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[ "This randomized , single center , examiner-blind , controlled , parallel-group , 4-week clinical study compared the antiplaque/anti-gingivitis efficacy of an essential oil ( EO ) containing mouthrinse versus a 0.075 % cetylpyridinium chloride ( CPC ) containing mouthrinse .", "A 5 % hydroalcohol solution was included as a control group .", "165 systemically healthy volunteers ( 18-72 years of age ) , with mild to moderate plaque-related gingivitis were enrolled in this clinical trial ; 162 subjects completed the study .", "At baseline and 4-week visits , subjects received an oral examination , gingivitis ( MGI ) , gingival bleeding ( BI ) and plaque ( PI ) assessments .", "Following randomization , subjects began rinsing with 20 mL of the assigned mouthrinse for 30 seconds , in conjunction with their usual oral hygiene , twice daily for the duration of the study .", "All rinses were well tolerated by the subjects .", "EO was statistically significantly superior to CPC with a reduction in mean MGI of 5.9 % , and in mean PI of 6.4 % .", "Statistically significant reductions in gingivitis , bleeding and plaque were observed for both EO and CPC when compared to the negative control ; mean MGI and mean PI were reduced by 13.0 % and 18.9 % for EO and by 7.6 % and 13.3 % for CPC .", "EO also statistically significantly reduced the proportion of gingival bleeding sites compared to CPC by 7.6 % ( P = 0.012 ) and compared to control by 10.6 % ( P < 0.001 ) .", "For the post hoc sitewise analyses , at 4 weeks , the mean percentage of healthy sites for EO , CPC and Control were 7.4 % , 1.1 % and 0.8 % , respectively and the mean percentage of virtually plaque free sites for EO , CPC and control were 5.4 % , 3.8 % and 0.4 % respectively .", "The mean percentages of more inflamed gingival sites for EO , CPC and control were 20.4 % , 26.2 % and 45.7 % , respectively .", "The mean percentage of tooth surfaces with heavier accumulations of plaque ( PI scores 3 ) was 50.9 % for EO , 56.1 % for CPC and 81.1 % for control .", "Reduction of gingival inflammation and dental plaque was statistically significantly superior for EO compared to both 0.075 % CPC and negative control .", "Both marketed antimicrobial mouthrinses showed a beneficial result in gingival health and in reducing plaque accumulation as early as 4 weeks ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS" ]

[ "To compare the benefits and harms of third-wave cognitive therapy versus mentalisation-based therapy in a small sample of depressed participants .", "The trial was conducted at an outpatient psychiatric clinic for non-psychotic patients in Roskilde , Denmark .", "44 consecutive adult participants diagnosed with major depressive disorder .", "18weeks of third-wave cognitive therapy ( n = 22 ) versus 18weeks of mentalisation-based treatment ( n = 22 ) .", "The primary outcome was the Hamilton Rating Scale for Depression ( HDRS ) at end of treatment ( 18weeks ) .", "Secondary outcomes were : remission ( HDRS < 8 ) , Beck 's Depression Inventory , Symptom Checklist 90 Revised and The WHO-Five Well-being Index 1999 .", "The trial inclusion lasted for about 2years as planned but only 44 out of the planned 84 participants were randomised .", "Two mentalisation-based participants were lost to follow-up .", "The unadjusted analysis showed that third-wave participants compared with mentalisation-based participants did not differ significantly regarding the 18weeks HDRS score ( 12.9 vs 17.0 ; mean difference -4.14 ; 95 % CI -8.30 to 0.03 ; p = 0.051 ) .", "In the analysis adjusted for baseline HDRS score , the difference was favouring third-wave cognitive therapy ( p = 0.039 ) .", "At 18weeks , five of the third-wave participants ( 22.7 % ) were in remission versus none of the mentalisation-based participants ( p = 0.049 ) .", "We recorded no suicide attempts or suicides during the intervention period in any of the 44 participants .", "No significant differences were found between the two intervention groups on the remaining secondary outcomes .", "Third-wave cognitive therapy may be more effective than mentalisation-based therapy for depressive symptoms measured on the HDRS .", "However , more randomised clinical trials are needed to assess the effects of third-wave cognitive therapy and mentalisation-based treatment for depression .", "Registered with Clinical Trials government identifier : NCT01070134 ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Depression is a debilitating mental health problem that tends to run a chronic , recurrent course .", "Even when effectively treated , relapse and recurrence rates remain high .", "Accordingly , interventions need to focus not only on symptom reduction , but also on reducing the risk of relapse by targeting depression-related disturbances that persist into remission .", "We are addressing this need by investigating the efficacy , acceptability and feasibility of a MEmory Specificity Training ( MEST ) programme , which directly targets an enduring cognitive marker of depression - reduced autobiographical memory specificity .", "Promising pilot data suggest that training memory specificity ameliorates this disturbance and reduces depressive symptoms .", "A larger , controlled trial is now needed to examine the efficacy of MEST .", "This trial compares MEST to an education and support ( ES ) group , with an embedded mechanism study .", "In a single blind , parallel cluster randomised controlled trial , 60 depressed individuals meeting diagnostic criteria for a current major depressive episode will be recruited from the community and clinical services .", "Using a block randomisation procedure , groups of 5 to 8 participants will receive five weekly sessions of MEST ( n = 30 ) or education and support ( n = 30 ) .", "Participants will be assessed immediately post-treatment , and at 3 - and 6-months post-treatment ( MEST group only for 6-month follow-up ) .", "Depressive symptoms at 3-month follow-up will be the primary outcome .", "Secondary outcomes will be change in depressive status and memory specificity at post-treatment and 3-months .", "The 6-month follow-up of the MEST group will allow us to examine whether treatment gains are maintained .", "An explanatory question will examine variables mediating improvement in depression symptoms post-treatment and at 3-month follow-up .", "This trial will allow us to investigate the efficacy of MEST , whether treatment gains are maintained , and the mechanisms of change .", "Evidence will be gathered regarding whether this treatment is feasible and acceptable as a low-intensity intervention .", "If efficacy can be demonstrated , the results will support MEST as a treatment for depression and provide the foundation for a definitive trial .", "NCT01882452 ( ClinicalTrials.gov ) , registered on 18 June 2013 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "To use Fourier-domain optical coherence tomography ( OCT ) to evaluate the wound characteristics of clear corneal incisions ( CCIs ) created with a metal or diamond blade in cataract surgery .", "Department of Ophthalmology , Institute of Vision Research , Yonsei University College of Medicine , Seoul , South Korea .", "Prospective comparative observational study .", "Patients who had cataract surgery were randomized into 2 groups based on whether a metal blade ( Group 1 , 37 eyes ) or diamond blade ( Group 2 , 33 eyes ) was used to create a 2.8 mm temporal CCI .", "One day , 1 week , and 1 month postoperatively , structural characteristics of the CCI were analyzed using RTVue-100 Fourier-domain OCT. .", "Parameters included incision angle , corneal thickness , epithelial or endothelial gaps , and Descemet membrane detachment .", "Visual acuity , surgically induced astigmatism ( SIA ) , and ocular aberrations were evaluated .", "There was a significant difference in corneal thickness at the 1.0 mm temporal side from midpoint .", "The mean uncorrected distance visual acuity in Group 2 ( 33 eyes ) improved significantly over time .", "In both groups , corneal thickness at the midpoint , 1.0 mm temporal side , and 1.0 mm nasal side from the midpoint of the incision significantly decreased over time .", "At all timepoints , temporal and nasal thickness in Group 2 was significantly greater than in Group 1 ( 37 eyes ) , with the exception of temporal thickness at 1 month .", "In both groups , wound healing was reliable over time .", "There were no significant between-group differences in SIA or changes in aberrations .", "Corneal thickness at the incision site showed a significant difference between the 2 groups .", "Both groups achieved structural stabilization .", "No author has a financial or proprietary interest in any material or method mentioned ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Whereas emollients are integral to the long-term management of atopic dermatitis ( AD ) , the evidence for their efficacy in disease flares is limited .", "We aimed to investigate the stand-alone efficacy of an emollient formulation with regard to improvement of the clinical symptoms , skin barrier function and reduction of pathogenic bacterial colonization in acute stage of AD .", "Twenty AD volunteers aged 12-65 years with symmetric , mild to moderately severe inflammatory lesions on the forearms/arms were recruited for the study .", "At inclusion , the forearms/arms of each volunteer were randomized to receive for 1 week either an o/w formulation containing licochalcone A ( Glycyrrhiza Inflata root extract ) , decanediol , menthoxypropanediol and -6 - fatty acids ( emollient arm ) or 1 % hydrocortisone ( HC arm ) ; after 1 week , the application of the emollient and HC were discontinued and the volunteers applied a w/o emollient containing licochalcone A and -6 - fatty acids on both arms for further 3 weeks .", "The outcomes included reduction of the clinical and itch severity , decrease in S.aureus colonization , improvement of the barrier function , skin hydration and skin tolerability assessed after 1 week ( D7 ) and after 4 weeks ( D28 ) respectively .", "In both arms , there was a significant decrease in the severity score , itch intensity , erythema and TEWL on D7 and D28 compared to baseline .", "In addition , emollient use resulted in pronounced decrease in S.aureus colonization and significant increase of skin hydration on D7 .", "The comparison of the outcomes , based on percentage change from baseline , showed no significant differences between the emollient and HC arm at any time point .", "The results of the study indicate that the 1-week stand-alone application of an emollient , tailored to target inflammation , pruritus , compromised barrier function and pathogenic bacterial colonization may offer benefit for the improvement of mild to moderately severe localized flares of AD ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To determine whether a bundled intervention can increase detection of delirium and facilitate safer use of high-risk medications .", "Pre-post interventional trial .", "Large academic medical center .", "Individuals aged 70 and older ( n = 19,949 ) admitted between May 1 , 2008 , September 30 , 2011 .", "Individuals aged 80 and older admitted after April 26 , 2010 , received the intervention , those aged 80 and older admitted before were primary controls , and those aged 70 to 79 were concurrent controls .", "The intervention uses a checklist promoting delirium prevention , recognition and management , and modifies the computerized provider order entry system to provide care focused on elderly adults .", "Frequency of orders for activating the rapid response team for altered mental status , frequency of orders for haloperidol in excess of 0.5 mg or intravenous ( IV ) morphine in excess of 2 mg , and discharge disposition .", "Participants receiving the intervention had a mean age of 86.1 4.6 ; 58.2 % were female .", "The number of orders to activate the rapid response team for altered mental status increased in participants receiving the bundle and in controls ( odds ratio ( OR ) for the difference of differences = 1.23 ( 95 % confidence interval ( CI ) = 0.68-2 .24 , P = .49 ) ) .", "Participants receiving the bundle were less likely to receive more than 0.5 mg of IV , intramuscular , or oral haloperidol ( OR = 0.60 , 95 % CI = 0.39-0 .91 , P = .02 ) and more than 2 mg of IV morphine ( OR = 0.52 , 95 % CI = 0.42-0 .63 , P < .001 ) .", "Participants who received the bundle were more likely to be discharged home than to extended care facilities ( OR = 1.18 , 95 % CI = 1.04-1 .35 , P = .01 ) .", "An intervention focused on delirium prevention and recognition by bedside staff combined with computerized decision support facilitates safer prescribing of high-risk medications and possibly results in less need for extended care ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "The technical difficulty in the revascularization of the circumflex artery territory with off-pump surgery may compromise the outcome of this method in clinical follow-up .", "We aimed to evaluate cardiac events in patients with stable coronary artery disease and severe obstruction of the circumflex system , undergoing coronary artery bypass grafting ( CABG ) with or without cardiopulmonary bypass .", "MASS III was a single-centre study that evaluated 308 patients with multivessel coronary artery disease randomized to on-pump ( 153 ) or off-pump ( 155 ) CABG .", "Of this total , 260 ( 84.4 % ) patients had , on coronary angiography , at least one 70 % obstruction in the circumflex territory ( 141 on-pump and 119 off-pump ) .", "The combined outcome was death , myocardial infarction , target vessel revascularization ( angioplasty or surgery ) or hospitalization for cardiac causes .", "Variables with possible associations ( P < 0.1 ) were included in the multivariate analysis .", "The two groups were well matched for demographics and clinical and angiographic characteristics .", "After 5 years of follow-up , off-pump CABG had higher combined events than on-pump had : 25 ( 21 % ) vs 17 ( 12 % ) , hazard ratio 1.88 , 95 % confidence interval 1.02-3 .48 , P = 0.041 .", "In the multivariate model with the inclusion of the following variables : age ( P = 0.09 ) and complete revascularization ( P = 0.68 ) , off-pump surgery remained as a predictor of combined events in 5 years , P = 0.03 .", "In patients with multivessel coronary artery disease and severe lesions in the circumflex territory , off-pump coronary artery bypass surgery resulted in a higher incidence of cardiac events at 5-year follow-up .", "ISRCTN59539154 ( http://www.controlled-trials.com ) ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "This clinical study was conducted to investigate the effects of dexmedetomidine ( DEX ) combined with propofol on vital signs and anaesthetic depth in patients .", "Ninety patients with ASA 1-2 requiring painless colonoscopy for colonic polyps resection were randomized to receive DEX 0.3 micro ; g/kg ( group D , n = 45 ) followed by propofol 1 mg/kg or propofol 2 mg/kg ( group C , n = 45 ) , and according to the body activity and operation time , additional doses of propofol ( 0.2-0 .5 mg/kg ) were given .", "The full recovery time , operation time , consumed dose of propofol , mean arterial pressure ( MAP ) , heart rate ( HR ) , hemoglobin oxygen saturation levels ( SPO ) and NTI were recorded .", "The SPOrecover time and the consumed dose of propofol in group D were decreased compared to those in group C ( P < 0.01 ) .", "The rate of the body activity in group D was lower than that in group C ( P < 0.05 ) .", "The NTI in group C was lower than that in group D ( P < 0.05 ) .", "The HR and MAP were similar in both groups .", "Under Narcotrend monitoring , the value of DEX combined with low dose of propofol in colonoscopy for colonic polyps resection is to reach more reasonable depth of anesthesia to reduce adverse responses and the dose of propofol ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To estimate whether a continuous infusion of intraperitoneal local anaesthetic for 48hours following laparoscopic hysterectomy reduced the need for opioids delivered with a patient-controlled analgesia pump .", "Double-blind randomised placebo-controlled trial .", "District general hospital in the UK .", "Women undergoing a laparoscopic hysterectomy for a benign indication .", "Women were randomised to receive either 0.5 % levobupivicaine or 0.9 % normal saline via an ON-Q elastomeric pump for 48hours postoperatively .", "The amount of opioids used via the patient-controlled analgesia pump was recorded and pain was measured using an 11-point Box Scale .", "The primary outcome was the amount of patient-administered morphine used over the first 48 postoperative hours .", "Secondary outcomes were length of hospital stay , oral analgesia use and level of patient-reported pain .", "Sixty women participated and completed the trial .", "There was no difference ( P = 0.59 ) in the median amount of patient-administered morphine used between the levobupivicaine ( 23mg ) and placebo ( 18.5 mg ) groups ; median group difference 3.0 ( 95 % CI -7.0 to 14.0 ) .", "There was also no difference in the length of hospital stay with 40 % of the treatment group remaining in hospital > 48hours compared with 30 % of the placebo group ( P = 0.08 ) .", "Pain scores at all postoperative time points remained similar , with a median group difference in pain scores of 1.0 ( 95 % CI -1.0 to 2.0 ) at the end of the first postoperative day .", "Continuous infusion of 0.5 % levobupivicaine into the peritoneal cavity following laparoscopic hysterectomy does not have any opioid-sparing effects ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Screen-related behaviours are highly prevalent in schoolchildren .", "Considering the adverse health effects and the relation of obesity and screen time in childhood , efforts to affect screen use in children are warranted .", "Parents have been identified as an important influence on children 's screen time and therefore should be involved in prevention programmes .", "The aim was to examine the mediating role of family-related factors on the effects of the school-based family-focused UP4FUN intervention aimed at screen time in 10 - to 12-year-old European children ( n child-parent dyads = 1940 ) .", "A randomised controlled trial was conducted to test the six-week UP4FUN intervention in 10 - to 12-year-old children and one of their parents in five European countries in 2011 ( n child-parent dyads = 1940 ) .", "Self-reported data of children were used to assess their TV and computer/game console time per day , and parents reported their physical activity , screen time and family-related factors associated with screen behaviours ( availability , permissiveness , monitoring , negotiation , rules , avoiding negative role modeling , and frequency of physically active family excursions ) .", "Mediation analyses were performed using multi-level regression analyses ( child-school-country ) .", "Almost all TV-specific and half of the computer-specific family-related factors were associated with children 's screen time .", "However , the measured family-related factors did not mediate intervention effects on children 's TV and computer/game console use , because the intervention was not successful in changing these family-related factors .", "Future screen-related interventions should aim to effectively target the home environment and parents ' practices related to children 's use of TV and computers to decrease children 's screen time .", "The study is registered in the International Standard Randomised Controlled Trial Number Register ( registration number : ISRCTN34562078 ) ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "To explore an optimal anesthesia method with less impact on hemodynamics and electrocardiogram ( ECG ) of old patients with coronary artery disease ( CHD ) during abdominal operation .", "The 133 CHD patients waiting for abdominal operation were randomly divided into continuous epidural anesthesia ( EA ) group , general anesthesia group ( GA ) and combined spinal-epidural anesthesia ( CSEA ) group .", "Continuous monitoring was carried out during operation and mean arterial pressure ( MAP ) , heart rate ( HR ) , oxygen saturation ( SaO2 ) , abnormal ECG were measured respectively at different time for comparison and the differences of the above hemodynamic parameters and abnormal ECG features were compared among the 3 groups .", "At the 15 min and 30 min point after anesthesia , SaO2 in GA group was significantly increased compared to that in the EA group ( P < 0.05 ) .", "At 15 min , 30 min and 60 min point after anesthesia , MAP in CSEA group was significantly increased compared to that in the EA group ( P < 0.05 ) .", "At 30 min point after anesthesia , HR in CSEA group was increased significantly compared to the EA group ( P < 0.05 ) .", "At 15 min and 30 min point after anesthesia , SaO2 in the CSEA group was increased significantly compare to the EA group ( P < 0.05 ) .", "Compared with preanesthesia ( T0 ) in EA group , MAP , HR and SaO2 decreased significantly at 15 , 30 and 60 min after anesthesia ( P < 0.05 ) .", "The fluctuation of the three parameters in GA and CSEA groups were relatively small ( P > 0.05 ) .", "As well as the comparison of abnormal ECG among the 3 groups was concerned , the incidence of ST-T changes in GA and CSEA groups were significantly lower than that in EA group at the time of 15 min , 30 min and 60 min after anesthesia and at the time of surgery termination ( P < 0.05 , P < 0.01 ) .", "The incidence of arrhythmia in GA and CSEA groups were significantly lower than that in EA group at the time of 15 min , 30 min and 60 min after anesthesia ( P < 0.05 , P < 0.01 ) .", "Compared with T0 in the same group , the incidences of ST-T changes and arrhythmia in GA or CSEA group at the time of 15 , 30 and 60 min after anesthesia and at the time of surgery termination were significantly lower than that before anesthesia ( P < 0.05 , P < 0.01 ) .", "GA and CSEA have less impact on hemodynamics and have smaller incidence of abnormal ECG of old CHD patients with abdominal operation ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Lower levels of global DNA methylation in tissue and blood have been associated with increased cancer risk .", "Conversely , cross-sectional analyses of healthier lifestyle patterns have been associated with higher levels of global DNA methylation .", "In this trial , we explored the associations between changes in lifestyle modifications ( diet , weight loss ) , metabolic markers , and global epigenetic biomarkers in white blood cells .", "Study participants were Hispanic , African American , and Afro-Caribbean overweight and sedentary female breast cancer survivors ( n = 24 ) who participated in a larger randomized , crossover , pilot study of a 6-mo weight loss intervention and who had available blood specimens .", "Anthropometric measures , a food-frequency questionnaire , and peripheral blood were collected at baseline , 6 mo , and 12 mo. .", "Plasma samples were analyzed for metabolic markers ( insulin , glucose ) .", "We measured DNA methylation of long interspersed nucleotide element 1 ( LINE-1 ) and satellite 2 by pyrosequencing and MethyLight , respectively , and global DNA methylation by the luminometric methylation assay ( LUMA ) .", "DNA methylation of LINE-1 was statistically significantly elevated at 6 mo [ 75.5 % vs. 78.5 % ( P < 0.0001 ) ] and 12 mo [ 75.5 % vs. 77.7 % ( P < 0.0001 ) ] , compared to baseline .", "Over a 12-mo period , changes in percentage body fat and plasma glucose concentrations were positively associated with LINE-1 DNA methylation ( = 0.19 , P = 0.001 ) and LUMA DNA methylation levels ( = 0.24 , P = 0.02 ) , respectively .", "Similarly , 12-mo changes in dietary measures such as vegetable ( = 0.009 , P = 0.048 ) , protein ( = 0.04 , P = 0.001 ) , and total caloric ( = 0.05 , P = 0.01 ) intake were positively associated with changes in LUMA DNA methylation , as was intake of fruit positively associated with changes in LINE-1 DNA methylation ( = 0.004 , P = 0.02 ) .", "Our hypothesis-generating results suggest that lifestyle modifications may be associated with changes in global DNA methylation detectable at 6 and 12 mo. .", "These biomarkers may be useful intermediate biomarkers to use in future intervention trials .", "This trial was registered at clinicaltrials.gov as NCT00811824 ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Substance use problems in childhood and adolescence can severely impact youth 's physical and mental well-being .", "When substance use is initiated early , the risk for moving from hazardous substance use to substance use disorders ( SUD ) is particularly high to developmentally induced biological and psychological vulnerability towards chronic trajectories in youth .", "Thus , risk factors for developing SUD should be addressed early in life by adequate preventive measures reaching out to children , adolescents , and their families .", "The study described in this protocol will test the effectiveness of the German adaptation of the Strengthening Families Program for Parents and Youth 10-14 ( SFP 10-14 ) aimed at ten to 14 year old adolescents and their caregivers .", "The study is conducted in four large German cities by counselling centres in the areas of youth welfare , social work and addiction aid .", "The effectiveness of the manualised group programme `` Familien Strken '' consisting of seven sessions and four booster-sessions is tested among N = 288 children and participating parents in a multicentre randomised controlled trial with standardised assessment instruments .", "The control condition receives a minimal 2-hour intervention on parenting delivered in a school setting .", "Data are collected shortly before and after as well as six and 18 months after the intervention .", "We expect to replicate the favourable effects of the SFP 10-14 programme in the United States in the area of substance use initiation , family functioning and individual psychosocial adjustment .", "The trial is expected to contribute to the growing literature on family-based preventive interventions , their effectiveness and feasibility .", "It is in line with several other current European efforts aimed at strengthening families against the detrimental effects of substance abuse in youth .", "The results of these trials will expand our knowledge on adapting evidence-based interventions and delivering them in diverse cultures and settings .", "Current Controlled Trials ISRCTN90251787 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "There is excess cardiovascular mortality in patients with chronic obstructive pulmonary disease .", "Aortic stiffness , an independent predictor of cardiovascular risk , and systemic and airway inflammation are increased in patients with the disease .", "Statins modulate aortic stiffness and have anti-inflammatory properties .", "A proof-of-principle , double-blind , randomized trial determined if 6 weeks of simvastatin 20 mg once daily reduced aortic stiffness and systemic and airway inflammation in patients with chronic obstructive pulmonary disease .", "Stable patients ( n = 70 ) were randomized to simvastatin ( active ) or placebo .", "Pre-treatment and post-treatment aortic stiffness , blood pressure , spirometry , and circulating and airway inflammatory mediators and lipids were measured .", "A predefined subgroup analysis was performed where baseline aortic pulse wave velocity ( PWV ) was > 10 m/sec .", "Total cholesterol dropped in the active group .", "There was no significant change in aortic PWV between the active group and the placebo group ( -0.7 m/sec , P = 0.24 ) .", "In those with aortic stiffness > 10 m/sec ( n = 22 ) , aortic PWV improved in the active group compared with the placebo group ( -2.8 m/sec , P = 0.03 ) .", "Neither systemic nor airway inflammatory markers changed .", "There was a nonsignificant improvement in aortic PWV in those taking simvastatin 20 mg compared with placebo , but in those with higher baseline aortic stiffness ( a higher risk group ) a significant and clinically relevant reduction in PWV was shown ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Depression , cognitive impairment , and other nonmotor symptoms ( NMSs ) are common early in Parkinson disease ( PD ) and may be in part due to disease-related dopamine deficiency .", "Many patients with PD are treated with antidepressants for NMSs , and the effect of the combination of PD medications that enhance dopamine neurotransmission and antidepressants on NMSs has not been studied .", "We report the effects of the addition of a monoamine oxidase B inhibitor , rasagiline , to antidepressant treatment in PD .", "To evaluate the effect of rasagiline on depression , cognition , and other PD NMSs in patients taking an antidepressant in the Attenuation of Disease Progression With Azilect Given Once Daily ( ADAGIO ) study .", "The ADAGIO study was a double-blind , placebo-controlled , delayed-start trial of rasagiline in de novo PD .", "In this exploratory post hoc analysis , we analyzed patients taking an antidepressant during the 36-week phase 1 period , in which patients were randomized to rasagiline ( 1 or 2 mg/d ) or placebo .", "We evaluated the change in NMSs in patients taking an antidepressant and rasagiline compared with those taking placebo .", "The NMSs were assessed by Movement Disorder Society-sponsored revision of the Unified Parkinson 's Disease Rating Scale Nonmotor Experiences of Daily Living , the original Unified Parkinson 's Disease Rating Scale , and the Parkinson Fatigue Scale .", "A total of 191 of the 1174 patients ( 16.3 % ) were treated with antidepressants during phase 1 and provided efficacy data .", "Depression and cognition scores revealed significantly less worsening in the rasagiline group compared with the placebo group ( differences in Movement Disorder Society-sponsored revision of the Unified Parkinson 's Disease Rating Scale item-adjusted means [ SEs ] , -0.19 [ 0.10 ] , P = .048 , and -0.20 [ 0.05 ] , P < .001 , respectively ) .", "Parkinson Fatigue Scale ( mean [ SE ] difference,-0 .42 [ 0.09 ] , P < .001 ) and daytime sleepiness ( mean [ SE ] difference,-0 .24 [ 0.09 ] , P = .006 ) scores also revealed significantly less worsening in the rasagiline group compared with placebo .", "There was a nonsignificant trend toward less worsening in apathy and no significant between-group differences in anxiety or sleep .", "The effect on depression remained significant after controlling for improvement in motor symptoms ( mean [ SE ] difference,-0 .23 [ 0.09 ] , P = .009 ) .", "There were no serious adverse events in the combined rasagiline-antidepressant group suggestive of serotonin syndrome .", "The combination of rasagiline and antidepressants in patients with de novo PD is associated with reduced worsening of a range of NMSs in preliminary analyses .", "Adverse effects appear uncommon with this combination .", "These findings suggest a role for dopamine-enhancing therapies in NMSs in early PD and encourage further study and confirmation .", "clinicaltrials.gov Identifier : NCT00256204 ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "The prevalence of obesity has markedly increased in patients with chronic kidney disease ( CKD ) .", "Studies on the impact of exercise focusing on obese CKD patients are scarce .", "Therefore , we aimed to investigate the effect of aerobic exercise performed either in an exercise centre or at home on visceral fat in overweight non-dialysed CKD patients .", "Twenty-seven sedentary men ( 52.1 9.5 years , body mass index 30.4 3.8 kg/m ( 2 ) , estimated glomerular filtration rate ( eGFR ) 27.5 11.6 mL/min ) were randomly assigned to a centre-based exercise group ( n = 10 ) , home-based exercise group ( n = 8 ) or control group ( n = 9 ) .", "The aerobic training was prescribed according to ventilatory threshold and performed three times per week during 12 weeks .", "Body composition was assessed by dual energy X-ray absorptiometry ( DEXA ) and the distribution of abdominal fat by computed tomography .", "In the centre-based group , visceral fat and waist circumference decreased 6.4 6.4 mm ( P < 0.01 ) and 2.0 2.3 cm ( P = 0.03 ) and leg lean mass increased 0.5 0.4 kg ( P < 0.01 ) .", "No significant changes were observed in the home-based group .", "Visceral fat increased 5.0 4.4 mm in the control group ( P = 0.01 ) .", "In relation to the control , a group-by-time interaction was significant for visceral fat and waist circumference for both exercise groups and for leg lean mass for the centre-based group .", "Mean blood pressure decreased in both exercise groups ( centre-based 13 % , P < 0.01 and home-based 10 % , P = 0.03 ) and eGFR increased 3.6 4.6 mL/min ( P = 0.03 ) in the centre-based group .", "These parameters remained unchanged in the control group .", "Centre-based aerobic exercise is an effective approach to reduce visceral fat besides promoting relevant clinical benefits in male overweight CKD patients ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Lowering intraocular pressure ( IOP ) is currently the only therapeutic approach in primary open-angle glaucoma .", "and the fixed-combination medications are needed to achieve sufficiently low target IOP .", "A multicenter prospective study in the Chinese population was needed to confirm the safety and efficacy of Bimatoprost/Timolol Fixed Combination Eye Drop in China .", "In this study , we evaluated the safety and efficacy of Bimatoprost/Timolol Fixed Combination with concurrent administration of its components in Chinese patients with open-angle glaucoma or ocular hypertension .", "In this multicenter , randomized , double-masked , parallel controlled study , patients with open-angle glaucoma or ocular hypertension who were insufficiently responsive to monotherapy with either topical - blockers or prostaglandin analogues were randomized to one of two active treatment groups in a 1:1 ratio at 11 Chinese ophthalmic departments .", "Bimatoprost/timolol fixed combination treatment was a fixed combination of 0.03 % bimatoprost and 0.5 % timolol ( followed by vehicle for masking ) once daily at 19:00 P.M. and concurrent treatment was 0.03 % bimatoprost followed by 0.5 % timolol once daily at 19:00 P.M.", "The primary efficacy variable was change from baseline in mean diurnal intraocular pressure ( IOP ) at week 4 visit in the intent-to-treat ( ITT ) population .", "Primary analysis evaluated the non-inferiority of bimatoprost / timolol fixed combination to concurrent with respect to the primary variable using a confidence interval ( CI ) approach .", "Bimatoprost/timolol fixed combination was to be considered non-inferior to concurrent if the upper limit of the 95 % CI for the between-treatment ( bimatoprost/timolol fixed combination minus concurrent ) difference was 1.5 mmHg .", "Adverse events were collected and slit-lamp examinations were performed to assess safety .", "Between-group comparisons of the incidence of adverse events were performed using the Pearson chi-square test or Fisher 's exact test .", "Of the enrolled 235 patients , 121 patients were randomized to receive bimatoprost/timolol fixed combination and , 114 patients were randomized to receive concurrent treatment .", "At baseline the mean value of mean diurnal IOP was ( 25.20 3.06 ) mmHg in the bimatoprost/timolol fixed combination group and ( 24.87 3.88 ) mmHg in the concurrent group .", "The difference between the treatment groups was not statistically significant .", "The mean change from baseline in mean diurnal IOP ( standard deviation ) in the bimatoprost/timolol fixed combination group was ( -9.38 4.66 ) mmHg and it was ( -8.93 4.25 ) mmHg in the concurrent group ( P < 0.01 ) .", "The difference between the two treatment groups ( bimatoprost/timolol fixed combination minus concurrent ) in the change from baseline of mean diurnal IOP was -0.556 mmHg ( 95 % CI : -1.68 , 0.57 , P = 0.330 ) .", "The upper limit of the 95 % CI was less than 1.5 mmHg , the predefined margin of non-inferiority .", "Adverse events occurred in 26.4 % ( 32/121 ) of the bimatoprost/timolol fixed combination patients and 30.7 % ( 35/114 ) of the concurrent patients .", "The most frequent adverse event was conjunctival hyperemia , which was reported as treatment related in 16.5 % ( 20/121 ) in the bimatoprost/timolol fixed combination group and 18.4 % ( 21/114 ) in the concurrent group ( P > 0.05 ) .", "Bimatoprost/Timolol Fixed Combination administered in Chinese patients with open-angle glaucoma or ocular hypertension was not inferior to concurrent dosing with the individual components .", "Safety profiles were similar between the treatment groups ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The particle size and structure of masticated almonds have a significant impact on nutrient release ( bioaccessibility ) and digestion kinetics .", "The goals of this study were to quantify the effects of mastication on the bioaccessibility of intracellular lipid of almond tissue and examine microstructural characteristics of masticated almonds .", "In a randomized , subject-blind , crossover trial , 17 healthy subjects chewed natural almonds ( NAs ) or roasted almonds ( RAs ) in 4 separate mastication sessions .", "Particle size distributions ( PSDs ) of the expectorated boluses were measured by using mechanical sieving and laser diffraction ( primary outcome ) .", "The microstructure of masticated almonds , including the structural integrity of the cell walls ( i.e. , dietary fiber ) , was examined with microscopy .", "Lipid bioaccessibility was predicted by using a theoretical model , based on almond particle size and cell dimensions , and then compared with empirically derived release data .", "Intersubject variations ( n = 15 ; 2 subjects withdrew ) in PSDs of both NA and RA samples were small ( e.g. , laser diffraction ; CV : 12 % and 9 % , respectively ) .", "Significant differences in PSDs were found between these 2 almond forms ( P < 0.05 ) .", "A small proportion of lipid was released from ruptured cells on fractured surfaces of masticated particles , as predicted by using the mathematical model ( 8.5 % and 11.3 % for NAs and RAs , respectively ) .", "This low percentage of lipid bioaccessibility is attributable to the high proportion ( 35-40 % ) of large particles ( > 500 m ) in masticated almonds .", "Microstructural examination of the almonds indicated that most intracellular lipid remained undisturbed in intact cells after mastication .", "No adverse events were recorded .", "Following mastication , most of the almond cells remained intact with lipid encapsulated by cell walls .", "Thus , most of the lipid in masticated almonds is not immediately bioaccessible and remains unavailable for early stages of digestion .", "The lipid encapsulation mechanism provides a convincing explanation for why almonds have a low metabolizable energy content and an attenuated impact on postprandial lipemia ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Neurocysticercosis causes a substantial burden of seizure disorders worldwide .", "Treatment with either praziquantel or albendazole has suboptimum efficacy .", "We aimed to establish whether combination of these drugs would increase cysticidal efficacy and whether complete cyst resolution results in fewer seizures .", "We added an increased dose albendazole group to establish a potential effect of increased albendazole concentrations .", "In this double-blind , placebo-controlled , phase 3 trial , patients with viable intraparenchymal neurocysticercosis were randomly assigned to receive 10 days of combined albendazole ( 15 mg/kg per day ) plus praziquantel ( 50 mg/kg per day ) , standard albendazole ( 15 mg/kg per day ) , or increased dose albendazole ( 225 mg/kg per day ) .", "Randomisation was done with a computer generated schedule balanced within four strata based on number of cysts and concomitant antiepileptic drug .", "Patients and investigators were masked to group assignment .", "The primary outcome was complete cyst resolution on 6-month MRI .", "Enrolment was stopped after interim analysis because of parasiticidal superiority of one treatment group .", "Analysis excluded patients lost to follow-up before the 6-month MRI .", "This trial is registered with ClinicalTrials.gov , number NCT00441285 .", "Between March 3 , 2010 and Nov 14 , 2011 , 124 patients were randomly assigned to study groups ( 41 to receive combined albendazole plus praziquantel [ 39 analysed ] , 43 standard albendazole [ 41 analysed ] , and 40 increased albendazole [ 38 analysed ] ) .", "25 ( 64 % ) of 39 patients in the combined treatment group had complete resolution of brain cysts compared with 15 ( 37 % ) of 41 patients in the standard albendazole group ( rate ratio [ RR ] 175 , 95 % CI 110-279 , p = 0014 ) .", "20 ( 53 % ) of 38 patients in the increased albendazole group had complete cyst resolution at 6-month MRI compared with 15 ( 37 % ) of 41 patients in the standard albendazole group ( RR 144 , 95 % CI 087-238 , p = 0151 ) .", "No significant differences in adverse events were reported between treatment groups ( 18 in combined treatment group , 11 in standard albendazole group , and 19 in increased albendazole group ) .", "Combination of albendazole plus praziquantel increases the parasiticidal effect in patients with multiple brain cysticercosis cysts without increased side-effects .", "A more efficacious parasiticidal regime without increased treatment-associated side-effects should improve the treatment and long term prognosis of patients with neurocysticercosis .", "National Institute of Neurological Disorders and Stroke ( NINDS ) , National Institutes of Health ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Critical illness results in disability and reduced health-related quality of life ( HRQOL ) , but the optimum timing and components of rehabilitation are uncertain .", "To evaluate the effect of increasing physical and nutritional rehabilitation plus information delivered during the post-intensive care unit ( ICU ) acute hospital stay by dedicated rehabilitation assistants on subsequent mobility , HRQOL , and prevalent disabilities .", "A parallel group , randomized clinical trial with blinded outcome assessment at 2 hospitals in Edinburgh , Scotland , of 240 patients discharged from the ICU between December 1 , 2010 , and January 31 , 2013 , who required at least 48 hours of mechanical ventilation .", "Analysis for the primary outcome and other 3-month outcomes was performed between June and August 2013 ; for the 6 - and 12-month outcomes and the health economic evaluation , between March and April 2014 .", "During the post-ICU hospital stay , both groups received physiotherapy and dietetic , occupational , and speech/language therapy , but patients in the intervention group received rehabilitation that typically increased the frequency of mobility and exercise therapies 2 - to 3-fold , increased dietetic assessment and treatment , used individualized goal setting , and provided greater illness-specific information .", "Intervention group therapy was coordinated and delivered by a dedicated rehabilitation practitioner .", "The Rivermead Mobility Index ( RMI ) ( range 0-15 ) at 3 months ; higher scores indicate greater mobility .", "Secondary outcomes included HRQOL , psychological outcomes , self-reported symptoms , patient experience , and cost-effectiveness during a 12-month follow-up ( completed in February 2014 ) .", "Median RMI at randomization was 3 ( interquartile range [ IQR ] , 1-6 ) and at 3 months was 13 ( IQR , 10-14 ) for the intervention and usual care groups ( mean difference , -0.2 [ 95 % CI , -1.3 to 0.9 ; P = .71 ] ) .", "The HRQOL scores were unchanged by the intervention ( mean difference in the Physical Component Summary score , -0.1 [ 95 % CI , -3.3 to 3.1 ; P = .96 ] ; and in the Mental Component Summary score , 0.2 [ 95 % CI , -3.4 to 3.8 ; P = .91 ] ) .", "No differences were found for self-reported symptoms of fatigue , pain , appetite , joint stiffness , or breathlessness .", "Levels of anxiety , depression , and posttraumatic stress were similar , as were hand grip strength and the timed Up & Go test .", "No differences were found at the 6 - or 12-month follow-up for any outcome measures .", "However , patients in the intervention group reported greater satisfaction with physiotherapy , nutritional support , coordination of care , and information provision .", "Post-ICU hospital-based rehabilitation , including increased physical and nutritional therapy plus information provision , did not improve physical recovery or HRQOL , but improved patient satisfaction with many aspects of recovery .", "isrctn.com Identifier : ISRCTN09412438 ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "The aim of this study was to assess the relationship between sex and clinical outcomes and treatment-related complications in patients with ST-elevation or non-ST-elevation acute coronary syndromes ( ACS ) randomized to treatment with ticagrelor or clopidogrel in the PLATelet inhibition and patient Outcomes ( PLATO ) trial .", "The associations between sex subgroup and the primary composite outcomes , secondary outcomes , and major bleeding endpoints as well as interaction of sex subgroup with treatment effects were analysed using Cox proportional-hazards models .", "Sex was not significantly associated with the probability of the primary composite endpoint [ adjusted hazard ratio ( HR ) : 1.02 ( 0.91-1 .16 ) ] , or other adverse cardiovascular endpoints .", "Ticagrelor was similarly more effective than clopidogrel in reducing rates of the primary endpoint in women 11.2 vs. 13.2 % [ adjusted HR : 0.88 ( 0.74-1 .06 ) ] and men 9.4 vs. 11.1 % [ adjusted HR : 0.86 ( 0.76-0 .97 ) ] ( interaction P-value 0.78 ) , all-cause death in women 5.8 vs. 6.8 % [ adjusted HR : 0.90 ( 0.69-1 .16 ) ] and men 4.0 vs. 5.7 % [ adjusted HR : 0.80 ( 0.67-0 .96 ) ] ( interaction P-value 0.49 ) , and definite stent thrombosis in women 1.2 vs. 1.4 % [ adjusted HR : 0.71 ( 0.36-1 .38 ) ] and men 1.4 vs. 2.1 % [ adjusted HR : 0.63 ( 0.45-0 .89 ) ] ( interaction P-value 0.78 ) .", "The treatments did not differ for PLATO-defined overall major bleeding complications in women [ adjusted HR : 1.01 ( 0.83-1 .23 ) ] or men [ adjusted HR : 1.10 ( 0.98-1 .24 ) ] .", "Sex had no significant association with these outcomes ( interactions P = 0.43-0 .88 ) .", "Female sex is not an independent risk factor for adverse clinical outcomes in moderate-to-high risk ACS patients .", "Ticagrelor has a similar efficacy and safety profile in men and women ." ]

[ "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Pulmonary rehabilitation is effective for patients with COPD , but its benefit is less clearly established in idiopathic pulmonary fibrosis ( IPF ) , especially in regard to levels of physical activity and health-related quality of life .", "The objectives were to determine whether pulmonary rehabilitation increased physical activity as assessed by the International Physical Activity Questionnaire ( IPAQ ) , and improved quality of life and symptoms as assessed by the St George respiratory questionnaire for IPF ( SGRQ-I ) and the Borg dyspnea index ( BDI ) .", "Subjects who met current criteria for IPF were randomized to a 3-month pulmonary rehabilitation program ( n = 11 ) or to a control group ( n = 10 ) .", "The rehabilitation group participated in twice-weekly , 90-min exercise sessions ( 24 total sessions ) .", "The control group maintained its preceding , normal physical activity .", "All subjects underwent 6-min walk tests to assess the postexertion BDI .", "The SGRQ-I and a 5-point self-assessment of health were completed at baseline , after 3 months of intervention or observation , and after 3-month follow-up .", "All subjects completed the IPAQ weekly .", "Subjects in the rehabilitation group maintained significantly higher levels of physical activity throughout the 3-month rehabilitation program ( rehabilitation : 51,364 57,713 [ mean SD ] metabolic equivalent of task-minutes ; control : 20,832 37,155 , P = .027 by 2-tailed Mann-Whitney test ) .", "SGRQ-I symptom domain scores improved considerably by -9 22 in the rehabilitation group , whereas in the control group they worsened ( 16 12 rehabilitation compared with control , P = .013 by 2-tailed Mann-Whitney test ) .", "During the 3-month follow-up , self-reported physical activity levels in the rehabilitation group were 14,428 8,884 metabolic equivalent of task-minutes and in the control group 16,923 32,620 ( P = .17 by 2-tailed Mann-Whitney test ) , demonstrating substantial reversal of activity in the rehabilitation group .", "BDI scores after 6-min walk tests did not change significantly .", "A 3-month rehabilitation program significantly improved symptoms ( SGRQ-I ) and physical activity levels ( IPAQ ) in subjects with IPF while they participated actively in the program .", "( ClinicalTrials.gov registration NCT01118221 . )" ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To compare total laparoscopic hysterectomy ( TLH ) , total abdominal hysterectomy ( TAH ) and vaginal hysterectomy ( VH ) using electrosurgical bipolar vessel sealing ( EBVS ) technique regarding operative time , intra and postoperative complications .", "The current prospective randomized controlled clinical trial was conducted at Ain-shams University maternity Hospital , Cairo , Egypt .", "Ninety patients who were admitted from gynecologic outpatient clinic to undergo hysterectomy were enrolled .", "The study population was randomized according to type of hysterectomy done into 3 groups : group 1 : VH ; group 2 : AH and group 3 : TLH .", "EBVS was used in all groups .", "Three staff members ' surgeons were also randomized to operate on the patients and they were all equally competent in all the procedures .", "Main outcome measures were operative time , operative blood loss , operative complications , postoperative pain assessment using the visual analogue scale ( 0-10 ) , and the need for analgesics as well as the postoperative hospital stay .", "Ninety patients were randomized to undergo VH , TAH or TLH for benign pathology using EBVS .", "Postoperative pain score and the need for analgesia were least in TLH compared to the other two groups , ( p < 0.001 ) .", "The hospital stay in TLH group was shorter than the other two groups , but there was no significant difference between VH group and TAH group with regard to hospital stay , ( p < 0.001 ) .", "The total operative time was shortest in the VH group ( 100.4 35.8 min ) compared to TLH ( 126 42.7 min ) and TAH ( 123.6 44.5 min ) ( p = 0.033 ) .", "The operative complications were more with VH and TAH groups .", "The blood loss was more with VH ( p = 0.039 ) .", "TLH had a longer operation time , yet , less blood loss , shorter hospital stay , less postoperative pain and fewer complications , compared to TAH and VH using EBVS ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Fibroblast growth factor 23 ( FGF23 ) is a hormone that regulates phosphorus and vitamin D metabolism .", "Elevated FGF23 concentrations are associated with excess risk of cardiovascular disease .", "Associations of FGF23 with stroke outcomes are less clear .", "Using a case-cohort study design , we examined the association of baseline plasma FGF23 concentrations with incident stroke in the Reasons for Geographic and Racial Differences in Stroke ( REGARDS ) study , a cohort of black and white adults aged 45 years .", "FGF23 was measured in 615 participants who developed incident stroke ( cases ) and in 936 participants randomly selected from the REGARDS cohort ( comparison subcohort ) .", "In multivariable-adjusted models , higher calcium and phosphorus concentrations , lower estimated glomerular filtration rate and higher urine albumin excretion were independently associated with higher FGF23 .", "There was no statistically significant association of FGF23 with risk of all-cause stroke in Cox models adjusted for demographic factors and established stroke risk factors ( hazard ratio comparing fourth with first quartile 1.19 ; 95 % confidence interval , 0.78-1 .82 ) .", "In prespecified models stratified by stroke subtypes , there was a graded association of FGF23 with risk of cardioembolic stroke in fully adjusted models ( quartile 1 , reference ; quartile 2 hazard ratio , 1.48 ; 95 % confidence interval , 0.63-3 .47 ; quartile 3 hazard ratio , 1.99 ; 95 % confidence interval , 0.89-4 .44 ; quartile 4 hazard ratio , 2.52 ; 95 % confidence interval , 1.08-5 .91 ) .", "There were no statistically significant associations of FGF23 with other ischemic stroke subtypes or with hemorrhagic strokes .", "Higher FGF23 concentrations were associated with higher risk of cardioembolic but not with other stroke subtypes in community-dwelling adults .", "Additional studies should delineate reasons for these findings ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "In patients undergoing regadenoson stress SPECT myocardial perfusion imaging ( MPI ) , the impact of the regimented administration of aminophylline on the cardiac-to-extracardiac photon activity ratio is unknown .", "This is a substudy of the ASSUAGE trial ( NCT01250496 ) ; a double-blinded , randomized , placebo-controlled clinical trial which investigated the attenuation of regadenoson-related adverse effects using 75 mg of intravenous aminophylline vs placebo , administered 90 seconds following ( 99m ) Tc-tetrofosmin injection in patients undergoing regadenoson stress SPECT-MPI .", "In subjects with normal MPI enrolled in the trial , we sampled from the antero-posterior planar projection of the post-stress scintigraphic data the mean photon activity in the myocardium , liver , bowel , and lungs .", "The mean cardiac-to-extracardiac activity ratios were compared between patients randomized to aminophylline vs placebo .", "We studied 158 eligible subjects , randomized to receive aminophylline ( n = 86 ) or placebo ( n = 72 ) .", "The means of photon activity ratios of the heart-to-liver , heart-to-bowel , heart-to-lungs , inferior wall of the heart-to-liver , and inferior wall of the heart-to-bowel were not statistically different between those who received aminophylline vs placebo ( P values > .30 ) .", "Only the time lapse between stress ( 99m ) Tc-tetrofosmin injection and stress SPECT acquisition independently correlated with higher heart-to-liver and heart-to-bowel activity ratios ( P values .01 ) .", "Patients ' body mass index independently correlated with lower heart-to-lung ratio ( P = .009 ) .", "The regimented intravenous aminophylline use following regadenoson stress does not significantly improve the cardiac-to-extracardiac photon activity ratio in patients undergoing regadenoson stress ( 99m ) Tc-tetrofosmin SPECT-MPI ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Physical inactivity is fourth in the list of risk factors for global mortality .", "General practitioners are well placed to offer physical activity counseling but insufficient time is a barrier .", "Although referral to an exercise specialist is an alternative , in Australia , these allied health professionals are only publicly funded to provide face-to-face counseling to patients who have an existing chronic illness .", "Accordingly , this trial aims to determine the efficacy of GP referral of insufficiently active patients ( regardless of their chronic disease status ) for physical activity counseling ( either face-to-face or predominately via telephone ) by exercise specialists , based on patients ' objectively assessed physical activity levels , compared with usual care .", "If the trial is efficacious , the equivalence and cost-effectiveness of face-to-face counseling versus telephone counseling will be assessed .", "This three arm pragmatic randomized trial will involve the recruitment of 261 patients from primary care clinics in metropolitan and regional areas of New South Wales , Australia .", "Insufficiently active ( less than 7000 steps/day ) consenting adult patients will be randomly assigned to : 1 ) five face-to-face counseling sessions , 2 ) one face-to-face counseling session followed by four telephone calls , or 3 ) a generic mailed physical activity brochure ( usual care ) .", "The interventions will operationalize social cognitive theory via a behavior change counseling framework .", "Participants will complete a survey and seven days of pedometry at baseline , and at three and 12 months post-randomization .", "The primary analyses will be based on intention-to-treat principles and will compare : ( i ) mean change in average daily step counts between baseline and 12 months for the combined intervention group ( Group 1 : face-to-face , and Group 2 : telephone ) and usual care ( Group 3 ) ; ( ii ) step counts at 3 months post-randomization .", "Secondary outcomes include : self-reported physical activity , sedentary behavior , quality of life , and depression .", "If referral of primary care patients to exercise specialists increases physical activity , this process offers the prospect of systematically and sustainably reaching a large proportion of insufficiently active adults .", "If shown to be efficacious this trial provides evidence to expand public funding beyond those with a chronic disease and for delivery via telephone as well as face-to-face consultations .", "Australian New Zealand Clinical Trials Registry ACTRN12611000884909 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Untreated advanced hepatocellular carcinoma ( HCC ) is linked to poor prognosis .", "While sorafenib is the current recommended treatment for advanced HCC , radioembolisation ( RE ; also called selective internal radiation therapy or SIRT ) with yttrium-90 microspheres has shown efficacy in cohort studies .", "However , there are no head-to-head trials comparing radiation therapy with yttrium-90 microspheres and sorafenib in advanced HCC .", "The SARAH trial has been designed to compare the efficacy and safety of sorafenib therapy and RE using yttrium-90 resin microspheres ( SIR-Spheres ; Sirtex Medical Limited , North Sydney , Australia ) in patients with advanced HCC .", "Quality of life ( QoL ) and cost-effectiveness will also be compared between therapies .", "SARAH is a prospective , randomised , controlled , open-label , multicentre trial comparing the efficacy of RE with sorafenib in the treatment of patients with advanced HCC .", "The trial aims to recruit adults with a life expectancy of > 3 months , Eastern Cooperative Oncology Group ( ECOG ) performance status 1 , and : advanced HCC according to the Barcelona criteria ( stage C ) or recurrent HCC after surgical or thermoablative treatment who are not eligible for surgical resection , liver transplantation or thermal ablation ; or two rounds of failed chemoembolisation .", "Patients will be randomised 1:1 to receive either RE or sorafenib 400 mg twice daily .", "All patients will be monitored for between 12 and 48 months following start of treatment .", "The primary endpoint of the SARAH trial is overall survival ( OS ) .", "Secondary endpoints include : adverse events , progression-free survival at 6 months ; tumour response rate ; general or liver disease-specific QoL scores ; and cost of each treatment strategy .", "Assuming an increase in median OS of 4 months with RE versus sorafenib therapy , randomising at least 400 patients ( 200 in each treatment arm ) will be sufficient for 80 % power and a bilateral alpha risk of 5 % ; therefore , 440 patients will be enrolled to allow for 10 % loss of patients due to ineligibility .", "The SARAH trial is the first randomised head-to-head study to compare RE with sorafenib in advanced HCC , and will establish the potential role of RE in HCC treatment guidelines .", "ClinicalTrials.gov identifier NCT01482442 , first received 28 November 2011 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND" ]

[ "To compare the safety and efficacy of combined therapy using sildenafil and tamsulosin for management of acute urinary retention ( AUR ) with tamsulosin alone in patients with benign prostate hyperplasia ( BPH ) .", "101 patients were enrolled in a randomized placebo-controlled study from June 2009 to April 2012 .", "Patients presenting with an initial episode of spontaneous AUR underwent urethral catheterization and then prospectively randomized to receive tamsulosin 0.4 mg plus sildenafil 50mg in group A and tamsulosin 0.4 mg plus placebo in group B for three days .", "Urethral catheter was removed three days after medical treatment and patient 's ability to void assessed at the day after catheter removal and seven days later .", "Patients who voided successfully were followed at least for three months .", "Mean age of patients was 59.64 3.84 years in group A and 60.56 4.12 years in group B ( p value = 0.92 ) .", "Mean prostate volume and mean residual urine were comparable between both groups ( p value = 0.74 and 0.42 , respectively ) .", "Fifteen patients in group A ( success rate : 70 % ) and nineteen patients in group B ( success rate : 62.7 % ) had failed trial without catheter ( TWOC ) at 7th day following AUR ( p value = 0.3 ) .", "No significant difference was noted between both groups regarding the rate of repeated AUR at one month and three month follow-up period ( p = 0.07 and p = 0.45 , respectively ) .", "It seems that combination therapy by using 5-phosphodiesterase inhibitor and tamsulosin has no significant advantages to improve urinary retention versus tamsulosin alone ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Auto-Disable syringes are recommended for immunization because of their greater safety and preventing reuse .", "In this study , the role of the syringe and needle gauge on the adverse events following Diphtheria , Tetanus toxoids and whole-cell Pertussis immunization was studied .", "In this study , 1000 children from 2 months to 6 years of age , eligible for Diphtheria , Tetanus toxoids and whole-cell Pertussis immunization and who referred to 4 health centers , were randomized into 2 groups of regular syringe users ( the Auto-Disable syringe with a 23 gauge and 25 mm needle ) and new syringe users ( the disposable syringe with a 24 gauge and 25 mm needle ) .", "Adverse events following immunization were evaluated on days 2 , 4 and 6 after immunization by visiting the children at their home and examining them .", "The occurrence of the primary endpoint ( severe local reaction ) was found to be 2.1 % in all the children , 2.0 % in the children vaccinated with the Auto-Disable syringe and 2.2 % in the children vaccinated with the new syringe .", "This difference is not significant ( P = 0.818 ) .", "The evaluation of other milder adverse events ( secondary endpoints ) showed that the syringe type has no effect on the occurrence of these adverse events .", "Syringe types and needle diameter played no role in precipitating the adverse events following immunization of the Diphtheria , Tetanus toxoids and whole-cell Pertussis vaccine ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To compare the long-term clinical and radiologic outcomes of temporomandibular joint osteoarthritis ( TMJ-OA ) treated with arthrocentesis plus platelet-rich plasma ( PRP ) versus arthrocentesis alone .", "A randomized clinical trial in adult patients with TMJ-OA referred to the authors ' clinic from May 2012 through July 2013 was implemented .", "The sample was composed of 30 consecutive patients with TMJ-OA treated randomly with arthrocentesis alone ( control group ) or initial arthrocentesis plus PRP injection and then 4 consecutive PRP injections ( study group ) .", "The predictor variable was treatment technique .", "The outcome variables were visual analog scale evaluations ( masticatory efficiency , joint sounds , and pain complaints ) , maximal interincisal opening , and cone-beam computed tomographic ( CBCT ) findings .", "Outcome variables were recorded preoperatively and 12 months postoperatively .", "Descriptive and bivariate statistics were computed , and significance was set at a P value less than .05 .", "The paired t and Student t tests were used for intragroup and intergroup comparisons , respectively .", "The sample was composed of 47 joints of 30 patients with OA ( control group : 15 joints of 12 patients ; mean age , 35.08 14.84 yr ; study group : 32 joints of 18 patients ; mean age , 32.22 14.32 yr ) .", "Joint sounds and general pain complaints decreased statistically in the 2 groups , whereas masticatory efficiency , painless interincisal opening , and lateral motion increased statistically only in the study group .", "However , only masticatory efficiency showed statistically greater improvement in the study group compared with the control group .", "CBCT evaluations showed that reparative remodeling of the osseous abnormalities occurred at rates of 87.5 and 46.6 % in the study and control groups , respectively .", "These findings suggested that arthrocentesis and PRP injections constitute a safe and promising method for the treatment of TMJ-OA that is superior to arthrocentesis alone ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Cerebral palsy is the most common cause of physical disability in childhood .", "Spasticity is a significant contributor to the secondary impairments impacting functional performance and participation .", "The most common lower limb spasticity management is focal intramuscular injections of Botulinum Toxin-Type A accompanied by individually-delivered ( one on one ) physiotherapy rehabilitation .", "With increasing emphasis on improving goal-directed functional activity and participation within a family-centred framework , it is timely to explore whether physiotherapy provided in a group could achieve comparable outcomes , encouraging providers to offer flexible models of physiotherapy delivery .", "This study aims to compare individual to group-based physiotherapy following intramuscular Botulinum Toxin-A injections to the lower limbs for ambulant children with cerebral palsy aged four to fourteen years .", "An assessor-masked , block randomised comparison trial will be conducted with random allocation to either group-based or individual physiotherapy .", "A sample size of 30 ( 15 in each study arm ) will be recruited .", "Both groups will receive six hours of direct therapy following Botulinum Toxin-A injections in either an individual or group format with additional home programme activities ( three exercises to be performed three times a week ) .", "Study groups will be compared at baseline ( T1 ) , then at 10 weeks ( T2 , efficacy ) and 26 weeks ( T3 , retention ) post Botulinum Toxin-A injections .", "Primary outcomes will be caregiver/s perception of and satisfaction with their child 's occupational performance goals ( Canadian Occupational Performance Measure ) and quality of gait ( Edinburgh Visual Gait Score ) with a range of secondary outcomes across domains of the International Classification of Disability , Functioning and Health .", "This paper outlines the study protocol including theoretical basis , study hypotheses and outcome measures for this assessor-masked , randomised comparison trial comparing group versus individual models of physiotherapy following intramuscular injections of Botulinum Toxin-A to the lower limbs for ambulant children with cerebral palsy .", "ACTRN12611000454976 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND" ]

[ "Amino acids are well known to be key effectors of gut protein turnover .", "We recently reported that enteral delivery of proteins markedly stimulated global duodenal protein synthesis in carbohydrate-fed healthy humans , but specifically affected proteins remain unknown .", "We aimed to assess the influence of an enteral protein supply on the duodenal mucosal proteome in carbohydrate-fed humans .", "Six healthy volunteers received for 5 h , on 2 occasions and in random order , either an enteral infusion of maltodextrins alone ( 0.25 g kg h ) mimicking the fed state or maltodextrins with a protein powder ( 0.14 g proteins kg h ) .", "Endoscopic duodenal biopsy specimens were then collected and frozen until analysis .", "A 2-dimensional polyacrylamide gel electrophoresis-based comparative proteomics analysis was then performed , and differentially expressed proteins ( at least 1.5-fold change ; Student 's t test , P < 0.05 ) were identified by mass spectrometry .", "Protein expression changes were confirmed by Western blot analysis .", "Thirty-two protein spots were differentially expressed after protein delivery compared with maltodextrins alone : 28 and 4 spots were up - or downregulated , respectively .", "Among the 22 identified proteins , 11 upregulated proteins were involved either in the cytoskeleton ( ezrin , moesin , plastin 1 , lamin B1 , vimentin , and - actin ) or in protein biosynthesis ( glutamyl-prolyl-transfer RNA synthetase , glutaminyl-transfer RNA synthetase , elongation factor 2 , elongation factor 1 , and eukaryotic translation and initiation factor 3 subunit f ) .", "Enteral delivery of proteins altered the duodenal mucosal proteome and mainly stimulated the expression of proteins involved in cytoskeleton and protein biosynthesis .", "These results suggest that protein supply may affect intestinal morphology by stimulating actin cytoskeleton remodeling ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Physical activity ( PA ) and nutrition are the cornerstones of diabetes management .", "Several reviews and meta-analyses report that PA independently produces clinically important improvements in glucose control in people with Type 2 diabetes .", "However , it remains unclear what the optimal strategies are to increase PA behaviour in people with Type 2 diabetes in routine primary care .", "This study will determine whether an evidence-informed multifaceted behaviour change intervention ( Movement as Medicine for Type 2 Diabetes ) targeting both consultation behaviour of primary healthcare professionals and PA behaviour in adults with Type 2 diabetes is both acceptable and feasible in the primary care setting .", "An open pilot study conducted in two primary care practices ( phase one ) will assess acceptability , feasibility and fidelity .", "Ongoing feedback from participating primary healthcare professionals and patients will provide opportunities for systematic adaptation and refinement of the intervention and study procedures .", "A two-arm parallel group clustered pilot randomised controlled trial with patients from participating primary care practices in North East England will assess acceptability , feasibility , and fidelity of the intervention ( versus usual clinical care ) and trial processes over a 12-month period .", "Consultation behaviour involving fidelity of intervention delivery , diabetes and PA related knowledge , attitudes/beliefs , intentions and self-efficacy for delivering a behaviour change intervention targeting PA behaviour will be assessed in primary healthcare professionals .", "We will rehearse the collection of outcome data ( with the focus on data yield and quality ) for a future definitive trial , through outcome assessment at baseline , one , six and twelve months .", "An embedded qualitative process evaluation and treatment fidelity assessment will explore issues around intervention implementation and assess whether intervention components can be reliably and faithfully delivered in routine primary care .", "Movement as Medicine for Type 2 Diabetes will address an important gap in the evidence-base , that is , the need for interventions to increase free-living PA behaviour in adults with Type 2 diabetes .", "The multifaceted intervention incorporates an online accredited training programme for primary healthcare professionals and represents , to the best of our knowledge , the first of its kind in the United Kingdom .", "This study will establish whether the multifaceted behavioural intervention is acceptable and feasible in routine primary care .", "Movement as Medicine for Type 2 Diabetes ( MaMT2D ) was registered with Current Controlled Trials on the 14th January 2012 : ISRCTN67997502 .", "The first primary care practice was randomised on the 5th October 2012 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "Dengue shock syndrome ( DSS ) fluid resuscitation by following the World Health Organization ( WHO ) guideline usually required large volumes of Ringer lactate ( RL ) that might induce secondary fluid overload .", "Our objective was to compare the effectiveness of the recommended volume of RL versus a smaller volume of a hypertonic sodium lactate solution ( HSL ) in children with DSS .", "The primary end point was to evaluate the effect of HSL on endothelial cell inflammation , assessed by soluble vascular cell adhesion molecule-1 ( sVCAM-1 ) measurements .", "Secondarily , we considered the effectiveness of HSL in restoring hemodynamic fluid balance , acid-base status , and sodium and chloride balances , as well as in-hospital survival .", "A prospective randomized single-blind clinical trial including 50 DSS children was conducted in the Pediatrics Department of Hasan Sadikin Hospital , Bandung , Indonesia .", "Only pediatric patients ( 2 to 14 years old ) fulfilling the WHO criteria for DSS and new to resuscitation treatments were eligible .", "Patients were resuscitated with either HSL ( 5 ml/kg/BW in 15 minutes followed by 1 ml/kg/BW / h for 12 hours ) , or RL ( 20 ml/kg/BW in 15 minutes followed by decreasing doses of 10 , 7 , 5 , and 3 ml/kg BW/h for 12 hours ) .", "In total , 50 patients were randomized and included in outcome and adverse-event analysis ; 46 patients ( 8.20.5 years ; 24.91.9 kg ; meanSEM ) completed the protocol and were fully analyzed ( 24 and 22 subjects in the HSL and RL groups , respectively ) .", "Baseline ( prebolus ) data were similar in both groups .", "Hemodynamic recovery , plasma expansion , clinical outcome , and survival rate were not significantly different in the two groups , whereas fluid accumulation was one third lower in the HSL than in the RL group .", "Moreover , HSL was responsible for a partial recovery from endothelial dysfunction , as indicated by the significant decrease in sVCAM-1 .", "Similar hemodynamic shock recovery and plasma expansion were achieved in both groups despite much lower fluid intake and fluid accumulation in the HSL group .", "ClinicalTrials.gov NCT00966628 .", "Registered 26 August 2009 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "`` Nudges '' that influence decision making through subtle cognitive mechanisms have been shown to be highly effective in a wide range of applications , but there have been few experiments to improve clinical practice .", "To investigate the use of a behavioral `` nudge '' based on the principle of public commitment in encouraging the judicious use of antibiotics for acute respiratory infections ( ARIs ) .", "Randomized clinical trial in 5 outpatient primary care clinics .", "A total of 954 adults had ARI visits during the study timeframe : 449 patients were treated by clinicians randomized to the posted commitment letter ( 335 in the baseline period , 114 in the intervention period ) ; 505 patients were treated by clinicians randomized to standard practice control ( 384 baseline , 121 intervention ) .", "The intervention consisted of displaying poster-sized commitment letters in examination rooms for 12 weeks .", "These letters , featuring clinician photographs and signatures , stated their commitment to avoid inappropriate antibiotic prescribing for ARIs .", "Antibiotic prescribing rates for antibiotic-inappropriate ARI diagnoses in baseline and intervention periods , adjusted for patient age , sex , and insurance status .", "Baseline rates were 43.5 % and 42.8 % for control and poster , respectively .", "During the intervention period , inappropriate prescribing rates increased to 52.7 % for controls but decreased to 33.7 % in the posted commitment letter condition .", "Controlling for baseline prescribing rates , we found that the posted commitment letter resulted in a 19.7 absolute percentage reduction in inappropriate antibiotic prescribing rate relative to control ( P = .02 ) .", "There was no evidence of diagnostic coding shift , and rates of appropriate antibiotic prescriptions did not diminish over time .", "Displaying poster-sized commitment letters in examination rooms decreased inappropriate antibiotic prescribing for ARIs .", "The effect of this simple , low-cost intervention is comparable in magnitude to costlier , more intensive quality-improvement efforts .", "clinicaltrials.gov identifier : NCT01767064 ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Blood loss after cardiac surgery can be caused by impaired platelet ( PLT ) function after cardiopulmonary bypass .", "Desmopressin or 1-deamino-8-D-arginine vasopressin ( DDAVP ) is a synthetic analog of vasopressin .", "DDAVP can increase the level of von Willebrand factor and coagulation factor VIII , thus it may enhance PLT function and improve coagulation .", "In this study , we assessed the effects of DDAVP on PLT aggregation and blood loss in patients undergoing cardiac surgery .", "A total of 102 patients undergoing valvular heart surgery ( from October 2010 to June 2011 ) were divided into DDAVP group ( n = 52 ) and control group ( n = 50 ) .", "A dose of DDAVP ( 0.3 g/kg ) was administered to the patients intravenously when they were being re-warmed .", "At the same time , an equal volume of saline was given to the patients in the control group .", "PLT aggregation rate was measured with the AggRAM four-way PLT aggregation measurement instrument .", "The blood loss and transfusion , hemoglobin levels , PLT counts , and urine outputs at different time were recorded and compared .", "The postoperative blood loss in the first 6 h was significantly reduced in DDAVP group ( 202 119 ml vs. 258 143 ml , P = 0.023 ) .", "The incidence of fresh frozen plasma ( FFP ) transfusion was decreased postoperatively in DDAVP group ( 3.8 % vs. 12 % , P = 0.015 ) .", "There was no significant difference in the PLT aggregation , urine volumes , red blood cell transfusions and blood loss after 24 h between two groups .", "A single dose of DDAVP can reduce the first 6 h blood loss and FFP transfusion postoperatively in patients undergoing valvular heart surgery , but has no effect on PLT aggregation ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Combined BRAF and MEK inhibition , as compared with BRAF inhibition alone , delays the emergence of resistance and reduces toxic effects in patients who have melanoma with BRAF V600E or V600K mutations .", "In this phase 3 trial , we randomly assigned 423 previously untreated patients who had unresectable stage IIIC or stage IV melanoma with a BRAF V600E or V600K mutation to receive a combination of dabrafenib ( 150 mg orally twice daily ) and trametinib ( 2 mg orally once daily ) or dabrafenib and placebo .", "The primary end point was progression-free survival .", "Secondary end points included overall survival , response rate , response duration , and safety .", "A preplanned interim overall survival analysis was conducted .", "The median progression-free survival was 9.3 months in the dabrafenib-trametinib group and 8.8 months in the dabrafenib-only group ( hazard ratio for progression or death in the dabrafenib-trametinib group , 0.75 ; 95 % confidence interval [ CI ] , 0.57 to 0.99 ; P = 0.03 ) .", "The overall response rate was 67 % in the dabrafenib-trametinib group and 51 % in the dabrafenib-only group ( P = 0.002 ) .", "At 6 months , the interim overall survival rate was 93 % with dabrafenib-trametinib and 85 % with dabrafenib alone ( hazard ratio for death , 0.63 ; 95 % CI , 0.42 to 0.94 ; P = 0.02 ) .", "However , a specified efficacy-stopping boundary ( two-sided P = 0.00028 ) was not crossed .", "Rates of adverse events were similar in the two groups , although more dose modifications occurred in the dabrafenib-trametinib group .", "The rate of cutaneous squamous-cell carcinoma was lower in the dabrafenib-trametinib group than in the dabrafenib-only group ( 2 % vs. 9 % ) , whereas pyrexia occurred in more patients ( 51 % vs. 28 % ) and was more often severe ( grade 3 , 6 % vs. 2 % ) in the dabrafenib-trametinib group .", "A combination of dabrafenib and trametinib , as compared with dabrafenib alone , improved the rate of progression-free survival in previously untreated patients who had metastatic melanoma with BRAF V600E or V600K mutations .", "( Funded by GlaxoSmithKline ; Clinical Trials.gov number , NCT01584648 . )" ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To compare the efficacy and safety between tension-free vaginal tape obturator technique ( TVT-O ) and TVT-O with biofeedback pelvic floor electrical stimulation on the therapy of female stress urinary incontinence .", "In this prospective study , 120 female patients of female stress urinary incontinence were enrolled from January 2012 to December 2013 .", "The patients were randomly assigned to two groups , 60 in group A received TVT-O alone , while 60 in group B not only received TVT-O but also received biofeedback pelvic floor electrical stimulation .", "All the patients were followed up for 12 months to assess the efficacy and safety of the two procedures .", "Subjective indices [ total volume of urine ( TV ) , the total frequency of urination ( TOV ) , the total leakage of urine events ( TL ) , urinary incontinence related quality of life questionnaire ( I-QOL ) , International Advisory Committee on urinary incontinence urinary incontinence questionnaire short form scale ( ICI-Q-SF ) ] and objective indices [ Valsalva leak point pressure ( VLPP ) , maximum flow rate ( MFR ) , residual urine volume ( RUV ) , pad test ] were analyzed .", "Overall , the cure rate was 75 % at 1 year follow-up for group A and 88.33 % for group B ( P < 0.05 ) .", "The effective rate was 16.67 % for group A and 10 % for group B ( P < 0.05 ) .", "The ineffective rate was 8.33 % for group A and 1.67 % for group B ( P < 0.05 ) .", "TV , I-QOL , ICI-Q-SF , VLPP and pad test in group B were superior to group A ( P < 0.05 ) .", "Pelvic floor electrical stimulation biofeedback therapy could improve the curative effects of TVT-O on the treatment of female stress urinary incontinence ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "The hypothesis that covered stents are superior to bare-metal stents ( BMS ) in long femoropopliteal artery disease was tested .", "The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol ( TPP ) analysis only .", "A prospective , randomized , single-blind , multicenter study evaluated 141 patients with symptomatic peripheral arterial disease ( PAD ) after treatment with heparin-bonded covered stents ( VIABAHN ( ) Endoprosthesis ) or BMS .", "Clinical outcomes and patency rates were assessed at 1 , 6 , 12 , and 24 months .", "Mean lesion length was 19.0 6.3 cm in the VIABAHN ( ) versus 17.3 6.6 cm in the BMS group .", "The 24-month primary patency rates in the VIABAHN ( ) and BMS group were : intention-to-treat 63.1 ( 95 % CI 0.52-0 .76 ) versus 41.2 % ( 95 % CI 0.29-0 .57 ; log rank p = 0.04 ) and TPP 69.4 ( 95 % CI 0.58-0 .83 ) versus 40.0 % ( 95 % CI 0.28-0 .56 ; log rank p = 0.004 ) .", "Freedom from target-lesion-revascularization ( TLR ) was 79.4 ( 95 % CI 0.70-0 .90 ) versus 73.0 % ( 95 % CI 0.63-0 .85 ) for VIABAHN ( ) versus BMS ( log rank p = 0.37 ) .", "For the TPP group in lesions 20 cm , the 24-month patency rates were 65.2 ( 95 % CI 0.50-0 .85 ) versus 26.7 % ( 95 % CI 0.12-0 .59 ; log rank p = 0.004 ) for VIABAHN ( ) versus BMS , and freedom from TLR was 80.0 ( 95 % CI 0.68-0 .94 ) versus 61.9 % ( 95 % CI 0.44-0 .87 ; log rank p = 0.13 ) .", "The ankle brachial index was 0.89 0.18 versus 0.91 0.17 ( p = 0.76 ) at 24-month in the VIABAHN ( ) versus the BMS group , respectively .", "At 24-month , this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS , however , without a significant impact on clinical outcomes and TLR rate ( Reg .", "Nr .", "ISRCTN48164244 ) ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The treat-to-target ( T2T ) approach to the care of patients with rheumatoid arthritis involves using validated metrics to measure disease activity , frequent follow-up visits for patients with moderate to high disease activity , and escalation of therapy when patients have inadequate therapeutic response as assessed by standard disease activity scores .", "The study described is a newly launched cluster-randomized behavioral intervention to assess the feasibility and effectiveness of the T2T approach in US rheumatology practices .", "It is designed to identify patient and provider barriers to implementing T2T management .", "This initial paper focuses on the novel study design and methods created to provide these insights .", "This trial cluster-randomizes rheumatology practices from the existing Corrona network of private and academic sites rather than patients within sites or individual investigators to provide either T2T or usual care ( UC ) for qualified patients who meet the 2010 revised American College of Rheumatology criteria for the diagnosis of rheumatoid arthritis and have moderate to high disease activity .", "Specific medication choices are left to the investigator and patient , rather than being specified in the protocol .", "Enrollment is expected to be completed by the end of 2013 , with 30 practices randomized and enrolling a minimum of 530 patients .", "During the 12-month follow-up , visits are mandated as frequently as monthly in patients with active disease in the T2T group and every 3 months for the UC group .", "Safety data are collected at each visit .", "The coprimary endpoints include a comparison of the proportion of patients achieving low disease activity in the T2T and UC groups and assessment of the feasibility of implementing T2T in rheumatology practices , specifically assessment of the rates of treatment acceleration , frequency of visits , time to next visit conditional on disease activity , and probability of acceleration conditional on disease activity in the 2 groups .", "This cluster-randomized behavioral intervention study will provide valuable insights on the outcomes and feasibility of employing a T2T treatment approach in clinical practice in the United States .", "NCT01407419 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND" ]

[ "We developed and validated a simple algorithm to predict the risk of hematoma growth in acute spontaneous intracerebral hemorrhage ( ICH ) to better inform clinicians and researchers in their efforts to improve outcomes for patients .", "We analyzed data from the computed tomography substudies of the pilot and main phases of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials ( INTERACT1 and 2 , respectively ) .", "The study group was divided into a derivation cohort ( INTERACT2 , n = 964 ) and a validation cohort ( INTERACT1 , n = 346 ) .", "Multivariable logistic regression was used to identify factors associated with clinically significant ( 6 mL ) increase in hematoma volume at 24 hours after symptom onset .", "A parsimonious risk score was developed on the basis of regression coefficients derived from the logistic model .", "A 24-point BRAIN score was derived from INTERACT2 ( C-statistic , 0.73 ) based on baseline ICH volume ( mL per score , 10 = 0 , 10-20 = 5 , > 20 = 7 ) , recurrent ICH ( yes = 4 ) , anticoagulation with warfarin at symptom onset ( yes = 6 ) , intraventricular extension ( yes = 2 ) , and number of hours to baseline computed tomography from symptom onset ( 1 = 5 , 1-2 = 4 , 2-3 = 3 , 3-4 = 2 , 4-5 = 1 , > 5 = 0 ) predicted the probability of ICH growth ( ranging from 3.4 % for 0 point to 85.8 % for 24 points ) with good discrimination ( C-statistic , 0.73 ) and calibration ( Hosmer-Lemeshow P = 0.82 ) in INTERACT1 .", "The simple BRAIN score predicts the probability of hematoma growth in ICH .", "This could be used to improve risk stratification for research and clinical practice .", "http://www.clinicaltrials.gov .", "Unique identifier : NCT00226096 and NCT00716079 ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "The aim of this trial was to compare functional capacity , pulmonary shunt fraction and clinical outcomes between patients undergoing pleurotomy with a pleural drain inserted in the sub-xyphoid position and patients with a pleural drain placed in the intercostal position after off-pump coronary artery bypass surgery .", "Patients were randomized into two groups according to the pleural drain site : Group II ( n = 33 intercostal pleural drain ) ; and Group SI ( n = 35 sub-xyphoid pleural drain ) .", "Functional capacity was assessed by the distance covered on the 6-min walking test performed preoperatively and on postoperative day ( POD ) 5 ; in addition , pulmonary function test was determined preoperatively and on POD 1 and 5 .", "Pulmonary shunt fraction was evaluated preoperatively and on POD 1 , and clinical outcomes were recorded throughout the study .", "Group SI had better preservation of lung volumes and capacities in POD compared with Group II ( P < 0.05 ) .", "Pulmonary shunt fraction increased in both groups postoperatively ; however , Group SI showed a smaller pulmonary shunt fraction ( 0.26 0.04 vs 0.21 0.04 % ; P = 0.0014 ) .", "Functional capacity was significantly reduced in both groups on POD 5 ; however , Group SI showed better preservation of functional capacity ( P = 0.0001 ) .", "Group SI had better postoperative clinical results , with lower incidence of atelectasis and pleural effusion ( P < 0.05 ) , lower pain scores ( P < 0.0001 ) , and shorter orotracheal intubation and hospitalization lengths ( P < 0.001 ) .", "Sub-xyphoid pleural drain determined better functional capacity and exercise tolerance with a smaller pulmonary shunt fraction and improved clinical outcomes compared with intercostal pleural drainage after off-pump coronary artery bypass surgery ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Acute renal failure ( ARF ) requiring renal replacement therapy ( RRT ) occurs frequently in ICU patients and significantly affects mortality rates .", "Previously , few large clinical trials investigated the impact of RRT modalities on patient outcomes .", "Here we investigated the effect of two major RRT strategies ( intermittent hemodialysis ( IHD ) and continuous veno-venous hemofiltration ( CVVH ) ) on mortality and renal-related outcome measures .", "This single-center prospective randomized controlled trial ( `` CONVINT '' ) included 252 critically ill patients ( 159 male ; mean age , 61.513.9 years ; Acute Physiology and Chronic Health Evaluation ( APACHE ) II score , 28.68.8 ) with dialysis-dependent ARF treated in the ICUs of a tertiary care academic center .", "Patients were randomized to receive either daily IHD or CVVH .", "The primary outcome measure was survival at 14 days after the end of RRT .", "Secondary outcome measures included 30-day - , intensive care unit - , and intrahospital mortality , as well as course of disease severity/biomarkers and need for organ-support therapy .", "At baseline , no differences in disease severity , distributions of age and gender , or suspected reasons for acute renal failure were observed .", "Survival rates at 14 days after RRT were 39.5 % ( IHD ) versus 43.9 % ( CVVH ) ( odds ratio ( OR ) , 0.84 ; 95 % confidence interval ( CI ) , 0.49 to 1.41 ; P = 0.50 ) .", "14-day - , 30-day , and all-cause intrahospital mortality rates were not different between the two groups ( all P > 0.5 ) .", "No differences were observed in days on RRT , vasopressor days , days on ventilator , or ICU - / intrahospital length of stay .", "In a monocentric RCT , we observed no statistically significant differences between the investigated treatment modalities regarding mortality , renal-related outcome measures , or survival at 14 days after RRT .", "Our findings add to mounting data demonstrating that intermittent and continuous RRTs may be considered equivalent approaches for critically ill patients with dialysis-dependent acute renal failure .", "NCT01228123 , clinicaltrials.gov ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Routine use of pulse oximetry has been associated with changes in bronchiolitis management and may have lowered the hospitalization threshold for patients with bronchiolitis .", "To examine if infants with bronchiolitis whose displayed oximetry measurements have been artificially elevated 3 percentage points above true values experience hospitalization rates at least 15 % lower compared with infants with true values displayed .", "Randomized , double-blind , parallel-group trial conducted from 2008 to 2013 in a tertiary-care pediatric emergency department in Toronto , Ontario , Canada .", "Participants were 213 otherwise healthy infants aged 4 weeks to 12 months with mild to moderate bronchiolitis and true oxygen saturations of 88 % or higher .", "Pulse oximetry measurements with true saturation values displayed or with altered saturation values displayed that have been increased 3 percentage points above true values .", "The primary outcome was hospitalization within 72 hours , defined as inpatient admission within this interval or active hospital care for greater than 6 hours .", "Secondary outcomes included the use of supplemental oxygen in the emergency department , level of physician agreement with discharge from the emergency department , length of emergency department stay , and unscheduled visits for bronchiolitis within 72 hours .", "Forty-four of 108 patients ( 41 % ) in the true oximetry group and 26 of 105 ( 25 % ) in the altered oximetry group were hospitalized within 72 hours ( difference , 16 % [ 95 % CI for the difference , 3.6 % to 28.4 % ] ; P = .005 ) .", "Using the emergency department physician as a random effect , the primary treatment effect remained significant ( adjusted odds ratio , 4.0 [ 95 % CI , 1.6 to 10.5 ] ; P = .009 ) .", "None of the secondary outcomes were significantly different between the groups .", "There were 23 of 108 ( 21.3 % ) subsequent unscheduled medical visits for bronchiolitis in the true oximetry group and 15 of 105 ( 14.3 % ) in the altered oximetry group ( difference , 7 % [ 95 % CI , -0.3 % to 0.2 % ] ; P = .18 ) .", "Among infants presenting to an emergency department with mild to moderate bronchiolitis , those with an artificially elevated pulse oximetry reading were less likely to be hospitalized within 72 hours or to receive active hospital care for more than 6 hours than those with unaltered oximetry readings .", "This suggests that oxygen saturation should not be the only factor in the decision to admit , and its use may need to be reevaluated .", "clinicaltrials.gov Identifier : NCT00673946 ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Voluntary medical male circumcision ( VMMC ) is a priority HIV preventive intervention .", "To facilitate VMMC scale-up , the World Health Organization is seeking circumcision techniques that are faster , easier , and safer than open surgical methods .", "To compare open surgical circumcision with suturing v. the Unicirc disposable instrument plus tissue adhesive .", "We conducted a non-blinded randomised controlled trial at an outpatient primary healthcare clinic in Cape Town , South Africa , with 2:1 allocation ratio of 150 male volunteers who were at least 18 years of age .", "Our primary outcome was intraoperative time and secondary outcomes were ease of performance , post-operative pain , adverse events , time to healing , patient satisfaction and cosmetic result .", "The intraoperative time was less with the Unicirc/adhesive technique ( median 13 v. 22.6 min , respectively ; p < 0.001 ) .", "The intraoperative suturing rate was 17 % using the Unicirc device .", "Other adverse events and wound healing outcomes were similar in both groups , but the cosmetic result was superior in the Unicirc group .", "Doctors found the Unicirc procedure easier to perform and preferred it to the open surgical technique .", "This study has important implications for the scale-up of VMMC services .", "Excising the foreskin with the Unicirc instrument and sealing the wound with cyanoacrylate tissue adhesive in adults is quicker , easier to learn , and is potentially safer than open surgical VMMC .", "Further studies should be conducted with the optimised device .", "This new instrument has the potential to facilitate more rapid scale-up and save costs ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To assess the antidepressant efficacy of S-adenosyl methionine ( SAMe ) , a naturally occurring methyl donor , versus the selective serotonin reuptake inhibitor ( SSRI ) escitalopram and a placebo control ; and to determine whether serum histamine or carnitine levels modified treatment response .", "We examined a subsample ( n = 144 ) from one site of a two-site study of adults with diagnosed Major Depressive Disorder ( MDD ) , recruited from 4/13/05 to 12/22/09 , who consented to the additional blood draw for serum histamine and carnitine levels .", "After washout , eligible subjects were randomized to SAMe ( 1600-3200mg / daily ) , escitalopram ( 10-20mg / daily ) , or matching placebo for 12 weeks of double-blind treatment ( titration at week 6 in non-response ) .", "On the primary outcome of the Hamilton Depression Rating Scale ( HAMD-17 ) , a significant difference in improvement was observed between groups from baseline to week 12 ( p = 0.039 ) .", "The effect size from baseline to endpoint was moderate to large for SAMe versus placebo ( d = 0.74 ) .", "SAMe was superior to placebo from week 1 , and to escitalopram during weeks 2 , 4 , and 6 .", "No significant effect was found between escitalopram and placebo or SAMe .", "Response rates ( HAMD-1750 % reduction ) at endpoint were 45 % , 31 % , and 26 % for SAMe , escitalopram , and placebo , respectively ; while remission rates ( HAM-D7 ) were 34 % for SAMe ( p = 0.003 ) , 23 % for escitalopram ( p = 0.023 ) , and 6 % for placebo .", "No correlation between baseline histamine level and reduction of HAMD-17 score was found for either the SAMe or escitalopram groups .", "Baseline carnitine levels were also not found to moderate response to either treatment .", "While SAMe appears to be an effective antidepressant agent , the overall findings from the parent study ( which showed no significant difference between groups due to site differences ) must be taken into consideration .", "These preliminary results provide encouraging evidence for the use of SAMe in the treatment of MDD .", "Histamine and carnitine serum level may not necessarily moderate response to SAMe ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To assess the longterm safety and effectiveness of tocilizumab ( TCZ ) in systemic-onset juvenile idiopathic arthritis ( sJIA ) .", "The longterm extension phase of 2 pivotal studies ( phase II with 11 patients and phase III with 56 patients ) in patients with active sJIA was analyzed .", "Patients received open-label TCZ ( 8 mg/kg , every 2 weeks ) without concomitant use of disease-modifying antirheumatic drugs .", "In total , 67 patients were enrolled .", "All patients received corticosteroid at baseline .", "Median duration of exposure to TCZ was 3.4 years .", "Nine patients withdrew from the study [ 4 because of adverse events ( AE ) , 4 because of the development of anti-TCZ antibodies , and 1 because of inadequate response ] .", "Rates of AE and serious AE were 803.7 / 100 patient-years ( PY ) and 34.7 / 100 PY , respectively .", "The most common serious AE were infections ( 13.2 / 100 PY ) .", "No cases of malignancy or death were reported .", "Two serious infusion reactions were reported in patients testing negative for anti-TCZ antibodies .", "One definite macrophage activation syndrome ( MAS ) case and 1 potential MAS case were identified .", "American College of Rheumatology ( ACR ) response rates attained early in the TCZ treatment period were maintained throughout the study : at Week 168 , JIA ACR 30 , 50 , 70 , 90 , and 100 response rates were 80.3 % , 80.3 % , 75.4 % , 60.7 % , and 18.0 % , respectively .", "In total , 22 of 67 patients ( 32.8 % ) completely discontinued corticosteroids without flare .", "TCZ has demonstrated durability of effectiveness in the longterm treatment of children with sJIA and has shown good tolerability and a low discontinuation rate associated with AE , development of anti-TCZ antibodies , or inadequate response .", "( ClinicalTrials.gov NCT00144599 and NCT00144612 ) .", "( First Release March 15 2014 ; J Rheumatol 2014 ; 41:759 -67 ; doi :10.3899 / jrheum .130690 ) ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The purpose of this study was to determine the effects of a multinutritional supplement including amino acids , - hydroxy -- methylbutyrate ( HMB ) , and carbohydrates on cytokine responses to resistance exercise and training .", "Seventeen healthy , college-aged men were randomly assigned to a Muscle Armor ( MA ; Abbott Nutrition , Columbus , OH ) or placebo supplement group and 12 weeks of resistance training .", "An acute resistance exercise protocol was administered at 0 , 6 , and 12 weeks of training .", "Venous blood samples at pre - , immediately post - , and 30-minutes postexercise were analyzed via bead multiplex immunoassay for 17 cytokines .", "After 12 weeks of training , the MA group exhibited decreased interferon-gamma ( IFN - ) and interleukin ( IL ) -10 .", "IL-1 differed by group at various times .", "Granulocyte colony-stimulating factor ( G-CSF ) , granulocyte-macrophage colony-stimulating factor ( GM-CSF ) , IL-6 , IL-7 , IL-8 , IL-12p70 , IL-13 , IL-17 , monocyte chemoattractant protein-1 ( MCP-1 ) , and macrophage inflammatory protein-1 beta ( MIP-1 ) changed over the 12-week training period but did not differ by group .", "Twelve weeks of resistance training alters the cytokine response to acute resistance exercise , and supplementation with HMB and amino acids appears to further augment this result ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To determine the short-term clinical effects of levosimendan in acute myocardial infarction ( AMI ) patients with myocardial stunning after emergency percutaneous coronary intervention ( PCI ) .", "The study population consisted of 30 patients with AMI who received emergency PCI and satisfied the inclusion criteria .", "Levosimendan was given as a continuous infusion of 0.1 g/kg/min for 24 h , and the remaining 10 patients received placebo treatment .", "The patients were observed with invasive haemodynamic monitoring and were evaluated biochemically and echocardiographically before and after the drug infusion .", "Following treatment , biochemical indices ( not including creatine kinase and its MB fraction ) were significantly lower in the levosimendan group than in the placebo group .", "Meanwhile , left-ventricular ( LV ) end-systolic volume , mean pulmonary arterial pressure , pulmonary capillary wedge pressure and systemic vascular resistance were significantly reduced in the levosimendan group , whereas the early-to-late diastolic velocities ratio , LV ejection fraction , cardiac index and cardiac power index were increased .", "Troponin I levels were reduced and fewer stunned and infarction segments were observed in the patients treated with levosimendan .", "Levosimendan can significantly improve the myocardium function of patients with myocardial stunning after PCI ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Treatment with rosiglitazone , a peroxisome proliferator-activated receptor - agonist , in type 2 diabetic mellitus ( T2DM ) patients is under scrutiny because it affects adversely cardiovascular outcomes .", "In T2DM patients , with existing coronary heart disease , short-term treatment with rosiglitazone increases myocardial glucose uptake ( MGU ) .", "Serum metabolic and lipoprotein subclass changes , which may be associated with this rosiglitazone-induced improvement , are unknown .", "Patients with both T2DM and coronary heart disease were separated into placebo ( n = 26 ) and treatment ( rosiglitazone 4-8 mg ; n = 25 ) groups .", "After 16 weeks of treatment , serum NMR metabolomics was used to measure circulating low-molecular-weight metabolites and lipoprotein subclasses and lipids that are associated with T2DM before and after the treatment .", "Significant metabolic measure changes after rosiglitazone treatment were correlated to MGU values assessed with [ ( 18 ) F ] fluorodeoxyglucose positron emission tomography .", "Compared to placebo , the treatment significantly increased circulating glutamine and decreased lactate concentrations .", "Circulating lactate concentrations showed a significant inverse association with MGU after rosiglitazone treatment .", "In T2DM patients with existing coronary heart disease , short-term rosiglitazone treatment caused minor improvements in metabolism : serum lactate and glutamine concentrations changed , reflecting improvements in insulin sensitivity , and circulating lactate concentrations inversely correlated to increases in myocardial glucose uptake ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "This study aims at ascertaining the capacity of 2 groups of young athletes to be faithful to the initial oral prevention project , with the difference that the study group received motivational reminders by either researchers and technical staff members of the team during the observation period , while the control group did not receive any motivational reminders .", "This observational study was based on two groups selected from a wide group of 150 adolescent basketball players who accepted to use a custom-made mouth guard during their sport sessions .", "None of the selected athletes ( 60 adolescents aged between 12 and 15 years ) had ever worn a mouth guard during their sports activity .", "A customised mouth guard was supplied , and subjetcs were requested to wear it for 12 months during training sessions and competitions .", "The study group was composed of 30 athletes , 15 males and 15 females , who received a constant motivational reinforcement to the use of the mouth guard by their coach and during checkups .", "Similarly , the control group was composed of 30 athletes ( 15 males and 15 females ) who did not receive any motivational reinforcement .", "Twelve months after the beginning of the study , 24 subjects belonging to the control group were not using the mouth guard , while only 7 subjects of the study group were not using it .", "It was also noticed , six months after the beginning of the observation period , a rapid decline in the participants ' interest in the use of the mouth guard .", "No traumatic event was registered among those adolescents who had used the mouth guard for the whole period of the study .", "Female athletes showed greater compliance to this prevention project .", "It is important that all technical staff members , and particularly the leading coach , encourage the regular use of oral protection devices for prevention among teenagers practicing sports ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Physical activity is important for a healthy lifestyle .", "Although physical activity can delay complications and decrease the burden of the disease , the level of activity of patients with chronic obstructive pulmonary disease ( COPD ) or type 2 Diabetes Mellitus ( DM2 ) is often far from optimal .", "To stimulate physical activity , a monitoring and feedback tool , consisting of an accelerometer linked to a smart phone and webserver ( It 's LiFe !", "tool ) , and a counselling protocol for practice nurses in primary care was developed ( the Self-management Support Program ) .", "The main objective of this study is to measure the longitudinal effects of this counselling protocol and the added value of using the tool .", "This three-armed cluster randomised controlled trial with 120 participants with COPD and 120 participants with DM2 ( aged 40-70 ) , compares the counselling protocol with and without the use of the tool ( group 1 and 2 ) with usual care ( group 3 ) .", "Recruitment takes place at GP practices in the southern regions of the Netherlands .", "Randomisation takes place at the practice level .", "The intended sample ( three arms of 8 practices ) powers the study to detect a 10-minute difference of moderate and intense physical activity per day between groups 1 and 3 .", "Participants in the intervention groups have to visit the practice nurse 3-4 times for physical activity counselling , in a 4-6-month period .", "Specific activity goals tailored to the individual patient 's preferences and needs will be set .", "In addition , participants in group 1 will be instructed to use the tool in daily life .", "The primary outcome , physical activity , will be measured in all groups with a physical activity monitor ( PAM ) .", "Secondary outcomes are quality of life , general - and exercise - self-efficacy , and health status .", "Follow-up will take place after 6 and 9months .", "Separately , a process evaluation will be conducted to explore reasons for trial non-participation , and the intervention 's acceptability for participating patients and nurses .", "Results of this study will give insight into the effects of the It 's LiFe !", "monitoring and feedback tool combined with care from a practice nurse for people with COPD or DM2 on physical activity .", "ClinicalTrials.gov : NCT01867970 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Pre-exposure prophylaxis ( PrEP ) may be an important safer conception strategy for HIV-1-uninfected women with HIV-1-infected partners .", "Understanding medication adherence in this population may inform whether PrEP is a feasible safer conception strategy .", "We evaluated predictors of pregnancy and adherence to study medication among HIV-1-uninfected women enrolled in a randomized placebo-controlled trial of PrEP among African HIV-1-serodiscordant couples .", "Participants were counseled on HIV-1 risk reduction , contraception , and adherence and tested for pregnancy at monthly study visits .", "Pill counts of dispensed drug were performed and , at a subset of visits , plasma was collected to measure active drug concentration .", "Among 1785 women , pregnancy incidence was 10.2 per 100 person-years .", "Younger age , not using contraception , having an additional sexual partner , and reporting unprotected sex were associated with increased likelihood of pregnancy .", "Monthly clinic pill counts estimated that women experiencing pregnancy took 97 % of prescribed doses overall , with at least 80 % pill adherence for 98 % of study months , and no difference in adherence in the periconception period compared with previous periods ( P = 0.98 ) .", "Tenofovir was detected in plasma at 71 % of visits where pregnancy was discovered .", "By multiple measures , adherence was similar for women experiencing and not experiencing pregnancy ( P 0.1 ) .", "In this clinical trial of PrEP , pregnancy incidence was 10 % per year despite excellent access to effective contraception .", "Women experiencing pregnancy had high medication adherence , suggesting that PrEP may be an acceptable and feasible safer conception strategy for HIV-1-uninfected women with HIV-1-serodiscordant partners ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Patients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of safety and efficacy is poor .", "We have therefore studied the combination of different antithrombotic medicines for coagulation activation in an in vivo model in the skin microvasculature .", "Platelet activation ( - thromboglobulin [ - TG ] ) and thrombin generation ( prothrombin fragment 1 + 2 [ F1 +2 ] , thrombin-antithrombin complex [ TAT ] ) were studied in an open-label , randomized , parallel group trial in 60 healthy male subjects ( n = 20 per group ) who received ticagrelor and acetylsalicylic acid ( ASA ) in combination with dabigatran ( 150 mg bid ) , rivaroxaban ( 20 mg od ) or phenprocoumon ( INR 2.0-3 .0 ) .", "Coagulation biomarkers in shed blood were assessed at 3 h after monotherapy with the medicines under study , at 3 h after triple therapy dosing and at steady state trough conditions .", "Single doses of ticagrelor , dabigatran or rivaroxaban caused comparable decreases in shed blood - TG and were more pronounced than phenprocoumon at an INR of 2.0-3 .0 .", "In contrast , thrombin generation was more affected by rivaroxaban and phenprocoumon than by dabigatran .", "During triple therapy a similarly sustained inhibition of platelet activation and thrombin generation with a maximum decrease of - TG , F1 +2 and TAT at 3 h post-dosing was noted , which remained below pre-dose levels at trough steady state .", "A triple therapy at steady state with ticagrelor plus ASA in combination with dabigatran or rivaroxaban is as effective as a combination with phenprocoumon for platelet activation and thrombin generation in vivo ." ]

[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Apremilast works intracellularly to regulate inflammatory mediators .", "ESTEEM 1 evaluated efficacy/safety of apremilast at 30 mg twice a day for moderate to severe plaque psoriasis .", "This phase III , multicenter , double-blind , placebo-controlled study randomized adults ( 2:1 ) to apremilast or placebo .", "At week 16 , the placebo group switched to apremilast through week 32 , followed by a randomized treatment withdrawal phase to week 52 .", "Binary end points were analyzed using ( 2 ) test ; continuous end points used analysis of covariance .", "In all , 844 patients were randomized ( n = 282 , placebo ; n = 562 , apremilast ) .", "At week 16 , significantly more patients taking apremilast achieved 75 % or greater reduction from baseline Psoriasis Area and Severity Index score ( PASI-75 ) ( 33.1 % ) versus placebo ( 5.3 % , P < .0001 ; primary end point ) .", "Most ( 61.0 % ) patients rerandomized to apremilast at week 32 achieved PASI-75 at week 52 versus 11.7 % rerandomized to placebo .", "Of patients rerandomized to apremilast at week 32 , mean percentage change from baseline PASI score was -88 % to -81 % ( weeks 32-52 ) .", "During the placebo-controlled period , 55.7 % and 69.3 % of patients randomized toplacebo and apremilast , respectively , had 1 or more adverse events .", "Most adverse events were mild/moderate in severity .", "No new significant adverse events emerged with continued apremilast exposure versus the placebo-controlled period .", "Data were limited to 52 weeks and may not generalize to nonplaque psoriasis .", "Apremilast was effective in moderate to severe plaque psoriasis ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To clarify the potential value of second-look laparoscopy ( SLL ) in improving fertility outcomes after laparoscopic salpingostomy for tubal pregnancy .", "Randomized controlled trial .", "West China Second University Hospital , Sichuan University .", "216 women with future birth demand who underwent laparoscopic salpingostomy for tubal pregnancy .", "SLL was performed in the SLL group at 3 months after the primary surgery .", "In both the SLL and control groups , the subjects were assigned to a slight adhesion ( SLA ) or severe adhesion ( SEA ) subgroup .", "At 3-year follow-up , the fertility outcomes were compared between the SLL and control groups and also between the SLA and SEA subgroups .", "The intrauterine pregnancy rate was higher in the SLL group compared with the control group ( 63.1 % vs 48.6 % ; p = .032 ) , and the incidence of recurrent ectopic pregnancy was lower in the SLL group than in the control group ( 6.3 % vs 16.2 % ; p = .021 ) .", "In the control group , the cumulative pregnancy rate was higher in the SLA subgroup compared with the SEA subgroup ( p = .017 ) , but in the SLL group , the cumulative pregnancy rate did not differ between the 2 subgroups ( p = .502 ) .", "The cumulative pregnancy rate was higher in the SEA subgroup of the SLL group compared with the SEA subgroup of the control group ( p = .014 ) , but did not differ between the SLA subgroup of the SLL group and the SLA subgroup of the control group ( p = .456 ) .", "SLL may improve subsequent fertility outcome after laparoscopic salpingostomy for tubal pregnancy , and may be especially recommended for women with severe and extensive pelvic adhesions ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Optimum management strategies for patients with advanced non-small-cell lung cancer ( NSCLC ) with acquired resistance to EGFR tyrosine-kinase inhibitors are undefined .", "We aimed to assess the efficacy and safety of continuing gefitinib combined with chemotherapy versus chemotherapy alone in patients with EGFR-mutation-positive advanced NSCLC with acquired resistance to first-line gefitinib .", "The randomised , phase 3 , multicentre IMPRESS study was done in 71 centres in 11 countries in Europe and the Asia-Pacific region .", "Eligible patients were aged at least 18 years with histologically confirmed , chemotherapy-naive , stage IIIB-IV EGFR-mutation-positive advanced NSCLC with previous disease control with first-line gefitinib and recent disease progression ( Response Evaluation Criteria in Solid Tumors version 1.1 ) .", "Participants were randomly assigned ( 1:1 ) by central block randomisation to oral gefitinib 250 mg or placebo once daily in tablet form ; randomisation did not include stratification factors .", "All patients also received the platinum-based doublet chemotherapy cisplatin 75 mg/m ( 2 ) plus pemetrexed 500 mg/m ( 2 ) on the first day of each cycle .", "After completion of a maximum of six chemotherapy cycles , patients continued their randomly assigned treatment until disease progression or another discontinuation criterion was met .", "All study investigators and participants were masked to treatment allocation .", "The primary endpoint was progression-free survival in the intention-to-treat population .", "Safety was assessed in patients who received at least one dose of study treatment .", "The study has completed enrolment , but patients are still in follow-up for overall survival .", "This trial is registered with ClinicalTrials.gov , number NCT01544179 .", "Between March 29 , 2012 , and Dec 20 , 2013 , 265 patients were randomly assigned : 133 to the gefitinib group and 132 to the placebo group .", "At the time of data cutoff ( May 5 , 2014 ) , 98 ( 74 % ) patients had disease progression in the gefitinib group compared with 107 ( 81 % ) in the placebo group ( hazard ratio 086 , 95 % CI 065-113 ; p = 027 ; median progression-free survival 54 months in both groups [ 95 % CI 45-57 in the gefitinib group and 46-55 in the placebo group ] ) .", "The most common adverse events of any grade were nausea ( 85 [ 64 % ] of 132 patients in the gefitinib group and 81 [ 61 % ] of 132 patients in the placebo group ) and decreased appetite ( 65 [ 49 % ] and 45 [ 34 % ] ) .", "The most common adverse events of grade 3 or worse were anaemia ( 11 [ 8 % ] of 132 patients in the gefitinib group and five [ 4 % ] of 132 patients in the placebo group ) and neutropenia ( nine [ 7 % ] and seven [ 5 % ] ) .", "37 ( 28 % ) of 132 patients in the gefitinib group and 28 ( 21 % ) of 132 patients in the placebo group reported serious adverse events .", "Continuation of gefitinib after radiological disease progression on first-line gefitinib did not prolong progression-free survival in patients who received platinum-based doublet chemotherapy as subsequent line of treatment .", "Platinum-based doublet chemotherapy remains the standard of care in this setting .", "AstraZeneca ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "During endoscopic retrograde cholangiopancreatography ( ERCP ) , a guidewire is used to cannulate biliary strictures and allow for therapeutic interventions .", "The aim of this study was to assess the success of stricture cannulation using a combination of a flexible guidewire and a stable nitinol wire vs. a novel , single , stiff-shaft , flexible-tip guidewire .", "Consecutive patients who were scheduled for ERCP for biliary obstruction were randomized to undergo the procedure with either a 260-cm long , angled-tip hydrophilic wire in combination with a nitinol wire as required ( standard group ) , or a novel , 270-cm guidewire featuring a hyperflexible , hydrophilic tip with a stiff shaft ( novel group ) .", "At unsuccessful negotiation of the stricture , patients in the standard group were switched to the novel guidewire and vice versa ( `` crossover '' ) .", "Successful cannulation ( primary success : as assigned ; final success : after `` crossover '' ) , procedure time , and total number of wires needed per procedure were compared .", "A total of 222 patients were randomized and 197 were included in the study ( 97 in the standard group and 100 in the novel group ) .", "The primary success rate was significantly higher in the novel group ( 94/100 , 94 % ) compared with the standard group ( 77/97 , 79 % ; P = 0.00041 ) , and final success was similar .", "Mean time ( median , interquartile range ) to stricture cannulation was 11.2 minutes ( 6.3 , 3.7-14 .6 ) in the standard group and 8.1 minutes ( 2.5 , 0.9-7 .7 ) in the novel group ( P < 0.0001 ) .", "The mean total procedure time was 31.2 minutes ( 24.6 , 16.5-40 .8 ) vs. 24.3 minutes ( 16.9 , 10.0-31 .5 ) , respectively ( P = 0.0011 ) .", "There were no complications observed with either of the guidewires .", "A guidewire that features a flexible tip with a stable shaft could replace the use of a combination of flexible and stable guidewires and increase the success rate of stricture cannulation while decreasing the procedure time.ClinicalTrials.gov Identifier : NCT 01382680 ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Questions enhance learning in Web-based courses , but preliminary evidence suggests that too many questions may interfere with learning .", "The authors sought to determine how varying the number of self-assessment questions affects knowledge outcomes in a Web-based course .", "The authors conducted a randomized crossover trial in one internal medicine and one family medicine residency program between January 2009 and July 2010 .", "Eight Web-based modules on ambulatory medicine topics were developed , with varying numbers of self-assessment questions ( 0 , 1 , 5 , 10 , or 15 ) .", "Participants completed modules in four different formats each year , with sequence randomly assigned .", "Participants completed a pretest for half their modules .", "Outcomes included knowledge , completion time , and module ratings .", "One hundred eighty residents provided data .", "The mean ( standard error ) percent correct knowledge score was 53.2 ( 0.8 ) for pretests and 73.7 ( 0.5 ) for posttests .", "In repeated-measures analysis pooling all data , mean posttest knowledge scores were highest for the 10 - and 15-question formats ( 75.7 [ 1.1 ] and 74.4 [ 1.0 ] , respectively ) and lower for 0 - , 1 - , and 5-question formats ( 73.1 [ 1.3 ] , 72.9 [ 1.0 ] , and 72.8 [ 1.5 ] , respectively ) ; P = .04 for differences across all modules .", "Modules with more questions generally took longer to complete and were rated higher , although differences were small .", "Residents most often identified 10 questions as ideal .", "Posttest knowledge scores were higher for modules that included a pretest ( 75.4 [ 0.9 ] versus 72.2 [ 0.9 ] ; P = .0002 ) .", "Increasing the number of self-assessment questions improves learning until a plateau beyond which additional questions do not add value ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Low compliance with training programs is likely to be one of the major reasons for inconsistency of the data regarding the effectiveness of current anterior cruciate ligament ( ACL ) injury prevention programs .", "Training methods that reduce training time and cost could favorably influence the effectiveness of ACL injury prevention programs .", "A newly designed knee extension constraint training device may serve this purpose .", "( 1 ) Knee extension constraint training for 4 weeks would significantly increase the knee flexion angle at the time of peak impact posterior ground-reaction force and decrease peak impact ground-reaction forces during landing of a stop-jump task and a side-cutting task , and ( 2 ) the training effects would be retained 4 weeks after completion of the training program .", "Controlled laboratory study .", "Twenty-four recreational athletes were randomly assigned to group A or B. Participants in group A played sports without wearing a knee extension constraint device for 4 weeks and then played sports while wearing the device for 4 weeks , while participants in group B underwent a reversed protocol .", "Both groups were tested at the beginning of week 1 and at the ends of weeks 4 and 8 without wearing the device .", "Knee joint angles were obtained from 3-dimensional videographic data , while ground-reaction forces were measured simultaneously using force plates .", "Analyses of variance were performed to determine the training effects and the retention of training effects .", "Participants in group A significantly increased knee flexion angles and decreased ground-reaction forces at the end of week 8 ( P .012 ) .", "Participants in group B significantly increased knee flexion angles and decreased ground-reaction forces at the ends of weeks 4 and 8 ( P .007 ) .", "However , participants in group B decreased knee flexion angles and increased ground-reaction forces at the end of week 8 in comparison with the end of week 4 ( P .009 ) .", "Knee extension constraint training for 4 weeks significantly altered lower extremity movement patterns and transferred these changes in lower extremity movement patterns to stop-jump and side-cutting tasks in which ACL injuries frequently occur .", "Training effects were retained 4 weeks after the training was completed but were diminished in magnitude .", "A knee extension constraint device may be a useful training tool in future ACL injury prevention programs to alter movement patterns without extra training time ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The risk of cardiovascular disease is tremendously high in dialysis patients .", "Dialysis patients treated with vitamin D analogs show decreased cardiovascular morbidity and mortality compared with untreated patients .", "We examined the influence of two common vitamin D analogs , alfacalcidol and paricalcitol , on important cardiovascular biomarkers in hemodialysis patients .", "Anti-inflammatory effects and the influence on regulators of vascular calcification as well as markers of heart failure were examined .", "In 57 chronic hemodialysis patients enrolled in a randomized crossover trial comparing paricalcitol and alfacalcidol , we examined the changes in osteoprotegerin , fetuin-A , NT-proBNP , hs-Crp , IL-6 and TNF - , during 16weeks of treatment .", "NT-proBNP and osteoprotegerin increased comparably in the paricalcitol and alfacalcidol-treated groups .", "Fetuin-A increased significantly in the alfacalcidol-treated group compared with the paricalcitol-treated group ( difference 32.84 mol/l ( 95 % C.I. ; range 0.21-67 .47 ) ) during the first treatment period .", "No difference was found between the groups during the second treatment period , and IL-6 , TNF - and hs-Crp were unchanged in both treatment groups .", "Paricalcitol and alfacalcidol modulate regulators of vascular calcification .", "Alfacalcidol may increase the level of the calcification inhibitor fetuin-A .", "We did not find any anti-inflammatory effect or difference in changes of NT-proBNP .", "ClinicalTrials.gov NCT00469599 May 3 2007 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Men with advanced prostate cancer ( APC ) undergoing androgen deprivation therapy ( ADT ) often experience distressing sexual side effects .", "Sexual bother is an important component of adjustment .", "Factors associated with increased bother are not well understood .", "This study sought to describe sexual dysfunction and bother in APC patients undergoing ADT , identify socio-demographic and health/disease-related characteristics related to sexual bother , and evaluate associations between sexual bother and psychosocial well-being and quality of life ( QOL ) .", "Baseline data of a larger psychosocial intervention study was used .", "Pearson 's correlation and independent samples t-test tested bivariate relations .", "Multivariate regression analysis evaluated relations between sexual bother and psychosocial and QOL outcomes .", "The Expanded Prostate Cancer Index Composite sexual function and bother subscales , Center for Epidemiologic Studies Depression Scale , Functional Assessment of Cancer Therapy -- General , and Dyadic Adjustment Scale were the main outcome measures .", "Participants ( N = 80 ) were 70 years old ( standard deviation [ SD ] = 9.6 ) and reported 18.7 months ( SD = 17.3 ) of ADT .", "Sexual dysfunction ( mean = 10.1 ; SD = 18.0 ) was highly prevalent .", "Greater sexual bother ( lower scores ) was related to younger age ( = 0.25 , P = 0.03 ) and fewer months of ADT ( = 0.22 , P = 0.05 ) .", "Controlling for age , months of ADT , current and precancer sexual function , sexual bother correlated with more depressive symptoms ( = -0.24 , P = 0.06 ) and lower QOL ( = 0.25 , P = 0.05 ) .", "Contrary to hypotheses , greater sexual bother was related to greater dyadic satisfaction ( = -0.35 , P = 0.03 ) and cohesion ( = -0.42 , P = 0.01 ) .", "The majority of APC patients undergoing ADT will experience sexual dysfunction , but there is variability in their degree of sexual bother .", "Psychosocial aspects of sexual functioning should be considered when evaluating men 's adjustment to ADT effects .", "Assessment of sexual bother may help identify men at risk for more general distress and lowered QOL .", "Psychosocial interventions targeting sexual bother may complement medical treatments for sexual dysfunction and be clinically relevant , particularly for younger men and those first starting ADT ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To investigate the pharmacokinetic/pharmacodynamic ( PK/PD ) interaction between irbesartan ( IRB ) and hydrochlorothiazide ( HCT ) in normotensive subjects .", "A three-way crossover study was used .", "Serial drug concentrations and drug effects , including systolic and diastolic blood pressure and heart rate were monitored after administration of irbesartan and hydrochlorothiazide alone and in combination .", "The data were fitted to a PK/PD model and the parameters for irbesartan and hydrochlorothiazide when administered alone and in combination were compared .", "The plasma profiles for irbesartan and hydrochlorothiazide followed the two-compartment model after a single dose .", "The PK parameters of irbesartan were not affected by hydrochlorothiazide ; however irbesartan decreased the hydrochlorothiazide AUC by 25 % and increased its clearance by 25 % .", "There were no significant changes in heart rate after each drug alone or in combination .", "Irbesartan plus hydrochlorothiazide had a greater blood pressure lowering effect compared with irbesartan alone , despite the unchanged irbesartan PK .", "The relationship between irbesartan plasma concentration and its effects plotted in chronological order showed anticlockwise hysteresis .", "The PD parameter estimates for the effect of irbesartan on systolic blood pressure , when administered with hydrochlorothiazide were significantly different from those when irbesartan was administered alone .", "This was manifested by a 25 % increase in Emax , and a 40 % decrease in EC50 , suggesting a synergistic blood pressure lowering effect for the combination .", "While parameter estimates for the effect of irbesartan on diastolic blood pressure were changed by hydrochlorothiazide , the differences were only significant for EC50 .", "A limited potential for clinically significant interactions between irbesartan and hydrochlorothiazide at the given doses were observed ; therefore , no dosage adjustments were recommended for either drug when used together .", "( ClinicalTrials.gov Identifier NCT01858610 )" ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To investigate a saddle anesthesia with different doses of chloroprocaine in perianal surgery .", "Total 60 Patients aged 18-75 years ( Anesthesiologists grade I or II ) scheduled to receive perianal surgery .", "Patients using saddle anesthesia were randomized to group A , group B and group C with the same concentration ( 0.5 % ) chloroprocaine with different doses 1.0 mL , 0.8 mL and 0.6 mL , respectively .", "Systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , heart rate ( HR ) and the sensory and motor block were recorded to evaluate the anesthesia effect of chloroprocaine in each group .", "The duration of sensory block of group C is shorter than those of group A and B.", "The maximum degree of motor block is observed ( group C : 0 level , group A : III level ; and group B : I level ) after 15 minutes .", "Besides , there was a better anesthetic effect in group B than group A and group C , such as walking after saddle anesthesia .", "However , there is also no significant difference of blood pressure decreasing in these three groups .", "It 's worth to employ a saddle anesthesia with appropriate doses of chloroprocaine in clinical perianal surgery ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Controlled somatosensory stimulation strategies have demonstrated merit in developing oral feeding skills in premature infants who lack a functional suck , however , the effects of orosensory entrainment stimulation on electrocortical dynamics is unknown .", "The objective of the study was to determine the effects of servo-controlled pneumatic orocutaneous stimulation presented during gavage feedings on the modulation of amplitude-integrated electroencephalogram ( aEEG ) and range electroencephalogram ( rEEG ) activity .", "Two-channel EEG recordings were collected during 180 sessions that included orocutaneous stimulation and non-stimulation epochs among 22 preterm infants ( mean gestational age = 28.56 weeks ) who were randomized to treatment and control ` sham ' conditions .", "The study was initiated at around 32 weeks post-menstrual age .", "The raw EEG was transformed into aEEG margins , and rEEG amplitude bands measured at 1-min intervals and subjected to a mixed models statistical analysis .", "Multiple significant effects were observed in the processed EEG during and immediately following 3-min periods of orocutaneous stimulation , including modulation of the upper and lower margins of the aEEG , and a reorganization of rEEG with an apparent shift from amplitude bands D and E to band C throughout the 23-min recording period that followed the first stimulus block when compared with the sham condition .", "Cortical asymmetry also was apparent in both EEG measures .", "Orocutaneous stimulation represents a salient trigeminal input , which has both short - and long-term effects in modulating electrocortical activity , and thus is hypothesized to represent a form of neural adaptation or plasticity that may benefit the preterm infant during this critical period of brain maturation ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Impaired pulmonary gas exchange after cardiac surgeries with cardiopulmonary bypass ( CPB ) often occurs , and the selection of mechanical ventilation mode , pressure-controlled ventilation ( PCV ) or volume-controlled ventilation ( VCV ) , may be important for preventing hypoxia and improving oxygenation .", "The authors hypothesized that patients with PCV would show better oxygenation , compared with VCV , during one-lung ventilation ( OLV ) for mitral valve repair surgery ( MVP ) via thoracotomy .", "Randomized controlled trial .", "University teaching hospital .", "Sixty patients in each group .", "MVP was performed using thoracotomy with OLV by PCV or VCV .", "Arterial partial pressure of oxygen ( PaO2 ) and fraction of inspired oxygen ( FIO2 ) were measured before anesthesia induction ( T0 ) , at skin incision ( T1 ) , after administration of heparin ( T2 ) , at 30 minutes after CPB weaning ( T3 ) , just before departure from the operating room to the intensive care unit ( ICU ) ( T4 ) , and 1 hour after ICU admission ( T5 ) , and PaO2/FIO2 ratio was calculated .", "Peak inspiratory pressure ( PIP ) and mean inspiratory pressure ( Pmean ) were recorded at T1 , T2 , T3 , and T4 .", "No significant difference was noted in the PaO2/FIO2 ratio between the groups at any measured point .", "PIP in the PCV group at all measured points was lower than that in the VCV group ( T1 , p < 0.001 ; T2 , p < 0.001 ; T3 , p < 0.001 ; T4 , p = 0.025 , respectively ) .", "Pmean was not different between the two groups at any measured point .", "PCV during OLV in patients undergoing MVP via a thoracotomy with OLV showed lower PIP compared with VCV , but this did not improve pulmonary gas exchange ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Currently available disease-modifying treatments acting by modifying the immune response are ineffective in progressive multiple sclerosis ( MS ) , which is caused by a widespread axonal degeneration .", "Mechanisms suspected to be involved in this widespread axonal degeneration are reduced axonal energy metabolism , axonal glutamate toxicity , and reduced cerebral blood flow .", "Fluoxetine might theoretically reduce axonal degeneration in MS because it stimulates energy metabolism through enhancing glycogenolysis , stimulates the production of brain-derived neurotrophic factor , and dilates cerebral arterioles .", "The current document presents the protocol of a clinical trial to test the hypothesis that fluoxetine slows down the progressive phase of MS.", "The FLUOX-PMS trial is a multi-center , randomized , controlled and double-blind clinical study .", "A total of 120 patients with the diagnosis of either secondary or primary progressive MS will be treated either by fluoxetine ( 40 mg daily ) or placebo for a total period of 108 weeks .", "The primary endpoint is the time to confirmed disease progression defined as either at least a 20 % increase in the timed 25-Foot Walk or at least a 20 % increase in the 9-Hole Peg Test .", "Secondary endpoints include the Hauser ambulation index , cognitive changes , fatigue , magnetic resonance imaging of the brain , and in a small subgroup optical coherence tomography .", "The FLUOX-PMS trial will gives us information as to whether fluoxetine has neuroprotective effects in patients with progressive MS.", "Eudra-CT : 2011-003775-11 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND" ]

[ "The apolipoprotein A5 gene ( APOA5 ) -1131 T > C polymorphism is associated with mild hypertriglyceridemia in type 2 diabetic subjects , and interacts with dietary fat in the determination of triglyceride concentrations .", "We examined whether a substitution of whole grains and legumes for refined rice in a high carbohydrate diet ( about 65 % of energy derived from carbohydrate ) may modify the effect of this variant on changes in apolipoprotein A-V ( apoA-V ) and triglyceride concentrations .", "We genotyped the APOA5 -1131 T > C in individuals with impaired fasting glucose ( IFG ) or newly diagnosed type 2 diabetes , who were randomly assigned to either a group ingesting whole grain and legume meals daily or a control group for 12weeks .", "After dietary intervention , we observed significant interactions between the APOA5 -1131 T > C polymorphism and carbohydrate sources ( whole grains and legumes versus refined rice ) in the determination of mean percent changes in triglyceride and apoA-V ( P interactions < 0.001 and = 0.038 , respectively ) .", "In the refined rice group ( n = 93 ) , the carriers of the risk C allele ( n = 50 ) showed a greater increase in the mean percent changes of triglyceride and apoA-V than noncarriers after adjusting for HOMA-IR ( P = 0.004 and 0.021 , respectively ) .", "The whole grain and legume group ( n = 92 ) , however , showed a decrease in fasting glucose , HOMA-IR , and triglyceride , and an increase in apoA-V , irrespective of genotype .", "The data showed that the magnitude of the genetic effect of the APOA5 -1131 C variant on triglyceride and apoA-V levels was modulated when substituting consumption of whole grains and legumes for refined rice as a carbohydrate source in IFG or diabetic subjects .", "ClinicalTrials.gov : NCT01784952 ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "Most patients with facial scarring would value even a slight improvement in scar quality .", "Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing .", "The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds .", "In this double-blinded , randomized , vehicle-controlled , prospective clinical trial , 60 consecutive consenting adults undergoing cleft lip scar revision ( CLSR ) surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A ( n = 30 ) or vehicle ( normal saline ; n = 30 ) injections into the subjacent orbicularis oris muscle immediately after wound closure .", "Scars were independently assessed at 6-months follow-up in blinded fashion using : Vancouver Scar Scale ( VSS ) , Visual Analogue Scale ( VAS ) and photographic plus ultrasound measurements of scar widths .", "58 patients completed the trial .", "All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group .", "Quality of surgical upper lip scars , which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle , is significantly improved by its temporary paralysis during wound healing .", "ClinicalTrials.gov NCT01429402 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "Evaluate the utility of 2 electronic medical record ( EMR ) - linked , automated phone reminder interventions for improving adherence to cardiovascular disease medications .", "A 1-year , parallel arm , pragmatic clinical trial in which 21,752 adults were randomized to receive either usual care ( UC ) or 1 of 2 interventions in the form of interactive voice recognition calls-regular ( IVR ) or enhanced ( IVR + ) .", "The interventions used automated phone reminders to increase adherence to cardiovascular disease medications .", "The primary outcome was medication adherence ; blood pressure and lipid levels were secondary outcomes .", "The study took place in 3 large health maintenance organizations .", "We enrolled participants who were 40 years or older , had diabetes mellitus or atherosclerotic cardiovascular disease , and were suboptimally adherent .", "IVR participants received automated phone calls when they were due or overdue for a refill .", "IVR + participants received these phone calls , plus personalized reminder letters , live outreach calls , EMR-based feedback to their primary care providers , and additional mailed materials .", "Both interventions significantly increased adherence to statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers ( ACEIs/ARBs ) compared with UC ( 1.6 to 3.7 percentage points ) .", "Adherence to ACEIs/ARBs was also significantly higher for IVR + relative to IVR participants .", "These differences persisted across subgroups .", "Among statin users , IVR + participants had significantly lower low-density lipoprotein ( LDL ) levels at follow-up compared with UC ( = -1.5 ; 95 % CI , -2.7 to -0.2 mg/dL ) ; this effect was seen mainly in those with baseline LDL levels 100 mg/dL ( = -3.6 ; 95 % CI , -5.9 to -1.3 mg/dL ) .", "Technology-based tools , in conjunction with an EMR , can improve adherence to chronic disease medications and measured cardiovascular disease risk factors ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Ischaemia-reperfusion injury following acute myocardial infarctions ( AMI ) is an unavoidable consequence of the primary percutaneous coronary intervention ( pPCI ) procedure .", "A pivotal mechanism in ischaemia-reperfusion injury is the production of reactive oxygen species following reperfusion .", "The endogenous hormone , melatonin , works as an antioxidant and could potentially minimise the ischaemia-reperfusion injury .", "Given intracoronarily , it enables melatonin to work directly at the site of reperfusion .", "We wish to test if melatonin , as an antioxidant , can minimise the reperfusion injury following pPCI in patients with AMI .", "The IMPACT trial is a multicentre , randomised , double-blinded , placebo-controlled study .", "We wish to include 2 20 patients with ST-elevation myocardial infarctions undergoing pPCI within six hours from symptom onset .", "The primary end-point is the Myocardial Salvage Index assessed by cardiovascular magnetic resonance imaging on day 4 ( 1 ) after pPCI .", "The secondary end-points are high-sensitivity troponin , creatinekinase myocardial band and clinical events .", "The aim of the IMPACT trial is to evaluate the effect of melatonin on reperfusion injuries following pPCI .", "Owing to its relatively non-toxic profile , melatonin is an easily implementable drug in the clinical setting , and melatonin has the potential to reduce morbidity in patients with AMI .", "This study received no financial support from the industry .", "www.clinicaltrials.gov , clinical trials identifier : NCT01172171 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "The public typically believes psychotherapy to be more effective than pharmacotherapy for depression treatments .", "This is not consistent with current scientific evidence , which shows that both types of treatment are about equally effective .", "The study investigates whether this bias towards psychotherapy guides online information search and whether the bias can be reduced by explicitly providing expert information ( in a blog entry ) and by providing tag clouds that implicitly reveal experts ' evaluations .", "A total of 174 participants completed a fully automated Web-based study after we invited them via mailing lists .", "First , participants read two blog posts by experts that either challenged or supported the bias towards psychotherapy .", "Subsequently , participants searched for information about depression treatment in an online environment that provided more experts ' blog posts about the effectiveness of treatments based on alleged research findings .", "These blogs were organized in a tag cloud ; both psychotherapy tags and pharmacotherapy tags were popular .", "We measured tag and blog post selection , efficacy ratings of the presented treatments , and participants ' treatment recommendation after information search .", "Participants demonstrated a clear bias towards psychotherapy ( mean 4.53 , SD 1.99 ) compared to pharmacotherapy ( mean 2.73 , SD 2.41 ; t173 = 7.67 , P < .001 , d = 0.81 ) when rating treatment efficacy prior to the experiment .", "Accordingly , participants exhibited biased information search and evaluation .", "This bias was significantly reduced , however , when participants were exposed to tag clouds with challenging popular tags .", "Participants facing popular tags challenging their bias ( n = 61 ) showed significantly less biased tag selection ( F2 ,168 = 10.61 , P < .001 , partial eta squared = 0.112 ) , blog post selection ( F2 ,168 = 6.55 , P = .002 , partial eta squared = 0.072 ) , and treatment efficacy ratings ( F2 ,168 = 8.48 , P < .001 , partial eta squared = 0.092 ) , compared to bias-supporting tag clouds ( n = 56 ) and balanced tag clouds ( n = 57 ) .", "Challenging ( n = 93 ) explicit expert information as presented in blog posts , compared to supporting expert information ( n = 81 ) , decreased the bias in information search with regard to blog post selection ( F1 ,168 = 4.32 , P = .04 , partial eta squared = 0.025 ) .", "No significant effects were found for treatment recommendation ( Ps > .33 ) .", "We conclude that the psychotherapy bias is most effectively attenuated-and even eliminated-when popular tags implicitly point to blog posts that challenge the widespread view .", "Explicit expert information ( in a blog entry ) was less successful in reducing biased information search and evaluation .", "Since tag clouds have the potential to counter biased information processing , we recommend their insertion ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Several combined spinal-epidural ( CSE ) anesthesia techniques have been described .", "This study was designed to compare the single space ( `` needle-through-needle '' ) technique ( SST ) and the double distant space technique ( DDS ) with regards to the time needed for the procedure , patient discomfort during the procedure and patient 's preference technique .", "This prospective , randomized single-blind study included 156 patients undergoing colorectal surgery under general anesthesia and CSE .", "All neuraxial blocks were performed before general anesthesia induction .", "DDS group of patients had thoracic epidural catheter placed at T6-7 or T7-8 , followed by subarachnoid injection at the L2-3 interspace .", "The SST group of patients had a single injection using the needle-through-needle technique ( Espocan needle ) at L2-3 .", "The epidural catheter was used for postoperative analgesia for 72 hours .", "Body habitus , spinal anatomy and spinal landmarks were assessed preoperatively .", "The number of epidural and spinal punctures , the feeling that the dura is perforated ( dural perforation click ) and the time needed to perform CSE were also recorded .", "Complications during epidural catheter placement and perioperative and postoperative epidural catheter function and patient preference for the anesthetic procedure were recorded .", "Epidural and subarachnoid spaces were successfully identified in all the patients .", "Duration of CSE procedure , the number of spinal punctures , dural click feeling and the effects of test dose did not differ between the groups .", "The patients in both groups ( 90 % of DDS and 87 % of SST ) would choose CSE as preferred method in the future .", "The CSE procedure was painful for 16 % of DDS vs 20 % of SST patients .", "A significant correlation between time needed for CSE technique performance and body habitus ( r = 0.338 , p < 0.01 ) , spinal landmarks ( r = 0.452 , p < 0.001 ) and anatomy ( r = 0.265 , p < 0.05 ) was found in the SST group .", "There was no correlation between the number of epidural/spinal punctures and epidural bacteriological findings .", "There was no correlation between the patients ' choice of the CSE technique and the number of spinal punctures , duration of CSE procedure and epidural catheter stay .", "The two CSE techniques did not differ with regards to the procedure time and patient 's preference .", "Procedure time correlated with body habitus , spinal landmarks and the anatomy in the SST group ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To assess the effect of analgesia at disbudding on weight gain and milk intake of dairy calves .", "Four disbudding protocols were used on 3 - to 6-week-old Friesian-Jersey calves .", "Farm staff disbudded 101 calves without sedation or local analgesia , of which 51 received 20mg meloxicam S/C .", "Veterinary staff disbudded 101 calves with sedation and local analgesia , of which 51 also received 20mg meloxicam S/C .", "Calves were weighed before disbudding , 15 and 30 days later , and individual milk consumption was recorded for 11 days .", "Daily weight gain and milk consumption were analysed using mixed models and ANOVA .", "From disbudding ( Day 0 ) to Day 15 farmer-disbudded calves receiving meloxicam grew faster ( 0.65 kg/day ) than calves without meloxicam ( 0.55 kg/day ; p = 0.011 ) , but an interaction between operator and meloxicam treatment ( p = 0.056 ) meant that meloxicam treatment did not increase growth rates in veterinary-disbudded calves ( 0.63 vs. 0.64 kg/day ; p = 0.872 ) .", "From Days 16-30 there was no significant effect of meloxicam on growth rate , but veterinarian-disbudded calves grew faster ( 0.76 kg/day ) than farmer-disbudded calves ( 0.66 kg/day ; p = 0.034 ) .", "Overall , for the first 30 days after disbudding , if meloxicam was not used ' , veterinarian-disbudded calves grew faster than farmer-disbudded calves ( p = 0.002 ) .", "However if meloxicam was used at disbudding there was no difference in growth rate between veterinarian - and farmer-disbudded calves ( p = 0.878 ) .", "Mean cumulative milk consumption for the 11 days after disbudding was greater for calves disbudded by veterinary staff than by farm staff ( p < 0.001 ) , but there was no effect of meloxicam treatment ( p = 0.618 ) and no interaction with operator ( p = 0.86 ) on cumulative milk consumption .", "Three to 6-week-old dairy calves disbudded by farm staff with no analgesia grew significantly slower over the next 15 days than farmer-disbudded calves given meloxicam , and slower over the next 30 days than veterinarian-disbudded calves given xylazine and lignocaine .", "However addition of meloxicam to the latter protocol had no effect on growth rate .", "Milk intake was significantly higher for 11 days for veterinarian - compared with farmer-disbudded calves .", "This study adds to the evidence that analgesia during disbudding is beneficial for calf productivity as well as calf welfare ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The double balloon enteroscopy ( DBE ) procedure is long and requires moderate sedation .", "We aim to determine whether the administration of propofol infusion is safe by comparing it to intravenous midazolam/meperidine in patients undergoing DBE .", "A prospective study with 48 patients was conducted at King Chulalongkorn Hospital randomizing ( block of four ) patients into two groups .", "In group 1 , 28 patients were enrolled for intravenous midazolam/meperidine , and one patient was dropped out before underwent DBE due to hemodynamic instability .", "Therefore , 27 ( n = 27 ) participants were included in Group 1 .", "In group 2 , 28 patients were enrolled for propofol infusion , and seven patients were dropped out before underwent DBE , five due to hemodynamic instability ( n = 5 ) , and two refused treatment ( n = 2 ) .", "Therefore , 1 ( n = 21 ) participants were included in Group 2 .", "Vital signs and oxygen saturation were regularly monitored .", "Mean + / - SD age of patients was 56.8 + / - 9.2 years , and 41.7 % of patients were male .", "There was no difference in demographic data between the groups .", "For the safety profile , 25.9 % of the midazolam/meperidine group and 33.3 % of the propofol group developed hypotension and/or desaturation ( p = 0.45 ) .", "The patients ' satisfaction of group 1 and group 2 were 86.7 + / - 6.5 % and 86.3 + / - 8.1 % , respectively , and presented no significant difference ( p = 0.89 ) .", "Propofol infusion is safe and shows no difference in outcome from the midazolam and meperidine sedation for the DBE procedure ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To evaluate the efficacy of cytoflavin in the treatment of patients with hypertensive encephalopathy ( HE ) .", "One hundred and forty patients aged 39 to 73 years , diagnosed with HE , were examined and randomized to 2 groups .", "A study group ( n = 74 ) received cytoflavin in a dose of 2 tablets b.i.d. on days 1 to 25 days inclusive during standard basic therapy .", "A comparison group ( n = 66 persons ) had standard basic therapy only .", "A control group consisted of 30 apparently healthy individuals .", "The investigators studied the frequency of headache , dizziness , and other complaints and the intensity of cephalalgic syndrome , by using a visual analog scale , the quality of life by the Medical Outcomes Study 36-Item Short-Form Health Survey ( MOS SF-36 ) questionnaire , that of sleep by the subjective sleep characteristics questionnaire elaborated at the Moscow City Somnological Center , the level of asthenia by a subjective asthenia rating scale ( Multidimensional Fatigue Inventory ( MFI-20 ) , and autonomic status , by applying objective and subjective scales on days 1 and 25 of therapy .", "The study has shown that cytoflavin used in the above dose for 25 days reduces the frequency and magnitude of complaints of headache , dizziness , `` venous '' complaints , the degree of autonomic and asthenic disorders , and impairments in the quality of sleep and life in the patients with HE at all disease stages .", "A stepwise discriminant analysis has indicated that the degree of cephalgic syndrome , and autonomic disorders , and worse sleep quality are the most effective points for using the energy-modifier cytoflavin .", "HE treatment based on the current pathogenetic principles may have a preventive impact on the development of HE or slow down the rate of its progression ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Local failure after radical prostatectomy ( RP ) is common in patients with cancer extending beyond the capsule .", "Three prospectively randomized trials demonstrated an advantage for adjuvant radiotherapy ( ART ) compared with a wait-and-see ( WS ) policy .", "To determine the efficiency of ART after a 10-yr follow-up in the ARO 96-02 study .", "After RP , 388 patients with pT3 pN0 prostate cancer ( PCa ) were randomized to WS or three-dimensional conformal ART with 60 Gy .", "The present analysis focuses on intent-to-treat patients who achieved an undetectable prostate-specific antigen after RP ( ITT2 population ) -- that is , 159 WS plus 148 ART men .", "The primary end point of the study was progression-free survival ( PFS ) ( events : biochemical recurrence , clinical recurrence , or death ) .", "Outcomes were compared by log-rank test .", "Cox regression analysis served to identify variables influencing the course of disease .", "The median follow-up was 111 mo for ART and 113 mo for WS .", "At 10 yr , PFS was 56 % for ART and 35 % for WS ( p < 0.0001 ) .", "In pT3b and R1 patients , the rates for WS even dropped to 28 % and 27 % , respectively .", "Of all 307 ITT2 patients , 15 died from PCa , and 28 died for other or unknown reasons .", "Neither metastasis-free survival nor overall survival was significantly improved by ART .", "However , the study was underpowered for these end points .", "The worst late sequelae in the ART cohort were one grade 3 and three grade 2 cases of bladder toxicity and two grade 2 cases of rectum toxicity .", "No grade 4 events occurred .", "Compared with WS , ART reduced the risk of ( biochemical ) progression with a hazard ratio of 0.51 in pT3 PCa .", "With only one grade 3 case of late toxicity , ART was safe .", "Precautionary radiotherapy counteracts relapse after surgery for prostate cancer with specific risk factors ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "RESULTS" ]

[ "The aim of this work was to assess the prognostic value of absolute N-terminal-pro-B-type natriuretic peptide ( NT-proBNP ) concentration in combination with changes during admission because of acute heart failure ( AHF ) and early after hospital discharge .", "In AHF , readmission and mortality rates are high .", "Identifying those at highest risk for events early after hospital discharge might help to select patients in need of intensive outpatient monitoring .", "We evaluated the prognostic value of NT-proBNP concentration on admission , at discharge , 1month after hospital discharge and change over time in 309 patients included in the PRIMA ( Can PRo-brain-natriuretic peptide guided therapy of chronic heart failure IMprove heart fAilure morbidity and mortality ? )", "study .", "Primary outcome measures were mortality and the combined end point of heart failure ( HF ) readmission or mortality .", "In a multivariate Cox regression analysis , change in NT-proBNP concentration during admission , change from discharge to 1month after discharge , and the absolute NT-proBNP concentration at 1 month after discharge were of independent prognostic value for both end points ( hazard ratios for HF readmission or mortality : 1.71 , 95 % confidence interval [ CI ] 1.13-2 .60 , Wald 6.4 [ P = .011 ] versus 2.71 , 95 % CI 1.76-4 .17 , Wald 20.5 [ P < .001 ] versus 1.81 , 95 % CI 1.13-2 .89 , Wald 6.1 [ P = .014 ] , respectively .", "Knowledge of change in NT-proBNP concentration during admission because of AHF in combination with change early after discharge and the absolute NT-proBNP concentration at 1 month after discharge allows accurate risk stratification ." ]

[ "OBJECTIVE", "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Three trials demonstrated recently that a long detection window reduces implantable cardioverter-defibrillator ( ICD ) therapy in primary prevention patients .", "Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III ( ADVANCE III ) was the only trial that enrolled both primary and secondary prevention patients .", "Of the 1902 patients enrolled in the ADVANCE III trial , 477 received a defibrillator for secondary prevention ; 248 patients were randomly assigned to a long detection setting ( 30 of 40 intervals ) and 229 to the nominal setting ( 18 of 24 intervals ) for ventricular arrhythmias with cycle length 320 ms. Eight-five percent of patients were men , with a mean age of 65 12 years , a previous history of ventricular fibrillation in 37 % of the cases , and a mean ejection fraction of 38 13 % .", "The ICD device mix was 37 % single chamber , 47 % dual chamber , and 16 % triple chamber .", "Over a median period of 12 months , the long detection period was associated with a 25 % reduction in the number of overall therapies ( 115.6 versus 86.8 per 100 patient-years ; incidence rate ratio , 0.75 ; 95 % confidence interval , 0.61-0 .93 ; P = 0.008 ) and a 34 % reduction in the number of shocks ( rate per 100 patient-years , 51.2 versus 38.1 ; incidence rate ratio , 0.66 ; 95 % confidence interval , 0.48-0 .89 ; P = 0.007 ) .", "Appropriate therapies ( 89.7 versus 67.7 ; incidence rate ratio , 0.77 ; 95 % confidence interval , 0.60-0 .97 ; P = 0.029 ) and appropriate shocks ( 37.1 versus 28.1 ; incidence rate ratio , 0.64 ; 95 % confidence interval , 0.45-0 .93 ; P = 0.018 ) were also reduced .", "ADVANCE III is the first randomized trial to assess a long detection window setting in ICDs in both primary and secondary prevention populations and demonstrates a reduction of overall therapies and shocks in the subgroup of secondary prevention patients .", "These data suggest that even the secondary prevention population may benefit from programming that combines a long detection period with antitachycardia pacing during charging .", "http://www/clinicaltrials.gov .", "Unique identifier : NCT00617175 ." ]

[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "Prospective , double-blind study , randomized control trial .", "To evaluate and compare the analgesic efficacy , adverse effects , and clinical utility of gabapentin and pregabalin in postoperative pain management , long-term functional outcome , and quality of life in patients undergoing spinal surgery .", "Patient outcome after lumbar discectomy for radicular low back pain is variable and the benefit is inconsistent .", "The most common persistent symptoms are pain , motor deficit , and decreased functional status .", "This study was conducted in 90 patients belonging to the 18 to 75 age group of either sex undergoing spinal surgery under general anesthesia .", "Group A received 300 mg of gabapentin , group B received 75 mg of pregabalin , whereas group C received placebo 1 dose 1 hour before surgery and 8 hourly for 7 days , thereafter .", "The outcome of postoperative static and dynamic pain and functional outcome was recorded using 3 questionnaires-visual analogue scale , Prolo functional and economic score , Oswestry Disability Index score from preoperative period to 3 months postoperatively .", "Among the 3 groups , subjects receiving pregabalin showed consistently reduced static and dynamic pain intensity and also required lesser amount of rescue drug throughout the postoperative period .", "There was statistically significant difference ( P < 0.05 ) in the Prolo score and Oswestry Disability Index score at all time intervals between group B and group C. Although , significant difference in the functional outcome between group A and group B was seen at 3 months .", "Preoperative pregabalin administration is associated with less pain intensity and improved functional outcomes 3 months after lumbar discectomy followed by gabapentin and then placebo .", "2 ." ]

[ "METHODS", "OBJECTIVE", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "METHODS" ]

[ "Limited data exist regarding the proarrhythmic effects of smoking .", "To evaluate the relationship between smoking and the risk of first and recurrent ventricular tachyarrhythmias ( VTAs ) in patients with mild heart failure .", "The risk of a first and recurrent appropriate implantable cardioverter-defibrillator therapy for VTAs or death was compared between nonsmokers ( n = 465 ) , past smokers ( n = 780 ) , and current smokers ( n = 197 ) in patients with ischemic and nonischemic cardiomyopathy who were enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy study .", "The cumulative probability of a first VTA or death was significantly higher in current smokers than in past and nonsmokers ( P < .001 ) .", "Multivariate analysis showed that current smokers had a significantly higher risk of first ventricular tachycardia/ventricular fibrillation or death ( hazard ratio [ HR ] 1.51 ; 95 % confidence interval [ CI ] 1.14-2 .01 ; P = .005 ) and a higher risk for first ventricular tachycardia/ventricular fibrillation episode ( HR 1.54 , 95 % CI 1.12-2 .13 , P = .008 ) than did nonsmokers .", "Past smokers had a risk of first VTAs or death similar to that of nonsmokers ( HR 1.01 ; 95 % CI 0.80-1 .27 ; P = .953 ) .", "In comparison to nonsmokers , the risk of recurrent VTAs was significantly higher in the total cohort of patients ( HR 1.54 ; 95 % CI 1.21-1 .95 ; P < .001 ) and in the subgroups of patients with ischemic and nonischemic cardiomyopathy ( HR 1.48 ; 95 % CI 1.03-2 .13 ; P = .035 ) .", "Current smokers with left ventricular dysfunction and mild heart failure are at a significantly higher risk of VTAs or death than are past smokers and nonsmokers .", "Smoking is associated with a significant increase in the risk of recurrent VTAs in both patients with ischemic and nonischemic cardiomyopathy ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Refining leaflet reconstruction has become a primary issue in aortic valve repair .", "This descriptive analysis reviews leaflet pathology , repair techniques , and early results in a prospective regulatory trial of aortic valve repair .", "Sixty-five patients underwent valve repair for predominant moderate to severe aortic insufficiency ( AI ) .", "The mean age was 63 13 years , and 69 % of the patients were male .", "Ascending aortic/root replacement was required in 62 % .", "As a first step , ring annuloplasty was performed , and then leaflet repair included leaflet plication for prolapse , nodular unfolding , double pericardial patching of commissural defects or holes , complete pericardial leaflet replacement , leaflet extension , and Gore-Tex reinforcement .", "Leaflet techniques and causes of adverse outcomes were evaluated .", "The follow-up time was 2-years maximal and 0.9 years mean , with a survival of 97 % .", "Eighty percent of patients required repair of leaflet defects : leaflet prolapse ( 52/65-80 % ) , ruptured commissures ( 6/65 -9 % ) , leaflet holes ( 4/65 -6 % ) , and nodular retraction ( 6/65 -9 % ) .", "The average preoperative AI grade of 2.9 0.8 fell to 0.7 0.7 ( p < 0.0001 ) .", "Three patients ( 4.6 % ) required interval valve replacement because of ( 1 ) suture untying , ( 2 ) iatrogenic leaflet tear , or ( 3 ) diphtheroid endocarditis .", "Five other patients experienced grade 2 or grade 3 AI : probable suture untying in 1patient , ineffective leaflet extensions in 2 patients , and unsuccessful Gore-Tex reinforcements in2patients .", "Two patients with single pericardial leaflet replacements and all those with double pericardial reconstructions did well .", "Leaflet defects are common in patients with moderate to severe AI .", "Leaflet plication , nodular unfolding , and double pericardial patching performed well .", "Gore-Tex and leaflet extension seemed less satisfactory .", "Standardization and experience with leaflet reconstruction will be important for optimizing the outcomes of aortic valve repair ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "We hypothesize that limited transthoracic echocardiogram ( LTTE ) is a useful tool to guide therapy during the initial phase of resuscitation in trauma patients .", "All highest-level alert patients with at least one measurement of systolic blood pressure less than 100 mm Hg , a mean arterial pressure less than 60 mm Hg , and/or a heart rate greater than 120 beats per minute who arrived to the trauma bay ( TB ) were randomized to have either LTTE performed ( LTTEp ) or not performed ( non-LTTE ) as part of their initial evaluation .", "Images were stored , and results were reported regarding contractility ( good vs. poor ) , fluid status ( empty inferior vena cava [ hypovolemic ] vs. full inferior vena cava [ not hypovolemic ] ) , and pericardial effusion ( present vs. absent ) .", "Time from TB to operating room , intravenous fluid administration , blood product requirement , intensive care unit admission , and mortality were examined in both groups .", "A total of 240 patients were randomized .", "Twenty-five patients were excluded since they died upon arrival to the TB , leaving 215 patients in the study .", "Ninety-two patients were in the LTTEp group with 123 patients in the non-LTTE group .", "The LTTEp and non-LTTE groups were similar in age ( 38 years vs. 38.8 years , p = 0.75 ) , Injury Severity Score ( ISS ) ( 19.2 vs. 19.0 , p = 0.94 ) , Revised Trauma Score ( RTS ) ( 5.5 vs. 6.0 , p = 0.09 ) , lactate ( 4.2 vs. 3.6 , p = 0.14 ) , and mechanism of injury ( p = 0.44 ) .", "Strikingly , LTTEp had significantly less intravenous fluid than non-LTTE patients ( 1.5 L vs. 2.5 L , p < 0.0001 ) , less time from TB to operating room ( 35.6 minutes vs. 79.1 min , p = 0.0006 ) , higher rate of intensive care unit admission ( 80.4 % vs. 67.2 % , p = 0.04 ) , and a lower mortality rate ( 11 % vs. 19.5 % , p = 0.09 ) .", "Mortality differences were particularly evident in the traumatic brain injury patients ( 14.7 % in LTTEp vs. 39.5 % in non-LTTE , p = 0.03 ) .", "LTTE is a useful guide for therapy in hypotensive trauma patients during the early phase of resuscitation .", "Therapeutic study , level II ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "METHODS" ]

[ "Our goal is to conduct a multicenter randomized controlled trial ( RCT ) to investigate whether exercise can reduce incident fractures compared with no intervention among women aged 65 years with a vertebral fracture .", "This pilot study will determine the feasibility of recruitment , retention , and adherence for the proposed trial .", "The proposed RCT will be a pilot feasibility study with 1:1 randomization to exercise or attentional control groups .", "Five Canadian sites ( 1 community hospital partnered with an academic center and 4 academic hospitals or centers affiliated with an academic center ) and 2 Australian centers ( 1 academic hospital and 1 center for community primary care , geriatric , and rehabilitation services ) .", "One hundred sixty women aged 65 years with vertebral fracture at 5 Canadian and 2 Australian centers will be recruited .", "The Build Better Bones With Exercise ( B3E ) intervention includes exercise and behavioral counseling , delivered by a physical therapist in 6 home visits over 8 months , and monthly calls ; participants are to exercise 3 times weekly .", "Controls will receive equal attention .", "Primary outcomes will include recruitment , retention , and adherence .", "Adherence to exercise will be assessed via calendar diary .", "Secondary outcomes will include physical function ( lower extremity strength , mobility , and balance ) , posture , and falls .", "Additional secondary outcomes will include quality of life , pain , fall self-efficacy , behavior change variables , intervention cost , fractures , and adverse events .", "Analyses of feasibility objectives will be descriptive or based on estimates with 95 % confidence intervals , where feasibility will be assessed relative to a priori criteria .", "Differences in secondary outcomes will be evaluated in intention-to-treat analyses via independent Student t tests , chi-square tests , or logistic regression .", "The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall alpha level is .05 .", "No assessment of bone mineral density will be conducted .", "The proposed definitive trial will require a large sample size .", "The viability of a large-scale exercise trial in women with vertebral fractures will be evaluated , as well as the effects of a home exercise program on important secondary outcomes ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Abiraterone acetate , an androgen biosynthesis inhibitor , prolongs survival in men with metastatic castration-resistant prostate cancer ( mCRPC ) in the pre - and post-chemotherapy setting as demonstrated by the pivotal phase III studies COU-AA-301 and COU-AA-302 .", "We performed population pharmacokinetic analyses to estimate pharmacokinetic parameters after oral administration of 1,000 mg/day of abiraterone acetate in patients with mCRPC , with or without prior chemotherapy , and after a single 1,000 mg dose in healthy volunteers .", "The study objectives were to determine consistency between patient populations and to characterize factors that may influence abiraterone pharmacokinetics .", "Studies in this analysis included COU-AA-302 ( chemotherapy nave ) ; COU-AA-301 and COU-AA-006 ( chemotherapy pretreated ) ; and COU-AA-008 , COU-AA-009 , and COU-AA-014 ( healthy subjects ) .", "A total of 4,627 plasma concentrations from 359 subjects ( 62 healthy volunteers , 297 patients ) were analyzed using non-linear mixed-effects modeling .", "An Erlang-type absorption model with first-order elimination and three-transit compartments following sequential zero - and first-order processes was used to characterize abiraterone pharmacokinetics .", "Absorption-related parameters were affected by food intake .", "Abiraterone pharmacokinetics were characterized by an extensive apparent clearance , which was lower in patients with mCRPC ( 1,550 L/h ) versus healthy subjects ( 2,240 L/h ) , and by large apparent central ( 5,620 L ) and peripheral ( 17,400 L ) volumes of distribution .", "Abiraterone pharmacokinetics were similar in chemotherapy-pretreated and - nave patients and were characterized by a high between - and within-subject variability [ e.g. , between-subject coefficient of variation ( CV % ) for relative bioavailability for the modified fasting state was 61.1 % and the CV % for within-subject variability was 71.3 % ] .", "The fat content of food taken with abiraterone acetate affected the bioavailability of abiraterone .", "No factors beyond food intake and health status ( healthy vs. mCRPC ) impacted abiraterone pharmacokinetics .", "Based on the pharmacokinetics model , the recommended 1,000 mg/day of abiraterone acetate resulted in similar abiraterone exposure for patients with mCRPC regardless of prior chemotherapy .", "The fat content of food affected relative bioavailability of abiraterone , though the extent of this effect is dependent on health status ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The appropriate caloric goal for critically ill adults is unclear .", "We evaluated the effect of restriction of nonprotein calories ( permissive underfeeding ) , as compared with standard enteral feeding , on 90-day mortality among critically ill adults , with maintenance of the full recommended amount of protein in both groups .", "At seven centers , we randomly assigned 894 critically ill adults with a medical , surgical , or trauma admission category to permissive underfeeding ( 40 to 60 % of calculated caloric requirements ) or standard enteral feeding ( 70 to 100 % ) for up to 14 days while maintaining a similar protein intake in the two groups .", "The primary outcome was 90-day mortality .", "Baseline characteristics were similar in the two groups ; 96.8 % of the patients were receiving mechanical ventilation .", "During the intervention period , the permissive-underfeeding group received fewer mean ( SD ) calories than did the standard-feeding group ( 835297 kcal per day vs. 1299467 kcal per day , P < 0.001 ; 4614 % vs. 7122 % of caloric requirements , P < 0.001 ) .", "Protein intake was similar in the two groups ( 5724 g per day and 5925 g per day , respectively ; P = 0.29 ) .", "The 90-day mortality was similar : 121 of 445 patients ( 27.2 % ) in the permissive-underfeeding group and 127 of 440 patients ( 28.9 % ) in the standard-feeding group died ( relative risk with permissive underfeeding , 0.94 ; 95 % confidence interval [ CI ] , 0.76 to 1.16 ; P = 0.58 ) .", "No serious adverse events were reported ; there were no significant between-group differences with respect to feeding intolerance , diarrhea , infections acquired in the intensive care unit ( ICU ) , or ICU or hospital length of stay .", "Enteral feeding to deliver a moderate amount of nonprotein calories to critically ill adults was not associated with lower mortality than that associated with planned delivery of a full amount of nonprotein calories .", "( Funded by the King Abdullah International Medical Research Center ; PermiT Current Controlled Trials number , ISRCTN68144998 . )" ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Lobeglitazone , a peroxisome proliferator-activated receptor - agonist , is metabolized primarily by the cytochrome P450 ( CYP ) 3A4 isoenzyme .", "Individuals concomitantly taking lobeglitazone and a CYP3A4 inhibitor may experience some adverse effects secondary to increased systemic exposure to lobeglitazone .", "To address such potential concern , we evaluated the effects of ketoconazole , a prototypic CYP3A4 inhibitor , on the pharmacokinetic ( PK ) properties and associated adverse effects of lobeglitazone .", "A PK drug-drug interaction study was conducted in healthy individuals between 20 and 45 years old in a randomized , open-label , 2-way crossover design .", "Even though the PK study was performed on a single dose of lobeglitazone , multiple ketoconazole doses were given to ensure that the full extent of inhibition of CYP3A4 was maintained during the PK sampling .", "All study participants received a single oral dose of lobeglitazone 0.5 mg with or without 9 oral 200-mg doses of ketoconazole pretreatment twice daily .", "The primary PK parameter end points ( AUC and Cmax ) were estimated using noncompartmental analysis , and the 90 % CIs for the geometric mean ratios ( ratio of lobeglitazone and ketoconazole to lobeglitazone alone ) were investigated .", "Tolerability ( adverse events , vital signs , ECG , and laboratory tests ) was also assessed .", "A total of 24 Korean men ( mean age , 26 years ; age range , 20-32 years ; mean weight , 68 kg ; weight range , 59-81 kg ) completed the study and were evaluable for lobeglitazone PK properties and tolerability .", "The mean ( SD ) Cmax values of lobeglitazone with and without ketoconazole were 49 ( 7 ) ng/mL and 48 ( 6 ) ng/mL at 1.5 and 1.0 hours after dosing , respectively .", "The mean ( SD ) AUC values were 532 ( 117 ) ngh/mL and 405 ( 110 ) ngh/mL , respectively .", "Although the Cmax was not significantly affected , the geometric mean ratio for AUC was increased by a point estimate of 1.33 ( 90 % CI , 1.23-1 .44 ) .", "A single oral administration of lobeglitazone 0.5 mg with or without ketoconazole pretreatment did not produce any clinically significant adverse effects on vital signs , 12-lead ECG profiles , or laboratory tests .", "The administration of lobeglitazone , 0.5 mg alone or in combination with multiple doses of ketoconazole , was generally well tolerated .", "The systemic exposure of lobeglitazone was increased to a modest extent by pretreatment with 9 twice-daily doses of ketoconazole .", "Clinicaltrials.gov identifier : NCT01330563 ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Survivin is a member of the inhibitor-of-apoptosis family .", "Essential for tumor cell survival and overexpressed in most cancers , survivin is a promising target for anti-cancer immunotherapy .", "Immunogenicity has been demonstrated in multiple cancers .", "Nonetheless , few clinical trials have demonstrated survivin-vaccine-induced immune responses .", "This phase I trial was conducted to test whether vaccine EMD640744 , a cocktail of five HLA class I-binding survivin peptides in Montanide ( ) ISA 51 VG , promotes anti-survivin T-cell responses in patients with solid cancers .", "The primary objective was to compare immunologic efficacy of EMD640744 at doses of 30 , 100 , and 300 g. Secondary objectives included safety , tolerability , and clinical efficacy .", "In total , 49 patients who received 2 EMD640744 injections with available baseline - and 1 post-vaccination samples [ immunologic-diagnostic ( ID ) - intention-to-treat ] were analyzed by ELISpot - and peptide/MHC-multimer staining , revealing vaccine-activated peptide-specific T-cell responses in 31 patients ( 63 % ) .", "This cohort included the per study protocol relevant ID population for the primary objective , i.e. , T-cell responses by ELISpot in 17 weeks following first vaccination , as well as subjects who discontinued the study before week 17 but showed responses to the treatment .", "No dose-dependent effects were observed .", "In the majority of patients ( 61 % ) , anti-survivin responses were detected only after vaccination , providing evidence for de novo induction .", "Best overall tumor response was stable disease ( 28 % ) .", "EMD640744 was well tolerated ; local injection-site reactions constituted the most frequent adverse event .", "Vaccination with EMD640744 elicited T-cell responses against survivin peptides in the majority of patients , demonstrating the immunologic efficacy of EMD640744 ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Physiotherapy is integral to modern trauma care .", "Early physiotherapy and mobility have been shown to improve outcomes in patients with isolated injuries ; however , the optimal intensity of physiotherapy in the multitrauma patient population has not yet been examined .", "The primary aim of this study was to determine whether an intensive physiotherapy program resulted in improved inpatient mobility .", "We conducted a single-center prospective randomized controlled study of 90 consecutive patients admitted to the Alfred Hospital ( a Level 1 trauma center ) in Australia between October 2011 and June 2012 who could participate in ward-based physiotherapy .", "Participants were allocated to either usual care ( daily physiotherapy treatment , approximately 30 minutes ) or intensive physiotherapy ( usual care plus two additional 30-minute treatments each day ) .", "The primary outcome measure was the modified Iowa Level of Assistance ( mILOA ) score , collected by a blinded assessor at Days 3 and 5 ( or earlier if discharged ) .", "Secondary measures included physical readiness for discharge , hospital and rehabilitation length of stay , a patient confidence and satisfaction scale , and quality of life at 6 months .", "Groups were comparable at baseline .", "Participants in the intensive physiotherapy group achieved significantly improved mILOA scores on Day 3 ( median , 7 points compared with 10 points ; p = 0.02 ) and Day 5 ( median , 7.5 points compared with 16 points ; p = 0.04 ) and were more satisfied with their care ( p = 0.01 ) .", "There was no difference between groups in time to physical readiness , discharge destination , length of stay , or quality-of-life measures .", "Intensive physiotherapy resulted in improved mobility in trauma inpatients .", "Further studies are required to determine if specific groups benefit more from intensive physiotherapy and if this translates to long-term improvements in outcomes .", "Therapeutic study , level 1 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "METHODS" ]

[ "Uncertainty may limit communication and affect the ability of patients to adapt to their illness .", "A high level of uncertainty in patients concurrent with sudden hearing loss has been related to poor comprehension of communications and poor illness understanding .", "Currently , there is no any certain standard information sheet in the clinical setting .", "This study evaluates the effect of a one-to-one oral instruction strategy combined with an information sheet firstly on the stimuli frame and then on uncertainty in patients suffering from idiopathic sudden sensorineural hearing loss .", "An experimental design was employed and 60 patients were randomly assigned to either the experimental group ( n = 28 ) or the control group ( n = 32 ) .", "A structured questionnaire that included the stimuli frame of uncertainty and the Mishel uncertainty illness scale was used to collect data .", "All samples received regular care following admission to the hospital and received the pretest within 24 hours after admission .", "The experimental group received the one-to-one oral instruction strategy combined with an information sheet immediately after the pretest .", "All participants completed the posttest three days later .", "The health education program increased perceived understanding of illness in patients with the sudden hearing loss , and reduced their illness uncertainty .", "Perceived understanding of illness was negatively related to the level of illness uncertainty .", "The stimuli frame of uncertainty acted as a mediator between the intervention and the uncertainty .", "The intervention increased the level of cognition of the stimuli frame of uncertainty and then indirectly lowered the uncertainty level .", "These findings support the effectiveness of the individual health education strategy with the information sheet in delivering to patients critical information about their condition and treatment .", "Moreover , this intervention may effectively increase illness cognition and reduce uncertainty in patients with sudden hearing loss .", "Clinical nurse staffs may use the findings of this study to improve their health education efficacy ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Preterm labor and delivery are of the most important complications of pregnancy and have a major role in neonatal mortality and morbidity .", "Management of preterm labor and prevention from preterm delivery in order to lower these risks have always been under serious concern .", "The purpose of this study was to compare the effect of nifedipine and nitroglycerin ( NG ) dermal patch for taking control of preterm labor .", "The study was performed as a randomized clinical trial on women who had been admitted in the hospital diagnosed with preterm labor .", "In one group , the NG dermal patch and in the other group , nifedipine was prescribed .", "Then the women of the two groups were followed up to delivery and were compared according to arrest of labor for 2h , 48h , 7 days , gestational age at the time of delivery and their adverse effects .", "The primary outcome was to postpone delivery for 48h in order to have enough time for prescribing corticosteroids", "The women of the two groups did not have any significant difference according to age , body mass index , primary Bishop Score , gestational age at the time of tocolytic therapy , history of abortion , vaginal or cesarean delivery and preterm labor .", "In more women in the NG group , delivery was postponed for 2h ( 59 ( 98.3 % ) vs 48 ( 80 % ) , P = 0.001 ) , for 48h ( 52 women ( 86.7 % ) vs 41 ( 68.3 % ) , P = 0.016 ) and also for 7 days ( 47 ( 78.3 % ) vs 37 ( 61.7 % ) , P = 0.046 ) , than the women in the nifedipine group .", "Gestational age at the time of delivery was higher in the NG group ( 35.61.9 vs 34.32.05 weeks , P = 0.155 ) , however , it was not statistically significant .", "Apgar score of minute 5 , ( P = 0.03 ) and neonatal weight ( P = 0.04 ) , were more and cesarean deliveries , neonatal intensive care unit ( NICU ) admission and duration of NICU stay were less in the NG group .", "Adverse effects were similar , minimal and negligible in both groups .", "The NG patch is a more effective method for preterm labor control than nifedipine with regard to minimal side effects ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To determine whether incubation in the integrated EmbryoScope time-lapse monitoring system ( TMS ) and selection supported by the use of a multivariable morphokinetic model improve reproductive outcomes in comparison with incubation in a standard incubator ( SI ) embryo culture and selection based exclusively on morphology .", "Prospective , randomized , double-blinded , controlled study .", "University-affiliated private invitro fertilization ( IVF ) clinic .", "Eight hundred forty-three infertile couples undergoing intracytoplasmic sperm injection ( ICSI ) .", "No patient intervention ; embryos cultured in SI with development evaluated only by morphology ( control group ) and embryos cultured in TMS with embryo selection was based on a multivariable model ( study group ) .", "Rates of embryo implantation , pregnancy , ongoing pregnancy ( OPR ) , and early pregnancy loss .", "Analyzing per treated cycle , the ongoing pregnancy rate was statistically significantly increased 51.4 % ( 95 % CI , 46.7-56 .0 ) for the TMS group compared with 41.7 % ( 95 % CI , 36.9-46 .5 ) for the SI group .", "For pregnancy rate , differences were not statistically significant at 61.6 % ( 95 % CI , 56.9-66 .0 ) versus 56.3 % ( 95 % CI , 51.4-61 .0 ) .", "The results per transfer were similar : statistically significantdifferences in ongoing pregnancy rate of 54.5 % ( 95 % CI , 49.6-59 .2 ) versus 45.3 % ( 95 % CI , 40.3-50 .4 ) and not statisticallysignificantfor pregnancy rate at 65.2 % ( 95 % CI , 60.6-69 .8 ) versus 61.1 % ( 95 % CI , 56.2-66 .1 ) .", "Early pregnancy loss wasstatistically significantly decreased for the TMS group with 16.6 % ( 95 % CI , 12.6-21 .4 ) versus 25.8 % ( 95 % CI , 20.6-31 .9 ) .", "The implantation rate was statistically significantly increased at 44.9 % ( 95 % CI , 41.4-48 .4 ) versus 37.1 % ( 95 % CI , 33.6-40 .7 ) .", "The strategy of culturing and selecting embryos in the integrated EmbryoScope time-lapse monitoring system improves reproductive outcomes .", "NCT01549262 ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "Once the diagnosis of Helicobacter pylori is confirmed , treatment requires at least two antibiotics and an acid inhibitor for a minimum of seven days .", "Unfortunately , treatment failures are being frequently reported .", "Treatment regimens that include sequential administration of antibiotics with acid inhibitors have been developed to try and increase the rate of eradication .", "To determine the effectiveness of a novel 10-day sequential therapy compared with the standard 10-day triple therapy for treatment of H. pylori infection in children .", "A double-blinded , randomised , controlled trial was conducted .", "Children under the age of 16 years with recurrent abdominal pain associated with dyspepsia and diagnosed with H. pylori by histology were randomly allocated either to a 10-day sequential treatment regimen or to a 10-day conventional triple therapy .", "Analysis of the outcome of this study was based on clinical improvement and confirmed H. pylori eradication based on stool H. pylori antigen detection and/or repeat endoscopy .", "Of the 71 patients included in the analysis , 45 ( 63.4 % ) were given the 10-day conventional treatment while 26 ( 36.6 % ) received the 10-day sequential treatment .", "There was no difference in clinical improvement after treatment in the two therapies .", "However , there was a significant difference in the eradication of H. pylori between the conventional v. sequential regimens ( 48.8 % v. 84.6 % , respectively ; p = 0.02 , odds ratio 0.19 ) .", "The sequential treatment had a significantly higher H. pylori eradication rate than the conventional treatment ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Wavefront-guided ( WFG ) and wavefront-optimized ( WFO ) platforms for refractive surgery are designed for improved visual outcomes .", "It is unclear which treatment profile is superior for patients undergoing photorefractive keratectomy ( PRK ) .", "To compare the safety , efficacy , predictability , stability , and higher-order aberrations in eyes undergoing WFG and WFO PRK .", "A prospective , randomized , fellow-eye-controlled clinical trial was conducted at the Byers Eye Institute at Stanford with enrollment between April 2009 and March 2011 ; 1 year of follow-up was included .", "Of 90 patients screened , 71 patients ( 142 eyes ) with less than 12.00 diopters ( D ) of spherical myopia and less than 3.00 D of astigmatism were enrolled consecutively .", "One eye was randomized to undergo WFG PRK treatment ( Visx CustomVue Star S4 IR excimer laser system ; Abbott Medical Optics ) , and the fellow eye received WFO PRK treatment ( WaveLight Allegretto Wave Eye-Q 400 Hz excimer laser system ; Alcon Surgical ) .", "Data on the manifest refraction , uncorrected visual acuity , best-corrected visual acuity , 5 % and 25 % contrast best-corrected visual acuity , and higher-order aberrations were collected preoperatively and at the 1 - , 3 - , 6 - , and 12-month follow-up visits .", "Eyes undergoing both treatments had improved best-corrected visual acuity ( WFG : mean , 0.05 [ 95 % CI , 0.03-0 .07 ] ; WFO : mean , 0.04 [ 95 % CI , 0.02-0 .06 ] ) and less sphere ( WFG : mean , -4.79 [ 95 % CI , -5.31 to -4.26 ] ; WFO : mean , -4.61 [ 95 % CI , -5.18 to -4.03 ] ) , cylinder ( WFG : mean , 0.66 [ 95 % CI , 0.49-0 .82 ] ; WFO : mean , 0.52 [ 95 % CI , 0.35-0 .69 ] ) , and spherical equivalents ( WFG : mean , -4.45 [ 95 % CI , -4.99 to -3.91 ] ; WFO : mean , -4.34 [ 95 % CI , -4.92 to -3.76 ] ) ( P < .001 ) but higher levels of spherical aberration ( WFG : mean , -0.11 [ 95 % CI , -0.15 to -0.06 ] ; WFO : mean , -0.11 [ 95 % CI , -0.14 to -0.07 ] ) ( P < .001 ) and higher-order root-mean-square aberrations ( WFO : mean , -0.07 [ 95 % CI , -0.12 to -0.02 ] ; WFO : mean , -0.12 [ 95 % CI , -0.17 to -0.70 ] ) ( P = .005 in WFG eyes and P < .001 in WFO eyes ) at 12 months compared with preoperative measurements .", "A total of 93.0 % of the eyes in the WFG group and 94.4 % in the WFO had an uncorrected visual acuity of 20/20 or better at 12 months , with 56.3 % in the WFG group and 43.7 % in the WFO group gaining 1 or more lines of best-corrected visual acuity .", "The stability of the refractive correction was excellent for both groups .", "A difference in uncorrected visual acuity or contrast acuity between eyes undergoing WFG or WFO treatment at 3 months and beyond could not be identified .", "This lack of difference suggests that both systems can be used to provide excellent improvement in vision for persons with myopia .", "clinicaltrials.gov Identifier : NCT01135719 ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "This study investigated the short-term efficacy of low-level laser therapy ( LLLT ) in patients with mild to moderate carpal tunnel syndrome ( CTS ) , lasting for < 1 year .", "Seventy-nine patients with CTS were included in this double-blind , placebo-controlled study , and randomly divided in two treatment groups : Experimental group ( EG ) , active laser group ( 40 patients ) ; and control group ( CG ) , placebo ( sham ) laser group ( 39 patients ) .", "A GaAlAs diode laser [ 780 nm , 30 mW continuous wave ( CW ) , 0.785 cm ( 2 ) , 38.2 mW/cm ( 2 ) ] was applied in contact with four points perpendicularly to the skin over the carpal tunnel area for 90 sec per point ( 2.7 J , 3.4 J/cm ( 2 ) / point ) .", "Both groups were treated five times per week , once a day over 2 weeks , followed by 10 treatments every other day for 3 weeks , that is , for a total of 20 treatments .", "Clinical assessment , including visual analogue scale ( VAS ) pain rating , Tinel 's sign , and median nerve conduction studies ( NCSs ) were evaluated before , and 3 weeks after , the last LLLT treatment .", "Significant reduction in pain , reduction in the percentage of patients with a positive Tinel 's sign , and shortening of sensory and motor latency time in the NCS examination was observed in the experimental LLLT group ( but not in the control group ) .", "This study has observed and documented the statistically significant short-term effects of LLLT on CTS patients in comparison with a placebo group .", "The results support this conclusion , especially if the LLLT is applied in the earlier stages of CTS , and with mild to moderate cases ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To compare dentin tubule occlusion by dentifrices containing either nanohydroxyapatite ( 10 % nHAP and 15 % nHAP ) , sodium monofluorophosphate ( Na-MFP ) or NovaMin ( NovaMin ) .", "All 80 participants wore four intraoral appliances bearing dentin blocks while using one of the four test dentifrices ( n = 20/dentifrice ) twice daily for 14 days .", "The four appliances were removed in pairs after 7 and 14 days .", "One treated block from each of the test periods ( 7 and 14 days ) and their untreated controls were examined with SEM to determine the level of tubule occlusion .", "The remaining two treated blocks and their controls were used to determine tubule permeability to dye solution .", "Effectiveness was compared statistically ( ANOVA/Tukey 's ) based on % area covered by deposited precipitate layer ( % DPL ) , % dye penetration inhibition ( % DPI ) and percentage of fully-open ( % FOT ) , partially-occluded ( % POT ) and completely-occluded ( % COT ) tubules in each block calculated relative to the number of tubules in their control blocks .", "SEM showed increased % COT and % DPL overtime .", "After 7 and 14 days , % COT , % POT , % DPL and % DPI were significantly lower with Na-MFP when compared to 10 % nHAP ( P < 0.01 ) , NovaMin ( P < 0.05 ) and 15 % nHAP ( P < 0.001 ) , the three of which were not significantly different from each other in those four variables .", "A reverse trend was observed with % FOT ( P < 0.001 ) .", "Within the same dentifrice , no difference in % COT , % POT , % FOT , % DPI and % DPL after 7 and 14 days , except with Na-MFP in which % DPL significantly ( P < 0.05 ) increased with usage .", "In conclusion , nanohydroxyapatite-containing and NovaMin-containing toothpastes showed equal and more effectiveness in occluding dentin tubules than Na-MFP toothpaste ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS" ]

[ "Imiquimod 3.75 % and 2.5 % creams were studied for the treatment of actinic keratosis ( AK ) of the full face or balding scalp , to determine comparable efficacy and tolerability to imiquimod 5 % cream .", "In two identical multicenter , randomized , double-blind , placebo controlled studies .", "Adult subjects with 5 to 20 visible lesions , or palpable AKs in an area that exceeded 25 cm on either the face or balding scalp were randomized to imiquimod 3.75 % , 2.5 % or vehicle cream ( 1:1:1 ) applied once daily for two 2-week treatment cycles , with a 2-week , no-treatment interval between cycles .", "Efficacy was assessed 8 weeks posttreatment ( End of Study Visit [ EOS ] ) .", "Primary efficacy was rate of complete clearance of AK lesions .", "Secondary efficacy endpoints were rate of partial clearance at EOS ( 75 % reduction in number of AK lesions compared to baseline ) and median percent decrease from baseline lesion count .", "Safety assessments included visual assessment of local skin reactions ( LSRs ) , number and duration of study treatment rest periods required due to intolerant LSRs , adverse events ( AEs ) and clinical laboratory tests .", "Overall 479 patients were randomized to imiquimod 3.75 % , 2.5 % , or vehicle .", "Complete clearance rates were 35.6 % , 30.6 % , and 6.3 % respectively ( both P < .001 versus vehicle ) .", "The difference in complete clearance rates ( imiquimod minus vehicle ) was 29.3 % and 24.3 % , respectively .", "Partial clearance rates were 59.4 % , 48.1 % , and 22.6 % respectively ( both P < .001 versus vehicle ) .", "Median % reductions in AK lesions were 81.8 % , 71.8 % , and 25.0 % respectively ( P < .001 versus vehicle ) .", "All primary and secondary efficacy endpoints were greater in Study 1 .", "Photodamage in the treatment area was ` much improved ' with imiquimod 3.75 % .", "Both active creams were well tolerated with few treatment-related discontinuations .", "In two well-controlled Phase 3 studies , both imiquimod 3.75 % and 2.5 % creams were more effective than vehicle and well tolerated when administered daily as a 2-week on/off/on regimen to treat AK .", "Reduction in AK lesions was comparable to that reported with imiquimod 5 % with fewer local AEs ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Cannabis is the most consumed illegal substance in France .", "General practitioners ( GPs ) are the health professionals who are most consulted by adolescents .", "Brief intervention ( BI ) is a promising care initiative for the consumption of cannabis , and could be a tool for GPs in caring for adolescents who consume cannabis .", "The aim of the CANABIC study is to measure the impact of a BI carried out by a GP on the consumption of cannabis by adolescents of 15 to 25years of age .", "A randomized clustered controlled trial , stratified over three areas ( Auvergne , Languedoc-Roussillon , and Rhne - Alpes ) , comparing an intervention group , which carries out the BI in consultation , and a control group , which ensures routine medical care .", "The main assessment criterion is the consumption of cannabis by amount of joints per month , at 12months .", "The amount necessary to highlight a significant difference between the two groups of 30 % of consumption at 12months is 250 patients ( 50 GPs , 5 patients per GP ; risk = 5 % ; power = 90 % ; intra-cluster correlation coefficient = 0.2 ; Hawthorne effect = 15 % ; lost to follow-up rates for GPs = 10 % and for patients = 20 % ) .", "This plan is replicated for the three areas , and therefore a total of 750 patients are expected.The secondary criteria for judgment are the associated consumption of tobacco and alcohol , the perception of the consequences of consumption , and the driving of a vehicle following consumption .", "Research about BI for young cannabis users is underway .", "The aim of the CANABIC study is to validate a BI suited to adolescents who consume cannabis , which may be performed in the general practice .", "This would provide a tool for their treatment by a GP , which could be widely distributed during initial or further medical training .", "CANABIC is a randomized clustered trial ( NCT01433692 , registered 2011 Sept 12 ) , PHRC funded : Clinical Research Hospital Program ( Governmental Fund , Health Ministry ) .", "Date first patient randomized : March 2012 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "To evaluate the safety and effect of L-carnitine combined with tadalafil in the treatment of late-onset hypogonadism ( LOH ) with erectile dysfunction ( ED ) .", "We randomly divided 140 cases of LOH with ED aged 40 -70 years into a treatment and a control group to receive L-carnitine + tadalafil and testosterone undecanoate + tadalafil , respectively .", "After 8 weeks of treatment , we obtained the scores on IIEF-5 and Aging Male Symptoms ( AMS ) , observed changes in the levels of sex hormones , analyzed the results of the routine blood test and PSA level , and evaluated the safety of medication .", "Finally , 110 cases were included , 60 in the treatment group and 50 in the control .", "After 8 weeks of medication , the IIEF-5 and AMS scores were significantly improved as compared with the baseline both in the treatment group ( 17.7 + / - 3.5 vs 10.2 + / - 2.7 and 36.2 + / - 6.5 vs 48.8 + / - 5.8 ) and in the control group ( 16.7 + / - 2.6 vs 9.3 + / - 2.4 and 35.8 + / - 6.6 vs 50.7 + / - 5.0 ) ( both P < 0.05 ) , with no significant differences between the two groups ( P > 0.05 ) .", "As for the safety of medication , there were no significant differences between the two groups before and after treatment ( P > 0.05 ) .", "Two patients in the control group showed a PSA level > 4 microg/L , which was confirmed to be caused by prostatitis during follow-up .", "L-carnitine combined with tadalafil is safe and effective for the treatment of LOH with ED ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "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 .", "However , it might be warranted in patients destined to undergo vigorous physical therapy .", "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 .", "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 .", "All participants were screened for serious cardiovascular and pulmonary conditions .", "At six-weeks poststroke , they also completed a cardiovascular screening inventory and underwent an exercise tolerance test involving bicycle ergometry .", "Participants received 36 , 90-min sessions of a prescribed physical therapy ( three per week ) , initiated at either two-months or six-months poststroke .", "Twenty-nine participants were excluded on the basis of the cardiac screening questionnaire , and 15 failed the exercise tolerance test for cardiovascular reasons .", "No participant experienced a cardiac event during a treatment session .", "Two participants experienced myocardial infarctions , but continued in the trial .", "In three additional participants , myocardial infarctions caused or contributed to death .", "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 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]