but not to NARI antidepressants .\
METHODS	In an individually randomised , parallel-group controlled trial , people meeting criteria for a depressive episode who were referred by their general practitioner were randomised to receive either citalopram ( an SSRI ) or reboxetine ( an NARI ) .\
METHODS	Randomisation was by means of a remote automated system accessed by telephone .\
METHODS	The main outcome was depressive symptoms , measured by Beck Depression Inventory ( BDI ) total score 6 weeks after randomisation .\
METHODS	The trial was registered with the International Standard Randomised Controlled Trials Number registry ( ISRCTN31345163 ) .\
RESULTS	Altogether 298 participants were randomised to receive citalopram and 303 were randomised to reboxetine .\
RESULTS	At 6 weeks follow-up , complete data were available for 258 participants taking citalopram and 262 taking reboxetine .\
RESULTS	We found no evidence to support an influence of 5-HTTLPR on outcome following antidepressant treatment .\
RESULTS	The interaction term for BDI score at 6 weeks was 0.50 ( 95 % CI -2.04 to 3.03 , P = 0.70 ) , which indicated that responses to the SSRI and NARI were similar irrespective of 5-HTTLPR genotype .\
CONCLUSIONS	It is unlikely that the 5-HTTLPR polymorphism alone will be clinically useful in predicting response to antidepressants in people with depression .\
\
###23016811\
OBJECTIVE	To compare the use of polymerized stroma-free bovine hemoglobin ( Hb-200 ) and 6 % hetastarch 450/0 .7 ( HES 450/0 .7 ) in 0.9 % saline during fluid resuscitation of dogs with gastric dilatation-volvulus ( GDV ) .\
METHODS	Prospective , randomized clinical case series .\
METHODS	Private specialty and referral clinic .\
METHODS	Twenty client-owned dogs presenting with GDV .\
METHODS	Dogs presenting with GDV and abnormal perfusion parameters first received rapid IV infusion of a buffered isotonic replacement crystalloid ( 15 mL/kg ) and IV opioids .\
METHODS	Patients were then randomized to receive either Hb-200 ( N = 10 ) or HES 450/0 .7 ( N = 10 ) .\
METHODS	Balanced isotonic replacement crystalloids ( 10-20 mL/kg IV ) were rapidly infused along with either Hb-200 or HES in 5 mL/kg IV aliquots to meet resuscitation end points .\
RESULTS	Resuscitation was defined as meeting at least 2 of 3 criteria : ( 1 ) capillary refill time 1-2 seconds , pink mucous membrane color , strong femoral pulse quality ; ( 2 ) heart rate ( HR ) 150/min ; or ( 3 ) indirect arterial systolic blood pressure ( SBP ) > 90 mm Hg .\
RESULTS	HR , SBP , packed cell volume , hemoglobin , glucose , venous pH , bicarbonate , base excess , anion gap , and colloid osmotic pressure were compared at hospital entry and within 30 minutes post-resuscitation .\
RESULTS	Compared to the HES group , the Hb-200 group required significantly less colloid ( 4.2 versus 18.4 mL/kg ) and crystalloid ( 31.3 versus 48.1 mL/kg ) to reach resuscitation end points ( P = 0.001 ) .\
RESULTS	Time to resuscitation was significantly shorter in the Hb-200 group ( 12.5 versus 52.5 min ) .\
CONCLUSIONS	Dogs with GDV receiving Hb-200 during initial resuscitation required smaller volumes of both crystalloid and colloid fluids and reached resuscitation end points faster than dogs receiving HES 450/0 .7 ( P = 0.02 ) .\
\
###24193291\
OBJECTIVE	Although angiogenesis plays an important role in the invasion and metastasis of solid tumors , very few anti-angiogenetic drugs have been developed .\
OBJECTIVE	Reexamining the anti-angiogenetic effects of existing drugs such as Thalidomide is another possible strategy for drug discovery .\
OBJECTIVE	Irsogladine maleate ( IM ) is a drug invented to treat gastric ulcers ; however , several reports have shown that IM also exerts anti-angiogenetic effects in vitro , in vivo and in humans .\
OBJECTIVE	In order to elucidate whether treatment with IM would improve the prognoses of patients with resected lung cancer , we conducted a randomized trial .\
METHODS	In the control group , uracil-tegafur ( 250 mg/m2/day ) was administered for two years to patients with resected stage IB - IIIA lung cancer , and no adjuvant therapy was administered to those with stage IA disease .\
METHODS	In the study group , IM ( 4 mg/body/day ) was additionally administered for two years .\
RESULTS	No significant differences were observed in the major prognostic factors among 305 eligible patients between the study and control groups .\
RESULTS	Adverse effects were minimal .\
RESULTS	The overall survival of the patients in the study and control groups were not statistically different .\
RESULTS	When the analysis was stratified by regimen , among the patients with resected stage IA disease , disease-specific survival in the study group was slightly higher than that in the control group ; however , the difference was not significant ( p = 0.07 ) .\
CONCLUSIONS	Although it could not be proven that IM improves the prognoses of resected lung cancer patients , IM might have some effect on resected stage IA disease , and another trial should be conducted .\
\
###20932189\
OBJECTIVE	The objective of this study was to compare immediate effect of acupuncture at SP6 on uterine arterial blood flow in primary dysmenorrhea with that of GB39 .\
METHODS	This was a prospective , randomized clinical trial .\
METHODS	Sixty-six ( 66 ) patients with primary dysmenorrhea from the Affiliated Hospital of Shangdong University of Traditional Chinese Medicine were recruited .\
METHODS	The SP6 group ( n = 32 ) was treated with manual acupuncture at bilateral SP6 for 5 minutes after obtaining needling sensation ( de qi ) during the period of menstrual pain , whereas the control group ( n = 34 ) was needled at GB39 of both sides for 5 minutes when they suffered menstrual pain .\
METHODS	Differences in pulsatility index ( PI ) , resistance index ( RI ) , and ratio of systolic peak and diastolic peak ( A/B ) in uterine arteries were the main outcome measures .\
RESULTS	Highly significant reductions were observed in the SP6 treatment group 5 minutes after treatment in menstrual pain scores ( 8.17 1.90 versus 11.20 2.66 ; p < 0.001 ) , values of PI ( 1.75 0.48 versus 2.32 0.70 ; p < 0.001 ) , RI ( 0.72 0.11 versus 0.78 0.07 ; p < 0.001 ) , and A/B ( 4.33 1.37 versus 5.23 1.67 ; p < 0.001 ) .\
RESULTS	Compared with the GB39 control group , patients in the SP6 treatment group showed significant reductions in 5 minutes after treatment in the changes of menstrual pain scores ( 3.03 2.36 versus 0.00 0.29 ; p < 0.001 ) , values of PI ( 0.57 0.42 versus -0.10 0.58 ; p < 0.001 ) , RI ( 0.06 0.08 versus -0.03 0.15 ; p < 0.01 ) , and A/B ( 0.90 0.87 versus 0.23 1.02 ; p < 0.01 ) .\
RESULTS	There were no significant changes in menstrual pain scores , values of PI , RI , or A/B before and after treatment in the GB39 control group ( p > 0.05 ) .\
RESULTS	No adverse events from treatment were reported .\
CONCLUSIONS	This study suggests that needling at SP6 can immediately improve uterine arterial blood flow of patients with primary dysmenorrhea , while GB39 does not have these effects .\
\
###20377585\
BACKGROUND	Data are lacking on the use of topical therapies in combination with tumour necrosis factor blockers for the treatment of psoriasis .\
OBJECTIVE	To assess the efficacy and safety of adalimumab ( ADA ) with topical calcipotriol/betamethasone ( C/B ) in patients with psoriasis resembling those treated in routine clinical practice .\
METHODS	A 16-week , randomized , vehicle-controlled trial was conducted in patients with moderate to severe psoriasis and previous failure , intolerance or contraindications to two or more systemic treatments .\
METHODS	All patients received ADA ( 80 mg , week 0 ; 40 mg every other week , weeks 1-15 ) in addition to either topical C/B or drug-free vehicle applied once daily for 4 weeks , and as needed thereafter .\
METHODS	The primary endpoint was 75 % improvement from baseline in Psoriasis Area and Severity Index ( PASI 75 ) at week 16 .\
RESULTS	A total of 730 patients received either ADA + C/B ( n = 366 ) or ADA + vehicle ( n = 364 ) .\
RESULTS	PASI 75 response was initially higher with the combination therapy [ 14.8 % for ADA + C/B vs. 5.8 % for ADA + vehicle at week 2 ( P < 0.001 ) ; and 40.7 % vs. 32.4 % , respectively , at week 4 ( P = 0.021 ) ] .\
RESULTS	After week 4 , the trend was towards a higher response with ADA monotherapy , with no statistical difference in the PASI 75 response at week 16 ( 64.8 % for ADA + C/B vs. 70.9 % for ADA monotherapy , P = 0.086 ) .\
RESULTS	Safety findings were consistent with previous ADA trials .\
CONCLUSIONS	ADA + C/B resulted in more rapid and higher efficacy within the first 4 weeks ; thereafter , the trend was towards a higher response with ADA monotherapy .\
CONCLUSIONS	There was no statistical difference in the PASI 75 response at week 16 .\
CONCLUSIONS	Both treatment regimens were well tolerated .\
\
###18519426\
OBJECTIVE	Elderly patients are at high risk from non-ST-segment elevation acute coronary syndromes ( NSTE ACS ) as well as from treatment-related complications .\
OBJECTIVE	Age-associated changes in physiology may alter the risk and benefit expected from therapy .\
OBJECTIVE	The SYNERGY database was used to study the influence of age on treatment outcomes with enoxaparin vs. unfractionated heparin ( UFH ) in patients with high-risk NSTE ACS .\
RESULTS	Age was analysed as a continuous and categorical variable ( < 65 , 65-74 , and > or = 75 years , and < 75 and > or = 75 years ) for descriptive purposes .\
RESULTS	Logistic regression was used to adjust the outcomes of 30-day death , death or myocardial infarction ( MI ) , and major bleeding for baseline characteristics .\
RESULTS	Odds ratios compared outcomes by age and by treatment within age groups .\
RESULTS	Model interaction terms were used to test for statistically different outcomes by treatment and age .\
RESULTS	Overall , 9977 randomized patients had age information , of whom 25.5 % ( 2540 ) were > or = 75 years of age .\
RESULTS	Elderly patients ( > or = 75 years ) had more cardiovascular risk factors , prior cardiac disease , and higher acuity at presentation .\
RESULTS	After adjustment , advanced age ( per 10 years ) was associated with 30-day death or MI [ risk odds ratios ( ROR ) : 1.14 , P = 0.002 ] , 30-day death ( ROR : 1.54 , P < 0.0001 ) , and 1-year death ( ROR : 1.47 , P < 0.0001 ) , as well with TIMI major bleeding ( ROR : 1.21 , P = 0.001 ) , GUSTO severe bleeding ( ROR : 1.20 , P = 0.047 ) , and transfusion ( ROR : 1.04 , P = 0.324 ) .\
RESULTS	Although there was a higher rate of GUSTO severe bleeding noted with enoxaparin in elderly patients , the overall relationships between treatment ( UFH or enoxaparin ) and outcomes did not vary significantly as a function of the patient 's age .\
CONCLUSIONS	Although higher rates of adverse events are seen in the oldest subgroup ( age > or = 75 years ) treated with enoxaparin , statistical comparisons confirm similar efficacy and safety of enoxaparin and UFH across age subgroups as was demonstrated overall in SYNERGY .\
\
###24559194\
BACKGROUND	There is a strong association between weight gain and metabolic events in patients with schizophrenia receiving many of the second-generation antipsychotic agents .\
BACKGROUND	We explored the relationship between body mass index ( BMI ) and metabolic events in patients with schizophrenia receiving long-acting injectable paliperidone palmitate ( PP ) in a long-term trial .\
METHODS	We conducted a post hoc analysis of data from a PP study that included a 33-week open-label transition ( TR ) and maintenance phase ; a variable duration , randomized , double-blind ( DB ) , placebo-controlled phase and a 52-week open-label extension ( OLE ) phase .\
METHODS	Overall , 644 patients received PP continuously from study entry through discontinuation or study completion and were grouped by baseline BMI ( kg/m2 ) : underweight ( BMI < 19 ; n = 29 , 4.5 % ) , normal-weight ( BMI 19 - < 25 ; n = 229 , 35.6 % ) , overweight ( BMI 25 - < 30 ; n = 232 , 36.0 % ) and obese ( BMI 30 ; n = 154 , 23.9 % ) .\
METHODS	Metabolic treatment-emergent adverse events ( TEAEs ) and changes in related laboratory results from TR baseline were analyzed .\
RESULTS	PP exposure was similar across BMI groups ; overall mean ( SD ) dose/month was 70.3 ( 17.17 ) mg eq .\
RESULTS	[ 109.6 ( 26.78 ) mg ] ; median duration of exposure was 204 days ( 6 to 1009 days ) .\
RESULTS	Occurrences of metabolic TEAEs overall by group were 0 % ( underweight ) , 14.9 % ( normal-weight ) , 14.7 % ( overweight ) , and 24.0 % ( obese ) .\
RESULTS	The most common ( 2 % ) metabolic TEAE were weight gain and elevated blood levels of glucose , lipids , and insulin .\
RESULTS	Mean BMI and weight increased in normal-weight and overweight groups at DB endpoint , and in underweight , normal-weight and overweight groups at OLE endpoint ( p 0.05 ) .\
RESULTS	No consistent trend for increased metabolic-related laboratory values by baseline BMI group was observed .\
RESULTS	Homeostatic model assessments for insulin resistance indicated preexisting insulin resistance at baseline , with minimal changes at OLE endpoint across baseline BMI groups .\
CONCLUSIONS	Occurrences of metabolic-related TEAEs trended with greater BMI status in patients with schizophrenia treated with PP ; consistent trends in metabolic-related laboratory values were not observed .\
BACKGROUND	This study is registered at ClinicalTrials.gov ( NCT 00518323 ) .\
\
###8078529\
BACKGROUND	Corticosteroids are the most efficacious drugs for inducing remission in active Crohn 's disease , but their benefits are frequently offset by serious side effects .\
BACKGROUND	Budesonide is a corticosteroid with high topical antiinflammatory activity but low systemic activity because of extensive hepatic metabolism .\
BACKGROUND	We investigated the efficacy and safety of an oral controlled-ileal-release preparation of budesonide in patients with active Crohn 's disease involving the ileum or ileum and proximal colon .\
METHODS	In a double-blind , multicenter trial , 258 patients were randomly assigned to receive placebo or one of three doses of budesonide -- 3 , 9 , or 15 mg daily .\
METHODS	The primary outcome measure was clinical remission , as defined by a score of 150 or less on the Crohn 's disease activity index .\
RESULTS	After eight weeks of treatment , remission occurred in 51 percent of the patients in the group receiving 9 mg of budesonide ( 95 percent confidence interval , 39 to 63 percent ) , 43 percent of those receiving 15 mg ( 95 percent confidence interval , 31 to 55 percent ) , and 33 percent of those receiving 3 mg ( 95 percent confidence interval , 21 to 44 percent ) , as compared with 20 percent of those receiving placebo ( P < 0.001 , P = 0.009 , and P = 0.13 , respectively ) .\
RESULTS	Improvements in the quality of life , as measured by the patients ' responses to the inflammatory bowel disease questionnaire , paralleled these remission rates .\
RESULTS	Location of disease , prior surgical resection , and previous use of corticosteroids did not affect the outcome .\
RESULTS	A total of 119 patients ( 46 percent ) were withdrawn from the study before the trial ended , 96 because of insufficient therapeutic effects , 13 because of adverse reactions , and 10 because of noncompliance .\
RESULTS	Budesonide caused a dose-related reduction in basal and corticotropin-stimulated plasma cortisol concentrations but was not associated with clinically important corticosteroid-related symptoms or other toxic effects .\
CONCLUSIONS	In an eight-week trial , an oral controlled-release preparation of budesonide at an optimal daily dose of 9 mg was well tolerated and effective against active Crohn 's disease of the ileum and proximal colon .\
\
###21888656\
BACKGROUND	Offspring of women with schistosomiasis may exhibit immune responsiveness to schistosomes due to in utero sensitisation or trans-placental transfer of antibodies .\
BACKGROUND	Praziquantel treatment during pregnancy boosts maternal immune responses to schistosome antigens and reduces worm burden .\
BACKGROUND	Effects of praziquantel treatment during pregnancy on responses among offspring are unknown .\
METHODS	In a trial of anthelminthic treatment during pregnancy in Uganda ( ISRCTN32849447 ; http://www.controlled-trials.com/ISRCTN32849447/elliott ) , offspring of women with Schistosoma mansoni were examined for cytokine and antibody responses to schistosome worm ( SWA ) and egg ( SEA ) antigen , in cord blood and at age one year .\
METHODS	Relationships to maternal responses and pre-treatment infection intensities were examined , and responses were compared between the offspring of women who did , or did not receive praziquantel treatment during pregnancy .\
RESULTS	Of 388 S. mansoni-infected women studied , samples were obtained at age one year from 215 of their infants .\
RESULTS	Stool examination for S. mansoni eggs was negative for all infants .\
RESULTS	Cord and infant samples were characterised by very low cytokine production in response to schistosome antigens with the exception of cord IL-10 responses , which were substantial .\
RESULTS	Cord and infant cytokine responses showed no association with maternal responses .\
RESULTS	As expected , cord blood levels of immunoglobulin ( Ig ) G to SWA and SEA were high and correlated with maternal antibodies .\
RESULTS	However , by age one year IgG levels had waned and were hardly detectable .\
RESULTS	Praziquantel treatment during pregnancy showed no effect on cytokine responses or antibodies levels to SWA or SEA either in cord blood or at age one year , except for IgG1 to SWA , which was elevated in infants of treated mothers , reflecting maternal levels .\
RESULTS	There was some evidence that maternal infection intensity was positively associated with cord blood IL-5 and IL-13 responses to SWA , and IL-5 responses to SEA , and that this association was modified by treatment with praziquantel .\
CONCLUSIONS	Despite strong effects on maternal infection intensity and maternal immune responses , praziquantel treatment of infected women during pregnancy had no effect on anti-schistosome immune responses among offspring by age one year .\
CONCLUSIONS	Whether the treatment will impact upon the offspring 's responses on exposure to primary schistosome infection remains to be elucidated .\
BACKGROUND	ISRCTN : ISRCTN32849447 .\
\
###20500867\
BACKGROUND	The standard of care for colorectal peritoneal carcinomatosis is evolving from chemotherapy to cytoreductive surgery ( CRS ) with hyperthermic intraperitoneal chemotherapy ( HIPEC ) for patients with disease limited to the peritoneum .\
BACKGROUND	Peritoneal carcinomatosis from colorectal cancer treated with chemotherapy alone results in median survival of 5 to 13 months , whereas CRS with HIPEC for early peritoneal carcinomatosis from colorectal cancer resulted in median survival of 48-63 months and 5 year survival of 51 %.Com pleteness of cytoreduction and limited disease are associated with longer survival , yet early peritoneal carcinomatosis is undetectable by conventional imaging .\
BACKGROUND	Exploratory laparotomy can successfully identify early disease , but this approach can only be justified in patients with high risk of peritoneal carcinomatosis .\
BACKGROUND	Historical data indicates that patients presenting with synchronous peritoneal carcinomatosis , ovarian metastases , perforated primary tumor , and emergency presentation with bleeding or obstructing lesions are at high risk of peritoneal carcinomatosis .\
BACKGROUND	Approximately 55 % of these patient populations will develop peritoneal carcinomatosis .\
BACKGROUND	We hypothesize that performing a mandatory second look laparotomy with CRS and HIPEC for patients who are at high risk for developing peritoneal carcinomatosis from colorectal cancer will lead to improved survival as compared to patients who receive standard of care with routine surveillance .\
METHODS	This study is a prospective randomized trial designed to answer the question whether mandatory second look surgery with CRS and HIPEC will prolong overall survival compared to the standard of care in patients who are at high risk for developing peritoneal carcinomatosis from colorectal cancer ( CRC ) .\
METHODS	Patients with CRC at high risk for developing peritoneal carcinomatosis who underwent curative surgery and subsequently received standard of care adjuvant chemotherapy will be evaluated .\
METHODS	The patients who remain without evidence of disease by imaging , physical examination , and tumor markers for 12 months after the primary operation will be randomized to mandatory second look surgery or standard-of-care surveillance .\
METHODS	At laparotomy , CRS and HIPEC will be performed with intraperitoneal oxaliplatin with concurrent systemic 5-fluorouracil and leucovorin .\
METHODS	Up to 100 patients will be enrolled to allow for 35 evaluable patients in each arm ; accrual is expected to last 5 years .\
BACKGROUND	ClinicalTrials.gov ID : NCT01095523 .\
\
###24833736\
OBJECTIVE	We investigated whether sleep deprivation ( SD ) disturbs the tear film .\
METHODS	A total of 20 healthy male subjects with no ocular disease was recruited : 10 were allocated to the SD group and 10 to the control group The 10 subjects in the SD group were deprived of sleep in an experimental setting and their outcomes were compared to those of the control group , which was not sleep-deprived .\
METHODS	Tear film and ocular surface were evaluated at 2 PM , 10 PM , and 6 AM and 2 PM the following day .\
METHODS	Tear osmolarity , Schirmer 's test , tear film break-up time ( TBUT ) , pain on a visual analog scale ( VAS ) , and IOP were measured .\
RESULTS	At 6 AM the following day , mean tear osmolarity level increased ( P = 0.004 ) , TBUT was significantly shorter ( P = 0.01 ) , and tear secretion measured by Schirmer 's test was significantly reduced in the SD group than in the control group ( P = 0.004 ) .\
RESULTS	No significant change in IOP was observed in either group .\
CONCLUSIONS	Sleep deprivation induced tear hyperosmolarity , shortened TBUT , and reduced tear secretion , all of which can trigger the development of ocular surface diseases .\
CONCLUSIONS	Therefore , SD can exacerbate signs and symptoms in patients with ocular surface diseases .\
CONCLUSIONS	( ClinicalTrials.gov number , NCT02026986 . )\
\
###12049678\
BACKGROUND	Patients with prolonged signal-averaged ECG have four times higher risk for development of atrial fibrillation ( AF ) after coronary artery bypass surgery ( CABG ) .\
BACKGROUND	Incidence of AF is reduced , but not eliminated by prophylaxis with beta-blockers .\
BACKGROUND	The limitations of prophylaxis with oral beta-blockers may be related to the delayed effect of oral therapy .\
BACKGROUND	We performed a pilot study of the efficacy of early intravenous esmolol and an oral beta-blocker regimen for prevention of postoperative AF .\
METHODS	Fifty patients referred for CABG and considered to be at high risk for postoperative AF on the basis of prolonged signal-averaged ECG P wave duration > 140 ms were randomized to receive either a 24-hour infusion of esmolol 6-18 hours after CABG , at an average dose 67 + / - 7 microg/kg/min , followed by oral beta-blockers versus oral beta-blockers only beginning on postoperative day 1 .\
RESULTS	Seven of 27 patients ( 26 % ) in the esmolol group and 6 of 23 patients ( 26 % ) in the oral beta-blocker group developed postoperative AF , P = NS .\
RESULTS	The mean time of onset of AF ( 2.7 + / - 0.5 vs 2.7 + / - 0.3 postoperative day , P = NS ) and the median duration of AF ( 10 [ 2192 ] vs 7 [ 1.16 ] hours , P = NS ) were similar between the two groups .\
RESULTS	Eleven ( 41 % ) patients treated with esmolol developed adverse events ( hypotension : 8 , bradycardia requiring temporary pacing : 2 , left ventricular failure :1 patient ) as compared to only one patient ( 4 % ) in the beta-blocker group who developed hypotension , P = 0.006 .\
CONCLUSIONS	This randomized controlled pilot study suggests that intravenous esmolol is less well tolerated and offers no advantages to standard beta-blocker in preventing AF after CABG .\
\
###14749647\
OBJECTIVE	The purpose of this study was to compare the efficacy of two protocols for active management of labor at term in the presence of an unfavorable cervix .\
METHODS	Pregnancies that underwent labor induction at > or = 37 weeks of gestation with an unfavorable cervix ( Bishop score , < or = 6 ) were randomly assigned to receive vaginally either a single dose of sustained-release dinoprostone ( Cervidil ) with concurrent low-dose oxytocin or multidosing of misoprostol ( 25 microg every 4 hours ) followed by high-dose oxytocin .\
METHODS	The primary outcome was the time interval from induction to vaginal delivery .\
METHODS	Other parameters included excess uterine activity and cesarean delivery rates .\
RESULTS	A total of 151 patients ( dinoprostone , 74 patients ; misoprostol , 77 patients ) were enrolled .\
RESULTS	The mean time from the initiation of induction to vaginal delivery was the same in the dinoprostone and misoprostol groups ( 15.7 hours ; 95 % CI , 13.7-17 .7 hours vs 16.0 hours ; 95 % CI , 14.1-17 .8 hours ; P = .34 ) , regardless of parity .\
RESULTS	The dinoprostone and misoprostol groups did not differ statistically in the percent of patients who were delivered vaginally by 12 hours ( 36.2 % vs 29.7 % ) , 18 hours ( 63.8 % vs 56.3 % ) , and 24 hours ( 81.0 % vs 81.3 % ) .\
RESULTS	Excess uterine activity was not more common in either group , and hyperstimulation syndrome was absent in all cases .\
RESULTS	Primary cesarean delivery rates were similar ( dinoprostone , 21.6 % ; misoprostol , 16.9 % ; relative risk , 1.3 ; 95 % CI , 0.7-2 .5 ) , with a failed induction that occurred in one case in each group .\
CONCLUSIONS	Sustained-release dinoprostone with concurrent low-dose oxytocin and intermittent misoprostol with delayed high-dose oxytocin are effective alternatives for active management of labor with an unfavorable cervix .\
\
###19364166\
OBJECTIVE	To determine the efficacy of 2 different sources of Ginkgo biloba extract ( GBE ) in reducing the incidence and severity of acute mountain sickness ( AMS ) following rapid ascent to high altitude .\
METHODS	Two randomized , double-blind , placebo-controlled cohort studies were conducted in which participants were treated with GBE ( 240 mg x d ( -1 ) ) or placebo prior to and including the day of ascent from 1600 m to 4300 m ( ascent in 2 hours by car ) .\
METHODS	Acute mountain sickness was diagnosed if the Environmental Symptom Questionnaire III acute mountain sickness-cerebral ( AMS-C ) score was > or = 0.7 and the Lake Louise Symptom ( LLS ) score was > or = 3 and the participant reported a headache .\
METHODS	Symptom severity was also determined by these scores .\
RESULTS	Results were conflicting : Ginkgo biloba reduced the incidence and severity of AMS compared to placebo in the first but not the second study .\
RESULTS	In the first study , GBE reduced AMS incidence ( 7/21 ) vs placebo ( 13/19 ) ( P = .027 , number needed to treat = 3 ) , and it also reduced severity ( AMS-C = 0.77 + / - 0.26 vs 1.59 + / - 0.27 , P = .029 ) .\
RESULTS	In the second study , GBE did not reduce incidence or severity of AMS ( GBE 4/15 vs placebo 10/22 , P = .247 ; AMS-C = 0.48 + / - 0.13 vs 0.58 + / - 0.11 , P = .272 ) .\
RESULTS	The primary difference between the 2 studies was the source of GBE .\
CONCLUSIONS	The source and composition of GBE products may determine the effectiveness of GBE for prophylaxis of AMS .\
\
###21378581\
BACKGROUND	Open fractures are an important source of morbidity and are associated with delayed union , nonunion , and infection .\
BACKGROUND	Preventing infection through meticulous irrigation and debridement is an important goal in management , and different lavage fluids and irrigation techniques ( e.g. , high - or low-pressure lavage ) have been described for this purpose .\
BACKGROUND	However , there are a limited number of randomized trials comparing irrigating solutions or irrigating technique .\
BACKGROUND	We compared the use of castile soap versus normal saline and high - versus low-pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds .\
METHODS	We conducted a multicenter , blinded , randomized 2 2 factorial pilot trial of 111 patients in whom an open fracture wound was treated with either castile soap solution or normal saline and either high - or low-pressure pulsatile lavage .\
METHODS	The primary composite outcome of reoperation , measured at 12 months after initial operative procedure , included infection , wound healing problems , and nonunion .\
METHODS	Planned reoperations were not included .\
METHODS	Secondary outcomes included all infection , all wound healing problems , and nonunion as well as functional outcomes scores ( EuroQol-5 dimensions and short form-12 ) .\
RESULTS	Eighty-nine patients completed the 1-year follow-up .\
RESULTS	Among all patients , 13 ( 23 % ) in the castile soap group and 13 ( 24 % ) in the saline group had a primary outcome event ( hazard ratio , 0.91 , 95 % confidence interval : 0.42-2 .00 , p = 0.52 ) .\
RESULTS	Sixteen patients ( 28 % ) in the high-pressure group and 10 patients ( 19 % ) in the low-pressure group had a primary outcome event ( hazard ratio 0.55 , 95 % confidence interval : 0.24-1 .27 , p = 0.17 ) .\
RESULTS	Functional outcome scores showed no significant differences at any time point between groups .\
CONCLUSIONS	The fluid lavage of open wounds pilot randomized controlled trial demonstrated the possibility that the use of low pressure may decrease the reoperation rate for infection , wound healing problems , or nonunion .\
CONCLUSIONS	We have demonstrated the desirability and feasibility of a definitive trial examining the effects of alternative irrigation approaches .\
\
###21170106\
OBJECTIVE	To investigate the efficacy and safety of alprostadil cream in management of female sexual arouse disorder ( FSAD ) , and its appropriate dose for clinical prescription .\
METHODS	The volunteers were assigned randomly to four groups which received alprostadil cream in different dosage ( 500 g , 700 g and 900 g ) or placebo cream , respectively .\
METHODS	The cream was applied to the clitoris and G-spot before coitus .\
METHODS	The efficacy was assessed by comparing the satisfactory rate of sexual arousal , the score of female sexual function index ( FSFI ) and female sex disorder scale ( FSDS ) and the general appraised question ( GAQ ) before and after the treatment .\
METHODS	The safety was evaluated by the adverse effects that appeared including symptoms , physical and biochemical examination .\
RESULTS	Totally , 400 women enrolled in this study with 374 assigned to the group for efficacy evaluation and 387 cases to the group for safety analysis .\
RESULTS	No significant difference was found among the four groups in the demographic characters and sexual baseline .\
RESULTS	The increase of satisfactory percentage of sexual arousal in the four groups ( placebo , 500 g , 700 g and 900 g ) was 22.63 % , 36.67 % , 34.01 % , and 44.29 % , respectively ( P < 0.05 ) , and the increase was statistically higher in the 900 g group than in the placebo group ( P < 0.0167 ) .\
RESULTS	The elevated FSFI score above the baseline in the treatment groups ( 900 g 22.89 , 700 g 21.69 , and 500 g 20.71 ) were higher than that in the placebo group ( 14.68 , P < 0.05 ) , while the reduced FSDS score below the baseline ( 900 g 25.97 , 700 g 21.98 , and 500 g 20.27 ) were higher than that of the placebo ( 17.60 , P < 0.05 ) .\
RESULTS	No significant difference was found in the four groups in GAQ ( P = 0.054 ) .\
RESULTS	The main common adverse effect was topical stimulation .\
RESULTS	No adverse effect was reported in physical and biochemical examination , electrocardiogram ( ECG ) or Thinprep cytologic test ( TCT ) .\
CONCLUSIONS	Alprostadil cream can treat female sexual arousal disorder effectively with the maximum effect at the dose of 900 g and without significant adverse effect except for mild topical stimulation .\
\
###7987528\
BACKGROUND	For current implantable defibrillators , the nonthoracotomy approach to implantation fails in a substantial number of patients .\
BACKGROUND	In a prospective randomized cross-over study the defibrillation efficacy of a standard monophasic and a new biphasic waveform was compared for different lead configurations .\
RESULTS	Intraoperatively , in 79 patients receiving nonthoracotomy defibrillation leads , the defibrillation threshold was determined in the initial lead configuration for the mono - and biphasic waveform .\
RESULTS	In each patient , both waveforms were used alternately with declining energies ( 20 , 15 , 10 , 5 J ) until failure of defibrillation occurred .\
RESULTS	Three different initial lead configurations were tested in different , consecutive , nonrandomized patients using a bipolar endocardial defibrillation lead alone ( A ; n = 36 ) or in combination with a subcutaneous defibrillation patch ( B ; n = 24 ) or array ( C ; n = 19 ) lead .\
RESULTS	The lowest successful defibrillation energy with the biphasic waveform was less than , equal to , or higher than with the monophasic waveform in 64 % , 28 % , and 8 % of patients , respectively , and on average significantly lower with the biphasic waveform for all three lead configurations ( A : 11.3 + / - 4.4 J vs 14.5 + / - 4.5 J ; B : 9.7 + / - 4.7 J vs 15.1 + / - 4.5 J ; C : 7.9 + / - 4.5 J vs 12.4 + / - 4.9 J ) .\
RESULTS	Defibrillation efficacy at 20 J was significantly improved by the biphasic waveform ( 91 % vs 76 % ) .\
CONCLUSIONS	In combination with nonthoracotomy defibrillation leads , the biphasic waveform of a new implantable cardioverter defibrillator showed superior defibrillation efficacy in comparison to the standard monophasic waveform .\
CONCLUSIONS	Defibrillation thresholds were improved for lead systems with and without a subcutaneous patch or array lead .\
\
###11783228\
OBJECTIVE	To study the effect and mechanism of Shenlian Ear-Drops ( SLED ) , a composite preparation of Chinese herbal medicine , in treating chronic pyogenic tympanitis ( CPT ) .\
METHODS	The 201 patients of CPT enrolled were divided randomly into two groups .\
METHODS	The treated group were treated with SLED , three times per day , and the control group treated with ofloxacin ear-drop , three times per day .\
METHODS	The changes in symptoms , signs and bacterial culture after treatment were observed .\
METHODS	Experimental studies on anti-inflammatory , detumescent effect and skin mucosa irritation test , and bacteriostasic activity of SLED were also conducted .\
RESULTS	The curative effect in the treated group was higher than that in the control group with shorter time of medication .\
RESULTS	The improvement of symptoms and signs in the former was also better than that in the latter ( P < 0.05 or P < 0.01 ) .\
RESULTS	Experimental study showed SLED had obvious anti-inflammatory and detumescent effect , apparent bacteriostasic activity against often encountered pathogens of CPT , and with no side-effect such as irritation on skin , mucosa of external acoustic meatus or tympanic cavity , and was non-ototoxic .\
CONCLUSIONS	SLED has good curative effect in treating CPT .\
\
###23175563\
BACKGROUND	Artemisinin-based combination therapy is very effective in clearing asexual stages of malaria and reduces gametocytemia , but may not affect mature gametocytes .\
BACKGROUND	Primaquine is the only commercially available drug that eliminates mature gametocytes .\
METHODS	We conducted a 2-arm , open-label , randomized , controlled trial to evaluate the efficacy of single-dose primaquine ( 0.75 mg/kg ) following treatment with dihydroartemisinin-piperaquine ( DHP ) on Plasmodium falciparum gametocytemia , in Indonesia .\
METHODS	Patients aged 5 years with uncomplicated falciparum malaria , normal glucose-6-phosphate dehydrogenase enzyme levels , and hemoglobin levels 8 g/dL were assigned by computerized-generating sequence to a standard 3-day course of DHP alone ( n = 178 ) or DHP combined with a single dose of primaquine on day 3 ( n = 171 ) .\
METHODS	Patients were seen on days 1 , 2 , 3 , and 7 and then weekly for 42 days to assess the presence of gametocytes and asexual parasites by microscopy .\
METHODS	Survival analysis was stratified by the presence of gametocytes on day 3 .\
RESULTS	DHP prevented development of gametocytes in 277 patients without gametocytes on day 3 .\
RESULTS	In the gametocytemic patients ( n = 72 ) , primaquine was associated with faster gametocyte clearance ( hazard ratio = 2.42 [ 95 % confidence interval , 1.39-4 .19 ] , P = .002 ) and reduced gametocyte densities ( P = .018 ) .\
RESULTS	The day 42 cure rate of asexual stages in the DHP + primaquine and DHP-only arms were : polymerase chain reaction ( PCR ) unadjusted , 98.7 % vs 99.4 % , respectively ; PCR adjusted , 100 % for both .\
RESULTS	Primaquine was well tolerated .\
CONCLUSIONS	Addition of single-dose 0.75 mg/kg primaquine shortens the infectivity period of DHP-treated patients and should be considered in low-transmission regions that aim to control and ultimately eliminate falciparum malaria .\
CONCLUSIONS	Clinical Trials Registration .\
CONCLUSIONS	NCT01392014 .\
\
###16213029\
BACKGROUND	The association between early childhood abuse and the course of illness , including psychiatric comorbidities , in adults with bipolar disorder has not been examined in a predominantly male or veteran population .\
METHODS	As part of the VA Cooperative Study 430 , `` Reducing the Efficacy-Effectiveness Gap in Bipolar Disorder , '' 330 veterans ( 91 % male ) with bipolar I or II disorder who were enrolled in a 3-year prospective study were examined for baseline data obtained at study entry .\
METHODS	Diagnoses were determined by the use of the SCID .\
METHODS	A semistructured interview designed to elicit data about exposure to childhood physical , sexual , or combined abuse was conducted as part of baseline demographic and clinical information .\
METHODS	Other reports from this data set have not addressed the issues of childhood adversity .\
RESULTS	Childhood abuse was reported by 48.3 % of the subjects ( 47.3 % of men ) .\
RESULTS	Any abuse ( AA ) was reported by 48.3 % ; sexual abuse without physical abuse ( SA ) was reported by 8 % , physical abuse without sexual abuse ( PA ) by 20.7 % , and both types of abuse ( combined abuse , CA ) by 18.7 % of the male subjects .\
RESULTS	Female veterans reported more SA ( 27 % ) and less PA ( 6.7 % ) .\
RESULTS	AA subjects were more likely to have current PTSD and lifetime diagnoses of panic disorder and alcohol use disorders .\
RESULTS	CA was associated with lower SF-36 Mental scores , higher likelihood of current PTSD and lifetime diagnoses of alcohol use disorders , as well as more lifetime episodes of major depression and higher likelihood of at least one suicide attempt .\
RESULTS	Younger age at study entry was associated with AA and PA. .\
CONCLUSIONS	Potential limitations include generalizability beyond the male , veteran population of patients with bipolar disorder and the methodology used to elicit abuse histories .\
CONCLUSIONS	Similar to studies of predominantly female nonveteran samples , this study extends the finding that a history of childhood abuse acts as a disease course modifier in male veterans with bipolar disorder .\
CONCLUSIONS	Clinicians should routinely seek information regarding abuse and be aware that these patients may be more difficult to treat than bipolar patients who have no abuse histories .\
\
###7484574\
OBJECTIVE	The purpose of this study was to evaluate the sensitivity and specificity of globular enhancement for differentiating hepatic hemangiomas from hypervascular metastases on single-pass , contrast-enhanced CT scans .\
OBJECTIVE	Globular enhancement was defined as enhancing nodules less than 1 cm seen within a lesion .\
METHODS	Fifty CT examinations were retrospectively evaluated in a blinded fashion by two independent reviewers .\
METHODS	The CT studies were done with nonhelical technique after the IV injection of 150 ml of contrast material .\
METHODS	The series included 25 patients with histologically proven hypervascular hepatic metastases ( carcinoid , islet cell carcinoma , and leiomyosarcoma ) and 25 patients with clinically proven hepatic hemangiomas .\
METHODS	Patients with hemangiomas were clinically stable for at least 2 years after the CT studies .\
METHODS	A single lesion was isolated from the first-pass , contrast-enhanced portion of each examination ; the remainder of the examination was excluded from the review to minimize reviewer bias .\
METHODS	Each lesion was evaluated for ( 1 ) the presence or absence of globular enhancement ( defined as enhancing nodules less than 1 cm seen within a lesion ) , ( 2 ) the density of globular enhancement relative to that of the aorta , ( 3 ) the degree of border definition ( well or poorly marginated ) , and ( 4 ) the presence or absence of a hypodense halo .\
METHODS	A diagnostic impression was then recorded for each lesion .\
RESULTS	Globular enhancement was 88 % sensitive and 84-100 % specific for differentiating hepatic hemangiomas from hypervascular metastases ( p < .001 ) .\
RESULTS	A mean of 62 % of hemangiomas showed globular enhancement isodense relative to that of the aorta ; none of the metastases showed globular , isodense enhancement .\
RESULTS	The majority of the metastases showed nonglobular enhancement ( mean , 92 % ) .\
RESULTS	The reviewers showed 84 % agreement in the identification of ( 1 ) globular enhancement in hemangiomas , ( 2 ) lack of globular enhancement in metastases , and ( 3 ) globular enhancement in the combined set of all lesions .\
RESULTS	Neither the presence of a hypodense halo nor the degree of border definition was significant in distinguishing between the two groups of lesions .\
RESULTS	The reviewers showed 96 % agreement in the categorization of metastases and 76 % agreement in the categorization of hemangiomas .\
RESULTS	There was 86 % agreement in the categorization of all lesions .\
RESULTS	Overall , reviewers diagnosed a mean of 89 % of lesions correctly .\
RESULTS	A mean of 98 % of metastases and a mean of 80 % of hemangiomas were diagnosed correctly .\
CONCLUSIONS	Globular enhancement is highly sensitive ( 88 % ) and specific ( 84-100 % ) for differentiating hepatic hemangiomas from hypervascular metastases on single-pass , contrast-enhanced CT scans .\
\
###23227811\
BACKGROUND	The green alga Chlorella contains high levels of proteins , vitamins , and minerals .\
BACKGROUND	We previously reported that a chlorella-derived multicomponent supplement increased the secretion rate of salivary secretory immunoglobulin A ( SIgA ) in humans .\
BACKGROUND	Here , we investigated whether intake of this chlorella-derived supplement attenuated the reduced salivary SIgA secretion rate during a kendo training camp .\
METHODS	Ten female kendo athletes participated in inter-university 6-day spring and 4-day summer camps .\
METHODS	They were randomized into two groups ; one took placebo tablets during the spring camp and chlorella tablets during the summer camp , while the other took chlorella tablets during the spring camp and placebo tablets during the summer camp .\
METHODS	Subjects took these tablets starting 4 weeks before the camp until post-camp saliva sampling .\
METHODS	Salivary SIgA concentrations were measured by ELISA .\
RESULTS	All subjects participated in nearly all training programs , and body-mass changes and subjective physical well-being scores during the camps were comparable between the groups .\
RESULTS	However , salivary SIgA secretion rate changes were different between these groups .\
RESULTS	Salivary SIgA secretion rates decreased during the camp in the placebo group ( before vs. second , middle , and final day of camp , and after the camp : 146 89 vs. 87 56 , 70 45 , 94 58 , and 116 71 g/min ) , whereas no such decreases were observed in the chlorella group ( 121 53 vs. 113 68 , 98 69,115 80 , and 128 59 g/min ) .\
CONCLUSIONS	Our results suggest that a use of a chlorella-derived dietary supplement attenuates reduced salivary SIgA secretion during a training camp for a competitive sport .\
\
###10091827\
OBJECTIVE	This study evaluated the effect of the glycoprotein IIb/IIIa ( GPIIb/IIIa ) antagonist abciximab on myocardial hypoperfusion during percutaneous transluminal rotational atherectomy ( PTRA ) .\
BACKGROUND	PTRA may cause transient ischemia and periprocedural myocardial injury .\
BACKGROUND	A platelet-dependent risk of non-Q-wave infarctions after directional atherectomy has been described .\
BACKGROUND	The role of platelets for the incidence and severity of myocardial hypoperfusion during PTRA is unknown .\
METHODS	Seventy-five consecutive patients with complex lesions were studied using resting Tc-99m sestamibi single-photon emission computed tomography prior to PTRA , during , and 2 days after the procedure .\
METHODS	The last 30 patients received periprocedural abciximab ( group A ) and their results were compared to the remaining 45 patients ( group B ) .\
METHODS	For semiquantitative analysis , myocardial perfusion in 24 left ventricular regions was expressed as percentage of maximal sestamibi uptake .\
RESULTS	Baseline characteristics did not differ between the groups .\
RESULTS	Transient perfusion defects were observed in 39/45 ( 87 % ) patients of group B , but only in 10/30 ( 33 % ) patients of group A ( p < 0.001 ) .\
RESULTS	Perfusion was significantly reduced during PTRA in 3.3 + / - 2.5 regions in group B compared to 1.4 + / - 2.5 regions in group A ( p < 0.01 ) .\
RESULTS	Perfusion in the region with maximal reduction during PTRA in groups B and A was 76 + / - 15 % and 76 + / - 15 % at baseline , decreased to 56 + / - 16 % ( p < 0.001 ) and 67 + / - 14 % , respectively , during PTRA ( p < 0.01 A vs. B ) , and returned to 76 + / - 15 % and 80 + / - 13 % , respectively , after PTRA .\
RESULTS	Nine patients in group B ( 20 % ) and two patients in group A ( 7 % ) had mild creatine kinase and/or troponin t elevations ( p = 0.18 ) .\
RESULTS	Patients with elevated enzymes had larger perfusion defects than did patients without myocardial injury ( 4.2 + / - 2.7 vs. 2.3 + / - 2.5 regions , p < 0.05 ) .\
CONCLUSIONS	These data indicate that GPIIb/IIIa blockade reduces incidence , extent and severity of transient hypoperfusion during PTRA .\
CONCLUSIONS	Thus , platelet aggregation may play an important role for PTRA-induced hypoperfusion .\
\
###15014297\
BACKGROUND	Antipyretics reduce the prolonged , high fever characteristic of typhoid fever .\
BACKGROUND	The benefits of nonsteroidal drugs in this role have not been quantified .\
BACKGROUND	There have been concerns about the safety of antipyretics in typhoid .\
METHODS	In a double blind randomized study , 80 Vietnamese children with uncomplicated typhoid fever were randomized to receive identical syrup preparations of ibuprofen ( 10 mg/kg ) or paracetamol ( 12 mg/kg ) every 6 h until 36 h after defervescence .\
METHODS	Children with a nalidixic acid-susceptible ( Na ) isolate of Salmonella typhi were treated with ofloxacin ( 15 mg/kg/day ) for 3 days and those with a nalidixic acid-resistant ( Na ) isolate were treated for 7 days .\
RESULTS	S. typhi was isolated from 36 of 40 children randomized to ibuprofen ( 11 isolates Na ) and 37 of 40 randomized to paracetamol ( 13 isolates Na ) .\
RESULTS	The median ( range ) fever clearance time ( hours ) was shorter in the ibuprofen group than the paracetamol group ( 68 , 4 to 260 vs. 104 , 12 to 404 ; P = 0.055 ) as was the area under the temperature time curve above 37 degree C ( 74 , 0 to 237 vs. 127 , 0 to 573 ; P = 0.013 ) .\
RESULTS	The differences occurred predominantly in the children infected with a NaS .\
RESULTS	typhi whose infections responded more slowly to antibiotic treatment .\
RESULTS	There were no major side effects associated with the use of either drug .\
RESULTS	There were no differences between the two treatment arms in the concentrations of circulating interleukin-6 and tumor necrosis factor alpha during the course of treatment .\
CONCLUSIONS	The antipyretic effect of ibuprofen is superior to that of paracetamol in children with typhoid fever , particularly those with prolonged fever .\
CONCLUSIONS	Both antipyretics appeared to be safe .\
\
###15025216\
BACKGROUND	The primary aim of this randomized , controlled , blinded , clinical investigation was to compare the coronally positioned flap ( CPF ) plus an acellular dermal matrix ( ADM ) allograft to CPF alone to determine their effect on gingival thickness and percent root coverage .\
METHODS	Twenty-four subjects with one Miller Class I or II buccal recession defect of > or = 3 mm were treated with a CPF plus ADM or a CPF alone .\
METHODS	Multiple additional recession sites were treated with the same flap procedure , and all sites were studied for 6 months .\
METHODS	Tissue thickness was measured at the sulcus base and at the mucogingival junction of all teeth , with an SDM ultrasonic gingival thickness meter .\
RESULTS	For the ADM sites , mean initial recession of 3.46 mm was reduced to 0.04 mm for defect coverage of 3.42 mm or 99 % ( P < 0.05 ) .\
RESULTS	For the CPF group , mean initial recession of 3.27 mm was reduced to 1.08 mm for defect coverage of 2.19 mm or 67 % ( P < 0.05 ) .\
RESULTS	The difference between ADM and CPF groups was statistically significant ( P < 0.05 ) .\
RESULTS	Marginal soft-tissue thickness was increased by 0.40 mm ( P < 0.05 ) for the ADM group , whereas the CPF group remained essentially unchanged .\
RESULTS	Keratinized tissue was increased for the ADM group by 0.81 mm ( P < 0.05 ) , whereas the CPF group increased by 0.33 mm ( P > 0.05 ) .\
RESULTS	No additional root coverage was gained due to creeping attachment between 2 and 6 months for either group .\
CONCLUSIONS	Treatment with a CPF plus an ADM allograft significantly increased gingival thickness when compared with a CPF alone .\
CONCLUSIONS	Recession defect coverage was significantly improved with the use of ADM.\
\
###21703071\
OBJECTIVE	Glass ionomer sealants ( GISs ) are promoted in pediatric dentistry for their moisture-friendly properties .\
OBJECTIVE	This study 's purpose was to investigate the marginal leakage of a glass ionomer sealant ( Fuji Triage ) under different moisture environments .\
METHODS	Eighty extracted teeth were distributed into 4 groups : ( 1 ) control ; ( 2 ) saliva contamination with 1-second air-thinning ; ( 3 ) saliva contamination with 10 seconds of air-drying ; and ( 4 ) saliva contamination with reconditioning .\
METHODS	Sealants were placed after contamination .\
METHODS	All extracted teeth underwent thermocycling followed by 1 % methylene blue dye and distilled water wash .\
METHODS	All extracted teeth were then sectioned buccolingually into 3 cross-sections and examined at 60X under a stereomicroscope .\
METHODS	Microleakage was assessed using a dye penetration scoring system ( score = 0-3 ) .\
METHODS	Data were analyzed with Kruskal-Wallis and Mann-Whitney tests .\
RESULTS	The control group showed significantly lower marginal leakage than the other 3 groups ( P < .02 ) .\
RESULTS	There was no statistically significant difference among the 3 contaminated groups ( P > .34 ) .\
CONCLUSIONS	Fuji Triage sealant had the least marginal leakage under a moisture-controlled environment .\
CONCLUSIONS	When saliva was introduced during the application of the material , microleakage significantly increased .\
CONCLUSIONS	When contamination occurred , 1-second air-thinning of the saliva , 10-second air-drying of the saliva , or reconditioning before sealant application did not show a difference in decreasing microleakage .\
\
###23115765\
OBJECTIVE	When a mandibular third molar is partially impacted in the soft tissue , it must be determined whether the extraction wound should be left partially open or completely closed .\
OBJECTIVE	We hypothesize that a blood clot preserving a surgical wound with easily cleanable surfaces by primary closure and drain application would postoperatively minimize dry socket and/or alveolitis development .\
METHODS	Twenty patients requiring bilateral extraction of partially soft tissue-impacted mandibular third molars in a vertical position were included in the study .\
METHODS	The existence of dry sockets , alveolitis , pain , facial swelling , and trismus were evaluated on the second , fifth , and seventh days of the postoperative period .\
RESULTS	On the second day , pain , trismus , and swelling were higher in the drained group ; however , pain reduced progressively in the drained group over time .\
RESULTS	There were no cases of dry sockets or alveolitis except for a single patient on the seventh day in the drained group over the 7-day study period .\
RESULTS	On the other hand , in the secondary closure group , the number of dry sockets was 8 ( 40 % ) on the second day .\
RESULTS	The number of alveolitis was 10 ( 50 % ) on the fifth day and 4 ( 20 % ) on the seventh day .\
CONCLUSIONS	Closed healing by drain insertion after removal of partially soft tissue-impacted third molars produces less frequent postoperative dry sockets and/or alveolitis development than occurs with open healing of the surgical wound .\
CONCLUSIONS	In cases with a risk of alveolitis development ( lack of oral hygiene , immunocompromised patients , etc ) , it can be avoided with the `` kiddle effect '' and related undesired complications by implementing closed healing with drain insertion .\
\
###21639810\
BACKGROUND	Ipilimumab monotherapy ( at a dose of 3 mg per kilogram of body weight ) , as compared with glycoprotein 100 , improved overall survival in a phase 3 study involving patients with previously treated metastatic melanoma .\
BACKGROUND	We conducted a phase 3 study of ipilimumab ( 10 mg per kilogram ) plus dacarbazine in patients with previously untreated metastatic melanoma .\
METHODS	We randomly assigned 502 patients with previously untreated metastatic melanoma , in a 1:1 ratio , to ipilimumab ( 10 mg per kilogram ) plus dacarbazine ( 850 mg per square meter of body-surface area ) or dacarbazine ( 850 mg per square meter ) plus placebo , given at weeks 1 , 4 , 7 , and 10 , followed by dacarbazine alone every 3 weeks through week 22 .\
METHODS	Patients with stable disease or an objective response and no dose-limiting toxic effects received ipilimumab or placebo every 12 weeks thereafter as maintenance therapy .\
METHODS	The primary end point was overall survival .\
RESULTS	Overall survival was significantly longer in the group receiving ipilimumab plus dacarbazine than in the group receiving dacarbazine plus placebo ( 11.2 months vs. 9.1 months , with higher survival rates in the ipilimumab-dacarbazine group at 1 year ( 47.3 % vs. 36.3 % ) , 2 years ( 28.5 % vs. 17.9 % ) , and 3 years ( 20.8 % vs. 12.2 % ) ( hazard ratio for death , 0.72 ; P < 0.001 ) .\
RESULTS	Grade 3 or 4 adverse events occurred in 56.3 % of patients treated with ipilimumab plus dacarbazine , as compared with 27.5 % treated with dacarbazine and placebo ( P < 0.001 ) .\
RESULTS	No drug-related deaths or gastrointestinal perforations occurred in the ipilimumab-dacarbazine group .\
CONCLUSIONS	Ipilimumab ( at a dose of 10 mg per kilogram ) in combination with dacarbazine , as compared with dacarbazine plus placebo , improved overall survival in patients with previously untreated metastatic melanoma .\
CONCLUSIONS	The types of adverse events were consistent with those seen in prior studies of ipilimumab ; however , the rates of elevated liver-function values were higher and the rates of gastrointestinal events were lower than expected on the basis of prior studies .\
CONCLUSIONS	( Funded by Bristol-Myers Squibb ; ClinicalTrials.gov number , NCT00324155 . )\
\
###25636550\
BACKGROUND	The aim of this study was to compare the esthetic judgments of orthodontists and laypeople regarding the appearance of palatally displaced canines 3 months after treatment with either a closed or an open surgical exposure and orthodontic alignment .\
METHODS	A multicenter randomized controlled trial was undertaken in 3 hospitals in the United Kingdom .\
METHODS	Patients with unilateral palatally displaced canines were randomly allocated to receive either a closed or an open surgical exposure .\
METHODS	The teeth were aligned with fixed appliances , and 3 months after debond , intraoral photographs were taken .\
METHODS	The photographs were projected in random order to 2 panels of judges ( orthodontists and laypeople ) , who completed a questionnaire .\
RESULTS	The images of 67 participants ( closed , 33 ; open , 34 ) were included .\
RESULTS	The laypeople were able to identify the operated tooth only 49.7 % of the time ( 95 % CI , 45.3 % -54.0 % ) ; this was no better than chance ( P = 0.880 ) .\
RESULTS	The orthodontists were more successful but still identified the treated canine with certainty only 60.7 % of the time ( 95 % CI , 53.7 % -67.8 % ; P = 0.003 ) .\
RESULTS	Both panels more frequently assessed the unoperated canine to have a better appearance than the contralateral operated canine ; however , there were no differences between the closed and open groups ( proportion preferring unoperated canine-laypeople : closed , 58.7 % ; open , 57.0 % ; P = 0.43 ; and orthodontists : closed , 60.9 % ; open , 60.6 % ; P = 0.27 ) .\
CONCLUSIONS	There is an esthetic impact to aligning a palatally displaced canine , but it is mostly minor and unlikely to be detectable by laypeople .\
CONCLUSIONS	The esthetic impact was the same , whether the canine was exposed with a closed or an open surgical technique .\
\
###24354833\
OBJECTIVE	We evaluated whether a brief , universal , postnatal nurse home-visiting intervention can be implemented with high penetration and fidelity , prevent emergency health care services , and promote positive parenting by infant age 6 months .\
METHODS	Durham Connects is a manualized 4 - to 7-session program to assess family needs and connect parents with community resources to improve infant health and well-being .\
METHODS	All 4777 resident births in Durham , North Carolina , between July 1 , 2009 , and December 31 , 2010 , were randomly assigned to intervention and control conditions .\
METHODS	A random , representative subset of 549 families received blinded interviews for impact evaluation .\
RESULTS	Of all families , 80 % initiated participation ; adherence was 84 % .\
RESULTS	Hospital records indicated that Durham Connects infants had 59 % fewer infant emergency medical care episodes than did control infants .\
RESULTS	Durham Connects mothers reported fewer infant emergency care episodes and more community connections , more positive parenting behaviors , participation in higher quality out-of-home child care , and lower rates of anxiety than control mothers .\
RESULTS	Blinded observers reported higher quality home environments for Durham Connects than for control families .\
CONCLUSIONS	A brief universal home-visiting program implemented with high penetration and fidelity can lower costly emergency medical care and improve family outcomes .\
\
###15883431\
BACKGROUND	The discovery of equol in human urine more than 2 decades ago and the finding that it is bacterially derived from daidzin , an isoflavone abundant in soy foods , led to the current nutritional interest in soy foods .\
BACKGROUND	Equol , unlike the soy isoflavones daidzein or genistein , has a chiral center and therefore can occur as 2 distinct diastereoisomers .\
OBJECTIVE	Because it was unclear which enantiomer was present in humans , our objectives were to characterize the exact structure of equol , to examine whether the S - and R-equol enantiomers are bioavailable , and to ascertain whether the differences in their conformational structure translate to significant differences in affinity for estrogen receptors .\
METHODS	With the use of chiral-phase HPLC and mass spectrometry , equol was isolated from human urine and plasma , and its enantiomeric structure was defined .\
METHODS	Human fecal flora were cultured in vitro and incubated with daidzein to ascertain the stereospecificity of the bacterial production of equol .\
METHODS	The pharmacokinetics of S - and R - equol were determined in 3 healthy adults after single-bolus oral administration of both enantiomers , and the affinity of each equol enantiomer for estrogen receptors was measured .\
RESULTS	Our studies definitively establish S-equol as the exclusive product of human intestinal bacterial synthesis from soy isoflavones and also show that both enantiomers are bioavailable .\
RESULTS	S-equol has a high affinity for estrogen receptor beta ( K ( i ) = 0.73 nmol/L ) , whereas R-equol is relatively inactive .\
CONCLUSIONS	Humans have acquired an ability to exclusively synthesize S-equol from the precursor soy isoflavone daidzein , and it is significant that , unlike R-equol , this enantiomer has a relatively high affinity for estrogen receptor beta .\
\
###12243915\
BACKGROUND	Three clinical trials on the use of tamoxifen to prevent breast cancer have reported mixed results .\
BACKGROUND	The overall evidence supports a reduction in the risk of breast cancer , but whether this benefit outweighs the risks and side-effects associated with tamoxifen is unclear .\
METHODS	We undertook a double-blind placebo-controlled randomised trial of tamoxifen , 20 mg/day for 5 years , in 7152 women aged 35-70 years , who were at increased risk of breast cancer .\
METHODS	The primary outcome measure was the frequency of breast cancer ( including ductal carcinoma in situ ) .\
METHODS	Analyses were by intention to treat after exclusion of 13 women found to have breast cancer at baseline mammography .\
RESULTS	After median follow-up of 50 months ( IQR 32-67 ) , 69 breast cancers had been diagnosed in 3578 women in the tamoxifen group and 101 in 3566 in the placebo group ( risk reduction 32 % [ 95 % CI 8-50 ] ; p = 0.013 ) .\
RESULTS	Age , degree of risk , and use of hormone-replacement therapy did not affect the reduction .\
RESULTS	Endometrial cancer was non-significantly increased ( 11 vs 5 ; p = 0.2 ) and thromboembolic events were significantly increased with tamoxifen ( 43 vs 17 ; odds ratio 2.5 [ 1.5-4 .4 ] , p = 0.001 ) , particularly after surgery .\
RESULTS	There was a significant excess of deaths from all causes in the tamoxifen group ( 25 vs 11 , p = 0.028 ) .\
CONCLUSIONS	Prophylactic tamoxifen reduces the risk of breast cancer by about a third .\
CONCLUSIONS	Temporary cessation of tamoxifen should be considered and the use of appropriate antithrombotic measures is recommended during and after major surgery or periods of immobilisation .\
CONCLUSIONS	Prophylactic use of tamoxifen is contraindicated in women at high risk of thromboembolic disease .\
CONCLUSIONS	The combined evidence indicates that mortality from non-breast-cancer causes is not increased by tamoxifen .\
CONCLUSIONS	The overall risk to benefit ratio for the use of tamoxifen in prevention is still unclear , and continued follow-up of the current trials is essential .\
\
###23171588\
BACKGROUND	Previous studies had suggested that the outcome for patients with spontaneous lobar intracerebral haemorrhage ( ICH ) and no intraventricular haemorrhage ( IVH ) might be improved with early evacuation of the haematoma .\
BACKGROUND	The Surgical Trial in Lobar Intracerebral Haemorrhage ( STICH II ) set out to establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar ICH would improve outcome compared to a policy of initial conservative treatment .\
BACKGROUND	It is an international , multi-centre , prospective randomised parallel group trial of early surgery in patients with spontaneous lobar ICH .\
BACKGROUND	Outcome is measured at six months via a postal questionnaire .\
RESULTS	Recruitment to the study began on 27 November 2006 and closed on 15 August 2012 by which time 601 patients had been recruited .\
RESULTS	The protocol was published in Trials ( http://www.trialsjournal.com/content/12/1/124/ ) .\
RESULTS	This update presents the analysis plan for the study without reference to the unblinded data .\
RESULTS	The trial data will not be unblinded until after follow-up is completed in early 2013 .\
RESULTS	The main trial results will be presented in spring 2013 with the aim to publish in a peer-reviewed journal at the same time .\
CONCLUSIONS	The data from the trial will provide evidence on the benefits and risks of early surgery in patients with lobar ICH .\
BACKGROUND	ISRCTN : ISRCTN22153967 .\
\
###7634883\
OBJECTIVE	To assess the relationship of distance ambulated during the 6-min walk test ( 6 ` WT ) to maximal oxygen consumption ( VO2 max ) .\
METHODS	Multivariate analysis of patient characteristics to VO2 max .\
METHODS	Pre-lung transplant evaluation .\
METHODS	60 patients ( 22 men , 38 women ; mean age , 44 years ) with end-stage lung disease ( mean FEV1 and forced vital capacity of 0.97 and 1.93 , respectively ) .\
RESULTS	The 6 ` WT was performed on a level hallway surface , and VO2 max was obtained during maximal cycle ergometry exercise testing with respiratory gas analysis .\
RESULTS	Multivariate analysis of patient characteristics ( age , sex , weight , FEV1 , FVC , diffusing capacity for carbon monoxide ( DCO ) , 6 ` WT distance ambulated , number of rests per 6 ` WT , and the maximal heart rate , blood pressure , rate-pressure product , respiratory rate , oxygen saturation , rating of perceived exertion , and amount of supplemental oxygen used during the 6 ` WT ) was performed on two groups of 30 patients each ( group A or B ) who were randomly assigned to either group by a process of random selection using a computer-generated random numbers program .\
RESULTS	Distance ambulated was the strongest independent predictor of VO2 max ( r = 0.73 ; p < 0.0001 ) in both groups , and adding age , weight , and pulmonary function test results ( FVC , FEV1 , and DCO ) to the regression equation increased the correlation coefficient to 0.83 .\
RESULTS	Because of the significant correlation of distance ambulated during the 6 ` WT to VO2 max , the prediction equation obtained from the multivariate analysis of group A , VO2 max = 0.006 x distance ( feet ) +3.38 , was used to estimate the VO2 max of the group B patients .\
RESULTS	No significant difference was observed between the estimated ( x + / - SD = 8.9 + / - 2.4 mL/kg/min ) and observed ( x + / - SD = 9.4 + / - 3.8 mL/kg/min ) VO2 max ( mean difference , 0.5 mL/kg/min ; SD of the difference = 2.88 ) .\
CONCLUSIONS	The distance ambulated during a 6 ` WT can predict VO2 max in patients with end-stage lung disease .\
CONCLUSIONS	The addition of several patient characteristics can increase the ability to predict VO2 max and account for more of the variability .\
CONCLUSIONS	Such information is valuable when assessing patient response to therapeutic intervention if respiratory gas analysis is unavailable or impractical .\
\
###17320580\
OBJECTIVE	Air leakage after pulmonary lobectomy is a well-known problem often contributing to extended hospitalization .\
OBJECTIVE	Many techniques have been proposed to prevent and treat air leakage , but none have been proved incontrovertibly effective .\
OBJECTIVE	We evaluated the role of an autologous blood patch after pulmonary lobectomy .\
METHODS	Twenty-five patients with air leaks on the sixth postoperative day after lobectomy were enrolled in this study .\
METHODS	They were randomly assigned to 2 groups : group A ( 12 patients ) , with 50 mL of autologous blood infused in the pleural cavity ; and group B ( 13 patients ) , with 100 mL of blood infused .\
METHODS	These 2 groups were retrospectively compared with the last 15 patients showing the presence of air leaks for at least 6 days ( group C ) ( in this group the duration of leakage after the sixth postoperative day was compared ) .\
METHODS	We recorded the duration of posttreatment air leaks and hospitalization .\
RESULTS	Air leaks stopped 2.3 + / - 0.6 days after the procedure in group A , 1.5 + / - 0.6 days after the procedure in group B , and after 6.3 + / - 3.7 days in group C.\
RESULTS	The air leakage disappeared within 72 hours in all patients in groups A and B.\
RESULTS	There was a statistically significant difference in the duration of drainage between groups A and B ( P = .005 ) , groups A and C ( P = .0009 ) , and groups B and C ( P = .0001 ) , showing the effectiveness of an autologous blood patch , particularly with 100 mL of blood .\
CONCLUSIONS	Management of air leaks after lobectomy with an autologous blood patch is easy , safe , and effective , and does not add costs .\
CONCLUSIONS	It may become the gold standard treatment early in the postoperative course .\
\
###12208225\
BACKGROUND	The presence of Q waves at presentation with a first acute myocardial infarction reflects a more advanced stage of the infarction process .\
BACKGROUND	When infarct-related artery patency ( Thrombolysis in Myocardial Infarction 2 or 3 flow ) is restored , resolution of ST segment elevation indicating successful myocyte reperfusion may differ according to how far the infarction process has progressed .\
RESULTS	In 144 patients with a first acute myocardial infarction treated with streptokinase in the first Hirulog Early Reperfusion Occlusion trial , information was obtained from continuous ST segment monitoring , the presenting electrocardiogram and early angiography performed at a median time of 99 min after the commencement of streptokinase ( interquartile range 89-108 min ) .\
RESULTS	We determined how many patients had 50 % ST recovery within 120 min and in how many cases it was sustained over 4h .\
RESULTS	In the 109 patients with patent infarct-related arteries , 50 % ST recovery occurred in 95 % of patients without vs 80 % of those with initial Q waves ( P = 0.03 ) , and sustained ST recovery occurred in 67 % of patients without vs 47 % of those with initial Q waves ( P = 0.03 ) .\
RESULTS	On multivariate analysis including the time from symptom onset to streptokinase therapy , the presence of Q waves at presentation was the only predictor of failure to achieve 50 % ST recovery ( odds ratio 5.08 , 95 % confidence interval 1.29-20 .01 , P = 0.02 ) .\
RESULTS	TIMI 2 flow , as opposed to TIMI 3 flow , was the only predictor of failure to achieve stable ST recovery ( odds ratio 2.63 , 95 % confidence interval 1.15-5 .88 , P = 0.02 ) .\
CONCLUSIONS	The presence of initial Q waves predicts slower and less complete ST recovery , reflecting reduced myocyte reperfusion , even in those with early infarct artery patency .\
CONCLUSIONS	These patients may be targeted for new therapeutic strategies to improve microvascular reperfusion .\
\
###7640538\
OBJECTIVE	To compare the effectiveness over three years of chiropractic and hospital outpatient management for low back pain .\
METHODS	Randomised allocation of patients to chiropractic or hospital outpatient management .\
METHODS	Chiropractic clinics and hospital outpatient departments within reasonable travelling distance of each other in 11 centres .\
METHODS	741 men and women aged 18-64 years with low back pain in whom manipulation was not contraindicated .\
METHODS	Change in total Oswestry questionnaire score and in score for pain and patient satisfaction with allocated treatment .\
RESULTS	According to total Oswestry scores improvement in all patients at three years was about 29 % more in those treated by chiropractors than in those treated by the hospitals .\
RESULTS	The beneficial effect of chiropractic on pain was particularly clear .\
RESULTS	Those treated by chiropractors had more further treatments for back pain after the completion of trial treatment .\
RESULTS	Among both those initially referred from chiropractors and from hospitals more rated chiropractic helpful at three years than hospital management .\
CONCLUSIONS	At three years the results confirm the findings of an earlier report that when chiropractic or hospital therapists treat patients with low back pain as they would in day to day practice those treated by chiropractic derive more benefit and long term satisfaction than those treated by hospitals .\
\
###24456716\
OBJECTIVE	This study sought to evaluate the safety and efficacy of the Lutonix drug-coated balloon ( DCB ) coated with 2 g/mm ( 2 ) paclitaxel and a polysorbate/sorbitol carrier for treatment of femoropopliteal lesions .\
BACKGROUND	Percutaneous treatment of peripheral vascular disease is associated with a high recurrence .\
BACKGROUND	Paclitaxel-coated balloons at 3 g/mm ( 2 ) formulated differently have shown promising results with reduced restenosis .\
BACKGROUND	Methods Subjects at 9 centers with Rutherford class 2 to 5 femoropopliteal lesions were randomized between June 2009 and December 2009 to treatment with Lutonix DCB ( n = 49 ) versus uncoated balloons ( control group [ n = 52 ] ) , stratified by whether balloon-only treatment ( n = 75 ) or stenting ( n = 26 ) was intended .\
BACKGROUND	The primary endpoint was angiographic late lumen loss at 6 months .\
BACKGROUND	Secondary outcomes included adjudicated major adverse events ( death , amputation , target lesion thrombosis , reintervention ) , functional outcomes , and pharmacokinetics .\
RESULTS	Demographic , peripheral vascular disease , and lesion characteristics were matched , with mean lesion length of 8.1 3.8 cm and 42 % total occlusions .\
RESULTS	At 6 months , late lumen loss was 58 % lower for the Lutonix DCB group ( 0.46 1.13 mm ) than for the control group ( 1.09 1.07 mm ; p = 0.016 ) .\
RESULTS	Composite 24-month major adverse events were 39 % for the DCB group , including 15 target lesion revascularizations , 1 amputation , and 4 deaths versus 46 % for uncoated balloon group , with 20 target lesion revascularizations , 1 thrombosis , and 5 deaths .\
RESULTS	Pharmacokinetics showed biexponential decay with peak concentration ( Cmax ) of 59 ng/ml and total observed exposure ( AUC ( all ) ) of 73 ng h/ml .\
RESULTS	For successful DCB deployment excluding 8 malfunctions , 6-month late lumen loss was 0.39 mm and the 24-month target lesion revascularization rate was 24 % .\
CONCLUSIONS	Treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty .\
CONCLUSIONS	( LEVANT I , The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis ; NCT00930813 )\
\
###16937760\
BACKGROUND	It remains controversial whether pediatric adenotonsillectomy ultimately results in decreased serum immunoglobulin levels and if so whether such a decrease is associated with increased susceptibility to upper respiratory tract infections ( URIs ) .\
OBJECTIVE	To evaluate changes in serum immunoglobulin levels in relation to occurrence of URIs in children participating in a randomized controlled trial on the effectiveness of adenotonsillectomy .\
METHODS	A total of 300 children aged 2 to 8 years , with symptoms of recurrent throat infections or tonsillar hypertrophy , were randomly assigned to either adenotonsillectomy or watchful waiting ( WW ) .\
METHODS	Serum samples were collected at baseline and at 1-year follow-up .\
METHODS	Occurrence of throat infections and other URIs during first-year follow-up was recorded in a diary by the child 's parents .\
RESULTS	Paired serum samples were available for 123 children ( 63 in the adenotonsillectomy group and 60 in the WW group ) .\
RESULTS	IgG1 and IgG2 levels decreased but remained within the reference range for age in both study arms .\
RESULTS	IgM and IgA levels decreased as well but remained elevated .\
RESULTS	The IgA level in the adenotonsillectomy group decreased in significantly greater degree compared with the WW group , but this difference disappeared in cases where children experienced frequent URIs .\
RESULTS	In general , no relation between immunoglobulin levels and the number of throat infections or URIs at 1-year follow-up was found .\
CONCLUSIONS	Immunoglobulin levels of children undergoing adenotonsillectomy decreased from elevated to slightly elevated or reference values for age during 1-year follow-up irrespective of treatment ( adenotonsillectomy or WW ) .\
CONCLUSIONS	IgA showed a greater decrease in the adenotonsillectomy group but rose to levels comparable with the WW group in cases of frequent URIs .\
CONCLUSIONS	This finding indicates that the remaining mucosa-associated lymphoid tissue can compensate for the loss of tonsil and adenoid tissue .\
\
###19081527\
OBJECTIVE	Crohn 's disease ( CD ) is associated with altered bone metabolism .\
OBJECTIVE	This study examined changes in bone formation and resorption after infliximab induction and associations between bone biomarkers , linear growth , and disease activity ( Pediatric Crohn 's Disease Activity Index [ PCDAI ] ) after 54 weeks of infliximab therapy .\
METHODS	One hundred twelve subjects ages 6-17 years with moderate to severe CD received infliximab induction ( 5 mg/kg/dose ) at weeks 0 , 2 , and 6 ; week-10 responders were randomized to infliximab every 8 or every 12 weeks maintenance therapy .\
METHODS	Serum bone-specific alkaline phosphatase ( BSAP ) , N-terminal propeptide of type 1 collagen ( P1NP ) , urine C-telopeptide of collagen cross-links ( CTX-1 ) , and deoxypyrodinoline ( DPD ) were collected at baseline and 10 weeks .\
METHODS	PCDAI and height z-scores were assessed at baseline and at 10 and 54 weeks .\
RESULTS	Models were adjusted for bone age , gender , height , and steroid use .\
RESULTS	Baseline BSAP and P1NP levels were negatively associated with PCDAI ( both P = .01 ) .\
RESULTS	BSAP and P1NP increased during induction ( both P < .001 ) and were associated with 54-week increases in height z-score ( P < .05 and P < .001 , respectively ) .\
RESULTS	Improvements in P1NP were associated with 54-week decreases in PCDAI ( P = .01 ) .\
RESULTS	CTX-1 and DPD also increased during induction ( P < .001 and P = .01 , respectively ) but were not associated with changes in PCDAI .\
RESULTS	Changes in CTX-1 were associated with improvements in height z-score ( P < .002 ) .\
CONCLUSIONS	Infliximab therapy is associated with dramatic increases in BSAP and P1NP , consistent with inhibition of tumor necrosis factor-alpha effects on osteoblasts .\
CONCLUSIONS	The increases in CTX-1 and DPD likely reflect coupling of bone formation and resorption and increases in linear growth .\
\
###15364322\
OBJECTIVE	This study was done to assess and compare the prognostic significance of multiple methods for measuring ST-segment elevation resolution ( STR ) following primary percutaneous coronary intervention ( PCI ) .\
BACKGROUND	Resolution of ST-segment elevation ( STE ) is a powerful predictor of both infarct-related artery patency and mortality in acute myocardial infarction ( AMI ) .\
BACKGROUND	Recent thrombolytic studies have suggested that simple measures of STR may be as powerful as more complex algorithms .\
BACKGROUND	The optimal method of assessing STR following primary PCI has not been studied .\
METHODS	We analyzed 700 patients with technically adequate baseline and post-PCI electrocardiograms from the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications ( CADILLAC ) trial .\
METHODS	Five methods were used to assess STR : 1 ) summed % STR across multiple leads ( SigmaSTR ) ; 2 ) % STR in the single lead with maximum baseline STE ( MaxSTR ) ; 3 ) absolute maximum STE before the procedure ; 4 ) absolute maximum STE after intervention ( MaxSTPost ) ; and 5 ) a categorical variable based upon MaxSTPost ( High Risk ) .\
RESULTS	At 30 days , SigmaSTR , MaxSTR , and MaxSTPost all correlated strongly with mortality ( p = 0.004 , p = 0.005 , and p < 0.0001 , respectively ) and the combined end point of mortality or reinfarction ( p = 0.001 , p = 0.001 , and p < 0.0001 ) .\
RESULTS	At one year , SigmaSTR and MaxSTPost correlated with mortality ( p = 0.04 , p = 0.0001 ) , reinfarction ( p = 0.02 , p = 0.0015 ) , and the combined end point ( p = 0.02 , p < 0.0001 ) .\
RESULTS	By multivariate analysis , only the simpler measures of MaxSTPost and High Risk categorization independently predicted all outcomes at both time points .\
CONCLUSIONS	The STR following primary PCI in AMI correlates strongly with mortality and reinfarction , independent of target vessel patency .\
CONCLUSIONS	The simple measure of the maximal residual degree of STE after primary PCI is a strong independent predictor of both survival and freedom from reinfarction at 30 days and 1 year .\
\
###22150569\
BACKGROUND	Intestinal microbiota manipulation , one of the pathogenetic components of inflammatory bowel disease ( IBD ) , has become an attractive therapy for ulcerative colitis ( UC ) .\
OBJECTIVE	To assess in children with active distal UC the effectiveness of Lactobacillus ( L ) reuteri ATCC 55730 enema on inflammation and cytokine expression of rectal mucosa .\
METHODS	A total of 40 patients ( median age : 7.2 years range 6-18 ) with mild to moderate UC were enrolled in a prospective , randomised , placebo-controlled study .\
METHODS	They received an enema solution containing 10 ( 10 ) CFU of L. reuteri ATCC 55730 or placebo for 8 weeks , in addition to oral mesalazine .\
METHODS	Clinical endoscopic and histological scores as well as rectal mucosal expression levels of IL-10 , IL-1 , TNF and IL-8 were evaluated at the beginning and at the end of the trial .\
RESULTS	Thirty-one patients accomplished the trial ( 17 males , median age 13 year , range 7-18 ) .\
RESULTS	Mayo score ( including clinical and endoscopic features ) decreased significantly in the L. reuteri group ( 3.2 1.3 vs. 8.6 0.8 , P < 0.01 ) compared with placebo ( 7.1 1.1 vs. 8.7 0.7 , NS ) ; furthermore , histological score significantly decrease only in the L. reuteri group ( 0.6 0.5 vs. 4.5 0.6 , P < 0.01 ) ( placebo : 2.9 0.8 vs. 4.6 0.6 , NS ) .\
RESULTS	At the post-trial evaluation of cytokine mucosal expression levels , IL-10 significantly increased ( P < 0.01 ) whereas IL-1 , TNF and IL-8 significantly decreased ( P < 0.01 ) only in the L. reuteri group .\
CONCLUSIONS	In children with active distal ulcerative colitis , rectal infusion of L. reuteri is effective in improving mucosal inflammation and changing mucosal expression levels of some cytokines involved in the mechanisms of inflammatory bowel disease .\
\
###23446891\
BACKGROUND	The Western diet increases risk of metabolic disease .\
OBJECTIVE	We determined whether lowering the ratio of saturated fatty acids to monounsaturated fatty acids in the Western diet would affect physical activity and energy expenditure .\
METHODS	With the use of a balanced design , 2 cohorts of 18 and 14 young adults were enrolled in separate randomized , double-masked , crossover trials that compared a 3-wk high-palmitic acid diet ( HPA ; similar to the Western diet fat composition ) to a low-palmitic acid and high-oleic acid diet ( HOA ; similar to the Mediterranean diet fat composition ) .\
METHODS	All foods were provided by the investigators , and the palmitic acid ( PA ) : oleic acid ( OA ) ratio was manipulated by adding different oil blends to the same foods .\
METHODS	In both cohorts , we assessed physical activity ( monitored continuously by using accelerometry ) and resting energy expenditure ( REE ) .\
METHODS	To gain insight into a possible mood disturbance that might explain changes in physical activity , the Profile of Mood States ( POMS ) was administered in cohort 2 .\
RESULTS	Physical activity was higher during the HOA than during the HPA in 15 of 17 subjects in cohort 1 ( P = 0.008 ) ( mean : 12 % higher ; P = 0.003 ) and in 12 of 12 subjects in the second , confirmatory cohort ( P = 0.005 ) ( mean : 15 % higher ; P = 0.003 ) .\
RESULTS	When the HOA was compared with the HPA , REE measured during the fed state was 3 % higher for cohort 1 ( P < 0.01 ) , and REE was 4.5 % higher in the fasted state for cohort 2 ( P = 0.04 ) .\
RESULTS	POMS testing showed that the anger-hostility score was significantly higher during the HPA ( P = 0.007 ) .\
CONCLUSIONS	The replacement of dietary PA with OA was associated with increased physical activity and REE and less anger .\
CONCLUSIONS	Besides presumed effects on mitochondrial function ( increased REE ) , the dietary PA : OA ratio appears to affect behavior .\
CONCLUSIONS	The second cohort was derived from a study that was registered at clinicaltrials.gov as R01DK082803 .\
\
###18505968\
BACKGROUND	Taxanes are among the most active drugs for the treatment of metastatic breast cancer , and , as a consequence , they have also been studied in the adjuvant setting .\
METHODS	After breast cancer surgery , women with lymph node-positive disease were randomly assigned to treatment with fluorouracil , epirubicin , and cyclophosphamide ( FEC ) or with FEC followed by weekly paclitaxel ( FEC-P ) .\
METHODS	The primary endpoint of study-5-year disease-free survival ( DFS ) - was assessed by Kaplan-Meier analysis .\
METHODS	Secondary endpoints included overall survival and analysis of the prognostic and predictive value of clinical and molecular ( hormone receptors by immunohistochemistry and HER2 by fluorescence in situ hybridization ) markers .\
METHODS	Associations and interactions were assessed with a multivariable Cox proportional hazards model for DFS for the following covariates : age , menopausal status , tumor size , lymph node status , type of chemotherapy , tumor size , positive lymph nodes , HER2 status , and hormone receptor status .\
METHODS	All statistical tests were two-sided .\
RESULTS	Among the 1246 eligible patients , estimated rates of DFS at 5 years were 78.5 % in the FEC-P arm and 72.1 % in the FEC arm ( difference = 6.4 % , 95 % confidence interval [ CI ] = 1.6 % to 11.2 % ; P = .006 ) .\
RESULTS	FEC-P treatment was associated with a 23 % reduction in the risk of relapse compared with FEC treatment ( 146 relapses in the 614 patients in the FEC-P arm vs 193 relapses in the 632 patients in the FEC arm , hazard ratio [ HR ] = 0.77 , 95 % CI = 0.62 to 0.95 ; P = .022 ) and a 22 % reduction in the risk of death ( 73 and 95 deaths , respectively , HR = 0.78 , 95 % CI = 0.57 to 1.06 ; P = .110 ) .\
RESULTS	Among the 928 patients for whom tumor samples were centrally analyzed , type of chemotherapy ( FEC vs FEC-P ) ( P = .017 ) , number of involved axillary lymph nodes ( P < .001 ) , tumor size ( P = .020 ) , hormone receptor status ( P = .004 ) , and HER2 status ( P = .006 ) were all associated with DFS .\
RESULTS	We found no statistically significant interaction between HER2 status and paclitaxel treatment or between hormone receptor status and paclitaxel treatment .\
CONCLUSIONS	Among patients with operable breast cancer , FEC-P treatment statistically significantly reduced the risk of relapse compared with FEC as adjuvant therapy .\
\
###15386949\
OBJECTIVE	To investigate whether acute dipterex poisoning ( ADP ) may cause oxidative stress and free radical damage in the bodies of acute dipterex poisoning patients ( ADPPs ) , and to explore the mechanisms by which ADP may cause oxidative stress and free radical damage .\
METHODS	Fifty ADPPs and fifty healthy adult volunteers ( HAVs ) whose ages , gender and others were matched with the ADPPs were enrolled in a randomized controlled study , in which concentrations of nitric oxide ( NO ) , vitamin C ( VC ) , vitamin E ( VE ) and beta-carotene ( beta-CAR ) in plasma as well as concentration of lipoperoxide ( LPO ) , and activities of superoxide dismutase ( SOD ) , catalase ( CAT ) , glutathione peroxidase ( GPX ) and acetylcholinesterase ( AChE ) in erythrocytes were determined by spectrophotometric analytical methods .\
RESULTS	Compared with the average values of experimental parameters in the HAVs group , the average values of plasma NO and erythrocyte LPO in the ADPPs group were significantly increased ( P < 0.0001 ) , while those of plasma VC , VE and beta-CAR as well as erythrocyte SOD , CAT , GPX and AChE in the ADPPs group were significantly decreased ( P < 0.0001 ) .\
RESULTS	Bivariate correlation analysis and partial correlation analysis suggested that when NO and LPO values were increased , and VC , VE , beta-CAR , SOD , CAT and GPX values were decreased in the ADPPs , AChE value was decreased gradually in the ADPPs ( P < 0.001-0 .0001 ) .\
RESULTS	Reliability analysis of experimental parameters reflecting oxidative stress and free radical damage in the ADPPs showed that the reliability coefficient ( 8 items ) alpha = 0.6909 , and the standardized item alpha = 0.8574 .\
CONCLUSIONS	The findings in the present study suggest that ADP can cause oxidative stress and free radical damage , and inhibit markedly erythrocyte acetylcholinesterase activity in ADPPs .\
\
###9805346\
OBJECTIVE	To examine whether low-dose aspirin ( 325 mg on alternate days ) reduces the risk of age-related cataract and subtypes .\
OBJECTIVE	This report extends previous findings , including both subtypes and additional newly identified incident cases since the earlier report .\
METHODS	All 20,979 participants in the Physicians ' Health Study , a randomized trial of aspirin and beta-carotene among U.S. male physicians age 40-84 in 1982 , who did not report cataract at baseline were included .\
METHODS	Average follow-up was five years .\
METHODS	The main outcome measure was incident , age-related cataract responsible for a reduction in best-corrected visual acuity to 20/30 or worse , based on self-report confirmed by medical record review .\
RESULTS	501 age-related cataracts were diagnosed during follow-up , including 416 with nuclear sclerosis and 212 with a posterior subcapsular component ; 318 cataracts progressed to surgical extraction .\
RESULTS	Overall , there were 245 cataracts in the aspirin group and 256 in the placebo group ( relative risk [ RR ] , 0.94 ; 95 % confidence interval [ CI ] , 0.79 to 1.13 ; P = 0.52 ) .\
RESULTS	Cataract extractions were 19 % less frequent in the aspirin than in the placebo group ( RR , 0.81 ; 95 % CI , 0.65 to 1.01 ; P = 0.06 ) .\
RESULTS	In subgroup analyses of subtypes , aspirin takers had a lower risk of posterior subcapsular cataract ( RR , 0.74 ; 95 % CI , 0.57 to 0.98 ; P = 0.03 ) but not nuclear sclerosis ( RR , 0.96 ; 95 % CI , 0.79 to 1.16 ; P = 0.65 ) cataract .\
CONCLUSIONS	Overall , these randomized trial data tend to exclude a large benefit of five years of low-dose aspirin therapy on cataract development and extraction .\
CONCLUSIONS	The data are compatible with a modest benefit on cataract extraction for this duration of aspirin therapy .\
CONCLUSIONS	Subgroup analyses raise the possibility of a modest , but potentially important , protective effect of aspirin on posterior subcapsular cataract , a particularly disabling subtype .\
\
###24366792\
OBJECTIVE	To compare the outcome in patients who underwent surgery for unstable intertrochanteric femoral fractures using the proximal femoral locking plate versus the dynamic hip screw ( DHS ) .\
METHODS	15 men and 5 women aged 32 to 78 ( mean , 55 ) years were randomised to the proximal femoral locking plate group , whereas 14 men and 6 women aged 38 to 75 ( mean , 59 ) years were randomised to the conventional 135-degree DHS group .\
METHODS	The time to union , medialisation of the shaft , neck-shaft angle , limb shortening , varus collapse , and functional outcome ( using the Hospital for Special Surgery Hip Rating System ) were assessed .\
RESULTS	Respectively in the locking plate and DHS groups , the mean times to union were 14.6 and 16.5 weeks ( p = 0.067 ) and the mean limb shortenings were 0.3 and 1.4 cm ( p < 0.001 ) .\
RESULTS	Medialisation of the shaft occurred in 0 and 15 patients ( p < 0.0001 ) ; varus collapse occurred in 2 and 5 patients ( p = 0.408 ) ; the functional hip score was good-to-excellent in 18 and 11 patients ( p = 0.031 ) ; deep wound infection occurred in 3 and 2 patients ; and implant cut-out occurred in one patient each group .\
CONCLUSIONS	A non-collapsing locking plate achieved bone union in unstable intertrochanteric fractures with lower risks of limb shortening and medialisation of the shaft .\
\
###1607916\
OBJECTIVE	A randomized clinical trial was undertaken to compare the therapeutic effectiveness of idarubicin ( IDR ) to daunorubicin ( DNR ) , and both were given in combination with cytarabine ( CA ) in acute myelogenous leukemic ( AML ) patients .\
METHODS	Newly diagnosed patients were given a daily infusion of CA ( 100 mg/m2 ) for 7 days and were assigned randomly to receive DNR ( 45 mg/m2 ) or IDR ( 12 mg/m2 ) daily for the first 3 days .\
METHODS	Those patients who achieved a complete remission ( CR ) were given three consolidation courses that consisted of CA ( 100 mg/m2 intravenously [ IV ] ) and thioguanine ( TG ; 100 mg/m2 orally ) every 12 hours for 5 days and either DNR ( 50 mg/m2 ) or IDR ( 15 mg/m2 ) on the first day of each cycle .\
METHODS	After consolidation , patients received late intensification , which consisted of the same drugs used for induction except that the CA was given for 5 days and the anthracycline for 2 days .\
METHODS	Four courses were planned at 13-week intervals .\
RESULTS	The CR rates were 75 of 105 ( 71 % ) on the IDR arm and 65 of 113 ( 58 % ) on the DNR arm ( P = .03 ) .\
RESULTS	The median survival and median remission durations were 297 and 433 days , respectively , on the IDR arm .\
RESULTS	The median survival and median remission durations were 277 and 328 days , respectively , on the DNR arm .\
RESULTS	Six deaths occurred during late intensification , five on IDR and one on DNR ; this approach was abandoned after 47 patients were entered .\
RESULTS	The median survival was significantly longer for patients who received late intensification .\
CONCLUSIONS	This trial demonstrated that IDR was more effective than DNR in remission induction in AML .\
\
###24786582\
BACKGROUND	Novel interventions are needed to improve adherence to treatment in adolescents with type 1 diabetes .\
BACKGROUND	In this article , we describe the development , feasibility , and acceptability of a positive psychology intervention for this population .\
METHODS	Adolescents and their parents ( n = 39 ) were randomly assigned to either a positive psychology intervention or an attention control group .\
METHODS	Quantitative and qualitative data were collected on feasibility and acceptability .\
METHODS	Descriptive and content analysis methods were used .\
RESULTS	Recruitment was successful , participation and satisfaction were high in both groups , and retention was excellent over 6months .\
RESULTS	In the positive psychology group , adolescents and their parents noted benefits related to increased positive communication and thinking more about diabetes care .\
RESULTS	We also identified challenges to implementation .\
CONCLUSIONS	Although more research is indicated , a positive psychology framework emphasizing positive emotions and strengths , rather than problems , may be beneficial to adolescents living with a complex chronic illness .\
\
###25379845\
OBJECTIVE	To determine whether regional hyperthermia ( RHT ) in addition to chemotherapy improves local tumor control after macroscopically complete resection of abdominal or retroperitoneal high-risk sarcomas .\
BACKGROUND	Within the prospectively randomized EORTC 62961 phase-III trial , RHT and systemic chemotherapy significantly improved local progression-free survival ( LPFS ) and disease-free survival ( DFS ) in patients with abdominal and extremity sarcomas .\
BACKGROUND	That trial included macroscopically complete and R2 resections .\
METHODS	A subgroup analysis of the EORTC trial was performed and long-term survival determined .\
METHODS	From 341 patients , 149 ( median age 52 years , 18-69 ) were identified with macroscopic complete resection ( R0 , R1 ) of abdominal and retroperitoneal soft-tissue sarcomas ( median diameter 10 cm , G2 48.3 % , G3 51.7 % ) .\
METHODS	Seventy-six patients were treated with EIA ( etoposide , ifosfamide , doxorubicin ) + RHT ( 5 cycles : 69.7 % ) versus 73 patients receiving EIA alone ( 5 cycles : 52.1 % , P = 0.027 ) .\
METHODS	LPFS and DFS as well as overall survival were determined .\
RESULTS	RHT and systemic chemotherapy significantly improved LPFS ( 56 % vs 45 % after 5 years , P = 0.044 ) and DFS ( 34 % vs 27 % after 5 years , P = 0.040 ) .\
RESULTS	Overall survival was not significantly improved in the RHT group ( 57 % vs 55 % after 5 years , P = 0.82 ) .\
RESULTS	Perioperative morbidity and mortality were not significantly different between groups .\
CONCLUSIONS	In patients with macroscopically complete tumor resection , RHT in addition to chemotherapy resulted in significantly improved local tumor control and DFS without increasing surgical complications .\
CONCLUSIONS	Within a multimodal therapeutic concept for abdominal and retroperitoneal high-risk sarcomas , RHT is a treatment option beside radical surgery and should be further evaluated in future trials .\
\
###1848679\
BACKGROUND	Cytomegalovirus ( CMV ) - associated interstitial pneumonia is a major cause of death after allogeneic bone marrow transplantation .\
BACKGROUND	We conducted a controlled trial of ganciclovir in recipients of bone marrow transplants who had asymptomatic pulmonary CMV infection .\
BACKGROUND	We also sought to identify risk factors for the development of CMV interstitial pneumonia .\
METHODS	After bone marrow transplantation , 104 patients who had no evidence of respiratory disease underwent routine bronchoalveolar lavage on day 35 .\
METHODS	The 40 patients who had positive cultures for CMV were randomly assigned to either prophylactic ganciclovir or observation alone .\
METHODS	Ganciclovir ( 5 mg per kilogram of body weight intravenously ) was given twice daily for two weeks and then five times per week until day 120 .\
RESULTS	Of the 20 culture-positive patients who received prophylactic ganciclovir , 5 ( 25 percent ) died or had CMV pneumonia before day 120 , as compared with 14 of the 20 culture-positive control patients ( 70 percent ) who were not treated prophylactically ( relative risk , 0.36 ; P = 0.01 ) .\
RESULTS	No patient who received the full course of ganciclovir prophylaxis went on to have CMV interstitial pneumonia .\
RESULTS	Four patients treated with ganciclovir had maximal serum creatinine levels greater than or equal to 221 mumol per liter ( 2.5 mg per deciliter ) , as compared with none of the controls ( P = 0.029 ) .\
RESULTS	Of the 55 CMV-negative patients who could be evaluated , 12 ( 22 percent ) had CMV pneumonia -- a significantly lower rate than in the untreated CMV-positive control patients ( relative risk , 0.33 ; P = 0.003 ) .\
RESULTS	The strongest predictors of CMV pneumonia were a lavage-fluid culture that was positive for CMV and a CMV-positive blood culture , both from specimens obtained on day 35 .\
CONCLUSIONS	In recipients of allogeneic bone marrow , asymptomatic CMV infection of the lung is a major risk factor for subsequent CMV interstitial pneumonia .\
CONCLUSIONS	Prophylactic ganciclovir is effective in preventing the development of CMV interstitial pneumonia in patients with asymptomatic infection .\
\
###15983523\
OBJECTIVE	To compare concentrations of factor VII coagulant activity ( factor VIIc ) , fibrinogen , plasminogen activator inhibitor-1 , and blood lipids on a saturated fat-rich diet with one rich in monounsaturated fat .\
METHODS	Subjects were randomly allocated to two groups .\
METHODS	The study design was an ABB/BAA extra-period crossover .\
METHODS	One group consumed a diet rich in saturated fatty acid ( SFA ) with fat making up 20.8 % of total energy , for 5 weeks and then one rich in monounsaturated fatty acid ( MUFA ) , with fat making up 20.3 % of total energy for 10 weeks .\
METHODS	The other group consumed the MUFA diet for 5 weeks followed by the SFA diet for 10 weeks .\
METHODS	Men and women aged 35 to 69 years who were nonsmokers with no chronic illness and not on any medication were recruited to participate .\
METHODS	Eighteen subjects were recruited and 15 ( 5 men , 10 women ) completed the community-based study .\
METHODS	Blood was sampled at the beginning and end point of each 5-week diet period for analysis of coagulation and fibrinolysis factors and blood lipids .\
METHODS	Subjects kept 3-day food diaries twice during each of the three diet periods and were weighed on each visit for blood collection .\
METHODS	Analysis of plasma fatty acids was used to indicate dietary compliance .\
METHODS	Differences in fasting factor VIIc , fibrinogen , plasminogen activator inhibitor-1 , insulin , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , triglycerides , apolipoproteins A-1 and B , and plasma oleic acid levels while receiving the SFA diet vs MUFA diet .\
METHODS	A general linear model allowing for the ABB/BAA extra-period crossover , was used for each of the outcome measures .\
RESULTS	Factor VIIc was lower on the MUFA diet ( P < .05 ) but fibrinogen and insulin concentrations and plasminogen activator inhibitor-1 activity did not differ between diets .\
RESULTS	Low-density lipoprotein cholesterol ( P < .001 ) and triglyceride ( P < .01 ) levels were lower on the MUFA diet compared with the SFA diet .\
RESULTS	A significant increase in both plasma phospholipid and neutral lipid oleic acid ( P < .0001 ) occurred on the MUFA diet .\
CONCLUSIONS	Substitution of foods rich in saturated fat with foods rich in high-oleic-acid sunflower oil and margarine has favorable outcomes on blood lipids and factor VIIc .\
CONCLUSIONS	This oil presents another useful source of MUFA for diets aimed at prevention of heart disease .\
\
###24761912\
BACKGROUND	Retinoblastoma is a rare malignant intraocular neoplasm .\
BACKGROUND	About 90 % of cases feature a germline mutation in the RB1 gene and these will develop retinoblastoma during their early childhood .\
BACKGROUND	An association between mutations in germline cells and aging has been demonstrated .\
BACKGROUND	This suggests a higher incidence of childhood cancer including retinoblastoma among children of older parents .\
METHODS	In the present study we aimed to determine the association of paternal and maternal age with an increased risk of retinoblastoma in a case-control study in Iranian population .\
METHODS	The study was carried out on 240 persons who were born during 1984-2012 in Mahak and Mofid hospitals in Tehran , Iran .\
METHODS	The statistical analysis included studying the mean age of parents and in order to know whether parental age of patients is different from parental age of control group , ( t-test ) compare averages test is used perfectly .\
METHODS	By binary logistic regression , odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) were calculated .\
RESULTS	The results of statistical analysis including the study of mean parental age by the use of ( t-test ) compare averages test showed a significant difference between parental ages of patients and controls .\
RESULTS	Logistic regression showed that coefficients were significant for maternal but not paternal age .\
CONCLUSIONS	Our findings indicate that advanced maternal age can increase the risk of retinoblastoma in offspring , but the paternal age has no significant effect .\
\
###11168029\
OBJECTIVE	A prospective assessment of the pharyngeal colonization prevalence rates for Streptococcus pyogenes and Streptococcus pneumoniae before and after an azithromycin chemoprophylaxis intervention clinical trial in a cohort of US Marine Corps trainees .\
OBJECTIVE	In addition , the minimum inhibitory concentrations ( MICs ) for all streptococcal isolates , for azithromycin , penicillin , erythromycin and cefotaxime are reported .\
METHODS	Between November 1994 and March 1995 , 1108 asymptomatic male US Marine Corps trainees , located in Southern California , were randomly assigned to one of three intervention groups : ( 1 ) weekly oral azithromycin , 500 mg ( n = 362 ) ; ( 2 ) 1.2 MU benzathine penicillin G , intramuscularly once ( n = 374 ) ; or ( 3 ) no chemoprophylaxis ( n = 372 ) .\
METHODS	Subjects provided both a pre - and post-training pharyngeal culture and microbial analysis was conducted to determine the colonization status of each study subject .\
RESULTS	The pretraining colonization prevalence was 1.2 % for S. pneumoniae and 2.4 % for S. pyogenes .\
RESULTS	There was no statistical difference in pretraining prevalence between the three treatment groups for either organism .\
RESULTS	Post-training pharyngeal cultures revealed an overall prevalence of 1.1 % with no difference between treatment arms .\
RESULTS	However , the overall post-training prevalence of S. pyogenes colonization increased to 4.8 % , with the azithromycin group having significant evidence of protection ( 0.7 % ) in comparison with the no-treatment group ( 8.2 % ) .\
RESULTS	The Etest method demonstrated no significant difference in the MIC50 , MIC90 , and MIC ranges between pre - and post-training isolates for any of the tested drugs .\
CONCLUSIONS	The use of azithromycin as a chemoprophylactic agent to reduce the colonization and subsequent infection of streptococcal respiratory disease among healthy adult male military recruits may be beneficial .\
\
###12045508\
METHODS	A multicenter randomized study with a 2-year follow-up period and an independent observer was conducted .\
OBJECTIVE	To compare three commonly used surgical techniques to achieve lumbar fusion primarily in terms of their ability to reduce pain and decrease disability in patients with severe chronic low back pain .\
BACKGROUND	Lumbar fusion can be used to reduce pain and decrease disability in patients with chronic low back pain , and different surgical techniques are available .\
BACKGROUND	The reported results after fusion surgery vary considerably , but most studies are retrospective and/or performed on heterogeneous patient groups .\
BACKGROUND	Spine surgeons commonly use the techniques presented in this report .\
BACKGROUND	However , in the absence of randomized trials it is difficult to know whether any one of them is better than the others for these patients .\
METHODS	From 1992 through 1998 , 294 patients referred to 19 spinal centers were blindly randomized into four treatment groups : three surgical groups ( n = 222 ) and one nonsurgical group ( n = 72 ) .\
METHODS	The sociodemographic and clinical characteristics did not differ among the groups .\
METHODS	Eligibility included patients 25 to 65 years of age with therapy-resistant chronic low back pain that had persisted for at least 2 years and radiologic evidence of disc degeneration ( spondylosis ) at L4-L5 , L5-S1 , or both .\
METHODS	Only patients randomized to one of three surgical groups were analyzed in the current study : Group 1 ( posterolateral fusion ; n = 73 ) , Group 2 ( posterolateral fusion combined with variable screw placement , an internal fixation device ; n = 74 ) , and Group 3 ( posterolateral fusion combined with variable screw placement and interbody fusion ; n = 75 ) .\
METHODS	The `` circumferential fusion '' in Group 3 was performed either as an anterior lumbar interbody fusion ( n = 56 ) or as a biomechanically similar posterior lumbar interbody fusion ( n = 19 ) .\
METHODS	The groups were composed of 51 % , 58 % , and 40 % men respectively , and the respective mean ages were 44 , 43 , and 42 years .\
METHODS	The patients had experienced low back pain for at least 2 years ( mean , approximately 8 years ) .\
METHODS	They had been on sick leave for approximately 3 years .\
METHODS	Pain was measured by a visual analog scale , and disability was assessed by the Oswestry Low Back Pain Questionnaire , the Million Visual Analogue Score , and the General Function Score .\
METHODS	Depressive symptoms were measured by the Zung Depression Scale .\
METHODS	The global overall rating of the result was assessed by the patient and an independent observer after 2 years .\
METHODS	Hospitalization data including operation time , blood loss , blood transfusion , and days of hospitalization in connection with surgery were reported , along with complications and the fusion rate .\
METHODS	Records from the Swedish Social Insurance Board providing information on sick leave and economic compensation for Swedish residents were used to evaluate the patients ' work status .\
RESULTS	An independent observer examined 201 ( 91 % ) of 222 patients after 2 years , after 18 `` group changers '' and 3 dropouts had been excluded from the analyses .\
RESULTS	All surgical techniques were found to reduce pain and decrease disability substantially , but no significant differences were found among the groups .\
RESULTS	In all three groups , the patients rated the overall outcome similarly , as did the independent observer .\
RESULTS	The more demanding techniques in Groups 2 and 3 consumed significantly more resources in terms of operation time , blood transfusions , and days in hospital after surgery .\
RESULTS	The early complication rate was 6 % in Group 1 , 16 % in Group 2 , and 31 % in Group 3 .\
RESULTS	The fusion rate , as evaluated by plain radiograph , was 72 % in Group 1 , 87 % in Group 2 , and 91 % in Group 3 .\
CONCLUSIONS	All the fusion techniques used in the study could reduce pain and improve function in this selected group of patients with severe chronic low back pain .\
CONCLUSIONS	There was no obvious disadvantage in using the least demanding surgical technique of posterolateral fusion without internal fixation .\
\
###23174369\
OBJECTIVE	The effects of potent statins on oxidized lipoprotein biomarkers are not well defined .\
RESULTS	The VISION ( Value of oxIdant lipid lowering effect by Statin InterventiON in hypercholesterolemia ) Trial randomized patients with hypercholesterolemia to 12-week administration of pitavastatin 2mg/day ( n = 21 ) or atorvastatin 10mg/day ( n = 21 ) and a variety of lipoprotein oxidative biomarkers were measured .\
RESULTS	Between-group analysis did not reveal any differences except in the ratio of malondialdehyde ( MDA ) - LDL over apolipoprotein B-100 ( MDA-LDL/apoB ) in pitavastatin vs. atorvastatin group ( -13 % vs.-0 .7 % , p = 0.04 ) .\
RESULTS	Within-group changes from baseline to 12-week revealed significant increases in OxPL/apoB and reductions in small-dense LDL , MDA-LDL , and lipoprotein-associated phospholipase A ( 2 ) measured on circulating apoB particles ( Lp-PLA ( 2 ) / apoB ) in both groups and significant reductions in OxPL/apoAI in the atorvastatin group .\
CONCLUSIONS	The VISION study describes the first comparison on lipoprotein oxidation biomarkers between pitavastatin and atorvastatin and suggests diverse effects on lipoprotein oxidation markers in patients with hypercholesterolemia .\
\
###15217308\
OBJECTIVE	To estimate the costs , benefits and cost effectiveness , from the UK NHS perspective , of fluvastatin ( relative to no HMG-CoA reductase inhibitor [ statin ] ) for the secondary prevention of major adverse cardiac events following a successful first percutaneous coronary intervention ( PCI ) .\
METHODS	A cost-effectiveness analysis was undertaken using efficacy data from the Lescol Intervention Prevention Study ( LIPS ) .\
METHODS	LIPS was a randomised , double-blind , placebo-controlled trial undertaken in 77 centres ( predominantly in Europe ) .\
METHODS	Patients included in the trial had moderate hypercholesterolaemia and had successfully undergone their first PCI .\
METHODS	Fluvastatin ( Lescol ) 40 mg twice daily plus dietary counselling was given to the intervention group for up to 4 years ; the control group received dietary counselling only .\
METHODS	A Markov model was used to estimate the incremental costs per QALY gained over a 10-year period , with cost data drawn from the UK NHS ( 2002 values ) .\
METHODS	Monte Carlo simulations and multivariate analysis were used to assess uncertainty .\
METHODS	Costs were discounted at 6 % per annum , and health outcomes at 1.5 % per annum .\
RESULTS	On average , treatment with fluvastatin cost an additional pound 300 ( SD pound 303 ) [ euro 423 ; SD euro 428 ] per patient and resulted in an additional 0.092 ( SD 0.06 ) QALYs per patient over 10 years compared with controls .\
RESULTS	The incremental cost per QALY gained with fluvastatin versus the control group was pound 3207 ( SD pound 5,497 ) [ euro 4,527 ; SD euro 7,759 ] .\
RESULTS	Fluvastatin was dominant ( better outcomes and lower costs ) in 15.9 % of the simulations and was dominated in 2.9 % .\
RESULTS	The key determinants of cost effectiveness were : the effectiveness of fluvastatin in reducing acute myocardial infarction , subsequent PCI , coronary artery bypass graft and cardiac deaths ; the utility weight associated with a subsequent post-PCI state ; the cost of fluvastatin ; and the time horizon evaluated .\
CONCLUSIONS	Fluvastatin is the only statin which has proven effective in preventing major coronary adverse events in new PCI patients ; other statins lack this evidence .\
CONCLUSIONS	This Markov model , with its underlying assumptions and data , suggests that fluvastatin is a viable and economically efficient pharmaceutical ( relative to no statin ) to reduce heart disease in the UK when given routinely to all patients following PCI .\
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###16931989\
BACKGROUND	Several recent studies suggest that repetitive transcranial magnetic stimulation can temporarily reduce pain perception in neuropathic pain patients and in healthy adults using laboratory pain models .\
BACKGROUND	No studies have investigated the effects of prefrontal cortex stimulation using transcranial magnetic stimulation on postoperative pain .\
METHODS	Twenty gastric bypass surgery patients were randomly assigned to receive 20 min of either active or sham left prefrontal repetitive transcranial magnetic stimulation immediately after surgery .\
METHODS	Patient-controlled analgesia pump use was tracked , and patients also rated pain and mood twice per day using visual analog scales .\
RESULTS	Groups were similar at baseline in terms of body mass index , age , mood ratings , pain ratings , surgery duration , time under anesthesia , and surgical anesthesia methods .\
RESULTS	Significant effects were observed for surgery type ( open vs. laparoscopic ) and condition ( active vs. sham transcranial magnetic stimulation ) on the cumulative amount of patient-delivered morphine during the 44 h after surgery .\
RESULTS	Active prefrontal repetitive transcranial magnetic stimulation was associated with a 40 % reduction in total morphine use compared with sham during the 44 h after surgery .\
RESULTS	The effect seemed to be most prominent during the first 24 h after cortical stimulation delivery .\
RESULTS	No effects were observed for repetitive transcranial magnetic stimulation on mood ratings .\
CONCLUSIONS	A single session of postoperative prefrontal repetitive transcranial magnetic stimulation was associated with a reduction in patient-controlled analgesia pump use in gastric bypass surgery patients .\
CONCLUSIONS	This is important because the risks associated with postoperative morphine use are high , especially among obese patients who frequently have obstructive sleep apnea , right ventricular dysfunction , and pulmonary hypertension .\
CONCLUSIONS	These preliminary findings suggest a potential new noninvasive method for managing postoperative morphine use .\
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###11885176\
BACKGROUND	Because the life expectancy of individuals continues to increase , dentists providing dental implant treatment can expect to see an increasing number of patients with diabetes mellitus .\
BACKGROUND	Today , there are little data available concerning the clinical outcomes involving the use of implant treatment for patients with diabetes mellitus .\
BACKGROUND	There are three types of diabetes mellitus : Type 1 ( insulin dependent ) , Type 2 ( non-insulin dependent ) , and gestational .\
BACKGROUND	Because of possible complications from patients with diabetes mellitus , they are excluded from participation in most clinical studies of endosseous dental implant survival .\
METHODS	This study attempted to determine if Type 2 diabetes represents a significant risk factor to the long-term clinical performance of dental implants , using the comprehensive DICRG database .\
METHODS	Diabetes was a possible exclusion criterion ; however , the final decision on Type 2 patients was left to the dental implant team at the research center .\
METHODS	A total of 2,887 implants ( 663 patients ) were surgically placed , restored , and followed for a period of 36 months .\
METHODS	Of these , 2,632 ( 91 % ) implants were placed in non-diabetic patients and 255 ( 8.8 % ) in Type 2 patients .\
METHODS	Failures ( survival ) were compared using descriptive data .\
METHODS	Possible clustering was also studied .\
RESULTS	A model assuming independence showed that implants in Type 2 patients have significantly more failures ( P = 0.020 ) .\
RESULTS	However , if correlations among implants within the patient are considered , the significance level becomes marginal ( P = 0.046 ) .\
RESULTS	The experience of the surgeon did not produce a clinically significant improvement in implant survival .\
RESULTS	The use of chlorhexidine rinses following implant placement resulted in a slight improvement ( 2.5 % ) in survival in non-Type 2 patients and a greater improvement in Type 2 patients ( 9.1 % ) ; the use of preoperative antibiotics improved survival by 4.5 % in non-Type 2 patients and 10.5 % in Type 2 patients .\
RESULTS	The use of HA-coated implants improved survival by 13.2 % in Type 2 diabetics .\
CONCLUSIONS	Type 2 diabetic patients tend to have more failures than non-diabetic patients ; however , the influence was marginally significant .\
CONCLUSIONS	These findings need to be confirmed by other scientific clinical studies with a larger Type 2 diabetic sample size .\
\
###24625519\
OBJECTIVE	The use of peripherally inserted central venous catheters ( PICC lines ) has reduced the mortality and morbidity of premature newborns .\
OBJECTIVE	The usual sites of insertion are the veins in the upper arms but other locations are being used as well .\
METHODS	To examine whether using the axillary vein as a site of insertion of a PICC line affects the frequency of complications .\
METHODS	Our study has a clinical trial design .\
METHODS	A total of 62 neonates that had a PICC line inserted were recruited and randomly divided equally in two groups : in Group A ( mean birth weight , standard deviation ( s.d. ) = 1353 ( 142 ) g ) , the PICC line was inserted through the axillary vein , and in Group B ( birth weight = 1308 ( 112 ) g ) , the PICC line was inserted in other sites further from the axillary vein .\
METHODS	The outcomes measured were the total PICC line-related complications , the reason for removing the catheter , the number of total attempts until successful insertion and the mean duration of stay of the catheter .\
METHODS	The likelihood of having an adverse outcome was assessed with Mantel-Haenszel odds ratio ( OR ) .\
RESULTS	Premature neonates with axillary PICC lines were 12 times less likely to have line-related complications ( inflammation , blockage , edema , infection ) as compared with any other site of insertion ( OR = 95 % , confidence interval ( CI ) = 0.10 ( 0.01 to 0.8 ) ) and they were seven times more likely to have the PICC line removed because they achieved full enteral nutrition as compared with the other causes ( OR 95 % , confidence interval ( CI ) = 10.35 ( 4.88 to 21.96 ) ) .\
RESULTS	There was no statistical difference between the two groups in the number of attempts until successful PICC line insertion ( P = 0.667 ) and the mean duration of stay of the PICC line ( P = 0.97 ) .\
CONCLUSIONS	The use of the axillary vein as a site of insertion of a PICC line was correlated with significantly less complications in premature newborns as opposed to the other sites of insertion .\
\
###14600063\
OBJECTIVE	We evaluated female-condom use among women participating in an HIV/STD intervention designed to reduce unprotected sex and expand prevention strategies .\
METHODS	Women ( n = 360 ) were recruited from a family-planning clinic and were randomized into an 8 - or 4-session intervention group or a control group .\
METHODS	We conducted follow-up interviews at 1 , 6 , and 12 months .\
RESULTS	At 1 month , the odds ratios of first-time female-condom use were 9.49 ( 95 % confidence interval [ CI ] = 4.01 , 22.20 ) in the 8-session group and 4.39 ( 95 % CI = 1.84 , 10.49 ) in the 4-session group relative to controls .\
RESULTS	Repeated use ( n = 21 ) was predicted by perceived ability to use , by self and partner satisfaction , by dislike of male condoms , and by previous diaphragm use .\
CONCLUSIONS	Gender sensitive cognitive-behavioral interventions can influence women to try the female condom .\
CONCLUSIONS	To increase long-term use , interventions may need to include self-insertion practice and involvement of male partners .\
\
###19712983\
BACKGROUND	This study tested the hypothesis that statins may reduce left ventricular hypertrophy ( LVH ) in patients with hypertension and LVH .\
METHODS	A prospective randomised open-label study with blinded endpoints assessment was performed in 142 patients .\
METHODS	Inclusion criteria were hypertension , left ventricular ejection fraction 50 % and echocardiographic determined LVH , defined as a left ventricular mass index ( LVMI ) of 100 g/m ( 2 ) in women and 116 g/m ( 2 ) in males .\
METHODS	Patients were randomised between rosuvastatin 20mg once daily vs control .\
METHODS	For each patient an echocardiogram and blood samples were obtained .\
METHODS	These tests were repeated after 6 months .\
RESULTS	Baseline characteristics : mean age was 62 11year and 62 ( 44 % ) were male .\
RESULTS	In both groups , there was a non-significant reduction in LVMI : 118 22 to 111 19 g/m ( 2 ) in the control group and 118 21 to 114 22 in the rosuvastatin group ( p = 0.376 for the comparison between rosuvastatin and control after 6 months ) .\
RESULTS	After six months , LDL-cholesterol was reduced from 3.5 1.0 to 2.1 1.2 mmol/L ( 40 % reduction ) in the rosuvastatin group and remained unchanged in the control group ( 3.5 0.9 vs 3.6 0.9 mmol/L .\
RESULTS	Hs-CRP decreased more with rosuvastatin compared to control ( -38 % vs -15 % , p = 0.006 ) There was no significant reduction in NT-pro-BNP levels after 6 months .\
CONCLUSIONS	Rosuvastatin does not reduce LVH despite a large LDL reduction in patients with hypertension and LVH .\
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###12358234\
OBJECTIVE	The purpose of this research was to determine the impact of pretreatment Helicobacter pylori infection on gastric ulcer healing rates in patients receiving nonsteroidal anti-inflammatory drugs ( NSAIDs ) and antisecretory medications .\
METHODS	This was a pooled , prospective analysis of two identical double blind , multicenter , parallel group studies .\
METHODS	Six hundred ninety-two patients receiving NSAIDs and with endoscopy-documented gastric ulcers were enrolled from 90 North American sites in primary care and referral centers .\
METHODS	Patients were randomized to receive ranitidine ( 150 mg b.i.d. ) or lansoprazole ( 15 mg or 30 mg once daily ) for 8 wk .\
METHODS	Ulcer healing was assessed by endoscopy at 4 and 8 wk in an intent-to-treat population .\
METHODS	H. pylori status was determined at baseline by histology .\
RESULTS	Across all three treatment groups , gastric ulcers were more likely to heal and heal faster if the individual was infected with H. pylori .\
RESULTS	Healing rates at 8 wk were statistically significantly greater among H. pylori positive patients ( n = 181 ) than among negative patients ( n = 497 ) ( 70 % vs 61 % , respectively ; p < 0.05 ) , especially among those with large ulcers ( > 10 mm ) and in younger patients ( < 60 yr old ) .\
RESULTS	Simple healing rates ( regardless of H. pylori status ) were significantly better in the 15 - and 30-mg lansoprazole groups than in the ranitidine group after 4 wk ( 46 % , 54 % , and 32 % , respectively ; p < or = 0.01 ) and 8 wk ( 66 % , 74 % , and 50 % , respectively ; p < 0.001 ) .\
CONCLUSIONS	In patients receiving NSAIDs , gastric ulcer healing with an antisecretory agent is significantly enhanced in the presence of H. pylori infection .\
\
###19474112\
BACKGROUND	To compare the incidence and timing of bone fractures in postmenopausal women treated with 5 years of adjuvant tamoxifen or letrozole for endocrine-responsive early breast cancer in the Breast International Group ( BIG ) 1-98 trial .\
METHODS	We evaluated 4895 patients allocated to 5 years of letrozole or tamoxifen in the BIG 1-98 trial who received at least some study medication ( median follow-up 60.3 months ) .\
METHODS	Bone fracture information ( grade , cause , site ) was collected every 6 months during trial treatment .\
RESULTS	The incidence of bone fractures was higher among patients treated with letrozole [ 228 of 2448 women ( 9.3 % ) ] versus tamoxifen [ 160 of 2447 women ( 6.5 % ) ] .\
RESULTS	The wrist was the most common site of fracture in both treatment groups .\
RESULTS	Statistically significant risk factors for bone fractures during treatment included age , smoking history , osteoporosis at baseline , previous bone fracture , and previous hormone replacement therapy .\
CONCLUSIONS	Consistent with other trials comparing aromatase inhibitors to tamoxifen , letrozole was associated with an increase in bone fractures .\
CONCLUSIONS	Benefits of superior disease control associated with letrozole and lower incidence of fracture with tamoxifen should be considered with the risk profile for individual patients .\
\
###10548673\
OBJECTIVE	Of all stroke survivors , 30 % to 66 % are unable to use their affected arm in performing activities of daily living .\
OBJECTIVE	Although forced use therapy appears to improve arm function in chronic stroke patients , there is no conclusive evidence .\
OBJECTIVE	This study evaluates the effectiveness of forced use therapy .\
METHODS	In an observer-blinded randomized clinical trial , 66 chronic stroke patients were allocated to either forced use therapy ( immobilization of the unaffected arm combined with intensive training ) or a reference therapy of equally intensive bimanual training , based on Neuro-Developmental Treatment , for a period of 2 weeks .\
METHODS	Outcomes were evaluated on the basis of the Rehabilitation Activities Profile ( activities ) , the Action Research Arm ( ARA ) test ( dexterity ) , the upper extremity section of the Fugl-Meyer Assessment scale , the Motor Activity Log ( MAL ) , and a Problem Score .\
METHODS	The minimal clinically important difference ( MCID ) was determined at the onset of the study .\
RESULTS	One week after the last treatment session , a significant difference in effectiveness in favor of the forced use group compared with the bimanual group ( corrected for baseline differences ) was found for the ARA score ( 3.0 points ; 95 % CI , 1.3 to 4.8 ; MCID , 5.7 points ) and the MAL amount of use score ( 0.52 points ; 95 % CI , 0.11 to 0.93 ; MCID , 0.50 ) .\
RESULTS	The other parameters revealed no significant differential effects .\
RESULTS	One-year follow-up effects were observed only for the ARA .\
RESULTS	The differences in treatment effect for the ARA and the MAL amount of use scores were clinically relevant for patients with sensory disorders and hemineglect , respectively .\
CONCLUSIONS	The present study showed a small but lasting effect of forced use therapy on the dexterity of the affected arm ( ARA ) and a temporary clinically relevant effect on the amount of use of the affected arm during activities of daily living ( MAL amount of use ) .\
CONCLUSIONS	The effect of forced use therapy was clinically relevant in the subgroups of patients with sensory disorders and hemineglect , respectively .\
\
###23945170\
OBJECTIVE	Consumption of fish and marine n-3 polyunsaturated fatty acids ( PUFA ) may be associated with a lower risk of atrial fibrillation ( AF ) , but results have been inconsistent .\
OBJECTIVE	The aim was to investigate this further by measurements of marine n-3 PUFA in adipose tissue .\
METHODS	Cohort study .\
METHODS	A total of 57 053 Danish participants 50-64 years of age were enrolled into the Diet , Cancer and Health Cohort Study .\
METHODS	A randomly drawn subcohort of 3440 participants with available data from baseline adipose tissue biopsies .\
METHODS	Exposure was the adipose tissue content of marine n-3 PUFA , which reflects the endogenous exposure and is also an objective marker of the long-term dietary intake .\
METHODS	Incident AF during follow-up .\
RESULTS	179 cases of AF occurred over 13.6 years .\
RESULTS	Multivariate , sex-stratified Cox proportional hazards regression analyses using cubic splines showed a monotonic , negative , dose-response trend , but not statistically significant association , between total marine n-3 PUFA in adipose tissue and incident AF .\
RESULTS	A similar trend towards a lower risk of AF was seen in the second ( HR 0.87 , 95 % CI 0.60 to 1.24 ) and third tertiles ( HR 0.77 , 95 % CI 0.53 to 1.10 ) of marine n-3 PUFA compared with the lowest tertile .\
RESULTS	Similar trends , but also not statistically significant , were found separately for eicosapentaenoic , docosahexaenoic and docosapentaenoic acids .\
CONCLUSIONS	There was no statistically significant association between the content of marine n-3 PUFA in adipose tissue and the development of AF ; however , data showed a monotonic , negative dose-response trend suggestive of a negative association .\
\
###9972902\
BACKGROUND	The aim of our study was to evaluate the efficacy of myocardial protection during coronary artery bypass grafting ( CABG ) in cold blood intermittent ( CBIC ) and warm continuous blood cardioplegia ( WCBC ) .\
BACKGROUND	To assess myocardial necrosis , Troponin T , a structural protein belonging to the troponin complex , was measured .\
BACKGROUND	Troponin T is released in the blood stream 4 hours after myocardial damage , and it does not cross-react with the isomeric form of the skeletal muscle .\
METHODS	Our study involved 20 consecutive patients , scheduled for isolated CABG .\
METHODS	They were divided into two groups : the first group ( 10 patients ; 8 m , 2 f ) underwent surgery with the use of CBIC , the second group ( 10 patients ; 9 m , 1 f ) with WCBC .\
METHODS	The serum levels of cardiac Troponin T ( cTn-T ) were all < 0.2 microg/l before operation .\
RESULTS	In the CBIC the mean cTn-T peaked on the 1st day after CABG , in the WCBC group the first peak occurred in the 2nd hour after arrival in the intensive care unit , and the second peak occurred on the 4th day postoperatively .\
RESULTS	The mean serum cTn-T was lower in the WCBC vs CBIC group from the 1st to the 5th day postoperatively , with a statistical difference on the 1st day ( p < 0.05 ) .\
RESULTS	In the CBIC group either the cTn-T peak values ( r = 0.77 ; p < 0.02 ) or area under the concentration curve of cTn-T release ( r = 0.85 ; p < 0.004 ) , were directly correlated with the aortic cross-clamping time .\
RESULTS	This was not demonstrated in the WCBC .\
RESULTS	CPK and CK-MB peaked in both groups 6 hours after arrival in the intensive care unit and on the 1st day postoperatively , with higher values at 6 hours in the WCBC group ( p < 0.05 ) .\
RESULTS	The CK-MB/CPK ratio was significantly lower in the WCBC group at the six hours ( p < 0.05 ) .\
CONCLUSIONS	The results of this preliminary study suggest that fewer necrosis markers are released during CABG in the WCBC group ; in the CBIC group the release of cTn-T whether measured by peak serum level or by area under the curve , shows a statistically significant correlation with cross-clamping time .\
CONCLUSIONS	Warm blood cardioplegia is safe and supplies adequate myocardial protection during CABG ; the more prolonged cross-clamping is , the more myocardial protection is afforded by WCBC .\
\
###8021483\
OBJECTIVE	To assess the individual and combined effects of exercise and weight loss on the cardiovascular risk factors and cardiac left ventricular structure and function in overweight individuals .\
METHODS	A randomized , parallel-group , crossover study design was adopted .\
METHODS	The following treatments were employed : exercise three times a week at 70 % maximum work capacity for 30 min ; dietary modification to achieve weight loss involving 4200 kj/day dietary restriction ; and a combination of both exercise and dietary modification weight-loss programmes .\
METHODS	Each subject was randomly assigned to one group only and was studied after a 12-week treatment and 12-week control period , performed in a random order .\
METHODS	Thirty subjects entered the trial , 23 completing both treatment and control phases .\
RESULTS	Body weight remained unchanged with exercise alone and fell significantly both with weight loss and with the combination .\
RESULTS	The corresponding effects on blood pressure were also significant .\
RESULTS	Exercising groups also showed a significant increase in maximal oxygen consumption and a reduction in heart rate .\
RESULTS	Serum cholesterol and triglycerides fell significantly only after the combination , whereas high-density lipoprotein-cholesterol increased with exercise , decreased with weight loss and did not change with the combination .\
RESULTS	Interventricular septum and posterior wall thickness measurements remained unchanged after 12 weeks ' treatment in all groups .\
RESULTS	No significant changes occurred in left ventricular internal diastolic diameter , wall thickness : radius ratio or the heart rate corrected ratio of peak early diastolic filling velocity : peak late diastolic filling velocity .\
RESULTS	Left ventricular mass and mass indexed to body surface area were not changed in any group .\
CONCLUSIONS	The results indicate that the effects of exercise and weight reduction on blood pressure are additive , although a positive interaction may exist with respect to lipids .\
CONCLUSIONS	Despite lowering blood pressure , exercise and weight loss had no effect on cardiac left ventricular structure or function in these overweight individuals .\
\
###16774980\
OBJECTIVE	The risk of stroke is greater among women with atrial fibrillation ( AF ) than men .\
OBJECTIVE	Warfarin protects against stroke , but treatment-related bleeding occurs more often in women than in men .\
RESULTS	SPORTIF III ( open label , n = 3410 ) and V ( double-blind , n = 3922 ) included 2257 women with AF and one or more stroke risk factors randomized to warfarin [ target international normalized ratio ( INR ) 2.0-3 .0 ] or ximelagatran ( 36 mg twice daily ) .\
RESULTS	Primary outcomes were all stroke ( ischaemic/haemorrhagic ) and systemic embolic event .\
RESULTS	Women were older , on average , than men , 73.4 + / -8.0 vs. 69.8 + / -9.0 years ( P < 0.0001 ) .\
RESULTS	More women were > 75-years old and women had more risk factors than men had ( P < 0.0001 ) .\
RESULTS	The INR on warfarin ( mean 2.5 + / -0.7 ) was within target range for 67 % of follow-up regardless of gender .\
RESULTS	Women more often developed primary events [ 2.08 % / year , 95 % confidence interval ( CI ) 1.60-2 .56 % / year vs. 1.44 % / year , 95 % CI 1.18-1 .71 % / year in men ; P = 0.016 ) .\
RESULTS	Major bleeding rates were similar ( P = 0.766 ) but women experienced more overall ( major/minor ) bleeding ( P < 0.001 ) .\
RESULTS	Warfarin was associated with more overall bleeding in both genders and more major bleeding in women than in men ( P = 0.001 ) .\
CONCLUSIONS	When compared with men with AF , women in these studies were older and had more stroke risk factors .\
CONCLUSIONS	Women were more prone to anticoagulant-related bleeding ; the higher rate of thrombo-embolism among women was related to more frequent interruption of anticoagulant therapy .\
\
###10479199\
BACKGROUND	Phylloquinone , found in dark-green vegetables and certain plant oils , is the primary dietary source of the fat-soluble vitamin K. Limited data suggest that the relative bioavailability of phylloquinone from vegetables is lower than that from a supplement .\
BACKGROUND	This finding is relevant to the maintenance of optimal vitamin K status .\
OBJECTIVE	The objective of this study was to compare , in younger and older adults , the relative bioavailability of phylloquinone from a vegetable with that of a fortified oil .\
METHODS	In a crossover design with three 15-d residency periods in a metabolic unit , younger and older men and women ( n = 36 ) consumed a mixed diet containing 100 microg phylloquinone/d .\
METHODS	During 2 residency periods , the mixed diet was supplemented for 5 d with either broccoli ( 377 microg phylloquinone/d ; broccoli diet ) or phylloquinone-fortified oil ( 417 microg/d ; oil diet ) .\
METHODS	The relative bioavailability of phylloquinone was defined by the difference in plasma phylloquinone , percentage serum undercarboxylated osteocalcin ( % ucOC ) , and urinary gamma-carboxyglutamic acid in response to 5 d of supplementation .\
RESULTS	For both younger and older adults , plasma phylloquinone concentrations were higher ( P < 0.001 ) and % ucOC values were lower ( P = 0.001 ) after the broccoli and oil diets than after the mixed diet only .\
RESULTS	Overall , the response to broccoli supplementation was not significantly different from the response to the fortified oil in either age group .\
RESULTS	Urinary gamma-carboxyglutamic acid did not change in response to supplementation .\
CONCLUSIONS	There was no significant difference in the relative bioavailability of phylloquinone , as evidenced by the lack of a significant difference in plasma phylloquinone and % ucOC between the 2 groups after either the broccoli or oil diets for younger and older adults .\
\
###22839514\
OBJECTIVE	To determine advantages of therapy of functional class ( FC ) I-II chronic heart failure ( CHF ) with preserved left ventricular ( LV ) ejection fraction in patients with hypertensive disease ( HD ) with metoprolol succinate or quinapril and to assess their effect on regulatory-adaptive status .\
METHODS	Two hundred patients with I-II FC CHF and LVEF > 50 % at the background of stage I-II hypertensive disease participated in this study .\
METHODS	They were randomized into 2 groups .\
METHODS	Group I comprised 104 patients ( mean age 52.8 +1.9 years ) who were prescribed metoprolol succinate 87.7 + / -7.6 mg/day .\
METHODS	Patients of group 2 ( n = 96 , mean age 55.0 + / -1.4 years ) were prescribed quinapril 21.0 +55 mg/day .\
METHODS	Examination at baseline and after 6 months of therapy included 6 min walk test , treadmillometry with assessment of maximal oxygen consumptiion ( VO2max ) , echocardiography , 24 hour blood pressure monitoring , measurement of N-terminal precursor of brain natriuretic peptide ( NT-proBNP ) ; test of cardio-respiratory synchronism was used for objective qualitative determination of the state of the , renin-angiotensin system .\
RESULTS	Both drugs improved parameters of LV diastolic function , but only quinapril effectively changed LV structural geometric parameters and systolic function .\
RESULTS	Only treatment with quinapril was associated with improvement of RAS , elevation of tolerance to physical effort , and increased VO2max .\
RESULTS	Quinapril more substantially lowered level of NT-proBNP .\
CONCLUSIONS	Quinapril has an advantage over metoprolol succinate in therapy of patients with FC I-II CHF and preserved LF EF at the background of stage I-II HD .\
\
###21355967\
OBJECTIVE	The aim of this study was to compare the efficacy and safety of once-daily human glucagon-like peptide-1 analogue liraglutide with dipeptidyl peptidase-4 inhibitor sitagliptin , each added to metformin , over 52 weeks in individuals with type 2 diabetes .\
METHODS	In an open-label , parallel-group trial , metformin-treated participants were randomised to liraglutide 1.2 mg/day ( n = 225 ) , liraglutide 1.8 mg/day ( n = 221 ) or sitagliptin 100 mg/day ( n = 219 ) for 26 weeks ( main phase ) .\
METHODS	Participants continued the same treatment in a 26-week extension .\
RESULTS	Liraglutide ( 1.2 or 1.8 mg ) was superior to sitagliptin for reducing HbA ( 1c ) from baseline ( 8.4-8 .5 % ) to 52 weeks : -1.29 % and -1.51 % vs. -0.88 % respectively .\
RESULTS	Estimated mean treatment differences between liraglutide and sitagliptin were as follows : -0.40 % ( 95 % confidence interval -0.59 to -0.22 ) for 1.2 mg and -0.63 % ( -0.81 to -0.44 ) for 1.8 mg ( both p < 0.0001 ) .\
RESULTS	Weight loss was greater with liraglutide 1.2 mg ( -2.78 kg ) and 1.8 mg ( -3.68 kg ) than sitagliptin ( -1.16 kg ) ( both p < 0.0001 ) .\
RESULTS	Diabetes Treatment Satisfaction Questionnaire scores increased significantly more with liraglutide 1.8 mg than with sitagliptin ( p = 0.03 ) .\
RESULTS	Proportions of participants reporting adverse events were generally comparable ; minor hypoglycaemia was 8.1 % , 8.3 % and 6.4 % for liraglutide 1.2 mg , 1.8 mg and sitagliptin respectively .\
RESULTS	Gastrointestinal side effects , mainly nausea , initially occurred more frequently with liraglutide , but declined after several weeks .\
CONCLUSIONS	Liraglutide provides greater sustained glycaemic control and body weight reduction over 52 weeks .\
CONCLUSIONS	Treatment satisfaction was significantly greater with 1.8 mg liraglutide , similar to 26-week results .\
CONCLUSIONS	The safety profiles of liraglutide and sitagliptin are consistent with previous reports .\
\
###14616318\
BACKGROUND	Mivacurium is hydrolyzed by plasma cholinesterase ( pChe ) .\
BACKGROUND	The purpose of this study was to evaluate the pharmacodynamics and the pharmacokinetics of the three isomers of mivacurium in patients phenotypically heterozygous for the usual and the atypical pChe variant ( UA ) .\
METHODS	Thirty-two patients were included in a dose-response study , in which the patients received one of four doses of mivacurium .\
METHODS	An additional bolus dose of mivacurium , to a total of 0.1 mg kg-1 , was given followed by a continuous infusion adjusted to maintain 91-99 % neuromuscular block .\
METHODS	The times to different levels of recovery following the infusion were measured using mechanomyography and train-of-four ( TOF ) nerve stimulation .\
METHODS	Twelve of the patients with an estimated duration of anaesthesia of more than 90 min were ( randomly ) selected for the pharmacokinetic part of the study .\
METHODS	Venous samples were taken for determination of the three isomers of mivacurium .\
METHODS	These results were compared with results from a previous study in phenotypically normal patients ( UU ) .\
RESULTS	The estimated ED50 and ED95 were 24 and 69 microg kg-1 , respectively .\
RESULTS	The median ( range ) infusion rate was 3.7 microg kg-1 min-1 ( 1.2-2 .9 ) and the time to a TOF ratio of 0.7 was 29.8 min ( 16.1-44 .8 ) .\
RESULTS	The median clearances of the cis-cis , cis-trans and trans-trans isomers were 3.7 , 29 and 28 ml kg-1 min-1 , respectively .\
RESULTS	The elimination half-lives of the isomers were 45 , 6.7 and 6.3 min , respectively .\
CONCLUSIONS	In patients heterozygous for the usual and the atypical variant ( UA ) , the potency of mivacurium is higher , the infusion requirements lower and the rate of spontaneous recovery prolonged , compared with phenotypically normal patients .\
CONCLUSIONS	The clearances of the active isomers are significantly lower and the elimination half-lives longer in heterozygous patients than in phenotypically normal patients ( UU ) .\
CONCLUSIONS	The pharmacokinetics of the inactive cis-cis isomer was not affected .\
\
###17084844\
OBJECTIVE	Oral estrogens reduce asymmetric dimethylarginine ( ADMA ) , an endogenous inhibitor of nitric oxide synthase , and an independent risk factor for cardiovascular disease .\
OBJECTIVE	This study was conducted to compare the effect on ADMA between intranasal and oral 17beta-estradiol ( E2 ) combined with norethisterone ( acetate ) ( NET ( A ) ) administration in postmenopausal women .\
METHODS	In a two-center , randomized , double-blind , comparative study 90 healthy postmenopausal women ( age 56.6 + / -4.7 years ) received daily continuous combined intranasal E2/NET 175 microg/275 microg ( n = 47 ) or oral E2/NETA 1 mg/0 .5 mg ( n = 43 ) for one year .\
METHODS	At baseline , week 12 and 52 , plasma concentrations of ADMA , arginine and symmetric dimethylarginine ( SDMA ) were measured by high-performance liquid chromatography .\
RESULTS	Oral E2/NETA reduced ADMA concentrations ( -7.4 % ; 95 % confidence interval ( CI ) -10.4 to -4.4 % ) , while intranasal E2/NET had no effect ( -0.8 % ; 95 % CI -3.7 to 2.1 % ) after 52 weeks .\
RESULTS	In both groups , arginine was transiently decreased compared to baseline at week 12 ( intranasal : -6.1 % ; 95 % CI -9.1 to -3.0 % ; oral : -6.5 % ; 95 % CI -10.9 to -2.1 % ) .\
RESULTS	Only oral E2/NETA reduced SDMA concentrations .\
CONCLUSIONS	Oral administration of E2/NETA reduced ADMA and SDMA concentrations , whereas intranasal administration did not .\
CONCLUSIONS	Both treatments transiently reduced arginine .\
CONCLUSIONS	The decrease in ADMA by oral estrogens could be a key phenomenon in the modulation of nitric oxide synthesis by postmenopausal hormone therapy .\
\
###17634183\
OBJECTIVE	To compare the effect of inhaled budesonide given daily or as-needed on mild persistent childhood asthma .\
OBJECTIVE	Patients , design and\
METHODS	176 children aged 5-10 years with newly detected asthma were randomly assigned to three treatment groups : ( 1 ) continuous budesonide ( 400 microg twice daily for 1 month , 200 microg twice daily for months 2-6 , 100 microg twice daily for months 7-18 ) ; ( 2 ) budesonide , identical treatment to group 1 during months 1-6 , then budesonide for exacerbations as needed for months 7-18 ; and ( 3 ) disodium cromoglycate ( DSCG ) 10 mg three times daily for months 1-18 .\
METHODS	Exacerbations were treated with budesonide 400 microg twice daily for 2 weeks .\
METHODS	Lung function , the number of exacerbations and growth .\
RESULTS	Compared with DSCG the initial regular budesonide treatment resulted in a significantly improved lung function , fewer exacerbations and a small but significant decline in growth velocity .\
RESULTS	After 18 months , however , the lung function improvements did not differ between the groups .\
RESULTS	During months 7-18 , patients receiving continuous budesonide treatment had significantly fewer exacerbations ( mean 0.97 ) , compared with 1.69 in group 2 and 1.58 in group 3 .\
RESULTS	The number of asthma-free days did not differ between regular and intermittent budesonide treatment .\
RESULTS	Growth velocity was normalised during continuous low-dose budesonide and budesonide therapy given as needed .\
RESULTS	The latter was associated with catch-up growth .\
CONCLUSIONS	Regular use of budesonide afforded better asthma control but had a more systemic effect than did use of budesonide as needed .\
CONCLUSIONS	The dose of ICS could be reduced as soon as asthma is controlled .\
CONCLUSIONS	Some children do not seem to need continuous ICS treatment .\
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###22947847\
OBJECTIVE	The purpose of this study was to determine if vital tooth whitening affects oral health-related quality of life ( OHRQOL ) in adults age 50 years and older , and if tooth whitening causes increased participation in social activities .\
METHODS	Using a 2 group , single blind , randomized , pre-test , multiple post-test design , 62 participants were enrolled .\
METHODS	The experimental group used a whitening product twice daily for 3 weeks .\
METHODS	The control group used no whitening products .\
METHODS	The Oral Health Impact Profile ( OHIP ) served as the pre - and post-test measure .\
METHODS	The OHIP measures OHRQOL on 7 subscales : functional factors , psychological disabilities , psychological discomforts , physical disabilities , social disabilities , handicaps and physical pain .\
METHODS	Additional questions measured the subjects ' social activities at baseline , 3 weeks and 3 months .\
METHODS	Data from 53 participants , who completed the study , were analyzed using paired t-tests and ANOVA at p = 0.05 .\
RESULTS	Statistical significance was observed for the OHIP physical pain subscale ( p = 0.0029 ) and the handicap subscale ( p = 0.05 ) .\
RESULTS	Pre - to post-test means of the physical pain subscale increased in the experimental group ( 4.84 to 7.10 ) , suggesting a lower OHRQOL , most likely related to tooth sensitivity experienced by the experimental group .\
RESULTS	Means from pre - to post-test of the handicap subscale ( 1.96 to 1.19 ) reveal that the experimental group reported an improved OHRQOL and felt they were more willing to work .\
RESULTS	Repeated measures ANOVA and Tukey 's post-hoc tests revealed that the experimental group reported significantly less ( p = 0.04 ) social activities at the 3 month post-test ( 3.92 to 3.45 ) .\
RESULTS	No statistically significant between-group differences were observed in the overall OHIP score for functional factors , psychological disabilities , psychological discomforts , physical disabilities and social disabilities .\
CONCLUSIONS	Results indicate that vital tooth whitening does not improve overall OHRQOL in older adults .\
\
###19926194\
OBJECTIVE	We hypothesized that a unique tock and voice metronome could prevent both suboptimal chest compression rates and hyperventilation .\
METHODS	A prospective , randomized , parallel design study involving 34 pairs of paid firefighter/emergency medical technicians ( EMTs ) performing two-rescuer CPR using a Laerdal SkillReporter Resusci Anne manikin with and without metronome guidance was performed .\
METHODS	Each CPR session consisted of 2 min of 30:2 CPR with an unsecured airway , then 4 min of CPR with a secured airway ( continuous compressions at 100 min ( -1 ) with 8-10 ventilations/min ) , repeated after the rescuers switched roles .\
METHODS	The metronome provided `` tock '' prompts for compressions , transition prompts between compressions and ventilations , and a spoken `` ventilate '' prompt .\
RESULTS	During CPR with a bag/valve/mask the target compression rate of 90-110 min ( -1 ) was achieved in 5/34 CPR sessions ( 15 % ) for the control group and 34/34 sessions ( 100 % ) for the metronome group ( p < 0.001 ) .\
RESULTS	An excessive ventilation rate was not observed in either the metronome or control group during CPR with a bag/valve/mask .\
RESULTS	During CPR with a bag/endotracheal tube , the target of both a compression rate of 90-110 min ( -1 ) and a ventilation rate of 8-11 min ( -1 ) was achieved in 3/34 CPR sessions ( 9 % ) for the control group and 33/34 sessions ( 97 % ) for the metronome group ( p < 0.001 ) .\
RESULTS	Metronome use with the secured airway scenario significantly decreased the incidence of over-ventilation ( 11/34 EMT pairs vs. 0/34 EMT pairs ; p < 0.001 ) .\
CONCLUSIONS	A unique combination tock and voice prompting metronome was effective at directing correct chest compression and ventilation rates both before and after intubation .\
\
###22884767\
BACKGROUND	Exenatide once weekly ( QW ) is an extended-release formulation of exenatide , a glucagon-like peptide-1 receptor agonist that reportedly improves glycemic control in patients with type 2 diabetes .\
OBJECTIVE	The goal of this study was to test the hypothesis that exenatide QW is noninferior to insulin glargine , as measured by change in glycosylated hemoglobin ( HbA ( 1c ) ) from baseline to end point ( week 26 [ primary end point ] ) in Japanese patients with type 2 diabetes who have inadequate glycemic control with oral antidiabetes drugs .\
METHODS	In this open-label , parallel-group , multicenter , noninferiority registration study , patients were randomized ( 1:1 ) to add exenatide QW ( 2 mg ) or once-daily insulin glargine ( starting dose , 4 U ) to their current oral antidiabetes drug treatment .\
METHODS	The primary analysis was change in HbA ( 1c ) from baseline to end point , evaluated by using a last-observation-carried-forward ANCOVA model , with a predefined noninferiority margin of 0.4 % .\
METHODS	Secondary analyses ( a priori ) included analysis of superiority for between-group comparisons of change in weight and the proportion of patients reaching HbA ( 1c ) target levels of 7.0 % or 6.5 % .\
RESULTS	The baseline characteristics of the exenatide QW ( 215 patients ) and insulin glargine ( 212 patients ) treatment groups were similar : mean ( SD ) age , 57 ( 10 ) years and 56 ( 11 ) years , respectively ; 66.0 % and 69.8 % male ; mean HbA ( 1c ) , 8.5 % ( 0.82 % ) and 8.5 % ( 0.79 % ) ; and mean weight , 69.9 ( 13.2 ) kg and 71.0 ( 13.9 ) kg .\
RESULTS	Exenatide QW was statistically noninferior to insulin glargine for the change in HbA ( 1c ) from baseline to end point ( least squares mean difference , -0.43 % [ 95 % CI , -0.59 to -0.26 ] ; P < 0.001 ) , with the 95 % CI upper limit less than the predefined noninferiority margin ( 0.4 % ) .\
RESULTS	A significantly greater proportion of patients receiving exenatide QW compared with insulin glargine achieved HbA ( 1c ) target levels of 7.0 % ( 89 of 211 [ 42.2 % ] vs 44 of 210 [ 21.0 % ] ) or 6.5 % ( 44 of 214 [ 20.6 % ] vs 9 of 212 [ 4.2 % ] ) at end point ( P < 0.001 for both ) .\
RESULTS	Patient weight was reduced with exenatide QW compared with insulin glargine at end point ( least squares mean difference , -2.01 kg [ 95 % CI , -2.46 to -1.56 ] ; P < 0.001 ) .\
RESULTS	Exenatide QW was well tolerated , with a lower risk of hypoglycemia compared with insulin glargine but a higher incidence of injection-site induration .\
CONCLUSIONS	Exenatide QW was statistically noninferior to insulin glargine for the change in HbA ( 1c ) from baseline to end point ; these results suggest that exenatide QW may provide an effective alternative treatment for Japanese patients who require additional therapy to control their diabetes .\
CONCLUSIONS	ClinicalTrials.gov identifier : NCT00935532 .\
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###22606044\
OBJECTIVE	To evaluate the efficacy and safety of donepezil plus natural hirudin in patients with mild-to-moderate Alzheimer 's Disease .\
METHODS	In the 20-week , randomized , open-label and controlled study , 84 patients received either donepezil ( 5 mg/day for the first 4 weeks and 10 mg/day thereafter ) or donepezil plus natural hirudin ( 3 g/day ) treatment .\
METHODS	Efficacy was reflected by the change of the total scores of Alzheimer 's Disease Assessment Scale cognitive subscale ( ADAS-Cog ) , Activities of Daily Life ( ADL ) and Neuropsychiatric Inventory ( NPI ) .\
RESULTS	The patients with the donepezil plus natural hirudin treatment showed more significant improvement in the daily activities and the decline of the cognition than those with donepezil treatment .\
RESULTS	Significant difference was present in the groups since the 8th week .\
RESULTS	No group difference was found in the NPI change .\
RESULTS	However , within the hirudin treatment group , more powerful efficacy including NPI assessment was found in the patients with vascular risk factors ( VRF ) as comparing to with those without VRF .\
RESULTS	The combination of donepezil and natural hirudin was well tolerated .\
RESULTS	The dropout rate was greater in the donepezil and natural hirudin ( 50 % ) treatment group than in the donepezil ( 39 % ) treatment group .\
RESULTS	Similar result was found in the incidence of adverse events ( 23.8 % vs 19.0 % ) , but there was no statistical difference between the two groups .\
RESULTS	Adverse events were the most common reason for the dropout .\
RESULTS	Although hemorrhage and hypersensitiveness were more common in donepezil plus Maixuekang treatment ( 11.9 % and 7.1 % ) group than in donepezil treatment ( 2.4 % and 2.4 % ) group , no significant difference was present between the two groups .\
RESULTS	Economic problem was another important reason for the patients ' withdrawal .\
CONCLUSIONS	Compared with the donepezil treatment in the patients with mild-to-moderate AD , our results suggest that donepezil combined with natural hirudin may improve the treatment effects in the ADL , BPSD and cognition of the patients .\
CONCLUSIONS	Furthermore , this joint treatment is safe .\
\
###24080992\
BACKGROUND	RTOG 0518 evaluated the potential benefit of zoledronic acid therapy in preventing bone fractures for patients with high grade and/or locally advanced , non-metastatic prostate adenocarcinoma receiving luteinizing hormone-releasing hormone ( LHRH ) agonist and radiotherapy ( RT ) .\
METHODS	Eligible patients with T-scores of the hip ( < -1.0 , but > -2.5 vs > -1.0 ) and negative bone scans were prospectively randomized to either zoledronic acid , 4mg , concurrently with the start of RT and then every six months for a total of 6 infusions ( Arm 1 ) or observation ( Arm 2 ) .\
METHODS	Vitamin D and calcium supplements were given to all patients .\
METHODS	Secondary objectives included quality of life ( QOL ) and bone mineral density ( BMD ) changes over a period of three years .\
RESULTS	Of 109 patients accrued before early closure , 96 were eligible .\
RESULTS	Median follow-up was 36.3 months for Arm 1 and 34.8 months for Arm 2 .\
RESULTS	Only two patients experienced a bone fracture ( one in each arm ) resulting in no difference in freedom from any bone fracture ( P = 0.95 ) , nor in QOL .\
RESULTS	BMD percent changes from baseline to 36 months were statistically improved with the use of zoledronic acid compared to observation for the lumbar spine ( 6 % vs -5 % , P < 0.0001 ) , left total hip ( 1 % vs -8 % , P = 0.0002 ) , and left femoral neck ( 3 % vs -8 % , P = 0.0007 ) .\
CONCLUSIONS	For patients with advanced , non-metastatic prostate cancer receiving LHRH agonist and RT , the use of zoledronic acid was associated with statistically improved BMD percent changes .\
CONCLUSIONS	The small number of accrued patients resulted in decreased statistical power to detect any differences in the incidence of bone fractures or QOL .\
\
###21054464\
OBJECTIVE	Genetic polymorphism of interleukin ( IL ) -1 and IL-1 receptor antagonist ( IL-1r ) are associated with efficacy of acid suppression , whereas cytochrome P ( CYP ) 2C19 polymorphism influences the metabolism of proton pump inhibitor family .\
OBJECTIVE	Thus , CYP2C19 and IL-1 polymorphisms may affect the efficacy of H. pylori eradication therapy .\
OBJECTIVE	We compared the efficacies of omeprazole and rabeprazole on eradication of H. pylori in relation to CYP2C19 , IL-1B and IL-1RN genotypes in Chinese people .\
METHODS	Two hundred and forty Chinese with peptic ulcer disease were randomly assigned to the following regimens : amoxicillin and clarithromycin together with omeprazole ( OAC ) or rabeprazole ( RAC ) .\
METHODS	CYP2C19 * 2 and * 3 , IL1B-511 , IL1B-31 , IL1B + 3954 and intron 2 of the IL-1RN genotypes were analyzed by polymerase chain reaction-restriction fragment length polymorphism .\
RESULTS	The intention-to-treat-based cure rate of the OAC regimen was significantly lower than that of the RAC regimen in the CYP2C19 wild-type homozygotes ( P = 0014 ) .\
RESULTS	No significant differences in the cure rates were observed among the IL-1RN and the IL-1B genotype groups .\
CONCLUSIONS	The rabeprazole-based triple regimen was better than the omeprazole in Chinese patients with the CYP2C19 extensive metabolizer genotype .\
CONCLUSIONS	The effectiveness of the PPI/AC regimen is unrelated to IL-1B and IL1-RN genetic polymorphism .\
\
###16769295\
OBJECTIVE	To assess the efficacy of lamotrigine or lithium in preventing mood recurrence ( i.e. , a new mood episode ) in bipolar disorder .\
METHODS	Data from bipolar I patients with relapses ( i.e. , mood episodes having the same polarity as the index episode within 90 or 180 days of randomization ) were excluded from post hoc efficacy analyses of two 18-month , placebo-controlled maintenance trials of lamotrigine and lithium .\
RESULTS	Both lamotrigine and lithium were more effective than placebo in delaying the time to intervention for any mood episode ( depression , mania , hypomania , or mixed ) when relapses that occurred in the first 90 days were excluded from the analyses ( p = .002 , lamotrigine vs. placebo ; p = .010 , lithium vs. placebo ) .\
RESULTS	Results were similar when patients with mood episodes within 180 days of randomization were excluded .\
CONCLUSIONS	Both lamotrigine and lithium maintenance therapy protected against mood episode recurrence in bipolar I disorder .\
\
###9106920\
OBJECTIVE	Pelvic radiotherapy ( RT ) toxicity in the elderly is poorly documented .\
OBJECTIVE	We developed a study aiming to evaluate whether or not a limit of age could be identified beyond which toxicities in patients receiving pelvic RT were more frequent or more severe .\
METHODS	1619 patients with pelvic cancers enrolled in nine EORTC trials , RT arms , were retrospectively studied .\
METHODS	Patients were split into six age ranges from 50 years to 70 years and over .\
METHODS	Survivals and late toxicity occurrence were calculated with the Kaplan-Meier method and comparison between age groups with the logrank test .\
METHODS	A trend test was done to examine if chronological age had an impact on acute toxicity occurrence .\
RESULTS	Survival was comparable in each age group for prostate ( P = 0.18 ) , uterus ( 0.41 ) , anal canal cancer ( P = 0.6 ) and slightly better for the younger group of rectum cancer ( P = 0.04 ) .\
RESULTS	A total of 1722 acute and 514 late grade > or = 1 were recorded .\
RESULTS	Acute nausea / vomiting , skin complications and performance status deterioration were significantly more frequent in younger patients .\
RESULTS	There was no trend toward more aged patients to experience diarrhea ( P = 0.149 ) and after adjustment on RT dose , acute urinary complications were observed equally in each age range ( P = 0.32 ) .\
RESULTS	Eighty percent of patients were free of late complication at 5 years in each age range ( P = 0.79 ) .\
RESULTS	For the grade > 2 late side-effects , a plateau was observed after 1 year at near 9 % without any difference ( P = 0.06 ) nor trend ( P = 0.13 ) between age-groups .\
CONCLUSIONS	Age per se is not a limiting factor for radical radiotherapy in pelvic malignancies .\
\
###20961444\
BACKGROUND	Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society .\
BACKGROUND	Medication and psychological therapies are effective for treating depression and maintenance anti-depressants ( m-ADM ) can prevent relapse .\
BACKGROUND	However , individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term .\
BACKGROUND	We need to develop psychological therapies that prevent depressive relapse/recurrence .\
BACKGROUND	A recently developed treatment , Mindfulness-based Cognitive Therapy ( MBCT , see http://www.mbct.co.uk ) shows potential as a brief group programme for people with recurring depression .\
BACKGROUND	In two studies it has been shown to halve the rates of depression recurring compared to usual care.This trial asks the policy research question , is MBCT superior to m-ADM in terms of : a primary outcome of preventing depressive relapse/recurrence over 24 months ; and , secondary outcomes of ( a ) depression free days , ( b ) residual depressive symptoms , ( c ) antidepressant ( ADM ) usage , ( d ) psychiatric and medical co-morbidity , ( e ) quality of life , and ( f ) cost effectiveness ?\
BACKGROUND	An explanatory research question asks is an increase in mindfulness skills the key mechanism of change ?\
METHODS	The design is a single blind , parallel RCT examining MBCT vs. m-ADM with an embedded process study .\
METHODS	To answer the main policy research question the proposed trial compares MBCT plus ADM-tapering with m-ADM for patients with recurrent depression .\
METHODS	Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care .\
METHODS	Depressive relapse/recurrence over two years is the primary outcome variable .\
METHODS	The explanatory question will be addressed in two mutually informative ways : quantitative measurement of potential mediating variables pre/post-treatment and a qualitative study of service users ' views and experiences .\
CONCLUSIONS	If the results of our exploratory trial are extended to this definitive trial , MBCT will be established as an alternative approach to maintenance anti-depressants for people with a history of recurrent depression .\
CONCLUSIONS	The process studies will provide evidence about the effective components which can be used to improve MBCT and inform theory as well as other therapeutic approaches .\
BACKGROUND	ISRCTN26666654 .\
\
###23164097\
BACKGROUND	Iliac artery atherosclerotic disease may cause intermittent claudication and critical limb ischemia .\
BACKGROUND	It can lead to serious complications such as infection , amputation and even death .\
BACKGROUND	Revascularization relieves symptoms and prevents these complications .\
BACKGROUND	Historically , open surgical repair , in the form of endarterectomy or bypass , was used .\
BACKGROUND	Over the last decade , endovascular repair has become the first choice of treatment for iliac arterial occlusive disease .\
BACKGROUND	No definitive consensus has emerged about the best endovascular strategy and which type of stent , if any , to use .\
BACKGROUND	However , in more advanced disease , that is , long or multiple stenoses or occlusions , literature is most supportive of primary stenting with a balloon-expandable stent in the common iliac artery ( Jongkind V et al. , J Vasc Surg 52:1376 -1383,2010 ) .\
BACKGROUND	Recently , a PTFE-covered balloon-expandable stent ( Advanta V12 , Atrium Medical Inc. , Hudson , NH , USA ) has been introduced for the iliac artery .\
BACKGROUND	Covering stents with PTFE has been shown to lead to less neo-intimal hyperplasia and this might lower restenosis rates ( Dolmatch B et al. .\
BACKGROUND	J Vasc Interv Radiol 18:527 -534,2007 , Marin ML et al. .\
BACKGROUND	J Vasc Interv Radiol 7:651 -656,1996 , Virmani R et al. .\
BACKGROUND	J Vasc Interv Radiol 10:445 -456,1999 ) .\
BACKGROUND	However , only one RCT , of mediocre quality has been published on this stent in the common iliac artery ( Mwipatayi BP et al. .\
BACKGROUND	J Vasc Surg 54:1561 -1570,2011 , Bekken JA et al. .\
BACKGROUND	J Vasc Surg 55:1545 -1546,2012 ) .\
BACKGROUND	Our hypothesis is that covered balloon-expandable stents lead to better results when compared to uncovered balloon-expandable stents .\
METHODS	This is a prospective , randomized , controlled , double-blind , multi-center trial .\
METHODS	The study population consists of human volunteers aged over 18 years , with symptomatic advanced atherosclerotic disease of the common iliac artery , defined as stenoses longer than 3 cm and occlusions .\
METHODS	A total of 174 patients will be included .\
METHODS	The control group will undergo endovascular dilatation or revascularization of the common iliac artery , followed by placement of one or more uncovered balloon-expandable stents .\
METHODS	The study group will undergo the same treatment , however one or more PTFE-covered balloon-expandable stents will be placed .\
METHODS	When necessary , the aorta , external iliac artery , common femoral artery , superficial femoral artery and deep femoral artery will be treated , using the standard treatment .\
METHODS	The primary endpoint is absence of binary restenosis rate .\
METHODS	Secondary endpoints are reocclusion rate , target-lesion revascularization rate , clinical success , procedural success , hemodynamic success , major amputation rate , complication rate and mortality rate .\
METHODS	Main study parameters are age , gender , relevant co-morbidity , and several patient , disease and procedure-related parameters .\
BACKGROUND	Dutch Trial Register , NTR3381 .\
\
###20450989\
OBJECTIVE	To analyze influence of pre-operative MRCP on the management of patients with gall stones .\
METHODS	This prospective randomized study was carried on 250 patients who underwent laparoscopic cholecystectomy within 3 years .\
METHODS	In group I , pre-operative MRCP was performed in 125 patients with age range of 18-62 years .\
METHODS	Group II included 125 patients managed by laparoscopic cholecystectomy without doing pre-operative MRCP with age range of 21-65 years .\
RESULTS	In group I ; pre-operative MRCP screening revealed clinically silent CBD stones in 5 patients ( 4 % ) , accessory cystic duct in 2 ( 1.6 % ) , abnormal insertion of cystic duct in 1 ( 0.8 % ) .\
RESULTS	Postoperatively , bile duct injury was inflected in 1 patient in group I. On the other hand , there were 2 patients with bile duct injury and 5 patients with residual stones in group II .\
RESULTS	There was a statistically significant increase of post-operative complications in group II ( p < or = 0.5 ) .\
CONCLUSIONS	MRCP is diagnostically useful in management of patients with gall stones prior to laparoscopic cholecystectomy and its routine use can reduce the incidence of post-operative complications .\
\
###21499192\
OBJECTIVE	To evaluate the effect of preoperative intravitreal injection of bevacizumab on surgery and on the early postoperative course in diabetic patients undergoing vitrectomy for dense vitreous hemorrhage .\
METHODS	Thirty-five patients with dense diabetic vitreous hemorrhage were randomly assigned to a group that received 1.25 mg of intravitreal bevacizumab 1 week before vitrectomy ( 18 patients ) or the control group ( 17 patients ) .\
METHODS	To compare the complexity of two groups , intraoperative complexity score and proliferative diabetic vitreoretinopathy stage were recorded .\
METHODS	Intraoperative bleeding , break formation , number of endodiathermy applications , best-corrected visual acuity , anatomical outcome at Month 3 and at final follow-up , and postoperative complications were evaluated .\
RESULTS	Mean complexity scores and proliferative diabetic vitreoretinopathy stages of both groups were similar .\
RESULTS	The mean score of bleeding was 1.05 in the injection group versus 1.76 in the control group ( P = 0.35 ) ; endodiathermy applications and break formations were 0.44 versus 0.52 ( P = 0.68 ) and 0.22 versus 0.29 ( P = 0.60 ) in the injection and control groups , respectively .\
RESULTS	Anatomical outcome and visual acuity at Month 3 and at the final follow-up were similar .\
CONCLUSIONS	The results suggest that intravitreal injection of bevacizumab before vitrectomy for dense diabetic vitreous hemorrhage has no significant effect on facilitation of surgery or on the early postoperative course .\
\
###23463651\
BACKGROUND	Type 2 diabetes ( T2D ) has features of disordered lipid and glucose metabolism , due in part to reduced mitochondrial content .\
OBJECTIVE	Our objective was to investigate effects of different types of exercise on mitochondrial content and substrate oxidation in individuals with T2D ( ancillary study of the randomized controlled trial Health Benefits of Aerobic and Resistance Training in Individuals with Type 2 Diabetes , HART-D ) .\
METHODS	T2D individuals were randomized to aerobic training ( AT , n = 12 ) , resistance training ( RT , n = 18 ) , combination training ( ATRT , n = 12 ) , or nonexercise control ( n = 10 ) .\
METHODS	Blood draws , peak oxygen consumption tests , dual-energy x-ray absorptiometry scans and muscle biopsies of vastus lateralis were performed before and after 9 months .\
METHODS	Ex vivo substrate oxidations ( ( 14 ) CO2 ) , mitochondrial content , and enzyme activities were measured .\
METHODS	Glycated hemoglobin A1c and free fatty acids were also determined .\
RESULTS	Mitochondrial content increased after RT and ATRT .\
RESULTS	Octanoate oxidation increased after AT and ATRT , whereas palmitate , pyruvate , and acetate oxidations increased in all exercise groups .\
RESULTS	Exercise-induced responses in mitochondrial DNA were associated with improvements in peak oxygen consumption , - hydroxyacyl-coenzyme A dehydrogenase activity , and palmitate oxidation .\
CONCLUSIONS	Nine months of AT and RT significantly improved most aspects of skeletal muscle mitochondrial content and substrate oxidation , whereas the combination improved all aspects .\
CONCLUSIONS	These exercise responses were associated with clinical improvements , indicating that long-term training , especially combination , is an effective lifestyle therapy for individuals with T2D by way of improving muscle substrate metabolism .\
\
###16697413\
OBJECTIVE	Pilot study examining the effects of estrogen therapy ( ET ) on antidepressant response in postmenopausal women with major depressive disorder ( MDD ) .\
METHODS	Twenty-two subjects received sertraline at 50mg/day for one week , with an increase to 100mg/day at week 2 for a 10-week trial .\
METHODS	Transdermal estrogen or placebo patches 0.1 mg were randomly administered concurrent with the initiation of sertraline treatment .\
METHODS	The 21 item Hamilton Depression Rating Scale ( HDRS-21 ) was administered to all patients at baseline and weekly thereafter .\
RESULTS	Both groups showed a similar significant reduction in HDRS-21 scores by the end of the study .\
RESULTS	There was no significant difference between the two treatment groups at the end of the 10-week trial , but the women receiving sertraline with ET showed significantly greater early improvement ( weeks 2-4 ) compared to the women receiving sertraline with placebo .\
CONCLUSIONS	Sertraline is an effective antidepressant for postmenopausal women with MDD .\
CONCLUSIONS	ET does not alter the response rate to antidepressant therapy however ET may play a role in accelerating the antidepressant response .\
\
###9989555\
OBJECTIVE	The authors tested the hypothesis that nortriptyline and interpersonal psychotherapy , alone and in combination , are superior to placebo in achieving remission of bereavement-related major depressive episodes .\
METHODS	Eighty subjects , aged 50 years and older , with major depressive episodes that began within 6 months before or 12 months after the loss of a spouse or significant other were randomly assigned to a 16-week doubleblind trial of one of four treatment conditions : nortriptyline plus interpersonal psychotherapy ( N = 16 ) , nortriptyline alone in a medication clinic ( N = 25 ) , placebo plus interpersonal psychotherapy ( N = 17 ) , or placebo alone in a medication clinic ( N = 22 ) .\
METHODS	The protocol required that the acute-phase double-blind treatment be ended after 8 weeks if Hamilton depression scale ratings had not improved by 50 % .\
METHODS	Remission was defined as a 17-item Hamilton scale score of 7 or lower for 3 consecutive weeks .\
RESULTS	The rate of remission for nortriptyline plus interpersonal psychotherapy was 69 % ( N = 11 ) ; for medication clinic , nortriptyline , 56 % ( N = 14 ) ; for placebo plus interpersonal psychotherapy , 29 % ( N = 5 ) ; and for medication clinic , placebo , 45 % ( N = 10 ) .\
RESULTS	In a generalized logit model , there was a significant effect of nortriptyline over placebo but no interpersonal psychotherapy effect and no nortriptyline-by-interpersonal psychotherapy interaction .\
RESULTS	Rates of all-cause attrition were lowest in the nortriptyline plus interpersonal psychotherapy group .\
CONCLUSIONS	Nortriptyline was superior to placebo in achieving remission of bereavement-related major depressive episodes .\
CONCLUSIONS	The combination of medication and psychotherapy was associated with the highest rate of treatment completion .\
CONCLUSIONS	These results support the use of pharmacologic treatment of major depressive episodes in the wake of a serious life stressor such as bereavement .\
\
###17575270\
OBJECTIVE	Major bleeding after percutaneous coronary intervention ( PCI ) is an independent risk factor for early and late mortality .\
OBJECTIVE	We developed and validated a risk score predictive of major bleeding after PCI using the femoral approach .\
RESULTS	Baseline clinical and procedural variables from two contemporary , multicentre , randomized PCI trials were used for risk score development ( the REPLACE-2 trial , n = 6002 ) and validation ( the REPLACE-1 trial , n = 1056 ) .\
RESULTS	On the basis of the odds ratio , independent risk factors were assigned a weighted integer , the sum of which comprised a total risk score .\
RESULTS	Seven variables were identified as independent correlates of major bleeding ( age > 55 years , female gender , estimated glomerular filtration rate < 60 mL/min/1 .73 m ( 2 ) , pre-existing anaemia , administration of low-molecular-weight heparin within 48 h pre-PCI , use of glycoprotein IIb/IIIa inhibitors , and intraaortic balloon pump use ) .\
RESULTS	In the development set , the risk of major bleeding varied from 1.0 % in patients without risk factors to 5.4 % in high-risk patients .\
RESULTS	The discriminatory power of this risk model was confirmed in the validation data set ( area under the receiver operating curve = 0.62 ) .\
CONCLUSIONS	A simple risk score of baseline clinical and procedural variables is useful to predict the incidence of major peri-procedural bleeding after contemporary PCI using the femoral approach .\
\
###21887548\
OBJECTIVE	The purpose of this study is to compare retropubic tension-free vaginal tape ( TVT ) with transobturator out-in TOT and in-out TVT-O for female stress urinary incontinence .\
OBJECTIVE	Uroflow rate was primary ; continence rates , quality of life ( QoL ) and complication pattern were secondary endpoints .\
METHODS	A prospective randomised trial with 2:1:1 randomisation at two Swiss teaching hospitals .\
METHODS	Patients were followed up at 12 months .\
RESULTS	Eighty TVT , 40 transobturator tape ( TOT ) and 40 TVT-O were randomised .\
RESULTS	At 12 months , there was no difference in Qmax among the groups .\
RESULTS	Continence was comparable ( 89 % ) .\
RESULTS	QoL was improved significantly in all groups ( P < 0.05 ) .\
RESULTS	Five vaginal tape exposures occurred ( one TVT , four TOT , zero TVT-O ; P = 0.028 ) .\
RESULTS	Two percent ( 1/52 ) of sexually active patients after TVT , 17 % ( 5/29 ) after TOT , but 0 % ( 0/25 ) after TVT-O reported de novo female sexual dysfunction ( P = 0.011 ) .\
RESULTS	We considered this clinically important enough to stop enrolment .\
CONCLUSIONS	There was no difference for Qmax at 12 months between TVT , TOT and TVT-O .\
CONCLUSIONS	Female sexual dysfunction and tape exposure may be higher with a transobturator tape .\
\
###10657405\
OBJECTIVE	Some stroke patients and their families express reservations about participating in trials of experimental therapies for acute stroke .\
OBJECTIVE	Among many reasons given for this is the concern that by participating , patients may be deprived of some component of routine care .\
OBJECTIVE	We sought to determine the effect on outcome of participating in a clinical stroke trial while being treated with placebo .\
METHODS	Prospective clinical information was collected for all patients admitted with acute ischemic stroke between July 1995 and July 1996 .\
METHODS	A subgroup of these patients was enrolled in a clinical trial of acute stroke therapy and had been randomly assigned to the placebo group .\
METHODS	The control group was selected from concurrent stroke patients who were not enrolled in any clinical trial .\
METHODS	The National Institutes of Health Stroke Scale ( NIHSS ) was performed on admission and on day 7 after admission .\
METHODS	The Glasgow Outcome Scale ( GOS ) was also performed at discharge .\
METHODS	Stroke severity was classified as `` severe '' if NIHSS was > / = 9 or GOS > / = 3 .\
METHODS	Group comparisons were performed with chi ( 2 ) tests .\
RESULTS	One hundred twenty-six patients were evaluated .\
RESULTS	Forty-seven were placebo patients , and 79 were selected as control subjects .\
RESULTS	There were no significant differences between the groups with respect to age , sex , hematocrit , blood glucose level , history of hypertension , diabetes , smoking , or initial NIHSS .\
RESULTS	In addition , there was no difference between groups in terms of the frequency of baseline stroke subtype .\
RESULTS	Among our controls , 55 patients ( 70 % ) were on antithrombotic treatment during hospitalization , whereas none of our placebo patients were on any antithrombotic treatment .\
RESULTS	For the GOS at follow-up , a good outcome was attained by 76 % of the control subjects and 72 % of placebo patients ( not significant ) .\
RESULTS	A severe NIHSS ( > 9 ) at follow-up , however , was documented in 15 % of controls and 59 % of placebo patients ( P < 0.001 ) .\
RESULTS	There was a trend toward a higher ( `` worse '' ) mean follow-up NIHSS among placebo patients ( mean NIHSS , 11 ) versus controls ( mean NIHSS , 6 ) ( P = 0.09 ) .\
CONCLUSIONS	Patients enrolled in the placebo arms of some acute clinical stroke trials have similar functional outcomes but more severe neurological deficits at 1 week than did a control group .\
CONCLUSIONS	These findings might be partially explained by the withholding of antithrombotic medication and the exclusion criteria inherent in most trials .\
CONCLUSIONS	Vigilance is required to ensure that all patients participating in stroke studies be guaranteed optimal known medical therapy .\
\
###23922146\
BACKGROUND	Thoracic endovascular aortic repair ( TEVAR ) represents a therapeutic concept for type B aortic dissection .\
BACKGROUND	Long-term outcomes and morphology after TEVAR for uncomplicated dissection are unknown .\
RESULTS	A total of 140 patients with stable type B aortic dissection previously randomized to optimal medical treatment and TEVAR ( n = 72 ) versus optimal medical treatment alone ( n = 68 ) were analyzed retrospectively for aorta-specific , all-cause outcomes , and disease progression using landmark statistical analysis of years 2 to 5 after index procedure .\
RESULTS	Cox regression was used to compare outcomes between groups ; all analyses are based on intention to treat .\
RESULTS	The risk of all-cause mortality ( 11.1 % versus 19.3 % ; P = 0.13 ) , aorta-specific mortality ( 6.9 % versus 19.3 % ; P = 0.04 ) , and progression ( 27.0 % versus 46.1 % ; P = 0.04 ) after 5 years was lower with TEVAR than with optimal medical treatment alone .\
RESULTS	Landmark analysis suggested a benefit of TEVAR for all end points between 2 and 5 years ; for example , for all-cause mortality ( 0 % versus 16.9 % ; P = 0.0003 ) , aorta-specific mortality ( 0 % versus 16.9 % ; P = 0.0005 ) , and for progression ( 4.1 % versus 28.1 % ; P = 0.004 ) ; Landmarking at 1 year and 1 month revealed consistent findings .\
RESULTS	Both improved survival and less progression of disease at 5 years after elective TEVAR were associated with stent graft induced false lumen thrombosis in 90.6 % of cases ( P < 0.0001 ) .\
CONCLUSIONS	In this study of survivors of type B aortic dissection , TEVAR in addition to optimal medical treatment is associated with improved 5-year aorta-specific survival and delayed disease progression .\
CONCLUSIONS	In stable type B dissection with suitable anatomy , preemptive TEVAR should be considered to improve late outcome .\
BACKGROUND	http://www.clinicaltrials.gov .\
BACKGROUND	Unique identifier : NCT01415804 .\
\
###21226357\
OBJECTIVE	To compare the hemostatic effects and tourniquet induced side reactions of 2 different tourniquets in internal fixation of bilateral tibia and fibula fracture .\
METHODS	Between May 2008 and May 2010 , 21 patients with bilateral tibia and fibula fracture were treated and randomly divided into 2 groups according to left and right limbs .\
METHODS	When steel plate fixation was performed , equilibrium pressure pneumatic tourniquet ( EPPT group ) and common tourniquet ( common group ) were used to staunch the flow of blood respectively .\
METHODS	The time of using tourniquet was 60 minutes , and the hemostatic pressure was 50 kPa .\
METHODS	There were 12 males and 9 females with an age range of 17 to 58 years ( mean , 32.5 years ) .\
METHODS	Injury was caused by traffic accident in 9 patients , by heavy pound in 6 patients , and falling from height in 6 patients .\
METHODS	According to X-ray classification , there were 15 cases of simple type , 3 cases of butterfly type , and 3 cases of comminuted type in EPPT group ; there were 13 cases of simple type , 5 cases of butterfly type , and 3 cases of comminuted type in common group .\
METHODS	The time from injury to operation was 3 to 72 hours ( mean , 37.5 hours ) .\
RESULTS	The time of using tourniquet was ( 95.30 + / - 4.19 ) minutes in EPPT group and ( 94.11 + / - 5.16 ) minutes in common group , showing no significant difference ( P > 0.05 ) .\
RESULTS	All the incision of 2 groups healed by first intension .\
RESULTS	After 2 weeks of operation in common group , peroneal nerve injury occurred in 3 cases , and was cured by supporting nerve for 3 months ; blister occurred in 1 case and was cured after dressing change for 3 weeks ; and the injury rate was 19 % .\
RESULTS	No complication occurred in EPPT group with an injury rate of 0 .\
RESULTS	There was significant difference in the injury rate between 2 groups ( P < 0.05 ) .\
RESULTS	The hemostatic effects were excellent in 19 cases and good in 2 cases of EPPT group , were excellent in 10 cases , good in 3 cases , and poor in 8 cases of common group ; the excellent and good rate were 100 % and 61.9 % respectively , showing significant difference ( P < 0.05 ) .\
RESULTS	All patients were followed up 3-24 months .\
RESULTS	Fracture healed without nonunion and deformity union in 2 groups .\
CONCLUSIONS	Comparing to common tourniquet , the EPPT can provide good bloodless field , lower hemostatic pressure , and less tourniquet complication .\
\
###21352660\
BACKGROUND	Heliox and forward-leaning posture ( torso inclined forward at 50-60 with the elbows resting on the thighs ) are adjuncts in the administration of nebulized bronchodilator to patients with acute asthma .\
METHODS	We randomized 59 patients who presented to the emergency department in severe asthma crisis , into 4 treatment groups : nebulized bronchodilator + oxygen ; nebulized bronchodilator + oxygen + forward-leaning posture ; nebulized bronchodilator + heliox ; and nebulized bronchodilator + heliox + forward-leaning posture .\
METHODS	Before and after the bronchodilator treatments the subjects were seated with torso erect , breathing room air .\
METHODS	Each subject received 2 doses , 20 min apart , of nebulized fenoterol ( 2.5 mg ) plus ipratropium bromide ( 0.25 mg ) in 3 mL of 0.9 % saline , delivered with a semi-closed valved aerosol reservoir .\
METHODS	The nebulizer was run with oxygen or 80:20 heliox .\
METHODS	The post-treatment pulmonary function tests were performed 15 min after the second nebulization .\
METHODS	The group 's mean age was 35.1 13.6 y , and there were 20 men and 39 women .\
RESULTS	The oxygen + forward-leaning-posture group had a greater FEV ( 1 ) improvement than the oxygen group ( 59 % vs 38 % , P = .02 ) .\
RESULTS	The heliox + forward-leaning-posture group had a greater FEV ( 1 ) improvement than the oxygen group ( 103 % vs 38 % , P = .001 ) and the heliox group ( 103 % vs 42 % , P = .03 ) .\
RESULTS	The heliox group had greater reduction in respiratory rate than the oxygen group ( P = .03 ) .\
RESULTS	The heliox + forward-leaning-posture group had significantly greater peak expiratory flow improvement than any of the other groups .\
CONCLUSIONS	Heliox plus forward-leaning posture during bronchodilator nebulization improves bronchodilator efficacy in patients with severe acute asthma .\
CONCLUSIONS	( ClinicalTrials.gov registration NCT00922350 ) .\
\
###19716512\
OBJECTIVE	The aim of this study was to evaluate the influence of using MTA in teeth with post-core indication and to compare it with the immediate or delayed post space preparation on the integrity of apical seal in teeth filled with gutta-percha and sealer .\
METHODS	Fifty-one single-rooted freshly extracted human maxillary incisor teeth were selected .\
METHODS	The crowns of the teeth were removed to a length of 14 mm and canals were prepared by using K-files with the step-back technique .\
METHODS	The teeth were randomly divided into 3 groups of 15 specimens each .\
METHODS	Group A was filled with gutta-percha and sealer using lateral compaction , and post space was prepared immediately using a heated instrument .\
METHODS	Specimens in Group B were filled with the same materials as Group A and post space was prepared after 1 week with Gates-Glidden drills .\
METHODS	Group C was filled with MTA as an apical 5-mm filling .\
METHODS	In all groups , materials were left in the root canals at the apical 5-mm level .\
METHODS	The remaining 6 teeth were used as controls .\
METHODS	The microleakage values of each group were measured after 1 month , using a computerized fluid filtration method .\
RESULTS	The MTA ( Group C ) showed less microleakage than immediate and delayed post space preparation methods ( Group A , B ) in 1 month , and this difference was found to be statistically significant ( P < .005 ) .\
RESULTS	Additionally , no statistically significant difference was determined between Group A and Group B ( P > .05 ) .\
CONCLUSIONS	These results suggest that MTA can be used in the root canals as apical filling material in teeth with post-core indication .\
\
###17197581\
OBJECTIVE	To compare the intraoperative and immediate postoperative performance of the retropubic tension-free vaginal tape ( TVT ) procedure with that of the transobturator tension-free vaginal tape ( TVT-O ) procedure as primary treatment for female urinary stress incontinence .\
METHODS	Randomized multicenter comparative trial including four university hospitals and three central hospitals in Finland .\
METHODS	Assessment preoperatively and 2 months postoperatively included a cough stress test and the following condition-specific quality of life questionnaires : the Urinary Incontinence Severity Score ( UISS ) , the Detrusor Instability Score , the Incontinence Impact Questionnaire-Short Form , the Urogenital Distress Inventory-Short Form , and a visual analog scale ( VAS ) .\
METHODS	Operation time , theater time , hospital stay , intraoperative and immediate postoperative complications were recorded .\
RESULTS	Of the 273 originally randomized patients , 267 underwent the allocated operation , 136 in the TVT group and 131 in the TVT-O group .\
RESULTS	No significant differences in objective or subjective cure rates were detected .\
RESULTS	Patients in the TVT-O group had a significantly longer hospital stay , needed significantly more postoperative opiate analgesia and had significantly more complications than the patients in the TVT group .\
RESULTS	Patients in both groups had a significant postoperative improvement in quality of life , as indicated by the results of all the questionnaires used , with no difference between the groups .\
CONCLUSIONS	The TVT and the TVT-O procedures perform equally in terms of objective and subjective cure .\
CONCLUSIONS	The statistically significant higher complication rate in the TVT-O group is not regarded as clinically significant .\
BACKGROUND	( www.ClinicalTrials.gov ) , NCT00379314\
METHODS	I.\
\
###24645966\
OBJECTIVE	To compare the efficacy and tolerability of a low-volume ( 2-L ) polyethylene glycol ( PEG ) regimen for colonoscopy compared to single ( 4-L ) or split-dose ( 2-L +2 - L ) regimens .\
METHODS	In-hospital patients who were candidates for colonoscopy were randomly assigned to : group 1 single-dose ( PEG 4L the day before the study , n = 60 ) ; group 2 : split-dose ( 2L the day before and 2L on the day of the procedure , n = 61 ) ; and group 3 : low-volume 2-L PEG solution ( the day of the procedure , n = 59 ) .\
METHODS	A blinded evaluation of the quality of colonic preparation was assessed by the Boston bowel preparation scale .\
RESULTS	Satisfactory bowel preparation of the right colon was more frequently reported for group 3 than for group 1 ( 70 % vs 53 % , P = 0.045 ) , in the transverse colon it was 82 % versus 69 % ( P = 0.032 ) , and on the left side of the colon it was 80 % versus 67.7 % ( P = 0.028 ) .\
RESULTS	Compared to group 2 , satisfactory bowel preparation in group 3 was similar in the transverse colon and left colon .\
RESULTS	Nausea , vomiting , and abdominal discomfort were less frequent in patients of group 3 .\
RESULTS	Patients in group 3 had fewer sleep disorders and fewer hours of sleep loss compared to patients in the other groups .\
CONCLUSIONS	Preparation with 2L caused less abdominal discomfort and fewer sleep disorders .\
CONCLUSIONS	The split dose had a better quality of preparation in the right colon .\
CONCLUSIONS	Both preparations were clearly better than the 4-L preparation .\
\
###22453270\
OBJECTIVE	The objective of this study was to estimate the association between body mass index ( BMI ) and pelvic organ prolapse symptoms and bother among overweight and obese women with urinary incontinence before and after weight loss .\
METHODS	Women ( N = 338 ) were randomized to either an intensive 6-month weight loss or educational program ( control ) ; they were evaluated for prolapse symptoms at baseline and 6 months .\
METHODS	Symptomatic prolapse was defined as a positive response to at least 1 prolapse subscale question of the Urogenital Distress Inventory .\
METHODS	`` Bother '' was defined as responses of slight , moderate , or great .\
METHODS	Women with prolapse symptoms were analyzed by baseline BMI category : overweight , obese , and severely obese at baseline and at 6 months .\
METHODS	Proportional odds regression and tests for trend were used for analysis .\
RESULTS	Age mean was 53 ( SD , 10 ) years , BMI mean was 36 ( SD , 6 ) kg/m , and 78 % were white .\
RESULTS	A higher proportion of obese women reported feeling vaginal bulging compared with overweight women ( 13 % vs 0 % , P = < 0.01 ) .\
RESULTS	At baseline , 37 % ( n = 124 ) reported bothersome `` lower abdominal pressure '' ; 18 % ( n = 62 ) , bothersome `` heaviness in the pelvic area '' ; and 14 % ( n = 48 ) , bothersome `` pelvic discomfort when standing . ''\
RESULTS	Nine percent ( n = 31 ) reported bothersome `` feeling , '' and 2 % ( n = 6 ) reported bothersome `` seeing a bulge '' in the vagina .\
RESULTS	At 6 months , there were no significant differences in improvement of self-reported bothersome prolapse symptoms in women in the weight loss or the control group .\
CONCLUSIONS	In this study of overweight and obese women , increasing BMI was associated with only `` feeling '' a vaginal bulge .\
CONCLUSIONS	Weight loss did not improve bothersome prolapse symptoms .\
\
###17653885\
BACKGROUND	French maritime pine bark extract ( Pycnogenol ) was found to alleviate menstrual pain and reduce hyperactivity in clinical studies .\
BACKGROUND	These results suggest the possibility to observe positive effects in treating climacteric syndrome .\
OBJECTIVE	Clinical investigation of the effect of Pycnogenol , French maritime pine bark extract , on the climacteric syndrome .\
METHODS	Some 200 peri-menopausal women were enrolled in a double-blind , placebo-controlled study , and treated with Pycnogenol ( 200mg ) daily .\
METHODS	Climacteric symptoms were evaluated by the Women 's Health Questionnaire ( WHQ ) , patients were checked for antioxidative status and routine chemistry .\
METHODS	A total of 155 women completed the study .\
RESULTS	All climacteric symptoms improved , antioxidative status increased and LDL/HDL ratio was favourably altered by Pycnogenol .\
RESULTS	No side effects were reported .\
CONCLUSIONS	Pycnogenol may offer an alternative method to reducing climacteric symptoms without unwanted effects .\
\
###14676153\
OBJECTIVE	To determine whether microdissection needle cautery for tonsillectomy results in decreased postoperative pain when compared with standard electrocautery .\
METHODS	A randomized prospective study of 2 groups of young children in an academic pediatric otolaryngology practice .\
METHODS	Forty-two healthy children between the ages of 4 and 12 years .\
METHODS	The 42 children were randomly assigned to 2 groups : in group A , the tonsillectomy was performed with standard monopolar electrocautery tip at 20 W ; in group B , the microdissection needle was used at 8 W.\
METHODS	The same surgeon performed each tonsillectomy .\
METHODS	Other aspects of the procedure were constant , including patient positioning , intraoperative injection of 0.25 % bupivacaine hydrochoride ( Marcaine ) , a weight-appropriate dose of steroids , and the use of postoperative antibiotics .\
METHODS	The subjective measure of postoperative pain was a questionnaire based on a standard visual analog scale ranging from 0 to 10 .\
METHODS	More objective measures included the doses of pain medications consumed and the tolerance of oral intake .\
RESULTS	There was no statistical significant difference in the amount of intraoperative hemorrhage between groups ( P > .\
RESULTS	01 ) .\
RESULTS	Operative time was on average 3.2 minutes longer in group B ( 11 minutes vs 7.8 minutes ) .\
RESULTS	The postoperative pain as measured by the visual analog scale was significantly different on days 3 , 4 , and 5 in group B ( P < .05 ) .\
RESULTS	This difference in pain correlated to differences in the number of doses of pain medications used on the same days .\
RESULTS	There was no statistically significant difference between the 2 groups concerning the amount of fluids tolerated ( P > .01 ) .\
CONCLUSIONS	Without any increase in complications , subjective and objective measurement showed that the use of the microdissection needle resulted in significantly less postoperative pain by day 3 .\
\
###24693784\
OBJECTIVE	To explore the feasibility and effectiveness of unilateral pedicle screw rod and single poly ( ether-ether-ketone ) ( PEEK ) Cage for lumbar intervertebral disc protrusion .\
METHODS	A total of 126 cases of single segment of lumbar intervertebral disc protrusion between January 2006 and June 2012 were divided into 2 groups in the randomized clinical trial .\
METHODS	Unilateral pedicle screw fixation and single PEEK Cage was used in 63 cases ( research group ) , and bilateral pedicle screw fixation and single PEEK Cage in 63 cases ( control group ) .\
METHODS	There was no significant difference in gender , age , disease duration , side , and affected segment between 2 groups ( P > 0.05 ) .\
METHODS	Schulte evaluation criterion was used to assess bone graft fusion , Oswestry disability index ( ODI ) to estimate the quality of life situation , and visual analogue scale ( VAS ) to evaluate the improvements of lower back pain .\
METHODS	Macnab standards was applied to assess postoperative effectiveness , and Emery ways to measure the height of intervertebral space .\
RESULTS	The incision length , operation time , intraoperative blood loss , hospitalization time , and hospitalization fee in research group were significantly less than those in control group ( P cc 0.05 ) .\
RESULTS	The patients were followed up 12-79 months ( mean , 21.3 months ) in research group , and 15-73 months ( mean , 22.6 months ) in control group .\
RESULTS	The postoperative lordosis was recovered well , and the height of intervertebral space was increased .\
RESULTS	No loosening or breakage of internal fixation occurred .\
RESULTS	The time of bone graft fusion was ( 6.8 + / - 1.3 ) months in research group and was ( 7.1 + / - 1.2 ) months in control group , showing no significant difference ( t = 1.153 , P = 0.110 ) .\
RESULTS	The height of intervertebral space , ODI score , and VAS score were significantly improved when compared with preoperative ones in 2 groups ( P < 0.05 ) , but no significant difference was found between 2 groups at preoperation and last follow-up ( P > 0.05 ) .\
RESULTS	At 3 months after operation , postoperative effectiveness was assessed according to Macnab criterion , the excellent and good rate was 95.23 % in research group ( excellent in 13 cases , good in 47 cases , and fair in 3 cases ) and was 71.42 % in control group ( excellent in 7 cases , good in 38 cases , fair in 15 cases , and poor in 3 cases ) ; the research group was significantly superior to control group ( chi2 = 6.110 , P = 0.006 ) .\
CONCLUSIONS	Unilateral pedicle screw fixation and single PEEK Cage has the advantages of small trauma , reliable fixation , shorter operation time , less bleeding , less economic cost , and early off-bed activity time .\
CONCLUSIONS	It can provide a simple and reliable choice in single segmental lumbar intervertebral disc protrusion .\
\
###11330851\
BACKGROUND	The quality of parent-child communications about sex and sexuality appears to be a strong determinant of adolescents ' sexual behavior .\
BACKGROUND	Evaluations of interventions aimed at improving such communications can help identify strategies for preventing early onset of sexual behavior .\
METHODS	A school-based abstinence-only curriculum was implemented among 351 middle school students , who were randomly assigned to receive either the classroom instruction alone or the classroom instruction enhanced by five homework assignments designed to be completed by the students and their parents .\
METHODS	An experimental design involving pretest and posttest surveys was used to assess the relative efficacy of the curriculum delivered with and without the parent-child homework assignments .\
RESULTS	In analyses of covariance controlling for baseline scores , immediately after the intervention , adolescents who received the enhanced curriculum reported greater self-efficacy for refusing high-risk behaviors than did those who received the classroom instruction only ( mean scores , 16.8 vs. 15.8 ) .\
RESULTS	They also reported less intention to have sex before finishing high school ( 0.4 vs. 0.5 ) , and more frequent parent-child communications about prevention ( 1.6 vs. 1.0 ) and sexual consequences ( 1.6 vs. 1.1 ) .\
RESULTS	In all significant comparisons , the direction of the findings favored adolescents who received the enhanced curriculum .\
RESULTS	Dose-response relationships supported the findings .\
CONCLUSIONS	Parent-child homework assignments designed to reinforce and support school-based prevention curricula can have an immediate impact on several key determinants of sexual behavior among middle school adolescents .\
\
###12651035\
OBJECTIVE	We sought to assess the relationship between the Thrombolysis In Myocardial Infarction ( TIMI ) myocardial perfusion ( TMP ) grade and myocardial salvage as well as the usefulness of TMP grade in comparing two different reperfusion strategies .\
BACKGROUND	The angiographic index of TMP grade correlates with infarct size and mortality after thrombolysis for acute myocardial infarction ( AMI ) .\
BACKGROUND	Its relationship to myocardial salvage and its usefulness in comparing different reperfusion strategies are not known .\
METHODS	We analyzed the TMP grade on angiograms obtained at one to two weeks after treatment in 267 patients enrolled in two randomized trials that compared stenting with thrombolysis in AMI .\
METHODS	Patients were classified into two groups : 159 patients with TMP grade 2/3 and 108 patients with TMP grade 0/1 .\
METHODS	Two scintigraphic studies were performed : before and one to two weeks after reperfusion .\
METHODS	The salvage index was calculated as the proportion of the area at risk salvaged by reperfusion .\
RESULTS	Patients with TMP grade 2/3 had a higher salvage index ( 0.49 + / - 0.42 vs. 0.34 + / - 0.49 , p = 0.01 ) , a smaller final infarct size ( 15.4 + / - 15.5 % vs. 22.1 + / - 16.2 % of the left ventricle , p = 0.001 ) , and a trend toward lower one-year mortality ( 3.8 % vs. 8.3 % , p = 0.11 ) than patients with TMP grade 0/1 .\
RESULTS	The relationship between TMP and salvage index was independent of the form of reperfusion therapy .\
RESULTS	The proportion of patients with TMP grade 2/3 was significantly higher after stenting than after thrombolysis ( 70.9 % vs. 48.1 % , p = 0.001 ) .\
CONCLUSIONS	These findings show that the TMP grade is a useful marker of the degree of myocardial salvage achieved with reperfusion and a sensitive indicator of the efficacy of reperfusion strategies in patients with AMI .\
\
###17311051\
OBJECTIVE	The aim of this study was to verify if six months of isoflavone supplementation could increase fat-free mass ( FFM ) and muscle mass index ( MMI = appendicular FFM/height ( 2 ) ) in obese-sarcopenic postmenopausal women .\
METHODS	Double-blind randomized study .\
METHODS	Eighteen sarcopenic-obese women completed the study ( 12 on isoflavones and six on placebo ) .\
METHODS	Body composition was measured by dual-energy X-ray absorptiometry .\
METHODS	Subjects ingested 70 mg of isoflavones per day ( 44 mg of diadzein , 16 mg glycitein and 10 mg genestein ) or a placebo for 24 weeks .\
RESULTS	The isoflavone group increased significantly appendicular ( P = 0.034 ) , leg ( P = 0.016 ) FFM and MMI ( P = 0.037 ) , but not the placebo group .\
CONCLUSIONS	Six months of isoflavone supplementation increased FFM and MMI in obese-sarcopenic postmenopausal women .\
\
###10492055\
OBJECTIVE	The primary aim of the present study was to evaluate comparative trough effects of formoterol and salmeterol on beta2-adrenoceptor regulation and bronchodilator response after regular twice-daily treatment , with a secondary aim to evaluate any possible association with beta2-adrenoceptor polymorphism .\
METHODS	Sixteen asthmatic subjects , with mean ( SD ) age 33 ( 9 ) years , all taking inhaled corticosteroids and with a forced expiratory volume in 1 s ( FEV1 ) of 81 ( 12 ) % predicted were recruited to take part in a randomised single-blind , three-way cross-over study .\
METHODS	The subjects received three treatments each for 1 week , with 1-week washout periods in between : ( 1 ) formoterol dry powder , 12 microg twice daily , ( 2 ) salmeterol dry powder , 50 microg twice daily , or ( 3 ) placebo , twice daily .\
METHODS	Spirometry and lymphocyte beta2-adrenoceptor parameters were measured before the first dose and 12 h after the last dose of each treatment , as well as domiciliary peak flow during each treatment .\
RESULTS	There were no differences in beta2-adrenoceptor density ( Bmax ) between the three treatments prior to the first dose ; whereas , after the last dose , Bmax was lower with both active treatments than with placebo , but was significant for salmeterol only -- a 1.2-fold geometric mean fold difference ( 95 % CI 1 - to 1.4-fold ) , P = 0.04 .\
RESULTS	Compared with placebo , there were n = 9 of 16 subjects with salmeterol and n = 6 of 16 with formoterol who had a greater than 15 % fall in Bmax .\
RESULTS	Post-hoc trend analysis of polymorphism showed that the propensity for downregulation appeared to be related to the occurrence of an allelic substitution of glycine at codon 16-8 of 13 for salmeterol versus 5 of 13 for formoterol with a greater than 15 % fall compared with placebo .\
RESULTS	There were no significant differences between salmeterol and formoterol in terms of mean or individual values for downregulation .\
RESULTS	There was evidence of persistent bronchodilator activity with both active treatments compared with placebo ; this was significant for forced expiratory flow rate between 25 % and 75 % of vital capacity ( FEF25-75 ) -- the mean difference versus salmeterol was 0.39 1/s ( 95 % CI 0.06-0 .70 ) , P = 0.02 , and versus formoterol was 0.35 1/s ( 95 % CI 0.16-0 .53 ) , P = 0.001 .\
RESULTS	These effects were mirrored by significant improvements in morning peak flow rate compared with placebo -- mean difference versus salmeterol was 24 1/min ( 95 % CI 7-42 ) , P = 0.01 , and versus formoterol was 36 1/min ( 95 % CI 25-48 ) , P < 0.0001 .\
CONCLUSIONS	There were no differences between regular treatment with formoterol and salmeterol in their effects on lymphocyte beta2-adrenoceptor regulation at the end of a 12-h dosing interval , with both drugs exhibiting a residual degree of bronchodilator activity at the same time point .\
CONCLUSIONS	Further studies to evaluate receptor regulation and bronchodilator response are required in susceptible patients who have the homozygous glycine-16 polymorphism .\
\
###18946003\
OBJECTIVE	Poor nutrition is a common complication of strokes severe enough to require inpatient rehabilitation .\
OBJECTIVE	We therefore tested whether intensive nutritional supplements given to undernourished patients from the time of their admission to a specialized stroke rehabilitation service would improve patient outcomes .\
METHODS	Randomized , prospective , double-blind , single center study comparing intensive nutritional supplementation to routine nutritional supplementation in 116 undernourished patients admitted to a stroke service .\
METHODS	The analysis included the 90 % of patients who were not lost to follow-up due to acute or subacute hospitalization ( n = 102 ; 51 in each group ) .\
METHODS	The nutritional supplements are commercially available and Food and Drug Administration approved .\
METHODS	The primary outcome variable was change in total score on the Functional Independence Measure ( FIM ) .\
METHODS	The secondary outcome measurements included the FIM motor and cognitive subscores , length of stay ( taken from day of admission ) , 2-minute and 6-minute timed walk tests measured at admission and on discharge , and discharge disposition ( home/not home ) .\
RESULTS	Patients receiving intensive nutritional supplementation improved more than those on standard nutritional supplements on measures of motor function ( total FIM , FIM motor subscore , 2-minute and 6-minute timed walk tests , all significant at p < 0.002 ) .\
RESULTS	They did not , however , improve on measures of cognition ( FIM cognition score ) .\
RESULTS	A higher proportion of patients who received the intensive nutritional supplementation went home compared to those on standard supplementation ( p = 0.05 ) .\
CONCLUSIONS	Intensive nutritional supplementation , using readily available commercial preparations , improves motor recovery in previously undernourished patients receiving intensive in-patient rehabilitation after stroke .\
\
###11395601\
OBJECTIVE	Histaminergic H2 antagonists have been reported to provoke central nervous system dysfunction in humans .\
OBJECTIVE	They also aggravate ischemic neuronal damage in experimental animals .\
OBJECTIVE	Because energy failure and glutamate release are crucial factors in ischemic neuronal damage , the effects of ranitidine on energy state and the extracellular concentration of glutamate were investigated in gerbil brain .\
METHODS	Prospective , randomized , controlled animal study .\
METHODS	University animal laboratory .\
METHODS	Male Mongolian gerbils .\
METHODS	The changes in the direct-current potential shift in the hippocampal CA1 area produced by transient forebrain ischemia for 2.5 mins were compared in gerbils pretreated with saline or ranitidine ( 10 nmol ) intracerebroventricularly .\
METHODS	The histologic outcome was evaluated 7 days after ischemia by observing the delayed neuronal death in these animals .\
METHODS	In a second study , brain concentrations of adenosine 5 ' - triphosphate after various durations of decapitation ischemia were determined , and the effect of ranitidine was evaluated .\
METHODS	In a third experiment , changes in the extracellular concentrations of excitatory amino acids during forebrain ischemia were examined by a microdialysis procedure .\
RESULTS	The forebrain ischemia produced a sudden shift in the membrane potential 62 + / - 5 secs ( mean + / - sd , n = 6 ) after the start of ischemia .\
RESULTS	The preischemic administration of ranitidine facilitated onset of depolarization ( 38 + / - 8 secs ; p < .01 ) .\
RESULTS	The histologic outcome was aggravated by ranitidine ( p < .01 ) .\
RESULTS	Decapitation ischemia reduced brain adenosine 5 ' - triphosphate concentration rapidly .\
RESULTS	Ranitidine facilitated the ischemic reduction in adenosine 5 ' - triphosphate , and the value after 1 min was 55 % of that in the corresponding saline group ( p < .01 ) .\
RESULTS	Ranitidine enhanced the ischemic increase in the glutamate concentration , and the peak value in the ranitidine group was 316 % of that in the saline group ( p < .05 ) .\
CONCLUSIONS	The deleterious effect of ranitidine on ischemic neuronal damage may involve the increase in the extracellular concentration of glutamate and facilitation of energy depletion in an anaerobic state .\
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###24765680\
OBJECTIVE	To assess the clinical effect of the ` prostatic urethral lift ' ( PUL ) on lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) through a crossover design study .\
METHODS	Men aged 50 years with an International Prostate Symptom Score of 13 , a maximum urinary flow rate ( Qmax ) of 12 mL/s , and a prostate of 30-80 mL were enrolled into a crossover study after completing a prospective , randomised , controlled , ` blinded ' pivotal study in which they were control subjects receiving a sham procedure .\
METHODS	Patients were followed for 1 year after crossover PUL at 19 centres in the USA , Canada and Australia .\
METHODS	The sham procedure involved rigid cystoscopy with simulated active treatment sounds .\
METHODS	PUL involved placing permanent UroLift ( NeoTract , Inc. , Pleasanton , CA , USA ) implants into the lateral lobes of the prostate to enlarge the urethral lumen .\
METHODS	Urinary symptom relief , health-related quality of life ( HRQL ) impact , urinary flow parameters , sexual function , and adverse events were assessed and compared between the sham and PUL using paired statistical analysis .\
RESULTS	Symptom , flow , HRQL and sexual function assessments showed response improvements from baseline results , similar to results from other published studies , and most parameters were markedly improved after PUL vs the sham procedure in the same patients .\
RESULTS	Symptom , flow , and HRQL improvements were durable over the 12 months of the study .\
RESULTS	Adverse events associated with the procedure were typically transient and mild to moderate ; one patient ( 2 % ) required re-intervention with transurethral resection of the prostate in the first year .\
RESULTS	There were no occurrences of de novo , sustained ejaculatory or erectile dysfunction .\
CONCLUSIONS	The PUL can be performed under local anaesthesia , causes minimal associated perioperative complications , allows patients to quickly return to normal activity , provides rapid and durable improvement in symptoms , and preserves sexual function .\
\
###21765074\
BACKGROUND	Ocular candidiasis is a major complication of candidemia .\
BACKGROUND	The incidence , risk factors , and outcome of eye involvement during candidemia are largely unknown .\
BACKGROUND	We prospectively studied the ocular manifestations of candidemia in a large , worldwide , randomized multicenter trial that compared voriconazole with amphotericin B followed by fluconazole for the treatment of candidemia .\
METHODS	Nonneutropenic patients with blood cultures positive for Candida species were assigned treatment with voriconazole or with amphotericin B followed by fluconazole in a randomized 2:1 ratio .\
METHODS	Dilated fundoscopy was performed in each patient at baseline , on day 7 , at 2 and 6 weeks after the end of treatment ( EOT ) , and , if clinically indicated , at 12 weeks after EOT .\
RESULTS	Of 370 patients , 49 had findings consistent with the diagnosis of ocular candidiasis at baseline , and an additional 11 patients developed abnormalities during treatment , totaling 60 patients with eye involvement ( 16 % ) .\
RESULTS	Of these patients , probable Candida eye infection was diagnosed in 40 patients ( 6 with endophthalmitis , 34 with chorioretinitis ) , and possible Candida eye infection in 20 ( all with chorioretinitis ) .\
RESULTS	The duration of candidemia was significantly longer in patients with ocular candidiasis ( median , 4 days ; range , 1-18 days ) compared with patients without ocular involvement ( median , 3 days ; range 1-26 days ; log rank , P = .026 ) .\
RESULTS	Therapy with either voriconazole ( 44 cases ) or amphotericin B followed by fluconazole ( 16 cases ) was successful in 65 % of patients ; outcome was not evaluable in 32 % and was unfavorable in 3 % .\
CONCLUSIONS	Ocular involvement occurred in 16 % of patients with candidemia ; however , endophthalmitis was uncommon ( 1.6 % ) .\
CONCLUSIONS	Treatment with either voriconazole or amphotericin B followed by fluconazole was successful for ocular candidiasis in most cases with follow-up .\
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###25455692\
OBJECTIVE	To confirm the superiority of transdermal rotigotine up to 16mg/24h over placebo , and non-inferiority to ropinirole , in Japanese Parkinson 's disease ( PD ) patients on concomitant levodopa therapy .\
METHODS	This trial was a randomized , double-blind , double-dummy , three-arm parallel group placebo - and ropinirole-controlled trial .\
METHODS	Four-hundred and twenty PD patients whose motor symptoms were not well controlled by levodopa treatment were randomized 2:2:1 to receive rotigotine , ropinirole ( up to 15mg/day ) or placebo during a 16-week treatment period followed by a 4-week taper period .\
METHODS	The primary variable was change in the Unified Parkinson 's Disease Rating Scale ( UPDRS ) Part III ( ON state ) sum score from baseline to the end of the treatment period .\
RESULTS	The difference in the change in the UPDRS Part III ( ON state ) sum score from baseline to the end of treatment between rotigotine and placebo groups was-6 .41.2 ( 95 % CI : -8.7 to-4 .1 ; p < 0.001 ) , indicating superiority of rotigotine over placebo .\
RESULTS	The difference between rotigotine and ropinirole groups was-1 .41.0 ( 95 % CI : -3.2 to 0.5 ) , below the non-inferiority margin , indicating the non-inferiority of rotigotine to ropinirole .\
RESULTS	Application site reaction was seen in 57.7 % of the patients in the rotigotine group and in 18.6 % in the ropinirole group ( P < 0.001 ) .\
RESULTS	No other safety issue was noted .\
CONCLUSIONS	Rotigotine was well tolerated at doses up to 16mg/24h and showed similar efficacy to ropinirole except that the application site reaction was much higher in the rotigotine group .\
\
###19565549\
OBJECTIVE	To evaluate whether an early cognitive-behavioral treatment complementary to a rheumatologic care program , for patients with recent-onset temporary work disability caused by musculoskeletal disorders ( MSDs ) is effective .\
METHODS	Patients with an MSD-related temporary work disability episode from 3-8 weeks ' duration who were in a rheumatologic care program were randomized into a control group ( rheumatologic care program ) or an intervention group ( rheumatologic care program plus cognitive-behavioral treatment ) .\
METHODS	Enrollment lasted 24 months and followup lasted 6-24 months .\
METHODS	Efficacy variables included duration of temporary work disability episodes , total number of work days saved , relative efficacy , and relative rate to return to work .\
METHODS	An economic evaluation was also performed .\
RESULTS	One hundred eighty-one patients were included ( 66 control and 115 intervention patients ) , generating 222 episodes of MSD-related temporary work disability .\
RESULTS	Episodes tended to be shorter in the intervention group than in the control group ( mean 98 versus 127 days ; P = 0.053 ) , with a relative efficacy of 22.9 % .\
RESULTS	There were no differences in duration of the first episode between groups ( mean 105 versus 110 days ; P = 0.79 ) , but relapse episodes were significantly shorter in the intervention group ( mean 63 days versus 197 days ; P = 0.0002 ) .\
RESULTS	Costs were also lower in the intervention group .\
RESULTS	To save 1 day of temporary work disability , $ 13.50 had to be invested in the program .\
RESULTS	Each dollar invested generated a benefit of $ 4.08 .\
RESULTS	The program had a net benefit of $ 172,607 .\
CONCLUSIONS	Early cognitive-behavioral treatment complementary to a rheumatologic care program is cost-effective , adds > 20 % efficacy to the rheumatologic care program , and reduces the duration of relapses .\
\
###21898324\
BACKGROUND	An integrated approach to dementia is generally recommended because no one discipline is adequately equipped it deal with the complex psychic , physical and social problems that are inherent in dementia .\
BACKGROUND	A multidisciplinary approach , however , leads inevitably to higher costs .\
BACKGROUND	It is not known what the cost/benefit ratio will be .\
OBJECTIVE	To describe our research into the costs and benefits of an integrated approach to dementia involving the use of a diagnostic research centre for psycho-geriatrics and thereafter to compare our findings with the results of other studies of the costs and benefits of an integrated approach .\
METHODS	We performed a prospective and randomised efficiency study and we compared our findings with the results of other studies of the costs and benefits of an integrated approach .\
METHODS	We reviewed recent literature .\
RESULTS	The DRC-PG was more effective than normal care as far as the patients ' quality of life was concerned , but was not more expensive .\
RESULTS	It can therefore be regarded as a cost-effective facility for ambulatory patients with dementia .\
RESULTS	Three other studies provided additional empirical evidence of the success of a similar integrated approach in various sectors involved in the care of patients with dementia .\
CONCLUSIONS	An integrated approach with regard to the diagnosis , treatment and management of dementia produces favourable results .\
CONCLUSIONS	More research is needed into the efficacy and cost-effectiveness of integrated care programmes .\
CONCLUSIONS	This should result in improvements in the care and treatment of patients with dementia .\
\
###19049377\
BACKGROUND	Type 2 diabetes patients on premixed insulin are commonly prescribed biphasic insulin with low prandial insulin content , such as biphasic insulin aspart ( BIAsp ) 30 , comprising 30 % insulin aspart ( IAsp ) .\
BACKGROUND	The new formulations BIAsp 50 and BIAsp 70 contain 50 % and 70 % soluble IAsp , respectively .\
BACKGROUND	We compared the pharmacodynamics ( PD ) and pharmacokinetics ( PK ) of BIAsp 30 , 50 , and 70 and IAsp in a glucose clamp trial .\
METHODS	In this randomized , double-blind , crossover study at a clinical research institute , 32 type 1 diabetes patients on basal-bolus therapy each underwent four glucose clamps ( clamp level 5 mmol/L , duration 28 h post-dosing [ 12 h for IAsp ] ) and received a single dose of 0.4 U/kg BIAsp 30 , 50 , or 70 and IAsp .\
METHODS	Main PD/PK outcome parameters measured were early - and late-phase glucose disposal ( area under the curve of glucose infusion rate [ AUC ( GIR ) ] ) , nonesterified fatty acid concentrations , and IAsp concentrations .\
RESULTS	With increasing proportions of soluble IAsp , the insulin formulations showed significantly higher early metabolic activity ( ratio of AUC ( GIR ) 0-6 h : BIAsp 50/BIAsp 30 = 1.28 [ P < 0.001 ] , BIAsp 70/BIAsp 50 = 1.18 [ P < 0.001 ) , IAsp/BIAsp 70 = 1.15 [ P < 0.01 ] ) and lower late metabolic activity ( ratio of AUC ( GIR ) 12-28 h : BIAsp 50/BIAsp 30 = 0.17 [ P < 0.01 ] , BIAsp 70/BIAsp 50 = 0.21 [ P < 0.05 ] ) .\
RESULTS	Likewise , early IAsp levels were significantly greater and late PK concentrations were significantly lower with increasing proportion of soluble IAsp .\
CONCLUSIONS	There are significant differences between the early and late PD and PK effects among BIAsp 30 , 50 , and 70 and IAsp that should allow tailored treatment with the convenience of prandial and basal insulin in each injection .\
\
###22237884\
BACKGROUND	Prebiotic-containing infant formula may beneficially affect gastrointestinal tolerance and commensal microbiota composition .\
OBJECTIVE	Assess gastrointestinal tolerance and fecal microbiota , pH , and short-chain fatty acid ( SCFA ) concentrations of infants consuming formula with or without prebiotics .\
METHODS	Full-term formula-fed infants were studied to a breastfed comparison group ( BF ) .\
METHODS	Formula-fed infants ( FF ) were randomized to consume a partially hydrolyzed whey formula with ( PRE ) or without ( CON ) 4 g/L of galacto-oligosaccharides and fructo-oligosaccharides ( 9:1 ) .\
METHODS	Fecal bacteria , pH , and SCFA were assessed at baseline , 3 weeks , and 6 weeks .\
METHODS	Caregivers of patients recorded stool characteristics and behavior for 2 days before the 3 - and 6-week visits .\
RESULTS	Feces from infants fed PRE had a higher absolute number ( P = .0083 ) and proportion ( P = .0219 ) of bifidobacteria than CON-fed infants and did not differ from BF .\
RESULTS	BF had a higher proportion of bifidobacteria than CON ( P = .0219 ) and lower number of Clostridium difficile than FF ( P = .0087 ) .\
RESULTS	Feces from formula-fed infants had higher concentrations of acetate ( P < .001 ) , butyrate ( P < .001 ) , propionate ( P < .001 ) , and total SCFAs ( P = .0230 ) than BF ; however , fecal pH was lower ( P = .0161 ) in PRE and BF than CON .\
RESULTS	Prebiotic supplementation did not alter stool patterns , tolerance , or growth .\
RESULTS	BF had more frequent stools that were yellow ( P < .0001 ) and more often liquid than FF ( P < .0001 ) .\
CONCLUSIONS	Infant formula containing the studied oligosaccharides was well tolerated , increased abundance and proportion of bifidobacteria , and reduced fecal pH in healthy infants .\
\
###24078028\
OBJECTIVE	The aim of this study was to demonstrate the safety of using intradermal absorbable sutures for pilonidal sinus skin closure .\
METHODS	The study was prospectively carried out in 203 patients randomized into two groups of patients .\
METHODS	In the first group ( 103 patients ) , interrupted sutures were used ; in the second group ( 100 patients ) , a continuous intradermal suture was used .\
METHODS	We have analyzed the time off work , time to walk without pain , time to sit on the toilet without pain , wound infections , satisfaction rate and esthetic results .\
RESULTS	There were no significant differences between the groups with regard to the time off work , time to walk without pain and time to sit on a toilet without pain .\
RESULTS	There was also no significant difference between the groups with regard to the wound infection rates ( p = 0.64 ) .\
RESULTS	The study suggested that the patients satisfaction was higher when an intradermal suture was used ( p = 0.001 ) .\
RESULTS	Similarly , a better cosmetic appearance of the scar was obtained with an intradermal suture ( p = 0.01 ) .\
CONCLUSIONS	Our results suggest that using intradermal sutures after excision and primary closure of the pilonidal sinus is safe and has advantages in terms of the cosmetic results and patient satisfaction .\
\
###20424500\
BACKGROUND	Patients with medically unexplained or functional somatic symptoms ( FSS ) are prevalent in primary care .\
BACKGROUND	In this pragmatic cluster-randomised controlled trial we aimed to test the effect of a training programme ( The Extended Reattribution and Management model ) for general practitioners ( GPs ) in the treatment of FSS .\
METHODS	38 participating GPs were randomised to the control group or the training group .\
METHODS	The GPs included consecutive 18 - to 65-year-old patients presenting during a 3-week period for new health complaints .\
METHODS	We assessed a stratified subsample with the psychiatric interview Schedules of Clinical Assessment in Neuropsychiatry .\
METHODS	Of 701 patients interviewed , 350 fulfilled the diagnostic criteria for any ICD-10 somatoform disorder ( SD ) and 111 presented FSS without fulfilling these criteria ( sub-threshold SD ) .\
METHODS	Patients completed questionnaires at baseline and after 3 , 12 and 24 months .\
METHODS	The questionnaires included assessment of health status ( 36-item Medical Outcomes Study Short Form ; SF-36 ) , health anxiety ( Whiteley-7 ) and physical symptoms ( Symptom Check List-90 , somatization subscale ) .\
RESULTS	Patients with SD consulting trained GPs improved more on our primary outcome of physical functioning than patients consulting control GPs at the 3-month follow-up ( p = 0.004 ) , but the improvement was not statistically significant at later follow-up .\
RESULTS	We found no significant differences in improvement between patients with SD and those with sub-threshold SD .\
RESULTS	Results for other SF-36 subscales , physical symptoms and health anxiety only showed statistically significant differences between the intervention and control groups for patients with SD ; patients consulting trained GPs had less improvement in vitality , health anxiety and physical symptoms at 24 months compared with the control group .\
CONCLUSIONS	GP training may accelerate improvement in physical functioning for patients with SD .\
CONCLUSIONS	However , the effect is small and may not be clinically significant .\
\
###24557111\
BACKGROUND	We investigated whether individualized positive end-expiratory pressure ( PEEP ) improves oxygenation , ventilation , and lung mechanics during one-lung ventilation compared with standardized PEEP .\
METHODS	Thirty patients undergoing thoracic surgery were randomly allocated to the study or control group .\
METHODS	Both groups received an alveolar recruitment maneuver at the beginning and end of one-lung ventilation .\
METHODS	After the alveolar recruitment maneuver , the control group had their lungs ventilated with a 5 cmH2O PEEP , while the study group had their lungs ventilated with an individualized PEEP level determined by a PEEP decrement trial .\
METHODS	Arterial blood samples , lung mechanics , and volumetric capnography were recorded at multiple timepoints throughout the procedure .\
RESULTS	The individualized PEEP values in study group were higher than the standardized PEEP values ( 10 2 vs 5 cmH2O ; P < 0.001 ) .\
RESULTS	In both groups , arterial oxygenation decreased when bilateral-lung ventilation was switched to one-lung ventilation and increased after the alveolar recruitment maneuver .\
RESULTS	During one-lung ventilation , oxygenation was maintained in the study group but decreased in the control group .\
RESULTS	After one-lung ventilation , arterial oxygenation was significantly higher in the study group ( 306 vs 231 mmHg , P = 0.007 ) .\
RESULTS	Static compliance decreased in both groups when bilateral-lung ventilation was switched to one-lung ventilation .\
RESULTS	Static compliance increased significantly only in the study group ( P < 0.001 ) after the alveolar recruitment maneuver and optimal PEEP adjustment .\
RESULTS	The alveolar recruitment maneuver did not decrease cardiac index in any patient .\
CONCLUSIONS	During one-lung ventilation , the improvements in oxygenation and lung mechanics after an alveolar recruitment maneuver were better preserved by ventilation by using individualized PEEP with a PEEP decrement trial than with a standardized 5 cmH2O of PEEP .\
\
###24007748\
BACKGROUND	Few effective treatments exist for patients with refractory or relapsed and refractory multiple myeloma not responding to treatment with bortezomib and lenalidomide .\
BACKGROUND	Pomalidomide alone has shown limited efficacy in patients with relapsed multiple myeloma , but synergistic effects have been noted when combined with dexamethasone .\
BACKGROUND	We compared the efficacy and safety of pomalidomide plus low-dose dexamethasone with high-dose dexamethasone alone in these patients .\
METHODS	This multicentre , open-label , randomised phase 3 trial was undertaken in Australia , Canada , Europe , Russia , and the USA .\
METHODS	Patients were eligible if they had been diagnosed with refractory or relapsed and refractory multiple myeloma , and had failed at least two previous treatments of bortezomib and lenalidomide .\
METHODS	They were assigned in a 2:1 ratio with a validated interactive voice and internet response system to either 28 day cycles of pomalidomide ( 4 mg/day on days 1-21 , orally ) plus low-dose dexamethasone ( 40 mg/day on days 1 , 8 , 15 , and 22 , orally ) or high-dose dexamethasone ( 40 mg/day on days 1-4 , 9-12 , and 17-20 , orally ) until disease progression or unacceptable toxicity .\
METHODS	Stratification factors were age ( 75 years vs > 75 years ) , disease population ( refractory vs relapsed and refractory vs bortezomib intolerant ) , and number of previous treatments ( two vs more than two ) .\
METHODS	The primary endpoint was progression-free survival ( PFS ) .\
METHODS	Analysis was by intention to treat .\
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01311687 , and with EudraCT , number 2010-019820-30 .\
RESULTS	The accrual for the study has been completed and the analyses are presented .\
RESULTS	302 patients were randomly assigned to receive pomalidomide plus low-dose dexamethasone and 153 high-dose dexamethasone .\
RESULTS	After a median follow-up of 100 months ( IQR 72-132 ) , median PFS with pomalidomide plus low-dose dexamethasone was 40 months ( 95 % CI 36-47 ) versus 19 months ( 19-22 ) with high-dose dexamethasone ( hazard ratio 048 [ 95 % CI 039-060 ] ; p < 00001 ) .\
RESULTS	The most common grade 3-4 haematological adverse events in the pomalidomide plus low-dose dexamethasone and high-dose dexamethasone groups were neutropenia ( 143 [ 48 % ] of 300 vs 24 [ 16 % ] of 150 , respectively ) , anaemia ( 99 [ 33 % ] vs 55 [ 37 % ] , respectively ) , and thrombocytopenia ( 67 [ 22 % ] vs 39 [ 26 % ] , respectively ) .\
RESULTS	Grade 3-4 non-haematological adverse events in the pomalidomide plus low-dose dexamethasone and high-dose dexamethasone groups included pneumonia ( 38 [ 13 % ] vs 12 [ 8 % ] , respectively ) , bone pain ( 21 [ 7 % ] vs seven [ 5 % ] , respectively ) , and fatigue ( 16 [ 5 % ] vs nine [ 6 % ] , respectively ) .\
RESULTS	There were 11 ( 4 % ) treatment-related adverse events leading to death in the pomalidomide plus low-dose dexamethasone group and seven ( 5 % ) in the high-dose dexamethasone group .\
CONCLUSIONS	Pomalidomide plus low-dose dexamethasone , an oral regimen , could be considered a new treatment option in patients with refractory or relapsed and refractory multiple myeloma .\
BACKGROUND	Celgene Corporation .\
\
###18382907\
OBJECTIVE	The primary objective of the present study was to evaluate the effectiveness and adverse events of risedronate use in postmenopausal woman by measuring its effects on urinary crosslinked C-terminal telopeptides of type I collagen ( CTx ) , a biochemical marker of bone resorption .\
METHODS	One hundred osteoporotic ( control and treatment ) and 111 osteopenic ( control and treatment ) postmenopausal women , selected according to World Health Organization criteria , were included in the study .\
METHODS	The treatment groups ( osteopenic and osteoporotic ) were given risedronate 35 mg once a week .\
METHODS	The primary endpoint was mean percentage change in CTx from baseline to 6 months .\
METHODS	The secondary endpoints included evaluation of the incidence of clinical or laboratory adverse events occurring during the 6-month study period .\
METHODS	The least significant change ( LSC ) , calculated from the within-subject variability in the two control groups , was used to define response .\
RESULTS	Of the 211 women enrolled , 157 ( 74.4 % ) completed the study .\
RESULTS	After 6 months , urinary CTx levels were -54.7 % ( range -67 % to -48 % ) below baseline in the osteoporotic treatment group and -66.7 % ( range -74 % to -59 % ) below baseline in the osteopenic treatment group .\
RESULTS	Analysis of LSC showed that 89 % of risedronate treatment groups were categorized as responders after 6 months of treatment .\
CONCLUSIONS	The study shows that osteoporotic and osteopenic women on risedronate treatment have statistically significant suppressed bone turnover and CTx can be useful to confirm this observation .\
CONCLUSIONS	The low withdrawal rate and adverse effects rate show that risedronate was well tolerated by the study population .\
\
###10609041\
OBJECTIVE	To evaluate whether routine pre-intubation positive pressure mask ventilation ( PPMV ) influences the incidence of postoperative nausea and vomiting ( PONV ) .\
METHODS	Prospective , randomised single blinded study .\
METHODS	669 ASA class I-III patients of either sex ( number calculated as follows : incidence of PONV = 30 % , group difference = 25 % , a-error < 5 % , statistical power = 90 % ) scheduled for elective surgery ( no eye , neck , nose or ear surgery ) of at least 30 min duration .\
METHODS	Approval by the local ethical committee and informed written consent was obtained .\
METHODS	After preoxygenation ( 3 min ) and induction of anesthesia with fentanyl ( 1-2 micrograms.kg-1 b.w. ) and thiopental ( 5 mg.kg-1 b.w ) patients were divided into two groups : group 1 patients ( without PPMV , n = 333 ) received succinylcholine 30s after thiopental followed by tracheal intubation .\
METHODS	Group 2 patients ( with PPMV , n = 336 ) were ventilated by mask for at least 30s after thiopental injection , followed by succinylcholine and , after another 120s of PPMV , tracheal intubation .\
METHODS	All anesthetics were performed by 15 anesthesiologists ( 8 certified staff members , 7 residents ) .\
METHODS	Primary endpoint : incidence of PONV during the first 24 h postoperatively .\
METHODS	Secondary end point : relation between PONV and medical qualification of the anesthesiologists .\
OBJECTIVE	significant difference in PONV between groups .\
METHODS	contingency tables with chi-square and Fisher 's exact test , Kruskal-Wallis-test ( for categorical variables ) ; ANOVA with post-hoc Scheffe ( for continuous variables ) , p < 0.05 .\
RESULTS	No difference was found in the incidence of nausea ( 30.6 % vs. 28 % , p = 0.5 ) or vomiting ( 20.1 % vs. 17 % , p = 0.32 ) regardless whether the patients received PPMV or not .\
RESULTS	Women were nearly three times more likely to suffer from PONV ( 35.2 % vs. 13.8 % , p < 0.0001 ) .\
RESULTS	Distribution of age , weight , height , anesthetic duration and surgical procedures were comparable between groups .\
RESULTS	The degree of medical qualification did not influence the incidence of PONV ( p = 0.543 ) .\
CONCLUSIONS	Since neither routine pre-intubation positive pressure mask ventilation nor the medical qualification of the anesthesilogist affect the incidence of PONV neither variable needs to be taken into account in studies concerning PONV .\
\
###25704790\
BACKGROUND	While the addition of targeted therapy to neoadjuvant chemotherapy ( NACT ) dramatically increases the rate of pathological complete response in HER2-positive breast cancer , no reduction in the rate of mastectomy has been observed in randomised studies .\
METHODS	A retrospective single centre analysis of all patients treated with anti HER2-based NACT for T2-4 breast cancer , focusing on patients treated with mastectomy .\
RESULTS	Among 165 patients treated between June 2005 and July 2012 , surgery was performed immediately post-NACT in 152 cases ( 92 % ) .\
RESULTS	Breast-conserving surgery could be performed for 108 of the patients ( 71 % ) , with a 4-year local relapse-free survival of 97 % .\
RESULTS	A mastectomy was performed in two cases following patients ' wishes and in 37 cases based on pre-NACT findings ( n = 18 ) or post-NACT outcomes ( n = 19 ) .\
RESULTS	For 21 out of the 37 cases , a good pathological response was observed , and multidisciplinary reanalysis suggests that breast-conserving surgery outright may have been sufficient for 12 patients .\
RESULTS	Finally , a salvage mastectomy based on post-lumpectomy pathological results was decided in five cases ( 11 % ) .\
RESULTS	The 4-year metastasis-free survival was 84 % for all patients operated on after NACT ( n = 152 ) .\
CONCLUSIONS	Given the good efficacy of anti HER2-based NACT , breast-conserving surgery should be standard practice for most patients .\
CONCLUSIONS	Total mastectomy on the other hand should be restricted to a few patients , mainly those with positive margins on the lumpectomy specimen .\
\
###16157621\
BACKGROUND	There is not univocal concordance for using high-dose sequential therapy ( HDS ) as first-line treatment for aggressive non-Hodgkin 's lymphoma ( NHL ) .\
BACKGROUND	We designed this study to evaluate the usefulness of HDS followed by high-dose therapy ( HDT ) with autologous stem cell transplantation as front-line treatment in different subsets of aggressive NHL .\
METHODS	Among 223 patients aged 15-60 years with aggressive , advanced stage NHL , 106 patients were randomized to VACOP-B ( etoposide , doxorubicin , cyclophosphamide , vincristine , prednisone , bleomycin ) for 12 weeks ( plus HDS/HDT in case of persistent disease ) ( arm A ) , and 117 patients to VACOP-B for 8 weeks plus upfront HDS/HDT ( arm B ) .\
RESULTS	According to the intention-to-treat analysis , the complete response rate was 75 % for arm A and 72.6 % for arm B. With a median follow-up of 62 months there was no difference in 7-year probability of survival ( 60 % and 57.8 % ; P = 0.5 ) , disease-free survival ( DFS ) ( 62 % and 71 % ; P = 0.2 ) and progression-free survival ( PFS ) ( 44.9 % and 40.9 % ; P = 0.7 ) between the two arms .\
RESULTS	Subgroup analyses confirmed that the best results in terms of survival , DFS and PFS were achieved by patients with large B-cell NHL without bone marrow ( BM ) involvement , independently of the treatment arm .\
RESULTS	Results were poorer in other categories of patients and poorest in patients with BM involvement .\
CONCLUSIONS	Aggressive NHL patients do not benefit from upfront HDS/HDT .\
\
###18431264\
OBJECTIVE	Ischemia-reperfusion injury is an important cause of renal dysfunction after abdominal aortic aneurysm repair .\
OBJECTIVE	Human atrial natriuretic peptide ( hANP ) is a potent endogenous natriuretic , diuretic , and vasorelaxant peptide .\
OBJECTIVE	The objective of the present study was to evaluate the effects of hANP on renal function in patients undergoing abdominal aortic aneurysm repair .\
METHODS	A prospective , randomized , placebo-controlled study\
METHODS	Intensive care unit of a university hospital .\
METHODS	Forty patients undergoing elective abdominal aortic aneurysm repair .\
METHODS	The patients were randomized to receive a continuous infusion of either hANP ( 0.01-0 .05 microg/kg/min ) ( n = 20 ) or placebo ( n = 20 ) immediately before aortic cross-clamping .\
METHODS	The infusion of hANP or placebo continued for 48 hrs .\
RESULTS	Blood and urine samples were taken before surgery , at admission to the intensive care unit , and on days 1 , 2 , and 3 postoperatively , for measurement of serum concentrations of sodium , creatinine , and blood urea nitrogen and plasma concentrations of ANP and brain natriuretic peptide ( BNP ) .\
RESULTS	Urine volume and urinary concentrations of N-acetyl-beta-D-glucosaminidase ( NAG ) , sodium , and creatinine were also measured .\
RESULTS	The mean plasma concentration of ANP was significantly higher in the hANP group than in the placebo group .\
RESULTS	The mean plasma BNP concentration was significantly lower in the hANP group than in the placebo group .\
RESULTS	The mean serum concentrations of creatinine and blood urea nitrogen were significantly ( p < .05 ) lower in the hANP group than in the placebo group .\
RESULTS	The mean urine volume and mean creatinine clearance were significantly ( p < .05 ) higher in the hANP group than in the placebo group .\
RESULTS	The mean urinary NAG/creatinine ratio was significantly ( p < .05 ) lower in the hANP group than in the placebo group .\
CONCLUSIONS	The intraoperative and postoperative infusion of low-dose hANP preserved renal function in patients undergoing abdominal aortic aneurysm repair .\
CONCLUSIONS	Further studies are needed to assess the efficacy of prophylactic hANP infusion on perioperative renal outcome .\
\
###8459060\
OBJECTIVE	Theophylline has been shown to delay the onset of myocardial ischemia and to prolong exercise duration .\
OBJECTIVE	The present study was done to evaluate the mechanisms and actions of intravenous theophylline on the onset of ischemia and exercise duration .\
BACKGROUND	The ischemic threshold may be altered by the differential coronary vasodilation induced by endogenous adenosine .\
BACKGROUND	Theophylline is a competitive receptor antagonist of adenosine and may have a potential as an anti-ischemic medication .\
METHODS	A double-blind , placebo-controlled crossover trial using an infusion of intravenous theophylline ( 8.0 + / - 2.0 mg/liter ) or placebo before exercise in 12 patients was done .\
METHODS	Oxygen uptake , heart rate , blood pressure and heart rate-blood pressure product were determined at the onset of > or = 0.1-mV ST segment depression and angina pectoris , as well as at peak exercise .\
METHODS	The extent of myocardial ischemia was evaluated by electrocardiographic criteria and quantitation of thallium-201 images at peak exercise .\
RESULTS	When compared with placebo , theophylline significantly delayed time to the onset of exercise-induced ischemia .\
RESULTS	Ischemia occurred at a higher heart rate-blood pressure product and oxygen uptake .\
RESULTS	Exercise duration was prolonged but was not associated with greater ischemia , as determined by oxygen uptake , ST segment depression , angina pectoris and size of thallium-201 defect .\
CONCLUSIONS	It is concluded that theophylline favorably alters myocardial ischemia not only by delaying its onset but also by enabling it to occur at a higher threshold without causing deleterious effects during exercise .\
CONCLUSIONS	The mechanism for the increased ischemic threshold may be through the inhibition of adenosine and the coronary steal phenomenon .\
\
###9704681\
BACKGROUND	Angiotensin-converting enzyme inhibitors are used in patients who have myocardial infarction with left ventricular ( LV ) dysfunction .\
BACKGROUND	Few data are available in patients whose LV function is within the normal range .\
RESULTS	The Fosinopril in Acute Myocardial Infarction Study was a 2-year , randomized , double-blind , placebo-controlled , multicenter study of 285 patients with anterior acute myocardial infarction and was designed to investigate the effects of the early ( < 9 hours ) administration of fosinopril and thrombolysis on ( 1 ) changes in echocardiographically evaluated LV volumes at 3 months and ( 2 ) long-term occurrence of death and congestive heart failure .\
RESULTS	LV volumes were normal at baseline in more than 70 % of patients and were comparable between groups both at baseline and after 3 months of treatment .\
RESULTS	Fosinopril-treated patients showed a 30 % reduction in the 2-year combined prevalence of death or moderate-to-severe congestive heart failure ( New York Heart Association class III-IV ) despite having a worse clinical profile at baseline .\
RESULTS	The benefit of fosinopril was confirmed both in patients without congestive heart failure at admission and in those with ejection fraction > 40 % at baseline .\
RESULTS	Moreover , the incidence of significant ventricular arrhythmias was lower in the fosinopril group ( 0.8 % vs 6.0 % , p < 0.02 ) .\
CONCLUSIONS	The results of the Fosinopril in Acute Myocardial Infarction Study suggest that early treatment with fosinopril can benefit patients with acute myocardial infarction in addition to a prevention of LV remodeling .\
\
###8707022\
BACKGROUND	Atrial fibrillation is a relatively frequent atrial arrhythmias activated with increased morbidity and mortality .\
METHODS	To assess the propafenone and sotalol efficacy in the prevention of paroxysmal atrial fibrillation ( FA ) we enrolled , in a double blind placebo controlled study over 1 year , 300 patients ( 168 males ) ; mean age 52.3 + / - 17.2 years , randomized to receive orally , three times daily , either propafenone ( mean daily dose of 13 + / - 1.5 mg/Kg ; Group A : 102 patients ) or sotalol ( mean daily dose of 3 + / - 0.4 mg/Kg ; Group B : 106 patients ) or placebo ( Group C : 92 patients ) .\
METHODS	All subjects experienced in previous 12 months at least 4 FA episodes .\
METHODS	During follow-up we considered atrial tachyarrhythmia ( TAA ) onset : FA recurrences and/or the onset of atrial flutter ( FIA ) .\
METHODS	Three patients ( 3 % ) of Group A and 5 ( 5 % ) of Group B interrupted therapy for side effects ; 5 patients ( 5.5 % ) of Group C with supraventricular tachycardia interrupted the double blind therapy ; 11 were lost to follow-up .\
RESULTS	Of the remaining 276 patients , TAA were observed in 43 ( 44.8 % ) of 96 patients in Group A , 28 ( 29.5 % ) of 95 patients in Group B and 62 ( 72.9 % ) of 85 patients in Group C. TAA were significantly less in A and B groups than in Group C ( p < 0.005 ) ; a significant TAA reduction was also observed in patients treated with sotalol compared with those treated with propafenone ( p < 0.05 ) .\
RESULTS	TAA were : FA-118 ( 88.7 % ) and FIA-15 ( 11.3 % ) .\
RESULTS	The arrhythmia free time was significantly shorter in Group C.\
CONCLUSIONS	Sotalol seems to be more effective than propafenone and therefore represents a valid alternative for FA prevention .\
\
###20203546\
OBJECTIVE	This study was designed to compare the effectiveness of remifentanil vs. a lidocaine-esmolol combination in blunting the hemodynamic response to laryngoscopy and intubation during rapid sequence induction using thiopental and rocuronium in normotensive patients .\
METHODS	Sixty-six patients with American Society of Anesthesiologists ( ASA ) physical status class I who required tracheal intubation for elective surgery were randomly assigned to one of two groups .\
METHODS	Group R received 0.9 % saline 10 ml and remifentanil 1 microg/kg .\
METHODS	Group LE received lidocaine 1.5 mg/kg and esmolol 1.0 mg/kg .\
METHODS	Anesthesia was induced with thiopental sodium 5 mg/kg , followed by rocuronium 1.0 mg/kg .\
METHODS	Mean arterial pressure and heart rate were recorded at baseline , after induction , immediately after intubation and every minute for five minutes after intubation .\
RESULTS	Changes in mean arterial pressure over time between the two groups were significantly different ( P < 0.0001 ) .\
RESULTS	The maximum pressor response was observed immediately after intubation , at which time the mean arterial pressure change from baseline in group LE ( 29.7 % ) ( 95 % confidence interval [ CI ] : 116.1 , 121.9 ) was higher than that in group R ( 4.4 % ) ( 95 % CI : 92.9 , 98.5 ) ( P < 0.0001 ) .\
RESULTS	Two patients in group R and 15 patients in group LE developed hypertension ( odds ratio [ OR ] : 0.064 ) ( P < 0.001 ) .\
RESULTS	Changes in heart rate over time between the two groups were not significantly different ( P = 0.465 ) .\
CONCLUSIONS	The results of this study show that remifentanil 1 mg/kg is more effective than the combination of lidocaine 1.5 mg/kg and esmolol 1 mg/kg for attenuating the hemodynamic responses to rapid sequence intubation .\
\
###23146549\
BACKGROUND	Postpartum weight retention is a risk factor for long-term weight gain .\
BACKGROUND	Encouraging new mothers to consume a healthy diet may result in weight loss .\
OBJECTIVE	To assess predictors of diet quality during the early postpartum period ; to determine whether diet quality , energy intake , and lactation status predicted weight change from 5 to 15 months postpartum ; and to determine whether an intervention improved diet quality , reduced energy intake , and achieved greater weight loss compared with usual care .\
METHODS	Randomized clinical trial ( KAN-DO : Kids and Adults Now-Defeat Obesity ) , a family - and home-based , 10-month , behavioral intervention to prevent childhood obesity , with secondary aims to improve diet and physical activity habits of mothers to promote postpartum weight loss .\
METHODS	Overweight/obese , postpartum women ( n = 400 ) , recruited from 14 counties in the Piedmont region of North Carolina .\
METHODS	Eight education kits , each mailed monthly ; motivational counseling ; and one group class .\
METHODS	Anthropometric measurements and 24-hour dietary recalls collected at baseline ( approximately 5 months postpartum ) and follow-up ( approximately 10 months later ) .\
METHODS	Diet quality was determined using the Healthy Eating Index-2005 ( HEI-2005 ) .\
METHODS	Descriptive statistics , ( 2 ) , analysis of variance , bi - and multivariate analyses were used .\
RESULTS	At baseline , mothers consumed a low-quality diet ( HEI-2005 score = 64.4 11.4 ) .\
RESULTS	Breastfeeding and income were positive , significant predictors of diet quality , whereas body mass index was a negative predictor .\
RESULTS	Diet quality did not predict weight change .\
RESULTS	However , total energy intake , not working outside of the home , and breastfeeding duration/intensity were negative predictors of weight loss .\
RESULTS	There were no significant differences in changes in diet quality , decreases in energy intake , or weight loss between the intervention ( 2.3 5.4 kg ) and control ( 1.5 4.7 kg ) arms .\
CONCLUSIONS	The family-based intervention did not promote postpartum weight loss .\
CONCLUSIONS	Reducing energy intake , rather than improving diet quality , should be the focus of weight-loss interventions for overweight/obese postpartum women .\
\
###10894284\
OBJECTIVE	To assess the role of resistance mutations in subjects experiencing virological failure on zidovudine ( ZDV ) and lamivudine ( 3TC ) combined with a protease inhibitor ( PI ) to those failing on ZDV/3TC alone .\
METHODS	Samples were obtained from previously antiretroviral therapy-naive subjects enrolled into two studies , AVANTI 2 and AVANTI 3 .\
METHODS	Subjects were randomized to receive either : ZDV/3TC or ZDV/3TC plus indinavir ( IDV ) for 52 weeks ( AVANTI 2 ) , and ZDV/3TC or ZDV/3TC and nelfinavir ( NFV ) for 28 weeks ( AVANTI 3 ) .\
METHODS	Emergence of viral resistance mutations was monitored by population sequencing and phenotypic resistance was determined by the recombinant virus assay .\
RESULTS	Genotypic data were obtained for subjects with plasma HIV-1 RNA > 400 copies/ml .\
RESULTS	In AVANTI 2 , ZDV mutations were detected in 27 % of ZDV/3TC-treated patients at week 52 , but were absent in subjects treated with ZDV/3TC/IDV .\
RESULTS	No subjects from either arm of AVANTI 3 developed ZDV resistance mutations at week 28 .\
RESULTS	The M184V mutation developed in most ZDV/3TC-treated subjects from both studies .\
RESULTS	The presence of M184V was , however , associated with significantly lower plasma viral RNA levels when compared with values obtained before initiation of treatment .\
RESULTS	There was a high frequency ( 4 of 11 ) of the protease L10F substitution in ZDV/3TC/IDV-treated patients that was associated with virological failure but did not result in phenotypic resistance to any of the PIs tested .\
CONCLUSIONS	ZDV mutations were not detected in ZDV/3TC/PI-treated patients and they developed slowly in those treated with ZDV/3TC .\
CONCLUSIONS	Few protease mutations known to confer phenotypic PI resistance developed in the ZDV/3TC/PI arms of either study .\
CONCLUSIONS	The low prevalence of ZDV and PI mutations is encouraging regarding the future treatment options of these patients .\
\
###19183227\
OBJECTIVE	To evaluate the efficacy and safety of lacosamide ( 200 and 400 mg/day ) when added to one to three concomitant antiepileptic drugs ( AEDs ) in patients with uncontrolled partial-onset seizures .\
METHODS	This multicenter , double-blind , placebo-controlled trial randomized patients ( age 16-70 years ) with partial-onset seizures with or without secondary generalization to placebo , lacosamide 200 , or lacosamide 400 mg/day .\
METHODS	The trial consisted of an 8-week baseline , a 4-week titration , and a 12-week maintenance period .\
RESULTS	Four hundred eighty-five patients were randomized and received trial medication .\
RESULTS	Among these , 87 % were taking two or more concomitant AEDs .\
RESULTS	Median percent reduction in seizure frequency per 28 days from baseline to maintenance period ( intent-to-treat , ITT ) was 20.5 % for placebo , 35.3 % for lacosamide 200 mg/day ( p = 0.02 ) , and 36.4 % for 400 mg/day ( p = 0.03 ) .\
RESULTS	In the per protocol population , the reductions were 35.3 % for lacosamide 200 mg/day ( p = 0.04 ) and 44.9 % for 400 mg/day ( p = 0.01 ) compared to placebo ( 25.4 % ) .\
RESULTS	The 50 % responder rate for lacosamide 400 mg/day ( 40.5 % ) was significant ( p = 0.01 ) over placebo ( 25.8 % ) , but was not for 200 mg/day ( 35.0 % ) .\
RESULTS	In the per protocol population , the 50 % responder rate for lacosamide 400 mg/day ( 46.3 % ) was significant ( p < 0.01 ) compared with the placebo responder rate ( 27.5 % ) .\
RESULTS	Dose-related adverse events ( AEs ) included dizziness , nausea , and vomiting .\
RESULTS	Clinically relevant changes in the mean plasma concentrations of commonly used AEDs were not observed .\
CONCLUSIONS	Results of this trial demonstrated the efficacy and tolerability of adjunctive lacosamide 200 and 400 mg/day and support that lacosamide may be an advantageous option for the treatment of partial-onset seizures in patients with epilepsy .\
\
###12799892\
BACKGROUND	Since the first laparoscopic cholecystectomy ( LC ) was reported in 1990 , it has met with widespread acceptance as a standard procedure using four trocars .\
BACKGROUND	The fourth ( lateral ) trocar is used to grasp the fundus of the gallbladder so as to expose Calot 's triangle .\
BACKGROUND	It has been argued that the fourth trocar is not necessary in most cases .\
BACKGROUND	Therefore , the aim of this study was to compare the three-port vs the four-port technique .\
METHODS	Between 1998 and 2000 , 200 consecutive patients undergoing elective LC for gallstone disease were randomized to be treated via either the three - or four-port technique .\
RESULTS	There was no difference between the two groups in age , sex , or weight .\
RESULTS	In terms of outcome , there was no difference between the two groups in success rate , operating time , number of oral analgesic tablets ( paracetamol ) , visual analogue score , or postoperative hospital stay ; however , the three-port group required fewer analgesic injections ( nalbuphine ) ( 0.4 vs 0.77 , p = 0.024 ) .\
CONCLUSIONS	The three-port technique is as safe as the standard four-port one for LC .\
CONCLUSIONS	The main advantages of the three-port technique are that it causes less pain , is less expensive , and leaves fewer scars .\
\
###20634797\
BACKGROUND	Angiotensin-converting enzyme ( ACE ) inhibitors differ in their lipophilic/hydrophilic index that determines their tissue bioavailability and affinity to ACE , which may result in major differences in the degree of blockade of cardiac ACE .\
BACKGROUND	We evaluated the hypothesis that in patients with chronic heart failure ( CHF ) and activated cardiac renin-angiotensin-aldosterone system ( RAAS ) , lipophilic ACE inhibitors with high affinity for ACE ( perindopril and quinapril ) will cause marked blockade of cardiac angiotensin ( Ang ) II and aldosterone generation , but not a hydrophilic ACE inhibitor with low affinity for ACE ( lisinopril ) .\
METHODS	Patients were randomized to receive perindopril ( 8 mg/day ) , quinapril ( 40 mg/day ) , or lisinopril ( 20 mg/day ) for 3-4 weeks before cardiac catheterization .\
METHODS	The coronary sinus-aortic root gradients for Ang I and II , and aldosterone were determined .\
RESULTS	A total of 19 patients completed the study .\
RESULTS	Compared to a healthy control group , all three ACE inhibitors decreased circulating Ang II and aldosterone to a similar extent .\
RESULTS	There were only minor differences between the three ACE inhibitors for the Ang II gradient between the coronary sinus and aortic root .\
RESULTS	The gradient for aldosterone tended to be positive in the quinapril group and absent/negative in the lisinopril and perindopril groups .\
RESULTS	Despite the lowest pulmonary capillary wedge pressure ( PCWP ) , gradients between the coronary sinus and aortic root for Ang II and aldosterone were actually the highest in the quinapril group .\
CONCLUSIONS	These findings do not support the concept that a hydrophilic ACE inhibitor is less effective in blocking the cardiac RAAS as compared to lipophilic ACE inhibitors .\
\
###8919987\
BACKGROUND	The aim of the study is to determine what concentration of ketorolac and morphine administered together i.v. achieve best synergic effect between NSAID antiinflammatory and opioids analgesic properties .\
METHODS	Randomized comparative study was carried out on 180 patients , ASA II-IV , undergoing major general surgery , in an University Clinic .\
METHODS	Postoperative pain therapy by i.v. PCA : group 1 morphine 0.75 mg.ml + ketorolac 0.75 mg.ml ; group 2 morphine 0.50 mg.ml + ketorolac 1.50 mg.ml ; group 3 morphine 0.25 mg.ml + ketorolac 1.50 mg.ml ; in saline solution .\
METHODS	Initial bolus : 2 ml .\
METHODS	Continuous infusion 1.5 ml.h .\
METHODS	Demand bolus : 0.2 ml .\
METHODS	Lockout time : 30 minutes .\
METHODS	Evaluations included : pain intensity ( T0 , T3 , T18 ) ; total amount of infused drugs ( T18 ) ; number of valid demands and attempts ( T18 ) ; amount of autoadministered analgesic drugs in percent of highest available amount ( T18 ) ; side effects ( T18 ) ; patient 's judgment .\
METHODS	ANOVA and Student 's `` t '' - test .\
RESULTS	A statistically significant reduction of pain intensity was found after 3 and 18 hours in the three groups , no differences were found among the groups .\
RESULTS	Group 2 required an amount of autoadministered drugs significantly lower than other groups .\
RESULTS	Rare side effects .\
RESULTS	Patient 's judgment was generally positive .\
CONCLUSIONS	Results suggest a greater synergetic effect between morphine and ketorolac in concentrations used in group 2 .\
\
###21495914\
OBJECTIVE	This pilot study measured activities of daily living ( ADLs ) in users propelling both a standard dual handrim Action 3 wheelchair and a standard Action 3 wheelchair with a Neater Uni-Wheelchair ( NUW ) kit attachment .\
OBJECTIVE	The kit consists of a steerable front castor and a single pushrim propelling both rear wheels via a differential .\
OBJECTIVE	There would be a difference in the efficiency of ADL skill performance , speed and heart rate .\
METHODS	Twenty non-disabled participants simulating hemiplegia were used in a cross over , repeated measures trial .\
METHODS	Assessment of Motor and Process Skills ( AMPS ) of users undertaking making a bed and laying a table ` Swedish style ' , tasks , were measured .\
METHODS	Heart rate at rest and post-task and time taken to complete each task were recorded .\
RESULTS	Heart rate when laying the table was lower in the NUW ( p < 0.005 ) and task completion time was quicker ( p < 0.0001 ) .\
RESULTS	There was no difference in motor and process ability skills .\
CONCLUSIONS	ADL tasks in the NUW were completed more efficiently with no loss in quality of motor and process skills performance .\
CONCLUSIONS	This suggests that the NUW is a viable alternative to current one arm drive provision .\
\
###14756388\
OBJECTIVE	A new , ready-to-use solution for injection of paracetamol ( Perfalgan 10 mg/ml ) without previous reconstitution has been developed .\
OBJECTIVE	The aim of the study was to determine the serum concentration profiles of paracetamol after 15 min infusion of Perfalgan 0.5 g and 1 g doses and to demonstrate the bioequivalence between Perfalgan 1 g dose and a marketed reference formulation for injection , propacetamol 2 g ( Pro-Dafalgan 2 g ) equivalent to 1 g of paracetamol .\
OBJECTIVE	The secondary objective was to evaluate local tolerance , and clinical and biological safety .\
METHODS	The study was performed in 24 healthy , male volunteers , according to an open-label , randomized , single-dose , 3-period crossover design , with a 1-week washout period between the doses .\
METHODS	Blood samples were taken prior to each administration and at 18 time points within the 24-hour period following the beginning of each infusion .\
METHODS	Serum concentrations of paracetamol were determined by validated high-performance liquid chromatography with UV detection .\
METHODS	From serum concentration-time data , a non-compartmental pharmacokinetic analysis was performed to calculate Cmax , tmax , AUC ( inf ) , t ( 1/2 ) , MRT , Cl ( T ) and Vd .\
METHODS	Log-transformed AUC ( inf ) and Cmax were tested for bioequivalence .\
METHODS	The local pain intensity at infusion site was assessed using a 4-point categorical scale from 0 ( none ) to 3 ( severe ) .\
METHODS	The clinical and biological safety was evaluated by physical examination with measurements of vital signs and ECG and laboratory tests including hematology and biochemistry .\
RESULTS	After infusion of 0.5 g and I g of the new paracetamol solution , C ( max ) and AUC ( inf ) increased proportionally with dosage .\
RESULTS	After dose correction to 1 g of paracetamol , the mean ( + / - SD ) Cmax ratio was 0.98 + / - 0.24 and 0.94 + / - 0.08 for AUC ratio .\
RESULTS	Identical t ( max ) was observed for the 2 paracetamol dosages and 90 % confidence intervals for t ( 1/2 ) , MRT , Cl ( T ) and V ( d ) were within the acceptable interval 0.8-1 .25 .\
RESULTS	The calculated 90 % confidence intervals of the new solution ( Perfalgan 1 g ) to marketed solution ( propacetamol 2 g ) ratios were 1.11-1 .31 ( point estimate 1.20 ) for C ( max ) and 1.10-1 .16 ( point estimate 1.13 ) for AUC ( inf ) .\
RESULTS	These values were within the acceptable bioequivalence intervals of 0.75 to 1.33 for Cmax and 0.80-1 .25 for AUC ( inf ) .\
RESULTS	Application site disorders were the most frequently observed adverse events but local pain at infusion site was less reported by subjects after Perfalgan ( 2 % ) compared to propacetamol ( 20 % ) .\
RESULTS	The clinical and biological safety was good and equivalent for the 3 treatments .\
CONCLUSIONS	After administration of paracetamol solution for injection 0.5 g and 1 g , the pharmacokinetics of paracetamol is linear .\
CONCLUSIONS	All results indicate that 1 g of paracetamol administered as Perfalgan 10 mg/ml is bioequivalent to propacetamol 2 g with a better local safety .\
\
###24373555\
BACKGROUND	Nonalcoholic fatty liver disease ( NAFLD ) is one of the commonest liver disorders .\
BACKGROUND	Obesity , insulin resistance , lipid peroxidation and oxidative stress have been identified amongst the possible hits leading to the onset and progression of this disease .\
BACKGROUND	Nutritional evaluation of NAFLD patients showed a lower-than-recommended intake of vitamin E. Vitamin E is a family of 8 isoforms , 4 tocopherols and 4 tocotrienols .\
BACKGROUND	Alpha-tocopherol has been widely investigated in liver diseases , whereas no previous clinical trial has investigated tocotrienols for NAFLD .\
BACKGROUND	Aim of the study was to determine the effects of mixed tocotrienols , in normalising the hepatic echogenic response in hypercholesterolaemic patients with ultrasound-proven NAFLD .\
METHODS	Eighty-seven untreated hypercholesterolaemic adults with ultrasound-proven NAFLD were enrolled and randomised into control group ( n = 44 ) and tocotrienols group ( n = 43 ) .\
METHODS	The treatment , either mixed tocotrienols 200 mg twice daily or placebo , had a 1-year duration.Normalisation of hepatic echogenic response , being the trial primary aim , was used in sample size calculations .\
METHODS	The data were assessed according to intention to treat principle as primary outcome .\
METHODS	Per protocol analysis was also carried out as secondary outcome measurement .\
RESULTS	Thirty and 34 participants concluded the study in the tocotrienols and placebo group respectively .\
RESULTS	Alpha-tocopherol levels were within the normal range for all subjects .\
RESULTS	As primary outcome , the normalisation of hepatic echogenic response was significantly higher for the tocotrienols treated group compared to the placebo group in the intention to treat analysis ( P = 0.039 ; 95 % CI = 0.896-6 .488 ) .\
RESULTS	As secondary objective , the per protocol assessment also showed significant rate of remission ( P = 0.014 ; 95 % CI = 1.117-9 .456 ) .\
RESULTS	Worsening of NAFLD grade was recorded in two patients in the placebo group , but none in the group treated with tocotrienols .\
RESULTS	No adverse events were reported for both groups .\
CONCLUSIONS	This is the first clinical trial that showed the hepatoprotective effects of mixed palm tocotrienols in hypercholesterolemic adults with NAFLD .\
\
###19121921\
OBJECTIVE	Nutrition is known to influence the immune system and can thereby modulate resistance to infection .\
OBJECTIVE	The objective of this clinical trial was to assess the influence of a cascade-fermented food consisting of fruits , nuts , and vegetables rich in polyphenols ( Regulat ) on the immune system in healthy volunteers .\
METHODS	The clinical trial was double-blinded and placebo-controlled .\
METHODS	In total , 48 healthy men 20-48 y of age with a body mass index of 20-28 kg/m ( 2 ) were enrolled in the clinical trial .\
METHODS	The group was characterized according to lifestyle parameters and only men with regular low to moderate intake of fruit and vegetables were enrolled .\
METHODS	The intervention lasted for a period of 4 wk .\
METHODS	Volunteers received Regulat twice daily or a placebo product ( essence of vinegar ) .\
RESULTS	The intake of Regulat significantly enhanced intracellular glutathione content in lymphocytes ( P < 0.05 ) , monocytes ( P < 0.05 ) , and natural killer cells ( P < 0.01 ) .\
RESULTS	Furthermore , activation of natural killer cell cytotoxicity in response to interleukin-2 stimulation ( P < 0.05 ) , a reduction of total lipid peroxidation , and a reduction of soluble vascular cell adhesion molecule-1 ( P < 0.01 ) and soluble intercellular adhesion molecule-1 ( P < 0.05 ) as inflammatory blood markers were found in the Regulat but not in the placebo group .\
CONCLUSIONS	In summary , the results from this intervention study demonstrate promising physiologic effects of immune regulation on the innate immune system and antioxidative and anti-inflammatory parameters after Regulat supplementation .\
CONCLUSIONS	However , these promising results need to be confirmed in more volunteers with a more prolonged application to ensure significant beneficial effects of Regulat in the general population .\
\
###22043677\
OBJECTIVE	To observe the effect of moxibustion at Sanyinjiao ( SP 6 ) on delivery stage of primipara .\
METHODS	Sixty cases of primipara were divided into a moxibustion at Sanyinjiao group , a non-acupoint group and a blank group .\
METHODS	When the diameter of wormb mouth opened to 2-3 cm , showing that it entered into active stage of uterine contraction , moxibustion at Sanyinjiao ( SP 6 ) for primipara was applied in moxibustion at Sanyinjiao group ; moxibustion was applied at 1 cun towards radialis from the region where 2 cun above Kongzui ( LU 6 ) in non-acupoint group , 30 minutes treatment was for both groups .\
METHODS	There was no intervention in blank group .\
METHODS	After delivery , the time of first , second and third delivery stages and postpartum bleeding 2 hours after delivery were compared among three groups .\
RESULTS	The active duration of first delivery stage in moxibustion at Sanyinjiao group was significantly shorter than that in the other two groups ( P < 0.05 , P < 0.01 ) ; the duration of the second delivery stage in moxibustion at Sanyinjiao group was significantly shorter than that in the other two groups ( both P < 0.05 ) as well ; the postpartum bleeding 2 hours after delivery in moxibustion at Sanyinjiao group was less than other two groups and the difference was statistic significant between moxibustion at Sanyinjiao group and blank group ( P < 0.05 ) .\
CONCLUSIONS	By moxibustion at Sanyinjiao ( SP 6 ) , the active duration of first delivery stage and the duration of second delivery stage are markedly shortened , postpartum bleeding 2 hours after delivery is obviously reduced , and the safety of vaginal delivery is increased .\
\
###18000777\
OBJECTIVE	To investigate the potential benefits of postoperative nutrition in malnourished patients with gastrointestinal cancer .\
METHODS	A total of 646 malnourished patients with gastrointestinal cancer defined by the subjective global assessment ( SGA ) were randomly divided into parenteral nutrition group ( n = 215 ) , enteral nutrition group ( n = 215 ) and conventional group ( n = 216 ) .\
METHODS	Two nutritional regimens were designed to be isocaloric 125.5 kJ ( 30 kcal ) .\
METHODS	kg ( -1 ) .\
METHODS	d ( -1 ) and isonitrogenous 0.25 g.kg ( -1 ) .\
METHODS	d ( -1 ) for 7 postoperative days .\
METHODS	Conventional group did not receive artificial nutrition before and after surgery .\
METHODS	Postoperative complications , mortality and postoperative length of hospital stay were compared .\
RESULTS	All baseline and surgical characteristics were comparable among 3 groups .\
RESULTS	Overall postoperative mortality was 1.5 % , and no difference was observed among 3 groups .\
RESULTS	Postoperative complications occurred in 61 ( 28.4 % ) patients in enteral nutrition group , 72 ( 33.5 % ) in parenteral nutrition group , and 97 ( 44.9 % ) in conventional group ( P = 0.000 vs enteral nutrition group ; P = 0.001 vs parenteral nutrition group ) .\
RESULTS	Postoperative length of hospital stay was ( 9.8 + / -3.4 ) d in enteral nutrition group , ( 11.2 + / -5.0 ) d in parenteral nutrition group , and ( 14.5 + / -7.1 ) d in conventional group ( P = 0.001 vs enteral nutrition group ; P = 0.003 vs parenteral nutrition group ) .\
CONCLUSIONS	Postoperative artificial nutrition support is beneficial to the malnourished patients with gastrointestinal cancer , which improves postoperative outcome .\
CONCLUSIONS	Early enteral nutrition significantly reduces the infectious complication rate and length of postoperative hospital stay as compared with parenteral nutrition .\
\
###16808776\
BACKGROUND	Many low-risk patients with pneumonia are hospitalized despite recommendations to treat such patients in the outpatient setting .\
OBJECTIVE	To identify the factors associated with the hospitalization of low-risk patients with pneumonia .\
METHODS	We analyzed data collected by retrospective chart review for 1,889 low-risk patients ( Pneumonia Severity Index [ PSI ] risk classes I to III without evidence of arterial oxygen desaturation ) enrolled in a cluster-randomized trial conducted in 32 emergency departments .\
RESULTS	Overall , 845 ( 44.7 % ) of all low-risk patients were treated as inpatients .\
RESULTS	Factors independently associated with an increased odds of hospitalization included PSI risk classes II and III , the presence of medical or psychosocial contraindications to outpatient treatment , comorbid conditions that were not contained in the PSI ( cognitive impairment , history of coronary artery disease , diabetes mellitus , or pulmonary disease ) , multilobar radiographic infiltrates , and home therapy with oxygen , corticosteroids , or antibiotics before presentation .\
RESULTS	While 32.8 % of low-risk inpatients had a contraindication to outpatient treatment and 47.1 % had one or more preexisting treatments , comorbid conditions , or radiographic abnormalities not contained in the PSI , 20.1 % had no identifiable risk factors for hospitalization other than PSI risk class II or III .\
CONCLUSIONS	Hospital admission appears justified for one-third of low-risk inpatients based upon the presence of one or more contraindications to outpatient treatment .\
CONCLUSIONS	At least one-fifth of low-risk inpatients did not have a contraindication to outpatient treatment or an identifiable risk factor for hospitalization , suggesting that treatment of a larger proportion of such low-risk patients in the outpatient setting could be achieved without adversely affecting patient outcomes .\
\
###24091567\
BACKGROUND	VTE is the proximate cause of 100,000 deaths in the United States each year .\
BACKGROUND	Perioperative VTE risk among surgical patients varies by 20-fold , which highlights the importance of risk stratification to identify high-risk patients , in whom chemoprophylaxis can decrease VTE risk , and low-risk patients , for whom the risk-benefit relationship of prophylaxis may be unfavorable .\
METHODS	We used data from a statewide surgical quality collaborative for surgical procedures performed between 2010 and 2012 .\
METHODS	Regression-based techniques identified predictors of 90-day VTE while adjusting for procedural complexity and comorbid conditions .\
METHODS	A weighted risk index was created and was validated subsequently in a separate , independent dataset .\
RESULTS	Data were available for 10,344 patients , who were allocated randomly to a derivation or validation cohort .\
RESULTS	The 90-day VTE rate was 1.4 % ; 66.2 % of the derivation cohort and 65.5 % of the validation cohort received chemoprophylaxis .\
RESULTS	Seven risk factors were incorporated into a weighted risk index : personal history of VTE , current cancer , sepsis/septic shock/systemic inflammatory response syndrome , age60 years , BMI40 kg/m2 , male sex , and family history of VTE .\
RESULTS	Prediction for 90-day VTE was similar in the derivation and validation cohorts ( areas under the receiver operator curve , 0.72 and 0.70 , respectively ) .\
RESULTS	An 18-fold variation in 90-day VTE rate was identified .\
CONCLUSIONS	A weighted risk index quantifies 90-day VTE risk among surgical patients and identifies an 18-fold variation in VTE risk among the overall surgical population .\
\
###25304132\
OBJECTIVE	Interleukin-13 ( IL-13 ) has been implicated as a key driver of UC .\
OBJECTIVE	This trial evaluates the efficacy and safety of tralokinumab , an IL-13-neutralising antibody , as add-on therapy in adults with moderate-to-severe UC despite standard treatments .\
METHODS	Non-hospitalised adults with UC ( total Mayo score 6 ) were randomised to receive tralokinumab 300mg or placebo subcutaneously every 2weeks for 12weeks .\
METHODS	The primary end point was the rate of clinical response at week 8 .\
METHODS	Secondary efficacy end points included clinical remission and mucosal healing rates at week 8 and changes in total Mayo score , total modified Riley score , partial Mayo score and disease activity markers .\
RESULTS	Clinical response rate was 38 % ( 21/56 ) for tralokinumab vs. 33 % ( 18/55 ) for placebo ( p = 0.406 ) .\
RESULTS	Clinical remission rate was 18 % ( 10/56 ) vs. 6 % ( 3/55 ) ( p = 0.033 ) and mucosal healing rate was 32 % ( 18/56 ) vs. 20 % ( 11/55 ) ( p = 0.104 ) for tralokinumab vs placebo .\
RESULTS	Changes to week 8 in total Mayo score and total modified Riley score were similar for tralokinumab and placebo ( least-squares mean difference between groups : -0.49 ( p = 0.394 ) and 0.25 ( p = 0.449 ) , respectively ) .\
RESULTS	Partial Mayo score at week 4 was lower with tralokinumab than placebo ( least-squares mean difference between groups : -0.90 ( p = 0.041 ) ) .\
RESULTS	No consistent patterns were observed for disease activity markers .\
RESULTS	Tralokinumab had an acceptable safety profile .\
CONCLUSIONS	Add-on therapy with tralokinumab did not significantly improve clinical response .\
CONCLUSIONS	However , the higher clinical remission rate with tralokinumab than placebo suggests that tralokinumab may benefit some patients with UC .\
CONCLUSIONS	Tralokinumab was well tolerated .\
BACKGROUND	ClinicalTrials.gov number : NCT01482884 .\
\
###16202291\
OBJECTIVE	To determine the clinical manifestations of vulvovaginal candidiasis ( VVC ) and to study the mycologic eradication rate of different miconazole treatment courses for VVC .\
METHODS	Three hundred cases of VVC were recruited .\
METHODS	The Candidas were cultured .\
METHODS	A prospective and randomized study was performed to compare the treatment effect of 3 day miconazole ( 400 mg/d ) , 6 day miconazole ( 400 mg/d ) , and 7 day miconazole ( 200 mg/d ) for uncomplicated and complicated VVC .\
RESULTS	Among 300 cases of VVC , uncomplicated , complicated and recurrent VVC were 56.0 % , 44.0 % and 9.7 % ( 29/300 ) respectively .\
RESULTS	C. albicans was isolated most frequently 90.3 % ( 271/300 ) , followed by C. glabrata ( 7.3 % ) , C. tropicalis ( 1.3 % ) , C. krusei ( 0.7 % ) , and C. parapsilosis ( 0.3 % ) .\
RESULTS	Mycologic eradication rate of 3 day , 6 day and 7 day miconazole courses for uncomplicated VVC at day 14 was 96.0 % , 93.5 % and 98.0 % , respectively ( P > 0.05 ) .\
RESULTS	Eradication rate of 3 day , 6 day and 7 day miconazole courses for complicated VVC at day 14 was 86.7 % , 92.5 % , and 86.4 % , respectively ( P > 0.05 ) .\
RESULTS	Eradication rate of 3 day , 6 day and 7 day miconazole courses for uncomplicated VVC at day 35 was 93.8 % , 95.3 % , and 89.8 % , respectively ( P > 0.05 ) .\
RESULTS	Eradication rate of 3 day , 6 day and 7 day miconazole courses for complicated VVC at day 35 was 89.7 % , 97.3 % and 86.8 % , respectively ( P > 0.05 ) .\
CONCLUSIONS	Treatment of VVC should be individualized , and women with complicated VVC achieve superior mycologic eradication by a 6 day miconazole course .\
\
###16634952\
OBJECTIVE	The purpose of this study was to assess whether identification of subjects with different susceptibility to plaque-induced gingival inflammation is dependent on the length of time of de novo plaque accumulation .\
METHODS	Retrospective analysis of data obtained from a recently reported randomized split-mouth localized experimental gingivitis trial involving 96 healthy non-smokers .\
METHODS	Gingival and plaque index , gingival crevicular fluid volume ( GCF ) , angulated bleeding score , and the derived parameter cumulative plaque exposure ( CPE ) were recorded at days 0 , 7 , 14 , and 21 .\
METHODS	The primary outcome variable to express severity of inflammation was GCF and each subject was a statistical unit .\
METHODS	Based on subject distribution of GCF-day 21 residuals after standardization for CPE-day 21 , two sub-populations ( upper and lower distribution quartiles ) were selected .\
METHODS	They were , respectively , defined as `` high responders '' ( HR ) ( n = 24 ) and `` low responders '' ( LR ) ( n = 24 ) and characterized by significantly different severity of gingivitis to similar amounts of plaque deposits .\
METHODS	The same analysis was repeated at days 7 and 14 .\
METHODS	Prevalence of HR and LR was compared between days using the chi ( 2 ) [ ML ] test .\
RESULTS	For both day 7 and day 14 , the quartile distribution of LR and HR was statistically significant ( p = 0.02 ) .\
RESULTS	Fifty percent of LR and 71 % of HR presented a consistent level of susceptibility to plaque-induced gingival inflammation even after only 7 and/or 14 days of plaque accumulation .\
CONCLUSIONS	These findings support the concept that the subject-based susceptibility to plaque-induced gingival inflammation is an individual trait , only partly related to the length of time of exposure to plaque .\
\
###24472342\
BACKGROUND	Endoscopic mucosal resection ( EMR ) is simple and quick and has low complication rates .\
BACKGROUND	However , the disadvantage of local recurrence or remnant rate limits the use of this technique .\
BACKGROUND	We aimed to analyse the outcomes of conventional EMR and EMR with circumferential incision ( CIEMR ) , a simplified modification of EMR , in the endoscopic treatment of rectal carcinoid tumours .\
METHODS	A total of 59 consecutive patients with rectal carcinoid tumours without regional lymph node enlargement confirmed by endoscopic ultrasonography were included in the study .\
METHODS	These patients underwent endoscopic treatment from January 2009 to September 2011 and were randomly designated into CIEMR ( n = 31 ) or EMR group ( n = 28 ) .\
METHODS	En bloc resection rate , pathological complete resection rate , procedure time , complications and follow-up outcomes were analysed .\
RESULTS	The en bloc resection rate was not significantly different between the CIEMR and EMR groups ( 100 % versus 96.55 % , P > 0.05 ) .\
RESULTS	The pathological complete resection rate was higher in the CIEMR group than in the EMR group ( 96.7 % versus 82.14 % , P < 0.05 ) .\
RESULTS	The overall complication rate , delayed bleeding and procedure time were not significantly different between the two groups .\
RESULTS	No recurrence was observed in either the EMR or CIEMR group .\
CONCLUSIONS	CIEMR optimises the procedure of EMR and simplifies the technique of endoscopic submucosal dissection ; thus , it has a better histologically complete resection rate and more acceptable complication rate than EMR .\
CONCLUSIONS	Thus , CIEMR may be preferable to conventional EMR for resection of rectal carcinoid tumours less than 15 mm .\
\
###16825962\
OBJECTIVE	To compare the rate of Acute Respiratory Distress Syndrome ( ARDS ) in multiply injured patients with femoral shaft fractures , treated with intramedullary femoral nails inserted with or without reaming .\
METHODS	Prospective , randomized , multicenter , clinical trial .\
METHODS	Seven Level 1 trauma centers .\
METHODS	Three hundred fifteen patients with 322 femoral shaft fractures were stratified into 2 groups according to their estimated injury severity scores ( ISS > or = 18 vs. ISS < 18 ) and then randomized to receive an IM nail with either reamed or unreamed insertion for primary stabilization of their femoral shaft fracture .\
METHODS	One hundred forty seven patients with 151 fractures received an unreamed nail whereas 168 patients with 171 fractures , received a reamed nail .\
METHODS	All fractures were nailed within 24 hours after their trauma .\
METHODS	Closed intramedullary nailing for femoral shaft fractures .\
METHODS	Determination of the rate of ARDS in patients undergoing intramedullary nailing of femoral shaft fractures .\
RESULTS	Three of the 63 multiply injured patients who received a reamed nail developed ARDS as compared with 2 out of 46 patients in the unreamed group .\
RESULTS	This difference was not statistically significant ( P = 0.42 ) .\
RESULTS	( The power for this difference is only 5 % .\
RESULTS	39,817 patients are needed in each group to detect a difference that small . )\
RESULTS	This difference was not statistically significant .\
RESULTS	There were a total of 4 deaths , 2 each in both the reamed and unreamed group .\
RESULTS	No death resulted from ARDS .\
CONCLUSIONS	The overall incidence of ARDS was found to be low with primary stabilization of femoral shaft fractures with intramedullary nailing .\
CONCLUSIONS	There was no difference in the incidence of ARDS between the reamed and unreamed groups , given the sample size .\
\
###17301299\
BACKGROUND	Universal vaccination of children 6 to 59 months of age with trivalent inactivated influenza vaccine has recently been recommended by U.S. advisory bodies .\
BACKGROUND	To evaluate alternative vaccine approaches , we compared the safety and efficacy of intranasally administered live attenuated influenza vaccine with those of inactivated vaccine in infants and young children .\
METHODS	Children 6 to 59 months of age , without a recent episode of wheezing illness or severe asthma , were randomly assigned in a 1:1 ratio to receive either cold-adapted trivalent live attenuated influenza vaccine ( a refrigeration-stable formulation of live attenuated intranasally administered influenza vaccine ) or trivalent inactivated vaccine in a double-blind manner .\
METHODS	Influenza-like illness was monitored with cultures throughout the 2004-2005 influenza season .\
RESULTS	Safety data were available for 8352 children , and 7852 children completed the study according to the protocol .\
RESULTS	There were 54.9 % fewer cases of cultured-confirmed influenza in the group that received live attenuated vaccine than in the group that received inactivated vaccine ( 153 vs. 338 cases , P < 0.001 ) .\
RESULTS	The superior efficacy of live attenuated vaccine , as compared with inactivated vaccine , was observed for both antigenically well-matched and drifted viruses .\
RESULTS	Among previously unvaccinated children , wheezing within 42 days after the administration of dose 1 was more common with live attenuated vaccine than with inactivated vaccine , primarily among children 6 to 11 months of age ; in this age group , 12 more episodes of wheezing were noted within 42 days after receipt of dose 1 among recipients of live attenuated vaccine ( 3.8 % ) than among recipients of inactivated vaccine ( 2.1 % , P = 0.076 ) .\
RESULTS	Rates of hospitalization for any cause during the 180 days after vaccination were higher among the recipients of live attenuated vaccine who were 6 to 11 months of age ( 6.1 % ) than among the recipients of inactivated vaccine in this age group ( 2.6 % , P = 0.002 ) .\
CONCLUSIONS	Among young children , live attenuated vaccine had significantly better efficacy than inactivated vaccine .\
CONCLUSIONS	An evaluation of the risks and benefits indicates that live attenuated vaccine should be a highly effective , safe vaccine for children 12 to 59 months of age who do not have a history of asthma or wheezing .\
CONCLUSIONS	( ClinicalTrials.gov number , NCT00128167 [ ClinicalTrials.gov ] . )\
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###22799753\
BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) has become a major public health problem worldwide because of its high and increasing prevalence , morbidity , and mortality .\
BACKGROUND	Little attention has been paid to earlier stages of COPD or before it has developed .\
BACKGROUND	Reportedly , TCM may have some advantages in relieving symptoms and reducing the incidence of COPD exacerbations .\
BACKGROUND	We postulate that patients with COPD will benefit from therapy with TCM treatment according to syndrome differentiation .\
METHODS	A prospective , multi-center , double-blinded and randomized controlled method will be used to test the therapeutic effects of TCM treatment according to syndrome differentiation .\
METHODS	A total of 504 patients will be enrolled into this study with 252 in each treatment group .\
METHODS	Patients will receive medication according to their assigned group .\
METHODS	TCM for COPD will be administered twice daily over 52 weeks , and all patients will follow the treatment program for 52 weeks .\
METHODS	The FEV ( 1 ) and exacerbations will be used as the primary outcome measures .\
METHODS	The quality of life and the Modified Medical Research Council ( MMRC ) Dyspnea Scale , and the 6-min walk test ( 6MWD ) will be used as the secondary outcome measures .\
CONCLUSIONS	We postulate that patients with COPD will benefit from therapy with TCM treatment according to syndrome differentiation .\
BACKGROUND	This study is registered at ClinicalTrials.gov , NCT01486186 .\
\
###18973027\
OBJECTIVE	To explore the clinical curative effect of Gancao Fuzi Decoction in treating osteoarthritis of knee joint and to analyze its mechanism on how to relieve the symptoms and signs of the disease .\
METHODS	100 cases were randomly divided into treatment group with orally taken Gancao Fuzi Decoction and control group with orally taken Votalin sustained released tablets .\
METHODS	Then the symptoms and signs of the disease were classified , and a table to record observations was designed .\
METHODS	Two weeks later , statistical treatment was carried out basing on the observation and points in the table .\
METHODS	And then the study drew comparisons before and after the treatment as well as between the two groups .\
METHODS	Other evaluations were carried out among the patients with osteoarthritis of knee joint , including reactive protein C , blood sedimentation rate , interleukin-I , arthralgia , tendernese of joints , joint function , integrated therapy , adverse effects etc. .\
RESULTS	The total effective rate of the control and treated group were 88 % and 92 % , respectively .\
RESULTS	The symptoms , the physical sign score and the index of the laboratory had predominance statistical significant ( P < 0.01 ) between the prior and after treatment and the latter was better , the effects of both groups were equal and had no statistical significance .\
RESULTS	The changes of the C-reactive protein and blood sedimentation in the control group were better than in the treated group .\
CONCLUSIONS	Gancao Fuzi Decoction has the function of war-ming yang , expelling wind , eliminating dampness , removing swelling , relieving pain and improving joints indeed when treating osteoarthritis of knee joint .\
\
###25040643\
OBJECTIVE	To assess nurse-midwife provision of early medical termination of pregnancy ( TOP ) in a high-resource setting where ultrasound examination for dating of pregnancy is part of the protocol .\
METHODS	Randomised controlled equivalence trial .\
METHODS	Out-patient family planning unit at a university hospital .\
METHODS	Women seeking early medical TOP .\
METHODS	A total of 1180 women were randomised , without any prior examination , to counselling , examination , and treatment by either nurse-midwife or gynaecologist .\
METHODS	Ultrasound was performed in all cases by the allocated provider .\
METHODS	The primary outcome was efficacy , defined as the successful completion of TOP without need for vacuum aspiration .\
METHODS	Secondary outcomes were safety , defined as need for hospitalisation or blood transfusion , and acceptability , defined as preferred provider were the women to have a medical TOP in the future .\
RESULTS	A total of 481 women in the nurse-midwife group and 457 women in the doctor group were available for the final analysis .\
RESULTS	The effectiveness of provision of medical TOP by nurse-midwife providers was superior to that provided by doctors ( risk difference 1.6 % , 95 % confidence interval 0.2-3 .0 % , which was within the set margin of equivalence ) .\
RESULTS	There were no significant differences in safety parameters .\
RESULTS	Women examined and counselled by a nurse-midwife were significantly more likely ( P < 0.001 , 95 % confidence interval 0.308-0 .394 ) to prefer seeing a nurse-midwife for the consultation were they to have another medical TOP in the future .\
CONCLUSIONS	These findings show that nurse-midwife provision of early medical TOP in a high-resource setting , where ultrasound is part of the protocol , is effective , and can be safely implemented with high acceptability among women .\
\
###23414496\
OBJECTIVE	Contingency management ( CM ) interventions are efficacious in treating cocaine abusing methadone patients , but few studies have examined the effect of age on treatment outcomes in this population .\
OBJECTIVE	This study evaluated the impact of age on treatment outcomes in cocaine abusing methadone patients .\
METHODS	Data were analyzed from 189 patients enrolled in one of three randomized studies that evaluated the efficacy of CM versus standard care ( SC ) treatment .\
RESULTS	Age was associated with some demographics and drug use characteristics including racial composition , education , and methadone dose .\
RESULTS	Primary drug abuse treatment outcomes did not vary across age groups , but CM had a greater benefit for engendering longer durations of abstinence in the middle/older and older age groups compared to the younger age groups .\
RESULTS	At the 6-month follow-up , submission of a cocaine positive urine sample was predicted by submission of a cocaine positive sample at intake , higher methadone doses , and assignment to SC rather than CM treatment .\
CONCLUSIONS	As substance abusers are living longer , examination of the efficacy of pharmacological and psychosocial treatments specifically within older age groups may lead to a better understanding of subpopulations for whom enhanced treatments such as CM are warranted .\
\
###25487930\
OBJECTIVE	The aim of this study was to investigate clinical application of remifentanil in local anesthesia for resection of tumors in functional brain area .\
METHODS	Twenty-four patients were randomly divided into two groups : control group and remifentanil group .\
METHODS	In remifentanil group remifentanil was infused intravenously with micro pump in 0.05-0 .1 gkg-1min-1 .\
METHODS	The hemodynamic changes and complications during operation were monitored .\
RESULTS	The satisfactory degree for surgical procedure was evaluated .\
RESULTS	The surgery of two groups could be completed in a conscious state .\
RESULTS	Mean artery pressure ( MAP ) , heart rate ( HR ) in remifentanil group during opening or closing skull or intra - cranial period were significantly lower than control group ( p < 0.05 ) .\
RESULTS	There were no conspicuous complications in two groups such as respiratory depression , nausea , vomitting and dysphoria .\
RESULTS	Satisfaction rate of remifentanyl group was significantly higher than control group ( p < 0.05 ) .\
CONCLUSIONS	Awake brain tumor surgery could be completed in rational use of remifentanil on the base of good local anesthesia , and hemodynamics were stable and the patients were well tolerated .\
\
###23335153\
BACKGROUND	Palliative care is expected to incorporate comprehensive support for family caregivers given that many caregivers suffer psychological morbidity .\
BACKGROUND	However , systematically implemented evidence-based psychological support initiatives are lacking .\
OBJECTIVE	The objective of this study was to prepare caregivers for the role of supporting a patient with advanced cancer receiving home-based palliative care by offering a one-to-one psycho-educational intervention .\
OBJECTIVE	We hypothesised that primary family caregivers who participated in the intervention would report decreased psychological distress ( primary outcome ) , fewer unmet needs and increased levels of perceived preparedness , competence and positive emotions .\
METHODS	A three-arm randomised controlled trial was conducted comparing two versions of the intervention ( one face-to-face visit versus two visits ) plus standard care to a control group ( standard care ) across four sites in Australia .\
RESULTS	A total of 298 participants were recruited ; 148 were in the Control condition , 57 in Intervention 1 ( one visit ) and 93 in Intervention 2 ( two visits ) .\
RESULTS	Relative to participants in the control group ; the psychological well-being of participants in the intervention condition was improved by a small amount but non-significantly .\
RESULTS	No significant reduction in unmet needs or improvements in positive aspects of caregiving amongst the intervention group were identified .\
RESULTS	However , the intervention demonstrated significant improvements in participants ' levels of preparedness and competence for Intervention 2 .\
CONCLUSIONS	This research adds to accumulating body of evidence demonstrating that relatively short psycho-educational interventions can enable family caregivers to feel more prepared and competent in the role of supporting a dying relative .\
CONCLUSIONS	Further investigation is required to determine the longer term outcomes of such interventions .\
\
###12900820\
BACKGROUND	Multiple risk-factor interventions that include lifestyle changes have been proved to be effective in reducing risk profile in persons at high risk for developing coronary heart disease ( CHD ) .\
BACKGROUND	There have not been similar studies involving transplant recipients .\
BACKGROUND	The purpose of this study is to examine effects of exercise training on cardiovascular risk profile during the first year after renal transplantation .\
BACKGROUND	We used traditional CHD risk factors and the Framingham CHD prediction methods .\
METHODS	Ninety-six transplant recipients were randomly assigned to 2 groups at 1 month posttransplantation : the exercise training ( EX group ; n = 51 ) and usual care groups ( UC group ; n = 45 ) .\
METHODS	Testing was performed at baseline and 12 months posttransplantation and included maximal exercise testing and evaluation of CHD risk factors and risk-factor categories , determined by means of the Framingham equations .\
RESULTS	Overall 10-year CHD risk score did not change in either group .\
RESULTS	All patients showed increases in total cholesterol ( TC ) level , high-density lipoprotein fraction of cholesterol ( HDL-C ) , and body mass index over time .\
RESULTS	No differences were observed between groups , except for a trend toward greater improvement in HDL cholesterol levels in the EX group ( P = 0.07 ) .\
RESULTS	Significantly more patients in the EX group moved out of the high-risk category in TC-HDL ratio .\
RESULTS	All patients remained in the high-risk category for physical fitness .\
RESULTS	There was a significant negative correlation of CHD risk and maximal exercise capacity ( r = -0.406 ; P < 0.001 ) .\
CONCLUSIONS	Exercise training alone does not reduce CHD risk during the first year after transplantation .\
CONCLUSIONS	Research to determine the effects of multiple risk interventions during a longer period in transplant recipients is warranted .\
\
###22635965\
OBJECTIVE	Haemodilution resulting from crystalloid priming of the cardiopulmonary bypass circuit represents a major risk factor for blood transfusions in high-risk cardiac surgery patients .\
OBJECTIVE	We designed this study to evaluate the effects of antegrade autologous priming ( AAP ) on reducing perioperative blood transfusion and markers of the inflammatory response in older patients ( > 75 years ) .\
METHODS	Seventy-two patients undergoing first-time coronary bypass and/or aortic valve replacement were prospectively randomised to a cardiopulmonary bypass ( CPB ) with or without AAP .\
METHODS	AAP was performed by adding the patient 's own blood to the prime solution ( mean 280 ml ) .\
METHODS	Perfusion and anaesthetic techniques were as usual .\
METHODS	The haematocrit was maintained at a minimum of 21 % during CPB .\
METHODS	Patients were well matched for all preoperative variables , including established transfusion risk factors .\
METHODS	The primary endpoint was the requirement of red cell transfusion .\
METHODS	The surrogate endpoints were renal function , inflammatory response and ischaemic parameters .\
METHODS	Blood samples were drawn pre - and intraoperatively and at intervals of 6 hours till POD 6 .\
RESULTS	Current analysis shows no differences in patients receiving homologous packed red cell transfusions .\
RESULTS	Also , markers of the inflammatory response ( IL6 , IL8 ) , renal function ( cystatin C , creatinine ) and myocardial ischaemia ( troponin T , CK-MB ) were comparable in both groups ( p > 0.05 ) .\
RESULTS	Clinical outcomes were similar with respect to pulmonary , renal and hepatic function , length of ICU stay and hospital stay .\
CONCLUSIONS	These data suggest that antegrade autologous priming is a safe procedure , but an ineffective way for improving biocompatibility and reducing the need for blood transfusion in older patients .\
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###21254007\
BACKGROUND	Radiofrequency ablation ( RFA ) is a relatively new treatment for hypersplenism .\
BACKGROUND	The results of a randomized clinical trial comparing RFA and splenectomy with 5 years of follow-up are reported .\
METHODS	Fifty-seven patients with hypersplenism due to liver cirrhosis were assigned randomly ( in a 1 : 2 ratio ) to splenectomy ( 19 patients ) or RFA ( 38 ) .\
METHODS	The RFA group was subdivided according to the percentage of the spleen ablated : less than 50 per cent ( 9 patients ) , 50-70 per cent ( 18 ) or over 70 per cent ( 11 ) .\
METHODS	Routine blood tests were performed before and after operation , and total spleen volume and ablated volume were measured by contrast-enhanced computed tomography .\
METHODS	The primary endpoint of the trial was recurrence of hypersplenism , assessed as platelet and white cell counts , at 5 years after surgery .\
RESULTS	White cell and platelet counts increased rapidly after intervention in both groups .\
RESULTS	By 36 months after operation peripheral platelet and white cell counts had decreased significantly in the RFA group compared with the splenectomy group , and declined to baseline levels by 48 months .\
RESULTS	Hypersplenism recurred after 6 months in patients with less than 50 per cent of the spleen ablated .\
RESULTS	Blood cell count in the splenectomy group and in patients with more than 50 per cent of the spleen ablated decreased with time after operation , but to levels that remained significantly higher than those before operation ( P < 0050 ) .\
RESULTS	Splenic volume reached its nadir 12 months after RFA and then increased with time .\
CONCLUSIONS	Splenic RFA represents an attractive alternative treatment for hypersplenism induced by liver cirrhosis , particularly when more than 50 per cent of the spleen is ablated .\
\
###16192259\
OBJECTIVE	To compare the use of meal replacements or medication during weight maintenance subsequent to weight loss using a very low-energy diet ( VLED ) in overweight or obese adults .\
METHODS	Participants followed a liquid VLED of 2177 kJ for 12 weeks followed by 4 weeks of re-orientation to solid foods .\
METHODS	Participants were randomized at week 16 to receive either meal replacements or Orlistat both combined with a structured meal plan containing an energy value calculated to maintain weight loss .\
METHODS	Sixty-four women ( age = 49.9 + / - 10 y , weight = 101.6 + / - 17.1 kg , height = 164.9 + / - 6.0 cm , BMI = 36.7 + / - 5.4 kg/m ( 2 ) ) and 28 men ( age = 53.7 + / - 9.6 y , weight = 121.8 + / - 16.0 kg , height = 178.7 + / - 5.6 cm , BMI = 37.8 + / - 4.9 kg/m ( 2 ) ) completed a 1 year weight management program .\
METHODS	Behavioral weight management clinics included topics on lifestyle , physical activity ( PA ) , and nutrition .\
METHODS	Participants met for 90 min weekly for 26 weeks , and then biweekly for the remaining 26 weeks .\
RESULTS	Minutes of PA , fruits and vegetables ( FV ) , and pedometer steps were recorded on a daily basis and reported at each group meeting .\
RESULTS	Body weight was obtained at each group meeting .\
RESULTS	During VLED , the MR group decreased body weight by 22.8 + / - 6.1 kg and the Orlistat group decreased body weight by 22.3 + / - 6.1 kg .\
RESULTS	During weight maintenance , there was no significant group by time interaction for body weight , PA , FV consumption , or pedometer steps .\
RESULTS	At week 16 , the meal replacement group had a body weight of 85.4 + / - 14.3 kg that increased to 88.1 + / - 16.5 kg at 52 weeks ( p < 0.05 ) .\
RESULTS	At week 16 , the Orlistat group had a body weight of 85.7 + / - 17.9 kg that increased to 88.5 + / - 20.3 kg at 52 weeks ( p < 0.05 ) .\
CONCLUSIONS	Subsequent to weight loss from a VLED , meal replacements and Orlistat treatments were both effective in maintaining weight significantly below baseline levels over a 52 week period of time .\
CONCLUSIONS	Meal replacements may be a viable alternative strategy to medications for weight maintenance .\
\
###16841666\
OBJECTIVE	To observe the effect of multi-glycosides of tripterygii ( MT ) on latent autoimmune diabetes of adults ( LADA ) in early stage .\
METHODS	The diabetic patients were divided randomly into the control group treated with insulin alone and the treated group treated with insulin and MT. Levels of insulin , C-peptide , glutamic acid decarboxylase antibody ( GADAb ) and islet cell antibody ( ICA ) were detected and clinical features of the disease were observed .\
RESULTS	There was no difference between the control group and the treated group in body mass index ( BMI ) , the occurrence of diabetic keto-acidosis and the function of liver and kidney ( P > 0.05 ) .\
RESULTS	After 6 months ' treatment , the positive rate of GADAb and ICA decreased , plasma levels of fasting and 2 hrs post-prandial C-peptide and also 2 hrs post-prandial true insulin in the treated group increased ( P < 0.01 ) , while all the above indexes improved more significantly after 1 year 's treatment ( P < 0.01 ) .\
CONCLUSIONS	Compared treatment of insulin with multi-glycosides of tripterygii in early stage of LADA has better effects in relieving autoimmune injury and recovering function of pancreatic island than insulin alone .\
\
###23657668\
OBJECTIVE	The purpose of this study was to determine whether treatment outcomes vary according to the design of the mandibular repositioning appliance ( MRA ) .\
OBJECTIVE	Two titratable MRA 's were compared .\
OBJECTIVE	The designs differ in advancement hardware and configuration of acrylic both in bulk and interocclusal contact .\
METHODS	The primary treatment outcome was the Respiratory Disturbance Index ( RDI ) .\
METHODS	Other outcomes that were compared included Sleep Apnea Quality of Life Index ( SAQLI ) , Epworth Sleepiness Scale , oxygen saturation , and subjective feedback regarding experiences with the appliances .\
METHODS	Twenty-four subjects were recruited from consecutive referrals for MRA therapy following diagnosis of obstructive sleep apnea ( OSA ) by polysomnography .\
METHODS	Subjects were randomly assigned to a treatment arm of the crossover study .\
METHODS	Each subject underwent an initial sleep study with a type III home monitor to establish a baseline RDI .\
METHODS	Subjects were then treated with one of the two MRAs determined by random assignment .\
METHODS	The MRA self-titration phase was monitored until a treatment position was determined , and the home sleep study was repeated .\
METHODS	After a 2-week period without any OSA treatment , subjects received the second MRA and the self-titration treatment protocol was repeated .\
METHODS	At completion of treatment with each appliance , subjects answered questionnaires and underwent a sleep study with the type III monitor .\
METHODS	The outcome data for each appliance were compared using analysis of variance .\
RESULTS	Eighteen subjects completed the treatment protocol .\
RESULTS	There were no significant statistical differences in treatment outcomes between the two appliances .\
RESULTS	There was a statistically significant ( p 0.05 ) preference for a MRA design with minimal coverage of teeth and palate .\
RESULTS	The subjects ' appliance selection was consistent with a corresponding reduction in SAQLI score for the selected appliance .\
CONCLUSIONS	Although no statistically significant difference was observed between the two appliances in the outcomes measured , there was a trend toward greater improvement with the appliance with less acrylic resin bulk and less interocclusal contact .\
CONCLUSIONS	MRA selection should favor titratable , unobtrusive designs with appropriate construction to promote acceptance and adherence to MRA therapy .\
\
###18647298\
OBJECTIVE	To compare , in a post hoc analysis of a phase III trial , the maximum recommended doses of fesoterodine ( 8 mg ) and tolterodine ( 4 mg ) for improving overactive bladder ( OAB ) symptoms and health-related quality of life ( HRQoL ) , as fesoterodine effectively reduces OAB symptoms vs placebo .\
METHODS	Eligible patients with frequency ( > or = eight voids/24 h ) and either urgency ( > or = six episodes over 3 days ) or urgency urinary incontinence ( UUI ; > or = three episodes over 3 days ) were randomized to placebo , fesoterodine 4 or 8 mg , or tolterodine extended-release ( ER ) 4 mg for 12 weeks ; fesoterodine 4 mg data were published elsewhere .\
METHODS	Patients completed a 3-day bladder diary in which they recorded the time of each void , voided volume ( VV ) , and the severity of urgency .\
METHODS	A post hoc inferential analysis was conducted on the primary endpoint ( voids/24 h ) , the two co-primary endpoints ( UUI episodes/24 h and treatment response ) , several secondary endpoints ( severe urgency plus UUI per 24 h , mean VV ( MVV ) / void , and continent days/week ) , HRQoL , using the King 's Health Questionnaire ( KHQ ) and the International Consultation on Incontinence Questionnaire-Short Form ( ICIQ-SF ) , and self-reported bladder-related problems .\
METHODS	A subanalysis also assessed all endpoints for patients who were incontinent at baseline .\
METHODS	Tolerability and safety were assessed by evaluating adverse events , residual urine volume , laboratory variables and treatment withdrawals .\
RESULTS	By week 12 , patients with OAB in both active-treatment groups showed significant improvements in most bladder diary variables and treatment response rates compared with placebo .\
RESULTS	Fesoterodine 8 mg was statistically significantly better than tolterodine ER 4 mg for improving UUI episodes , severe urgency plus UUI , mean VV , and number of continent days/week .\
RESULTS	In addition , the fesoterodine and tolterodine ER groups showed significantly greater improvements in HRQoL than the placebo group , with positive changes in most domains of the KHQ and an improvement in ICIQ-SF score .\
RESULTS	The fesoterodine 8-mg group had statistically significant improvements over placebo in eight of nine KHQ domains .\
RESULTS	A major improvement in the severity of bladder-related problems was reported by 39 % of the fesoterodine 8 mg and 34 % of the tolterodine ER groups vs 25 % of those on placebo ( P < or = 0.01 ) .\
RESULTS	Results for the subgroup of incontinent patients at baseline were similar to the overall results .\
RESULTS	Adverse events reported most commonly with active treatment included dry mouth , constipation , dry eye , dry throat , and nausea .\
CONCLUSIONS	Both fesoterodine and tolterodine ER significantly improved OAB symptoms and HRQoL , with statistically significant advantages for fesoterodine 8 mg compared with tolterodine ER on several important endpoints .\
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###11535769\
OBJECTIVE	To evaluate the effectiveness of intraarterial lidocaine in controlling pain after uterine artery embolization ( UAE ) .\
METHODS	In this double-blind prospective study , patients undergoing UAE received preservative-free 1 % lidocaine or saline solution ( control ) in the uterine arteries before embolization .\
METHODS	Postprocedural pain was managed with patient-controlled intravenous morphine .\
METHODS	Attempted doses , number of doses received , total morphine dose , and maximum pain numeric rating scale ( NRS ) score during the postprocedural hospitalization were recorded and compared .\
METHODS	Three-month follow-up magnetic resonance ( MR ) imaging and symptomatic questionnaires were collected and compared .\
RESULTS	Ten patients received lidocaine and eight patients received placebo .\
RESULTS	Moderate to severe vasospasm was noted in seven patients after lidocaine injection , whereas no vasospasm was noted in the placebo group ( P = .004 ) .\
RESULTS	Patients in the lidocaine group had lower NRS pain scores than those in the placebo group ( P = .012 ) , whereas there was no difference in morphine requirement between treated patients and control subjects .\
RESULTS	The study was terminated after 18 patients were treated as a result of unexpected vasospasm .\
CONCLUSIONS	Intraarterial 1 % lidocaine is associated with moderate to severe vasospasm .\
CONCLUSIONS	Lidocaine significantly lowers subjective pain , but there is no difference in analgesic requirements .\
CONCLUSIONS	The routine use of intraarterial lidocaine is not recommended for pain control until the long-term effects of vasospasm on outcome is known .\
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###9563071\
OBJECTIVE	To evaluate mechanistically the effect of food on the absorption and gastrointestinal transit of the protease inhibitor saquinavir .\
METHODS	Pharmacoscintigraphic investigation in eight healthy volunteers .\
RESULTS	Gastric emptying occurred rapidly in the fasted state with some capsules leaving the stomach prior to disintegration .\
RESULTS	Unmeasurable plasma concentrations were observed in several subjects when dosed under fasted conditions .\
RESULTS	Following post-prandial administration the radioactive marker became re-distributed within the stomach contents and consequently slower gastric emptying resulted .\
RESULTS	Plasma concentrations under fed conditions were measurable up to 12 hrs after administration in seven of the eight subjects .\
RESULTS	Six of the eight plasma profiles showed secondary peaks at c. 4 hours post-dose ; two of which coincided with the gastrocolonic response following ingestion of lunch .\
CONCLUSIONS	Bioavailability of saquinavir is significantly improved in the presence of food .\
CONCLUSIONS	Emptying of intact capsules in the fasted state may further reduce bioavailability .\
CONCLUSIONS	In the fed state , capsules disintegrate rapidly and gastric emptying is prolonged which may improve exposure of the drug to target absorption sites .\
CONCLUSIONS	Saquinavir may be absorbed from the colon .\
CONCLUSIONS	Second peaks in the absorption profile can only be attributed to gastrocolonic response following ingestion of a meal in some cases .\
CONCLUSIONS	Increased absorption is more likely to be due to an increase in dissolved drug being available for absorption due to general increased motility and secretion stimulated by ingestion of a meal .\
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###9347429\
OBJECTIVE	To evaluate the quality of pain control achieved with continuous local anesthetic infusion via a femoral nerve catheter , and to determine the optimum concentration of bupivacaine necessary to maintain pain control after full surgical anesthesia is established with 0.5 % bupivacaine .\
METHODS	Randomized , prospective study .\
METHODS	Tertiary care teaching center .\
METHODS	25 ASA physical status I and II patients scheduled to undergo arthroscopically-aided anterior cruciate ligament ( ACL ) reconstruction by one surgeon , and who were willing to accept a femoral nerve catheter for postoperative pain control .\
METHODS	All patients received general anesthesia with propofol/alfentanil ( 10 ml/1 ml ) mixture and nitrous oxide/oxygen ( 60 % / 40 % ) mixture via endotracheal tube .\
METHODS	After induction of general anesthesia , a femoral nerve catheter was inserted with the aid of a nerve stimulator , and 20 ml of 0.5 % bupivacaine was administered .\
METHODS	The surgery was completed in a standard manner and the patients were randomized into three groups for the concentration of local anesthetic to continue the pain relief into the recovery phase .\
METHODS	On awakening , all patients were determined to have a functioning femoral nerve catheter .\
METHODS	Group 1 received 0.0625 % ( n = 8 ) bupivacaine , Group 2 0.125 % ( n = 9 ) bupivacaine , and Group 3 0.25 % ( n = 8 ) bupivacaine ; all doses were initiated in a blinded manner at 0.12 ml/kg/hr .\
METHODS	Patients also received intravenous patient-controlled analgesia with morphine via demand mode only , with a 1.0 mg dose and a 6 minute lock-out interval .\
RESULTS	Pain was determined at defined intervals by visual analog scale ( VAS ) .\
RESULTS	Data collected included demographics , VAS scores , and total morphine administered .\
RESULTS	All patients were pain-free on emergence from general anesthesia .\
RESULTS	No patient required parenteral opioid for pain control while in the postanesthesia care unit .\
RESULTS	There were no significant differences in pain scores among groups , and average pain scores ( 2.5 to 4.0 ) indicate good pain control throughout the entire hospitalization .\
RESULTS	There were no complications .\
CONCLUSIONS	Low concentrations of bupivacaine delivered via femoral nerve catheter after an established femoral nerve block can provide excellent postoperative pain control after ACL reconstruction .\
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###19673746\
BACKGROUND	Alcohol dependence is extremely common in patients with bipolar disorder and is associated with unfavorable outcomes including treatment nonadherence , violence , increased hospitalization , and decreased quality of life .\
BACKGROUND	While naltrexone is a standard treatment for alcohol dependence , no controlled trials have examined its use in patients with co-morbid bipolar disorder and alcohol dependence .\
BACKGROUND	In this pilot study , the efficacy of naltrexone in reducing alcohol use and on mood symptoms was assessed in bipolar disorder and alcohol dependence .\
METHODS	Fifty adult outpatients with bipolar I or II disorders and current alcohol dependence with active alcohol use were randomized to 12 weeks of naltrexone ( 50 mg/d ) add-on therapy or placebo .\
METHODS	Both groups received manual-driven cognitive behavioral therapy designed for patients with bipolar disorder and substance-use disorders .\
METHODS	Drinking days and heavy drinking days , alcohol craving , liver enzymes , and manic and depressed mood symptoms were assessed .\
RESULTS	The 2 groups were similar in baseline and demographic characteristics .\
RESULTS	Naltrexone showed trends ( p < 0.10 ) toward a greater decrease in drinking days ( binary outcome ) , alcohol craving , and some liver enzyme levels than placebo .\
RESULTS	Side effects were similar in the 2 groups .\
RESULTS	Response to naltrexone was significantly related to medication adherence .\
CONCLUSIONS	Results suggest the potential value and acceptable tolerability of naltrexone for alcohol dependence in bipolar disorder patients .\
CONCLUSIONS	A larger trial is needed to establish efficacy .\
\
###19131811\
BACKGROUND	We have previously demonstrated improved medical student performance using standardized live patient models in the Trauma Evaluation and Management ( TEAM ) program .\
BACKGROUND	The trauma manikin has also been offered as an option for teaching trauma skills in this program .\
BACKGROUND	In this study , we compare performance using both models .\
METHODS	Final year medical students were randomly assigned to three groups : group I ( n = 22 ) with neither model , group II ( n = 24 ) with patient model , and group III ( n = 24 ) with mechanical model using the same clinical scenario .\
METHODS	All students completed pre-TEAM and post-TEAM multiple choice question ( MCQ ) exams and an evaluation questionnaire scoring five items on a scale of 1 to 5 with 5 being the highest .\
METHODS	The items were objectives were met , knowledge improved , skills improved , overall satisfaction , and course should be mandatory .\
METHODS	Students ( groups II and III ) then switched models , rating preferences in six categories : more challenging , more interesting , more dynamic , more enjoyable learning , more realistic , and overall better model .\
METHODS	Scores were analyzed by ANOVA with p < 0.05 being considered statistically significant .\
RESULTS	All groups had similar scores ( means % + / - SD ) in the pretest ( group I - 50.8 + / - 7.4 , group II - 51.3 + / - 6.4 , group III - 51.1 + / - 6.6 ) .\
RESULTS	All groups improved their post-test scores but groups II and III scored higher than group I with no difference in scores between groups II and III ( group I - 77.5 + / - 3.8 , group II - 84.8 + / - 3.6 , group III - 86.3 + / - 3.2 ) .\
RESULTS	The percent of students scoring 5 in the questionnaire are as follows : objectives met - 100 % for all groups ; knowledge improved : group I - 91 % , group II - 96 % , group III - 92 % ; skills improved : group I - 9 % , group II - 83 % , group III - 96 % ; overall satisfaction : group I - 91 % , group II - 92 % , group III - 92 % ; should be mandatory : group I - 32 % , group II - 96 % , group III - 100 % .\
RESULTS	Student preferences ( 48 students ) are as follows : the mechanical model was more challenging ( 44 of 48 ) ; more interesting ( 40 of 48 ) ; more dynamic ( 46 of 48 ) ; more enjoyable ( 48 of 48 ) ; more realistic ( 32/48 ) , and better overall model ( 42 of 48 ) .\
CONCLUSIONS	Using the TEAM program , we have demonstrated that improvement in knowledge and skills are equally enhanced by using mechanical or patient models in trauma teaching .\
CONCLUSIONS	However , students overwhelmingly preferred the mechanical model .\
\
###21542026\
BACKGROUND	Acute alcohol intoxication selectively impairs executive functioning and prospective memory ( PM ) .\
BACKGROUND	Much previous researches in this area have used laboratorybased tasks that may not mimic functions that individuals with dysexecutive syndrome have problems with in their everyday life .\
BACKGROUND	The present study aimed to assess the effects of a modest dose of alcohol on executive functioning and PM using a virtual reality task and investigate the role of executive planning in PM performance .\
METHODS	Forty healthy participants were administered 0.4 g/kg alcohol or matched placebo in a doubleblind design .\
METHODS	Executive function and PM were assessed using the Jansari-Agnew-Akesson-Murphy ( JAAM ) task , requiring participants to play the role of an office worker .\
RESULTS	Alcohol intoxication selectively impaired executive function and PM .\
RESULTS	The participants in the alcohol condition performed worse on the planning , prioritisation , creativity and adaptability executive subscales and also on the timebased and eventbased PM tasks .\
RESULTS	However , alcohol did not impair the selection executive function task or the actionbased PM task .\
CONCLUSIONS	The results provide further support for the effects of alcohol on executive functioning and PM .\
CONCLUSIONS	In addition , the results suggest that such deficits may be present at relatively modest doses of alcohol and in the absence of a subjective feeling of intoxication .\
\
###18092565\
OBJECTIVE	To evaluate the relationship between the severity of cervical spinal cord injury ( SCI ) ( American Spinal Injury Association [ ASIA ] grade ) , presence of neurogenic shock , and timing of surgical intervention .\
OBJECTIVE	This is a post-hoc analysis from the Sygen multicenter randomized controlled trial .\
METHODS	Blood pressure ( BP ) and heart rate ( HR ) data were collected when patients were first assessed in the emergency room ( Time A ) and at the time of randomization ( Time B ) .\
METHODS	Individuals were subdivided by ASIA grade and by the level of the systolic BP ( SBP ) .\
RESULTS	Only individuals with cervical SCI from the Sygen trial ( n = 577 ) were evaluated .\
RESULTS	Severe complete SCI ( ASIA grade = A ) was established in 57 % of these patients .\
RESULTS	A total of 74 ( 13 % ) patients with neurogenic shock ( SBP < 90 mmHg ) at Time A were identified .\
RESULTS	The SBP increased significantly from Time A to Time B ( P < 0.0001 ) .\
RESULTS	The median time from SCI to surgical intervention , for ASIA A , was 80.9 hours for patients with initial SBP < 90 mmHg and 58 hours for patients with initial SBP > or = 90 mmHg ( P = 0.025 ) .\
RESULTS	Multivariable analysis after adjusting for confounders revealed a statistically significant difference in the time to surgical intervention based on SBP for ASIA A ( P = 0.026 ) , yet not for ASIA B or C/D .\
CONCLUSIONS	The presence of neurogenic shock was associated with a delay in the timing of surgical intervention in patients with cervical SCI .\
CONCLUSIONS	Detailed evaluation of autonomic dysfunctions following SCI including cardiovascular instability could improve our understanding of the complexities of clinical presentations and possible neurological outcomes .\
\
###18373854\
BACKGROUND	Referral of patients to smoking cessation telephone counseling ( i.e. , quitline ) is an underutilized resource by primary care physicians .\
BACKGROUND	Previously , we conducted a randomized trial to determine the effectiveness of benchmarked feedback on clinician referrals to a quitline .\
BACKGROUND	Subsequently , we sought to understand the successful practices used by the high-referring clinicians , and the perceptions of the barriers of referring patients to a quitline among both high and non-referring clinicians in the trial .\
METHODS	We conducted a qualitative sub-study with subjects from the randomized trial , comparing high - and non-referring clinicians .\
METHODS	Structured interviews were conducted and two investigators employed a thematic analysis of the transcribed data .\
METHODS	Themes and included categories were organized into a thematic framework to represent the main response sets .\
RESULTS	As compared to non-referring clinicians , high-referring clinicians more often reported use of the quitline as a primary source of referral , an appreciation of the quitline as an additional resource , reduced barriers to use of the quitline referral process , and a greater personal motivation related to tobacco cessation .\
RESULTS	Time and competing demands were critical barriers to initiating smoking cessation treatment with patients for all clinicians .\
RESULTS	Clinicians reported that having one referral source , a referral coordinator , and reimbursement for tobacco counseling ( as a billable code ) would aid referral .\
CONCLUSIONS	Further research is needed to test the effectiveness of new approaches in improving the connection of patients with smoking cessation resources .\
BACKGROUND	Clinicaltrials.gov NCT00529256 .\
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###18501565\
BACKGROUND	Loss aversion in decision-making refers to a higher sensitivity to losses than to gains .\
BACKGROUND	Loss aversion is conceived as an affective interference in cognitive processes such as judgment and decision-making .\
BACKGROUND	Loss aversion in non-risky choices has not been studied in schizophrenia .\
METHODS	Forty-two individuals with schizophrenia and 42 non-patient control subjects , matched by gender and age , were randomized to two different scenarios ( a buying scenario and a selling scenario ) .\
METHODS	Subjects were asked to evaluate the price of a decorated mug .\
METHODS	Schizophrenia subjects were re-tested four weeks later with the other scenario .\
RESULTS	Contrary to non-patient controls , schizophrenia subjects did not show loss aversion .\
RESULTS	In the schizophrenia group , absence of loss aversion was correlated with age , duration of illness , number of months in State hospitals , and poorer performance in the Wisconsin Card Sorting Test , but not with current psychopathology and two domains of emotional experience .\
CONCLUSIONS	Absence of loss aversion in schizophrenia represents a deficit in the processing of emotional information during decision-making .\
CONCLUSIONS	It can be interpreted as a lack of integration between the emotional and the cognitive systems , or to a more diffuse and de-differentiated impact of emotional information on decision-making .\
CONCLUSIONS	Future studies should bring more clarity to this question .\
\
###9561637\
OBJECTIVE	To investigate the effect of 3 months iron supplementation on physical growth among anemic school children given daily and weekly and to know the response based on hemoglobin level .\
METHODS	One hundred forty-four children were measured for height , weight and hemoglobin level .\
METHODS	Ninety seven children were anemic ( 67.36 % ) with Hb level < 12 g/dl and forty seven children were non anemic .\
METHODS	anemic children were divided into 2 subgroups and randomly assigned to either daily and weekly Fe treatment for 12 weeks .\
METHODS	The non anemic group were treated with weekly iron supplementation , which was accepted by the parents .\
METHODS	Children 's height , weight , and hemoglobin of T1 and T2 food recall method was used to know calorie , protein , vitamin C and iron intake in both daily and weekly subgroups .\
METHODS	Three days food recall was performed in the second and third months by a nutritionist .\
RESULTS	After iron supplementation , the hemoglobin level in both group increased significantly .\
RESULTS	The average change of hemoglobin between the 2 groups gave no significant difference .\
RESULTS	W/A and H/A after iron supplementation showed significantly increased in both groups .\
RESULTS	The average change of W/A and H/A between the 2 groups gave no significant difference .\
CONCLUSIONS	Daily and weekly iron supplementation showed no significant difference in increasing of hemoglobin level and physical growth .\
CONCLUSIONS	Further research must be done with appropriate sample size and well design .\
\
###18835885\
BACKGROUND	/ st > Airway Scope is a new videolaryngoscope which requires less cervical movement during intubation than direct laryngoscopy .\
BACKGROUND	Thus , in patients wearing a rigid cervical collar , we compared the efficacy of the Airway Scope and the gum elastic bougie with Macintosh laryngoscope during tracheal intubation .\
METHODS	/ st > Anaesthesia was induced with propofol , fentanyl , and rocuronium .\
METHODS	A rigid cervical collar was applied , and patients were randomly assigned to tracheal intubation with an Airway Scope ( n = 48 ) or multiple-use gum elastic bougie with Macintosh laryngoscope ( n = 48 ) .\
METHODS	Measurements included intubation time , gum elastic bougie insertion time , intubation success rate , and insertion and intubation attempts .\
METHODS	Airway complications were also recorded .\
RESULTS	/ st > The time required for successful intubation was significantly shorter with the Airway Scope compared with the gum elastic bougie with Macintosh laryngoscope [ mean ( sd ) 34 ( 13 ) vs 49 ( 27 ) s , P = 0.001 ] , although the overall success rate of the Airway Scope ( 100 % ) compared with the gum elastic bougie with Macintosh laryngoscope ( 90 % ) did not reach the statistical significance ( P = 0.056 ) .\
RESULTS	Oesophageal intubation ( n = 8 ) occurred only with the gum elastic bougie with Macintosh laryngoscope .\
RESULTS	Incidence of mucosal trauma and lip injury was similar with each device .\
RESULTS	No dental injury or hypoxia occurred with either device .\
CONCLUSIONS	/ st > The Airway Scope shortens intubation time , is less likely to result in oesophageal intubation , and may offer a marginally higher intubation success rate in patients with simulated restricted neck mobility .\
\
###17315796\
OBJECTIVE	Evaluate clinical and radiographic changes in primary teeth submitted to indirect pulp capping ( IPC ) over a 48-month-period .\
METHODS	Twenty seven primary molars with deep caries , but without preoperative signs of irreversible pulpits , were treated with IPC .\
METHODS	The teeth were randomly divided into two groups , according to the material used for protection of the dentin-pulp complex .\
METHODS	( 1 ) a calcium hydroxide liner ( Dycal ) and ( 2 ) glass ionomer cement ( Vitremer ) .\
RESULTS	After 48 months , Group-1 showed a success rate of 88.8 % and Group-2 of 93 % .\
RESULTS	No statistical significant difference between the groups was observed ( P = 0.62 ) .\
CONCLUSIONS	The results of this study suggested that indirect pulp capping in primary teeth arrests the progression of the underlying caries , regardless of the material used as a liner .\
\
###23047003\
OBJECTIVE	To describe the differences in treatment costs for infants randomized to contact lens correction versus primary intraocular lens ( IOL ) implantation after unilateral cataract surgery in the Infant Aphakia Treatment Study ( IATS ) .\
METHODS	Retrospective cost analysis of a prospective , randomized clinical trial based on Georgia Medicaid data and the actual costs of supplies used .\
METHODS	The IATS is a randomized , multicenter ( n = 12 ) clinical trial comparing treatment of aphakia with a primary IOL or contact lens in 114 infants with unilateral congenital cataract .\
METHODS	Infants underwent cataract surgery with or without placement of an IOL .\
METHODS	The mean cost of cataract surgery and all additional surgeries , examinations , and supplies used up to 12 months of age .\
RESULTS	The mean cost of treatment for a unilateral congenital cataract with primary IOL implantation was $ 14 752 versus $ 10 726 with contact lens correction .\
RESULTS	The initial cataract surgery accounted for approximately 50 % of the treatment costs for both groups .\
RESULTS	Contact lens costs accounted for 15 % ( $ 1600/patient ) in the aphakic group , whereas glasses costs represented only 4 % ( $ 535/patient ) in the IOL group .\
RESULTS	The increased costs in the IOL group were primarily due to the higher cost of cataract surgery in this group ( $ 7302 vs. $ 5357 ) and the cost of additional operations .\
CONCLUSIONS	For IATS patients up to 12 months of age , cataract surgery coupled with IOL implantation and spectacle correction was 37.5 % ( $ 4000 ) more expensive than cataract surgery coupled with contact lens correction .\
BACKGROUND	The author ( s ) have no proprietary or commercial interest in any materials discussed in this article .\
\
###16995860\
OBJECTIVE	Thiazolidinediones ( TZDs ) not only enhance cellular glucose transport but are reported to have potent anti-inflammatory effects .\
OBJECTIVE	These effects may play an important role in the insulin sensitizing mechanism , and possibly precede the effects on parameters of glucoregulation .\
OBJECTIVE	We sought to investigate whether these anti-inflammatory effects could yield early responding biomarkers for TZD action in Type 2 diabetes mellitus ( T2DM ) patients and healthy volunteers ( HV ) to expedite early clinical development of novel compounds .\
METHODS	We investigated the timing of treatment effects on several proinflammatory cytokines and markers of inflammation in comparison with effects on typical measures of glucoregulation in T2DM patients and HV receiving rosiglitazone 4 mg or placebo twice daily for 6 weeks .\
RESULTS	We found a significant reduction in interleukin ( IL ) -6 [ -39.4 % , confidence interval ( CI ) - 60.0 , - 8.2 ] and white blood cell count ( -18.4 % , CI - 30.2 , - 4.5 ) after 4 weeks of treatment in the T2DM group .\
RESULTS	These anti-inflammatory effects did not precede the effects on typical parameters of glucoregulation in the T2DM group and there was no significant anti-inflammatory response in the HV group .\
CONCLUSIONS	We could not identify biomarkers that precede the effects of rosiglitazone on parameters of glucoregulation in T2DM or that have a significant response in HV .\
CONCLUSIONS	However , the IL-6 response observed in this study indicates a potential role for this cytokine as complementary biomarker in clinical ` proof of concept ' studies with novel TZDs .\
\
###24352479\
BACKGROUND	Rheumatoid arthritis ( RA ) is one of the most prevalent autoimmune diseases worldwide .\
BACKGROUND	Some researchers have suggested that the serum vitamin D ( VitD ) level may relate to disease activity .\
BACKGROUND	The current study was designed to identify the correlation between vitaminD prescription and prevention of relapses in rheumatoid arthritis .\
METHODS	A double blinded , randomized controlled trial study was performed using 80RA patients .\
METHODS	RA was controlled and patients were in remission during the past 2months .\
METHODS	Serum level of VitD in the studied patients was below 30ng/dl .\
METHODS	Patients were randomly allocated to receive VitD or placebo .\
METHODS	In the 6-month follow-up period , the Disease Activity Score 28 ( DAS28 ) was used in case of relapses as an index of RA activity to compare the two groups .\
RESULTS	The flare rate was not different between two groups ( p > 0.05 ) .\
RESULTS	The odds ratio of the rate of decline in patients of the trial group compared with the control group was 1.17 ( not significant ; p > 0.05 ) .\
RESULTS	The mean DAS28 between the two patient groups was not significant ( p > 0.05 ) .\
CONCLUSIONS	A low VitD level was not identified to be a risk factor for RA severity or flare ups ; however , although not statistically significant , VitD treatment might be clinically effective .\
CONCLUSIONS	Further studies are needed with more emphasis on the issue of cost effectiveness and clinical importance to provide more information .\
\
###23602068\
BACKGROUND	Corticosteroids are widely used in pediatric open-heart surgery to reduce systemic inflammatory response and to mediate possible cardioprotective effects .\
BACKGROUND	However , the optimal dosing of corticosteroids is unknown and their administration varies considerably between different institutions .\
METHODS	Forty neonates undergoing open-heart surgery were randomized in a double-blind fashion equally into 2 groups .\
METHODS	After the induction of anesthesia , 1 group received 30 mg/kg intravenous methylprednisolone and the other a placebo .\
METHODS	Concentrations in plasma of interleukin 6 ( IL-6 ) , IL-8 , IL-10 , free methylprednisolone and total methylprednisolone were obtained for the following : ( 1 ) at anesthesia induction before the study drug was administered ; ( 2 ) 30 minutes on cardiopulmonary bypass ; ( 3 ) 5 minutes after protamine administration ; and ( 4 ) 6 hours after weaning from cardiopulmonary bypass .\
METHODS	Troponin T was measured at time points T1 , T3 , T4 , and also at 6:00 on the first postoperative morning .\
METHODS	Physiological and clinical outcome parameters were also recorded .\
RESULTS	Intravenous methylprednisolone resulted in high plasma drug concentrations that peaked at T2 .\
RESULTS	Methylprednisolone significantly lowered concentrations of proinflammatory cytokines IL-6 and IL-8 and raised levels of anti-inflammatory IL-10 .\
RESULTS	No significant differences in troponin T levels were detected .\
RESULTS	Blood glucose levels were significantly higher in the methylprednisolone group , and patients in this group received more often insulin therapy than controls .\
RESULTS	No significant differences were observed in other clinical or physiological outcome measurements .\
CONCLUSIONS	Intravenous 30 mg/kg methylprednisolone administered before cardiopulmonary bypass resulted in high effective plasma drug concentrations and a decreased inflammatory response .\
CONCLUSIONS	However , no cardioprotective effect or better clinical outcome was noticed .\
\
###15235901\
BACKGROUND	Febrile neutropenia ( FN ) remains a major dose-limiting complication among patients treated with chemotherapy .\
BACKGROUND	Haematopoietic colony stimulating factors ( G-CSF and GM-CSF ) made possible a significant improvement in the management of FN , both in the therapeutic and in the prophylactic approach .\
BACKGROUND	The use of antibiotic prophylaxis also permits a definite reduction of severe infections during neutropenia .\
BACKGROUND	Nevertheless , the possible role of these two interventions for secondary prevention of FN is still unclear .\
METHODS	We conducted a prospective randomised trial by comparing the efficacy of granulocyte-colony stimulating factor ( G-CSF ) and the association of G-CSF with oral antibiotics in the secondary prevention of FN .\
METHODS	We included in our study those patients who , after an episode of FN , continued to be treated with the same chemotherapy without reduction of dose intensity .\
METHODS	They were randomised into two groups : the first received G-CSF ( group G ; filgrastim , 5 microg/kg day ) , and the second was treated with an association of G-CSF and amoxicillin/clavulanate plus ciprofloxacin ( group G/ACC ) .\
RESULTS	Forty-eight patients were randomised ( group G : n = 23 and group G/ACC : n = 25 ) .\
RESULTS	There was no recurrence of FN among the patients receiving G-CSF and only one episode in the combined therapy group ( p = 1 ) .\
RESULTS	With regard to the side effects , there was no significant difference in the two groups .\
CONCLUSIONS	The use of G-CSF for the secondary prevention of FN is extremely effective and allows the maintenance of chemotherapy dose intensity .\
CONCLUSIONS	Our study showed that the addition of antibiotics does not seem to be required .\
\
###19717345\
BACKGROUND	Endovascular treatment ( angioplasty with or without stenting ) is an alternative to carotid endarterectomy for carotid artery stenosis but there are scarce long-term efficacy data showing that it prevents stroke .\
BACKGROUND	We therefore report the long-term results of the Carotid and Vertebral Artery Transluminal Angioplasty Study ( CAVATAS ) .\
METHODS	Between March , 1992 , and July , 1997 , patients who presented at a participating centre with a confirmed stenosis of the internal carotid artery that was deemed equally suitable for either carotid endarterectomy or endovascular treatment were randomly assigned to either treatment in equal proportions by telephone or fax from the randomisation service at the Oxford Clinical Trials Unit , UK .\
METHODS	Patients were seen by an independent neurologist at 1 and 6 months after treatment and then every year after randomisation for as long as possible , up to a maximum of 11 years .\
METHODS	Major outcome events were transient ischaemic attack , non-disabling , disabling , and fatal stroke , myocardial infarction , and death from any other cause .\
METHODS	Outcomes were adjudicated on by investigators who were masked to treatment .\
METHODS	Analysis was by intention to treat .\
METHODS	This study is registered , number ISRCTN 01425573 .\
RESULTS	504 patients with stenosis of the carotid artery ( 90 % symptomatic ) were randomly assigned to endovascular treatment ( n = 251 ) or surgery ( n = 253 ) .\
RESULTS	Within 30 days of treatment , there were more minor strokes that lasted less than 7 days in the endovascular group ( 8 vs 1 ) but the number of other strokes in any territory or death was the same ( 25 vs 25 ) .\
RESULTS	There were more cranial nerve palsies ( 22 vs 0 ) in the endarterectomy group than in the endovascular group .\
RESULTS	Median length of follow up in both groups was 5 years ( IQR 2-6 ) .\
RESULTS	By comparing endovascular treatment with endarterectomy after the 30-day post-treatment period , the 8-year incidence and hazard ratio ( HR ) at the end of follow-up for ipsilateral non-perioperative stroke was 11.3 % versus 8.6 % ( HR 1.22 , 95 % CI 0.59-2 .54 ) ; for ipsilateral non-perioperative stroke or TIA was 19.3 % versus 17.2 % ( 1.29 , 0.78-2 .14 ) ; and for any non-perioperative stroke was 21.1 % versus 15.4 % ( 1.66 , 0.99-2 .80 ) .\
CONCLUSIONS	More patients had stroke during follow-up in the endovascular group than in the surgical group , but the rate of ipsilateral non-perioperative stroke was low in both groups and none of the differences in the stroke outcome measures was significant .\
CONCLUSIONS	However , the study was underpowered and the confidence intervals were wide .\
CONCLUSIONS	More long-term data are needed from the on going stenting versus endarterectomy trials .\
BACKGROUND	British Heart Foundation ; UK National Health Service Management Executive ; UK Stroke Association .\
\
###12961817\
OBJECTIVE	To assess if eight counseling sessions conducted by women minimally trained as community counselors could reduce the mean level of anxiety and/or depression in women of their own community .\
METHODS	A randomized controlled trial .\
METHODS	A lower-middle-class , semi-urban community in Karachi , Pakistan .\
METHODS	366 anxious and/or depressed women providing informed consent .\
METHODS	Through systematic sampling , 1226 women were screened using an indigenous instrument .\
METHODS	Out of these , 366 women were found to have anxiety and/or depression and were randomized to intervention and control groups .\
METHODS	Women from the same community were trained in 11 sessions as counselors .\
METHODS	Subjects in the intervention group were counseled once weekly for eight weeks by the trained community counselors .\
METHODS	After the 8th session , the screening questionnaire was re-administered to both the groups .\
RESULTS	A significant reduction was found between the mean anxiety and depression scores of the two groups ( p value = 0.000 ) .\
CONCLUSIONS	Counseling by minimally trained community counselors reduced levels of anxiety and/or depression in women of their own community .\
\
###21969009\
BACKGROUND	In the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ( ALLHAT ) , a randomized , double-blind , practice-based , active-control , comparative effectiveness trial in high-risk hypertensive participants , risk of new-onset heart failure ( HF ) was higher in the amlodipine ( 2.5-10 mg/d ) and lisinopril ( 10-40 mg/d ) arms compared with the chlorthalidone ( 12.5-25 mg/d ) arm .\
BACKGROUND	Similar to other studies , mortality rates following new-onset HF were very high ( 50 % at 5 years ) , and were similar across randomized treatment arms .\
BACKGROUND	After the randomized phase of the trial ended in 2002 , outcomes were determined from administrative databases .\
RESULTS	With the use of national databases , posttrial follow-up mortality through 2006 was obtained on participants who developed new-onset HF during the randomized ( in-trial ) phase of ALLHAT .\
RESULTS	Mean follow-up for the entire period was 8.9 years .\
RESULTS	Of 1761 participants with incident HF in-trial , 1348 died .\
RESULTS	Post-HF all-cause mortality was similar across treatment groups , with adjusted hazard ratios ( 95 % confidence intervals ) of 0.95 ( 0.81-1 .12 ) and 1.05 ( 0.89-1 .25 ) , respectively , for amlodipine and lisinopril compared with chlorthalidone , and 10-year adjusted rates of 86 % , 87 % , and 83 % , respectively .\
RESULTS	All-cause mortality rates were also similar among those with reduced ejection fractions ( 84 % ) and preserved ejection fractions ( 81 % ) , with no significant differences by randomized treatment arm .\
CONCLUSIONS	Once HF develops , risk of death is high and consistent across randomized treatment groups .\
CONCLUSIONS	Measures to prevent the development of HF , especially blood pressure control , must be a priority if mortality associated with the development of HF is to be addressed .\
CONCLUSIONS	Clinical Trial Registration - http://www.clinicaltrials.gov .\
CONCLUSIONS	Unique identifier : NCT00000542 .\
\
###17341565\
BACKGROUND	Available data concerning effects of testosterone on endometrium of postmenopausal women are seriously limited .\
OBJECTIVE	Our aim was to compare the influence of treatment with testosterone and/or estrogen on endometrial proliferation in healthy postmenopausal women .\
METHODS	This was an open , randomized clinical study with parallel comparison of the groups .\
METHODS	The study was conducted at a women 's health clinical research unit and a research laboratory at a university hospital .\
METHODS	Sixty-three women who had experienced natural menopause participated in this study .\
METHODS	After random assignment , the participants were administered orally testosterone undecanoate ( 40 mg every second day ) , estradiol valerate ( 2 mg daily ) , or both for 3 months .\
METHODS	Endometrial thickness was measured , and endometrial proliferation evaluated on the basis of histopathology and expression of Ki-67 , a proliferation marker .\
RESULTS	Endometrial thickness was significantly increased by treatment with estrogen alone or in combination with testosterone but was unaltered by testosterone alone .\
RESULTS	Among the women receiving estrogen alone , the proportion exhibiting histopathology indicative of proliferation increased significantly to 50 % ( P < 0.05 ) , there was a nonsignificant increase to 28 % with the combined treatment , whereas testosterone alone had no effect at all .\
RESULTS	Expression of Ki-67 was up-regulated significantly in both glands and stroma ( P < 0.05 , respectively ) in both estrogen treatment groups .\
RESULTS	However , the expression was significantly higher in stroma by estrogen treatment alone than after combined treatment ( P < 0.05 ) .\
CONCLUSIONS	The short-term treatment with testosterone of postmenopausal women does not stimulate endometrial proliferation .\
CONCLUSIONS	In addition , testosterone appears to counteract endometrial proliferation induced by estrogen to a certain extent .\
\
###12883407\
BACKGROUND	Remifentanil is often combined with propofol for induction and maintenance of total intravenous anesthesia .\
BACKGROUND	The authors studied the effect of propofol on remifentanil requirements for suppression of responses to clinically relevant stimuli and evaluated this in relation to previously published data on propofol and alfentanil .\
METHODS	With ethics committee approval and informed consent , 30 unpremedicated female patients with American Society of Anesthesiologists physical status class I or II , aged 18-65 yr , scheduled to undergo lower abdominal surgery , were randomly assigned to receive a target-controlled infusion of propofol with constant target concentrations of 2 , 4 , or 6 microg/ml .\
METHODS	The target concentration of remifentanil was changed in response to signs of inadequate anesthesia .\
METHODS	Arterial blood samples for the determination of remifentanil and propofol concentrations were collected after blood-effect site equilibration .\
METHODS	The presence or absence of responses to various perioperative stimuli were related to the propofol and remifentanil concentrations by response surface modeling or logistic regression , followed by regression analysis .\
METHODS	Both additive and nonadditive interaction models were explored .\
RESULTS	With blood propofol concentrations increasing from 2 to 7.3 microg/ml , the C ( 50 ) of remifentanil decreased from 3.8 ng/ml to 0 ng/ml for laryngoscopy , from 4.4 ng/ml to 1.2 ng/ml for intubation , and from 6.3 ng/ml to 0.4 ng/ml for intraabdominal surgery .\
RESULTS	With blood remifentanil concentrations increasing from 0 to 7 ng/ml , the C ( 50 ) of propofol for the return to consciousness decreased from 3.5 microg/ml to 0.6 microg/ml .\
CONCLUSIONS	Propofol reduces remifentanil requirements for suppression of responses to laryngoscopy , intubation , and intraabdominal surgical stimulation in a synergistic manner .\
CONCLUSIONS	In addition , remifentanil decreases propofol concentrations associated with the return of consciousness in a synergistic manner .\
\
###15672272\
BACKGROUND	The potential to improve cognition in older women with estrogen or estrogen/progesterone therapy is currently a matter of intense debate .\
BACKGROUND	Only a few studies conducted so far have used electrophysiological indicators of cognitive information processing as outcome measures in randomised placebo controlled studies .\
OBJECTIVE	This study was undertaken to measure changes in event-related potentials ( ERPs ) after short ( 4 weeks ) or prolonged ( 24 weeks ) hormone treatment in older women .\
METHODS	A randomised , double-blind , placebo-controlled study in hysterectomized older women ( aged 58-75 years ) was performed ( n = 51 ) .\
METHODS	The participants received orally estradiol ( 2 mg estradiol valerate ) , estradiol plus progesterone ( 100 mg micronized progesterone ) or placebo for 24 weeks .\
METHODS	Using four different paradigms , early and late ERPs were assessed at baseline and after 4 and 24 weeks of treatment .\
RESULTS	Strong hormone increases were observed in the two active treatment groups .\
RESULTS	However , no significant effects on any of the assessed ERPs were observed in either of the two treatment groups .\
RESULTS	Similar non-significant findings were obtained for reaction time and error rate .\
CONCLUSIONS	Estradiol or estradiol/progesterone treatment appears to have no strong effects on several ERP markers of information processing in older hysterectomized women .\
CONCLUSIONS	The current negative findings might suggest a reduced sensitivity of the aged brain to gonadal steroids .\
\
###17291166\
BACKGROUND	Although mindfulness meditation interventions have recently shown benefits for reducing stress in various populations , little is known about their relative efficacy compared with relaxation interventions .\
OBJECTIVE	This randomized controlled trial examines the effects of a 1-month mindfulness meditation versus somatic relaxation training as compared to a control group in 83 students ( M age = 25 ; 16 men and 67 women ) reporting distress .\
METHODS	Psychological distress , positive states of mind , distractive and ruminative thoughts and behaviors , and spiritual experience were measured , while controlling for social desirability .\
RESULTS	Hierarchical linear modeling reveals that both meditation and relaxation groups experienced significant decreases in distress as well as increases in positive mood states over time , compared with the control group ( p < .05 in all cases ) .\
RESULTS	There were no significant differences between meditation and relaxation on distress and positive mood states over time .\
RESULTS	Effect sizes for distress were large for both meditation and relaxation ( Cohen 's d = 1.36 and .91 , respectively ) , whereas the meditation group showed a larger effect size for positive states of mind than relaxation ( Cohen 's d = .71 and .25 , respectively ) .\
RESULTS	The meditation group also demonstrated significant pre-post decreases in both distractive and ruminative thoughts/behaviors compared with the control group ( p < .04 in all cases ; Cohen 's d = .57 for rumination and .25 for distraction for the meditation group ) , with mediation models suggesting that mindfulness meditation 's effects on reducing distress were partially mediated by reducing rumination .\
RESULTS	No significant effects were found for spiritual experience .\
CONCLUSIONS	The data suggest that compared with a no-treatment control , brief training in mindfulness meditation or somatic relaxation reduces distress and improves positive mood states .\
CONCLUSIONS	However , mindfulness meditation may be specific in its ability to reduce distractive and ruminative thoughts and behaviors , and this ability may provide a unique mechanism by which mindfulness meditation reduces distress .\
\
###19785256\
OBJECTIVE	We investigated the application of dynamic assessment in examining learning potential for adults with right hemisphere stroke and unilateral neglect .\
METHODS	Forty adults with right cerebrovascular accident were randomly assigned to a control or dynamic group .\
METHODS	Both groups were administered standard pretests and posttests of unilateral neglect .\
METHODS	The dynamic group received cues , strategy training , and feedback during an object search task .\
RESULTS	Multivariate analysis of covariance indicated significant differences between groups on the object search task , with reduced unilateral neglect in the dynamic group .\
RESULTS	Greater initiation of left-sided search , strategy use , and near and intermediate transfer of learning were observed in the dynamic group .\
CONCLUSIONS	The brief dynamic assessment , developed for this study , provided an opportunity to observe the client 's ability to incorporate strategy training and feedback across visual search tasks .\
CONCLUSIONS	This assessment approach has the potential to characterize learning profiles and to guide intervention decisions .\
\
###24783926\
OBJECTIVE	To explore the effects of five-element music therapy on elderly patients with seasonal affective disorder in a Chinese nursing home .\
METHODS	The patients ( n = 50 ) were recruited from a Shijingshan district nursing home in Beijing , China .\
METHODS	They were randomly assigned to two groups , a treatment group and a control group , with 25 participants in each group .\
METHODS	The patients received music therapy for 1-2 h each week over an 8-week period .\
METHODS	The music therapy involved four phases : introduction , activities , listening to the Chinese five-element music , and a concluding phase .\
METHODS	The participants in the control group did not listen to the five-element music .\
METHODS	This study consisted of two parts : ( a ) a qualitative study that used focus groups to understand the feelings of the patients with seasonal affective disorder ; ( b ) a quantitative study that involved administration of the self-rating depression scale ( SDS ) and Hamilton depression scale ( HAMD ) before and after treatment .\
RESULTS	( a ) Qualitative analysis results : strength derived from the five-element group music therapy and emotional adjustment .\
RESULTS	The five-element group music therapy can reduce patients ' psychological distress and let them feel inner peace and enhance their life satisfaction .\
RESULTS	( b ) No significant difference in SDS and HAMD scores was found between the two groups ( P > 0.05 ) prior to treatment .\
RESULTS	After treatment , the mean SDS score of the control group was 49.9 + / - 18.8 , while the treatment group 's score was 40.2 + / - 18.1 .\
RESULTS	The HAMD score of the control group was 11.2 + / -3.1 , and the treatment group 's score was 8.8 + / - 4.9 .\
RESULTS	Following 8 weeks of music therapy , the SDS and HAMD scores of the treatment group were significantly lower than those for the control group ( P < 0.05 ) .\
CONCLUSIONS	Five-element music therapy alleviated the symptoms of seasonal affective disorder in the elderly patients .\
\
###15370078\
OBJECTIVE	The present report evaluates the effect of acute L-arginine administration on fetal heart variables by a computerized non-stress test ( NST ) analysis .\
METHODS	Fifteen pregnant women at 30-34 weeks of gestational age affected by mild to moderate gestational hypertension were enrolled in the study .\
METHODS	The study was performed in the second and third days of hospitalization .\
METHODS	Each woman received both active ( Arg ) or placebo treatment ( Placebo ) , in a double-blind , randomized , cross-over design .\
METHODS	Women received saline infusion for 40 min , then they were infused with either placebo ( saline infusion prepared by Damor Pharmaceutics and labeled as Arg-B ) or Arg ( L-Arg 20 g/500 ml labeled as Arg-A ) .\
RESULTS	Multiple analysis of variance ( MANOVA ) indicated that both placebo and Arg infusion were unable to affect cardiac variables and fetal movements .\
RESULTS	As far as maternal blood pressure changes were concerned , MANOVA indicated that active treatment showed an acute hypotensive effect on both systolic ( F = 8.98 , p < 0.001 ) and diastolic values ( F = 15.78 , p > 0.001 ) .\
RESULTS	Conversely , placebo infusion does not seems to have induced any change .\
RESULTS	Considering each time of infusion we observed that Arg treatment was able to lower systolic and diastolic blood pressure after the 40 min of infusion , with this effect persisting for 20 min .\
CONCLUSIONS	These data indicate that the acute , intravenous administration of high-dose L-arginine does not induce significant changes in fetal heart rate ( FHR ) , whereas it lowers maternal blood pressure .\
CONCLUSIONS	Such conclusions are reinforced by the observation that saline administration in the same pregnant women was neutral for both FHR and maternal blood pressure values .\
CONCLUSIONS	According to previous studies , it seems conceivable that maternal L-arginine treatment enters the fetal circulation by crossing the placenta .\
CONCLUSIONS	The lack of changes in FHR , however , suggests that no significant hemodynamic changes were induced by the treatment .\
CONCLUSIONS	Contrary to what happens in the mother , this may possibly be due to a low , if any , conversion of L-arginine to nitric oxide in the fetus .\
\
###9491878\
OBJECTIVE	To evaluate the effect of estrogen replacement therapy on cognitive functioning .\
METHODS	The study consisted of two 3-month treatment periods , one with estrogen and one with the placebo , in random order , separated by a 1-month wash-out period .\
METHODS	The study group comprised 70 healthy postmenopausal women , aged 47-65 years , with previous hysterectomy .\
METHODS	Sixty-two women completed the study .\
METHODS	Cognitive speed and accuracy , attention , and memory were evaluated .\
METHODS	Serum estradiol ( E2 ) and FSH levels were controlled at the end of the estrogen , placebo , and wash-out periods .\
RESULTS	Most of the cognitive tests correlated with age : older women were slower and made more errors than younger women .\
RESULTS	Estrogen replacement therapy was not superior to the placebo in any test of cognitive performance .\
RESULTS	In two out of ten visual detection tasks , recognition thresholds were longer with estrogen than with the placebo ( P < .001 and P = .004 ) .\
RESULTS	On the most demanding test of working memory , the reaction times ( P = .045 ) and error rates ( P = .043 ) differed between treatments , yet this finding proved to be an effect of learning rather than treatment .\
RESULTS	There was no correlation between cognitive performance and serum E2 levels .\
CONCLUSIONS	Cognitive performance decreased with age .\
CONCLUSIONS	Short-term estrogen replacement therapy did not provide any advantage over the placebo in terms of improving the performance .\
\
###18360262\
BACKGROUND	Clinical data are lacking concerning concomitant administration of everolimus and tacrolimus in renal transplant recipients .\
METHODS	In a prospective , multicenter , open-label , exploratory , randomized , 6-month study , 92 de novo renal transplant patients received everolimus , steroids , and basiliximab with low or standard tacrolimus exposure .\
METHODS	The primary objective was to compare renal function at 6 months after transplant .\
RESULTS	Mean 6-month serum creatinine ( primary safety variable ) was 112 + / -31 micromol/L ( 1.26 + / -0.35 mg/dL ) and 127 + / -50 micromol/L ( 1.44 + / -0.57 mg/dL ) in the low and standard tacrolimus groups , respectively , ( n.s. ) ; mean estimated GFR ( Nankivell ) was 75.3 + / -16.6 mL/min and 72.5 + / -15.2 mL/min ( n.s. ) .\
RESULTS	Biopsy-proven acute rejection occurred in 13 patients : seven ( 14 % ) in the low tacrolimus group and six ( 14 % ) in the standard tacrolimus group , n.s.\
RESULTS	One graft was lost in the standard tacrolimus group .\
RESULTS	No patients died .\
CONCLUSIONS	Tacrolimus exposure reduction in the presence of everolimus , steroids and basiliximab induction results in good efficacy in de novo renal transplant recipients with very well-preserved renal function .\
CONCLUSIONS	Additional studies are warranted because between-group comparisons were limited by the relatively small differences in tacrolimus exposure in the 2 arms ; trough levels were toward the upper end of the low-exposure ranges and toward the bottom of the standard-exposure ranges .\
\
###22749632\
OBJECTIVE	Previous analysis of this Intergroup trial demonstrated that with a median follow-up among surviving patients of 45.9 months , the concurrent postoperative administration of cisplatin and radiation therapy improved local-regional control and disease-free survival of patients who had high-risk resectable head-and-neck carcinomas .\
OBJECTIVE	With a minimum of 10 years of follow-up potentially now available for all patients , these results are updated here to examine long-term outcomes .\
METHODS	A total of 410 analyzable patients who had high-risk resected head-and-neck cancers were prospectively randomized to receive either radiation therapy ( RT : 60 Gy in 6 weeks ) or identical RT plus cisplatin , 100 mg/m ( 2 ) i.v. on days 1 , 22 , and 43 ( RT + CT ) .\
RESULTS	At 10 years , the local-regional failure rates were 28.8 % vs 22.3 % ( P = .10 ) , disease-free survival was 19.1 % vs 20.1 % ( P = .25 ) , and overall survival was 27.0 % vs 29.1 % ( P = .31 ) for patients treated by RT vs RT + CT , respectively .\
RESULTS	In the unplanned subset analysis limited to patients who had microscopically involved resection margins and/or extracapsular spread of disease , local-regional failure occurred in 33.1 % vs 21.0 % ( P = .02 ) , disease-free survival was 12.3 % vs 18.4 % ( P = .05 ) , and overall survival was 19.6 % vs 27.1 % ( P = .07 ) , respectively .\
CONCLUSIONS	At a median follow-up of 9.4 years for surviving patients , no significant differences in outcome were observed in the analysis of all randomized eligible patients .\
CONCLUSIONS	However , analysis of the subgroup of patients who had either microscopically involved resection margins and/or extracapsular spread of disease showed improved local-regional control and disease-free survival with concurrent administration of chemotherapy .\
CONCLUSIONS	The remaining subgroup of patients who were enrolled only because they had tumor in 2 or more lymph nodes did not benefit from the addition of CT to RT. .\
\
###17975496\
OBJECTIVE	To study the progression-free survival ( PFS ) and toxicity with 25 - or 250-mg doses of temsirolimus ( CCI-779 ) after induction chemotherapy in patients with extensive small-cell lung cancer .\
METHODS	Patients with either stable or responding disease to four to six cycles of cisplatin or carboplatin plus etoposide or irinotecan were randomized between 4 and 8 weeks after completion of induction therapy to receive either 25 or 250 mg of temsirolimus intravenously every week until disease progression .\
RESULTS	Eighty-seven patients entered between January 2002 and December 2003 , of whom 85 were eligible : 44 received 25 mg ( arm A ) , and 41 received 250 mg ( arm B ) .\
RESULTS	The overall median follow-up time for all eligible patients was 34.6 months .\
RESULTS	Median age was 59 years ( range , 39-80 ) ; 42 ( 49.4 % ) were male and 43 ( 50.6 % ) female ; 12.9 % had brain metastases .\
RESULTS	The overall median and 1-year PFS were 2.2 months ( 95 % confidence interval [ CI ] : 1.8 , 2.9 ) and 4.7 % ( 95 % CI : 0.2 % , 9.2 % ) , respectively .\
RESULTS	The median PFS ( 95 % CI ) for arm A was 1.9 months ( 1.6 , 2.3 ) ; for arm B , it was 2.5 months ( 1.9 , 3.4 ; p = 0.24 ) .\
RESULTS	The median overall survival from randomization was 8 months ( 95 % CI : 6.5 , 9.5 ) .\
RESULTS	Among the 86 patients with reported toxicities , 36 ( 42 % ) had grade 3 toxicities , the most common of which were thrombocytopenia , hypophosphatemia , and fatigue , and an additional 12 ( 14 % ) had grade 4 toxicities , the most common of which was neutropenia .\
RESULTS	No patients experienced lethal toxicities .\
CONCLUSIONS	Temsirolimus ( CCI 779 ) , given at 25 or 250 mg weekly , seemed not to increase the PFS in this patient population .\
\
###19187327\
BACKGROUND	End-organ hyperreactivity is an important feature of the allergic airway .\
BACKGROUND	There are no data directly comparing the responsiveness to treatment of different nasal provocation tests ( NPT ) .\
OBJECTIVE	We compared the effect of levocetirizine on nasal adenosine 5 ' - monophosphate ( AMP ) with specific allergen challenge in patients with intermittent and persistent allergic rhinitis ( AR ) .\
METHODS	Patients with AR were randomized in double-blind cross-over fashion to receive single doses of levocetirizine 5 mg or identical placebo , with nasal challenge performed 12 h after dosing .\
METHODS	Sixteen participants completed per protocol .\
METHODS	Nasal AMP or allergen challenge was conducted on separate days with 1 - and 2-week washout periods in between , respectively .\
METHODS	Measurements of peak nasal inspiratory flow ( PNIF ) were made over 60 min after each challenge .\
METHODS	The primary end-point was the provocative concentration of AMP or allergen causing a 20 % drop in the PNIF ( PC ( 20 ) ) .\
RESULTS	The time-profile for PNIF recovery [ area under the 60 min time-response curve as % PNIF change ( min ) ] were significantly attenuated for AMP challenge , as mean difference [ 95 % confidence interval ( CI ) ] : 11.57 ( 3.87 , 19.25 ) , P = 0.005 and for allergen challenge : 17.82 ( 0.11 , 35.53 ) , P = 0.04 .\
RESULTS	A highly significant correlation was shown between methods for the area under the curve : ( R = 0.86 , P < 0.001 ) .\
RESULTS	A statistically significant correlation was also seen for the PC ( 20 ) : ( R = 0.94 , P < 0.001 ) .\
RESULTS	PC ( 20 ) improvement amounted to a 1.26 ( 95 % CI 0.16 , 2.35 ) and 0.16 ( 95 % CI -0.41 , 0.73 ) doubling-dilution shifts for allergen and AMP challenges , respectively .\
RESULTS	Bland-Altman plots confirmed good agreement between methods .\
CONCLUSIONS	A high correlation and statistical agreement has been demonstrated between AMP and allergen challenge for all outcome measures .\
CONCLUSIONS	In particular , the recovery profile after NPT is a sensitive and discriminatory measure of anti-allergic treatment .\
\
###16966534\
OBJECTIVE	To compare the efficacy and safety of rivastigmine ( 3 to 6 mg/day ) vs placebo over 12 weeks in patients with traumatic brain injury and persistent cognitive impairment .\
METHODS	This prospective , randomized , double-blind , placebo-controlled study was conducted in 157 patients at least 12 months after injury .\
METHODS	The primary efficacy measures were the Cambridge Neuropsychological Test Automated Battery ( CANTAB ) Rapid Visual Information Processing ( RVIP ) A ' subtest and the Hopkins Verbal Learning Test ( HVLT ) .\
METHODS	The primary efficacy outcome was the proportion of patients who demonstrated 1.0 SD or greater improvement from baseline at week 12 on CANTAB RVIP A ' or HVLT .\
RESULTS	The percentage of responders at week 12 on either the CANTAB RVIP A ' or HVLT was 48.7 % for rivastigmine and 49.3 % for placebo ( p = 0.940 ) .\
RESULTS	Furthermore , for the overall study population , there were no significant differences for any of the secondary efficacy variables .\
RESULTS	In a subgroup of patients with moderate to severe memory impairment ( n = 81 ) , defined as 25 % impairment or greater on HVLT at baseline , rivastigmine was significantly better than placebo for a number of measures , including the proportion of HVLT responders and CANTAB RVIP mean latency .\
CONCLUSIONS	Rivastigmine was safe and well tolerated in patients with traumatic brain injury with cognitive deficits .\
CONCLUSIONS	Rivastigmine shows promising results in the subgroup of patients with traumatic brain injury with moderate to severe memory deficits .\
\
###20529368\
BACKGROUND	With the rapid worldwide increase in the oldest old population , considerable concern has arisen about the social and economic burden of diseases and disability in this age group .\
BACKGROUND	Understanding of multidimensional structure of health and its life-course trajectory is an essential prerequisite for effective health care delivery .\
BACKGROUND	Therefore , we organized an interdisciplinary research team consisting of geriatricians , dentists , psychologists , sociologists , and epidemiologists to conduct a longitudinal observational study .\
METHODS	For the Tokyo Oldest Old Survey on Total Health ( TOOTH ) study , a random sample of inhabitants of the city of Tokyo , aged 85 years or older , was drawn from the basic city registry .\
METHODS	The baseline comprehensive assessment consists of an in-home interview , a self-administered questionnaire , and a medical/dental examination .\
METHODS	To perform a wide variety of biomedical measurements , including carotid ultrasonography and a detailed dental examination , participants were invited to our study center at Keio University Hospital .\
METHODS	For those who were not able to visit the study center , we provided the option of a home-based examination , in which participants were simultaneously visited by a geriatrician and a dentist .\
METHODS	Of 2875 eligible individuals , a total of 1152 people were recruited , of which 542 completed both the in-home interview and the medical/dental examination , with 442 completed the in-home interview only , and another 168 completed self or proxy-administered data collection only .\
METHODS	Carotid ultrasonography was completed in 458 subjects , which was 99.6 % of the clinic visitors ( n = 460 ) .\
METHODS	Masticatory assessment using a colour-changeable chewing gum was completed in 421 subjects , a 91.5 % of the clinic visitors .\
CONCLUSIONS	Our results demonstrated the feasibility of a new comprehensive study that incorporated non-invasive measurements of subclinical diseases and a detailed dental examination aiming at community-dwelling individuals aged 85 years or older .\
CONCLUSIONS	The bimodal recruitment strategy is critically important to capture a broad range of health profiles among the oldest old .\
CONCLUSIONS	Results form the TOOTH study will help develop new models of health promotion , which are expected to contribute to an improvement in lifelong health and well-being .\
\
###16469681\
OBJECTIVE	The safety of selective cyclooxygenase-2 inhibitors in patients with ulcerative colitis in remission is unknown .\
METHODS	We performed a placebo-controlled pilot trial to evaluate the safety of celecoxib in patients with ulcerative colitis in remission who had a present or past history of nonspecific arthritis , arthralgia , or other condition amenable to nonsteroidal anti-inflammatory drug therapy .\
METHODS	A total of 222 patients with ulcerative colitis in remission were randomized to receive oral celecoxib 200 mg or placebo twice daily for 14 days .\
METHODS	Remission was defined as a total Mayo Clinic score of 2 points or less and an endoscopic score of 1 point or less .\
METHODS	Disease exacerbation was defined as a total Mayo Clinic score of 5 points or more and an increase in the endoscopic score of 1 point or more .\
METHODS	The primary analysis was disease exacerbation through day 14 among patients who underwent randomization , had at least 1 dose of study drug , and had both endoscopy and Mayo Clinic disease activity index scores at the baseline and final assessments .\
RESULTS	Three percent of patients in the celecoxib group experienced disease exacerbation through day 14 , as compared with 4 % in the placebo group ( P = .719 ) .\
RESULTS	Eleven percent of patients in each group experienced a bowel-related adverse event ( P > .20 ) .\
CONCLUSIONS	Therapy with celecoxib for up to 14 days did not have a greater relapse rate than placebo in patients with ulcerative colitis in remission who had a present or past history of nonspecific arthritis , arthralgia , or other condition amenable to nonsteroidal anti-inflammatory drug therapy .\
\
###7953039\
BACKGROUND	We developed and evaluated a comprehensive , ongoing intervention for families of schizophrenic patients appropriate for China 's complex family relationships and unique social environment .\
METHODS	Sixty-three DSM-III-R schizophrenic patients living with family members were enrolled when admitted to hospital and randomly assigned to receive standard care or a family-based intervention that included monthly 45-minute counselling sessions focused on the management of social and occupational problems , medication management , family education , family group meetings , and crisis intervention .\
RESULTS	At 6 , 12 , and 18-month follow-ups by blind evaluators , the proportion of subjects rehospitalised was lower , the duration of rehospitalisation was shorter , and the duration of employment was longer in the experimental group than in the control group ; these differences were statistically significant at the 12 and 18-month follow-ups and were not explained by differences in drug compliance .\
RESULTS	Family intervention was associated with significantly lower levels of family burden .\
CONCLUSIONS	This intervention is less costly than standard treatment , is suitable for urban families of schizophrenic patients in China and feasible given the constraints of the Chinese mental health system .\
\
###11709448\
OBJECTIVE	To determine whether long term doxycycline improves symptoms in patients with chronic seronegative or reactive arthritis .\
METHODS	A randomised , triple blind , controlled clinical trial of three months ' treatment with doxycycline or placebo of patients with chronic reactive or seronegative arthritis was conducted .\
METHODS	The primary study end points were three month pain and functional status measured by a self administered Arthritis Impact Measurement Scales version 2 ( AIMS2 ) quality of life questionnaire .\
METHODS	Secondary end points were pain and functional status at 6-12 months , three month rheumatologist assessed joint count , pain , and arthritis activity , and treatment efficacy in those with previous exposure to chlamydia .\
RESULTS	Of 60 patients randomly allocated to receive doxycycline or placebo , results from 37 were evaluable at three months .\
RESULTS	Groups were well balanced for major prognostic variables .\
RESULTS	Doxycycline had no detectable effect at three months on pain change scores ( mean difference 1.5 , 95 % CI -1.2 to 4.2 , p = 0.25 ) or composite functional change scores ( mean difference 0.8 , 95 % CI -5.6 to 7.1 , p = 0.81 ) .\
RESULTS	Furthermore , there were no differences in secondary study end points , and no apparent treatment effect in patients with previous chlamydia infection .\
CONCLUSIONS	Three months ' treatment with doxycycline did not improve pain or functional status in patients with chronic reactive or seronegative arthritis .\
\
###22916513\
OBJECTIVE	The aim of this study is to find out if an ultrasound technique has advantages over the conventional landmark technique .\
METHODS	This is a prospective randomized comparative study on 120 patients requiring central venous cannulation of the right internal jugular vein .\
METHODS	The study comprised of two groups : ultrasound and landmark groups , each consisting of 60 patients .\
METHODS	The outcome measures were compared between the groups .\
RESULTS	Cannulation of the internal jugular vein was successful in 58 patients in the ultrasound group and in 53 in the landmark group .\
RESULTS	The number of attempts was 1.5 ( 1 - 3 ) and 2 ( 1 - 3 ) in the ultrasound and landmark group respectively ( p = 0.001 ) .\
RESULTS	The time taken for the successful cannulation was 4.9 + / - 1.7 minutes in the ultrasound approach and 8.0 + / - 2.8 minutes in the landmark approach ( p = 0.00 ) .\
RESULTS	The internal jugular vein diameter in the supine position was 11.2 + / - 1.5 mm which increased to 15.04 + / - 1.5 mm with a 15 degrees head-down position in the USG group ( p = 0.001 ) .\
RESULTS	The first attempt success rate was 39/60 ( 63 % ) in the ultrasound group and 19/60 ( 32 % ) with the landmark technique .\
RESULTS	The seven ( 12 % ) failure cases in the landmark group were rescued by the ultrasound technique .\
RESULTS	Inadvertent carotid artery puncture occurred in 2/60 ( 3 % ) and 6/60 ( 10 % ) of patients in the ultrasound and land mark group respectively .\
CONCLUSIONS	Ultrasound improves success rate , minimizes cannulation time and complications during internal jugular vein cannulation .\
CONCLUSIONS	It can be employed as a rescue technique in cases of a failed landmark technique .\
\
###14597939\
BACKGROUND	A number of stent-versus-stent trials have not been able to disclose differences in stent performance .\
BACKGROUND	It has been hypothesized that the selection of patient subsets with simple lesion morphologies may have masked differences among the stent designs under testing .\
BACKGROUND	The randomized Intracoronary Stenting and Angiographic Results Strut Thickness Effect on Restenosis Outcome ( ISAR-STEREO ) trial has shown that a reduced stent strut thickness is associated with a reduced risk for restenosis .\
BACKGROUND	The rationale of this study was to investigate the role of lesion complexity on the capacity of a stent-versus-stent trial to distinguish between superior and inferior stents .\
METHODS	In the ISAR-STEREO trial , 651 patients were randomly assigned to receive either a thin-strut ( n = 326 ) or a thick-strut stent ( n = 325 ) with a comparable stent design .\
METHODS	Restenosis , defined as a > or = 50 % diameter stenosis at follow-up angiography , was analyzed according to the lesion complexity , which was assessed with the use of the American College of Cardiology/American Heart Association classification system .\
RESULTS	The restenosis rate did not differ between stent designs in patients with noncomplex lesions ( type A or B ( 1 ) ; restenosis rate : 16.7 % vs 16.7 % , P = 1.0 for thin-strut vs thick-strut stents ) .\
RESULTS	In patients with complex lesions ( type B2 or C ) , there was a significant reduction in restenosis in the thin-strut stent group ( restenosis rate : 14.5 % vs 29.0 % ; P < .01 for thin-strut vs thick-strut stents ) .\
CONCLUSIONS	The results of this study suggest that the potential to detect differences in the risk for restenosis in stent-versus-stent trials is strongly dependent on the inclusion of patients with complex lesions .\
CONCLUSIONS	These findings may be relevant when planning new stent-versus-stent trials .\
\
###10765864\
OBJECTIVE	The purpose of this project was to evaluate the performance of a dentin adhesive system on carious and noncarious primary dentin in vivo .\
METHODS	Forty-eight primary molars with carious lesions were randomly assigned to 2 different treatments : group 1 ( control , n = 24 ) -- All identifiable , irreversibly infected dentin was removed prior to the application of the bonding agent and restorative material ; group 2 ( experimental , n = 24 ) -- Irreversibly infected dentin was partially removed prior to the application of the bonding agent and restorative material .\
METHODS	The control and experimental teeth were clinically monitored every 3 months and evaluated 12 months after restoration .\
METHODS	The teeth were extracted around the time of exfoliation and processed for scanning electron microscopy .\
RESULTS	Retention rate , marginal integrity , and pulpal symptoms were identical in both groups .\
RESULTS	Radiographically , the radiolucent area associated with the experimental restorations did not increase with time in 75 % of the cases .\
RESULTS	For the control group , the adhesive system formed a hybrid layer .\
RESULTS	In the experimental group , there was morphologic evidence of the formation of an acid-resistant `` altered hybrid layer . ''\
RESULTS	An acid-resistant tissue , resulting from the interdiffusion of adhesive resin within the area of carious dentin , was observed adjacent to and under the altered hybrid layer .\
CONCLUSIONS	Application of an adhesive restorative system to irreversibly infected dentin did not affect the clinical performance of the restoration .\
\
###16773290\
BACKGROUND	Fibre is often recommended as the first-choice treatment but its effects can be uneven .\
BACKGROUND	The aim of the study was to compare the clinical efficacy and tolerability of fibre versus lactulose in outpatients with chronic constipation .\
METHODS	In a prospective randomized crossover trial , patients were randomized to receive fibre or lactulose for four weeks .\
METHODS	Between treatments , patients had at least one week free of laxatives .\
RESULTS	50 patients , of median age 50 years ( range , 18-85 ) were recruited and 39 patients completed the trial .\
RESULTS	Compared to fibre , lactulose resulted in significantly higher mean bowel frequency ( 7.3 , 95 % CI 5.7 to 8.9 vs. 5.5 , 95 % CI 4.4 to 6.5 ; p = 0.001 ) and stool consistency score ( 3.4 , 95 % CI 3.1 to 3.7 vs. 2.9 , 95 % CI 2.5 to 3.3 ; p = 0.018 ) .\
RESULTS	Scores for ease of evacuation were similar .\
RESULTS	The frequencies of adverse effects were not significantly different , but greater in the lactulose group .\
RESULTS	Mean patients ' recorded improvement score was significantly higher after taking lactulose than fibre ( 6.2 , 95 % CI 5.5 to 7.0 vs. 4.8 , 95 % CI 4.0 to 5.9 ; p = 0.017 ) .\
RESULTS	Of the 39 patients who completed the trial , 24 ( 61.5 % ) preferred lactulose and 14 ( 35.9 % ) preferred fibre .\
CONCLUSIONS	Lactulose had better efficacy than fibre for chronic constipation in ambulant patients , although both treatments were equally well tolerated in terms of adverse effects .\
\
###23642329\
BACKGROUND	This phase III study investigated the addition of aflibercept to gemcitabine , in patients with advanced pancreatic cancer .\
METHODS	Patients with metastatic pancreatic cancer were randomly assigned to receive either intravenous ( i.v. ) aflibercept , 4 mg/kg every 2 weeks , or matching placebo combined with gemcitabine , 1000 mg/m ( 2 ) i.v. weekly for 7 weeks out of 8 , then weekly for 3 weeks out of 4 until progressive disease , unacceptable toxicity or withdrawal of consent .\
METHODS	The primary objective was to demonstrate an improvement in overall survival ( OS ) between the treatment arms .\
RESULTS	The study was stopped for futility following a planned interim analysis of OS in 427 randomised patients .\
RESULTS	With a median follow-up of 7.9 months , based on the 546 patients at study termination , median OS was 7.8 months in the gemcitabine plus placebo arm ( n = 275 ) versus 6.5 months in the gemcitabine plus aflibercept arm ( n = 271 ) , which was not significant ( hazard ratio 1.165 , 95 % confidence interval ( CI ) 0.921-1 .473 , p = 0.2034 ) .\
RESULTS	Median progression-free survival was 3.7 months in both arms .\
RESULTS	Treatment discontinuations due to adverse events were more frequent in the aflibercept than in the placebo-containing arm ( 23 % versus 12 % ) .\
CONCLUSIONS	Adding aflibercept to gemcitabine did not improve OS in patients with metastatic pancreatic cancer .\
\
###20007824\
OBJECTIVE	To study associations of small , hard macular drusen and peripheral drusen with genotypes associated with age-related macular degeneration ( AMD ) .\
METHODS	Digital grayscale fundus photographs recorded in red-free illumination were graded for the presence of drusen in 1107 subjects aged 30 to 66 years .\
METHODS	Participants were genotyped for AMD-related polymorphisms in complement factor H ( CFH ) , in LOC387715 , and in complement factor B ( CFB ) .\
RESULTS	The prevalence of 20 or more small , hard macular drusen per eye was 14 % , with no association to the investigated polymorphisms .\
RESULTS	Peripheral drusen were associated with CFHY402H ( odds ratio [ OR ] , 4.3 ; 95 % confidence interval [ 95 % CI ] , 1.4-13 , for CC versus TT genotypes ) as was macular drusen > 63 microm ( OR , 1.9 ; 95 % CI , 1.1-3 .1 , for CC versus TT genotypes ) .\
RESULTS	Macular drusen > 63 microm were associated with the presence of 20 or more small , hard macular drusen ( OR , 1.7 ; 95 % CI , 1.1-2 .6 ) and with peripheral drusen ( OR , 2.5 ; 95 % CI,1.2-5 .4 )\
CONCLUSIONS	In this study , the presence of 20 or more small , hard macular drusen per eye was not associated with known AMD-related polymorphisms , whereas the study confirmed an association of peripheral drusen with CFHY402H .\
CONCLUSIONS	( ClinicalTrials.gov number , NCT00289237 ) .\
\
###23465178\
OBJECTIVE	To determine the impact of the European Randomized Study of Screening for Prostate Cancer ( ERSPC ) publication in 2009 on prostate-specific antigen ( PSA ) level testing by Dutch general practitioners ( GPs ) in men aged 40 years .\
METHODS	Retrospective study with a Dutch insurance company database ( containing PSA test claims ) and a large district hospital-laboratory database ( containing PSA-test results ) .\
METHODS	The difference in primary PSA-testing rate as well as follow-up testing before and after the ERSPC was tested using the chi-square test with statistical significance at P < 0.05 .\
RESULTS	Decline in PSA tests 4 months after ERSPC publication , especially for men aged 60 years .\
RESULTS	Primary testing as well as follow-up testing decreased , both for PSA levels of < 4ng/mL as well as for PSA levels of 4-10ng / mL .\
RESULTS	Follow-up testing after a PSA level result of > 10ng/mL moderately increased ( P = 0.171 ) .\
RESULTS	Referral to a urologist after a PSA level result of > 4ng/mL decreased slightly after the ERSPC publication ( P = 0.044 ) .\
CONCLUSIONS	After the ERSPC publication primary PSA testing as well as follow-up testing decreased .\
CONCLUSIONS	Follow-up testing seemed not to be adequate after an abnormal PSA result .\
CONCLUSIONS	The reasons for this remain unclear .\
\
###25643851\
OBJECTIVE	To determine the initial efficacy of a mailed screening and brief intervention to reduce at-risk drinking in persons aged 50 and older .\
METHODS	Pilot randomized controlled trial .\
METHODS	University of California at Los Angeles Department of Medicine Community Offices and Primary Care Network .\
METHODS	Individuals aged 50 and older who were identified as at-risk drinkers according to the Comorbidity Alcohol Risk Evaluation Tool ( CARET ) ( N = 86 ) .\
METHODS	Participants were assigned randomly to receive personalized mailed feedback outlining their specific risks associated with alcohol use , an educational booklet on alcohol and aging , and the National Institutes of Health Rethinking Drinking : Alcohol and Your Health booklet ( intervention group ) or nothing ( control group ) .\
METHODS	Alcohol-related assessments at baseline and 3 months ; CARET-assessed at-risk drinking , number of risks , and types of risks .\
RESULTS	At 3 months , fewer intervention group participants than controls were at-risk drinkers ( 66 % vs 88 % ) , binge drinking ( 45 % vs 68 % ) , using alcohol with a medical or psychiatric condition ( 3 % vs 17 % ) , or having symptoms of such a condition ( 29 % vs 49 % ) .\
CONCLUSIONS	A brief mailed intervention may be an effective approach to intervening with at-risk drinkers aged 50 and older .\
\
###19174719\
OBJECTIVE	To determine whether the extensiveness of diabetic macular edema using a 10-step scale based on optical coherence tomography explains pretreatment variation in visual acuity and predicts change in macular thickness or visual acuity after laser photocoagulation .\
METHODS	Three hundred twenty-three eyes from a randomized clinical trial of two methods of laser photocoagulation for diabetic macular edema were studied .\
METHODS	Baseline number of thickened optical coherence tomography subfields was used to characterize diabetic macular edema on a 10-step scale from 0 to 9 .\
METHODS	Associations were explored between baseline number of thickened subfields and baseline fundus photographic variables , visual acuity , central subfield mean thickness ( CSMT ) , and total macular volume .\
METHODS	Associations were also examined between baseline number of thickened subfields and changes in visual acuity , CSMT , and total macular volume at 3.5 and 12 months after laser photocoagulation .\
RESULTS	For baseline visual acuity , the number of thickened subfields explained no more variation than did CSMT , age and fluorescein leakage .\
RESULTS	A greater number of thickened subfields was associated with a greater baseline CSMT , total macular volume , area of retinal thickening , and degree of thickening at the center of the macula ( r = 0.64 , 0.77 , 0.61-0 .63 , and 0.45 , respectively ) and with a lower baseline visual acuity ( r = 0.38 ) .\
RESULTS	Baseline number of thickened subfields showed no association with change in visual acuity ( r < or = 0.01-0 .08 ) and weak associations with change in CSMT and total macular volume ( r from 0.11 to 0.35 ) .\
CONCLUSIONS	This optical coherence tomography based assessment of the extensiveness of diabetic macular edema did not explain additional variation in baseline visual acuity above that explained by other known important variables nor predict changes in macular thickness or visual acuity after laser photocoagulation .\
\
###25156340\
BACKGROUND	Coronary artery disease is highly prevalent in patients with stroke , but because revascularization does not improve major clinical outcomes in patients with stable coronary artery disease relative to intensive medical therapy , routine evaluation for this disease is not warranted in stroke patients .\
BACKGROUND	However , it might be warranted in patients destined to undergo vigorous physical therapy .\
BACKGROUND	The Locomotor Experience Applied Post-Stroke study , a randomized controlled trial of 408 participants that tested the relative efficacy of two rehabilitation techniques on functional walking level , provided the opportunity to address this question .\
OBJECTIVE	The study aims to test the efficacy of screening for cardiovascular disease and an exercise tolerance test in assuring safety among patients undergoing vigorous rehabilitation for gait impairment .\
METHODS	All participants were screened for serious cardiovascular and pulmonary conditions .\
METHODS	At six-weeks poststroke , they also completed a cardiovascular screening inventory and underwent an exercise tolerance test involving bicycle ergometry .\
METHODS	Participants received 36 , 90-min sessions of a prescribed physical therapy ( three per week ) , initiated at either two-months or six-months poststroke .\
RESULTS	Twenty-nine participants were excluded on the basis of the cardiac screening questionnaire , and 15 failed the exercise tolerance test for cardiovascular reasons .\
RESULTS	No participant experienced a cardiac event during a treatment session .\
RESULTS	Two participants experienced myocardial infarctions , but continued in the trial .\
RESULTS	In three additional participants , myocardial infarctions caused or contributed to death .\
CONCLUSIONS	The combination of a negative cardiac screen and the absence of exercise tolerance test failure appeared to have a high negative predictive value for cardiac events during treatment , despite the likelihood of a high prevalence of coronary artery disease in our population .\
\
###23942245\
OBJECTIVE	The effects of bazedoxifene ( BZA ) / conjugated estrogens ( CE ) on sleep and health-related quality of life ( HRQoL ) were evaluated in nonhysterectomized postmenopausal women who were enrolled in a randomized , double-blind , placebo - and active-controlled phase 3 trial .\
METHODS	The sleep/HRQoL substudy enrolled 459 women with bothersome moderate to severe vasomotor symptoms who were randomized to BZA 20 mg/CE 0.45 mg , BZA 20 mg/CE 0.625 mg , BZA 20 mg , CE 0.45 mg/medroxyprogesterone acetate ( MPA ) 1.5 mg , or placebo for 1 year .\
METHODS	On months 3 and 12 , sleep parameters were evaluated using the Medical Outcomes Study sleep scale , and HRQoL was assessed using the Menopause-Specific Quality of Life ( MENQOL ) questionnaire .\
RESULTS	BZA/CE and CE/MPA significantly improved sleep and HRQoL compared with placebo .\
RESULTS	On month 3 , most Medical Outcomes Study sleep parameter improvements with BZA/CE and CE/MPA versus placebo were not significant .\
RESULTS	On month 12 , both BZA/CE doses and CE/MPA significantly improved time to fall asleep and sleep disturbance ( P < 0.05 vs. placebo ) ; BZA 20 mg/CE 0.625 mg and CE/MPA also showed significant improvements in sleep adequacy and sleep problem indices I and II ( P < 0.01 vs placebo ) .\
RESULTS	Both BZA/CE doses and CE/MPA significantly improved MENQOL vasomotor function score versus placebo at 3 and 12 months ( P < 0.001 ) .\
RESULTS	At 3 months , total MENQOL score was significantly improved with BZA 20 mg/CE 0.625 mg and CE/MPA versus placebo ( P < 0.05 ) ; at 12 months , both BZA/CE doses and CE/MPA showed significant improvements ( P < 0.001 ) .\
CONCLUSIONS	Symptomatic postmenopausal women who are treated with BZA/CE for 1 year demonstrate significant improvements in sleep and HRQoL , similar to women treated with CE/MPA .\
\
###14580054\
OBJECTIVE	In a randomized , placebo-controlled , double-blind trial , we compared the efficacy of oral dolasetron and ondansetron in preventing postoperative nausea and vomiting in children after various surgical operations .\
METHODS	Children were assigned randomly to one of three groups ( each contained 50 children ) to receive dolasetron 1.8 mg kg ( -1 ) or ondansetron 0.15 mg kg ( -1 ) orally , or a placebo .\
METHODS	All children received methylene blue capsules ( 10 mg ) orally as an indicator before the induction of anaesthesia .\
METHODS	Postoperatively , contamination of the mouth and the endotracheal tube by methylene blue was recorded , and postoperative nausea and vomiting was recorded for 0-1 , 1-24 and 0-24 h. Metoclopramide ( 0.1 mg kg ( -1 ) ) intravenously was used as the rescue antiemetic .\
RESULTS	In the 0-1 h period after operation , there were no differences between the groups .\
RESULTS	In the 1-24 h period , dolasetron was significantly better than placebo ( nausea 8 versus 24 % ; vomiting 4 versus 20 % ; total nausea and vomiting scores 16 versus 48 % ) .\
RESULTS	Over the 0-24 h period , both dolasetron and ondansetron were significantly better than placebo ( nausea 16 versus 26 versus 40 % ) , vomiting ( 8 versus 16 versus 30 % ) , and total nausea and vomiting scores ( 32 versus 48 versus 78 % ) .\
RESULTS	There were no significant differences between dolasetron and ondansetron .\
RESULTS	There was no important methylene blue contamination , and little use of rescue metoclopramide .\
RESULTS	There were no important adverse events .\
CONCLUSIONS	Prophylactic oral dolasetron and ondansetron were effective in reducing postoperative nausea and vomiting in children .\
\
###11485110\
OBJECTIVE	To examine whether increased sleep during viral or bacterial infections supports host defense mechanisms .\
METHODS	To test this assumption in humans , healthy male subjects were assigned either to sleep from 2300 to 0700 hours ( n = 10 ) or to stay awake through the night ( n = 10 ) .\
METHODS	In the sleeping subjects Salmonella abortus equi endotoxin ( 0.4 ng/kg ) or placebo were intravenously injected in balanced order during the first SWS episode .\
METHODS	The age-matched , sleep-deprived subjects were injected at the same time point .\
RESULTS	As expected , endotoxin significantly increased rectal temperature , the plasma levels of cortisol , tumor necrosis factor-alpha ( TNF-alpha ) , the soluble TNF receptors p55 and p75 , Interleukin ( IL ) -6 , the IL-1 receptor antagonist ( RA ) , leukocyte , and granulocyte counts in both sleeping and sleep-deprived subjects , whereas lymphocyte and monocyte counts were transiently reduced .\
RESULTS	Time courses of endotoxin-induced host responses did not differ between the sleep and sleep deprivation groups .\
RESULTS	Endotoxin did not affect the amount of nocturnal wakefulness , nonrapid-eye-movement ( NREM ) sleep , or rapid-eye-movement ( REM ) sleep across the total night compared with placebo , but significantly increased electroencephalogram-arousals ( EEG-arousals ) in stage 2 and decreased arousals in SWS .\
RESULTS	In addition , the amount of SWS , spectral EEG-delta and - theta power was increased at the beginning and at the end of the sleep period , respectively , when the degree of immune activation was relatively low .\
CONCLUSIONS	The present results support the notion that short-term sleep deprivation is unlikely to harm the immune system as far as unspecific acute responses are concerned .\
CONCLUSIONS	The effects of endotoxin on sleep in this case support prior observations that in humans , enhanced SWS and intensified NREM sleep occur when host defense activation is subtle .\
\
###15711670\
OBJECTIVE	The aim of this study is to compare the response of hepatitis C virus ( HCV ) genotype 4 with other genotypes to anti-viral treatment among Saudi patients in a prospective randomized trial .\
METHODS	The study was conducted in the Department of Hepatobiliary Sciences at King Abdul-Aziz Medical City , King Fahad National Guard Hospital , Riyadh , Kingdom of Saudi Arabia from March 1997 to January 2000 .\
METHODS	Sixty-two patients ( 33 males and 29 females ) aged > or = 18 with chronic hepatitis C not treated previously were tested for HCV genotype and randomly assigned to receive interferon ( IFN ) alfa 2b 3 million units 3 times per week alone or in combination with ribavirin 1000-1200 mg orally per day for 48 weeks .\
METHODS	All patients were monitored for safety and efficacy of the therapy at 4 week intervals during treatment and followed up for at least 24 weeks after completion of treatment .\
METHODS	The primary end point was loss of detectable HCV-RNA 24 weeks after treatment completion , defined as sustained virological response ( SVR ) .\
RESULTS	Hepatitis C virus genotype 4 was seen among ( 64.5 % ) HCV Saudi patients .\
RESULTS	Hepatitis C virus genotype 1 was the next most common ( 30.6 % ) .\
RESULTS	A SVR of 42.8 % ( 9 out of 21 ) was seen in HCV genotype 4 and 40 % ( 4 out of 10 ) among other HCV genotypes with combination therapy of IFN and ribavirin ( p > 0.1 ) .\
RESULTS	With IFN alone the sustained response rate was 15.7 % for genotype 4 and 16.6 % for other genotypes mainly genotype 1 ( p > 0.1 ) .\
CONCLUSIONS	We concluded that HCV genotype 4 is the most prevalent genotype among HCV infected Saudi patients .\
CONCLUSIONS	Genotype 1 was the next most common while genotypes 2 , 3 and 5 were least prevalent .\
CONCLUSIONS	There is no statistically significant difference in response rate of patients with HCV genotype 4 to either IFN alone or IFN plus ribavirin when compared with genotype 1 of HCV .\
\
###17326908\
OBJECTIVE	To compare the ProSeal laryngeal mask airway ( PLMA ) and the standard laryngeal mask airway ( SLMA ) for intermittent positive pressure ventilation ( IPPV ) in a randomized auto control design .\
METHODS	Fifty adult patients with American Society of Anesthesiologists ( ASA ) physical status 1-2 , scheduled for elective plastic surgery under general anesthesia were recruited .\
METHODS	After the routine intravenous anesthesia induction , the PLMA and the SLMA were inserted randomly in sequence into each patient and inflated to an intracuff pressure of 60 cm H ( 2 ) O ( 1 cm H ( 2 ) O = 0.098 kPa ) , airway seal pressure and lung ventilation satisfaction were evaluated , and fiberoptic ( FOB ) scores of the cuff anatomic position were measured .\
METHODS	The mean expired volume and the mean peak inspiratory pressure of five continuous breaths were calculated after IPPV with 10 ml/kg tidal volume was performed .\
RESULTS	Without cuff inflation , airway seal pressure was higher with the PLMA than with the SLMA ( P < 0.05 ) , and adequate or acceptable lung ventilation was obtained in 46 ( 92 % ) patients with the PLMA , but only 22 ( 44 % ) patients with the SLMA .\
RESULTS	When the air volume required to obtain an intracuff pressure of 60 cm H ( 2 ) O , adequate lung ventilation was obtained in 50 patients with the PLMA , but only 28 patients with the SLMA , and the inflation volume and sequential airway seal pressure were higher with the PLMA than with the SLMA ( both P < 0.05 ) , and the airway seal pressure with the PLMA was not less than with the SLMA in each patient .\
RESULTS	The ventilation volume was higher with the PLMA than with the SLMA , except in 2 patients .\
RESULTS	The FOB score of the cuff position was lower with the PLMA than with the SLMA ( P < 0.05 ) .\
RESULTS	The mean expired tidal volume and the mean peak inspiratory pressure were not significantly different between 29 patients with the PLMA and 21 patients with the SLMA for airway maintenance during operation ( both P > 0.05 ) .\
CONCLUSIONS	Compared with SLMA , PLMA can achieve a higher airway seal pressure and potentially isolate the glottis and the upper esophagus , and is safer and more effective for positive pressure ventilation .\
\
###20451663\
OBJECTIVE	Patients with moderate to severe Crohn 's disease who receive infliximab may experience secondary failure ( loss of response and/or hypersensitivity ) .\
OBJECTIVE	Data on the utility of switching to certolizumab pegol in these patients are limited .\
METHODS	A total of 539 patients with active Crohn 's disease and secondary failure to infliximab were enrolled in a 26-week trial .\
METHODS	Patients received open-label induction with subcutaneous certolizumab pegol 400 mg at weeks 0 , 2 , and 4 .\
METHODS	Those in clinical response at week 6 were randomized to certolizumab pegol 400 mg every 2 or every 4 weeks through week 24 .\
METHODS	The primary end point was response at week 6 .\
METHODS	Secondary end points included remission at week 6 and response and remission at week 26 .\
RESULTS	At week 6 , 334 of 539 patients ( 62.0 % ) achieved response and 212 of 539 ( 39.3 % ) achieved remission .\
RESULTS	A total of 329 patients were randomized and received maintenance therapy .\
RESULTS	At week 26 , 39.9 % ( 67 of 168 ) and 36.6 % ( 59 of 161 ) of patients in the every-4-weeks and every-2-weeks groups were in clinical response , respectively ( P = .55 ) .\
RESULTS	Corresponding remission rates at week 26 were 29.2 % and 30.4 % , respectively ( P = .81 ) .\
RESULTS	Serious infections occurred in 9 of 539 ( 1.7 % ) and 12 of 373 ( 3.2 % ) of patients during induction and maintenance , respectively .\
RESULTS	A single malignancy ( skin carcinoma ) occurred in a patient receiving every-4-weeks maintenance therapy .\
CONCLUSIONS	Response to open-label induction therapy with certolizumab pegol was achieved by 62 % of patients with moderate to severely active Crohn 's disease and secondary failure to infliximab .\
CONCLUSIONS	Among these patients , certolizumab pegol 400 mg every 4 weeks showed similar efficacy to every-2-weeks dosing for maintenance of response and remission .\
\
###23594808\
OBJECTIVE	In recent years cross-linked polyethylenes have been developed in an attempt to reduce the wear , as has been demonstrated in knee simulators .\
OBJECTIVE	The aim is to assess , by counting particles of polyethylene in synovial fluid , whether the reduction in wear is confirmed in patients with a highly crosslinked polyethylene prosthesis .\
METHODS	A prospective randomised study was designed .\
METHODS	During the implantation of a knee prosthesis , one group of patients was assigned the use of a conventional polyethylene ( group A ) , and the other group a highly crosslinked polyethylene ( X3 , Stryker Orthopaedics ) ( group B ) .\
METHODS	At 12 months after surgery a knee arthrocentesis was performed , and the number of polyethylene particles was counted in a scanning electron microscopy .\
METHODS	Fourteen samples from each group were studied .\
RESULTS	Both groups were comparable in all study variables .\
RESULTS	We found no significant differences in the concentration of polyethylene particles/ml ( 1.49 0.85 million in group A vs 1.42 0.91 million in group B , P = .60 ) or the total number of isolated particles .\
RESULTS	We found no differences either in size or morphology of particles between both groups .\
CONCLUSIONS	Although several in vitro studies in vitro using different types of highly crosslinked polyethylene found a significant reduction , we did not find that that wear was reduced in the knees of these patients .\
CONCLUSIONS	The great variability in the number of particles between individuals suggests that polyethylene wear in vivo depends on many factors , so perhaps the type of polyethylene is not the most significant factor .\
\
###15313884\
OBJECTIVE	To estimate the protection against death provided by vaccination against influenza .\
METHODS	Prospective cohort follow up supplemented by weekly national counts of influenza confirmed in the community .\
METHODS	Primary care .\
METHODS	24,535 patients aged over 75 years from 73 general practices in Great Britain .\
METHODS	Death .\
RESULTS	In unvaccinated members of the cohort daily all cause mortality was strongly associated with an index of influenza circulating in the population ( mortality ratio 1.16 , 95 % confidence interval 1.04 to 1.29 at 90th centile of circulating influenza ) .\
RESULTS	The association was strongest for respiratory deaths but was also present for cardiovascular deaths .\
RESULTS	In contrast , in vaccinated people mortality from any cause was not associated with circulating influenza .\
RESULTS	The difference in patterns between vaccinated and unvaccinated people could not easily be due to chance ( P = 0.02 , all causes ) .\
CONCLUSIONS	This study , using a novel and robust approach to control for confounding , provides robust evidence of a protective effect on mortality of vaccination against influenza .\
\
###16688562\
OBJECTIVE	To analyse the prospect of memory training for patients with organic brain damage .\
METHODS	Sixty-two patients with memory disorder were assigned to three different groups : a control group ( n = 16 ) with low dose memory training , a process oriented memory training group ( POT ) ( n = 24 ) and a group ( ST ) who was taught to compensate for memory problems with different strategies ( n = 22 ) .\
METHODS	Most of the patients had suffered a stroke .\
METHODS	Inclusion criteria were medium to weak memory impairment defined by the patients ' performance in the California Verbal Learning Test .\
METHODS	Patients with complete amnesia were excluded .\
METHODS	Specific care was taken that the groups did not differ in age , time since illness , duration of rehabilitation effort , verbal and performance IQ , memory and attention performance .\
METHODS	The two treatment groups received 20 hours memory training , the low dose memory training control group 7 sessions .\
RESULTS	The treatment groups improved in verbal and prospective memory , but only the group with POT experienced a significant improvement compared with the control group .\
RESULTS	Training effects were specific , i. e. they affected verbal memory , but were not encapsulated , i. e. generalized to the recall of prose passages and of appointments .\
RESULTS	The POT group also showed a statistically weak outperformance compared with the ST group and some attentional improvement as well .\
CONCLUSIONS	Memory training is effective in patients with organic brain lesion , but only if applied frequently .\
CONCLUSIONS	Comparing the two training high intensity treatments , a POT focus seems to be superior to teaching a set of compensation strategies .\
\
###15028938\
OBJECTIVE	Vaginal acidification has been suggested as a means of normalizing the vaginal flora .\
OBJECTIVE	The purpose of this study was to determine the effectiveness of an acetic acid-based vaginal gel in the treatment of bacterial vaginosis ( BV ) .\
METHODS	Forty-four patients with BV were enrolled in a randomized , double-blind clinic trial .\
METHODS	Of these , 29 were evaluable .\
METHODS	Patients were randomized to receive either 5 mL acetic acid gel ( n = 14 ) or placebo gel ( n = 15 ) intravaginally twice daily for 7 days .\
METHODS	Clinical criteria and vaginal Gram stain scores were compared between the initial visit and at 2 weeks after initiating therapy .\
RESULTS	No significant differences were noted when comparing drug and placebo in terms of subjective or clinical improvement or improvement in Gram stain smears for bacterial vaginosis .\
CONCLUSIONS	Vaginal acidification with an acetic acid gel formulated to pH 3.9 to 4.1 was ineffective therapy for bacterial vaginosis .\
\
###22494864\
BACKGROUND	Excessive myocardial triglyceride ( MTG ) content in obesity and type 2 diabetes is associated with impaired cardiac function .\
BACKGROUND	Previous studies suggest that MTG could be mobilized through lifestyle interventions .\
BACKGROUND	We assessed influences of moderate dietary weight loss in non diabetic obese and overweight women on MTG content and cardiac function .\
METHODS	We selected a subgroup of 38 women from the B-SMART study population .\
METHODS	The B-SMART study compared weight loss and associated metabolic and cardiovascular markers with reduced-carbohydrate and reduced-fat hypocaloric diets .\
METHODS	Selected subjects had completed a cardiac magnetic resonance ( MR ) scan including imaging and proton spectroscopy to assess cardiac structure and function as well as MTG content .\
RESULTS	An average weight reduction of 5.4 4.3 kg at six months was associated with a relative decrease of MTG of 25 % ( from 0.72 0.29 % at baseline to 0.54 0.23 % at follow-up , p < 0.001 ) .\
RESULTS	The response was similar with carbohydrate and fat restriction .\
RESULTS	Diastolic function expressed as ratio of peak filling rate in E - and A-Phase ( PFRE/PFRA ) was unchanged .\
RESULTS	Reductions of left atrial size ( from 21.9 4.0 cm ( 2 ) to 20.0 3.7 cm ( 2 ) , p = 0.002 ) , the normalized ratio of PFRE and early diastolic lengthening velocity PLV ( from 8.2 2.6 to 7.5 2.5 , p < 0.001 ) and fat free mass ( from 55.1 6.9 kg to 52.7 6.5 kg , p = 0.007 ) reflected altered cardiac volume loading after diet , but did not correlate to MTG content .\
CONCLUSIONS	Moderate dietary weight loss significantly reduced MTG content in women with uncomplicated overweight or obesity .\
CONCLUSIONS	Macronutrient composition of the diet did not significantly affect the extent of MTG reduction .\
\
###8598838\
BACKGROUND	In patients with human immunodeficiency virus ( HIV ) infection , combined treatment with several agents may increase the effectiveness of antiviral therapy .\
BACKGROUND	We studied the safety and efficacy of saquinavir , an HIV-protease inhibitor , given with one or two nucleoside antiretroviral agents , as compared with the safety and efficacy of a combination of two nucleosides alone .\
METHODS	In this double-blind trial , patients with HIV infection were randomly assigned to receive either saquinavir ( 1800 mg per day ) plus both zidovudine ( 600 mg per day ) and zalcitabine ( 2.25 mg per day ) or zidovudine plus either saquinavir or zalcitabine .\
METHODS	The 302 patients enrolled had CD4 + counts of 50 to 300 cells per cubic millimeter and had previously received zidovudine for a median of 27 months .\
METHODS	The study lasted 24 weeks , with an optional double-blind extension period of an additional 12 to 32 weeks .\
RESULTS	Ninety-six percent of the patients completed the 24-week study .\
RESULTS	In all three treatment groups , CD4 + cell counts rose at first and then fell gradually .\
RESULTS	The normalized area under the curve for the CD4 + count was greater with the three-drug combination than with either saquinavir and zidovudine ( P = 0.017 ) or zalcitabine and zidovudine ( P < 0.001 ) .\
RESULTS	There were significantly greater reductions in plasma HIV with the three-drug combination than with the other regimens when peripheral-blood mononuclear cells were cultured for HIV and HIV RNA was assessed , and there were greater decreases in serum neopterin and beta2-microglobulin levels .\
RESULTS	There were no major differences in toxic effects among the three treatments .\
CONCLUSIONS	Treatment with saquinavir , zalcitabine , and zidovudine was well tolerated .\
CONCLUSIONS	This drug combination reduced HIV-1 replication , increased CD4 + cell counts , and decreased levels of activation markers in serum more than did treatment with zidovudine and either saquinavir or zalcitabine .\
CONCLUSIONS	Studies are warranted to evaluate whether the three-drug combination will reduce morbidity and mortality .\
\
###8996143\
OBJECTIVE	To compare the neurotoxicity and ototoxicity of combination cisplatin plus paclitaxel versus cisplatin plus cyclophosphamide using extensive clinical and instrumental evaluation .\
METHODS	Forty-six of 51 consecutive patients affected by-epithelial ovarian cancer seen in our institution between October 1994 and August 1995 entered the study .\
METHODS	After randomization , they were assigned to receive cisplatin 75 mg/m2 every 3 weeks associated with cyclophosphamide 750 mg/m2 ( CC group , n = 22 ) or paclitaxel 175 mg/m2 over a 3-hour infusion ( CP group , n = 24 ) .\
METHODS	Treatment was repeated six times in 43 patients and nine times in 25 .\
METHODS	Before treatment and after three , six , and nine courses of chemotherapy , patients underwent clinical and instrumental neurologic and otologic examinations .\
RESULTS	Mild sensory impairment was evident even after only three courses of both treatments and signs and symptoms were more severe at the end of treatment .\
RESULTS	On clinical grounds only , it was possible to demonstrate after six and nine courses a difference between CC and CP treatment , due to the involvement in some CP patients of pain and thermal sensory modalities .\
RESULTS	However , the overall severity of the neuropathy was similar .\
RESULTS	Audiometric parameters demonstrated a more negative outcome after treatment in CC compared with CP patients .\
RESULTS	However , the different severity of the involvement was closely correlated to this initial difference in audiologic performance .\
CONCLUSIONS	Up to nine courses of chemotherapy , the CC and CP schedules are similar in terms of severity of neurotoxicity and ototoxicity when patients are evaluated during and immediately after treatment .\
CONCLUSIONS	With the doses used in our study , these toxicities are not dose-limiting .\
CONCLUSIONS	Our results suggest that most of the toxic effects observed during the treatment were due to cisplatin .\
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###14616872\
BACKGROUND	Characterization of fatal and non-fatal reactions to food indicates that the majority of reactions are due to the ingestion of prepared foods rather than the non-processed allergen .\
BACKGROUND	In an ongoing study that used a double-blind placebo-controlled food challenge to investigate peanut allergy and clinical symptoms , the observed reaction severity in four of the first six subjects was greater than anticipated .\
BACKGROUND	We hypothesized that this was due to differences in the composition of the challenge vehicle .\
OBJECTIVE	The aim was to investigate whether the severity of observed challenge reactions would be repeated on re-challenge with a lower fat challenge vehicle .\
METHODS	Peanut-allergic subjects were re-challenged with a lower fat recipe after reacting more severely than was anticipated to an initial peanut challenge .\
METHODS	Similar challenge vehicle recipes were used , the only difference being the lower fat content ( 22.9 % compared with 31.5 % ) .\
METHODS	The peanut content of the two recipes was analysed using RAST inhibition studies and ELISA tests .\
RESULTS	Three of four subjects reacted to much smaller doses of peanut protein on re-challenge ( mean dose equivalence - 23 times less peanut ) with the lower fat recipe .\
RESULTS	RAST inhibition showed that neither recipe altered epitope recognition .\
RESULTS	The higher fat recipe required twice as much peanut to cause 50 % inhibition .\
RESULTS	ELISA detected far lower levels of peanut in the higher fat recipe ( 220 000 parts per million ( p.p.m. ) ) than in the lower fat recipe ( 990 000 p.p.m. ) .\
CONCLUSIONS	The fat content of a challenge vehicle has a profound effect on the reaction experienced after allergen ingestion .\
CONCLUSIONS	This is another factor to be considered in assessing the risk of certain foods to food-allergic consumers and adds another dimension to clinical , research and regulatory practice .\
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###14636798\
BACKGROUND	Despite the availability of an increasing array of empirically validated adolescent drug abuse prevention programs , program materials and evaluation findings are poorly disseminated .\
BACKGROUND	CD-ROM and the Internet hold promise for disseminating this information to schools and agencies that directly serve youth , and to policy-making bodies that exercise control over funds to support adolescent drug abuse prevention programming .\
BACKGROUND	However , data on the relative efficacy of these newer technologies over conventional print means of dissemination are lacking .\
METHODS	Recruited through schools , community agencies , and policy-making bodies , 188 professionals were randomized to receive prevention program materials via pamphlets ( 55 participants ) , CD-ROM ( 64 participants ) , and the Internet ( 69 participants ) .\
METHODS	Participants completed pretest , posttest , and 6-month follow-up measures that assessed their access to prevention program materials ; self-efficacy for identifying , obtaining , and recommending these programs ; and their likelihood of requesting , implementing , and recommending prevention programs to their constituents .\
RESULTS	Participants exposed to dissemination via CD-ROM and the Internet evidenced the greatest short - and long-term gains on accessibility , self-efficacy , and behavioral intention variables .\
CONCLUSIONS	CD-ROM and the Internet are viable means for disseminating adolescent drug abuse prevention programs to schools , community agencies , and policy-making bodies , and should be increasingly used for dissemination purposes .\
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###20087310\
OBJECTIVE	It has been shown by many authors that proprioception declines with age .\
OBJECTIVE	However , few studies have examined the effects of exercise interventions on proprioception .\
OBJECTIVE	The purpose of this study was to investigate the effects of a creative dance program on proprioception of older adults .\
METHODS	Thirty-seven men and women between 55 and 80 years of age , who were not engaged in any exercise program for at least one year , were randomly assigned to an experimental ( 63.6 + or - 5.7 years ) or a control group ( 65.3 + or - 7.6 years ) .\
METHODS	The experimental group participated in a creative dance program for 12 weeks with a periodicity of 3 sessions of 90 minutes per week .\
METHODS	Measures of knee kinesthesia , knee joint position sense and arm positioning were taken before and after the program .\
RESULTS	After 12 weeks , knee joint position sense ( P = 0.005 ) knee kinesthesia ( in flexion ) ( P = 0.04 ) , and arm positioning ( P = 0.008 ) significantly improved within the creative dance training group .\
RESULTS	At 12 weeks follow-up , arm positioning performance was significantly better for the creative dance group when compared with the control group ( P = 0.043 ) .\
RESULTS	The control group did not show any significant improvement in proprioception .\
CONCLUSIONS	This study showed that a creative dance program emphasising body awareness can improve proprioception in older adults .\
\
###22795519\
OBJECTIVE	Risk prediction is important in medical management , especially to optimize patient management before surgical intervention .\
OBJECTIVE	No quantitative risk scores or predictors are available for patients with peripheral arterial disease ( PAD ) .\
OBJECTIVE	Surgical risk and prognosis are usually based on anesthetic scores or clinical evaluation .\
OBJECTIVE	We suggest that renal function is a better predictor of risk than other cardiovascular parameters .\
OBJECTIVE	This study used the four-variable Modification of Diet in Renal Disease ( MDRD-4 ) - calculated glomerular filtration rate ( GFR ) to compare classical cardiovascular risk factors with prognosis and cardiovascular events of hospitalized PAD patients .\
METHODS	The study evaluated 204 patients who were admitted for vascular intervention and diagnosed with grade IIb , III , or IV PAD or with carotid or renal stenosis .\
METHODS	Those with carotid or renal stenosis were excluded , leaving 188 patients who were randomized from 2004 to 2005 and monitored until 2010 .\
METHODS	We performed a life-table analysis with a 6-year follow-up period and one final checkpoint .\
METHODS	The following risk factors were evaluated : age , sex , ischemic heart disease , ictus ( as a manifestation of cerebrovascular disease related to systemic arterial disease ) , diabetes , arterial hypertension , dyslipidemia , smoking , chronic obstructive pulmonary disease , type of vascular intervention , and urea and creatinine plasma levels .\
METHODS	The GFR was calculated using the MDRD-4 equation .\
METHODS	Death , major cardiovascular events , and reintervention for arterial disease were recorded during the follow-up .\
RESULTS	Patients ( 73 % men ) were a mean age of 71.38 11.43 ( standard deviation ) years .\
RESULTS	PAD grade IIb was diagnosed in 41 ( 20 % ) and grade III-IV in 147 ( 72 % ) .\
RESULTS	Forty-two minor amputations ( 20.6 % ) , 21 major amputations ( 10.3 % ) , and 102 revascularizations ( 50 % ) were performed .\
RESULTS	A major cardiovascular event occurred in 60 patients ( 29.4 % ) , and 71 ( 34.8 % ) died .\
RESULTS	Multivariate logistic regression analysis showed that the MDRD-4 GFR , age , and male sex were independent variables related to death and that the MDRD-4 GFR and chronic obstructive pulmonary disease were related to major cardiovascular events .\
RESULTS	A statistically significant relationship was also found between serum creatinine levels and reintervention rates .\
CONCLUSIONS	The MDRD-4 GFR was a better predictor of risk of death or infarction than classical cardiovascular risk factors in patients with PAD .\
CONCLUSIONS	This suggests that its routine use in the initial evaluation in patients with PAD is beneficial .\
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###12502976\
BACKGROUND	Propofol is reported to reduce both sympathetic and parasympathetic tone ; however , it is not clear whether the changes in heart rate variability are associated with depth of anesthesia .\
BACKGROUND	The purposes of the present study were ( 1 ) to evaluate the changes in heart rate variability at different depths of hypnosis and ( 2 ) to compare the effects of propofol on heart rate variability with that of sevoflurane .\
METHODS	Thirty patients were randomly allocated into the propofol or sevoflurane for induction of anesthesia .\
METHODS	The depth of hypnosis was monitored by the Bispectral Index ( BIS ) .\
METHODS	Spectral analysis of heart rate variability using a maximum-entropy method resulted in a characteristic power spectrum with two main regions , a high frequency ( HF ) and a low frequency ( LF ) .\
METHODS	Hemodynamics , entropy , LF , HF , and LF/HF were monitored when the patients were awake and after induction of anesthesia .\
RESULTS	Both propofol and sevoflurane decreased blood pressure in a BIS-dependent manner , whereas heart rate showed no significant changes during the study period .\
RESULTS	In the propofol group , entropy and HF decreased with a reduction in the BIS value .\
RESULTS	Although LF decreased after induction of anesthesia , propofol caused no further decrease in LF in spite of a reduction in the BIS value .\
RESULTS	In the sevoflurane group , LF decreased with a reduction in the BIS value .\
RESULTS	Entropy and HF decreased after induction of anesthesia ( BIS at 80 ) ; however , no further decreases were observed in spite of a reduction in the BIS value .\
CONCLUSIONS	Induction of anesthesia with propofol decreased blood pressure , entropy , and HF in a BIS-dependent manner , indicating that propofol reduces cardiac parasympathetic tone depending on the depth of hypnosis .\
CONCLUSIONS	Conversely , sevoflurane did not show the BIS-dependent decreases in heart rate , blood pressure , HF , and entropy , indicating that sevoflurane has little or no effect on cardiac parasympathetic tone .\
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###9869995\
BACKGROUND	A variety of factors , including the number of defibrillation electrodes and shocking capacitance , may influence the defibrillation efficacy of an implantable defibrillator system .\
BACKGROUND	Therefore , the purpose of this study was to compare the defibrillation energy requirement using a 125 uF two-electrode defibrillation system and a 90 uF three-electrode defibrillation system .\
RESULTS	The defibrillation energy requirements measured with both systems were compared in 26 consecutive patients .\
RESULTS	The two-electrode system used a single transvenous lead with two defibrillation coils in conjunction with a biphasic waveform from a 125 uF capacitor .\
RESULTS	The three-electrode system used the same transvenous lead , utilized a pectoral implantable defibrillator generator shell as a third electrode , and delivered the identical biphasic waveform from a 90 uF capacitor .\
RESULTS	The two-electrode system was associated with a higher defibrillation energy requirement ( 10.8 + / - 5.5 J ) than was the three-electrode system ( 8.9 + / - 6.7 J , p < 0.05 ) , however , the leading edge voltage was not significantly different between systems ( 361 + / - 103 V vs. 397 + / - 123 V , P = 0.07 ) .\
RESULTS	The two-electrode system also had a higher shocking resistance ( 49.0 + / - 9.0 ohms vs. 41.4 + / - 7.3 ohms , p < 0.001 ) and a lower peak current ( 7.7 + / - 2.6 A vs. 10.1 + / - 3.7 A , p < 0.001 ) than the three-electrode system .\
CONCLUSIONS	A three-electrode defibrillation system that utilizes a dual coil transvenous lead and a subcutaneous pectoral electrode with lower capacitance is associated with a lower defibrillation energy requirement than is a dual coil defibrillation system with higher capacitance .\
CONCLUSIONS	This finding suggests that the utilization of a pectoral generator as a defibrillation electrode in conjunction with smaller capacitors is a more effective defibrillation system and may allow for additional miniaturization of implantable defibrillators .\
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###25292072\
OBJECTIVE	To explore the influence of different ways of blood transfusion on the expression levels of interleukins ( IL ) and tumor necrosis factor - ( TNF - ) inperi-operative patients with esophageal cancer .\
METHODS	A total of 80 patients with esophageal cancer who underwent radical operations were selected as study patients and randomly divided into an observation group ( treated with autologous blood transfusion ) and control group ( with homologous blood transfusion ) .\
METHODS	Changes of intra-operative indexes and peri-operative blood indexes , from hemoglobin ( Hb ) and hematocrit value ( Hct ) , to levels of inflammatory factors like interleukins-6 ( IL-6 ) , IL-8 , IL-10 and tumor necrosis factor - ( TNF - ) were compared .\
RESULTS	Operations for patients in both groups were successfully conducted , and no significant differences in mean surgical duration and intra-operative hemorrhage volume , fluid infusion volume and blood transfusion volume were detected ( p > 0.05 ) .\
RESULTS	Compared with values before surgery , Hb and Hct levels decreased significantly while white blood cell count ( WBC ) increased 1 , 5 and 7 d after operation ( p < 0.05 , p < 0.01 ) .\
RESULTS	In addition , WBC was apparently higher in observation group than in control group 5 and 7 d after operation ( p < 0.01 ) .\
RESULTS	Compared with before surgery , in the observation group , levels of IL-6 , IL-8 and IL-10 had no significant differences after operation ( P > 0.05 ) , but TNF - level increased y ( p < 0.01 ) , whereas in control group , IL-6 level had no significant difference ( p > 0.05 ) , IL-8 level decreased obviously ( p < 0.05 ) , IL-10 level increased markedly first and then decreased gradually as time passed but its level remained elevated ( p < 0.01 ) , and TNF - level increased first and then decreased , and there was no significant difference 7 d after operation ( p > 0.05 ) .\
CONCLUSIONS	Decreased IL-8 and increased IL-10 levels are two important reasons forimmunosuppression after homologous blood transfusion , whereas autologous blood transfusion can alleviate this while increasing the TNF - level , which also has potential to improve anti-tumor immunity in the human body .\
\
###22972399\
OBJECTIVE	To assess the effect of low - ( 10 mg ) or high - ( 80 mg ) dose atorvastatin on carotid artery distensibility in patients with asymptomatic carotid artery disease using carotid magnetic resonance imaging .\
METHODS	Eighteen patients underwent initial 2-dimensional ECG gated-phase contrast carotid MR imaging and off-line applanation tonometry for distensibility assessment before randomisation to receive low - or high-dose statins and this was repeated at 12 weeks .\
METHODS	Phase and magnitude images from the 2-D phase contrast acquisitions were used for quantification of distensibility and compliance coefficients and were compared between the low - and high-dose statin groups .\
RESULTS	Both groups were comparable with regards to their demographics , co-morbidities and baseline cholesterol levels .\
RESULTS	After 12 weeks of high-dose statin administration , a significant decrease in LDL ( p = 0.003 ) and CRP ( p = 0.03 ) was observed .\
RESULTS	At 12 weeks , the distensibility coefficient of the common and internal carotid artery was found to be significantly higher ( with respect to baseline ) in the high-dose group ( p = 0.004 and p = 0.007 , respectively ) .\
RESULTS	The compliance coefficient was likewise found to be raised in the high-dose group when compared with the low-dose group [ common carotid ( p = 0.002 ) , internal carotid ( p = 0.009 ) ] .\
CONCLUSIONS	High-dose atorvastatin tends to reduce carotid arterial stiffness , as suggested by increased distensibility and compliance coefficients ; however , these results need validation through large-scale trials to fully establish their possible use in clinical practice .\
\
###20135168\
BACKGROUND	Postlaparoscopic shoulder pain ( PLSP ) frequently occurs after various laparoscopic surgical procedures .\
BACKGROUND	Its mechanism is commonly assumed to be overstretching of the diaphragmatic muscle fibers due to the pressure of a pneumoperitoneum , which causes phrenic nerve-mediated referred pain to the shoulder .\
BACKGROUND	Based on this hypothesis , we speculated that during inspiration , the lung could squeeze out the phrenic nerve with carbon dioxide gas against the constantly pressurized abdominal cavity with increasing tidal volume ( V ( T ) ) .\
BACKGROUND	Thus , we examined whether mechanical ventilation with a low V ( T ) ( LTV , V ( T ) 7 ml/kg ) during a pneumoperitoneum might reduce PLSP in patients undergoing laparoscopic appendectomy compared with ventilation with the traditional V ( T ) ( TTV , V ( T ) 10 ml/kg ) .\
METHODS	In a prospective trial , 64 adult patients undergoing laparoscopic appendectomy were randomly assigned to two groups of 32 each ( LTV and TTV groups ) .\
METHODS	Intravenous ketorolac was used as a postoperative rescue analgesic .\
METHODS	The 2 - , 4 - , 24 - , and 48-h postoperative incidence and severity of PLSP , severity of surgical pain , and need for rescue analgesia was assessed .\
RESULTS	The overall incidence of PLSP was similar in both groups ( 57.1 % in the LTV group vs. 65.5 % in the TTV group ) .\
RESULTS	Compared with the TTV group , the incidence and PLSP verbal rating scale ( VRS ) did not decrease in the LTV group throughout the study period .\
RESULTS	No statistically significant differences were observed in the VRS surgical pain score , the cumulative ketorolac consumption at each time point , or the time to first rescue analgesia .\
CONCLUSIONS	Mechanical ventilation with a reduced 7 ml/kg V ( T ) during a pneumoperitoneum does not reduce the frequency and severity of PLSP after laparoscopic appendectomy compared with ventilation with the traditional V ( T ) ( 10 ml/kg ) .\
\
###11080722\
BACKGROUND	Few studies have evaluated IgE-mediated hypersensitivity to melon with details of clinical reactions confirmed by double-blind , placebo-controlled , food challenges ( DBPCFCs ) .\
OBJECTIVE	We sought to investigate clinical features ( type and severity of reactions , age at onset , results of skin prick and in vitro tests , and incidence of other allergic diseases and associated food allergies ) of acute allergic reactions to melon confirmed by DBPCFCs .\
METHODS	Fifty-three consecutive adult patients complaining of adverse reactions to melon were included in the study .\
METHODS	Skin prick tests and detection of specific IgE were performed in all patients with melon , avocado , kiwi , banana , chestnut , latex , pollen , and other offending foods .\
METHODS	Patients first underwent an open food challenge , unless they had a convincing history of severe anaphylaxis .\
METHODS	Positive open food challenge reactions were subsequently evaluated by DBPCFCs .\
RESULTS	Actual clinical reactivity was confirmed in 19 ( 36 % ) of 53 patients .\
RESULTS	The most frequent symptom was oral allergy syndrome ( n = 14 ) , but two patients experienced life-threatening reactions , including respiratory symptoms and hypotension .\
RESULTS	The positive predictive value for a skin prick test was 42 % , and that for specific IgE measurement was 44 % .\
RESULTS	Forty-five reactions to 15 other foods were confirmed in 18 patients .\
RESULTS	The most common foods associated with melon allergy were avocado ( n = 7 ) , banana ( n = 7 ) , kiwi ( n = 6 ) , watermelon ( n = 6 ) , and peach ( n = 5 ) .\
RESULTS	Onset of melon-induced allergic symptoms occurred from 6 to 45 years ( median , 20 years ) , preceded by seasonal rhinitis , asthma , or both in 88 % ( 15/17 ) .\
CONCLUSIONS	About one third of reported reactions to melon are confirmed by means of DBPCFC , which has been proven to be the most reliable procedure in the diagnosis of clinical fruit allergy .\
CONCLUSIONS	Isolated melon allergy is rare , with most patients either having allergic rhinitis , asthma , or both and associated food allergies .\
\
###12565715\
BACKGROUND	Patients undergoing rehabilitation after thromboembolic stroke have a relatively high incidence of venous thromboembolism ( VTE ) .\
BACKGROUND	Warfarin , with a target international normalized ratio ( INR ) of 2.0-3 .0 is effective for the prevention of VTE .\
BACKGROUND	However , because stroke is a major risk factor for bleeding with warfarin , a less intense regimen ( target INR < 2.0 ) , might safely prevent VTE in stroke rehabilitation patients .\
METHODS	This study was a randomized , double-blind , placebo-controlled trial of 2 mg of warfarin in patients undergoing rehabilitation following completed stroke .\
METHODS	The major efficacy endpoint was symptomatic , objectively proven VTE or asymptomatic VTE detected by monthly duplex ultrasonography ( DU ) of the proximal leg veins or mandatory bilateral contrast venography performed at the end of the study .\
METHODS	The major safety endpoint was bleeding .\
RESULTS	There were 475 patients screened for enrollment , 355 had one or more exclusion criterion , and 17 had previously undetected proximal DVT on admission .\
RESULTS	Of the 103 eligible and consenting patients , 56 received warfarin and 47 received placebo .\
RESULTS	Of the randomized patients , 88 had successful venography ( 47 warfarin and 41 placebo ) .\
RESULTS	In the warfarin group , three ( 8 % ) patients had DVT and one ( 2 % ) had proximal DVT whereas in the placebo group , seven ( 20 % ) had DVT and five ( 13 % ) had proximal DVT .\
RESULTS	The risk ratio for any DVT in warfarin-treated patients relative to placebo-treated patients was 0.39 ( 95 % confidence interval ( CI ) , 0.13-1 .37 ) .\
RESULTS	For proximal DVT , the risk ratio was 0.17 ( 95 % CI , 0.01-1 .4 ) .\
RESULTS	No patients suffered major bleeding .\
CONCLUSIONS	A fixed dose of 2 mg of warfarin per day in patients undergoing stroke rehabilitation is safe and associated with a relative risk reduction of about 80 % in the incidence of proximal DVT and 60 % in overall DVT .\
\
###17407159\
BACKGROUND	Tissue inhibitors of metalloproteinase ( TIMPs ) have at least 2 different functions .\
BACKGROUND	They inhibit the catalytic activity of matrix metalloproteinases , and they act as growth factors .\
METHODS	Pretreatment ethylenediamine tetracetic acid plasma TIMP-1 was assayed from 251 patients who were enrolled in a Phase III , second-line , hormone therapy trial , and from a control group of 50 healthy , postmenopausal women by using the TIMP-1 enzyme-linked immunosorbent assay .\
RESULTS	The plasma TIMP-1 levels from the postmenopausal control group ( n = 50 women ) were 201 + / - 86 ng/mL mean + / - standard deviation ( range , 49-455 ng/mL ) .\
RESULTS	The upper limit of normal was defined as the mean + / - 2 standard deviations of the control group ( 373 ng/mL ) .\
RESULTS	Patient pretreatment plasma TIMP-1 levels ranged from 70 ng/mL to 982 ng/mL .\
RESULTS	Plasma TIMP-1 was elevated above the mean + 2 standard deviations of the control group ( 373 ng/mL ) in 19 patients ( 7.6 % ) .\
RESULTS	In univariate analysis , patients who had elevated versus normal plasma TIMP-1 levels had a reduced clinical benefit rate ( CBR ) ( 16 % vs 42 % ; P = .03 ) .\
RESULTS	The time to progression ( TTP ) ( 84 days vs 174 days ; P < .0001 ) and overall survival ( 141 days vs 860 days ; P = .0001 ) also were significantly shorter in patients who had elevated TIMP-1 levels .\
RESULTS	TTP and overall survival also were significantly shorter in patients who had higher TIMP-1 plasma levels when it was analyzed as a continuous variable .\
RESULTS	In multivariate analysis , elevated plasma TIMP-1 level remained a prognostic factor for reduced overall survival ( P < .0001 ) along with elevated serum HER-2 / neu ( P < .0001 ) and the presence of visceral metastases ( P = .008 ) .\
CONCLUSIONS	Elevated pretreatment plasma levels of TIMP-1 predicted a decreased response to second-line hormone therapy and reduced survival in women with metastatic breast cancer .\
\
###24113764\
BACKGROUND	Recent studies provide evidence for the effectiveness of Internet-based maintenance treatments for mental disorders .\
BACKGROUND	However , it is still unclear which participants might or might not profit from this particular kind of treatment delivery .\
OBJECTIVE	The study aimed to identify moderators of treatment outcome in a transdiagnostic Internet-based maintenance treatment ( TIMT ) offered to patients after inpatient psychotherapy for mental disorders in routine care .\
METHODS	Using data from a randomized controlled trial ( N = 400 ) designed to test the effectiveness of TIMT , we performed secondary analyses to identify factors moderating the effects of TIMT ( intervention ) when compared with those of a treatment-as-usual control condition .\
METHODS	TIMT involved an online self-management module , asynchronous patient-therapist communication , a peer support group , and online-based progress monitoring .\
METHODS	Participants in the control condition had unstructured access to outpatient psychotherapy , standardized outpatient face-to-face continuation treatment , and psychotropic management .\
METHODS	Self-reports of psychopathological symptoms and potential moderators were assessed at the start of inpatient treatment ( T1 ) , at discharge from inpatient treatment/start of TIMT ( T2 ) , and at 3-month ( T3 ) and 12-month follow-up ( T4 ) .\
RESULTS	Education level , positive outcome expectations , and diagnoses significantly moderated intervention versus control differences regarding changes in outcomes between T2 and T3 .\
RESULTS	Only education level moderated change differences between T2 and T4 .\
RESULTS	The effectiveness of the intervention ( vs control ) was more pronounced among participants with a low ( vs high ) education level ( T2-T3 : B = -0.32 , SE 0.16 , P = .049 ; T2-T4 : B = -0.42 , SE 0.21 , P = .049 ) , participants with high ( vs low ) positive outcome expectations ( T2-T3 : B = -0.12 , SE 0.05 , P = .02 ) and participants with anxiety disorder ( vs mood disorder ) ( T2-T3 : B = -0.43 , SE 0.21 , P = .04 ) .\
RESULTS	Simple slope analyses revealed that despite some subgroups benefiting less from the intervention than others , all subgroups still benefited significantly .\
CONCLUSIONS	This transdiagnostic Internet-based maintenance treatment might be suitable for a wide range of participants differing in various clinical , motivational , and demographic characteristics .\
CONCLUSIONS	The treatment is especially effective for participants with low education levels .\
CONCLUSIONS	These findings may generalize to other Internet-based maintenance treatments .\
\
###10073243\
BACKGROUND	Droperidol even in low doses such as 0.5 mg to 1.25 mg can increase postoperative anxiety and state of tension .\
BACKGROUND	The aim of this study was to determine whether these side effects occur frequently following low-dose droperidol and to see whether these are dose related .\
METHODS	184 female in - and outpatients ASA grade 1 and 2 undergoing gynaecological laparoscopy were recruited to this prospective , double-blind study .\
METHODS	General anaesthesia was standardized ( induction with thiopentone , fentanyl 2 micrograms/kg and vecuronium 0.1 mg/kg , tracheal intubation , maintainance with enflurane in N2O/O2 ) .\
METHODS	Patients were randomly allocated to receive saline ( n = 45 ) , 0.625 mg ( n = 46 ) , 1.25 mg ( n = 47 ) or 2.5 mg ( n = 46 ) droperidol i.v. 10 minutes before the end of surgery .\
METHODS	1,3,6 , and 24 hours postoperatively , the patients ' anxiety , state of tension and overall mood was evaluated using two psychological questionnaires which had been tested for the perioperative period ( Erlanger anxiety and tension-scale/BSKE-EWL-test ) .\
METHODS	Sedation was evaluated by the staff of the recovery room .\
METHODS	In addition , postoperative nausea and vomiting ( PONV ) was assessed using a 100 mm visual analogue scale and by counting the episodes of retching or vomiting .\
METHODS	PONV was then rated over the whole observation period as none , mild , moderate or severe using a fixed scoring algorithm .\
METHODS	Statistical analysis was performed using the ANOVA and the chi2-test .\
RESULTS	The patients did not differ with regard to biometric data , duration of surgery and anaesthesia .\
RESULTS	The postoperative scores for anxiety , state of tension and overall mood were not different between the groups at any observation time ( Fig. 1 : anxiety and tension : P = 0.5687 ; figure 2 : overall mood : P = 0.0647 ) .\
RESULTS	Quality of sleep in the first night after surgery was the same in all groups ( Table 2 and 3 ) .\
RESULTS	Sedation was not significantly different ( Table 4 ; P = 0.0704 ) .\
RESULTS	Furthermore , duration of stay in the recovery room did not differ ( P = 0.4353 ) .\
RESULTS	On the other hand , three patients from the 2.5 mg droperidol group had to stay unexpectedly on the ward overnight , because they had been too much sedated to be discharged at home .\
RESULTS	This was not the case with any patient from the other groups .\
RESULTS	Compared to placebo , PONV over the whole 24 h observation period was significantly reduced by droperidol ( Fig. 3 ; P = 0.0338 ) : completely free from PONV : placebo : 41.3 % , 0.625 mg droperidol : 67.4 % , 1.25 mg droperidol : 53.2 % , 2.5 mg droperidol : 71.7 % .\
RESULTS	Also the severity of PONV was reduced .\
CONCLUSIONS	In gynaecological laparoscopy under general anaesthesia with tracheal intubation , we recommend droperidol 0.625 mg in the prevention of PONV , as it reduces PONV as well as 2.5 mg with no severe sedation in this dosage .\
CONCLUSIONS	Psychological side effects did not occur more frequently after droperidol compared to placebo in any of the investigated dosages .\
\
###19106795\
BACKGROUND	High blood pressure ( BP ) in acute stroke patients is both common and associated with a poor outcome , although best management remains unclear .\
BACKGROUND	Particular uncertainty exists in patients with carotid stenosis in whom lowering BP might reduce cerebral perfusion and worsen outcome .\
METHODS	Efficacy of Nitric Oxide in Stroke ( ENOS ) is an international , randomized controlled trial investigating the effect of lowering BP with glyceryl trinitrate in 5000 patients with acute stroke .\
METHODS	This analysis is based on patients with ischaemic stroke for whom information on the carotid status was available .\
METHODS	Neurological impairment ( Scandinavian Stroke Scale ) and rate of recurrent stroke were assessed on day 7 , and the functional outcome ( modified Rankin score ) was determined on day 90 .\
METHODS	ENOS is ongoing , therefore analyses are blinded to treatment .\
RESULTS	At the time of analysis , 565 patients with ischaemic stroke had been randomized into ENOS and data on carotid status were available in 394 ( 70 % ) of these patients .\
RESULTS	Ipsilateral stenosis > or = 50 % was present in 50 patients ( 13 % ) .\
RESULTS	Six of 344 ( 2 % , 95 % confidence interval : 0.7 , 4 % ) patients with ipsilateral stenosis < 50 % had a recurrent stroke by 7 days as compared with none of 50 patients ( 0 % , 95 % confidence interval : 0 , 9 % ) ( P = 0.73 ) with stenosis > or = 50 % .\
RESULTS	No significant difference in impairment was present on day 7 ; mean Scandinavian Stroke Scale with stenosis 38.3 versus no stenosis 43.2 ( P = 0.48 ) .\
RESULTS	Adjusted functional outcome after 90 days was worse in those with a baseline carotid stenosis > or = 50 % ; median modified Rankin score 3.0 versus 2.0 ( P = 0.03 ) .\
CONCLUSIONS	Interim data provide reassurance that it is reasonable to continue including patients with carotid stenosis into trials of acute BP lowering ( such as ENOS ) .\
\
###17548021\
BACKGROUND	Similar to cardiac surgery patients , medical-surgical critically ill patients may benefit from intensive insulin therapy .\
BACKGROUND	The objectives of this pilot trial were to evaluate the feasibility of a randomized trial of intensive insulin therapy with respect to ( a ) achieving target glucose values in the 2 ranges of 5 to 7 and 8 to 10 mmol/L and ( b ) uncovering problems with the protocol in anticipation of a larger trial .\
METHODS	The trial was conducted in a 15-bed medical-surgical university-affiliated intensive care unit ( ICU ) .\
METHODS	We included patients older than 18 years , expected to be in ICU for more than 72 hours , with a glucose value of more than 10 mmol/L within 48 hours of ICU admission .\
METHODS	Exclusion criteria were diabetic ketoacidosis , severe hepatic failure or hepatic resection , pancreatitis , glucose of less than 2.2 mmol/L on admission to hospital , insulin infusion on admission to ICU , planned withdrawal of life support , and inability to obtain informed consent .\
METHODS	Patients underwent concealed random allocation to a target glucose range of 5 to 7 or 8 to 10 mmol/L using pretested algorithms of insulin infusions .\
METHODS	Dedicated glucometer measurement of arterial glucose values was calibrated daily to values measured in the laboratory .\
RESULTS	We enrolled 20 patients with a mean ( SD ) Acute Physiology and Chronic Health Evaluation ( APACHE ) II score of 32 ( 10.2 ) ; 14 were insulin-dependent pre-ICU , and all were medical admissions .\
RESULTS	Mean glucose values were different in the 2 groups ( 7.1 + / - 2.6 vs 9.4 + / - 2.1 mmol/L , P < .001 ) .\
RESULTS	Although the intensive insulin therapy group had more glucose measurements performed than the control group , a similar proportion of values were within the target range ( 682 [ 42.4 % ] of 1607 values in the 5 - to 7-mmol/L range ; 250 [ 38.7 % ] of 660 values in the 8 - to 10-mmol/L range , P = .35 ) .\
RESULTS	Glucose values of less than 2.5 mmol/L developed 7 times in 5 patients , 4 of whom were in the intensive insulin therapy group ; however , no adverse consequences were documented .\
RESULTS	As expected , there were no differences in clinically important outcomes .\
CONCLUSIONS	In this pilot trial of ICU patients with high illness severity , glucose values were in the 2 target ranges only 40 % of the time , using well-accepted initiation and maintenance insulin infusion algorithms .\
CONCLUSIONS	A large randomized trial of glycemic control is feasible in this population to examine clinically important outcomes , but will require refined insulin algorithms and more comprehensive behavior change strategies to achieve target values .\
\
###8773636\
OBJECTIVE	To test the hypothesis that treatment with human parathyroid hormone 1-34 ( PTH 1-34 ) can maintain normal serum calcium without hypercalciuria in patients with hypoparathyroidism .\
METHODS	Randomized crossover trial lasting 20 weeks .\
METHODS	Each 10-week arm consisted of a 2-week inpatient dose-adjustment phase followed by an 8-week outpatient phase .\
METHODS	Tertiary care center .\
METHODS	A total of 10 patients with hypoparathyroidism were enrolled consecutively over a 15-month period .\
METHODS	Half of the patients were prior National Institutes of Health patients , and the other 5 patients were referred from outside physicians .\
METHODS	A dose of PTH 1-34 was administered each morning by subcutaneous injection .\
METHODS	Calcitriol was given orally twice daily with supplemental calcium carbonate .\
METHODS	Serum and urine calcium and phosphorus levels .\
RESULTS	Once-daily treatment with PTH 1-34 maintained serum calcium in the normal range with decreased urine calcium excretion ( P < .05 at 2 weeks and P < .\
RESULTS	Ol at 10 weeks ) compared with calcitriol treatment .\
RESULTS	Biochemical markers of bone turnover increased significantly ( P < .\
RESULTS	Ol at 10 weeks ) during PTH 1-34 treatment .\
CONCLUSIONS	Treatment of hypoparathyroidism with PTH 1-34 reduces urine calcium excretion compared with treatment with calcitriol and calcium .\
\
###23766396\
BACKGROUND	Infants with very low birth weight ( VLBW ) are at increased risk for motor deficits , which may be reduced by early intervention programs .\
BACKGROUND	For detection of motor deficits and to monitor intervention , different assessment tools are available .\
BACKGROUND	It is important to choose tools that are sensitive to evaluate the efficacy of intervention on motor outcome .\
OBJECTIVE	The purpose of this study was to compare the Alberta Infant Motor Scale ( AIMS ) and the Psychomotor Developmental Index ( PDI ) of the Bayley Scales of Infant Development-Dutch Second Edition ( BSID-II-NL ) in their ability to evaluate effects of an early intervention , provided by pediatric physical therapists , on motor development in infants with VLBW at 12 months corrected age ( CA ) .\
METHODS	This was a secondary study in which data collected from a randomized controlled trial ( RCT ) were used .\
METHODS	At 12 months CA , 116 of 176 infants with VLBW participating in an RCT on the effect of the Infant Behavioral Assessment and Intervention Program were assessed with both the AIMS and the PDI .\
METHODS	Intervention effects on the AIMS and PDI were compared .\
RESULTS	Corrected for baseline differences , significant intervention effects were found for AIMS and PDI scores .\
RESULTS	The highest effect size was for the AIMS subscale sit .\
RESULTS	A significant reduction of abnormal motor development in the intervention group was found only with the AIMS .\
CONCLUSIONS	No Dutch norms are available for the AIMS .\
CONCLUSIONS	The responsiveness of the AIMS to detect intervention effects was better than that of the PDI .\
CONCLUSIONS	Therefore , caution is recommended in monitoring infants with VLBW only with the PDI , and the use of both the AIMS and the Bayley Scales of Infant Development is advised when evaluating intervention effects on motor development at 12 months CA .\
\
###9352700\
OBJECTIVE	To compare the efficacy and safety of a fixed dose ( 0.2 mg ) of tamsulosin , a selective alpha 1A-adrenoreceptor antagonist , with an increasing dose ( 1-5 mg ) of terazosin , a non-selective antagonist , in the treatment of urinary outflow obstruction associated with benign prostatic hyperplasia ( BPH ) in Korean patients .\
METHODS	The study comprised a single-blind and randomized design with tamsulosin or terazosin taken once daily for 8 weeks .\
METHODS	A total of 98 patients was enrolled , with 72 patients included in the analyses after 4 and 8 weeks .\
METHODS	The primary variables assessed were changes in the maximum urinary flow rate Qmax and the total International Prostate Symptom Score ( IPSS ) , with the post-void residual urine volume , ` obstructive ' and ` irritative ' questions in the IPSS , and the investigators ' global assessment of efficacy also determined .\
METHODS	The number of patients with a clinically significant response to treatment with tamsulosin or terazosin was determined and defined as those with > 20 % improvement from the baseline Qmax or > 20 % decrease in total IPSS .\
METHODS	Adverse reactions possibly or probably related to study medication were recorded throughout the treatment period .\
RESULTS	Both tamsulosin and terazosin produced similar significant improvements in subjective and objective symptoms of urinary outflow obstruction ( P > 0.05 ) .\
RESULTS	Systolic and diastolic ( standing ) blood pressures decreased significantly in patients treated with terazosin ( P < 0.05 ) .\
RESULTS	The adverse reactions , most frequently dry mouth and dizziness which were usually mild and transient , were significantly higher in patients on terazosin ( 18 patients , versus one on tamsulosin , P < 0.001 ) .\
RESULTS	The changes led to discontinuation of therapy in two patients on terazosin .\
CONCLUSIONS	Tamsulosin was as effective as terazosin in treating urinary outflow obstruction associated with BPH , but had a markedly better safety profile .\
\
###10699773\
BACKGROUND	Pulse oximetry , used to monitor oxygen saturation during endoscopy , does not directly measure hypoventilation .\
BACKGROUND	Study goals were to determine whether transcutaneous carbon dioxide ( PtcCO ( 2 ) ) monitoring during endoscopic retrograde cholangiopancreatography ( ERCP ) prevents severe hypoventilation and to assess the accuracy of clinical observation and pulse oximetry in detecting hypoventilation .\
METHODS	All patients received intensive clinical and electronic monitoring including pulse oximetry .\
METHODS	Supplemental oxygen was administered for pulse oximetry < 90 % .\
METHODS	Patients were randomized to a treatment arm ( group 1 ) where PtcCO ( 2 ) monitoring guided sedation or a control arm ( group 2 ) where PtcCO ( 2 ) was recorded but unavailable for guiding sedation .\
RESULTS	Group 1 had significantly fewer episodes of severe carbon dioxide retention ( rise in PtcCO ( 2 ) > / = 40 mm Hg above baseline ) than group 2 ( 0 of 199 versus 5 of 196 , respectively , p = 0.03 ) , as well a shorter mean duration of procedure discomfort ( 8.3 % of procedure duration rated as `` uncomfortable '' versus 11.5 % , p = 0.04 ) .\
RESULTS	Correlations between clinical observation and objective measures of ventilation were poor : level of sedation versus PtcCO ( 2 ) ( R = 0.3 ) or pulse oximetry ( R = 0.06 ) ; slowest respiratory rate versus PtcCO ( 2 ) ( R = 0.4 ) or pulse oximetry ( R = -0.4 ) .\
RESULTS	PtcCO ( 2 ) rises of greater than 20 mm Hg occurred without oxygen desaturation in 10.7 % of patients receiving supplemental oxygen .\
CONCLUSIONS	Carbon dioxide retention during ERCP is not reliably detected by clinical observation or by pulse oximetry in patients receiving supplemental oxygen .\
CONCLUSIONS	The addition of PtcCO ( 2 ) monitoring prevents severe carbon dioxide retention more effectively than intensive clinical monitoring and pulse oximetry alone .\
CONCLUSIONS	The clinical relevancy of this observation needs to be determined in an appropriately designed outcome study .\
\
###18296926\
OBJECTIVE	Relationships between intraocular pressure ( IOP ) and baseline characteristics are explored in a subgroup of children participating in the Correction of Myopia Evaluation Trial .\
OBJECTIVE	The 5-year follow-up also provides information on the relationship between IOP , myopic progression , and change in axial length .\
METHODS	Right eye IOP , cycloplegic autorefraction , and axial length were measured at baseline and annually in 104/118 children at one of the Correction of Myopia Evaluation Trial centers .\
RESULTS	At baseline , IOP for the cohort was 15.92 + / - 4.16 mm Hg .\
RESULTS	IOP decreased ( 0.125 mm Hg/year ) over the follow-up ( p = 0.05 ) .\
RESULTS	IOP of Blacks ( n = 17 ; 19.88 + / - 4.24 mm Hg ) was higher than Hispanics ( n = 50 ; 15.77 + / - 2.44 mm Hg , p = 0.006 ) , Whites ( n = 25 ; 14.51 + / - 1.75 mm Hg , p = 0.0001 ) and all non-Blacks combined ( n = 87 ; 15.38 + / - 2.26 mm Hg , p = 0.0006 ) .\
RESULTS	IOP averaged over the six visits did not differ by gender ( mean difference = 0.66 mm Hg ) .\
RESULTS	There was no significant association between baseline IOP and baseline myopia or myopic progression , and no significant relationship between IOP the year prior to myopic progression measured over the following year .\
RESULTS	The same results were found for IOP and axial length .\
CONCLUSIONS	Small but significant ethnic differences were noted in the IOP of myopic children , with Blacks having higher values .\
CONCLUSIONS	IOP was not associated with gender , baseline refractive error , baseline axial length , myopic progression , or change in axial length over the 5-year observation period .\
\
###14570295\
OBJECTIVE	To explore public attitudes toward the incorporation of cost-effectiveness analysis into clinical decisions .\
METHODS	The authors presented 781 jurors with a survey describing 1 of 6 clinical encounters in which a physician has to choose between cancer screening tests .\
METHODS	They provided cost-effectiveness data for all tests , and in each scenario , the most effective test was more expensive .\
METHODS	They instructed respondents to imagine that he or she was the physician in the scenario and asked them to choose which test to recommend and then explain their choice in an open-ended manner .\
METHODS	The authors then qualitatively analyzed the responses by identifying themes and developed a coding scheme .\
METHODS	Two authors separately coded the statements with high overall agreement ( kappa = 0.76 ) .\
METHODS	Categories were not mutually exclusive .\
RESULTS	Overall , 410 respondents ( 55 % ) chose the most expensive option , and 332 respondents ( 45 % ) choose a less expensive option .\
RESULTS	Explanatory comments were given by 82 % respondents .\
RESULTS	Respondents who chose the most expensive test focused on the increased benefit ( without directly acknowledging the additional cost ) ( 39 % ) , a general belief that life is more important than money ( 22 % ) , the significance of cancer risk for the patient in the scenario ( 20 % ) , the belief that the benefit of the test was worth the additional cost ( 8 % ) , and personal anecdotes/preferences ( 6 % ) .\
RESULTS	Of the respondents who chose the less expensive test , 40 % indicated that they did not believe that the patient in the scenario was at significant risk for cancer , 13 % indicated that they thought the less expensive test was adequate or not meaningfully different from the more expensive test , 12 % thought the cost of the test was not worth the additional benefit , 9 % indicated that the test was too expensive ( without mention of additional benefit ) , and 7 % responded that resources were limited .\
CONCLUSIONS	Public response to cost-quality tradeoffs is mixed .\
CONCLUSIONS	Although some respondents justified their decision based on the cost-effectiveness information provided , many focused instead on specific features of the scenario or on general beliefs about whether cost should be incorporated into clinical decisions .\
\
###15379051\
BACKGROUND	A WHO experts committee recommended the substitution of antirabic vaccines produced in nervous tissue , by vaccines produced in tissue cultures .\
OBJECTIVE	To compare the immunogenic capacity of antirabic vaccines CRL ( produced in nervous tissue ) and Verorab ( produced in tissue culture ) , used for pre-exposure prophylaxis in humans .\
METHODS	Fifty four volunteers were immunized for this study .\
METHODS	The first group , vaccinated with CLR was treated with a scheme of 4 subcutaneous peri umbilical doses in days 0 , 3 , 7 and 28 .\
METHODS	The second group , vaccinated with Verorab vaccine was treated with a scheme of 3 intramuscular doses in deltoid zone at days 0 , 7 and 28 .\
METHODS	Blood samples were obtained at days 0 , 7 , 42 and 365 to measure neutralizing antibodies using the Inhibition of Fluorescent Focus Technique ( RFFIT ) .\
RESULTS	At day seven , a primary non protective immunologic response was observed in both groups , with titers significantly higher in the group vaccinated with Verorab .\
RESULTS	At day 42 , no differences were observed .\
RESULTS	At day 365 , all subjects vaccinated with Verorab and 50 % of individuals vaccinated with CRL had protective antibody titers ( p < 0.05 ) .\
CONCLUSIONS	The vaccine produced in cell breeds ( Verorab ) produces a better an faster immunologic response compared to the CRL vaccine .\
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###17267841\
OBJECTIVE	To evaluate the relationship between fetal fibronectin and preterm birth and maternal-to-child transmission of human immunodeficiency virus ( HIV ) in an African population of predominantly HIV-infected women .\
METHODS	During a trial of second trimester and intrapartum antibiotics compared with placebo to prevent chorioamnionitis and reduce preterm birth and mother-to-child transmission of HIV , vaginal fluid was collected before antibiotics ( 20-24 weeks ) and after treatment at 28 weeks and assayed for fetal fibronectin .\
METHODS	Pregnancy outcomes of 2,353 women delivering liveborn singleton infants are presented .\
RESULTS	Positive fetal fibronectin assays ( 50 ng/mL or more ) were detected in 4.2 % and 4.9 % of samples at 20-24 weeks and 28 weeks .\
RESULTS	Positive fetal fibronectin assays at 28 weeks but not at 20-24 weeks were associated with lower mean birthweight ( 199 g , P < .001 ) ; lower mean gestational age ( 2 weeks , P < .001 ) ; six-fold higher rate of preterm birth less than 32 weeks ( 10.8 % compared with 1.9 % , odds ratio 6.3 , 95 % confidence interval 3.2-12 .3 ) and a two-fold higher rate of preterm birth less than 37 weeks ( 38.7 compared with 22.0 % , odds ratio 2.3 , 95 % confidence interval 1.5-3 .3 ) .\
RESULTS	Also , at 28 weeks , as the fetal fibronectin values increased , each of the outcomes worsened , and every test of trend was significant .\
RESULTS	An association between elevated fetal fibronectin levels and mother-to-child transmission of HIV was present at 20 to 24 weeks but not at 28 weeks .\
RESULTS	Antibiotic treatment at 20 to 24 weeks was not associated with fetal fibronectin levels at 28 weeks .\
CONCLUSIONS	In a population of predominantly HIV - infected African women , fetal fibronectin concentrations at 28 but not at 20-24 weeks were associated with increased risk of preterm birth .\
CONCLUSIONS	The associations were stronger for early preterm birth and when fetal fibronectin levels were higher .\
CONCLUSIONS	High levels of fetal fibronectin were positively associated with mother-to-child transmission of HIV at 20 -24 but not at 28 weeks .\
CONCLUSIONS	Antibiotic treatment did not influence fetal fibronectin levels .\
BACKGROUND	www.clinicalTrials.gov , NCT00021671\
METHODS	I.\
\
###19439084\
BACKGROUND	To reduce the duration of sick leave and loss of productivity due to common mental disorders ( CMDs ) , we developed a return-to-work programme to be provided by occupational physicians ( OPs ) based on the principles of exposure in vivo ( RTW-E programme ) .\
BACKGROUND	This study evaluates this programme 's effectiveness and cost-effectiveness by comparing it with care as usual ( CAU ) .\
BACKGROUND	The three research questions we have are : 1 ) Is an RTW-E programme more effective in reducing the sick leave of employees with common mental disorders , compared with care as usual ?\
BACKGROUND	2 ) Is an RTW-E programme more effective in reducing sick leave for employees with anxiety disorders compared with employees with other common mental disorders ?\
BACKGROUND	3 ) From a societal perspective , is an RTW-E programme cost-effective compared with care as usual ?\
METHODS	This study was designed as a pragmatic cluster-randomized controlled trial with a one-year follow-up and randomization on the level of OPs .\
METHODS	We aimed for 60 OPs in order to include 200 patients .\
METHODS	Patients in the intervention group received the RTW-E programme .\
METHODS	Patients in the control group received care as usual .\
METHODS	Eligible patients had been on sick leave due to common mental disorders for at least two weeks and no longer than eight weeks .\
METHODS	As primary outcome measures , we calculated the time until full return to work and the duration of sick leave .\
METHODS	Secondary outcome measures were time until partial return to work , prevalence rate of sick leave at 3 , 6 , 9 , and 12 months ' follow-up , and scores of symptoms of distress , anxiety , depression , somatization , and fatigue ; work capacity ; perceived working conditions ; self-efficacy for return to work ; coping behaviour ; avoidance behaviour ; patient satisfaction ; and work adaptations .\
METHODS	As process measures , we used indices of compliance with the intervention in the intervention group and employee-supervisor communication in both groups .\
METHODS	Economic costs were calculated from a societal perspective .\
METHODS	The total costs consisted of the costs of consuming health care , costs of production loss due to sick leave and reduced productivity , and out-of-pocket costs of patients for travelling to their OP .\
CONCLUSIONS	The results will be published in 2009 .\
CONCLUSIONS	The strengths and weaknesses of the study protocol are discussed .\
BACKGROUND	ISRCTN72643128 .\
\
###18633013\
BACKGROUND	Antifibrinolytic drugs including aprotinin and tranexamic acid are currently used in cardiac surgery to reduce postoperative bleeding and transfusion requirements , and may have different effects on platelets .\
BACKGROUND	We therefore evaluated platelet function after cardiopulmonary bypass ( CPB ) and cardiac surgery to determine the effect of either aprotinin or tranexamic acid .\
METHODS	In a prospective , randomized study , 50 patients scheduled for elective cardiac surgery with CPB were evaluated .\
METHODS	Patients received high-dose aprotinin ( n = 25 ) or tranexamic acid ( n = 25 ) as antifibrinolytic drugs .\
METHODS	Coagulation and platelet function were assessed preoperatively , after CPB , 3 and 24 h after surgery using modified thrombelastography and whole blood aggregometry .\
RESULTS	Impaired coagulation after CPB occurred in both groups compared with preoperative data ( P < 0.01 ) .\
RESULTS	In contrast to modified thrombelastography , thrombin receptor-mediated aggregometry after CPB was significantly decreased only in those patients receiving tranexamic acid until the end of the study period in comparison to the aprotinin group ( P < 0.05 ) .\
RESULTS	Aprotinin-treated patients showed significantly less chest tube drainage ( 575 mL + / - 228 vs 1033 mL + / - 647 , P < 0.05 ) and need for postoperative transfusion requirements ( P < 0.01 ) compared with the tranexamic acid group .\
CONCLUSIONS	Platelet function measured by whole blood aggregometry is better preserved by aprotinin than tranexamic acid and may be responsible for producing less bleeding within the first 24 h after CPB .\
\
###8439024\
BACKGROUND	Intravenous opioids often are used as a component of anesthesia during neurosurgical procedures .\
BACKGROUND	However , the cerebrovascular effects of alfentanil administered to patients are controversial .\
BACKGROUND	In this study , the effect of alfentanil in patients with and without intracranial pathology was studied .\
METHODS	Sixteen neurosurgical patients and 16 patients scheduled for orthopedic procedures were studied .\
METHODS	Anesthesia was maintained with isoflurane ( 0.4-0 .6 vol % inspired ) and nitrous oxide ( 50 % ) in oxygen .\
METHODS	Within each group , the patients were assigned randomly to receive either 25 or 50 micrograms/kg intravenous alfentanil .\
METHODS	During normocapnia and without surgical stimulation , the right middle cerebral artery flow velocity , and mean arterial pressure were measured every minute for 10 min after the administration of alfentanil .\
METHODS	In the neurosurgical patients , intracranial pressure , cerebral perfusion pressure , and cerebral arteriovenous oxygen content difference were determined also .\
METHODS	Neurosurgical patients received intravenous phenylephrine to maintain mean arterial pressure as needed .\
RESULTS	There was no significant change in middle cerebral artery flow velocity and arteriovenous oxygen content difference in the neurosurgical patients .\
RESULTS	In the high-dose group , intracranial pressure increased by 2 mmHg at 4 min but was otherwise unchanged .\
RESULTS	Despite phenylephrine administration , there was an immediate but transient decrease in mean arterial pressure in the high-dose group and a corresponding decrease in cerebral perfusion pressure .\
RESULTS	In the orthopedic patients , mean arterial pressure decreased significantly .\
RESULTS	Middle cerebral artery flow velocity decreased in the high-dose group but remained unchanged in the low-dose group .\
CONCLUSIONS	Based on the flow velocity and metabolic data , alfentanil is neither a cerebral vasodilator nor a vasoconstrictor in these doses .\
CONCLUSIONS	Furthermore , there was no clinically significant increase in intracranial pressure when alfentanil was administered in either dose .\
\
###15789954\
OBJECTIVE	To determine the effectiveness of dental health care services in facilitating recovery from quality of life decrements in symptom-specific subgroups with the most prevalent chronic infectious diseases ( periodontal disease and dental caries ) , and a ` stained teeth ' subgroup .\
METHODS	Data were taken from the prospective longitudinal Florida Dental Care Study of 873 individuals 45 + years old .\
METHODS	Logistic regression modeling quantified associations between recovery from oral health-related quality of life decrements ( ` recovery ' ) and dental services .\
RESULTS	Adjusting for age , race , gender , income , approach to dental care , and signs/symptoms , any dental visit ( odds ratio , OR : 4.0 ; 95 % confidence interval , CI : 2.3 , 6.9 ) , corrective treatment ( OR : 3.8 ; 95 % CI : 1.6 , 8.7 ) , denture visit ( OR :4.8 ; 95 % CI : 1.1 , 21.9 ) , or extraction ( OR : 6.2 ; 95 % CI : 2.2 , 17.4 ) were positively associated with recovery .\
RESULTS	Upon conditioning the analyses on specific symptoms , point estimates increased substantially for most service types , and dental cleaning was associated with recovery for the stained teeth subgroup ( OR : 10.9 ; 95 % CI : 1.2 , 99.4 ) .\
CONCLUSIONS	Dental care was highly effective in treating quality of life decrements .\
CONCLUSIONS	Treatment effectiveness increased substantially when analyses were restricted to symptom-specific subgroups similar to selection criteria of randomized clinical trials ( RCTs ) .\
CONCLUSIONS	Restricted cohort analyses can be applied to many other health outcomes for which RCTs are not feasible or ethical .\
\
###8303575\
OBJECTIVE	Various types of fractionation schemes have been tried in recent year with the objective of improving tumor control rate because conventional fractionation schedules do not always produce optimum results .\
OBJECTIVE	To compare the radiobiological effectiveness and the gain in the therapeutic ratio due to various fractionation schemes , empirical formulae such as NSD , TDF , CRE and TSD were introduced and used despite of many short comings .\
OBJECTIVE	Recent linear quadratic ( LQ ) model is claimed to be able to predict the radiobiological responses of tumor as well as normal tissues more accurately .\
OBJECTIVE	In the present study various empirical models are compared .\
METHODS	We treated malignancy of cervix uteri by twice daily fractionation schedules of 1.2 Gy/fraction , 1.4 Gy/fraction and 1.6 Gy/fraction with interfraction interval of four to six hours .\
METHODS	The percentage tumor regression was estimated from weekly clinical observations and the TDFt , TSD and ERDt concepts were applied to the data and the predictions are compared .\
RESULTS	It was observed that TDFt and TSD concepts predicts equally well ( within + / - 3 % ) the probable tumor regression as predicted by LQ concept .\
CONCLUSIONS	Till precise values of various parameters of LQ model are known , the TDF and TSD models can be used to predict probable tumor control rates within reasonable accuracy .\
\
###12003257\
OBJECTIVE	In this randomized double-blind placebo-controlled cross-over study the effects of spreads enriched with plant sterols were determined on serum lipids , lipoprotein and apolipoprotein concentrations in a Belgian population .\
METHODS	Fourty-two healthy adult volunteers ( 22 men and 20 women ) with an average age of 55 ( SD 9 ) years and with serum total cholesterol concentrations below 300 mg/dl , consumed during two consecutive periods of 4 weeks two different low-fat spreads .\
METHODS	Both the plant sterol rich and control spreads contained 35 % of fat and had an almost equal fat composition .\
METHODS	The sterol content of the enriched spread was 8.3 % .\
METHODS	Intake of the spreads was 25 g/day .\
RESULTS	Serum total and LDL-cholesterol concentrations lowered by 7 % ( 18 mg/dl ) and 10 % ( 16 mg/dl ) , respectively , with the plant sterol-enriched compared to the control spread .\
RESULTS	Serum HDL-cholesterol concentration did not significantly differ between the two spreads .\
RESULTS	Apolipoprotein B concentrations lowered by 8 % ( 0.08 g/l ) with the plant sterol-enriched spread , while concentrations of apolipoprotein A-I did not change .\
CONCLUSIONS	These findings indicate that a daily intake of 25 gram low-fat spread containing 2 gram plant sterol per day is effective in lowering blood total and LDL cholesterol , and apolipoprotein B concentrations .\
CONCLUSIONS	This lowering may help to reduce the risk of heart disease in the population .\
\
###18191734\
OBJECTIVE	The purpose of this study was to define the pre-operative angiographic variables that could influence graft patency and flow pattern .\
BACKGROUND	Saphenous vein grafts ( SVG ) and pedicled right gastroepiploic artery ( RGEA ) grafts are routinely used to revascularize the right coronary artery ( RCA ) .\
BACKGROUND	Little is known about the predictive value of objective pre-operative angiographic parameters on the 6-month graft patency and on the interest of these parameters to select the optimal graft material in individual cases .\
METHODS	We prospectively enrolled 172 consecutive patient candidates for coronary revascularization .\
METHODS	Revascularization of the RCA was randomly performed with SVG in 82 patients or with the RGEA in 90 patients .\
METHODS	Both groups were comparable with respect to all pre-operative continuous and discrete variable and risk factors .\
METHODS	All patients underwent a systematic angiographic control 6 months after surgery .\
METHODS	Pre-operative angiographic parameters included minimal lumen diameter ( MLD ) , percent stenosis and reference diameter of the RCA measured by quantitative angiography ( CAAS II system , Pie Medical , Maastricht , the Netherlands ) , location of the stenosis , run off of the RCA , and regional wall motion of the revascularized territory .\
RESULTS	A significant difference in the distribution of flow patterns was observed between SVG and RGEA .\
RESULTS	In multivariate analysis , graft-dependent flow pattern was significantly associated with both MLD and percent stenosis of the RCA in the RGEA group but with percent stenosis only in the SVG group .\
RESULTS	In the RGEA group , the proportion of patent grafts was higher when MLD was below a threshold value lying in the third MLD quartile ( 0.77 to 1.40 mm ) .\
CONCLUSIONS	Pre-operative angiography predicts graft patency in RGEA , whereas the flow pattern in SVG is significantly less influenced by quantitative angiographic parameters .\
\
###15933313\
BACKGROUND	The conventional view that participants in randomised controlled trials sacrifice themselves for the good of future patients is challenged by increasing evidence to suggest that individual patients benefit from participation in trials .\
OBJECTIVE	To test the hypothesis that trial participants receive higher quality care and , as a consequence , have better outcomes than patients receiving guideline driven routine care .\
METHODS	Retrospective comparative study of 408 women with pre-eclampsia all managed according to a strict protocol .\
METHODS	Trial participants were 86 women who participated in a multicentre randomised controlled trial of magnesium sulphate for the treatment of pre-eclampsia ( Magpie Trial ) ; 322 non-participants formed the control group .\
METHODS	Indicators of the process of care and clinical outcomes were compared between the two groups .\
RESULTS	Trial participants were significantly more likely to have received daily blood tests ( odds ratio ( OR ) 6.82 , 95 % CI 1.62 to 28.72 ) and had their respiration rate measured hourly ( OR 3.42 , 95 % CI 1.69 to 6.92 ) than control patients .\
RESULTS	There were no significant differences in other markers of clinical process and no significant difference in clinical outcomes .\
CONCLUSIONS	This study shows minor differences in process markers and no difference in clinical outcomes between patients in a clinical trial and patients receiving protocol driven care .\
CONCLUSIONS	The benefits of improved clinical care that have previously been associated with being in a trial may be explained by the use of clear clinical protocols .\
CONCLUSIONS	In routine practice , patients may be well advised to insist on treatment as part of a protocol .\
\
###11992180\
BACKGROUND	Several clinical trials have established the benefit of using a topical corticosteroid in conjunction with tazarotene gel in the treatment of plaque psoriasis .\
BACKGROUND	However , there is little information comparing the relative benefits of different corticosteroids , or different formulations of corticosteroids , when used adjunctively with tazarotene .\
OBJECTIVE	This study was designed to compare the clinical benefits achieved with each of six commonly prescribed high - or mid-high-potency corticosteroid creams and ointments applied in conjunction with tazarotene 0.1 % gel in the treatment of patients with stable plaque psoriasis .\
METHODS	A 12-week , multicenter , investigator-masked , randomized , parallel-group study was performed with more than 200 patients who were randomly assigned to regimens of tazarotene 0.1 % gel alone , tazarotene plus a high-potency topical corticosteroid ( fluocinonide 0.05 % ointment , mometasone furoate 0.1 % ointment , or diflorasone diacetate 0.05 % ointment ) , or tazarotene plus a mid-high-potency topical corticosteroid ( betamethasone dipropionate 0.05 % cream , fluticasone propionate 0.005 % ointment , or diflorasone diacetate 0.05 % cream ) .\
METHODS	All medications were to be applied once daily : corticosteroids in the morning , tazarotene gel in the evening .\
METHODS	At assessment visits , physicians made an overall evaluation of the patient 's psoriasis and graded global improvement , plaque elevation , scaling , erythema , and pruritus .\
METHODS	Patients also rated their treatment in terms of efficacy , tolerability , and satisfaction .\
RESULTS	The best-performing steroid was betamethasone dipropionate 0.05 % cream ( a mid-high-potency steroid ) , followed by mometasone furoate 0.1 % ointment ( a high-potency steroid ) and diflorasone diacetate 0.05 % ointment ( a high-potency steroid ) .\
RESULTS	Maximum improvements were achieved within 8 weeks .\
RESULTS	The best-tolerated regimen was tazarotene plus mometasone furoate 0.1 % ointment and the optimal balance between efficacy and tolerability was achieved with this regimen .\
CONCLUSIONS	Some steroids are considerably more effective than others in optimizing the efficacy and tolerability of tazarotene therapy .\
CONCLUSIONS	With a suitable combination regimen , the duration of initial therapy ( before maintenance therapy is started ) need not be prolonged .\
\
###25257928\
BACKGROUND	Clustering of outcomes at centers involved in multicenter trials is a type of center effect .\
BACKGROUND	The Consolidated Standards of Reporting Trials Statement recommends that multicenter randomized controlled trials ( RCTs ) should account for center effects in their analysis , however most do not .\
BACKGROUND	The Early External Cephalic Version ( EECV ) trials published in 2003 and 2011 stratified by center at randomization , but did not account for center in the analyses , and due to the nature of the intervention and number of centers , may have been prone to center effects .\
BACKGROUND	Using data from the EECV trials , we undertook an empirical study to compare various statistical approaches to account for center effect while estimating the impact of external cephalic version timing ( early or delayed ) on the outcomes of cesarean section , preterm birth , and non-cephalic presentation at the time of birth .\
METHODS	The data from the EECV pilot trial and the EECV2 trial were merged into one dataset .\
METHODS	Fisher 's exact method was used to test the overall effect of external cephalic version timing unadjusted for center effects .\
METHODS	Seven statistical models that accounted for center effects were applied to the data .\
METHODS	The models included : i ) the Mantel-Haenszel test , ii ) logistic regression with fixed center effect and fixed treatment effect , iii ) center-size weighted and iv ) un-weighted logistic regression with fixed center effect and fixed treatment-by-center interaction , iv ) logistic regression with random center effect and fixed treatment effect , v ) logistic regression with random center effect and random treatment-by-center interaction , and vi ) generalized estimating equations .\
RESULTS	For each of the three outcomes of interest approaches to account for center effect did not alter the overall findings of the trial .\
RESULTS	The results were similar for the majority of the methods used to adjust for center , illustrating the robustness of the findings .\
CONCLUSIONS	Despite literature that suggests center effect can change the estimate of effect in multicenter trials , this empirical study does not show a difference in the outcomes of the EECV trials when accounting for center effect .\
BACKGROUND	The EECV2 trial was registered on 30 July 30 2005 with Current Controlled Trials : ISRCTN 56498577 .\
\
###16096324\
BACKGROUND	In patients with ultrasound-visible hydrosalpinges , salpingectomy prior to IVF increases the chance of a live birth .\
BACKGROUND	This study compared the cost-effectiveness of this strategy ( intervention ) with that of optional salpingectomy after a failed cycle ( control ) .\
METHODS	Data from a Scandinavian randomized controlled trial were used to calculate the individual number of treatments and their outcomes .\
METHODS	Only patients with ultrasound-visible hydrosalpinges were considered in the main analysis , and a maximum of three fresh cycles were included .\
METHODS	The costs for surgical procedures , IVF treatment , medication , complications , management of pregnancy and delivery as well as of early pregnancy losses were calculated from standardized hospital charges .\
RESULTS	Among the 51 patients in the intervention group , the live birth rate was 60.8 % compared with 40.9 % in 44 controls .\
RESULTS	The average cost per patient was 13,943 euro and 12,091 euro , respectively .\
RESULTS	Thus , the average cost per live birth was 22,823 euro in the intervention group and 29,517 euro in the control group .\
RESULTS	The incremental cost-effectiveness ratio for adopting the intervention strategy was estimated at 9306 euro .\
CONCLUSIONS	The incremental cost to achieve the higher birth rate of the intervention strategy seems reasonable .\
\
###24014042\
OBJECTIVE	The aim of this study was to investigate the strength and role of therapeutic alliance in a trial comparing Cognitive Behavioral Therapy for anorexia nervosa ( CBT-AN ) and Specialist Supportive Clinical Management for the treatment of severe and enduring AN ( SE-AN ) .\
METHODS	Participants were 63 adult females with SE-AN presenting to an outpatient , multisite randomized controlled trial conducted at two clinical sites .\
METHODS	Participants completed measures assessing their perception of the quality of the therapeutic relationship , eating disorder ( ED ) symptomatology , and depressive symptomatology .\
RESULTS	Beyond the effect of early treatment change and treatment assignment , early therapeutic alliance was a significant predictor of Restraint and Shape Concern at follow-up ( ps < .02 ) .\
RESULTS	Late therapeutic alliance was a significant predictor of weight change , depressive symptomatology , and ED symptomatology at end of treatment and follow-up ( ps < .008 ) , with the exception of Shape Concern at follow-up ( p = .07 ) .\
CONCLUSIONS	The results suggest that therapeutic alliance can be effectively established in the treatment of SE-AN and may be relevant for treatment response , particularly in late treatment , on some aspects of ED and depressive symptomatology .\
\
###15629618\
OBJECTIVE	Radiation therapy for head-and-neck cancer requires a reliable immobilization for an accurate and consistent treatment setup .\
OBJECTIVE	This prospective , randomized study was done to compare two types of Posicast thermoplastic face masks , in terms of reproducibility , patient comfort , tolerability , and skin damage .\
METHODS	The patients were randomly assigned to use a head mask ( HM ) or a head-and-shoulder mask ( HSM ) .\
METHODS	Three-dimensional treatment planning was followed by fractionated external-beam radiation therapy .\
METHODS	Reproducibility was assessed by comparing port films with simulator films twice during treatment and by comparing actual treatment table positions weekly .\
METHODS	Patient tolerability and comfort were studied weekly .\
METHODS	The radiation-induced skin damage was assessed every week according to the World Health Organization toxicity scale .\
RESULTS	A total of 260 patients were included , and 241 ( 93 % ) were evaluated .\
RESULTS	There were no statistically significant differences between the groups ( HM or HSM ) in terms of reproducibility .\
RESULTS	Patients using HSM experienced significantly more claustrophobia ( p = 0.023 ) .\
RESULTS	Patients allocated to HSM receiving > or = 60 Gy were found to have more skin reactions .\
CONCLUSIONS	The smaller HM reduced feelings of claustrophobia , as well as skin reactions , for patients receiving > or = 60 Gy .\
CONCLUSIONS	The smaller mask did not compromise the reproducibility of the setup .\
\
###17674020\
BACKGROUND	The objective of the study was to analyze optical coherence tomography ( OCT ) scan differences between patients with predominantly classic subfoveal choroidal neovascularization ( CNV ) secondary to age-related macular degeneration ( AMD ) treated with only photodynamic therapy ( PDT ) and patients treated with PDT combined with intravitreal triamcinolone acetonide ( IVTA ) .\
METHODS	In this prospective study , 61 patients were randomized to receive PDT ( n = 30 ) or PDT combined with IVTA ( n = 31 ) .\
METHODS	They were evaluated every 3 months with a refraction protocol for best-corrected visual acuity ( VA ) measured with Early Treatment Diabetic Retinopathy Study ( ETDRS ) charts , fluorescein angiography ( FA ) , and OCT. .\
METHODS	When measuring foveal thickness on OCT scans , neuroretinal foveal thickness ( NFT ) was differentiated from outer high reflectivity band thickness ( OHRBT ) .\
METHODS	The main outcome measures were mean change in OCT measurements and correlation of VA and angiographic area of the lesion with OCT measurements .\
RESULTS	At the 12-month follow-up , the mean change in NFT was not significantly reduced ( P = 0.9 ) , but the mean change in OHRBT was significantly lower ( P = 0.004 ) in the group of patients who received combined therapy .\
RESULTS	There was no correlation between final VA and NFT in either patient group ( P = 0.2 ) .\
RESULTS	The final VA was significantly worse in eyes with a thicker OHRBT ( P = 0.04 ) in the group of patients treated with only PDT .\
RESULTS	There was no correlation between angiographic area and NFT and OHRBT in either patient group ( P > 0.3 ) .\
RESULTS	There was a statistically significant difference between the pre-treatment angiographic area of the lesion and VA at the 12-month follow-up in the combined therapy group ( P = 0.01 ) , and more eyes treated with only PDT presented with intraretinal fluid at the last follow-up ( P = 0.01 ) .\
CONCLUSIONS	Combined PDT+IVTA therapy was more effective than PDT alone at reducing OHRBT .\
CONCLUSIONS	This OCT measurement seems to be have a greater effect on VA than NFT .\
\
###20561645\
OBJECTIVE	The clinical benefit of sacral neuromodulation is unclear due to the paucity of randomized trial data .\
OBJECTIVE	The purpose of this study was to evaluate sacral neuromodulation for management of urinary and fecal incontinence in a pediatric population .\
METHODS	This multicenter , open label , randomized , crossover study included children older than 5 years .\
METHODS	After trial stimulation of the S3 root a neuromodulator ( InterStim ) was implanted on the S3 foramen .\
METHODS	Clinical examinations , voiding and bowel diaries , and urodynamic and manometric evaluations were performed at the beginning ( t1 ) and end ( t2 ) of the first period , and at the beginning ( t3 ) and end ( t4 ) of the second period .\
RESULTS	A total of 33 patients ( 24 boys ) with a mean + / - SD age of 12.22 + / - 5.09 years were randomized .\
RESULTS	Etiologies were mainly of neurological origin .\
RESULTS	Incontinence was mixed urinary and fecal in 19 cases , urinary only in 9 and fecal only in 5 .\
RESULTS	Cystometric bladder capacity increased during sacral neuromodulation ( delta +24.27 ml vs -37.45 ml , p = 0.01 ) .\
RESULTS	There was no significant change in other urodynamic or manometric parameters .\
RESULTS	Overall positive response rate was more than 75 % for urinary ( 81 % ) and bowel ( 78 % ) function .\
RESULTS	Crossover analysis indicated that sacral neuromodulation is more effective than conservative treatment for both types of incontinence ( p = 0.001 ) .\
CONCLUSIONS	In a pediatric population sacral neuromodulation is effective for bladder and bowel dysfunction and should be considered before irreversible surgery .\
\
###16762579\
OBJECTIVE	To assess the immunogenicity of a fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b ( DTaP-IPV-Hib ) conjugate vaccine compared to DTaP-IPV and lyophilized Hib conjugate vaccines given simultaneously at separate sites as a three-dose primary vaccination in Taiwanese infants .\
METHODS	Two hundred infants were randomized to receive either DTaP-IPV-Hib or DTaP-IPV plus Hib vaccine at 2 , 4 , and 6 months of age .\
METHODS	Both combined vaccines contained the same five pertussis antigens : pertussis toxoid ( PT ) , filamentous hemagglutinin ( FHA ) , pertactin ( PRN ) , fimbriae 2 and 3 ( FIM 2 & 3 ) .\
METHODS	Antibody concentrations were measured before the first and after the third dose .\
METHODS	Reactogenicity was evaluated from parental reports .\
METHODS	All subjects received hepatitis B vaccine at 0 , 1 , and 6 months of age following the national vaccination schedule of Taiwan .\
RESULTS	The immunogenicity after the third dose was high for each vaccine antigen in both groups , and the vaccines had low reactogenicity .\
RESULTS	Statistical analysis showed no differences in the immune responses to the fully liquid DTaP-IPV-Hib vaccine compared with those to the DTaP-IPV plus Hib control vaccines , notably the anti-PRP ( polyribose ribitol phosphate capsular polysaccharide ) response , with 97-99 % of infants having concentrations > or = 1.0 microg/mL .\
RESULTS	Approximately 95 % of all infants developed seroprotective levels of anti-hepatitis B surface antigen ( HBs ) antibodies ( > or = 10 mIU/mL ) .\
CONCLUSIONS	Both combination vaccines had similar high immunogenicity for each antigen , and both were well tolerated .\
CONCLUSIONS	Thus , inclusion of a Haemophilus influenzae type b conjugate vaccine in the combination did not result in clinically significant decrease in the PRP response or increase reactogenicity .\
CONCLUSIONS	The fully liquid pentavalent vaccine has the advantages of not requiring reconstitution and of administration as a single injection .\
\
###11352437\
OBJECTIVE	Moxifloxacin is a new 8-methoxyfluoroquinolone with a broad antibacterial spectrum .\
OBJECTIVE	The purpose of the present study was to determine the effects of age and gender on pharmacokinetics , surrogate pharmacodynamics , safety and tolerability of a single dose of moxifloxacin .\
METHODS	This was a randomised , double-blind , placebo-controlled , parallel-group single dose trial in young and elderly healthy volunteers .\
METHODS	The study included 36 volunteers in 3 age and gender groups : young males ( mean age 32 years ) , elderly males ( mean age 74 years ) , and elderly females ( mean age 74 years ) .\
METHODS	Participants received either a single 200mg oral dose of moxifloxacin ( 8/group ) or placebo ( 4/group ) .\
METHODS	Blood samples for moxifloxacin pharmacokinetics were obtained before and up to 48 hours after administration .\
METHODS	Urine samples were collected for pharmacokinetics , and volunteers were monitored for clinical adverse events and laboratory abnormalities .\
RESULTS	Maximum plasma concentration ( Cmax ) and area under the plasma concentration-time curve ( AUC ) were higher in elderly females than in elderly males ; however , when normalised for bodyweight , these pharmacokinetic parameters were not significantly different between the groups .\
RESULTS	Moreover , the plasma pharmacokinetics in elderly males were not meaningfully different from those in young males .\
RESULTS	Elimination half-life averaged 12 to 13 hours for the 3 groups .\
RESULTS	Surrogate pharmacodynamic measures were derived using AUC/MIC ( minimal inhibitory concentration ) and Cmax/MIC ratios .\
RESULTS	These assessments indicated that , given the linear pharmacokinetics of moxifloxacin previously demonstrated , a dose of 400mg would produce mean Cmax/MIC values in the different subgroups ranging from 10.4 to 15.4 for an MIC of 0.25 , and 20.8 to 30.8 for an MIC of 0.125 .\
RESULTS	The corresponding ranges of projected AUC/MIC ratios would be 112 to 158 for an MIC of 0.25 , and 224 to 314 for an MIC of 0.125 .\
RESULTS	The accepted target values of AUC/MIC and Cmax/MIC for quinolones are 125 and 10 , respectively .\
RESULTS	There were no serious adverse events or differences in adverse event profiles between the groups .\
CONCLUSIONS	Moxifloxacin does not exhibit age - or gender-dependent pharmacokinetics .\
CONCLUSIONS	Oral doses of 200 to 400mg yield effective antibacterial concentrations on the first day of administration .\
\
###19850529\
OBJECTIVE	To investigate the correlation between subjective ( clinical ) treatment outcome and objective uroflowmetry parameters and curve pattern in children with dysfunctional voiding .\
METHODS	Seventy-five children were randomly allocated to two urotherapy programs .\
METHODS	Group A was submitted to standard urotherapy and pelvic floor exercises while group B received conservative treatment .\
METHODS	Constipation and recurrent urinary tract infections ( UTIs ) were treated in both groups .\
METHODS	Selected children from both groups received pharmacotherapy ( anticholinergics or desmopressin ) .\
METHODS	Uroflowmetry with electromyography of the pelvic floor and ultrasound post-void residual ( PVR ) urine volumes were obtained before and at the end of the 12-month treatment period .\
METHODS	Uroflowmetry findings were stratified into two categories based on clinical treatment outcome : ` cured ' and ` unchanged ' .\
METHODS	Uroflowmetry findings were compared between categories at the beginning and the end of the investigation .\
RESULTS	Voided volume , average and peak flow rates were significantly increased while PVR urine was decreased in children with cured urinary incontinence and nocturnal enuresis compared with ` unchanged ' category .\
RESULTS	Significant decrease of PVR urine was noted in children with cured UTIs .\
RESULTS	The frequency of a bell-shaped curve was significantly higher compared to other curve patterns in children with cured urinary incontinence and UTIs .\
CONCLUSIONS	Post-treatment improvement in clinical symptoms correlated with improvement in uroflowmetry parameters and curve pattern .\
CONCLUSIONS	Correction of voiding phase is necessary for urinary continence achievement and resolution of UTIs .\
\
###1984711\
OBJECTIVE	The authors sought to determine if an acute dose of dextroamphetamine might have positive effects on affect and cognition in schizophrenic patients maintained on a regimen of haloperidol and , if so , what variables might predict such improvements .\
METHODS	Twenty-one patients with chronic schizophrenia who were hospitalized on a research ward received a single oral dose of dextroamphetamine ( 0.25 mg/kg ) in a double-blind , placebo-controlled , crossover study .\
METHODS	All patients were receiving 0.4 mg/kg per day of haloperidol .\
METHODS	Cognitive tests , motor tests , global ratings , mood ratings , and videotape ratings were used to determine the effect of the coadministration of these drugs .\
METHODS	Ventricle-brain ratios derived from CT scans were used to predict response to the coadministration of these drugs .\
RESULTS	Amphetamine improved performance on a measure of concept formation on the Wisconsin Card Sorting Test but did not result in changes in performance on tests of memory or attention .\
RESULTS	As a group , the patients were more active and performed psychomotor tests more quickly while receiving amphetamine .\
RESULTS	Six patients were judged by clinical raters to have improved in terms of affect , cooperation , and engagement with the environment .\
RESULTS	Improvement was associated with enlarged cerebral ventricles and increases in blink rate from the placebo to the active drug condition .\
RESULTS	No patient unequivocally worsened .\
CONCLUSIONS	These results may be consistent with the theory that coadministration of amphetamine and haloperidol produces relatively selective enhancement of cortical dopaminergic activity .\
CONCLUSIONS	However , because of the acute nature of the trial and the specialized research environment in which it was conducted , the authors do not advocate amphetamine as a routine clinical treatment of schizophrenia .\
\
###11140555\
OBJECTIVE	The purpose of this study was to evaluate the clinical effectiveness of a bovine porous bone mineral used in combination with a porcine derived collagen membrane as a barrier in promoting periodontal regeneration in intrabony defects in humans .\
METHODS	The study employed a split-mouth design .\
METHODS	22 paired intrabony defects were treated and surgically re-entered 6 months after treatment .\
METHODS	Experimental sites were grafted with bovine porous bone mineral and received a collagen membrane for guided tissue regeneration .\
METHODS	Control sites were treated with an open flap debridement .\
RESULTS	Preoperative pocket depths , attachment levels and trans-operative bone measurements were similar for control and experimental sites .\
RESULTS	Post surgical measurements revealed a significantly greater reduction in pocket depth ( differences of 1.89 + / - 0.31 mm on buccal 0.88 + / - 0.27 mm on lingual measurements ) and more gain in clinical attachment ( differences of 1.51 + / - 0.33 mm on buccal and 1.50 + / - 0.35 mm on lingual measurements ) in experimental sites .\
RESULTS	Surgical reentry of the treated defects revealed a significantly greater amount of defect fill in favor of experimental sites ( differences of 2.67 + / - 0.91 mm on buccal and 2.54 + / - 0.87 mm on lingual measurements ) .\
CONCLUSIONS	The results of this study indicate that clinical resolution of intrabony defects can be achieved using a combination of bovine porous bone mineral and an absorbable , porcine derived collagen membrane when employing a technique based on the principles of guided tissue regeneration .\
CONCLUSIONS	The nature of the attachment between the newly regenerated tissue and the root surfaces needs to be evaluated histologically to confirm the presence of new attachment .\
\
###20028447\
BACKGROUND	Standard treatment for onychomycosis often results in less than half of subjects achieving disease-free nails .\
BACKGROUND	Onychomycosis is even more challenging to treat as relapses and re-infections are common .\
OBJECTIVE	To determine if a prophylactic effect exists when a treatment with amorolfine nail lacquer ( ANL ) , with half the frequency of the standard regimen , is instituted following successful treatment of dermatophytic toenail onychomycosis with matrix involvement .\
METHODS	Efficacy and safety of a group treated with ANL ( once every 2 weeks ) were compared with that of an untreated group in a 36-month ( 3 years ) , single-centre , randomized , open-label , comparison study .\
METHODS	Subjects to be included in the study were required to be cured of confirmed onychomycosis with matrix involvement after an initial treatment with either ANL + oral terbinafine or oral terbinafine alone in a previous study .\
METHODS	Prophylaxis of onychomycosis was assessed by global recurrence rate , confirmed onychomycosis , clinical recurrence and mycological recurrence .\
RESULTS	A total of 52 subjects were enrolled ( 26 in each group ) in the study .\
RESULTS	Throughout the study , recurrences occurred more quickly in the untreated group compared with that in the ANL group .\
RESULTS	Statistically significant differences were observed at month 12 ( ANL , 8.3 % ; untreated , 31.8 % ; P = 0.047 ) .\
RESULTS	At endpoint , 70.8 % of the subjects treated with ANL remained cured compared to 50 % in the untreated group ( P = 0.153 ) .\
RESULTS	Recurrence was delayed by nearly 200 days for the ANL group compared with that of the untreated group .\
RESULTS	Amorolfine was safe and well tolerated during the study , with no treatment-related adverse events .\
CONCLUSIONS	These results suggest that amorolfine nail lacquer may be effective and is safe for use as a prophylactic treatment for the recurrence of onychomycosis .\
\
###15880333\
BACKGROUND	The effect on quality of life ( QOL ) of valsartan administered in addition to prescribed background heart failure therapy was assessed as a secondary endpoint in the Valsartan Heart Failure Trial ( Val-HeFT ) .\
RESULTS	QOL was assessed in 3010 patients receiving either valsartan ( 160 mg twice daily ) or placebo in addition to prescribed background therapy ( beta-blockers or angiotensin-converting enzyme inhibitors ) , using the Minnesota Living with Heart Failure ( MLWHF ) questionnaire .\
RESULTS	Treatment differences were compared at intervals to 36 months after randomization and at endpoint ( last observation ) using analysis of covariance and repeated measures mixed-effects , and at endpoint using a Mantel-Haenszel chi-squared test .\
RESULTS	Scores lower than baseline were indicative of improved QOL .\
RESULTS	Valsartan had a significant beneficial effect on the least-square mean change in overall MLWHF score from baseline to study endpoint ( + / - standard error ) ( average followup 23.0 months ) compared with placebo ( 0.19 + / - 0.47 versus 1.94 + / - 0.48 ; P = .005 respectively ) .\
RESULTS	The placebo group was characterized by a deterioration in QOL as the trial progressed .\
RESULTS	More patients on valsartan reported a clinically meaningful improvement in MLWHF score ( a decrease of > or = 5 points ) than on placebo ( 34.0 % versus 30.2 % ) .\
CONCLUSIONS	Valsartan compared to placebo added to prescribed therapy slows progressive worsening of QOL in patients with heart failure .\
\
###12878616\
BACKGROUND	Sevoflurane and nitrous oxide have intrinsic cerebral vasodilatory activity .\
BACKGROUND	To determine the effects of nitrous oxide on cerebrovascular reactivity to carbon dioxide ( CCO ( 2 ) R ) during sevoflurane anaesthesia in children , middle cerebral artery blood flow velocity ( V ( mca ) ) was measured over a range of end-tidal carbon dioxide concentrations ( E ' ( CO ( 2 ) ) ) , using transcranial Doppler ( TCD ) ultrasonography .\
METHODS	Ten children aged 1.5-6 yr were anaesthetized with sevoflurane and received a caudal block .\
METHODS	Patients were allocated randomly to receive either air-nitrous oxide or nitrous oxide-air .\
METHODS	Further randomization determined the sequence of E ' ( CO ( 2 ) ) ( 25 , 35 , 45 , and 55 mm Hg ) and sevoflurane ( 1.0 then 1.5 MAC or 1.5 then 1.0 MAC ) concentrations .\
METHODS	Once steady state had been reached , three measurements of V ( mca ) , mean arterial pressure ( MAP ) , and heart rate ( HR ) were recorded .\
RESULTS	Cerebrovascular carbon dioxide reactivity was reduced in the 25-35 mm Hg E ' ( CO ( 2 ) ) range on the addition of nitrous oxide to 1.5 MAC , but not 1.0 MAC sevoflurane .\
RESULTS	A plateau in CCO ( 2 ) R of 0.4-0 .6 % per mm Hg was seen in all groups between E ' ( CO ( 2 ) ) values of 45 and 55 mm Hg .\
RESULTS	Mean HR and MAP remained constant throughout the study period .\
CONCLUSIONS	Cerebrovascular carbon dioxide reactivity is reduced at and above an E ' ( CO ( 2 ) ) of 45 mm Hg during 1.0 and 1.5 MAC sevoflurane anaesthesia .\
CONCLUSIONS	The addition of nitrous oxide to 1.5 MAC sevoflurane diminishes CCO ( 2 ) R in the hypocapnic range .\
CONCLUSIONS	This should be taken into consideration when hyperventilation techniques for reduction of brain bulk are being contemplated in children with raised intracranial pressure .\
\
###7992907\
BACKGROUND	When given as an intravenous bolus for induction of anesthesia , propofol can decrease postintubation hypertension but can also create moderate to severe postinduction , preintubation hypotension .\
BACKGROUND	The addition of fentanyl usually decreases the postintubation hypertension but can increase the propofol-induced preintubation hypotension .\
BACKGROUND	The goal of the study was to determine the relation between propofol and fentanyl doses and the hemodynamic changes post-induction , preintubation and postintubation .\
METHODS	Twelve groups of 10 patients , ASA physical status 1 or 2 , first received fentanyl 0 , 2 , or 4 micrograms.kg-1 and then 5 min later received propofol 2.0 , 2.5 , 3.0 , or 3.5 mg.kg-1 as an intravenous bolus for induction of anesthesia .\
METHODS	Arterial blood pressure was continuously monitored .\
METHODS	The trachea was intubated 4 min after propofol administration .\
RESULTS	The mean decrease in systolic blood pressure after propofol was 28 mmHg when no fentanyl was given , 53 mmHg after 2 microgram.kg-1 of fentanyl ( P < 0.05 vs. no fentanyl ) , and 50 mmHg after 4 micrograms.kg-1 ( P < 0.05 vs. no fentanyl ; no statistically significant difference 4 vs. 2 micrograms.kg-1 ) .\
RESULTS	There was no statistically significant difference in hemodynamic response to intubation relative to propofol dose .\
RESULTS	Hemodynamic response to intubation was decreased by the administration of fentanyl ; the mean increase of systolic blood pressure after intubation was 65 mmHg from preintubation value without fentanyl , 50 mmHg after 2 micrograms.kg-1 , and 37 mmHg after 4 micrograms.kg-1 ( P < 0.05 for 2 and 4 micrograms.kg-1 vs. no fentanyl and for 4 vs. 2 micrograms.kg-1 ) .\
RESULTS	Hemodynamic changes postintubation were not statistically different with increasing doses of propofol .\
CONCLUSIONS	Hemodynamic changes after induction with propofol or propofol/fentanyl , pre - or postintubation , are not modified when the propofol dose is increased from 2 to 3.5 mg.kg-1 .\
CONCLUSIONS	Maximal hypotension preintubation occurs with a fentanyl dose of 2 micrograms.kg-1 , whereas the magnitude of postintubation hypertension is significantly decreased with an increase in the fentanyl dose to 4 micrograms.kg-1 .\
\
###16884135\
OBJECTIVE	Our Level I Pediatric Trauma Center employs pediatric nurse practitioners ( PNP ) to manage inpatients .\
OBJECTIVE	We hypothesized that the involvement of a PNP would lead to increased nursing staff satisfaction with patient care .\
METHODS	Children admitted to the trauma service were randomized to PNP or resident care groups .\
METHODS	Nurses caring for these children were asked to fill out a satisfaction survey regarding the care that the child received .\
RESULTS	Sixty-five nurses participated .\
RESULTS	Nurses scored the PNP group significantly higher in human qualities , information given about the tests , management of the child 's pain , and response time to pages/questions .\
CONCLUSIONS	Involvement of the PNP leads to higher nursing satisfaction scores compared with residents while providing equivalent care for injured children .\
\
###11207631\
OBJECTIVE	To assess prospectively the effects of low dose oestradiol on arterial endothelial and smooth muscle function in healthy men .\
OBJECTIVE	Oestrogen use is associated with reduced cardiovascular disease in oestrogen-deficient women , however , the vascular effects of low-dose oestradiol in healthy men have not been investigated previously .\
METHODS	Twenty-three men ( aged 32 + / - 8 years ) were randomized to receive depot implants of testosterone ( T ) alone ( group 1 , n = 10 ) , or T with either 10 mg ( group 2 , n = 7 ) or 20 mg ( group 3 , n = 6 ) of oestradiol ( E ) .\
METHODS	Hormone levels , lipids and vascular reactivity were measured before , 1 month and 6 months after hormone implantation .\
METHODS	Using high-resolution ultrasound , brachial artery diameter was measured at rest , during reactive hyperaemia ( leading to flow-mediated dilatation , FMD , which is endothelium-dependent ) and after sublingual nitroglycerin ( GTN , an endothelium-independent dilator ) .\
RESULTS	Oestradiol produced a dose-dependent increase in plasma oestradiol ( at 1 month 96 + / - 7 , 149 + / - 6 , 192 + / - 23 pmol/l in the 3 groups , respectively , P < 0.001 by ANOVA for trend ) .\
RESULTS	Minor side-effects ( gynaecomastia , nipple tenderness ) indicated that 20 mg oestradiol was the maximum tolerated dose .\
RESULTS	There was also a dose-dependent increase in FMD with oestradiol dose : at 1 month , - 0.2 , + 0.2 and + 1.8 % for groups 1-3 , respectively ( P = 0.31 by ANOVA for trend ) ; and at 6 months , - 0.8 , + 0.4 and + 2.2 % ( P = 0.02 ) .\
RESULTS	The rise in oestradiol levels following treatment correlated with the improvement in FMD ( P = 0.01 ) .\
RESULTS	GTN responses were similar in the 3 groups throughout the study .\
CONCLUSIONS	In healthy young men , oestradiol supplementation is associated with enhanced arterial endothelial function , a key marker of vascular health .\
\
###9286191\
OBJECTIVE	The purpose of this study was to determine whether combined treatment with a selective serotonin reuptake inhibitor ( SSRI ) and a norepinephrine reuptake inhibitor , desipramine , effectively reduces obsessive-compulsive symptoms in patients who do not respond to SSRIs .\
METHODS	In a double-blind study , desipramine or placebo was added for 6 or 10 weeks to the treatment of 30 patients with obsessive-compulsive disorder whose symptoms were refractory to SSRI treatment ( fluvoxamine , fluoxetine , or sertraline ) alone .\
RESULTS	There were no significant differences between the adjunctive desipramine and placebo groups in obsessive-compulsive or depressive symptoms .\
CONCLUSIONS	These data suggest that clomipramine 's possibly superior efficacy in the treatment of obsessive-compulsive symptoms may not stem from its capacity to inhibit reuptake of norepinephrine .\
\
###17507833\
OBJECTIVE	To compare the changes induced by oral versus transdermal estrogen therapy on the total and free serum concentrations of testosterone ( T ) , thyroxine ( T4 ) , and cortisol ( C ) and the concentrations of their serum binding globulins sex hormone-binding globulin , thyroxine-binding globulin , and cortisol-binding globulin in naturally menopausal women .\
METHODS	Randomized , open-label , crossover .\
METHODS	Interventions included a 6-week withdrawal from previous hormone therapy ( baseline ) , followed in randomized order by 12 weeks of oral conjugated equine estrogens ( CEE ) ( 0.625 mg/d ) and 12 weeks of transdermal estradiol ( TD E2 ) ( 0.05 mg/d ) , with oral micronized progesterone ( 100 mg/d ) given continuously during both transdermal estrogen therapy regimens .\
RESULTS	Twenty-seven women were enrolled in the study , and 25 completed both treatment periods .\
RESULTS	The mean ( SD ) percentage changes from baseline of sex hormone-binding globulin , total T , and free T with oral CEE were +132.1 % ( 74.5 % ) , +16.4 % ( 43.8 % ) , and -32.7 % ( 25.9 % ) , respectively , versus +12.0 % ( 25.1 % ) , +1.2 % ( 43.7 % ) , and +1.0 % ( 45.0 % ) with TD E2 .\
RESULTS	The mean ( SD ) percentage changes of thyroxine-binding globulin , total T4 , and free T4 with oral CEE were +39.9 % ( 20.1 % ) , +28.4 % ( 29.2 % ) , and -10.4 % ( 22.3 % ) , respectively , versus +0.4 % ( 11.1 % ) , -0.7 % ( 16.5 % ) , and +0.2 % ( 26.6 % ) with TD E2 .\
RESULTS	The mean ( SD ) percentage changes of cortisol-binding globulin , total C , and free C with oral CEE were +18.0 % ( 19.5 % ) , +29.2 % ( 46.3 % ) , and +50.4 % ( 126.5 % ) , respectively , versus -2.2 % ( 11.3 % ) , -6.7 % ( 30.8 % ) , and +1.8 % ( 77.1 % ) with TD E2 .\
RESULTS	Concentrations of all hormones and binding globulins were significantly different ( P < or = 0.003 ) during administration of oral versus transdermal estrogen therapy , except for free T4 and free C.\
CONCLUSIONS	Compared with oral CEE , TD E2 exerts minimal effects on the total and free concentrations of T , T4 , and C and their binding proteins .\
\
###20581169\
BACKGROUND	Pulmonary arterial hypertension ( PAH ) is a progressive condition with a poor prognosis .\
BACKGROUND	Platelet-derived growth factor receptor ( PDGFR ) signaling plays an important role in its pathobiology .\
OBJECTIVE	To assess safety , tolerability , and efficacy of the PDGFR inhibitor imatinib in patients with PAH .\
METHODS	Patients with PAH in functional classes II-IV were enrolled in a 24-week randomized , double-blind , placebo-controlled pilot study .\
METHODS	Patients received imatinib ( an inhibitor of PDGFR activity ) 200 mg orally once daily ( or placebo ) , which was increased to 400 mg if the initial dose was well tolerated .\
METHODS	The primary endpoints were safety and change from baseline in the 6-minute-walk distance ( 6MWD ) .\
METHODS	Secondary endpoints included hemodynamics and functional classification .\
RESULTS	Fifty-nine patients enrolled ( imatinib [ n = 28 ] ; placebo [ n = 31 ] ) ; 42 completed the study .\
RESULTS	Dropouts were equally matched between the two groups .\
RESULTS	In the intention-to-treat ( ITT ) population there was no significant change in the 6MWD ( mean SD ) in the imatinib versus placebo group ( +22 63 versus -1.0 53 m ) .\
RESULTS	There was a significant decrease in pulmonary vascular resistance ( imatinib -300 347 versus placebo -78 269 dynes s cm , P < 0.01 ) and increase in cardiac output ( imatinib +0.6 1.2 versus placebo -0.1 0.9 L/min , P = 0.02 ) .\
RESULTS	Serious adverse events occurred in 11 imatinib recipients ( 39 % ) and 7 placebo recipients ( 23 % ) .\
RESULTS	Three deaths occurred in each group .\
RESULTS	Post hoc subgroup analyses suggest that patients with greater hemodynamic impairment may respond better than patients with less impairment .\
CONCLUSIONS	These data from a Phase II study are consistent with imatinib being well tolerated in patients with PAH , and provide proof of concept for further studies evaluating its safety , tolerability , and efficacy in PAH .\
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT00477269 ) .\
\
###15598479\
BACKGROUND	Many patients with head and neck cancer have difficulty swallowing tablet formulations of medications , and use of dispersion preparations may be advantageous .\
OBJECTIVE	The aim of the present study was to determine the relative bioavailability and safety profile of a single dose of gefitinib , an orally active inhibitor of epidermal growth factor receptor tyrosine kinase , when administered as a whole 250-mg tablet or as a dispersion preparation via drink or nasogastric tube in healthy male volunteers .\
METHODS	This was a Phase 1 , randomized , open-label , 3-period crossover study .\
METHODS	Plasma samples obtained before dosing to 240 hours after dosing were analyzed for gefitinib using reverse-phase high-performance liquid chromatography with tandem mass-spectrometric detection .\
METHODS	The pharmacokinetic parameters of interest included AUC , C ( max ) , and the relative bioavailability of the dispersion via drink or nasogastric tube compared with the standard tablet .\
RESULTS	Eighteen healthy white male volunteers were enrolled .\
RESULTS	They had a mean age of 43 years ( range , 21-59 years ) , mean body weight of 85.1 kg ( range , 60-101 kg ) , and mean height of 180.3 cm ( range , 171-187 cm ) .\
RESULTS	The geometric mean AUC was 2219 ng.h / mL for a single 250-mg dose of gefitinib administered as a whole tablet , 2233 ng.h / mL for the dispersion preparation administered by drink , and 2007 ng.h / mL for the dispersion preparation administered by nasogastric tube .\
RESULTS	The corresponding values for the geometric mean C ( max ) were 95.2 , 96.3 , and 89.9 ng/mL .\
RESULTS	The gefitinib dispersion preparation administered by drink had a mean bioavailability of 103.8 % relative to the whole tablet ; the dispersion preparation administered by nasogastric tube had a mean bioavailability of 99.1 % relative to the whole tablet .\
RESULTS	For the drink-tablet and nasogastric tube-tablet comparisons , the estimate-of-treatment ratios for the AUC were a respective 1.006 and 0.928 ; for the C ( max ) , they were 1.012 and 0.964 .\
RESULTS	There appeared to be no clinically significant differences in absorption or elimination between the preparations .\
RESULTS	Three volunteers experienced adverse events ( AEs ) that were considered possibly related to gefitinib ( pruritus and dry skin ) , and 6 volunteers experienced procedure-related AEs ( cannula-site reaction and rhinorrhea ) ; these AEs were mild or moderate .\
RESULTS	No serious AEs were recorded , and no AEs led to withdrawal of any volunteer .\
CONCLUSIONS	Administration of a 250-mg dose of gefitinib as a dispersion preparation by drink or nasogastric tube achieved a systemic exposure to gefitinib that was consistent with that achieved when gefitinib was administered as a whole tablet .\
CONCLUSIONS	There was no evidence of tolerability problems associated with the routes of administration studied in these healthy volunteers .\
\
###17466655\
OBJECTIVE	Patients using albuterol and ipratropium for treating chronic obstructive pulmonary disease ( COPD ) can use either nebulizers or metered dose inhalers .\
OBJECTIVE	This study compared the 2 methods of delivering medication and the concomitant use of both nebulizer and inhaler , with respect to health-related quality of life , patient symptoms , and efficacy .\
METHODS	Patients over 50 years old with COPD were randomized into 3 groups : nebulizer , inhaler , or concomitant treatment .\
METHODS	Quality of life was assessed using the St. George 's Respiratory Questionnaire at baseline , and at 6 and 12 weeks .\
METHODS	Other efficacy measurements at these time-points included pre - and post-dose forced expired volume in 1 second ( FEV1 ) .\
METHODS	Symptom scores and peak flow measurements were recorded in patient diaries .\
RESULTS	Of 140 patients enrolled , 126 completed at least one post-baseline assessment .\
RESULTS	At week 6 , both groups using a nebulizer achieved statistically significant improvements from baseline in questionnaire symptoms , and the concomitant treatment group had clinically and statistically significant improvement in total questionnaire score .\
RESULTS	At week 12 , the concomitant group still maintained significant improvement in symptom sub-scores .\
RESULTS	The 3 groups showed little change over time in peak flow or FEV1 , with no significant difference among groups .\
RESULTS	Both groups using a nebulizer had significant improvement over time in diary symptom scores , although differences between groups were not significant .\
CONCLUSIONS	Patients using combined nebulizer therapy morning and night with mid-day inhaler use had the most statistically significant improvements in quality of life indices .\
CONCLUSIONS	This concomitant regimen provides the additional symptom relief offered by a nebulizer with the convenience of an inhaler when patients are away from home .\
\
###9793223\
OBJECTIVE	To compare the results of recording enamel opacities using the TF and modified DDE indices .\
METHODS	Enamel opacities on the maxillary central incisors were recorded two weeks apart .\
METHODS	On the first occasion scoring was according to the criteria of the TF index and on the second occasion the modified DDE index was used .\
METHODS	An intraoral colour slide photograph was taken of the teeth of each subject and these were scored on two occasions in random order , first using the TF index and secondly using the modified DDE index .\
METHODS	Three hundred and twenty-five 9-year-old children who were life time residents in an area where the domestic water was fluoridated at one part per million .\
RESULTS	Agreement between clinical and photograph scoring was good for both TF and modified DDE indices , Spearman 's Rank Correlation Coefficients being 0.77 and 0.69 respectively .\
RESULTS	There was also good agreement between the distribution of scores for the two indices as indicated by Coefficients of 0.75 for clinical scores and 0.76 for photographic scores .\
CONCLUSIONS	There was good agreement between the TF and modified DDE indices when recording the distribution of milder types of enamel opacities in a population of 9-year-old children .\
\
###9570261\
BACKGROUND	There is need for an evidence-based comparison of clinical management strategies to provide the rationale for selection of a particular therapeutic approach to treatment .\
BACKGROUND	Ideal dyspepsia treatment should quickly and conveniently alleviate patient symptoms whilst also minimizing the use of healthcare resources .\
OBJECTIVE	To examine dyspepsia symptom relief over 16 weeks and compare an omeprazole clinical management strategy with a commonly used combination of antacid-alginate followed by H2-antagonist .\
METHODS	Seven hundred and twenty-five patients participated in this randomized , open , parallel group comparison over 16 weeks .\
METHODS	Patients were randomized to receive either an omeprazole treatment strategy ( 363 ) consisting of omeprazole 10 mg stepping up to 20 mg and 40 mg as required , or an antacid-alginate/ranitidine treatment strategy ( 362 ) consisting of antacid-alginate 10 mL q.d.s. stepping up to ranitidine 150 mg b.d. and 150 mg q.d.s. as required .\
RESULTS	A greater proportion of patients receiving the omeprazole clinical management strategy had achieved the stringent health target of complete symptom relief ( 61 vs. 40 % , P < 0.0001 ) at 16 weeks .\
RESULTS	Forty-six per cent of omeprazole-treated patients were symptom free after the first 10 mg step compared to only 17 % in the antacid-alginate treated group ( P = 0.0001 ) .\
RESULTS	Total relief of heartburn , the most common symptom at entry , was achieved by more patients in the omeprazole treatment group than the antacid-alginate/ranitidine treatment group , 62 vs. 36 % , respectively , at 4 weeks , and 81 vs. 60 % at 16 weeks ( P = 0.0001 ) .\
CONCLUSIONS	Treatment with the omeprazole clinical management strategy was superior to the antacid-alginate/ranitidine management strategy in providing relief of acid-related dyspepsia symptoms after 16 weeks .\
CONCLUSIONS	In addition , the omeprazole treatment strategy involved fewer GP consultations and thus minimized the use of other healthcare resources .\
\
###21115454\
OBJECTIVE	Methicillin-resistant Staphylococcus aureus ( MRSA ) has emerged as a common cause of complicated skin and skin structure infections ( cSSSIs ) .\
OBJECTIVE	Increasing antibiotic resistance and significant morbidity in cSSSIs have led to a need for new effective and safe therapies .\
OBJECTIVE	Ceftaroline fosamil , a novel parenteral cephalosporin with excellent in vitro activity against Gram-positive pathogens , including MRSA , and many Gram-negative pathogens , was evaluated as therapy for cSSSIs in a large multicentre study .\
OBJECTIVE	The primary study objective was to determine non-inferiority [ lower limit of 95 % confidence interval ( CI ) , -10 % ] in the clinical cure rate achieved with ceftaroline fosamil monotherapy compared with that achieved with vancomycin plus aztreonam in the clinically evaluable ( CE ) and modified intent-to-treat ( MITT ) patient populations .\
METHODS	Adult patients with cSSSIs requiring intravenous therapy received 600 mg of ceftaroline fosamil every 12 h or 1 g of vancomycin plus 1 g of aztreonam every 12 h for 5-14 days ( randomized 1:1 ) .\
METHODS	Clinical and microbiological response , adverse events ( AEs ) and laboratory tests were assessed .\
METHODS	Registration number NCT00424190 ( http://clinicaltrials.gov/ct2/show/NCT00424190 ) .\
RESULTS	Of 702 enrolled patients , 353 received ceftaroline fosamil and 349 received vancomycin plus aztreonam .\
RESULTS	Baseline characteristics of treatment groups were comparable .\
RESULTS	Clinical cure rates were similar for ceftaroline fosamil and vancomycin plus aztreonam in the CE ( 91.1 % , 288/316 versus 93.3 % , 280/300 ; 95 % CI , -6.6 , 2.1 ) and MITT ( 86.6 % , 304/351 versus 85.6 % , 297/347 ; 95 % CI , -4.2 , 6.2 ) populations , respectively .\
RESULTS	The clinical cure rate for MRSA cSSSIs was 95.1 % ( 78/82 ) for ceftaroline fosamil and 95.2 % ( 59/62 ) for vancomycin plus aztreonam .\
RESULTS	The microbiological success rate was also similar for ceftaroline fosamil and vancomycin overall , and for MRSA .\
RESULTS	The rates of AEs , serious AEs , deaths and discontinuations because of an AE were similar for ceftaroline fosamil and vancomycin plus aztreonam .\
RESULTS	The most common AEs for ceftaroline fosamil and vancomycin plus aztreonam were diarrhoea ( 3.4 % versus 3.2 % ) , nausea ( 5.7 % versus 4.6 % ) , headache ( 5.1 % versus 3.7 % ) and pruritus ( 3.1 % versus 8.4 % ) , respectively .\
CONCLUSIONS	Ceftaroline fosamil achieved high clinical cure and microbiological success rates , was efficacious for cSSSIs caused by MRSA and other common cSSSI pathogens and was generally well tolerated .\
CONCLUSIONS	Ceftaroline fosamil has the potential to provide a monotherapy alternative for treatment of cSSSIs .\
\
###12093661\
OBJECTIVE	To assess the efficacy of a new application technique of mitomycin-C to enhance the outcome of filtering surgery in cases of complicated glaucoma .\
METHODS	Randomized clinical trial .\
METHODS	Fifty consecutive patients scheduled for glaucoma surgery in one large surgical center .\
METHODS	Patients underwent routine trabeculectomy .\
METHODS	In group 1 , mitomycin-C ( 0.05 mg/ml ) was applied topically to the filtering bleb on days 1 , 2 , and 3 after surgery ( postoperative application ) .\
METHODS	In group 2 , mitomycin-C ( 0.2 mg/ml ) was applied by means of to a sponge during surgery ( intraoperative application ) .\
METHODS	Preoperative and postoperative intraocular pressure ( IOP ) values , visual acuity , the need for antiglaucoma medication , previous surgical procedures , and the need for further surgical interventions were monitored .\
RESULTS	Sufficient follow-up data were available from 24 of 25 patients in each of the two groups .\
RESULTS	The follow-up ranged from 12 to 28 months and was evaluated at 12 months for all patients .\
RESULTS	The mean IOP decreased from 27.3 to 15.5 mmHg in group 1 and from 29.0 to 17.5 mmHg in group 2 .\
RESULTS	The average number of medications decreased from 2.3 and 2.4 to 0.9 and 0.8 ( P = 0.68 ; t test ) in groups 1 and 2 , respectively , at the 12-month visit .\
RESULTS	Hypotony was more frequent in group 2 , in which the only case of hypotony maculopathy occurred .\
RESULTS	There was a tendency of more eyes with lower IOP values in this group .\
RESULTS	The rate of loss of visual acuity of more than 2 lines was higher in group 2 .\
RESULTS	Failures were more frequent in group 2 ( 7 of 24 ) compared with group 1 ( 1 of 24 ) ( P = 0.04 , chi-square test ) .\
CONCLUSIONS	To our knowledge , this is the first prospective , randomized clinical study to evaluate the efficacy of this different technique of mitomycin-C application .\
CONCLUSIONS	The postoperative application of mitomycin-C was effective , having few failures .\
CONCLUSIONS	This application of mitomycin-C may be associated with a lower rate of complications when used in eyes with complicated forms of glaucoma .\
\
###9773719\
OBJECTIVE	To determine the relationship between carbohydrate intake and the effect of acarbose on HbA1c in subjects with type 2 diabetes treated with acarbose alone , acarbose plus sulfonylurea , acarbose plus metformin , or acarbose plus insulin .\
METHODS	We conducted a double-blind randomized placebo-controlled study in which subjects with diabetes in four treatment strata ( 77 on diet alone , 83 treated with metformin , 103 treated with sulfonylurea , and 91 treated with insulin ) were randomized to treatment with placebo or acarbose for 12 months .\
METHODS	Before randomization , and 3 , 6 , 9 , and 12 months after randomization , fasting blood was obtained for HbA1c , and 3-day diet records were collected .\
METHODS	Subjects who completed at least 6 months of acarbose therapy and provided at least three 3-day diet records were included .\
RESULTS	In the 114 subjects included in this analysis , carbohydrate intake varied from approximately 30-60 % of energy There was no significant relationship between carbohydrate intake and change in HbA1c in any of the four treatment strata ( diet : n = 26 , r = 0.35 , P = 0.076 ; metformin : n = 27 , r = 0.26 , P = 0.19 ; sulfonylurea : n = 35 , r = 0.24 , P = 0.16 ; insulin : n = 25 , r = -0.27 , P = 0.19 ) .\
RESULTS	In the 80 subjects consuming < 50 % of energy from carbohydrate , the fall in HbA1c ( 7.83 + / -0.17 % at baseline to 6.72 + / -0.13 % on acarbose , P < 0.001 ) was no different from that of the 34 subjects consuming > 50 % of energy from carbohydrate ( 7.55 + / -0.25 % at baseline to 6.66 + / -0.23 % on acarbose , P < 0.001 ) .\
RESULTS	There was no difference in carbohydrate intake between those who dropped out of the study because of gastrointestinal side effects and those who did not , and there was no relationship between severity of symptoms and the composition of the diet .\
CONCLUSIONS	In subjects with type 2 diabetes consuming 30-60 % of energy from carbohydrate , the effect of acarbose on HbA1c and gastrointestinal symptoms was not related to carbohydrate intake .\
CONCLUSIONS	Because most people consume at least 30 % of energy from carbohydrate , we conclude that no special diet is needed for acarbose to be effective in improving blood glucose control in the treatment of type 2 diabetes .\
\
###23987833\
OBJECTIVE	We aimed to evaluate the effect of prior chemotherapies on the outcomes of patients with liposarcoma and leiomyosarcoma treated with trabectedin as a 24-h infusion every 3 weeks .\
METHODS	Data from 129 patients who received trabectedin as second-line treatment following failure with an anthracycline/ifosfamide and those who had received at least two lines of prior chemotherapy were analyzed .\
RESULTS	Forty seven patients received one prior regimen ( group A ) and 82 patients received at least two lines of chemotherapy ( group B ) .\
RESULTS	A favorable trend in median time to progression ( 4.4 vs 3.0 months ) , progression-free survival ( 4.4 vs 2.6 months ) and overall survival ( 17.4 vs 13.3 months ) was found in group A.\
RESULTS	A trend toward higher overall response rate ( 6.4 vs 4.9 % ) and disease control rate ( 34.0 vs 26.8 % ) also favored group A. Both groups had equivalent safety profiles .\
CONCLUSIONS	All efficacy outcomes were better in patients who received trabectedin as second-line treatment compared with patients with more extensive prior therapy .\
\
###16137275\
OBJECTIVE	To evaluate whether an early multidisciplinary geriatric intervention in elderly patients with hip fracture reduced length of stay , morbidity , and mortality and improved functional evolution .\
METHODS	Randomized , controlled intervention trial .\
METHODS	Orthopedic ward in a university hospital .\
METHODS	Three hundred nineteen patients aged 65 and older hospitalized for hip fracture surgery .\
METHODS	Participants were randomly assigned to a daily multidisciplinary geriatric intervention ( n = 155 ) or usual care ( n = 164 ) during hospitalization in the acute phase of hip fracture .\
METHODS	Primary endpoints were in-hospital length of stay and incidence of death or major medical complications .\
METHODS	Secondary endpoints were the rate of recovery of previous activities of daily living and ambulation ability at 3 , 6 , and 12 months .\
RESULTS	Median length of stay was 16 days in the geriatric intervention group and 18 days in the usual care group ( P = .06 ) .\
RESULTS	Patients assigned to the geriatric intervention showed a lower in-hospital mortality ( 0.6 % vs 5.8 % , P = .03 ) and major medical complications rate ( 45.2 % vs 61.7 % , P = .003 ) .\
RESULTS	After adjustment for confounding variables , geriatric intervention was associated with a 45 % lower probability of death or major complications ( 95 % confidence interval = 7-68 % ) .\
RESULTS	More patients in the geriatric intervention group achieved a partial recovery at 3 months ( 57 % vs 44 % , P = .03 ) , but there were no differences between the groups at 6 and 12 months .\
CONCLUSIONS	Early multidisciplinary daily geriatric care reduces in-hospital mortality and medical complications in elderly patients with hip fracture , but there is not a significant effect on length of hospital stay or long-term functional recovery .\
\
###20961772\
OBJECTIVE	To compare the efficacy , safety , and outcome of thoracoscopic talc poudrage ( TTP ) versus povidone-iodine pleurodesis ( PIP ) through a thoracostomy tube as a palliative treatment of pleural effusion due to metastatic breast carcinoma ( MBC ) .\
METHODS	A total of 42 MBC patients were prospectively enrolled in a randomized controlled trial .\
METHODS	Twenty-two patients received TTP ( group A ) , whereas 20 patients ( group B ) underwent pleurodesis by instilling povidone-iodine through a thoracostomy tube , as a bedside procedure .\
RESULTS	The mean age was 48.2 9.9 ( range : 29-64 ) years and 50.2 7 ( range : 32-62 ) years for groups A and B , respectively ( p = ns ) .\
RESULTS	At presentation , all patients had moderate to severe dyspnea , New York Heart Association ( NYHA ) > II and Medical Research Council ( MRC ) dyspnea scale 3-5 .\
RESULTS	Morbidity in both groups was low .\
RESULTS	Post-procedure analgesic requirements due to severe pleuritic chest pain were higher in group A ( 18 % vs 0 % , p = 0.2 ) .\
RESULTS	Four patients in group A ( 18 % ) and one in group B ( 5 % ) were febrile ( > 38C ) within 48 h of the procedure .\
RESULTS	Both groups achieved good symptom control , with improvement in MRC dyspnea scale ( 1-3 ) .\
RESULTS	There were no in-hospital deaths .\
RESULTS	Post-procedure hospital stay was lower in group B ( p = 0.009 ) .\
RESULTS	The mean progression-free interval was 6.6 ( range 3-15 ) months .\
RESULTS	At follow-up ( mean : 22.6 ( range : 8-48 ) months ) , recurrence of significant pleural effusion requiring intervention was noted in two and three patients in group A and group B , respectively ( p = ns ) .\
CONCLUSIONS	Povidone-iodine can be considered as a good alternative to TTP to ensure effective pleurodesis for patients with malignant pleural effusion due to MBC .\
CONCLUSIONS	The drug is available , cost effective and safe , can be given through a thoracostomy tube and can be repeated if necessary .\
\
###12211882\
OBJECTIVE	This study investigates the drug consumption patterns of a sample of rave attendees in the city of Montreal , Quebec , and seeks to identify the prevalence of 3,4-methylendioxymethamphetamine ( MDMA ) and other drug use in this population .\
METHODS	We administered a self-report questionnaire to 210 respondents .\
METHODS	For various licit and illicit substances , participants reported their age of first use , number of lifetime uses , and usage in the previous 30 days .\
RESULTS	We found a significant rank order for the sequence of first use : 1 ) alcohol , 2 ) nicotine , 3 ) cannabis , 4 ) LSD , 5 ) psilocybin , 6 ) amphetamine , 7 ) cocaine , 8 ) MDMA , 9 ) gamma-hydroxybutyrate ( GHB ) , 10 ) ephedrine , 11 ) ketamine .\
RESULTS	Alcohol and cannabis were the most commonly used substances , both in cumulative number of lifetime uses and in usage in the preceding 30 days .\
RESULTS	MDMA and amphetamine were also notable as the next 2 most popular drugs for use in the preceding 30 days and in terms of those who had tried the drugs at least once .\
RESULTS	We identified a progressive rank order of experimentation , with early alcohol or cannabis use ( or both ) associated with the early use of all other drugs tried by more than 25 % of the sample .\
RESULTS	We found MDMA and amphetamine use to be prevalent , as was general experimentation with all drugs studied , other than heroin .\
CONCLUSIONS	Drug consumption levels were substantial in this `` rave '' population , particularly with respect to recent use of MDMA , amphetamine , cannabis , and alcohol .\
CONCLUSIONS	Results also indicate that the sequence of drug experimentation in this population follows an identifiable pattern .\
\
###19058059\
OBJECTIVE	To investigate the influence of smoking on bone during therapy with nasally administrated estradiol in sequential combination with oral progesterone in early postmenopausal women .\
OBJECTIVE	In addition , to observe the consequences of smoking on bone in untreated women .\
METHODS	Post-hoc exploratory analyses of data from 270 postmenopausal women randomized to 2 years ' therapy with daily nasal administration of 17beta-estradiol or placebo sequentially combined with oral micronized progesterone in the active groups or placebo in the placebo group .\
RESULTS	During treatment with nasal estradiol , the bone mineral density ( BMD ) of the lumbar spine had increased less at 2 years in smokers as compared to non-smokers ( 2.6 % vs. 3.9 % , p = 0.03 ) .\
RESULTS	Parallel changes were seen in the placebo group ( -3.6 % vs. -2.4 % , p = 0.08 ) .\
RESULTS	In the total hip BMD , there was no difference in the response to estradiol in smokers vs. non-smokers ( 1.4 % vs. 1.4 % , p = 0.89 ) , whereas the change in the hip on the placebo was similar to that seen in the spine ( -3.7 % vs. -2.6 % , p = 0.08 ) .\
RESULTS	Supportive changes were seen in urinary CTX and in serum osteocalcin .\
CONCLUSIONS	These results indicate that cigarette smoking may reduce the efficacy of nasal estradiol to increase bone mass in early postmenopausal women .\
CONCLUSIONS	In addition , smoking may increase spontaneous bone loss in untreated women .\
\
###19243716\
BACKGROUND	Varenicline is approved as an aid to smoking cessation in adults aged > or = 18 years .\
OBJECTIVE	The goal of this study was to characterize the multiple-dose pharmacokinetics , safety , and tolerability of varenicline in adolescent smokers .\
METHODS	This multicenter , randomized , double-blind , placebo-controlled , parallel-group study enrolled healthy 12 - to 16-year-old smokers ( > or = 3 cigarettes daily ) into high-body-weight ( > 55 kg ) and low-body-weight ( < or = 55 kg ) groups .\
METHODS	Subjects were randomized to receive 14 days of treatment with a high dose of varenicline , a low dose of varenicline , or placebo .\
METHODS	The varenicline doses in the high-body-weight group were 1 mg BID and 0.5 mg BID ; the varenicline doses in the low-body-weight group were 0.5 mg BID and 0.5 mg once daily .\
METHODS	The apparent renal clearance ( CL/F ) and volume of distribution ( V/F ) of varenicline and the effect of body weight on these parameters were estimated using nonlinear mixed-effects modeling .\
RESULTS	The high-body-weight group consisted of 35 subjects ( 65.7 % male ; 77.1 % white ; mean age , 15.2 years ) .\
RESULTS	The low-body-weight group consisted of 37 subjects ( 37.8 % male ; 48.6 % white ; mean age , 14.3 years ) .\
RESULTS	The pharmacokinetic parameters of varenicline were dose proportional over the dose range from 0.5 to 2 mg/d .\
RESULTS	The CL/F for a 70-kg adolescent was 10.4 L/h , comparable to that in a 70-kg adult .\
RESULTS	The estimated varenicline V/F was decreased in individuals of small body size , thus predicting a varenicline C ( max ) approximately 30 % greater in low-body-weight subjects than in high-body-weight subjects .\
RESULTS	In high-body-weight subjects , steady-state varenicline exposure , as represented by the AUC ( 0-24 ) , was 197.0 ng .\
RESULTS	h/mL for varenicline 1 mg BID and 95.7 ng .\
RESULTS	h/mL for varenicline 0.5 mg BID , consistent with values reported previously in adult smokers at the equivalent doses .\
RESULTS	In low-body-weight subjects , varenicline exposure was 126.3 ng .\
RESULTS	h/mL for varenicline 0.5 mg BID and 60.1 ng .\
RESULTS	h/mL for varenicline 0.5 mg once daily , values at the lower end of the range observed previously in adults at doses of 1 mg BID and 0.5 mg BID , respectively .\
RESULTS	Among high-body-weight subjects , adverse events ( AEs ) were reported by 57.1 % of subjects in both the high - and low-dose varenicline groups and by 14.3 % of subjects in the placebo group ; among low-body-weight subjects , AEs were reported by 64.3 % , 73.3 % , and 12.5 % of subjects in the high-dose varenicline , low-dose varenicline , and placebo groups , respectively .\
RESULTS	The most common AEs were nausea , headache , vomiting , and dizziness .\
RESULTS	Psychiatric AEs that were considered treatment related included abnormal dreams in 2 subjects and mild , transient anger in 1 subject .\
RESULTS	Of the AEs reported by > or = 1 subject in any treatment group , > or = 92 % were mild in intensity .\
RESULTS	No subject discontinued the study because of an AE .\
CONCLUSIONS	Varenicline steady-state exposure in study subjects weighing > 55 kg was similar to that observed previously in adults .\
CONCLUSIONS	The body-weight effect on varenicline pharmacokinetics , which resulted in higher exposure in individuals of smaller body size ( < or = 55 kg ) , was adequately offset by administration of half the varenicline dose recommended in adults .\
CONCLUSIONS	Varenicline was generally well tolerated during the 14-day treatment period .\
CONCLUSIONS	Clinical Trials Identification Number : NCT00463918 .\
\
###23686394\
BACKGROUND	Spatial orientation in natural orifice translumenal endoscopic surgery ( NOTES ) has been identified as a potential barrier to clinical application .\
BACKGROUND	We aim to evaluate a triaxial inertial sensor and software that automatically corrects any movements on the roll axis of the flexible endoscope , allowing for stabilization of the image horizon during NOTES operations in a randomized controlled trial .\
METHODS	A total of 18 participants ( 11 surgeons/7 gastroenterologists ) performed a transgastric task in the ELITE simulator , which included navigation to the appendix and gallbladder , diathermy of the appendix base and gallbladder fossa , and clipping of the cystic duct using a single-channel gastroscope .\
METHODS	Each participant performed the task twice with randomization to horizon stabilization occurring at the second attempt .\
METHODS	The primary end point was change in overall performance ( time taken and errors made ) between the first and second attempt , and secondary end points were absolute performances in the second attempt and subjective evaluation .\
RESULTS	Without horizon stabilization , there was a median improvement of 42.4 % in time taken and 38 % in number of errors made from the first to the second attempt ; however , with the software turned on , there was a statistically significant deterioration of 4.9 % ( P = .038 ) in time taken and an increase in errors made of 183 % ( P = ns ) .\
CONCLUSIONS	Although the software corrects the view to that preferred during surgery , the endoscopic control mechanism as well as the exit point of the instrument are altered in this process , leading to a deterioration of overall performance .\
CONCLUSIONS	Potential solutions include deploying intermittent horizon stabilization or using a robotic interface to achieve fully aligned perceptual-motor control .\
\
###21777999\
BACKGROUND	Below-knee amputees commonly experience asymmetrical gait patterns and develop comorbidities in their intact and residual legs .\
BACKGROUND	Carbon fiber prosthetic feet have been developed to minimize these asymmetries by utilizing elastic energy storage and return to provide body support , forward propulsion and leg swing initiation .\
BACKGROUND	However , how prosthetic foot stiffness influences walking characteristics is not well-understood .\
BACKGROUND	The purpose of this study was to identify the influence of foot stiffness on kinematics , kinetics , muscle activity , prosthetic energy storage and return , and mechanical efficiency during amputee walking .\
METHODS	A comprehensive biomechanical analysis was performed on 12 unilateral below-knee amputees .\
METHODS	Subjects walked overground at 1.2 m/s with three prosthetic feet of varying keel and heel stiffness levels , which were created using additive manufacturing .\
RESULTS	As stiffness decreased , peak residual and intact leg ankle angles and residual leg knee flexion angle increased .\
RESULTS	The residual and intact leg braking ground reaction forces and knee extensor moments , residual leg vastus and gluteus medius activity , and intact leg vastus and rectus femoris activity also increased .\
RESULTS	The second vertical ground reaction force peak and hamstring activity in the residual leg and first vertical ground reaction force peak in the intact leg decreased .\
RESULTS	In addition , prosthetic energy storage and return increased and mechanical efficiency decreased as stiffness decreased .\
CONCLUSIONS	Decreasing foot stiffness can increase prosthesis range of motion , mid-stance energy storage and late-stance energy return , but the net contributions to forward propulsion and swing initiation may be limited as additional muscle activity to provide body support becomes necessary .\
\
###18854793\
BACKGROUND	The inability to provide effective postoperative analgesia is one of the major disadvantages of intravenous regional anesthesia ( IVRA ) .\
BACKGROUND	We designed a prospective , randomized , double blind study to evaluate the analgesic effectiveness of adding both ketorolac and dexamethasone to lidocaine for IVRA .\
METHODS	The study involved 45 patients undergoing ambulatory hand surgery .\
METHODS	They were randomly allocated into three groups : Group L , Group LK and Group LDK .\
METHODS	Group L received 3 mg x kg-1 lidocaine ; Group LK received 3 mg x kg-1 lidocaine + 30 mg ketorolac ; and Group LDK received 3 mg x kg-1 lidocaine for IVRA + 8 mg dexamethasone + 30 mg ketorolac for IVRA using a 40 mL solution .\
METHODS	Sensory and motor block onset and recovery times were recorded .\
METHODS	Tourniquet pain and pain at the operative site were assessed by a visual analog scale .\
METHODS	In the first 24 h after surgery , opioid requirements and total analgesic consumption , including side effects , were noted .\
RESULTS	Sensory and motor block onset and recovery times were similar in all groups .\
RESULTS	Patients in Groups LK and LDK required less alfentanyl for control of intraoperative and early postoperative pain .\
RESULTS	Further , patients in Groups LK and LDK reported significantly lower pain scores compared to those in Group L ( P < 0.001 ) .\
RESULTS	Patients in Groups LK and LDK required fewer postoperative ketorolac tablets ( 2.2 + / -1.6 and 1.3 + / -0.6 tablets , respectively ) in the first 24 h after surgery and had significantly longer periods during which they required no analgesics ( 524 min and 566 min , respectively ) compared to those in Group L ( 3.8 + / -1.3 tablets ; 122 min , P < 0.001 ) .\
CONCLUSIONS	IVRA with lidocaine and with the inclusion of ketorolac and dexamethasone provides effective perioperative analgesia for patients undergoing ambulatory hand surgery , when compared to the use of lidocaine alone or lidocaine with ketorolac IVRA .\
\
###25440560\
OBJECTIVE	To investigate whether Sudarshan Kriya and related practices ( SK&P ) can lead to increased global assessment of functioning ( GAF ) and increased feeling of wellness in male prisoners with a non psychotic psychiatric disorder .\
METHODS	This is a six month parallel randomized controlled study with sample size of 230 male prisoners .\
METHODS	Participants meeting inclusion and exclusion criteria were assigned to a study or control group by simple random allocation in which random allocation sequence was generated using a random number table .\
METHODS	Each individual study participant was involved in a daily program of SK&P for six weeks .\
METHODS	Each individual control participant was instructed to sit in an armchair with his eyes closed and gentle attention to their breath for duration of six weeks .\
METHODS	To be included in this study , a participant must be a male prisoner diagnosed to be suffering from a psychiatric disorder ( except psychosis and bipolar affective disorder [ BPAD ] ) by ICD-10 ( DCR ) criteria with age between 18 and 65 years .\
RESULTS	Majority of subjects were unemployed married individuals , educated until undermatric level and not having occupational skills of more than an unskilled labor level .\
RESULTS	Practicing SK&P for six weeks led to improvement in meanSD score of study participants in GAF , anxiety ( ANX ) , depressed mood ( DEP ) , positive well being ( PWB ) , general health ( GH ) , self control ( SC ) , vitality ( VT ) and total positive general well being ( PGWB ) .\
RESULTS	Change in meanSD score of study participants when compared with control participants was statistically significant in terms of GAF , ANX , DEP , PWB , GH and PGWB .\
RESULTS	Increase in SC and VT scores was statistically insignificant when compared with control participants .\
CONCLUSIONS	Practicing SK&P helps in improving GAF , PWB , GH and total PGWB of an individual .\
CONCLUSIONS	SK&P also causes significant reduction in anxiety and depression levels .\
CONCLUSIONS	Effect of SK&P on SC and VT is insignificant .\
\
###15249409\
OBJECTIVE	Our study aimed to evaluate the effect of preservation or elective division of the ilioinguinal nerve on pain and postoperative symptoms after open inguinal hernia repair with mesh .\
METHODS	Double-blind , randomized trial .\
METHODS	Four public , government-financed hospitals in Italy .\
METHODS	From January 1 , 1997 , to June 30 , 2002 , 813 patients with primary inguinal hernia were randomly allocated to undergo inguinal hernia repair either with ilioinguinal nerve preservation ( 408 patients , group A ) or elective transection ( 405 patients , group B ) .\
METHODS	Hernia repair with sutureless apposition of a polypropylene mesh .\
METHODS	The primary outcome was the evaluation of chronic pain 1 year after operation .\
METHODS	Secondary outcomes were postoperative symptoms assessment at 1 week and 1 , 6 , and 12 months after operation .\
METHODS	Telephone interview was performed 35.5 months ( range , 12-59 months ) after operation to assess the presence of chronic pain .\
RESULTS	Of the 302 group A and 291 group B patients who made an office visit 1 year postoperatively , pain was absent in 231 ( 76.5 % ) and 213 ( 73 % ) ( difference , 3.30 % ; 95 % confidence interval , -3.68 % to 10.28 % ) , mild in 55 ( 18 % ) and 60 ( 21 % ) , moderate in 11 ( 4 % ) and 9 ( 3 % ) , and severe in 5 ( 2 % ) and 9 ( 3 % ) , respectively ( P = .55 ; Pearson chi2 ( 3 ) test ) .\
RESULTS	At 1-month and 6-month follow-up visits , no difference was found between the 2 groups with respect to pain , but loss of pain or touch sensation were significantly greater when the ilioinguinal nerve was divided .\
RESULTS	One year after operation , the 2 groups were also comparable with respect to loss of pain sensation , but touch sensation remained decreased in group B.\
RESULTS	At telephone interview , the presence of chronic pain was similar in both groups .\
CONCLUSIONS	Pain after open hernia repair with polypropylene mesh is not affected by elective division of the ilioinguinal nerve ; sensory disturbances in the area of distribution of the transected nerve are significantly increased .\
\
###10840304\
BACKGROUND	Few data are available on the comparative performance of different types of sphincterotome .\
BACKGROUND	The aim of this study was to compare the efficacy of endoscopic sphincterotomy performed with either a reusable , single-lumen sphincterotome or a disposable triple-lumen instrument .\
METHODS	Seventy-seven consecutive adults requiring endoscopic sphincterotomy were prospectively and randomly assigned treatment with either a standard reusable single-lumen sphincterotome ( group A , n = 38 ) or a disposable triple-lumen sphincterotome with a guidewire ( group B , n = 39 ) .\
METHODS	The success rate , complications , and cost of the procedure per patient were compared .\
RESULTS	Deep cannulation was successful in 87 % of cases in each group and sphincterotomy was achieved in 76 % and 84 % of cases in group A and B , respectively ( NS ) .\
RESULTS	In the endoscopists ' opinion the two instruments performed almost equally well .\
RESULTS	Twelve procedure-related complications occurred : 5 ( all hemorrhages ) in group A and 7 ( 1 hemorrhage , 4 cases of pancreatitis and 2 of cholangitis ) in group B ( NS ) .\
RESULTS	Eight reusable sphincterotomes were used with a cost of $ 61 per patient , compared with 39 disposable sphincterotomes with a cost of $ 241 per patient ( p = 0.02 ) .\
CONCLUSIONS	A standard reusable sphincterotome is satisfactory for most endoscopic sphincterotomies , and yields a substantial cost savings without compromising the success or safety of the procedure .\
\
###16506900\
OBJECTIVE	To evaluate the effect of intratesticular administration of lidocaine on cardiovascular responses and cremaster muscle tension during castration of isoflurane-anesthetized stallions .\
METHODS	28 healthy stallions ( mean + / - SD age , 4.2 + / - 2.8 years ) with no testicular abnormalities that were scheduled for castration .\
METHODS	Each horse was given acepromazine ( 20 microg/kg , IM ) , romifidine ( 50 microg/kg , IV ) , and butorphanol ( 20 microg/kg , IV ) .\
METHODS	Anesthesia was induced with ketamine ( 2.5 mg/kg , IV ) and midazolam ( 50 microg/kg , IV ) and maintained with isoflurane ( 1.7 % end-tidal concentration ) .\
METHODS	After 10 minutes at a stable anesthetic plane , a needle was placed in each testicle and either no fluid or 15 mL of 2 % lidocaine was injected ; 10 minutes after needle placement , surgery was commenced .\
METHODS	Pulse rate and arterial blood pressures were measured invasively at intervals from 5 minutes prior to castration ( baseline ) until 5 minutes after the left spermatic cord was clamped .\
METHODS	The surgeon subjectively scored the degree of cremaster muscle tension .\
METHODS	In 2 horses , lidocaine labeled with radioactive carbon ( C ( 14 ) ) was used and testicular autoradiograms were obtained .\
RESULTS	Compared with baseline values , castration significantly increased blood pressure measurements ; intratesticular injection of lidocaine decreased this blood pressure response and cremaster muscle tension .\
RESULTS	In 2 horses , autoradiography revealed diffuse distribution of lidocaine into the spermatic cord but poor distribution into the cremaster muscle .\
CONCLUSIONS	In isoflurane-anesthetized stallions , intratesticular injection of lidocaine prior to castration appeared to decrease intraoperative blood pressure responses and cremaster muscle tension and may be a beneficial supplement to isoflurane anesthesia .\
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###21051656\
BACKGROUND	Currently available selective estrogen receptor modulators reduce the risk of breast cancer , but they are not widely used .\
BACKGROUND	In the Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene ( PEARL ) trial , lasofoxifene was shown to reduce the risk of estrogen receptor-positive ( ER + ) breast cancer , nonvertebral and vertebral fractures , coronary artery disease , and stroke , but the effects on total breast cancer ( invasive and ductal carcinoma in situ , ER + and estrogen receptor-negative [ ER - ] ) and ER + invasive breast cancer are unknown .\
METHODS	Postmenopausal women ( n = 8556 ) aged 59-80 years with low bone density and normal mammograms were randomly assigned to two doses of lasofoxifene ( 0.25 and 0.5 mg ) or placebo .\
METHODS	The primary endpoints of the PEARL trial were incidence of ER + breast cancer and nonvertebral fractures at 5 years .\
METHODS	A nested case-control study of 49 incident breast cancer case patients and 156 unaffected control subjects from the PEARL trial was performed to evaluate treatment effects on risk of total and ER + invasive breast cancer by baseline serum estradiol and sex hormone-binding globulin levels using logistic regression models .\
METHODS	Cox proportional hazards models were used to evaluate risk of total breast cancer and ER + invasive breast cancer using intention-to-treat analysis .\
METHODS	All statistical tests were two-sided .\
RESULTS	Breast cancer was confirmed in 49 women .\
RESULTS	Compared with placebo , 0.5 mg of lasofoxifene statistically significantly reduced the risk of total breast cancer by 79 % ( hazard ratio = 0.21 ; 95 % confidence interval [ CI ] = 0.08 to 0.55 ) and ER + invasive breast cancer by 83 % ( hazard ratio = 0.17 ; 95 % CI = 0.05 to 0.57 ) .\
RESULTS	The effects of 0.5 mg of lasofoxifene on total breast cancer were similar regardless of Gail score , whereas the effects were markedly stronger for women with baseline estradiol levels greater than the median ( odds ratio = 0.11 ; 95 % CI = 0.02 to 0.51 ) vs those with levels less than the median ( odds ratio = 0.78 ; 95 % CI = 0.16 to 3.79 ; P ( interaction ) = .04 ) .\
CONCLUSIONS	A 0.5-mg dose of lasofoxifene appears to reduce the risks of both total and ER + invasive breast cancer in postmenopausal women with osteoporosis .\
\
###17241419\
BACKGROUND	The axilla is particularly associated with body odor and putative pheromone production in humans .\
BACKGROUND	Although botulinum toxin type A ( BT-A ) is injected increasingly into the axillary skin to stop excessive sweating , its potential to control body odor is largely unexplored .\
OBJECTIVE	The objective was to measure the impact of BT-A on human axillary odor in an objective and reproducible fashion .\
METHODS	This study was a randomized , double-blind , placebo-controlled trial with 51 healthy volunteers receiving 50 U of BOTOX ( Allergan , Inc. ) in one axilla and placebo in the other .\
METHODS	Odor quality was assessed by treated subjects ( questionnaire ) as well as by independent raters who were exposed to blinded T-shirt samples .\
RESULTS	No major side effects occurred , and no subject withdrew from the study for medical reasons .\
RESULTS	Samples from the BT-A-treated side smelled less intense ( p < .001 ) and better ( p < .001 ) according to self-assessments .\
RESULTS	Likewise , independent raters found the BT-A-treated samples to smell less intense and better ( p < .001 ) .\
RESULTS	They preferred `` to work together with the respective person '' and found the odor `` more erotic '' ( p < .001 ) .\
CONCLUSIONS	Side-by-side comparison of odor samples ( T-shirt sniff test ) by independent raters showed that axillary odor in healthy individuals is significantly more appealing after BT-A injection .\
\
###12835212\
BACKGROUND	We sought to determine the potential of right ventricular VVI backup pacing to induce ventricular tachyarrhythmias in patients with implanted cardioverter-defibrillators .\
RESULTS	All consecutive patients presenting exclusively with pacemaker-induced tachycardias ( PITs ) were included in a prospective study using a crossover protocol .\
RESULTS	Patients were randomized to either group 1 ( augmentation of the baseline frequency of the pacemaker to 60 bpm ) or group 2 ( pacemaker turned off ) and were followed up for 1 year and then crossed over to the other programming , looking for reoccurrence of PIT .\
RESULTS	Of 150 consecutive patients , 39 ( 26 % ) had PIT , 13 of them exclusively ( 8.6 % ) .\
RESULTS	Forty of 1063 analyzed tachyarrhythmias of all the patients were PIT ( 3 % ) .\
RESULTS	Before inclusion in the study , the patients had 2.7 + / -0.9 PITs in 11 + / -6.5 months with their pacemakers programmed empirically at 42.3 bpm .\
RESULTS	During the study phase , no PIT occurred while the pacemaker was turned off , whereas programming to 60 bpm led to the recurrence of PIT in 5 of 6 patients ( 1.4 + / -0.6 per patient ) .\
RESULTS	At the end of the study , 9 patients underwent a prolonged follow-up with their pacemakers turned off , resulting in spontaneous episodes of ventricular tachycardia/fibrillation in 5 patients , but PITs were no longer observed .\
CONCLUSIONS	This crossover protocol proves the potential proarrhythmic effect of pacemaker stimulation in implantable cardioverter-defibrillator patients .\
CONCLUSIONS	Resulting PITs led to clinical symptoms and antitachycardia therapy by the implantable cardioverter-defibrillator .\
CONCLUSIONS	Thus , in patients presenting with PIT but without a pacemaker indication , the pacemaker feature should be turned off , or , alternatively , the longest possible escape interval should be programmed .\
\
###23391126\
BACKGROUND	The rate of elective surgeries varies dramatically by geography in the United States .\
BACKGROUND	For many of these surgeries , there is not clear evidence of their relative merits over alternate treatment choices and there are significant tradeoffs in short - and long-term risks and benefits of selecting one treatment option over another .\
BACKGROUND	Conditions and symptoms for which there is this lack of a single clear evidence-based treatment choice present great opportunities for patient and provider collaboration on decision making ; back pain and joint osteoarthritis are two such ailments .\
BACKGROUND	A number of decision aids are in active use to encourage this shared decision-making process .\
BACKGROUND	Decision aids have been assessed in formal studies that demonstrate increases in patient knowledge , increases in patient-provider engagement , and reduction in surgery rates .\
BACKGROUND	These studies have not widely demonstrated the added benefit of health coaching in support of shared decision making nor have they commonly provided strong evidence of cost reductions .\
BACKGROUND	In order to add to this evidence base , we undertook a comparative study testing the relative impact on health utilization and costs of active outreach through interactive voice response technology to encourage health coaching in support of shared decision making in comparison to mailed outreach or no outreach .\
BACKGROUND	This study focused on individuals with back pain or joint pain .\
METHODS	We conducted four waves of stratified randomized comparisons for individuals with risk for back , hip , or knee surgery who did not have claims-based evidence of one or more of five chronic conditions and were eligible for population care management services within three large regional health plans in the United States .\
METHODS	An interactive voice response ( IVR ) form of outreach that included the capability for individuals to directly connect with health coaches telephonically , known as AutoDialog ( ) , was compared to a control ( mailed outreach or natural levels of inbound calling depending on the study wave ) .\
METHODS	In total , the study include 24,167 adults with commercial and Medicare Advantage private coverage at three health plans and at risk for lumbar back surgery , hip repair/replacement , or knee repair/replacement .\
RESULTS	Interactive voice response outreach led to 10.7 ( P-value < .0001 ) times as many inbound calls within 30 days as the control .\
RESULTS	Over 180 days , the IVR group ( `` intervention '' ) had 67 percent ( P-value < .0001 ) more health coach communications and agreed to be sent 3.2 ( P-value < .0001 ) time as many DVD - and/or booklet-based decision aids .\
RESULTS	Targeted surgeries were reduced by 6.7 percent ( P-value = .6039 ) .\
RESULTS	Overall costs were lower by 4.9 percent ( P-value = .055 ) .\
RESULTS	Costs that were not related to maternity , cancer , trauma and substance abuse ( `` actionable costs '' ) were reduced by 6.5 percent ( P-value = .0286 ) .\
CONCLUSIONS	IVR with a transfer-to-health coach-option significantly increased levels of health coaching compared to mailed or no outreach and lead to significantly reduced actionable medical costs .\
CONCLUSIONS	Providing high levels of health coaching to individuals with these types of risks appears to have produced important levels of actionable medical cost reductions .\
CONCLUSIONS	We believe this impact resulted from more informed and engaged health care decision making .\
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###25265102\
BACKGROUND	Heart rate variability ( HRV ) has been used as a measure of stress and mental strain in surgeons .\
BACKGROUND	Low HRV has been associated with death and increased risk of cardiac events in the general population .\
BACKGROUND	The aim of this study was to clarify the effect of a 17-hour night shift on surgeons ' HRV .\
METHODS	Surgeons were monitored prospectively with an ambulatory electrocardiography device for 48 consecutive hours , beginning on a precall day and continuing through an on-call ( 17-h shift ) day .\
METHODS	We measured HRV by frequency domain parameters .\
RESULTS	We included 29 surgeons in our analysis .\
RESULTS	The median pulse rate was decreased precall ( median 64 , interquartile range [ IQR ] 56-70 beats per minute [ bpm ] ) compared with on call ( median 81 , IQR 70-91 bpm , p < 0.001 ) .\
RESULTS	Increased high-frequency ( HF ) activity was found precall ( median 199 , IQR 75-365 ms2 ) compared with on call ( median 99 , IQR 48-177 ms2 , p < 0.001 ) .\
RESULTS	The low-frequency : high-frequency ( LF : HF ) ratio was lower precall ( median 2.7 , IQR 1.9-3 .9 ) than on call ( median 4.9 , IQR 3.7-6 .5 , p < 0.001 ) .\
RESULTS	We found no correlation between the LF : HF ratio and performance in laparoscopic simulation .\
CONCLUSIONS	Surgeons working night shifts had a significant decrease in HRV and a significant increase in pulse rate , representing sympathetic dominance in the autonomic nervous system .\
BACKGROUND	NCT01623674 ( www.clinicaltrials.gov ) .\
\
###8686714\
OBJECTIVE	To explore the relationship between the administration of low-dose dopamine and outcomes in acute renal failure .\
METHODS	Two hundred and fifty-six patients with acute renal failure randomized to the placebo arm of a multicenter intervention trial were examined .\
METHODS	Independent correlates of low-dose ( arbitrarily defined as < 3 micrograms/kg/min ) and high-dose ( arbitrarily defined as > or = 3 micrograms/kg/min ) dopamine administration were identified .\
METHODS	The relative risks of death , and the combined outcome of death or dialysis , were estimated using proportional hazards regression with and without adjustment for potential confounding and bias .\
RESULTS	There were 93 ( 36 % ) deaths documented ; an additional 52 ( 20 % ) patients who survived required dialysis during the 60-day study period .\
RESULTS	The relative risk ( RR ) of death associated with the administration of low-dose dopamine was 1.11 ( 95 % confidence interval [ 95 % Cl ] 0.66 to 1.89 ) .\
RESULTS	The RR of death was modestly but not significantly reduced , after adjustment for the probability of treatment assignment and for relevant covariates ( RR 0.82 , 95 % Cl 0.42 to 1.60 ) .\
RESULTS	The RR of death or dialysis associated with the administration of low-dose dopamine was 1.10 ( 95 % Cl 0.71 to 1.71 ) .\
RESULTS	The RR of death or dialysis was attenuated by adjustment , but not significantly ( RR 0.95 , 95 % Cl 0.58 to 1.58 ) .\
CONCLUSIONS	There is insufficient evidence that the administration of low-dose dopamine improves survival or obviates the need for dialysis in persons with acute renal failure .\
CONCLUSIONS	The routine use of low-dose dopamine should be discouraged until a prospective , randomized , placebo-controlled trial establishes its safety and efficacy .\
\
###23967638\
OBJECTIVE	To compare the difference in the efficacy on spasmodic torticollis between matrix needling technique combined with puncturing `` Wuxin points '' and the local injection of botox type A.\
METHODS	Forty-two cases were randomized into an acupuncture group and a botox group , 21 cases in each one .\
METHODS	In the acupuncture group , the matrix needling technique was used and acupuncture was adopted at Fengchi ( GB 20 ) , `` Wuxin points '' [ Shuigou ( GV 26 ) , bilateral Laogong ( PC 8 ) and bilateral Yongquan ( KI 1 ) ] and local Ashi points .\
METHODS	In the botox group , botox type A was injected at several spots of local region .\
METHODS	The treatment course was 1 month in the two groups .\
METHODS	The efficacy in each weekend and the results of follow-up visit in half a year after treatment were compared between the two groups .\
RESULTS	In the 1st weekend , the markedly effective rate was 42.8 % ( 9/21 ) and the total effective rate was 90.5 % ( 19/21 ) in the botox group , which were better than those of 4.8 % ( 1/21 ) and 28.6 % ( 6/21 ) respectively in the acupuncture group ( both P < 0.01 ) .\
RESULTS	In the 2nd weekend , the markedly effective rate was 71.4 % ( 15/21 ) and the total effective rate was 95.2 % ( 20/21 ) in the botox group , which were better than those of 19.1 % ( 4/21 ) and 61.9 % ( 13/21 ) respectively in the acupuncture group ( both P < 0.01 ) .\
RESULTS	In the 3rd weekend , the markedly effective rate was 66.7 % ( 14/21 ) and the total effective rate was 95.2 % ( 20/21 ) in the botox group , which were better than those of 38.1 % ( 8/21 ) and 71.4 % ( 15/21 ) respectively in the acupuncture group ( both P < 0.05 ) .\
RESULTS	The markedly effective rate and the total effective rate were not different significantly between the two groups in the treatment of 1 month and the follow-up visit in half a year ( all P > 0.05 ) .\
RESULTS	There was no adverse reaction in the acupuncture group .\
RESULTS	There were 14 cases of adverse reactions in the botox group , in which 9 cases of neck muscular weakness and 5 cases of neck muscular pain .\
CONCLUSIONS	The treatment of matrix needling technique and combined with acupuncture at `` Wuxin points '' achieves the significant efficacy on spasmodic torticollis .\
CONCLUSIONS	Although the effect is not obtained as quickly as the local injection of botox , the efficacy of matrix needling technique is similar to that of botox in the treatment of 1 month and the follow-up visit in half a year .\
CONCLUSIONS	Moreover , this therapy has no adverse reaction .\
\
###25541155\
BACKGROUND	This study evaluates persistence and severity of docetaxel-induced neuropathy ( peripheral neuropathy ( PN ) ) and impact on health related quality of life in survivors from early-stage breast cancer .\
METHODS	One thousand and thirty-one patients with early-stage breast cancer , who received at least one cycle of docetaxel and provided information on PN during treatment , completed questionnaires on PN as an outcome ( Common Toxicity Criteria ( CTC ) scores , European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy 20 ( EORTC CIPN20 ) and EORTC Quality of Life Questionnaire ( QLQ ) - C30 ) after 1-3years .\
RESULTS	Upon completion of docetaxel treatment , 241 patients ( 23 % ) reported PN , grades 2-4 .\
RESULTS	PN persisted for 1-3years among 81 ( 34 % ) while PN regressed to grades 0-1 among 160 ( 66 % ) .\
RESULTS	Among 790 patients ( 77 % ) without PN , 76 ( 10 % ) developed PN 1-3years later while 714 ( 90 % ) stayed free from PN .\
RESULTS	Significant risk factors for persistent PN were age 55 ( p = 0.001 ) , maximum grade of PN during docetaxel treatment ( p < 0.0001 ) , persistent muscle and joint pain ( p < 0.0001 ) , stomatitis ( p = 0.047 ) and fatigue ( p = 0.001 ) .\
RESULTS	Persistent PN had a significant negative correlation with health-related quality of life ( HRQOL ) , functional scales and symptom scales .\
CONCLUSIONS	Overall , 15 % of breast cancer survivors treated with docetaxel report PN 1-3years after treatment with a significant negative impact on HRQOL .\
\
###11599829\
BACKGROUND	The purpose of our research was to evaluate the functional recovery and homeostasis of myocardium during simultaneous continuous retrograde and antegrade cardioplegia versus continuous retrograde cardioplegia .\
METHODS	Forty patients who underwent elective coronary artery bypass grafting ( CABG ) were prospectively assigned to two clinically matched groups and analyzed in respect to cardioplegia protocol .\
METHODS	Group I consisted of 24 patients who received continuous retrograde blood cardioplegia ; Group II consisted of 16 patients who received simultaneous continuous ante - and retrograde cardioplegia .\
METHODS	Hydrogen ion release , carbon dioxide , lactate concentration oxygen content , and oxygen extraction were measured from coronary sinus effluent and from the arterial line before and after cross-clamping of the aorta .\
METHODS	Median changes of these parameters were reported .\
METHODS	Cardiac output was measured and left and right ventricle stroke works were calculated .\
METHODS	Incidence of low cardiac output , ventricular fibrillation , raised cardiac enzymes , and ischemic changes on electrocardiogram ( ECG ) were noted .\
RESULTS	In the simultaneous group , oxygen content and oxygen extraction recovered well after cross-clamping .\
RESULTS	The same parameters did not recover to the same extent in the retrograde group .\
RESULTS	These changes were notable between groups .\
RESULTS	Hydrogen ion , carbon dioxide , and lactate releases were comparable between groups .\
RESULTS	Trend toward better recovery of left ventricle stroke work index was encountered in the simultaneous group .\
CONCLUSIONS	Viability of myocardium measured with oxygen utilization and functional recovery is better preserved with simultaneous antegrade and retrograde cardioplegia .\
CONCLUSIONS	However , there is no difference in anaerobic metabolism markers .\
CONCLUSIONS	Thus simultaneous ante - and retrograde cardioplegia is probably advantageous over retrograde alone .\
\
###10994901\
OBJECTIVE	The purpose of this study was to determine , in a randomized clinical trial of 439 individuals with knee osteoarthritis , the incremental cost-effectiveness of aerobic versus weight resistance training , compared with an education control intervention .\
METHODS	Cost estimates of the intervention were based upon the cost of purchasing from the community similar services to provide exercise or health education .\
METHODS	Effect at 18 months was measured using several variables , including : self-reported disability score , 6-min walking distance , stair climb , lifting and carrying task , car task , and measures of pain frequency and pain intensity on ambulation and transfer .\
RESULTS	The total cost of the educational intervention was $ 343.98 per participant .\
RESULTS	The aerobic exercise intervention cost $ 323.55 per participant , and the resistance training intervention cost $ 325.20 per participant .\
RESULTS	On all but two of the outcome variables , the incremental savings per incremental effect for the resistance exercise group was greater than for the aerobic exercise group .\
CONCLUSIONS	The data obtained from this study suggest that , compared with an education control , resistance training for seniors with knee osteoarthritis is more economically efficient than aerobic exercise in improving physical function .\
CONCLUSIONS	However , the magnitude of the difference in efficiency between the two approaches is small .\
\
###19945275\
BACKGROUND	The incidence of pruritus after elective caesarean section under spinal anaesthesia with subarachnoid morphine may be 60-100 % , and is a common cause of maternal dissatisfaction .\
BACKGROUND	Ondansetron has been shown to reduce pruritus but the effect is short-lived .\
BACKGROUND	The objective of this randomized double-blind trial was to evaluate the anti-pruritic efficacy of granisetron compared with ondansetron .\
METHODS	Eighty ASA I or II women undergoing elective caesarean section received spinal anaesthesia with 0.5 % hyperbaric bupivacaine 10 mg , fentanyl 25 microg and preservative-free morphine 150 microg .\
METHODS	After delivery of the baby and clamping of the umbilical cord , they were randomised to receive granisetron 3mg i.v. ( group G ) or ondansetron 8 mg i.v. ( group O ) .\
RESULTS	The two groups were similar for age , gestational age , height and weight .\
RESULTS	According to visual analogue pruritus scores , patients in group G experienced less pruritus at 8h ( P = 0.003 ) and 24h ( P = 0.01 ) .\
RESULTS	Fewer patients in group G ( n = 8 ) than group O ( n = 18 ) required rescue anti-pruritic medication ( P = 0.03 ) .\
RESULTS	Satisfaction scores were also higher in group G than in group O ( P = 0.03 ) .\
RESULTS	There was no difference in overall incidence of pruritus , nausea and vomiting , and visual analogue pain scores between the two groups .\
CONCLUSIONS	Administration of granisetron 3mg i.v. reduces the severity of pruritus and the use of rescue anti-pruritic medication , and improves satisfaction but does not reduce the overall incidence of pruritus in women who have received subarachnoid morphine 150 microg compared to ondansetron 8 mg i.v.\
\
###20203321\
OBJECTIVE	The purpose of our study was to investigate the effects of different doses of neuromuscular electrical stimulation ( NMES ) on upper-extremity function in acute stroke patients with severe motor deficit .\
METHODS	Sixty-six acute stroke patients were randomized to 3 groups : high NMES , low NMES , or control .\
METHODS	The low-NMES group received 30 minutes of stimulation per day , and the high-NMES group received 60 minutes per day , for 4 weeks .\
METHODS	The Fugl-Meyer Motor Assessment Scale , Action Research Arm Test , and Motor Activity Log were used to assess the patients at baseline , 4 weeks , and 12 weeks post baseline ( follow-up ) .\
RESULTS	Both NMES groups showed significant improvement on Fugl-Meyer Motor Assessment and Action Research Arm Test scales compared with the control group at week 4 and follow-up .\
RESULTS	The high-NMES group showed treatment effects similar to those of the low-NMES group .\
CONCLUSIONS	Higher and lower doses of NMES led to similar improvements in motor function .\
CONCLUSIONS	A minimum of 10 hours of NMES in combination with regular rehabilitation may improve recovery of arm function in stroke patients during the acute stage .\
\
###22966124\
BACKGROUND	Plasmodium vivax forms long-lasting hypnozoites in the liver .\
BACKGROUND	How much they contribute to the burden of P. vivax malaria in children living in highly endemic areas is unknown .\
METHODS	In this study , 433 Papua New Guinean children aged 1-5 years were Randomized to receive artesunate ( 7 days ) plus primaquine ( 14 days ) , artesunate alone or no treatment and followed up actively for recurrent Plasmodium infections and disease for 40 weeks .\
RESULTS	Treatment with artesunate-primaquine reduced the risk of P. vivax episodes by 28 % ( P = .042 ) and 33 % ( P = .015 ) compared with the artesunate and control arms , respectively .\
RESULTS	A significant reduction was observed only in the first 3 months of follow-up ( artesunate-primaquine vs control , -58 % [ P = .004 ] ; artesunate-primaquine vs artesunate , -49 % [ P = .031 ] ) with little difference thereafter .\
RESULTS	Primaquine treatment also reduced the risk of quantitative real-time polymerase chain reaction - and light microscopy-positive P. vivax reinfections by 44 % ( P < .001 ) and 67 % ( P < .001 ) , respectively .\
RESULTS	Whereas primaquine treatment did not change the risk of reinfection with Plasmodium falciparum , fewer P. falciparum clinical episodes were observed in the artesunate-primaquine arm .\
CONCLUSIONS	Hypnozoites are an important source of P. vivax infection and contribute substantially to the high burden of P. vivax disease observed in young Papua New Guinean children .\
CONCLUSIONS	Even in highly endemic areas with a high risk of reinfection , antihypnozoite treatment should be given to all cases with parasitologically confirmed P. vivax infections .\
\
###9593559\
BACKGROUND	Reperfusion therapy for myocardial infarction , understood to reduce mortality by preserving left ventricular function , was initially expected to provide increasing benefits over time .\
BACKGROUND	Surprisingly , large controlled thrombolysis trials demonstrated maximum benefit at 4 to 6 weeks with no subsequent increased treatment advantage .\
BACKGROUND	Such studies , however , compared groups by assigned treatment , not physiological effectiveness .\
RESULTS	We calculated 2-year survival differences among 2431 myocardial infarction patients according to early infarct artery patency and outcome left ventricular ejection fraction using Kaplan-Meier curves .\
RESULTS	Hazard ratios for significant survival determinants were derived from Cox regression models .\
RESULTS	Two-year vital status ( minimum , 688 days ) was determined in 2375 patients ( 97.7 % ) .\
RESULTS	A substantial mortality advantage for early complete reperfusion ( Thrombolysis in Myocardial Infarction [ TIMI ] grade 3 ) and for preserved ejection fraction occurred beyond 30 days .\
RESULTS	The unadjusted hazard ratio for the TIMI 3 group compared with lesser grades at 30 days was 0.57 ( 95 % confidence interval [ CI ] , 0.35 to 0.94 ) and 30 days to > or = 688 days was 0.39 ( 95 % CI , 0.22 to 0.69 ) .\
RESULTS	Consequently , early TIMI 3 flow was associated with approximately a 3 patient per 100 mortality reduction the first month with an additional 5 lives per 100 from 30 days to 2 years .\
RESULTS	For ejection fraction > 40 % compared with < or = 40 % , the unadjusted hazard ratio was 0.25 ( 95 % CI , 0.16 to 0.37 ) at 30 days and 0.22 ( 95 % CI , 0.15 to 0.33 ) after 30 days through 2 years ( lives saved , approximately 9 and 11 per 100 , respectively ) .\
CONCLUSIONS	Successful reperfusion and myocardial salvage produce significant mortality benefits that are amplified beyond the initial 30 days .\
\
###21734179\
OBJECTIVE	The therapeutic effects of 4-aminopyridine ( 4AP ) were investigated in a randomized , double-blind , crossover trial in 10 subjects with familial episodic ataxia with nystagmus .\
METHODS	After randomization , placebo or 4AP ( 5 mg 3 times daily ) was administered for 2 3-month-long treatment periods separated by a 1-month-long washout period .\
METHODS	The primary outcome measure was the number of ataxia attacks per month ; the secondary outcome measures were the attack duration and patient-reported quality of life ( Vestibular Disorders Activities of Daily Living Scale [ VDADL ] ) .\
METHODS	Nonparametric tests and a random-effects model were used for statistical analysis .\
RESULTS	The diagnosis of episodic ataxia type 2 ( EA2 ) was genetically confirmed in 7 subjects .\
RESULTS	Patients receiving placebo had a median monthly attack frequency of 6.50 , whereas patients taking 4AP had a frequency of 1.65 ( p = 0.03 ) .\
RESULTS	Median monthly attack duration decreased from 13.65 hours with placebo to 4.45 hours with 4AP ( p = 0.08 ) .\
RESULTS	The VDADL score decreased from 6.00 to 1.50 ( p = 0.02 ) .\
RESULTS	4AP was well-tolerated .\
CONCLUSIONS	This controlled trial on EA2 and familial episodic ataxia with nystagmus demonstrated that 4AP decreases attack frequency and improves quality of life .\
METHODS	This crossover study provides Class II evidence that 4AP decreases attack frequency and improves the patient-reported quality of life in patients with episodic ataxia and related familial ataxias .\
\
###25589191\
BACKGROUND	We aimed to assess the effect of afatinib on overall survival of patients with EGFR mutation-positive lung adenocarcinoma through an analysis of data from two open-label , randomised , phase 3 trials .\
METHODS	Previously untreated patients with EGFR mutation-positive stage IIIB or IV lung adenocarcinoma were enrolled in LUX-Lung 3 ( n = 345 ) and LUX-Lung 6 ( n = 364 ) .\
METHODS	These patients were randomly assigned in a 2:1 ratio to receive afatinib or chemotherapy ( pemetrexed-cisplatin [ LUX-Lung 3 ] or gemcitabine-cisplatin [ LUX-Lung 6 ] ) , stratified by EGFR mutation ( exon 19 deletion [ del19 ] , Leu858Arg , or other ) and ethnic origin ( LUX-Lung 3 only ) .\
METHODS	We planned analyses of mature overall survival data in the intention-to-treat population after 209 ( LUX-Lung 3 ) and 237 ( LUX-Lung 6 ) deaths .\
METHODS	These ongoing studies are registered with ClinicalTrials.gov , numbers NCT00949650 and NCT01121393 .\
RESULTS	Median follow-up in LUX-Lung 3 was 41 months ( IQR 35-44 ) ; 213 ( 62 % ) of 345 patients had died .\
RESULTS	Median follow-up in LUX-Lung 6 was 33 months ( IQR 31-37 ) ; 246 ( 68 % ) of 364 patients had died .\
RESULTS	In LUX-Lung 3 , median overall survival was 28.2 months ( 95 % CI 24.6-33 .6 ) in the afatinib group and 28.2 months ( 20.7-33 .2 ) in the pemetrexed-cisplatin group ( HR 0.88 , 95 % CI 0.66-1 .17 , p = 0.39 ) .\
RESULTS	In LUX-Lung 6 , median overall survival was 23.1 months ( 95 % CI 20.4-27 .3 ) in the afatinib group and 23.5 months ( 18.0-25 .6 ) in the gemcitabine-cisplatin group ( HR 0.93 , 95 % CI 0.72-1 .22 , p = 0.61 ) .\
RESULTS	However , in preplanned analyses , overall survival was significantly longer for patients with del19-positive tumours in the afatinib group than in the chemotherapy group in both trials : in LUX-Lung 3 , median overall survival was 33.3 months ( 95 % CI 26.8-41 .5 ) in the afatinib group versus 21.1 months ( 16.3-30 .7 ) in the chemotherapy group ( HR 0.54 , 95 % CI 0.36-0 .79 , p = 0.0015 ) ; in LUX-Lung 6 , it was 31.4 months ( 95 % CI 24.2-35 .3 ) versus 18.4 months ( 14.6-25 .6 ) , respectively ( HR 0.64 , 95 % CI 0.44-0 .94 , p = 0.023 ) .\
RESULTS	By contrast , there were no significant differences by treatment group for patients with EGFR Leu858Arg-positive tumours in either trial : in LUX-Lung 3 , median overall survival was 27.6 months ( 19.8-41 .7 ) in the afatinib group versus 40.3 months ( 24.3-not estimable ) in the chemotherapy group ( HR 1.30 , 95 % CI 0.80-2 .11 , p = 0.29 ) ; in LUX-Lung 6 , it was 19.6 months ( 95 % CI 17.0-22 .1 ) versus 24.3 months ( 19.0-27 .0 ) , respectively ( HR 1.22 , 95 % CI 0.81-1 .83 , p = 0.34 ) .\
RESULTS	In both trials , the most common afatinib-related grade 3-4 adverse events were rash or acne ( 37 [ 16 % ] of 229 patients in LUX-Lung 3 and 35 [ 15 % ] of 239 patients in LUX-Lung 6 ) , diarrhoea ( 33 [ 14 % ] and 13 [ 5 % ] ) , paronychia ( 26 [ 11 % ] in LUX-Lung 3 only ) , and stomatitis or mucositis ( 13 [ 5 % ] in LUX-Lung 6 only ) .\
RESULTS	In LUX-Lung 3 , neutropenia ( 20 [ 18 % ] of 111 patients ) , fatigue ( 14 [ 13 % ] ) and leucopenia ( nine [ 8 % ] ) were the most common chemotherapy-related grade 3-4 adverse events , while in LUX-Lung 6 , the most common chemotherapy-related grade 3-4 adverse events were neutropenia ( 30 [ 27 % ] of 113 patients ) , vomiting ( 22 [ 19 % ] ) , and leucopenia ( 17 [ 15 % ] ) .\
CONCLUSIONS	Although afatinib did not improve overall survival in the whole population of either trial , overall survival was improved with the drug for patients with del19 EGFR mutations .\
CONCLUSIONS	The absence of an effect in patients with Leu858Arg EGFR mutations suggests that EGFR del19-positive disease might be distinct from Leu858Arg-positive disease and that these subgroups should be analysed separately in future trials .\
BACKGROUND	Boehringer Ingelheim .\
\
###15643212\
OBJECTIVE	We studied the role of open surgery versus percutaneous nephrolithotomy ( PCNL ) in the treatment of complete staghorn stones in a prospective randomized manner .\
METHODS	A total of 79 patients with 88 complete staghorn stones , defined as filling the entire collecting system or at least 80 % of it , were prospectively randomized for PCNL ( 43 ) or open surgery ( 45 ) .\
METHODS	Intraoperative and postoperative morbidity , operative time , hospital stay , and stone clearance at discharge home and followup were compared for both methods .\
METHODS	Patients with significant residuals in both groups were subjected to extracorporeal shock wave lithotripsy ( Dornier Medical Systems , Inc. , Marietta , Georgia ) on an outpatient basis .\
METHODS	Followup was completed for all cases with a mean duration + / - SD of 4.9 + / - 2.5 months ( range 3 to 14 ) .\
METHODS	Renal function was evaluated by Tc-mercaptoacetyltriglycine renogram before and after treatment in both groups .\
RESULTS	Intraoperative complications in terms of bleeding requiring blood transfusion , and pleural , vascular or ureteral injuries were recorded in 7 patients ( 16.3 % ) in the PCNL and 17 ( 37.8 % ) in the open surgery groups , a difference of significant value ( p < 0.05 ) .\
RESULTS	Major postoperative complications including massive hematuria requiring blood transfusion , septicemia , urinary leakage and wound infection were observed in 8 patients ( 18.6 % ) in the PCNL group and in 14 ( 31.1 % ) in the open surgery group , a difference of no significant value .\
RESULTS	PCNL was associated with shorter operative time ( 127 + / - 30 vs 204 + / - 31 minutes , p < 0.001 ) , shorter hospital stay ( 6.4 + / - 4.2 vs 10 + / - 4.2 days , p < 0.001 ) and earlier return to work ( 2.5 + / - 0.8 vs 4.1 + / - 1 weeks , p < 0.001 ) .\
RESULTS	On the other hand both treatment groups were comparable in regard to stone-free rates at discharge home ( 49 % vs 66 % ) and at followup ( 74 % vs 82 % ) .\
RESULTS	At followup renal function improved or remained stable in 91 % and 86.7 % in the PCNL and open surgery groups , respectively .\
CONCLUSIONS	PCNL is a valuable treatment option for complete staghorn stones with a stone-free rate approaching that of open surgery .\
CONCLUSIONS	Moreover , it has the advantages of lower morbidity , shorter operative time , shorter hospital stay and earlier return to work .\
\
###10470628\
OBJECTIVE	To determine whether pulse wave velocity ( PWV ) , which is a useful indicator of cardiovascular disease , can predict the hemodynamic responses to anesthesia and surgical stimulation in surgical patients .\
METHODS	Prospective , randomized study .\
METHODS	Operating rooms at a university hospital .\
METHODS	30 ASA physical status I and II female patients presenting for elective gynecologic surgery .\
METHODS	Patients who received one of the following anesthesia techniques were studied ; isoflurane , sevoflurane and sevoflurane with nitrous oxide ( N2O ) .\
RESULTS	Patients underwent preoperative PWV measurements using an automatic PWV measurement device .\
RESULTS	Systolic blood pressure and heart rate levels were recorded at baseline , during anesthesia , and at skin incision .\
RESULTS	PWV had no significant correlation with percent changes of systolic blood pressure or heart rate , even after controlling the choice of anesthetic drugs .\
CONCLUSIONS	Preoperative PWV fails to predict hemodynamic responses to anesthesia and to surgical stimulation .\
\
###10551573\
BACKGROUND	Despite new anesthetic drugs and antiemetics , particularly 5-hydroxytryptamines , the incidence of postoperative nausea or vomiting remains between 20 % and 70 % .\
BACKGROUND	The authors tested the hypothesis that supplemental perioperative oxygen administration reduces the incidence of postoperative nausea or vomiting .\
METHODS	Patients undergoing colon resection were anesthetized with fentanyl and isoflurane .\
METHODS	During and for 2 h after surgery they were randomly assigned to ( 1 ) 30 % oxygen , balance nitrogen ( n = 119 ) ; or ( 2 ) 80 % oxygen , balance nitrogen ( n = 112 ) .\
METHODS	The incidence of nausea or vomiting during the first 24 postoperative hours was evaluated by nurses blinded to group assignment and oxygen concentration .\
METHODS	Data were analyzed with unpaired t or Mann-Whitney U tests .\
METHODS	Results are presented as means + / - SD ; P < 0.05 was considered significant .\
RESULTS	Factors known to influence nausea and vomiting were comparable in the two groups .\
RESULTS	Perioperative oxygen saturation was well within normal limits in each treatment group ; saturations the first postoperative morning were comparable in each group .\
RESULTS	Supplemental oxygen reduced the incidence of postoperative nausea or vomiting from 30 % in the patients given 30 % oxygen to 17 % in those given 80 % oxygen ( P = 0.027 ) .\
CONCLUSIONS	Supplemental oxygen reduced the incidence of postoperative nausea or vomiting nearly twofold after colorectal surgery .\
CONCLUSIONS	The mechanism by which oxygen administration reduces the incidence of these postoperative sequelae remains unknown but may be related to subtle intestinal ischemia .\
CONCLUSIONS	Because oxygen is inexpensive and essentially risk-free , supplemental oxygen appears to be an effective method of reducing postoperative nausea and vomiting .\
\
###23034424\
OBJECTIVE	The short-term and overnight effect of three treatment regimens on oral halitosis were investigated : toothbrushing with a reference toothpaste , toothbrushing with reference toothpaste and tongue cleaning , and toothbrushing and tongue cleaning with a tooth-and-tongue gel .\
METHODS	Fifty-four subjects meeting the inclusion criteria for bad breath were enrolled in the study .\
METHODS	All subjects received each of the three treatment regimens in a balanced design .\
METHODS	Efficacy was assessed by organoleptic ratings and volatile sulfur compound ( VSC ) measurements 5 and 60 minutes after first application and overnight after 7 days of repeated use .\
RESULTS	The combination of toothbrushing and tongue cleaning with tooth-and-tongue gel provided the best results in terms of organoleptic ratings and VSC measurements at all time points compared to the other treatment regimens .\
CONCLUSIONS	The use of tooth and tongue gel for both toothbrushing and tongue cleaning showed a positive short-term and overnight effects after 7 days of use .\
CONCLUSIONS	This treatment regimen is a promising approach to control halitosis .\
\
###8568487\
OBJECTIVE	The initial aim of this study was to evaluate the possibility of influencing atherosclerosis in hyperlipidaemic renal transplant patients by lowering blood lipids with gemfibrozil treatment .\
METHODS	Although this double-blind , randomized trial was stopped after 6 months owing to the suspicion of drug interference , we report here on the results of baseline ultrasonographic examinations .\
METHODS	The outpatient clinic at the Department of Transplantation Surgery , Huddinge University Hospital , Huddinge , Sweden .\
METHODS	The carotid arteries were examined in 16 out of the 19 kidney transplant patients included in the study using an ultrasonographic duplex scanner .\
METHODS	Plaque occurrence and the common carotid intima-media thickness of the renal transplant recipients were compared to the same parameters in a normotensive control group of approximately the same age from a previous study .\
RESULTS	An increased prevalence of plaque ( 75 % of the patients having plaque on one or both sides ) was seen in the hyperlipidaemic renal transplant patients in comparison with the control group ( 16 % ; P < 0.001 ) .\
RESULTS	The common carotid intima-media complex was thicker ( P < 0.05 ) , and the lumen diameter and the calculated cross-sectional intima-media area were greater ( P < 0.01-0 .001 ) in the transplant recipients .\
CONCLUSIONS	Markedly increased atherosclerotic wall changes are seen in the carotid arteries of patients with hyperlipidaemia after renal transplantation .\
\
###17716288\
BACKGROUND	Medical skin care products are topical preparations with mainly moisturizing properties .\
BACKGROUND	A new line of medical skin products with an excellent tolerability profile and improved hydration for dry skin has been developed , but beneficial effects have not yet been investigated on damaged skin .\
OBJECTIVE	To investigate if these products maintain barrier function and hydration status , improve subjective symptoms due to irritant contact dermatitis and to prove their tolerability on damaged skin .\
METHODS	Single-centre , blinded , randomized , controlled study in 20 healthy Caucasian women .\
METHODS	5 % sodium lauryl sulphate solution was used to induce skin irritation .\
METHODS	Two sites on the inside surface of both forearms of each subject were treated daily for 5 days ( irritation period ) .\
METHODS	Lipo Cream , Lipo Milk ( water-in-oil emulsions ) and Lipo Ointment ( water-free formulation ) were applied twice daily to three of the four test sites on days 1-5 .\
METHODS	The fourth site was used as a control .\
METHODS	Visual readings , subjective symptom assessments , transepidermal water loss ( TEWL ) and colorimetric measurements , corneometry and skin microrelief macrophotographies were done on days 1-6 .\
RESULTS	On day 6 , TEWL was increased vs baseline on all sites ; however , TEWL with Lipo Cream or Lipo Ointment was significantly lower than control .\
RESULTS	At day 6 , skin capacitance was 94 % , 100 % and 85 % of baseline value for the cream , milk and ointment , respectively , versus 72 % for control .\
RESULTS	All test products were well tolerated .\
CONCLUSIONS	Lipo Line products showed both protective properties against epidermal dysfunction and significant hydrating effect .\
\
###20585297\
OBJECTIVE	Weight reduction strategies usually include diet and regular physical activity .\
OBJECTIVE	A very low-carbohydrate and high protein diet ( VLCD ) may be preferred instead of a low energy conventional diet ( CONV ) .\
OBJECTIVE	The effects of VLCD on strength performance are yet to be understood .\
OBJECTIVE	Aim of the study is to determine the effects of two different restrictive diets on strength performance .\
METHODS	Sedentary women were assigned to either a VLCD ( < 40 g carbohydrate ; n = 12 ) or a CONV diet ( 500 to 800 kcal restrictive ; 48 % , 22 % and 30 % from carbohydrate , protein and fat , respectively ; n = 12 ) .\
METHODS	Knee extension isokinetic strength tests ( 3 yen 15 reps at 60 degrees .\
METHODS	s-1 , with 90 or 180 s rest interval between sets ) were performed prior and after a one week diet period .\
RESULTS	Both groups reduced body mass ( VLCD : -2.6 + / -1.0 % vs. CONV : -1.9 + / -1.3 % ; P < 0.05 ) , with no between diets effect .\
RESULTS	The sum of the total work in three sets ( ATW ) was 4850 + / -1002 J vs. 4801 + / -973 J with 90 s rest interval , and 4812 + / -1174 J vs. 4812 + / -1210 J with 180 s rest interval , respectively , in the pre vs. post-VLCD period .\
RESULTS	For CONV , values were 4709 + / -729 J vs. 4530 + / -996 J with 90 s rest interval , and 4760 + / -732 J vs. 4816 + / -702 J with 180 s rest interval , respectively , in the pre vs. post-CONV treatment .\
RESULTS	No significant differences were detected in the ATW between groups .\
CONCLUSIONS	Short-term hypoenergetic diets , irrespective of the carbohydrate content , seem to reduce significantly body mass , but do not impair acute strength performance .\
\
###21672053\
BACKGROUND	Allergic symptoms are generally caused by exposure to substances to which people have become sensitized .\
BACKGROUND	Associated with this is an ` unbalanced ' Th1/Th2 immune response with T cell responses skewed towards the production of Th2 cytokines , IL-4 , 5 , and 13 and high levels of IgE antibodies .\
BACKGROUND	Current immune modulating therapies require the use of allergens , carrying the risk to induce potentially severe allergic reactions .\
OBJECTIVE	Goal of the present study was to assess the safety and efficacy of an allergen-free immune modulator in patients suffering from perennial allergy .\
METHODS	In order to be protected from immediate degradation upon injection , a toll-like receptor 9 ( TLR9 ) agonist was packaged into virus-like particles .\
METHODS	These nanoparticles loaded with TLR9 ligands ( CYT003-QbG10 ) were injected six times , at weekly intervals , into patients with house dust mite allergy in an attempt to ameliorate allergic symptoms by modifying the immune response towards allergens .\
METHODS	Two different doses were compared against placebo in this double-blind , randomized phase IIb study ( n = 299 ) .\
METHODS	Public trial registry : http://clinicaltrials.gov ( NCT00800332 ) .\
RESULTS	The treatment was safe and generally well tolerated .\
RESULTS	Rhinoconjunctivitis symptoms were significantly lower in patients treated with high dose of CYT003-QbG10 as compared with placebo ( scores 0.31 vs. 0.52 , P = 0.04 ) based on a standardized average combined symptom and medication score .\
RESULTS	Furthermore , patients in the high dose group reported a significantly better quality of life score post-treatment than patients on placebo ( scores 0.71 vs. 1.21 , P = 0.02 ) .\
RESULTS	The conjunctival provocation test revealed a median 10-fold increase in allergen tolerance in the high dose group while in the placebo group it remained unchanged .\
CONCLUSIONS	Treatment with high-dose CYT003-QbG10 improved disease symptoms and reduced medication use in allergic individuals thus providing first evidence for a new potential immunotherapeutic .\
\
###20375791\
OBJECTIVE	In this study , we investigated the prevalence of human papillomavirus 16 ( HPV-16 ) variants in Honduran women with normal cytology and with dysplasia and cervical cancer .\
METHODS	Samples identified as positive for HPV-16 by SPF10-LiPA were tested for intratypic subtypes and variants by analysis of the E6/E7 region using a novel reverse hybridization assay ( line probe assay ) .\
RESULTS	We found that most infections in all clinical groups belong to the E6 European variants , suggesting that HPV-16 non-European variants do not represent an additional factor associated with increased occurrence of high-grade cervical lesions in the studied population .\
RESULTS	Among the 106 HPV-16-positive women analyzed , E-350G was the most prevalent variant in all different disease stages , being present in 18 % of cervical cancer , 13 % of cervical intraepithelial neoplasia grade III ( CIN III ) , 5 % of CIN II , 5 % of CIN I , and 20 % of control samples .\
RESULTS	Mixed variants of HPV-16 infections were detected in 7.7 % of the samples , mostly in women with normal cytology .\
CONCLUSIONS	This study shows for the first time the diversity of HPV-16 variants in cervical samples of Honduran women .\
\
###17125604\
OBJECTIVE	To evaluate the efficacy and safety of pegylated interferon alpha 2a ( PEG-IFN alpha-2a ) in treating patients with chronic hepatitis B.\
METHODS	Seventy-two patients with chronic hepatitis B were assigned to a PEG-IFN alpha-2a ( experimental ) group ( n = 42 ) and an interferon alpha ( control ) group ( n = 30 ) randomly .\
METHODS	Each patient in the experimental group received 180 microg PEG-IFN alpha-2a every week .\
METHODS	Each patient in the control group received 500 MU interferon alpha every day .\
METHODS	All the patients were treated for 48 weeks , and then were followed for another 48 weeks with no treatment .\
RESULTS	At the end of the 12th week , the rate of HBeAg negative cases was 30 % in the PEG-IFN alpha-2a group , which was much higher than in the control group ( x2 = 4.162 , P < 0.05 ) .\
RESULTS	The values of HBeAg and the log value of HBV DNA in the PEG-IFN alpha-2a group were much lower than the values before the treatment ( t = 2.689 , t = 4.080 , P < 0.01 ) , but there was no difference between before and after treatment in the control group ( t = 1.229 , t = 1.009 , P > 0.05 ) .\
RESULTS	At the end of the 24th week , the rate of HBeAg negative cases in the PEG-IFN alpha-2a group was much higher than that in the control group ( x2 = 6.190 , P < 0.05 ) .\
RESULTS	The value of HBeAg and the log value of HBV DNA in the PEG-IFN alpha-2a group were much lower than in the control group ( t = 2.215 , t = 2.122 , P < 0.05 ) .\
RESULTS	At the end of the 48th week , besides the reduction mentioned above , the rate of cases with HBeAg/antiHBe seroconversion and normalization of ALT and complete responsiveness in the PEG-IFN alpha-2a group were all much higher than those in the control group ( x2 = 5.771 , x2 = 5.617 , x2 = 5.308 , P < 0.05 ) .\
RESULTS	At the end of 48 weeks with no treatment , all the parameters mentioned above in the PEG-IFN alpha-2a group were much better than those in the control group and they remained so , but they were different in the control group ( x2 = 11.943 , t = 3.439 , t = 6.111 , x2 = 9.930 , x2 = 9.522 , x2 = 7.920 , P < 0.01 ) .\
RESULTS	Nine patients in the PEG-IFN alpha-2a group had liver biopsies before their treatment and also at the end of their treatment .\
RESULTS	The expressions of HBsAg and HBcAg were decreased at the end of the treatment .\
RESULTS	The rate of expression of HBsAg in the liver tissues before the treatment was 88.9 % but only 22.2 % at the end of the treatment ( x2 = 8.001 , P < 0.01 ) .\
RESULTS	The rate of expression of HBcAg in the livers before treatment was 66.7 % but only 33.3 % at the end of the treatment .\
RESULTS	Before and at the end of the PEG-IFN alpha-2a treatment , there were no significant changes in the degrees of inflammation and fibrosis and the quantity of collagen in the liver tissues .\
RESULTS	Three patients in the PEG-IFN alpha-2a group ( 10 % ) were HbsAg negative .\
RESULTS	Two of them were found so at the end of 32 weeks with treatment and one patient was found at the end of 24 weeks with no treatment , but there were no HBsAg negative patients in the control group .\
RESULTS	The adverse reactions that occurred in the PEG-IFN alpha-2a and in the control groups were similar .\
CONCLUSIONS	PEG-IFN alpha-2a was effective in inhibiting HBV replication .\
CONCLUSIONS	The effect of PEG-IFN alpha-2a was lasting .\
CONCLUSIONS	PEG-IFN alpha-2a was well tolerated during our treatment .\
\
###22356933\
BACKGROUND	The consumption of foods containing probiotic and prebiotic ingredients is growing consistently every year , and in view of the limited number of studies investigating their effect in the elderly .\
OBJECTIVE	The objective of this study was to evaluate the effect of the consumption of a symbiotic shake containing Lactobacillus acidophilus , Bifidobacterium bifidum and fructooligosaccharides on glycemia and cholesterol levels in elderly people .\
METHODS	A randomized , double-blind , placebo-controlled study was conducted on twenty volunteers ( ten for placebo group and ten for symbiotic group ) , aged 50 to 60 years .\
METHODS	The criteria for inclusion in the study were : total cholesterol > 200 mg/dL ; triglycerides > 200 mg/dL and glycemia > 110 mg/dL .\
METHODS	Over a total test period of 30 days , 10 individuals ( the symbiotic group ) consumed a daily dose of 200 mL of a symbiotic shake containing 10 ( 8 ) UFC/mL Lactobacillus acidophilus , 10 ( 8 ) UFC/mL Bifidobacterium bifidum and 2 g oligofructose , while 10 other volunteers ( the placebo group ) drank daily the same amount of a shake that did not contain any symbiotic bacteria .\
METHODS	Blood samples were collected 15 days prior to the start of the experiment and at 10-day intervals after the beginning of the shake intake .\
METHODS	The standard lipid profile ( total cholesterol , triglycerides and HDL cholesterol ) and glycemia , or blood sugar levels , were evaluated by an enzyme colorimetric assay .\
RESULTS	The results of the symbiotic group showed a non-significant reduction ( P > 0.05 ) in total cholesterol and triglycerides , a significant increase ( P < 0.05 ) in HDL cholesterol and a significant reduction ( P < 0.05 ) in fasting glycemia .\
RESULTS	No significant changes were observed in the placebo group .\
CONCLUSIONS	The consumption of symbiotic shake resulted in a significant increase in HDL and a significant decrease of glycemia .\
BACKGROUND	ClinicalTrials.gov : NCT00123456 .\
\
###18037734\
BACKGROUND	It is unclear whether a marked reduction of low-density lipoprotein-cholesterol ( LDL-C ) in patients with coronary heart disease ( CHD ) and mild hypercholesterolemia leads to less progression of atherosclerosis .\
RESULTS	Patients with CHD and hypercholesterolemia ( 100 < LDL-C < 140 mg/dl ) who underwent coronary angiography ( CAG ) and intravascular ultrasound ( IVUS ) were randomly assigned to the atorvastatin ( 10-20 mg/day ) group or ; usual care ' group .\
RESULTS	After 12 months 58 patients had follow-up CAG and IVUS studies that could be evaluated .\
RESULTS	Cross-sectional areas of the vessel , lumen , and plaque were measured at 1-mm intervals , and volumetric calculations were based on Simpson 's rule .\
RESULTS	After 12 months , the mean reduction of LDL-C was 34 % in the atorvastatin group and 0 % in the usual care group ( p < 0.01 ) .\
RESULTS	The mean absolute plaque volume showed a larger increase in the usual care group than in the atorvastatin group ( atorvastatin -1.4 + / -11.6 mm3 , usual care 7.6 + / -10.3 mm3 ; p < 0.01 ) .\
RESULTS	Vessel volume also showed a larger increase in the usual care group than in the atorvastatin group ( atorvastatin 2.2 + / -10.9 mm3 , usual care 10.9 + / -17.7 mm3 ; p = 0.03 ) .\
CONCLUSIONS	Atorvastatin treatment prevented the further progression of atherosclerosis by maintaining LDL-C below 100 mg/dl in patients with CHD and hypercholesterolemia ( 100 < LDL-C < 140 mg/dl ) .\
\
###9824573\
BACKGROUND	Medium chain C8-C10 triglycerides ( MCTs ) improve fat absorption in short bowel patients .\
BACKGROUND	Effects on overall energy absorption remain unknown .\
OBJECTIVE	To determine whether MCTs and medium chain fatty acids ( MCFAs ) are absorbed in the colon like the short chain fatty acids ( SCFAs ) or are lost in faeces similarly to long chain fatty acids ( LCFAs ) .\
METHODS	Nine small bowel resected patients without and 10 with a colon in continuity excreted 2-6 MJ/day and were randomised and crossed over between two high fat diets ( 10 MJ/day , 50 % as fat ) , based on either long chain triglycerides ( LCT ) alone or equal quantities of LCT and MCT .\
RESULTS	Patients with a colon absorbed C8-C10 fatty acids considerably better than patients without a colon at similar and extreme levels of LCFA malabsorption ; the colonic impact on absorption of C14-18 fatty acids was negligible .\
RESULTS	MCT redoubled fat ( MCT+LCT ) absorption from 23 % to 58 % in patients with a colon , and increased overall bomb calorimetric energy absorption from 46 % to 58 % .\
RESULTS	The increase in fat absorption from 37 % to 46 % in patients without a colon did not improve overall energy absorption because malabsorption of carbohydrate and protein increased .\
CONCLUSIONS	In small bowel resected patients , the colon seems to serve as a digestive organ for medium chain fat , probably absorbed as MCFAs , perhaps because like the SCFAs , they are water soluble .\
CONCLUSIONS	Only patients with a colon gained from MCT treatment .\
\
###23415202\
BACKGROUND	In many centers of pediatric care , treatment for complicated appendicitis includes appendectomy followed by the use of parenteral broad spectrum antibiotics by .\
BACKGROUND	The aim of the study is to demonstrate the possibility of use of oral antibiotics during the postoperative period in children with complicated acute appendicitis , after a short administration of intravenous antibiotics .\
METHODS	This study shows the initial results of a controlled clinical trial on the use of postoperative sequential antibiotics ( i.v. and oral ) in children treated for complicated acute appendicitis .\
RESULTS	Between August and November 2009 , 29 children were diagnosed and treated for complicated acute appendicitis in the Department of Pediatric Surgery .\
RESULTS	Of these children , 27 were included in the study .\
RESULTS	Twelve children received sequential postoperative antibiotic therapy ( i.v. and oral ) and 15 were treated according to the conventional scheme .\
RESULTS	The length of hospital stay was 3.61 days in the group children with sequential treatment , whereas in the group treated conventionally the hospital stay was 6.86 days .\
RESULTS	Costs were $ 256.56 USD in the group with sequential treatment with an increase of $ 581.99 USD for the group treated conventionally .\
CONCLUSIONS	Initial results show a shorter hospital stay and lower costs for the group of children with sequential postoperative antimicrobial therapy .\
\
###11725155\
OBJECTIVE	It remains an unsolved issue whether hormone replacement therapy ( HRT ) lowers blood pressure .\
OBJECTIVE	This randomized trial examined the effect of 17beta-oestradiol combined cyclically with gestodene on blood pressure of postmenopausal women who were not on antihypertensive medication .\
OBJECTIVE	All subjects had an increased risk for adverse vascular events as indicated by intima-media thickness of carotid arteries and standard risk factors .\
METHODS	Two hundred and twenty-six postmenopausal women were randomized to oral treatment for 48 weeks with 1 mg of 17beta-oestradiol per day continuously , plus 0.025 mg gestodene on days 17-28 of each 4-week cycle ( HRT 1 ) , or plus gestodene in each third cycle only ( HRT 2 ) , or no HRT .\
METHODS	According to predefined criteria , four subjects in HRT 1 , 12 in HRT 2 and 13 in no HRT who were started on antihypertensive medication were excluded from the analysis .\
METHODS	Thirty subjects ended participation prematurely for other reasons .\
METHODS	Resting blood pressure was measured at baseline and after 12 , 22 and 48 weeks .\
RESULTS	During treatment diastolic blood pressure changed significantly in both HRT groups compared to no HRT , by -3.7 + / - 9.8 mmHg , -3.0 + / - 8.8 mmHg and 1.0 + / - 9.9 mmHg at week 48 in groups HRT 2 , HRT 1 and no HRT , respectively ( P = 0.008 for HRT 2 versus no HRT , P = 0.027 for HRT 1 versus no HRT ) .\
RESULTS	The higher the diastolic blood pressure was at beginning the greater was the decrease .\
RESULTS	The decrease of systolic blood pressure was not significantly different between groups .\
CONCLUSIONS	For postmenopausal women with high cardiovascular risk but without antihypertensive medication , long-term treatment with 17beta-oestradiol combined with gestodene lowers diastolic blood pressure .\
\
###24874564\
BACKGROUND	Wholegrain rye has been associated with decreased hunger sensations .\
BACKGROUND	This may be partly mediated by colonic fermentation .\
BACKGROUND	Sustained consumption of fermentable components is known to change the gut microflora and may increase numbers of saccharolytic bacteria .\
OBJECTIVE	To investigate the effect of wholegrain rye consumption on appetite and colonic fermentation after a subsequent meal .\
METHODS	In a randomized , controlled , three-arm cross-over study , twelve healthy male subjects consumed three iso-caloric evening test meals .\
METHODS	The test meals were based on white wheat bread ( WBB ) , wholegrain rye kernel bread ( RKB ) , or boiled rye kernels ( RK ) .\
METHODS	Breath hydrogen excretion and subjective appetite sensation were measured before and at 30min intervals for 3h after a standardized breakfast in the subsequent morning .\
METHODS	After the 3h , an ad libitum lunch meal was served to assess energy intake .\
METHODS	In an in vitro study , RKB and RK were subjected to digestion and 24h-fermentation in order to study SCFA production and growth of selected saccharolytic bacteria .\
RESULTS	The test meals did not differ in their effect on parameters of subjective appetite sensation the following day .\
RESULTS	Ad libitum energy intake at lunch was , however , reduced by 11 % ( P < 0.01 ) after RKB and 7 % ( P < 0.05 ) after RK compared with after WWB evening meal .\
RESULTS	Breath hydrogen excretion was significantly increased following RKB and RK evening meals compared with WWB ( P < 0.01 and P < 0.05 , respectively ) .\
RESULTS	Overall , RKB and RK were readily fermented in vitro and exhibited similar fermentation profiles , although total SCFA production was higher for RK compared with RKB ( P < 0.001 ) .\
RESULTS	In vitro fermentation of RKB and RK both increased the relative quantities of Bifidobacterium and decreased Bacteroides compared with inoculum ( P < 0.001 ) .\
RESULTS	The C. coccoides group was reduced after RKB ( P < 0.001 ) .\
CONCLUSIONS	Consumption of wholegrain rye products reduced subsequent ad libitum energy intake in young healthy men , possibly mediated by mechanisms related to colonic fermentation .\
\
###15249439\
OBJECTIVE	Auto-continuous positive airway pressure ( CPAP ) has been reported to have no more efficacy than constant CPAP in unselected patients with sleep apnea hypopnea syndrome ( SAHS ) .\
OBJECTIVE	The aim of this study was to evaluate patients judged to be good candidates for auto-CPAP because of a high within-night variability in pressure requirement .\
METHODS	Single-blind , randomized , cross-over study ( 2 x 8 weeks ) to compare auto-CPAP with constant CPAP .\
METHODS	Outpatients with moderate-to-severe SAHS attending the chest clinic .\
METHODS	Patients were equipped at home in the auto-CPAP mode ( model GK418A ; Malinckrodt ; Nancy , France ) , using a 4 - to 14-cm H ( 2 ) O pressure range .\
METHODS	Those individuals having a high within-night variability in pressure requirement , assessed at the end of a 14-day run-in period , were included in the cross-over study .\
METHODS	Auto-CPAP was compared with constant CPAP ( according to a titration night in the sleep laboratory ) in terms of compliance , efficacy on apneas ( assessed from the pressure monitor ) , and sleepiness ( assessed on the Epworth sleepiness scale ) .\
RESULTS	Of 90 consecutive patients with SAHS , 27 patients were selected for a within-night variability in pressure requirement exceeding a given threshold .\
RESULTS	After completion of the cross-over , 24 patients were evaluable .\
RESULTS	The median percentage of nights the machine was used was 95.5 % ( range , 45 to 100 % ) on constant CPAP , and 96.5 % ( range , 40 to 100 % ) on auto-CPAP ; the median apnea index recorded by the device was 0.40 / h ( range , 0 to 2.40 / h ) on constant CPAP , and 0.45 / h ( range , 0 to 5.80 / h ) on auto-CPAP ( differences not significant ) .\
RESULTS	The mean Epworth sleepiness score was significantly ( p < 0.01 ) lower on auto-CPAP ( 5.1 ; SD , 2.8 ) than on constant CPAP ( 6.1 ; SD , 2.8 ) .\
CONCLUSIONS	In patients selected for a high within-night variability in pressure requirement , auto-CPAP administered via a GK418A device was equivalent to constant CPAP based on a titration night in the sleep laboratory .\
CONCLUSIONS	Subjective ratings for sleepiness were slightly lower on auto-CPAP .\
\
###15277423\
OBJECTIVE	To assess the prevalence and clinical predictors of silent myocardial ischemia in asymptomatic patients with type 2 diabetes and to test the effectiveness of current American Diabetes Association screening guidelines .\
METHODS	In the Detection of Ischemia in Asymptomatic Diabetics ( DIAD ) study , 1,123 patients with type 2 diabetes , aged 50-75 years , with no known or suspected coronary artery disease , were randomly assigned to either stress testing and 5-year clinical follow-up or to follow-up only .\
METHODS	The prevalence of ischemia in 522 patients randomized to stress testing was assessed by adenosine technetium-99m sestamibi single-photon emission-computed tomography myocardial perfusion imaging .\
RESULTS	A total of 113 patients ( 22 % ) had silent ischemia , including 83 with regional myocardial perfusion abnormalities and 30 with normal perfusion but other abnormalities ( i.e. , adenosine-induced ST-segment depression , ventricular dilation , or rest ventricular dysfunction ) .\
RESULTS	Moderate or large perfusion defects were present in 33 patients .\
RESULTS	The strongest predictors for abnormal tests were abnormal Valsalva ( odds ratio [ OR ] 5.6 ) , male sex ( 2.5 ) , and diabetes duration ( 5.2 ) .\
RESULTS	Other traditional cardiac risk factors or inflammatory and prothrombotic markers were not predictive .\
RESULTS	Ischemic adenosine-induced ST-segment depression with normal perfusion ( n = 21 ) was associated with women ( OR 3.4 ) .\
RESULTS	Selecting only patients who met American Diabetes Association guidelines would have failed to identify 41 % of patients with silent ischemia .\
CONCLUSIONS	Silent myocardial ischemia occurs in greater than one in five asymptomatic patients with type 2 diabetes .\
CONCLUSIONS	Traditional and emerging cardiac risk factors were not associated with abnormal stress tests , although cardiac autonomic dysfunction was a strong predictor of ischemia .\
\
###16216596\
BACKGROUND	Oxidation of LDL ( oxLDL ) is thought to have an important role in early stages of atherogenesis .\
BACKGROUND	Antibody to oxLDL ( Ab-oxLDL ) has been proposed as a biomarker which might be directly associated with oxidative stress .\
BACKGROUND	Yet studies designed to test this hypothesis are lacking .\
BACKGROUND	We tested the hypothesis that consumption of a healthy diet rich in fruits and vegetables and reduced in saturated fat , total fat , and cholesterol will concomitantly reduce oxidative stress and Ab-oxLDL .\
METHODS	One hundred and three healthy individuals were randomly assigned to consume a typical American ( control ) diet or the DASH diet rich in fruits , vegetables and low-fat dairy products and reduced in fat ( 27 % ) , saturated fat ( 7 % ) , and cholesterol ( 150 mg/day ) for 3 months .\
METHODS	Outcomes were urinary isoprostanes ( in vivo marker of oxidative stress ) , oxygen radical absorbing capacity ( ORAC , an in vitro assay measuring antioxidant activity in serum ) , and Ab-oxLDL measured at baseline , 1-3 months of feeding .\
RESULTS	Compared to the control diet , consumption of the DASH diet significantly lowered urinary isoprostane ( -226 pg/ml , 95 % CI : -420 to -32 , P = 0.023 ) .\
RESULTS	Compared with the control group , change in ORAC was higher in the DASH group , 143 trolox units/ml ( 95 % CI : -23 to 308 , P = 0.091 ) .\
RESULTS	In comparison with the control diet , increased titers of Ab-oxLDL ( 37 mU/ml [ 95 % CI : 16-57 , P = 0.006 ] ) were seen after consumption of the DASH diet .\
RESULTS	Higher titers of Ab-oxLDL occurred at month 2 ( 56 mU/ml , 95 % CI : 20-90 , P = 0.004 ) and month 3 ( 41 mU/ml , 95 % CI : -6 to 88 , P = 0.082 ) , after initially small increases at month 1 ( 20 mU/ml , 95 % CI : -10 to 51 , P = 0.176 ) .\
RESULTS	End-of-study increases in AB-oxLDL were highly correlated with increased ORAC ( Spearman 's rho = 0.46 , P < 0.0001 ) , but not with changes in specific carotenoids , tocopherols or with change in LDL cholesterol ( each : P > 0.10 ) .\
CONCLUSIONS	Consumption of a healthy diet replete in antioxidants reduced oxidative stress ( urinary isoprostanes ) yet increased Ab-oxLDL .\
CONCLUSIONS	This indirect association of Ab-oxLDL with urinary isoprostanes hinders use of Ab-oxLDL as a marker of oxidative damage .\
\
###17211855\
BACKGROUND	Postprandial metabolism is impaired in patients with type 2 diabetes ( T2Dm ) .\
BACKGROUND	Two thiazolidinediones pioglitazone ( PGZ ) and rosiglitazone ( RGZ ) have similar effects on glycaemic control but differ in their effects on fasting lipids .\
BACKGROUND	This study investigated the effects of RGZ and PGZ on postprandial metabolism in a prospective , randomized crossover trial .\
METHODS	Seventeen patients with T2Dm were randomized to RGZ or PGZ for 12 weeks , with an 8-week wash-out period .\
METHODS	Fasting blood samples were taken for glucose ( FPG ) , insulin , HbA ( 1c ) , lipids , apolipoproteins ( apo ) , lipoprotein ( LPL ) and hepatic lipase ( HL ) , and cholesterol ester transfer protein ( CETP ) activity .\
METHODS	A standardized breakfast was served and postprandial glucose , insulin , and lipid subfraction profiles were determined .\
RESULTS	RGZ and PGZ treatment resulted in a similar improvement in FPG , HbA ( 1c ) and homeostasis model assessment .\
RESULTS	Fasting and postprandial triglyceride ( TG ) levels were significantly lower following PGZ therapy ( fasting : -0.35 vs 0.44 mmol/L ; p < 0.04 ; postprandial AUC-TG : -195.6 vs 127.9 mmol/L/min ; p < 0.02 ) associated with changes in VLDL-2-TG ( -0.10 vs 0.21 mmol/L ; p = 0.23 ) and VLDL-3-TG ( 0.0 vs 0.34 mmol/L ; p < 0.04 ) .\
RESULTS	Fasting cholesterol increased with RGZ compared to PGZ ( 0.06 vs 0.59 mmol/L ; p < 0.04 ) , particularly in VLDL-2-C ( -0.30 vs 0.59 mmol/L ; p < 0.03 ) and VLDL-3-C ( -0.85 vs 2.11 mmol/L ; p < 0.02 ) .\
RESULTS	Postprandial VLDL lipid and protein content increased after RGZ and decreased after PGZ .\
RESULTS	Fasting apoB , apoA-I , apoC-II/C-III-ratio , and LPL activity did not differ .\
RESULTS	CETP activity decreased after RGZ and increased after PGZ ( -6.2 vs 4.2 p/mol/mL / min ; p < 0.002 ) .\
CONCLUSIONS	Both the glitazones had similar effects on glucose metabolism .\
CONCLUSIONS	The additional beneficial effect of PGZ on lipid metabolism may be related to its effects on insulin-independent VLDL production and CETP activity .\
\
###7645637\
OBJECTIVE	Our purpose was to determine whether in a low-dose aspirin trial a longitudinal decrease in maternal serum thromboxane B2 is associated with improvement in pregnancy outcomes .\
METHODS	A total of 606 healthy nulliparous women with singleton gestations were randomized at 24 weeks to either 60 mg of aspirin or a placebo .\
METHODS	Maternal serum thromboxane B2 was measured at randomization , at 29 to 31 weeks , at 34 to 36 weeks , and at delivery .\
METHODS	After delivery , and without knowledge of patient outcome or group assignment , patients were categorized as having had either a longitudinal twofold or greater ( > or = 50 % ) or less than twofold reduction ( < 50 % ) in thromboxane B2 from baseline levels at randomization .\
RESULTS	Of 606 entrants , 92 % had sufficient thromboxane B2 determinations to allow categorization .\
RESULTS	Whether patients were assigned to aspirin or placebo , birth weight was significantly greater in women who had a twofold or greater reduction in maternal serum thromboxane B2 levels .\
RESULTS	When the aspirin and placebo groups were combined , women with a twofold or greater reduction in thromboxane B2 levels had less preeclampsia , 1.9 % ( 6/314 ) versus 5.7 % ( 14/244 ) ( p = 0.016 ) , less preterm delivery ( 5.7 % vs 10.7 % , p = 0.032 ) , fewer small-for-gestational-age newborns , 9 of 314 ( 2.95 ) versus 17 of 244 ( 7 % ) ( p = 0.023 ) , and a higher mean birth weight , 3314 gm versus 3121 gm ( p = 0.0001 ) .\
CONCLUSIONS	Women with a twofold or greater longitudinal reduction in maternal serum thromboxane B2 had less preeclampsia and prematurity , fewer small-for-gestational-age newborns , and higher birth weights than women with less than a twofold reduction .\
\
###24519331\
OBJECTIVE	To determine whether mental practice of wrist movements during forearm immobilization maintains range of motion .\
METHODS	Randomized controlled trial .\
METHODS	Eighteen healthy young men aged between 20 and 30 years were assigned to either a control or a mental practice group .\
METHODS	Both groups were immobilized with a circular forearm cast for 3 weeks to simulate a distal radial fracture .\
METHODS	The mental practice group received 1 60-min , followed by 3 30-min , sessions of supervised mental practice .\
METHODS	Consecutively , they were asked to perform 15 min/day of self-guided imagery sessions , during which they mentally exercised motion sequences of the immobilized joint .\
METHODS	The training program followed the Mental Gait Training procedure .\
METHODS	The control group did no training .\
METHODS	Wrist movement was measured with a goniometer before and after immobilization .\
RESULTS	Mental practice preserved dorsal extension and ulnar abduction .\
RESULTS	The sedentary control group showed due to this variables a significant decrease after cast removal .\
RESULTS	There was no significant change in palmar flexion and radial abduction in either group .\
CONCLUSIONS	Despite the study limitations , these results suggest that mental practice may be useful in preventing loss of hand function associated with mid-term immobilization .\
CONCLUSIONS	Because of the expected clinical benefits , the low cost and simple application of the intervention , the effects of mental practice in orthopedic rehabilitation of the upper extremity warrant further study .\
\
###19561174\
BACKGROUND	Female athletes have a higher risk of anterior cruciate ligament injury than their male counterparts who play at similar levels in sports involving pivoting and landing .\
OBJECTIVE	The competitive female basketball players who participated in a sports injury prevention training program would show better muscle strength and flexibility and improved biomechanical properties associated with anterior cruciate ligament injury than during the pretraining period and than posttraining parameters in a control group .\
METHODS	Controlled laboratory study .\
METHODS	A total of 22 high school female basketball players were recruited and randomly divided into 2 groups ( the experimental group and the control group , 11 participants each ) .\
METHODS	The experimental group was instructed in the 6 parts of the sports injury prevention training program and performed it during the first 20 minutes of team practice for the next 8 weeks , while the control group performed their regular training program .\
METHODS	Both groups were tested with a rebound-jump task before and after the 8-week period .\
METHODS	A total of 21 reflective markers were placed in preassigned positions .\
METHODS	In this controlled laboratory study , a 2-way analysis of variance ( 2 x 2 ) experimental design was used for the statistical analysis ( P < .05 ) using the experimental group and a testing session as within and between factors , respectively .\
METHODS	Post hoc tests with Sidak correction were used when significant factor effects and/or interactions were observed .\
RESULTS	A comparison of the experimental group 's pretraining and posttraining results identified training effects on all strength parameters ( P = .004 to .043 ) and on knee flexion , which reflects increased flexibility ( P = .022 ) .\
RESULTS	The experimental group showed higher knee flexion angles ( P = .024 ) , greater interknee distances ( P = .004 ) , lower hamstring-quadriceps ratios ( P = .023 ) , and lower maximum knee extension torques ( P = .043 ) after training .\
RESULTS	In the control group , no statistical differences were observed between pretraining and posttraining findings ( P = .084 to .873 ) .\
RESULTS	At pretraining , no significant differences were observed between the 2 groups for any parameter ( P = .067 to .784 ) .\
RESULTS	However , a comparison of the 2 groups after training revealed that the experimental group had significantly higher knee flexion angles ( P = .023 ) , greater knee distances ( P = .005 ) , lower hamstring-quadriceps ratios ( P = .021 ) , lower maximum knee extension torques ( P = .124 ) , and higher maximum knee abduction torques P ( = .043 ) than the control group .\
CONCLUSIONS	The sports injury prevention training program improved the strength and flexibility of the competitive female basketball players tested and biomechanical properties associated with anterior cruciate ligament injury as compared with pretraining parameters and with posttraining parameters in the control group .\
CONCLUSIONS	This injury prevention program could potentially modify the flexibility , strength , and biomechanical properties associated with ACL injury and lower the athlete 's risk for injury .\
\
###20578781\
BACKGROUND	Several treatment options are available for patients with type 2 diabetes mellitus who are making the transition from oral antidiabetes drugs ( OADs ) to insulin .\
BACKGROUND	Two options currently recommended by the Canadian Diabetes Association for initiating insulin therapy in patients with type 2 diabetes who are no longer responsive to OADs alone are insulin glargine plus OADs , and premixed insulin therapy only .\
BACKGROUND	Because of differences in efficacy , adverse events ( such as hypoglycaemia ) and acquisition costs , these two treatment options may lead to different long-term clinical and economic outcomes .\
OBJECTIVE	To determine the cost effectiveness of insulin glargine plus OADs compared with premixed insulin without OADs in insulin-naive patients with type 2 diabetes in Canada .\
METHODS	Using treatment effects taken from a published clinical trial , the validated IMS-CORE Diabetes Model was used to simulate the long-term cost effectiveness of insulin glargine with OADs , versus premixed insulin .\
METHODS	Input treatment effects for the two therapeutic approaches were based on changes in glycosylated haemoglobin A ( 1c ) ( HbA ( 1c ) ) at clinical trial endpoint , and hypoglycaemia rates .\
METHODS	The analysis was conducted from the perspective of the Canadian Provincial payer .\
METHODS	Direct treatment and complication costs were obtained from published sources ( primarily from Ontario ) and reported in $ Can , year 2008 values .\
METHODS	All base-case costs and outcomes were discounted at 5 % per year .\
METHODS	Sensitivity analyses were conducted around key parameters and assumptions used in the study .\
METHODS	Outcomes included direct medical costs associated with both treatment and diabetes-related complications .\
METHODS	Cost-effectiveness outcomes included total average lifetime ( 35 years ) costs , life expectancy ( LE ) , QALYs and incremental cost-effectiveness ratios ( ICERs ) .\
RESULTS	Base-case analyses showed that , compared with premixed insulin only , insulin glargine in combination with OADs was associated with a 0.051-year increase in LE and a 0.043 increase in QALYs .\
RESULTS	Insulin glargine plus OADs showed a very slight increase in total direct costs ( $ Can 343 + / - 2572 ) , resulting in ICERs of $ Can 6750 per life-year gained ( LYG ) and $ Can 7923 per QALY gained .\
RESULTS	However , considerable uncertainty around the ICERs was demonstrated by insulin glargine having a 50 % probability of being cost effective at a willingness-to-pay threshold of $ Can 10,000 per QALY , and a 54 % probability at a $ Can 20,000 threshold .\
RESULTS	Base-case results were most sensitive to assumed disutilities for hypoglycaemic events , to the assumed effect of insulin glargine plus OADs on HbA ( 1c ) , and to its assumed acquisition costs .\
CONCLUSIONS	These findings should be interpreted within the context of a large degree of uncertainty and of several study limitations that include a single clinical trial as the source for primary treatment assumptions and a single province as the source for most cost inputs .\
CONCLUSIONS	Under current study assumptions and limitations , insulin glargine plus OADs was projected to be a cost-effective option , compared with premixed insulin only , for the treatment of insulin-naive patients with type 2 diabetes unresponsive to OADs .\
CONCLUSIONS	Additional work is needed to examine the generalizability of the findings to individual jurisdictions of the Canadian healthcare system .\
\
###10353071\
OBJECTIVE	To evaluate and compare the influences of micronized fenofibrate and atorvastatin on serum lipid profile , including lipoprotein ( a ) levels , and on fibrinogen levels in a large group of patients with primary mixed hyperlipidemia ( serum total and low-density lipoprotein cholesterol levels > 240 and 160 mg/dl , respectively , and serum triglyceride level > 200 mg/dl ) .\
METHODS	This was a 16-week , open-label , parallel-design study conducted in our lipid clinic .\
METHODS	After a 6-week dietary baseline phase , we implemented a treatment phase , during which patients received 10 mg/day atorvastatin ( n = 45 ) or 200 mg/day micronized fenofibrate ( n = 46 ) for 16 weeks .\
METHODS	Patients were assigned to one of the drugs in sequential orders .\
METHODS	Serum lipid profiles , including levels of lipoprotein ( a ) and fibrinogen , as well as muscle and liver enzymes , were measured during screening , and during weeks -4 , -2 , 0 , 8 , and 16 of the treatment period .\
RESULTS	Atorvastatin was more effective than was micronized fenofibrate at lowering levels of total and low-density lipoprotein cholesterol , whereas fenofibrate was more effective at lowering levels of triglycerides , and raising levels of high-density lipoprotein cholesterol and apolipoprotein A1 .\
RESULTS	However , micronized fenofibrate could significantly decrease plasma fibrinogen levels , whereas atorvastatin evoked a small increase .\
CONCLUSIONS	Both atorvastatin in small doses and micronized fenofibrate are effective for improving serum lipid profiles of patients with mixed hyperlipidemia .\
CONCLUSIONS	However , there are considerable differences between the two drugs concerning their influences on plasma fibrinogen levels .\
\
###15790985\
BACKGROUND	Combined treatment with inhaled corticosteroids and long acting beta2 agonists is approved for the treatment of chronic obstructive pulmonary disease ( COPD ) , but little is known about the onset of effect of the combination .\
METHODS	Data were used from 1465 patients with COPD entered into a large 1 year double blind trial with daily measurements of peak expiratory flow ( PEF ) and symptom scores .\
RESULTS	PEF was significantly higher after 1 day in patients treated with salmeterol 50 microg twice daily or the salmeterol/fluticasone propionate combination 50/500 microg twice daily than placebo .\
RESULTS	In patients treated with fluticasone propionate 500 microg twice daily alone , PEF differed from placebo after 2 days .\
RESULTS	The differences after 2 weeks compared with placebo were 16 l/min ( 95 % confidence interval ( CI ) 11 to 21 ) , 11 l/min ( 95 % CI 6 to 16 ) , and 27 l/min ( 95 % CI 22 to 33 ) for salmeterol , fluticasone propionate , and the salmeterol/fluticasone propionate combination , respectively .\
RESULTS	For all treatments the effect on PEF after 2 weeks was comparable to that seen at the end of the study .\
RESULTS	The difference between the salmeterol/fluticasone propionate combination and placebo after 2 weeks as a percentage of baseline was similar for PEF and clinic forced expiratory volume in 1 second ( FEV1 ) .\
RESULTS	Differences in breathlessness scores were statistically significant after 1 day for the group treated with salmeterol alone and after 2 days for the combination group .\
RESULTS	The 2 week change in FEV1 was only partly indicative of a long term response in individual patients .\
CONCLUSIONS	The effects of salmeterol and fluticasone propionate , alone or in combination , on PEF and breathlessness are seen within days and most of the obtainable effect on these parameters is reached within 2 weeks .\
\
###9614778\
BACKGROUND	Autonomic dysfunction plays an important role in the pathogenesis , treatment and prognosis of congestive heart failure ( CHF ) .\
BACKGROUND	Sympathomimetic amines have been widely used in the treatment of CHF , but reports on their autonomic effects in CHF are rare .\
BACKGROUND	This study was designed to evaluate the effects of dopamine and dobutamine on cardiac autonomic function as assessed by heart rate variability ( HRV ) .\
METHODS	Twenty patients with symptomatic CHF ( systolic dysfunction ) were enrolled .\
METHODS	After recording one-hour baseline electrocardiographs ( ECGs ) , patients were randomly selected for either dopamine ( 4 micrograms/kg/minute , Group A ) or dobutamine ( 4 micrograms/kg/minute , Group B ) treatment for three days .\
METHODS	On the third day , a 24-hour ambulatory ECG was recorded and a tilt-table test was performed .\
METHODS	Only furosemide and nitrates were allowed for adjunctive therapy .\
METHODS	HRV was measured before and after treatment in both time and frequency domains .\
METHODS	Frequency-domain HRV was also measured during head-up tilt .\
RESULTS	After treatment , all patients improved [ New York Heart Association fraction ( NYHA Fc ) 3.7 to 2.0 ] .\
RESULTS	Group A patients had higher post-treatment 24-hour HRV than those in Group B. SDNN ( standard deviation of the average normal RR intervals in the entire ECG recording ) , SDANN ( standard deviation of the average normal RR intervals for all five minute segments of an entire ECG recording ) and SDNN indices in Group A were significantly higher than in Group B ( 90 + / - 33 ms vs 41 + / - 12 ms , 78 + / - 32 ms vs 36 + / - 11 ms , and 37 + / - 19 ms vs 16 + / - 7 ms , respectively , all p < 0.05 ) .\
RESULTS	rMSSD ( the square root of the mean of the squared differences between adjacent normal RR intervals over the entire ECG recording ) and pNN50 ( percentage of differences between adjacent normal RR intervals that are greater than 50 ms computed over the entire ECG recording ) were also higher in Group A patients , with borderline significance .\
RESULTS	All measurements of total frequency and low-frequency and high-frequency components tended to be higher in Group A than Group B , but this was only significant for total frequency amplitude ( 22.9 + / - 13.4 ms vs 10.9 + / - 6.1 ms , p < 0.05 ) .\
RESULTS	Dopamine but not dobutamine treatment seems to restore the depressed circadian change in frequency-domain HRV classically seen in patients with CHF .\
RESULTS	The HRV change during head-up tilting did not differ between the two groups .\
RESULTS	Three patients in Group B showed non-sustained ventricular tachycardia on ambulatory ECG during the treatment period .\
CONCLUSIONS	Dopamine and dobutamine have comparable therapeutic effects in patients with CHF , but low-dose dopamine more favorably affects cardiac autonomic function .\
\
###17550366\
BACKGROUND	Alcohol screening , brief intervention , and referral to specialized treatment ( ASBIR ) reduce drinking and related harms .\
BACKGROUND	Unanswered questions are how to manage nondependent patients with poor response to brief interventions , how to manage dependent patients who do not obtain treatment , and how to ensure population-wide delivery of ASBIR .\
BACKGROUND	Telephone-administered counseling may provide answers .\
METHODS	We conducted a 12-month randomized controlled trial of a telephone and mail intervention for non-treatment-seeking primary care patients with alcohol use disorders .\
METHODS	We enrolled 897 subjects after systematic screening in 18 primary care clinic waiting rooms in and around Madison and Milwaukee , Wisconsin , and subsequent telephone-administered diagnostic interviews .\
METHODS	Experimental subjects received up to six sessions of protocol-driven telephone counseling based on principles of motivational interviewing and stages of readiness to change .\
METHODS	Control subjects received a pamphlet on healthy lifestyles .\
METHODS	The paper reports on 3-month drinking outcomes for men and women with alcohol abuse and dependence .\
RESULTS	Male experimental subjects ( N = 199 ) manifested a 30.6 % decline in risky drinking days , compared with a 8.3 % decline in controls ( N = 201 , p < 0.001 ) .\
RESULTS	The total consumption declined by 17.3 % compared with 12.9 % by controls ( p = 0.001 ) .\
RESULTS	Female experimental subjects ( N = 246 ) manifested a 17.2 % decrease in risky drinking days compared with an 11.5 % decrease by controls ( N = 251 ; p = NS ) and a 13.9 % decline in total consumption compared with 11.0 % by controls ( p = NS ) .\
RESULTS	Greater numbers of telephone counseling sessions were associated with greater declines in drinking .\
CONCLUSIONS	Following systematic screening , a six-session telephone and mail intervention is more effective than a pamphlet in reducing drinking at 3 months for non-treatment-seeking men with alcohol abuse and dependence .\
CONCLUSIONS	An intervention effect of the enrollment procedures may have obscured further intervention effectiveness .\
CONCLUSIONS	Telephone counseling shows promise for non-treatment-seeking primary care patients with alcohol use disorders .\
\
###17676201\
OBJECTIVE	Midazolam , propofol and fentanyl were compared in terms of sedation during cataract extraction .\
OBJECTIVE	Hemodynamic parameters , sedation level , postoperative satisfaction , and side effects were investigated .\
METHODS	The study was carried out in Hacettepe University Hospitals Ophthalmology Operating Theatres in 2005 .\
METHODS	The patients received only midazolam ( 0.02 mg kg-1 ) , or midazolam ( 0.02 mg kg-1 ) + propofol ( 0.2 mg kg-1 ) , or midazolam ( 0.02 mg kg-1 ) + fentanyl ( 1 microgram kg-1 ) , or midazolam ( 0.02 mg kg-1 ) + propofol ( 0.2 mg kg-1 ) + fentanyl ( 1 microgram kg-1 ) .\
METHODS	The sedation level of patients was measured according to a physician questionnaire .\
METHODS	Postoperative nausea/vomiting , headache , and patient satisfaction were determined via a patient 's evaluation scale .\
RESULTS	In the groups receiving fentanyl , the hemodynamic response to peribulbar block insertion was minimal ( p < 0.05 ) and the sedation level was best ( p < 0.05 ) .\
RESULTS	Respiration rate and O2 saturation of patients receiving midazolam , propofol , and fentanyl decreased after sedation ( p < 0.01 ) and postoperative satisfaction was high in this group ( p < 0.01 ) .\
RESULTS	Patients in the midazolam group showed a prominent reaction to peribulbar block insertion while movement during the operation was obvious ( p < 0.05 ) .\
CONCLUSIONS	The combination of midazolam , propofol , and fentanyl should be preferred to other study groups as the sedation level is suitable for cataract extraction with high postoperative patient satisfaction and without any side effects .\
\
###15119980\
OBJECTIVE	To demonstrate the equivalent efficacy of temazepam 7.5 mg and temazepam 15 mg for the treatment of transient insomnia .\
METHODS	This was a double-blind , parallel group , multicenter study .\
METHODS	Healthy male and female subjects with previous but not current complaints of transient insomnia were enrolled .\
METHODS	Transient insomnia was induced in the sleep laboratory by means of the ` first night ' effect and by implementing a 2-h phase advance .\
METHODS	The effects of both doses of temazepam on polysomnographic ( PSG ) measures of sleep were evaluated for one night .\
METHODS	Latency to persistent sleep ( LPS ) and total sleep time ( TST ) were designated as the primary efficacy endpoints .\
RESULTS	One hundred and thirty-one subjects completed the study : 65 received the 7.5-mg dose , and 66 received the 15-mg dose .\
RESULTS	Treatment groups begin with the lowest effective dose , i.e. , 7.5 mg .\
RESULTS	were well matched based on background demographics .\
RESULTS	No statistically significant differences between doses were detected for LPS , TST , or any other objective ( PSG ) measure of sleep .\
RESULTS	Furthermore , both doses were found to be clinically equivalent for LPS and TST based on predetermined criteria .\
RESULTS	Temazepam was well tolerated , and no significant differences between doses were found for adverse event ( AE ) incidence , mean score on the Digit Symbol Substitution Task , or mean scores on questions related to tolerability from the Leeds Sleep Evaluation Questionnaire .\
CONCLUSIONS	The 7.5-mg and 15-mg doses of temazepam were equally effective for the treatment of transient insomnia .\
CONCLUSIONS	In keeping with current practice guidelines , initiation of treatment with temazepam for transient insomnia should\
\
###11748389\
BACKGROUND	Adaptive support ventilation ( ASV ) is a microprocessor-controlled mode of mechanical ventilation that maintains a predefined minute ventilation with an optimal breathing pattern ( tidal volume and rate ) by automatically adapting inspiratory pressure and ventilator rate to changes in the patient 's condition .\
BACKGROUND	The aim of the current study was to test the hypothesis that a protocol of respiratory weaning based on ASV could reduce the duration of tracheal intubation after uncomplicated cardiac surgery ( `` fast-track '' surgery ) .\
METHODS	A group of patients being given ASV ( group ASV ) was compared with a control group ( group control ) in a randomized controlled study .\
METHODS	After coronary artery bypass grafting during general anesthesia with midazolam and fentanyl , patients were randomly assigned to group ASV or group control .\
METHODS	Both protocols were divided into three predefined phases , and weaning progressed according to arterial blood gas and clinical criteria .\
METHODS	In phase 1 , ASV mode was set at 100 % of the theoretical value of volume/minute in group ASV , and synchronized intermittent mandatory ventilation mode was used in group control .\
METHODS	When spontaneous breathing occurred , ASV setting was reduced by 50 % of minute ventilation ( phase 2 ) and again by 50 % ( phase 3 ) , and the trachea was extubated .\
METHODS	In group control , the ventilator was switched to 10 cm H2O inspiratory pressure support ( phase 2 ) , then to 5 cm H2O ( phase 3 ) until extubation .\
RESULTS	Forty-nine patients were enrolled .\
RESULTS	Sixteen patients completed the ASV protocol , and 20 the standard protocol ; 7 patients were excluded in group ASV and 6 in group control according to explicit , predefined criteria .\
RESULTS	There were no differences between groups in perioperative characteristics or in the doses of sedation .\
RESULTS	The primary outcome of the study , that is , the duration of tracheal intubation , was shorter in group ASV than in group control ( median [ quartiles ] : 3.2 [ 2.5-4 .6 ] vs. 4.1 [ 3.1-8 .6 ] h ; P < 0.02 ) .\
RESULTS	Fewer arterial blood analyses were performed in group ASV ( median number [ quartiles ] : 3 [ 3-4 ] vs. 4 [ 3-6 ] ) , suggesting that fewer changes in the settings of the ventilator were required in this group .\
CONCLUSIONS	A respiratory weaning protocol based on ASV is practicable ; it may accelerate tracheal extubation and simplify ventilatory management in fast-track patients after cardiac surgery .\
CONCLUSIONS	The evaluation of potential advantages of the use of such technology on patient outcome and resource utilization deserves further studies .\
\
###10583422\
BACKGROUND	A number of animal studies and our own clinical trials point towards a possible influence of the renin-angiotensin-system ( RAS ) on erythropoietin ( EPO ) production .\
BACKGROUND	In this study we investigated the role of angiotensin II in the regulation of EPO production in humans .\
METHODS	After a hemorrhage of 750 ml as a basic physiological stimulus 72 healthy male volunteers received in a parallel design either placebo ( physiologic electrolyte solution ) for 6 h , angiotensin II i.v. for 6 h ( 1-3 microgram min-1 , sufficient to increase systolic blood pressure by 20 mmHg ) , the selective AT1-receptor antagonist losartan , the ACE-inhibitor captopril , angiotensin II + losartan , or angiotensin II + captopril .\
RESULTS	Administration of angiotensin II alone and in combination with captopril resulted in a significantly higher Cmax EPO ( 67 % higher vs. placebo , P < 0.05 ) and AUCEPO ( 0-24h ) ( 40 % higher vs. placebo , P < 0.05 ) .\
RESULTS	In the groups receiving losartan or captopril alone or the combination of angiotensin II + losartan no significant difference of Cmax EPO and AUCEPO ( 0-24h ) compared to placebo could be detected .\
CONCLUSIONS	This study shows in a model of controlled , basic physiological stimulation of renal EPO production that angiotensin II is able to increase EPO levels in humans .\
CONCLUSIONS	This effect of angiotensin II can be blocked by the specific AT1-receptor antagonist losartan but not by the ACE-inhibitor captopril .\
CONCLUSIONS	The result may be interpreted as a hint that one signal for the control of EPO production in humans may be mediated by angiotensin II ( AT1 ) - receptors .\
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###8761775\
BACKGROUND	Adapalene is a new chemical entity with retinoid activity .\
METHODS	0.1 p. 100 adapalene gel ( Diffrine gel ) , 0.03 p. 100 adapalene gel and a commercially available 0.025 p. 100 tretinoin gel ( Aberel gel ) were compared in 89 male and female patients with acne .\
RESULTS	Inflammatory , non inflammatory , total lesion counts , and the global facial acne grade regularly decreased as a function of time in the three treatment groups .\
RESULTS	No statistically or clinicaly significant differences were observed for these parameters between 0.1 p. 100 adapalene gel and 0.025 p. 100 tretinoin gel following a 12-week treatment .\
RESULTS	Conversely , both of these gels were significantly more effective than 0.03 p. 100 adapalene gel with regards to inflammatory and total lesion counts , and the global facial acne grade .\
RESULTS	The differences of efficacy seen between both adapalene gels demonstrate a dose-dependent activity of the drug in the topical treatment of acne .\
RESULTS	The three products induced retinoid-like skin irritation with significant differences in intensity in favour of adapalene for erythema , dryness , scaling and burning after application and in favour of tretinoin for persistent burning .\
RESULTS	No treatment-related medical events were reported and adapalene plasma levels were lower than 0.15 ng/ml ( limit of detection of the analytical method ) .\
CONCLUSIONS	The topical treatment of acne with adapalene gels was found to be safe and effective , with a dose-related response .\
CONCLUSIONS	The efficacy of 0.1 p. 100 adapalene gel and of 0.025 p. 100 tretinoin gel are not different but skin tolerance of 0.1 p. 100 adapalene gel is superior .\
\
###23302558\
OBJECTIVE	Many previous meta-analysis have shown that the probiotics can lower the incidence of antibiotic-associated diarrhea ( AAD ) in children .\
OBJECTIVE	However , the function and efficacy of probiotics drugs showed obvious strains specificity and dose dependence .\
OBJECTIVE	Currently , most of the reported meta-analysis regarding probiotics AAD prevention have adopted Saccharomyces , Lactobacilleae , Streptococcus and Bifidobacterium .\
OBJECTIVE	This study aimed to evaluate the efficacy and safety of the live Clostridium butyricum and Bifidobacterium Powder to prevent AAD in hospitalized children with pneumonia .\
METHODS	This study was a multicenter , randomized , controlled clinical trial ; 380 hospitalized children with pneumonia aged from 3 months to 3 years were enrolled from April to Dec. 2011 .\
METHODS	Totally 372 children completed the study , 179 children in control group received antibiotics as routine treatment for pneumonia ; 193 children in treatment group received 510 ( 9 ) colony-forming units of Clostridium butyricum and Bifidobacterium combined Powder daily for 7 days during the antibiotics treatment .\
METHODS	The stool frequency and consistency ( assessed according to the Bristol Excrement Assessment Scale ) were observed for 7 consecutive days ; the incidence of diarrhea and adverse drug reactions were recorded .\
RESULTS	Both treatment and control groups were similar in age distribution , sex , type of antibiotics , route of administration , and time of antibiotics used .\
RESULTS	During the 7 days period , the rate of AAD was 7.8 % ( 13/193 ) in treatment group and 16.8 % ( 30/179 ) in control group , there was significant difference ; compared with the control group , the treatment with Clostridium butyricum and Bifidobacterium combined Powder can lead to 53.6 % reduction in AAD risk ( RR = 0.419 , 95 % CI 0.217 - 0.808 ; P = 0.008 ) .\
RESULTS	The severity of diarrhea was comparable in both study groups , as evidenced by similar stool frequency , dehydration , fever and vomiting .\
RESULTS	There was significant difference ( P = 0.008 ) in the AAD occurrence time distribution between the treatment group and control group .\
RESULTS	No drug related adverse reactions ( ADRs ) were found during the observation period .\
CONCLUSIONS	The live Clostridium butyricum and Bifidobacterium combined Powder may effectively reduce the risk of AAD in hospitalized children with pneumonia , and no ADRs were found .\
\
###15197209\
OBJECTIVE	This analysis of data from a randomized trial of chemotherapy in epithelial ovarian cancer sought to determine whether a relationship exists between the presence and severity of the most commonly observed toxic effects and the corresponding quality of life ( QOL ) items .\
METHODS	One hundred fifty-two eligible patients accrued from Canada by the National Cancer Institute of Canada Clinical Trials Group on a randomized trial of paclitaxel and cisplatin versus cyclophosphamide/cisplatin were included in the analysis .\
METHODS	Toxicity to the chemotherapeutic treatments was subjectively evaluated using a trial-specific checklist for ovarian cancer and the European Organization for Research and Treatment of Cancer QLQ C30 +3 questionnaire .\
METHODS	Assessments were conducted at baseline , before each cycle of treatment ( 3 weeks ) , and at each 3-month follow-up during the next 2 years ( or until progression ) .\
RESULTS	The most frequently observed symptoms experienced during or shortly following chemotherapy were neurosensory loss , lethargy , nausea , vomiting , and alopecia .\
RESULTS	Regression analyses revealed that change scores of QOL items related to motor weakness and gastrointestinal pain were common predictors for the change global QOL score during protocol treatment ; and change scores of QOL items related to lethargy or fatigue and change toxicity grade of mood predicted the change global QOL score after patients were off treatment .\
CONCLUSIONS	The use of the European Organization for Research and Treatment of Cancer QLQ C30 +3 and trial-specific checklist was able to assess the effect of expected toxicities on patient ' s QOL during and following treatment , and so may be useful in addressing the concerns regarding methodological issues that have limited the acquisition of prospective , longitudinal treatment-related toxicity data .\
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###15992986\
BACKGROUND	Although biphasic defibrillation waveforms appear to be superior to monophasic waveforms in terminating VF , their relative benefits in out-of-hospital resuscitation are incompletely understood .\
BACKGROUND	Prior comparisons of defibrillation waveform efficacy in out-of-hospital cardiac arrest ( OHCA ) are confined to patients presenting in a shockable rhythm and resuscitated by first responder ( basic life support ) .\
BACKGROUND	This effectiveness study compared monophasic and biphasic defibrillation waveform for conversion of ventricular arrhythmias in all OHCA treated with advance life support ( ALS ) .\
RESULTS	This prospective randomized controlled trial compared the rectilinear biphasic ( RLB ) waveform with the monophasic damped sine ( MDS ) waveform , using step-up energy levels .\
RESULTS	The study enrolled OHCA patients requiring at least one shock delivered by ALS providers , regardless of initial presenting rhythm .\
RESULTS	Shock success was defined as conversion at 5s to organized rhythm after one to three escalating shocks .\
RESULTS	We report efficacy results for the cohort of patients treated by ALS paramedics who presented with an initially shockable rhythm who had not received a shock from a first responder ( MDS : n = 83 ; RLB : n = 86 ) .\
RESULTS	Shock success within the first three ascending energy shocks for RLB ( 120 , 150 , 200J ) was superior to MDS ( 200 , 300 , 360J ) for patients initially presenting in a shockable rhythm ( 52 % versus 34 % , p = 0.01 ) .\
RESULTS	First shock conversion was 23 % and12 % , for RLB and MDS , respectively ( p = 0.07 ) .\
RESULTS	There were no significant differences in return of spontaneous circulation ( 47 % versus 47 % ) , survival to 24h ( 31 % versus 27 % ) , and survival to discharge ( 9 % versus 7 % ) .\
RESULTS	Mean 24h survival rates of bystander witnessed events showed differences between waveforms in the early circulatory phase at 4-10 min post event ( mean ( S.D. ) RLB 0.45 ( 0.07 ) versus MDS 0.31 ( 0.06 ) , p = 0.0002 ) and demonstrated decline as time to first shock increased to 20 min .\
CONCLUSIONS	Shock success to an organized rhythm comparing step-up protocol for energy settings demonstrated the RLB waveform was superior to MDS in ALS treatment of OHCA .\
CONCLUSIONS	Survival rates for both waveforms are consistent with current theories on the circulatory and metabolic phases of out-of-hospital cardiac arrest .\
\
###22612560\
OBJECTIVE	The present research tested whether an evaluative conditioning intervention makes thin-ideal models less enviable as standards for appearance-based social comparisons ( Study 1 ) , and increases body satisfaction ( Study 2 ) .\
METHODS	Female participants were randomly assigned to intervention versus control conditions in both studies ( ns = 66 and 39 ) .\
METHODS	Intervention participants learned to associate thin-ideal models with synonyms of fake whereas control participants completed an equivalent task that did not involve learning this association .\
METHODS	The dependent variable in Study 1 was an implicit measure of idealization of slim models assessed via a modified Implicit Association Test ( IAT ) .\
METHODS	Study 2 used a validated , self-report measure of body satisfaction as the outcome variable .\
RESULTS	Intervention participants showed significantly less implicit idealization of slim models on the IAT compared to controls ( Study 1 ) .\
RESULTS	In Study 2 , participants who undertook the intervention exhibited an increase in body satisfaction scores whereas no such increase was observed for control participants .\
CONCLUSIONS	The present research indicates that it is possible to overcome the characteristic impact of thin-ideal models on women 's judgments of their bodies .\
CONCLUSIONS	An evaluative conditioning intervention made it less likely that slim models were perceived as targets to be emulated , and enhanced body satisfaction .\
\
###21323786\
OBJECTIVE	To investigate the effect of the selected chemical surface treatment agents on the flexural strength of heat-polymerized acrylic resin repaired with autopolymerized acrylic resin .\
METHODS	Ninety heat-polymerized acrylic resin specimens ( Meliodent ) were prepared according to ISO1567 and randomly divided into nine groups : positive and negative control groups ( groups I and II ) , and seven experimental groups ( groups III to IX ) .\
METHODS	Specimens in groups II to IX were cut in the middle and beveled 45 .\
METHODS	Group III was then treated with methyl methacrylate ( the liquid part of Unifast TRAD ) for 180 seconds .\
METHODS	Group IV was treated with Rebase II adhesive according to the manufacturer 's instructions .\
METHODS	Groups V to IX were treated with methyl formate , methyl acetate , and a mixture of methyl formate-methyl acetate at various concentrations ( 75:25 , 50:50 , 25:75 % v/v , respectively ) for 15 seconds .\
METHODS	They were then repaired with autopolymerized acrylic resin ( Unifast TRAD ) .\
METHODS	A three-point loading test was performed using a universal testing machine .\
METHODS	One-way ANOVA and post hoc Tukey 's analysis at p < 0.05 were used for statistical comparison .\
METHODS	Failure analysis was then recorded for each specimen .\
METHODS	The morphological changes in untreated and treated specimens were observed by scanning electron microscopy .\
RESULTS	The flexural strengths of groups III to IX were significantly higher than that of group II ( p < 0.05 ) .\
RESULTS	The flexural strengths of groups IV to IX showed no significant difference among them ( p > 0.05 ) .\
RESULTS	All specimens in groups V to IX showed 100 % cohesive failure , while groups II , III , and IV showed cohesive failure of 10 % , 60 % , and 60 % , respectively .\
RESULTS	From scanning electron micrographs , the application of methyl formate , methyl acetate , and a mixture of methyl formate-methyl acetate solutions on heat-polymerized acrylic resin resulted in a 3D honeycomb appearance , while specimens treated with methyl methacrylate and Rebase II adhesive developed shallow pits and small crest patterns , respectively .\
CONCLUSIONS	Treating surfaces with methyl formate , methyl acetate , and a mixture of methyl formate-methyl acetate solutions significantly enhanced the flexural strength of heat-polymerized acrylic denture base resin that had been repaired with autopolymerized acrylic resin .\
\
###20976768\
OBJECTIVE	A previous phase 3 study showed significant improvement in walking ability in multiple sclerosis ( MS ) patients treated with oral , extended-release dalfampridine ( 4-aminopyridine ) 10mg twice daily .\
OBJECTIVE	The current study was designed to confirm efficacy and further define safety and pharmacodynamics .\
METHODS	This was a 39-center , double-blind trial in patients with definite MS of any course type .\
METHODS	Participants were randomized to 9 weeks of treatment with dalfampridine ( 10mg twice daily ; n = 120 ) or placebo ( n = 119 ) .\
METHODS	Response was defined as consistent improvement on the Timed 25-Foot Walk , with percentage of timed walk responders ( TWRs ) in each treatment group as the primary outcome .\
METHODS	The last on-treatment visit provided data from 8 to 12 hours postdose , to examine maintenance of effect .\
RESULTS	One patient from each group was excluded from the modified Intention to Treat population .\
RESULTS	The proportion of TWRs was higher in the dalfampridine group ( 51/119 or 42.9 % ) compared to the placebo group ( 11/118 or 9.3 % , p < 0.0001 ) .\
RESULTS	The average improvement in walking speed among dalfampridine-treated TWRs during the 8-week efficacy evaluation period was 24.7 % from baseline ( 95 % confidence interval , 21.0-28 .4 % ) ; the mean improvement at the last on-treatment visit was 25.7 % , showing maintenance of effect over the interdosing period .\
RESULTS	There were no new safety findings .\
CONCLUSIONS	This interventional study provides class 1 evidence that dalfampridine extended-release tablets produce clinically meaningful improvement in walking ability in a subset of people with MS , with the effect maintained between doses .\
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###11763934\
OBJECTIVE	To evaluate the efficacy of four different floss types for interproximal plaque removal on the normal dentition .\
METHODS	24 dental hygiene students tested each of four different floss types : waxed , unwaxed , woven and shred-resistant .\
METHODS	At baseline , all subjects received a prophylaxis to become plaque-free and identical flossing instructions were given .\
METHODS	Subjects were then instructed not to brush , floss , or rinse for 3 days to allow for plaque development .\
METHODS	On the fourth day , each subject 's teeth were disclosed and scored using O'Leary 's Plaque Index .\
METHODS	Subjects were then randomly assigned one of the four floss types to use throughout the dentition , following which a second plaque record was assessed .\
METHODS	Subjects were timed while flossing , and then completed a 10 cm Visual Analogue Scale ( VAS ) scoring their degree of discomfort/comfort and ease of use for each specific type of floss .\
METHODS	This protocol was followed until all four floss types were tested by each subject .\
METHODS	Results analyzed reductions in total interproximal plaque score ( TIPS ) , anterior ( teeth ) interproximal plaque score ( AIPS ) , and posterior ( teeth ) interproximal plaque score ( PIPS ) .\
RESULTS	The greatest reduction in TIPS and PIPS was with waxed floss ( 68.87 % , 66.54 % respectively ) and in AIPS with woven floss ( 75.15 % ) .\
RESULTS	Post-hoc testing using Tukey 's method revealed no significant differences among the four floss types .\
RESULTS	VAS scores revealed shred-resistant most comfortable ( 6.99 ) while unwaxed was least ( 4.29 ) .\
RESULTS	These results indicated minimal differences in the efficacy of different types of floss , their degree of comfort and ease of use .\
\
###8810935\
OBJECTIVE	To study the biological effects of nebulized insulin , administered intrapulmonary , to healthy volunteers .\
METHODS	A double-blind , randomized , controlled intervention study .\
METHODS	The department of Internal Medicine , University Hospital , Linkping , Sweden .\
METHODS	Eight healthy , non-smoking volunteers , with a mean age of 28 ( range 22 to 56 ) years .\
METHODS	Regular human insulin 100 U mL-1 ( Actrapid ) or 0.9 % saline was given randomly as an oral inhalation .\
METHODS	Insulin was given in three different doses ( 40 , 80 and 160 U ) .\
METHODS	Aerosol was generated by a new jet nebulizer .\
METHODS	Blood glucose , serum insulin , and serum C-peptide .\
RESULTS	After the 160 U insulin dose the blood glucose concentration ( mean + / - SE ) fell from 4.3 + / - 0.2 to 2.8 + / - 0.2 mmol L-1 ( P < 0.001 ) , concomitant with an increase in mean serum insulin concentrations , rising from 9.5 + / - 1.5 to 26.1 + / - 2.5 mU L-1 ( P < 0.001 ) .\
RESULTS	Serum C-peptide concentrations simultaneously decreased from 0.48 + / - 0.03 to 0.12 + / - 0.02 mmol L-1 ( P < 0.001 ) .\
RESULTS	All changes were dose dependent .\
RESULTS	No adverse reactions were noted and no significant changes in lung function tests .\
CONCLUSIONS	Intrapulmonary insulin administration to healthy subjects can induce a significant hypoglycaemia and cause a clinically relevant increase in serum insulin concentrations .\
CONCLUSIONS	If similar results can be obtained when administering insulin to diabetic subjects , this insulin administration route can be a future complement to certain groups of patients .\
\
###8358459\
OBJECTIVE	To determine whether the use of patient-controlled analgesia vs intramuscular injections improves postoperative psychological parameters , particularly anxiety .\
METHODS	Randomized , controlled trial of patient-controlled analgesia vs as-needed intramuscular morphine with pre - and postoperative assessments of pain , mental status , narcotic use , anxiety and mood states .\
METHODS	General surgical wards and surgical intensive care unit at a Veterans Administration hospital .\
METHODS	Eighty-three elderly , chronically ill males undergoing major elective surgery .\
METHODS	Subjects randomized to receive postoperative patient-controlled analgesia vs as-needed intramuscular morphine .\
METHODS	Pre - and postoperative assessments of State-Trait Anxiety Inventory , McGill-Dartmouth Part IV and Short Portable Mental Status Questionnaire .\
METHODS	Pain ( using linear analog scale ) , sedation score and narcotic use assessed every 4 hours for 72 hours .\
RESULTS	No differences were found in state anxiety or self-perceived mood states .\
RESULTS	Postoperative state anxiety was found to relate most closely to preoperative anxiety and postoperative complications , rather than method of analgesia or severity of pain .\
RESULTS	However , patient-controlled analgesia subjects had significantly improved analgesia and increased satisfaction .\
CONCLUSIONS	The use of patient-controlled analgesia does not significantly alter the measured psychological parameters , compared with intramuscular injections .\
CONCLUSIONS	Improved analgesia is the result of pharmacologic effects , independent of psychological factors .\
\
###20105416\
OBJECTIVE	This study examined the associations of pretreatment and posttreatment depressive symptoms with drinking outcomes in the year following treatment in Project MATCH ( Matching Alcoholism Treatments to Client Heterogeneity ) , a multisite clinical trial of behavioral treatments for alcohol-use disorders .\
METHODS	Data from 1,726 participants were modeled using generalized estimating equations to examine drinking frequency and intensity , as reflected by percentage days abstinent ( PDA ) and average drinks per drinking day ( DDD ) .\
METHODS	We predicted that patients who reported more pretreatment and posttreatment depressive symptoms would report greater drinking frequency ( PDA ) and more intense drinking ( DDD ) across the 12-month follow-up period .\
RESULTS	Pretreatment Beck Depression Inventory ( BDI ) scores predicted more frequent and intense drinking in the year following treatment , although not after accounting for posttreatment BDI scores , which were associated with the drinking outcomes as hypothesized .\
RESULTS	Patients who reported more depressive symptoms in the year following treatment reported less abstinence ( PDA ) and more intense drinking ( DDD ) than patients with fewer posttreatment depressive symptoms .\
CONCLUSIONS	Our findings underscore the importance of obtaining repeated assessments of depression during the course of substance use treatment .\
CONCLUSIONS	Moreover , the data suggest the potential utility of augmenting standard chemical dependency care with depression-focused interventions for alcohol-dependent patients whose depressive symptoms do not subside during treatment .\
\
###24120480\
BACKGROUND	Previous results of the EORTC intergroup trial 40983 showed that perioperative chemotherapy with FOLFOX4 ( folinic acid , fluorouracil , and oxaliplatin ) increases progression-free survival ( PFS ) compared with surgery alone for patients with initially resectable liver metastases from colorectal cancer .\
BACKGROUND	Here we present overall survival data after long-term follow-up .\
METHODS	This randomised , controlled , parallel-group , phase 3 study recruited patients from 78 hospitals across Europe , Australia , and Hong Kong .\
METHODS	Eligible patients aged 18-80 years who had histologically proven colorectal cancer and up to four liver metastases were randomly assigned ( 1:1 ) to either perioperative FOLFOX4 or surgery alone .\
METHODS	Perioperative FOLFOX4 consisted of six 14-day cycles of oxaliplatin 85mg/m ( 2 ) , folinic acid 200 mg/m ( 2 ) ( DL form ) or 100 mg/m ( 2 ) ( L form ) on days 1-2 plus bolus , and fluorouracil 400 mg/m ( 2 ) ( bolus ) and 600 mg/m ( 2 ) ( continuous 22 h infusion ) , before and after surgery .\
METHODS	Patients were centrally randomised by minimisation , adjusting for centre and risk score and previous adjuvant chemotherapy to primary surgery for colorectal cancer , and the trial was open label .\
METHODS	Analysis of overall survival was by intention to treat in all randomly assigned patients .\
RESULTS	Between Oct 10 , 2000 , and July 5 , 2004 , 364 patients were randomly assigned to a treatment group ( 182 patients in each group , of which 171 per group were eligible and 152 per group underwent resection ) .\
RESULTS	At a median follow-up of 85 years ( IQR 76-95 ) , 107 ( 59 % ) patients in the perioperative chemotherapy group had died versus 114 ( 63 % ) in the surgery-only group ( HR 088 , 95 % CI 068-114 ; p = 034 ) .\
RESULTS	In all randomly assigned patients , median overall survival was 613 months ( 95 % CI 510-834 ) in the perioperative chemotherapy group and 543 months ( 419-794 ) in the surgery alone group .\
RESULTS	5-year overall survival was 512 % ( 95 % CI 436-583 ) in the perioperative chemotherapy group versus 478 % ( 403-550 ) in the surgery-only group .\
RESULTS	Two patients in the perioperative chemotherapy group and three in the surgery-only group died from complications of protocol surgery , and one patient in the perioperative chemotherapy group died possibly as a result of toxicity of protocol treatment .\
CONCLUSIONS	We found no difference in overall survival with the addition of perioperative chemotherapy with FOLFOX4 compared with surgery alone for patients with resectable liver metastases from colorectal cancer .\
CONCLUSIONS	However , the previously observed benefit in PFS means that perioperative chemotherapy with FOLFOX4 should remain the reference treatment for this population of patients .\
BACKGROUND	Norwegian and Swedish Cancer Societies , Cancer Research UK , Ligue Nationale Contre Cancer , US National Cancer Institute , Sanofi-Aventis .\
\
###19839944\
BACKGROUND	The bispectral index ( BIS ) and spectral entropy enable monitoring the depth of anaesthesia .\
BACKGROUND	Mild hypothermia has been shown to affect the ability of electroencephalography monitors to reflect the anaesthetic drug effect .\
BACKGROUND	The purpose of this study was to investigate the effect of hypothermia during a cardio-pulmonary bypass on the correlation and agreement between the BIS and entropy variables compared with normothermic conditions .\
METHODS	This prospective clinical study included coronary artery bypass grafting patients ( n = 25 ) evaluating correlation and agreement ( Bland-Altman analysis ) between the BIS and both spectral and response entropy during a hypothermic cardio-pulmonary bypass ( 31-34 degrees C ) compared with nomothermic conditions ( 34-37 .5 degrees C ) .\
METHODS	Anaesthesia was maintained with propofol and sufentanil and adjusted clinically , while the anaesthetist was blinded to the monitors .\
RESULTS	The BIS and entropy values decreased during cooling ( P < 0.05 ) , but the decrease was more pronounced for entropy variables compared with BIS ( P < 0.05 ) .\
RESULTS	The correlation coefficients ( bias + / - SD ; percentage error ) between the BIS vs. spectral state entropy and response entropy were r ( 2 ) = 0.56 ( 1 + / -11 ; 42 % ) and r ( 2 ) = 0.58 ( -2 + / -11 ; 43 % ) under normothermic conditions , and r ( 2 ) = 0.17 ( 10 + / -12 ; 77 % ) and r ( 2 ) = 0.18 ( 9 + / -11 ; 68 % ) under hypothermic conditions , respectively .\
RESULTS	Bias was significantly increased under hypothermic conditions ( P < 0.001 vs. normothermia ) .\
CONCLUSIONS	Acceptable agreement was observed between the BIS and entropy variables under normothermic but not under hypothermic conditions .\
CONCLUSIONS	The BIS and entropy variables may therefore not be interchangeable during a hypothermic cardio-pulmonary bypass .\
\
###24084625\
BACKGROUND	Although the reduction in mortality with bivalirudin compared with unfractionated heparin plus glycoprotein IIb/IIIa inhibitors in the Harmonizing Outcome with Revascularization and Stent in Acute Myocardial Infarction ( HORIZONS-AMI ) trial has been attributed to lower rates of major bleeding , alternative mechanisms have not been investigated in depth .\
BACKGROUND	We sought to investigate whether there might be an interaction between white blood cell ( WBC ) count and bivalirudin for the risk of mortality , and whether this interaction is independent of major bleeding .\
RESULTS	Among the 3602 patients enrolled in the HORIZONS-AMI trial , WBC count was available in 3433 ( 95.3 % ) patients .\
RESULTS	Patients were stratified according to WBC tertiles .\
RESULTS	At 1-year follow-up , bivalirudin was associated with significantly lower rates of mortality and cardiac mortality compared with unfractionated heparin plus glycoprotein IIb/IIIa inhibitors in patients in the upper WBC tertile ( all-cause death : 4.1 % versus 9.3 % , respectively ; P = 0.0004 ; cardiac death : 2.0 % versus 6.9 % ; respectively ; P < 0.0001 ) but not in patients in the mid-WBC or lower WBC tertiles .\
RESULTS	The reduction of mortality with bivalirudin across WBC tertiles was independent of major bleeding , and a significant interaction was apparent for 1-year all-cause mortality and cardiac mortality between WBC and bivalirudin therapy .\
RESULTS	Similar findings were apparent at 3 years .\
CONCLUSIONS	In patients with ST-segment-elevation myocardial infarction , a significant interaction between bivalirudin therapy and admission WBC count was apparent for 1-year mortality .\
CONCLUSIONS	The reduction in mortality was independent of major bleeding , suggesting that other mechanisms may be implicated in the survival benefit observed with bivalirudin .\
BACKGROUND	http://www.clinicaltrials.gov .\
BACKGROUND	Unique identifier : NCT00433966 .\
\
###15237694\
BACKGROUND	Atrial fibrillation ( AF ) is the most common complication following coronary artery bypass graft ( CABG ) .\
BACKGROUND	The mechanism of AF after CABG is not well defined ; however , it is suggested that endogenous adenosine , released in response to tissue hypoxia , may play a mechanistic role in these arrhythmias .\
OBJECTIVE	The purpose of this study was to examine whether intravenous theophylline , via adenosine A1 receptor antagonism , would correct or modify new-onset early ( < 48 h post CABG ) atrial fibrillation in patients post CABG , and thereby implicate endogenous adenosine as an inciting agent .\
METHODS	A prospective double-blind , placebo-controlled study design was applied to 385 consecutive patients with coronary artery disease who had undergone CABG .\
METHODS	Any patient who developed AF within 48 h of the operative procedure was randomly assigned to receive 5 mg/kg of intravenous theophylline ( Group A ) or matched intravenous placebo ( Group B ) .\
METHODS	The patients who converted to sinus rhythm within 15 min of drug administration were accepted as showing positive responses .\
RESULTS	Thirty patients comprised the study group .\
RESULTS	In Group A , 8 of the 15 patients ( 53 % ) converted from AF to sinus rhythm within 15 min of theophylline administration .\
RESULTS	One patient who converted to sinus rhythm 20 min after theophylline administration was accepted as showing a negative response .\
RESULTS	In the placebo-treated group , no patient converted to sinus rhythm within 15 min ( p < 0.007 compared with Group A ) .\
CONCLUSIONS	The mechanism of AF after CABG is not well defined and is probably multifactorial .\
CONCLUSIONS	However , this study demonstrated that antagonism of the adenosine A1 receptor can promptly convert many of these patients back to sinus rhythm , and thereby implicates endogenously released adenosine in a mechanistic role for inciting early ( < 48 h ) post-CABG AF .\
\
###9180103\
OBJECTIVE	This prospective , randomized , double-blind multicenter trial evaluated the efficacy and safety of a single bolus injection of the novel modified tissue-type plasminogen activator ( t-PA ) E6010 in the treatment of acute myocardial infarction compared with that of native t-PA .\
BACKGROUND	E6010 is a novel modified t-PA with a prolonged half-life ( t1/2 alpha > or = 23 min ) compared with native t-PA ( t1/2 alpha = 4 min ) .\
BACKGROUND	E6010 can be administered in patients as a single intravenous bolus injection , and early recanalization can be expected .\
METHODS	The efficacy of E6010 was compared with that of native t-PA in 199 patients with acute myocardial infarction who were treated within 6 h of onset in a prospective , randomized , double-blind multicenter trial .\
METHODS	Patients were given either 0.22 mg/kg body weight of E6010 intravenously over 2 min or native t-PA ( tisokinase ) 28.8 mg or 14.4 million IU ( 10 % of the total dose over 1 to 2 min , the remainder infused over 60 min ) .\
RESULTS	The primary end point was the recanalization rate of the infarct-related coronary artery at 60 min after the start of treatment .\
RESULTS	Time to reperfusion was shorter in the E6010 group than in the native t-PA group .\
RESULTS	Thrombolysis in Myocardial Infarction flow grade 2 or 3 recanalization at 15 , 30 , 45 and 60 min after administration was observed in 37 % , 62 % , 74 % and 79 % ( 95 % confidence interval [ CI ] 70 % to 87 % ) of the E6010-treated patients and in 14 % , 32 % , 50 % and 65 % ( 95 % CI 55 % to 74 % ) of native t-PA-treated patients , respectively ( p = 0.032 at 60 min ) .\
CONCLUSIONS	The present study indicates that , compared with native t-PA , a single bolus injection of E6010 over 2 min produces a higher rate of early recanalization of the infarct-related coronary artery without fatal bleeding complications .\
\
###17312085\
BACKGROUND	Persons with Parkinson disease ( PD ) exhibit decreased muscular fitness including decreased muscle mass , muscle strength , bioenergetic capabilities and increased fatigability .\
OBJECTIVE	This purpose of this investigation was to evaluate the therapeutic effects of resistance training with and without creatine supplementation in patients with mild to moderate PD .\
METHODS	Twenty patients with idiopathic PD were randomized to receive creatine monohydrate supplementation plus resistance training ( CRE ) or placebo ( lactose monohydrate ) plus resistance training ( PLA ) , using a double-blind procedure .\
METHODS	Creatine and placebo supplementation consisted of 20 g/d for the first 5 days and 5 g/d thereafter .\
METHODS	Both groups participated in progressive resistance training ( 24 sessions , 2 times per week , 1 set of 8-12 repetitions , 9 exercises ) .\
METHODS	Participants performed 1-repetition maximum ( 1-RM ) for chest press , leg extension , and biceps curl .\
METHODS	Muscular endurance was evaluated for chest press and leg extension as the number of repetitions to failure using 60 % of baseline 1-RM .\
METHODS	Functional performance was evaluated as the time to perform 3 consecutive chair rises .\
RESULTS	Statistical analyses ( ANOVA ) revealed significant Group x Time interactions for chest press strength and biceps curl strength , and post hoc testing revealed that the improvement was significantly greater for CRE .\
RESULTS	Chair rise performance significantly improved only for CRE ( 12 % , P = .03 ) .\
RESULTS	Both PLA and CRE significantly improved 1-RM for leg extension ( PLA : 16 % ; CRE : 18 % ) .\
RESULTS	Muscular endurance improved significantly for both groups .\
CONCLUSIONS	These findings demonstrate that creatine supplementation can enhance the benefits of resistance training in patients with PD .\
\
###22939029\
OBJECTIVE	Treatments for the cognitive impairments of schizophrenia are urgently needed .\
OBJECTIVE	We developed and tested a 12-week , group-based , manualized , compensatory cognitive training intervention targeting prospective memory , attention , learning/memory , and executive functioning .\
OBJECTIVE	The intervention focused on compensatory strategies , such as calendar use , self-talk , note taking , and a 6-step problem-solving method , and did not require computers .\
METHODS	In a randomized controlled trial , 69 outpatients with DSM-IV primary psychotic disorders were assigned to receive standard pharmacotherapy alone or compensatory cognitive training + standard pharmacotherapy for 12 weeks .\
METHODS	Assessments of neuropsychological performance and functional capacity ( primary outcomes ) and psychiatric symptom severity , quality of life , social skills performance , cognitive insight , and self-reported everyday functioning ( secondary outcomes ) were administered at baseline , posttreatment , and 3-month follow-up .\
METHODS	Data were collected between September 2003 and August 2009 .\
RESULTS	Hierarchical linear modeling analyses demonstrated significant compensatory cognitive training-associated effects on attention at follow-up ( P = .049 ) , verbal memory at posttreatment and follow-up ( P values .039 ) , and functional capacity ( University of California , San Diego Performance-based Skills Assessment ) at follow-up ( P = .004 ) .\
RESULTS	The compensatory cognitive training group also differentially improved in negative symptom severity at posttreatment and follow-up ( P values .025 ) and subjective quality of life at follow-up ( P = .002 ) .\
CONCLUSIONS	Compensatory cognitive training , a low-tech , brief intervention , has the potential to improve not only cognitive performance but also functional skills , negative symptoms , and self-rated quality of life in people with psychosis .\
BACKGROUND	ClinicalTrials.gov identifier : NCT01521026 .\
\
###23598734\
BACKGROUND	The effects of anesthetics on inflammation and oxidative parameters , evaluated in patients without comorbidities undergoing minor surgery , remain unknown .\
BACKGROUND	The present study aimed to investigate the inflammatory and oxidative stress status in adult patients undergoing elective minimally invasive surgery , using different anesthetic techniques .\
METHODS	Thirty patients classified as ASA physical status I , who were scheduled for minor surgeries ( tympanoplasty or septoplasty ) , were randomly allocated into two groups : balanced ( BAL ) anesthesia maintained with isoflurane or total intravenous anesthesia ( TIVA ) with propofol .\
METHODS	Blood samples were drawn prior to the induction of anesthesia ( baseline ) , 120 min after the beginning of anesthesia and one day after surgery .\
METHODS	The proinflammatory cytokine IL-6 was determined by flow cytometry ; DNA oxidation was evaluated by the single cell gel electrophoresis assay , and plasma malondialdehyde ( lipid peroxidation biomarker ) and antioxidant status were determined through fluorometry .\
RESULTS	Increased IL-6 was observed one day after surgery in both groups ( P = 0.0001 ) .\
RESULTS	Malondialdehyde levels did not change among the time points assessed or between the groups ( P > 0.05 ) .\
RESULTS	Whereas BAL anesthesia had no effect on acid nucleic and antioxidant status , TIVA decreased oxidized/alkylated purines ( P = 0.03 ) and increased antioxidant status ( P = 0.002 ) during anesthesia .\
RESULTS	The two groups did not differ significantly in DNA oxidation or antioxidant status ( P > 0.05 ) .\
CONCLUSIONS	BAL anesthesia maintained with isoflurane and TIVA maintained with propofol are safe by virtue of not causing oxidative stress status in ASA physical status I patients undergoing minimally invasive surgeries .\
CONCLUSIONS	Moreover , even in minor surgeries , TIVA with propofol produces an antioxidant effect in patients .\
\
###21684490\
OBJECTIVE	Is Strain-Counterstrain treatment combined with exercise therapy more effective than exercise alone in reducing levels of pain and disability in people with acute low back pain ?\
METHODS	Randomised trial with concealed allocation , assessor blinding , and intention-to-treat analysis .\
METHODS	89 ( 55 female ) participants between 18 and 55 years experiencing acute low back pain were randomised to experimental ( n = 44 ) and control ( n = 45 ) groups .\
METHODS	Participants attended four treatments in two weeks .\
METHODS	The experimental group received Strain-Counterstrain treatment and review of standardised exercises ( abdominal bracing , knee to chest , and lumbar rotation ) .\
METHODS	The control group performed the standardised exercises under supervision .\
METHODS	Following the intervention period , all participants received exercise progression , manual therapy , and advice .\
METHODS	The primary outcome was the modified Oswestry low back pain disability questionnaire , measured at 2 weeks ( ie , end of treatment ) , 6 weeks , and 28 weeks .\
METHODS	Secondary outcome measures included the SF-36 , visual analogue scale pain ratings , and a 7-point global rating of change .\
RESULTS	The experimental intervention was not more effective than exercise alone in reducing levels of pain and disability .\
RESULTS	Mean between-group differences in change from baseline for the Oswestry Disability Index were 0 ( 95 % CI -6 to 7 ) after treatment , -1 ( 95 % CI -7 to 6 ) at 6 weeks , and 2 ( 95 % CI -4 to 8 ) at 28 weeks .\
RESULTS	Other outcomes did not differ significantly between groups .\
CONCLUSIONS	There is no advantage in providing Strain - Counterstrain treatment to patients with acute low back pain , although further studies could examine whether a subset of these patients can benefit from the treatment .\
BACKGROUND	ACTRN 12609000084280 .\
\
###10676670\
OBJECTIVE	The aims of this study were to determine whether chronic or acute impairment of flow mediated vasodilation ( FMD ) in the brachial artery of smokers can be restored or preserved by the antioxidant vitamin E.\
BACKGROUND	Transient impairment of endothelial function after heavy cigarette smoking and chronic endothelial dysfunction in smokers result at least in part from increased oxidative stress .\
METHODS	We studied 22 healthy male smokers ( mean + / - SD , 23 + / - 9 cigarettes per day ) randomly assigned to receive either 600 IU vitamin E per day ( n = 11 , age 28 + / - 6 years ) or placebo ( n = 11 , age 27 + / - 6 years ) for four weeks and 11 age-matched healthy male nonsmokers .\
METHODS	Flow mediated vasodilation and endothelium-independent , nitroglycerin-induced dilation were assessed in the brachial artery using high resolution ultrasound ( 7.5 MHz ) at baseline and after therapy .\
METHODS	Subjects stopped smoking 2 h before the ultrasound examinations .\
METHODS	At the end of the treatment period , a third scan was obtained 20 min after smoking a cigarette ( 0.6 mg nicotine , 7 mg tar ) to estimate transient impairment of FMD .\
RESULTS	Flow mediated vasodilation at baseline was abnormal in the vitamin E ( 5.3 + / - 3.8 , p < 0.01 ) and in the placebo group ( 6.4 + / - 3.5 , p < 0.05 ) compared with nonsmoking controls ( 11.6 + / - 4.7 ) .\
RESULTS	Using a two-way repeated measures analysis of variance ( ANOVA ) to examine the effects of vitamin E on FMD , we found no effect for the grouping factor ( p = 0.5834 ) in the ANOVA over time but a highly significant difference with respect to time ( p = 0.0065 ) .\
RESULTS	The interaction of the time factor and the grouping factor also proved to be significant ( p = 0.0318 ) .\
RESULTS	Flow mediated vasodilation values remained similar after treatment for four weeks in both groups but declined faster after smoking a cigarette in subjects taking placebo compared with those receiving vitamin E ( p values from successive differences for the time/group factor : 0.0001 / 0.0017 ) .\
RESULTS	The transient attenuation of FMD ( calculated as the percent change in FMD ) was related to the improvement of the antioxidant status , estimated as percent changes in thiobarbituric acid-reactive substances ( r = -0.67 , p = 0.0024 ) .\
RESULTS	Nitroglycerin-induced dilation did not differ between study groups at baseline or after therapy .\
CONCLUSIONS	These results demonstrate that oral supplementation of vitamin E can attenuate transient impairment of endothelial function after heavy smoking due to an improvement of the oxidative status but can not restore chronic endothelial dysfunction within four weeks in healthy male smokers .\
\
###15353532\
BACKGROUND	There is no established pharmacological treatment for the core symptoms of chronic fatigue syndrome ( CFS ) .\
BACKGROUND	Galantamine hydrobromide , an acetyl cholesterone inhibitor , has pharmacological properties that might benefit patients with CFS .\
OBJECTIVE	To compare the efficacy and tolerability of galantamine hydrobromide in patients with CFS .\
METHODS	Randomized , double-blind trial conducted June 1997 through July 1999 at 35 outpatient centers in the United Kingdom ( n = 17 ) , United States ( n = 14 ) , the Netherlands ( n = 2 ) , Sweden ( n = 1 ) , and Belgium ( n = 1 ) involving 434 patients with a clinical diagnosis of CFS ( modified US Centers for Disease Control and Prevention criteria ) .\
METHODS	A total of 89 patients were randomly assigned to receive 2.5 mg of galantamine hydrobromide ; 86 patients , 5.0 mg ; 91 patients , 7.5 mg ; and 86 patients , 10 mg ( these patients received medicine in the tablet form 3 times per day ) ; a total of 82 patients received matching placebo tablets 3 times per day .\
METHODS	The primary efficacy variable was the global change on the Clinician Global Impression Scale after 4 , 8 , 12 , and 16 weeks of treatment .\
METHODS	Secondary outcomes were changes in core symptoms of CFS on the Chalder Fatigue Rating Scale , the Fibromyalgia Impact Questionnaire , and the Pittsburgh Sleep Quality Index ; changes in quality of life on the Nottingham Health Profile ; and assessment of plasma-free cortisol levels and cognitive performance on a computer-based battery of tests .\
RESULTS	After 16 weeks , there were no statistically significant differences between any of the galantamine or placebo groups in clinical condition on the Clinician Global Impression Scale , or for any of the secondary end points .\
RESULTS	Exploratory regression analysis failed to detect any consistent prognostic factor that might have influenced the primary or any secondary outcome measures .\
CONCLUSIONS	This trial did not demonstrate any benefit of galantamine over placebo in the treatment of patients with CFS .\
\
###20160637\
OBJECTIVE	The aim of this study was to evaluate the safety of this trial with respect to morbidity and mortality .\
BACKGROUND	Laparoscopic-assisted distal gastrectomy ( LADG ) is rapidly gaining popularity .\
BACKGROUND	However , there is limited evidence regarding its oncologic safety .\
BACKGROUND	We therefore conducted a phase III multicenter , prospective , randomized study comparing LADG with open gastrectomy ( ODG ) .\
METHODS	Patient eligibility criteria were pathologically-proven adenocarcinoma , 20 to 80 years of age , preoperative stage I , no history of other cancer , chemotherapy , or radiotherapy .\
METHODS	The primary end point was to determine whether there is a difference in overall survival between 2 groups .\
METHODS	The morbidity and mortality were compared to evaluate the safety of this trial .\
METHODS	The time was decided on the hypothesis that the morbidity of this trial was not significantly different from that of previous reports on open gastric cancer surgeries ( 17 % -20 % ) .\
METHODS	This study is registered at ClinicalTrials.gov and carries the following ID number : NCT00452751 .\
RESULTS	A total of 342 patients were randomized ( LADG , 179 patients ; ODG , 161 patients ) between January 1 , 2006 and July 19 , 2007 .\
RESULTS	There were no significant differences between the 2 groups in age , gender , and comorbidities .\
RESULTS	The postoperative complication rates of the LADG and ODG groups were 10.5 % ( 17/179 ) and 14.7 % ( 24/163 ) , respectively ( P = 0.137 ) .\
RESULTS	Reoperations were required in 3 cases each group .\
RESULTS	The postoperative mortality was 1.1 % ( 2/179 ) and 0 % ( 0/163 ) in the LADG and ODG groups ( P = 0.497 ) , respectively .\
CONCLUSIONS	There was no significance difference in the morbidity and mortality between the 2 groups .\
CONCLUSIONS	Therefore , we conclude that this trial is safe and is thus ongoing .\
\
###25093611\
BACKGROUND	Dexamethasone ( DEXA ) is commonly used to reduce brain swelling during neurosurgical procedures .\
BACKGROUND	DEXA , however , has many side-effects that can increase the risks of post-operative complications .\
BACKGROUND	In contrast , progesterone ( PRO ) has fewer side-effects and has been found to be neuroprotective on traumatic brain injury ( TBI ) .\
BACKGROUND	Whether PRO may be used as an alternative to DEXA during routine procedures has not been fully explored .\
OBJECTIVE	To compare the effects of DEXA and PRO on surgical brain injury ( SBI ) .\
METHODS	Seventy-five adult male Sprague Dawley rats were randomized into five groups : ( 1 ) SBI + drug vehicle ( peanut oil , 1ml kg ( -1 ) ) ; ( 2 ) SBI + DEXA ( 1mg kg ( -1 ) ) ; ( 3 ) SBI + low-dose PRO ( 10mg kg ( -1 ) ) ; ( 4 ) SBI + high-dose PRO ( 20mg kg ( -1 ) ) ; and ( 5 ) sham SBI + drug vehicle .\
METHODS	Magnetic resonance imaging study and assessments of brain water content ( BWC ) , blood-brain barrier ( BBB ) permeability , cellular inflammatory responses and matrix metalloproteinase 9 ( MMP-9 ) expression were conducted .\
RESULTS	This model consistently resulted in increased BWC and BBB disruption .\
RESULTS	PRO reduced astrocyte and microglia responses and attenuated brain oedema with preservation of BBB .\
RESULTS	A significant down-regulation of MMP-9 expression occurred in the PRO 20 group .\
CONCLUSIONS	PRO is as effective as DEXA in reducing brain oedema and inflammation following SBI ; 10mg kg ( -1 ) of PRO was demonstrated to be more effective in relieving acute cellular inflammatory responses .\
\
###17376253\
OBJECTIVE	Propofol is associated with pain on injection .\
OBJECTIVE	It is common practice to premix lidocaine with propofol prior to injection .\
OBJECTIVE	Lipuro propofol , a propofol emulsified in medium - and long-chain triglycerides , has been shown to reduce the intensity of injection pain compared to Diprivan , although a number of studies report no reduction in overall incidence of pain .\
METHODS	We conducted this randomized double-blind trial to determine the extent of further pain reduction by adding lidocaine to Lipuro propofol .\
METHODS	A total of 328 ASA I-III patients were randomized to one of four groups to receive Diprivan propofol ( Group DP ) , Lipuro propofol ( Group LP ) , Diprivan with lidocaine ( Group DL ) and Lipuro propofol with lidocaine ( Group LL ) .\
METHODS	The drug mixture was administered at a constant rate of 400 mL h ( -1 ) via a 20-G cannula into a dorsal hand vein .\
METHODS	Pain was assessed during induction and upon patient recovery , using a 10-point visual analogue scale .\
RESULTS	Both the incidence and severity of pain were found to be significantly lower with addition of lidocaine to Lipuro propofol ( P < 0.0002 ) compared to Lipuro alone , Diprivan with or without the addition of lidocaine .\
CONCLUSIONS	Lidocaine added to Lipuro propofol makes induction of anaesthesia less painful compared to Lipuro propofol alone or Diprivan with lidocaine .\
\
###15358015\
OBJECTIVE	We sought to assess the efficacy of vascular brachytherapy ( VBT ) combined with stenting for the primary prevention of restenosis .\
BACKGROUND	Intravascular brachytherapy after stent implantation for de novo lesions has been abandoned for the present .\
BACKGROUND	We revisited this procedure by optimizing all procedural steps-the use of glycoprotein IIb/IIa blockers , direct stenting , adequate radiation coverage , avoidance of edge damage , source centering , intravascular ultrasound-guided dosimetry , and continuation of a dual anti-platelet regimen for one year .\
METHODS	The Beta-Radiation Investigation with Direct stenting and Galileo in Europe ( BRIDGE ) study is a multicenter , randomized controlled trial evaluating the long-term efficacy of VBT with P-32 ( 20 Gy at 1 mm in the coronary wall ) after direct stenting .\
METHODS	The primary end point was angiographic intra-stent late loss ; secondary end points were six months binary restenosis and neo-intimal hyperplasia .\
METHODS	Patients ( n = 112 ) with de novo lesions ( 2.5 to 4.0 mm in diameter up to 15 mm long ) were randomized to either VBT or no-VBT .\
RESULTS	At six months , intra-stent loss was 0.43 and 0.84 mm ( p < 0.001 ) in the irradiated and control groups , respectively .\
RESULTS	Intra-stent neo-intimal volume was reduced from 36 mm3 to 10 mm3 .\
RESULTS	However , in the irradiated group there were six late occlusions as well as eight restenoses outside the stented and peri-stented area at the fall-off dose edges of the irradiated area .\
RESULTS	Accordingly , the target vessel revascularization and major adverse cardiac and cerebrovascular events rates at one year in the VBT group ( 20.4 % and 25.9 % , respectively ) were higher than in the control group ( 12.1 % and 17.2 % , respectively ) .\
CONCLUSIONS	Despite the optimization of pre - , peri - , and post-procedural factors and despite the relative efficacy of the brachytherapy for the prevention of the intra-stent neo-intimal hyperplasia , the clinical outcome of the irradiated group was less favorable than that of the control group .\
\
###15650498\
OBJECTIVE	The aim of this study was to examine the selegiline treatment compared to methylphenidate ( MPH ) in children and adolescents with attention deficit hyperactivity disorder ( ADHD ) .\
METHODS	Forty subjects , aged 6-15 years , boys and girls , who were diagnosed as having ADHD , using the criteria of the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition ( DSM-IV ) , were randomly assigned to receive either selegiline or MPH for 60 days .\
METHODS	Treatment outcomes were assessed using the Attention Deficit Hyperactivity Scale ( ADHS ) administered at baseline and on days 14 , 28 , 42 , and 60 following the commencement of treatment .\
METHODS	Side effects were also rated .\
RESULTS	There were no significant differences between sex , age , weight , and ethnicity of participants in the 2 groups .\
RESULTS	Both groups showed a significant improvement over the 60 days of treatment resulting from the teachers ' and parents ' ADHS scores across the treatment .\
CONCLUSIONS	Following the trial , MPH did not effect greater mean improvement as a result of the parents ' or teachers ' ADHS scores than selegiline .\
CONCLUSIONS	Thus , selegiline appears to be effective and well tolerated for ADHD in children and adolescents .\
\
###25425373\
OBJECTIVE	The purpose of this study was to quantify the time required for transvaginal cervical length measurements during a second-trimester anatomy scan and to evaluate patient attitudes regarding cervical length assessment .\
METHODS	Consenting women were randomly assigned to one of the following : ( 1 ) standard arm-cervix visualized , no prespecified cervical length measurement ; ( 2 ) sequential arm-3 transabdominal cervical length measurements obtained , transvaginal sonography performed if images were inadequate or if any measurement was 3 cm or less ; and ( 3 ) screening transvaginal sonography arm-3 transvaginal cervical length measurements obtained .\
METHODS	Times were recorded for the entire examination and cervical length evaluation .\
METHODS	Participants completed a questionnaire at the end of their visits .\
RESULTS	Sixty of 230 eligible women enrolled .\
RESULTS	Demographic characteristics were similar across groups except for body mass index , which was greater in the sequential arm than the screening arm ( mean SD , 28.5 7.75 versus 24.7 3.89 kg/m ( 2 ) ; P = .03 ) .\
RESULTS	There were no differences in total examination times between the 3 arms ( 24.8 8.59 versus 27.8 8.75 versus 28.5 7.78 minutes ; P = .39 ) .\
RESULTS	There were no differences across groups in participant attitudes regarding examination discomfort or embarrassment .\
CONCLUSIONS	Performing screening transvaginal sonography to measure cervical length did not have a statistically significant impact on the amount of time for completion of the entire examination .\
CONCLUSIONS	Participants had positive responses regarding cervical length assessment by transabdominal and transvaginal sonography .\
\
###18241645\
OBJECTIVE	To evaluate the efficacy and safety of Danning Tablet ( DNT ) in patients with non-alcoholic fatty liver disease ( NAFLD ) of damp-heat syndrome type .\
METHODS	A multicenter , randomized , double-blinded and positive drug parallel controlled trial was performed .\
METHODS	One hundred and thirty-five patients were enrolled into the study and divided into two groups : DNT-treated group ( n = 102 ) and ursodeoxycholic acid ( UDCA ) - treated group ( n = 33 ) .\
METHODS	Body mass index ( BMI ) , principal symptoms , liver function , blood lipids , iconographic , and compositional parameters were measured before and after treatment , respectively .\
RESULTS	In the two groups , BMI , distress in hepatic region , fatigue , anorexia , liver function , blood lipids and iconographic parameters were significantly improved , and the improvements of BMI , distress in hepatic region were better in DNT-treated group than in UDCA-treated group .\
RESULTS	The histological study also showed that DNT had positive effect in treatment of NAFLD .\
CONCLUSIONS	DNT is an effective drug to treat patients with NAFLD of damp-heat syndrome type and is more effective than UDCA .\
\
###21496081\
BACKGROUND	Studies investigating the clinical efficacy of albuterol administered with the same propellant and commercially available delivery devices in horses with recurrent airway obstruction ( RAO ) are not currently available .\
OBJECTIVE	To determine the efficacy of aerosolised albuterol administered to horses with RAO by means of 2 commercially available , hand-held delivery devices .\
METHODS	Ten horses with RAO were kept in a dusty environment and fed mouldy hay to induce airway obstruction .\
METHODS	Lung mechanics were measured before and after the procedure .\
METHODS	P ( max ) was measured 5 min after administration of 180 g of albuterol from a pressurised metered dose inhaler , using an aerosol delivery device chosen randomly .\
METHODS	This process was repeated every 5 min until maximal bronchodilation was achieved .\
METHODS	After a 24 h washout period , lung mechanics data were again collected using the other aerosol delivery device .\
RESULTS	Aerosolised albuterol induced a significant and rapid bronchodilation in the horses using both aerosol delivery devices .\
RESULTS	No statistically significant difference in pulmonary function was observed in response to albuterol therapy between the 2 devices .\
RESULTS	The dose required to achieve 50 % of maximal bronchodilation was not statistically different between the 2 devices ( 173.35 78.35 g with Device 1 and 228.49 144.99 g with Device 2 , P = 0.26 ) .\
RESULTS	The decrease in lung resistance tended to be more pronounced after albuterol administration with Device 1 ( P = 0.066 ) .\
CONCLUSIONS	Aerosolised albuterol is an effective bronchodilator in horses with recurrent airway obstruction .\
CONCLUSIONS	There is no statistically significant difference between the 2 commercially available aerosol delivery devices in terms of efficacy .\
CONCLUSIONS	Aerosolised albuterol is effectively delivered using currently available devices leading to maximal bronchodilation in horses with RAO at an average dose of 540 g.\
\
###12119249\
BACKGROUND	Data from studies of angiotensin-converting enzyme inhibitors provide evidence that the renin-angiotensin-aldosterone system plays a role as a mediator of atrial remodeling in atrial fibrillation .\
BACKGROUND	The present study has evaluated the effect of treatment with the angiotensin I type 1 receptor blocker irbesartan on maintaining sinus rhythm after conversion from persistent atrial fibrillation .\
RESULTS	To be included in the present study , patients must have had an episode of persistent atrial fibrillation for > 7 days .\
RESULTS	The patients were then randomized and scheduled for electrical cardioversion .\
RESULTS	Two groups of patients were compared : Group I was treated with amiodarone , and group II was treated with amiodarone plus irbesartan .\
RESULTS	The primary end point was the length of time to a first recurrence of atrial fibrillation .\
RESULTS	From a total of 186 patients assessed in the study , 154 were analyzed with the use of intention-to-treat analysis .\
RESULTS	Seventy-five patients were randomly allocated to group I and 79 to group II .\
RESULTS	After 2 months of follow-up in the intention-to-treat analysis , the group treated with irbesartan had fewer patients with recurrent atrial fibrillation ( Kaplan-Meier analysis , 84.79 % versus 63.16 % , P = 0.008 ) .\
RESULTS	The Kaplan-Meier analysis of time to first recurrence during the follow-up period ( median time , 254 days [ range , 60 to 710 ] ) also showed that patients treated with irbesartan had a greater probability of remaining free of atrial fibrillation ( 79.52 % versus 55.91 % , P = 0.007 ) .\
CONCLUSIONS	Patients treated with amiodarone plus irbesartan had a lower rate of recurrence of atrial fibrillation than did patients treated with amiodarone alone .\
\
###19906163\
OBJECTIVE	To determine the safety and efficacy of photodynamic therapy ( PDT ) with topical application of 20 % wt/vol aminolevulinic acid hydrochloride ( ALA ) in the treatment of condylomata acuminata ( CA ) .\
METHODS	Patients with CA were randomly allocated into the ALA-PDT group and the CO ( 2 ) laser group in an allocation ratio of 3 : 1 .\
METHODS	The treatment was repeated weekly if necessary , but no more than 3 times .\
METHODS	The primary efficacy endpoint was the wart clearance rate 1 week after the last treatment .\
METHODS	The recurrence rate was evaluated at weeks 4 , 8 and 12 after the treatment ended .\
METHODS	The clinical response to therapy and adverse effects were recorded .\
RESULTS	A total of 91 patients with CA were enrolled in the clinical trial .\
RESULTS	Of these 90 ( 98.9 % ) patients completed the trial ( 67 in the ALA-PDT group , and 23 in CO ( 2 ) laser group ) .\
RESULTS	By 1 week after the last treatment , the complete clearance rate was 95.93 % in the ALA-PDT group and 100 % in CO ( 2 ) laser group ( P > 0.05 ) .\
RESULTS	The clearance rate of CA at male urethral orifice was 100 % in the ALA-PDT group and 100 % in the CO ( 2 ) laser group ( P > 0.05 ) .\
RESULTS	The overall recurrence rate calculated by the end of the entire follow-up period was significantly lower in the ALA-PDT group than that in the CO ( 2 ) laser group ( 9.38 % vs 17.39 % , P < 0.05 ) .\
RESULTS	Moreover , there was no systemic adverse event in either group .\
RESULTS	The proportion of patients with adverse effects in the ALA-PDT group ( 8.82 % ) was also significantly lower than that in the CO ( 2 ) laser group ( 100 % , P < 0.05 ) .\
RESULTS	The side-effects in patients treated with ALA-PDT mainly included mild burning and/or stinging restricted to the illuminated area .\
CONCLUSIONS	The results confirmed that topical application of ALA-PDT is a simpler and as effective therapy with a lower incidence of adverse effects in the treatment of CA compared with conventional CO ( 2 ) laser therapy .\
\
###18707870\
OBJECTIVE	PETACC-1 assessed if raltitrexed is non-inferior to 5-fluorouracil and leucovorin for relapse-free survival ( RFS ) and overall survival ( OS ) in adjuvant stage III colon cancer .\
METHODS	Non-inferiority required both HR for RFS and OS < 1.25 at 1-sided alpha = 0.05 .\
METHODS	Patients ( 1921 ) were randomised to six cycles of 5-FU/LV ( n = 969 ) or eight cycles of raltitrexed ( n = 952 ) .\
METHODS	We report the final results in 993 eligible patients who started and completed the allocated treatment ( 489 5-FU/LV and n = 504 Raltitrexed ) of whom respectively 146 and 148 died , respectively .\
RESULTS	The trial closed prematurely when 17 ( 1.9 % ) raltitrexed-related deaths were reported .\
RESULTS	Haematological and gastrointestinal toxicities were more frequent with 5-FU/LV , liver toxicities with raltitrexed .\
RESULTS	Raltitrexed was stopped for toxicity in 13.2 % and 5-FU/LV in 8.5 % .\
RESULTS	Sixty-day mortality was 9 % versus 7 % .\
RESULTS	With 4.1 years median follow-up , the HR for RFS was 1.16 ( 90 % CI 0.99-1 .37 ) and that for OS was 1.01 ( 90 % CI 0.84-1 .23 ) .\
CONCLUSIONS	The trial failed to demonstrate non-inferiority of raltitrexed .\
BACKGROUND	Free drugs and financial support from AstraZeneca .\
\
###16480472\
BACKGROUND	Subarachnoid blockade with local anesthetics induces respiratory depression .\
BACKGROUND	Although the addition of fentanyl to bupivacaine has become popular in subarachnoid blockade for Cesarean section , there is no information on the effect of intrathecal fentanyl on maternal spirometric respiratory function in parturients undergoing Cesarean section .\
METHODS	We tested the effect of the addition of intrathecal fentanyl to hyperbaric bupivacaine on maternal spirometric performance in 40 consenting parturients undergoing Cesarean section .\
METHODS	The parturients were randomized into two groups : those receiving 2.0 ml of hyperbaric bupivacaine 0.5 % and 0.4 ml of saline intrathecally and those receiving 2.0 ml of hyperbaric bupivacaine and 0.4 ml of fentanyl ( 20 microg ) intrathecally .\
METHODS	We performed spirometry on arriving at the operation room and 15 min after subarachnoid blockade .\
RESULTS	Subarachnoid blockade with bupivacaine significantly decreased the peak expiratory flow rate , but did not induce significant changes in vital capacity and forced vital capacity .\
RESULTS	The addition of intrathecal fentanyl to bupivacaine improved the quality of subarachnoid blockade , but did not lead to a deterioration in respiratory function compared with intrathecal bupivacaine alone .\
CONCLUSIONS	The addition of intrathecal fentanyl to hyperbaric bupivacaine did not lead to a deterioration in maternal spirometric respiratory function in parturients undergoing Cesarean section .\
\
###20511481\
OBJECTIVE	To assess maintenance of efficacy and tolerability of gabapentin enacarbil in patients with moderate to severe primary restless legs syndrome ( RLS ) .\
METHODS	This study ( conducted April 18 , 2006 , to November 14 , 2007 ) comprised a 24-week , single-blind ( SB ) treatment phase ( gabapentin enacarbil , 1200 mg ) followed by a 12-week randomized , double-blind ( DB ) phase .\
METHODS	Responders from the SB phase ( patients with improvements on the International Restless Legs Scale [ IRLS ] and investigator-rated Clinical Global Impression-Improvement scale at week 24 and stable while taking a gabapentin enacarbil dose of 1200 mg for at least 1 month before randomization ) were randomized to gabapentin enacarbil , 1200 mg , or placebo once daily at 5 pm with food .\
METHODS	The primary end point was the proportion of patients experiencing relapse ( worse scores on the IRLS and investigator-rated Clinical Global Impression of Change scale on 2 consecutive visits at least 1 week apart or withdrawal because of lack of efficacy ) during the DB phase .\
RESULTS	A total of 221 of 327 patients completed the SB phase , 194 ( 96 in the gabapentin enacarbil group and 98 in the placebo group ) were randomized to DB treatment , and 168 ( 84 in the gabapentin enacarbil group and 84 in the placebo group ) completed the DB phase .\
RESULTS	A significantly smaller proportion of patients treated with gabapentin enacarbil ( 9/96 [ 9 % ] ) experienced relapse compared with the placebo-treated patients ( 22/97 [ 23 % ] ) ( odds ratio , 0.353 ; 95 % confidence interval , 0.2-0 .8 ; P = .02 ) .\
RESULTS	Somnolence and dizziness were the most common adverse events .\
RESULTS	One death occurred ( unintentional choking during the SB phase ) and was judged as being unrelated to the study drug .\
RESULTS	No clinically relevant changes were observed in laboratory values , in vital signs , or on electrocardiograms .\
CONCLUSIONS	Gabapentin enacarbil , 1200 mg , maintained improvements in RLS symptoms compared with placebo and showed long-term tolerability in adults with moderate to severe primary RLS for up to 9 months of treatment .\
\
###23225838\
OBJECTIVE	To observe the efficacy of the combined treatment of carbamazepine and botulinum toxin A for blepharospasm and hemifacial spasm .\
METHODS	Fifty-eight patients with either blepharospasm or hemifacial spasm were randomly divided into treatment and control groups .\
METHODS	In the treatment group , 30 patients were administered with local intramuscular injections of botulinum toxin A and oral carbamazepine 100 mg/time , 3 times a day for 60 days .\
METHODS	Twenty-eight subjects in the control group underwent local intramuscular injections of botulinum toxin A only .\
RESULTS	After combined treatment , the complete remission rate was 90 % , which was significantly higher than that of the of the control group ( 67.9 % , P < 0.05 , X2 = 4.733 ) .\
RESULTS	However , no statistical significance was noted regarding the duration of therapeutic effects between the treatment group ( range 14 ~ 40 weeks ; 19.2 weeks on average ) and control group ( range 12 ~ 36 weeks ; 18 weeks on average ) .\
CONCLUSIONS	The combined therapy of carbamazepine and topical injections of botulinum toxin A had increased efficacy in the treatment of blepharospasm or hemifacial spasm , but had no significant effect in terms of the duration of the therapeutic effect .\
\
###9727569\
OBJECTIVE	The dynamics uf viral decline following the initiation of antiretroviral treatment were studied in 29 HIV-1-infected patients participating in a two-arm trial comparing immediate ( group A : ritonavir , zidovudine and lamivudine ) and delayed ( group B : ritonavir supplemented by zidovudine and lamivudine on day 21 ) triple therapy .\
OBJECTIVE	Parameters underlying viral dynamics were estimated using mathematical models tailored to these treatment protocols .\
RESULTS	The decline in plasma HIV-1 density between day 0 and 21 was steeper in group A ( -2.27 + / - 0.46 log10 ) than group B ( -1.87 + / -0.56 log10 ) .\
RESULTS	In a subset of patients amenable to full mathematical analysis , a short-lived productively infected cell compartment ( producing approximately 97 % of total virions ) decayed with a half-life of 1.0-2 .5 days , whereas a long-lived infected cell compartment decayed with a half-life of 18.8-32 .8 days .\
RESULTS	Estimates for the time for the elimination of virus from these two cell populations ranged from 474 to 802 days .\
RESULTS	The rate of loss of productively infected CD4 + T cells was positively correlated with baseline viral load in group A and in the combined dataset .\
CONCLUSIONS	These results suggest that HIV-infected cell populations may have a faster turnover in patients with higher viral loads due to higher infection rate parameters , higher rates of virus production , or lower virus clearance rates .\
\
###23672972\
OBJECTIVE	To study the effect of bicanalicular silicone intubation on endonasal endoscopic mechanical dacryocystorhinostomy ( EEM-DCR ) for primary acquired nasolacrimal duct obstruction ( PANDO ) .\
METHODS	Randomized clinical trial .\
METHODS	A total of 120 consecutive adults ( 103 females ) with a presenting age of 64 13.7 years ( range , 39-92 years ) underwent EEM-DCR for PANDO from November 2005 to May 2009 in a lacrimal referral center .\
METHODS	The EEM-DCR was performed by 2 lacrimal surgeons using standard techniques .\
METHODS	Patients were randomly assigned to receive or not receive bicanalicular silicone intubation for 8 weeks .\
METHODS	No antimetabolite was used .\
METHODS	All patients received a course of oral antibiotics during nonabsorbable nasal packing for flaps tamponade , which was removed at the first postoperative visit .\
METHODS	Patients were assessed at 1 , 3 , 6 , 12 , 26 , and 52 weeks after the operation .\
METHODS	Surgical success was defined by symptomatic relief of epiphora , reestablishment of nasolacrimal drainage confirmed by irrigation by 1 masked observer , and positive functional endoscopic dye test by the operative surgeon at 12 months postoperatively .\
METHODS	Intraoperative and postoperative complications were recorded .\
RESULTS	A total of 118 of the 120 randomized cases completed 12 months of follow-up .\
RESULTS	Two patients died of unrelated medical illnesses during follow-up .\
RESULTS	At 12 months postoperatively , there was no statistical difference in the success rate between patients with ( 96.3 % ) and without ( 95.3 % ) intubation ( P = 0.79 ) .\
RESULTS	The odds ratio of failure without silicone intubation was 1.28 ( 95 % confidence interval , 0.21-7 .95 ) .\
RESULTS	There was no difference in the incidence ( P = 0.97 ) or the time to develop ( P = 0.12 ) granulation tissue between the 2 groups .\
RESULTS	No significant difference was found between successful and failed cases in terms of age ( P = 0.21 ) , sex ( P = 0.37 ) , laterality ( P = 0.46 ) , mode of anesthesia ( P = 0.14 ) , surgeon ( P = 0.26 ) , use of stent ( P = 0.79 ) , or presence of granulation tissue postoperatively ( P = 0.39 ) .\
CONCLUSIONS	The current study design provided 90 % statistical power to detect more than 21 % difference in surgical outcome , and no such difference was found whether intubation was used or not used in EEM-DCR for PANDO at the 12-month follow-up .\
BACKGROUND	The author ( s ) have no proprietary or commercial interest in any materials discussed in this article .\
\
###11250628\
OBJECTIVE	This study 's objective was to develop a Visual Analogue Scale ( VAS ) xerostomia questionnaire and to evaluate the validity and reliability for the clinical diagnosis of salivary gland dysfunction .\
METHODS	Thirty-six healthy adults participated in this double-blind , crossover study .\
METHODS	Each subject received an antisialagogue ( glycopyrrolate ) or placebo .\
METHODS	Unstimulated and stimulated parotid and submandibular saliva samples were collected 16 times over a period of 6 hours .\
METHODS	An 8-item VAS xerostomia questionnaire was administered after each saliva collection .\
RESULTS	The results demonstrated significant reliability for 7 of the 8 VAS items , whereas validity was significant for unstimulated submandibular saliva .\
RESULTS	Moving averages were calculated for VAS and salivary flow rate values , and significant correlations were observed between these factors , indicating that changes in VAS responses were predictive of changes in salivary flow .\
CONCLUSIONS	These findings suggest that this VAS xerostomia questionnaire may be helpful in the diagnosis of salivary dysfunction and for detecting changes in salivary flow rate values over time .\
\
###17116766\
BACKGROUND	Rivaroxaban ( BAY 59-7939 ) -- an oral , direct Factor Xa inhibitor -- could be an alternative to heparins and warfarin for the prevention and treatment of thromboembolic disorders .\
RESULTS	This randomized , double-blind , double-dummy , active-comparator-controlled , multinational , dose-ranging study assessed the efficacy and safety of once-daily rivaroxaban relative to enoxaparin for prevention of venous thromboembolism in patients undergoing elective total hip replacement .\
RESULTS	Patients ( n = 873 ) were randomized to once-daily oral rivaroxaban doses of 5 , 10 , 20 , 30 , or 40 mg ( initiated 6 to 8 hours after surgery ) or a once-daily subcutaneous enoxaparin dose of 40 mg ( given the evening before and > or = 6 hours after surgery ) .\
RESULTS	Study drugs were continued for an additional 5 to 9 days ; mandatory bilateral venography was performed the following day .\
RESULTS	The primary end point ( composite of any deep vein thrombosis , objectively confirmed pulmonary embolism , and all-cause mortality ) was observed in 14.9 % , 10.6 % , 8.5 % , 13.5 % , 6.4 % , and 25.2 % of patients receiving 5 , 10 , 20 , 30 , and 40 mg rivaroxaban , and 40 mg enoxaparin , respectively ( n = 618 , per-protocol population ) .\
RESULTS	No significant dose-response relationship was found for efficacy ( P = 0.0852 ) .\
RESULTS	Major postoperative bleeding was observed in 2.3 % , 0.7 % , 4.3 % , 4.9 % , 5.1 % , and 1.9 % of patients receiving 5 , 10 , 20 , 30 , and 40 mg rivaroxaban , and 40 mg enoxaparin , respectively ( n = 845 , safety population ) , representing a significant dose-response relationship ( P = 0.0391 ) .\
CONCLUSIONS	Rivaroxaban showed efficacy and safety similar to enoxaparin for thromboprophylaxis after total hip replacement , with the convenience of once-daily oral dosing and without the need for coagulation monitoring .\
CONCLUSIONS	When both efficacy and safety are considered , these results suggest that 10 mg rivaroxaban once daily should be investigated in phase III studies .\
\
###16612708\
BACKGROUND	The myometrial hyperactivity and reduced uterine blood flow of primary dysmenorrhea is to a large extent caused by increased vasopressin secretion .\
BACKGROUND	A new therapeutic approach for this condition is to develop antagonists of uterine vasopressin V1a receptors .\
BACKGROUND	We studied a test model of vasopressin-induced dysmenorrhea in healthy , sterilized women and compared responses against those in dysmenorrheic subjects .\
METHODS	Eight women with primary dysmenorrhea and eight sterilized , healthy women participated in recordings of intrauterine pressure and experienced pain on days 1-2 of two menstruations .\
METHODS	We tried to identify biochemical markers in plasma of uterine ischemia .\
METHODS	Furthermore , the effects of repeated bolus injections of 10 pmol/kg b w of vasopressin or placebo on these parameters were assessed .\
RESULTS	The vasopressin injections caused statistically significant increases in the area under the intrauterine pressure curve ( AUC ) in both healthy volunteers and patients with dysmenorrhea , the overall responses being greater in healthy volunteers .\
RESULTS	The experienced pain measured by visual analog scale in individual dysmenorrheic subjects tended to show higher maximal post-dose scores for the vasopressin injections than for placebo .\
RESULTS	Maximum visual analog scale scores and maximum AUCs in individual subjects tended to be related .\
RESULTS	Mean creatine kinase MB levels were higher in women with dysmenorrhea than in healthy subjects both before and after vasopressin administration , the converse being observed for C-reactive protein levels .\
CONCLUSIONS	The present model appears to be useful for evaluating new drugs for the treatment of primary dysmenorrhea .\
\
###21715530\
BACKGROUND	3,4-Methylenedioxymethamphetamine ( MDMA , ecstasy ) misuse is associated with hyponatremia particularly in women .\
BACKGROUND	Hyponatremia is possibly due to inappropriate secretion of plasma arginine vasopressin ( AVP ) .\
OBJECTIVE	To assess whether MDMA increases plasma AVP and copeptin in healthy male and female subjects and whether effects depend on MDMA-induced release of serotonin and norepinephrine .\
OBJECTIVE	Copeptin , the C-terminal part of the AVP precursor preprovasopressin , is cosecreted with AVP and can be determined more reliably .\
METHODS	We used a randomized placebo-controlled crossover design .\
METHODS	Plasma and urine osmolalities as well as AVP and copeptin levels were measured in 16 healthy subjects ( eight female , eight male ) at baseline and after MDMA ( 125 mg ) administration .\
METHODS	In addition , we tested whether effects of MDMA on AVP and copeptin secretion can be prevented by pretreatment with the serotonin and norepinephrine transporter inhibitor duloxetine ( 120 mg ) , which blocks MDMA-induced transporter-mediated release of serotonin and norepinephrine .\
RESULTS	MDMA significantly elevated plasma copeptin levels at 60 min and at 120 min compared with placebo in women but not in men .\
RESULTS	The copeptin response to MDMA in women was prevented by duloxetine .\
RESULTS	MDMA also nonsignificantly increased plasma AVP levels in women , and the effect was prevented by duloxetine .\
RESULTS	Although subjects drank more water after MDMA compared with placebo administration , MDMA tended to increase urine sodium levels and urine osmolality compared with placebo , indicating increased renal water retention .\
CONCLUSIONS	MDMA increased plasma copeptin , a marker for AVP secretion , in women but not in men .\
CONCLUSIONS	This sex difference in MDMA-induced AVP secretion may explain why hyponatremia is typically reported in female ecstasy users .\
CONCLUSIONS	The copeptin response to MDMA is likely mediated via MDMA-induced release of serotonin and/or norepinephrine because it was prevented by duloxetine , which blocks the interaction of MDMA with the serotonergic and noradrenergic system .\
\
###15917042\
BACKGROUND	This study reports the effect of providing Norwegian school children with free fruit or vegetables every school day and the effect of an existing fee-based School Fruit Programme .\
METHODS	Seventh grade pupils and their parents completed questionnaires at baseline ( autumn 2001 ) and at follow-up ( spring 2002 ) .\
METHODS	Nine schools participated in the School Fruit Programme for free ( Free fruit ) , nine schools took part at standard conditions ( Paid fruit ) , and 20 schools did not take part in the subscription programme ( No fruit ) .\
METHODS	A total of 795 7th graders ( 11 or 12 years old at baseline ) participated both at baseline and at follow-up .\
RESULTS	At follow-up , pupils attending the Free fruit schools had significantly higher intake of fruit and vegetables at school than the pupils at the Paid fruit and No fruit schools ( P < 0.001 , mean intakes were 1.1 , 0.4 and 0.2 portions , respectively ) .\
RESULTS	Subscribers at the Paid fruit schools had significantly higher intake than the non-subscribers at the same schools .\
CONCLUSIONS	Providing a free piece of fruit or a vegetable is an effective strategy to increase school children 's fruit and vegetable intake .\
CONCLUSIONS	The existing School Fruit Programme appears to increase the intake among the subscribers , but thereby also tends to increase an existing difference in consumption patterns among subscribers and non-subscribers .\
\
###22989894\
BACKGROUND	Maternal , Newborn , and Child Health ( MNCH ) household survey data are collected mainly with pen-and-paper .\
BACKGROUND	Smartphone data collection may have advantages over pen-and-paper , but little evidence exists on how they compare .\
OBJECTIVE	To compare smartphone data collection versus the use of pen-and-paper for infant feeding practices of the MNCH household survey .\
OBJECTIVE	We compared the two data collection methods for differences in data quality ( data recording , data entry , open-ended answers , and interrater reliability ) , time consumption , costs , interviewers ' perceptions , and problems encountered .\
METHODS	We recruited mothers of infants aged 0 to 23 months in four village clinics in Zhaozhou Township , Zhao County , Hebei Province , China .\
METHODS	We randomly assigned mothers to a smartphone or a pen-and-paper questionnaire group .\
METHODS	A pair of interviewers simultaneously questioned mothers on infant feeding practices , each using the same method ( either smartphone or pen-and-paper ) .\
RESULTS	We enrolled 120 mothers , and all completed the study .\
RESULTS	Data recording errors were prevented in the smartphone questionnaire .\
RESULTS	In the 120 pen-and-paper questionnaires ( 60 mothers ) , we found 192 data recording errors in 55 questionnaires .\
RESULTS	There was no significant difference in recording variation between the groups for the questionnaire pairs ( P = .32 ) or variables ( P = .45 ) .\
RESULTS	The smartphone questionnaires were automatically uploaded and no data entry errors occurred .\
RESULTS	We found that even after double data entry of the pen-and-paper questionnaires , 65.0 % ( 78/120 ) of the questionnaires did not match and needed to be checked .\
RESULTS	The mean duration of an interview was 10.22 ( SD 2.17 ) minutes for the smartphone method and 10.83 ( SD 2.94 ) minutes for the pen-and-paper method , which was not significantly different between the methods ( P = .19 ) .\
RESULTS	The mean costs per questionnaire were higher for the smartphone questionnaire ( 143 , equal to US $ 23 at the exchange rate on April 24 , 2012 ) than for the pen-and-paper questionnaire ( 83 , equal to US $ 13 ) .\
RESULTS	The smartphone method was acceptable to interviewers , and after a pilot test we encountered only minor problems ( eg , the system halted for a few seconds or it shut off ) , which did not result in data loss .\
CONCLUSIONS	This is the first study showing that smartphones can be successfully used for household data collection on infant feeding in rural China .\
CONCLUSIONS	Using smartphones for data collection , compared with pen-and-paper , eliminated data recording and entry errors , had similar interrater reliability , and took an equal amount of time per interview .\
CONCLUSIONS	While the costs for the smartphone method were higher than the pen-and-paper method in our small-scale survey , the costs for both methods would be similar for a large-scale survey .\
CONCLUSIONS	Smartphone data collection should be further evaluated for other surveys and on a larger scale to deliver maximum benefits in China and elsewhere .\
\
###15992524\
BACKGROUND	Second-generation antipsychotics ( SGAs ) differ from first-generation antipsychotics ( FGAs ) with respect to induction of less extrapyramidal morbidity , partially reducing negative symptoms , and causing modest improvement in neurocognitive functioning in patients with schizophrenia .\
BACKGROUND	SGAs demonstrate 5-HT2a antagonism .\
BACKGROUND	Differential effects of SGAs and FGAs on cortical gray volumes are explored herein .\
METHODS	Cerebral cortical gray was examined volumetrically in 19 patients with schizophrenia before and following 28 days of treatment with two SGAs ( risperidone and ziprasidone ; n = 13 ) or a FGA ( haloperidol ; n = 6 ) .\
METHODS	Seven ( untreated ) control subjects were also assessed at a similar interval .\
RESULTS	During treatment with the SGAs risperidone and ziprasidone , cerebral cortical gray of 13 patients with schizophrenia expanded 20.6 + / - 11.4 cc ( p < .0005 ) .\
RESULTS	Six patients receiving the FGA haloperidol , as well as 7 control subjects , showed no change in cortical gray volumes ( p = .983 and p = .932 , respectively ) at the time of reassessment .\
CONCLUSIONS	Volumetric increase of cerebral cortical gray occurred early in the course of treatment with the SGAs ziprasidone and risperidone , but not with the FGA haloperidol .\
CONCLUSIONS	Such cortical gray expansion may be relevant to the reported enhanced neurocognition and quality of life associated with SGA treatment .\
\
###16234460\
OBJECTIVE	Owing to the complex topographical aspects of ophthalmic surgery , teaching with conventional surgical videos has led to a poor understanding among medical students .\
OBJECTIVE	A novel multimedia three dimensional ( 3D ) computer animated program , called `` Ophthalmic Operation Vienna '' has been developed , where surgical videos are accompanied by 3D animated sequences of all surgical steps for five operations .\
OBJECTIVE	The aim of the study was to assess the effect of 3D animations on the understanding of cataract and glaucoma surgery among medical students .\
METHODS	Set in the Medical University of Vienna , Department of Ophthalmology , 172 students were randomised into two groups : a 3D group ( n = 90 ) , that saw the 3D animations and video sequences , and a control group ( n = 82 ) , that saw only the surgical videos .\
METHODS	The narrated text was identical for both groups .\
METHODS	After the presentation , students were questioned and tested using multiple choice questions .\
RESULTS	Students in the 3D group found the interactive multimedia teaching methods to be a valuable supplement to the conventional surgical videos .\
RESULTS	The 3D group outperformed the control group not only in topographical understanding by 16 % ( p < 0.0001 ) , but also in theoretical understanding by 7 % ( p < 0.003 ) .\
RESULTS	Women in the 3D group gained most by 19 % over the control group ( p < 0.0001 ) .\
CONCLUSIONS	The use of 3D animations lead to a better understanding of difficult surgical topics among medical students , especially for female users .\
CONCLUSIONS	Gender related benefits of using multimedia should be further explored .\
\
###16980507\
BACKGROUND	Levonorgestrel ( LNG ) consistently prevents follicular rupture only when it is given before the onset of the ovulatory stimulus .\
BACKGROUND	As locally synthesized prostaglandin ( PG ) plays a crucial role in follicular rupture and cyclooxygenase-2 ( cox-2 ) catalyses the final step of PG synthesis , we reasoned that adding a cox-2 inhibitor to LNG would prevent follicular rupture even after the ovulatory process had been triggered by the gonadotrophin surge .\
METHODS	Forty-one women were divided into two groups .\
METHODS	One was treated when the size of the leading follicle was 15-17 mm ( n = 10 ) and the other when it was > or = 18 mm ( n = 31 ) .\
METHODS	Each woman contributed with one cycle treated with LNG 1.5 mg single dose plus placebo and another treated with LNG + meloxicam ( Melox ) 15 mg , in a randomized order .\
METHODS	Serial blood sampling for the assay of LH and follicular monitoring by transvaginal ultrasound were performed before and after treatment .\
RESULTS	Follicular rupture failed to occur within the 5-day period that followed treatment in 50 and 70 % of cycles treated with LNG + Placebo and LNG + Melox , respectively , in the 15-17 mm group ( P = 0.15 ) and in 16 and 39 % of cycles treated with LNG + Placebo and LNG + Melox , respectively , in the > or = 18 mm group ( P < 0.052 ) .\
RESULTS	The overall proportion of cycles with no follicular rupture or ovulatory dysfunction increased significantly by the addition of Melox to LNG ( 66 versus 88 % , P < 0.012 ; n = 41-matched pairs ) .\
CONCLUSIONS	The trend towards increased incidence of no follicular rupture when Melox was combined with LNG suggests that the addition of a cox-2 inhibitor has the potential to improve the contraceptive efficacy of LNG by a pre-fertilization effect .\
\
###19083502\
BACKGROUND	A high concentration of crosslinked hyaluronic acid ( HA ) in a smooth , malleable formulation is the hallmark of the new Juvderm dermal fillers .\
OBJECTIVE	To determine the long-term effectiveness and safety of Juvderm Ultra and Ultra Plus injectable gel .\
METHODS	In the multicenter study approved by the Food and Drug Administration , subjects were randomized to treatment with Juvderm Ultra or Ultra Plus in one nasolabial fold ( NLF ) and Zyplast collagen in the other .\
METHODS	After optimal correction was achieved ( treatment plus up to 2 touch-ups at 2-week intervals ) , effectiveness was assessed on a 5-point scale through the 6-month study period .\
METHODS	An additional poststudy visit provided long-term effectiveness data .\
METHODS	Safety was evaluated through subjects ' daily diaries for 14 days after treatment .\
RESULTS	A total of 292 subjects were randomized and treated , 146 in each cohort .\
RESULTS	A total of 280 subjects completed the 6-month study , and 227 attended the poststudy visit .\
RESULTS	Clinically significant mean wrinkle correction ( > or = 1 point improvement ) was still in evidence at > 9 months for both Juvderm formulations but not for the Zyplast control .\
RESULTS	At > 9 months , 75 % of Juvderm Ultra - and 81 % of Juvderm Ultra Plus-treated NLFs maintained a clinically significant correction .\
RESULTS	Moreover , 78 % of NLFs treated with Juvderm Ultra Plus still had a clinically significant improvement beyond 1 year .\
RESULTS	Local treatment site reactions were comparable for Juvderm and Zyplast .\
CONCLUSIONS	These next-generation HA dermal fillers can be reliably expected to provide long-term correction , with Juvderm Ultra lasting more than 9 months and Juvderm Ultra Plus lasting for a year or more .\
\
###24402336\
OBJECTIVE	this study aimed to evaluate the efficacy of hand hygiene performed with two different soap formulations : 0.3 % Melaleuca alternifolia essential oil versus 0.5 % triclosan , and to compare them with two reference hygiene procedures : the official methodology procedure ( soft soap ) versus the draft version of the procedure ( soft soap + propan-2-ol ) .\
METHODS	using the European EN 1499 method , logarithmic reduction factors were determined for the number of colony forming units of Escherichia coli K12 before and after hand hygiene of 15 volunteer subjects , and compared using the one-tailed Wilcoxon test .\
RESULTS	referring to the soft soap , there was no difference between the performance of soap with 0.3 % M. alternifolia and soap containing 0.5 % triclosan .\
RESULTS	The soft soap + propan-2-ol proved to be more effective than the other hand hygiene procedures .\
CONCLUSIONS	studies to verify the therapeutic efficacy of essential oil in hand hygiene can improve adherence to this practice .\
\
###23381501\
OBJECTIVE	Our aim was to evaluate the efficacy of our treatment program for children with lower urinary tract conditions , developed at the Department of Pediatric Nephrology of the University Children 's Hospital in Ljubljana .\
METHODS	Sixty-four patients with lower urinary tract conditions were randomly allocated to two groups .\
METHODS	Group A received treatment immediately , whereas patients of group B received no treatment for a period of 3 months-the amount of time it takes to complete our program .\
METHODS	No child in group B experienced spontaneous regression of their symptoms in the 3-month delay period , while the patients of group A were already being treated and were achieving results .\
METHODS	Thus , all the patients of group B then entered the program in exactly the same way as patients of group A.\
RESULTS	The final success rate in both groups did not differ significantly ( p = 0.706-1 .000 ) and ranged from 86.2 % for group A and 86.7 to 90 % for group B. Long-term follow-up showed statistically identical success rates ( p = 1.000 ) .\
CONCLUSIONS	This prospective controlled study with long-term follow-up ( 48 months ) shows that our treatment program , applied as an inpatient voiding school program , is an effective method , with durable results .\
\
###21300298\
BACKGROUND	The aims of this study were to evaluate tricuspid annular plane systolic excursion ( TAPSE ) as a predictor of left ventricular ( LV ) reverse remodeling and clinical benefit of cardiac synchronization therapy ( CRT ) and to evaluate the effect of CRT on TAPSE in patients with mildly symptomatic systolic heart failure as a substudy of the REsyncronization reVErses Remodeling in Systolic left vEntricular dysfunction ( REVERSE ) trial .\
RESULTS	Patients ( n = 450 ) were randomized in a 2:1 fashion to CRT ON or CRT OFF and followed for 12 months .\
RESULTS	End points were reverse LV remodeling defined as a reduction in LV end-systolic volume of 20 mL/m ( 2 ) by echocardiography and a clinical composite score , defined as freedom from clinical deterioration .\
RESULTS	TAPSE was an independent predictor of reverse remodeling , OR = 1.08 ( 95 % CI 1.03-1 .14 ) per mm increase and a favorable clinical composite score , OR = 1.08 ( 95 % CI 1.02-1 .14 ) .\
RESULTS	No significant interactions were observed between TAPSE and CRT ON .\
RESULTS	CRT ON was not associated with a significant effect on TAPSE compared to CRT OFF , -0.8 4.7 vs. 0.3 5 mm , P = .06 .\
CONCLUSIONS	TAPSE is an independent predictor of clinical response and improved reverse remodeling in patients with mildly symptomatic heart failure .\
CONCLUSIONS	The effect of CRT is not modified by TAPSE in the present population .\
CONCLUSIONS	CRT is not associated with a clinically significant effect on TAPSE .\
\
###25244402\
OBJECTIVE	To evaluate the efficacy and safety of gatifloxacin 0.5 % ophthalmic solution administered twice daily for treatment of acute bacterial conjunctivitis .\
METHODS	Two identically designed , double-masked , multicenter studies in the United States and India enrolled patients 1 year or older with acute bacterial conjunctivitis .\
METHODS	Patients were randomized to gatifloxacin 0.5 % or vehicle treatment for 5 days .\
METHODS	Clinical success in clearing conjunctival hyperemia and discharge at day 6 ( primary endpoint ) and day 4 and microbiological cure were determined .\
METHODS	Isolates from positive conjunctival samples were tested for sensitivity and susceptibility .\
METHODS	Safety measures included adverse events ( AEs ) .\
METHODS	Data from these 2 studies were pooled for these analyses .\
RESULTS	Of the 1437 randomized patients , 658 constituted the modified intent-to-treat population .\
RESULTS	Patient characteristics were similar between the pooled treatment groups .\
RESULTS	Clinical success occurred for 58.0 % of gatifloxacin 0.5 % - treated versus 45.5 % vehicle-treated patients at day 6 ( P = 0.001 ) and for 23.7 % versus 15.4 % in the respective groups at day 4 ( P = 0.007 ) .\
RESULTS	Microbiological cure was higher with gatifloxacin 0.5 % than vehicle at days 4 and 6 ( P < 0.001 for both time points ) .\
RESULTS	The combined minimum inhibitory concentration required to inhibit 90 % of isolates for gatifloxacin 0.5 % was 2.0 g/mL for gram-positive and gram-negative organisms .\
RESULTS	AEs were reported by 11.6 % and 13.3 % of patients in the gatifloxacin 0.5 % and vehicle safety populations , respectively .\
RESULTS	One patient in each treatment group experienced a serious AE ; neither was treatment related .\
CONCLUSIONS	The 0.5 % concentration of gatifloxacin ophthalmic solution was safe and effective for treatment of acute bacterial conjunctivitis with twice-daily administration for 5 days .\
\
###11444269\
OBJECTIVE	The aim of this study was to investigate the effectiveness of acitretin in a new topical formulation ( mucoadhesive two-layer tablets ) for the treatment of oral leucoplakias .\
METHODS	Twenty-one volunteers , 16 men , five women , with oral leucoplakia ( histologically diagnosed ) , were included in this double-blind placebo-controlled study .\
METHODS	Patients were randomized in three groups ( A , B , C ) of seven patients each .\
METHODS	Groups A and B received tablets with different in vitro release profiles , and group C subjects ( controls ) received tablets without acitretin .\
METHODS	The acitretin dose was 20 mg/day ( two 10 mg tablets daily ) .\
METHODS	Serum aspartate aminotransferase , alanine aminotransferase , cholesterol and triglycerides were evaluated before and after treatment .\
METHODS	At the end of therapy the concentrations of acitretin in plasma , saliva and tissue were measured by high-performance liquid chromatography .\
RESULTS	At the end of the study 71 % ( groups A and B ) of patients showed clinical remission or marked improvement .\
RESULTS	No improvement was noted in the control subjects ( group C ) .\
RESULTS	These results were further confirmed by histological findings .\
RESULTS	There were no significant changes in laboratory values in the three groups .\
RESULTS	The acitretin concentration in plasma and tissue ranged from 0 to 50 mg with no difference between groups A and B , and it was very high in saliva ( ranging from 4.9 to 43 mg ) with higher concentrations in group A than in group B ( due to a longer adhesion time in group A ) .\
RESULTS	Patients ' compliance was excellent .\
RESULTS	The results show that mucoadhesive tablets of topical acitretin are efficacious in the treatment of oral leucoplakia without systemic side-effects .\
\
###19686525\
OBJECTIVE	Evaluation of the efficacy and safety of slow-release oral morphine ( SROM ) compared with methadone for detoxification from methadone and SROM maintenance treatment .\
METHODS	Randomized , double-blind , double-dummy , comparative multi-centre study with parallel groups .\
METHODS	Three psychiatric hospitals in Austria specializing in in-patient detoxification .\
METHODS	Male and female opioid dependents ( age > 18 years ) willing to undergo detoxification from maintenance therapy in order to reach abstinence .\
METHODS	Abstinence was reached from maintenance treatment by tapered dose reduction of either SROM or methadone over a period of 16 days .\
METHODS	Efficacy analyses were based on the number of patients per treatment group completing the study , as well as on the control of signs and symptoms of withdrawal [ measured using Short Opioid Withdrawal Scale ( SOWS ) ] and suppression of opiate craving .\
METHODS	In addition , self-reported somatic and psychic symptoms ( measured using Symptom Checklist SCL-90-R ) were monitored .\
RESULTS	Of the 208 patients enrolled into the study , 202 were eligible for analysis ( SROM : n = 102 , methadone : n = 100 ) .\
RESULTS	Completion rates were 51 % in the SROM group and 49 % in the methadone group [ difference between groups : 2 % ; 95 % confidence interval ( CI ) : -12 % to 16 % ] .\
RESULTS	The rate of discontinuation in the study was high mainly because of patients voluntarily withdrawing from treatment .\
RESULTS	No statistically significant differences between treatment groups were found in terms of signs and symptoms of opiate withdrawal , craving for opiates or self-reported symptoms .\
RESULTS	SROM and methadone were both well tolerated .\
CONCLUSIONS	Detoxification from maintenance treatment with tapered dose reduction of SROM is non-inferior to methadone .\
\
###14729792\
OBJECTIVE	To compare the effects of nicorandil ( a hybrid ATP sensitive potassium channel ( K + ( ATP ) channel ) opener/nitric oxide donor ) with those of isosorbide dinitrate ( ISDN ) on myocardial microcirculation and cardiac function in patients with acute myocardial infarction ( AMI ) who had undergone reperfusion treatment by direct balloon angioplasty .\
METHODS	Double blind randomised study .\
METHODS	60 patients with AMI in Killip class I.\
METHODS	Patients were assigned into two treatment groups : a nicorandil group ( n = 30 ) and an ISDN group ( n = 30 ) .\
METHODS	Each drug was infused intravenously at 6 mg/h for 72 hours starting at admission and was administered directly to the treated coronary artery immediately after angioplasty .\
RESULTS	Compared with ISDN , nicorandil more frequently caused recovery of ST segment elevation just after reperfusion ( 15 of 27 ( 55.5 % ) in the nicorandil group v 5 of 26 ( 19.2 % ) in the ISDN group , p = 0.006 ) .\
RESULTS	The nicorandil group had higher values of averaged peak velocity 40 minutes after reperfusion ( mean ( SD ) 24.8 ( 13.3 ) cm/s v 16.0 ( 11.1 ) cm/s , p = 0.045 ) and higher values of regional wall motion of the infarcted area three weeks after onset of AMI ( -1.78 ( 1.11 ) v -2.50 ( 1.04 ) SD/chord , p = 0.046 ) .\
CONCLUSIONS	A combination of nicorandil drip infusion starting before reperfusion and intracoronary injection immediately after reperfusion is more effective than a similarly performed infusion of ISDN in preserving myocardial microcirculation in the reperfused AMI area .\
CONCLUSIONS	The nicorandil regimen resulted in better left ventricular regional wall motion .\
\
###20805775\
BACKGROUND	Direct laryngoscopy along with manual inline stabilization ( MIS ) is currently the standard care for patients with suspected neck injuries .\
BACKGROUND	However , cervical collar immobilization is more commonly performed in the prehospital environment , and its early removal is necessary before intubation .\
BACKGROUND	We hypothesized that if usability of Airway Scope ( AWS ) in a difficult airway could also bring merits to intubation under cervical collar immobilization , unnecessary risk caused by the removal of a neck collar may be prevented .\
METHODS	In this crossover study , 30 consenting patients presenting for surgery were assigned to undergo intubation using AWS .\
METHODS	Neck was stabilized manually and by a neck collar in a random order before laryngoscopy was performed by the same anesthesiologist .\
METHODS	Measurements include interincisor distance ( IID ) , success rate , intubation time , and fluoroscopic examination of the upper and middle cervical spine .\
RESULTS	IID was notably narrower after application of a neck collar ( mean SE : MIS , 19 mm 1 mm ; collar , 10 mm 1 mm ; p < 0.01 ) .\
RESULTS	One and 9 failures were encountered in MIS and collar groups , respectively ( p = 0.012 ) .\
RESULTS	Intubation time proved no statistical significance .\
RESULTS	Extension of craniocervical junction was observed in both groups , but occipitoatlantal joint was significantly more extended in collar group ( median [ range ] : AWS , 10-degree angle [ -1 to 20-degree angle ] ; collar , 14-degree angle [ 5 to 26-degree angle ] ; p < 0.01 ) .\
CONCLUSIONS	AWS laryngoscopy under cervical collar immobilization fails to meet our expectation .\
CONCLUSIONS	Intubation failed in 30 % of the cases in collar group whereas only 3.3 % of the cases in MIS group .\
CONCLUSIONS	Significant difference of mouth opening limitation is probably the major reason , as 7 of 9 failed cases in collar group had IID < 10 mm .\
CONCLUSIONS	This was insufficient to insert the 18-mm blade of AWS .\
CONCLUSIONS	In addition , occipitoatlantal joint suffered a greater extension when wearing a neck collar .\
CONCLUSIONS	Differences in the method to stabilize the neck may be the reason .\
CONCLUSIONS	When compared with cervical collar immobilization , AWS laryngoscopy along with MIS seems to be a safer and more definite method to secure airway of neck-injured trauma patients because it limits less mouth opening and upper cervical spine movement .\
\
###9830233\
BACKGROUND	Alendronate sodium ( Fosamax , Merck , Sharp & Dohme , Whitehouse Station , NJ , USA ) is an aminobisphosphonate that can inhibit osteoclast-mediated bone resorption activity to reduce bone turnover rate and improve progressive gains in bone mass .\
METHODS	This was a randomized , double-blind , placebo-controlled study comparing the effects on bone turnover markers between daily treatment with alendronate sodium 10 mg and placebo .\
METHODS	Forty early postmenopausal women completed three months of treatment .\
METHODS	The bone turnover rate was determined by measuring the biochemical markers at baseline , week 6 and at the end of the three-month treatment period .\
METHODS	All adverse events were recorded during each follow-up visit .\
RESULTS	Patients receiving alendronate treatment had a significant decrease in urinary excretion of the bone resorption marker deoxypyridinoline ( Dpd ) as well as one of the bone formation markers , bone-specific alkaline phosphatase ( AlkP-B ) .\
RESULTS	Patients receiving placebo tended to have increased urinary excretion of bone resorption and formation markers .\
RESULTS	At the end of three months , the mean percentage change of Dpd and AlkP-B from baseline in the group receiving 10 mg alendronate was 30.49 % and 29.45 % reduction , respectively .\
RESULTS	The placebo group had 2.39 % and 1.52 % increase , respectively .\
RESULTS	Overall , three biochemical markers ( Dpd , AlkP-B and osteocalcin ) differed significantly between the treatment and control groups after three months of treatment .\
RESULTS	The drug was well tolerated , without a significant increase in incidence of adverse effects such as gastrointestinal discomfort and esophageal irritation .\
CONCLUSIONS	Bone turnover rate decreased quickly following drug administration .\
CONCLUSIONS	The incidence of adverse effects did not differ significantly between the alendronate and placebo groups .\
CONCLUSIONS	Alendronate is , therefore , recommended as an effective nonhormonal treatment for postmenopausal osteoporosis .\
\
###19648168\
BACKGROUND	Imatinib is the standard of care for newly diagnosed chronic-phase chronic myeloid leukemia .\
BACKGROUND	The largest randomized clinical trial of imatinib was the multinational IRIS trial in which 1106 patients were randomized to receive either imatinib 400 mg/day or a standard regimen of interferon-alpha plus cytarabine .\
METHODS	Patients were allowed to cross over to the opposite treatment for intolerance , lack of response , disease progression , and , following release of the initial efficacy data , reluctance to remain on therapy with interferon-alpha plus cytarabine .\
METHODS	The safety and efficacy of imatinib in patients who crossed over from interferon-alpha plus cytarabine to imatinib is reported here .\
RESULTS	Of 553 patients originally assigned to interferon-alpha plus cytarabine , 65 % crossed over to imatinib , of whom 67 % continue to receive treatment .\
RESULTS	After a median of 54 months of imatinib treatment on study , 93 % achieved complete hematologic remission , 86 % achieved major cytogenetic remission , and 81 % achieved a complete cytogenetic remission as the best observed response .\
RESULTS	Estimated rates of freedom from progression to accelerated or blast phase and overall survival were 91 % and 89 % , respectively , at 48 months after starting imatinib .\
CONCLUSIONS	This is the largest analysis to date describing the efficacy of imatinib in patients who have received prior therapies for chronic myeloid leukemia and it demonstrates excellent responses to this treatment .\
CONCLUSIONS	( ClinicalTrials.gov identifier : NCT00006343 ) .\
\
###22325903\
BACKGROUND	Atacicept is a soluble , fully human , recombinant fusion protein that inhibits B cell-stimulating factors APRIL ( a proliferation-inducing ligand ) and BLyS ( B-lymphocyte stimulator ) .\
BACKGROUND	The APRIL - LN study aimed to evaluate the efficacy and safety of atacicept in patients with active lupus nephritis ( LN ) , receiving newly initiated corticosteroids ( CS ) and mycophenolate mofetil ( MMF ) .\
METHODS	This was a randomized , double-blind , placebo-controlled Phase II/III , 52-week study .\
METHODS	At screening ( Day -14 ) , patients initiated high-dose CS ( the lesser of 0.8 mg/kg/day or 60 mg/day prednisone ) and MMF ( 1 g daily , increased by 1 g/day each week to 3 g daily ) .\
METHODS	From Day 1 , atacicept ( 150 mg , subcutaneously , twice weekly for 4 weeks , then weekly ) was initiated with MMF along with a tapered dose of CS .\
RESULTS	The trial was terminated after the enrollment of six patients , due to an unexpected decline in serum immunoglobulin G ( IgG ) and the occurrence of serious infections .\
RESULTS	Efficacy was thus not evaluated .\
RESULTS	By Day 1 , serum IgG levels had declined substantially in patients then randomized to atacicept ( n = 4 ) compared with placebo ( n = 2 ) .\
RESULTS	Patients receiving atacicept also had more severe proteinuria on Day -14 than those on placebo .\
RESULTS	Lymphocyte counts were low at screening in all patients .\
RESULTS	IgG decline continued following initiation ( Day 1 ) of atacicept .\
RESULTS	Three atacicept-treated patients developed serum IgG below the protocol-defined discontinuation threshold of 3 g/l , two of whom developed serious pneumonia .\
CONCLUSIONS	Future studies are needed to characterize the safety , efficacy , and pharmacodynamic response of atacicept in LN patients .\
BACKGROUND	ClinicalTrials.gov : NCT00573157 .\
\
###9701300\
OBJECTIVE	To compare three different methods of teaching CPR to parents of infants at high risk for sudden cardiopulmonary arrest and to identify characteristics that predict difficulty in learning CPR .\
METHODS	We conducted a prospective , multicenter clinical trial of 480 parents and other infant caretakers .\
METHODS	Subjects were randomly assigned to 1 of 3 CPR training protocols : an instructor-taught CPR class , an instructor-taught CPR class followed by a social support intervention , or a self-training video module .\
METHODS	CPR proficiency was evaluated with the use of a CPR skills checklist .\
RESULTS	Of 480 subjects , 301 ( 63 % ) were able to demonstrate successful CPR after training .\
RESULTS	Univariate analysis revealed that unsuccessful learners were likely to be less educated , to have lower incomes , to never have attended a previous CPR class , and to have better psychosocial adjustment to their infant 's illness , compared with successful learners .\
RESULTS	The proportion of successful learners was significantly higher in the 2 instructor-taught classes than in the self-training video class .\
RESULTS	Multiple logistic regression analysis was used to develop a predictive profile to describe unsuccessful learners .\
RESULTS	The following characteristics independently predicted unsuccessful learners : CPR learned in the self-training video group , fewer years of education , and better psychosocial adjustment .\
CONCLUSIONS	Most parents of infants at high risk for sudden death can demonstrate successful CPR skills at the completion of 1 class .\
CONCLUSIONS	However , a significant minority will require extra attention to be successful .\
CONCLUSIONS	Self-training video instruction may not be an adequate substitute for instructor-taught CPR .\
\
###15493522\
METHODS	Prospective , randomized , crossover design .\
OBJECTIVE	To compare the effectiveness of the Johnson & Johnson Back Plaster , the ABC Warme-Pflaster , and the ThermaCare HeatWrap on skin and paraspinal muscle temperature .\
OBJECTIVE	Also , to compare the subjects ' heat perception for the 3 products .\
BACKGROUND	Heat therapy is a common treatment for low back pain and disability .\
BACKGROUND	There are a number of products on the market that are suggested to relieve low back pain by providing warmth to the back ; however , their effectiveness for increasing tissue temperature compared with heat sensation has not been tested .\
METHODS	To measure paraspinal muscle temperature , 1 thermocouple monofilament was inserted into the paraspinal muscle 2 cm from the skin surface at the L3 level using a 20-gauge 1.25-in ( 3.15-cm ) sterile catheter .\
METHODS	To measure skin interface temperature , 2 thermocouples were placed on the skin at distances of 5 cm and 7 cm from the insertion site .\
METHODS	The Isothermex was used to record temperatures to the nearest 0.1 degrees C for 120 minutes .\
METHODS	The subjects also rated heat perception using a 10-cm visual analog scale at 0 , 30 , 60 , 90 , and 120 minutes .\
METHODS	Analysis of covariance models were used for statistical analysis .\
RESULTS	There was a significant product x time interaction ( F14 ,231 = 3.77 , P < .0001 ) at the intramuscular site , but there was not a significant product x time interaction ( F14 ,231 = 1.03 , P = .4228 ) at the skin site .\
RESULTS	Both the main effects for product ( F2 ,33 = 41.59 , P < .0001 ) and time ( F3 ,51 = 19.02 , P < .0001 ) were significant for the visual analog scale data .\
RESULTS	The ThermaCare HeatWrap produced significant increases in both skin and intramuscular temperatures with less heat sensation .\
RESULTS	The Johnson & Johnson Back Plaster and the ABC Warme-Pflaster increased temperature at the skin surface and provided the greatest heat sensations , but they did not provide intramuscular heat .\
CONCLUSIONS	The ThermaCare HeatWrap is more effective at increasing temperature at a 2-cm depth with less perceived heat compared to the Johnson & Johnson Back Plaster and the ABC Warme-Pflaster .\
CONCLUSIONS	The latter 2 products provide a sensation of heat but do not actually provide a muscle temperature change at a depth of 2 cm .\
\
###21098449\
BACKGROUND	Secretory phospholipase A ( 2 ) ( sPLA ( 2 ) ) may play a role in myonecrosis after elective percutaneous coronary intervention ( PCI ) .\
BACKGROUND	Inhibition of this enzyme may have a beneficial effect .\
BACKGROUND	The central hypothesis of this study was that treatment with varespladib , a small-molecule inhibitor of sPLA ( 2 ) would reduce postprocedural release of cardiac biomarkers after elective percutaneous coronary intervention .\
RESULTS	Between October 2007 and June 2009 , 144 stable patients were randomized in a phase II trial to receive varespladib 500 mg PO BID or placebo 3 to 5 days before and for 5 days after elective percutaneous coronary intervention .\
RESULTS	The primary end point was elevation of troponin I or creatine kinase-MB above the upper limit of normal at 6 to 8 or 18 to 24 hours after percutaneous coronary intervention .\
RESULTS	Mean age was 6310 and 6410 years , with 38 % and 42 % with diabetes mellitus and 29 % and 28 % with prior myocardial infarction for the varespladib and placebo groups , respectively .\
RESULTS	The primary end point occurred in 75 % of varespladib and 63 % of placebo patients ( P = 0.14 ) .\
RESULTS	Troponin I 3 times the upper limit of normal was observed in 57 % and 50 % ( P = 0.39 ) and creatine kinase-MB 2 times the upper limit of normal in 14 % and 3 % ( P = 0.018 ) .\
RESULTS	Median ( first and third quartiles ) change in high-sensitivity C-reactive protein in these 2 groups was 0.65 mg/L ( -0.18 and 1.48 ) and 0.70 mg/L ( 0.00 and 1.50 ) at 18 to 24 hours ( P = 0.81 ) and 0.20 mg/L ( -0.70 and 1.40 ) and 0.60 mg/L ( -0.12 and 1.72 ) at 3 to 5 days ( P = 0.23 ) , whereas change in sPLA ( 2 ) activity at 3 to 5 days in a subset was -2.85 ng/ml ( -3.40 and -1.85 ) and 0.25 ng/ml ( -0.20 and 0.85 ) ( P < 0.001 ) .\
CONCLUSIONS	Inhibition of sPLA ( 2 ) by varespladib administered for 3 to 5 days before the procedure does not reduce periprocedural myonecrosis associated with elective percutaneous coronary intervention .\
BACKGROUND	URL : http://www.clinicaltrials.gov .\
BACKGROUND	Unique identifier : NCT00533039 .\
\
###7721614\
OBJECTIVE	RTOG 83-07 is a Phase II randomized protocol designed to compare the efficacy and toxicity of Megestrol vs. Diethylstilbestrol ( DES ) used as cytoreductive agents prior to and during radiotherapy .\
OBJECTIVE	The end points of this study include tumor clearance rate , effect on serum testosterone , loco-regional control , disease-free interval , and survival .\
METHODS	Eligible patients were those with histologically confirmed locally advanced adenocarcinoma , clinical Stage B2 ( T2B ) and C ( T3 ) without regional lymph node involvement , or with lymph node involvement limited to the pelvis .\
METHODS	Patients were stratified by clinical stage , histological grade , and nodal status , and were randomized to receive either Megestrol 40 mg three times per day by mouth , or Diethylstilbestrol 1 mg three times per day by mouth .\
METHODS	The drugs were started 2 months prior to initiation of radiotherapy and were continued throughout the radiotherapy course .\
METHODS	Radiotherapy consisted of 44-46 Gy , 1.8-2 Gy per day to the regional lymphatics , followed by a boost to the prostate consisting of 20-25 Gy , 1.8-2 Gy per day , to a total of 65-70 Gy .\
METHODS	Serum testosterone levels were recorded throughout the treatment course .\
METHODS	Tumor response was assessed clinically and radiographically ( CT scan ) .\
METHODS	From March 1983 through June 1986 a total of 203 patients were accessioned to the study ; 198 were analyzable .\
RESULTS	Correlation of the incidence of drug-related toxicity and treatment arm assignment revealed a significantly higher incidence of complications in the Diethylstilbestrol ( DES ) arm .\
RESULTS	The most prominent were the differences in the incidence of gynecomastia ( 55 % vs. 7 % ) and fluid retention ( 21 % vs. 6 % ) .\
RESULTS	The incidence of thromboembolic phenomena was comparable ( 8 % vs. 5 % in the Megestrol arm ) .\
RESULTS	Patients on the DES arm demonstrated a significantly greater median decrease in testosterone level .\
RESULTS	Correlation of the treatment arm assignment and the rate of tumor regression and the incidence of complete response revealed no significant difference between the arms .\
RESULTS	At 7 years , 16 % of patients on the Megace arm and 21 % of patients on the DES arm manifested evidence of local failure .\
CONCLUSIONS	The results of the study indicate comparable efficacy ( using tumor clearance as an end point ) of DES and Megestrol .\
CONCLUSIONS	Although DES appears more effective in suppressing testosterone , it is also associated with a higher incidence of drug-related toxicity .\
\
###17356969\
BACKGROUND	Despite accurate diagnostic tests and effective therapies , the management of osteoporosis has been observed to be suboptimal in many settings .\
BACKGROUND	We tested the effectiveness of an intervention to improve care in patients at-risk of osteoporosis .\
METHODS	Randomized controlled trial .\
METHODS	Primary care physicians and their patients at-risk of osteoporosis , including women 65 years and over , men and women 45 and over with a prior fracture , and men and women 45 and over who recently used > or = 90 days of oral glucocorticoids .\
METHODS	A multifaceted program of education and reminders delivered to primary care physicians as well as mailings and automated telephone calls to patients .\
RESULTS	Either undergoing a bone mineral density ( BMD ) testing or filling a prescription for a bone-active medication during the 10 months of follow-up .\
RESULTS	After the intervention , 144 ( 14 % ) patients in the intervention group and 97 ( 10 % ) patients in the control group received either a BMD test or filled a prescription for an osteoporosis medication .\
RESULTS	This represents a 4 % absolute increase and a 45 % relative increase ( 95 % confidence interval 9-93 % , p = 0.01 ) in osteoporosis management between the intervention and control groups .\
RESULTS	No differences between groups were observed in the incidence of fracture .\
CONCLUSIONS	An intervention targeting primary care physicians and their at-risk patients increased the frequency of BMD testing and/or filling prescriptions for osteoporosis medications .\
CONCLUSIONS	However , the absolute percentage of at-risk patients receiving osteoporosis management remained low .\
\
###11299133\
OBJECTIVE	To establish whether or not the serotonin reuptake inhibitor ( SSRI ) sertraline can improve arousal and alertness of patients with traumatic brain injury ( TBI ) and associated diffuse axonal injury ( DAI ) .\
OBJECTIVE	Serotonin is a major inhibitory as well an excitatory neurotransmitter , and serotonergic neurons modulate the activity of brain regions responsible for motor control , arousal , attention , and emotional regulation .\
METHODS	Tertiary care inpatient rehabilitation centre directly attached to a university hospital level-one trauma centre .\
METHODS	Prospective placebo-controlled randomized trial utilizing sertraline on admission to acute rehabilitation .\
METHODS	Eleven subjects , post-high speed motor vehicle crash and post-severe TBI ( GCS < or = 8 ) with presumed DAI randomized to receive either sertraline 100mg per day or placebo for 2 weeks .\
METHODS	All subjects were within 2 weeks of acute injury .\
METHODS	Outcome measures recorded were the Orientation Log ( daily ) , Agitated Behaviour Scale ( daily ) , and the Galveston Orientation and Amnesia Test ( weekly ) .\
RESULTS	Both placebo and active medication groups demonstrated similar rates of improvement on all three scales .\
RESULTS	There was no difference in the rates of recovery for either study group ( p > 0.05 , ANOVA with repeated measures ) .\
RESULTS	The groups did not demonstrate a statistically significant negative effect on recovery either , although the size is too small for a statistically reliable beta-effect .\
CONCLUSIONS	This pilot study fails to establish whether the early use of sertraline may improve alertness , decrease agitation or improve cognitive recall of material .\
CONCLUSIONS	This may be due to the small size of the study group , the brief duration of treatment or by a skewed placebo group .\
CONCLUSIONS	Larger studies will be required to prove any efficacy .\
CONCLUSIONS	There were no complications with its use and sertraline did not demonstrate a detrimental effect on recovery .\
CONCLUSIONS	This indicates that sertraline may be safe to use in the treatment of psychiatric or behavioural complications attributable to TBI .\
\
###24510942\
OBJECTIVE	This article reports the results of a community-based , culturally tailored diabetes prevention program for overweight Mexican American adults on weight loss , waist circumference , diet and physical activity self-efficacy , and diet behaviors .\
METHODS	The intervention used content from the Diabetes Prevention Program but culturally tailored the delivery methods into a community-based program for Spanish-speaking adults of Mexican descent .\
METHODS	The design was a randomized controlled trial ( N = 58 ) comparing the effects of a 5-month educational intervention with an attention control group .\
METHODS	The primary study outcome was weight loss .\
METHODS	Secondary outcomes included change in waist circumference , body mass index , diet self-efficacy , and physical activity self-efficacy .\
RESULTS	There were significant intervention effects for weight , waist circumference , body mass index , and diet self-efficacy , with the intervention group doing better than the control group .\
RESULTS	These effects did not change over time .\
CONCLUSIONS	Findings support the conclusion that a community-based , culturally tailored intervention is effective in reducing diabetes risk factors in a 5-month program .\
\
###21863254\
BACKGROUND	Aim of the study was to investigate : 1 ) if second eye cataract surgery under topical anesthesia is more painful than surgery on the first eye , 2 ) if pain experienced during the procedure on the first eye may predict the pain of the second procedure , and 3 ) if patients ' cooperation is different between the first and the second eye procedure .\
METHODS	Seventy-three consecutive patients undergoing bilateral non-simultaneous cataract surgery were prospectively included in the study .\
METHODS	Surgical technique was sutureless clear corneal phacoemulsification under topical anesthesia .\
METHODS	Immediately after surgery every patient graded the pain experienced using a visual analogue scale ( VAS ) from 0 ( no pain ) to 10 ( unbearable pain ) .\
METHODS	At the end of each procedure the surgeon graded patients ' cooperation using a 4-point scale .\
RESULTS	Mean VAS score was 2.35 ( SD 2.63 ) for the first eye and 2.89 ( SD 2.93 ) for the second eye .\
RESULTS	Such a difference was not statistically significant ( p = 0.1777 , Wilcoxon test ) .\
RESULTS	The correlation between the VAS score of the first and that of the second procedure was statistically significant ( r = 0.5514 , p < 0.0001 , Spearman rank correlation ) .\
RESULTS	Patients ' cooperation was 2.64 ( SD 0.63 ) during the first procedure and 2.52 ( SD 0.79 ) during the second procedure ; this difference was not statistically significant ( p = 0.1769 , Wilcoxon matched-pairs signed-ranks test ) .\
CONCLUSIONS	After uneventful cataract surgery under topical anesthesia , pain experienced and cooperation did not differ between first and second eye procedures .\
CONCLUSIONS	A correlation was found between pain scores of the first and the second eye procedures .\
\
###21105974\
BACKGROUND	To evaluate the efficacy of topical 1 % voriconazole versus 5 % natamycin in treatment of fungal corneal ulcers .\
METHODS	A prospective , randomized pilot study in a tertiary care hospital .\
METHODS	Thirty patients of microbiologically proven fungal keratitis divided randomly in two groups of 15 patients each .\
METHODS	Two groups were treated with either 5 % natamycin ( group A ) or 1 % voriconazole ( group B ) topically as a primary treatment for fungal keratitis .\
METHODS	The mean size , depth of infiltrate and LogMAR visual acuity at presentation were comparable in both groups ( P > 0.05 ) .\
METHODS	Patients were followed up for minimum of 10 weeks or till complete resolution of ulcer , whichever was later .\
METHODS	Cultures to identify the causative organisms were performed .\
METHODS	Time of resolution of the ulcer .\
RESULTS	Twenty-nine of the total 30 patients showed complete resolution .\
RESULTS	Average time of resolution and gain in LogMAR visual acuity was 24.3 days and 1.12 in group A and 27.2 days and 0.77 in group B.\
RESULTS	These were comparable in the two groups ( P > 0.05 % ) .\
RESULTS	Aspergillus spp .\
RESULTS	( 40 % ) and Curvularia spp .\
RESULTS	( 30.0 % ) were found to be most common isolates .\
CONCLUSIONS	Topical 1 % voriconazole was found to be safe and effective drug in primary management of fungal keratitis , its efficacy matching conventional natamycin .\
CONCLUSIONS	There was no added advantage of using topical 1 % voriconazole over topical natamycin as primary treatment in fungal keratitis .\
\
###12711467\
BACKGROUND	Over 200000 pleural effusions are attributable to cancer in the UK and USA every year .\
BACKGROUND	Cytological examination of pleural fluid classifies about 60 % of malignant effusions .\
BACKGROUND	Pleural biopsy needs to be done in the remaining cases .\
BACKGROUND	We aimed to assess whether CT-guided biopsy is an improvement over standard pleural biopsy in this setting .\
METHODS	50 consecutive patients with cytologically negative suspected malignant pleural effusions were recruited .\
METHODS	All had a contrast-enhanced thoracic CT scan to assess pleural thickening .\
METHODS	Patients were randomly allocated , stratified by baseline pleural thickening , to either Abrams ' pleural biopsy ( standard care ; n = 25 ) or CT-guided cutting needle biopsy ( n = 25 ) .\
METHODS	Sensitivity for pleural malignancy from the biopsy specimen was the primary endpoint , with the patient 's clinical outcome after 1 year being the diagnostic gold standard .\
METHODS	Analysis was per protocol .\
RESULTS	Three patients did not undergo biopsy .\
RESULTS	Abrams ' biopsy correctly diagnosed malignancy in eight of 17 patients ( sensitivity 47 % , specificity 100 % , negative predictive value 44 % , positive predictive value 100 % ) .\
RESULTS	CT-guided biopsy correctly diagnosed malignancy in 13 of 15 ( sensitivity 87 % , specificity 100 % , negative predictive value 80 % , positive predictive value 100 % ; difference in sensitivity between Abrams ' and CT-guided 40 % , 95 % CI 10-69 , p = 0.02 ) .\
RESULTS	Diagnostic advantage was similar in patients proving to have mesothelioma .\
CONCLUSIONS	Primary use of CT-guided biopsy would avoid doing at least one Abrams ' biopsy for every 2.5 CT-guided biopsies undertaken .\
CONCLUSIONS	In cytology-negative suspected malignant pleural effusions , CT-guided pleural biopsy is a better diagnostic test than Abrams ' pleural biopsy .\
\
###17296460\
OBJECTIVE	The aim of this study was to evaluate the annhypertensive efficacy and tolerability of the angiotensin-converting enzyme inhibitor imidapril and the angiotensin II type 1 receptor antagonist candesartan in mild to moderate essential hypertension .\
METHODS	The trial was conducted at 8 centers across Portugal and Spain ( the Iberian Multicenter Imidapril Study on Hypertension [ IMISH ] Study Group ) .\
METHODS	Patients aged between 30 and 70 years with essential hypertension were eligible .\
METHODS	Following a 2 - to 4-week , single-blind , placebo run-in period , patients were randomly assigned to receive imidapril at doses of up to 20 mg/d , or candesartan at doses up to 16 mg/d , once daily in a double-blind , parallel-group design with a 12-week active-treatment period .\
METHODS	To achieve the target systolic/diastolic blood pressure ( SBP/DBP ) of < 140 / < 90 mm Hg , imidapril was titrated from 5 to 20 mg/d and candesartan was titrated from 4 to 16 mg/d .\
METHODS	The main end point was the change from baseline in sitting blood pressure ( BP ) at trough .\
METHODS	Secondary end points were response rate , evaluation of SBP and DBP throughout the study , and change of SBP and DBP in subgroup of patients with moderate hypertension , as well as incidence and severity of adverse events related to treatment reported throughout the study .\
RESULTS	The intent-to-treat analysis consisted of 122 patients ( imidapril group , 60 patients ; 32 men , 28 women ; mean [ SD ] age , 54.7 [ 9.2 ] years ; white race , 59 [ 99.2 % ] , Hispanic race , 1 [ 0.8 % ] ; mean [ SD ] weight , 80.1 [ 12.8 ] kg ; candesartan group , 62 patients ; 36 men , 26 women ; mean [ SD ] age , 53.9 [ 9.9 ] years ; white race , 62 [ 100 % ] ; mean [ SD ] weight , 77.6 [ 14.1 ] kg ) .\
RESULTS	In the imidapril group , the mean ( SD ) SBP and DBP were , respectively , 155.7 ( 10.2 ) and 96.7 ( 4.7 ) mm Hg at baseline and 139.4 ( 11.9 ) and 86.9 ( 7.6 ) mm Hg at the end of the 12-week treatment period ( visit 5 ) ; SBP had decreased significantly from baseline , by 10.5 % ( mean [ SD ] Delta , -16.3 [ 12.3 ] mm Hg [ 95 % CI , -19.5 to -13.1 ; P < 0.001 ] ) and DBP had decreased significantly , by 10.1 % ( mean [ SD ] A , -9.8 [ 7.8 ] mm Hg [ 95 % CI , -11.8 to -7.8 ; P < 0.001 ] ) .\
RESULTS	In the candesartan group , the mean ( SD ) SBP and DBP values were , respectively , 158.4 [ 11.2 ] and 98.3 [ 4.1 ] mm Hg at baseline and 139.8 [ 12.5 ] and 87.6 7.5 ] mm Hg at 12 weeks , corresponding to decreases of 11.7 % in SBP ( mean [ SD ] A , -18.6 [ 12.8 ] mm Hg [ 95 % CI , -21.9 to -15.4 ; P < 0.001 ] ) and 10.9 % in DBP ( mean [ SD ] A , -10.7 [ 7.3 ] mm Hg [ 95 % CI , -12.5 to -8.8 ; P < 0.001 ] ) .\
RESULTS	Response rates were 78.3 % ( 47/60 ) with imidapril and 69.4 % ( 43/62 ) with candesartan , and BP normalization ( < 140 / < 90 mm Hg ) was achieved in 55.0 % ( 33/60 ) of patients with imidapril and 45.2 % ( 28/62 ) of patients with candesartan .\
RESULTS	The incidences of adverse events were similar between groups .\
RESULTS	Most ( 73.9 % ) adverse events were mild in intensity .\
RESULTS	A serious adverse event ( severe anxiety ) was reported in the candesartan group and led to study discontinuation .\
RESULTS	No cases of dry cough or hypotension were reported .\
CONCLUSIONS	The results of this study suggest that imidapril once daily at doses up to 20 mg and candesartan once daily at doses up to 16 mg were effective in this population of mildly to moderately hypertensive patients .\
CONCLUSIONS	Both treatments were well tolerated .\
\
###9108809\
BACKGROUND	This pilot study compared the efficacy of lithium plus divalproex sodium with the efficacy of lithium alone for the continuation and maintenance treatment of patients with bipolar I disorder .\
METHODS	Twelve patients with bipolar I disorder as defined by the DSM-III-R were recruited and followed prospectively for up to 1 year .\
METHODS	Each subject received lithium at serum levels of 0.8 to 1.0 mmol/L and a management/education session weekly or every 2 weeks .\
METHODS	By random assignment , subjects received either divalproex sodium or placebo in conjunction with lithium .\
METHODS	Divalproex sodium was adjusted to achieve a serum concentration of 50 to 125 micrograms/mL .\
METHODS	Adjunctive medications were used on an as needed basis to treat psychosis , depression , and anxiety .\
METHODS	The course of illness was monitored through use of the Longitudinal Interval Follow-up Examination .\
RESULTS	Subjects treated with the combination of lithium and divalproex were significantly less likely to suffer a relapse or recurrence ( p = .014 ) , but were significantly more likely to suffer at least one moderate or severe adverse side effect ( p = .041 ) .\
RESULTS	There was no significant difference between groups in the use of adjunctive medication .\
CONCLUSIONS	These results provide preliminary evidence of the risks and benefits of combining lithium with divalproex sodium for the continuation and maintenance treatment of bipolar I disorder .\
\
###18054611\
BACKGROUND	Recent studies suggest that high-dose MgSO4 therapy is safe and reduces the incidence of DIND and subsequent poor outcome after SAH .\
BACKGROUND	We intended to assess the safety and efficacy of high-dose MgSO4 therapy after SAH as means to prevent DIND and to evaluate the impact on clinical outcome .\
METHODS	This was a prospective , randomized , single-blind , placebo-controlled study .\
METHODS	The MgSO4 infusion was adjusted every 12 hours until day 12 according to the target serum Mg2 + level .\
METHODS	The occurrence of DIND , secondary infarction , side effects , and the outcome after 3 and 12 months were assessed .\
RESULTS	Fifty-eight patients were randomized ; 27 received placebo and 31 MgSO4 .\
RESULTS	The difference in occurrence of DIND and secondary infarction was not significant .\
RESULTS	The intention-to-treat analysis revealed a trend toward better outcome ( P = .083 ) after 3 months .\
RESULTS	On-treatment analysis showed a significantly better outcome after 3 months ( P = .017 ) and a trend toward better outcome after 1 year ( P = .083 ) .\
RESULTS	Significantly more often hypotension ( P = .040 ) and hypocalcemia ( P = .005 ) occurred as side effects in the treatment group .\
RESULTS	In 16 patients ( 52 % ) , the MgSO4 therapy had to be stopped before day 12 because of side effects .\
RESULTS	No predictive factor leading to termination was found in a postrandomization analysis .\
CONCLUSIONS	High-dose MgSO4 therapy might be efficient as a prophylactic adjacent therapy after SAH to reduce the risk for poor outcome .\
CONCLUSIONS	Nevertheless , because of the high frequency of the side effects , patients should be observed in an intensive or intermediate care setting .\
\
###16086878\
OBJECTIVE	Treating advanced non-small cell lung cancer ( NSCLC ) is difficult .\
OBJECTIVE	The response rate ( RR ) of NSCLC patients to traditional chemotherapy regimen is about 40 % .\
OBJECTIVE	Now the RR has been improved with application of new drugs , such as taxol , docetaxal , and gemzar .\
OBJECTIVE	This randomized trial was designed to determine treatment efficacies of docetaxol plus cisplatin and gemzar plus cisplatin on advanced NSCLC , and observe their cytotoxicities .\
METHODS	A total of 43 advanced NSCLC patients were randomized into 2 groups , 22 in TP group ( docetaxol plus cisplatin ) and 21 in GP group ( gemzar plus cisplatin ) , and received relevant treatments .\
METHODS	The RR , time to progression ( TTP ) , mean survival time ( MST ) , and 1 - and 2-year survival rates of the patients were analyzed .\
RESULTS	The RR was 45.4 % in TP group with 1 case of complete remission ( CR ) and 9 cases of partial remission ( PR ) , and 42.9 % in GP group with 9 cases of PR .\
RESULTS	The TTP was 4.6 months in TP group , and 4.7 months in GP group ; the MST was 10.6 months in TP group [ 95 % confidence interval ( CI ) , 9.3-11 .3 months ] , and 11.3 months in GP group ( 95 % CI , 6.8-14 .8 months ) .\
RESULTS	The 1 - and 2-year survival rates were 38.1 % and 15.3 % in TP group , and 34.1 % and 11.2 % in GP group .\
RESULTS	The differences of RR and survival rate between the 2 groups were not significant ( P = 0.71 , P = 0.89 ) .\
RESULTS	The major cytotoxicity of TP was leukopenia the major cytotoxicities of GP group were fatigue and thrombocytopenia .\
RESULTS	All adverse reactions were tolerable .\
CONCLUSIONS	TP and GP regimens may enhance the remission rate of NSCLC patients with tolerable adverse reaction , and improve the short-term survival rate , but the differences in treatment efficacies of TP and GP groups are not significant .\
\
###21317170\
OBJECTIVE	Teduglutide , a GLP-2 analogue , may restore intestinal structural and functional integrity by promoting repair and growth of the mucosa and reducing gastric emptying and secretion , thereby increasing fluid and nutrient absorption in patients with short bowel syndrome ( SBS ) .\
OBJECTIVE	This 24-week placebo-controlled study evaluated the ability of teduglutide to reduce parenteral support in patients with SBS with intestinal failure .\
METHODS	In 83 patients randomised to receive subcutaneous teduglutide 0.10 mg/kg/day ( n = 32 ) , 0.05 mg/kg/day ( n = 35 ) or placebo ( n = 16 ) once daily , parenteral fluids were reduced at 4-week intervals if intestinal fluid absorption ( 48 h urine volumes ) increased 10 % .\
METHODS	Responders were subjects who demonstrated reductions of 20 % in parenteral volumes from baseline at weeks 20 and 24 .\
METHODS	The primary efficacy end point , a graded response score ( GRS ) , took into account higher levels and earlier onset of response , leading to longer duration of response .\
METHODS	The intensity of the response was defined as a reduction from baseline in parenteral volume ( from 20 % to 100 % ) , and the duration of the response was considered the response at weeks 16 , 20 and 24 .\
METHODS	The results were tested according to a step-down procedure starting with the 0.10 mg/kg/day dose .\
RESULTS	Using the GRS criteria , teduglutide in a dose of 0.10 mg/kg/day did not have a statistically significant effect compared with placebo ( 8/32 vs 1/16 , p = 0.16 ) , while teduglutide in a dose of 0.05 mg/kg/day had a significant effect ( 16/35 , p = 0.007 ) .\
RESULTS	Since parenteral volume reductions were equal ( 353 475 and 354 334 ml/day ) , the trend towards higher baseline parenteral volume ( 1816 1008 vs 1374 639 ml/day , p = 0.11 ) in the 0.10 mg/kg/day group compared with the 0.05 mg/kg/day group may have accounted for this discrepancy .\
RESULTS	Three teduglutide-treated patients were completely weaned off parenteral support .\
RESULTS	Serious adverse events were distributed similarly between active treatment groups and placebo .\
RESULTS	Villus height , plasma citrulline concentration and lean body mass were significantly increased with teduglutide compared with placebo .\
CONCLUSIONS	Teduglutide was safe , well tolerated , intestinotrophic and suggested pro-absorptive effects facilitating reductions in parenteral support in patients with SBS with intestinal failure .\
CONCLUSIONS	ClinicalTrials.gov number NCT00172185 .\
\
###25332243\
OBJECTIVE	High-dose interferon ( IFN ) for 1 year ( HDI ) is the US Food and Drug Administration-approved adjuvant therapy for patients with high-risk melanoma .\
OBJECTIVE	Efforts to modify IFN dose and schedule have not improved efficacy .\
OBJECTIVE	We sought to determine whether a shorter course of biochemotherapy would be more effective .\
METHODS	S0008 ( S0008 : Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma ) was an Intergroup phase III trial that enrolled high-risk patients ( stage IIIA-N2a through IIIC-N3 ) , randomly assigning them to receive either HDI or biochemotherapy consisting of dacarbazine , cisplatin , vinblastine , interleukin-2 , IFN alfa-2b ( IFN -- 2b ) and granulocyte colony-stimulating factor given every 21 days for three cycles .\
METHODS	Coprimary end points were relapse-free survival ( RFS ) and overall survival ( OS ) .\
RESULTS	In all , 432 patients were enrolled .\
RESULTS	Grade 3 and 4 adverse events occurred in 57 % and 7 % of HDI patients and 36 % and 40 % of biochemotherapy patients , respectively .\
RESULTS	At a median follow-up of 7.2 years , biochemotherapy improved RFS ( hazard ratio [ HR ] , 0.75 ; 95 % CI , 0.58 to 0.97 ; P = .015 ) , with a median RFS of 4.0 years ( 95 % CI , 1.9 years to not reached [ NR ] ) versus 1.9 years for HDI ( 95 % CI , 1.2 to 2.8 years ) and a 5-year RFS of 48 % versus 39 % .\
RESULTS	Median OS was not different ( HR , 0.98 ; 95 % CI , 0.74 to 1.31 ; P = .55 ) , with a median OS of 9.9 years ( 95 % CI , 4.62 years to NR ) for biochemotherapy versus 6.7 years ( 95 % CI , 4.5 years to NR ) for HDI and a 5-year OS of 56 % for both arms .\
CONCLUSIONS	Biochemotherapy is a shorter , alternative adjuvant treatment for patients with high-risk melanoma that provides statistically significant improvement in RFS but no difference in OS and more toxicity compared with HDI .\
\
###7665750\
OBJECTIVE	To evaluate a least squares fitting technique for the purpose of measuring total respiratory compliance ( Crs ) and resistance ( Rrs ) in patients submitted to partial ventilatory support , without the need for esophageal pressure measurement .\
METHODS	Prospective , randomized study .\
METHODS	A general ICU of a University Hospital .\
METHODS	11 patients in acute respiratory failure , intubated and assisted by pressure support ventilation ( PSV ) .\
METHODS	Patients were ventilated at 4 different levels of pressure support .\
METHODS	At the end of the study , they were paralyzed for diagnostic reasons and submitted to volume controlled ventilation ( CMV ) .\
RESULTS	A least squares fitting ( LSF ) method was applied to measure Crs and Rrs at different levels of pressure support as well as in CMV .\
RESULTS	Crs and Rrs calculated by the LSF method were compared to reference values which were obtained in PSV by measurement of esophageal pressure , and in CMV by the application of the constant flow , end-inspiratory occlusion method .\
RESULTS	Inspiratory activity was measured by P0 .1 .\
RESULTS	In CMV , Crs and Rrs measured by the LSF method are close to quasistatic compliance ( -1.5 + / - 1.5 ml/cmH2O ) and to the mean value of minimum and maximum end-inspiratory resistance ( +0.9 + / - 2.5 cmH2O / ( l/s ) ) .\
RESULTS	Applied during PSV , the LSF method leads to gross underestimation of Rrs ( -10.4 + / - 2.3 cmH2O / ( l/s ) ) and overestimation of Crs ( +35.2 + / - 33 ml/cmH2O ) whenever the set pressure support level is low and the activity of the respiratory muscles is high ( P0 .1 was 4.6 + / - 3.1 cmH2O ) .\
RESULTS	However , satisfactory estimations of Crs and Rrs by the LSF method were obtained at increased pressure support levels , resulting in a mean error of -0.4 + / - 6 ml/cmH2O and -2.8 + / - 1.5 cmH2O / ( l/s ) , respectively .\
RESULTS	This condition was coincident with a P0 .1 of 1.6 + / - 0.7 cmH2O .\
CONCLUSIONS	The LSF method allows non-invasive evaluation of respiratory mechanics during PSV , provided that a near-relaxation condition is obtained by means of an adequately increased pressure support level .\
CONCLUSIONS	The measurement of P0 .1 may be helpful for titrating the pressure support in order to obtain the condition of near-relaxation .\
\
###19852201\
BACKGROUND	Inhaled corticosteroids are widely used in the treatment of persistent asthma , usually combined with inhaled beta2-agonists .\
BACKGROUND	Previous research suggests that short-acting beta2-agonists ( SABAs ) may downregulate the anti-inflammatory effects of inhaled corticosteroids , thereby increasing asthma morbidity .\
OBJECTIVE	To determine whether 3-bromotyrosine and 3,5-dibromotyrosine levels , specific markers of eosinophil activation , reflect treatment effects on airway inflammation of inhaled corticosteroids and SABAs and support previous conclusions .\
METHODS	Levels of 3-bromotyrosine and 3,5-dibromotyrosine were measured in sputum supernatants using stable isotope dilution gas chromatography-mass spectrometry in a randomized , placebo-controlled , crossover study of treatment with terbutaline , budesonide , and their combination in patients with persistent asthma .\
METHODS	Thirty-four individuals were randomized , and 28 completed the study .\
RESULTS	Treatment with budesonide lowered median 3-bromotyrosine levels compared with treatment with placebo , terbutaline , and budesonide-terbutaline ( 0.24 vs 0.64 , 0.62 , and 0.43 3-bromotyosine/tyrosine [ mmol/mol ] ; P < .05 ) and lowered median 3,5-dibromotyrosine levels compared with placebo and terbutaline treatments ( 0.04 vs 0.11 and 0.07 3,5-dibromotyrosine / tyrosine [ mmol/mol ] , P < .05 ) .\
RESULTS	Unlike eosinophil numbers , 3-bromotyrosine and 3,5-dibromotyrosine levels did not increase with terbutaline treatment compared with placebo treatment but were significantly raised when terbutaline was added to budesonide treatment .\
RESULTS	3-Bromotyrosine levels correlated significantly with eosinophil cationic protein levels in all groups .\
CONCLUSIONS	3-Bromotyrosine and 3,5-dibromotyrosine levels reflect treatment effects in asthma and support previous findings that SABAs impair the anti-inflammatory effects of inhaled corticosteroids .\
CONCLUSIONS	In addition to eosinophil numbers and eosinophil cationic protein levels , these modified tyrosine residues provide useful information about the inflammatory state of the airways .\
\
###8985797\
OBJECTIVE	Pulmonary rehabilitation programs often show beneficial effects in patients with chronic obstructive pulmonary disease ( COPD ) .\
OBJECTIVE	These programs are usually hospital-based .\
OBJECTIVE	This study assesses the feasibility and application of a 12-week Home-Care Rehabilitation Program ( HCRP ) , carried out by general practitioners , physiotherapists , and home-care nurses .\
METHODS	Effects of the HCRP are assessed in 15 COPD patients with moderate to severe airflow limitation ( inspiratory vital capacity [ IVC ] : mean , 75.4 [ SD , 13.7 ] percent predicted , mean FEV1 : 45.5 [ 6.9 ] percent predicted ) and are compared with a stratified and randomized control group ( n = 15 ) .\
RESULTS	All participating disciplines judged the program to be useful and feasible .\
RESULTS	Patient compliance with the rehabilitation exercises was high .\
RESULTS	No major problems concerning the rehabilitation program were reported .\
RESULTS	After the HCRP , 4-minute walking distance improved significantly from 274 m [ 61 ] to 301 m [ 72 ] and maximal work load ( W max ) , as measured during an incremental cycle test , increased from 75.3 W [ 24 ] to 85.3 W [ 28 ] .\
RESULTS	At equal work levels ( W submax ) during the cycle test both Borg dyspnea and leg effort scores decreased significantly after the HCRP ( 6.7 [ 1.3 ] versus 4.9 [ 1.7 ] and 4.2 [ 2.0 ] versus 1.7 [ 2.5 ] , respectively ) .\
RESULTS	Changes in walking distance , dyspnea , and leg effort scores at W submax were significantly different between the two groups .\
RESULTS	IVC and FEV1 did not change significantly .\
RESULTS	In the control group , no significant changes in any parameter were observed .\
CONCLUSIONS	It was possible to design and perform successfully a home-care rehabilitation program , providing both objective and subjective improvements in a group of patients with COPD .\
CONCLUSIONS	A home-care rehabilitation program appears to be a valuable component in the management of COPD patients with a moderate to severe airflow limitation .\
\
###9207646\
OBJECTIVE	Our objective was to test fractal dimension ( D ) , a measure of clustering of ventricular premature complexes ( VPCs ) , on entry Holter recording as a predictor of future arrhythmic death and other-cause mortality in postinfarction patients in the Cardiac Arrhythmic Suppression Trial ( CAST ) .\
BACKGROUND	Nonlinear dynamic methods of signal processing are being applied in medicine to provide new insights into apparently `` chaotic '' biologic events , including cardiac arrhythmias .\
BACKGROUND	One such application is the derivation of a fractal D to describe the clustering of VPCs in time .\
METHODS	Baseline Holter recordings were analyzed in blinded manner for 484 patients : 237 died or had a resuscitated cardiac arrest during follow-up , and 247 matched patients had no events .\
METHODS	Fractal D , measured in four ways , was assessed as a predictor using Cox regression .\
RESULTS	One measure of D ( high resolution D ) was a significant univariate ( relative hazard ratio 0.79 per SD change , p = 0.011 ) and multivariate ( hazard ratio 0.75 , p = 0.046 ) predictor of arrhythmic death but not other death ( univariate p = 0.95 , relative hazard 0.95 , p = 0.66 ) .\
RESULTS	Fractal D was greater ( VPCs less clustered ) in those patients free of arrhythmic events .\
RESULTS	On subgroup analysis , the predictive value of D resided in the randomized patient group ( i.e. , those who showed VPC suppression during initial antiarrhythmic drug titration and were randomized to blinded therapy with active drug or placebo ) ( multivariate hazard ratio 0.57 , p = 0.001 ) .\
CONCLUSIONS	A high resolution fractal D was predictive of arrhythmic ( but not nonarrhythmic ) death in a large postinfarction cohort .\
CONCLUSIONS	Further study of this new signal processing approach to ambulatory electrocardiographic recording will be of interest .\
\
###17652885\
BACKGROUND	Minor myocardial damage after percutaneous coronary intervention ( PCI ) is associated with cardiac risks , which statins seem to reduce .\
BACKGROUND	The aim of this study was to examine whether intensive lipid-lowering therapy is more effective in decreasing the risk of cardiac injury after PCI than moderate lipid-lowering therapy .\
RESULTS	Subjects comprised 42 patients with stable angina without previous statin treatment , randomly assigned to either an intensive lipid-lowering group ( Group A : target low-density lipoprotein-cholesterol ( LDL-C ) < 70 mg/dl ) or a moderate lipid-lowering group ( Group B : target LDL-C < 100 mg/dl ) 2 weeks before PCI .\
RESULTS	All patients took statins to reach target LDL-C levels .\
RESULTS	Incidence of periprocedural myocardial injury was assessed by analyzing levels of creatine kinase myocardial isozyme ( CK-MB ) and cardiac troponin T ( TnT ) before and 6 , 12 and 24 h after PCI .\
RESULTS	Minor myocardial damage was defined as TnT elevation to > 0.01 ng/ml .\
RESULTS	Frequency of minor myocardial damage was 14.2 % in Group A and 47.6 % in Group B ( p = 0.043 ) .\
RESULTS	CK-MB was above the upper limit of normal ( ULN ) in 19 % of Group A and 33.3 % of Group B ( p = 0.44 ) , and CK-MB was > 3x ULN in 9.5 % of Group A and 19 % of Group B ( p = 0.66 ) .\
CONCLUSIONS	Intensive lipid-lowering therapy before PCI reduces minor myocardial damage during PCI with stenting compared with moderate lipid-lowering therapy .\
\
###17134849\
BACKGROUND	The role of dopamine in cocaine abuse has been long recognized .\
BACKGROUND	Cocaine use can profoundly alter dopaminergic functioning through depletion of this monoamine and changes in receptor functioning .\
BACKGROUND	Based on these facts , levodopa ( L-dopa ) pharmacotherapy may be helpful in reducing or abolishing cocaine use .\
OBJECTIVE	The current studies sought to evaluate the safety , tolerability and efficacy of L-dopa as a treatment for cocaine dependence .\
METHODS	In Study 1 , 67 cocaine-dependent subjects were randomized in a 5-week , double-blind , placebo-controlled safety trial .\
METHODS	Subjects received either placebo , or 400 mg L-dopa plus 100 mg of the peripheral decarboxylase inhibitor , carbidopa , in a sustained-release preparation ( Sinemet CR ) .\
METHODS	In Study 2 , 122 cocaine-dependent subjects were enrolled in a 9-week , randomized , double-blind , placebo-controlled trial to compare placebo to 400/100 mg and 800/200 mg L-dopa/carbidopa treatments .\
METHODS	Placebo or L-dopa were administered twice daily in both studies .\
RESULTS	L-dopa was well tolerated with similar retention and medication adherence rates compared to placebo .\
RESULTS	Only two side effects occurred more often in L-dopa-treated patients : nausea and dizziness .\
RESULTS	L-dopa lowered diastolic blood pressure in a dose-dependent fashion .\
RESULTS	In these trials , L-dopa had no effect on cocaine use , cocaine craving , or mood .\
CONCLUSIONS	These two studies demonstrate the safety and tolerability of L-dopa pharmacotherapy in cocaine-dependent patients .\
CONCLUSIONS	No evidence for greater efficacy of L-dopa compared to placebo was observed .\
CONCLUSIONS	The possibility of enhancing treatment effects by combining L-dopa with other behavioral or pharmacological interventions is discussed .\
\
###24563240\
OBJECTIVE	Due to the gap in suicide-specific intervention training for mental health students and professionals , e-learning is one solution to improving provider skills in the Veterans Affairs ( VA ) health system .\
OBJECTIVE	This study focused on the development and evaluation of an equivalent e-learning alternative to the Collaborative Assessment and Management of Suicidality ( CAMS ) in-person training approach at a Veteran Health Affairs medical center .\
METHODS	The study used a multicenter , randomized , cluster , and three group design .\
METHODS	the development of e-CAMS was an iterative process and included pilot testing .\
METHODS	Eligible and consenting mental health providers , who completed a CAMS pre-survey , were randomized .\
METHODS	Provider satisfaction was assessed using the standard VA evaluation of training consisting of 20 items .\
METHODS	Two post training focus groups , divided by learning conditions , were conducted to assess practice adoption using a protocol focused on experiences with training and delivery of CAMS .\
RESULTS	A total of 215 providers in five sites were randomized to three conditions : 69 to e-learning , 70 to in-person , 76 to the control .\
RESULTS	The providers were primarily female , Caucasian , midlife providers .\
RESULTS	Based on frequency scores of satisfaction items , both learning groups rated the trainings positively .\
RESULTS	In focus groups representing divided by learning conditions , participants described positive reactions to CAMS training and similar individual and institutional barriers to full implementation of CAMS .\
CONCLUSIONS	This is the first evaluation study of a suicide-specific e-learning training within the VA. .\
CONCLUSIONS	The e-CAMS appears equivalent to the in-person CAMS in terms of provider satisfaction with training and practice adoption , consistent with other comparisons of training deliveries across specialty areas .\
CONCLUSIONS	Additional evaluation of provider confidence and adoption and patient outcomes is in progress .\
CONCLUSIONS	The e-CAMS has the potential to provide ongoing training for VA and military mental health providers and serve as a tutorial for psychiatrists in preparation for specialty boards .\
\
###9222944\
OBJECTIVE	To investigate the possible role played by endogenous dopamine as a modulator of renal sodium ( Na + ) reabsorption after a combined Na + and volume load .\
METHODS	A randomized placebo-controlled study .\
METHODS	Ten healthy volunteers and four hypertensive patients were subjected to intravenous infusions of 21 0.9 % saline ( 308 mmol Na + ) administered from 1000 to 1300 h after oral administration of placebo or of carbidopa , a dopamine decarboxylase inhibitor .\
RESULTS	Studies on control subjects after placebo showed that natriuresis occurred during the 6 h after commencement of the saline infusion , with falls in plasma albumin concentration , plasma renin activity and plasma aldosterone concentration ; in comparison with results of mock infusion ( 6 mmol Na + ) there was no change in the urinary excretion of dopamine and noradrenaline ( In their free or conjugated forms ) .\
RESULTS	There was , however , a marked surge in excretion of urinary conjugated dopamine and in the dopamine : noradrenaline ratio from 1300 to 1600 h , after either type of infusion .\
RESULTS	Administration of carbidopa before the saline infusion resulted in a marked decrease in excretion of urinary free dopamine , but had no effect on the surge in excretion of urinary conjugated dopamine .\
RESULTS	Saline infusion decreased proximal fractional Na + reabsorption .\
RESULTS	Administration of carbidopa delayed but did not prevent this decrease .\
RESULTS	The effects of saline infusion and of carbidopa on the urinary excretion of dopamine and noradrenaline from hypertensive patients were similar to those observed with the healthy volunteers .\
CONCLUSIONS	These findings indicate that volume expansion by intravenous saline infusion has no appreciable effect on the urinary free dopamine excretion from normal or hypertensive humans ; with any apparent increase , it is important to exclude the possibility of conversion of conjugates to free dopamine in vitro .\
CONCLUSIONS	Furthermore , that carbidopa administration did not inhibit the afternoon surge of conjugated dopamine suggests that administration of carbidopa is deficient as a tool to investigate the functional role of the renal dopamine system .\
\
###17472819\
OBJECTIVE	The aim of this study was to assess the efficacy and tolerability of nebulized arformoterol tartrate ( a selective , long-acting beta ( 2 ) - adrenergic agonist that is the [ R , R ] isomer of formoterol ) and salmeterol xinafoate versus placebo in patients with chronic obstructive pulmonary disease ( COPD ) .\
METHODS	This 12-week , multicenter , randomized , double-blind , double-dummy , placebo - and active-controlled trial was conducted at 60 centers across the United States .\
METHODS	Male and female patients aged > or = 35 years with physician-diagnosed COPD received arformoterol ( 15 microg BID , 25 microg BID , or 50 microg QD via nebulizer ) , salmeterol ( 42 microg BID via metered dose inhaler ) , or placebo .\
METHODS	Pulmonary function was assessed by spirometry ; dyspnea , by the Transitional Dyspnea Index ( TDI ) ; and health status , by the St. George 's Respiratory Questionnaire ( SGRQ ) .\
METHODS	Adverse events ( AEs ) were assessed by site personnel at all clinic visits ( screening , first dose at week 0 , and at weeks 3 , 6 , 9 , 12 , and follow-up ) .\
METHODS	COPD exacerbations were defined as worsening respiratory status requiring a change in medication or an unscheduled provider visit .\
RESULTS	A total of 717 patients received study medication .\
RESULTS	The demographic composition of all treatment arms was similar .\
RESULTS	The mean age was 62.9 years , 58 % were men , and mean baseline forced expiratory volume in 1 second ( FEV ( 1 ) ) was 1.2 L ( 41 % predicted ) .\
RESULTS	Mean improvement in trough FEV ( 1 ) over 12 weeks was significantly greater with all 3 arformoterol doses ( 15 microg BID , +16.9 % ; 25 microg BID , +18.9 % ; 50 microg QD , +14.9 % ) and for salmeterol ( +17.4 % ) relative to placebo ( +6.0 % ; P < 0.001 ) .\
RESULTS	There were significantly greater improvements in the mean percentage change in FEV ( 1 ) AUC ( 0-12h ) from the predose value over 12 weeks ( 15 microg BID , 12.7 % , 25 microg BID , 13.9 % , 50 microg QD , 18.9 % ; salmeterol , 9.8 % ) versus placebo ( 2.7 % ; P < or = 0.001 ) ; all doses of arformoterol were statistically different from salmeterol for this end point ( P < or = 0.024 ) .\
RESULTS	At week 12 , TDI focal scores were significantly greater with all arformoterol doses compared with placebo ( mean [ 95 % CI ] : 15 microg BID , 0.97 [ 0.25-1 .69 ] ; 25 microg BID , 1.08 [ 0.3-1 .86 ] ; 50 microg QD , 1.04 [ 0.32-1 .771 ) , suggesting treatment-associated improvement in dyspnea , however , the difference between salmeterol and placebo was not statistically significant ( 0.36 [ -0.40 to 1.12 ] ) .\
RESULTS	Improvements in health status , as measured using SGRQ total scores , were -2.6 to -3.6 U in the arformoterol groups , -4.4 U for salmeterol , and -1.2 U for placebo ; 95 % CI of differences versus placebo suggested significant improvement for the arformoterol 25 microg BID and salmeterol groups .\
RESULTS	There was a similar frequency of AEs and COPD exacerbations across all groups , including placebo .\
CONCLUSIONS	In this trial , patients with moderate to severe COPD administered nebulized arformoterol over 12 weeks were observed to have significant and sustained improvements in airway function and dyspnea compared with placebo .\
CONCLUSIONS	The results also suggest that all doses of arformoterol , including the lowest dose ( 15 microg BID ) , were effective .\
CONCLUSIONS	Overall , nebulized arformoterol was well tolerated .\
\
###23249535\
OBJECTIVE	To compare the effectiveness of additional moxibustion at point BL67 with moxibustion at a non-specific acupuncture point and with usual care alone to correct non-vertex presentation .\
METHODS	This was a multicentre randomised controlled trial in which 406 low-risk pregnant women with a fetus in ultrasound breech presentation , with a gestational age of 33-35 weeks , were assigned to ( 1 ) true moxibustion at point BL67 plus usual care ; ( 2 ) moxibustion at SP1 , a non-specific acupuncture point ( sham moxibustion ) plus usual care ; or ( 3 ) usual care alone .\
METHODS	The primary outcome was cephalic presentation at birth .\
METHODS	Women were recruited at health centres in primary healthcare .\
RESULTS	In the true moxibustion group , 58.1 % of the full-term presentations were cephalic compared with 43.4 % in the sham moxibustion group ( RR 1.34 , 95 % CI 1.05 to 1.70 ) and 44.8 % of those in the usual care group ( RR 1.29 , 95 % CI 1.02 to 1.64 ) .\
RESULTS	The reduction in RR of the primary outcome in women allocated to the true moxibustion group compared with the usual care group was 29.7 % ( 95 % CI 3.1 % to 55.2 % ) and the number needed to treat was 8 ( 95 % CI 4 to 72 ) .\
RESULTS	There were no severe adverse effects during the treatment .\
CONCLUSIONS	Moxibustion at acupuncture point BL67 is effective and safe to correct non-vertex presentation when used between 33 and 35 weeks of gestation .\
CONCLUSIONS	We believe that moxibustion represents a treatment option that should be considered to achieve version of the non-vertex fetus .\
BACKGROUND	Current Controlled Trials ISRCTN10634508 .\
\
###16923694\
OBJECTIVE	Docosahexaenoic acid ( DHA , 22:6 n-3 ) is considered an essential fatty acid for the fetus and newborn infant , but the optimal level of supply is not known .\
OBJECTIVE	We studied the effect of supplementing pregnant and lactating women with marine n-3 polyunsaturated fatty acids ( PUFAs ) as compared to n-6 PUFAs related to maternal and infant lipid levels .\
METHODS	Five hundred and ninety pregnant women in weeks 17-19 of pregnancy were recruited .\
METHODS	They were given either 10 mL cod liver oil ( n-3 PUFAs ) or corn oil ( n-6 PUFAs ) daily until three months after delivery , and 341 women took part in the study until giving birth .\
RESULTS	Maternal supplementation with cod liver oil increased the concentration of DHA in maternal as well as infant plasma and umbilical tissue phospholipids , as compared to corn oil .\
RESULTS	The maternal plasma triacylglycerol increase during pregnancy was less pronounced in women supplemented with cod liver oil as compared to corn oil .\
RESULTS	The concentration of high-density lipoprotein ( HDL ) - cholesterol was unchanged during pregnancy in the cod liver oil group , whereas it decreased in the corn oil group , promoting a greater increase in the ratio of total cholesterol/HDL-cholesterol in the corn oil group .\
CONCLUSIONS	Maternal supplementation with n-3 fatty acids during pregnancy and lactation provides more DHA to the infant and reduces maternal plasma lipid levels compared to supplementation with n-6 fatty acids .\
\
###23433618\
OBJECTIVE	Increasing awareness about the importance of preventive dental care among low-income families has been considered to be key to overcoming nonfinancial access to care barriers for children .\
OBJECTIVE	The purpose of this randomized , controlled trial was to measure the impact of postcard mailings on dental utilization by low-income children through a dental society program designed to increase access to dental care .\
METHODS	Five thousand eight hundred and seven low-income 2 - to 4-year-olds were randomly assigned to 1 of 3 groups : ( 1 ) Group 1 ( n = 2,014 ) received postcards containing information on how to enroll in the Yakima County Access to Baby and Child Dentistry program ; ( 2 ) Group 2 ( n = 2,014 ) received the enrollment information as well as additional information on the availability of fluoride varnish and the need to visit the dentist by the age of 1-year-old ; and ( 3 ) Group 3 ( n = 1,779 ) did not receive postcards .\
RESULTS	Preventive services utilization rates were not different among the groups : 61 % for Group 1 , 62 % for Group 2 , and 60 % for Group 3 , although rates were high for a Medicaid population .\
CONCLUSIONS	Postcard mailings did not significantly increase utilization of preventive dental services .\
CONCLUSIONS	Other strategies to increase utilization of preventive oral health measures are needed .\
\
###20394460\
OBJECTIVE	To investigate the effect of pharmacist management of poorly controlled diabetes mellitus in a community-based primary care group .\
METHODS	Randomized controlled trial of pharmacist management of diabetes compared with usual medical care .\
METHODS	Patients 18 years or older with glycosylated hemoglobin ( A1C ) levels of 9.0 % or higher were enrolled .\
METHODS	Patients were randomly assigned to an intervention group ( n = 52 ) or a control group ( n = 51 ) .\
METHODS	Management in the control group included the use of registries and targeted patient outreach .\
METHODS	The intervention group participated in the same outreach program plus medication management , patient education , and disease control by a pharmacist .\
RESULTS	Nonparametric data showed median A1C decreases of 1.50 % for the intervention group and 0.40 % for the control group ( P = .06 ) .\
RESULTS	Significantly more patients in the intervention group improved their A1C level by at least 1.0 % relative to the control group ( 67.3 % vs 41.2 % , P = .02 ) .\
RESULTS	Most of this benefit was seen for patients of nonwhite race/ethnicity compared with control subjects ( 56.3 % vs 22.7 % , P = .03 ) .\
RESULTS	Male patients showed significantly greater benefit as well , with a median A1C decrease of 1.90 % vs 0.15 % for controls ( P = .03 ) .\
CONCLUSIONS	Patients with poorly controlled diabetes improved A1C levels significantly when pharmacist management was added to an aggressive organizational diabetes management program .\
CONCLUSIONS	Our results suggest that clinically trained pharmacists can help primary care providers improve diabetes management , especially among male patients and among patients of nonwhite race/ethnicity .\
\
###10935688\
BACKGROUND	The viral protease inhibitor ritonavir has the capacity to inhibit and induce the activity of cytochrome P450-3A ( CYP3A ) isoforms , leading to drug interactions that may influence the efficacy and toxicity of other antiretroviral therapies , as well as pharmacologic treatments of coincident or complicating diseases .\
METHODS	The inhibitory effect of ritonavir on the biotransformation of the hypnotic agents triazolam and zolpidem was tested in vitro using human liver microsomes .\
METHODS	In a double-blind clinical study , volunteer study subjects received 0.125 mg triazolam or 5.0 mg zolpidem concurrent with low-dose ritonavir ( four doses of 200 mg ) , or with placebo .\
RESULTS	Ritonavir was a potent in vitro inhibitor of triazolam hydroxylation but was less potent as an inhibitor of zolpidem hydroxylation .\
RESULTS	In the clinical study , ritonavir reduced triazolam clearance to < 4 % of control values ( p < .005 ) , prolonged elimination half-life ( 41 versus 3 hours ; p < .005 ) , and magnified benzodiazepine agonist effects such as sedation and performance impairment .\
RESULTS	In contrast , ritonavir reduced zolpidem clearance to 78 % of control values ( p < .08 ) , and slightly prolonged elimination half-life ( 2.4 versus 2.0 hours ; NS ) .\
RESULTS	Benzodiazepine agonist effects of zolpidem were not altered by ritonavir .\
CONCLUSIONS	Short-term low-dose administration of ritonavir produces a large and significant impairment of triazolam clearance and enhancement of clinical effects .\
CONCLUSIONS	In contrast , ritonavir produced small and clinically unimportant reductions in zolpidem clearance .\
CONCLUSIONS	The findings are consistent with the complete dependence of triazolam clearance on CYP3A activity , compared with the partial dependence of zolpidem clearance on CYP3A .\
\
###24052453\
BACKGROUND	Alcohol use disorder is one of the leading causes of disability worldwide .\
BACKGROUND	Despite the availability of efficacious treatments , few individuals with an alcohol use disorder are actively engaged in treatment .\
BACKGROUND	Available evidence suggests that primary care may play a crucial role in the identification of patients with an alcohol use disorder , delivery of interventions , and the success of treatment .\
OBJECTIVE	The principal aims of this study were to test the effectiveness of a primary care-based Alcohol Care Management ( ACM ) program for alcohol use disorder and treatment engagement in veterans .\
METHODS	The design of the study was a 26-week single-blind randomized clinical trial .\
METHODS	The study was conducted in the primary care practices at three VA medical centers .\
METHODS	Participants were randomly assigned to treatment in ACM or standard treatment in a specialty outpatient addiction treatment program .\
METHODS	One hundred and sixty-three alcohol-dependent veterans were randomized .\
METHODS	ACM focused on the use of pharmacotherapy and psychosocial support .\
METHODS	ACM was delivered in-person or by telephone within the primary care clinic .\
METHODS	Engagement in treatment and heavy alcohol consumption .\
RESULTS	The ACM condition had a significantly higher proportion of participants engaged in treatment over the 26weeks [ OR = 5.36 , 95 % CI = ( 2.99 , 9.59 ) ] .\
RESULTS	The percentage of heavy drinking days were significantly lower in the ACM condition [ OR = 2.16 , 95 % CI = ( 1.27 , 3.66 ) ] , while overall abstinence did not differ between groups .\
CONCLUSIONS	Results demonstrate that treatment for an alcohol use disorder can be delivered effectively within primary care , leading to greater rates of engagement in treatment and greater reductions in heavy drinking .\
\
###23801867\
OBJECTIVE	To assess the impact of fast-track surgery ( FTS ) on hospital stay , cost of hospitalization and complications after radical total gastrectomy .\
METHODS	A randomized , controlled clinical trial was conducted from November 2011 to August 2012 in the Department of Digestive Surgery , Xijing Hospital of Digestive Diseases , the Fourth Military Medical University .\
METHODS	A total of 122 gastric cancer patients who met the selection criteria were randomized into FTS and conventional care groups on the first day of hospitalization .\
METHODS	All patients received elective standard D2 total gastrectomy .\
METHODS	Clinical outcomes , including duration of flatus and defecation , white blood cell count , postoperative pain , duration of postoperative stay , cost of hospitalization and complications were recorded and evaluated .\
METHODS	Two specially trained doctors who were blinded to the treatment were in charge of evaluating postoperative outcomes , discharge and follow-up .\
RESULTS	A total of 119 patients finished the study , including 60 patients in the conventional care group and 59 patients in the FTS group .\
RESULTS	Two patients were excluded from the FTS group due to withdrawal of consent .\
RESULTS	One patient was excluded from the conventional care group because of a non-resectable tumor .\
RESULTS	Compared with the conventional group , FTS shortened the duration of flatus ( 79.03 20.26 h vs 60.97 24.40 h , P = 0.000 ) and duration of defecation ( 93.03 27.95 h vs 68.00 25.42 h , P = 0.000 ) , accelerated the decrease in white blood cell count [ P < 0.05 on postoperative day ( POD ) 3 and 4 ] , alleviated pain in patients after surgery ( P < 0.05 on POD 1 , 2 and 3 ) , reduced complications ( P < 0.05 ) , shortened the duration of postoperative stay ( 7.10 2.13 d vs 5.68 1.22 d , P = 0.000 ) , reduced the cost of hospitalization ( 43783.25 8102.36 RMB vs 39597.62 7529.98 RMB , P = 0.005 ) , and promoted recovery of patients .\
CONCLUSIONS	FTS could be safely applied in radical total gastrectomy to accelerate clinical recovery of gastric cancer patients .\
\
###12709636\
BACKGROUND	In immunosuppressed patients with acute respiratory insufficiency ( ARI ) mechanical ventilation is associated with a high mortality .\
BACKGROUND	Therefore , in this situation , avoidance of intubation could be an important objective .\
BACKGROUND	However , experience of non-invasive ventilation ( NIV ) in the immunosuppressed remains limited .\
BACKGROUND	The first descriptive studies have shown that NIV could be an alternative to intubation , particularly in patients with malignant haematological disorders .\
BACKGROUND	In a prospective randomised controlled study Antonelli et al. showed that the use of NIV significantly improved the prognosis of patients with ARI following organ transplantation .\
BACKGROUND	We have carried out a prospective randomised controlled trial in 52 immunosuppressed patients to determine whether NIV improved the prognosis in patients admitted to intensive care with pulmonary infiltrates , fever and ARI .\
BACKGROUND	The use of NIV was associated with significant reductions in the intubation rate , serious complications and ICU and hospital mortality .\
CONCLUSIONS	Further studies are needed in order to better define the patients susceptible to benefit from NIV , and to establish variables predictive of the success or the failure of the method .\
CONCLUSIONS	NIV leads to an improvement in the prognosis of some immunosuppressed patients admitted to intensive care .\
\
###9590315\
OBJECTIVE	To compare the effects of isocaloric , isonitrogenous carbohydrate nutrition vs. lipid-based total parenteral nutrition on respiratory gas exchange and intermediary metabolism in critically ill patients .\
METHODS	Prospective , clinical trial .\
METHODS	Surgical intensive care unit in a major university hospital in Switzerland .\
METHODS	Sixteen patients admitted to the surgical intensive care unit .\
METHODS	Patients were randomized to receive isocaloric isonitrogenous total parenteral nutrition ( TPN ) containing 75 % ( TPN-glucose ) or 15 % ( TPN-lipid ) glucose over a 5-day period .\
RESULTS	Indirect glucose metabolism was assessed from plasma carbon-13 ( 13C ) - labeled glucose and 13C-labeled CO2 production during a tracer infusion of uniformly 13C-labeled glucose , and de novo lipogenesis was estimated from the incorporation of 13C into palmitate-very low density lipoproteins ( VLDL ) during a tracer infusion of 1 - ( 13 ) C acetate .\
RESULTS	Compared with TPN-lipid , TPN-glucose increased plasma glucose more ( by 26 % vs. 7 % , p < .05 ) , increased insulin more ( by 284 % vs. 40 % , p < .01 ) , and increased total CO2 more ( by 15 % vs. 0 % , p < .01 ) .\
RESULTS	Both nutrient mixtures failed to inhibit endogenous glucose production and net protein oxidation , suggesting absence of suppression of gluconeogenesis .\
RESULTS	Fractional de novo lipogenesis was markedly increased by TPN-glucose to 17.4 % vs. 3.3 % with TPN lipids .\
CONCLUSIONS	The rate of glucose administration commonly used during TPN of critically ill patients does not suppress endogenous glucose production or net protein loss , but markedly stimulates de novo lipogenesis and CO2 production .\
CONCLUSIONS	Increasing the proportion of fat may be beneficial , provided that lipid emulsion has no adverse effects .\
\
###24478399\
OBJECTIVE	This study sought to identify the profile of circulating microRNAs ( miRNAs ) in type 2 diabetes ( T2D ) and its response to changes in insulin sensitivity .\
METHODS	The circulating miRNA profile was assessed in a pilot study of 12 men : 6 with normal glucose tolerance ( NGT ) and 6 T2D patients .\
METHODS	The association of 10 circulating miRNAs with T2D was cross-sectionally validated in an extended sample of 45 NGT vs. 48 T2D subjects ( 65 nonobese and 28 obese men ) and longitudinally in 35 T2D patients who were recruited in a randomized , double-blinded , and placebo-controlled 3-month trial of metformin treatment .\
METHODS	Circulating miRNAs were also measured in seven healthy volunteers before and after a 6-h hyperinsulinemic-euglycemic clamp and insulin plus intralipid/heparin infusion .\
RESULTS	Cross-sectional studies disclosed a marked increase of miR-140-5p , miR-142-3p , and miR-222 and decreased miR-423-5p , miR-125b , miR-192 , miR-195 , miR-130b , miR-532-5p , and miR-126 in T2D patients .\
RESULTS	Multiple linear regression analyses revealed that miR-140-5p and miR-423-5p contributed independently to explain 49.5 % ( P < 0.0001 ) of fasting glucose variance after controlling for confounders .\
RESULTS	A discriminant function of four miRNAs ( miR-140-5p , miR-423-5p , miR-195 , and miR-126 ) was specific for T2D with an accuracy of 89.2 % ( P < 0.0001 ) .\
RESULTS	Metformin ( but not placebo ) led to significant changes in circulating miR-192 ( 49.5 % ; P = 0.022 ) , miR-140-5p ( -15.8 % ; P = 0.004 ) , and miR-222 ( -47.2 % ; P = 0.03 ) , in parallel to decreased fasting glucose and HbA1c .\
RESULTS	Furthermore , while insulin infusion during clamp decreased miR-222 ( -62 % ; P = 0.002 ) , the intralipid/heparin mixture increased circulating miR-222 ( 163 % ; P = 0.015 ) and miR-140-5p ( 67.5 % ; P = 0.05 ) .\
CONCLUSIONS	This study depicts the close association between variations in circulating miRNAs and T2D and their potential relevance in insulin sensitivity .\
\
###20224060\
OBJECTIVE	The modified Rankin Scale ( mRS ) is a popular primary stroke outcome measure , but its usefulness is limited by suboptimal reliability ( inter-rater agreement ) .\
METHODS	We developed and tested the reliability of a simplified mRS questionnaire ( smRSq ) in 50 patients after stroke seen in outpatient clinics .\
METHODS	Randomly chosen paired raters administered the smRSq within 20 minutes of each other and the ratings were blinded until the end of this study .\
RESULTS	Agreement among the raters was 78 % , the kappa statistic was 0.72 ( 95 % CI , 0.58-0 .86 ) , and the weighted kappa ( w ) statistic taking into account the extent of disagreement was 0.82 ( 95 % CI , 0.72-0 .92 ) .\
RESULTS	The average time to administer the smRSq was 1.67 minutes .\
CONCLUSIONS	The smRSq appears to have very good reliability that is similar to that of a structured interview mRS and is considerably less time-consuming .\
\
###15766997\
BACKGROUND	Neonatal mortality is the biggest contributor to global mortality of children younger than 5 years , and low birthweight is a crucial underlying factor .\
BACKGROUND	We tested the hypotheses that antenatal multiple micronutrient supplementation would increase infant birthweight and gestational duration .\
METHODS	We did a double-blind , randomised controlled trial in Dhanusha district , Nepal .\
METHODS	Women attending for antenatal care with singleton pregnancies at up to 20 weeks ' gestation were invited to participate .\
METHODS	Participants were randomly allocated either routine iron and folic acid supplements ( control ; n = 600 ) or a multiple micronutrient supplement providing a recommended daily allowance of 15 vitamins and minerals ( intervention ; n = 600 ) .\
METHODS	Supplementation began at a minimum of 12 weeks ' gestation and continued until delivery .\
METHODS	Primary outcome measures were birthweight and gestational duration .\
METHODS	Analysis was by intention to treat .\
METHODS	The study is registered as an International Standard Randomised Controlled Trial , number ISRCTN88625934 .\
RESULTS	Birthweight was available for 523/600 infants in the control group and 529/600 in the intervention group .\
RESULTS	Mean birthweight was 2733 g ( SD 422 ) in the control group and 2810 g ( 453 ) in the intervention group , representing a mean difference of 77 g ( 95 % CI 24-130 ; p = 0.004 ) and a relative fall in the proportion of low birthweight by 25 % .\
RESULTS	No difference was recorded in the duration of gestation ( 0.2 weeks [ -0.1 to 0.4 ] ; p = 0.12 ) , infant length ( 0.3 cm [ -0.1 to 0.6 ] ; p = 0.16 ) , or head circumference ( 0.2 cm [ -0.1 to 0.4 ] ; p = 0.18 ) .\
CONCLUSIONS	In a poor community in Nepal , consumption of a daily supplement containing a recommended daily allowance of 15 micronutrients in the second and third trimesters of pregnancy was associated with increased birthweight when compared with a standard iron and folic acid preparation .\
CONCLUSIONS	The effects on perinatal morbidity and mortality need further comparisons between studies .\
CONCLUSIONS	Published online March 3 , 2005 http://image.thelancet.com/extras/04art11045web.pdf .\
\
###11990445\
BACKGROUND	The combination of bone replacement graft materials has been suggested for the treatment of periodontal osseous defects .\
BACKGROUND	The purpose of this study was to evaluate the effectiveness of enamel matrix derivative ( EMD ) combined with a bovine-derived xenograft ( BDX ) as compared to EMD alone in the treatment of intraosseous defects in patients with moderate to advanced periodontitis .\
METHODS	Sixteen adult patients with at least 2 intrabony defects were entered in this split-mouth design study .\
METHODS	Defects were treated with EMD alone or EMD + BDX .\
METHODS	Reentries were performed 6 to 8 months after initial surgery .\
METHODS	The following soft and hard tissue measurements were recorded prior to initial surgery and at reentry : probing depth ( PD ) , gingival margin location , clinical attachment level ( CAL ) , depth of defect , and crestal bone level .\
METHODS	Statistical analyses were performed to determine changes in PD , CAL , fill of osseous defect , and crestal resorption .\
METHODS	Percentages of bone fill ( % BF ) and defect resolution ( % DR ) were also calculated .\
RESULTS	The most significant results were that gingival recession was greater for the group treated with EMD alone ( 0.8 + / - 0.8 mm ) compared to EMD + BDX ( 0.3 + / - 0.6 mm ) ( P = 0.04 ) and bone fill was greater for EMD + BDX ( 4.0 + / - 0.8 mm ) compared to EMD alone ( 3.1 + / - 1.0 mm ) ( P = 0.02 ) .\
RESULTS	The measures for PD reduction , attachment level gain , crestal resorption , % BF , and % DR did not present a statistically significant difference ( P > 0.10 ) .\
CONCLUSIONS	This study evaluated the performance of EMD + BDX and EMD alone .\
CONCLUSIONS	The results demonstrated that a significant improvement in clinical parameters was observed .\
CONCLUSIONS	When comparing both modalities , a statistically significant difference was only found for gingival recession and bone fill , yielding a more favorable outcome towards the combined approach .\
\
###25541333\
OBJECTIVE	Chronic pain and progressive loss of physical function with AS may adversely affect health-related quality of life ( HRQoL ) .\
OBJECTIVE	The objective of this study was to assess the 5-year data regarding spinal mobility , physical function and HRQoL in patients with AS who participated in the Adalimumab Trial Evaluating Long-term Efficacy and Safety for AS ( ATLAS ) study .\
METHODS	Patients received blinded adalimumab 40 mg or placebo every other week for 24 weeks , then open-label adalimumab for up to 5 years .\
METHODS	Spinal mobility was evaluated using linear BASMI ( BASMIlin ) .\
METHODS	BASDAI , total back pain , CRP , BASFI , Short Form-36 and AS quality of life ( ASQoL ) were also assessed .\
METHODS	Correlations between BASMIlin and clinical , functional and ASQoL outcomes after 12 weeks and after 5years of adalimumab exposure were evaluated using Spearman 's rank correlation .\
METHODS	Associations were further analysed using multivariate regression .\
RESULTS	Three hundred and eleven patients received 1 dose of adalimumab ; 125 of the 208 patients originally randomized to adalimumab received treatment for 5 years .\
RESULTS	Improvements in BASMIlin were sustained through 5 years , with a mean change of -0.6 from baseline in the population who completed 5 years of treatment with adalimumab .\
RESULTS	Improvements in disease activity , physical function and ASQoL were also sustained through 5 years .\
RESULTS	BASMIlin was significantly correlated with all evaluated clinical outcomes ( P < 0.001 ) .\
RESULTS	The highest correlation was with BASFI at 12 weeks ( r = 0.52 ) and at 5 years ( r = 0.65 ) .\
RESULTS	Multivariate regression analysis confirmed this association ( P < 0.001 ) .\
CONCLUSIONS	Treatment with adalimumab for up to 5 years demonstrated sustained benefits in spinal mobility , disease activity , physical function and HRQoL in patients with active AS .\
CONCLUSIONS	Spinal mobility was significantly associated with short - and long-term physical function in these patients .\
BACKGROUND	Clinicaltrials.gov ; https://clinicaltrials.gov/NCT00085644 .\
\
###21226576\
BACKGROUND	Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media .\
METHODS	We randomly assigned 291 children 6 to 23 months of age , with acute otitis media diagnosed with the use of stringent criteria , to receive amoxicillin-clavulanate or placebo for 10 days .\
METHODS	We measured symptomatic response and rates of clinical failure .\
RESULTS	Among the children who received amoxicillin-clavulanate , 35 % had initial resolution of symptoms by day 2 , 61 % by day 4 , and 80 % by day 7 ; among children who received placebo , 28 % had initial resolution of symptoms by day 2 , 54 % by day 4 , and 74 % by day 7 ( P = 0.14 for the overall comparison ) .\
RESULTS	For sustained resolution of symptoms , the corresponding values were 20 % , 41 % , and 67 % with amoxicillin-clavulanate , as compared with 14 % , 36 % , and 53 % with placebo ( P = 0.04 for the overall comparison ) .\
RESULTS	Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo ( P = 0.02 ) .\
RESULTS	The rate of clinical failure -- defined as the persistence of signs of acute infection on otoscopic examination -- was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo : 4 % versus 23 % at or before the visit on day 4 or 5 ( P < 0.001 ) and 16 % versus 51 % at or before the visit on day 10 to 12 ( P < 0.001 ) .\
RESULTS	Mastoiditis developed in one child who received placebo .\
RESULTS	Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate .\
RESULTS	There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae .\
CONCLUSIONS	Among children 6 to 23 months of age with acute otitis media , treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination .\
CONCLUSIONS	( Funded by the National Institute of Allergy and Infectious Diseases ; ClinicalTrials.gov number , NCT00377260 . )\
\
###21795455\
BACKGROUND	Preadipocyte factor 1 ( pref-1 ) is increased in anorexia nervosa and is associated negatively with bone mineral density ( BMD ) .\
BACKGROUND	No previous studies exist on pref-1 in women with exercise-induced hypothalamic amenorrhea ( HA ) , which similar to anorexia nervosa , is an energy-deficiency state associated with hypoleptinemia .\
OBJECTIVE	Our objective was to evaluate whether pref-1 levels are also elevated and associated with low BMD and to assess whether leptin regulates pref-1 levels in women with HA .\
METHODS	Study 1 was a double-blinded , placebo-controlled randomized clinical trial of metreleptin administration in women with HA .\
METHODS	Study 2 was an open-label study of metreleptin administration in low physiological , supraphysiological , and pharmacological doses in healthy women volunteers .\
METHODS	At Beth Israel Deaconess Medical Center , 20 women with HA and leptin levels higher than 5 ng/ml and nine healthy control women participated in study 1 , and five healthy women participated in study 2 .\
METHODS	For study 1 , 20 HA subjects were randomized to receive either 0.08 mg/kg metreleptin ( n = 11 ) or placebo ( n = 9 ) .\
METHODS	For study 2 , five healthy subjects received 0.01 , 0.1 , and 0.3 mg/kg metreleptin in both fed and fasting conditions for 1 and 3 d , respectively .\
METHODS	Circulating pref-1 and leptin levels were measured .\
RESULTS	Pref-1 was significantly higher in HA subjects vs. controls ( P = 0.035 ) and negatively associated with BMD ( = -0.38 ; P < 0.01 ) and bone mineral content ( = -0.32 ; P < 0.05 ) .\
RESULTS	Metreleptin administration did not alter pref-1 levels in any study reported herein .\
CONCLUSIONS	Pref-1 is higher in HA subjects than controls .\
CONCLUSIONS	Metreleptin administration at low physiological , supraphysiological , and pharmacological doses does not affect pref-1 levels , suggesting that hypoleptinemia is not responsible for higher pref-1 levels and that leptin does not regulate pref-1 .\
\
###12392586\
OBJECTIVE	We investigated the repeatability of the forearm blood flow response to intra-arterial infusion of endothelin-1 ( ET-1 ) , assessed by venous occlusion - plethysmography .\
METHODS	In eight healthy men ( aged 18-50 years ) , on four separate occasions , ET-1 ( 2.5 or 10 pmol min-1 ) was infused for 120 min via a 27 SWG cannula sited in the brachial artery of the nondominant arm .\
METHODS	Each dose level was administered twice on consecutive visits .\
METHODS	The dose order was randomized .\
METHODS	Results are expressed as percentage change from baseline at 120 min ( mean + / - s.e. mean ) .\
RESULTS	ET-1 caused significant vasoconstriction ( P < 0.0001 anova ) at both doses ( 38 + / - 3 % , 2.5 pmol min-1 and 62 + / - 3 % , 10 pmol min-1 ; mean visit 1 and 2 ) .\
RESULTS	There was no difference in the response to either dose on repeated challenge .\
RESULTS	Responses appeared to be less variable when expressed as percentage change in the ratio of blood flow ( infused : noninfused ) in both arms than as percentage change in blood flow in the infused arm alone , as indicated by repeatability coefficients ( 15 % vs 21 % , 2.5 pmol min-1 and 11 % vs 13 % , 10 pmol min-1 ; ratio vs infused arm alone ) .\
CONCLUSIONS	We have shown dose-dependent vasoconstriction in the forearm vascular bed to intra-arterial infusion of ET-1 and that this response is less variable when expressed as percentage change in the ratio of forearm blood flow than percentage change in the infused arm .\
CONCLUSIONS	These data should also provide useful information to determine the power of early clinical pharmacology studies investigating the activity of endothelin receptor antagonists .\
\
###12501151\
OBJECTIVE	The purpose of the study was to evaluate the effects of sucralfate , ranitidine , and omeprazole use on incidence of ventilatory-associated pneumonia ( VAP ) and mortality in ventilated pediatric critical care patients .\
METHODS	This prospective study was conducted at the pediatric intensive care unit ( PICU ) between August 2000 and February 2002 .\
METHODS	A total of 160 patients who needed mechanical ventilation were randomized into 4 groups according to the computer-generated random number table : group ( S ) , ( n = 38 ) received sucralfate suspension 60 mg/kg/d in 4 doses via the nasogastric tube that was flushed with 10 mL of sterile water ; group ( R ) , ( n = 42 ) received ranitidine 2 mg/kg/d intravenously in 4 doses ; group ( O ) , ( n = 38 ) received omeprazole 1 mg/kg/d intravenously in 2 doses ; and group ( P ) , ( n = 42 ) did not receive any medication for stress ulcer prophylaxis .\
METHODS	Treatment was begun within 6 hours of PICU admission .\
RESULTS	Seventy patients ( 44 % ) developed VAP .\
RESULTS	VAP rate was 42 % ( 16 of 38 ) in the sucralfate group , 48 % ( 20 of 42 ) in the ranitidine group , 45 % ( 17 of 38 ) in the omeprazole group , and 41 % ( 17 of 42 ) in the nontreated group .\
RESULTS	Overall mortality rate was 22 % ( 35 of 160 ) ; it was 21 % ( 8 of 38 ) in the sucralfate group , 23 % ( 10 of 42 ) in the ranitidine group , 21 % ( 8 of 38 ) in the omeprazole group , and 21 % ( 9 of 42 ) in the nontreated group .\
RESULTS	Our results did not show any difference in the incidence of VAP and mortality in mechanically ventilated PICU patients treated with ranitidine , omeprazole , or sucralfate , or nontreated subjects ( P = .963 , confidence interval [ CI ] = 0.958-0 .968 ; P = .988 , CI = 0.985-0 .991 , respectively ) .\
RESULTS	Nine patients ( 5.6 % ) had macroscopic bleeding .\
RESULTS	There was no statistically significant difference in macroscopic bleeding between groups .\
CONCLUSIONS	Our results did not show any difference in the incidence of VAP , macroscopic stress ulcer bleeding , and mortality in the mechanically ventilated PICU patients treated with ranitidine , omeprazole , or sucralfate , or nontreated subjects .\
CONCLUSIONS	None of the treatment regimens increased VAP compared with the nontreated group .\
CONCLUSIONS	Because there is insufficient data about stress ulcer prophylaxis and VAP in the pediatric age group , more studies with larger numbers of patients are needed .\
\
###15011930\
OBJECTIVE	To examine cognitive responses to a 4-month health promotion program targeting diet and physical activity in recently cohabiting couples .\
METHODS	A three-group randomized controlled trial : no intervention ( Controls ) , interactive group sessions and mail-outs ( Interactive ) , and one group session followed by mail-outs ( Mail ) .\
METHODS	Australian research studies unit .\
METHODS	Seventy-eight of 137 couples cohabiting for < 2 years , recruited by advertising , completed the study .\
METHODS	Stages of change ; health beliefs ; self-efficacy ; and perceived barriers to change evaluated by questionnaires at baseline , postintervention , and 1-year follow-up .\
METHODS	Data were analyzed using mixed models , factor analysis , and linear regression .\
RESULTS	In the Mail group , the perceived importance of barriers to dietary change decreased by 19 % at postintervention and 16 % at 1-year follow-up ; dietary self-efficacy increased by 9 % and 3 % , respectively .\
RESULTS	In the Interactive group , the perceived importance of barriers to dietary change decreased by 26 % and 20 % , and dietary self-efficacy increased by 14 % and 12 % , respectively .\
RESULTS	Similar trends for physical activity were not statistically significant .\
RESULTS	However , changes in self-efficacy and perceived barriers to change significantly predicted dietary and physical activity behaviors .\
RESULTS	A preponderance of higher socio-economic groups and the proportion of drop-out may have biased results .\
CONCLUSIONS	Health promotion using partners ' support and targeting diet and physical activity improves associated cognitive variables in couples .\
CONCLUSIONS	Most improvements were greater and more sustained with interactive group sessions .\
\
###8874325\
OBJECTIVE	To evaluate the quality-of-life effects of adjuvant high-dose interferon alfa-2b ( IFN alpha 2b ) treatment of high-risk melanoma .\
METHODS	A quality-of-life-adjusted survival analysis ( Quality-Adjusted Time Without Symptoms , and Toxicity [ Q-TWiST ] ) was applied to the Eastern Cooperative Oncology Group Trial E1684 , which compared high-dose IFN alpha 2b treatment for 1 year versus observation in 280 high-risk patients .\
METHODS	IFN alpha 2b was administered at a dosage of 20 mU/m2 intravenously daily for 5 days per week for 4 weeks , and then three times weekly at 10 mU/m2 subcutaneously for 48 weeks .\
RESULTS	After 84 months of median follow-up time , the IFN alpha 2b group gained a mean of 8.9 months without disease relapse ( P = .03 ) and 7.0 months of overall survival ( P = .07 ) as compared with the observation group , but had severe treatment-related toxicity for 5.8 months , on average .\
RESULTS	The IFN alpha 2b group had more quality-of-life-adjusted time than the observation group regardless of the relative valuations placed on time with toxicity ( Tox ) and time with relapse ( Rel ) .\
RESULTS	This gain was significant ( P < .05 ) for patients who consider Tox to have a high relative value and Rel to have a low relative value .\
RESULTS	In contrast , for patients who value Tox about the same as Rel , the quality-adjusted gain for IFN alpha 2b was not statistically significant .\
RESULTS	An analysis stratified according to tumor burden indicated that the benefit of IFN alpha 2b was greatest in the node-positive strata .\
CONCLUSIONS	For patients with high-risk melanoma , the clinical benefits of high-dose IFN alpha 2b can offset the toxic effects .\
CONCLUSIONS	The optimal treatment for an individual patient depends on the patient 's tumor burden and preferences regarding toxicity and disease relapse .\
\
###15343157\
BACKGROUND	While the formation of the dentin/adhesive hybrid layer has been generally established , the infiltration and flow of the adhesive resin inside the acid treated dentinal tubules remains controversial .\
OBJECTIVE	The aim of the present study was to investigate and review the current interpretation of resin tags by means of scanning electron microscopic ( SEM ) observation .\
METHODS	Eight noncarious , human third molars were cut transversally and then longitudinally to obtain 8 middle-to-deep dentinal surfaces .\
METHODS	The dentin was etched with 37 % phosphoric acid ( H 3 PO 4 ) gel for 10 seconds and then rinsed with water for 20 seconds .\
METHODS	The dentin was kept moist by removing the excess water with a damp cotton pellet .\
METHODS	The conditioned dentin was treated with a dentin bonding agent ( Single Bond ) and was light-polymerized for 20 seconds .\
METHODS	A 0.2 - to 0.5-mm layer of flowable composite ( Tetric Flow ) was then applied to the bonded dentin followed by 2 layers ( 2 mm each ) of composite ( Z 250 ) .\
METHODS	Each composite was light-polymerized for 40 seconds .\
METHODS	Subsequently , the specimens were cut lengthwise into 2 halves and randomly divided into 4 groups ( n = 4 ) , according to the surface preparation modality of the sectioned surface : Group EA : ethylenediamine tetraacetic acid , Group PA3 : H 3 PO 4 , Group PA120 : H 3 PO 4 + NaOCl , and Group CA : HCl + NaOCl .\
METHODS	Two additional teeth ( Group N ) were cut lengthwise into 2 halves and served as the control .\
METHODS	The sectioned surfaces were treated with HCl and NaOCl .\
METHODS	All specimens were processed for SEM observation .\
RESULTS	Specimens from Groups EA , PA3 , PA120 , CA , and N showed filamentous structures that were tens of microns long .\
RESULTS	Some filaments presented split-ends with hollow structures and very thin walls .\
RESULTS	Others made sharp hairpin turns indicating they were soft and compliant .\
CONCLUSIONS	Conventional SEM techniques , which are currently used to detect resin tags , actually identified filamentous organic structures , supposedly glycosaminoglycans , which were resistant to conventional specimen preparation techniques .\
CONCLUSIONS	The organic component showed a strong resemblance to the lamina limitans contained within the dentinal tubules .\
CONCLUSIONS	Over-reliance on SEM morphology has led to much confusion about the depth of penetration of resin tags .\
\
###18191090\
OBJECTIVE	To evaluate the effect of the blue light-filter intraocular lenses ( IOLs ) in vitrectomy combined with cataract surgery , focusing on the surgeon 's ability to perform specific vitreoretinal procedures and on the patients ' outcome .\
METHODS	Randomized clinical trial .\
METHODS	Sixty patients , recruited from our outpatient department , were assigned randomly to receive an ultraviolet-filter IOL ( clear IOL group ) or a blue light-filter IOL ( yellow IOL group ) combined with a vitreoretinal procedure .\
METHODS	Main outcome measures were intraoperative conditions for the surgeon and the functional outcome .\
METHODS	Second outcome measures were complication rates and vitreoretinal diagnoses .\
RESULTS	The questionnaire responses showed that the blue light-filter IOLs did not represent an impediment to vitreoretinal surgery ( P > .05 ) .\
RESULTS	No intraoperative complications were encountered in either group .\
RESULTS	Patients in both IOL groups showed comparable functional results with respect to visual acuity , contrast sensitivity , color vision , and glare effect ( P > .05 ) .\
RESULTS	The functional outcome was influenced significantly by the vitreoretinal diagnosis ( P < .01 ) .\
CONCLUSIONS	With the possible advantage of macular protection and no intraoperative or functional disadvantage , the routine use of the blue light-filter IOL in combined surgery can be recommended .\
\
###22687642\
OBJECTIVE	Arachidonic acid-derived eicosanoids ( lipoxins and 15-epilipoxins ) have a major role in resolution of inflammation .\
OBJECTIVE	15-epi-lipoxin A ( 4 ) ( 15-epi-LXA ( 4 ) ) is a lipid mediator with strong anti-inflammatory and inflammation-resolving effects .\
OBJECTIVE	We examined the effect of pioglitazone therapy on plasma 15-epi-LXA ( 4 ) in patients with type 2 diabetes ( T2DM ) .\
METHODS	T2DM patients ( Age = 56 2 y , BMI = 33 1.8 , HbA1c = 7.8 0.3 % ) not on thiazolidinedione therapy for at least 12 months were randomized to receive either pioglitazone 15 mg/daily for two months ( PIO 15 ) or pioglitazone 15 mg/day for one month followed by a dose escalation to 30 mg/day for an additional one month ( PIO 30 ) .\
RESULTS	PIO 15 increased plasma 15-epi-LXA ( 4 ) levels ( 0.63 0.06-1 .05 0.08 ng/mL , p < 0.01 ) and adiponectin levels ( 6.4 0.3-10 .1 0.7 g/mL , p < 0.001 ) and decreased fasting plasma glucose ( 125 8-106 9 mg/dL , p < 0.05 ) , free fatty acids ( FFA ) ( 414 46-320 38 mol/l , p < 0.05 ) and HOMA-IR ( 5.3 0.4 to 4.0 0.4 , p < 0.05 ) .\
RESULTS	Body weight ( = 0.2 kg ) and HbA1c ( 7.4 0.2-7 .1 0.2 % ) did not change significantly .\
RESULTS	PIO 30 treated patients had similar increase in plasma 15-epi-LXA ( 4 ) ( 0.64 0.10-1 .08 0.09 ng/mL , p < 0.01 ) , and decrease in plasma FFA ( 423 42-317 40 mol/l , p < 0.05 ) despite a greater increase in plasma adiponectin ( 6.5 0.4-15 .5 0.7 ug/mL , p < 0.001 ) and a greater reduction in HbA1c ( 8.7 0.5-7 .4 0.3 % , p < 0.01 ) , FPG ( 159 16-120 10 mg/dL , p < 0.01 ) , and HOMA-IR ( 6.6 0.8-4 .4 0.4 , p < 0.005 ) .\
RESULTS	Furthermore , PIO 30 treated patients had a significant increase in body weight ( = 1.7 kg , p < 0.02 ) .\
CONCLUSIONS	In T2DM , low dose pioglitazone ( 15 mg/day ) increases 15-epi-LXA ( 4 ) and adiponectin levels in the absence of significant changes in body weight .\
CONCLUSIONS	Dose escalation of pioglitazone to 30 mg/day is associated with a similar increase in 15-epi-LXA ( 4 ) despite a greater increase in plasma adiponectin concentrations .\
\
###12742839\
BACKGROUND	Ketotifen fumarate blocks histamine1 ( H1 ) receptors , stabilizes mast cells , and acts as an eosinophil inhibitor ( decreases chemotaxis and activation of eosinophils ) .\
OBJECTIVE	To assess the efficacy of ketotifen 0.025 % ophthalmic solution in the prevention of symptoms of allergic conjunctivitis , using the conjunctival allergen challenge model .\
METHODS	This was a single-center , double-masked , randomized , placebo-controlled , contralateral-eye comparison , allergen challenge trial conducted in the United States .\
METHODS	Subjects were randomized to receive ketotifen 0.025 % in one eye and placebo in the other .\
METHODS	At visits 1 and 2 , allergen challenges were performed to determine the allergen concentration eliciting a qualifying reaction for each subject .\
METHODS	At the 3 subsequent visits , subjects received 1 drop of ketotifen 0.025 % ophthalmic solution in one eye and vehicle solution as placebo in the other eye 15 minutes ( visit 3 ) , 6 hours ( visit 4 ) , and 8 hours ( visit 5 ) before allergen challenge .\
METHODS	The primary efficacy measure was the subject 's rating of itching at 3 , 7 , and 10 minutes after challenge .\
RESULTS	Of the 89 subjects randomly assigned to masked trial medication at visit 3 , 72 completed the study .\
RESULTS	At visits 3 , 4 , and 5 , mean itching scores were significantly better for ketotifen-treated eyes at all postchallenge time points , compared with placebo ( P < .001 ) .\
RESULTS	Also at visits 3 , 4 , and 5 , ketotifen was statistically superior to placebo in reducing ocular hyperemia at all postchallenge time points ( P < .05 ) .\
CONCLUSIONS	Ketotifen was safe and statistically effective in reducing ocular itching and hyperemia associated with allergic conjunctivitis .\
CONCLUSIONS	Ketotifen 's rapid onset of action ( within 15 minutes ) and extended duration of action ( at least 8 hours ) make it a valuable treatment for allergic conjunctivitis .\
\
###18652320\
OBJECTIVE	To observe clinical therapeutic effect of catgut implantation at Shu - and Mu-acupoints of liver , spleen and kidney on premature ovarian failure .\
METHODS	One hundred and thirty-two cases of premature ovarian failure were randomly divided into a catgut implantation group and a medication group , 66 cases in each group .\
METHODS	The catgut implantation group were treated by catgut implantation at She - and Mu-acupoints of liver , spleen and kidney , and the medication group were treated with oral administration of Estradiol Valerate 2 mg , qd , for 20 days , and 10 days later , Medroxyprogesterone Acetate 4 mg was added , b. i. d , for 10 days , averaging 6 months of medication .\
METHODS	The therapeutic effects and changes of serum follicle-stimulating hormone ( FSH ) and estradiol ( E2 ) were observed in the two groups .\
RESULTS	After treatment , serum FSH and E2 significantly improved in the two groups ( P < 0.01 ) , with the serum E2 in the catgut implantation group increased more significantly than that in the medication group ( P < 0.01 ) .\
RESULTS	The cured rate and the total effective rate were 84.9 % and 97.0 % in the catgut implantation group and 31.8 % and 84.8 % in the medication group , the cured rate in the catgut implantation group being better than that in the medication group ( P < 0.05 ) .\
RESULTS	Ten month later , the therapeutic effect in the catgut implantation group was kept .\
CONCLUSIONS	Catgut implantation at Shu - and Me-acupoints of liver , spleen and kidney has a good therapeutic effect on premature ovarian failure with no side effect .\
\
###20683319\
BACKGROUND	Early integration of HIV proviral DNA into the host cell genome prevents viral eradication , despite suppressive HAART .\
BACKGROUND	In vitro , integrase inhibitors reduce proviral DNA levels and rapidly increase 2-long-terminal repeat ( LTR ) circle levels .\
BACKGROUND	We examined the effect of raltegravir on the time course of HIV-1 DNA forms in patients with controlled viremia .\
METHODS	The EASIER-ANRS 138 randomized trial demonstrated that switching from enfuvirtide to raltegravir maintained virological suppression in treatment-experienced patients with viral load below 400 copies/ml .\
METHODS	We analyzed total HIV-1 DNA and 2-LTR circle levels measured at weeks ( W ) 0 and 24 in the first 30 patients enrolled in each arm , and at W48 in the raltegravir arm .\
RESULTS	At W0 the total DNA level was 3.6 log ( 10 ) / 10 ( 6 ) peripheral blood mononuclear cell ( PBMC ) in both groups , and 2-LTR circles were detected in six patients ( median 89 copies/10 ( 6 ) PBMC ) .\
RESULTS	At W24 the total DNA level was 3.6 log ( 10 ) / 10 ( 6 ) PBMC in both groups , and 2-LTR circles were detected in three new patients .\
RESULTS	At W48 the total HIV DNA level in the raltegravir group was 3.5 log ( 10 ) / 10 ( 6 ) PBMC , and 2-LTR circles were undetectable .\
RESULTS	No significant change in total HIV DNA occurred between W0 and W24 in either arm ( P = 0.71 ) and no significant change was observed in the raltegravir arm at W48 .\
CONCLUSIONS	In most patients on effective HAART , including regimens containing an integrase inhibitor , the viral reservoir , reflected by the HIV-1 DNA load , is stable and nondynamic during the 48 weeks of follow-up .\
\
###21592370\
BACKGROUND	Weekly docetaxel has occasionally been used in the neoadjuvant to downstage breast cancer to reduce toxicity and possibly enhance quality of life .\
BACKGROUND	However , no studies have compared the standard three weekly regimen to the weekly regimen in terms of quality of life .\
BACKGROUND	The primary aim of our study was to compare the effects on QoL of weekly versus 3-weekly sequential neoadjuvant docetaxel .\
BACKGROUND	Secondary aims were to determine the clinical and pathological responses , incidence of Breast Conserving Surgery ( BCS ) , Disease Free Survival ( DFS ) and Overall Survival ( OS ) .\
METHODS	Eighty-nine patients receiving four cycles of doxorubicin and cyclophosphamide were randomised to receive twelve cycles of weekly docetaxel ( 33 mg/m2 ) or four cycles of 3-weekly docetaxel ( 100 mg/m2 ) .\
METHODS	The Functional Assessment of Cancer Therapy-Breast and psychosocial questionnaires were completed .\
RESULTS	At a median follow-up of 71.5 months , there was no difference in the Trial Outcome Index scores between treatment groups .\
RESULTS	During weekly docetaxel , patients experienced less constipation , nail problems , neuropathy , tiredness , distress , depressed mood , and unhappiness .\
RESULTS	There were no differences in overall clinical response ( 93 % vs. 90 % ) , pathological complete response ( 20 % vs. 27 % ) , and breast-conserving surgery ( BCS ) rates ( 49 % vs. 42 % ) .\
RESULTS	Disease-free survival and overall survival were similar between treatment groups .\
CONCLUSIONS	Weekly docetaxel is well-tolerated and has less distressing side-effects , without compromising therapeutic responses , Breast Conserving Surgery ( BCS ) or survival outcomes in the neoadjuvant setting .\
BACKGROUND	ISRCTN : ISRCTN09184069 .\
\
###21813223\
OBJECTIVE	The purpose of this study was to investigate the dose-dependent effects of propofol on cognitive function and muscle power as well as vital functions .\
METHODS	Twenty volunteers participated in this study .\
METHODS	Each subject underwent 2 experiments in a randomized crossover manner ( propofol group and control group ) .\
METHODS	After control data were obtained , propofol at predicted effect site concentrations of 0.4 , 0.8 , 1.2 , 1.6 , and 2.0 g/mL was infused in the propofol group using a target controlled infusion system .\
METHODS	Heart rate , noninvasive blood pressure , arterial oxygen saturation , respiratory rate , and bispectral index value were monitored .\
METHODS	Observer 's assessment of alertness/sedation and the correct answer rate of the Stroop color word test were assessed .\
METHODS	Muscle power , grip strength and bite force were measured .\
RESULTS	In the propofol group , the bispectral index value and observer 's assessment of alertness/sedation scale dose-dependently reduced .\
RESULTS	At the predicted effect site propofol concentration of 2.0 g/mL , 6 subjects became unconscious .\
RESULTS	The correct answer rate of Stroop color word test reduced at the predicted effect site propofol concentration of 1.6 and 2.0 g/mL .\
RESULTS	Grip strength slightly increased at the predicted effect site propofol concentration of 1.2 g/mL or less , and bite force dose-dependently increased .\
RESULTS	At the predicted effect site propofol concentration of 2.0 g/mL , both muscle powers began to decrease .\
RESULTS	Bite force dose-dependently increased and reached the maximum at the predicted effect site propofol concentration of 1.6 g/mL .\
CONCLUSIONS	Although the detailed mechanisms are unknown , propofol dose-dependently increases bite force during minimal and moderate sedation .\
\
###10476888\
BACKGROUND	The relationship between loss of radiographic alveolar bone height and probing attachment loss has been studied by a number of investigators , with mixed results .\
BACKGROUND	Recent studies have found weak correlations and have suggested that the relationship between bone loss and attachment loss is complex , perhaps because changes in bone height and attachment level are separated in time .\
METHODS	The 85 patients in this report were part of a prospective estrogen replacement interventional study .\
METHODS	All patients were in good oral health at entry and received annual oral prophylaxis as part of the study .\
METHODS	Standard probing measurements were made with a pressure-sensitive probe at 6 sites on each tooth .\
METHODS	Vertical bite-wing radiographs were taken of each patient , radiographs were digitized , and 6 linear measurements ( corresponding to probing site measurements ) were made from the cemento-enamel junction to the alveolar crest .\
METHODS	These procedures were performed at baseline and at annual intervals ; this study reports results after 2 years .\
METHODS	Data were analyzed both by individual site and by averaging identical sites from all measured teeth for each patient .\
RESULTS	Very weak direct relationships between change in alveolar bone height and change in attachment level were found in both the site data ( r2 = 0.0022 ; P = 0.189 ) and the patient average data ( r2 = 0.031 ; P = 0.104 ) .\
CONCLUSIONS	The changes in these patients were probably due to systemic changes in bone health rather than to periodontal disease .\
CONCLUSIONS	However , the weak correlations between changes in attachment level and bone height are similar to recent studies of periodontal disease .\
CONCLUSIONS	Our results support suggestions in the literature that the link between changes in attachment and alveolar bone height is complex , perhaps because changes in the 2 tissue types are separated by a considerable time delay .\
\
###20131040\
OBJECTIVE	To investigate the effects of acupuncture on the morphine-related side effects ( nausea , vomiting , itchiness and gastrointestinal disorders ) in patients undergoing anesthesia and analgesia and try to find the clinical mechanism of acupuncture .\
METHODS	Patients scheduled to have transurethral prostatic resection : enrolled in the study ( 69 patients ) , characterized as Grade II or III by the American Society of Anesthesiologists physical status classification , were randomly assigned to three groups , 23 patients in each group : the placebo group ( control group ) , non-anesthesia area ( NAA ) group , and the anesthesia area ( AA ) group .\
METHODS	After spinal anesthesia , all patients received Patients Controlled Epidural Analgesia .\
METHODS	The vital signs , bowel sounds , visual analogue scales , itchiness , nausea and vomiting , and time for first exhaust post operation were observed .\
RESULTS	Altogether , nine cases were eliminated , three in each group .\
RESULTS	Finally , sixty cases completed this study , : twenty in each group .\
RESULTS	There was a significant decrease of bowel sounds after morphine spinal anesthesia in the three groups .\
RESULTS	Compared with the control or AA group , the bowel sound recovered after acupuncture , the incidences of nausea and vomiting , itchiness , and time for first exhaust after operation decreased in the NAA group ( P < 0.05 ) .\
RESULTS	There was a significant decrease of the incidence for itchiness in the NAA group compared with < the control group ( P < 0.05 ) .\
CONCLUSIONS	On the basis of this study , it is obviously seen that acupuncture could : decrease the incidence of morphine-related side effects ( nausea and vomiting , itchiness and gastrointestinal disorders ) when the spinal cord conduct is normal .\
CONCLUSIONS	However , it decreases only the incidence of itchiness but not for gastrointestinal dysfunction when the spinal cord is blocked .\
\
###22174748\
BACKGROUND	Dexamethasone has been shown to reduce mortality in patients with tuberculous meningitis but the long-term outcome of the disease is unknown .\
METHODS	Vietnamese adults and adolescents with tuberculous meningitis recruited to a randomised , double-blind , placebo-controlled trial of adjunctive dexamethasone were followed-up at five years , to determine the effect of dexamethasone on long-term survival and neurological disability .\
RESULTS	545 patients were randomised to receive either dexamethasone ( 274 patients ) or placebo ( 271 patients ) .\
RESULTS	50 patients ( 9.2 % ) were lost to follow-up at five years .\
RESULTS	In all patients two-year survival , probabilities tended to be higher in the dexamethasone arm ( 0.63 versus 0.55 ; p = 0.07 ) but five-year survival rates were similar ( 0.54 versus 0.51 , p = 0.51 ) in both groups .\
RESULTS	In patients with grade 1 TBM , but not with grade 2 or grade 3 TBM , the benefit of dexamethasone treatment tended to persist over time ( five-year survival probabilities 0.69 versus 0.55 , p = 0.07 ) but there was no conclusive evidence of treatment effect heterogeneity by TBM grade ( p = 0.36 ) .\
RESULTS	The dexamethasone group had a similar proportion of severely disabled patients among survivors at five years as the placebo group ( 17/128 , 13.2 % vs. 17/116 , 14.7 % ) and there was no significant association between dexamethasone treatment and disability status at five years ( p = 0.32 ) .\
CONCLUSIONS	Adjunctive dexamethasone appears to improve the probability of survival in patients with TBM , until at least two years of follow-up .\
CONCLUSIONS	We could not demonstrate a five-year survival benefit of dexamethasone treatment which may be confined to patients with grade 1 TBM .\
BACKGROUND	ClinicalTrials.gov NCT01317654 .\
\
###23538044\
OBJECTIVE	The purpose of this study was to compare clinical outcomes after single-bundle anterior cruciate ligament ( ACL ) reconstruction with a free Achilles tendon allograft using either a transtibial or an anteromedial portal technique and then to quantify the difference in femoral tunnel position between these 2 approaches .\
OBJECTIVE	This assessment was to be performed with a new method using conventional magnetic resonance imaging ( MRI ) with a digital imaging system .\
METHODS	In this prospective randomized comparative study , 53 young male patients with ACL rupture underwent ACL reconstruction with the transtibial technique ( group 1 ) or the anteromedial portal technique ( group 2 ) .\
METHODS	We assessed clinical outcomes with the Lachman test , pivot shift test , International Knee Documentation Committee ( IKDC ) classification , Lysholm score , Tegner activity scale , and single leg hop ( SLH ) test .\
METHODS	Radiologic assessments included the position of the femoral tunnel aperture and the posterior cruciate ligament ( PCL ) index on conventional MRI and the side-to-side difference ( SSD ) on stress radiographs .\
RESULTS	Sixty-one participants had follow-up .\
RESULTS	The mean follow-up period was 30.2 months .\
RESULTS	At the last follow-up , there were no significant differences between the 2 groups in results from the Lachman test , pivot shift test , IKDC classification , Tegner activity scale , and SLH test .\
RESULTS	The Lysholm score and SSD results in group 2 were superior to those in group 1 ( P < .001 ) .\
RESULTS	The femoral tunnel aperture was positioned more posteriorly in group 2 than in group 1 ( P < .001 ) .\
RESULTS	Changes in the PCL index were greater in group 1 than in group 2 ( P < .001 ) .\
CONCLUSIONS	The position of the femoral tunnel aperture created with the anteromedial portal technique was more posterior than that made with the transtibial technique .\
CONCLUSIONS	Knees reconstructed with the anteromedial portal technique were more stable in Telos testing , and were 3 points higher on the Lysholm score .\
CONCLUSIONS	However , there were no statistically significant differences in the Tegner activity scale or IKDC classification between the 2 groups .\
METHODS	Therapeutic level I , randomized controlled clinical trial .\
\
###16274381\
OBJECTIVE	To determine the effects of ultra-low-dose hormone therapy on muscle mass and physical function in community-dwelling women .\
METHODS	Double-blind , placebo-controlled trial .\
METHODS	Clinical research center in Connecticut .\
METHODS	Healthy , community-dwelling women aged 65 and older ( n = 167 ) .\
METHODS	Eligible women were randomly assigned to treatment with 0.25 mg 17-beta estradiol or placebo for 36 months .\
METHODS	All women ( estradiol or placebo ) with an intact uterus received micronized progesterone 100 mg/d for 2 weeks every 6 months .\
METHODS	All participants received 1,300 mg elemental calcium with 1,000 IU vitamin D per day .\
METHODS	Appendicular skeletal muscle mass ( ASM ) , lean body mass ( LBM ) , and percentage body fat were measured using dual x-ray absorptiometry .\
METHODS	Sarcopenia was defined as skeletal muscle mass ( ASM/height2 ) 2 standard deviations or less than young , healthy reference population mean .\
METHODS	Physical activity ( Physical Activity Scale in the Elderly ( PASE ) ) and performance were measured .\
METHODS	Serum estrone , estradiol , and sex hormone-binding globulin were measured .\
RESULTS	The prevalence of sarcopenia at baseline was 13 % .\
RESULTS	There were no baseline differences between groups except for PASE score and chair rise time , in which the estrogen group had better performance .\
RESULTS	No changes in ASM , LBM , percentage of body fat , or physical performance were found after 3 years of estrogen therapy .\
CONCLUSIONS	Sarcopenia was present in 13 % of this group of community-dwelling , postmenopausal older women .\
CONCLUSIONS	Ultra-low-dose estrogen therapy neither improves nor harms ASM .\
CONCLUSIONS	Similarly , no changes in body fat or physical performance were detected .\
\
###22110169\
OBJECTIVE	We carried out a secondary analysis in high-risk patients with a previous myocardial infarction ( MI ) and diabetes in the Alpha Omega Trial .\
OBJECTIVE	We tested the hypothesis that in these patients an increased intake of the n-3 fatty acids eicosapentaenoic acid ( EPA ) , docosahexaenoic acid ( DHA ) , and - linolenic acid ( ALA ) will reduce the incidence of ventricular arrhythmias and fatal MI .\
METHODS	A subgroup of 1,014 post-MI patients with diabetes aged 60-80 years was randomly allocated to receive one of four trial margarines , three with an additional amount of n-3 fatty acids and one placebo for 40 months .\
METHODS	The end points were ventricular arrhythmia-related events and fatal MI .\
METHODS	The data were analyzed according to the intention-to-treat principle , using multivariable Cox proportional hazards models .\
RESULTS	The patients consumed on average 18.6 g of margarine per day , which resulted in an additional intake of 223 mg EPA plus 149 mg DHA and/or 1.9 g ALA in the active treatment groups .\
RESULTS	During follow-up , 29 patients developed a ventricular arrhythmia-related events and 27 had a fatal MI .\
RESULTS	Compared with placebo patients , the EPA-DHA plus ALA group experienced less ventricular arrhythmia-related events ( hazard ratio 0.16 ; 95 % CI 0.04-0 .69 ) .\
RESULTS	These n-3 fatty acids also reduced the combined end-point ventricular arrhythmia-related events and fatal MI ( 0.28 ; 0.11-0 .71 ) .\
CONCLUSIONS	Our results suggest that low-dose supplementation of n-3 fatty acids exerts a protective effect against ventricular arrhythmia-related events in post-MI patients with diabetes .\
\
###9295240\
BACKGROUND	Clozapine , a relatively expensive antipsychotic drug , is widely used to treat patients with refractory schizophrenia .\
BACKGROUND	It has a low incidence of extrapyramidal side effects but may cause agranulocytosis .\
BACKGROUND	There have been no long-term assessments of its effect on symptoms , social functioning , and the use and cost of health care .\
METHODS	We conducted a randomized , one-year , double-blind comparative study of clozapine ( in 205 patients ) and haloperidol ( in 218 patients ) at 15 Veterans Affairs medical centers .\
METHODS	All participants had refractory schizophrenia and had been hospitalized for the disease for 30 to 364 days in the previous year .\
METHODS	All patients received case-management and social-rehabilitation services , as clinically indicated .\
RESULTS	In the clozapine group , 117 patients ( 57 percent ) continued their assigned treatment for the entire year , as compared with 61 ( 28 percent ) of the patients in the haloperidol group ( P < 0.001 ) .\
RESULTS	As judged according to the Positive and Negative Syndrome Scale of Schizophrenia , patients in the clozapine group had 5.4 percent lower symptom levels than those in the haloperidol group at all follow-up evaluations ( mean score , 79.1 vs. 83.6 ; P = 0.02 ) .\
RESULTS	The differences on a quality-of-life scale were not significant in the intention-to-treat analysis , but they were significant among patients who did not cross over to the other treatment ( P = 0.003 ) .\
RESULTS	Over a one-year period , patients assigned to clozapine had fewer mean days of hospitalization for psychiatric reasons than patients assigned to haloperidol ( 143.8 vs. 168.1 days , P = 0.03 ) and used more outpatient services ( 133.6 vs. 97.9 units of service , P = 0.03 ) .\
RESULTS	The total per capita costs to society were high -- $ 58,151 in the clozapine group and $ 60,885 in the haloperidol group ( P = 0.41 ) .\
RESULTS	The per capita costs of antipsychotic drugs were $ 3,199 in the clozapine group and $ 367 in the haloperidol group ( P < 0.001 ) .\
RESULTS	Patients assigned to clozapine had less tardive dyskinesia and fewer extrapyramidal side effects .\
RESULTS	Agranulocytosis developed in three patients in the clozapine group ; all recovered fully .\
CONCLUSIONS	For patients with refractory schizophrenia and high levels of hospital use , clozapine was somewhat more effective than haloperidol and had fewer side effects and similar overall costs .\
\
###20143047\
OBJECTIVE	The objective of this study was to examine the effects of drug therapy alone and combined with behavioral therapy on urgency and 24-voiding frequency in women with urge-predominant incontinence and to identify predictors of change .\
METHODS	A planned analysis of data from a multi-site , randomized , controlled trial ( N = 307 ) .\
METHODS	Bladder diaries were used to document voids , incontinence , and urgency severity .\
RESULTS	Urgency scores decreased significantly within both treatment groups , but changes did not differ between groups ( p = 0.30 ) .\
RESULTS	Improvement in urgency was associated with greater baseline urgency ( p < 0.0001 ) and black ethnicity ( p = 0.03 ) .\
RESULTS	Voiding frequency increased with drug alone and decreased slightly with combined therapy ( p = 0.009 ) , and improvement was associated with combined treatment ( p < 0.0001 ) , higher baseline frequency ( p < 0.0001 ) , and lower baseline incontinence episode frequency ( p = 0.001 ) .\
CONCLUSIONS	Although combined drug and behavioral therapy does not appear to improve urgency more than drug alone , it resulted in better outcomes on voiding frequency .\
\
###25183313\
BACKGROUND	As current dengue control strategies have been shown to be largely ineffective in reducing dengue in school-aged children , novel approaches towards dengue control need to be studied .\
BACKGROUND	Insecticide-impregnated school uniforms represent an innovative approach with the theoretical potential to reduce dengue infections in school children .\
OBJECTIVE	This study took place in the context of a randomised control trial ( RCT ) to test the effectiveness of permethrin-impregnated school uniforms ( ISUs ) for dengue prevention in Chachoengsao Province , Thailand .\
OBJECTIVE	The objective was to assess the acceptability of ISUs among parents , teachers , and principals of school children involved in the trial .\
METHODS	Quantitative and qualitative tools were used in a mixed methods approach .\
METHODS	Class-clustered randomised samples of school children enrolled in the RCT were selected and their parents completed 321 self-administered questionnaires .\
METHODS	Descriptive statistics and logistic regression were used to analyse the quantitative data .\
METHODS	Focus group discussions and individual semi-structured interviews were conducted with parents , teachers , and principals .\
METHODS	Qualitative data analysis involved content analysis with coding and thematic development .\
RESULTS	The knowledge and experience of dengue was substantial .\
RESULTS	The acceptability of ISUs was high .\
RESULTS	Parents ( 87.3 % ; 95 % CI 82.9-90 .8 ) would allow their child to wear an ISU and 59.9 % ( 95 % CI 53.7-65 .9 ) of parents would incur additional costs for an ISU over a normal uniform .\
RESULTS	This was significantly associated with the total monthly income of a household and the educational level of the respondent .\
RESULTS	Parents ( 62.5 % ; 95 % CI 56.6-68 .1 ) indicated they would be willing to recommend ISUs to other parents .\
CONCLUSIONS	Acceptability of the novel tool of ISUs was high as defined by the lack of concern along with the willingness to pay and recommend .\
CONCLUSIONS	Considering issues of effectiveness and scalability , assessing acceptability of ISUs over time is recommended .\
\
###20439553\
OBJECTIVE	Concord grape juice ( CGJ ) is a rich source of phenolic antioxidants , with a range of putative health benefits .\
OBJECTIVE	However , high beverage energy and fructose intake may lead to weight gain and insulin resistance , respectively .\
OBJECTIVE	This study assessed the effects of CGJ consumption for 12 weeks on appetite , diet , body weight , lipid profile , and antioxidant status .\
METHODS	Seventy-six men and women aged 18 to 50 years with a body mass index of 25.0 to 29.9 kg/m ( 2 ) consumed either 480 mL CGJ , 480 mL substitute ( polyphenol-free ) grape-flavored drink ( SGD ) , or no beverage ( NTG ) daily for 12 weeks .\
METHODS	Anthropometric indices were measured biweekly , dietary intake and appetite were assessed 4 times during the study , and plasma oxygen radical absorbance capacity , lipids , and oral glucose tolerance were assessed at baseline and week 12 .\
RESULTS	Compared to baseline , the SGD group reported a reduction in fullness ( p < 0.005 ) and gained 1.6 kg ( p < 0.05 ) .\
RESULTS	No significant changes in body weight or composition were observed with CGJ or control ( no beverage added to diet ) .\
RESULTS	Mean dietary compensation was 98.8 % for SGD and 81.0 % for CGJ .\
RESULTS	Serum glucose and insulin area under the curve ( 180 minutes ) increased slightly , but this was significant only with CGJ .\
RESULTS	Plasma antioxidant capacity did not differ across groups , suggesting no effect of chronic CGJ ingestion on antioxidant status .\
CONCLUSIONS	Daily consumption of CGJ for 12 weeks did not lead to significant weight gain , but consumption of SGD did .\
CONCLUSIONS	The basis of this differential response could not be documented , but it is hypothesized to be a result of dietary compensation and effects of CGJ polyphenols on thermogenesis and substrate oxidation .\
\
###11450476\
BACKGROUND	Latanoprost effectively lowers intraocular pressure .\
BACKGROUND	Because ischemia has gained increasing importance in the pathogenesis of glaucoma , an antiglaucomatous drug should also be investigated with regard to the influence on ocular hemodynamics .\
METHODS	In a double masked , randomized , clinical trial , Latanoprost eye drops were administered to 15 volunteers once daily for 8 days and 15 further volunteers received placebo eye drops according to the same protocol .\
METHODS	IOP , blood pressure , heart rate , ocular pulse amplitudes , pulse volume , pulsatile ocular blood flow and contrast sensitivity were measured before ( 1T0 ) , 120 min after drop administration ( 1T120 ) , after 7 days of therapy ( 8T0 ) and again 120 min after an acute administration ( 8T120 ) .\
METHODS	For statistical analysis a two-way variance-analysis and the t-test for paired samples were used .\
RESULTS	IOP was found to be statistically significantly different comparing both groups over the test period ( p = 0.036 ) .\
RESULTS	In Latanoprost-treated subjects the t-test revealed a significant drop in IOP between 1T0 and 8T0 ( p = 0.009 ) and between 1T0 and 8T120 ( p < 0.0001 ) .\
RESULTS	All other above mentioned parameters remained constant .\
CONCLUSIONS	In Latanoprost-treated subjects , a significant drop in intraocular pressure was observed after 1 week .\
CONCLUSIONS	However , ocular perfusion and contrast sensitivity did not change during therapy .\
CONCLUSIONS	This might be due to an effective autoregulation in healthy volunteers .\
\
###10735462\
OBJECTIVE	To determine the haemodynamic effects of dopamine and volume expansion in preterm neonates .\
OBJECTIVE	Effect parameters were mean arterial blood pressure ( MABP ) , left ventricular output ( LVO ) and global cerebral blood flow ( CBF ) .\
METHODS	In a randomised , clinical control trial 36 preterm neonates were randomised to receive either dopamine 5 microg/kg per min , volume expansion with albumin 20 % 15 ml/kg or no treatment .\
METHODS	Parameters were measured before and 2 h after initiation of treatment .\
RESULTS	Dopamine was effective in increasing MABP ; both treatments increased LVO , whereas no significant difference between the treatment groups and the control group could be demonstrated with regard to CBF .\
CONCLUSIONS	No effect on global cerebral blood flow could be demonstrated in this study , despite significant effects on systemic circulatory parameters .\
CONCLUSIONS	However , the variance on the measurement of cerebral blood flow indicates that a small but clinically significant effect may have been overlooked .\
\
###25649214\
BACKGROUND	Vascular access devices ( VADs ) , such as peripheral or central venous catheters , are vital across all medical and surgical specialties .\
BACKGROUND	To allow therapy or haemodynamic monitoring , VADs frequently require administration sets ( AS ) composed of infusion tubing , fluid containers , pressure-monitoring transducers and/or burettes .\
BACKGROUND	While VADs are replaced only when necessary , AS are routinely replaced every 3-4days in the belief that this reduces infectious complications .\
BACKGROUND	Strong evidence supports AS use up to 4days , but there is less evidence for AS use beyond 4days .\
BACKGROUND	AS replacement twice weekly increases hospital costs and workload .\
METHODS	This is a pragmatic , multicentre , randomised controlled trial ( RCT ) of equivalence design comparing AS replacement at 4 ( control ) versus 7 ( experimental ) days .\
METHODS	Randomisation is stratified by site and device , centrally allocated and concealed until enrolment .\
METHODS	6554 adult/paediatric patients with a central venous catheter , peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4years .\
METHODS	The primary outcome is VAD-related bloodstream infection ( BSI ) and secondary outcomes are VAD colonisation , AS colonisation , all-cause BSI , all-cause mortality , number of AS per patient , VAD time in situ and costs .\
METHODS	Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days ( 95 % CIs ) will summarise the impact of 7-day relative to 4-day AS use and test equivalence .\
METHODS	Kaplan-Meier survival curves ( with log rank Mantel-Cox test ) will compare VAD-BSI over time .\
METHODS	Appropriate parametric or non-parametric techniques will be used to compare secondary end points .\
METHODS	p Values of < 0.05 will be considered significant .\
BACKGROUND	Relevant ethical approvals have been received .\
BACKGROUND	CONSORT Statement recommendations will be used to guide preparation of any publication .\
BACKGROUND	Results will be presented at relevant conferences and sent to the major organisations with clinical practice guidelines for VAD care .\
BACKGROUND	Australian New Zealand Clinical Trial Registry ( ACTRN 12610000505000 ) .\
\
###21820543\
OBJECTIVE	To determine if the use of a plantar flexion device ( Step It pedal ) in a newly developed exercise programme is of benefit to patients with peripheral arterial disease .\
METHODS	Prospective feasibility trial with patients randomised to either standard care or the Step It exercise programme plus standard care .\
METHODS	Physiotherapy Department at Cumberland Infirmary , Carlisle , UK .\
METHODS	Patients were identified from the vascular team 's referral list .\
METHODS	In total , 42 patients agreed to take part ; 18 in the control group and 24 in the intervention group .\
METHODS	Eligible participants were randomised and received either standard care or took part in a plantar flexion resistance exercise programme , involving the Step It pedal , for a period of 12 weeks .\
METHODS	Maximum walking distance , claudication distance and ankle brachial pressure index .\
RESULTS	Eighty-three percent of patients completed the study .\
RESULTS	Improvements in median distance to claudication symptoms and maximum walking distance were observed in the intervention group but not in the control group .\
RESULTS	Nine out of 15 ( 60 % ) participants in the control group and 14 out of 20 ( 70 % ) participants in the intervention group improved their walking distance .\
RESULTS	Ankle brachial pressure index remained virtually unchanged in both groups .\
CONCLUSIONS	Due to the variability of patients ' fitness in the sample , it can not be concluded whether use of the Step It pedal has additional benefits to patients over standard care .\
CONCLUSIONS	However , the study completion rate implies that patients with peripheral arterial disease are receptive to undertaking exercise programmes .\
\
###25143342\
BACKGROUND	In-home iron fortification for infants in developing countries is recommended for control of anaemia , but low absorption typically results in > 80 % of the iron passing into the colon .\
BACKGROUND	Iron is essential for growth and virulence of many pathogenic enterobacteria .\
BACKGROUND	We determined the effect of high and low dose in-home iron fortification on the infant gut microbiome and intestinal inflammation .\
METHODS	We performed two double-blind randomised controlled trials in 6-month-old Kenyan infants ( n = 115 ) consuming home-fortified maize porridge daily for 4 months .\
METHODS	In the first , infants received a micronutrient powder ( MNP ) containing 2.5 mg iron as NaFeEDTA or the MNP without iron .\
METHODS	In the second , they received a different MNP containing 12.5 mg iron as ferrous fumarate or the MNP without the iron .\
METHODS	The primary outcome was gut microbiome composition analysed by 16S pyrosequencing and targeted real-time PCR ( qPCR ) .\
METHODS	Secondary outcomes included faecal calprotectin ( marker of intestinal inflammation ) and incidence of diarrhoea .\
METHODS	We analysed the trials separately and combined .\
RESULTS	At baseline , 63 % of the total microbial 16S rRNA could be assigned to Bifidobacteriaceae but there were high prevalences of pathogens , including Salmonella Clostridium difficile , Clostridium perfringens , and pathogenic Escherichia coli .\
RESULTS	Using pyrosequencing , + FeMNPs increased enterobacteria , particularly Escherichia/Shigella ( p = 0.048 ) , the enterobacteria/bifidobacteria ratio ( p = 0.020 ) , and Clostridium ( p = 0.030 ) .\
RESULTS	Most of these effects were confirmed using qPCR ; for example , + FeMNPs increased pathogenic E. coli strains ( p = 0.029 ) .\
RESULTS	+ FeMNPs also increased faecal calprotectin ( p = 0.002 ) .\
RESULTS	During the trial , 27.3 % of infants in +12.5 mgFeMNP required treatment for diarrhoea versus 8.3 % in -12.5 mgFeMNP ( p = 0.092 ) .\
RESULTS	There were no study-related serious adverse events in either group .\
CONCLUSIONS	In this setting , provision of iron-containing MNPs to weaning infants adversely affects the gut microbiome , increasing pathogen abundance and causing intestinal inflammation .\
BACKGROUND	NCT01111864 .\
\
###19884426\
BACKGROUND	Multimodal pain-control protocols that include periarticular injections have been reported to decrease pain and improve early outcomes following total knee arthroplasty .\
BACKGROUND	While injections containing a corticosteroid have been demonstrated to be safe and effective , we are not aware of any randomized trials in which the specific effect of the corticosteroid on early postoperative outcomes has been evaluated .\
BACKGROUND	The purpose of this double-blind study was to compare the clinical efficacy of periarticular injections consisting of bupivacaine , morphine , epinephrine , clonidine , and cefuroxime as well as a corticosteroid ( methylprednisolone acetate ) with the efficacy of periarticular injections consisting of the same agents but without the inclusion of a corticosteroid .\
METHODS	Seventy-six patients were randomized to either the no-steroid group ( thirty-seven patients ) or the steroid group ( thirty-nine patients ) .\
METHODS	Pain and narcotic consumption during the inpatient stay and the length of the hospital stay were recorded .\
METHODS	Knee Society scores , the range of motion , and the occurrence of any complications were recorded preoperatively and at six and twelve weeks after the surgery .\
RESULTS	The hospital stay was significantly shorter for patients in the steroid group ( 2.6 days compared with 3.5 days in the no-steroid group ; p = 0.01 ) .\
RESULTS	No significant group differences in terms of pain , narcotic consumption , outcome scores , or motion were identified .\
RESULTS	There were three complications in the steroid group : two patients required a manipulation under anesthesia , and the knee joint became infected in another patient , leading to numerous complications and ultimately death .\
CONCLUSIONS	The periarticular injection of a corticosteroid may reduce the length of the hospital stay following total knee arthroplasty , but it does not appear to improve pain relief , motion , or function in the early postoperative period .\
CONCLUSIONS	While we can not definitively state that the corticosteroid was a causative factor in the development of the infection at the site of the prosthetic joint , we can not rule it out either , which raises concern regarding the role of corticosteroids in perioperative pain management following total knee arthroplasty .\
\
###23579179\
OBJECTIVE	The purpose of this study was to determine the efficacy of two Internet-based psycho-educational programs designed to improve outcomes for youth with type 1 diabetes transitioning to adolescence .\
METHODS	The study was a multisite clinical trial of 320 youth ( aged 11-14 years ; 37 % minority ; 55 % female ) randomized to one of two Internet-based interventions : TeenCope or Managing Diabetes .\
METHODS	Primary outcomes were HbA1c and quality of life ( QOL ) .\
METHODS	Secondary outcomes included coping , self-efficacy , social competence , self-management , and family conflict .\
METHODS	Data were collected at baseline and after 3 , 6 , and 12 months online .\
METHODS	Youth were invited to cross over to the other program after 12 months , and follow-up data were collected at 18 months .\
METHODS	Analyses were based on mixed models using intent-to-treat and per-protocol procedures .\
RESULTS	Youth in both groups had stable QOL and minimal increases in HbA1c levels over 12 months , but there were no significant differences between the groups in primary outcomes .\
RESULTS	After 18 months , youth who completed both programs had lower HbA1c ( P = 0.04 ) ; higher QOL ( P = 0.02 ) , social acceptance ( P = 0.01 ) , and self-efficacy ( P = 0.03 ) and lower perceived stress ( P = 0.02 ) and diabetes family conflict ( P = 0.02 ) compared with those who completed only one program .\
CONCLUSIONS	Internet interventions for youth with type 1 diabetes transitioning to adolescence result in improved outcomes , but completion of both programs was better than only one , suggesting that these youth need both diabetes management education and behavioral interventions .\
CONCLUSIONS	Delivering these programs via the Internet represents an efficient way to reach youth and improve outcomes .\
\
###8706483\
OBJECTIVE	To investigate the effects of adjunctive therapy with parenteral N-acetyl-L-cysteine in patients with newly diagnosed septic shock .\
METHODS	Prospective , randomized , double-blind , placebo-controlled study .\
METHODS	Multidisciplinary intensive care unit at a university teaching hospital .\
METHODS	Twenty patients ( N-acetyl-L-cysteine group [ n = 10 ] , placebo group [ n = 10 ] ) , 15 male and five female , of mean age 64 + / - 15 ( SD ) yrs and Acute Physiology and Chronic health Evaluation ( APACHE ) II score 33 + / - 6 , with septic shock within 24 hrs of diagnosis .\
METHODS	After a 2-hr stabilization period ( time-zero minus 2 hrs to time-zero ) , patients received either N-acetyl-L-cysteine in 5 % dextrose ( 150 mg/kg in 100 mL over 15 mins , followed by 50 mg/kg in 250 mL over 4 hrs , and then 100 mg/kg/24 hrs in 500 mL for 44 hrs ; N-acetyl-L-cysteine group ) or the equivalent volume of 5 % dextrose ( placebo group ) .\
RESULTS	Hemodynamic and oxygen transport indices were measured at time-zero minus 2 hrs and time-zero , and at multiple time points thereafter until completion of the trial infusion ( time-zero plus 48 hrs ) .\
RESULTS	A daily Organ Failure Score was recorded for 14 days .\
RESULTS	Treatment group demographics and hemodynamic variables did not differ significantly between the two groups at time-zero .\
RESULTS	Mean ( SD ) , pooled mean arterial pressure ( MAP ) , and cardiac index were 75 + / - 15 mm Hg and 3.9 + / - 1.2 L/min/m2 , respectively .\
RESULTS	Over the next 48 hrs , in the N-acetyl-L-cysteine group , there was a progressive decrease , relative to both time-zero and the placebo group , in MAP , cardiac index , and left ventricular stroke work index ( p < .01 , repeated-measures analysis of variance ) .\
RESULTS	Percentage reductions in these values relative to the placebo group at 48 hrs were 23 % , 18 % , and 43 % , respectively Oxygen transport indices , arterial blood gas analyses , Pao2/Fio2 ratio , and shunt did not differ over time between the groups .\
RESULTS	There was no difference in either daily Organ Failure Score over time ( p > .01 , repeated-measures analysis of variance ) or hospital mortality rate ( 90 % N-acetyl-L-cysteine group , 50 % placebo group ) ( p > .1 , logistic regression ) between the two groups .\
CONCLUSIONS	Adjunctive therapy with N-acetyl-L-cysteine in newly diagnosed septic shock was associated with a depression in cardiovascular performance , as indicated by progressive reductions in cardiac index , left ventricular stroke work index , and MAP .\
\
###11034037\
OBJECTIVE	To determine if clinical pharmacists could affect economic resource use and humanistic outcomes in an ambulatory , high-risk population .\
METHODS	Prospective , randomized , controlled study .\
METHODS	Nine Veterans Affairs medical centers .\
METHODS	Patients who were at high risk for medication-related problems .\
METHODS	Patients were randomized to usual medical care with input from a clinical pharmacist ( intervention group ) or just usual medical care ( control group ) .\
RESULTS	Of 1,054 patients enrolled , 523 were randomized to the intervention group and 531 to the control group .\
RESULTS	The number of clinic visits increased in the intervention group ( p = 0.003 ) , but there was no difference in clinic costs .\
RESULTS	Mean increases in total health care costs were $ 1,020 for the intervention group and $ 1,313 for the control group ( p = 0.06 ) .\
CONCLUSIONS	Including the cost of pharmacist interventions , overall health care expenditures were similar for patients randomized to see a clinical pharmacist versus usual medical care .\
\
###23461482\
OBJECTIVE	To investigate use of educational audiotape programme on anxiety and depression in patients undergoing coronary artery bypass graft ( CABG ) .\
BACKGROUND	Anxiety and depression after CABG are the most common complications , having a negative impact on the prognosis of heart disease , leading to special needs according to their new physical and mental conditions .\
METHODS	Randomised clinical trial .\
METHODS	This study conducted in Iran , 70 patients undergoing CABG were included and divided into two equal groups , the control group and intervention group .\
METHODS	They were followed up for six weeks .\
METHODS	An audiotape educational programme was given to the intervention group after surgery in addition to the routine training .\
METHODS	But patients in the control group received only routine training .\
METHODS	Anxiety and depression were assessed by Hospital Anxiety and Depression Scale , a standardised questionnaire for anxiety and depression .\
METHODS	Data were collected before and six weeks after the intervention .\
METHODS	For the comparison of mean scores between the groups , the data were analysed in spss , version 16 , using independent T-test and paired T-test .\
RESULTS	The mean scores obtained in both anxiety and depression dimensions were significantly different between the intervention and control groups .\
CONCLUSIONS	Audiotape educational programme used by patients undergoing CABG decreases the level of their anxiety and depression after cardiac surgery .\
CONCLUSIONS	The most significant finding was the importance of audiotape educational programme to meet the needs of the CABG patients , which suggest that patient education through audiotape can be effective in self-care after heart surgery and nurses can use an audiotape containing preparatory information to improve outcomes and reduce anxiety and depression in patients having CABG .\
\
###1402726\
BACKGROUND	Despite national priorities in cancer control , the number of people with established ongoing medical care who do not receive indicated preventive services is substantial .\
BACKGROUND	Proven strategies to optimize preventive care in community practice are limited .\
METHODS	In the Cancer Prevention in Community Practice Project ( CPCP ) , 50 primary care providers were randomly assigned to receive an `` office system '' intervention .\
METHODS	The intervention led to reorganization of office operations based on four functional core components : identifying patients ' needs for services ; monitoring their status over time ; providing positive reinforcement to patients ; and establishing an internal feedback component consisting of a brief audit to assess how the system is operating .\
METHODS	Implementation of the CPCP system in each practice was accomplished using trained facilitators , and involved incorporating one or more tools developed to meet the functional components of the practice .\
RESULTS	One hundred percent of the practices were successful in implementing some changes in their office operations that met CPCP office system functional criteria .\
RESULTS	All study practices implemented customized flow sheets , while use of other office system tools were incorporated at between 32 % to 75 % of study sites .\
RESULTS	Identifying patients in need of preventive services was performed most often by the clinical staff ( 39 % ) , whereas monitoring patients ' receipt of preventive services over time and reinforcing positive patient behavior were performed most often by physicians ( 63 % and 46 % , respectively ) .\
RESULTS	Changes made in practices were maintained for at least 12 months .\
CONCLUSIONS	Primary care practices in community settings can implement significant and lasting changes in their practice environment that will improve their performance of preventive activities .\
CONCLUSIONS	The functional components of the CPCP office system design proposed and tested here are applicable to a wide variety of practice settings .\
\
###25525743\
OBJECTIVE	Endothelial function is an independent predictor of prognosis in heart failure ( HF ) subjects .\
OBJECTIVE	Statins , beyond their lipid lowering role , exert beneficial effect in patients with atherosclerosis .\
OBJECTIVE	In the present study we examined the impact of low and intermediate dose atorvastatin treatment on endothelial function , bone marrow-derived endothelial progenitor cells ( EPC ) mobilization and inflammatory status according to HF patient status .\
METHODS	We studied the effect of 4 weeks administration of atorvastatin in 26 patients with ischemic HF .\
METHODS	The study was carried out on two separate arms , one with atorvastatin 40mg/d and one with atorvastatin 10mg/d ( randomized , double-blind , cross-over design ) .\
METHODS	The number of circulating CD34 ( + ) / CD133 ( + ) / KDR ( + ) EPCs was evaluated by flow cytometry .\
METHODS	Endothelial function was evaluated by flow mediated dilation ( FMD ) in the brachial artery .\
METHODS	Serum levels of tumor necrosis factor alpha ( TNF - ) were measured by ELISA .\
RESULTS	Treatment with atorvastatin 40mg/d significantly increased circulating EPC ( p = 0.002 ) , FMD ( p = 0.001 ) and reduced TNF - ( p = 0.01 ) compared to baseline .\
RESULTS	Similarly , treatment with atorvastatin 10mg/day increased circulating EPC ( p = 0.01 ) , FMD ( p = 0.08 ) and reduced TNF - ( p = 0.01 ) compared to baseline .\
RESULTS	Interestingly , with 40mg/day atorvastatin treatment the increase in EPC was higher in subjects categorized as NYHA class II compared to subjects categorized as NYHA class III ( p = 0.03 ) .\
CONCLUSIONS	Our results confirmed the distinct impact of atorvastatin treatment on the restoration of endothelial function due to EPC mobilization in ischemic HF subjects .\
CONCLUSIONS	Moreover , these findings provide the potential clinical significance of EPC status monitoring to individualize treatment in HF subjects .\
\
###23871112\
OBJECTIVE	To quantify changes in endothelial cell counts and corneal thickness measurements in patients having standard phacoemulsification compared with femtosecond laser-assisted cataract removal .\
METHODS	Ruhr University Eye Clinic , Bochum , Germany .\
METHODS	Prospective randomized intraindividual cohort study .\
METHODS	One eye of each patient had standard phacoemulsification ( control group ) and the other eye had femtosecond laser-assisted phacoemulsification ( study group ) , both with intraocular lens implantation .\
METHODS	Pulsed ultrasound energy was used for phacoemulsification .\
METHODS	Noncontact endothelial cell microscopy and corneal pachymetry were performed preoperatively and 1 day , 3 to 4 days , 7 to 10 days , 50 to 60 days , and 90 to 100 days postoperatively .\
RESULTS	The mean endothelial cell loss was 7.9 % 7.8 % ( SD ) 1 week postoperatively and 8.1 % 8.1 % 3 months postoperatively in the study group and 12.1 % 7.3 % and 13.7 % 8.4 % , respectively , in the control group .\
RESULTS	The mean relative change in corneal thickness from the preoperative values was -0.0 % 1.9 % at 1 day , 2.8 % 1.8 % at 1 week , and 3.3 % 1.7 % at 3 months in the study group and -0.9 % 2.3 % , 2.4 % 1.5 % , and 3.2 % 1.4 % , respectively , in the control group .\
CONCLUSIONS	The femtosecond laser did not add to the endothelial damage caused by cataract surgery and might be beneficial in eyes with low preoperative endothelial cell values ( eg , cornea guttata cases ) .\
\
###11830814\
OBJECTIVE	To determine the clinical effect of electrocautery with arthroscopic chondroplasty on chondromalacic tissue .\
METHODS	A randomized , prospective study .\
METHODS	In a prospective study , 146 patients were randomly placed in either a control group ( chondroplasty alone ) or a treatment group ( chondroplasty and electrocautery ) .\
METHODS	Intraoperative findings in both treatment and control groups were classified by both the extent of chondromalacia and the number of compartments in which chondromalacia was diagnosed .\
METHODS	In our study , we used 6 defined compartments : medial and lateral tibial plateau , medial and lateral femoral condyles , patella , and femoral trochlea .\
METHODS	Patients were followed up at 1 year and evaluated using the Lysholm scale .\
METHODS	Postoperative Lysholm scores were matched against compartment involvement and compared between groups .\
RESULTS	There was no significant difference in the patients with grade 2 chondromalacia in either control or cautery group ( P > .5 ) .\
RESULTS	Groups with grade 3 chondromalacia showed a significant difference favoring the control group ( P < .05 ) .\
RESULTS	A significant difference was found in comparing 2-compartment chondromalacia between the 2 treatment cohorts , again , favoring the control group ( P = .01 ) .\
RESULTS	The remaining groups of multiple compartment chondromalacia showed no significant difference , indicating that the postoperative result was independent of the use of electrocautery .\
CONCLUSIONS	This study shows that electrocautery as an adjunct to chondroplasty offers little benefit in the treatment of chondromalacic lesions and may , in fact , limit successful outcome .\
\
###14666758\
OBJECTIVE	To observe the therapeutic effect of Shenmai Injection ( SI ) in treating congestive heart failure ( CHF ) .\
METHODS	The changes in cAMP , cGMP , serum cardiac troponin T ( cTnT , a specific marker reflecting myocardial injury ) , creatine kinase ( CK ) and creatine kinase isoenzyme ( CK-MB ) were simultaneously monitored in 62 chronic CHF patients , distributed in the two groups , the routine treatment group and the routine treatment + SI group , by randomized grouping method , and the therapeutic effect of the two groups was compared .\
RESULTS	The plasma cAMP/cGMP ratio increased in early stage and decreased in late stage of the course of CHF .\
RESULTS	The serum cTnT level was progressively increased along with heart function deterioration .\
RESULTS	After treated with SI for 2 weeks , the CHF patients ' hemodynamics got stable and heart function obviously improved .\
RESULTS	No serious adverse reaction was found in the therapeutic course .\
CONCLUSIONS	The level of serum cTnT might be taken as a reliable biochemical parameter to predict the prognosis of CHF patients .\
CONCLUSIONS	SI is an effective and safe agent in treating CHF .\
\
###20429895\
BACKGROUND	Tobacco smoking remains the leading preventable cause of death among American women .\
BACKGROUND	Exercise has shown promise as an aid to smoking cessation because it reduces weight gain and weight concerns , improves affect , and reduces nicotine withdrawal symptoms and cigarette craving .\
BACKGROUND	Studies have shown that the practice of yoga improves weight control , and reduces perceived stress and negative affect .\
BACKGROUND	Yoga practice also includes regulation of breathing and focused attention , both of which may enhance stress reduction and improve mood and well-being and may improve cessation outcomes .\
METHODS	This pilot efficacy study is designed to examine the rates of cessation among women randomized to either a novel , 8-week Yoga plus Cognitive Behavioral Therapy ( CBT ) smoking cessation intervention versus a Wellness program plus the same CBT smoking cessation intervention .\
METHODS	Outcome measures include 7-day point prevalence abstinence at end of treatment , 3 and 6 months follow up and potential mediating variables ( e.g. , confidence in quitting smoking , self-efficacy ) .\
METHODS	Other assessments include measures of mindfulness , spirituality , depressive symptoms , anxiety and perceived health ( SF-36 ) .\
CONCLUSIONS	Innovative treatments are needed that address barriers to successful smoking cessation among men and women .\
CONCLUSIONS	The design chosen for this study will allow us to explore potential mediators of intervention efficacy so that we may better understand the mechanism ( s ) by which yoga may act as an effective complementary treatment for smoking cessation .\
CONCLUSIONS	If shown to be effective , yoga can offer an alternative to traditional exercise for reducing negative symptoms that often accompany smoking cessation and predict relapse to smoking among recent quitters .\
BACKGROUND	ClinicalTrials NCT00492310 .\
\
###23359581\
BACKGROUND	The primary aim of this randomized study was to describe the feasibility of early administration of surfactant via a thin catheter during spontaneous breathing ( Take Care ) and compare early mechanical ventilation ( MV ) requirement with the InSurE ( Intubate , Surfactant , Extubate ) procedure .\
METHODS	Preterm infants , who were < 32 weeks and stabilized with nasal continuous positive airway pressure ( nCPAP ) in the delivery room , were randomized to receive early surfactant treatment either by the Take Care or InSurE technique .\
METHODS	Tracheal instillation of 100 mg/kg poractant via 5-F catheter during spontaneous breathing under nCPAP was performed in the intervention group .\
METHODS	In the InSurE procedure , infants were intubated , received positive pressure ventilation for 30 seconds after surfactant instillation , and placed on nCPAP immediately .\
RESULTS	One hundred infants in each group were analyzed .\
RESULTS	The MV requirement in the first 72 hours of life was significantly lower in the Take Care group when compared with the InSurE group ( 30 % vs 45 % , P = .02 , odds ratio -0.52 , 95 % confidence interval -0.94 to -0.29 ) .\
RESULTS	Mean duration of both nCPAP and MV were significantly shorter in the Take Care group ( P values .006 and .002 , respectively ) .\
RESULTS	Bronchopulmonary dysplasia rate was significantly lower among the infants treated with the Take Care technique ( relative risk -0.27 , 95 % confidence interval -0.1 to -0.72 )\
CONCLUSIONS	The Take Care technique is feasible for the treatment of respiratory distress syndrome in infants with very low birth weight .\
CONCLUSIONS	It significantly reduces both the need and duration of MV , and thus the bronchopulmonary dysplasia rate in preterm infants .\
\
###18266665\
OBJECTIVE	To test the hypothesis that methylphenidate modifies markers of fall risk in older adults .\
METHODS	Randomized , double-blind , placebo-controlled , single-dose cross-over study .\
METHODS	Outpatient movement disorders clinic .\
METHODS	Twenty-six community-living older adults without dementia ( mean age 73.8 ) with subjective complaints of `` memory problems . ''\
METHODS	The study examined the effects of a single dose of 20 mg of methylphenidate ( MPH ) on cognitive function and gait .\
METHODS	Participants were evaluated before and 2 hours after taking MPH or a placebo in sessions 1 to 2 weeks apart .\
METHODS	The Timed Up and Go and gait variability quantified mobility and fall risk .\
METHODS	A computerized neuropsychology battery quantified memory and executive function ( EF ) .\
RESULTS	Timed Up and Go times , stride time variability , and measures of EF significantly improved in response to MPH but not in response to the placebo .\
RESULTS	In contrast , MPH did not significantly affect memory or finger tapping abilities .\
CONCLUSIONS	In older adults , MPH appears to improve certain aspects of EF , mobility , and gait stability .\
CONCLUSIONS	Although additional studies are required to assess clinical utility and efficacy , the present findings suggest that methylphenidate and other drugs that are designed to enhance attention may have a role as a therapeutic option for reducing fall risk in older adults .\
\
###20684440\
OBJECTIVE	Placing a Class II restoration in a tooth changes the local environment , including that for the adjacent tooth .\
OBJECTIVE	Apart from the change to a less - or non-cariogenic environment for the restored tooth , the effect of leachable components from a restoration in the adjacent tooth should be taken into consideration .\
METHODS	Practice-based clinical studies comprising of 1341 unrestored proximal surfaces in contact with Class II restorations using different restorative materials were reviewed to assess the effect on the caries development on the adjacent teeth .\
METHODS	The caries status of the adjacent un-restored proximal surface was assessed as being clinically sound , having active caries with or without cavitation , or having arrested caries .\
METHODS	Restorations from nine clinicians were reviewed .\
METHODS	They had attended annual meetings where all aspects of the investigation had been discussed .\
METHODS	The surfaces were followed for up to eight years .\
RESULTS	A reduced rate of caries development and progression were found on surfaces in contact with fluoride releasing materials like glass ionomers , resin modified glass ionomers and compomers compared to surfaces in contact with amalgam .\
CONCLUSIONS	Fluoride releasing materials reduce the development and progression of primary caries on adjacent proximal surfaces .\
\
###17275141\
OBJECTIVE	Effects of combined nutritional treatment of patients at risk of protein-energy malnutrition ( PEM ) discharged from a geriatric service were evaluated .\
METHODS	Patients ( n = 108 , age 85 + / -6 years ) at risk of malnutrition according to the short form of the mini nutritional assessment were randomly allocated to dietary counseling , including liquid and multivitamin supplementation , i.e. intervention ( I , n = 51 ) and to controls ( C , n = 57 ) .\
METHODS	Body weight , biochemical indices ( e.g. insulin-like growth factor I ( IGF-I ) ) , Katz activities of daily living ( ADL ) index , mini mental status examination ( MMSE ) and quality of life ( QoL ) by SF-36 were assessed at the start of the study and after 4 months .\
METHODS	Statistical analyses were performed on `` intention-to-treat '' and on `` treated-as-protocol '' bases .\
RESULTS	Fifty-four patients , 29 in the I-group ( 86 + / -7 years , 66 % females ) and 25 in the C-group ( 85 + / -7 years , 72 % females ) completed the study according to the protocol .\
RESULTS	Both modes of analysis revealed a significant positive effect of the combined nutritional intervention on weight maintenance .\
RESULTS	Treated-as-protocol analyses showed that Katz ADL index improved in the I-group ( p < 0.001 ; p < 0.05 between the groups ) .\
RESULTS	Serum IGF-I levels increased in the I-group ( p < 0.001 ) , but were unchanged in the C-group ( p = 0.07 between the groups ) .\
RESULTS	QoL was assessed to be low and had not changed after nutritional treatment .\
CONCLUSIONS	Combined nutritional intervention prevented weight loss and improved ADL functions in discharged geriatric patients at risk of malnutrition .\
\
###15993724\
BACKGROUND	In animals in cardiac arrest , an inspiratory impedance threshold device ( ITD ) has been shown to improve hemodynamics and neurologically intact survival .\
BACKGROUND	The objective of this study was to determine whether an ITD would improve blood pressure ( BP ) in patients receiving CPR for out-of-hospital cardiac arrest .\
METHODS	This prospective , randomized , double-blind , intention-to-treat study was conducted in the Milwaukee , WI , emergency medical services ( EMS ) system .\
METHODS	EMS personnel used an active ( functional ) or sham ( non-functional ) ITD on a tracheal tube on adults in cardiac arrest of presumed cardiac etiology .\
METHODS	Care between groups was similar except for ITD type .\
METHODS	Low dose epinephrine ( 1mg ) was used per American Heart Association Guidelines .\
METHODS	Femoral arterial BP ( mmHg ) was measured invasively during CPR .\
RESULTS	Mean + / - S.D. time from ITD placement to first invasive BP recording was approximately 14 min .\
RESULTS	Twelve patients were treated with a sham ITD versus 10 patients with an active ITD .\
RESULTS	Systolic BPs ( mean + / - S.D. ) [ number of patients treated at given time point ] at T = 0 ( time of first arterial BP measurement ) , and T = 2 , 5 and 7 min were 85 + / -29 [ 10 ] , 85 + / -23 [ 10 ] , 85 + / -16 [ 9 ] and 69 + / -22 [ 8 ] in the group receiving an active ITD compared with 43 + / -15 [ 12 ] , 47 + / -16 [ 12 ] , 47 + / -20 [ 9 ] , and 52 + / -23 [ 9 ] in subjects treated with a sham ITD , respectively ( p < 0.01 for all times ) .\
RESULTS	Diastolic BPs at T = 0 , 2 , 5 and 7 min were 20 + / -12 , 21 + / -13 , 23 + / -15 and 25 + / -14 in the group receiving an active ITD compared with 15 + / -9 , 17 + / -8 , 17 + / -9 and 19 + / -8 in subjects treated with a sham ITD , respectively ( p = NS for all times ) .\
RESULTS	No significant adverse device events were reported .\
CONCLUSIONS	Use of the active ITD was found to increase systolic pressures safely and significantly in patients in cardiac arrest compared with sham controls .\
\
###17986319\
BACKGROUND	We present the design of an open randomized multi-centre study on surgical versus conservative treatment of acute Achilles tendon ruptures .\
BACKGROUND	The study is designed to evaluate the effectiveness of conservative treatment in reducing complications when treating acute Achilles tendon rupture .\
METHODS	At least 72 patients with acute Achilles tendon rupture will be randomized to minimally invasive surgical repair followed by functional rehabilitation using tape bandage or conservative treatment followed by functional rehabilitation with use of a functional bracing system .\
METHODS	Both treatment arms use a 7 weeks post-rupture rehabilitation protocol .\
METHODS	Four hospitals in the Netherlands will participate .\
METHODS	Primary end-point will be reduction in complications other than re-rupture .\
METHODS	Secondary end-point will be re-rupturing , time off work , sporting activity post rupture , functional outcome by Leppilahti score and patient satisfaction .\
METHODS	Patient follow-up will be 12 month .\
CONCLUSIONS	By making this design study we wish to contribute to more profound research on AT rupture treatment and prevent publication bias for this open-labelled randomized trial .\
BACKGROUND	ISRCTN50141196 .\
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###22378736\
BACKGROUND	Mechanistic data suggest that n-3 PUFAs and endothelial function may interact and play a role in carcinogenesis , but epidemiologic evidence is lacking .\
OBJECTIVE	Our objective was to investigate whether the prospective association between soluble intercellular adhesion molecule-1 ( sICAM-1 ) and cancer risk is modulated by n-3 PUFA intake .\
METHODS	A nested case-control study was designed to include all first-incident cancer cases diagnosed in the SUpplmentation en VItamines et Minraux AntioXydants cohort between 1994 and 2007 , with available dietary data from 24-h records ( n = 408 ) .\
METHODS	Cases were matched with 1 or 2 randomly selected controls ( n = 760 ) .\
METHODS	Conditional logistic regression was used to estimate ORs and 95 % CIs for the association between prediagnostic plasma concentrations of sICAM-1 and cancer risk , stratified by n-3 PUFA intake .\
METHODS	The interactions between sICAM-1 and n-3 PUFA intake were tested .\
RESULTS	An interaction was observed between sICAM-1 and n-3 PUFA intake , which was consistent across the studied cancer locations ( P-interaction = 0.036 for overall , 0.038 for breast , and 0.020 for prostate cancer risk ) .\
RESULTS	sICAM-1 concentrations were positively associated with cancer risk among subjects with n-3 PUFA intakes below the median ( multivariate OR ( Tertile3vsTertile1 ) : 2.8 ; 95 % CI : 1.5 , 5.2 ; P-trend = 0.001 ) , whereas this association was not observed for subjects with n-3 PUFA intakes above the median ( OR ( Tertile3vsTertile1 ) : 1.3 ; 95 % CI : 0.8 , 2.3 ; P-trend = 0.3 ) .\
CONCLUSIONS	These findings suggest that n-3 PUFA intake may counteract the procarcinogenic actions of sICAM-1 .\
\
###16537263\
OBJECTIVE	To evaluate the effectiveness of a computerized , errorless learning-based memory rehabilitation program for Chinese patients with traumatic brain injury ( TBI ) .\
METHODS	This study adopted a pre - and post-test quasi-experimental design .\
METHODS	A total of 37 patients with TBI were randomly assigned to a Computer-Assisted Memory Training Group ( CAMG ) , a Therapist-administered Memory Training Group ( TAMG ) and a Control Group ( CG ) .\
METHODS	Except for the CG , the patients in both the CAMG and TAMG groups received , respectively , 1-month memory training programmes that were similar in content but differed in delivery mode .\
METHODS	All patients were followed up 1 month after treatment .\
METHODS	The outcome measures that were taken were the Neurobehavioural Cognitive Status Examination ( NCSE or Cognistat ) , the Rivermead Behavioural Memory Test ( RBMT ) and The Hong Kong List Learning Test ( HKLLT ) .\
METHODS	Repeated measure analyses were performed to investigate differences among the three groups .\
RESULTS	The patients in the Computer-assisted Memory Rehabilitation ( CAMG ) and Therapist-administered Memory Rehabilitation group ( TAMG ) were found to perform better than the CG in the NCSE and RBMT , but no significant differences were found between the CAMG and TAMG .\
RESULTS	The CAMG showed significant improvement in their HKLLT assessment as compared with the TAMG and CG .\
RESULTS	No statistically significant differences were found between the CAMG and TAMG when comparing the post-training outcome measures with the follow-up results .\
CONCLUSIONS	There is no difference between CAMG and TAMG , but the efficacy has been demonstrated when comparing with CG .\
CONCLUSIONS	It is suggested that the combined use of an errorless learning and a computerized approach may be an effective way of enhancing the memories of patients with TBI .\
CONCLUSIONS	This new method may smooth the progress of the whole human memory process and produce a better carryover treatment effect .\
\
###14679153\
BACKGROUND	Although chemotherapy and ovarian function suppression are both effective adjuvant therapies for patients with early-stage breast cancer , little is known of the efficacy of their sequential combination .\
BACKGROUND	In an International Breast Cancer Study Group ( IBCSG ) randomized clinical trial ( Trial VIII ) for pre - and perimenopausal women with lymph node-negative breast cancer , we compared sequential chemotherapy followed by the gonadotropin-releasing hormone agonist goserelin with each modality alone .\
METHODS	From March 1990 through October 1999 , 1063 patients stratified by estrogen receptor ( ER ) status and radiotherapy plan were randomly assigned to receive goserelin for 24 months ( n = 346 ) , six courses of `` classical '' CMF ( cyclophosphamide , methotrexate , 5-fluorouracil ) chemotherapy ( n = 360 ) , or six courses of classical CMF followed by 18 months of goserelin ( CMF -- > goserelin ; n = 357 ) .\
METHODS	A fourth arm ( no adjuvant treatment ) with 46 patients was discontinued in 1992 .\
METHODS	Tumors were classified as ER-negative ( 30 % ) , ER-positive ( 68 % ) , or ER status unknown ( 3 % ) .\
METHODS	Twenty percent of patients were aged 39 years or younger .\
METHODS	The median follow-up was 7 years .\
METHODS	The primary outcome was disease-free survival ( DFS ) .\
RESULTS	Patients with ER-negative tumors achieved better disease-free survival if they received CMF ( 5-year DFS for CMF = 84 % , 95 % confidence interval [ CI ] = 77 % to 91 % ; 5-year DFS for CMF -- > goserelin = 88 % , 95 % CI = 82 % to 94 % ) than if they received goserelin alone ( 5-year DFS = 73 % , 95 % CI = 64 % to 81 % ) .\
RESULTS	By contrast , for patients with ER-positive disease , chemotherapy alone and goserelin alone provided similar outcomes ( 5-year DFS for both treatment groups = 81 % , 95 % CI = 76 % to 87 % ) , whereas sequential therapy ( 5-year DFS = 86 % , 95 % CI = 82 % to 91 % ) provided a statistically nonsignificant improvement compared with either modality alone , primarily because of the results among younger women .\
CONCLUSIONS	Premenopausal women with ER-negative ( i.e. , endocrine nonresponsive ) , lymph node-negative breast cancer should receive adjuvant chemotherapy .\
CONCLUSIONS	For patients with ER-positive ( i.e. , endocrine responsive ) disease , the combination of chemotherapy with ovarian function suppression or other endocrine agents , and the use of endocrine therapy alone should be studied .\
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###23154126\
BACKGROUND	Intravenous immunoglobulin ( IVIG ) and plasmapheresis ( plasma exchange ( PLEX ) ) have comparable efficacy in reducing the Quantitative Myasthenia Gravis Score for disease severity ( QMGS ) in patients with moderate to severe myasthenia gravis ( MG ) .\
OBJECTIVE	To determine if the improvement in the quality of life ( QOL ) after immunomodulation is comparable with either IVIG or PLEX .\
METHODS	62 patients participated in the MG-QOL-60 study , completing the questionnaire at baseline and at day 14 after treatment .\
METHODS	The MG-QOL-15 scores were computed from the MG-QOL-60 questionnaire responses .\
METHODS	We analysed the change in the QOL scores from baseline to day 14 in both treatment groups .\
RESULTS	The scores in both QOL scales decreased at day 14 in the IVIG and PLEX groups , without significant difference between groups ( QOL-15 : IVIG -5.7 8.5 , PLEX : -7.0 7.6 , p = 0.52 ; QOL-60 : IVIG -13.3 16.9 , PLEX -18.5 22.0 , p = 0.41 ) .\
RESULTS	The improvement in QOL showed a good correlation with the decrease in QMGS .\
RESULTS	There was an excellent correlation between the MG-QOL-15 and MG-QOL-60 scores at baseline and at day 14 .\
CONCLUSIONS	This study of MG-QOL changes supports recent findings that IVIG and PLEX are comparable in the treatment of patients with moderate to severe MG and worsening symptoms .\
CONCLUSIONS	Furthermore , our study supports the use of the MG-QOL-15 as a secondary outcome measure in future clinical trials in MG .\
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###11846194\
BACKGROUND	Several antibacterial agents have been studied as a means to produce bactericidal or bacteriostatic activity as an adjunct to mechanical treatment of periodontal disease .\
BACKGROUND	The primary purpose of this study was to evaluate the efficacy of tetracycline strips administered singly or in multiples in conjunction with root planing , versus root planing alone , or to an untreated control .\
BACKGROUND	Secondary purposes were to compare gingival crevicular fluid ( GCF ) volume and GCF concentrations of tetracycline in pockets treated with strips ; to evaluate strip insertion time ; and to compare ease of placement for single or multiple strips .\
METHODS	Using a 4-quadrant design , 4 test teeth in 24 patients were treated with either root planing and single strip application ; root planing and multiple strip application ; root planing alone ; or an untreated control .\
RESULTS	Single and multiple strip placement resulted in a significant reduction in probing depth ( P = 0.033 ) compared to root planing and untreated groups .\
RESULTS	The multiple strip group significantly decreased bleeding on probing ( P = 0.05 ) compared to all other treatment groups .\
RESULTS	There was no treatment effect on GCF ; however , there was a significant reduction in the GCF volume over time ( P = 0.001 ) .\
RESULTS	The time required for placement was , on average , 1.9 minutes for single strips and 3.25 minutes for multiple strips .\
CONCLUSIONS	Our data suggest that multiple strips are superior to a single strip in reducing bleeding on probing , and that local delivery of tetracycline is superior to root planing alone in reducing probing depth .\
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###24046466\
BACKGROUND	Airway suctioning in mechanically ventilated patients is required to maintain airway patency .\
BACKGROUND	Closed suction catheters ( CSCs ) minimize lung volume loss during suctioning but require cleaning post-suction .\
BACKGROUND	Despite their widespread use , there is no published evidence examining lung volumes during CSC cleaning .\
BACKGROUND	The study objectives were to quantify lung volume changes during CSC cleaning and to determine whether these changes were preventable using a CSC with a valve in situ between the airway and catheter cleaning chamber .\
METHODS	This prospective randomized crossover study was conducted in a metropolitan tertiary ICU .\
METHODS	Ten patients mechanically ventilated via volume-controlled synchronized intermittent mandatory ventilation ( SIMV-VC ) and requiring manual hyperinflation ( MHI ) were included in this study .\
METHODS	CSC cleaning was performed using 2 different brands of CSC ( one with a valve [ Ballard Trach Care 72 , Kimberly-Clark , Roswell , Georgia ] and one without [ Portex Steri-Cath DL , Smiths Medical , Dublin , Ohio ] ) .\
METHODS	The maneuvers were performed during both SIMV-VC and MHI .\
METHODS	Lung volume change was measured via impedance change using electrical impedance tomography .\
METHODS	A mixed model was used to compare the estimated means .\
RESULTS	During cleaning of the valveless CSC , significant decreases in lung impedance occurred during MHI ( -2563 impedance units , 95 % CI 2213-2913 , P < .001 ) , and significant increases in lung impedance occurred during SIMV ( 762 impedance units , 95 % CI 452-1072 , P < .001 ) .\
RESULTS	In contrast , cleaning of the CSC with a valve in situ resulted in non-significant lung volume changes and maintenance of normal ventilation during MHI and SIMV-VC , respectively ( 188 impedance units , 95 % CI -136 to 511 , P = .22 ; and 22 impedance units , 95 % CI -342 to 299 , P = .89 ) .\
CONCLUSIONS	When there is no valve between the airway and suction catheter , cleaning of the CSC results in significant derangements in lung volume .\
CONCLUSIONS	Therefore , the presence of such a valve should be considered essential in preserving lung volumes and uninterrupted ventilation in mechanically ventilated patients .\
\
###9050705\
OBJECTIVE	To evaluate the efficacy and safety of topical anesthesia in reducing pain and the frequency of vasovagal reactions during diagnostic hysteroscopy with endometrial biopsy in postmenopausal women .\
METHODS	Randomized , placebo-controlled , double-blind study .\
METHODS	A university hospital .\
METHODS	Forty-two postmenopausal women undergoing diagnostic hysteroscopy and endometrial biopsy .\
METHODS	Two milliliters of 2 % mepivacaine or saline solution was injected transcervically into the uterine cavity before performing the procedures .\
RESULTS	Pain was evaluated on a visual analog scale , and heart rate and blood pressure were monitored continuously .\
RESULTS	Anesthesia reduced the pain experienced at hysteroscopy and endometrial biopsy , but not significantly .\
RESULTS	The frequency of vasovagal reactions was significantly lower in the anesthetized group .\
CONCLUSIONS	Topical anesthesia effectively prevents the occurrence of vasovagal reactions in postmenopausal women undergoing hysteroscopy and endometrial biopsy .\
\
###19161045\
OBJECTIVE	In a previous study , the special extract ERr 731 of Rheum rhaponticum significantly reduced vasomotor and other menopausal symptoms associated with perimenopause .\
OBJECTIVE	This trial was conducted to confirm the efficacy of ERr 731 .\
METHODS	A multicenter , randomized , placebo-controlled , clinical trial with 112 perimenopausal women with menopausal symptoms receiving either 1 enteric-coated tablet of ERr 731 ( n = 56 ) or placebo ( n = 56 ) daily for 12 weeks .\
METHODS	Primary outcome criterion for efficacy of ERr 731 compared to placebo was the change of the Menopause Rating Scale ( MRS ) total score from day 0 to day 84 .\
METHODS	Other efficacy assessments analyzed included the number and severity of hot flushes , individual symptoms of the MRS , treatment outcome , and various safety parameters .\
RESULTS	By 12 weeks , ERr 731 caused a highly significant reduction of the MRS total score from 27.0 + / - 4.7 points to 12.4 + / - 5.3 points when compared to the placebo-induced decrease from 27.0 + / - 5.3 points to 24.0 + / - 6.2 points ( P < .0001 ) .\
RESULTS	A significant reduction in each individual MRS item score , in hot flushes and the hot flush weekly weighted score , together with a marked improvement in treatment outcome were also observed ( P < .0001 ) .\
RESULTS	These results confirm the efficacy of ERr 731 in alleviating menopausal symptoms in perimenopausal women .\
RESULTS	Fourteen adverse events were reported in total : 11 by 5 women receiving ERr 731 and 3 by 3 women receiving placebo .\
RESULTS	ERr 731 was well tolerated by the majority of the women .\
CONCLUSIONS	ERr 731 was confirmed to be effective for the treatment of menopausal symptoms in perimenopause .\
\
###19458303\
OBJECTIVE	The primary objective of this study is to determine whether daily exit-site application of standardized antibacterial honey ( Medihoney Antibacterial Wound Gel ; Comvita , Te Puke , New Zealand ) results in a reduced risk of catheter-associated infections in peritoneal dialysis ( PD ) patients compared with standard topical mupirocin prophylaxis of nasal staphylococcal carriers .\
METHODS	Multicenter , prospective , open label , randomized controlled trial .\
METHODS	PD units throughout Australia and New Zealand .\
METHODS	The study will include both incident and prevalent PD patients ( adults and children ) for whom informed consent can be provided .\
METHODS	Patients will be excluded if they have had ( 1 ) a history of psychological illness or condition that interferes with their ability to understand or comply with the requirements of the study ; ( 2 ) recent ( within 1 month ) exit-site infection , peritonitis , or tunnel infection ; ( 3 ) known hypersensitivity to , or intolerance of , honey or mupirocin ; ( 4 ) current or recent ( within 4 weeks ) treatment with an antibiotic administered by any route ; or ( 5 ) nasal carriage of mupirocin-resistant Staphylococcus aureus .\
METHODS	370 subjects will be randomized 1:1 to receive either daily topical exit-site application of Medihoney Antibacterial Wound Gel ( all patients ) or nasal application of mupirocin if staphylococcal nasal carriage is demonstrated .\
METHODS	All patients in the control and intervention groups will perform their usual exit-site care according to local practice .\
METHODS	The study will continue until 12 months after the last patient is recruited ( anticipated recruitment time is 24 months ) .\
METHODS	The primary outcome measure will be time to first episode of exit-site infection , tunnel infection , or peritonitis , whichever comes first .\
METHODS	Secondary outcome measures will include time to first exit-site infection , time to first tunnel infection , time to first peritonitis , time to infection-associated catheter removal , catheter-associated infection rates , causative organisms , incidence of mupirocin-resistant microbial isolates , and other adverse reactions .\
CONCLUSIONS	This multicenter Australian and New Zealand study has been designed to provide evidence to help nephrologists and their PD patients determine the optimal strategy for preventing PD catheter-associated infections .\
CONCLUSIONS	Demonstration of a significant improvement in PD catheter-associated infections with topical Medihoney will provide clinicians with an important new prophylactic strategy with a low propensity for promoting antimicrobial resistance .\
\
###20924011\
BACKGROUND	Hypertonic fluids restore cerebral perfusion with reduced cerebral edema and modulate inflammatory response to reduce subsequent neuronal injury and thus have potential benefit in resuscitation of patients with traumatic brain injury ( TBI ) .\
OBJECTIVE	To determine whether out-of-hospital administration of hypertonic fluids improves neurologic outcome following severe TBI .\
METHODS	Multicenter , double-blind , randomized , placebo-controlled clinical trial involving 114 North American emergency medical services agencies within the Resuscitation Outcomes Consortium , conducted between May 2006 and May 2009 among patients 15 years or older with blunt trauma and a prehospital Glasgow Coma Scale score of 8 or less who did not meet criteria for hypovolemic shock .\
METHODS	Planned enrollment was 2122 patients .\
METHODS	A single 250-mL bolus of 7.5 % saline/6 % dextran 70 ( hypertonic saline/dextran ) , 7.5 % saline ( hypertonic saline ) , or 0.9 % saline ( normal saline ) initiated in the out-of-hospital setting .\
METHODS	Six-month neurologic outcome based on the Extended Glasgow Outcome Scale ( GOSE ) ( dichotomized as > 4 or 4 ) .\
RESULTS	The study was terminated by the data and safety monitoring board after randomization of 1331 patients , having met prespecified futility criteria .\
RESULTS	Among the 1282 patients enrolled , 6-month outcomes data were available for 1087 ( 85 % ) .\
RESULTS	Baseline characteristics of the groups were equivalent .\
RESULTS	There was no difference in 6-month neurologic outcome among groups with regard to proportions of patients with severe TBI ( GOSE 4 ) ( hypertonic saline/dextran vs normal saline : 53.7 % vs 51.5 % ; difference , 2.2 % [ 95 % CI , -4.5 % to 9.0 % ] ; hypertonic saline vs normal saline : 54.3 % vs 51.5 % ; difference , 2.9 % [ 95 % CI , -4.0 % to 9.7 % ] ; P = .67 ) .\
RESULTS	There were no statistically significant differences in distribution of GOSE category or Disability Rating Score by treatment group .\
RESULTS	Survival at 28 days was 74.3 % with hypertonic saline/dextran , 75.7 % with hypertonic saline , and 75.1 % with normal saline ( P = .88 ) .\
CONCLUSIONS	Among patients with severe TBI not in hypovolemic shock , initial resuscitation with either hypertonic saline or hypertonic saline/dextran , compared with normal saline , did not result in superior 6-month neurologic outcome or survival .\
BACKGROUND	clinicaltrials.gov Identifier : NCT00316004 .\
\
###24267796\
BACKGROUND	Generalised recalcitrant facial verruca plana responds poorly to current therapeutic options , including cryotherapy , topical drugs and carbon dioxide ( CO2 ) laser .\
BACKGROUND	Case reports and uncontrolled studies suggested that topical photodynamic therapy ( PDT ) is effective choice of treatment free from potential complications associated with invasive therapies .\
OBJECTIVE	To investigate the efficacy and safety of PDT with different concentrations of photosensitiser in the treatment of verruca plana .\
METHODS	The two sides of a subject 's face were separately randomized to receive aminolevulinic acid ( ALA ) of 5 % , 10 % or 20 % concentration .\
METHODS	All patients were irradiated with 633-nm red light for 339 J/cm ( 2 ) total dose .\
METHODS	Complete response ( CR ) rate was assessed on Week 4 , 8 , and 16 respectively .\
RESULTS	The mean overall clearance rate was 74.1 % , 68.8 % , and 64.6 % on Week 4 , 8 , and 12 , respectively , in the 110 treated sides .\
RESULTS	The CR rate was lower in the 5 % - ALA group than in the 10 % - ALA group ( 14.3 % vs. 33.3 % , p < 0.05 ) and 20 % - ALA group ( 14.3 % vs. 26.3 % , p < 0.05 ) after 12 weeks .\
RESULTS	The mean severity of pain measured by visual analogue scale ( VAS ) scoring was 3.8 ( range : 2 to 10 , depending on the lesion location ) .\
RESULTS	The overall recurrence rate was 16.7 % ( 4/24 ) on Week 12 .\
RESULTS	Hyperpigmentation was observed in 61 % ( 67/110 ) of all treated sides .\
RESULTS	On Week 4 , 8 , and 16 , hyperpigmentation was more developed in the 20 % - ALA group than in the other two groups ( p < 0.05 ) .\
CONCLUSIONS	In terms of complete clearance rate , the 5 % ALA-PDT group was significantly inferior to the 10 % and 20 % ALA-PDT groups at each follow-up .\
CONCLUSIONS	In contrast , the 20 % ALA group showed a higher incidence rate of transient hyperpigmentation than the other two groups .\
CONCLUSIONS	This randomised clinical trial suggests that PDT with ALA of 10 % concentration offers better efficacy and safety than 5 % or 20 % concentration for generalised recalcitrant facial verruca plana .\
\
###20196678\
OBJECTIVE	This study examined the use of a Video Doctor plus provider cueing to promote provider advice and smoking cessation outcomes in pregnancy .\
METHODS	A randomized clinical trial was conducted from 2006 to 2008 .\
METHODS	Five community prenatal clinics in the San Francisco Bay Area of the United States .\
METHODS	A total of 410 pregnant patients completed screening for behavioral risks including tobacco use in the past 30 days .\
METHODS	Pregnant smokers ( n = 42 ) were randomized regardless of their intention to quit smoking .\
METHODS	Participants were assigned to either usual care or intervention .\
METHODS	Intervention participants received 15-minute Video Doctor sessions plus provider cueing , at baseline and one month , prior to their routine prenatal visit .\
METHODS	The Video Doctor delivered interactive tailored messages , an educational worksheet for participants , and a cueing sheet for providers .\
METHODS	Receipt of advice from the provider and 30-day smoking abstinence , both by self-report .\
RESULTS	Intervention participants were more likely to receive provider advice on tobacco use at both prenatal visits during the intervention period ( 60.9 vs. 15.8 % , p = 0.003 ) .\
RESULTS	The intervention yielded a significantly greater decrease in the number of days smoked and in cigarettes smoked per day .\
RESULTS	The 30-day abstinence rate at two months post baseline was 2.5 times greater in the intervention group ; the difference was not significant ( 26.1 vs. 10.5 % , p = 0.12 ) .\
CONCLUSIONS	The Video Doctor plus provider cueing is an efficacious adjunct to routine prenatal care by promoting provider advice and smoking reduction among pregnant smokers .\
\
###24114811\
BACKGROUND	Oral mucositis ( OM ) is a significant toxicity of induction chemotherapy for locally advanced head and neck cancer ( LAHNC ) .\
BACKGROUND	The safety and tolerability of AG013 , an oral rinse containing recombinant Lactococcus lactis secreting mucosal protectant human trefoil factor 1 ( hTFF1 ) , was evaluated in a phase 1b study in LAHNC subjects who received induction with cisplatin , 5-fluorouracil , with or without docetaxel .\
BACKGROUND	Preliminary efficacy data were also obtained .\
METHODS	A total of 25 of 52 LAHNC subjects who were followed during induction cycle 1 developed ulcerative oral mucositis ( UOM ; World Health Organization grade > 2 ) and were randomized to AG013 : placebo ( 5:2 ratio ) for cycle 2 .\
METHODS	Dosing schedules of 1 , 3 , or 6 times daily were evaluated ( 2 10 ( 11 ) , 6 10 ( 11 ) , and 1.2 10 ( 12 ) colony forming units per day , respectively ) .\
METHODS	OM was evaluated daily from cycle 2 , day 1 through 14 , using World Health Organization criteria .\
METHODS	Pharmacokinetic assessment was also conducted .\
RESULTS	AG013 bacteria were not detected in blood .\
RESULTS	Oral live AG013 bacterial and hTFF1 levels in saliva and oral mucosa were equivalent among treatment groups .\
RESULTS	The most frequently occurring adverse events were nausea , oral pain , fatigue , diarrhea , and mucosal inflammation .\
RESULTS	Only 12 % ( 3 of 25 adverse events ) , mainly nausea , were attributed to the investigational medicinal product : AG013 or placebo .\
RESULTS	Efficacy analysis showed a 35 % reduction in percentage of days with UOM in AG013-subjects versus placebo .\
RESULTS	All placebo subjects experienced 2 days of UOM , whereas 29 % of AG013 subjects had UOM for 0 or 1 day .\
RESULTS	AG013 use resulted in fewer unscheduled office and emergency room visits .\
RESULTS	No differences were noted in mouth and throat soreness , opioid use , or gastrostomy tube placement .\
CONCLUSIONS	AG013 was safe and well tolerated .\
CONCLUSIONS	Preliminary efficacy data support further study .\
\
###12679757\
BACKGROUND	Cerebrovascular accidents ( CVAs ) , transient ischemic attacks ( TIAs ) , and peripheral arterial disease ( PAD ) frequently coexist with coronary artery disease ( CAD ) and were previously reported to adversely affect the prognosis of patients with chronic CAD .\
METHODS	We examined the effect of prior CVA/TIA or PAD ( extra-cardiac vascular disease [ EVD ] ) on the outcome of 10,281 patients with acute coronary syndromes enrolled in the Orbofiban in Patients with Unstable Coronary Syndromes-Thrombolysis in Myocardial Infarction ( OPUS-TIMI ) 16 trial of the oral glycoprotein IIb/IIIa antagonist orbofiban plus aspirin versus aspirin alone .\
METHODS	We evaluated mortality , recurrent cardiac events , and stroke and used multivariate analysis to control for differences in baseline characteristics .\
RESULTS	Patients with EVD were older , had more coronary risk factors , had a history of CAD , and received more intensive medical treatment at baseline .\
RESULTS	The acute event in these patients was more often unstable angina pectoris and less commonly Q-wave myocardial infarction .\
RESULTS	With coronary angiography , patients with prior EVD more often had multivessel disease .\
RESULTS	During the 10 months of follow-up , the presence of EVD was predictive of an increased hazard of death , reinfarction , recurrent ischemia , stroke , and a composite of these events .\
RESULTS	Despite the increased severity of the CAD and increased risk of events , patients with EVD were treated less frequently with beta-blockers and more frequently with calcium blockers .\
RESULTS	Despite patients with EVD having a 45 % higher incidence of hypercholesterolemia , lipid-lowering agents were prescribed in a similar percentage of patients as patients without EVD .\
CONCLUSIONS	In patients with acute coronary syndromes , the presence of prior CVA , TIA , or PAD is associated with more extensive CAD and worse outcome .\
CONCLUSIONS	These patients appear to receive less aggressive treatment , which may explain , at least in part , their worse outcome .\
\
###25223378\
BACKGROUND	In spite of several studies , the impact of homocysteine level and folic acid supplementation on bone metabolism is yet to be recognized .\
BACKGROUND	In this registered clinical trial ( IRCT2014042217385N1 ) , we aimed to find out the power of 6-month folic acid supplementation on homocysteine level and bone metabolism .\
METHODS	Forty postmenopausal osteoporotic women ( 50 to 87years ) were enrolled in the study .\
METHODS	All participants were randomized to receive folic acid 1mg ( n = 17 ) or placebo ( n = 14 ) .\
METHODS	At baseline , 3months , and finally 6months post intervention , the level of homocysteine , vitamin B12 , and bone biomarkers were measured .\
RESULTS	Both groups were similar at baseline .\
RESULTS	The homocysteine decreased in both groups but statistically non-significant ( P > 0.05 ) .\
RESULTS	The changes of the serum level of vitamin B12 , osteocalcin , and cross laps were significant between groups after 6months ( P0 .05 ) .\
CONCLUSIONS	The trend of changes of bone biomarkers after 6months folic acid supplementation shows that homocysteine concentration and/or folic acid supplementation have impact on the rate of bone metabolism .\
CONCLUSIONS	However , further investigations by larger sample size and differentiating age and gender are still needed to clarify the exact role of folate , homocysteine and vitamin B12 .\
\
###23740633\
BACKGROUND	Intervention strategies for ` prevention of conditions leading to the need for long-term care ' ( prevention of long-term care status ) that have physically and mentally proven effects are needed .\
OBJECTIVE	The aim of this randomized controlled trial was to clarify the physical and psycho-social effects of an exercise program , easily performed at home and in communities using inexpensive equipments for prevention of long-term care status .\
METHODS	A cluster of 196 participants was randomly assigned to the intervention group that performed the exercise for 8weeks and the control group .\
METHODS	Both groups received tests for physical strength and endurance and interview surveys at baseline and 9weeks later .\
METHODS	The exercise consisted of six types of stretching exercises , six types of muscle strength training , two types of balance training and toe stretching in order to improve ambulatory , balance and stability ability of elderly .\
METHODS	The physical aspects of the subjects were assessed by balance assessment , activities of daily living ( ADL ) , timed up-and-go test ( TUG ) , functional reach test ( FRT ) , sit and reach .\
METHODS	The psycho-social aspects were assessed by the fall prevention self-efficacy scale ( FPSE ) , instrumental activities of daily living ( IADL ) , degree of houseboundness , and assessment at the end of intervention .\
RESULTS	The intervention and control groups consisted of 101 and 81 persons at the baseline and 92 and 74 after intervention , respectively .\
RESULTS	The intervention group showed significantly higher values than the control group after exercise in the FRT , the FPSE and degree of houseboundness .\
CONCLUSIONS	This exercise program can promote physical and psycho-social aspects of the health in the elderly , and may reduce the amount of care that the elderly require .\
\
###23582109\
OBJECTIVE	The aim of this study was to compare the relative efficacy of baclofen and self-applied transcutaneous electrical nerve stimulation ( TENS ) for the treatment of spasticity in the lower extremities in multiple sclerosis ( MS ) .\
METHODS	A randomized controlled clinical trial was conducted from September 2010 to June 2011 .\
METHODS	Fifty-two patients with MS presenting muscle spasm in the leg at 20-50 years of age were randomly allocated to receive a four-week treatment course of either baclofen ( 10 mg twice daily , increasing over three weeks to 25 mg ) or self-applied TENS .\
METHODS	Response to treatment was assessed at four weeks after commencement of the intervention by modified Ashworth scale ( MAS ) .\
RESULTS	Spasticity decreased in both groups .\
RESULTS	Of the 26 people treated with TENS , the mean ( standard deviation ( SD ) ) MAS decreased from 1.77 ( 0.29 ) at baseline to 0.73 ( 0.70 ) at the four-week follow-up ( P < 0.001 ) .\
RESULTS	Correspondingly , in the 26 people treated with baclofen , the mean ( SD ) MAS decreased from 1.73 ( 0.38 ) to 1.15 ( 0.63 ) ( P < 0.001 ) .\
RESULTS	The mean difference in MAS score at the four-week follow-up was significantly lower in the TENS group than the baclofen group ( mean difference -0.42 ; 95 % CI , -0.79 , -0.05 ; P < 0.05 ) .\
CONCLUSIONS	This study demonstrates that both baclofen and TENS can be effective in reducing MS-related spasticity .\
CONCLUSIONS	The mean MAS score was significantly lower in the TENS group .\
CONCLUSIONS	However given the side-effect profile of baclofen , TENS may have some benefits over baclofen .\
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###11091263\
BACKGROUND	The increasing number of children attending day care centres ( DCCs ) in industrialized countries has refocused attention on the occurrence of infections and infectious diseases in these settings .\
OBJECTIVE	To evaluate the agreement between two methods ( parent method vs. educator method ) for reporting the occurrence of respiratory and diarrhoeal infections .\
METHODS	Fifty-two DCCs in Quebec , Canada , participated .\
METHODS	Both educators and parents were invited to fill in calendars on which they would indicate the occurrence of colds and diarrhoea .\
METHODS	For the parents ' method , parents were telephoned biweekly to record their calendar information .\
METHODS	For the educators ' method , educators returned their calendar pages monthly ( following prompting by phone , when necessary ) .\
RESULTS	Three hundred and thirty-three parents of toddlers participated in the 15-month reporting period between September 1996 and November 1997 .\
RESULTS	The average agreement between the two methods was low ( 13.5 % for colds and 9.8 % for diarrhoea ) .\
RESULTS	Overall estimates of the incidence rates of respiratory and diarrhoeal infections based on parents ' method were higher than those based on educators ' method .\
CONCLUSIONS	Parents ' data lead to larger estimations of incidence rates and are probably more valid than educators ' data .\
\
###16155268\
BACKGROUND	Resistant starch may modulate insulin sensitivity , although the precise mechanism of this action is unknown .\
OBJECTIVE	We studied the effects of resistant starch on insulin sensitivity and tissue metabolism .\
METHODS	We used a 4-wk supplementation period with 30 g resistant starch/d , compared with placebo , in 10 healthy subjects and assessed the results by using arteriovenous difference methods .\
RESULTS	When assessed by euglycemic-hyperinsulinemic clamp , insulin sensitivity was higher after resistant starch supplementation than after placebo treatment ( 9.7 and 8.5 x 10 ( -2 ) mg glucose x kg ( -1 ) x min ( -1 ) x ( mU insulin/L ) ( -1 ) , respectively ; P = 0.03 ) ; insulin sensitivity during the meal tolerance test ( MTT ) was 33 % higher ( P = 0.05 ) .\
RESULTS	Forearm muscle glucose clearance during the MTT was also higher after resistant starch supplementation ( P = 0.03 ) despite lower insulin concentrations ( P = 0.02 ) ; glucose clearance adjusted for insulin was 44 % higher .\
RESULTS	Subcutaneous abdominal adipose tissue nonesterified fatty acid ( NEFA ; P = 0.02 ) and glycerol ( P = 0.05 ) release were lower with resistant starch supplementation , although systemic NEFA concentrations were not significantly altered .\
RESULTS	Short-chain fatty acid concentrations ( acetate and propionate ) were higher during the MTT ( P = 0.05 and 0.01 , respectively ) , as was acetate uptake by adipose tissue ( P = 0.03 ) .\
RESULTS	Fasting plasma ghrelin concentrations were higher with resistant starch supplementation ( 2769 compared with 2062 pg/mL ; P = 0.03 ) , although postprandial suppression ( 40-44 % ) did not differ significantly .\
RESULTS	Measurements of gene expression in adipose tissue and muscle were uninformative , which suggests effects at a metabolic level .\
RESULTS	The resistant starch supplement was well tolerated .\
CONCLUSIONS	These results suggest that dietary supplementation with resistant starch has the potential to improve insulin sensitivity .\
CONCLUSIONS	Further studies in insulin-resistant persons are needed .\
\
###9914571\
OBJECTIVE	Our goal was to evaluate the efficacy and side effects of danazol 200 mg daily given only in the luteal phase of the menstrual cycle to treat premenstrual syndrome and premenstrual mastalgia .\
METHODS	We conducted a randomized , double-blind , placebo-controlled study of 3 menstrual cycles in a postgraduate medical school and National Health Service hospital .\
METHODS	The subjects of the study were 100 women who had been referred to the premenstrual syndrome clinic at the North Staffordshire Hospital for the management of premenstrual syndrome and premenstrual breast pain .\
METHODS	Outcome measures for the study included assessment of improvement in symptoms measured by specific daily visual analogue scales for 4 principal symptoms of premenstrual syndrome and for premenstrual mastalgia and assessment of side effects and adverse events .\
RESULTS	Significant improvement in symptoms was seen in visual analog scores for mastalgia in months 1 ( P = .03 ) , 2 ( P = .004 ) , and 3 ( P = .01 ) of the study during active therapy compared with placebo .\
RESULTS	No improvement was seen for any other symptom or for the global premenstrual syndrome score .\
RESULTS	Side effects on danazol and on placebo were equal and minimal .\
CONCLUSIONS	Luteal phase-only danazol is not effective for the treatment of the general symptoms of premenstrual syndrome but appears highly effective for the relief of premenstrual mastalgia .\
CONCLUSIONS	This approach to therapy is associated with few side effects .\
CONCLUSIONS	Studies of cyclic mastalgia using strict diagnostic criteria are required to see whether the freedom from symptomatic side effects is found in longer-term studies and to determine whether such a regimen avoids potentially detrimental effects on the lipid status .\
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###8742147\
OBJECTIVE	To find the frequency and seasonal variability of the infectious diseases detected over a year .\
METHODS	Observational prospective study .\
METHODS	Primary care centre .\
METHODS	Simple multi-stage random sampling of the patients over 14 seen on demand at general medical clinics and the Casualty department between June 1991 and May 1992 .\
RESULTS	Out of 49,193 attendances during the study period , the attendance sample was 2,523 , of which 474 ( 18.8 % ; CI : 17.3-20 .3 % ) were for infectious conditions .\
RESULTS	Average age of these 474 was 39 ( SD : 19.17 ) ; 55 % were women .\
RESULTS	Frequency of respiratory infections was 64.1 % ( CI : 59.8-68 .5 % ) .\
RESULTS	The correlation coefficient between respiratory infections and the total number of infections was 0.94 ( R2 = 0.89 ) .\
RESULTS	The frequency of infections oscillated between 29 % ( CI : 23-35 % ) in February and 10 % ( CI : 5.8-14 .5 % ) in May .\
CONCLUSIONS	Infectious conditions account for a considerable percentage of the total number of primary care attendances .\
CONCLUSIONS	There is a seasonal variation in infections , which is mainly due to respiratory infections .\
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###17217741\
OBJECTIVE	To identify the optimal intensity of anticoagulation with warfarin in patients with nonvalvular atrial fibrillation by studying the relation between the thromboembolic and hemorrhagic events .\
METHODS	Nonvalvular atrail fibrillation patients randomized to receive adjusted-dose warfarin [ international normalized ratio ( INR ) 2.0 to 3.0 ] were included .\
METHODS	The initial dose of warfarin was 2 mg and the dose was then adjusted to target at INR 2.0-3 .0 .\
METHODS	Thromboembolic events and bleeding events were identified during follow-up .\
RESULTS	Of the 335 patients , 204 ( 60.9 % ) were male .\
RESULTS	Mean age was ( 62.6 + / - 10.3 ) years .\
RESULTS	Sixty-six percent of all the patients had at least one risk factor for thromboembolism .\
RESULTS	The median follow-up period was 19 months ( range 2-24 months ) .\
RESULTS	Among the 3482 INRs measured during the study , 2378 were in the target range .\
RESULTS	Of the 19 thromboembolic events occurred during warfarin therapy , 15 occurred with INR less than 2.0 .\
RESULTS	The independent risk factors for thromboembolic events during warfarin therapy were age > 75 years , history of stroke , left ventricular ejection fraction ( LVEF ) < 0.40 and INR > 2.0 .\
RESULTS	The incidence of bleeding events were 6.9 % , including 5 cases ( 1.5 % ) of minor bleeding and 18 cases ( 5.4 % ) of major bleeding .\
RESULTS	The independent risk factors for the hemorrhage in warfarin treatment are age > 75 years , systolic blood pressure > or = 160 mm Hg , elevated serum creatinine level INR > 3.0 .\
RESULTS	INR of 2.0 to 3.0 was associated with the lowest combined rate of bleeding and thromboembolism .\
CONCLUSIONS	INR > 3.0 should be avoided to minimize the bleeding complications .\
CONCLUSIONS	Under intense monitoring , adjusted-dose warfarin ( INR 2.0 - 3.0 ) is effective and safe for the moderate to high risk nonvalvular atrial fibrillation patients .\
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###16687205\
OBJECTIVE	To investigate the effects of darifenacin controlled-release ( CR ) and oxybutynin extended-release ( ER ) on cognitive function ( particularly memory ) in older subjects .\
METHODS	Healthy subjects ( n = 150 ) > / = 60 years were randomised to darifenacin , oxybutynin ER or placebo in a multicentre , double-blind , double-dummy , parallel-group , 3-week study .\
METHODS	Doses were administered according to US labels : oxybutynin ER 10mg once daily ( od ) , increasing to 15mg od then 20mg od by week 3 ; darifenacin 7.5 mg od in weeks 1 and 2 , then 15mg od in week 3 .\
METHODS	The primary end point was accuracy on the Name-Face Association Test ( delayed recall ) at week 3 .\
RESULTS	Results of the Name-Face Association Test at week 3 showed no significant difference between darifenacin and placebo on delayed recall ( mean difference , -0.06 , p = 0.908 ) .\
RESULTS	In contrast , oxybutynin ER resulted in memory impairment , with significantly lower scores than placebo and darifenacin ( mean differences , -1.30 , p = 0.011 and -1.24 , p = 0.022 , respectively ) for delayed recall on the Name-Face Association Test at week 3 .\
RESULTS	Additional tests of delayed recall indicated significant memory impairment with oxybutynin ER versus placebo at certain time points , whereas darifenacin was similar to placebo .\
RESULTS	No between-treatment differences were detected in self-rated memory , demonstrating that subjects were unaware of memory deterioration .\
CONCLUSIONS	While darifenacin had no significant effects on memory versus placebo , oxybutynin ER caused significant memory deterioration ( magnitude of effect comparable to brain aging of 10 years ) .\
CONCLUSIONS	The results also demonstrate that subjects may not recognise/report memory deterioration .\
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###15765890\
BACKGROUND	The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome .\
BACKGROUND	No study , however , has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease ( CHD ) in hypertensive patients who are not conventionally deemed dyslipidaemic .\
METHODS	Of 19 342 hypertensive patients ( aged 40-79 years with at least three other cardiovascular risk factors ) randomised to one of two antihypertensive regimens in the Anglo-Scandinavian Cardiac Outcomes Trial , 10,305 with nonfasting total cholesterol concentrations 6.5 mmol/L or less were randomly assigned additional atorvastatin 10 mg or placebo .\
METHODS	These patients formed the lipid-lowering arm of the study .\
METHODS	We planned follow-up for an average of 5 years , the primary endpoint being non-fatal myocardial infarction and fatal CHD .\
METHODS	Data were analysed by intention to treat .\
RESULTS	Treatment was stopped after a median follow-up of 3.3 years .\
RESULTS	By that time , 100 primary events had occurred in the atorvastatin group compared with 154 events in the placebo group ( hazard ratio 0.64 [ 95 % CI 0.50-0 .83 ] , p = 0.0005 ) .\
RESULTS	This benefit emerged in the first year of follow-up .\
RESULTS	There was no significant heterogeneity among prespecified subgroups .\
RESULTS	Fatal and non-fatal stroke ( 89 atorvastatin vs 121 placebo , 0.73 [ 0.56-0 .96 ] , p = 0.024 ) , total cardiovascular events ( 389 vs 486 , 0.79 [ 0.69-0 .90 ] , p = 0.0005 ) , and total coronary events ( 178 vs 247 , 0.71 [ 0.59-0 .86 ] , p = 0.0005 ) were also significantly lowered .\
RESULTS	There were 185 deaths in the atorvastatin group and 212 in the placebo group ( 0.87 [ 0.71-1 .06 ] , p = 0.16 ) .\
RESULTS	Atorvastatin lowered total serum cholesterol by about 1.3 mmol/L compared with placebo at 12 months , and by 1.1 mmol/L after 3 years of follow-up .\
CONCLUSIONS	The reductions in major cardiovascular events with atorvastatin are large , given the short follow-up time .\
CONCLUSIONS	These findings may have implications for future lipid-lowering guidelines .\
\
###7936512\
OBJECTIVE	To determine whether depot leuprolide is effective in premenstrual syndrome ( PMS ) and whether symptom type or severity affects therapeutic or hormonal responses and the incidence of adverse events .\
METHODS	Twenty-five women who met strict diagnostic criteria for PMS completed a double-blind , placebo-controlled , 6-month crossover trial at a university medical center .\
METHODS	Depot leuprolide ( 3.75 mg/month ) or saline was administered intramuscularly for three consecutive treatment cycles .\
METHODS	Efficacy , adverse events , and hormone concentrations were assessed at each visit .\
METHODS	Repeated-measures analysis of variance was used to analyze continuous data , and ordinal and binary data were analyzed using nonparametric techniques .\
RESULTS	Depot leuprolide treatment was significantly more effective than placebo on all rating scales .\
RESULTS	Irritability , neurologic symptoms , breast tenderness , and fatigue were most responsive to treatment .\
RESULTS	Symptoms were reduced to follicular phase levels only in women without premenstrual depression .\
RESULTS	Those with moderate premenstrual depression improved but remained clinically symptomatic , whereas the group with severe premenstrual depression showed no improvement on any efficacy measure .\
RESULTS	Adverse events were lowest in those without premenstrual depression and highest in those with severe depression .\
RESULTS	Leuprolide suppressed estradiol and progesterone in most premenstrual depression groups but had varying effects on gonadotropins .\
CONCLUSIONS	Leuprolide treatment reduced both behavioral and physical symptoms and was well tolerated in the absence of severe premenstrual depression .\
CONCLUSIONS	Women should be evaluated for depression severity before receiving a GnRH agonist .\
CONCLUSIONS	The differential response to leuprolide suggests that it may possess diagnostic value in determining distinct subtypes of PMS .\
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###8457044\
BACKGROUND	Although pulse oximetry is currently in widespread use , there are few data documenting improvement in patient outcome as a result of the use of oximetry .\
BACKGROUND	The authors describe the study design , patient demographic findings , data validation , pulse oximetry failure rate , and overall postoperative complication rates in the first large prospective randomized multicenter clinical trial on perioperative pulse oximetry monitoring .\
METHODS	In five Danish hospitals , by random assignment , monitoring did or did not include pulse oximetry for patients 18 yr of age and older , whether scheduled for elective or emergency operations , or for regional or general anesthesia , except during cardiac and neurosurgical procedures .\
METHODS	Operational definitions were established for perioperative events and postoperative complications .\
METHODS	The data were collected preoperatively , during anesthesia , in the postanesthesia care unit , and until the day of discharge from the hospital or the seventh postoperative day .\
RESULTS	Of 20,802 patients , 10,312 were assigned to the oximetry group and 10,490 , to the control group .\
RESULTS	In general , the demographic data , patient factors , and anesthetic agents used were distributed evenly .\
RESULTS	A slight intergroup difference was found in the distribution of age , duration of surgery , some types of surgery , and some types of anesthesia .\
RESULTS	The total failure rate of the oximetry was 2.5 % , but it increased to 7.2 % in patients with American Society of Anesthesiologists physical status 4 ( P < 0.00001 ) .\
RESULTS	In 14.9 % of the patients , one or more events occurred in the operating room and 13.5 % in the postanesthesia care unit .\
RESULTS	The overall postoperative complication rate was 9.7 % .\
RESULTS	The total rates of cardiovascular and respiratory complications were 2.78 % and 3.50 % , respectively .\
RESULTS	Within the first seven postoperative days , 0.47 % of the patients died .\
RESULTS	Anesthesia was not thought to have been solely responsible for any death , but in 7 patients ( 1 per 3,365 ) , it was a possible contributory factor .\
CONCLUSIONS	Despite the finding of a few significant inter-group differences , the randomization was well balanced with a high validity of data .\
CONCLUSIONS	The overall postoperative complication rate was similar to that in other recent morbidity and mortality studies .\
\
###22957320\
BACKGROUND	Physical examination is a crucial part in medical student curricula , but a decline in physical examination skills was noted in the last two decades .\
BACKGROUND	The benefic role of ultrasonography ( US ) as an adjuvant method for clinical examination was evaluated in many studies , but there are different approaches among countries and universities .\
BACKGROUND	The aim of this study was to evaluate the role of US in learning physical exam in 3rd year medical students .\
METHODS	One hundred and four 3rd year medical students were randomly enrolled .\
METHODS	They were divided first in two equal groups ( I and II , with and without US , by rotation ) and then in smaller groups of 8-9 students .\
METHODS	Pairs between smaller groups belonging to group I and II were randomly established in order to be trained and evaluated by the same instructor .\
METHODS	We verified the influence of US on the correctness of thyroid palpation , lung percussion ( inferior limit of the lung ) , and liver size estimation .\
METHODS	They received no special training on US .\
METHODS	After the learning sessions ( four sessions , one hour each ) a questionnaire was applied to each student .\
RESULTS	For thyroid palpation , there were no significant differences regarding the gland dimensions .\
RESULTS	For lung and liver palpation the results showed better results for some points in groups using US as adjuvant , but the most significant difference regarded the appreciation of self confidence ( in favor of US-groups ) .\
RESULTS	The majority of the students using US appreciated as very useful the informations provided by US .\
RESULTS	Also , we found a clear improvement in detecting the upper limit of the liver comparing with the inferior limit of the lung , as result of better clinical skills .\
CONCLUSIONS	The results from this pilot study proved the utility of US in learning clinical examination .\
CONCLUSIONS	The students can better understand the regional anatomy and can confirm immediately the physical findings .\
CONCLUSIONS	It is important for students to reach a certain level of knowledge regarding physical exam to better understand the role of US .\
CONCLUSIONS	Overall , we can state that use of US in the daily clinical examination teaching greatly improved the students ' clinical examination abilities and that is a strong argument for integrating basic US into the medical school curriculum .\
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###8346498\
BACKGROUND	Topical application of nicotine and stimulation of tachykinin containing sensory nerves have been shown to produce mucosal exudation of plasma and derangement of the epithelial lining in guinea pig and rat airways .\
BACKGROUND	If this occurred in man these effects might contribute to the pathogenesis of airway disease .\
BACKGROUND	This study , performed in healthy volunteers without atopy , examined whether nicotine affects the plasma exudation response and the mucosal absorption permeability of the human nasal airway .\
METHODS	The acute effects of increasing topical doses of nicotine ( 0.08-2 .0 mg ) were examined ( n = 8 ) on nasal symptoms ( pain ) , mucosal exudation of plasma ( albumin ) , mucosal secretion of mucin ( fucose ) , and mucosal exudative responsiveness ( histamine induced mucosal exudation of albumin ) .\
METHODS	A separate placebo controlled study was carried out to determine whether frequent applications of the high dose of nicotine ( 2.0 mg given eight times daily for nine days ) had any deleterious effects on the airway mucosa detectable as altered responses to histamine challenge .\
METHODS	Both mucosal exudation of plasma ( n = 12 ) and mucosal absorption of chromium-51 labelled EDTA ( n = 8 ) were thus examined in nasal airways exposed to both nicotine and histamine .\
RESULTS	Nicotine caused nasal pain and produced dose dependent mucosal secretion of fucose but failed to produce any mucosal exudation of albumin .\
RESULTS	The exudative responsiveness to histamine was , indeed , decreased when the challenge was performed immediately after administration of acute doses of nicotine , whereas the responsiveness was unaffected when histamine challenges were carried out during prolonged treatment with nicotine .\
RESULTS	The nasal mucosal absorption of 51Cr-EDTA in the presence of histamine did not differ between subjects receiving either placebo or nicotine treatment for nine days .\
CONCLUSIONS	The results indicate that nicotine applied to the human airway mucosa produces pain and secretion of mucin , but inflammatory changes such as mucosal exudation of plasma and epithelial disruption may not be produced .\
CONCLUSIONS	Neurogenic inflammatory responses , which are so readily produced in guinea pig and rat airways , may not occur in human airways .\
\
###25009161\
BACKGROUND	The risk of persistent tardive dyskinesia ( TD ) was compared in patients with acute psychosis or agitation aged 55 years or older who were treated with olanzapine ( OLZ ) or conventional antipsychotic ( CNV ) drug therapy .\
METHODS	Patients without TD were randomized to treatment with OLZ ( 2.5-20 mg/d ; n = 150 ) or CNV ( dosed per label ; n = 143 ) .\
METHODS	Following a 6-week drug tapering/initiation period , patients without TD were treated with OLZ or CNV for up to 1 year .\
METHODS	The a priori defined primary outcome end point was persistent TD defined as Abnormal Involuntary Movement Scale ( AIMS ) scores = 2 on at least 2 items or 3 on at least 1 item ( items 1-7 ) lasting at least for 1 month ( Criterion A ) .\
METHODS	Post hoc analyses assessed persistent TD meeting the criterion of moderate severity defined as AIMS score 3 on at least 1 item persisting for 1 month ( Criterion B ) and probable TD defined as elevated AIMS scores ( Criterion A or B ) not persisting for 1 month .\
METHODS	Treatment groups were compared using Kaplan-Meier curve with log-rank exact test .\
RESULTS	On average , patients were 78 years of age ; the predominant diagnosis was dementia ( 76.7 % in the OLZ group and 82.5 % in the CNV group ) .\
RESULTS	Approximately , 40.6 % of patients in the CNV group received haloperidol .\
RESULTS	No significant difference in time to developing persistent TD was observed during treatment with OLZ or CNV ( cumulative incidence : OLZ , 2.5 % [ 95 % confidence interval [ 95 % CI ] : 0.5-7 .0 ] ; CNV , 5.5 % [ 95 % CI : 2.1-11 .6 ] , P = .193 ) .\
RESULTS	The exposure-adjusted event rates per 100 person-years were not significantly different between treatment groups : OLZ ( 2.7 ) and CNV ( 6.3 ; ratio : 0.420 ; 95 % CI : 0.068-1 .969 ) .\
RESULTS	Post hoc analyses revealed a significantly lower risk of at least moderately severe persistent TD persisting for 1 month ( P = .012 ) and probable TD not persisting for 1 month ( Criterion A , P = .030 ; Criterion B , P = .048 ) in OLZ-treated patients .\
RESULTS	For those patients without significant extrapyramidal symptoms at baseline , significantly more patients in the CNV treatment group developed treatment-emergent parkinsonism than for patients in the OLZ treatment group ( CNV : 70 % , 35 of 50 patients ; OLZ 44 % , 25 of 57 patients ; P = .011 ) .\
RESULTS	No significant difference between the groups was observed for treatment-emergent akathisia ( CNV : 6 % , 7 of 117 patients ; OLZ : 10 % , 13 of 130 patients ; P = .351 ) .\
CONCLUSIONS	The cumulative incidence of persistent TD was low and the risk of persistent TD did not differ significantly among predominantly older adult patients having dementia with acute psychosis or agitation treated with OLZ or CNV .\
\
###19412117\
OBJECTIVE	To examine the long-term effects of individual antiretroviral drugs on body composition among 416 persons initiating antiretroviral therapy ( ART ) .\
METHODS	In a substudy of a clinical trial of persons initiating ART , changes in body composition attributable to individual ART were examined .\
METHODS	ARTs assessed were as follows : indinavir , ritonavir , nelfinavir , efavirenz , nevirapine , stavudine ( d4T ) , zidovudine ( ZDV ) , lamivudine ( 3TC ) , didanosine , and abacavir .\
METHODS	Skinfolds and circumferences were measured at baseline and every 4 months .\
METHODS	Mid arm , mid thigh , and waist subcutaneous tissue areas and nonsubcutaneous tissue areas were calculated .\
METHODS	Rates of change per year of exposure to each individual ART drug were determined using multivariate longitudinal regression .\
RESULTS	d4T and ZDV use was associated with losses in subcutaneous tissue area and skinfold thickness .\
RESULTS	3TC use was associated with gains in all subcutaneous tissue areas and skinfold thickness , whereas abacavir use was associated with an increase in waist subcutaneous tissue area .\
RESULTS	Indinavir was associated with gains in waist subcutaneous tissue area , whereas indinavir , efavirenz , and nevirapine were associated with increases in upper back skinfolds .\
RESULTS	d4T use was also associated with increases in all nonsubcutaneous tissue areas ; 3TC use was associated with the greatest increase in waist nonsubcutaneous tissue area .\
CONCLUSIONS	In this prospective nonrandomized evaluation , the nucleoside reverse transcriptase inhibitors d4T and ZDV were associated with decreases in subcutaneous tissue areas , whereas 3TC use was associated with increased subcutaneous tissue areas and waist nonsubcutaneous tissue area .\
\
###19628206\
OBJECTIVE	To compare the efficacy and adverse effects of sublingual misoprostol , intravenous oxytocin , and intravenous methylergometrine in active management of the third stage of labor ( AMTSL ) .\
METHODS	A double-blind randomized trial of 300 women with a healthy singleton pregnancy allocated into 4 groups to receive either : 400 microg or 600 microg of sublingual misoprostol , 5 IU of intravenous oxytocin , or 200 microg of intravenous methylergometrine .\
METHODS	The primary outcome measure was blood loss in the third and fourth stage of labor ; secondary measures were duration of the third stage of labor , changes in hemoglobin levels , and adverse effects .\
RESULTS	Patients who received 600 microg of misoprostol had the lowest blood loss ( 96.05 + / -21.1 mL ) , followed by 400 microg of misoprostol ( 126.24 + / -49.3 mL ) , oxytocin ( 154.7 + / -45.7 mL ) , and methylergometrine ( 223.4 + / -73.7 mL ) ( P < 0.01 ) .\
RESULTS	Shortest mean duration of the third stage of labor ( 5.74 minutes ) was with 600 microg of misoprostol , while methylergometrine had the longest ( 6.83 minutes ) ( P < 0.05 ) .\
RESULTS	Pyrexia was observed in the misoprostol groups , and raised blood pressure in the methylergometrine group ( P < 0.001 ) .\
RESULTS	The 24-hour postpartum hemoglobin level was similar among the groups ( P > 0.05 ) .\
CONCLUSIONS	Administration of 600 microg of sublingual misoprostol was more effective than 400 microg of misoprostol , intravenous oxytocin , and intravenous methylergometrine for AMTSL .\
\
###21095484\
BACKGROUND	The reduction in plasma LDL-C concentrations with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor ( statin ) therapy has been reported to reduce cardiovascular risk and mortality in individuals with or without preexisting coronary artery disease and elevated LDL-C concentrations .\
BACKGROUND	Atorvastatin is a statin used for lowering LDL-C concentrations .\
BACKGROUND	A generic formulation of atorvastatin is being developed in Korea .\
BACKGROUND	This study was undertaken for the purposes of marketing the generic formulation .\
OBJECTIVE	This study was designed to compare the efficacy and tolerability of a generic formulation of atorvastatin 20 mg/d versus a branded formulation at the same dosage in hypercholesterolemic Korean adults at high risk for cardiovascular events .\
METHODS	This 8-week , multicenter , randomized , double-blind , double-dummy study was conducted at 10 clinical centers in Korea between September 2008 and May 2009 .\
METHODS	Male and female patients aged 20 to 85 years at high risk for cardiovascular events ( defined as an elevated LDL-C concentration [ 100 mg/dL ] ) were enrolled .\
METHODS	Eligible patients were randomly assigned to receive generic or branded atorvastatin 20 mg once daily for 8 weeks .\
METHODS	The primary end point was the percentage change from baseline to 8 weeks in LDL-C concentration .\
METHODS	Secondary end points were the percentage changes from baseline in total cholesterol ( TC ) , triglycerides ( TG ) , HDL-C , apolipoprotein ( apo ) A1 and B , and high-sensitivity C-reactive protein concentrations ; small , dense LDL ( sdLDL ) fraction ; and tolerability .\
METHODS	Tolerability was assessed using physical examination , laboratory testing , and by recording adverse events ( AEs ) at each visit .\
METHODS	An additional secondary end point was the proportion of patients who achieved an LDL-C goal of < 100 mg/dL .\
RESULTS	A total of 244 patients were randomized to treatment , and 33 patients were withdrawn from the study ( 9 patients did not receive the study medication , 11 patients due to AEs , and 13 patients due to withdrawal of consent ) .\
RESULTS	A total of 211 patients completed the study ( 50.7 % male ; 100 % Asian ; mean [ SD ] age , 61.7 [ 9.2 ] years ) ( 106 patients in the group that received Accepted for publication October 5 , 2010 .\
RESULTS	the generic formulation and 105 patients in the group that received the branded formulation ) .\
RESULTS	LDL-C concentrations were reduced from the baseline by 44 % and 46 % after 8 weeks of treatment with the generic and branded formulations , respectively ( P = NS ) .\
RESULTS	The percentage changes from baseline to study end in HDL-C , TC , TG , apo A1 , apo B , and hsCRP concentrations and sdLDL fraction the proportions of patients who achieved the LDL-C goal between the 2 groups did not reach statistical significance .\
RESULTS	The most commonly reported events were hepatobiliary laboratory abnormality ( 1.7 % ) , general somatic discomfort ( 1.7 % ) , and epigastric pain ( 0.8 % ) in the group that received the generic formulation , and myalgia ( 1.7 % ) , epigastric pain ( 0.9 % ) , and elevation of creatinine phosphokinase ( 0.9 % ) in the group that received the branded formulation .\
RESULTS	No serious AEs were reported in either group .\
CONCLUSIONS	After 8 weeks of treatment , the differences in the LDL-C-lowering effects between the generic and branded formulations of atorvastatin 20 mg/d did not reach statistical significance in these Korean patients at high risk for cardiovascular events .\
CONCLUSIONS	Both formulations were generally well tolerated .\
\
###23855376\
BACKGROUND	Work-related stress is associated with a variety of mental and emotional problems and can lead to substantial economic costs due to lost productivity , absenteeism or the inability to work .\
BACKGROUND	There is a considerable amount of evidence on the effectiveness of traditional face-to-face stress-management interventions for employees ; however , they are often costly , time-consuming , and characterized by a high access threshold .\
BACKGROUND	Web-based interventions may overcome some of these problems yet the evidence in this field is scarce .\
BACKGROUND	This paper describes the protocol for a study that will examine the efficacy and cost-effectiveness of a web-based guided stress-management training which is based on problem solving and emotion regulation and aimed at reducing stress in adult employees .\
METHODS	The study will target stressed employees aged 18 and older .\
METHODS	A randomized controlled trial ( RCT ) design will be applied .\
METHODS	Based on a power calculation of d = .35 ( 1 - of 80 % , = .05 ) , 264 participants will be recruited and randomly assigned to either the intervention group or a six-month waitlist control group .\
METHODS	Inclusion criteria include an elevated stress level ( Cohen 's Perceived Stress Scale-10 22 ) and current employment .\
METHODS	Exclusion criteria include risk of suicide or previously diagnosed psychosis or dissociative symptoms .\
METHODS	The primary outcome will be perceived stress , and secondary outcomes include depression and anxiety .\
METHODS	Data will be collected at baseline and seven weeks and six months after randomization .\
METHODS	An extended follow up at 12 months is planned for the intervention group .\
METHODS	Moreover , a cost-effectiveness analysis will be conducted from a societal perspective and will include both direct and indirect health care costs .\
METHODS	Data will be analyzed on an intention-to-treat basis and per protocol .\
CONCLUSIONS	The substantial negative consequences of work-related stress emphasize the necessity for effective stress-management trainings .\
CONCLUSIONS	If the proposed internet intervention proves to be ( cost - ) effective , a preventative , economical stress-management tool will be conceivable .\
CONCLUSIONS	The strengths and limitations of the present study are discussed .\
BACKGROUND	German Register of Clinical Studies ( DRKS ) : DRKS00004749 .\
\
###25151398\
BACKGROUND	The aging process involves a decline in immune functioning that renders elderly people more vulnerable to disease .\
BACKGROUND	In residential programs for the aged , it is vital to diminish their risk of disease , promote their independence , and augment their psychological well-being and quality of life .\
METHODS	We performed a randomized controlled study , evaluating the ability of a relaxation technique based on Benson 's relaxation response to enhance psychological well-being and modulate the immune parameters of elderly people living in a geriatric residence when compared to a waitlist control group .\
METHODS	The study included a 2-week intervention period and a 3-month follow-up period .\
METHODS	The main outcome variables were psychological well-being and quality of life , biomedical variables , immune changes from the pre-treatment to post-treatment and follow-up periods .\
RESULTS	Our findings reveal significant differences between the experimental and control groups in CD19 , CD71 , CD97 , CD134 , and CD137 lymphocyte subpopulations at the end of treatment .\
RESULTS	Furthermore , there was a decrease in negative affect , psychological discomfort , and symptom perception in the treatment group , which increased participants ' quality of life scores at the three-month follow-up .\
CONCLUSIONS	This study represents a first approach to the application of a passive relaxation technique in residential programs for the elderly .\
CONCLUSIONS	The method appears to be effective in enhancing psychological well-being and modulating immune activity in a group of elderly people .\
CONCLUSIONS	This relaxation technique could be considered an option for achieving health benefits with a low cost for residential programs , but further studies using this technique in larger samples of older people are needed to confirm the trends observed in the present study .\
BACKGROUND	International Standard Randomised Controlled Trial Number Register ISRCTN85410212 .\
\
###23407696\
OBJECTIVE	In cardiac surgery , the choice of temperature regimen during cardiopulmonary bypass ( CPB ) remains a subject of debate .\
OBJECTIVE	Hypothermia reduces tissue metabolic demands , but may impair the autoregulation of cerebral blood flow and contribute to neurological morbidity .\
OBJECTIVE	The aim of this study was to evaluate the effect of two different temperature regimens during CPB on the systemic oxygen transport and the cerebral oxygenation during surgical correction of acquired heart diseases .\
METHODS	In a prospective study , we randomized 40 adult patients with combined valvular disorders requiring surgical correction of two or more valves into two groups : ( i ) a normothermic ( NMTH ) group ( n = 20 ) , in which the body core temperature was maintained at 36.6 C during CPB and ( ii ) a hypothermic ( HPTH ) group ( n = 20 ) , in which the body was cooled to a core temperature of 32C maintained throughout the period of CPB .\
METHODS	The systemic oxygen transport and the cerebral oxygen saturation ( SctO2 ) were assessed by means of a PiCCO2 haemodynamic monitor and a cerebral oximeter , respectively .\
METHODS	All the patients received standard perioperative monitoring .\
METHODS	We assessed haemodynamic and oxygen transport parameters , the duration of mechanical ventilation and the length of the ICU and the hospital stays .\
RESULTS	During CPB , central venous oxygen saturation was significantly higher in the HPTH group but SctO2 was increased in the NMTH group ( P < 0.05 ) .\
RESULTS	Cardiac index , systemic oxygen delivery and consumption increased postoperatively in both groups .\
RESULTS	However , oxygen delivery and consumption were significantly higher in the NMTH group ( P < 0.05 ) .\
RESULTS	The duration of respiratory support and the length of ICU and hospital stays did not differ between the groups .\
CONCLUSIONS	During combined valve surgery , normothermic CPB provides lower central venous oxygen saturation , but increases cerebral tissue oxygenation when compared with the hypothermic regimen .\
\
###17684877\
OBJECTIVE	The aim of this study is to compare the efficiency of low dose vs. varying doses of hyperbaric bupivacaine in spinal anesthesia for endoscopic urological procedures .\
METHODS	Sixty consecutive patients were studied in a randomized prospective manner .\
METHODS	They received either of 5 ( Gr I ) , 7.5 ( Gr II ) or 10 mg ( Gr III ) of hyperbaric bupivacaine 0.5 % combined with 25 microg of fentanyl , through a 25-gauge W hitacre spinal needle placed in the L3-L4 interspace .\
METHODS	Characteristics of sensory and motor block , dose of ephedrine required , secondary effects , the patients , and the surgeons satisfaction , were noted .\
RESULTS	The maximum number of blocked segments was 14 + / - 1 ( Gr I ) , 15 + / - 2 ( Gr II ) and 16 + / - 2 ( Gr III ) .\
RESULTS	Time to T12 regression was significantly shorter for Gr I ( 53 + / - 13 min ) than for Gr II ( 69 + / - 20 min ) or Gr III ( 94 + / - 14 min ) .\
RESULTS	Bromage 3 block was not found in Gr I compared to 4 patients in Gr II and 15 patients in Gr III .\
RESULTS	The duration of motor block was shorter in Gr 1 ( 51 + / - 18 min ) than in Gr II ( 86 + / - 19 min ) and in Gr III ( 138 + / - 21 min ) .\
RESULTS	Ephedrine was used for 16 patients in Gr III ( 9.8 + / - 12.2 mg ) , 5 patients in Gr II ( 3.7 + / - 7.8 mg ) and 2 patients in Gr I ( 0.5 + / - 1.5 mg ) .\
RESULTS	The difference is statistically significant between Gr III and the other groups .\
CONCLUSIONS	These results suggest that the use of a low dose of bupivacaine ( 5 mg ) added to fentanyl ( 25 microg ) for endoscopic urological surgery , resulted in short-acting sensory block , without motor block and a lower incidence of cardiovascular side effects , as compared to either of 7.5 or 10 mg bupivacaine with 25 microg fentanyl .\
\
###18265875\
BACKGROUND	Helminth infection is common in malaria endemic areas , and an interaction between the two would be of considerable public health importance .\
BACKGROUND	Animal models suggest that helminth infections may increase susceptibility to malaria , but epidemiological data has been limited and contradictory .\
RESULTS	In a vaccine trial , we studied 387 one - to six-year-old children for the effect of helminth infections on febrile Plasmodium falciparum malaria episodes .\
RESULTS	Gastrointestinal helminth infection and eosinophilia were prevalent ( 25 % and 50 % respectively ) , but did not influence susceptibility to malaria .\
RESULTS	Hazard ratios were 1 for gastrointestinal helminth infection ( 95 % CI 0.6-1 .6 ) and 0.85 and 0.85 for mild and marked eosinophilia , respectively ( 95 % CI 0.56-1 .76 and 0.69-1 .96 ) .\
RESULTS	Incident rate ratios for multiple episodes were 0.83 for gastro-intestinal helminth infection ( 95 % CI 0.5-1 .33 ) and 0.86 and 0.98 for mild and marked eosinophilia ( 95 % CI 0.5-1 .4 and 0.6-1 .5 ) .\
CONCLUSIONS	There was no evidence that infection with gastrointestinal helminths or urinary schistosomiasis increased susceptibility to Plasmodium falciparum malaria in this study .\
CONCLUSIONS	Larger studies including populations with a greater prevalence of helminth infection should be undertaken .\
\
###24257718\
BACKGROUND	Epidemiologic and experimental data have suggested that chlorogenic acid , which is a polyphenol contained in green coffee beans , prevents diet-induced hepatic steatosis and insulin resistance .\
OBJECTIVE	We assessed whether the consumption of chlorogenic acid-rich coffee attenuates the effects of short-term fructose overfeeding , dietary conditions known to increase intrahepatocellular lipids ( IHCLs ) , and blood triglyceride concentrations and to decrease hepatic insulin sensitivity in healthy humans .\
METHODS	Effects of 3 different coffees were assessed in 10 healthy volunteers in a randomized , controlled , crossover trial .\
METHODS	IHCLs , hepatic glucose production ( HGP ) ( by 6,6-d2 glucose dilution ) , and fasting lipid oxidation were measured after 14 d of consumption of caffeinated coffee high in chlorogenic acid ( C-HCA ) , decaffeinated coffee high in chlorogenic acid , or decaffeinated coffee with regular amounts of chlorogenic acid ( D-RCA ) ; during the last 6 d of the study , the weight-maintenance diet of subjects was supplemented with 4 g fructose kg ( -1 ) d ( -1 ) ( total energy intake SD : 143 1 % of weight-maintenance requirements ) .\
METHODS	All participants were also studied without coffee supplementation , either with 4 g fructose kg ( -1 ) d ( -1 ) ( high fructose only ) or without high fructose ( control ) .\
RESULTS	Compared with the control diet , the high-fructose diet significantly increased IHCLs by 102 36 % and HGP by 16 3 % and decreased fasting lipid oxidation by 100 29 % ( all P < 0.05 ) .\
RESULTS	All 3 coffees significantly decreased HGP .\
RESULTS	Fasting lipid oxidation increased with C-HCA and D-RCA ( P < 0.05 ) .\
RESULTS	None of the 3 coffees significantly altered IHCLs .\
CONCLUSIONS	Coffee consumption attenuates hepatic insulin resistance but not the increase of IHCLs induced by fructose overfeeding .\
CONCLUSIONS	This effect does not appear to be mediated by differences in the caffeine or chlorogenic acid content .\
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00827450 .\
\
###21749850\
OBJECTIVE	Several studies have indicated that water infusion , instead of air insufflation , enhances cecal intubation in selected patients undergoing unsedated colonoscopy .\
OBJECTIVE	We performed a prospective , randomized , controlled trial to investigate whether the water technique increases the proportion of patients that are able to complete unsedated colonoscopy .\
METHODS	We analyzed data from 116 consecutive outpatients who were willing to start colonoscopy without sedation ; 58 were each randomly assigned to groups given water infusion or air insufflation during the insertion phase .\
METHODS	Sedation and analgesia were administered on demand .\
RESULTS	Fewer patients requested sedation in the water group ( 8.6 % ) than in the air group ( 34.5 % ; P = .003 ) and their maximum pain scores were lower ( 2.8 1.9 vs 4.2 2.3 in the air group ; P = .011 ) .\
RESULTS	However , differences in percentages of patients who received complete , unsedated colonoscopy between the water group ( 74.1 % ) and air group ( 62.1 % ) did not reach statistical significance ( P = .23 ) ; the percentage of successful cecal intubations was lower in the water group ( 82.8 % ) than in the air group ( 96.5 % ; P = .03 ) because of poor visibility .\
RESULTS	Failed procedures in the water group were completed successfully after air insufflation .\
RESULTS	The cecal intubation time was shorter in the air group ( 6.2 3.4 min ) than in the water group ( 8.1 3.0 min ; P = .01 ) .\
CONCLUSIONS	In patients willing to undergo unsedated colonoscopy , water infusion improves patient tolerance for cecal intubation , compared with air insufflation .\
CONCLUSIONS	However , it does not increase the overall percentage of successful cecal intubations because suboptimal bowel preparation interferes with visibility .\
\
###12700623\
OBJECTIVE	To ascertain whether simple dietary advice to increase the consumption of Mediterranean foods , given in a clinical setting , leads to reduced mortality after a myocardial infarction .\
METHODS	Data were used from the GISSI-Prevenzione clinical trial , analysed as a cohort study with adjustment for treatment allocation .\
METHODS	A total of 172 centres in Italy .\
METHODS	A total of 11323 men and women with myocardial infarction .\
METHODS	All subjects received advice to increase their consumption of fish , fruit , raw and cooked vegetables and olive oil .\
METHODS	The intakes of the five foods were assessed at baseline , 6 , 18 and 42 months .\
METHODS	Associations of food intakes , a combined dietary score , and the risk of death over 6.5 y were estimated adjusting for several non-dietary variables , using pooled logistic regression .\
RESULTS	Subjects generally improved their diet according to the advice given .\
RESULTS	All foods were associated with a significant reduction in risk of death .\
RESULTS	Compared with people in the worst dietary score quarter , the odds ratio for those in the best score quarter was 0.51 ( 95 % CI 0.44-0 .59 ) .\
RESULTS	A good diet had a protective effect in sub-groups defined by age , sex , smoking , randomized treatment and concomitant drug therapy .\
CONCLUSIONS	Myocardial infarction patients can respond positively to simple dietary advice , and this can be expected to lead to a substantial reduction in the risk of early death .\
CONCLUSIONS	Regardless of any drug treatment prescribed , clinicians should routinely advise patients with myocardial infarction to increase their frequency of consumption of Mediterranean foods .\
\
###22256633\
OBJECTIVE	To observe the efficacy of moxibustion on the improvement in pain , stiffness and motor disturbance for the patients with knee osteoarthritis ( OA ) and evaluate the effectiveness and safety of moxibustion therapy .\
METHODS	Fifty-nine cases of knee OA were randomly divided into a moxibustion group ( 31 cases ) and a placebo moxibustion group ( 28 cases ) , in which moxa cone and placebo moxa sticker were applied to Neixiyan ( EX-LE 4 ) , Dubi ( ST 35 ) and Ashi points separately , 3 cones on each point in each treatment .\
METHODS	The treatment was given once every two days , 3 times per week , continuously for 6 weeks .\
METHODS	The follow-up visit was performed in 6 weeks after the end of treatment .\
METHODS	The Western Ontario and Mcmaster Universities Osteoarthritis Index ( WOMAC ) and the time of 46-meter walking at the fastest speed were adopted to evaluate the recovery of joint function .\
METHODS	UT-325 digital thermal detector was used to record the temperature change at the most apparent pain points of knee joint before and after moxibustion treatment .\
RESULTS	In moxibustion group , the scores in WOMAC were reduced apparently in 3 and 6 weeks treatment and during follow-up visit , separately ( P < 0.05 , P < 0.01 , P < 0.001 ) .\
RESULTS	In placebo moxibustion group , during follow-up visit , the score of stiffness was lower as compared with that before treatment ( P < 0.05 ) .\
RESULTS	In 6 weeks of treatment and during follow-up visit , the scores of pain , stiffness and motor disturbance in moxibustion group were reduced much more remarkably as compared with placebo moxibustion group ( P < 0.01 , P < 0.05 ) .\
RESULTS	In moxibustion group , after treatment for 6 weeks , the time of 46-meter walking at the fastest speed was shorter apparently as compared with that before treatment ( P < 0.01 ) , but there was no apparent improvement after treatment in placebo moxibustion group ( P > 0.05 ) .\
RESULTS	The difference was not significant statistically in group comparison ( P > 0.05 ) .\
RESULTS	After moxibustion , the temperature at treatment point was ( 49.81 + / - 3.10 ) degrees C in moxibustion group and was ( 40.98 + / - 1.67 ) degrees C in placebo moxibustion group .\
RESULTS	The local skin temperature increased apparently as compared with that before treatment in either group ( P < 0.001 , P < 0.01 ) , but the temperature increasing in moxibustion group was much more remarkable ( P < 0.001 ) .\
CONCLUSIONS	Moxibustion can obviously improve in the clinical symptoms for the patients with knee osteoarthritis , such as pain , stiffness and motor disturbance .\
CONCLUSIONS	It is a safe and effective therapy .\
\
###25116230\
BACKGROUND	Some of the health advantages of breast-fed as compared to formula-fed infants have been suggested to be due to metabolic programming effects resulting from early nutrition .\
METHODS	In a prospective double-blinded randomized trial , 160 infants < 2 mo of age were randomized to experimental formula ( EF ) with added milk fat globule membrane ( MFGM ) or standard formula ( SF ) until 6 mo of age .\
METHODS	A breast-fed reference ( BFR ) group consisted of 80 infants .\
METHODS	Measurements were made at inclusion and at 4 , 6 , and 12 mo of age .\
RESULTS	During the intervention , the EF group had higher total serum cholesterol concentration than the SF group , reaching the level of the BFR group .\
RESULTS	The EF group had a low-density lipoprotein to high-density lipoprotein ratio not significantly different from the SF group but lower than the BFR group .\
CONCLUSIONS	Supplementation of infant formula with MFGM modified the fat composition of the formula and narrowed the gap between breast-fed and formula-fed infants with regard to serum lipid status at 12 mo. .\
\
###21093107\
BACKGROUND	Informed consent is a phrase often used in the law to indicate that the consent a person gives meets certain minimum standards .\
BACKGROUND	It relies on patients ' ability to understand risk information .\
BACKGROUND	Evidence suggests that people may extract the gist of any risk information to make medical decisions .\
BACKGROUND	Existing evidence also suggests that there is an inverse relationship between the perception of risk and the perception of benefit .\
BACKGROUND	Informed consent is the method by which fully informed , rational persons may be involved in choices about their health care .\
OBJECTIVE	The aims of this study were to study how much patients remember of the risks discussed with them about their otolaryngologic surgery and to evaluate whether a simple intervention , the addition of an information handout , improves their recall .\
METHODS	This was a prospective study carried out between January and December 2009 in the Department of Otorhinolaryngology , University of Ilorin teaching hospital .\
METHODS	Fifty patients undergoing a variety of otorhinolaryngologic procedures , including mastoidectomy , tympanoplasty , nasal polypectomy , rhinotomy , maxillectomy , and laryngoscopy , were verbally consented by the operating surgeon with a standard checklist of potential surgical complications and adverse effects .\
METHODS	Three surgeons participated in the study .\
METHODS	Patients were stratified into 2 groups : a higher education group and a lower education group .\
METHODS	Within each group , patients were randomized to either a control group , consisting of a verbal explanation only , or an intervention group , which added a written handout to the verbal explanation .\
METHODS	A follow-up telephone interview was conducted at an average of 20.6 days ( range , 14-53 days ) to survey for recall of the complications discussed .\
METHODS	The main outcome measure is risk recall .\
METHODS	This was analyzed by education level and written sheet intervention .\
METHODS	Other parameters examined were patient demographics and time elapsed from when the consent was obtained .\
RESULTS	Of the 50 patients involved in the study , 30 were men and 20 were women , with male/female ratio of 1.5:1.0 .\
RESULTS	The average age was 43 years ( range , 16-76 years ) .\
RESULTS	With respect to educational status , 26 patients had the equivalent of high school or less ( group 1 ) , and 24 had some degree of postsecondary training ( group 2 ) .\
RESULTS	Overall recall of potential complications was 56 % .\
RESULTS	Those who received the handout recalled 67 % of the complications overall , whereas those who did not receive the handout remembered 51 % of the complications .\
RESULTS	The difference was significant recall of the specific risks varied considerably .\
RESULTS	For those with potential risk of facial nerve paralysis , 88 % of them recalled , which was the highest in the study .\
RESULTS	This was followed by hearing loss ( 85 % ) and nasal adhesion ( 23 % ) .\
RESULTS	The least were anesthetic reactions ( 4 % ) and hoarseness ( 2 % ) .\
RESULTS	Those who received the handout recalled 62 % of the complications overall , whereas those who did not receive the handout remembered 51 % the complications .\
CONCLUSIONS	The addition of a handout significantly alters recall of potential complications of otorhinolaryngologic surgery with the recall of specific risk highest for facial nerve paralysis .\
\
###9613374\
OBJECTIVE	Two viable options were compared , reoperation and botulinum toxin injection , in the management of children who need retreatment after surgery for acquired esotropia .\
METHODS	47 strabismic children previously operated to correct an acquired esotropia were randomised to reoperation or botulinum toxin injection .\
METHODS	Reoperation was undertaken in 24 of these patients and botulinum toxin injection in 23 of them .\
METHODS	The percentage net change in distance deviation , the percentage of patients with successful motor outcome , detectable fusion , and stereopsis were compared 1 year after retreatment and at last visit ( average follow up : 2.9 years in reoperation group , and 2.7 years in botulinum group ) .\
METHODS	The motor success rate relative to time elapsed from initial surgery was evaluated .\
RESULTS	There was no significant difference in the motor and sensory outcomes between patients reoperated and treated with botulinum injection .\
RESULTS	The frequency of correction to within 8 prism dioptres of orthotropia was , respectively : 75 % versus 69.56 % at 1 year ; 70.83 % versus 60.86 % at last visit .\
RESULTS	Botulinum injection could be more effective when performed within 3 months of initial surgery .\
CONCLUSIONS	Botulinum injection is a rapid and safe procedure that may be as effective as reoperation in the management of children who need a secondary procedure after surgery for acquired esotropia .\
\
###22115657\
OBJECTIVE	The aim of this study was to study whether there is a difference in benefit of fractional flow reserve ( FFR ) guidance for percutaneous coronary intervention ( PCI ) in multivessel coronary disease in patients with unstable angina ( UA ) or non-ST-segment elevation myocardial infarction ( NSTEMI ) , compared with stable angina ( SA ) .\
BACKGROUND	The use of FFR to guide PCI has been well established for patients with SA .\
BACKGROUND	Its use in patients with UA or NSTEMI has not been investigated prospectively .\
METHODS	In the FAME ( Fractional flow reserve versus Angiography for Multivessel Evaluation ) study 1,005 patients with multivessel disease amenable to PCI were included and randomized to either angiography-guided PCI of all lesions 50 % or FFR-guided PCI of lesions with an FFR 0.80 .\
METHODS	Patients admitted for UA or NSTEMI with positive troponin but total creatine kinase < 1,000 U/l were eligible for inclusion .\
METHODS	We determined 2-year major adverse cardiac event rates of these patients and compared it with stable patients .\
RESULTS	Of 1,005 patients , 328 had UA or NSTEMI .\
RESULTS	There was no evidence for heterogeneity among the subgroups for any of the outcome variables ( all p values > 0.05 ) .\
RESULTS	Using FFR to guide PCI resulted in similar risk reductions of major adverse cardiac events and its components in patients with UA or NSTEMI , compared with patients with SA ( absolute risk reduction of 5.1 % vs. 3.7 % , respectively , p = 0.92 ) .\
RESULTS	In patients with UA or NSTEMI , the number of stents was reduced without increase in hospital stay or procedure time and with less contrast use , in similarity to stable patients .\
CONCLUSIONS	The benefit of using FFR to guide PCI in multivessel disease does not differ between patients with UA or NSTEMI , compared with patients with SA .\
\
###8192751\
OBJECTIVE	To evaluate the correlation between the presence and titer of host-derived antibody reactivity , circulating immune complexes , and clinical course and prognosis in patients with squamous cell carcinoma of the head and neck ( SCCHN ) .\
METHODS	Serum samples , obtained from untreated patients with squamous cell carcinoma of the larynx entered onto a multiinstitutional trial , were evaluated for the presence of elevated circulating immune complexes ( 221 patients ) and host-derived antibody directed against two SCCHN cell lines ( 107 patients ) .\
RESULTS	Patients had significantly elevated levels of circulating immune complexes as measured by C1q binding compared with normal controls .\
RESULTS	Patients with higher levels of circulating immune complexes were less likely to respond to chemotherapy .\
RESULTS	No correlations were noted between immune complex levels and stage of disease , nodal status , site of disease , recurrence , or survival .\
RESULTS	Evaluation of native antibody titers for their relationship to clinical correlates showed no statistically significant associations .\
RESULTS	In sera subjected to immune complex dissociation , patients with moderately or poorly differentiated tumors had significantly higher antibody titers when compared with patients with well-differentiated tumors .\
RESULTS	Because marked variation in the increase of antibody titers following immune complex dissociation was noted , the ratio of immune complex-dissociated to native antibody titer was examined .\
RESULTS	Patients with a high ratio had a lower proportion of complete and partial responses to chemotherapy .\
CONCLUSIONS	Our results support the conclusion that the formation of tumor-associated immune complexes in patients with SCCHN is associated with a decreased response to chemotherapy .\
\
###23811112\
OBJECTIVE	The combination of a hepatitis C virus ( HCV ) protease inhibitor , peginterferon , and ribavirin is the standard of care for patients with HCV genotype 1 infection .\
OBJECTIVE	We report the efficacy and safety of response-guided therapy with danoprevir ( a potent second-generation protease inhibitor ) , peginterferon alfa-2a ( 40 KD ) , and ribavirin in these patients .\
METHODS	Treatment-nave patients ( N = 237 ) were randomly assigned to groups given 12 weeks of danoprevir ( 300 mg every 8 hours ; 600 mg every 12 hours , and 900 mg every 12 hours ) or placebo plus peginterferon alfa-2a and ribavirin , followed by peginterferon alfa-2a and ribavirin .\
METHODS	Patients given danoprevir who had an extended rapid virologic response ( eRVR4-20 : HCV RNA < 15 IU/mL during weeks 4-20 ) stopped therapy at week 24 ; those without an eRVR4-20 continued therapy to 48 weeks .\
METHODS	Patients who were given placebo received 48 weeks of peginterferon alfa-2a and ribavirin .\
METHODS	The primary efficacy end point was sustained virologic response ( SVR : HCV RNA < 15 IU/mL after 24 weeks without treatment ) .\
RESULTS	Rates of SVR were higher among patients given danoprevir 300 mg ( 68 % ) , 600 mg ( 85 % ) , and 900 mg ( 76 % ) than placebo ( 42 % ) ( 95 % confidence interval : 26 % -59 % ) .\
RESULTS	Seventy-nine percent of patients given danoprevir 600 mg had an eRVR4-20 ; among these , 96 % had an SVR .\
RESULTS	Serious adverse events were reported in 7 % to 8 % of patients given danoprevir and 19 % given placebo .\
RESULTS	Four patients given danoprevir ( 1 patient in the 600-mg group and 3 in the 900-mg group ) had reversible , grade 4 increases in alanine aminotransferase , which led to early discontinuation of the 900-mg arm of the study .\
CONCLUSIONS	The combination of danoprevir , peginterferon alfa-2a , and ribavirin leads to high rates of SVR in patients with HCV genotype 1 infection , but high doses of danoprevir can lead to grade 4 increases in alanine aminotransferase .\
CONCLUSIONS	Studies of lower doses of danoprevir with ritonavir , to reduce overall danoprevir exposure while maintaining potent antiviral activity , are underway ; Clinicaltrials.gov number , NCT00963885 .\
\
###22928579\
OBJECTIVE	Active recruitment of smokers increases the reach of quitlines ; however , some quitlines restrict proactive telephone counselling ( i.e. counsellor-initiated calls ) to smokers ready to quit within 30 days .\
OBJECTIVE	Identifying characteristics associated with successful quitting by actively recruited smokers could help to distinguish those most likely to benefit from proactive telephone counselling .\
OBJECTIVE	This study assessed the baseline characteristics of actively recruited smokers associated with prolonged abstinence at 4 , 7 and 13 months and the proportion achieving prolonged abstinence that would miss out on proactive telephone counselling if such support was offered only to smokers intending to quit within 30 days at baseline .\
METHODS	Secondary analysis of a randomized controlled trial in which the baseline characteristics associated with prolonged abstinence were examined .\
METHODS	New South Wales ( NSW ) community , Australia .\
METHODS	A total of 1562 smokers recruited at random from the electronic NSW telephone directory .\
METHODS	Baseline socio-demographic and smoking-related characteristics associated with prolonged abstinence at 4 , 7 and 13 months post-recruitment .\
RESULTS	Waiting more than an hour to smoke after waking and intention to quit within 30 days at baseline predicted five of the six prolonged abstinence measures .\
RESULTS	If proactive telephone counselling was restricted to smokers who at baseline intended to quit within 30 days , 53.8-65 .9 % of experimental group participants who achieved prolonged abstinence would miss out on telephone support .\
CONCLUSIONS	Less addicted and more motivated smokers who are actively recruited to quitline support are more likely to achieve abstinence .\
CONCLUSIONS	Most actively recruited smokers reported no intention to quit within the next 30 days , but such smokers still achieved long-term abstinence .\
\
###25657106\
OBJECTIVE	To evaluate the clinical efficacy of an established programme of occupational therapy in maintaining functional activity and reducing further health risks from inactivity in care home residents living with stroke sequelae .\
METHODS	Pragmatic , parallel group , cluster randomised controlled trial .\
METHODS	228 care homes ( > 10 beds each ) , both with and without the provision of nursing care , local to 11 trial administrative centres across the United Kingdom .\
METHODS	1042 care home residents with a history of stroke or transient ischaemic attack , including those with language and cognitive impairments , not receiving end of life care .\
METHODS	114 homes ( n = 568 residents , 64 % from homes providing nursing care ) were allocated to the intervention arm and 114 homes ( n = 474 residents , 65 % from homes providing nursing care ) to standard care ( control arm ) .\
METHODS	Participating care homes were randomised between May 2010 and March 2012 .\
METHODS	Targeted three month programme of occupational therapy , delivered by qualified occupational therapists and assistants , involving patient centred goal setting , education of care home staff , and adaptations to the environment .\
METHODS	Primary outcome at the participant level : scores on the Barthel index of activities of daily living at three months post-randomisation .\
METHODS	Secondary outcome measures at the participant level : Barthel index scores at six and 12 months post-randomisation , and scores on the Rivermead mobility index , geriatric depression scale-15 , and EuroQol EQ-5D-3L questionnaire , at all time points .\
RESULTS	64 % of the participants were women and 93 % were white , with a mean age of 82.9 years .\
RESULTS	Baseline characteristics were similar between groups for all measures , personal characteristics , and diagnostic tests .\
RESULTS	Overall , 2538 occupational therapy visits were made to 498 participants in the intervention arm ( mean 5.1 visits per participant ) .\
RESULTS	No adverse events attributable to the intervention were recorded .\
RESULTS	162 ( 11 % ) died before the primary outcome time point , and 313 ( 30 % ) died over the 12 months of the trial .\
RESULTS	The primary outcome measure did not differ significantly between the treatment arms .\
RESULTS	The adjusted mean difference in Barthel index score at three months was 0.19 points higher in the intervention arm ( 95 % confidence interval -0.33 to 0.70 , P = 0.48 ) .\
RESULTS	Secondary outcome measures also showed no significant differences at all time points .\
CONCLUSIONS	This large phase III study provided no evidence of benefit for the provision of a routine occupational therapy service , including staff training , for care home residents living with stroke related disabilities .\
CONCLUSIONS	The established three month individualised course of occupational therapy targeting stroke related disabilities did not have an impact on measures of functional activity , mobility , mood , or health related quality of life , at all observational time points .\
CONCLUSIONS	Providing and targeting ameliorative care in this clinically complex population requires alternative strategies.Trial registration Current Controlled Trials ISRCTN00757750 .\
\
###11318080\
BACKGROUND	Use of cholesterol-lowering regimens has been shown to reduce the risk of coronary heart disease ( CHD ) , both in primary and secondary prevention .\
BACKGROUND	However , there have been few studies of the relative benefits and risks of the various cholesterol-lowering agents in patient groups with specific risk factors for CHD .\
OBJECTIVE	The primary goal of this study was to compare the proportions of adult patients with primary hypercholesterolemia and a moderate to high risk for CHD achieving National Cholesterol Education Program low-density lipoprotein cholesterol ( LDL-C ) goals with titrate-to-goal regimens of simvastatin and fluvastatin .\
METHODS	This was a multicenter , prospective , randomized , double-blind , parallel-group study enrolling adult patients with type IIa or IIb primary hypercholesterolemia , LDL-C levels < 6.0 mmol/L ( < 232.0 mg/dL ) , and triglyceride levels < 4.5 mmol/L ( < 398.6 mg/dL ) , and either CHD or other atherosclerotic disease ( the CHD , or high-risk , group ) , or multiple risk factors for CHD ( the MRF , or moderate-risk , group ) .\
METHODS	After a 6-week washout period , patients were randomized to 18 weeks of treatment at an initial dosage of simvastatin 10 mg once daily or fluvastatin 20 mg once daily .\
METHODS	At 6 - and 12-week titration visits , the dosage in patients who had not acheived the LDL-C goal could be increased to simvastatin 20 mg once daily and then 40 mg once daily , or to fluvastatin 40 mg once daily and then 40 mg twice daily .\
METHODS	Lipid profiles were obtained at each titration visit and at the end of treatment .\
METHODS	In addition to the comparison between treatments , secondary comparisons were made between the CHD and MRF subgroups within each treatment group .\
METHODS	Statistical significance was assessed using analysis of variance .\
RESULTS	A total of 478 patients were enrolled , 237 in the simvastatin group and 241 in the fluvastatin group .\
RESULTS	There were no significant between-group differences in patients ' characteristics at baseline .\
RESULTS	At the end of the study , 60.8 % ( 135/222 ) of patients in the simvastatin group had reached target LDL-C goals , compared with 35.1 % ( 76/216 ) in the fluvastatin group ( P < 0.001 ) .\
RESULTS	In the simvastatin CHD and MRF subgroups , 49 % and 73 % , respectively , reached the LDL-C target , compared with 19 % and 50 % in the corresponding fluvastatin subgroups ( P < 0.001 ) .\
RESULTS	The proportion of patients requiring titration was higher in the fluvastatin group than in the simvastatin group ( 87.1 % and 64.1 % , respectively ; P = 0.001 ) .\
RESULTS	The incidence of adverse events was similar between groups .\
CONCLUSIONS	In this study , more patients with primary hypercholesterolemia and CHD or multiple risk factors for CHD reached LDL-C goals with simvastatin treatment and required less titration than those who received fluvastatin treatment .\
\
###10405745\
OBJECTIVE	To assess the effects of the intravenous injection rate and dose of contrast material on pancreatic computed tomography ( CT ) .\
METHODS	A total of 126 patients were divided at random into four groups with different injection rates and doses .\
METHODS	Groups 1 and 2 underwent injection of 2 mL per kilogram of body weight of 300 mg of iodine per milliliter of contrast material , and groups 3 and 4 underwent injection of 1.5 mL/kg .\
METHODS	The injection rate was 5 mL/sec for groups 1 and 3 and 3 mL/sec for groups 2 and 4 .\
METHODS	Single-level serial CT scanning was performed at the level of the pancreatic head , and the pancreatic enhancement value was calculated .\
RESULTS	The maximum pancreatic enhancement value was 99 HU + / - 18 ( mean + / - SD ) for group 1 , 90 HU + / - 18 for group 2 , 86 HU + / - 15 for group 3 , and 74 HU + / - 13 for group 4 .\
RESULTS	There were significant differences in the maximum pancreatic enhancement value between groups 1 and 2 ( P = .045 ) , between groups 3 and 4 ( P = .001 ) , between groups 1 and 3 ( P = .016 ) , and between groups 2 and 4 ( P = .001 ) .\
CONCLUSIONS	Both a higher dose and a faster injection rate increased the maximum pancreatic enhancement value .\
\
###23989971\
OBJECTIVE	To assess the efficacy and safety of a new method of clearing varicose veins in the long term .\
OBJECTIVE	It consists of applying the long-pulsed Nd : YAG laser following the injection of polidocanol microfoam , in two consecutive sessions , treating both legs in full in each session .\
METHODS	Randomized , Polidocanol-controlled , blind evaluation clinical trial comparing the results between 79 legs treated with Polidocanol and 517 treated with Polidocanol + Laser .\
METHODS	Photographs were taken preoperatively and at three months , two years and three years after treatment , as well as patient self-assessments .\
RESULTS	Polidocanol + Laser is much more effective than polidocanol microfoam in clearing venulectasias with a diameter under 4mm ( p < 0.001 ) .\
RESULTS	After three years , clearing percentages of 89 % ( Class I veins ) , 94 % ( Class II veins ) and 95 % ( Class III veins ) are observed , in comparison to 15 % , 18 % and 17 % , respectively when only polidocanol was applied .\
RESULTS	No unexpected adverse effects were found and 86 % of patients stated they were Satisfied or Very Satisfied .\
CONCLUSIONS	The method leads to safe , fast and apparently permanent results .\
CONCLUSIONS	The treatment session lasts less than 1h , and could become a first-choice treatment for the removal of all types of varicose veins with a diameter under 4mm .\
\
###10532976\
OBJECTIVE	To compare the efficacy and safety of hybrid laser treatment , i.e. the combination of visual Nd-YAG laser ablation of prostate and contact Nd-YAG laser vaporization of prostate , with transurethral resection of the prostate ( TURP ) in the treatment of patients with symptomatic bladder outlet obstruction secondary to a benign high-volume prostate .\
METHODS	Forty-five symptomatic patients with hyperplastic prostates of > 40 mL were randomized to undergo either hybrid laser treatment ( 21 ) or TURP ( 24 ) .\
METHODS	All patients were evaluated before and after treatment with a complex urodynamic assessment , and were accepted into the study only if they had infravesical obstruction in the pressure-flow study .\
METHODS	In the hybrid method , Nd-YAG laser energy was first delivered by an ` adenoma-dependent ' approach to all areas of the obstructing lateral lobe tissue through a side-firing gold-alloy tip fibre at 40 W for 90 s of ` burn ' .\
METHODS	The prostatic urethra was then opened and the median lobe vaporized using the a contact probe at 40 W. Patients were re-evaluated 3 and 6 months after treatment .\
RESULTS	Both treatments proved to be safe , and improved the subjective and objective outcome measures at 3 and 6 months compared with baseline values .\
RESULTS	After 3 months , there was a greater improvement in the TURP group in peak urinary flow rate ( Qmax ; P < 0.01 ) , mean urinary flow rate ( Qave ; P < 0.01 ) and postvoid residual urine volume ( P < 0.05 ) than in the hybrid laser group .\
RESULTS	After 6 months , there was a greater improvement in the TURP group in detrusor pressure at Qmax ( P < 0.01 ) , Qave ( P < 0.05 ) and prostate size ( P < 0.001 ) than in the hybrid laser group .\
RESULTS	In the pressure-flow study at 6 months , a higher proportion of patients ( seven of 19 ) were still obstructed in the hybrid laser group than in TURP group ( two of 21 ; P < 0.05 ) .\
RESULTS	TURP caused more intraoperative blood loss ( P < 0.001 ) and postoperative problems associated with bleeding ; 38 % of hybrid laser patients were discharged with a suprapubic catheter , whereas all TURP patients could urinate at discharge ( P < 0.01 ) .\
RESULTS	The duration of bladder drainage was longer after hybrid laser treatment ( P < 0.001 ) .\
CONCLUSIONS	The hybrid laser method was a safe but less effective treatment than TURP for benign prostatic enlargement in patients with prostates of > 40 mL .\
\
###24079283\
BACKGROUND	Niacin monotherapy in patients with dyslipidemia and impaired fasting glucose ( IFG ) may result in hyperglycemia .\
BACKGROUND	Colesevelam has the unique dual approvals to lower low-density lipoprotein cholesterol ( LDL-C ) and to improve glycemic control in type 2 diabetes mellitus .\
OBJECTIVE	The aim of our study was to evaluate the effect of combined colesevelam and niacin treatment on LDL-C-lowering and glycemic control in subjects with IFG and dyslipidemia .\
METHODS	Men or women 18 years of age , with dyslipidemia ( non-high-density lipoprotein cholesterol 100 mg/dL and 220 mg/dL ; high-density lipoprotein cholesterol < 60 mg/dL ) and fasting plasma glucose ( FPG ) 90 mg/dL and 145 mg/dL were randomly assigned 1:1 to colesevelam ( 3750 mg/d ) with niacin titration ( n = 70 ) or placebo with niacin titration ( n = 70 ) over 12 weeks .\
METHODS	Niacin was titrated from 500 mg/d up to a maximum of 2000 mg/d as tolerated , and all subjects took enteric-coated aspirin daily .\
METHODS	Lipid and glycemic efficacy parameters were assessed as well as safety evaluations of adverse events , vital signs , alanine aminotransferase , aspartate aminotransferase , hematology , and urinalysis .\
RESULTS	Adjunct colesevelam had significantly greater LDL-C-lowering effect than niacin alone ( placebo ) ; -20.67 % vs -12.86 % , respectively ( P = .0088 ) .\
RESULTS	Niacin-mediated increases in FPG were significantly less with adjunct colesevelam ( 1.8 mg/dL vs 6.7 mg/dL ; P = .0046 ) , and fewer colesevelam subjects had increases of 10 mg/dL in FPG ( 8 vs 17 , respectively ) .\
RESULTS	Adjunct colesevelam resulted in significantly smaller increases in hemoglobin A1c than placebo ( 0.06 % vs 0.18 % , respectively ; P = .005 ) .\
RESULTS	Consistent with hemoglobin A1c and FPG changes , fructosamine levels significantly decreased with colesevelam treatment ( -5.0 mol/L ) but increased with placebo ( 3.0 mol/L ; P = .0255 ) .\
CONCLUSIONS	Colesevelam as an adjunct to niacin therapy further lowers LDL-C while obviating the adverse effects of niacin on glucose metabolism in patients with dyslipidemia and IFG .\
\
###19708912\
BACKGROUND	Devices that monitor the depth of anesthesia are increasingly used to titrate sedation and avoid awareness during anesthesia .\
BACKGROUND	Many of these monitors are based upon electroencephalography ( EEG ) collected from large adult reference populations and not pediatric populations ( Anesthesiology , 86 , 1997 , 836 ; Journal of Anaesthesia , 92 , 2004 , 393 ; Anesthesiology , 99 , 2003 , 34 ) .\
BACKGROUND	We hypothesized that EEG patterns in children would be different from those previously reported in adults and that they would show anesthetic-specific characteristics .\
METHODS	This prospective observational study was approved by the Institutional Review Board , and informed written consent was obtained .\
METHODS	Patients were randomized to receive maintenance anesthesia with isoflurane or sevoflurane .\
METHODS	EEG data collection included at least 10 min at steady-state maintenance anesthesia .\
METHODS	The EEG was recorded continuously through emergence until after extubation .\
METHODS	A mixed model procedure was performed on global and regional power by pooled data analysis and by analyzing each anesthetic group separately .\
METHODS	Statistical significance was defined as P < 0.05 .\
RESULTS	Thirty-seven children completed the study ( ages 22 days-3 .6 years ) .\
RESULTS	Isoflurane and sevoflurane had different effects on global and regional EEG power during emergence from anesthesia , and frontal predominance patterns were significantly different between these two anesthetic agents .\
CONCLUSIONS	The principal finding of the present study was that there are anesthetic-specific and concentration-dependent EEG effects in children .\
CONCLUSIONS	Depth-of-anesthesia monitors that utilize algorithms based on the EEGs of adult reference populations therefore may not be appropriate for use in children .\
\
###21745113\
OBJECTIVE	To assess the impact on visual analog scale ( VAS ) pain scores of allowing male patients to view the procedure of flexible cystoscopy .\
METHODS	A total of 86 male patients admitted to our hospital for flexile cystoscopy by a single urologist between 2010 and 2011 were randomized to two equal groups .\
METHODS	Group 1 included 43 patients who were allowed to watch the video screen with the urologist .\
METHODS	Group 2 included 43 patients who were unable to view the video monitor .\
METHODS	All patients received the same real-time explanation during the cystoscopy .\
METHODS	Patients recorded their pain feeling on a VAS ranging from 0 to 10 after the physician completed the cystoscopy .\
METHODS	The pulse and respiratory rate were also recorded 5 minutes before the procedure and immediately after the procedure .\
RESULTS	There was no statistically significant difference in the postprocedure pulse rate and respiratory rate between groups .\
RESULTS	The mean pain score on the VAS in group 1 was statistically significantly lower than that in group 2 ( 1.120.96 vs 3.332.50 , P < 0.001 , Mann-Whitney U test ) .\
RESULTS	Patients who were allowed to watch the video screen experienced less discomfort at cystoscopy .\
CONCLUSIONS	Real-time visualization of flexible cystoscopy with simultaneous explanation improves male patients ' comfort .\
\
###17885543\
OBJECTIVE	We previously reported that nifedipine retard showed comparable efficacy to angiotensin-converting enzyme ( ACE ) inhibitors for the prevention of cardiac events in hypertensive patients with coronary artery disease during the Japan Multicenter Investigation for Cardiovascular Diseases B study .\
OBJECTIVE	In the nifedipine group , patients with a history of myocardial infarction ( MI ) showed a significant reduction in hospitalization for angina pectoris compared with the ACE inhibitor group .\
OBJECTIVE	We investigated whether this difference was related to the progression of coronary arteriosclerosis .\
METHODS	To evaluate coronary arteriosclerosis , we performed coronary angiography ( CAG ) and a quantitative analysis of coronary angiograms .\
RESULTS	The cumulative incidence of hospitalization for angina was significantly lower in the nifedipine group ( log-rank test P = 0.013 ) .\
RESULTS	The etiology of angina requiring hospitalization was determined on the basis of CAG findings .\
RESULTS	Its incidence secondary to the development of new lesions or the progression of existing lesions was significantly lower in the nifedipine group than in the ACE inhibitor group ( log-rank test P = 0.042 and P = 0.028 , respectively ) .\
RESULTS	Using quantitative coronary analysis , changes in the coronary artery luminal diameter were compared between the nifedipine and ACE inhibitor groups .\
RESULTS	The minimum coronary lumen diameter did not show a significant change in the nifedipine group , whereas it decreased significantly in the ACE inhibitor group ( paired t-test P = 0.002 ) , and there was a significant difference between the two groups by analysis of covariance ( P = 0.047 ) .\
CONCLUSIONS	These results indicate that nifedipine more effectively prevented admission for angina pectoris by inhibiting the progression of coronary artery disease in patients with a history of MI .\
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###23402500\
BACKGROUND	The authors conducted a prospective , randomized , single-blind study to determine the degree of pulpal anesthesia obtained with a primary infiltration of 1 cartridge of articaine in the incisive/mental nerve region of the mandibular second premolar and to determine the anesthetic efficacy of a repeat articaine infiltration 20 minutes after the primary infiltration .\
METHODS	One hundred asymptomatic adult subjects randomly received 2 sets of injections consisting of a primary mandibular second premolar infiltration of 1 cartridge of 4 % articaine with 1:100,000 epinephrine plus a repeat infiltration 20 minutes later ( using the same volume of articaine ) or a mock repeat infiltration in 2 separate appointments spaced at least 1 week apart .\
METHODS	The authors used an electric pulp tester to test the first molar , premolars , canine , and incisors for anesthesia in 4-minute cycles for 120 minutes .\
RESULTS	The success rates of the initial infiltrations for the first molar , canine , and incisor teeth ranged from 59 % to 19 % .\
RESULTS	The premolar success rates were moderately successful ( ie , 80 % -87 % ) , but anesthesia declined after 20-25 minutes .\
RESULTS	The repeat infiltration at 20 minutes significantly increased the success rate ( 92 % -94 % ) and the duration of pulpal anesthesia for the premolars .\
CONCLUSIONS	The initial infiltration was not effective in anesthetizing the first molar , canine , or incisor teeth and was only moderately successful in the premolars .\
CONCLUSIONS	Although the repeat infiltration significantly increased the success rate and duration in the premolars , the initial infiltration success rates were not high enough to support the use of this regimen as a combined anesthetic technique .\
\
###20032168\
BACKGROUND	Lessons in the Alexander Technique and exercise prescription proved effective for managing low back pain in primary care in a clinical trial .\
OBJECTIVE	To understand trial participants ' expectations and experiences of the Alexander Technique and exercise prescription .\
METHODS	A questionnaire assessing attitudes to the intervention , based on the Theory of Planned Behaviour , was completed at baseline and 3-month follow-up by 183 people assigned to lessons in the Alexander Technique and 176 people assigned to exercise prescription .\
METHODS	Semi-structured interviews to assess the beliefs contributing to attitudes to the intervention were carried out at baseline with14 people assigned to the lessons in the Alexander Technique and 16 to exercise prescription , and at follow-up with 15 members of the baseline sample .\
RESULTS	Questionnaire responses indicated that attitudes to both interventions were positive at baseline but became more positive at follow-up only in those assigned to lessons in the Alexander Technique .\
RESULTS	Thematic analysis of the interviews suggested that at follow-up many patients who had learned the Alexander Technique felt they could manage back pain better .\
RESULTS	Whereas many obstacles to exercising were reported , few barriers to learning the Alexander Technique were described , since it ` made sense ' , could be practiced while carrying out everyday activities or relaxing , and the teachers provided personal advice and support .\
CONCLUSIONS	Using the Alexander Technique was viewed as effective by most patients .\
CONCLUSIONS	Acceptability may have been superior to exercise because of a convincing rationale and social support and a better perceived fit with the patient 's particular symptoms and lifestyle .\
\
###22936334\
BACKGROUND	The influences of exercising on cytokine response , fatigue and cardiorespiratory values are important aspects of rehabilitation in persons with multiple sclerosis ( PwMS ) .\
BACKGROUND	Exercise performed within these programs is often practised in water but the effects of immersion on PwMS have not been systematically investigated .\
OBJECTIVE	The objective of this study is to determine differences in cytokine and neurotrophin concentrations , fatigue and cardiorespiratory values in response to 3 week endurance training conducted on a cycle ergometer or an aquatic bike .\
METHODS	A randomized controlled clinical trial was conducted in 60 MS patients ( Expanded Disability Status Scale range 1.0-6 .5 ) .\
METHODS	Resting serum levels of brain-derived neurotrophic factor ( BDNF ) , nerve growth factor ( NGF ) , Interleukin-6 , soluble receptor of IL-6 and tumor necrosis factor alpha , and concentrations in response to cardiopulmonary exercise test ( CPET ) , fatigue and cardiorespiratory values were determined at entry and discharge .\
METHODS	Subjects performed daily 30 minute training at 60 % of VOmax .\
RESULTS	Cytokines and neurotrophins showed no significant differences between groups over the training intervention .\
RESULTS	Within the water group BDNF resting and post-CPET concentrations ( p < 0.05 ) showed a significant increase and NGF tended to increase after the training intervention .\
RESULTS	Short-term effects on BDNF ( CEPT ) tended to increase at the start and significantly thereafter ( p < 0.05 ) .\
RESULTS	No changes occurred in the land group .\
RESULTS	Other cytokines and fatigue scores remained unchanged over the training period .\
RESULTS	Cardiorespiratory values improved significantly over time within both groups .\
CONCLUSIONS	This study indicates that aquatic training activates BDNF regulation and can be an effective training method during rehabilitation in PwMS .\
\
###7930246\
OBJECTIVE	Three dosage regimens of a new recombinant glycosylated prourokinase ( A-74187 ) were evaluated by measuring coronary artery patency at 90 min in patients with acute myocardial infarction .\
BACKGROUND	Prourokinase is a thrombolytic drug with unique pharmacologic properties that may be clinically advantageous .\
METHODS	Aspirin ( 325 mg ) , intravenous heparin and prourokinase ( 60 - or 80-mg monotherapy or 60 mg `` primed '' with a preceding bolus dose of 250,000 IU of recombinant urokinase ) were administered to 128 patients .\
METHODS	Coronary angiography was performed at 60 min ( wherever possible ) , 90 min ( primary end point ) and 24 h to determine arterial patency and reocclusion rates .\
METHODS	Plasma was collected serially to measure fibrinogen , plasminogen , thrombin antithrombin III and fibrinopeptide A. Clinical events until hospital discharge were recorded .\
RESULTS	The coronary artery patency rate at 90 min was similar for all three regimens , averaging 73 % ( 95 % confidence interval [ CI ] 64 % to 80 % ) ; Thrombolysis in Myocardial Infarction ( TIMI ) grade 3 flow rates averaged 52 % ( 95 % CI 42 % to 61 % ) .\
RESULTS	Arterial patency at 60 min was 62 % ( 95 % CI 50 % to 73 % ) , and reocclusion occurred in 1.4 % ( 95 % CI 0.1 % to 4.1 % ) .\
RESULTS	Prourokinase demonstrated relative fibrin specificity at all doses studied .\
RESULTS	Fibrinopeptide A and thrombin antithrombin III levels were elevated at baseline and declined rapidly during the 1st 12 h.\
RESULTS	There was no difference in the baseline values of these thrombin markers between patients with patent versus closed arteries at 90 min .\
RESULTS	There was one death ; no strokes occurred .\
CONCLUSIONS	A-74187 prourokinase is a rapid-acting , effective fibrin-specific thrombolytic agent .\
CONCLUSIONS	Reocclusion was unusual , possibly because of aggressive anticoagulation with intravenous heparin or unique features of the drug .\
CONCLUSIONS	Full definition of the clinical effectiveness of this drug merits examination in future randomized trials evaluating clinical and angiographic effectiveness .\
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###22411639\
BACKGROUND	Ketorolac ( KT ) is an intravenous ( IV ) nonsteroidal anti-inflammatory drug ( NSAID ) for acute , moderate pain .\
BACKGROUND	KT is safe , but may be linked to increased risk of post-tonsillectomy hemorrhage .\
BACKGROUND	The safety and efficacy of KT following primary endoscopic sinus surgery ( ESS ) is unknown .\
METHODS	All patients underwent primary ESS and septoplasty .\
METHODS	Patients randomly received either IVKT 30 mg or IV fentanyl ( IVF ) 25 g postprocedure .\
METHODS	Postoperative pain was recorded at 0 , 30 , and 60 minutes via visual analog scale ( VAS ) , and patients received as needed fentanyl and hydrocodone/acetaminophen for additional pain .\
METHODS	Postoperative bleeding questionnaires were completed on postoperative days 1 and 7 ( POD 1 and POD 7 ) .\
METHODS	Preoperative and POD 7 hemoglobin was assessed .\
RESULTS	A total of 34 patients enrolled in the study over 1 year .\
RESULTS	Sixteen patients received IVKT and 18 patients received IVF .\
RESULTS	The average time of administration was 23 6 minutes postprocedure .\
RESULTS	There were no significant differences in preoperative and postoperative hemoglobin levels between groups and bleeding assessments .\
RESULTS	There were no incidences of postoperative hemorrhage .\
RESULTS	There was no significant difference in pain VAS between the IVKT and IVF groups ( 3.5 , 3.2 , 2.1 vs 3.0 , 4.4 , 3.8 at 0 , 30 , and 60 minutes , respectively ) .\
RESULTS	There was no significant difference between the number of doses of supplemental analgesics for the IVKT and IVF groups ( 2.0 vs 3.4 doses IV ; 1.0 vs 1.4 doses orally , respectively ) .\
CONCLUSIONS	In this study , IVKT was a safe analgesic in the setting of primary ESS .\
CONCLUSIONS	There was no increased risk of hemorrhage or acute blood-loss anemia .\
CONCLUSIONS	IVKT did not appear to offer statistically significant pain control over IVF .\
\
###20047702\
BACKGROUND	Referral for brief intervention among people who misuse alcohol is reported to be effective but its impact among those who present to services following deliberate self-harm ( DSH ) has not been examined .\
METHODS	Consecutive patients who presented to an Emergency Department ( ED ) following an episode of DSH were screened for alcohol misuse .\
METHODS	Those found to be misusing alcohol were randomly assigned to brief intervention plus a health information leaflet or to a health information leaflet alone .\
METHODS	The primary outcome was whether the patient reattended an ED following a further episode of DSH during the subsequent 6 months .\
METHODS	Secondary outcomes were alcohol consumption , mental health and satisfaction with care measured 3 and 6 months after randomization .\
RESULTS	One hundred and three people took part in the study .\
RESULTS	Follow-up data on our primary outcome were obtained for all subjects and on 63 % for secondary outcomes .\
RESULTS	Half those referred for brief intervention received it .\
RESULTS	Repetition of DSH was strongly associated with baseline alcohol consumption , but not influenced by treatment allocation .\
RESULTS	There was a non-significant trend towards the number of units of alcohol consumed per drinking day being lower among those randomized to brief intervention .\
CONCLUSIONS	Referral for brief intervention for alcohol misuse following an episode of DSH may not influence the likelihood of repetition of self-harm .\
CONCLUSIONS	Longer-term interventions may be needed to help people who deliberately harm themselves and have evidence of concurrent alcohol misuse .\
\
###16642229\
OBJECTIVE	To evaluate the role of preserved pleural integrity in postoperative pain and respiratory functional status in patients undergoing coronary revascularization .\
METHODS	Two hundred forty patients undergoing on-pump coronary artery bypass grafting between March 2004 and February 2005 were included in the present study .\
METHODS	The patients were prospectively randomized and divided into either an opened pleura ( OP ) group ( n = 120 , patients with an OP ) or a closed pleura ( CP ) group ( n = 120 , patients whose pleural integrity was preserved ) .\
METHODS	Preoperative patient characteristics were similar .\
METHODS	Postoperative respiratory functions were compared between the groups by chest x-rays , respiratory functional tests and arterial blood gas analyses .\
METHODS	Postoperative pain was compared by using a multidimensional pain score .\
METHODS	All the tests were examined by the same blinded clinician .\
RESULTS	The mean age of the patients was 60.4 + / -8.8 years .\
RESULTS	Postoperative bleeding and the duration of hospital stay were markedly higher in the OP group than in the CP group .\
RESULTS	The incidences of atelectasis and pleural effusion were also significantly higher in the OP group ( P < 0.01 ) .\
RESULTS	Respiratory functions and postoperative pain scores were better in the CP group ( P < 0.01 and P = 0.008 , respectively ) .\
CONCLUSIONS	Preserving pleural integrity has beneficial effects on the respiratory functions and postoperative pain after coronary revascularization .\
CONCLUSIONS	The preservation of pleural integrity results in better respiratory function , decreased hospital stay and cost , and as a consequence , a better surgical outcome .\
\
###18377153\
OBJECTIVE	In behavioral research directed at the treatment of type 2 diabetes , the challenge is to understand how interventions might facilitate long-term lifestyle changes .\
OBJECTIVE	The Mediterranean Lifestyle Program ( MLP ) is an intervention for postmenopausal women diagnosed with type 2 diabetes that has shown promising effects on outcomes that include increased physical activity and reduced fat consumption .\
OBJECTIVE	The present study extended previous findings by evaluating diet-specific and activity-specific social-ecological resources as possible mediators of intervention effects over a 2-year period .\
METHODS	Percent calories from saturated fat and caloric expenditure per week in all physical activities were assessed with self-report questionnaires .\
RESULTS	The MLP was successful in increasing participants ' use of diet-specific and activity-specific family/friend and neighborhood resources .\
RESULTS	There was some evidence that changes in those resources mediated intervention effects on saturated fat consumption and physical activity outcomes .\
CONCLUSIONS	The experimental manipulation of mediators and the demonstrated mediational effects provided some support for the conclusion that social-ecological resources can contribute to improvements in healthful lifestyles for women with type 2 diabetes .\
\
###22867978\
OBJECTIVE	To assess the effect of the use of containers with an adapted sterilizing filter on the contamination of autologous serum eyedrops .\
METHODS	Prospective , consecutive , comparative , and randomized study .\
METHODS	Thirty patients with Sjgren syndrome .\
METHODS	One hundred seventy-six autologous serum containers used in home therapy were studied ; 48 of them included an adapted filter ( Hyabak ; Thea , Clermont-Ferrand , France ) , and the other 128 were conventional containers .\
METHODS	Containers equipped with a filter were tested at 7 , 14 , 21 , and 28 days of use , whereas conventional containers were studied after 7 days of use .\
METHODS	In addition , testing for contamination was carried out in 14 conventional containers used during in-patient therapy every week for 4 weeks .\
METHODS	In all cases , the preparation of the autologous serum was similar .\
METHODS	Blood agar and chocolate agar were used as regular culture media for the microbiologic studies , whereas Sabouraud agar with chloramphenicol was the medium for fungal studies .\
METHODS	Microbiologic contamination of containers with autologous serum eyedrops .\
RESULTS	Only one of the containers with an adapted sterilizing filter ( 2.1 % ) became contaminated with Staphylococcus epidermidis after 1 month of treatment , whereas the contamination rate among conventional containers reached 28.9 % after 7 days of treatment .\
RESULTS	The most frequent germs found in the samples were coagulase-negative Staphylococcus ( 48.6 % ) .\
RESULTS	With regard the containers used in the in-patient setting , 2 ( 14.3 % ) became contaminated after 2 weeks , 5 ( 35.7 % ) became contaminated after 3 weeks , and 5 ( 50 % ) became contaminated after 4 weeks , leaving 7 ( 50 % ) that did not become contaminated after 1 month of treatment .\
CONCLUSIONS	Using containers with an adapted filter significantly reduces the contamination rates in autologous serum eyedrops , thus extending the use of such container by the patients for up to 4 weeks with virtually no contamination risks .\
\
###15165091\
OBJECTIVE	Pleurodesis is generally regarded to give the best palliation in recurrent pleural effusion .\
OBJECTIVE	Talc is now increasingly recommended but in our department quinacrine has been used successfully for many decades with good results and only minor side effects .\
OBJECTIVE	It was therefore decided to make a prospective randomized clinical study comparing quinacrine ( 500 mg ) with talc ( 5 g ) with regard to efficacy and safety .\
METHODS	One hundred and ten eligible consecutive patients with recurrent and or malignant effusions , from 1 March 1996 till 31 March 1999 were randomized to chemical pleurodesis with either talc or quinacrine through a chest drainage tube after medical thoracoscopy .\
METHODS	Patients were evaluated with chest radiographs at 2 weeks and 2 , 4 , and 6 months after pleurodesis .\
RESULTS	Chi-square test showed 84 % power to distinguish between the groups and 10 % to determine the primary endpoint .\
RESULTS	Primary success ( fluid production < 50ml/24h within the first 6 days ) was 96 % of 56 patients with talc and 91 % of 54 patients with quinacrine , a non-significant difference ( P = 0.46 ) .\
RESULTS	Quinacrine patients needed a repeated treatment in 31 % ( 17 patients ) and talc patients in 7 % ( 4 patients ) ( P < 0.05 ) .\
RESULTS	Side effects were minor with no significant difference between the substances .\
CONCLUSIONS	Both substances are effective .\
CONCLUSIONS	Talc treatment had less often to be repeated .\
CONCLUSIONS	This indicates that the recommendation of talc for pleurodesis is well founded .\
CONCLUSIONS	However , quinacrine is a good alternative .\
\
###19608429\
OBJECTIVE	Leucocyte filtration of salvaged blood has been suggested to prevent patients from receiving activated leucocytes during auto-transfusion in cardiac surgery .\
OBJECTIVE	This study examines whether leucocyte filtration of salvaged blood affects the red blood cell ( RBC ) function and whether there is a difference between filtration of the concentrated and diluted blood on RBC function .\
METHODS	Forty patients undergoing cardiac surgery with cardiopulmonary bypass were randomly divided into a group receiving leucocyte filtration of concentrated blood ( High-Hct , n = 20 ) and another group receiving leucocyte filtration of the diluted blood ( Low-Hct , n = 20 ) .\
METHODS	During operation , all the salvaged blood , as well as the residual blood , from the heart-lung machine was filtered .\
METHODS	In the High-Hct group , blood was concentrated with a cell saver prior to filtration , whereas in the Low-Hct group , blood was filtered without concentration .\
METHODS	RBC function was represented by RBC aggregation and deformability measured by a laser-assisted optical rotational cell analyser and by the RBC 2,3-diphosphoglycerate ( 2,3-DPG ) and adenosine triphosphate ( ATP ) contents with conventional biochemical tests .\
RESULTS	Leucocyte filtration of diluted blood with a low haematocrit ( 14 + / -4 % ) did not affect RBC function .\
RESULTS	However , when the concentrated blood with a high haematocrit ( 69 + / -12 % ) was filtered , there was a reduction of ATP content in RBCs after passing through the filter ( from 1.45 + / -0.57 micromol g ( -1 ) Hb to 0.92 + / -0.75 micromol g ( -1 ) Hb , p < 0.05 ) .\
RESULTS	For patients who received the concentrated blood , their in vivo RBC function did not differ from those who received diluted blood .\
CONCLUSIONS	Leucocyte filtration of the diluted salvaged blood during cardiac surgery does not affect RBC function , but it tends to deplete the ATP content of RBCs as the salvaged blood has been concentrated prior to filtration .\
\
###22333443\
OBJECTIVE	To compare the clinical results between computer assisted minimally invasive spine surgery ( CAMISS ) and traditional open fixation surgery which used in thoracolumbar fractures .\
METHODS	A prospective randomized controlled trial of patients who had undergone surgery for thoracolumbar fracture from January 2006 to March 2011 was performed .\
METHODS	The patients were randomly divided into CAMISS group and traditional open treatment group ( control group ) by random number table .\
METHODS	Clinical results were assessed by comparing the following parameters between patients who had undergone CAMISS or traditional open surgery : operative time , estimated blood loss , visual analogue scale ( VAS ) of the low back pain , the accuracy of pedicle screw , the status and the correction of kyphosis .\
RESULTS	Forty-seven patients underwent CAMISS , and fifty patients underwent traditional open surgery .\
RESULTS	The follow-up periods were 3 - 50 months ( mean 12 months ) .\
RESULTS	According to the preoperative data , the two groups did not differ with respect to age , gender , marriage , occupation , mechanism of injury , classification of fracture , preoperative VAS scores of the low back pain , preoperative functional spine unit ( FSU ) Cobb 's angle and preoperative local angle of the fracture vertebral body ( P > 0.05 ) .\
RESULTS	Compare to the control group , the patients who got CAMISS had more accuracy of pedicle screw , less blood loss , short immobilized time , lower postoperative fever , and better VAS score of the low back pain ( t = 2.162 - 8.736 , P < 0.05 ) .\
RESULTS	The improvement of FSU Cobb 's angle and local angle of the fracture vertebral body were better at control group after operation ( 13.8 6.8 vs. 10.9 5.5 , 11.0 6.0 vs. 7.7 4.8 , t = 2.108 and 2.610 , P < 0.05 ) .\
RESULTS	But there was no significant difference of the FSU Cobb 's angle , or local angle of the fracture vertebral body between the two groups at post-operation and follow-up ( P > 0.05 ) .\
CONCLUSIONS	CAMISS has the characteristics of fewer traumas , less bleeding , faster recovery , high accuracy of pedicle screws .\
CONCLUSIONS	It has comparable vertebral deformity correction and fixation result of the traditional open operation .\
\
###25299536\
OBJECTIVE	The purpose of this study was to determine whether whole-body vibration training could improve standing balance and muscle strength in children with Down syndrome .\
METHODS	This study was a randomized controlled trial studying 30 children ( 8-10 yrs old ) with Down syndrome .\
METHODS	They were assigned randomly using sealed envelopes , with 15 children allocated to the control group ( 9 boys , 6 girls ) and another 15 children allocated to the study group ( 8 boys , 7 girls ) .\
METHODS	The control group received a designed physical therapy program , whereas the study group received the same program given to the control group in addition to whole-body vibration training .\
METHODS	Both groups received the treatment sessions three times per week for 6 successive months .\
METHODS	Measurement of stability indices by using the Biodex Stability System as well as muscle strength of the knee flexors and extensors by using a handheld dynamometer was done before and after the 6 mos of the treatment program .\
RESULTS	Each group demonstrated significant improvements in stability indices and muscle strength after treatment ( P < 0.05 ) , with significantly greater improvements seen in the study group when compared with the control group ( P < 0.05 ) .\
CONCLUSIONS	Whole-body vibration may be a useful intervention modality to improve balance and muscle strength in children with Down syndrome .\
\
###22451113\
BACKGROUND	Although physical activity is beneficial for breast cancer survivors , the majority do not meet public health physical activity recommendations .\
BACKGROUND	The purpose of this study was to test a social cognitive theory model of physical activity behavior in a sample of long-term breast cancer survivors using both self-report and objective measures of physical activity .\
METHODS	Participants ( N = 1527 ) completed measures of physical activity , self-efficacy , goals , outcome expectations , fatigue , and social support at baseline and 6-month follow-up .\
METHODS	A subsample ( n = 370 ) was randomly selected to wear an accelerometer .\
METHODS	It was hypothesized that self-efficacy directly and indirectly influences physical activity through goals , social support , fatigue , and outcome expectations .\
METHODS	Relationships were examined using panel analysis within a covariance modeling framework .\
RESULTS	The hypothesized model provided a good model-data fit ( ( 2 ) = 1168.73 , df = 271 , p = < 0.001 , CFI = 0.96 , SRMR = 0.04 ) in the full sample when controlling for covariates .\
RESULTS	At baseline , self-efficacy directly and indirectly , via goals , outcome expectations , and social support , influenced physical activity .\
RESULTS	These relationships were also supported across time .\
RESULTS	Additionally , the hypothesized model was supported in the subsample with accelerometer data ( 2 = 656.88 , df = 330 , p < 0.001 , CFI = 0.95 , SRMR = 0.05 ) .\
CONCLUSIONS	This study validates a social cognitive model for understanding physical activity behavior in long-term breast cancer survivors .\
CONCLUSIONS	Future studies should be designed to replicate this model in other breast cancer survivor populations , and the findings should be applied to the development of future physical activity programs and studies for this population .\
\
###17693914\
OBJECTIVE	To study the ability of volume-controlled ventilation and medicated ( normal saline plus surfactant ) bronchoalveolar lavage in aspiration to reduce the duration of intubation and improve gas exchange .\
METHODS	: Randomized controlled clinical trial .\
METHODS	Pediatric intensive care unit .\
METHODS	Twenty children , 1 month to 16 yrs old , who were intubated and mechanically ventilated , were randomized within 6 hrs of aspiration to receive volume-controlled ventilation plus medicated bronchoalveolar lavage ( treatment group ) or the same ventilation and bronchosuction ( control group ) .\
METHODS	Volume-controlled ventilation and positive end-expiratory pressure ( 10-12 cm H2O ) were applied .\
METHODS	Medicated bronchoalveolar lavage was performed using five aliquots of 5 mL of saline plus 10 mg/mL Curosurf ( porcine surfactant , Chiesi Pharmaceutical SpA , Parma , Italy ) in infants , five boluses of 10 mL of saline plus 5 mg/mL Curosurf in children , and four boluses of 25 mL of saline with 2.4 mg/mL Curosurf in adolescents for each affected lobe .\
METHODS	One hour after bronchoalveolar lavage , 240 mg of Curosurf was administered locally .\
RESULTS	All patients survived .\
RESULTS	In the treatment group , days of intubation were 4.6 ( + / -1.07 ) , oxygenation index and Pao2/Fio2 improved significantly at 24 hrs , and statistical reduction in tidal volume mL/kg was observed from 36 hrs .\
RESULTS	In the control group , days of intubation were 11.8 ( + / -3.22 ) ( p < .0001 ) , no improvement in oxygenation was noted , and pneumonia was observed in seven children ( 70 % ) .\
CONCLUSIONS	Even though this was an unblinded small clinical trial and low tidal volume strategy was not employed at an early stage after lung injury , there is some evidence that bronchoalveolar lavage with normal saline and surfactant may have clinical value in treating severe aspiration syndrome in children .\
CONCLUSIONS	More clinical studies are warranted to overcome study limitations and potential bias .\
\
###10626189\
OBJECTIVE	Few data are available concerning the short and long-term effects of beta-IFN in patients with chronic hepatitis C.\
METHODS	We randomized 61 consecutive patients with HCV-related cirrhosis to receive : a ) natural beta-IFN with a 6 MU/tiw for 6 months followed by 3 MU/tiw for 6 months schedule or b ) no treatment .\
METHODS	Biochemical and virological response was defined by normalization of ALT and negativization of serum HCV-RNA .\
METHODS	Patients were followed-up for 5 years .\
RESULTS	A biochemical end-of-therapy response ( ETR ) was observed in 5/38 patients ( 13 % ) who received beta-IFN compared to 2/23 ( 9 % ) of untreated cases , but a virological ETR appeared only in 4/38 ( 11 % ) treated cases .\
RESULTS	At long-term follow-up , 6 cases ( 16 % ) who received beta-IFN and 4 untreated ( 17 % ) developed a persistent normalization of alanine aminotransferase ( ALT ) but only 2 ( 5 % ) and 1 ( 4 % ) , respectively , were also HCV-RNA negative .\
RESULTS	The cumulative probability of liver decompensation ( variceal bleeding ascites or hepatic encephalopathy ) at 60 months was 24 % in treated and 35 % in untreated cases .\
RESULTS	Hepatocellular carcinoma developed in 2 treated and in 1 untreated patients .\
CONCLUSIONS	beta-IFN therapy was not associated with a significant improvement either in biochemical or virological response in cirrhotic patients with chronic hepatitis C. No significant reduction of cirrhosis related clinical events was linked to treatment .\
\
###9481530\
OBJECTIVE	We investigated whether there was a growth or morbidity response to zinc supplementation .\
METHODS	The study was randomized , placebo-controlled , and double-blind .\
METHODS	Children were recruited at clinics in Kingston , Jamaica , and supplemented at home .\
METHODS	Children selected were singletons aged 6-24 months , and stunted ( < -2.0 s.d. length for age , NCHS references ) .\
METHODS	They were stratified by sex and age and randomly assigned to receive zinc supplement ( n = 31 ) or placebo ( n = 30 ) .\
METHODS	Four children were excluded because of hospitalization ; all others had all measurements .\
METHODS	Adequately nourished children ( n = 24 ) were recruited from a well-baby clinic .\
METHODS	The supplement provided 5 mg elemental zinc in a syrup daily for 12 weeks ; the placebo comprised the syrup only .\
METHODS	Caretakers were interviewed to obtain social background data , number of clinic visits and hospitalizations .\
METHODS	Anthropometric measurements were done on enrolment , and after 6 weeks , 12 weeks and 12 months .\
METHODS	Children 's health was determined by weekly questionnaire to caretakers of the undernourished groups during the supplementation period .\
RESULTS	The supplemented and placebo groups were similar on enrolment .\
RESULTS	The adequately nourished children were from significantly better socio-economic circumstances .\
RESULTS	Mean initial hair zinc content was 5.5 + / - 4.8 mumol/g ( supplemented group ) and 6.7 + / - 12.1 mumol/g ( placebo ) ( n.s. ) .\
RESULTS	Regression analyses showed that there were no significant effects of supplementation on length , height or head circumference , nor on the incidence of any morbidity symptom .\
RESULTS	Mean duration of the episodes was significantly shorter for skin rashes in the supplemented group compared with the control group ( ANCOVA , P = 0.02 ) , and longer for vomiting ( P = 0.02 ) .\
RESULTS	The incidence of hospitalization was significantly greater in the control group ( Fisher 's exact test , P = 0.02 ) .\
CONCLUSIONS	Zinc supplementation reduced the hospitalizations which probably reflect severity of morbidity , but did not improve growth .\
\
###17828605\
BACKGROUND	This study focused on the change in the range of motion ( ROM ) during the perioperative period , i.e. , the preoperative and intraoperative ROM , and that on discharge , and compared the difference between posterior cruciate ligament-retaining ( PCLR ) and - sacrificing ( PCLS ) prostheses .\
METHODS	In this prospectively randomized study , we compared the changes in the ROM in PCLR ( n = 50 ) and PCLS ( n = 50 ) total knee arthroplasties .\
RESULTS	The mean flexion in PCLR prostheses was 130.0 degrees preoperatively , 120.0 degrees intraoperatively , and 105.0 degrees at discharge , and 125.0 degrees , 120.0 degrees , and 100.0 degrees , respectively , in PCLS .\
RESULTS	The designs did not differ statistically in each period ( P > 0.05 ) .\
RESULTS	Both designs showed significant correlations between the preoperative and intraoperative ROM , and between the preoperative and discharge ROM .\
RESULTS	Only the PCLS showed a significant correlation between the intraoperative and discharge ROM , and a significant difference was observed in correlation of rank coefficient between the two prostheses ( P < 0.001 ) .\
CONCLUSIONS	The PCLS design has an advantage in rehabilitation planning because of the predictable changes in the ROM during the perioperative period , although the acquired average ROM at discharge did not differ statistically .\
\
###22240770\
OBJECTIVE	Our purpose was to evaluate intraindividually the performance of contrast-enhanced magnetic resonance angiography ( MRA ) and non-contrast MRA for aortic root diameter measurements and to compare the results with routinely performed echocardiography in patients with suspected Marfan syndrome .\
METHODS	Aortic roots were examined prospectively in 51 consecutive patients with suspected Marfan syndrome by using contrast-enhanced MRA and non-contrast MRA at 1.5 T. Two readers independently measured aortic root diameters at the annulus , sinuses of Valsalva and sinutubular junction in both data sets and compared results with echocardiographic data .\
METHODS	Intraclass correlation coefficient , Pearson correlation coefficient , Bland-Altman , and two-sided t-test were used to assess agreement between observers and methods .\
RESULTS	38 ( 74.5 % ) of the 51 patients ( 25 female , 26 male ; mean age 37.1 13.7 years ) had Marfan syndrome .\
RESULTS	Both , contrast-enhanced MRA and non-contrast MRA measurements of the sinuses of Valsalva revealed a strong correlation with echocardiography ( r = 0.850 and r = 0.893 , respectively ) .\
RESULTS	Intraclass correlation was markedly better for non-enhanced MRA ( r = 0.904 ) when compared to contrast-enhanced MRA ( r = 0.690 ) .\
RESULTS	Image quality ( p < 0.001 ) as well as interobserver agreement ( p < 0.0042 ) of measurements of the sinuses of Valsalva was significantly better for non-enhanced MRA than for contrast-enhanced MRA .\
CONCLUSIONS	Non-contrast MRA was more reliable and more valid than contrast-enhanced MRA for assessment of aortic root dimensions in patients with suspected Marfan syndrome .\
CONCLUSIONS	Therefore contrast agents can be omitted for establishing the diagnosis of aortic involvement in Marfan syndrome .\
\
###9478065\
BACKGROUND	The purpose of this study was to determine whether histomorphometric changes , which are developed during prolonged hypokinesia ( decreased number of km/day ) could be prevented or minimized with a daily intake of fluid and salt supplementation ( FSS ) .\
METHODS	The studies on hypokinesia ( HK ) were performed for 364 days on thirty endurance trained male volunteers ( ETV ) in the age of 19 to 25 years , with an average peak oxygen uptake ( POU ) , of 65 mL/kg -1 .\
METHODS	min-1 .\
METHODS	All volunteers were divided into three equal groups : ten volunteers were placed on a continuous regime of exercise of 13.8 km/day and served as control subjects .\
METHODS	Ten volunteers were subjected to continuous HK without FSS and were considered as the unsupplemented hypokinetic subjects ( UHS ) .\
METHODS	The remaining volunteers were under continuous HK and FSS and were considered as the supplemented hypokinetic subjects ( SHS ) .\
METHODS	For the simulation of the hypokinetic effect , the SHS and UHS groups were kept continuously under an average of 2.7 km/day for the duration of the experiment .\
METHODS	Prior to exposure to HK , all volunteers were on the same exercise regime as the control subjects .\
METHODS	During the 60 day pre-HK period and during the experimental period , the following parameter were determined : sodium and calcium in urine and plasma , hemoglobin ( Hb ) , hematocrit ( Hct ) , plasma osmolality , plasma protein concentration , plasma renin activity , aldosterone and parathyroid hormone ( PTH ) concentration .\
RESULTS	In the UHS iliac crest cancellous bone volume and PTH content decreased , urinary and plasma electrolytes , plasma renin activity , aldosterone , plasma osmolality , protein content , Hb and Hct increased significantly .\
RESULTS	In the SHS iliac crest cancellous bone volume and PTH content increased , while electrolytes in urine and plasma Hb , Hct , osmolality , protein , aldosterone and plasma renin activity decreased .\
CONCLUSIONS	It was concluded that daily intake of FSS may be used to minimize or prevent histomorphometric changes in endurance trained volunteers during exposure to prolonged HK .\
\
###24298765\
OBJECTIVE	To observe the efficacy on post-stroke mild cognitive impairment ( MCI ) treated with acupuncture at Jing-well points on the differentiated meridians and temple-three-needle therapy .\
METHODS	Seventy-three of stroke patients were randomized into an acupuncture group ( 37 cases ) and a conventional treatment group ( 36 cases ) .\
METHODS	Twenty healthy aged people in physical examination were collected as a control group .\
METHODS	In the acupuncture group , on the basis of the conventional treatment of internal medication , the acupuncture at Jing-well points on the differentiated meridians and temple-three-needle therapy were applied .\
METHODS	In the conventional treatment group , no any therapy was used except the conventional treatment of internal medication .\
METHODS	In the control group , no any intervention was adopted .\
METHODS	Neuroscan Nuamps electroencephalogram recording analysis system was used to determine the event-related potentials P300 , and the amplitude and mini mental state examination ( MMSE ) score was observed before and after treatment in both groups .\
RESULTS	After treatment , in the acupuncture group , P300 latent stage was shortened , and the amplitude and the score of MMSE were increased ( P < 0.05 , P < 0.01 ) .\
RESULTS	In the conventional treatment group , above indices were not changed obviously as compared with that before treatment ( all P > 0.05 ) .\
RESULTS	Compared with the conventional treatment group , the differences in P300 latent stage , amplitude and MMSE score were remarkable in the acupuncture group ( P < 0.05 , P < 0.01 ) .\
CONCLUSIONS	The acupuncture at Jing-well points on the differentiated meridians and temple-three-needle therapy improves the cognitive function of the patients with MCI .\
\
###19783539\
BACKGROUND	The purpose of this study was to determine the potential for the Pentax AWS and the Glidescope to reduce the difficulty of tracheal intubation in patients at increased risk for difficult tracheal intubation , in a randomized , controlled clinical trial .\
METHODS	Seventy-five consenting patients presenting for surgery requiring tracheal intubation , and who were deemed to possess characteristics indicating an increased risk for difficult tracheal intubation , were randomly assigned to undergo intubation using a Macintosh , AWS , or Glidescope laryngoscope ( n = 25 patients per group ) .\
METHODS	All patients were intubated by one of three anaesthetists experienced in the use of each laryngoscope .\
RESULTS	Both the Glidescope and the AWS significantly reduced the intubation difficulty score compared with the Macintosh .\
RESULTS	The rate of successful tracheal intubation was lower with the Macintosh ( 84 % ) compared with the Glidescope ( 96 % ) or the AWS ( 100 % ) .\
RESULTS	There were no differences in the duration of tracheal intubation attempts between the devices .\
RESULTS	Both the Glidescope and the AWS significantly reduced the need for additional manoeuvres and improved the Cormack and Lehane view obtained at laryngoscopy , compared with the Macintosh .\
RESULTS	Tracheal intubation with the AWS but not the Glidescope reduced the degree of haemodynamic stimulation compared with the Macintosh laryngoscope .\
CONCLUSIONS	The AWS and the Glidescope laryngoscopes reduced the difficulty of tracheal intubation to a similar extent compared with the Macintosh laryngoscope , in patients at increased risk for difficult tracheal intubation .\
\
###23260609\
BACKGROUND	Little information exists on the receipt of mammography by African American women with intellectual disabilities .\
BACKGROUND	Given the high rates of mortality from breast cancer among African American women and low screening rates among women with intellectual disabilities , it is important to understand the health screening behavior of this population .\
OBJECTIVE	We compared rates of mammography receipt among African American and White women with intellectual disabilities ( n = 92 ) living in community settings in one Southeastern state in the United States .\
METHODS	Data were collected from women 's medical records or abstraction forms obtained from medical practices .\
METHODS	Multivariate logistic regressions were modeled for receipt of mammography in one year , one of two years , or both study years ( 2008 - 2009 ) .\
METHODS	Covariates included the women 's age , living arrangement , severity of impairment , and urban/rural residence location .\
RESULTS	In 2009 , 29 % of African American women and 59 % of White women in the sample received mammograms .\
RESULTS	Similar disparities were found for receipt of mammography in either 2008 or 2009 and both 2008 and 2009 .\
RESULTS	These disparities persisted after inclusion of model covariates .\
RESULTS	White women with intellectual disabilities received mammograms at adjusted rates that were nearly three to five times higher than African American women .\
CONCLUSIONS	African American women with intellectual disabilities receive mammography at significantly lower rates than White women with intellectual disabilities .\
CONCLUSIONS	Assertive measures to improve the screening rates for African American women with intellectual disabilities are urgently needed .\
\
###24103444\
OBJECTIVE	To evaluate the effect of specialist geriatric medical management on the outcomes of at risk older people discharged from acute medical assessment units .\
METHODS	Individual patient randomised controlled trial comparing intervention with usual care .\
METHODS	Two hospitals in Nottingham and Leicester , UK .\
METHODS	433 patients aged 70 or over who were discharged within 72 hours of attending an acute medical assessment unit and at risk of decline as indicated by a score of at least 2 on the Identification of Seniors At Risk tool .\
METHODS	Assessment made on the acute medical assessment unit and further outpatient management by specialist physicians in geriatric medicine , including advice and support to primary care services .\
METHODS	The primary outcome was the number of days spent at home ( for those admitted from home ) or days spent in the same care home ( if admitted from a care home ) in the 90 days after randomisation .\
METHODS	Secondary outcomes were determined at 90 days and included mortality , institutionalisation , dependency , mental wellbeing , quality of life , and health and social care resource use .\
RESULTS	The two groups were well matched for baseline characteristics , and withdrawal rates were similar in both groups ( 5 % ) .\
RESULTS	Mean days at home over 90 days ' follow-up were 80.2 days in the control group and 79.7 in the intervention group .\
RESULTS	The 95 % confidence interval for the difference in means was -4.6 to 3.6 days ( P = 0.31 ) .\
RESULTS	No significant differences were found for any of the secondary outcomes .\
CONCLUSIONS	This specialist geriatric medical intervention applied to an at risk population of older people attending and being discharged from acute medical units had no effect on patients ' outcomes or subsequent use of secondary care or long term care .\
\
###15864235\
BACKGROUND	Low-density lipoprotein cholesterol ( LDL-C ) is the primary therapeutic target in the National Cholesterol Education Program Adult Treatment Panel III ( ATP III ) guidelines .\
BACKGROUND	This study tested the hypothesis that ezetimibe/simvastatin , a lipid-lowering agent that inhibits both intestinal cholesterol absorption and cholesterol synthesis , provides greater LDL-C reductions than atorvastatin across dose ranges .\
METHODS	This multicenter , double-blind , 6-week parallel-group study randomized 1902 patients with LDL-C above ATP III goal to atorvastatin ( 10 , 20 , 40 , or 80 mg ) or to ezetimibe/simvastatin ( 10/10 , 10/20 , 10/40 , or 10/80 mg ) .\
METHODS	Patients were stratified by prerandomization LDL-C level .\
RESULTS	At each milligram-equivalent statin dose comparison , and averaged across doses , ezetimibe/simvastatin provided greater LDL-C reductions ( 47 % -59 % ) than atorvastatin ( 36 % -53 % ) .\
RESULTS	Ezetimibe/simvastatin 10/40 and 10/80 mg also provided significantly greater high-density lipoprotein cholesterol ( HDL-C ) increases than atorvastatin 40 and 80 mg .\
RESULTS	Triglyceride reductions were similar for all comparisons .\
RESULTS	More ezetimibe/simvastatin than atorvastatin patients with coronary heart disease ( CHD ) or CHD risk equivalents attained the ATP III LDL-C goal of < 100 mg/dL and the optional LDL-C target of < 70 mg/dL .\
RESULTS	C-reactive protein reductions were similar between treatment groups .\
RESULTS	Consecutive elevations in alanine aminotransferase and/or aspartate aminotransferase occurred in significantly more atorvastatin patients than ezetimibe/simvastatin patients .\
RESULTS	No myopathy or liver-related adverse events led to study discontinuation with either drug .\
CONCLUSIONS	Ezetimibe/simvastatin was more effective than atorvastatin in lowering LDL-C at each dose comparison and provided greater increases in HDL-C at the 40 - and 80-mg statin dose .\
CONCLUSIONS	Ezetimibe/simvastatin is a highly efficacious , well-tolerated treatment option for hypercholesterolemic patients .\
\
###14656837\
OBJECTIVE	To test the hypothesis that the use of an automated external defibrillator by police and fire fighters results in higher discharge rates for out of hospital cardiac arrest .\
METHODS	Controlled clinical trial with initial random allocation of automated external defibrillators to first responders in four of the eight participating regions ; each region switched from control to experimental , and vice versa , every four months .\
METHODS	Amsterdam and surroundings , the Netherlands .\
METHODS	Patients with witnessed out of hospital cardiac arrests , identified by the emergency medical system between January 2000 and January 2002 .\
METHODS	Survival to hospital discharge ; return of spontaneous circulation ; admission to hospital .\
RESULTS	243 patients ( 65 % in ventricular fibrillation ) were included in the experimental area and 226 patients ( 67 % in ventricular fibrillation ) in the control area .\
RESULTS	The median time interval between collapse and first shock was 668 seconds in the experimental area and 769 seconds in the control area ( P < 0.001 ) .\
RESULTS	44 ( 18 % ) patients in the experimental area versus 33 ( 15 % ) patients in the control area were discharged ( odds ratio 1.3 ( 95 % confidence interval 0.8 to 2.2 ) , P = 0.33 ) , 139 ( 57 % ) experimental versus 108 ( 48 % ) control patients had return of spontaneous circulation ( 1.5 ( 1.0 to 2.2 ) , P = 0.05 ) , and 103 ( 42 % ) experimental versus 74 ( 33 % ) control patients were admitted ( 1.5 ( 1.1 to 1.6 ) , P = 0.02 ) .\
RESULTS	The median delay from receipt of call to dispatch of the ambulance was 120 seconds , and the delay to dispatch of the first responder was 180 seconds .\
CONCLUSIONS	Use of automated external defibrillators by first responders did not significantly increase survival to discharge from hospital , although it did improve return of spontaneous circulation and admission to hospital .\
CONCLUSIONS	Improved dispatch procedures should increase the success of programmes of first responders using external defibrillators .\
\
###11124669\
BACKGROUND	Anterior transposition of the inferior oblique muscle ( ATIO ) has become a popular surgical treatment for dissociated vertical deviation ( DVD ) , particularly in patients with coexisting inferior oblique muscle overaction ( IOOA ) .\
BACKGROUND	We wanted to assess whether adding a resection improves the outcome compared with standard anteriorization .\
METHODS	We undertook a prospective , randomized evaluation of ATIO , with and without a 7-mm resection , in patients with DVD of at least 5 PD in one eye .\
METHODS	We included 51 eyes of 30 patients , 26 eyes treated with the standard ATIO and 25 treated with a 7-mm resection added .\
METHODS	We recorded the size of the preoperative and final DVD , grade of the preoperative and final IOOA , rates of reoperation , and complications .\
METHODS	Mean follow-up was 15.4 months in the standard group and 25.0 months in the resection group , with a minimum of 4 months for all cases .\
RESULTS	The median preoperative and postoperative DVD was 12 PD and 4 PD in the standard group , respectively .\
RESULTS	This compared with 14 PD and 4 PD , respectively , in the resection group , representing no statistically significant difference in outcome .\
RESULTS	The presence or absence of IOOA did not influence the result of ATIO for either group .\
RESULTS	No significant complications of surgery occurred in either group .\
CONCLUSIONS	ATIO is an effective treatment for DVD and can be used to treat DVD in patients with or without IOOA , with few adverse effects .\
CONCLUSIONS	Our study revealed no advantage to adding a 7-mm resection to the standard procedure .\
\
###25562462\
OBJECTIVE	Initial medication response has been shown to predict treatment outcome across a variety of substance use disorders , but no studies have examined the predictive power of initial response to buprenorphine-naloxone in the treatment of prescription opioid dependence .\
OBJECTIVE	We therefore conducted a secondary analysis of data from the Prescription Opioid Addiction Treatment Study to determine whether initial response to buprenorphine-naloxone predicted 12-week treatment outcome in a prescription opioid-dependent population .\
METHODS	Using data from a multisite , randomized controlled trial of buprenorphine-naloxone plus counseling for DSM-IV prescription opioid dependence ( June 2006-July 2009 ) , we conducted a secondary analysis to investigate the relationship between initial medication response and 12-week treatment outcome to establish how soon the efficacy of buprenorphine-naloxone could be predicted ( N = 360 ) .\
METHODS	Outcomes were determined from the Substance Use Report , a self-report measure of substance use , and confirmatory urinalysis .\
METHODS	Predictive values were calculated to determine the importance of abstinence versus use at various time points within the first month of treatment ( week 1 , weeks 1-2 , 1-3 , or 1-4 ) in predicting successful versus unsuccessful treatment outcome ( based on abstinence or near-abstinence from opioids ) in the last 4 weeks of buprenorphine-naloxone treatment ( weeks 9-12 ) .\
RESULTS	Outcome was best predicted by medication response after 2 weeks of treatment .\
RESULTS	Two weeks of initial abstinence was moderately predictive of treatment success ( positive predictive value = 71 % ) , while opioid use in both of the first 2 weeks was strongly predictive of unsuccessful treatment outcome ( negative predictive value [ NPV ] = 84 % ) , especially when successful outcome was defined as total abstinence from opioids in weeks 9-12 ( NPV = 94 % ) .\
CONCLUSIONS	Evaluating prescription opioid-dependent patients after 2 weeks of buprenorphine-naloxone treatment may help determine the likelihood of successful outcome at completion of the current treatment regimen .\
BACKGROUND	ClinicalTrials.gov identifier : NCT00316277 .\
\
###16533677\
OBJECTIVE	Building upon the results of an observational study , this clinical trial aimed to test the hypothesis that conducting antenatal Down syndrome screening ( DSS ) at the same time as other tests result in higher rates of informed choice to accept DSS , than when it is conducted separately from other tests .\
METHODS	The trial used a cluster-randomised controlled design , with informed choice as the outcome measure .\
METHODS	The post of midwife was randomised to offer DSS at the same time as other tests ( combined visit ) or separately from other tests ( separate visit ) .\
RESULTS	Overall 43.5 % of women made an informed choice about DSS .\
RESULTS	There was no difference in rates of informed choice for women accepting DSS according to the method of conducting testing ( 23.7 % at combined visit versus 22.5 % at separate visit , OR = 1.1 , 95 % CI : 0.70-1 .7 , p = 0.67 ) .\
CONCLUSIONS	Rates of informed choice about DSS were low , but there was no evidence to support that hypothesis that conducting testing at that same time as other tests increased rates of informed choice .\
CONCLUSIONS	This may reflect the limitations of conducting the trial in one centre .\
\
###25740807\
BACKGROUND	To investigate the difference in clinical outcomes between large-diameter deep anterior lamellar keratoplasty ( L-DALK ) and standard DALK ( S-DALK ) for the treatment of keratoconus .\
METHODS	132 patients ( 132 eyes ) from the Zhongshan Ophthalmic Center with a clinical diagnosis of keratoconus were enrolled .\
METHODS	The participants were featured by the intolerance to rigid gas-permeable contact lenses or unsuccessful fitting of contact lenses .\
METHODS	Using stratified blocked randomisation , eligible eyes were allocated into the L-DALK group or the S-DALK group ( 66 eyes , respectively ) .\
METHODS	Postoperative uncorrected visual acuity ( UCVA ) , best spectacle-corrected visual acuity ( BSCVA ) , refractive sphere , manifest cylinder and spherical equivalent refractive error were tested at 6 , 12 , 18 and 24months after surgery .\
RESULTS	After surgery , the L-DALK group had better UCVA and BSCVA than the S-DALK group ( p = 0.000 and 0.021 , respectively ) .\
RESULTS	At 24months , mean BSCVA was 0.170.10 logarithm of the minimum angle of resolution ( logMAR ) ( Snellen equivalent , 20/25 ) in the L-DALK group vs 0.220.10 logMAR ( Snellen equivalent , 20/32 ) in the S-DALK group .\
RESULTS	Differences were observed between the L-DALK group and the S-DALK group in terms of refractive sphere ( p = 0.015 ) , manifest cylinder ( p = 0.014 ) and spherical equivalent refractive error ( p = 0.034 ) at any time interval postoperatively .\
RESULTS	At 24months , the mean spherical equivalent refractive error was -3.53.2 D and -5.22.6 D in the L-DALK and S-DALK groups , respectively .\
CONCLUSIONS	L-DALK can reduce the degree of postoperative myopia and manifest astigmatism and improve visual acuity outcomes in keratoconus compared with S-DALK .\
BACKGROUND	Chinese Clinical Trial Registry ( TRC-13003122 ) .\
\
###21871480\
OBJECTIVE	To compare the effect of two different types of short text message service ( SMS-text ) reminders on the uptake of screening mammogram .\
METHODS	A randomized controlled trial was conducted in 2010 among females aged between 40 and 75 , benefiting from the Health Insurance Plan at the American University of Beirut , whose cell phone numbers were available in their electronic medical records , and who did not do a mammogram in the past 2 years .\
METHODS	The sample ( n = 385 ) was randomly divided into two subgroups .\
METHODS	The first subgroup ( n1 = 192 ) received a general SMS-text inviting its members to do a mammogram while the second subgroup ( n2 = 193 ) received an additional informative SMS-text informing them about the benefits of mammogram screening .\
RESULTS	30.7 % ( 59 ) of subgroup 1 and 31.6 % ( 61 ) of subgroup 2 underwent a mammogram screening test during the 6 months follow up interval post-intervention ( Chi-square test , p-value 0.05 ) .\
RESULTS	There was no difference between the response rates in the two subgroups .\
CONCLUSIONS	A brief invitation SMS-text message for screening mammogram was found to be as effective as a detailed informative one .\
\
###23663813\
BACKGROUND	The Seattle Heart Failure Model ( SHFM ) is a well validated prediction model of all-cause mortality in patients with heart failure , but its relationship with generic health status measures has not been evaluated .\
BACKGROUND	We sought to investigate relationships between SHFM scores and health utility weights , which are necessary to estimate quality-adjusted life-years in cost-effectiveness analyses .\
RESULTS	We applied mixed linear regression to examine relationships between baseline SHFM scores and EQ-5D-derived health utilities collected longitudinally in a large clinical trial .\
RESULTS	A1-unit increase in SHFM score ( higher predicted mortality ) was associated with a 0.030 decrease in utility ( P < .001 ) and an additional 0.006 decrease per year ( P < .001 ) .\
RESULTS	With SHFM score modeled as a categorical variable , EQ-5D utilities for patients with rounded SHFM scores of 1 or 2 were significantly lower ( -0.041 and -0.053 , respectively ; both P < .001 ) and declined more rapidly over time ( -0.011 and -0.020 , respectively ; both P .004 ) than for patients with scores of -1 .\
CONCLUSIONS	Patients with higher SHFM-predicted mortality had significantly lower health utilities atbaseline and greater rates of decline over time , compared with patients with lower SHFM-predicted mortality .\
CONCLUSIONS	These relationships can be applied when examining the cost-effectiveness of heart failure interventions .\
\
###11774933\
OBJECTIVE	Sildenafil relaxes smooth muscle by blocking type 5 phosphodiesterase , which destroys nitric oxide-stimulated cyclic guanosine monophosphate .\
OBJECTIVE	The aim of this study is to investigate the change of lower esophageal sphincter ( LES ) and body motility with the lapse of time after sildenafil infusion in normal male adults .\
METHODS	After basal esophageal manometry in eight healthy male adult volunteers , we infused a 50-mg tablet of sildenafil dissolved in water in the stomach through the manometry catheter and observed the changes of LES and body motility with the lapse of time .\
METHODS	We randomized the study population into two groups , and esophageal manometry was repeated in LES and body sequence in four volunteers and in body and LES sequence in the other four volunteers immediately after sildenafil infusion .\
RESULTS	LES resting pressure significantly decreased after sildenafil infusion .\
RESULTS	The body peristaltic amplitude gradually decreased and eventually disappeared , and the latency increased significantly after sildenafil infusion in both the proximal and distal esophagus .\
CONCLUSIONS	These data support that nitric oxide mediates LES relaxation and the timing of esophageal peristalsis .\
CONCLUSIONS	In the future , sildenafil can be tried in some esophageal motor disorders , which have defects in nitric oxide neuromuscular communication .\
\
###24530788\
BACKGROUND	Moderate alcohol consumption is associated with a decrease in cardiovascular risk , but fermented beverages seem to confer greater cardiovascular protection due to their polyphenolic content .\
BACKGROUND	Circulating endothelial progenitor cells ( EPC ) are bone-marrow-derived stem cells with the ability to repair and maintain endothelial integrity and function and are considered as a surrogate marker of vascular function and cumulative cardiovascular risk .\
BACKGROUND	Nevertheless , no study has been carried out on the effects of moderate beer consumption on the number of circulating EPC in high cardiovascular risk patients .\
OBJECTIVE	To compare the effects of moderate consumption of beer , non-alcoholic beer and gin on the number of circulating EPC and EPC-mobilizing factors .\
METHODS	In this crossover trial , 33 men at high cardiovascular risk were randomized to receive beer ( 30 g alcohol/d ) , the equivalent amount of polyphenols in the form of non-alcoholic beer , or gin ( 30 g alcohol/d ) for 4 weeks .\
METHODS	Diet and physical exercise were carefully monitored .\
RESULTS	The number of circulating EPC and EPC-mobilizing factors were determined at baseline and after each intervention .\
RESULTS	After the beer and non-alcoholic beer interventions , the number of circulating EPC significantly increased by 8 and 5 units , respectively , while no significant differences were observed after the gin period .\
RESULTS	In correlation , stromal cell derived factor 1 increased significantly after the non-alcoholic and the beer interventions .\
CONCLUSIONS	The non-alcoholic fraction of beer increases the number of circulating EPC in peripheral blood from high cardiovascular risk subjects .\
BACKGROUND	http://www.controlled-trials.com/ISRCTN95345245 ISRCTN95345245 .\
\
###23685298\
OBJECTIVE	The study sought to evaluate the safety and efficacy of FIREHAWK , a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent ( SES ) for treating patients with single de novo coronary lesions compared with the durable polymer everolimus-eluting stent ( EES ) XIENCE V.\
RESULTS	A total of 458 patients with single de novo native coronary lesions 24 mm in length and a coronary artery 2.25 to 4.0 mm in diameter were enrolled in the TARGET I study , a prospective , randomised , non-inferiority trial .\
RESULTS	The primary endpoint was in-stent late lumen loss ( LLL ) at nine-month follow-up .\
RESULTS	The secondary endpoint , target lesion failure ( TLF ) , was defined as the composite of cardiac death , target vessel myocardial infarction ( TVMI ) , or ischaemia-driven target lesion revascularisation ( iTLR ) .\
RESULTS	Patients were centrally randomised to treatment with either biodegradable polymer SES ( n = 227 ) or durable polymer EES ( n = 231 ) .\
RESULTS	The nine-month in-stent LLL of the biodegradable polymer SES was comparable to the EES group ( 0.13 0.24 mm vs. 0.13 0.18 mm , p = 0.94 ; difference and 95 % confidence interval 0.00 [ -0.04 , 0.04 ] mm ; p for non-inferiority < 0.0001 ) .\
RESULTS	Cardiac death ( 0.4 % vs. 0.0 % ) , TVMI ( 1.3 % vs. 1.7 % ) , iTLR ( 0.4 % vs. 0.4 % ) and TLF ( 2.2 % vs. 2.2 % ) were similar between the biodegradable polymer SES and durable polymer EES groups at 12-month follow-up ( all p > 0.05 ) .\
RESULTS	No definite/probable stent thrombosis was observed in both of these groups .\
CONCLUSIONS	In the multicentre TARGET I trial , the novel abluminal groove-filled biodegradable polymer SES FIREHAWK was non-inferior to the durable polymer EES XIENCE V with respect to the primary endpoint of in-stent LLL at nine months for treating patients with single de novo coronary lesions .\
CONCLUSIONS	The incidences of clinical endpoints were low in both of the stents at 12-month follow-up .\
CONCLUSIONS	( ClinicalTrials.gov identifier : NCT01196819 ) .\
\
###19450044\
OBJECTIVE	This study examines the role of self-reported trait positive affect ( PA ) on skin barrier recovery after skin disruption , and whether the role of trait PA in wound healing is consistent with the direct effects model or the stress-buffering model of PA and health .\
METHODS	Sixty healthy participants ( mean age 22.7 + / - 3.9 years ) completed a self-report measure of trait positive and negative affect , underwent a `` tape-stripping '' procedure that disrupts normal skin barrier function , and were randomly assigned to a Stress ( Trier Social Stress Test ) or No Stress ( reading task ) condition .\
METHODS	Skin barrier recovery was assessed by measuring transepidermal water loss up to 2 hr after skin disruption .\
RESULTS	Multilevel modeling indicated that greater trait PA was related to faster skin barrier recovery ( p < .05 ) .\
RESULTS	The effects of PA on skin barrier recovery were independent of levels of trait NA .\
CONCLUSIONS	These findings suggest that trait PA may influence skin barrier recovery following a brief stressor .\
CONCLUSIONS	In addition , these results provide additional evidence that trait PA can positively impact objective health outcomes .\
\
###24325695\
OBJECTIVE	To investigate the impact of using paclitaxel-coated balloons ( PCB ) on outcome after post-angioplasty dissection in femoropopliteal arteries .\
METHODS	The angiograms obtained in the THUNDER study ( ClinicalTrials.gov identifier NCT00156624 ) were analyzed to compare degrees of dissection and angiographic parameters between the control ( uncoated balloons , n = 43 ) and treatment ( PCBs , n = 43 ) groups before and after the intervention and at 6-month follow-up .\
METHODS	Furthermore , target lesion revascularizations ( TLR ) were documented up to 2 years .\
RESULTS	In each group , 24 ( 56 % ) patients had a dissection after the intervention .\
RESULTS	At the 6-month follow-up , patients with dissection of any grade after treatment with PCBs had significantly less late lumen loss ( 0.4 mm ) than patients with dissection after treatment with uncoated balloons ( 1.9 mm , p = 0.001 ) and a lower degree of stenosis ( 20 % vs. 51 % , respectively ; p = 0.003 ) .\
RESULTS	Patients with severe dissection ( grades C , D , or E ) especially seemed to benefit from the PCBs , with late lumen loss of 0.4 mm vs. 2.4 mm for controls ( p = 0.05 ) .\
RESULTS	The binary restenosis rate was also markedly lower in the PCB group ( 20 % ) than in the uncoated group ( 55 % , p = 0.02 ) .\
RESULTS	In the 2-year follow-up , TLR was performed in 56 % of patients in the control group compared to 10 % of patients in the PCB group ( p = 0.002 ) .\
CONCLUSIONS	The results of this subgroup analysis suggest that patients with dissection following treatment with a paclitaxel-coated balloon have a very acceptable outcome and stent implantation is not necessary as long as the dissection does not result in acute flow limitation .\
\
###21941011\
OBJECTIVE	To compare the effect of inter-set cooling and no cooling during resistance exercise ( RE ) on the total repetitions and select muscle damage biomarker responses .\
METHODS	Sixteen healthy men volunteered to participate in this study and were randomly assigned to Cooling ( n = 8 ) or Control ( n = 8 ) groups .\
METHODS	They performed a RE protocol consisting of four sets of biceps curl at 80 % of 1RM .\
METHODS	The cooling group received the application of wet bags of ice during each interest rest interval ( Cooling ) , while the Control realized the same protocol without ice application .\
METHODS	Exercise was performed to voluntary fatigue and the numbers of repetitions per set were recorded .\
METHODS	Subjects provided blood samples before and at 24 , 48 , and 72 h following RE to evaluate serum CK activity and myoglobin concentration .\
RESULTS	The Cooling group produced a greater number of repetitions ( approx .\
RESULTS	21 % ) than did the Control , but there were no differences in serum CK activity and myoglobin responses between the groups .\
CONCLUSIONS	Incorporating inter-set external cooling augments the number of repetitions per set during RE without inducing an additional muscle damage biomarker response .\
\
###20698216\
OBJECTIVE	Proton pump inhibitor ( PPI ) therapy is considered as the first choice for treatment of non-erosive reflux disease ( NERD ) .\
OBJECTIVE	However , NERD is less sensitive to PPIs than erosive gastroesophageal reflux disease ( GERD ) and the differences between PPIs and H2 receptor antagonists are less evident in NERD than in erosive GERD .\
OBJECTIVE	Since gastric acid secretion is lower in the Japanese population than in Western populations , we aimed to investigate whether PPI therapy is really necessary for NERD patients in Japan .\
METHODS	Thirty-three symptomatic endoscopically diagnosed NERD patients were randomly assigned to receive roxatidine acetate 75 mg twice daily ( n = 16 ) or omeprazole 20 mg once daily ( n = 17 ) .\
METHODS	Gastrointestinal symptoms were assessed using the Gastrointestinal Symptom Rating Scale at baseline and after 4 and 8 weeks of treatment .\
RESULTS	Both roxatidine and omeprazole significantly improved the heartburn score at 4 and 8 weeks .\
RESULTS	The clinical response rates did not differ between roxatidine and omeprazole .\
RESULTS	Both roxatidine and omeprazole significantly relieved not only reflux but also abdominal pain and indigestion .\
RESULTS	The degrees of improvement did not differ between the two groups .\
CONCLUSIONS	Roxatidine relieved the symptoms of NERD patients with similar effectiveness to omeprazole .\
CONCLUSIONS	Therefore , roxatidine may be a good choice for NERD treatment .\
\
###21727105\
OBJECTIVE	The aims of this study were to generate composite measures quantifying a household 's obesogenic potential and to examine the relationship of the composite variables with older children 's eating , physical activity ( PA ) , and small screen recreation .\
METHODS	Data were from surveys with 1685 child-parent pairs in which the child was in grade 6 , 8 , or 10 ( mean age : 14 years ) .\
METHODS	Composite measures of the obesogenic household environment were generated from 11 measures using nonlinear principal components analysis .\
METHODS	Associations between the composite measures and the children 's healthy and unhealthy food intake , PA , and screen time were tested ( adjusting for demographic characteristics ) .\
RESULTS	Two scales were generated : ( 1 ) obesogenic control , which clustered together factors that mitigate risk ; and ( 2 ) obesogenic risk .\
RESULTS	Higher scores on the control scale were associated with higher adolescent intake of healthy foods , lower intake of unhealthy foods , higher PA , and less screen time .\
RESULTS	Higher scores on the risk scale were associated with lower adolescent intake of healthy foods , higher intake of unhealthy foods , lower PA , and more screen time .\
RESULTS	There were significant 2-way interactions between the scales for soft drink consumption and PA. .\
CONCLUSIONS	Household obesogenic potential may be quantified as 2 factors reflecting cumulative risk and control practices .\
CONCLUSIONS	These factors have both additive associations with obesogenic behaviors and , in some cases , modify each other , suggesting that a healthy home environment requires attention to both .\
CONCLUSIONS	Health promotion messages could incorporate these 2 different but interacting factors that parents can use to modify the obesogenic potential of their household .\
\
###24274963\
BACKGROUND	Cognitive Behaviour Therapy ( CBT ) based self-help has been found to be effective for treating depression and anxiety .\
BACKGROUND	There is some evidence to suggest that CBT needs to be culturally adapted for it to be effective in non-Western cultures .\
BACKGROUND	CBT is not widely used in low and middle income countries and there is a need to test its effectiveness in different settings and formats , including self-help .\
METHODS	We describe a RCT of a Culturally adapted CBT ( CaCBT ) based self-help manual in Pakistan .\
METHODS	The trial was conducted in psychiatry departments in three cities .\
METHODS	Assessments were carried out at baseline and at 12 weeks , using Hospital Anxiety and Depression Scale , Bradford somatic Inventory and brief disability Questionnaire .\
RESULTS	At the end of the trial CaCBT based self-help was found to be effective against care as usual in reducing the symptoms of depression and anxiety , as well as somatic symptoms and disability .\
CONCLUSIONS	This study was conducted only in secondary care and required either patient or a carer to be able to read and write .\
CONCLUSIONS	This is the first study outside West of a CBT based self-help intervention for depression .\
CONCLUSIONS	This study highlights the importance of using cost effective interventions in developing world in low intensity formats .\
CONCLUSIONS	Future studies should focus on trying these resources in different settings , like primary care , and with the use of audio/video or multimedia resources to improve compliance in patients with lower literacy .\
\
###25746580\
OBJECTIVE	To evaluate whether anticholinergic medication contributes to early recovery of continence and improvement of other voiding symptoms after radical prostatectomy ( RP ) .\
METHODS	A total of 78 patients with clinically localized prostate cancer who had incontinence at 1 week after RP were enrolled prospectively .\
METHODS	The patients were allocated to one of the 2 groups : group 1 ( - adrenergic agonist [ midodrine ] plus an anticholinergic [ solifenacin ] ) or group 2 ( - adrenergic agonist only ) .\
METHODS	A urodynamic study and the International Continence Society male Short Form questionnaire were completed preoperatively and 4 months after RP .\
METHODS	One-hour pad test and 3-day frequency volume chart at 1 and 4 months after medication were also analyzed .\
RESULTS	The rate of continence , defined as being pad free , did not differ between the groups at 4 months ( both 71.8 % ; P > .05 ) .\
RESULTS	However , the decreased value of mean weight of daily pads worn by groups 1 and 2 were 51.5 vs 11.7 g , respectively ( P = .005 ) .\
RESULTS	The incontinence ( P = .008 ) and quality of life ( P = .044 ) subscale scores significantly worsened in group 2 , whereas they remained unchanged in group 1 .\
RESULTS	Maximal detrusor pressure and maximal urethral closure pressure significantly decreased in both groups , whereas maximal cystometric capacity increased significantly in group 1 only ( 290.8-332 .0 cm H2O ; P < .001 ) .\
CONCLUSIONS	Anticholinergics may facilitate early recovery from incontinence and prevent worsening of quality of life , which might be attributed to increased cystometric capacity after their use .\
\
###10102410\
BACKGROUND	Open clinical trials indicate that low doses of pergolide , a long-acting D1 and D2 dopamine agonist , lead to a reduction in the symptoms of restless legs syndrome ( RLS ) with subjective improvement in sleep quality .\
OBJECTIVE	To assess the therapeutic efficacy of pergolide in improving sleep and subjective measures of well-being in patients with idiopathic RLS using polysomnography and clinical ratings .\
METHODS	In a randomized , double-blind , placebo-controlled crossover design we enrolled 30 patients with idiopathic RLS according to the criteria of the International RLS Study Group .\
METHODS	All patients were free of psychoactive drugs for at least 2 weeks before the study .\
METHODS	Patients were monitored using polysomnography , clinical ratings , and sleep diaries at baseline and at the end of a 4-week pergolide or placebo treatment period .\
METHODS	The initial dosage of 0.05 mg pergolide was increased to the best subjective improvement paralleled by 20 mg domperidone tid .\
RESULTS	At a mean dosage of 0.51 mg pergolide as a single daily dose 2 hours before bedtime , there were fewer periodic leg movements per hour of time in bed ( 5.7 versus 54.9 , p < 0.0001 ) , and total sleep time was significantly longer ( 373 versus 261 minutes , p < 0.0001 ) .\
RESULTS	Ratings of subjective sleep quality , quality of life , and severity of RLS were improved significantly without relevant adverse events .\
CONCLUSIONS	Pergolide given as a single low-to-medium bedtime dose in combination with domperidone provides a well-tolerated and effective treatment of sensorimotor symptoms and sleep disturbances in patients with primary RLS .\
\
###12579927\
OBJECTIVE	To investigate the effects of 0.3 % levofloxacin eyedrops on the treatment of acute bacterial conjunctivitis and bacterial keratitis .\
METHODS	The patients were randomly divided into treated group and control group .\
METHODS	They were given 0.3 % levofloxacin and 0.3 % ofloxacin eyedrops respectively .\
RESULTS	From April to December in 1999 , 132 cases were enrolled in the study .\
RESULTS	It showed that there was no significant difference between two drops in the cure and effective rates , but the mean cure day of keratitis in levofloxacin group was significantly shorter than that in ofloxacin group .\
RESULTS	No serious side effects occurred .\
CONCLUSIONS	Levofloxacin eyedrops was effective and safe antibiotics in treating bacterial conjunctivitis and keratitis .\
\
###21497767\
BACKGROUND	The carnitines exert neuroprotective and neuromodulatory actions , and carnitine supplementation increases locomotor activity ( LMA ) in experimental animals .\
METHODS	We measured 13 indexes of LMA and 3 indexes of stereotypic activity ( STA ) in adult male and female caged mice .\
METHODS	In a randomized 4-week trial , 10 males and 10 females received 50 mg/kg body weight PO l-carnitine , and another 10 males and 10 females received placebo .\
RESULTS	Compared with placebo-treated females , placebo-treated males had a greater number of stereotypies ( NSTs ) , stereotypy counts ( STCs ) , stereotypy time ( STT ) , and right front time ( RFT ) , but smaller total distance traveled ( TDT ) , margin distance ( MD ) , number of vertical movements ( NVMs ) , and left rear time ( LRT ) .\
RESULTS	Compared with placebo-treated males , carnitine-treated males had greater horizontal activity ( HA ) , movement time ( MT ) , NVM , STT , TDT , STC , MD , LRT , and clockwise revolutions ( CRs ) , but smaller left front time ( LFT ) and RFT .\
RESULTS	Compared with placebo-treated females , carnitine-treated females had greater NST , STC , STT , LFT , and RFT , but smaller NM , HA , NVM , VA , MT , anticlockwise revolutions ( ACRs ) , CR , TDT , and MD ; right rear time ( RRT ) remained statistically insignificant across all comparisons .\
CONCLUSIONS	In summary , l-carnitine caused gender differences to persist for STC , diminish for NST and STT , disappear for LRT and NVM , change in the opposite direction for TDT and MD , appear de novo for HA , VA , NM , MT , and LFT , and remain absent for RRT and ACR .\
CONCLUSIONS	Some indexes of LMA and STA are sexually dimorphic in adult mice , and l-carnitine differentially maintains , diminishes/cancels , inverts , or creates the sexual dimorphism of particular indexes .\
\
###18538237\
BACKGROUND	From an evidence-based point of view , correction of posterior crossbite is not sufficiently evaluated .\
BACKGROUND	Thus , the aims of this study were to compare and evaluate the effectiveness of different treatment strategies to correct unilateral posterior crossbite in the mixed dentition by using the randomized clinical trial methodology with an untreated control group .\
METHODS	Sixty patients participated in the study .\
METHODS	All met the following inclusion criteria : mixed dentition , unilateral posterior crossbite , no sucking habits , and no previous orthodontic treatment .\
METHODS	The patients were randomized into 4 groups : quad-helix , expansion plate , composite onlay , and untreated control .\
METHODS	The success rates , amounts of maxillary and mandibular expansion , and treatment times were registered .\
RESULTS	The quad-helix appliance was superior to the expansion plate in success rate and treatment time .\
RESULTS	Treatment with the expansion plate was unsuccessful in one third of the subjects .\
RESULTS	Crossbite correction with composite onlay in the mixed dentition was ineffective , and spontaneous correction in the mixed dentition did not occur .\
CONCLUSIONS	If unilateral posterior crossbite is planned to be corrected in the mixed dentition , this study clearly confirmed that treatment with the quad-helix is an appropriate and successful method .\
\
###23954165\
OBJECTIVE	To study the changes in peak systolic velocities of the ipsilateral external carotid artery ( ECA ) following carotid revascularization .\
METHODS	All patients randomized to carotid artery stenting ( CAS ) or carotid endarterectomy ( CEA ) in the International Carotid Stenting Study ( ICSS ; ISRCTN25337470 ) in our center were included .\
METHODS	Peak systolic velocities ( PSV ) were assessed with duplex ultrasound ( DUS ) at baseline , at 30 days , and at 12 and 24 months after treatment .\
METHODS	Our primary outcome measure was the change in blood flow velocities in the ECA ( PSVECA ) .\
METHODS	Secondary outcome measure was the prevalence of post interventional ECA occlusion .\
RESULTS	Of 270 patients enrolled in ICSS at our center , 224 patients ( mean age , 68.8 years ; 154 males ) were included in the present study ( 116 CAS , 108 CEA ) .\
RESULTS	Baseline PSV in the ipsilateral ECA was similar between the groups .\
RESULTS	Following CAS , PSV gradually increased during follow-up , whereas PSV remained relatively stable after CEA ; mean difference of PSV between CAS and CEA : 23 cm/s ( 95 % CI , -5 to 52 ) , 58 cm/s ( 95 % CI , 27-89 ) , and 69 cm/s ( 95 % CI , 31-107 ) at 30 days , 12 months , and 24 months .\
RESULTS	One new ECA occlusion occurred after CAS and two after CEA .\
CONCLUSIONS	Blood flow velocities in the ipsilateral ECA increase significantly after CAS but not after CEA .\
CONCLUSIONS	However , this does not lead to a higher rate of ECA occlusion in the first 2 years after revascularization .\
CONCLUSIONS	We conclude that CAS is not inferior to CEA in preserving the ECA as a possible potential collateral pathway for cerebral blood supply within 2 years following revascularization .\
\
###7797808\
OBJECTIVE	To determine whether a fat - and energy-reduced diet rich in antioxidant vitamins C and E , beta carotene , and soluble dietary fiber reduces free-radical stress and cardiac enzyme level and increases plasma ascorbic acid level 1 week after acute myocardial infarction .\
METHODS	Randomized , single blind , controlled study .\
METHODS	Primary - and secondary-care research center for patients with myocardial infarction .\
METHODS	All subjects with suspected acute myocardial infarction ( n = 505 ) were considered for entry to the study .\
METHODS	Subjects with definite or possible acute myocardial infarction and unstable angina ( according to World Health Organization criteria ) were assigned to either an intervention diet ( n = 204 ) or a control diet ( n = 202 ) within 48 hours of symptoms of infarction .\
METHODS	Intervention and control groups were advised to consume a fat-reduced , oil-substituted diet .\
METHODS	The intervention group was also advised to eat more fruits , vegetable soup , pulses , and crushed almonds and walnuts mixed with skim milk .\
METHODS	Reduction in plasma lipid peroxide and lactate dehydrogenase cardiac enzyme levels , increase in plasma ascorbic acid level , and compliance with diet , especially with vitamin C intake as determined by chemical analysis .\
METHODS	A two-sample t test using one-way analysis of variance for comparison of data .\
RESULTS	Plasma lipid peroxide level decreased significantly in the intervention group compared with the control group ( 0.59 pmol/L in the intervention group and 0.10 pmol/L in the control group ; 95 % confidence interval of difference = 0.19 to 0.83 ) .\
RESULTS	Lactate dehydrogenase level increased less in the intervention group than in the control group ( 427.7 vs 561.2 U/L ; confidence interval of difference = 82.9 to 184.7 ) .\
RESULTS	Plasma ascorbic acid level increased more in the intervention group than in the control group ( 23.38 vs 7.95 mumol/L ; confidence interval of difference = 12.85 to 26.13 ) .\
CONCLUSIONS	Consumption of an antioxidant-rich diet may reduce the plasma levels of lipid peroxide and cardiac enzyme and increase the plasma level of ascorbic acid .\
CONCLUSIONS	Antioxidant-rich foods may reduce myocardial necrosis and reperfusion injury induced by oxygen free radicals .\
\
###10422931\
BACKGROUND	Intrathecal neostigmine induces analgesia but also several side effects .\
BACKGROUND	Recently , 500 microg neostigmine administered intraarticularly was shown to produce postoperative analgesia without side effects .\
BACKGROUND	The authors ' goal was to determine whether 500 microg neostigmine added to mepivacaine in axillary plexus block prolongs postoperative analgesia .\
BACKGROUND	In addition , they wanted to determine the incidence of side effects in patients undergoing hand surgery .\
METHODS	Sixty-nine outpatients scheduled for carpal tunnel syndrome repair with axillary plexus block were randomly assigned to one of three groups that received saline solution in the axillary plexus and subcutaneously ( group 1 ) , 500 microg neostigmine in the axillary plexus and saline solution subcutaneously ( group 2 ) , or saline solution in the axillary plexus and 500 microg neostigmine subcutaneously ( group 3 ) .\
METHODS	Sensory and motor block in the four hand nerve distributions were assessed every 5 min for 30 min The duration of the sensory and motor blocks were assessed after operation .\
METHODS	Side effects were also recorded .\
RESULTS	Neostigmine had no effect on sensory and motor block in any of the four nerve distributions , nor did it increase the median duration of sensory block ( 215 min ; range , 120-330 min ) compared with group 1 ( 247 min ; range , 190-287 min ) or group 3 ( 236 min ; range , 160-280 min ) .\
RESULTS	Motor block was slightly shorter ( P = 0.045 ) in group 3 ( 190 min ; range , 135-285 min ) compared with group 1 ( 218 min ; range , 145257 min ) and group 2 ( 215 min ; range , 105-343 min ) .\
RESULTS	Gastrointestinal side effects occurred in 30 % of patients in both neostigmine groups but not in group 1 ( P < 0.05 ) .\
CONCLUSIONS	This study suggests that 500 microg neostigmine added to mepivacaine in axillary plexus block does not prolong postoperative sensory block , but it does cause a relatively high incidence of side effects .\
CONCLUSIONS	These two findings raise doubts about the use of neostigmine associated with local anesthetics for plexus neural block .\
\
###15689862\
OBJECTIVE	To compare the Phantom bioabsorbable polymer interference screw ( DePuy , Warsaw , IN ) with a titanium metal interference screw when used in fixation of femoral and tibial bone blocks in central third bone-patellar tendon-bone autograft anterior cruciate ligament ( ACL ) reconstructions .\
METHODS	Multicentered prospective randomized study .\
METHODS	Two surgeons performed primary ACL reconstructions at different locations .\
METHODS	Preoperatively , the patients were randomly assigned .\
METHODS	One group received a titanium cannulated interference screw .\
METHODS	The second group received the cannulated poly-L-lactic bioabsorbable Phantom screw .\
METHODS	Data included subjective evaluation of activity level and International Knee Documentation Committee scores .\
METHODS	Objective measures were made using the KT-1000 arthrometer ( MedMetric , San Diego , CA ) , range of motion , presence of effusions , and complications intraoperatively or postoperatively .\
METHODS	Measurements were made at 1 year and 2 years .\
METHODS	Radiographic evaluation was carried out at least 2 years from the initial surgical date and interpreted by 2 independent orthopaedic surgeons .\
RESULTS	At the 1-year follow-up ( N = 97 ) , pain was reported more during moderate activity in the Phantom screw group ( 6 ) compared with the titanium screw group ( 0 ) ( P = .03 ) .\
RESULTS	No statistical difference between range of motion ( P = .45 ) , activity level ( P = .83 ) , swelling with activity ( P = .95 ) , partial ( P = .13 ) or full ( P = .31 ) giving way , knee effusions ( P = .33 ) , or KT-1000 side-to-side difference ( P = .53 ) were found .\
RESULTS	At the 2-year follow-up ( N = 65 ) , more subjects ( 18 ) in the Phantom interference screw group reported activity levels in the strenuous category compared with those in the titanium interference screws ( 7 ) group ( P = .02 ) .\
RESULTS	No differences were reported with respect to pain ( P = .97 ) , effusion ( P = .17 ) , partial ( P = .28 ) or full ( P = .27 ) giving way , swelling with activity ( P = .21 ) , range of motion ( P = .64 ) , or KT-1000 side-to-side difference ( P = .96 ) .\
RESULTS	Radiographic inspection showed no change in bone plug position , osteolysis , adverse effect , or complication caused by the bioabsorbable material .\
RESULTS	Some evidence of tunnel widening was seen in both groups .\
CONCLUSIONS	Use of a poly-L-lactic bioabsorbable interference screw can provide clinical results equal to that of a metal interference screw for fixation of a central third bone-patellar tendon-bone graft in ACL reconstruction .\
METHODS	Level II , therapeutic .\
\
###10065788\
OBJECTIVE	To examine potential methods for distinguishing between the acrosome reaction and acrosomal loss .\
METHODS	Prospective randomized study .\
METHODS	Department of Obstetrics and Gynecology , Osaka University Hospital , Suita , Japan .\
METHODS	Five healthy volunteers and 34 patients with normozoospermia who were participating in an IVF program .\
METHODS	Semen samples were collected from the volunteers before the hamster egg penetration assay and from the patients at the time of IVF .\
METHODS	The numbers of oocytes penetrated and spermatozoa bound were determined with the hamster egg penetration assay .\
METHODS	Acrosomal status was assessed with two-color fluorescence staining using fluorescein isothiocyanate-conjugated Pisum sativum agglutinin ( FITC-PSA ) and MH61 ( anti-CD46 monoclonal antibody ) with Texas red-conjugated antimouse immunoglobulin G antiserum .\
RESULTS	The MH61 monoclonal antibody inhibited the penetration of human spermatozoa into hamster oocytes but did not reduce the number of spermatozoa bound to the zona-free hamster oocytes .\
RESULTS	Two-color fluorescence staining revealed four staining patterns of the acrosomal region .\
RESULTS	The percentage of PSA-negative/CD46-positive spermatozoa increased to a greater extent than that of PSA-negative/CD46-negative spermatozoa with an increase in the incubation time .\
CONCLUSIONS	Two-color fluorescence staining with FITC-PSA and the anti-CD46 monoclonal antibody may be useful for distinguishing between the acrosome reaction and acrosomal loss .\
\
###24833327\
BACKGROUND	Although high-dose N-acetylcysteine ( NAC ) has been suggested to reduce COPD exacerbations , it is unclear which category of patients with COPD would benefit most from NAC treatment .\
BACKGROUND	The objective of this study was to compare the effect of high-dose NAC ( 600 mg bid ) between high-risk and low-risk Chinese patients with COPD .\
METHODS	Patients with spirometry-confirmed stable COPD were randomized to treatment with either NAC 600 mg bid or placebo in addition to their usual treatments .\
METHODS	Patients were followed up every 16 weeks for a total of 1 year .\
METHODS	Further analysis was performed according to each patient 's exacerbation risk at baseline as defined by the current GOLD ( Global Initiative for Chronic Obstructive Lung Disease ) strategy to analyze the effect of high-dose NAC in high-risk and low-risk patients .\
RESULTS	Of the 120 patients with COPD randomized ( men , 93.2 % ; mean age , 70.8 0.74 years ; prebronchodilator FEV , 53.9 2.0 % ; baseline characteristics comparable between treatment groups ) , 108 ( NAC , 52 ; placebo , 56 ) completed the 1-year study .\
RESULTS	For high-risk patients ( n = 89 ) , high-dose NAC compared with placebo significantly reduced exacerbation frequency ( 0.85 vs 1.59 [ P = .019 ] and 1.08 vs 2.22 [ P = .04 ] at 8 and 12 months , respectively ) , prolonged time to first exacerbation ( P = .02 ) , and increased the probability of being exacerbation free at 1 year ( 51.3 % vs 24.4 % , P = .013 ) .\
RESULTS	This beneficial effect of high-dose NAC vs placebo was not significant in low-risk patients .\
CONCLUSIONS	High-dose NAC ( 600 mg bid ) for 1 year reduces exacerbations and prolongs time to first exacerbation in high-risk but not in low-risk Chinese patients with COPD .\
BACKGROUND	ClinicalTrials.gov ; No. : NCT01136239 ; URL : www.clinicaltrials.gov .\
\
###16089138\
OBJECTIVE	To investigate the effect of fuzheng quxie granule ( FQG ) on immune cells and cytokines in populations with respiratory viral infection .\
METHODS	Fifty-nine patients were randomly divided into 3 groups , that is , 19 patients treated with conventional western medicine ( WM ) plus FQG in the treated group , 19 patients treated with conventional western medicine alone in the WM group , and 21 patients treated with FQG alone in the TCM group .\
METHODS	The levels of T lymphocyte subsets , interleukine-2 ,4,6,10 ( IL-2 , IL-4 , IL-6 , IL-10 ) , tumor necrosis factor-alpha ( TNF-alpha ) , interferon-gamma ( INF-gamma ) and Th1/Th2 were determined before treatment , and at the end of 1st and 2nd week of treatment respectively .\
RESULTS	Before treatment , levels of TNF-alpha , IL-2 , IL-6 , IL-10 and INF-gamma in all patients were significantly higher than normal range ( P < 0.05 ) .\
RESULTS	After being treated for 1 week , the levels of serum TNF-alpha , IL-6 , and IL-10 were significantly decreased in all groups ( P < 0.05 ) , serum IL-2 and INF-gamma decreased to the normal level in the WM group , but in the treated and the FQG group by the end of the 2nd week , the two indexes still remained at the rather higher level ( P < 0.05 ) .\
RESULTS	The ratio of Th1 and Th2 in the treated group and the FQG group increased significantly by the end of 2nd week , reached the level higher than that in the WM group and that before treatment ( P < 0.05 ) .\
RESULTS	No significant difference in , T lymphocytes subsets ( CD3 + , CD4 + , CD8 + ) and percentage of B and NK cells before and after treatment was found in all the 3 groups .\
CONCLUSIONS	FQG can positively regulate the immune function of patients with respiratory tract viral infection in certain degree .\
\
###8231041\
BACKGROUND	A prospective randomized study was carried out to investigate whether intraocular lenses with and without laser ridge have different effects on the development of secondary cataract .\
METHODS	An extracapsular cataract extraction with implantation of a posterior chamber lens was carried out in the period from November 1986 to March 1987 in 100 patients ( 100 eyes ) .\
METHODS	The first group of 50 patients ( 50 eyes ) received a convex-plane ( plano-posterior ) intraocular lens ( IOL ) with a continuous 360 degrees-laser ridge .\
METHODS	The second group of 50 patients ( 50 eyes ) received a convex-plane ( plano-posterior ) IOL without laser ridge .\
METHODS	The follow-up investigations were carried out after 10 days , 2 months , 6 months and 1 , 2 , 3 , 4 and 5 years .\
METHODS	Parameters such as the state of intraocular irritation , the intraocular pressure and astigmatism were also registered during the first six months after the operation .\
METHODS	Attention was paid to the opacity of the posterior capsule and the deterioration in visual acuity associated with this in the subsequent investigations 1 , 2 , 3 , 4 and 5 years after the operation .\
METHODS	All cases with a deterioration of vision by two lines caused by an opacity of the posterior capsule were evaluated as secondary cataract .\
RESULTS	On the basis of this classification , the rate of secondary cataract in the IOL group without laser ridge was 18.5 % , as compared to 19.2 % in the IOL group with laser ridge .\
CONCLUSIONS	After 5 years there is no statistical significant difference between the two groups ( Fishers-Exact-Test , p = 0.999 ) .\
\
###21968012\
OBJECTIVE	The aim of this study was to compare the effect of pentoxifylline versus placebo on serum concentrations of tumor necrosis factor-alpha ( TNF - ) , interleukin 6 ( IL-6 ) and C-reactive protein ( CRP ) of hemodialysis ( HD ) patients .\
METHODS	This is a randomized double-blind , controlled clinical trial .\
METHODS	HD patients without infection or drugs with anti-inflammatory effect were randomly allocated to a study ( n = 18 , pentoxifylline 400 mg/day ) or control ( n = 18 , placebo ) group ; all patients had arteriovenous fistula .\
METHODS	Besides clinical and laboratory monthly assessments , serum TNF - and IL-6 ( ELISA ) and CRP ( nephelometry ) were measured at 0 , 2 and 4 months .\
RESULTS	All the inflammation markers significantly ( P < 0.05 ) decreased in the pentoxifylline group : TNF - [ baseline 0.4 ( 0-2 ) versus final 0 ( 0-0 ) pg/mL ] , IL-6 [ baseline 9.4 ( 5-14 ) versus final 2.9 ( 2-5 ) pg/mL ] and CRP [ baseline 7.1 ( 3-20 ) versus final 2.6 ( 1-8 ) mg/L ] , whereas no significant changes were observed in the placebo group : TNF - [ baseline 0 ( 0-0 ) versus final 1.2 ( 0-4 ) pg/mL ] , IL-6 [ baseline 8.0 ( 5-11 ) versus final 8.7 ( 4-11 ) pg/mL ] and CRP [ baseline 4.5 ( 2-9 ) versus final 3.8 ( 3-23 ) mg/L ] .\
CONCLUSIONS	Pentoxifylline significantly decreased serum concentrations of TNF - , IL-6 and CRP compared to placebo .\
CONCLUSIONS	Pentoxifylline could be a promising and useful strategy to reduce the systemic inflammation frequently observed in patients on HD .\
\
###11869407\
OBJECTIVE	To determine the effect of a partially hydrolysed formula on genetically predisposed children , with respect to the development of atopic clinical manifestations and in vitro testing of serum IgE levels ( total and milk-specific ) .\
METHODS	One hundred and ten infants were randomly assigned to receive either partially hydrolysed formula or standard infant formula , and were prospectively monitored from birth for clinical atopic symptoms and serum IgE levels .\
RESULTS	Eczema occurred less frequently in infants receiving partially hydrolysed formula .\
RESULTS	This was significant ( P < 0.05 ) at 3 , 6 , 9 , 12 , 18 and 24 months .\
RESULTS	However , the significance decreased with time , although it almost reached statistical significance at 30 months by the Kaplan-Meier survival function ( log-rank statistic , 3.46 ; P = 0.063 ) .\
RESULTS	Although wheezing occurred less frequently in infants receiving partially hydrolysed formula , compared to those receiving standard infant formula , the difference did not reach statistical significance ( P > 0.05 ) .\
CONCLUSIONS	Exclusive feeding of hypoallergenic milk formula in the first 4 months of life has a protective effect in terms of the development of atopic dermatitis in the first 2 years of life , compared to feeding with cow 's milk formula .\
\
###16620590\
OBJECTIVE	To evaluate the long-term efficacy of revaccination in non-responder children to primary hepatitis B ( HB ) vaccination and to compare the efficacy of low-dose intradermal inoculation to that of routine-dose intramuscular inoculation .\
METHODS	40 healthy non-responder children to primary HB vaccination identified by screening were given a three-dose revaccination randomly by intramuscular ( n = 17 , 10 microg per dose ) or intradermal route ( n = 23 , 2 microg per dose ) since September , 1999 , and their blood specimens were collected regularly for testing for HB virus markers up to five years .\
METHODS	Another 80 responder children to primary HB vaccination were also followed-up as controls without revaccination .\
METHODS	By the end of five-year follow-up , HBsAg-specific lymphocyte response was investigated in vitro , and a booster dose ( 5 microg ) was given to those with negative conversion of anti-HBs and their anamnestic responses were evaluated 12-14 days later .\
RESULTS	Serum anti-HBs did not reach 10 IU/L only in one of 40 non-responder children , who received intradermal revaccination .\
RESULTS	In the fifth year after revaccination , 50 % of the non-responder children who received intramuscular revaccination still maintained anti-HBs of > or = 10 IU/L , though the rate was significantly lower than 85 % in controls .\
RESULTS	Following the booster dose , a robust anamnestic response was developed in all of 8 intramuscular revaccinees and 11 controls but 16 of 18 intradermal revaccinees , who lost anti-HBs of > or = 10 IU/L over time , and geometric mean titers of anti-HBs climbed to 208 , 105 , and 549 IU/L , respectively .\
RESULTS	Secretions of HBsAg-specific interleukin-2 and -5 could be detected in peripheral blood mononuclear cell samples of more than 70 % of non-responder children .\
RESULTS	Person-year infection rates of HB virus were 8.9 % ( 8/89 .9 person-years ) for intradermal revaccinees , significantly higher than 3.6 % ( 12/337 .2 person-years ) in controls , and 4.3 % ( 3/70 .2 person-years ) for intramuscular revaccinees , approximating to that of controls , based on positive conversion of anti-HBc .\
CONCLUSIONS	Three-dose intramuscular revaccination did play an important immune protection for non-responder children to primary HB vaccination , but its efficacy could not reach the level of primary vaccination in responders .\
CONCLUSIONS	Low-dose intradermal inoculation was not as effective as route-dose intramuscular inoculation with the same doses in revaccination for non-responder children to primary HB vaccination .\
\
###23159435\
BACKGROUND	No previous study investigated statin action on monocyte cytokine release and systemic inflammation in patients with isolated hypertriglyceridemia .\
METHODS	Our study included 43 subjects with isolated hypertriglyceridemia and peripheral artery stenosis randomly allocated to one of two groups , treated for 12 weeks with either simvastatin ( 40 mg twice daily ) or placebo .\
METHODS	Plasma lipids , glucose homeostasis markers , plasma C-reactive protein and monocyte cytokine release were determined on the day of allocation and at the end of the treatment period .\
RESULTS	Simvastatin , but not placebo , reduced monocyte release of tumor necrosis factor - , interleukin-6 , interleukin-1 and monocyte chemoattractant protein-1 , as well decreased plasma levels of C-reactive protein .\
CONCLUSIONS	Our study shows that simvastatin reduces monocyte secretory function and has systemic anti-inflammatory properties in patients with isolated hypertriglyceridemia .\
\
###8780431\
OBJECTIVE	Earlier studies reported that inositol , a simple polyol second messenger precursor , was effective in controlled trials for patients with depression and panic .\
OBJECTIVE	In this study its effectiveness in obsessive-compulsive disorder was investigated .\
METHODS	Thirteen patients with obsessive-compulsive disorder completed a double-blind , controlled crossover trial of 18 g/day of inositol or placebo for 6 weeks each .\
RESULTS	The subjects had significantly lower scores on the Yale-Brown Obsessive Compulsive Scale when taking inositol than when taking placebo .\
CONCLUSIONS	The authors conclude that inositol is effective in depression , panic , and obsessive-compulsive disorder , a spectrum of disorders responsive to selective serotonin reuptake inhibitors .\
\
###15453912\
BACKGROUND	Complex Regional Pain Syndrome type one ( CRPS I ) or formerly Reflex Sympathetic Dystrophy ( RSD ) is a disabling syndrome , in which a painful limb is accompanied by varying symptoms .\
BACKGROUND	Neuropathic pain is a prominent feature of CRPS I , and is often refractory to treatment .\
BACKGROUND	Since gabapentin is an anticonvulsant with a proven analgesic effect in various neuropathic pain syndromes , we sought to study the efficacy of the anticonvulsant gabapentin as treatment for pain in patients with CRPS I.\
METHODS	We did a randomized double blind placebo controlled crossover study with two three-weeks treatment periods with gabapentin and placebo separated by a two-weeks washout period .\
METHODS	Patients started at random with gabapentin or placebo , which was administered in identical capsules three times daily .\
METHODS	We included 58 patients with CRPS type 1 .\
RESULTS	Patients reported significant pain relief in favor of gabapentin in the first period .\
RESULTS	Therapy effect in the second period was less ; finally resulting in no significant effect combining results of both periods .\
RESULTS	The CRPS patients had sensory deficits at baseline .\
RESULTS	We found that this sensory deficit was significantly reversed in gabapentin users in comparison to placebo users .\
CONCLUSIONS	Gabapentin had a mild effect on pain in CRPS I.\
CONCLUSIONS	It significantly reduced the sensory deficit in the affected limb .\
CONCLUSIONS	A subpopulation of CRPS patients may benefit from gabapentin .\
\
###14661000\
BACKGROUND	Pacing leads with a small electrode surface for high-impedance stimulation have been shown to prolong pacemaker longevity , but no sufficient data is available on the safety and feasibility of a defibrillation lead with this novel design .\
METHODS	We evaluated the clinical performance of a tined , steroid-eluting defibrillation lead with a small electrode surface area ( model 6944 ) in a prospective multicenter study .\
METHODS	A total of 542 patients with conventional indications for an implantable cardioverter defibrillator were randomized 1:1 to receive either the model 6944 or a tined , steroid-eluting defibrillation lead with a conventional sized electrode surface area ( model 6942 ) .\
METHODS	Device performance and electrical parameters were evaluated at implant and 1 , 3 , 6 , and 12 months thereafter ( mean follow-up 11.3 + / - 5.6 months ) .\
RESULTS	Baseline characteristics , lead implant success rates , and defibrillation thresholds did not differ significantly between the 2 groups .\
RESULTS	While pacing thresholds did not differ significantly during follow-up , pacing impedance was approximately twice as high in the model 6944 as in the model 6942 lead ( P < .0001 ) .\
RESULTS	Mean R-wave amplitudes were smaller in patients with a 6944 ( 9.1 + / - 3.1 mV vs 9.8 + / - 3.6 mV for model 6942 , P < .05 ) , but remained stable within both groups throughout the observation period .\
RESULTS	The total number of ventricular lead-related adverse events and patient survival did not differ significantly between the 2 groups .\
CONCLUSIONS	The use of a defibrillation lead with a small electrode surface for high-efficiency pacing is safe and feasible and increases pacing impedance without significantly compromising clinical performance .\
\
###18673081\
OBJECTIVE	To compare neonatal neurological morbidity associated with uterine rupture with morbidity associated with a non-reassuring fetal status .\
METHODS	We conducted a retrospective cohort analysis .\
METHODS	Twenty-one cases of term infants delivered after a symptomatic uterine rupture were analyzed and compared with a randomly selected group of 63 infants born after a non-reassuring fetal heart rate pattern .\
RESULTS	Prevalence of uterine rupture was 0.058 % .\
RESULTS	Maternal factors and infant general data were similar in both groups .\
RESULTS	Infants delivered after a uterine rupture had lower Apgar scores at 1 and 5 min , lower umbilical blood pH , and required more advanced resuscitation than infants delivered after a non-reassuring fetal status .\
RESULTS	Prevalence of hypoxic-ischemic encephalopathy in the uterine rupture group was 33 % , compared with 5 % in the other group ( P < 0.01 , relative risk 3.7 ) .\
RESULTS	Four infants in the uterine rupture group ( 19 % ) had moderate or severe encephalopathy ; all of them had also multisystem dysfunction and an adverse outcome .\
RESULTS	No infant in the non-reassuring fetal status group showed moderate or severe encephalopathy .\
CONCLUSIONS	Uterine rupture is a considerable sentinel event that involves a high rate of early and late neurological morbidity in the newborn infant .\
\
###24732630\
BACKGROUND	We ( i ) described variability in colorectal cancer ( CRC ) test use across multiple levels , including physician , clinic , and neighborhood ; and ( ii ) compared the performance of novel cross-classified models versus traditional hierarchical models .\
METHODS	We examined multilevel variation in CRC test use among patients not up-to-date with screening in a large , urban safety net health system ( 2011-2012 ) .\
METHODS	Outcomes included : ( i ) fecal occult blood test ( FOBT ) or ( ii ) colonoscopy and were ascertained using claims data during a 1-year follow-up .\
METHODS	We compared Bayesian ( i ) cross-classified four-level logistic models nesting patients within separate , nonoverlapping `` levels '' ( physicians , clinics , and census tracts ) versus ( ii ) three hierarchical two-level models using deviance information criterion .\
METHODS	Models were adjusted for covariates ( patient sociodemographic factors , driving time to clinic , and census tract poverty rate ) .\
RESULTS	Of 3,195 patients , 157 ( 4.9 % ) completed FOBT and 292 ( 9.1 % ) completed colonoscopy during the study year .\
RESULTS	Patients attended 19 clinics , saw 177 physicians , and resided in 332 census tracts .\
RESULTS	Significant variability was observed across all levels in both hierarchical and cross-classified models that was unexplained by measured covariates .\
RESULTS	For colonoscopy , variance was similar across all levels .\
RESULTS	For FOBT , physicians , followed by clinics , demonstrated the largest variability .\
RESULTS	Model fit using cross-classified models was superior or similar to 2-level hierarchical models .\
CONCLUSIONS	Significant and substantial variability was observed across neighborhood , physician , and clinic levels in CRC test use , suggesting the importance of factors at each of these levels on CRC testing .\
CONCLUSIONS	Future multilevel research and intervention should consider the simultaneous influences of multiple levels , including clinic , physician , and neighborhood .\
\
###20657084\
OBJECTIVE	Bone grafting is the most common form of regenerative therapy .\
OBJECTIVE	Several bone substitutes have been used in clinical periodontal therapy to encourage bone formation .\
OBJECTIVE	The present study has been undertaken to evaluate the efficacy of hard tissue replacement polymer ( Bioplant HTR ) as a bone graft material in the treatment of interproximal vertical bony defects in human beings , both clinically and radiologically .\
METHODS	Five chronic periodontitis patients were selected with 16 sites assigned randomly into control ( open debridement alone ) and experimental ( open flap debridement plus Bioplant HTR ) groups .\
METHODS	Clinical measurements like plaque index ( PI ) , gingival index ( GI ) , probing pocket depth ( PPD ) , clinical attachment level ( CAL ) , gingival margin position ( GMP ) assessment was done at 0 , 3 and 6 months and radiographic assessment at 0 and 6 month .\
METHODS	Statistical analysis was performed using Wilcoxon 's signed Rank test and Mann-whitney U-test .\
RESULTS	There were statistically no significant ( P = 1.00 ) changes in Plaque index and Gingival Index scores in both the groups from baseline to six months post surgery .\
RESULTS	Statistically significant ( P < 0.05 ) reduction in Probing Pocket Depth was seen on comparison between the groups .\
RESULTS	In relation to the hard tissue changes , significant results were seen with respect to change in alveolar crest and percentage of original defect resolved .\
RESULTS	Comparison of results from six to 12 months following similar treatments showed no significant differences or advantages to having a clinical evaluation period longer than 6 months post surgically ( Yukna 1999 ) .\
CONCLUSIONS	Bioplant HTR material is a biocompatible , easy to handle and a beneficial grafting material for the treatment of periodontal osseous defects .\
\
###16301700\
BACKGROUND	Symptomatic remission is the optimal outcome in depression .\
BACKGROUND	A brief , validated tool for symptom measurement that can indicate when remission has occurred in mental health and primary care settings is unavailable .\
BACKGROUND	We evaluated a 7-item abbreviated version ( HAMD-7 ) of the 17-item Hamilton Depression Rating Scale ( HAMD-17 ) in a randomized controlled clinical trial of patients with major depressive disorder being cared for in primary care settings .\
METHODS	We enrolled 454 patients across 47 primary care settings who met DSM-IV-TR criteria for a major depressive disorder .\
METHODS	Of these , 410 patients requiring antidepressant medication were randomized to have their symptoms rated with either HAMD-7 ( n = 205 ) or HAMD-17 ( n = 205 ) as the primary measurement tool .\
METHODS	The primary outcome was the proportion of patients who achieved a-priori defined responses to 8 weeks of therapy using each instrument .\
RESULTS	Of the 205 participants per group , 67 % of those evaluated with HAMD-7 were classified as having responded to therapy ( defined as a > or = 50 % reduction from the pretreatment score ) , compared with 74 % of those evaluated with HAMD-17 ( p = 0.43 ) .\
RESULTS	The difference between the groups ' changes in scores from baseline ( pretreatment ) to endpoint was significant ( p < 0.001 ) , without a main effect of group ( p = 0.84 ) or group-by-time ( p = 0.83 ) interaction .\
RESULTS	The HAMD-7 test was brief to administer ( e.g. , 3-4 min for 85 % of the primary care physicians evaluated ) , which facilitated the efficient and structured evaluation of salient depressive symptoms .\
CONCLUSIONS	The abbreviated HAMD-7 depression scale is equivalent to the HAMD-17 in assessing remission in patients with a major depressive disorder undergoing drug therapy .\
\
###18034195\
OBJECTIVE	We performed a study of laser panretinal photocoagulation in 20 patients with proliferative retinopathy .\
OBJECTIVE	We compared short exposure , high-energy laser settings with conventional settings , using a 532 nm , frequency doubled , Neodymium-Yag laser and assessed the patients in terms of pain experienced and effectiveness of treatment .\
METHODS	Twenty patients having panretinal photocoagulation for the first time underwent random allocation to treatment of the superior and inferior hemi-retina .\
METHODS	Treatment A used ` conventional ' parameters : exposure time 0.1 s , power sufficient to produce a visible grey-white burns , spot size 300 microm .\
METHODS	The other hemi - retina was treated with treatment B using exposure 0.02 s , 300 microm and sufficient power to have similar endpoint .\
METHODS	All patients were asked to evaluate severity of pain on a visual analogue scale .\
METHODS	( 0 = no pain , 10 = most severe pain ) .\
METHODS	All patients were masked as to the type of treatment and the order of carrying out the treatment on each patient was randomised .\
METHODS	Patients underwent fundus photography and were followed up for 6-45 months .\
RESULTS	Seventeen patients had proliferative diabetic retinopathy , two had ischaemic central retinal vein occlusion and one had ocular ischaemic syndrome .\
RESULTS	The mean response to treatment A was 5.11 , compared to 1.40 treatment B , on the visual analogue scale , which was statistically significant ( P = 0.001 ) .\
RESULTS	All patients preferred treatment B. Further treatments , if required , were performed with treatment B parameters and long-term follow-up has shown no evidence of undertreatment .\
CONCLUSIONS	Shortening exposure time of retinal laser is significantly less painful but equally effective as conventional parameters .\
\
###21344827\
OBJECTIVE	To compare the safety and efficacy of a novel sonic power toothbrush and a manual toothbrush in the reduction of gingivitis and plaque over a 4-week period .\
METHODS	This study employed a randomized two treatment , examiner-blinded , parallel group design .\
METHODS	Subjects with evidence of gingivitis were randomly assigned to 4 weeks ' twice daily home use of either the Oral-B Pulsonic sonic toothbrush or an ADA reference manual toothbrush .\
METHODS	At baseline ( Visit 1 ) and again after product use at Week 4 , subjects received gingivitis evaluations with the Modified Gingival Index ( MGI ) and Gingival Bleeding Index ( GBI ) examinations , followed by plaque assessment using the Rustogi Modified Navy Plaque Index ( RMNPI ) .\
METHODS	For 12 hours before both visits , subjects abstained from all oral hygiene , and ceased eating , drinking and smoking 4 hours prior .\
RESULTS	Both brushes significantly reduced gingivitis , gingival bleeding and plaque compared with baseline , and were well-tolerated by the 129 subjects completing the study .\
RESULTS	The sonic toothbrush was statistically significantly ( P < 0.0001 ) more effective than the manual brush , with greater relative mean reductions in MGI , GBI and RMNPI of 11.9 % , 62.3 % and 46.5 % , respectively .\
\
###24922355\
OBJECTIVE	The aim of this study was to evaluate the combination of endoscopic ultrasonography ( EUS ) and computed tomography ( CT ) in predicting the maneuvers for therapeutic endoscopy for gastrointestinal submucosal tumors ( SMTs ) .\
METHODS	Patients with SMTs , who were scheduled for endoscopic resection , were randomized to preoperative performance of both EUS and CT ( group A ) or EUS only ( group B ) .\
METHODS	The following data were collected : therapeutic maneuvers , duration of procedure , dose of propofol , resected lesion size , and complications .\
RESULTS	A total of 36 patients were included in group A and 36 patients were included in group B. Endoscopic submucosal excavation was performed in 43 patients , endoscopic full-thickness resection in 18 patients , and submucosal tunneling endoscopic resection in 11 patients .\
RESULTS	No significant differences were observed between the two groups ( P > 0.05 ) .\
RESULTS	The coincidence rate between the preoperative program and the actual endoscopic procedures in group A was higher than that in group B ( 83.3 vs. 61.1 % , P < 0.05 ) .\
RESULTS	The procedural time in group A was less than that in group B ( 39.3617.83 vs. 48.0612.03 min , P < 0.05 ) , and the dose of propofol in group A was less than that in group B ( 249.18125.12 vs. 304.16102.61 mg , P < 0.05 ) .\
RESULTS	The mean resected lesion size was 2.321.46 cm in group A and 2.120.75 cm in group B , without differences ( P > 0.05 ) .\
RESULTS	A total of 14 cardiopulmonary complications and seven endoscopic complications occurred , without significant differences between the two groups ( P > 0.05 ) .\
CONCLUSIONS	EUS combined with CT can better evaluate SMTs compared with EUS only in predicting the maneuvers for therapeutic endoscopy .\
\
###8618581\
BACKGROUND	The value of autologous bone marrow transplantation in the treatment of children with acute myeloid leukemia ( AML ) is unknown .\
BACKGROUND	We compared autologous bone marrow transplantation with intensive consolidation chemotherapy as treatments for children with AML in first remission .\
METHODS	We induced remission with one course of daunorubicin , cytarabine , and thioguanine , followed by one course of high-dose cytarabine ( 3 g per square meter of body-surface area for six doses ) .\
METHODS	Patients in remission after the second course of induction therapy were eligible for randomization .\
METHODS	Between June 1988 and March 1993 , 552 of 649 enrolled patients who could be evaluated ( 85 percent ) entered remission .\
METHODS	A total of 209 patients were not eligible for randomization ; of the remaining 343 patients , 232 were randomly assigned to receive six courses of intensive chemotherapy ( 117 patients ) or autologous transplantation ( 115 patients ) .\
METHODS	Of the original 649 patients , 189 , including 21 with Down 's syndrome , were nonrandomly assigned to receive intensive chemotherapy .\
RESULTS	The rates of event-free survival and overall survival for the entire group at three years were 34 + / - 2.5 percent and 42 + / - 2.6 percent , respectively .\
RESULTS	For patients who were randomly assigned to one of the two treatment groups , the mean ( + / - SE ) rates of event-free survival three years after randomization were not significantly different in the two groups when examined by intention-to-treat analysis : 36 + / - 5.8 percent for the intensive-chemotherapy group as compared with 38 + / - 6.4 percent for the autologous-transplantation group ; and the relative risk of treatment failure for the chemotherapy group as compared with the autologous-transplantation group was 0.81 ( P = 0.20 by the log rank test ; 95 percent confidence interval , 0.58 to 1.12 ) .\
RESULTS	Overall survival at three years followed a similar pattern .\
RESULTS	There was a lower relapse rate ( 31 percent vs. 58 percent , P < 0.001 ) but a higher rate of treatment-related mortality ( 15 percent vs. 2.7 percent , P = 0.005 ) in the group treated with autologous transplantation than in the intensive-chemotherapy group .\
RESULTS	The event-free survival at three years for the nonrandomized intensive-chemotherapy group was 39 + / - 5.1 percent , and for a contemporaneous group of patients each of whom received a histocompatible bone marrow transplant from a sibling , it was 52 + / - 8.0 percent .\
CONCLUSIONS	Treatment of children with AML in first remission with either autologous bone marrow transplantation or intensive chemotherapy prolongs event-free survival equally .\
\
###22522141\
BACKGROUND	Spontaneous bacterial peritonitis ( SBP ) may occur despite antibiotic prophylaxis .\
BACKGROUND	We investigated whether the addition of probiotics to norfloxacin enhances its efficacy in the prevention of SBP .\
METHODS	A double-blind , randomized-controlled trial was conducted among consecutive cirrhotic patients who had either recovered from SBP ( secondary prophylaxis ) or who were at a high risk for the development of SBP ( low ascitic fluid protein or serum bilirubin 2.5 mg/dl ; primary prophylaxis ) .\
METHODS	Norfloxacin 400 mg/day with probiotics capsules ( Enterococcus faecalis JPC 30 million , Clostridium butyricum 2 million , Bacillus mesentericus JPC 1 million , Bacillus coagulans 50 million spores ) at a dose of two capsules three times daily ( group 1 ) or norfloxacin with a placebo ( group 2 ) was given and the occurrence of SBP within a period of 6 months ( primary endpoint ) or side-effects of therapy and mortality ( secondary endpoints ) were recorded .\
RESULTS	From April 2005 through August 2007 , 110 patients were randomized to group 1 ( n = 55 ) or group 2 ( n = 55 ) and 45 ( 82 % ) and 43 ( 78 % ) of them completed the trial , respectively .\
RESULTS	The baseline characteristics were comparable .\
RESULTS	On intention-to-treat analysis , the cumulative probability of treatment failures was similar in both the groups [ 19/55 ( 34 % ) in group 1 vs. 20/55 ( 36 % ) in group 2 , P = 0.840 ] .\
RESULTS	The cumulative probability of mortality was also similar [ 13/45 ( 29 % ) in group 1 vs. 14/43 ( 32 % ) in group 2 , P = 0.834 ] .\
RESULTS	The frequency of side-effects was also comparable .\
RESULTS	In subgroup analyses , the frequencies of SBP and deaths were similar in the two groups in the subgroups of primary and secondary prophylaxes .\
RESULTS	The presence of encephalopathy and serum bilirubin of greater than 3.65 mg/dl were found to predict mortality independently .\
CONCLUSIONS	The addition of probiotics to norfloxacin does not improve its efficacy in primary or secondary prophylaxis of SBP or in reducing the mortality in cirrhotic patients with ascites .\
\
###8038351\
BACKGROUND	High-dose once daily oral omeprazole dosing can inhibit acid secretion almost completely but several days elapse before maximum efficacy is established .\
BACKGROUND	The acid inhibitory effect obtained with high doses of a histamine H2-receptor antagonist is built up rapidly but has the tendency to fade -- the term ` tolerance ' has been applied to characterize this phenomenon .\
METHODS	To obtain more information on the dynamics of acid inhibition during prolonged dosing , we compared the acid suppressory effects of oral high-dose omeprazole with high-dose ranitidine .\
METHODS	Twenty-eight healthy volunteers were randomly assigned to a 2-week dosing with omeprazole or ranitidine in a double-blind , double-dummy , parallel-group study design .\
METHODS	Omeprazole was given as 1 capsule of 40 mg mane and ranitidine as 2 tabs of 150 mg q.d.s.\
METHODS	The median 24-h pH , daytime pH and night-time pH were measured by ambulatory continuous 24-h pH metry on days -8 , -6 , 1 , 2 , 7 and 14 .\
RESULTS	High reproducibility was observed for the two baseline acidity measurements .\
RESULTS	Ranitidine exerted its peak acid suppressant effect on day 1 of dosing ; the degree of acid inhibition faded from day 2 to 7 , with no significant change thereafter .\
RESULTS	The decline in antisecretory activity was more pronounced during the day than the night .\
RESULTS	In contrast , acid inhibition by omeprazole increased throughout the first week , and antisecretory activity was stable thereafter .\
RESULTS	Despite the considerable differences in median intragastric pH values at the end of the 14-day study , plasma gastrin levels were elevated to a similar degree with both medications .\
CONCLUSIONS	This study confirms the ` tolerance ' phenomenon previously observed with high-dose histamine H2-receptor antagonist dosing .\
CONCLUSIONS	The dynamics with which it occurs exclude a typical exaggerated first-dose response .\
CONCLUSIONS	Prolonged high-dose histamine H2-receptor dosing compromises the feedback mechanism regulating gastrin release , whilst this is maintained during dosing with omeprazole .\
\
###18645140\
OBJECTIVE	To provide an accurate description and to evaluate the incidence and severity of cutaneous reactions induced by sorafenib tosylate , a new oral multikinase inhibitor .\
METHODS	Double-blind , prospective dermatologic substudy performed on all consecutive patients included in our center in a large phase 3 trial .\
METHODS	Institutional practice at the Gustave Roussy Institute .\
METHODS	Eighty-five patients with renal cell cancer treated between November 1 , 2003 , and February 28 , 2005 .\
METHODS	Interventions Patients were randomized to receive either sorafenib ( n = 43 ) or placebo ( n = 42 ) .\
METHODS	Dermatologic examination was performed before treatment , every 3 weeks during the first 4 cycles , and every 4 weeks thereafter .\
METHODS	Incidence and severity of cutaneous reactions to sorafenib .\
RESULTS	Thirty-nine patients ( 91 % ) experienced at least 1 cutaneous reaction in the sorafenib group vs 3 ( 7 % ) in the placebo group .\
RESULTS	A hand-foot skin reaction that appeared to be clinically distinct from the well-known chemotherapy-induced hand-foot syndrome was observed in 26 patients receiving sorafenib ( 60 % ) .\
RESULTS	Reversible grade 3 hand-foot skin reaction was documented in 2 patients receiving sorafenib and led to a dose reduction .\
RESULTS	Other cutaneous reactions were facial erythema , scalp dysesthesia , alopecia , and subungual splinter hemorrhages .\
CONCLUSIONS	Sorafenib induces frequent cutaneous adverse events , some of which may lead to a dose reduction .\
CONCLUSIONS	Close collaboration between oncologists and dermatologists is needed to improve both the characterization and the management of these side effects .\
CONCLUSIONS	Appropriate patient education before the initiation of therapy and the introduction of early symptomatic measures may improve management .\
\
###16564210\
OBJECTIVE	Interventions to improve treatment outcomes in sleep apnoea-hypopnoea syndrome ( SAHS ) have had mixed success .\
OBJECTIVE	Most have concentrated on following the use of a continuous positive airway pressure ( CPAP ) machines ; poorer users may not return for machine readings , so any compliance study must take into account rates of attendance rates .\
OBJECTIVE	We hypothesised that a series of additional , early support measures would improve re-attendance over a sustained period .\
METHODS	Prospective , single-blinded interventional study .\
METHODS	Seventy-two consecutive patients starting CPAP for SAHS were randomised to receive standard follow-up or extra early support .\
METHODS	Attendance rates , CPAP use , Epworth scores , side-effects scores and number of changes to equipment were compared , by intent to treat , in both groups at 1 and 12 months .\
RESULTS	Re-attendance rates were higher in the intervention group at 1 month ( P = 0.04 ) , 6 months ( P = 0.07 ) and 12 months ( P = 0.12 ) .\
RESULTS	Those who defaulted tended previously to be poor users of the CPAP machine .\
RESULTS	For those who re-attended there was no difference in machine use or other outcomes .\
CONCLUSIONS	Simple interventions while commencing CPAP improve re-attendance with maximal benefit early on .\
CONCLUSIONS	This could provide more opportunities for solving problems early or considering alternative treatments .\
CONCLUSIONS	By confirming that poorer CPAP users eventually have higher default rates we recommend that future studies on CPAP compliance should first account for re-attendance rates .\
\
###21670942\
OBJECTIVE	To investigate the feasibility and effects of a physical exercise programme on functioning and health-related quality of life in adults with myotonic dystrophy type 1 .\
METHODS	A randomized controlled trial .\
METHODS	Thirty-five adults with myotonic dystrophy type 1 .\
METHODS	After stratification for level of functioning , study participants were assigned by lot to either a training group or a control group .\
METHODS	Training-group participants attended a 60-minute comprehensive group-training programme , Friskis & Svettis Open Doors , twice a week for 14 weeks .\
METHODS	The six-minute walk test was the primary outcome measure and the timed-stands test , the timed up-and-go test , the Epworth sleepiness scale and the Short Form-36 health survey were secondary outcome measures .\
RESULTS	Intention-to-treat analyses revealed no significant differences in any outcome measures , except for an increased between-group difference after intervention in the Short Form-36 mental health subscale and a decrease in the vitality subscale for the control group .\
RESULTS	The programme was well tolerated and many training-group participants perceived subjective changes for the better .\
RESULTS	No negative effects were reported .\
CONCLUSIONS	The Friskis & Svettis Open Doors programme was feasible for adults with myotonic dystrophy type 1 who had been screened for cardiac involvement , had distal or mild-to-moderate proximal muscle impairment , and no severe cognitive impairments .\
CONCLUSIONS	No beneficial or detrimental effects were evident .\
\
###10219029\
OBJECTIVE	To assess the rise in intraocular pressure following phacoemulsification and whether it can be modified by the architecture of the peripheral corneal incision for the second instrument .\
METHODS	Frimley Park Hospital , Frimley , United Kingdom .\
METHODS	Forty-two patients had intraocular pressures measured from both eyes preoperatively , then underwent routine scleral section phacoemulsification .\
METHODS	They were randomly assigned to perpendicular ( blow-off valve ) and oblique ( water-tight ) peripheral corneal incision groups .\
METHODS	Postoperative intraocular pressures were measured at 3 , 6 , 12 and 18 hours .\
METHODS	Pressures from the unoperated eyes were used as controls .\
METHODS	Aqueous release from the second instrument peripheral corneal incisions and frown scleral incision were assessed using the Seidel 's test .\
RESULTS	There was a rise in intraocular pressure in both groups compared to the control eyes ( mean 10.95 + / -2.19 mmHg , P < 0.00005 ) at 6 hours .\
RESULTS	The difference between the groups was significant at 12 hours ( mean difference 3.35 mmHg , P < 0.05 ) ; 63.6 % of the perpendicular incisions and 15 % of the oblique incisions were Seidel 's positive .\
RESULTS	The frown incision did not leak .\
CONCLUSIONS	This study documents the natural history of the rise in intraocular pressure following phacoemulsification peaking at 6 hours .\
CONCLUSIONS	Pharmacological agents should be administered to cover this period .\
CONCLUSIONS	The perpendicular peripheral corneal incision had a tendency to act as a blow-off valve allowing release of aqueous when intraocular pressures were elevated in the first 18 hours following phacoemulsification .\
CONCLUSIONS	This phenomenon is likely to result in a reduction in rise of intraocular pressure compared to the oblique peripheral corneal incision group which tended to be water-tight .\
\
###12697866\
OBJECTIVE	To evaluate the safety of recombinant human keratinocyte growth factor ( KGF ) when administered with fluorouracil ( FU ) in patients with metastatic colorectal cancer .\
METHODS	Patients ( N = 81 ) received KGF by intravenous ( IV ) bolus on days 1 to 3 , followed by FU 425 mg/m2/d IV bolus plus leucovorin 20 mg/m2/d IV on days 4 to 8 .\
METHODS	KGF dose levels were 1 , 10 , 20 , 40 , 60 , and 80 microg/kg/d .\
METHODS	A randomized , placebo-controlled design was employed ( 2:1 randomization of KGF to placebo ) .\
METHODS	Oral mucositis was assessed by examination on days 1 , 4 , 8 , 15 , and 28 .\
METHODS	In addition , patients provided daily assessments of oral symptoms using a self-administered questionnaire .\
RESULTS	Skin and oral events occurred in 13 of 18 patients ( eight patients , grade 1 ; four patients , grade 2 ; and one patient , grade 3 ) treated with 60 and 80 microg/kg of KGF and three of 11 patients treated with 40 microg/kg ( grade 1 ) .\
RESULTS	These symptoms were dose limiting in three cases ( ie , in two of 10 patients treated with 80 microg/kg and in one of eight patients treated with 60 microg/kg ) .\
RESULTS	The frequency of grade 2 to 4 mucositis was 43 % in patients treated with KGF , compared with 67 % in patients treated with placebo ( P = .06 ) .\
RESULTS	Patient self-assessments of oral pain and clinical assessments of mucositis showed good correlation ( Kendall 's tau = 0.75 ) .\
CONCLUSIONS	KGF is generally well tolerated when administered IV at doses up to 40 microg/kg/d for 3 days before a 5-day course of FU plus leucovorin .\
CONCLUSIONS	A clinically meaningful biologic effect was also suggested in that patients treated with the epithelial growth factor KGF had a lower rate of grade 2 to 4 mucositis than did patients treated with placebo .\
\
###23265585\
OBJECTIVE	Outcomes in the Carotid Revascularization Endarterectomy versus Stenting Trial ( CREST ) did not differ between carotid artery stenting ( CAS ) and carotid endarterectomy ( CEA ) for the composite primary end point of stroke , myocardial infarction ( MI ) , or death during the periprocedural period or ipsilateral stroke within 4 years .\
OBJECTIVE	Rigorous credentialing and training of interventionists , including vascular surgeons , were required for the randomization phase of CREST .\
OBJECTIVE	Because the lead-in phase of CREST had suggested higher perioperative risks after CAS performed by vascular surgeons , the purpose of this analysis was to examine differences in outcomes after randomization between CAS and CEA performed by vascular surgeons .\
METHODS	CREST is a prospective randomized controlled trial with blinded end point adjudication .\
METHODS	Vascular surgeons performed 237 ( 21 % ) of the CAS procedures and 765 ( 65 % ) of the CEA procedures among 2320 patients who received their assigned treatment .\
METHODS	Proportional hazards analyses were used to estimate the relative efficacy of CAS vs CEA for thecomposite primary end point and also for stroke and death .\
RESULTS	Among 2502 randomized patients , 1321 ( 53 % ) were symptomatic and 1181 ( 47 % ) were asymptomatic .\
RESULTS	For procedures performed exclusively by vascular surgeons , the primary end point did not differ between CAS and CEA at 4-year follow-up ( 6.2 % vs 5.6 % , respectively ; hazard ratio [ HR ] , 1.30 ; 95 % confidence interval [ CI ] , 0.70-2 .41 ; P = .41 ) In this subgroup , the periprocedural stroke and death rates were higher after CAS than CEA for symptomatic patients ( 6.1 % vs 1.3 % ; P = .01 ) .\
RESULTS	Asymptomatic patients also had slightly higher stroke and death rates after CAS ( 2.6 % vs 1.1 % ; P = .20 ) , althoughthis difference did not reach statistical significance .\
RESULTS	Conversely , cranial nerve injuries ( 0.0 % vs 5.0 % ; P < .001 ) were lessfrequentafter CAS than CEA .\
RESULTS	The MI rates were slightly lower after CAS ( 1.3 % vs 2.6 % ; P = .24 ) .\
RESULTS	In performing CAS , vascular surgeonshad outcomes for the periprocedural primary end point comparable to the outcomes of all interventionists ( HR , 0.99 ; 95 % CI , 0.50-2 .00 ) after adjusting for age , sex , and symptomatic status .\
RESULTS	Vascular surgeons also had similar results after CEA for the periprocedural primary end point compared with other surgeons ( HR , 0.73 ; 95 % CI , 0.42-1 .27 ) .\
CONCLUSIONS	When performed by surgeons , CAS and CEA have similar net outcomes , although the periprocedural risksvary ( lower stroke with CEA and lower MI with CAS ) .\
CONCLUSIONS	These data suggest that appropriately trained vascular surgeons may safely offer both CEA and CAS for the prevention of stroke .\
CONCLUSIONS	The remarkably low stroke and death rates after CEAperformed by vascular surgeons in CREST , particularly among symptomatic patients , represent the best outcomes ever reported after carotid interventions from a randomized controlled trial .\
CONCLUSIONS	ClinicalTrials.gov identifier : NCT0000473 .\
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###17202885\
METHODS	A randomized controlled trial .\
OBJECTIVE	To assess the effectiveness of decompressive surgery as compared with nonoperative measures in the treatment of patients with lumbar spinal stenosis .\
BACKGROUND	No previous randomized trial has assessed the effectiveness of surgery in comparison with conservative treatment for spinal stenosis .\
METHODS	Four university hospitals agreed on the classification of the disease , inclusion and exclusion criteria , radiographic routines , surgical principles , nonoperative treatment options , and follow-up protocols .\
METHODS	A total of 94 patients were randomized into a surgical or nonoperative treatment group : 50 and 44 patients , respectively .\
METHODS	Surgery comprised undercutting laminectomy of the stenotic segments in 10 patients augmented with transpedicular fusion .\
METHODS	The primary outcome was based on assessment of functional disability using the Oswestry Disability Index ( scale , 0-100 ) .\
METHODS	Data on the intensity of leg and back pain ( scales , 0-10 ) , as well as self-reported and measured walking ability were compiled at randomization and at follow-up examinations at 6 , 12 , and 24 months .\
RESULTS	Both treatment groups showed improvement during follow-up .\
RESULTS	At 1 year , the mean difference in favor of surgery was 11.3 in disability ( 95 % confidence interval [ CI ] , 4.3-18 .4 ) , 1.7 in leg pain ( 95 % CI , 0.4-3 .0 ) , and 2.3 ( 95 % CI , 1.1-3 .6 ) in back pain .\
RESULTS	At the 2-year follow-up , the mean differences were slightly less : 7.8 in disability ( 95 % CI , 0.8-14 .9 ) 1.5 in leg pain ( 95 % CI , 0.3-2 .8 ) , and 2.1 in back pain ( 95 % CI , 1.0-3 .3 ) .\
RESULTS	Walking ability , either reported or measured , did not differ between the two treatment groups .\
CONCLUSIONS	Although patients improved over the 2-year follow-up regardless of initial treatment , those undergoing decompressive surgery reported greater improvement regarding leg pain , back pain , and overall disability .\
CONCLUSIONS	The relative benefit of initial surgical treatment diminished over time , but outcomes of surgery remained favorable at 2 years .\
CONCLUSIONS	Longer follow-up is needed to determine if these differences persist .\
\
###23577773\
OBJECTIVE	Improved device technology has caused a renewed interest in peripheral nerve field stimulation ( PNfS ) .\
OBJECTIVE	This study sought to obtain preliminary estimates of the safety and efficacy of PNfS in patients with localized chronic intractable pain of the back .\
METHODS	This Institutional Review Board-approved , prospective , randomized , controlled , crossover study consisted of two phases .\
METHODS	During phase I , patients rotated through four stimulation groups ( minimal , subthreshold , low frequency , and standard stimulation ) .\
METHODS	If a 50 % reduction in pain was achieved during any of the three active stimulation groups ( responder ) , the patient proceeded to phase II , which began with implant of the permanent system and lasted 52 weeks .\
METHODS	The primary endpoint was a reduction in pain , assessed by the visual analog scale ( VAS ) .\
METHODS	Analysis of variance , including the effects of patient , treatment , and study period , was used for phase I results .\
METHODS	Phase II results were analyzed by paired t-tests .\
RESULTS	A total of 44 patients were enrolled at five sites .\
RESULTS	Of these patients , 32 were implanted with a trial system and 30 completed phase I.\
RESULTS	During phase I , there were significant differences in mean VAS scores between minimal stimulation and subthreshold stimulation ( p = 0.003 ) , low frequency stimulation ( p < 0.001 ) , and standard stimulation ( p < 0.001 ) .\
RESULTS	Twenty-four patients were classified as responders to the therapy , and 23 patients received permanent system placement .\
RESULTS	Significant differences in VAS scores were observed between baseline and all follow-up visits during phase II ( p < 0.001 ) CONCLUSIONS : The results provide evidence to support safety and effectiveness of PNfS as an aid in the management of chronic , localized back pain .\
\
###16020559\
OBJECTIVE	To prospectively evaluate clinical utility , patient outcomes , and costs of contrast material-enhanced magnetic resonance ( MR ) angiography compared with multi-detector row computed tomographic ( CT ) angiography for initial imaging in the diagnostic work-up of patients with peripheral arterial disease .\
METHODS	Institutional review board approval and informed consent were obtained .\
METHODS	Patients referred for diagnostic imaging work-up to evaluate the feasibility of a revascularization procedure were randomly assigned to undergo either MR angiography or CT angiography .\
METHODS	Clinical utility was assessed with therapeutic confidence ( scale of 0-10 ) at initial imaging and with the need for additional imaging .\
METHODS	Patient outcomes included ankle-brachial index , maximum walking distance , change in clinical status , and health-related quality of life .\
METHODS	Actual diagnostic and therapeutic costs were calculated from the hospital perspective .\
METHODS	Differences between group means were calculated with unpaired t tests and 95 % confidence intervals .\
RESULTS	A total of 157 consecutive patients with peripheral arterial disease were prospectively randomized to undergo MR angiography ( 51 men , 27 women ; mean age , 63 years ) or CT angiography ( 50 men , 29 women ; mean age , 64 years ) .\
RESULTS	For one of the 78 patients in the MR group , no data were available .\
RESULTS	Mean confidence for MR angiography ( 7.7 ) was slightly lower than that for CT angiography ( 8.0 , P = .8 ) .\
RESULTS	During 6 months of follow-up , 13 patients in the MR group compared with 10 patients in the CT group underwent additional vascular imaging ( P = .5 ) .\
RESULTS	Although not statistically significant , there was a consistent trend of less improvement in the MR group across all patient outcomes .\
RESULTS	The average cost for diagnostic imaging was 359 ( $ 438 ) higher in the MR group than in the CT group ( 95 % confidence interval : 209 , 511 [ $ 255 , $ 623 ] ; P < .001 ) .\
RESULTS	Therapeutic costs were higher in the MR group , but the difference was not significant .\
CONCLUSIONS	The results suggest that CT angiography has some advantages over MR angiography in the initial evaluation of peripheral arterial disease .\
\
###22398159\
OBJECTIVE	A double blind randomized cross over trial to compare the rate of decortication , safety and efficacy of intrapleural instillation of Alteplase vs. Placebo in empyema and complicated parapneumonic effusions ( CPE ) .\
METHODS	Patients diagnosed with empyema or CPE and considered for surgery were given the option to enter into this trial .\
METHODS	Intrapleural instillation of the ` Drug ' was given daily for three days .\
METHODS	Patient that failed the first arm of the trial were offered surgery or to cross over to the second arm .\
METHODS	Failure was documented if pleural effusions did not improve by 50 % on CT scans after three doses of the ` Drug ' or if these effusions recurred within six weeks .\
RESULTS	One hundred and eight patients were evaluated and one hundred enrolled in the trial .\
RESULTS	32 patients were excluded , 29 for noninfectious loculated effusions , two for protocol violation and one for bleeding at chest tube site .\
RESULTS	There were 17 patients with empyema and 51 patients with CPE .\
RESULTS	58 of the 61 patients ( 26 crossed over ) with empyema/CPE resolved with Alteplase therapy compared to 4 of the 32 patients ( one crossed over ) treated with Placebo ( p value < 0.001 ) .\
RESULTS	None of the patients went to surgery .\
RESULTS	Adverse events with Alteplase therapy compared to Placebo were not statistically significant , with chest pain and bleeding complications being the most common .\
CONCLUSIONS	Intrapleural instillation of Alteplase is significantly more effective than Placebo in patients with empyema and PPE ( 95 % vs. 12 % ) .\
CONCLUSIONS	This study demonstrates it is safe and efficacious with minimal adverse reactions .\
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###9893104\
OBJECTIVE	We hypothesized that participants of intervention studies have an unfavourable lifestyle at the weekend compared with the rest of the week , thus affecting the concentrations of components in samples drawn on Mondays .\
METHODS	The hypothesis was examined using data from the Oslo Diet and Exercise Study , a 2 x 2 randomized intervention trial on diet and exercise involving 209 participants .\
METHODS	Each person chose which day of the week to attend for blood sampling , both before and after the 1 year of intervention .\
METHODS	Comparison of mean concentrations of the components measured , in samples drawn on Mondays vs. non-Mondays , both at the start and at the end of intervention .\
RESULTS	At the start , nine components , from haemostasis , carbohydrate and lipid metabolism , showed a difference of more than 10 % between Monday and non-Monday values , all Monday values differing from the non-Monday values in a cardiovascularly unfavourable direction .\
RESULTS	Participants starting and ending on a Monday showed the unfavourable profile both times , and those who were examined both times on a non-Monday showed a consistently favourable profile , whereas those who changed the day of examination at the start and end changed profile accordingly .\
CONCLUSIONS	The lifestyle-related components examined here showed differences between Monday and non-Monday values , which were not due to a selection bias .\
CONCLUSIONS	We suggest they may be related to a different lifestyle at the weekend compared with ordinary working days .\
CONCLUSIONS	If such effects are not recognized and properly taken into account , they may markedly affect the outcome of intervention studies .\
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###11292003\
BACKGROUND	Studies have shown that buprenorphine , a partial mu opioid agonist , effectively reduces heroin taking .\
BACKGROUND	While previous research with buprenorphine utilized a liquid formulation , a tablet formulation is proposed for clinical use .\
BACKGROUND	However , because recent research suggests that the liquid and tablet differ in bio-availability , it is unclear what dose of the buprenorphine tablet effectively antagonizes the reinforcing effects of heroin .\
OBJECTIVE	The present study was designed to compare the effects of two sublingual doses of buprenorphine maintenance on heroin self-administration .\
METHODS	Eight heroin-dependent men participated in a 6-week , double-blind , placebo-controlled inpatient study to evaluate the reinforcing effects of intravenous heroin ( 0 , 6.25 , 12.5 , 25 mg ) during maintenance on 8 or 16 mg sublingual buprenorphine .\
METHODS	Participants first sampled the available dose of heroin , and then were allowed to respond under a progressive ratio schedule for either heroin or $ 20 .\
METHODS	For each heroin dose , one sample session and three choice sessions occurred .\
METHODS	Two sessions per day were conducted .\
METHODS	A sample session was followed by the first choice session on one day , and the second and third choice sessions occurred on the following day .\
METHODS	These sessions were conducted while participants were maintained on daily doses of 8 or 16 mg buprenorphine ( 3 weeks each ) .\
RESULTS	Relative to placebo , 12.5 and 25 mg heroin produced significant increases in break point values under both maintenance dose conditions .\
RESULTS	The mean break point value for 12.5 mg heroin was significantly lower under 16 mg buprenorphine , compared to 8 mg .\
CONCLUSIONS	These results demonstrate that the reinforcing effects of heroin were not fully antagonized by these doses of the tablet formulation of buprenorphine , and that 16 mg buprenorphine reduced heroin self-administration relative to 8 mg .\
\
###25788584\
BACKGROUND	In recent years , there has been a growing body of evidence indicating that replacing cholecalciferol ( vitamin D ) with 25-hydroxycholecalciferol [ 25 ( OH ) D ] through dietary supplementation enhances breast meat yield in broiler chickens .\
BACKGROUND	However , the underlying molecular mechanisms are still unknown .\
OBJECTIVE	We investigated the effect of 25 ( OH ) D on male broiler growth performance ( body weight , feed intake , feed conversion ratio , and breast meat yield ) , muscle protein synthesis , and the potential underlying molecular mechanisms .\
METHODS	Male Cobb 500 broiler chickens were divided into 4 body weight-matched groups and received a control diet with normal cholecalciferol ( 2760 IU/kg feed ) for 42 d , a diet with high concentrations of cholecalciferol ( 5520 IU/kg feed ) for 42 d , or a diet with 25 ( OH ) D ( 5520 IU/kg feed ) for 42 d ( HyD-42 ) .\
METHODS	A fourth group consumed the HyD-42 for 21 d and then control feed for 21 d ( HyD-21 ) ( n = 360 birds , 12 replicates/treatment ) .\
METHODS	Food and clean water were available for ad libitum consumption .\
METHODS	At the end of the 42-d experiment , protein turnover was measured by phenylalanine flooding dose .\
METHODS	Breast muscle tissues were collected and protein synthesis-related gene and protein expression were measured by real time polymerase chain reaction and Western blot , respectively .\
METHODS	Functional studies were performed in vitro with the use of a quail myoblast ( QM7 ) cell line .\
METHODS	QM7 cells were treated with 2 doses ( 1 nM and 10 nM ) of cholecalciferol or 25 ( OH ) D alone or in combination with 100 nM rapamycin , and cell proliferation was determined by cell proliferation assay .\
METHODS	Protein synthesis-related gene and protein expression were also determined .\
RESULTS	The HyD-42 increased 25 ( OH ) D circulating concentrations by 126 % ( P < 0.05 ) , enhanced breast meat yield ( P < 0.05 ) , and increased the fractional rate of protein synthesis by 3-fold ( P < 0.05 ) compared with the control diet .\
RESULTS	Molecular analyses revealed that breast muscle from chickens consuming the HyD-42 expressed significantly higher concentrations of vitamin D receptor ( VDR ) , phospho mechanistic target of rapamycin ( Ser2481 ) , phospho ribosomal P70 S6 kinase ( RPS6K ) ( Thr421/Ser424 ) , and antigen Ki-67 ( Ki67 ) compared with the other groups .\
RESULTS	In line with the in vivo data , in vitro functional studies showed that cells treated with 25 ( OH ) D for 24 h had increased VDR expression , and activated the mechanistic target of rapamycin ( mTOR ) / S6 kinase ( S6K ) pathway , enhanced Ki67 protein concentrations , and induced QM7 cell proliferation compared with untreated or cholecalciferol-treated cells .\
RESULTS	Blocking the mTOR pathway with rapamycin reversed these effects .\
CONCLUSIONS	Taken together , our findings provide evidence that the effects of 25 ( OH ) D on male broiler breast muscle are likely mediated through the mTOR-S6K pathway .\
\
###16077391\
OBJECTIVE	This study investigated whether the activation of coagulation , fibrinolysis , and endothelium occurring during the first postoperative month after on-pump coronary artery bypass surgery differs from that after off-pump coronary artery bypass grafting .\
METHODS	Thirty-five patients candidates to coronary surgery were randomized to undergo on-pump ( n = 18 ) or off-pump ( n = 17 ) coronary artery bypass grafting .\
METHODS	Blood samples were collected before the intervention and to 1 month after surgery .\
RESULTS	Prothrombin fragment F1 .2 , thrombin-antithrombin complex , and D-dimer increased after surgery and were persistently higher than preoperative values as late as 30 postoperative days in both on - and off-pump groups ; higher levels of these variables were detected after on-pump surgery relative to off-pump surgery only at the time point after termination of cardiopulmonary bypass ( fragment F1 .2 and thrombin-antithrombin complex ) or from bypass end to 8 postoperative days ( D-dimer ) .\
RESULTS	Fibrinogen levels decreased after surgery and then increased in parallel in both groups to 8 days after surgery .\
RESULTS	The von Willebrand factor level increased postoperatively in both groups and returned to baseline 30 days after surgery ; it was higher after on-pump surgery from bypass end to 8 postoperative days .\
RESULTS	Soluble vascular cell adhesion molecule 1 was increased significantly from baseline in both groups 30 days after surgery , with no difference between groups .\
CONCLUSIONS	Patients undergoing off-pump surgery showed protection against activation of coagulation and fibrinolysis and against endothelial injury only during the intraoperative period ; this was followed by the development of a prothrombotic pattern comparable to that of patients undergoing on-pump surgery lasting at least as late as 30 days after surgery .\
\
###20540803\
BACKGROUND	HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas .\
BACKGROUND	A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings .\
BACKGROUND	The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza , Tanzania .\
METHODS	A total of 1146 women at increased risk of HIV acquisition working as alcohol and food vendors or in bars , restaurants , hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza .\
METHODS	During preparations for the trial , participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants .\
METHODS	Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions .\
METHODS	A comprehension checklist is administered by clinical staff to all participants at screening , enrolment , 12 , 24 , 40 and 50 week follow-up visits during the trial .\
METHODS	To investigate women 's perceptions and experiences of the trial , including how well participants internalize and retain key messages provided through a continuous informed consent process , a random sub-sample of 102 women were invited to participate in in-depth interviews ( IDIs ) conducted immediately after their 4 , 24 and 52 week follow-up visits .\
RESULTS	99 women completed interviews at 4-weeks , 83 at 24-weeks , and 74 at 52 weeks ( a total of 256 interviews ) .\
RESULTS	In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV ; that this is the key reason for conducting the trial ; and that women should stop using gel in the event of pregnancy .\
CONCLUSIONS	Providing information to trial participants in a focussed , locally-appropriate manner , using methods developed in consultation with the community , and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting .\
CONCLUSIONS	This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings .\
BACKGROUND	Current Controlled Trials ISRCTN64716212 .\
\
###16267322\
BACKGROUND	Natalizumab , a humanized monoclonal antibody against alpha4 integrin , inhibits leukocyte adhesion and migration into inflamed tissue .\
METHODS	We conducted two controlled trials to evaluate natalizumab as induction and maintenance therapy in patients with active Crohn 's disease .\
METHODS	In the first trial , 905 patients were randomly assigned to receive 300 mg of natalizumab or placebo at weeks 0 , 4 , and 8 .\
METHODS	The primary outcome was response , defined by a decrease in the Crohn 's Disease Activity Index ( CDAI ) score of at least 70 points , at week 10 .\
METHODS	In the second trial , 339 patients who had a response to natalizumab in the first trial were randomly reassigned to receive 300 mg of natalizumab or placebo every four weeks through week 56 .\
METHODS	The primary outcome was a sustained response through week 36 .\
METHODS	A secondary outcome in both trials was disease remission ( a CDAI score of less than 150 ) .\
RESULTS	In the first trial , the natalizumab and placebo groups had similar rates of response ( 56 percent and 49 percent , respectively ; P = 0.05 ) and remission ( 37 percent and 30 percent , respectively ; P = 0.12 ) at 10 weeks .\
RESULTS	Continuing natalizumab in the second trial resulted in higher rates of sustained response ( 61 percent vs. 28 percent , P < 0.001 ) and remission ( 44 percent vs. 26 percent , P = 0.003 ) through week 36 than did switching to placebo .\
RESULTS	Serious adverse events occurred in 7 percent of each group in the first trial and in 10 percent of the placebo group and 8 percent of the natalizumab group in the second trial .\
RESULTS	In an open-label extension study , a patient treated with natalizumab died from progressive multifocal leukoencephalopathy , associated with the JC virus , a human polyomavirus .\
CONCLUSIONS	Induction therapy with natalizumab for Crohn 's disease resulted in small , nonsignificant improvements in response and remission rates .\
CONCLUSIONS	Patients who had a response had significantly increased rates of sustained response and remission if natalizumab was continued every four weeks .\
CONCLUSIONS	The benefit of natalizumab will need to be weighed against the risk of serious adverse events , including progressive multifocal leukoencephalopathy .\
CONCLUSIONS	( ClinicalTrials.gov numbers , NCT00032786 and NCT00032799 . )\
\
###22591950\
OBJECTIVE	Enhanced reactivity to substance related cues is a central characteristic of addiction and has been associated with increased activity in motivation , attention , and memory related brain circuits and with a higher probability of relapse .\
OBJECTIVE	Modafinil was promising in the first clinical trials in cocaine dependence , and was able to reduce craving in addictive disorders .\
OBJECTIVE	However , its mechanism of action remains to be elucidated .\
OBJECTIVE	In this functional magnetic resonance imaging ( fMRI ) study therefore , cue reactivity in cocaine dependent patients was compared to cue reactivity in healthy controls ( HCs ) under modafinil and placebo conditions .\
METHODS	An fMRI cue reactivity study , with a double-blind , placebo-controlled cross-over challenge with a single dose of modafinil ( 200mg ) was employed in 13 treatment seeking cocaine dependent patients and 16 HCs .\
RESULTS	In the placebo condition , watching cocaine-related pictures ( versus neutral pictures ) resulted in higher brain activation in the medial frontal cortex , anterior cingulate cortex , angular gyrus , left orbitofrontal cortex , and ventral tegmental area ( VTA ) in the cocaine dependent group compared to HCs .\
RESULTS	However , in the modafinil condition , no differences in brain activation patterns were found between cocaine dependent patients and HCs .\
RESULTS	Group interactions revealed decreased activity in the VTA and increased activity in the right ACC and putamen in the modafinil condition relative to the placebo condition in cocaine dependent patients , whereas such changes were not present in healthy controls .\
RESULTS	Decreases in self-reported craving when watching cocaine-related cues after modafinil administration compared to the placebo condition were associated with modafinil-induced increases in ACC and putamen activation .\
CONCLUSIONS	Enhanced cue reactivity in the cocaine dependent group compared to healthy controls was found in brain circuitries related to reward , motivation , and autobiographical memory processes .\
CONCLUSIONS	In cocaine dependent patients , these enhanced brain responses were attenuated by modafinil , mainly due to decreases in cue - reactivity in reward-related brain areas ( VTA ) and increases in cue reactivity in cognitive control areas ( ACC ) .\
CONCLUSIONS	These modafinil-induced changes in brain activation in response to cocaine-related visual stimuli were associated with diminished self-reported craving .\
CONCLUSIONS	These findings imply that in cocaine dependent patients , modafinil , although mainly known as a cognitive enhancer , acts on both the motivational and the cognitive brain circuitry .\
\
###24184285\
BACKGROUND	An important treatment goal for burn wounds is to promote early wound closure .\
BACKGROUND	This study identifies factors associated with delayed re-epithelialization following pediatric burn .\
METHODS	Data were collected from August 2011 to August 2012 , at a pediatric tertiary burn center .\
METHODS	A total of 106 burn wounds were analyzed from 77 participants aged 4-12 years .\
METHODS	Percentage of wound re-epithelialization at each dressing change was calculated using Visitrak .\
METHODS	Mixed effect regression analysis was performed to identify the demographic factors , wound and clinical characteristics associated with delayed re-epithelialization .\
RESULTS	Burn depth determined by laser Doppler imaging , ethnicity , pain scores , total body surface area ( TBSA ) , mechanism of injury and days taken to present to the burn center were significant predictors of delayed re-epithelialization , accounting for 69 % of variance .\
RESULTS	Flame burns delayed re-epithelialization by 39 % compared to all other mechanisms ( p = 0.003 ) .\
RESULTS	When initial presentation to the burn center was on day 5 , burns took an average of 42 % longer to re-epithelialize , compared to those who presented on day 2 post burn ( p < 0.000 ) .\
RESULTS	Re-epithelialization was delayed by 14 % when pain scores were reported as 10 ( on the FPS-R ) , compared to 4 on the first dressing change ( p = 0.015 ) for children who did not receive specialized preparation/distraction intervention .\
RESULTS	A larger TBSA was also a predictor of delayed re-epithelialization ( p = 0.030 ) .\
RESULTS	Darker skin complexion re-epithelialized 25 % faster than lighter skin complexion ( p = 0.001 ) .\
CONCLUSIONS	Burn depth , mechanism of injury and TBSA are always considered when developing the treatment and surgical management plan for patients with burns .\
CONCLUSIONS	This study identifies other factors influencing re-epithelialization , which can be controlled by the treating team , such as effective pain management and rapid referral to a specialized burn center , to achieve optimal outcomes .\
\
###18342453\
OBJECTIVE	Cancer patients who undergo radiotherapy remain at life-long risk of radiation-induced injury to normal tissues .\
OBJECTIVE	We conducted a randomized , controlled , double-blind crossover trial with long-term follow-up to evaluate the effectiveness of hyperbaric oxygen for refractory radiation proctitis .\
METHODS	Patients with refractory radiation proctitis were randomized to hyperbaric oxygen at 2.0 atmospheres absolute ( Group 1 ) or air at 1.1 atmospheres absolute ( Group 2 ) .\
METHODS	The sham patients were subsequently crossed to Group 1 .\
METHODS	All patients were re-evaluated by an investigator who was unaware of the treatment allocation at 3 and 6 months and Years 1-5 .\
METHODS	The primary outcome measures were the late effects normal tissue-subjective , objective , management , analytic ( SOMA-LENT ) score and standardized clinical assessment .\
METHODS	The secondary outcome was the change in quality of life .\
RESULTS	Of 226 patients assessed , 150 were entered in the study and 120 were evaluable .\
RESULTS	After the initial allocation , the mean SOMA-LENT score improved in both groups .\
RESULTS	For Group 1 , the mean was lower ( p = 0.0150 ) and the amount of improvement nearly twice as great ( 5.00 vs. 2.61 , p = 0.0019 ) .\
RESULTS	Similarly , Group 1 had a greater portion of responders per clinical assessment than did Group 2 ( 88.9 % vs. 62.5 % , respectively ; p = 0.0009 ) .\
RESULTS	Significance improved when the data were analyzed from an intention to treat perspective ( p = 0.0006 ) .\
RESULTS	Group 1 had a better result in the quality of life bowel bother subscale .\
RESULTS	These differences were abolished after the crossover .\
CONCLUSIONS	Hyperbaric oxygen therapy significantly improved the healing responses in patients with refractory radiation proctitis , generating an absolute risk reduction of 32 % ( number needed to treat of 3 ) between the groups after the initial allocation .\
CONCLUSIONS	Other medical management requirements were discontinued , and advanced interventions were largely avoided .\
CONCLUSIONS	Enhanced bowel-specific quality of life resulted .\
\
###23912692\
OBJECTIVE	To compare the efficacy and toxicity of single-agent gemcitabine with gemcitabine plus cisplatin ( G+C ) in patients with metastatic pancreatic cancer\
METHODS	Forty-six patients with metastatic pancreatic cancer were randomized to receive gemcitabine alone ( n = 25 ; 1,000 mgm ( -2 ) ) or G+C ( n = 21 ; 1,000 mgm ( -2 ) gemcitabine and 25mgm ( -2 ) cisplatin ) .\
METHODS	Treatments were administered once a week for 3weeks and repeated every 4weeks .\
RESULTS	Patient characteristics were comparable between the gemcitabine alone and G+C groups .\
RESULTS	The gemcitabine dose intensity was similar between the gemcitabine alone and G+C groups ( 68432 vs. 61731mgm ( -2 ) week ( -1 ) ) .\
RESULTS	The cisplatin dose intensity was 15.10.9 mgm ( -2 ) week ( -1 ) 9.91.8 weeks .\
RESULTS	Partial response rates were 8 % ( 2/25 ) for gemcitabine alone and 4.8 % ( 1/21 ) for G+C ( p = 1 ) .\
RESULTS	The median survival and median time to progression were 7.7 and 4.6 months for gemcitabine alone and 7.9 and 3.6 months for G+C , respectively ( p = 0.752 and p = 0.857 , respectively ) .\
RESULTS	Clinical benefit was 36 % for gemcitabine alone and 29 % for G+C ( p = 0.592 ) .\
RESULTS	Quality-adjusted life months were 5.60.3 for the gemcitabine alone group and 3.80.2 for the G+C group ( p < 0.001 ) .\
RESULTS	The frequency of grade 3/4 neutropenia ( 8 vs. 19 % ) and anemia ( 8 vs. 10 % ) and the number of hospitalization days per month of survival ( 4.71.3 vs. 6.31.6 days ; p = 0.431 ) were not significantly different between patients who received gemcitabine alone and those who received G+C .\
RESULTS	However , patients in the G+C group had a higher rate of thrombocytopenia than did patients in the gemcitabine alone group ( 62 vs. 24 % ; p = 0.009 ) .\
CONCLUSIONS	Gemcitabine alone and G+C had comparable and modest response rates in metastatic pancreatic cancer , but gemcitabine alone produced less toxicities than did G+C .\
\
###18005310\
OBJECTIVE	To assess the effectiveness of cessation of irrigation before harvesting in reducing microbial contamination of lettuce irrigated with wastewater in urban vegetable farming in Ghana .\
METHODS	Assessment was done under actual field conditions with urban vegetable farmers in Ghana .\
METHODS	Trials were arranged in completely randomized block design and done both in the dry and wet seasons .\
METHODS	Seven hundred and twenty-six lettuce samples and 36 water samples were analysed for thermotolerant coliforms and helminth eggs .\
RESULTS	On average , 0.65 log units for indicator thermotolerant coliforms and 0.4 helminth eggs per 100 g of lettuce were removed on each non-irrigated day from lettuce in the dry season .\
RESULTS	This corresponded to a daily loss of 1.4 tonnes/ha of fresh weight of lettuce .\
RESULTS	As an input for exposure analysis to make risk estimates , the decay coefficient , k , for thermotolerant coliforms was 0.66 / day for the wet season and 1.49 / day for the dry season .\
CONCLUSIONS	In combination with other measures for improving water quality , the measure can significantly reduce faecal contamination of lettuce during the dry season .\
CONCLUSIONS	However , it is not suitable for the wet season due to unfavourable conditions for pathogen die-off and re-contamination by splashes from contaminated soils .\
CONCLUSIONS	The results provide a good basis for risk assessments and for devising more appropriate measures for risk reduction , especially in sub-Saharan Africa .\
\
###17010857\
OBJECTIVE	To determine whether aspiration of lens epithelial cells ( LECs ) from under the anterior capsule reduces postoperative contraction of the capsulorhexis aperture .\
METHODS	Stoke Mandeville Hospital , Aylesbury , Buckinghamshire , United Kingdom .\
METHODS	This prospective randomized observer-masked study comprised 100 patients who had routine phacoemulsification by the same surgeon at a district general hospital in the United Kingdom .\
METHODS	The postoperative changes in capsulorhexis apertures and anterior capsule opacification ( ACO ) between Group A ( aspiration of LECs ) and Group B ( control ) were compared .\
METHODS	Digital retroillumination images of the capsulorhexis aperture were taken 1 week and 3 months postoperatively .\
METHODS	The area of capsulorhexis aperture was determined with computer software , and capsule opacification was graded subjectively .\
RESULTS	Three months postoperatively , the mean decrease in capsulorhexis aperture was 1.9 % in Group A and 5.6 % in Group B ( P = .02 ) .\
RESULTS	The ACO at 3 months was grade 2 in 44 % of eyes in Group A and in 61 % in Group B ( P = .13 ) .\
CONCLUSIONS	Aspiration of LECs from the anterior capsule was a safe procedure that reduced capsulorhexis aperture contraction 3 months after cataract surgery .\
\
###15847950\
BACKGROUND	This study aims to investigate the efficacy of fluoxetine and paroxetine on the levels of depression-anxiety , quality of life , disability , and metabolic control in type II diabetes mellitus ( DM ) patients .\
METHODS	The patients were first applied the Hospital Anxiety-Depression Scale ( HADS ) .\
METHODS	After a psychiatric interview with patients who had scores above the cut-off point , those who were diagnosed as having a major depressive disorder according to DSM-IV criteria were applied the Hamilton Depression Rating Scale ( HDRS ) and the Hamilton Anxiety Rating Scale ( HARS ) .\
METHODS	Twenty three patients who scored 16 or above on the HDRS were included in the study and given the Short Form-36 ( SF-36 ) , and the Brief Disability Questionnaire ( BDQ ) and HbA1c levels were measured .\
METHODS	Patients were randomized on 20 mg/day fluoxetine or 20 mg/day paroxetine treatment .\
METHODS	The patients were evaluated with the same scales at the 2 ( nd ) , 4 ( th ) , 6 ( th ) , and the 12 ( th ) weeks .\
RESULTS	Both groups showed a statistically significant decrease in HDRS , HARS , and BDQ scores with comparison to the index assessment .\
RESULTS	At the end of treatment , though not statistically significant , a decrease was observed in HbA1c values of the fluoxetine-administered group .\
CONCLUSIONS	Fluoxetine and paroxetine effectively reduce the severity of major depressive disorder in type II DM patients .\
CONCLUSIONS	There is need for further and longer-lasting monitoring studies with more patients in order to determine whether there is any difference in terms of their effects on glycemic control .\
\
###14705152\
OBJECTIVE	Selective serotonin reuptake inhibitor ( SSRI ) medication does not appear to be effective in ill , malnourished anorexia nervosa ( AN ) patients .\
OBJECTIVE	However , it may be effective in preventing relapse after weight restoration .\
OBJECTIVE	The purpose of this study was to determine whether nutritional supplements could potentiate the effects of fluoxetine in underweight AN subjects .\
METHODS	Twenty-six subjects with AN participated in a trial of fluoxetine .\
METHODS	In a double-blind , placebo-controlled manner , subjects received either nutritional supplements or a nutritional placebo .\
METHODS	The nutritional supplement included tryptophan ( the precursor of serotonin ) , vitamins , minerals , and essential fatty acids believed to influence serotonin pathway function .\
RESULTS	There was no significant difference in weight gain between subjects treated with fluoxetine plus nutritional supplements versus fluoxetine plus a nutritional placebo .\
RESULTS	Moreover , there were no significant differences between groups on mean changes in anxiety or obsessive and compulsive symptoms .\
CONCLUSIONS	The results of this study suggest that supplement strategies are not a substitute for adequate nutrition and are ineffective in increasing the efficacy of fluoxetine in underweight AN subjects .\
\
###11782332\
OBJECTIVE	The use of opioids in labour analgesia has primarily been as an adjuvant to local anesthetics .\
OBJECTIVE	For early labour , satisfactory analgesia with epidural sufentanil alone is possible .\
OBJECTIVE	This study evaluates the impact of epinephrine on sedative side effects and analgesia related to the latter technique .\
METHODS	After Institutional Review Board approval and informed consent this prospective , randomized , double-blind study evaluated 43 nulliparous subjects requesting epidural analgesia .\
METHODS	The study site , a tertiary care obstetric unit , accommodates 3500-4500 deliveries annually .\
METHODS	Group selection was randomized and blinded by selection of a sealed envelope containing a number which corresponded to a premixed labelled syringe of saline or epinephrine ( 100 microg/mL ) .\
METHODS	An epidural catheter was placed in a standardized fashion .\
METHODS	All subjects received 40 microg of sufentanil and 0.5 mL from the premixed syringe , diluted to 10 mL with NaCl .\
METHODS	A blinded observer collected data on maternal sedation , lightheadedness , hemodynamics , oxygenation , and fetal heart rate over a one-hour period following sufentanil injection .\
RESULTS	The addition of epinephrine significantly ( P < 0.05 ) reduced the incidence of sedation and lightheadedness after epidural sufentanil at all data collection points , except two .\
RESULTS	Analgesic duration was also significantly prolonged by this addition ( 120 + / - 56 vs 84 + / - 32 min ) .\
RESULTS	Maternal satisfaction was high regardless of solution .\
CONCLUSIONS	Forty micrograms of epidural sufentanil produces satisfactory analgesia in early labour .\
CONCLUSIONS	The addition of epinephrine improves the side effect profile of this technique while prolonging the duration of analgesia .\
CONCLUSIONS	Epidural sufentanil requires attention to maternal monitoring of oxygenation as maternal desaturation occurred in both groups .\
\
###19320679\
OBJECTIVE	Remote delivery of interventions is needed to address large numbers of people with alcohol use disorders who are spread over large areas .\
OBJECTIVE	Previous correspondence trials typically examined its effects as stand-alone treatment .\
OBJECTIVE	This study aimed to test whether adding postal treatment to general practitioner ( GP ) support would lower alcohol use more than GP intervention alone .\
METHODS	A single-blind , randomised controlled trial with a crossover design was conducted over 12 months on 204 people with alcohol use disorders .\
METHODS	Participants in an immediate correspondence condition received treatment over the first 3 months ; those receiving delayed treatment received it in months 3-6 .\
RESULTS	Few participants were referred from GPs , and little intervention was offered by them .\
RESULTS	At 3 months , 78 % of participants remained in the study .\
RESULTS	Those in immediate treatment showed greater reductions in alcohol per week , drinking days , anxiety , depression and distress than those in the delayed condition .\
RESULTS	However , post-treatment and follow-up outcomes still showed elevated alcohol use , depression , anxiety and distress .\
RESULTS	Greater baseline anxiety predicted better alcohol outcomes , although more mental distress at baseline predicted dropout .\
CONCLUSIONS	The study gave consistent results with those from previous research on correspondence treatments , and showed that high levels of participant engagement over 3 months can be obtained .\
CONCLUSIONS	Substantial reductions in alcohol use are seen , with indications that they are well maintained .\
CONCLUSIONS	However , many participants continue to show high-risk alcohol use and psychological distress .\
\
###24620839\
OBJECTIVE	This study is an analysis of the pre-trial quality assurance ( QA ) exercises submitted by clinicians from radiotherapy ( RT ) centres across Europe and Canada to qualify for participation in the CONVERT trial .\
METHODS	QA exercises submitted by 64 clinicians at 64 RT centres were included in this analysis .\
METHODS	The exercises included the completion of a trial-specific questionnaire and submission of a treatment plan , for both trial arms , for a patient fitting the eligibility criteria of the trial .\
METHODS	This article describes the QA programme set up for the CONVERT trial and identifies deviations from the trial protocol .\
METHODS	Patient eligibility , disease and critical structure outlining and treatment planning technique were assessed .\
RESULTS	Results from QA trial-specific questionnaires received between February 2008 and September 2011 , returned as part of the QA exercise , indicated that the majority of centres ( 70.3 % ) were using 6-MV photons and type B treatment planning system algorithms ( 57.8 % ) .\
RESULTS	90.6 % of clinicians assessed submitted data for patients who fitted the eligibility criteria for the trial .\
RESULTS	There were inconsistencies in outlining of gross tumour volume ( GTV ) and organs at risk , mainly heart and oesophagus , and in the use of margins around the GTV .\
CONCLUSIONS	Such a QA programme helps to ensure that centres conform to trial protocol and should reduce inconsistencies in RT planning that may confound the results of the CONVERT trial .\
CONCLUSIONS	Few studies reporting pre-trial QA have been published to date .\
CONCLUSIONS	This article outlines the importance of such a QA programme in the context of multicentre Phase III studies .\
\
###17380548\
BACKGROUND	The optimal colloid for renal protection during abdominal aortic aneurysm ( AAA ) surgery is not known .\
BACKGROUND	This study compared the effects of two hydroxyethyl starch ( HES ) solutions and gelatine on perioperative renal function .\
METHODS	Sixty-two patients undergoing AAA surgery were randomized to 6 per cent HES of molecular weight 200/0 .62 kDa or 130/0 .4 kDa , or 4 per cent gelatine for plasma expansion .\
METHODS	Measurements were taken of serum urea and creatinine to mark glomerular filtration , urinary immunoglobulin G : creatinine ratio to mark glomerular membrane function and alpha ( 1 ) - microglobulin : creatinine ratio to mark tubular dysfunction before , and for 5 days after , surgery .\
RESULTS	Serum urea was lower in both HES groups than the gelatine group .\
RESULTS	Serum creatinine was lower with HES 130/0 .4 compared with gelatine at days 1 , 2 and 5 after surgery ( P = 0.020 , P = 0.045 and P = 0.045 respectively ) .\
RESULTS	Urinary alpha ( 1 ) - microglobulin : creatinine ratio was lower with HES 200/0 .62 compared with gelatine at 4 and 8 h ( P < 0.050 ) and lower with HES 130/0 .4 compared with gelatine at 4 to 24 h , and on days 4 and 5 ( P < 0.050 ) .\
RESULTS	Urinary immunoglobulin G : creatinine was lower in both HES groups compared with gelatine .\
RESULTS	There was no difference between the two starch groups .\
CONCLUSIONS	Compared with gelatine , volume expansion with both types of HES during AAA surgery improved renal function and reduced renal injury .\
\
###20723926\
OBJECTIVE	Androgen deprivation therapy is associated with fracture risk in men with prostate cancer .\
OBJECTIVE	We assessed the effects of toremifene , a selective estrogen receptor modulator , on fracture incidence in men receiving androgen deprivation therapy during a 2-year period .\
METHODS	In this double-blind , placebo controlled phase III study 646 men receiving androgen deprivation therapy for prostate cancer were assigned to toremifene ( 80 mg by mouth daily ) and 638 were assigned to placebo .\
METHODS	Subjects were followed for 2 years .\
METHODS	The primary study end point was new vertebral fractures .\
METHODS	Secondary end points included fragility fractures , bone mineral density and lipid changes .\
RESULTS	The 2-year incidence of new vertebral fractures was 4.9 % in the placebo group vs 2.5 % in the toremifene group , a significant relative risk reduction of 50 % ( 95 % CI -1.5 to 75.0 , p = 0.05 ) .\
RESULTS	Toremifene significantly increased bone mineral density at the lumbar spine , hip and femoral neck vs placebo ( p < 0.0001 for all comparisons ) .\
RESULTS	There was a concomitant decrease in markers of bone turnover ( p < 0.05 for all comparisons ) .\
RESULTS	Toremifene also significantly improved lipid profiles .\
RESULTS	Venous thromboembolic events occurred more frequently with toremifene than placebo with 7 subjects ( 1.1 % ) in the placebo group experiencing a venous thromboembolic event vs 17 ( 2.6 % ) in the toremifene group .\
RESULTS	Other adverse events were similar between the groups .\
CONCLUSIONS	Toremifene significantly decreased the incidence of new vertebral fractures in men receiving androgen deprivation therapy for prostate cancer .\
CONCLUSIONS	It also significantly improved bone mineral density , bone turnover markers and serum lipid profiles .\
\
###18999909\
OBJECTIVE	To study the medical service utilization changes and return on investment from a health plan 's direct mailings that either encouraged members to receive influenza vaccinations or encouraged members to call a nurse advice service .\
METHODS	Randomized controlled trial with 2 intervention groups and 1 control group consisting of all members over age 65 years who were enrolled in 5 states in the Blue Cross and Blue Shield Government-wide Service Benefit Plan .\
METHODS	Sample size was 134,791 individuals .\
METHODS	Administrative claims-based influenza , pneumonia , heart failure , and respiratory inpatient bed days , emergency department ( ED ) visits , physician evaluation and management visits , other outpatient visits , and nurse advice call rates were compared between the intervention and control groups .\
RESULTS	The influenza mailing intervention group experienced 2.87 % ( P = .033 ) fewer conditionrelated inpatient bed days and 7.25 % ( P = .101 ) fewer condition-related ED visits .\
RESULTS	The nurse advice service mailing intervention group experienced 7.65 % ( P < .001 ) fewer condition-related inpatient bed days and 6.75 % ( P = .125 ) fewer condition-related ED visits .\
RESULTS	Per dollar spent , the return on investment was estimated to be $ 2.51 for the influenza mailing intervention and $ 24.24 for the nurse advice mailing intervention .\
CONCLUSIONS	Administrative claims data suggest that members respond to health plan mailings .\
CONCLUSIONS	By mailing information to their members , health plans can affect rates of medical service utilization and generate cost savings .\
\
###14600695\
OBJECTIVE	To study human pulp reactions to direct cappings with a dentin adhesive compared with a calcium hydroxide cement , especially with respect to formation of hard tissue in the exposure site .\
METHODS	Direct pulp cappings were made in 34 caries-free premolars scheduled for extraction due to orthodontic treatment .\
METHODS	Half of the teeth were capped with a dentin adhesive , the other half with a calcium hydroxide cement .\
METHODS	After periods of from 7 to 70 days , the teeth were extracted and processed for light microscopical examination .\
RESULTS	No postoperative sensitivity was experienced .\
RESULTS	A slight inflammatory reaction was seen in both groups in the short observation period .\
RESULTS	In the long observation period , significantly more `` dentin bridging '' was seen in the calcium hydroxide group than in the dentin adhesive group ( P < .05 ) .\
CONCLUSIONS	The findings from the present limited material is in accordance with previous findings from human studies and contraindicate use of dentin adhesives for direct pulp capping .\
\
###24275612\
BACKGROUND	Recently , there have been investigations that have targeted improving the relatively poor validity and reliability of attentional bias measures .\
BACKGROUND	These studies have demonstrated that individuals show elevated attentional bias to stimuli associated with their drinking history , although to date , the predictive utility of these measures has yet to be assessed .\
BACKGROUND	The current study aimed to investigate the predictive value of an individualised alcohol Stroop task compared to that of an alcohol Stroop task with general alcohol-related words in a sample of non-dependent undergraduate drinkers .\
METHODS	48 undergraduate social drinkers completed questionnaire measures of alcohol consumption and hazardous drinking which were combined to get an alcohol involvement measure .\
METHODS	Participants also completed three blocked format Stroop tasks , a control Stroop ( containing soft drink-related words ) , a general alcohol Stroop ( containing a mixture of alcohol-related words ) and an individualised Stroop that contained words relating to the participants ' favourite alcoholic drink .\
RESULTS	Although there was no significant difference in participants ' performance across the three different Stroop tasks , only performance on the individualised Stroop was associated with alcohol involvement .\
RESULTS	Notably , the individualised Stroop predicted variance in drinking after controlling for demographics and general alcohol Stroop performance .\
CONCLUSIONS	This study indicates that adopting individualised stimuli into attentional bias tasks may increase their predictive validity .\
\
###20403303\
OBJECTIVE	To evaluate fissure sealants based on Bis-GMA [ Fissurit F ( FF ) and Fissurit FX ( FFX ) ] , compomer [ Dyract Seal ( DS ) ] and ormocer [ Admira Seal ( AS ) ] with respect to retention , marginal integrity and presence of caries after a 2-year period of follow-up .\
METHODS	80 children aged 7-13 years ( mean age : 9.4 + 1.3 years ) , were included , giving a total of 320 first permanent molars for the study units .\
METHODS	Clinical evaluation of the sealants was carried out to assess retention , marginal integrity and presence of caries at 12 and 24 months after initial treatment .\
RESULTS	Retention of compomer-based DS sealant was significantly lower than that of the others at the 12 - and 24-month follow-up examinations ( 12 month , P < 0.000 ; 24 month , P < 0.006 ) .\
RESULTS	No significant differences between the sealants were observed in marginal integrity ( 12 month , P > 0.473 ; 24 month , P > 0.069 ) or presence of caries ( 12 month , P > 0.055 ; 24 month , P > 0.777 ) at any follow-up examination .\
CONCLUSIONS	While sealants composed of different resin matrices showed differences in retention , they were similar with respect to marginal integrity and presence of caries .\
CONCLUSIONS	Surface conditioning and the organic structure of the material are factors that may affect sealant retention .\
\
###17568589\
OBJECTIVE	Endothelial activation and dysfunction may be an important contributor to chronic heart failure ( CHF ) progression .\
OBJECTIVE	We sought to investigate whether the calcium sensitizer levosimendan affects beneficially endothelial function and attenuates the deleterious effects of soluble adhesion molecules in patients with advanced CHF .\
METHODS	Twenty-six advanced CHF patients ( mean New York Heart Association class , 2.6 + / -0.3 ; ischemic/dilated , 18/8 ; mean left ventricular ejection fraction < 35 % ) hospitalized due to syndrome worsening , were randomized ( 2:1 ) to receive either a 24-h levosimendan infusion of 0.1 microg/kg/min ( n = 17 ) or placebo ( n = 9 ) .\
METHODS	Endothelial function estimated by endothelial-dependent flow-mediated dilatation of the brachial artery ( FMD ) , as well as plasma soluble intercellular adhesion molecule-1 ( sICAM-1 ) and soluble vascular cell adhesion molecule-1 ( sVCAM-1 ) , were assessed before and 48 h after therapy .\
RESULTS	Baseline characteristics and medications were well balanced in the two treatment groups .\
RESULTS	A significant improvement of FMD ( 6.4 + / -4.4 % from 4.8 + / -3.0 % ; p < 0.05 ) with concomitant reduction of plasma concentrations of sICAM-1 ( 231 + / -75 pg/ml from 339 + / -157 pg/ml ; p < 0.05 ) and sVCAM-1 ( 1134 + / -508 pg/ml from 1386 + / -602 pg/ml ; p < 0.05 ) were observed only in levosimendan treated patients .\
CONCLUSIONS	Levosimendan could be an effective treatment in improving the endothelial function and reducing the detrimental adhesion molecule activation in advanced CHF patients .\
\
###15114377\
OBJECTIVE	To study the calcium homeostasis in healthy , calcium and vitamin D replete early postmenopausal women during oral supplementation with calcium and vitamin D3 .\
METHODS	A prospective , placebo-controlled , randomised , double-single-blind , 3-week study .\
METHODS	Outpatient clinic at Copenhagen University Hospital , Denmark .\
METHODS	In all , 17 started , one was excluded .\
METHODS	Totally , 16 healthy women , 45-61 y of age ( mean 57.3 y ) who were at least 4 y after menopause ( mean 6.7 y ) completed .\
METHODS	All underwent three consecutive 7-day study periods .\
METHODS	Each began with 4 days of normal diet followed by 3 days treatment of either C : one tablet of 1.250 mg calcium carbonate ( ie 500 mg Ca2 + per tablet ) twice daily ( breakfast and dinner ) , or CD3 : as in C but plus 400 IU vitamin D3 b.i.d. , or P ( only ) placebo tablets b.i.d.\
RESULTS	At baseline plasma 25-hydroxycholecalciferol was normal ( 66 + / -22 nmol/l ) and the calcium intake without supplements 850 mg/day .\
RESULTS	In group C , the 24-h urinary calcium increased by 35 % ( 6.9 + / -2.0 mmol ) , vs the placebo group P ( 5.1 + / -1.6 mmol ) ( P < 0.05 ) .\
RESULTS	Addition of 800 IU vitamin D3 daily ( CD3 ) did not increase calcium excretion further ( 6.6 + / -2.1 mmol ) but decreased plasma 1,25 - ( OH ) 2-vitamin D3 by 21 % ( P < 0.05 ) .\
CONCLUSIONS	In this carefully controlled study calcium plus vitamin D3 supplements only had minor influences of uncertain significance on the calcium balance in healthy , calcium and vitamin D sufficient early postmenopausal women .\
\
###23725973\
BACKGROUND	In peritoneal dialysis , the high glucose load absorbed from dialysis fluid contributes to several metabolic abnormalities , including insulin resistance .\
BACKGROUND	We evaluate the efficacy of a peritoneal dialysis solution containing l-carnitine as an additive to improve insulin sensitivity .\
METHODS	Multicenter parallel randomized controlled trial .\
METHODS	Nondiabetic uremic patients on continuous ambulatory peritoneal dialysis enrolled in 8 peritoneal dialysis centers .\
METHODS	Patients were randomly assigned to receive peritoneal dialysis diurnal exchanges with either a standard glucose-based solution ( 1.5 % or 2.5 % according to the patient 's need ) or a glucose-based solution ( identical glucose amount ) enriched with l-carnitine ( 0.1 % , weight/volume ; 2 g/bag ) for 4 months , the nocturnal exchange with icodextrin being unmodified .\
METHODS	The primary outcome was insulin sensitivity , measured by the magnitude of change from baseline in glucose infusion rate ( in milligrams per kilogram of body weight per minute ) during a euglycemic hyperinsulinemic clamp .\
METHODS	Secondary outcomes were safety and tolerability , body fluid management , peritoneal dialysis efficiency parameters , and biochemistry tests .\
RESULTS	35 patients were randomly assigned , whereas 27 patients ( standard solution , n = 12 ; experimental solution , n = 15 ) were analyzed .\
RESULTS	Adverse events were not attributable to treatment .\
RESULTS	Glucose infusion rates in the l-carnitine-treated group increased from 3.8 2.0 ( SD ) mg/kg/min at baseline to 5.0 2.2 mg/kg/min at day 120 ( P = 0.03 ) compared with 4.8 2.4 mg/kg/min at baseline and 4.7 2.4 mg/kg/min at day 120 observed in the control group ( P = 0.8 ) .\
RESULTS	The difference in glucose infusion rates between groups was 1.3 ( 95 % CI , 0.0-2 .6 ) mg/kg/min .\
RESULTS	In patients treated with l-carnitine-containing solution , urine volume did not change significantly ( P = 0.1 ) compared to a significant diuresis reduction found in the other group ( P = 0.02 ) .\
RESULTS	For peritoneal function , no differences were observed during the observation period .\
CONCLUSIONS	Small sample size .\
CONCLUSIONS	The use of l-carnitine in dialysis solutions may represent a new approach to improving insulin sensitivity in nondiabetic peritoneal dialysis patients .\
\
###18264616\
OBJECTIVE	To evaluate the effectiveness of an integrated infant and young child feeding counseling course for transforming the knowledge , attitudes and practices of pediatricians and nutritionists working for the municipal health system of So Paulo , Brazil .\
METHODS	A randomized intervention study enrolling 29 professionals in the intervention group and 27 in the control group .\
METHODS	Interviewers were trained in advance to collect data on the professionals working at health centers , before and 2 months after the intervention .\
METHODS	Three research instruments were used , the first was to assess the profile of each professional , the second assessed their knowledge and the third was a clinical observation protocol .\
METHODS	Analysis was performed using the Kruskal-Wallis test for independent samples and the Tukey method .\
RESULTS	The results for the knowledge questionnaire showed improvements in the intervention group ( p < 0.001 ) for the whole questionnaire and for questions on breastfeeding ( p = 0.004 ) ; HIV and infant and young child feeding ( p = 0.049 ) ; complementary feeding ( p = 0.012 ) ; and counseling in infant and young child feeding ( p = 0.004 ) .\
RESULTS	In terms of performance , it was observed that the intervention group had significantly improved their dietary anamnesis after the intervention ( p < 0.001 ) .\
CONCLUSIONS	This course effectively promoted an increase in knowledge and improvements in dietary anamnesis performance , but the same was not true of counseling skills .\
\
###16409530\
BACKGROUND	Prevention of postoperative pain in children is one of the most important objectives of the anesthesiologist .\
BACKGROUND	Preoperative ilioinguinal and iliohypogastric nerve blocks have been widely used to provide analgesia in children undergoing herniorrhaphy .\
BACKGROUND	Tramadol is an analgesic with micro-opioid and nonopioid activity .\
BACKGROUND	In this study we compared the usage of intravenous tramadol with ilioinguinal and iliohypogastric nerve blocks for control of post-herniorrhaphy pain in children aged 2-7 years .\
METHODS	Sixty patients were randomly allocated to two groups of thirty .\
METHODS	One group received tramadol 1.5 mg.kg ( -1 ) i.v. before induction of general anesthesia and the other had an ilioinguinal and iliohypogastric nerve block with 0.5 % bupivacaine ( 0.25 ml.kg ( -1 ) ) before skin incision .\
METHODS	We assessed pain using the Children 's Hospital of Eastern Ontario Pain Scale and the Categorical Pain Scale .\
RESULTS	At 1 , 4 and 24 h after surgery the two groups had identical pain scores .\
RESULTS	At 2 and 3 h after surgery the tramadol group experienced significantly less pain ( P < 0.05 ) .\
RESULTS	The rescue drug for residual pain , was used equally in the two groups .\
RESULTS	None of the 60 patients had respiratory depression but the tramadol group patients were found to have more episodes of nausea and vomiting ( P < 0.05 ) .\
CONCLUSIONS	We concluded that tramadol can have at least the same analgesic effect as that of ilioinguinal and iliohypogastric nerve blocks for post-herniorrhaphy pain in children , with even a superior effect at the time of maximal analgesia .\
CONCLUSIONS	We also highlight the troublesome side-effect of nausea and vomiting which brings into question the benefits of using this opioid that seems to lack respiratory depression .\
\
###19486260\
BACKGROUND	Epidemiologic and experimental studies suggest that higher intake of dairy products could be associated with lower risk of hypertension and obesity .\
BACKGROUND	Differences in nutrient composition of distinct dairy products suggest that their effect on these outcomes might be heterogeneous .\
BACKGROUND	However , little experimental research has examined the potentially different effects of low - and whole-fat dairy products on blood pressure ( BP ) and weight change .\
BACKGROUND	The present study aimed to assess whether supplementing diets with low - or whole-fat dairy products would differentially affect BP levels and weight .\
METHODS	A randomised crossover trial in 45 normotensive volunteers ( 18-24 years old , 49 % female ) was conducted .\
METHODS	Participants alternatively received 3.5 servings/day of whole-fat or low-fat dairy products ( milk and yogurt ) in addition to their usual diet during two 8-week periods , with a 4-week washout period between both interventions .\
METHODS	Weight and BP were measured at the beginning and end of each intervention .\
RESULTS	Whole-fat dairy supplementation significantly increased systolic BP [ 2.1 mmHg , 95 % confidence interval ( CI ) = 0.1-4 .0 , P = 0.04 ] and weight ( 1.0 kg , 95 % CI = 0.5-1 .5 , P = 0.0002 ) , but not diastolic BP ( P = 0.34 ) .\
RESULTS	Weight and BP did not change significantly after the low-fat dairy intervention ( P > 0.10 ) .\
RESULTS	There were no significant differences in the effect of low-fat or whole-fat dairy products on BP ( P > 0.60 ) , but whole-fat dairy increased weight significantly compared to low-fat dairy ( 1.2 kg , 95 % CI = 0.5-1 .8 , P = 0.0007 ) .\
CONCLUSIONS	In a young nonhypertensive population , dietary supplementation with whole-fat dairy products , compared to low-fat dairy , was associated with weight gain .\
CONCLUSIONS	No differential effects were observed for levels of BP .\
\
###25607117\
BACKGROUND	Anesthesiologists use various medications to provide surgical patients with pain relief in the postoperative period .\
BACKGROUND	Other modalities , such as music , could be used in conjunction with opioids and nonsteroidal anti-inflammatory drugs ( NSAIDs ) to decrease pain and lower heart rate and blood pressure .\
BACKGROUND	Our hypothesis was that patients listening to jazz in a postanesthesia care unit ( PACU ) would have lower heart rates and blood pressures and reduced pain and anxiety .\
OBJECTIVE	The study objective was to determine if listening to jazz music in the PACU , when compared to wearing noise-canceling headphones with no music playing , would decrease heart rate , blood pressure , pain , or anxiety in patients undergoing a hysterectomy .\
METHODS	The research design was a prospective , randomized study .\
METHODS	The study was conducted in the PACU at the Penn State Hershey Medical Center in Hershey , PA , USA .\
METHODS	A total of 56 patients , aged 18-75 y , who were categorized as status 1 or 2 according to the American Society of Anesthesiologists ( ASA ) Physical Status Classification System , and who were undergoing elective laparoscopic or abdominal hysterectomies , were enrolled in the study .\
METHODS	Patients were randomly assigned either to listen to jazz music where the beats per min ( BPM ) was < 100 ( experimental group , n = 28 ) or to wear noise-canceling headphones ( control group , n = 28 ) for 30 min while in the PACU after their surgery .\
METHODS	Heart rate was the primary outcome , and secondary outcomes included systolic and diastolic blood pressure , an anxiety score , and a pain score .\
METHODS	All outcome measures were initially recorded at baseline upon the patient 's arrival in the PACU .\
METHODS	Heart rate and blood pressure were recorded postoperatively every 5 min for the initial 30 min that a patient was in the PACU .\
METHODS	Pain was checked every 10 min during the 30-min period ; anxiety was checked at 30 min .\
RESULTS	Heart rates of patients in the noise-cancellation group were significantly lower when compared with baseline ( P < .05 ) , at all time points .\
RESULTS	For patients in the jazz group , heart rates were significantly lower at 15 , 20 , 25 , and 30 min when compared with baseline .\
RESULTS	The pain scores were significantly lower ( P < .05 ) in the noise-cancellation group compared with the jazz group at 10 min into the recovery period .\
CONCLUSIONS	Overall , the results showed that patients responded not only to music but also to silence in the PACU .\
CONCLUSIONS	Using music and/or noise reduction could decrease opioid administration , promote relaxation , and improve patient satisfaction .\
\
###23521470\
OBJECTIVE	Radiation exposure to interventionalists is increasing .\
OBJECTIVE	The currently available standard radiation protection devices are heavy and do not protect the head of the operator .\
OBJECTIVE	The aim of this study was to evaluate the effectiveness and comfort of caps and thyroid collars made of a disposable , light-weight , lead-free material ( XPF ) for occupational radiation protection in a clinical setting .\
METHODS	Up to two interventional operators were randomized to wear a XPF or standard 0.5-mm lead-equivalent thyroid collars in 60 consecutive endovascular procedures requiring fluoroscopy .\
METHODS	Simultaneously a XPF cap was worn by all operators .\
METHODS	Radiation doses were measured using dosimeters placed outside and underneath the caps and thyroid collars .\
METHODS	Wearing comfort was assessed at the end of each procedure on a visual analog scale ( 0-100 [ 100 = optimal ] ) .\
RESULTS	Patient and procedure data did not differ between the XPF and standard protection groups .\
RESULTS	The cumulative radiation dose measured outside the cap was 15,700 Sv and outside the thyroid collars 21,240 Sv .\
RESULTS	Measured radiation attenuation provided by the XPF caps ( n = 70 ) , XPF thyroid collars ( n = 40 ) , and standard thyroid collars ( n = 38 ) was 85.4 % 25.6 % , 79.7 % 25.8 % and 71.9 % 34.2 % , respectively ( mean difference XPF vs standard thyroid collars , 7.8 % [ 95 % CI , -5.9 % to 21.6 % ] ; p = 0.258 ) .\
RESULTS	The median XPF cap weight was 144 g ( interquartile range , 128-170 g ) , and the XPF thyroid collars were 27 % lighter than the standard thyroid collars ( p < 0.0001 ) .\
RESULTS	Operators rated the comfort of all devices as high ( mean scores for XPF caps and XPF thyroid collars 83.4 12.7 ( SD ) and 88.5 14.6 , respectively ; mean scores for standard thyroid collars 89.6 9.9 ) ( p = 0.648 ) .\
CONCLUSIONS	Light-weight disposable caps and thyroid collars made of XPF were assessed as being comfortable to wear , and they provide radiation protection similar to that of standard 0.5-mm lead-equivalent thyroid collars .\
\
###20980485\
BACKGROUND	There is a paucity of research evaluating the relation between vitamin D and recurrence of breast cancer after treatment .\
OBJECTIVE	This study was designed to evaluate the associations between circulating concentrations of 25-hydroxyvitamin D [ 25 ( OH ) D ] and dietary , supplemental , and total intake of vitamin D and recurrent or new breast cancer events within the Women 's Healthy Eating and Living ( WHEL ) Study .\
METHODS	A prospective cohort study design ( n = 3085 ) was used to evaluate the relation between dietary , supplemental , and total vitamin D intake and recurrent breast cancer , and a nested case-control study with 512 matched pairs was used for analysis of the association between 25 ( OH ) D and breast cancer recurrence .\
RESULTS	No relation between 25 ( OH ) D and breast cancer recurrence was observed .\
RESULTS	Compared with women with serum concentrations of 25 ( OH ) D 30 ng/mL , adjusted odds ratios ( 95 % CI ) for breast cancer recurrence were 1.14 ( 0.57 , 2.31 ) for those with concentrations < 10 ng/mL , 1.00 ( 0.68-1 .48 ) for concentrations 10 and < 20 ng/mL , and 1.05 ( 0.76 , 1.47 ) for concentrations 20 and < 30 ng/mL .\
RESULTS	No significant associations were observed when analyses were stratified by pre - and postmenopausal status or for local , regional , or distant recurrence or death .\
RESULTS	Vitamin D intake was not related to breast cancer recurrence overall , although for premenopausal women there was a significant inverse association between dietary vitamin D intake and recurrence ( P for trend = 0.02 ) .\
CONCLUSIONS	These results do not provide support for a relation between concentrations of 25 ( OH ) D after treatment and the recurrence of breast cancer .\
CONCLUSIONS	This trial is registered at clinicaltrials.gov for the WHEL Study as NCT00003787 .\
\
###23254945\
BACKGROUND	Perioperative hemorrhage and postoperative bile leakage are severe complications of liver surgery .\
BACKGROUND	They may be related to the techniques used to divide the tissue .\
BACKGROUND	We designed a randomized clinical trial to compare the cavitron ultrasonic surgical aspirator ( CUSA ) and an endoscopic stapler device applied in routine clinical hepatic surgical practice .\
METHODS	All consecutive patients admitted for elective hepatic resective surgery -- at least bisegmentectomy of the liver -- were assessed for enrollment in the study .\
METHODS	A total of 100 patients were subsequently randomized .\
METHODS	There was a good balance between the study groups concerning issues that may be of relevance for the perioperative and postoperative courses .\
METHODS	The primary objective of the study was to achieve an approximately 25 % reduction in perioperative blood loss and postoperative bile leakage .\
METHODS	Secondary outcome variables were operating time , general postoperative morbidity , length of hospital stay , and direct medical costs .\
RESULTS	The amount of perioperative or postoperative blood loss did not differ significantly between the two groups .\
RESULTS	We observed a trend toward shorter transection and operating time for patients in whom staplers were used , but the difference did not reach statistical significance .\
RESULTS	The postoperative courses were close to identical in the respective study arms with no difference in bile leakage rates or in the total morbidity profiles .\
RESULTS	The direct medical costs were nonsignificantly lower in the group where staplers were used for liver transection .\
CONCLUSIONS	The results show that the use of endoscopic vascular staplers in liver surgery is feasible and safe .\
CONCLUSIONS	It offers an attractive alternative for division of the liver parenchyma during routine hepatic surgery , being comparable to the use of CUSA without adding extra costs .\
\
###24262616\
OBJECTIVE	The aim of the study was to compare long-term follow-up results of crush versus culotte stent techniques in coronary bifurcation lesions .\
BACKGROUND	The randomized Nordic Stent Technique Study showed similar 6-month clinical and 8-month angiographic results with the crush and culotte stent techniques of de novo coronary artery bifurcation lesions using sirolimus-eluting stents .\
BACKGROUND	Here , we report the 36-month efficacy and safety of the Nordic Stent Technique Study .\
METHODS	A total of 424 patients with a bifurcation lesion were randomized to stenting of both main vessel and side branch with the crush or the culotte technique and followed for 36 months .\
METHODS	Major adverse cardiac events-the composite of cardiac death , myocardial infarction , stent thrombosis , ortarget vessel revascularization-were the primary endpoint .\
RESULTS	Follow-up was complete for all patients .\
RESULTS	At 36 months , the rates of the primary endpoint were 20.6 % versus 16.7 % ( p = 0.32 ) , index lesion restenosis 11.5 % versus 6.5 % ( p = 0.09 ) , and definitestent thrombosis 1.4 % versus 4.7 % ( p = 0.09 ) in the crush and the culotte groups , respectively .\
CONCLUSIONS	At 36-month follow-up , the clinical outcomes were similar for patients with coronary bifurcation lesions treated with the culotte or the crush stent technique .\
CONCLUSIONS	( Nordic Bifurcation Study .\
CONCLUSIONS	How to Use Drug Eluting Stents [ DES ] in Bifurcation Lesions ?\
CONCLUSIONS	NCT00376571 ) .\
\
###17503976\
OBJECTIVE	This study evaluated the efficacy and safety of desvenlafaxine succinate extended-release in major depressive disorder ( MDD ) .\
METHODS	Adult outpatients with DSM-IV-defined MDD were randomly assigned to desvenlafaxine 100 mg/day ( N = 114 ) , 200 mg/day ( N = 116 ) , or 400 mg/day ( N = 113 ) or placebo ( N = 118 ) for 8 weeks .\
METHODS	Efficacy variables included change from baseline in the 17-item Hamilton Rating Scale for Depression ( HAM-D ( 17 ) , the primary efficacy measure ) , Clinical Global Impressions-Improvement scale ( CGI-I ) , Montgomery-Asberg Depression Rating Scale , Clinical Global Impressions-Severity of Illness scale ( CGI-S ) , rates of response ( > or = 50 % decrease from baseline HAM-D ( 17 ) score ) and remission ( HAM-D ( 17 ) score < or = 7 ) , and Visual Analog Scale-Pain Intensity overall score .\
METHODS	The study was conducted from November 2003 to November 2004 .\
RESULTS	At the final on-therapy evaluation , the mean HAM-D ( 17 ) scores for desvenlafaxine 100 mg/day ( 12.75 ) and 400 mg/day ( 12.50 ) were significantly lower than for placebo ( 15.31 ; p = .0038 and p = .0023 , respectively ) ; for desvenlafaxine 200 mg/day , the mean score was 13.31 ( p = .0764 ) .\
RESULTS	CGI-I and Montgomery-Asberg Depression Rating Scale results were significant for all groups ; CGI-S results were significant with 100 mg/day and 400 mg/day .\
RESULTS	Response rates were significantly greater for desven-lafaxine 100 mg/day ( 51 % ) and 400 mg/day ( 48 % ) versus placebo ( 35 % ; p = .017 and p = .046 , respectively ) ; the response rate for desvenlafaxine 200 mg/day was 45 % ( p = .142 ) .\
RESULTS	Remission rates were significantly greater for desvenlafaxine 400 mg/day ( 32 % ) versus placebo ( 19 % ; p = .035 ) ; remission rates were 30 % for desvenlafaxine 100 mg/day ( p = .093 ) and 28 % for desvenlafaxine 200 mg/day ( p = .126 ) .\
RESULTS	Visual Analog Scale-Pain Intensity results were significant for desvenlafaxine 100 mg/day versus placebo ( p = .002 ) , but not for the higher doses .\
RESULTS	The most commonly reported adverse events were nausea , insomnia , somnolence , dry mouth , dizziness , sweating , nervousness , anorexia , constipation , asthenia , and abnormal ejaculation/orgasm .\
CONCLUSIONS	Desvenlafaxine is effective and well tolerated in the short-term treatment of MDD .\
\
###23298790\
OBJECTIVE	To compare the therapeutic effect of low - and high-frequency repetitive transcranial magnetic stimulation ( rTMS ) of the posterior parietal cortex ( PPC ) in patients with acute stroke with visuospatial neglect .\
METHODS	This study was a prospective , double-blind , sham-controlled trial .\
METHODS	Data are presented from 27 patients ( 15 men , 12 women ; mean age , 67.0 y ) randomly assigned to receive 10 sessions of low-frequency ( 1Hz ) rTMS over the nonlesioned PPC , high-frequency ( 10Hz ) rTMS over the lesioned PPC , or sham stimulation .\
METHODS	National university hospital .\
METHODS	Patients ( N = 27 ) diagnosed with visuospatial neglect after stroke .\
METHODS	Ten sessions of rTMS over a 2-week period .\
METHODS	The severity of visuospatial neglect was assessed pre - and posttreatment using the Motor-Free Visual Perception Test , line bisection test , star cancellation test , and Catherine Bergego Scale .\
RESULTS	When comparing the differences in the Motor-Free Visual Perception Test , line bisection test , star cancellation test , Catherine Bergego Scale , and Korean-Modified Barthel Index ( K-MBI ) scores before and after treatment according to group , we found that changes in the line bisection test and K-MBI scores were significantly different between 3 groups .\
RESULTS	In the post hoc analysis , the improvement in the line bisection test score in the high-frequency rTMS group was statistically significant compared with that in the sham stimulation group ( high vs sham P = .03 , low vs sham P = .09 , high vs low P = .58 ) , and the improvements in the K-MBI scores of the 2 rTMS groups were statistically significant compared with those in the sham stimulation group ( high vs sham P < .01 , low vs sham P = .02 , high vs low P = .75 ) .\
CONCLUSIONS	These results indicate that high-frequency rTMS is effective in the treatment of visuospatial neglect in patients with acute stroke .\
\
###19279301\
OBJECTIVE	A low-glycemic index diet is effective as a treatment for individuals with diabetes and has been shown to improve pregnancy outcomes when used from the first trimester .\
OBJECTIVE	A low-glycemic index diet is commonly advised as treatment for women with gestational diabetes mellitus ( GDM ) .\
OBJECTIVE	However , the efficacy of this advice and associated pregnancy outcomes have not been systematically examined .\
OBJECTIVE	The purpose of this study was to determine whether prescribing a low-glycemic index diet for women with GDM could reduce the number of women requiring insulin without compromise of pregnancy outcomes .\
METHODS	All women with GDM seen over a 12-month period were considered for inclusion in the study .\
METHODS	Women ( n = 63 ) were randomly assigned to receive either a low-glycemic index diet or a conventional high-fiber ( and higher glycemic index ) diet .\
RESULTS	Of the 31 women randomly assigned to a low-glycemic index diet , 9 ( 29 % ) required insulin .\
RESULTS	Of the women randomly assigned to a higher-glycemic index diet , a significantly higher proportion , 19 of 32 ( 59 % ) , met the criteria to commence insulin treatment ( P = 0.023 ) .\
RESULTS	However , 9 of these 19 women were able to avoid insulin use by changing to a low-glycemic index diet .\
RESULTS	Key obstetric and fetal outcomes were not significantly different .\
CONCLUSIONS	Using a low-glycemic index diet for women with GDM effectively halved the number needing to use insulin , with no compromise of obstetric or fetal outcomes .\
\
###16246231\
BACKGROUND	The proton pump inhibitor ( PPI ) - based 7-day triple therapy is the regimen with the highest cure rates for eradication of Helicobacter pylori infection and has been recommended as the first-line regimen in the world .\
BACKGROUND	It had been reported that a 1-day quadruple therapy could also successfully cure 95 % of the H. pylori infected patients .\
OBJECTIVE	To observe the efficacy of 1-day high-dose quadruple therapy versus 7-day triple therapy for treatment of H. pylori infection , and to observe side-effects of the two different regimens .\
METHODS	This randomized , open , parallel-controlled study was conducted at Renji Hospital between November 2004 to March 2005 .\
METHODS	A total of 80 consecutive patients with non-ulcer dyspepsia , who were H. pylori positive proven by both rapid urease test and histology were included and randomly assigned to 1-day quadruple therapy or 7-day triple therapy .\
METHODS	Thirty-nine patients were administered with 1-day high-dose quadruple therapy including esomeprazole 40 mg b.i.d. , colloidal bismuth subcitrate 440 mg q.i.d. , amoxicillin 2 g q.i.d. and metronidazole ( 400 mg q.i.d. ) for 1 day .\
METHODS	Forty-one patients received a standard 7-day triple therapy consisting of esomeprazole 20 mg b.i.d. , clarithromycin 500 mg b.i.d. and amoxicillin 1 g b.i.d. for 7 days .\
METHODS	The eradication rates were evaluated by the ( 13 ) C-urea breath test at least 4 weeks after completion of a course treatment .\
RESULTS	Seventy-seven patients completed the trial and three patients dropped out .\
RESULTS	The eradication rates in the 1-day therapeutic group and the 7-day therapeutic group were 39.5 % ( 15/38 ) and 84.6 % ( 33/39 ) , respectively .\
RESULTS	There was a statistically significant difference between the two groups ( P < 0.0001 ) .\
RESULTS	Short-lasting and self-limiting side effects including thirst , a metallic taste , diarrhea and abdominal pain were reported in three patients ( 7.9 % ) in the 1-day group and seven patients ( 18 % ) in the 7-day group ( P = 0.31 ) .\
CONCLUSIONS	A 1-day high-dose quadruple therapy with amoxicillin , metronidazole , bismuth salt , and esomeprazole is not effective for eradication of H. pylori compared with the standard 7-day triple therapy .\
\
###24424141\
OBJECTIVE	To test the hypothesis that patients with soft tissue changes related to superficial venous insufficiency ( SVI ) have greater benefits from treatment than those with only symptomatic varicose veins .\
BACKGROUND	A commonly held view is that SVI is only a minor ailment , yet randomized clinical trials ( RCTs ) show that treatment improves quality of life ( QoL ) and is cost-effective .\
BACKGROUND	In an effort to curb the treatment costs of this common disorder , rationing is applied in many health care systems , often limiting the reimbursement of treatment to those with soft tissue changes .\
METHODS	This cohort study draws its data from an interventional RCT .\
METHODS	After informed consent , consecutive patients with symptomatic unilateral SVI were randomized to receive surgical ligation and stripping or endovenous laser ablation .\
METHODS	This analysis differentially studies the outcomes of patients with simple varicose veins ( C2 : n = 191 ) and soft tissue complications ( C3-4 : n = 76 ) .\
METHODS	Effectiveness outcomes measured up to 1 year included the following : Qol [ short form 36 ( SF36 ) , EuroQol , and the Aberdeen Varicose Veins Questionnaire ] , clinical recurrence , and the need for secondary procedures .\
METHODS	Multivariable regression analysis was used to control for potential confounding factors .\
RESULTS	Both groups saw significant improvements in QoL .\
RESULTS	All improvements were equal between groups apart from the SF36 domain of Bodily Pain , where C2 saw an improvement of 12.8 [ 95 % confidence interval ( CI ) : 4.8-20 .8 ] points over C3-4 participants ( P = 0.002 ) , who also suffered more recurrence [ odds ratio ( OR ) = 2.7 , 95 % CI : 1.2-6 .1 , P = 0.022 ] and required more secondary procedures ( OR = 4.4 , 95 % CI : 1.2-16 .3 , P = 0.028 ) .\
CONCLUSIONS	This study suggests that rationing by clinical severity contradicts the evidence .\
CONCLUSIONS	Delaying treatment until the development of skin damage leads to a degree of irreversible morbidity and greater recurrence .\
BACKGROUND	NCT00759434 Clinicaltrials.gov .\
\
###7798505\
OBJECTIVE	This study assessed the effect of the combination of aspirin and dipyridamole on patency of the infarct-related artery between 4 weeks and 1 year after myocardial infarction .\
BACKGROUND	Patency of the infarct-related artery is an important determinant of prognosis after myocardial infarction .\
BACKGROUND	The incidence of late reocclusion and the effects of antiplatelet therapy are unknown .\
METHODS	To investigate the importance of antiplatelet therapy for the prevention of late reocclusion , 215 patients who had a patent infarct-related artery 4 weeks after myocardial infarction were randomized in a double-blind manner to receive either a combination of 25 mg of aspirin and 200 mg of dipyridamole twice daily or placebo .\
METHODS	One hundred fifty-four patients underwent further coronary arteriography 1 year later .\
RESULTS	At 1 year , 38 ( 25 % ) of 154 patients had reocclusion of the infarct-related artery ; 18 ( 23 % ) of 79 patients receiving aspirin and dipyridamole had late reocclusion versus 20 ( 27 % ) of 75 who received placebo ( p = NS ) .\
RESULTS	The rate of reocclusion was related to the severity of the residual coronary artery stenosis at 4 weeks ( < 50 % stenosis 9.2 % ; 50 % to 69 % stenosis 11.6 % ; 70 % to 89 % stenosis 30.4 % ; > or = 90 % stenosis 70 % , p < 0.01 ) .\
RESULTS	The majority of reocclusions were silent , and only 17 ( 45 % ) of 38 were clinically associated with further infarction .\
RESULTS	There were no differences for a hierarchic end point of cardiac death , myocardial infarction or revascularization ( 14.8 % aspirin and dipyridamole vs. 17.8 % placebo ) .\
CONCLUSIONS	Late reocclusion of the patent infarct-related artery is a frequent event , occurring in 25 % of patients .\
CONCLUSIONS	Antiplatelet therapy with the combination of aspirin and dipyridamole does not alter the overall rate of late reocclusion .\
CONCLUSIONS	Other strategies are required to reduce late reocclusion .\
\
###12390375\
BACKGROUND	Several methods for skin closure are used , i.e. sutures , adhesive papertape and tissue adhesives .\
BACKGROUND	Little is known about the efficacy of these techniques in laparoscopic surgery .\
BACKGROUND	This study was performed to analyse the efficacy of octylcyanoacrylate , a new tissue adhesive , adhesive papertape and poliglecaprone for wound closure in laparoscopy .\
METHODS	From May 2000 to September 2001 , 140 patients were included in a prospective randomized trial .\
METHODS	Wounds were closed with octylcyanoacrylate ( n = 48 ) , adhesive papertape ( n = 42 ) or poliglecaprone ( n = 50 ) .\
METHODS	Closing time , wound infection , cosmetic results and costs were evaluated .\
METHODS	A time-motion analysis was also performed .\
RESULTS	The patients in the three groups were well matched for age , gender and body mass index .\
RESULTS	Closing times per wound were 26 , 33 and 65 s respectively for adhesive papertape , octylcyanoacrylate and poliglecaprone ( P < 0.001 ) .\
RESULTS	Cosmetic results , as scored by the patients , were no different .\
RESULTS	The number of actions required to close each wound was 5.7 , 8.3 and 21.0 for octylcyanoacrylate , adhesive papertape ( P = 0.05 versus octylcyanoacrylate ) and poliglecaprone ( P < 0.01 versus octylcyanoacrylate and adhesive papertape ) respectively .\
RESULTS	Octylcyanoacrylate was significantly more expensive than poliglecaprone and adhesive papertape .\
CONCLUSIONS	Closure with adhesive papertape was the fastest method .\
CONCLUSIONS	The smallest number of actions required to close a wound was with octylcyanoacrylate .\
CONCLUSIONS	Adhesive papertape was the most cost-effective .\
\
###20670323\
OBJECTIVE	Studies have suggested that poor knowledge of the Ottawa Ankle Rules ( OAR ) limits its clinical impact .\
OBJECTIVE	This study evaluated the ability of a mnemonic to improve knowledge of the OAR .\
METHODS	This was a single-blind randomized controlled trial performed among residents and medical students doing a pediatric emergency medicine rotation .\
METHODS	At baseline , all participants were tested for their baseline knowledge of the OAR .\
METHODS	The intervention was a standardized information sheet providing a mnemonic of the OAR ( 44-55-66-PM ) , while control subjects received its classic description .\
METHODS	Block randomization ( medical student vs. type of resident ) was used .\
METHODS	Each participant answered the same questionnaire at the end of rotation ( 3 weeks later ) and via a Web-based survey 5 to 9 months postrandomization .\
METHODS	Main outcome measures were knowledge of the components of the ankle rule based on a 13-item criterion grid and the foot rule based on a 10-item criterion grid .\
METHODS	All questionnaires were marked at the end of the study by two reviewers blinded to the randomization .\
METHODS	Discrepancies in final scores were resolved by consensus .\
METHODS	Student 's t-test was performed to compare mean scores on the evaluation between groups using an intention-to-treat approach .\
RESULTS	Among the 206 eligible participants , 96 medical students and 94 residents were recruited and agreed to participate .\
RESULTS	Primary outcomes were measured in 95 % of the participants at 3 weeks postrandomization and in 72 % on the long-term follow-up .\
RESULTS	Participants in both groups were similar with regard to baseline characteristics and prior knowledge of the OAR .\
RESULTS	Both groups showed improvement in their knowledge of the rule during the study period .\
RESULTS	At mid-term , knowledge of the OAR was similar for the ankle components ( score for mnemonic 10.9 ; control 10.2 ; 95 % confidence interval [ CI ] for difference = -0.3 to 1.7 ) and for the foot ( mnemonic 7.6 vs. control 7.5 ; 95 % CI for difference = -0.7 to 0.9 ) .\
RESULTS	On the long term , randomization to the mnemonic was associated with a better knowledge of the OAR as demonstrated by a higher score for the ankle component ( mnemonic 10.1 vs. control 8.9 ; 95 % CI for difference = 0.6 to 1.8 ) and for the foot ( mnemonic 7.8 vs. control 6.5 ; 95 % CI for difference = 0.8 to 1.9 ) .\
CONCLUSIONS	Mid-term knowledge of the OAR drastically improved for all participants of the study .\
CONCLUSIONS	The use of the mnemonic 44-55-66-PM was associated with a better long-term knowledge of the OAR among medical students and residents .\
CONCLUSIONS	The improvement in knowledge of the OAR among the control group highlights the importance of using controlled trials for studies evaluating knowledge transfer .\
\
###18517077\
BACKGROUND	Diphenhydramine is often the treatment of choice for acute urticarial or allergic reactions despite its adverse effects of sedation and impairment .\
BACKGROUND	Second - and third-generation histamine1-antihistamines are generally devoid of these adverse effects but are typically not used because of a perceived slower onset of action .\
OBJECTIVE	To examine the time-dependent effects of oral fexofenadine and oral and intramuscular diphenhydramine to reduce histamine-induced wheal-and-flare responses .\
METHODS	Eighteen healthy patients were included in a double-blind , placebo-controlled , 3-way , randomized , crossover study with oral fexofenadine ( 180 mg ) and oral and intramuscular diphenhydramine ( 50 mg ) .\
METHODS	Histamine-induced skin tests were performed before and more than 6 hours subsequent to dosing .\
METHODS	The primary end point was time to induce a 50 % reduction in histamine-induced flare .\
METHODS	Secondary end points included change from baseline at each time point in wheal-and-flare responses and area under the curve at more than 6 hours for flare .\
RESULTS	No significant differences were found in the 50 % inhibitory responses of histamine-induced flares among the 3 groups ( P = .09 ) .\
RESULTS	No significant differences were found among the 3 groups in change from baseline at each time point except for 30 minutes during which fexofenadine had no inhibitory effect .\
RESULTS	Area under the curve analyses for wheal-and-flare responses revealed no differences among treatments at more than 6 hours .\
CONCLUSIONS	Diphenhydramine tended to work more rapidly than fexofenadine , but the differences were not statistically significant .\
CONCLUSIONS	Given the adverse effect profile of diphenhydramine , but only marginal onset of action advantage , the risk-to-benefit ratio may be more favorable for oral fexofenadine when treating an acute urticarial or allergic reaction .\
\
###7949497\
OBJECTIVE	Current growth hormone ( GH ) therapy with daily subcutaneous injections results in elevated serum concentrations of GH lasting for several hours , whereas physiologic GH secretion is characterized by a short-duration peak and low basal concentrations .\
OBJECTIVE	A closer imitation of this pattern might be achieved by administering GH nasally .\
OBJECTIVE	We studied the effect on the absorption of nasally administered human GH of increasing concentrations of the enhancer didecanoyl-L-alpha-phosphatidylcholine ( DDPC ) .\
METHODS	Four formulations of nasal GH containing the enhancer DDPC in the relative concentrations 0 , 4 , 8 , and 16 % w/w were administered in random order .\
METHODS	Participants were admitted to the hospital during the four study periods .\
METHODS	On four occasions the subjects received GH 6 IU ( 2 mg ) in each nostril .\
METHODS	Blood was sampled frequently for four hours .\
METHODS	Anterior rhinoscopy was performed at 0 and 4 h.\
METHODS	During the study the subjects completed a questionnaire to record nasal symptoms .\
METHODS	Sixteen healthy subjects were examined at 0800 h after an overnight fast .\
METHODS	Bioavailability of a nasal preparation of human GH : area under the curve ( AUC ) , the maximum concentration ( Cmax ) , and the time to reach maximum concentration ( tmax ) .\
METHODS	Scores for each nasal symptom were recorded as were the total scores .\
RESULTS	AUC , Cmax , and tmax were not significantly affected by increasing the DDPC concentration from 0 to 4 percent or from 8 to 16 percent .\
RESULTS	AUC and Cmax , however , increased significantly when the concentration of DDPC was changed from 4 to 8 percent .\
RESULTS	Mean ( + / - SD ) AUC ( microgram.h / L ) increased from 20.51 + / - 10.53 ( 4 percent ) to 46.14 + / - 34.59 ( 8 percent ) , ( p < 0.005 ) .\
RESULTS	Mean ( + / - SD ) of Cmax ( microgram/L ) increased from 11.11 + / - 5.02 ( 4 percent ) to 28.22 + / - 20.85 ( 8 percent ) , ( p = 0.002 ) .\
RESULTS	Mean ( + / - SD ) of tmax ( min ) was not significantly different on the four occasions ( range 40.6 + / - 36.4 to 61.0 + / - 45.2 min , p = 0.13 ) .\
RESULTS	The symptom scores ( range 17.56-21 .5 , maximum 360 ) were not significantly different ( p = 0.59 ) .\
CONCLUSIONS	Increasing the relative concentration of the enhancer DDPC increases the absorption of nasally administered GH .\
\
###19432566\
OBJECTIVE	To determine if vitamin C and E supplementation in high-risk pregnant women with low nutritional status reduces pre-eclampsia .\
METHODS	Multicentred , randomised , controlled , double-blinded trial .\
METHODS	Antenatal care clinics and Hospitals in four countries .\
METHODS	Pregnant women between 14 and 22 weeks ' gestation .\
METHODS	Randomised women received 1000 mg vitamin C and 400 iu of vitamin E or placebo daily until delivery .\
METHODS	Pre-eclampsia , low birthweight , small for gestational age and perinatal death .\
RESULTS	Six hundred and eighty-seven women were randomised to the vitamin group and 678 to the placebo group .\
RESULTS	Groups had similar gestational ages ( 18.1 ; SD 2.4 weeks ) , socio-economic , clinical and demographical characteristics and blood pressure at trial entry .\
RESULTS	Risk factors for eligibility were similar , except for multiple pregnancies : placebo group ( 14.7 % ) , vitamins group ( 11.8 % ) .\
RESULTS	Previous pre-eclampsia , or its complications , was the most common risk factor at entry ( vitamins 41.6 % , placebo 41.3 % ) .\
RESULTS	Treatment compliance was 87 % in the two groups and loss to follow-up was low ( vitamins 2.0 % , placebo 1.3 % ) .\
RESULTS	Supplementation was not associated with a reduction of pre-eclampsia ( RR : 1.0 ; 95 % CI : 0.9-1 .3 ) , eclampsia ( RR : 1.5 ; 95 % CI : 0.3-8 .9 ) , gestational hypertension ( RR : 1.2 ; 95 % CI : 0.9-1 .7 ) , nor any other maternal outcome .\
RESULTS	Low birthweight ( RR : 0.9 ; 95 % CI : 0.8-1 .1 ) , small for gestational age ( RR : 0.9 ; 95 % CI : 0.8-1 .1 ) and perinatal deaths ( RR : 0.8 ; 95 % CI : 0.6-1 .2 ) were also unaffected .\
CONCLUSIONS	Vitamins C and E at the doses used did not prevent pre-eclampsia in these high-risk women .\
\
###15213207\
BACKGROUND	The Women 's Health Initiative Memory Study ( WHIMS ) previously reported that estrogen plus progestin therapy does not protect cognition among women aged 65 years or older .\
BACKGROUND	The effect of estrogen-alone therapy , also evaluated in WHIMS , on cognition has not been established for this population .\
OBJECTIVE	To determine whether conjugated equine estrogen ( CEE ) alters global cognitive function in older women and to compare its effect with CEE plus medroxyprogesterone acetate ( CEE plus MPA ) .\
METHODS	A randomized , double-blind , placebo-controlled ancillary study of the Women 's Health Initiative ( WHI ) , WHIMS evaluated the effect of CEE on incidence of probable dementia among community-dwelling women aged 65 to 79 years with prior hysterectomy from 39 US academic centers that started in June 1995 .\
METHODS	Of 3200 eligible women free of probable dementia enrolled in the WHI , 2947 ( 92.1 % ) were enrolled in WHIMS .\
METHODS	Analyses were conducted on the 2808 women ( 95.3 % ) with a baseline and at least 1 follow-up measure of global cognitive function before the trial 's termination on February 29 , 2004 .\
METHODS	Participants received 1 daily tablet containing either 0.625 mg of CEE ( n = 1387 ) or matching placebo ( n = 1421 ) .\
METHODS	Global cognitive function measured annually with the Modified Mini-Mental State Examination ( 3MSE ) .\
RESULTS	During a mean follow-up of 5.4 years , mean ( SE ) 3MSE scores were 0.26 ( 0.13 ) units lower than among women assigned to CEE compared with placebo ( P = .04 ) .\
RESULTS	For pooled hormone therapy ( CEE combined with CEE plus MPA ) , the mean ( SE ) decrease was 0.21 ( 0.08 ; P = .006 ) .\
RESULTS	Removing women with dementia , mild cognitive impairment , or stroke from the analyses lessened these differences .\
RESULTS	The adverse effect of hormone therapy was more pronounced among women with lower cognitive function at baseline ( all P < .01 ) .\
RESULTS	For women assigned to CEE compared with placebo , the relative risk of having a 10-unit decrease in 3MSE scores ( > 2 SDs ) was estimated to be 1.47 ( 95 % confidence interval , 1.04-2 .07 ) .\
CONCLUSIONS	For women aged 65 years or older , hormone therapy had an adverse effect on cognition , which was greater among women with lower cognitive function at initiation of treatment .\
\
###22622008\
BACKGROUND	It is unknown whether combined chemoradiotherapy improves overall survival in elderly patients with locally advanced non-small-cell lung cancer ( NSCLC ) .\
BACKGROUND	The aim of this study was to assess whether radiotherapy plus carboplatin results in longer survival than radiotherapy alone in elderly patients with NSCLC .\
METHODS	This was a randomised , controlled , phase 3 trial by the Japan Clinical Oncology Group ( JCOG0301 ) .\
METHODS	Patients older than 70 years with unresectable stage III NSCLC were randomly assigned to chemoradiotherapy ( 60 Gy plus concurrent low-dose carboplatin [ 30 mg/m ( 2 ) per day , 5 days a week for 20 days ] ) or radiotherapy alone , using a minimisation method with biased-coin assignment balancing on Eastern Cooperative Oncology Group ( ECOG ) performance status ( 0 vs 1 vs 2 ) , stage ( IIIA vs IIIB ) , and institution .\
METHODS	The primary endpoint was overall survival , which was analysed for the eligible population and stratified by ECOG performance status , stage , and institution .\
METHODS	The trial was stopped early as a result of the second planned interim analysis .\
METHODS	This study is registered with UMIN Clinical Trials Registry , number C000000060 , and ClinicalTrials.gov , number NCT00132665 .\
RESULTS	200 patients were enrolled from Sept 1 , 2003 to May 27 , 2010 : 100 in the chemoradiotherapy group and 100 in the radiotherapy group .\
RESULTS	The second planned interim analysis was done 10 months after completion of patient accrual .\
RESULTS	At this time , median follow-up for censored cases was 194 months ( IQR 103-335 ) .\
RESULTS	In accordance with the prespecified stopping rule , the JCOG data and safety monitoring committee recommended early publication of this trial because the difference in overall survival favoured the chemoradiotherapy group .\
RESULTS	Median overall survival for the chemoradiotherapy and radiotherapy alone groups were 224 months ( 95 % CI 165-336 ) and 169 months ( 134-203 ) , respectively ( hazard ratio 068 , 954 % CI 047-098 , stratified log-rank test one-sided p value = 00179 ) .\
RESULTS	More patients had grade 3-4 haematological toxic effects in the chemoradiotherapy group than in the radiotherapy alone group , including leucopenia ( 61 [ 635 % ] vs none ) , neutropenia ( 55 [ 573 % ] vs none ) , and thrombocytopenia ( 28 [ 292 % ] vs two [ 20 % ] ) .\
RESULTS	Grade 3 infection was more common with chemoradiotherapy ( 12 patients [ 125 % ] ) than with radiotherapy ( four patients [ 41 % ] ) .\
RESULTS	Incidences of grade 3-4 pneumonitis and late lung toxicity were similar between groups .\
RESULTS	There were seven treatment-related deaths : three of 100 patients ( 30 % ) in the chemoradiotherapy group and four of 100 ( 40 % ) in the radiotherapy group .\
CONCLUSIONS	For a select group of elderly patients with locally advanced NSCLC , combination chemoradiotherapy provides a clinically significant benefit over radiotherapy alone , and should be considered for this population .\
BACKGROUND	Ministry of Health , Labour , and Welfare of Japan .\
\
###20617907\
BACKGROUND	Thermocouples and electrothermometers are used in therapeutic modality research .\
BACKGROUND	Until recently , researchers assumed that these instruments were valid and reliable .\
OBJECTIVE	To examine 3 different thermocouple types in 5 degrees C , 15 degrees C , 18.4 degrees C , 25 degrees C , and 35 degrees C water baths .\
METHODS	Randomized controlled trial .\
METHODS	Therapeutic modality laboratory .\
METHODS	Eighteen thermocouple leads were inserted through the wall of a foamed polystyrene cooler .\
METHODS	The cooler was filled with water .\
METHODS	Six thermocouples ( 2 of each model ) were plugged into the 6 channels of the Datalogger and 6 randomly selected channels in the 2 Iso-Thermexes .\
METHODS	A mercury thermometer was immersed into the water and was read every 10 seconds for 4 minutes during each of 6 trials .\
METHODS	The entire process was repeated for each of 5 water bath temperatures ( 5 degrees C , 15 degrees C , 18.4 degrees C , 25 degrees C , 35 degrees C ) .\
METHODS	Temperature and absolute temperature differences among 3 thermocouple types ( IT-21 , IT-18 , PT-6 ) and 3 electrothermometers ( Datalogger , Iso-Thermex calibrated from -50 degrees C to 50 degrees C , Iso-Thermex calibrated from -20 degrees C to 80 degrees C ) .\
RESULTS	Validity and reliability were dependent on thermocouple type , electrothermometer , and water bath temperature ( P < .001 ; modified Levene P < .05 ) .\
RESULTS	Statistically , the IT-18 and PT-6 thermocouples were not reliable in each electrothermometer ; however , these differences were not practically different from each other .\
RESULTS	The PT-6 thermocouples were more valid than the IT-18s , and both thermocouple types were more valid than the IT-21s , regardless of water bath temperature ( P < .001 ) .\
CONCLUSIONS	The validity and reliability of thermocouples interfaced to an electrothermometer under experimental conditions should be tested before data collection .\
CONCLUSIONS	We also recommend that investigators report the validity , the reliability , and the calculated uncertainty ( validity + reliability ) of their temperature measurements for therapeutic modalities research .\
CONCLUSIONS	With this information , investigators and clinicians will be better able to interpret and compare results and conclusions .\
\
###22124042\
BACKGROUND	The present study was aimed at comparing the clinical effectiveness of two regenerative techniques - platelet rich plasma ( PRP ) + bone graft ( HA + TCP ) versus bone graft ( HA + TCP ) + normal saline in the treatment of periodontal intrabony defects .\
METHODS	Ten patients diagnosed with chronic periodontitis were enrolled in a randomized split mouth clinical trial .\
METHODS	Following phase I therapy the sites were randomly assigned to the test group - PRP + bone graft ( HA + TCP ) and control group - saline + bone graft ( HA + TCP ) .\
METHODS	Clinical parameters recorded at baseline and 6 months included plaque index , probing pocket depth , relative attachment levels , and relative gingival margin levels .\
METHODS	Hard tissue evaluation was done using digital radiography to evaluate the image intensity and therefore the radioopacity of a desired region of interest in the intrabony defect .\
METHODS	Pre - and postoperative comparisons were made between the treatment groups at 6 months .\
RESULTS	Test group sites showed a significantly higher reduction in pocket depth compared to control group sites .\
RESULTS	Test group sites showed a significantly higher amount of radioopacity in the regions of interest , indicative of better graft remodeling , compared to control group sites .\
CONCLUSIONS	( HA + TCP ) bone graft appears to be a beneficial material in the treatment of human periodontal intrabony defects .\
CONCLUSIONS	When combined with platelet-rich plasma there is a significantly higher reduction in probing pocket depth , higher gain in attachment levels and higher amount of radio-density seen in the intrabony defects .\
\
###20089937\
OBJECTIVE	To evaluate the efficacy and safety of adjunctive topiramate ( sprinkle capsules or oral liquid ) in reducing daily rates of partial-onset seizures ( POS ) in infants with refractory POS .\
METHODS	In this double-blind , placebo-controlled , parallel-group , international study , infants ( n = 149 ) with clinical or EEG evidence of refractory POS were randomly allocated ( 1:1:1:1 ) to receive adjunctive topiramate 5 , 15 , or 25 mg/kg/d or placebo for 20 days .\
METHODS	The primary variable was the median percentage reductions in daily POS rate from baseline to final assessment as recorded on a 48-hour video-EEG .\
RESULTS	Of the 149 infants ( mean age 12 months ) included in the intent-to-treat analysis set , 130 completed the study .\
RESULTS	Median percentage reduction from baseline in daily POS rate was not significantly different ( p = 0.97 ) between topiramate 25 mg/kg ( 20.4 % ) and placebo ( 13.1 % ) .\
RESULTS	Lower doses were not formally tested , but nominal p values for comparisons with placebo were not significant ( 15-mg/kg/d dose : p = 0.97 ; 5-mg/kg/d dose : p = 0.91 ) .\
RESULTS	Treatment-emergent fever , diarrhea , vomiting , anorexia , weight decrease , somnolence , and viral infection occurred more frequently ( > or = 10 % difference ) with topiramate than with placebo .\
CONCLUSIONS	In infants aged 1-24 months , topiramate 5 , 15 , or 25 mg/kg/d was not effective as adjunctive treatment for refractory partial-onset seizures .\
CONCLUSIONS	No new safety concerns associated with topiramate use were noted .\
METHODS	This interventional study provides Class I evidence that topiramate 5 , 15 , or 25 mg/kg/d compared with placebo does not significantly reduce seizure rates in infants aged 1 month to 2 years with refractory partial-onset seizures .\
\
###25516016\
BACKGROUND	Although uncomplicated cystitis is often self-limiting , most such patients will be prescribed antibiotic treatment .\
BACKGROUND	We are investigating whether treatment of cystitis with an NSAID is as effective as an antibiotic in achieving symptomatic resolution .\
METHODS	This is a randomized , controlled , double blind trial following the principles of Good Clinical Practice .\
METHODS	Women between the ages of 18 to 60 presenting with symptoms of uncomplicated cystitis are screened for eligibility .\
METHODS	500 women from four sites in Norway , Sweden and Denmark are allocated to treatment with 600 mg ibuprofen three times a day or 200 mg mecillinam three times a day for three days .\
METHODS	Allocation is conducted using block randomization .\
METHODS	The primary outcome is the number of patients who feel cured by day four as recorded in a diary .\
METHODS	Adverse events will be handled and reported in accordance with Good Clinical Practice .\
CONCLUSIONS	If treatment of uncomplicated cystitis with ibuprofen is as effective as mecillinam for symptom relief , we can potentially reduce the use of antibiotics on a global scale .\
BACKGROUND	EudraCTnr : 2012-002776-14 .\
BACKGROUND	ClinicalTrials.gov : NCT01849926 .\
\
###12798874\
OBJECTIVE	To evaluate the implantation rate achieved after chemical removal of the zona pellucida from day 5 human in vitro-derived embryos .\
METHODS	Prospective , randomized , controlled study .\
METHODS	A tertiary care infertility clinic .\
METHODS	Two hundred fifty-seven patients undergoing IVF with transfer of morulas or blastocysts on day 5 after oocyte retrieval .\
METHODS	All patients had had at least two previous implantation failures .\
METHODS	Chemical removal of zona pellucida by using acidic Tyrode 's solution vs. no removal ( controls ) .\
METHODS	Clinical pregnancy rate and implantation rate per transfer .\
RESULTS	Embryos without zona pellucida implanted at nearly twice the rate of control embryos ( 15.7 % vs. 27.5 % ) .\
RESULTS	The pregnancy rate was also significantly higher in the zona pellucida-free group than the control group ( 31.0 % vs. 46.1 % ) .\
RESULTS	Removal of zona pellucida was most effective in embryos with delayed development , which reached the morula or early cavitating stage on day 5 of in vitro culture ( implantation rate , 12.1 % vs. 25.7 % ) .\
CONCLUSIONS	Chemical removal of zona pellucida from day 5 in vitro cultured human embryos is an effective and safe method of significantly improving the implantation rate , especially of embryos with delayed development .\
\
###9818335\
OBJECTIVE	To quantify and compare the phaco time required using in situ nucleofracture and phaco chop techniques .\
METHODS	Center for Research on Ocular Therapeutics and Biodevices and Miyake Laboratory , Storm Eye Institute , Medical University of South Carolina , Charleston , South Carolina , USA .\
METHODS	Thirty human eyes obtained postmortem were randomly divided into 2 groups of 15 eyes each .\
METHODS	In situ nucleofracture or phaco chop was performed in each group .\
METHODS	The phaco time required for each technique was determined .\
RESULTS	The mean phaco time was 0.91 minutes + / - 0.37 ( SD ) for the phaco chop and 1.56 + / - 0.89 minutes for the in situ fracture technique ( P < .015 ) .\
CONCLUSIONS	The phaco chop technique reduced phaco time and total phaco power consumed during phacoemulsification without imposing a risk of intraoperative complications .\
\
###25923549\
BACKGROUND	The EGFR T790M mutation is the most common mechanism of drug resistance to epidermal growth factor receptor ( EGFR ) tyrosine kinase inhibitors in patients who have lung cancer with an EGFR mutation ( EGFR-mutated lung cancer ) .\
BACKGROUND	In preclinical models , the EGFR inhibitor AZD9291 has been shown to be effective against both EGFR tyrosine kinase inhibitor-sensitizing and T790M resistance mutations .\
METHODS	We administered AZD9291 at doses of 20 to 240 mg once daily in patients with advanced lung cancer who had radiologically documented disease progression after previous treatment with EGFR tyrosine kinase inhibitors .\
METHODS	The study included dose-escalation cohorts and dose-expansion cohorts .\
METHODS	In the expansion cohorts , prestudy tumor biopsies were required for central determination of EGFR T790M status .\
METHODS	Patients were assessed for safety , pharmacokinetics , and efficacy .\
RESULTS	A total of 253 patients were treated .\
RESULTS	Among 31 patients enrolled in the dose-escalation cohorts , no dose-limiting toxic effects occurred at the doses evaluated .\
RESULTS	An additional 222 patients were treated in five expansion cohorts .\
RESULTS	The most common all-cause adverse events were diarrhea , rash , nausea , and decreased appetite .\
RESULTS	The overall objective tumor response rate was 51 % ( 95 % confidence interval [ CI ] , 45 to 58 ) .\
RESULTS	Among 127 patients with centrally confirmed EGFR T790M who could be evaluated for response , the response rate was 61 % ( 95 % CI , 52 to 70 ) .\
RESULTS	In contrast , among 61 patients without centrally detectable EGFR T790M who could be evaluated for response , the response rate was 21 % ( 95 % CI , 12 to 34 ) .\
RESULTS	The median progression-free survival was 9.6 months ( 95 % CI , 8.3 to not reached ) in EGFR T790M-positive patients and 2.8 months ( 95 % CI , 2.1 to 4.3 ) in EGFR T790M-negative patients .\
CONCLUSIONS	AZD9291 was highly active in patients with lung cancer with the EGFR T790M mutation who had had disease progression during prior therapy with EGFR tyrosine kinase inhibitors .\
CONCLUSIONS	( Funded by AstraZeneca ; ClinicalTrials.gov number , NCT01802632 . )\
\
###10683002\
BACKGROUND	Ductal carcinoma in situ ( DCIS ) of the breast is a disorder that has become more common since it may manifest as microcalcifications that can be detected by screening mammography .\
BACKGROUND	Since selected women with invasive cancer can be treated safely with breast conservation therapy it is paradoxical that total mastectomy has remained the standard treatment for DCIS .\
BACKGROUND	We did a randomised phase III clinical trial to investigate the role of radiotherapy after complete local excision of DCIS .\
METHODS	Between 1986 and 1996 , women with clinically or mammographically detected DCIS measuring less than or equal to 5 cm were treated by complete local excision of the lesion and then randomly assigned to either no further treatment ( n = 503 ) or to radiotherapy ( n = 507 ; 50 Gy in 5 weeks to the whole breast ) .\
METHODS	The median duration of follow-up was 4.25 years ( maximum 12.0 years ) .\
METHODS	All analyses were by intention to treat .\
RESULTS	500 patients were followed up in the no further treatment group and 502 in the radiotherapy group .\
RESULTS	In the no further treatment group 83 women had local recurrence ( 44 recurrences of DCIS , and 40 invasive breast cancer ) .\
RESULTS	In the radiotherapy group 53 women had local recurrences ( 29 recurrences of DCIS , and 24 invasive breast cancer ) .\
RESULTS	The 4-year local relapse-free was 84 % in the group treated with local excision alone compared with 91 % in the women treated by local excision plus radiotherapy ( log rank p = 0.005 ; hazard ratio 0.62 ) .\
RESULTS	Similar reductions in the risk of invasive ( 40 % , p = 0.04 ) and non-invasive ( 35 % , p = 0.06 ) local recurrence were seen .\
CONCLUSIONS	Radiotherapy after local excision for DCIS , as compared with local excision alone , reduced the overall number of both invasive and non-invasive recurrences in the ipsilateral breast at a median follow-up of 4.25 years .\
\
###16469992\
BACKGROUND	Increasing intakes of long-chain n-3 polyunsaturated fatty acids ( PUFAs ) can decrease markers of immunity .\
BACKGROUND	However , dose - and age-related responses have not been identified .\
OBJECTIVE	The objective was to determine the effects of different amounts of eicosapentaenoic acid ( EPA ) on innate immune outcomes in young and older males .\
METHODS	In a controlled , double-blind study , healthy young and older men consumed 1 of 4 supplements provided as capsules : placebo ( corn oil ) or different amounts of an oil providing 1.35 , 2.7 , or 4.05 g EPA/d for 12 wk .\
METHODS	Blood samples were collected at baseline and after 12 wk .\
RESULTS	EPA was incorporated in a linear dose-response fashion into plasma and mononuclear cell ( MNC ) phospholipids ; incorporation was greater in the older men .\
RESULTS	EPA treatment did not alter neutrophil or monocyte phagocytosis , monocyte respiratory burst , or the production of inflammatory cytokines by MNCs in the young or older men .\
RESULTS	EPA treatment caused a dose-dependent decrease in neutrophil respiratory burst only in the older men .\
RESULTS	Increased incorporation of EPA into plasma or MNC phospholipids was associated with decreased production of prostaglandin E2 by MNCs from both young and older men .\
CONCLUSIONS	Older subjects incorporate EPA into plasma and MNC phospholipids more readily than do younger subjects .\
CONCLUSIONS	Other than prostaglandin E2 production , innate immune responses in young subjects are not affected by an EPA intake of < or = 4.05 g/d .\
CONCLUSIONS	Older subjects are more sensitive to the immunologic effects of EPA , and the neutrophil respiratory burst is lower at higher EPA intakes .\
\
###10758988\
OBJECTIVE	This report describes whether lossy Joint Photographic Experts Group ( UPEG ) image compression/decompression has an effect on the quantitative assessment of vessel sizes by state-of-the-art quantitative coronary arteriography ( QCA ) .\
BACKGROUND	The Digital Imaging and Communications in Medicine ( DICOM ) digital exchange standard for angiocardiography prescribes that images must be stored loss free , thereby limiting JPEG compression to a maximum ratio of 2:1 .\
BACKGROUND	For practical purposes it would be desirable to increase the compression ratio ( CR ) , which would lead to lossy image compression .\
METHODS	A series of 48 obstructed coronary segments were compressed/decompressed at CR 1:1 ( uncompressed ) , 6:1 , 10:1 and 16:1 and analyzed blindly and in random order using the QCA-CMS analytical software .\
METHODS	Similar catheter and vessel start - and end-points were used within each image quartet , respectively .\
METHODS	All measurements were repeated after several weeks using newly selected start - and end-points .\
METHODS	Three different sub-analyses were carried out : the intra-observer , fixed inter-compression and variable inter-compression analyses , with increasing potential error sources , respectively .\
RESULTS	The intra-observer analysis showed significant systematic and random errors in the calibration factor at JPEG CR 10:1 .\
RESULTS	The fixed inter-compression analysis demonstrated systematic errors in the calibration factor and recalculated vessel parameter results at CR 16:1 and for the random errors at CR 10:1 and 16:1 .\
RESULTS	The variable inter-compression analysis presented systematic and random errors in the calibration factor and recalculated parameter results at CR 10:1 and 16:1 .\
RESULTS	Any negative effect at CR 6:1 was found only for the calibration factor of the variable inter-compression analysis , which did not show up in the final vessel measurements .\
CONCLUSIONS	Compression ratios of 10:1 and 16:1 affected the QCA results negatively and therefore should not be used in clinical research studies .\
\
###12030959\
BACKGROUND	In the management of Helicobacter pylori induced duodenal ulcer , it is still controversial whether anti-secretory treatment needs to be continued following a 1-week course of eradication therapy .\
METHODS	150 patients with H. pylori active duodenal ulcer ( diameter > or = 5 mm ) were included .\
METHODS	After a 1-week eradication treatment combining omeprazole 20 mg b.d. , amoxicillin 1000 mg b.d. and clarithromycin 500 mg b.d. ( OAC ) , patients were randomized to omeprazole 20 mg or placebo for 3 additional weeks .\
METHODS	The primary variable was ulcer healing assessed at 4 weeks .\
METHODS	Eradication was verified 4 weeks after cessation of study drugs by 13C-urea breath test .\
METHODS	Intention-to-treat analysis ( ITT ) included 131 patients with positive histopathology at inclusion .\
RESULTS	Healing rates were not statistically different , at 89 % and 87 % , respectively , in the OAC-omeprazole and OAC-placebo groups ( 95 % CI : -8.7 ; 13.7 ) .\
RESULTS	Numerically , healing rates in patients with successful eradication was higher [ 94/104 ( 90 % ) ] than in patients with failed eradication [ 21/27 ( 78 % ) ] .\
RESULTS	However , the difference was not statistically significant ( P < 0.1 ) .\
CONCLUSIONS	One-week OAC eradication triple therapy achieves excellent healing rates in patients with uncomplicated duodenal ulcer disease .\
CONCLUSIONS	Although the confidence interval of the difference in healing suggests little or no benefit of continued omeprazole treatment after 1 week , larger studies are needed to address this issue definitively .\
\
###10496259\
OBJECTIVE	To assess the efficacy of lamotrigine , a novel antiepileptic drug that inhibits glutamate release , to retard disease progression in Huntington disease ( HD ) .\
BACKGROUND	Excitatory amino acids may cause selective neuronal death in HD , and lamotrigine may inhibit glutamate release in vivo .\
METHODS	A double-blinded , placebo-controlled study was conducted of 64 patients with motor signs of less than 5 years ' duration who were randomly assigned to either placebo or lamotrigine and assessed at 0 ( baseline ) , 12 , 24 , and 30 months .\
METHODS	The primary response variable was total functional capacity ( TFC ) score .\
METHODS	Secondary response variables included the quantified neurological examination and a set of cognitive and motor tests .\
METHODS	Repeated fluorodeoxyglucose measurements of regional cerebral metabolism using PET also were included .\
RESULTS	Fifty-five patients ( 28 on lamotrigine , 27 on placebo ) completed the study .\
RESULTS	Neither the primary response variable nor any of the secondary response variables differed significantly between the treatment groups .\
RESULTS	Both the lamotrigine and the placebo group deteriorated significantly on the TFC , in the lamotrigine group by 1.89 and the placebo group by 2.11 points .\
RESULTS	No effect of CAG size on the rate of deterioration could be detected .\
CONCLUSIONS	There was no clear evidence that lamotrigine retarded the progression of early Huntington disease over a period of 30 months .\
CONCLUSIONS	However , more patients on lamotrigine reported symptomatic improvement ( 53.6 versus 14.8 % ; p = 0.006 ) , and a trend toward decreased chorea was evident in the treated group ( p = 0.08 ) .\
CONCLUSIONS	The study also identified various indices of disease progression , including motor tests and PET studies , that were sensitive to deterioration over time .\
\
###16164766\
BACKGROUND	Magnetic resonance imaging ( MRI ) studies have especially reported smaller hippocampal volume in patients with post-traumatic stress disorder ( PTSD ) , most of them war or sexual abuse victims .\
BACKGROUND	The present study compares the hippocampal volumes of out-patients with PTSD who had low co-morbidity rates to those of trauma-exposed control subjects without PTSD , and measures hippocampal volume changes in these patients after brief eclectic psychotherapy .\
BACKGROUND	We hypothesized that smaller hippocampal volumes are specific to PTSD and that hippocampal volume changes after effective psychotherapy would be measurable .\
METHODS	Eighteen patients with PTSD and 14 traumatized control subjects were examined with MRI .\
METHODS	In a randomized clinical trial , the PTSD patients were assigned to treatment ( n = 9 ) or waiting-list group ( n = 9 ) .\
METHODS	After the former received psychotherapy for 4 months , the MRI was repeated on both PTSD groups .\
METHODS	Three temporal lobe structures were manually segmented : hippocampus , amygdala , and parahippocampal gyrus .\
METHODS	Volumetric analysis was used to measure grey matter , white matter , and cerebrospinal fluid .\
RESULTS	PTSD patients had significantly smaller hippocampal volumes at baseline ( total 13.8 % , right 13.5 % , left 14.1 % ) compared to the control subjects .\
RESULTS	After effective psychotherapy , however , no volume changes were found in the smaller hippocampi .\
CONCLUSIONS	We confirmed previous findings of smaller hippocampal volume in PTSD in a new population made up of out-patients who experienced different types of traumas , reducing co-morbidity to a minimum .\
CONCLUSIONS	Smaller hippocampal volumes did not change after effective psychotherapy , even while symptoms resolved .\
\
###17152332\
OBJECTIVE	To determine the feasibility and efficacy ofa nurse-led clinic for stable patients recovering from a recent myocardial infarction , as opposed to a resident-led clinic .\
METHODS	Randomized study .\
METHODS	Over a period of 1 year , data on the treatment and complications of 200 consecutive infarction patients were collected .\
METHODS	The patients were randomized on transfer from the coronary-care unit to the cardiology ward .\
METHODS	Subsequently , these patients were treated by a registered nurse practitioner ( n = 97 ) or by a resident ( n = 103 ) , both of whom were under the direct supervision of the attending cardiologist .\
METHODS	Degree of satisfaction was scored by the patients on a 0-10 point scale .\
RESULTS	The patients in both groups were predominantly men ( 75 % ) with a mean age of 63 years .\
RESULTS	Risk factors and cardiac histories were comparable in both groups as were the location of the infarction and the nature of the acute treatment .\
RESULTS	No significant differences between the groups were found in the main endpoints : mortality ( 0 % ) , re-infarctions ( 2 % ) or length ofstay .\
RESULTS	However , patients treated by the nurse practitioner expressed a significantly higher score in the satisfaction study .\
CONCLUSIONS	The treatment of stable postmyocardial infarction patients in a nurse-practitioner-led clinic post was found to be feasible and effective with a significantly higher level of patient satisfaction .\
\
###12409965\
OBJECTIVE	To investigate the hypothesis that weight reduction with orlistat plus mild caloric restriction leads to better blood pressure control than diet alone in obese individuals with inadequately controlled hypertension .\
OBJECTIVE	DESIGN This was a 1-year , prospective , randomized , double-blind , placebo-controlled , multicenter trial of orlistat plus diet versus placebo plus diet in obese hypertensives .\
METHODS	Participants were randomized to receive either orlistat or placebo ; all received a 600 kcal deficient diet with no more than 30 % of calories from fat .\
METHODS	Weight and blood pressure , lipid levels and fasting glucose and insulin levels were followed .\
METHODS	Patients on orlistat experienced greater weight loss ( -5.4 + / - 6.4 versus -2.7 + / - 6.4 kg , P < 0.001 ) and greater reduction in body mass index ( -1.9 + / - 2.3 versus -0.9 + / - 2.2 kg/m2 , P < 0.001 ) .\
METHODS	Target weight loss , defined as > or = 5 % body weight ( BW ) , was obtained in more orlistat-treated patients than in the placebo group ( 46 versus 23 % , P < 0.001 ) .\
METHODS	Diastolic BP decreased more in orlistat-treated patients than in the placebo group ( -11.4 + / - 8.3 versus -9.2 + / - 8.4 mmHg , P = 0.002 ) .\
METHODS	A greater percentage of orlistat-treated patients reached goal diastolic blood pressure ( BP ) , defined as final diastolic BP < 90 mmHg or a reduction of at least 10 mmHg ( 67 versus 53 % , P < 0.001 ) .\
METHODS	The orlistat-treated group had significantly greater reductions in total cholesterol ( P < 0.001 ) , low-density lipoprotein cholesterol ( P = 0.001 ) and non-high-density lipoprotein cholesterol ( P < 0.005 ) and target 30 % cardiovascular risk reduction was obtained in more orlistat-treated patients ( 36.1 versus 24.0 % , P < 0.04 ) .\
CONCLUSIONS	A weight-loss program with orlistat is more effective than diet alone to lower blood pressure and results in greater cardiovascular risk reduction .\
\
###15737670\
BACKGROUND	In humans and animals , corticosteroid excess is associated with impairment in declarative memory and changes in hippocampal structure .\
BACKGROUND	In animals , phenytoin pretreatment blocks the effects of stress on memory and hippocampal histology , although no studies have examined the use of phenytoin to prevent corticosteroid-associated memory changes in humans .\
BACKGROUND	Mood changes are also common with corticosteroids , but few treatment data are available .\
BACKGROUND	This report examines whether phenytoin can prevent mood or declarative memory changes secondary to bursts of prescription corticosteroids .\
METHODS	Thirty-nine patients with allergies or pulmonary or rheumatologic illnesses and given systemic corticosteroid therapy were randomized to receive either phenytoin ( 300 mg/day ) or placebo concurrently with the corticosteroids .\
METHODS	Mood was assessed with the Hamilton Rating Scale for Depression , Young Mania Rating Scale , and Activation ( ACT ) subscale of the Internal State Scale ; declarative memory was assessed with the Rey Auditory Verbal Learning Test ( RAVLT ) at baseline and after approximately 7 days of corticosteroid plus phenytoin or placebo therapy .\
RESULTS	The two groups were similar in age , gender , education , and corticosteroid dose .\
RESULTS	The phenytoin-treated group showed significantly smaller increases on the ACT , a mania self-report scale , than the placebo-treated group .\
RESULTS	Groups did not differ significantly on RAVLT change scores .\
CONCLUSIONS	This is the first placebo-controlled study to examine whether a medication can prevent mood and memory changes secondary to corticosteroids .\
CONCLUSIONS	Phenytoin blocked the hypomanic effects of prescription corticosteroids ; however , phenytoin did not block the declarative memory effects of corticosteroids .\
\
###24830400\
OBJECTIVE	The effectiveness of the prophylactic clip for the prevention of postpolypectomy bleeding in pedunculated colonic polyps has not been confirmed .\
OBJECTIVE	The aim of this prospective , randomized study was to compare the efficacy of prophylactic clip and endoloop application in the prevention of postpolypectomy bleeding in large pedunculated polyps .\
METHODS	A total of 195 patients who had pedunculated colorectal polyps , with heads 10mm and stalks 5mm in diameter , were included in the study between July 2010 and January 2013 .\
METHODS	Polyps were randomized to receive either clips or endoloops .\
METHODS	Both devices were applied to the base of the stalk before conventional snare polypectomy .\
METHODS	Bleeding complications were analyzed with a noninferiority margin of 5 % .\
RESULTS	A total of 203 polyps were included in the study ( 98 in the clip group and 105 in the endoloop group ) .\
RESULTS	Bleeding occurred after five polypectomies in the clip group ( 5.1 % ) and after six in the endoloop group ( 5.7 % ) ( P = 0.847 ) .\
RESULTS	Noninferiority of the prophylactic clip to the endoloop could not be confirmed ( absolute bleeding rate difference-0 .6 % , 95 % confidence interval -5.6 % to 6.8 % ) due to small sample size .\
RESULTS	Immediate bleeding episodes occurred in 4/5 polyps in the clip group and 5/6 polyps in the endoloop group .\
RESULTS	Delayed bleeding occurred in one polyp in each group .\
CONCLUSIONS	These results suggest that the application of a prophylactic clip is as effective and safe as an endoloop in the prevention of postpolypectomy bleeding in large pedunculated colonic polyps .\
BACKGROUND	ClinicalTrials.gov ( NCT01406379 ) .\
\
###18541793\
BACKGROUND	Little is known about short-term vascular risk after transient ischemic attack ( TIA ) caused by intracranial atherosclerosis .\
OBJECTIVE	To quantify the early risk of ischemic stroke in the territory of a stenotic intracranial artery after TIA and to identify clinical and imaging features associated with increased risk of stroke in the territory among patients with TIA .\
METHODS	Cohort study .\
METHODS	Academic research .\
METHODS	Patients The Warfarin-Aspirin Symptomatic Intracranial Disease ( WASID ) study enrolled patients having TIA or nondisabling stroke within the preceding 3 months and demonstrating corresponding 50 % to 99 % stenosis of a major intracranial artery on angiography .\
METHODS	We calculated the cumulative risk of stroke in the territory of the symptomatic artery during the first 90 days after randomization among patients having TIA alone as a qualifying event compared with patients having stroke alone .\
METHODS	We assessed selected factors for association with stroke among patients having TIA as the qualifying event .\
RESULTS	The 90-day risk of ischemic stroke in the arterial territory was 6.9 % ( 95 % confidence interval , 4.2 % -11.2 % ) after TIA compared with 4.7 % ( 95 % confidence interval , 2.7 % -8.4 % ) after stroke ( P = .32 ) .\
RESULTS	Among patients having TIA alone as the qualifying event , 60.0 % ( 15 of 25 ) of all strokes in the arterial territory occurred in the first 90 days compared with 34.4 % ( 11 of 32 ) among patients having stroke alone as the qualifying event ( P = .05 ) .\
RESULTS	Among subjects with TIA , the presence of cerebral infarct on baseline neuroimaging was the only statistically significant predictor of higher risk of early stroke ( hazard ratio , 4.7 ; 95 % confidence interval , 1.4-15 .5 ; P = .006 ) .\
CONCLUSIONS	Among individuals having intracranial atherosclerotic disease with TIA , most subsequent strokes in the territory of a stenotic intracranial artery occur early ( ie , < or = 90 days ) .\
CONCLUSIONS	Prompt management of TIA in patients having intracranial stenosis , particularly those demonstrating cerebral infarction on brain imaging , is indicated .\
\
###2504377\
OBJECTIVE	To compare grip strength and bone mineral content in the forearm in women and to test the effects on bone mineral content of short periods of exercise that stresses the skeleton .\
METHODS	Assessment of both wrists in 69 volunteers and of the non-fractured wrist in 30 patients followed by an exercise regimen entailing squeezing a tennis ball as hard as possible for 30 seconds each day for six weeks .\
METHODS	Old people 's homes and outpatient departments of Hammersmith and Northampton general hospitals .\
METHODS	99 Women , of whom 69 were volunteers and 30 had a fractured forearm .\
METHODS	Grip strength and bone mineral content after six weeks and at six months after the exercises had stopped .\
RESULTS	The bone mineral content of the women 's forearms was measured with a densitometer and the grip strength with a semi-inflated bag connected to an anaeroid barometer .\
RESULTS	Measurements before exercise showed that the two variables correlated closely , irrespective of age , and that there were significant differences in both between the dominant and non-dominant arms of the volunteers .\
RESULTS	After six weeks of exercise there was a mean increase in grip strength of 14.5 % ( 95 % confidence interval 9.9 to 19.2 % ) and in bone mineral content of 3.4 % ( 1.4 to 5.3 % ) in the stressed forearms of the 77 women who attended for examination .\
RESULTS	After six months without exercise the improvements in the 33 women who attended for follow up had reversed .\
RESULTS	Women who had had a fractured forearm ( n = 13 ) , however , had continued to gain grip strength and bone mineral content in the arm that had not been injured .\
CONCLUSIONS	Grip strength in the forearm is a good indicator of bone mineral content .\
CONCLUSIONS	Both variables may be increased by brief periods of stressful exercise .\
CONCLUSIONS	If this principle can be applied to the whole skeleton it may provide a means of reversing osteoporosis .\
\
###11521985\
BACKGROUND	Studies in animals indicate that endogenous nitric oxide ( NO ) is an important inhibitory neurotransmitter in the gastrointestinal tract and that it modulates food intake .\
BACKGROUND	We evaluate the role of NO mechanisms in mediating the effects of small intestinal nutrients on antropyloroduodenal motility and appetite in humans .\
METHODS	On 2 separate days , 8 healthy adult men received intravenous L-NAME 180 microg/kg/h or 0.9 % saline ( 0-150 min ) ; between 30 min and 120 min , an intraduodenal lipid infusion ( 2 kcal/min ) was administered , and at 120 min subjects were offered a buffet meal ( 120-150 min ) .\
METHODS	Antropyloroduodenal pressures were measured with a sleeve/sidehole manometric assembly .\
METHODS	During the infusions , perceptions of hunger and fullness were assessed with visual analog questionnaires and amount and macronutrient content of food consumed at the buffet meal were quantified .\
METHODS	Blood pressure and heart rate were monitored at regular intervals .\
RESULTS	Intraduodenal lipid infusion was associated with increases in fullness ( P < 0.05 ) and in frequency of isolated pyloric pressure waves ( P < 0.05 ) and basal pyloric pressure ( P < 0.05 ) ; and decreases in hunger ( P < 0.05 ) and in frequency of antral ( P < 0.05 ) and duodenal ( P < 0.05 ) pressure waves .\
RESULTS	L-NAME increased diastolic blood pressure ( P = 0.08 ) and decreased heart rate ( P < 0.05 ) , but had no effect on antropyloroduodenal pressures or food intake .\
CONCLUSIONS	Intravenous administration of the systemic NO synthase inhibitor , L-NAME , in a dose that affects cardiovascular function in healthy humans does not modify the antropyloroduodenal motor and appetite responses to intraduodenal lipid infusion .\
\
###21212064\
BACKGROUND	Decision support to facilitate informed consent is increasingly important for complicated medical tests .\
BACKGROUND	Here , we test a theoretical model of factors influencing decisional conflict in a study examining the effects of a decision support aid that was designed to assist patients at high risk for hereditary nonpolyposis colorectal cancer ( CRC ) deciding whether to pursue the microsatellite instability ( MSI ) test .\
METHODS	Participants were 239 CRC patients at high familial risk for a genetic mutation who completed surveys before and after exposure to the intervention .\
METHODS	Half of the sample was assigned to the CD-ROM aid and half received a brief description of the test .\
METHODS	Structural equation modeling was employed to examine associations among the intervention , knowledge , pros and cons to having MSI testing , self-efficacy , preparedness , and decisional conflict .\
RESULTS	The goodness of fit for the model was acceptable [ FIML , full information maximum likelihood , ( 2 ) ( df = 280 ) = 392.24 ; P = 0.00 ] .\
RESULTS	As expected , the paths to decisional conflict were significant for postintervention pros of MSI testing ( t = -2.43 ; P < 0.05 ) , cons of MSI testing ( t = 2.78 ; P < 0.05 ) , and preparedness ( t = -7.27 ; P < 0.01 ) .\
RESULTS	The intervention impacted decisional conflict by increasing knowledge about the MSI test and knowledge exerted its effects on decisional conflict by increasing preparedness to make a decision about the test and by increases in perceived benefits of having the test .\
CONCLUSIONS	Increasing knowledge , preparedness , and perceived benefits of undergoing the MSI test facilitate informed decision making for this test .\
CONCLUSIONS	Understanding mechanisms underlying health decisions is critical for improving decisional support .\
CONCLUSIONS	Individuals with Lynch syndrome have an elevated lifetime risk of CRC .\
CONCLUSIONS	Risk of Lynch syndrome may be assessed with a tumor-based screening test ( MSI testing or immunohistochemical tissue staining ) .\
\
###12634020\
BACKGROUND	This study tested the effects of two organizational support processes , the provision of financial incentives for superior clinical performance and the availability of a patient ( smoker ) registry and proactive telephone support system for smoking cessation , on provider adherence to accepted practice guidelines and associated patient outcomes .\
METHODS	Forty clinics of a large multispecialty medical group practice providing primary care services were randomly allocated to study conditions .\
METHODS	Fifteen clinics each were assigned to the experimental conditions `` control '' ( distribution of printed versions of smoking cessation guidelines ) and `` incentive '' ( financial incentive pay-out for reaching preset clinical performance targets ) .\
METHODS	Ten clinics were randomized to receive financial incentives combined with access to a centralized patient registry and intervention system ( `` registry '' ) .\
METHODS	Main outcome measures were adherence to smoking cessation clinical practice guidelines and patients ' smoking cessation behaviors .\
RESULTS	Patients ' tobacco use status was statistically significant ( P < 0.01 ) more frequently identified in clinics with the opportunity for incentives and access to a registry than in clinics in the control condition .\
RESULTS	Patients visiting registry clinics accessed counseling programs statistically significantly more often ( P < 0.001 ) than patients receiving care in the control condition .\
RESULTS	Other endpoints did not statistically significantly differ between the experimental conditions .\
CONCLUSIONS	The impact of financial incentives and a patient registry/intervention system in improving smoking cessation clinical practices and patient behaviors was mixed .\
CONCLUSIONS	Additional research is needed to identify conditions under which such organizational support processes result in significant health care quality improvement and warrant the investment .\
\
###23193905\
OBJECTIVE	We compared anesthesia with sevoflurane-remifentanil hydrochloride ( SR ) to total intravenous anesthesia with propofol-remifentanil hydrochloride ( PR ) in patients undergoing endoscopic sinus surgery for chronic rhinosinusitis in terms of sinonasal mucosal blood flow , the surgical field visualization score , and blood loss .\
METHODS	We performed a double-blinded prospective study at a tertiary care center in 23 adults scheduled to undergo endoscopic sinus surgery for chronic rhinosinusitis .\
METHODS	The patients were randomized to receive SR or PR .\
METHODS	The sinonasal mucosal blood flow was measured by optical rhinometry .\
METHODS	The surgical field visualization score was based on the Boezaart scale .\
RESULTS	The groups had similar clinical characteristics .\
RESULTS	During the 60 - to 90-minute and 90 - to 120-minute operative time windows , the blood flow was significantly greater in the PR group than in the SR group ( p = 0.04 and p = 0.03 , respectively ) .\
RESULTS	The amounts of blood loss in the PR and SR groups were 152.9 + / - 161.3 mL and 355.9 + / - 393.4 mL , respectively ( p = 0.12 ) .\
RESULTS	The median ratios of the surgical field visualization score to the number of sinuses operated on in the PR and SR groups were 2.1 and 1.8 , respectively ( p = 0.52 ) .\
CONCLUSIONS	The intraoperative blood flow , as determined by optical rhinometry , was significantly greater with anesthesia with PR than with anesthesia with SR , 1 hour into the procedure ; however , this difference did not translate into differences in the amounts of operative blood loss or in the surgical field visualization scores .\
\
###19841330\
OBJECTIVE	Approximately 30 % to 40 % patients with a superficial bladder cancer treated with Bacille Calmette-Guerin ( BCG ) or epirubicin do not respond ; of the initial responders , 35 % have a relapse within 5 years .\
OBJECTIVE	We compare the therapeutic efficacy and toxicity of intravescical infusions of gemcitabine ( GEM ) with mitomycin ( MMC ) in patients with a recurrent superficial bladder cancer .\
METHODS	Patients with a history of a previously treated , recurrent Ta-T1 , G1-G3 bladder transitional cell carcinoma were enrolled in the study .\
METHODS	The patients received a 6-week course of GEM infusions or 4-week course of MMC .\
METHODS	In both arms , for the initial responders who remained free of recurrences , maintenance therapy consisted of 10 monthly treatments during the first year .\
RESULTS	A total of 120 patients were enrolled and randomly assigned to either the MMC or GEM treatment arm .\
RESULTS	At the end of the study , 109 patients ( 55 in MMC and 54 in GEM ) were assessable .\
RESULTS	The median duration of follow-up was 36 months for either arm .\
RESULTS	In the GEM arm , 39 ( 72 % ) of 54 patients remained free of recurrence versus 33 ( 61 % ) of 55 in MMC arm .\
RESULTS	Among patients with recurrences , 10 in the MMC arm and six in the GEM arm also had a progressive disease by stage .\
RESULTS	The incidence of chemical cystitis in the MMC arm was statistically higher than in the GEM arm ( P = .012 ) .\
CONCLUSIONS	This study demonstrates that GEM has better efficacy and lower toxicity than MMC ; therefore , GEM appears as a logical candidate for intrabladder therapy in patients with refractory transitional cancer .\
\
###25080458\
BACKGROUND	Clinical weight loss in individuals typically stabilizes at 6 mo. .\
BACKGROUND	However , validated models of dynamic energy balance have consistently shown weight plateaus between 1 and 2 y.\
BACKGROUND	The cause for this discrepancy is unclear .\
OBJECTIVE	We developed 2 mathematical models on the basis of the first law of thermodynamics to investigate plausible explanations for reaching an early weight plateau at 6 mo. .\
METHODS	The first model was an energy-expenditure adaptation model and was applied to determine the degree of metabolic adaptation required to generate this plateau .\
METHODS	The second model was an intermittent lack-of-adherence model formulated by using a randomly fluctuating energy intake term accounting for intermittent noncompliance in dietary intake to reach this plateau .\
METHODS	To set model variables , validate models , and compare free-living weight-loss patterns to in-residence supervised programs , we applied the following 4 different studies : The US NHANES 1999-2004 , Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy ( CALERIE ) weight-loss study , the Bouchard Twin overfeeding study , and the Minnesota Starvation Experiment .\
RESULTS	The metabolic adaptation model increased final weight but did not affect the predicted plateau time point .\
RESULTS	The intermittent lack-of-adherence model generated oscillating weight graphs that have been frequently observed in weight-loss studies .\
RESULTS	The model showed that a 6-mo weight-loss plateau can be attained despite what can be considered as high diet adherence .\
RESULTS	The model was programmed as a downloadable application .\
CONCLUSIONS	An intermittent lack of diet adherence , not metabolic adaptation , is a major contributor to the frequently observed early weight-loss plateau .\
CONCLUSIONS	The new weight-loss prediction software , which incorporates an intermittent lack of adherence , can be used to guide and inform patients on realistic levels of adherence on the basis of patient lifestyle .\
\
###23260261\
OBJECTIVE	Central retinal vein occlusion ( CRVO ) or branch retinal vein occlusion ( BRVO ) causes hypoperfusion , high levels of vascular endothelial growth factor ( VEGF ) , macular edema , and loss of vision .\
OBJECTIVE	Many patients also show areas of complete closure of retinal vessels ( retinal nonperfusion [ RNP ] ) that increase over time .\
OBJECTIVE	The objective was to assess the effect of blocking VEGF on progression of RNP .\
METHODS	Retrospective analysis of prospectively collected data from 2 randomized , sham injection-controlled , double-masked , multicenter clinical trials .\
METHODS	A total of 392 and 397 patients with macular edema due to CRVO or BRVO .\
METHODS	An independent reading center measured the area of RNP on fluorescein angiograms ( FAs ) in 2 phase III trials investigating the effect of ranibizumab ( RBZ ; Lucentis ; Genentech , Inc , South San Francisco , CA ) in patients with CRVO or BRVO .\
METHODS	The percentage of patients with no posterior RNP at months 0 , 3 , 6 , 9 , and 12 .\
RESULTS	There was no difference among treatment groups at baseline , but at the month 6 primary end point the percentage of patients with CRVO and no RNP was significantly greater in the RBZ groups ( 0.3 mg , 82.0 % , P = 0.0092 ; 0.5 mg , 84.0 % , P = 0.0067 ) versus the sham group ( 67.0 % ) .\
RESULTS	Reperfusion of nonperfused retina was rare ( 1 % ) in sham-treated patients with CRVO , but occurred in 6 % to 8 % of patients with CRVO treated with RBZ ( 30 % of those who had RNP and could improve ) .\
RESULTS	Results in patients with BRVO mirrored those in patients with CRVO .\
RESULTS	Crossover to 0.5 mg RBZ from sham at month 6 halted the progression of RNP and resulted in improvement in both CRVO and BRVO .\
CONCLUSIONS	Treatment with RBZ did not worsen RNP in patients with RVO , but rather reduced its occurrence compared with sham .\
CONCLUSIONS	These data provide an important new insight regarding the pathogenesis of RVO ; the initial vein occlusion is a precipitating event that causes baseline ischemia and release of VEGF , which then contributes to progression of RNP and thus worsening of ischemia .\
CONCLUSIONS	Timely , aggressive blockade of VEGF prevents the worsening of RNP , promotes reperfusion , and eliminates a positive feedback loop .\
\
###15974216\
OBJECTIVE	The objective of this research was to evaluate the dental plaque control effect of a chewing gum versus brushing with a dentifrice via four clinical studies .\
METHODS	Study 1 compared a commercial chewing gum ( Colgate Dental Gum , CDG ) with a water control after 24 hours post-brushing ; Studies 2 and 3 compared CDG to two different brands of commercially available fluoride dentifrices after 24 hours post-brushing ; Study 4 examined the anti-plaque effect of CDG plus a regular fluoride dentifrice ( Colgate Winterfresh Gel , CWG ) versus brushing with CWG alone for five days .\
METHODS	The 24-hour clinical tests employed the Modified Gingival Margin Plaque Index ( MGMPI ) , while the Quigley-Hein Plaque Index ( QHPI ) was used for the five-day study .\
METHODS	All studies utilized a randomized , crossover design with a one-week washout period , and were single-blinded to the clinical evaluator .\
RESULTS	In Study 1 , the mean MGMPI score for CDG was significantly lower ( p < 0.05 ) compared to the water control .\
RESULTS	In Studies 2 and 3 , while brushing with regular fluoride dentifrices provided improved plaque control compared to CDG , the chewing gum alone with no tooth brushing delivered a plaque reduction 60 % as effective as brushing with a fluoride dentifrice .\
RESULTS	In Study 4 , the group using the combination of chewing with CDG and brushing with CWG provided a significantly lower ( p < 0.05 ) mean QHPI score compared to the group using the dentifrice only , particularly on the hard-to-brush lingual surfaces .\
CONCLUSIONS	Four clinical studies demonstrated that CDG provides a plaque control benefit .\
CONCLUSIONS	The results suggest that chewing gum may serve as an effective oral hygiene device when brushing may not be possible and , additionally , that chewing gum may serve as an effective adjunct to brushing for enhanced oral health .\
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###20524104\
OBJECTIVE	To determine the effect of topically applied lidocaine on perioperative airway complications when using a laryngeal mask airway device ( LMAD ) in children either with or without a history of recent or ongoing upper respiratory tract infection ( URI ) .\
METHODS	In a randomized controlled double-blind trial , 34 children with a history of recent or ongoing URI and 32 non-URI children - all of whom were younger than age ten and scheduled to undergo minor surgical procedures-were randomly assigned to either a lidocaine or a placebo group .\
METHODS	In the lidocaine group , an LMAD was lubricated with lidocaine gel before insertion , and a clear lubricating gel was used in the placebo group .\
METHODS	The following data were recorded after standardized anesthesia induction and airway management : postoperative complications , such as coughing , desaturation , laryngospasm , and increased oral secretions , as well as length of stay in the postanesthetic recovery unit .\
RESULTS	Children with URI had a lower overall perioperative complication rate if they received a lidocaine gel ( 35 % ) rather than placebo ( 94 % ) ( P < 0.01 ) .\
RESULTS	Also , the incidence of postoperative coughing was less ( 12 % vs 53 % ; P = 0.03 ) .\
RESULTS	In non-URI patients , lidocaine did not significantly reduce the rate of airway complications compared with placebo ( 17 % vs 24 % , respectively ) .\
CONCLUSIONS	Lubrication of the LMAD with lidocaine gel reduces the incidence of airway complications in children with an upper respiratory tract infection .\
\
###8615705\
BACKGROUND	The 1988 US National Cholesterol Education Program Expert Panel Report recommended initial treatment with niacin or bile acid sequestrants , followed by other agents if needed , to lower low-density lipoprotein cholesterol ( LDL-C ) levels in hypercholesterolemic patients who require drug therapy .\
BACKGROUND	It is unknown how the effectiveness and costs of such an approach ( `` stepped care '' ) compare in typical clinical practice to those of initial therapy with lovastatin .\
METHODS	We randomly assigned 612 patients , aged 20 to 70 years , who met 1988 National Cholesterol Education Program guidelines for drug treatment of elevated LDL-C level and had not previously used cholesterol-lowering medication , to either a stepped-care regimen or initial therapy with lovastatin ( both n = 306 ) .\
METHODS	The study , conducted at Southern California Kaiser Permanente , was designed to approximate typical practice : provider compliance with treatment plans was encouraged but not enforced , and patients paid for medication as they customarily would .\
RESULTS	At 1 year , the decline in mean LDL-C level was significantly greater among patients assigned to initial treatment with lovastatin ( 22 % vs 15 % for stepped care ; P < .001 ) , as was the number who attained goal LDL-C level ( < / = 4.14 mmol/L [ < / = 160 mg/dL ] , or < / = 3.36 mmol/L [ < / = 130 mg/dL ] if coronary heart disease or two or more risk factors were present ) ( 40 % vs 24 % ; P < .001 ) .\
RESULTS	The increase in mean high-density lipoprotein cholesterol levels was significantly greater in the stepped-care group , however ( 8 % vs 1 % for lovastatin ; P < .001 ) .\
RESULTS	Patients who were randomized to stepped care were more likely to report substantial bother caused by side effects ( 30 % vs 16 % for lovastatin ; P < .001 ) and discontinuation of therapy at 1 year ( 28 % vs 18 % , respectively ; P < .01 ) .\
RESULTS	Costs of care were $ 333 higher per patient in the lovastatin group ( $ 786 vs $ 453 ; P < .001 ) .\
CONCLUSIONS	A stepped-care regimen beginning with niacin is less costly than initial therapy with lovastatin , but also less effective in lowering LDL-C level .\
CONCLUSIONS	While it is more effective in increasing high-density lipoprotein cholesterol levels , the tolerability of such a regimen may be a problem .\
\
###8116712\
OBJECTIVE	Meta-analysis of randomized trials of Doppler ultrasonography in high-risk pregnancies has showed reduced mortality rates among normally formed fetuses .\
OBJECTIVE	This trial addressed the impact on outcome of umbilical artery velocimetry in a nonselected population ( i.e. , as a screening test in low-risk and high-risk pregnancies ) .\
METHODS	A randomized , controlled trial with Doppler ultrasonographic investigation was performed at two gestational age windows : 26 to 30 weeks and 34 to 36 weeks .\
METHODS	The 2986 women were randomly allocated to revealed or concealed groups in which the Doppler results were either made available or not made available to clinicians ; 1056 women were studied at only the first window , 544 at only the second , and 1386 at both .\
RESULTS	There were no significant differences between groups in antenatal admissions to hospital , preterm deliveries , rates of cesarean section , admission to the neonatal unit , and need for assisted ventilation .\
RESULTS	There was , however , a trend toward fewer stillbirths in the `` revealed '' group ( three vs eight , odds ratio 0.34 , confidence interval 0.10 to 1.07 ) .\
CONCLUSIONS	The incidence of stillbirths was reduced by more than half in the Doppler-revealed group , but the confidence intervals were wide and these findings could be compatible with chance .\
\
###7832339\
BACKGROUND	Unintended hypothermia occurs frequently during surgery and may have adverse effects on the cardiovascular system .\
BACKGROUND	Although the mechanisms responsible for the cardiovascular manifestations of hypothermia are unclear , it is possible that they are sympathetically mediated .\
BACKGROUND	In this prospective study , relationships between body temperature , the neuroendocrine response , and hemodynamic changes in the perioperative period were examined .\
METHODS	Seventy-four elderly patients , undergoing abdominal , thoracic , or lower extremity vascular surgical procedures , were randomly assigned to either `` routine care '' ( n = 37 ) or `` forced-air warming '' ( n = 37 ) groups .\
METHODS	Throughout the intraoperative and early postoperative periods , the routine care group received standard thermal care , and the forced-air warming group received forced-air skin-surface warming .\
METHODS	Core temperature , forearm minus fingertip skin-surface temperature gradient , and plasma concentrations of epinephrine , norepinephrine , and cortisol were measured throughout the perioperative period , and the two groups were compared .\
METHODS	In addition , heart rate and arterial blood pressure were compared between groups .\
RESULTS	The routine care and forced-air warming groups did not differ with regard to age , sex , type of surgical procedures , anesthetic techniques , or postoperative analgesia .\
RESULTS	Mean core temperature was lower in the routine care group on admission to the postanesthetic care unit ( routine care , 35.3 + / - 0.1 degree C ; forced-air warming , 36.7 + / - 0.1 degree C ; P = 0.0001 ) and remained lower during the early postoperative period .\
RESULTS	Forearm minus fingertip skin-surface temperature gradient ( an index of peripheral vasoconstriction ) was greater in the routine care group in the early postoperative period .\
RESULTS	The mean norepinephrine concentration ( pcg/ml ) was greater in the routine care group immediately after surgery ( 480 + / - 70 vs. 330 + / - 30 , P = 0.02 ) and at 60 min ( 530 + / - 50 vs. 340 + / - 30 , P = 0.002 ) and 180 min ( 500 + / - 80 vs. 320 + / - 30 , P = 0.004 ) postoperatively .\
RESULTS	Mean epinephrine concentrations were not significantly different between groups .\
RESULTS	Mean cortisol concentrations were increased in both groups during the early postoperative period ( P < 0.01 ) , but the differences between groups were not significant .\
RESULTS	Systolic , mean , and diastolic arterial blood pressures were significantly higher in the routine care group .\
CONCLUSIONS	Compared with patients in the forced-air warming group , patients receiving routine thermal care had lower core temperatures , a greater degree of peripheral vasoconstriction , higher norepinephrine concentrations , and higher arterial blood pressures in the early postoperative period .\
CONCLUSIONS	These findings suggest a possible mechanism for hypothermia-related cardiovascular morbidity in the perioperative period .\
\
###18689382\
BACKGROUND	There are no large randomized trials of the effect of folic acid dosing regimens on blood folate and homocysteine concentrations .\
OBJECTIVE	We aimed to evaluate the changes in folate and homocysteine concentrations in response to different folic acid doses and to withdrawal in young women not exposed to other sources of folic acid .\
METHODS	Women ( n = 1108 ) were randomly assigned to 1 of 6 intervention groups for which daily intakes of folic acid for 6 mo were 100 microg 1 time/d , 25 microg 4 times/d , 400 microg 1 time/d , 100 microg 4 times/d , 4000 microg 1 time/d , or 4000 microg 1 time/wk .\
METHODS	Plasma and red blood cell folate and homocysteine concentrations were measured at baseline ; at 1 , 3 , and 6 mo ; and 3 mo after the discontinuation of folic acid .\
RESULTS	Folate and homocysteine concentrations were not different at baseline between the groups who had the same daily intake of folic acid as a single dose or multiple doses ( P = 0.058 ) .\
RESULTS	Plasma folate concentrations plateaued at 3 mo with 108 % ( 95 % CI : 97.7 % , 120 % ) , 259 % ( 95 % CI : 240 % , 279 % ) , 460 % ( 95 % CI : 417 % , 503 % ) , and 142 % ( 95 % CI : 123 % , 162 % ) observed increases for the folic acid groups receiving 100 , 400 , and 4000 microg/d and 4000 microg/wk , respectively .\
RESULTS	The rate of reduction in folate concentrations during the 3 mo after cessation of folic acid was dose-dependent-higher intakes were associated with faster reductions .\
CONCLUSIONS	Changes in folate and homocysteine concentrations were unaffected by different dosing schedules .\
CONCLUSIONS	After folic acid cessation , blood folate declined rapidly , which indicated that the intervention-enhanced folate status was rapidly diminished .\
\
###25174321\
OBJECTIVE	The use of evidence-based guidelines can improve the care for asthma patients .\
OBJECTIVE	We implemented a computerized asthma management system in a pediatric emergency department ( ED ) to integrate national guidelines .\
OBJECTIVE	Our objective was to determine whether patient eligibility identification by a probabilistic disease detection system ( Bayesian network ) combined with an asthma management system embedded in the workflow decreases time to disposition decision .\
METHODS	We performed a prospective , randomized controlled trial in an urban , tertiary care pediatric ED .\
METHODS	All patients 2-18 years of age presenting to the ED between October 2010 and February 2011 were screened for inclusion by the disease detection system .\
METHODS	Patients identified to have an asthma exacerbation were randomized to intervention or control .\
METHODS	For intervention patients , asthma management was computer-driven and workflow-integrated including computer-based asthma scoring in triage , and time-driven display of asthma-related reminders for re-scoring on the electronic patient status board combined with guideline-compliant order sets .\
METHODS	Control patients received standard asthma management .\
METHODS	The primary outcome measure was the time from triage to disposition decision .\
RESULTS	The Bayesian network identified 1339 patients with asthma exacerbations , of which 788 had an asthma diagnosis determined by an ED physician-established reference standard ( positive predictive value 69.9 % ) .\
RESULTS	The median time to disposition decision did not differ among the intervention ( 228 min ; IQR = ( 141 , 326 ) ) and control group ( 223 min ; IQR = ( 129 , 316 ) ) ; ( p = 0.362 ) .\
RESULTS	The hospital admission rate was unchanged between intervention ( 25 % ) and control groups ( 26 % ) ; ( p = 0.867 ) .\
RESULTS	ED length of stay did not differ among intervention ( 262 min ; IQR = ( 165 , 410 ) ) and control group ( 247 min ; IQR = ( 163 , 379 ) ) ; ( p = 0.818 ) .\
CONCLUSIONS	The control and intervention groups were similar in regards to time to disposition ; the computerized management system did not add additional wait time .\
CONCLUSIONS	The time to disposition decision did not change ; however the management system integrated several different information systems to support clinicians ' communication .\
\
###25403881\
OBJECTIVE	To compare the effectiveness of the endolymphatic duct blockage ( EDB ) and the endolymphatic sac decompression ( ESD ) to control Mnire 's disease symptoms and to evaluate their effect on hearing level .\
METHODS	Prospective nonblinded randomized study .\
METHODS	Tertiary medical center .\
METHODS	Fifty-seven patients affected by a refractory Mnire 's disease were included out of which 22 underwent an ESD and 35 underwent an EDB .\
METHODS	Five periods of follow-up were considered : 0 to 1 week , 1 week to 6 months , 6 to 12 months , 12 to 18 months , and 18 to 24 months .\
METHODS	Mean outcome measurements consisted of vertigo control , tinnitus , aural fullness , instability , and hearing level .\
METHODS	Hearing level was evaluated using pure-tone average ( PTA ) and speech discrimination score ( SDS ) .\
RESULTS	There was no significant difference between the 2 groups in the number of vertigo spells per months preoperatively ( P = .153 ) .\
RESULTS	Twenty-four months postoperatively , 96.5 % of the EDB group had achieved a complete control of vertigo spells against 37.5 % of the ESD group with a statistically significant difference ( P = .002 ) .\
RESULTS	There was a better control of tinnitus and aural fullness with EDB ( P = .021 and P = .014 , respectively ) .\
RESULTS	There was no statistically significant difference in hearing level preoperatively ( P = .976 ) and 24 months postoperatively ( P = .287 ) between the 2 groups .\
RESULTS	Hearing level was preserved in each group with no significant difference between the preoperative and the postoperative levels ( P > .05 ) .\
CONCLUSIONS	EDB is more effective than the traditional ESD in controlling the symptoms of Mnire 's disease .\
CONCLUSIONS	It is a novel surgical technique with promising results for a complete treatment of Mnire 's disease .\
CONCLUSIONS	There are no significant complications or adverse effect .\
\
###10971777\
OBJECTIVE	This study examined the long-term effects of nitrous oxide anaesthesia on serum levels of cobalamin and folate , red cell folate levels and haematological parameters , and neurological status in elderly Omani patients .\
METHODS	Sixty-nine consecutive patients undergoing ophthalmic surgery were randomly and double-blind assigned to nitrous oxide or propofol anaesthesia .\
METHODS	They met the following entry criteria : age 55 years or above , no major organ failure , no clinical signs or symptoms of cobalamin or folate deficiency , mean cell volume ( MCV ) < / = 96 fl , haematocrit ( Hct ) higher than 0.3 and no cobalamin and/or folate substitution therapy during the preceding months .\
METHODS	Serum levels of cobalamin and folate , red cell folate levels , and haematological parameters were measured prior to anaesthesia and 3-5 weeks later .\
METHODS	At that time , the patients also underwent thorough neurological examination .\
RESULTS	Data of 51 patients were complete and considered for analysis .\
RESULTS	In both nitrous oxide and propofol group , the range of exposure time was comparable ( + / -1 h ) .\
RESULTS	In the nitrous oxide group , a slight but significant decrease in haemoglobin , Hct , and red blood cell count ( RBC ) ( P < 0.001 ) was observed , whereas there was a mild increase in mean cell haemoglobin ( MCH ) and mean cell volume ( P < 0.05 ) .\
RESULTS	In addition , there was a significant decrease in serum folate levels ( P < 0.05 ) .\
RESULTS	Hct and RBC decreased slightly in the propofol group ( P < 0.05 ) , whereas there was a small increase in MCH .\
RESULTS	There was no difference between the two anaesthetics with regard to serum cobalamin and red cell folate levels , but there was a significant decrease in serum folate levels in the nitrous oxide group compared to those in the propofol group .\
RESULTS	Three patients with pre-existing low red cell folate levels , who were randomized to nitrous oxide anaesthesia , developed clinical symptoms of folate deficiency .\
CONCLUSIONS	This study showed that short-term ( 40-80 min ) nitrous oxide anaesthesia did not affect cobalamin levels but reduced serum folate levels in this elderly population .\
CONCLUSIONS	Although this reduction was clinically irrelevant , some patients with pre-existing asymptomatic folate deficiency developed nitrous oxide-induced folate deficiency .\
\
###10914847\
OBJECTIVE	A 6 month prospective randomized double blind study was conducted to investigate hydroxychloroquine dose concentration-effect relationships in people with rheumatoid arthritis .\
METHODS	Patients were randomized in 2 groups : one group received 200 mg hydroxychloroquine sulfate daily ( A ) and one group received 400 mg daily ( B ) .\
METHODS	Each month , 8 disease variables were assessed , adverse events recorded , and hydroxychloroquine blood concentrations determined .\
RESULTS	Twenty-three patients were included : 10 in group A and 13 in group B.\
RESULTS	After 6 months of therapy , a significant improvement in disease activity was noted for 6 criteria with no statistical differences between groups : pain ( assessed by a visual analog scale ) , joint scores ( swelling and tenderness ) , impairment in daily living activity ( 18 activities graded 0 to 8 ) , patient assessment of disease state , and erythrocyte sedimentation rate .\
RESULTS	Hydroxychloroquine steady-state blood concentrations ( Month 6 ) were significantly different between groups ( mean + / - SD ) : 450.6 + / - 285.3 ng/ml ( A ) vs 870.3 + / - 329.3 ng/ml ( B ) ( p = 0.0001 ) .\
RESULTS	Steady-state concentrations were correlated with the daily dose ( r = 0.63 , p = 0.005 ) , the improvement in activity of daily living ( r = 0.49 , p = 0.03 ) , and the improvement in joint tenderness score ( r = 0.47 , p = 0.038 ) .\
CONCLUSIONS	The data indicate that hydroxychloroquine is an effective therapy , but there were no further improvements observed in the group receiving 400 mg daily compared to those receiving 200 mg .\
CONCLUSIONS	There were some correlations between hydroxychloroquine steady-state blood concentrations and effects .\
\
###19727232\
OBJECTIVE	To explore the short-term treatment effect of the auditory integrative training on autistic children and provide them with clinical support for rehabilitative treatment .\
METHODS	A total of 81 cases of autistic children were selected through the standard of DSM-4 and clinical case study was used .\
METHODS	They were divided randomly into experimental group and control one , and respectively received auditory integrative training and no training based on the multiple therapies .\
METHODS	The patients were investigated using clinical manifestation and Autism Behavior Checklist ( ABC ) and intelligence quotient ( IQ ) before and after six months of treatment .\
METHODS	The effect was evaluated through the changes of clinical manifestations and scores of ABC and IQ .\
METHODS	The changes of scores of IQ were determined with Gesell and WPPSI or WISC-R .\
RESULTS	Compared with 40 patients of the control group after the six months of the auditory integrative training , 41 of the experimental group had greatly improved in many aspects , such as the disorders of their language , social interactions and typical behavior symptoms while they had not changed in their abnormal behaviors .\
RESULTS	The scores of IQ or DQ had increased and scores of ABC had dropped .\
RESULTS	The differences between the two groups were greatly significant in statistics ( P < 0.01 ) .\
RESULTS	The decreasing level of both ABC scores and the increasing level of the IQ scores were negatively correlated with age , and the decreasing level of ABC scores was in line regression ( positive correlation ) with base IQ .\
CONCLUSIONS	The treatment of auditory integrative training ( AIT ) could greatly improve on language disorders , the difficulties of social interactions , typical behavior symptoms and developmental levels , therefore it is positive to the autistic children in its short-term treatment effect .\
\
###21854144\
BACKGROUND	Self-reported commitment to change ( CTC ) could be a potentially valuable method to address the need for continuing medical education ( CME ) to demonstrate clinical outcomes .\
OBJECTIVE	This study determines : ( 1 ) are clinicians who make CTCs more likely to report changes in their medical practices and ( 2 ) do these changes persist over time ?\
METHODS	Intervention participants ( N = 80 ) selected up to three commitments from a predefined list following the lecture , while control participants ( N = 64 ) generated up to three commitments at 7 days post-lecture .\
METHODS	At 7 and 30 days post-lecture , participants were queried if any practice change occurred as a result of attending the lecture .\
RESULTS	About 91 % of the intervention group reported practice changes consistent with their commitments at 7 days .\
RESULTS	Only 32 % in the control group reported changes ( z = 7.32 , p < 0.001 ) .\
RESULTS	At 30 days , more participants in the intervention group relative to the control group reported change ( 58 % vs. 22 % , z = 3.74 , p < 0.01 ) .\
RESULTS	Once a participant from either group made a commitment , there were no differences in reported changes ( 63 % vs. 67 % , z = < 0.00 , p = 0.38 ) .\
CONCLUSIONS	Integration of CTC is an effective method of reinforcing learning and measuring outcomes .\
\
###24439986\
BACKGROUND	There are conflicting data on the use of cilostazol as triple antiplatelet therapy ( TAPT ) for improving clinical outcomes after drug-eluting stent implantation .\
BACKGROUND	We aimed to evaluate whether 3-month use of cilostazol in addition to dual antiplatelet therapy ( DAPT ) improved clinical outcomes in patients with long or multivessel coronary artery disease ( CAD ) after biolimus-eluting stent ( BES ) implantation .\
METHODS	Patients ( n = 630 ) who had been successfully treated with BES implantation for lesions with 28 mm in stent length or 2 stents for different coronary arteries were enrolled in this prospective randomized multicenter trial .\
METHODS	All patients were randomly assigned to receive either DAPT ( aspirin and clopidogrel for 12 months , n = 314 ) or TAPT ( DAPT plus 3-month cilostazol use , n = 316 ) .\
METHODS	The primary end point was a device-oriented composite consisting of cardiac death , myocardial infarction ( not clearly attributable to a nontarget vessel ) , and ischemia-driven target lesion revascularization at 1-year follow-up .\
RESULTS	A total of 314 patients in DAPT and 308 patients in TAPT were analyzed .\
RESULTS	Multivessel CAD was present in 65.7 % of patients .\
RESULTS	Stents 28 mm in length were implanted in 58.1 % of lesions .\
RESULTS	There were no significant differences in baseline and angiographic characteristics between the 2 groups .\
RESULTS	The primary end point was similar between the 2 groups ( 2.3 % in DAPT vs 1.9 % in TAPT , log-rank P = .799 ) .\
CONCLUSIONS	In patients treated with BES implantation for long or multivessel CAD , 3 months of cilostazol use in addition to DAPT did not improve clinical outcome at 1-year follow-up .\
\
###18523415\
BACKGROUND	We report on a double-blind , vehicle-controlled , single-center confirmatory study with random assignment .\
BACKGROUND	The purpose of the study was to investigate the topical bioavailability of different topical corticosteroid formulations in healthy human beings focussing on desoximetasone ( DM ) .\
METHODS	Two DM 0.25 % formulations [ ointment ( DM-o ) and fatty ointment ( DM-fo , water-free ) ; class III corticosteroids ] , the corresponding active ingredient-free vehicles and three comparators of different strength [ clobetasol propionate 0.05 % ( CP 0.05 % ) , fatty ointment , class IV ; hydrocortisone ( HC ) 1 % , fatty ointment , class I , and betamethasone ( BM ) 0.05 % , fatty ointment , class III ] were tested using the vasoconstriction assay .\
METHODS	The degree of vasoconstriction ( blanching ) in the treatment field was compared to the one found in untreated control fields using chromametric measurements and clinical assessment .\
CONCLUSIONS	DM-o 0.25 % , DM-fo 0.25 % and BM 0.05 % showed similar vasoconstrictive potential , i.e. , clear blanching .\
CONCLUSIONS	In fact , both DM preparations were proven to be noninferior to BM 0.05 % , while CP 0.05 % was found a little less active .\
CONCLUSIONS	HC 1.0 % and the DM vehicles showed no clear-cut vasoconstrictive effect .\
CONCLUSIONS	No adverse events related to the study medications were observed .\
CONCLUSIONS	Good topical bioavailability of both DM formulations was detected by chromametric measurement and clinical assessment .\
\
###15851890\
BACKGROUND	Epidural morphine has proven analgesic efficacy in the postoperative period and is widely used .\
BACKGROUND	This study evaluated the efficacy of extended-release epidural morphine ( EREM ; DepoDur ; Endo Pharmaceuticals Inc. , Chadds Ford , PA ; SkyePharma , Inc. , San Diego , CA ) in providing pain relief for 48 h after surgery .\
METHODS	Patients ( n = 200 ) scheduled to undergo total hip arthroplasty were randomized to receive a single dose of 15 , 20 , or 25 mg EREM or placebo .\
METHODS	After surgery and after asking for pain medication , patients had access to intravenous patient-controlled analgesia fentanyl for breakthrough pain as needed .\
METHODS	Postoperative intravenous patient-controlled analgesia fentanyl use , time to first postoperative fentanyl use , pain intensity at rest and with activity , patient and surgeon ratings of pain control , and adverse events were recorded .\
RESULTS	All EREM dosages reduced the mean ( + / - SD ) fentanyl use versus placebo ( 510 + / - 708 vs. 2,091 + / - 1,803 microg ; P < 0.0001 ) and delayed the median time to first dose of fentanyl ( 21.3 vs. 3.6 h ; P < 0.0001 ) .\
RESULTS	All EREM groups had significantly improved pain control at rest through 48 h postdose ( area under the curve [ 0-48 h ] ) compared with placebo ( P < 0.0005 ) .\
RESULTS	More EREM-treated patients rated their pain control as good or very good compared with placebo ( at 24 h : 90 vs. 65 % , P < 0.0001 ; at 48 h : 83 vs. 67 % , P < 0.05 ) .\
RESULTS	No supplemental analgesia was needed in 25 % of EREM-treated patients and 2 % of placebo-treated patients at 48 h ( P < 0.05 ) .\
RESULTS	The safety profile of EREM was consistent with that of other epidurally administered opioid analgesics .\
CONCLUSIONS	EREM provided significant postoperative pain relief over a 48-h period after hip surgery , without the need for indwelling epidural catheters .\
\
###16824148\
OBJECTIVE	Oral candidiasis occurs commonly in haematopoietic - stem cell transplantation ( HSCT ) patients carrying a risk of systemic candidemia and mortality .\
OBJECTIVE	The aim of this pilot study was to design an effective protocol that prevents oral candidiasis and improves tolerability .\
METHODS	A prospective , randomized , longitudinal study with two treatment groups , ( A ) chlorhexidine ( CHX ) and ( B ) CHX combined with medium-dose amphotericin B ( AMB ) , was performed .\
METHODS	The investigators were blinded to the treatment arm .\
RESULTS	No clinical signs of oral candidiasis were observed in any of the 20 patients .\
RESULTS	All patients experienced neutropenia and were treated with antibiotics .\
RESULTS	The duration of antibiotic treatment was longer in group A than that in group B.\
RESULTS	The difference in systemic anti-fungal treatment was insignificant .\
RESULTS	Compliance was achieved in both groups , although tolerability was better in group A than that in group B.\
CONCLUSIONS	Effective oral anti-fungal prevention based on topical AMB was suggested .\
CONCLUSIONS	CHX mouthwash was also suggested to be effective as a single topical agent for the prevention of oral candidiasis in HSCT patients .\
CONCLUSIONS	The combination of topical CHX and medium-dose AMB-prophylactic protocol may achieve the same level of candidial prevention with better tolerability than that by AMB alone .\
CONCLUSIONS	More research is warranted .\
\
###8635032\
BACKGROUND	This investigation examined factors affecting patient involvement in consultations to decide local treatment for early breast cancer and the effectiveness of two methods of preconsultation education aimed at increasing patient participation in these discussions .\
METHODS	Sixty patients with Stage I or II breast cancer ( 1 ) were pretested on their knowledge about breast cancer treatment and optimism for the future , ( 2 ) were randomly assigned to one of two methods for preconsultation education : interactive multimedia program or brochure , ( 3 ) completed knowledge and optimism measures , ( 4 ) consulted with a medical oncologist , radiation oncologist , and general surgeon , and ( 5 ) completed self-report measures assessing their involvement in the consultations and control over decision-making .\
METHODS	The consultations were audiorecorded and analyzed to identify behavioral indicators of patient involvement ( question-asking , opinion-giving , and expressing concern ) and physician utterances encouraging patient participation .\
RESULTS	College-educated patients younger than 65 years of age were more active participants in these consultations than were older , less educated patients .\
RESULTS	In addition , patients showed more involvement when they interacted with physicians who encouraged and facilitated patient participation .\
RESULTS	The method of education did not affect patient involvement although patients tended to learn more about breast cancer treatment after using the multimedia program than after reading the brochure .\
CONCLUSIONS	Although patients vary in their expressiveness , physicians may be able to increase patient participation in deciding treatment by using patient-centered behavior .\
CONCLUSIONS	Also , preconsultation education appears to be an effective clinical strategy for helping patients gain an accurate understanding of their treatment options before meeting with physicians .\
\
###22589422\
BACKGROUND	Smoking prevalence in homeless populations is strikingly high ( 70 % ) ; yet , little is known about effective smoking cessation interventions for this population .\
BACKGROUND	We conducted a community-based clinical trial , Power To Quit ( PTQ ) , to assess the effects of motivational interviewing ( MI ) and nicotine patch ( nicotine replacement therapy [ NRT ] ) on smoking cessation among homeless smokers .\
BACKGROUND	This paper describes the smoking characteristics and comorbidities of smokers in the study .\
METHODS	Four hundred and thirty homeless adult smokers were randomized to either the intervention arm ( NRT + MI ) or the control arm ( NRT + Brief Advice ) .\
METHODS	Baseline assessment included demographic information , shelter status , smoking history , motivation to quit smoking , alcohol/other substance abuse , and psychiatric comorbidities .\
RESULTS	Of the 849 individuals who completed the eligibility survey , 578 ( 68.1 % ) were eligible and 430 ( 74.4 % of eligibles ) were enrolled .\
RESULTS	Participants were predominantly Black , male , and had mean age of 44.4 years ( S D = 9.9 ) , and the majority were unemployed ( 90.5 % ) .\
RESULTS	Most participants reported sleeping in emergency shelters ; nearly half had been homeless for more than a year .\
RESULTS	Nearly all the participants were daily smokers who smoked an average of 20 cigarettes/day .\
RESULTS	Nearly 40 % had patient health questionnaire-9 depression scores in the moderate or worse range , and more than 80 % screened positive for lifetime history of drug abuse or dependence .\
CONCLUSIONS	This study demonstrates the feasibility of enrolling a diverse sample of homeless smokers into a smoking cessation clinical trial .\
CONCLUSIONS	The uniqueness of the study sample enables investigators to examine the influence of nicotine dependence as well as psychiatric and substance abuse comorbidities on smoking cessation outcomes .\
\
###24019551\
OBJECTIVE	The GM2 ganglioside is an antigen expressed in the majority of melanomas .\
OBJECTIVE	The GM2-KLH/QS -21 vaccine induces high immunoglobulin M ( IgM ) and IgG antibody responses .\
OBJECTIVE	The EORTC 18961 trial compared the efficacy of GM2-KLH/QS -21 vaccination versus observation .\
METHODS	A total of 1,314 patients with a primary tumor > 1.50 mm in thickness ( T3-4N0M0 ; American Joint Committee on Cancer stage II ) were randomly assigned to GM2-KLH/QS -21 vaccination ( n = 657 ) or observation ( n = 657 ) .\
METHODS	Treatment consisted of subcutaneous injections once per week from week 1 to 4 , then every 3 months for the first 2 years and every 6 months during the third year .\
METHODS	Primary end point was relapse-free survival ( RFS ) .\
METHODS	Secondary end points were distant metastasis-free survival ( DMFS ) and overall survival ( OS ) .\
METHODS	Analyses were by intent to treat .\
RESULTS	After a median follow-up of 1.8 years , the trial was stopped at the second interim analysis for futility regarding RFS ( hazard ratio [ HR ] , 1.00 ; P = .99 ) and detrimental outcome regarding OS ( HR , 1.66 ; P = .02 ) .\
RESULTS	After a median follow-up of 4.2 years , we had recorded 400 relapses , nine deaths without relapse , a total of 236 deaths .\
RESULTS	At 4 years , the vaccination arm showed a decreased RFS rate of 1.2 % ( HR , 1.03 ; 95 % CI , 0.84 to 1.25 ) and OS rate of 2.1 % ( HR , 1.16 ; 95 % CI , 0.90 to 1.51 ) .\
RESULTS	Toxicity was acceptable , with 4.6 % of patients ending study participation because of toxicity .\
CONCLUSIONS	GM2-KLH/QS -21 vaccination does not improve outcome for patients with stage II melanoma .\
\
###20594555\
OBJECTIVE	To assess the efficacy and safety of rosiglitazone on saphenous vein graft ( SVG ) atherosclerosis prevention and on modification of the global cardiometabolic risk profile .\
RESULTS	This was a double-blind , randomized , placebo-controlled , multicenter trial which enrolled 193 post-CABG patients with type 2 diabetes .\
RESULTS	Atherosclerosis changes in one SVG were assessed with intravascular ultrasound at baseline and at 12 months .\
RESULTS	Serial cardiometabolic assessments were performed .\
RESULTS	At baseline , both groups had mean HbA ( 1C ) < 7 % , LDL-cholesterol ( LDL-C ) < 2.3 mmol/l , HDL-cholesterol ( HDL-C ) > 1.0 mmol/l and blood pressure < 130/75 mmHg .\
RESULTS	After 12 months , plaque volume in SVG had increased ( median [ interquartile range ] ) by 7.7 mm ( 3 ) ( -17.2 to 37.9 ) in the placebo group and decreased by 0.3 mm ( 3 ) ( -19.1 to 22.3 ) in the rosiglitazone group ( P = 0.22 ) .\
RESULTS	Compared to placebo , rosiglitazone treated patients had a higher ( mean + or - SD ) body weight ( 89 + or - 15 kg vs. 84 + or - 15 kg , P = 0.02 ) at the end of the study , mostly related to an increment in subcutaneous adipose tissue .\
RESULTS	Rosiglitazone treated patients also displayed further improvements in glycemic control compared to placebo ( HbA ( 1C ) : 6.4 + or - 0.7 % vs. 7.0 + or - 0.9 % , P < 0.001 ) as well as in several cardiometabolic parameters such as lipids ( HDL-C : 1.16 + or - 0.28 mmol/l vs. 1.06 + or - 0.23 mmol/l , P = 0.003 ) , inflammatory profile ( C-reactive protein : 0.92 mg/l [ 0.51-1 .56 ] vs. 1.37 mg/l [ 0.79-3 .08 ] , P = 0.02 ) , and adiponectin levels ( 11.1 microg/ml [ 8.19-17 .9 ] vs. 4.65 microg/ml [ 3.27-7 .15 ] , P < 0.001 ) .\
RESULTS	There was no significant difference in the incidence of serious adverse cardiovascular events .\
RESULTS	However , more patients in the rosiglitazone group had peripheral oedema ( 33 % vs. 18 % , P = 0.0019 ) .\
CONCLUSIONS	After a 12-month follow-up , we found no evidence for a statistically significant effect of rosiglitazone on SVG atherosclerosis whereas significant effects on glycemic control and on the cardiometabolic risk profile appeared to be modulated in part by changes in subcutaneous adiposity .\
\
###17762645\
OBJECTIVE	Arterial transfer functions ( TFs ) describe the relationship between the pressure waveform at different arterial sites .\
OBJECTIVE	Generalized TFs are used to reconstruct central aortic waveforms from non-invasively obtained peripheral waveforms and have been promoted as potentially clinically useful .\
OBJECTIVE	A limitation is the paucity of information on their ` generalizability ' with no information existing on the number of subjects required to construct a satisfactory TF , nor is adequate prospective validation available .\
OBJECTIVE	We therefore investigated the uniformity of radial-aortic TFs and prospectively estimated the capacity of a generalized TF to reconstruct individual central blood pressure parameters .\
METHODS	Ninety-three subjects ( 64 male ) were studied by simultaneous radial applanation and high-fidelity ( Millar Mikro-tip catheter ) direct measurement of central aortic BP during elective coronary procedures .\
METHODS	Subjects were prospectively randomized to either a derivation or validation group .\
RESULTS	Increasing numbers of individual TFs from the derivation group were averaged to form a generalized TF .\
RESULTS	There was minimal change with greater than 20 TFs averaged .\
RESULTS	In the validation group , the error in most reconstructed parameters related to the absolute value of the directly measured parameter [ systolic blood pressure ( SBP ) and pulse pressure , P < 0.05 ; systolic pressure-time interval , subendocardial viability index , augmentation index , and times to the inflection point , peak and end systole , all P < 0.01 ] .\
RESULTS	Aorto-radial delay was related to error in reconstructed central aortic SBP and pulse pressure ( negatively ) and time to peak systole ( positively ) ( all P < 0.001 ) .\
RESULTS	Reconstruction of augmentation index was poor .\
CONCLUSIONS	Inclusion of more than 20 individual TFs in the construction of a generalized TF does not improve ` generalizability ' .\
CONCLUSIONS	There appear to be systematic errors in derived central pressure waveforms and derived aortic augmentation index is inaccurate compared to the directly measured value .\
\
###12193353\
OBJECTIVE	To determine whether local warming of the lower arm and hand facilitates peripheral venous cannulation .\
METHODS	Single blinded prospective randomised controlled trial and single blinded randomised crossover trial .\
METHODS	Neurosurgical unit and haematology ward of university hospital .\
METHODS	100 neurosurgical patients and 40 patients with leukaemia who required chemotherapy .\
METHODS	Neurosurgical patients ' hands and forearms were covered for 15 minutes with a carbon fibre heating mitt .\
METHODS	Patients were assigned randomly to active warming at 52 degrees C or passive insulation ( heater not activated ) .\
METHODS	The same warming system was used for 10 minutes in patients with leukaemia .\
METHODS	They were assigned randomly to active warming or passive insulation on day 1 and given alternative treatment during the subsequent visit .\
METHODS	PRIMARY : success rate for insertion of 18 gauge cannula into vein on back of hand .\
METHODS	SECONDARY : time required for successful cannulation .\
RESULTS	In neurosurgical patients , it took 36 seconds ( 95 % confidence interval 31 to 40 seconds ) to insert a cannula in the active warming group and 62 ( 50 to 74 ) seconds in the passive insulation group ( P = 0.002 ) .\
RESULTS	Three ( 6 % ) first attempts failed in the active warming group compared with 14 ( 28 % ) in the passive insulation group ( P = 0.008 ) .\
RESULTS	The crossover study in patients with leukaemia showed that insertion time was reduced by 20 seconds ( 8 to 32 , P = 0.013 ) with active warming and that failure rates at first attempt were 6 % with warming and 30 % with passive insulation ( P < 0.001 ) .\
CONCLUSIONS	Local warming facilitates the insertion of peripheral venous cannulas , reducing both time and number of attempts required .\
CONCLUSIONS	This may decrease the time staff spend inserting cannulas , reduce supply costs , and improve patient satisfaction .\
\
###24066730\
BACKGROUND	Cardiovascular diseases ( CVDs ) are one of the leading causes of death and disability in the world .\
BACKGROUND	Over 80 % of CVD deaths take place in low-and middle-income countries .\
BACKGROUND	One-third of the population aged above 40years suffers from Hypertension ( HTN ) and this is largely unreported as there is no registry for CVDs .\
BACKGROUND	No guidelines are available for use in health care facilities , especially private health facilities where practice among GPs varies considerably .\
BACKGROUND	We aim to conduct a Cluster Randomized Controlled trial delivering a quality HTN-CVD care package at strengthened private health facilities as compared to current practice at private health facilities .\
METHODS	A pragmatic cluster randomized trial , with qualitative and economic studies , will be conducted in Sargodha district of Punjab , Pakistan , from January 2012 to December 2016 .\
METHODS	At least 912 hypertensives will be registered in the two arms , six clusters per arm .\
METHODS	The proposed cluster randomized controlled trial will evaluate the effects of delivering quality HTN-CVD care , through enabled private health care facilities , to achieve better case registration , adherence and hypertension control also blood glucose and serum cholesterol control .\
METHODS	The trial will be conducted through the doctors and paramedics at private health facilities .\
METHODS	Main outcomes are mean difference in Systolic blood pressure among the two arms .\
METHODS	Secondary outcomes are mean change in total serum cholesterol levels and mean change in glycaemic control achieved in the adult hypertensive patients .\
METHODS	Individual and Cluster level analysis will be done according to intention-to-treat .\
CONCLUSIONS	Due to the high burden of disease where 1 in 3 individuals aged above 45 suffers from hypertension , topped with the fact that there is a dearth of a set of available , standardised guidelines for management , the disease is constantly on a hike in Pakistan .\
CONCLUSIONS	The government has made no effort to issue a set of guidelines adapted specifically for our population and this becomes more of a problem when managing CVD in urban population through private practitioners whose practices vary widely.If our set of context sensitive guidelines show an effectiveness in the proposed intervention districts it will be replicated in other such settings .\
BACKGROUND	Current Controlled Trials ISRCTN34381594 .\
\
###25209926\
OBJECTIVE	To evaluate the effectiveness of 200 mg of daily vaginal natural progesterone to prevent preterm birth in women with preterm labour .\
METHODS	Multicentre , randomised , double-blind , placebo-controlled trial .\
METHODS	Twenty-nine centres in Switzerland and Argentina .\
METHODS	A total of 385 women with preterm labour ( 24 ( 0/7 ) to 33 ( 6/7 ) weeks of gestation ) treated with acute tocolysis .\
METHODS	Participants were randomly allocated to either 200 mg daily of self-administered vaginal progesterone or placebo within 48 hours of starting acute tocolysis .\
METHODS	Primary outcome was delivery before 37 weeks of gestation .\
METHODS	Secondary outcomes were delivery before 32 and 34 weeks , adverse effects , duration of tocolysis , re-admissions for preterm labour , length of hospital stay , and neonatal morbidity and mortality .\
METHODS	The study was ended prematurely based on results of the intermediate analysis .\
RESULTS	Preterm birth occurred in 42.5 % of women in the progesterone group versus 35.5 % in the placebo group ( relative risk [ RR ] 1.2 ; 95 % confidence interval [ 95 % CI ] 0.93-1 .5 ) .\
RESULTS	Delivery at < 32 and < 34 weeks did not differ between the two groups ( 12.9 versus 9.7 % ; [ RR 1.3 ; 95 % CI 0.7-2 .5 ] and 19.7 versus 12.9 % [ RR 1.5 ; 95 % CI 0.9-2 .4 ] , respectively ) .\
RESULTS	The duration of tocolysis , hospitalisation , and recurrence of preterm labour were comparable between groups .\
RESULTS	Neonatal morbidity occurred in 44 ( 22.8 % ) cases on progesterone versus 35 ( 18.8 % ) cases on placebo ( RR : 1.2 ; 95 % CI 0.82-1 .8 ) , whereas there were 4 ( 2 % ) neonatal deaths in each study group .\
CONCLUSIONS	There is no evidence that the daily administration of 200 mg vaginal progesterone decreases preterm birth or improves neonatal outcome in women with preterm labour .\
\
###26406148\
BACKGROUND	Nivolumab , a programmed death 1 ( PD-1 ) checkpoint inhibitor , was associated with encouraging overall survival in uncontrolled studies involving previously treated patients with advanced renal-cell carcinoma .\
BACKGROUND	This randomized , open-label , phase 3 study compared nivolumab with everolimus in patients with renal-cell carcinoma who had received previous treatment .\
METHODS	A total of 821 patients with advanced clear-cell renal-cell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy were randomly assigned ( in a 1:1 ratio ) to receive 3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks or a 10-mg everolimus tablet orally once daily .\
METHODS	The primary end point was overall survival .\
METHODS	The secondary end points included the objective response rate and safety .\
RESULTS	The median overall survival was 25.0 months ( 95 % confidence interval [ CI ] , 21.8 to not estimable ) with nivolumab and 19.6 months ( 95 % CI , 17.6 to 23.1 ) with everolimus .\
RESULTS	The hazard ratio for death with nivolumab versus everolimus was 0.73 ( 98.5 % CI , 0.57 to 0.93 ; P = 0.002 ) , which met the prespecified criterion for superiority ( P0 .0148 ) .\
RESULTS	The objective response rate was greater with nivolumab than with everolimus ( 25 % vs. 5 % ; odds ratio , 5.98 [ 95 % CI , 3.68 to 9.72 ] ; P < 0.001 ) .\
RESULTS	The median progression-free survival was 4.6 months ( 95 % CI , 3.7 to 5.4 ) with nivolumab and 4.4 months ( 95 % CI , 3.7 to 5.5 ) with everolimus ( hazard ratio , 0.88 ; 95 % CI , 0.75 to 1.03 ; P = 0.11 ) .\
RESULTS	Grade 3 or 4 treatment-related adverse events occurred in 19 % of the patients receiving nivolumab and in 37 % of the patients receiving everolimus ; the most common event with nivolumab was fatigue ( in 2 % of the patients ) , and the most common event with everolimus was anemia ( in 8 % ) .\
CONCLUSIONS	Among patients with previously treated advanced renal-cell carcinoma , overall survival was longer and fewer grade 3 or 4 adverse events occurred with nivolumab than with everolimus .\
CONCLUSIONS	( Funded by Bristol-Myers Squibb ; CheckMate 025 ClinicalTrials.gov number , NCT01668784 . )\
\
###17397734\
OBJECTIVE	To use trypan blue as a quantifiable ingress tracer to determine whether stromal hydration reduces ocular surface fluid ingress at the end of phacoemulsification .\
METHODS	Iladevi Cataract and IOL Research Centre , Memnagar , Ahmedabad , India .\
METHODS	A prospective randomized study included 80 eyes having phacoemulsification through 2.2 mm incisions .\
METHODS	These eyes were divided into 2 equal groups : 1 had stromal hydration ( surgery completed by injecting fortified balanced salt solution [ BSS Plus ] to hydrate the lateral walls and internal entry of incision ) and the other had no stromal hydration .\
METHODS	One half milliliter of 0.0125 % sterile trypan blue was instilled on the ocular surface and allowed to remain for 2 minutes .\
METHODS	One-tenth milliliter of aqueous fluid was aspirated from the anterior chamber , and its optical density was measured using ultraviolet spectrophotometry .\
METHODS	Logs of dilution of trypan blue were used for statistical analysis using the nonparametric Mann-Whitney U test .\
RESULTS	There was a statistically significant decrease and difference between groups in mean dilution of trypan blue in the aqueous aspirate ( P < .001 ) .\
RESULTS	The mean was 1:11,337 in the stromal hydration group and 1:220 in the no stromal hydration group .\
RESULTS	Logs of mean dilution of trypan blue had statistically significant lower values in the stromal hydration group than in the no stromal hydration group ( 3.21 and 2.14 , respectively ) ( P < .001 ) .\
CONCLUSIONS	Stromal hydration of clear corneal incisions reduced ingress into the anterior chamber of the trypan blue instilled on the ocular surface .\
CONCLUSIONS	Clinically , these findings may have a beneficial effect in reducing the risk for postoperative endophthalmitis .\
\
###12629374\
OBJECTIVE	We analyze subjective changes , morbidity and mortality in men with lower urinary tract symptoms associated with benign prostatic hyperplasia ( BPH ) after transurethral resection of the prostate , contact laser prostatectomy and electrovaporization .\
METHODS	A prospective , randomized controlled trial was conducted on men with lower urinary tract symptoms , who met the criteria of the International Scientific Committee on BPH , had a prostate volume between 20 and 65 ml. , and had Schfer 's obstruction grade 2 or greater .\
METHODS	Objective morbidity was recorded for up to 12 months .\
METHODS	Subjective morbidity was measured by a questionnaire completed by patients .\
METHODS	Subjective changes were quantified using the International Prostate Symptom Score , Symptom Problem Index , Quality of Life question and BPH Impact Index .\
METHODS	These indexes and the morbidity questionnaire were measured weekly for the first 6 weeks postoperatively and then at 3 , 6 and 12 months .\
RESULTS	Transurethral prostatic resection was analyzed in 50 men , laser treatment in 45 and electrovaporization in 46 .\
RESULTS	Baseline characteristics , and changes in the symptom scores up to 12 months postoperatively were similar .\
RESULTS	Perioperative blood loss and perforation were greatest in the resection group , and retention was greatest in the laser group .\
RESULTS	During the first 6 postoperative weeks there was less pain and less hematuria after resection , and less incontinence after laser prostatectomy .\
CONCLUSIONS	Subjective changes are similar for transurethral prostatic resection , contact laser and electrovaporization .\
CONCLUSIONS	In the first 6 weeks after treatment there are only slight differences in pain , hematuria and incontinence among the therapies .\
\
###24613271\
OBJECTIVE	The effects of nutritional management among other intervention components have not been examined for hip-fractured elderly persons with poor nutritional status .\
OBJECTIVE	Accordingly , this study explored the intervention effects of an in-home program using a comprehensive care model that included a nutrition-management component on recovery of hip-fractured older persons with poor nutritional status at hospital discharge .\
METHODS	A secondary analysis of data from a randomized controlled trial with 24-month follow-up .\
METHODS	A 3000-bed medical center in northern Taiwan .\
METHODS	Subjects were included only if they had `` poor nutritional status '' at hospital discharge , including those at risk for malnutrition or malnourished .\
METHODS	The subsample included 80 subjects with poor nutritional status in the comprehensive care group , 87 in the interdisciplinary care group , and 85 in the usual care group .\
METHODS	The 3 care models were usual care , interdisciplinary care , and comprehensive care .\
METHODS	Usual care provided no in-home care , interdisciplinary care provided 4 months of in-home rehabilitation , and comprehensive care included management of depressive symptoms , falls , and nutrition as well as 1 year of in-home rehabilitation .\
METHODS	Data were collected on nutritional status and physical functions , including range of motion , muscle power , proprioception , balance and functional independence , and analyzed using a generalized estimating equation approach .\
METHODS	We also compared patients ' baseline characteristics : demographic characteristics , type of surgery , comorbidities , length of hospital stay , cognitive function , and depression .\
RESULTS	Patients with poor nutritional status who received comprehensive care were 1.67 times ( 95 % confidence interval 1.06-2 .61 ) more likely to recover their nutritional status than those who received interdisciplinary and usual care .\
RESULTS	Furthermore , the comprehensive care model improved the functional independence and balance of patients who recovered their nutritional status over the first year following discharge , but not of those who had not yet recovered .\
CONCLUSIONS	An in-home program using the comprehensive care model with a nutritional component effectively improved the nutritional status of hip-fractured patients with poor nutrition .\
CONCLUSIONS	This comprehensive care intervention more effectively improved recovery of functional independence and balance for patients with recovered nutritional status .\
\
###19566902\
BACKGROUND	Severe generalized spastic movement disorders of various aetiologies often involve the jaw muscles and lead to a spastic trismus with masseter muscle hypertonia .\
BACKGROUND	We report a placebo-controlled randomized study on patients with spastic trismus .\
METHODS	Eleven patients with masseter hypertonia because of stroke , hypoxic encephalopathy or traumatic brain injury were allocated to either botulinum toxin serotype B ( BoNT/B ) injections into the masseter muscles or placebo treatment .\
METHODS	The dental gap , the amount of saliva , salivation scales , and a clinical goal attainment were evaluated .\
RESULTS	Three weeks after injection the BoNT/B group showed a significantly increased mouth opening compared with placebo treatment ( P < 0.05 ) .\
RESULTS	In addition to the muscle paralysing effect , a goal attainment scale demonstrated a clinical benefit for the BoNT/B group ( P < 0.01 ) .\
CONCLUSIONS	Botulinum toxin serotype B injections into the masseter muscles effectively reduce hypertonia and provide for better mouth opening , thereby contributing to a positive and desired clinical goal .\
\
###21793278\
OBJECTIVE	To compare advantages and disadvantages of exteriorized and in situ repair techniques of uterine incision during cesarean section .\
METHODS	A total of 338 patients delivered by cesarean section were included in the study .\
METHODS	Patients were randomized according to the location of uterine incision repair ; the uterus was exteriorized ( n = 171 ) or not ( in situ repair group ) ( n = 167 ) during cesarean section .\
METHODS	Two groups were compared in terms of blood loss , operation time , temperature patterns , analgesic dosage , length of hospital stay , incidence of nausea and vomiting .\
RESULTS	There was no significant difference in postoperative analgesic dosage , temperature patterns , drops in hemoglobin or hematocrit levels and in the incidence of postoperative nausea and vomiting between the two groups .\
RESULTS	Operation time and length of hospital stay were significantly shorter in the in situ repair group , when it was compared to those of which the uterus was exteriorized ( 30.64 + / - 8.65 vs 33.02 + / - 9.54 min. , p = 0.011 and 2.23 + / - 0.49 vs 2.45 + / - 0.94 days , p = 0.045 ) .\
CONCLUSIONS	Exteriorized and in situ repair of uterine incisions have similar effects on blood loss , temperature patterns , postoperative analgesic dosage and the incidence of postoperative nausea and vomiting .\
CONCLUSIONS	Although both methods of uterine incision repair are valid options during surgery , cesarean sections took less time and length of hospital stay was shorter when uterine incision was repaired in situ .\
\
###10671629\
OBJECTIVE	The purpose of this study was to determine the short-term effect of feeding selenium-supplemented formulas on the selenium status of end-stage renal disease patients on hemodialysis .\
METHODS	The prospective , randomized , single-blind study of parallel design was conducted at three hemodialysis clinics .\
METHODS	A total of 79 hemodialysis patients were randomly assigned into one of three groups .\
METHODS	Liquid nutritional formula supplemented with either selenite ( 28 microg Se/8 oz , n = 26 ) , selenate ( 28 microg Se/8 oz , n = 26 ) , or nonfortified ( 7 microg Se/8 oz , n = 27 ) was fed to hemodialysis patients as their sole source of nutrition for 14 days .\
METHODS	Plasma and red blood cell ( RBC ) selenium and glutathione peroxidase ( GPX ) activities were measured in predialysis blood both before ( day 1 ) and after ( day 8 ) a 7-day baseline period , and after subjects received the formula as the sole source of nutrition ( approximately 35 kcal/kg/d ) for 14 days ( day 22 ) .\
RESULTS	Selenium intake ( Mean + / - SEM , microg/d ) was 134 + / - 9 , 140 + / - 9 , and 35 + / - 2 for patients receiving selenite - , selenate - , or non-supplemented formula , respectively .\
RESULTS	On day 22 , plasma selenium ( micromol/L ) was greater ( P < .032 ) in the selenate-supplemented group ( 1.5 + / - 0.1 ) compared with the nonsupplemented group ( 1.2 + / - 0.1 ) , but not compared with the selenite-supplemented group ( 1.4 + / - 0.1 ) .\
RESULTS	Plasma GPX activity was 44 % to 60 % that of healthy controls and not different among groups .\
RESULTS	RBC selenium and GPX activities were within the normal range and were not different among groups .\
CONCLUSIONS	The results of this study indicate that a liquid formula supplemented with selenium as selenate is successful at maintaining selenium concentrations within normal range , as well as significantly increasing plasma selenium levels compared with nonsupplementation .\
\
###11115196\
BACKGROUND	Little data exist on the cause and treatment of subfacial pain and pressure and other discomfort attributed to the paranasal sinuses that develop early during the course of the common cold .\
BACKGROUND	The purpose of this study was to determine the efficacy of the combination of pseudoephedrine hydrochloride with acetaminophen for the treatment of early symptoms during colds , which are attributed by the patient to the sinuses .\
METHODS	Four hundred thirty subjects ( 216 , pseudoephedrine and acetaminophen recipients ; 214 , placebo recipients ) with cold symptoms of 48 hours or less who reported overall `` sinus '' symptoms of at least moderate severity were enrolled in this randomized double-blind placebo-controlled 2-dose study .\
METHODS	Self-reported symptoms were scored ( 0 to 4 , absent to severe ) before and at 2 hours after the first and second doses .\
METHODS	The 2 primary were measured 2 hours after the second dose were the overall sinus symptom assessment and a weighted composite assessment of sinus pressure , pain , and congestion ( sinus symptoms ) .\
RESULTS	Compared with baseline , 2 hours after the second dose , the mean + / - SEM overall sinus symptom assessment score had decreased by 1.30 + / - 0.06 in the pseudoephedrine and acetaminophen-treated subjects compared with 0.93 + / - 0.06 in the placebo-treated subjects ( P < or = .029 ) .\
RESULTS	The mean + / - SEM weighted average of sinus symptoms 2 hours after the second dose of study medication had decreased by 1.14 + / - 0.06 in the pseudoephedrine and acetaminophen-treated subjects compared with 0.84 + / - 0.06 in the placebo-treated subjects ( P < or = .029 ) .\
RESULTS	Reductions in similar magnitude were also observed for each of the individual sinus symptoms , and headache and rhinorrhea .\
RESULTS	Nervousness occurred in 4 % of the pseudoephedrine and acetaminophen recipients compared with 0 % of placebo recipients ( P = .007 ) .\
CONCLUSIONS	Our results suggest that pseudoephedrine plus acetaminophen is effective for relief of symptoms attributable to the paranasal sinuses that may develop early in the course of a cold .\
CONCLUSIONS	Arch Fam Med .\
CONCLUSIONS	2000 ; 9:979 -985\
\
###23747759\
OBJECTIVE	This study assessed pharmacodynamic ( PD ) response to the reduced prasugrel maintenance dose of 5 mg in very elderly ( VE ) patients ( 75 years of age ) .\
BACKGROUND	In the TRITON-TIMI 38 ( TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel-Thrombolysis In Myocardial Infarction 38 ) study prasugrel 10 mg reduced ischemic events versus clopidogrel 75 mg , but increased bleeding in VE patients .\
METHODS	We examined PD and active metabolite pharmacokinetics ( PKs ) with prasugrel 5 and 10 mg and clopidogrel 75 mg in a 3-period ( 12 days each ) blinded , crossover study in VE ( n = 73 ; mean : 79 3 years of age ) or ( n = 82 ) nonelderly ( NE ) ( 45 to < 65 years of age ; mean : 56 5 years of age ) stable coronary artery disease ( CAD ) patients receiving background aspirin .\
METHODS	Assays included light transmission aggregometry ( LTA ) , VerifyNow P2Y12 ( VN-P2Y12 ) , and vasodilator-associated stimulated phosphoprotein ( VASP ) .\
METHODS	The primary comparison was noninferiority of maximum platelet aggregation ( MPA ) comparing the median for prasugrel 5 mg in VE versus the 75th percentile for prasugrel 10 mg in NE , using a pre-specified 1-sided 97.5 % confidence interval for the difference < 15 % .\
RESULTS	Prasugrel 5 mg in VE met the primary PD noninferiority criterion versus prasugrel 10 mg in NE .\
RESULTS	For prasugrel 5 mg , MPA was significantly lower ( 57 14 % ) than clopidogrel ( 63 14 % ; p < 0.001 ) in VE but higher than prasugrel 10 mg in NE ( 46 12 % ; p < 0.001 ) .\
RESULTS	PD response by LTA , VN-P2Y12 , and VASP during all treatments appeared similar between age cohorts .\
RESULTS	Prasugrel 5 mg resulted in fewer VE poor responders than clopidogrel .\
RESULTS	Rates of mild bleeding were higher with prasugrel 10 mg but similar for prasugrel 5 mg versus clopidogrel 75 mg .\
CONCLUSIONS	In aspirin-treated stable CAD patients , prasugrel 5 mg in VE attenuated platelet inhibition while meeting pre-specified noninferiority criterion versus prasugrel 10 mg in NE , with significantly better PD response and fewer poor responders compared to clopidogrel 75 mg in VE .\
CONCLUSIONS	( Comparison of Prasugrel and Clopidogrel in Very Elderly and Non-Elderly Patients With Stable Coronary Artery Disease [ GENERATIONS ] ; NCT01107912 ) .\
\
###16160589\
OBJECTIVE	Non-selective alpha-adrenoceptor antagonists have not demonstrated significant beneficial effects in chronic heart failure .\
OBJECTIVE	Previous studies with the selective alpha1-adrenoceptor antagonist , doxazosin , led to conflicting results .\
OBJECTIVE	We assessed the hypothesis that treatment with doxazosin adjuvant to standard oral therapy results in significant increase in cardiac index in patients with chronic heart failure .\
METHODS	A double-blind , randomized study was conducted on 30 patients with chronic congestive heart failure ( NYHA III-IV ) , with cardiac index < 2.5 l/minxm , and/or with pulmonary capillary wedge pressure > 16 mm Hg .\
METHODS	Of the 30 patients , 15 were treated with doxazosin and 15 with placebo , both adjuvant to stable oral therapy , which included a minimum of an ACE inhibitor and a diuretic .\
METHODS	Hemodynamic measurements were performed on days 1 and 2 , and after 12 weeks on study medication .\
METHODS	On day 1 , patients were treated with 4 mg doxazosin or placebo .\
METHODS	On day 2 and throughout the following 12 weeks , the patients were treated with 4 mg or 8 mg doxazosin/d ( the latter , if 4 mg/d did not induce an increase > 0.75 l/minxm in cardiac index ) , or with placebo .\
RESULTS	Six patients were treated with 4 mg doxazosin/d ( group A ) , 9 patients with 8 mg doxazosin/d ( group B ) , and 15 with placebo .\
RESULTS	Baseline values for the cardiac index on day 1 , day 2 , and after 12 weeks failed to disclose significant differences between patient groups and between the days of study .\
RESULTS	On day 1 , the increase in cardiac index compared with baseline was significantly higher in group A than in the placebo group ( P = 0.004 ) and group B ( P = 0.001 ) .\
RESULTS	On day 2 , the increase in cardiac index compared with baseline on day 1 was significantly higher in group A than in group B ( P = 0.003 ) ( with reference to alpha/3 = 0.0167 according to Bonferroni ) .\
RESULTS	This was no longer observed after 12 weeks .\
RESULTS	In the placebo group , following significant changes occurred in baseline values , heart rate was lower ( P = 0.023 ) and stroke volume index was higher after 12 weeks in comparison to day 1 ( P = 0.032 ) .\
CONCLUSIONS	In conclusion , oral application of doxazosin supplementary to standard oral medication did not induce sustained hemodynamic benefit .\
CONCLUSIONS	Significant acute increase in cardiac index was observed in a minority ( 40 % ) of patients , whereas favorable changes in baseline hemodynamic parameters after 12 weeks occurred in the placebo group .\
\
###18198642\
OBJECTIVE	To analyse the cartilage erosion related blood biochemical and immune factors in rheumatoid arthritis ( RA ) and to explore the special influences of Chinese medicine ( CM ) and Western medicine ( WM ) on these factors .\
METHODS	Three hundred and ninety-seven patients , with confirmed diagnosis of active RA , were randomly assigned to the WM group ( 194 patients ) and the CM group ( 203 patients ) .\
METHODS	The WM applied covered non-steroid anti-inflammatory agents and slow acting medicine ; and the CM given included basic remedy and syndrome differentiating medication .\
METHODS	Related blood biochemical and immunological indexes were determined before and after treatment to screen out the cartilage erosion related factors and to compare the influence of CM and WM on them .\
RESULTS	Patients ' peripheral red blood cell ( RBC ) and platelet ( PLT ) count were changed closely along with their degree of cartilage erosion .\
RESULTS	RBC count increased in the CM group and PLT count lowered in the WM group after treatment , all showed statistical significance ; comparison of the two indexes between the two groups showed that statistical difference presented in RBC but not in PLT count .\
CONCLUSIONS	Both WM and CM can ameliorate the cartilage erosive factor in RA , but they are acting in different ways .\
\
###23352440\
BACKGROUND	Quality of life ( QoL ) after breast cancer is nowadays a major challenge .\
BACKGROUND	Complementary interventions are necessary because of frequent depression symptoms after treatment and also to favour return to activity .\
BACKGROUND	Besides , radio-chemotherapy has side-effects like weight gain and fatigue .\
BACKGROUND	Several strategies including group behavioural-educational interventions , physical training and/or dietary education , have been tested to answer these difficulties with moderate success in the long run .\
METHODS	Two hundred and fifty-one non-metastatic patients were accrued after chemotherapy in a prospective randomised multicenter trial between 2008 and 2010 , testing a 2-week intervention in SPA centres .\
METHODS	Intervention comprised group physical training , dietary education and physiotherapy .\
METHODS	Selected patients were in complete remission .\
METHODS	QoL was evaluated with SF36 questionnaire , anxiety and depression with the hospital anxiety and depression ( HAD ) one .\
METHODS	Anthropometric measures and QoL evaluations were obtained before randomisation and every 6 months during 3 years .\
RESULTS	Two hundred and twenty patients were evaluable at 1 year .\
RESULTS	Intervention increased SF36 score by 9.5 points ( p = 0.000006 ) , 4.6 ( p = 0.032 ) and 6.2 ( p = 0.028 ) respectively at 6 , 12 and 24 months .\
RESULTS	Effect size ( ES ) was 0.63 [ 0.37 ; 0.90 ] , 0.29 [ 0.03 ; 0.55 ] and 0.41 [ 0.04 ; 0.78 ] .\
RESULTS	Anxiety score was shortly minored by intervention ( 6-month ES = -0.24 [ -0.42 ; -0.05 ] ) and depression score more durably : ES = -0.45 [ -0.72 ; -0.18 ] , -0.34 [ -061 ; -0.08 ] , and -0.26 [ -0.63 ; 0.11 ] at 6 , 12 and 24 months .\
CONCLUSIONS	This 2-week group intervention seemed to durably influence QoL of breast cancer patients treated by chemotherapy .\
CONCLUSIONS	Differences , smaller at 12 months than at six , suggest that a second but shorter intervention could help maintain the 6-month benefits .\
\
###24102480\
OBJECTIVE	This study examined the feasibility of conducting a randomized controlled trial of acupuncture compared with an active control in an inpatient setting , to examine individuals ' experience of the interventions , clinical outcomes from the trial , and to integrate data to explain the trial findings .\
METHODS	This was a pilot randomized controlled trial with in-depth interviews with trial participants .\
METHODS	The study was conducted at a private medical facility in Sydney , Australia .\
METHODS	Twenty-six ( 26 ) patients with anorexia nervosa who were medically stable were the subjects .\
METHODS	Treatment as usual was administered , and the intervention was delivered twice a week for the first 3 weeks , followed by weekly treatment for three weeks .\
METHODS	The acupuncture group received acupuncture at the points Hegu ( LI4 ) , Zusanli ( ST36 ) , Neiguan ( PC6 ) , Taichong ( LR3 ) , Yanglingquan ( GB34 ) , and additional points based on the Traditional Chinese Medicine diagnosis .\
METHODS	The control group received acupressure and massage .\
METHODS	Acupressure involved consciously and gradually directing pressure to the center of the point being worked on .\
METHODS	Clinical outcomes were measured at baseline and at 6 weeks following completion of the intervention .\
METHODS	The primary outcome measure was body-mass index ( BMI ) , and secondary outcomes included eating disorder psychopathology , anxiety , and depression .\
METHODS	A semistructured interview was conducted asking questions about their interaction with the practitioner , what happened , how they felt , whether it made them feel differently , and what they attributed any change to .\
RESULTS	We found timely recruitment with the population recruited within a 5-month period .\
RESULTS	Study dropouts were 23 % and treatment compliance was moderate , but acceptable for this challenging population .\
RESULTS	Participants in the control group demonstrated reduced eating concerns .\
RESULTS	Participants described both interventions positively , and experienced a sense of calmness and relaxation .\
CONCLUSIONS	Acupuncture and acupressure and massage may improve the patient 's subjective sense of wellbeing , and further research is needed .\
\
###20463310\
OBJECTIVE	To compare the effectiveness of upper punctal occlusion versus that of lower punctal occlusion in dry eye patients .\
METHODS	One eye 's upper punctum and the contralateral eye 's lower punctum were occluded with collagen plugs in 20 dry eye patients .\
METHODS	The same procedure was performed in 20 normal subjects .\
METHODS	The upper and lower tear menisci were imaged simultaneously by real-time OCT before punctal occlusion and repeated on days 1 , 4 , 7 , and 10 afterward .\
METHODS	The subjective symptom score , corneal fluorescein staining intensity , Schirmer I test result , and tear breakup time ( TBUT ) were also determined .\
RESULTS	In dry eye patients , occlusion of either punctum improved symptom scores , fluorescein staining scores , TBUT , and lower tear meniscus height ( LTMH , P < 0.05 ) ; however , Schirmer test scores and upper tear meniscus height ( UTMH ) did not change after occlusion ( P > 0.05 ) .\
RESULTS	There was no significant difference for any of these variables between upper punctum - and lower punctum-occluded eyes , before or after occlusion ( P > 0.05 ) .\
RESULTS	In normal subjects , Schirmer test scores , TBUT , UTMH , and LTMH did not change over time ( P > 0.05 ) .\
CONCLUSIONS	Punctal occlusion with collagen plugs in dry eye patients leads to the relief of subjective symptoms and the improvement of objective signs .\
CONCLUSIONS	The effectiveness of occluding the upper or lower punctum is similar .\
CONCLUSIONS	The LTMH is a valid indicator of the success of punctal occlusion .\
\
###25077855\
OBJECTIVE	Religious involvement may help individuals with chronic medical illness cope better with physical disability and other life changes .\
OBJECTIVE	We examine the relationships between religiosity , depressive symptoms , and positive emotions in persons with major depression and chronic illness .\
METHODS	129 persons who were at least somewhat religious/spiritual were recruited into a clinical trial to evaluate the effectiveness of religious vs. secular cognitive behavioral therapy .\
METHODS	Reported here are the relationships at baseline between religious involvement and depressive symptoms , purpose in life , optimism , generosity , and gratefulness using standard measures .\
RESULTS	Although religiosity was unrelated to depressive symptoms ( F = 0.96 , p = 0.43 ) and did not buffer the disability-depression relationship ( B = -1.56 , SE 2.90 , p = 0.59 ) , strong relationships were found between religious indicators and greater purpose , optimism , generosity , and gratefulness ( F = 7.08 , p < 0.0001 ) .\
CONCLUSIONS	Although unrelated to depressive symptoms in the setting of major depression and chronic medical illness , higher religious involvement is associated with positive emotions , a finding which may influence the course of depression over time .\
\
###23883616\
BACKGROUND	Alcohol consumption in the student population continues to be cause for concern .\
BACKGROUND	Building on the established evidence base for traditional brief interventions , interventions using the Internet as a mode of delivery are being developed .\
BACKGROUND	Published evidence of replication of initial findings and ongoing development and modification of Web-based personalized feedback interventions for student alcohol use is relatively rare .\
BACKGROUND	The current paper reports on the replication of the initial Unitcheck feasibility trial .\
OBJECTIVE	To evaluate the effectiveness of Unitcheck , a Web-based intervention that provides instant personalized feedback on alcohol consumption .\
OBJECTIVE	It was hypothesized that use of Unitcheck would be associated with a reduction in alcohol consumption .\
METHODS	A randomized control trial with two arms ( control = assessment only ; intervention = fully automated personalized feedback delivered using a Web-based intervention ) .\
METHODS	The intervention was available week 1 through to week 15 .\
METHODS	Students at a UK university who were completing a university-wide annual student union electronic survey were invited to participate in the current study .\
METHODS	Participants ( n = 1618 ) were stratified by sex , age group , year of study , self-reported alcohol consumption , then randomly assigned to one of the two arms , and invited to participate in the current trial .\
METHODS	Participants were not blind to allocation .\
METHODS	In total , n = 1478 ( n = 723 intervention , n = 755 control ) participants accepted the invitation .\
METHODS	Of these , 70 % were female , the age ranged from 17-50 years old , and 88 % were white/white British .\
METHODS	Data were collected electronically via two websites : one for each treatment arm .\
METHODS	Participants completed assessments at weeks 1 , 16 , and 34 .\
METHODS	Assessment included CAGE , a 7-day retrospective drinking diary , and drinks consumed per drinking occasion .\
RESULTS	The regression model predicted a monitoring effect , with participants who completed assessments reducing alcohol consumption over the final week .\
RESULTS	Further reductions were predicted for those allocated to receive the intervention , and additional reductions were predicted as the number of visits to the intervention website increased .\
CONCLUSIONS	Unitcheck can reduce the amount of alcohol consumed , and the reduction can be sustained in the medium term ( ie , 19 weeks after intervention was withdrawn ) .\
CONCLUSIONS	The findings suggest self-monitoring is an active ingredient to Web-based personalized feedback .\
\
###14983420\
OBJECTIVE	The urethral retro-resistance pressure ( URP ) is a retrograde urethral pressure profile measured by a new urodynamic measurement system .1 GYNECARE MoniTorr Urodynamic Measurement System ( ETHICON , Inc. , Somerville , NJ ) .\
OBJECTIVE	URP is the pressure required to achieve and maintain an open sphincter .\
OBJECTIVE	This clinical investigation focused on a comparison of URP to standard urodynamic measurements and an examination of their relationship to incontinence severity .\
METHODS	Twenty-two centers enrolled 258 stress incontinent women in a randomized , crossover study of two groups : ( 1 ) test procedure followed by multichannel urodynamics , ( 2 ) multichannel urodynamics followed by test procedure .\
METHODS	We defined incontinence severity categories using 24 hr urine loss and assessed these categories using incontinence quality of life ( I-QOL ) , urinary incontinence severity score ( UISS ) , incontinence visual analogue score ( VAS ) , URP , maximum urethral closure pressure ( MUCP ) , and leak point pressure ( LPP ) .\
RESULTS	The mean age was 56.2 ( + / -12 ) years .\
RESULTS	No order effect was present .\
RESULTS	The correlation coefficient between URP and MUCP was 0.31 ( 95 % CI 0.19-1 , P < 0.0001 ) ; between URP and LPP was 0.28 ( 95 % CI 0.12-1 , P = 0.003 ) ; and between MUCP and LPP was 0.14 ( 95 % CI-0 .04 -1 , P = 0.101 ) .\
RESULTS	The mean values for URP across symptom severity categories were significantly different ( P = 0.028 ) and decreased with increasing severity .\
RESULTS	The mean values for MUCP and LPP did not decrease with increasing severity .\
CONCLUSIONS	The study demonstrated that URP had a consistent relationship with incontinence severity .\
CONCLUSIONS	The data suggested that URP is a physiological measure of urethral function and may have clinical utility as a diagnostic tool .\
CONCLUSIONS	Future outcomes-based research is necessary to establish the predictive value of URP , MUCP , and LPP measurements in terms of incontinence cure rates and diagnosis of sphincter dysfunction .\
\
###23705963\
BACKGROUND	Distressed individuals in Korea may benefit from the practice of mind-body exercises such as Qigong .\
BACKGROUND	However , the effectiveness of such techniques needs to be investigated .\
METHODS	Fifty participants who were eligible to this study were randomized into a group receiving a 4-week intervention of a brief Qigong-based stress reduction program ( BQSRP ) or a wait-list control group .\
METHODS	Before and after the intervention period , saliva samples were collected and questionnaires were completed on perceived stress , anxiety , `` Hwa-Byung '' ( anger syndrome ) , and quality of life .\
METHODS	Salivary cortisol has emerged in mind-body therapy research as an easy-to-collect , relatively inexpensive , biologic marker of stress .\
METHODS	Salivary corisol were collected to evaluate physiological effect of BQSRP .\
METHODS	Between-group comparisons of change from baseline to study completion were analyzed by analysis of covariance for the Perceived Stress Scale and independent two sample t-tests for other measures .\
RESULTS	Compared with the control group , the BQSRP intervention group displayed significantly larger decreases in Perceived Stress Scale scores ( p = 0.0006 ) , State Anxiety scores ( p = 0.0028 ) , Trait Anxiety scores ( p < 0.0001 ) , personality subscale scores of the Hwa-Byung Scale ( p = 0.0321 ) , symptoms scores of the Hwa-Byung Scale ( p = 0.0196 ) , and a significantly larger increase in World Health Organization Quality of Life Abbreviated version scores ( ps < .05 ) .\
RESULTS	Salivary cortisol levels were not changed .\
CONCLUSIONS	The BQSRP appears to be effective in reducing stress perception , anxiety , anger , and improving quality of life ( KCT0000056 ) .\
\
###22161845\
BACKGROUND	Perampanel is a selective , noncompetitive - amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid receptor antagonist .\
BACKGROUND	Two multicenter randomized , double-blind , placebo-controlled , parallel-group phase III studies assessed the efficacy and safety of adjunctive perampanel in patients with Parkinson 's disease and motor fluctuations .\
METHODS	In both phase III studies ( 301 and 302 ) , levodopa-treated patients were randomized and treated with once-daily oral placebo ( n = 504 ) , perampanel 2 mg ( n = 509 ) , or perampanel 4 mg ( n = 501 ) .\
METHODS	The primary end point was change in daily `` off '' time from baseline .\
METHODS	The treatment period was 30 weeks in study 301 and 20 weeks in study 302 .\
RESULTS	For any efficacy end point , perampanel 2 or 4 mg was not superior to placebo .\
RESULTS	Perampanel was well tolerated up to 4 mg/day .\
CONCLUSIONS	Perampanel failed to significantly improve motor symptoms versus placebo .\
CONCLUSIONS	There was also no effect on the duration or disability of levodopa-induced dyskinesia .\
\
###23475700\
BACKGROUND	The presence of asymptomatic left ventricular diastolic dysfunction ( LVDD ) in hypertensive patients can be associated with the development of cardiac events .\
BACKGROUND	The increase in sympathetic activity may be 1 of the mechanisms that predisposes to this outcome .\
BACKGROUND	In this study , we analyzed 2 hypotheses : ( i ) whether sympathetic activity is higher in the presence of LVDD , independent of blood pressure control and ( ii ) whether different classes of LVDD have a different effect on sympathetic activity .\
METHODS	After analyzing left ventricular function using echo Doppler cardiography , 45 hypertensive patients receiving treatment were allocated into 3 groups : normal function ( LV-NF , n = 15 ) , impaired relaxation ( LV-IR , n = 15 ) , and pseudonormal or restrictive ( LV-P/R , n = 15 ) .\
METHODS	An age - , sex - , and body mass index-matched control group of normotensive volunteers ( N , n = 14 ) was included .\
METHODS	Muscle sympathetic nerve activity ( MSNA ) , heart rate , and systolic blood pressure variabilities and baroreflex sensitivity were evaluated while the patient was in a supine position .\
RESULTS	Blood pressure and antihypertensive drug use were similar among the hypertensive groups .\
RESULTS	The LV-IR and LV-P/R groups had similar MSNA ( 331 and 321 bursts/min , respectively ) , which was significantly higher than that of the LV-NF and N groups ( 263 and 152 bursts/min , respectively ) .\
RESULTS	The LV-IR and LV-P/R groups had significantly higher LF-systolic blood pressure variability and significantly lower baroreflex sensitivity compared with the N group .\
CONCLUSIONS	The presence of asymptomatic LVDD is associated with increased MSNA , independent of blood pressure control .\
CONCLUSIONS	The sympathetic hyperactivity associated with LVDD is similar in the different patterns of LVDD studied .\
\
###11176469\
OBJECTIVE	Ureteral access sheaths were initially developed to facilitate difficult ureteroscopic access .\
OBJECTIVE	However , to our knowledge no formal evaluations have been performed to assess the routine use of ureteral access sheaths .\
OBJECTIVE	Therefore , we prospectively analyzed intraoperative time , symptomatic outcome , major complications , stone-free rate and overall costs related to the routine use of a new ureteral access sheath during standard ureteroscopic procedures .\
METHODS	Patients undergoing 6.5 Fr semirigid or 7.5 Fr flexible ureteroscopy were prospectively randomized to unaided ureteroscopy with no access sheath or ureteroscopy via a 12-14Fr ureteral access sheath .\
METHODS	Patients who required ureteral dilatation were randomized to the ureteral access sheath used as a dilator or a standard 18Fr ureteral balloon dilator .\
METHODS	Patients were evaluated postoperatively on days 0 , 1 and 6 with a questionnaire to assess pain , irritative symptoms and complications .\
METHODS	The stone-free rate and long-term complications were determined by excretory urography or computerized tomography at 3 months .\
RESULTS	Enrolled in the study were 59 consecutive patients , who underwent a total of 62 ureteroscopic procedures .\
RESULTS	Of the 47 patients ( 76 % ) who did not require ureteral dilatation 23 ( 49 % ) underwent ureteroscopy via the ureteral access sheath and 24 ( 51 % ) underwent unaided ureteroscopy .\
RESULTS	Seven of the 15 patients ( 28 % ) who required ureteral dilatation underwent access sheath dilatation , while balloon dilatation was performed in 8 .\
RESULTS	There was no significant difference in postoperative symptoms , complication rate or stone-free status in the access sheath and nonaccess sheath groups in patients not requiring ureteral dilatation ( p < 0.05 ) .\
RESULTS	A significant increase in postoperative symptoms was noted when the balloon was used as a dilator compared to the access sheath .\
RESULTS	Operative time and costs in all patients who underwent access sheath dilatation were less than in those in whom the access sheath was not used .\
RESULTS	In the 15 patients who required dilatation 71 % of access sheath and 100 % of balloon dilatations were successful .\
CONCLUSIONS	Routine use of a ureteral access sheath appears to facilitate semirigid and flexible ureteroscopy by decreasing operative time and costs , allowing direct visualization of ureteroscope insertion with simple ureteral re-entry and assisting renal and ureteral access with minimal associated morbidity .\
CONCLUSIONS	A ureteral access sheath should be considered for routine ureteroscopic procedures .\
\
###21178591\
OBJECTIVE	This study examined predictors of treatment expectation among osteoarthritis ( OA ) patients in a multisite clinical trial of pain coping skills training ( CST ) .\
METHODS	Patients ( N = 171 ) completed a pretreatment assessment battery that asked questions about treatment expectations , pain coping variables , pain , physical function , psychological distress , quality of life , and depression as well as background demographic and medical variables .\
RESULTS	Regression analyses indicated that several variables accounted for 21 % of the variance in treatment expectations ( P < 0.0001 ) .\
RESULTS	Patients who were classified as adaptive copers , reported higher self-efficacy and social interaction , had higher quality of life , and who had lower levels of affective distress and depression had more positive expectations about engaging in pain CST .\
RESULTS	Variables that were not associated with treatment expectation were level of pain and physical dysfunction , duration of disease , and disability status as well as demographic variables .\
CONCLUSIONS	Although many OA patients will approach pain CST with positive expectations , others have lower expectations .\
CONCLUSIONS	This study suggests that a multidimensional assessment of OA patients with chronic pain can identify those who have higher expectations versus lower expectations .\
CONCLUSIONS	The results suggest that patients who are psychologically distressed are less optimistic about engaging in treatment and that these patients , in particular , may benefit from and need pretreatment motivational interviewing to enhance their uptake of pain coping skills .\
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###25742320\
OBJECTIVE	To assess whether customised mobile phone reminders would improve adherence to therapy and thus decrease virological failure among HIV infected patients starting antiretroviral treatment ( ART ) .\
METHODS	Randomised controlled trial among HIV infected patients initiating antiretroviral treatment .\
METHODS	Three diverse healthcare delivery settings in south India : two ambulatory clinics within the Indian national programme and one private HIV healthcare clinic .\
METHODS	631 HIV infected , ART nave , adult patients eligible to initiate first line ART were randomly assigned to mobile phone intervention ( n = 315 ) or standard care ( n = 316 ) and followed for 96 weeks .\
METHODS	The intervention consisted of customised , interactive , automated voice reminders , and a pictorial message that were sent weekly to the patients ' mobile phones for the duration of the study .\
METHODS	The primary outcome was time to virological failure ( viral load > 400 copies/mL on two consecutive measurements ) .\
METHODS	Secondary outcomes included ART adherence measured by pill count , death rate , and attrition rate .\
METHODS	Suboptimal adherence was defined as mean adherence < 95 % .\
RESULTS	Using an intention-to-treat approach we found no observed difference in time to virological failure between the allocation groups : failures in the intervention and standard care arms were 49/315 ( 15.6 % ) and 49/316 ( 15.5 % ) respectively ( unadjusted hazard ratio 0.98 , 95 % confidence interval 0.67 to 1.47 , P = 0.95 ) .\
RESULTS	The rate of virological failure in the intervention and standard care groups were 10.52 and 10.73 per 100 person years respectively .\
RESULTS	Comparison of suboptimal adherence was similar between both groups ( unadjusted incidence rate ratio 1.24 , 95 % CI 0.93 to 1.65 , P = 0.14 ) .\
RESULTS	Incidence proportion of patients with suboptimal adherence was 81/300 ( 27.0 % ) in the intervention arm and 65/299 ( 21.7 % ) in the standard care arm .\
RESULTS	The results of analyses adjusted for potential confounders were similar , indicating no significant difference between the allocation groups .\
RESULTS	Other secondary outcomes such as death and attrition rates , and subgroup analysis also showed comparable results across allocation groups .\
CONCLUSIONS	In this multicentre randomised controlled trial among ART nave patients initiating first line ART within the Indian national programme , we found no significant effect of the mobile phone intervention on either time to virological failure or ART adherence at the end of two years of therapy.Trial registration Current Controlled Trials ISRCTN79261738 .\
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###8730607\
OBJECTIVE	Dietary fat intake is higher than recommended in most western countries and is associated with the prevalence of cardiovascular diseases , obesity and cancer .\
OBJECTIVE	The growing public concern about the adverse effects of a high fat intake has led to an increased availability of reduced-fat ' products .\
OBJECTIVE	Consumption of reduced-fat products might be a convenient way to reduce the energy intake .\
OBJECTIVE	Besides the potential of reduced-fat products to reduce the energy intake , it might change dietary fat intake , both qualitatively and quantitatively , which in turn might also affect oxidative stress , i.e. the anti-oxidant/pro-oxidant ratio .\
OBJECTIVE	In this paper we present the effects of 6-month consumption of reduced-fat products on body weight , energy , macronutrient and vitamin E intake , concentration of the plasma lipid peroxidation product malondialdehyde ( MDA ) , erythrocyte free radical scavenging enzymes activities ( glutathione peroxidase activity ( GSH-Px ) ; superoxide dismutase ( SOD ) and catalase ) as well as plasma fat-soluble anti-oxidative vitamin concentrations ( beta-carotene , lycopene and alpha-tocopherol ) .\
METHODS	A randomized semi-controlled parallel comparison trial of six months , preceded by a one-month adaptation period .\
METHODS	The reduced-fat and full fat products were provided through a realistic shop in order to mimic a free-living ' situation .\
METHODS	Subjects were recruited from respondents on advertisements .\
METHODS	Eighty healthy , normal weight ( BMI : range 20-30 kg/m2 ) subjects , aged between 20 and 55y , were selected to participate in this study ; 76 subjects completed the study .\
METHODS	6 months consumption of either reduced-fat or full-fat products .\
RESULTS	During the intervention period , consumption of reduced fat products resulted in significantly lower energy intake , in a lower percentage of energy derived from saturated fatty acids , monounsaturated fatty acids and polyunsaturated fatty acids as well as in lower vitamin E intake , when compared to the control group .\
RESULTS	Body weight , the ratio polyunsaturated fatty acids/saturated fatty acids , plasma MDA , vitamin concentrations ( beta-carotene , lycopene and alpha-tocopherol ) , and erythrocyte free radical scavenging enzyme activities ( SOD , GSH-Px and catalase ) were not affected by the intervention .\
CONCLUSIONS	Neither the difference in energy intake , nor the change in dietary fat composition seems to affect the integrity of the antioxidant scavenging capacity , assessed by measuring plasma MDA and antioxidative vitamins ( lycopene , beta-carotene and alpha-tocopherol ) and erythrocyte free radical scavenging enzymes ( SOD , GSH-Px and catalase ) .\
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###23067272\
BACKGROUND	Missing outcome data are very common in smoking cessation trials .\
BACKGROUND	It is often assumed that all such missing data are from participants who have been unsuccessful in giving up smoking ( `` missing = smoking '' ) .\
BACKGROUND	Here we use data from a recent Internet based smoking cessation trial in order to investigate which of a set of a priori chosen baseline variables are predictive of missingness , and the evidence for and against the `` missing = smoking '' assumption .\
METHODS	We use a selection model , which models the probability that the outcome is observed given the outcome and other variables .\
METHODS	The selection model includes a parameter for which zero indicates that the data are Missing at Random ( MAR ) and large values indicate `` missing = smoking '' .\
METHODS	We examine the evidence for the predictive power of baseline variables in the context of a sensitivity analysis .\
METHODS	We use data on the number and type of attempts made to obtain outcome data in order to estimate the association between smoking status and the missing data indicator .\
RESULTS	We apply our methods to the iQuit smoking cessation trial data .\
RESULTS	From the sensitivity analysis , we obtain strong evidence that older participants are more likely to provide outcome data .\
RESULTS	The model for the number and type of attempts to obtain outcome data confirms that age is a good predictor of missing data .\
RESULTS	There is weak evidence from this model that participants who have successfully given up smoking are more likely to provide outcome data but this evidence does not support the `` missing = smoking '' assumption .\
RESULTS	The probability that participants with missing outcome data are not smoking at the end of the trial is estimated to be between 0.14 and 0.19 .\
CONCLUSIONS	Those conducting smoking cessation trials , and wishing to perform an analysis that assumes the data are MAR , should collect and incorporate baseline variables into their models that are thought to be good predictors of missing data in order to make this assumption more plausible .\
CONCLUSIONS	However they should also consider the possibility of Missing Not at Random ( MNAR ) models that make or allow for less extreme assumptions than `` missing = smoking '' .\
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###18510659\
OBJECTIVE	To evaluate the efficacy of tolterodine extended-release ( ER ) plus tamsulosin on lower urinary tract symptoms ( LUTS ) as assessed by changes in the International Prostate Symptom Score ( IPSS ) in men who met symptom entry criteria for both overactive bladder ( OAB ) and benign prostatic hyperplasia ( BPH ) trials .\
METHODS	Men aged > or = 40 years with an IPSS of > or = 12 and diary-documented OAB symptoms ( > or = 8 voids/24 h and > or = 3 urgency episodes/24 h , with or without urgency urinary incontinence ) who reported at least moderate problems related to their bladder condition were randomized to receive placebo , tolterodine ER ( 4 mg ) , tamsulosin ( 0.4 mg ) , or tolterodine ER ( 4 mg ) + tamsulosin ( 0.4 mg ) once daily for 12 weeks .\
METHODS	Patients completed the IPSS at baseline and at 1 , 6 and 12 weeks .\
RESULTS	Patients receiving tolterodine ER + tamsulosin had significantly greater improvements than those taking placebo on IPSS storage subscale scores and scores for all three individual storage items included on the IPSS ( urinary frequency , urgency , and nocturnal micturitions ) by 12 weeks .\
RESULTS	Storage subscale and urgency scores were significantly improved vs placebo at 1 and 6 weeks , whereas frequency scores were significantly improved at 6 weeks .\
RESULTS	Changes in IPSS storage subscale and individual storage item scores in the tolterodine ER and tamsulosin monotherapy groups were not significantly different from placebo at most time points .\
RESULTS	IPSS voiding subscale scores and scores for three of four individual voiding items ( sensation of incomplete emptying , intermittency , and weak stream ) were significantly improved by 12 weeks for patients receiving tamsulosin monotherapy vs placebo .\
RESULTS	Voiding subscale and intermittency scores were significantly improved vs placebo at 1 week ; weak stream scores were significantly improved at 1 and 6 weeks .\
RESULTS	The IPSS voiding subscale and individual voiding item scores in the tolterodine ER + tamsulosin and tolterodine ER groups were not significantly different from placebo at most time points .\
CONCLUSIONS	In this distinct clinical research population of men who met traditional symptom entry criteria for both OAB and BPH trials , tolterodine ER + tamsulosin was significantly more effective than placebo in treating storage LUTS , including OAB symptoms .\
CONCLUSIONS	Tamsulosin monotherapy produced significant improvements in voiding LUTS .\
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###21241447\
OBJECTIVE	To investigate the effects of laughter therapy on depression , cognitive function , quality of life , and sleep of the elderly in a community .\
METHODS	Between July and September 2007 , the total study sample consisted of 109 subjects aged over 65 divided into two groups ; 48 subjects in the laughter therapy group and 61 subjects in the control group .\
METHODS	The subjects in the laughter therapy group underwent laughter therapy four times over 1 month .\
METHODS	We compared Geriatric Depression Scale ( GDS ) , Mini-Mental State Examination ( MMSE ) , Short-Form Health Survey-36 ( SF-36 ) , Insomnia Severity Index ( ISI ) and Pittsburgh Sleep Quality Index ( PSQI ) between the two groups before and after laughter therapy .\
RESULTS	There were no significant differences in baseline characteristics between the two groups .\
RESULTS	Before laughter therapy , the GDS scores were 7.98 3.58 and 8.08 3.96 ; the MMSE scores were 23.81 3.90 and 22.74 4.00 ; total scores of SF-36 were 54.77 17.63 and 52.54 21.31 ; the ISI scores were 8.00 6.29 and 8.36 6.38 ; the PSQI scores were 6.98 3.41 and 7.38 3.70 in laughter therapy group and control groups , respectively .\
RESULTS	After laughter therapy , the GDS scores were 6.94 3.19 ( P = 0.027 ) and 8.43 3.44 ( P = 0.422 ) ; the MMSE scores were 24.63 3.53 ( P = 0.168 ) and 23.70 3.85 ( P = 0.068 ) ; total scores of SF-36 were 52.24 17.63 ( P = 0.347 ) and 50.32 19.66 ( P = 0.392 ) ; the ISI scores were 7.58 5.38 ( P = 0.327 ) and 9.31 6.35 ( P = 0.019 ) ; the PSQI scores were 6.04 2.35 ( P = 0.019 ) and 7.30 3.74 ( P = 0.847 ) in both groups , respectively .\
CONCLUSIONS	Laughter therapy is considered to be useful , cost-effective and easily-accessible intervention that has positive effects on depression , insomnia , and sleep quality in the elderly .\
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###22031509\
BACKGROUND	Heightened cardiovascular responses to mental stressors are associated with future risk of hypertension .\
BACKGROUND	The role of cortisol , a key stress hormone produced by the hypothalamic-pituitary-adrenal axis , remains unclear .\
OBJECTIVE	Our objective was to examine the association between cortisol responses to laboratory-induced mental stress and incident hypertension .\
METHODS	This was a prospective substudy of the Whitehall II cohort with 3 years follow-up of an occupational cohort .\
METHODS	Participants included 479 initially healthy men and women ( mean age , 62.7 5.6 yr ) , without history or objective signs of cardiovascular disease or hypertension at study entry .\
METHODS	At the baseline assessment , salivary cortisol was measured in response to mental stressors , consisting of a 5-min Stroop task and a 5-min mirror tracing task .\
METHODS	Blood pressure was measured at study entry and at 3 yr follow-up for the determination of hypertension .\
RESULTS	There was considerable variation in the cortisol stress response , with approximately 40 % of the sample responding to the stress tasks with an increase in cortisol of at least 1 mmol/liter .\
RESULTS	Over the 3 yr follow-up , 15.9 % of the sample developed hypertension .\
RESULTS	There was an association between cortisol stress reactivity ( per sd ) and incident hypertension ( odds ratio = 1.59 ; 95 % confidence interval = 1.17-2 .17 ) after adjustments for age , sex , resting cortisol , blood pressure at study entry , employment grade , smoking , body mass index , glycated hemoglobin , use of statins , and blood lipids .\
CONCLUSIONS	These data support the notion that cortisol reactivity , an index of hypothalamic-pituitary-adrenal function , is one of the possible mechanisms through which psychosocial stress may influence the risk of hypertension .\
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###19281446\
BACKGROUND	The Randomised Evaluation of Normal vs. Augmented Level of Replacement Therapy ( RENAL ) study is the largest interventional trial ever conducted in patients with acute renal failure .\
OBJECTIVE	To develop and report a pre-determined statistical analysis plan which the investigators will adhere to in analysing the data from the trial .\
METHODS	The data collected by the researchers as part of the trial protocol was reviewed and formally assessed .\
METHODS	Information relevant to baseline characteristics was selected and , for each item , statistically relevant descriptive elements were described .\
METHODS	Information relevant to the process of care and delivery of prescribed trial therapy was similarly classified and , for each item , appropriate descriptive statistical analysis was planned with appropriate comparison between groups .\
METHODS	Finally , trial outcomes were selected , and an appropriate statistical comparison between groups was planned and described .\
RESULTS	A standard analysis plan for the RENAL trial results was developed , which allows a comprehensive description of baseline characteristics , features of the process of care and trial treatment delivery , and pre-determined statistical assessment of relevant outcome measures in a way that is transparent , available to the public , verifiable and predetermined before the actual analysis of data .\
CONCLUSIONS	We have developed a pre-determined statistical analysis plan for the RENAL trial .\
CONCLUSIONS	This plan will be adhered to in order to avoid introducing any analysis bias associated with prior knowledge of study findings .\
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###15474698\
OBJECTIVE	In patients with in-stent restenosis ( ISR ) several anatomic subgroups have been identified .\
OBJECTIVE	ISR affecting the stent edge ( EDG ) is a poorly characterised subgroup with undefined therapeutic implications .\
OBJECTIVE	We sought to determine the implications of ISR affecting the stent EDG .\
RESULTS	450 patients included in the `` Restenosis Intra-stent : Balloon angioplasty vs elective Stenting '' ( RIBS ) randomized study , were analysed .\
RESULTS	EDG ISR was predefined in the protocol and the pattern of ISR analysed in a centralized core-lab .\
RESULTS	Fifty-two patients ( 12 % ) had EDG ISR ( 29 stent group , 23 balloon arm ) .\
RESULTS	Patients with EDG ISR had less severe [ minimal lumen diameter ( MLD ) ( 0.78 + / -0.3 vs 0.66 + / -0.3 mm , p = 0.05 ) ] and shorter lesions ( lesion length 10.2 + / -6 vs 13.2 + / -7 mm , p = 0.003 ) .\
RESULTS	Patients with EDG ISR more frequently required crossover ( 12 % vs 3 % , p = 0.006 ) but eventually the immediate angiographic result and the long-term clinical and angiographic outcome was similar to that found in patients without EDG ISR .\
RESULTS	Patients with EDG ISR treated in the balloon and stent arms had similar baseline characteristics .\
RESULTS	However , after intervention , the immediate angiographic result was better in the stent arm ( MLD 2.79 + / -0.4 vs 2.35 + / -0.3 mm , p = 0.001 ) .\
RESULTS	This difference persisted at late follow-up : MLD ( 1.93 + / -0.7 vs 1.39 + / -0.7 mm , p = 0.01 ) , recurrent restenosis ( 20 % vs 50 % , p = 0.03 ) .\
RESULTS	In addition , the 1-year event-free survival was significantly better ( 83 % vs 52 % , log rank p = 0.01 ; Cox HR 0.28 , 95 % CI 0.09-0 .79 ) in the stent arm .\
RESULTS	Moreover , stent implantation was an independent predictor of freedom from target vessel revascularization ( HR 0.15 , 95 % CI 0.03-0 .67 , p = 0.003 ) .\
CONCLUSIONS	EDG ISR constitutes a specific subgroup with relevant therapeutic implications .\
CONCLUSIONS	In patients with EDG ISR , repeat stent implantation provides better clinical and angiographic outcome than conventional balloon angioplasty .\
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###8547556\
OBJECTIVE	This study was designed to evaluate whether a continuous low-dose lidocaine infusion reduces postoperative pain and anxiety in patients undergoing coronary artery bypass grafting ( CABG ) and to retrospectively examine time to extubation , intensive care unit stay ( ICU ) , and hospital length of stay .\
METHODS	A double-blinded , randomized , and prospective approach .\
METHODS	Hospital patients undergoing first-time CABG .\
METHODS	After informed consent , 100 patients were enrolled in this study .\
METHODS	Lidocaine infusion or placebo substitute was begun after induction of anesthesia .\
METHODS	The fentanyl/midazolam infusion was discontinued on ICU admission ; lidocaine or placebo continued until ICU discharge .\
METHODS	Supplemental fentanyl , midazolam , or propranolol was administered for pain , anxiety , or hemodynamic stress .\
RESULTS	Drug dosages were compared between groups .\
RESULTS	Postoperative assessment included visual analog pain score , hemodynamics , sedation score , and nursing assessment .\
RESULTS	Mean total dosages of fentanyl , midazolam , and propranolol between the lidocaine and placebo groups were 620.40 + / - 815.74 microgram versus 689.16 + / - 692.99 microgram , p = 0.244 ; 0.54 + / - 1.13 mg versus 1.20 + / - 2.44 mg p = 0.465 ; 0.11 + / - 0.75 mg versus 3.56 + / - 17.2 mg , p = 0.564 , respectively .\
RESULTS	Times to extubation , ICU length of stay , and hospital stay did not achieve statistical significance .\
CONCLUSIONS	Continuous infusion of low-dose lidocaine did not significantly decrease supplemental fentanyl , midazolam , or propranolol requirement postoperatively .\
CONCLUSIONS	Similarly , a lidocaine infusion does not result in reduced time to extubation .\
CONCLUSIONS	ICU stay , or hospital length of stay .\
\
###23208837\
BACKGROUND	The International Breast Cancer Study Group conducted a phase III trial in Australian/New Zealand ( ANZ ) and Swiss/German/Austrian ( SGA ) centres on training doctors in clear and ethical information delivery about treatment options and strategies to encourage shared decision making .\
METHODS	Medical , surgical , gynaecological and radiation oncologists , and their patients for whom adjuvant breast cancer therapy was indicated , were eligible .\
METHODS	Doctors were randomised to participate in a workshop with standardised teaching material and role playing .\
METHODS	Patients were recruited in the experimental and control groups before and after the workshop .\
RESULTS	In ANZ centres , 21 eligible doctors recruited a total of 304 assessable patients .\
RESULTS	In SGA centres , 41 doctors recruited 390 patients .\
RESULTS	The training was well accepted .\
RESULTS	There was no overall effect on patient decisional conflict ( primary endpoint ) 2weeks after the consultation .\
RESULTS	Overall , patients were satisfied with their treatment decision , their consultation and their doctors ' consultation skills .\
RESULTS	Considerable variation was observed in patient outcomes between SGA and ANZ centres ; the effect sizes of the intervention were marginal ( < 0.2 ) .\
CONCLUSIONS	Shared decision making remains a challenge .\
CONCLUSIONS	A sustained training effect may require more intensive training tailored to the local setting .\
CONCLUSIONS	Cross-cultural differences need attention in conducting trials on communication interventions .\
\
###23489112\
OBJECTIVE	To determine the amniotic fluid CD200 levels in uncomplicated pregnancies and in preterm prelabor rupture of the membranes ( PPROM ) according to microbial invasion of the amniotic cavity and histological chorioamnionitis and its association with neonatal outcomes .\
METHODS	One hundred and fifty-nine women with singleton pregnancies were included in this study .\
METHODS	Amniotic fluid was collected , and CD200 levels were determined using ELISA .\
RESULTS	No difference was found in CD200 levels between women in the second trimester and women at term without labor .\
RESULTS	Women at term with labor had higher CD200 levels than women in the second trimester and women at term without labor .\
RESULTS	The presence of funisitis in PPROM pregnancies was associated with higher CD200 levels independent of gestational age ( with funisitis : median 197.5 pg/mL versus without funisitis : median 61.0 pg/mL ; p = 0.003 ) .\
RESULTS	The need for tracheal intubation and the development of bronchopulmonary dysplasia were associated with higher CD200 levels .\
CONCLUSIONS	Amniotic fluid CD200 levels remained stable in advanced pregnancy and they were increased during parturition .\
CONCLUSIONS	Elevated CD200 levels in the presence of funisitis suggest the involvement of negative regulatory mechanisms of innate immunity .\
CONCLUSIONS	CD200 may play a role in the development of pulmonary aspects of neonatal morbidity .\
\
###20948453\
BACKGROUND	Neisseria meningitidis serogroups B , C , and Y cause most meningococcal disease in industrialized countries .\
BACKGROUND	A Haemophilus influenzae type b-meningococcal serogroups C and Y-tetanus toxoid conjugate vaccine ( HibMenCY-TT ) was evaluated .\
METHODS	A total of 1104 infants ( randomized 3:1:1 ) were vaccinated at 2 , 4 , and 6 months with HibMenCY-TT , MenC-CRM197 + Hib-TT , or Hib-TT .\
METHODS	At 12 to 15 months , HibMenCY-TT and MenC-CRM-primed children received HibMenCY-TT ; Hib-TT-primed received N. meningitidis serogroup B Hib-outer membrane protein complex .\
METHODS	Antibody concentrations and rabbit/human complement serum bactericidal antibody titers ( rSBA/hSBA ) were determined .\
METHODS	Safety was monitored after each dose ( diary cards for first 31 days ) until 6 months postdose 4 .\
RESULTS	Postdose 3 , rates of antipolyribosylribitol phosphate 1 g/mL and rSBA-MenC 1:128 in HibMenCY-TT recipients were noninferior to licensed controls .\
RESULTS	Percentages reaching 0.15 g/mL ( 1.0 g/mL postdose 3 ) and antipolyribosylribitol phosphate GMC were significantly higher after HibMenCY-TT than Hib-TT postdose 2 and postdose 3 .\
RESULTS	The GMC remained significantly higher before and after dose 4 .\
RESULTS	Proportions of HibMenCY-TT recipients with rSBA 1:8 were 95.6 % ( MenC ) , 98.6 % ( MenY ) postdose-2 , 99 % for MenC/Y postdose 3 and 4 ; hSBA 1:4 were 95.5 % ( MenC ) , 89.8 % ( MenY ) postdose 2 , > 97 % for MenC/Y postdose 3 and 4 .\
RESULTS	HibMenCY-TT had a similar safety profile to control vaccines .\
CONCLUSIONS	HibMenCY-TT induced noninferior Hib and MenC responses compared with monovalent Hib and MenC conjugates with a comparable safety profile .\
CONCLUSIONS	Bactericidal antibodies against MenC/Y were induced after 2 doses of HibMenCY-TT .\
\
###23727422\
BACKGROUND	Hemodialysis patients are at increased risk of hepatitis B virus ( HBV ) infection and patients with chronic kidney disease ( CKD ) are commonly hyporesponsive to HBV vaccines .\
BACKGROUND	Current recommendations for CKD patients are to utilize 4 double-doses ( 220 mcg HBsAg ) of a licensed hepatitis B vaccine ( HBsAg-Eng ) .\
METHODS	An observer-blind , randomized , active-controlled , parallel group , multicenter trial was conducted among 521 patients 18-75 years of age with CKD , comparing 3 single doses of an investigational hepatitis B vaccine ( 20 mcg rHBsAg +3000 mcg 1018 , a toll-like receptor 9 agonist ) given at 0 , 4 , and 24 weeks to 4 double-doses of HBsAg-Eng ( 220 mcg rHBsAg +500 mcg alum ) given at 0 , 4 , 8 , and 24 weeks ( total of 8 injections ) .\
METHODS	Participants were followed for 1 year .\
RESULTS	Among 467 participants in the modified intent-to-treat population , at the primary endpoint at week 28 , the seroprotection rate ( SPR : % with anti-HBs10mIU / mL ) in the HBsAg-1018 group ( 89.9 % ) met criteria for noninferiority and superiority to the SPR in the HBsAg-Eng group ( 81.8 % ) .\
RESULTS	At week 28 , the percentage of participants with anti-HBs100mIU / mL in the HBsAg-1018 group ( 73.6 % ) was significantly higher than in the HBsAg-Eng group ( 63.2 % ) .\
RESULTS	In addition , the geometric mean concentration of anti-HBs in the HBsAg-1018 group ( 587.1 mIU/mL ) was significantly higher than in the HBsAg-Eng group ( 156.5 mIU/mL ) .\
RESULTS	At weeks 8 and 12 after the first study injection , SPRs in the HBsAg-1018 group were significantly higher than in the HBsAg-Eng group .\
RESULTS	At 52 weeks , the immune response to HBsAg-1018 remained higher than to HBsAg-Eng .\
RESULTS	HBsAg-1018 was generally well tolerated and had a similar safety profile to HBsAg-Eng .\
CONCLUSIONS	In CKD patients , 3 doses of HBsAg-1018 induced significantly higher seroprotection , earlier seroprotection , and more durable seroprotection than 4 double doses of HBsAg-Eng .\
\
###8598756\
BACKGROUND	Postnatal depression can have long-term adverse consequences for the mother , for the marital relationship , and for the infant 's psychological development .\
BACKGROUND	Such depressions can be severe and resistant to both support and counselling and to therapy with antidepressant drugs .\
BACKGROUND	We investigated the antidepressant efficacy of oestrogen given transdermally .\
METHODS	In a double-blind , placebo-controlled study , 61 women with major depression , which began within 3 months of childbirth and persisted for up to 18 months postnatally , were allocated randomly active treatment ( n = 34 ; 3 months of transdermal 17 beta-oestradiol 200 micrograms daily alone , then 3 months with added cyclical dydrogesterone 10mg daily for 12 days each month ) or placebo ( n = 27 ; placebo patches and tablets according to the same regimen ) .\
METHODS	The women were assessed monthly by self-ratings of depressive symptoms on the Edinburgh postnatal depression scale ( EPDS ) and by clinical psychiatric interview ( schedule for affective disorders and schizophrenia [ SADS ] - change scale ) .\
RESULTS	On pretreatment assessments the women in both groups were severely depressed ( mean EPDS score 21.8 [ SD 3.0 ] active group , 21.3 [ 2.9 ] placebo group ; SADS scores , 66.3 [ 11.4 ] and 64.3 [ 10.7 ] ) .\
RESULTS	During the first month of therapy the women receiving oestrogen improved rapidly , and to a significantly greater extent than controls ( mean EPDS scores 13.3 [ SD 5.7 ] vs 16.5 [ 5.3 ] .\
RESULTS	Patients receiving placebo also improved over time but , on average , their scores did not fall below the screening threshold for major depression for at least 4 months .\
RESULTS	The estimated overall treatment effect of oestrogen on the EPDS was 4.38 points ( 95 % Cl 1.89-6 .87 ) .\
RESULTS	None of a range of other factors ( age , psychiatric , obstetric and gynaecological history , severity and duration of current episode of depression , and concurrent antidepressant medication ) , influenced the response to oestrogen .\
CONCLUSIONS	This study has shown that transdermal oestrogen is an effective treatment for postnatal depression .\
CONCLUSIONS	Further studies are required to establish the minimum effective dose and shortest necessary duration of treatment as well as the mechanism of antidepressant action of oestrogen .\
\
###25398799\
BACKGROUND	Endotoxaemia is widely used as an experimental model to study sepsis under controlled conditions .\
BACKGROUND	Nighttime endotoxaemia induces a more pronounced inflammatory stress response compared to daytime .\
BACKGROUND	Previously , we have shown that melatonin has antioxidative and anti-inflammatory effects in inflammatory response to daytime endotoxaemia .\
BACKGROUND	Herein , we examined the effect of melatonin in response to human nighttime endotoxaemia .\
METHODS	Twelve healthy male volunteers were enrolled in a randomized , placebo-controlled , double-blinded cross-over trial .\
METHODS	Subjects were induced by lipopolysaccharide ( LPS ) endotoxin 0.3 ng/kg body weight intravenously at 24:00 .\
METHODS	One hour prior to induction of endotoxaemia , an 8-h infusion of melatonin 100 mg or placebo was initiated .\
METHODS	Blood samples were drawn before and 2 , 4 , 6 and 8 h after induction of endotoxaemia and plasma was tested for pro-inflammatory markers ( tumor necrosis factor alpha , TNF - , interleukin-1 , IL-1 , interleukin-1 , IL-6 , and YKL-40 ) , anti-inflammatory markers ( interleukin-1 receptor antagonist , IL-1Ra , interleukin-10 , IL-10 , soluble tumor necrosis factor receptors I and II , sTNF-RI and sTNF-RII ) , marker for oxidative damage ( malondialdehyde ( MDA ) ) and antioxidative enzyme ( ascorbic acid ( AA ) and dehydroascorbic acid ( DHA ) ) .\
RESULTS	Compared to placebo , melatonin did not reduce plasma levels of any of pro- and anti-inflammatory markers and it also failed to influence levels of AA , DHA and MDA .\
CONCLUSIONS	Melatonin has no beneficial effect on inflammation and oxidative damage induced by nighttime endotoxaemia in contrast to daytime endotoxaemia .\
\
###16221232\
BACKGROUND	Due to their impaired immune system , patients with renal insufficiency have a suboptimal response to hepatitis B ( HB ) vaccination and frequent boosters are needed to maintain protection .\
BACKGROUND	GlaxoSmithKline Biologicals has developed a HB vaccine containing a new adjuvant system AS04 for use in this immunocompromised patient population .\
METHODS	In an open , randomized clinical trial conducted in pre-hemodialysis ( documented creatinine clearance < or = 30 mL/min ) and hemodialysis patients , over 15 years of age and nave for HB , the immunogenicity and safety of single doses of HB-AS04 ( Fendrix , GlaxoSmithKline Biologicals ) were compared to double doses of commercially available HB vaccine ( Engerix , GlaxoSmithKline Biologicals ) administered at 0 , 1 , 2 , and 6 months , and followed-up for 36 months .\
RESULTS	The HB-AS04 vaccine elicited a more rapid onset of protection than the currently licensed vaccine for this particular population , with 74 % versus 52 % of subjects seroprotected at month 3 .\
RESULTS	After the vaccination course , seroprotection rates increased to 91 % versus 84 % in the HB-AS04 and standard vaccine groups , respectively .\
RESULTS	Differences persisted up to 36 months post-vaccination ( 73 % vs. 52 % , respectively ) .\
RESULTS	Antibody concentrations were higher following the HB-AS04 vaccine at all post-vaccination time points .\
RESULTS	During the follow-up , significantly fewer subjects primed with the HB-AS04 vaccine needed a booster dose as a consequence of anti-HBs loss below seroprotective levels ( 11/62 subjects in the HB-AS04 group vs. 22/57 subjects in the standard vaccine group , respectively , P = 0.014 ) .\
RESULTS	The HB-AS04 was more locally reactogenic than the standard immunization regimen , with pain at the injection site occurring with 41 % of HB-AS04 doses versus 19 % of standard vaccine doses .\
RESULTS	The occurrence of grade 3 pain was less than 1 % in both groups and all events resolved within the 4-day follow-up period .\
CONCLUSIONS	The improved immunogenicity profile and clinically acceptable reactogenicity of HB-AS04 vaccine are of key importance to provide a more rapid , enhanced , and longer seroprotection to these immunocompromised patients at risk for HB infection .\
\
###9489597\
OBJECTIVE	It has been suggested that provision of the substrate of nitric oxide ( NO ) synthesis , L-arginine , might influence the effects of renal vasoconstrictors .\
OBJECTIVE	We have therefore studied the effects of pretreatment or concomitant administration of L-arginine on angiotensin II ( ANG II ) - increased renovascular resistance .\
METHODS	The study was conducted in a double-blind , randomized , cross-over design .\
METHODS	Eight healthy subjects were assigned to placebo or a continuous intravenous coinfusion of ANG II ( 5.0 ng kg [ -1 ] min [ -1 ] , infusion period 75 min ) with L-arginine ( 17 mg kg [ -1 ] min [ -1 ] , infusion period 30 min ) .\
METHODS	Nine further subjects received a continuous infusion of ANG II with or without pretreatment of L-arginine .\
METHODS	Changes in renal plasma flow ( RPF ) were estimated by the steady state clearance of PAH .\
RESULTS	L-arginine alone increased RPF to 110 + / - 10 % over baseline ( P < 0.003 ) .\
RESULTS	The ANG II-induced decrease in RPF was not affected by pretreatment or coinfusion of L-arginine .\
CONCLUSIONS	Our results demonstrate that a counterregulatory response of the renal vasculature to high levels of ANG II does not depend on exogenous L-arginine .\
CONCLUSIONS	In healthy subjects , this lack of functional antagonism at the renal vasculature is therefore not a result of NO substrate availability .\
\
###25065337\
BACKGROUND	In previous studies , we identified two urinary proteomic classifiers , termed HF1 and HF2 , which discriminated subclinical diastolic left ventricular ( LV ) dysfunction from normal .\
BACKGROUND	HF1 and HF2 combine information from 85 and 671 urinary peptides , mainly up - or down-regulated collagen fragments .\
BACKGROUND	We sought to validate these classifiers in a population study .\
METHODS	In 745 people randomly recruited from a Flemish population ( 49.8 years ; 51.3 % women ) , we measured early and late diastolic peak velocities of mitral inflow ( E and A ) and mitral annular velocities ( e ' and a ' ) by conventional and tissue Doppler echocardiography , and the urinary proteome by capillary electrophoresis coupled with mass spectrometry .\
RESULTS	In the analyses adjusted for sex , age , body mass index , blood pressure , heart rate , LV mass index and intake of medications , we expressed effect sizes per 1-SD increment in the classifiers .\
RESULTS	HF1 was associated with 0.204 cm/s lower e ' peak velocity ( 95 % confidence interval , 0.057-0 .351 ; p = 0.007 ) and 0.145 higher E/e ' ratio ( 0.023-0 .268 ; p = 0.020 ) , while HF2 was associated with a 0.174 higher E/e ' ratio ( 0.046-0 .302 ; p = 0.008 ) .\
RESULTS	According to published definitions , 67 ( 9.0 % ) participants had impaired LV relaxation and 96 ( 12.9 % ) had elevated LV filling pressure .\
RESULTS	The odds of impaired relaxation associated with HF1 was 1.38 ( 1.01-1 .88 ; p = 0.043 ) and that of increased LV filling pressure associated with HF2 was 1.38 ( 1.00-1 .90 ; p = 0.052 ) .\
CONCLUSIONS	In a general population , the urinary proteome correlated with diastolic LV dysfunction , proving its utility for early diagnosis of this condition .\
\
###12228785\
OBJECTIVE	We sought to determine the value of electrophysiology ( EP ) testing in patients with ventricular fibrillation ( VF ) , ventricular tachycardia ( VT ) with syncope , or sustained VT in the setting of left ventricular dysfunction .\
BACKGROUND	Traditionally , EP testing is part of the workup of patients with sustained VT or VF .\
BACKGROUND	Recently , some have suggested that EP testing is unnecessary in these patients , many of whom are likely to receive an implantable cardioverter-defibrillator ( ICD ) .\
METHODS	Within a multicenter trial ( Antiarrhythmics Versus Implantable Defibrillators ) designed to evaluate whether drugs or ICD resulted in a better outcome , data were analyzed regarding EP testing .\
METHODS	Although this testing was not required , it was performed in > 50 % of patients .\
METHODS	Information regarding the results of EP testing was correlated to baseline clinical characteristics and outcome .\
RESULTS	Of 572 patients subjected to an EP test , 384 ( 67 % ) had inducible sustained VT or VF .\
RESULTS	Inducible patients were more likely to have coronary artery disease , previous infarction , and VT as their index arrhythmic event .\
RESULTS	Inducibility of VT or VF did not predict death or recurrent VT or VF .\
CONCLUSIONS	Information derived from EP testing in this patient population , particularly those with VF , is of limited value and may not be worth the risks and costs of the procedure , particularly in those patients likely to receive an ICD .\
\
###18479176\
OBJECTIVE	Lornoxicam is an NSAID used to obtain short-term relief of acute mild to moderate pain and symptomatic relief of pain and inflammation in rheumatoid arthritis and osteoarthritis .\
OBJECTIVE	The aim of this study was to compare and evaluate the pharmacokinetic parameters of lornoxicam 8 mg as quick-release ( QR ) tablet , standard tablet ( ST ) and intramuscular injection ( IM ) .\
METHODS	Eighteen healthy volunteers ( 9 male , 9 female ; average age 26.9 ( SD 3.0 ) years ; average body mass index 21.8 ( SD 2.3 ) kg/m2 were randomized to three different treatment groups .\
METHODS	Subjects received a single 8-mg dose of each lornoxicam formulation in a three-way crossover design on days 1 , 8 and 15 .\
METHODS	Lornoxicam plasma concentrations were obtained from baseline to 24 hours using high-pressure liquid chromatography .\
METHODS	The pharmacokinetic parameters area under the plasma concentration-time curve from zero to infinity ( AUCinfinity ) , maximum plasma concentration ( Cmax ) , time to maximum plasma concentration ( tmax ) , terminal half-life ( t1/2 ) ) and mean residence time ( MRT ) were calculated .\
RESULTS	Lornoxicam-QR was comparable with lornoxicam-ST and lornoxicam-IM regarding AUCinfinity , t1/2 and MRT .\
RESULTS	The AUCinfinity ratio ( 90 % CI ) was 1.07 ( 0.94 , 1.20 ) for lornoxicam-QR/lornoxicam-ST and 1.10 ( 0.97 , 1.24 ) for lornoxicam-QR/lornoxicam-IM .\
RESULTS	Cmax and tmax did not differ between lornoxicam-QR and lornoxicam-IM ( p = 0.66 and 0.07 , respectively ) .\
RESULTS	Both lornoxicam-QR and lornoxicam-IM showed significantly shorter tmax and significantly higher Cmax values than lornoxicam-ST .\
CONCLUSIONS	Lornoxicam-QR and lornoxicam-IM did not differ with respect to AUCinfinity , Cmax and tmax , but both lornoxicam-QR and lornoxicam-IM showed significantly shorter tmax and significantly higher Cmax values than lornoxicam-ST .\
\
###7948238\
OBJECTIVE	To compare the clinical outcome and cost-effectiveness of three techniques for continuous ambulatory peritoneal dialysis ( CAPD ) : the conventional spike technique ( C ) , the O-set ( O ) , and UVXD ( U , ultraviolet irradiation connection box ) .\
METHODS	A randomized and prospective comparison of three CAPD techniques .\
METHODS	A tertiary referral and a satellite dialysis center .\
METHODS	One hundred patients with end-stage renal failure between 10 and 70 years of age , with good hand-eye coordination and not anticipated to receive a living related transplant within 6 months .\
METHODS	Patients were randomized by referral to a table of random numbers to perform one of the three CAPD techniques .\
METHODS	Training time , details of peritonitis and exit-site infection ( ESI ) including the costs of antibiotic treatment , outpatient visits , hospital stays , technique , and patient survival were analyzed after a minimum follow-up period of one year .\
RESULTS	There were 38 , 31 , and 31 patients in groups C , O , and U , respectively , and the total observation periods were 838 , 802 , and 745 patient-months , respectively .\
RESULTS	The peritonitis rates for C , O , and U were 21.5 , 30.8 , and 29.8 patient-months/episode , respectively .\
RESULTS	The corresponding ESI rates were 16.4 , 14.9 , and 24 patient-months/episode , respectively .\
RESULTS	When the time from the commencement of CAPD to the first infection was expressed using the Kaplan-Meier life table analysis , 39.5 % , 67.7 % , and 61.3 % of patients in Groups C , O , and U were free from peritonitis at one year ( p = 0.088 ) .\
RESULTS	The corresponding figures for ESI were 52.6 % , 48.4 % , and 61.3 % ( p = 0.35 ) .\
RESULTS	There was no significant difference in technique survival in the three treatment groups .\
RESULTS	An analysis of the costs related to the use of antibiotics , outpatient visits , and hospital stays necessary for the treatment of peritonitis and ESI and those related to training time , additional equipment , and consumables required for the three CAPD techniques showed that , overall , the cost in O was the lowest , followed by U and C ( U.S. $ 158 , $ 170 , and $ 179 per patient-month , respectively ) .\
CONCLUSIONS	It was concluded that the O-set is a more cost-effective CAPD technique than UVXD , while both are more cost-effective than the conventional spike technique .\
\
###19743899\
OBJECTIVE	To evaluate the effectiveness of the oral application of a 0.12 % solution of chlorhexidine for prevention of respiratory tract infections among intensive care unit ( ICU ) patients .\
METHODS	The study design was a double-blind , randomized , placebo-controlled trial .\
METHODS	The study was performed in an ICU in a tertiary care hospital at a public university .\
METHODS	PATIENTS .\
METHODS	Study participants comprised 194 patients admitted to the ICU with a prospective length of stay greater than 48 hours , randomized into 2 groups : those who received chlorhexidine ( n = 98 ) and those who received a placebo ( n = 96 ) .\
METHODS	Oral rinses with chlorhexidine or a placebo were performed 3 times a day throughout the duration of the patient 's stay in the ICU .\
METHODS	Clinical data were collected prospectively .\
RESULTS	Both groups displayed similar baseline clinical features .\
RESULTS	The overall incidence of respiratory tract infections ( RR , 1.0 [ 95 % confidence interval [ CI ] , 0.63-1 .60 ] ) and the rates of ventilator-associated pneumonia per 1,000 ventilator-days were similar in both experimental and control groups ( 22.6 vs 22.3 ; P = .95 ) .\
RESULTS	Respiratory tract infection-free survival time ( 7.8 vs 6.9 days ; P = .61 ) , duration of mechanical ventilation ( 11.1 vs 11.0 days ; P = .61 ) , and length of stay ( 9.7 vs 10.4 days ; P = .67 ) did not differ between the chlorhexidine and placebo groups .\
RESULTS	However , patients in the chlorhexidine group exhibited a larger interval between ICU admission and onset of the first respiratory tract infection ( 11.3 vs 7.6 days ; P = .05 ) .\
RESULTS	The chances of surviving the ICU stay were similar ( RR , 1.08 [ 95 % CI , 0.72-1 .63 ] ) .\
CONCLUSIONS	Oral application of a 0.12 % solution of chlorhexidine does not prevent respiratory tract infections among ICU patients , although it may retard their onset .\
\
###19232940\
OBJECTIVE	To determine whether adding ephedrine to propofol is as effective as adding lidocaine at reducing injection pain , and its effects on hemodynamics .\
METHODS	Randomized , double-blinded , controlled trial .\
METHODS	District general hospital in the United Kingdom .\
METHODS	156 adult , ASA physical status I , II , and III patients undergoing elective or emergency general anesthesia .\
METHODS	Patients were randomized to one of three groups to receive one mL of 1 % lidocaine per 20 mL of 1 % propofol ( Group L ) , 15 mg of ephedrine per 20 mL of propofol ( Group E15 ) , or 30 mg of ephedrine per 20 mL of propofol ( Group E30 ) .\
RESULTS	Pain on injection , heart rate , and blood pressure at one-minute intervals for ten minutes were recorded .\
RESULTS	There was no significant difference in injection pain among groups .\
RESULTS	Group E30 had the least amount of hemodynamic change .\
CONCLUSIONS	Adding 30 mg of ephedrine to 20 mL of 1 % propofol is as effective as adding lidocaine in preventing injection pain , and it results in a more stable hemodynamic profile .\
\
###17072268\
BACKGROUND	Postanesthetic shivering ( PAS ) is a frequent side effect of general anesthesia .\
BACKGROUND	Previous reports on the incidence of PAS of propofol for the induction or maintenance of anesthesia have been controversial , but have not been studied in detail .\
BACKGROUND	The aim of the present study was to evaluate the incidence and severity of PAS in total intravenous anesthesia ( TIVA ) with propofol and remifentanil compared with an inhalative anesthesia .\
METHODS	After ethics committee approval and written informed consent from the patients , 53 patients scheduled for urologic , gynecologic , or surgical operations were studied for shivering postoperatively using a five-point rating scale .\
METHODS	They received desflurane-fentanyl based anesthesia ( n = 27 ) or TIVA with propofol and remifentanil ( n = 26 ) .\
METHODS	Hemodynamics and temperature were measured after induction of anesthesia ( T0 ) , and 5 min ( T1 ) , 15 min ( T2 ) , 30 min ( T3 ) , and 60 min ( T4 ) after reaching the postanesthetic care unit ( PACU ) .\
RESULTS	In the TIVA group , 18/26 ( 69.2 % ) patients suffered from PAS compared with 10/27 ( 37 % ) in the desflurane-fentanyl group ( P < 0.02 ) .\
RESULTS	The severity of shivering was significantly higher with TIVA than with desflurane ( P < 0.02 ) , whereas temperature showed no significant difference between the study groups .\
CONCLUSIONS	Postanesthetic shivering appears significantly more frequently and intensively after TIVA with propofol and remifentanil compared with an inhalative anesthesia with fentanyl and desflurane .\
\
###8199078\
OBJECTIVE	To investigate the magnitude and pattern of the changes in bone mass during five years of continuous and cyclic sequential oestrogen/progestin treatment .\
METHODS	Prospective study of normal , early postmenopausal women , initially a double-blind , placebo controlled trial , subsequently an open , controlled investigation .\
METHODS	Clinical physiology unit of a general hospital .\
METHODS	Sixty-eight normal , early postmenopausal women .\
RESULTS	1 .\
RESULTS	Continuous treatment resulted in significantly higher lumbar spine bone density than did sequential treatment ( P < 0.001 ) .\
RESULTS	Lumbar spine bone density was 19 % and 15 % , respectively , above that of untreated women after three years and onwards , and 10 % and 6 % , respectively , above the initial value ; 2 .\
RESULTS	Both regimens induced a more pronounced rise in lumbar spine bone density than in forearm bone mineral content ( P < 0.001 ) ; 3 .\
RESULTS	The spontaneous decline ( without treatment ) in lumbar spine bone density and forearm bone mineral content averaged 1.86 % and 1.90 % per year , respectively .\
RESULTS	4 .\
RESULTS	There was a significant bone loss from the lumbar spine during the last year of active treatment ( P < 0.001 ) .\
RESULTS	This would suggest that lumbar spine bone density rises to a certain level and subsequently declines .\
RESULTS	However , neither data pooled before computation nor data processed individually for each patient over five years allowed for any definite conclusions regarding the pattern of the long term skeletal response to combined oestrogen/progestin treatment .\
CONCLUSIONS	Five years treatment with oestradiol/norethisterone resulted in a substantial gain in bone mass .\
CONCLUSIONS	The highest values were found in the axial skeleton with daily administration of 2 mg oestradiol and 1 mg norethisterone .\
CONCLUSIONS	It is likely that bone mass after an absolute rise begins to decline after about four years of treatment .\
\
###16034044\
OBJECTIVE	Vascular endothelial growth factor A ( VEGF-A ) and vascular endothelial growth factor receptor 2 ( VEGFR2 ) are often coexpressed in breast cancer , and potentially affect cellular pathways and key proteins such as the estrogen receptor ( ER ) targeted by endocrine treatment .\
OBJECTIVE	We therefore explored the association between adjuvant tamoxifen treatment in breast cancer and expression of VEGF-A and VEGFR2 , as well as human epidermal growth factor receptor 2 ( HER2 ) , which represents a candidate gene product involved in tamoxifen resistance .\
METHODS	Immunohistochemical expression of tumor-specific VEGF-A , VEGFR2 , and HER2 was evaluated in tumor specimens from premenopausal breast cancer patients randomly assigned to 2 years of tamoxifen or no treatment ( n = 564 ) , with 14 years of follow-up .\
METHODS	Hormone receptor status was determined in 96 % of the tumors .\
RESULTS	VEGF-A , VEGFR2 , and HER2 were assessable in 460 , 472 , and 428 of the tumors , respectively .\
RESULTS	In patients with ER-positive and VEGFR2-low tumors , adjuvant tamoxifen significantly increased recurrence-free survival ( RFS ; [ HR ] hazard ratio for RFS , 0.53 ; P = .001 ) .\
RESULTS	In contrast , tamoxifen treatment had no effect in patients with VEGFR2-high tumors ( HR for RFS , 2.44 ; P = .2 ) .\
RESULTS	When multivariate interaction analyses were used , this difference in treatment efficacy relative to VEGFR2 expression status was statistically significant for both ER-positive ( P = .04 ) plus ER-positive and progesterone receptor-positive tumors .\
RESULTS	We found no significant difference in tamoxifen treatment effects in relation to VEGF-A or HER2 status .\
CONCLUSIONS	Tumor-specific expression of VEGFR2 was associated with an impaired tamoxifen effect in hormone receptor-positive premenopausal breast cancer .\
CONCLUSIONS	Tamoxifen in combination with VEGFR2 inhibitors might be a novel treatment approach for VEGFR2-expressing breast cancer , and such a treatment might restore the tamoxifen response .\
\
###23229850\
BACKGROUND	The aim of the present study was to evaluate the efficacy of cholestyramine ointment ( 15 % ) in reducing postoperative pain at rest and during defecation after open hemorrhoidectomy .\
METHODS	A total of 91 patients with third and fourth degree hemorrhoids undergoing open hemorrhoidectomy were included in this prospective , double-blind , randomized controlled trial .\
METHODS	The patients were randomly assigned to either cholestyramine ointment or placebo immediately after surgery , 12 h after surgery , and then every 8 h for 14 days .\
METHODS	The primary outcomes were intensity of pain at rest and during defecation , measured with a visual analog scale , and the analgesic requirement , measured by amount of tramadol consumption .\
RESULTS	The cholestyramine group had less postoperative pain than the placebo group at the 24th hour ( 1.84 2.54 vs. 4.07 3.35 ; P = 0.001 ) and 48th hour ( 0.18 0.88 vs. 3.57 3.45 ; P < 0.001 ) and less pain during defecation starting at the 48th hour ( 2.28 2.96 vs. 4.77 4.09 ; P = 0.001 ) .\
RESULTS	Similarly , the average tramadol consumption at hours 24 and 48 was significantly lower for the cholestyramine group ( 5.32 21.45 vs. 43.18 61.56 mg at 24 h , and 4.48 16.65 vs. 57.63 65.47 mg at 48 h ; P < 0.001 ) .\
RESULTS	The only adverse event was pruritus , which had a lower frequency in the cholestyramine group but the difference was not significant until postoperative week 4 ( P < 0.001 ) .\
CONCLUSIONS	Compared with placebo , cholestyramine ointment ( 15 % ) reduced postoperative pain at rest and on defecation , and consequently lowered the analgesic requirement after open hemorrhoidectomy .\
\
###16909322\
OBJECTIVE	Identify ways to increase the impact a well-known home-based intervention -- the Nurse Family Partnership ( NFP ) -- has on conception rates among teenage mothers .\
METHODS	Secondary analysis of data collected on 111 , 13-to-19 years old , primiparas who were visited in their homes by nurses during , and for 2 years after pregnancy .\
METHODS	Data bearing on assistance with family and career planning were culled from the nurses ' records .\
METHODS	These were graded on a 3-point scale .\
METHODS	Higher scores reflected more active , therapeutic interventions .\
METHODS	The primary outcome was repeat pregnancy .\
RESULTS	The pregnancy rate at 6 , 12 , and 24 months was 8.3 % , 18.4 % , and 28.1 % .\
RESULTS	Teenagers who conceived were less likely to have used contraceptives during the previous six months than those who did not .\
RESULTS	Almost everyone received the recommended number of visits .\
RESULTS	However , discussions and active interventions related to lapses in contraceptive use were only documented during 30 % of visits .\
RESULTS	Those who conceived had as many visits and discussions of this type as those who did not .\
RESULTS	Nurses rarely involved boyfriends and family .\
RESULTS	Other differences between teens that did and did not conceive support the NFP theoretical framework .\
CONCLUSIONS	Contrary to the stated aims of the intervention , the nurses rarely documented therapeutic interventions that could make repeated childbearing fit less harmoniously into the teenagers ' lives .\
CONCLUSIONS	The best way to strengthen the impact of this program on teen pregnancy rates is to deepen the nurses ' training so that they are able to intervene actively enough to bring about behavioral change in family planning .\
\
###23343224\
BACKGROUND	Oestrogen receptor ( ER ) status is important for the choice of systemic treatment of breast cancer patients .\
BACKGROUND	However , most data from randomised trials on the effect of adjuvant endocrine therapy according to ER status are based on the cytosol methods .\
BACKGROUND	Comparisons with immunohistochemical methods have given similar results .\
BACKGROUND	The aim of the present study was to examine whether different ER antibodies and heat-induced epitope retrieval ( HIER ) methods influence the prevalence of ER-positivity in primary breast cancer .\
METHODS	This study is based on patients included in a clinical trial designed to compare the effect of two years of adjuvant tamoxifen versus no adjuvant systemic treatment in premenopausal women .\
METHODS	From 1986 to 1991 , 564 patients from two study centres in Sweden were enrolled and randomised .\
METHODS	Patients were randomised independently of ER status .\
METHODS	In the present study , ER status was assessed on tissue microarrays with the three different ER antibody/HIER combinations : 1D5 in citrate pH 6 ( n = 390 ) , SP1 in Tris pH 9 ( n = 390 ) and PharmDx in citrate pH 6 ( n = 361 ) .\
RESULTS	At cut-offs of 1 % and 10 % , respectively , the prevalence of ER-positivity was higher with SP1 ( 75 % and 72 % ) compared with 1D5 ( 68 % and 66 % ) and PharmDx ( 66 % and 62 % ) .\
RESULTS	At these cut-offs , patients in the discordant groups ( SP1-positive and 1D5-negative ) seem to have a prognosis intermediate between those of the double-positive and double-negative groups .\
RESULTS	Comparison with the ER status determined by the cytosol-based methods in the discordant group also showed an intermediate pattern .\
RESULTS	The repeatability was good for all antibodies and cut-offs , with overall agreement 93 % .\
CONCLUSIONS	The present study shows that the choice of antibody and HIER method influences the prevalence of ER-positivity .\
CONCLUSIONS	We suggest that this be taken into consideration when choosing a cut-off for clinical decision making .\
\
###16333821\
BACKGROUND	Health-compromising behaviors among survivors of childhood cancer may increase their risks of cancer recurrence and the onset of chronic disease in adulthood .\
BACKGROUND	Regardless of whether such behaviors occur singly or in combination with one another , multiple behavioral risk factors must be identified and addressed early to promote better health outcomes within this special population .\
BACKGROUND	Adolescent survivors may be especially vulnerable , as reported rates of smoking and other risky behaviors are at or near levels of their healthy peers .\
BACKGROUND	The psychological literature suggests stress may play a role in risk behavior initiation and maintenance , including multiple behavioral risks , and that adolescent survivors are stress-prone .\
BACKGROUND	This report focuses on the prevalence and co-occurrence of three behavioral risk factors ( cigarette use , insufficient physical activity , and non-adherence to sun protection recommendations ) and describes stress-health behavior relationships in this special population .\
METHODS	All patients in this study ( n = 75 ) were adolescent survivors of childhood cancer and completed a baseline assessment of their health behaviors and stress as part of a randomized controlled trial of health promotion .\
RESULTS	Twenty-eight percent of the patients reported one of three risk factors , 12 % reported two of three risk factors , and 7 % reported all three risk factors .\
RESULTS	Non-adherence to sun protection was the single most common risk factor ; physical inactivity and non-adherent sun protection were the most common co-occurring risk factors .\
RESULTS	Greater age and stress were significantly associated with the presence of more behavioral risk factors .\
CONCLUSIONS	The evidence suggests interventions to reduce multiple health-compromising behaviors in these patients are warranted , and that efforts to address these patients ' personal and family stress levels are important as well .\
\
###11701294\
BACKGROUND	The effect of a combined influenza and pneumococcal immunization reminder letter on increasing influenza and pneumococcal immunization rates , and the timeliness of receiving immunizations after receipt of a reminder letter , have not been examined .\
BACKGROUND	This study addresses these issues using a sample of new Medicare beneficiaries residing in Hawaii .\
METHODS	Newly enrolled Medicare beneficiaries in Hawaii from 25 September 1995 through 31 August 1996 were randomly assigned to one of three groups : Group 1 , no letter ( n = 2144 ) ; Group 2 , influenza immunization reminder letter only ( n = 2213 ) ; or Group 3 , pneumococcal and influenza immunization reminder letter ( n = 2171 ) .\
METHODS	Health Care Financing Administration claims data were compared among groups .\
RESULTS	In Group 3 , the influenza immunization rate increased 3.8 percentage points ( n = 87 ; p = 0.017 ) compared with Group 1 .\
RESULTS	The Group 3 pneumococcal immunization rate increased 3.5 percentage points ( n = 78 ; p < 0.001 ) compared to Group 1 and 4.0 percentage points ( n = 86 ; p < 0.001 ) compared to Group 2 .\
RESULTS	Sixty-six beneficiaries in Group 3 received simultaneous pneumococcal and influenza immunizations , a significant difference compared to Group 1 or Group 2 .\
RESULTS	Increases in immunizations were observed immediately following the reminder letters and the effect persisted for 5 to 7 weeks .\
CONCLUSIONS	The combination letter increased both influenza and pneumococcal immunization rates and the simultaneous administration of immunizations without detrimental effect to influenza immunization rates .\
CONCLUSIONS	A combined reminder letter is inexpensive and recommended as part of a multicomponent campaign for adult immunization .\
\
###24506429\
OBJECTIVE	Soluble CD14 ( sCD14 ) is a monocyte activation marker associated with increased mortality in HIV infection .\
OBJECTIVE	We assessed 48-week changes in sCD14 and other inflammatory biomarkers in virologically suppressed , HIV-infected women switching to raltegravir ( RAL ) from a protease inhibitor ( PI ) or nonnucleoside reverse transcriptase inhibitor ( NNRTI ) .\
METHODS	HIV-infected women with central adiposity and HIV-1 RNA < 50 HIV-1 RNA copies/mL continued their thymidine-sparing nucleoside reverse transcriptase inhibitor ( NRTI ) backbone and were randomized to switch to open-label RAL at week 0 ( immediate ) or 24 ( delayed ) .\
METHODS	In an exploratory analysis , inflammatory biomarkers were measured on stored fasting plasma .\
RESULTS	Of the 37 evaluable subjects , 78 % were non-White ; the median age was 43 years , the median body mass index ( BMI ) was 32kg/m ( 2 ) and the median CD4 count was 558cells/L .\
RESULTS	At baseline , biomarker values were similar between groups .\
RESULTS	After 24 weeks , median sCD14 significantly declined in subjects switching to RAL [ -21 % ( P < 0.001 ) vs.PI / NNRTI -5 % ( P = 0.49 ) ; between-group P < 0.01 ] .\
RESULTS	After 48 weeks , immediate-switch subjects maintained this decline and delayed-switch subjects experienced a similar decline following the switch to RAL ( -10 % ; within-group P < 0.01 ) .\
RESULTS	Immediate-switch subjects also experienced an initial increase in tumour necrosis factor ( TNF ) - that was neither maintained after 48 weeks nor seen in delayed-switch subjects .\
RESULTS	After adjustment for multiple testing , only declines in sCD14 remained significant .\
CONCLUSIONS	In this randomized trial of women with central adiposity , a switch to RAL from a PI or NNRTI was associated with a statistically significant decline in sCD14 .\
CONCLUSIONS	Further studies are needed to determine whether integrase inhibitors have improved monocyte activation profiles compared with PIs and/or NNRTIs , and whether measured differences between antiretroviral agents translate to demonstrable clinical benefit .\
\
###15531320\
OBJECTIVE	To compare the extent of mucosal margins remaining unsutured at the end of external dacryocystorhinostomy ( DCR ) using single or double flap techniques and to evaluate the influence on outcome .\
METHODS	Prospective , consecutive case series .\
METHODS	The number and length of mucosal margins remaining unsutured at the end of external DCR were evaluated in 64 patients .\
METHODS	Mucosal anastomosis was performed using either a conservative ( group 1 ) or extended ( group 2 ) double flap , or a single flap ( group 3 ) dissection .\
METHODS	Patients were selected for group 1 if the regional anatomy permitted the desired dissection .\
METHODS	All other patients were randomized to group 2 or 3 .\
METHODS	The mean length of unsutured mucosal margins was calculated for each group .\
METHODS	Subjects were followed up to 12 months , with final success rate recorded .\
RESULTS	In groups 1 , 2 , and 3 respectively : 11 , 24 and 29 patients were recruited ; four , 12 , and 10 mucosal margins remained unsutured ; and the mean length of unsutured mucosal margins was 16.36 mm ( SD = 2.8 ) , 70.66 mm ( SD = 9.3 ) , and 62.00 mm ( SD = 6.0 ) .\
RESULTS	The mean length of unsutured mucosal margins was significantly different , although groups 1 and 2 collectively did not have a significantly different mean length of unsutured mucosal margin from group 3 .\
RESULTS	Mean follow-up was 11 months ( SD = 2.2 ) , 63 patients ( 98.43 % ) had a successful outcome with no significant difference among groups ( P = .429 ) .\
CONCLUSIONS	Different patterns of mucosal dissection in external DCR create a different number and extent of unsutured mucosal margins which do not appear to adversely affect the success rate of external DCR .\
\
###21112451\
OBJECTIVE	To compare the results of 6-month follow-ups for hospitalized patients who were divided into two groups of low - and high-intensity treatments for smoking cessation and compared to the results of standard hospital treatment .\
METHODS	A total of 2414 patients were screened .\
METHODS	Two hundred thirty-seven current smokers were randomly assigned to high-intensity intervention ( HII ; 30-min motivational interview plus seven routine telephone calls after hospital discharge ) or to low-intensity intervention ( LII ; 15-min counseling about the benefits of quitting ) and 80 comprised the usual care ( UC ) group .\
METHODS	Six months after hospital discharge , all participants were contacted by phone .\
METHODS	The main outcome measure was smoking cessation .\
RESULTS	The smoking-cessation rates were 44.9 % , 41.7 % and 26.3 % for the HII , LII and UC groups , respectively ( P = .03 ) .\
RESULTS	The multivariable analysis identified the following variables which are associated with the failure to stop smoking : the absence of a tobacco-related disease ( TRD ) , younger age and a low motivation for cessation at the initial contact .\
CONCLUSIONS	There was a great difference between intervention and nonintervention .\
CONCLUSIONS	The LII had an impact similar to the HII .\
CONCLUSIONS	The variables associated with no smoking cessation demonstrate the need for more personalized interventions for smokers who present lower indexes of motivation , are younger and do not have smoking-related diseases .\
\
###25486675\
BACKGROUND	Effective interventions are needed to reduce neurobehavioral impairments in children due to maternal alcohol use during pregnancy .\
BACKGROUND	Currently , health-counseling interventions have shown inconsistent results to reduce prenatal alcohol use .\
BACKGROUND	Thus , more research using health counseling is needed to gain more knowledge about the effectiveness of this type of intervention on reducing alcohol use during pregnancy .\
BACKGROUND	An alternative and promising strategy is computer tailoring .\
BACKGROUND	However , to date , no study has shown the effectiveness of this intervention mode .\
OBJECTIVE	The aim was to test the effectiveness of health counseling and computer tailoring on stopping and reducing maternal alcohol use during pregnancy in a Dutch sample of pregnant women using alcohol .\
METHODS	A total of 60 Dutch midwifery practices , randomly assigned to 1 of 3 conditions , recruited 135 health counseling , 116 computer tailoring , and 142 usual care respondents from February to September 2011 .\
METHODS	Health-counseling respondents received counseling from their midwife according to a health-counseling protocol , which consisted of 7 steps addressed in 3 feedback sessions .\
METHODS	Computer-tailoring respondents received usual care from their midwife and 3 computer-tailored feedback letters via the Internet .\
METHODS	Usual care respondents received routine alcohol care from their midwife .\
METHODS	After 3 and 6 months , we assessed the effect of the interventions on alcohol use .\
RESULTS	Multilevel multiple logistic regression analyses showed that computer-tailoring respondents stopped using alcohol more often compared to usual care respondents 6 months after baseline ( 53/68 , 78 % vs 51/93 , 55 % ; P = .04 ) .\
RESULTS	Multilevel multiple linear regression analyses showed that computer-tailoring respondents ( mean 0.35 , SD 0.31 units per week ) with average ( P = .007 ) or lower ( P < .001 ) alcohol use before pregnancy or with average ( P = .03 ) or lower ( P = .002 ) social support more strongly reduced their alcohol use 6 months after baseline compared to usual care respondents ( mean 0.48 , SD 0.54 units per week ) .\
RESULTS	Six months after baseline , 72 % ( 62/86 ) of the health-counseling respondents had stopped using alcohol .\
RESULTS	This 17 % difference with the usual care group was not significant .\
CONCLUSIONS	This is the first study showing that computer tailoring can be effective to reduce alcohol use during pregnancy ; health counseling did not effectively reduce alcohol use .\
CONCLUSIONS	Future researchers developing a health-counseling intervention to reduce alcohol use during pregnancy are recommended to invest more in recruitment of pregnant women and implementation by health care providers .\
CONCLUSIONS	Because pregnant women are reluctant to disclose their alcohol use to health professionals and computer tailoring preserves a person 's anonymity , this effective computer-tailoring intervention is recommended as an attractive intervention for pregnant women using alcohol .\
BACKGROUND	Dutch Trial Register NTR 2058 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2058 ( Archived by WebCite at http://www.webcitation.org/6NpT1oHol ) .\
\
###21143943\
BACKGROUND	Observational studies have documented a potential protective effect of physical exercise in older adults who are at risk for developing Alzheimer 's disease .\
BACKGROUND	The Fitness for the Ageing Brain II ( FABS II ) study is a multicentre randomized controlled clinical trial ( RCT ) aiming to determine whether physical activity reduces the rate of cognitive decline among individuals with Alzheimer 's disease .\
BACKGROUND	This paper describes the background , objectives of the study , and an overview of the protocol including design , organization and data collection methods .\
METHODS	The study will recruit 230 community-dwelling participants diagnosed with Alzheimer 's disease .\
METHODS	Participants will be randomly allocated to two treatment groups : usual care group or 24-week home-based program consisting of 150 minutes per week of tailored moderate physical activity .\
METHODS	The primary outcome measure of the study is cognitive decline as measured by the change from baseline in the total score on the Alzheimer 's disease Assessment Scale-Cognitive section .\
METHODS	Secondary outcomes of interest include behavioral and psychological symptoms , quality of life , functional level , carer burden and physical function ( strength , balance , endurance , physical activity ) .\
METHODS	Primary endpoints will be measured at six and twelve months following the baseline assessment .\
CONCLUSIONS	This RCT will contribute evidence regarding the potential benefits of a systematic program of physical activity as an affordable and safe intervention for people with Alzheimer 's disease .\
CONCLUSIONS	Further , if successful , physical activity in combination with usual care has the potential to alleviate the symptoms of Alzheimer 's disease and improve its management and the quality of life of patients and their carers .\
BACKGROUND	Australia New Zealand Clinical Trials Registry ACTRN12609000755235 .\
\
###19074488\
OBJECTIVE	To examine the psychometric properties of the Chinese version of Swanson , Nolan and Pelham IV Scale ( SNAP-IV ) - Teacher Form .\
METHODS	The sample included a representative sample of 3,653 first to eighth graders ( boys , 52.3 % ) and 190 children diagnosed with ADHD ( aged 6-15 ) .\
METHODS	Teachers completed the Chinese versions of the SNAP-IV , and Strengths and Difficulties Questionnaire .\
RESULTS	The confirmatory factor analysis revealed a four-factor structure ( inattention , hyperactivity , impulsivity , and opposition ) with an adequate fit ( Comparative Fit Index = 0.990 ; root mean square error of approximation = 0.058 ) .\
RESULTS	The test-retest reliability ( intraclass correlations = 0.60-0 .84 ) , internal consistency ( alpha = .88 -.95 ) , and concurrent validity ( Pearson correlations = 0.61-0 .84 ) were satisfactory .\
RESULTS	Children with both ADHD and oppositional defiant/conduct disorders had the highest scores , followed by children with ADHD only who had intermediate scores and then school-based participants who had the lowest scores .\
CONCLUSIONS	Our findings suggest that the Chinese SNAP-IV-Teacher Form is a reliable and valid instrument for rating ADHD and oppositional symptoms ( ClinicalTrials.Gov number , NCT00491361 ) .\
\
###22789494\
OBJECTIVE	To evaluate intraocular pressure ( IOP ) measurements 24 months after laser-assisted subepithelial keratectomy ( LASEK ) with 3 tonometry methods-Goldmann applanation tonometry ( GAT ) , Pascal dynamic contour tonometry ( DCT ) , and applanation resonance tonometry ( ART ) - and to compare them with measurements taken preoperatively and 3 and 6 months postoperatively .\
METHODS	Department of Ophthalmology , Ume University , Ume , Sweden .\
METHODS	Prospective randomized single-center .\
METHODS	One randomized eye per person from myopic healthy individuals who had LASEK was included .\
METHODS	Visual acuity , central corneal thickness ( CCT ) , corneal curvature , and IOP were measured at all time points .\
METHODS	Six IOP measurements were performed per method , with a 5-minute lapse between methods .\
RESULTS	The study evaluated 38 eyes .\
RESULTS	Two years after LASEK , dynamic ART was the only method that did not measure significantly lower IOP than before LASEK ( mean -0.2 mm Hg 1.6 [ SD ] ) .\
RESULTS	The greatest difference was with GAT ( mean -1.9 1.7 mm Hg ) followed by static ART ( mean -1.2 1.6 mm Hg ) and then DCT ( mean -0.9 1.3 mm Hg ) .\
RESULTS	All methods measured significantly lower IOP at 3 months and 6 months .\
CONCLUSIONS	Dynamic ART , which analyses IOP measurement during indentation , showed no significant difference in measured IOP after 24 months .\
CONCLUSIONS	The convex tip of the ART device and the continuous sampling of data during corneal indentation seem to be factors in why dynamic ART was less affected by corneal properties and therefore more suitable for IOP measurement in LASEK-treated eyes , although this must be confirmed in larger trials .\
\
###18478944\
OBJECTIVE	To investigate the effect of target-controlled infusion sufentanil in different doses combined with inhalation anesthesia at 0.9 minimum alveolar concentration ( MAC ) on the intraoperative hemodynamics and postoperative recovery of spontaneous breathing .\
METHODS	Sixty patients aged 18-65 , weighing 45-80 kg , undergoing colectomy or pedical screw intermix were randomized into 3 groups : Groups S3 , S4 , and S5 to receive sufentanil at the fixed target plasma concentrations of 0.3 , 0.4 , and 0.5 ng/ml respectively in combination of nitrogen monoxide inhalation at 0.9 MAC .\
METHODS	The arterial blood pressure ( ABP ) , heart rate ( HR ) , electrocardiogram ( ECG ) , and pulse blood oxygen saturation during anesthesia were monitored , the time between the termination of anesthetic use and recovery of spontaneous breathing and extubation were observed , and the use of vasoactive drug and other intravenous anesthetics were recorded .\
RESULTS	The BP and HR were nearly stable during the anesthesia in three groups .\
RESULTS	The values of time from termination of anesthesia to recovery of spontaneous breathing of Groups S2 , S3 , and S5 were ( 3.3 + / - 2.0 ) min , ( 2.8-2 .5 ) min , and ( 6.1-3 .4 ) min ) respectively without significant differences among them .\
RESULTS	The time from termination of anesthetic use to extubation of Group S5 was 14.6 + / - 10.9 min , significantly longer than those of Groups S3 and S4 : [ ( 9.6 + / - 8.0 ) and ( 9.4 + / - 6.4 ) min , both P < 0.05 ] .\
CONCLUSIONS	When the concentration of inhalation anesthetic is at 0.9 MAC , the target plasma sufentanil concentration of 0.3 ng/ml is adequate in anesthesia .\
CONCLUSIONS	If sufentanil infusion was terminated 50 min before the end of surgery , the patients can recover safely and quickly .\
\
###11593871\
OBJECTIVE	This prospective , randomised , double-blind study was designed to compare the incidence and intensity of pain on injection of propofol formulated in a mixture of medium - and long-chain triglycerides , Propofol-MCT/LCT 1 % ( Propofol-Lipuro , B. Braun , Germany ) with propofol in a commonly used emulsion of long-chain triglycerides , Propofol-LCT 1 % ( Disoprivan , Zeneca ) in children undergoing elective surgical procedures .\
METHODS	After approval of the local ethics committee 40 children , aged 7-14 years , were enrolled in the study .\
METHODS	Premedication was with 5-10 mg diazepam orally one hour before induction of anesthesia .\
METHODS	In the beginning 20 % of the calculated dose of Propofol for induction was injected into a separate venous cannula in a dorsal vein of the hand ; patients were observed for expressing pain spontaneously during injection patients or were asked to describe the sensations after 10 s. Withdrawal of the arm during injection was also noted .\
RESULTS	Significantly more children reported pain on injection of propofol-LCT compared to Propofol-MCT/LCT ( 25 % vs , 10 % ) and significantly more children retracted their arm during injection of propofol-LCT ( 40 % vs. 10 % ) .\
CONCLUSIONS	Propofol-MCT/LCT 1 % ( Propofol-Lipuro ) for induction of anesthesia produced significantly less pain on injection and significantly less drawing back of the arm when compared to Propofol-LCT ( Disoprivan ) .\
CONCLUSIONS	Thus , with respect to pain on injection Propofol-MCT/LCT appears to be superior to Propofol-LCT in children aged 7-14 years .\
\
###23280223\
OBJECTIVE	In threatened preterm labor , maintenance tocolysis with nifedipine , after an initial course of tocolysis and corticosteroids for 48 hours , may improve perinatal outcome .\
OBJECTIVE	To determine whether maintenance tocolysis with nifedipine will reduce adverse perinatal outcomes due to premature birth .\
METHODS	APOSTEL-II ( Assessment of Perinatal Outcome with Sustained Tocolysis in Early Labor ) is a double-blind , placebo-controlled trial performed in 11 perinatal units including all tertiary centers in The Netherlands .\
METHODS	From June 2008 to February 2010 , women with threatened preterm labor between 26 weeks ( plus 0 days ) and 32 weeks ( plus 2 days ) gestation , who had not delivered after 48 hours of tocolysis and a completed course of corticosteroids , were enrolled .\
METHODS	Surviving infants were followed up until 6 months after birth ( ended August 2010 ) .\
METHODS	Randomization assigned 406 women to maintenance tocolysis with nifedipine orally ( 80 mg/d ; n = 201 ) or placebo ( n = 205 ) for 12 days .\
METHODS	Assigned treatment was masked from investigators , participants , clinicians , and research nurses .\
METHODS	Primary outcome was a composite of adverse perinatal outcomes ( perinatal death , chronic lung disease , neonatal sepsis , intraventricular hemorrhage > grade 2 , periventricular leukomalacia > grade 1 , or necrotizing enterocolitis ) .\
METHODS	Analyses were completed on an intention-to-treat basis .\
RESULTS	Mean ( SD ) gestational age at randomization was 29.2 ( 1.7 ) weeks for both groups .\
RESULTS	Adverse perinatal outcome was not significantly different between groups : 11.9 % ( 24/201 ; 95 % CI , 7.5 % -16.4 % ) for nifedipine vs 13.7 % ( 28/205 ; 95 % CI , 9.0 % -18.4 % ) for placebo ( relative risk , 0.87 ; 95 % CI , 0.53-1 .45 ) .\
CONCLUSIONS	In patients with threatened preterm labor , nifedipine-maintained tocolysis did not result in a statistically significant reduction in adverse perinatal outcomes when compared with placebo .\
CONCLUSIONS	Although the lower than anticipated rate of adverse perinatal outcomes in the control group indicates that a benefit of nifedipine can not completely be excluded , its use for maintenance tocolysis does not appear beneficial at this time .\
BACKGROUND	trialregister.nl Identifier : NTR1336 .\
\
###21467563\
BACKGROUND	Hip arthroplasty frequently requires potent postoperative analgesia , often provided with an epidural or posterior lumbar plexus local anesthetic infusion .\
BACKGROUND	However , American Society of Regional Anesthesia guidelines now recommend against epidural and continuous posterior lumbar plexus blocks during administration of various perioperative anticoagulants often administered after hip arthroplasty .\
BACKGROUND	A continuous femoral nerve block is a possible analgesic alternative , but whether it provides comparable analgesia to a continuous posterior lumbar plexus block after hip arthroplasty remains unclear .\
BACKGROUND	We therefore tested the hypothesis that differing the catheter insertion site ( femoral versus posterior lumbar plexus ) after hip arthroplasty has no impact on postoperative analgesia .\
METHODS	Preoperatively , subjects undergoing hip arthroplasty were randomly assigned to receive either a femoral or a posterior lumbar plexus stimulating catheter inserted 5 to 15 cm or 0 to 1 cm past the needle tip , respectively .\
METHODS	Postoperatively , patients received perineural ropivacaine , 0.2 % ( basal 6 mL/hr , bolus 4 mL , 30-minute lockout ) for at least 2 days .\
METHODS	The primary end point was the average daily pain scores as measured with a numeric rating scale ( 0-10 ) recorded in the 24-hour period beginning at 07:30 the morning after surgery , excluding twice-daily physical therapy sessions .\
METHODS	Secondary end points included pain during physical therapy , ambulatory distance , and supplemental analgesic requirements during the same 24-hour period , as well as satisfaction with analgesia during hospitalization .\
RESULTS	The mean ( SD ) pain scores for subjects receiving a femoral infusion ( n = 25 ) were 3.6 ( 1.8 ) versus 3.5 ( 1.8 ) for patients receiving a posterior lumbar plexus infusion ( n = 22 ) , resulting in a group difference of 0.1 ( 95 % confidence interval -0.9 to 1.2 ; P = 0.78 ) .\
RESULTS	Because the confidence interval was within a prespecified -1.6 to 1.6 range , we conclude that the effect of the 2 analgesic techniques on postoperative pain was equivalent .\
RESULTS	Similarly , we detected no differences between the 2 treatments with respect to the secondary end points , with one exception : subjects with a femoral catheter ambulated a median ( 10th-90th percentiles ) 2 ( 0-17 ) m the morning after surgery , in comparison with 11 ( 0-31 ) m for subjects with a posterior lumbar plexus catheter ( data nonparametric ; P = 0.02 ) .\
CONCLUSIONS	After hip arthroplasty , a continuous femoral nerve block is an acceptable analgesic alternative to a continuous posterior lumbar plexus block when using a stimulating perineural catheter .\
CONCLUSIONS	However , early ambulatory ability suffers with a femoral infusion .\
\
###12563720\
OBJECTIVE	To assess the efficacy and safety of Zyrtec drops which is a patent product of UCB pharma in treatment of allergy rhinitis in children .\
METHODS	A total of 47 children of both sexes aged between 2 to 6 years with allergy rhinitis ( AR ) were included in this study , who were randomly selected to be treated with Zyrtec ( Cetirizine 2 HCL ) drops 5 mg daily for 3 weeks .\
METHODS	Investigators made a global evaluation with symptom scores before treatment and once a week for 3 weeks after treatment .\
RESULTS	An improvement was shown in each week after treatment with statistical significance ( P < 0.01 ) .\
RESULTS	Zyrtec drops provided an excellent improvement at the end of the study .\
RESULTS	Tolerance was good .\
CONCLUSIONS	For acting fast , potent , good tolerance and convenience in use , Zyrtec drops is a better treatment in AR in kids .\
\
###22237003\
BACKGROUND	The IMPACT study was a randomized , double-blind study comparing 100 to 200 days of VGCV prophylaxis ( 900 mg once daily ) in D + / R - kidney transplant recipients .\
BACKGROUND	Although extending the duration of prophylaxis resulted in a significant reduction in confirmed cytomegalovirus ( CMV ) disease ( 100-day : 36.8 % vs 200-day : 16.1 % ( 1 ) ) , the consequence of extending the duration of prophylaxis on the development of viral resistance remains unknown .\
OBJECTIVE	To determine whether extending valganciclovir prophylaxis from 100 days to 200 days increased the incidence of ganciclovir resistance .\
METHODS	Genotypic analysis of CMV UL97 and UL54 was conducted on virus isolated from patients meeting the predefined resistance analysis criteria ( RAC ) .\
RESULTS	A greater number of patients met the RAC in the 100 day prophylaxis arm ( 50/163 ; 31 % ) compared to the 200 day prophylaxis arm ( 22/155 ; 14 % ) .\
RESULTS	Sequence data were successfully generated for all 200-day patients and 48/50 100-day patients .\
RESULTS	Three patients in each treatment arm ( 100 day : 3/163 ( 1.8 % ) vs 200 day : 3/155 ( 1.9 % ) ) had a single known valganciclovir resistance mutation detected ( 100 day : UL97 gene : M460V , C592G twice ; 200 day : UL97 gene : C603W , M460V and UL54 gene : P522S ) .\
RESULTS	Overall , a resistance mutation was more likely to be detected if the patient met the RAC during prophylaxis ( 5/12 ( 42 % ) ) compared to post-prophylaxis ( 1/58 ( 2 % ) ) .\
RESULTS	All six patients with known ganciclovir resistance mutations cleared the virus ; three cleared virus without treatment and three cleared virus following treatment .\
CONCLUSIONS	Extending valganciclovir prophylaxis from 100 days to 200 days did not significantly affect the incidence of ganciclovir resistance .\
\
###17205469\
BACKGROUND	Treatment of second-stage sleeping sickness relies mainly on melarsoprol .\
BACKGROUND	Nifurtimox has been successfully used to cure melarsoprol-refractory sleeping sickness caused by Trypanosoma brucei gambiense infection .\
METHODS	An open , randomized trial was conducted to test for equivalence between the standard melarsoprol regimen and 3 other regimens , as follows : standard melarsoprol therapy ( 3 series of 3.6 mg/kg/day intravenously [ iv ] for 3 days , with 7-day breaks between the series ) ; 10-day incremental-dose melarsoprol therapy ( 0.6 mg/kg iv on day 1 , 1.2 mg/kg iv on day 2 , and 1.8 mg/kg iv on days 3-10 ) ; nifurtimox monotherapy for 14 days ( 5 mg/kg orally 3 times per day ) ; and consecutive 10-day melarsoprol-nifurtimox combination therapy ( 0.6 mg/kg iv melarsoprol on day 1 , 1.2 mg/kg iv melarsoprol on day 2 , and 1.2 mg/kg/day iv melarsoprol combined with oral 7.5 mg/kg nifurtimox twice a day on days 3-10 ) .\
METHODS	Primary outcomes were relapse , severe adverse events , and death attributed to treatment .\
RESULTS	A total of 278 patients were randomized .\
RESULTS	The frequency of adverse events was similar between the standard melarsoprol regimen and the other regimens .\
RESULTS	Encephalopathic syndromes occurred in all groups and caused all deaths that were likely due to treatment .\
RESULTS	Relapses ( n = 48 ) were observed only with the 3 monotherapy regimens .\
CONCLUSIONS	A consecutive 10-day low-dose melarsoprol-nifurtimox combination is more effective than the standard melarsoprol regimen .\
\
###21786110\
OBJECTIVE	To test megavolt cone-beam CT ( MV-CBCT ) in order to evaluate setup errors in prostate radiotherapy .\
METHODS	The setup of 9 patients was verified weekly by electronic portal imaging ( EPI ) and MV-CBCT , both per-formed in the same treatment session .\
METHODS	EPI were compared with digitally reconstructed radiographies ( DRRs ) .\
METHODS	MV-CBCTs were matched to simulation CTs by manual registration based on bone markers ( BMR ) , by manual registration based on soft tissues ( STR ) - rectum , bladder , and seminal vesicles - and by automatic registration ( AR ) performed by a mutual information algorithm .\
METHODS	Shifts were evaluated along the three main axes : anteroposterior ( AP ) , craniocaudal ( CC ) , and laterolateral ( LL ) .\
METHODS	Finally , in 4 additional patients showing intraprostatic calcifications , the calcification mismatch error was used to evaluate the three MV-CBCT matching methods .\
RESULTS	A total of 50 pairs of orthogonal EPIs and 50 MV-CBCTs were analyzed .\
RESULTS	Assuming an overall tolerance of 2 mm , no significant differences were observed comparing EPI vs BMR in any axis .\
RESULTS	A significant difference ( p < 0.001 ) was observed along the AP axis comparing EPI vs AR and EPI vs STR .\
RESULTS	On the calcification data set ( 22 measures ) , the calcification mismatch along the AP direction was significantly lower ( p < 0.05 ) after STR than after BMR or AR .\
CONCLUSIONS	Bone markers were not an effective surrogate of the target position and significant differences were observed comparing EPI or BMR vs STR , supporting the assessment of soft tissue position by MVCBs to verify and correct patient setup in prostate radiotherapy .\
\
###24406481\
OBJECTIVE	The Sibutramine Cardiovascular OUTcomes ( SCOUT ) trial showed a significantly increased relative risk of nonfatal cardiovascular events , but not mortality , in overweight and obese subjects receiving long-term sibutramine treatment with diet and exercise .\
OBJECTIVE	We examined the relationship between early changes ( both increases and decreases ) in body weight and blood pressure , and the impact of these changes on subsequent cardiovascular outcome events .\
METHODS	A total of 9804 male and female subjects , aged 55 years or older , with a body mass index of 27-45kgm ( -2 ) were included in this current subanalysis of the SCOUT trial .\
METHODS	Subjects were required to have a history of cardiovascular disease and/or type 2 diabetes mellitus with at least one cardiovascular risk factor ( hypertension , dyslipidemia , current smoking or diabetic nephropathy ) to assess cardiovascular outcomes .\
METHODS	Post hoc subgroup analyses of weight change ( categories ) and blood pressure were performed overall and by treatment group ( 6-week sibutramine followed by randomized placebo or continued sibutramine ) .\
METHODS	The primary outcome event ( POE ) was a composite of nonfatal myocardial infarction , nonfatal stroke , resuscitated cardiac arrest or cardiovascular death .\
METHODS	Time-to-event analyses of the POE were performed using Cox regression models with factors for treatment , subgroups and interactions .\
RESULTS	During the initial 6-week sibutramine treatment period , systolic blood pressure decreased progressively with increasing weight loss in hypertensive subjects ( -8.110.5 mmHg with < 5kg weight loss to -10.811.0 mmHg with 5kg weight loss ) .\
RESULTS	The highest POE incidence occurred mainly in groups with increases in both weight and blood pressure .\
RESULTS	However , with long-term sibutramine treatment , a markedly lower blood pressure tended to increase POEs .\
CONCLUSIONS	Modest weight loss and modest lower blood pressure each reduced the incidence of cardiovascular events , as expected .\
CONCLUSIONS	However , the combination of early marked weight loss and rapid blood pressure reduction seems to be harmful in this obese elderly cardiovascular diseased population .\
\
###23895814\
BACKGROUND	The impact of nonpersistence on events and of events on persistence is unclear .\
BACKGROUND	We studied the effects of nonpersistence on outcomes and events on nonadherence in a randomized placebo controlled trial in 40 countries on 25,620 patients .\
METHODS	In the ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial ( ONTARGET ) , persistent patients ( n = 20,991 ) were compared with individuals who had permanently stopped study medications ( n = 4,629 ) .\
RESULTS	Older age , female gender , less physical activity , less education , and history of stroke/transient ischemic attack , depression , and diabetes were associated with nonpersistence .\
RESULTS	After adjustment , nonpersistence was associated with the composite end point of cardiovascular death , myocardial infarction , stroke , or hospitalization for heart failure ( hazard ratio 1.24 , 99 % CI 1.09-1 .40 , P < .0001 ) , cardiovascular death alone ( 1.87 , 1.60-2 .19 , P < .0001 ) , and heart failure hospitalization alone ( 1.32 , 1.04-1 .67 , P = .0023 ) .\
RESULTS	Cardiovascular events increased when medications were stopped , whereas noncardiovascular outcomes did not .\
RESULTS	Nonpersistence rapidly increased within the first year after nonfatal events such as myocardial infarction ( hazard ratio 3.37 , 99 % CI 2.72-4 .16 , P < .0001 ) , stroke ( 3.25 , 2.59-4 .07 , P < .0001 ) , and hospitalization for heart failure ( 3.67 , 2.95-4 .57 , P < .0001 ) .\
RESULTS	Persistence was poorer with more frequent and earlier events .\
RESULTS	Patients stopping medication after an event were at greater risk for subsequent events .\
CONCLUSIONS	Improving medications persistence could interrupt this vicious circle and may improve outcomes .\
\
###22452928\
BACKGROUND	Exposure to wood smoke is associated with respiratory symptoms , whereas knowledge on systemic effects is limited .\
BACKGROUND	We investigated effects on systemic inflammation , oxidative stress and microvascular function ( MVF ) after controlled wood smoke exposure .\
METHODS	In a randomised , double-blinded , cross-over study 20 non-smoking atopic subjects were exposed at rest to 14 , 220 , or 354 g/m3 of particles from a well-burning modern wood stove for 3 h in a climate controlled chamber with 2 week intervals .\
METHODS	We investigated the level of oxidatively damaged DNA , inflammatory markers and adhesion molecules before and 0 , 6 and 20 h after exposure .\
METHODS	Six h after exposure we measured MVF non-invasively by digital peripheral artery tonometry following arm ischemia .\
RESULTS	The MVF score was unaltered after inhalation of clean air ( 1.58 0.07 ; mean SEM ) , low ( 1.51 0.07 ) or high ( 1.61 0.09 ) concentrations of wood smoke particles in atopic subjects , whereas unexposed non-atopic subjects had higher score ( 1.91 0.09 ) .\
RESULTS	The level of oxidatively damaged DNA , mRNA of ITGAL , CCL2 , TNF , IL6 , IL8 , HMOX1 , and OGG1 and surface marker molecules ICAM1 , ITGAL and L-selectin in peripheral blood mononuclear cells were not affected by inhalation of wood smoke particles .\
CONCLUSIONS	Exposure to wood smoke had no effect on markers of oxidative stress , DNA damage , cell adhesion , cytokines or MVF in atopic subjects .\
\
###10091816\
OBJECTIVE	This analysis was performed to assess whether beta-adrenergic blocking agent use is associated with reduced mortality in the Studies of Left Ventricular Dysfunction ( SOLVD ) and to determine if this relationship is altered by angiotensin-converting enzyme ( ACE ) inhibitor use .\
BACKGROUND	The ability of beta-blockers to alter mortality in patients with asymptomatic left ventricular dysfunction is not well defined .\
BACKGROUND	Furthermore , the effect of beta-blocker use , in addition to an ACE inhibitor , on these patients has not been fully addressed .\
METHODS	This retrospective analysis evaluated the association of baseline beta-blocker use with mortality in 4,223 mostly asymptomatic Prevention trial patients , and 2,567 symptomatic Treatment trial patients .\
RESULTS	The 1,015 ( 24 % ) Prevention trial patients and 197 ( 8 % ) Treatment trial patients receiving beta-blockers had fewer symptoms , higher ejection fractions and different use of medications than patients not receiving beta-blockers .\
RESULTS	On univariate analysis , beta-blocker use was associated with significantly lower mortality than nonuse in both trials .\
RESULTS	Moreover , a synergistic reduction in mortality with use of both a beta-blocker and enalapril was suggested in the Prevention trial .\
RESULTS	After adjusting for important prognostic variables with Cox multivariate analysis , the association of beta-adrenergic blocking agent use with reduced mortality remained significant for Prevention trial patients receiving enalapril .\
RESULTS	Lower rates of arrhythmic and pump failure death and risk of death or hospitalization for heart failure were observed .\
CONCLUSIONS	The combination of a beta-blocker and enalapril was associated with a synergistic reduction in the risk of death in the SOLVD Prevention trial .\
\
###17239657\
OBJECTIVE	To compare the efficacy , safety and tolerability of sumanirole with placebo in patients with idiopathic restless legs syndrome ( RLS ) .\
METHODS	In this double-blind , placebo-controlled , randomized , parallel-group , dose-response study , 270 patients with idiopathic RLS were enrolled and randomized to receive sumanirole 0.5 , 1.0 , 2.0 , or 4.0 mg , or placebo .\
METHODS	The primary efficacy endpoint was mean change of the total score of the International Restless Legs Scale ( IRLS-10 ) , a 10-item scale , from baseline to end of maintenance .\
METHODS	Secondary assessments included polysomnography ( PSG ) variables .\
RESULTS	Treatment with sumanirole was well tolerated .\
RESULTS	Mean change in IRLS-10 showed no statistically significant change compared with placebo at any dose , although the mean change with the 4.0-mg dose was numerically greater than the other doses and placebo .\
RESULTS	PSG variables , specifically the periodic leg movements during sleep , showed statistically significant dose-related improvement in favor of sumanirole .\
RESULTS	Consistent with earlier multinational , multicenter studies in RLS , high placebo response rates were seen with IRLS-10 but not with PSG variables .\
CONCLUSIONS	Given data published in Parkinson 's disease , the dose range of sumanirole selected here may have been too low .\
CONCLUSIONS	Alternatively , dopamine D ( 2 ) selective agents could be intrinsically less effective than agonists with combined D ( 2 ) / D ( 3 ) activity .\
CONCLUSIONS	Sumanirole demonstrated an excellent safety profile .\
\
###21344812\
OBJECTIVE	To study the effect of calf stretching box usage in increasing the compliance of performing calf stretching exercise as compared to the conventional exercise method .\
OBJECTIVE	To study the effect of calf stretching box usage in decreasing the calf muscle tightness and complications as compared to the conventional exercise method .\
METHODS	Eighty patients older than 45 years old with calf muscles tightness were enrolled in a prospective , randomized single-blinded controlled trial at the out-patient Rehabilitation medicine clinic , Siriraj Hospital , Bangkok Thailand between April and August 2009 .\
METHODS	Patients were randomized into two groups , the study group ( stretching by using calf stretching box ) and the control group ( stretching by the conventional exercise method ) .\
METHODS	Patients in both groups were asked to hold the stretch for at least 1 minute and to perform the stretching program at least two times per day , every day for two weeks .\
METHODS	Furthermore , they were asked to record the real frequency and duration of their exercise and complications in a logbook every day .\
RESULTS	Thirty-eight patients in each group completed the study .\
RESULTS	The baseline characteristics of the patients in both groups were similar .\
RESULTS	The study group had higher frequency and longer duration of performing calf stretching exercise than the control group .\
RESULTS	They also reported more decrease of calf muscle tightness with less pain complication ( shoulder pain , knee pain , low back pain , and calf muscle pain ) than the control group ( p < 0.05 ) .\
RESULTS	However , there were no significant differences in the ( between before and after ) numbers of taut bands , trigger points , and tender points of calf muscle and degree of ankle range of motion between the two groups .\
CONCLUSIONS	Stretching calf muscle with calf stretching box can increase compliance , decrease calf muscle tightness and decrease complications when compared with the conventional exercise method .\
\
###25371147\
OBJECTIVE	Worsening heart failure ( WHF ) in the first 7 days after an admission for acute HF ( AHF ) has been proposed as a therapeutic target in several recent AHF studies and was a co-primary endpoint of the VERITAS studies .\
RESULTS	Patients were randomized within 24h of admission for AHF .\
RESULTS	WHF was defined as worsening or persistent signs and symptoms of HF requiring additional intravenous or mechanical therapy for HF or death within 7 days of randomization .\
RESULTS	Multivariable models were developed to predict the time to WHF through day 7 .\
RESULTS	Unadjusted and multivariable-adjusted associations of WHF with the length of stay ( LOS ) of the index hospitalization , and 30 - and 90-day outcomes were estimated .\
RESULTS	WHF occurred by day 7 in 27 % of the 1347 patients enrolled .\
RESULTS	Age , co-morbidities , and markers of HF severity were moderately predictive of WHF ; the C-index for a multivariable model for WHF was 0.66 .\
RESULTS	After multivariable adjustment for baseline characteristics , WHF was associated with an increase in LOS of 4.33 days [ 95 % confidence interval ( CI ) 3.54-5 .13 days ] , a hazard ratio ( HR ) for 30-day HF readmission or death of 2.43 ( 95 % CI 1.75-3 .40 ) , and a HR for 90-day mortality of 2.57 ( 95 % CI 1.81-3 .65 ) , all with P < 0.0001 .\
RESULTS	The associations of WHF with these outcomes remained largely unchanged after adjustment for both baseline characteristics and changes in markers of renal and hepatic dysfunction during the first day of admission .\
CONCLUSIONS	In patients admitted for AHF , WHF is a significant clinical event that is associated with delays in discharge and higher rates for readmission and death .\
\
###20047672\
BACKGROUND	Systematic reviews have identified a range of brief interventions which increase physical activity in previously sedentary people .\
BACKGROUND	There is an absence of evidence about whether follow up beyond three months can maintain long term physical activity .\
BACKGROUND	This study assesses whether it is worth providing motivational interviews , three months after giving initial advice , to those who have become more active .\
METHODS	Study candidates ( n = 1500 ) will initially be given an interactive DVD and receive two telephone follow ups at monthly intervals checking on receipt and use of the DVD .\
METHODS	Only those that have increased their physical activity after three months ( n = 600 ) will be randomised into the study .\
METHODS	These participants will receive either a `` mini booster '' ( n = 200 ) , `` full booster '' ( n = 200 ) or no booster ( n = 200 ) .\
METHODS	The `` mini booster '' consists of two telephone calls one month apart to discuss physical activity and maintenance strategies .\
METHODS	The `` full booster '' consists of a face-to-face meeting with the facilitator at the same intervals .\
METHODS	The purpose of these booster sessions is to help the individual maintain their increase in physical activity .\
METHODS	Differences in physical activity , quality of life and costs associated with the booster interventions , will be measured three and nine months from randomisation .\
METHODS	The research will be conducted in 20 of the most deprived neighbourhoods in Sheffield , which have large , ethnically diverse populations , high levels of economic deprivation , low levels of physical activity , poorer health and shorter life expectancy .\
METHODS	Participants will be recruited through general practices and community groups , as well as by postal invitation , to ensure the participation of minority ethnic groups and those with lower levels of literacy .\
METHODS	Sheffield City Council and Primary Care Trust fund a range of facilities and activities to promote physical activity and variations in access to these between neighbourhoods will make it possible to examine whether the effectiveness of the intervention is modified by access to community facilities .\
METHODS	A one-year integrated feasibility study will confirm that recruitment targets are achievable based on a 10 % sample .\
CONCLUSIONS	The choice of study population , study interventions , brief intervention preceding the study , and outcome measure are discussed .\
BACKGROUND	Current Controlled Trials : ISRCTN56495859 ; ClinicalTrials.gov : NCT00836459 .\
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###21788837\
BACKGROUND	Hidradenitis suppurativa is a chronic skin condition characterized by recurrent inflammation and infection of skin in intertriginous areas containing apocrine glands .\
BACKGROUND	Intense pulsed light uses high-energy broad-spectrum light .\
BACKGROUND	Current applications include hair removal and the treatment of acne vulgaris , which has a pathogenesis similar to that of hidradenitis suppurativa .\
BACKGROUND	The authors conducted a study to determine whether intense pulsed light is an effective treatment for hidradenitis suppurativa .\
METHODS	Eighteen patients were randomized to treatment of one axilla , groin , or inframammary area with intense pulsed light two times per week for 4 weeks using a Harmony Laser .\
METHODS	The contralateral side received no treatment and acted as a control .\
METHODS	The response to treatment was assessed using a validated examination and clinical photographs , and by measuring patient satisfaction on a Likert scale .\
RESULTS	After treatment , there was a significant improvement in the mean examination score that was maintained at 12 months ( p < 0.001 , logistical regression analysis ) .\
RESULTS	The improvement was confirmed by independent assessment of clinical photographs ( interrater reliability , 0.79 ; p < 0.001 ) .\
RESULTS	Patients reported high levels of satisfaction with the treatment .\
RESULTS	There was no concurrent improvement on the untreated control side .\
CONCLUSIONS	This small study suggests that intense pulsed light may be an effective treatment for hidradenitis suppurativa .\
CONCLUSIONS	It could be added to treatments used for this condition , particularly for patients keen on avoiding surgery and those with groin and inframammary disease .\
CONCLUSIONS	Further studies are required to confirm the efficacy and mechanism of action of intense pulsed light in hidradenitis suppurativa .\
\
###15119869\
OBJECTIVE	This article compares the cost of mandibular two-implant overdenture treatment to that of conventional denture treatment in an academic teaching hospital .\
METHODS	Sixty edentulous patients ( aged 65 to 75 years ) participated in a randomized clinical trial .\
METHODS	All patients received a new maxillary complete denture and either a mandibular conventional denture ( n = 30 ) or an implant overdenture on two unsplinted implants ( n = 30 ) .\
METHODS	Resource-based microcosting of direct and indirect costs ( eg , expenses and time cost to patients ) of all scheduled and unscheduled visits was conducted through 1 year following delivery of the prostheses .\
RESULTS	Mean direct costs ( 1999 CD dollars ) for scheduled visits in the implant and conventional groups were 2,332 dollars and 814 dollars , respectively , and mean indirect costs were 1,150 dollars and 810 dollars , respectively .\
RESULTS	Differences between the two groups were significant .\
RESULTS	Twenty-six patients in each group had unscheduled visits during the study at a median direct cost for the overdentures of 85 dollars and 64 dollars for the conventional dentures .\
RESULTS	Median indirect costs for unscheduled visits were 163 dollars and 202 dollars , respectively .\
RESULTS	These differences were not significant .\
RESULTS	Mean total costs of the overdentures were 4,245 dollars and 2,316 dollars for the conventional dentures , and the between-group difference was significant .\
CONCLUSIONS	The direct cost of mandibular two-implant overdenture treatment was 2.4 times higher than that of conventional denture treatment .\
CONCLUSIONS	When indirect costs were added , the implant-to-conventional total cost ratio estimate was 1.8 .\
CONCLUSIONS	These cost data can now be combined with estimates of the efficacy of the two types of prosthesis so practitioners and patients can make informed decisions about these prosthodontic treatment concepts .\
\
###11909901\
OBJECTIVE	Antisaccade errors are consistently increased in schizophrenia .\
OBJECTIVE	As they have been demonstrated only in cross sectional studies , it is unclear how they vary longitudinally or with different medications .\
OBJECTIVE	In a previous cross sectional study , we reported a trend towards a reduction in error rates in a patient group treated with risperidone , compared with clozapine and sulpiride treated groups .\
METHODS	Gap random and antisaccade paradigms were performed on two occasions in the same sample of DSM-IV schizophrenic patients ( n = 12 ) in transition between conventional antipsychotic drugs and risperidone .\
METHODS	A cross over design was used with six patients switching from risperidone to conventional ( group I ) and six in the opposite direction ( group II ) .\
METHODS	A control sample ( n = 12 ) was also tested on two occasions and their performance compared .\
METHODS	The effects of practice between first and second testing and of switching between conventional antipsychotic drugs and risperidone and vice versa was also evaluated .\
RESULTS	A significant reduction in error rate was demonstrated during risperidone treatment ( n = 12 ) , compared with conventional APD treatment .\
RESULTS	Switching from conventional to risperidone produced a reduction in errors , and vice versa .\
CONCLUSIONS	Treatment with risperidone was associated with improvement in antisaccade errors .\
\
###12968843\
OBJECTIVE	To assess the efficacy and safety of icodextrin in Japanese patients and to investigate the relationship between net ultrafiltration ( UF ) during the long dwell and plasma oligosaccharides .\
METHODS	Open-labeled clinical trial involving patients on continuous ambulatory peritoneal dialysis ( CAPD ) receiving icodextrin during the 12-hour long dwell for 6 weeks , preceded by and followed by a 2-week baseline period and a follow-up period during which 1.36 % glucose was used for the 8-hour long dwell .\
METHODS	A prospective , randomized multicenter study done in tertiary medical centers .\
METHODS	18 stable patients on CAPD for 3 months or longer .\
METHODS	Net UF ( in milliliters ) , UF rate ( in milliliters per hour ) , plasma oligosaccharides , serum osmolarity ( in milliosmoles per liter ) , peritoneal absorption of icodextrin , and peritoneal clearances of icodextrin , creatinine , and urea were assessed .\
METHODS	Adverse events , laboratory findings , and vital signs were also monitored .\
RESULTS	Long-dwell net UF ( 544.4 + / - 96.7 mL at day 3 , p < 0.001 ; 309.4 + / - 60.7 mL at week 4 , p < 0.001 ; and 391.7 + / - 61.1 mL at week 6 , p < 0.001 ) and UF rate ( 48.2 + / - 38.8 mL / hour at day 3 , p < 0.001 ; 26.9 + / - 22.1 mL/hr at week 4 , p < 0.002 ; and 35.3 + / - 22.9 mL/hr at week 6 , p = 0.0002 ) were significantly greater during the icodextrin period than at baseline ( -25.9 + / - 46.0 mL and -2.2 + / - 22.1 mL/hr , respectively ) .\
RESULTS	Plasma oligosaccharides reached steady state within 2 weeks , remained stable during the treatment period , and returned to baseline level 2 weeks after discontinuation of icodextrin .\
RESULTS	Serum osmolarity increased during the use of icodextrin by approximately 5 mOsm/L .\
RESULTS	No statistically significant relationship was found between plasma oligosaccharides and net UF .\
RESULTS	Peritoneal absorption of icodextrin ( 36.3 % + / - 5.1 % at day 3 , 42.2 % + / - 5.9 % at week 4 , and 38.0 % + / - 6.3 % at week 6 ) and peritoneal clearance of icodextrin ( 10.1 mL/minute at day 3 , 10.1 mL/min at week 4 , and 10.3 mL/min at week 6 ) showed no major change over time .\
RESULTS	Serum sodium and serum chloride both decreased by 5 mEq/L with icodextrin but remained within the normal range during the treatment period and returned to baseline levels immediately after discontinuation .\
RESULTS	No serious adverse events were observed during the study .\
CONCLUSIONS	The results of this study do not support the hypothesis that an increased blood oligosaccharide level and the concomitant elevation in serum osmolarity have a negative impact on peritoneal UF .\
CONCLUSIONS	Therefore , the increase in plasma oligosaccharides appears to be too small to be of clinical significance .\
\
###23754821\
BACKGROUND	Sagittal split ramus osteotomy ( SSRO ) can be associated with postoperative neurosensory disturbances .\
BACKGROUND	This study aimed to evaluate the effectiveness of computer-assisted SSRO in reducing the incidence and severity of neurosensory alterations , using a surgical guide fabricated by computer-aided design and rapid prototyping ( to guide bone cutting lateral to the inferior alveolar nerve ) .\
METHODS	A prospective double-blind , randomized controlled , clinical trial of computer-assisted SSRO vs conventional SSRO ( assigned in a split-mouth design ) in eight patients , mean age 23 ( range 18-30 ) years , who participated in one session preoperatively and three sessions at 1week and 1 , 3 and 6months postoperatively .\
METHODS	At each session , subjective oral sensation was scored and quantitative sensory tests were performed .\
METHODS	Neurosensory changes were compared between the two sides .\
RESULTS	The results showed that on the computer-assisted SSRO sides , patients had lower postoperative abnormal thresholds for the Semmes-Weinstein monofilaments on lower lip and chin ( p < 0.05 at 3months ) and for the two-point discrimination on lower lip ( p < 0.05 at 1week ) and chin ( p < 0.05 at 6months ) , with fewer abnormal self-reported changes in lower lip sensation ( p < 0.05 at 1week ) after surgery .\
CONCLUSIONS	These findings imply that computer-assisted SSRO is associated with better levels of neurosensory function after surgery .\
\
###17437831\
OBJECTIVE	Interstitial cystitis significantly negatively impacts quality of life .\
OBJECTIVE	The demographic and clinical factors associated with decreased quality of life in these patients have not been well studied .\
METHODS	Women with moderate/severe interstitial cystitis enrolled in a clinical trial of intravesical bacillus Calmette-Guerin were studied .\
METHODS	Demographic data and responses to questionnaires were evaluated at baseline , including the O'Leary-Sant Interstitial Cystitis Symptom Index and Problem Index , University of Wisconsin Interstitial Cystitis Inventory , Medical Outcomes Study sexual functioning scale , and the physical composite and mental composite scales of the Medical Outcomes Study Short Form Health Status Survey .\
METHODS	Three composite indexes were constructed ( from the O'Leary-Sant Interstitial Cystitis Symptom Index , O'Leary-Sant Interstitial Cystitis Problem Index , pain/urgency Likert scales and 24-hour voiding diary ) to document the severity , frequency and bother of pain , urinary urgency and frequency ( frequency composite index ) .\
METHODS	Linear and multivariate regression models were used to examine predictors of the physical composite and mental composite scales of the Medical Outcomes Study Short Form Health Status Survey .\
METHODS	Medical Outcomes Study sexual functioning scale data were available for 163 of the 217 women in the trial .\
RESULTS	Physical composite scale ( median 36 ) and mental composite scale ( median 42 ) were lower than the standard population value of 50 .\
RESULTS	Multivariate models showed that employment , pain composite index and Medical Outcomes Study sexual functioning scale ( all p < 0.001 ) predicted physical composite scale , while only Medical Outcomes Study sexual functioning scale ( p < 0.001 ) remained a strong predictor of mental composite scale .\
CONCLUSIONS	Sexual functioning , employment and pain issues predict mental and physical quality of life .\
CONCLUSIONS	In particular , this study identifies sexual functioning as a primary predictor of mental quality of life in women with long-standing interstitial cystitis .\
CONCLUSIONS	It is suggested that sexual functioning may be a salient therapeutic target in the multifaceted treatment of patients with interstitial cystitis .\
\
###19732995\
BACKGROUND	This study analyzed the effectiveness of an individual , delimited , semi-structured reminiscence program as an intervention strategy to reduce depressive symptomatology in a population of Portuguese old people .\
METHODS	A semi-structured reminiscence program was developed in 5 individual sessions .\
METHODS	The program 's impact on depressive symptomatology was tested in 90 subjects aged over 65 years with depressive symptoms , no antidepressive medication , and no signs of dementia .\
METHODS	In a randomized experimental design , participants were assigned to one of 3 groups : a ) experimental group ( exposed to the program ) ; b ) control group , or c ) placebo-control group ( with weekly relaxation sessions ) .\
METHODS	Pre and post-test score differences in Center for Epidemiologic Studies Depression Scale ( CES-D ) ( adapted by Gonalves and Fagulha , 2000-2001 , from the original developed by Radloff , 1977 ) , were analyzed in all participants at the same time intervals .\
RESULTS	In the experimental group , significant improvements were found in depressive symptomatology ( t [ 29 ] = 19.70 , p < 0.01 ) ; the mean values decreased from 39.87 ( standard deviation [ SD ] = 7.90 ) to 13.60 ( SD = 5.14 ) .\
RESULTS	In the control group , a significant increase in depressive symptomatology was observed ( z = -2.83 ; p < 0.001 ) ; the mean values rose from 30.93 ( SD = 7.07 ) to 34.10 ( SD = 8.76 ) .\
RESULTS	In the placebo-control group , depressive symptomatology was reduced ( t [ 29 ] = 2,52 ; p < 0.05 ) from 33.967 ( SD = 7.37 ) to 30.57 ( SD = 9.94 ) , although the difference was less significant than that observed in the experimental group .\
CONCLUSIONS	The results suggest that elaboration of positive and negative autobiographical memories , stimulation of instrumental and integrative reminiscences and narration of specific and positive autobiographical memories using the reminiscence program , as designed and analyzed in this study , may be a tool for psychological intervention to reduce depressive symptomatology in old age .\
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###22575312\
OBJECTIVE	The study sought to determine whether rapid access to medical care and reperfusion results in a better prognosis in patients with in-hospital compared with out-of-hospital stent thrombosis ( ST ) in patients with ST-segment elevation myocardial infarction ( STEMI ) in the HORIZONS-AMI ( Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction ) trial .\
BACKGROUND	Whether the prognosis of in-hospital and out-of-hospital ST are similar is uncertain , with conflicting data reported from prior studies .\
METHODS	A total of 3,602 STEMI patients undergoing primary percutaneous coronary intervention ( PCI ) were randomized to bivalirudin ( n = 1,800 ) versus unfractionated heparin ( UFH ) plus a glycoprotein IIb/IIIa inhibitor ( GPI ) ( UFH+GPI ; n = 1,802 ) .\
METHODS	Stents were implanted in 3,202 patients , 156 ( 4.9 % ) of whom developed Academic Research Consortium definite/probable ST during 3-year follow-up .\
METHODS	We investigated the 1-year clinical outcomes after ST in 54 patients with in-hospital ST compared with 102 patients with out-of-hospital ST.\
RESULTS	One year after the ST event , patients with in-hospital compared with out-of-hospital ST had significantly greater mortality ( 27.8 % vs. 10.8 % , p < 0.01 ) ; most deaths in both groups occurred within 1 week of the ST event .\
RESULTS	Patients with in-hospital ST also had higher rates of major bleeding ( 21.2 % vs. 6.0 % , p < 0.01 ) , but a lower rate of myocardial infarction ( 56.6 % vs. 77.5 % , p < 0.01 ) .\
RESULTS	Subgroup analysis within both in-hospital and out-of-hospital ST groups indicated that subacute ST had the highest mortality .\
RESULTS	By multivariable analysis , 1-year mortality was significantly increased in patients with in-hospital compared with out-of-hospital ST ( adjusted hazard ratio : 4.62 , 95 % confidence interval : 1.98 to 10.77 , p < 0.01 ) .\
RESULTS	Additional correlates of increased mortality after an ST event included diabetes and randomization to UFH+GPI ( vs. bivalirudin ) .\
CONCLUSIONS	Following primary PCI for STEMI , more than one-third of all ST events during 3-year follow-up occurred during the index hospital phase .\
CONCLUSIONS	Mortality and major bleeding were significantly higher after in-hospital ST compared with out-of-hospital ST. ( Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction ; NCT00433966 ) .\
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###9797854\
OBJECTIVE	The endocrine manifestation of puberty , nocturnal pulsatile secretion of gonadotrophins precedes the physical manifestations by 2 years .\
OBJECTIVE	Whether gonadal steroids and inhibin have a role to play in the regulation of pulsatile gonadotrophin release is unclear .\
OBJECTIVE	The agonadal model , girls with Turner 's syndrome ( TS ) , has been used to determine the role of the hypothalamic pulse generator in the ontogeny of gonadotrophin secretion in man .\
OBJECTIVE	We evaluated the ontogeny of gonadotrophin secretion in TS girls with respect to amplitude and frequency and compared these results to those obtained in a group of normal girls .\
OBJECTIVE	The effects of treatment with ethinyloestradiol ( EE2 ) or oxandrolone ( OX ) on parameters of gonadotrophin secretion were also evaluated .\
METHODS	We studied 32 girls with TS , aged 4.3-12 .4 years .\
METHODS	All were prepubertal at the start of the study and longterm follow up revealed that none entered spontaneous puberty .\
METHODS	The pulse amplitude and frequency was evaluated and compared to the results obtained in 23 normal girls , aged 4.9-12 .8 years who acted as controls .\
METHODS	Samples were taken at 20 minute intervals for 24 h for the measurement of serum concentrations of luteinising ( LH ) and follicle stimulating ( FSH ) hormones .\
METHODS	The girls were than randomized to receive EE2 or OX and were then re-admitted 6 months into the course of the treatment for a repeat 24 h serum profile of LH and FSH levels .\
RESULTS	The girls with TS showed a clearly defined dominant pulse periodicity of 180 min and that in the normal cohort was 160-220 min .\
RESULTS	The girls with TS had an increased oscillatory activity between 120 and 260 min compared to the normal .\
RESULTS	Mean 24 h serum gonadotrophin concentration in TS girls was always higher than in the normal cohort .\
RESULTS	The inflection points of the fitted polynomial regression equation relating sex hormone concentration with age was similar for the two groups .\
RESULTS	EE2 lead to a significant change in pulse periodicity in TS girls but OX had no significant effect on the pulse periodicity .\
CONCLUSIONS	These results demonstrate that girls with Turner syndrome have gonadotrophin pulse periodicity in the prepubertal years similar to those of normal girls .\
CONCLUSIONS	The oscillatory activity was much greater in girls with Turner syndrome at all ages in the prepubertal years , suggesting a role for the ovary in modulating gonadotrophin secretion in the prepubertal years .\
CONCLUSIONS	Our data confirm that in girls with Turner syndrome the normal pattern of gonadotrophin secretion evolving with time is preserved .\
\
###24343275\
BACKGROUND	Microencapsulated sodium butyrate ( MSB ) has been previously associated with anti-inflammatory and regenerative properties regarding large bowel mucosa .\
BACKGROUND	We aimed to examine a role of MSB in patients with diverticulosis , hypothesizing its potential for reduction of diverticulitis episodes and diverticulitis prevention .\
METHODS	Seventy-three patients with diverticulosis ( diagnosed in colonoscopy or/and barium enema or/and CT colography ) were recruited for the study and randomized .\
METHODS	The investigated group was administered MSB 300 mg daily ; the control group was administered placebo .\
METHODS	After 12 months , a total of 52 patients completed the study and were subject to analysis ( 30 subjects and 22 controls ) .\
METHODS	During the study , the number of episodes of diverticulitis ( symptomatic diagnosis with acute pain , fever , and leukocytosis ) , hospitalizations , and surgery performed for diverticulitis were recorded .\
METHODS	Additionally , a question regarding subjective improvement of symptoms reflected changes in quality of life during the analysis .\
RESULTS	After 12 months , the study group noted a significantly decreased number of diverticulitis episodes in comparison to the control group .\
RESULTS	The subjective quality of life in the study group was higher than in the control group .\
RESULTS	There were no side effects of the MSB during the therapy .\
CONCLUSIONS	MSB reduces the frequency of diverticulitis episodes , is safe , and improves the quality of life .\
CONCLUSIONS	It can play a role in the prevention of diverticulitis .\
\
###20083429\
OBJECTIVE	We sought to determine the clinical implications , predictors and patterns of residual sleep apnea on continuous positive airway pressure ( CPAP ) treatment in patients with moderate-to-severe obstructive sleep apnea ( OSA ) .\
METHODS	We performed a post hoc secondary analysis of data from a previously reported randomized trial .\
METHODS	Sleepy patients with a high risk of moderate-to-severe OSA identified by a diagnostic algorithm were randomly assigned to standard CPAP titration during polysomnography ( PSG ) or ambulatory titration using auto-CPAP and home sleep testing .\
METHODS	We observed them for 3 months and measured apnea-hypopnea index ( AHI ) on CPAP , Epworth sleepiness scale ( ESS ) , sleep apnea quality of life index ( SAQLI ) , CPAP pressure and objective CPAP compliance .\
RESULTS	Sixty-one patients were randomized , 30 to the PSG group and 31 to the ambulatory group .\
RESULTS	Fifteen patients ( 25 % ) had residual sleep apnea ( AHI > 10/h on CPAP ) with similar proportions in the PSG ( 7/30 ) and ambulatory ( 8/31 ) groups .\
RESULTS	Baseline variables including age , body mass index ( BMI ) , ESS , SAQLI , respiratory disturbance index ( RDI ) and CPAP pressure did not differ between the groups .\
RESULTS	Outcomes including compliance were worse in patients with residual sleep apnea .\
RESULTS	Periodic breathing was prevalent among patients with residual sleep apnea .\
CONCLUSIONS	Residual sleep apnea is common in patients with moderate-to-severe OSA , despite careful CPAP titration , and is associated with worse outcomes .\
\
###12095015\
OBJECTIVE	This prospective , randomized , double-blinded study was designed to compare the effects of remifentanil or fentanyl on anaesthetic induction characteristics of propofol , thiopental or etomidate .\
METHODS	Seventy-two patients were enrolled in six groups of 12 individuals each .\
METHODS	In three groups , fentanyl was given as a bolus dose of 1.5 microg kg ( -1 ) , whereas the others received a remifentanil infusion at 0.5 microg kg ( -1 ) min ( -1 ) .\
METHODS	Five minutes later , propofol , thiopental or etomidate were titrated to a state of unresponsiveness .\
METHODS	Assessment included the amounts of drug necessary for induction , haemodynamics and the times to apnoea , loss of eyelash reflex , and the release of a water-filled syringe held in the patient 's hand .\
RESULTS	Induction times to loss of the eyelash reflex were significantly shorter in the remifentanil than in the fentanyl groups : with propofol 50.7 + / - 13.6 s ( mean + / - SD ) versus 74.9 + / - 27.0 s ( P < 0.01 ) , with thiopental 42.9 + / - 16.8 s versus 77.2 + / - 27.8 s ( P < 0.01 ) and with etomidate 54.7 + / - 17.6 s versus 72.3 + / - 24.0 s ( P < 0.05 ) .\
RESULTS	The times to respiratory arrest or for the syringe to fall were significantly shorter with remifentanil than with fentanyl for propofol and for thiopental , but not for etomidate .\
RESULTS	In terms of dosages per kg body weight necessary to achieve unresponsiveness , less propofol ( -29 % , P < 0.05 ) , thiopental ( -25 % , P < 0.05 ) or etomidate ( -32 % , P < 0.01 ) was necessary with remifentanil than with fentanyl .\
RESULTS	Haemodynamic responses to tracheal intubation were controlled more effectively with remifentanil .\
RESULTS	However , within the remifentanil groups , mean arterial pressure significantly decreased during induction : -26 % with propofol , -181 % with thiopental and -14 % with etomidate ( all P < 0.01 ) .\
CONCLUSIONS	During anaesthetic induction , a remifentanil infusion of 0.5 microg kg ( -1 ) min ( -1 ) over 5 min is a suitable alternative to a 1.5 microg kg ( -1 ) bolus dose of fentanyl : induction times are shorter with reduced amounts of propofol , thiopental or etomidate .\
\
###19485973\
BACKGROUND	Heavy drinking may increase blood glucose levels .\
BACKGROUND	Moreover , in alcohol-dependent subjects , glucose may play a putative role in alcohol preference .\
METHODS	This study investigated the relationship between blood glucose levels and both alcohol heavy drinking and craving in alcohol-dependent subjects participating in the COMBINE Study .\
METHODS	The primary objective was to evaluate the relationship between baseline ( pretreatment ) glucose levels and percentage of heavy drinking day ( PHDD ) during treatment .\
METHODS	The secondary objective was to evaluate the relationship between glucose levels , baseline PHDD , and craving measured by the Obsessive Compulsive Drinking Scale ( OCDS ) .\
RESULTS	This analysis consisted of 1,324 participants .\
RESULTS	Baseline glucose levels were significantly and positively associated with PHDD during treatment [ F ( 1 , 1225 ) = 5.21 , p = 0.023 ] , after controlling for baseline PHDD [ F ( 1 , 1225 ) = 36.25 , p < 0.0001 ] , gender [ F ( 1 , 1225 ) = 3.33 , p = 0.07 ] , and body mass index ( BMI ) [ F ( 1 , 1225 ) = 0.31 , p = 0.58 ] .\
RESULTS	Higher glucose levels at baseline were associated with a higher percentage of PHDD at pretreatment [ F ( 1 , 1304 ) = 5.96 , p = 0.015 ] , after controlling for gender [ F ( 1 , 1304 ) = 0.29 , p = 0.59 ] and BMI [ F ( 1 , 1304 ) = 0.90 , p = 0.34 ] .\
RESULTS	Glucose was not significantly associated with the OCDS total score [ F ( 1 , 1304 ) = 0.12 , p = 0.73 ] , the OCDS Obsessive subscale [ F ( 1 , 1304 ) = 0.35 , p = 0.56 ] , or the OCDS Compulsive subscale [ F ( 1 , 1304 ) = 1.19 , p = 0.28 ] scores , after controlling for gender and BMI .\
CONCLUSIONS	A link between pretreatment glucose levels and heavy drinking during treatment was found , suggesting a role of glucose in predicting heavy alcohol consumption .\
CONCLUSIONS	Although caution is needed in the interpretation of these results , elevated glucose and heavy drinking may be affected by a common mechanism and manipulations affecting glucose regulation may influence alcohol consumption .\
\
###19962270\
BACKGROUND	To look at wound complications with either a transverse or vertical groin incision in vascular surgery .\
METHODS	All patients undergoing vascular procedure requiring access to femoral vessels were randomized to either a vertical or transverse incision .\
METHODS	Patients were followed up for 28 days after the procedure and examined for wound infection , wound breakdown , development of lymphatic leak and lymphatic collection .\
RESULTS	88 patients ( 116 groins ) were randomised to either incision .\
RESULTS	Of these , 55 groins had transverse incisions and the remaining had vertical incisions .\
RESULTS	There was no significant difference in the patient 's age , sex , smoking , diabetes , operative times and use of prosthetic material .\
RESULTS	29/61 ( 47.5 % ) of vertical incisions and 7/55 ( 12.7 % ) of transverse incisions had wound complications ( p < 0.001 ) .\
RESULTS	There were 13 ( 11 % ) wound infections in the 116 groins by day 28 .\
RESULTS	There were 3 wound infections in the transverse group and 10 infections in the vertical group ( p = 0.062 ) .\
RESULTS	There were 17 ( 27.9 % ) lymphatic leaks in the vertical incisions compared to 7 ( 12.7 % ) in the transverse incisions ( p = 0.044 ) .\
RESULTS	The majority of infections were diagnosed after patient discharge from hospital .\
CONCLUSIONS	Wound complications are higher with vertical incision .\
CONCLUSIONS	Many infections are diagnosed after patient discharge .\
CONCLUSIONS	We recommend transverse incisions for access to the femoral vessels in the groin .\
\
###24207098\
OBJECTIVE	Thrombolysis with tissue plasminogen activator is proven to reduce disability when given within 45h of ischemic stroke onset .\
OBJECTIVE	However , tissue plasminogen activator only succeeds in recanalizing large vessel arterial occlusion in a minority of patients .\
OBJECTIVE	We hypothesized that anterior circulation ischemic stroke patients , selected with ` dual target ' vessel occlusion and evidence of salvageable brain using computed tomography or magnetic resonance imaging ` mismatch ' within 45h of onset , would have improved reperfusion and early neurological improvement when treated with intra-arterial clot retrieval after intravenous tissue plasminogen activator compared with intravenous tissue plasminogen activator alone .\
METHODS	EXTEND-IA is an investigator-initiated , phase II , multicenter prospective , randomized , open-label , blinded-endpoint study .\
METHODS	Ischemic stroke patients receiving standard 09mg/kg intravenous tissue plasminogen activator within 45h of stroke onset who have good prestroke functional status ( modified Rankin Scale < 2 , no upper age limit ) will undergo multimodal computed tomography or magnetic resonance imaging .\
METHODS	Patients who also meet dual target imaging criteria : vessel occlusion ( internal carotid or middle cerebral artery ) and mismatch ( perfusion lesion : ischemic core mismatch ratio > 12 , absolute mismatch > 10ml , ischemic core volume < 70ml ) will be randomized to either clot retrieval with the Solitaire FR device after full dose intravenous tissue plasminogen activator , or tissue plasminogen activator alone .\
RESULTS	The coprimary outcome measure will be reperfusion at 24h and favorable clinical response ( reduction in National Institutes of Health Stroke Scale by 8 points or reaching 0-1 ) at day 3 .\
RESULTS	Secondary outcomes include modified Rankin Scale at day 90 , death , and symptomatic intracranial hemorrhage .\
\
###8518245\
OBJECTIVE	To investigate the effects of two doses of transdermally applied oestradiol on lipid and lipoprotein metabolism in climacteric women .\
METHODS	A randomised double blind cross-over comparison .\
METHODS	Departments of Obstetrics and Gynaecology , Ostra and Sahlgren 's Hospital , Gteborg and Karolinska Hospital , Stockholm , Sweden .\
METHODS	Fifty-two women with climacteric symptoms were treated with oestradiol transdermally applied ( 50 micrograms and 100 micrograms/24 h ) .\
METHODS	A daily dose of 5 mg oral medroxyprogesterone acetate was added 14 days each treatment cycle of four weeks .\
METHODS	Blood samples were drawn after an overnight fast before and after four and eight months of treatment .\
METHODS	Assays for serum triglycerides and cholesterol as well as low density lipoprotein ( LDL ) and high density lipoprotein ( HDL ) cholesterol including the subfractions HDL2 and HDL3 were performed .\
RESULTS	Significant decrements were found in triglycerides and serum and LDL cholesterol during treatment with both doses .\
RESULTS	A modest rise in HDL2 cholesterol was observed after treatment with the 100 micrograms/24 h dose .\
CONCLUSIONS	The serum lipid and lipoprotein profile encountered in these women was similar to that reported with oral formulations except for a decrease in triglycerides .\
CONCLUSIONS	The metabolic differences between the two doses of transdermal oestradiol is probably of minor clinical significance in normal postmenopausal women .\
\
###26017057\
OBJECTIVE	The metastatic status of regional lymph nodes is the most relevant prognostic factor in breast cancer , melanoma , and other solid organ tumors with a lymphatic spread .\
OBJECTIVE	The current gold standard for detection and targeted excision of the sentinel lymph node is preoperative lymphoscintigraphy with technetium Tc 99m .\
OBJECTIVE	Because of the worldwide shortage of technetium Tc 99m , physicians are looking for nonradioactive dyes for sentinel lymph node labeling .\
OBJECTIVE	Based on several retrospective studies , the fluorescent dye indocyanine green is considered a possible alternative to technetium Tc 99m .\
OBJECTIVE	To analyze the feasibility and clinical benefit of intraoperative near infrared fluorescence sentinel lymph node excision ( SLNE ) compared with standard technetium Tc 99m-guided SLNE using malignant melanoma in which SLNE is firmly established .\
METHODS	Analysis of a prospective clinical trial at the Skin Cancer Center , University Hospital Essen .\
METHODS	Eighty patients with malignant melanoma on the trunk or extremities ( upper and lower ) who were scheduled to undergo SLNE were included in this study from January 1 , 2013 , to June 27 , 2014 .\
METHODS	Concordance of preoperative and intraoperative sentinel lymph node detection rates .\
RESULTS	During the study period , 80 patients were operated on with an additional intraoperative application of a near infrared fluorescent dye .\
RESULTS	In these 80 surgical procedures , 147 SLNs were excised .\
RESULTS	Detection of a technetium Tc 99m-marked SLN before surgery was possible in all cases .\
RESULTS	Intraoperative visualization of the SLN by indocyanine green before skin incision was successful in only 17 of 80 patients ( 21 % ) .\
RESULTS	The number of SLNs identified using the near infrared fluorescence technique in the operative site after skin incision and initial tissue preparation was 141 of 147 ( 96 % ) .\
CONCLUSIONS	Among patients in whom the lymph node basin can not be predicted correctly ( eg , in cutaneous melanoma on the trunk ) , the use of indocyanine green for SLN detection is severely limited compared with SLNE using standard technique guided by technetium Tc 99m .\
CONCLUSIONS	Therefore , SLNE with the use of radiocolloid , followed if possible by single-photon emission computed tomography , remains the gold standard .\
BACKGROUND	German Clinical Trials Register identifier DRKS00004619 .\
\
###16096286\
OBJECTIVE	To evaluate the efficacy of the Lidcombe programme of early stuttering intervention by comparison to a control group .\
METHODS	A pragmatic , open plan , parallel group , randomised controlled trial with blinded outcome assessment .\
METHODS	Two public speech clinics in New Zealand .\
METHODS	Stuttering preschool children who presented to the speech clinics for treatment .\
METHODS	Inclusion criteria were age 3-6 years and frequency of stuttering of at least 2 % syllables stuttered .\
METHODS	Exclusion criteria were onset of stuttering during the six months before recruitment and treatment for stuttering during the previous 12 months .\
METHODS	54 participants were randomised : 29 to the Lidcombe programme arm and 25 to the control arm .\
METHODS	12 of the participants were girls .\
METHODS	Lidcombe programme of early stuttering intervention .\
METHODS	Frequency of stuttering was measured as the proportion of syllables stuttered , from audiotaped recordings of participants ' conversational speech outside the clinic .\
METHODS	Parents in both arms of the trial collected speech samples in three different speaking situations before randomisation and at three , six , and nine months after randomisation .\
RESULTS	Analysis showed a highly significant difference ( P = 0.003 ) at nine months after randomisation .\
RESULTS	The mean proportion of syllables stuttered at nine months after randomisation was 1.5 % ( SD 1.4 ) for the treatment arm and 3.9 % ( SD 3.5 ) for the control arm , giving an effect size of 2.3 % of syllables stuttered ( 95 % confidence interval 0.8 to 3.9 ) .\
RESULTS	This effect size was more than double the minimum clinically worthwhile difference specified in the trial protocol .\
CONCLUSIONS	The results provide evidence from a randomised controlled trial to support early intervention for stuttering .\
CONCLUSIONS	The Lidcombe programme is an efficacious treatment for stuttering in children of preschool age .\
\
###17507703\
BACKGROUND	Treatment guidelines recommend the regular use of inhaled corticosteroids for patients with mild persistent asthma .\
BACKGROUND	We investigated whether the symptom-driven use of a combination of beclomethasone dipropionate and albuterol ( also known as salbutamol ) in a single inhaler would be as effective as the regular use of inhaled beclomethasone and superior to the as-needed use of inhaled albuterol .\
METHODS	We conducted a 6-month , double-blind , double-dummy , randomized , parallel-group trial .\
METHODS	After a 4-week run-in , patients with mild asthma were randomly assigned to receive one of four inhaled treatments : placebo twice daily plus 250 microg of beclomethasone and 100 microg of albuterol in a single inhaler as needed ( as-needed combination therapy ) ; placebo twice daily plus 100 microg of albuterol as needed ( as-needed albuterol therapy ) ; 250 microg of beclomethasone twice daily and 100 microg of albuterol as needed ( regular beclomethasone therapy ) ; or 250 microg of beclomethasone and 100 microg of albuterol in a single inhaler twice daily plus 100 microg of albuterol as needed ( regular combination therapy ) .\
METHODS	The primary outcome was the morning peak expiratory flow rate .\
RESULTS	In 455 patients with mild asthma who had a forced expiratory volume in 1 second of 2.96 liters ( 88.36 % of the predicted value ) , the morning peak expiratory flow rate during the last 2 weeks of the 6-month treatment was higher ( P = 0.04 ) and the number of exacerbations during the 6-month treatment was lower ( P = 0.002 ) in the as-needed combination therapy group than in the as-needed albuterol therapy group , but the values in the as-needed combination therapy group were not significantly different from those in the groups receiving regular beclomethasone therapy or regular combination therapy .\
RESULTS	The cumulative dose of inhaled beclomethasone was lower in the as-needed combination therapy group than in the groups receiving regular beclomethasone therapy or regular combination therapy ( P < 0.001 for both comparisons ) .\
CONCLUSIONS	In patients with mild asthma , the symptom-driven use of inhaled beclomethasone ( 250 microg ) and albuterol ( 100 microg ) in a single inhaler is as effective as regular use of inhaled beclomethasone ( 250 microg twice daily ) and is associated with a lower 6-month cumulative dose of the inhaled corticosteroid .\
CONCLUSIONS	( ClinicalTrials.gov number , NCT00382889 [ ClinicalTrials.gov ] . )\
\
###24989152\
OBJECTIVE	There is a paucity of controlled treatment trials for the treatment of conversion disorder , seizures type , also known as psychogenic nonepileptic seizures ( PNES ) .\
OBJECTIVE	Psychogenic nonepileptic seizures , the most common conversion disorder , are as disabling as epilepsy and are not adequately addressed or treated by mental health clinicians .\
OBJECTIVE	To evaluate different PNES treatments compared with standard medical care ( treatment as usual ) .\
METHODS	Pilot randomized clinical trial at 3 academic medical centers with mental health clinicians trained to administer psychotherapy or psychopharmacology to outpatients with PNES .\
METHODS	Thirty-eight participants were randomized in a blocked schedule among 3 sites to 1 of 4 treatment arms and were followed up for 16 weeks between September 2008 and February 2012 ; 34 were included in the analysis .\
METHODS	Medication ( flexible-dose sertraline hydrochloride ) only , cognitive behavioral therapy informed psychotherapy ( CBT-ip ) only , CBT-ip with medication ( sertraline ) , or treatment as usual .\
METHODS	Seizure frequency was the primary outcome ; psychosocial and functioning measures , including psychiatric symptoms , social interactions , quality of life , and global functioning , were secondary outcomes .\
METHODS	Data were collected prospectively , weekly , and with baseline , week 2 , midpoint ( week 8 ) , and exit ( week 16 ) batteries .\
METHODS	Within-group analyses for each arm were performed on primary ( seizure frequency ) and secondary outcomes from treatment-blinded raters using an intention-to-treat analysis .\
RESULTS	The psychotherapy ( CBT-ip ) arm showed a 51.4 % seizure reduction ( P = .01 ) and significant improvement from baseline in secondary measures including depression , anxiety , quality of life , and global functioning ( P < .001 ) .\
RESULTS	The combined arm ( CBT-ip with sertraline ) showed 59.3 % seizure reduction ( P = .008 ) and significant improvements in some secondary measures , including global functioning ( P = .007 ) .\
RESULTS	The sertraline-only arm did not show a reduction in seizures ( P = .08 ) .\
RESULTS	The treatment as usual group showed no significant seizure reduction or improvement in secondary outcome measures ( P = .19 ) .\
CONCLUSIONS	This pilot randomized clinical trial for PNES revealed significant seizure reduction and improved comorbid symptoms and global functioning with CBT-ip for PNES without and with sertraline .\
CONCLUSIONS	There were no improvements in the sertraline-only or treatment-as-usual arms .\
CONCLUSIONS	This study supports the use of manualized psychotherapy for PNES and successful training of mental health clinicians in the treatment .\
CONCLUSIONS	Future studies could assess larger-scale intervention dissemination .\
BACKGROUND	clinicaltrials.gov Identifier : NCT00835627 .\
\
###24311014\
OBJECTIVE	To prospectively assess the added value of gadolinium-enhanced and diffusion-weighted ( DWI ) MRI for the diagnosis of pelvic recurrence from colorectal cancer ( CRC ) .\
METHODS	Fifty-two patients with suspected pelvic recurrence from CRC underwent pelvic MRI with T2-weighted ( `` T2 '' ) , gadolinium-enhanced fat-suppressed T1-weighted ( `` gadolinium '' ) and DWI MR sequences .\
METHODS	Three readers ( senior radiologist : R1 , two residents : R2 , R3 ) scored the likelihood of recurrence on `` T2 , '' `` T2 + DWI , '' and `` T2 + Gadolinium . ''\
RESULTS	Twenty-seven patients had 42 sites of pelvic recurrence .\
RESULTS	On `` T2 , '' R1 achieved AUC of .95 , sensitivity 88.4 % , specificity 95.2 % .\
RESULTS	For R2 , these figures were .89 , 81.4 % , 90.5 % , for R3 .90 , 83.7 % , 76 % .\
RESULTS	Both Gadolinium injection and DWI significantly improved AUCs for residents but not for the senior radiologist : up to .988 ( R2 , P = 0.006 ) and to .98 ( R3 , P = 0.01 ) with DWI and to .96 ( R2 , P = 0.04 ) , .98 ( R3 , P = 0.01 ) after gadolinium .\
RESULTS	All readers achieved slightly better AUCs with `` T2 + DWI '' than with `` T2 + Gadolinium '' but not significantly ( P = 0.68 , P = 0.11 , P = 0.3 ; respectively ) .\
CONCLUSIONS	For diagnosis of pelvic recurrence from CRC , both DWI and gadolinium-enhanced MRI significantly increase diagnostic performances compared with `` T2 '' MRI for residents .\
CONCLUSIONS	DWI may be helpful in patients with contra-indications to intravenous administration of gadolinium .\
\
###20360491\
BACKGROUND	Digital nerve blocks ( DNB ) are performed frequently in the Emergency Department ( ED ) .\
BACKGROUND	The aim of this study was to establish whether single injection subcutaneous digital nerve block ( SDNB ) is as effective as the traditional ( two injection ) digital nerve block ( TDNB ) for digital anaesthesia .\
METHODS	Single blinded , prospective , randomised-controlled multicentre trial within Hampshire EDs .\
METHODS	Patients > or = 16 years attending the ED with fingertip injuries/infections ( distal to the distal-interphalangeal joint ) requiring a DNB were randomised to SDNB/TDNB groups .\
METHODS	Outcome measures were : primary - successful anaesthesia ; secondary - patient distress , clinician satisfaction ( CS ) , complications .\
RESULTS	76 patients were randomised .\
RESULTS	( 37 received SDNB ) .\
RESULTS	At 5 min , more patients in the SDNB group ( 28/37 , 76 % ) were adequately anaesthetised than in the TDNB group , ( 22/34 , 65 % ) .\
RESULTS	At 10 min , 33/37 ( 89 % ) of the SDNB group compared to 28/34 ( 82 % ) of the TDNB group were adequately anaesthetised .\
RESULTS	The mean ( SD ) of self-reported distress scores for the SDNB group were lower than those reported for the TDNB group , whereas the mean ( SD ) of CS scores for SDNB were higher than those reported for TDNB .\
RESULTS	Neither group reported complications from anaesthesia .\
CONCLUSIONS	SDNB is as effective as TDNB .\
CONCLUSIONS	Outcome measures favoured SDNB , but only CS scores achieved statistical significance .\
CONCLUSIONS	Trial recruitment is much slower than anticipated .\
CONCLUSIONS	However , clinical practice has demonstrated that SDNB works and practice is already changing within the Hampshire region , with some departments adopting SDNB as standard practice .\
CONCLUSIONS	Therefore , the results are being presented now to allow clinicians to make an informed choice .\
CONCLUSIONS	Our results may also contribute to future metanalyses .\
\
###17616788\
BACKGROUND	Low-energy fractures of the hip , forearm , shoulder , and spine are known consequences of osteoporosis .\
OBJECTIVE	We evaluated the effect of 1 y of treatment with calcium and vitamin D on bone mineral density ( BMD ) and bone markers in patients with a recent low-energy fracture .\
METHODS	In a double-blinded design , patients with fracture of the hip ( lower-extremity fracture , or LEF ) or upper extremity ( UEF ) were randomly assigned to receive 3000 mg calcium carbonate + 1400 IU cholecalciferol or placebo ( 200 IU cholecalciferol ) .\
METHODS	BMD of the hip ( HBMD ) and lumbar spine ( LBMD ) were evaluated by dual-energy X-ray absorptiometry , and physical performance was assessed by the timed Up & Go test .\
METHODS	Serum concentrations of 25-hydroxycholecalciferol , parathyroid hormone ( PTH ) , telepeptide of type I collagen ( ICTP ) , osteocalcin , and N-terminal propeptide of collagen type I were measured .\
RESULTS	A total of 122 patients were included ( 84 % women ; x + / - SD age : 70 + / - 11 y ) ; 68 % completed the study .\
RESULTS	In an intention-to-treat analysis , LBMD increased in the intervention group and decreased in the placebo group , and the difference between the groups was significant after 12 mo : 0.931 + / - 0.211 compared with 0.848 + / - 0.194 ( P < 0.05 ) .\
RESULTS	No significant change was shown for HBMD .\
RESULTS	The effect of treatment was more pronounced in patients aged < 70 y.\
RESULTS	The intervention decreased bone turnover .\
RESULTS	PTH was significantly lower in the intervention group ( P < 0.01 ) for the LEF patients .\
RESULTS	ICTP and change in LBMD were significantly related to physical performance .\
CONCLUSIONS	A 1-y intervention with calcium and vitamin D reduced bone turnover , significantly increased BMD in patients younger than 70 y , and decreased bone loss in older patients .\
CONCLUSIONS	The effect of treatment was related to physical performance .\
\
###12195057\
METHODS	A prospective randomized study was conducted .\
OBJECTIVE	To determine whether the use of a cervical carbon fiber intervertebral fusion cage improves the outcome of anterior cervical decompression and fusion , as compared with the Cloward procedure using autograft .\
BACKGROUND	Despite the theoretical advantages of using intervertebral cages , including reduced donor site morbidity and prevention of graft collapse , an improved clinical outcome has not yet been documented .\
METHODS	For this study , 103 patients were randomized to anterior cervical decompression and fusion with a carbon fiber intervertebral fusion cage ( n = 52 ) or the Cloward procedure ( n = 51 ) .\
METHODS	An independent observer quantified pain and functional disability .\
METHODS	Fusion rate , segmental kyphosis , and disc height were assessed by radiographs .\
RESULTS	During a mean follow-up period of 36 months ( range , 24-72 months ) for 89 patients ( 86 % ) , the pain and disability were similar for both treatments .\
RESULTS	Postoperative donor site pain was significantly less in the carbon fiber intervertebral fusion cage group .\
RESULTS	The fusion rate was 86 % in the Cloward procedure group and 62 % in the carbon fiber intervertebral fusion cage group ( P < 0.05 ) .\
RESULTS	In the latter group , patients with pseudarthrosis reported more severe pain than fused patients ( 51 and 33 visual analog scores , respectively ) , but the difference was not significant .\
RESULTS	The segmental kyphosis was less and the disc height increased in the carbon fiber intervertebral fusion cage group , as compared with the Cloward procedure group .\
RESULTS	Disc height was not correlated with outcome .\
RESULTS	Segmental kyphosis showed a weak ( r = -0.3 ) but significant ( P < 0.05 ) correlation with improvement of the Cervical Spine Functional Score , but not with other outcome variables .\
CONCLUSIONS	Except for reduced donor site pain , the clinical outcome for the carbon fiber intervertebral fusion cage is the same as for the Cloward procedure .\
CONCLUSIONS	Use of the cage results in a more lordotic alignment and an increased disc height , but in a higher pseudarthrosis rate than use of the Cloward procedure .\
\
###19114224\
BACKGROUND	Guggul , herbal extract from resin of the Commiphora mukul tree , is widely used in Asia as a cholesterol-lowering agent based on Indian Ayurvedic medicine .\
BACKGROUND	Its popularity for this use is increasing in the US and Western Europe .\
BACKGROUND	Guggulsterones , the presumed bioactive compounds of guggul , may antagonise two nuclear hormone receptors involved in cholesterol metabolism , which is a possible explanation for hypolipidemic effects of these extracts .\
BACKGROUND	However , publications of efficacy data on the use of guggul extracts in Western populations are scarce .\
OBJECTIVE	To study the efficacy of a guggul-based formulation ( short : guggul ) on blood lipids in healthy adults with moderately increased cholesterol .\
METHODS	Double-blind , randomised , placebo controlled trial in Norwegian general practice .\
METHODS	43 women and men , age 27-70 , with moderately increased cholesterol , randomised to use 2160mg guggul ( 4 capsules ) daily , or placebo for 12 weeks .\
METHODS	Mean change in total cholesterol , low-density lipoprotein cholesterol ( LDL-C ) , triglycerides , high-density lipoprotein cholesterol ( HDL-C ) and total cholesterol/HDL-C ratio compared with baseline .\
METHODS	Lipids were analysed at baseline , and at 6 and 12 weeks .\
METHODS	In addition , unexpected events and adverse effects were recorded .\
RESULTS	Two dropouts , one withdrawal , and incomplete lab results for six persons left 34 participants to accomplish the trial ( 18-guggul , 16-placebo ) with complete lab test data .\
RESULTS	After 12 weeks , mean levels of total cholesterol and HDL-C in the active group were significantly reduced compared with the placebo group .\
RESULTS	However , the mean levels of LDL-C , triglycerides , and total cholesterol/HDL-C ratio between the two groups did not change significantly .\
RESULTS	Ten guggul users ( vs. four in the placebo group ) reported side effects : mild gastrointestinal discomfort ( n = 7 ) , possible thyroid problems ( n = 2 ) , and generalized skin rash ( n = 1 ) .\
RESULTS	The latter resulted in withdrawal from trial .\
CONCLUSIONS	Even if total cholesterol and HDL-C were significantly reduced , the clinical magnitude of this remains obscure .\
CONCLUSIONS	More and larger studies are needed to establish effects and safety of guggul-based formulations in the treatment for hypercholesterolemia .\
\
###11483325\
OBJECTIVE	To demonstrate the efficacy of radiochemotherapy ( RCT ) as the first choice of treatment for advanced unresectable head-and-neck cancer .\
OBJECTIVE	To prove an expected benefit of simultaneously given chemotherapy , a two-arm randomized study with hyperfractionated accelerated radiochemotherapy ( HF-ACC-RCT ) vs. hyperfractionated accelerated radiotherapy ( HF-ACC-RT ) was initiated .\
OBJECTIVE	The primary endpoint was 1-year survival with local control ( SLC ) .\
METHODS	Patients with Stage III and IV ( UICC ) unresectable oro - and hypopharyngeal carcinomas were randomized for HF-ACC-RCT with 2 cycles of 5-FU ( 600 mg/m ( 2 ) / day ) / carboplatinum ( 70 mg/m ( 2 ) ) on days 1 -- 5 and 29 -- 33 ( arm A ) or HF-ACC-RT alone ( arm B ) .\
METHODS	In both arms , there was a second randomization for testing the effect of prophylactically given G-CSF ( 263 microg , days 15 -- 19 ) on mucosal toxicity .\
METHODS	Total RT dose in both arms was 69.9 Gy in 38 days , with a concomitant boost regimen ( weeks 1 -- 3 : 1.8 Gy/day , weeks 4 and 5 : b.i.d. RT with 1.8 Gy/1 .5 Gy ) .\
METHODS	Between July 1995 and May 1999 , 263 patients were randomized ( median age 56 years ; 96 % Stage IV tumors , 4 % Stage III tumors ) .\
RESULTS	This analysis is based on 240 patients : 113 patients with RCT and 127 patients with RT , qualified for protocol and starting treatment .\
RESULTS	There were 178 oropharyngeal and 62 hypopharyngeal carcinomas .\
RESULTS	Treatment was tolerable in both arms , with a higher mucosal toxicity after RCT .\
RESULTS	Restaging showed comparable nonsignificant different CR + PR rates of 92.4 % after RCT and 87.9 % after RT ( p = 0.29 ) .\
RESULTS	After a median observed time of 22.3 months , l - and 2-year local-regional control ( LRC ) rates were 69 % and 51 % after RCT and 58 % and 45 % after RT ( p = 0.14 ) .\
RESULTS	There was a significantly better 1-year SLC after RCT ( 58 % ) compared with RT ( 44 % , p = 0.05 ) .\
RESULTS	Patients with oropharyngeal carcinomas showed significantly better SLC after RCT ( 60 % ) vs. RT ( 40 % , p = 0.01 ) ; the smaller group of hypopharyngeal carcinomas had no statistical benefit of RCT ( p = 0.84 ) .\
RESULTS	For both tumor locations , prophylactically given G-CSF was a poor prognostic factor ( Cox regression ) , and resulted in reduced LRC ( log-rank test : + / - G-CSF , p = 0.0072 ) .\
CONCLUSIONS	With accelerated radiotherapy , the efficiency of simultaneously given chemotherapy may be not as high as expected when compared to standard fractionated RT. .\
CONCLUSIONS	Oropharyngeal carcinomas showed better LRC after HF-ACC-RCT vs. HF-ACC-RT ; hypopharyngeal carcinomas did not .\
CONCLUSIONS	Prophylactic G-CSF resulted in an unexpected reduced local control and should be given in radiotherapy regimen only with strong hematologic indication .\
\
###21156974\
BACKGROUND	Nonsteroidal antiinflammatory drugs have become increasingly popular as part of multimodal analgesic regimens for pain management in the ambulatory setting .\
BACKGROUND	We designed this randomized , double-blind , placebo-controlled study to evaluate the effect of postoperative administration of either a nonselective nonsteroidal antiinflammatory drug ( ibuprofen ) or the cyclooxygenase-2 selective inhibitor ( celecoxib when administered as part of a multimodal analgesic regimen ) on the severity of pain , the need for rescue analgesics , and clinically relevant patient outcomes after ambulatory surgery .\
BACKGROUND	The primary end point was the time to resumption of normal activities of daily living .\
METHODS	One hundred eighty patients undergoing outpatient surgery were randomly assigned to 1 of 3 treatment groups : group 1 ( control ) received either 2 placebo capsules ( matching celecoxib ) or 1 placebo tablet ( matching ibuprofen ) in the recovery room and 1 placebo tablet at bedtime on the day of surgery , followed by 1 placebo capsule or tablet 3 times a day for 3 days after discharge ; group 2 ( celecoxib ) received celecoxib 400 mg ( 2 capsules ) orally in the recovery room and 1 placebo capsule and tablet at bedtime on the day of surgery , followed by celecoxib 200 mg ( 1 capsule ) twice a day + placebo capsule every day at bedtime for 3 days after surgery ; or group 3 ( ibuprofen ) received ibuprofen 400 mg ( 1 tablet ) orally in the recovery room and 400 mg orally at bedtime on the day of surgery , followed by 400 mg orally 3 times a day for 3 days after surgery .\
METHODS	Recovery times , postoperative pain scores , and the need for rescue analgesics were recorded before discharge .\
METHODS	Follow-up evaluations were performed at 24 hours , 48 hours , 72 hours , 7 days , and 30 days after surgery to assess postdischarge pain , analgesic requirements , resumption of normal activities , opioid-related side effects , as well as quality of recovery and patient satisfaction with their postoperative pain management using a 5-point verbal rating scale .\
RESULTS	The 3 groups did not differ with respect to their demographic characteristics .\
RESULTS	Compared with the placebo treatment , both celecoxib and ibuprofen significantly decreased the need for rescue analgesic medication after discharge ( P < 0.05 ) .\
RESULTS	The effect sizes ( celecoxib and ibuprofen versus control group ) were 0.73 to 1 and 0.3 to 0.8 , respectively .\
RESULTS	Quality of recovery scores and patient satisfaction with their postoperative pain management were also improved in the celecoxib and ibuprofen groups compared with the control group ( P < 0.05 , effect size [ vs control group ] = 0.67 ) .\
RESULTS	The incidence of postoperative constipation was significantly higher in the control group ( 28 % ) compared with the celecoxib ( 5 % ) and ibuprofen ( 7 % ) groups , respectively ( P < 0.05 ) .\
RESULTS	Both active treatments were well tolerated in the postdischarge period .\
RESULTS	However , the time to resumption of normal activities of daily living was similar among the 3 groups .\
CONCLUSIONS	Both ibuprofen ( 1200 mg/d ) and celecoxib ( 400 mg/d ) significantly decreased the need for rescue analgesic medication in the early postdischarge period , leading to an improvement in the quality of recovery and patient satisfaction with their pain management after outpatient surgery .\
\
###11741055\
BACKGROUND	There is controversy surrounding the relative effectiveness of local irradiation and oral indomethacin for prophylaxis against heterotopic ossification following surgical treatment of acetabular fractures .\
BACKGROUND	The purpose of this study was to compare the efficacy of these two commonly used methods in a prospective , randomized trial .\
METHODS	From July 1992 to June 1999 , 166 patients in whom a fracture of the acetabulum was treated surgically through a posterior , extensile , or combination approach were randomized to receive either indomethacin or radiation therapy postoperatively .\
METHODS	Seventy-eight patients received 800 cGy of local radiation therapy within seventy-two hours after surgery , and seventy-two patients received a six-week course of indomethacin ( 25 mg three times a day ) beginning within twenty-four hours after surgery .\
METHODS	Sixteen additional patients were randomized but did not receive treatment with either prophylactic regimen .\
METHODS	At an average of fourteen months , the extent of heterotopic ossification was assessed on plain radiographs with use of the classification of Brooker et al. .\
METHODS	The grade of ossification was correlated with hip motion .\
RESULTS	There was no significant difference between treatment groups with regard to patient age , gender , Glasgow Coma Scale , operative time , estimated operative blood loss , duration of follow-up , or presence of closed head injury .\
RESULTS	The Injury Severity Score appeared to be the only covariate that was significantly different between the groups ( p = 0.019 ) .\
RESULTS	Grade-III or IV ossification developed in eight ( 11 % ) of the patients in the indomethacin group and three ( 4 % ) in the radiation therapy group .\
RESULTS	The difference was not significant ( p = 0.22 ; 95 % confidence interval , -1.1 % , +15.7 % ) .\
RESULTS	No complications related to the prophylaxis were noted in either group .\
RESULTS	Heterotopic ossification developed in all sixteen patients who did not receive prophylaxis , with six demonstrating grade-III or IV changes .\
RESULTS	The overall prevalence of grade-III or IV heterotopic ossification was 7 % ( eleven of 150 ) in the treated groups and 38 % ( six of sixteen ) in the untreated group .\
RESULTS	We did not find any association between the prevalence of heterotopic ossification and fracture type ( p = 0.296 ) or posterior hip dislocation ( p = 0.306 ) .\
RESULTS	Grade-I , II , and III heterotopic ossification did not decrease the range of motion of the hip except in flexion .\
CONCLUSIONS	Both local radiation therapy and indomethacin were found to provide effective prophylaxis against heterotopic ossification following surgical treatment of acetabular fractures through a posterior or extensile approach .\
CONCLUSIONS	We detected no significant difference in efficacy between the two prophylactic regimens .\
\
###20118146\
BACKGROUND	Pain sensitizes the central nervous system via N-methyl-D-aspartate receptors ( NMDARs ) leading to an enhancement of pain perception .\
BACKGROUND	However , the enhanced responsiveness of pain-processing areas can be suppressed by subanaesthetic doses of the NMDAR antagonist xenon .\
BACKGROUND	To analyse the strength of the analgesic effect of low-dose xenon using new economical application methods , we tested xenon applied nasally in an experimental human pain setting .\
METHODS	We tested 10 healthy volunteers using a multimodal experimental pain testing in a randomized double-blind placebo-controlled repeated measures study .\
METHODS	Xenon was administered using a novel low-pressure intranasal application device .\
METHODS	Additionally , we measured xenon concentrations in blood samples obtained from intracranial veins of experimental animals to describe the pharmacokinetics of intranasally applied xenon in the cerebral compartment .\
RESULTS	Intranasal application of xenon at a rate of 1.0 litre h ( -1 ) for 30 min significantly increased pain tolerance of volunteers to ischaemic ( +128 % ) , cold ( +58 % ) , and mechanical ( +40 % ) stimulation ( P < 0.01 ) .\
RESULTS	However , 60 min after terminating the application of xenon , there was no significant alteration of pain tolerance compared with placebo .\
RESULTS	Cranial blood concentrations of xenon in pigs reached a steady state of approximately 450 nl ml ( -1 ) after 5 min .\
CONCLUSIONS	In this placebo-controlled experimental human study , we described the increased pain tolerance induced by intranasally applied xenon .\
CONCLUSIONS	On the basis of our results , we conclude that intranasally administered xenon has analgesic properties and suggest that the novel application device presented here offers new possibilities for the administration of NMDAR antagonists within a multimodal analgesia approach .\
\
###12170410\
OBJECTIVE	As a bowel cleansing agent for colonoscopy , sodium phosphate ( NaP ) has been reported to have equal effectiveness and better patient tolerance in comparison with 4 l polyethylene glycol-electrolyte lavage ( PEG-EL ) solution .\
OBJECTIVE	Poor patient tolerance is frequently associated with a large amount of fluid consumed , and better patient tolerance might therefore be expected if the volume of PEG-EL solution could be reduced .\
OBJECTIVE	This study aimed to compare 2 l PEG-EL solution with NaP in relation to patients ' tolerance and its effectiveness as a bowel cleansing agent .\
METHODS	Two hundred consecutive patients admitted to the day-procedure ward for elective colonoscopy were prospectively randomized to receive either a 2-l PEG-EL solution or a 90-ml oral NaP regimen .\
METHODS	Patients with a history of congestive heart failure , impaired renal function ( creatinine > 1.5 mg/dl ) , or previous colectomy were excluded from the study .\
METHODS	The patients completed a questionnaire to assess their tolerance of bowel preparation before the colonoscopy .\
METHODS	Endoscopists , who were blinded to the type of regimen that had been used , scored the adequacy of bowel preparation from the rectum to cecum using a defined endoscopic score .\
RESULTS	Two hundred patients were included in this randomized trial .\
RESULTS	Nine patients were excluded , due to either an incomplete questionnaire ( two in the PEG-EL group , one in the NaP group ) or inability to complete the bowel preparation regimen ( four in the PEG-EL group and two in the NaP group ) .\
RESULTS	The demographic data were comparable in the two groups .\
RESULTS	There were no differences between the two groups with regard to willingness to repeat the regimen , ease of consumption , acceptability of the bowel preparation regimen , or the endoscopists ' satisfaction with the quality of bowel preparation .\
RESULTS	The NaP group had a better mean endoscopic score at the cecum compared with the PEG-EL group ( 1.47 + / - 1.15 vs. 1.05 + / - 0.76 ; P = 0.007 ) .\
CONCLUSIONS	The effectiveness and patient tolerance of the 2-l PEG-EL solution is comparable with that of oral NaP .\
CONCLUSIONS	The 2-l PEG-EL solution is therefore an effective alternative as a bowel-cleansing agent for colonoscopy .\
\
###12699051\
BACKGROUND	The use of dental floss has long been considered to be effective in controlling interproximal plaque and gingivitis .\
BACKGROUND	The authors compared this method with that of use of a mouthrinse .\
METHODS	Subjects with mild-to-moderate gingivitis enrolled in a long-term , six-month study .\
METHODS	They received a dental prophylaxis and were randomized into one of the three following treatment groups : brushing and rinsing with an essential oil-containing mouthrinse ( the BEO group ) , brushing and flossing ( the BF group ) and brushing and rinsing with a control rinse ( the B group ) .\
RESULTS	A total of 326 subjects were evaluated .\
RESULTS	The BEO and BF had significantly lower ( P < .001 ) mean interproximal Modified Gingival Index , or MGI , scores than did the B group at six months .\
RESULTS	The BEO group had lower mean interproximal Plaque Index , or PI , scores than the other two groups at both three and six months .\
RESULTS	The BF group 's mean PI score was significantly lower than the B group 's mean score at six months only .\
RESULTS	The magnitude of reductions for the BEO and the BF groups ( vs. the B group ) in MGI were 11.1 percent and 4.3 percent and for PI were 20.0 percent and 3.4 percent , respectively .\
CONCLUSIONS	In conjunction with professional care ( prophylaxis ) and toothbrushing over six months , rinsing twice daily with an essential oil-containing mouthrinse was at least as good as flossing daily in reducing interproximal plaque and gingivitis .\
CONCLUSIONS	Clinical Implications .\
CONCLUSIONS	When weighing recommendations for oral hygiene home care , clinicians should consider that an essential oil-containing mouthrinse may be a useful adjunct in patients with gingival inflammation .\
\
###18258768\
OBJECTIVE	The purpose of this case report is to describe the responses of 4 patients with chronic heart failure ( CHF ) to a novel rehabilitation program : a group-based , high-intensity , interval-training program that includes aerobic , resistance , flexibility , and balance activities .\
METHODS	Four patients ( 55-71 years of age ) with CHF ( New York Heart Association class III ) participated in the rehabilitation program twice per week for 16 weeks .\
METHODS	Outcome measures included a 6-minute walk test ( 6MWT ) , a cycle ergometer test ( aerobic capacity ) , and a quality-of-life questionnaire .\
RESULTS	Patients 1 , 2 , and 3 increased their aerobic capacity ( 17 % , 25 % , and 52 % , respectively ) .\
RESULTS	Patient 4 did not complete the cycle ergometer test because of limitations associated with his pacemaker .\
RESULTS	All patients increased their 6MWT distance ( 117 , 66 , 135 , and 143 m for patients 1 , 2 , 3 , and 4 , respectively ) .\
RESULTS	No adverse events were reported .\
CONCLUSIONS	The Norwegian Ullevaal Model of cardiac rehabilitation is a novel high-intensity , interval-training program .\
CONCLUSIONS	The 4 patients with CHF in this case series who participated in this program experienced improvements in physical capacity and quality of life and had no adverse events .\
CONCLUSIONS	These results are consistent with recent evidence supporting the efficacy of high-intensity interval training in people with CHF .\
CONCLUSIONS	Randomized clinical trials are needed to evaluate the clinical efficacy of this group-based , high-intensity , aerobic interval-training program for patients with CHF .\
\
###17612356\
METHODS	Prospective , randomized controlled trial .\
OBJECTIVE	To examine the effects of a 4-week rehabilitation program for chronic ankle instability ( CAI ) on postural control and lower extremity function .\
BACKGROUND	CAI is associated with residual symptoms , performance deficits , and reinjury .\
BACKGROUND	Managing CAI is challenging and more evidence is needed to guide effective treatment .\
METHODS	Subjects with unilateral CAI were randomly assigned to the rehabilitation ( CAI-rehab , n = 16 ) or control ( CAI-control , n = 13 ) group .\
METHODS	Subjects without CAI were assigned to a healthy group ( n = 19 ) .\
METHODS	Baseline testing included the ( 1 ) center of pressure velocity ( COPV ) , ( 2 ) star excursion balance test ( SEBT ) , and ( 3 ) Foot and Ankle Disability index ( FADI ) and FADI-Sports Subscale ( FADI-Sport ) .\
METHODS	The CAI-rehab group completed 4 weeks of rehabilitation that addressed range of motion , strength , neuromuscular control , and functional tasks .\
METHODS	After 4 weeks , all subjects were retested .\
METHODS	Nonparametric analyses for group differences and between-group comparisons were performed .\
RESULTS	Subjects with CAI demonstrated deficits in postural control and SEBT reach tasks of the involved limb compared to the uninvolved limb and reported functional deficits of the involved limb compared to healthy subjects .\
RESULTS	Following rehabilitation , the CAI-rehab group had greater SEBT reach improvements on the involved limb than the other groups and greater improvements in FADi and FADI-Sport scores .\
CONCLUSIONS	These results demonstrate postural control and functional limitations exist in individuals with CAl .\
CONCLUSIONS	In addition , rehabilitation appears to improve these functional limitations .\
CONCLUSIONS	Finally , there is evidence to suggest the SEBT may be a good functional measure to monitor change after rehabilitation for CAI .\
\
###24220099\
OBJECTIVE	Increasing levels of physical activity in mothers have long-term health benefits for the mother and family .\
OBJECTIVE	The study aimed to evaluate the effect of a six-month , physical activity RCT for mothers of young children .\
METHODS	Women were recruited via playgroups and randomly assigned to intervention ( n = 394 ) or control group ( n = 322 ) .\
METHODS	The intervention group received a six-month multi-strategy programme delivered via playgroups in Perth , Australia .\
METHODS	measures were mean minutes per week of moderate ( M ) and vigorous ( V ) intensity physical activity ( PA ) , and number of days/week of muscle strength exercises .\
RESULTS	The intervention had a significant effect on mean time for vigorous ( p = 0.008 ) , moderate ( p = 0.023 ) and total physical activity ( p = 0.001 ) when compared to the control group .\
RESULTS	The intervention group increased their vigorous activity by a mean of 24min/week , moderate activity by 23min/week and total physical activity by 72min/week .\
CONCLUSIONS	A relatively minimum home based intervention was able to demonstrate modest but statistically significant improvements in physical activity in a hard to reach group .\
CONCLUSIONS	These changes if maintained over a longer period are likely to improve the health of mothers and have a positive impact on their partners and children .\
CONCLUSIONS	Australian and New Zealand Clinical Trials Registry ACTRN12609000735257 .\
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###22048929\
OBJECTIVE	Pharmacists have been shown to improve medication reconciliation at hospital admission .\
OBJECTIVE	Limited resources may obligate pharmacy departments to target resources for medication reconciliation rather than extend services to the entire hospital .\
OBJECTIVE	We conducted a prospective , randomized , nonblinded assessment of the effectiveness and feasibility of pharmacist-led admission medication reconciliation for geriatric patients .\
METHODS	Eighty-one geriatric patients were randomized 1:1 to receive medication reconciliation per current hospital practice or to pharmacist-led medication reconciliation at admission .\
METHODS	The primary end point was medication profile appropriateness by pharmacist review at 48 hours postadmission .\
METHODS	Secondary end points involved in determining the impact and feasibility of this program .\
RESULTS	Pharmacist-led medication was superior to standard hospital practice , with 48 % of controls and 71 % of intervention patients having appropriate medication profiles at 48 hours postadmission ( P = .033 ) .\
RESULTS	Pharmacists identified 116 discrepancies among 81 patients including predominantly omissions ( 41 % ) and a composite of wrong dose , route , or frequency ( 35 % ) .\
RESULTS	Pharmacists spent a median 15 minutes per patient .\
CONCLUSIONS	Pharmacists improved admission medication reconciliation for geriatric patients .\
CONCLUSIONS	Pharmacists identified a significant number of discrepancies , including predominantly omissions and wrong dose , dosage form , or frequency .\
CONCLUSIONS	Pharmacists ' contributions to medication reconciliation could yield substantial benefit to patient care .\
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###21057561\
BACKGROUND	Cytokines are proposed to play important roles in brain tumor biology as well as neurodegeneration or impaired neuronal function .\
OBJECTIVE	This work aimed to check the association of polymorphisms of cytokine genes in Egyptian cases with brain tumors .\
METHODS	This work included 45 cases affected by brain tumors diagnosed as 24 benign and 21 malignant .\
METHODS	Their median age was 45 years , and they were 20 males and 25 females .\
METHODS	These cases were taken randomly from the Neurosurgery Department of Mansoura University Hospital , Egypt .\
METHODS	Case genotypes were compared to 98 healthy unrelated controls from the same locality .\
METHODS	DNA was amplified using PCR utilizing sequence specific primers ( SSP ) for detection of polymorphisms related to TNF-a-308 ( G/A ) , IL-10-1082 ( G/A ) , IL-6-174 ( G/C ) and IL-1Ra ( VNTR ) genes .\
RESULTS	Cases affected with benign brain tumors showed a significant higher frequency of IL-10-1082 A/A [ odds ratio ( OR = 8.0 ) , p < 0.001 ] and IL-6-174 C/C ( OR = 6.3 , p = 0.002 ) homozygous genotypes as compared to controls .\
RESULTS	Malignant cases , on the other hand , showed significantly higher frequency of IL-6-174 C/C ( OR = 4.8 , p = 0.002 ) homozygous genotype and TNF-a-308 A/A ( OR = 4.9 , p < 0.001 ) homozygous genotype when compared to controls .\
RESULTS	In the meantime , all cases showed no significant difference regarding the distribution of IL-1Ra VNTR genotype polymorphism compared to controls .\
CONCLUSIONS	Cytokine gene polymorphisms showed a pattern of association with brain tumors which may have potential impact on family counseling and disease management .\
\
###20170522\
BACKGROUND	LeptiCore is a proprietary combination of various ingredients which have been shown to have properties which could be beneficial to weight loss in obese and overweight human subjects .\
BACKGROUND	This study evaluates the effect of Lepticore on bodyweight as well as parameters associated with obesity and metabolic syndrome .\
METHODS	The study was an 8 week randomized , double-blind , placebo-controlled design involving 92 obese ( mean BMI > 30 kg/m2 ) participants ( 37 males ; 55 females ; ages 19-52 ; mean age = 30.7 ) .\
METHODS	The participants were randomly divided into three groups : placebo ( n = 30 ) , LeptiCore formula A ( low dose ) ( n = 31 ) and LeptiCore formula B ( high dose ) ( n = 31 ) .\
METHODS	Capsules containing the placebo or active formulations were administered twice daily before meals with 300 ml of water .\
METHODS	None of the participants followed any specific diet nor took any weight-reducing medications for the duration of the study .\
METHODS	A total of 12 anthropomorphic and serological measurements were taken at the beginning of the study and after 2 , 4 , 6 , and 8 weeks of treatment .\
RESULTS	Compared to the placebo group , the two active groups showed statistically significant differences on all 12 variables by week 8 .\
RESULTS	These included four anthropomorphic variables ( body weight , body fat , waist and hip size ) and eight measures of serological levels ( plasma total cholesterol , LDL , HDL , triglycerides , blood glucose , serotonin , leptin , C-reactive protein ) .\
RESULTS	The two active groups also showed significant intra-group differences on all 12 variables between study onset and week 8 .\
CONCLUSIONS	The LeptiCore formulation at both the low and high dosages appears to be helpful in the management of fat gain and its related complications .\
CONCLUSIONS	The higher dosage resulted in significantly greater reductions in body weight and triglyceride , blood glucose , and C-reactive protein levels , as well as increased serotonin levels .\
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###21944048\
BACKGROUND	Chemoradiotherapy is increasingly applied in patients with oesophageal cancer .\
BACKGROUND	The aim of the present study was to determine whether 3D-CT volumetry is able to differentiate between responding and non-responding oesophageal tumours early in the course of neoadjuvant chemoradiotherapy .\
METHODS	Serial CT before and after two weeks of neoadjuvant chemoradiotherapy was performed in the multimodality treatment arm of a randomised trial including patients with oesophageal carcinoma .\
METHODS	CT response was measured with the change in tumour volume between baseline and after 14 days of neoadjuvant therapy .\
METHODS	Receiver Operating Characteristic ( ROC ) analysis was used to evaluate the ability of 3D-CT as an early imaging marker of response .\
RESULTS	CT response analysis was performed in 39 patients , of whom 26 patients were histopathological responders .\
RESULTS	Median tumour volume increased between baseline and after 14 days of chemoradiotherapy in histopathological responders as well as in non-responders , though changes were not statistically significant .\
RESULTS	The area under the ROC curve was 0.71 .\
CONCLUSIONS	Tumour volume changes after 14 days of neoadjuvant chemoradiotherapy as measured by 3D-CT were not associated with histopathological tumour response .\
CONCLUSIONS	CT volumetry should not be used for early response assessment in patients with potentially curable oesophageal cancer treated with neoadjuvant chemoradiotherapy .\
\
###19667976\
OBJECTIVE	Assess the efficacy and tolerability of gabapentin enacarbil ( GEn ) , a transported prodrug of gabapentin with improved gabapentin exposure , in adults with moderate-to-severe primary restless legs syndrome .\
METHODS	This 14-day , double-blind , randomized , controlled trial of GEn at 1200 or 600 mg or placebo taken once daily , evaluated the mean change from baseline International Restless Legs Scale ( IRLS ) total score at end of treatment ( day 14 : primary comparison , GEn at 1200 mg vs placebo ) .\
METHODS	Secondary end points included Clinical Global Impression-Improvement scale outcomes at day 14 .\
RESULTS	Ninety-five subjects were randomized ( GEn : 1200 mg , n = 33 and 600 mg , n = 29 ; placebo , n = 33 ) ; 2 subjects ( GEn at 1200 mg ) withdrew because of adverse events .\
RESULTS	At day 14 , the mean ( SD ) change from baseline IRLS total score was significantly greater with GEn at 1200 mg ( -16.1 [ 7.93 ] ) compared with placebo ( -8.9 [ 7.72 ] ; adjusted mean treatment difference , -7.2 ; P < 0.0001 ) .\
RESULTS	Investigator-rated Clinical Global Impression-Improvement scale responses also significantly favored GEn at 1200 mg compared with placebo ( P G 0.0001 ) .\
RESULTS	The mean ( SD ) change from baseline IRLS total score with GEn at 600 mg at day 14 was -9.1 ( 5.95 ) , similar to placebo .\
RESULTS	The most commonly reported treatment-emergent adverse events were somnolence ( GEn : 1200 mg , 36 % and 600 mg , 14 % ; placebo ,15 % ) and dizziness ( GEn : 1200 mg , 18 % and 600 mg , 14 % ; placebo , 3 % ) , most of which were rated mild or moderate in intensity .\
CONCLUSIONS	Gabapentin enacarbil at 1200 mg significantly improved restless legs syndrome symptoms compared with placebo .\
CONCLUSIONS	Efficacy outcomes for GEn at 600 mg were similar to placebo .\
CONCLUSIONS	Both GEn doses were generally well tolerated .\
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###8976948\
OBJECTIVE	The purpose of this study was to determine hepatic , aortic , and portal vein enhancement with a new dimeric , nonionic , isotonic contrast medium ( iodixanol ) in a routinely performed helical CT protocol and compare enhancement characteristics with those of a monomeric , nonionic , low-osmolality contrast medium ( iopromide ) .\
METHODS	In 81 patients , we injected 150 ml of iodixanol ( 320 mg I/ml ) , iodixanol ( 300 mg I/ml ) , or iopromide ( 300 mg I/ml ) .\
METHODS	Injection rate was 5 ml/sec .\
METHODS	A dual-phase helical CT scan was obtained ( first helical scan began at 30 sec .\
METHODS	second helical scan began at 70 sec ) , and enhancement characteristics were assessed .\
METHODS	Results were analyzed taking into account various intrinsic parameters of patients .\
RESULTS	During the second imaging phase , iodixanol at 320 mg I/ml and iodixanol at 300 mg I/ml provided significantly higher enhancement of the liver ( 75 H , 69 H , 62 H ) , aorta ( 144 H , 140 H , 122 H ) , and portal vein ( 147 H , 147 H , 118 H ) than did iopromide at 300 mg I/ml .\
RESULTS	No significant differences were observed during the first imaging phase .\
CONCLUSIONS	The combination of higher vascular and parenchymal enhancement levels after injection of the isotonic agent may represent a different quality of tissue enhancement .\
CONCLUSIONS	Such an enhancement would be characterized more by a higher contribution of the blood pool compartment to absolute enhancement levels than by a contribution of the interstitial compartment .\
CONCLUSIONS	Further studies are needed to determine whether the use of isotonic agents effects lesion conspicuity .\
\
###12928686\
BACKGROUND	The Royal College of Ophthalmologists ' guidelines and Driver and Vehicle Licensing Agency ( DVLA ) recommend that a patient should not drive with dilated pupils based on the rationale that vision may be compromised in acuity and ability to tolerate glare .\
BACKGROUND	Arguments exist against these recommendations suggesting that pupillary dilatation does not have any real bearings on driving ability .\
BACKGROUND	Aim To determine the effects of pupillary dilatation on the ability to drive .\
METHODS	The study was randomised and prospective .\
METHODS	A total of 28 patients had their visual parameters ( distance vision , near vision , licence plate reading at 20 m or shorter , and glare ) measured and analysed pre - and post-tropicamide 1 % dilatation .\
METHODS	Paired two-tailed Student 's t-test and chi ( 2 ) - test were used in the analysis .\
RESULTS	At 20 min , following instillation of one drop of tropicamide 1 % there is a significant reduction in visual acuity ( VA ) , for distance Snellen and near .\
RESULTS	There is a significant reduction in the number of people who could read the licence plate at 20 m. Subjective glare assessment changed from ` none ' ( average score ) in the undilated state to ` mild ' in the dilated states .\
RESULTS	The overall patient feedback indicated that a significant 14 % believed they would find it difficult to drive postdilatation .\
CONCLUSIONS	This study demonstrates the rationale behind disallowing driving following pupillary dilatation .\
CONCLUSIONS	The risks to safe driving are proved significant as a result of significant reduction in visual quality and quantity after dilatation .\
\
###18767583\
OBJECTIVE	To compare clinical therapeutic effects of acupuncture along channel and routine acupuncture on prolapse of lumbar intervertebral disc .\
METHODS	One hundred and sixty-five cases were randomly divided into an observation group ( n = 85 ) and a control group ( n = 80 ) .\
METHODS	The observation group were treated with acupuncture at corresponding channel points according to types of the Gallbladder Channel and the Bladder Channel , and the control group were treated with acupuncture at routinely selected acupoints .\
METHODS	Their therapeutic effects after treatment of 4 courses and their recurrence rates half a year later were observed .\
RESULTS	The cured and markedly effective rate of 88.2 % and the recurrence rate of 24.0 % in the observation group were significantly better than 72.5 % and 41.4 % in the control group , with significant differences between the two groups ( both P < 0.05 ) .\
CONCLUSIONS	Corresponding channel point selection for treatment of prolapse of lumbar intervertebral disc has significant short-term and long-term therapeutic effects .\
\
###22019971\
OBJECTIVE	The aim of this study was to evaluate the effects of virtual reality ( VR ) treadmill training on the balance skills of patients who have had a stroke .\
METHODS	A total of 14 patients with strokes were recruited and randomly assigned to receive VR treadmill or traditional treadmill training .\
METHODS	The outcome measures that were included for the study were center of pressure ( COP ) sway excursion , COP maximum sway in anterior-posterior direction , COP maximum sway in medial-lateral direction , COP sway area , bilateral limb-loading symmetric index , the sway excursion values for the paretic foot ( sway excursion/P ) , paretic limb stance time ( stance time/P ) , number of steps of the paretic limb ( number of steps/P ) , and contact area of the paretic foot ( contact A/P ) during quiet stance , sit-to-stand transfer , and level walking .\
RESULTS	There were no significant improvements in COP-related measures and symmetric index during the quiet stance , either in the VR treadmill or traditional treadmill training group ( P > 0.05 ) .\
RESULTS	However , the difference between groups after training in COP maximum sway in medial-lateral direction during the quiet stance was significant ( P = 0.038 ) .\
RESULTS	Traditional treadmill training failed to improve sit-to-stand performance , whereas VR treadmill training improved symmetric index ( P = 0.028 ) and sway excursion ( P = 0.046 ) significantly during sit-to-stand transfer .\
RESULTS	The changes of symmetric index between groups were markedly different ( P = 0.045 ) .\
RESULTS	Finally , both groups improved significantly in stance time/P , but only VR treadmill training increased contact A/P ( P = 0.034 ) after training during level walking .\
RESULTS	The difference between groups during level walking was not significant .\
CONCLUSIONS	Neither traditional treadmill nor VR treadmill training had any effect on balance skill during quiet stance , but VR treadmill training improved balance skill in the medial-lateral direction better than traditional training did .\
CONCLUSIONS	VR treadmill training also improved balance skill during sit-to-stand transfers and the involvement of paretic limb in level walking more than the traditional one did .\
\
###16612257\
BACKGROUND	It has been suggested that inappropriate stimulation of the renin-angiotensin system ( RAS ) is responsible for the increase in blood pressure that occurs in autosomal-dominant polycystic kidney disease ( ADPKD ) before the development of renal failure .\
BACKGROUND	However , the interpretation of previous studies in ADPKD patients is confounded by inadequate matching with control populations for blood pressure and renal function , or failure to control the sodium intake of participants .\
METHODS	A double-blind , placebo-controlled study of two different sodium intakes ( 350 and 50 mmol/day for 5 days ) in a group of 11 hypertensive ADPKD patients and eight matched control subjects with essential hypertension .\
METHODS	In addition , blood pressure and hormonal responses were measured after the administration of the angiotensin-converting enzyme inhibitor enalapril for 3 days .\
RESULTS	Blood pressure and hormonal responses of the RAS after a reduction in sodium intake and after the administration of enalapril were identical in ADPKD patients and controls .\
CONCLUSIONS	Activation of the classic circulating RAS is no greater in hypertensive ADPKD patients than in individuals with essential hypertension .\
\
###15293423\
OBJECTIVE	To evaluate the efficacy of two adhesive systems in reducing microleakage when applied with three different adhesive placement techniques .\
METHODS	Sixty freshly extracted caries-free human premolars and molars were used .\
METHODS	MO/DO Class II standardized preparations were performed with the gingival margin placed 1 mm above the CEJ .\
METHODS	Teeth were randomly divided into 2 groups ( group I : Prime & Bond NT , Dentsply/Caulk ; group II : Single Bond , 3M Espe ) .\
METHODS	Each group was divided into 3 subgroups : ( A ) application of 2 coats and one cure : IA-IIA ; ( B ) 2 coats and 2 cures of each adhesive system : IB-IIB ; and ( C ) one coat of each adhesive along with the manufacturers ' B1 flowable resin ( 0.5-mm thick layer ) cured together at once : IC-IIC .\
METHODS	Each coat was cured for 20 s at 800 mW/cm2 using a quartz-tungsten halogen light ( Elipar Trilight , 3M ESPE ) .\
METHODS	Teeth were then restored using 2-mm increments of an A2 microhybrid composite ( Esthet-X , Dentsply/Caulk ) .\
METHODS	All teeth were stored in distilled water at 37 degrees C for 24 h , thermocycled ( 500x , 5 degrees to 55 degrees C , 30 s dwell ) and then placed in a 0.5 % methylene blue dye solution for 24 h at 37 degrees C. Samples were sectioned longitudinally and evaluated for microleakage at the gingival margin under a stereomicroscope at 20x magnification .\
METHODS	Dye penetration was scored using an ordinal scoring system , where 0 : no penetration ; 1 : enamel penetration ; 2 : gingival dentin penetration ; 3 : axial dentin penetration .\
METHODS	Kruskal-Wallis and Mann-Whitney tests were used .\
RESULTS	A Mann-Whitney U-Test revealed no statistically significant difference between subgroups .\
RESULTS	Although not statistically significant , P&B NT ( two coats and one cure ) revealed the lowest microleakage scores .\
CONCLUSIONS	In the experimental model adopted for this study , microleakage was not affected either by the adhesive or its placement technique .\
\
###9572210\
OBJECTIVE	To establish the optimum oral daily dose of micronized medroxyprogesterone acetate , given in combination with a fixed oral dose of estrone ( E1 ) sulfate as hormone replacement therapy , that provides endometrial protection and induces cessation of vaginal bleeding .\
METHODS	This multicenter , randomized , double-blind study was conducted for 2 years .\
METHODS	Five hundred sixty-eight postmenopausal women were randomized to take E1 sulfate 1.25 mg daily and one of three doses of medroxyprogesterone acetate ( 2.5 , 5 , or 10 mg ) daily .\
METHODS	Any vaginal bleeding was recorded by patients in a daily diary , and endometrial biopsies were performed at entry into the study and at 3 , 12 , and 24 months .\
RESULTS	Forty-two percent of all women reported some bleeding at month 3 of therapy .\
RESULTS	However , by month 6 , 76.5 , 80.1 , and 80.9 % of women were amenorrheic in the 2.5 - , 5 - , and 10-mg medroxyprogesterone acetate groups , respectively .\
RESULTS	Over time , the percentage of women with no bleeding increased in each group , and by 24 months 91.5 , 89.9 , and 94.3 % were amenorrheic in the 2.5 - and 10-mg medroxyprogesterone acetate groups , respectively .\
RESULTS	Approximately 10 % of women continue to have some bleeding , regardless of the dose of medroxyprogesterone acetate .\
RESULTS	There were no statistically significant differences in the number of women with bleeding at any time point between the three groups .\
RESULTS	There were no cases of endometrial hyperplasia reported in the study population over the 2 years .\
CONCLUSIONS	All three studied doses of medroxyprogesterone acetate , given in combination with 1.25 mg of E1 sulfate , provide adequate endometrial protection and render approximately 80 % of women amenorrheic by 6 months of therapy .\
\
###24861276\
OBJECTIVE	To assess the comparative drug systemic exposure of a reference ( RF ) and four test ( Test I , Test II , Test III and Test IV ) formulations of triclabendazole ( TCBZ ) in heifers .\
METHODS	Thirty Holstein heifers were randomly distributed into five groups ( n = 6 per group ) .\
METHODS	Animals in the RF group received the reference formulation ( Fasinex ) , and those in the other groups received different commercially available TCBZ formulations ( Test I , Test II , Test III and Test IV ) .\
METHODS	All treatments were orally administered at 12 mg/kg bodyweight .\
METHODS	The concentrations of TCBZ metabolites in plasma between 0 and 168 hours after treatment were quantified by high-performance liquid chromatography ( HPLC ) .\
RESULTS	Triclabendazole sulphoxide ( TCBZ.SO ) and TCBZ-sulphone ( TCBZ.SO ) were the only analytes recovered in plasma .\
RESULTS	Only the Test I formulation did not differ from the RF for all pharmacokinetic parameters measured for either metabolite ( p > 0.8 ) .\
RESULTS	The TCBZ.SO area under the concentration vs. time curve for Test II formulation ( 268.9 g.h / mL ) was lower , and for Test III ( 619.9 g.h / mL ) and Test IV ( 683.4 g.h / mL ) was higher , than the RF ( 418.1 g.h / mL ) ( p < 0.005 ) .\
CONCLUSIONS	Based on the currently available bioequivalence criteria , the only test formulation under evaluation that could be considered equivalent to the RF was the Test I formulation , which demonstrated an equivalent systemic exposure for the active TCBZ.SO metabolite .\
CONCLUSIONS	This comparison of TCBZ pioneer and test formulations in cattle raises awareness of the need for further quality control for drug approval in the veterinary pharmaceutical field in many regions of the world .\
\
###23279003\
BACKGROUND	Ongoing evaluation of biological agents in patients with moderate-to-severe psoriasis is needed to support their long-term use .\
OBJECTIVE	To evaluate long-term efficacy and safety of ustekinumab through 5 years in the PHOENIX 1 study .\
METHODS	Patients were randomized to placebo or ustekinumab ( 45 mg or 90 mg ) at Weeks 0 , 4 and every-12-weeks thereafter ; placebo patients crossed-over to ustekinumab at Week 12 .\
METHODS	Clinical response through Week 244 was evaluated using the Psoriasis Area and Severity Index ( PASI ) in the Overall Population ( i.e. patients receiving 1 dose of ustekinumab ) , Initial Responders ( i.e. PASI 75 responders [ Weeks 28/40 ] re-randomized at Week 40 to continue every-12-week maintenance ) and Partial Responders ( i.e. < PASI 75 responders adjusted to every-8-week maintenance at Weeks 28 or 40 ) .\
METHODS	Safety endpoints were evaluated through Week 264 for the Overall Population .\
RESULTS	Overall , 68.7 % ( 517/753 ) of ustekinumab-treated patients completed treatment through Week 244 .\
RESULTS	Initial clinical responses were generally maintained through Week 244 ( PASI 75 : 63.4 % and 72.0 % ; PASI 90 : 39.7 % and 49.0 % ; PASI 100 : 21.6 % and 26.4 % ) for patients receiving 45 mg and 90 mg , respectively .\
RESULTS	Similarly , PASI 75 responses were generally maintained among Initial Responders [ 79.1 % ( 45 mg ) and 80.8 % ( 90 mg ) ] and Partial Responders [ 57.6 % ( 45 mg ) and 55.1 % ( 90 mg ) ] .\
RESULTS	With 3104 patient-years of follow-up , rates of overall adverse events ( AEs ) , serious AEs , serious infections , malignancies and major adverse cardiovascular events were generally consistent over time and comparable between doses .\
CONCLUSIONS	Through 5 years of continuous treatment , ustekinumab demonstrated stable clinical response and a safety profile consistent with previous reports .\
\
###21681084\
OBJECTIVE	Research has shown that cognitive and behavioral therapies can effectively improve quality of life in chronic pain patients .\
OBJECTIVE	Unfortunately , many patients lack access to cognitive and behavioral therapy treatments .\
OBJECTIVE	We developed a pilot version of an interactive online intervention to teach self-management skills for chronic lower back pain , a leading cause of disability and work absenteeism .\
OBJECTIVE	The objective of this randomized , controlled trial was to evaluate its efficacy .\
METHODS	Individuals with chronic lower back pain were recruited over the Internet , screened by phone , and randomly assigned to receive access to the intervention ( Wellness Workbook ; WW ) either immediately ( intervention group ) or after a 3-week delay ( wait-list control ) .\
METHODS	Participants ( n = 141 , 83 % female , 23 % minority ) were asked to complete the WW over 3 weeks .\
METHODS	Self-report measures of pain , disability , disabling attitudes and beliefs , self-efficacy for pain control , and mood regulation were completed at baseline , week 3 , and week 6 .\
RESULTS	Controlling for baseline individual differences in the outcome measures , multivariate analysis of covariance revealed that , at week 3 , the intervention group scored better than the wait-list control group on all outcomes , including pain severity ratings .\
RESULTS	At week 6 , after both groups had been exposed to the WW , there were no differences between groups .\
CONCLUSIONS	Use of this pilot intervention seems to have had positive effects on a number of pain-related outcomes , including disability .\
CONCLUSIONS	Future research will evaluate the effectiveness of the completed intervention , with particular attention to quality of life and disability .\
\
###18447762\
BACKGROUND	Women of reproductive age treated with isotretinoin are required to use two forms of contraceptives , yet adherence to the recommendations is limited .\
BACKGROUND	Our objective was to determine if an active intervention by a drug consultation center ( DCC ) will increase contraceptive use among women taking isotretinoin .\
METHODS	In a randomized , controlled study , women of reproductive age who called the DCC seeking advice regarding isotretinoin were randomly assigned to an intervention group ( information by phone during initial interview , by mailed written form , and by text messages sent to their cellular phones ) and a control group ( information given once ) .\
METHODS	A follow-up call was made to all women 3 months after the first interview .\
RESULTS	One hundred eight women ( 50 in the intervention group and 58 control ) were enrolled .\
RESULTS	Most women do not adhere to the recommended contraceptive use .\
RESULTS	After 3 months , 50 % of the study group and 40 % of the control group were using a contraceptive ( p = 0.41 ) , and only 2 women in each group used two methods of contraception .\
CONCLUSIONS	Strategies to increase adherence to contraceptive use among women treated with isotretinoin are needed .\
\
###18307223\
OBJECTIVE	To compare Angio-Seal ( AS ) and StarClose ( SC ) and manual compression ( MC ) on efficacy of hemostasis , complication rate , safety of early mobilization , and patient comfort .\
BACKGROUND	Closure of the femoral artery after cardiac catheterization can be obtained through different methods .\
BACKGROUND	Today , physicians can choose from a number of different devices to achieve arterial closure .\
METHODS	In a prospective trial 450 patients were randomized to AS , SC , or MC .\
METHODS	Patients were mobilized 1 to 2 hr after device placement , and 6 hr after MC .\
METHODS	Data were collected during hospital admission and by telephone at one month after hospital discharge .\
RESULTS	Devices were used in 138/150 allocated to AS and 124/150 allocated to SC patients ( 92 % vs. 83 % , P = 0.015 ) Patients with MC experienced more pain during sheath removal than patients receiving a device , and rated their period of bed rest as less comfortable .\
RESULTS	Oozing and need for pressure bandage at the puncture site were observed in 37 AS patients and 57 SC patients ( 25 % vs. 38 % , P = 0.002 ) .\
RESULTS	Hematoma occurred in 15 AS patients , in 17 SC patients , and in 14 MC patients ( 11 vs. 14 vs. 9 % , ns ) .\
CONCLUSIONS	There is no difference in safety between the three methods of arterial closure .\
CONCLUSIONS	SC was more often not used or successfully deployed .\
CONCLUSIONS	SC patients more often had continuing oozing .\
CONCLUSIONS	On patient comfort , closure devices performed better than MC .\
CONCLUSIONS	Early ambulation in patients with a closure device is safe .\
CONCLUSIONS	AS is the preferred method of arterial closure after cardiac catheterization .\
\
###23725316\
BACKGROUND	There is a lack of evidence for effective management of dental caries ( decay ) in children 's primary ( baby ) teeth and an apparent failure of conventional dental restorations ( fillings ) to prevent dental pain and infection for UK children in Primary Care .\
BACKGROUND	UK dental schools ' teaching has been based on British Society of Paediatric Dentistry guidance which recommends that caries in primary teeth should be removed and a restoration placed .\
BACKGROUND	However , the evidence base for this is limited in volume and quality , and comes from studies conducted in either secondary care or specialist practices .\
BACKGROUND	Restorations provided in specialist environments can be effective but the generalisability of this evidence to Primary Care has been questioned .\
BACKGROUND	The FiCTION trial addresses the Health Technology Assessment ( HTA ) Programmes commissioning brief and research question What is the clinical and cost effectiveness of restoration caries in primary teeth , compared to no treatment ?\
BACKGROUND	It compares conventional restorations with an intermediate treatment strategy based on the biological ( sealing-in ) management of caries and with no restorations .\
METHODS	This is a Primary Care-based multi-centre , three-arm , parallel group , patient-randomised controlled trial .\
METHODS	Practitioners are recruiting 1461 children , ( 3-7 years ) with at least one primary molar tooth where caries extends into dentine .\
METHODS	Children are randomized and treated according to one of three treatment approaches ; conventional caries management with best practice prevention , biological management of caries with best practice prevention or best practice prevention alone .\
METHODS	Baseline measures and outcome data ( at review/treatment during three year follow-up ) are assessed through direct reporting , clinical examination including blinded radiograph assessment , and child/parent questionnaires .\
METHODS	The primary outcome measure is the incidence of either pain or infection related to dental caries .\
METHODS	Secondary outcomes are ; incidence of caries in primary and permanent teeth , patient quality of life , cost-effectiveness , acceptability of treatment strategies to patients and parents and their experiences , and dentists preferences .\
CONCLUSIONS	FiCTION will provide evidence for the most clinically-effective and cost-effective approach to managing caries in children 's primary teeth in Primary Care .\
CONCLUSIONS	This will support general dental practitioners in treatment decision making for child patients to minimize pain and infection in primary teeth .\
CONCLUSIONS	The trial is currently recruiting patients .\
BACKGROUND	Protocol ID : NCTU : ISRCTN77044005 .\
\
###23057482\
OBJECTIVE	The aim of this study was to investigate whether acupuncture , especially Yamamoto 's New Scalp Acupuncture ( YNSA ) , is of value in additional to standard poststroke motor rehabilitation .\
METHODS	A prospective , assessor-blinded randomized control trial was carried out in an inpatient stroke rehabilitation unit with day hospital service .\
METHODS	After inclusion , patients were stratified into control group and acupuncture group , randomly .\
METHODS	The Barthel Index , the Rivermead Scale Index , and the Visual Analogue Scale were used to follow the efficacy of treatment .\
RESULTS	In the acupuncture group , all the sensory , motor , and functional scores improved significantly during the examination period until 2 years after injury .\
RESULTS	The Barthel Index is increased from 42 to 954 in the acupuncture group .\
RESULTS	This index also increased in the control group ( from 42 to 754 ) , but the changes were significantly less than in the acupuncture group .\
RESULTS	A significant spontaneous recovery during the 2-year follow-up was found , but the YNSA treatment facilitated the functional recovery .\
RESULTS	Improved moving function and more flexible joints and ligaments were observed in comparison to the patients ' condition prior to treatment .\
CONCLUSIONS	The data suggest that the YNSA is a useful method to treat stroke patients and enhance their quality of life .\
\
###15596631\
BACKGROUND	Previous studies have demonstrated low rates of advance care planning ( ACP ) , particularly among nonwhite populations , raising questions about the generalizability of this decision-making process .\
OBJECTIVE	To explore factors that may influence patients ' willingness to engage in ACP .\
METHODS	Survey .\
METHODS	Thirty-four randomly selected New York City senior centers .\
METHODS	A total of 700 African American ( n = 239 ) , Hispanic ( n = 237 ) , and white ( n = 224 ) adults 60 years and older .\
METHODS	Participants were administered a 51-item survey that assessed attitudes , beliefs , and practices regarding ACP .\
METHODS	Attitudes and beliefs about physicians ' trustworthiness , fatalism , beliefs about surrogate decision making , and comfort discussing end-of-life medical care ; factors associated with health care proxy completion ; and health care proxy completion rates .\
RESULTS	More than one third of the participants had completed a health care proxy .\
RESULTS	There were no significant differences in completion rates across the 3 ethnic groups .\
RESULTS	Respondents who had a primary care physician ( odds ratio [ OR ] , 2.0 ; 95 % confidence interval [ CI ] , 1.3-3 .2 ) , were more knowledgeable about advance directives ( OR , 2.0 ; 95 % CI , 1.4-2 .9 ) , or had seen a friend or family member use a mechanical ventilator ( OR , 1.5 ; 95 % CI , 1.02-2 .1 ) were significantly more likely to have designated a health care proxy .\
RESULTS	Respondents who were only comfortable discussing ACP if the discussion was initiated by the physician ( OR , 0.6 ; 95 % CI , 0.0-0 .8 ) were significantly less likely to have completed a health care proxy .\
CONCLUSIONS	African American , Hispanic , and white community-dwelling , older adults had similarly high rates of advance directive completion .\
CONCLUSIONS	The primary predictors of advance directive completion involved modifiable factors such as established primary care physicians , personal experience with mechanical ventilation , knowledge about the process of ACP , and physicians ' willingness to effectively initiate such discussions .\
CONCLUSIONS	Some of the racial/ethnic differences in desire for collective family-based decision making that were observed in this study have implications for the evolution of ACP policy that respects and operationalizes these preferences .\
\
###19061735\
OBJECTIVE	To evaluate the effectiveness of comprehensive , holistic neuropsychologic ( NP ) rehabilitation compared with standard , multidisciplinary rehabilitation for people with traumatic brain injury ( TBI ) .\
METHODS	Randomized practical controlled trial .\
METHODS	Postacute brain injury rehabilitation center within a suburban rehabilitation hospital .\
METHODS	Participants with TBI were recruited from clinical referrals and referrals from the community .\
METHODS	Sixty-eight participants who met inclusion criteria were randomly allocated to treatment conditions .\
METHODS	Most participants ( 88 % ) had sustained moderate or severe TBI , and greater than half ( 57 % ) were more than 1 year postinjury at the beginning of treatment .\
METHODS	Treatment was conducted 15 hours per week for 16 weeks .\
METHODS	Standard neurorehabilitation consisted primarily of individual , discipline specific therapies ( n = 34 ) .\
METHODS	Intensive cognitive rehabilitation emphasized the integration of cognitive , interpersonal , and functional interventions within a therapeutic environment ( n = 34 ) .\
METHODS	Primary outcomes were the Community Integration Questionnaire ( CIQ ) and Perceived Quality of Life scale ( PQOL ) .\
METHODS	Secondary outcomes included NP functioning , perceived self-efficacy , and community-based employment .\
RESULTS	NP functioning improved in both conditions .\
RESULTS	Intensive cognitive rehabilitation participants showed greater improvements on the CIQ ( effect size [ ES ] = 0.59 ) and PQOL ( ES = 0.30 ) as well as improved self-efficacy for the management of symptoms ( ES = 0.26 ) compared with standard neurorehabilitation treatment .\
RESULTS	These gains were maintained at the 6-month follow-up .\
RESULTS	Standard neurorehabilitation participants showed improved productivity at the 6-month follow-up associated with the need for continued rehabilitation .\
CONCLUSIONS	Improvements seen after intensive cognitive rehabilitation may be related to interventions directed at the self-regulation of cognitive and emotional processes and the integrated treatment of cognitive , interpersonal , and functional skills .\
CONCLUSIONS	The results show the effectiveness of comprehensive holistic NP rehabilitation for improving community functioning and quality of life after TBI compared with standard rehabilitation .\
\
###9663832\
BACKGROUND	The reliability of symptom data collected during efficacy studies in irritable bowel syndrome ( IBS ) is paramount to the proper assessment of potential therapeutic agents .\
BACKGROUND	Historically , data have been collected on paper diary cards , which patients were requested to fill out at a specified interval .\
BACKGROUND	However , with paper diary cards it is not possible to determine whether the cards are filled out as required , or at random times .\
BACKGROUND	To circumvent this problem , a novel electronic data collection system that ensures the reliability and security of data entry was used .\
METHODS	Data were collected from 640 patients during the 2-week screening and 12-week treatment phases of two multicentre trials of IBS .\
METHODS	The electronic data collection system used was based upon a touchtone telephone system .\
RESULTS	The electronic data collection system had a potential 8135 up-time hours during the study .\
RESULTS	An up-time of 8040 h and down-time of 95 h was observed .\
RESULTS	This corresponds to an up-time of approximately 99 % .\
RESULTS	Patient compliance for data entry in the two studies was 81 % and 83 % , respectively .\
RESULTS	On a single random day during their daily telephone call , patients were asked questions to assess satisfaction with the system .\
RESULTS	On aggregate , 79 % of patients were satisfied or very satisfied with the system , only 10 % were dissatisfied or very dissatisfied .\
CONCLUSIONS	A unique electronic data collection system was tested for use in clinical studies in IBS .\
CONCLUSIONS	This system provided 100 % reliability as to the date of data entry , and data were not subject to modification once entered .\
CONCLUSIONS	This methodology represents a marked advancement in clinical studies of IBS .\
\
###19834635\
OBJECTIVE	In a retrospective study , the sacrospinous hysteropexy was associated with a shorter recovery time compared to a vaginal hysterectomy with no differences in anatomical outcomes .\
OBJECTIVE	No randomized trials are performed .\
METHODS	Sixty-six women with stage 2-4 uterine descent were randomized for vaginal hysterectomy ( 31 ) or sacrospinous hysteropexy ( 35 ) .\
METHODS	Recovery time , anatomical outcomes , functional outcomes , and quality of life were measured .\
RESULTS	Length of time to return to work was shorter after a sacrospinous hysteropexy ( 43 versus 66 days , p = 0.02 ) .\
RESULTS	The difference in risk for recurrent prolapse stage 2 or more of the apical compartment at 1-year follow-up was 17 % ( 95 % confidence interval , 2 to 30 ) in favor of the vaginal hysterectomy .\
RESULTS	No differences in quality of life and urogenital symptoms were found .\
CONCLUSIONS	The sacrospinous hysteropexy for uterine descent is associated with an earlier recovery time , more recurrent apical prolapses but no differences in functional outcomes , and quality of life .\
\
###19092465\
OBJECTIVE	To compare the efficacy and tolerability of the fixed combination of timolol maleate 0.5 % / brimonidine tartrate 0.2 % versus fixed combination of timolol maleate 0.5 % / dorzolamide 2 % in patients with elevated intraocular pressure ( IOP ) over 8 weeks .\
METHODS	This 8-week , multicentric , interventional , randomized , open-label , parallel group study was conducted at 4 centers in Brazil and 1 center in Argentina .\
METHODS	Patients with open-angle glaucoma or ocular hypertension were randomized to receive bilaterally fixed combination of brimonidine/timolol maleate 0.5 % or fixed combination of dorzolamide 2 % / timolol 0.5 % twice daily at 8:00 AM and 8:00 PM .\
METHODS	A modified diurnal tension curve ( 8:00 AM , 10:30 AM , 02:00 PM , and 4:00 PM ) followed by the water drinking test ( WDT ) , which estimates IOP peak of diurnal tension curve , were performed in the baseline and week-8 visits .\
METHODS	Adverse events data were recorded at each visit .\
RESULTS	A total of 210 patients were randomized ( brimonidine/timolol , n = 111 ; dorzolamide/timolol , n = 99 ) .\
RESULTS	Mean baseline IOP was 23.43 + / -3.22 mm Hg and 23.43 + / -4.06 mm Hg in the patients treated with brimonidine/timolol and dorzolamide/timolol , respectively ( P = 0.993 ) .\
RESULTS	Mean diurnal IOP reduction after 8 weeks were 7.02 + / -3.06 mm Hg and 6.91 + / -3.67 mm Hg , respectively ( P = 0.811 ) .\
RESULTS	The adjusted difference between groups ( analysis of covariance ) at week 8 was not statistically significant ( P = 0.847 ) .\
RESULTS	Mean baseline WDT peak was 27.79 + / -4.29 mm Hg in the brimonidine/timolol group and 27.68 + / -5.46 mm Hg in the dorzolamide/timolol group .\
RESULTS	After 8 weeks of treatment , mean WDT peaks were 20.94 + / -3.76 mm Hg ( P < 0.001 ) and 20.98 + / -4.19 ( P < 0.001 ) , respectively .\
RESULTS	The adjusted difference between groups ( analysis of covariance ) was not statistically significant ( P = 0.469 ) .\
RESULTS	No statistical difference in terms of adverse events was found between groups .\
CONCLUSIONS	Both fixed combinations were capable of significantly reducing the mean diurnal IOP , mean diurnal peak , and mean WDT peak after 8 weeks of treatment .\
CONCLUSIONS	Also , both fixed combinations are well tolerated with few side effects .\
\
###23492647\
OBJECTIVE	Combination therapy with angiotensin receptor blockers ( ARBs ) and calcium channel blockers or diuretics is common for hypertensive patients .\
OBJECTIVE	This study aimed to determine which combination is better for elderly hypertensive patients .\
METHODS	In this prospective , randomized , open-label trial , hypertensive outpatients aged at least 65 years who had not achieved their target blood pressure ( BP ) with standard ARB dosages were randomly assigned to receive either a fixed-dose combination of losartan ( 50mg ) and hydrochlorothiazide ( 12.5 mg ) ( ARB+D ; n = 72 ) or a combination of amlodipine ( 5mg ) and the typical dosage of ARBs ( ARB+C ; n = 68 ) to evaluate the change in the BP , laboratory values and cognitive function .\
RESULTS	At 3 months , the SBP/DBP was found to have significantly decreased from 156/8315/11mmHg to 139/7614/10mmHg in the ARB+D group and 155/8311/10mmHg to 132/7214/10mmHg in the ARB+C group .\
RESULTS	The BP reduction efficacy was greater in the ARB+C group than in the ARB+D group .\
RESULTS	At 6 months , the SBP/DBP reached the same level in both groups .\
RESULTS	At 12 months , the urine albumin/creatinine ratio was significantly decreased from the geometric mean of 17.1 to 9.6 mg/g in the ARB+D group , whereas it was increased from 19.8 to 23.7 mg/g in the ARB+C group .\
RESULTS	Conversely , the estimated glomerular filtration rate tended to show a decrease in the ARB+D group .\
RESULTS	There was no significant difference in mini-mental state examination after 1 year .\
CONCLUSIONS	ARB + amlodipine ( 5mg ) yielded a greater BP reduction , whereas ARB+HCTZ ( 12.5 mg ) resulted in a greater reduction in the albuminuria , suggesting that each combination therapy is advantageous in a different manner for elderly hypertensive patients .\
\
###19696679\
OBJECTIVE	The aim of this study was to compare the efficacy of pretreatment with paracetamol 0.5 mg kg ( -1 ) , 1 mg kg ( -1 ) , 2 mg kg ( -1 ) and lidocaine 0.5 mg kg ( -1 ) for prevention of propofol induced pain .\
METHODS	In this double-blind , placebo-controlled study , 250 adult patients ASA I or II , scheduled to undergo elective surgery , were randomly assigned into five groups of 50 each .\
METHODS	Group P0 .5 , group P1 and group P2 received 0.5 , 1 and 2 mg kg ( -1 ) paracetamol respectively ; group L received 0.5 mg kg ( -1 ) lidocaine ; and the control group , group C , received isotonic saline pretreatment in the dorsum of the hand , followed by propofol 1 min later .\
METHODS	A blinded researcher assessed the patient 's pain level via a four-point scale .\
RESULTS	There were no significant differences in patient characteristics among the groups .\
RESULTS	The incidence of propofol injection pain in all treatment groups was significantly lower than in the control group ( P < 0.001 ) .\
RESULTS	When the paracetamol 0.5 mg kg ( -1 ) group was compared with both the paracetamol 1 mg kg ( -1 ) group ( P < 0.01 ) and the paracetamol 2 mg kg ( -1 ) group ( P < 0.001 ) , significant differences were observed .\
RESULTS	In the lidocaine 0.5 mg kg ( -1 ) group propofol injection pain was significantly reduced compared with the paracetamol 0.5 mg kg ( -1 ) group ( P < 0.01 ) .\
RESULTS	However , in the paracetamol 2 mg kg ( -1 ) group pain was more significantly reduced than in the lidocaine 0.5 mg kg ( -1 ) group ( P < 0.001 ) .\
RESULTS	In the paracetamol 2 mg kg ( -1 ) group the incidence of pain was significantly less than in paracetamol 1 mg kg ( -1 ) group ( P < 0.001 ) .\
CONCLUSIONS	When given as venous retention pretreatments 1 min before propofol , paracetamol 1 mg kg ( -1 ) and lidocaine 0.5 mg kg ( -1 ) were equally effective in attenuating pain during intravenous ( i.v. ) injection of propofol whereas pretreatment with paracetamol 2 mg kg ( -1 ) was shown to be the most effective treatment .\
\
###22920273\
BACKGROUND	We describe the rationale and protocol for a randomized noninferiority controlled trial ( RCT ) to determine if the Flexi-T380 ( + ) copper intrauterine contraceptive device ( IUD ) is comparable in terms of effectiveness and expulsion rates to the most common Canadian IUD currently in use , NovaT-200 , when placed immediately after a first-trimester abortion .\
METHODS	Consenting women choosing to use an IUD after an abortion for a pregnancy of less than 12 weeks of gestation will be randomized to device-type groups to receive immediate post-abortion placement of either a Flexi-T380 ( + ) IUD , a device for which no current evidence on expulsion or effectiveness rates is available , or the Nova-T200 IUD , the only other brand of copper IUD available in Canada at the time of study initiation .\
METHODS	The primary outcome measure is IUD expulsion rate at 1 year .\
METHODS	Secondary outcomes include : pregnancy rate , method continuation rate , complication rates ( infection , perforation ) , and satisfaction with contraceptive method .\
METHODS	A non-intervention group of consenting women choosing a range of other post-abortion contraception methods , including no contraception , will be included for comparison of secondary outcomes .\
METHODS	Web-based contraception satisfaction questionnaires , clinical records , and government-linked health administrative databases will be used to assess primary and secondary outcomes .\
CONCLUSIONS	The RCT design , combined with access to clinical records at all provincial abortion clinics , and to information in provincial single-payer linked administrative health databases , birth registry , and hospital records , offers a unique opportunity to determine if a novel IUD has a comparable expulsion rate to that of the current standard IUD in Canada , in addition to the first opportunity to determine pregnancy rate and method satisfaction at 1 year post-abortion for women choosing a range of post-abortion contraceptive options .\
CONCLUSIONS	We highlight considerations of design , implementation , and evaluation of the first trial to provide rigorous evidence for the effectiveness of current Canadian IUDs when inserted after first-trimester abortion .\
BACKGROUND	ClinicalTrials.gov Identifier NCT01174225 .\
\
###24217302\
OBJECTIVE	Levosimendan has anti-ischaemic effects , improves myocardial contractility and increases systemic , pulmonary and coronary vasodilatation .\
OBJECTIVE	These properties suggest potential advantages in high-risk cardiac valve surgery patients where cardioprotection would be valuable .\
OBJECTIVE	The present study investigated the peri-operative haemodynamic effects of prophylactic levosimendan infusion in cardiac valve surgery patients with low ejection fraction and/or severe pulmonary arterial hypertension .\
METHODS	Between May 2006 and July 2007 , 20 consecutive patients with severe pulmonary arterial hypertension ( systolic pulmonary artery pressure 60 mmHg ) and/or low ejection fraction ( < 50 % ) who underwent valve surgery in our clinic were included in the study and randomised into two groups .\
METHODS	Levosimendan was administered to 10 patients in group I and not to the 10 patients in the control group .\
METHODS	Cardiac output ( CO ) , cardiac index ( CI ) , systemic vascular resistance ( SVR ) , pulmonary vascular resistance ( PVR ) and mean pulmonary artery pressure ( MPAP ) were recorded for each patient preoperatively and for 24 hours following the operation .\
RESULTS	CO and CI values were higher in the levosimendan group during the study period ( p < 0.05 ) .\
RESULTS	MPAP and PVR values were significantly lower in the levosimendan group for the 24-hour period ( p < 0.05 ) and SVR values were significantly lower after 24 hours in both groups .\
RESULTS	When clinical results were considered , no difference in favour of levosimendan was detected regarding the mortality and morbidity rates between the groups .\
CONCLUSIONS	Levosimendan improved the haemodynamics in cardiac valve surgery patients with low ejection fraction and/or severe pulmonary arterial hypertension , and facilitated weaning from cardiopulmonary bypass in such high-risk patients when started as a prophylactic agent .\
\
###18193495\
OBJECTIVE	To assess the safety of the candidate microbicide Carraguard gel in HIV-positive women and men .\
METHODS	A randomized , placebo-controlled , triple-blinded clinical trial of Carraguard gel when applied vaginally once per day for 14 intermenstrual days by sexually abstinent and sexually active HIV-positive women ; and when applied directly to the penis once per day for 7 days by sexually abstinent HIV-positive men .\
METHODS	In each cohort ( n = 20 per cohort ) , participants were randomized to Carraguard , methylcellulose placebo , or no product ( 1:1:1 ) .\
METHODS	In addition to traditional microbicide trial safety endpoints , the effects of microbicide use on vaginal shedding of HIV-1 RNA and markers of genital inflammation , epithelial sloughing , and microhemorrhage were also explored .\
RESULTS	Gel compliance was high in both gel-use groups in the 3 cohorts .\
RESULTS	Carraguard use was not associated with abnormal genital findings , other abnormal clinical findings , markers of genital inflammation , epithelial sloughing or microhemorrhage , or self-reported symptoms in women and men , or with abnormal vaginal flora or genital shedding of HIV-1 RNA in women .\
RESULTS	Adverse events were mostly mild , not attributed to gel use , and similarly distributed between groups .\
CONCLUSIONS	Once-daily use of Carraguard for 7 to 14 days appeared to be safe in HIV-positive women and men .\
\
###9270638\
OBJECTIVE	This study investigated the role of preoperative chemotherapy in squamous cell cancer of the esophagus .\
METHODS	A prospective randomized trial was undertaken in 147 patients : 74 received preoperative chemotherapy comprising cisplatin and 5-fluorouracil and 73 had surgical therapy alone .\
METHODS	End points were cancer and therapy-related deaths .\
RESULTS	Sixty-six patients ( 89 % ) in the chemotherapy group underwent resection compared with 69 ( 95 % ) in the control group ( p = not significant ) .\
RESULTS	Of the 60 patients who had resection after completing the chemotherapy program , 35 ( 58 % ) had a significant response , of whom four ( 6.7 % ) had a complete pathologic response .\
RESULTS	Postoperative mortality rates were 8.3 % and 8.7 % in the chemotherapy and control groups , respectively ( p = not significant ) .\
RESULTS	Significant downstaging was evident with chemotherapy ; curative resections were possible in 67 % of these patients compared with 35 % in the control group ( p = 0.0003 ) .\
RESULTS	T3 and T4 tumors were found in 67 % and 91 % of the chemotherapy and control groups , respectively ( p = 0.0002 ) .\
RESULTS	The respective figures for N1 disease were 70 % and 88 % ( p = 0.009 ) .\
RESULTS	An intent-to-treat analysis of survival showed no significant difference between the two groups .\
RESULTS	Median survivals were 16.8 and 13 months , respectively ( p = 0.17 ) .\
RESULTS	Of those who completed the chemotherapy and resection , responders fared better than control patients .\
RESULTS	Median survivals were 42.2 months and 13.8 months , respectively ( p = 0.003 ) .\
RESULTS	Median survival ( 8.3 months ) was worse for nonresponders than for control patients ( p = 0.03 ) .\
RESULTS	The recurrence pattern suggested a significant reduction in locoregional disease with chemotherapy .\
CONCLUSIONS	Preoperative chemotherapy was safe and resulted in significant downstaging and an increased likelihood of curative resection .\
CONCLUSIONS	Survival was not better than that in the surgery-alone group , but responders did fare better than nonresponders .\
\
###10081852\
OBJECTIVE	We report the 5-year followup of a randomized comparison of mitomycin C and bacillus Calmette-Guerin ( BCG ) in patients with superficial bladder carcinoma .\
OBJECTIVE	Recurrence , progression and survival rates , crossover results , prognostic factors and long-term side effects were analyzed .\
METHODS	A total of 261 patients were enrolled in the study , and the inclusion criteria were primary Tis , dysplasia G2 , T1 G3 and multiple recurrent Ta/T1 G1-2 disease .\
METHODS	Intravesical instillations of 40 mg .\
METHODS	mitomycin C and 120 mg .\
METHODS	Pasteur BCG , Danish strain 1331 , were given for 2 years .\
RESULTS	After a median followup of 64 months 101 of the 250 evaluable patients ( 42 % ) were disease-free .\
RESULTS	A significant difference was noted in disease-free survival with BCG ( p = 0.04 ) , which was most pronounced for stage Tis disease .\
RESULTS	No difference in tumor progression , or crude or corrected survival was found between the 2 arms .\
RESULTS	Crossover treatment was successful in 39 % of patients with second line BCG and 19 % with second line mitomycin C. Independent risk factors for progression were initial p53 status and stage .\
RESULTS	Only the completion of treatment was predictive of outcome for patients treated with BCG .\
RESULTS	Bladder shrinkage occurred in 2.4 % of patients .\
CONCLUSIONS	Therapy with BCG was superior to mitomycin C for recurrence prophylaxis but no difference was found for progression and survival .\
\
###21168923\
OBJECTIVE	To compare the effects of preincisional peritonsillar infiltration of levobupivacaine and bupivacaine on post-tonsillectomy pain in children .\
METHODS	Sixty children undergoing elective tonsillectomy or adenotonsillectomy were randomly allocated into three groups before tonsillectomy : peritonsillar infiltrations with 0.25 % levobupivacaine with 1:200,000 epinephrine ( group levobupivacaine , n = 20 ) , 0.25 % bupivacaine with 1:200,000 epinephrine ( group bupivacaine , n = 20 ) , and normal saline ( group saline , n = 20 ) were applied .\
METHODS	Pain was evaluated by using a modified Children 's Hospital of Eastern Ontario Pain Scale ( mCHEOPS ) .\
METHODS	Choice of additional analgesic was acetaminophen for all patients .\
RESULTS	mCHEOPS values at 0th ( immediately ) and 30th minute after arrival the PACU were lower in both the local anesthetics groups than the saline group ( p < 0.001 , p < 0.01 for the group levobupivacaine ; p < 0.001 , p < 0.05 for the group bupivacaine , respectively ) .\
RESULTS	In addition , mCHEOPS values at 1st hour in the ward was lower in the group bupivacaine when compared to the group saline ( p < 0.05 ) .\
RESULTS	Analgesic requirements and the time to first analgesia required , were also significantly different between the local anesthetic and saline groups ( p < 0.05 for both local anesthetics groups ) .\
RESULTS	Time to first mobilization was shorter in both local anesthetic groups when compared to the saline group ( p < 0.05 for both local anesthetic groups ) .\
CONCLUSIONS	Preincisional peritonsillar infiltration with levobupivacaine or bupivacaine before tonsillectomy , are effective than saline , in reducing early post-tonsillectomy pain , where as bupivacaine had slightly longer effect .\
CONCLUSIONS	Compared to saline , with both anesthetic infiltrations , lesser medication for analgesia is required .\
CONCLUSIONS	The clinical trial registration number ( Research Ethics Committee of Medical Faculty , Uludag University ) : 2008-4/36 , 19 February 2008 .\
\
###14737055\
BACKGROUND	Current guidelines do not recommend G-CSF for patients with risk factors for neutropenia .\
METHODS	One-hundred patients undergoing chemotherapy were randomized to treatment with G-CSF at 5 Kg/kg for established febrile neutropenia ( ANC < 1000/microl ) ( Group A ) or G-CSF at 263 Kg/day if ANC was 1500/microl or less on the day of the expected nadir , with the duration of treatment determined by the severity of neutropenia ( Group B ) .\
RESULTS	The number of doses of G-CSF was similar in the two groups .\
RESULTS	There were 34 cases of febrile neutropenia in Group A , but none in Group B ( p = 0.0001 ) .\
RESULTS	Hospital admission for febrile neutropenia , antibiotic use and delays in chemotherapy were all significantly more common in Group A. Total direct costs were estimated to be 66 , 646 for Group A and 47 , 119 for Group B.\
CONCLUSIONS	Tailoring treatment does not increase G-CSF use , but significantly reduces febrile neutropenia and treatment delays and lowers direct costs .\
\
###21348211\
OBJECTIVE	In cesarean section , the optimal dose of oxytocin to reduce the risk of hemorrhage with the least risk of adverse effects has yet to be defined .\
OBJECTIVE	We studied the effects of using 2 different doses of oxytocin in women undergoing elective cesarean section under spinal anesthesia .\
OBJECTIVE	The women had had no prior labor .\
METHODS	Randomized multicenter trial enrolling 104 patients classified as ASA 1 .\
METHODS	Following fetal extraction and coinciding with umbilical cord clamping , a group of 52 women received 1 IU of oxytocin followed by an infusion of 2.5 IU x h ( -1 ) ; a second group of 52 women received a continuous infusion of 20 IU at a rate of 700 mlU x min ( -1 ) followed by 10 IU x min ( -1 ) .\
METHODS	We compared uterine contractility ( assessed as absent , moderate , satisfactory ) , postoperative vaginal bleeding ( absent , light , moderate , heavy ) , hemodynamics , and adverse effects after administration of oxytocin and fetal extraction ( electrocardiographic abnormalities , nausea , vomiting , discomfort , headache , blushing , trembling , chills , or chest pain ) .\
RESULTS	No significant between-group differences in patient , obstetric , or anesthetic variables were detected .\
RESULTS	Uterine contraction was satisfactory in over 90 % of the patients in both groups on initial assessment during surgery .\
RESULTS	After surgery , vaginal bleeding was absent or light in over 90 % of the women .\
RESULTS	No significant differences in adverse events were detected between groups .\
CONCLUSIONS	The incidence of obstetric bleeding is not higher when a lower dose of oxytocin is used ; the rate of postoperative adverse events also does not increase .\
\
###21372003\
OBJECTIVE	The Gout Impact Scale ( GIS ) is a gout-specific quality of life instrument that assesses impact of gout during an attack and impact of overall gout .\
OBJECTIVE	The GIS has five scales and each is scored from 0 to 100 ( worse health ) .\
OBJECTIVE	Our objective was to assess minimally important differences ( MIDs ) for the GIS administered in a randomized controlled trial ( RCT ) assessing rilonacept vs placebo for prevention of gout flares during initiation of allopurinol therapy .\
METHODS	Trial subjects ( n = 83 ) included those with two or more gout flares ( self-reported ) in the past year .\
METHODS	Of these , 73 had data for Weeks 8 vs 4 and formed the MID analysis group and were analysed irrespective of the treatment assignment .\
METHODS	Subjects completed the GIS and seven patient-reported anchors .\
METHODS	Subjects with a one-step change ( e.g. from very poor to poor ) were considered as the MID group for each anchor .\
METHODS	The mean change in GIS scores and effect size ( ES ) was calculated for each anchor 's MID group .\
METHODS	The average of these created the overall summary MID statistics for each GIS .\
METHODS	An ES of 0.2-0 .5 was considered to represent MID estimates .\
METHODS	Results .\
METHODS	Trial subjects ( n = 73 ) were males ( 96.0 % ) , White ( 90.4 % ) , with mean age of 50.5 years and serum uric acid of 9.0 mg/dl .\
METHODS	The mean change score for the MID improvement group for scales ranged from -5.24 to -7.61 ( 0-100 scale ) .\
METHODS	The ES for the MID improvement group for the four scales ranged from 0.22 to 0.38 .\
CONCLUSIONS	The MID estimates for GIS scales are between 5 and 8 points ( 0-100 scale ) .\
CONCLUSIONS	This information can aid in interpreting the GIS results in future gout RCTs .\
CONCLUSIONS	Trial Registration .\
CONCLUSIONS	Clinicaltrials.gov , www.clinicaltrials.gov , NCT00610363 .\
\
###21846962\
BACKGROUND	Around the world , the timing of referral of chronic obstructive pulmonary disease ( COPD ) patients for pulmonary rehabilitation differs from immediately after exacerbation ( early ) to later on when patients are in a stable state ( late ) .\
BACKGROUND	There are no trials comparing the different time points of referral for pulmonary rehabilitation .\
OBJECTIVE	Our aim was to compare the effects of early and late pulmonary rehabilitation on exacerbation rates and health-related quality of life ( HRQOL ) in COPD patients with exacerbations .\
METHODS	We randomized COPD patients ( Global Initiative for Chronic Obstructive Lung Disease stages II-IV ) with a recent exacerbation to early ( within 2 weeks ) or late pulmonary rehabilitation ( starting 6 months after randomization and in a stable state ) .\
METHODS	The primary outcome was the exacerbation rate over 18 months , and secondary outcomes included HRQOL and mortality .\
METHODS	We used multivariate analyses and an intention-to-treat analysis approach .\
RESULTS	We randomized 36 patients to pulmonary rehabilitation .\
RESULTS	On average , patients with early rehabilitation ( n = 19 ) had 2.61 ( SD 2.96 ) exacerbations requiring systemic corticosteroids and/or antibiotics , compared to 2.77 ( SD 3.41 ) in patients with late rehabilitation ( adjusted incidence rate ratio 0.83 , 95 % confidence interval 0.43-1 .63 ; p = 0.60 ) .\
RESULTS	Over the 18-month period , patients with late rehabilitation experienced more dyspnea ( difference on Chronic Respiratory Questionnaire dyspnea domain 0.74 and on the Medical Research Council dyspnea scale 0.37 ) , but neither these differences nor any difference in HRQOL domains reached statistical significance .\
CONCLUSIONS	We did not find any statistically significant differences between early and late pulmonary rehabilitation .\
CONCLUSIONS	However , our trial indicates that early rehabilitation may lead to faster recovery of HRQOL after exacerbations compared to rehabilitation later on when patients are in a stable state .\
\
###20683279\
OBJECTIVE	Ecchymosis is commonly encountered after upper eyelid blepharoplasty .\
OBJECTIVE	The use of homeopathic preparations of Arnica montana , a flowering herb , has been advocated by physicians , patients , and manufacturers for reduction of postsurgical ecchymosis .\
OBJECTIVE	The authors evaluate its efficacy after upper eyelid blepharoplasty .\
METHODS	A prospective , placebo-controlled , double-blind study was performed in which patients were randomly assigned to the administration of homeopathic A. montana or placebo concurrent with unilateral upper eyelid blepharoplasty followed by contralateral treatment at least 1 month later .\
METHODS	Ecchymosis was evaluated at days 3 and 7 by rank order of severity and measurement of surface area of observable ecchymosis .\
RESULTS	There was no statistically significant difference in area of ecchymosis or rank order of ecchymosis severity for days 3 and 7 after treatment with A. montana versus placebo .\
RESULTS	Additionally , there was no difference in ease of recovery per patient report , and there was no difference in the rate of ecchymosis resolution .\
CONCLUSIONS	The authors find no evidence that homeopathic A. montana , as used in this study , is beneficial in the reduction or the resolution of ecchymosis after upper eyelid blepharoplasty .\
\
###9609267\
OBJECTIVE	To determine whether postmenopausal oestrogen replacement therapy affects carotid artery pulsatility index .\
METHODS	A prospective double-blind placebo controlled trial .\
METHODS	University associated teaching hospital .\
METHODS	Twenty-eight postmenopausal women who were more than 12 months postmenopausal and who had not taken exogenous oestrogen .\
METHODS	Independent randomisation to receive oral oestradiol ( 2 mg daily ) or placebo for 20 to 24 weeks .\
METHODS	Internal carotid artery Doppler pulsatility index , measured within one centimetre of the carotid bifurcation .\
RESULTS	Replicate data were available from 27 women .\
RESULTS	The mean pulsatility index decreased by -0.11 in 15 women receiving oestradiol , compared with a mean rise of 0.05 in the 12 women who received placebo ( P = 0.006 , 95 % CI for treatment difference 0.06-0 .31 ) .\
CONCLUSIONS	Oestrogen replacement decreases postmenopausal carotid artery pulsatility index , probably reflecting decreased peripheral vascular resistance .\
CONCLUSIONS	This is a further mechanism whereby hormone replacement therapy may impart cardiovascular protection .\
\
###22737876\
OBJECTIVE	To observe therapy efficacy of external auditory canal eczema by deeply injecting compound betamethasone and benzathine penicillin into patients muscles .\
METHODS	Sixty patients were randomly divided into two groups .\
METHODS	In the treatment group 30 patients were deeply injected compound betamethasone injection 1 ml and benzathine penicillin 1 200 000 U into muscles on their hips both sides one times .\
METHODS	In the control group 30 patients were given desloratadine 5 mg orally one times a day and amoxicillin capsules 0.5 mg orally three times a day , both kinds of medicine were continuously taken for one week .\
METHODS	No other medication was used during the treatment of two groups , keeping skin clean and dry , and judge therapy efficacy after one week .\
RESULTS	The cure rate was 60.00 % and the total efficiency was 96.67 % in the treatment group ; the cure rate was 26.67 % and the total efficiency was 73.33 % in the control group .\
RESULTS	Compare with cure rate of two groups , chi2 = 6.67 , P < 0.01 , in which there was significant difference .\
RESULTS	Compare with total efficiency of two groups , chi2 = 4.71 , P < 0.05 , in which there was also significant difference .\
RESULTS	The therapy effect started in two hours quickly and in three days slowly in the treatment group , an average of 0.5 days .\
RESULTS	The therapy effect started in two days quickly and in five days slowly in the control group , an average of 2.5 days .\
CONCLUSIONS	The method of the treatment group is simple , quick , effective and without adverse reaction .\
\
###22056151\
OBJECTIVE	To explore the relationship between sleep quality and common measures of nutritional status in the Hemodialysis ( HEMO ) Study cohort .\
OBJECTIVE	To investigate sleep quality scores based on longitudinal changes in measures of nutritional status , adjusting for case mix , lifestyle , and comorbidity factors .\
METHODS	Secondary analysis of the HEMO Study data .\
METHODS	A 7-year , prospective , multicenter , randomized clinical trial in maintenance hemodialysis patients .\
METHODS	Eighteen hundred forty-six patients aged between 18 and 80 years were randomized ; 1,803 ( 97.7 % ) completed the Kidney Disease Quality of Life Long Form ( KDQOL-LF ) at baseline .\
METHODS	Mean age was 58 years , 44 % were male , 64 % were Black , 37 % had diabetes , and 32 % had hypertension ; mean duration of dialysis was 3.8 years .\
METHODS	The univariate and multivariate relationships of measures of nutritional status ( i.e. , serum albumin , serum creatinine , postdialysis weight , body mass index , dietary protein and energy intake , and assessment of appetite ) and sleep quality assessed using the sleep subscale from the KDQOL-LF .\
RESULTS	In univariate analysis , sleep quality score decreased significantly in a linear fashion as appetite rating decreased from very good to very poor on both dialysis days ( 63.6 21.8 to 43.6 22.9 , P < .0001 ) and nondialysis days ( 63.2 21.6 to 40.7 25.7 , P < .0001 ) , with higher scores reflecting better sleep quality .\
RESULTS	In multivariable analysis , serum creatinine was the only laboratory variable that was significantly associated with sleep quality score ( = 0.49 , P = .0004 ) .\
RESULTS	Poorer appetite on both dialysis days ( = -1.5 , P < .0001 ) and nondialysis days ( = -1.7 , P < .0001 ) was associated with poor sleep quality .\
CONCLUSIONS	Self-reported sleep quality was associated with appetite and serum creatinine .\
CONCLUSIONS	A simple questionnaire to assess sleep disorders in dialysis patients should be administered routinely to detect those patients at risk of sleep complaints .\
CONCLUSIONS	However , further studies are needed to determine whether improving sleep quality , directly or indirectly , would improve morbidity and mortality .\
\
###12498843\
OBJECTIVE	To evaluate the postoperative outcomes in uveitic eyes after phacoemulsification and posterior chamber intraocular lens ( IOL ) implantation .\
METHODS	Multicenter ( 19 ) international study .\
METHODS	This prospective randomized comparative interventional case series comprised 140 eyes of 140 patients who had phacoemulsification and implantation of IOLs of various materials : hydrophobic acrylic ( n = 48 ) , silicone ( n = 44 ) , poly ( methyl methacrylate ) ( PMMA ) ( n = 26 ) , or heparin-surface-modified PMMA ( HSM PMMA ) ( n = 22 ) .\
METHODS	Preoperative and postoperative grading and control of intraocular inflammation were performed .\
METHODS	Clinically significant observations , visual outcomes , and the incidence of postoperative complications were recorded .\
RESULTS	At the final follow-up , 64 eyes ( 46.3 % ) had a best corrected visual acuity of 20/40 or better , an improvement that was highly significant ( P < .0001 ) .\
RESULTS	One day after surgery , the acrylic group had the lowest inflammation values and the silicone group the highest ( P = .02 ) .\
RESULTS	The acrylic group continued to have the lowest inflammation grade values until the 3-month follow-up .\
RESULTS	The acrylic and HSM PMMA groups had the lowest incidence of relapses .\
RESULTS	Posterior capsule opacification developed in 48 eyes ( 34.2 % ) , with the highest incidence in the silicone group .\
CONCLUSIONS	Phacoemulsification with IOL implantation in selected uveitic eyes was safe and effective .\
CONCLUSIONS	Acrylic IOLs provided a better visual outcome and lower complication rate than IOLs of other materials .\
\
###11120421\
BACKGROUND	A randomized , double-blind , multi-center trial was started to compare the severity of extrapyramidal symptoms ( EPS ) during risperidone and haloperidol treatment in schizophrenic patients who had disturbing EPS during their previous neuroleptic treatment .\
BACKGROUND	Additional objectives of this trial were comparing the antipsychotic effectiveness of the two treatments and the use of antiparkinsonian medication .\
METHODS	Effects of flexible doses of risperidone and haloperidol were compared in 77 psychotic patients ( 83 % with chronic schizophrenia ) with disturbing neuroleptic-induced EPS ( risperidone 40 patients , haloperidol 37 ) .\
METHODS	The trial was completed by 47 patients : 25 in the risperidone group ( 12 women , 13 men ) , and 22 in the haloperidol group ( 10 women , 12 men ) .\
RESULTS	An adequate antipsychotic effect was obtained in most patients by both treatments .\
RESULTS	The primary aim of this trial was comparing parkinsonism measured with the extrapyramidal syndrome rating scale ( ESRS ) during treatment with risperidone and haloperidol .\
RESULTS	Two primary parameters were selected : the change from baseline to the worst score during treatment of ESRS II ( parkinsonism ) and ESRS VI ( clinical global impression of severity of parkinsonism ) .\
RESULTS	The CGI of severity of parkinsonism was better with risperidone ( P = 0.025 ) , while the parkinsonism total score tended to be better with risperidone ( P < 0.10 ) .\
RESULTS	Before the double-blind treatment , 34 ( of the 77 ) had used antiparkinson medication ( risperidone 18 , haloperidol 16 ) .\
RESULTS	During the double-blind treatment phase , 21 patients had used antiparkinson medication ( risperidone 11 , haloperidol 10 ) .\
RESULTS	The larger reduction of parkinsonism in the risperidone group was not due to a difference in the use of anti-parkinsonian medication .\
CONCLUSIONS	In this group of schizophrenic patients with disturbing EPS during previous neuroleptic treatment , a stronger reduction of parkinsonism was observed with risperidone than with haloperidol .\
\
###24286966\
OBJECTIVE	This study examined the relationships between treatment fidelity and treatment outcomes in a community-based trial of a 12-Step Facilitation ( TSF ) intervention .\
METHODS	In a prior multi-site randomized clinical trial , 234 participants in 10 outpatient drug treatment clinics were assigned to receive the Stimulant Abuser Groups to Engage in 12-Step ( STAGE-12 ) intervention .\
METHODS	A secondary analysis reviewed and coded all STAGE-12 sessions for fidelity to the protocol , using the Twelve Step Facilitation Adherence Competence Empathy Scale ( TSF ACES ) .\
METHODS	Linear mixed-effects models tested the relationship between three fidelity measures ( adherence , competence , empathy ) and six treatment outcomes ( number of days of drug use and five Addiction Severity Index ( ASI ) composite scores ) measured at 3 months post-baseline .\
RESULTS	Adherence , competence and empathy were robustly associated with improved employment status at follow up .\
RESULTS	Empathy was inversely associated with drug use , as was competence in a non-significant trend ( p = .06 ) .\
RESULTS	Testing individual ASI drug composite score items suggested that greater competence was associated with fewer days of drug use and , at the same time , with an increased sense of being troubled or bothered by drug use .\
CONCLUSIONS	Greater competence and empathy in the delivery of a TSF intervention were associated with better drug use and employment outcomes , while adherence was associated with employment outcomes only .\
CONCLUSIONS	Higher therapist competence was associated with lower self-report drug use , and also associated with greater self-report concern about drug use .\
CONCLUSIONS	The nature of TSF intervention may promote high levels of concern about drug use even when actual use is low .\
\
###24617605\
OBJECTIVE	Rosuvastatin and pitavastatin have been proposed as probe substrates for the organic anion-transporting polypeptide ( OATP ) 1B , but clinical data on their relative sensitivity and selectivity to OATP1B inhibitors are lacking .\
OBJECTIVE	A clinical study was therefore conducted to determine their relative suitability as OATP1B probes using single oral ( PO ) and intravenous ( IV ) doses of the OATP1B inhibitor rifampicin , accompanied by a comprehensive in vitro assessment of rifampicin inhibitory potential on statin transporters .\
METHODS	The clinical study comprised of two separate panels of eight healthy subjects .\
METHODS	In each panel , subjects were randomized to receive a single oral dose of rosuvastatin ( 5mg ) or pitavastatin ( 1mg ) administered alone , concomitantly with rifampicin ( 600mg ) PO or IV .\
METHODS	The in vitro transporter studies were performed using hepatocytes and recombinant expression systems .\
RESULTS	Rifampicin markedly increased exposures of both statins , with greater differential increases after POvs.IV rifampicin only for rosuvastatin .\
RESULTS	The magnitudes of the increases in area under the plasma concentration-time curve were 5.7 - and 7.6-fold for pitavastatin and 4.4 - and 3.3-fold for rosuvastatin , after PO and IV rifampicin , respectively .\
RESULTS	In vitro studies showed that rifampicin was an inhibitor of OATP1B1 and OATP1B3 , breast cancer resistance protein and multidrug resistance protein 2 , but not of organic anion transporter 3 .\
CONCLUSIONS	The results indicate that pitavastatin is a more sensitive and selective and thus preferred clinical OATP1B probe substrate than rosuvastatin , and that a single IV dose of rifampicin is a more selective OATP1B inhibitor than a PO dose .\
\
###23155151\
BACKGROUND	Boceprevir represents a new treatment option for hepatitis C ( HCV ) - infected patients , including those with HCV/human immunodeficiency virus coinfection ; however , little is known about pharmacokinetic interactions between boceprevir and antiretroviral drugs .\
METHODS	A randomized , open-label study to assess the pharmacokinetic interactions between boceprevir and ritonavir-boosted protease inhibitors ( PI/r ) was conducted in 39 healthy adults .\
METHODS	Subjects received boceprevir ( 800 mg , 3 times daily ) for 6 days and then received PI/r as follows : atazanavir ( ATV ) 300 mg once daily , lopinavir ( LPV ) 400 mg twice daily , or darunavir ( DRV ) 600 mg twice daily , each with ritonavir ( RTV ) 100 mg on days 10-31 , plus concomitant boceprevir on days 25-31 .\
RESULTS	Boceprevir decreased the exposure of all PI/r , with area under the concentration-time curve [ AUC ] from time 0 to the time of the last measurable sample geometric mean ratios of 0.65 ( 90 % confidence interval [ CI ] , .55 -.78 ) for ATV/r ; 0.66 ( 90 % CI , .60 -.72 ) for LPV/r , and 0.56 ( 90 % CI , .51 -.61 ) for DRV/r .\
RESULTS	Coadministration with boceprevir decreased RTV AUC during a dosing interval ( AUC ( ) ) by 22 % -36 % .\
RESULTS	ATV/r did not significantly affect boceprevir exposure , but boceprevir AUC ( ) was reduced by 45 % and 32 % when coadministered with LPV/r and DRV/r , respectively .\
RESULTS	Overall , treatments were well tolerated with no unexpected adverse events .\
CONCLUSIONS	Concomitant administration of boceprevir with PI/r resulted in reduced exposures of PI and boceprevir .\
CONCLUSIONS	These drug-drug interactions may reduce the effectiveness of PI/r and/or boceprevir when coadministered .\
\
###22512875\
BACKGROUND	Sunscreens absorb ultraviolet B ( UVB ) and it is a major concern that sunscreen use may lead to vitamin D deficiency .\
OBJECTIVE	To investigate the relation between the amount of sunscreen applied and the vitamin D serum level in humans after UVB exposure under controlled conditions .\
METHODS	Thirty-seven healthy volunteers with fair skin types were randomized to receive an inorganic sunscreen with sun protection factor ( SPF ) 8 of 0 mg cm ( -2 ) , 0.5 mg cm ( -2 ) , 1 mg cm ( -2 ) , 1.5 mg cm ( -2 ) , or 2 mg cm ( -2 ) thickness on the upper body , approximately 25 % of the body area .\
METHODS	Participants were irradiated with a fixed UVB dose of 3 standard erythema doses 20 min after sunscreen application .\
METHODS	This procedure was repeated four times with a 2 - to 3-day interval .\
METHODS	Blood samples were drawn before the first irradiation and 3 days after the last to determine the serum vitamin D level expressed as 25-hydroxyvitamin D ( 3 ) [ 25 ( OH ) D ] .\
RESULTS	The vitamin D serum level increased in an exponential manner with decreasing thickness of sunscreen layer in response to UVB exposure .\
RESULTS	For all thicknesses of sunscreen , the level of 25 ( OH ) D increased significantly after irradiation ( P < 0.05 ) , except for the group treated with 2 mg cm ( -2 ) , in which the increase in 25 ( OH ) D was not statistically significant ( P = 0.16 ) .\
CONCLUSIONS	Vitamin D production increases exponentially when thinner sunscreen layers than recommended are applied ( < 2 mg cm ( -2 ) ) .\
CONCLUSIONS	When the amount of sunscreen and SPF advised by the World Health Organization are used , vitamin D production may be abolished .\
CONCLUSIONS	Re-evaluation of sun-protection strategies could be warranted .\
\
###17459479\
OBJECTIVE	To evaluate the efficacy of sequential intravitreal triamcinolone acetonide ( TA ) injection followed by grid laser photocoagulation for treating diabetic macular edema ( DME ) .\
METHODS	Prospective , 3-armed , randomized clinical trial .\
METHODS	One hundred eleven eyes of 111 patients with DME involving the fovea .\
METHODS	Patients were randomized to grid laser photocoagulation ( 37 eyes ) , 4 mg of intravitreal TA ( 38 eyes ) , or 4 mg of intravitreal TA combined with sequential grid laser about 1 month later ( 36 eyes ) .\
METHODS	Central foveal thickness ( CFT ) as measured by optical coherence tomography , logarithm of the minimum angle of resolution ( logMAR ) best-corrected visual acuity ( BCVA ) , and side effect profiles .\
METHODS	The 6-month results are reported .\
RESULTS	All patients completed 6 months ' follow-up .\
RESULTS	Baseline mean ( + / - standard deviation ) CFTs were 385 + / -100 microm , 396 + / -91 microm , and 424 + / -108 microm for the laser , intravitreal TA , and combined groups , respectively ( P = 0.24 ) .\
RESULTS	After treatment , significant CFT reductions were noted in both the intravitreal TA and combined groups at all follow-up visits ( P < 0.01 ) but not in the laser group .\
RESULTS	Mean CFT improved significantly to minimums of 267 + / -75 microm and 256 + / -73 microm for the intravitreal TA and combined groups , respectively , but the difference between the 3 groups was not significant at 6 months .\
RESULTS	The standardized change in macular thickening at 17 weeks was significantly greater in the combined group versus the intravitreal TA group ( P = 0.007 ) , suggesting that combined treatment might prolong the effects of intravitreal TA .\
RESULTS	Mean baseline logMAR BCVAs were 0.64 + / -0.37 , 0.72 + / -0.34 , and 0.69 + / -0.34 in the laser , intravitreal TA , and combined groups , respectively ( P = 0.67 ) .\
RESULTS	Best-corrected visual acuity improved significantly at 4 and 9 weeks for the intravitreal TA group but did not change significantly in the other 2 groups .\
RESULTS	No significant difference in BCVA was observed between the 3 groups at any time point .\
CONCLUSIONS	Contrary to the results of a recent study , combined treatment of intravitreal TA plus grid laser did not yield better CFT reduction or BCVA improvement at 6 months than intravitreal TA alone .\
CONCLUSIONS	Grid laser alone was significantly worse than the 2 other treatment modalities .\
\
###17544379\
BACKGROUND	Serotonin ( 5-HT ) plays a central role in mood regulation and impulsivity .\
BACKGROUND	We studied whether healthy men and women react differently on mood and impulsivity measures during acute tryptophan depletion ( ATD ) .\
BACKGROUND	We also studied the relative contribution of a functional length triallelic polymorphism in the promoter region of the serotonin transporter , designated 5-HTTLPR , to the behavioral responses to ATD .\
METHODS	Thirty-nine men and 44 women participated in a randomized , double-blind , parallel group ATD study .\
METHODS	Behavioral measures of impulsivity and mood were obtained .\
RESULTS	During ATD , women reported mood reduction and showed a cautious response style , which is commonly associated with depression .\
RESULTS	Men showed an impulsive response style and did not report mood reduction .\
RESULTS	The 5-HTTLPR influenced the mood response to ATD in women .\
CONCLUSIONS	Healthy men became more impulsive , whereas healthy women showed mood reduction in response to ATD .\
CONCLUSIONS	This suggests that 5-HT could be one mechanism contributing to the sex differences in the prevalence of mood and impulsivity disorders .\
CONCLUSIONS	The influence of 5-HTTLPR on mood responses in women further substantiates the relevance of this variant in the pathophysiology of at least a subgroup of patients with major depressive disorder .\
\
###19500889\
OBJECTIVE	Preoperative starvation has many undesirable effects but the minimum length of fasting is limited by gastric emptying , which may be dependent on nutrient content , viscosity and osmolarity of the feed .\
OBJECTIVE	We compared the gastric emptying of two types of preoperative metabolic preconditioning drinks [ Oral Nutritional Supplement ( ONS ) ( Fresenius Kabi , Germany ) and preOp ( Nutricia Clinical Care , UK ) ] in healthy volunteers .\
METHODS	Twenty ( 10 male , 10 female ) healthy adult volunteers were studied on 3 separate occasions in a randomised crossover manner .\
METHODS	Volunteers ingested 400 ml preOp , which is a clear carbohydrate drink ( CCD ) ( 50 g carbohydrate , 0 g protein ) , 70 g ONS ( 50 g carbohydrate and 15 g glutamine ) dissolved in water to a total volume of 400 ml ( ONS400 ) and 300 ml ( ONS300 ) .\
METHODS	Gastric emptying time was measured using magnetic resonance imaging .\
RESULTS	Mean ( 95 % CI ) T ( 50 ) and T ( 100 ) gastric emptying times for CCD were significantly lower ( p < 0.001 ) compared with ONS400 and ONS300 .\
RESULTS	T ( 50 ) was 47 ( 39-55 ) , 78 ( 69-87 ) and 81 ( 70-92 ) min for CCD , ONS400 and ONS300 respectively .\
RESULTS	Correspondingly T ( 100 ) was 94 ( 79-110 ) , 156 ( 138-173 ) and 162 ( 140-184 ) min .\
RESULTS	Residual gastric volumes returned to baseline 120 min after CCD and 180 min after ONS400 and ONS300 .\
CONCLUSIONS	The faster gastric emptying for CCD compared to ONS400 and ONS300 signifies that gastric emptying may be more dependent on nutrient load than volume or viscosity in healthy volunteers .\
CONCLUSIONS	While it is safe to give CCD 2h preoperatively , ONS400 and ONS300 should be given at least 3h preoperatively .\
\
###10710018\
OBJECTIVE	To determine the effectiveness of a safety education program , Safety City , that is designed to teach kindergarten and first grade children how to cross the street , call 911 in an emergency , and avoid strangers .\
METHODS	Kindergarten students at 10 urban elementary schools .\
METHODS	Each school was randomized to either the intervention or control group .\
METHODS	An evaluation tool was administered to all participants as a pretest .\
METHODS	The Safety City program was then presented to the intervention schools .\
METHODS	Afterward , the same evaluation tool was used as a post-test .\
METHODS	The posttest was administered to the intervention group 6 months after the Safety City program was presented .\
METHODS	The control group took the posttest 6 months after the pretest .\
METHODS	Change in individual test scores .\
RESULTS	One hundred eighty-one children completed the pretest and posttest evaluations .\
RESULTS	There was no statistical difference in the change between pretest and posttest scores of children who participated in the Safety City program and those in the control group ( crossing the street , P = .29 ; calling 911 , P = .41 ; stranger avoidance , P = .57 ) .\
CONCLUSIONS	Exposure to the Safety City program did not achieve the desired changes in safety knowledge among participants .\
CONCLUSIONS	This is most likely owing to the fact that Safety City attempts to convey a large amount of relatively complex information to young children in a brief period .\
CONCLUSIONS	We conclude that programs such as Safety City are not sufficient to teach children these behaviors .\
CONCLUSIONS	This report also emphasizes the importance of building an evaluation component into educational programs .\
\
###10794751\
BACKGROUND	In Paget disease of bone ( PD ) , serum total alkaline phosphatase ( TAP ) is a valid marker of disease activity .\
BACKGROUND	The aim of the present longitudinal study was to compare TAP with new and potentially more specific markers of bone turnover in bisphosphonate-treated patients with PD .\
METHODS	Twenty patients with active PD were studied before and after treatment with 2 mg of intravenous ibandronate over a period of 12 months .\
METHODS	TAP ( by colorimetry ) , serum bone-specific alkaline phosphatase ( BAP ; by enzyme immunoassay ) , serum osteocalcin ( OC ; by ELISA ) , serum bone sialoprotein ( BSP ; by RIA ) , and urinary total pyridinoline ( PYD ; by HPLC ) and deoxypyridinoline ( DPD ; by HPLC ) were measured as markers of bone turnover .\
RESULTS	Before treatment , TAP , BAP , and BSP were increased in all 20 patients , whereas OC was increased in 10 , PYD in 13 , and DPD in 15 patients .\
RESULTS	Three months post treatment , nine patients showed normalized TAP values , and a > / = 25 % re-increase ( i.e. , relapse ) was observed in all patients after 12 months .\
RESULTS	A normalization of BAP was achieved in six patients only .\
RESULTS	No significant changes were found for OC .\
RESULTS	BSP was decreased significantly at 24 h , and DPD at 48 h post treatment .\
RESULTS	A normalization of BSP was found in 8 , of PYD in 18 , and of DPD in 16 cases .\
RESULTS	Both PYD and DPD increased significantly from 9 months post treatment onward .\
CONCLUSIONS	Most markers of bone turnover show similar long-term changes after treatment of active PD with ibandronate .\
CONCLUSIONS	With regard to cost-effectiveness and assay performance , TAP remains the marker of choice in therapeutic monitoring of PD .\
CONCLUSIONS	However , more specific markers may improve the biochemical assessment of PD in certain situations .\
\
###22472037\
BACKGROUND	Studies have shown that pistachios can improve blood lipid profiles in subjects with moderate hypercholesterolemia which could reduce the risk of cardiovascular disease .\
BACKGROUND	However , there is also a widely perceived view that eating nuts can lead to body weight gain due to their high fat content .\
OBJECTIVE	To investigate the impact of different dosages of pistachios on body weight , blood pressure , blood lipids , blood glucose and insulin in subjects with metabolic syndrome .\
METHODS	Ninety subjects with metabolic syndrome ( consistent with 2005 International Diabetes Federation metabolic syndrome standard without diabetes ) were enrolled in three endocrinology outpatient clinics in Beijing .\
METHODS	All subjects received dietary counseling according to the guidelines of the American Heart Association Step I diet .\
METHODS	After a 4 week run-in , subjects were randomized to consume either the recommended daily serving of 42 g pistachios ( RSG ) , a higher daily serving of 70 g pistachio ( HSG ) or no pistachios ( DCG ) for 12 weeks .\
RESULTS	Subjects in all three groups were matched at baseline for BMI : DCG 28.03 4.3 ; RSG 28.12 3.22 ; and HSG 28.01 4.51 kg/m2 .\
RESULTS	There were no significant changes in body weight or BMI in any groups during the study nor any change from baseline at any time point in any group .\
RESULTS	During the entire study , there were no significant differences in waist-to-hip ratio among the groups or any change from baseline in any group ( DCG -0.00 0.03 , RSG -0.01 0.02 and HSG 0.01 0.04 ) .\
RESULTS	There were no significant differences detected among groups in triglycerides , fasting glucose and 2 hour postprandial glucose following a 75 gram glucose challenge .\
RESULTS	Exploratory analyses demonstrated that glucose values 2 h after a 75 gm glucose challenge were significantly lower at week 12 compared with baseline values in the HSG group ( -1.13 2.58 mmol/L , p = 0.02 ) , and a similar trend was noted in the RSG group ( -0.77 2.07 mmol/L , p = 0.06 ) , while no significant change was seen in the DCG group ( -0.15 2.27 mmol/L , p = 0.530 ) .\
RESULTS	At the end of study , serum triglyceride levels were significantly lower compared with baseline in the RSG group ( -0.38 0.79 mmol/L , p = 0.018 ) , but no significant changes were observed in the HSG or DCG groups .\
CONCLUSIONS	Despite concerns that pistachio nut consumption may promote weight gain , the daily ingestion of either 42 g or 70 g of pistachios for 12 weeks did not lead to weight gain or an increase in waist-to-hip ratio in Chinese subjects with metabolic syndrome .\
CONCLUSIONS	In addition , pistachio consumption may improve the risk factor associated with the metabolic syndrome .\
\
###20002361\
BACKGROUND	After using propofol for a decade , pain on injection had been considered routine by patients and medical personnel .\
BACKGROUND	When given propofol from a different manufacturer , patients did not complain .\
BACKGROUND	Two preparations of propofol were compared .\
METHODS	A comparative , double-blind , randomized study was conducted in 22 adult patients undergoing pain relief procedures ; they received sedation by an intravenous injection of 1.7 mg/kg of propofol and then were treated with paravertebral injections .\
METHODS	Pain on injection was assessed by verbal complaint , movement of the extremity , of the whole body and recollection of pain at induction , when discharged .\
METHODS	Propofol from Baxter Laboratories , mixed with either 5 ml of 2 % lidocaine or 5 ml of NaCl 0.9 % , was compared with propofol Laboratorios Gray , which was similarly mixed .\
METHODS	Injections were randomly administered four times , blindly , to each of 22 patients .\
METHODS	Statistical analysis was conducted using the analysis of variance method .\
RESULTS	A total of 352 propofol injections were given .\
RESULTS	Each of the four propofol solutions was administered 88 times ; of patients receiving Baxter propofol + saline , 74 ( 84 % ) had pain ; when mixed with 2 % lidocaine 45 ( 50.2 % ) complained .\
RESULTS	After propofol Gray with NaCl 0.9 % was given , two patients ( 2.2 % ) experienced pain .\
RESULTS	Propofol Gray with 2 % lidocaine produced no pain .\
RESULTS	None of the latter group remembered having pain , whereas , those given propofol Baxter 54 ( 61.3 % ) and 26 ( 29.5 % ) remembered experiencing pain at injection .\
RESULTS	Pain on injection was prevented and statistically reduced ( < 0.01 ) with the propofol from Laboratorios Gray .\
CONCLUSIONS	By changing the formulation ( size of molecules and their dispersion ) of propofol , pain on injection was avoided .\
\
###23438800\
OBJECTIVE	Shoulder arthroscopic surgeries evolve with intense postoperative pain .\
OBJECTIVE	Several analgesic techniques have been advocated .\
OBJECTIVE	The aim of this study was to compare suprascapular and axillary nerve blocks in shoulder arthroscopy using the interscalene approach to brachial plexus blockade .\
METHODS	According to the technique used , sixty-eight patients were allocated into two groups : interscalene group ( IG , n = 34 ) and selective group ( SG , n = 34 ) , with neurostimulation approach used for both techniques .\
METHODS	After appropriate motor response , IG received 30 mL of 0.33 % levobupivacaine in 50 % enantiomeric excess with adrenalin 1:200,000 .\
METHODS	After motor response of suprascapular and axillary nerves , SG received 15 mL of the same substance on each nerve .\
METHODS	General anesthesia was then administered .\
METHODS	Variables assessed were time to perform the blocks , analgesia , opioid consumption , motor block , cardiovascular stability , patient satisfaction and acceptability .\
RESULTS	Time for interscalene blockade was significantly shorter than for selective blockade .\
RESULTS	Analgesia was significantly higher in the immediate postoperative period in IG and in the late postoperative period in SG .\
RESULTS	Morphine consumption was significantly higher in the first hour in SG .\
RESULTS	Motor block was significantly lower in SG .\
RESULTS	There was no difference between groups regarding cardiocirculatory stability and patient satisfaction and acceptability .\
RESULTS	Failure occurred in IG ( 1 ) and SG ( 2 ) .\
CONCLUSIONS	Both techniques are safe , effective , and with the same degree of satisfaction and acceptability .\
CONCLUSIONS	The selective blockade of both nerves showed satisfactory analgesia , with the advantage of providing motor block restricted to the shoulder .\
\
###23884497\
BACKGROUND	The use of medical adhesives for topical wound closure is gaining in popularity over conventional wound closure materials such as sutures and staples .\
BACKGROUND	Adhesives provide advantages in both wound closure and patient management with good cosmetic outcome and surgeon and patient satisfaction reported .\
OBJECTIVE	To compare the use of two currently marketed medical adhesives ; LiquiBand Flow Control and High Viscosity Dermabond for the topical closure of surgical incisions .\
METHODS	In a prospective blinded manner , subjects were randomly assigned LiquiBand or DermabondTM for topical closure of a surgical incision .\
METHODS	Variables compared included ease of use , time taken to close wound , subject and surgeon satisfaction with device and wound closure , cosmetic outcome at 90 days , and complication rates .\
RESULTS	Use of both devices resulted in effective wound closure with similar high levels of cosmesis subject and surgeon satisfaction , with only minor complications reported .\
RESULTS	There was no statistically significant difference between the devices for all the parameters studied , with the exception that the Liquiband device was found to significantly reduce the amount of time required for closure .\
CONCLUSIONS	As the two devices appear substantially equivalent in terms of key surgeon and patient variables , product cost should be the primary determinant in selection of the tissue glue device .\
\
###19135657\
OBJECTIVE	To examine and compare the efficacy and safety of GnRH agonist ( GnRHa ) vs. aromatase inhibitor in premenopausal women with leiomyomas .\
METHODS	Multicenter , randomized , controlled clinical trial .\
METHODS	University hospitals .\
METHODS	A total of 70 subjects with a single uterine myoma measuring > or = 5 cm .\
METHODS	Subjects were randomized into two groups with use of a random table .\
METHODS	They were treated with aromatase inhibitor ( group A ) or GnRHa ( group B ) .\
METHODS	Group A received letrozole ( 2.5 mg/d ) for 12 weeks .\
METHODS	Group B received triptorelin ( 3.75 mg/mo ) for 12 weeks .\
METHODS	Measurement of myoma volume and E ( 2 ) , FSH , LH , and T levels .\
RESULTS	Total myoma volume decreased by 45.6 % in group A and 33.2 % in group B. Reductions in myoma volume in the two groups were statistically significant .\
RESULTS	There was no significant change in hormonal milieu in group A.\
RESULTS	The serum level of hormones significantly decreased in group B by the 12th week of treatment .\
CONCLUSIONS	Uterine myoma volume was successfully reduced by use of an aromatase inhibitor .\
CONCLUSIONS	Rapid onset of action and avoidance of initial gonadotropin flare with an aromatase inhibitor may be advantageous for short-term management of women with myomas of any size who are to be managed transiently and who wish to avoid surgical intervention , specifically women with unexplained infertility having uterine myoma .\
\
###12451430\
OBJECTIVE	To examine the effect of fluconazole , a potent inhibitor of CYP2C9 and CYP2C19 , on the pharmacokinetics of rosuvastatin in healthy volunteers .\
OBJECTIVE	Significantly increased plasma concentrations of fluvastatin have been observed following co-administration with fluconazole .\
METHODS	This was a randomised , double-blind , two-way crossover , placebo-controlled trial .\
METHODS	Healthy male volunteers ( n = 14 ) were given fluconazole 200 mg or matching placebo once daily for 11 days ; rosuvastatin 80 mg was co-administered on day 8 of dosing .\
METHODS	Plasma concentrations of rosuvastatin , N-desmethyl rosuvastatin , and active and total 3-hydroxy-3-methylglutaryl coenzyme A ( HMG-CoA ) reductase inhibitors were measured up to 96 h post-dose .\
RESULTS	Following co-administration with fluconazole , rosuvastatin geometric least-square mean area under the plasma concentration-time curve ( AUC ( 0-t ) ) and peak plasma concentration ( C ( max ) ) were increased by 14 % and 9 % , respectively , compared with placebo ( 90 % confidence intervals for the treatment ratios : 0.967 to 1.341 and 0.874 to 1.355 , respectively ) .\
RESULTS	Individual treatment ratios for AUC ( 0-t ) ranged from 0.59 to 2.23 , and for C ( max ) ranged from 0.52 to 2.28 .\
RESULTS	The limited data available for the N-desmethyl metabolite show that geometric mean C ( max ) was decreased by approximately 25 % compared with placebo .\
RESULTS	Rosuvastatin accounted for essentially all of the circulating active HMG-CoA reductase inhibitors and most ( > 90 % ) of the total inhibitors .\
RESULTS	Fluconazole did not affect the proportion of circulating active or total inhibitors accounted for by circulating rosuvastatin .\
CONCLUSIONS	Fluconazole produced only small increases in rosuvastatin AUC ( 0-t ) and C ( max ) , which were not considered to be of clinical relevance .\
CONCLUSIONS	The results support previous in-vitro findings that CYP2C9 and CYP2C19 metabolism is not an important clearance mechanism for rosuvastatin .\
\
###21641360\
BACKGROUND	Elevated C-reactive protein ( CRP ) is a common finding in patients with aortic stenosis ( AS ) and may be associated with rapid AS progression and worse outcome .\
BACKGROUND	The purpose of the study was to examine the role of high-sensitivity CRP and its interaction with rosuvastatin on the progression of AS .\
METHODS	We measured CRP at baseline , 1 year , and end of follow-up in 260 patients with a median follow-up of 3.5 years .\
METHODS	Analyses were performed based on baseline CRP tertiles and baseline CRP > 3 and 3 mg/L .\
RESULTS	After adjustment for baseline characteristics , higher CRP levels were associated with age , female gender , body mass index , and lower high-density lipoprotein cholesterol levels but not with AS severity .\
RESULTS	Treatment with rosuvastatin led to a persistent decrease in CRP at 1 year and end of follow-up .\
RESULTS	Progression of AS was detected in patients in all 3 CRP tertiles , and rosuvastatin treatment had no impact on progression in all 3 tertiles .\
RESULTS	Similar findings were observed using CRP > 3 mg/L as the cutpoint .\
RESULTS	Multiple linear regression showed that baseline AS velocity ( P < .001 ) , but not CRP , was the only predictor of progression of AS ; age ( P = .05 ) and baseline AS velocity ( P < .001 ) , but not CRP and rosuvastatin treatment , were predictors of outcome events .\
CONCLUSIONS	C-reactive protein does not predict severity , progression , and prognosis in patients with mild to moderate AS .\
CONCLUSIONS	Treatment with rosuvastatin reduces CRP levels but has no effect on the progression and clinical events of AS .\
\
###11590517\
OBJECTIVE	To evaluate the 24-week impact of saquinavir-enhancing antiretroviral therapy on viral replication in patients previously treated with nucleoside analogues with or without prior saquinavir hard-gel capsules ( HGC ) .\
METHODS	Patients were randomized in three groups to receive the following : Group 1-nelfinavir ( 750 mg tid ) , saquinavir soft-gel capsule ( SGC ) ( 800 mg tid ) , and stavudine ( 40 mg bid ) ; Group II-ritonavir ( 400 mg bid ) , saquinavir-SGC ( 400 mg bid ) , and stavudine ( 40 mg bid ) ; or Group III-delavirdine ( 400 mg tid ) , saquinavir-SGC ( 800 mg tid ) , and stavudine ( 40 mg bid ) .\
METHODS	Viral loads , CD4 count , and safety were assessed over a 24-week period with an additional 6-month follow-up .\
RESULTS	73 patients received randomized therapy ; 14 of whom were SQV nave , with a median baseline viral load of 3.6 log ( 10 ) and a CD4 count of 370 cells/mm ( 3 ) .\
RESULTS	By 6 months , the median decreases in plasma viral loads were 0.26 , 0.71 , and 0.29 log ( 10 ) copies/mL for groups I , II , and III , respectively .\
RESULTS	The median increases in CD4 counts , for groups I , II , and III , were 52 , 40 , and 69 cells/mm ( 3 ) at 6 months , respectively .\
RESULTS	Changes in viral load and CD4 counts at 6 months and 1 year were not significantly different between the treatment groups .\
RESULTS	More patients discontinued therapy in the ritonavir arm ( 35 % ) for drug intolerance or toxicity compared to either the nelfinavir or delavirdine arms ( 15 % and 5 % , respectively ) .\
RESULTS	In a multivariate analysis , baseline viral load , younger age , and baseline saquinavir resistance were significantly associated with detectable viral load at 24 weeks .\
CONCLUSIONS	The use of antiretroviral agents that pharmacokinetically boost saquinavir levels has a modest benefit in saquinavir-experienced patients .\
\
###12352386\
OBJECTIVE	We conducted integrated analyses of the efficacy and safety of tadalafil , a potent , selective phosphodiesterase 5 inhibitor , for the treatment of erectile dysfunction .\
METHODS	A total of 1,112 men with a mean age of 59 years ( range 22 to 82 ) and mild to severe erectile dysfunction of various etiologies were randomized to placebo or tadalafil , taken as needed without food or alcohol restrictions , at fixed daily doses of 2.5 mg , 5 mg , 10 mg , or 20 mg up to a maximum of once daily [ DOSAGE ERROR CORRECTED ] in 5 randomized , double-blind , placebo controlled trials lasting 12 weeks .\
METHODS	The 3 co-primary outcomes were changes from baseline in the erectile function domain of the International Index of Erectile Function and the proportion of `` yes '' responses to questions 2 and 3 of the Sexual Encounter Profile .\
METHODS	Additional efficacy instruments included a Global Assessment Question .\
RESULTS	Compared with placebo , tadalafil significantly enhanced all efficacy outcomes .\
RESULTS	Patients receiving 20 mg .\
RESULTS	tadalafil experienced a significant mean improvement of 7.9 in International Index of Erectile Function erectile function domain score from baseline ( p < 0.001 versus placebo ) , 75 % of intercourse attempts ( Sexual Encounter Profile question 3 , a secondary efficacy outcome ) were successfully completed ( p < 0.001 versus placebo ) and 81 % reported improved erections at end point compared with 35 % in the control group ( p < 0.001 ) .\
RESULTS	Tadalafil was consistently efficacious across disease severities and etiologies , as well as in patients of all ages .\
RESULTS	Tadalafil was well tolerated , and headache and dyspepsia were the most frequent adverse events .\
CONCLUSIONS	Tadalafil was effective and well tolerated in this patient population .\
\
###23824463\
OBJECTIVE	We investigate the effects of 12-week interval training of moderate - or high-intensity exercise on blood lipids and plasma levels of adiponectin .\
METHODS	Thirty-four obese adolescent females [ age = 15.90.3 years ; BMI and BMI-Z-score = 30.81.6 kg/m ( 2 ) and 30.3 , respectively ] , were randomized to high-intensity interval training ( HIIT , n = 11 ) , moderate-intensity interval training ( MIIT , n = 11 ) , or a control group ( CG , n = 12 ) .\
METHODS	Maximal oxygen uptake ( [ Formula : see text ] ) , maximal aerobic speed ( MAS ) , plasma lipids and adiponectin levels were measured in all subjects before and after training .\
RESULTS	Following the training program , in both training groups , body mass , BMI-Z-score , and percentage body fat ( % BF ) decreased , while [ Formula : see text ] and MAS increased .\
RESULTS	Low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , and adiponectin levels were positively altered ( -12.6 and -7.4 % ; 6.3 and 8.0 % ; 35.8 and 16.2 % ; high to moderate training program , respectively ) .\
RESULTS	Waist circumference , triglyceride and total cholesterol decreased only in HIIT group ( -3.5 ; -5.3 and -7.0 % , respectively , in all P < 0.05 ) .\
RESULTS	Significant decrease in the usual index of insulin resistance ( HOMA-IR ) occurred in HIIT and MIIT groups ( -29.25.3 and -18.48.6 % , respectively ; P < 0.01 ) .\
CONCLUSIONS	The results show that HIIT positively changes blood lipids and adiponectin variables in obese adolescent girls , resulting in improved insulin sensitivity , as attested by a lower HOMA-IR , and achieving better results compared to moderate-intensity exercise .\
\
###9298051\
OBJECTIVE	To compare the effects of topical 0.5 % ketorolac tromethamine ophthalmic solution ( Acular , Allergen Pharmaceuticals , Irvine , Calif ) with topical 0.03 % flurbiprofen sodium ophthalmic solution ( Ocufen , Allergen Pharmaceuticals ) on the inhibition of surgically induced miosis during phacoemulsification cataract surgery .\
METHODS	One hundred eighteen patients were prospectively randomized to receive 0.5 % topical ketorolac or 0.03 % topical flurbiprofen at 3 preoperative intervals .\
METHODS	The flurbiprofen-treated group served as the control group .\
METHODS	The surgeon was masked as to patient selection .\
METHODS	Horizontal pupillary diameter measurements were obtained at the start of surgery , just before phacoemulsification , before lens implantation , and after lens implantation .\
RESULTS	Mean horizontal pupillary diameter measurements for both medications were similar at the start of surgery .\
RESULTS	However , a consistent trend of larger pupillary diameter was seen in all subsequent surgical intervals in the ketorolac-treated group .\
RESULTS	Changes from baseline measurements also indicated a more significant inhibition of miosis at all subsequent intervals , and a more stable mydriasis throughout the procedure in the ketorolac-treated group .\
CONCLUSIONS	Topical ketorolac is an effective inhibitor of miosis during phacoemulsification cataract surgery , and provides a more stable mydriatic effect throughout the surgical procedure .\
\
###12842515\
BACKGROUND	There is a paucity of controlled trials comparing the merits of different heart valve prostheses .\
BACKGROUND	In this prospective randomized trial we compared Starr Edwards and St. Jude prostheses in the aortic and mitral positions .\
METHODS	Two hundred sixty-seven patients and 122 patients undergoing aortic and mitral valve replacement , respectively , were allocated by minimization to receive either St. Jude or Starr Edwards prostheses .\
METHODS	Patients ( 2 patients were lost to follow-up ) were followed up in a special clinic .\
METHODS	Event definition , recording , and reporting were in accordance with published guidelines .\
RESULTS	There were no demographic differences between patients receiving the two different valve models .\
RESULTS	With the exception of infective endocarditis , we found no differences in the rates of death or complication between patients receiving a Starr Edwards prosthesis or a St. Jude prosthesis in either position .\
RESULTS	Neither were there any differences between the two valve models in either position , in terms of symptomatic relief 5 years after surgery .\
CONCLUSIONS	We found no differences in rates of complication or of symptomatic improvement between the Starr Edwards and St. Jude valve prostheses in either aortic or mitral position .\
CONCLUSIONS	Left ventricular function had such a marked effect on long-term survival that it overwhelmed any differences that might exist between different prosthetic designs .\
CONCLUSIONS	This confirms that historical comparisons are of limited value in deciding the respective merits of heart valve prostheses .\
CONCLUSIONS	The most reliable method of assessing surgical procedures is through prospective controlled trials .\
\
###19378318\
OBJECTIVE	We investigated body image dissatisfaction and bingeing/purging characteristics of bulimia nervosa ( BN ) in the ongoing prospective follow-up of the Multimodal Treatment Study of Children with attention-deficit/hyperactivity disorder ( ADHD ) .\
METHODS	Participants were 337 boys and 95 girls with ADHD and 211 boys and 53 girls forming a local normative comparison group ( LNCG ) , reassessed in midadolescence ( mean age , 16.4 ) , 8 years after original recruitment .\
RESULTS	Youth with childhood ADHD showed more BN symptoms in midadolescence than did LNCG youth , and girls demonstrated more BN symptoms than did boys , with effect sizes between small and medium .\
RESULTS	Childhood impulsivity , as opposed to hyperactivity or inattention , best predicted adolescent BN symptoms , particularly for girls .\
RESULTS	Among youth with ADHD , treatment received during the follow-up period was not associated with BN pathology .\
CONCLUSIONS	Both boys and girls with ADHD may be at risk for BN symptoms in adolescence because of the impulsivity central to both disorders .\
\
###18658066\
OBJECTIVE	The primary purpose of this study was to investigate child impacts following implementation of a comprehensive language curriculum , the Language-Focused Curriculum ( LFC ; Bunce , 1995 ) , within their preschool classrooms .\
OBJECTIVE	As part of this larger purpose , this study identified child-level predictors of expressive language outcomes for children attending at-risk preschool programs as well as main effects for children 's exposure to the language curriculum and its active ingredients-namely , teacher use of language stimulation techniques ( LSTs ; e.g. , open questions , recasts , models ) .\
METHODS	Fourteen preschool teachers were randomly assigned to 2 conditions .\
METHODS	Treatment teachers implemented the experimental curriculum for an academic year ; a total of 100 children were enrolled in their classrooms .\
METHODS	Comparison teachers maintained their prevailing curriculum ; a total of 96 children were enrolled in these classrooms .\
METHODS	Teachers ' fidelity of implementation was monitored using structured observations conducted 3 times during the academic year .\
METHODS	Children 's growth in expressive language was assessed using measures derived from language samples in the fall and spring , specifically percent complex utterances , rate of noun use , number of different words , and upper bound index .\
RESULTS	Children 's language skill in the fall , socioeconomic status ( household income ) , and daily attendance served as significant , positive predictors of their language skill in the spring .\
RESULTS	The impact of the language curriculum and LST exposure was moderated by children 's classroom attendance , in that the language curriculum accelerated language growth for children who attended preschool regularly ; a similar effect was seen for LST exposure .\
CONCLUSIONS	Adoption of a comprehensive language curriculum may provide a value-added benefit only under highly specific circumstances .\
CONCLUSIONS	Findings suggest that at-risk children who receive relatively large doses of a curriculum ( as measured in days of attendance during the academic year ) that emphasizes quality language instruction may experience accelerated expressive language growth during pre-kindergarten .\
\
###22157392\
OBJECTIVE	The purpose of this pilot study was to evaluate the safety and efficacy of azithromycin ophthalmic solution 1 % in patients with contact lens-related dry eye ( CLDE ) .\
METHODS	This was a 4-week , single-center , open-label clinical trial in patients diagnosed with CLDE using the Contact Lens Dry Eye Questionnaire ( CLDEQ ) .\
METHODS	Fifty patients were enrolled in this study .\
METHODS	The patients were randomized to 1 of 2 treatment groups : azithromycin ophthalmic solution administered bid on days 1 and 2 and on days 3 to 291 or Visine for Contacts rewetting drops administered qid on days 1 to 291 .\
METHODS	The patient diaries were used daily to collect data on comfortable and total contact lens wear time and ocular dryness throughout the treatment period .\
METHODS	Tear osmolarity , fluorescein corneal staining , and visual acuity were also assessed during clinic visits .\
RESULTS	Fifty patients were enrolled , and 44 completed the study .\
RESULTS	One patient discontinued in the azithromycin group , and five patients discontinued in the rewetting drops group because of adverse events .\
RESULTS	A statistically significant increase in mean comfortable contact lens wear time from baseline was observed for the subjects treated with azithromycin ophthalmic solution as compared with the subjects treated with rewetting drops at week 4 ( P = 0.004 ; primary endpoint ) , in addition to weeks 2 and 3 .\
RESULTS	The improvement in the mean comfortable wear time for the patients in the azithromycin treatment group exceeded 2 hrs throughout the treatment period ( weeks 1-4 ) .\
RESULTS	No significant differences were observed between the groups for total wear time , low contrast visual acuity , or tear osmolarity .\
RESULTS	Subject-rated ocular dryness ( PM time assessments ) was significantly improved from baseline in the subjects treated with azithromycin ophthalmic solution as compared with those treated with rewetting drops at weeks 2 and 3 endpoints ( P = 0.015 for each week ) .\
RESULTS	Additionally , a statistical difference was observed in favor of the azithromycin treatment group at week 2 for the subjects reclassifying as nondry eye as determined by the CLDEQ ( P = 0.05 ) .\
CONCLUSIONS	Treatment with topical azithromycin ophthalmic solution was well tolerated and resulted in a significant improvement in comfortable contact lens wear time in the patients with CLDE .\
\
###15913411\
BACKGROUND	Night float rotations are used in residency training programs to reduce residents ' sleep deprivation .\
BACKGROUND	Night shift work , however , is accompanied by deleterious effects on sleep , mood , and attention .\
OBJECTIVE	To test whether melatonin reduces the deleterious effects of night shift work on sleep , mood , and attention in pediatric residents during night float rotation .\
METHODS	Double-blind , randomized , placebo-controlled crossover .\
METHODS	Participants took melatonin ( 3 mg ) or a placebo before bedtime in the morning after night shift ; completed a sleep diary and an adverse-effects questionnaire daily ; and completed the Profile of Mood States and the Conners Continuous Performance Test 3 times in each study week to test mood and attention , respectively .\
METHODS	A university-affiliated , tertiary-care pediatric hospital .\
METHODS	Healthy second-year pediatric residents working 2 night float rotations .\
METHODS	Standardized measures of sleep , mood , and attention .\
RESULTS	Twenty-eight residents completed both treatments ; 17 completed 1 treatment ( 10 placebo , 7 melatonin ) .\
RESULTS	There was not a statistically significant difference in measures of sleep , mood , and 5 of 6 measures of attention during melatonin and placebo treatment .\
RESULTS	One measure of attention , the number of omission errors , was significantly lower on melatonin ( 3.0 + / - 9.6 ) than on placebo ( 4.5 + / - 17.5 ) ( z = -2.12 , P = .03 ) .\
CONCLUSIONS	The isolated finding of improvement of 1 single measure of attention in a test situation during melatonin treatment was not sufficiently robust to demonstrate a beneficial effect of melatonin in the dose used .\
CONCLUSIONS	Other strategies need to be considered to help residents in adaptation to night shift work .\
\
###9924155\
BACKGROUND	Certain characteristics of unstable angina have been associated with worse clinical outcomes after percutaneous revascularization procedures .\
RESULTS	We compared outcomes of patients with ( n = 690 ) and those without ( n = 320 ) unstable angina in the Coronary Angioplasty Versus Excisional Atherectomy Trial ( CAVEAT-I ) by unstable angina subgroup : rest chest pain , postinfarction chest pain , chest pain with ischemic electrocardiographic changes , chest pain with recent acceleration , and no chest pain .\
RESULTS	Regression models were constructed to predict in-hospital and 6-month composite end point death , infarction , bypass surgery , percutaneous revascularization , and abrupt closure ( in-hospital ) or restenosis ( 6 months ) for each subgroup .\
RESULTS	Only chest pain with electrocardiographic changes predicted the composite in-hospital outcome ( 24 % vs 17 % with no chest pain , P = .0374 . )\
RESULTS	This subgroup also had a greater acute gain , more late loss , and more restenosis than patients in the other subgroups .\
RESULTS	Rest chest pain carried a higher incidence of the composite 6-month outcome ( 39.9 % vs 29 % with no chest pain , P = .0472 ) .\
RESULTS	For all unstable angina categories , atherectomy was associated with worse overall outcomes than angioplasty .\
CONCLUSIONS	Patients with unstable angina have more complications of percutaneous revascularization than patients without unstable angina , but event rates vary by anginal subgroup .\
CONCLUSIONS	The clinical presentation may help to identify unstable angina patients at particularly high risk for adverse outcomes .\
\
###19880429\
OBJECTIVE	We previously reported that the nonpeptide tachykinin NK ( 2 ) receptor antagonist SR48968 ( saredutant ) significantly inhibits neurokinin A-induced bronchoconstriction in patients with asthma .\
OBJECTIVE	MEN11420 ( nepadutant ) is a bicyclic peptide tachykinin NK ( 2 ) receptor antagonist .\
OBJECTIVE	The aim of the trial was to examine the effect of nepadutant on neurokinin A-induced bronchoconstriction in man .\
METHODS	12 patients with stable , mild to moderate asthma participated in a double-blind , placebo-controlled crossover trial and received , with intervals of 1 week , MEN11420 2 mg , MEN11420 8 mg and placebo ( i.v. ) .\
METHODS	Increasing concentrations of NKA ( 10 ( -9 ) to 10 ( -6 ) moles/ml ) were inhaled immediately after ( d1 ) and 24 hours after ( d2 ) administration of treatment .\
RESULTS	On d1 both MEN11420 2 and 8 mg shifted the dose response curve for neurokinin A to the right ( log PC ( 20 ) FEV ( 1 ) neurokinin A [ moles/ml ] ; mean + or = or - SEM -6.38 + or - 0.26 after 2 mg , -6.11 + or - 0.23 after 8 mg , versus -6.95 + or - 0.27 after placebo ] .\
RESULTS	On d2 MEN11420 had no effect on neurokinin A-induced bronchoconstriction .\
CONCLUSIONS	In conclusion , the tachykinin NK ( 2 ) receptor antagonist nepadutant significantly inhibits bronchoconstriction induced by neurokinin A in patients with asthma .\
\
###10148407\
OBJECTIVE	To compare the incidence of pulmonary complications and hospital resource utilisation in patients treated with continuous rotation therapy versus manual turning in a traditional hospital bed .\
METHODS	Prospective , randomised clinical trial .\
METHODS	Surgical intensive care unit of a large , tertiary care , urban hospital .\
METHODS	One-hundred-and-thirty-seven consecutive injured patients admitted to the Surgical Intensive Care Unit were prospectively randomised to receive either the Rotorest Kinetic Treatment Table or a traditional hospital bed .\
METHODS	One hundred of these patients met the study criteria and are the basis of this report .\
METHODS	The patients ' medical records were reviewed in a prospective manner to determine the frequency and severity of pulmonary complications and resource utilisation in the two patient groups .\
RESULTS	There were no significant differences in the minimum , average , or maximum pO 2 , pCO 2 , PEEP , IMV rate , or pre-extubation blood gases during the first seven days of the study .\
RESULTS	Fewer cardiac output measurements , arterial blood gas measurements , chest X-rays , respiratory therapies , hours intubated , days in the ICU , days in the step-down unit , days in the hospital , and lower ICU charges , respiratory care charges , and total hospital charges were utilised in the patients treated with the kinetic bed .\
RESULTS	The incidence of pulmonary event complications and process complications was lower in the group of patients treated on the Rotorest bed .\
RESULTS	( ABSTRACT TRUNCATED AT 250 WORDS )\
\
###24630742\
OBJECTIVE	Negative symptoms are known to undermine functional outcomes in people with schizophrenia ; however , most studies have not accounted for whether these symptoms were primary or secondary to other psychopathological factors .\
OBJECTIVE	The present study examined the impact of primary negative symptoms on functional outcomes in patients with schizophrenia .\
METHODS	The sample included 1427 patients with schizophrenia who completed the baseline visit in the CATIE study .\
METHODS	Symptoms were assessed with the Positive and Negative Syndrome Scale and Calgary Depression Scale , extrapyramidal side effects with the Simpson-Angus scale , and functional status with the Heinrichs-Carpenter Quality of Life Scale .\
RESULTS	Negative symptoms were significantly and inversely related to each domain of functioning examined .\
RESULTS	These relationships remained after statistically controlling for the influence of potential sources of secondary negative symptoms .\
RESULTS	In addition , the relationships between negative symptoms and specific domains of functioning remained in patients who had mild/absent positive , depressive , anxiety and extrapyramidal symptoms .\
RESULTS	Negative symptoms were associated with functional outcomes even in antipsychotic-free patients .\
CONCLUSIONS	Primary negative symptoms significantly contribute to the functional impairment seen in people with schizophrenia .\
CONCLUSIONS	A better understanding of the etiology and pathobiology of these symptoms is required to guide the search for effective therapeutics that promote functional recovery .\
\
###20044530\
OBJECTIVE	Patients with cerebral amyloid angiopathy ( CAA ) are at high risk for intracerebral hemorrhage ( ICH ) , but no effective prevention strategies have been established .\
OBJECTIVE	The objective is to determine whether lowering of blood pressure ( BP ) provides protection for this high-risk patient group .\
METHODS	This study is a subsidiary analysis of the PROGRESS trial-a randomized , placebo-controlled trial that established the beneficial effects of BP lowering in patients with cerebrovascular disease ; 6105 patients were randomly assigned to either active treatment ( perindopril for all participants plus indapamide for those with neither an indication for nor a contraindication to a diuretic ) or matching placebo .\
METHODS	Outcomes were probable CAA-related ICH as defined by the Boston criteria , probable hypertension-related ICH , and unclassified ICH .\
RESULTS	Over a mean follow-up of 3.9 years , 16 probable CAA-related ICH , 51 probable hypertension-related ICH , and 44 unclassified ICH occurred .\
RESULTS	Active treatment reduced the risk of CAA-related ICH by 77 % ( 95 % CI , 19 % -93 % ) , that of hypertension-related ICH by 46 % ( 95 % CI , 4 % -69 % ) , and that of unclassified ICH by 43 % ( 95 % CI , -5 % -69 % ) .\
RESULTS	There was no evidence of differences in the magnitude of the effects of treatment among different types of ICH ( P homogeneity = 0.4 ) .\
CONCLUSIONS	BP-lowering treatment is likely to provide protection against all types of ICH .\
\
###15841998\
OBJECTIVE	This prospective randomized trial was designed to compare intranasal endoscopic sphenopalatine artery ligation ( ESAL ) with conventional nasal packing in the treatment of recurrent epistaxis .\
METHODS	Patients were registered in the study databank following referral for epistaxis control to the otolaryngology service at the University of Alberta .\
METHODS	All patients were initially packed using Merocel ( Xomed Surgical Products , Jacksonville , FL ) nasal dressings bilaterally .\
METHODS	Patients were enrolled in the study following failure of Merocel packings .\
METHODS	Informed consent was obtained in accordance with the Health Research Ethics Board .\
METHODS	The patients were then managed with Vaseline nasal packs or ESAL .\
METHODS	Patient demographics , treatment characteristics , number of hospitalization days , and rates of recurrence were recorded prospectively .\
METHODS	The total cost of treatment for each patient was calculated .\
RESULTS	Nineteen patients were enrolled in the study .\
RESULTS	There was a significant reduction in cost and length of hospitalization of the patients undergoing ESAL compared with the conventional nasal packings .\
RESULTS	ESAL was also 89 % effective in controlling the bleeding and had minimal sequelae or complications .\
RESULTS	The overall calculated cost of patients undergoing ESAL was dollars 5133 compared with dollars 12213 in the conservative group , resulting in an average saving of dollars 7080 per patient .\
RESULTS	There was overwhelming patient satisfaction with ESAL compared with nasal packings .\
CONCLUSIONS	ESAL is an excellent , well-tolerated , and cost-effective method of treating recurrent epistaxis .\
\
###23532747\
OBJECTIVE	Anxiety in major depression is associated with increased morbidity .\
OBJECTIVE	The antidepressant , agomelatine , which acts as an agonist at melatonin MT ( 1 ) and MT ( 2 ) receptors and as an antagonist at serotonin 5-HT ( 2C ) receptors , has demonstrated efficacy and safety in both major depression and generalized anxiety disorder .\
OBJECTIVE	Here , we investigated the efficacy of agomelatine in anxious depression .\
METHODS	Data from three placebo-controlled short-term trials of agomelatine and three comparative studies of agomelatine versus fluoxetine , sertraline , and venlafaxine were pooled .\
METHODS	Effects of agomelatine on anxiety symptoms were assessed with the Hamilton Anxiety Rating Scale in four studies ( one vs placebo and three vs active comparator ) and with the Hamilton Depression Rating Scale ( HAMD ) anxiety subscore in all six studies .\
METHODS	Anxiolytic and antidepressant efficacies of agomelatine were assessed in patients with more severe anxiety symptoms at baseline ( score 5 on HAMD anxiety subscore ) .\
RESULTS	Agomelatine had a significantly greater effect on anxiety symptoms than both placebo and a number of comparator antidepressants .\
RESULTS	In more anxious depressed patients , agomelatine had a significantly greater effect on anxiety and depressive symptoms than both placebo and comparator antidepressants .\
CONCLUSIONS	Once-a-day oral agomelatine is a new , efficacious alternative option for the treatment of anxiety in patients with major depression .\
\
###18783606\
BACKGROUND	Infestation with the human head louse ( Pediculus humanus capitis ) occurs worldwide .\
BACKGROUND	Existing treatment options are limited , and reports of resistance to commonly used pediculicides have been increasing .\
BACKGROUND	In this trial we assessed the efficacy of a product containing a high ( 92 % ) concentration of the silicone oil dimeticone ( identical in composition to NYDA ( R ) ) , as compared to a 1 % permethrin lotion .\
METHODS	Randomized , controlled , observer blinded clinical trial .\
METHODS	Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent .\
METHODS	To minimize reinfestation during the trial , participants ( 145 children aged 5-15 years with head lice infestations ) were transferred to a holiday resort outside the endemic area for a period of 9 days .\
METHODS	Two applications of dimeticone or 1 % permethrin were done , seven days apart .\
METHODS	Outcome measures were defined as cure ( absence of vital head lice ) after first application and before and after second applications , degree of itching , cosmetic acceptability , and clinical pathology .\
RESULTS	Overall cure rates were : day 2 - dimeticone 94.5 % ( 95 % CI : 86.6 % - 98.5 % ) and permethrin 66.7 % ( 95 % CI : 54.6 % - 77.3 % ; p < 0.0001 ) ; day 7 - dimeticone 64.4 % ( 95 % CI : 53.3 % - 75.3 % ) and permethrin 59.7 % ( 95 % CI : 47.5 % - 71.1 % ; p = 0.5 ) ; day 9 - dimeticone 97.2 % ( 95 % CI : 90.3 % - 99.7 % ) and permethrin 67.6 % ( 95 % CI : 55.4 % -78.2 % ) ; p < 0.0001 ) .\
RESULTS	Itching was reduced similarly in both groups .\
RESULTS	Cosmetic acceptability was significantly better in the dimeticone group as compared to the permethrin group ( p = 0.01 ) .\
RESULTS	Two mild product-related incidents occurred in the dimeticone group .\
CONCLUSIONS	The dimeticone product is a safe and highly efficacious pediculicide .\
CONCLUSIONS	Due to its physical mode of action ( interruption of the lice 's oxygen supply of the central nervous system ) , development of resistance is unlikely .\
BACKGROUND	Current Controlled Trials ISRCTN15117709 .\
\
###20348185\
BACKGROUND	Short-term adherence to physical activity ( PA ) in older adults improves psychomotor processing abilities and is associated with greater brain activation .\
BACKGROUND	It is not known whether these associations are also significant for longer-term adherence to moderate-intensity activities .\
METHODS	We measured the cross-sectional association of regular walking with brain activation while performing the digit symbol substitution test ( DSST ) .\
METHODS	Participants of the lifestyle interventions and independence for elders-pilot study were examined 2 years after completing a 1-year treatment , consisting of either PA or education in successful aging ( SA ) .\
METHODS	Data were obtained from 20 PA participants who reported having remained active for 2 years after the end of the treatment and from 10 SA participants who reported having remained sedentary during the same period ( mean age : 81.5 and 80.8 years ) .\
METHODS	Complete brain activation and behavioral data were available for 17 PA and 10 SA participants .\
RESULTS	Two years after the formal intervention had ended , the PA group engaged in more minutes of moderate activity and had significantly greater DSST score and higher brain activation within regions important for processing speed ( left dorsolateral prefrontal , posterior parietal , and anterior cingulate cortices ) .\
RESULTS	Associations were independent of self-reported health , blood pressure , cognition , medication records , gray matter atrophy , and white matter hyperintensities .\
CONCLUSIONS	Persistent engagement in PA may have beneficial effects on psychomotor processing speed and brain activation , even for moderate levels and even when started late in life .\
CONCLUSIONS	Future studies are warranted to assess whether these beneficial effects are explained by delayed neuronal degeneration and/or new neurogenesis .\
\
###22239608\
BACKGROUND	Although there are several studies about the alteration in skin flora , limited number of reports about changes in the microbial contents and their resistance profile of other body sites in patients treated with isotretinoin for acne vulgaris .\
OBJECTIVE	The aim of this study was to investigate the effects of systemic isotretinoin and antibiotic therapy on the microbial floras of oropharynx , nose and feces in acne patients .\
METHODS	Treatment groups of isotretinoin and antibiotics consisting of 20 and 15 patients , respectively were included .\
METHODS	Microbiological culture samples were taken at baseline and once a month during 4-6 months of treatment period .\
RESULTS	Difference in microbial flora throughout the treatment period was detected at least among one of all culture samples of 15 ( 75 % ) and 5 ( 33 % ) patients in isotretinoin and antibiotic groups .\
RESULTS	There was statistically significant difference between two groups in means of alteration of the microbial flora ( P = 0.013 ) .\
RESULTS	The difference was definitely observed among nasal cultures ( 65 % ) in isotretinoin group and fecal cultures ( 20 % ) in the other .\
RESULTS	Staphylococcus aureus colonization was prominent in the microbial floras of nose and oropharynx and 2 of 14 nasal isolates were detected to be methicilline resistant while Escherichia coli with extended spectrum beta lactamase activity was detected in fecal floras of patients in isotretinoin group .\
CONCLUSIONS	Systemic isotretinoin and antibiotic treatments in acne patients precisely caused variations in the microbial floras of several sites of the body , while isotretinoin was commonly more responsible than antibiotics .\
CONCLUSIONS	Knowing that alterations in the microbial colonization of the flora regions may preceede infectious disease and bacterial resistance , treatment options and follow-up procedures in acne vulgaris should be carefully determined to reduce the risk of destruction of the microbial flora .\
\
###24119081\
BACKGROUND	Utilization of total knee arthroplasty is increasing rapidly .\
BACKGROUND	A substantial number of total knee arthroplasty recipients have persistent pain after surgery .\
BACKGROUND	Our objective was to design a randomized controlled trial to establish the efficacy of a motivational-interviewing-based telephone intervention aimed at improving patient outcomes and satisfaction following total knee arthroplasty .\
METHODS	The study was conducted at Brigham and Women 's Hospital in Boston , Massachusetts .\
METHODS	The study focused on individuals 40 years or older with a primary diagnosis of osteoarthritis who were scheduled for total knee arthroplasty .\
METHODS	The study compared two management strategies over the first six months postoperatively : 1 ) enhanced postoperative care with frequent follow-up by a care navigator ; 2 ) usual postoperative care .\
METHODS	Those who were randomized into the enhanced postoperative care arm received ten calls from a trained non-clinician care navigator over the first six postoperative months .\
METHODS	The navigator used motivational interviewing techniques to engage patients in discussions related to their rehabilitation goals , including patient 's plans for and confidence in achieving those goals .\
METHODS	Patients in the usual care arm received standard postoperative management and received no navigator phone calls .\
METHODS	Patients in both arms were assessed at baseline , three months , and six months postoperatively .\
CONCLUSIONS	The primary outcome of the study was improvement in function as measured by the difference in Western Ontario and McMaster Universities Osteoarthritis Index function score between preoperative ( baseline ) status and six months postoperatively .\
CONCLUSIONS	Data were collected to identify factors that may be related to total knee arthroplasty outcomes , including preoperative pain , pain catastrophizing , self-efficacy , and depression .\
CONCLUSIONS	A formal economic analysis is also planned to determine the cost-effectiveness of the care navigator as a component of total knee arthroplasty care .\
BACKGROUND	ClinicalTrials.gov NCT01540851 .\
\
###21854643\
BACKGROUND	Fall incidents represent an increasing public health problem in aging societies worldwide .\
BACKGROUND	A major risk factor for falls is the use of fall-risk increasing drugs .\
BACKGROUND	The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus ` care as usual ' in older adults presenting at the Emergency Department after a fall .\
METHODS	A prospective , multi-center , randomized controlled trial will be conducted in hospitals in the Netherlands .\
METHODS	Persons aged 65 years who visit the Emergency Department due to a fall are invited to participate in this trial .\
METHODS	All patients receive a full geriatric assessment at the research outpatient clinic .\
METHODS	Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and ` care as usual ' .\
METHODS	A 3-monthly falls calendar is used for assessing the number of falls , fallers and associated injuries over a one-year follow-up period .\
METHODS	Measurements will be at three , six , nine , and twelve months and include functional outcome , healthcare consumption , socio-demographic characteristics , and clinical information .\
METHODS	After twelve months a second visit to the research outpatient clinic will be performed , and adherence to the new medication regimen in the intervention group will be measured .\
METHODS	The primary outcome will be the incidence of new falls .\
METHODS	Secondary outcome measurements are possible health effects of medication withdrawal , health-related quality of life ( Short Form-12 and EuroQol-5D ) , costs , and cost-effectiveness of the intervention .\
METHODS	Data will be analyzed using an intention-to-treat analysis .\
CONCLUSIONS	The successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction .\
BACKGROUND	The trial is registered in the Netherlands Trial Register ( NTR1593 ) .\
\
###18722198\
OBJECTIVE	The purpose of this pilot novel chiropractic health education intervention was to gather preliminary evidence regarding possible benefits from recreational youth soccer and nutrition education in overweight women .\
OBJECTIVE	A secondary purpose was to determine whether some nutrition knowledge is an independent predictor of changes in body mass index ( BMI ) .\
METHODS	A quiz developed and validated on separate age and sex appropriate blinded cohorts was used on study participants-22 volunteers of 57 eligible fourth-grade , overweight female Mississippi public school students .\
METHODS	At the beginning of a 5-month study period , a 15-minute baseline nutrition intervention , grounded in Social Cognitive Theory and based on the United States Department of Agriculture 's `` My Tips for Families '' information , was applied in a chiropractic clinic .\
METHODS	Subjects were then randomized to 2 months of recreational soccer ( n = 14 ) or waiting list control ( n = 8 ) .\
RESULTS	No preintervention differences were found in height , weight , BMI , or age .\
RESULTS	Higher follow-up BMI scores were found in both groups , and no significant differences between groups were found , possibly because of the small sample sizes and the short 8-week soccer intervention period .\
RESULTS	Gains in nutrition knowledge were sustained ( P < .002 ) ; however , there was no association between nutrition knowledge and follow-up BMI ( r = -.185 ; P < .462 ) .\
CONCLUSIONS	Minimal nutrition education alone may be an ineffective intervention for overweight children .\
CONCLUSIONS	The study provides an example of how youth soccer may benefit overweight children .\
\
###10200006\
BACKGROUND	The effect of H1-blockers may differ depending on the target organ .\
OBJECTIVE	A double-blind , placebo-controlled study was carried out to compare the effect of a 7-day treatment with loratadine ( 10 mg daily ) or cetirizine ( 10 mg daily ) on nasal challenge with grass pollen grains and skin tests with allergen or histamine .\
METHODS	Twenty-four patients were enrolled , but the analysis was carried out on 23 .\
METHODS	Nasal challenge was carried out by using 5-fold increasing numbers of pollen grains .\
METHODS	Skin prick tests were done with serial concentrations of allergens and 1 concentration of histamine .\
METHODS	Patients were tested in a cross-over design , with each treatment being administered for the previous 7 days and with a 2-week washout period .\
RESULTS	By comparison with placebo , loratadine and cetirizine increased significantly the threshold number of pollen grains required to induce a positive nasal challenge ( P < .001 ) .\
RESULTS	There was no difference between loratadine and cetirizine .\
RESULTS	Skin test responses to allergen were significantly reduced by loratadine and cetirizine by comparison with placebo .\
RESULTS	Skin test responses to histamine were significantly decreased by the 2 H1-blockers , but they were more profoundly decreased by cetirizine than by loratadine .\
CONCLUSIONS	Both H1-blockers reduced similarly allergen-induced skin test and nasal challenge responses .\
CONCLUSIONS	Cetirizine was more effective on histamine skin test responses .\
\
###23517883\
BACKGROUND	There is limited research on the applicability and effectiveness of Acceptance and Commitment Therapy ( ACT ) for people experiencing psychotic disorders .\
BACKGROUND	Clinical trials suggest ACT may be efficacious in reducing distress and rehospitalization rates in psychosis .\
BACKGROUND	Mindfulness and reduced literal believability of thought content have been associated with reduced distress for this population .\
OBJECTIVE	To better understand ACT for psychosis , this study investigated clients ' perspectives of the hypothesized active therapeutic processes of ACT .\
METHODS	Semistructured interviews , conducted with nine adults diagnosed with schizophrenia or schizoaffective disorder and persistent positive symptoms , were analysed thematically .\
RESULTS	Four themes emerged : Usefulness of therapy ; Changes attributed to ACT ; Understanding of therapy ; and Non-specific therapy factors .\
RESULTS	All participants found therapy useful and recommended ACT .\
RESULTS	Mindfulness , defusion , acceptance and values work were described as the most useful therapy components and contributing to positive changes .\
RESULTS	Self-rated frequency of symptoms did not change ; however a reduction in the intensity and distress associated with symptoms was reported .\
RESULTS	Non-specific therapy factors were deemed useful by participants but not directly related to outcome .\
CONCLUSIONS	These findings are consistent with the theoretically defined underlying active processes of ACT and are relevant for this population .\
CONCLUSIONS	The findings also indicate important clinical implications for ACT for this client group : greater attention to the client connecting metaphors and concepts to the intended meaning may be valuable ; caution should be used with some mindfulness and defusion techniques for intense experiences ; and values work may be particularly useful for this population .\
\
###17685172\
OBJECTIVE	Children with fine-motor problems and handwriting difficulties often are referred for occupational therapy .\
OBJECTIVE	The objective of this study was to test the efficacy of a short-term treatment on the fine-motor and graphomotor skills of first-grade students .\
METHODS	We recruited 52 first-grade students who had scored below the 21st percentile on the Visual-Motor Integration test from schools in a city with a low socioeconomic , mixed ( Arab and Jewish ) population .\
METHODS	The children were randomly divided into an intervention group and a control group .\
METHODS	Before and after the intervention , we administered two tests to both groups .\
RESULTS	Students in the intervention group made significant gains both in the total score on the graphomotor test ( Developmental Test of Visual Perception ) and on the fine-motor test ( Bruininks-Oseretsky Motor Development Scale ) .\
CONCLUSIONS	This study provided preliminary evidence of the efficacy of a short-term graphomotor intervention .\
CONCLUSIONS	The results increased the feasibility of implementing occupational therapy intervention in the Israeli school system , allowing treatment of more children using the same resources .\
\
###10716458\
OBJECTIVE	This study sought to determine the safety , feasibility and outcome of local delivery of cytochalasin B at the site of coronary angioplasty .\
BACKGROUND	Previous failures in the pharmacologic prevention of restenosis may have been related to inadequate dosing at the angioplasty site as a result of systemic drug administration .\
BACKGROUND	Alternatively , although previous experimental protocols have typically targeted control of excess tissue growth ( intimal hyperplasia ) , it now appears that overall arterial constriction ( vascular remodeling ) is the major contributor to late lumen loss .\
BACKGROUND	Cytochalasin B inhibits the polymerization of actin and has proved to be a potent inhibitor of vascular remodeling in animal models .\
METHODS	In this phase I , multicenter , randomized , controlled trial , cytochalasin B ( or matching placebo ) was administered to the site of a successful balloon angioplasty using a microporous local delivery infusion balloon .\
RESULTS	The rate of drug delivery at a constant infusion pressure varied significantly from patient to patient ( range 1.7 to 20.2 ml/min ) , perhaps related to a variable constricting effect of the atherosclerotic plaque on the infusion balloon .\
RESULTS	The minimal stenosis diameter after the procedure was slightly better in the active drug group ( 1.86 + / - 0.44 vs. 1.49 + / - 0.63 mm , p < 0.03 ) , but this difference was not seen at four to six weeks .\
RESULTS	Although the study was not powered for clinical outcomes ( n = 43 ) , the combined end point ( death , nonfatal infarction or repeat revascularization ) was encountered in 20 % of the patients receiving cytochalasin B and in 38 % of the patients receiving placebo .\
RESULTS	Clinical restenosis occurred in 18 % of the treatment group and 22 % of the placebo group .\
RESULTS	There were no significant differences between groups in biochemical or electrocardiographic variables .\
CONCLUSIONS	Cytochalasin B can be safely administered by local delivery after successful coronary angioplasty and warrants further study of its efficacy in reducing restenosis .\
\
###25273991\
BACKGROUND	The United States has the highest rate of lumbar spine surgery in the world , with rates increasing over 200 % since 1990 .\
BACKGROUND	Medicare spends over $ 1 billion annually on lumbar spine surgery .\
BACKGROUND	Despite surgical advances , up to 40 % of patients report chronic pain and disability following surgery .\
BACKGROUND	Our work has demonstrated that fear of movement is a risk factor for increased pain and disability and decreased physical function in patients following lumbar spine surgery for degenerative conditions .\
BACKGROUND	Cognitive-behavioral therapy and self-management treatments have the potential to address psychosocial risk factors and improve outcomes after spine surgery , but are unavailable or insufficiently adapted for postoperative care .\
BACKGROUND	Our research team developed a cognitive-behavioral based self-management approach to postoperative rehabilitation ( Changing Behavior through Physical Therapy ( CBPT ) ) .\
BACKGROUND	Pilot testing of the CBPT program demonstrated greater improvement in pain , disability , physical and mental health , and physical performance compared to education .\
BACKGROUND	The current study compares which of two treatments provided by telephone - a CBPT Program or an Education Program about postoperative recovery - are more effective for improving patient-centered outcomes in adults following lumbar spine surgery for degenerative conditions .\
METHODS	A multi-center , comparative effectiveness trial will be conducted .\
METHODS	Two hundred and sixty patients undergoing lumbar spine surgery for degenerative conditions will be recruited from two medical centers and community surgical practices .\
METHODS	Participants will be randomly assigned to CBPT or Education at 6weeks following surgery .\
METHODS	Treatments consist of six weekly telephone sessions with a trained physical therapist .\
METHODS	The primary outcome will be disability and secondary outcomes include pain , general health , and physical activity .\
METHODS	Outcomes will be assessed preoperatively and at 6weeks , 6months and 12months after surgery by an assessor masked to group allocation .\
CONCLUSIONS	Effective rehabilitation treatments that can guide clinicians in their recommendations , and patients in their actions will have the potential to effect change in current clinical practice .\
BACKGROUND	NCT02184143 .\
\
###25644495\
OBJECTIVE	Septal body hypertrophy , like inferior turbinate hypertrophy , can result in changes to the nasal cross-sectional area and resistance to airflow .\
OBJECTIVE	The aim of this study is to evaluate the efficacy of septal body volume reduction ( SBVR ) for the treatment of septal body hypertrophy in patients with nasal obstruction .\
METHODS	Prospective randomized study .\
METHODS	The study was conducted on two groups ( 51 patients ) with symptoms and signs of nasal obstruction associated with septal body and inferior turbinate hypertrophy that were refractory to medical therapy .\
METHODS	In the turbinoplasty only ( ITR ) group ( n = 25 ) , conventional turbinoplasty was only performed on the inferior turbinate .\
METHODS	In the septal body reduction ( SBR ) group ( n = 26 ) , concurrent bilateral microdebrider-assisted SBVR was performed during the turbinate surgery .\
RESULTS	The nasal symptoms , including nasal obstruction , rhinorrhea , itching , and sneezing , had significantly improved at 3 months after treatment in both groups ( P < 0.001 ) .\
RESULTS	Improvement of nasal obstruction in the SBR group was greater than that in the ITR group at 3 months ( P < 0.05 ) .\
RESULTS	Acoustic rhinometry demonstrated a significant increase in the cross-sectional area and nasal volume in both groups 3 months after surgery .\
RESULTS	The postoperative change in nasal volume was higher in the SBR group ( P < 0.05 ) .\
RESULTS	No adverse reactions such as bleeding , infection , adhesions , or olfactory changes were encountered in the SBR group .\
CONCLUSIONS	Combined SBVR and turbinoplasty appears to be more effective than turbinoplasty alone for the treatment of nasal obstruction in patients with inferior turbinate and septal body hypertrophy .\
\
###23246081\
OBJECTIVE	Peripheral arterial disease ( PAD ) has been associated with skeletal muscle pathology , including atrophy of the affected muscles .\
OBJECTIVE	In addition , oxidative metabolism is impaired , muscle function is reduced , and gait and mobility are restricted .\
OBJECTIVE	We hypothesized that greater severity of symptomatic PAD would be associated with lower levels of muscle mass , strength , and endurance , and that these musculoskeletal abnormalities in turn would impair functional performance and walking ability in patients with PAD .\
METHODS	We assessed 22 persons with intermittent claudication from PAD in this cross-sectional pilot study .\
METHODS	Outcome assessments included initial claudication distance and absolute claudication distance via treadmill protocols and outcomes from the 6-minute walk ( 6MW ) .\
METHODS	Secondary outcomes included one repetition maximum strength/endurance testing of hip extensors , hip abductors , quadriceps , hamstrings , plantar flexors , pectoral , and upper back muscle groups , as well as performance-based tests of function .\
METHODS	Univariate and stepwise multiple regression models were constructed to evaluate relationships and are presented .\
RESULTS	Twenty-two participants ( 63.6 % male ; mean [ standard deviation ] age , 73.6 [ 8.2 ] years ; range , 55-85 years ) were studied .\
RESULTS	Mean ( standard deviation ) resting ankle-brachial index ( ABI ) was 0.54 ( [ 0.13 ] ; range , 0.28-0 .82 ) , and participants ranged from having mild claudication to rest pain .\
RESULTS	Lower resting ABI was significantly associated with reduced bilateral hip extensor strength ( r = 0.54 ; P = .007 ) and reduced whole body strength ( r = 0.32 ; P = .05 ) .\
RESULTS	In addition , lower ABI was associated with a shorter distance to first stop during the 6MW ( r = 0.38 ; P = .05 ) and poorer single leg balance ( r = 0.44 ; P = .03 ) .\
RESULTS	Reduced bilateral hip extensor strength was also significantly associated with functional outcomes , including reduced 6MW distance to first stop ( r = 0.74 ; P = .001 ) , reduced 6MW distance ( r = 0.75 ; P < .001 ) , and reduced total short physical performance battery score ( worse function ; r = 0.75 ; P = .003 ) .\
CONCLUSIONS	Our results suggest the existence of a causal pathway from a reduction in ABI to muscle atrophy and weakness , to whole body disability represented by claudication outcomes and performance-based tests of functional mobility in an older cohort with symptomatic PAD .\
CONCLUSIONS	Longitudinal outcomes from this study and future trials are required to investigate the effects of an anabolic intervention targeting the muscles involved in mobility and activities of daily living and whether an increase in muscle strength will improve symptoms of claudication and lead to improvements in other functional outcomes in patients with PAD .\
\
###12969204\
OBJECTIVE	To compare the effectiveness of three dosing regimens of caffeine for preterm infants in the periextubation period .\
METHODS	A randomized double-blind clinical trial of three dosing regimens of caffeine citrate ( 3 , 15 and 30 mg/kg ) for periextubation management of ventilated preterm infants was undertaken .\
METHODS	Infants born < 32 weeks gestation who were ventilated for > 48 h were eligible for the study .\
METHODS	Caffeine citrate was given as a once daily dose for a period of 6 days commencing 24 h prior to a planned extubation , or within 6 h of an unplanned extubation .\
METHODS	The primary outcome measure was extubation failure , defined as neonates who were unable to be extubated within 48 h of caffeine loading or who required reventilation or doxapram dose within 7 days of caffeine loading .\
METHODS	Continuous recordings of oxygen saturation and heart rate were undertaken in a subgroup of enrolled infants .\
RESULTS	A total of 127 babies were enrolled into the study ( 42 , 40 , 45 , in the 3 , 15 , and 30 mg/kg groups , respectively ) .\
RESULTS	No statistically significant difference was demonstrated in the incidence of extubation failure between dosing groups ( 19 , 10 , and 11 infants in the 3 , 15 , and 30 mg/kg groups , respectively ) , however , infants in the two higher dose groups had statistically significantly less documented apnoea than the lowest dose group .\
RESULTS	Of the 37 neonates with continuous pulse oximetry recordings , those on higher doses of caffeine recorded a statistically significantly higher mean heart rate , oxygen saturations and less time with oxygen saturations < 85 % .\
CONCLUSIONS	This trial indicated there were short-term benefits of decreased apnoea in the immediate periextubation period for ventilated infants born < 32 weeks gestation receiving higher doses of caffeine .\
CONCLUSIONS	Further studies with larger numbers of infants assessing longer-term outcomes are necessary to determine the optimal dosing regimen of caffeine in preterm infants .\
\
###17558046\
BACKGROUND	Efficacy of topical methotrexate in psoriasis is limited by its penetration .\
OBJECTIVE	The study involved the preparation of niosomal methotrexate in chitosan gel and to test the same for irritation and sensitization on healthy human volunteers followed by assessing the efficacy of the gel through double-blind placebo-controlled study on psoriasis patients and also comparing its efficacy with a marketed methotrexate gel .\
METHODS	The methotrexate niosomes were prepared by lipid layer hydration method .\
METHODS	The characterized niosomes were incorporated in chitosan gel .\
METHODS	The gels were tested on 10 human volunteers to check for irritation and skin sensitivity by human repeated insult patch test ( HRIPT ) .\
METHODS	The formulations were assessed for efficacy by double-blind placebo-controlled study in 10 psoriasis patients for each formulation .\
METHODS	The efficacy was calculated by psoriasis area and severity index scoring method .\
METHODS	The global score was used to assess the progress of the disease .\
RESULTS	The HRIPT test did not produce any significant irritation or sensitization on healthy human volunteers .\
RESULTS	The placebo and marketed gels were compared with niosomal methotrexate gel .\
RESULTS	At Week 12 , with niosomal methotrexate gel , there was reduction in total score from 6.2378 + / -1.4857 to 2.0023 + / -0.1371 .\
CONCLUSIONS	These results suggest that niosomal methotrexate gel is more efficacious than placebo and marketed methotrexate gel .\
\
###17653691\
OBJECTIVE	Low HDL-cholesterol ( HDL-C ) is frequently accompanied by high triacylglycerol levels in diabetic dyslipidaemia , increasing the risk of CHD .\
OBJECTIVE	In the Fenofibrate Intervention and Event Lowering in Diabetes ( FIELD ) study , fenofibrate treatment lowered triacylglycerol levels , but the initial 5 % increase in HDL-C attenuated over 5 years .\
OBJECTIVE	We explored the changes in VLDL and HDL subspecies during fenofibrate treatment in a statin-free FIELD cohort .\
METHODS	We randomised 171 participants with type 2 diabetes mellitus , who had been recruited to the FIELD study in Helsinki , to micronised fenofibrate ( 200 mg/day ) or placebo in double-blind study design .\
METHODS	VLDL and HDL subspecies were separated by ultracentrifugation at baseline and at the second and fifth year .\
METHODS	Apolipoprotein ( apo ) A-I and apoA-II were measured by immunoturbidometric methods and lipoprotein ( Lp ) A-I and LpAI-AII particles by differential immunoassay .\
RESULTS	Fenofibrate reduced plasma triacylglycerol levels by 26 % , resulting from a marked reduction in VLDL1 triacylglycerol ( 0.62 vs 0.29 mmol/l , p < 0.001 ) .\
RESULTS	Fenofibrate caused an increase in LDL size ( Delta 0.80 nm , p < 0.001 ) .\
RESULTS	HDL-C was similar between the groups .\
RESULTS	HDL2-C was decreased by fenofibrate ( -27.5 % at 5th year , p < 0.001 ) and HDL3-C increased ( 13.0 % at 5th year , p < 0.001 ) .\
RESULTS	Fenofibrate had no effect on apoA-I , whereas apoA-II increased .\
RESULTS	Thus , LpA-I decreased while LpAI-AII increased .\
RESULTS	Activities of cholesteryl ester transfer protein , phospholipids transfer protein and lecithin : cholesterylacyl transferase were unchanged by fenofibrate .\
RESULTS	High homocysteine levels were associated with a slight decrease in HDL-C and apoA-I .\
CONCLUSIONS	Fenofibrate markedly reduced large VLDL particles and produced a clear shift in HDL subspecies towards smaller particles .\
CONCLUSIONS	The HDL3-C increase in conjunction with unchanged apoA-I [ corrected ] levels is a dilemma with regard to cardiovascular disease .\
\
###20101174\
OBJECTIVE	We hypothesized that laparoscopic cholecystectomy performed within 48 hours of admission for mild gallstone pancreatitis , regardless of resolution of abdominal pain or abnormal laboratory values , would result in a shorter hospital stay .\
BACKGROUND	Although there is consensus among surgeons that patients with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence , the precise timing of laparoscopic cholecystectomy for mild disease remains controversial .\
METHODS	Consecutive patients with mild pancreatitis ( Ranson score < or = 3 ) were prospectively randomized to either an early laparoscopic cholecystectomy group ( within 48 hours of admission ) versus a control laparoscopic cholecystectomy group ( performed after resolution of abdominal pain and normalizing trend of laboratory enzymes ) .\
METHODS	The primary end point was hospital length of stay .\
METHODS	Secondary end point was a composite of rates of conversion to an open procedure , perioperative complications , and need for endoscopic retrograde cholangiography .\
METHODS	The study was designed to enroll 100 patients with an interim analysis after 50 patients .\
RESULTS	At interim analysis , 50 patients were enrolled at a single university-affiliated public hospital .\
RESULTS	Of them , 25 patients were randomized to the early group and 25 patients to the control group .\
RESULTS	Patient age ranged from 18 to 74 years with a median duration of symptoms of 2 days upon presentation and a median Ranson score of 1 .\
RESULTS	There were no baseline differences between the groups with regards to demographics , clinical presentation , or the presence of comorbidities .\
RESULTS	The hospital length of stay was shorter for the early cholecystectomy group ( mean : 3.5 [ 95 % CI , 2.7-4 .3 ] , median : 3 [ IQR , 2-4 ] ) compared with the control group ( mean : 5.8 [ 95 % CI , 3.8-7 .9 ] , median : 4 [ IQR , 4-6 ] [ P = 0.0016 ] ) .\
RESULTS	Six patients from the early group required endoscopic retrograde cholangiography , compared with 4 in the control group ( P = 0.72 ) .\
RESULTS	There was no statistically significant difference in the need for conversion to an open procedure or in perioperative complication rates between the 2 groups .\
CONCLUSIONS	In mild gallstone pancreatitis , laparoscopic cholecystectomy performed within 48 hours of admission , regardless of the resolution of abdominal pain or laboratory abnormalities , results in a shorter hospital length of stay with no apparent impact on the technical difficulty of the procedure or perioperative complication rate .\
\
###14648521\
BACKGROUND	Physiologic and behavioral responses to procedural pain are influenced by gestational age ( GA ) .\
BACKGROUND	Compared with term neonates , hospitalized preterm neonates are subjected to more painful procedures aimed at improving their clinical outcome .\
BACKGROUND	Although several trials to determine the efficacy of sucrose for managing procedural pain have been conducted , none have examined the influence of GA. .\
OBJECTIVE	To examine the influence of GA on the efficacy and short-term safety of oral sucrose for relieving procedural pain associated with heel lances .\
OBJECTIVE	To explore GA differences in behavioral and physiologic indicators of pain .\
METHODS	As part of a larger randomized controlled trial ( RCT ) to examine the efficacy and safety of sucrose during heel lance , 190 neonates were stratified by GA : ( a ) 27 to 316/7 weeks ( group 1 ; n = 63 ) , ( b ) 32 to 356/7 weeks ( group 2 ; n = 63 ) , and ( c ) > 36 weeks ( group 3 ; n = 64 ) .\
METHODS	They were then randomized to receive ( a ) oral sucrose and non-nutritive sucking ( NNS ) , ( b ) sucrose alone , or ( c ) sterile water and NNS ( control ) for a heel lance .\
METHODS	The influence of GA was determined by examining the short-term safety , as defined by the number of associated adverse events ( choking , coughing or vomiting , sustained tachycardia , sustained tachypnea or dyspnea , or sustained oxygen desaturation ) .\
METHODS	The efficacy was measured by changes in a validated pain measure , scored during each phase of the intervention and analyzed according to GA groups .\
RESULTS	Significant differences in pain response existed in each GA group , with the lowest mean pain scores in the sucrose and NNS group .\
RESULTS	Significant GA differences in behavioral and physiologic responses were found , with the most mature neonates demonstrating the greatest magnitude of pain response .\
RESULTS	The greatest number of short-term adverse effects to treatment occurred in the lowest GA group .\
CONCLUSIONS	In a secondary analysis of a larger RCT , sucrose and NNS was the most efficacious intervention for single heel lances in each of 3 GA groups .\
CONCLUSIONS	However , infants of lower GA experienced more adverse events .\
CONCLUSIONS	Research on the efficacy and safety of repeated doses of oral sucrose , tested in infants from a wide range of GA , is required .\
\
###1469177\
OBJECTIVE	To evaluate the effect of a method of Selective Decontamination of the Digestive Tract ( SDD ) on colonization , nosocomial infection ( NI ) , bacterial resistance , mortality and economic costs .\
METHODS	Randomized , double blind , placebo controlled study .\
METHODS	Polyvalent intensive care unit ( ICU ) of a tertiary care hospital with 27 beds .\
METHODS	101 patients with > 3 days of mechanical ventilation and > 5 days of stay , without infection at the start of the study .\
METHODS	47 belonged to the Treated Group ( TG ) and 54 to the Placebo Group ( PG ) .\
METHODS	The TG was given Cefotaxime i.v. ( 6 g/day ) for the first four days and an association of Polymyxin E , Tobramycin and Amphotericin B at the oropharyngeal and gastrointestinal level throughout the whole stay .\
RESULTS	In the TG , colonization by gram-negative agents at oropharyngeal , tracheal and gastrointestinal level fell significantly .\
RESULTS	There was a significant drop in the overall , respiratory and urinary NI ( 26 % vs 63 % , p < 0.001 ; 15 % vs 46 % , p < 0.001 ; 9 % vs 31 % , p < 0.01 ) .\
RESULTS	The overall mortality and NI related mortality was less in the TG ( 21 % vs 44 % , p < 0.05 ; 2 % vs 20 % , p < 0.01 ) .\
RESULTS	The economic costs , mechanical ventilation time and length of stay were similar .\
RESULTS	The percentage of bacterial isolations resistant to Cefotaxime and Tobramycin was greater in the TG ( 38 % vs 15 % and 38 % vs 9 % , p < 0.001 ) .\
CONCLUSIONS	colonization by gram-negative bacilli , NI and the mortality related to it can be modified by SDD .\
CONCLUSIONS	Continuous bacteriological surveillance is necessary .\
\
###18346603\
OBJECTIVE	To determine whether playing music or blocking noise can reduce bispectral index ( BIS ) values during propofol sedation .\
METHODS	Prospective , randomized , single-blinded study .\
METHODS	Operating room .\
METHODS	63 ASA physical status I and II patients , aged 55 to 75 years , undergoing total knee replacement .\
METHODS	Patients were divided into three groups : noise , silence , and music .\
METHODS	After induction of combined spinal-epidural anesthesia , sedation was begun with 1.2 mug/mL of propofol in a target-controlled infusion .\
METHODS	In the silence group , patients ' ears were packed tightly to block ambient noise , whereas patient-selected music was applied to patients in the music group .\
METHODS	Patients in the noise group were exposed to ambient operating room noise .\
METHODS	Bispectral index measurement was recorded 7 times during operation .\
METHODS	Ambient room noise was recorded at the same time sequence .\
RESULTS	Sound level was highest when the saw ( T3 , 80.25 dB ) and the impact device ( T4 , 80.98 dB ) were in use .\
RESULTS	Bispectral index scores in the silence group during those times ( T3 , 68.5 vs 76.9 , P = 0.025 , and T4 , 67.6 vs 78 , P = 0.005 ) were lower than in the noise group .\
RESULTS	However , BIS scores were similar in the noise and music groups .\
RESULTS	Preoperative anxiety level , postoperative comfort level , and pain scores were similar in all groups .\
CONCLUSIONS	Blocking noise is more effective than playing music in reducing BIS scores during propofol sedation in a noisy environment .\
\
###23880826\
BACKGROUND	Radical three-dimensional conformal radiotherapy ( CFRT ) with initial androgen suppression ( AS ) is a standard management for localised prostate cancer ( PC ) .\
BACKGROUND	This pilot study evaluated the role of dose escalation and appropriate target volume margin .\
BACKGROUND	Here , we report long-term follow-up .\
METHODS	Eligible patients had T1b-T3b N0 M0 PC .\
METHODS	After neoadjuvant AS , they were randomised to CFRT , giving ( a ) 64Gy with either a 1.0 - or 1.5-cm margin and ( b ) 10Gy boost to the prostate alone .\
RESULTS	One hundred and twenty-six men were randomised and treated .\
RESULTS	Median follow-up was 13.7 years .\
RESULTS	The median age was 66.6 years at randomisation .\
RESULTS	Median presenting prostate-specific antigen ( PSA ) was 14ngml ( -1 ) .\
RESULTS	Sixty-four out of 126 patients developed PSA failure .\
RESULTS	Forty-nine out of 126 patients restarted AS , 34 out of 126 developed metastases and 28 out of 126 developed castrate-resistant prostate cancer ( CRPC ) .\
RESULTS	Fifty-one out of 126 patients died ; 19 out of 51 died of PC .\
RESULTS	Median overall survival ( OS ) was 14.4 years .\
RESULTS	Although escalated dose results were favourable , no statistically significant differences were seen between the randomised groups ; PSA control ( hazard ratio ( HR ) : 0.77 ( 95 % confidence interval ( CI ) : 0.47-1 .26 ) ) , development of CRPC ( HR : 0.81 ( 95 % CI : 0.40-1 .65 ) ) , PC-specific survival ( HR : 0.59 ( 95 % CI :0.23 -1.49 ) ) and OS ( HR : 0.81 ( 95 % CI : 0.47-1 .40 ) ) .\
RESULTS	There was no evidence of a difference in PSA control according to margin size ( HR : 1.01 ( 95 % CI : 0.61-1 .66 ) ) .\
CONCLUSIONS	Long-term follow-up of this small pilot study is compatible with a benefit from dose escalation , but confirmation from larger trials is required .\
CONCLUSIONS	There was no obvious detriment using the smaller radiotherapy margin .\
\
###11532838\
OBJECTIVE	To establish the relation between recurrent peer victimisation and onset of self reported symptoms of anxiety or depression in the early teen years .\
METHODS	Cohort study over two years .\
METHODS	Secondary schools in Victoria , Australia .\
METHODS	2680 students surveyed twice in year 8 ( aged 13 years ) and once in year 9 .\
METHODS	Self reported symptoms of anxiety or depression were assessed by using the computerised version of the revised clinical interview schedule .\
METHODS	Incident cases were students scoring > / = 12 in year 9 but not previously .\
METHODS	Prior victimisation was defined as having been bullied at either or both survey times in year 8 .\
RESULTS	Prevalence of victimisation at the second survey point in year 8 was 51 % ( 95 % confidence interval 49 % to 54 % ) , and prevalence of self reported symptoms of anxiety or depression was 18 % ( 16 % to 20 % ) .\
RESULTS	The incidence of self reported symptoms of anxiety or depression in year 9 ( 7 % ) was significantly associated with victimisation reported either once ( odds ratio 1.94 , 1.1 to 3.3 ) or twice ( 2.30 , 1.2 to 4.3 ) in year 8 .\
RESULTS	After adjustment for availability of social relations and for sociodemographic factors , recurrent victimisation remained predictive of self reported symptoms of anxiety or depression for girls ( 2.60 , 1.2 to 5.5 ) but not for boys ( 1.36 , 0.6 to 3.0 ) .\
RESULTS	Newly reported victimisation in year 9 was not significantly associated with prior self report of symptoms of anxiety or depression ( 1.48 , 0.4 to 6.0 ) .\
CONCLUSIONS	A history of victimisation and poor social relationships predicts the onset of emotional problems in adolescents .\
CONCLUSIONS	Previous recurrent emotional problems are not significantly related to future victimisation .\
CONCLUSIONS	These findings have implications for how seriously the occurrence of victimisation is treated and for the focus of interventions aimed at addressing mental health issues in adolescents .\
\
###17276750\
BACKGROUND	Methylphenidate has been shown elsewhere to improve hyperactivity in about half of treated children who have pervasive developmental disorders ( PDD ) and significant hyperactive-inattentive symptoms .\
BACKGROUND	We present secondary analyses to better define the scope of effects of methylphenidate on symptoms that define attention-deficit/hyperactivity disorder ( ADHD ) and oppositional defiant disorder ( ODD ) , as well as the core autistic symptom domain of repetitive behavior .\
METHODS	Sixty-six children ( mean age 7.5 y ) with autistic disorder , Asperger 's disorder , and PDD not otherwise specified , were randomized to varying sequences of placebo and three different doses of methylphenidate during a 4-week blinded , crossover study .\
METHODS	Methylphenidate doses used approximated .125 , .25 , and .5 mg/kg per dose , twice daily , with an additional half-dose in the late afternoon .\
METHODS	Outcome measures included the Swanson , Nolan , and Pelham Questionnaire revised for DSM-IV ( ADHD and ODD scales ) and the Children 's Yale-Brown Obsessive Compulsive Scales for PDD .\
RESULTS	Methylphenidate was associated with significant improvement that was most evident at the .25 - and .5 - mg/kg doses .\
RESULTS	Hyperactivity and impulsivity improved more than inattention .\
RESULTS	There were not significant effects on ODD or stereotyped and repetitive behavior .\
CONCLUSIONS	Convergent evidence from different assessments and raters confirms methylphenidate 's efficacy in relieving ADHD symptoms in some children with PDD .\
CONCLUSIONS	Optimal dose analyses suggested significant interindividual variability in dose response .\
\
###21486552\
BACKGROUND	With the increase of troops entering the plateau for a variety of missions , the occurrence of de-adaptation increased significantly when the army returned to the plains , however , until now , there has been no effective treatment for de-adaptation to high altitude .\
OBJECTIVE	To observe the interventional effects of compound Chinese herbal preparations ( Sankang Capsule , Rhodiola Rosea Capsule and Shenqi Pollen Capsule ) on de-adaptation to high altitude , and provide scientific evidence for appropriate treatment methods in the army health care for future missions .\
METHODS	A randomized , single-blind , placebo-controlled trial design was used .\
METHODS	Soldiers of a returning army unit who exhibited de-adaptation response symptoms were selected for observation after participating in earthquake relief at high altitude .\
METHODS	A total of 543 soldiers were divided into a Sankang Capsule group , a Rhodiola Rosea Capsule group , a Shenqi Pollen Capsule group and a placebo group for drug intervention and administered with corresponding drugs .\
METHODS	The course of treatment was 15 days .\
METHODS	A self-evaluation scale for de-adaptation to high altitude was used to measure the signs and symptoms exhibited by the soldiers .\
METHODS	Effective rate of signs and symptoms of de-adaptation to high altitude was analyzed after a 15-day treatment and the differences of improvement rate of symptoms between groups were compared to evaluate the efficacy of the drugs .\
RESULTS	All three drugs improved the symptoms of de-adaptation to high altitude .\
RESULTS	Compared with the placebo group , symptoms of de-adaptation to high altitude in the drug-treated groups were remitted ( P < 0.05 ) .\
RESULTS	Compared with placebo , Sankang Capsule mainly had well-marked effects on dizziness , fatigue , palpitations , cough , sputum and sore throat ( P < 0.05 ) ; Rhodiola Rosea Capsule significantly reduced the symptoms of fatigue , drowsiness , chest tightness , palpitations , vertigo , lack of attention and memory loss ( P < 0.05 ) ; Shenqi Pollen Capsule significantly reduced the symptoms of dizziness , fatigue , weakness , chest tightness , palpitations , cough , sputum , sore throat , memory loss , unresponsiveness and limb numbness ( P < 0.05 ) .\
RESULTS	The symptom improvement rate of Shenqi Pollen Capsule was significantly higher than those of the other two drugs .\
CONCLUSIONS	All the three drugs played an evident role in ameliorating symptoms of de-adaptation , and the use of Shenqi Pollen Capsule was more effective than Rhodiola Rosea Capsule and Sankang Capsule .\
\
###19730254\
OBJECTIVE	In acute respiratory distress syndrome , alveolar recruitment improves gas exchange only if perfusion of the recruited alveolar units is adequate .\
OBJECTIVE	To evaluate functional recruitment induced by positive end-expiratory pressure , we assessed pulmonary conductance for gas exchange based on lung diffusion for carbon monoxide and its components , including pulmonary capillary blood volume .\
METHODS	Prospective , randomized , crossover study .\
METHODS	Medical intensive care unit of a university hospital .\
METHODS	Sixteen patients with lung injury/acute respiratory distress syndrome as well as eight control patients under invasive ventilation and eight healthy volunteers .\
METHODS	Mechanical ventilation with two levels of positive end-expiratory pressure ( 5 and 15 cm H2O ) .\
RESULTS	Lung diffusion for carbon monoxide and lung volumes , arterial blood gas analysis , and pressure-volume curves .\
RESULTS	In patients with acute respiratory distress syndrome , high positive end-expiratory pressure induced a 23 % mean lung diffusion for carbon monoxide increase ( 4.4 + / - 1.7 mm Hg .\
RESULTS	min vs. 3.6 + / - 1.4 mL .\
RESULTS	mm Hg .\
RESULTS	min ) .\
RESULTS	In control patients and in healthy volunteers , lung diffusion for carbon monoxide values were ( median [ interquartile range ] ) 5.5 [ 3.8-8 .0 ] mm Hg .\
RESULTS	min and 19.6 [ 15.1-20 .6 ] mL .\
RESULTS	mm Hg .\
RESULTS	min , respectively .\
RESULTS	Among patients with acute respiratory distress syndrome , eight showed a > 20 % lung diffusion for carbon monoxide increase ( responders ) when increasing positive end-expiratory pressure .\
RESULTS	In the other eight , lung diffusion for carbon monoxide decreased or showed a < 5 % increase ( nonresponders ) with high positive end-expiratory pressure .\
RESULTS	Compared with nonresponders , responders at low positive end-expiratory pressure had smaller lungs with higher capillary blood volume-to-lung-volume ratio , higher values of the lower inflection point , and significantly greater increases in pulmonary capillary blood volume with high positive end-expiratory pressure .\
RESULTS	High positive end-expiratory pressure increased PaO2/Fio2 only in the responders .\
CONCLUSIONS	The functional response to positive end-expiratory pressure in patients with acute lung injury/acute respiratory distress syndrome seems better when the lungs are smaller and with a higher capillary blood-volume-to-lung-volume ratio .\
CONCLUSIONS	Lung diffusion for carbon monoxide measurement supplies additional information about functional lung recruitment , which is not synonymous with mechanical recruitment .\
\
###9175948\
OBJECTIVE	To evaluate the efficiency and side effects of ibuprofen for the early treatment of patent ductus arteriosus ( PDA ) and compare it with indomethacin .\
METHODS	Forty preterm infants with gestational ages of less than 33 weeks , with respiratory distress syndrome ( RDS ) and echocardiographically confirmed PDA , were randomly assigned at days 2 to 3 of life to receive either intravenous indomethacin 3 x 0.2 mg/kg at 12 hour intervals or intravenous ibuprofen 1 x 10 mg/kg , followed by 5 mg/kg 24 and 48 hours later .\
RESULTS	PDA closed in 15 of 20 patients from the indomethacin group ( 75 % ) and in 16 of 20 ( 80 % ) from the ibuprofen group .\
RESULTS	Seven patients ( three indomethacin , four ibuprofen ) required a second treatment with indomethacin and in five ( three in the indomethacin group and two in the ibuprofen group ) the duct was ultimately ligated .\
RESULTS	Ibuprofen patients had a better urinary output and showed no increase in serum creatinine concentrations compared with the indomethacin group .\
RESULTS	Ibuprofen was not associated with any other side effect .\
CONCLUSIONS	Ibuprofen treatment seems to be as efficient as indomethacin in closing PDA on the third day of life in preterm infants with respiratory distress syndrome and seems to have fewer renal side effects .\
\
###16413442\
BACKGROUND	Numerous preclinical and clinical studies have reported on the use of platelet concentrates to promote tissue healing .\
BACKGROUND	The results in spinal fusion applications are limited and controversial .\
OBJECTIVE	The purpose of the current prospective clinical cohort study is to assess the effect of Autologous Growth Factors ( AGF ) on lumbar interbody fusion with specific attention paid to determination of clinical and radiographic outcomes .\
METHODS	Prospective clinical study\
METHODS	Candidates for anterior-posterior lumbar fusion with diagnosis of degenerative disc disease and/or up to grade I spondylolytic spondylolisthesis based on positive provocative discography .\
METHODS	Clinical ( visual analogue pain scale/functional outcome assessment ) and radiographic outcomes ( fusion on computed tomography at 6 months and plain radiographs at 12 and 24 months ) .\
METHODS	Thirty-seven patients were assigned to standard anterior-posterior interbody fusion L2-S1 ( single or two-level ) using iliac crest bone graft ( autograft group : 22 patients with 32 levels operated ) or allograft combined with autogenous growth factors ( AGF group : 15 patients with 25 levels operated ) .\
METHODS	Radiographic outcomes were collected at 6 months postsurgery with computed tomography and at 12 and 24 months with plain radiographs .\
METHODS	Pre - and postoperative clinical outcome measures included visual analog scores ( VAS ) for back and leg pain ( 0-10 ) , SF-36 scores , and Oswestry disability determination .\
METHODS	Average clinical and radiographic follow-up for the autograft group was 24.3 + / -5.6 months ( 12-36 months ) and AGF was 25.7 + / -7.5 ( 6-40 months ) .\
RESULTS	Fusion incorporation at each end plate was determined at 56 % in both autograft and AGF ( p = NS ) patients based on computed tomography at 6 months with minimal subsidence noted and no direct correlation between the incidence or degree of cage subsidence and bone graft technique .\
RESULTS	The 12 - and 24-month radiographic results confirmed an 85 % arthrodesis rate for the autograft patients , whereas the AGF patients had an 89 % fusion rate ( p = NS ) .\
RESULTS	Clinical outcomes were similar for both groups and no significant differences were noted for pain or functional outcome improvements .\
CONCLUSIONS	AGF combined with an allograft carrier is equivalent in radiographic and clinical outcomes to autograft in one - or two-level lumbar interbody fusion with supplemental posterior fixation and , thus , eliminates any morbidity from iliac crest bone graft harvesting .\
CONCLUSIONS	AGF combined with an appropriate carrier is a reasonable alternative to autograft and expensive bone induction technologies .\
CONCLUSIONS	Further research is still required to examine the optimum carriers , preparation and formulation , and platelet concentrations for this technology .\
\
###23782594\
OBJECTIVE	We examined the efficacy , safety and tolerability of canagliflozin , a sodium glucose co-transporter 2 inhibitor , in Japanese patients with type 2 diabetes ( T2DM ) undergoing diet and exercise therapy .\
METHODS	Patients aged 20-80years with T2DM diagnosed 3months previously , and HbA1c of 6.9-9 .9 % were randomized to 50 , 100 , 200 or 300mg canagliflozin or placebo once daily for 12weeks .\
METHODS	The primary and secondary endpoints were changes in HbA1c , fasting plasma glucose ( FPG ) , urinary glucose/creatinine and postprandial glycaemic parameters following a meal test .\
METHODS	The safety assessments included adverse events ( AEs ) and clinical laboratory tests .\
RESULTS	Overall , 383 patients were randomized to receive either placebo ( n = 75 ) , or 50mg ( n = 82 ) , 100mg ( n = 74 ) , 200mg ( n = 77 ) or 300mg canagliflozin ( n = 75 ) .\
RESULTS	At week 12 , significant reductions in HbA1c were observed in all canagliflozin groups relative to placebo ( -0.61 , -0.80 , -0.79 and -0.88 % for 50 , 100 , 200 and 300mg , respectively , versus +0.11 % for placebo ; all , p < 0.01 ) .\
RESULTS	FPG and postprandial glycaemic parameters improved significantly in the canagliflozin groups .\
RESULTS	Body weight was significantly decreased by canagliflozin .\
RESULTS	No deaths or drug-related serious AEs were reported .\
RESULTS	There was no dose-dependent increase in the incidence of AEs in the canagliflozin groups .\
RESULTS	The incidence of hypoglycaemia was low ; episodes were not severe or dose dependent .\
RESULTS	Canagliflozin did not affect serum creatinine levels or the urinary albumin/creatinine ratio .\
CONCLUSIONS	Treatment with canagliflozin for 12weeks significantly improved glycaemic control and reduced body weight in Japanese patients with T2DM .\
CONCLUSIONS	Canagliflozin was well tolerated .\
\
###21439030\
BACKGROUND	Malnutrition is very common in patients undergoing cardiac surgery .\
BACKGROUND	Malnutrition can change myocardial substrate utilization which can induce adverse effects on myocardial metabolism and function .\
BACKGROUND	We aim to investigate the hypothesis that there is a disturbed amino acids profile in the cardiac surgical patient which can be normalized by ( par ) enteral nutrition before , during and after surgery , subsequently improving cardiomyocyte structure , cardiac perfusion and glucose metabolism .\
METHODS	This randomized controlled intervention study investigates the effect of uninterrupted perioperative ( par ) enteral nutrition on cardiac function in 48 patients undergoing coronary artery bypass grafting .\
METHODS	Patients are given enteral nutrition ( n = 16 ) or parenteral nutrition ( n = 16 ) , at least two days before , during , and two days after coronary artery bypass grafting , or are treated according to the standard guidelines ( control ) ( n = 16 ) .\
METHODS	We will illustrate the effect of ( par ) enteral nutrition on differences in concentrations of amino acids and asymmetric dimethylarginine and in activity of dimethylarginine dimethylaminohydrolase and arginase in cardiac tissue and blood plasma .\
METHODS	In addition , cardiomyocyte structure by histological , immuno-histochemical and ultrastructural analysis will be compared between the ( par ) enteral and control group .\
METHODS	Furthermore , differences in cardiac perfusion and global left ventricular function and glucose metabolism , and their changes after coronary artery bypass grafting are evaluated by electrocardiography-gated myocardial perfusion scintigraphy and F-fluorodeoxy-glucose positron emission tomography respectively .\
METHODS	Finally , fat free mass is measured before and after intervention with bioelectrical impedance spectrometry in order to evaluate nutritional status .\
BACKGROUND	Netherlands Trial Register ( NTR ) : NTR2183 .\
\
###18560253\
BACKGROUND	Alcohol abuse serves as a chronic stressor between partners and has a deleterious effect on relationship functioning .\
BACKGROUND	Behavioral Couples Therapy ( BCT ) for alcohol dependence , studied as an adjunct to individual outpatient counseling , has shown to be effective in decreasing alcohol consumption and enhancing marital functioning , but no study has directly tested the comparative effectiveness of stand-alone BCT versus an individually focused cognitive-behavioral therapy ( CBT ) in a clinical community sample .\
METHODS	The present study is a randomized clinical trial evaluating the effectiveness of stand-alone BCT ( n = 30 ) compared to individual CBT ( n = 34 ) in the treatment of alcohol use disorders in community treatment centers in Dutch male and female alcoholics and their partners .\
RESULTS	Results show both BCT and CBT to be effective in changing drinking behavior after treatment .\
RESULTS	BCT was not found to be superior to CBT .\
RESULTS	Marital satisfaction of the spouse increased significantly in the BCT condition but not in the CBT condition , the differences being significant at the post-test .\
RESULTS	Patients ' self-efficacy to withstand alcohol-related high-risk situations increased significantly in both treatment conditions , but more so in CBT than in BCT after treatment .\
RESULTS	Treatment involvement of the spouse did not increase retention .\
CONCLUSIONS	Regular practitioners in community treatment centers can effectively deliver both treatments .\
CONCLUSIONS	Stand-alone BCT is as effective as CBT in terms of reduced drinking and to some extent more effective in terms of enhancing relationship satisfaction .\
CONCLUSIONS	However , BCT is a more costly intervention , given that treatment sessions lasted almost twice as long as individual CBT sessions .\
\
###22018594\
BACKGROUND	Long acting somatostatin analogues combined with platinum analogues have demonstrated an antiproliferative effect on growth of human SCLC xenographs .\
METHODS	130 previously untreated SCLC patients -- 54 with limited disease ( LD ) and positive somatostatin receptors were included in the study .\
METHODS	All patients performed 111In-Octreotide scanning before chemotherapy ( CHT ) , every 3 months and up to 4 times .\
METHODS	All patients were treated with paclitaxel 190 mg/m2 + carboplatin AUC = 5.5 for up to 6 cycles .\
METHODS	47/130 patients ( Group A , control group ) received only CHT .\
METHODS	Forty eight hours after each CHT 43/130 patients ( Group B ) were also administered 30 mg somatuline ( lanreotide ) by a single subcutaneous ( s.c. ) injection to stimulate somatostatin receptors ( SSTRS ) for 2 weeks .\
METHODS	40/130 patients ( Group C ) received 60 mg somatuline autogel to stimulate SSTRS for 4 weeks .\
METHODS	Patients in Groups A and B after the completion of the CHT continued maintenance therapy with somatuline .\
METHODS	NSE , IGF1 , VEGFA , VEGFC , VEGFR2 , HER2 levels were monitored .\
METHODS	In histological samples Bcl-2 and VEGF were also explored by immunohistochemistry .\
RESULTS	No statistically significant differences were observed between the 3 Groups regarding LD and extensive disease ( ED ) patient ratios , age and PS .\
RESULTS	Group B had a survival benefit in comparison to Groups A and C ( p = 0.029 ) .\
RESULTS	LD patients of Group B had a significant benefit compared to Groups A and C ( p = 0.012 , Breslow test ) .\
RESULTS	In LD Group B had a significant longer TTP ( p = 0.02 ) in comparison to Groups A and C. Adverse effects had no statistically significant difference between the Groups and toxicity was well managed .\
CONCLUSIONS	Long acting somatostatin analogues could be used as an additive therapy in combination to antineoplastic agents in patients positive for somatostatin receptors .\
CONCLUSIONS	A dose of 30 mg improved survival only in LD SCLC patients .\
\
###21722188\
OBJECTIVE	To test whether or not transmucosal healing at two-piece implants is as successful as submerged placement regarding crestal bone levels and patient satisfaction .\
METHODS	Adults requiring implants in the anterior maxilla or mandible in regions 21-25 , 11-15 , 31-35 or 41-45 ( WHO ) were recruited for this randomized , controlled multi-center clinical trial of a 5-year duration .\
METHODS	Randomization was performed at implantation allowing for either submerged or transmucosal healing .\
METHODS	Final reconstructions were seated 6 months after implantation .\
METHODS	Radiographic interproximal crestal bone levels and peri-implant soft tissue parameters were measured at implant placement ( IP ) ( baseline ) , 6 and 12 months .\
METHODS	Patient satisfaction was assessed by a questionnaire .\
METHODS	A two-sided t-test ( 80 % power , significance level = 0.05 ) was performed on bone-level changes at 6 and 12 months .\
RESULTS	One hundred and twenty-seven subjects were included in the 12-month analysis ( submerged [ S ] : 52.5 % , transmucosal [ TM ] : 47.2 % ) .\
RESULTS	From IP to 6 months , the change in the crestal bone level was -0.32 mm ( P < 0.001 ) for the S group and -0.29 mm ( P < 0.001 ) for the TM group .\
RESULTS	From IP to 12 months , bone-level changes were statistically significant in both groups ( S -0.47 mm , P < 0.001 ; TM -0.48 mm , P < 0.001 ) .\
RESULTS	The mean differences of change in the bone levels between the two groups were not statistically significant at either time point , indicating the equivalence of both procedures .\
RESULTS	For both groups , very good results were obtained for soft tissue parameters and for patient satisfaction .\
CONCLUSIONS	Transmucosal healing of two-piece implants is as successful as the submerged healing mode with respect to tissue integration and patient satisfaction within the first 12 months after IP .\
\
###24506234\
OBJECTIVE	Increased interest in antiaging methods , mandates a development of reliable noninvasive technique to assess skin aging .\
OBJECTIVE	In this study , we aimed to determine the effects of photoaging at histopathologic resolution by means of reflectance confocal microscopy .\
METHODS	The sun-exposed malar area , the anterior aspect of ear lobule , and the sun-protected posterior aspect of ear lobule had been evaluated in 120 volunteers from different age groups over 10 previously reported and new confocal parameters for skin aging .\
RESULTS	The sun-exposed areas revealed more frequent irregular honeycomb pattern , polycylic papillary contours , coarse collagen , huddled collagen , curled bright structures with higher epidermal thickness , and furrow depth values .\
RESULTS	However , the incidence of thin reticulated collagen and the number of dermal papillae were statistically higher on the sun-protected posterior aspect of ear lobule .\
CONCLUSIONS	Reflectance confocal microscopy is a reliable diagnostic technique for evaluation of skin photoaging with objective criteria .\
CONCLUSIONS	With the new emerging compact models it is possible to scan even the least accessible body parts with no discomfort to the patient , which offers the possibility to assess the effect of antiaging applications and to identify early signs of solar damage in cosmetically sensitive areas .\
\
###17654322\
BACKGROUND	Protein-energy malnutrition and decreased quality of life ( QOL ) are common in hemodialysis ( HD ) patients .\
BACKGROUND	Although several studies have proved that regular exercise has beneficial effects , few control studies have shown the effects of exercise training on the nutritional status and QOL in HD patients .\
METHODS	Fifty-five HD patients were recruited , and 22 of them were trained to exercise on an ergometer prior to dialysis three times a week for one year .\
METHODS	Serum albumin levels , creatinine generation rate ( CGR ) , and the Short Form 36 were assessed as outcome measures .\
RESULTS	The serum albumin levels and CGR increased in the training group compared with baseline .\
RESULTS	The QOL scores also increased in half of the physical health and mental health dimensions in the training group .\
CONCLUSIONS	These observations suggest that low-dose , long-term pre-dialytic endurance training might reverse the poor clinical outcome by improving the nutritional status and QOL in HD patients .\
\
###15851216\
OBJECTIVE	The purpose of this study was to compare rate-only detection to enhanced detection in a dual-chamber implantable cardioverter-defibrillator ( ICD ) , to discriminate ventricular tachycardia from supraventricular tachycardia .\
BACKGROUND	ICDs are highly effective in treating ventricular tachycardia ( VT ) or ventricular fibrillation ( VF ) .\
BACKGROUND	However , they frequently deliver inappropriate therapy during supraventricular tachycardia ( SVT ) .\
METHODS	We conducted a randomized clinical trial of detection enhancements in a dual-chamber ICD compared to control ( rate-only ) detection to discriminate VT from SVT .\
METHODS	Detection enhancements included a specific standardized protocol identical for all patients for programming rate stability , sudden onset , atrial-to-ventricular relationship ( sudden onset = 9 % and rate stability = 10 ms ; V > A `` on '' ) , and `` sustained rate duration '' ( 3 minutes ) .\
METHODS	The primary endpoint was the time to first inappropriate therapy classified by a blinded events committee .\
RESULTS	One hundred forty-nine patients had a history of sustained VT or VF .\
RESULTS	Mean age ( + / - SD ) was 60 + / - 13 years ; 83 % were male , and mean ejection fraction was 35 + / - 15 % .\
RESULTS	Control ( n = 70 ) and `` enhanced '' ( n = 79 ) groups did not differ with regard to age , sex , ejection fraction , or primary arrhythmia .\
RESULTS	The proportion of patients free of inappropriate therapy over time was significantly higher in the enhanced versus the control group ( hazard ratio = 0.47 , P = .011 ) .\
RESULTS	High-energy shocks were reduced from 0.58 + / - 4.23 shocks/patient/month in the control group to 0.04 + / - 0.15 shocks/patient/month in the enhanced group ( P = .0425 ) .\
RESULTS	No patient programmed per protocol failed to receive therapy for VT detected by the ICD ( 422 VT episodes ) .\
CONCLUSIONS	Standardized programming in a dual-chamber ICD leads to a significant and clinically important reduction in inappropriate therapies compared to rate-only detection and does not compromise safety with respect to appropriate treatment of VT. .\
\
###24480106\
OBJECTIVE	Evaluate the sensitivity and specificity of pelvic ultrasound ( US ) and abdominopelvic computed tomography ( CT ) for the identification of ovarian torsion in women presenting to the emergency department with acute lower abdominal or pelvic pain .\
METHODS	This is a retrospective study of 20 cases of ovarian torsion and 20 control patients , all of whom had both US and CT performed in the emergency department .\
METHODS	Two radiologists who were blinded to clinical data interpreted all studies as ( 1 ) demonstrating an abnormal ovary or not , and ( 2 ) suggestive of torsion or not .\
METHODS	Sensitivity , specificity and interobserver variation were calculated for each imaging modality .\
RESULTS	Pelvic US was interpreted as demonstrating an abnormal ovary in 90.0 % of ovarian torsion cases by reader 1 , and in 100.0 % by reader 2 , whereas CT was interpreted as revealing an abnormal ovary in 100.0 % of torsion cases by both readers .\
RESULTS	Pelvic US for ovarian torsion was 80.0 % sensitive ( 95 % CI , 58.4-91 .9 % ) and 95.0 % specific ( 95 % CI , 76.4-99 .1 % ) for reader 1 , while 80.0 % sensitive ( 95 % CI , 58.4-91 .9 % ) and 85.0 % specific ( 95 % CI , 64.0-95 .0 % ) for reader 2 .\
RESULTS	Interobserver agreement for pelvic US was fair ( Kappa = 0.60 ) .\
RESULTS	Abdominopelvic CT for ovarian torsion was 100.0 % sensitive ( 95 % CI , 83.9-100 .0 % ) and 85.0 % specific ( 95 % CI , 64.0-94 .5 % ) for reader 1 , while 90.0 % sensitive ( 95 % CI , 69.9-97 .2 % ) and 90.0 % specific ( 95 % CI , 69.9-97 .2 % ) for reader 2 .\
RESULTS	Interobserver agreement was excellent ( Kappa = 0.85 ) .\
CONCLUSIONS	The diagnostic performance of CT is not shown to be significantly different from that of US in identifying ovarian torsion in this study .\
CONCLUSIONS	These results suggest that when CT demonstrates findings of ovarian torsion , the performance of another imaging exam ( i.e. US ) that delays therapy is unlikely to improve preoperative diagnostic yield .\
\
###11775301\
OBJECTIVE	To test the efficacy of an interactive coaching intervention to promote responsiveness between mothers experiencing postpartum depressive symptoms ( PPDS ) and their infants .\
METHODS	An experimental design with 117 postpartum women in the Northeastern United States .\
METHODS	Participants were randomly assigned either to the treatment or control group .\
METHODS	Both groups had home visits at 4-8 weeks , 10-14 weeks , and 14-18 weeks postpartum and mother-infant interaction was videotaped and coded for responsiveness .\
METHODS	The treatment group also received a coached behavioral intervention designed to promote maternal-infant responsiveness .\
METHODS	Measures included the Edinburgh Postnatal Depression Scale , the Beck Depression Inventory-II , and the Dyadic Mutuality Code .\
RESULTS	The hypothesis , that the treatment group would show significantly higher maternal-infant responsiveness after the intervention , was supported .\
RESULTS	No effect of the intervention on depression scores was found .\
RESULTS	A significant increase in responsiveness and a significant decrease in depression scores occurred over time for both treatment and control groups .\
RESULTS	No interaction between group and time was detected .\
CONCLUSIONS	The study showed that a coaching strategy had a positive effect on maternal-infant interaction in this sample .\
CONCLUSIONS	Future research is needed to test coaching interventions in conjunction with other strategies targeted to promote maternal-infant responsiveness and to reduce PPDS .\
\
###15515112\
BACKGROUND	Claims that laparoscopic groin hernia repair is followed by less persisting pain and numbness than open mesh repair were tested by follow-up within a multicentre randomized clinical trial .\
METHODS	Participants in the UK Medical Research Council Laparoscopic Groin Hernia Trial were followed up by means of self-completed postal questionnaires from 2 to 5 years after trial entry .\
METHODS	The principal measures were pain ( groin and testicular ) and numbness ( groin and thigh ) .\
RESULTS	Seven hundred and fifty ( 80.8 per cent ) of the original 928 participants returned at least one questionnaire between 2 and 5 years ; respondents were similar to the baseline randomized groups .\
RESULTS	Fewer respondents in the laparoscopic group had groin pain ( absolute differences varied between 7.9 and 2.0 per cent , but were of marginal statistical significance ) ; rates of testicular pain were similar in the two groups .\
RESULTS	Groin numbness was reported about half as commonly at all time points in the laparoscopic group ( P < 0.001 ) ; there were no significant differences in thigh numbness .\
CONCLUSIONS	Laparoscopic surgery was associated with less long-term numbness and probably less pain in the groin .\
\
###16413328\
OBJECTIVE	To evaluate the effect of alfuzosin in improving symptoms in , and quality of life of , patients with indwelling double-J ureteral stents .\
METHODS	A total of 100 patients , 50 men and 50 women ( mean age 54.2 years ) , with unilateral ureteral stone-related hydronephrosis , who had opted for conservative management with insertion of a double-J ureteral stent , were prospectively randomized into two groups .\
METHODS	Group 1 included 50 patients who received 10 mg of alfuzosin , once daily for 4 weeks , and group 2 consisted of 50 patients who received placebo for the same period .\
METHODS	All patients completed a validated Ureteral Stent Symptom Questionnaire ( USSQ ) 4 weeks after stent placement .\
RESULTS	The mean urinary symptom index score was 21.6 in group 1 and 28.1 in group 2 ( P < 0.001 ) .\
RESULTS	Stent-related pain was reported by 44 % of patients in group 1 and 66 % of patients in group 2 ( P = 0.027 ) .\
RESULTS	The mean pain index score was 14.6 in group 1 and 17.4 in group 2 ( P = 0.047 ) .\
RESULTS	The mean general health index score was statistically greater ( P < 0.001 ) in group 1 compared with in group 2 ( 8 versus 11.4 , respectively ) .\
RESULTS	Among sexually active patients , the mean sexual score was 2.3 in group 1 and 2.9 in group 2 ( P = 0.017 ) .\
CONCLUSIONS	Stent-related symptoms were present in 66 % of the controls ( group 2 ) .\
CONCLUSIONS	Alfuzosin improved a subset of stent-related urinary symptoms and pain .\
CONCLUSIONS	Patients receiving alfuzosin had their sexual function and general health better preserved .\
\
###19366849\
OBJECTIVE	Cholestatic liver dysfunction and biliary sludge are common problems in critically ill patients .\
OBJECTIVE	No specific strategies have been described to prevent cholestasis and biliary sludge in the intensive care unit ( ICU ) .\
OBJECTIVE	We examined liver dysfunction and biliary sludge prospectively in a large medical long-stay ICU population and hypothesized that tight glycemic control with intensive insulin therapy ( IIT ) reduces cholestasis and biliary sludge .\
METHODS	This study was a preplanned subanalysis of 658 long-stay ( at least a fifth day ) ICU patients out of a large randomized controlled trial ( n = 1200 ) , studying the effects of IIT on the outcome of medical critical illness .\
METHODS	Patients were allocated to either IIT ( glycemia 80-110 mg/dl ) or conventional insulin therapy ( CIT ) requiring insulin above a glycemia of 215 mg/dl .\
METHODS	Different patterns of liver dysfunction were studied based on daily blood sample analysis , and biliary sludge was evaluated by ultrasonography .\
RESULTS	On admission , cholestasis was present in 17 % of patients ( n = 649 ) , increasing to 20 % on d 10 ( n = 347 ) , whereas ischemic hepatitis decreased from 3.4 % ( n = 588 ) to less than 1 % ( n = 328 ) .\
RESULTS	IIT significantly decreased biliary sludge on d 5 ( 50.4 vs. 66.4 % , P = 0.01 ; n = 250 ) .\
RESULTS	The difference did not remain significant on d 10 ( 57.4 vs. 66.2 % , P = 0.29 ; n = 136 ) .\
RESULTS	IIT also lowered the cumulative risk of cholestasis ( P = 0.03 ) .\
CONCLUSIONS	Cholestatic liver dysfunction and biliary sludge are very common during prolonged critical illness but are significantly reduced by IIT .\
\
###21245884\
OBJECTIVE	Oxidative stress may induce insulin resistance in peripheral tissues and impair insulin secretion from pancreatic - cells .\
OBJECTIVE	Antioxidants are suggested to decrease the risk of diabetes through reduction of oxidative stress .\
OBJECTIVE	However , only a few studies exist on dietary antioxidants and the risk of type 2 diabetes .\
OBJECTIVE	We investigated the association of dietary antioxidants with incident type 2 diabetes in the - Tocopherol , - Carotene Cancer Prevention Study cohort .\
METHODS	The study cohort included 29,133 male smokers aged 50-69 years .\
METHODS	During a median follow-up of 10.2 years 660 incident cases of diabetes were observed among the 25,505 men with a completed baseline food frequency questionnaire .\
RESULTS	Dietary - tocopherol , - tocopherol and - tocotrienol were positively associated with the risk of diabetes when adjusted for age and supplementation ( relative risk ( RR ) 1.17 ( 95 % confidence interval ( CI ) 0.91-1 .51 ) P for trend 0.02 ; RR 1.31 ( 95 % CI 1.02-1 .68 ) P for trend 0.01 ; RR 1.28 ( 95 % CI 1.00-1 .63 ) P for trend 0.01 , respectively ) , but the association disappeared after multivariate adjustment ( RR 0.92 ( 95 % CI 0.71-1 .19 ) P for trend 0.97 ; RR 1.06 ( 95 % CI 0.82-1 .36 ) P for trend 0.48 ; RR 1.04 ( 95 % CI 0.80-1 .35 ) P for trend 0.46 , respectively ) .\
RESULTS	Other tocopherols and tocotrienols as well as vitamin C , carotenoids , flavonols and flavones had no association with risk of diabetes .\
CONCLUSIONS	Dietary antioxidants were not associated with a decreased risk of incident diabetes in middle-aged male smokers .\
\
###17130343\
BACKGROUND	Allopurinol has been shown to improve endothelial function in chronic heart failure .\
BACKGROUND	This study aimed to establish its mechanism of action and to construct a dose-response curve for the effect of allopurinol .\
RESULTS	Two randomized , placebo-controlled , double-blind , crossover studies were performed for 1 month on patients with New York Heart Association Class II-III chronic heart failure , comparing 300 mg allopurinol , 600 mg allopurinol , and placebo for the first study and 1000 mg probenecid versus placebo in the second study .\
RESULTS	Endothelial function was assessed by standard forearm venous occlusion plethysmography .\
RESULTS	Allopurinol 600 mg/d significantly increased forearm blood flow response to acetylcholine compared with both allopurinol 300 mg/d and placebo ( % change in forearm blood flow [ mean + / - SEM ] : 240.31 + / -38.19 % versus 152.10 + / -18.21 % versus 73.96 + / -10.29 % , P < 0.001 ) .\
RESULTS	For similar levels of urate lowering , the uricosuric agent probenecid had no effect on endothelial function .\
RESULTS	Sodium nitroprusside response was unchanged by all treatments .\
RESULTS	Vitamin C and acetylcholine coinfusion data showed that 600 mg/d allopurinol completely abolished the oxidative stress that was sensitive to high-dose vitamin C.\
CONCLUSIONS	For the first time , we have shown that a steep dose-response relationship exists between allopurinol and its effect on endothelial function .\
CONCLUSIONS	We also showed that the mechanism of improvement in endothelial function with allopurinol lies in its ability to reduce vascular oxidative stress and not in urate reduction .\
CONCLUSIONS	The reduction in vascular oxidative stress was profound because high-dose allopurinol totally abolished the oxidative stress that was sensitive to the high-dose vitamin C that was used in this study .\
\
###14984936\
BACKGROUND	Despite their low risk for recurrence , many women with endometrial adenocarcinoma receive postoperative radiation therapy ( RT ) .\
BACKGROUND	This study was developed to determine if adjunctive external beam irradiation lowers the risk of recurrence and death in women with endometrial cancer International Federation of Gynaecology and Obstetrics ( FIGO ) stages IB , IC , and II ( occult disease ) .\
METHODS	Four hundred forty-eight consenting patients with `` intermediate risk '' endometrial adenocarcinoma were randomized after surgery to either no additional therapy ( NAT ) or whole pelvic radiation therapy ( RT ) .\
METHODS	They were followed to determine toxicity , date and location of recurrence , and overall survival .\
METHODS	A high intermediate risk ( HIR ) subgroup of patients was defined as those with ( 1 ) moderate to poorly differentiated tumor , presence of lymphovascular invasion , and outer third myometrial invasion ; ( 2 ) age 50 or greater with any two risk factors listed above ; or ( 3 ) age of at least 70 with any risk factor listed above .\
METHODS	All other eligible participants were considered to be in a low intermediate risk ( LIR ) subgroup .\
RESULTS	Three hundred ninety-two women met all eligibility requirements ( 202 NAT , 190 RT ) .\
RESULTS	Median follow-up was 69 months .\
RESULTS	In the entire study population , there were 44 recurrences and 66 deaths ( 32 disease or treatment-related deaths ) , and the estimated 2-year cumulative incidence of recurrence ( CIR ) was 12 % in the NAT arm and 3 % in the RT arm ( relative hazard ( RH ) : 0.42 ; P = 0.007 ) .\
RESULTS	The treatment difference was particularly evident among the HIR subgroup ( 2-year CIR in NAT versus RT : 26 % versus 6 % ; RH = 0.42 ) .\
RESULTS	Overall , radiation had a substantial impact on pelvic and vaginal recurrences ( 18 in NAT and 3 in RT ) .\
RESULTS	The estimated 4-year survival was 86 % in the NAT arm and 92 % for the RT arm , not significantly different ( RH : 0.86 ; P = 0.557 ) .\
CONCLUSIONS	Adjunctive RT in early stage intermediate risk endometrial carcinoma decreases the risk of recurrence , but should be limited to patients whose risk factors fit a high intermediate risk definition .\
\
###16912120\
BACKGROUND	Recently we found that testosterone levels are higher in older men than young men receiving exogenous testosterone .\
BACKGROUND	We hypothesized that older men have lower apparent testosterone metabolic clearance rates ( aMCR-T ) that contribute to higher testosterone levels .\
OBJECTIVE	The objective of the study was to compare aMCR-T in older and young men and identify predictors of aMCR-T .\
METHODS	Sixty-one younger ( 19-35 yr ) and 60 older ( 59-75 yr ) men were given a monthly GnRH agonist and weekly testosterone enanthate ( TE ) ( 25 , 50 , 125 , 300 , or 600 mg ) for 5 months .\
METHODS	Estimated aMCR-T was calculated from the amount of TE delivered weekly and trough serum testosterone concentrations , corrected for real-time absorption kinetics from the im testosterone depot .\
RESULTS	Older men had lower total ( 316 + / - 13 vs. 585 + / - 26 ng/dl , P < 0.00001 ) and free testosterone ( 4 + / - 0.1 vs. 6 + / - 0.3 ng/dl , P < 0.00001 ) and higher SHBG ( 52 + / - 3 vs. 33 + / - 2 nmol/liter , P < 0.00001 ) than younger men at baseline .\
RESULTS	Total and free testosterones increased with TE dose and were higher in older men than young men in the 125 - , 300 - , and 600-mg dose groups .\
RESULTS	aMCR-T was lower in older men than young men ( 1390 + / - 69 vs. 1821 + / - 102 liter/d , P = 0.006 ) .\
RESULTS	aMCR-T correlated negatively with age ( P = 0.0007 ) , SHBG ( P = 0.046 ) , and total testosterone during treatment ( P = 0.02 ) and percent body fat at baseline ( P = 0.01 ) and during treatment ( P = 0.004 ) .\
RESULTS	aMCR-T correlated positively with lean body mass at baseline ( P = 0.03 ) and during treatment ( P = 0.01 ) .\
RESULTS	In multiple regression models , significant predictors of aMCR-T included lean body mass ( P = 0.008 ) , percent fat mass ( P = 0.009 ) , and SHBG ( P = 0.001 ) .\
CONCLUSIONS	Higher testosterone levels in older men receiving TE were associated with an age-related decrease in apparent testosterone metabolic clearance rates .\
CONCLUSIONS	Body composition and SHBG were significant predictors of aMCR-T .\
\
###25262324\
BACKGROUND	Increasing chest compression rate during cardiopulmonary resuscitation can affect the workload and , ultimately , the quality of chest compression .\
BACKGROUND	This study examines the effects of compression at the rate of as-fast-as-you-can on cardiopulmonary resuscitation ( CPR ) performance .\
METHODS	A crossover , randomized-to-order design was used .\
METHODS	Each participant performed chest compressions without ventilation on a manikin with 2 compression rates : 100 per minute ( 100-cpm ) and `` push as-fast-as you-can '' ( PF ) .\
METHODS	The participants performed chest compressions at a rate of either 100-cpm or PF and subsequently switched to the other after a 50-minute rest .\
RESULTS	Forty-two CPR-qualified nonprofessionals voluntarily participated in the study .\
RESULTS	During the PF session , the rescuers performed CPR with higher compression rates ( 156.8 vs 101.6 cpm ) , more compressions ( 787.2 vs 510.8 per 5 minutes ) , and more duty cycles ( 51.0 % vs 41.7 % ) , but a lower percentage of effective compressions ( 47.7 % vs 57.9 % ) and a lower compression depth ( 35.6 vs 38.0 mm ) than they did during the 100-cpm session .\
RESULTS	The CPR quality deteriorated in numbers and percentile of effective compression since the third minute in the PF session and the fourth minute in the 100-cpm session .\
RESULTS	The percentile of compressions with adequate depth in the 100-cpm sessions was higher than that in the PF sessions during the second , third , and fourth minutes of CPR .\
CONCLUSIONS	Push-fast technique showed a significant decrease in the percentile of effective chest compression compared with the 100-cpm technique during the 5-minute hand-only CPR .\
CONCLUSIONS	The PF technique exhibited a trend toward increased fatigue in the rescuers , which can result in early decay of CPR quality .\
\
###23273846\
BACKGROUND	Robot-assisted radical cystectomy ( RARC ) is increasingly being used in the management of bladder cancer .\
BACKGROUND	Studies comparing RARC and open radical cystectomy ( ORC ) have reported conflicting results .\
BACKGROUND	We conducted a systematic review and meta-analysis of the literature on the efficacy and advantages of RARC compared with ORC .\
METHODS	An electronic database search of PubMed , Scopus , and the Cochrane Library was performed up to July 8 , 2012 .\
METHODS	This systematic review and meta-analysis was performed based on all randomized controlled trials ( RCTs ) and observational comparative studies assessing the two techniques .\
RESULTS	One RCT , eight studies with prospectively collected data , and four retrospective studies were identified , including 962 cases .\
RESULTS	Although RARC was associated with longer operative time ( p < 0.001 ) , patients in this group might benefit from less overall perioperative complications ( p = 0.04 ) , more lymph node yield ( p = 0.009 ) , less estimated blood loss ( p < 0.001 ) , a lower need for perioperative transfusion ( p < 0.001 ) , and shorter length of hospital stay ( p < 0.001 ) .\
RESULTS	Positive surgical margins did not differ significantly between techniques .\
RESULTS	Sensitivity analysis with prospective studies showed similar results to the original analysis , but no significant difference of lymph node yield and length of stay between two techniques .\
CONCLUSIONS	RARC is a mini-invasive alternative to ORC with less overall perioperative complications , more lymph node yields , less estimated blood loss , less need for a perioperative transfusion , and shorter length of stay .\
\
###17387168\
OBJECTIVE	Premature infants with chronic lung disease benefit from comprehensive care , which typically is based in tertiary medical centers .\
OBJECTIVE	When such centers are not easily accessible , alternative models of care are needed .\
OBJECTIVE	The purpose of this work was to compare community-based follow-up , provided via telephone contacts , to traditional center-based follow-up of premature infants with chronic lung disease .\
METHODS	After discharge from neonatal intensive care , 150 premature infants with chronic lung disease were randomly assigned to either community-based ( n = 75 ) or center-based ( n = 75 ) follow-up .\
METHODS	In community-based follow-up , a nurse specialist maintained telephone contact with the infant 's primary caregiver and health care providers .\
METHODS	Center-based follow-up consisted of visits to a medical center-based multidisciplinary clinic staffed by a neonatologist , a nurse specialist , and a social worker .\
METHODS	The outcomes of interest were Bayley Scales of Infant Development mental developmental index and psychomotor developmental index , Vineland Adaptive Behavioral Composite , and growth delay ( weight for length < 5th percentile ) at 1-year adjusted age and respiratory rehospitalizations through 1-year adjusted age .\
RESULTS	In each randomization group , 73 infants survived , and 69 were evaluated at 1-year adjusted age .\
RESULTS	The median mental development index ( corrected for gestational age ) was 90 for both groups .\
RESULTS	The median psychomotor developmental index was 82 for the center-based group and 81 for the community-based group .\
RESULTS	The median Vineland Adaptive Behavioral Composite was 100 and 102 for the center-based and community-based groups , respectively .\
RESULTS	In the center-based and community-based groups , respectively , the proportions with growth delay were 13 % and 26 % , and the proportions rehospitalized for respiratory illness were 33 % and 29 % .\
CONCLUSIONS	Infants randomly assigned to community-based , as compared with those randomly assigned to center-based follow-up , had similar developmental and health outcomes .\
CONCLUSIONS	The former approach might be a preferred alternative for families in rural settings or families for whom access to a tertiary care medical center is difficult .\
\
###14984396\
OBJECTIVE	We have tested the relapse-preventive effect of citalopram when compared with placebo in 282 patients with Seasonal Affective Disorder ( SAD ) responding to 1 week of light therapy .\
METHODS	The response rate to 1-week light therapy and relapse during the continuation phase of 15 weeks were assessed by use of the Hamilton Depression Rating Scale ( HAM-D17 ) , the six-item subscale ( HAM-D6 ) , the Melancholia Scale ( MES ) , and the combined HAM-D/SIGH-SAD .\
RESULTS	The response rate to light therapy was 62.5 % on the HAM-D17 and the HAM-D6 , 56.1 % on the HAM-D/SIGH-SAD , 52.8 % on the MES .\
RESULTS	In the continuation phase , citalopram was found superior to placebo on all scales , but the difference was only of statistical significance on the HAM-D6 and the MES .\
RESULTS	Mean citalopram dose was 26.3 mg .\
CONCLUSIONS	Light therapy was found to have and early onset of action .\
CONCLUSIONS	On the HAM-D6 and the MES citalopram significantly reduced the relapse rate in the continuation phase .\
\
###22428572\
BACKGROUND	The negative outcomes associated with painful and damaged nipples have been widely documented in the breastfeeding literature .\
BACKGROUND	Numerous studies have been conducted evaluating topical preparations to treat nipple pain and damage with equivocal findings .\
BACKGROUND	No studies have evaluated the effectiveness of the increasingly popular all-purpose nipple ointment ( APNO ) .\
BACKGROUND	The purpose of this trial is to evaluate the effect of the APNO versus lanolin on nipple pain among breastfeeding women with damaged nipples .\
METHODS	A double-blind , randomized controlled trial was conducted in a large single-site , tertiary-care hospital in Toronto , ON , Canada .\
METHODS	Breastfeeding women ( n = 151 ) identified as having damage to one or both nipples were randomized to apply either APNO ( intervention group ) or lanolin ( control group ) to their nipples according to the trial protocol .\
METHODS	The primary outcome was nipple pain at 1 week after randomization measured using the Short Form McGill Pain Questionnaire .\
METHODS	Additional outcomes at 1 week after randomization and 12 weeks postpartum included nipple yeast symptoms and/or mastitis , rates of breastfeeding duration and exclusivity , and maternal satisfaction with infant feeding method and treatment ointment .\
RESULTS	There were no significant group differences in mean pain scores at 1 week after randomization .\
RESULTS	Women in the lanolin group reported significantly greater satisfaction with their infant feeding method and had nonsignificantly higher breastfeeding duration and exclusivity rates at 12 weeks postpartum .\
CONCLUSIONS	Results suggest that APNO is not superior to lanolin in treating painful , damaged nipples .\
\
###21360490\
OBJECTIVE	To assess the efficacy and safety of tocilizumab plus methotrexate ( MTX ) versus MTX alone in preventing structural joint damage and improving physical function and disease activity in patients with moderate-to-severe rheumatoid arthritis and inadequate responses to MTX .\
METHODS	A total of 1,196 patients were enrolled in a 2-year , randomized , double-blind , placebo-controlled trial .\
METHODS	Patients received tocilizumab ( 8 mg/kg or 4 mg/kg ) or placebo every 4 weeks plus MTX .\
METHODS	Rescue treatment was available from week 16 .\
METHODS	Results from year 1 are presented .\
RESULTS	Mean change in the total Genant-modified Sharp score was 0.29 and 0.34 with tocilizumab 8 mg/kg plus MTX and 4 mg/kg plus MTX , respectively , versus 1.13 with placebo plus MTX ( P < 0.0001 for both comparisons ) .\
RESULTS	Analysis of variance of the area under the curve for change from baseline in the disability index of the Health Assessment Questionnaire showed greater decreases with tocilizumab 8 mg/kg and 4 mg/kg ( -144.1 and -128.4 units , respectively ) than with placebo ( -58.1 units ; P < 0.0001 for both comparisons ) .\
RESULTS	Proportions of patients with American College of Rheumatology 20 % , 50 % , and 70 % improvement and with Disease Activity Score in 28 joints remission were higher in those receiving 8 mg/kg tocilizumab than in those receiving placebo ( P < 0.0001 for all comparisons ) .\
RESULTS	The safety profile of tocilizumab was consistent with the profiles in previous studies .\
RESULTS	Infections were the most common adverse and serious adverse events .\
CONCLUSIONS	The findings of this study show that tocilizumab plus MTX results in greater inhibition of joint damage and improvement in physical function than does MTX alone .\
CONCLUSIONS	Tocilizumab has a well-characterized safety profile .\
\
###25286026\
OBJECTIVE	The purpose of this study was to evaluate the efficacy of once-daily guanfacine extended release ( GXR ) monotherapy administered either in the morning or evening , using a modified Conners ' Parent Rating Scale-Revised : Short Form ( CPRS-R : S ) assessed three times/day in children with attention-deficit/hyperactivity disorder ( ADHD ) .\
METHODS	This multicenter , double-blind , placebo-controlled study randomized children 6-12 years of age with ADHD into three groups : GXR a.m. ( GXR in the morning and placebo in the evening ) , GXR p.m. ( placebo in the morning and GXR in the evening ) , or twice-daily placebo .\
METHODS	The CPRS-R : S , administered in the morning , afternoon , and evening prior to each study visit , was a secondary measure of efficacy .\
RESULTS	A total of 333 subjects were included in the analysis population ( GXR a.m. , n = 107 ; GXR p.m. , n = 114 ; placebo , n = 112 ) .\
RESULTS	At visit 10 , last observation carried forward ( LOCF ) , subjects receiving GXR demonstrated significantly greater improvement from baseline in the daily mean CPRS-R : S total score , as well as in each of the morning , afternoon , and evening CPRS-R : S assessments , compared with placebo , regardless of the time of GXR administration ( p < 0.001 vs. placebo for GXR a.m. and GXR p.m. ) .\
RESULTS	In addition , subjects receiving GXR showed significantly greater improvements from baseline in each subscale score ( oppositional , cognitive problems/inattention , hyperactivity , and ADHD index ) compared with those receiving placebo , regardless of time of administration ( p < 0.003 vs. placebo across all subscales for GXR a.m. and GXR p.m. ) .\
CONCLUSIONS	These results provide further support for the demonstrated efficacy of once-daily GXR in reducing ADHD symptoms , and demonstrate that response is consistent throughout the day regardless of the time of administration , with improvement seen in ratings of oppositional as well as of ADHD symptoms .\
\
###24974817\
OBJECTIVE	To determine whether genotypes at 2 major loci associated with late age-related macular degeneration ( AMD ) , complement factor H ( CFH ) and age-related maculopathy susceptibility 2 ( ARMS2 ) , influence the relative benefits of Age-Related Eye Disease Study ( AREDS ) supplements .\
METHODS	Unplanned retrospective evaluation of a prospective , randomized , placebo-controlled clinical trial of vitamins and minerals for the treatment of AMD .\
METHODS	AREDS participants ( mean age , 69 years ) who were at risk of developing late AMD and who were randomized to the 4 arms of AREDS supplement treatment .\
METHODS	Analyses were performed using the Cox proportional hazards model to predict progression to late AMD ( neovascular or central geographic atrophy ) .\
METHODS	Statistical models , adjusted for age , gender , smoking status , and baseline AMD severity , were used to examine the influence of genotypes on the response to therapy with 4 randomly assigned arms of AREDS supplement components : placebo , antioxidants ( vitamin C , vitamin E , - carotene ) , zinc , or a combination .\
METHODS	The influence of the genotype on the relative treatment response to the randomized components of the AREDS supplement , measured as progression to late AMD .\
RESULTS	Of the 1237 genotyped AREDS participants of white ethnicity , late AMD developed in 385 ( 31.1 % ) during the mean follow-up of 6.6 years .\
RESULTS	As previously demonstrated , CFH genotype ( P = 0.005 ) , ARMS2 ( P < 0.0001 ) , and supplement were associated individually with progression to late AMD .\
RESULTS	An interaction analysis found no evidence that the relative benefits of AREDS supplementation varied by genotype .\
RESULTS	Analysis of ( 1 ) CFH rs1061170 and rs1410996 combined with ARMS2 rs10490924 with the 4 randomly assigned arms of AREDS supplement and ( 2 ) analysis of the combination of CFH rs412852 and rs3766405 with ARMS2 c. 372_815del443ins54 with the AREDS components resulted in no interaction ( P = 0.06 and P = 0.45 , respectively , before multiplicity adjustment ) .\
CONCLUSIONS	The AREDS supplements reduced the rate of AMD progression across all genotype groups .\
CONCLUSIONS	Furthermore , the genotypes at the CFH and ARMS2 loci did not statistically significantly alter the benefits of AREDS supplements .\
CONCLUSIONS	Genetic testing remains a valuable research tool , but these analyses suggest it provides no benefits in managing nutritional supplementation for patients at risk of late AMD .\
\
###9431617\
METHODS	A prospective randomized clinical study .\
OBJECTIVE	To evaluate supplementary pedicle screw fixation ( Cotrel-Dubousset ) in posterolateral lumbar spinal fusion .\
BACKGROUND	The rationale behind lumbar fusion is to eliminate pathologic motion to relieve pain .\
BACKGROUND	To improve fusion rates and to allow reduction , a rigid transpedicular screw fixation may be beneficial , but the positive effect of this may be counter-balanced by an increase in complications .\
METHODS	The inclusion criteria were severe , chronic low back pain from spondylolisthesis Grades 1 and 2 or from primary or secondary degenerative segmental instability .\
METHODS	One hundred thirty patients were randomly allocated to receive no instrumentation ( n = 66 ) or Cotrel-Dubousset instrumentation ( n = 64 ) in posterolateral lumbar fusion .\
METHODS	Variables were registered at the time of surgery and at 1 and 2 years after surgery .\
RESULTS	Follow-up was achieved in 97.7 % of the patients .\
RESULTS	Fusion rates deduced from plain radiographs were not significantly different between instrumented and noninstrumented groups .\
RESULTS	The functional outcome assessed by the Dallas Pain Questionnaire improved significantly in both groups , and there were no significant differences in results between the two groups , except for significantly better ( P < 0.06 ) functional outcome in relation to daily activities in the instrumented group when neural decompression had been performed .\
RESULTS	The global patients ' satisfaction was 82 % in the instrumented group versus 74 % in the noninstrumented group ( not significant ) .\
RESULTS	Fixation of instrumentation increased operation time , blood loss , and early reoperation rate significantly .\
RESULTS	Patients experienced only a few minor postoperative complications ; none were major .\
RESULTS	Two infections appeared in the Cotrel-Dubousset group .\
RESULTS	Significant symptoms from misplacement of pedicle screws were seen in 4.8 % of the instrumented patients .\
CONCLUSIONS	Lumbar posterolateral fusion with pedicle screw fixation increases the operation time , blood loss , and reoperation rate , and leads to a significant risk of nerve injury .\
CONCLUSIONS	The functional outcome improves significantly with high patient satisfaction , with or without instrumentation .\
CONCLUSIONS	No significant differences were observed between the two groups in functional outcome and fusion rate .\
CONCLUSIONS	The only gain in functional outcome from instrumentation was found in the daily activity category in patients with supplementary neural decompression .\
CONCLUSIONS	The results of this study do not justify the general use of pedicle screw fixation alone as an adjunct to posterolateral lumbar fusion .\
\
###12590622\
BACKGROUND	The purpose of this study was to compare the effectiveness of habit reversal with a placebo control as a treatment for chronic nail biting in adults .\
METHODS	Thirty adults with a chronic nail-biting problem ( occurring > or = 5 times/day nearly every day for > or = 4 weeks and causing physical damage or social impairment ) were randomly assigned to a placebo control or habit reversal group .\
METHODS	Five participants withdrew from the study prior to the completion of treatment .\
METHODS	The remaining individuals in both groups received a total of 2 hours of treatment over 3 sessions .\
METHODS	Individuals in the habit reversal group ( N = 13 ) received the components of awareness training , competing response training , and social support .\
METHODS	Individuals in the placebo control group ( N = 12 ) simply discussed their nail biting .\
METHODS	At pretreatment , posttreatment , and a 5-month follow-up , nail length was measured , photographs were taken of the damaged nails and later rated by independent observers , and data on participant depression , anxiety , and self-esteem were obtained .\
METHODS	Treatment compliance and acceptability data were collected at posttreatment only .\
RESULTS	Results showed that habit reversal produced a greater increase in nail length at posttreatment and follow-up when compared with the placebo .\
RESULTS	Data from the independent raters confirmed these findings .\
RESULTS	Habit reversal was also viewed as a more acceptable intervention by the participants .\
RESULTS	At posttreatment , the habit reversal group had increased their nail length by 22 % from pretreatment compared with a 3 % increase for the placebo group .\
RESULTS	At follow-up , the habit reversal group maintained a 19 % increase in nail length from pretreatment compared with a 0 % increase for the placebo group .\
CONCLUSIONS	Findings from this study suggest habit reversal is more effective than a placebo control and should be considered a well-established intervention for body-focused repetitive behaviors .\
\
###26436208\
BACKGROUND	Remote ischemic preconditioning ( RIPC ) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery , but uncertainty about clinical outcomes remains .\
METHODS	We conducted a prospective , double-blind , multicenter , randomized , controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass under total anesthesia with intravenous propofol .\
METHODS	The trial compared upper-limb RIPC with a sham intervention .\
METHODS	The primary end point was a composite of death , myocardial infarction , stroke , or acute renal failure up to the time of hospital discharge .\
METHODS	Secondary end points included the occurrence of any individual component of the primary end point by day 90 .\
RESULTS	A total of 1403 patients underwent randomization .\
RESULTS	The full analysis set comprised 1385 patients ( 692 in the RIPC group and 693 in the sham-RIPC group ) .\
RESULTS	There was no significant between-group difference in the rate of the composite primary end point ( 99 patients [ 14.3 % ] in the RIPC group and 101 [ 14.6 % ] in the sham-RIPC group , P = 0.89 ) or of any of the individual components : death ( 9 patients [ 1.3 % ] and 4 [ 0.6 % ] , respectively ; P = 0.21 ) , myocardial infarction ( 47 [ 6.8 % ] and 63 [ 9.1 % ] , P = 0.12 ) , stroke ( 14 [ 2.0 % ] and 15 [ 2.2 % ] , P = 0.79 ) , and acute renal failure ( 42 [ 6.1 % ] and 35 [ 5.1 % ] , P = 0.45 ) .\
RESULTS	The results were similar in the per-protocol analysis .\
RESULTS	No treatment effect was found in any subgroup analysis .\
RESULTS	No significant differences between the RIPC group and the sham-RIPC group were seen in the level of troponin release , the duration of mechanical ventilation , the length of stay in the intensive care unit or the hospital , new onset of atrial fibrillation , and the incidence of postoperative delirium .\
RESULTS	No RIPC-related adverse events were observed .\
CONCLUSIONS	Upper-limb RIPC performed while patients were under propofol-induced anesthesia did not show a relevant benefit among patients undergoing elective cardiac surgery .\
CONCLUSIONS	( Funded by the German Research Foundation ; RIPHeart ClinicalTrials.gov number , NCT01067703 . )\
\
###8256213\
BACKGROUND	Levothyroxine has often been given to patients operated on for nodular goiter to prevent recurrence .\
BACKGROUND	The rationale is that suppression of thyroid-stimulating hormone ( TSH ) , considered to be the main growth factor in this disease , can be obtained by administration of levothyroxine .\
METHODS	Sixty patients undergoing operation for nontoxic nodular goiter were randomized in two groups : ( 1 ) thirty-two were administered levothyroxine at substitutive dosage ( 100 micrograms ) or placebo and ( 2 ) twenty-eight were given levothyroxine at suppressive dosage ( 2.2 to 3 micrograms/kg/day ) .\
METHODS	Levels of thyroid hormones and TSH were evaluated every 6 months .\
METHODS	Recurrences detected by echography were then considered .\
RESULTS	After a 3-year follow-up we observed 25 of 32 recurrences in group 1 and 6 of 28 in group 2 ( p < 0.005 ) .\
RESULTS	Subjects with endemic goiter problems responded better to therapy .\
RESULTS	Patients with a multinodular goiter responded better than patients with a uninodular goiter .\
RESULTS	No difference was found regarding the type of surgical treatment ( subtotal thyroidectomy vs lobectomy ) .\
CONCLUSIONS	The results confirmed suppressive therapy as actually being effective in preventing recurrences at least in iodine-deficient regions like Italy .\
CONCLUSIONS	Thus for these patients it may be suggested as a prophylactic treatment after operation .\
\
###24797544\
OBJECTIVE	To assess the use of a hydrogel ocular bandage ( HOB ) on clear corneal incisions in phacoemulsification cataract surgery and determine whether HOB reduces ocular surface contaminants ingress after routine surgery .\
METHODS	In this prospective randomized controlled study , thirty eyes of patients undergoing uneventful phacoemulsification were recruited consecutively and randomly assigned to have a HOB applied to the corneal incision at the end of the surgery or not .\
METHODS	At the end of the surgery , trypan blue ( TRB ) was instilled on the ocular surface , aqueous fluid was aspirated from the anterior chamber ( AC ) and its optical density was measured using ultraviolet spectrophotometry .\
METHODS	The corneal incisions were examined postoperatively using anterior segment optical coherence tomography .\
METHODS	Main outcome measures were concentration of TRB in the AC , corneal incision architecture , intraocular pressure ( IOP ) and Seidel test .\
RESULTS	All incisions were Seidel negative .\
RESULTS	The mean IOP in the immediate postoperative period was 18.1 5.48 mmHg for the intervention group and 16.9 5.7 mmHg for the control group ( p > 0.05 ) .\
RESULTS	No architectural differences of the incisions between the two groups were noted .\
RESULTS	The total mean length of the three-step corneal incisions in the two groups was 2261.2 96.92 m and 2263 119.75 m , respectively ( p > 0.05 ) .\
RESULTS	No trace of TRB was detected in any of the samples .\
CONCLUSIONS	Proper surgical wound construction without the use of a HOB is efficient in preventing the ingress of fluid through the main corneal incision postoperatively .\
\
###19014838\
BACKGROUND	Clarithromycin extended-release tablets are indicated for the treatment of adults with acute maxillary sinusitis caused by Haemophilus influenzae , Moraxella catarrhalis , or Streptococcus pneumoniae ; acute bacterial exacerbation of chronic bronchitis due to H influenzae , Haemophilus parainfluenzae , M catarrhalis , or S pneumoniae ; or community acquired pneumonia due to H influenzae , H parainfluenzae , M catarrhalis , S pneumoniae , Chlamydia pneumoniae , or Mycoplasma pneumoniae .\
OBJECTIVE	This study was conducted to assess the bioequivalence of test and reference formulations of clarithromycin extended-release 500-mg tablets under fasting and fed conditions .\
METHODS	This was a single-dose , randomized , open-label , 2-period , 2-way crossover study with a 1-week washout period between doses .\
METHODS	Separate bioequivalence studies ( fasting and fed ) were performed in 2 groups of healthy male Jordanian volunteers .\
METHODS	Eighteen blood samples were obtained from each volunteer over 38 hours after drug administration .\
METHODS	Clarithromycin concentrations were determined in plasma using a validated high-performance liquid chromatography method with electrochemical detection .\
METHODS	Pharmacokinetic parameters of clarithromycin ( C ( max ) , T ( max ) , AUC ( 0-t ) , AUC ( 0-infinity ) , lambda ( z ) [ first-order elimination rate constant ] , and t ( ( 1/2 ) ) ) were calculated and analyzed statistically .\
METHODS	Tolerability was assessed based on changes in vital signs and laboratory tests , and by questioning subjects about adverse events .\
RESULTS	Thirty-eight volunteers each participated in the fasting and fed studies .\
RESULTS	The mean ages of participants in the fasting and fed studies were 26.7 and 27.6 years , respectively ; their mean weight was 71.2 and 70.9 kg and mean height was 171.3 and 179.0 cm .\
RESULTS	Under fasting conditions , the arithmetic mean ( SD ) C ( max ) was 569.4 ( 189.3 ) ng/mL for the test formulation and 641.2 ( 202.0 ) ng/mL for the reference formulation , with a geometric mean ratio of 0.88 .\
RESULTS	The arithmetic mean AUC ( 0-t ) was 8602.9 ( 4105.1 ) and 8245.3 ( 4122.4 ) ng .\
RESULTS	h/mL in the respective formulations , with a geometric mean ratio of 1.06 .\
RESULTS	The arithmetic mean T ( max ) was 8.0 ( 5.6 ) and 6.1 ( 3.8 ) hours .\
RESULTS	In the fed study , the C ( max ) and AUC of both formulations were significantly increased relative to the fasting study ( P < 0.05 ) .\
RESULTS	The arithmetic mean C ( max ) of the 2 formulations was 1183.0 ( 637.5 ) and 1199.6 ( 496.3 ) ng/mL , with a geometric mean ratio of 0.93 .\
RESULTS	The arithmetic mean AUC ( 0-t ) was 12,981.2 ( 7849.0 ) and 11,822.9 ( 5790.2 ) ng .\
RESULTS	h/mL , with a geometric mean ratio of 1.06 .\
RESULTS	The arithmetic mean T ( max ) was 5.7 ( 2.8 ) and 6.7 ( 2.5 ) hours .\
RESULTS	The 90 % CI for the ratio ( test : reference ) of log-transformed C ( max ) and AUC values was within the acceptance range of 0.80 to 1.25 .\
RESULTS	The 2 formulations were both well tolerated , and no adverse events were reported during the study .\
CONCLUSIONS	In these fasting and fed studies in healthy male Jordanian volunteers , the 2 formulations of clarithromycin extended-release 500-mg tablets were found to be bioequivalent according to the US Food and Drug Administration regulatory definition .\
CONCLUSIONS	Administration with food significantly increased the rate and extent of absorption of both products , with no significant effect on their bioequivalence .\
\
###25332469\
BACKGROUND	Calcium inhibits and ascorbic acid ( AA ) enhances iron absorption from iron-fortified foods .\
BACKGROUND	Absorption efficiency depends on iron status , although the interaction is unclear .\
OBJECTIVE	We investigated the ability of AA to overcome calcium-induced inhibition of iron absorption in children differing in iron status .\
METHODS	The effect of calcium ( 0 , 100 , and 200 mg/test meal ) on iron absorption in the absence and presence of AA ( 0 , 42.5 , and 85 mg/test meal ) from a casein/whey-based drink fortified with ferrous sulfate was assessed in a series of randomized crossover studies both in iron-replete ( IR ) Indian schoolchildren and in children with iron deficiency anemia ( IDA ) ( 6-11 y ; n = 14-16 / group ) by using stable isotopes .\
RESULTS	In the absence of calcium and AA , iron absorption from the casein/whey-based drink was 20 % lower in IR children than in children with IDA .\
RESULTS	The addition of calcium reduced mean iron absorption by 18-27 % , with the effect being stronger for high added calcium ( P < 0.01 ) .\
RESULTS	AA at a 2:1 or 4:1 molar ratio enhanced iron absorption by a factor of 2-4 and greatly overcompensated for the inhibitory effect of calcium on iron absorption in a dose-dependent manner ( P < 0.001 ) .\
RESULTS	The dose-response effect tended to be stronger ( P < 0.1 ) in the IDA group , and iron status was of far less influence on iron absorption than the enhancing effect of AA .\
CONCLUSIONS	When adding AA to iron-fortified milk products , care should be taken not to provide absorbable iron in excess of needs .\
\
###12656706\
OBJECTIVE	To study the contribution of therapist-initiated telephone contact in the treatment of recurrent headache via the Internet .\
BACKGROUND	Internet-based cognitive behavioral self-help is a promising new venue for the treatment of recurrent headache .\
BACKGROUND	While cost-effective , there are indications that this modality may be associated with high dropout rates .\
METHODS	The role of therapist-initiated contact was investigated in a randomized controlled trial in which 44 self-recruited headache sufferers were randomized to either a Web-based self-help program with e-mail support or to a group receiving , in addition , weekly individual telephone calls .\
METHODS	An additional 8 control subjects were recruited to receive similar treatment outside of the study .\
RESULTS	Dropout rates were 29 % in the telephone support group and 35 % in the control group , suggesting that the telephone calls did not affect dropout .\
RESULTS	Results showed significant reductions in headache-related disability , depression , maladaptive coping strategies , and perceived stress but little to indicate any superior performance in the Internet-only group and little improvement in the headache index .\
RESULTS	In short , therapist-initiated telephone calls did not influence the results .\
CONCLUSIONS	Internet-based treatment for headache is not affected by minimal therapist-initiated telephone contact .\
\
###9579238\
OBJECTIVE	The effect of food ingestion on the gastrointestinal absorption and antidiuretic action of oral desmopressin .\
OBJECTIVE	An oral preparation of desmopressin , a synthetic analogue of vasopressin , has recently become available for clinical use .\
METHODS	A randomized , single-blind , crossover study with four treatment arms .\
METHODS	Day A , no meal + placebo ; B , no meal + 400 micrograms oral desmopressin ; C , standard meal + 400 micrograms oral desmopressin ; D , standard meal + 400 micrograms oral desmopressin after 1.5 hours .\
METHODS	Plasma desmopressin was measured every 15-30 minutes for 6 hours after drug intake .\
METHODS	An intravenous hydration regimen was employed on each study day .\
METHODS	Sixteen healthy , non-smoking , mean aged 20-35 years ( mean 27.8 years ) .\
METHODS	Plasma desmopressin concentrations were measured throughout each study day to calculate the area under the desmopressin plasma-concentration-time curve to infinity ( AUCinf ) , the maximum plasma desmopressin concentration ( Cmax ) , the time at which Cmax was reached ( Tmax ) and the time at which plasma desmopressin was first detected ( Tlag ) .\
METHODS	Urine volume , urine osmolality and plasma sodium concentrations were also measured at specified times on each study day .\
RESULTS	The total absorption of oral desmopressin , reflected by the AUCinf , was significantly higher when taken during the fasting state ( day B ) compared with its administration with or 1.5 hours after a standard meal ( days C and D ) .\
RESULTS	In addition , Cmax was higher and both Tmax and Tlag were shorter on day B compared with days C and D. No effect of food ingestion was observed on the pharmacodynamics of oral desmopressin : urine volume was decreased and urine osmolality was increased to similar extents on all active treatment days ( B , C and D ) .\
RESULTS	No significant reductions in plasma sodium concentrations ( a safety parameter ) was observed during the trial .\
CONCLUSIONS	The gastrointestinal absorption of desmopressin is reduced and delayed if administered with or 1.5 hours after a meal .\
CONCLUSIONS	This decreased absorption of desmopressin did not have an impact on the antidiuretic action of the drug since all treatment regimens elicted a maximal response .\
CONCLUSIONS	It is possible that administration of desmopressin in the fasting state may prolong its duration of action .\
\
###24045669\
BACKGROUND	This study aimed to determine whether combination S-1 plus cisplatin ( CDDP ) therapy , the most widely used therapy for Japanese patients with advanced gastric cancer , and the novel oral antiangiogenic agent TSU-68 could contribute to gastric cancer treatment .\
METHODS	Ninety-three patients with chemotherapy-nave unresectable or recurrent advanced gastric cancers were randomised into two groups : TSU-68 plus S-1 / CDDP ( group A ) and S-1 / CDDP ( group B ) groups .\
METHODS	Both patient groups received identical S-1 and CDDP dosages .\
METHODS	TSU-68 was orally administered for 35 consecutive days .\
METHODS	Group B patients received S-1 orally twice daily for three consecutive weeks , followed by intravenous CDDP on day 8 .\
METHODS	The primary endpoint was progression-free survival ( PFS ) .\
RESULTS	Median PFS periods were 208 and 213 days in groups A and B , respectively ( P = 0.427 ) .\
RESULTS	Median survival periods for groups A and B were 497.0 and 463.5 days , respectively ( P = 0.219 ) .\
RESULTS	No statistically significant differences were noted for PFS , survival or the adverse event ( AE ) incidence rate .\
RESULTS	All AEs were expected according to previous reports for TSU-68 , TS-1 , and CDDP .\
CONCLUSIONS	Combination therapy involving TSU-68 , S-1 , and CDDP was safe and well tolerated in patients with chemotherapy-nave unresectable or recurrent advanced gastric cancers .\
CONCLUSIONS	However , factors related to therapeutic efficacy should be investigated further .\
\
###17584432\
OBJECTIVE	To determine whether the Roper , Logan and Tierney Model of nursing care affects the outcomes of patients with chronic obstructive pulmonary disease .\
BACKGROUND	Chronic obstructive pulmonary disease is a leading chronic health problem throughout the world .\
BACKGROUND	Although there are numerous studies on patients with chronic obstructive pulmonary disease , no studies have been found regarding patient care with chronic obstructive pulmonary disease investigated from the Roper , Logan and Tierney Model perspective .\
METHODS	The study design was an experimental style .\
METHODS	The sample consisted of 60 subjects with a diagnosis of chronic obstructive pulmonary disease who were hospitalized in a university hospital in Erzurum , Turkey , in 2001 and randomly selected into control and experimental groups .\
METHODS	On admission , the researcher completed a nursing diagnosis form for chronic obstructive pulmonary disease for each patient , consisting of demographic characteristics and an assessment nursing diagnosis for each of the patients .\
METHODS	Control group patients were treated by routine nursing care while the experimental group patients were treated by nursing care according to the Roper , Logan and Tierney Model .\
METHODS	Upon discharge , nursing diagnoses were assessed again in both control and experimental groups .\
METHODS	Results .\
METHODS	Although there was no statistically significant decrease in most nursing diagnoses in the control group , there was a statistically significant decrease in nursing diagnoses in favour of the experimental group .\
CONCLUSIONS	This study demonstrated that there were improvements in patient 's outcomes in the concept of holistic and individualized nursing care of patients with chronic obstructive pulmonary disease according to the Roper , Logan and Tierney model .\
CONCLUSIONS	The findings of this study have practical importance for nursing practise .\
CONCLUSIONS	Using the Roper , Logan and Tierney Model in care of patients with chronic obstructive pulmonary disease may serve as a guide for nurses working with chronic obstructive pulmonary disease patients to participate patient and her/his family to patient care and to facilitate the effectiveness of patient care .\
\
###17390738\
OBJECTIVE	Darbepoetin alfa has a longer half-life than epoetin - ( EPO ) alfa or beta , allowing administration at less frequent intervals for the treatment of renal anemia .\
OBJECTIVE	The aim of the present analysis was to evaluate the efficacy and tolerability of an every-2-week ( Q2W ) schedule of darbepoetin alfa in a large cohort of dialysis patients .\
METHODS	Data were combined from eight similarly designed 24-week phase 3b European studies , in which patients receiving EPO alfa or beta once-weekly were converted to Q2W darbepoetin alfa .\
METHODS	Darbepoetin alfa dosage was titrated to maintain hemoglobin ( Hb ) between 10 and 13 g/dl and efficacy was evaluated during a 4-week evaluation period .\
RESULTS	In the 1,101 patients assigned to Q2W darbepoetin alfa ( i.v. , n = 196 , s.c. , n = 905 ) , mean ( SD ) Hb levels were 11.53 ( 0.77 ) g/dl at baseline and 11.35 ( 1.04 ) g/dl at evaluation ( mean change in Hb -0.27 g/dl , 95 % confidence interval 0.34 , -0.20 ) .\
RESULTS	Hb levels were maintained between 10 and 13 g/dl during evaluation in 85 % of patients .\
RESULTS	Darbepoetin alfa doses were similar at baseline and evaluation , and the i.v. and s.c. routes were associated with similar efficacy and dose requirements .\
RESULTS	Darbepoetin alfa was well-tolerated .\
CONCLUSIONS	Q2W darbepoetin alfa is effective in maintaining Hb levels in dialysis patients switched from weekly rHuEPO , regardless of the route of administration and with no notable increase in the weekly equivalent dose .\
\
###15200652\
BACKGROUND	The aim of this study was to compare the effect of single-dose caudal ropivacaine , ropivacaine plus ketamine and ropivacaine plus tramadol in children for postoperative pain management .\
METHODS	Following ethics committee approval and informed parental consent , 99 ASA PS I or II children , between 1 and 10 years of age , scheduled for elective inguinal hernia repair with general anaesthesia , were recruited .\
METHODS	After induction of anaesthesia and placement of a laryngeal mask airway ( LMATM ) , the patients were randomly divided into three groups to receive either caudal ropivacaine alone ( 0.4 % , 2 mg x kg ( -1 ) ) in group R ( n = 32 ) or ropivacaine ( 0.2 % , 1 mg x kg ( -1 ) ) plus ketamine ( 0.25 mg x kg ( -1 ) ) in group RK ( n = 33 ) or ropivacaine ( 0.2 % , 1 mg x kg ( -1 ) ) plus tramadol ( 1 mg x kg ( -1 ) ) in group RT ( n = 34 ) with a total volume of 0.5 ml x kg ( -1 ) .\
METHODS	Systemic blood pressure ( SBP and DBP ) , heart rate ( HR ) , peripheral O2 saturation ( SpO2 ) , respiratory rate ( RR ) , sedation and pain scores were recorded at 5 , 10 , 15 and 30 min , 1 , 3 , 4 and 6 h following recovery from anaesthesia .\
METHODS	Pain was evaluated by Children 's Hospital of Eastern Ontario Pain Scale , and sedation with a five-point sedation test .\
RESULTS	No difference was found regarding age , weight and duration of operation between the groups ( P > 0.05 ) .\
RESULTS	No patient experienced hypotension , bradycardia or respiratory depression .\
RESULTS	Duration of analgesia was longer in group RT ( 1377 + / - 204 min ) than group R ( 1006 + / - 506 min ) ( P = 0.001 ) .\
RESULTS	In the tramadol group , fewer patients required supplementary analgesics in the first 24 h ( P = 0.005 ) .\
RESULTS	Sedation scores were below 2 in all groups .\
RESULTS	Incidence of postoperative nausea and vomiting was higher in group RT ( eight patients ) and group RK ( seven patients ) than group R ( one patient , P = 0.032 ) .\
CONCLUSIONS	Ropivacaine ( 0.4 % ) , ropivacaine ( 0.2 % ) plus ketamine ( 0.25 mg x kg ( -1 ) ) and ropivacaine ( 0.2 % ) plus tramadol ( 0.5 mg x kg ( -1 ) ) provided sufficient analgesia in children , but the duration of analgesia was longer in the RT group .\
\
###25586864\
OBJECTIVE	To evaluate skin irritation and patch adhesiveness of a new weekly low-dose levonorgestrel ( LNG ) and ethinyl estradiol ( EE ) contraceptive patch ( LNG/EE patch ) .\
METHODS	This analysis was part of an open-label , parallel-group , multicenter , phase 3 study that randomized healthy women to the LNG/EE patch ( one patch weekly for three consecutive weeks , followed by a patch-free week for 13 cycles ) or to an oral contraceptive for six cycles followed by seven LNG/EE patch cycles .\
METHODS	Participants selected patch application sites of abdomen , buttock or upper torso .\
METHODS	Investigators rated patch adhesiveness and skin irritation using standardized scales .\
METHODS	Participants rated skin irritation and itching daily using standardized scales and recorded patch fall-off on daily diary cards .\
RESULTS	A total of 32,508 patches were applied ( n = 1273 ) .\
RESULTS	At the five clinic visits in which investigators rated the patches , they rated adhesiveness = 0 ( no lift ) for 84 % of participants and skin irritation = absent/mild for 97 % of patches .\
RESULTS	Participants reported that 2-3 .7 % of patches fell off and rated skin irritation as absent or mild for 92 - 95 % of patches , according to site .\
CONCLUSIONS	Investigator - and participant-rated assessments of LNG/EE patch adhesiveness and irritation demonstrated a low incidence of patch detachment , skin irritation and pruritus .\
CONCLUSIONS	This secondary analysis of a phase 3 clinical trial of a new weekly low-dose LNG and EE contraceptive patch , which used assessment by both investigators and participants , observed a low incidence of skin irritation , pruritus and patch detachment .\
\
###25517389\
BACKGROUND	Although exercise training is known to promote post-exercise hypotension , there is currently no consistent argument about the effects of manipulating its various components ( intensity , duration , rest periods , types of exercise , training methods ) on the magnitude and duration of hypotensive response .\
OBJECTIVE	To compare the effect of continuous and interval exercises on hypotensive response magnitude and duration in hypertensive patients by using ambulatory blood pressure monitoring ( ABPM ) .\
METHODS	The sample consisted of 20 elderly hypertensives .\
METHODS	Each participant underwent three ABPM sessions : one control ABPM , without exercise ; one ABPM after continuous exercise ; and one ABPM after interval exercise .\
METHODS	Systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , heart rate ( HR ) and double product ( DP ) were monitored to check post-exercise hypotension and for comparison between each ABPM .\
RESULTS	ABPM after continuous exercise and after interval exercise showed post-exercise hypotension and a significant reduction ( p < 0.05 ) in SBP , DBP , MAP and DP for 20 hours as compared with control ABPM .\
RESULTS	Comparing ABPM after continuous and ABPM after interval exercise , a significant reduction ( p < 0.05 ) in SBP , DBP , MAP and DP was observed in the latter .\
CONCLUSIONS	Continuous and interval exercise trainings promote post-exercise hypotension with reduction in SBP , DBP , MAP and DP in the 20 hours following exercise .\
CONCLUSIONS	Interval exercise training causes greater post-exercise hypotension and lower cardiovascular overload as compared with continuous exercise .\
\
###22826137\
BACKGROUND	Prevention of vasospasm is a challenging issue in subarachnoid hemorrhage ( SAH ) patients and the objective is to compare high dobutamine-induced cardiac index ( CI ) and high norepinephrine-induced hypertension for the prevention of vasospasm in SAH patients .\
METHODS	Single center , single blind , controlled randomized study .\
METHODS	Patients hospitalized in intensive care unit ( ICU ) for a moderate to severe SAH ( WFNS grade 2 ) were randomized to receive dobutamine to reach a 25 % increase in cardiac index or norepinephrine to reach a mean arterial pressure 100 mmHg .\
METHODS	Norepinephrine could be used in the dobutamine group to maintain a cerebral pressure perfusion 60 mmHg .\
METHODS	Primary endpoint was the incidence of angiographic vasospasm in the first 14 days in the ICU setting , which was upheld by a cerebral arteriography .\
METHODS	Secondary endpoints were the incidence of delayed ischemic deficits , duration of mechanical ventilation , and ICU length of stay ( LOS ) .\
RESULTS	During the 3-year study , 41 patients were randomized .\
RESULTS	Six patients were excluded -- 3 because of consent withdrawal and 3 who did not receive the assigned treatment .\
RESULTS	Respectively , 17 and 18 patients in the dobutamine and the norepinephrine group were kept in analysis .\
RESULTS	Five ( 28 % ) patients in the dobutamine group and 5 ( 27 % ) patients in the norepinephrine group developed vasospasm in ICU ( p = 1 ) .\
RESULTS	Seven ( 41 % ) patients presented a delayed ischemic deficit in the dobutamine group and 9 ( 50 % ) in the norepinephrine group ( p = 0.24 ) .\
RESULTS	Duration of mechanical ventilation was 8 [ 0.5-11 .5 ] days in the dobutamine group and 19 [ 2.7-23 ] days in the norepinephrine group ( p = 0.01 ) .\
RESULTS	ICU LOS was 11 [ 6-15 ] days in the dobutamine group and 21 [ 9-28 ] days in the norepinephrine group ( p = 0.01 ) .\
CONCLUSIONS	As compared to norepinephrine-induced hypertension , dobutamine-induced high CI did not reduce the rate of vasospasm in SAH patients .\
CONCLUSIONS	Dobutamine may reduce durations of mechanical ventilation and ICU LOS .\
\
###12063480\
BACKGROUND	Botulinum toxin type A ( BTX-A ) is widely used for facial esthetics but is incompletely studied .\
OBJECTIVE	This study was conducted to evaluate the efficacy and safety of BTX-A treatment of glabellar lines .\
METHODS	Patients with moderate to severe glabellar lines at maximum frown received intramuscular injections of 20 U BTX-A ( BOTOX , Allergan , Inc , Irvine , Calif ) or placebo into 5 glabellar sites .\
METHODS	Patients were followed up for 120 days after injection .\
METHODS	Outcome measures were physician rating of glabellar line severity at maximum frown and rest , patient assessment of improvement , and vital sign and adverse event monitoring .\
RESULTS	Two hundred sixty-four patients were enrolled ( BTX-A : 203 , placebo : 61 ) .\
RESULTS	There was a significantly greater reduction in glabellar line severity with BTX-A than with placebo ( all measures , every follow-up visit ; P < .022 ) .\
RESULTS	The effect was maintained for many patients through day 120 .\
RESULTS	There was a low occurrence ( 5.4 % ) of mostly mild blepharoptosis in the BTX-A group .\
CONCLUSIONS	BTX-A injections are safe and effective in reducing the severity of glabellar lines .\
\
###17135993\
OBJECTIVE	To ascertain whether the differential responses that previously have been found between trauma-focused , cognitive-behavioral therapy ( TF-CBT ) , and child-centered therapy ( CCT ) for treating posttraumatic stress disorder ( PTSD ) and related problems in children who had been sexually abused would persist following treatment and to examine potential predictors of treatment outcome .\
METHODS	A total of 183 children 8 to 14 years old and their primary caregivers were assessed 6 and 12 months after their posttreatment evaluations .\
RESULTS	Mixed-model repeated analyses of covariance found that children treated with TF-CBT had significantly fewer symptoms of PTSD and described less shame than the children who had been treated with CCT at both 6 and 12 months .\
RESULTS	The caregivers who had been treated with TF-CBT also continued to report less severe abuse-specific distress during the follow-up period than those who had been treated with CCT .\
RESULTS	Multiple traumas and higher levels of depression at pretreatment were positively related to the total number of PTSD symptoms at posttreatment for children assigned to the CCT condition only .\
CONCLUSIONS	Children and caregivers assigned to TF-CBT continued to have fewer symptoms of PTSD , feelings of shame , and abuse-specific parental distress at 6 - and 12-month assessments as compared to participants assigned to CCT .\
\
###22939929\
OBJECTIVE	To describe neurodevelopmental outcomes in infants with single ventricle ( SV ) physiology and determine factors associated with worse outcomes .\
METHODS	Neurodevelopmental outcomes for infants with SV enrolled in a multicenter drug trial were assessed at 14 months of age using the Bayley Scales of Infant Development-II .\
METHODS	Multivariable regression analysis was used to identify factors associated with worse outcomes .\
RESULTS	Neurodevelopmental testing was performed at 14 1 months in 170/185 subjects in the trial .\
RESULTS	Hypoplastic left heart syndrome was present in 59 % and 75 % had undergone the Norwood operation .\
RESULTS	Mean Psychomotor Developmental Index ( PDI ) and mental developmental index ( MDI ) were 80 18 and 96 14 , respectively , ( normal 100 15 , P < .001 for each ) .\
RESULTS	Group-based trajectory analysis provided a 2-group model ( `` high '' and `` low '' ) for height z-score trajectory and brain type natriuretic peptide ( BNP ) trajectory .\
RESULTS	The predicted PDI scores were 15 points higher in the `` high '' height z-score trajectory compared with the `` low '' cluster ( P < .001 ) .\
RESULTS	A higher number of serious adverse events during the trial was associated with lower PDI scores ( P = .02 ) .\
RESULTS	The predicted MDI scores were 13-17 points lower in `` low height trajectory-high BNP trajectory '' group compared with the other 3 groups ( P < .001 ) .\
RESULTS	MDI scores were also lower in subjects who required extracorporeal membrane oxygenation during the neonatal hospitalization ( P = .01 ) or supplemental oxygen at discharge ( P = .01 ) .\
CONCLUSIONS	Neurodevelopmental outcome at 14 months of age is impaired in infants with SV physiology .\
CONCLUSIONS	Low height trajectory and high BNP trajectory were associated with worse neurodevelopmental outcomes .\
CONCLUSIONS	Efforts to improve nutritional status alone may not improve neurodevelopmental outcomes .\
\
###11467465\
OBJECTIVE	To compare pacemaker telemetry with simultaneous Holter recordings in the diagnosis of atrial fibrillation and to evaluate the STOP-AF study telemetry criteria for the presence of atrial fibrillation .\
RESULTS	18 consecutive patients enrolled in the STOP-AF study had simultaneous 24 h Holter recordings and down-loaded pacemaker telemetry .\
RESULTS	There was good agreement on heart rate , but the STOP-AF pacemaker criteria achieved only 57 % sensitivity with 64 % specificity for the presence of atrial fibrillation on Holter recording over 24 h. False-positives appeared to result from far-field sensing while false-negatives occurred with very short episodes of atrial fibrillation .\
RESULTS	The pacemaker 's antitachycardia responses were not specific for the presence of atrial fibrillation .\
CONCLUSIONS	Pacemaker telemetry is a potentially important source of data on cardiac arrhythmias .\
CONCLUSIONS	Further studies are required to define the limitations of these data in specific devices before they can be interpreted with confidence .\
\
###18594127\
BACKGROUND	Controversial findings exist in the literature with respect to the efficacy of visually guided weight-shifting ( WS ) training as a means of improving balance in healthy older adults .\
OBJECTIVE	The purpose of this study was to investigate the impact of two direction-specific , visually guided WS training protocols on standing balance of healthy elderly women .\
METHODS	Forty-eight community-dwelling elderly women , all free of any neurological or musculoskeletal impairment , were randomly assigned into : a group that practiced WS in the anterior/posterior direction ( A/P group , n = 19 ) , a group that practiced WS in the medio/lateral direction ( M/L group , n = 15 ) and a control group ( n = 14 ) .\
METHODS	Participants performed 12 training sessions of visually guided WS ( 3 sessions a week for 25 minutes per session ) .\
METHODS	Static balance was measured before and after training in normal ( bipedal ) quiet stance ( NQS ) and sharpened-Romberg stance ( SRS ) by recording center of pressure ( CoP ) variations and angular segment kinematics .\
RESULTS	In NQS , neither of the two training protocols had a significant impact on postural sway measures , although a significant decrease in interlimb asymmetry of CoP displacement was noted for the A/P group .\
RESULTS	In SRS , A/P training induced a significant reduction of CoP displacement , lower limb pitch and upper trunk roll rotation .\
CONCLUSIONS	The results of the study stress the importance of using direction-specific WS tasks in balance training , particularly in the A/P direction , in order to improve control of static balance in elderly women .\
\
###19079276\
OBJECTIVE	To estimate total energy intake and the energy gap-the daily imbalance between energy intake and expenditure-associated with discretionary behaviors of adolescents , namely their leisure active behaviors ( playing or participating in sports and heavy chores ) , leisure sedentary behaviors ( television ( TV ) viewing and playing video and computer games ) , productive sedentary behaviors ( reading or doing homework ) .\
METHODS	Prospective observational study .\
METHODS	A total of 538 students ( mean age at baseline = 11.7 years ) from public schools in the Boston area studied prospectively from the fall of 1995 to the spring of 1997 .\
METHODS	Anthropometric assessment including height and weight , dietary assessment using a youth food frequency questionnaire and measures of TV , video , reading/doing homework and youth physical activity .\
RESULTS	We estimate the change in total energy intake for each hour change in discretionary activity using regression methods .\
RESULTS	A 1-h increase in watching TV is associated with a 106 kcal h ( -1 ) increase in total energy intake ( 95 % confidence interval ( CI ) : 61-150 kcal day ( -1 ) ) .\
RESULTS	A similar change of 92 kcal h ( -1 ) ( 95 % CI : 37-147 kcal day ( -1 ) ) is seen with playing video and computer games .\
RESULTS	The change in energy intake associated with an hour change in physical activity is 292 kcal h ( -1 ) ( 95 % CI : 262-321 kcal day ( -1 ) ) .\
RESULTS	No significant change is associated with reading/doing homework .\
RESULTS	Assuming that typical energy expenditures are associated with these behaviors , reading/doing homework appears to be an ` energy neutral ' activity , whereas watching TV and playing video and computer games is associated with an energy surplus .\
RESULTS	If we assume that physical activity levels are moderate ( 3.5 METs ) , then this is also an energy surplus activity .\
RESULTS	If physical activity is assumed to be vigorous for the entire time allotted ( > 6.0 METs ) , an energy deficit could be achieved .\
RESULTS	We validated these estimates by calculating regressions predicting change in weight .\
RESULTS	Results indicate that each hour increase in TV viewing is associated with a weight increase of 0.38 kg ( 95 % CI : 0.17-0 .59 kg ) , with no significant associations for the other behaviors .\
RESULTS	A model with change in BMI as the dependent variable produced similar results .\
CONCLUSIONS	Watching TV is an activity associated with a daily energy surplus .\
CONCLUSIONS	Although physical activity is thought of as an energy deficit activity , our estimates do not support this hypothesis .\
CONCLUSIONS	Reading/doing homework is the only discretionary activity examined which appears to be clearly energy neutral .\
CONCLUSIONS	The differential impacts of these discretionary behaviors on energy intake and the energy gap are discussed in relation to food-related advertisements aimed at children and adolescents .\
\
###24509969\
BACKGROUND	Abdominal Cesarean sections ( C-sections ) are frequently associated with an increased risk of excessive or unpleasant scarring .\
BACKGROUND	A topical scar gel containing extract of Allium cepae , allantoin and heparin ( Contractubex ; Merz Pharmaceuticals GmbH , Germany ) , has shown efficacy in improving the appearance of various scar types .\
OBJECTIVE	To investigate the efficacy of the topical scar gel , Contractubex , in the early treatment of C-section scars .\
METHODS	A total of 61 females , aged 18 years , who had given birth by elective C-section for the first time within the last 5-10 days , were included in this prospective , randomized , single-center study .\
METHODS	Patients were advised to apply the topical scar gel twice daily ( treatment group ) , or received no treatment ( control group ) .\
METHODS	Efficacy was evaluated at 6 and 12 weeks after a baseline visit using the Patient and Observer Scar Assessment Scale ( POSAS ) , a validated scar assessment tool comprised of a Patient Scale and an Observer Scale .\
RESULTS	Analysis revealed a significant change in the POSAS Patient Scale total score , with a 14.2 % improvement in the treatment group compared with a decline of similar magnitude ( -14.8 % ) in the control group at week 6 .\
RESULTS	Significant improvements were also seen for POSAS Patient Scale sub-items in the treatment group compared with the control group for scar color ( 13.6 % vs -18.5 % , respectively , P = 0.0284 ) , stiffness ( 12.5 % vs -34.6 % , respectively , P = 0.0029 ) , and irregularity ( 29.4 % vs -46.2 % , respectively , P = 0.0140 ) after 6 weeks of treatment .\
RESULTS	No significant changes were observed for the POSAS Observer Scale total score or its subitems after treatment with the topical scar gel , although there was a strong overall trend in favor of the treatment group .\
RESULTS	No significant adverse events were observed during the study .\
CONCLUSIONS	Contractubex represents an efficacious and well-tolerated preventative treatment that rapidly and significantly improves the color , stiffness and irregularity of C-section scars .\
\
###22143911\
OBJECTIVE	To determine sirolimus steady-state pharmacokinetics , and to assess the relationship between time-normalized trough sirolimus concentration ( C ( min , TN ) ) and evidence of efficacy ( rejection and death ) and adverse reactions ( stomatitis and pneumonia ) in liver allograft patients .\
METHODS	Dense sampling of sirolimus was performed over a single daily-dosing interval in 11 hepatic allograft recipients on day 28 and at 3 months after start of treatment .\
METHODS	Serial trough concentration sampling was performed in 380 hepatic allograft recipients on days 1 , 7 , 14 , 28 , 42 , 60 , 90 , 180 , 270 and 360 after start of treatment .\
METHODS	Occurrence of stomatitis , pneumonia , rejection , and death were collected for 360 days after start of treatment .\
METHODS	Noncompartmental pharmacokinetic parameters were analyzed in the 11 densely sampled patients ; C ( min , TN ) was determined in the 380 patients .\
RESULTS	Mean maximum concentration ( C ( max ) ) , time to C ( max ) ( t ( max ) ) , area under the curve for the given dose interval ( AUC ( tau ) ) , and whole blood oral clearance at 3 months were 20.8 7.6 ng/mL , 3 1 h , 338 144 ngh/mL , and 10.0 5.6 L/hr , respectively .\
RESULTS	In the 11 densely sampled patients , linear regression showed that C ( min , TN ) was highly predictive of AUC ( tau ) ( r = 0.77 , P < 0.0001 ) at each analysis time point .\
RESULTS	Logistic regression showed a relationship between C ( min , TN ) in the 380 patients and pneumonia occurrence , but not between C ( min , TN ) and stomatitis , rejection , or death .\
CONCLUSIONS	In this study , the pharmacokinetic profile of sirolimus in hepatic allograft patients was consistent with that of renal transplantation recipients .\
CONCLUSIONS	With the exception of pneumonia , no correlation was observed between C ( min , TN ) and the occurrence of adverse events of interest .\
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###12684357\
BACKGROUND	Although commercial weight loss programs provide treatment to millions of clients , their efficacy has not been evaluated in rigorous long-term trials .\
OBJECTIVE	To compare weight loss and health benefits achieved and maintained through self-help weight loss vs with a structured commercial program .\
METHODS	A 2-year , multicenter randomized clinical trial with clinic visits at 12 , 26 , 52 , 78 , and 104 weeks conducted at 6 academic research centers in the United States between January 1998 and January 2001 .\
METHODS	Overweight and obese men ( n = 65 ) and women ( n = 358 ) ( body mass index , 27-40 ) aged 18 to 65 years .\
METHODS	Random assignment to either a self-help program ( n = 212 ) consisting of two 20-minute counseling sessions with a nutritionist and provision of self-help resources or to a commercial weight loss program ( n = 211 ) consisting of a food plan , an activity plan , and a cognitive restructuring behavior modification plan , delivered at weekly meetings .\
METHODS	Weight change was the primary outcome measure .\
METHODS	Secondary outcomes included waist circumference , body mass index , blood pressure , serum lipids , glucose , and insulin levels .\
RESULTS	At 2 years , 150 participants ( 71 % ) in the commercial group and 159 ( 75 % ) in the self-help group completed the study .\
RESULTS	In the intent-to-treat analysis , mean ( SD ) weight loss of participants in the commercial group was greater than in the self-help group at 1 year ( -4.3 [ 6.1 ] kg vs -1.3 [ 6.1 ] kg , respectively ; P < .001 ) and at 2 years ( -2.9 [ 6.5 ] kg vs -0.2 [ 6.5 ] kg , respectively ; P < .001 ) .\
RESULTS	Waist circumference ( P = .003 ) and body mass index ( P < .001 ) decreased more in the commercial group .\
RESULTS	Changes in blood pressure , lipids , glucose , and insulin levels were related to changes in weight in both groups , but between-group differences in biological parameters were mainly nonsignificant by year 2 .\
CONCLUSIONS	The structured commercial weight loss program provided modest weight loss but more than self-help over a 2-year period .\
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###22492374\
BACKGROUND	The association between blood homocysteine concentration and the risk of cardiovascular disease ( CVD ) remains controversial , but few studies have examined the association between MTHFR C677T ( a proxy for high homocysteine concentration ) and death from CVD .\
OBJECTIVE	The objective was to examine associations of MTHFR C677T , a proxy for high homocysteine concentrations , with CVD mortality and with all-cause mortality in a national representative prospective cohort of the US adult population before the introduction of mandatory folic acid fortification of flour .\
METHODS	We used Mendelian randomization to examine the association of MTHFR C677T with cause-specific mortality in 5925 participants by accessing the NHANES III ( 1991-1994 ) Linked Mortality File ( through 2006 ) .\
RESULTS	A comparison of homozygotes at baseline showed that individuals with a TT genotype had a 2.2-mol / L higher homocysteine and a 1.4-ng / mL lower folate concentration , respectively , than did those with a CC genotype .\
RESULTS	The TT genotype frequency varied from 1.2 % ( 95 % CI : 0.7 , 2.0 ) in non-Hispanic blacks and 11.6 % ( 95 % CI : 9.6 , 14.0 ) in non-Hispanic whites to 19.4 % ( 95 % CI : 16.7 , 22.3 ) in Mexican Americans .\
RESULTS	After adjustment for ethnic group and other CVD risk factors , the MTHFR C677T TT genotype was associated with significantly lower CVD mortality ( HR : 0.69 ; 95 % CI : 0.50 , 0.95 ) but had no significant effect on all-cause mortality ( HR : 0.79 ; 95 % CI : 0.59 , 1.05 ) .\
RESULTS	After stratification by period of follow-up , the inverse association of MTHFR with CVD mortality was significant only in the period after introduction of mandatory folic acid fortification .\
CONCLUSIONS	The inverse association of MTHFR with CVD mortality was unexpected and highlights the need for caution in interpretation of Mendelian randomization studies , which , like other observational studies , can be influenced by chance , bias , or confounding .\
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###23477161\
OBJECTIVE	To observe the clinical efficacy of Maixuekang capsule in reconvalescents of cerebral infarction and its impact on coagulation function .\
METHODS	One hundred and twenty cases of reconvalescents of cerebral infarction were randomly divided into treatment and control groups .\
METHODS	The 50 cases in the control group were provided with conventional therapy , while the 70 cases in the treatment group were provided with the combination of conventional therapy and Maixuekang capsule for 3 months .\
METHODS	Their neurological function and prothrombin time ( PT ) , activated partial thromboplastin time ( APTT ) clotting enzyme time ( TT ) , fibrinogen ( Fib ) were measured before and after treatment .\
RESULTS	After the treatment , PT , APTT and TT were prolonged compared with those before the treatment in the treatment group ( P < 0.05 ) , whereas Fib , neurological deficit scores decreased ( P < 0.01 ) and significantly different from the control group ( P < 0.05 ) .\
CONCLUSIONS	Maixuekang capsule is among safe and effective drugs in treatment of reconvalescents of cerebral infarction , and can improve the patient 's coagulation state .\
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###23862237\
OBJECTIVE	To evaluate the therapeutic effect of Compound Xuanju Capsule on type III prostatitis .\
METHODS	A total of 242 patients with type III prostatitis diagnosed by the NIH criteria were randomly divided into an experimental and a control group of equal number , the former treated with Compound Xuanju Capsule + Tamsulosin Hydrochloride , and the latter with Quinolinone antibiotics + Tamsulosin and Hydrochloride , both for 6 months .\
METHODS	After treatment , we assessed the therapeutic effects based on the NIH-CPSI scores and the improvement of relevant complications .\
RESULTS	All the 242 patients completed the treatment .\
RESULTS	The total effectiveness rate was 77.69 % ( 94/121 ) in the experimental group , 71.56 % ( 78/109 ) in those with complications .\
RESULTS	In comparison , it was only 47.10 % ( 57/121 ) in the control group , 31.78 % ( 34/107 ) in those with complications .\
RESULTS	Both the NIH-CPSI scores and the improvement of complications were significantly higher in the experimental than in the control group ( P < 0.05 ) .\
CONCLUSIONS	Compound Xuanju Capsule has a good therapeutic effect on type III prostatitis .\
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###9427455\
BACKGROUND	We compared the safety and immunogenicity of two combined diphtheria-tetanus-pertussis-inactivated poliovirus vaccines containing either acellular ( Pa , SmithKline Beecham Biologicals ) or whole cell ( Pw , Pasteur Merieux Connaught ) pertussis components , mixed with a Haemophilus influenzae type b polysaccharide polyribosylribitol phosphate-tetanus conjugate vaccine in an open , randomized study in healthy infants .\
METHODS	The combined vaccines were given at 2 , 4 , 6 and 12 months of age , and serum samples were obtained at ages 2 , 6 , 7 , 12 and 13 months .\
METHODS	Adverse events were obtained by diary cards .\
RESULTS	The Pa group ( n = 101 ) had a clearly lower incidence of both local and systemic adverse events than the Pw group ( n = 100 ) .\
RESULTS	Immunogenicity was comparable for the diphtheria and tetanus components , but significantly superior for pertussis toxin , filamentous hemagglutinin , pertactin and polioviruses 1 , 2 and 3 in the Pa group .\
RESULTS	Both groups had an appropriate response with regard to H. influenzae type b polysaccharide polyribosylribitol phosphate , but the dynamics of the response were significantly different : geometric mean concentrations ( micrograms per ml ) after the second , third and booster doses were 1.27 , 5.06 and 23.12 in the Pa group and 2.72 , 6.66 and 13.59 in the Pw group , respectively ( P = 0.0002 after second dose ; P = 0.0005 after booster ) .\
CONCLUSIONS	The presently studied diphtheria , tetanus , acellular pertussis-H .\
CONCLUSIONS	influenzae b vaccine conjugated to tetanus toxoid combination was at least as immunogenic as the diphtheria , tetanus , whole cell pertussis-H .\
CONCLUSIONS	influenzae b vaccine conjugated to tetanus toxoid combination , with a significantly better safety profile .\
CONCLUSIONS	This is of obvious importance in countries where inactivated poliovirus vaccine is part of the routine infant immunization programs .\
\
###12576829\
OBJECTIVE	We compared the incidence of hematuria , pyuria and clinical urinary tract infection in patients who performed intermittent self-catheterization using a hydrophilic coated LoFric ( Astra Tech AB , Mlndal , Sweden ) or standard plastic catheter .\
METHODS	A total of 62 male patients who performed intermittent self-catheterization to manage neurogenic bladder were randomized into 2 treatment groups at 3 American study sites .\
METHODS	Outcome measures included urinary tract infection , microhematuria , pyuria and satisfaction rates .\
RESULTS	Of the 62 enrolled patients 49 completed the 12-month study .\
RESULTS	The withdrawal rate was not different in the 2 groups .\
RESULTS	At the end of the study there was statistically significantly less hematuria in the hydrophilic coated catheter group compared with controls .\
RESULTS	In addition , there was a significant decrease in the urinary tract infection rate from baseline in the hydrophilic coated catheter group but not in controls .\
CONCLUSIONS	Use of the hydrophilic coated catheter by patients on intermittent self-catheterization is associated with less hematuria and a significant decrease in the incidence of urinary tract infections .\
CONCLUSIONS	Therefore , it may be preferable for some patients , especially those with a history of difficult catheterization , urethral trauma or a high rate of urinary tract infection .\
\
###12459668\
BACKGROUND	Protective ventilatory strategies have resulted in a decreased mortality rate in acute respiratory distress syndrome , but the underlying mechanisms remain unclear .\
BACKGROUND	The authors hypothesized that ( 1 ) mechanical ventilation modulates activation of polymorphonuclear leukocytes ( PMNs ) , ( 2 ) the consequent release of proteinases is correlated with a systemic inflammatory response and with multiple organ dysfunction , and ( 3 ) these deleterious effects can be minimized by a protective ventilatory strategy .\
METHODS	Human PMNs were incubated with bronchoalveolar lavage fluid obtained from patients at entry or 36 h after randomization to ventilation with either a conventional ( control ) or a lung-protective strategy .\
METHODS	PMN oxidant production and surface expression of adhesion molecules and granule markers , including CD18 , CD63 , and L-selectin , were measured by flow cytometry .\
METHODS	Extracellular elastase activity was quantified using a fluorescent substrate .\
RESULTS	Bronchoalveolar lavage obtained from both groups of patients at entry showed similar effects on PMN oxidant production and expression of surface markers .\
RESULTS	At 36 h , exposure of PMNs to bronchoalveolar lavage fluid from the control group resulted in increased PMN activation as manifested by a significant increase in oxidant production , CD18 , and CD63 surface expression , and shedding of L-selectin .\
RESULTS	By contrast , these variables were unchanged at 36 h in the lung-protective group .\
RESULTS	There was a significant correlation between the changes of the variables and changes in interleukin-6 level and the number of failing organs .\
CONCLUSIONS	Polymorphonuclear leukocytes can be activated by mechanical ventilation , and the consequent release of elastase was correlated with the degree of systemic inflammatory response and multiple organ failure .\
CONCLUSIONS	This result may possibly explain the decreased mortality in acute respiratory distress syndrome patients treated with a lung-protective strategy .\
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###12867686\
OBJECTIVE	To compare the efficacy of ketoprofen and pethidine for peri-operative analgesia and post-operative nausea and vomiting in children undergoing vitreoretinal surgery and surgery for retinal detachment .\
METHODS	Children aged 7 to 16 years and ASA I status , undergoing vitreo-retinal surgery were randomly allocated to receive either ketoprofen 2mg/kg or pethidine 1mg/kg intravenously for peri-operative analgesia .\
METHODS	In all patients , general anaesthesia was induced with thiopentone and intubation was facilitated with vecuronium bromide and maintained with 33 % oxygen in nitrous oxide and isoflurane .\
METHODS	Intra-operative and post-operative monitoring was done by an observer blinded to the technique .\
METHODS	Intra-operative rescue analgesia was used if heart rate and/or blood pressure increased by 25 % from pre-incision values .\
METHODS	Post-operative pain and episodes of nausea and vomiting were evaluated at recovery ( 0 hour ) , 2 , 6 and 24 hours intervals .\
METHODS	Standard rescue analgesia and anti-emetic agents were administered if required .\
RESULTS	Eighty-six children were enrolled in the study .\
RESULTS	Forty-four received ketoprofen while 42 received pethidine .\
RESULTS	Intra-operative analgesia was comparable in both the groups and no significant difference was found in the requirement of intra-operative rescue analgesia , as well .\
RESULTS	Postoperatively 6/44 ( 13.6 % ) children in ketoprofen group had pain at recovery compared to 17/42 ( 40.4 % ) in pethidine group .\
RESULTS	Pain at 2 , 6 and 24 hours , and postoperative analgesic requirement were not significantly different among the two groups .\
RESULTS	Post-operative nausea , vomiting , and antiemetic requirement were significantly less in the ketoprofen group at all time intervals .\
CONCLUSIONS	Ketoprofen is a satisfactory alternative analgesic to pethidine for vitreoretinal surgery and results in a lower incidence of postoperative nausea and vomiting .\
\
###23735957\
OBJECTIVE	The goal of this randomized , open-label phase II study was to investigate the effect of concomitant low-frequency head-motion therapy and intraventricular fibrinolysis in patients after surgical or endovascular treatment for aneurysmal subarachnoid hemorrhage .\
METHODS	Sixty patients experiencing subarachnoid hemorrhage were randomized into treatment with intraventricular application of recombinant tissue-type plasminogen activator and lateral rotational therapy ( experimental ) or treatment as usual ( control ) .\
METHODS	The primary end point was defined as functional outcome , measured by Glasgow Outcome Scale at discharge and at 3-month follow-up .\
METHODS	Clot clearance rate , radiographic features of delayed cerebral ischemia , and posthemorrhagic hydrocephalus were defined as secondary end points .\
RESULTS	The majority of patients ( 78.3 % ) experienced severe subarachnoid hemorrhage .\
RESULTS	Although there was a higher incidence of subgaleal hematomas in the experimental group , there was no difference in the incidence of adverse or severe adverse events between the 2 groups .\
RESULTS	Despite significantly higher clot clearance rates , there was no beneficial effect on the incidence of delayed cerebral ischemia and poor functional outcome , as well as posthemorrhagic hydrocephalus after experimental treatment .\
CONCLUSIONS	Despite the ineffectiveness on reduction of delayed cerebral ischemia or poor functional outcome , intraventricular fibrinolysis and kinetic therapy seems to be a safe and effective concept for therapeutic reduction of subarachnoid clot in a patient collective experiencing predominantly severe subarachnoid hemorrhage .\
CONCLUSIONS	Therefore , future studies should investigate this treatment in a larger patient collective with a lower degree of primary brain injury and until full clot clearance on serial imaging .\
BACKGROUND	http://www.controlled-trials.com .\
BACKGROUND	Unique identifier : ICRCTN13230264 .\
\
###20185272\
OBJECTIVE	Persons with serious mental illnesses ( SMI ) have elevated rates of comorbid medical conditions , but may also face challenges in effectively managing those conditions .\
METHODS	The study team developed and pilot-tested the Health and Recovery Program ( HARP ) , an adaptation of the Chronic Disease Self-Management Program ( CDSMP ) for mental health consumers .\
METHODS	A manualized , six-session intervention , delivered by mental health peer leaders , helps participants become more effective managers of their chronic illnesses .\
METHODS	A pilot trial randomized 80 consumers with one or more chronic medical illness to either the HARP program or usual care .\
RESULTS	At six month follow-up , participants in the HARP program had a significantly greater improvement in patient activation than those in usual care ( 7.7 % relative improvement vs. 5.7 % decline , p = 0.03 for group * time interaction ) , and in rates of having one or more primary care visit ( 68.4 % vs. 51.9 % with one or more visit , p = 0.046 for group * time interaction ) .\
RESULTS	Intervention advantages were observed for physical health related quality of life ( HRQOL ) , physical activity , medication adherence , and , and though not statistically significant , had similar effect sizes as those seen for the CDSMP in general medical populations .\
RESULTS	Improvements in HRQOL were largest among medically and socially vulnerable subpopulations .\
CONCLUSIONS	This peer-led , medical self-management program was feasible and showed promise for improving a range of health outcomes among mental health consumers with chronic medical comorbidities .\
CONCLUSIONS	The HARP intervention may provide a vehicle for the mental health peer workforce to actively engage in efforts to reduce morbidity and mortality among mental health consumers .\
\
###19447387\
BACKGROUND	JELIS was a large-scale clinical trial that investigated the effects of eicosapentaenoic acid ( EPA ) on coronary artery disease ( CAD ) .\
BACKGROUND	In this paper , the data of patients registered in JELIS were analysed to compare the incidence of CAD between patients with impaired glucose metabolism ( IGM ) and normoglycemic ( NG ) patients .\
BACKGROUND	The effect of EPA on the incidence of CAD in patients with IGM was also assessed .\
METHODS	The 18,645 hypercholesterolemic patients registered in JELIS were divided into two groups .\
METHODS	One group consisted of patients with IGM ( n = 4565 ) , which included the patients who had diabetes mellitus and patients who had a fasting plasma glucose of 110mg/dL or higher , either at the time of registration or after 6 months .\
METHODS	The other group consisted of NG patients ( n = 14,080 ) .\
METHODS	CAD incidence of the two groups over the average 4.6-year follow-up period was compared , and the effect of EPA was assessed .\
RESULTS	Compared to NG patients , IGM patients had a significantly higher CAD hazard ratio ( 1.71 in the non-EPA group and 1.63 in the EPA group ) .\
RESULTS	The treatment with EPA resulted in a 22 % decrease in the CAD incidence ( P = 0.048 ) in IGM patients and an 18 % decrease ( P = 0.062 ) in NG patients .\
CONCLUSIONS	It was found that the CAD risk in IGM patients is higher than in NG patients , and that highly purified EPA is very effective in decreasing the incidence of CAD among Japanese IGM patients , even though the intake of fish is high .\
\
###8012622\
OBJECTIVE	To obtain a baseline measure of tobacco control activities carried out by physicians and of tobacco control policies and practices in physician offices .\
METHODS	All primary care physicians in 11 communities were asked through a mail survey about their tobacco control practices .\
METHODS	Thirty offices in each community were randomly selected and interviewed by telephone to determine office policies and practices .\
METHODS	Both surveys assessed primary care settings in the 11 intervention communities .\
RESULTS	The physicians ' survey ( response rate , 48 % ) indicated that physicians report intervention with smokers more than 70 % of the time , but the interventions rarely include key behavioral elements necessary for smoking modification .\
RESULTS	Physicians who received formal training in smoking cessation reported that they believed themselves to be more prepared and that they spent more time counseling patients than physicians who were not trained .\
RESULTS	The office survey ( response rate , 83.2 % ) indicated that smoke-free policies are in place in most clinics and offices and that many offices provide printed materials on smoking cessation .\
RESULTS	However , few offices had staff to coordinate smoking cessation activities .\
RESULTS	These surveys will be repeated following the intervention phase of the Community Intervention Trial for Smoking Cessation to assess changes in counseling practices and office policies .\
CONCLUSIONS	There is a positive relationship between attending training and intervening with more cessation activities .\
CONCLUSIONS	Physicians perceive themselves as prepared to help smokers , but few are providing more than advice to stop smoking .\
\
###9871862\
OBJECTIVE	To evaluate the efficacy and safety of timolol hemihydrate once daily versus timolol maleate gel forming solution once daily in patients with primary open-angle glaucoma or ocular hypertension .\
METHODS	We prospectively randomized patients with primary open-angle glaucoma or ocular hypertension to receive either timolol hemihydrate 0.5 % solution or timolol maleate gel forming solution 0.5 % every morning .\
METHODS	The primary efficacy variable was the 8:00 AM trough intraocular pressure ( IOP ) 24 hours after administration .\
RESULTS	Three months after initiation of therapy , baseline IOP had decreased from 23.6 + / - 1.9 mmHg to 18.3 + / - 2.8 mmHg in the group taking timolol hemihydrate ( n = 22 ) and from 23.7 + / - 2.2 mmHg to 18.4 + / - 3.1 mmHg in the group receiving timolol maleate gel ( n = 21 ) at the 24-hour trough level .\
RESULTS	This was not a significant difference between groups at 3 months .\
RESULTS	Also , no difference was observed between groups in the 2-hour post instillation IOP .\
RESULTS	Visual acuity was decreased in the group receiving timolol maleate gel compared with those receiving timolol hemihydrate one minute after instillation of study medicine at month 3 .\
RESULTS	Otherwise , ocular and systemic safety were similar between groups .\
RESULTS	No differences between groups in cardiac pulse or systolic and diastolic blood pressure were observed .\
CONCLUSIONS	Timolol hemihydrate 0.5 % solution given once a day appears to be as efficacious and safe in decreasing IOP as timolol maleate gel 0.5 % given once a day .\
\
###24096105\
OBJECTIVE	Telephone-CPR ( T-CPR ) can increase initiation of bystander CPR .\
OBJECTIVE	We wanted to study if quality oriented continuous T-CPR would improve CPR performance vs. standard T-CPR .\
METHODS	Ninety-five trained rescuers aged 22-69 were randomized to standard T-CPR or experimental continuous T-CPR ( comprises continuous instructions , questions and encouragement ) .\
METHODS	They were instructed to perform 10 min of chest compressions-only on a manikin , which recorded CPR performance in a small , confined kitchen .\
METHODS	Three video-cameras captured algorithm time data , CPR technique and communication .\
METHODS	Demography and training experience were captured during debriefing .\
RESULTS	Participants receiving continuous T-CPR delivered significantly more chest compressions ( median 1000 vs. 870 compressions , p = 0.014 ) and compressed more frequently to a compression rate between 90 and 120 min ( -1 ) ( median 87 % vs. 60 % of compressions , p < 0.001 ) , compared to those receiving standard T-CPR .\
RESULTS	This also resulted in less time without compressions after CPR had started ( median 12s vs. 64 s , p < 0.001 ) , but longer time interval from initiating contact with dispatcher to first chest compression ( median 144 s vs. 84 s , p < 0.001 ) .\
RESULTS	There was no difference in chest compression depth ( mean 47 mm vs. 48 mm , p = 0.90 ) or in demography , education and previous CPR training between the groups .\
CONCLUSIONS	In our simulated scenario with CPR trained lay rescuers , experimental continuous T-CPR gave better chest compression rate and less hands-off time during CPR , but resulted in delayed time to first chest compression compared to standard T-CPR instructions .\
\
###10192200\
BACKGROUND	Preliminary results from combination therapy with interferon-alpha and ribavirin ( IFN/Rib ) in patients with chronic hepatitis C have been promising , with up to 50 % sustained hepatitis C virus ( HCV ) RNA response .\
BACKGROUND	The aim of this study was to investigate whether a sustained HCV RNA response could be obtained with combination therapy in patients who were non-responders or relapsers after IFN treatment .\
METHODS	In a multicenter study we randomized 53 HCV RNA-positive patients into 2 treatment groups .\
METHODS	They all had biopsy-confirmed chronic hepatitis C , and all were recruited from a previous IFN study : 26 were previous non-responders and 27 responders with relapse .\
METHODS	Group A received interferon-alpha2a , 4.5 MIU thrice weekly for 6 months , and group B received ribavirin , 1000-1200 mg/day , in combination with the same dose of interferon-alpha2a for 6 months .\
METHODS	Median Knodell index was 5.0 in both groups .\
METHODS	Genotype 1 was found in 24 ( 45 % ) , type 2 in 3 ( 6 % ) , and type 3 in 26 ( 49 % ) .\
RESULTS	Sustained clearance of HCV viremia 6 months after interferon-alpha2a treatment stop was obtained in 12 of 53 patients ( 23 % ) : 6 of 27 in the IFN group ( 22 % ) and 6 of 26 ( 23 % ) in the IFN/Rib group ( NS ) .\
RESULTS	Nine of 27 ( 33 % ) former responders with relapse , compared with 3 of 26 ( 12 % ) non-responders , obtained a sustained HCV RNA response ( P = 0.054 ) .\
RESULTS	In previous relapse patients sustained loss of viremia was more frequent in genotype 3 ( 50 % ) than in genotype 1 ( 11 % ) patients ( P = 0.022 ) .\
CONCLUSIONS	In a group of previous IFN-alpha2a-treated chronic HCV patients we obtained a similar sustained clearance of viremia when retreated either with IFN-alpha2a alone or with a combination of IFN-alpha2a and ribavirin for 6 months .\
CONCLUSIONS	Previous relapse patients with HCV genotype 3 obtained sustained loss of viremia significantly more often ( 50 % ) than type-patients ( 11 % ) .\
CONCLUSIONS	Previous IFN responders with relapse responded better than previous non-responders .\
\
###12684609\
OBJECTIVE	The atypical antipsychotics , amisulpride and risperidone , have different receptor affinity characteristics .\
OBJECTIVE	Although the relative efficacy of both drugs compared to conventional antipsychotics is well established , it remains unclear how the efficacy of amisulpride compares with risperidone .\
OBJECTIVE	There have been no controlled studies comparing amisulpride to risperidone in Asian patients .\
OBJECTIVE	The purpose of this study was to compare the efficacy and safety of amisulpride with that of risperidone in Taiwanese schizophrenic patients .\
METHODS	Patients with productive positive symptoms ( n = 48 ) were enrolled into this double-blind , randomized pilot study for 6 weeks .\
METHODS	Patients received either amisulpride ( 400-800 mg/day ) or risperidone ( 4-8 mg/day ) .\
METHODS	Positive and Negative Syndrome Scale ( PANSS ) , Clinical Global Impression ( CGI ) , Social and Occupational Functioning Assessment Scale ( SOFAS ) , and patients ' subjective responses to treatment were assessed during the trial period .\
METHODS	Adverse events were recorded at each follow-up visit .\
RESULTS	At the end of the trial , the mean dosage was 630 + / - 134 mg/day and 6.88 + / - 1.54 mg/day for amisulpride and risperidone , respectively .\
RESULTS	There was no significant difference in the reduction of the PANSS total score ( amisulpride -24.1 versus risperidone -28.4 , p = 0.999 ) , the PANSS positive subscale score ( amisulpride -6.8 versus risperidone -8.3 , p = 0.467 ) , the PANSS negative subscale score ( amisulpride -5.6 versus risperidone -6.4 , p = 0.999 ) , or the CGI score between the two groups .\
RESULTS	The extrapyramidal symptom ratings , the improvement in the SOFAS ( amisulpride 11.1 versus risperidone 10.0 ) and the subjective response ( amisulpride 82 % versus risperidone 83 % ) were comparable .\
RESULTS	No serious adverse events were recorded in either treatment group .\
RESULTS	There was a statistically significant body weight gain in the risperidone group .\
RESULTS	In contrast , there was a statistically , though not clinically , significant reduction of blood pressure and heart rate in the amisulpride group .\
CONCLUSIONS	This study suggests that amisulpride is as effective as risperidone in the treatment of patients with schizophrenia .\
CONCLUSIONS	Both drugs were well tolerated , but had different side effect profiles .\
\
###12719279\
BACKGROUND	Despite the established efficacy of statins , many patients do not achieve recommended LDL cholesterol ( LDL-C ) goals .\
BACKGROUND	Contributing factors may be inadequate dosing , increased risk for adverse effects with high-dose monotherapy , and increased potential for intolerance and adverse effects with combinations of available agents .\
RESULTS	In a double-blind study , 628 patients with baseline LDL-C 145 to 250 mg/dL and triglycerides < or = 350 mg/dL were randomly assigned to receive 1 of the following for 12 weeks : ezetimibe ( 10 mg/d ) ; atorvastatin ( 10 , 20 , 40 , or 80 mg/d ) ; ezetimibe ( 10 mg ) plus atorvastatin ( 10 , 20 , 40 , or 80 mg/d ) ; or placebo .\
RESULTS	The primary efficacy end point was percentage reduction in LDL-C for pooled ezetimibe plus atorvastatin versus pooled atorvastatin treatment groups .\
RESULTS	Ezetimibe plus atorvastatin significantly improved LDL-C , HDL cholesterol ( HDL-C ) , triglycerides , total cholesterol : HDL-C , and high-sensitivity C-reactive protein ( hs-CRP ) compared with atorvastatin alone ( P < 0.01 ) .\
RESULTS	Coadministration of ezetimibe provided a significant additional 12 % LDL-C reduction , 3 % HDL-C increase , 8 % triglyceride reduction , and 10 % hs-CRP reduction versus atorvastatin alone .\
RESULTS	Ezetimibe plus atorvastatin provided LDL-C reductions of 50 % to 60 % , triglyceride reductions of 30 % to 40 % , and HDL-C increases of 5 % to 9 % , depending on atorvastatin dose .\
RESULTS	LDL-C reductions with ezetimibe plus 10 mg atorvastatin ( 50 % ) and 80 mg atorvastatin alone ( 51 % ) were similar .\
CONCLUSIONS	Ezetimibe plus atorvastatin was well tolerated , with a safety profile similar to atorvastatin alone and to placebo .\
CONCLUSIONS	When coadministered with atorvastatin , ezetimibe provided significant incremental reductions in LDL-C and triglycerides and increases in HDL-C .\
CONCLUSIONS	Coadministration of ezetimibe and atorvastatin offers a well-tolerated and highly efficacious new treatment option for patients with hypercholesterolemia .\
\
###18182188\
BACKGROUND	Occlusal disharmony due to processing can cause discomfort to the patient .\
OBJECTIVE	The purpose of this investigation was to identify whether refinement in occlusion was correlated with patient comfort and the number of postinsertion visits .\
METHODS	Maxillary and mandibular complete dentures were fabricated for 30 subjects who were randomly divided into 3 groups of 10 subjects using a lottery : Group LCRO , the control group , received both laboratory and clinical remount procedures along with occlusal corrections ; Group LRO subjects received only laboratory remount with occlusal corrections ; and Group OOC subjects underwent routine procedures in complete denture construction without remount corrections and only occlusal corrections where required , intraorally .\
METHODS	A pilot study was conducted to identify the feasibility of a close-ended questionnaire designed by the investigator and containing 5 questions regarding the comfort , pain , masticatory ability , swallowing , and occlusal contacts of maxillary and mandibular complete dentures .\
METHODS	The evaluation was performed following the subject 's use of the dentures for 7 days .\
METHODS	All 30 subjects were examined for tissue irritation at this time .\
METHODS	The evaluation was conducted by a single examiner who was unaware of the groups to which the subjects belonged .\
METHODS	An analysis of statistical difference between the treatment groups for the number of postinsertion visits , comfort , pain during mastication , swallowing , and areas of tissue irritation during use of complete dentures was assessed using the chi-square test and Kruskal-Wallis test ( alpha = .05 ) .\
RESULTS	The results indicated that remount procedures and occlusal corrections significantly reduced the number of postinsertion visits ( Kruskal-Wallis test , P < .001 ) .\
RESULTS	There was less pain during mastication in group LCRO compared to the other groups ( Kruskal-Wallis test , P = .0399 ) .\
RESULTS	Group LCRO subjects also reported less incidence of tissue irritation compared to group LRO and group OOC ( chi2 = 18.26 , P < .001 )\
CONCLUSIONS	The combination of laboratory and clinical remount procedures with occlusal corrections enhanced patient comfort , compared to the other groups in which either one or both of the procedures were not performed .\
\
###10733124\
OBJECTIVE	Pyrimidine nucleoside phosphorylase is an enzyme that converts 5 ' - deoxy-5-fluorouridine into its active metabolite , 5-fluorouracil .\
OBJECTIVE	In colorectal cancer tissue pyrimidine nucleoside phosphorylase has been proven to be produced by macrophages in the cancer stroma despite presence of the cancer cells .\
OBJECTIVE	We reported that local immunotherapy with OK-432 and fibrinogen induced aggregation of macrophages in the cancer stroma and enforced their pyrimidine nucleoside phosphorylase expression .\
OBJECTIVE	Thus it was hypothesized that if colon cancer were treated with 5 ' - deoxy-5-fluorouridine , the 5-fluorouracil concentration in cancer tissues would be enhanced by local immunotherapy .\
OBJECTIVE	The present study was conducted to investigate whether local immunotherapy for colon cancer could increase the intratumoral 5-fluorouracil concentration in patients given chemotherapy with 5 ' - deoxy-5-fluorouridine .\
METHODS	Twenty patients with resectable colorectal cancer were examined in this study .\
METHODS	They were given 5 ' - deoxy-5-fluorouridine ( 600 mg/day ) orally for seven days preoperatively .\
METHODS	Nine randomly selected patients underwent intratumoral injection of OK-432 mixed with fibrinogen , which was performed on the third preoperative day ( OK-432 and fibrinogen plus 5 ' - deoxy-5-fluorouridine group ) ; eleven patients were given oral 5 ' - deoxy-5-fluorouridine only ( 5 ` deoxy-5-fluorouridine group ) .\
METHODS	The 5-fluorouracil concentration in tumor tissue and normal colon mucosa tissue was measured , and the influence of the local immunotherapy was assessed .\
RESULTS	The 5-fluorouracil concentration in the cancer tissue was increased by the local immunotherapy , whereas that in the normal colon mucosa was not influenced .\
RESULTS	Thus , the influence of local immunotherapy was selective to the cancer tissue where the mixture of OK-432 and fibrinogen was injected .\
CONCLUSIONS	In patients with colorectal cancer , selective high 5-fluorouracil concentration in the cancer tissue could be achieved by a combination of 5 ' - deoxy-5-fluorouridine and local immunotherapy with a mixture of OK-432 and fibrinogen .\
\
###23743559\
BACKGROUND	Short antiviral therapy has been proposed for patients with chronic hepatitis C , easy genotypes , low fibrosis score , low viral load at baseline , and rapid virological response ( RVR ) .\
BACKGROUND	However , this approach is not completely accepted .\
OBJECTIVE	The aims of this study were ( a ) to evaluate the sustained virological response ( SVR ) in noncirrhotic patients with genotype 2 or 3 , achieving an RVR , randomized to receive pegylated-interferon ( IFN ) -2 b plus ribavirin for either 16 or 24 weeks and ( b ) to carry out direct cost analysis comparing patients treated for 16 versus 24 weeks .\
RESULTS	Of the 142 initially evaluated patients , 130 were enrolled according to the selection criteria , but independent of the viral load .\
RESULTS	According to the intention-to-treat analysis , SVR was achieved in 104 patients ( 80 % ) .\
RESULTS	Logistic regression analysis showed that RVR ( P < 0.001 ) and genotype 2 ( P < 0.03 ) were the most important factors independently associated with SVR .\
RESULTS	Among patients with RVR , SVR was comparable between patients treated for 16 weeks and those treated for 24 weeks ( 86.2 vs. 89.7 % , P = NS ) .\
RESULTS	The mean direct costs were 4003.7 for patients treated for 16 weeks and 5676.7 for those treated for 24 weeks , with a 30 % difference between the two arms .\
CONCLUSIONS	In patients achieving an RVR , a 16-week treatment with pegylated-interferon plus ribavirin was comparable to a 24-week treatment .\
CONCLUSIONS	Short treatment in patients with RVR allows us to save 30 % of the direct costs , independent of the viral load at baseline .\
\
###22680916\
OBJECTIVE	The purpose of this study was to compare continuous femoral nerve analgesia to oral opioid analgesics after discontinuation of epidural analgesia following total knee replacement .\
METHODS	Randomized prospective controlled parallel group trial .\
METHODS	Setting .\
METHODS	Large tertiary university teaching hospital in a major Midwestern city .\
METHODS	Subjects .\
METHODS	Sixty-two subjects were randomized to receive neuraxial anesthesia followed by either oral analgesics ( N = 31 ) or continuous femoral nerve analgesia ( N = 31 ) .\
METHODS	After discontinuation of epidural anesthesia on the morning after surgery , continuous femoral nerve analgesia ( CFA ) , ropivacaine 25 mg bolus and 5 mg/h infusion was initiated .\
METHODS	Catheters were removed 24 hours later .\
METHODS	All subjects received oral opioid analgesics as needed .\
METHODS	The primary outcome measure was knee flexion at 1 month .\
METHODS	Physical therapy assessments , pain scores , opioid consumption , and patient satisfaction were assessed during hospitalization .\
METHODS	Knee flexion , pain scores , and opioid consumption were collected at 1 , 6 , and 12 months , and health-related quality of life was collected at 6 and 12 months .\
METHODS	RESULTS ; The median difference ( 95 % CI ) in the change in knee flexion from baseline was 7.5 ( 0 to 15 ) degrees greater after CFA ( P = 0.04 ) at 1 month .\
METHODS	CFA subjects had greater compliance with physical therapy , reduced pain scores , and opioid requirements during hospitalization .\
METHODS	Thromboembolic events occurred in 0/31 CFA vs 4/31 non-CFA subjects ( P = 0.04 ) .\
CONCLUSIONS	CFA for 24 hours following discontinuation of epidural analgesia was associated with lower pain scores , greater compliance with physical therapy , increased range of motion , reduced opioid analgesia use , and greater patient satisfaction during hospitalization .\
CONCLUSIONS	The increased flexion of the operated joint was still evident at 1 month postoperatively .\
\
###22361799\
OBJECTIVE	To explore variations both in interview ratings data and in medical school admissions decisions when current medical students do and do not participate in interviewing applicants .\
METHODS	The research team conducted this randomized controlled trial by performing identical analyses for each of six independent cohorts of applicants ( n = 3,868 ) to Baylor College of Medicine for the academic years 2005-2006 through 2010-2011 .\
METHODS	A pair of randomly selected interviewers -- either two faculty members or a faculty member and a student -- interviewed each applicant in a one-on-one interview .\
RESULTS	Interviewer pairs randomly structured to include either two faculty members ( n = 1,523 ) or one faculty member and one student ( n = 2,345 ) produced ratings of similar means as well as homogeneity across ratings .\
RESULTS	The structure of the rater pairs , as expected , was not predictive of the final admissions decisions after the authors took into account Medical College Admission Test scores and grade point average .\
CONCLUSIONS	These results , showing that student involvement does not compromise the ratings of interviewed applicants , support the continued involvement of students in medical school admissions interviews .\
\
###20301228\
OBJECTIVE	To evaluate the effectiveness of patient-led teaching compared with doctor-led teaching , regarding the impact of chronic disease ( rheumatoid arthritis [ RA ] ) .\
METHODS	A set of learning objectives regarding the impact of RA on patient and family was designed .\
METHODS	Students ( n = 42 ) attached to the academy for their musculoskeletal diseases module were randomized to teaching either by a doctor or a patient .\
METHODS	Outcome was assessed using a knowledge test , feedback forms and qualitative written interview .\
RESULTS	In the knowledge test , the groups performed equally .\
RESULTS	The patient-taught group scored 24.5 + / - 3.5 ( max 35 ) ; the doctor-taught group scored 24.6 + / - 4.1 ( p > 0.05 ; NS ) .\
RESULTS	Feedback was completed by 40/42 students .\
RESULTS	Mean scores for the overall grading of teaching ( 1-5 , where 1 = worst , 5 = best ) were : patient teaching 4.36 ( 95 % confidence interval [ CI ] 4.11 , 4.61 ) ; doctor teaching 3.69 ( 95 % CI 3.52 , 3.92 ) .\
RESULTS	The difference between the average scores was 0.42 ( p = 0.005 ) .\
RESULTS	Qualitative feedback showed recurring themes that students appreciated the personal nature of the patient 's teaching , enabling them to understand the impact of the disease on patients and their families .\
RESULTS	The doctors ' teaching was also appreciated , particularly the interactive style and opportunity to participate in role play .\
CONCLUSIONS	We have demonstrated that our patient was at least as good as a doctor at teaching about the impact of chronic disease on patients .\
CONCLUSIONS	Furthermore , this experience is valued by students who appreciate the personal insight that a patient can offer .\
\
###21067717\
OBJECTIVE	To analyze the impact of LH administration on cycle outcome in ovarian stimulation with GnRH antagonists .\
METHODS	Randomized , open-label , controlled trial performed in two age subgroups .\
METHODS	Recombinant ( r ) FSH versus rFSH + rLH administration was compared .\
METHODS	University-affiliated private infertility clinic .\
METHODS	Up to 35 years old ( n = 380 ) and aged 36 to 39 years ( n = 340 ) , undergoing their first or second IVF cycle .\
METHODS	Recombinant LH administration since stimulation day 1 .\
METHODS	Implantation rate , ongoing pregnancy rate .\
RESULTS	In the young population , implantation rates were similar : 27.8 % versus 28.6 % , odds ratio ( OR ) 1.03 ( 95 % confidence interval [ CI ] 0.73-1 .47 ) , as was the ongoing pregnancy rate per started cycle : 37.4 % versus 37.4 % , OR 1.0 ( 95 % CI 0.66-1 .52 ) .\
RESULTS	In older patients , the implantation rate was significantly higher in the rFSH + rLH group : 26.7 % versus 18.6 % , OR 1.56 ( 95 % CI 1.04-2 .33 ) .\
RESULTS	Ongoing pregnancy rates per started cycle were 33.5 % versus 25.3 % , OR 1.49 ( 95 % CI 0.93-2 .38 ) .\
CONCLUSIONS	Recombinant LH administration significantly increased the implantation rate in patients aged 36 to 39 years .\
CONCLUSIONS	A clinically relevant better ongoing pregnancy rate per started cycle was observed , although the difference was not statistically significant .\
CONCLUSIONS	Patients younger than 36 years do not obtain any benefit from rLH administration .\
\
###21771987\
BACKGROUND	Premenopausal patients with breast cancer are at high risk of premature ovarian failure induced by systemic treatments , but no standard strategies for preventing this adverse effect are yet available .\
OBJECTIVE	To determine the effect of the temporary ovarian suppression obtained by administering the gonadotropin-releasing hormone analogue triptorelin during chemotherapy on the incidence of early menopause in young patients with breast cancer undergoing adjuvant or neoadjuvant chemotherapy .\
METHODS	The PROMISE-GIM6 ( Prevention of Menopause Induced by Chemotherapy : A Study in Early Breast Cancer Patients-Gruppo Italiano Mammella 6 ) study , a parallel , randomized , open-label , phase 3 superiority trial , was conducted at 16 sites in Italy and enrolled 281 patients between October 2003 and January 2008 .\
METHODS	The patients were premenopausal women with stage I through III breast cancer who were candidates for adjuvant or neoadjuvant chemotherapy .\
METHODS	Assuming a 60 % rate of early menopause in the group treated with chemotherapy alone , it was estimated that 280 patients had to be enrolled to detect a 20 % absolute reduction in early menopause in the group treated with chemotherapy plus triptorelin .\
METHODS	The intention-to-treat analysis was performed by including all randomized patients and using imputed values for missing data .\
METHODS	Before beginning chemotherapy , patients were randomly allocated to receive chemotherapy alone or combined with triptorelin .\
METHODS	Triptorelin was administered intramuscularly at a dose of 3.75 mg at least 1 week before the start of chemotherapy and then every 4 weeks for the duration of chemotherapy .\
METHODS	Incidence of early menopause ( defined as no resumption of menstrual activity and postmenopausal levels of follicle-stimulating hormone and estradiol 1 year after the last cycle of chemotherapy ) .\
RESULTS	The clinical and tumor characteristics of the 133 patients randomized to chemotherapy alone and the 148 patients randomized to chemotherapy plus triptorelin were similar .\
RESULTS	Twelve months after the last cycle of chemotherapy ( last follow-up , August 18 , 2009 ) , the rate of early menopause was 25.9 % in the chemotherapy-alone group and 8.9 % in the chemotherapy plus triptorelin group , an absolute difference of -17 % ( 95 % confidence interval , -26 % to -7.9 % ; P < .001 ) .\
RESULTS	The odds ratio for treatment-related early menopause was 0.28 ( 95 % confidence interval , 0.14 to 0.59 ; P < .001 ) .\
CONCLUSIONS	The use of triptorelin-induced temporary ovarian suppression during chemotherapy in premenopausal patients with early-stage breast cancer reduced the occurrence of chemotherapy-induced early menopause .\
BACKGROUND	clinicaltrials.gov Identifier : NCT00311636 .\
\
###22878377\
OBJECTIVE	To investigate if instrumentation ( unilateral vs. bilateral fixation ) has an effect on the rate of fusion cage migration .\
METHODS	This clinical study of transforaminal lumbar interbody fusion involved a prospective group of 116 patients who were randomly assigned to either unilateral ( n = 57 ) or bilateral ( n = 59 ) fixation .\
METHODS	Fourteen were lost to follow-up ( 11 from the unilateral group and 3 from the bilateral group ) .\
RESULTS	The unilateral fixation group consisted of 20 male and 26 female patients .\
RESULTS	In the unilateral group , the mean age was 53.5 years ( range , 18-77 ) , and the preoperative diagnosis consisted of degenerative disc disease , with or without herniated disc ( n = 44 ) , and degenerative spondylolisthesis with spinal stenosis ( n = 2 ) .\
RESULTS	The bilateral fixation group consisted of 20 male and 36 female patients .\
RESULTS	In the bilateral group , the mean age was 55.7 years ( range , 26-82 ) , and the preoperative diagnosis consisted of degenerative disc disease , with or without herniated disc ( n = 40 ) , and degenerative spondylolisthesis with spinal stenosis ( n = 16 ) .\
RESULTS	A total of 17 cases of cage migration were found ; of these , 11 were from the unilateral group and 6 from the bilateral group , resulting in rates of cage migration of 23 and 11 % ( p = 0.03 ) , respectively .\
RESULTS	In regard to migration cases , 5 were male and 12 were female .\
RESULTS	Ages ranged from 27 to 79 years ( mean age , 55 years ) .\
CONCLUSIONS	We conclude that unilateral fixation is not stable enough to prevent fusion cage migration in some patients who undergo TLIF .\
\
###20236813\
OBJECTIVE	In a double-blind , randomized , controlled , multicentric study , the study compared the efficacy of a specific adapted formula ( lactose-free , high-mineral , low-osmolarity formula , containing rice and pectin fortified with Saccharomyces boulardii ) in the management of infants with acute diarrhea with a standard formula used to feed healthy infants from birth .\
METHODS	Seventy infants with an average age of 163 days + / -11.7 suffering from acute diarrhea with an average of 6.6 + / -0.4 stools per day received , after randomization , either a standard ( control ) formula ( n = 36 ) or an adapted lactose-free formula fortified with S. boulardii ( 26mg/100ml ; n = 34 ) .\
METHODS	The duration of the diarrhea was defined as the time needed until the occurrence of the first normal stool after the last liquid stool .\
RESULTS	At inclusion , the age , weight , and number of stools per day were the same in the two groups .\
RESULTS	There were 15 infants with rotavirus in the treated group and 13 in the control group .\
RESULTS	The duration of the diarrhea from time of inclusion was significantly reduced in the treated group ( 35.4 + / -3.7 h ) versus the control group ( 67.1 + / -5 h ; p < 0.001 ) , In both groups , with or without rotavirus , the duration of diarrhea did not depend on the presence or absence of rotavirus but only on the treatment .\
RESULTS	The average daily weight gain was significantly higher in the treated group compared with the control group ( 74.2 + / -26.4 g versus 23.7 + / -6.7 g ; p < 0.05 ) .\
RESULTS	The oral rehydration solution consumption was , however , higher in the control group than in the treated group ; the consumption of formula was higher in the treated group , but these differences were not significant .\
RESULTS	The number of stools as of Day 4 remained significantly higher in the control group than in the treated group .\
RESULTS	After 6.5 days , almost no S. boulardii was found in the stools .\
CONCLUSIONS	In moderately dehydrated infants ( < 10 % ) , the use of a specially designed formula , containing S. boulardii ( Novalac AD + / Diarinova + ) , significantly shortens the duration of diarrhea and allows quicker weight regain than a standard formula .\
\
###24192245\
BACKGROUND	Inguinal hernia is a common condition that affects millions of people world-wide every year .\
BACKGROUND	In Denmark ( population of 5.5 million ) , more than 10,000 repairs of inguinal hernias are performed annually .\
BACKGROUND	The optimal surgical procedure for mesh placement and fixation is still being debated because of long-term complications such as persisting pain and impairment of sexual function .\
BACKGROUND	The Onstep approach is a newer type of groin hernia repair with promising preliminary results in terms of very few cases of chronic pain and recurrences .\
BACKGROUND	This protocol describes a randomised clinical trial the objective of which is to evaluate chronic pain and sexual dysfunction after inguinal hernia repair using the Lichtenstein repair compared with the Onstep approach .\
METHODS	The study is designed as a two-arm blinded multicentre , randomised clinical trial , currently involving five centres in Denmark and with ongoing recruitment .\
METHODS	The plan is to recruit a total of 282 patients ( Lichtenstein , n = 141 and Onstep , n = 141 ) and to perform one-year follow-ups .\
METHODS	Follow-up will be done by clinical examination , phone interviews and questionnaires .\
CONCLUSIONS	This study will be the first randomised clinical trial to compare the Lichtenstein repair with the Onstep technique .\
CONCLUSIONS	The results are important in order to guide further research and clinical guidelines for inguinal hernia repair .\
BACKGROUND	The study was funded in part by Bard Europe .\
BACKGROUND	NCT01753219 ( clinicaltrials.gov ) .\
\
###7545889\
BACKGROUND	A prospective clinical trial was undertaken to compare the efficacy of tacrolimus ( FK 506 ) versus cyclosporine as the primary immunosuppressive agent after lung transplantation .\
METHODS	Between October 1991 and May 1994 , 133 single-lung and bilateral-lung recipients were randomized to receive either cyclosporine ( n = 67 ) or tacrolimus ( n = 66 ) .\
METHODS	The two groups were similar in age , sex , and underlying disease .\
RESULTS	One-year and 2-year survival rates were similar in the two groups , although the trend was toward increased survival with tacrolimus .\
RESULTS	Acute rejection episodes per 100 patient-days were fewer ( p = 0.07 ) in the tacrolimus group ( 0.85 ) than in the cyclosporine group ( 1.09 ) .\
RESULTS	Obliterative bronchiolitis developed in significantly fewer patients in the tacrolimus group ( 21.7 % ) compared with the cyclosporine group ( 38 % ) ( p = 0.025 ) , and there was greater freedom from obliterative bronchiolitis over time for patients receiving tacrolimus ( p < 0.03 ) .\
RESULTS	Significantly more cyclosporine-treated patients ( n = 13 ) required crossover to tacrolimus than tacrolimus-treated patients to cyclosporine ( n = 2 ) ( p = 0.02 ) .\
RESULTS	The switch to tacrolimus controlled persistent acute rejection in 6 of 9 patients .\
RESULTS	The overall incidence of infections was similar in the two groups , although bacterial infections were more common with cyclosporine ( p = 0.0375 ) , whereas the risk of fungal infection was higher with tacrolimus ( p < 0.05 ) .\
CONCLUSIONS	This trial demonstrates the advantage of tacrolimus in reducing the risk of obliterative bronchiolitis , the most important cause of long-term morbidity and mortality after lung transplantation .\
\
###17470161\
OBJECTIVE	To establish whether androgen deprivation therapy ( ADT ) promotes osteoporosis and osteopenia\
METHODS	Ninety-four prostatectomized men with rising prostrate-specific antigen ( PSA ) were enrolled into the placebo group ( 31 ) , monthly i.v. clodronate ( 39 ) or monthly i.v. zoledronic acid ( 24 ) groups for 36 months .\
METHODS	Dual-energy X-ray absorptiometry measured the bone density in the lumbar ( L2-L4 ) area .\
METHODS	chi ( 2 ) and anova tests were used to analyze data .\
RESULTS	After 6 months of androgen deprivation , 17 of the 31 control cases developed osteopenia in the lumbar area .\
RESULTS	At 12 months , nine control cases had osteoporosis with 13 additional cases of osteopenia .\
RESULTS	At the end of the 36-month study period , the untreated group showed an average bone mineral density ( BMD ) loss of -1.82 ( + / -0.94 ) with 13 cases of osteopenia and 18 cases of osteoporosis .\
RESULTS	The clodronate group had two cases of osteoporosis out of 39 subjects after 6 months of ADT with 28 developing osteopenia and seven cases of osteoporosis after 36 months of follow up .\
RESULTS	Mean BMD loss in this group was -0.72 ( + / -0.34 ) .\
RESULTS	The zoledronic acid studied arm had seven cases of osteopenia after 6 months of ADT while 20 and five cases developed osteopenia and osteoporosis , respectively , after 36 months of follow up .\
RESULTS	The former group had a mean bone loss of -0.88 ( + / -0.32 ) .\
RESULTS	There was statistical difference for BMD loss in the treated groups starting at 6 months in comparison to the control group .\
CONCLUSIONS	Six months of ADT promoted impressive bone loss in the lumbar area of the non-treated patients .\
CONCLUSIONS	This tendency is progressive and may be delayed by i.v. bisphosphonates .\
\
###17307102\
BACKGROUND	Early improvements in disease-free survival have been noted when an aromatase inhibitor is given either instead of or sequentially after tamoxifen in postmenopausal women with oestrogen-receptor-positive early breast cancer .\
BACKGROUND	However , little information exists on the long-term effects of aromatase inhibitors after treatment , and whether these early improvements lead to real gains in survival .\
METHODS	4724 postmenopausal patients with unilateral invasive , oestrogen-receptor-positive or oestrogen-receptor-unknown breast cancer who were disease-free on 2-3 years of tamoxifen , were randomly assigned to switch to exemestane ( n = 2352 ) or to continue tamoxifen ( n = 2372 ) for the remainder of a 5-year endocrine treatment period .\
METHODS	The primary endpoint was disease-free survival ; overall survival was a secondary endpoint .\
METHODS	Efficacy analyses were intention-to-treat .\
METHODS	This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN11883920 .\
RESULTS	After a median follow-up of 55.7 months ( range 0-89 .7 ) , 809 events contributing to the analysis of disease-free survival had been reported ( 354 exemestane , 455 tamoxifen ) ; unadjusted hazard ratio 0.76 ( 95 % CI 0.66-0 .88 , p = 0.0001 ) in favour of exemestane , absolute benefit 3.3 % ( 95 % CI 1.6-4 .9 ) by end of treatment ( ie , 2.5 years after randomisation ) .\
RESULTS	222 deaths occurred in the exemestane group compared with 261 deaths in the tamoxifen group ; unadjusted hazard ratio 0.85 ( 95 % CI 0.71-1 .02 , p = 0.08 ) , 0.83 ( 0.69-1 .00 , p = 0.05 ) when 122 patients with oestrogen-receptor-negative disease were excluded .\
CONCLUSIONS	Our results suggest that early improvements in disease-free survival noted in patients who switch to exemestane after 2-3 years on tamoxifen persist after treatment , and translate into a modest improvement in overall survival .\
\
###8773292\
BACKGROUND	Fluvoxamine , a selective serotonin reuptake inhibitor ( SSRI ) , is used to treat depression .\
BACKGROUND	No significant effect on the electrocardiogram ( ECG ) has been reported during short-term controlled studies of SSRI 's .\
BACKGROUND	We report a long-term ( 1 year ) multi-center , double-blind controlled study of the ECG during treatment of depression with fluvoxamine ( FX ) , active control medication ( TCA ) , and placebo ( PLA ) .\
METHODS	Initially ECGs were obtained from 1840 physically healthy , depressed outpatients who were treated with FX , TCA , or PLA for 6 weeks .\
METHODS	A subset of these patients continued treatment for up to one year .\
METHODS	Complete sets of ECGs were obtained from 462 of these patients .\
METHODS	Patients whose depression was substantially improved in the initial 6-week study ( `` responder '' ) received the same medication .\
METHODS	Non-responders received a blinded active medication .\
METHODS	Pre-treatment , intra-study , and past-treatment ECGs were recorded according to protocol .\
METHODS	One blinded electrocardiographer measured and analyzed all ECG data .\
METHODS	The effects of each medication upon the ECG were measured and compared .\
RESULTS	Of the 462 patients , 311 used FX , 100 used TCA and 51 used PLA .\
RESULTS	Analyses of ECG data for each treatment focused on changes in ECG measurements ; % of normal ECGs , and % of individual ECG findings .\
RESULTS	The ECG changes during FX treatment were less than or not significantly different from the ECG changes with PLA treatment .\
RESULTS	The changes with TCA were as expected .\
CONCLUSIONS	Fluvoxamine treatment of depression for one year was not associated with any significant effect on the ECG .\
\
###17135646\
OBJECTIVE	For patients with small-cell lung cancer ( SCLC ) , further chemotherapy is routinely considered at relapse after first-line therapy .\
OBJECTIVE	However , proof of clinical benefit has not been documented .\
METHODS	This study randomly assigned patients with relapsed SCLC not considered as candidates for standard intravenous therapy to best supportive care ( BSC ) alone ( n = 70 ) or oral topotecan ( 2.3 mg/m2/d , days 1 through 5 , every 21 days ) plus BSC ( topotecan ; n = 71 ) .\
RESULTS	In the intent-to-treat population , survival ( primary end point ) was prolonged in the topotecan group ( log-rank P = .0104 ) .\
RESULTS	Median survival with BSC was 13.9 weeks ( 95 % CI , 11.1 to 18.6 ) and with topotecan , 25.9 weeks ( 95 % CI , 18.3 to 31.6 ) .\
RESULTS	Statistical significance for survival was maintained in a subgroup of patients with a short treatment-free interval ( < or = 60 days ) .\
RESULTS	Response to topotecan was 7 % partial and 44 % stable disease .\
RESULTS	Patients on topotecan had slower quality of life deterioration and greater symptom control .\
RESULTS	Principal toxicities with topotecan were hematological : grade 4 neutropenia , 33 % ; grade 4 thrombocytopenia , 7 % ; and grade 3/4 anemia , 25 % .\
RESULTS	Comparing topotecan with BSC , infection grade 2 was 14 % versus 12 % and sepsis 4 % versus 1 % ; other grade 3/4 events included vomiting 3 % versus 0 , diarrhea 6 % versus 0 , dyspnea 3 % versus 9 % , and pain 3 % versus 6 % .\
RESULTS	Toxic deaths occurred in four patients ( 6 % ) in the topotecan arm .\
RESULTS	All cause mortality within 30 days of random assignment was 13 % on BSC and 7 % on topotecan .\
CONCLUSIONS	Chemotherapy with oral topotecan is associated with prolongation of survival and quality of life benefit in patients with relapsed SCLC .\
\
###11479511\
BACKGROUND	The bioactive peptide endothelin-1 is elevated during and after cardiopulmonary bypass and exerts cardiovascular effects through its 2 receptor subtypes , endothelin-1A and endothelin-1B .\
BACKGROUND	Increased endothelin-1A receptor stimulation after cardiopulmonary bypass can cause increased pulmonary vascular resistance and modulate myocardial contractility .\
BACKGROUND	However , whether and to what degree selective endothelin-1A blockade influences these parameters in the postbypass setting is not completely understood .\
OBJECTIVE	Our objective was to measure left ventricular function and hemodynamics in a porcine model of cardiopulmonary bypass after selective blockade of endothelin-1A .\
METHODS	Adult pigs ( n = 23 ) underwent 90 minutes of cardiopulmonary bypass and were randomized 30 minutes after bypass to receive a selective endothelin-1A antagonist ( TBC 11251 , 10 mg/kg ; n = 13 ) or saline vehicle ( n = 10 ) .\
RESULTS	After bypass and before randomization , pulmonary vascular resistance rose nearly 4-fold , and left ventricular preload recruitable stroke work fell to one third of baseline values ( both P < .05 ) .\
RESULTS	In the vehicle group pulmonary vascular resistance continued to rise , and preload recruitable stroke work remained reduced .\
RESULTS	However , after endothelin-1A blockade , the rise in pulmonary vascular resistance was significantly blunted compared with that in the vehicle group .\
RESULTS	Moreover , the reduction in pulmonary vascular resistance with endothelin-1A blockade was achieved without a significant change in systemic perfusion pressures .\
CONCLUSIONS	The present study demonstrated that increased activity of the endothelin-1A receptor likely contributes to alterations in pulmonary vascular resistance in the postbypass setting .\
CONCLUSIONS	Selective endothelin-1A blockade may provide a means to selectively decrease pulmonary vascular resistance without significant effects on systemic hemodynamics .\
\
###17461981\
BACKGROUND	Recent trials in acute myocardial infarction indicate that intensive and early statin therapy that lowers low-density lipoprotein cholesterol ( LDL-C ) to < or = 70 mg dL ( -1 ) is beneficial .\
BACKGROUND	The combination of statins with ezetimibe , a newly developed cholesterol-absorption inhibitor , can lead to a further reduction in LDL-C of up to 26 % .\
BACKGROUND	In this study , we examined the rapidity and intensity of the lipid-lowering effect of ezetimibe co-administered with simvastatin immediately after myocardial infarction .\
METHODS	Sixty patients admitted for acute myocardial infarction were randomized to receive either simvastatin 40 mg ( SIMVA ) , a combination of simvastatin 40 mg and ezetimibe 10 mg ( EZE/SIMVA ) , or no lipid-lowering drugs ( NLLD ) and had their lipid levels assessed 2 , 4 and 7 days later .\
RESULTS	At baseline , cardiovascular risk factors were similar in all three groups [ mean ( SD ) LDL-C of 141 ( 36 ) mg dL ( -1 ) ] .\
RESULTS	At days 2 , 4 and 7 there was no significant change in mean LDL-C levels in the NLLD group ( -10 % , -6 % , and -9 % , all P > 0.09 ) , while there were significant reductions with SIMVA ( -15 % , -27 % , and -25 % , respectively , all P < 0.001 vs. day 0 ) and even greater reductions with co-administration of EZE/SIMVA ( -27 % , -41 % , and -51 % , respectively , all P < 0.001 vs. day 0 ) .\
RESULTS	The percentages of patients achieving LDL-C below 70 mg dL ( -1 ) at days 4 and 7 were substantially greater with EZE/SIMVA ( 45 % and 55 % , respectively ) than with SIMVA ( 5 % and 10 % , respectively ) , while no NLLD patient reached this goal .\
RESULTS	Triglyceride levels showed a progressive increase in the NLLD group ( +45 % at day 7 , P < 0.05 vs. day 0 ) , no change in the SIMVA group , but a decrease in the EZE/SIMVA group ( -17 % at day 7 , P < 0.05 vs. day 0 ) .\
RESULTS	No significant difference in HDL-C levels , tolerability , or clinical events was observed between the three groups .\
CONCLUSIONS	The co-administration of ezetimibe 10 mg with simvastatin 40 mg , by inhibiting cholesterol absorption and production , allowed more patients with acute myocardial infarction to reach LDL-C < or = 70 mg dL ( -1 ) as early as the fourth day of treatment .\
CONCLUSIONS	The effects of such rapid and intense reduction in LDL-C on cardiovascular morbidity and mortality need to be evaluated in future clinical endpoint studies .\
\
###19682360\
BACKGROUND	The objective of this research was to evaluate data from a randomized clinical trial that tested injectable diacetylmorphine ( DAM ) and oral methadone ( MMT ) for substitution treatment , using a multi-domain dichotomous index , with a Bayesian approach .\
METHODS	Sixty two long-term , socially-excluded heroin injectors , not benefiting from available treatments were randomized to receive either DAM or MMT for 9 months in Granada , Spain .\
METHODS	Completers were 44 and data at the end of the study period was obtained for 50 .\
METHODS	Participants were determined to be responders or non responders using a multi-domain outcome index accounting for their physical and mental health and psychosocial integration , used in a previous trial .\
METHODS	Data was analyzed with Bayesian methods , using information from a similar study conducted in The Netherlands to select a priori distributions .\
METHODS	On adding the data from the present study to update the a priori information , the distribution of the difference in response rates were obtained and used to build credibility intervals and relevant probability computations .\
RESULTS	In the experimental group ( n = 27 ) , the rate of responders to treatment was 70.4 % ( 95 % CI 53.287.6 ) , and in the control group ( n = 23 ) , it was 34.8 % ( 95 % CI 15.354.3 ) .\
RESULTS	The probability of success in the experimental group using the a posteriori distributions was higher after a proper sensitivity analysis .\
RESULTS	Almost the whole distribution of the rates difference ( the one for diacetylmorphine minus methadone ) was located to the right of the zero , indicating the superiority of the experimental treatment .\
CONCLUSIONS	The present analysis suggests a clinical superiority of injectable diacetylmorphine compared to oral methadone in the treatment of severely affected heroin injectors not benefiting sufficiently from the available treatments .\
BACKGROUND	Current Controlled Trials ISRCTN52023186 .\
\
###18373281\
BACKGROUND	The harmful effects of ischaemia-reperfusion on skeletal muscle during extremity surgery can be diminished by using medications or ischaemic preconditioning\
METHODS	Twenty patients undergoing lower-limb surgery with use of a tourniquet for at least 1 hour were included in the study and randomised into two groups : a control group with only tourniquet application ( T group ; n = 10 ) ; and an ischaemic preconditioning plus tourniquet group ( IP-T group ; n = 10 ) .\
METHODS	Blood samples were obtained from the femoral vein of the relevant extremity before tourniquet application ( baseline ) , immediately after tourniquet deflation ( TD ) , at 10 minutes after the tourniquet deflation ( TD ( 10min ) ) in the T group and additionally after ischaemic preconditioning in the IP-T group .\
METHODS	Venous blood pH , partial oxygen pressure ( P ( vO2 ) ) , partial carbon dioxide pressure ( P ( vCO2 ) ) , lactate , potassium , sodium and glucose levels were analysed using a blood gas analyser .\
METHODS	Plasma thiobarbituric acid reactive substances ( TBARS ) level , an index of lipid peroxidation and oxidative stress , was measured .\
METHODS	Heart rate , noninvasive mean arterial pressure ( MAP ) and spontaneous breathing rate ( SBR ) were recorded at baseline , at TD , and TD ( 1min ) , TD ( 5min ) and TD ( 10min ) .\
RESULTS	MAP decreased and SBR increased significantly at TD , TD ( 1min ) and TD ( 5min ) compared with baseline , and venous blood TBARS level significantly increased at TD and TD ( 10min ) compared with baseline in the T group ( all P < 0.05 ) .\
RESULTS	No significant changes were observed in the IP-T group .\
RESULTS	Ischaemic preconditioning caused a rise in PvO2 and a decrease in venous blood pH , P ( vCO2 ) , and lactate levels , which was significant compared with baseline ( P < 0.05 )\
CONCLUSIONS	Ischaemic preconditioning attenuates haemodynamic response and lipid peroxidation during lower-extremity surgery with unilateral tourniquet application .\
\
###21283919\
OBJECTIVE	To compare the functional stability of Cetaphil UVA/UVB Defense SPF 50 as measured by its ultraviolet B sun protection factor ( UVB-SPF ) and ultraviolet A protection factor ( UVA-PF ) values following exposure to natural sunlight versus the UVB-SPF and UVA-PF values of unexposed product .\
METHODS	These two randomized , controlled , evaluator-blinded , single-center trials were conducted according to the methods outlined in the 2007 Proposed Amendment to the Final Monograph , Sunscreen Drug Products for Over-the-Counter Human Use .\
METHODS	Sunscreen samples were applied to glass plates and exposed to ultraviolet radiation in the form of natural sunlight in four minimal erythemal doses ( MED ) ranging from 26 MED ( 4236 mJ/cm2 ) .\
METHODS	Three test sites were identified on the back of each study subject .\
METHODS	Exposed sunscreen ( one of four doses ) , unexposed sunscreen , and a UVB-SPF 15 control sunscreen were applied to the three test sites in a randomized fashion , followed by UV irradiation of incremental doses .\
METHODS	Erythema and pigment darkening responses were assessed immediately following UV exposure and again 1624 hours ( erythema ) or three to 24 hours ( pigment darkening ) after exposure .\
METHODS	UVB-SPF and UVA-PF values were calculated for the exposed and unexposed samples .\
RESULTS	The calculated UVB-SPF and UVA-PF values for all test samples ( exposed and unexposed ) were > 50 and > 9 , respectively , which were greater than the stated UVB-SPF and UVA-PF values on the product label .\
RESULTS	No differences were observed between the exposed and unexposed samples in UVB-SPF or UVA-PF .\
CONCLUSIONS	The UVA and UVB protection using standard evaluation techniques of Cetaphil UVA/UVB Defense SPF 50 remains stable despite exposure of the sunscreen to natural sunlight containing UVB ranging from 216 MED ( 41336 mJ/cm2 ) and coexistent UVA .\
\
###21205302\
BACKGROUND	Pregnant women living with HIV ( WLH ) face daily challenges maintaining their own and their babies ' health and mental health .\
BACKGROUND	Standard Prevention of Maternal to Child Transmission ( PMTCT ) programs are not designed to address these challenges .\
METHODS	As part of a cluster randomized controlled trial , WLH are invited to attend four antenatal and four postnatal small group sessions led by a peer WLH ( a Peer Mentor ) .\
METHODS	The WLH and their babies are assessed during pregnancy and at one week , six months , and twelve months post-birth .\
METHODS	Mobile phones are used to collect routine information , complete questionnaires and remain in contact with participants over time .\
METHODS	Pregnant WLH ( N = 1200 ) are randomly assigned by clinic ( N = 8 clinics ) to an intervention program , called Masihambisane ( n = 4 clinics , n = 600 WLH ) or a standard care PMTCT control condition ( n = 4 clinics ; n = 600 WLH ) .\
CONCLUSIONS	Data collection with cellular phones are innovative and effective in low-resource settings .\
CONCLUSIONS	Standard PMTCT programs are not designed to address the daily challenges faced by WLH ; Peer Mentors may be useful in supporting WLH to cope with these challenges .\
BACKGROUND	ClinicalTrials.gov registration # NCT00972699 .\
\
###9863122\
OBJECTIVE	To explore the therapeutic effect and its mechanism mainly using traditional Chinese medicine ( TCM ) of replenishing Qi and nourishing Yin ( RQNY ) with a small dosage of Tapazol for treatment of Graves disease ( GD ) .\
METHODS	The changes of thyroid function and the activity of sodium pump of human erythrocyte in the patients with Graves disease were observed and compared before and after treatment between the treated group ( 42 cases ) by combining treatment mainly using TCM of RQNY and a small amount of Tapazol , and a control group ( 42 cases ) by Tapazol alone .\
RESULTS	After treatment for half a year , one and two years , the serum levels of T3 , T4 in above two groups were markedly decreased than those of before treatment , the therapeutical effect of treated group was superior to that of control group .\
RESULTS	The activity of sodium pump in human erythrocyte in the GD patients was obviously higher than that of normal group and that of before treatment .\
RESULTS	After treatment for one and two years mainly by TCM or Western medicine , the erythrocyte sodium pump activity was obviously lower than that of before treatment and that of normal group .\
RESULTS	The decrease of erythrocyte sodium pump activity in group of combination therapy was markedly lower than that in group of Western medicine .\
CONCLUSIONS	Combination therapy was much more effective on the functional remission of thyroid and energy metabolism in GD patients than that of using Tapazol therapy only .\
\
###24807502\
OBJECTIVE	Bladder pain syndrome/interstitial cystitis ( BPS/IC ) is a chronic disease that highly degrades the quality of life for patients .\
OBJECTIVE	In the present study , Internet intervention was used to care for bladder pain syndrome/interstitial cystitis patients to alleviate their pain and bothering symptoms .\
METHODS	Healthcare education was carried out through the Internet by asking the patients , who were randomly divided into study ( 40 patients ) and control ( 40 patients ) groups , to check possible sensitive foods , habits , and behaviors weekly to remind and consolidate important rules for promoting quality of life .\
METHODS	The symptom flares consultation through short message service with the Internet used to elevate healthcare efficiency was undertaken .\
METHODS	Questionnaires , including Short Form 36 health survey , O'Leary-Sant symptom and problem indices , as well as visual analog scales pain and urgency scales , were used to evaluate quality of life and disease severity improvements before and after information and communication technology intervention .\
METHODS	The outcome was evaluated at week 8 .\
RESULTS	The quality of life of both the control and study groups was significantly improved .\
RESULTS	The quality of life and visual analog scales for the patients in the study group with information and communication technology intervention showed a much greater improvement compared with the patients in the control group ( P < 0.05 ) .\
CONCLUSIONS	The E-health system was shown to be effective in improving quality of life of bladder pain syndrome/interstitial cystitis patients through intervention of Internet healthcare education and short message service for the consolidation of healthy behavior and lifestyle in the 8-week follow up .\
\
###9866667\
BACKGROUND	Topical antimicrobials have been considered for treatment of secondarily infected wounds because of the potential for reduced risk of adverse effects and greater patient convenience .\
BACKGROUND	We compared mupirocin cream with oral cephalexin in the treatment of wounds such as small lacerations , abrasions , or sutured wounds .\
METHODS	In 2 identical randomized double-blind studies , 706 patients with secondarily infected wounds ( small lacerations , abrasions , or sutured wounds ) received either mupirocin cream topically 3 times daily or cephalexin orally 4 times daily for 10 days .\
RESULTS	Clinical success at follow-up was equivalent in the two groups : 95.1 % and 95.3 % in the mupirocin cream and the cephalexin groups , respectively ( 95 % confidence interval [ CI ] , -4.0 % to 3.6 % ; P = .89 ) .\
RESULTS	The intention-to-treat success rate was 83 % in both groups .\
RESULTS	Bacteriologic success at follow-up was also comparable : 96.9 % in the mupirocin cream and 98.9 % in the cephalexin groups ( 95 % CI , -6.0 % to 2.0 % ; P = .22 ) .\
RESULTS	The occurrence of adverse experiences related to study treatment was similar for the 2 groups , with fewer patients in the mupirocin cream group reporting diarrhea ( 1.1 % vs 2.3 % for cephalexin ) .\
CONCLUSIONS	Mupirocin cream applied topically 3 times daily is as effective as oral cephalexin given 4 times daily for the treatment of secondarily infected wounds and was well tolerated .\
\
###16170976\
OBJECTIVE	This single-blind , five parallel-arm , four-week randomized clinical trial was designed to compare the efficacy of a 0.05 % cetylpyridinium chloride gel-releasing interdental brush ( IDB ) with standard interproximal cleaning devices for plaque and gingivitis reduction , and decreased frequency in interproximal gingival bleeding .\
METHODS	After consenting , participants meeting inclusion criteria brushed their teeth , received a baseline examination and a professional cleaning , and were then block-randomized into five groups , with the plaque level serving as the blocking variable .\
METHODS	All five groups performed standard tooth brushing as a background regimen .\
METHODS	Three of the groups were respectively assigned to one of three interdental brush regimens , the fourth group was assigned to a standard flossing regimen ( positive control ) , and the fifth group was assigned to a standard tooth brushing only regimen ( control ) .\
METHODS	Clinical outcome data were collected at two and four weeks .\
RESULTS	Of a total of 162 starting participants , 152 completed the study .\
RESULTS	There were no baseline differences among the five groups with respect to age , interproximal plaque score , interproximal gingivitis score , or percent of interproximal bleeding on probing .\
RESULTS	After two and four weeks , the 3 IDB groups exhibited 30-40 percent lower plaque levels than the control ( p < 0.05 ) .\
RESULTS	With respect to interproximal gingival scores , the active agent IDB group exhibited a statistically significant effect after two weeks , and all three IDB groups demonstrated significantly better outcomes after four weeks ( p < 0.05 ) .\
RESULTS	At two and four weeks , the three IDB groups demonstrated a greater reduction in interproximal bleeding points upon probing compared to the two control groups ( p < 0.05 ) .\
RESULTS	The group using the 0.05 % cetylpyridinium gel-releasing IDB system did not demonstrate superior clinical results when compared to the two other IDB groups .\
CONCLUSIONS	When compared to control and positive control interdental cleaning procedures , daily use of IDBs was effective in reducing interproximal plaque and gingivitis scores , as well as interproximal bleeding on probing .\
CONCLUSIONS	The benefits were evident at two weeks , but were more consistent after four weeks .\
CONCLUSIONS	The 0.05 % cetylpyridinium gel-releasing IDB system did not appear to confer a consistently independent incremental benefit .\
\
###22853818\
BACKGROUND	Severe malaria results in over a million deaths every year , most of them in children aged less than five years and living in sub-Saharan Africa .\
BACKGROUND	Injectable artesunate ( AS ) was recommended as initial treatment for severe malaria by WHO in 2006 .\
BACKGROUND	The Walter Reed Army Institute of Research ( WRAIR ) has been developing a novel good manufacturing practice ( GMP ) injection of AS , which was approved by the US FDA for investigational drug use and distribution by the CDC .\
METHODS	Tolerability and pharmacokinetics of current GMP intravenous AS , as an anti-malarial agent , were evaluated after ascending multiple doses of 2 , 4 , and 8 mg/kg daily for three days with 2-minute infusion in 24 healthy subjects ( divided into three groups ) in the Phase 1 clinical trial study .\
RESULTS	Results showed that there were no dose-dependent increases in any adverse events .\
RESULTS	Drug concentrations showed no accumulation and no decline of the drug during the three days of treatment .\
RESULTS	After intravenous injection , parent drug rapidly declined and was converted to dihydroartemisinin ( DHA ) with overall mean elimination half-lives ranging 0.15-0 .23 hr for AS and 1.23-1 .63 hr for DHA , but the peak concentration ( C ( max ) ) of AS was much higher than that of DHA with a range of 3.08-3 .78 - folds .\
RESULTS	In addition , the AUC and C ( max ) values of AS and DHA were increased proportionally to the AS climbing multiple doses .\
CONCLUSIONS	The safety of injectable AS , even at the highest dose of 8 mg/kg increases the probability of therapeutic success of the drug even in patients with large variability of parasitaemia .\
\
###15454616\
OBJECTIVE	To prospectively test the hypothesis that high levels of the fraction of inspired oxygen ( Fio ( 2 ) ) during general anesthesia cause subarachnoid cerebrospinal fluid ( CSF ) hyperintensity during fluid-attenuated inversion-recovery ( FLAIR ) magnetic resonance ( MR ) imaging .\
METHODS	At brain MR imaging during general anesthesia with propofol , two FLAIR sequences were performed in 20 children with American Society of Anesthesiologists physical status classification system grades of 3 or lower .\
METHODS	The first FLAIR sequence was performed with the child breathing 100 % oxygen ; the second was performed with the child breathing 30 % oxygen .\
METHODS	CSF signal intensity was quantified on a three-point ordinal scale ( 0 = hypointense to brain parenchyma , 1 = isointense to brain parenchyma , 2 = hyperintense to brain parenchyma ) by a pediatric neuroradiologist who was blinded to the Fio ( 2 ) level .\
METHODS	The Wilcoxon signed rank test was used to determine if CSF hyperintensity was correlated with Fio ( 2 ) .\
RESULTS	CSF hyperintensity was present in all 20 children ( age range , 1.9-16 .7 years ; 12 children were boys ) when the Fio ( 2 ) was 100 % .\
RESULTS	The hyperintensity partially or completely disappeared in the basilar cisterns ( P < .001 ) and cerebral sulcal subarachnoid space ( P < .001 ) after Fio ( 2 ) was reduced from 100 % to 30 % .\
CONCLUSIONS	These findings are consistent with the hypothesis that increased arterial oxygen tension and consequently increased CSF Po ( 2 ) resulting from administration of high Fio ( 2 ) during general anesthesia are responsible for the increased CSF signal intensity noted on brain FLAIR MR images .\
\
###19916693\
OBJECTIVE	Immobilization in external rotation ( ER ) for shoulder dislocation has been reported to improve the coaptation of Bankart lesions to the glenoid .\
OBJECTIVE	We compared the position of the labrum in patients treated with immobilization in ER or internal rotation ( IR ) .\
OBJECTIVE	A secondary aim was to evaluate the rate of Bankart lesions .\
METHODS	55 patients with primary anterior shoulder dislocation , aged between 16 and 40 years , were randomized to immobilization in ER or IR .\
METHODS	Computer tomography ( CT ) and magnetic resonance imaging ( MRI ) were performed shortly after the injury .\
METHODS	After the immobilization , MRI arthrography was performed .\
METHODS	We evaluated the rate of Bankart lesions and measured the separation and displacement of the labrum as well as the length of the detached part of the capsule on the glenoid neck .\
RESULTS	Immobilization in ER reduced the number of Bankart lesions ( OR = 3.8 , 95 % CI : 1.1 -13 ; p = 0.04 ) .\
RESULTS	Separation decreased to a larger extent in the ER group than in the IR group ( mean difference 0.6 mm , 95 % CI : 0.1 - 1.1 , p = 0.03 ) .\
RESULTS	Displacement of the labrum and the detached part of the capsule showed no significant differences between the groups .\
CONCLUSIONS	Immobilization in ER results in improved coaptation of the labrum after primary traumatic shoulder dislocation .\
\
###22194183\
BACKGROUND	Antidepressant prescribing is widespread .\
BACKGROUND	Nonetheless , response to antidepressants is variable .\
BACKGROUND	If it was possible to predict response to medication and thus tailor treatment accordingly , this would not only improve patient outcomes but may also have economic benefits .\
OBJECTIVE	To test the hypothesis that individuals with more severe depression would benefit more from noradrenaline reuptake inhibitors ( NARIs ) than selective serotonin reuptake inhibitors ( SSRIs ) compared with individuals with less severe depression .\
METHODS	Individuals recruited from UK primary care who met ICD-10 criteria for a depressive episode and scored 15 or more on the Beck Depression Inventory ( BDI ) were randomised to either an SSRI ( citalopram 20 mg daily ) or a NARI ( reboxetine 4 mg twice daily ) .\
METHODS	Randomisation was by means of a remote automated telephone system .\
METHODS	The main outcome was depressive symptoms measured by the BDI total score 6 weeks after randomisation .\
BACKGROUND	ISRCTN31345163 . )\
RESULTS	In total , 601 participants were randomised ( citalopram : n = 298 , reboxetine : n = 303 ) .\
RESULTS	Ninety-one per cent were followed up at 6 weeks ( citalopram : n = 274 , reboxetine : n = 272 ) .\
RESULTS	There was little evidence to support an interaction between treatment and severity of depression ( interaction term : 0.02 , 95 % CI -0.59 to 0.62 , P = 0.96 ) .\
RESULTS	Adjustment for potential confounders ( age , gender , employment status , history of depression , number of life events and social support ) did not affect the findings ( interaction term : 0.06 , 95 % CI -0.54 to 0.66 , P = 0.85 ) .\
CONCLUSIONS	Treatment with NARIs does not confer any advantage over SSRI treatment for outcome in those with more severe depressive illness presenting in primary care .\
\
###21552185\
BACKGROUND	The effect of early versus deferred antiretroviral treatment ( ART ) on plasma concentration of lipopolysaccharide ( LPS ) and host LPS-binding molecules in human immunodeficiency virus ( HIV ) - infected infants up to 1 year of age was investigated .\
METHODS	We evaluated 54 perinatally HIV-infected and 22 HIV-exposed uninfected infants ( controls ) at the first and second semester of life .\
METHODS	All HIV-infected infants had a baseline CD4 of 25 % , participated in the Comprehensive International Program of Research on AIDS Children with HIV Early Antiretroviral Therapy trial in South Africa , and were randomized in the following groups : group 1 ( n = 20 ) , ART deferred until CD4 < 25 % or severe HIV disease ; and group 2 ( n = 34 ) , ART initiation within 6 to 12 weeks of age .\
METHODS	LPS , endotoxin-core antibodies , soluble CD14 ( sCD14 ) , and LPS-binding protein ( LBP ) were measured in cryopreserved plasma .\
METHODS	T-cell activation was measured in fresh whole blood .\
RESULTS	At the first semester , LPS concentration was higher in HIV-infected infants than in controls ; sCD14 , LBP , and T-cell activation were higher in group 1 than in group 2 and controls .\
RESULTS	Although LPS was not correlated with study variables , viral load was positively associated with sCD14 , LBP , or endotoxin-core antibodies .\
RESULTS	At the second semester , LPS was not detectable and elevated host LPS-control molecules values were sustained in all groups and in conjunction with ART in all HIV-infected infants .\
CONCLUSIONS	Although plasma concentration of LPS was higher in perinatally HIV-infected infants 0 to 6 months of age than in controls independent of ART initiation strategy , concentration of LPS-control molecules was higher in infants with deferred ART , suggesting the presence of increased microbial translocation in HIV-infected infants with sustained early viral replication .\
\
###21301830\
OBJECTIVE	Hemiarthroplasty ( HA ) is generally considered to be the treatment of choice in the most elderly patients with a displaced fracture of the femoral neck .\
OBJECTIVE	However , there is inadequate evidence to support the choice between unipolar HA or bipolar HA .\
OBJECTIVE	The primary aim of this study was to analyse the outcome regarding hip function and health-related quality of life ( HRQoL ) in patients randomised to either a unipolar or bipolar HA .\
OBJECTIVE	The secondary aim was to analyse the degree of acetabular erosion and its influence upon outcome .\
METHODS	One hundred twenty patients with a mean age of 86 years and an acute displaced fracture of the femoral neck were randomly allocated to treatment by either unipolar or bipolar HA .\
METHODS	Outcome measurements included hip function ( Harris Hip Score , HHS ) , HRQoL ( EQ-5D ) and acetabular erosion .\
METHODS	The patients were summoned at four and 12 months for follow-up .\
RESULTS	There were no significant differences between the groups regarding complications .\
RESULTS	The HHS scores were equal at both follow-ups , but there was a trend towards better HRQoL in the bipolar HA group at four months , EQ-5D ( index ) score 0.62 vs 0.54 ( p = 0.06 ) .\
RESULTS	Twenty percent of the patients in the unipolar HA group displayed acetabular erosion at the 12-month follow-up compared to 5 % in the bipolar HA group ( p = 0.03 ) , and there were trends towards worse hip function and HRQoL among patients with acetabular erosion compared to those without : HHS scores 70.4 and 79.3 , respectively ( p = 0.09 ) , and EQ-5D ( index ) scores 0.48 and 0.63 , respectively ( p = 0.13 ) .\
CONCLUSIONS	Unipolar HA and bipolar HA appeared to produce equivalent clinical outcomes after one year , but the significantly higher incidence of acetabular erosion in the unipolar HA group may imply that bipolar HA should be the preferred treatment .\
\
###23348843\
BACKGROUND	Cigarette smoking can lead to systemic endothelial dysfunction .\
BACKGROUND	Since the airway circulation is exposed to a high concentration of cigarette smoke constituents , we reasoned that airway vascular endothelial dysfunction could be present in healthy smokers without systemic endothelial dysfunction .\
OBJECTIVE	The purpose of this study was to compare airway and systemic endothelial function and measure markers of systemic inflammation in lung-healthy current smokers .\
OBJECTIVE	Since endothelial dysfunction in smokers has been related to systemic inflammation , we also investigated its response to an inhaled glucocorticosteroid ( ICS ) .\
METHODS	Fifteen healthy , current smokers and 17 healthy , lifetime nonsmokers were enrolled .\
METHODS	Smokers were randomly assigned to 3-week treatments with inhaled fluticasone propionate or placebo in a crossover design .\
METHODS	Vascular endothelial function was assessed in the airway by the airway blood-flow response to inhaled albuterol ( Qaw ) and in the extrapulmonary circulation by brachial arterial flow-mediated vasodilation ( FMD ) .\
METHODS	Venous blood was collected for C-reactive protein and IL-6 .\
RESULTS	Baseline parameters did not differ between groups except for Qaw , which was greater in nonsmokers ( 45 % 12 % ) than smokers ( 1 % 12 % ) ( P = .001 ) .\
RESULTS	In the smokers , ICS treatment increased Qaw to 41 % 7 % ( P < .001 ) , but had no effect on FMD or inflammatory markers .\
RESULTS	There was an inverse relationship between baseline and ICS-induced changes in Qaw .\
CONCLUSIONS	Healthy smokers with no signs of systemic inflammation or endothelial dysfunction display impaired airway vascular endothelial function , possibly preceding systemic endothelial dysfunction .\
CONCLUSIONS	Airway endothelial function was restored with an ICS , and the response was directly related to the severity of endothelial dysfunction .\
\
###16426168\
OBJECTIVE	To evaluate signs of postoperative pain and complications after forelimb onychectomy in cats receiving buprenorphine alone or with bupivacaine administered as a 4-point regional nerve block .\
METHODS	Prospective , randomized , double-blind clinical trial .\
METHODS	20 cats .\
METHODS	All cats received buprenorphine ( 0.01 mg/kg [ 0.004 mg/lb ] , IM ) preoperatively .\
METHODS	One forelimb of each cat also received bupivacaine ( 1 mg/kg [ 0.45 mg/lb ] of a 0.75 % solution ) administered as a 4-point regional nerve block .\
METHODS	After onychectomy , discomfort ( lameness , foot reaction , and pain ) scores were evaluated by 2 experienced observers 2 , 4 , 6 , 8 , 24 , and 168 hours postoperatively .\
METHODS	Complication ( hemorrhage , swelling , and infection ) scores were evaluated 24 and 168 hours postoperatively .\
METHODS	Surgeries were performed by 1 experienced veterinary surgeon .\
METHODS	Rescue analgesia was provided if needed .\
RESULTS	6 cats required rescue analgesia postoperatively .\
RESULTS	There was no difference in discomfort or complication scores between control limbs and limbs in which a nerve block was administered .\
RESULTS	Additionally , there was no difference in discomfort and complication scores between cats that did or did not require rescue analgesia .\
CONCLUSIONS	Bupivacaine administered as a 4-point regional nerve block in addition to a systemic analgesic did not decrease discomfort or complication scores in cats undergoing forelimb onychectomy .\
\
###23794320\
OBJECTIVE	To assess the prevalence of adverse drug reactions ( ADRs ) occurring in patients with Alzheimer 's disease ( AD ) or other dementia in France .\
METHODS	A cross-sectional multicentre study was conducted by the French network of the 31 regional pharmacovigilance centres on a given day .\
METHODS	The subjects were selected by random draw to be a representative sample of French patients with dementia : consultations of dementia clinics , nursing-homes , acute and long care geriatric units , rehabilitation care geriatric units .\
METHODS	The staff of each medical structure together with that of the pharmacovigilance centre defined a day for including the patients .\
METHODS	Socio-demographic data , history , ADR and drugs given were registered .\
RESULTS	There were 1332 subjects included , 51.1 % living at home , 48.8 % in institutions , aged 82.08.0 years ( 46-108 ) ; 61.3 % suffered from AD .\
RESULTS	Mean number of drugs was 6.33.1 .\
RESULTS	Anti-dementia drugs were given to 66.4 % subjects .\
RESULTS	ADR prevalence was 5.0 % ( 95 % CI : 3.9-6 .2 ) without a significant difference between at home and institutionalized patients .\
RESULTS	ADR consisted of gastro-intestinal ( 23.2 % ) , central nervous system ( 17.4 % ) and psychiatric disorders ( 8.7 % ) .\
RESULTS	Of the ADR , 31.9 % were serious , and 47.8 % preventable .\
RESULTS	The drugs most often involved were anti-dementia ( 28.9 % ) , cardio-vascular ( 28.9 % ) and psychotropic drugs ( 26.4 % , anxiolytics , hypnotics , antidepressants , neuroleptics ) .\
CONCLUSIONS	This national scale study showed that iatrogenesis in patients with AD and related dementia can at times be serious and preventable .\
CONCLUSIONS	Therefore , special attention is required when prescribing psychotropic and anti-dementia drugs , as they are frequently used and induce half of the ADR in this population .\
\
###9163286\
BACKGROUND	Hemorrhage from esophageal varices remains a substantial management problem .\
BACKGROUND	Endoscopic sclerotherapy was preferred for more than a decade , but fluoroscopically placed intrahepatic portosystemic stents have recently been used with increasing frequency .\
OBJECTIVE	To compare sclerotherapy with transjugular intrahepatic portosystemic shunt ( TIPS ) in patients with bleeding from esophageal varices .\
METHODS	Randomized , controlled clinical trial .\
METHODS	Three teaching hospitals .\
METHODS	49 adults hospitalized with acute variceal hemorrhage from November 1991 to December 1995 : 25 assigned to sclerotherapy and 24 assigned to TIPS .\
METHODS	Patients assigned to repeated sclerotherapy had the procedure weekly .\
METHODS	In those assigned to TIPS , an expandable mesh stent was fluoroscopically placed between an intrahepatic portal vein and an adjacent hepatic vein .\
METHODS	Pretreatment measures included demographic and laboratory data .\
METHODS	Postrandomization data included index hospitalization survival , duration of follow-up , successful obliteration of varices , rebleeding from varices , number of variceal rebleeding events , total days of hospitalization for variceal bleeding , blood transfusion requirements after randomization , prevalence of encephalopathy , and total health care costs .\
RESULTS	Mean follow-up ( + / - SE ) was 567 + / - 104 days in the sclerotherapy group and 575 + / - 109 days in the TIPS group .\
RESULTS	Varices were obliterated more reliably by TIPS than by sclerotherapy ( P < 0.001 ) .\
RESULTS	Patients having TIPS were significantly less likely to rebleed from esophageal varices than patients receiving sclerotherapy ( 3 of 24 compared with 12 of 25 ; P = 0.012 ) .\
RESULTS	No other follow-up measures differed significantly between groups .\
RESULTS	A trend toward improved survival , which was not statistically significant , was noted in the TIPS group ( hazard ratio , 0.53 [ 95 % CI , 0.18 to 1.5 ] ) .\
CONCLUSIONS	In obliterating varices and reducing rebleeding events from esophageal varies , TIPS was more effective than sclerotherapy .\
CONCLUSIONS	However , TIPS did not decrease morbidity after randomization or improve health care costs .\
CONCLUSIONS	It seemed to produce better survival , but the increase in survival was not statistically significant .\
\
###12056851\
BACKGROUND	The Western Ontario and McMaster Universities ( WOMAC ) Osteoarthritis Index is a previously described self-administered questionnaire covering three domains : pain , stiffness and function .\
BACKGROUND	It has been validated in patients with osteoarthritis ( OA ) of the hip or knee in a paper-based format .\
OBJECTIVE	To validate the WOMAC 3.0 using a numerical rating scale in a computerized touch screen format allowing immediate evaluation of the questionnaire .\
OBJECTIVE	In the computed version cartoons , written and audio instruments were included in order facilitate application .\
METHODS	Fifty patients , demographically balanced , with radiographically proven primary hip or knee OA completed the classical paper and the new computerized WOMAC version .\
METHODS	Subjects were randomized either to paper format or computerized format first to balance possible order effects .\
RESULTS	The intra-class correlation coefficients for pain , stiffness and function values were 0.915 , 0.745 and 0.940 , respectively .\
RESULTS	The Spearman correlation coefficients for pain , stiffness and function were 0.88 , 0.77 and 0.87 , respectively .\
CONCLUSIONS	These data indicate that the computerized WOMAC OA index 3.0 is comparable to the paper WOMAC in all three dimensions .\
CONCLUSIONS	The computerized version would allow physicians to get an immediate result and if present a direct comparison with a previous exam .\
\
###15598481\
BACKGROUND	Seirogan , an herbal medication containing wood creosote , a mixture of simple phenolic ( single-ring ) compounds , has been marketed in Asia for the past century as an antidiarrheal and antispasmodic medication .\
BACKGROUND	This was the first randomized , double-blind study of this herbal medication in patients with acute , nonspecific diarrhea .\
OBJECTIVE	The aim of this study was to compare the efficacy and tolerability of wood creosote with those of loperamide hydrochloride in patients with acute , nonspecific diarrhea .\
METHODS	This double-blind , randomized , active-controlled study was conducted at 12 centers across the United States and Mexico .\
METHODS	Patients aged > or = 18 years with acute , nonspecific diarrhea , defined as a history of diarrhea for < or = 72 hours and passage of > or = 3 unformed stools in the 24 hours before the study , accompanied by > or = 1 associated symptom ( ie , nausea , vomiting , abdominal cramping , and/or fever [ < or = 101.0 degrees F or < or = 38.3 degrees C ] ) , were eligible for the study Patients received wood creosote 135 mg ( < or = 5 doses/d ) or loperamide 4 mg ( loading dose ) followed by 2 mg ( < or = 8 mg/d ) after each loose stool for < or = 3 days .\
METHODS	The primary efficacy end point was the time to the last unformed stool ( TTLUS ) .\
METHODS	Clinical safety laboratory tests and patient diaries were used to assess tolerability .\
RESULTS	One hundred twenty-three patients ( 74 women , 49 men ; mean [ SD ] age , 42.6 [ 14.9 ] years ; age range , 18-90 years ) were randomized to receive wood creosote ( n = 60 ) or loperamide ( n = 63 ) .\
RESULTS	Eighty-four of the 123 enrolled patients ( 68.3 % ) were Hispanic , 18 ( 14.6 % ) white , 17 ( 13.8 % ) black , and 4 ( 3.3 % ) Asian or Pacific Islander .\
RESULTS	The majority of patients ( 88.3 % in the wood creosote group and 95.2 % in the loperamide group ) had abdominal cramping as the predominant associated symptom .\
RESULTS	The median ( interquartile range [ IQR ] ) TTLUS was similar between groups ( 24.4 [ 6.3-36 .8 ] and 22.1 [ 3.5-32 .1 ] hours in the wood creosote and loperamide groups , respectively ) , as was the median ( IQR ) time to total relief ( 31.0 [ 15.7-47 .8 ] and 28.5 [ 13.5-43 .5 ] hours in the wood creosote and loperamide groups , respectively ) .\
RESULTS	The mean ( SD ) numbers of unformed stools on day 1 were 3.31 ( 2.15 ) and 2.22 ( 1.25 ) in the wood creosote and loperamide groups , respectively ( P < 0.002 ) .\
RESULTS	The percentages of patients with improved or resolved abdominal cramping at the end of day 1 were 92.5 % ( 49/53 ) and 78.0 % ( 46/59 ) in the wood creosote and loperamide groups , respectively ( P < 0.038 ) .\
RESULTS	Both medications were well tolerated in the population studied .\
CONCLUSIONS	Wood creosote and loperamide had comparable antidiarrheal effects in these patients with acute , nonspecific diarrhea .\
CONCLUSIONS	Wood creosote appeared somewhat more efficacious in improving or resolving abdominal cramping , whereas loperamide appeared somewhat more efficacious in improving diarrhea .\
CONCLUSIONS	Both treatments were well tolerated .\
\
###10178617\
OBJECTIVE	This study compares the efficacy of a self-help intervention tailored to the individual 's stage of motivational readiness for exercise adoption with a standard self-help exercise promotion intervention .\
METHODS	Interventions were delivered at baseline and 1 month ; assessments were collected at baseline and 3 months .\
METHODS	Eleven worksites participating in the Working Healthy Research Trial .\
METHODS	Participants ( n = 1559 ) were a subsample of employees at participating worksites , individually randomized to one of two treatment conditions .\
METHODS	Printed self-help exercise promotion materials either ( 1 ) matched to the individual 's stage of motivational readiness for exercise adoption ( motivationally tailored ) , or ( 2 ) standard materials ( standard ) .\
METHODS	Measures of stage of motivational readiness for exercise and items from the 7-Day Physical Activity Recall .\
RESULTS	Among intervention completers ( n = 903 ) , chi-square analyses showed that , compared to the standard intervention , those receiving the motivationally tailored intervention were significantly more likely to show increases ( 37 % vs. 27 % ) and less likely to show either no change ( 52 % vs. 58 % ) or regression ( 11 % vs. 15 % ) in stage of motivational readiness .\
RESULTS	Multivariate analyses of variance showed that changes in stage of motivational readiness were significantly associated with changes in self-reported time spent in exercise .\
CONCLUSIONS	This is the first prospective , randomized , controlled trial demonstrating the efficacy of a brief motivationally tailored intervention compared to a standard self-help intervention for exercise adoption .\
CONCLUSIONS	These findings appear to support treatment approaches that tailor interventions to the individual 's stage of motivational readiness for exercise adoption .\
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###8728664\
OBJECTIVE	This study compared soft versus hard resting hand splints on pain and hand function in 39 persons with rheumatoid arthritis .\
OBJECTIVE	Splint preference was also evaluated to determine its effects on splint wear compliance .\
METHODS	A repeated measures research design was used to compare the two experimental conditions , wearing a soft splint versus a hard splint on the dominant hand for 28 days at night only , and an unsplinted control period of 28 days .\
RESULTS	Arthritis pain was considerably less during both splinted periods when compared with the pretest .\
RESULTS	Subjects identified fewer joints as being painful during the soft splint condition than during the unsplinted condition .\
RESULTS	There were no significant differences among conditions on hand function measures .\
RESULTS	Splint preference was 57 % for the soft splint , 33 % for the hard splint , and 10 % for no splint .\
RESULTS	Splint wear compliance was significantly better with the soft splint ( 82 % ) than with the hard splint ( 67 % ) .\
CONCLUSIONS	The findings indicate that resting hand splints are effective for pain relief and that persons with rheumatoid arthritis are more likely to prefer and comply with soft splint use for this purpose .\
CONCLUSIONS	Individualized splint prescription that focuses on client comfort and preference may enhance splint wear compliance .\
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###14521771\
OBJECTIVE	To evaluate the effect of dietary intervention on lipidemia in school-aged children .\
METHODS	The levels of serum lipids profile were detected in 316 school children aged 7 - 11 , from those the subjects of dietary intervention were selected by total cholesterol level above 4.26 mmol/L or low density lipoprotein cholesterol level above 2.23 mmol/L .\
METHODS	The subjects were randomly divided into intervention group ( 120 ) and control group ( 40 ) .\
METHODS	Children in intervention group were fed with low-cholesterol and low-saturated fatty acid diet , and the control group with normal diet .\
METHODS	The duration of intervention was three months .\
METHODS	Before and after the intervention , the food intakes , health-related questionnaire and physical examination ( height , weight , skinfolds thickness and so on ) in the two groups were studied .\
RESULTS	Compared with the control group , serum cholesterol levels of children under intervention were not significantly changed ( TC : 4.64 vs 4.68 mmol/L , P > 0.05 ; LDL-C : 2.66 vs 2.62 mmol/L , P > 0.05 ) , but the apoA ( 1 ) level increased from 1,378.4 mg/L to 1,441.3 mg/L ( P < 0.05 ) .\
RESULTS	There were no changes for any serum lipids indexes in the control group while the dietary intakes of energy , cholesterol and SFA decreased markedly in the intervention group , with the percent of energy from fat decreased from 40.7 % to 31.2 % and SFA below to 10 % ( 7.7 % ) .\
RESULTS	Along with the increase of the scores of knowledge on health among children under intervention , the living and eating habit improved ( the total scores increased from 24.6 to 27.4 , P < 0.05 ) .\
RESULTS	The increase of height was not significantly different between the two groups .\
CONCLUSIONS	With the family-based high-risk intervention strategy on the dietary adjustment , the knowledge on health , living and eating habit could be effectively improved in children with lipidemia .\
CONCLUSIONS	However , further research about the intervention effect on the serum cholesterol levels by strengthening the interventional degree , needs to be further studied .\
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###19182483\
OBJECTIVE	To evaluate the efficacy of oxcarbazepine ( OXC ) in the treatment of agitation and aggression in patients with Alzheimer 's disease , vascular dementia or both .\
METHODS	This is an 8-week , multicenter , randomized , double-blind , placebo-controlled trial carried out independently of the pharmaceutical industry .\
METHODS	Changes in the agitation and aggression subscore of the Neuropsychiatric Inventory ( NPI ) were the primary outcomes .\
METHODS	The secondary out - comes were the changes in the caregivers ' total burden scores ( measured by the NPI ) and changes in the Brief Agitation Rating Scale ( BARS ) .\
RESULTS	In total , 103 institutionalized patients at 35 sites were randomized to the trial .\
RESULTS	After 8 weeks , no statistically significant differences were found between the 2 groups for all outcomes .\
RESULTS	A trend was observed in favor of the OXC group in the reduction in the scores on the BARS ( p = 0.07 ) .\
CONCLUSIONS	This study found no significant effect of OXC in treatment of agitation and aggression in patients with dementia .\
\
###20883925\
OBJECTIVE	The aim of this study was to evaluate the relative efficacy and safety of zotarolimus-eluting stents ( ZES ) in comparison with the established and widely used sirolimus - ( SES ) and paclitaxel-eluting stents ( PES ) in routine clinical practice .\
BACKGROUND	Whether ZES might provide similar clinical and angiographic outcomes in a broad spectrum of patients compared with SES or PES is undetermined .\
METHODS	We performed a single-blind , multicenter , prospectively randomized trial to compare ZES with SES and PES in 2,645 patients undergoing percutaneous coronary intervention .\
METHODS	The primary end point was a composite of major adverse cardiac events ( MACE ) ( death , myocardial infarction , and ischemia-driven target vessel revascularization ) at 12 months .\
METHODS	A noninferiority comparison ( ZES vs. SES ) and a superiority comparison ( ZES vs. PES ) were performed for the primary end point .\
RESULTS	Baseline clinical and angiographic characteristics were similar in the 3 groups .\
RESULTS	At 12 months , the ZES group showed noninferior rates of MACE compared with the SES group ( 10.2 % vs. 8.3 % , p for noninferiority = 0.01 , p for superiority = 0.17 ) and significantly fewer MACE than the PES group ( 10.2 % vs. 14.1 % , p for superiority = 0.01 ) .\
RESULTS	The incidence of death or myocardial infarction was similar among the groups ( ZES vs. SES vs. PES , 5.8 % vs. 6.9 % vs. 7.6 % , respectively , p = 0.31 ) .\
RESULTS	The incidence of stent thrombosis was significantly lower in the SES group ( ZES vs. SES vs. PES , 0.7 % vs. 0 % vs. 0.8 % , respectively , p = 0.02 ) .\
CONCLUSIONS	In this large-scale , practical randomized trial , the use of ZES resulted in similar rates of MACE compared with SES and in fewer MACE compared with PES at 12 months .\
CONCLUSIONS	( Comparison of the Efficacy and the Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions ; NCT00418067 ) .\
\
###16950470\
BACKGROUND	Functional mitral valve regurgitation attenuation after cardiac resynchronization therapy ( CRT ) in patients with severe heart failure has been attributed to both the increased rate of left ventricular systolic pressure increase and to papillary muscle ( PM ) recoordinated contraction .\
BACKGROUND	We hypothesized that an increase in systolic deformation of the PMs or the adjacent myocardial wall may in part account for this effect , by preventing their outward displacement during systole .\
METHODS	We studied by echocardiography 22 patients with moderate/severe functional mitral valve regurgitation and a mean ejection fraction of 18 + / - 4 % at baseline and after implantation of a CRT system .\
RESULTS	CRT induced a significant reduction of the effective regurgitant orifice area ( 0.18 + / - 0.11 vs 0.35 + / - 0.17 mm2 , P < .001 ) .\
RESULTS	Strain improved in both PMs and their adjacent walls , although this improvement was significant only in anterolateral PM ( -16 + / - 4.7 vs -11 + / - 4.3 % , P = .02 ) and posteromedial PM adjacent wall ( -16 + / - 10 vs -8 + / - 4.6 % , P = .01 ) .\
CONCLUSIONS	CRT acutely reduces the severity of functional mitral valve regurgitation in patients with heart failure and this effect may be in part attributed to improved strain of PM or adjacent wall .\
\
###14627063\
OBJECTIVE	The objective of this study was to demonstrate the utility of continuous monitoring and enhancement of medication compliance during a long-term clinical trial , predictors of compliance , and relationships to drinking outcomes .\
METHODS	Alcohol-dependent patients enrolled in a multicenter VA cooperative study were randomly assigned to once-daily naltrexone ( NTX ) for 3 or 12 months ( short-term or long-term NTX ) or placebo for 12 months of treatment .\
METHODS	All medications were dispensed in bottles with medication event monitoring ( MEMS , AARDEX , Union City , CA ) caps with a microprocessor that recorded openings as presumptive doses .\
METHODS	Patients were trained to develop personal cues as dosing reminders .\
METHODS	Monthly feedback sessions included review of compliance data and cues .\
RESULTS	There were no significant differences among short-term NTX , long-term NTX , and placebo ( 209 each ) groups in measures of compliance .\
RESULTS	Overall compliance rates were 71 % + / - 31 % of doses for the first 13 weeks and 43 % + / - 33 % of doses over 52 weeks .\
RESULTS	Some doses were taken during 83 % + / - 27 % of the first 13 weeks .\
RESULTS	Higher medication compliance predicted fewer drinks per drinking day ( P = .02 ) throughout follow-up and a lower percentage of drinking days ( P = .002 during the first 13 weeks ) with no significant effect for treatment group .\
CONCLUSIONS	The feedback and monitoring programs were important features to demonstrate that lack of treatment effect was not a result of poor compliance .\
CONCLUSIONS	Medication compliance data supported the internal validity of the trial by demonstrating that good compliers had better outcomes , irrespective of treatment with NTX or placebo .\
CONCLUSIONS	The MEMS feedback methodology is feasible for use in multicenter trials .\
\
###23688422\
BACKGROUND	Regular treatment with inhaled corticosteroids ( ICS ) is known to reduce airway hyperresponsiveness ( AHR ) to adenosine 5 ' - monophosphate ( AMP ) in asthma even after a single dose of fluticasone propionate ( FP ) .\
OBJECTIVE	To determine whether this rapid protective effect of a single dose of FP is also present in COPD .\
METHODS	23 mild asthmatic and 24 COPD subjects with documented AHR to both AMP and methacholine took part in a randomized , double-blind , placebo-controlled , crossover study to measure AHR to inhaled AMP and methacholine 2 h after either 1000 g FP or matched placebo .\
RESULTS	In subjects with asthma , 1000 g FP in a single dose significantly attenuated the constrictor response to AMP , geometric mean ( range ) PC20AMP values increasing from a 19.2 ( 1.3-116 .3 ) to 81.5 ( 9.6-1600 .0 ) ( p < 0.001 ; post-placebo vs post-FP ) mg/ml .\
RESULTS	Change in the airways response to inhaled AMP after FP was well within test variability in patients with COPD , with PC20AMP values 59.6 ( 11.3-183 .9 ) and 76.3 ( 21.0-445 .3 ) ( p = 0.022 ; post-placebo vs post-FP ) mg/ml .\
RESULTS	Additionally , FP failed to significantly attenuate the bronchial response to methacholine in both asthma and COPD subjects .\
RESULTS	A change in doubling dilution , between placebo and following a single dose of FP , in AMP had a better sensitivity and specificity of 95.8 % and 65.2 % , compared to methacholine of 79.2 % and 43.5 % respectively in delineating between COPD and asthma .\
CONCLUSIONS	A single dose of 1000 g FP rapidly improves AHR to AMP in asthmatics but not in COPD subjects .\
CONCLUSIONS	This may provide a convenient way by which provocation challenge with inhaled AMP may help in discriminating asthma from COPD .\
\
###8897081\
BACKGROUND	An oral triple therapy using sucralfate instead of a bismuth to eradicate Helicobacter pylori has yielded worse results than those obtained with conventional oral triple therapies .\
BACKGROUND	To date , the effect of sucralfate on the pharmacokinetics of nitroimidazolic compounds used in triple therapy such as with metronidazole is unknown .\
BACKGROUND	The aim of this study was to investigate the effect of a 5-day administration period of sucralfate ( 2 g b.i.d. ) on metronidazole pharmacokinetics .\
METHODS	Fourteen healthy male volunteers were selected .\
METHODS	The study had an open randomized 2-period crossover design with a 14-day washout period between the phases .\
METHODS	The plasma concentration of metronidazole and its hydroxy-metabolite were measured by reverse-phase HPLC with ultraviolet detection .\
RESULTS	No statistically significant difference was observed in any of the pharmacokinetic parameters studied in the absence and presence of sucralfate .\
CONCLUSIONS	Our results clearly indicate that short-term treatment with sucralfate in healthy volunteers does not alter the extent or the rate of metronidazole absorption , and does not affect metronidazole clearance .\
\
###18989343\
OBJECTIVE	To determine the effectiveness of lidocaine 2 % gel vstetracaine 1 % drops in primary pterygium surgery .\
METHODS	This was a prospective , randomised controlled trial .\
METHODS	Forty consecutive patients who had primary pterygium underwent surgical excision of primary pterygium and mitomycin C. Patients were randomised into two groups .\
METHODS	Group 1 received tetracaine 1 % drops and solcoseryl eye gel ( Solco Basel AG , Switzerland ) .\
METHODS	Group 2 received xylocaine 2 % gel ( lidocaine hydrochloride 2 % gel , AstraZeneca , Sweden ) topically and normal saline drops 0.9 % .\
METHODS	Additional tetracaine drops were given to patients who experienced pain preoperatively .\
METHODS	The primary outcome was the pain experienced during and after surgery .\
METHODS	Immediately after the operation , pain and discomfort scores were assessed by the patients and doctor using a 10-point linear analogue scale .\
METHODS	The stages of the operation were divided into the following : stage 1-first incision , stage 2-pterygium body excision , stage 3-conjunctival suturing , and stage 4-immediate postoperative after patching .\
RESULTS	There was no statistically significant difference in the mean pain scores experienced during pterygium excision ( 3.03 + / -2.35 for the lidocaine group and 3.98 + / -2.18 for the tetracaine group ) .\
RESULTS	However , for stage 3 , there was a statistically significant difference in mean pain scores experienced during closure ( P = 0.03 ) ( 0.47 + / -0.84 for the lidocaine gel group and 1.43 + / -1.66 for the tetracaine group ) , with patients of group 2 experienced less pain .\
RESULTS	The mean number of additional drops required by the eyes in lidocaine gel group was also significantly ( 0.16 + / -0.11 ) less than the tetracaine group ( 0.67 + / -0.09 , P = 0.001 ) .\
CONCLUSIONS	Topical administration of lidocaine 2 % gel or tetracaine 1 % drops are both effective anaesthetic agents for primary pterygium surgery and mitomycin C. However , lidocaine gel is superior to tetracaine eye drops and its application is more convenient with a less frequent application and a sustained duration of action .\
\
###11744466\
OBJECTIVE	To assess the efficacy and safety , and determine the optimal dosage , of a once-daily ( OD ) formulation of the clinically uroselective alpha ( 1 ) - blocker , alfuzosin , in patients with lower urinary tract symptoms and symptomatic benign prostatic hyperplasia .\
METHODS	Five hundred thirty-six patients were randomized to receive alfuzosin ( 10 mg OD or 15 mg OD ) , without initial dose titration , or placebo in a 3-month double-blind trial conducted in North America .\
METHODS	The primary efficacy criteria were improvement in symptoms ( International Prostate Symptom Score ) and peak urinary flow rate .\
RESULTS	Alfuzosin was significantly more effective than placebo in improving the symptoms and peak urinary flow rate from the first follow-up visit ( day 28 ) .\
RESULTS	The mean change in the International Prostate Symptom Score from baseline at endpoint was -3.6 and -3.4 with alfuzosin 10 mg and 15 mg , respectively , compared with -1.6 with placebo ( alfuzosin 10 mg versus placebo , P = 0.001 ; alfuzosin 15 mg versus placebo , P = 0.004 ) .\
RESULTS	The median increase in the peak urinary flow rate was +1.1 mL/s and +1.0 mL/s with alfuzosin 10 mg and 15 mg , respectively , compared with 0.0 mL/s with placebo ( P = 0.0006 versus placebo for both dose groups ) .\
RESULTS	The patients ' quality of life also significantly improved with both alfuzosin doses .\
RESULTS	Overall , alfuzosin at both doses was well tolerated .\
RESULTS	The incidence of orthostatic hypotension as determined by systematic blood pressure measurements with both doses of alfuzosin was similar to placebo .\
RESULTS	No clinically relevant ejaculation disorders were observed with alfuzosin .\
CONCLUSIONS	Alfuzosin 10 mg OD , administered without dose titration , provides effective relief from the symptoms of benign prostatic hyperplasia with no additional benefit from a 15-mg dose .\
CONCLUSIONS	It is well tolerated from a cardiovascular viewpoint and is not associated with abnormal ejaculation .\
\
###19087695\
OBJECTIVE	To evaluate the effects of Yunnan Baiyao capsules on facial swelling and anti-inflammatory response after orthognathic surgery .\
METHODS	87 patients scheduled for Le Fort I osteotomy and bilateral sagittal split ramus osteotomy ( BSSRO ) and genioplasty were randomly divided into 2 groups : experiment roup ( n = 43 ) given with Yunnan Baiyao capsules orally 4 days before operation once daily and then via nasal feeding tube after operation once a day for 5 days , and placebo group given with placebo capsules .\
METHODS	Antibiotic was routinely given to both groups .\
METHODS	Serum levels of C-reactive protein ( CRP ) , interleukin 6 ( IL-6 ) , and IL-1 were quantified on postoperative days 1 , 2 , 3 , and 5 .\
METHODS	Degrees of facial swelling were evaluated on postoperative days 3 , 5 , and 7 .\
RESULTS	Peak CRP and cytokines levels were reached on the first postoperative day in both groups , and the the variables decreased .\
RESULTS	The serum concentrations of CRP and IL-6 in the Yunan Baiyao group were lower than those in the control group .\
RESULTS	The CRP levels on the postoperative day 2 , 3 and 5 of the experiment group were all significantly lower than those of the placebo group , and the IL-6 level on the second postoperative day of the experiment group was significantly lower than that of the placebo group .\
CONCLUSIONS	Perioperative administration of Yunnan Baiyao capsules can reduce the magnitude of inflammatory response and facial swelling after orthognathic surgery .\
CONCLUSIONS	Yunnan Baiyao capsule has efficacy of anti-inflammatory response .\
\
###20857087\
OBJECTIVE	The aim of this study is to compare a modified inside-out transobturator procedure with its original counterpart [ inside-out transobturator ( TVT-O ) ] for the treatment of female stress urinary incontinence ( SUI ) .\
METHODS	A prospective , randomized trial in women suffering from SUI was used .\
METHODS	The modified procedure consisted of a shorter tape whilst the scissors or guide no longer perforated the obturator membrane .\
METHODS	The primary outcome was the resolution of subjective and objective SUI at 1year .\
METHODS	Secondary outcome measures included adverse events , quality of life measures , and groin pain .\
RESULTS	One hundred seventy-five patients were randomized .\
RESULTS	No intraoperative complications were recorded .\
RESULTS	The SUI cure rate was 91.7 % versus 90.7 % ( original versus modified , respectively ; p = 0.824 ) .\
RESULTS	Incidence and intensity of groin pain was higher in the original TVT-O group on day0 and 1 ( p < 0.05 ) , requiring more analgesics ( p = 0.015 ) but not thereafter .\
CONCLUSIONS	At 1year follow-up , the modified inside-out transobturator tape procedure was as efficient and safe as the original technique but associated with less immediate postoperative groin pain .\
\
###9829029\
BACKGROUND	We investigated whether the combination of multi-modal behaviour therapy ( BT ) with fluvoxamine is superior to BT and placebo in the acute treatment of severely ill in-patients with obsessive-compulsive disorder ( OCD ) .\
METHODS	In a randomised , double-blind design , 30 patients were treated for nine weeks with BT plus placebo and 30 patients with BT plus fluvoxamine ( maximum dosage 300 mg , mean dose 288.1 mg ) .\
METHODS	BT included exposure with response prevention , cognitive restructuring and development of alternative behaviours .\
RESULTS	Both groups showed a highly significant symptom reduction after treatment .\
RESULTS	There were no significant differences between the groups concerning compulsions .\
RESULTS	Obsessions were significantly more reduced in the fluvoxamine and BT group than in the placebo and BT group .\
RESULTS	Furthermore , the group BT plus fluvoxamine showed a significantly higher response rate ( 87.5 v. 60 % ) according to a previously defined response criterion .\
RESULTS	Severely depressed patients with OCD receiving BT plus placebo presented a significantly worse treatment outcome ( Y-BOCS scores ) than all other groups .\
CONCLUSIONS	The results suggest that BT should be combined with fluvoxamine when obsessions dominate the clinical picture and when a secondary depression is present .\
\
###19426524\
BACKGROUND	Coronary heart disease ( CHD ) is a significant cause of health and economic burden .\
BACKGROUND	Secondary prevention programs play a pivotal role in the treatment and management of those affected by CHD although participation rates are poor due to patient , provider , health system and societal-level barriers .\
BACKGROUND	As such , there is a need to develop innovative secondary prevention programs to address the treatment gap .\
BACKGROUND	Telephone-delivered care is convenient , flexible and has been shown to improve behavioural and clinical outcomes following myocardial infarction ( MI ) .\
BACKGROUND	This paper presents the design of a randomised controlled trial to evaluate the efficacy of a six-month telephone-delivered secondary prevention program for MI patients ( ProActive Heart ) .\
METHODS	550 adult MI patients have been recruited over a 14 month period ( December 2007 to January 2009 ) through two Brisbane metropolitan hospitals , and randomised to an intervention or control group ( n = 225 per group ) .\
METHODS	The intervention commences within two weeks of hospital discharge delivered by study-trained health professionals ( ` health coaches ' ) during up to 10 x 30 minute scripted telephone health coaching sessions .\
METHODS	Participants also receive a ProActive Heart handbook and an educational resource to use during the health coaching sessions .\
METHODS	The intervention focuses on appropriate modification of CHD risk factors , compliance with pharmacological management , and management of psychosocial issues .\
METHODS	Data collection occurs at baseline or prior to commencement of the intervention ( Time 1 ) , six months follow-up or the completion of the intervention ( Time 2 ) , and at 12 months follow-up for longer term outcomes ( Time 3 ) .\
METHODS	Primary outcome measures include quality of life ( Short Form-36 ) and physical activity ( Active Australia Survey ) .\
METHODS	A cost-effective analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government .\
CONCLUSIONS	The results of this study will provide valuable new information about an innovative telephone-delivered cost-effective secondary prevention program for MI patients .\
\
###17437152\
BACKGROUND	The current study was designed to assess the effect of magnesium sulphate infusion on hemodynamic parameters , neuromuscular blocking , propofol consumption , serum concentration of magnesium ions , and recovery from anesthesia during total intravenous anesthesia .\
METHODS	For this study , 60 patients undergoing septorhinoplasty operations were randomly allocated to receive magnesium sulphate ( group M ) or saline ( group C ) intravenously .\
METHODS	The patients in group M received 15 % magnesium sulphate 50 mg/kg in 100 ml of saline , and those in group C received an equal volume of saline before induction of anesthesia followed by 8 mg/kg/h infusion of either magnesium sulphate ( group M ) or an equal volume of saline ( group C ) until the end of surgery .\
METHODS	Anesthesia was induced and maintained with propofol , remifentanil infusions , and vecuronium in both groups .\
RESULTS	Propofol requirements were significantly lower in group M than in group C ( p < 0.05 ) .\
RESULTS	The hemodynamic variables were similar in the two groups .\
RESULTS	The neuromuscular potency of vecuronium was greater in group M than in group C ( p < 0.05 ) .\
RESULTS	The verbal numeric scale values for pain were found to be significantly lower in group M than in group C ( p < 0.05 ) .\
RESULTS	Whereas the serum magnesium was in the normal range at the induction of anesthesia in the both groups , it was significantly lower in group C than in group M postoperatively ( p < 0.05 ) .\
CONCLUSIONS	Magnesium sulphate can be used safely as an adjuvant to total intravenous anesthesia for day case surgeries , with the effect from potentialization of neuromuscular blockade taken into consideration .\
\
###11263519\
METHODS	A tuberculosis ward in a chest disease teaching hospital .\
OBJECTIVE	To compare the efficacy of two different retreatment protocols on hepatotoxicity recurrence in tuberculosis treatment .\
METHODS	In a prospective , randomised study , 45 patients with new tuberculosis developed hepatotoxicity after anti-tuberculosis treatment .\
METHODS	Patients in Group I ( n = 20 ) were retreated with a drug regimen consisting of isoniazid , rifampicin , ethambutol and streptomycin administered by gradually increasing the number and dosage of the drugs .\
METHODS	Patients in Group II ( n = 25 ) were retreated with the same regimen ( isoniazid , rifampicin , pyrazinamide and ethambutol ) in the same dosages throughout .\
RESULTS	Hepatotoxicity recurred in respectively zero and six ( 24 % ) patients in Groups I and II ( P = 0.021 ) .\
RESULTS	Of the six patients with recurrence of hepatitis , one could not be followed up .\
RESULTS	The other five received the same retreatment protocol as Group I. By the end of retreatment , all patients were cured .\
CONCLUSIONS	The recurrence rate of hepatotoxicity in the retreatment of tuberculosis is higher in the reintroduction of a full-dose regimen including pyrazinamide , which causes more hepatotoxicity than gradual reintroduction of a regimen without pyrazinamide .\
\
###17093161\
BACKGROUND	Multiple micronutrient supplementation of Nepalese women during pregnancy is associated with a significant increase in birth weight .\
OBJECTIVE	We tested the hypothesis that improved birth weight in infants of mothers supplemented with micronutrients is associated with a decrease in inflammatory responses and an increase in the production of T helper 1 cells and T helper 2 cells .\
METHODS	The study was embedded in a randomized controlled trial of 15 micronutrients , compared with iron-folate supplementation ( control ) , given during pregnancy with the aim of increasing birth weight .\
METHODS	Blood samples were collected at 32 wk of gestation , 12-20 wk after supplementation began , for the measurement of inflammatory markers .\
METHODS	Breast-milk samples were collected 1 mo after delivery for the measurement of the ratio of milk sodium to potassium ( milk Na : K ) .\
METHODS	In an opportunistically selected subgroup of 70 women , mitogen-stimulated cytokine production was measured ex vivo in whole blood .\
RESULTS	Blood eosinophils ; plasma concentrations of the acute phase reactants C-reactive protein , alpha ( 1 ) - acid glycoprotein ( AGP ) , neopterin , and ferritin ; milk Na : K ; and the production of interleukin ( IL ) 10 , IL-4 , interferon gamma , and tumor necrosis factor alpha in whole blood did not differ significantly between the supplemented and control groups .\
RESULTS	Plasma C-reactive protein and AGP were higher in women who had a preterm delivery , and AGP was higher in women who delivered a low-birth-weight term infant than in women who delivered a normal-birth-weight term infant .\
CONCLUSIONS	The results indicate an association between systemic inflammation in late pregnancy and compromised delivery outcome in Nepalese women but do not support the hypothesis that multiple micronutrient supplementation changes cytokine production or inflammatory markers .\
\
###22377180\
BACKGROUND	Epilepsy is a heterogeneous disorder , with outcomes ranging from immediate remission after taking a first antiepileptic drug to frequent unremitting seizures with multiple treatment failures .\
BACKGROUND	Few prognostic models enable prediction of outcome ; we therefore aimed to use data from the SANAD study to predict outcome overall and for patients receiving specific treatments .\
METHODS	The SANAD study was a randomised controlled trial in which standard antiepileptic drugs were compared with new treatments .\
METHODS	Arm A included patients for whom carbamazepine was considered the first-line treatment , most of whom were newly diagnosed with focal epilepsy .\
METHODS	Patients were randomly assigned to receive carbamazepine , gabapentin , lamotrigine , oxcarbazepine , or topiramate .\
METHODS	Outcomes were time to treatment failure overall , because of inadequate seizure control , and because of adverse events , and time to 12 months of remission from seizures .\
METHODS	In this post-hoc study we used regression multivariable modelling to investigate how clinical factors affect the probability of treatment failure and the probability of achieving 12 months of remission .\
RESULTS	For time to treatment failure , we identified several significant risk factors : sex ( male vs female , hazard ratio [ HR ] 086 , 95 % CI 075-099 ) , treatment history ( taking non-SANAD antiepileptic drugs [ other than those listed above ] vs treatment naive , 127 , 105-153 ) , age ( eg , older than 71 years vs 10 years or younger , 068 , 051-091 ) , total number of seizures ( eg , four to 11 seizures vs two or fewer , 108 , 105-111 ) , electroencephalogram results ( epileptiform abnormality vs normal , 126 , 107-150 ) , seizure type ( eg , secondary generalised vs simple or complex partial only , 078 , 066-091 ) , site of onset ( not localised vs temporal lobe , 125 , 106-147 ) , and treatment ( lamotrigine vs carbamazepine , 076 , 061-095 ) .\
RESULTS	Significant factors for time to 12 months of remission were sex ( male vs female , 119 , 105-135 ) , treatment history ( taking a non-SANAD antiepileptic drug vs treatment naive , 064 , 052-078 ) , age ( eg , older than 71 years vs 10 years or younger , 160 , 126-203 ) , time from first seizure ( 60-239 months vs 2 months , 114 , 101-129 ; > 240 months vs 2 months , 139 , 104-186 ) , neurological insult ( present vs absent , 075 , 061-093 ) , total number of seizures before randomisation ( eg , four to 11 vs two or fewer , 087 , 085-090 ) , and treatment ( gabapentin vs carbamazepine , 071 , 059-086 ; topiramate vs carbamazepine , 081 , 068-098 ) .\
CONCLUSIONS	We present a thorough investigation of prognostic factors from a large randomised controlled trial in patients starting antiepileptic monotherapy .\
CONCLUSIONS	If validated , our models could aid in individual patient risk stratification and the design and analysis of epilepsy trials .\
BACKGROUND	National Institute for Health Research ( UK ) .\
\
###12417542\
BACKGROUND	Brain natriuretic peptide ( BNP ) and norepinephrine ( NE ) are strongly related to severity of and are independent predictors of outcome in heart failure .\
BACKGROUND	The long-term effects of angiotensin receptor blockers on BNP and NE in heart failure patients are not known .\
RESULTS	Both BNP and NE were measured in 4284 patients randomized to valsartan or placebo in the Valsartan Heart Failure Trial ( Val-HeFT ) at baseline and 4 , 12 , and 24 months after randomization .\
RESULTS	The effects of valsartan were tested by ANCOVA , controlling for baseline values and concomitant ACE inhibitors and/or beta-blockers .\
RESULTS	BNP and NE concentrations were similar at baseline in the 2 groups and were decreased by valsartan starting at 4 months and up to 24 months .\
RESULTS	BNP increased over time in the placebo group .\
RESULTS	At the end point , least-squares mean ( + / - SEM ) BNP increased from baseline by 23 + / -5 pg/mL in the placebo group ( n = 1979 ) but decreased by 21 + / -5 pg/mL ( n = 1940 ) in the valsartan group ( P < 0.0001 ) .\
RESULTS	NE increased by 41 + / -6 pg/mL ( n = 1979 ) and 12 + / -6 pg/mL ( n = 1941 ) for placebo and valsartan , respectively ( P = 0.0003 ) .\
RESULTS	Concomitant therapy with both ACE inhibitors and beta-blockers significantly reduced the effect of valsartan on BNP but not on NE ( P for interaction = 0.0223 and 0.2289 , respectively ) .\
CONCLUSIONS	In Val-HeFT , the largest neurohormone study in patients with symptomatic chronic heart failure , BNP and NE rose over time in the placebo group .\
CONCLUSIONS	Valsartan caused sustained reduction in BNP and attenuated the increase in NE over the course of the study .\
CONCLUSIONS	These neurohormone effects of valsartan are consistent with the clinical benefits reported in Val-HeFT .\
\
###20979675\
OBJECTIVE	To determine the feasibility of a randomized controlled trial of the effect of a tai chi program on quality of life and exercise capacity in patients with COPD .\
METHODS	We randomized 10 patients with moderate to severe COPD to 12 weeks of tai chi plus usual care ( n = 5 ) or usual care alone ( n = 5 ) .\
METHODS	The tai chi training consisted of a 1-hour class , twice weekly , that emphasized gentle movement , relaxation , meditation , and breathing techniques .\
METHODS	Exploratory outcomes included disease-specific symptoms and quality-of-life , exercise capacity , pulmonary function tests , mood , and self-efficacy .\
METHODS	We also conducted qualitative interviews to capture patient narratives regarding their experience with tai chi .\
RESULTS	The patients were willing to be randomized .\
RESULTS	Among 4 of the 5 patients in the intervention group , adherence to the study protocol was excellent .\
RESULTS	The cohort 's baseline mean SD age , percent-of-predicted FEV , and ratio of FEV to forced vital capacity were 66 6 y , 50 12 % , and 0.63 0.14 , respectively .\
RESULTS	At 12 weeks there was significant improvement in Chronic Respiratory Questionnaire score among the tai chi participants ( 1.4 1.1 ) , compared to the usual-care group ( -0.1 0.4 ) ( P = .03 ) .\
RESULTS	There were nonsignificant trends toward improvement in 6-min walk distance ( 55 47 vs -13 64 m , P = .09 ) , Center for Epidemiologic Studies Depression Scale ( -9.0 9.1 vs -2.8 4.3 , P = .20 ) , and University of California , San Diego Shortness of Breath score ( -7.8 3.5 vs -1.2 11 , P = .40 ) .\
RESULTS	There were no significant changes in either group 's peak oxygen uptake .\
CONCLUSIONS	A randomized controlled trial of tai chi is feasible in patients with moderate to severe COPD .\
CONCLUSIONS	Tai chi exercise as an adjunct to standard care warrants further investigation .\
\
###15640461\
BACKGROUND	The cholesterol-lowering abilities of rice bran 's fiber and oil apart from its fatty acid composition remain unclear .\
OBJECTIVE	The objective of the study was to assess the effects of defatted rice bran and rice bran oil in an average American diet on blood lipids in moderately hypercholesterolemic persons .\
METHODS	Study 1 used a parallel-arm design .\
METHODS	Twenty-six healthy volunteers consumed a diet with 13-22 g dietary fiber/d for 3 wk , and then 13 of the volunteers were switched to a diet with defatted rice bran to double the fiber intake for 5 wk .\
METHODS	Study 2 was a randomized , crossover , 10-wk feeding study performed in 14 volunteers who consumed a diet with rice bran oil ( 1/3 of the total dietary fat ) substituted for an oil blend that had a fatty acid composition similar to that of the rice bran oil .\
METHODS	Serum lipids and factor VII were measured in both studies .\
RESULTS	Defatted rice bran did not lower lipid concentrations .\
RESULTS	In study 2 , total cholesterol was significantly lower with consumption of the diet containing rice bran oil than with consumption of the control diet .\
RESULTS	Moreover , with consumption of the rice bran oil diet , LDL cholesterol decreased by 7 % ( P < 0.0004 ) , whereas HDL cholesterol was unchanged .\
CONCLUSIONS	Rice bran oil , not fiber , lowers cholesterol in healthy , moderately hypercholesterolemic adults .\
CONCLUSIONS	There were no substantial differences in the fatty acid composition of the diets ; therefore , the reduction of cholesterol was due to other components present in the rice bran oil , such as unsaponifiable compounds .\
\
###23252914\
OBJECTIVE	To assess the effect of an intervention on drug-related problem ( DRP ; adverse drug reactions , adherence problems , underuse ) - related readmission rates in older adults .\
METHODS	Ancillary study from a 6-month , prospective , randomized , parallel-group , open-label trial .\
METHODS	Six acute geriatric units in Paris and suburbs .\
METHODS	Six hundred sixty-five consecutively admitted individuals were included : 317 in the intervention group ( IG ) and 348 in the control group ( CG ) ( aged 86.1 6.2 , 66 % female ) .\
METHODS	Discharge-planning intervention combining chronic drug review , education , and enhanced transition-of-care communication .\
METHODS	Chronic drugs at discharge of the two groups were compared .\
METHODS	An expert committee blinded to group assignment adjudicated whether 6-month readmission to the study hospitals was related to drugs .\
RESULTS	Six hundred thirty-nine individuals were discharged and followed up ( 300 IG , 339 CG ) .\
RESULTS	The intervention had no significant effect on drug regimen at discharge , characterized by prescriptions that are mostly appropriate but increase iatrogenic risk .\
RESULTS	Three hundred eleven readmissions occurred during follow-up ( 180 CG , 131 IG ) , of which 185 ( 59.5 % ) were adjudicated ( 102 CG , 83 IG ) .\
RESULTS	For 16 , DRP imputability was doubtful .\
RESULTS	Of the remaining 169 , DRPs were the most frequent cause for readmission , with 38 ( 40.4 % ) readmissions in the CG and 26 ( 34.7 % ) in the IG ( relative risk reduction = 14.3 % , 95 % confidence interval = 14.0-14 .5 % , P = .54 ) .\
RESULTS	The intervention was associated with 39.7 % fewer readmissions related to adverse drug reactions ( P = .12 ) despite the study 's lack of power .\
CONCLUSIONS	Drug-related problem prevention in older people discharged from the hospital should be a priority , with a focus on improving the monitoring of drugs with high iatrogenic risk .\
\
###16047062\
OBJECTIVE	Implementation of a pilot screening program for prostate cancer among Saudi patients that would serve as a nucleus for a Kingdom-wide screening program .\
METHODS	A prospective study on 1,213 Saudi males between 50-80 years of age who attended the Outpatient Department at King Fahd Hospital of King Faisal University , Al-Khobar , Kingdom of Saudi Arabia during a period of 18 months ( April 2001-October 2002 ) .\
METHODS	They were included at random from different clinics including the urology clinic .\
METHODS	Free and total prostate specific antigen ( PSA ) , and digital rectal examination ( DRE ) of the prostate were performed in all patients .\
METHODS	Patients with abnormal DRE or PSA were scheduled for transrectal ultrasound ( TRUS ) and ultrasound guided biopsy of the prostate .\
RESULTS	Abnormal DRE or PSA were present in 84 out of 1,213 patients .\
RESULTS	Only 63 patients agreed to have TRUS and ultrasound guided biopsies .\
RESULTS	Prostate cancer was confirmed in 14 out of 1,192 patients who completed the study ( 1.17 % ) .\
CONCLUSIONS	The incidence of prostate cancer among Saudi men in this hospital based study is low .\
CONCLUSIONS	A population based screening for prostate cancer may reveal the incidence of this disease .\
\
###14658972\
BACKGROUND	Sleep complaints are common in patients with major depressive disorder ( MDD ) .\
BACKGROUND	Both MDD and antidepressant drugs characteristically alter objective sleep measures .\
BACKGROUND	This study compares the effects of mirtazapine and fluoxetine on sleep continuity measures in DSM-IV MDD patients with insomnia .\
METHODS	Patients ( N = 19 ) received initial baseline polysomnography evaluations over 2 consecutive nights .\
METHODS	Subjects were randomly assigned to either fluoxetine ( 20-40 mg/day ) or mirtazapine ( 15-45 mg/day ) treatment for an 8-week , double-blind , double-dummy treatment trial .\
METHODS	Single-night polysomnograms were conducted at weeks 1 , 2 , and 8 , with depression ratings assessed at baseline and weeks 1 , 2 , 3 , 4 , 6 , and 8 .\
METHODS	Statistical analysis was performed by repeated-measures analysis of variance followed by Dunnet 's post hoc analyses .\
RESULTS	Patients receiving mirtazapine ( N = 8 ) had significant improvement in objective sleep physiology measures at 8 weeks .\
RESULTS	Improvements in sleep latency , sleep efficiency , and wake after sleep onset were significant after only 2 weeks of mirtazapine treatment .\
RESULTS	No significant changes in sleep continuity measures were observed in the fluoxetine group ( N = 11 ) .\
RESULTS	Both groups improved clinically in mood and subjective sleep measures from baseline , with no differences between groups .\
CONCLUSIONS	These data demonstrate the differential effects of mirtazapine and fluoxetine , with significant improvement in favor of mirtazapine , on objective sleep parameters in MDD patients with insomnia .\
\
###16411026\
BACKGROUND	Optimizing the validity and responsiveness of utility measures will enhance their usefulness in randomized trials .\
BACKGROUND	We evaluated the impact of clinical marker state ( CMS ) rating prior to patients ' rating their own health on two utility instruments ( feeling thermometer ( FT ) and standard gamble ( SG ) ) in patients with chronic respiratory disease ( CRD ) .\
METHODS	We randomized 182 patients with CRD to complete the FT ( self-administered ) and SG with CMS ( FT + / SG + , n = 91 ) or without marker states ( FT - / SG - , n = 91 ) before and after undergoing respiratory rehabilitation in a multi-center trial .\
RESULTS	Use of CMS did not influence baseline utility scores .\
RESULTS	Improvement after therapy on the scale from 0 ( dead ) to 1.0 ( full health ) was 0.04 both in FT + ( p = 0.03 ) and FT - ( p = 0.02 ; the difference between FT + and FT - was 0.00 , p = 0.83 ) .\
RESULTS	Improvement on the SG was 0.05 in both SG + ( p = 0.08 ) and SG - ( p = 0.04 ; difference between SG + and SG - 0.00 , p = 0.95 ) .\
RESULTS	Correlations with other health related quality of life scores were highest for FT + .\
CONCLUSIONS	Administration of CMS did not improve responsiveness of the FT but may have improved construct validity .\
CONCLUSIONS	The SG showed limited construct validity and responsiveness that was not influenced by CMS use .\
\
###20550024\
OBJECTIVE	A reduction in core temperature and an increase in the distal-proximal skin gradient ( DPG ) are reported to be associated with shorter sleep onset latencies ( SOL ) and better sleep quality .\
OBJECTIVE	Ramelteon is a melatonin MT-1 / MT-2 agonist approved for the treatment of insomnia .\
OBJECTIVE	At night , ramelteon has been reported to shorten SOL .\
OBJECTIVE	In the present study we tested the hypothesis that ramelteon would reduce core temperature , increase the DPG , as well as shorten SOL , reduce wakefulness after sleep onset ( WASO ) , and increase total sleep time ( TST ) during a daytime sleep opportunity .\
METHODS	Randomized , double-blind , placebo-controlled , cross-over design .\
METHODS	Eight mg ramelteon or placebo was administered 2 h prior to a 4-h daytime sleep opportunity .\
METHODS	Sleep and chronobiology laboratory .\
METHODS	Fourteen healthy adults ( 5 females ) , aged ( 23.2 + / - 4.2 y ) .\
RESULTS	Primary outcome measures included core body temperature , the DPG and sleep physiology ( minutes of total sleep time [ TST ] , wake after sleep onset [ WASO ] , and SOL ) .\
RESULTS	We also assessed as secondary outcomes , proximal and distal skin temperatures , sleep staging and subjective TST .\
RESULTS	Repeated measures ANOVA revealed ramelteon significantly reduced core temperature and increased the DPG ( both P < 0.05 ) .\
RESULTS	Furthermore , ramelteon reduced WASO and increased TST , and stages 1 and 2 sleep ( all P < 0.05 ) .\
RESULTS	The change in the DPG was negatively correlated with SOL in the ramelteon condition .\
CONCLUSIONS	Ramelteon improved daytime sleep , perhaps mechanistically in part by reducing core temperature and modulating skin temperature .\
CONCLUSIONS	These findings suggest that ramelteon may have promise for the treatment of insomnia associated with circadian misalignment due to circadian sleep disorders .\
\
###22282478\
OBJECTIVE	The optimal maintenance immunosuppressive regimen to improve long-term renal allograft function and graft survival is yet to be determined .\
METHODS	This observational study prospectively compared tacrolimus/sirolimus with tacrolimus/mycophenolate mofetil in renal transplant recipients using a prednisone-free regimen with over 8.5 years of follow-up .\
METHODS	Patients received methylprednisonlone and anti-IL2 receptor antagonist ( Basiliximab ) induction and were blindly randomized to either the tacrolimus/mycophenolate mofetil ( n = 45 ) or tacrolimus/sirolimus ( n = 37 ) groups .\
METHODS	Outcome measures included patient and renal allograft survival , incidence of acute rejection , and estimated GFR .\
RESULTS	The tacrolimus/mycophenolate mofetil group compared with the tacrolimus/sirolimus group had overall better renal allograft survival ( 91 % versus 70 % , P = 0.02 ) ; 13 patients ( 35.1 % ) in the tacrolimus/sirolimus group and 8 patients ( 17.8 % ) in the tacrolimus/mycophenolate mofetil group experienced biopsy-proven acute cellular rejection ( P = 0.07 ) .\
RESULTS	By 3 months post-transplant , estimated GFR was significantly lower in the tacrolimus/sirolimus group compared with the tacrolimus/mycophenolate mofetil group ( 47.7 versus 59.6 ml/min per 1.73 m ( 2 ) , P = 0.0002 ) , and this trend persisted throughout the follow-up period .\
RESULTS	Also , the slope of decline in the tacrolimus/sirolimus group was significantly steeper than in the tacrolimus/mycophenolate mofetil group .\
CONCLUSIONS	This study shows that , in a prednisone-free immunosuppressive regimen , long-term renal graft survival and function are significantly worse in the tacrolimus/sirolimus group than the tacrolimus/mycophenolate mofetil group .\
CONCLUSIONS	The synergistic nephrotoxic effect and higher acute rejection rates in the tacrolimus/sirolimus compared with the tacrolimus/mycophenolate mofetil group adversely affect graft survival .\
\
###11834991\
BACKGROUND	The PerCutaneous Compression Plate ( PCCP ) was developed by Gotfried ( Israel , Haifa ) for minimal-approach osteosynthesis of pertrochanteric fractures .\
METHODS	One hundred fifteen patients , aged 60 or more , with intertrochanteric fractures ( AO type 31A1 or 31A2 ) were selected randomly for fixation with either the PCCP ( 53 patients ) or the Dynamic Hip Screw ( 62 patients ) .\
METHODS	All surviving patients were scheduled for a 1-year follow-up .\
RESULTS	Less invasive surgical stabilization of pertrochanteric fractures with the PCCP resulted in shorter theater and surgical time and reduced postoperative pain .\
RESULTS	The PCCP treatment showed a tendency toward a lower transfusion need and a reduction of fracture impaction ; however , results were not statistically significant .\
RESULTS	There was a trend toward a higher mechanical complication rate with the PCCP : anatomic closed reduction without posterior sagging of the fracture and fluoroscopic control of the placement of the first neck screw in two directions are essential to avoid technical complications .\
CONCLUSIONS	Minimal invasive treatment of pertrochanteric fractures with the PCCP reduces operation time and postoperative pain .\
\
###18180664\
OBJECTIVE	To assess whether easy access to medical information of the emergency department 's ( ED ) frequent users would be useful to patient care in the ED and at primary healthcare centres ( PHCs ) , and if resource utilization in the following year would be affected .\
METHODS	During a 6-month period , frequent users presenting to the ED of Karolinska University Hospital Huddinge , Sweden , were randomized by the electronic database system into an intervention ( n = 834 ) or control group ( n = 965 ) , the definition being three or more visits in 12 months before the index visit .\
METHODS	Printout case notes , from the intervention patients ' last three visits , were made accessible to the ED physicians and optionally forwarded to the patient 's PHC physician .\
METHODS	Usefulness of this enhanced information was measured by questionnaires , whereas healthcare utilization was compiled from the electronic database .\
RESULTS	The case notes of 59 ( 7.1 % ) intervention patients were forwarded to the respective PHCs .\
RESULTS	Of these , access to the enhanced patient information was deemed useful in 82 % cases in the ED , versus 76 % in PHCs .\
RESULTS	The mean number of ED visits in the following year did not differ significantly in the total intervention group as compared with the controls : 4.0 and 3.9 , respectively ( P = 0.49 ) .\
RESULTS	Nor were there any differences in utilization of other care resources .\
CONCLUSIONS	Although only a small subgroup 's information was shared , yielding no decrease in overall healthcare utilization , the study indicated benefits of the enhanced information at the respective care level and also had important clinical and organizational implications .\
\
###23489530\
OBJECTIVE	The objective of this substudy of the ASTRONOMER ( Aortic Stenosis Progression Observation : Measuring Effects of Rosuvastatin ) trial was to examine the association between insulin resistance and progression of left ventricular hypertrophy ( LVH ) in patients with aortic stenosis ( AS ) .\
BACKGROUND	In a recent cross-sectional study , the authors reported that the metabolic syndrome was associated with an increased prevalence of concentric LVH in patients with AS .\
BACKGROUND	As a central feature of the metabolic syndrome , insulin resistance could be an important mediator of this association .\
METHODS	This substudy included 250 of 269 patients enrolled in ASTRONOMER .\
METHODS	Follow-up was 3.4 1.3 years .\
METHODS	Insulin resistance was evaluated using the homeostatic assessment model ( HOMA ) index , and patients were dichotomized using the median HOMA index value ( 1.24 ) .\
METHODS	The rate of LVH progression was estimated by calculating the annualized change in LV mass index ( LVMi ) , measured on echocardiography .\
METHODS	The presence of LVH was defined as an LVMi > 47 g/m ( 2.7 ) in women and > 49 g/m ( 2.7 ) in men .\
RESULTS	There was a significant progression of LVH among the patients without LVH at baseline ( n = 134 ; p < 0.0001 ) but not in those with it ( n = 116 ; p = NS ) .\
RESULTS	In those without LVH at baseline , the annualized progression rate of LVMi was significantly faster in the subset with HOMA > 1.24 compared to that in the subset with HOMA < 1.24 ( 2.49 4.38 g/m ( 2.7 ) / year vs. -0.03 3.90 g/m ( 2.7 ) / year ; p = 0.001 ) .\
RESULTS	During follow-up , LVH developed in 46 % of patients with HOMA > 1.24 compared to 11 % of those with HOMA < 1.24 ( p = 0.0005 ) .\
RESULTS	Independent predictors of faster LVH progression identified on multivariate analysis were history of hypertension ( p = 0.048 ) , degree of aortic valve calcification ( p = 0.035 ) , and HOMA index ( p = 0.02 ) .\
CONCLUSIONS	In this ASTRONOMER substudy , insulin resistance was a powerful independent predictor of progression to LVH in patients with AS .\
CONCLUSIONS	Visceral obesity and ensuing insulin resistance may thus present novel therapeutic targets in AS patients .\
\
###20471706\
BACKGROUND	Digoxin has been shown to reduce heart failure ( HF ) hospitalizations with no overall effect on mortality in HF patients .\
BACKGROUND	We used cluster analysis to delineate the clinical characteristics of HF patients in whom digoxin therapy was associated with improved or worsened clinical outcomes .\
METHODS	The Digitalis Investigation Group ( DIG ) database was partitioned into 20 clusters .\
METHODS	Multivariate Cox regression analyses was used , to identify clusters in which digoxin was associated with either an increase ( Mortality ( dig ) HR > 1 ) , decrease ( Mortality ( dig ) HR < 1 ) , or no association with all cause mortality ( Mortality ( dig ) HR-NS ) ; and separately , with an increase ( HFA ( dig ) HR > 1 ) , decrease ( HFA ( dig ) HR < 1 ) , or no association ( HFA ( dig ) HR-NS ) with HF admissions ( HFA ) .\
RESULTS	We identified 938 patients in the Mortality ( dig ) HR > 1 group , 6818 patients in the Mortality ( dig ) HR-NS group , and none in Mortality ( dig ) HR < 1 group .\
RESULTS	The Mortality ( dig ) HR > 1 group had a higher prevalence of females , diabetes mellitus , hypertension , higher age , systolic blood pressure ( SBP ) , heart rate and ejection fraction ( EF ) , compared to the Mortality ( dig ) HR-NS group .\
RESULTS	Similarly , 6325 patients clustered in the HFA ( dig ) HR < 1 group , 1431 patients in the HFA ( dig ) HR-NS group , and none in the HFA ( dig ) HR > 1 group .\
RESULTS	The HFA ( dig ) HR-NS group had a higher prevalence of females and hypertension , higher SBP , body mass index and EF ; and lower prevalence of peripheral edema and third heart sound , compared with the HFA ( dig ) HR < 1 group .\
CONCLUSIONS	Thus , the baseline characteristics of patients who did not have reduction in HF hospitalization or who had increased mortality were very similar and included females with hypertension , higher EF and higher SBP .\
CONCLUSIONS	Thus , use of digoxin in patients with this profile may need to be avoided .\
\
###15053885\
OBJECTIVE	To investigate the effect of a specially selected music sound environment on the feeling of wellbeing of adult , lightly sedated patients in a Cardiac Catheter Laboratory undergoing invasive procedures .\
METHODS	Patients ( n = 193 ) were randomly assigned to either a music group , who listened to music during the procedure ( n = 99 ) or to a non-music group ( n = 94 ) .\
METHODS	Immediately after the procedure all patients were interviewed by a questionnaire about their opinion of the sound environment in the room and about their feeling of wellbeing .\
RESULTS	In the music group 91 % of the patients defined the sound environment as very pleasant/pleasant - compared to 56 % in the non-music group .\
RESULTS	The number of patients with ` no opinion ' on the sound environment was lower in the music group than in the non-music group ( 8 % vs. 42 % ) .\
RESULTS	In the non-music group only 34 % of the patients would have liked to listen to music , if possible , whereas 82 % of the patients in the music group were very pleased/pleased with the music .\
RESULTS	Both groups noticed basic sounds and noises with similar frequencies .\
RESULTS	In the music group 62 % of the patients noticed the music spontaneously .\
RESULTS	Sixty-eight patients ( 68 % ) reported that music was of major positive importance to their feeling of wellbeing .\
RESULTS	These patients expressed that music made them feel less tense , more relaxed and safe .\
RESULTS	The results were not related to age , sex or procedure .\
CONCLUSIONS	Specially selected music had a positive effect on the wellbeing of patients and their opinion on the sound environment during invasive cardiac procedures .\
CONCLUSIONS	Based on the negative expectations and the positive experience of the patients with regard to music environment , we suggest that specially selected music should be a part of the sound environment in the Cardiac Catheter Laboratory .\
\
###19177029\
OBJECTIVE	To develop a warfarin-dosing algorithm that could be combined with pharmacogenomic and demographic factors , and to evaluate its effectiveness in a randomized prospective controlled clinical trial .\
METHODS	A pharmacogenetics-based dosing model was derived using retrospective data from 266 Chinese patients and multiple linear regression analysis .\
METHODS	To prospectively validate this model , 156 patients with an operation of heart valve replacement were enrolled and randomly assigned to the group of pharmacogenetics-guided or traditional dosing for warfarin therapy .\
METHODS	All patients were followed up for 50 days after initiation of warfarin therapy .\
METHODS	The log-rank test was compared with the time-to-event ( Kaplan-Meier ) curves .\
METHODS	Cox proportional hazards-regression model was used to assess the hazard ratio of the time to reach stable dose .\
RESULTS	The linear regression model derived from the pharmacogenomic model correlated with 54.1 % of warfarin dosing variance .\
RESULTS	The final multiple linear regression model included age , body surface area , VKORC1 , and CYP2C9 genotype .\
RESULTS	The study showed that the hazard ratio for the time to reach stable dose was 1.932 for the traditional dosing group versus the model-based group and a close and highly significant relationship was observed to exist between the predicted and the actual warfarin dose ( R = 0.454 ) .\
CONCLUSIONS	A pharmacogenetics-based dosing algorithm has been developed for improvement in the time to reach the stable dosing of warfarin .\
CONCLUSIONS	This model may be useful in helping the clinicians to prescribe warfarin with greater safety and efficiency .\
\
###19954996\
OBJECTIVE	Intracostal suture or intercostal muscle flap can reduce post-thoracotomy pain through the preservation of intercostal nerves below or above the incision .\
OBJECTIVE	This study aims to test whether combining intracostal suture with intercostal muscle flap might achieve better pain relief than intracostal suture alone .\
METHODS	This study included 144 consecutive patients who underwent pulmonary resection .\
METHODS	Eighty patients entered the trial but eight were excluded .\
METHODS	Seventy-two patients were randomly assigned to a muscle flap group , in which the fifth intercostal muscle and neurovascular bundle were raised and intracostal suture on the sixth rib was applied .\
METHODS	For the control group , only intracostal suturing on the sixth rib was done .\
METHODS	All patients had a functional epidural placed , which were removed 24h after surgery .\
METHODS	Differences on average numeric rating scale ( aNRS ) scores were assessed in an early post-operative period from day 1 to day 7 and a later period from week 2 to week 12 , when patients were resting or coughing .\
METHODS	The doses of oxycodone demand and hyperalgesia-related intercostal dermatomes ( HIDs ) were recorded for analysis .\
RESULTS	No differences were noted between the two groups in terms of length and width of the incision , or duration of rib retraction .\
RESULTS	Neither in different time periods ( early or late ) nor the activity status ( while resting or coughing ) yielded a statistical difference on aNRS scores between the muscle flap group and the control group ( muscle flap group vs control group : mean ( 95 % confidence intervals ) from d ay 1 to day 7 , 4.42 ( 1.56-7 .28 ) vs 4.79 ( 2.03-7 .55 ) on coughing ( p = 0.282 ) ; median ( inter-quartile range , IQR ) from day 1 to day 7 , 1.71 ( 0.86-3 ) vs 2.50 ( 1.16-3 .12 ) while resting ( p = 0.279 ) ; median ( IQR ) from week 2 to week 12 , 0.43 ( 0-0 .86 ) vs 0.48 ( 0.06-1 .20 ) on coughing ( p = 0.595 ) ; median ( IQR ) from week 2 to week 12 , 0 ( 0-0 .14 ) vs 0.05 ( 0-0 .14 ) while resting ( p = 0.856 ) ) .\
RESULTS	No differences were found in total oxycodone consumption from day 1 to day 7 between the two groups ( Z = -1.821 , p = 0.069 ) .\
RESULTS	The rate of HIDs in each intercostal space and median number of HIDs were similar between the two groups on day 1 ( p > 0.05 ) and day 7 ( p > 0.05 ) .\
CONCLUSIONS	The combination of intracostal suture with intercostal muscle flap may not necessarily achieve better post-thoracotomy pain control than using intracostal suture alone .\
\
###21819556\
BACKGROUND	Long-term immunosuppression is often required in myasthenia gravis ( MG ) .\
BACKGROUND	There are no published trials using methotrexate ( MTX ) in MG .\
BACKGROUND	The steroid-sparing efficacy of azathioprine ( AZA ) has been demonstrated after 18-months of starting therapy .\
BACKGROUND	However , AZA is considered expensive in Africa .\
BACKGROUND	We evaluated the steroid-sparing efficacy of MTX ( 17.5 mg weekly ) compared with AZA ( 2.5 mg/kg daily ) in subjects recently diagnosed with generalized MG by assessing their average monthly prednisone requirements .\
METHODS	The primary outcome was the average daily prednisone requirement by month between the two groups .\
METHODS	Prednisone was given at the lowest dose to manage MG symptoms and adjusted as required according to protocol .\
METHODS	Single-blinded assessments were performed 3-monthly for 2-years to determine the quantitative MG score and the MG activities of daily living score in order to determine those with minimal manifestations of MG .\
RESULTS	Thirty-one subjects ( AZA n = 15 ; MTX n = 16 ) satisfied the inclusion criteria but only 24 were randomized .\
RESULTS	Baseline characteristics were similar .\
RESULTS	There was no difference between the AZA - and MTX-groups in respect of prednisone dosing ( apart from months 10 and 12 ) , in quantitative MG Score improvement , proportions in sustained remission , frequencies of MG relapses , or adverse reactions and/or withdrawals .\
RESULTS	The MTX-group received lower prednisone doses between month 10 ( p = 0.047 ) and month 12 ( p = 0.039 ) .\
RESULTS	At month 12 the prednisone dose per kilogram bodyweight in the MTX-group ( 0.15 mg/kg ) was half that of the AZA-group ( 0.31 mg/kg ) ( p = 0.019 ) .\
CONCLUSIONS	This study provides evidence that in patients with generalized MG methotrexate is an effective steroid-sparing agent 10 months after treatment initiation .\
CONCLUSIONS	Our data suggests that in generalized MG methotrexate has similar efficacy and tolerability to azathioprine and may be the drug of choice in financially constrained health systems .\
BACKGROUND	SANCTR : DOH-27-0411-2436 .\
\
###24837754\
BACKGROUND	Despite their positive motivation to quit , many smokers do not attempt to quit or relapse soon after their quit attempt .\
BACKGROUND	This study investigated the predictors of successful and unsuccessful quit attempts among smokers motivated to quit smoking .\
METHODS	We conducted secondary data analysis among respondents motivated to quit within 6 months , randomized to the control group ( N = 570 ) of a Web-based smoking cessation intervention study .\
METHODS	Using chi-square tests and ANOVA with Tukey post hoc comparisons , we investigated baseline differences by smoking status ( successful quitter/relapse/persistent smoker ) assessed after 6 weeks ( N = 214 ) .\
METHODS	To identify independent predictors of smoking status , multivariate multinomial logistic regression analyses were conducted .\
RESULTS	Successful quitters at 6-week follow-up ( 26 % ) had reported significantly higher baseline levels of self-efficacy than relapsers ( 45 % ) and persistent smokers ( 29 % ) .\
RESULTS	Furthermore , both successful quitters and relapsers had reported a significantly higher baseline intention to quit than persistent smokers and successful quitters had reported significantly more preparatory planning at baseline than persistent smokers .\
RESULTS	Results from regression analyses showed that smokers ' baseline intention to quit positively predicted quit attempts reported after 6 weeks , while self-efficacy positively predicted quit attempt success .\
CONCLUSIONS	Different factors appear to play a role in predicting quit attempts and their success .\
CONCLUSIONS	Whereas intention to quit only appeared to play a role in predicting quit attempts , self-efficacy was the main factor predicting quit attempt success .\
CONCLUSIONS	More research is needed to determine the role of preparatory planning and plan enactment and to investigate whether these findings can be replicated on the long term .\
\
###9386652\
OBJECTIVE	We studied the ability of carbazochrome sodium sulfonate ( AC-17 ) to prevent capillary permeability in dengue hemorrhagic fever/dengue shock syndrome .\
METHODS	A randomized , placebo-controlled trial in 95 children stratified by age and sex was conducted in two hospitals during 1992 .\
METHODS	AC-17 ( n = 45 cases ) or B vitamins as placebo ( n = 50 ) were given as a bolus infusion and then as a continuous drip for 24 hours ; a total of 300 mg of AC-17 was administered on the first 2 days and 150 mg on the third day .\
RESULTS	The two groups were comparable in age , sex , duration of illness , and clinical manifestations .\
RESULTS	No significant difference in shock or pleural effusion was noted between the two groups .\
RESULTS	Shock developed in 8.9 % ( 4/45 ) of patients in the AC-17 group and 6 % ( 3/50 ) in the placebo group ( p = 0.44 ) .\
RESULTS	Pleural effusion was found at 0 , 24 , 48 , and 72 hours after admission in 4.4 % , 20 % , 31.1 % , and 20 % in the AC-17 group and 2 % , 14 % , 28 % , and 14 % in the placebo group , respectively .\
CONCLUSIONS	Administration of AC-17 does not prevent plasma leakage or shock in dengue hemorrhagic fever/dengue shock syndrome .\
\
###24288077\
OBJECTIVE	Anterior knee pain is a major cause of complaint in total knee arthroplasty ( TKA ) without patellar resurfacing .\
OBJECTIVE	The concept of improved patellar tracking and decreased retropatellar contact pressure for lateral retinacular release theoretically suggests that patients with lateral retinacular release in TKA would achieve a lower incidence of anterior knee pain when compared without lateral retinacular release .\
OBJECTIVE	We sought to determine ( 1 ) whether those patients who received a routine lateral retinacular release in TKA would attain lower incidence of anterior knee pain as compared to patients who received TKA without lateral retinacular release and ( 2 ) whether lateral retinacular release would increase the lateral retinacular release-related complications .\
METHODS	A total of 148 patients who underwent TKA with the use of the Gemini MK II mobile bearing were randomized to receive either routine lateral retinacular release ( intervention group ) or not ( control group ) .\
METHODS	Patients were assessed by the visual analogue scale for anterior knee pain , the Knee Society clinical scoring system of knee score and function score , and patellar score for clinical function .\
METHODS	Patients ' satisfaction and lateral retinacular release-related complications were also evaluated .\
RESULTS	The overall incidence of anterior knee pain in the intervention group at 18 months follow-up was 5.6 % , while that of the control group was 20.6 % ( p = 0.009 ) .\
RESULTS	No statistical difference was detected between the two groups in terms of lateral retinacular release-related complications ( n.s. ) , patients ' satisfaction ( n.s. ) , knee score ( n.s. ) , function score ( n.s. ) , and patellar score ( n.s. ) at 18 months follow-up .\
CONCLUSIONS	The present study suggests that routine lateral retinacular release can reduce anterior knee pain and does not increase lateral retinacular release-related complications , in TKA with the use of the Gemini MK II mobile bearing without patellar resurfacing .\
METHODS	Therapeutic , Level I.\
\
###17785984\
OBJECTIVE	The purse-string suture is the most important part of the procedure in stapled hemorrhoidopexy affecting resection of an ideal mucosal rectal ring .\
OBJECTIVE	We designed a prospective , randomized study to evaluate the safety and clinical outcome of a 6-stitch purse-string suture compared with a more simple 3-stitch purse-string suture intended to achieve certain interruption of the hemorrhoidal artery .\
METHODS	Ninety patients were randomly assigned to undergo stapled hemorrhoidopexy with either a 6-stitch ( n = 45 ) or a 3-stitch ( n = 45 ) purse-string suture .\
METHODS	Operative data and postoperative complications were compared between the 2 groups .\
METHODS	The ring of excised rectal mucosa was examined histologically .\
METHODS	Anal physiology was also assessed .\
RESULTS	Although there were no statistically significant differences in postoperative complication rates , histological analysis of the excised mucosa , or anorectal function between the 2 groups , the 3-stitch procedure was significantly superior to the 6-stitch procedure in terms of intraoperative hemostasis and operative time , especially in advanced surgery .\
CONCLUSIONS	Once the learning curve has been completed , a 3-stitch purse-string suture in stapled hemorrhoidopexy could be an alternative to the 6-stitch suture , with effective hemostasis and a shorter operative time .\
\
###25071075\
OBJECTIVE	To comprehensively compare the effects of a very low-carbohydrate , high-unsaturated/low-saturated fat diet ( LC ) with those of a high-unrefined carbohydrate , low-fat diet ( HC ) on glycemic control and cardiovascular disease ( CVD ) risk factors in type 2 diabetes ( T2DM ) .\
METHODS	Obese adults ( n = 115 , BMI 34.4 4.2 kg/m ( 2 ) , age 58 7 years ) with T2DM were randomized to a hypocaloric LC diet ( 14 % carbohydrate [ < 50 g/day ] , 28 % protein , and 58 % fat [ < 10 % saturated fat ] ) or an energy-matched HC diet ( 53 % carbohydrate , 17 % protein , and 30 % fat [ < 10 % saturated fat ] ) combined with structured exercise for 24 weeks .\
METHODS	The outcomes measured were as follows : glycosylated hemoglobin ( HbA1c ) , glycemic variability ( GV ; assessed by 48-h continuous glucose monitoring ) , antiglycemic medication changes ( antiglycemic medication effects score [ MES ] ) , and blood lipids and pressure .\
RESULTS	A total of 93 participants completed 24 weeks .\
RESULTS	Both groups achieved similar completion rates ( LC 79 % , HC 82 % ) and weight loss ( LC -12.0 6.3 kg , HC -11.5 5.5 kg ) ; P 0.50 .\
RESULTS	Blood pressure ( -9.8 / -7.3 11.6 / 6.8 mmHg ) , fasting blood glucose ( -1.4 2.3 mmol/L ) , and LDL cholesterol ( -0.3 0.6 mmol/L ) decreased , with no diet effect ( P 0.10 ) .\
RESULTS	LC achieved greater reductions in triglycerides ( -0.5 0.5 vs. -0.1 0.5 mmol/L ) , MES ( -0.5 0.5 vs. -0.2 0.5 ) , and GV indices ; P 0.03 .\
RESULTS	LC induced greater HbA1c reductions ( -2.6 1.0 % [ -28.4 10.9 mmol/mol ] vs. -1.9 1.2 % [ -20.8 13.1 mmol/mol ] ; P = 0.002 ) and HDL cholesterol ( HDL-C ) increases ( 0.2 0.3 vs. 0.05 0.2 mmol/L ; P = 0.007 ) in participants with the respective baseline values HbA1c > 7.8 % ( 62 mmol/mol ) and HDL-C < 1.29 mmol/L .\
CONCLUSIONS	Both diets achieved substantial improvements for several clinical glycemic control and CVD risk markers .\
CONCLUSIONS	These improvements and reductions in GV and antiglycemic medication requirements were greatest with the LC compared with HC .\
CONCLUSIONS	This suggests an LC diet with low saturated fat may be an effective dietary approach for T2DM management if effects are sustained beyond 24 weeks .\
\
###14746625\
BACKGROUND	Griseofulvin has been the mainstay of treatment for tinea imbricata ( TI ) for decades ; however , there have been few reports of efficacy of newer antifungals in the treatment of this condition .\
BACKGROUND	Many patients with TI have several obstacles to treatment due to their remote geographical locations and the primitive nature of their societies .\
OBJECTIVE	The aim of this study was to compare the efficacy of itraconazole , terbinafine and fluconazole with that of griseofulvin after 4 weeks of therapy .\
METHODS	Patients aged 12-76 years with the clinical diagnosis of TI were randomly assigned to one of four treatment groups : griseofulvin 500 mg twice daily for 4 weeks , terbinafine 250 mg daily for 4 weeks , itraconazole 200 mg twice daily for 1 week or fluconazole 200 mg once weekly for 4 weeks .\
METHODS	Disease activity was monitored weekly .\
METHODS	Laboratory measurements included monitoring complete blood count and liver function enzymes .\
METHODS	Fifty-nine patients were included in the efficacy analysis : 13 in the fluconazole group , 15 in the griseofulvin group , 12 in the terbinafine group and 19 in the itraconazole group .\
RESULTS	Significant remission was achieved in the terbinafine and griseofulvin groups , lasting up to 8 weeks after cessation of therapy .\
RESULTS	The fluconazole group experienced no significant remission , and remission was of short duration in the itraconazole group .\
RESULTS	No adverse events were reported , and non-compliance with medications or follow-up was the only reason for removal from the study .\
CONCLUSIONS	Griseofulvin and terbinafine are effective in the treatment of TI .\
CONCLUSIONS	The decision of whether to treat at all and which medication to choose depends greatly on the extent of involvement , the social situation , and the availability of resources such as laboratory testing and follow-up .\
\
###25996273\
OBJECTIVE	Optimization of glycemic control is critical to reduce the number of diabetes mellitus-related complications , but long-term success is challenging .\
OBJECTIVE	Although vision loss is among the greatest fears of individuals with diabetes , comprehensive personalized diabetes education and risk assessments are not consistently used in ophthalmologic settings .\
OBJECTIVE	To determine whether the point-of-care measurement of hemoglobin A ( 1c ) ( HbA ( 1c ) ) and personalized diabetes risk assessments performed during retinal ophthalmologic visits improve glycemic control as assessed by HbA ( 1c ) level .\
METHODS	Ophthalmologist office-based randomized , multicenter clinical trial in which investigators from 42 sites were randomly assigned to provide either a study-prescribed augmented diabetes assessment and education or the usual care .\
METHODS	Adults with type 1 or 2 diabetes enrolled into 2 cohorts : those with a more-frequent-than-annual follow-up ( 502 control participants and 488 intervention participants ) and those with an annual follow-up ( 368 control participants and 388 intervention participants ) .\
METHODS	Enrollment was from April 2011 through January 2013 .\
METHODS	Point-of-care measurements of HbA1c , blood pressure , and retinopathy severity ; an individualized estimate of the risk of retinopathy progression derived from the findings from ophthalmologic visits ; structured comparison and review of past and current clinical findings ; and structured education with immediate assessment and feedback regarding participant 's understanding .\
METHODS	These interventions were performed at enrollment and at routine ophthalmic follow-up visits scheduled at least 12 weeks apart .\
METHODS	Mean change in HbA ( 1c ) level from baseline to 1-year follow-up .\
METHODS	Secondary outcomes included body mass index , blood pressure , and responses to diabetes self-management practices and attitudes surveys .\
RESULTS	In the cohort with more-frequent-than-annual follow-ups , the mean ( SD ) change in HbA ( 1c ) level at 1 year was -0.1 % ( 1.5 % ) in the control group and -0.3 % ( 1.4 % ) in the intervention group ( adjusted mean difference , -0.09 % [ 95 % CI , -0.29 % to 0.12 % ] ; P = .35 ) .\
RESULTS	In the cohort with annual follow-ups , the mean ( SD ) change in HbA ( 1c ) level was 0.0 % ( 1.1 % ) in the control group and -0.1 % ( 1.6 % ) in the intervention group ( mean difference , -0.05 % [ 95 % CI , -0.27 % to 0.18 % ] ; P = .63 ) .\
RESULTS	Results were similar for all secondary outcomes .\
CONCLUSIONS	Long-term optimization of glycemic control is not achieved by a majority of individuals with diabetes .\
CONCLUSIONS	The addition of personalized education and risk assessment during retinal ophthalmologic visits did not result in a reduction in HbA ( 1c ) level compared with usual care over 1 year .\
CONCLUSIONS	These data suggest that optimizing glycemic control remains a substantive challenge requiring interventional paradigms other than those examined in our study .\
BACKGROUND	clinicaltrials.gov Identifier : NCT01323348 .\
\
###24650076\
BACKGROUND	Numerous studies indicate that the use of feeding tubes ( FT ) in persons with advanced cognitive impairment ( CI ) does not improve clinical outcomes or survival , and results in higher rates of hospitalization and emergency department ( ED ) visits .\
BACKGROUND	It is not clear , however , whether such risk varies by resident level of CI and whether these ED visits and hospitalizations are potentially preventable .\
BACKGROUND	The objective of this study was to determine the rates of ED visits , hospitalizations and potentially preventable ambulatory care sensitive ( ACS ) ED visits and ACS hospitalizations for long-stay NH residents with FTs at differing levels of CI .\
METHODS	We linked Centers for Medicare and Medicaid Services inpatient & outpatient administrative claims and beneficiary eligibility data with Minimum Data Set ( MDS ) resident assessment data for nursing home residents with feeding tubes in a 5 % random sample of Medicare beneficiaries residing in US nursing facilities in 2006 ( n = 3479 ) .\
METHODS	Severity of CI was measured using the Cognitive Performance Scale ( CPS ) and categorized into 4 groups : None/Mild ( CPS = 0-1 , MMSE = 22-25 ) , Moderate ( CPS = 2-3 , MMSE = 15-19 ) , Severe ( CPS = 4-5 , MMSE = 5-7 ) and Very Severe ( CPS = 6 , MMSE = 0-4 ) .\
METHODS	ED visits , hospitalizations , ACS ED visits and ACS hospitalizations were ascertained from inpatient and outpatient administrative claims .\
METHODS	We estimated the risk ratio of each outcome by CI level using over-dispersed Poisson models accounting for potential confounding factors .\
RESULTS	Twenty-nine percent of our cohort was considered `` comatose '' and `` without any discernible consciousness '' , suggesting that over 20,000 NH residents in the US with feeding tubes are non-interactive .\
RESULTS	Approximately 25 % of NH residents with FTs required an ED visit or hospitalization , with 44 % of hospitalizations and 24 % of ED visits being potentially preventable or for an ACS condition .\
RESULTS	Severity of CI had a significant effect on rates of ACS ED visits , but little effect on ACS hospitalizations .\
CONCLUSIONS	ED visits and hospitalizations are common in cognitively impaired tube-fed nursing home residents and a substantial proportion of ED visits and hospitalizations are potentially preventable due to ACS conditions .\
\
###23978529\
OBJECTIVE	To investigate whether kinesiotaping improves excessive foot pronation compared with sham kinesiotaping .\
METHODS	Quasi-randomised , double-blind study .\
METHODS	One primary care centre .\
METHODS	One hundred and thirty participants were screened for inclusion .\
METHODS	Sixty-eight participants with pronated feet [ Foot Posture Index ( FPI ) 6 ] were enrolled , and the follow-up rate was 100 % .\
METHODS	Participants were allocated into one of two groups : an experimental kinesiotaping group ( KT1 ) and a sham taping group ( KT2 ) .\
METHODS	Measures were collected by a blinded assessor at baseline , and 1 minute , 10 minutes , 60 minutes and 24 hours after taping .\
METHODS	The primary outcome was total FPI score , and the secondary outcome was rear-foot FPI score .\
RESULTS	There were no significant differences in total FPI score between kinesiotaping and sham taping at any time point .\
RESULTS	Similarly , there were no significant differences in rear-foot FPI score , apart from at 60-minute follow-up when the difference between groups was significant ( P = 0.04 ) but the effect size was very small ( 0.85 points on the rear-foot FPI score between -6 and +6 ) .\
CONCLUSIONS	Kinesiotaping does not correct foot pronation compared with sham kinesiotaping in people with pronated feet .\
\
###12504048\
OBJECTIVE	To determine whether breast pain affects quality of life ( QOL ) after breast-conserving surgery and tamoxifen ( TAM ) with or without adjuvant breast radiotherapy ( RT ) .\
METHODS	A randomized clinical trial was carried out at the Princess Margaret Hospital between 1992 and 2000 to evaluate the need for breast RT in addition to TAM in women > or = 50 years treated with breast-conserving surgery for T1-T2N0 breast cancer .\
METHODS	A companion study to assess breast pain was carried out during the last 2 years of the randomized clinical trial .\
METHODS	The short-form McGill Pain Questionnaire ( SF-MPQ ) , the European Organization for Research and Treatment of Cancer ( EORTC ) QOL ( QLQ-C30 ) and EORTC breast cancer module ( QLQ-BR23 ) questionnaires were completed by patients within 1 week of randomization in the randomized clinical trial ( baseline ) and at 3 , 6 , and 12 months .\
RESULTS	Eighty-six patients participated in the breast pain study ; 41 received RT plus TAM and 45 received TAM alone .\
RESULTS	The median age was 70 years ( range 51-80 ) .\
RESULTS	The baseline pain and QOL scores were similar for the two groups .\
RESULTS	No significant difference was found between the two groups for each scale of the QLQ-C30 and QLQ-BR23 questionnaires at 3 , 6 , or 12 months ( p > 0.100 ) , except that at 12 months , the score for role function ( QLQ-C30 ) was higher in the RT plus TAM group than in the RT-only group ( p = 0.02 ) .\
RESULTS	At 3 months , the difference between the mean scores for the SF-MPQ was 0.553 ( p = 0.47 ) .\
RESULTS	At 12 months , the pain scores had decreased in both groups ; the difference was 0.199 ( p = 0.71 ) .\
RESULTS	The number of breast operations or surgical complications did not correlate with breast pain in either group .\
RESULTS	Acute RT toxicity scores did not correlate with breast pain or QOL scores at 12 months .\
CONCLUSIONS	These results suggest that breast RT does not significantly contribute to breast pain or adversely impact the QOL up to 12 months after treatment in postmenopausal patients with node-negative breast cancer who take TAM .\
\
###15130715\
OBJECTIVE	The aim of this study was the assessment of visual biofeedback in the management of balance disorders after stroke .\
METHODS	This is a prospective randomised trial , which compares visual biofeedback training and traditional balance training .\
METHODS	Twenty-seven patients took part in this study : 13 in the first group and 14 in the second group .\
METHODS	The rehabilitation program in the first group consists in an association of visual biofeedback and traditional training during 3 weeks .\
METHODS	For the second group traditional training was used alone .\
METHODS	Clinical , functional and forceplate assessments were performed before and after the program of rehabilitation .\
RESULTS	All the patients had a clinical and functional improvement .\
RESULTS	However , patients who have benefited from biofeedback training had a significant improvement of the forceplate parameters with closed eyes .\
CONCLUSIONS	Those results confirm the interest of rehabilitation in balance disorders after stroke .\
CONCLUSIONS	The use of biofeedback training incorporated into functional physiotherapy affords added benefits probably by a best integration of proprioceptive informations .\
\
###15477504\
BACKGROUND	Intravenous immunoglobulin ( IVIg ) has been reported to reduce disease activity in patients with relapsing-remitting multiple sclerosis .\
BACKGROUND	We assessed the effect of IVIg treatment in patients after the first neurological event suggestive of demyelinative disease and evaluated the occurrence of a second attack and dissemination in time demonstrated by brain magnetic resonance imaging within the first year from onset .\
METHODS	We conducted a randomized , placebo-controlled , double-blind study in 91 eligible patients enrolled within the first 6 weeks of neurological symptoms .\
METHODS	Patients were randomly assigned to receive IVIg treatment ( 2-g/kg loading dose ) or placebo , with boosters ( 0.4 g/kg ) given once every 6 weeks for 1 year .\
METHODS	Neurological and clinical assessments were done every 3 months , and brain magnetic resonance imaging was performed at baseline and the end of the study .\
RESULTS	The cumulative probability of developing clinically definite multiple sclerosis was significantly lower in the IVIg treatment group compared with the placebo group ( rate ratio , 0.36 [ 95 % confidence interval , 0.15-0 .88 ] ; P = .03 ) .\
RESULTS	Patients in the IVIg treatment group had a significant reduction in the volume and number of T2-weighted lesions and in the volume of gadolinium-enhancing lesions as compared with the placebo group ( P = .01 , P = .01 , and P = .03 , respectively ) .\
RESULTS	Treatment was well tolerated , compliance was high , and incidence of adverse effects did not differ significantly between groups .\
CONCLUSIONS	Intravenous immunoglobulin treatment for the first year from onset of the first neurological event suggestive of demyelinative disease significantly lowers the incidence of a second attack and reduces disease activity as measured by brain magnetic resonance imaging .\
\
###22204173\
OBJECTIVE	To see the efficacy of Transcutaneous Electrical Nerve Stimulation therapy and its different modes in trigeminal neuralgia , refractory or partially responsive to drug therapy and to find out the comparative effectiveness of different modes of TENS therapy in these cases .\
METHODS	This was a prospective analytical study , conducted at Rabia Moon Institute of Neurological Sciences over a period of one year .\
METHODS	Thirty one patients diagnosed as suffering from trigeminal neuralgia according to International Headache Society Criteria , either Classic Trigeminal Neuralgia ( CTN ) or Symptomatic Trigeminal Neuralgia ( STN ) were randomly subjected to two different modes of Transcutaneous Electrical Nerve Stimulation ( TENS ) therapy .\
METHODS	Severity of pain was assessed on visual analogue scale prior to treatment and fifteen days after therapy and results were than compared .\
RESULTS	Out of 31 patients , 20 females and 11 males , with a mean age of 50.1 + / - 11 years , 26 ( 83.7 % ) improved significantly with application of TENS , only 5 ( 16.3 % ) patients remained unresponsive to this form of therapy .\
RESULTS	Study also showed a better efficacy of constant mode of therapy over burst mode .\
CONCLUSIONS	Transcutaneous electrical nerve stimulation is an effective , easy to use therapy with minimal side effects in patients suffering from trigeminal neuralgia not responding to conventional treatment .\
CONCLUSIONS	Constant mode of this therapy was a slightly better option than burst mode therapy .\
\
###25168918\
BACKGROUND	Despite administration of annual influenza vaccination , influenza-associated complications in transplant recipients continue to be an important cause of hospitalization and death .\
BACKGROUND	Although influenza vaccination has been proven to be the most effective measure to reduce influenza infection after transplantation , transplant recipients are still vulnerable to influenza infections , with lower serological responses to vaccination compared to the general population .\
BACKGROUND	In order to assess the efficacy and safety of an alternative immunization scheme for solid organ transplant recipients , the TRANSGRIPE1-2 Study Group aimed to test a booster dose administration 5 weeks after the standard vaccination .\
BACKGROUND	The primary objective of this trial was to compare short-term and long-term neutralizing antibody immunogenicity of a booster dose of influenza vaccination to the standard single-dose immunization scheme .\
BACKGROUND	Secondary objectives included the evaluation of the efficacy and/or safety , cellular immune response , incidence of influenza infection , graft rejection , retransplant and mortality rates .\
METHODS	This phase III , randomized , controlled , open-label clinical trial was conducted between October 2012 and December 2013 in 12 Spanish public referral hospitals .\
METHODS	Solid organ transplant recipients ( liver , kidney , heart or lung ) , older than 16 years of age more than 30 days after transplantation were eligible to participate .\
METHODS	Patients ( N = 514 ) were stratified 1:1 by center , type of organ and time after transplantation and who either received the standard single dose ( n = 257 ) or were treated according to a novel influenza vaccination schedule comprising the administration of a booster dose 5 weeks after standard vaccination ( n = 254 ) .\
METHODS	Seroconversion rates were measured as a determinant of protection against influenza ( main outcome ) .\
METHODS	Efficacy and safety outcomes were followed until 1 year after influenza vaccination with assessment of short-term ( 0 , 5 , 10 and 15 weeks ) and long-term ( 12 months ) results .\
METHODS	Intention-to-treat , per-protocol and safety analyses will be performed .\
CONCLUSIONS	This trial will increase knowledge about the safety and efficacy of a booster dose of influenza vaccine in solid organ transplant recipients .\
CONCLUSIONS	At the time the manuscript was submitted for publication , trial recruitment was closed with a total of 499 participants included during a 2-month period ( within the seasonal influenza vaccination campaign ) .\
BACKGROUND	ClinicalTrials.gov Identifier : NCT01761435 ( registered 13 December 2012 ) .\
BACKGROUND	EudraCT Identifier : 2011-003243-21 ( registered 4 July 2011 ) .\
\
###23901266\
BACKGROUND	Older adults often use complementary medicine ; however , very few interventional studies have focused on them .\
BACKGROUND	The aim of this study was to evaluate the feasibility and to obtain preliminary data on effectiveness of an Integrative Medicine ( IM ) program compared to usual medical care .\
METHODS	The study consisted of older adults living in shared apartment communities including caregiving .\
METHODS	The shared apartments were cluster-randomized to the IM program or Usual Care ( UC ) .\
METHODS	IM consisted of additional lifestyle modification ( exercise and diet ) , external naturopathic applications , homeopathic treatment , and modification of conventional drug therapy for 12 months .\
METHODS	The UC group received conventional care alone .\
METHODS	The following outcomes were used : Nurses Observation Scale for Geriatric Patients ( NOSGER ) ; Assessment of Motor and Process Skills ; Barthel Index ; Qualidem ; Profile of Wellbeing ; and Mini-mental State Examination .\
METHODS	Exploratory effect sizes ( Cohen 's d , means adjusted for differences of baseline values ) were calculated to analyze group differences .\
RESULTS	A total of eight shared apartment communities were included ; four were allocated to IM ( 29 patients , median seven patients ; [ mean standard deviation ] 82.7 8.6 years ) and four to UC ( 29 patients , median eight patients ; 76.0 12.8 years of age ) .\
RESULTS	After 12 months , effect sizes 0.3 were observed for activities of daily living on the NOSGER-Activities of Daily Living subscale ( 0.53 ) , Barthel Index ( 0.30 ) , Qualidem total sum score ( 0.39 ) , Profile of Wellbeing ( 0.36 ) , NOSGER-Impaired Social Behavior ( 0.47 ) , and NOSGER-Depressed Mood subscales ( 0.40 ) .\
RESULTS	Smaller or no effects were observed for all other outcomes .\
RESULTS	The intervention itself was found to be feasible , but elaborate and time consuming .\
CONCLUSIONS	This exploratory pilot study showed that for a full-scale trial , the outcomes of Activities of Daily Living and Quality of Life seem to be the most promising .\
CONCLUSIONS	The results have to be interpreted with care ; larger confirmatory trials are necessary to validate the effects .\
\
###23493565\
BACKGROUND	The NOSCAR white paper lists training as an important step to the safe clinical application of natural orifice translumenal endoscopic surgery ( NOTES ) .\
BACKGROUND	The aim of this randomized controlled trial was to evaluate whether training novices in either a laparoscopic or endoscopic simulator curriculum would affect performance in a NOTES simulator task .\
METHODS	A total of 30 third-year medical undergraduates were recruited .\
METHODS	They were randomized to 3 groups : no training ( control ; n = 10 ) , endoscopy training on a validated colonoscopy simulator protocol ( n = 10 ) , and training on a validated laparoscopy simulator curriculum ( n = 10 ) .\
METHODS	All participants subsequently completed a simulated NOTES task , consisting of 7 steps , on the ELITE ( endoscopic-laparoscopic interdisciplinary training entity ) model .\
METHODS	Performance was assessed as time taken to complete individual steps , overall task time , and number of errors .\
RESULTS	The endoscopy group was significantly faster than the control group at accessing the peritoneal cavity through the gastric incision ( median 27 vs 78 s ; P = .015 ) , applying diathermy to the base of the appendix ( median 103.5 vs 173 s ; P = .014 ) , and navigating to the gallbladder ( median 76 vs 169.5 s ; P = .049 ) .\
RESULTS	Endoscopy participants completed the full NOTES procedure in a shorter time than the laparoscopy group ( median 863 vs 2074 s ; P < .001 ) .\
CONCLUSIONS	This study highlights the importance of endoscopic training for a simulated NOTES task that involves both navigation and resection with operative maneuvers .\
CONCLUSIONS	Although laparoscopic training confers some benefit for operative steps such as applying diathermy to the gallbladder fossa , this was not as beneficial as training in endoscopy .\
\
###12975660\
OBJECTIVE	The authors present the Hungarian interim analysis and experience with the BCIRG 001 randomized , multicentric , phase III clinical trial comparing TAC ( docetaxel , doxorubicin , cyclophosphamide ) and FAC ( 5-fluorouracil , doxorubicin , cyclophosphamide ) in the adjuvant treatment of node positive breast cancer patients .\
OBJECTIVE	The results are presented according to international data .\
METHODS	Three Hungarian centers - St. Margit Hospital , Budapest , National Institute of Oncology , Budapest , Petz Aladr Hospital , Gyr - participated in the international trial .\
METHODS	Between June 1997 and June 1999 , 61 patients with node positive breast cancer were enrolled in the study after the surgery .\
METHODS	Thirty-four patients were randomized to TAC ( 75/50/500 mg/m2 6x q3wk ) and 27 patients were randomized to FAC ( 500/50/500 mg/m2 6x q3wk ) chemotherapy , with prospective stratification by node ( 1-3 , 4 + ) .\
METHODS	In the case of patients with ER and/or PR positive tumours 5 years tamoxifen treatment was started .\
METHODS	Radiotherapy was performed after the 6th cycle of chemotherapy .\
RESULTS	36 months of follow up was performed .\
RESULTS	In both arms the hematological toxicity was more frequent .\
RESULTS	The TAC group showed a higher incidence of neutropenia ( 76 % ) compared to the FAC ( 22 % ) , as well as a higher incidence of febrile neutropenia ( 26 % ) , without grade 3-4 infection and there were no cases of septic death .\
RESULTS	Regarding non-hematological toxicity more grade 3-4 nausea and vomiting was observed in the FAC group .\
RESULTS	At three years follow up , the international results show statistically significant improvement in disease-free survival ( 82 % vs. 74 % , p = 0.0011 ) in favour of TAC , and similar tendency was observed in the case of overall survival ( 92 % vs. 87 % , p = 0.11 ) .\
RESULTS	This benefit with TAC was seen regardless of hormone receptor status .\
RESULTS	Due to the low number of Hungarian patients we can not declare the same results .\
CONCLUSIONS	Based on the international analysis TAC was superior to FAC chemotherapy .\
CONCLUSIONS	Additional follow up data will evaluate the role of TAC in the adjuvant setting of early breast cancer treatment .\
CONCLUSIONS	The results indicate that TAC has the potential to be incorporated in the new strategies of adjuvant breast cancer treatments .\
\
###11844944\
BACKGROUND	In this study the effects of treatment with cognitive therapy , antidepressants or pill-placebo on the locus of control orientation in panic disorder patients were analysed , as well as the relation of this panic locus of control with panic frequency and cognitive measures of panic .\
METHODS	A Multidimensional Anxiety Locus of Control scale ( MALC ) was developed and completed with other measures ( ACQ and BSQ ) before and after treatment .\
METHODS	Patients also kept a panic diary .\
RESULTS	Four subscales were derived from the MALC : one Internal , and three external ( a Chance , a Medication , and a Therapist ) locus of anxiety control orientation scales .\
RESULTS	Cognitive therapy was superior over pill-placebo on most outcome measures whereas antidepressants were only superior in reducing the number of panic attacks .\
RESULTS	Treatment with cognitive therapy resulted in an increase of ` internal ' anxiety control orientation and a decrease of ` chance ' and ` medication ' orientation , in comparison with antidepressant therapy .\
RESULTS	The residualized gain scores on the MALC subscales correlated with clinical improvement in subjects treated with cognitive therapy only .\
CONCLUSIONS	Results suggest that the locus of control orientation is important in evaluating the differential effects of treatments in panic disorder .\
CONCLUSIONS	A differential effect on panic locus of control in favor of cognitive therapy in comparison to medication was found .\
\
###15082464\
OBJECTIVE	To compare two levels of psychosocial intervention in combination with acamprosate medication for the treatment of alcohol dependence .\
METHODS	Patients ( n = 70 ) were prescribed acamprosate and randomized to Minimal Psychosocial Intervention ( MPI ) or Extended Psychosocial Intervention ( EPI ) .\
METHODS	MPI patients met a psychiatrist for 20-30 min sessions on four occasions during a 6 month period .\
METHODS	EPI patients were offered 10-15 sessions with a psychiatric nurse in addition to the visits to the psychiatrist .\
METHODS	EPI patients were trained to use behavioural and cognitive coping skills to deal with high-risk situations in line with a manual developed for relapse prevention .\
METHODS	Patients were assessed four times during the 24-week study by self-report and laboratory tests .\
RESULTS	Patients on average reported a decline in days with heavy drinking and in cumulative number of drinking days .\
RESULTS	No significant differences between patients in MPI and EPI were found with respect to heavy drinking , cumulative number of drinking days , number of days to first drink , or biomarkers of alcohol consumption .\
RESULTS	Higher age and lower level of education were significant predictors of treatment success .\
CONCLUSIONS	Adding more intensive individual treatments appears to add no extra improvement beyond that obtained by prescribing acamprosate and offering an infrequent consultation with a physician .\
\
###21197501\
OBJECTIVE	The primary goal of this study was to compare implant survival 12 months after immediate loading of single implants placed in healed ridges versus extraction sockets .\
OBJECTIVE	Secondary outcomes were to compare marginal bone adaptation and soft tissue changes over time .\
METHODS	A prospective multicenter clinical investigation was initiated to assess clinical performance of immediately loaded implants in the maxilla .\
METHODS	Implant survival was ascertained at the time of impression making ( 8 to 10 weeks ) and after 1 year by clinical stability .\
METHODS	Radiographic marginal bone levels , soft tissue levels , and plaque and bleeding scores were compared with baseline values ( implant placement and provisionalization ) .\
RESULTS	One hundred thirty-nine patients received 157 implants in the maxilla .\
RESULTS	Single implants with provisional crowns were placed in extraction sockets of 55 patients ( 58 implants ) and in healed ridges of 60 patients ( 65 implants ) .\
RESULTS	In addition , 19 patients ( 23 implants ) required bone grafting prior to implant placement , and 11 implants in 10 patients among all groups were not immediately loaded because of insufficient initial stability after surgery .\
RESULTS	Three implants ( 5.2 % ) failed in extraction sites and one implant ( 1.5 % ) failed in a healed ridge .\
RESULTS	The mean change in marginal bone level 1 year after implant placement was 1.30 mm ( SD 2.52 ) ( gain ) in extraction sockets and -0.40 mm ( SD 1.43 ) ( loss ) in healed ridges .\
RESULTS	The mucosal zenith was stable or moved incisally following definitive crown placement in 83.7 % of immediate implants and 87.0 % of implants placed in healed ridges .\
RESULTS	Plaque and inflammation scores were low and did not differ between groups .\
CONCLUSIONS	The responses of local bone and soft tissues at immediately loaded implants placed in extraction sockets or healed ridges were similar .\
CONCLUSIONS	Furthermore , these 1-year results suggest that clinical management of esthetically critical soft tissue may be predictably achieved in both indications .\
\
###23448122\
BACKGROUND	Laparoscopic cholecystectomy at standard-pressure pneumoperitoneum uses a pressure of 12-14 mm Hg , which may cause a variety of adverse physiological changes involving the respiratory , cardiovascular , and hepatorenal systems reflected as subclinical abnormalities in biochemical parameters .\
BACKGROUND	The use of low-pressure pneumoperitoneum in the range of 8-10 mm Hg has been shown to reduce the adverse physiological changes without affecting the outcome of surgery .\
METHODS	This study was done in a randomized controlled manner .\
METHODS	Patients with gallstone disease ( n = 101 ) underwent laparoscopic cholecystectomy .\
METHODS	Patients were randomly assigned to high-pressure laparoscopic cholecystectomy ( HPLC ) ( n = 51 ) and low-pressure laparoscopic cholecystectomy ( LPLC ) ( n = 50 ) and underwent surgery at pressures of 14 mm Hg and 8 mm Hg , respectively .\
METHODS	Liver function tests , including total bilirubin , alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) , and alkaline phosphatase , were obtained preoperatively and on postoperative Days 1 and 7 .\
RESULTS	The two study groups had similar demographic profiles , and there were no significant differences in the operative time ( HPLC , 47.25 6.73 minutes ; LPLC , 48.00 7.76 minutes ; P = .6071 ) and pneumoperitoneum time ( HPLC , 34.02 5.29 minutes ; LPLC , 34.60 6.13 minutes ; P = .6115 ) .\
RESULTS	On postoperative Day 1 , the total bilirubin levels were 1.0684 0.4108 mg/dL and 0.8926 0.3162 mg/dL for HPLC and LPLC ( P = .0179 ) , respectively , AST levels were 66.0810 25.5868 IU/L and 42.2420 14.7301 IU/L ( P = .0001 ) , respectively , and ALT levels were 68.1410 31.4572 IU/L and 42.7460 17.9405 IU/L ( P = .0001 ) , respectively .\
RESULTS	Thus , liver enzyme activities were significantly elevated in the HPLC group compared with the LPLC group .\
CONCLUSIONS	LPLC causes less abnormality in liver function tests in the postoperative period compared with HPLC .\
CONCLUSIONS	LPLC should be considered in all patients undergoing laparoscopic cholecystectomy , especially those patients with compromised liver functions .\
\
###10669989\
OBJECTIVE	Few data exist on the treatment of Helicobacter pylori infection in cirrhotic patients .\
OBJECTIVE	In this study we assessed the efficacy of standard dual and one-week low-dose triple therapy on Helicobacter pylori eradication in cirrhotics .\
METHODS	In a prospective study , 83 cirrhotic patients with epigastric pain were randomised to receive either a two-week course of dual therapy , composed of omeprazole 20 mg b.d. plus amoxycillin 1 g b.d. ( n = 41 ) or a one-week course of triple therapy , composed of omeprazole 20 mg b.d. , clarithromycin 250 mg b.d. , and tetracycline 500 mg b.d ( n = 42 ) .\
METHODS	Helicobacter pylori infection at entry and eradication 6-8 weeks after the end of therapy were assessed by rapid urease test and histology on biopsies from the antrum and corpus .\
METHODS	When eradication did not occur with either dual or triple therapy , patients were given the alternative regimen .\
METHODS	Helicobacter pylori eradication in these patients was assessed 6-8 weeks after the end of treatment by a further endoscopy .\
RESULTS	Helicobacter pylori eradication was achieved in 87.8 % ( 36 out of 41 ; 95 % confidence interval 77.8-97 .8 % ) of patients after dual therapy and in 85.7 % ( 36 out of 42 ; 95 % confidence interval 75.1-96 .3 % ) of patients treated with triple therapy ( p = NS ) .\
RESULTS	In patients in whom initial eradication was unsuccessful , re-treatment eradicated Helicobacter pylori in 4 out of 5 patients given the triple regimen and in all 5 patients who received the dual therapy .\
RESULTS	One patient was lost to follow-up .\
RESULTS	No major side-effects were reported for either treatment regimen .\
CONCLUSIONS	Our data show that both dual and triple therapies are effective in Helicobacter pylori eradication in cirrhotics as well as in eradication failure patients .\
CONCLUSIONS	Therefore , the use of the dual therapy regimen is strongly suggested as an initial treatment for Helicobacter pylori eradication in cirrhotic patients .\
\
###16376092\
OBJECTIVE	The purpose of this study was to evaluate whether intracoronary shunt usage reduced the myocardial damage on the basis of the cardiac markers when compared with the shuntless anastomosis in off-pump coronary artery bypass grafting ( OPCABG ) surgery of isolated left anterior descending artery lesions .\
METHODS	Forty patients who had stable angina with isolated left anterior descending ( LAD ) coronary artery lesion undergoing OPCABG surgery were randomized into two groups .\
METHODS	Shunt group consisted of 20 patients who had OPCABG using intracoronary shunt , whereas the shuntless group consisted of 20 patients who underwent OPCABG without using intracoronary shunt .\
METHODS	Cardiac troponin I , CK , and CK-MB before and 24h after the surgery were assessed in the groups .\
RESULTS	There were no deaths in the study .\
RESULTS	The two groups were similar with respect to sex and age .\
RESULTS	Duration of LIMA-LAD anastomosis was significantly higher in the shunt group ( p = 0.01 ) .\
RESULTS	There was no significant difference between the groups concerning the preoperative and postoperative CK and CK-MB levels .\
RESULTS	The preoperative troponin I levels of the groups were not different ( p = 0.238 ; NS ) , whereas postoperative levels of this marker was significantly higher in the shuntless group ( p = 0.003 ) .\
CONCLUSIONS	Intracoronary shunt reduced the postoperative troponin I levels significantly , so it may be indicated in the patients who are thought to be susceptible to transient ischemia .\
\
###20861065\
OBJECTIVE	To investigate the neuronal basis for the effects of mirror therapy in patients with stroke .\
METHODS	22 patients with stroke participated in this study .\
METHODS	The authors used functional MRI to investigate neuronal activation patterns in two experiments .\
METHODS	In the unimanual experiment , patients moved their unaffected hand , either while observing it directly ( no-mirror condition ) or while observing its mirror reflection ( mirror condition ) .\
METHODS	In the bimanual experiment , patients moved both hands , either while observing the affected hand directly ( no-mirror condition ) or while observing the mirror reflection of the unaffected hand in place of the affected hand ( mirror condition ) .\
METHODS	A two-factorial analysis with movement ( activity vs rest ) and mirror ( mirror vs no mirror ) as main factors was performed to assess neuronal activity resultant of the mirror illusion .\
RESULTS	Data on 18 participants were suitable for analysis .\
RESULTS	Results showed a significant interaction effect of movementmirror during the bimanual experiment .\
RESULTS	Activated regions were the precuneus and the posterior cingulate cortex ( p < 0.05 false discovery rate ) .\
CONCLUSIONS	In this first study on the neuronal correlates of the mirror illusion in patients with stroke , the authors showed that during bimanual movement , the mirror illusion increases activity in the precuneus and the posterior cingulate cortex , areas associated with awareness of the self and spatial attention .\
CONCLUSIONS	By increasing awareness of the affected limb , the mirror illusion might reduce learnt non-use .\
CONCLUSIONS	The fact that the authors did not observe mirror-related activity in areas of the motor or mirror neuron system questions popular theories that attribute the clinical effects of mirror therapy to these systems .\
\
###10021470\
BACKGROUND	Short-term administration of growth hormone to children with idiopathic short stature results in increases in growth rate and standard-deviation scores for height .\
BACKGROUND	However , the effect of long-term growth hormone therapy on adult height in these children is unknown .\
METHODS	We studied 121 children with idiopathic short stature , all of whom had an initial height below the third percentile , low growth rates , and maximal stimulated serum concentrations of growth hormone of at least 10 microg per liter .\
METHODS	The children were treated with growth hormone ( 0.3 mg per kilogram of body weight per week ) for 2 to 10 years .\
METHODS	Eighty of these children have reached adult height , with a bone age of at least 16 years in the boys and at least 14 years in the girls , and pubertal stage 4 or 5 .\
METHODS	The difference between the predicted adult height before treatment and achieved adult height was compared with the corresponding difference in three untreated normal or short-statured control groups .\
RESULTS	In the 80 children who have reached adult height , growth hormone treatment increased the mean standard-deviation score for height ( number of standard deviations from the mean height for chronologic age ) from -2.7 to -1.4 .\
RESULTS	The mean ( + / - SD ) difference between predicted adult height before treatment and achieved adult height was +5.0 + / -5.1 cm for boys and +5.9 + / -5.2 cm for girls .\
RESULTS	The difference between predicted and achieved adult height among treated boys was 9.2 cm greater than the corresponding difference among untreated boys with initial standard-deviation scores of less than -2 , and the difference among treated girls was 5.7 cm greater than the difference among untreated girls .\
CONCLUSIONS	Long-term administration of growth hormone to children with idiopathic short stature can increase adult height to a level above the predicted adult height and above the adult height of untreated historical control children .\
\
###21851643\
BACKGROUND	Aboriginal and Torres Strait Islander women have a higher prevalence and incidence of obesity and type 2 diabetes than non-Indigenous Australian women .\
BACKGROUND	Physical inactivity is a key modifiable risk factor for obesity and evidence shows that even modest reductions in waist circumference ( WC ) have significant health benefits .\
BACKGROUND	Trialing physical activity programs in difficult-to-reach high risk groups , especially urban Indigenous Australians poses distinct implementation challenges .\
METHODS	The trial objective is to evaluate the effectiveness of a structured 12-week physical activity group program with nutritional advice .\
METHODS	The design is a pragmatic randomised controlled trial .\
METHODS	This study protocol describes the implementation and evaluation of the program .\
METHODS	Participants are randomised into either an intervention or waitlisted group .\
METHODS	The waitlisted group have a 12 month waiting period before commencing the 12-week program .\
METHODS	Participant data is collected at baseline , 12 , 24 and 52 weeks .\
METHODS	Participants are Aboriginal and Torres Strait Islander women , aged 18-64 years with a waist circumference greater than 80 centimetres residing in Adelaide .\
METHODS	The primary outcome measure is WC change immediately post program from baseline .\
METHODS	Secondary outcomes include short term and long term changes in WC , weight , blood pressure , fasting blood glucose , insulin , insulin resistance ( calculated HOMA ) , haemoglobin A1C ( HbA1C ) , triglycerides and C-reactive protein ( CRP ) .\
METHODS	Behavioural and psychosocial surveys are administered to assess physical activity , dietary intake and the participant 's motivation , self-efficacy and perceived social support for physical activity .\
METHODS	Qualitative interviews focusing on participants ' motivation , enablers and barriers to healthy eating and physical activity will be undertaken .\
METHODS	Implementation fidelity and participation are also assessed .\
CONCLUSIONS	The Aboriginal and Torres Strait Islander Women 's Fitness Program ( WFP ) is designed to provide a rigorous physiological and client-based evaluation of a structured 12-week program aimed to increase metabolic fitness and reduce WC in this high risk population .\
CONCLUSIONS	Evaluation results aim to provide the support necessary to design programs that are accessible , affordable and effective at reducing WC , while also improving the metabolic profile of overweight Aboriginal and Torres Strait Islander women .\
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12610000224022 .\
\
###24622805\
BACKGROUND	Early nutrition is recognized as a target for the effective prevention of childhood obesity .\
BACKGROUND	Protein intake was associated with more rapid weight gain during infancy-a known risk factor for later obesity .\
OBJECTIVE	We tested whether the reduction of protein in infant formula reduces body mass index ( BMI ; in kg/m ( 2 ) ) and the prevalence of obesity at 6 y of age .\
METHODS	The Childhood Obesity Project was conducted as a European multicenter , double-blind , randomized clinical trial that enrolled healthy infants born between October 2002 and July 2004 .\
METHODS	Formula-fed infants ( n = 1090 ) were randomly assigned to receive higher protein ( HP ) - or lower protein ( LP ) - content formula ( within recommended amounts ) in the first year of life ; breastfed infants ( n = 588 ) were enrolled as an observational reference group .\
METHODS	We measured the weight and height of 448 ( 41 % ) formula-fed children at 6 y of age .\
METHODS	BMI was the primary outcome .\
RESULTS	HP children had a significantly higher BMI ( by 0.51 ; 95 % CI : 0.13 , 0.90 ; P = 0.009 ) at 6 y of age .\
RESULTS	The risk of becoming obese in the HP group was 2.43 ( 95 % CI : 1.12 , 5.27 ; P = 0.024 ) times that in the LP group .\
RESULTS	There was a tendency for a higher weight in HP children ( 0.67 kg ; 95 % CI : -0.04 , 1.39 kg ; P = 0.064 ) but no difference in height between the intervention groups .\
RESULTS	Anthropometric measurements were similar in the LP and breastfed groups .\
CONCLUSIONS	Infant formula with a lower protein content reduces BMI and obesity risk at school age .\
CONCLUSIONS	Avoidance of infant foods that provide excessive protein intakes could contribute to a reduction in childhood obesity .\
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00338689 .\
\
###24756903\
OBJECTIVE	To identify a molecular signature that could be predictive of the clinical response to rituximab ( RTX ) and elucidate the transcriptomic changes after RTX therapy in patients with rheumatoid arthritis ( RA ) , with the use of whole-blood transcriptomic profiling .\
METHODS	A microarray assay of the whole human genome was performed using RNA from peripheral blood samples obtained before the first cycle of RTX from 68 patients with RA in the SMART study .\
METHODS	The transcriptomic profile was also assessed 24 weeks after the first administration of RTX ( among 24 nonresponders and 44 responders , according to the European League Against Rheumatism response criteria at week 24 ) .\
METHODS	Ingenuity Interactive Pathways Analysis was used to identify molecular pathways that were modified by RTX therapy according to the clinical response .\
METHODS	Quantitative polymerase chain reaction was performed to confirm the microarray results .\
RESULTS	In total , 198 genes showed significant baseline differential expression between patient groups according to their subsequent response to RTX ( good or moderate responder versus nonresponder ) .\
RESULTS	This molecular signature could be reduced to 143 genes , which allowed for correctly classifying 89 % of the patients by their EULAR response status at week 24 , with 93 % identification of responders and 100 % identification of nonresponders .\
RESULTS	The signature for response featured up-regulation of inflammatory genes centered on NF-B , including IL33 and STAT5A , and down-regulation of the interferon pathway .\
RESULTS	As expected , at week 24 post-RTX therapy , genes involved in the development and functions of B cells were the genes most strongly down-regulated , without any difference between the 2 groups .\
CONCLUSIONS	Whole-blood transcriptomic analyses may accurately identify patients with RA who will not respond to RTX therapy .\
CONCLUSIONS	These findings could open new perspectives on the clinical management of RA .\
\
###24136677\
BACKGROUND	Surgery of lumbar disc herniations is one of the most common neurosurgical procedures .\
BACKGROUND	New surgical approaches and techniques are constantly evolving .\
BACKGROUND	We present our long-term follow-up results comparing standard open microdiscectomy ( SOMD ) and minimal access microdiscectomy ( MAMD ) for single-level lumbar disc herniations .\
METHODS	Patients were randomized in two groups receiving either MAMD or SOMD .\
METHODS	Physical and mental health and pain relief were assessed ( ODI , SF-36 questionnaire , VAS leg and back pain ) .\
METHODS	In addition , all patients received MR imaging for morphological evaluation of postoperative peridural scar tissue formation .\
RESULTS	Of the 60 initial patients ( SOMD : 30 pts , MAMD : 30 pts ) , 38 were available for long-term follow-up .\
RESULTS	Mean follow-up time was 33 months .\
RESULTS	Long-term follow-up revealed significant postoperative pain relief in both groups .\
RESULTS	Good to excellent results concerning physical and mental health and pain relief were achieved in both groups .\
RESULTS	Significantly less peridural scar tissue formation was observed in the MAMD patients , but without clinical impact .\
CONCLUSIONS	MAMD is a feasible alternative to the standard open approach .\
CONCLUSIONS	Both groups show significant and long-lasting pain relief and good to excellent results regarding health-related quality of life .\
CONCLUSIONS	Congruent to our short-term results , we observed slightly but not statistically significant better clinical results in the MAMD group when compared to the SOMD group .\
\
###20833391\
BACKGROUND	The use of meshes made with reabsorbable materials and structures that allow them to be fixed to the tissue without sutures , is considered as a therapeutic possibility in inguinal hernioplasty , reducing surgical times and supposedly improving pain and post-operative recovery .\
METHODS	A prospective randomised study of patients intervened for inguinal hernia between March 2009 and March 2010 .\
METHODS	Those patients subjected to hernia repair with a self-adhesive mesh ( Parietene Progrip ( ) ) were placed in the in the SA ( self-adhesive ) group , and those subjected to hernia repair with a polypropylene mesh fixed with a monofilament suture in the CL ( Classic Lichenstein ) group .\
METHODS	Complications and pain , using the visual analogue scale , were evaluated over 7 days .\
RESULTS	A total of 90 patients were divided into 2 groups of 45 .\
RESULTS	The mean age was 60 y and 49 years , respectively , with the mean size of the hernia defect being 3cm , and approximately 60 % were indirect hernias .\
RESULTS	The time of fixing the mesh and the overall surgery time was lower in the SA group than in the LC group : 56s versus 3min and 52s , and 17min and 45s versus 20min and 10s , respectively .\
RESULTS	There were no differences in hospital stay , complications or post-operative pain .\
CONCLUSIONS	The use of this type of mesh reduces the time of fixing the prosthesis and the total surgical time , with no effect on early post-operative pain or surgical complications compared to hernioplasty with a polypropylene mesh fixed with a monofilament suture .\
\
###11182175\
OBJECTIVE	To compare the effects on maximal exercise tolerance of 12 weeks of four dosages of telmisartan ( 10/20/40 / 80 mg once daily ) , an AT ( 1 ) specific angiotensin II receptor antagonist , or continuation on the angiotensin converting enzyme inhibitor enalapril , in patients with stable , mild-to-moderate congestive heart failure ( NYHA Class II and III and left ventricular ejection fraction < or = 40 % ) .\
METHODS	Multicenter , double-blind , parallel-group trial in 378 patients , randomized to once-daily treatment with telmisartan 10 , 20 , 40 mg , 80 mg , or continuation of enalapril 10 mg twice daily for 12 weeks .\
METHODS	Primary efficacy parameter : change from baseline to final visit in bicycle exercise duration .\
METHODS	Secondary efficacy parameters included left ventricular ejection fraction , quality-of-life parameters , arterial blood pressures , neurohormonal changes and NYHA classification .\
METHODS	The mean age of the patients was 64 + / -9 years , 89 % male , history of myocardial infarction in 68 % , NYHA-II : 63 % , NYHA-III : 37 % , ejection fraction 26.4 ( 7 ) % , and a reproducible impaired exercise capacity .\
METHODS	All patients were on diuretics and enalapril 10 mg twice daily , and 39 % were taking digitalis at study entry .\
RESULTS	No clinically relevant or statistically significant ( P < 0.05 ) differences were observed in the primary efficacy parameter : mean changes ( s ) in exercise tolerance were +8.6 , +8.2 , +2.2 , and +7.1 for the telmisartan 10 - , 20 - , 40 - , and 80-mg groups , respectively , and +1.4 for enalapril .\
RESULTS	There was a small but significant increase in blood pressure in all but the 80 mg telmisartan groups , compared to enalapril .\
RESULTS	Telmisartan and enalapril had comparable adverse event profiles .\
RESULTS	Cough occurred in 5.6 % of the enalapril patients and in 3 % of the telmisartan patients ( NS ) .\
CONCLUSIONS	( 1 ) In patients with stable , mild-to-moderate congestive heart failure , enalapril could be replaced by telmisartan for a period of 12 weeks without deterioration in exercise capacity or clinical status .\
CONCLUSIONS	( 2 ) No differences were observed in exercise capacity between the four dosages of telmisartan .\
\
###23549975\
BACKGROUND	Limited evidence exists as to the benefit of tonsillectomy in adult patients .\
BACKGROUND	We sought to determine the short-term efficacy of tonsillectomy for recurrent pharyngitis in adults .\
METHODS	We conducted a randomized , controlled , parallel-group trial at a tertiary care ear , throat and nose centre in Oulu , Finland , between October 2007 and December 2010 .\
METHODS	Adult patients with recurrent pharyngitis were randomly assigned to the control group ( watchful waiting ) or the tonsillectomy group .\
METHODS	Our primary outcome was the difference in the proportion of patients with severe pharyngitis ( severe symptoms and C-reactive protein level > 40 mg/L ) within 5 months .\
METHODS	Our secondary outcomes included differences between groups in proportions of patients who had episodes of pharyngitis with or without medical consultation , rates of pharyngitis and numbers of days with symptoms .\
RESULTS	Of 260 patients referred for tonsillectomy because of recurrent pharyngitis , we recruited 86 participants for our study .\
RESULTS	Of these , 40 patients were randomly allocated to the control group , and 46 were randomly allocated to the tonsillectomy group .\
RESULTS	One patient in the control group and no patients in the tonsillectomy group had a severe episode of pharyngitis ( difference 3 % , 95 % confidence interval [ CI ] -2 % to 7 % ) .\
RESULTS	Seventeen patients in the control group ( 43 % ) and 2 patients in the tonsillectomy group ( 4 % ) consulted a physician for pharyngitis ( difference 38 % , 95 % CI 22 % to 55 % ) .\
RESULTS	Overall , 32 patients in the control group ( 80 % ) and 18 patients in the tonsillectomy group ( 39 % ) had an episode of pharyngitis during the 5-month follow-up ( difference 41 % , 95 % CI 22 % to 60 % ) .\
RESULTS	The rate of pharyngitis and number of symptomatic days were significantly lower in the tonsillectomy group than in the control group .\
CONCLUSIONS	There was no significant difference in the number of episodes of severe pharyngitis between the control and treatment groups , and episodes were rare .\
CONCLUSIONS	However , tonsillectomy resulted in fewer symptoms of pharyngitis , consequently decreasing the number of medical visits and days absent from school or work .\
CONCLUSIONS	For this reason , surgery may benefit some patients .\
BACKGROUND	ClinicalTrials.gov , no .\
BACKGROUND	NCT00547391 .\
\
###24976083\
OBJECTIVE	We evaluated patients at tertiary [ both percutaneous coronary intervention ( PCI ) and coronary artery bypass grafting ( CABG ) capable ] and primary hospitals in the EARLY-ACS trial .\
BACKGROUND	Early invasive management is recommended for high-risk non-ST-segment elevation acute coronary syndromes .\
METHODS	We evaluated outcomes in 9,204 patients presenting to : tertiary sites , primary sites with transfer to tertiary sites ( `` transferred '' ) and those who remained at primary sites ( `` non-transfer '' ) .\
RESULTS	There were 348 tertiary ( n = 7,455 patients ) and 89 primary hospitals [ n = 1,749 patients ( 729 transferred ; 1,020 non-transfer ) ] .\
RESULTS	Significant delays occurred in time from symptom onset to angiography ( 49 hr ) , PCI ( 53h ) , and CABG ( 178 hr ) for transferred patients ( P < 0.001 ) .\
RESULTS	Non-transfer patients had less 30-day death/myocardial infarction [ 9.4 % vs. 11.7 % ( tertiary ) ; adjusted odds ratio ( OR ) : 0.78 ( 0.62-0 .97 ) , P = 0.026 ] ; transferred ( 14.0 % ) and tertiary patients were similar [ adjusted OR : 1.23 ( 0.98-1 .53 ) , P = 0.074 ] .\
RESULTS	Non-transfer patients had lower 1-year mortality [ 4.3 % vs. 6.3 % ( tertiary ) ; adjusted hazard ratio ( HR ) : 0.64 ( 0.47-0 .87 ) , P = 0.005 ] : there was no difference between transferred and tertiary patients [ 5.2 % vs. 6.3 % ; adjusted HR : 0.80 ( 0.58-1 .12 ) , P = 0.202 ] .\
RESULTS	Despite similar rates of catheterization , GUSTO severe/moderate bleeding within 120 hr was less in non-transfer [ 3.1 % vs. 6.7 % ( tertiary ) ; adjusted OR : 0.47 ( 0.32-0 .68 ) , P < 0.001 ] , whereas transferred ( 6.1 % ) and tertiary patients were similar [ adjusted OR : 0.94 ( 0.68-1 .30 ) , P = 0.693 ] .\
RESULTS	There was no difference in non-CABG bleeding .\
CONCLUSIONS	Timely angiography and revascularization were often not achieved in transferred patients .\
CONCLUSIONS	Non-transferred patients presenting to primary sites had the lowest event rates and the best long-term survival .\
\
###12958684\
BACKGROUND	This prospective , randomized , and controlled study was designed to investigate the effects of different intraabdominal pressures ( IAPs ) on lipid peroxidation and protein oxidation status during laparoscopic cholecystectomy ( LC ) .\
METHODS	Twenty-four patients ( 12 men , 12 women ) who underwent LC at either 10 or 15 mmHg of IAP were randomized into two groups .\
METHODS	Repeated blood samples were collected to measure thiobarbituric acid reactive substances ( TBARS ) levels to assess lipid peroxidation and protein carbonyl content and protein sulfhydryl groups to assess protein oxidation status .\
RESULTS	Serum protein carbonyls and TBARS levels were found to be increased immediately after desufflation in both study groups when compared to the preoperative levels .\
RESULTS	On the other hand , protein sulfhydryl levels were found to be decreased in both study groups .\
RESULTS	Although increases in protein carbonyls and TBARS levels were more prominent in patients who underwent LC at 15 mmHg of IAP , this difference was not statistically significant between both groups .\
CONCLUSIONS	The results suggest that both 15 and 10 mmHg of LAP could lead to an increased oxidative stress response during LC , but no difference was found between the groups .\
\
###23224207\
BACKGROUND	There is conflicting evidence on the utility of elective intra-aortic balloon pump ( IABP ) use during high-risk percutaneous coronary intervention ( PCI ) .\
BACKGROUND	Observational series have indicated a reduction in major in-hospital adverse events , although randomized trial evidence does not support this .\
BACKGROUND	A recent study has suggested a mortality benefit trend early after PCI , but there are currently no long-term outcome data from randomized trials in this setting .\
RESULTS	Three hundred one patients with left ventricular impairment ( ejection fraction < 30 % ) and severe coronary disease ( BCIS-1 jeopardy score 8 ; maximum possible score = 12 ) were randomized to receive PCI with elective IABP support ( n = 151 ) or without planned IABP support ( n = 150 ) .\
RESULTS	Long-term all-cause mortality was assessed by tracking the databases held at the Office of National Statistics ( in England and Wales ) and the General Register Office ( in Scotland ) .\
RESULTS	The groups were balanced in terms of baseline characteristics ( left ventricular ejection fraction , 23.6 % ; BCIS-1 jeopardy score , 10.4 ) and the amount and type of revascularization performed .\
RESULTS	Mortality data were available for the entire cohort at a median of 51 months ( interquartile range , 41-58 ) from randomization .\
RESULTS	All-cause mortality at follow-up was 33 % in the overall cohort , with significantly fewer deaths occurring in the elective IABP group ( n = 42 ) than in the group that underwent PCI without planned IABP support ( n = 58 ) ( hazard ratio , 0.66 ; 95 % confidence interval , 0.44-0 .98 ; P = 0.039 ) .\
CONCLUSIONS	In patients with severe ischemic cardiomyopathy treated with PCI , all-cause mortality was 33 % at a median of 51 months .\
CONCLUSIONS	Elective IABP use during PCI was associated with a 34 % relative reduction in all-cause mortality compared with unsupported PCI .\
BACKGROUND	URL : http://www.isrctn.org .\
BACKGROUND	Unique identifier : ISRCTN40553718 ; and http://www.clinicaltrials.gov .\
BACKGROUND	Unique identifier : NCT00910481 .\
\
###12188391\
OBJECTIVE	To determine whether the improvement in visual acuity obtained when using high dose dexamethasone in the treatment of traumatic optic neuropathy was comparable to that of megadose methylprednisolone .\
METHODS	A total of forty-four patients with traumatic optic neuropathy were prospectively randomized and selected to receive intravenous high dose dexamethasone or megadose methylprednisolone within 2 weeks of injury .\
METHODS	Age , gender , cause of injury , interval from injury to treatment , initial , post-pulse , and final visual acuity were analysed statistically to compare the dexamethasone and methylprednisolone groups .\
RESULTS	The mean interval to treatment was not significantly different ( p = 0.28 ) for the dexamethasone group at 5.5 days compared to the methylprednisolone group at 4.1 days .\
RESULTS	Visual improvement of at least two lines of the Snellen chart or two levels of unmeasured visual acuity was shown in 9 patients ( 37.5 % ) of the dexamethasone group and 10 patients ( 50 % ) of the methylprednisolone group .\
RESULTS	There was no statistically significant difference between the initial and post-pulse visual acuity ( p = 1.0 ) and the initial and final visual outcome ( p = 0.60 ) in the dexamethasone group compared with the methylprednisolone group .\
CONCLUSIONS	There was no significant difference in the visual acuity obtained after treatment with intravenous dexamethasone or methylprednisolone for traumatic optic neuropathy .\
\
###12586796\
OBJECTIVE	In a series of trials , doxorubicin , bleomycin , vinblastine , and dacarbazine ( ABVD ) and mechlorethamine , vincristine , procarbazine , prednisone , doxorubicin , bleomycin , and vinblastine ( MOPP/ABV ) have been identified as effective treatments for Hodgkin 's disease .\
OBJECTIVE	We compared these regimens as initial chemotherapy for Hodgkin 's disease .\
METHODS	Adult patients ( N = 856 ) with advanced Hodgkin 's disease were randomly assigned to treatment with ABVD or MOPP/ABV .\
METHODS	The major end points were failure-free and overall survival , life-threatening acute toxicities , and serious long-term toxicities , including cardiomyopathy , pulmonary toxicity , myelodysplastic syndromes ( MDS ) , and secondary malignancies .\
RESULTS	The rates of complete remission ( 76 % v 80 % , P = .16 ) , failure-free survival at 5 years ( 63 % v 66 % , P = .42 ) , and overall survival at 5 years ( 82 % v 81 % , P = .82 ) were similar for ABVD and MOPP/ABV , respectively .\
RESULTS	Clinically significant acute pulmonary and hematologic toxicity were more common with MOPP/ABV ( P = .060 and .001 , respectively ) .\
RESULTS	There was no difference in cardiac toxicity .\
RESULTS	There were 24 deaths attributed to initial treatment : nine with ABVD and 15 with MOPP/ABV ( P = .057 ) .\
RESULTS	There have been 18 second malignancies associated with ABVD and 28 associated with MOPP/ABV ( P = .13 ) .\
RESULTS	Thirteen patients have developed MDS or acute leukemia : 11 were initially treated with MOPP/ABV , and two were initially treated with ABVD but subsequently received MOPP-containing regimens and radiotherapy before developing leukemia ( P = .011 ) .\
CONCLUSIONS	ABVD and the MOPP/ABV hybrid are effective therapies for Hodgkin 's disease .\
CONCLUSIONS	MOPP/ABV is associated with a greater incidence of acute toxicity , MDS , and leukemia .\
CONCLUSIONS	ABVD should be considered the standard regimen for treatment of advanced Hodgkin 's disease .\
\
###19397778\
OBJECTIVE	To investigate the modulation of the nociceptive withdrawal reflex ( NWR ) and temporal summation ( TS ) by low-dose acepromazine ( ACP ) in conscious dogs .\
OBJECTIVE	To assess the short - and long-term stability of the reflex thresholds .\
METHODS	Randomized , blinded , placebo-controlled cross-over experimental study .\
METHODS	Eight adult male Beagles .\
METHODS	The NWR was elicited using single transcutaneous electrical stimulation of the ulnar nerve .\
METHODS	Repeated stimuli ( 10 pulses , 5 Hz ) were applied to evoke TS .\
METHODS	The responses of the deltoideus muscle were recorded and quantified by surface electromyography and the behavioural reactions were scored .\
METHODS	Each dog received 0.01 mg kg ( -1 ) ACP or an equal volume saline intravenously ( IV ) at 1 week intervals .\
METHODS	Measurements were performed before ( baseline ) and 20 , 60 and 100 minutes after drug administration .\
METHODS	Sedation was scored before drug administration and then at 10 minutes intervals .\
METHODS	Data were analyzed with Friedman repeated measures analysis of variance on ranks and Wilcoxon signed rank tests .\
RESULTS	Acepromazine resulted in a mild tranquilization becoming obvious at 20 minutes and peaking 30 minutes after injection .\
RESULTS	Single ( I ( t ) ) and repeated stimuli ( TS ( t ) ) threshold intensities , NWR and TS characteristics and behavioural responses were not affected by the ACP at any time point .\
RESULTS	Both I ( t ) and TS ( t ) were stable over time .\
CONCLUSIONS	In dogs , 0.01 mg kg ( -1 ) ACP IV had no modulatory action on the NWR evoked by single or repeated stimuli , suggesting no antinociceptive activity on phasic nociceptive stimuli .\
CONCLUSIONS	The evidence of the stability of the NWR thresholds supports the use of the model as an objective tool to investigate nociception in conscious dogs .\
CONCLUSIONS	A low dose of ACP administered as the sole drug , can be used to facilitate the recordings in anxious subjects without altering the validity of this model .\
\
###23782741\
BACKGROUND	Over 65 % of stroke survivors are either overweight or obese and have multiple cardiovascular risk factors .\
BACKGROUND	However , few studies have examined the effects of comprehensive lifestyle behavior interventions to promote weight loss and control cardiovascular risk factors in stroke survivors .\
BACKGROUND	Thus , the purpose of this study is to examine a novel behavior change approach -- SystemCHANGE -- to promote weight loss and improve health and function in stroke survivors .\
BACKGROUND	SystemCHANGE focuses on redesigning the social environment to achieve a specific goal .\
METHODS	We will conduct a randomized controlled pilot study to examine the efficacy , feasibility , and safety of the SystemCHANGE weight management program in overweight and obese stroke survivors .\
METHODS	The central hypothesis of the study is that the SystemCHANGE intervention will help overweight and obese stroke survivors lose 5 % of their body weight , thereby improving health and function .\
METHODS	Thirty-five stroke survivors will be randomized into either the 6-month SystemCHANGE intervention or a contact-control intervention .\
METHODS	Outcome measures will be assessed at baseline and again at 3 and 6 months after the interventions .\
METHODS	Body composition will be assessed using a Bod Pod .\
METHODS	Patient-reported outcomes will be the Stroke Impact Scale and Reintegration to Normal Living Index .\
METHODS	Objective outcomes will include the 6-Minute Walking Test and Rivermead Motor Assessment .\
CONCLUSIONS	This study will be the first randomized controlled trial to evaluate the efficacy and safety of a weight management intervention in stroke survivors using the SystemCHANGE approach .\
CONCLUSIONS	Furthermore , it will be the first empirically-examined comprehensive lifestyle intervention designed to target physical activity , nutrition , and sleep to promote weight loss in stroke survivors .\
BACKGROUND	ClinicalTrials.gov Identifier : NCT01776034 .\
\
###24608960\
OBJECTIVE	To assess efavirenz plasma concentrations and their association with treatment efficacy and tolerance of efavirenz 600 mg daily in HIV-tuberculosis co-infected patients .\
METHODS	HIV-infected adults with CD4 + T cell count 200/mm ( 3 ) received standard 6-month tuberculosis treatment and antiretroviral therapy including a daily-dose of 600 mg of efavirenz , irrespective of their body weight .\
METHODS	Mid-dose blood samples were drawn both on tuberculosis treatment ( week +2 and week +6 after antiretroviral therapy initiation , and week 22 of follow-up ) and off tuberculosis treatment ( week 50 of follow-up ) .\
METHODS	Considered therapeutic range was 1,000 to 4,000 ng/mL .\
METHODS	Multivariate analysis was performed to evaluate the association between efavirenz concentration below 1,000 ng/mL and virological failure .\
METHODS	Linear regression was used to test the association between efavirenz exposure and CD4 + T cell gain .\
METHODS	Severe side effects potentially related to efavirenz were described and their association with efavirenz exposure was tested by multivariate analysis .\
RESULTS	Efavirenz plasma concentrations were available in 540 patients .\
RESULTS	Median [ interquartile range ] efavirenz concentrations were 2,674 ng/mL [ 1,690-4 ,533 ] , 2,667 ng/mL [ 1,753-4 ,494 ] and 2,799 ng/mL [ 1,804-4 ,744 ] at week +2 , week +6 , week 22 , respectively , and 2,766 ng/mL [ 1,941-3 ,976 ] at week 50 .\
RESULTS	Efavirenz concentrations were lower at week 50 ( off rifampicin ) compared to week 22 ( on rifampicin ) ( p < 0.001 ) .\
RESULTS	Late attendance to study visit and low hemoglobinemia were the only factors associated with an increased risk of efavirenz concentration below 1,000 ng/mL .\
RESULTS	Efavirenz concentration below 1,000 ng/mL was not associated with treatment failure .\
RESULTS	Efavirenz concentration above 4,000 ng/mL was associated with higher risk of central nervous system side effects ( p < 0.001 ) and of hepatotoxicity ( p < 0.001 ) .\
CONCLUSIONS	Body weight and tuberculosis treatment were not associated with low efavirenz concentrations or treatment failure , supporting the 600 mg daily-dose of efavirenz in HIV-tuberculosis co-infected patients .\
CONCLUSIONS	High efavirenz concentrations were related to a higher risk of central nervous system side effects and hepatotoxicity .\
BACKGROUND	ClinicalTrials.gov NCT01300481 .\
\
###22476610\
BACKGROUND	Varenicline is believed to work , in part , by reducing craving responses to smoking cues and by reducing general levels of craving ; however , these hypotheses have never been evaluated with craving assessed in the natural environments of treatment-seeking smokers .\
OBJECTIVE	Ecological momentary assessment procedures were used to assess the impact of varenicline on cue-specific and general craving in treatment-seeking smokers prior to quitting .\
METHODS	For 5 weeks prior to quitting , 60 smokers carried personal digital assistants that assessed their response to smoking or neutral cues .\
METHODS	During week 1 ( baseline ) , participants did not receive medication ; during weeks 2-4 ( drug manipulation ) , participants were randomized to receive varenicline or placebo ; during week 5 ( standard therapy ) , all participants received varenicline .\
METHODS	Craving was assessed before each cue ; cue-specific craving and attention to cue were assessed after each cue .\
RESULTS	During all phases , smoking cues elicited greater craving than neutral cues ; the magnitude of this effect declined after the first week .\
RESULTS	General craving declined across each phase of the study .\
RESULTS	Relative to the placebo condition , varenicline was associated with a greater decline in general craving over the drug manipulation phase .\
RESULTS	Varenicline did not significantly attenuate cue-specific craving during any phase of the study .\
CONCLUSIONS	Smoking cues delivered in the natural environment elicited strong craving responses in treatment-seeking smokers , but cue-specific craving was not affected by varenicline administered prior to the quit attempt .\
CONCLUSIONS	These findings suggest that the clinical efficacy of varenicline is not mediated by changes in cue-specific craving during the pre-quit period of treatment-seeking smokers .\
\
###24471739\
OBJECTIVE	The relative efficiency of different eye exercise regimes is unclear , and in particular the influences of practice , placebo and the amount of effort required are rarely considered .\
OBJECTIVE	This study measured conventional clinical measures following different regimes in typical young adults .\
METHODS	A total of 156 asymptomatic young adults were directed to carry out eye exercises three times daily for 2 weeks .\
METHODS	Exercises were directed at improving blur responses ( accommodation ) , disparity responses ( convergence ) , both in a naturalistic relationship , convergence in excess of accommodation , accommodation in excess of convergence , and a placebo regime .\
METHODS	They were compared to two control groups , neither of which were given exercises , but the second of which were asked to make maximum effort during the second testing .\
RESULTS	Instruction set and participant effort were more effective than many exercises .\
RESULTS	Convergence exercises independent of accommodation were the most effective treatment , followed by accommodation exercises , and both regimes resulted in changes in both vergence and accommodation test responses .\
RESULTS	Exercises targeting convergence and accommodation working together were less effective than those where they were separated .\
RESULTS	Accommodation measures were prone to large instruction/effort effects and monocular accommodation facility was subject to large practice effects .\
CONCLUSIONS	Separating convergence and accommodation exercises seemed more effective than exercising both systems concurrently and suggests that stimulation of accommodation and convergence may act in an additive fashion to aid responses .\
CONCLUSIONS	Instruction/effort effects are large and should be carefully controlled if claims for the efficacy of any exercise regime are to be made .\
\
###23564919\
OBJECTIVE	To evaluate the efficacy and safety of canagliflozin , a sodium glucose cotransporter 2 inhibitor , compared with sitagliptin in subjects with type 2 diabetes inadequately controlled with metformin plus sulfonylurea .\
METHODS	In this 52-week , randomized , double-blind , active-controlled , phase 3 study , subjects using stable metformin plus sulfonylurea ( N = 755 ) received canagliflozin 300 mg or sitagliptin 100 mg daily .\
METHODS	Primary end point was change from baseline in A1C at 52 weeks .\
METHODS	Secondary end points included change in fasting plasma glucose ( FPG ) and systolic blood pressure ( BP ) , and percent change in body weight , triglycerides , and HDL cholesterol .\
METHODS	Safety was assessed based on adverse event ( AE ) reports .\
RESULTS	At 52 weeks , canagliflozin 300 mg demonstrated noninferiority and , in a subsequent assessment , showed superiority to sitagliptin 100 mg in reducing A1C ( -1.03 % [ -11.3 mmol/mol ] and -0.66 % [ -7.2 mmol/mol ] , respectively ; least squares mean difference between groups , -0.37 % [ 95 % CI , -0.50 to -0.25 ] or -4.0 mmol/mol [ -5.5 to -2.7 ] ) .\
RESULTS	Greater reductions in FPG , body weight , and systolic BP were observed with canagliflozin versus sitagliptin ( P < 0.001 ) .\
RESULTS	Overall AE rates were similar with canagliflozin ( 76.7 % ) and sitagliptin ( 77.5 % ) ; incidence of serious AEs and AE-related discontinuations was low for both groups .\
RESULTS	Higher incidences of genital mycotic infections and osmotic diuresis-related AEs were observed with canagliflozin , which led to one discontinuation .\
RESULTS	Hypoglycemia rates were similar in both groups .\
CONCLUSIONS	Findings suggest that canagliflozin may be a new therapeutic tool providing better improvement in glycemic control and body weight reduction than sitagliptin , but with increased genital infections in subjects with type 2 diabetes using metformin plus sulfonylurea .\
\
###22011268\
OBJECTIVE	To examine the reliability of the web-based GMFCS Family Report Questionnaire ( GMFCS-FR ) between 8 and 11 years old children , compared with the GMFCS-Expanded and Revised ( GMFCS-E & R ) .\
METHODS	The GMFCS-FR was translated from the English GMFCS-FR into Danish after the CanChild guidelines ; only the order of levels was chosen like in the GMFCS-E & R. Families of 30 children with spastic and dystonic cerebral palsy ( age from 8 to 11 years , randomly selected from a cerebral palsy register ) answered the GMFCS-FR and were later interviewed by two physiotherapists .\
METHODS	Participants and non-responders were compared on basic parameters available from the Danish CP register .\
METHODS	Inter-rater agreement and weighted was calculated in order to compare the translated GMFCS-FR with physiotherapist 's applied GMFCS-E & R.\
RESULTS	The inter-rater agreement between the GMFCS-FR in Danish and the GMFCS-E & R was high ( 76 % ) and misclassification was minimal .\
RESULTS	There was a good agreement on the same or nearby levels ( weighted = 0.76 and 0.81 ) .\
RESULTS	The family rated the same or less ability , when compared with trained physiotherapists .\
CONCLUSIONS	The GMFCS-FR is a reliable tool for GMFCS evaluation among 8-11 years old Danish children with CP .\
CONCLUSIONS	The tendency for less-ability rating by families is important when performing and comparing results from epidemiological studies based on GMFCS-FR and GMFCS-E & R.\
\
###25260436\
BACKGROUND	Left atrial ( LA ) strain is a sensitive measure of LA mechanics .\
BACKGROUND	However , its relationship with rhythm outcomes after catheter ablation in patients with atrial fibrillation ( AF ) is not well established .\
BACKGROUND	The aim of this study was to evaluate whether baseline LA global longitudinal strain ( LA ) predicts rhythm outcomes in patients who undergo catheter ablation for AF .\
METHODS	In 256 patients with AF ( paroxysmal , 204 ; persistent , 52 ) , comprehensive echocardiography was performed with assessment of LA by using Velocity Vector Imaging to calculate average strain values from apical four - and two-chamber views before ablation ( median , 41 days ; interquartile range , 1-95 days ) .\
RESULTS	After a median of 8.0 months ( interquartile range , 4.0-23 .3 months ) of follow-up , 149 patients ( 58 % ) had maintained sinus rhythm and 107 patients ( 42 % ) had recurrence of AF .\
RESULTS	In our study cohort ( mean age 5911years ; mean left ventricular ejection fraction , 5810 % ) , impaired total LA ( LAtotal ) was associated with greater left ventricular mass index ( r = -0.245 , P < .001 ) and worsening left ventricular diastolic function ( ratio of transmitral flow peak early diastolic velocity to peak early diastolic velocity of the mitral annulus : r = -0.357 , P < .001 ; maximal LA volume index : r = -0.393 , P < .001 ) .\
RESULTS	Patients with LAtotal < 23.2 % showed a higher incidence of AF recurrence compared with patients with LAtotal 23.2 % ( log-rank P < .001 ) .\
RESULTS	In multivariate Cox proportional-hazards analysis , LAtotal was independently related to rhythm outcomes ( hazard ratio , 0.944 ; 95 % confidence interval , 0.915-0 .975 ; P < .001 ) after AF ablation .\
RESULTS	Moreover , LAtotal provided incremental predictive value for rhythm outcomes over clinical features ( increment in global ( 2 ) = 14.63 , P < .001 ) .\
CONCLUSIONS	In patients with AF , baseline LAtotal was associated with rhythm outcome after catheter ablation .\
\
###19111215\
OBJECTIVE	The purpose of this study was to evaluate the effect of irrigation fluid temperature on body temperature and other variables , and to determine their correlations .\
METHODS	A prospective randomized study was performed of 50 patients undergoing arthroscopic shoulder surgery who received irrigation fluid either with room temperature or warmed to 37 degrees C to 39 degrees C. Core body temperature was checked at regular intervals , and additional variables , such as length of anesthesia and surgery , amount of irrigation fluid and intravenous fluid used , amount of bleeding , weight gain , and postoperative pain were collected during surgery and postoperatively .\
RESULTS	The final core body temperature was 35.5 + / - 0.3 degrees C in the room-temperature fluid group and 36.2 + / - 0.3 degrees C in the warmed fluid group ( P < .001 ) .\
RESULTS	The temperature drop was 0.86 + / - 0.2 degrees C in the room-temperature fluid group and 0.28 + / - 0.2 degrees C in the warmed fluid group ( P < .001 ) .\
RESULTS	Hypothermia occurred in 91.3 % of patients in the room-temperature fluid group ; the incidence of hypothermia was much lower in the warmed fluid group ( 17.4 % ; P < .001 ) .\
RESULTS	Of the variables measured , the patient 's age and amount of irrigation fluid used correlated with core body temperature in the room-temperature fluid group .\
RESULTS	No variables correlated with core body temperature in the warmed fluid group .\
CONCLUSIONS	Hypothermia occurred more often in shoulder arthroscopic surgery with room-temperature fluid irrigation than with warmed fluid irrigation .\
CONCLUSIONS	The patient 's age and amount of irrigation fluid used correlate with core body temperature when using room-temperature irrigation fluid .\
CONCLUSIONS	The use of warm irrigation fluid during arthroscopic shoulder surgery decreases perioperative hypothermia , especially in elderly patients .\
METHODS	Level I , therapeutic randomized controlled trial .\
\
###12486418\
BACKGROUND	The overall effect sizes estimated from randomized clinical trials may not apply similarly to all patients .\
BACKGROUND	Univariate subgroup analyses are often used to help determine the generalizability of a trial 's results , but may themselves be misleading .\
BACKGROUND	We reanalyzed the Studies of Left Ventricular Dysfunction ( SOLVD ) to determine whether the treatment effect depended on the patients ' baseline prognosis , defined on the basis of multiple clinical variables .\
METHODS	The SOLVD prevention ( 4228 patients ) and the SOLVD treatment ( 2569 patients ) trials were randomized , double-blind trials that studied the effect of enalapril in patients with reduced left-ventricular function or congestive heart failure .\
METHODS	We combined both SOLVD populations and compared the results of a univariate analysis to a multivariate approach in which 3 patient subgroups were defined according to baseline risks for the combined end point of death or hospitalization for heart failure .\
RESULTS	Enalapril treatment resulted in 24 % fewer events .\
RESULTS	The strongest predictors of an event were ejection fraction , New York Heart Association classification and age , antiplatelet agents , history of diabetes mellitus , treatment with digoxin or diuretics , and race .\
RESULTS	Only ejection fraction produced a significant treatment interaction ( P = .004 ) .\
RESULTS	Consistent with the original SOLVD reports , this interaction was also demonstrable when ejection fraction was scaled into tertiles and examined on its own ( P = .012 ) .\
RESULTS	However , there was no interaction present when patients were divided into tertiles of multifactorial baseline risk .\
CONCLUSIONS	We confirmed the treatment effect of enalapril , the impact of left-ventricular systolic function , and the negative prognostic importance of diabetes mellitus in this population .\
CONCLUSIONS	Although ejection fraction led to a subgroup-treatment interaction in the main SOLVD publications , a multifactorial approach to prognostic grouping abolished the interaction .\
CONCLUSIONS	These findings highlight the limitations of univariate subgroup analyses and illustrate that multivariate risk group analysis may be a complementary method for assessing the generalizability of the overall treatment effects observed in randomized trials .\
\
###12051570\
OBJECTIVE	The objective of the present study in 60 patients with chronic tinnitus aurium was to confirm the efficacy of oral treatment with 2 x 80 mg Ginkgo special extract EGb 761 per day subsequent to 10-day EGb 761 infusion treatment .\
METHODS	Patients with chronic tinnitus aurium underwent 10 days of in-patient infusion treatment with 200 mg/day EGb 761 , after which they were randomized to double-blind , oral out-patient treatment with either 2 x 80 mg/day EGb 761 or placebo , given over a scheduled treatment period of 12 weeks .\
METHODS	The primary outcome measure was the change in tinnitus volume in the more severely affected ear during randomized treatment .\
RESULTS	Fifty-two of 60 patients ( 89.7 % ) completed the infusion treatment ; complete sets of data were available for 40 ( 66.7 % ) , 30 ( 50.0 % ) and 22 ( 36.7 % ) patients after 4 , 8 and 12 weeks of randomized treatment , respectively .\
RESULTS	For the primary outcome measure , significant superiority of EGb 761 over placebo was demonstrated in the intention-to-treat analysis data set after 4 , 8 and 12 weeks of out-patient treatment ( p < 0.05 , 1-tailed ) , although the absolute treatment group difference was moderate .\
RESULTS	The results were supported by the secondary outcome measures for efficacy ( e.g. decreased hearing loss , improved self-assessment of subjective impairment ) .\
RESULTS	During out-patient treatment , there were no attributable adverse events under EGb 761 .\
CONCLUSIONS	A combination of infusion therapy followed by oral administration of Ginkgo special extract EGb 761 appears to be effective and safe in alleviating the symptoms associated with tinnitus aurium .\
\
###20067513\
BACKGROUND	Ezetimibe , a cholesterol-absorption inhibitor , significantly lowers low-density lipoprotein cholesterol ( LDL-C ) when administered in addition to statin treatment .\
BACKGROUND	The effect of ezetimibe on the incidence and progression of vascular disease is elusive .\
BACKGROUND	The objective of the study was to examine the effects of fluvastatin plus ezetimibe on lipoprotein subfractions in patients with type 2 diabetes and/or coronary heart disease .\
METHODS	Ninety patients with LDL-C between 100 and 160 mg dL ( -1 ) were enrolled in this prospective , randomized , single-blind , single-centre study .\
METHODS	A total of 84 patients were treated with either fluvastatin 80 mg ( n = 28 ) alone or in combination with ezetimibe 10 mg ( n = 56 ) for 12 weeks to determine the effects on lipids , apolipoproteins and LDL subfractions by equilibrium density gradient ultracentrifugation .\
METHODS	This study is registered with ClinicalTrials.gov , number NCT00814723 .\
RESULTS	Total cholesterol , LDL-C and apolipoprotein B were significantly more reduced in the combined therapy group .\
RESULTS	High density lipoproteins increased in the fluvastatin-only group and decreased in the combined therapy group .\
RESULTS	There was a significant difference between the two groups in buoyant and intermediate , but not in dense LDL particles .\
CONCLUSIONS	Addition of ezetimibe to fluvastatin resulted in a further reduction of buoyant and intermediate , but not of dense LDL compared with fluvastatin alone .\
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###17666359\
OBJECTIVE	To compare the long-term effect and safety of tacrolimus ( FK506 ) and cyclosporine ( CsA ) in kidney transplant ( KT ) recipients carrying hepatitis B Virus ( HBV ) .\
METHODS	A total of 109 patients with HBV were randomized into FK506 group ( 52 cases ) and CsA group ( 57 cases ) after KT , and a 2-year-long follow-up of the patients was conducted to record the patient and graft survival , incidence of acute graft rejection and postoperative liver function .\
RESULTS	The 2-year patient/graft survival was 86.0 % / 73.7 % and 94.2 % / 90.3 % in CsA and FK506 groups , respectively ( P < 0.05 ) , with incidence of acute rejection of 10.5 % and 9.6 % ( P > 0.05 ) , and rate of abnormal liver function of 26.3 % and 15.4 % ( P < 0.05 ) , respectively .\
RESULTS	Eight patients ( 14.4 % ) in CsA group required a drug conversion but none in FK506 group .\
RESULTS	The drug conversion resulted in significant reduction of ALT/AST level from 255.13 + / -31.38 / 201.88 + / -21.25 U/L to 31.25 + / -11.50 / 25.13 + / -9.68 U/L ( P < 0.01 ) .\
CONCLUSIONS	For HBV-carrying renal transplant recipients , FK506 as the primary choice of immunosuppressant can be more effective and safer than CsA .\
\
###19450071\
OBJECTIVE	This study was performed retrospectively to determine if Medicare claims data could be used to evaluate the cost effectiveness , from a payer perspective , of different radiation treatment schedules evaluated in a national clinical trial .\
METHODS	Medicare costs from all providers and all places of service were obtained from the Centers for Medicare & Medicaid Services for patients treated in the period 1992-1996 on Radiation Therapy Oncology Group 90-03 , and combined with data on outcomes from the trial .\
RESULTS	Of the 1,113 patients entered , Medicare cost data and clinical outcomes were available for 187 patients .\
RESULTS	Significant differences in tolerance of treatment and outcome were noted between patients with Medicare data included in the study and patients without Medicare data , and non-Medicare patients excluded from it .\
RESULTS	Ninety-five percent confidence ellipses on the incremental cost-effectiveness scatterplots crossed both axes , indicating non-significant differences in cost effectiveness between radiation treatment schedules .\
CONCLUSIONS	Claims data permit estimation of cost effectiveness , but Medicare data provide inadequate representation of results applicable to patients from the general population .\
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###10743796\
OBJECTIVE	To evaluate the safety , immunogenicity , pharmacokinetics , and efficacy of intravenous administration of tumor necrosis factor binding protein ( TNFbp ) dimer in patients with rheumatoid arthritis ( RA ) .\
METHODS	This phase I/II study was a multicenter , randomized , double blind , placebo controlled , ascending dose study evaluating TNFbp dimer administered by i.v. infusion .\
METHODS	Thirty-three patients with RA divided into 3 cohorts received TNFbp dimer ( 30 , 100 , 300 microg/kg ) or placebo during a 5 min infusion at baseline and at 3 and 6 weeks ; patients were followed at routine intervals after each infusion through 77 days postinfusion .\
METHODS	Pharmacokinetics were analyzed using a log-linear regimen and comparisons were made between half-life after first , 2nd , and 3rd doses .\
METHODS	Plasma TNFbp dimer concentrations and serum antibody levels were used in the measurement of pharmacokinetics .\
RESULTS	Administration of 30 microg/kg of TNFbp dimer was generally well tolerated ; the maximum tolerated dose was 100 microg/kg .\
RESULTS	No serious adverse events were reported .\
RESULTS	A significant antibody response affected the half-life and clearance of TNFbp dimer at each dose group .\
RESULTS	Anti-TNFbp antibodies were noncytotoxic and nonagonistic .\
RESULTS	Clinical evaluations provided evidence of in vivo activity of TNFbp dimer in these patients .\
CONCLUSIONS	TNFbp dimer administered to patients with long standing RA resulted in significant antibody production to the study drug .\
CONCLUSIONS	This effect reduced the half-life and clearance of the TNFbp .\
CONCLUSIONS	This TNFbp will not be a viable option for treating patients with RA secondary to immunogenicity .\
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###20431290\
BACKGROUND	Subclinical brain infarct ( SBI ) is associated with subsequent stroke and cognitive decline .\
BACKGROUND	A longitudinal epidemiological study suggests that statins may prevent development of SBI .\
BACKGROUND	We investigated the effects of statins upon development of brain infarct by performing a post-hoc analysis of the Regression of Cerebral Artery Stenosis ( ROCAS ) study .\
METHODS	The ROCAS study is a randomized , double-blind , placebo-controlled study evaluating the effects of simvastatin 20 mg daily upon progression of asymptomatic middle cerebral artery stenosis among stroke-free individuals over 2 years .\
METHODS	A total of 227 subjects were randomized to either placebo ( n = 114 ) or simvastatin 20 mg daily ( n = 113 ) .\
METHODS	The number of brain infarcts as detected by MRI was recorded at baseline and at the end of the study .\
METHODS	The primary outcome measure was the number of new brain infarcts at the end of the study .\
RESULTS	Among the 227 randomized subjects , 33 ( 14.5 % ) had SBI at baseline .\
RESULTS	At the end of the study , significantly fewer subjects in the active group ( n = 1 ) had new brain infarcts compared with the placebo group ( n = 8 ; p = 0.018 ) .\
RESULTS	The new brain infarcts of subjects in the active group were subclinical .\
RESULTS	Among the placebo group , the new brain infarcts of 3 subjects were symptomatic while those of the remaining 5 subjects were subclinical .\
RESULTS	Among putative variables , multivariate regression analysis showed that only the baseline number of SBIs ( OR = 6.27 , 95 % CI 2.4-16 .5 ) and simvastatin treatment ( OR = 0.09 , 95 % CI 0.01-0 .82 ) independently predicted the development of new brain infarcts .\
CONCLUSIONS	Consistent with findings of the epidemiological study , our study suggests that statins may prevent the development of a new brain infarct .\
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###22524072\
OBJECTIVE	The present study evaluated the effect of listening to a pictorial story about going to the dentist on pain perception , situational anxiety and behavioral feedback during dental treatment in pediatric dental patients .\
METHODS	Eighty , 6-7-year-old children were included The childhood anxiety-related disorders using Screen for Child Anxiety Related Disorders ( SCARED ) Parent Version scale and intelligence quotient using Raven 's Progressive Matrices were evaluated The subjects were randomly assigned to two groups , listening to a pictorial story about going to a dentist ( test ) , or listening to a pictorial story about going to a barbershop ( control ) .\
METHODS	A dental treatment was performed on each subject , during which , behavior was assessed using Sound , Eye , and Motor Scale .\
METHODS	Pain perception and situational anxiety were then assessed using Wong-Baker Fasces Pain Rating Scale and Faces version of the Modified Child Dental Anxiety Scale , respectively .\
RESULTS	There was a significant decrease in pain perception ( P = 0.02 ) and situational anxiety ( P < 0.001 ) in the test group .\
RESULTS	In addition , the test intervention significantly improved children behavioral feedback during dental treatment ( P < 0.001 ) .\
CONCLUSIONS	Preparation of children with pictorial story can be effective in decreasing pain perception and situational anxiety as well as improving behavior during dental treatment .\
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###17499284\
OBJECTIVE	High grade prostatic intraepithelial neoplasia is likely a premalignant lesion of the prostate .\
OBJECTIVE	Decreasing the frequency of high grade PIN may decrease the risk of prostate cancer .\
OBJECTIVE	In the Prostate Cancer Prevention Trial we evaluated the impact of finasteride on the risk of a needle biopsy diagnosis of high grade prostatic intraepithelial neoplasia .\
METHODS	The Prostate Cancer Prevention Trial was a randomized , placebo controlled clinical trial that enrolled 18,882 men without evidence of prostate cancer , prostate specific antigen less than 3.0 ng/ml and normal digital rectal examination , and randomized them to 5 mg finasteride daily or placebo .\
METHODS	Subjects were followed for 7 years with biopsy recommended for prostate specific antigen greater than 4.0 ng/ml , adjusted in the finasteride group to achieve an equal number of biopsy recommendations or for abnormal digital rectal examination .\
METHODS	All cancer-free subjects were recommended to undergo biopsy after 7 years on study .\
METHODS	We evaluated the diagnosis of high grade prostatic intraepithelial neoplasia with or without concomitant prostate cancer in these 2 study groups .\
RESULTS	The number of men evaluable for high grade prostatic intraepithelial neoplasia was 4,568 in the finasteride group and 4,886 in the placebo group .\
RESULTS	High grade prostatic intraepithelial neoplasia alone was diagnosed in 276 men ( 6.0 % ) in the finasteride group vs 347 ( 7.1 % ) in the placebo group ( RR 0.85 , 95 % CI 0.73-0 .99 , p = 0.04 ) .\
RESULTS	High grade prostatic intraepithelial neoplasia accompanied by prostate cancer was diagnosed in 144 men ( 3.2 % ) in the finasteride group vs 223 ( 4.6 % ) in the placebo group ( RR 0.69 , 95 % CI 0.56-0 .85 , p = 0.0004 ) .\
RESULTS	Finasteride significantly decreased the overall risk of high grade prostatic intraepithelial neoplasia ( alone and with cancer ) from 570 cases ( 11.7 % ) in the placebo group to 420 ( 9.2 % ) in the finasteride group ( HR 0.79 , 95 % CI 0.70-0 .89 , p < 0.001 ) .\
CONCLUSIONS	Finasteride significantly decreased the risk of high grade PIN .\
CONCLUSIONS	This observation may explain how finasteride decreased prostate cancer in the Prostate Cancer Prevention Trial , supporting the notion that high grade prostatic intraepithelial neoplasia is a premalignant lesion of the prostate , and it provides new information relevant to the consideration of finasteride for prostate cancer prevention .\
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###15860852\
OBJECTIVE	A national multicenter randomized study compared the efficacy of 2 x 8 Gy versus our standard 10 x 3 Gy in patients with inoperable stage IIIA/B ( with an Eastern Cooperative Oncology Group score of 3 to 4 and/or substantial weight loss ) and stage IV non-small-cell lung cancer .\
METHODS	Between January 1999 and June 2002 , 297 patients were eligible and randomized to receive either 10 x 3 Gy or 2 x 8 Gy by external-beam irradiation .\
METHODS	The primary end point was a patient-assessed score of treatment effect on seven thoracic symptoms using an adapted Rotterdam Symptom Checklist .\
METHODS	Study sample size was determined based on an average total symptom score difference of more than one point over the initial 39 weeks post-treatment .\
METHODS	The time course of symptom scores were also evaluated , and other secondary end points were toxicity and survival .\
RESULTS	Both treatment arms were equally effective , as the average total symptom score over the initial 39 weeks did not differ .\
RESULTS	However , the pattern in time of these scores differed significantly ( P < .001 ) .\
RESULTS	Palliation in the 10 x 3-Gy arm was more prolonged ( until week 22 ) with less worsening symptoms than in 2 x 8-Gy .\
RESULTS	Survival in the 10 x 3-Gy arm was significantly ( P = .03 ) better than in the 2 x 8-Gy arm with 1-year survival of 19.6 % ( 95 % CI , 14.1 % to 27.3 % ) v 10.9 % ( 95 % CI , 6.9 % to 17.3 % ) .\
CONCLUSIONS	The 10 x 3-Gy radiotherapy schedule is preferred over the 2 x 8-Gy schedule for palliative treatment , as it improves survival and results in a longer duration of the palliative response .\
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###24517167\
BACKGROUND	The model of Family group-conferencing ( FG-c ) for decision making in child welfare has rapidly spread over the world during the past decades .\
BACKGROUND	Its popularity is likely to be caused by its philosophy , emphasizing participation and autonomy of families , rather than based on positive research outcomes .\
BACKGROUND	Conclusive evidence regarding the ( cost ) effectiveness of FG-c is not yet available .\
BACKGROUND	The aim of this protocol is to describe the design of a study to evaluate the ( cost ) effectiveness of FG-c as compared to Treatment as Usual .\
METHODS	The effectiveness of FG-c will be examined by means of a Randomized Controlled Trial .\
METHODS	A multi-informant approach will be used to assess child safety as the primary outcome , and commitment of the social network , perceived control / empowerment ; family functioning and use of professional care as secondary outcomes .\
METHODS	Implementation of FG-c , characteristics of family manager and family will be examined as moderators of effectiveness .\
CONCLUSIONS	Studying the effectiveness of Fg-c is crucial now the method is being implemented all over the world as a decision making model in child and youth care .\
CONCLUSIONS	Policy makers should be informed whether the ideals of participation in society and the right for self-determination indeed result in more effective care plans , and the money spent on FG-c is warranted .\
BACKGROUND	Dutch Trial Register number NTR4320 .\
BACKGROUND	The design of this study is approved by the independent Ethical Committee of the Faculty of Social and Behavioral Sciences of The University of Amsterdam ( approval number : 2013-POWL-3308 ) .\
BACKGROUND	This study is financially supported by a grant from ZonMw , The Netherlands Organization for Health Research and Development , grant number : 70-72900-98-13158 .\
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###25444803\
OBJECTIVE	This study was designed to identify the optimal dose of an MF59-adjuvanted , monovalent , A/H1N1 influenza vaccine in healthy paediatric subjects .\
METHODS	Subjects aged 3-8 years ( n = 194 ) and 9-17 years ( n = 160 ) were randomized to receive two primary doses of A/H1N1 vaccine containing either 3.75 g antigen with half a standard dose of MF59 adjuvant , 7.5 g antigen with a full dose of MF59 , or ( children 3-8 years only ) , a non-adjuvanted 15 g formulation .\
METHODS	A booster dose of MF59-adjuvanted seasonal influenza vaccine including homologous A/H1N1 strain was given one year after priming .\
METHODS	Immunogenicity was assessed by haemagglutination inhibition ( HI ) and microneutralization assays .\
METHODS	Vaccine safety was assessed throughout the study ( up to 18 months ) .\
RESULTS	A single priming dose of either MF59-adjuvanted formulation was sufficient to meet the European licensure criteria for pandemic influenza vaccines ( HI titres 1:40 > 70 % ; seroconversion > 40 % ; and GMR > 2.5 ) .\
RESULTS	Two non-adjuvanted vaccine doses were required to meet the same licensure criteria .\
RESULTS	After first and second doses , percentage of subjects with HI titres 1:40 were between 97 % and 100 % in the adjuvanted vaccine groups compared with 68 % and 91 % in the non-adjuvanted group , respectively .\
RESULTS	Postvaccination seroconversion rates ranged from 91 % to 98 % in adjuvanted groups and were 68 % ( first dose ) and 98 % ( second dose ) in the non-adjuvanted group .\
RESULTS	HI titres 1:330 after primary doses were achieved in 69 % to 90 % in adjuvanted groups compared with 41 % in the non-adjuvanted group .\
RESULTS	Long-term antibody persistence after priming and a robust antibody response to booster immunization were observed in all vaccination groups .\
RESULTS	All A/H1N1 vaccine formulations were generally well tolerated .\
RESULTS	No vaccine-related serious adverse events occurred , and no subjects were withdrawn from the study due to an adverse event .\
CONCLUSIONS	An MF59-adjuvanted influenza vaccine containing 3.75 g of A/H1N1 antigen was well tolerated and sufficiently immunogenic to meet all the European licensure criteria after a single dose in healthy children 3-17 years old .\
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###8860389\
OBJECTIVE	Chronic middle ear disease is common in Aboriginal children , and may be linked to nasal inflammation and Eustachian tube dysfunction .\
OBJECTIVE	The pattern of nasal inflammation is unknown .\
OBJECTIVE	The study reported here was performed to define the role of allergy and infection in causing nasal inflammation in Aboriginal children with chronic middle ear disease .\
METHODS	Thirty-one Aboriginal children aged between 3 and 7 years underwent clinical assessment , audiometry and allergy skin tests .\
METHODS	Nasal swabs for bacterial culture and cytology were performed during the winter and again in spring to identify any seasonal variation .\
METHODS	A randomized trial of nasal beclomethasone for 8 weeks was conducted in children with abnormal tympanometry to identify the effect of therapy upon nasal cytology .\
RESULTS	Twenty-six of the 31 children had abnormal tympanograms .\
RESULTS	Average hearing levels were reduced in nine children .\
RESULTS	Pathogenic organisms were isolated from most children : Streptococcus pneumoniae ( 82 % ) , Haemophilus influenzae ( 79 % ) , Moraxella catarrhalis ( 39 % ) and Staphylococcus aureus ( 29 % ) .\
RESULTS	Eight of the 31 children ( 26 % ) were atopic .\
RESULTS	Nasal cytology disclosed a marked neutrophil infiltrate ( 80 % of cells ) during the winter , which fell significantly in spring to 52 % of cells .\
RESULTS	Only two subjects had nasal eosinophilia of > 10 % .\
RESULTS	There was no effect of beclomethasone on nasal cytology .\
CONCLUSIONS	Chronic ear disease in Aboriginal children is associated with nasal inflammation , neutrophil infiltration and the presence of bacteria .\
CONCLUSIONS	These features suggest respiratory infection as the main cause of chronic nasal inflammation in Aboriginal children with middle ear disease .\
CONCLUSIONS	There is a seasonal variation in the severity of the nasal infiltrate , consistent with increased infections during winter .\
CONCLUSIONS	Despite a high prevalence of atopy , allergic nasal disease was uncommon .\
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###10397212\
OBJECTIVE	To investigate whether prolonged infusion of N-acetylcysteine ( NAC ) that is commenced immediately after admission to the intensive care unit could ameliorate the development or progression of multisystem organ failure and improve mortality .\
METHODS	Prospective , randomized , double-blinded clinical trial .\
METHODS	Six-bed intensive care unit in a teaching hospital .\
METHODS	Of the 100 patients recruited ( 14 withdrew ) , 86 patients were studied .\
METHODS	After randomization , the treatment group ( n = 41 ) received NAC ( 150 mg/kg bolus followed by a continuous infusion of 12 mg/kg/hr ) and the placebo group ( n = 45 ) received 5 % dextrose , from a minimum of 3 days up to a maximum of 5 days .\
RESULTS	There was no statistically significant difference between the two groups regarding outcome as indicated by mortality and the required days of inotropic support , mechanical ventilation , and intensive care .\
RESULTS	The time interval between hospital and intensive care unit admission showed great variability , with a median of 24 hrs for the whole sample .\
RESULTS	By splitting the groups with this median value , the effect of NAC was examined on patients admitted within 24 hrs and after 24 hrs of arrival to the hospital .\
RESULTS	There was a nonsignificant difference in mortality in favor of NAC .\
RESULTS	Patients admitted after 24 hrs of hospital admission had a significantly worse mortality in the NAC-treated group ( 61 % vs. 32 % for controls ; p = .05 ) .\
CONCLUSIONS	We found a nonsignificant difference in outcome between NAC and placebo-treated patients .\
CONCLUSIONS	Our results suggest that the initiation of NAC treatment > 24 hrs after hospital admission may potentially be harmful , and further studies should be undertaken to investigate the clinical use of the early application of NAC in critically ill patients .\
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###21852698\
OBJECTIVE	Offering antenatal sickle cell and thalassaemia ( SCT ) screening early in pregnancy can maximize the range of post-screening choices available , however these benefits should not be obtained at the expense of informed choice .\
OBJECTIVE	This study examined whether offering this screening in primary care at the time of pregnancy confirmation compromises women making informed choices .\
OBJECTIVE	Design Partial factorial , cluster randomized controlled trial .\
METHODS	25 general practices in two socially deprived UK areas .\
METHODS	Participants 464 pregnant women offered antenatal SCT screening .\
METHODS	Intervention Practices were randomly allocated to offer pregnant women screening : i ) in primary care at time of pregnancy confirmation , with parallel partner testing ( n = 191 ) , ii ) in primary care at time of pregnancy confirmation , with sequential partner testing ( n = 158 ) , or iii ) in secondary care by midwives , with sequential partner testing ( standard care , n = 115 ) .\
METHODS	Main outcome Informed choice - a classification based on attitudes , knowledge and test uptake .\
RESULTS	91 % of woman underwent screening .\
RESULTS	About a third ( 30.6 % ) made an informed choice to accept or decline screening : 34 % in primary care parallel group ; 23.4 % in primary care sequential and 34.8 % in secondary care sequential .\
RESULTS	Allowing for adjustments , rates of informed choice did not vary by intervention group : secondary care versus primary care with parallel partner testing OR 1.07 ( 95 % CI 0.56 to 2.02 ) ; secondary care versus primary care with sequential partner testing OR 0.67 ( 95 % CI 0.36 to 1.25 ) .\
RESULTS	Uninformed choices were generally attributable to poor knowledge ( 65 % ) .\
CONCLUSIONS	Offering antenatal SCT screening in primary care did not reduce the likelihood that women made informed choices .\
CONCLUSIONS	Rates of informed choice were low and could be increased by improving knowledge .\
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###22751032\
OBJECTIVE	Pain management is limited by inability to match a patient 's condition-and pain mechanisms-to optimal treatment ( s ) .\
OBJECTIVE	Much is known about pain treatment from animal investigations , but antinociceptive mechanisms can not be readily explored in clinical studies .\
OBJECTIVE	Evidence suggests that self-report verbal pain descriptors characterize important pain dimensions and may reflect diverse underlying mechanisms .\
METHODS	This exploratory analysis of data from a trial of a gabapentin-morphine combination evaluated effects of treatment on short-form McGill Pain Questionnaire sensory and affective descriptor profiles and prediction of treatment response by these descriptors .\
RESULTS	Severity of `` throbbing , '' `` shooting , '' and `` aching '' improved preferentially with morphine over gabapentin , whereas `` tiring-exhausting '' and `` sickening '' improved preferentially with gabapentin over morphine .\
RESULTS	Improvement in descriptor severity with gabapentin-morphine combination was superior to active placebo for 12 of 15 short-form McGill Pain Questionnaire descriptors , whereas morphine and gabapentin were superior to active placebo for only 7 and 6 descriptors , respectively .\
RESULTS	Baseline moderate-severe `` throbbing '' and `` hot-burning '' predicted poor outcomes with gabapentin , whereas moderate-severe `` aching '' and `` punishing-cruel '' predicted favorable outcomes with gabapentin .\
RESULTS	Baseline `` throbbing '' severity also predicted poor outcomes with morphine .\
RESULTS	Baseline allodynia predicted superior reduction of `` stabbing '' with morphine but not with gabapentin alone .\
CONCLUSIONS	These results point to the hypothesis that sensory and affective pain descriptor profiles exhibit a treatment-specific response .\
CONCLUSIONS	Larger , more definitive , investigations to evaluate treatment-specific effects on multiple sensory and affective pain descriptors , and prediction of treatment response by these descriptors , will advance efforts toward developing and implementing more effective individualized pain therapies .\
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###16467647\
OBJECTIVE	To assess whether dietary intervention in free-living healthy subjects is effective in improving blood pressure levels .\
METHODS	Open randomised , controlled trial .\
METHODS	Free-living healthy subjects in two rural villages in north-eastern Japan .\
METHODS	Five hundred and fifty healthy volunteers aged 40-69 years .\
METHODS	Tailored dietary education to encourage a decrease in sodium intake and an increase in the intake of vitamin C and carotene , and of fruit and vegetables .\
METHODS	Blood pressure , dietary intake and urinary excretion of sodium , dietary carotene and vitamin C , and fruit and vegetable intake data were collected at 1 year after the start of the intervention .\
RESULTS	During the first year , changes differed significantly between the intervention and control groups for dietary ( P = 0.002 ) and urinary excretion ( P < 0.001 ) of sodium and dietary vitamin C and carotene ( P = 0.003 ) .\
RESULTS	Systolic blood pressure decreased from 127.9 to 125.2 mmHg ( 2.7 mmHg decrease ; 95 % confidence interval , -4.6 to -0.8 ) in the intervention group , whereas it increased from 128.0 to 128.5 mmHg ( 0.5 increase ; -1.3 to 2.3 ) in the control group .\
RESULTS	This change was statistically significant ( P = 0.007 ) .\
RESULTS	In contrast , the change in diastolic blood pressure did not significantly differ between the groups .\
RESULTS	In hypertensive subjects , a significant difference in systolic blood pressure reduction was seen between the groups ( P = 0.032 ) .\
CONCLUSIONS	Moderate-intensity dietary counseling in free-living healthy subjects achieved significant dietary changes , which resulted in a significant decrease in systolic blood pressure .\
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###18827177\
BACKGROUND	To hasten cancer drug development , new paradigms are needed to assess therapeutic efficacy .\
BACKGROUND	In a randomized phase II study in patients with renal cell carcinoma , 10 microg/kg bevacizumab ( Avastin ; Genentech , Inc. , South San Francisco , CA ) administered every 2 weeks resulted in a longer time to progression but a statistically significant difference in overall survival could not be demonstrated .\
METHODS	We developed a novel two-phase equation to estimate concomitant rates of tumor regression ( regression rate constant ) and tumor growth ( growth rate constant ) .\
METHODS	This method allows us to assess therapeutic efficacy using tumor measurements gathered while a patient receives therapy in a clinical trial .\
RESULTS	The growth rate constants of renal cell carcinomas were significantly lower during therapy with 10 microg/kg bevacizumab than those of tumors in patients receiving placebo .\
RESULTS	In all cohorts the tumor growth rate constants were correlated with survival .\
RESULTS	That a survival advantage was not demonstrated with bevacizumab appears to have been a result of early discontinuation of bevacizumab .\
CONCLUSIONS	Single-agent bevacizumab significantly affects the growth rate constants of renal cell carcinoma .\
CONCLUSIONS	Extrapolating from the growth rate constants , we conclude that the failure to demonstrate a survival advantage in the original study was a result of premature discontinuation of bevacizumab .\
CONCLUSIONS	The mathematical model described herein has applications to many tumor types and should aid in evaluating the relative efficacies of different therapies .\
CONCLUSIONS	Quantitating tumor growth rate constants using data gathered while patients are enrolled in a clinical trial , as in the present study , may streamline and assist in drug development .\
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###19678781\
OBJECTIVE	There is increasing evidence that intake of sour tea ( Hibiscus sabdariffa ) has hypoglycemic and hypolipidemic effects and may benefit patients suffering from metabolic disorders such as diabetes .\
OBJECTIVE	The objective of the present study was to investigate the hypolipidemic effects of sour tea in patients with diabetes and compare them with those of black tea .\
METHODS	In this sequential randomized controlled clinical trial , 60 patients with diabetes were recruited and randomly assigned into two groups : sour tea ( ST ) and black tea ( BT ) .\
METHODS	They were instructed to consume sour tea or black tea two times a day for 1 month .\
METHODS	Fasting blood samples were taken at the beginning and at the end of the study for evaluation of lipids , lipoproteins , and apoproteins .\
RESULTS	Fifty-three ( 53 ) patients concluded the study .\
RESULTS	In the ST group , mean of high-density lipoprotein-cholesterol ( HDLc ) increased significantly ( p = 0.002 ) at the end of the study , whereas changes in apolipoprotein-A1 , and lipoprotein ( a ) were not significant .\
RESULTS	Also , a significant decrease in the mean of total cholesterol , low density lipoprotein-cholesterol , triglycerides , and Apo-B100 were seen in this group .\
RESULTS	In the BT group , only HDLc showed significant change ( p = 0.002 ) at the end of the study and changes in the other measures were not statistically significant .\
CONCLUSIONS	The results of the present study showed that ST has a significant effect on blood lipid profile in patients with diabetes .\
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###8382104\
BACKGROUND	Influence of tamoxifen treatment on estrogen receptor ( ER ) and progesterone receptor ( PR ) levels in human breast cancer has not been fully elucidated in vivo .\
BACKGROUND	This problem was studied in 20 postmenopausal patients with ER-positive and PR-positive primary breast cancer .\
METHODS	Each patient underwent two fine-needle aspiration ( FNA ) biopsies .\
METHODS	Between two FNA , 10 patients received no treatment ( control group ) and the other 10 patients were given tamoxifen ( 20 mg/day ) for an average of 8 days ( range , 6-10 days ) ( TAM group ) .\
METHODS	Total ER and PR values ( cytosolic plus nuclear fraction ) in FNA samples were determined by enzyme immunoassay ( EIA ) for detecting ER and PR regardless of their occupancy with corresponding ligands .\
RESULTS	In the control group , no significant difference was found in ER and PR values between the first and second FNA samples .\
RESULTS	In the TAM group , ER and PR values ( mean + / - standard error of the mean [ SEM ] fmol/mg DNA ) in the second FNA samples were 605 + / - 186 and 1130 + / - 344 , respectively , and were significantly higher ( P < 0.05 ) than ER and PR values in the first FNA samples , which were 312 + / - 74 and 639 + / - 159 , respectively .\
RESULTS	ER and PR values increased by 201 + / - 27 % and 163 + / - 23 % , respectively , on an individual basis after tamoxifen treatment .\
CONCLUSIONS	These results demonstrated that tamoxifen up-regulates ER and PR in human breast cancer .\
\
###9010709\
OBJECTIVE	The effect of short-term heat exposure in a Finnish sauna on hepatic first-pass metabolism and the capacity to metabolize midazolam were studied in a crossover trial .\
OBJECTIVE	Midazolam oral ( 15 mg ) and intravenous ( 0.05 mg.kg-1 ) was given to 6 healthy young male volunteers , in random order , during a control session and a sauna bathing session ( temperature 85-100 degrees C , relative humidity 25-30 % ) .\
OBJECTIVE	Blood samples for the determination of plasma midazolam and alpha-hydroxy midazolam concentrations were taken for 6 h after drug administration .\
RESULTS	After oral administration , the bioavailability and clearance of midazolam were not affected by sauna bathing , nor was there a significant difference in alpha-hydroxy midazolam plasma concentration or the alpha-hydroxy midazolam/midazolam AUC-ratio between the sessions .\
RESULTS	Midazolam Cmax was increased and its t1/2 beta was prolonged during the sauna session , but the clinical relevance of the findings appears to be modest .\
RESULTS	The pharmacokinetics of intravenous midazolam were not affected by sauna bathing .\
CONCLUSIONS	Short-term heat exposure may not affect the first-pass metabolism or hepatic capacity to metabolize midazolam .\
\
###16965419\
BACKGROUND	There is a lack of consensus as to the best way of monitoring psoriasis severity in clinical trials .\
BACKGROUND	The Psoriasis Area and Severity Index ( PASI ) is the most frequently used system and the Physician 's Global Assessment ( PGA ) is also often used .\
BACKGROUND	However , both instruments have some drawbacks and neither has been fully evaluated in terms of ` validity ' and ` reliability ' as a psoriasis rating scale .\
BACKGROUND	The Lattice System Physician 's Global Assessment ( LS-PGA ) scale has recently been developed to address some disadvantages of the PASI and PGA .\
OBJECTIVE	To evaluate the inter-rater and intrarater reliability of the PASI , PGA and LS-PGA .\
METHODS	On the day before the study , 14 dermatologists ( raters ) , with varied experience of assessing psoriasis , received detailed training ( 2.5 h ) on use of the scales .\
METHODS	On the study day , each rater evaluated 16 adults with chronic plaque psoriasis in the morning and again in the afternoon .\
METHODS	Raters were randomly assigned to assess subjects using the scales in a specific sequence , either PGA , LS-PGA , PASI or PGA , PASI , LS-PGA .\
METHODS	Each rater used one sequence in the morning and the other in the afternoon .\
METHODS	The primary endpoint was the inter-rater and intrarater reliability as determined by intraclass correlation coefficients ( ICCs ) .\
RESULTS	All three scales demonstrated ` substantial ' ( a priori defined as ICC > 80 % ) intrarater reliability .\
RESULTS	The inter-rater reliability for each of the PASI and LS-PGA was also ` substantial ' and for the PGA was ` moderate ' ( ICC 75 % ) .\
CONCLUSIONS	Each one of the three scales provided reproducible psoriasis severity assessments .\
CONCLUSIONS	In terms of both intrarater and inter-rater reliability values , the three scales can be ranked from highest to lowest as follows : PASI , LS-PGA and PGA .\
\
###11298069\
OBJECTIVE	1 ) To characterize the variability of multiple-dose halofantrine pharmacokinetics over time in healthy adults , 2 ) to correlate the pharmacodynamic measure electrocardiographic ( ECG ) QT interval with ( + ) - and ( - ) - halofantrine plasma concentration and 3 ) to evaluate the safety and tolerance of halofantrine hydrochloride given over time to healthy adults .\
METHODS	Twenty-one healthy subjects were enrolled and 13 completed the study ( 180 days ) .\
METHODS	Subjects received either 500 mg of racemic halofantrine once daily in the fasted state for 42 days , or placebo , and then halofantrine washout was documented for the following 138 days .\
METHODS	Pharmacokinetic and pharmacodynamic ( ECG QTc ) measurements were obtained .\
RESULTS	Mean accumulation half-times ( days ) for halofantrine were : 7.0 + / - 4.8 [ ( + ) - halofantrine ] and 7.3 + / - 4.8 [ ( - ) - halofantrine ] .\
RESULTS	Mean steady-state concentrations were : 97.6 + / - 52.0 ng ml ( -1 ) [ ( + ) - halofantrine ] and 48.5 + / - 20.8 [ ( - ) - halofantrine ] .\
RESULTS	Steady-state oral clearance was : 139 + / - 73 l h ( -1 ) [ ( + ) - halofantrine ] and 265 + / - 135 l h ( -1 ) [ ( - ) - halofantrine ] .\
RESULTS	Peak plasma concentrations of both ( + ) - and ( - ) - halofantrine were attained at 6 h and maximal ECG QTc prolongation was at 4-8 h following drug administration .\
RESULTS	Fourteen of 16 subjects who received active drug had ECG QTc prolongation that was positively correlated with both ( + ) - and ( - ) - halofantrine concentration .\
RESULTS	The five subjects who received placebo had no demonstrable change in ECG QTc throughout the study .\
RESULTS	Conclusions Halofantrine accumulates extensively and shows high intersubject pharmacokinetic variability , is associated with concentration-related ECG QTc prolongation in healthy subjects , and is clinically well tolerated in this subject group .\
\
###21932661\
OBJECTIVE	To evaluate effectiveness of low-level laser therapy ( LLLT ) on temporomandibular joint ( TMJ ) pain .\
METHODS	The patients with TMJ pain were randomly assigned laser group ( n = 21 ) or control group ( n = 21 ) , once a day for 6 consecutive days of treatment .\
METHODS	TMJ pain and function were measured at baseline , just after treatment course , 1 month and 2 months after the treatment .\
RESULTS	The changes of visual analogue scale ( VAS ) were appearing over time in both groups but presented statistically significant differences between groups ( P < 0.001 ) .\
RESULTS	VAS of laser group decreased faster than that of control group .\
RESULTS	The same tendency occurred for painless maximum vertical opening ( MVO ) , left lateral excursion ( LLE ) and right lateral excursion ( RLE ) , which increased faster in laser group .\
RESULTS	There were no statistically significant differences between groups and evaluation times for protrusion excursion ( PE ) , but an interaction between group and evaluation times existed and should be explored further .\
CONCLUSIONS	LLLT is an appropriate treatment for TMJ pain .\
\
###22553403\
OBJECTIVE	To prospectively confirm whether a small amount of polyethylene glycol ( PEG ) ingested after swallowing endoscopy capsule improves image quality and completion rate .\
METHODS	Forty-four consecutive patients referred to us for capsule endoscopy ( CE ) were randomized to two groups .\
METHODS	All patients were restricted to clear fluids for 12 h before the examination .\
METHODS	Patients in group A ( 22 cases ) received no additional preparation , while those in group B ( 20 cases ) ingested 500 mL of PEG within a 2 h period starting 30 min after swallowing the capsule .\
METHODS	Clear fluids and meals were allowed 2 h and 4 h after capsule ingestion , respectively .\
METHODS	Image quality was assessed as the percentage of visualized bowel surface area as follows : 1 : < 25 % ; 2 : 25 % -49 % ; 3 : 50 % -74 % ; 4 : 75 % -89 % ; 5 : > 90 % .\
METHODS	The small bowel record was divided into five segments by time , and the score for each segment was evaluated .\
METHODS	All CE examinations were performed with the Pillcam SB capsule endoscopy system ( Given Imaging Co. Ltd. , Yoqnem ) .\
RESULTS	This study ended in December 2009 , because sample size was considered large enough .\
RESULTS	A total of 44 patients were enrolled .\
RESULTS	Two patients in group B were excluded from the analysis because small bowel images could not be obtained from these patients ; one had a full stomach , while the other presented with a massive gastric bleed .\
RESULTS	Thus , 22 patients from group A and 20 patients from group B completed the study .\
RESULTS	There was no significant difference in age ( P = 0.22 ) , sex ( P = 0.31 ) , and indication for CE .\
RESULTS	No significant adverse events occurred in any of the study patients .\
RESULTS	In group A , image quality deteriorated as the capsule progressed distally .\
RESULTS	However , in group B , image quality was maintained to the distal small bowel .\
RESULTS	In each of the five segments , the visibility score was significantly higher in group B than in group A ( segment 1 : 4.3 0.7 vs 4.7 0.5 , P = 0.03 ; segment 2 : 4.2 0.9 vs 4.8 0.4 , P = 0.01 ; segment 3 : 4.0 1.0 vs 4.6 0.7 , P = 0.04 ; segment 4 : 3.6 1.1 vs 4.5 0.6 , P = 0.003 ; segment 5 : 2.7 1.0 vs 4.4 0.8 , P = 0.00004 ) .\
RESULTS	Thus , the use of PEG during CE examination significantly improved image quality in all time segments , and this effect was more pronounced in the distal ileum .\
RESULTS	The completion rate to the cecum was not significantly different between groups A and B ( 81.8 % vs 85.0 % , P = 0.89 ) .\
RESULTS	There was no difference in the gastric transit time between groups ( 36.2 35.0 min vs 54.0 56.6 min , P = 0.23 ) , but the small bowel transit time was significantly longer in group A than in group B ( 246.0 107.0 min vs 171.0 104.0 min , P = 0.04 ) .\
CONCLUSIONS	The ingestion of a small amount of PEG after the swallowing of an endoscopy capsule significantly improved CE image quality , but did not enhance the completion rate to the cecum .\
\
###16630994\
OBJECTIVE	This study sought to determine the long-term safety and efficacy of co-administered fenofibrate ( FENO ) and ezetimibe ( EZE ) in patients with mixed hyperlipidemia .\
BACKGROUND	Both EZE and FENO offer complementary benefits to the lipid profile of patients with mixed hyperlipidemia .\
METHODS	After completing the 12-week randomized , double-blind base study that compared EZE 10 mg , FENO 160 mg , FENO 160 mg plus EZE 10 mg , and placebo in patients with mixed hyperlipidemia , patients continued into a double-blind , 48-week extension phase .\
METHODS	Those patients in the FENO plus EZE and FENO groups continued on their respective base study treatment , and patients in the EZE and placebo groups were switched to FENO plus EZE and FENO , respectively .\
RESULTS	Of the 587 patients who completed the base study , 576 continued into the extension study ( n = 340 in FENO plus EZE and n = 236 in FENO ) .\
RESULTS	The FENO plus EZE produced significantly greater reductions in low-density lipoprotein-cholesterol compared with FENO ( -22 % vs. -9 % , respectively ; p < 0.001 ) .\
RESULTS	There were also significantly greater improvements in triglycerides , high-density lipoprotein cholesterol ( HDL-C ) , total cholesterol , non-HDL-C , and apolipoprotein B with FENO plus EZE compared with FENO .\
RESULTS	Changes in apolipoprotein A-I and high-sensitivity C-reactive protein were similar between groups .\
RESULTS	Overall , FENO plus EZE was well tolerated during the extension study .\
RESULTS	The proportion of patients with consecutive elevations of alanine aminotransferase/aspartate aminotransferase > or = 3 times upper limit of normal were similar between the FENO plus EZE ( 1.2 % ) and FENO ( 1.7 % ) groups .\
RESULTS	No cases of creatine phosphokinase elevations > or = 10 times upper limit of normal or myopathy were observed in either group .\
CONCLUSIONS	Long-term , 48-week co-administration of FENO plus EZE was well tolerated and more efficacious than FENO in patients with mixed hyperlipidemia .\
\
###23002282\
BACKGROUND	Pertuzumab , a humanized monoclonal antibody targeting human epidermal growth factor receptor ( HER ) - mediated signalling , has shown activity in ovarian cancer in preclinical models and in the clinic .\
BACKGROUND	This randomized phase II study evaluated efficacy and safety of pertuzumab in combination with carboplatin-based chemotherapy in patients with platinum-sensitive , recurrent advanced ovarian cancer .\
METHODS	Patients were randomized to receive six cycles of chemotherapy ( carboplatin and either paclitaxel ( Taxol ) or gemcitabine ) with or without pertuzumab .\
METHODS	The primary end point was progression-free survival ( PFS ) as determined by Response Evaluation Criteria in Solid Tumors and/or by CA 125 measurements .\
METHODS	Secondary end points evaluated the response rate , safety profile , duration of response , time to progression and overall survival for both treatment arms .\
RESULTS	A total of 149 patients received either chemotherapy with pertuzumab ( arm A , n = 74 ) or chemotherapy alone ( arm B , n = 75 ) .\
RESULTS	There was no significant difference either in median PFS or in the secondary end points between the two arms .\
RESULTS	No differences were seen in an exploratory biomarker analysis of HER3 mRNA expression between the two arms .\
RESULTS	Pertuzumab was well tolerated , with no increase in cardiac adverse events compared with chemotherapy alone .\
CONCLUSIONS	The addition of pertuzumab to carboplatin-based chemotherapy did not substantially prolong PFS in unselected patients with platinum-sensitive ovarian cancer .\
\
###16736729\
BACKGROUND	The histamine catabolite , Nalpha-methylhistamine , possesses a selective affinity for H3 receptors .\
BACKGROUND	For this reason , we considered evaluating the efficacy of this histaminergic H3 agonist in migraine prophylactic treatment .\
OBJECTIVE	To study the therapeutic potential of the subcutaneous administration of Nalpha-methylhistamine in migraine prophylaxis , in a Phase III clinical pharmacological study .\
METHODS	Using a controlled double-blind , placebo controlled clinical trial for 12 weeks , 60 patients with migraine , who fit the criteria established by the International Headache Society , were selected .\
METHODS	The efficacy of subcutaneous administration of Nalpha-methylhistamine 1 to 3 ng twice a week against placebo was studied , evaluating the outcome of headache intensity , frequency , duration , and analgesic intake .\
RESULTS	Comparison between the groups treated with placebo ( n = 30 ) and Nalpha-methylhistamine ( n = 30 ) , on data collected for the 4th , 8th and 12th weeks of treatment , revealed that Nalpha-methylhistamine exerted a significant ( p < 0.0001 ) reduction ( compared to placebo ) in intensity , frequency , and duration of migraine attacks , as well as on the use of analgesic intake .\
RESULTS	No significant ( p > 0.05 ) adverse experiences or side effects developed in either group .\
CONCLUSIONS	The present study provides evidence of the efficacy of Nalpha-methylhistamine , given subcutaneously at doses of 1 to 3 ng twice a week , offering a new therapeutic alternative and laying the clinical and pharmacological groundwork for the use of histaminergic H3-agonists in migraine prophylaxis , which may specifically inhibit the neurogenic edema response involved in migraine pathophysiology .\
\
###18474338\
BACKGROUND	Strategies to preserve renal function and enhance diuretic responsiveness during therapy for heart failure ( HF ) are needed .\
BACKGROUND	We hypothesized that brain natriuretic peptide ( nesiritide ) added to standard HF therapy would preserve renal function and enhance diuretic responsiveness .\
METHODS	Patients with HF with underlying renal dysfunction who were admitted with volume overload were randomized to standard therapy with nesiritide ( 2 mug/kg bolus ; 0.01 mug/kg/min for 48 hours ) or without nesiritide .\
METHODS	Patients requiring intravenous vasodilator or inotropic therapy for rapid symptom relief were ineligible .\
METHODS	In all patients , diuretics were administered according to a standardized dosing algorithm .\
RESULTS	Patients ( n = 72 ) had a mean creatinine level of 1.75 + / - 0.59 mg/dL .\
RESULTS	Patients receiving nesiritide had a lesser increase in creatinine ( P = .048 ) and blood urea nitrogen ( P = .02 ) , but a greater reduction in blood pressure ( P < .01 ) .\
RESULTS	Nesiritide did not enhance diuretic responsiveness ( P = .57 ) but increased 3 ' 5 ' cyclic guanosine monophosphate and decreased endothelin more ( P < .05 for both ) .\
RESULTS	There were no differences in the change in atrial natriuretic peptide , N-terminal pro-brain natriuretic peptide , plasma renin activity , angiotensin II , and aldosterone between groups .\
CONCLUSIONS	When used as adjuvant `` renal protective '' therapy in patients with HF with renal dysfunction , the recommended dose of nesiritide reduced blood pressure , did not seem to worsen renal function , and suppressed endothelin but did not enhance diuretic responsiveness or prevent activation of the renin-angiotensin-aldosterone system .\
\
###7647823\
OBJECTIVE	Since little information is available on the capacity of the non-obese to adapt to a moderate decrease in energy intake , the effect of a 10-week moderately energy-restricted diet ( ER ) on energy expenditure and body composition was studied .\
METHODS	A controlled intervention study .\
METHODS	After a weight-maintaining run-in period of 2 weeks , the ER group received a diet that contained 9.2 MJ/day on average , i.e. 80 % of the energy of their habitual diet ( estimated by means of a 7-day dietary record ) for the next ten weeks while the control group received the weight-maintaining diet .\
METHODS	Subjects continued daily life habits and came to the Institute every evening to have dinner and to receive food for the next 24 h.\
METHODS	24 healthy non-obese , middle-aged men participated .\
METHODS	Subjects were matched for age and body mass index and randomly assigned to a control group ( n = 8 ) or an ER group ( n = 16 ) .\
RESULTS	Average daily metabolic rate ( ADMR , i.e. total energy expenditure ) , measured with doubly labeled water in eight subjects of the ER group , appeared to be 82.5 % of reported energy intake resulting in an actual level of energy restriction in these eight subjects of 33 % on average ( range 18-42 % ) , rather than 20 % .\
RESULTS	Subjects in the ER group lost 7.4 + / - 1.7 kg ; 83 % of this weight loss was fat mass , 17 % was fat-free mass .\
RESULTS	Subjects in the control group lost some weight too ( 2.1 + / - 1.5 kg ) .\
RESULTS	Resting metabolic rate ( RMR ) ( MJ/day ) decreased in the ER group ( P < 0.001 ) .\
RESULTS	In this group the thyroid hormone triiodothyronine ( T3 ) decreased ( P < 0.001 ) , while reverse T3 ( rT3 ) increased ( P < 0.05 ) .\
RESULTS	ADMR decreased significantly .\
CONCLUSIONS	Under conditions of a controlled moderately energy-restricted diet in daily life a significant weight loss can be induced , similar to that observed after a balanced dietary deficit , providing 5 MJ/day .\
CONCLUSIONS	In addition , moderate energy restriction induces a decrease in fat-free mass and a fall in RMR .\
\
###15874923\
OBJECTIVE	To assess whether a pragmatic policy of perioperative beta-blockade , with metoprolol , reduced the 30-day cardiovascular morbidity and mortality and reduced the length of hospital stay in average patients undergoing infrarenal vascular surgery .\
METHODS	This was a double-blind randomized placebo-controlled trial that occurred in vascular surgical units in four UK hospitals .\
METHODS	Participants were 103 patients without previous myocardial infarction who had infrarenal vascular surgery between July 2001 and March 2004 .\
METHODS	Interventions were oral metoprolol ( 50 mg twice daily , supplemented by intravenous doses when necessary ) or placebo from admission until 7 days after surgery .\
METHODS	Holter monitors were kept in place for 72 hours after surgery .\
RESULTS	Eighty men and 23 women ( median age , 73 years ) were randomized , 55 to metoprolol and 48 to placebo , and 97 ( 94 % ) underwent surgery during the trial .\
RESULTS	The most common operations were aortic aneurysm repair ( 38 % ) and distal bypass ( 29 % ) .\
RESULTS	Intraoperative inotropic support was required in 64 % and 92 % of patients in the placebo and metoprolol groups , respectively .\
RESULTS	Within 30 days , cardiovascular events occurred in 32 patients , including myocardial infarction ( 8 % ) , unstable angina ( 9 % ) , ventricular tachycardia ( 19 % ) , and stroke ( 1 % ) .\
RESULTS	Four ( 4 % ) deaths were reported .\
RESULTS	Cardiovascular events occurred in 15 ( 34 % ) and 17 ( 32 % ) patients in the placebo and metoprolol groups , respectively ( unadjusted relative risk , 0.94 ; 95 % confidence interval , 0.53-1 .66 ; adjusted [ for age , sex , statin use , and aortic cross-clamping ] relative risk , 0.87 ; 95 % confidence interval , 0.48-1 .55 ) .\
RESULTS	Time from operation to discharge was reduced from a median of 12 days ( 95 % confidence interval , 9-19 days ) in the placebo group to 10 days ( 95 % confidence interval , 8-12 days ) in the metoprolol group ( adjusted hazard ratio , 1.71 ; 95 % confidence interval , 1.09-2 .66 ; P < .02 ) .\
CONCLUSIONS	Myocardial ischemia was evident in a high proportion ( one third ) of the patients after surgery .\
CONCLUSIONS	A pragmatic regimen of perioperative beta-blockade with metoprolol did not seem to reduce 30-day cardiovascular events , but it did decrease the time from surgery to discharge .\
\
###24957431\
OBJECTIVE	To determine expression of apoptotic factors p53 and caspase-8 in human lens epithelial cells ( LECs ) of cataract patients with or without diabetic retinopathy ( DR ) , the duration of diabetes mellitus ( DM ) , and the level of glycated hemoglobin ( hemoglobin A1c [ HbA1c ] ) .\
METHODS	St. Mary 's Hospital , Catholic University of Korea , Seoul , South Korea .\
METHODS	Randomized prospective study .\
METHODS	The LECs were isolated during cataract surgery .\
METHODS	The isolated samples were classified into 4 groups as follows : patients without DM ( Group 1 ) , patients with DM but not DR ( Group 2 ) , diabetic patients with nonproliferative DR ( Group 3 ) , and diabetic patients with proliferative DR ( Group 4 ) .\
METHODS	To explore the mechanism of apoptosis , the expressions of p53 and caspase-8 were measured by immunohistochemical staining and compared with the data according to the duration of DM , HbA1c levels , and severity of DR.\
RESULTS	All groups comprised 15 eyes .\
RESULTS	The expressions of P53 and caspase-8 were higher in Groups 2 , 3 , and 4 than in Group 1 ( P < .001 ) .\
RESULTS	The expressions were statistically significantly increased with a longer duration of DM , higher HbA1c levels , and advanced DR.\
CONCLUSIONS	The expressions of P53 and caspase-8 were strong in patients with DM and advanced DR. Knowledge of these relationships may lead to a better understanding of the development of diabetic cataract .\
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .\
\
###21422467\
BACKGROUND	Platelet-rich plasma ( PRP ) has been shown to be a general stimulation for repair and 1-year results showed promising success percentages .\
OBJECTIVE	This trial was undertaken to determine the effectiveness of PRP compared with corticosteroid injections in patients with chronic lateral epicondylitis with a 2-year follow-up .\
METHODS	Randomized controlled trial ; Level of evidence , 1 .\
METHODS	The trial was conducted in 2 Dutch teaching hospitals .\
METHODS	One hundred patients with chronic lateral epicondylitis were randomly assigned to a leukocyte-enriched PRP group ( n = 51 ) or the corticosteroid group ( n = 49 ) .\
METHODS	Randomization and allocation to the trial group were carried out by a central computer system .\
METHODS	Patients received either a corticosteroid injection or an autologous platelet concentrate injection through a peppering needling technique .\
METHODS	The primary analysis included visual analog scale ( VAS ) pain scores and Disabilities of the Arm , Shoulder and Hand ( DASH ) outcome scores .\
RESULTS	The PRP group was more often successfully treated than the corticosteroid group ( P < .0001 ) .\
RESULTS	Success was defined as a reduction of 25 % on VAS or DASH scores without a reintervention after 2 years .\
RESULTS	When baseline VAS and DASH scores were compared with the scores at 2-year follow-up , both groups significantly improved across time ( intention-to-treat principle ) .\
RESULTS	However , the DASH scores of the corticosteroid group returned to baseline levels , while those of the PRP group significantly improved ( as-treated principle ) .\
RESULTS	There were no complications related to the use of PRP .\
CONCLUSIONS	Treatment of patients with chronic lateral epicondylitis with PRP reduces pain and increases function significantly , exceeding the effect of corticosteroid injection even after a follow-up of 2 years .\
CONCLUSIONS	Future decisions for application of PRP for lateral epicondylitis should be confirmed by further follow-up from this trial and should take into account possible costs and harms as well as benefits .\
\
###11012909\
BACKGROUND	Bicarbonate-buffered replacement fluid ( RF-bic ) in continuous venovenous hemofiltration ( CVVH ) may be superior to lactate-buffered replacement fluid ( RF-lac ) in acute renal failure .\
BACKGROUND	In an open , randomized , multicenter study , we investigated the effects of RF-bic and RF-lac on cardiovascular outcome in patients requiring CVVH following acute renal failure .\
METHODS	One hundred seventeen patients between the age of 18 and 80 years were randomized to CVVH either with RF-bic ( N = 61 ) or RF-lac ( N = 56 ) .\
METHODS	Patients were treated with CVVH for five days or until either renal function was restored or the patient was removed from the study .\
METHODS	Data were analyzed on day 5 or according to the `` last observation carried forward '' ( LOCF ) option .\
METHODS	Adverse events were classified according to the WHO-Adverse Reaction Terminology system .\
RESULTS	Blood lactate levels were significantly lower and blood bicarbonate levels were significantly higher in patients treated with RF-bic than in those treated with RF-lac ( lactate , 17.4 + / - 8.5 vs. 28.7 + / - 10.4 mg/dL , P < 0.05 ; bicarbonate , 23.7 + / - 0.4 vs. 21.8 + / - 0.5 mmol/L , P < 0.01 ) .\
RESULTS	The number of hypotensive crises was lower in RF-bic-treated patients than in RF-lac-treated patients ( RF-bic 14 out of 61 patients , RF-lac in 29 out of 56 patients ; 0.26 + / - 0.09 vs. 0.60 + / - 0.31 episodes per 24 h , P < 0.05 ) .\
RESULTS	Nine out of 61 patients ( 15 % ) treated with RF-bic and 21 out of 56 patients ( 38 % ) treated with RF-lac developed cardiovascular events during CVVH therapy ( P < 0.01 ) .\
RESULTS	A multiple regression analysis showed that the occurrence of cardiovascular events was dependent on replacement fluid and previous cardiovascular disease and not on age or blood pressure .\
RESULTS	Patients with cardiac failure died less frequently in the group treated with RF-bic ( 7 out of 24 , 29 % ) than in the group treated with RF-lac ( 12 out of 21 , 57 % , P = 0.058 ) .\
RESULTS	In patients with septic shock , lethality was comparable in both groups ( RF-bic , 10 out of 27 , 37 % ; RF-lac , 7 out of 20 , 35 % , P = NS ) .\
CONCLUSIONS	The results show that the administration of RF-bic solution was superior in normalizing acidosis of patients without the risk of alkalosis .\
CONCLUSIONS	The data also suggest that the use of RF-bic during CVVH reduces cardiovascular events in critically ill patients with acute renal failure , particularly those with previous cardiovascular disease or heart failure .\
\
###24474552\
OBJECTIVE	Energy drinks are beverages containing vasoactive metabolites , usually a combination of caffeine , taurine , glucuronolactone and sugars .\
OBJECTIVE	There are concerns about the safety of energy drinks with some countries banning their sales .\
OBJECTIVE	We determined the acute effects of a popular energy drink , Red Bull , on cardiovascular and hemodynamic variables , cerebrovascular parameters and microvascular endothelial function .\
METHODS	Twenty-five young non-obese and healthy subjects attended two experimental sessions on separate days according to a randomized crossover study design .\
METHODS	During each session , primary measurements included beat-to-beat blood pressure measurements , impedance cardiography and transcranial Doppler measurements for at least 20min baseline and for 2h following the ingestion of either 355mL of the energy drink or 355mL of tap water ; the endothelial function test was performed before and two hours after either drink .\
RESULTS	Unlike the water control load , Red Bull consumption led to increases in both systolic and diastolic blood pressure ( p < 0.005 ) , associated with increased heart rate and cardiac output ( p < 0.05 ) , with no significant changes in total peripheral resistance and without diminished endothelial response to acetylcholine ; consequently , double product ( reflecting myocardial load ) was increased ( p < 0.005 ) .\
RESULTS	Red Bull consumption also led to increases in cerebrovascular resistance and breathing frequency ( p < 0.005 ) , as well as to decreases in cerebral blood flow velocity ( p < 0.005 ) and end-tidal carbon dioxide ( p < 0.005 ) .\
CONCLUSIONS	Our results show an overall negative hemodynamic profile in response to ingestion of the energy drink Red Bull , in particular an elevated blood pressure and double product and a lower cerebral blood flow velocity .\
\
###19753739\
BACKGROUND	Itraconazole is an oral antifungal agent , which has been proved to be effective in pityriasis versicolor .\
BACKGROUND	Different regimens for the treatment of pityriasis versicolor have been studied and good results were obtained with short-term treatment regimens .\
OBJECTIVE	To compare the efficacy and tolerability of the classical regimen of 200 mg/day itraconazole for 5 days with the regimens of 400 mg/day for 1 and 3 days .\
METHODS	A total of 60 patients with pityriasis versicolor were recruited into a randomized study .\
METHODS	The patients were divided into three groups , each composed of 20 people .\
METHODS	Mycological and clinical assessments were done before and on the 7th and 28th days after the treatment .\
METHODS	Results were evaluated with the chi-squared test .\
RESULTS	The regimen of 400 mg/day itraconazole for 3 days was found to be as effective as the classical regimen of 200 mg/day for 5 days in the treatment of pityriasis versicolor .\
RESULTS	The regimen of 400 mg/day itraconazole for 1 day was found to be ineffective .\
CONCLUSIONS	This study has shown that a short course of itraconazole , 400 mg/day for 3 days , appears to be an effective and alternative treatment for pityriasis versicolor .\
\
###8410407\
OBJECTIVE	To determine the characteristics of good peer reviewers .\
METHODS	Cross-sectional analysis of data gathered during a randomized controlled trial .\
METHODS	The Journal of General Internal Medicine .\
METHODS	226 reviewers of 131 consecutively submitted manuscripts of original research .\
METHODS	201 ( 91 % ) completed the review and submitted a curriculum vitae .\
RESULTS	The quality of each review was judged on a scale from 1 to 5 by an editor who was blinded to the identity of the reviewer .\
RESULTS	Reviewer characteristics were taken from the curricula vitae .\
RESULTS	86 of the 201 reviewers ( 43 % ) produced good reviews ( a grade of 4 or 5 ) .\
RESULTS	Using logistic regression , the authors found that when a reviewer was less than 40 years old , from a top academic institution , well known to the editor choosing the reviewer , and blinded to the identity of the manuscript 's authors , the probability that he or she would produce a good review was 87 % , whereas a reviewer without any of these characteristics had a 7 % probability of producing a good review .\
RESULTS	Other characteristics that were significant only on bivariate analysis included previous clinical research training , additional postgraduate degrees , and more time spent on the review .\
RESULTS	There was a negative but statistically nonsignificant association between academic rank and review quality : 37 % of full professors , 39 % of associate professors , and 51 % of assistant professors or fellows produced good reviews ( p = 0.11 ) .\
CONCLUSIONS	Good peer reviewers for this journal tended to be young , from strong academic institutions , well known to the editors , and blinded to the identity of the manuscript 's authors .\
\
###11798687\
OBJECTIVE	To study the effects of Xuezhikang on lipid profile , thromboxane ( TX ) A ( 2 ) , prostacyclin ( PGI ( 2 ) ) in patients with hyperlipidemia .\
METHODS	91 patients with hyperlipidemia were randomly divided into a treatment group ( n = 47 , Xuezhikang 1.2 g/d Bid , p.o ) and control group ( n = 44 , gemfibrozil 1.2 g/d Bid , p.o ) .\
METHODS	serum lipids , TXB ( 2 ) and 6-Keto-PGF ( 1alpha ) were determined before and 8 weeks after the treatment .\
RESULTS	( 1 ) After 8 weeks of treatment , the level of serum total cholesterol ( TC ) and low density lipoprotein cholesterol ( LDL-C ) decreased by 21.6 % ( P < 0.01 ) and 33.3 % ( P < 0.01 ) in the Xuezikang group and by 20.4 % ( P < 0.01 ) and 24.8 % ( P < 0.01 ) in the gemfibrozil group respectively .\
RESULTS	Serum high density lipoprotein cholesterol ( HDL-C ) level elevated by 33.7 % in the Xuezhikang group ( P < 0.01 ) and 26.9 % in the gemfibrozil group ( P < 0.01 ) .\
RESULTS	The effect of Xuezhikang was the same as gemfibrozil .\
RESULTS	There was no statistically significant difference between the effects of these two drugs .\
RESULTS	Triglyceride ( TG ) level decreased by 23.3 % in the Xuezhikang group ( P < 0.01 ) and 40.3 % in the gemfibrozil group ( P < 0.01 ) .\
RESULTS	TG lowering effect of gemfibrozil was superior to that of Xuezhikang ( P < 0.05 ) .\
RESULTS	( 2 ) The level of lipoprotein ( a ) [ LP ( a ) ] in the plasma decreased by 28.2 % ( P < 0.01 ) in the Xuezhikang group and by 4.9 % ( P > 0.05 ) in the gemfibrozil group .\
RESULTS	LP ( a ) lowering effect of Xuezhikang was superior to that of gemfibrozil ( P < 0.01 ) .\
RESULTS	( 3 ) The Level of thromboxane ( TX ) B ( 2 ) in the plasma decreased by 34.2 % in the Xuezhikang group ( P < 0.01 ) and by 8.4 % in the gemfibrozil group ( P < 0.01 ) .\
RESULTS	TXB ( 2 ) lowering effect of Xuezhikang was superior to that of gemfibrozil ( P < 0.01 ) .\
RESULTS	The level of 6-KetO-PGF ( 1alpha ) in the plasma elevated by 65.4 % in the Xuezhikang group ( P < 0.01 ) and by 11.7 % in the gemfibrozil group ( P < 0.01 ) ; the effect of Xuezhikang was superior to that of gemfibrozil ( P < 0.01 ) .\
CONCLUSIONS	Xuezhikang could markedly decrease the level of TC and LDL-C and elevate that of HDL-C in patients with hyperlipidemia and the effects of Xuezhikang were the same as those of gemfibrozil .\
CONCLUSIONS	TG lowering effect of gemfibrozil was superior to that of Xuezhikang , but Xuezhikang could markedly decrease the level of Lp ( a ) and regluate the balance between TXA ( 2 ) and PGI ( 2 ) , its effect being superior to that of gemfibrozil .\
\
###22036512\
OBJECTIVE	To evaluate the impact of a copper-containing intrauterine contraceptive device ( IUCD ) and the levonorgestrel-releasing intrauterine system ( IUS ) on puerperal and menstrual bleeding when fitted intraoperatively during scheduled elective cesarean .\
METHODS	Participants were allocated to 3 groups : cesarean with no device inserted ; IUCD inserted during cesarean ; and IUS inserted during cesarean .\
RESULTS	There was significantly shorter and lighter puerperium in the IUS group ( 20.2 7.7 days and 3.1 1.6 pads/day ) than in the IUCD ( 33.4 9.5 days and 4.9 2.4 pads/day ) and the control ( 27.0 11.4 days and 4.9 2.3 pads/day ) groups ( P < 0.012 and P < 0.0001 , respectively ) .\
RESULTS	At the end of puerperium , mean duration of amenorrhea was significantly longer in the IUS group than in the IUCD and control groups ( P < 0.0001 ) .\
RESULTS	Menstrual periods were longer and heavier in the IUCD group than in the control group but the difference was not significant ( P > 0.07 ) .\
RESULTS	In the IUS group , menstrual periods were significantly shorter and lighter than in the other groups ( P < 0.0001 ) .\
CONCLUSIONS	Intrauterine system fitting at the time of elective cesarean is associated with significant reductions in the duration and amount of puerperal blood loss , as well as a high incidence of amenorrhea and lighter periods thereafter .\
\
###23179965\
BACKGROUND	Cannabinoids have been shown to alter time perception , but existing literature has several limitations .\
BACKGROUND	Few studies have included both time estimation and production tasks , few control for subvocal counting , most had small sample sizes , some did not record subjects ' cannabis use , many tested only one dose , and used either oral or inhaled administration of - tetrahydrocannabinol ( THC ) , leading to variable pharmacokinetics , and some used whole-plant cannabis containing cannabinoids other than THC .\
BACKGROUND	Our study attempted to address these limitations .\
OBJECTIVE	This study aims to characterize the acute effects of THC and frequent cannabis use on seconds-range time perception .\
OBJECTIVE	THC was hypothesized to produce transient , dose-related time overestimation and underproduction .\
OBJECTIVE	Frequent cannabis smokers were hypothesized to show blunted responses to these alterations .\
METHODS	IV THC was administered at doses from 0.015 to 0.05 mg/kg to 44 subjects who participated in several double-blind , randomized , counterbalanced , crossover , placebo-controlled studies .\
METHODS	Visual time estimation and production tasks in the seconds range were presented to subjects three times on each test day .\
RESULTS	All doses induced time overestimation and underproduction .\
RESULTS	Chronic cannabis use had no effect on baseline time perception .\
RESULTS	While infrequent/nonsmokers showed temporal overestimation at medium and high doses and temporal underproduction at all doses , frequent cannabis users showed no differences .\
RESULTS	THC effects on time perception were not dose related .\
CONCLUSIONS	A psychoactive dose of THC increases internal clock speed as indicated by time overestimation and underproduction .\
CONCLUSIONS	This effect is not dose related and is blunted in chronic cannabis smokers who did not otherwise have altered baseline time perception .\
\
###17367439\
OBJECTIVE	To assess the efficacy of vardenafil in a population of Spanish men with erectile dysfunction ( ED ) , its influence on patients ' self-esteem and self-confidence , and its effect on their quality of life .\
METHODS	Efficacy was assessed by the International Index of Erectile Function-Erectile Function ( IIEF-EF ) domain , the Rosenberg Self-Esteem scale , the Johnson and McCoy Self-Confidence scale , the Medical Outcome Short Form ( SF-36 ) scale , items 2 and 3 of the Sexual Encounter Profile questionnaire , and the Global Assessment Question ( GAQ ) .\
METHODS	Safety assessments included laboratory tests , physical exam , electrocardiogram , vital signs , and adverse events .\
METHODS	This was a randomized , double-blind , multicenter , placebo-controlled study .\
METHODS	After a 4-week treatment-free period , patients received flexible-dose vardenafil or placebo for 12 weeks .\
METHODS	The initial dose was 10 mg , which could be titrated up to 20 mg or down to 5 mg at weeks 4 and 8 .\
RESULTS	A total of 121 patients were included in the intention-to-treat analysis ( 61 on vardenafil and 60 on placebo ) .\
RESULTS	Of these , 16 in the vardenafil group and 14 in the placebo group had severe ED .\
RESULTS	There was a greater improvement in IIEF-EF domain score with vardenafil vs. placebo for all patients ( score change of 10.9 vs. 1.6 , respectively , P < 0.001 ) and for patients with severe ED ( score change of 13.4 vs. 2.2 , respectively , P = 0.011 ) .\
RESULTS	A significant difference in favor of vardenafil was also observed for positive responses to the GAQ ( 73.8 % vs. 25.0 % , P < 0.001 ) .\
RESULTS	After 12 weeks , vardenafil-treated patients with severe ED showed a significant improvement in their self-esteem compared with patients receiving placebo ( change from baseline -1.51 vs. 3.54 , respectively , P = 0.036 ) .\
RESULTS	Vardenafil treatment was well tolerated .\
CONCLUSIONS	Vardenafil was highly effective for improving EF in all patients with ED , and resulted in significant improvements in self-esteem in patients with severe ED .\
\
###16686813\
BACKGROUND	The use of chronic opioids for noncancer pain is an increasingly common and difficult problem in primary care .\
OBJECTIVE	To test the effects on physicians ' self-reported attitudes and behavior of a shared decision-making training for opioid treatment of chronic pain .\
METHODS	Randomized-controlled trial .\
METHODS	Internal Medicine residents ( n = 38 ) and attendings ( n = 7 ) were randomized to receive two 1-hour training sessions on a shared decision-making model for opioid treatment for chronic pain ( intervention , n = 22 ) or written educational materials ( control , n = 23 ) .\
METHODS	Questionnaires assessing physician satisfaction , physician patient-centeredness , opioid prescribing practices , and completion rates of patient treatment agreements administered 2 months before and 3 months after training .\
RESULTS	At follow-up , the intervention group reported significantly greater overall physician satisfaction ( P = .002 ) , including subscales on relationship quality ( P = .03 ) and appropriate use of time ( P = .02 ) , self-reported completion rates of patient treatment agreements ( P = .01 ) , self-reported rates of methadone prescribing ( P = .05 ) , and self-reported change in care of patients with chronic pain ( P = .01 ) .\
CONCLUSIONS	Training primary care physicians in the shared decision-making model improves physician satisfaction in caring for patients with chronic pain and promotes the use of patient treatment agreements .\
CONCLUSIONS	Further research is necessary to determine whether this training improves patient satisfaction and outcomes .\
\
###15220729\
OBJECTIVE	To study the efficacy and safety of amniotic membrane transplantation as an adjunctive therapy after surgical excision of primary pterygium and to compare the clinical outcome with that of conjunctival autograft .\
METHODS	Eighty-six eyes of 78 patients with primary pterygium were operated on by a single surgeon ( N.T. ) .\
METHODS	All patients were randomized to undergo amniotic membrane or conjunctival autograft transplantation as an adjuvant therapy after pterygium excision .\
METHODS	Forty-four eyes in 39 patients were treated with amniotic membrane transplantation ( AM group ) , and 42 eyes of 41 patients were treated with conjunctival autograft ( CG group ) .\
METHODS	Patients were followed up at 1 week , 1 , 3 , 6 , and 12 months postoperation .\
METHODS	The main outcome measurement was a recurrence rate after surgery .\
RESULTS	The mean follow-up was 14.40 + / - 5.4 months in the AM group and 12.35 + / - 3.13 months in the CG group .\
RESULTS	There were 18 recurrences ( 40.9 % ) in the AM group and two ( 4.76 % ) in the CG group , which was significantly different among both groups ( P < 0.007 ) .\
RESULTS	The cumulative proportion that were recurrence-free at 12 months was 0.6 + / - 0.15 for the AM group and 0.95 + / - 0.07 for the CG group ( P = 0.0003 , Log-rank test ) .\
RESULTS	The cumulative nonrecurrence rate at 6 and 12 months in all patients stratified by age and sex was not significantly different ( P = 0.28 and P = 0.9 , Log-rank test ) .\
RESULTS	No major complications were observed in either group .\
CONCLUSIONS	The surgical results of primary pterygium excision followed by amniotic membrane and conjunctival autograft transplantation were compared .\
CONCLUSIONS	It was found that amniotic membrane transplantation for pterygium surgery has an unacceptably high recurrence rate .\
\
###25219351\
OBJECTIVE	To investigate potential drug-drug interactions between topiramate and metformin and pioglitazone at steady state .\
METHODS	Two open-label studies were performed in healthy adult men and women .\
METHODS	In Study 1 , eligible participants were given metformin alone for 3 days ( 500 mg twice daily [ BID ] ) followed by concomitant metformin and topiramate ( titrated to 100mg BID ) from days 4 to 10 .\
METHODS	In Study 2 , eligible participants were randomly assigned to treatment with pioglitazone 30 mg once daily ( QD ) alone for 8 days followed by concomitant pioglitazone and topiramate ( titrated to 96 mg BID ) from days 9 to 22 ( Group 1 ) or to topiramate ( titrated to 96 mg BID ) alone for 11 days followed by concomitant pioglitazone 30 mg QD and topiramate 96 mg BID from days 12 to 22 ( Group 2 ) .\
METHODS	An analysis of variance was used to evaluate differences in pharmacokinetics with and without concomitant treatment ; 90 % confidence intervals ( CI ) for the ratio of the geometric least squares mean ( LSM ) estimates for maximum plasma concentration ( Cmax ) , area under concentration-time curve for dosing interval ( AUC12 or AUC24 ) , and oral clearance ( CL/F ) with and without concomitant treatment were used to assess a drug interaction .\
RESULTS	A comparison to historical data suggested a modest increase in topiramate oral clearance when given concomitantly with metformin .\
RESULTS	Coadministration with topiramate reduced metformin oral clearance at steady state , resulting in a modest increase in systemic metformin exposure .\
RESULTS	Geometric LSM ratios and 90 % CI for metformin CL/F and AUC12 were 80 % ( 75 % , 85 % ) and 125 % ( 117 % , 134 % ) , respectively .\
RESULTS	Pioglitazone had no effect on topiramate pharmacokinetics at steady state .\
RESULTS	Concomitant topiramate resulted in decreased systemic exposure to pioglitazone and its active metabolites , with geometric LSM ratios and 90 % CI for AUC24 of 85.0 % ( 75.7 % , 95.6 % ) for pioglitazone , 40.5 % ( 36.8 % , 44.6 % ) for M-III , and 83.8 % ( 76.1 % , 91.2 % ) for M-IV , respectively .\
RESULTS	This effect appeared more pronounced in women than in men .\
RESULTS	Coadministration of topiramate with metformin or pioglitazone was generally well tolerated by healthy participants in these studies .\
CONCLUSIONS	A modest increase in metformin exposure and decrease in topiramate exposure was observed at steady state following coadministration of metformin 500 mg BID and topiramate 100mg BID .\
CONCLUSIONS	The clinical significance of the observed interaction is unclear but is not likely to require a dose adjustment of either agent .\
CONCLUSIONS	Pioglitazone 30 mg QD did not affect the pharmacokinetics of topiramate at steady state , while coadministration of topiramate 96 mg BID with pioglitazone decreased steady-state systemic exposure to pioglitazone , M-III , and M-IV .\
CONCLUSIONS	While the clinical consequence of this interaction is unknown , careful attention should be given to the routine monitoring for adequate glycemic control of patients receiving this concomitant therapy .\
CONCLUSIONS	Concomitant administration of topiramate with metformin or pioglitazone was generally well tolerated and no new safety concerns were observed .\
\
###24467802\
BACKGROUND	Overweight and obesity are associated with an increased risk of morbidity .\
BACKGROUND	Mindfulness training could be an effective strategy to optimize lifestyle behaviors related to body weight gain .\
BACKGROUND	The aim of this study was to evaluate the effectiveness of a worksite mindfulness-based multi-component intervention on vigorous physical activity in leisure time , sedentary behavior at work , fruit intake and determinants of these behaviors .\
BACKGROUND	The control group received information on existing lifestyle behavior - related facilities that were already available at the worksite .\
METHODS	In a randomized controlled trial design ( n = 257 ) , 129 workers received a mindfulness training , followed by e-coaching , lunch walking routes and fruit .\
METHODS	Outcome measures were assessed at baseline and after 6 and 12 months using questionnaires .\
METHODS	Physical activity was also measured using accelerometers .\
METHODS	Effects were analyzed using linear mixed effect models according to the intention-to-treat principle .\
METHODS	Linear regression models ( complete case analyses ) were used as sensitivity analyses .\
RESULTS	There were no significant differences in lifestyle behaviors and determinants of these behaviors between the intervention and control group after 6 or 12 months .\
RESULTS	The sensitivity analyses showed effect modification for gender in sedentary behavior at work at 6-month follow-up , although the main analyses did not .\
CONCLUSIONS	This study did not show an effect of a worksite mindfulness-based multi-component intervention on lifestyle behaviors and behavioral determinants after 6 and 12 months .\
CONCLUSIONS	The effectiveness of a worksite mindfulness-based multi-component intervention as a health promotion intervention for all workers could not be established .\
\
###22397833\
OBJECTIVE	The purpose of the present study was to evaluate the effects of a school-based , 2-year , multi-component intervention on BMI , eating and physical activity behaviour in Flanders , Belgium , targeting children aged 3-6 years in communities of high and low socio-economic status ( SES ) .\
METHODS	Cluster-randomized controlled trial .\
METHODS	Thirty-one pre-primary and primary schools in three different intervention communities and three paired-matched ( on SES profile ) control communities in Flanders , Belgium .\
METHODS	BMI Z-scores at baseline and follow-up were calculated for 1102 children .\
METHODS	Questionnaires with sociodemographic data and FFQ were available from 694 of these 1102 children .\
RESULTS	No significant effects were found on BMI Z-scores for the total sample .\
RESULTS	However , there was a significant decrease in BMI Z-score of 011 in the low-SES intervention community compared with the low-SES control community , where the BMI Z-score increased by 004 ( F = 626 , P = 001 ) .\
RESULTS	No significant intervention effects could be found for eating behaviour , physical activity or screen-time .\
RESULTS	There were no significant interaction effects of age and gender of the children on the outcome variables .\
CONCLUSIONS	Although no significant effects were found for BMI Z-scores in the total sample , this intervention had a promising effect in the low-SES community of reducing excess weight gain among young children .\
\
###12890209\
BACKGROUND	Treatment failures and relapses are not uncommon in onychomycosis .\
BACKGROUND	Therefore , it is worthwhile to consider the combination of systemic and topical antifungals to improve the cure rates further and to reduce the duration of systemic treatment .\
OBJECTIVE	To evaluate and compare itraconazole pulse therapy combined with amorolfine with itraconazole alone in the treatment of Candida fingernail onychomycosis .\
METHODS	Ninety patients with moderate to severe Candida fingernail onychomycosis were randomized into two treatment groups of 45 subjects each .\
METHODS	Group 1 received itraconazole pulse therapy for 2 months and applied amorolfine 5 % solution nail lacquer for 6 months , while group 2 received monotherapy with three pulses of itraconazole .\
METHODS	The primary efficacy criterion was the result of mycological examination at 3 months .\
METHODS	The secondary criterion was the combined mycological and clinical response at 9 months .\
METHODS	A pharmacoeconomic analysis was also performed to compare the cost-effectiveness of combined therapy vs. monotherapy .\
RESULTS	Eighty-five patients were analysed ( 73 women and 12 men , mean + / - SD age 44.2 + / - 12.9 years ) .\
RESULTS	Patients had a mean + / - SD of 3.64 + / - 2.0 nails involved and 228.6 + / - 148.0 mm2 of their nail surface diseased .\
RESULTS	The mean duration of onychomycosis was 11 months .\
RESULTS	Paronychial involvement was evident in 71 patients .\
RESULTS	C. albicans was isolated in 85 cases , C. parapsilosis in three and other Candida species in two cases .\
RESULTS	Side-effects were uncommon and in only one case led to withdrawal .\
RESULTS	At the 3-month visit , mycological cure was seen in 32 ( 74 % ) of 43 patients in group 1 and in 25 ( 60 % ) of 42 patients in group 2 .\
RESULTS	At the 9-month visit , a global cure was seen in 40 patients ( 93 % ) in group 1 and in 34 patients ( 81 % ) in group 2 .\
RESULTS	Statistical analysis showed no statistically significant difference ( P > 0.1 ) between the two treatment groups .\
RESULTS	The cost per cure ratio was 1.63 and 1.70 euro for groups 1 and 2 , respectively .\
CONCLUSIONS	The combination of amorolfine and oral itraconazole , which interfere with different steps of ergosterol synthesis , exhibited substantial synergy .\
CONCLUSIONS	Compared with oral itraconazole alone , the combination achieved greater mycological cure and increased total cure rate .\
CONCLUSIONS	However , no statistically significant difference was documented for this number of observations .\
CONCLUSIONS	Combination treatment with amorolfine and two pulses of itraconazole is at least as safe and effective as three pulses of itraconazole , with a lower cost per patient .\
CONCLUSIONS	In our opinion , the addition of amorolfine to oral itraconazole pulse therapy is of value in the treatment of moderate to severe Candida fingernail onychomycosis .\
\
###23230072\
OBJECTIVE	Intravenous cannulation is a widespread medical procedure that can be difficult in children .\
OBJECTIVE	Visualization of veins with near-infrared ( NIR ) light might support intravenous cannulation .\
OBJECTIVE	Therefore , we investigated the effectiveness of an NIR vascular imaging system ( VascuLuminator ) in facilitating intravenous cannulation in children in the operating room .\
METHODS	This was a pragmatic , cluster randomized clinical trial in all consecutive children ( 0-18 years ) scheduled for elective surgery and in need of intravenous cannulation at a tertiary pediatric referral hospital .\
METHODS	Daily operating rooms ( 770 patients ) were randomized for allocation of the VascuLuminator or control group .\
METHODS	The primary outcome was success at first attempt ; the secondary outcome was time to successful cannulation .\
RESULTS	Success at first attempt was 70 % ( 171/246 ) with and 71 % ( 175/245 ) without the use of the VascuLuminator ( P = .69 ) .\
RESULTS	Time to successful cannulation was 162 ( 14 ) seconds and 143 ( 15 ) seconds respectively ( P = .26 ) .\
RESULTS	In 83.3 % , the vein of first choice was visible with the VascuLuminator .\
CONCLUSIONS	Although it was possible to visualize veins with NIR in most patients , the VascuLuminator did not improve success rate or time to obtain intravenous cannulation .\
CONCLUSIONS	There are 3 possible explanations for this result : first , it could be that localization of the vein is not the main problem , and therefore visualization is not a solution ; second , the type of system used in this study could be less than optimal ; and , third , the choice of the patient population in this study could be inappropriate .\
\
###16430794\
OBJECTIVE	Data on the effectiveness of cyclooxygenase 2 inhibitors in postoperative pain therapy vary widely .\
OBJECTIVE	We tested in a prospective , placebo-controlled , randomized , double-blind trial the hypotheses that perioperative ( i.e. preoperative and postoperative ) administration of the cyclooxygenase 2 inhibitor rofecoxib decreases pain scores and morphine consumption after spine , breast and orthopaedic surgery .\
METHODS	Five hundred and forty patients scheduled for spine , breast or orthopaedic surgery were randomly assigned to receive in combination with postoperative morphine via patient controlled analgesia pump for 4 days either rofecoxib 50 mg administered perioperatively , rofecoxib 50 mg administered only postoperatively , or placebo .\
METHODS	Primary outcome criteria were pain score at rest ( numeric rating scale 0-4 ) and morphine consumption .\
RESULTS	Perioperative rofecoxib significantly decreased pain score 0 ( 0-1 ) vs. 1 ( 0-2 ) ( median ( interquartile range ) ) , and morphine consumption 18 ( 6-33 ) vs. 22.5 ( 12-38 ) compared with placebo .\
RESULTS	In contrast , rofecoxib when administered only postoperatively did not significantly improve analgesic effects or side-effects at time of assessment of the main criteria ( 24 h after skin closure ) , but during the follow-up period at 48 h and 72 h after skin closure pain scores and morphine consumption were improved compared to placebo .\
RESULTS	The analgesic effects of rofecoxib were independent from the type of surgery .\
CONCLUSIONS	Perioperative administration of the cyclooxygenase 2 inhibitor rofecoxib decreases pain scores and morphine consumption after orthopaedic , breast and spine surgery .\
CONCLUSIONS	However , the benefit of preoperative administration of the cyclooxygenase 2 inhibitor seems to be only moderate , suggesting that early postoperative administration may be a useful alternative approach .\
CONCLUSIONS	There is no evidence that the type of surgery influences analgesic effects of cyclooxygenase 2 inhibitors .\
\
###24508285\
OBJECTIVE	To compare the clinical effectiveness of a newly developed cognitive behavioural self-management manual delivered by specialist heart failure nurses or the same programme followed by the patient on their own , in terms of readmissions/admissions to hospital for any reason within a 12 month period , patient health related quality of life , self-management and carer quality of life .\
METHODS	Pragmatic , open parallel group , randomised controlled trial .\
METHODS	Open access heart failure diagnostic clinics and primary care .\
METHODS	260 patients with a definitive diagnosis of symptomatic heart failure ( LVSD ) as defined by ECHO , clinical diagnosis or coronary angiography were eligible for the study .\
METHODS	A newly developed nurse facilitated , cognitive behavioural self-management programme was developed and was delivered either by a heart failure nurse or by the patient on their own .\
METHODS	Patient admission/readmission to hospital for any reason within a 12 month period following randomisation .\
METHODS	Secondary outcomes were : participant health related quality of life as measured by the Minnesota Living with Heart Failure questionnaire , the Hospital , Anxiety and Depression Scale , the European self-care form .\
RESULTS	There was no evidence of a difference between the groups in whether or not a patient was re-admitted to hospital during the 12 month follow-up period ( p = 0.66 ) .\
RESULTS	There was no evidence of a difference between the treatment groups in the mean MLHF scores over time ( p = 0.768 ) , the European self-care questionnaire ( p = 0.340 ) or the mean HAD anxiety score ( p = 0.786 ) .\
RESULTS	However , when adjusted for baseline scores the self-management group had a statistically significant higher HADS depression score at 12 months ( p = 0.003 ) .\
CONCLUSIONS	There was no evidence of a difference in admissions/readmission to hospital between patients who undertook a brief heart failure self-management programme facilitated by a specialist heart failure nurse and those also receiving care from a specialist nurse who followed the programme on their own .\
BACKGROUND	This trial is registered as ISRCTN84692046 .\
\
###21992121\
BACKGROUND	Idiopathic pulmonary fibrosis is a progressive lung disease with a high mortality rate .\
BACKGROUND	Because the signaling pathways activated by several tyrosine kinase receptors have been shown to be involved in lung fibrosis , it has been suggested that the inhibition of these receptors may slow the progression of idiopathic pulmonary fibrosis .\
METHODS	In a 12-month , phase 2 trial , we assessed the efficacy and safety of four different oral doses of the tyrosine kinase inhibitor BIBF 1120 as compared with placebo in patients with idiopathic pulmonary fibrosis .\
METHODS	The primary end point was the annual rate of decline in forced vital capacity ( FVC ) .\
METHODS	Secondary end points included acute exacerbations , quality of life ( measured with the St. George 's Respiratory Questionnaire [ SGRQ ] ) , and total lung capacity .\
RESULTS	A total of 432 patients underwent randomization to receive one of four doses of BIBF 1120 ( 50 mg once a day , 50 mg twice a day , 100 mg twice a day , or 150 mg twice a day ) or placebo .\
RESULTS	In the group receiving 150 mg of BIBF 1120 twice a day , FVC declined by 0.06 liters per year , as compared with 0.19 liters per year in the placebo group , a 68.4 % reduction in the rate of loss with BIBF 1120 ( P = 0.06 with the closed testing procedure for multiplicity correction ; P = 0.01 with the hierarchical testing procedure ) .\
RESULTS	This dose also resulted in a lower incidence of acute exacerbations , as compared with placebo ( 2.4 vs. 15.7 per 100 patient-years , P = 0.02 ) and a small decrease in the SGRQ score ( assessed on a scale of 0 to 100 , with lower scores indicating better quality of life ) as compared with an increase with placebo ( -0.66 vs. 5.46 , P = 0.007 ) .\
RESULTS	Gastrointestinal symptoms ( which led to more discontinuations in the group receiving 150 mg twice a day than in the placebo group ) and increases in levels of liver aminotransferases were more frequent in the group receiving 150 mg of BIBF 1120 twice daily than in the placebo group .\
CONCLUSIONS	In patients with idiopathic pulmonary fibrosis , BIBF 1120 at a dose of 150 mg twice daily , as compared with placebo , was associated with a trend toward a reduction in the decline in lung function , with fewer acute exacerbations and preserved quality of life .\
CONCLUSIONS	( Funded by Boehringer Ingelheim ; ClinicalTrials.gov number , NCT00514683 . )\
\
###16555167\
OBJECTIVE	The objective of this double-blind , randomised , placebo-controlled , multicentre clinical study was to demonstrate the non-inferiority and safety of the hypericum extract STW3-VI in a once-daily dosage regime in the treatment of moderate depression .\
OBJECTIVE	During the 6-week treatment phase , the course of depression was documented by use of HAMD ( items 1-17 ) , the von Zerssen 's Adjective Mood Scale ( BfS ) and the CGI scales .\
OBJECTIVE	The primary objective of this 3-arm design study was to demonstrate the non-inferiority of hypericum extract STW3-VI ( 900 mg ) to the SSRI citalopram ( 20 mg ) and superiority of hypericum over placebo .\
METHODS	Outpatients ( N = 388 ) suffering from moderate depression were enrolled .\
METHODS	The safety and tolerability of hypericum extract in comparison to citalopram and placebo was investigated on the basis of CGI , the occurrence of adverse events and the investigation of laboratory parameters and vital signs .\
RESULTS	From almost identical baseline values of 21.9 + / - 1.2 points ( hypericum extract ) , 21.8 + / - 1.2 points ( citalopram ) and 22.0 + / - 1.2 points ( placebo ) , the HAMD score was reduced to 10.3 + / - 6.4 ( hypericum extract ) , 10.3 + / - 6.4 ( citalopram ) and 13.0 + / - 6.9 ( placebo ) , respectively .\
RESULTS	Based on this data , the statistical significant therapeutic equivalence of hypericum extract STW3-VI to citalopram ( p < 0.0001 ) and the superiority of this hypericum extract over placebo ( p < 0.0001 ) was demonstrated .\
RESULTS	At the end of treatment 54.2 % ( hypericum extract ) , 55.9 % ( citalopram ) and 39.2 % ( placebo ) of the patients were assessed as therapy responders .\
RESULTS	The secondary efficacy parameters , change in BfS , CGI and amount of therapy responders showed that the hypericum group was not statistically different from the citalopram group , and significantly superior to the placebo group .\
RESULTS	Significantly more adverse events with `` certain '' , `` probable '' or `` possible '' relation to study medication were documented in the citalopram group ( hypericum : 17.2 % , citalopram : 53.2 % , placebo : 30 % ) .\
RESULTS	In most cases , the investigators assessed the tolerability of hypericum extract , citalopram and placebo as `` good '' or `` very good '' .\
CONCLUSIONS	The non-inferiority of hypericum extract as compared to citalopram and the superiority of both active compounds to placebo were demonstrated , as well as a better safety and tolerability of hypericum extract in comparison to citalopram .\
CONCLUSIONS	These results revealed that hypericum extract STW3-VI is a good alternative to chemically defined antidepressants in the treatment of outpatients with moderate depression .\
\
###16231620\
BACKGROUND	Coronary artery bypass graft surgery ( CABG ) using cardiopulmonary bypass ( CPB ) is assumed to be associated with a decline of neurocognitive functions .\
BACKGROUND	This study was designed to analyse the neurocognitive function of patients with coronary heart disease before and after CABG and to determine possible protective effects of oxygenator surface coating on neurological outcome .\
METHODS	Forty patients scheduled for selective CABG were prospectively randomized into two groups of 20 patients each according to the type of hollow-fibre membrane oxygenator used .\
METHODS	Non-coated oxygenators ( Group A ) were compared to phosphorylcholine ( PC ) coated oxygenators ( Group B ) .\
METHODS	A battery of six neurological tests was administered preoperatively , 7-10 days and 4-6 months after surgery .\
RESULTS	One patient of Group A suffered from a perioperative stroke and died on postoperative day 3 , presumably because of sudden heart failure .\
RESULTS	Two patients of Group A ( 10 % ) developed a symptomatic transitory delirious psychotic syndrome ( STPT ) on postoperative days 3 and 5 .\
RESULTS	None of the patients of Group B had perioperative complications .\
RESULTS	The test analysis revealed a trend of declined neurocognitive function early after CABG , but did not show any difference in neurocognitive outcome between the two groups .\
CONCLUSIONS	PC coating of the oxygenators did not show any significant benefit on neurocognitive function after CABG using CPB .\
\
###11840792\
BACKGROUND	Combined topical and intracameral anesthesia has become increasingly popular in cataract surgery .\
BACKGROUND	We analyzed the use of intracameral anesthesia in patients with corneal dystrophy who had undergone cataract surgery .\
METHODS	We measured the number of endothelial cells in 40 eyes with Fuchs ' corneal endothelial dystrophy preoperatively as well as three times postoperatively ( after 1 day , 4 weeks , and 3 months ) .\
METHODS	Performing sponge anesthesia , the additional application of 0.15 ml lidocaine 1 % was randomized .\
RESULTS	The lidocaine group showed the following loss of endothelial cells in the central cornea : 1 day postoperatively 9.2 % , 4 weeks later 9.7 % , and 3 months after surgery 10.7 % .\
RESULTS	The other group had a postoperative loss of endothelial cells in the central cornea of 8.8 % ( 1 day ) , 9.3 % ( 4 weeks ) , and 10.5 % ( 3 months ) .\
RESULTS	No significant differences between the two groups were observed .\
CONCLUSIONS	Cornea guttata is not a contraindication for the use of intraocular lidocaine .\
\
###24885942\
BACKGROUND	High levels of circulating fibroblast growth factor 23 ( FGF23 ) are associated with chronic kidney disease ( CKD ) progression and high mortality .\
BACKGROUND	In the Phosphate Reduction Evaluation of FGF23 in Early CKD Treatment ( PREFECT ) study , we assessed the effect of reducing intestinal phosphate absorption using lanthanum carbonate on FGF23 levels in normophosphatemic patients with CKD stage 3 .\
METHODS	Thirty-five individuals were randomized to lanthanum carbonate 3000 mg/day ( n = 23 ) or placebo ( n = 12 ) for 12 weeks .\
METHODS	Levels of intact FGF23 ( iFGF23 ) , C-terminal FGF23 , serum and urinary phosphate and calcium , intact parathyroid hormone and 1,25-dihydroxyvitamin D were assessed .\
RESULTS	The median age was 65 years in the lanthanum group and 73 years in the placebo group ; 58.8 % and 41.7 % were men , respectively .\
RESULTS	No significant difference was seen in mean iFGF23 between groups at week 12 .\
RESULTS	There was , however , a transient reduction from baseline in iFGF23 in the lanthanum group at week 1 , from 70.5 pg/ml to 51.9 pg/ml , which was not seen in the placebo group ; this between-group difference in percentage change from baseline was significant in post hoc analyses ( p = 0.0102 ) .\
RESULTS	Urinary phosphate decreased after 1 week of lanthanum treatment and remained low at week 12 .\
CONCLUSIONS	Reducing intestinal phosphate absorption with lanthanum carbonate did not lead to sustained reductions in iFGF23 in patients with CKD stage 3 , although phosphaturia decreased .\
CONCLUSIONS	This suggests that factors other than phosphate burden may be responsible for driving increases in circulating FGF23 in patients with CKD .\
BACKGROUND	ClinicalTrials.gov NCT01128179 , 20 May 2010 .\
\
###8537805\
BACKGROUND	Beta-agonist agents have been used for bronchospasm and cough in a variety of settings .\
BACKGROUND	We sought to evaluate the efficacy of oral albuterol for acute cough in ambulatory adults .\
METHODS	We performed a prospective , randomized , controlled , double-blind clinical trial comparing albuterol 4 mg by mouth three times daily for 7 days with placebo in 104 adults .\
METHODS	Subjects had cough of less than 4 weeks ' duration and no evidence of pneumonia , asthma , or chronic obstructive pulmonary disease .\
METHODS	All subjects were enrolled at the walk-in clinic of a rural academic medical center .\
RESULTS	There was no significant difference between treated and control subjects in any measure of efficacy including cough severity score , reduction in sleepless nights , utilization of health care , or return to full activity .\
RESULTS	There were significantly more reports of `` shakiness '' and `` nervousness '' among albuterol-treated subjects than among controls .\
CONCLUSIONS	Oral albuterol should not be used in unselected patients with acute , nonspecific cough .\
\
###19240178\
OBJECTIVE	Successful treatment of acute myeloid leukemia ( AML ) remains a therapeutic challenge , with a high percentage of patients suffering from persistent or relapsed disease .\
OBJECTIVE	Resistance to drug therapy can develop from increased drug export and/or altered intracellular signaling .\
OBJECTIVE	Both mechanisms are mediated by the efflux transporters ABCC4 ( MRP4 ) , ABCC5 ( MRP5 ) , and ABCC11 ( MRP8 ) , which are involved in cellular efflux of endogenous signaling molecules ( e.g. , cyclic adenosine 3 ' , 5 ' - monophosphate and cyclic guanosine 3 ' ,5 ' - monophosphate ) and nucleoside analogues .\
OBJECTIVE	The nucleoside analogue cytosine arabinoside ( AraC ) is administered to all patients with AML .\
METHODS	Expression of ABCC transporters MRP4 , MRP5 , and MRP8 in blast samples from 50 AML patients was investigated by real-time reverse transcription-PCR analysis and correlated with clinical outcome measures .\
METHODS	Accumulation of radiolabeled AraC , transport of AraC metabolites , and AraC cytotoxicity were analyzed in MRP8-transfected LLC-PK1 cells .\
RESULTS	Regression analysis revealed that high expression of MRP8 is associated with a low probability of overall survival assessed over 4 years ( P < 0.03 ) .\
RESULTS	MRP8-transfected LLC-PK1 cells accumulated reduced intracellular levels of AraC ( 63 % of the parental vector-transfected LLC-PK1 control cells ) as well as AraC metabolites .\
RESULTS	Furthermore , AraC monophosphate was transported by MRP8-enriched membrane vesicles ( 116 + / -6 versus 65 + / -13 pmol/mg/10 minutes by control vesicles ) , and MRP8-transfected cells were resistant to AraC .\
CONCLUSIONS	These data suggest that MRP8 is differentially expressed in AML blasts , that expression of MRP8 serves as a predictive marker for treatment outcome in AML , and that efflux of AraC metabolites by MRP8 is a mechanism that contributes to resistance of AML blasts .\
\
###15094031\
OBJECTIVE	( a ) To evaluate the effect of a cognitive-behavioural inpatient treatment and ( b ) to analyse the differential efficacy of an additional ( `` soma '' ) group management training of somatisation .\
METHODS	The final sample consisted of 191 patients with somatisation syndrome ( patients with at least eight DSM-IV somatoform symptoms ) .\
METHODS	Patients were randomly assigned to ( I ) `` standard treatment + soma '' or ( II ) `` standard treatment + relaxation training . ''\
METHODS	A waiting control group consisted of 34 patients .\
METHODS	All patients were diagnosed with a structured clinical interview for DSM-IV and received an interview on medical consulting behaviour and questionnaires concerning somatoform symptoms , general psychopathology , subjective health status , and life satisfaction .\
RESULTS	Results show high impairment of the sample prior to treatment .\
RESULTS	At the 1-year follow-up , all outcome criteria were significantly reduced .\
RESULTS	The differential effect of the additional soma treatment was significant only for a reduction of visits to the doctor .\
RESULTS	Greatest longitudinal effect sizes were found for the reduction of somatoform symptoms .\
CONCLUSIONS	Considering the subjects ' high initial impairment , the outcome results are encouraging .\
CONCLUSIONS	The specific effect on health care use highlights the socioeconomic relevance .\
\
###10525592\
OBJECTIVE	Muscle relaxants have different pharmacodynamic profiles in various muscles .\
OBJECTIVE	Therefore , results obtained for one muscle can not be extrapolated to other muscles .\
OBJECTIVE	In the adductor pollicis muscle cisatracurium exerts a pharmacodynamic profile comparable to atracurium , despite the known difference in onset time .\
OBJECTIVE	However , studies evaluating the neuromuscular effect of cisatracurium in different muscles are lacking .\
OBJECTIVE	Accordingly , this study compares the pharmacodynamic profile of cisatracurium and atracurium in the orbicularis oculi muscle ( OO ) - which shows a neuromuscular course similar to the diaphragm and the laryngeal muscles - and the adductor pollicis muscle ( AP ) .\
METHODS	Forty-five patients ( ASA I-II ) , scheduled for elective spinal surgery were anaesthetized with propofol and fentanyl .\
METHODS	Endotracheal intubation was performed without using a muscle relaxant .\
METHODS	Neuromuscular transmission was monitored using acceleromyography in both muscles .\
METHODS	Patients received 0.1 mg/kg ( 2x ED ( 95 ) ) or 0.15 mg/kg ( 3x ED ( 95 ) ) cisatracurium , or 0.5 mg/kg atracurium ( 2x ED ( 95 ) ) at random .\
METHODS	Onset and recovery times were measured according to the recommendation of the Copenhagen Consensus Conference .\
RESULTS	Onset time was significantly shorter in the OO than in the AP following 0.15 mg/kg cisatracurium and 0.5 mg/kg atracurium ( P < 0.05 ) .\
RESULTS	No differences in onset time between the two muscles were found after 0.1 mg/kg cisatracurium .\
RESULTS	The recovery of T ( 1 ) to 10 % of its control was completed sooner in the OO than in the AP in all three groups ( P < 0.05 ) .\
CONCLUSIONS	Cisatracurium shows a dose-dependent shorter onset time in the OO than in the AP .\
CONCLUSIONS	This is consistent with the current view that the onset of non-depolarizing neuromuscular blockers is more rapid in the OO than in the AP .\
CONCLUSIONS	However , at least a dose of 3x ED ( 95 ) of cisatracurium was necessary to show a difference in onset time between both muscles .\
CONCLUSIONS	In contrast , atracurium is reported to lead to a significantly shorter onset of neuromuscular block in the OO following 2x the ED ( 95 ) .\
CONCLUSIONS	The more rapid recovery of T ( 1 ) to 10 % of its control in all three groups in the OO is due to the relative resistance of this muscle to muscle relaxants .\
\
###18995174\
BACKGROUND	Prior studies suggest that disease management programs may be effective in improving clinical outcomes in patients with heart failure ( HF ) .\
BACKGROUND	However , the use of these programs in settings with limited sources and among diverse population is not know .\
BACKGROUND	Thus the present study was designed to assess the impact of a computer-based home disease management program ( Alere DayLink HF Monitoring System [ HFMS ] ) on the clinical outcomes of Medicare beneficiaries with HF who were elderly , women , and non-white males who received the care from a community-based primary care practitioner .\
RESULTS	The Heart Failure Home Care ( HFHC ) trial was a multicenter , randomized , controlled trial of HFMS versus standard heart failure care ( SC : enhanced patient education , education to clinicians , and follow-up ) .\
RESULTS	The primary study end point was treatment failure , defined as a composite of cardiovascular death or rehospitalization for heart failure within 6 months of enrollment .\
RESULTS	Among patients rehospitalized for HF , length of hospital stay was also considered a primary end point .\
RESULTS	A total of 315 patients were randomized : 160 to HFMS and 155 to SC .\
RESULTS	Although the incidence of the primary outcome was somewhat higher in the SC arm ( 28.8 % versus 21.2 % , P = .15 ) , the difference was not statistically different .\
RESULTS	The length of hospital stay was also similar in both groups .\
CONCLUSIONS	Our study results suggest that enhanced patient education and follow-up is as successful as a sophisticated home monitoring device with an interactive program in patients with HF who are elderly , women and non-Caucasian males and receive the care from a community-based primary care practitioner .\
\
###16879331\
OBJECTIVE	The aim of this in vitro study was to evaluate the microleakage in occlusal surfaces , after preparation with Er : YAG laser and compared to the diamond-bur conventional technique .\
METHODS	Thirty premolars were divided into three groups : I - high-speed handpiece + 37 % phosphoric acid ; II - Er : YAG laser ( 350 mJ , 4 Hz and 112 J/cm ( 2 ) ) + 37 % phosphoric acid ; and III - Er : YAG laser ( 350 mJ , 4 Hz and 112 J/cm ( 2 ) ) + Er : YAG laser ( 80 mJ , 4 Hz , and 25 mJ/cm ( 2 ) ) .\
METHODS	All cavities received the same adhesive system and were restored with flowable composite according to manufacturer 's instructions .\
METHODS	Teeth were submitted to thermal cycling and immersed in 50 % silver nitrate solutions for 8 h in total darkness .\
METHODS	Specimens were sectioned longitudinally in the bucco-lingual direction , in slices of 1 mm thick .\
METHODS	Each slice was immersed into photo developing solution and was photographed , and microleakage was scored from 0 to 7 , by three calibrated examiners .\
RESULTS	A statistically significant difference ( P < 0.0001 ) was observed between Er : YAG laser prepared and etched specimens and those in the other groups .\
CONCLUSIONS	It can be concluded that no significant difference was noted between the two types of enamel preparation when etching was performed .\
CONCLUSIONS	Preparing and treating the enamel surface exclusively by Er : YAG laser resulted in the highest degree of leakage .\
\
###21917326\
BACKGROUND	In patients with heart failure and atrial fibrillation , the AF-CHF ( Atrial Fibrillation and Congestive Heart Failure ) trial did not demonstrate the superiority of rhythm control ( RhyC ) over a rate control ( RaC ) strategy on cardiovascular mortality .\
BACKGROUND	Nevertheless , deleterious hemodynamic effects of atrial fibrillation can lead to further decrease in left ventricular ( LV ) function and progression of symptoms .\
BACKGROUND	This echocardiographic sub-study was designed to compare the effects of the two treatment strategies on LV ejection fraction ( LVEF ) , chamber volumes and dimensions , valvular regurgitation and functional status .\
RESULTS	A total of 59 patients ( 29 RhyC , 30 RaC ) aged 678 years ( 14 % women ) , enrolled in the AF-CHF trial at the Montreal Heart Institute underwent standardized echocardiograms at baseline and at 12 months .\
RESULTS	Mean LVEF at baseline was severely depressed ( RhyC : 27.04.9 % and RaC : 27.67.4 % , p = 0.73 ) , and improved to a similar degree in both groups ( RhyC : +8.010.4 % and RaC : +4.510.6 , both p < 0.05 ; p = 0.19 for RhyC versus RaC ) .\
RESULTS	Other echocardiographic parameters , such as LV end-systolic volume index and degree of mitral and tricuspid regurgitation , remained unchanged .\
RESULTS	New York Heart Association functional class and distance walked in 6 min improved significantly in both groups ( RhyC : +48.978.7 m and RaC : +47.296.7 m , both p0 .01 ) , with no difference between RhyC and RaC strategies .\
CONCLUSIONS	Improvements in LVEF and functional status are observed after 12 months in patients with heart failure and atrial fibrillation , regardless of whether rate or rhythm control strategies are used .\
\
###18694678\
BACKGROUND	New topical treatments in scalp psoriasis are needed because many current topical treatments are disliked by patients and associated with poor compliance .\
OBJECTIVE	To compare the efficacy and safety of once-daily , two-compound scalp formulation containing calcipotriene plus betamethasone dipropionate with the individual components in the same vehicle and the vehicle alone .\
METHODS	In this 8-week , multicenter , randomized , double-blind study , patients with scalp psoriasis were randomized to treatment with the two-compound scalp formulation ( calcipotriene 50 microg/g plus betamethasone 0.5 mg/g , as dipropionate ) ( n = 541 ) , betamethasone 0.5 mg/g ( as dipropionate ) in the same vehicle ( n = 556 ) , calcipotriene 50 microg/g in the same vehicle ( n = 272 ) , or vehicle alone ( n = 136 ) .\
RESULTS	More patients achieved `` absent '' or `` very mild '' disease at week 8 with the two-compound scalp formulation ( 71.2 % ) compared with betamethasone dipropionate in the same vehicle ( 64.0 % , p = .011 ) , calcipotriene in the same vehicle ( 36.8 % , p < .0001 ) , or the vehicle ( 22.8 % , p < .0001 ) .\
CONCLUSIONS	Efficacy of the active comparators in the study has not been established in relation to calcipotriene and betamethasone formulations available for clinical use .\
CONCLUSIONS	Calcipotriene plus betamethasone dipropionate scalp formulation was more effective than either of the individual components or the vehicle alone .\
\
###23359390\
BACKGROUND	Women are underrepresented in clinical research , and few data are available from randomized head-to-head comparisons of second-generation drug-eluting stents ( DES ) in female patients .\
BACKGROUND	Aim of this study was to assess safety and efficacy of two second-generation DES in women .\
BACKGROUND	In TWENTE-a prospective , randomized , comparative DES trial - `` real-world '' patients were stratified for gender before randomization for Resolute or Xience V stents .\
METHODS	Target vessel failure ( TVF ; cardiac death , target vessel-related myocardial infarction , and clinically indicated target vessel revascularization ) after 1 year was the predefined endpoint .\
RESULTS	Among 1,391 patients , 382 ( 27.5 % ) women were randomized to Resolute ( n = 192 ) and Xience V ( n = 190 ) .\
RESULTS	Baseline and procedural characteristics were similar for females in both study arms , except for smaller vessel and stent diameters in Resolute-treated lesions .\
RESULTS	After 1 year , TVF ( 8.9 vs. 8.4 % ; adjusted odds ratio [ OR ] : 0.95 , 95 % confidence interval [ CI ] : 0.41-2 .20 , P = 0.91 ) and a patient-oriented composite endpoint ( 13.0 vs. 12.1 % , P = 0.79 ) did not differ significantly between women in both arms .\
RESULTS	Women were older than men ( P < 0.01 ) and had more often diabetes mellitus ( 26.4 vs. 19.8 % , P = 0.01 ) and hypertension ( 63.6 vs. 52.5 % , P < 0.01 ) , but there was no significant gender difference in TVF ( adjusted OR : 1.18 , 95 % CI : 0.73-1 .92 , P = 0.50 ) .\
CONCLUSIONS	This gender-stratified TWENTE trial analysis resulted in no significant difference in safety and efficacy outcomes between Resolute - and Xience V-treated females .\
\
###19839993\
OBJECTIVE	Asenapine is approved for bipolar disorder and schizophrenia .\
OBJECTIVE	This was a 3-week , randomized , double-blind , placebo-controlled trial of asenapine for treating acute bipolar mania .\
METHODS	After a single-blind placebo run-in period , adults ( n = 488 ) experiencing manic or mixed episodes were randomized to flexible-dose sublingual asenapine ( 10 mg BID on day 1 ; 5 or 10 mg BID thereafter ; n = 194 ) , placebo ( n = 104 ) , or oral olanzapine ( 15 mg BID on day 1 ; 5-20 mg QD thereafter ; n = 191 ) .\
METHODS	Primary efficacy , change in Young Mania Rating Scale ( YMRS ) total score from baseline to day 21 , was assessed using analysis of covariance with last observation carried forward [ ( LOCF ) ; primary analysis ] .\
METHODS	A mixed model for repeated measures [ ( MMRM ) ; prespecified secondary analysis ] was also used to assess efficacy .\
METHODS	Tolerability and safety assessments included adverse events , physical examinations , extrapyramidal symptom ratings , and laboratory values .\
RESULTS	Mean daily dosages were asenapine 18.2 mg and olanzapine 15.8 mg .\
RESULTS	Significantly greater least squares ( LS ) mean + / - SE changes in YMRS scores were observed on day 2 with asenapine ( -3.0 + / - 0.4 ) and olanzapine ( -3.4 + / - 0.4 ) versus placebo ( -1.5 + / - 0.5 , both p < 0.01 ) and were maintained until day 21 ( -10.8 + / - 0.8 with asenapine , -12.6 + / - 0.8 with olanzapine ; both p < or = 0.0001 versus placebo , -5.5 + / - 1.1 ) with LOCF .\
RESULTS	The results of MMRM analyses were consistent with those of LOCF .\
RESULTS	Asenapine had a modest impact on weight and metabolic measures .\
CONCLUSIONS	These results indicate that asenapine is rapidly acting , efficacious , and well tolerated for patients with bipolar I disorder experiencing an acute manic episode .\
\
###20079208\
OBJECTIVE	To observe the long-term effect of short interim high-dose dexamethasone ( HD-DXM ) in previously untreated patients affected by idiopathic thrombocytopenic purpura ( ITP ) and investigate the action of maintenance treatment .\
METHODS	40 mg/d of dexamethasone was given in a 4-day pulse every 14 days for 3 cycles to 45 patients with ITP .\
METHODS	Among them , 22 cases were given routinely dexamethasone of 0.035 mg x kg ( -1 ) x d ( -1 ) for maintenance treatment between courses of high-dose dexamethasone ( HD-DXM + RM group ) and 23 cases were given dexamethasone of 0.035 mg x kg ( -1 ) x d ( -1 ) only when the platelet count was lower than 20 x 10 ( 9 ) / L ( HD-DXM + SM group ) .\
METHODS	As a control group , another 22 cases were given routine dosage of prednisone ( control group ) .\
RESULTS	( 1 ) At the end of the third cycle , the effective rate in the HD-DXM + RM group was 81.8 % ( 18/22 ) , which was higher than 65.2 % ( 15/23 ) of the HD-DXM + SM group and 63.6 % ( 14/22 ) of the control group .\
RESULTS	( 2 ) Among the HD-DXM group patients , the effective rate at the end of the third cycle was higher than that at the end of first and second cycles .\
RESULTS	( 3 ) The effective rate of HD-DXM + RM group was higher than that of HD-DXM + SM group .\
RESULTS	( 4 ) At the time of 1 , 2 , 3 , and 4 months after the end of the last cycle of HD-DXM , the relapse rates in HD-DXM + RM group were 16.7 % , 16.7 % , 27.8 % and 33.3 % respectively , which were lower than that of HD-DXM + SM group and control group respectively .\
CONCLUSIONS	A schedule of 3 cycles of HD-DXM pulses with an interval of 2 weeks between cycles is an effective method for previously untreated ITP patients and maintenance treatment with small-dose dexamethasone between high-dose dexamethasone contributes to improve the long-term curative effect .\
\
###24991815\
OBJECTIVE	We investigated the association of HIV infection and highly active antiretroviral therapy ( HAART ) with sleep disordered breathing ( SDB ) , fatigue , and sleepiness .\
METHODS	HIV-uninfected men ( HIV - ; n = 60 ) , HIV-infected men using HAART ( HIV + / HAART + ; n = 58 ) , and HIV-infected men not using HAART ( HIV + / HAART - ; n = 41 ) recruited from two sites of the Multicenter AIDS cohort study ( MACS ) underwent a nocturnal sleep study , anthropometric assessment , and questionnaires for fatigue and the Epworth Sleepiness Scale .\
METHODS	The prevalence of SDB in HIV - men was compared to that in men matched from the Sleep Heart Health Study ( SHHS ) .\
RESULTS	The prevalence of SDB was unexpectedly high in all groups : 86.7 % for HIV - , 70.7 % for HIV + / HAART + , and 73.2 % for HIV + / HAART - , despite lower body-mass indices ( BMI ) in HIV + groups .\
RESULTS	The higher prevalence in the HIV - men was significant in univariate analyses but not after adjustment for BMI and other variables .\
RESULTS	SDB was significantly more common in HIV - men in this study than those in SHHS , and was common in participants with BMIs < 25 kg/m2 .\
RESULTS	HIV + men reported fatigue more frequently than HIV - men ( 25.5 % vs. 6.7 % ; p = 0.003 ) , but self-reported sleepiness did not differ among the three groups .\
RESULTS	Sleepiness , but not fatigue , was significantly associated with SDB .\
CONCLUSIONS	SDB was highly prevalent in HIV - and HIV + men , despite a normal or slightly elevated BMI .\
CONCLUSIONS	The high rate of SDB in men who have sex with men deserves further investigation .\
CONCLUSIONS	Sleepiness , but not fatigue , was related to the presence of SDB .\
CONCLUSIONS	Clinicians caring for HIV-infected patients should distinguish between fatigue and sleepiness when considering those at risk for SDB , especially in non-obese men .\
\
###16422446\
BACKGROUND	Countermeasures ( e.g. , drugs , training , etc. ) designed to combat the problem of space motion sickness ( SMS ) have had only limited successes .\
BACKGROUND	A possible solution for SMS and terrestrial motion sickness may rest in preventing retinal slip via stroboscopic vision .\
METHODS	There were 32 subjects who participated in a study to investigate the effect of stroboscopic illumination on motion sickness using either a strobe light or liquid crystal display ( LCD ) shutter glasses .\
METHODS	There were 19 subjects who read text and made + / - 20 degrees head movements in the horizontal plane ( yaw ) at 0.2 Hz while wearing left-right reversing prisms and exposed to 4-Hz stroboscopic or normal room illumination ( control condition ) .\
METHODS	Motion sickness was scored using the Miller and Graybiel scale and subjective self-ratings .\
METHODS	In a crossover design , testing was repeated using stroboscopic LCD shutter glasses with an additional 13 subjects and 6 subjects from the first condition .\
RESULTS	During the experiment with a strobe light , motion sickness scores were significantly lower than in the control condition ( chi 0.32 strobe vs. chi 3.79 light = p < 0.003 ) .\
RESULTS	Results with the LCD shutter glasses corresponded with those when the environment was strobed in an otherwise dark room ( chi 1.0 glasses vs. chi 4.1 light = p < 0.001 ) .\
CONCLUSIONS	Stroboscopic illumination reduced the severity of motion sickness symptoms , and shutter glasses with a flash frequency of 4 Hz are as effective as a strobe light .\
CONCLUSIONS	Stroboscopic illumination appears to be an effective countermeasure where retinal slip is a significant factor in eliciting motion sickness due to either self - or surround-motion .\
\
###23660846\
OBJECTIVE	Two randomized trials suggested that transcranial laser therapy ( TLT ) may benefit patients with acute ischemic stroke , although efficacy has not been confirmed .\
OBJECTIVE	Supportive proof of concept could be demonstrated if TLT reduces the volume of cortical infarction .\
METHODS	The NeuroThera Efficacy and Safety Trial-2 ( NEST-2 ) was a randomized trial of TLT versus sham in patients with acute ischemic stroke treated within 24 hours of onset .\
METHODS	Infarct volumes were measured quantitatively and semiquantitatively on all protocol-required computed tomography ( or MRI , if clinically indicated ) scans performed on day 5 ( 2 ) .\
METHODS	Two approaches assessed treatment effects on cortex : ( 1 ) indirectly , by analyzing total infarct volume among patients with clinical presentations suggesting cortical involvement ; and ( 2 ) directly , by assessing the cortical Alberta Stroke Program Early CT Score ( cASPECTS ) components ( M1-M6 , anterior , posterior ) on a 0 - to 8-point modified scale .\
RESULTS	A total of 640 subjects had scans ( 576 computed tomography , 64 MRI ) on day 5 .\
RESULTS	The reliability of ASPECTS ( intraclass correlation coefficient = 0.85 ) and cASPECTS ( intraclass correlation coefficient = 0.82 ) was excellent , and total ASPECTS was correlated with total infarct volume ( r = 0.71 ) .\
RESULTS	In the overall study population , there was no impact of TLT on total infarct volume ( P = 0.30 ) , total ASPECTS ( P = 0.85 ) , or cASPECTS ( P = 0.89 ) .\
RESULTS	Similarly , no effect was seen in any of the following prespecified subgroups selected to indicate cortical involvement : baseline National Institutes of Health Stroke Scale score > 10 , Oxfordshire Total Anterior Circulation Syndrome , subjects with aphasia or extinction at baseline , or subjects with radiographic involvement of cortex .\
CONCLUSIONS	TLT was not associated with a reduction in overall or cortical infarct volume as measured on computed tomography in the subacute phase .\
\
###15127991\
BACKGROUND	The survival rate of oral implants in soft-quality bone has been demonstrated to be inferior to that of implants inserted in good-quality bone .\
BACKGROUND	A possible way to increase the survival rate in soft-quality bone may be to use a tapered implant .\
BACKGROUND	Such an implant has been developed and manufactured by Nobel Biocare AB , Gothenburg , Sweden .\
BACKGROUND	So far , there have been only a few publications regarding this implant .\
OBJECTIVE	The aim of the study was to compare the outcome of using the tapered Brnemark System Mark IV fixture with the outcome of using earlier Brnemark fixtures in a controlled prospective study .\
METHODS	The study was performed as a multicenter study including seven specialist centers .\
METHODS	The material consisted of 40 patients in need of implant-supported bridges in the maxilla .\
METHODS	Twenty-five patients belonged to the test group , in which the tapered Mark IV implants were inserted , and 15 patients belonged to the control group , in which Brnemark Standard or Mark II implants were used .\
METHODS	The patients were allocated to the test group or the control group according to randomization schedules .\
METHODS	The implants were inserted according to the guidelines for Brnemark implants .\
METHODS	A two-stage surgical protocol was used , and abutment connection was made 6 months after fixture insertion .\
METHODS	The test group comprised 97 Mark IV implants , and the control group made up 92 implants .\
METHODS	The prosthetic procedure followed the guidelines for Brnemark implants , and all patients were provided with full fixed maxillary bridges .\
METHODS	The patients were followed up with clinical and radiographic records for 1 year after loading .\
RESULTS	The survival rate was 96.9 % for the Mark IV implants and 98.9 % for the control implants .\
RESULTS	There was no significant difference between the two groups .\
RESULTS	There was a mean marginal bone loss of 0.2 mm during the observation period , and there was no difference between test implants and control implants .\
CONCLUSIONS	With regard to survival rate and marginal bone level changes , no differences could be demonstrated between the Mark IV tapered implant and the Brnemark implants used earlier .\
CONCLUSIONS	However , compared with earlier results of Brnemark implants in soft-quality bone , the Mark IV implant demonstrated an improved survival rate .\
\
###24788589\
BACKGROUND	Antenatal depression and anxiety are associated with adverse obstetric and mental health outcomes , yet practicable nonpharmacological therapies , particularly for the latter , are lacking .\
BACKGROUND	Yoga incorporates relaxation and breathing techniques with postures that can be customized for pregnant women .\
BACKGROUND	This study tested the efficacy of yoga as an intervention for reducing maternal anxiety during pregnancy .\
METHODS	Fifty-nine primiparous , low-risk pregnant women completed questionnaires assessing state ( State Trait Anxiety Inventory ; STAI-State ) , trait ( STAI-Trait ) , and pregnancy-specific anxiety ( Wijma Delivery Expectancy Questionnaire ; WDEQ ) and depression ( Edinburgh Postnatal Depression Scale ; EPDS ) before randomization ( baseline ) to either an 8-week course of antenatal yoga or treatment-as-usual ( TAU ) ; both groups repeated the questionnaires at follow-up .\
METHODS	The yoga group also completed pre - and postsession state anxiety and stress hormone assessments at both the first and last session of the 8-week course .\
RESULTS	A single session of yoga reduced both subjective and physiological measures of state anxiety ( STAI-S and cortisol ) ; and this class-induced reduction in anxiety remained at the final session of the intervention .\
RESULTS	Multiple linear regression analyses identified allocation to yoga as predictive of greater reduction in WDEQ scores ( B = -9.59 ; BCa 95 % CI = -18.25 to -0.43 ; P = .014 ; d = -0.57 ) , while allocation to TAU was predictive of significantly increased elevation in EPDS scores ( B = -3.06 ; BCa 95 % CI = -5.9 to -0.17 ; P = .042 ; d = -0.5 ) .\
RESULTS	No significant differences were observed in state or trait anxiety scores between baseline and follow-up .\
CONCLUSIONS	Antenatal yoga seems to be useful for reducing women 's anxieties toward childbirth and preventing increases in depressive symptomatology .\
\
###18926940\
BACKGROUND	Dietary acid charge enhances bone loss .\
BACKGROUND	Bicarbonate or alkali diet decreases bone resorption in humans .\
BACKGROUND	We compared the effect of an alkaline mineral water , rich in bicarbonate , with that of an acid one , rich in calcium only , on bone markers , in young women with a normal calcium intake .\
METHODS	This study compared water A ( per litre : 520 mg Ca , 291 mg HCO ( 3 ) ( - ) , 1160 mg SO ( 4 ) ( - ) , Potential Renal Acid load ( PRAL ) +9.2 mEq ) with water B ( per litre : 547 mg Ca , 2172 mg HCO ( 3 ) ( - ) , 9 mg SO ( 4 ) ( - ) , PRAL -11.2 mEq ) .\
METHODS	30 female dieticians aged 26.3 yrs ( SD 7.3 ) were randomized into two groups , followed an identical weighed , balanced diet ( 965 mg Ca ) and drank 1.5 l/d of the assigned water .\
METHODS	Changes in blood and urine electrolytes , C-telopeptides ( CTX ) , urinary pH and bicarbonate , and serum PTH were measured after 2 and 4 weeks .\
RESULTS	The two groups were not different at baseline , and showed a similar increase in urinary calcium excretion .\
RESULTS	Urinary pH and bicarbonate excretion increased with water B , but not with water A. PTH ( p = 0.022 ) and S-CTX ( p = 0.023 ) decreased with water B but not with water A.\
CONCLUSIONS	In calcium sufficiency , the acid calcium-rich water had no effect on bone resorption , while the alkaline water rich in bicarbonate led to a significant decrease of PTH and of S-CTX .\
\
###15542294\
OBJECTIVE	This study was conducted to assess whether coronary stenting produces better results compared with balloon angioplasty in patients with acute myocardial infarction ( AMI ) after failed thrombolysis .\
BACKGROUND	Little evidence exists on the value of rescue mechanical reperfusion after failed thrombolysis .\
METHODS	This open-label , randomized study enrolled 181 patients with AMI referred for failed thrombolysis performed within the previous 24 h.\
METHODS	The patients had to have a Thrombolysis In Myocardial Infarction ( TIMI ) flow grade of < or = 2 in coronary angiography .\
METHODS	Patients were randomly assigned to coronary stenting ( 90 patients ) or coronary balloon angioplasty ( 91 patients ) .\
METHODS	Salvage index ( proportion of initial perfusion defect salvaged by rescue intervention ) , which was obtained by paired scintigraphic studies performed 7 to 10 days apart , was the primary end point of the trial .\
METHODS	One-year clinical follow-up was assessed .\
RESULTS	Myocardial salvage index ( median [ 25th , 75th percentiles ] ) was significantly greater in the stent group than in the angioplasty group ( 0.35 [ 0.24 , 0.56 ] vs. 0.25 [ 0.04 , 0.43 ] ; p = 0.005 ) .\
RESULTS	Major bleeding occurred in four patients ( 4 % ) in the stent group and four patients ( 4 % ) in the angioplasty group .\
RESULTS	One-year mortality was 8 % ( 7 patients ) in the stent group versus 12 % ( 11 patients ) in the angioplasty group ( relative risk , 0.6 ; 95 % confidence interval 0.2 to 1.6 ; p = 0.35 ) .\
CONCLUSIONS	Patients with AMI and failed thrombolysis benefit from rescue mechanical reperfusion in terms of myocardial salvage .\
CONCLUSIONS	Coronary stenting is associated with a greater myocardial salvage in this setting compared with coronary balloon angioplasty .\
\
###22672794\
BACKGROUND	Total knee arthroplasty ( TKA ) is often associated with a severe local inflammatory reaction which , unless controlled , leads to persistent pain up to one year after surgery .\
BACKGROUND	Standard and accelerated rehabilitation protocols are currently being implemented after TKA , but no consensus exists regarding the long-term effects .\
BACKGROUND	Biophysical stimulation with pulsed electromagnetic fields ( PEMFs ) has been demonstrated to exert an anti-inflammatory effect , to promote early functional recovery and to maintain a positive long-term effect in patients undergoing joint arthroscopy .\
BACKGROUND	The aim of this study was to evaluate whether PEMFs can be used to limit the pain and enhance patient recovery after TKA .\
METHODS	A prospective , randomized , controlled study in 30 patients undergoing TKA was conducted .\
METHODS	Patients were randomized into experimental PEMFs or a control group .\
METHODS	Patients in the experimental group were instructed to use I-ONE stimulator 4hours/day for 60days .\
METHODS	Postoperatively , all patients received the same rehabilitation program .\
METHODS	Treatment outcome was assessed using the Knee Society Score , SF-36 Health-Survey and VAS .\
METHODS	Patients were evaluated pre-operatively and one , two , six and 12 months after TKA .\
METHODS	Joint swelling and Non Steroidal Anti Inflammatory Drug ( NSAID ) consumption were recorded .\
METHODS	Comparisons between the two groups were carried out using a two-tail heteroschedastic Student 's t-test .\
METHODS	Analysis of variance for each individual subject during the study was performed using ANOVA for multiple comparisons , applied on each group , and a Dunnet post hoc test .\
METHODS	A p value < 0.05 was considered statistically significant .\
RESULTS	Pre-operatively , no differences were observed between groups in terms of age , sex , weight , height , Knee-Score , VAS , SF-36 and joint swelling , with the exception of the Functional Score .\
RESULTS	The Knee-Score , SF-36 and VAS demonstrated significantly positive outcomes in the I-ONE stimulated group compared with the controls at follow-ups .\
RESULTS	In the I-ONE group , NSAID use was reduced and joint swelling resolution was more rapid than in controls .\
RESULTS	The effect of I-ONE therapy was maintained after use of the device was discontinued .\
CONCLUSIONS	The results of the study show early functional recovery in the I-ONE group .\
CONCLUSIONS	I-ONE therapy should be considered after TKA to prevent the inflammatory reaction elicited by surgery , for pain relief and to speed functional recovery .\
\
###10958124\
OBJECTIVE	There is a commonly held belief among health care providers that patients respond better to parenteral nonsteroidal anti-inflammatory drugs ( NSAIDs ) than to oral forms by virtue of the patients ' belief that getting an injection means they are receiving `` stronger '' medicine .\
OBJECTIVE	To the authors ' knowledge , this effect has never been adequately documented in the literature .\
OBJECTIVE	The objective of this study was to compare the effects of a placebo analgesic injection vs placebo oral analgesia on patients with acute musculoskeletal pain .\
METHODS	A convenience sample of emergency department ( ED ) patients with acute musculoskeletal pain secondary to trauma were enrolled .\
METHODS	Patients received 225 mL of orange-flavored drink containing 800 mg of ibuprofen .\
METHODS	Patients then received either a physiologically inactive starch tablet resembling ibuprofen 800 mg in taste and appearance or a physiologically inactive saline intramuscular ( IM ) injection resembling ketorolac 60 mg .\
METHODS	Both patients and research nurses were blinded to the addition of ibuprofen to the drink and the inactive nature of subsequent medication .\
METHODS	Pain was evaluated at time 0 and at 30 , 60 , 90 , and 120 minutes on a 10-mm visual analog scale ( VAS ) .\
RESULTS	Sixty-four patients completed the study protocol .\
RESULTS	The VAS scores between groups did not differ significantly at baseline or at each subsequent interval ( p = 0.86 ) .\
CONCLUSIONS	These results contradict the belief that parenteral medications confer a selective placebo effect stemming from patients ' beliefs regarding route of administration and efficacy .\
CONCLUSIONS	Therefore , the routine use of IM administration of NSAIDs for suspected enhanced analgesia appears unwarranted .\
\
###19591674\
BACKGROUND	Osteochondral talar defects usually affect athletic patients .\
BACKGROUND	The primary surgical treatment consists of arthroscopic debridement and microfracturing .\
BACKGROUND	Although this is mostly successful , early sport resumption is difficult to achieve , and it can take up to one year to obtain clinical improvement .\
BACKGROUND	Pulsed electromagnetic fields ( PEMFs ) may be effective for talar defects after arthroscopic treatment by promoting tissue healing , suppressing inflammation , and relieving pain .\
BACKGROUND	We hypothesize that PEMF-treatment compared to sham-treatment after arthroscopy will lead to earlier resumption of sports , and aim at 25 % increase in patients that resume sports .\
METHODS	A prospective , double-blind , randomized , placebo-controlled trial ( RCT ) will be conducted in five centers throughout the Netherlands and Belgium .\
METHODS	68 patients will be randomized to either active PEMF-treatment or sham-treatment for 60 days , four hours daily .\
METHODS	They will be followed-up for one year .\
METHODS	The combined primary outcome measures are ( a ) the percentage of patients that resume and maintain sports , and ( b ) the time to resumption of sports , defined by the Ankle Activity Score .\
METHODS	Secondary outcome measures include resumption of work , subjective and objective scoring systems ( American Orthopaedic Foot and Ankle Society -- Ankle-Hindfoot Scale , Foot Ankle Outcome Score , Numeric Rating Scales of pain and satisfaction , EuroQol-5D ) , and computed tomography .\
METHODS	Time to resumption of sports will be analyzed using Kaplan-Meier curves and log-rank tests .\
CONCLUSIONS	This trial will provide level-1 evidence on the effectiveness of PEMFs in the management of osteochondral ankle lesions after arthroscopy .\
BACKGROUND	Netherlands Trial Register ( NTR1636 ) .\
\
###9597214\
OBJECTIVE	To compare the incidence of complications during placement of Arrow ( FlexTip Plus ) and Concord/Portex epidural catheters in parturients receiving continuous epidural analgesia .\
METHODS	Two hundred parturients requesting continuous epidural analgesia were prospectively and randomly assigned to receive either the Arrow ( FlexTip Plus ) or the Portex epidural catheter .\
METHODS	The incidences of paresthesiae , inadvertent venous cannulation and inability to thread the catheter into the epidural space were recorded .\
RESULTS	A total of 222 attempts at epidural placement occurred in the parturients enrolled .\
RESULTS	The Arrow catheter displayed a lower incidence of paresthesiae ( 3/112 vs 39/110 , P < 0.0001 ) and venous cannulation ( 0/112 vs 11/110 , P = 0.0007 ) than did the Portex catheter .\
RESULTS	The Portex catheter demonstrated a tendency towards increased inability to be advanced into the epidural space ( 5/110 vs 0/112 , P = 0.057 ) in comparison to the Arrow catheter .\
RESULTS	When a Portex catheter would not advance into the epidural space ( n = 5 ) , an Arrow catheter was threaded successfully in all five cases without the need to reposition the Tuohy needle .\
CONCLUSIONS	Compared with a less flexible catheter , the Arrow decreases the incidence of transient paresthesiae and inadvertent venous cannulation , while improving the ability to thread the catheter into the epidural space .\
CONCLUSIONS	Intravascular injection , transarachnoid migration , and the rare occurrence of epidural haematoma may be further reduced with the use of flexible , soft-tip catheters .\
\
###21208594\
OBJECTIVE	A limited number of randomized clinical trials show that efficacious pharmacologic treatments exist for comorbid major depressive disorder ( MDD ) and generalized anxiety disorder ( GAD ) .\
OBJECTIVE	The aims of this effectiveness study were to describe the impact of a depression care management intervention on the persistence of comorbid GAD symptoms in a sample of primary care patients with MDD and to identify risk factors for persistent GAD .\
METHODS	Data were collected from April 2003 to September 2005 for the Telemedicine-Enhanced Antidepressant Management ( TEAM ) study , a multisite , randomized effectiveness trial targeting US Department of Veterans Affairs ( VA ) primary care patients with depression .\
METHODS	Veterans aged 26.59-88 .36 years received either the TEAM intervention or usual care in small VA community-based outpatient clinics .\
METHODS	The TEAM care management intervention focused on optimizing antidepressant therapy through patient education and activation , symptom monitoring , adherence promotion , and side-effect management .\
METHODS	Veterans who screened positive for MDD using the Patient Health Questionnaire-9 ( based on DSM-IV criteria ) and who met the Mini-International Neuropsychiatric Interview criteria ( maintaining consistency with DSM-IV-TR ) for comorbid GAD at baseline were selected for the present study ( N = 168 ) .\
METHODS	The primary outcome was persistence of GAD at 6 months and 12 months .\
METHODS	All predictors available in the TEAM study data that were described in the literature to be associated with influencing GAD outcomes were examined .\
RESULTS	Persistence of depression was the strongest predictor of persistence of comorbid GAD at both 6 months ( OR = 5.75 ; 95 % CI , 2.38-13 .86 ; P < .05 ) and 12 months ( OR = 15.56 ; 95 % CI , 6.10-39 .68 ; P < .05 ) .\
RESULTS	Although the TEAM intervention significantly reduced depression symptom severity , it was not significantly associated with GAD persistence .\
RESULTS	Insomnia was a significant protective factor for persistence of GAD at 6 months ( OR = 0.66 ; 95 % CI , 0.44-0 .99 ; P < .05 ) .\
CONCLUSIONS	Early screening for presence of comorbid GAD among those with MDD may be valuable both for further research and for enhancing clinical management of GAD and MDD comorbidity .\
\
###23896681\
BACKGROUND	HIV infection leads to activation of coagulation , which may increase the risk for atherosclerosis and venous thromboembolic disease .\
BACKGROUND	We hypothesized that HIV replication increases coagulation potentially through alterations in extrinsic pathway factors .\
RESULTS	Extrinsic pathway factors were measured among a subset of HIV participants from the Strategies for Management of Anti-Retroviral Therapy ( SMART ) trial .\
RESULTS	Thrombin generation was estimated using validated computational modeling based on factor composition .\
RESULTS	We characterized the effect of antiretroviral therapy ( ART ) treatment versus the untreated state ( HIV replication ) via 3 separate analyses : ( 1 ) a cross-sectional comparison of those on and off ART ( n = 717 ) ; ( 2 ) a randomized comparison of deferring versus starting ART ( n = 217 ) ; and ( 3 ) a randomized comparison of stopping versus continuing ART ( n = 500 ) .\
RESULTS	Compared with viral suppression , HIV replication consistently showed short-term increases in some procoagulants ( eg , 15 % to 23 % higher FVIII ; P < 0.001 ) and decreases in key anticoagulants ( eg , 5 % to 9 % lower antithrombin [ AT ] and 6 % to 10 % lower protein C ; P < 0.01 ) .\
RESULTS	The net effect of HIV replication was to increase coagulation potential ( eg , 24 % to 48 % greater thrombin generation from computational models ; P < 0.01 for all ) .\
RESULTS	The pattern of changes from HIV replication was reversed with ART treatment and consistent across all 3 independent comparisons .\
CONCLUSIONS	HIV replication leads to complex changes in extrinsic pathway factors , with the net effect of increasing coagulation potential to a degree that may be clinically relevant .\
CONCLUSIONS	The key influence of changes in FVIII and AT suggests that HIV-related coagulation abnormalities may involve changes in hepatocyte function in the context of systemic inflammation .\
\
###24445685\
OBJECTIVE	The aim of this study was to evaluate the effectiveness of oral n-acetyl cysteine , as a potential nephroprotective agent , in preventing and/or attenuating amphotericin B-induced electrolytes imbalances .\
METHODS	During a one year period , patients were to receive conventional amphotericin b for any indication for at least one week and were randomly allocated to receive either placebo or 600 mg oral n-acetyl cysteine twice daily during the treatment course of amphotericin b. Demographic and clinical data of the study population were gathered .\
METHODS	Different aspects of amphotericin b nephrotoxicity including decrease of glomerular filtration rate , hypokalemia , hypomagnesemia , renal magnesium and potassium wasting were assessed .\
METHODS	Each patient was monitored for any adverse reaction to n-acetyl cysteine .\
METHODS	Sixteen and 14 patients in the n-acetyl cysteine and placebo groups completed the study , 3incidences of hypokalemia ( 75 % versus 70 % ; P = 0.724 ) and hypomagnesemia ( 30 % versus 20 % ; P = 0.468 ) did not differ significantly between placebo and NAC groups , respectively .\
METHODS	Although the rate of AmB nephrotoxicity was higher in the placebo than in the NAC group ( 60 % versus 40 % ) , this difference was not statistically significant ( P = 0.209 ) even after adjusting for probable associated factors of amphotericin b nephrotoxicity ( P = 0.206 ) .\
METHODS	The incidence as well as time of onset of electrolyte abnormalities also did not differ significantly between placebo and n-acetyl cysteine groups .\
METHODS	About 44 % of n-acetyl cysteine recipients experienced new onset nausea and a mild unpleasant taste during the study .\
CONCLUSIONS	Oral n-acetyl cysteine during the amphotericin B treatment course was not significantly effective in preventing or mitigating different features of its nephrotoxicity including decrease of glomerular filtration rate , hypokalemia , hypomagnesemia , and renal potassium as well as magnesium wasting .\
\
###17635247\
BACKGROUND	There are limited numbers of studies focused on the using of platelet-rich plasma ( PRP ) combined with different types of bone substitutes in intra-bony defects .\
OBJECTIVE	The purpose of this study was to evaluate the effect of bioactive glass graft material ( BG ) with and without PRP on the clinical healing of intra-bony defects .\
METHODS	Twenty-nine intra-bony defects were randomly treated with either PRP/BG or BG alone .\
METHODS	Clinical parameters were recorded at baseline and repeated 9 months after surgery and surgical reentries were also performed .\
RESULTS	The results showed that both treatment modalities were effective .\
RESULTS	Pocket depth reduction of 3.60 + / - 0.51 mm , clinical attachment gain of 3.3 + / - 1.77 mm and defect fill of 3.47 + / - 0.53 mm were noted in the PRP/BG group , with 3.29 + / - 1.68 , 2.86 + / - 1.56 and 3.36 + / - 0.55 mm improvements , respectively , noted for the BG group .\
RESULTS	None of the differences between the two treatment modalities were statistically significant .\
CONCLUSIONS	It is suggested that both PRP/BG combination and BG alone are effective in the treatment of intra-bony defects .\
CONCLUSIONS	The results also showed that using PRP with BG has no additional benefit in the reduction of pocket depth , clinical attachment gain and defect fill .\
\
###22623016\
BACKGROUND	Tramadol is a prescription analgesic that activates mu opioid and monoamine receptor systems .\
BACKGROUND	Tramadol is thought to have limited abuse potential compared to mu opioid agonists , but laboratory data indicate that it shares some of their pharmacodynamic effects .\
OBJECTIVE	This study evaluated the effect of mu opioid receptor blockade with naltrexone on the pharmacodynamic action of tramadol in humans .\
METHODS	This inpatient , double-blind , randomized , within-subject study examined the effects of oral placebo , tramadol ( 87.5 , 175 , and 350 mg ) , and hydromorphone ( 4 and 16 mg ; positive control ) after 1 h pretreatment with oral naltrexone ( 0 and 50 mg ) .\
METHODS	Ten recreational opioid users completed the study .\
METHODS	Pharmacodynamic effects were measured before and for 7 h after initial drug administration .\
RESULTS	Lower doses of tramadol and hydromorphone were generally placebo-like .\
RESULTS	Hydromorphone ( 16 mg ) produced prototypic mu opioid agonist-like effects that were blocked by naltrexone .\
RESULTS	Tramadol ( 350 mg ) produced miosis and increased ratings of `` Good Effects '' and `` Liking '' but also increased ratings of `` Bad Effects . ''\
RESULTS	Naltrexone reversed tramadol-induced physiological effects and mydriasis emerged , but unlike results with hydromorphone , naltrexone only partially attenuated tramadol 's positive subjective effects and actually enhanced several unpleasant subjective ratings .\
CONCLUSIONS	Naltrexone can be used to disentangle the mixed neuropharmacological actions of tramadol .\
CONCLUSIONS	High-dose tramadol produces a mixed profile of effects .\
CONCLUSIONS	These data suggest that both mu and non-mu opioid actions play a role in tramadol 's subjective profile of action .\
\
###21946291\
BACKGROUND	Falls and fall-related injuries are critical issues for older adults ; evidence indicates that multidimensional interventions that address modifiable risk factors can be successful in reducing falls .\
BACKGROUND	Few evidence-based fall prevention interventions exist due , in part , to complex issues associated with development and implementation .\
BACKGROUND	There is a need for a variety of such programs from which older adults may choose .\
BACKGROUND	We describe steps , outcomes , and issues involved in developing/implementing an evidenced-based fall prevention program in community settings .\
METHODS	The Stay In Balance program ( SIB ) , developed by a team of professionals , local service providers and active older adults , was carried out with total of 135 older adults in several steps : developing objectives and program content , laboratory-based randomized controlled trial ( RCT ) , pilot program in the community , community-based RCT , and implementation at 2 community sites .\
RESULTS	Each step in development provided useful and different insights into needed changes in program content , equipment , support materials , training , and appropriate outcome measures .\
CONCLUSIONS	Development of an evidenced-based fall prevention program requires a long term commitment on the part of all partners , University personnel , local service providers , and older adult participants ; funding is also critical .\
\
###16680253\
OBJECTIVE	To evaluate the preemptive effects of diclofenac sodium , in combination with remifentanil and ketamine .\
METHODS	A prospective , randomized , double blind , placebo-controlled trial was carried out at the Hacettepe University Hospital , Ankara , Turkey from September to December 2004 .\
METHODS	Forty-three , American Society of Anesthesiology physical status group I-II women , aged > 18 years , who would undergo both diagnostic and operative laparoscopic surgery were randomly assigned into 2 groups .\
METHODS	All patients received intraoperative 0.1 microg x kg ( -1 ) min ( -1 ) remifentanil infusion .\
METHODS	Diclofenac ( 1 mg x kg ( -1 ) intramuscular ) was administered , 20 minutes before the operation .\
METHODS	Ketamine ( 0.8 mg x kg ( - ) 1 intravenously ) was administered 5 minutes before the skin incision and at completion of skin closure .\
METHODS	We divided the patients into 2 groups ; Group I ( diclofenac + remifentanil + ketamine ) , Group II ( remifentanil + ketamine ) .\
METHODS	Pain was evaluated postoperatively using the visual analogue scale ( VAS ) while global satisfaction by verbal rating scale ( VRS ) .\
RESULTS	All 43 female patients have a mean + / - SD age of 32.3 + / - 6.5 years , height of 163 + / - 5.3 cm , and weight of 62.9 + / - 9.5 kg .\
RESULTS	The VAS and VRS scores and also time to first analgesic request were not different between the groups .\
RESULTS	In all groups , > 98 % of the patients were satisfied or very satisfied .\
CONCLUSIONS	We have not found any preemptive or additive effect of diclofenac sodium with the concomitant use of ketamine .\
\
###9201012\
BACKGROUND	Cigarette smoking is the greatest cause of preventable mortality in the United States .\
BACKGROUND	Because most smokers would like to quit and most hospitals are smoke free , surgical admissions represent a window of opportunity for tobacco cessation interventions .\
METHODS	A total of 324 patients ( 98 % men ) , aged 25 to 82 years , who were current smokers and who underwent noncardiac surgery were enrolled in a randomized controlled trial at the Veterans Affairs Medical Center , San Francisco , Calif. .\
METHODS	One hundred sixty-eight participants ( 52 % ) received a multicomponent intervention designed to increase self-efficacy and coping skills that included face-to-face in-hospital counseling , viewing a smoking cessation videotape , self-help literature , nicotine replacement therapy , and 3 months of telephone follow-up .\
METHODS	One hundred fifty-six participants ( 48 % ) received self-help literature and brief counseling lasting 10 minutes .\
METHODS	Serum or saliva cotinine levels were measured to confirm self-reported smoking cessation .\
RESULTS	At 12 months of follow-up , the self-reported quit rate was 27 % among the intervention group and 13 % among the comparison group ( relative risk , 2.1 ; 95 % confidence interval , 1.2-3 .5 ; P < .01 ) .\
RESULTS	Based on biochemical confirmation , 15 % of the intervention group , compared with 8 % of the comparison group , quit smoking at 12 months ( relative risk , 2.0 ; 95 % confidence interval , 1.0-3 .9 ; P = .04 ) .\
CONCLUSIONS	A smoking cessation intervention targeted at smokers hospitalized for noncardiac surgery can increase long-term quit rates .\
CONCLUSIONS	Surgical hospitalizations provide an opportunity to reach smokers who want to quit smoking .\
\
###19075276\
OBJECTIVE	To investigate whether retinyl palmitate ( RP ) alone or plus beta-carotene ( BC ) would be as effective and less toxic than low-dose 13-cis retinoic acid ( 13cRA ) in treating oral premalignant lesions ( OPLs ) and reducing the risk of oral cancer .\
METHODS	Initially , patients were randomly assigned to receive low-dose 13cRA or BC plus RP for 3 years ( plus 2 years follow-up ) .\
METHODS	After other randomized trials established an adverse effect of BC on lung cancer incidence/mortality , BC was dropped ( patients randomly assigned to 13cRA or RP alone ) .\
METHODS	The primary end point was OPL clinical response at 3 months .\
RESULTS	We randomly assigned 162 eligible patients .\
RESULTS	The 3-month clinical response rate of the combined BC plus RP and RP alone arm ( 32.5 % ) was not statistically equivalent to that of 13cRA ( 48.1 % ) .\
RESULTS	The clinical response rate of RP alone ( 20.0 % ) was significantly lower than that of BC plus RP ( 42.9 % ; P = .03 ) .\
RESULTS	Similar oral cancer-free survival rates were observed across all arms .\
RESULTS	There was no significant association between 3-month OPL response and subsequent oral cancer development ( P = .11 ) .\
RESULTS	Grades 2 and higher adverse events were more common in the 13cRA than other groups ( P < .0001 ) .\
CONCLUSIONS	This large chemoprevention trial did not establish the equivalence of RP plus BC or RP alone with low-dose 13cRA in reducing the long-term risk of oral cancer .\
CONCLUSIONS	At present , 13cRA , BC plus RP , and RP alone can not be recommended for chemoprevention , and new , better agents are needed in this setting .\
CONCLUSIONS	Our results did not establish short-term OPL response as a surrogate end point for oral cancer-free survival .\
\
###12444837\
BACKGROUND	Physicians report several barriers to the use of oral rehydration therapy ( ORT ) for dehydration in children due to acute gastroenteritis .\
OBJECTIVE	To compare ORT with intravenous therapy for the treatment of moderate dehydration in children with acute gastroenteritis and to determine whether the factors reported as barriers to the use of ORT would be substantiated in practice .\
METHODS	Randomized controlled trial in an urban pediatric emergency department .\
METHODS	Children with moderate dehydration due to acute gastroenteritis were randomly assigned to ORT ( group 1 ) or intravenous therapy ( group 2 ) .\
METHODS	The primary outcome was length of stay in the emergency department .\
METHODS	Secondary outcomes included hospital admission rate , staff time , relapse after discharge from the hospital , and parental satisfaction .\
METHODS	Two days after discharge , parents were surveyed by telephone to assess the relapse and their satisfaction with the visit .\
RESULTS	Eighteen patients were enrolled in group 1 and 16 in group 2 .\
RESULTS	The mean length of stay in group 1 was 225 vs 358 minutes in group 2 ( P < .01 ) .\
RESULTS	Mean staff time was 35.8 minutes in group 1 compared with 65 minutes in group 2 ( P = .03 ) .\
RESULTS	Three patients failed ORT and required intravenous therapy .\
RESULTS	Two patients ( 11 % ) in group 1 vs 4 ( 25 % ) in group 2 required admission to the hospital ( P = .20 ) .\
RESULTS	No patients relapsed after being discharged from the hospital .\
RESULTS	Fourteen parents ( 77 % ) in group 1 compared with 6 ( 37.5 % ) in group 2 reported that they were highly satisfied with all aspects of the visit ( P = .01 ) .\
CONCLUSIONS	Reported barriers to ORT were not supported by our data .\
CONCLUSIONS	Moreover , ORT performed better than intravenous therapy on all measured outcomes .\
\
###16083602\
OBJECTIVE	To verify the role and effect of external vavuloplasty in the treatment of chronic venous insufficiency ( CVI ) of lower extremity .\
METHODS	Thirty patients with CVI of bilateral lower extremities were enrolled to accept surgical management of vein systems .\
METHODS	Both limbs of each patient were randomized into two groups respectively according to the operating style .\
METHODS	One limb was given external vavuloplasty of the superficial femoral vein and surgery of superficial venous system ( group A ) , the another limb was only given the surgery of superficial venous system ( group B ) .\
METHODS	The effect comparison between both limbs of each patient and two groups by color duplex scanning , color doppler velocity profile ( CDVP ) , air plethysmography and CEAP score system one month and 3 years after operation .\
RESULTS	All 60 limbs of 30 cases were CEAP C ( 2 ) - C ( 4 ) with degree III reflux ( Kistner 's method ) in the deep veins confirmed by color duplex scanning and venography .\
RESULTS	In 1 month and 3 years after surgery , all the indexes of the limb in the group A were dramatically improved compared with those of the limbs in the group B.\
RESULTS	The average value of venous reflux degree , reflux volume , and venous filling index ( VFI ) had significant difference between the two groups ( P < 0.001 ) .\
RESULTS	In 3 years after surgery , there was significant difference between the two groups on ejective fraction ( EF ) and residual volume fraction ( RVF ) ( P < 0.05 ) and CEAP clinical score ( P < 0.001 ) .\
CONCLUSIONS	External vavuloplasty of deep vein may reduce the reflux volume of the affected deep vein and improve the valve function , and can result in better outcomes when combined with surgery of the superficial venous system .\
\
###21517964\
OBJECTIVE	Acute otitis media ( AOM ) is a common childhood disease , which often becomes recurrent ( rAOM ) .\
OBJECTIVE	A small reduction in AOM episodes has been noted in unselected child cohorts after vaccination with heptavalent conjugate pneumococcal vaccine ( PCV7 ) .\
OBJECTIVE	The purpose of this study was to investigate how vaccination affects young children at risk of developing rAOM .\
METHODS	Ninety-six children with an AOM onset before 6 months of age , implying a high risk for rAOM , were closely monitored until the age of 2 years .\
METHODS	Forty-six were vaccinated with PCV7 and 50 were not .\
METHODS	All episodes of AOM , emergency visits and ventilation tube insertions were registered .\
RESULTS	A total of 363 AOM episodes were diagnosed .\
RESULTS	The incidence was reduced by 26 % ( p = 0.03 ) , the number of emergency visits because of suspected AOM by 36 % ( p = 0.01 ) and the proportion of children who received ventilation tubes was halved in the vaccine group ( p = 0.02 ) .\
CONCLUSIONS	During the first 2 years of life , PCV7 significantly reduced AOM episodes , emergency visits and ventilation tube insertions in children with rAOM .\
CONCLUSIONS	Pneumococcal vaccine may be a future route to reduce antibiotic use and health care consumption in otitis-prone children .\
\
###24318319\
OBJECTIVE	The purpose of this prospective randomised trial was to assess whether an intramedullary nail is superior to a sliding hip screw in the treatment of multifragmentary intertrochanteric fractures\
METHODS	Eighty patients with a 31-A2 .2 or A2 .3 Arbeitsgemeinschaft fr Osteosynthesefragen/Orthopaedic Trauma Association ( AO/OTA ) intertrochanteric fracture were randomly allocated to fixation with either the Gamma nail or the AMBI sliding hip screw device .\
RESULTS	All patients were followed up at one , three , six and 12months postoperatively , except for nine who died .\
RESULTS	There was no statistical difference in Parker mobility score between groups .\
RESULTS	The Gamma nail group had significantly higher Barthel Index and EuroQol-5D ( EQ-5D ) scores than the AMBI group at 12months .\
RESULTS	At the same time , the EQ-5D score had returned to its pre-operative values in the Gamma nail group but not in the AMBI group .\
RESULTS	There were no differences in mortality , radiation time and hospital stay .\
RESULTS	Duration of the operation , incision length and hip pain occurrence were significantly less in the Gamma nail group .\
CONCLUSIONS	Few failures occur when unstable 31-A2 .2 and A2 .3 AO/OTA fractures are fixed with a sliding hip screw .\
CONCLUSIONS	Nevertheless , an intramedullary nail seems superior in reconstituting patients to their pre-operative state .\
\
###17574730\
OBJECTIVE	To compare OAB symptom outcomes following initial randomised treatment with solifenacin 5 mg or tolterodine ER 4 mg at the 4-week clinic-visit and again at 12 weeks for patients choosing to remain on this treatment dose from 4 weeks .\
METHODS	A prospective , double blind , double-dummy , two-arm , parallel-group , 12-week study ( The STAR study ) was conducted to compare the efficacy and safety of solifenacin 5/10 mg and tolterodine extended release ( ER ) 4 mg in OAB patients .\
RESULTS	At 4 weeks mean improvements in OAB symptoms , including urgency , frequency ( primary variable ) , incontinence and nocturia , were larger in patients randomised to solifenacin 5 mg ; with the difference for incontinence being statistically significant ( mean reduction in incontinence episodes/24 hrs in the solifenacin group of -1.30 vs. -0.90 ( p = 0.0181 ) ; the mean result for solifenacin 5 mg amounted to a 44 % additional improvement . )\
RESULTS	There was an associated significant reduction in pad use ( reduced by -1.21 vs. -0.80 ; p = 0.0089 ) ; the mean result for solifenacin 5 mg amounted to a 51 % additional improvement over that of tolterodine ER 4 mg .\
RESULTS	For patients choosing to remain on these treatments improvements in favour of solifenacin were maintained at study end ( 12-weeks ) .\
RESULTS	Treatments were well tolerated .\
CONCLUSIONS	Within 4 weeks solifenacin 5mg was statistically significantly better than tolterodine ER 4 mg in improving incontinence and reducing incontinence pad use .\
CONCLUSIONS	Differences in efficacy in favour of solifenacin 5 mg were maintained from 4 weeks for the duration of the study for patients choosing to remain on their starting dose .\
\
###15248821\
BACKGROUND	In severe illness , plasma selenium levels are decreased ; a decreased activity of the selenoenzyme 5 ' - deiodinase has been hypothesized to contribute to low tri-iodothyronine ( T3 ) levels in non-thyroidal illness ( NTI ) syndrome in these patients .\
OBJECTIVE	To analyse the influence of selenium substitution on thyroid hormone metabolism in patients with severe sepsis .\
METHODS	A prospective , randomized , controlled study at the medical internal intensive care unit of the University of Munich .\
METHODS	Results are for 41 consecutive patients with severe sepsis with an APACHE II score > 15 .\
METHODS	Patients received either sodium selenite ( 500 microg/day for the first 3 days , reducing to 250 and then 125 microg/day every 3 days ) or a placebo .\
RESULTS	At study entry , APACHE II score and demographics were identical in both groups .\
RESULTS	The mean levels of TSH , free tri-iodithyronine and total T3 , as well as plasma selenium and selenium-dependent peroxidase ( GSH-Px ) activity , were decreased .\
RESULTS	Plasma selenium and GSH-Px activity were normalized on days 3 , 7 and 14 in patients receiving selenium ( n = 21 ) , but remained below normal in the control patients .\
RESULTS	Patients receiving selenium had a better clinical outcome and thyroid hormone levels normalized earlier .\
RESULTS	Thyroid hormone levels increased in patients who showed clinical improvement , independent of selenium levels or selenium substitution .\
CONCLUSIONS	Selenium substitution in patients with NTI improves morbidity , but has no direct effect on the free and total thyroid hormones .\
CONCLUSIONS	In severely ill patients , decreased deiodinase activity due to low plasma selenium levels seems unlikely .\
CONCLUSIONS	After clinical revival , TSH and then the thyroidal hormones normalize independently of selenium substitution .\
\
###22561876\
OBJECTIVE	To assess the efficacy of atomoxetine ( ATX ) and impact of treatment on family functioning in adults with ADHD .\
METHODS	Adults with attention-deficit/hyperactivity disorder ( ADHD ) having both a spouse/partner and child were randomized to placebo ( n = 234 ) or ATX ( n = 268 ) for 24 weeks .\
METHODS	Attention-deficit/hyperactivity disorder measures included the Conners Adult ADHD Rating Scale total ADHD Symptoms score and Clinical Global Impression-ADHD-Severity .\
METHODS	Marital measures included the Dyadic Adjustment Scale and the Family Assessment Measure Dyadic Relationship Scale ( FAM III ) .\
METHODS	Parenting measures included the Parenting Stress Index , Alabama Parenting Questionnaire , and Parenting Sense of Competence Scale ( PSCS ) .\
RESULTS	Improvement was greater with ATX over placebo at 24 weeks on the Conners Adult ADHD Rating Scale ( -16.43 vs -8.65 ; P < 0.001 , repeated measures ) and Clinical Global Impression ( P < 0.001 , last observation carried forward ) .\
RESULTS	Baseline-to-end point changes in marital and parenting measures were significant but not between treatment groups .\
RESULTS	Post hoc analyses showed significant interaction of treatment and impairment for the FAM III Task Accomplishment ( patient ) and Role Performance ( patient and spouse ) items and PSCS efficacy .\
RESULTS	Further stratification by sex or presence of a child with ADHD yielded significant interaction and treatment differences for the FAM III Task Accomplishment and the FAM III and Dyadic Adjustment Scale affective expression items , PSCS total score , Alabama Parenting Questionnaire Corporal Punishment , and Parenting Stress Index attachment items .\
CONCLUSIONS	Atomoxetine demonstrated significant ADHD symptom reduction over 24 weeks .\
CONCLUSIONS	Although both groups demonstrated baseline-to-end point changes on many marital and parenting measure items , there were no treatment differences .\
CONCLUSIONS	Maladaptive behaviors of long-standing ADHD may benefit from both medication and behavioral-psychosocial intervention .\
\
###8946270\
BACKGROUND	Hypertriglyceridaemia ( HTG ) , glucose intolerance , insulin resistance and elevated plasma activity of plasminogen activator inhibitor ( PAI ) -1 are risk factors for ischaemic heart disease .\
BACKGROUND	Because these conditions tend to cluster in the same individuals , the concerted action of gemfibrozil on all these parameters were investigated in a patient group with primary HTG .\
METHODS	Gemfibrozil was given as 600 mg tablets twice a day for 12 months to a group of middle-aged non-diabetic men with moderate HTG .\
METHODS	Patients served as their own controls , because the treatment period was preceded by a single-blinded 2-month placebo phase .\
METHODS	Gradient gel electrophoresis subfractionation of HDL was performed and glucose tolerance was defined according to World Health Organization criteria .\
METHODS	The insulin sensitivity was assessed by the insulin-modified minimal model method .\
METHODS	Plasma PAI-1 was assayed as activity .\
RESULTS	Serum triglyceride concentration was lowered by 49 % .\
RESULTS	Serum high density lipoprotein ( HDL ) cholesterol concentration was raised by 11 % with percentage shift towards the smaller HDL3c subfraction .\
RESULTS	The low-density lipoprotein cholesterol concentration remained unchanged .\
RESULTS	The proportion of glucose-intolerant subjects and insulin sensitivity were not altered by gemfibrozil .\
RESULTS	Plasma PAI-1 activity and fibrinogen levels were unaffected by gemfibrozil .\
RESULTS	The serum activity of gamma-glutamyltranspeptidase was lowered in all patients .\
CONCLUSIONS	Gemfibrozil is safe and effective with regard to its serum triglyceride-lowering potential .\
CONCLUSIONS	However , glucose intolerance , insulin resistance and elevated plasma PAI-1 activity , frequently seen in HTG patients , are not to be expected to be normalized by this drug .\
\
###15131545\
BACKGROUND	Increased low-density lipoprotein ( LDL ) and oxidized LDL cholesterol levels adversely affect endothelial function in patients with stable coronary artery disease ( CAD ) .\
BACKGROUND	Statin drugs are efficacious in primary and secondary prevention of clinical CAD events , but they have not been extensively studied as a treatment for ischemia during routine daily activities or during exercise , indicators of high-risk in patients with stable CAD .\
BACKGROUND	The purpose of the Vascular Basis for the Treatment of Myocardial Ischemia study is to determine whether aggressive lowering of LDL cholesterol level with atorvastatin , with or without supplemental antioxidant vitamins C and E , can improve endothelial function and ischemia during ambulatory electrocardiogram ( AECG ) monitoring and exercise treadmill testing ( ETT ) .\
METHODS	Patients are eligible when they have ischemia during an ETT and AECG monitoring and when their fasting total cholesterol level is < or = 250 mg/dL .\
METHODS	Eligible patients are randomized to receive 1 of 3 treatments : intensive atorvastatin to reduce LDL cholesterol level to < or = 80 mg/dL , intensive atorvastatin to reduce LDL cholesterol level to < or = 80 mg/dL plus antioxidant vitamins C and E , and control of diet and low-dose lovastatin , when needed , to reduce LDL cholesterol level < or = to 130 mg/dL .\
METHODS	Patients undergo endothelial function testing , 48-hour AECG monitoring , and ETT at randomization and at 6 and 12 months .\
RESULTS	A total of 300 patients have been randomized : 101 to receive atorvastatin alone , 103 to receive atorvastatin plus antioxidant vitamins , and 96 to receive placebo .\
RESULTS	Baseline characteristics are similar across treatment groups .\
CONCLUSIONS	The Vascular Basis study will provide important insight on the effects of aggressive management of dyslipidemia with statin drugs and antioxidant vitamins in patients with stable but high-risk CAD .\
\
###8921777\
BACKGROUND	The association of serum lipids with coronary heart disease has been studied extensively in middle-aged men and , to a lesser extent , in similar women .\
BACKGROUND	Less well defined are lipid variables predictive of CHD in individuals of age > or = 60 years .\
RESULTS	The Systolic Hypertension in the Elderly Program recruited 4736 persons ( mean age , 72 years ; 14 % were black ; and 43 % were men ) .\
RESULTS	Mean systolic and diastolic blood pressures were 170 and 77 mm Hg , respectively .\
RESULTS	Baseline mean total cholesterol was 6.11 mmol/L ( 236 mg/dL ) ; HDL cholesterol , 1.39 mmol/L ( 54 mg/dL ) ; and non-HDL cholesterol , 4.72 mmol/L ( 182 mg/dL ) .\
RESULTS	Triglyceride levels were 1.62 mmol/L ( 144 mg/dL ) for fasting participants and 1.78 mmol/L for the total group .\
RESULTS	LDL cholesterol , estimated in fasting samples with triglycerides of < 4.52 mmol/L , averaged 3.98 mmol/L ( 154 mg/dL ) .\
RESULTS	Mean follow-up was 4.5 years .\
RESULTS	In multivariate Cox regression analyses , baseline total , non-HDL , and LDL cholesterol levels and the ratios of total , non-HDL , and LDL to HDL cholesterol were significantly related to CHD incidence .\
RESULTS	HDL cholesterol and triglycerides were not significant in these analyses .\
RESULTS	In fasting participants with triglyceride levels of < 4.52 mmol/L , a 1.03 mmol/L ( 40 mg/dL ) higher baseline total , non-HDL , or LDL cholesterol was associated with a 30 % to 35 % higher CHD event rate .\
CONCLUSIONS	The results of this study support the concept that serum lipids are CHD risk factors in older Americans .\
\
###25491514\
BACKGROUND	The lack of national oral health policy and organized school dental health programs in the country call for affordable , accessible , and sustainable strategies .\
OBJECTIVE	The objective was to compare the oral hygiene , plaque , gingival , and dental caries status among rural children receiving dental health education by qualified dentists and school teachers with and without supply of oral hygiene aids .\
METHODS	This interventional study was conducted among 15-year-old children selected randomly from four schools in Nalgonda district between September 2009 and February 2010 .\
METHODS	Schools were divided into four different intervention groups .\
METHODS	The intervention groups varied in the form of intervention provider and frequency of intervention one of which being the control group .\
METHODS	The oral hygiene , plaque , gingival , and dental caries status was assessed at baseline and 6 months following the intervention .\
METHODS	SPSS 16 was used for analysis .\
RESULTS	The preintervention and postintervention comparison within each group revealed a substantial reduction in mean oral hygiene index-simplified ( OHI-S ) , plaque index ( PI ) , and gingival index ( GI ) at postintervention compared to baseline in group 4 ( 1.26 , 0.87 , and 0.74 , respectively ) followed by group 3 ( 0.14 , 0.37 , and 0.12 , respectively ) .\
RESULTS	The OHI-S , PI , and GI scores increased in group 1 ( 0.66 , 0.37 , and 0.34 , respectively ) and group 2 ( 0.25 , 0.19 , and 0.14 , respectively ) .\
RESULTS	Mean decayed , missing filled surfaces score between the groups was not statistically significant at baseline and postintervention .\
CONCLUSIONS	The dramatic reductions in the OHI-S , PI , and GI scores in the group supplied with oral hygiene aids call for supplying low cost fluoridated toothpastes along with toothbrushes through the school systems in rural areas .\
\
###18504547\
OBJECTIVE	To determine whether 6 weeks of daily , moderate alcohol consumption increases expression of the gene encoding adiponectin ( ADIPOQ ) and plasma levels of the protein , and improves insulin sensitivity in postmenopausal women .\
METHODS	In a randomised , open-label , crossover trial conducted in the Netherlands , 36 apparently healthy postmenopausal women who were habitual alcohol consumers , received 250 ml white wine ( approximately 25 g alcohol/day ) or 250 ml of white grape juice ( control ) daily during dinner for 6 weeks .\
METHODS	Randomisation to treatment allocation occurred according to BMI .\
METHODS	Insulin sensitivity and ADIPOQ mRNA and plasma adiponectin levels were measured at the end of both periods .\
METHODS	Insulin sensitivity was estimated using the homeostasis model assessment of insulin resistance ( HOMA-IR ) .\
METHODS	Levels of ADIPOQ mRNA in subcutaneous adipose tissue were determined by RT-PCR .\
RESULTS	All subjects completed the study .\
RESULTS	Six weeks of white wine consumption reduced fasting insulin ( mean + / - SEM 40.0 + / - 3.4 vs 46.5 + / - 3.4 pmol/l ; p < 0.01 ) and HOMA-IR ( 1.42 + / - 0.13 vs 1.64 + / - 0.13 ; p = 0.02 ) compared with 6 weeks of grape juice consumption .\
RESULTS	ADIPOQ mRNA levels ( 1.09 + / - 0.15 vs 0.98 + / - 0.15 ; p = 0.04 ) and plasma levels of total ( 13.1 + / - 0.8 vs 12.0 + / - 0.8 microg/ml ; p < 0.001 ) and high molecular weight ( HMW ) adiponectin ( 9.9 + / - 1.2 vs 8.8 + / - 1.2 microg/ml ; p = 0.02 ) significantly increased after alcohol compared with juice consumption .\
RESULTS	Changes in ADIPOQ mRNA levels correlated with changes in plasma levels of total adiponectin ( rho = 0.46 ; p < 0.01 ) .\
RESULTS	Both fasting triacylglycerol ( 8.2 % ; p = 0.04 ) and LDL-cholesterol levels ( 7.8 % ; p < 0.0001 ) decreased , whereas HDL-cholesterol increased ( 7.0 % ; p < 0.0001 ) after prolonged moderate alcohol intake .\
RESULTS	No notable adverse effects were reported .\
CONCLUSIONS	Moderate alcohol consumption for 6 weeks improves insulin sensitivity , adiponectin levels and lipid profile in postmenopausal women .\
CONCLUSIONS	Furthermore , these data suggest a transcriptional mechanism leading to the alcohol-induced increase in adiponectin plasma levels .\
\
###22165459\
OBJECTIVE	To compare the efficacy of maxillary infiltration anesthesia with 0.5 % plain ropivacaine or 2 % lidocaine with epinephrine 1:100,000 .\
METHODS	60 volunteers received 1.8 ml of the anesthetic for infiltration anesthesia of maxillary central and lateral incisors and canine teeth .\
METHODS	The onset time and duration of pulp anesthesia were assessed with an electric pulp tester .\
METHODS	The duration time of numbness of the upper lip was also monitored .\
METHODS	Blood pressure and heart rate were measured before and after administration of the solution .\
RESULTS	The efficacy of anesthesia of the lateral and central incisors was 100 % for both anesthetics .\
RESULTS	There were small insignificant differences in effectiveness of canine pulp anesthesia .\
RESULTS	The mean onset time was significantly shorter for ropivacaine -- 2.2 minutes vs. 5.1 for lidocaine .\
RESULTS	Ropivacaine also had a significantly longer duration of action -- mean time 79.2 minutes .\
RESULTS	Ropivacaine caused statistically significant increases in blood pressure and heart rate .\
\
###7625499\
OBJECTIVE	The effects of vitamin A supplementation on morbidity of children born to human immunodeficiency virus ( HIV ) - infected women were evaluated in a population where vitamin A deficiency is not endemic .\
METHODS	A randomized , placebo-controlled trial of vitamin A supplementation was carried out in 118 offspring of HIV-infected women in Durban , South Africa .\
METHODS	Those assigned to receive a supplement were given 50,000 IU of vitamin A at 1 and 3 months of age ; 100,000 IU at 6 and 9 months ; and 200,000 IU at 12 and 15 months .\
METHODS	Morbidity in the past month was then recalled at each follow-up visit .\
METHODS	Analysis was based on 806 child-months .\
RESULTS	Among all children , the supplemented group had lower overall morbidity than the placebo group ( OR = 0.69 ; 95 % confidence interval [ CI ] = 0.48 , 0.99 ) .\
RESULTS	Among the 85 children of known HIV status ( 28 infected , 57 uninfected ) , morbidity associated with diarrhea was significantly reduced in the supplemented infected children ( OR = 0.51 ; 95 % CI = 0.27 , 0.99 ) , whereas no effect of supplementation on diarrheal morbidity was noted among the uninfected children .\
CONCLUSIONS	In a population not generally vitamin A deficient , vitamin A supplementation for children of HIV-infected women appeared to be beneficial , reducing morbidity .\
CONCLUSIONS	The benefit was observed particularly for diarrhea among HIV-infected children .\
\
###21182509\
BACKGROUND	Atopic dermatitis ( AD ) is a chronic skin disease resulting in a profound deterioration in quality of life .\
BACKGROUND	The FSL is a newly developed phototherapy device generating full-spectrum light ( FSL ) with a continuous wavelength ( 320-5000 nm ) .\
BACKGROUND	This study aimed to evaluate the efficacy and safety of FSL phototherapy in AD .\
METHODS	We enrolled 38 patients with moderate to severe AD in this open , randomized , controlled , prospective study .\
METHODS	In the FSL-irradiated group ( 20 patients ) , irradiation was conducted twice per week for 4 consecutive weeks .\
METHODS	In the control group ( 18 patients ) , only emollient application was allowed .\
METHODS	SCORing Atopic Dermatis ( SCORAD ) values were obtained at baseline , week 4 and 8 .\
METHODS	Patients were asked to give subjective assessments of improvement and laboratory tests including serum eosinophil counts , ECP levels , IgE levels and 22 cytokine levels were performed .\
RESULTS	In the FSL-irradiated group , the mean SCORAD value decreased significantly after 4 weeks of phototherapy and remained reduced for a further 4 weeks after the cessation of treatment .\
RESULTS	In the control group , the mean SCORAD value did not change significantly over the study period .\
RESULTS	Patients ' subjective assessments indicated good to excellent responses in 75 % of the FSL-irradiated group , by contrast with 50 % of the control group .\
RESULTS	The mean values for serum eosinophil counts , IL-4 and IL-5 levels decreased significantly after FLS phototherapy .\
RESULTS	No serious adverse effects were reported .\
CONCLUSIONS	In this study , we showed that FSL phototherapy can be an effective and safe treatment option in AD .\
\
###16423089\
OBJECTIVE	Metronidazole and tetracycline-based second-line quadruple therapy , widely used for Helicobacter pylori infection , often ends up in failure due to antibiotic resistance and poor compliance in Korea .\
OBJECTIVE	Our aim is to evaluate the efficacy and tolerability of moxifloxacin-based triple therapy as an alternative second-line treatment for H. pylori infection .\
METHODS	The subjects consisted of 85 patients infected with H. pylori , in whom initial proton pump inhibitor triple therapy had failed .\
METHODS	They were randomized to receive the following 7-day therapy : 1 , moxifloxacin 400 mg q.d. , esomeprazole 20 mg b.i.d. , and amoxicillin 1 g b.i.d. ; and 2 , esomeprazole 40 mg b.i.d. , tripotassium dicitrate bismuthate 300 mg q.i.d. , metronidazole 500 mg t.i.d. , and tetracycline 500 mg q.i.d. Eradication rates , drug compliance , and side-effect rates of each group were evaluated .\
RESULTS	The eradication rates were 75.6 and 83.8 % with moxifloxacin triple therapy , and 54.5 and 72.7 % with quadruple therapy by intention-to-treat ( p = .042 ) and per-protocol analyses ( p = .260 ) , respectively .\
RESULTS	Moxifloxacin triple therapy was significantly superior to quadruple therapy in terms of side-effect rates ( p = .039 ) .\
RESULTS	Compliance for therapy , i.e. , the percentage of tablets taken ( > 85 % ) , was 90.2 and 75.0 % , numerically higher in moxifloxacin triple therapy group than in quadruple therapy group , but without statistical difference ( p = .065 ) .\
CONCLUSIONS	Moxifloxacin-based triple therapy showed high eradication rates with few side effects and good drug compliance , suggesting this regimen could be a safe and effective option as second-line therapy for H. pylori infection in Korea .\
\
###10322888\
OBJECTIVE	To study the treatment of diabetic cardio-vascular autonomous neuropathy ( DCVAN ) by TCM-WM following the principle of promoting blood circulation to remove blood stasis .\
METHODS	Sixty patients with DCVAN were randomly divided into two groups , the treatment group ( 30 patients ) were treated with combined TCM-WM therapy .\
METHODS	Based on the control of blood sugar by WM effectively , then use TCM-Tangxinshen ( [ symbol : see text ] , TXS ) with the function of supplementing the Qi and nourishing Yin , promoting blood circulation to remove blood stasis .\
METHODS	Thirty cases of the control group were treated with WM alone .\
METHODS	The course of treatment was three months .\
RESULTS	The total effective rate of the treatment group and the control group was 77.3 % and 33.4 % respectively , which were significantly different statistically ( P < 0.005 ) .\
CONCLUSIONS	The therapeutic effect of TCM-WM was better than that of WM.\
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###1918785\
OBJECTIVE	To compare the efficacy and safety of ciprofloxacin and ceftriaxone in patients with nursing home-acquired lower respiratory tract infections requiring initial hospitalization .\
METHODS	Prospective , randomized trial .\
METHODS	Extended care nursing homes affiliated with a teaching hospital .\
METHODS	Fifty patients aged 60 years or older with normal or mildly impaired renal function admitted to the hospital for treatment of lower respiratory tract infections .\
METHODS	Twenty-four patients received initial therapy with intravenous ciprofloxacin , 200 mg every 12 hours ( 19 patients ) or 400 mg every 12 hours ( 5 patients ) during the acute phase followed by 750 mg orally every 12 hours during the convalescence phase .\
METHODS	Twenty-six patients received initial therapy with intravenous ceftriaxone , 2 g every 24 hours during the acute phase followed by 1 g administered intramuscularly every 24 hours during the convalescent phase .\
METHODS	The total duration of therapy was 14 days .\
METHODS	Successful outcome was defined as resolution or marked improvement in clinical signs and symptoms of lower respiratory tract infection upon completion of the treatment course .\
RESULTS	Twelve ( 50 % ) of the ciprofloxacin-treated and 14 ( 54 % ) of ceftriaxone-treated patients had successful outcomes .\
RESULTS	Recurrent oropharyngeal aspiration was the reason for treatment failure in most patients refractory to either antibiotic .\
RESULTS	Mortality during therapy was 8 % in each group .\
RESULTS	From 21 satisfactory sputum specimens collected , S. pneumoniae was the most common isolate , followed by H. influenzae and other Gram-negative bacteria .\
RESULTS	Ciprofloxacin therapy was well tolerated ; ceftriaxone therapy was discontinued in two patients ( 8 % ) due to adverse reactions ( intramuscular pain and drug fever ) .\
CONCLUSIONS	Sequential intravenous/oral ciprofloxacin appears to be as safe and effective as sequential intravenous/intramuscular ceftriaxone .\
CONCLUSIONS	The optimal dosage of intravenous ciprofloxacin in this patient population appears to be 400 mg every 12 hours ; however , additional clinical and pharmacokinetic studies with this regimen are warranted .\
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###21353105\
BACKGROUND	Intravenous acetaminophen has been approved in Europe and elsewhere for the treatment of acute pain and fever , and was recently approved by the US Food and Drug Administration ( FDA ) for the management of mild to moderate pain , the management of moderate to severe pain with adjunctive opioid analgesics , and the reduction of fever .\
OBJECTIVE	The aim of this work was to evaluate the analgesic efficacy and safety of repeated doses of 2 dosing regimens of intravenous acetaminophen compared with placebo over 24 hours in subjects with moderate to severe pain after abdominal laparoscopic surgery .\
METHODS	This double-blind , placebo-controlled , parallel-group study was conducted at 17 sites in the United States and enrolled adult subjects ( aged 18-80 years ) who were randomized to 4 groups ( IV acetaminophen 1000 mg [ 100 mL ] q6h ; IV acetaminophen 650 mg [ 65 mL ] q4h ; IV placebo 100 mL q6h ; or IV placebo 65 mL q4h ) , each given as a 15-minute infusion after surgery for 24 hours .\
METHODS	An open-label extension was offered to all subjects who remained in the hospital beyond the study period .\
METHODS	Two subjects ( 1 in the placebo 100 mL q6h group and 1 in the IV acetaminophen 1000 mg q6h group ) were enrolled in the open-label extension and were eligible to receive unblinded IV acetaminophen 1000 mg .\
METHODS	Before randomization , the choice of opioid for patient-controlled analgesia ( PCA ) rescue was left to the investigator ; however , acetaminophen-containing products , NSAIDs , and aspirin were not allowed .\
METHODS	The morning after abdominal laparoscopic surgery procedure , subjects ' PCA was withheld until pain intensity ( PI ) was moderate ( 2 ) or severe ( 3 ) on a categorical scale ( range , 0-3 ) and between 40 and 70 mm , inclusive , on a 100-mm visual analog scale , at which point they were randomized .\
METHODS	After the first dose of study medication , intravenous rescue was restricted to morphine or hydromorphone , and oral rescue was restricted to morphine or oxycodone immediate-release tablets .\
METHODS	Efficacy analyses were performed using the modified intent-to-treat ( mITT ) population , defined as all randomized subjects who received 1 complete dose of study medication before requesting rescue medication , and who had 1 completed PI/pain relief ( PR ) assessment after baseline .\
METHODS	The primary efficacy end point was the weighted sum of PI differences over 24 hours ( SPID24 ) using an ANCOVA model .\
METHODS	Time to meaningful PR was documented after the first dose of study medication using a double-stopwatch method : at T0 , 2 stopwatches were started , and subjects were instructed to stop the first stopwatch when they felt perceptible PR and the second when it became meaningful .\
METHODS	Safety was assessed via spontaneous adverse event ( AE ) reporting and laboratory tests .\
RESULTS	A total of 349 subjects were screened before elective surgery for eligibility .\
RESULTS	Of these , 244 subjects were randomized to a study arm ( IV acetaminophen 1000 mg [ n = 92 ] ; IV acetaminophen 650 mg [ n = 42 ] ; IV placebo 100 mL [ n = 43 ] ; or IV placebo 65 mL [ n = 67 ] ) and included in the ITT population , of whom 81.1 % ( 198/244 ) were women and 87.3 % ( 213/244 ) were white ; the mean ( SD ) age was 46.2 ( 12.51 ) years ( range , 18-78 years ) , and the mean weight was 174.3 ( 35.7 ) lb ( range , 103-284 lb ) .\
RESULTS	There was an allocation error in the contract research organization 's program linking group assignment and kit randomization ; therefore , the original randomization procedure was replaced with a modified randomization schedule created by an independent biostatistician under the supervision of the FDA .\
RESULTS	The mITT population included 241 subjects ; of these , 227 completed 24 hours of treatment .\
RESULTS	Four subjects withdrew before completing treatment because of AEs ( 1 subject in the placebo group because of fever and 3 in the IV acetaminophen 1000 mg q6h group because of infusion-site pain [ n = 1 ] or infiltration [ n = 2 ] ) , 8 because of withdrawal of consent , 2 because of early discharge from the hospital , and 2 for other reasons .\
RESULTS	Only 2 subjects participated in the elective open-label extension .\
RESULTS	Both intravenous acetaminophen dosing regimens were associated with significantly reduced SPID24 compared with placebo ( 1000 mg q6h , P < 0.007 ; 650 mg q4h , P < 0.019 ) .\
RESULTS	Among the mITT population , SPID24 ( using nonimputed data after first rescue : 1000 mg q6h , P < 0.001 ; 650 mg q4h , P = 0.020 ) , sum of PR scores over 24 hours ( 1000 mg q6h , P < 0.001 ; 650 mg q4h , P = 0.003 ) and 12 hours ( 1000 mg q6h , P < 0.001 ; 650 mg q4h , P = 0.001 ) , and subjects ' global evaluations at 24 hours ( 1000 mg q6h , P < 0.001 ; 650 mg q4h , P = 0.005 ) were statistically significant in favor of both acetaminophen dosing regimens compared with the combined placebo group .\
RESULTS	Time to meaningful PR ( by double stopwatch method ) after the first dose was significantly shorter among subjects who received IV acetaminophen 1000 mg compared with subjects in the placebo 100 mL group ( median of 24.9 vs 53.9 minutes , respectively ) .\
RESULTS	The most common overall AEs ( ie , those that occurred in > 10 % of any group ) were constipation , flatulence , nausea , and headache .\
RESULTS	The frequency of treatment-emergent AEs ( TEAEs ) across the treatment groups was not statistically significant .\
RESULTS	Most TEAEs were deemed to be unrelated to study medication .\
RESULTS	There were 6 subjects with serious TEAEs ( 1 [ 0.9 % ] in the IV acetaminophen 1000 mg group , 3 [ 7.0 % ] in the IV acetaminophen 650 mg group , and 2 [ 1.8 % ] in the placebo group ) .\
RESULTS	There was 1 ( 2.3 % ) related hepatic TEAE ( transaminase increased ) in the placebo group .\
CONCLUSIONS	Both regimens of intravenous acetaminophen ( 1000 mg q6h and 650 mg q4h ) were associated with statistically significant analgesic efficacy compared with placebo and were well tolerated in these adults after abdominal laparoscopic surgery .\
CONCLUSIONS	ClinicalTrials.gov identifier : NCT00564486 .\
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###18543484\
OBJECTIVE	To observe the clinical therapeutic effect of Airening Suppository ( ARN ) on carcinoma fever .\
METHODS	Adopting randomized and double-blinded method , 54 patients with carcinoma fever were randomly assigned to the observation group and the control group , who were treated respectively with ARN and indomethacin suppository by anal administering , 7 days as one treatment course .\
METHODS	The effect on body temperature on patients and side effect occurred were observed 7 days after discontinuation of the medication , and patients ' serum tumor necrosis factor alpha ( TNF-alpha ) , interleukin-1beta were determined by RIA , routine test of blood , urine and stool , liver and renal function were tested as well .\
METHODS	Body temperature , changes of clinical symptoms , and adverse reaction were observed .\
RESULTS	The effective rate of fever abating was 86.7 % in the observation group and 66.7 % in the control group , showing significant difference between them ( chi2 = 8.06 , P < 0.05 ) .\
RESULTS	After treatment , serum levels of TNF-alpha and IL-1beta in the observation group were much lower than those in the control group ( t = 7.477 , t = 3.492 , P < 0.01 ) .\
RESULTS	Besides , patients ' chief clinical symptoms and quality of life were markedly improved in the observation group ( t = 4.71 , P < 0.05 , chi2 = 7.38 , P < 0.05 ) , all better than those in the control group ( P < 0.05 ) .\
RESULTS	No evident effect on peripheral blood figure , or harmful impact on heart , liver and kidney function was found .\
CONCLUSIONS	Airening Suppository has a standing and stable fever abating effect in treating cancerous fever with no obvious adverse reaction , so it is worthy of clinical use and spreading .\
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###16909881\
BACKGROUND	The health provider on a space exploration mission can not evacuate a patient to Earth .\
BACKGROUND	Contingency plans for medical intervention must be designed for autonomy .\
BACKGROUND	This study measured the effect of microgravity on performance of fine motor skills such as basic surgical tasks .\
METHODS	Eight subjects , six with medical and two with non-medical backgrounds , were evaluated during parabolic microgravity flights aboard NASA 's KC-135 .\
METHODS	We evaluated their skill in tying surgical knots on simulated skin made of silicone using standard techniques for minimally invasive surgery .\
METHODS	LabView software was developed to archive forces applied to the laparoscopic tool handles during knot-tying .\
METHODS	Studies were controlled for medication ( ScopeDex ) and the aircraft environment .\
RESULTS	All participants completed the tests successfully .\
RESULTS	The data indicated that increased force was applied to the instruments and knot quality decreased during flight compared with ground control sessions .\
CONCLUSIONS	Specific metrics of surgical task performance are essential in developing education modules for providers of medical care during exploration-class missions .\
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###24548816\
BACKGROUND	Skin-to-skin contact reduces pain response in preterm infants subjected to minor painful procedures , such as heel lance .\
BACKGROUND	Diaper change is a procedure performed several times daily in hospitalized preterm infants .\
BACKGROUND	Routine care giving tasks such as diaper change may be stressful for the infant .\
OBJECTIVE	The purpose of this study was to investigate whether diaper change induces stress and if skin-to-skin contact could reduce such stress , measured by changes in skin conductance .\
METHODS	This was a randomized crossover pilot study in 19 preterm infants with gestational age between 28 and 34 weeks .\
METHODS	The diaper change procedure was done twice in each infant , once during skin-to-skin contact , and once in incubator or bed with the mother present .\
METHODS	During diaper change heart rate ( HR ) , peripheral oxygen saturation ( SpO2 ) , and changes in skin conductance ( SC ) peaks per sec , using the Skin Conductance Algesimeter ( SCA ) , were registered .\
RESULTS	The mean SC peaks/sec increased/decreased significantly under/after change of diapers which thereby underpins that this is a stressful procedure for the preterm infant .\
RESULTS	Skin-to-skin contact ( SSC ) entails significantly lower stress levels ( p < 0.05 ) compared to diaper changed in an incubator/bed measured by the SCA .\
CONCLUSIONS	Diaper change is a stressful procedure for preterm infants and may be ameliorated by skin-to-skin contact .\
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###21596324\
OBJECTIVE	This study evaluated the effect of pravastatin pre-treatment on post-procedural index of microcirculatory resistance ( IMR ) values that are introduced for assessing the status of the microcirculation independently of the epicardial area .\
BACKGROUND	Pre-treatment with statins decreased the incidence of cardiac enzyme increase after percutaneous coronary intervention ( PCI ) .\
BACKGROUND	However , 2 different etiologies , distal embolization of atheroma or ischemia caused by side-branch occlusion , can not be differentiated by measuring cardiac enzyme levels .\
METHODS	Eighty patients with stable angina were randomly assigned to either pravastatin treatment ( 20 mg/day , n = 40 ) or no treatment ( n = 40 ) 4 weeks before elective PCI .\
METHODS	An intracoronary pressure/temperature sensor-tipped guidewire was used .\
METHODS	Thermodilution curves were obtained during maximal hyperemia .\
METHODS	The IMR was calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time .\
METHODS	Creatine kinase-myocardial band and troponin I values were measured at baseline and at 8 and 24 h after PCI .\
RESULTS	Post-PCI troponin I levels tended to be lower in patients with pravastatin treatment ( median : 0.13 [ interquartile range ( IQR ) : 0.10 to 0.31 ] vs. 0.22 [ IQR : 0.10 to 0.74 ] ng/ml , p = 0.1 ) .\
RESULTS	However , patients with pravastatin treatment had significantly lower IMR than did patients without pravastatin treatment ( median : 12.6 [ IQR : 8.8 to 18.0 ] vs. 17.6 [ IQR : 9.7 to 33.9 ] , p = 0.007 ) .\
RESULTS	Multivariate analysis revealed that the lack of pravastatin pre-treatment was the only independent predictor of post-PCI impaired IMR ( p = 0.03 ) .\
CONCLUSIONS	Post-PCI measurement of the IMR confirmed that pre-treatment with pravastatin was associated with reduced microvascular dysfunction induced by PCI regardless of side branch occlusions .\
CONCLUSIONS	These data suggest that pre-treatment with statin is desired in patients undergoing elective PCI .\
CONCLUSIONS	( The Impact of Pravastatin Pretreatment on Periprocedural Microcirculatory Damage After Percutaneous Coronary Intervention ; UMIN000002885 ) .\
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###20448066\
OBJECTIVE	The objective of this study was to compare random urine albumin-creatinine ratio ( ACR ) with timed urine albumin excretion rate ( AER ) in patients with type 1 diabetes .\
METHODS	A total of 1186 participants in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications ( DCCT/EDIC ) Study provided spot urine specimens concurrent with 4-hour timed urine collections .\
METHODS	ACR and AER were compared using Bland-Altman plots , cross-classification of albuminuria status and its change over time , and within-person variability .\
RESULTS	Despite moderate correlation ( r = 0.62 ) , ACR levels ( mg/g ) were lower than AER levels ( mg/24 hr ) .\
RESULTS	This difference was greatest for men .\
RESULTS	Gender-specific estimated AER ( eAER ) values were empirically derived from ACR .\
RESULTS	Comparing the eAER with measured AER , agreement of prevalent microalbuminuria and macroalbuminuria classification was fair to moderate , and classification of change in albuminuria status over time was different .\
RESULTS	Intraclass correlations were 0.697 for ACR and 0.803 for AER .\
RESULTS	Effects of DCCT intensive versus conventional diabetes therapy on urine albumin excretion or classification of albuminuria were similar using the eAER versus measured AER , as were the effects of the previous glycosylated hemoglobin .\
CONCLUSIONS	Systematic differences exist between urine ACR and AER , related to gender and other determinants of muscle mass .\
CONCLUSIONS	Use of ACR ( or eAER ) versus AER yields differences in classification of prevalent albuminuria states and changes in albuminuria states over time .\
CONCLUSIONS	These findings support the use of consistent ascertainment methods over time and further efforts to standardize and optimally interpret measurement of urine albumin excretion .\
\
###18620591\
BACKGROUND	In our study we compared the Ringer solution , which is the standard prime solution of our department , with the HES ( Hydroxyethyl starch ) 130-0 .4 solution , which can be a potential alternative prime solution with an indispensable material for the cardio-pulmonary bypass applications .\
METHODS	140 patients undergoing to CABG ( Coronary Artery Bypass Graft surgery ) were electively enrolled to the study .\
METHODS	1500 ml Ringer solution + 200 ml mannitol + 60 ml sodium bicarbonate + 150 U/kg heparin was used as a prime solution to start cardiopulmonary by-pass in 70 patients which was defined as group 1 .\
METHODS	On the other hand , 1500 ml HES 130 - 0.4 + 200 ml mannitol + 60 ml sodium bicarbonate + 150 U/kg heparin was used as a prime solution in 70 patients in group 2 .\
RESULTS	INR ( International Normalized Ratio ) , urea levels and blood platelet counts were significantly different between the groups .\
RESULTS	INR level was higher in group 1 , while blood urea and creatinine levels and platelet count were higher in group 2 at the end of the 12th and 24nd hours postoperatively ( p = 0.001 ) .\
RESULTS	In this study , it was shown that the usage of HES 130-0 .4 as a prime solution did not have negative effect on postoperative INR level , platelet count , the need for transfusion and the amount of drainage , despite the negative opinions that similar solutions caused coagulation disorders .\
RESULTS	Another interesting result of the study was that blood platelet count at 24th hour was statistically significantly higher in group 2 ( p = 0.001 ) .\
CONCLUSIONS	HES 130-0 .4 solution is an alternative colloidal solution which can be used as the prime solution or as a mixture with the crystalloids in cardio-pulmonary bypass applications .\
\
###16923003\
OBJECTIVE	High heart rates in chronic atrial fibrillation ( CAF ) is one of the factors responsible for hemodynamic alterations and may lead to tachycardiomyopathies .\
OBJECTIVE	The ventricular rate regulation ( VRR ) study evaluates the effect of ventricular rate regularization in CAF patients with preserved ventricular function , marked ventricular rate variability , and indications for pacemaker ( PM ) implantation owing to symptomatic pauses .\
OBJECTIVE	Rate regularization was achieved using VRR algorithm ( INSIGNIA pacemakers , Guidant Corp. , St. Paul , MN , USA ) .\
METHODS	One month after PM implantation , 58 patients followed two 3-month crossover periods ( VRR-OFF ; VRR-ON ) in which the VRR algorithm was randomized and compared to fixed rate stimulation at 60 ppm .\
METHODS	During follow-up visits a 6-minute walk test was performed under partially inhibited conditions ( PM at 40 ppm ) and ventricular response was recorded .\
METHODS	The following parameters were measured : mean ventricular rate ( MR ) , rate variability ( RR30 ) , rate recovery after exercise ( SLOPE = ( R-END - R-REC ) / ( R-END - 40 ) ) , R-END being the rate at end of walk and R-REC the rate 1 minute after exercise .\
RESULTS	The VRR algorithm decreased rate variability ( RR30 : -7.36 + / - 8.8 ; P < 0.01 ) without increasing ventricular rate ( MR : -1.11 + / - 8.3 P = NS ) , while SLOPE improved significantly ( SLOPE : +15.41 + / - 16.8 P < 0.01 ) .\
CONCLUSIONS	VRR effectively stabilizes rate , without increasing pacing rate above spontaneous rhythm and helps achieve a more favorable autonomic balance , improving rate recovery after exercise .\
\
###16980867\
BACKGROUND	The authors randomized and prospectively analyzed their clinical experience with the use of internal neodymium : yttrium-aluminum-garnet low-level laser-assisted lipoplasty compared with suction-assisted lipoplasty .\
METHODS	Suction-assisted lipoplasty was generated through a SmartLipo machine and delivered into the subcutaneous tissues through 2-mm solid optical probes .\
METHODS	Ipsilateral suction-assisted lipoplasty and contralateral laser-assisted lipoplasty were performed on one or more comparable topographic areas of the body in the same patient .\
METHODS	Laser-assisted lipoplasty and suction-assisted lipoplasty sides of 25 patients were compared with preoperative and postoperative photographs at 3 to 5 days , 12 to 15 days , and 6 to 11 months .\
METHODS	Statistical analysis considered surgeon and patient satisfaction , time used in the procedures , learning curves , lipocrits , operative technique , postoperative pain , edema , ecchymosis , time of recovery , body mass index , DNA proteins , free fatty acids , and cytologic patterns of post-laser-assisted lipoplasty and suction-assisted lipoplasty adipocyte architecture .\
METHODS	Photographs were sent to the patients ( blinded to the operated sides ) and two plastic surgeons unfamiliar with the cases for evaluation of results .\
RESULTS	All patients completed the preestablished follow-ups .\
RESULTS	No complications were observed .\
RESULTS	Less pain , lower lipocrits , higher triglycerides , and DNA cellular membrane traces were detected in the laser-assisted lipoplasty sides .\
RESULTS	All other considerations studied showed no differences with either technique in the three periods of the follow-up controls .\
RESULTS	Cytologic studies showed more damage of the adipocytes in the laser-assisted lipoplasty sides .\
CONCLUSIONS	No major clinical differences for suction-assisted lipoplasty versus laser-assisted lipoplasty were found .\
CONCLUSIONS	Higher concentrations of free-fatty acids after laser-assisted lipoplasty must alert us to possible hepatic and renal toxicity .\
\
###11829851\
OBJECTIVE	To confirm the effect of radical operation on single cells metastasis of gastrointestinal cancer .\
METHODS	One hundred and seventy two patients with gastrointestinal cancer were divided randomly into group I ( 111 cases , ordinary operation ) and group II ( 61 cases , operation after ligation of drained vessels ) .\
METHODS	Catheters were inserted into the portal vein during operation .\
METHODS	Blood was aspirated and contrifugated .\
METHODS	Anti-EMA monoclonal antibody marked the cancer cells , which were shown by ABC immunohistochemical staining .\
RESULTS	In the examinate group , 72 cases of gastrointestinal cancer were found positive cells among 111 cases ( positive rate 64.9 % ) .\
RESULTS	In the control group , 61 cases were tested and 13 cases were found positive cells ( positive rate 21.3 % ) with a highly significant difference between the two groups ( P < 0.005 ) .\
CONCLUSIONS	Ligating the relative blood vessel before the radical operation can prevent single cancer cells from metastasis via portal vein .\
\
###21492159\
OBJECTIVE	To compare the effects of lottery-based and fixed incentives on clinicians ' response to surveys .\
METHODS	Three randomized trials with fixed payments and actuarially equivalent lotteries .\
METHODS	Trial 1 compared a low-probability/high-payout lottery , a high-probability/low-payout lottery , and no incentive .\
METHODS	Trial 2 compared a moderate-probability/moderate-payout lottery with an unconditional fixed payment ( payment sent with questionnaire ) .\
METHODS	Trial 3 compared a moderate-probability/moderate-payout lottery with a conditional fixed payment ( payment promised following response ) .\
RESULTS	Neither the low-probability nor high-probability lotteries improved response compared with no incentive .\
RESULTS	Unconditional fixed payments produced significantly greater response than actuarially equivalent lotteries , but conditional fixed payments did not .\
CONCLUSIONS	Lottery-based incentives do not improve clinicians ' response rates compared with no incentives , and they are inferior to unconditional fixed payments .\
\
###25062857\
BACKGROUND	`` Practice effects '' ( PE ) , or performance improvements due to prior exposure to testing , are known to confound cognitive test results , particularly when short intervals occur between two test sessions .\
OBJECTIVE	We examined two subsamples with short or long re-test intervals from a recent clinical trial .\
METHODS	Thirty-four non-depressed adults with mild Huntington Disease ( HD ) participated .\
METHODS	Three cognitive tests were administered at screening and again at baseline , before active treatment randomization .\
METHODS	Half the sample had a 24-hour retest interval while the other half was > 6-days .\
RESULTS	The two groups differed on demographic/clinical factors ( age , Total Motor Score and Total Functional Capacity ) .\
RESULTS	After controlling for age and motor score , PE differences were found on three of the five UHDRS cognitive tests : the longer interval group showed larger PE on Symbol-Digit Modalities and Stroop color , while the rapid interval group had larger PE on Stroop interference .\
RESULTS	Controlling for screening cognitive performance yielded similar results .\
CONCLUSIONS	Length of interval between screening and baseline visits and level of disease severity may influence stability of UHDRS cognitive test results in clinical trials in HD .\
\
###15111377\
BACKGROUND	The prevalence of human immunodeficiency virus ( HIV ) disease is increasing among women , many of whom remain symptomatic with low weight and poor functional status .\
BACKGROUND	Although androgen levels may often be reduced in such patients , the safety , tolerability , and efficacy of testosterone administration in this population remains unknown .\
METHODS	A total of 57 HIV-infected women with free testosterone levels less than the median of the reference range and weight less than 90 % of ideal body weight or weight loss greater than 10 % were randomly assigned to receive transdermal testosterone ( 4 mg/patch ) twice weekly or placebo for 6 months .\
METHODS	Muscle mass was assessed by urinary creatinine excretion .\
METHODS	Muscle function was assessed by the Tufts Quantitative Muscle Function Test .\
METHODS	Treatment effect at 6 months was determined by analysis of covariance .\
METHODS	Results are mean + / - SEM unless otherwise specified .\
RESULTS	At baseline , subjects were low weight ( body mass index [ calculated as weight in kilograms divided by the square of height in meters ] 20.6 + / - 0.4 ) , with significant weight loss from pre-illness maximum weight ( 18.7 % + / - 1.2 % ) , and demonstrated reduced muscle function ( upper and lower extremity muscle strength , 83 % and 67 % , respectively , of predicted range ) .\
RESULTS	Testosterone treatment resulted in significant increases in testosterone levels vs placebo ( total testosterone : 37 + / - 5 vs -2 + / - 2 ng/dL [ 1.3 + / - 0.2 vs -0.1 + / - 0.1 nmol/L ] [ P < .001 ] ; free testosterone : 3.7 + / - 0.5 vs -0.4 + / - 0.3 pg/mL [ 12.8 + / - 1.7 vs -1.4 vs 1.0 pmol/L ] [ P < .001 ] ) and was well tolerated , without adverse effects on immune function , lipid and glucose levels , liver function , or body composition or the adverse effect of hirsutism .\
RESULTS	Muscle mass tended to increase ( 1.4 + / - 0.6 vs 0.3 + / - 0.8 kg ; P = .08 ) , and shoulder flexion ( 0.4 + / - 0.3 vs -0.5 + / - 0.3 kg ; P = .02 ) , elbow flexion ( 0.3 + / - 0.4 vs -0.7 + / - 0.4 kg ; P = .04 ) , knee extension ( 0.2 + / - 1.0 vs -1.7 + / - 1.3 kg ; P = .02 ) , and knee flexion ( 0.7 + / - 0.5 vs 0.3 + / - 0.7 kg ; P = .04 ) increased in the testosterone-treated compared with the placebo-treated subjects .\
CONCLUSIONS	Testosterone administration is well-tolerated and increases muscle strength in low-weight HIV-infected women .\
CONCLUSIONS	Testosterone administration may be a useful adjunctive therapy to maintain muscle function in symptomatic HIV-infected women .\
\
###8822685\
OBJECTIVE	To compare the effects of expiratory muscle training and sham training on respiratory muscle strength in patients with multiple sclerosis ( MS ) .\
METHODS	A randomized control trial ; subjects were randomly assigned to either expiratory muscle training or sham training .\
METHODS	Training and measurement of respiratory muscle pressures were conducted in patients ' homes .\
METHODS	Weekly home visits were conducted to assure compliance with the training protocols and to obtain measurements .\
METHODS	Twenty subjects with clinically definite MS and decreased expiratory muscle strength entered the study ; 10 subjects completed 3 months of expiratory training using a threshold training device and 5 subjects completed 3 months of sham training using the same device but without an expiratory training threshold load .\
METHODS	Respiratory muscle strength was assessed at baseline and after 1 , 2 , and 3 months of training ; maximal inspiratory and expiratory pressures were used as measures of respiratory muscle strength .\
RESULTS	There was a significant increase in expiratory muscle strength after 3 months of training when the expiratory training group was compared to the sham group ( p = .003 ) ; no significant change in inspiratory muscle strength was observed .\
CONCLUSIONS	The results of this pilot study suggest that the strength of the expiratory muscles of persons with MS can be increased through respiratory muscle training targeted to the expiratory muscles .\
CONCLUSIONS	Further research is indicated to determine if increasing the strength of the expiratory muscles in MS has an effect on clinical outcomes in this patient population .\
\
###20453546\
OBJECTIVE	To determine if a hyaluronic acid/carboxymethylcellulose ( HA/CMC ) sinus dressing reduces the rate of postoperative scarring .\
METHODS	In a randomized , matched-controlled , single-blinded study , following the completion of surgery , an HA/CMC dressing was randomly assigned to one side with the opposite unpacked side serving as a control .\
RESULTS	Fifty-three patients underwent surgery for chronic rhinosinusitis ( CRS ; 39 patients ) or CRS with nasal polyposis ( 14 patients ) .\
RESULTS	At the 8-week follow-up , there was no difference in synechiae on the HA/CMC side compared to the control ( p = 0.09 ) .\
RESULTS	HA/CMC-treated sinuses , however , demonstrated fewer synechiae in the first 2 weeks postoperatively compared to the control ( p = 0.01 ) , and were associated with significantly less nasal congestion at the 4-week ( p = 0.02 ) and 8-week follow-up visits ( 0.03 ) .\
CONCLUSIONS	There was no long-term difference in the rate of synechiae in the HA/CMC-treated sinus compared to the control .\
CONCLUSIONS	However , less severe nasal congestion and synechiae in the initial postoperative period may reduce the need for aggressive sinus debridement .\
\
###23291141\
OBJECTIVE	To compare the efficacy and feasibility of neoadjuvant chemoradiotherapy with docetaxel plus cisplatin or with cisplatin plus fluorouracil in the treatment of local advanced esophageal squamous cell carcinoma .\
METHODS	A total of 154 cases in the stage of cT3N0-1M0 were randomly assigned to two arms .\
METHODS	The arm A received 2 cycles of doctaxel 75 mg/m ( 2 ) plus cisplatin 25 mg/m ( 2 ) d1-3 and 40 Gy of radiation therapy , and the arm B received 2 cycles of cisplatin 25 mg/m ( 2 ) d1-3 plus fluorouracil 600 mg/m ( 2 ) d1 5 and 40 Gy of radiation therapy .\
METHODS	The surgery was performed 3 - 4 weeks later .\
RESULTS	Grade 3/4 toxicities occurred in 53.2 % of the patients in arm A and in 36.4 % of the patients in arm B ( P = 0.035 ) .\
RESULTS	Neutropenia occurred in 20.7 % of the patients in arm A and 5.6 % of the patients in arm B ( P = 0.004 ) .\
RESULTS	Nine patients aborted surgery due to tumor progression .\
RESULTS	71 patients underwent resection in 73 cases of the arm A and 69 patients underwent complete resection , 70 patients underwent resection in 72 cases and 70 complete resection of the arm B , respectively ( P > 0.05 ) .\
RESULTS	No mortality was noted .\
RESULTS	The overall complication rate was similar in the two arms ( 21.9 % vs. 23.6 % ) .\
RESULTS	Pathological complete response was achieved in 27 patients ( 35.1 % ) in the arm A and 16 patients ( 20.8 % ) in the arm B ( P = 0.048 ) .\
CONCLUSIONS	Neoadjuvant chemoradiotherapy with docetaxel plus cisplatin can be well tolerated and achieves a higher pathological complete response rate than with cisplatin plus fluorouracil .\
\
###25450879\
BACKGROUND	Neoangiogenesis is particularly abundant in small-cell lung cancer ( SCLC ) and is associated with poor prognosis .\
BACKGROUND	As a result of the promising nature of phase II studies , a randomized phase III trial was designed to assess the efficacy of adding bevacizumab to first-line chemotherapy with cisplatin-etoposide for treatment of extensive disease SCLC .\
BACKGROUND	We present the treatment rationale and study design of GOIRC trial ( FARM6PMFJM study ) , a multicenter randomized phase III study , supported by AIFA ( Agenzia Italiana del Farmaco ) .\
METHODS	Patients are randomized to receive either cisplatin 25 mg/m ( 2 ) and etoposide 100 mg/m ( 2 ) intravenously on days 1 to 3 ( control arm ) or the same chemotherapy combined with bevacizumab 7.5 mg/kg intravenously on day 1 ( experimental arm ) .\
METHODS	Treatment is repeated every 3 weeks and for a maximum of 6 courses .\
METHODS	Patients randomized to the experimental arm in the absence of disease progression after 6 cycles continue bevacizumab alone until progression or for a maximum of 18 courses .\
METHODS	Tumor assessment is done every 3 cycles .\
METHODS	Major eligibility criteria are : age 18 years ; histologically or cytologically documented extensive disease SCLC ; Eastern Cooperative Oncology Group performance status 2 ; adequate hematological , hepatic and renal functions ; no history of grade 2 or higher hemoptysis ; and no evidence of tumor cavitation .\
METHODS	The primary end point of this study is overall survival .\
METHODS	Secondary end points include response rate , time to progression , and toxicity .\
CONCLUSIONS	An interim futility analysis was performed by an Independent Data Monitoring Committee in September 2013 and the trial obtained approval to continue .\
CONCLUSIONS	As of July 31 , 2014 , 171 patients of 206 planned have been randomized .\
\
###18716497\
OBJECTIVE	To design microneedles that minimize pain , this study tested the hypothesis that microneedles cause significantly less pain than a 26-gauge hypodermic needle , and that decreasing microneedle length and the number of microneedles reduces pain in normal human volunteers .\
METHODS	Single microneedles with lengths ranging from 480 to 1450 microm , widths from 160 to 465 microm , thicknesses from 30 to 100 microm , and tip angles from 20 to 90 degrees ; and arrays containing 5 or 50 microneedles were inserted into the volar forearms of 10 healthy , human volunteers in a double-blinded , randomized study .\
METHODS	Visual analog scale pain scores were recorded and compared with each other and to the pain from a 26-gauge hypodermic needle .\
RESULTS	All microneedles investigated were significantly less painful than the hypodermic needle with microneedle pain scores varying from 5 % to 40 % of the hypodermic needle .\
RESULTS	Microneedle length had the strongest effect on pain , where a 3-fold increase in length increased the pain score by 7-fold .\
RESULTS	The number of microneedles also affected the pain score , where a 10-fold increase in the number of microneedles increased pain just over 2-fold .\
RESULTS	Microneedle tip angle , thickness , and width did not significantly influence pain .\
CONCLUSIONS	Microneedles are significantly less painful than a 26-gauge hypodermic needle over the range of dimensions investigated .\
CONCLUSIONS	Decreasing microneedle length and number of microneedles reduces pain .\
\
###24634003\
BACKGROUND	Using phase 3 trial data for sunitinib versus interferon ( IFN ) - in treatment-naive patients with metastatic renal cell carcinoma , retrospective analyses characterized sunitinib-associated fatigue and its impact on patient-reported health-related quality of life ( HRQoL ) .\
METHODS	Patients received sunitinib at a dose of 50 mg/day on a schedule of 4 weeks on/2 weeks off ( 375 patients ) or IFN - at a dose of 9 MU subcutaneously 3 times per week ( 360 patients ) .\
METHODS	HRQoL was self-assessed using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-15-item ( FKSI-15 ) questionnaire , with fatigue assessed using its Disease-Related Symptoms subscale .\
METHODS	Fatigue was also assessed by providers using Common Terminology Criteria for Adverse Events ( CTCAE ) .\
METHODS	A repeated-measures model ( M1 ) and random intercept-slope model ( M2 ) characterized sunitinib-associated fatigue over time .\
METHODS	Another repeated-measures model examined the relationship between HRQoL scores and CTCAE fatigue grade .\
RESULTS	M1 demonstrated that the initial increase in patient-reported fatigue with sunitinib was worst during cycle 1 , with mean values numerically better at subsequent cycles ; most pairwise comparisons of consecutive CTCAE fatigue cycle means were not found to be statistically significant .\
RESULTS	M2 demonstrated that the overall trend ( slope ) for patient-reported and CTCAE fatigue with sunitinib was not statistically different from 0 .\
RESULTS	The relationship between most HRQoL scores and CTCAE fatigue was close to linear regardless of treatment , with lower scores ( worse HRQoL ) corresponding to higher fatigue grade .\
RESULTS	The majority of HRQoL scores were better with sunitinib versus IFN - for the same CTCAE fatigue grade .\
CONCLUSIONS	Patients reported worse fatigue during the first sunitinib cycle .\
CONCLUSIONS	However , in subsequent consecutive cycles , less fatigue was reported with no statistically significant worsening .\
CONCLUSIONS	CTCAE fatigue assessment may not fully capture patient treatment experience .\
\
###1737157\
OBJECTIVE	To investigate the possible therapeutic role of omeprazole , a powerful proton pump inhibitor , in unselected patients presenting with upper gastrointestinal bleeding .\
METHODS	Double blind placebo controlled parallel group study .\
METHODS	Active treatment was omeprazole 80 mg intravenously immediately , then three doses of 40 mg intravenously at eight hourly intervals , then 40 mg orally at 12 hourly intervals .\
METHODS	Treatment was started within 12 hours of admission and given for four days or until surgery , discharge , or death .\
METHODS	The medical wards of University and City Hospitals , Nottingham .\
METHODS	1147 consecutive patients aged 18 years or more admitted over 40 months with acute upper gastrointestinal bleeding .\
METHODS	Mortality from all causes ; rate of rebleeding , transfusion requirements , and operation rate ; effect of treatment on endoscopic appearances at initial endoscopy .\
RESULTS	Of 1147 patients included in the intention to treat analysis , 569 received placebo and 578 omeprazole .\
RESULTS	No significant differences were found between the placebo and omeprazole groups for rates of transfusion ( 302 ( 53 % ) placebo v 298 ( 52 % ) omeprazole ) , rebleeding ( 100 ( 18 % ) v 85 ( 15 % ) ) , operation ( 63 ( 11 % ) v 62 ( 11 % ) ) , and death ( 30 ( 5.3 % ) v 40 ( 6.9 % ) ) .\
RESULTS	However , there was an unexpected but significant reduction in endoscopic signs of upper gastrointestinal bleeding in patients treated with omeprazole compared with those treated with placebo ( 236 ( 45 % ) placebo v 176 ( 33 % ) omeprazole ; p less than 0.0001 ) .\
CONCLUSIONS	Omeprazole failed to reduce mortality , rebleeding , or transfusion requirements , although the reduction in endoscopic signs of bleeding suggests that inhibition of acid may be capable of influencing intragastric bleeding .\
CONCLUSIONS	Our data do not justify the routine use of acid inhibiting drugs in the management of haematemesis and melaena .\
\
###8690639\
OBJECTIVE	Claims for the value of hyperthermia as an adjunct to radiotherapy in the treatment of cancer have mostly been based on small Phase I or II trials .\
OBJECTIVE	To test the benefit of this form of treatment , randomized Phase III trials were needed .\
METHODS	Five randomized trials addressing this question were started between 1988 and 1991 .\
METHODS	In these trials , patients were eligible if they had advanced primary or recurrent breast cancer , and local radiotherapy was indicated in preference to surgery .\
METHODS	In addition , heating of the lesions and treatment with a prescribed ( re ) irradiation schedule had to be feasible and informed consent was obtained .\
METHODS	The primary endpoint of all trials was local complete response .\
METHODS	Slow recruitment led to a decision to collaborate and combine the trial results in one analysis , and report them simultaneously in one publication .\
METHODS	Interim analyses were carried out and the trials were closed to recruitment when a previously agreed statistically significant difference in complete response rate was observed in the two larger trials .\
RESULTS	We report on pretreatment characteristics , the treatments received , the local response observed , duration of response , time to local failure , distant progression and survival , and treatment toxicity of the 306 patients randomized .\
RESULTS	The overall CR rate for RT alone was 41 % and for the combined treatment arm was 59 % , giving , after stratification by trial , an odds ratio of 2.3 .\
RESULTS	Not all trials demonstrated an advantage for the combined treatment , although the 95 % confidence intervals of the different trials all contain the pooled odds ratio .\
RESULTS	The greatest effect was observed in patients with recurrent lesions in previously irradiated areas , where further irradiation was limited to low doses .\
CONCLUSIONS	The combined result of the five trials has demonstrated the efficacy of hyperthermia as an adjunct to radiotherapy for treatment of recurrent breast cancer .\
CONCLUSIONS	The implication of these encouraging results is that hyperthermia appears to have an important role in the clinical management of this disease , and there should be no doubt that further studies of the use of hyperthermia are warranted .\
\
###10192750\
OBJECTIVE	A double-blind , placebo-controlled parallel study was conducted on the effect of mibefradil , both an L - and T-type Ca2 + - channel blocker with a more selective blockade of T-type channels , administered once daily for 1 week to normal male subjects , on blood pressure , intracellular cationic concentrations , sodium-proton exchange rate and 3H-thymidine incorporation in peripheral blood mononuclear cells ( PBMC ) .\
METHODS	After a 1-week run-in period on placebo , the subjects ( n = 40 ) were allocated to a placebo or a mibefradil group .\
METHODS	Placebo or 50 mg mibefradil was administered once daily in the morning for 1 week .\
METHODS	All subjects were investigated at baseline and after 1 week of placebo or mibefradil administration .\
METHODS	Standing or recumbent blood pressure and heart rate of subjects in the mibefradil group was decreased ( P < 0.05 or less ) compared with that of subjects in the placebo group .\
RESULTS	Decreased ( P < 0.001 ) intracellular free Ca2 + concentration and reduced ( P < 0.001 ) 3H-thymidine incorporation in the PBMC were observed in the mibefradil-treated subjects .\
RESULTS	The intracellular sodium , potassium or magnesium concentration as well as the sodium-proton exchange rate were not changed during mibefradil administration .\
CONCLUSIONS	The blood pressure lowering action of mibefradil in men is accompanied by a decrease in intracellular free Ca2 + concentration .\
CONCLUSIONS	Mibefradil also reduced the 3H-thymidine incorporation or de novo DNA synthesis in PBMC by modulating the calcium homeostasis .\
\
###12734763\
BACKGROUND	The tricyclic antidepressant trimipramine exhibits several features ( e. g. , dopaminergic effect , molecular structure similar to a neuroleptic , receptor-binding profile similar to clozapine ) that suggest its potential as an antipsychotic medication .\
BACKGROUND	The aim of the study was to investigate the antipsychotic potential of trimipramine in a controlled clinical trial comparing its antipsychotic efficacy with that of a neuroleptic .\
METHODS	In a German multi-center , randomized , double-blind trial , the antipsychotic efficacy of trimipramine was compared with that of the phenothiazine neuroleptic perazine , using the Brief Psychiatric Rating Scale ( BPRS ) , the Positive and Negative Syndrome Scale ( PANSS ) , and Clinical Global Impressions ( CGI ) .\
METHODS	Antidepressant efficacy of both agents was measured by use of the Bech-Rafaelsen Melancholia Scale ( BRMES ) .\
METHODS	Ninety-five patients with acute schizophrenia ( DSM-III-R ) and a BPRS total score > 40 at baseline were treated with either 300-400 mg trimipramine or 450-600 mg perazine for 5 weeks .\
RESULTS	Therapeutic equivalence of both treatments ( in the dosages used ) could not be demonstrated ( change in BPRS total score , per-protocol [ PP ] analysis , one-sided equivalence testing ) .\
RESULTS	However , intention-to-treat ( ITT ) as well as PP analysis showed a statistically significant decrease in the BPRS total scores in both treatment groups ( PP : trimipramine , 56.5 + / - 9.8 to 44.1 + / - 17.9 ; perazine , 56.4 + / - 10.8 to 37.9 + / - 12.9 ) .\
RESULTS	Significant decreases in all BPRS and PANSS subscores as well as CGI results and response rate support the antipsychotic efficacy of trimipramine .\
RESULTS	The BRMES total scores significantly decreased in both treatment groups without showing a significant difference between the two agents .\
RESULTS	Trimipramine was better tolerated than perazine and did not elicit extrapyramidal symptoms .\
CONCLUSIONS	Trimipramine failed to exhibit therapeutic equivalence to perazine in the dosages used .\
CONCLUSIONS	However , there was evidence of a substantial antipsychotic effect of trimipramine .\
CONCLUSIONS	It may be a useful medication if depressive symptoms in psychotic patients require antidepressant treatment or if other antipsychotics can not be administered .\
\
###20691795\
OBJECTIVE	To investigate the association between systemic and local inflammation and incident and progressive radiographic secondary osteoarthritis ( OA ) in interphalangeal joints ( IPJs ) over 3 years in rheumatoid arthritis ( RA ) patients and the effect of tumor necrosis factor alpha ( TNF - ) inhibitor infliximab on secondary OA in IPJs .\
METHODS	In the present observational longitudinal study baseline and 3-year hand X-rays of 416 recent-onset RA patients were scored for osteophytes and erosions in IPJs , blinded for time , using Osteoarthritis Research Society International atlas and Sharp-van der Heijde score .\
METHODS	The associations between inflammatory factors and incident and progressive secondary OA in distal IPJs ( DIPJs ) and proximal IPJs ( PIPJs ) and the effect of infliximab compared to disease-modifying anti-rheumatic drug treatment on secondary OA were analyzed by multivariable regression and generalised estimating equations analyses .\
RESULTS	Sixty-seven percent of the patients were female with , at baseline , a mean age of 54 years and OA present in DIPJs and PIPJs in 37 % and 13 % .\
RESULTS	Three years later , new secondary OA in DIPJs and PIPJs was seen in 11 % and 10 % , and progressive secondary OA in 36 % and 35 % .\
RESULTS	High erythrocyte sedimentation rate over 3 years and progressive erosive damage were risk factors for incident secondary OA in DIPJs , but not in PIPJs .\
RESULTS	At joint level , progression of erosions was associated with both incident and progressive secondary OA , only in DIPJs .\
RESULTS	Infliximab treatment was associated with lower incident secondary OA in PIPJs [ relative risk 0.5 ( 95 % confidence interval 0.2 , 1.0 ) ] , independent of decrease in inflammation .\
CONCLUSIONS	Incident and progressive secondary OA in DIPJs over 3 years was associated with high inflammatory activity in RA .\
CONCLUSIONS	Infliximab treatment reduced incident secondary OA in PIPJs independent of decrease in inflammation , suggesting that anti-TNF - therapy might be effective against secondary hand OA via other pathways than suppression of inflammation .\
CONCLUSIONS	Further studies in populations of primary hand OA are necessary to determine the role of anti-TNF - in treatment of primary hand OA .\
\
###25304934\
BACKGROUND	Lumbosacral radicular syndrome ( LRS ) is a self-limiting , benign , painful and impairing condition caused by lumbar disc herniation and inflammatory processes around the nerve root .\
BACKGROUND	Segmental epidural steroid injections ( SESIs ) are helpful to reduce radicular pain on a short-term basis .\
BACKGROUND	It is unknown whether SESIs are an effective addition to usual pain treatment of LRS in general practice .\
BACKGROUND	In our study , we assessed the effectiveness of SESIs on pain and disability as an addition to usual care for acute LRS in general practice .\
METHODS	A pragmatic , single-blinded , randomized controlled trial in Dutch general practice was conducted .\
METHODS	Circumstances of daily practice were closely followed .\
METHODS	Care as usual ( CAU ) was compared to care as usual combined with an additional SESI in 63 patients in the acute phase of LRS .\
METHODS	To detect a minimal clinically important difference of 1.2 points on a numerical rating scale for back pain and a common within-group standard deviation of 1.7 with a two-tailed alpha of 0.05 and a power of 0.80 , we needed 33 subjects in each group .\
METHODS	Statistical analysis was carried out using mixed models .\
RESULTS	A small significant effect in favour of the intervention , corrected for age , sex and baseline values , was found for back pain , impairment and Roland-Morris disability score .\
RESULTS	The differences , though statistically significant , were too small to be considered clinically relevant .\
RESULTS	Patients from the intervention group were significantly more satisfied with the received treatment than patients from the control group .\
CONCLUSIONS	We found a small , statistically significant , but not clinically relevant positive effect of SESIs on back pain , impairment and disability in acute LRS .\
CONCLUSIONS	We do not recommend implementing SESIs as an additional regular treatment option in general practice .\
\
###12932065\
OBJECTIVE	To evaluate the efficacy , delay and duration of analgesia of three equianalgesic epidural doses of levobupivacaine , ropivacaine and bupivacaine during the first stage of labour .\
METHODS	One hundred and twenty-nine healthy primigravida in spontaneous labour who requested epidural analgesia were enrolled in a randomized observer-blinded study .\
METHODS	Parturients were allocated to receive epidural levobupivacaine 0.0625 % , ropivacaine 0.1 % or bupivacaine 0.06259 % .\
METHODS	Sufentanil 10 microg was added to all solutions ; the total volume of epidural solution was 20 mL .\
METHODS	Pain was measured using a 100 mm visual analogue pain scale immediately before the epidural block , and at 5 , 10 , 15 , 20 and 30 min thereafter .\
METHODS	Motor block was evaluated using a modified Bromage scoring system .\
METHODS	The adequacy of motor function for ambulation was also evaluated .\
METHODS	Delay of analgesia was the time interval between the injection of the solution and the first painless contraction .\
METHODS	Duration of analgesia was the time from the first painless contraction to the parturients ' requests for further analgesia .\
RESULTS	Twelve parturients failed to complete the study .\
RESULTS	Eleven parturients had inadequate analgesia ( four in Group Levobupivacaine , four in Group Ropivacaine and three in Group Bupivacaine ; P > 0.05 ) .\
RESULTS	Data was analysed from 34 parturients in Group Levobupivacaine , from 37 in Group Ropivacaine and from 35 in Group Bupivacaine .\
RESULTS	There were no differences in the delay of analgesia or in the number of parturients who were able to walk unaided .\
RESULTS	Levobupivacaine and ropivacaine produced more prolonged analgesia than bupivacaine ( 114 and 119 min , respectively , versus 89 min ; P < 0.01 ) .\
CONCLUSIONS	During early labour , equipotent low concentrations of levobupivacaine , ropivacaine and bupivacaine , all with the addition of sufentanil 10 microg , produced similar pain relief and motor block , but levobupivacaine and ropivacaine produced a longer lasting analgesia .\
CONCLUSIONS	About 10 % of parturients had inadequate analgesia with a single bolus of the tested solutions .\
\
###23636649\
OBJECTIVE	The purposes of this study are to examine ( 1 ) the feasibility and efficacy of two different home-based exercise protocols on the level of physical activity ( PA ) , and ( 2 ) the effect of increased PA via home-based exercise program on biomarkers of colorectal cancer .\
METHODS	Seventeen patients ( age 55.18 13.3 years ) with stage II-III colorectal cancer completed the 12-week home-based exercise program .\
METHODS	Subjects were randomized into either casually intervened home-based exercise group ( CIHE ) or intensely intervened home-based exercise group ( IIHE ) .\
METHODS	The primary outcome was the level of PA. .\
METHODS	Furthermore , insulin , homeostasis model assessment of insulin resistance , insulin-like growth factor axis , and adipocytokines were measured .\
RESULTS	Both CIHE and IIHE program significantly increased the level of PA at 12 weeks compared to its level at baseline ( CIHE , 10.00 8.49 vs. 46.07 45.59 ; IIHE , 12.08 11.04 vs. 35.42 27.42 MET hours per week ) .\
RESULTS	Since there was no difference in PA change between groups ( p = 0.511 ) , the data was combined in analyzing the effects of increased PA on biomarkers .\
RESULTS	Increase in PA significantly reduced insulin ( 6.66 4.58 vs. 4.86 3.48 U/ml , p = 0.006 ) , HOMA-IR ( 1.66 1.23 vs. 1.25 1.04 , p = 0.017 ) , and tumor necrosis alpha - ( TNF - 4.85 7.88 vs. 2.95 5.38 pg/ml , p = 0.004 ) , and significantly increased IGF-1 ( 135.39 60.15 vs. 159.53 ng/ml , p = 0.007 ) , IGF binding protein ( IGFBP ) -3 ( 2.67 1.48 vs. 3.48 1.00 ng/ml , p = 0.013 ) , and adiponectin ( 6.73 3.07 vs. 7.54 3.96 g/ml , p = 0.015 ) .\
CONCLUSIONS	CIHE program was as effective as IIHE program in increasing the level of PA , and the increase in PA resulted in significant change in HOMA-IR , IGF-1 axis , TNF - , and adiponectin levels in stage II-III colorectal cancer survivors .\
\
###18524784\
BACKGROUND	It remains controversial whether the anaesthetic depth as assessed by bispectral index ( BIS ) influences the oculocardiac reflex ( OCR ) during strabismus surgery .\
BACKGROUND	We investigated whether BIS-guided sevoflurane titration may help to optimize the anaesthetic depth for inhibition of the OCR during paediatric strabismus surgery .\
METHODS	Eighty-four patients ( aged 2-12 yr ) undergoing strabismus surgery were randomly allocated to one of the three groups ( n = 28 for each ) according to target BIS value of 40 , 50 , and 60 .\
METHODS	The end-tidal sevoflurane concentration with 50 % N2O/O2 was adjusted towards target BIS .\
METHODS	The incidence of OCR and the lowest heart rate ( HR ) were recorded in relation to the end-tidal sevoflurane concentration .\
RESULTS	The incidence of OCR was higher in Group BIS-60 ( 71.4 % ) than in Groups BIS-40 ( 10.7 % ) ( P < 0.001 ) or BIS-50 ( 32.1 % ) ( P = 0.003 ) , with no difference between Group BIS-40 and Group BIS-50 .\
RESULTS	The lowest HR [ beats min ( -1 ) , mean ( sd ) ] during traction on the extraocular muscle was lower in Group BIS-60 [ 112.3 ( sd 17.8 ) ] compared with Group BIS-40 [ 129.3 ( 11.2 ) ] ( P < 0.001 ) , with no difference between BIS-40 and BIS-50 [ 121.4 ( 16.3 ) ] , and between BIS-50 and BIS-60 .\
RESULTS	The end-tidal sevoflurane concentration was different between the three groups ( P = 0.001 ) .\
CONCLUSIONS	We confirmed that OCR is relevant to the depth of anaesthesia .\
CONCLUSIONS	BIS values of 40-50 seem adequate for the inhibition of OCR .\
CONCLUSIONS	The results suggest that BIS may be a valuable tool during sevoflurane anaesthesia for strabismus surgery in children .\
\
###9502190\
BACKGROUND	Acute hyperglycaemia is known to inhibit jejunal interdigestive motility .\
BACKGROUND	This study was undertaken to establish the effects of hyperglycaemia on fed jejunal motility and small intestinal transit time , and to establish if the effects of hyperglycaemia are mediated in part by hyperinsulinaemia .\
METHODS	Nine healthy male volunteers were studied in random order using three experimental conditions : ( a ) euglycaemic clamp [ glucose 5 mmol L ( -1 ) ] ; ( b ) hyperglycaemic clamp [ glucose 15 mmol L ( -1 ) ] ; and ( c ) euglycaemic hyperinsulinaemic clamp [ glucose 5 mmol L ( - l ) ] .\
METHODS	Fed jejunal motility was induced by an intrajejunal perfusion of lipid ( Lipofundin medium-chained triglyceride 10 % ) at 1.5 mL min ( -1 ) [ 1.5 kcal min ( -1 ) ] for 180 min through the most proximal port of a manometry catheter ( eight ports spaced at 2-cm intervals ) located just distal to the ligament of Treitz .\
METHODS	One minute after starting the lipid perfusion , 15 g of lactulose dissolved in 20 mL of tap water was infused .\
METHODS	Small intestinal transit time was measured by the hydrogen breath test .\
RESULTS	Acute hyperglycaemia reduced the total number of jejunal contractions and progradely propagated contractions , the motility index ( P < 0.05 ) and the mean amplitude of contractions and delayed intestinal transit time .\
RESULTS	Hyperinsulinaemia reduced the total number of jejunal contractions , motility index ( P < 0.05 ) and intestinal transit time .\
CONCLUSIONS	Thus , hyperinsulinaemia may contribute to the inhibitory effects of hyperglycaemia on jejunal motility .\
CONCLUSIONS	In addition , this study demonstrated that intrajejunal infusion of lipid stimulates sustained glucagon-like peptide-1 release .\
CONCLUSIONS	In contrast to fat-induced gastric inhibitory polypeptide release , this glucagon-like peptide-1 release is not inhibited by exogenous or endogenous hyperinsulinaemia ( P = 0.59 ) .\
\
###23034084\
BACKGROUND	Diarrheal diseases and dengue fever are major global health problems .\
BACKGROUND	Where provision of clean water is inadequate , water storage is crucial .\
BACKGROUND	Fecal contamination of stored water is a common source of diarrheal illness , but stored water also provides breeding sites for dengue vector mosquitoes .\
BACKGROUND	Poor household water management and sanitation are therefore potential determinants of both diseases .\
BACKGROUND	Little is known of the role of stored water for the combined risk of diarrhea and dengue , yet a joint role would be important for developing integrated control and management efforts .\
BACKGROUND	Even less is known of the effect of integrating control of these diseases in school settings .\
BACKGROUND	The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools .\
METHODS	This is a 22 factorial cluster randomized controlled trial .\
METHODS	Eligible schools were rural primary schools in La Mesa and Anapoima municipalities , Cundinamarca , Colombia .\
METHODS	Eligible pupils were school children in grades 0 to 5 .\
METHODS	Schools were randomized to one of four study arms : diarrhea interventions ( DIA ) ; dengue interventions ( DEN ) ; combined diarrhea and dengue interventions ( DIADEN ) ; and control ( C ) .\
METHODS	Schools were allocated publicly in each municipality ( strata ) at the start of the trial , obviating the need for allocation concealment .\
METHODS	The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school .\
METHODS	Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm , nine in the DEN , eight in the DIADEN , and nine in the control arms .\
METHODS	The trial status as of June 2012 was : completed baseline data collections ; enrollment , randomization , and allocation of schools .\
METHODS	The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation .\
CONCLUSIONS	This is the first trial investigating the effect of a set of integrated interventions to control both dengue and diarrhea .\
CONCLUSIONS	This is also the first trial to study the combination of diarrhea-dengue disease control in school settings .\
BACKGROUND	Current Controlled Trials ISRCTN40195031 .\
\
###21822077\
OBJECTIVE	Anaesthesia with sevoflurane leads to a high prevalence of emergence agitation in paediatric patients .\
OBJECTIVE	This study investigates the effects of combining hydroxyzine and midazolam on sevoflurane-induced emergence agitation in paediatric patients undergoing infraumbilical surgery with a caudal block .\
METHODS	Eighty-four children 1-7 years of age undergoing general anaesthesia with sevoflurane and caudal block were assigned to two groups .\
METHODS	Children in group M ( n = 42 ) were premedicated with 0.5 mg kg oral midazolam and children in group MH ( n = 42 ) were premedicated with 0.5 mg kg oral midazolam and 1 mg kg hydroxyzine given 30 min before anaesthesia induction .\
METHODS	A caudal epidural block was performed following anaesthesia induction .\
METHODS	Induction quality , parental separation scores and emergence agitation were evaluated .\
METHODS	Emergence agitation was evaluated with the PAED score ( Paediatric Anesthesia Emergence Delirium ) every 5 min during the first 30 min after admission to recovery room .\
METHODS	Induction quality and parental separation were assessed with 4-point scores .\
METHODS	Postoperative pain was evaluated with the 10-point Children 's and Infants ' Postoperative Pain Scale .\
RESULTS	Median parental separation ( 3 vs. 2 ; P = 0.01 ) , induction quality ( 2 vs. 2 ; P = 0.03 ) and sedation scores ( 3 vs. 2 ; P = 0.003 ) were significantly better in the MH group compared to the M group .\
RESULTS	Median PAED score of group M ( 15 ) was higher than that of group MH ( 11 ; P < 0.001 ) and the number of children with PAED scores more than 16 was also higher in group M ( n = 16 ) compared to group MH ( n = 2 ; P < 0.001 ) .\
RESULTS	None of the children had a pain score more than 3 throughout the study period .\
CONCLUSIONS	The incidence of sevoflurane-induced emergence agitation was significantly lower in children premedicated with a midazolam and hydroxyzine combination compared to those premedicated with midazolam only .\
CONCLUSIONS	Furthermore , the midazolam and hydroxyzine combination provided better premedication quality than midazolam alone .\
\
###20464817\
BACKGROUND	Specific inspiratory muscle training ( IMT ) has been shown to significantly attenuate the fall in arterial oxygen saturation ( SpO2 ) during exhaustive exercise while breathing a hypoxic gas mixture of 14 % oxygen .\
BACKGROUND	The aim of the current study was to assess the impact of IMT on resting SpO2 over a range of altitudes in healthy individuals .\
METHODS	Resting SpO2 and the Borg Score were examined at altitudes of 0 or 400 m ( 0-400 m ; 0-1312 .3 ft ) , 1400 m , 4880 m , and 5550 m ( 4593 ft , 16,011 ft , and 18,209 ft ) in 14 military personnel who were part of a climbing expedition to the Nepali Himalaya .\
METHODS	Volunteer participants were randomly assigned to either a control ( N = 7 ) or IMT ( N = 7 ) group : IMT consisted of 1 set of 30 breaths twice daily at 50 % maximal inspiratory mouth pressure ( MIP ) for 4 wk prior to departure .\
RESULTS	MIP was similar between groups pre-IMT but increased significantly by 15 % post-IMT .\
RESULTS	Baseline maximal expiratory mouth pressure was not different between groups .\
RESULTS	The Borg Score increased significantly from 1400 m , but was not different between groups at any altitude .\
RESULTS	Resting SpO2 declined significantly at ascending altitudes in both groups and was similar between groups at altitudes of 0-400 m and 1400 m. However , at altitudes of 4880 m and 5550 m , SpO2 was significantly higher ( 6 % ) in the IMT group .\
CONCLUSIONS	IMT can attenuate the fall in resting SpO2 , but only at altitudes of 4880 m and above .\
CONCLUSIONS	Conversely , IMT had no effect on resting levels of dyspnea as measured by the Borg Score .\
\
###15802109\
OBJECTIVE	To evaluate the effectiveness of self-measurement of blood pressure ( SMBP ) in controlling hypertension .\
METHODS	Randomized , controlled , pragmatic , open study .\
METHODS	The unit of randomization was the basic health care unit ( BCU ) , consisting of 1 physician and 1 nurse .\
METHODS	All BCUs were randomized to the control group ( usual clinical practice , n = 94 ) or to the intervention group ( n = 86 ) .\
METHODS	Primary care BCUs throughout Spain .\
METHODS	Patients with poorly controlled essential hypertension , defined as systolic blood pressure > or = 140 or diastolic blood pressure > or = 90 mm Hg .\
METHODS	The patients were given an OMRON HEM-705CP automatic blood pressure monitor on two occasions , for use during 15 days at weeks 6 and 14 .\
METHODS	Blood pressure was recorded at each visit ( baseline , 6 , 8 , 14 , 16 , and 24 weeks ) .\
METHODS	Main outcome measures .\
METHODS	control of blood pressure , considered systolic/diastolic blood pressure < 140/90 mm Hg ( 130/85 in patients with diabetes ) .\
RESULTS	180 BCUs serving 1325 patients ( 622 in the intervention group , 703 in the control group ) participated .\
RESULTS	Baseline characteristics were similar in both groups .\
RESULTS	Immediately after the first period of SMBP ( week 8 ) the proportion of patients whose blood pressure was well controlled was 7.6 % higher in the intervention group than in the control group ( P = .01 ) .\
RESULTS	After the second period of SMBP ( week 16 ) the difference between groups decreased to 4.1 % ( P = .27 ) .\
RESULTS	At the end of the study the difference was 4.9 % ( P = .19 ) .\
CONCLUSIONS	Self-measurement of blood pressure was effective in controlling blood pressure in the short term , but its effects faded over time .\
\
###16398424\
OBJECTIVE	To assess the effects of early intestinal application of sijunzi decoction ( SJZD ) on the immune function in post-operational patients of gastrointestinal tumor .\
METHODS	Ninety-two patients with malignant gastrointestinal tumor were randomly divided into two groups .\
METHODS	Patients in both groups were given the isocaloric and isonitrogenous enteral nutritional support starting from the first day after operation for 1 week , but to the tested group , SJZD was given additionally .\
METHODS	The concentration of serum cytokines such as interleukin-1 ( IL-1 ) , interleukin-2 ( IL-2 ) , interleukin-6 ( IL-6 ) and tumor necrosis factor-alpha ( TNF-alpha ) , the peripheral blood cell counts of total lymphocyte , T-lymphocyte , B lymphocyte , and T lymphocyte subsets ( CD3 , CD4 , CD8 , CD4/CD8 ) as well as the levels of IgA , IgG , IGM and C-reactive protein ( CRP ) were measured on the day before operation , the first morning after operation and at the end of study .\
RESULTS	At the end of the study , the concentration of IgA , IgG , 1gM , number of total lymphocyte , CD3 , CD4 and CD4 lCD8 , and serum IL-2 were obviously higher ( P < 0.05 ) , and levels of IL-6 , TNF-alpha and CRP were obviously lower in the tested group than those in the control group ( P < 0.05 ) .\
CONCLUSIONS	Early application of SJZD on the base of enteral nutritional therapy can lessen the degree of post-operational stress and inflammatory response , and enhance the immune function of patients .\
\
###24285128\
OBJECTIVE	The aim of our study was to evaluate renal function assessed by serum creatinine as well as novel biomarkers in 142 patients with stable coronary heart disease and normal serum creatinine undergoing percutaneous coronary interventions ( PCI ) depending on the type of hydration : physiological saline vs. sodium bicarbonate ( 1:1 randomization ) .\
METHODS	Serum and urinary NGAL were evaluated before and after 8-12 , and 24 hours after PCI .\
METHODS	Serum cystatin C , serum creatinine , estimated glomerular filtration rate using different formulae were assessed before PCI , and 24 hours after the procedure .\
RESULTS	Only 2 patients ( 2.8 % ) from the saline-hydrated group fulfilled the criteria for CI-AKI .\
RESULTS	In patients hydrated with sodium bicarbonate serum creatinine declined significantly ( p < 0.01 ) .\
RESULTS	In patients hydrated with sodium bicarbonate a significant fall in serum NGAL after 8-12 hours was found .\
RESULTS	In sodium bicarbonate group cystatin C decreased non significantly after 8-12 hours , then returned to the baseline values .\
RESULTS	In patients hydrated with physiological saline serum NGAL before PCI and after 24 hours correlated positively with cystatin C and eGFR by CKD-EPI .\
RESULTS	In patients hydrated with sodium bicarbonate baseline serum NGAL correlated with NGAL baseline cystatin C and eGFR by CKD-EPI , similarly serum NGAL after 24 hours correlated with cystatin C.\
CONCLUSIONS	We suggest to rather use sodium bicarbonate in a hydration protocol in patients undergoing PCI .\
CONCLUSIONS	However , the value of NGAL in this setting remains to be elucidated and volume expansion remain the unquestionable prevention methods of CI-AKI .\
\
###23574290\
OBJECTIVE	To evaluate the effects of self-relaxation training on sleep quality and cognitive functions in the older .\
BACKGROUND	Ageing causes declines in sleep quality and cognitive functions in older adults , and decreased sleep quality also accelerates declines in cognitive functions .\
BACKGROUND	Therefore , it is necessary to find cost-effective interventions to enhance sleep quality in the older , thereby improving their cognitive functions or delaying cognitive decline .\
METHODS	Randomised controlled study .\
METHODS	The study was conducted between July 2010 and June 2011 at Wangyuehu Community in Changsha , China .\
METHODS	Eighty older adults with reduced sleep quality were selected and randomly assigned to experimental ( n = 40 ) or control ( n = 40 ) group .\
METHODS	Subjects in the experimental group received self-relaxation training including progressive muscle relaxation and meditation based on sleep hygiene education , while the control group received sleep hygiene education only .\
METHODS	Sleep quality and cognitive functions of the two groups were measured prior to training and at the end of the 3rd , 6th and 12th months using four reliable and valid questionnaires .\
RESULTS	Repeated measures anova revealed that the self-relaxation training had significant main effect as well as interaction effect with time on sleep quality and cognitive functions .\
RESULTS	Except for scores of Epworth Sleepiness Scale , Mini-Mental State Examination and number memory , time had significant main effect on scores of Pittsburgh Sleep Quality Index , picture memory , associative memory and understanding memory .\
CONCLUSIONS	Self-relaxation training can improve sleep quality and cognitive functions in the older .\
CONCLUSIONS	Self-relaxation training is a non-invasive , simple and inexpensive therapeutic method of improving sleep quality and cognitive functions in community-dwelling older people .\
\
###18583187\
BACKGROUND	Mandibular advancement appliances ( MAA ) are a recognized alternative treatment to continuous positive airway pressure ( CPAP ) for mild-moderate obstructive sleep apnea syndrome ( OSAS ) .\
BACKGROUND	The aim of this study is to assess the efficacy of and subject satisfaction with two MAA in the management of OSAS .\
METHODS	Five women and 11 men ( 47.9 + / -1.6 years ) , previously untreated with CPAP , were recruited from a sleep disorders clinic following a polysomnographic diagnosis of mild-moderate OSAS with Respiratory Disturbance Index ( RDI ) of 9.4 + / -1.1 .\
METHODS	A randomized single blind cross-over study was completed with both Klearway and Silencer ( three months for each study arm ) .\
METHODS	Subjects completed standardized questionnaires on sleep quality , sleepiness and functional outcomes ( Functional Outcome Sleep Questionnaire : FOSQ ) .\
METHODS	MAA satisfaction ( e.g. , comfort ) and efficacy ( e.g. , reduction of respiratory noises , headache ) were assessed by subjects and sleep partner .\
RESULTS	The two MAA ( Silencer 4.7 + / -0.9 and Klearway 6.5 + / -1.3 ) significantly reduced the RDI compared to the baseline night ( 10.0 + / -1.2 , respectively p < 0.001 and p < 0.01 ) .\
RESULTS	The RDI was slightly lower with the Silencer ( p0 .05 ) but subjects ' preference for comfort was in favor of the Klearway ( Klearway 7.0 + / -0.4 vs Silencer 5.8 + / -0.4 , p = 0.04 ) .\
RESULTS	The Epworth score , FOSQ , respiratory noise and morning headache were also improved following use of both appliances ( p0 .05 to 0.001 ) .\
CONCLUSIONS	Although both MAA decreased RDI and subjective daytime sleepiness in a similar manner , the choice between various types of MAA needs to be taken into account when considering the benefit of RDI reduction over the benefit of subject compliance .\
CONCLUSIONS	The long term benefit of increased RDI reduction vs. a better subject compliance needs to be assessed in prospective studies .\
\
###21127282\
BACKGROUND	Although sedation is often performed during spinal anesthesia , the details of intraoperative dreaming have not been reported .\
BACKGROUND	We designed this prospective study to compare 2 different IV sedation protocols ( propofol and midazolam infusion ) with respect to dreaming during sedation .\
METHODS	Two hundred twenty adult patients were randomly assigned to 2 groups and received IV infusion of propofol or midazolam for deep sedation during spinal anesthesia .\
METHODS	Patients were interviewed on emergence and 30 minutes later to determine the incidence , content , and nature of their dreams .\
METHODS	Postoperatively , patient satisfaction with the sedation was also evaluated .\
RESULTS	Two hundred fifteen patients ( 108 and 107 in the propofol and midazolam groups , respectively ) were included in the final analysis .\
RESULTS	The proportion of dreamers was 39.8 % ( 43/108 ) in the propofol group and 12.1 % ( 13/107 ) in the midazolam group ( odds ratio = 4.78 ; 95 % confidence interval : 2.38 to 9.60 ) .\
RESULTS	Dreams of the patients receiving propofol were more memorable and visually vivid than were those of the patients receiving midazolam infusion .\
RESULTS	The majority of dreams ( 36 of 56 dreamers , 64.3 % ) were simple , pleasant ruminations about everyday life .\
RESULTS	A similarly high level of satisfaction with the sedation was observed in both groups .\
CONCLUSIONS	In cases of spinal anesthesia with deep sedation , dreaming was almost 5 times more common in patients receiving propofol infusion than in those receiving midazolam , although this did not influence satisfaction with the sedation .\
CONCLUSIONS	Thus , one does not need to consider intraoperative dreaming when choosing propofol or midazolam as a sedative drug in patients undergoing spinal anesthesia .\
\
###15711607\
OBJECTIVE	To evaluate the efficacy of bicalutamide vs cyproterone acetate in preventing PSA flare ( as a surrogate for tumour flare ) for patients requiring luteinizing hormone-releasing hormone ( LHRH ) analogue therapy for prostate cancer .\
METHODS	In this pilot study , 40 men were randomized 1 : 1 to bicalutamide 50 mg o.d. or cyproterone acetate 100 mg t.i.d. 5 days prior to goserelin acetate and continued for 21 days thereafter .\
METHODS	PSA , luteinizing hormone ( LH ) , follicle-stimulating hormone ( FSH ) and testosterone were obtained before treatment and on days 6 , 8 , 10 , 16 , 21 and 28 .\
METHODS	Primary end point was PSA .\
METHODS	Hormone profile and clinical features including urinary symptoms and bone pain were secondary end points .\
RESULTS	Both groups were equally matched apart from serum creatinine and ALP .\
RESULTS	The speed and magnitude of the percentage change in median PSA from baseline was increased for the CPA group but there was no statistically significant difference in the two groups .\
RESULTS	Although those receiving bicalutamide all showed a testosterone peak , this remained within the normal range .\
RESULTS	No difference in the frequency of drug-specific adverse events was found .\
RESULTS	None of the patients died or developed cord compression during the study period .\
CONCLUSIONS	Bicalutamide is able to suppress the initial PSA surge as effectively as cyproterone acetate albeit slightly delayed .\
CONCLUSIONS	A statement whether bicalutamide is equally good at preventing clinical flare can not be made and should be assessed in an appropriately powered study .\
\
###17631702\
OBJECTIVE	To evaluate influence of recombinant human growth hormone ( rhGH ) on nutritional status and immune function in early postoperative stage of liver transplantation including hepatic function , acute rejection and infection rate , in order to assess its safety in clinical use .\
METHODS	Sixty patients with non-malignant diseases of the liver in terminal stages were randomly divided into two groups : treatment group ( rhGH treatment n = 30 ) and control group ( n = 30 ) .\
METHODS	All the patients received the same nutritional support and immunodepressant treatment regimes .\
METHODS	The patients in treatment group received rhGH 10 U hypodermically daily for 10 days 24 hours after liver transplantation .\
METHODS	The following parameters including siderophilin , prealbumin , albumin , urea nitrogen , CD4/CD8 , immunoglobulin G ( IgG ) , IgM , IgA , growth hormone ( GH ) , insulin-like growth factor-1 ( IGF-1 ) , aspartate aminotransferase ( AST ) , alanine aminotransferase ( ALT ) , dosage of insulin to control blood sugar ( 8-10 mmol/L ) were determined on 1st , 4th , 8th , 14th days after the operation , and acute rejection rate after 28 days of operation ( confirmed by liver acupuncture biopsy ) , and infection rate were also assessed .\
RESULTS	Compared with control group , levels of siderophilin , prealbumin , CD4/CD8 , GH , IGF-1 within 14 days in treatment group were increased significantly 14 days after the operation ( all P < 0.05 ) , and level of urea nitrogen was decreased significantly ( P < 0.05 ) .\
RESULTS	The level of albumin in treatment group was lower than that in control group 14 days after operation ( P < 0.05 ) , while dosages of exogenous insulin were higher on 4th and 8th days after operation than that in control group ( both P < 0.05 ) .\
RESULTS	There were no significant differences in levels of AST , ALT within 14 days , or acute rejection rate and infection rate within 28 days between two groups ( all P > 0.05 ) .\
CONCLUSIONS	rhGH can accelerate recovery of nutritional status in the early liver transplantation period .\
CONCLUSIONS	It does not show superiority in improving immune function and influence on recovery of hepatic function , acute rejection or infection rate .\
CONCLUSIONS	The safety has been challenged by inducing high blood sugar as a side effect .\
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###14657693\
BACKGROUND	Reduced bone mineral density ( BMD ) is common in long-term renal transplant recipients and results in a high incidence of fractures .\
BACKGROUND	The optimal therapy for these patients is not known .\
METHODS	Baseline BMD determinations were obtained in 211 long-term adult renal transplant recipients .\
METHODS	One hundred and seventeen patients with a reduced BMD ( T score < or = -1 ) were randomly assigned to treatment with alendronate and calcium ( n = 60 ) versus calcitriol and calcium ( n = 57 ) .\
METHODS	Of these , 46 and 51 patients , respectively , completed 1 year of treatment .\
METHODS	Forty-nine patients who were not eligible or did not consent to the trial were followed prospectively .\
RESULTS	Reduced baseline BMD ( T score < or = -1 ) was present in 159 ( 78.7 % ) of patients at the lumbar spine or femur .\
RESULTS	There was no significant loss of BMD in the prospectively followed patients during 2.7 years .\
RESULTS	The average lumbar BMD increased from 0.984 + / -0.149 to 1.025 + / -0.143 g/cm2 ( P < 0.001 ) with alendronate and from 1.014 + / -0.15 to 1.034 + / -0.146 g/cm2 ( P = 0.002 ) with calcitriol .\
RESULTS	BMD at the femur increased from 0.809 + / -0.092 to 0.836 + / -0.107 g/cm2 ( P < 0.001 ) with alendronate and from 0.830 + / -0.144 to 0.857 + / -0.125 g/cm2 ( P = 0.023 ) with calcitriol .\
CONCLUSIONS	One year of treatment with alendronate or calcitriol , both with calcium supplementation , resulted in significant increases in BMD at the lumbar spine and femur , with a trend toward alendronate being more effective at the spine ( P = 0.082 ) .\
CONCLUSIONS	Further studies are needed to determine whether BMDs continue to increase after 1 year and whether there is any additional benefit to combining vitamin D and alendronate .\
CONCLUSIONS	Larger studies are needed to determine whether treatment decreases fracture rates .\
\
###7779130\
OBJECTIVE	To compare the efficacy and safety of tiludronate and etidronate at the same dosage ( 400 mg/day ) for the treatment of active Paget 's disease of bone .\
METHODS	We studied 234 patients with radiologic lesions characteristic of Paget 's disease of bone and serum alkaline phosphatase ( AP ) concentrations at least twice the upper limit of normal , in a prospective , randomized , double-blind , multicenter clinical trial lasting 6 months .\
METHODS	Patients were randomly allocated into 1 of 3 treatment groups : tiludronate for 3 months followed by placebo for 3 months , tiludronate for 6 months , or etidronate for 6 months .\
METHODS	Serum AP levels and urinary hydroxyproline excretion were measured at baseline and after 3 months and 6 months .\
METHODS	Patients with a reduction of at least 50 % in the serum AP concentration were considered to be responders .\
RESULTS	After 3 months , the proportion of responders was higher in the tiludronate group ( 57.4 % ) than in the etidronate group ( 13.9 % ) ( P < 0.0001 ) .\
RESULTS	In the etidronate group , this percentage was lower among patients who had received previous treatment with a bisphosphonate ( 2.3 % ) than among those who had not ( 28.6 % ) ( P < 0.01 ) .\
RESULTS	Previous bisphosphonate treatment was not associated with response in the tiludronate group .\
RESULTS	After 6 months , the proportion of responders did not differ between the 2 tiludronate groups ( 60.3 % and 70.1 % ) , but was lower in the etidronate group ( 25.3 % ) ( P < 0.0001 ) .\
RESULTS	There was a higher proportion of patients with treatment-resistant disease ( < 25 % reduction of serum AP ) in the etidronate group ( 51.9 % ) than in the tiludronate 3-month group ( 17.9 % ) or the tiludronate 6-month group ( 19.5 % ) ( P < 0.0001 ) .\
RESULTS	Gastrointestinal disturbances were more common , and occurred earlier , with tiludronate , but they were mostly mild , requiring no treatment .\
CONCLUSIONS	Tiludronate at 400 mg/day for 3 months or 6 months is more effective than the same dosage of etidronate for 6 months in the treatment of Paget 's disease .\
\
###15105028\
OBJECTIVE	We investigated whether postexercise consumption of a supplement containing whey protein , amino acids , creatine , and carbohydrate combined with a strength training program promotes greater gains in fat-free mass ( FFM ) , muscle strength and endurance , and anaerobic performance compared with an isocaloric , carbohydrate-only control drink combined with strength training .\
METHODS	The study was double blind and randomized , and the experimental supplement was compared with a carbohydrate-only control .\
METHODS	Forty-one males ( n = 20 in control group , n = 21 in the supplement group ; mean age , 22.2 y ) participated in a 4 d/wk , 10-wk periodized strength training program .\
METHODS	Subjects had to complete at least 70 % of the workouts .\
METHODS	Before and after 10 wk of strength training , subjects were tested for body composition by using hydrostatic weighing and skinfold thicknesses , one repetition maximum strength and muscular endurance for the bench press and 45-degree leg press , and anaerobic performance using a 30-s Wingate test .\
METHODS	Thirty-three subjects ( 80.5 % ) completed the training program ( n = 15 in control group , n = 18 in the supplement ) ; these 33 subjects also completed all post-training test procedures .\
METHODS	Data were analyzed with two-way analysis of variance with repeated measures on time .\
METHODS	P < == 0.05 was set as statistically significant .\
METHODS	All statistical analyses , including calculation of effect size and power , were completed with SPSS 11.0 .\
RESULTS	Across groups , FFM increased during 10 wk of strength training .\
RESULTS	Although there was no statistically significant time x group interaction for FFM , there was a trend toward a greater increase in FFM for the supplement group ( +3.4 kg ) compared with the control group ( +1.5 kg ; P = 0.077 ) .\
RESULTS	The effect size ( eta ( 2 ) = 0.100 ) was moderately large .\
RESULTS	Percentage of body fat declined and fat mass was unchanged ; there were no differences between groups .\
RESULTS	One repetition maximum strength for the bench press and 45-degree leg press increased , but there were no differences between groups .\
RESULTS	Muscular endurance expressed as the number of repetitions completed with 85 % of the one repetition maximum was unchanged ; external work , which was estimated as repetitions completed x resistance used , increased for the 45-degree leg press but not for the bench press over the 10-wk training period ; there were no time x group interactions for either measurement .\
RESULTS	Anaerobic power and capacity improved , but there were no differences between groups for these variables or for fatigue rate .\
CONCLUSIONS	Consumption of a recovery drink after strength training workouts did not promote greater gains in FFM compared with consumption of a carbohydrate-only drink ; however , a trend toward a greater increase in FFM in the supplement group suggests the need for longer-term studies .\
CONCLUSIONS	Performance variables such as muscle strength and endurance and anaerobic performance were not improved when compared with the carbohydrate-only group .\
\
###22006202\
OBJECTIVE	To compare the efficacy , safety , and tolerability of 6 dosages of oral tofacitinib ( CP-690 ,550 ) with placebo for the treatment of active rheumatoid arthritis ( RA ) in patients receiving a stable background regimen of methotrexate ( MTX ) who have an inadequate response to MTX monotherapy .\
METHODS	In this 24-week , double-blind , phase IIb study , patients with active RA ( n = 507 ) were randomized to receive placebo or tofacitinib ( 20 mg/day , 1 mg twice daily , 3 mg twice daily , 5 mg twice daily , 10 mg twice daily , or 15 mg twice daily ) .\
METHODS	All patients continued to receive a stable dosage of MTX .\
METHODS	The primary end point was the American College of Rheumatology 20 % improvement criteria ( ACR20 ) response rate at week 12 .\
RESULTS	At week 12 , ACR20 response rates for patients receiving all tofacitinib dosages 3 mg twice daily ( 52.9 % for 3 mg twice daily , 50.7 % for 5 mg twice daily , 58.1 % for 10 mg twice daily , 56.0 % for 15 mg twice daily , and 53.8 % for 20 mg/day ) were significantly ( P 0.05 ) greater than those for placebo ( 33.3 % ) .\
RESULTS	Improvements were sustained at week 24 for the ACR20 , ACR50 , and ACR70 responses , scores for the Health Assessment Questionnaire disability index , the 3-variable Disease Activity Score in 28 joints using the C-reactive protein level ( DAS28-CRP ) , and a 3-variable DAS28-CRP of < 2.6 .\
RESULTS	The most common treatment-emergent adverse events occurring in > 10 % of patients in any tofacitinib group were diarrhea , upper respiratory tract infection , and headache ; 21 patients ( 4.1 % ) experienced serious adverse events .\
RESULTS	Sporadic increases in transaminase levels , increases in cholesterol and serum creatinine levels , and decreases in neutrophil and hemoglobin levels were observed .\
CONCLUSIONS	In patients with active RA in whom the response to MTX has been inadequate , the addition of tofacitinib at a dosage 3 mg twice daily showed sustained efficacy and a manageable safety profile over 24 weeks .\
\
###15064595\
OBJECTIVE	The number of youth that meet activity guidelines is decreasing and easy access to reinforcing sedentary behaviors competes with increasing physical activity .\
OBJECTIVE	In the laboratory , open-loop feedback that used pedometer activity counts to gain access to sedentary alternatives doubled physical activity .\
OBJECTIVE	This study evaluated the influence of open-loop feedback and reinforcement on physical activity and television ( TV ) time in a small clinical trial .\
METHODS	Children ( 8-12 yr old ) were randomized to an open-loop feedback plus reinforcement intervention ( N = 11 ) or no feedback , no reinforcement control ( N = 7 ) .\
METHODS	Subjects wore an accelerometer for 6 wk and attended meetings to download the accelerometer .\
METHODS	Accumulating physical activity counts gave subjects in the open-loop group access to TV time , controlled by a TV Allowance device , with 400 counts = 1 h of TV .\
METHODS	The control group had no feedback for activity and free access to TV .\
RESULTS	The open-loop group had a 24 % increase in physical activity , which was greater ( P = 0.02 ) than the control group .\
RESULTS	TV time of the open-loop group was reduced by 18 % or 20 min x d ( -1 ) whereas the control group increased by 13 min x d ( -1 ) , but these were not significant changes .\
RESULTS	The change in time spent watching television was directly related to the change in BMI z-score ( r = 0.69 , P = 0.002 ) .\
CONCLUSIONS	Open-loop feedback increases physical activity in children , thus helping children to achieve physical activity recommendations .\
CONCLUSIONS	Reductions in TV watching may reduce or minimize gains in body weight .\
\
###7644452\
BACKGROUND	This study quantifies resources used to conduct 26 community-wide quit-smoking contests , the percentage of smokers that participated in these contests , and the statistical associations between resource inputs and participation percentages .\
METHODS	Data collected from the 11 COMMIT intervention communities ( adult population range 47,490-185 ,913 ) included number of contest participants , contest procedures , and resource inputs .\
METHODS	Stepwise regression was used to find the most meaningful association ( s ) of independent variables with contest participation percentage .\
RESULTS	Contest participation percentages ranged from 0.27 to 3.11 % of smokers ( mean = 1.26 % ) .\
RESULTS	Total cost ( COMMIT and community-contributed resources and dollar expenditures ) to conduct a contest averaged $ 24,857 ( range $ 5,751 - $ 74,556 ) , or $ 78.57 per contest participant .\
RESULTS	Expenditures in various specific resource categories varied greatly .\
RESULTS	Total expenditures per smoker in the community ( excluding expenditures for prizes ) was the independent variable most highly correlated with contest participation percentage , accounting for 63 % of the total variability in participation percentages .\
CONCLUSIONS	The percentage of smoker participation in community-wide stop-smoking contests appears primarily to be a function of total resource expenditures , regardless of the specific types of resources funded .\
CONCLUSIONS	Stop-smoking contests are judged to be quite cost effective .\
CONCLUSIONS	Study strengths and weaknesses are discussed .\
\
###24135530\
OBJECTIVE	MCI-186 ( edaravone ) is a free radical scavenger approved in Japan since 2001 for the treatment of patients with acute ischemic stroke within 24 h from the onset of symptoms .\
OBJECTIVE	It was recommended by the Japanese Guidelines for the Management of Stroke 2004 .\
OBJECTIVE	Our aim was to investigate the safety , tolerability and pharmacokinetics of a new formulation and dose regimen ( intravenous bolus plus infusion ) of MCI-186 suitable for the treatment of acute ischemic stroke in Europe because the Japanese treatment protocol includes twice-a-day intravenous infusion of MCI-186 for a maximum of 14 days .\
OBJECTIVE	Such a treatment protocol is not very practical in Europe , where hospital stay is much shorter in acute hospitals .\
METHODS	In a double-blind , placebo-controlled randomized clinical trial we studied two dosing regimens , each in a cohort of 18 patients .\
METHODS	Patients were randomized in a 2:1 ratio in both cohorts to receive MCI-186 or placebo .\
METHODS	Review of safety and plasma concentration data from the first cohort ( loading dose 0.08 mg/kg + 0.2 mg/kg/h infusion ) preceded the second cohort ( loading dose 0.16 mg/kg + 0.4 mg/kg/h infusion ) .\
METHODS	Safety parameters included adverse events , severe adverse events , physical examinations , local reactions at infusion site , ECG , clinical chemistry and hematology , modified Total Neuropathy Score and CT scans .\
RESULTS	Mean age and National Institutes of Health Stroke Scale ( NIHSS ) score on admission of patients in cohorts 1 and 2 and the placebo group were 64 , 63 , and 69 years and 5 , 5 , and 6 , respectively .\
RESULTS	The number of treatment emergent adverse events that occurred was 109 , most of which were transient , mild or moderate .\
RESULTS	Both doses of the new formulation and dosing regimen were well tolerated .\
RESULTS	After the initiation of the infusion , plasma concentrations of MCI-186 reached or exceeded prespecified target levels within 24 h in both MCI-186 cohorts , which were in the putative therapeutic range in humans .\
RESULTS	Geometric mean values of MCI-186 plasma concentration at the end of the infusion in cohorts 1 and 2 were 391 and 1,595 ng/ml , respectively .\
CONCLUSIONS	The primary objective of the present study , safety and tolerability of the new formulation and dosing regimen , was achieved .\
CONCLUSIONS	The new formula and both dosing regimens were well tolerated and achieved intended plasma concentrations suitable for larger safety studies before pivotal trials .\
\
###14739186\
OBJECTIVE	To compare the effectiveness of an electrocautery strategy with ovulation induction using recombinant follicle stimulating hormone in patients with polycystic ovary syndrome .\
METHODS	Randomised controlled trial .\
METHODS	Secondary and tertiary hospitals in the Netherlands .\
METHODS	168 patients with clomiphene citrate resistant polycystic ovary syndrome : 83 were allocated electrocautery and 85 were allocated recombinant follicle stimulating hormone .\
METHODS	Laparoscopic electrocautery of the ovaries followed by clomiphene citrate and recombinant follicle stimulating hormone if anovulation persisted , or induction of ovulation with recombinant follicle stimulating hormone .\
METHODS	Ongoing pregnancy within 12 months .\
RESULTS	The cumulative rate of ongoing pregnancy after recombinant follicle stimulating hormone was 67 % .\
RESULTS	With only electrocautery it was 34 % , which increased to 49 % after clomiphene citrate was given .\
RESULTS	Subsequent recombinant follicle stimulating hormone increased the rate to 67 % at 12 months ( rate ratio 1.01 , 95 % confidence interval 0.81 to 1.24 ) .\
RESULTS	No complications occurred from electrocautery with or without clomiphene citrate .\
RESULTS	Patients allocated to electrocautery had a significantly lower risk of multiple pregnancy ( 0.11 , 0.01 to 0.86 ) .\
CONCLUSIONS	The ongoing pregnancy rate from ovulation induction with laparoscopic electrocautery followed by clomiphene citrate and recombinant follicle stimulating hormone if anovulation persisted , or recombinant follicle stimulating hormone , seems equivalent to ovulation induction with recombinant follicle stimulating hormone , but the former procedure carries a lower risk of multiple pregnancy .\
\
###23417765\
OBJECTIVE	The aim of the study was to better understand blonanserin population pharmacokinetic ( PK ) characteristics in Chinese healthy subjects .\
METHODS	Data from two studies with 50 subjects were analyzed to investigate the population PK characteristics of blonanserin at single dose ( 4 , 8 , and 12 mg ) under fasting , multidose ( 4 mg bid or 8 mg qd for 7 days ) and under food intake condition ( single dose , 8 mg ) .\
METHODS	Blonanserin plasma concentrations were detected using the high performance liquid chromatography tandem mass spectrometry ( LC/MS/MS ) .\
METHODS	A nonlinear mixed-effects model was developed to describe the blonanserin concentration-time profiles .\
RESULTS	A two compartment model with first-order absorption was built to describe the time-course of blonanserin .\
RESULTS	The population-predicted system apparent clearance ( CL/F ) , volume of apparent distribution in center ( V ( 1 ) / F ) , and the first-order absorption rate constant ( Ka ) of blonanserin under fasting was 1230L/h , 9500L , and 3.02 h ( -1 ) , respectively .\
RESULTS	Food intake decreased Ka of blonanserin to 0.78 h ( -1 ) .\
RESULTS	The relative bioavailability between fasting and food intake estimated by the final model was 55 % .\
RESULTS	No clinically significant safety issues were identified .\
CONCLUSIONS	This is the first study assessing the PK profile of blonanserin with population PKs method .\
CONCLUSIONS	The results can be used for simulation in further clinical trial and optimize individual dosage regimens using a Bayesian methodology in patients .\
\
###9323747\
OBJECTIVE	The study evaluated the relative impact of HIV risk reduction interventions for adults with severe mental illness living in the inner city .\
METHODS	A total of 104 chronically mentally ill men and women were interviewed to determine sexual risk behavior over the past month and to assess HIV risk-related psychological characteristics , including their knowledge about risk behavior , their belief in their ability to change their behavior , their perceptions of peer and social norms about safer sex , their expectancies about the outcomes of these changes , and their perceived barriers to condom use .\
METHODS	Participants were then randomly assigned to one of three conditions : a single AIDS education session , a seven-session cognitive-behavioral HIV risk reduction group intervention , or a seven-session group intervention that combined the cognitive-behavioral intervention with training to act as a risk reduction advocate to friends ( advocacy training ) .\
METHODS	Individuals were reinterviewed three months after completion of the intervention .\
RESULTS	Although all participants exhibited change at follow-up in some risk-related psychological characteristics and sexual risk behaviors , participants who received the cognitive-behavioral intervention that included the advocacy training reported greater reductions in rates of unprotected sex and had fewer sexual partners at follow-up .\
CONCLUSIONS	HIV prevention interventions that teach risk reduction skills and then encourage participants to advocate behavior change to others appear to strengthen participants ' capacity to change their behavior to reduce HIV risk , even those from a disenfranchised group such as severely mentally ill adults .\
\
###16884050\
OBJECTIVE	This study examined the way in which the type and preexisting strength of association between an auditory icon and a warning event affects the ease with which the icon/event pairing can be learned and retained .\
BACKGROUND	To be effective , an auditory warning must be audible , identifiable , interpretable , and heeded .\
BACKGROUND	Warnings consisting of familiar environmental sounds , or auditory icons , have potential to facilitate identification and interpretation .\
BACKGROUND	The ease with which pairings between auditory icons and warning events can be learned and retained is likely to depend on the type and strength of the preexisting icon/event association .\
METHODS	Sixty-three participants each learned eight auditory-icon/denotative-referent pairings and attempted to recall them 4 weeks later .\
METHODS	Three icon/denotative-referent association types ( direct , related , and unrelated ) were employed .\
METHODS	Participants rated the strength of the association for each pairing on a 7-point scale .\
RESULTS	The number of errors made while learning pairings was greater for unrelated than for either related or direct associations , whereas the number of errors made while attempting to recall pairings 4 weeks later was greater for unrelated than for related associations and for related than for direct associations .\
RESULTS	Irrespective of association type , both learning and retention performance remained at very high levels , provided the strength of the association was rated greater than 5 .\
CONCLUSIONS	This suggests that strong preexisting associations are used to facilitate learning and retention of icon/denotative-referent pairings .\
CONCLUSIONS	The practical implication of this study is that auditory icons having either direct or strong , indirect associations with warning events should be preferred .\
\
###9756250\
OBJECTIVE	To evaluate the effects of a completely soluble fiber on fasting and postprandial hormone levels , respiratory quotient ( RQ ) and subjective ratings of satiety during a controlled weight-loss program .\
METHODS	In a five-week prospective , randomized , double-blind study , a 3.3 MJ ( 800 kcal ) / d diet was provided during a two-week wash-in period .\
METHODS	Then , during the intervention weeks , separated by a one-week wash-out period , a 3.3 MJ ( 800 kcal ) formula containing either 20 g fiber or placebo daily , was given in a cross-over design and on days 1 , 3 and 7 of the intervention weeks ( weeks 3 and 5 ) measurements were taken after an overnight fast .\
METHODS	25 obese but otherwise healthy females ( age : 46 + / -6 y , body mass index ( BMI ) : 35 + / -6 kg/m2 ) were studied .\
METHODS	Body weight ; hunger/satiety ratings ; glucose , insulin , cholecystokinin ( CCK ) and leptin concentrations ; RQ during the intervention weeks .\
RESULTS	In the fasting state , the supplement had no effect on any of the measured parameters , including blood concentrations of glucose , insulin , CCK , and leptin , RQ and satiety ratings .\
RESULTS	In the 2 h postprandial period following the test meal , none of the measured parameters differed significantly from that following the non-fiber-supplemented meal , except for the CCK response .\
RESULTS	CCK demonstrated an overall higher concentration after the fiber-supplemented meal ( P = 0.007 ) , even after adjustment for age , weight , height and treatment sequence .\
RESULTS	The postprandial peak in CCK also occurred earlier ( at 15 min vs 30 min ) after completion of the fiber-supplemented meal .\
CONCLUSIONS	The results indicated that a hydrolyzed guar gum fiber supplement produced a heightened postprandial CCK response , but did not alter other satiety hormones or increase satiety ratings , in either the fasting or the postprandial state .\
\
###18359360\
OBJECTIVE	To evaluate efficacy and safety of memantine in the treatment of tinnitus .\
METHODS	Prospective , randomized , double-blind crossover study .\
METHODS	A total of 60 patients with tinnitus were randomized into a double-blind , placebo-controlled , prospective crossover study .\
METHODS	Patients each received up to 20 mg memantine and placebo for 90 days , separated by a 30-day washout period .\
METHODS	Treatment effects were assessed by using the Tinnitus Handicap Inventory ( THI ) .\
METHODS	A total of 43 patients completed the trial .\
RESULTS	There was no significant improvement of THI score after memantine treatment compared with placebo .\
RESULTS	A possible tendency for delayed effects of memantine was observed .\
RESULTS	The incidence of side effects during memantine treatment was 9.4 percent , leading to interruption of treatment in all cases .\
CONCLUSIONS	This study does not provide evidence to recommend memantine for the treatment of tinnitus .\
CONCLUSIONS	A possible late effect of the drug should be evaluated in further studies with longer observation periods .\
\
###25002002\
BACKGROUND	Advances in information technology ( IT ) now permit population-based preventive screening , but the best methods remain uncertain .\
BACKGROUND	We evaluated whether involving primary care providers ( PCPs ) in a visit-independent population management IT application led to more effective cancer screening .\
METHODS	We conducted a cluster-randomized trial involving 18 primary care practice sites and 169 PCPs from June 15 , 2011 , to June 14 , 2012 .\
METHODS	Participants included adults eligible for breast , cervical , and/or colorectal cancer screening .\
METHODS	In practices randomized to the intervention group , PCPs reviewed real-time rosters of their patients overdue for screening and provided individualized contact ( via a letter , practice delegate , or patient navigator ) or deferred screening ( temporarily or permanently ) .\
METHODS	In practices randomized to the comparison group , overdue patients were automatically sent reminder letters and transferred to practice delegate lists for follow-up .\
METHODS	Intervention patients without PCP action within 8 weeks defaulted to the automated control version .\
METHODS	The primary outcome was adjusted average cancer screening completion rates over 1-year follow-up , accounting for clustering by physician or practice .\
RESULTS	Baseline cancer screening rates ( 80.8 % vs 80.3 % ) were similar among patients in the intervention ( n = 51,071 ) and comparison group ( n = 52,799 ) .\
RESULTS	Most intervention providers used the IT application ( 88 of 101 , 87 % ) and users reviewed 7984 patients overdue for at least 1 cancer screening ( 73 % sent reminder letter , 6 % referred directly to a practice delegate or patient navigator , and 21 % deferred screening ) .\
RESULTS	In addition , 6128 letters were automatically sent to patients in the intervention group ( total of 12,002 letters vs 16,378 letters in comparison practices ; P < .001 ) .\
RESULTS	Adjusted average cancer screening rates did not differ among intervention and comparison practices for all cancers combined ( 81.6 % vs 81.4 % ; P = .84 ) nor breast ( 82.7 % vs 82.7 % ; P = .96 ) , cervical ( 84.1 % vs 84.7 % ; P = .60 ) , or colorectal cancer ( 77.8 % vs 76.2 % ; P = .33 ) .\
CONCLUSIONS	Involving PCPs in a visit-independent population management IT application resulted in similar cancer screening rates compared with an automated reminder system , but fewer patients were sent reminder letters .\
CONCLUSIONS	This suggests that PCPs were able to identify and exclude from contact patients who would have received automated reminder letters but not undergone screening .\
\
###8968239\
OBJECTIVE	To estimate and compare the costs of surgical and medical treatment of miscarriage to the National Health Service .\
METHODS	A patient-centred , partially randomised trial .\
METHODS	A teaching hospital in Scotland .\
METHODS	Four hundred and thirty-seven women with a proven first trimester miscarriage .\
METHODS	The cost per patient of surgical and medical management of miscarriage plus the extra cost per patient of introducing medical management of miscarriage under three different scenarios are calculated .\
RESULTS	The average cost of surgical treatment was Pounds 397 compared with Pounds 347 for medical treatment .\
RESULTS	Sensitivity analysis showed that the extra cost of introducing the medical management of miscarriage ranged from a cost saving of Pounds 71 per patient to an additional cost of Pounds 47 per patient .\
CONCLUSIONS	Our analysis showed that it may be possible to generate cost savings by introducing medical methods in the management of early miscarriage .\
CONCLUSIONS	However , the savings assume that costs associated with theatre use can be fully realised .\
\
###15077929\
BACKGROUND	Bronchoalveolar lavage ( BAL ) is a fundamental technique in the diagnosis of different respiratory diseases including lung cancer .\
BACKGROUND	Tumor marker values can be determined in the BAL fluid , but controversy still exists about how to express the results .\
OBJECTIVE	The aim of this study was to determine the best method of expressing tumor markers in BAL , either referring to total proteins or volume of fluid recovered .\
METHODS	A prospective , randomized , non-blind study was carried out .\
METHODS	Seventy-six patients ( 72 men and 4 women ) diagnosed with lung cancer and 17 subjects without respiratory disease were included .\
METHODS	BAL was performed in all patients and the fluid retrieved was divided into two fractions : a bronchiolar fraction ( F0 ) and an alveolar fraction ( F1 ) .\
METHODS	Five tumor markers : cytokeratin fragment 19 ( CYFRA 21-1 ) , squamous cell carcinoma antigen ( SCC ) , tissue polypeptide antigen ( TPA ) , tissue polypeptide-specific antigen ( TPS ) and neuron-specific enolase ( NSE ) as well as total protein were measured in both fractions .\
METHODS	The concentrations were expressed in relation to the volume of BAL fluid recovered ( ng or mU/mL ) and in milligrams of total protein of lavage fluid ( ng or mU/mg TP ) .\
METHODS	The SPSS 11.01 software was used for statistical analysis .\
METHODS	Mann-Whitney U test and ROC curves were developed when significant differences were found .\
RESULTS	We found significant differences in the CYFRA 21-1 values in the two BAL fractions and in both ways of expressing its concentration ; in SCC in F1 expressed in ng/mg TP ; in TPA in F0 expressed in mU/mg TP ; in TPS in both fractions expressed in mU/mg TP , and in NSE in both fractions in ng/mg TP .\
RESULTS	The markers that best differentiated tumors from controls ( ROC curves ) were CYFRA 21-1 in F0 and NSE in both fractions in ng/mg TP .\
CONCLUSIONS	Our study demonstrates that the concentrations of tumor markers in BAL expressed in relation to total protein were more effective than if expressed in mL of BAL fluid collected .\
\
###12899797\
OBJECTIVE	A number of studies had evaluated the benefit of neoadjuvant chemotherapy combined surgery on stage IIIa-IIIb NSCLC , survival benefit was found in several papers .\
OBJECTIVE	We attempt to evaluate the survival and prognosis of cisplatinum-based schedule as peri-operative CT for resectable stage I-IIIa NSCLC .\
METHODS	A prospective , randomized , multicenter study was conducted by Shanghai Lung Cancer Team ( supported by Shanghai Branch of Discipline Foundation ) since 1995-1997 for 211 cases of stage I-IIIa NSCLC with curative resection ( 99 stage I , 47 stage II , 65 stage III ) , age of < or = 75 , KPS > or = 80 , staged by 1997 AJC TNM Criteria .\
METHODS	They were randomized to be 103 cases with 1 - 2 cycles of pre-operative CT and 108 cases with no pre-operative CT , 2 - 4 cycles of post-operative CT were used for stage II and stage IIIa NSCLC , it was totally 4 cycles of MVP or MOP CT schedule each case .\
METHODS	Follow-up team had been trained , the follow-up rate should be > or = 95 % , last follow-up date was March of 2002 .\
METHODS	Lobectomy was performed for most patients .\
METHODS	Accumulated survival , log rank , MST , Cox uni-variance and multi-variance analyses were used as statistics for evaluation .\
RESULTS	The two arms were well balanced for baseline demographic and clinical characteristics ( P > 0.05 for all ) .\
RESULTS	Stage I NSCLC had the best year-survival in whole patients .\
RESULTS	No statistical survival difference was found between the group with pre-op CT and with no pre-op CT , P = 0.074 , 0.087 and 0.097 , respectively , 5-year survival rates were of 31.98 % :36.68 % .\
RESULTS	In various stage , a statistical survival difference was only shown in stage IINSCLC , P = 0.042 , 5-year survival rates and MST were worse in the group with pre-operation CT , 20 % :65.2 % and 24 months :48 months , respectively , but no difference was seen in stage I and stage IIIa NSCLC .\
RESULTS	Stage and post-operation CT were the only two meaningful parameters with statistical survival difference calculated by multi-variance analyses , P = 0.000 all , but no difference was found in others 4 parameters ( age , sex , type and pre-operation CT ) .\
RESULTS	The response rate of pre-operation CT was of 50 % .\
RESULTS	Though there was no statistical difference , the responders were with slightly better year-survival rates than MR + NR patients , 38.9 % and 33.3 % , respectively .\
RESULTS	In the cases with pathological `` T '' down stage and `` T '' unchanged after pre-operation CT had a better yr-survival rates than `` T '' up-stage , P = 0.03 , 5-year survival rates were of 41.67 % , 40.51 % and 11.76 % , respectively , thus , effective chemotherapy might be beneficial to survival .\
RESULTS	Besides , in the cases with > or = 3 cycles of post-operation CT have better survival rates than less cycles .\
CONCLUSIONS	A prospective , randomized , multicenter peri-operation CT study for stage I-IIIa NSCLC conducted in Shanghai , China. , it showed there had no benefit in survival between with pre-operation CT arm and with no pre-operation CT arm .\
CONCLUSIONS	In stage II NSCLC , pre-operation CT cases had a worse year-survival than with no pre-operation CT , P = 0.042 , but no difference was seen in stage I and stage IIIa NSCLC .\
CONCLUSIONS	The responder of CT and `` T '' down stage , `` T '' unchanged had better survival rates than those of not response and `` T '' up-stage .\
CONCLUSIONS	From multivariate analyses , stage and post-operation CT were the two meaningful parameters to year-survival , > or = 3 - 4 cycles of post-operation CT had a better statistical higher year-survival than less cycles .\
CONCLUSIONS	Nutrition , supportive treatment , immunity status and prevention of toxicity might be the next study worthy to conduct , for CT combined with OP .\
\
###24297654\
OBJECTIVE	Circumferential excisional hemorrhoidectomy ( CEH ) enables the surgeon to remove the encircling hemorrhoids completely .\
OBJECTIVE	The purpose of this study is to compare the efficacy of CEH with that of Ferguson hemorrhoidectomy ( FH ) for end-stage hemorrhoids .\
METHODS	Between February 1998 and December 2011 , a prospective randomized trial was conducted with 688 patients who presented with end-stage hemorrhoids and underwent FH or CEH at our center .\
RESULTS	The patient demographics , mean operative times , lengths of hospital stay , and cumulative rates of postoperative complications were similar in the study groups .\
RESULTS	Significant differences were revealed in the incidence of postoperative hemorrhage ( 9 vs. 0 patients in the FH and CEH groups , respectively ; p = 0.002 ) and in the tendency to form anal stricture ( 15 vs. 32 patients in the FH and CEH groups , respectively ; p = 0.02 ) .\
RESULTS	However , all cases of anal strictures were easily managed by digital dilatations .\
RESULTS	At a mean follow-up of 7.4 ( range , 1-14 ) years , accessible patients from the CEH group remained symptom free , whereas 126 of 308 patients in the FH group indicated that they had recurrent hemorrhoidal symptoms .\
CONCLUSIONS	Without increasing postoperative complications , CEH demonstrates an advantage compared with FH , with regard to reducing the rate of recurrence to 0 through complete hemorrhoid removal .\
\
###21746696\
BACKGROUND	Patients look to their family physicians ( FPs ) for credible information and guidance in making informed choices about genetic testing .\
BACKGROUND	FPs are challenged by lack of knowledge and the rapid pace of genetic discovery .\
BACKGROUND	There is an urgent need for effective interventions to facilitate integration of genetics into family medicine .\
OBJECTIVE	To determine if a multi-faceted knowledge translation intervention would improve skills , including referral decisions , confidence in core genetics competencies and knowledge .\
METHODS	Randomized controlled trial involving FPs in four communities in Ontario , Canada ( two urban and two rural ) .\
METHODS	The intervention consisted of an interactive educational workshop , portfolio of practical clinical genetics tools and knowledge service called Gene Messenger .\
METHODS	Outcome measures included appropriate genetics referral decisions in response to 10 breast cancer scenarios , decisional difficulty , self-reported confidence in 11 genetics core competencies , 3 knowledge questions and evaluation of intervention components 6 months afterwards .\
RESULTS	Among the one hundred and twenty-five FPs randomized , 80 ( 64 % ) completed the study ( 33 control , 47 intervention ) .\
RESULTS	Intervention FPs had significantly higher appropriate referral decision scores [ 6.4 / 10 [ 95 % confidence interval ( CI ) 5.8-6 .9 ] control , 7.8 / 10 ( 95 % CI 7.4-8 .2 ) intervention ] and overall self-reported confidence on core genetics competencies [ 37.9 / 55 ( 95 % CI 35.1-40 .7 ) control , 47.0 / 55 ( 95 % CI 44.9-49 .2 ) intervention ] .\
RESULTS	Over 90 % of FPs wanted to continue receiving Gene Messengers and would recommend them to colleagues .\
RESULTS	No significant differences were found in decisional difficulty or knowledge .\
CONCLUSIONS	This study demonstrated that a complex educational intervention was able to significantly improve practice intent for clinical genetics scenarios found in primary care , as well as confidence in genetics skills .\
\
###16236892\
BACKGROUND	Cystic fibrosis ( CF ) is characterized by chronic pulmonary infection with acute pulmonary exacerbations ( APEs ) requiring IV antibiotic treatment .\
BACKGROUND	We report on a blinded comparative trial of IV meropenem ( 40 mg/kg to 2 g q8h ) or ceftazidime ( 5 mg/kg to 2 g q8h ) , each of which was administered with IV tobramycin ( at a serum peak of > or = 8 microg/mL and a trough of < 2 microg/mL ) , as treatment for CF patients with APEs .\
METHODS	Patients who were > or = 5 years of age who were infected with ceftazidime-susceptible Pseudomonas aeruginosa were stratified by lung function and randomized to treatment with meropenem/tobramycin or ceftazidime/tobramycin .\
METHODS	Patients infected with Burkholderia cepacia complex or ceftazidime-resistant P aeruginosa were assigned to receive open-label meropenem/tobramycin .\
METHODS	Clinical response was assessed by spirometry to determine the change in percent predicted FEV1 and by a clinical acute change score ( ACS ) .\
RESULTS	One hundred two patients were randomized to meropenem/tobramycin ( n = 50 ) or ceftazidime/tobramycin ( n = 52 ) .\
RESULTS	Nineteen patients received open-label meropenem/tobramycin .\
RESULTS	FEV1 was improved at the end of treatment ( EOT ) with meropenem/tobramycin ( mean [ + / - SD ] increase , 38.8 + / - 52.3 % ) and with ceftazidime/tobramycin ( mean increase , 29.4 + / - 35.1 % ; p < 0.0001 vs baseline values ) .\
RESULTS	The proportion of patients with > or = 15 % relative increase from baseline FEV1 ( satisfactory response ) at day 7 was 62 % for the meropenem/tobramycin group and 44 % for the ceftazidime/tobramycin group ( p = 0.04 ) .\
RESULTS	The median time to FEV1 response was 4 days for meropenem/tobramycin therapy vs 6 days for ceftazidime/tobramycin therapy .\
RESULTS	Similarly , FEV1 improved in the open-label group ( mean increase , 12.5 + / - 25.7 % ; p = 0.05 ) .\
RESULTS	ACS improved in all three groups at EOT ( p < 0.0001 vs baseline values ) .\
CONCLUSIONS	Therapy with both meropenem/tobramycin and ceftazidime/tobramycin improved pulmonary and clinical status and reduced sputum bacterial burden in CF patients with APEs .\
CONCLUSIONS	A larger proportion of patients receiving meropenem/tobramycin therapy demonstrated a satisfactory FEV1 response at day 7 .\
CONCLUSIONS	Resistant P aeruginosa emerged infrequently during treatment with both regimens .\
\
###19726374\
OBJECTIVE	To evaluate the effect of Helicobacter pylor ( Hp ) eradication in children with acute idiopathic thrombocytopenic purpura ( ITP ) .\
METHODS	Ninety-three children with acute ITP and Hp infection were divided into two groups and treated with prednisone and Hp eradication ( group A , 51 cases ) or with prednisone without Hp eradication ( group B , 42 cases ) .\
RESULTS	The Hp eradication rate was 94.1 % in group A. No difference was found in the therapeutic effects on IPT between the two groups , but the recurrence rate in one year in group A was significantly lower than that in group B.\
CONCLUSIONS	NHp eradication does not obviously enhance the therapeutic effect on childhood acute ITP , but can decrease the relapse rate in one year .\
CONCLUSIONS	HP eradication therapy is recommended in children with acute ITP and Hp infection .\
\
###1610573\
OBJECTIVE	To compare the effectiveness of three commonly used intraoperative warming devices .\
METHODS	A randomized , prospective clinical trial .\
METHODS	The surgical suite of a university medical center .\
METHODS	Twenty adult patients undergoing kidney transplantation for end-stage renal disease .\
METHODS	Patients were assigned to one of four warming therapy groups : circulating-water blanket ( 40 degrees C ) , heated humidifier ( 40 degrees C ) , forced-air warmer ( 43 degrees C , blanket covering legs ) , or control ( no extra warming ) .\
METHODS	Intravenous fluids were warmed ( 37 degrees C ) , and fresh gas flow was 5 L/min for all groups .\
METHODS	No passive heat and moisture exchangers were used .\
RESULTS	The central temperature ( tympanic membrane thermocouple ) decreased approximately 1 degree C during the first hour of anesthesia in all groups .\
RESULTS	After three hours of anesthesia , the decrease in the tympanic membrane temperature from baseline ( preinduction ) was least in the forced-air warmer group ( -0.5 degrees C + / - 0.4 degrees C ) , intermediate in the circulating-water blanket group ( -1.2 degrees C + / - 0.4 degrees C ) , and greatest in the heated humidifier and control groups ( -2.0 degrees C + / - 0.5 degrees C and -2.0 degrees C + / - 0.7 degrees C , respectively ) .\
RESULTS	Total cutaneous heat loss measured with distributed thermal flux transducers was approximately 35W ( watts = joules/sec ) less in the forced-air warmer group than in the others .\
RESULTS	Heat gain across the back from the circulating-water blanket was approximately 7W versus a loss of approximately 3W in patients lying on a standard foam mattress .\
CONCLUSIONS	The forced-air warmer applied to only a limited skin surface area transferred more heat and was clinically more effective ( at maintaining central body temperature ) than were the other devices .\
CONCLUSIONS	The characteristic early decrease in central temperature observed in all groups regardless of warming therapy is consistent with the theory of anesthetic-induced heat redistribution within the body .\
\
###23444203\
OBJECTIVE	The aim of this randomized controlled clinical trial was to investigate the antimicrobial efficacy of traditional positive pressure ( PP ) irrigation compared with apical negative pressure ( ANP ) in tapered as well as non-tapered root canal preparation techniques .\
METHODS	Patients referred for treatment of mandibular permanent molars with necrotic pulps and apical periodontitis were considered for this study .\
METHODS	A total of 32 eligible teeth were evaluated based on strict inclusion and exclusion criteria and randomly assigned as follows : Group 1 : LightSpeed LSX 0.02 preparation and A NP irrigation ( n = 8 ) .\
METHODS	Group 2 : LightSpeed LSX 0.02 preparation and PP irrigation ( n = 8 ) .\
METHODS	Group 3 : ProTaper preparation and A NP irrigation ( n = 8 ) .\
METHODS	Group 4 : ProTaper preparation and PP irrigation ( n = 8 ) .\
METHODS	A ll teeth were sampled immediately upon access ( S1 ) , after completion of the chemo - mechanical preparation ( S2 ) , and one week later after intracanal medication ( S3 ) .\
METHODS	All samples were microbiologically processed immediately and plated in duplicates on aerobic plates , anaerobic plates , and chocolate plates and colonies statistically analyzed .\
RESULTS	No statistically significant differences were found between groups at S1 .\
RESULTS	When comparing colony-forming unit ( CFU ) levels at S1 and S2 within groups , the reduction was statistically significant in all groups .\
RESULTS	While no significant difference was found in the proportion of teeth that culture positive at either S2 or S3 by shaping groups , a significant difference was noted when comparing PP irrigation and A NP groups .\
RESULTS	The percentage of samples in the PP irrigation group with a negative culture at both time points was 67 % , compared to 100 % among the A NP group .\
CONCLUSIONS	Within the limitations of the present study , taper and apical size failed to demonstrate a difference in microbiological reduction of cultivable bacteria .\
CONCLUSIONS	On the other hand , A NP revealed a significant difference when compared to PP irrigation .\
\
###23179176\
OBJECTIVE	A Phase I study to assess the single and multipledose pharmacokinetics ( PKs ) and safety and tolerability of oromucosally administered ( 9 ) - tetrahydrocannabinol ( THC ) / cannabidiol ( CBD ) spray , an endocannabinoid system modulator , in healthy male subjects .\
METHODS	Subjects received either single doses of THC/CBD spray as multiple sprays [ 2 ( 5.4 mg THC and 5.0 mg CBD ) , 4 ( 10.8 mg THC and 10.0 mg CBD ) or 8 ( 21.6 mg THC and 20.0 mg CBD ) daily sprays ] or multiple doses of THC/CBD spray ( 2 , 4 or 8 sprays once daily ) for nine consecutive days , following fasting for a minimum of 10 h overnight prior to each dosing .\
METHODS	Plasma samples were analyzed by gas chromatography-mass spectrometry for CBD , THC , and its primary metabolite 11-hydroxy-THC , and various PK parameters were investigated .\
RESULTS	( 9 ) - Tetrahydrocannabinol and CBD were rapidly absorbed following single-dose administration .\
RESULTS	With increasing single and multiple doses of THC/CBD spray , the mean peak plasma concentration ( Cmax ) increased for all analytes .\
RESULTS	There was evidence of dose-proportionality in the single but not the multiple dosing data sets .\
RESULTS	The bioavailability of THC was greater than CBD at single and multiple doses , and there was no evidence of accumulation for any analyte with multiple dosing .\
RESULTS	Inter-subject variability ranged from moderate to high for all PK parameters in this study .\
RESULTS	The time to peak plasma concentration ( Tmax ) was longest for all analytes in the eight spray group , but was similar in the two and four spray groups .\
RESULTS	THC/CBD spray was well-tolerated in this study and no serious adverse events were reported .\
CONCLUSIONS	The mean Cmax values ( < 12 ng/mL ) recorded in this study were well below those reported in patients who smoked/inhaled cannabis , which is reassuring since elevated Cmax values are linked to significant psychoactivity .\
CONCLUSIONS	There was also no evidence of accumulation on repeated dosing .\
\
###23706949\
OBJECTIVE	To report 36-month outcomes of RIDE ( NCT00473382 ) and RISE ( NCT00473330 ) , trials of ranibizumab in diabetic macular edema ( DME ) .\
METHODS	Phase III , randomized , multicenter , double-masked , 3-year trials , sham injection-controlled for 2 years .\
METHODS	Adults with DME ( n = 759 ) , baseline best-corrected visual acuity ( BCVA ) 20/40 to 20/320 Snellen equivalent , and central foveal thickness ( CFT ) 275 m on optical coherence tomography .\
METHODS	Patients were randomized equally ( 1 eye per patient ) to monthly 0.5 mg or 0.3 mg ranibizumab or sham injection .\
METHODS	In the third year , sham patients , while still masked , were eligible to cross over to monthly 0.5 mg ranibizumab .\
METHODS	Macular laser was available to all patients starting at month 3 ; panretinal laser was available as necessary .\
METHODS	The proportion of patients gaining 15 Early Treatment Diabetic Retinopathy Study letters in BCVA from baseline at month 24 .\
RESULTS	Visual acuity ( VA ) outcomes seen at month 24 in ranibizumab groups were consistent through month 36 ; the proportions of patients who gained 15 letters from baseline at month 36 in the sham/0 .5 mg , 0.3 mg , and 0.5 mg ranibizumab groups were 19.2 % , 36.8 % , and 40.2 % , respectively , in RIDE and 22.0 % , 51.2 % , and 41.6 % , respectively , in RISE .\
RESULTS	In the ranibizumab arms , reductions in CFT seen at 24 months were , on average , sustained through month 36 .\
RESULTS	After crossover to 1 year of treatment with ranibizumab , average VA gains in the sham/0 .5 mg group were lower compared with gains seen in the ranibizumab patients after 1 year of treatment ( 2.8 vs. 10.6 and 11.1 letters ) .\
RESULTS	Per-injection rates of endophthalmitis remained low over time ( 0.06 % per injection ) .\
RESULTS	The incidence of serious adverse events potentially related to systemic vascular endothelial growth factor inhibition was 19.7 % in patients who received 0.5 mg ranibizumab compared with 16.8 % in the 0.3 mg group .\
CONCLUSIONS	The strong VA gains and improvement in retinal anatomy achieved with ranibizumab at month 24 were sustained through month 36 .\
CONCLUSIONS	Delayed treatment in patients receiving sham treatment did not seem to result in the same extent of VA improvement observed in patients originally randomized to ranibizumab .\
CONCLUSIONS	Ocular and systemic safety was generally consistent with the results seen at month 24 .\
BACKGROUND	Proprietary or commercial disclosure may be found after the references .\
\
###10984013\
OBJECTIVE	A bioavailability study using three different doses was designed to assess the dose proportionality of a new multiple-unit sustained release formulation of sodium valproate .\
OBJECTIVE	SUBIECTS AND METHODS : The study was performed using an open , three-period , randomized , crossover design .\
OBJECTIVE	Twelve healthy male volunteers received on three occasions single oral doses of either 100 mg , 150 mg and 300 mg of a sustained release sodium valproate formulation .\
OBJECTIVE	A wash-out period of at least 7 days elapsed between the administrations .\
OBJECTIVE	Valproic acid was determined in serum by gas chromatography with flame-ionization detector .\
RESULTS	After administration of single doses of 100 mg , 150 mg and 300 mg sodium valproate the population mean curves reached their maxima of 4.3 microg/ml , 6.8 microg/ml and 12.8 microg/ml at 9 h , 9 h and 10 h , respectively .\
RESULTS	The geometric means of AUC0-tz and AUC0-infinity as well as Cmax related to each other approximately according to the expected ratios of 0.33:0.5:1 .\
RESULTS	Point estimates and 90 % confidence intervals for the ratios of geometric means of dose-normalized parameters ( AUC0-tz , AUC0-infinity , Cmax ) were included by the acceptance range of 80-125 % .\
RESULTS	There were no differences in tmax as shown by the inclusion of zero in the 90 % confidence interval for the median difference in tmax between the doses .\
CONCLUSIONS	Parameters determining the extent and rate of absorption ( AUC and Cmax ) increased proportionally with the dose of the new sustained release sodium valproate formulation .\
CONCLUSIONS	This pharmacokinetic behavior offers easier treatment management as dose adjustment is facilitated .\
\
###21336464\
OBJECTIVE	To investigate ownership and perceived utility of written asthma action plans ( WAAPs ) in general practice .\
METHODS	Questionnaires were completed by 225 adults and 75 children with GP-diagnosed asthma from 31 practices .\
METHODS	Regression models for WAAP ownership allowed for confounders and clustering by practice .\
METHODS	Five audio-recorded focus groups were conducted before questionnaire implementation and , 12 months later , six focus groups and additional in-depth interviews with 29 patients and 16 doctors were conducted .\
METHODS	Transcripts were submitted to content and thematic analyses .\
RESULTS	A total of 37 % of adults and 47 % of children had WAAPs .\
RESULTS	Adults reporting spontaneous shortness of breath , an emergency presentation in the previous 12 months , or frequent GP visits were more likely to have a WAAP .\
RESULTS	Qualitative data indicated that few acknowledged receipt or use of one .\
RESULTS	Those who remembered receiving a WAAP found it useful in asthma management in conjunction with verbal advice given by their GP .\
RESULTS	WAAPs were perceived by some patients as an indicator of doctor competence which , in turn , was viewed as signifying better management of asthma by the patient even if the WAAP was never actually used .\
CONCLUSIONS	Ownership of WAAPs is still low .\
CONCLUSIONS	Additional and more effective strategies are required to improve rates of GP prescription of WAAPs .\
\
###22267420\
OBJECTIVE	We hypothesised that melatonin may represent a safe somniferous drug for cardiac patients , and assessed the effects of administering 5 mg of melatonin daily before bedtime for 30 days in patients with coronary artery disease ( CAD ) regarding changes in the nocturnal breathing pattern .\
METHODS	Sixty patients with CAD ( aged 48-80 years ) were randomised to melatonin/placebo treatment in a 2:1 ratio .\
METHODS	A Holter ECG-based method ( Lifescreen Apnea software ) which has been validated as a screening tool for sleep-disordered breathing was used to estimate the apnoea/hypopnoea index ( AHI ) .\
METHODS	A 24-h Holter ECG was used to detect nocturnal breathing abnormalities at the beginning and at the end of the observation .\
METHODS	The values of estimated AHI ( eAHI ) 15 were classified as optimal ( Opt ) and those 15 - as pathological ( Pat ) .\
METHODS	A change of the breathing pattern was classified on the basis of the transition between the initial and final eAHI status ( OptOpt ; OptPat ; PatPat , PatOpt ) .\
METHODS	The mean initial and final value of eAHI and the percent of Opt and Pat values of eAHI in the initial and final assessment were compared between the melatonin and the placebo groups .\
RESULTS	The breathing pattern was not affected by melatonin - the mean initial value of the eAHI in the melatonin group was 18.2 9.4 , and in the placebo group 19.6 12.3 ( p = 0.64 ) , whereas at the end of the observation in the melatonin group it increased by 1.2 11.3 , and in the placebo group - by 1.0 9.0 ( p = 0.44 ) .\
CONCLUSIONS	Hypnagogic treatment with melatonin did not worsen the eAHI in patients with CAD .\
\
###12450709\
OBJECTIVE	This study attempted to find a method of restoring the tensile bond strength of glass ionomer cement ( GIC ) to saliva contaminated enamel under unrinse condition .\
METHODS	One hundred and thirty human non-carious permanent teeth were divided into two major groups .\
METHODS	Either treatment with air drying , acetone , polyacrylic acid , maleic acid , tartaric acid , Scotchbond primer or no treatment at all was applied to both clean and saliva contaminated enamel surfaces prior to GIC placement .\
METHODS	Samples were debonded in tension after 7 days of storage in water using a universal testing machine .\
METHODS	Statistical analysis was performed using one-way ANOVA , Tukey 's studentized range test and Wilcoxon 's rank sums test to determine the significance of the difference of tensile bond strengths within and between the two major groups .\
RESULTS	Bond strength of GIC to clean enamel was 2.46 + / -0.79 MPa while the bond strength of GIC to wet contaminated enamel was significantly reduced to 1.28 + / -0.32 MPa ( p < 0.01 ) .\
RESULTS	However , the bond strengths were restored when the contaminated enamel surfaces were air-dried ( 2.19 + / -0.38 MPa ) or applied with either maleic acid ( 2.80 + / -0.63 MPa ) or Scotchbond primer ( 2.13 + / -0.65 MPa ) before placing GIC over the enamels .\
CONCLUSIONS	Air drying , or application of maleic acid or Scotchbond primer to the contaminated enamel without rinsing prior to GIC placement can restore the tensile bond strength to a level similar to that of non-contaminated control .\
\
###12526235\
BACKGROUND	Tracheal gas insufflation reduces inspired tidal volume and minute ventilation in spontaneously breathing patients and may facilitate weaning from mechanical ventilation .\
OBJECTIVE	To determine if tracheal gas insufflation can reduce ventilatory demand during weaning trials in patients who require prolonged mechanical ventilation .\
METHODS	A reduction in ventilatory demand was defined as a relative decrease in tidal volume , minute ventilation , and mean inspiratory flow during trials with tracheal gas insufflation compared with the values during trials without this therapy .\
METHODS	A total of 14 subjects underwent T-piece trials with and without insufflation ( flow rate 6 L/min ) on 2 consecutive days ; the order of insufflation was randomized .\
METHODS	Tidal volume , minute ventilation , and mean inspiratory flow were measured at baseline ( without insufflation ) and 2 hours later .\
RESULTS	Differences in ventilatory demand were not significant when comparisons were made for condition ( tracheal gas insufflation vs no flow ) or time ( baseline vs 2 hours ) for the total group ( P = .48 ) .\
RESULTS	Subjects were classified post hoc as responders ( n = 9 ) or nonresponders ( n = 5 ) .\
RESULTS	Comparisons between responders and nonresponders indicated a significant ( P = .02 ) 3-way multivariate interaction for group ( responder vs nonresponder ) , condition ( tracheal gas insufflation vs no flow ) , and time ( baseline vs 2 hours ) for ventilatory demand variables .\
CONCLUSIONS	Tracheal gas insufflation can reduce ventilatory demand during weaning trials in some patients who require mechanical ventilation .\
\
###14714357\
OBJECTIVE	To explore the protective effect and the mechanism of Puerarin Injection ( PI ) on myocardial ischemia reperfusion in patients with coronary heart disease ( CHD ) and angina pectoris ( AP ) .\
METHODS	Seventy-eight patients with AP planned to receive the PTCA and stenting treatment were randomly divided and single-blindedly into the conventional group and the PI group .\
METHODS	Based on the conventional treatment and pre-operational preparation , the PI group was given 200 ml of PI by intravenous dripping once a day , beginning from one week before operation , but to the conventional group , normal saline was given for instead .\
METHODS	The condition of AP attack in balloon dilatatory stage of PTCA was observed and change of ST segment of ECG detected by a 12-lead ECG monitor .\
METHODS	The blood levels of von Willebrand factor ( vWF : Ag ) , nitric oxide ( NO ) and endothelin-1 ( ET-1 ) were also observed before and after treatment .\
RESULTS	As compared with those in the conventional group , number of patients having AP attack and ST segment change in PTCA process was lessened in the PI group , with blood levels of vWF : Ag and ET-1 obviously lower , and NO content obviously higher than those in the conventional group ,\
CONCLUSIONS	PI could protect the myocardium in 2-3 days after ischemia reperfusion , one of the possible reasons is that PI can simulate the late phase of ischemic preconditioning , which may be related to its effect in lowering plasma vWF : Ag and ET-1 , and increasing the serum NO content .\
\
###22924756\
OBJECTIVE	This study compared the antimicrobial effects of three commercial dentifrice formulations : sodium fluoride/triclosan/copolymer ( TCN/C ) , stannous fluoride/sodium hexametaphosphate/zinc lactate ( SnF ( 2 ) / SHMP ) and sodium fluoride ( NaF ) .\
METHODS	Thirty-five adults ( 15 men and 20 women ; average age 33 years and pockets < 5 mm ) completed this double-blind , triple-crossover study .\
METHODS	After washout , baseline samples from four sites , plaque , saliva , tongue and buccal mucosa , were collected and evaluated for six microbial types , anaerobes , Streptococci , Actinomyces , hydrogen-sulphide ( H ( 2 ) S ) - producing bacteria , Fusobacteria and Veillonella .\
METHODS	A specific dentifrice was randomly assigned for twice-daily use for 13 days .\
METHODS	On day 14 , 12 h after brushing , samples were collected for microbiological evaluations .\
METHODS	Alternate dentifrices followed this identical protocol .\
RESULTS	For all four oral sites and six organisms evaluated in each site , the TCN/C demonstrated significant reductions ( 49-83 % ) as compared with the other treatments ( p < 0.01 ) .\
RESULTS	The SnF ( 2 ) / SHMP group showed significant reductions of 14-43 % for 14 of 24 outcomes as compared with the NaF group ( p < 0.01 ) , with no differences in 10 outcomes .\
CONCLUSIONS	The TCN/C dentifrice formulation consistently demonstrated significant reductions for a range of microorganisms in diverse oral sites in comparison with the NaF , or the SnF ( 2 ) / SHMP dentifrice formulations as seen 12 h after brushing .\
\
###21317794\
OBJECTIVE	To determine the antiviral activity , pharmacokinetics , pharmacodynamics , safety , and tolerability of several dose levels of oral TBR-652 monotherapy in HIV-1-infected , antiretroviral experienced , CCR5 antagonist-naive subjects .\
METHODS	Double-blind placebo-controlled study in the United States and Argentina .\
METHODS	Subjects were randomized in a ratio of 4:1 per dose level to TBR-652 ( 25 , 50 , 75 , 100 , or 150 mg ) or placebo , taken once daily for 10 days .\
METHODS	Changes from baseline in HIV-1 RNA and CD4 cell counts were measured through day 40 and for monocyte chemotactic protein-1 ( MCP-1 ) , high-sensitivity C-reactive protein ( hs-CRP ) , and IL-6 at day 10 .\
METHODS	Pharmacokinetic data were analyzed using noncompartmental statistics .\
METHODS	Laboratory and clinical adverse events ( AEs ) and electrocardiogram changes were recorded .\
RESULTS	Maximum median reductions in HIV-1 RNA values for the 25 , 50 , 75 , and 150 mg doses were -0.7 , -1.6 , -1.8 , and -1.7 log10 copies per milliliter , respectively .\
RESULTS	All changes were significant .\
RESULTS	Median time to nadir was 10-11 days .\
RESULTS	Suppression persisted well into the posttreatment period .\
RESULTS	Mean MCP-1 increased significantly by day 10 in the 50-mg and 150-mg dose groups .\
RESULTS	Effects on CD4 cell counts , hs-CRP , and IL-6 levels were negligible .\
RESULTS	TBR-652 was generally safe and well tolerated , with no withdrawals due to AEs .\
CONCLUSIONS	TBR-652 caused significant reductions in HIV-1 RNA at all doses .\
CONCLUSIONS	Significant increases in MCP-1 levels suggested a strong CCR2 blockade .\
CONCLUSIONS	TBR-652 was generally well tolerated with no dose-limiting AEs .\
CONCLUSIONS	Pharmacodynamics indicate that TBR-652 warrants further investigation as an unboosted once-daily oral CCR5 antagonist with potentially important CCR2-mediated anti-inflammatory effects .\
\
###17826428\
OBJECTIVE	The purpose of this study was to assess whether knowledge of ST-segment analysis was associated with a reduction in operative deliveries for nonreassuring fetal status ( NRFS ) or with a need for at least 1 scalp pH during labor .\
METHODS	Seven hundred ninety-nine women at term with abnormal cardiotocography or meconium-stained amniotic fluid ( 7 % ) were assigned randomly to the intervention group ( cardiotocography + STAN ) or the control group ( cardiotocography ) in 2 university hospitals in Strasbourg , France .\
METHODS	Scalp pH testing was optional in both groups .\
METHODS	Abnormal neonatal outcome was pH < 7.05 or umbilical cord blood artery base deficit of > 12 or a 5-min Apgar score of < 7 or neonatal intensive care unit admission or convulsions or neonatal death .\
METHODS	Study power was 80 % for the detection of a prespecified reduction from 50 % -40 % in operative delivery for NRFS .\
RESULTS	The operative delivery ( cesarean or instrumental ) rate for NRFS did not differ between the 2 groups : 33.6 % ( 134/399 ) in the cardiotocography + STAN analysis group vs 37 % ( 148/400 ) in the cardiotocography group ( relative risk , 0.91 ; 95 % CI , 0.75-1 .10 ) .\
RESULTS	The rate of operative delivery for dystocia was also similar in both groups .\
RESULTS	The percentage of women whose fetus had at least 1 scalp pH measurement during labor was substantially lower in the group with ST-segment analysis : 27 % compared with 62 % ( relative risk , 0.44 ; 95 % CI , 0.36-0 .52 ) .\
RESULTS	Neonatal outcomes did not differ significantly between groups .\
CONCLUSIONS	In a population with abnormal cardiotocography in labor , cardiotocography combined with ST-segment analysis was not associated with a reduction in operative deliveries for NRFS .\
CONCLUSIONS	The proportion of infants without scalp pH sampling during labor increased substantially , however .\
\
###20329605\
OBJECTIVE	To investigate the clinical efficacy of modified Sanmiao Powder ( SMP ) in treating chronic uric acid nephropathy ( CUAN ) .\
METHODS	Ninety-four patients with CUAN were equally randomized to the treated group and the control group .\
METHODS	Conventional treatment was given to all patients and the treated group was administered with SMP additionally for 12 weeks .\
METHODS	Changes of symptoms were observed , and laboratory indexes , as urinary protein quantity ( UPro ) , urinary RBC count ( URBC ) , urinary beta2 microglobulin ( beta2-M ) , urinary beta-N-acetylglucosaminidase ( NAG ) , blood urea nitrogen ( BUN ) , serum creatine ( SCr ) and serum uric acid ( SUA ) , were detected before and after treatment .\
RESULTS	The total effective rate in the treated group was 87.2 % ( 41/47 ) , and in the control group was 61.7 % ( 21/47 ) , showing significant difference between groups ( P < 0.01 ) ; significant improvement of UPro , URBC , beta2-M , NAG , BUN , SCr and SUA were shown in the treated group ( P < 0.05 , P < 0.01 ) ; but in the control group , only URBC count was significantly decreased ( P < 0.05 ) , no statistically significant change of other indexes was found ( P > 0.05 ) .\
RESULTS	SUA decreased in both groups ( P < 0.01 ) , which was markedly lower in the treated group than in the control group ( P < 0.05 ) ; SCr and BUN were also decreased in the treated group ( P < 0.01 ) .\
CONCLUSIONS	Combined therapy of SMP and conventional Western medicine shows a favorable effect in treating CUAN .\
CONCLUSIONS	It could not only reduce SUA , but also alleviate the albuminuria and hematuria , lower the urinary levels of beta2-M and NAG to improve renal function .\
\
###26255508\
OBJECTIVE	To compare the differences in the clinical efficacy on post-stroke upper limb spasmodio hemiplegia among the combined therapy of relaxing needling ( Huici ) technique combined with wheat-grain moxibustion , simple relaxing needling and conventional acupuncture .\
METHODS	Ninety patients were-randomized into a group with the combined therapy of relaxing needling technique combined with wheat-grain moxibustion ( a combined therapy group ) , a simple relaxing needling group and a conventional acupuncture group , 30 cases in each group .\
METHODS	In the combined therapy group , the relaxing needling technique was used in combination with wheat-grain moxibustion .\
METHODS	The relaxing needling technique was applied to Jianyu ( LI 15 ) , Quchi ( LI 11 ) , Shousanli ( LI 10 ) , etc. .\
METHODS	The wheat-grain moxibustion was applied to Qihai ( CV 6 ) , Guanyuan ( CV 4 ) , Mingmen ( GV 4 ) , etc. .\
METHODS	In thel simple relaxing needling group , the relaxing needling technique was used simply .\
METHODS	In the conventional acupuncture group , the conventional lifting , thrusting and rotating technique with filiform needle was adopted at the same acupoints as the simple relaxing needling group .\
METHODS	The treatment was given once every day ; 6 treatments made one session .\
METHODS	Totally 4 sessions were required , with 1 day at intervals .\
METHODS	The modified Ashworth scale ( MAS ) , Fugl-Meyer assessment ( FMA ) and Barthel index ( BD were adopted to assess the upper limb muscle tension , motor functioni and daily life activity .\
RESULTS	After treatment , MAS score was all reduced as compared with that before treatment in each group , and FMA score and BI score were increased as compared with those before treatment ( all P < 0.01 ) .\
RESULTS	MAS score in the combined therapy group was lower than that in either the simple relaxing needling group or the conventional acupuncture group ( both P < 0.01 ) , and the score in the simple relaxing needling group was lower than that in the conventional acupuncture group ( P < 0.05 ) .\
RESULTS	FMA score and BI score in the combined therapy group were higher than those in the simple relaxing needling group and the conventional acupuncture group ( both P < 0.01 ) .\
RESULTS	FMA score in the simple relaxing needleing group was higher than that the Enventional acupuncture group ( P < 0.05 ) .\
RESULTS	The total effective rate in the combined therapy group was 93.3 % ( 28/30 ) , higher ; than 86.7 % ( 26/30 ) in the simple relaxing needling group ( P < 0.01 ) , and 83.8 % ( 25/30 ) in the conventionaP acupuncture group ( P < 0.01 ) .\
CONCLUSIONS	The combined therapy of relaxing needling technique and wheat-grain moxibustion achieves more satisfactory efficacy on post-stroke upper limb spasmodic hemiplegia compared with the simple relaxing needling and conventional acupuncture .\
\
###16359206\
OBJECTIVE	Factors that adversely affect early recovery after major laparoscopic procedures include ileus , pain , nausea , emesis , and fatigue .\
OBJECTIVE	The objective of this randomized controlled study was to evaluate the impact of a multimodal fast-track ( FT ) rehabilitation program on recovery and length of hospital stay after laparoscopic nephrectomy .\
METHODS	Thirty patients undergoing laparoscopic nephrectomy received either conventional care ( control ) or an FT recovery program .\
METHODS	All patients received a standardized anesthetic technique and patient - controlled analgesia ( morphine ) for postoperative pain control .\
METHODS	In the FT group , patients received premedication with rofecoxib and ranitidine , local anesthesia was administered at the ports and renal fosa during surgery , and postoperative non-opioid analgesic and gastrokinetic drugs were administered as part of an early enteral nutrition and mobilization program .\
METHODS	During the postoperative period , pain and nausea were assessed at specific time intervals .\
METHODS	In addition , recovery room and hospital discharge times , the need for rescue analgesics and antiemetics , patient satisfaction with pain management and quality of recovery , and side effects were recorded daily for 3 days after surgery .\
METHODS	Patients were discharged home when they met previously defined discharge criteria .\
RESULTS	The FT group was discharged earlier from the recovery room ( 74 + / -23 v 103 + / -47 minutes ) and the hospital ( 41 + / -11 v 59 + / -11 hours ) .\
RESULTS	Pain and nausea scores were consistently lower in the FT group during the first 48 hours after surgery .\
RESULTS	In addition , the requirement for antiemetic rescue therapy during the first 24 hours was reduced in the FT group ( 15 % v 58 % ) .\
RESULTS	The FT group also received less morphine during the first 2 postoperative days ( 14 + / -16 v 40 + / -24 mg ) .\
RESULTS	Finally , patient satisfaction with postoperative pain control was significantly higher in the FT group .\
CONCLUSIONS	A multimodal approach to minimizing postoperative side effects led to a reduced recovery room and hospital stay , as well as better pain control and patient satisfaction after laparoscopic nephrectomy .\
\
###11203962\
OBJECTIVE	The purpose of this investigation was to evaluate microleakage in Class II cavities restored with the condensable resin composite SureFil , placed with or without a liner and 1 of 2 different dentin bonding agents .\
METHODS	Extracted noncarious human teeth were randomly divided into 4 groups of 15 each and restored according to manufacturer 's instructions : group 1 , SureFil and Prime & Bond NT ; group 2 , SureFil and PQ1 ; group 3 , SureFil , PermaFlow , and PQ1 ; group 4 , Heliomolar and Syntac Single-Component ( control ) .\
METHODS	Specimens were stored in 37 degrees C water for 24 hours .\
METHODS	All specimens were thermocycled between 5 degrees C and 55 degrees C for 500 cycles .\
METHODS	Each specimen was immersed in 0.2 % basic fuchsin dye for 24 hours and then sectioned longitudinally and horizontally .\
METHODS	Dye penetration at enamel and cementum margins were viewed at x30 magnification by 2 independent , calibrated evaluators .\
METHODS	Specimens exhibiting dye penetration > or = 0.1 mm beyond the cavosurface margin were considered to have leakage .\
RESULTS	Chi-square tests revealed no statistically significant differences in the presence of microleakage when all groups were analyzed together .\
RESULTS	However , 2 by 2 comparisons revealed that group 3 had significantly fewer specimens with microleakage than did group 1 , 2 , or 4 .\
CONCLUSIONS	To limit microleakage , a flowable composite should be used as a liner when a condensable composite material is used .\
\
###25220898\
BACKGROUND	Pain is highly prevalent among persons with HIV .\
BACKGROUND	Alcohol may be used to `` self-medicate '' pain .\
BACKGROUND	This study examined the association between pain and risky alcohol use over time in a cohort of HIV-infected Russian drinkers .\
METHODS	This secondary analysis utilized longitudinal data from a randomized trial of a behavioral intervention .\
METHODS	Subjects included HIV-infected adults who reported past 6-month risky drinking and unprotected sex and were recruited from HIV and addiction treatment sites in St. Petersburg , Russia .\
METHODS	The main independent variable was pain that at least moderately interfered with daily living .\
METHODS	The primary outcome was past month risky drinking amounts based on NIAAA guidelines .\
METHODS	General estimating equations ( GEE ) logistic regression models were used to calculate odds ratios and 95 % confidence intervals for the association between pain and risky drinking over time ( i.e. , baseline , 6 and 12 months ) , adjusting for potential confounders .\
RESULTS	Baseline characteristics of participants ( n = 699 ) were mean age of 30 ( SD 5 ) years , 41 % female , and 22 % < 9th grade education .\
RESULTS	Nearly one quarter ( 24 % ) had a CD4 cell count < 200 cells/l , and only 17 % were on antiretroviral therapy .\
RESULTS	Nearly half ( 46 % ) reported at least moderate pain interference in the past month and 81 % were drinking risky amounts .\
RESULTS	In adjusted longitudinal GEE models , pain was significantly associated with greater odds of reporting past month risky drinking ( AOR = 1.34 , 95 % CI : 1.05-1 .71 , p value = 0.02 ) .\
CONCLUSIONS	Among a cohort of HIV-infected Russian drinkers , pain that at least moderately interfered with daily living was associated with higher odds of reporting risky drinking amounts over time .\
\
###1336526\
OBJECTIVE	To determine the effects of potassium chloride 60 mmol/day supplementation on clinic and 24-h ambulatory blood pressure values in elderly untreated hypertensive patients .\
METHODS	A double-blind randomized placebo-controlled crossover study lasting 8 weeks , following a 4-week run-in period .\
METHODS	Outpatient clinic in a district general hospital .\
METHODS	Eighteen untreated elderly hypertensive patients ( mean age 75 years , range 66-79 ) with a systolic blood pressure of > or = 160 mmHg and/or a diastolic blood pressure of > or = 95 mmHg were recruited from the clinics of local general practitioners and from the current hospital outpatient department .\
METHODS	Patients had not received any antihypertensive medication for at least 4 weeks before entry into the study .\
METHODS	Before entry into the study , the daily dietary electrolyte intake of each individual was established and this was maintained during the run-in and intervention periods .\
METHODS	Following a 4-week run-in period patients received potassium supplements or matching placebo , each for 4 weeks .\
METHODS	The within-patient changes in clinic and 24-h ambulatory blood pressures at the end of each intervention period .\
RESULTS	After 4 weeks potassium supplementation compared with placebo there was a significant fall in supine clinic blood pressure , standing and 24-h ambulatory systolic blood pressure .\
RESULTS	There was no significant change in clinic standing diastolic blood pressure , 24-h ambulatory diastolic blood pressure or pulse rate .\
RESULTS	Plasma renin activity increased and body weight fell after potassium supplementation .\
RESULTS	Twenty-four-hour urinary potassium rose significantly , whereas urinary sodium excretion was unchanged .\
CONCLUSIONS	A 60-mmol daily supplement of potassium chloride reduces clinic and 24-h ambulatory blood pressure in elderly hypertensive patients .\
\
###18565251\
OBJECTIVE	The goal of this study has been to determine whether hyaluronic acid ( HA ) or exercise therapy can improve functional parameters in patients with osteoarthritis ( OA ) of the ankle .\
METHODS	In a prospective clinical trial , 43 ankles ( 30 patients ) with radiographic Kellgren Lawrence grade III OA were randomized to receive three intra-articular HA injections , with one-week interval of or exercise therapy for six weeks .\
METHODS	Patients were evaluated by the American Orthopaedic Foot and Ankle Society ( AOFAS ) Ankle-Hindfoot Scale and followed-up after 12 months .\
RESULTS	Total AOFAS Ankle-Hindfoot score of OA patients has improved in both groups , varying from 61.6 + / -16.8 to 90.1 + / -9.7 with HA treatment and from 72.1 + / -16.6 to 87.5 + / -17.5 using exercise therapy at the end of the trial ( p < 0.01 ) .\
RESULTS	There were no statistically significant differences between the groups .\
CONCLUSIONS	This prospective randomized trial confirmed that , both HA injections and exercise therapy provide functional improvement .\
CONCLUSIONS	However , larger trials with longer follow-up are necessary for more definite conclusions .\
\
###23155122\
BACKGROUND	Accumulating evidence has linked depressive symptoms and sex hormones to risk for relapse ; however , the specific mechanisms involved in these associations remain unknown .\
BACKGROUND	This randomized crossover study assessed physiological response to nicotine by menstrual phase in female smokers with and without depressive symptoms following acute smoking abstinence .\
METHODS	Females , ages 18-40 years with regular menstrual cycles , not on exogenous hormones or psychotropic medications , who reported smoking 5 cigarettes/day were enrolled .\
METHODS	Participants were stratified into 2 groups : no depressive symptoms ( NDS ; n = 23 ) and depressive symptoms ( DS ; n = 24 ) .\
METHODS	After 4 days of biochemically verified smoking abstinence , participants completed 2 laboratory sessions in the follicular ( F ) and luteal ( L ) phases .\
METHODS	Participants used nicotine nasal spray at Time 0 , and blood pressure , heart rate , and serum nicotine were measured at Time -1 , 5 , 10 , 20 , 30 , 45 , 60 , and 90 min .\
RESULTS	Participants ( n = 47 ) were 29.1 6.8 years old and smoked an average of 12.5 5.1 cigarettes/day .\
RESULTS	The NDS group had more pronounced menstrual phase differences ( F > L ) in diastolic blood pressure , heart rate , and maximum concentrations of nicotine compared with the DS group ( p < .05 ) .\
CONCLUSIONS	This study observed an interaction between sex hormones and depressive symptoms such that those without depressive symptoms had a greater menstrual phase difference in the physiological response to nicotine .\
CONCLUSIONS	These data offer additional support for the role of sex hormones in the physiological response to nicotine , which may play a role in menstrual phase effects on smoking cessation .\
\
###22765882\
BACKGROUND	Low adherence to chronic kidney disease ( CKD ) guidelines may be due to unrecognized CKD and lack of guideline awareness on the part of providers .\
BACKGROUND	The goal of this study was to evaluate the impact of provider education and access to a CKD registry on guideline adherence .\
METHODS	We conducted a cluster randomized controlled trial at the Louis Stokes Cleveland VAMC .\
METHODS	One of two primary care clinics was randomized to intervention .\
METHODS	Providers from both clinics received a lecture on CKD guidelines at study initiation .\
METHODS	Providers in the intervention clinic were given access to and shown how to use a CKD registry , which identifies patients with CKD and is automatically updated daily .\
METHODS	Eligible patients had at least one primary care visit in the last year , had CKD based on eGFR , and had not received renal replacement therapy .\
METHODS	The primary outcome was parathyroid hormone ( PTH ) adherence , defined by at least one PTH measurement during the 12month study .\
METHODS	Secondary outcomes were measurement of phosphorus , hemoglobin , proteinuria , achievement of goal blood pressure , and treatment with a diuretic or renin-angiotensin system blocker .\
RESULTS	There were 418 and 363 eligible patients seen during the study in the control and intervention clinics , respectively .\
RESULTS	Compared to pre-intervention , measurement of PTH increased in both clinics ( control clinic : 16 % to 23 % ; intervention clinic : 13 % to 28 % ) .\
RESULTS	Patients in the intervention clinic were more likely to have a PTH measured during the study ( adjusted odds ratio = 1.53 ; 95 % CI ( 1.01 , 2.30 ) ; P = 0.04 ) .\
RESULTS	However , the intervention was not associated with a consistent improvement in secondary outcomes .\
RESULTS	Only 5 of the 37 providers in the intervention clinic accessed the registry .\
CONCLUSIONS	An intervention that included education on CKD guidelines and access to a CKD patient registry marginally improved guideline adherence over education alone .\
CONCLUSIONS	Adherence to the primary process measure improved in both clinics , but no improvement was seen in intermediate clinical outcomes .\
CONCLUSIONS	Improving the care of patients with CKD will likely require a multifaceted approach including system redesign .\
CONCLUSIONS	CLINICALTRIALS.GOV REGISTRATION NUMBER : NCT00921687 .\
\
###18179495\
OBJECTIVE	To determine whether counseling and support reduce the burden and depressive symptoms of spouse caregivers of patients with Alzheimer 's disease ( AD ) during the transition to institutionalization .\
METHODS	A randomized , controlled trial of an enhanced counseling and support program for spouse caregivers of persons with AD .\
METHODS	Structured interviews were conducted with spouse caregivers at baseline , every 4 months during Year 1 , and every 6 months thereafter for up to 16 years .\
METHODS	Outpatient research clinic in the New York City metropolitan area .\
METHODS	Referred volunteer sample of 406 spouse caregivers of community-dwelling patients with AD enrolled over a 9.5-year period .\
METHODS	Enhanced counseling and support consisting of six sessions of individual and family counseling , support group participation , and continuous availability of ad hoc telephone counseling .\
METHODS	Outcome measures included burden ( modified Zarit Burden Interview ) and depressive symptoms ( Geriatric Depression Scale ) .\
RESULTS	Burden and depressive symptoms were significantly lower for caregivers in the treatment group than for controls receiving usual care at the time of and after institutionalization .\
RESULTS	Nursing home admission itself significantly reduced burden and depressive symptoms in the intervention and control groups .\
CONCLUSIONS	Institutionalization alone can reduce caregiver burden and depressive symptoms , but enhanced counseling provides additional long-term benefits .\
CONCLUSIONS	The results offer some of the first clinical evidence of the benefits of enhanced counseling during the transition to institutionalization for caregivers of people with AD .\
\
###23804517\
OBJECTIVE	Increased delivery of bile acid salts ( BA ) to distal L-cells and altered TGR5 receptor activation may contribute to the early and substantial increases in gut peptide secretion seen after bariatric surgery .\
OBJECTIVE	To further elucidate a potential role of BA in the secretion of GLP-1 and PYY , we analyzed plasma BA concentrations in 14 morbidly obese patients undergoing gastric bypass or sleeve gastrectomy in a prospective , randomized 1-year trial .\
METHODS	Patients received a standard test meal and blood was collected before and after eating , prior to , and 1 week , 3 months , and 12 months after surgery .\
RESULTS	Pre-surgery , basal BA concentrations were significantly lower in bariatric patients than in healthy controls .\
RESULTS	One year post-surgery , bariatric patients expressed variably increased BA concentrations ( gastric bypass patients 2 fold increase , P0 .05 ) .\
RESULTS	However , whereas in both patient groups , marked increases in GLP-1 and PYY and improved glycemic control was seen already 1 week and 3 months post-surgery , changes in plasma BA followed a different pattern : basal and postprandial plasma BA concentrations increased much slower , more progressively with significant increases only 1-year post-surgery .\
CONCLUSIONS	Based on these findings , BA do not appear to be key mediators of the early increase in GLP-1 and PYY response in post-bariatric patients .\
\
###19139666\
METHODS	Retrospective cohort study .\
OBJECTIVE	Perform a multivariate analysis to identify important predictors of poor outcome following anterior cervical discectomy and fusion .\
BACKGROUND	Identifying prognostic factors is important to aid surgical decision-making and counseling of patients .\
BACKGROUND	Recent randomized control trials of disc arthroplasty devices have established a large cohort of patients treated with fusion and 2-year outcomes that allow analysis of prognostic factors .\
METHODS	The patient cohort was the fusion control patients ( n = 488 ) from 2 randomized controlled studies of disc replacements .\
METHODS	Surgical indications were recalcitrant single-level subaxial radiculopathy or myelopathy .\
METHODS	The surgery included anterior discectomy and fusion with allograft and plate .\
METHODS	Patients were assessed by neck and arm pain , neck disability index ( NDI ) , SF-36 , neurologic examination , and return to work .\
METHODS	Overall clinical success was defined based on meeting all 4 of these criteria : > 15-point improvement in NDI ; maintained or improved neurologic examination ; no serious adverse event related to the procedure ; and no revision of the plate or graft .\
METHODS	Patient 's outcomes were recorded , at 3 , 6 , 12 , and 24 months , with 77 % follow-up at 24 months.The outcome variables for this analysis were overall clinical success and > 15-point improvement in NDI .\
METHODS	We studied the relationship between each of the outcome variables and 26 potential important variables including demographics , medical conditions , socioeconomic factors , and disease state .\
METHODS	Two statistical models were used to explore the association between outcome variables and baseline measures : multivariate logistical regression of the full model with every prognostic variable included and the model with the variables selected by the stepwise selection procedure .\
RESULTS	In the full-model logistic analysis for overall success , worker 's compensation and weak narcotic use were negative predictors while higher preoperative NDI score and normal sensory function were positive predictors .\
RESULTS	For NDI success , only the preoperative NDI scores ( higher disability predictive of improvement ) appeared to have strong influence on the outcome.In the stepwise regression model , preoperative normal sensory function was a positive predictor and worker 's compensation a negative predictors of overall clinical success .\
RESULTS	Greater age , higher preoperative NDI score , and gainful employment were positive predictors and spinal litigation was a negative predictor of NDI success .\
CONCLUSIONS	We found that important predictors of outcome were work status , sensory function , involvement in litigation , and higher disability scores .\
\
###23116683\
BACKGROUND	In the CRYSTAL study adding cetuximab to first-line FOLFIRI significantly improved outcome in patients with KRAS wild-type metastatic colorectal cancer .\
BACKGROUND	Quality of life ( QoL ) was assessed , and associations with tumour response and survival were investigated .\
METHODS	The European Organization for Research and Treatment of Cancer QoL questionnaire-core 30 was used , focusing on global health status ( GHS ) / QoL and social functioning scales .\
METHODS	Radiological response was assessed by an independent review committee .\
RESULTS	QoL was evaluable in 627/666 patients ( 94 % ) with KRAS wild-type tumours ; of these 52 % received FOLFIRI , and 48 % FOLFIRI plus cetuximab .\
RESULTS	Pattern mixture analysis revealed no significant differences for GHS/QoL ( P = 0.12 ) and social functioning scores ( P = 0.43 ) between the treatment arms .\
RESULTS	In additional analyses : early skin reactions in patients receiving cetuximab did not significantly affect these QoL scales , and tumour response was more common ( 58 % versus 40 % , P = 0.0002 ) and survival longer ( Hazard ratio 1.68 , P < 0.0001 ) in asymptomatic compared with symptomatic patients at baseline .\
RESULTS	Adding cetuximab to FOLFIRI was associated with significantly higher tumour response irrespective of patient baseline symptomatic status , and enhanced symptom relief from baseline in those whose tumours had responded .\
CONCLUSIONS	Adding cetuximab to FOLFIRI improved response rate and survival without either improving or negatively impacting on GHS/QoL and social functioning .\
\
###9246253\
BACKGROUND	There have been very few controlled studies of antidepressants in dysthymia , particularly in samples diagnosed reliably and with an adequate length of follow-up .\
BACKGROUND	In this investigation , we measured the long-term outcome in a large group of patients meeting DSM-III-R criteria for dysthymia .\
BACKGROUND	This study was designed to investigate whether fluoxetine is effective in the treatment of dysthymia .\
METHODS	This randomised study including 140 patients , compared fluoxetine ( 91 patients ) and placebo ( 49 patients ) on a double-blind basis in two distinct phases : a short-term end-point ( 3 months with 20 mg/day fluoxetine ) and a medium-term end-point ( 6 months ) where the initial responders continued double-blind treatment unchanged and non-responders received an additional treatment of 20 mg/day fluoxetine .\
RESULTS	After three months of treatment , response was seen more frequently in the fluoxetine group ( 42/72 ) than in the placebo group ( 14/39 , P < 0.0001 ) .\
RESULTS	Improved patients at 3 months were still improved at 6 months .\
RESULTS	Furthermore , 50 % of the nonresponders at 3 months improved and rated as responders at 6 months , after fluoxetine was increased to 40 mg daily .\
CONCLUSIONS	This study showed the significant and persistent action of fluoxetine on dysthymia .\
CONCLUSIONS	The finding that 50 % of the non-responders at 3 months were improved at 6 months , after fluoxetine dosage was increased to 40 mg daily , argues in favour of treating dysthymic patients for at least 6 months , and with a higher dosage if the initial doses are ineffective .\
\
###22353644\
OBJECTIVE	To compare vasopressin and adrenaline in the treatment of patients with cardiac arrest presenting to or in the Emergency Department ( ED ) .\
METHODS	A randomised , double-blind , multi-centre , parallel-design clinical trial in four adult hospitals .\
METHODS	Eligible cardiac arrest patients ( confirmed by the absence of pulse , unresponsiveness and apnea ) aged > 16 ( aged > 21 for one hospital ) were randomly assigned to intravenous adrenaline ( 1mg ) or vasopressin ( 40 IU ) at ED .\
METHODS	Patients with traumatic cardiac arrest or contraindication for cardiopulmonary resuscitation ( CPR ) were excluded .\
METHODS	Patients received additional open label doses of adrenaline as per current guidelines .\
METHODS	Primary outcome was survival to hospital discharge ( defined as participant discharged alive or survival to 30 days post-arrest ) .\
RESULTS	The study recruited 727 participants ( adrenaline = 353 ; vasopressin = 374 ) .\
RESULTS	Baseline characteristics of the two groups were comparable .\
RESULTS	Eight participants ( 2.3 % ) from adrenaline and 11 ( 2.9 % ) from vasopressin group survived to hospital discharge with no significant difference between groups ( p = 0.27 , RR = 1.72 , 95 % CI = 0.65-4 .51 ) .\
RESULTS	After adjustment for race , medical history , bystander CPR and prior adrenaline given , more participants survived to hospital admission with vasopressin ( 22.2 % ) than with adrenaline ( 16.7 % ) ( p = 0.05 , RR = 1.43 , 95 % CI = 1.02-2 .04 ) .\
RESULTS	Sub-group analysis suggested improved outcomes for vasopressin in participants with prolonged arrest times .\
CONCLUSIONS	Combination of vasopressin and adrenaline did not improve long term survival but seemed to improve survival to admission in patients with prolonged cardiac arrest .\
CONCLUSIONS	Further studies on the effect of vasopressin combined with therapeutic hypothermia on patients with prolonged cardiac arrest are needed .\
\
###20485146\
OBJECTIVE	We report the first randomized trial of laparoscopically assisted versus open colorectal resection for endometriosis focusing on perioperative complications , improvement in symptoms , quality of life , and fertility .\
BACKGROUND	Bowel endometriosis is one of the most severe forms of endometriosis .\
BACKGROUND	Although laparoscopically assisted surgery is a validated technique for colorectal cancer , there are serious concerns about its appropriateness for endometriosis in young women wishing to conceive because it is almost invariably a traumatic procedure .\
METHODS	We conducted a noninferiority trial and randomly assigned 52 patients with colorectal endometriosis to undergo laparoscopically assisted or open colorectal resection .\
METHODS	The median follow-up was 19 months .\
METHODS	The primary end point was improvement in dyschesia .\
RESULTS	Overall , a significant improvement in digestive symptoms ( dyschesia P < 0.0001 , diarrhea P < 0.01 , and bowel pain and cramping P < 0.0001 ) , gynecologic symptoms ( dysmenorrhea P < 0.0001 and dyspareunia P < 0.0001 ) , and general symptoms ( back pain P = 0.001 and asthenia P = 0.0001 ) was observed .\
RESULTS	No difference in the symptom delta values and quality of life was noted between the groups .\
RESULTS	Median blood loss was lower in the laparoscopic group ( P < 0.05 ) .\
RESULTS	Total number of complications was higher in the open surgery group ( P = 0.04 ) , especially grade 3 ( P = 0.03 ) .\
RESULTS	Pregnancy rate was higher in the laparoscopic group ( P = 0.006 ) , and the cumulative pregnancy rate was 60 % .\
CONCLUSIONS	Our findings support that laparoscopy is a safe option for women requiring colorectal resection for endometriosis .\
CONCLUSIONS	Moreover , laparoscopy offers a higher pregnancy rate than open surgery with similar improvements in symptoms and in quality of life .\
\
###22668800\
OBJECTIVE	In chronic obstructive pulmonary disease ( COPD ) , cardiovascular system is involved but less is known about role of specific cardiac biomarkers .\
OBJECTIVE	We aimed to investigate associations between N-terminal pro B-type natriuretic peptide ( NT-proBNP ) and troponin T during hospitalisation with 6-month outcome .\
METHODS	This was a prospective study conducted in consecutive patients hospitalized for an acute exacerbation of COPD .\
METHODS	On admission , and at discharge , NT-proBNP and troponin T were measured , and echocardiography was performed .\
METHODS	Hospitalisations and mortality were recorded for 6 months after discharge .\
RESULTS	We included 127 patients ( 70 10 years , 70 % men , GOLD III/IV 87 % ) .\
RESULTS	Left ventricular dysfunction was detected in 70 ( 55 % ) patients and diastolic dysfunction was the most common type ( 53 patients-42 % ) .\
RESULTS	NT-proBNP and troponin T were elevated on admission in 60 % and 36 % , and at discharge in 28 % and 19 % of patients .\
RESULTS	During follow-up , 53 ( 42 % ) patients were hospitalized and 17 ( 13 % ) patients died .\
RESULTS	In Kaplan Meier analysis of survival curves , NT-proBNP on admission distinguished between deceased and surviving patients ( p = 0.011 ) whilst troponin T at discharge separated hospitalized and non-hospitalized patients ( p = 0.017 ) .\
RESULTS	The adjusted Cox proportional hazard model confirmed these findings : discharge troponin T predicted hospitalisations ( hazard ratio 2.89 , 95 % confidence interval 1.13-7 .36 ) and admission NT-proBNP predicted mortality ( hazard ratio 4.20 , 95 % confidence interval 1.07-14 .01 ) .\
CONCLUSIONS	Elevated NT-proBNP at discharge and troponin T on admission predict outcome in patients hospitalized for an acute exacerbation of COPD .\
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###24588932\
BACKGROUND	Irritable bowel syndrome ( IBS ) is characterized by heterogeneous pathophysiology and low response to treatment .\
BACKGROUND	Up to 60 % of IBS patients suffers from visceral hypersensitivity , which is associated with symptom severity and underlying pathophysiological mechanisms .\
BACKGROUND	Recently , positive effects of probiotics in IBS have been reported , but overall the response was modest .\
BACKGROUND	We performed a study in IBS patients , characterized by visceral hypersensitivity measured with the rectal barostat , aiming to assess the effect of 6weeks of multispecies probiotic mix on visceral pain perception .\
METHODS	We conducted a randomized , placebo-controlled , double-blind trial in forty Rome III IBS patients with visceral hypersensitivity .\
METHODS	Prior to intake , patients kept a 2-week symptom diary and underwent a rectal barostat measurement .\
METHODS	When hypersensitivity was confirmed , participation was allowed and patients received a multispecies probiotic with in vitro proven potential beneficial effects on mechanisms contributing to visceral hypersensitivity ( six different probiotic strains ; 10 ( 9 ) cfu/g ) , or a placebo product of one sachet ( 5g ) per day for 6weeks .\
METHODS	At the end of the intervention period , visceroperception and symptoms were reassessed .\
RESULTS	Thirty-five patients completed the trial .\
RESULTS	The percentage of patients with visceral hypersensitivity decreased significantly in the probiotic and placebo group ( 76.5 % and 71.4 % , respectively ; N.S. between groups ) .\
RESULTS	Improvement in pain scores and mean symptom score did not differ between the probiotic and placebo group .\
CONCLUSIONS	In this placebo-controlled trial in IBS patients with visceral hypersensitivity , no significant effect of a multispecies probiotic on viscerperception was observed .\
CONCLUSIONS	The study has been registered in the US National Library of Medicine ( http://www.clinicaltrials.gov , NCT00702026 ) .\
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###11195960\
BACKGROUND	The premenopause period is that which precedes the actual menopause , when a decrease of the ovarian hormones is present , leading to cardiovascular diseases as arterial hypertension , acute myocardial infarction and cerebrovascular diseases .\
OBJECTIVE	We evaluated the antihypertensive response of the estradiol-medroxyprogesterone , to reduce arterial pressure in the premenopausal patient .\
METHODS	In a clinical trial from March 1997 to September 1998 , 106 patients with systemic hypertension , symptoms hypoestrogenism and estradiol levels less than 30 pg/mL were evaluated .\
METHODS	They were randomized at a trial in two groups with pursuit of 6 months .\
METHODS	Group A : 53 with captopril , Group B : 53 with estradiol-medroxyprogesterone .\
METHODS	The arterial pressure , cholesterol , triglycerides and symptoms hypoestrogenism were analyzed before and after the treatment .\
METHODS	The statistical analysis was performed with Student T.\
RESULTS	A decrease of arterial pressure was observed with estradiol , the same as with captopril with a p < 0.05 .\
RESULTS	Decrease of cholesterol and triglycerides were more significant in the estradiol group with a p < 0.05 .\
RESULTS	A bigger attenuation of symptoms of the hypoestrogenism existed in the estradiol group .\
CONCLUSIONS	The antihypertensive response with estradiol was the same as with captopril in the premenopausal patient with systemic hypertension .\
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###17937689\
OBJECTIVE	The aim of the study was to evaluate the efficacy of a milk product containing probiotics and prebiotics ( CUPDAY Milk ) on the incidence of diarrhoea in children attending daycare centres .\
METHODS	The study was undertaken in a randomized controlled trial with 496 children aged 1-3 years attending 29 childcare centres in Perth , Australia .\
METHODS	The endpoint for the study was the number of days in which children were recorded as having four or more stools .\
METHODS	The diarrhoeal rates were analyzed by Poisson regression using ` intention to treat ' ( all children ) and ` reduced ' ( children enrolled for more than 10 days ) data sets .\
RESULTS	There was no difference in demographic characteristics between the case and control groups .\
RESULTS	In the ` intention to treat ' analysis , a total of 41 745 child-days were included in the study .\
RESULTS	The adjusted risk ratio for those consuming the ` Cupday ' milk drink was 0.82 ( 95 % CI 0.73-0 .94 ) for the intention to treat sample ( n = 496 ) and 0.80 ( 95 % CI 0.70-0 .91 ) for the reduced sample ( n = 315 ) .\
RESULTS	The children consuming the ` Cupday ' drink had a 20 % reduction in the number of days experiencing four or more stools per day .\
CONCLUSIONS	A milk containing probiotics and prebiotics reduced the number of days children attending child care who had four or more stools by 20 % .\
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###18723857\
BACKGROUND	Relationships between plasma morphine concentrations and neonatal responses to endotracheal tube ( ETT ) suctioning are unknown in preterm neonates .\
METHODS	Ventilated preterm neonates ( n = 898 ) from 16 centres were randomly assigned to placebo ( n = 449 ) or morphine ( n = 449 ) .\
METHODS	After an i.v. loading dose ( 100 microg kg ( -1 ) ) , morphine infusions [ 23-26 weeks postmenstrual age ( PMA ) 10 microg kg ( -1 ) h ( -1 ) ; 27-29 weeks 20 microg kg ( -1 ) h ( -1 ) ; and 30-32 weeks 30 microg kg ( -1 ) h ( -1 ) ] were established for a maximum of 14 days .\
METHODS	Open-label morphine ( 20-100 microg kg ( -1 ) ) was given for pain or agitation .\
METHODS	Morphine assay and neonatal response to ETT suctioning was measured at 20-28 and 70-76 h after starting the drug infusion and at 10-14 h after discontinuation of the study drug .\
METHODS	The concentration-effect response was investigated using non-linear mixed effects models .\
RESULTS	A total of 5119 data points ( 1598 measured morphine concentrations and 3521 effect measures ) were available from 875 neonates for analysis .\
RESULTS	Clearance was 50 % that of the mature value at 54.2 weeks PMA ( CLmat ( 50 ) ) and increased from 2.05 litre h ( -1 ) 70 kg ( -1 ) at 24 weeks PMA to 6.04 litre h ( -1 ) 70 kg ( -1 ) at 32 weeks PMA .\
RESULTS	The volume of distribution in preterm neonates was 190 litre 70 kg ( -1 ) ( CV 51 % ) and did not change with age .\
RESULTS	There was no relationship between morphine concentrations ( range 0-440 microg litre ( -1 ) ) and heart rate changes associated with ETT suctioning or with the Premature Infant Pain Profile .\
CONCLUSIONS	A sigmoid curve describing maturation of morphine clearance is moved to the right in preterm neonates and volume of distribution is increased compared with term neonates .\
CONCLUSIONS	Morphine does not alter the neonatal response to ETT suctioning .\
\
###9585710\
OBJECTIVE	Flumazenil is a benzodiazepine receptor antagonist that has been reported to provoke panic attacks in patients with panic disorder .\
OBJECTIVE	This study was undertaken to compare the effects of flumazenil and sodium lactate , the most widely studied panic provocation agent .\
METHODS	Ten patients with panic disorder were given infusions of saline , sodium lactate , and flumazenil in randomized order .\
METHODS	Panic attacks , psychopathological changes , heart rate , and cortisol and ACTH secretion were recorded .\
RESULTS	Eight of the 10 patients experienced a panic attack after sodium lactate , but none did after flumazenil or saline .\
RESULTS	Cortisol and ACTH secretion were not enhanced by any of the treatments .\
RESULTS	Sodium lactate increased heart rate , whereas flumazenil had the opposite effect .\
CONCLUSIONS	These findings do not lend support to the view that the benzodiazepine receptors of lactate-susceptible patients with panic disorder are hypersensitive and that flumazenil can therefore act as an inverse agonist .\
\
###22997792\
OBJECTIVE	To explore the mechanism of acupotomy lysis in treatment of the third lumbar vertebrae transverse process syndrome .\
METHODS	One hundred and eighty patients were randomly assigned into an acupotomy group and an electroacupuncture ( EA ) group , 90 cases in each group .\
METHODS	The acupotomy group was treated with acupotomy on the tip of the 3rd lumbar vertebrae transverse process ( tender point ) combination with massage manipulation of hyperflexion and hyperextension on the waist , once a week for 3 weeks .\
METHODS	The EA group was treated with EA at bilateral Shenshu ( BL 23 ) , Yaoyangguan ( GV 3 ) , Ashi point ( local tender point ) and ipsilateral Weizhong ( BL 40 ) , 3 times a week for 3 weeks .\
METHODS	The 500 g pressure displacement and the energy absorption ratio were measured by JZL-II soft tissue tension meter and the clinical effect was evaluated by JOA low back pain scale before treatment , after treatment and 6 months after treatment .\
RESULTS	After treatment and at follow-up visit , the 500 g pressure displacement in the acupotomy group increased significantly ( both P < 0.01 ) , but it was decreased significantly in the EA group ( P < 0.05 , P < 0.01 ) .\
RESULTS	The energy absorption ratio in the acupotomy group after treatment and at follow-up visit increased significantly ( both P < 0.01 ) , and in the EA group , there was no significant difference after treatment as compared with that before treatment ( P > 0.05 ) , but it was increased significantly at follow-up visit ( P < 0.01 ) .\
RESULTS	The total therapeutic level distribution in the acupotomy group was better than that in the EA group after treatment and 6 months after treatment ( P < 0.05 , P < 0.01 ) .\
CONCLUSIONS	Acupotomy therapy can significantly increase the 500 g pressure displacement and the energy absorption ratio of the local soft tissue around the third lumbar vertebrae transverse process , decrease the local soft tissue tension so as to alleviate pain .\
CONCLUSIONS	The clinical effect of the acupotomy is superior to that of electroacupuncture .\
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###12854102\
BACKGROUND	The aim of this study was to compare the cost-effectiveness of four-layer compression bandaging for venous leg ulcers with that of other available treatments .\
METHODS	In this pragmatic trial , 200 patients with a venous leg ulcer were randomized either to four-layer bandaging ( intervention group ; n = 100 ) or to continue their usual system of care ( control group ; n = 100 ) .\
METHODS	The follow-up for each patient was 12 weeks .\
METHODS	Analysis was by intention to treat ; the main outcome measures were time to healing and cost to the health board per leg healed .\
RESULTS	Baseline characteristics were well matched in the two groups .\
RESULTS	The Kaplan-Meier estimate of the healing rate at 3 months was 54 per cent with four-layer bandaging and 34 per cent in the control group .\
RESULTS	Throughout the 3 months , four-layer bandaging healed leg ulcers significantly earlier ( P = 0.006 ) .\
RESULTS	There was a significant reduction in the median cost per leg healed with four-layer bandaging ( euro 210 versus euro 234 ; P = 0.040 ) .\
CONCLUSIONS	Four-layer bandaging is currently the most effective method of treating venous leg ulcers in a community setting .\
\
###15064584\
OBJECTIVE	The purpose of this study was to determine the effect of glycine-arginine-alpha-ketoisocaproic acid ( GAKIC ) supplementation on repeated bouts of anaerobic cycling performance .\
METHODS	Ten men completed a randomized , double-blinded , placebo-controlled exercise protocol of two sessions separated by 7 d. Plasma lactate was analyzed in blood collected 45 min before exercise ( REST ) and 5 min postexercise ( POST ) .\
METHODS	Subjects consumed either 11.2-g GAKIC or placebo ( PLC ) during a 45-min period between the REST and exercise .\
METHODS	Mean power , peak power , and fatigue values were assessed from five supramaximal , 10-s cycle ergometer sprints , separated by 1-min rest intervals .\
METHODS	Data were analyzed using repeated measures ANCOVA .\
RESULTS	A significant treatment x time interaction ( P = 0.039 ) was observed for the change in mean power output over the five sprints between the GAKIC and PLC treatments .\
RESULTS	Post hoc analyses revealed a greater retention of mean power ( P = 0.038 ) between sprints 1 and 2 after GAKIC ( -1 + / - 9 W ) versus PLC treatment ( -47 + / - 18 W ) .\
RESULTS	No other performance variables differed between PLC and GAKIC .\
RESULTS	POST lactate was increased ( P < 0.001 ) above REST , but there was no difference between treatments ( P = 0.936 ) .\
CONCLUSIONS	These data support an ergogenic effect of GAKIC for attenuating the decline in mean power during repeated bouts of supramaximal exercise .\
\
###12967799\
OBJECTIVE	To compare the long-term results of trabeculectomy and Ahmed glaucoma valve implant in the initial surgical management of primary open - and closed-angle glaucoma .\
METHODS	Randomized controlled clinical trial .\
METHODS	One eye each of consecutive patients with primary glaucoma and without prior intraocular surgery was randomized to receive either trabeculectomy or the Ahmed implant .\
METHODS	Large university-affiliated eye hospital in Columbo , Sri Lanka .\
RESULTS	Of 123 patients , 64 were randomized to trabeculectomy and 59 to the Ahmed implant .\
RESULTS	With a mean follow-up of 31 months , the trabeculectomy group had statistically lower intraocular pressures ( IOP ) during the first postoperative year .\
RESULTS	After the first year , the IOPs were comparable .\
RESULTS	No statistically significant differences between groups were noted for postoperative visual acuity , visual field , anterior chamber depth , and short-term or long-term complications .\
RESULTS	Adjunctive medication requirement was comparable for both groups .\
RESULTS	The cumulative probabilities of success ( IOP < 21 mm Hg and at least 15 % reduction in IOP from preoperative levels ) at the final follow-up period ( months , 41-52 ) were 68.1 % for trabeculectomy and 69.8 % for Ahmed implant ( P = .86 ) .\
CONCLUSIONS	Lower IOPs were noted for the trabeculectomy group during the first year .\
CONCLUSIONS	With longer follow-up , the IOPs and the cumulative probabilities of success were comparable between the two groups .\
\
###15919639\
OBJECTIVE	The purpose of this study was to determine the frequency and effectiveness of behavioral goal choices in the self-management of diabetes and to test goal-setting theory hypotheses that self-selection and behavioral specificity of goals are key to enhancing persistence .\
METHODS	Participants with type 2 diabetes in a randomized controlled trial ( n = 422 ) completed baseline behavioral assessments using a clinic-based , interactive , self-management CD-ROM that allowed them to select a behavioral goal and receive mail and telephone support for the initial 6 months of the trial followed by additional behavioral assessments .\
METHODS	Frequency of behavioral goal selection and 6-month behavioral data were collected .\
RESULTS	Approximately 49 % , 27 % , and 24 % of the participants , respectively , set goals to increase physical activity ( PA ) , reduce fat intake , or increase fruits and vegetables ( F&V ) consumed .\
RESULTS	At baseline , participants who selected PA , reduced fat consumption , or F&V were significantly , and respectively , less active , consumed more dietary fat , and ate fewer F&V regardless of demographic characteristics .\
RESULTS	Participants who selected a reduced-fat goal showed a significantly larger decrease than did those that selected PA or F&V goals .\
RESULTS	Participants who selected an F&V goal showed significant changes in F&V consumption .\
RESULTS	Participants who selected a PA goal demonstrated significant changes in days of moderate and vigorous physical activity .\
CONCLUSIONS	When participants are provided with information on health behavior status and an option of behavioral goals for managing type 2 diabetes , they will select personally appropriate goals , resulting in significant behavioral changes over a 6-month period .\
\
###23190342\
BACKGROUND	IncobotulinumtoxinA has been approved for treatment of glabellar frown lines ( GFL ) in the United States , all major European markets , South Korea , and Argentina and in Russia and Mexico for the treatment of mimic wrinkles and hyperkinetic facial lines , respectively .\
OBJECTIVE	Prospective , 2-year , open-label , multicenter , repeat-dose , Phase III trial investigating the safety and efficacy of incobotulinumtoxinA for the treatment of GFL .\
METHODS	Subjects with moderate or severe GFL on the Facial Wrinkle Scale ( FWS ) , enrolled from previous trials , were treated with 20U of incobotulinumtoxinA per cycle ( up to eight treatment cycles , treatment interval at least 85days ) .\
METHODS	Efficacy was measured according to the investigator-assessed percentage of responders on the FWS ( subjects with a score of 0 or 1 ) at rest and maximum frown on Day 30 of each cycle , subject assessments , and onset and duration of treatment effect .\
RESULTS	In 796 subjects , 77 % to 88 % were responders at rest , and 79 % to 90 % were responders at maximum frown .\
RESULTS	Onset was rapid ; subjects reported effects in the first few days after treatment .\
RESULTS	No new tolerability or safety concerns were reported .\
CONCLUSIONS	IncobotulinumtoxinA injections were well tolerated and resulted in efficacy in the treatment of GFL for up to 2years .\
\
###8053591\
BACKGROUND	The power spectrum of the electroencephalogram ( EEG ) may be analyzed to provide quantitative measures of EEG activity ( e.g. , spectral edge , which defines the highest EEG frequency at which significant activity is found ) .\
BACKGROUND	The current study tested the hypothesis that spectral edge and similar measures distinguish different functional depths of anesthesia in humans .\
METHODS	Three groups were studied .\
METHODS	Group 1 consisted of 34 surgical patients ( ASA physical status 1 or 2 ) who received 0.6 , 1.0 and 1.4 MAC isoflurane anesthesia .\
METHODS	A subgroup ( group 2 ) of group 1 was tested during 1.0 MAC isoflurane anesthesia at surgical incision .\
METHODS	Group 3 consisted of 16 volunteers who listened to an audiotape while receiving 0.15 , 0.3 , and 0.45 MAC isoflurane or 0.3 , 0.45 , and 0.6 MAC nitrous oxide in oxygen .\
METHODS	The audiotape contained information designed to test implicit and explicit memory formation .\
METHODS	We tested the ability of six EEG parameters ( spectral-edge , 95th percentile power frequency , median power , and zero crossing frequencies and total power in the alpha - [ 8-13 Hz ] and delta - [ < 4 Hz ] power ranges ) to predict movement after surgical incision , purposeful response to command , or memory of information presented during anesthetic administration .\
RESULTS	Isoflurane decreased EEG activity in group 1 in a dose-related fashion .\
RESULTS	The 55 % of group 2 who made purposeful movements in response to incision did not differ in their EEG from nonresponders ( e.g. , spectral edge 19.8 + / - 3.1 vs. 19.3 + / - 2.6 Hz , mean + / - SD ) .\
RESULTS	In group 3 , memory of the information presented did not correlate with values of any EEG parameter .\
RESULTS	Response to verbal command was associated with lower anesthetic concentrations and with smaller alpha - and delta-band power ( 298 + / - 66 vs. 401 + / - 80 watts ; and 75 + / - 20 vs. 121 + / - 49 watts , mean + / - SD ) , but there was no difference in values for other parameters .\
CONCLUSIONS	We conclude that our EEG measures do not predict depth of anesthesia as defined by the response to surgical incision , the response to verbal command or the development of memory .\
\
###18474811\
BACKGROUND	Interleukin-1 increases nitrooxidative stress .\
BACKGROUND	We investigated the effects of a human recombinant interleukin-1a receptor antagonist ( anakinra ) on nitrooxidative stress and vascular and left ventricular function .\
RESULTS	In an acute , double-blind trial , 23 patients with rheumatoid arthritis were randomized to receive a single injection of anakinra ( 150 mg s.c. ) or placebo and , after 48 hours , the alternative treatment .\
RESULTS	At baseline and 3 hours after the injection , we assessed ( 1 ) coronary flow reserve , aortic distensibility , systolic and diastolic ( Em ) velocity of the mitral annulus , and E to Em ratio ( E/Em ) using echocardiography ; ( 2 ) flow-mediated , endothelium-dependent dilation of the brachial artery ; and ( 3 ) malondialdehyde , nitrotyrosine , interleukin-6 , endothelin-1 , and C-reactive protein .\
RESULTS	In a chronic , nonrandomized trial , 23 patients received anakinra and 19 received prednisolone for 30 days , after which all indices were reassessed .\
RESULTS	Compared with baseline , there was a greater reduction in malondialdehyde , nitrotyrosine , interleukin-6 , and endothelin-1 and a greater increase in flow-mediated dilation , coronary flow reserve , aortic distensibility , systolic velocity of mitral annulus , and E/Em after anakinra than after placebo ( malondialdehyde -25 % versus 9 % ; nitrotyrosine -38 % versus -11 % ; interleukin-6 -29 % versus 0.9 % ; endothelin-1 -36 % versus -11 % ; flow-mediated dilation 45 % versus -9 % ; coronary flow reserve 29 % versus 4 % ; and aortic distensibility 45 % versus 2 % ; P < 0.05 for all comparisons ) .\
RESULTS	After 30 days of treatment , the improvement in biomarkers and in vascular and left ventricular function was greater in the anakinra group than in the prednisolone group ( P < 0.05 ) .\
CONCLUSIONS	Interleukin-1 inhibition improves vascular and left ventricular function and is associated with reduction of nitrooxidative stress and endothelin .\
\
###18714152\
OBJECTIVE	It was the aim of this study to evaluate the effect of oral L-carnitine administration on insulin sensitivity and lipid profile in subjects with type 2 diabetes mellitus .\
METHODS	A randomized , double-blind , placebo-controlled clinical trial was carried out in 12 subjects with type 2 diabetes .\
METHODS	Six subjects received L-carnitine 1 g orally 3 times a day before meals for a period of 4 weeks .\
METHODS	Six other individuals took a placebo for the same period of time , as the control group .\
METHODS	Before and after the intervention , insulin sensitivity and the lipid profile were estimated .\
METHODS	To assess insulin sensitivity , the euglycemic-hyperinsulinemic clamp technique was performed .\
METHODS	Wilcoxon 's signed rank and the Mann-Whitney U test were used for the statistical analyses .\
RESULTS	There were no significant differences in basal clinical characteristics between the 2 groups .\
RESULTS	Insulin sensitivity and the basal lipid profile were similar .\
RESULTS	There were no significant changes in either group after the intervention in insulin sensitivity ( 3.2 + / - 1.2 vs. 4.5 + / - 1.7 mg/kg/min , p = 0.115 , and 3.5 + / - 0.6 vs. 3.5 + / - 0.4 mg/kg/min , p = 0.917 , for the placebo and L-carnitine groups , respectively ) and in lipid profile .\
CONCLUSIONS	L-Carnitine orally administered for a period of 4 weeks did not modify insulin sensitivity or the lipid profile .\
\
###25650633\
OBJECTIVE	The comparative incidences of hemidiaphragmatic paralysis associated with contemporary ultrasound-guided supraclavicular versus infraclavicular blockade have not received extensive study .\
OBJECTIVE	We tested the hypothesis that the infraclavicular approach results in a lower incidence of hemidiaphragmatic paralysis compared with supraclavicular blockade when a standard local anesthetic volume and concentration are used .\
METHODS	With institutional human ethics board approval , we enrolled 64 patients undergoing right-sided upper extremity surgery in a randomized , blinded , parallel-group trial .\
METHODS	Patients were assigned to ultrasound-guided supraclavicular or infraclavicular blockade with 30 mL of 0.5 % ropivacaine .\
METHODS	The primary end point was complete hemidiaphragmatic paralysis at 30 minutes , defined as a greater than 75 % reduction in diaphragmatic excursion measured with the voluntary sniff test using M-mode ultrasonography .\
METHODS	Partial paralysis was defined as a 25 % to 75 % reduction .\
RESULTS	Eleven ( 34 % ) of 32 patients in the supraclavicular group versus 1 ( 3 % ) of 32 in the infraclavicular group had complete hemidiaphragmatic paralysis ( P = 0.001 [ 1-tailed ] ; relative risk , 11.0 [ 95 % confidence interval , 1.5-80 .3 ] ) ; 44 % versus 13 % had any ( complete or partial ) paralysis ( P = 0.006 ; relative risk , 3.5 [ 95 % confidence interval , 1.3-9 .5 ] ) .\
RESULTS	Eight ( 25 % ) of 32 patients in the supraclavicular group versus 5 ( 16 % ) of 32 in the infraclavicular group reported dyspnea ( P = 0.54 ) .\
CONCLUSIONS	Ultrasound-guided supraclavicular blockade with 30 mL of 0.5 % ropivacaine produced complete hemidiaphragmatic paralysis in approximately one-third of patients .\
CONCLUSIONS	The infraclavicular approach greatly reduced this risk but did not eliminate it .\
CONCLUSIONS	These data may aid in the selection of the approach to brachial plexus blockade , particularly in ambulatory patients and/or those with respiratory comorbidities .\
\
###12606904\
BACKGROUND	Several studies relating electroencephalogram parameter values to clinical endpoints using a single ( mostly hypnotic ) drug at relatively low levels of central nervous system depression ( sedation ) have been published .\
BACKGROUND	However , the usefulness of a parameter derived from the electroencephalogram for clinical anesthesia largely depends on its ability to predict the response to stimuli of different intensity or painfulness under a combination of a hypnotic and an ( opioid ) analgesic .\
BACKGROUND	This study was designed to evaluate the predictive performance of spectral edge frequency 95 ( SEF95 ) , BIS , and approximate entropy for the response to increasingly intense stimuli under different concentrations of both propofol and remifentanil in the therapeutic range .\
METHODS	Ten healthy male and ten healthy female volunteers were studied during coadministration of propofol and remifentanil .\
METHODS	After having maintained a specific target concentration for 10 min , the depth of sedation-anesthesia was assessed using the responsiveness component of the Observer 's Assessment of Alertness/Sedation ( OAA/S ) rating scale , which was modified by adding insertion of a laryngeal mask and laryngoscopy .\
METHODS	The electroencephalogram derived parameters approximate entropy , bispectral index , and SEF95 were recorded just before sedation level was assessed .\
RESULTS	The prediction probability values for approximate entropy were slightly , but not significantly , better than those for bispectral index , SEF95 , and the combination of drug concentrations .\
RESULTS	A much lower prediction ability was observed for tolerance of airway manipulation than for hypnotic endpoints .\
CONCLUSIONS	Approximate entropy revealed informations on hypnotic and analgesic endpoints using coadministration of propofol and remifentanil comparable to bispectral index , SEF95 , and the combination of drug concentrations .\
\
###22243034\
BACKGROUND	Functional dyspepsia ( FD ) is a common disease without an established optimal treatment .\
OBJECTIVE	To determine ( i ) the effect of acupuncture in relieving FD symptoms and improving life quality ; ( ii ) the effect difference between acupoint and non-acupoint ; and ( iii ) the effect difference among different acupoints .\
METHODS	A total of 712 eligible patients were included and randomly assigned to six groups ( Group A : specific acupoints of the stomach meridian ; Group B : non-specific acupoints of the stomach meridian ; Group C : specific acupoints of alarm and transport points ; Group D : specific acupoints of the gallbladder meridian ; Group E : sham acupuncture of non-acupoints ; and Group F : itopride ) .\
METHODS	A treatment period of 4 weeks ( continuous five sessions per week ) , and a follow-up period of 12 weeks were arranged .\
METHODS	The outcomes were the ( i ) patients ' response , ( ii ) symptoms improvement measured using the Symptom Index of Dyspepsia and ( iii ) quality-of-life improvement based on Nepean Dyspepsia Index .\
RESULTS	All groups had an improvement in dyspepsia symptoms and the QoL at the end of treatment , and the improvement was sustained for 4 weeks and 12 weeks .\
RESULTS	The overall response rate was significantly higher in acupuncture group A ( 70.69 % ) , and lower in sham acupuncture group ( 34.75 % ) , compared with itopride and other acupuncture groups .\
RESULTS	Similarly , the difference in symptoms and QoL improvement was significant between group A and the other acupuncture groups .\
CONCLUSIONS	Acupuncture is effective in the treatment of functional dyspepsia , and is superior to non-acupoint puncture .\
CONCLUSIONS	The benefit of acupuncture relies on acupoint specificity .\
\
###9172027\
OBJECTIVE	To investigate the effects of priming rocuronium on the time course of neuromuscular blockade .\
METHODS	Prospective , controlled , randomized clinical study .\
METHODS	University teaching hospital .\
METHODS	42 ASA physical status I and II patients undergoing peripheral surgery with general anesthesia .\
METHODS	Following a standardized propofol-fentanyl induction , patients in Group 1 ( n = 21 ) received a priming dose of rocuronium 0.06 mg/kg followed two minutes later by an intubating dose of rocuronium 0.54 mg/kg .\
METHODS	Patients in Group 2 ( n = 21 ) received a saline placebo injection followed two minutes later by rocuronium 0.6 mg/kg .\
METHODS	Anesthesia was maintained with isoflurane and nitrous oxide 60 % in oxygen .\
RESULTS	Neuromuscular function was assessed at the wrist using mechanomyography with a single-twitch mode of stimulation at a frequency of 1 Hz until tracheal intubation and at 0.1 Hz thereafter .\
RESULTS	The times from injection of the intubating dose of rocuronium until 95 % suppression of the twitch tension ( onset time ) , recovery of twitch tension to 25 % of control ( clinical duration of action ) , and the time from 25 % to 75 % spontaneous recovery of twitch tension ( recovery index ) were recorded .\
RESULTS	The trachea was intubated at 95 % depression of the twitch tension and the intubating conditions were graded using a 3-point scale .\
RESULTS	The onset times with priming rocuronium ( 34 + / - 6 s ) were significantly shorter ( p < 0.01 ) than those without priming ( 59 + / - 14 s ) .\
RESULTS	The intubation conditions were similar in the two groups ; however , the intubating times with priming were significantly shorter .\
RESULTS	The clinical duration of action and the recovery index did not differ significantly between the two groups .\
CONCLUSIONS	Priming rocuronium decreased the onset times and thus , the intubating times without increasing the clinical duration of action or recovery index .\
\
###18161210\
OBJECTIVE	There have been no endpoint studies with statins for patients with severe renal failure .\
OBJECTIVE	The purpose of this prospective , open , randomized , controlled study was to investigate whether atorvastatin ( 10 mg/day ) would alter cardiovascular endpoints and the overall mortality rate of patients with chronic kidney disease stage 4 or 5 ( creatinine clearance < 30 ml/min ) .\
METHODS	The study subjects comprised 143 patients who were randomized either to placebo ( controls ; n = 73 ; mean age 69.5 years ) or to treatment with atorvastatin ( n = 70 ; mean age 67.9 years ) .\
METHODS	The patients included were either non-dialysis ( n = 33 ) , haemodialysis ( n = 97 ) or peritoneal dialysis ( n = 13 ) patients .\
METHODS	Analysis focused on the primary endpoints of all-cause mortality , non-lethal acute myocardial infarction , coronary artery bypass graft surgery and percutaneous transluminal coronary angioplasty .\
METHODS	Statistical analysis for endpoint data was mainly by intention-to-treat .\
RESULTS	Primary endpoints occurred in 74 % of the subjects .\
RESULTS	There was no difference in outcome between the control and atorvastatin groups .\
RESULTS	The 5-year endpoint-free survival rate from study entry was 20 % .\
RESULTS	Atorvastatin was withdrawn in 20 % of patients due to unacceptable side-effects .\
RESULTS	In the atorvastatin group , low-density lipoprotein ( LDL ) cholesterol was reduced by 35 % at 1 month and then sustained .\
RESULTS	The controls showed a progressive reduction in LDL cholesterol until 36 months .\
CONCLUSIONS	Although atorvastatin reduced total and LDL cholesterol effectively it was not beneficial regarding the long-term outcomes of cardiovascular endpoints or survival .\
CONCLUSIONS	In contrast to other patient groups , patients with severe chronic kidney disease , especially those on dialysis , seem to derive limited benefit from this lower dose of atorvastatin .\
\
###22349808\
OBJECTIVE	Amuvatinib is a multi-targeted tyrosine kinase inhibitor with activity that also disrupts DNA damage repair through suppression of homologous recombination protein Rad51 .\
OBJECTIVE	Amuvatinib dry-powder capsules ( DPC ) showed evidence of activity in early Phase 1 cancer studies but low systemic exposure .\
OBJECTIVE	The purposes of the studies were to investigate the cause of low exposure , develop , and test an alternative formulation with improved exposure , and establish the dose to be tested in future studies in cancer patients .\
METHODS	Three studies were conducted in a total of 58 healthy subjects : a food-effect study using amuvatinib DPC , a single-dose pharmacokinetic study comparing amuvatinib DPC to a new lipid-suspension capsules ( LSC ) , and a multiple-dose pharmacokinetic study using amuvatinib LSC .\
RESULTS	A high-fat meal administered with amuvatinib DPC increased the rate and extent of absorption compared to the Fasted state , a 183 and 118 % increase in the mean C ( max ) and AUC ( 0 - ) of amuvatinib , respectively .\
RESULTS	The single-dose pharmacokinetics of amuvatinib LSC resulted in an approximately two-third-fold increased exposure ( AUC ) compared with amuvatinib DPC .\
RESULTS	The multiple-dose pharmacokinetics of the amuvatinib LSC 300 mg administered every 8 h exhibited improved accumulation compared with the 12-h regimens and achieved presumed therapeutic level safely with no serious or severe adverse events reported .\
RESULTS	No subject discontinued treatment due to an adverse event .\
CONCLUSIONS	Amuvatinib LSC , 300 mg every 8 h , is being studied in cancer patients based on the improved exposure and similar safety profile to amuvatinib DPC .\
CONCLUSIONS	A lipid-based formulation approach may be a useful tool for other low aqueous soluble compounds .\
\
###24274836\
BACKGROUND	The management of psychiatric inpatients exhibiting severely disturbed and aggressive behaviour is an important educational topic .\
BACKGROUND	Well structured , IT-based educational programmes ( eLearning ) often ensure quality and may make training more affordable and accessible .\
OBJECTIVE	The aim of this study was to explore the impact of an eLearning course for personnel on the rates and duration of seclusion and mechanical restraint among psychiatric inpatients .\
METHODS	In a cluster-randomized intervention trial , the nursing personnel on 10 wards were randomly assigned to eLearning ( intervention ) or training-as-usual ( control ) groups .\
METHODS	The eLearning course comprised six modules with specific topics ( legal and ethical issues , behaviour-related factors , therapeutic relationship and self-awareness , teamwork and integrating knowledge with practice ) and specific learning methods .\
METHODS	The rates ( incidents per 1000 occupied bed days ) and durations of the coercion incidents were examined before and after the course .\
RESULTS	A total of 1283 coercion incidents ( 1143 seclusions [ 89 % ] and 140 incidents involving the use of mechanical restraints [ 11 % ] ) were recorded on the study wards during the data collection period .\
RESULTS	On the intervention wards , there were no statistically significant changes in the rates of seclusion and mechanical restraint .\
RESULTS	However , the duration of incidents involving mechanical restraints shortened from 36.0 to 4.0 h ( median ) ( P < 0.001 ) .\
RESULTS	No statistically significant changes occurred on the control wards .\
CONCLUSIONS	After our eLearning course , the duration of incidents involving the use of mechanical restraints decreased .\
CONCLUSIONS	However , more studies are needed to ensure that the content of the course focuses on the most important factors associated with the seclusion-related elements .\
CONCLUSIONS	The eLearning course deserves further development and further studies .\
CONCLUSIONS	The duration of coercion incidents merits attention in future research .\
\
###15381507\
OBJECTIVE	to determine the effect of risk factor modification and balance exercise on falls rates in residential care homes .\
METHODS	cluster randomised controlled trial .\
METHODS	196 residents ( aged 60 years or over ) in 20 residential care homes were enrolled ( 38 % response rate ) .\
METHODS	Homes were randomly allocated to intervention and control arms .\
METHODS	A total of 102 residents were consigned to the intervention arm and 94 to the control arm .\
METHODS	a multifactorial falls prevention programme including 3 months gait and balance training , medication review , podiatry and optometry .\
METHODS	number of falls/recurrent falls per person , number of medications per person , and change in Tinetti gait and balance measure .\
RESULTS	in the intervention group there was a mean of 2.2 falls per resident per year compared with 4.0 in the control group ; this failed to reach statistical significance ( P = 0.2 ) once the intra-cluster correlation ( ICC , 0.10 ) had been accounted for .\
RESULTS	Several risk factors were reduced in the intervention arm .\
CONCLUSIONS	falls risk factor reduction is possible in residents of care homes .\
CONCLUSIONS	A modest reduction in falls rates was demonstrated but this failed to reach statistical significance .\
\
###24376248\
OBJECTIVE	To determine the level of agreement and potential impact on disease-modifying antirheumatic drug ( DMARD ) escalation decisions and of adding musculoskeletal ultrasound ( MSUS ) assessment of disease activity to the Disease Activity Score in 28 joints ( DAS28 ) in early rheumatoid arthritis ( RA ) .\
METHODS	Data were gathered from 53 early RA patients randomized to the MSUS assessment group of the Targeting Synovitis in Early Rheumatoid Arthritis study .\
METHODS	DAS28 scores were calculated every month .\
METHODS	MSUS was performed on patients with low disease activity ( DAS28 < 3.2 ) and on those with moderate disease activity ( 3.2 DAS28 < 5.1 ) without clinically swollen joints ( swollen joint count [ SJC ] 1 ) .\
METHODS	Fourteen joints ( bilateral proximal interphalangeal joints 2 and 3 , metacarpophalangeal [ MCP ] joints 2 and 3 , the radiocarpal , and metatarsophalangeal joints 2 and 5 ) were examined .\
METHODS	Active disease was defined as 2 joints demonstrating any power Doppler ( PD ) signal .\
METHODS	Data from 414 paired DAS28 and MSUS assessments were pooled to determine the level of agreement between each method .\
RESULTS	A total of 369 MSUS assessments were conducted on patients with DAS28 < 3.2 ; 92 ( 25 % ) of these assessments identified active disease .\
RESULTS	A total of 271 MSUS assessments were performed on those with DAS28 < 2.6 ; 66 ( 24 % ) of these identified active disease .\
RESULTS	Forty-five MSUS assessments were conducted on patients with 3.2 DAS28 < 5.1 and SJC 1 ; 15 ( 33 % ) of these assessments confirmed active disease .\
RESULTS	On 120 occasions ( 29 % ) , MSUS findings contradicted the DAS28 and led to modified treatment decisions .\
RESULTS	The joints that most frequently exhibited PD signal were radiocarpal and index and middle MCP joints .\
CONCLUSIONS	Compared to the DAS28 , global RA disease activity assessment using a limited MSUS joint set provided additional disease activity information and led to altered treatment decisions in a significant minority of occasions .\
CONCLUSIONS	This may allow further tailoring of DMARD therapy by supporting DMARD escalation in patients with continuing subclinical synovitis and preventing escalation in symptomatic patients with minimal clinical and/or ultrasonographic synovitis .\
\
###22245162\
OBJECTIVE	To examine the effect of bench step exercise on arterial pulse wave velocity ( PWV ) and the associated contribution of insulin-like growth factor ( IGF ) -1 bioactivity and nitric oxide ( NO ) .\
METHODS	Twenty-six elderly ( post-menopausal ) women were randomly allocated to a bench step exercise group or a control group .\
METHODS	The participants in the bench step exercise group practiced a 12-week home-based bench step exercise for 10-20min , 3 times daily ( i.e. , for a total of 140min/week at the intensity level of lactate threshold ( LT ) ) .\
METHODS	In addition to conventional risk factors of atherosclerosis , PWV , IGF-1 / IGF binding protein ( IGFBP ) -3 molar ratio ( an index for IGF-1 bioactivity ) , and urinary nitrite/nitrate ( NO ( x ) ) excretion were measured before and after the intervention .\
RESULTS	BMI , systolic blood pressure , fasting plasma glucose , low-density lipoprotein cholesterol , LT , and PWV were significantly improved in the bench step exercise group .\
RESULTS	A significant positive correlation between changes in PWV and IGF-1 / IGFBP-3 molar ratio , and a significant negative correlation between changes in IGF-1 / IGFBP-3 molar ratio and urinary NO ( x ) excretion were found in the bench step exercise group .\
CONCLUSIONS	The bench step exercise leads to improvements in not only the classical risk factors of atherosclerosis but also the arterial stiffness in elderly women , partly through NO production via IGF-1 bioactivity .\
\
###15742795\
OBJECTIVE	The relationship between maternal depression and child behavior problems has been consistently demonstrated , but not the impact of child behavior problems on maternal depression .\
METHODS	Mothers of 3 - to 6-year-old children ( N = 69 ) reported regarding their depression , parenting competence , attachment to the child , the child 's impact on the family , and behavior problems .\
RESULTS	Child behavior problems were positively associated with maternal depression , an association explained by mediating variables : impact of the child on the family , mother 's parenting competence , and attachment to the child .\
CONCLUSIONS	Maternal depression should be considered when providing clinical services to children , given the potential for exacerbation of symptoms in the face of child behavior problems .\
\
###8250615\
OBJECTIVE	To test the hypothesis that colchicine is an effective treatment of psoriatic arthritis .\
METHODS	Twenty five patients with psoriatic arthritis were entered into a two centre , double blind , crossover study of 23 weeks ' duration comparing the therapeutic effect of colchicine ( 0.6-1 .8 mg/day ) with placebo .\
RESULTS	No significant difference was noted between colchicine or placebo treatment for the primary outcome measure ( Lansbury joint count ) or any of the seven secondary outcome measures .\
RESULTS	No change in the psoriasis was noted during active or placebo treatment .\
RESULTS	Adverse clinical effects were reported more often during treatment with colchicine ( 14 patients ) than with the placebo ( four patients ) , resulting in the early withdrawal of three patients receiving colchicine from the trial .\
RESULTS	Increased creatine kinase values , without weakness , occurred during treatment with colchicine ( five patients ) and placebo ( four patients ) .\
CONCLUSIONS	In conclusion , our study did not provide evidence that colchicine is of therapeutic value in the treatment of psoriatic arthritis .\
\
###10022643\
OBJECTIVE	During recent years considerable interest has been focused on quality of life as an additional therapeutic outcome measure in the surgical treatment of gastric carcinoma .\
OBJECTIVE	However , the long term consequences of gastrectomy and the impact on quality of life of different reconstructive techniques are still a matter of controversy .\
OBJECTIVE	To broaden the criteria for choice of treatment , we conducted a prospective randomized clinical trial to determine the impact of various gastrectomy procedures on quality of life during a 5-yr follow-up period .\
METHODS	Consecutive patients ( n = 64 ) eligible for curative gastric cancer surgery were randomized to have either total ( n = 31 ) or subtotal ( n = 13 ) gastrectomy or a jejunal S-shaped pouch ( n = 20 ) as a gastric substitute after total gastrectomy .\
METHODS	Assessments of quality of life were made on seven occasions during a 5-yr period : within 1 wk before surgery , 3 and 12 months after the surgical intervention , and then once/yr .\
METHODS	All patients were interviewed by one of two psychiatrists , who rated their symptoms and introduced standardized self-report questionnaires covering both general and specific aspects of life .\
METHODS	The raters were blinded for the patients ' group affiliations .\
RESULTS	Survival rates were similar in all treatment groups .\
RESULTS	Patients who had a total gastrectomy continued to suffer from alimentary symptoms , especially indigestion and diarrhea , during the entire follow-up period .\
RESULTS	However , patients who underwent subtotal gastrectomy had a significantly better outcome already during the first postoperative yr .\
RESULTS	Patients given a gastric substitute after gastrectomy improved with the passage of time and had an even better outcome in the long run .\
CONCLUSIONS	To optimize the rehabilitation after gastrectomy , patients ' quality of life must be taken into consideration .\
CONCLUSIONS	When subtotal gastrectomy is clinically feasible , this procedure has advantages in the early postoperative period .\
CONCLUSIONS	However , a pouch reconstruction after total gastrectomy should be considered in patients having a favorable tumor status suggesting a fair chance of long term survival .\
\
###22732367\
OBJECTIVE	To compare clinical outcomes of tibial fixation between a biodegradable interference screw only and a biodegradable interference screw supplemented by a post-tie using a washer screw in single-bundle anterior cruciate ligament ( ACL ) reconstruction with 2-strand free tendon Achilles allograft in active young men .\
METHODS	A prospective study was performed in 80 subjects who underwent single-bundle ACL reconstruction .\
METHODS	A 2-strand free tendon Achilles allograft fixed with an EndoButton ( Smith & Nephew , Andover , MA ) in the femoral tunnel and with a Bio-Interference screw ( Arthrex , Naples , FL ) in the tibial tunnel was used in group I. Supplementary fixation was performed with a post-tie using a washer screw in group II .\
METHODS	The Lachman test , pivot-shift test , International Knee Documentation Committee classification , Lysholm score , range of knee motion , and side-to-side difference were evaluated preoperatively and at the last follow-up .\
METHODS	The Tegner activity scale was evaluated before injury and at the last follow-up .\
METHODS	The 1-leg hop test was assessed at the last follow-up .\
RESULTS	Of the patients , 36 in group I and 35 in group II could be followed up for at least 2 years .\
RESULTS	At the last follow-up , 7 patients in group I and 1 in group II showed a 2 + or 3 + on the Lachman test ( P = .027 ) .\
RESULTS	The mean side-to-side difference was 2.9 2.3 mm in group I and 1.4 1.6 mm in group II at the last follow-up ( P = .002 ) .\
RESULTS	The other clinical outcomes were not significantly different between the 2 groups .\
CONCLUSIONS	Supplementary tibial fixation with a post-tie in ACL reconstruction using 2-strand free tendon Achilles allograft was more effective than a biodegradable interference screw only in restoration of the anterior stability of the tibia .\
METHODS	Level II , randomized controlled trial .\
\
###11213851\
OBJECTIVE	To determine the relative bioavailability of lamotrigine ( LTG ) chewable dispersible tablets after rectal administration .\
METHODS	Two-period , crossover study with a 2-week washout between dosing periods .\
METHODS	Clinical research center .\
METHODS	Twelve healthy adult volunteers .\
METHODS	One hundred milligrams of a LTG chewable dispersible tablet was administered by oral and rectal routes .\
RESULTS	Plasma samples were collected before and up to 120 hours after drug administration .\
RESULTS	The samples were analyzed for LTG by high-performance liquid chromatography , and the relative bioavailability was determined .\
RESULTS	Drug concentrations were lower after rectal than after oral administration .\
RESULTS	The relative bioavailability ( F = AUC ( rectal ) / AUC ( oral ) ) was 0.52 + / - 0.23 ( SD ) .\
CONCLUSIONS	Drug prepared from LTG chewable dispersible tablets is absorbed rectally , although not to the same extent as when given orally .\
CONCLUSIONS	Rectal administration of suspension of these tablets can be an acceptable route of administration .\
\
###16023511\
BACKGROUND	Data from a pilot study suggested that noetic therapies-healing practices that are not mediated by tangible elements-can reduce preprocedural distress and might affect outcomes in patients undergoing percutaneous coronary intervention .\
BACKGROUND	We undertook a multicentre , prospective trial of two such practices : intercessory prayer and music , imagery , and touch ( MIT ) therapy .\
METHODS	748 patients undergoing percutaneous coronary intervention or elective catheterisation in nine USA centres were assigned in a 2x2 factorial randomisation either off-site prayer by established congregations of various religions or no off-site prayer ( double-blinded ) and MIT therapy or none ( unmasked ) .\
METHODS	The primary endpoint was combined in-hospital major adverse cardiovascular events and 6-month readmission or death .\
METHODS	Prespecified secondary endpoints were 6-month major adverse cardiovascular events , 6 month death or readmission , and 6-month mortality .\
RESULTS	371 patients were assigned prayer and 377 no prayer ; 374 were assigned MIT therapy and 374 no MIT therapy .\
RESULTS	The factorial distribution was : standard care only , 192 ; prayer only , 182 ; MIT therapy only , 185 ; and both prayer and MIT therapy , 189 .\
RESULTS	No significant difference was found for the primary composite endpoint in any treatment comparison .\
RESULTS	Mortality at 6 months was lower with MIT therapy than with no MIT therapy ( hazard ratio 0.35 ( 95 % CI 0.15-0 .82 , p = 0.016 ) .\
CONCLUSIONS	Neither masked prayer nor MIT therapy significantly improved clinical outcome after elective catheterisation or percutaneous coronary intervention .\
\
###9521968\
OBJECTIVE	To evaluate the clinical effectiveness of neonatal extracorporeal membrane oxygenation ( ECMO ) , in terms of mortality and morbidity , in the treatment of cardiorespiratory failure in term infants .\
METHODS	The criteria for trial entry were : an oxygenation index of > 40 or arterial partial pressure of carbon dioxide ( PaCO2 ) > 12 kPa for at least 3 hours ; gestational age at birth of 35 completed weeks or more ; a birth weight of 2 kg or more ; < 10 days high-pressure ventilation ; an age of < 28 days ; and no contraindication to ECMO such as previous cardiac arrest or intraventricular hemorrhage .\
METHODS	Eligible infants were randomized either to be transferred to one of five ECMO centers in the United Kingdom or to continue conventional treatment .\
METHODS	The principal outcome was death or severe disability at the age of 1 year .\
METHODS	Severe disability was defined as an overall developmental quotient of < 50 using the Griffiths Mental Development Scales , or blindness or a level of function so as to make assessment using the Griffiths Scales impossible .\
METHODS	Families of surviving children were contacted at regular intervals during the first year and at the age of 1 , and an assessment of the child was performed by one of three developmental pediatricians .\
METHODS	This included a neurologic examination , assessment of hearing and vision , developmental level , general health , and health service use .\
RESULTS	Of 185 infants recruited into the trial , 93 infants were in the ECMO arm and 92 were allocated conventional treatment .\
RESULTS	The groups were comparable at trial entry .\
RESULTS	Thirty of 93 ( 32 % ) ECMO infants died before the age of 1 year and 54 of 92 ( 59 % ) of the infants in the conventional group died .\
RESULTS	Two infants were lost to follow-up , 1 from each arm of the trial .\
RESULTS	Of the remaining 99 survivors , at the age of 1 year , 2 infants ( 1 in each arm ) were still in the hospital , and 5 ( 3 in the ECMO arm and 2 conventional ) still required supplementary oxygen .\
RESULTS	Fifteen infants had tone changes in the limbs , 10/62 ( 16 % ) in the ECMO arm and 5/37 ( 13.5 % ) in the conventional arm .\
RESULTS	These signs were more common on the left side in both groups .\
RESULTS	One infant ( in the ECMO arm ) had bilateral sensorineural deafness and 1 infant ( also in the ECMO arm ) had low vision .\
RESULTS	Overall , 2 infants were severely disabled ( 1 ECMO and 1 conventional ) , 16 others also had evidence of functional loss ( 12 vs 4 ) , and 8 had impairment without functional loss ( 4 vs 5 ) .\
RESULTS	There was a trend toward proportionately greater respiratory morbidity in the conventional group .\
RESULTS	Neurologic morbidity was more common in the ECMO group , reflecting the larger number of survivors .\
RESULTS	The lower rate of adverse primary outcome ( death or severe disability at 1 year ) was found among infants allocated ECMO in all the predefined stratified analyses .\
RESULTS	Disease severity at trial entry and type of referral center did not appear to alter the effects of ECMO .\
RESULTS	Only 4 of 18 infants with congenital diaphragmatic hernia survived and at age 1 year only 1 of the 4 survivors was considered normal .\
CONCLUSIONS	These results are in accord with the earlier preliminary findings that a policy of ECMO support reduces the risk of death without a concomitant rise in severe disability .\
CONCLUSIONS	However , 1 in 4 survivors had evidence of impairment with or without disability .\
CONCLUSIONS	Further follow-up is planned at the age of 4 and 7 years .\
\
###17105759\
BACKGROUND	It is unclear whether stable , high-risk patients with persistent total occlusion of the infarct-related coronary artery identified after the currently accepted period for myocardial salvage has passed should undergo percutaneous coronary intervention ( PCI ) in addition to receiving optimal medical therapy to reduce the risk of subsequent events .\
METHODS	We conducted a randomized study involving 2166 stable patients who had total occlusion of the infarct-related artery 3 to 28 days after myocardial infarction and who met a high-risk criterion ( an ejection fraction of < 50 % or proximal occlusion ) .\
METHODS	Of these patients , 1082 were assigned to routine PCI and stenting with optimal medical therapy , and 1084 were assigned to optimal medical therapy alone .\
METHODS	The primary end point was a composite of death , myocardial reinfarction , or New York Heart Association ( NYHA ) class IV heart failure .\
RESULTS	The 4-year cumulative primary event rate was 17.2 % in the PCI group and 15.6 % in the medical therapy group ( hazard ratio for death , reinfarction , or heart failure in the PCI group as compared with the medical therapy group , 1.16 ; 95 % confidence interval [ CI ] , 0.92 to 1.45 ; P = 0.20 ) .\
RESULTS	Rates of myocardial reinfarction ( fatal and nonfatal ) were 7.0 % and 5.3 % in the two groups , respectively ( hazard ratio , 1.36 ; 95 % CI , 0.92 to 2.00 ; P = 0.13 ) .\
RESULTS	Rates of nonfatal reinfarction were 6.9 % and 5.0 % , respectively ( hazard ratio , 1.44 ; 95 % CI , 0.96 to 2.16 ; P = 0.08 ) ; only six reinfarctions ( 0.6 % ) were related to assigned PCI procedures .\
RESULTS	Rates of NYHA class IV heart failure ( 4.4 % vs. 4.5 % ) and death ( 9.1 % vs. 9.4 % ) were similar .\
RESULTS	There was no interaction between treatment effect and any subgroup variable ( age , sex , race or ethnic group , infarct-related artery , ejection fraction , diabetes , Killip class , and the time from myocardial infarction to randomization ) .\
CONCLUSIONS	PCI did not reduce the occurrence of death , reinfarction , or heart failure , and there was a trend toward excess reinfarction during 4 years of follow-up in stable patients with occlusion of the infarct-related artery 3 to 28 days after myocardial infarction .\
CONCLUSIONS	( ClinicalTrials.gov number , NCT00004562 [ ClinicalTrials.gov ] . )\
\
###11561110\
OBJECTIVE	To compare ultrasonography with bone scintigraphy in the diagnosis of plantar fasciitis and to compare ultrasound-guided injection with palpation-guided injection in the management of idiopathic plantar fasciitis .\
METHODS	Twenty-three patients with a clinical diagnosis of idiopathic plantar fasciitis in 28 heels underwent ultrasonography and bone scintigraphy of both heels at baseline .\
METHODS	The patients were randomized to ultrasound - or palpation-guided injection of triamcinolone hexacetonide and xylocaine into the plantar fascia .\
METHODS	The 100 mm visual analogue scale ( VAS ) of pain , the heel tenderness index ( HTI ) , and ultrasonography were performed at baseline and follow-up ( mean = 13.4 weeks ) .\
RESULTS	The mean thickness ( + / - standard error of the mean ) of the plantar fascia , measured by ultrasonography , was 5.7 + / -0.3 mm in symptomatic heels as compared with 3.8 + / -0.2 mm in asymptomatic heels ( P < 0.001 ) .\
RESULTS	Ultrasonography findings correlated with bone scintigraphic findings in the diagnosis of plantar fasciitis ( P < 0.001 ) .\
RESULTS	Fourteen heels were randomized to ultrasound-guided injection , 10 heels were randomized to palpation-guided injection and four heels were not injected .\
RESULTS	Ultrasound - and palpation-guided injection resulted in significant mean improvements in VAS [ 39.6 + / -9.2 ( ultrasound ) vs 41.5 + / -8 ( palpation ) ] and HTI [ 1.35 + / -0.2 ( ultrasound ) vs 1.3 + / -0.4 ( palpation ) ] .\
RESULTS	There was no significant difference in the response rate following corticosteroid injection by either modality ( ultrasound = 13/14 , palpation = 8/10 ) .\
RESULTS	Following injection , the mean thickness of the plantar fascia decreased from 5.7 + / -0.3 mm to 4.65 + / -0.4 mm ( P < 0.01 ) .\
CONCLUSIONS	Ultrasonography and bone scintigraphy are equally effective in the diagnosis of plantar fasciitis .\
CONCLUSIONS	Ultrasound-guided injection is effective in the management of plantar fasciitis but is not more effective than palpation-guided injection .\
CONCLUSIONS	Ultrasonography may be used as an objective measure of response to treatment in plantar fasciitis .\
\
###17227394\
OBJECTIVE	Computer-aided learning ( CAL ) is a viable alternative to traditional teaching methods .\
OBJECTIVE	While CAL is used for teaching only , computer-aided testing ( CAT ) can be applied as a computer-based examination method .\
OBJECTIVE	The aim of the present study was to compare the performance of undergraduate students in computer-interactive tests and traditional multiple choice tests and to evaluate the influence of question length and language skills on test results .\
METHODS	Fifty-two native German-speaking students and five non-native speaking students were randomly assigned to two groups .\
METHODS	They were required to answer 20 conventional multiple choice questions and 20 questions using the interactive MobiTed system .\
METHODS	An analysis of variance and t-tests ( alpha = 0.05 ) were used to compare scores .\
RESULTS	Non-native speakers scored significantly lower on the interactive test compared with the native speaking students ( P = 0.048 for long questions and P = 0.003 for short questions ) .\
RESULTS	There were no significant group differences on the conventional multiple choice test ( P = 0.052 for long questions and P = 0.089 for short questions ) .\
RESULTS	Based on the results of the native speaking students neither test method nor question length had an influence on overall performance .\
CONCLUSIONS	Interactive multiple choice tests may provide an alternative to written tests , especially when considering time expenditure .\
CONCLUSIONS	Language skills and question length should be taken into account when setting time limits for examination .\
\
###24968148\
BACKGROUND	Aspiration pneumonia is a leading cause of death in people with Parkinson disease ( PD ) .\
BACKGROUND	The pathogenesis of these infections is largely attributed to the presence of dysphagia with silent aspiration or aspiration without an appropriate cough response .\
BACKGROUND	The goal of this study was to test reflex cough thresholds and associated urge-to-cough ( UTC ) ratings in participants with PD with and without dysphagia .\
METHODS	Twenty participants with PD were recruited for this study .\
METHODS	They completed a capsaicin challenge with three randomized blocks of 0 , 50 , 100 , and 200 M capsaicin and rated their UTC by modified Borg scale .\
METHODS	The concentration of capsaicin that elicited a two-cough response , total number of coughs , and sensitivity of the participant to the cough stimulus ( UTC ) were measured .\
METHODS	The dysphagia severity of participants with PD was identified with the penetration-aspiration scale .\
RESULTS	Most participants with PD did not have a consistent two-cough response to 200 M capsaicin .\
RESULTS	UTC ratings and total number of coughs produced at 200 M capsaicin were significantly influenced by dysphagia severity but not by general PD severity , age , or disease duration .\
RESULTS	Increasing levels of dysphagia severity resulted in significantly blunted cough sensitivity ( UTC ) .\
CONCLUSIONS	UTC ratings may be important in understanding the mechanism underlying morbidity related to aspiration pneumonia in people with PD and dysphagia .\
CONCLUSIONS	Further understanding of decreased UTC in people with PD and dysphagia will be essential for the development of strategies and treatments to address airway protection deficits in this population .\
\
###24641585\
BACKGROUND	Increased body mass index and weight gain are risk factors for psoriasis , and the prevalence of obesity in patients with psoriasis is higher than in the general population .\
BACKGROUND	Limited data exist regarding the role of diet in psoriasis .\
OBJECTIVE	To assess the impact of a dietary intervention combined with physical exercise for weight loss on improving psoriasis in overweight or obese patients .\
METHODS	This study included 303 overweight or obese patients with moderate-to-severe chronic plaque psoriasis who did not achieve clearance after 4 weeks of continuous systemic treatment .\
METHODS	They were randomized to receive either a 20-week quantitative and qualitative dietary plan associated with physical exercise for weight loss or simple informative counselling at baseline about the utility of weight loss for clinical control of psoriatic disease .\
METHODS	The main outcome was any reduction of the Psoriasis Area and Severity Index ( PASI ) from baseline to week 20 .\
RESULTS	Intention-to-treat analysis showed a median PASI reduction of 48 % ( 95 % confidence interval 33.3-58 .3 % ) in the dietary intervention arm and 25.5 % ( 95 % confidence interval 18.2-33 .3 % ) in the information-only arm ( P = 0.02 ) .\
RESULTS	Among secondary outcomes , PASI score reduction of 50 % significantly differed between study arms ( 49.7 % with dietary intervention vs. 34.2 % with information only , P = 0.006 ) .\
RESULTS	The weight-loss target ( a 5 % reduction from baseline ) was reached by 29.8 % of patients in the dietary intervention arm compared with 14.5 % in the information-only arm ( P = 0.001 ) .\
CONCLUSIONS	A 20-week dietetic intervention associated with increased physical exercise reduced psoriasis severity in systemically treated overweight or obese patients with active psoriasis .\
\
###10877376\
OBJECTIVE	The aim of this study is to describe and compare test-retest variability of threshold-related suprathreshold and threshold examination strategies .\
METHODS	Threshold-related suprathreshold and FASTPAC threshold central visual field examinations were performed twice ( test and retest ) within a 4-week period on 322 subjects with early to moderate primary open-angle glaucoma and glaucoma suspects .\
METHODS	For both strategies , defects were quantified by a count , or score , of the number of defective locations within the field as a whole and by hemifield , thereby providing a simple measure of defect extent .\
METHODS	This quantification was obtained for the suprathreshold strategy at three suprathreshold increments ( 5 , 8 , and 12 dB ) and for the full threshold strategy at two levels of pattern deviation probability , although absolute full threshold defect depth was not considered .\
METHODS	Mean test-retest score differences and spread of score differences were used to describe variability .\
METHODS	An index of relative variability was used to compare the two visual field examination strategies .\
RESULTS	Marked degrees of defect extent variability were found to exist in both suprathreshold and FASTPAC examination strategies .\
RESULTS	In general , the suprathreshold strategy exhibited lower test-retest variability of defect extent than the FASTPAC strategy .\
RESULTS	Suprathreshold test variability was dependent on the suprathreshold increment .\
RESULTS	FASTPAC examination variability was independent of defect depth when analyzed on the basis of pattern deviation probability values and was also found to be independent of the area of visual field loss .\
CONCLUSIONS	Suprathreshold examination techniques may provide a reliable perimetric alternative to thresholding strategies for monitoring individuals with early and moderate glaucoma , although they may not be suitable for individuals with advanced glaucomatous visual field loss .\
\
###17986904\
OBJECTIVE	To investigate the effect of ingesting a carbohydrate-electrolyte solution ( CHO-E ) , in subjects with reduced carbohydrate stores , during an intermittent shuttle running test ( LIST ) on soccer passing ( LSPT ) and shooting ( LSST ) performance .\
METHODS	Sixteen healthy male university soccer players ingested either a 6.4 % CHO-E or placebo ( PLA ) solution during 90 min of the LIST ( 5 mL x kg ( -1 ) BM before and 2 mL x kg ( -1 ) BM every 15 min of exercise ) , in a double-blind , randomized , crossover design , with each trial separated by at least 7 d. On the evening before the main trial ( 17:00 h ) , subjects performed the glycogen-reducing cycling exercise ( approximately 80 min at 70 % VO2max ) .\
METHODS	They were then fed a low-carbohydrate evening meal and reported to the laboratory the following morning after a 10-h fast .\
METHODS	Blood was collected at rest and after every 30 min of exercise ; skill tests were performed before and after the LIST .\
RESULTS	The change in mean LSST performance from pre - to post-LIST was better in the CHO-E trial ( 11 + / - 45 vs -16 + / - 42 % ; P < 0.01 ) but not significantly different for the LSPT performance ( -1 + / - 10 % ( CHO-E ) vs -6 + / - 13 % ( PLA ) , P = 0.13 ) .\
RESULTS	Sprint performance during the LIST was quicker in the CHO-E trial ( 2.50 + / - 0.13 vs 2.53 + / - 0.13 s , P < 0.01 ) .\
RESULTS	Plasma glucose was higher in the CHO-E trial after 90 min of exercise ( 5.2 + / - 0.3 vs 3.9 + / - 0.4 mM , P < 0.01 ) .\
CONCLUSIONS	Ingestion of a carbohydrate-electrolyte solution during exercise enabled subjects with compromised glycogen stores to better maintain skill and sprint performance than when ingesting fluid alone .\
\
###19323613\
OBJECTIVE	To evaluate efficacy and tolerability of once-daily cyclobenzaprine extended release ( CER ) 15 - and 30-mg capsules in patients with muscle spasm associated with acute , painful musculoskeletal conditions .\
METHODS	Two identically designed , randomized , double-blind , placebo - and active-controlled , parallel-group studies in patients aged 18-75 years with muscle spasm associated with neck or back pain .\
METHODS	Patients received CER 15 or 30 mg once daily , cyclobenzaprine immediate release ( CIR ) 10 mg three times daily , or placebo for 14 days .\
METHODS	Primary efficacy measures were patient 's rating of medication helpfulness and physician 's clinical global assessment of response to therapy at day 4 .\
METHODS	Secondary measures were patient 's rating of medication helpfulness and physician 's clinical global assessment of response ( days 8 and 14 ) , relief from local pain , global impression of change , restriction in activities of daily living , restriction of movement , daytime drowsiness , quality of nighttime sleep ( days 4 , 8 , and 14 ) , and quality of life ( days 8 and 14 ) .\
RESULTS	A total of 156/254 randomized patients in study 1 and 174/250 in study 2 completed 14 days of treatment .\
RESULTS	Significant improvements in patient 's rating of medication helpfulness were reported with CER versus placebo ( CER 30 mg , study 1 , p = 0.007 ; CER 15 mg , study 2 , p = 0.018 ) at day 4 .\
RESULTS	Significant improvements with CER 30 mg versus placebo were also seen at day 4 in study 1 for patient-rated global impression of change ( p = 0.008 ) , relief of local pain ( p = 0.004 ) , and restriction of movement ( p = 0.002 ) .\
RESULTS	Neither study reported differences between study groups on the physician 's clinical global assessment .\
RESULTS	Improvements with CER were comparable to that of CIR .\
RESULTS	In both studies , daytime drowsiness was reported more frequently in active treatment groups than in the placebo group ; however , reports of drowsiness decreased over time in all groups .\
RESULTS	In general , daytime drowsiness was reported more frequently in CIR groups than in CER groups .\
RESULTS	More adverse events were reported in the active treatment groups versus placebo and were similar in the CER and CIR groups , except somnolence , which occurred more frequently with CIR .\
CONCLUSIONS	Once-daily CER 15 mg ( study 2 ) and CER 30 mg ( study 1 ) were effective in treating muscle spasm associated with painful musculoskeletal conditions after 4 days of treatment .\
CONCLUSIONS	Differences between CER and placebo groups did not reach statistical significance on all efficacy measures , and the protocols were not powered to detect differences between active treatment arms .\
CONCLUSIONS	CER was generally safe and well tolerated , with low rates of somnolence .\
\
###17785708\
OBJECTIVE	Breast cancer chemotherapy may cause unfavorable changes in physical functioning , body composition , psychosocial functioning , and quality of life ( QOL ) .\
OBJECTIVE	We evaluated the relative merits of aerobic and resistance exercise in blunting these effects .\
METHODS	We conducted a multicenter randomized controlled trial in Canada between 2003 and 2005 that randomly assigned 242 breast cancer patients initiating adjuvant chemotherapy to usual care ( n = 82 ) , supervised resistance exercise ( n = 82 ) , or supervised aerobic exercise ( n = 78 ) for the duration of their chemotherapy ( median , 17 weeks ; 95 % CI , 9 to 24 weeks ) .\
METHODS	Our primary end point was cancer-specific QOL assessed by the Functional Assessment of Cancer Therapy-Anemia scale .\
METHODS	Secondary end points were fatigue , psychosocial functioning , physical fitness , body composition , chemotherapy completion rate , and lymphedema .\
RESULTS	The follow-up assessment rate for our primary end point was 92.1 % , and adherence to the supervised exercise was 70.2 % .\
RESULTS	Unadjusted and adjusted mixed-model analyses indicated that aerobic exercise was superior to usual care for improving self-esteem ( P = .015 ) , aerobic fitness ( P = .006 ) , and percent body fat ( adjusted P = .076 ) .\
RESULTS	Resistance exercise was superior to usual care for improving self-esteem ( P = .018 ) , muscular strength ( P < .001 ) , lean body mass ( P = .015 ) , and chemotherapy completion rate ( P = .033 ) .\
RESULTS	Changes in cancer-specific QOL , fatigue , depression , and anxiety favored the exercise groups but did not reach statistical significance .\
RESULTS	Exercise did not cause lymphedema or adverse events .\
CONCLUSIONS	Neither aerobic nor resistance exercise significantly improved cancer-specific QOL in breast cancer patients receiving chemotherapy , but they did improve self-esteem , physical fitness , body composition , and chemotherapy completion rate without causing lymphedema or significant adverse events .\
\
###16311083\
OBJECTIVE	To investigate the effects of combined administration of octreotide and methylglucamine diatrizoate in the older persons with adhesive small bowel obstruction .\
METHODS	One hundred and sixty-two consecutive patients who had suffered from adhesive intestinal obstruction without clinical evidence of strangulation or gangrene were randomised into two groups , a control group ( treated conservatively , n = 82 ) and a contrast group ( treated with combined administration of octreotide and methylglucamine diatrizoate , n = 80 ) .\
METHODS	A laparotomy was performed in both the two groups if symptoms of strangulation developed or the obstruction did not resolve spontaneously after 72 h.\
RESULTS	Statistically significant rapid reduction in pain score , lower amount of nasogastric drainage , shorter hospital stay , lower operative rate and lower postoperative morbidity were observed in the contrast group .\
RESULTS	Among the non-operative patients , earlier passage of stool and gas , earlier first oral intake and shorter duration of nasogastric tube placement were significantly more frequently observed in the contrast group .\
RESULTS	No difference in the rate of readmission was found between the two groups .\
CONCLUSIONS	Combined administration of octreotide and methylglucamine diatrizoate accelerates resolution of small bowel obstruction by a specific therapeutic effect and is safe for the older persons .\
\
###20457363\
OBJECTIVE	To compare visual acuity at different distances after bilateral implantation of 1 of 4 multifocal intraocular lenses ( IOLs ) .\
METHODS	Fernndez-Vega Ophthalmological Institute , Oviedo , Spain .\
METHODS	This study evaluated consecutive patients who had bilateral implantation of a spherical multifocal IOL with a +4.00 diopter ( D ) addition ( add ) ( AcrySof ReSTOR SN60D3 ) or an aspheric multifocal IOL with a +4.00 D add ( AcrySof ReSTOR SN6AD3 ) , +3.75 D add ( Acri.LISA 366D ) , or +3.00 D add ( AcrySof ReSTOR SN6AD1 ) .\
METHODS	Six months postoperatively , binocular measurement of corrected distance visual acuity ( CDVA ) at 4 m , corrected near visual acuity ( CNVA ) at 40 cm , and corrected intermediate visual acuity ( CIVA ) at 50 , 60 , 70 , and 80 cm were performed ; the defocus curve was also measured .\
RESULTS	Each IOL model was implanted in 20 eyes ( 10 patients ) .\
RESULTS	All IOL models resulted in good distance vision , with no statistically significant differences between models .\
RESULTS	Patients with the +3.00 aspheric IOL had statistically better binocular CIVA at 50 , 60 , and 70 cm ( P < .0001 ) and binocular CNVA at 40 cm ( P = 3 x 10 ( -3 ) ) than patients with the other IOL models .\
CONCLUSIONS	Patients with bilateral multifocal aspheric IOLs with a lower add had better intermediate and distance near visual acuity than patients with bilateral multifocal spherical IOLs or bilateral aspheric IOLs with a higher add .\
\
###20573384\
OBJECTIVE	To compare the outcome of intrafascial nerve-sparing endoscopic extraperitoneal radical prostatectomy ( nsEERPE ) with interfascial ( standard ) nsEERPE .\
METHODS	Four-hundred patients underwent nsEERPE ; 200 patients underwent bilateral intrafascial nsEERPE ( group A ) and 200 bilateral standard nsEERPE ( group B ) .\
METHODS	Tumor stages of T1 and T2a , prostate-specific antigen level < 10 ng/mL , maximal Gleason score 3 +4 ( not 4 +3 ) and preoperative potency were considered as candidates for nsEERPE .\
METHODS	Patients were randomized to the aforementioned groups .\
METHODS	Perioperative data , and functional and oncological outcome were reviewed .\
METHODS	Patients not requiring any pads or requiring 1 pad for safety were defined as continent .\
METHODS	Patients responding positively to sexual encounter profile diary question numbers 2 , 3 , and 5 were considered as potent .\
RESULTS	Perioperative data were similar between groups .\
RESULTS	At 3 months , 74 % of group A and and 63 % of group B were continent .\
RESULTS	At 6 months , the respective figures were 87.9 % and 76.2 % , respectively ( A , B ) .\
RESULTS	At 12 months , 93.2 % of group A and 90.7 % of group B were continent .\
RESULTS	Potency rates of group A were 93.5 % ( < 55 years ) , 83.3 % ( 55-65 years ) , and 60 % ( > 65 years ) at 12 months .\
RESULTS	The respective figures for Group B were 77.1 % , 50 % , and 40 % .\
RESULTS	Positive surgical margins were detected in 9 % and 9.5 % of groups A and B , respectively .\
CONCLUSIONS	Intrafascial nsEERPE provides significantly better potency in patients < 55 years of age at 12 months and in patients 55-65 years of age at 6 and 12 months , with probably limited effect on the oncological outcome .\
CONCLUSIONS	Significantly improved continence was observed at 3 and 6 months in favor of intrafascial nsEEPRE .\
\
###22136031\
OBJECTIVE	To observe the protective effect of acupuncture-drug compound anesthesia with different frequency electroacupuncture on stress reaction in pneumonectomy and to explore potential mechanisms .\
METHODS	Eighty patients scheduled for pneumonectomy were randomly divided into four groups , named group A , B , C and D , 20 cases in each group .\
METHODS	General anesthesia and single lung protective mechanical ventilation were produced in all the groups .\
METHODS	They were treated with acupuncture at Houxi ( SI 3 ) , Zhigou ( TE 6 ) , Neiguan ( PC 6 ) , and Hegu ( Li 4 ) 30 min before general anesthesia , and then with Han 's acupoint nerve stimulator ( HANS-200 ) .\
METHODS	The acupuncture needles without needle bodies were pasted on the acupoints and the electroacupuncture were not turned on in group A , and the 2 Hz continuous wave were produced in group B , and 100 Hz continuous wave were produced in group C and the 2 Hz/100 Hz were produced in group D.\
METHODS	The supplementary anesthesia medicine during pneumonectomy , heart rate ( HR ) , mean arterial pressure ( MAP ) , CD4 + / CD / in venous blood before and after the surgery , and the contents of epinephrine ( E ) and cortisol ( Cor ) in plasma at the time of inter-room and outer-room were detected .\
RESULTS	( 1 ) The supplementary fentanyl in group B and C were lower than those in group A and D ( P < 0.05 , P < 0.01 ) .\
RESULTS	( 2 ) The MAP in the four groups at intratracheal intubation ( T1 ) were all higher than those at before anesthesia ( T0 ) ( all P < 0.01 ) , and the ascending extent in group B , C and D were lower than that in group A ( all P < 0.01 ) .\
RESULTS	The HR at T in group A was higher than that at T0 ( P < 0.05 ) and there were no significant differences in the other groups ( all P > 0.05 ) , and the ascending extent in group B and D were lower than that in group A ( both P < 0.05 ) .\
RESULTS	The MAP and HR at the other moment in all the groups were maintained stable .\
RESULTS	( 3 ) CD4 + / CD8 + in group A after pneumonectomy was lower than that before the surgery ( P < 0.05 ) , and there were no significant differences in the other groups ( all P > 0.05 ) .\
RESULTS	( 4 ) The content of E and Cor after the surgery were all increased ( all P < 0.01 ) , and the ascending extent of E in group D was lower than that in group A ( P < 0.05 ) , and the ascending level of Cor in group B and D were lower than that in group A ( P < 0.01 ) and group B compared with group C and D were got the same result .\
CONCLUSIONS	Acupuncture-drug compound anesthesia can attenuate the stress reaction so as to protect organs under the condition of less drug and can alleviates the undulate phenomenon of MAP and HR at intubation and stabilize CD4 + / CD8 + after pneumonectomy .\
CONCLUSIONS	Among them , the 2 Hz and 2 Hz/100 Hz electroacupuncture groups have the comparatively better effects .\
\
###24561972\
BACKGROUND	urgent development of effective interventions to prevent rapidly rising childhood obesity in China is needed .\
METHODS	Between May 2010 and December 2013 , a cluster randomized controlled trial was conducted among 4th graders in eight urban primary schools randomly assigned to intervention or control groups in Nanjing , China .\
METHODS	A multi-component intervention program was implemented within the treatment group , while students in the control group followed their usual health education curriculum without additional intervention .\
RESULTS	At baseline , 638 and 544 students were enrolled in the intervention and control group , respectively .\
RESULTS	The prevalence of excess body weight was 26.8 % , with 27.4 % in the intervention group and 26.1 % in the control group ( p = 0.61 ) .\
RESULTS	The mean ( SD ) BMI and WC was 18.7 ( 3.0 ) and 63.0 ( 9.2 ) for participants in intervention schools , and 18.5 ( 2.9 ) and 63.6 ( 8.7 ) for students in control group , separately ( p = 0.24 and 0.41 , respectively ) .\
RESULTS	Compared to those who were not aware of what lifestyle/behavior factors were unhealthy , students who were aware of the unhealthy lifestyle / behavior factors consumed fewer fried snacks ( 0.460.76 serves/week vs 0.650.91 serves/week ; p < 0.01 ) , soft drinks ( 160194 ml/week vs 199227 ml/week ; p < 0.01 ) , but larger amount of meat ( 502429 g/week vs 449344 g/week ; p = 0.03 ) , and reported less screen time ( 214232 minutes/week vs 252264 minutes/week ; p < 0.01 ) .\
RESULTS	Moreover , there was no difference within physical activity time between these two groups ( 257341 minutes/week vs 218324 minutes/week ; p = 0.13 ) .\
CONCLUSIONS	Main characteristics of participants were balanced at baseline within intervention and control schools , but a gap existed between healthy lifestyle knowledge and actual healthy behavior in students .\
BACKGROUND	ChiCTR-ERC-11001819 .\
\
###24215485\
OBJECTIVE	The aim of the study was to investigate the effect of a simplified regimen , in terms of reducing pill burden , dietary requirements and possible adverse effects , on patients ' adherence , treatment satisfaction and quality of life ( QoL ) .\
METHODS	Antiretroviral-nave patients who achieved a viral load < 50 HIV-1 RNA copies/ml after induction therapy with twice-daily ( bid ) lopinavir/ritonavir ( LPV/r ) and fixed-dose zidovudine ( ZDV ) / lamivudine ( 3TC ) ( CBV ) were randomly assigned to continue CBV/LPV/r or switch to fixed-dose ZDV/3TC/abacavir ( TZV ) .\
METHODS	Patients completed standardized questionnaires on adherence , treatment satisfaction and QoL at randomization ( between weeks 12 and 24 ) and at weeks 48 , 72 and 96 .\
RESULTS	Patients on CBV/LPV/r were more likely to have skipped medicines in the last week ( P = 0.035 ) and during the preceding weekend ( P = 0.027 ) than patients on TZV .\
RESULTS	Patients on CBV/LPV/r were significantly less satisfied with the convenience of their treatment ( P = 0.004 ) and tended to be less satisfied with the side effects of their treatment ( P = 0.091 ) and continuation of their present treatment ( P = 0.056 ) than patients on TZV .\
RESULTS	Patients on CBV/LPV/r reported significantly lower levels of role functioning ( P = 0.013 ) than patients on TZV .\
CONCLUSIONS	In this randomized controlled trial , simplification of therapy to fixed-dose TZV among patients with suppressed HIV RNA was perceived to be more convenient , and resulted in improved adherence and better role functioning , than continuing treatment with CBV/LPV/r .\
\
###22232129\
BACKGROUND	Endometriosis is a chronic inflammatory disease of unknown aetiology that can cause severe dysmenorrhea .\
BACKGROUND	Lignocaine has anti-inflammatory properties and exerts effects on nerve endings and intra-peritoneal macrophages .\
BACKGROUND	The objective of this study was to evaluate the effect of pertubation with Ringer-Lignocaine on dysmenorrhea in women with endometriosis .\
METHODS	A double-blind randomized controlled trial ( RCT ) was carried out at three sites in Stockholm , Sweden .\
METHODS	Eligible patients had endometriosis as diagnosed by laparoscopy , dysmenorrhoic pain > VAS 50 mm ( visual analogue scale ) and patent Fallopian tubes .\
METHODS	The study patients were randomized sequentially to preovulatory pertubations with placebo ( n = 18 ) or study treatment ( n = 24 ) during three consecutive menstrual cycles .\
METHODS	The pertubation procedure comprised passing study solution through the uterine cavity and the Fallopian tubes via an intra-cervical balloon catheter .\
METHODS	The effect on pain was evaluated with VAS scales before and after the treatments and up to nine menstrual cycles after the last pertubation .\
METHODS	Success was defined as a reduction of 50 % on the VAS scale after the third pertubation .\
METHODS	The success rate between the treatment and the placebo group was compared with Fisher 's exact test .\
RESULTS	In the intention-to-treat analysis , the success rate was 41.7 % ( 10 of 24 ) in the treatment group compared with 16.7 % ( 3 of 18 ) in the placebo group ( P = 0.10 , 95 % CI -7.3 to 36.2 % ) .\
RESULTS	In the per protocol analysis , the success rate in the treatment group was 45 % ( 9 of 20 ) compared with 7.1 % ( 1 of 14 ) in the placebo group ( P = 0.024 , 95 % CI -2.6 to 44.8 % ) .\
RESULTS	Of the nine patients in the lignocaine group who fulfilled the criteria for success after three pertubations , 4 ( 44 % ) had an effect persisting after nine months .\
RESULTS	The treatments were well tolerated .\
CONCLUSIONS	This small RCT indicates that pertubation with lignocaine is a non-hormonal treatment option for patients with dysmenorrhea and endometriosis .\
CONCLUSIONS	ClinicalTrials.gov identifier : NCT01329796 .\
\
###22092784\
OBJECTIVE	The present randomized clinical trial compared the long-term results of subepithelial connective tissue graft ( SCTG ) versus acellular dermal matrix allograft ( ADMA ) in treatment of gingival recessions .\
METHODS	In 16 patients with bilateral Miller Class I/II gingival recessions , one side was treated with SCTG and the other side with ADMA .\
METHODS	Clinical parameters were measured at baseline , 6months , and at 5years post-surgery .\
RESULTS	Fifteen patients completed the study .\
RESULTS	At 6months , all parameters showed significant improvement in ADMA and SCTG groups [ complete root coverage ( CRC ) : 73.3 % versus 26.7 % , p = 0.027 ; reduction of recession depth ( RD ) : 2.61.1 mm versus 2.21.1 mm , p = 0.376 ; reduction of recession width ( RW ) : 3.01.4 mm versus 2.41.4 mm , p = 0.207 respectively ] .\
RESULTS	At 5years , significant relapses were detected in CRC and reduction of RD and RW in both groups with no statistically significant difference ( CRC : 20.0 % versus 13.3 % , p = 1.00 ; RD : 1.61.2 mm versus 1.51.4 mm , p = 0.838 ; RW : 1.81.4 mm versus 1.31.5 mm , p = 0.367 ) .\
RESULTS	Patients practicing horizontal toothbrushing habit showed more relapse ( OR = 11.2 ; p = 0.01 ) .\
RESULTS	Compared with baseline , the gingival width ( GW ) did not increase in ADMA-treated sites ( p = 0.903 ) .\
CONCLUSIONS	Five-year results of SCTG and ADMA were similar in terms of CRC and reduction of RD and RW .\
CONCLUSIONS	Both techniques showed a significant relapse associated with returning to horizontal toothbrushing habit .\
CONCLUSIONS	Increase of GW was stable in SCTG-treated sites , but reached to pre-surgical values in ADMA-treated cases .\
\
###15857102\
BACKGROUND	Conventional dentoalveolar osseous reconstruction often involves the use of grafting materials with or without barrier membranes .\
BACKGROUND	The purpose of this study was to evaluate the efficacy of bone induction for the placement of dental implants by two concentrations of recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) delivered on a bioabsorbable collagen sponge ( ACS ) compared to placebo ( ACS alone ) and no treatment in a human buccal wall defect model following tooth extraction .\
METHODS	Eighty patients requiring local alveolar ridge augmentation for buccal wall defects ( > or = 50 % buccal bone loss of the extraction socket ) of the maxillary teeth ( bicuspids forward ) immediately following tooth extraction were enrolled .\
METHODS	Two sequential cohorts of 40 patients each were randomized in a double-masked manner to receive 0.75 mg/ml or 1.50 mg/ml rhBMP-2 / ACS , placebo ( ACS alone ) , or no treatment in a 2:1:1 ratio .\
METHODS	Efficacy was assessed by evaluating the amount of bone induction , the adequacy of the alveolar bone volume to support an endosseous dental implant , and the need for a secondary augmentation .\
RESULTS	Assessment of the alveolar bone indicated that patients treated with 1.50 mg/ml rhBMP-2 / ACS had significantly greater bone augmentation compared to controls ( P < or = 0.05 ) .\
RESULTS	The adequacy of bone for the placement of a dental implant was approximately twice as great in the rhBMP-2 / ACS groups compared to no treatment or placebo .\
RESULTS	In addition , bone density and histology revealed no differences between newly induced and native bone .\
CONCLUSIONS	The data from this randomized , masked , placebo-controlled multicenter clinical study demonstrated that the novel combination of rhBMP-2 and a commonly utilized collagen sponge had a striking effect on de novo osseous formation for the placement of dental implants .\
\
###18718007\
BACKGROUND	Postpartum hemorrhage ( PPH ) remains a major killer of women worldwide .\
BACKGROUND	Standard uterotonic treatments used to control postpartum bleeding do not always work and are not always available .\
BACKGROUND	Misoprostol 's potential as a treatment option for PPH is increasingly known , but its use remains ad hoc and available evidence does not support the safety or efficacy of one particular regimen .\
BACKGROUND	This study aimed to determine the adjunct benefit of misoprostol when combined with standard oxytocics for PPH treatment .\
METHODS	A randomized controlled trial was conducted in four Karachi hospitals from December 2005 - April 2007 to assess the benefit of a 600 mcg dose of misoprostol given sublingually in addition to standard oxytocics for postpartum hemorrhage treatment .\
METHODS	Consenting women had their blood loss measured after normal vaginal delivery and were enrolled in the study after losing more than 500 ml of blood .\
METHODS	Women were randomly assigned to receive either 600 mcg sublingual misoprostol or matching placebo in addition to standard PPH treatment with injectable oxytocics .\
METHODS	Both women and providers were blinded to the treatment assignment .\
METHODS	Blood loss was collected until active bleeding stopped and for a minimum of one hour after PPH diagnosis .\
METHODS	Total blood loss , hemoglobin measures , and treatment outcomes were recorded for all participants .\
RESULTS	Due to a much lower rate of PPH than expected ( 1.2 % ) , only sixty-one patients were diagnosed and treated for their PPH in this study , and we were therefore unable to measure statistical significance in any of the primary endpoints .\
RESULTS	The addition of 600 mcg sublingual misoprostol to standard PPH treatments does , however , suggest a trend in reduced postpartum blood loss , a smaller drop in postpartum hemoglobin , and need for fewer additional interventions .\
RESULTS	Women who bled less overall had a significantly smaller drop in hemoglobin and received fewer additional interventions .\
RESULTS	There were no hysterectomies or maternal deaths among study participants .\
RESULTS	The rate of transient shivering and fever was significantly higher among women receiving misoprostol\
CONCLUSIONS	A 600 mcg dose of misoprostol given sublingually shows promise as an adjunct treatment for PPH and its use should continue to be explored for its life-saving potential in the care of women experiencing PPH .\
BACKGROUND	Clinical trials.gov , Registry No .\
BACKGROUND	NCT00116480 .\
\
###20650046\
OBJECTIVE	This study is aimed at conducting a program for two different anesthetic methods used during a spinal fusion surgery to ensure better intra-operative hemodynamic stability and post-operative pain control .\
METHODS	A prospective , randomized , double blind study in patients scheduled for spinal fusion surgery , who were randomly allocated to two groups , G1 and G2 , ( n = 15 per group ) , class I-II ASA , was carried out .\
METHODS	Both groups received pre-operatively midazolam , followed intra-operatively by propofol , sevoflurane , atracurium , and either remifentanil infusion 0.2 microg/kg/min ( G1 ) , or the same dose of remifentanil infusion and low doses of ketamine infusion 1 microg/kg/min ( G2 ) anesthetics , antidote medication and post-operative morphine doses .\
METHODS	HR , MAP , vital signs , surgical bleeding , urine output , duration of surgery and duration of anesthesia were recorded .\
METHODS	In a 24-h recovery period in a post-anesthesia care unit ( PACU ) the recovery time , the first pain score and analgesic requirements were measured .\
RESULTS	Intra-operative HR and arterial BP were significantly less ( p < 0.05 ) in G1 as compared to G2 .\
RESULTS	In the PACU the first pain scores were significantly less ( p < 0.05 ) in G2 than in G1 .\
RESULTS	The time for the first patient analgesia demand dose was greater in G2 , as also morphine consumption which was greater in G1 than G2 ( p < 0.05 ) .\
RESULTS	Other results were the same .\
RESULTS	None of the patients had any adverse drug reaction .\
CONCLUSIONS	Adding low doses of ketamine hydrochloride could be a routine therapy to improve the hemodynamic stability and reduce the post-operative morphine consumption during spinal fusion surgery .\
\
###23608721\
OBJECTIVE	The most safe and effective dose of vitamin D supplementation for healthy adolescents is currently unknown .\
OBJECTIVE	The aim of this study was to compare the efficacy of 200 IU versus 1,000 IU of daily vitamin D3 for supplementation in healthy adolescents with baseline vitamin D sufficiency .\
METHODS	We conducted a double-blind , randomized clinical trial .\
METHODS	Fifty-six subjects , ages 11-19 years , with baseline vitamin D sufficiency received 1,000 IU or 200 IU of daily vitamin D3 for 11 weeks .\
METHODS	Compliance was assessed using MEMS6 Trackcaps and pill counts .\
RESULTS	Fifty-three subjects completed the clinical trial .\
RESULTS	Subjects in the two treatment arms were similar in terms of age , race , gender , body mass index , and dietary calcium and vitamin D intake .\
RESULTS	Serum 25 ( OH ) D level in the 200 IU treatment arm was 28.1 6.2 ng/mL at baseline ( mean SD ) and 28.9 7.0 ng/mL at follow-up .\
RESULTS	In the 1,000 IU treatment arm , 25 ( OH ) D levels were 29.0 7.3 and 30.1 6.6 at baseline and follow-up , respectively .\
RESULTS	Mean change in 25 ( OH ) D level did not differ significantly between treatment arms ( p = .87 ) , nor did mean change in parathyroid hormone , calcium , phosphate , bone turnover markers , fasting glucose , or fasting insulin .\
CONCLUSIONS	In healthy adolescents with baseline vitamin D sufficiency , supplementation with vitamin D3 doses of 200 and 1,000 IU for 11 weeks did not increase serum 25 ( OH ) D levels , with no significant difference observed between treatment arms .\
\
###20431994\
BACKGROUND	Since implicit attitudes toward alcohol play an important role in drinking behavior , a possible way to obtain a behavioral change is changing these implicit attitudes .\
OBJECTIVE	This study examined whether a change in implicit attitudes and in drinking behavior can be achieved via evaluative conditioning .\
METHODS	Participants were randomly assigned to an experimental condition and a control condition .\
METHODS	In the experimental condition , participants were subjected to an evaluative conditioning procedure that consistently pairs alcohol-related cues with negative stimuli .\
METHODS	In the control condition , alcohol-related cues were consistently paired with neutral stimuli during the evaluative conditioning phase .\
METHODS	Implicit attitudes , explicit attitudes , and drinking behavior were measured before and after the evaluative conditioning phase .\
RESULTS	Following the evaluative conditioning procedure , participants in the experimental condition showed stronger negative implicit attitudes toward alcohol and consumed less alcohol compared to participants in the control condition .\
RESULTS	However , this effect was only found when the evaluative conditioning task paired alcohol-related cues with general negative pictures , but not when using pictures of frowning faces .\
CONCLUSIONS	These results demonstrate that evaluative conditioning can effectively change implicit attitudes toward alcohol and also suggest that this procedure can be used to change drinking behavior .\
CONCLUSIONS	Hence , evaluative conditioning may be a useful new intervention tool to combat alcohol misuse .\
\
###22124031\
OBJECTIVE	It is thought that following a stroke the contralesional motor region exerts an undue inhibitory influence on the lesional motor region which might limit recovery .\
OBJECTIVE	Pilot studies have shown that suppressing the contralesional motor region with cathodal transcranial Direct Current Stimulation ( tDCS ) can induce a short lasting functional benefit ; greater and longer lasting effects might be achieved with combining tDCS with simultaneous occupational therapy ( OT ) and applying this intervention for multiple sessions .\
METHODS	We carried out a randomized , double blind , sham controlled study of chronic stroke patients receiving either 5 consecutive days of cathodal tDCS ( for 30 minutes ) applied to the contralesional motor region and simultaneous OT , or sham tDCS + OT .\
RESULTS	we showed that cathodal tDCS + OT resulted in significantly more improvement in Range-Of-Motion in multiple joints of the paretic upper extremity and in the Upper-Extremity Fugl-Meyer scores than sham tDCS + OT , and that the effects lasted at least one week post-stimulation .\
RESULTS	Improvement in motor outcome scores was correlated with decrease in fMRI activation in the contralesional motor region exposed to cathodal stimulation .\
CONCLUSIONS	This suggests that cathodal tDCS combined with OT leads to significant motor improvement after stroke due to a decrease in the inhibitory effect that the contralesional hemisphere exerts onto the lesional hemisphere .\
\
###25118794\
OBJECTIVE	To evaluate the feasibility and preliminary efficacy of a Web-based tobacco treatment for persons living with HIV ( PLWH ) .\
METHODS	Prospective , randomized controlled trial .\
METHODS	HIV-care center in the Bronx , New York .\
METHODS	Eligibility criteria included HIV infection , current tobacco usage , interest in quitting , and access to a computer with internet .\
METHODS	One hundred thirty-eight subjects enrolled , and 134 completed the study .\
METHODS	Positively Smoke Free on the Web ( PSFW ) , an 8-session , 7-week targeted tobacco treatment program for PLWH , was compared with standard care ( brief advice to quit and self-help brochure ) .\
METHODS	All subjects were offered nicotine patches .\
METHODS	The main feasibility outcomes were number of sessions logged into , number of Web pages visited , number of interactive clicks , and total time logged in .\
METHODS	The main efficacy outcome was biochemically verified , 7-day point prevalence abstinence 3 months after intervention .\
RESULTS	PSFW subjects logged into a mean of 5.5 of 8 sessions and 26.2 of 41 pages .\
RESULTS	They executed a mean of 10 interactive clicks during a mean total of 59.8 minutes logged in .\
RESULTS	Most required reminder phone calls to complete the sessions .\
RESULTS	Educational level , anxiety score , and home access of the Web site were associated with Web site usage .\
RESULTS	Ten percent of the PSFW group vs. 4.3 % of controls achieved the abstinence end point .\
RESULTS	Among those who completed all 8 sessions , 17.9 % were abstinent , and among women completers , 30.8 % were abstinent .\
CONCLUSIONS	Web-based treatment is a feasible strategy for PLWH smokers , and preliminary findings suggest therapeutic efficacy .\
\
###19782792\
BACKGROUND	To assess the safety of symptom-limited exercise testing in patients with New York Heart Association class II-IV heart failure symptoms due to left ventricular systolic dysfunction , we investigated the frequency of all-cause fatal and nonfatal major cardiovascular ( CV ) events among subjects enrolled in a prospective clinical trial ( HF-ACTION ) .\
BACKGROUND	We hypothesized that exercise testing would be safe , as defined by a rate for all-cause death of < 0.1 per 1,000 tests and a rate of nonfatal CV events < 1.0 per 1,000 tests .\
METHODS	Before enrollment and at 3 , 12 , and 24 months after randomization , subjects were scheduled to complete a symptom-limited graded exercise test with open-circuit spirometry for analysis of expired gases .\
METHODS	To ensure the accurate reporting of exercise test-related events , we report deaths and nonfatal major CV events per 1,000 tests at months 3 , 12 , or 24 after randomization .\
RESULTS	A total of 2,331 subjects were randomized into HF-ACTION .\
RESULTS	After randomization , 2,037 subjects completed 4,411 exercise tests .\
RESULTS	There were no test-related deaths , exacerbation of heart failure or angina requiring hospitalization , myocardial infarctions , strokes , or transient ischemic attacks .\
RESULTS	There was one episode each of ventricular fibrillation and sustained ventricular tachycardia .\
RESULTS	There were no exercise test-related implantable cardioverter defibrillator discharges requiring hospitalization .\
RESULTS	These findings correspond to zero deaths per 1,000 exercise tests and 0.45 nonfatal major CV events per 1,000 exercise tests ( 95 % CI 0.11-1 .81 ) .\
CONCLUSIONS	In New York Heart Association class II-IV patients with severe left ventricular systolic dysfunction , we observed that symptom-limited exercise testing is safe based on no deaths and a rate of nonfatal major CV events that is < 0.5 per 1,000 tests .\
\
###20056436\
OBJECTIVE	Opioids , including remifentanil , have been demonstrated to confer cardiac protection against ischemia reperfusion injury in animals .\
OBJECTIVE	This study evaluated whether remifentanil preconditioning is protective in first-time elective on-pump coronary artery bypass surgery patients receiving a standardized fentanyl ( 25 g/kg in total ) and propofol anesthetic .\
METHODS	A prospective , double blind , randomized , controlled study .\
METHODS	University hospital ; single institution .\
METHODS	Forty patients scheduled for first-time elective , on-pump coronary artery bypass surgery for at least 3 diseased vessels .\
METHODS	Patients randomized to the remifentanil group ( n = 20 ) received a 1 g/kg bolus followed by a 0.5 g/kg/min infusion for 30 minutes after induction but before sternotomy , while the control group ( n = 20 ) received normal saline .\
METHODS	Serial samples for measurement of creatine kinase ( CK-MB ) , cardiac troponin I ( cTnI ) , ischemia-modified albumin ( IMA ) and heart-type fatty-acid-binding protein ( hFABP ) were taken at baseline , prebypass , T = 10 minutes , 2 , 6 , 12 , and 24 hours after cross-clamp release , to assess the degree of myocardial damage .\
RESULTS	Patients in the remifentanil group had lower levels of CK-MB from T = 2 hours to 24 hours , cTnI from T = 10 minutes to T = 12 hours , IMA from T = 10 minutes to T = 2 hours and h-FABP from T = 10 minutes to T = 12 hours ( p < 0.05 ) .\
RESULTS	The time to tracheal extubation was shorter in patients in the remifentanil group .\
RESULTS	The overall lengths of ICU and hospital stays were not different .\
CONCLUSIONS	The addition of remifentanil to the anesthesia regimen reduced the degree of myocardial damage .\
CONCLUSIONS	This incremental benefit may be attributable either to remifentanil itself or to an overall increased opioid dose , the latter may be necessary to trigger cardiac protection .\
\
###21219785\
OBJECTIVE	To compare the image quality and radiation dose of prospectively electrocardiogram ( ECG ) - triggered spiral and sequential acquisition for coronary computed tomographic angiography by dual-source computed tomography .\
METHODS	Sixty patients with suspected or known coronary artery disease were randomly divided into two groups .\
METHODS	Group A underwent prospective ECG-triggering spiral scan and Group B underwent prospective ECG-triggering sequential scan .\
METHODS	Both the image quality and radiation dose of the two groups were compared .\
RESULTS	There was no significant difference in age and body mass index of the two groups .\
RESULTS	The average image quality score was 1.12 0.38 in group A and 1.14 0.38 in group B ( Z = -0.291 , P = 0.771 ) .\
RESULTS	The rates of diagnostic coronary segments for two groups were 98.87 % and 99.56 % respectively ( X2 = 0.59 , P = 0.443 ) .\
RESULTS	The mean radiation dose of group A was significantly lower than that of group B [ ( 1.31 0.30 ) mSv vs. ( 3.36 0.93 ) mSv ; t = 11.47 , P = 0.000 ] .\
CONCLUSIONS	Compared with the prospective ECG-triggered sequential acquisition , the prospective ECG - triggered spiral scan for coronary computed tomographic angiography can remarkably reduce radiation dose without impairing image quality in patients with a low and stable heart rate ( 70 bpm ) .\
\
###16197959\
OBJECTIVE	The evaluation and training of raters who conduct efficacy evaluations in clinical trials is an important methodological variable that is often overlooked .\
OBJECTIVE	Few rater training programs focus on teaching and assessing applied clinical skills , and even fewer have been empirically examined for efficacy .\
OBJECTIVE	The goal of this study was to develop a comprehensive , standardized , interactive rater training program using new technologies , and to compare the relative effectiveness of this approach to `` traditional '' rater training in a multi-center clinical trial .\
METHODS	12 sites from a 22 site multi-center study were randomly selected to participate ( 6 = traditional , 6 = enriched ) .\
METHODS	Traditional training consisted of an overview of scoring conventions , watching and scoring videotapes with discussion , and observation of interviews in small groups with feedback .\
METHODS	Enriched training consisted of an interactive web tutorial , and live , remote observation of trainees conducting interviews with real or standardized patients , via video - or teleconference .\
METHODS	Outcome measures included a didactic exam on conceptual knowledge and blinded ratings of trainee 's audiotaped interviews .\
RESULTS	A significant difference was found between enriched and traditional training on pre-to-post training improvement on didactic knowledge , t ( 27 ) = 4.2 , p < 0.0001 .\
RESULTS	Enriched trainees clinical skills also improved significantly more than traditional trainees , t ( 56 ) = 2.1 , p = 0.035 .\
RESULTS	All trainees found the applied training helpful , and wanted similar web tutorials with other scales .\
CONCLUSIONS	Results support the efficacy of enriched rater training in improving both conceptual knowledge and applied skills .\
CONCLUSIONS	Remote technologies enhance training efforts , and make training accessible and cost-effective .\
CONCLUSIONS	Future rater training efforts should be subject to empirical evaluation , and include training on applied skills .\
\
###24607889\
OBJECTIVE	We aimed to compare the clinical outcomes of intra-articular calcaneus fractures treated with open reduction and internal fixation with conventional plate via L-shaped lateral approach ( routine treatment ) versus those with percutaneous plate via a sinus tarsi approach ( minimally invasive treatment ) .\
METHODS	One hundred and seventeen displaced intra-articular calcaneal fractures in 108 patients from January 2007 and September 2010 were randomly allocated to receive routine treatment ( 49 patients ) or minimally invasive treatment ( 59 patients ) .\
METHODS	Operative time , preoperative and postoperative calcaneal height , width , length , Bhlers angle , Gissanes angle , and incision healing were recorded .\
METHODS	Maryland foot score system was used to evaluate clinical functional outcomes .\
RESULTS	The operative time of minimally invasive group was significantly shorter than that of the routine group [ 46-80 min ( mean , 62 min ) vs 65-110 min ( mean , 93 min ) , p < 0.01 ] .\
RESULTS	Postoperative X-ray showed the calcaneal height , width , length , Bhlers angle and Gissanes angle were significantly improved in both two groups , and no significant difference was observed between two groups postoperatively .\
RESULTS	No feet developed wound complications in minimally invasive group , but incision complications occurred in 8 feet in routine group .\
RESULTS	The excellent and good rate according to the Maryland foot score was significantly higher in minimally invasive group than that in the routine group ( 93.8 % vs 86.8 % ) .\
CONCLUSIONS	Compared with L-shaped lateral approach treatment of displaced intra-articular calcaneal fractures , sinus tarsi approach for the reduction and internal fixation with percutaneous plate seems to be more safe and effective , with satisfactory clinical therapeutic effects and without postoperative complications .\
\
###9132194\
OBJECTIVE	To evaluate the safety and efficacy of intranasal diamorphine as an analgesic for use in children in accident and emergency ( A&E ) .\
METHODS	A prospective , randomised clinical trial with consecutive recruitment of patients aged between 3 and 16 years with clinically suspected limb fractures .\
METHODS	One group received 0.1 mg/kg intranasal diamorphine , and the other group received 0.2 mg/kg intramuscular morphine .\
METHODS	At 0 , 5 , 10 , 20 , and 30 minutes pain scores , Glasgow coma score , and peripheral oxygen saturations were recorded ; parental acceptability was assessed at 30 minutes .\
RESULTS	58 children were recruited , with complete data collection in 51 ( 88 % ) ; the median summed decrease in pain score was better for intranasal diamorphine than intramuscular morphine ( 9 v 8 ) , though this was not significant ( P = 0.4 , Mann-Whitney U test ) .\
RESULTS	The episode was recorded as `` acceptable '' in all parents whose child received intranasal diamorphine , compared with only 55 % of parents in the intramuscular morphine group ( P < 0.0001 , Fisher 's exact test ) .\
RESULTS	There was no incidence of decreased peripheral oxygen saturation or depression in the level of consciousness in any patient .\
CONCLUSIONS	Intranasal diamorphine is an effective , safe , and acceptable method of analgesia for children requiring opiates in the A & E department .\
\
###10791670\
OBJECTIVE	To determine if there are differences in healing , complications , or number of procedures required to obtain union among open and closed tibia fractures treated with intramedullary ( IM ) nails inserted with and without reaming .\
METHODS	Prospective , surgeon-randomized comparative study .\
METHODS	Level One trauma center .\
METHODS	Ninety-four consecutive patients with unstable closed and open ( excluding Gustilo Grade IIIB and IIIC ) fractures of the tibial shaft treated with IM nail insertion between November 1 , 1994 , and June 30 , 1997 .\
METHODS	Interlocked IM nail insertion with and without medullary canal reaming .\
METHODS	Time to union , type and incidence of complications , and number of secondary procedures performed to obtain union .\
RESULTS	For open fractures , there were no significant differences in the time to union or number of additional procedures performed to obtain union in patients with reamed nail insertion compared with those without reamed insertion .\
RESULTS	A higher percentage of closed fractures were healed at four months after reamed nail insertion compared with unreamed insertion ( p = 0.040 ) , but there was not a difference at six and twelve months .\
RESULTS	More secondary procedures were needed to obtain union after unreamed nail insertion for the treatment of closed tibia fractures , but the difference was not statistically significant given the limited power of our study ( p = 0.155 ) .\
RESULTS	Broken screws were seen only in patients treated with smaller-diameter nails inserted without reaming , and the majority occurred in patients who were noncompliant with weight-bearing restrictions .\
RESULTS	There were no differences in rates of infection or compartment syndrome .\
CONCLUSIONS	Our findings support the use of reamed insertion of IM nails for the treatment of closed tibia fractures , which led to earlier time to union without increased complications .\
CONCLUSIONS	In addition , canal reaming did not increase the risk of complications in open tibia fractures .\
\
###24923300\
BACKGROUND	Countries in sub-Saharan Africa ( SSA ) are experiencing an epidemic of cardiovascular disease ( CVD ) propelled by rapidly increasing rates of hypertension .\
BACKGROUND	Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs .\
BACKGROUND	Although SSA bears 24 % of the global disease burden , it has only 3 % of the global health workforce .\
BACKGROUND	Given such limited resources , cost-effective strategies , such as task shifting , are needed to mitigate the rising CVD epidemic in SSA .\
BACKGROUND	Ghana , a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization ( WHO ) task-shifting strategy .\
BACKGROUND	This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage , on blood pressure ( BP ) reduction .\
METHODS	Using a cluster randomized design , 32 community health centers ( CHCs ) and district hospitals in Ghana will be randomized to either the intervention group ( 16 CHCs ) or the control group ( 16 CHCs ) .\
METHODS	A total of 640 patients with uncomplicated hypertension ( BP 140-179/90 -99 mm Hg and absence of target organ damage ) will be enrolled in this study ( 20 patients per CHC ) .\
METHODS	The intervention consists of WHO Package of CV risk assessment , patient education , initiation and titration of antihypertensive medications , behavioral counseling on lifestyle behaviors , and medication adherence every three months for 12 months .\
METHODS	The primary outcome is the mean change in systolic BP from baseline to 12 months .\
METHODS	The secondary outcomes are rates of BP control at 12 months ; levels of physical activity , percent change in weight , and dietary intake of fruits and vegetables at 12 months ; and sustainability of intervention effects at 24 months .\
METHODS	All outcomes will be assessed at baseline , six months and 12 months .\
METHODS	Trained community health nurses will deliver the intervention as part of Ghana 's community-based health planning and services ( CHPS ) program .\
CONCLUSIONS	Findings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in resource-poor settings .\
BACKGROUND	NCT01802372 .\
\
###11114277\
OBJECTIVE	To investigate the effects of 21 weeks ' progressive strength training on neuromuscular function and subjectively perceived symptoms in premenopausal women with fibromyalgia ( FM ) .\
METHODS	Twenty one women with FM were randomly assigned to experimental ( FM ( T ) ) or control ( FM ( C ) ) groups .\
METHODS	Twelve healthy women served as training controls ( H ( T ) ) .\
METHODS	The FM ( T ) and H ( T ) groups carried out progressive strength training twice a week for 21 weeks .\
METHODS	The major outcome measures were muscle strength and electromyographic ( EMG ) recordings .\
METHODS	Secondary outcome measures were pain , sleep , fatigue , physical function capacity ( Stanford Health Assessment Questionnaire ) , and mood ( short version of Beck 's depression index ) .\
RESULTS	Female FM ( T ) subjects increased their maximal and explosive strength and EMG activity to the same extent as the H ( T ) group .\
RESULTS	Moreover , the progressive strength training showed immediate benefits on subjectively perceived fatigue , depression , and neck pain of training patients with FM .\
CONCLUSIONS	The strength training data indicate comparable trainability of the neuromuscular system of women with FM and healthy women .\
CONCLUSIONS	Progressive strength training can safely be used in the treatment of FM to decrease the impact of the syndrome on the neuromuscular system , perceived symptoms , and functional capacity .\
CONCLUSIONS	These results confirm the opinion that FM syndrome has a central rather than a peripheral or muscular basis .\
\
###10774589\
BACKGROUND	To determine the dosage requirements and pharmacokinetics of atevirdine , a non-nucleoside reverse transcriptase inhibitor and its N-dealkylated metabolite ( N-ATV ) during phase I studies in patients receiving atevirdine alone or in combination with zidovudine .\
METHODS	Two open label , phase I studies conducted by the adult AIDS Clinical Trials Group ( ACTG ) in which atevirdine was administered every 8 h with weekly dosage adjustments to attain targeted trough plasma atevirdine concentrations .\
METHODS	Five Adult AIDS Clinical Trials Units .\
METHODS	Fifty patients ( ACTG 199 ; n = 20 and ACTG 187 ; n = 30 ) with HIV-1 infection and < or = 500 CD4 + lymphocytes/mm3 .\
METHODS	ACTG 199 ; 12 weeks of therapy with atevirdine ( dose-adjusted to achieve plasma trough atevirdine concentrations of 5-10 microM ) and zidovudine ( 200 mg every 8 h ) .\
METHODS	ACTG 187 : 12 weeks of atevirdine monotherapy with atevirdine doses adjusted to achieve escalating , targeted trough plasma concentration ranges ( 5-13 , 14-22 , and 23-31 microM ) .\
METHODS	ACTG 199 : atevirdine , N-ATV and zidovudine trough determinations weekly ( all patients ) and intensive pharmacokinetics ( selected patients ) prior to and at 6 and 12 weeks during combination therapy .\
METHODS	ACTG 187 : atevirdine and N-ATV trough concentrations over a 12 week period .\
METHODS	Intensive pharmacokinetic studies were conducted prior to and at 4 and/or 8 weeks during atevirdine monotherapy in female patients .\
RESULTS	Atevirdine plasma concentrations demonstrated considerable interpatient variability which was minimized by the adjustment of maintenance doses ( range : 600-3900 mg/day ) to achieve the desired trough concentrations .\
RESULTS	In ACTG 187 , the mean number of weeks to attain the target value , and the percentage of patients who attained the target , was group I ( 5-11 microM ) : 2.7 + / -2.4 weeks ( 92 % ) ; group II ( 12-21 microM ) : 2.6 + / -1.8 ( 64 % ) ; and group III ( 22-31 microM ) : 7.0 + / -5.6 weeks ( 27 % ) .\
RESULTS	In ACTG 199 it was 3.2 + / -5.2 weeks ( 95 % ) to achieve a 5-10 microM trough .\
RESULTS	Atevirdine demonstrated a mono - or bi-exponential decline among most of the patients studied after the first dose .\
RESULTS	During multiple-dosing a number of patterns of atevirdine disposition were observed including ; rapid absorption with Cmax at 0.5-1 h , delayed absorption with Cmax at 3-4 h ; minimal Cmax to Cmin fluctuation and Cmax to Cmin ratios of > 4 .\
RESULTS	N-ATV ( an inactive metabolite ) patterns were characterized on day one by rapid appearance of the metabolite which peaked at 2-3 h after the dose and declined in a mono - or bi-exponential manner .\
RESULTS	At steady-state N-ATV patterns demonstrated minimal Cmax to Cmin fluctuations with some of the patients having more stable plasma N-ATV concentrations , while others had greater fluctuations week to week .\
CONCLUSIONS	Considerable interpatient variability was noted in the pharmacokinetics of atevirdine .\
CONCLUSIONS	The variation in drug disposition was reflected in the range of daily doses required to attain the targeted trough concentrations .\
CONCLUSIONS	Atevirdine metabolism did not appear to reach saturation during chronic dosing in many of our patients , as reflected by the pattern of N-ATV/ATV ratios in plasma and saturation was not an explanation for the variation in dosing requirements .\
CONCLUSIONS	No apparent differences were noted between males and females , and atevirdine did not appear to influence zidovudine disposition .\
\
###25376971\
BACKGROUND	The pectoral nerves ( Pecs ) block types I and II are novel techniques to block the pectoral , intercostobrachial , third to sixth intercostals , and the long thoracic nerves .\
BACKGROUND	They may provide good analgesia during and after breast surgery .\
BACKGROUND	Our study aimed to compare prospectively the quality of analgesia after modified radical mastectomy surgery using general anesthesia and Pecs blocks versus general anesthesia alone .\
METHODS	One hundred twenty adult female patients scheduled for elective unilateral modified radical mastectomy under general anesthesia were randomly allocated to receive either general anesthesia plus Pecs block ( Pecs group , n = 60 ) or general anesthesia alone ( control group , n = 60 ) .\
RESULTS	Statistically significant lower visual analog scale pain scores were observed in the Pecs group than in the control group patients .\
RESULTS	Moreover , postoperative morphine consumption in the Pecs group was lower in the first 12 hours after surgery than in the control group .\
RESULTS	In addition , statistically significant lower intraoperative fentanyl consumption was observed in the Pecs group than in the control group .\
RESULTS	In the postanesthesia care unit , nausea and vomiting as well as sedation scores were lower in the Pecs group compared with the control group .\
RESULTS	Overall , postanesthesia care unit and hospital stays were shorter in the Pecs group than in the control group .\
CONCLUSIONS	The combined Pecs I and II block is a simple , easy-to-learn technique that produces good analgesia for radical breast surgery .\
\
###18597068\
OBJECTIVE	The aim of the study was to compare the effect of different dietary interventions on alanine aminotransferase ( ALT ) in obese patients with diabetes .\
METHODS	A post hoc analysis of an open label , parallel design , quasi-randomised ( allocation by alternation ) , controlled trial , conducted in Israel .\
METHODS	Obese patients with diabetes ( n = 259 ) , treated in the community , were centrally allocated to one of three diets : ( 1 ) the 2003 recommended American Diabetes Association diet ( ADA ) : 50-55 % carbohydrate , 30 % fat and 20 % protein , n = 85 ; ( 2 ) a low glycaemic index ( LGI ) diet : 50-55 % LGI carbohydrate , 30 % fat , 15-20 % protein , n = 89 ; or ( 3 ) a modified Mediterranean diet ( MMD ) : 35 % LGI carbohydrate , 45 % fat that was high in monounsaturated fat , 15-20 % protein , n = 85 .\
METHODS	ALT was measured at 6 and 12 months .\
RESULTS	ALT levels decreased in all arms ; however , the MMD was associated with the lowest ALT levels at month 6 ( n = 201 : ADA n = 64 , LGI n = 73 , MMD n = 64 ) and month 12 of follow-up ( n = 179 ) .\
RESULTS	At 12 months mean ALT levels were 19.8 + / - 1.4 U/l in the ADA diet arm ( n = 54 ) , 18.0 + / - 1.5 U/l in the LGI diet arm ( n = 64 ) and 14.4 + / - 1.7 in the MMD arm ( n = 61 , p < 0.001 ) .\
RESULTS	Evidence for an effect of diet on ALT levels persisted when controlling for post-randomisation changes in waist to hip ratio , BMI , homeostasis model assessment ( HOMA ) or triacylglycerol .\
CONCLUSIONS	A Mediterranean diet may have a beneficial effect on liver steatosis in obese patients with diabetes .\
CONCLUSIONS	Results of trials assessing the effect of dietary composition on clinical outcomes should be awaited before a decisive conclusion can be reached .\
CONCLUSIONS	In addition to clinical outcomes , such studies should address the issue of primary prevention of steatosis in high-risk and healthy individuals .\
\
###16854753\
OBJECTIVE	To assess early intervention with pimecrolimus combined with corticosteroid ( CS ) for major flares in patients with severe atopic dermatitis ( AD ) .\
METHODS	In this 6-month , double-blind , multicenter , randomized , vehicle-controlled , parallel-group in 35 US centers , 275 children aged 3 months to 11 years with mild to severe AD applied the study medication twice daily at first signs/symptoms of AD .\
METHODS	For major flares not controlled with study medication , a mid-potency CS cream replaced the evening study drug for up to 3 weeks .\
METHODS	The percentage of subjects with no major flares was the main outcome measure .\
RESULTS	Pimecrolimus reduced the major flare incidence and prolonged flare-free intervals .\
RESULTS	Significantly more pimecrolimus subjects ( 52 % ) had no major flares compared with vehicle subjects ( 34 % ; p = 0.007 ) .\
RESULTS	Pimecrolimus significantly delayed the first flare ( median , 53 days vs 13 days ; p < 0.001 ) , and increased the time between flares ( median , 31 days vs 15 days ) .\
RESULTS	Additionally , there was earlier pruritus improvement ( median , day 3 vs day 6 ; p = 0.034 ) in the pimecrolimus group , as well as a reduced need for CS by 37 % ( p = 0.020 ) [ corrected ] Adverse events ( AEs ) incidence and type were comparable between groups .\
RESULTS	Combination therapy with pimecrolimus used at half the recommended dose did not shorten the mean flare duration or alter the AE profile .\
CONCLUSIONS	Early treatment of signs/symptoms of AD with pimecrolimus cream 1 % provided an effective steroid-sparing option that reduced the incidence of major flares .\
\
###24084630\
BACKGROUND	There are few cost evaluation studies of orthodontic retention treatment .\
BACKGROUND	The aim of this study was to compare the costs in a randomized controlled trial of three retention methods during 2 years of retention treatment .\
METHODS	To determine which alternative has the lower cost , a cost-minimization analysis ( CMA ) was undertaken , based on that the outcome of the treatment alternatives was equivalent .\
METHODS	The study comprised 75 patients in 3 groups consisting of 25 each .\
METHODS	The first group had a vacuum-formed retainer ( VFR ) in the maxilla and a cuspid retainer in the mandible ( group V-CTC ) , the second group had a VFR in the maxilla combined with stripping of the incisors and cuspids in the mandible ( group V-S ) , and the third group had a prefabricated positioner ( group P ) .\
METHODS	Direct cost ( premises , staff salaries , material and laboratory costs ) and indirect costs ( loss of time at school ) were calculated .\
METHODS	Societal costs were defined as the sum of direct and indirect costs .\
RESULTS	The societal costs/patient for scheduled appointments for 2 years of retention treatment in group V-CTC were 497 , group V-S 451 and group P 420 .\
RESULTS	Societal costs for unscheduled appointments in group V-CTC were 807 and in group V-S 303 .\
RESULTS	In group P , there were no unscheduled appointments .\
CONCLUSIONS	After 2 years of retention in compliant patients , the cuspid retainer was the least cost-effective retention appliance .\
CONCLUSIONS	The CMA showed that for a clinically similar result , there were differences in societal costs , but treatment decisions should always be performed on an individual basis .\
\
###12913687\
OBJECTIVE	Based on previous studies showing that warming decreases trauma pain in emergency care we hypothesized that local active warming of the abdomen and lower back region could decrease pain in acute renal colic cases during emergency transport .\
METHODS	After obtaining informed consent 100 patients were divided into 2 groups , including those who received active warming of the abdomen and lower back region ( 42C ) and those who received no warming .\
METHODS	Pain , nausea and anxiety were rated by the patients using visual analog scales .\
METHODS	Statistical evaluation was performed using the t test with p < 0.05 considered significant .\
RESULTS	In group 1 a significant pain decrease was recorded in all cases using a visual analog score ( VAS ) ( 82.7 + / - 9.5 to 36.3 + / - 16.0 mm VAS , p < 0.01 ) .\
RESULTS	In group 2 patient pain scores remained comparable ( 81.8 + / - 13.0 to 80.6 + / - 12.3 mm VAS ) .\
RESULTS	In group 1 anxiety significantly decreased ( 79.0 + / - 8.9 and 30.7 + / - 14.1 mm VAS before and after treatment , respectively , p < 0.01 ) .\
RESULTS	In group 2 a nonsignificant change in score was noted ( 79.7 + / - 20.5 to 75.2 + / - 19.7 mm VAS ) .\
RESULTS	In group 1 a significant decrease in nausea was recorded in all cases ( 85.7 + / - 11.2 to 40.6 + / - 23.0 mm VAS , p < 0.01 ) .\
RESULTS	In group 2 patient nausea scores remained comparable ( 79.2 + / - 22.0 to 80.3 + / - 22.4 mm VAS , respectively ) .\
CONCLUSIONS	Local active warming is an effective and easy to learn pain treatment for patients with acute renal colic in emergency care .\
\
###8162670\
BACKGROUND	Fluorinated ether anesthetic hepatotoxicity and nephrotoxicity are mediated by cytochrome P450-catalyzed oxidative metabolism .\
BACKGROUND	Metabolism of the volatile anesthetic enflurane to inorganic fluoride ion by human liver microsomes in vitro is catalyzed predominantly by the cytochrome P450 isoform CYP2E1 .\
BACKGROUND	This investigation tested the hypothesis that P450 2E1 is also the isoform responsible for human enflurane metabolism in vivo .\
BACKGROUND	Disulfiram , which is converted in vivo to a selective inhibitor of P450 2E1 , was used as a metabolic probe for P450 2E1 .\
METHODS	Twenty patients undergoing elective surgery were randomized to receive disulfiram ( 500 mg orally ; n = 10 ) or nothing ( control subjects ; n = 10 ) the evening before surgery .\
METHODS	All patients received a standard anesthetic of enflurane ( 2.2 % end-tidal ) in oxygen for 3 hours .\
METHODS	Blood enflurane concentrations were measured by gas chromatography .\
METHODS	Plasma and urine fluoride concentrations were quantitated by ion-selective electrode .\
RESULTS	Patient groups were similar with respect to age , weight , gender , duration of surgery , and blood loss .\
RESULTS	Total enflurane dose , measured by cumulative end-tidal enflurane concentrations ( 3.9 to 4.1 MAC-hr ) and by blood enflurane concentrations , was similar in both groups .\
RESULTS	Plasma fluoride concentrations increased from 3.6 + / - 1.5 mumol/L ( baseline ) to 24.3 + / - 3.8 mumol/L ( peak ) in untreated patients ( mean + / - SE ) .\
RESULTS	Disulfiram treatment completely abolished the rise in plasma fluoride concentration .\
RESULTS	Urine fluoride excretion was similarly significantly diminished in disulfiram-treated patients .\
RESULTS	Fluoride excretion in disulfiram-treated patients was 62 + / - 10 and 61 + / - 12 mumol on days 1 and 2 , respectively , compared with 1090 + / - 180 and 1200 + / - 220 mumol in control subjects ( p < 0.05 on each day ) .\
CONCLUSIONS	Disulfiram prevented fluoride ion production after enflurane anesthesia .\
CONCLUSIONS	These results suggest that P450 2E1 is the predominant P450 isoform responsible for human clinical enflurane metabolism in vivo .\
\
###24779438\
BACKGROUND	Many cancer patients have problems performing activities of daily living ( ADL ) .\
BACKGROUND	A randomised controlled trial was designed to examine the effects of an ADL intervention in addition to standard treatment and care in a hospital setting .\
BACKGROUND	The objective of this article was to present the study and to analyse the feasibility of the recruitment process and the intervention .\
METHODS	Adult disabled cancer patients at Nstved Hospital in Denmark were enrolled between 1 March 2010 and 30 June 2011 and randomised into an ADL intervention or to a control group .\
METHODS	The intervention was performed by occupational therapists .\
METHODS	The feasibility of the recruitment was analysed with regard to success in achieving the estimated number of participants and identification of barriers , and feasibility of the intervention was based on calculations of patient attendance and patient acceptability .\
METHODS	The primary outcome of the randomised controlled trial was patients ' health-related quality of life 2 and 8weeks after baseline .\
RESULTS	A total of 118 disabled cancer patients were enrolled in the study over a time span of 16months .\
RESULTS	Very few meetings between occupational therapist and patient were cancelled .\
RESULTS	Time spent on the intervention varied considerably , but for the majority of patients , time consumption was between 1-3 hours .\
CONCLUSIONS	Despite difficulties with recruitment , participation was considered feasible and the intervention was accepted among patients .\
CONCLUSIONS	Missing data in the follow-up period were mostly due to death among participants .\
CONCLUSIONS	Very few participants declined to complete questionnaires during follow-up .\
\
###18068940\
OBJECTIVE	To meet the need for an interactive product on exercise during pregnancy and postpartum , we developed and evaluated a personally tailored multimedia CD-ROM .\
METHODS	Pregnant and postpartum women , who were randomly assigned to either the experimental group ( PregXercise CD-ROM ) or the control group ( CD-ROM with neutral content ) , navigated through the CD-ROM for 1 h. Main outcomes were exercise self-efficacy and knowledge .\
RESULTS	In analyses of covariance , compared with the control group , the experimental group had significant increases in self-efficacy and knowledge .\
CONCLUSIONS	The multimedia CD-ROM delivering information about exercise motivation , guidelines , and prescription was effective in improving exercise self-efficacy and knowledge .\
CONCLUSIONS	Our preliminary results illustrate that healthcare professionals and researchers may use interactive multimedia for improving exercise behavior and related outcomes with pregnant and postpartum women .\
\
###11116420\
BACKGROUND	The role of laparoscopic colon resection in the management of colon cancer is unclear .\
BACKGROUND	The aims of this study were to compare perioperative results and long-term outcomes in patients randomized to either open ( O ) or laparoscopically assisted ( LA ) colon resection for colon cancer .\
METHODS	A prospective randomized trial comparing O to LA colon resection was conducted from January 1993 to November 1995 .\
METHODS	Preoperative workup , intraoperative results , complications , length of stay , pathologic findings , and long-term outcomes were compared between the two groups .\
METHODS	Statistical analysis was performed with t-test .\
METHODS	Follow-up periods ranged from 3.5 to 6.3 years ( mean , 4.9 years ) .\
RESULTS	No port-site or abdominal wall recurrences were noted in any patients .\
RESULTS	[ table : see text ]\
CONCLUSIONS	These results suggest that laparoscopically assisted colon resection for malignant disease can be performed safely , with morbidity , mortality , and en bloc resections comparable with those of open laparotomy .\
CONCLUSIONS	Long-term ( 5-year ) follow-up assessment shows similar outcomes in both groups of patients , demonstrating definite perioperative advantages with LA surgery and no perioperative or long-term disadvantages .\
\
###17402473\
BACKGROUND	Hyperhydration , prior to prolonged moderate-intensity exercise simulating the 2nd day of a 3-day equestrian event ( E3DEC ) , may induce arterial hypoxaemia detrimental to performance .\
OBJECTIVE	Because moderate-intensity exercise does not induce arterial hypoxaemia in healthy horses , the effects of pre-exercise hypervolaemia on arterial oxygenation were examined during a prolonged exercise protocol .\
METHODS	Blood-gas studies were carried out on 7 healthy , exercise-trained Thoroughbred horses in control and hyperhydration experiments .\
METHODS	The study conformed to a randomised crossover design .\
METHODS	The sequence of treatments was randomised for each horse and 7 days were allowed between studies .\
METHODS	Hyperhydration was induced by administering 0.425 g/kg bwt NaCl via nasogastric tube followed by free access to water .\
METHODS	The exercise protocol was carried out on a treadmill set at a 3 % uphill grade and consisted of walking at 2 m/sec for 2 min , trotting for 10 min at 3.7 m/sec , galloping for 2 min at 14 m/sec ( which elicited maximal heart rate ) , trotting for 20 min at 3.7 m/sec , walking for 10 min at 1.8 m/sec , cantering for 8 min at 9.2 m/sec , trotting for 1 min at 5 m/sec and walking for 5 min at 2 m/sec .\
RESULTS	NaCl administration induced a significant mean + / - s.e. 15.5 + / - 1.1 % increase in plasma volume as indicated by a significant reduction in plasma protein concentration .\
RESULTS	In either treatment , whereas arterial hypoxaemia was not observed during periods of submaximal exercise , short-term maximal exertion caused significant arterial hypoxaemia , desaturation of haemoglobin , hypercapnoea , and acidosis in both treatments .\
RESULTS	However , the magnitude of exercise-induced arterial hypoxaemia , desaturation of haemoglobin , hypercapnoea , and acidosis in both treatments remained similar , and statistically significant differences between treatments could not be demonstrated .\
CONCLUSIONS	It was concluded that significant pre-exercise expansion of plasma volume by this method does not adversely affect the arterial oxygenation of horses performing a prolonged exercise protocol simulating the 2nd day of an E3DEC .\
\
###9222948\
OBJECTIVE	To evaluate the influence of a history of arterial hypertension on the efficacy of the angiotensin converting enzyme ( ACE ) inhibitor trandolapril in patients with acute myocardial infarction ( AMI ) and left ventricular dysfunction .\
METHODS	A retrospective analysis of data from the Trandolapril Cardiac Event ( TRACE ) study .\
METHODS	The TRACE study was a randomized , double-blind , placebo-controlled study in which patients with an enzyme-verified AMI and ejection fraction < or = 35 % were assigned randomly to be administered oral trandolapril or placebo 3-7 days after the infarction .\
METHODS	Of 1749 patients who entered the study , 400 ( 23 % ) had a history of arterial hypertension .\
METHODS	The mean follow-up time was 26 months .\
METHODS	Mortality from any cause .\
METHODS	Secondary endpoints were sudden death , cardiovascular mortality , reinfarction and development of severe heart failure .\
RESULTS	Of the patients in the hypertensive group , 173 ( 43 % ) died during follow-up , versus 500 ( 37 % ) in the normotensive group .\
RESULTS	Treatment with trandolapril resulted in a relative risk of death from any cause for the hypertensive group of 0.59 ( 96 % confidence interval 0.44-0 .80 ) , versus 0.85 ( 0.72-1 .02 ) for normotensive patients .\
RESULTS	In a multivariate analysis , treatment with trandolapril was associated with a reduction in mortality among patients with a history of hypertension ( P = 0.03 ) .\
CONCLUSIONS	In this retrospective analysis , ACE inhibition after AMI complicated with left ventricular dysfunction was of greater benefit to patients with a history of arterial hypertension .\
CONCLUSIONS	ACE inhibition might be of particular importance in this group of patients but further studies to establish the clinical impact are necessary .\
\
###19941542\
OBJECTIVE	This paper is a report of a study conducted to examine the effect of participating in an education program on burnout for mothers of children with an intellectual disability .\
BACKGROUND	Mothers with an intellectually disabled child are prone to suffer from excessive stress and burnout .\
BACKGROUND	There is limited evidence for the effectiveness of education interventions aimed at reducing burnout levels in this population .\
METHODS	After baseline screening , mothers who agreed to participate ( n = 90 ) were randomized to an intervention or control group .\
METHODS	The intervention group participated in an interactive education programme for 1 hour , in addition to using an educational booklet designed and presented by the researchers .\
METHODS	The booklet contained information about the characteristics of intellectually disabled children , the specific health care and education they require , non-profit organizations and foundations providing assistance , and ways in which mothers can cope with stress .\
METHODS	The control group received the same intervention separately after completing the post-test .\
METHODS	The study was carried out from 2004 to 2005 .\
RESULTS	Intervention group members reported fewer episodes of emotional burnout compared to the control group , indicating that participation in a nursing education programme reduced the level of burnout experienced by mothers who have an intellectually disabled child .\
RESULTS	There were no effects of the education programme on perceptions of personal success , i.e. mother 's feelings of competence and successful achievement in care of their intellectually disabled child .\
CONCLUSIONS	Nurse-administered education should be provided for mothers who have an intellectually disabled child in order to reduce the degree of emotional burnout that these mothers typically experience .\
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###18806043\
BACKGROUND	Phenylephrine and ephedrine are both used to maintain arterial blood pressure during spinal anesthesia for cesarean delivery .\
BACKGROUND	Usually , either drug is given alone but several previous studies have described combining the drugs .\
BACKGROUND	However , the effect of varying the proportion of vasopressors in such combinations has not been reported .\
METHODS	One-hundred-twenty-five parturients having spinal anesthesia for elective cesarean delivery were randomized to receive an IV infusion of phenylephrine and ephedrine combined in one of five different concentration ratios .\
METHODS	Assuming phenylephrine 100 microg to be approximately equipotent to ephedrine 8 mg , the groups contained the proportional potency equivalent of 100 % , 75 % , 50 % , 25 % or 0 % of phenylephrine and 0 % , 25 % , 50 % , 75 % or 100 % , respectively , of ephedrine .\
METHODS	The infusions were adjusted to maintain systolic blood pressure ( SBP ) near baseline until uterine incision .\
METHODS	Hemodynamic changes and umbilical cord blood gases were compared .\
RESULTS	As the proportion of phenylephrine decreased and proportion of ephedrine increased among the groups , the following significant trends were detected : the incidences of hypotension and nausea/vomiting increased , the median magnitude of deviations of SBP above or below baseline and the bias for SBP to be above baseline increased , maternal heart rate was faster , fetal pH and base excess decreased , umbilical arterial oxygen content decreased and umbilical venous Po2 increased .\
CONCLUSIONS	When varying combinations of phenylephrine and ephedrine were given by infusion to maintain arterial blood pressure during spinal anesthesia for cesarean delivery , as the proportion of phenylephrine decreased and the proportion of ephedrine increased , hemodynamic control was reduced and fetal acid-base status was less favorable .\
CONCLUSIONS	Combinations of phenylephrine and ephedrine appear to have no advantage compared with phenylephrine alone when administered by infusion for the prevention of hypotension associated with spinal anesthesia for cesarean delivery .\
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###18298907\
BACKGROUND	Myocardial perfusion associates with clinical syndromes and prognosis .\
BACKGROUND	Adenosine could improve myocardial perfusion of acute myocardial infarction within 6 hours , but few data are available on late perfusion of myocardial infarction ( MI ) .\
BACKGROUND	This study aimed at quantitatively evaluating the value of intracoronary adenosine improving myocardial perfusion in late reperfused MI with myocardial contrast echocardiography ( MCE ) .\
METHODS	Twenty-six patients with anterior wall infarcts were divided randomly into 2 groups : adenosine group ( n = 12 ) and normal saline group ( n = 14 ) .\
METHODS	Their history of myocardial infarction was about 3 - 12 weeks .\
METHODS	Adenosine or normal saline was given when the guiding wire crossed the lesion through percutaneous coronary intervention ( PCI ) , then the balloon was dilated and stent ( Cypher/Cypher select ) was implanted at the lesion .\
METHODS	Contrast pulse sequencing MCE with Sonovue contrast via the coronary route was done before PCI and 30 minutes after PCI .\
METHODS	Video densitometry and contrast filled-blank area were calculated with the CUSQ off-line software .\
METHODS	Heart function and cardiac events were followed up within 30 days .\
RESULTS	Perfusion in the segments of the criminal occlusive coronary artery in the adenosine group was better than that in the saline group ( 5.71 + / - 0.29 vs 4.95 + / - 1.22 , P < 0.05 ) .\
RESULTS	Ischemic myocardial segment was deminished significantly after PCI , but the meliorated area was bigger in the adenosine group than in the saline group ( ( 1.56 + / - 0.60 ) cm ( 2 ) vs ( 1.02 + / - 0.56 ) cm ( 2 ) , P < 0.05 ) .\
RESULTS	The video densitometry in critical segments was also improved significantly in the adenosine group ( 5.53 + / - 0.36 vs 5.26 + / - 0.35 , P < 0.05 ) .\
RESULTS	Left ventricular ejection fraction ( LVEF ) was improved in all patients after PCI , but EF was not significant between the two groups ( ( 67 + / - 6 ) % vs ( 62 + / - 7 ) % , P > 0.05 ) .\
RESULTS	There was no in-hospital or 30-day major adverse cardiac event ( MACE ) in the adenosine group but 3 MACE in the saline group in 30 days after PCI .\
CONCLUSIONS	Adenosine could improve myocardial microvascular perfusion in the late reopening of an occluded infarct related artery ( 3 to 12 weeks after AMI ) and clinical outcome in the follow-up period , and myocardial microvascular perfusion is a powerful predictor of clinical events .\
\
###19819529\
OBJECTIVE	To evaluate safety and patients ' comfort by using the ureteral stent symptom questionnaire .\
OBJECTIVE	Ureteral stents are used to provide upper urinary-tract drainage .\
METHODS	A total of 133 JJ-ureteral stents with and without antireflux-membrane valve as consecutive referrals for therapy of hydronephrosis have been inserted .\
METHODS	Four weeks after insertion of the ureteral stent , the patients were asked about pain while urination , flank pain due to reflux , and the comparison with former stents .\
METHODS	Ultrasound of the kidney for hydronephrosis grade and creatinine value as follow-up have been documented .\
METHODS	Statistical analysis included chi ( 2 ) test after Pearson correlation computed and performed by SPSS software .\
RESULTS	We found a high correlation between the JJ-ureteral stent used and the detection of a hydronephrosis ( P = .004 ) .\
RESULTS	More patients who had a JJ-ureteral stent without valve complained of flank pain ( P < .0005 ) and pain in the bladder ( P < .0005 ) .\
RESULTS	Patients who had a ureteral stent before were asked to compare new stents with the former ones .\
RESULTS	No patients with a JJ-ureteral stent with valve found this one to be worse than what they had before .\
CONCLUSIONS	JJ-stent related symptoms are a major problem for these patients .\
CONCLUSIONS	New stent designs and materials will be developed in the future to reduce stent-related morbidity and improve patient comfort .\
CONCLUSIONS	JJ-ureteral stents with an antireflux-membrane valve have a lower complication rate and provide a higher patient comfort compared with stents without valve .\
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###24080858\
OBJECTIVE	To evaluate changes of retinal nerve fiber layer ( RNFL ) thickness after panretinal photocoagulation ( PRP ) in red versus green laser-treated eyes .\
METHODS	This is a prospective , randomized , fellow-eye controlled clinical trial conducted on 60 eyes of 30 patients ( mean age 52.3 7.8 years ; 57 % male ) with early - to high-risk proliferative diabetic retinopathy type II diabetes who received standard red or green laser treatment .\
METHODS	Scanning laser polarimetry ( GDx ) was performed to evaluate RNFL thickness at baseline and at week 6 .\
RESULTS	Only 22 patients ( 44 eyes ) could perform reliable GDx tests .\
RESULTS	At week 6 after PRP , the RNFL thickness increased by an average of 3.35 9.18 m ( p = 0.02 ) and 2.08 4.75 m ( p = 0.04 ) in the red and green laser groups , respectively .\
RESULTS	There was no significant correlation between changes in RNFL thickness and the number of laser burns , age , HbA1c or blood pressure .\
RESULTS	The difference in the change of the RNFL thickness between the red and green laser groups was not significant ( p = 0.8 ) .\
CONCLUSIONS	Though RNFL thickness was increased significantly 6 weeks after PRP with red and green laser in comparison to baseline , there was no significant difference in RNFL thickness between red and green laser groups .\
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###16871932\
BACKGROUND	Postoperative scarring in the frontal recess is the most common cause of iatrogenic frontal sinusitis .\
BACKGROUND	Topical mitomycin-C ( MMC ) is an antifibroblastic agent that has been shown to reduce clinical scarring .\
BACKGROUND	This is a preliminary report of a double-blind , randomized , placebo-controlled trial using MMC to determine its effectiveness in reducing frontal recess stenosis after frontal sinusotomy .\
METHODS	All patients with chronic rhinosinusitis undergoing primary or revision bilateral image-guided endoscopic sinus surgery were enrolled .\
METHODS	Patients requiring frontal sinus stents and those with allergic fungal sinusitis were excluded .\
METHODS	After completion of the frontal sinusotomy , dimensions of the frontal recess were measured using curved Frazer suction diameters .\
METHODS	A neuropattie soaked in 0.5 mg/mL of MMC was then placed into one frontal recess for 4 minutes in a randomized manner .\
METHODS	A saline control was used for the other side .\
METHODS	The primary surgeon was blinded to the medicated side intraoperatively and throughout the follow-up period .\
METHODS	Measurements of the frontal recess were repeated at 1 , 3 , and 6 months .\
RESULTS	There was no difference in the degree of frontal recess stenosis between the MMC and control sides at 1 , 3 , and 6 months postoperatively for both primary and revision cases .\
CONCLUSIONS	One-time intraoperative topical MMC is not effective in reducing postoperative frontal recess stenosis in both primary and revision cases .\
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###21454449\
OBJECTIVE	To assess whether screening for prostate cancer reduces prostate cancer specific mortality .\
METHODS	Population based randomised controlled trial .\
METHODS	Department of Urology , Norrkping , and the South-East Region Prostate Cancer Register .\
METHODS	All men aged 50-69 in the city of Norrkping , Sweden , identified in 1987 in the National Population Register ( n = 9026 ) .\
METHODS	From the study population , 1494 men were randomly allocated to be screened by including every sixth man from a list of dates of birth .\
METHODS	These men were invited to be screened every third year from 1987 to 1996 .\
METHODS	On the first two occasions screening was done by digital rectal examination only .\
METHODS	From 1993 , this was combined with prostate specific antigen testing , with 4 g/L as cut off .\
METHODS	On the fourth occasion ( 1996 ) , only men aged 69 or under at the time of the investigation were invited .\
METHODS	Data on tumour stage , grade , and treatment from the South East Region Prostate Cancer Register .\
METHODS	Prostate cancer specific mortality up to 31 December 2008 .\
RESULTS	In the four screenings from 1987 to 1996 attendance was 1161/1492 ( 78 % ) , 957/1363 ( 70 % ) , 895/1210 ( 74 % ) , and 446/606 ( 74 % ) , respectively .\
RESULTS	There were 85 cases ( 5.7 % ) of prostate cancer diagnosed in the screened group and 292 ( 3.9 % ) in the control group .\
RESULTS	The risk ratio for death from prostate cancer in the screening group was 1.16 ( 95 % confidence interval 0.78 to 1.73 ) .\
RESULTS	In a Cox proportional hazard analysis comparing prostate cancer specific survival in the control group with that in the screened group , the hazard ratio for death from prostate cancer was 1.23 ( 0.94 to 1.62 ; P = 0.13 ) .\
RESULTS	After adjustment for age at start of the study , the hazard ratio was 1.58 ( 1.06 to 2.36 ; P = 0.024 ) .\
CONCLUSIONS	After 20 years of follow-up the rate of death from prostate cancer did not differ significantly between men in the screening group and those in the control group .\
CONCLUSIONS	Trial registration Current Controlled Trials , ISRCTN06342431 .\
\
###23971520\
OBJECTIVE	To estimate the cost to the workplace of implementing initiatives to reduce work-family conflict .\
METHODS	Prospective cost analysis conducted alongside a group-randomized multisite controlled experimental study , using a microcosting approach .\
METHODS	An information technology firm .\
METHODS	Employees ( n = 1004 ) and managers ( n = 141 ) randomized to the intervention arm .\
METHODS	STAR ( Start .\
METHODS	Transform .\
METHODS	Achieve .\
METHODS	Results . )\
METHODS	to enhance employees ' control over their work time , increase supervisor support for employees to manage work and family responsibilities , and reorient the culture toward results .\
METHODS	A taxonomy of activities related to customization , start-up , and implementation was developed .\
METHODS	Resource use and unit costs were estimated for each activity , excluding research-related activities .\
METHODS	Economic costing approach ( accounting and opportunity costs ) .\
METHODS	Sensitivity analyses on intervention costs .\
RESULTS	The total cost of STAR was $ 709,654 , of which $ 389,717 was labor costs and $ 319,937 nonlabor costs ( including $ 313,877 for intervention contract ) .\
RESULTS	The cost per employee participation in the intervention was $ 340 ( 95 % confidence interval : $ 330 - $ 351 ) ; $ 597 ( $ 561 - $ 634 ) for managers and $ 300 ( $ 292 - $ 308 ) for other employees ( 2011 prices ) .\
CONCLUSIONS	A detailed activity costing approach allows for more accurate cost estimates and identifies key drivers of cost .\
CONCLUSIONS	The key cost driver was employees ' time spent on receiving the intervention .\
CONCLUSIONS	Ignoring this cost , which is usual in studies that cost workplace interventions , would seriously underestimate the cost of a workplace initiative .\
\
###23144441\
BACKGROUND	Bacterial contamination of intravascular devices has been associated with increased morbidity and mortality in various hospital settings , including the perioperative environment .\
BACKGROUND	Catheter hub disinfection has been shown in an ex vivo model to attenuate intraoperative injection of bacterial organisms originating from the anesthesia provider 's hands , providing the impetus for improvement in intraoperative disinfection techniques and compliance .\
BACKGROUND	In the current study , we investigated the clinical effectiveness of a new , passive catheter care station in reducing the incidence of bacterial contamination of open lumen patient IV stopcock sets .\
BACKGROUND	The secondary aim was to evaluate the impact of this novel intervention on the combined incidence of 30-day postoperative infections and IV catheter-associated phlebitis .\
METHODS	Five hundred ninety-four operating room environments were randomized by a computer-generated list to receive either a novel catheter care bundle ( HubScrub and DOCit ) or standard caps in conjunction with a sterile , conventional open lumen 3-way stopcock set ( 24 inch with 3-gang 4-way and T-Connector ) .\
METHODS	Patients underwent general anesthesia according to usual practice and were followed prospectively for 30 postoperative days to identify the development of health care-associated infections ( HCAIs ) and/or phlebitis .\
METHODS	The primary outcome was intraoperative bacterial contamination of the primary stopcock set used by the anesthesia provider ( s ) .\
METHODS	The secondary outcome was the combined incidence of 30-day postoperative infections and phlebitis .\
RESULTS	Five hundred seventy-two operating rooms were included in the final analysis .\
RESULTS	Study groups were comparable with no significant differences in patient , provider , anesthetic , or procedural characteristics .\
RESULTS	The catheter care station reduced the incidence of primary stopcock lumen contamination compared with standard caps ( odds ratio [ OR ] 0.79 , 95 % confidence interval [ CI ] 0.63-0 .98 , P = 0.034 ) and was associated with a reduction in the combined incidence of HCAIs and IV catheter-associated phlebitis with and without adjustment for patient and procedural covariates ( OR ( adjusted ) 0.589 , 95 % CI 0.353-0 .984 , P = 0.040 ) .\
RESULTS	The risk-adjusted number needed to treat to eliminate 1 case of lumen contamination was 9 ( 95 % CI 3.4-13 .5 ) patients , whereas the risk-adjusted number needed to treat to eliminate 1 case of HCAI/catheter-associated phlebitis was 17 ( 95 % CI 11.8-17 .9 ) patients .\
CONCLUSIONS	Intraoperative use of a passive catheter care station significantly reduced open lumen bacterial contamination and the combined incidence of 30-day postoperative infections and phlebitis .\
\
###24274128\
BACKGROUND	To evaluate the effectiveness of a capacity-building intervention administered through a primary health care ( PHC ) system on community disaster preparedness in Iran .\
METHODS	A controlled community intervention trial with pre - and postassessments was conducted in 2011 in 3 provinces of Iran .\
METHODS	In each province , 2 areas were chosen and randomly selected as an intervention or control group .\
METHODS	A total of 9200 households were in the intervention area and 10 010 were in the control area .\
METHODS	In each study group in each province 250 households were sampled for pre - and postassessment surveys .\
METHODS	Community health volunteers led by PHC staff administered an educational intervention covering elements of hazard awareness and preparedness , with a focus on earthquakes and floods .\
METHODS	Relative changes for awareness and readiness scores were assessed to demonstrate changes in outcome variables from pre - to postassessments in intervention and control groups .\
METHODS	An effectiveness test of significance was based on interaction between time and area .\
RESULTS	Households in intervention communities exhibited improved disaster awareness and readiness with respect to all outcome measures .\
RESULTS	Relative changes in awareness in intervention and control areas were 2.94 and -0.08 , respectively ( P < .001 ) .\
RESULTS	Relative changes for readiness scores were 5.52 in intervention areas and 0.56 in control areas ( P < .001 ) .\
RESULTS	Relative changes for awareness and readiness were significantly correlated with a community 's baseline risk perception and previous experience with natural disasters ( P < .001 ) .\
CONCLUSIONS	An educational intervention administered through the PHC system effectively improved disaster awareness and readiness at a community level .\
CONCLUSIONS	For sustainability , community disaster reduction programs must be integrated into routine public health service delivery .\
\
###21474905\
OBJECTIVE	To examine duration of efficacy of lisdexamfetamine dimesylate ( LDX ) in adults with attention-deficit/hyperactivity disorder ( ADHD ) by effect size in performance and symptom improvement in a simulated adult workplace environment ( AWE ) .\
METHODS	Adults ( aged 18-55 years ) with ADHD enrolled in the AWE study of LDX with open-label dose-optimization and randomized , placebo-controlled , double-blind , 2-way crossover phases .\
METHODS	Efficacy measures included the Permanent Product Measure of Performance ( PERMP ) - Attempted ( - A ) and PERMP-Correct ( - C ) scores assessed throughout the day and the ADHD Rating Scale IV ( ADHD-RS-IV ) with adult prompts .\
METHODS	Model-based least-squares ( LS ) mean effect size was assessed for PERMP and post-hoc ADHD-RS-IV with adult prompts .\
METHODS	Remission was defined as an ADHD-RS-IV total scores 18 .\
METHODS	Safety assessments included treatment-emergent adverse events ( TEAEs ) and vital signs .\
RESULTS	Least-squares mean ( standard error [ SE ] ) effect sizes were 0.9 ( 0.17 ) for PERMP-A and 0.8 ( 0.16 ) for PERMP-C for all postdose sessions .\
RESULTS	For PERMP-A , postdose LS mean ( SE ) effect sizes were 0.5 ( 0.15 ) , 0.8 ( 0.16 ) , 0.7 ( 0.16 ) , 0.7 ( 0.16 ) , 0.7 ( 0.16 ) , and 0.6 ( 0.16 ) at 2 , 4 , 8 , 10 , 12 , and 14 hours , respectively .\
RESULTS	Medium-to-large effect sizes ( 0.5-0 .8 ) were generally maintained from 2 to 14 hours for all PERMP assessments .\
RESULTS	Overall LS mean ( SE ) ADHD-RS-IV total and subscale effect sizes were -1.2 ( 0.19 ) , -1.2 ( 0.19 ) , and -1.0 ( 0.17 ) , respectively .\
RESULTS	Remission was achieved in 67.6 % of participants receiving LDX .\
RESULTS	Treatment-emergent adverse events ( 5 % with LDX ) during the 4-week dose-optimization phase were decreased appetite , dry mouth , headache , insomnia , upper respiratory tract infection , irritability , nausea , anxiety , and feeling jittery .\
RESULTS	During the crossover week on LDX , there were no TEAEs 5 % .\
CONCLUSIONS	In adults studied in the AWE , medium-to-large model-based effect sizes were maintained from 2 to 14 hours postdose , on a performance-based measure of productivity , suggesting participants experienced improvement in sustained attention throughout the day and into the evening hours .\
CONCLUSIONS	Lisdexamfetamine dimesylate demonstrated a safety profile consistent with long-acting stimulants .\
\
###19564812\
BACKGROUND	Most cases of acute otitis media ( AOM ) follow an upper respiratory infection due to viruses , including influenza viruses .\
BACKGROUND	As effective and safe influenza vaccines are available , their use has been considered among the possible measures of AOM prophylaxis .\
OBJECTIVE	To evaluate the efficacy of an inactivated virosomal-adjuvanted influenza vaccine in preventing AOM in children with a history of noncomplicated recurrent AOM ( rAOM ) or rAOM complicated by spontaneous perforation .\
METHODS	In this prospective , randomized , single-blinded , placebo-controlled study , 180 children aged 1 to 5 years with a history of rAOM and previously unvaccinated against influenza were randomized to receive the inactivated virosomal-adjuvanted subunit influenza vaccine ( n = 90 ) or no treatment ( n = 90 ) , and AOM-related morbidity was monitored every 4 to 6 weeks for 6 months .\
RESULTS	The number of children experiencing at least 1 AOM episode was significantly smaller in the vaccinated group ( P < 0.001 ) , as was the mean number of AOM episodes ( P = 0.03 ) , the mean number of AOM episodes without perforation ( P < 0.001 ) , and the mean number of antibiotic courses ( P < 0.001 ) ; the mean duration of bilateral OME was significantly shorter ( P = 0.03 ) .\
RESULTS	The only factor that seemed to be associated with the significantly greater efficacy of influenza vaccine in preventing AOM was the absence of a history of recurrent perforation ( crude odds ratio , P = 0.01 ; adjusted odds ratio , P = 0.006 ) .\
CONCLUSIONS	The intramuscular administration of injectable trivalent inactivated virosomal-adjuvanted influenza vaccine in children with a history of rAOM significantly reduces AOM-related morbidity .\
CONCLUSIONS	However , the efficacy of this preventive measure seems to be reduced in children with rAOM associated with repeated tympanic membrane perforation .\
\
###10698808\
OBJECTIVE	The atypical subtype of depression appears to be both well validated and common .\
OBJECTIVE	Although monoamine oxidase inhibitors are effective in treating atypical depression , their side effects and prescription-associated dietary restrictions reduce their suitability as a first-line treatment .\
OBJECTIVE	The objective of this study was to estimate the efficacy of the selective serotonin reuptake inhibitor ( SSRI ) fluoxetine in the treatment of major depression with atypical features .\
METHODS	One hundred fifty-four subjects with DSM-IV major depression who met the Columbia criteria for atypical depression were randomly assigned to receive fluoxetine , imipramine , or placebo for a 10-week clinical trial .\
METHODS	Imipramine was included because its known efficacy for treatment of atypical depression helped to calibrate the appropriateness of the study group .\
RESULTS	In both intention-to-treat and completer groups , the effectiveness of both fluoxetine and imipramine was significantly better than that of placebo .\
RESULTS	The two medications did not differ from each other in effectiveness .\
RESULTS	Significantly more patients dropped out of treatment with imipramine than with fluoxetine .\
RESULTS	Before treatment , patients on average rated themselves as very impaired on psychological dimensions of general health and moderately impaired on physical dimensions , compared with population norms .\
RESULTS	The self-ratings of patients who responded to treatment essentially normalized on these measures .\
CONCLUSIONS	Despite earlier data that SSRIs might be the treatment of choice , fluoxetine appeared to be no better than imipramine in the treatment of atypical depression , although fluoxetine was better tolerated than imipramine .\
\
###24050787\
OBJECTIVE	To assess impacts of the nationwide Norwegian School Fruit Scheme ( NSFS ) using nationally representative data .\
METHODS	The NSFS is organized such that primary-school children ( grades 1-7 ) are randomly assigned to one of three school fruit arrangements : ( i ) the child receives one free fruit or vegetable per day ; ( ii ) the child is given the option to subscribe to one fruit or vegetable per day at a subsidized price ; and ( iii ) the child attends a school that has no school fruit arrangement .\
METHODS	Data from an Internet survey are used to compare child and parental fruit and vegetable intakes across the three NSFS groups focusing mainly on groups ( i ) and ( iii ) .\
METHODS	The analysis was conducted using multivariate regression techniques .\
METHODS	Parents of primary-school children ( n 1423 ) who report on behalf of themselves and their children .\
RESULTS	Children who receive free school fruit eat on average 036 more fruit portions daily - or 250 % more fruits - than children who attend schools with no fruit arrangement ( P < 0001 ) .\
RESULTS	Moreover , parents of children who receive free school fruit eat on average 019 more fruit portions daily - or 125 % more fruits - than parents of children who attend schools with no fruit arrangement ( P = 0040 ) .\
RESULTS	No significant associations were found between the NSFS and the vegetable intakes of children and their parents .\
CONCLUSIONS	The study shows , using nationally representative data , that free school fruit is associated with increased child fruit intake and that it may also affect parental fruit intake .\
\
###16482073\
OBJECTIVE	To compare the effects of alpha-linolenic acid ( ALA , C18 :3 n-3 ) to those of eicosapentaenoic acid ( EPA , C20 :5 n-3 ) plus docosahexaenoic acid ( DHA , C22 :6 n-3 ) on cardiovascular risk markers in healthy elderly subjects .\
METHODS	A randomized double-blind nutritional intervention study .\
METHODS	Department of Human Biology , Maastricht University , the Netherlands .\
METHODS	Thirty-seven mildly hypercholesterolemic subjects , 14 men and 23 women aged between 60 and 78 years .\
METHODS	During a run-in period of 3 weeks , subjects consumed an oleic acid-rich diet .\
METHODS	The following 6 weeks , 10 subjects remained on the control diet , 13 subjects consumed an ALA-rich diet ( 6.8 g/day ) and 14 subjects an EPA/DHA-rich diet ( 1.05 g EPA/day + 0.55 g DHA/day ) .\
RESULTS	Both n-3 fatty acid diets did not change concentrations of total-cholesterol , LDL-cholesterol , HDL-cholesterol , triacylglycerol and apoA-1 when compared with the oleic acid-rich diet .\
RESULTS	However , after the EPA/DHA-rich diet , LDL-cholesterol increased by 0.39 mmol/l ( P = 0.0323 , 95 % CI ( 0.030 , 0.780 mmol/l ) ) when compared with the ALA-rich diet .\
RESULTS	Intake of EPA/DHA also increased apoB concentrations by 14 mg/dl ( P = 0.0031 , 95 % CI ( 4 , 23 mg/dl ) ) and 12 mg/dl ( P = 0.005 , 95 % CI ( 3 , 21 mg/dl ) ) versus the oleic acid and ALA-rich diet , respectively .\
RESULTS	Except for an EPA/DHA-induced increase in tissue factor pathway inhibitor ( TFPI ) of 14.6 % ( P = 0.0184 versus ALA diet , 95 % CI ( 1.5 , 18.3 % ) ) , changes in markers of hemostasis and endothelial integrity did not reach statistical significance following consumption of the two n-3 fatty acid diets .\
CONCLUSIONS	In healthy elderly subjects , ALA might affect concentrations of LDL-cholesterol and apoB more favorably than EPA/DHA , whereas EPA/DHA seems to affect TFPI more beneficially .\
\
###21900786\
OBJECTIVE	A good bowel preparation is essential for optimal visualization of the large intestine .\
OBJECTIVE	Several preparations with a difference in composition and volume are available .\
OBJECTIVE	We compared five methods for bowel cleansing quality and patients ' acceptability .\
METHODS	Adult ambulatory outpatients scheduled for elective colonoscopy were randomized to receive 4-l polyethylene glycol ( PEG ) solution ( Klean-prep ) , 2-l PEG solution + ascorbic acid ( Moviprep ) , or a sodium phosphate ( NaP ) solution , Phosphoral .\
METHODS	Patients with the PEG solutions were also randomized to receive simethicone ( Aeropax ) , to investigate whether this improves the bowel cleansing efficacy .\
METHODS	Before colonoscopy patients completed a questionnaire about the acceptability and tolerability of the preparation .\
METHODS	Endoscopists blinded to the type of preparation gave a bowel cleansing score .\
RESULTS	Data were available for 461 patients .\
RESULTS	2-l PEG + ascorbic acid was noninferior to 4-l PEG in bowel cleansing quality of rectosigmoid and colon .\
RESULTS	NaP was noninferior to 4-l PEG in bowel cleansing quality of rectosigmoid but inferior for the whole colon .\
RESULTS	Compliance was significantly less in the group with 4-l PEG compared with the 2-l PEG and NaP group .\
RESULTS	No difference was found for abdominal cramps .\
RESULTS	Taste was significantly better in the 2-l PEG group .\
RESULTS	Simethicone did not improve the bowel cleansing quality .\
CONCLUSIONS	2-l PEG + ascorbic acid was noninferior to the 4-l PEG solution in bowel cleansing quality and was better in taste and compliance .\
CONCLUSIONS	NaP was inferior to 4-l PEG in bowel cleansing quality .\
CONCLUSIONS	Addition of simethicone gave no improvement .\
\
###9663731\
BACKGROUND	Stool softening is a physician 's first step in the management of chronic constipation .\
OBJECTIVE	To compare stool softening ( stool water content ) and laxative efficacy of psyllium hydrophilic mucilloid vs. docusate sodium .\
METHODS	The multi-site , randomized , double-blind , parallel-design study of 170 subjects with chronic idiopathic constipation involved a 2-week baseline ( placebo ) phase followed by 2 weeks of treatment .\
METHODS	The treatment phase compared psyllium ( 5.1 g b.d. ) plus docusate placebo to docusate sodium ( 100 mg b.d. ) plus psyllium placebo .\
METHODS	Stools were collected and assessed .\
RESULTS	Compared to baseline , psyllium increased stool water content vs. docusate ( psyllium 2.33 % vs. docusate 0.01 % , P = 0.007 ) .\
RESULTS	Psyllium also increased stool water weight ( psyllium 84.0 g/BM ; docusate 71.4 g/BM ; P = 0.04 ) , total stool output ( psyllium 359.9 g/week : docusate 271.9 g/week ; P = 0.005 ) , and O'Brien rank-type score combining objective measures of constipation ( psyllium 475.1 ; docusate 403.9 ; P = 0.002 ) .\
RESULTS	Bowel movement ( BM ) frequency was significantly greater for psyllium ( 3.5 BM/week ) vs. docusate ( 2.9 BM/week ) in treatment week 2 ( P = 0.02 ) , with no significant difference ( P > 0.05 ) between treatment groups in treatment week 1 ( 3.3 vs. 3.1 BM/week ) .\
CONCLUSIONS	Psyllium is superior to docusate sodium for softening stools by increasing stool water content , and has greater overall laxative efficacy in subjects with chronic idiopathic constipation .\
\
###15701209\
OBJECTIVE	To review outcomes of diabetic patients treated with losartan in two recent randomized , double-blind , clinical trials and compare outcomes to similar studies in diabetics .\
METHODS	The Reduction in ENdpoints with the Angiotensin II Antagonist Losartan ( RENAAL ) study recruited 1513 patients with type 2 diabetes and nephropathy .\
METHODS	The Losartan Intervention For Endpoint reduction ( LIFE ) study recruited 9193 hypertensive patients with left ventricular hypertrophy ( LVH ) including 1195 with diabetes mellitus .\
METHODS	The maximum losartan dose in both studies was 100 mg daily .\
METHODS	All study patients could receive additional antihypertensive medications , excluding angiotensin converting enzyme inhibitors ( ACEIs ) and other angiotensin receptor blockers ( ARBs ) , if blood pressures ( BP ) < 140/90 mmHg were not achieved .\
METHODS	In RENAAL , the control group received placebo whereas in LIFE , controls received atenolol .\
METHODS	BP reductions were comparable in the treatment and control groups of both studies .\
METHODS	In RENAAL , the primary outcome was the composite of doubling of serum creatinine , end-stage renal disease , or death .\
METHODS	In LIFE , the primary composite outcome was cardiovascular death and non-fatal myocardial infarction or stroke .\
RESULTS	In RENAAL , losartan reduced the primary composite end-point 16 % ( p = 0.02 ) and the incidence of end-stage renal disease ( ESRD ) 28 % ( p = 0.002 ) .\
RESULTS	In LIFE , the primary composite endpoint among diabetics was reduced 24 % ( p = 0.03 ) , cardiovascular mortality was reduced 37 % ( p = 0.03 ) and total mortality was reduced 39 % ( p = 0.002 ) .\
CONCLUSIONS	In diabetic patients with nephropathy , losartan reduces progression to endstage renal disease .\
CONCLUSIONS	In hypertensive diabetic patients with LVH , losartan reduces cardiovascular morbidity and mortality and total mortality .\
CONCLUSIONS	Angiotensin receptor blockade with losartan appears to confer benefits beyond BP reduction in diabetic patients at high-risk for cardiovascular and renal events .\
\
###12137819\
OBJECTIVE	The high recurrence rate is still the major complication of endoscopic treatment of urethral stricture disease .\
OBJECTIVE	To compare the outcome of patients who underwent direct vision internal urethrotomy ( DVIU ) and then followed a protocol that randomized them to either our urethral dilation protocol or consecutive DVIUs for the treatment of their urethral stricture .\
METHODS	A total of 37 patients , who had undergone at least two DVIUs to treat their recurrent urethral strictures , were enrolled in this study .\
METHODS	They were randomized into two groups .\
METHODS	The etiology and location of the strictures were similar , and their length ranged from 0.5 to 2 cm in each group .\
METHODS	In group 1 ( n = 18 ) , the patients were observed by regular visits and uroflowmetry profiles after the initial DVIU and consecutive DVIUs were considered when the stricture recurred .\
METHODS	In group 2 ( n = 19 ) , patients received urethral dilations with Benique dilatators ( maximal 21F ) under intraurethral anesthesia , beginning 10 days after the initial internal urethrotomy , according to the following protocol : weekly for the first month , once after 3 and after 6 months , and then once each year .\
RESULTS	After a median follow-up of 30 months , the urethral stricture recurred within 12 months in 55.6 % ( n = 10 ) of group 1 , and consecutive DVIUs were indicated .\
RESULTS	During the same follow-up period , recurrence was observed in 2 patients ( 10.5 % ) , 9 months and 2 years after randomization , in group 2 ( P < 0.05 ) .\
RESULTS	The mean maximal urinary flow rate in groups 1 and 2 at last follow-up was 7.8 + / - 3.7 and 21.0 + / - 8.7 mL/s , respectively ( P < 0.01 ) .\
CONCLUSIONS	We suggest a regular , simple urethral dilation protocol for patients with recurrent bulbomembranous urethral stricture shorter than 2 cm , because this significantly allays the stricture recurrence rate , possibly eliminates the need for consecutive DVIU , and reduces morbidity .\
\
###8632572\
OBJECTIVE	To assess the pharmacodynamic equivalence of the new 10.8 mg .\
OBJECTIVE	goserelin depot with the current 3.6 mg .\
OBJECTIVE	depot 3 studies were performed in patients with advanced prostate cancer .\
METHODS	In 2 comparative studies 160 patients were randomized for dosing every 12 weeks using the 10.8 mg .\
METHODS	depot or every 4 weeks using the 3.6 mg .\
METHODS	depot .\
METHODS	In the noncomparative study 35 patients received the 10.8 mg .\
METHODS	depot .\
METHODS	Blood sampling for serum testosterone and evaluation of toxicity was done during the 48-week study period .\
RESULTS	Serum testosterone profiles of the 10.8 and 3.6 mg .\
RESULTS	goserlin depots were similar with testosterone levels decreasing into the castrate range by day 21 after depot administration .\
RESULTS	The safety profile of 10.8 mg .\
RESULTS	goserelin is comparable to that of the current monthly depot with the main side effects related to androgen deprivation .\
CONCLUSIONS	The new long acting depot was pharmacologically equivalent , and well tolerated locally and systemically , and will offer added convenience to patients and health care personnel .\
\
###16858017\
OBJECTIVE	haptic cues from fingertip light touch ( LT ) with a stationary surface reduce postural sway even at non-mechanically supportive force levels .\
OBJECTIVE	Aim of this study was to determine the effects of LT on postural sway in older compared with younger persons .\
METHODS	twenty young ( age 20-29 , mean 23.9 + 2.5 ) and 20 older participants ( age 65-83 , mean 74.3 + 6.4 ) .\
METHODS	subjects stood in the semi-tandem position on a firm surface , and their postural sway was quantified using a force platform .\
METHODS	Experimental trials , randomised across subjects , included two sight conditions ( vision and no vision ) and three contact conditions ( no touch , NT ; light touch , LT ; and force touch , FT ) .\
METHODS	The measured parameters were the length and the area of centre of pressure sway ( COP-L and COP-A ) and the mean velocity of COP displacements in the anterior-posterior ( COP-AP ) and medial-lateral ( COP-ML ) direction .\
RESULTS	for all variables , the analysis showed significant differences between contact conditions , sight conditions and age .\
RESULTS	Contact-age interaction was significant between NT and LT conditions , with older participants showing greater decrease in postural sway than younger participants , but not between FT and LT conditions .\
CONCLUSIONS	results indicate that the effectiveness of LT in reducing postural sway may be greater in older than in younger persons , perhaps because in older persons haptic cues from upper extremity might counterbalance sub-clinical sensory loss in the lower extremities .\
CONCLUSIONS	This finding supports the hypothesis that older people may sometimes use a walking aid as an informative device and suggests that during balance training external aids should not be used .\
\
###17461530\
OBJECTIVE	Several analgesic techniques are available for pain management after a major operation .\
METHODS	From December 2005 to February 2006 , a prospective , double-blind study was performed involving 90 patients who had undergone a total knee arthroplasty .\
METHODS	Patients were randomly divided into three equal groups ( n = 30 ) .\
METHODS	Demographic data , including age , height , weight , knee score , visual analogue scale ( VAS ) , and range of flexion were evaluated preoperatively .\
METHODS	Before wound closure , patients were given intra-synovial injections of the following solutions : patients in group I received 40mL of 300mg ropivacaine with 1:200,000 epinephrine and 5mg morphine ; patients in Group II received 40mL of 300mg ropivacaine with epinephrine ; and patients in Group III received 50mL normal saline as a control .\
METHODS	All patients received an epidural patient-controlled analgesia ( PCA ) for 24 postoperative hours .\
METHODS	Analgesic efficacy was evaluated using the VAS at intervals of 2 , 4 , 6 , 12 , 24 , 32 , 40 , and 48 hours postoperatively .\
METHODS	During this period , the side effects , the dosage of rescue analgesia required , and the range of knee flexion were recorded for each group .\
RESULTS	There were no significant differences among the three groups with regards to the VAS and the required dose of rescue analgesia ( p > 0.05 ) .\
RESULTS	None of the groups demonstrated significant differences in the range of knee flexion and the incidence of postoperative nausea and emesis ( p > 0.05 ) .\
CONCLUSIONS	Therefore , we found that ropivacaine , alone or with morphine , injected into the synovial tissue , along with an epidural PCA has no additional benefits in pain control after a total knee arthroplasty .\
\
###23797459\
BACKGROUND	No treatment for auditory neglect and no randomized controlled trial evaluating smooth pursuit eye movement therapy ( SPT ) for multimodal neglect are available .\
OBJECTIVE	To compare the effects of SPT and visual scanning therapy ( VST ) on auditory and visual neglect in chronic stroke patients with neglect .\
METHODS	A randomized , prospective trial was conducted .\
METHODS	Fifty patients with left auditory and visual neglect were randomly assigned .\
METHODS	Twenty-four patients completed SPT therapy and 21 patients VST .\
METHODS	Five patients ( 4 VST , 1 SPT ) were lost .\
METHODS	Each group received 1-hour sessions of neglect therapy for 5 consecutive days totaling 5 hours .\
METHODS	Outcome measures in visual neglect ( digit cancellation , visuoperceptual - and motor line bisection , paragraph reading ) and auditory neglect ( auditory midline ) were assessed twice before therapy , thereafter , and at 2-week follow-up .\
METHODS	The SPT group practiced smooth pursuit eye movements while tracking stimuli moving leftward .\
METHODS	The VST group systematically scanned the same but static stimuli .\
METHODS	Both groups were divided into subgroups , and effects were separately investigated for mild and severe neglect .\
RESULTS	Both groups did not differ before therapy in clinical/demographic variables or neglect severity ( auditory/visual ) .\
RESULTS	After treatment , the SPT group showed significant and lasting improvements in all visual measures and normal performance in the auditory midline .\
RESULTS	Neither visual nor auditory neglect impairments changed significantly after VST .\
RESULTS	Moreover , the treatment effect sizes ( Cohens d ) were considerably higher for visual and auditory neglect after SPT versus VST , both for mild and severe neglect .\
CONCLUSIONS	Repetitive contralesional , smooth pursuit training induces superior , multimodal therapeutic effects in mild and severe neglect .\
\
###17202007\
BACKGROUND	The aim of this study was to compare the efficacy of topical levobupivacaine drops 0.75 % vs. lidocaine drops 4 % in cataract surgery .\
METHODS	We examined 203 patients undergoing cataract surgery by phacoemulsification .\
METHODS	They were randomized into two groups : one received four drops of lidocaine 4 % and the other received four drops of levobupivacaine 0.75 % .\
METHODS	The onset and offset times of sensory block were evaluated .\
METHODS	Application , intraoperative and postoperative subjective pain was quantified by the patients using a verbal pain score .\
METHODS	Complications , rates of supplemental anaesthesia , and the satisfaction of surgeon and patients were also recorded .\
RESULTS	The mean sensory onset and offset times were significantly higher for the levobupivacaine group ( P < 0.01 ) .\
RESULTS	Pain score was lower in the levobupivacaine group than in the lidocaine one and the difference was statistically significant at all stages ( P < 0.01 ) .\
RESULTS	The mean satisfaction scores of patients and surgeon were also statistically higher for levobupivacaine ( P < 0.01 ) .\
RESULTS	No significant differences for complications and rates of supplemental anaesthesia were found .\
CONCLUSIONS	Topical levobupivacaine 0.75 % shows the same efficacy and safety as lidocaine 4 % in cataract surgery by phacoemulsification .\
CONCLUSIONS	There was an adequate block with a good level of satisfaction of surgeon and patients .\
CONCLUSIONS	Levobupivacaine 0.75 % offers a new and acceptable choice for topical anaesthesia in cataract surgery .\
\
###25104109\
BACKGROUND	In the AFFIRM trial of patients with metastatic castration-resistant prostate cancer after progression with docetaxel treatment , enzalutamide significantly increased overall survival compared with placebo .\
BACKGROUND	Here we present the prospectively defined analyses of some secondary endpoints , including occurrence of skeletal-related events , measures of pain control , and patient-reported health-related quality of life ( HRQoL ) .\
METHODS	In this phase 3 , double-blind trial , patients were randomly assigned ( 2:1 ) to receive enzalutamide 160 mg/day or placebo orally , stratified by ECOG baseline performance status ( 0 or 1 vs 2 ) and mean pain score ( Brief Pain Inventory-Short Form [ BPI-SF ] question 3 worst pain , score 3 vs 4 ) .\
METHODS	Secondary endpoints were time to first skeletal-related event ( defined as radiation therapy or surgery to bone ) ; change from baseline to week 13 in pain severity and interference ; pain palliation and progression at week 13 ; time to pain progression ; overall improvement in HRQoL ; improvements in HRQoL domains ; and time to HRQoL deterioration .\
METHODS	Analysis was done on the intention-to-treat population for each endpoint .\
METHODS	AFFIRM is registered with ClinicalTrials.gov , number NCT00974311 .\
RESULTS	Median time to first skeletal-related event in the enzalutamide ( n = 800 ) and placebo ( n = 399 ) groups was 167 months ( 95 % CI 146 to 191 ) and 133 months ( 95 % CI 99 to not yet reached ) , respectively ( hazard ratio [ HR ] 069 [ 95 % CI 057-084 ] ; p = 00001 ) .\
RESULTS	Pain progression at week 13 occurred in 174 ( 28 % ) of 625 evaluable patients in the enzalutamide group versus 101 ( 39 % ) of 259 patients in the placebo group ( difference -112 % , 95 % CI -181 to -43 ; p = 00018 ) .\
RESULTS	Median time to pain progression was not yet reached in the enzalutamide group ( 95 % CI not yet reached to not yet reached ) versus 138 ( 138 to not yet reached ) months in the placebo group ( HR 056 [ 95 % CI 041 to 078 ] ; p = 00004 ) .\
RESULTS	Mean treatment effects for pain severity ( mean change from baseline in the enzalutamide group -015 , 95 % CI -028 to -002 , vs placebo 050 , 029 to 070 ; difference -065 , 95 % CI -089 to -041 ; p < 00001 ) and interference ( -001 , -018 to 016 , vs 074 , 047 to 100 ; respectively , difference -074 , 95 % -106 to -043 ; p < 00001 ) were significantly better with enzalutamide than with placebo .\
RESULTS	22 ( 45 % ) of 49 evaluable patients in the enzalutamide group reported pain palliation at week 13 versus one ( 7 % ) of 15 in the placebo group ( difference 382 % , 95 % CI 194-570 ; p = 00079 ) .\
RESULTS	Overall improvement in HRQoL was reported in more patients receiving enzalutamide ( 275 [ 42 % ] of 652 ) than in those receiving placebo ( 36 [ 15 % ] of 248 ; p < 00001 ) .\
RESULTS	Patients in the enzalutamide group had longer median time to HRQoL deterioration than did those in the placebo group ( 90 months , 95 % CI 83-111 , vs 37 months , 95 % CI 30-42 ; HR 045 , 95 % CI 037-055 ; p < 00001 ) in risk of deterioration .\
CONCLUSIONS	Our results show that , in addition to improving overall survival , enzalutamide improves wellbeing and everyday functioning of patients with metastatic castration-resistant prostate cancer .\
BACKGROUND	Astellas Pharma and Medivation .\
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###22323414\
OBJECTIVE	To determine exposure to hyper - and hypoglycemia using blinded continuous glucose monitoring ( CGM ) profiles in youth with type 1 diabetes ( T1D ) with residual - cell function during the first year of insulin treatment .\
METHODS	Blinded , 3-7 day CGM profiles were obtained in 16 short-term T1D patients ( age 8-18 years , T1D duration 6-52 weeks ) who had peak C-peptide levels ranging from 0.46 to 1.96 nmol/L during a mixed-meal tolerance test .\
METHODS	Results in this short-term group were compared with those in 34 patients with well-controlled , longer-term T1D ( duration 5 years ) , matched for age and A1C with the short-term T1D group , and with those in 26 age-matched nondiabetic individuals .\
RESULTS	Despite matching for A1C , and therefore similar mean sensor glucose levels in the two T1D groups , short-term T1D participants had a lower frequency of hypoglycemia ( 0.3 vs. 7.6 % , P < 0.001 ) , a trend toward less hyperglycemia ( 17 vs. 32 % , P = 0.15 ) , and a greater percentage in the target range ( median 77 vs. 60 % , P = 0.02 ) .\
RESULTS	Indeed , the percentage of sensor glucose levels 70 mg/dL in the short-term T1D group ( 0.3 % ) did not differ from those in the nondiabetic group ( 1.7 % , P = 0.73 ) .\
RESULTS	The coefficient of variation of sensor glucose levels ( an index of glucose variability ) was lower in short-term vs. longer-term T1D participants ( 27 vs. 42 % , respectively , P < 0.001 ) .\
CONCLUSIONS	In youth with short-term T1D who retain residual - cell function , there is negligible exposure to hypoglycemia and lower glucose variability than in youth with well-controlled T1D of longer duration .\
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###16279272\
BACKGROUND	Incidence rates for many types of cancer are higher among African American men than in the general population , yet African American men are less likely to participate in cancer screening trials .\
BACKGROUND	This paper describes the outcomes of a randomized trial ( the AAMEN Project ) designed to recruit African American men aged 55-74 years to a prostate , lung and colorectal cancer screening trial .\
METHODS	The recruitment interventions address four types of barriers to clinical trial participation : sociocultural barriers , economic barriers , individual barriers and barriers inherent in study design .\
METHODS	Subjects were randomized to a control group or one of three increasingly intensive intervention arms , which used different combinations of mail , phone and in person church-based recruitment .\
RESULTS	Of the 39,432 African American men residing in the geographically defined study population ( southeastern Michigan and northern Ohio ) , 17,770 men ( 45 % ) could be contacted , and 12,400 ( 31 % of 39,432 ) were found to be eligible to participate .\
RESULTS	No statistically significant differences in age , education or income level were found among participants in the four study arms .\
RESULTS	A significantly greater enrollment yield ( 3.9 % ) was seen in the most intensive , church-based intervention arm , compared to the enrollment yields in the other two intervention arms ( 2.5 and 2.8 % ) or the control group ( 2.9 % ) ( P < 0.01 ) .\
CONCLUSIONS	The intervention that involved the highest rate of face-to-face contact with the study participants produced the highest enrollment yield , but several strategies that were thought could improve yield had no effect .\
CONCLUSIONS	These findings , which are consistent with current literature on population-based recruitment , should facilitate the development of future recruitment efforts involving older African American men .\
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###24730623\
OBJECTIVE	To evaluate the intra-operative and postoperative outcome of paediatric cataract surgery with primary posterior capsulotomy ( PPC ) and anterior vitrectomy using intra-operative preservative-free triamcinolone acetonide .\
METHODS	In this prospective , interventional case-control study , 20 Children who underwent cataract surgery for both eyes were enrolled and their eyes were randomized into two groups .\
METHODS	Group A consists of 20 eyes in which standard phacoaspiration with PPC with intracameral triamcinolone was used , and Group B consists of 20 eyes in which triamcinolone were not used .\
METHODS	Intra-operative complications and postoperative outcome like intraocular pressure ( IOP ) , posterior synechiae , pigment deposits and posterior capsule opacification ( PCO ) were studied .\
RESULTS	In both groups , age range varied between 2-8 years comprising 18 males and two females .\
RESULTS	The mean postoperative IOP did not show any significant variation during 6-month follow-up .\
RESULTS	In study group , all the 20 eyes were quiet at 2 weeks , while there was cellular reaction 1 + in four eyes ( 20 % ) and nil in 16 eyes ( 80 % ) at 2 week in the control group ( p = 0.035 ) .\
RESULTS	Pigment deposits on IOL optic was seen in two eyes ( 10 % ) of the study group while in control group , IOL deposits were present in 14 eyes ( 70 % ) ( p = 0.001 ) .\
RESULTS	Posterior capsule opacification was seen in two eyes ( 10 % ) in control group at 3 months while none occurred in study group .\
CONCLUSIONS	Intra-operative use of preservative-free triamcinolone acetonide led to less anterior chamber inflammation and pigment deposits on IOL optic postoperatively compared to those eyes where it was not used .\
\
###19112513\
BACKGROUND	Highly pathogenic influenza A/H5N1 has caused outbreaks in wild birds and poultry in Asia , Africa and Europe .\
BACKGROUND	It has also infected people , especially children , causing severe illness and death .\
BACKGROUND	Although the virus shows limited ability to transmit between humans , A/H5N1 represents a potential source of the next influenza pandemic .\
BACKGROUND	This study assesses the safety and immunogenicity of aluminium hydroxide adjuvanted ( Al ) and non adjuvanted influenza A/Vietnam/1194 / 2004 NIBRG-14 ( H5N1 ) vaccine in children .\
RESULTS	In a Phase II , open , randomised , multicentre trial 180 children aged 6 months to 17 years received two injections , 21 days apart , of vaccine containing either : 30 microg haemagglutinin ( HA ) with adjuvant ( 30 microg + Al ) or 7.5 microg HA without adjuvant .\
RESULTS	An additional 60 children aged 6-35 months received two `` half dose '' injections ( ie 15 microg + Al or 3.8 microg ) .\
RESULTS	Safety was followed for 21 days after vaccination .\
RESULTS	Antibody responses were assessed 21 days after each injection and cellular immune responses were explored .\
RESULTS	Vaccination appeared well tolerated in all age groups .\
RESULTS	The 30 microg + Al formulation was more immunogenic than 7.5 microg in all age groups : in these two groups 79 % and 46 % had haemagglutinination inhibition antibody titres > or = 32 ( 1/dil ) .\
RESULTS	Among 6-35 month-olds , the full doses were more immunogenic than their half dose equivalents .\
RESULTS	Vaccination induced a predominantly Th2 response against H5 HA .\
CONCLUSIONS	This influenza A ( H5N1 ) vaccine was well tolerated and immunogenic in children and infants , with Al adjuvant providing a clear immunogenic advantage .\
CONCLUSIONS	These results demonstrate that an H5N1 Al-adjuvanted vaccine , previously shown to be immunogenic and safe in adults , can also be used in children , the group most at risk for pandemic influenza .\
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###24131496\
BACKGROUND	Cardiovascular morbidity and mortality is increased in individuals with severe mental illnesses.We set out to establish a multicentre , two arm , parallel cluster randomized controlled trial ( RCT ) of a health promotion intervention ( HPI ) , IMPACT Therapy .\
BACKGROUND	The patient-tailored IMPACT Therapy aims to target one or more health behaviours from a pre-defined list that includes cannabis use ; alcohol use ; other substance use ; cigarette smoking ; exercise ; diet and diabetic control , prioritising those identified as problematic by the patient , taking a motivational interviewing and CBT approach .\
METHODS	Impact therapy will be delivered by care coordinators in the community to the treatment group and will be compared to treatment as usual ( TAU ) .\
METHODS	The main hypothesis is that the addition of IMPACT Therapy ( HPI ) to TAU will be more effective than TAU alone in improving patients ' quality of life as measured by the Short Form-36 , including mental health and physical health subscales on completion of the intervention at 12 months post randomisation .\
METHODS	A subsidiary hypothesis will be that addition of IMPACT Therapy ( HPI ) will be more cost-effective than TAU alone in improving health in people with SMI 12 months from baseline .\
METHODS	The IMPACT therapy patient groups ' improvement in quality of life , as well as its cost effectiveness , is hypothesised to be maintained at 15 months .\
METHODS	Outcomes will be analyzed on an intention-to-treat ( ITT ) basis .\
CONCLUSIONS	The results of the trial will provide information about the effectiveness of the IMPACT therapy programme in supporting community mental health teams to address physical comorbidity in severe mental illness .\
BACKGROUND	ISRCTN58667926 .\
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###16507195\
OBJECTIVE	The GlideScope videolaryngoscope is a newly developed laryngoscope for tracheal intubation recently introduced into clinical anaesthesia .\
OBJECTIVE	In this randomised clinical study , we compared the haemodynamic responses to orotracheal intubation using a GlideScope videolaryngoscope and a fibreoptic bronchoscope .\
METHODS	Fifty-six adult patients , ASA I-II scheduled for elective plastic surgery under general anaesthesia requiring orotracheal intubation were randomly allocated to either the GlideScope videolaryngoscope group or the fibreoptic bronchoscope group .\
METHODS	After a standard intravenous anaesthetic induction , orotracheal intubation was performed .\
METHODS	Noninvasive blood pressure and heart rate were recorded before and after induction , at intubation and for 5 min after intubation at 1 min intervals .\
RESULTS	As compared with the post-induction values the orotracheal intubations using a fibreoptic bronchoscope and a GlideScope videolaryngoscope resulted in the significant increases in blood pressures which did not exceed their baseline values .\
RESULTS	In the two groups , heart rates at intubation and within 2 min after intubation were significantly higher than their baseline values .\
RESULTS	However , there were no significant differences in blood pressures and heart rates at all time points , their maximal values and maximal percent changes during the observation and the times required to reach their maximal values between the two groups .\
CONCLUSIONS	The orotracheal intubations using a fibreoptic bronchoscope and a GlideScope videolaryngoscope produce similar haemodynamic responses .\
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###9389947\
OBJECTIVE	To test the efficacy of treatment with clindamycin of a partner on the recurrence rate of bacterial vaginosis in women within 3 months from diagnosis .\
METHODS	Eligible for the study were sexually active women with one current sexual partner , who were aged 18-45 years , with a clinical diagnosis of bacterial vaginosis and whose partner agreed to be treated .\
METHODS	A double blind , randomised , controlled trial was conducted comparing the effect of treating the partner with either clindamycin capsules or placebo on the reduction of the recurrence rate of bacterial vaginosis .\
METHODS	Women were treated with clindamycin 2 % vaginal cream , administered intravaginally once daily at bedtime for 7 consecutive days .\
METHODS	The partners were randomly allocated to clindamycin hydrochloride capsules , 150 g by mouth four times daily for 7 consecutive days , or a placebo .\
METHODS	A total of 139 couples were randomised -- 69 were treated with clindamycin vaginal cream group and 70 with placebo .\
METHODS	One , 4 , and 12 weeks after the end of treatment the patients and their partners were examined ; vaginal discharges were examined to check for clue cells , vaginal pH was determined , and a KOH test carried out .\
RESULTS	Overall , 131 women out of the 139 who entered the study were cured ( 94.2 % , lower 95 % confidence interval 79.8 , based on Poisson 's approximation ) .\
RESULTS	There was no difference in the cure rate among women whose partner received clindamycin or placebo ( chi ( 2 ) p = not significant ) .\
RESULTS	A total of 55 couples ( 26 in the clindamycin and 29 in the placebo group ) withdrew from the study during the follow up period .\
RESULTS	Of the 69 women whose partner received clindamycin , 22 ( 31.9 % ) reported `` recurrence '' or persistence .\
RESULTS	The corresponding number was 21 ( 30 % ) of the 70 women whose partner received placebo ( chi ( 2 ) p = not significant ) .\
RESULTS	Of the 84 couples in which the woman was cured by the first week 's visit and who completed the study ; there were five recurrences ( 11.6 % ) among the 43 women whose partner received clindamycin and nine ( 22.0 % ) of the 41 whose partner received placebo ( chi ( 2 ) p = not significant ) .\
CONCLUSIONS	This study indicates that vaginal clindamycin is effective and safe in the treatment of bacterial vaginosis , but it does not support the suggestion that male treatment markedly reduces the short term recurrence rate .\
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###8907444\
OBJECTIVE	This study assessed the effect of a wheeled walking aid on disability , oxygenation , and breathlessness in patients with severe disability secondary to chronic irreversible airflow limitation .\
METHODS	Eleven subjects with chronic irreversible airflow limitation , mean forced expired volume in 1 second ( FEV1 ) 0.71 L + / - .33 L , were studied .\
METHODS	Subjects performed four 6-minute walk tests , two on each of two study days , twice unaided and twice with the assistance of a wheeled walking aid .\
METHODS	A randomized cross-over design was used .\
METHODS	All subjects were oriented to 6-minute walk tests , use of bronchodilators was controlled , and standard encouragement was given during each walk test .\
METHODS	Outcome measures were the distance walked in 6 minutes , change in oxyhemoglobin saturation during the walk , and breathlessness using a modified Borg Scale .\
RESULTS	The use of a wheeled walker resulted in a significant increase in 6-minute walking distance , a significant reduction in hypoxemia with walking and a significant reduction in breathlessness during the walk test .\
CONCLUSIONS	The use of a wheeled walker resulted in significant decreases in disability , hypoxemia , and breathlessness during a 6-minute walk test .\
CONCLUSIONS	By reducing disability and breathlessness , a wheeled walker may improve quality of life in individuals with severe impairment in lung function .\
}