Compared with patients with commercial insurance , those with no insurance or with public coverage had greater recovery from depression symptoms with collaborative care than with usual care over the 18-month follow-up period .


At the 12-month follow-up , the effect size for depression improvement compared with usual care among women with no insurance or with public coverage was 0.81 ( 95 % CI = 0.41 , 0.95 ) , whereas it was 0.39 ( 95 % CI = -0.08 , 0.84 ) for women with commercial insurance .


Collaborative depression care adapted to obstetrics-gynecology settings had a greater impact on depression outcomes for socially disadvantaged women with no insurance or with public coverage compared with women with commercial insurance .


To assess the applicability of the Peak Nasal Inspiratory Flow ( PNIF ) curves in follow-up of children in the treatment of allergic rhinitis .


Prospective study of 40 patients with AR , grouped in corticosteroid spray versus physiological saline solution use .


Follow up for 10 weeks through clinical score and PNIF percentages in relation to the reference curves , with was-out at week 8 .


Statistical assessment of the effect of treatment on variation of PNIF and clinical score was calculated by ANOVA model and Multiple Comparison of Means Test - Least Significant Difference .


There was a statistically significant influence of the group , time and interaction between time and group on PNIF percentages .


Throughout follow up , patients from the treatment group had mean PNIF percentages significantly higher than the placebo group .


Clinical score results also demonstrated a statistically significant influence between the groups , time and interaction between time and group .


Increase in PNIF percentage values observed in children treated with intranasal corticosteroids revealed the applicability of PNIF curves in their follow up .


Regular maternal exercise may play an important role in the management of gestational diabetes mellitus ( GDM ) , yet specific exercise guidelines to achieve glycemic control have not been established .


Furthermore , many women remain sedentary during pregnancy because of perceived barriers to exercise participation .


This study examined the effectiveness of a home-based cycling program commenced upon diagnosis of GDM on daily fasting and postprandial blood glucose levels , glycosylated hemoglobin ( HbA1c ) , and the response of glucose and insulin to a 75-g oral glucose load .


Forty sedentary women ( 28.8 0.9 wk of gestation ) were randomized to either home-based exercise training in combination with conventional management ( EX , n = 20 ) or to conventional management alone ( CON , n = 20 ) until week 34 of pregnancy .


Mean compliance to the supervised exercise training was 96 % , and no adverse effects were reported .


Capillary glucose concentration was acutely reduced in response to each cycling session ( 6.3 0.8 mM to 4.9 0.7 mM , P < 0.001 ) .


Overall , the EX group had lower mean daily postprandial glucose concentrations throughout the intervention compared with that in the CON group ( P < 0.05 ) despite consuming a greater proportion of dietary carbohydrate ( P < 0.05 ) .


No differences were observed between groups with respect to HbA1c or the glucose and insulin response to oral glucose ingestion postintervention ( P > 0.05 ) .


A home-based cycling program may help to maintain daily postprandial normoglycemia in women with diet-controlled GDM .


It is necessary to screen people at high risk for proteinuria with an economical , reliable and convenient method .


The aim of this study is to establish a new approach to predict 24h urine protein ( 24h UP ) by routine laboratory assays .


Five centres were included and a total of 4211 hospitalized patients were enrolled .


All samples were assayed for dipstick protein ( DSP ) , specific gravity ( SG ) , 24h UP and serum albumin ( ALB ) simultaneously .


4211 patients were randomly divided into two groups for establishing and testing the equations .


Equations were built by multiple log-linear regressions .


( i ) DSP is significantly correlated to 24h UP in a logarithmic pattern ; ( ii ) SG interprets 24h UP for specific DSP ; ( iii ) Equation 1 = 0.20310 ( dummy-variable F ) [ 100 ( SG-1 ) ] ( -0.470 ) ; and ( iv ) Equation 2 = 13.36610 ( dummy-variable F ) [ 100 ( SG-1 ) ] ( -0.547 ) [ ALB ( g/L ) ] ( -1.130 ) The dummy-variable F had a point-to-point accordance to DSP ( detailed in text ) .


Combination of DSP and SG can interpret normal-range proteinuria well , and helped by ALB , their interpretation for macro proteinuria is much improved .


It is dependable and economical for routine urinalysis to evaluate pathological proteinuria by equation .


The purpose of this study was to compare the effects of two different resistance exercise protocols on self-reported disability , fear avoidance beliefs , pain catastrophizing , and back pain symptoms in obese , older adults with low back pain ( LBP ) .


Obese adults ( n = 49 , 60-85 yr ) with chronic LBP were randomized into a total body resistance exercise intervention ( TOTRX ) , lumbar extensor exercise intervention ( LEXT ) , or a control group ( CON ) .


Main outcomes included perceived disability ( Oswestry Disability Index , Roland Morris Disability Questionnaire ) .


Psychosocial measures included the Fear Avoidance Beliefs survey , Tampa Scale of Kinesiophobia , and Pain Catastrophizing Scale .


LBP severity was measured during three functional tasks : walking , stair climbing , and chair rise using an 11-point numerical pain rating scale .


The TOTRX group had greater reductions in self-reported disability scores due to back pain ( Oswestry Disability Index , Roland Morris Disability Questionnaire ) compared with those in the LEXT ( P < 0.05 ) .


The Pain Catastrophizing Scale scores decreased in the TOTRX group compared with that in the CON group by month 4 ( 64.3 % vs 4.8 % , P < 0.05 ) .


Pain severity during chair rise activity and walking was decreased in both the LEXT and TOTRX groups relative to the CON group .


Greater reductions in perceived disability due to LBP can be achieved with TOTRX compared with those achieved with LEXT .


Pain catastrophizing and pain severity decreased most with TOTRX .


The positive change in psychological outlook may assist obese , older adults with chronic back pain in reconsidering the harmfulness of the pain and facilitate regular participation in other exercise programs .


Suboptimal vitamin B status might affect cognitive performance in early childhood .


We tested the hypothesis that short-term supplementation with folic acid and selected B vitamins improves cognitive function in healthy children in a population with relatively low folate status .


We screened 1,002 kindergarten children for suboptimal folate status by assessing the total urinary para-aminobenzoylglutamate excretion .


Two hundred and fifty low ranking subjects were recruited into a double blind , randomized , controlled trial to receive daily a sachet containing 220 g folic acid , 1.1 mg vitamin B2 , 0.73 mg B6 , 1.2 g B12 and 130 mg calcium , or calcium only for 3 months .


Primary outcomes were changes in verbal IQ , short-term memory and processing speed between baseline and study end .


Secondary outcomes were urinary markers of folate and vitamin B12 status , acetyl-para-aminobenzoylglutamate and methylmalonic acid , respectively , and , in a subgroup of 120 participants , blood folate and plasma homocysteine .


Pre - and post-intervention cognitive measurements were completed by 115 children in the intervention and 122 in the control group .


Compared to control , median blood folate increased by about 50 % ( P for difference , P < 0.0001 ) .


Homocysteine decreased by 1.1 mol/L compared to baseline , no change was seen in the control group ( P for difference P < 0.0001 ) and acetyl-para-aminobenzoylglutamate was 4 nmol/mmol higher compared to control at the end of the intervention ( P < 0.0001 ) .


We found no relevant differences between the groups for the cognitive measures .


Short-term improvement of folate and homocysteine status in healthy children does not appear to affect cognitive performance .


In 2005 the American College of Surgeons passed a mandate requiring that level I trauma centers have mechanisms to identify and intervene with problem drinkers .


The aim of this investigation was to determine if a multi-level trauma center intervention targeting both providers and patients would lead to higher-quality alcohol screening and brief intervention ( SBI ) when compared with trauma center mandate compliance without implementation enhancements .


Cluster randomized trial in which intervention site ( site n = 10 , patient n = 409 ) providers received 1-day workshop training on evidence-based motivational interviewing ( MI ) alcohol interventions and four 30-minute feedback and coaching sessions ; control sites ( site n = 10 , patient n = 469 ) implemented the mandate without study team training enhancements .


Trauma centers in the United States of America .


A total of 878 blood alcohol-positive in-patients with and without traumatic brain injury ( TBI ) .


MI skills of providers were assessed with fidelity coded standardized patient interviews .


All patients were interviewed at baseline and 6 - and 12-months post-injury with the Alcohol Use Disorders Identification Test ( AUDIT ) .


Intervention site providers consistently demonstrated enhanced MI skills compared with control providers .


Intervention patients demonstrated an 8 % reduction in AUDIT hazardous drinking relative to controls over the course of the year after injury ( relative risk = 0.88 , 95 % , confidence interval = 0.79 , 0.98 ) .


Intervention patients were more likely to demonstrate improvements in alcohol use problems in the absence of traumatic brain injury ( TBI ) ( P = 0.002 ) .


Trauma center providers can be trained to deliver higher-quality alcohol screening and brief intervention ( SBI ) than untrained providers , which is associated with modest reductions in alcohol use problems , particularly among patients without TBI .


Our group previously showed that colchicine treatment is associated with decreased early recurrence rate after ablation for atrial fibrillation ( AF ) .


The purpose of this study was to test the mid-term efficacy of colchicine in reducing AF recurrences after a single procedure of pulmonary vein isolation in patients with paroxysmal AF .


Assessment of quality-of-life ( QOL ) changes was a secondary objective .


Patients with paroxysmal AF who were scheduled for ablation were randomized to a 3-month course of colchicine 0.5 mg twice daily or placebo and were followed for a median of 15 months ( with a 3-month blanking period ) .


QOL was assessed with a general-purpose health-related QOL tool ( 26-item World Health Organization QOL questionnaire ) at baseline and after 3 and 12 months .


Two hundred twenty-three randomized patients underwent ablation , and 206 patients were available for analysis ( 144 male , age 62.2 5.8 years ) .


AF recurrence rate in the colchicine group was 31.1 % ( 32/103 ) vs 49.5 % ( 51/103 ) in the control group ( P = .010 ) , translated in a relative risk reduction of 37 % ( odds ratio 0.46 , 95 % confidence interval 0.26-0 .81 ) .


The number needed to treat was 6 ( 95 % confidence interval 3.2-19 .8 ) .


Physical domain QOL scores at 12 months were 63.6 13.8 in the colchicine group and 52.5 18.1 in controls , whereas psychological domain scores were 56.1 13.7 vs 44.7 17.3 , respectively ( P < .001 , for both ) .


Colchicine treatment after pulmonary vein isolation for paroxysmal AF is associated with lower AF recurrence rates after a single procedure .


This reduction is accompanied by corresponding improvements in physical and psychological health-related QOL scores .


The aim of this study was to investigate whether effective suppression of central sleep apnea ( CSA ) by adaptive servo-ventilation ( ASV ) improves underlying cardiac dysfunction among patients with heart failure ( HF ) in whom CSA was not effectively suppressed by continuous positive airway pressure ( CPAP ) .


The presence of CSA in HF is associated with a poor prognosis , whereas CPAP treatment improves HF .


However , in a large-scale trial , CPAP failed to improve survival , probably due to insufficient CSA suppression .


Recently , ASV was reported as the most effective alternative to CSA suppression .


However , the effects of sufficient CSA suppression by ASV on cardiac function are unknown .


Patients with New York Heart Association classII HF , left ventricular ejection fraction < 50 % , and CSA that was unsuppressed ( defined as an apnea-hypopnea index15 ) despite3 months of CPAP were randomly assigned to receive ASV in either CPAP mode or ASV mode .


Of 23 patients enrolled , 12 were assigned to the ASV-mode group and 11 were assigned to the CPAP-mode group .


Three months after randomization , the ASV mode was significantly more effective in suppressing the apnea-hypopnea index ( from 25.0 6.9 events/h to 2.0 1.4 events/h ; p < 0.001 ) compared to the CPAP mode .


Compliance wassigni-ficantly greater with the ASV mode than with the CPAP mode .


Improvement in left ventricular ejection fraction was greater with the ASV mode ( 32.0 7.9 % to 37.8 9.1 % ; p < 0.001 ) than with the CPAPmode .


Patients with HF and unsuppressed CSA despite receiving CPAP may receive additional benefit by having CPAP replaced with ASV .


Additionally , effective suppression of CSA may improve cardiac function in HF patients .


The efficacy and safety of a single-dose of Montelukast sodium for treating virus-related infantile wheezing are investigated in this study .


A prospective , open , randomized , controlled study was carried out on 595 cases of infants who exhibited wheezing after a respiratory syncytial virus infection .


Treatment with Montelukast sodium was provided over the course of 12 weeks .


The clinical efficacy of Montelukast sodium was determined based on the clinical symptom score , tidal breathing lung function , and short-acting bronchodilator usage , as well as infantile asthma diagnosis rate change at the 4th and 12th week after the administration of the treatment .


The adverse reactions were also observed , and a control group was set .


The mean age of the 595 patients with infantile wheezing was 10.82 months 4.22 months .


Among these patients , 45.9 % ( 273 out of 595 ) had a family history of asthma , 30.6 % ( 182 out of 595 ) had allergic rhinitis , 23.9 % ( 142 out of 595 ) increased peripheral blood eosinophilia , 6.1 % ( 36 out of 595 ) exhibited total IgE increase , 40.0 % ( 238 out of 595 ) had a recurrent history of wheezing , and 64.0 % ( 381 out of 595 ) had a family history of eczema .


After 12 weeks of treatment , the clinical symptom scores significantly improved .


Significant differences in the cough , wheezing , and motility scores were observed before and after the treatment ( p < 0.05 ) .


TPTEF/TE and VPEF/VE significantly improved ( p < 0.05 ) after the treatment .


The asthma diagnosis rate was 9.6 % ( 57 out of 595 ) .


At four weeks after treatment , various indicators correspondingly improved .


Twenty-nine ( 4.9 % ) patients exhibited adverse reactions , 55.2 % exhibited excitation , 20.7 % suffered from insomnia , 10.3 % had headaches , 3.4 % had erythra , 3.4 % suffered from abdominal pain , and 3.4 % exhibited an increased glutamic-pyruvate transaminase level .


The symptoms of eczema were relieved to some extent , and the symptoms of rhinitis became less serious .


Significant differences were observed in the number of wheezing attacks , annual number of days hospitalized , annual number of days when 2AG was utilized , and lung function improvement ( p < 0.05 ) .


Montelukast sodium is clinically effective in treating virus-related wheezing , and clinical application for 4 weeks to 12 weeks can effectively relieve the symptoms of wheezing , improve lung function , and reduce the incidence rate of infantile asthma .


Montelukast sodium also causes few adverse reactions .


Simulators have been widely used to train operational skills in urology , how to improve its effectiveness deserves further investigation .


In this paper , we evaluated training using a novel transparent anatomic simulator , an opaque model or no simulator training , with regard to post-training ureteroscopy and cystoscopy proficiency .


Anatomically correct transparent and non-transparent endourological simulators were fabricated .


Ten experienced urologists provided a preliminary evaluation of the models as teaching tools .


36 first-year medical students underwent identical theoretical training and a 50-point examination of theoretical knowledge .


The students were randomly assigned to receive training with the transparent simulator ( Group 1 ) , the non-transparent simulator ( Group 2 ) or detailed verbal instruction only ( Group 3 ) .


12 days after the training session , the trainees ' skills at ureteral stent insertion and removal were evaluated using the Uro-Scopic Trainer and rated on an Objective Structured Assessment of Technical Skills ( OSATS ) scale .


The new simulators were successfully fabricated in accordance with the design parameters .


Of the ten urologists invited to evaluate the devices , 100 % rated the devices as anatomically accurate , 90 % thought both models were easy to use and 80 % thought they were good ureteroscopy and cystoscopy training tools .


The scores on the theoretical knowledge test were comparable among the training groups , and all students were able to perform ureteral stent insertion and removal .


The mean OSATS scores of groups 1 , 2 and 3 were 21.833.64 , 18.504.03 and 15.582.23 points , respectively , ( p = 0.001 ) .


Simulator training allowed students to achieve higher ureteroscopic and cystoscopic proficiency , and transparent simulators were more effective than non-transparent simulators .


To report a subgroup analysis comparing safety and effectiveness outcomes in Japanese and non-Japanese patients as part of a prospective , multinational , randomized controlled trial ( ClinicalTrials.gov identifier NCT00120406 ) evaluating a paclitaxel-coated drug-eluting stent ( DES ) compared to percutaneous transluminal angioplasty ( PTA ) for treating peripheral artery disease .


Patients were randomly assigned to primary DES or PTA .


In the Japanese cohort , 27 patients ( 21 men ; mean age 71.29.6 years ) were randomized to PTA and 25 patients ( 19 men ; mean age 69.810.2 years ) to primary DES .


In the non-Japanese cohort , 211 patients ( 131 men ; mean age 67.310.6 years ) were randomized to PTA and 211 patients ( 136 men ; mean age 67.69.5 years ) to primary DES .


Outcome measures included event-free survival ( EFS ) , freedom from target lesion revascularization ( TLR ) , patency , stent fracture , and sustained clinical benefit through 2 years .


Safety and effectiveness outcomes were similar in the Japanese and non-Japanese cohorts , although the outcomes in the Japanese cohort treated with primary DES were numerically better .


In the DES group , the 2-year EFS was 92.0 % vs. 85.0 % ( p = 0.61 ) , freedom from TLR was 96.0 % vs. 85.5 % ( p = 0.55 ) , primary patency was 80.0 % vs. 74.3 % ( p = 0.61 ) , and clinical benefit was sustained in 88.5 % vs. 80.5 % of patients ( p = 0.31 ) in the Japanese and non-Japanese cohorts , respectively .


Stent fractures were seen in 4 of 457 stents at 12 months : 3 in the Japanese cohort and 1 in the non-Japanese cohort .


The subgroup analysis comparing Japanese and non-Japanese patients supports the safety and effectiveness of the paclitaxel-coated DES in Japanese patients with stenotic lesions in the femoropopliteal arteries .


The lack of major differences associated with ethnicity in these 2-year outcomes supports the validity and value of multinational clinical trials .


To test the hypothesis that rapid eye movement ( REM ) sleep contributes to the consolidation of new memories , whereas non-rapid eye movement ( NREM ) sleep contributes to the prevention of retroactive interference .


Randomized , crossover study .


Two sessions of either a morning nap or wakefulness .


Twenty-five healthy young adults .


Declarative learning of word pairs followed by a nap or a wake interval , then learning of interfering word pairs and delayed recall of list A.


After a restricted night ( 24:00 -06:00 ) , participants learned a list of word pairs ( list A ) .


They were then required to either take a nap or stay awake during 45 min , after which they learned a second list of word pairs ( list B ) and then had to recall list A. Fifty percent of word pairs in list B shared the first word with list A , resulting in interference .


Ten subjects exhibited REM sleep whereas 13 subjects exhibited NREM stage 3 ( N3 ) sleep .


An interference effect was observed in the nap but not in the wake condition .


In post-learning naps , N3 sleep was associated with a reduced interference effect , which was not the case for REM sleep .


Moreover , participants exhibiting N3 sleep in the post-learning nap condition also showed a reduced interference effect in the wake condition , suggesting a higher protection ability against interference .


Our results partly support the hypothesis that non-rapid eye movement sleep contributes in protecting novel memories against interference .


However , rapid eye movement sleep-related consolidation is not evidenced .


To investigate effects of two doses of dexmedetomidine ( Dex ) on the recovery quality from general anesthesia undergoing thyroidectomy .


A prospective randomized controlled double-blind trial was conducted in 90 patients admitted to Shengjing Hospital of China Medical University who were scheduled for thyroidectomy .


They were randomly divided into three groups : group D0 .4 received Dex 0.4 g/kg intravenously , group D0 .8 received Dex 0.8 g/kg intravenously , and control group with same volume of normal saline .


There were 30 patients in each group , and all the patients received the above drug or saline 30 minutes after intubation .


The heart rate ( HR ) , systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) were recorded before Dex administration , at the end of surgery , time of eye opening and extubation , and 10 minutes after extubation .


Time of eye opening after surgery and time of extubation after eye opening were recorded .


End-tidal partial pressure of carbon dioxide ( PETCO2 ) before and after operation as well as restlessness score ( RS ) , Ramsay sedative score , and visual analogue pain scale ( VAS ) scores at 10 minutes after extubation were recorded .


Events during extubation including cough , nausea and vomiting , respiratory depression were also recorded .


( 1 ) Compared with control group , in D0 .4 and D0 .8 groups incidence of lowering of HR , SBP and DBP was lower at time of eye opening and extubation , and 10 minutes after extubation .


Compared with D0 .4 group , D0 .8 group had lower HR at the time of extubation and 10 minutes after extubation , SBP was lower at the time of eye opening and extubation , and lower DBP at the time of eye opening .


( 2 ) D0 .4 and D0 .8 groups showed lower RS and VAS scores than those of control group , Ramsay sedative score in groups D0 .4 and D0 .8 was higher than that in control group ( RS : 1.400.51 , 1.200.42 vs. 1.900.56 ; VAS : 1.500.52 , 0.800.63 vs. 2.500.52 ; Ramsay : 2.100.56 , 2.400.51 vs. 1.600.51 , P < 0.05 or P < 0.01 ) , and VAS score in group D0 .8 was lower than that in D0 .4 group ( P < 0.01 ) .


The time of eye opening and extubation were longer in group D0 .8 as compared with those in control and D0 .4 groups ( 12.501.08 minutes vs. 10.501.58 minutes , 10.401.26 minutes ; 15.000.94 minutes vs. 13.001.63 minutes , 12.801.13 minutes , P < 0.05 or P < 0.01 ) , but there was no significant difference between the latter two groups .


No significant difference in PETCO2 was found among three groups before and after surgery .


( 3 ) The incidence rate of cough , nausea and vomiting in control group ( 16.7 % , 13.3 % ) were significantly higher than those in groups D0 .4 ( 3.3 % , 0 ) and D0 .8 ( 0 , 0 ) .


There was no respiratory depression in the three groups .


Adjunctive infusion of Dex 0.4 g/kg at 30 minutes after anesthesia induction was recommended as it may result in more steady hemodynamics , with shorter recovery time and extubation time after thyroidectomy .


To investigate the efficacy of pretreatment with cisatracurium for prevention of pain associated with propofol injection , and compare its efficacy with that of lidocaine .


Patients undergoing general anaesthesia were randomized to receive normal saline ( control group ) , lidocaine ( 0.5 mg/kg ) , 0.03 mg/kg cisatracurium or 0.15 mg/kg cisatracurium .


All drugs were administered into the largest dorsal vein of the hand with venous occlusion for 30 s , followed by propofol ( 0.5 mg/kg ) .


Pain was evaluated using a four-point scale .


The incidence and severity of pain was significantly lower in the lidocaine and 0.15 mg/kg cisatracurium groups than the control and 0.03 mg/kg cisatracurium groups ( n = 50/group ) .


There was no significant difference between the lidocaine and 0.15 mg/kg cisatracurium groups in the incidence and severity of pain .


0.15 mg/kg cisatracurium effectively decreases the incidence and severity of pain induced by propofol injection without any significant complications .


The vascular effects of acute calcitonin gene-related peptide ( CGRP ) inhibition are well described , but the effects of sustained inhibition warrant further exploration in humans .


The objective of this article is to assess the effects of sustained CGRP inhibition on blood pressure , heart rate , and ECGs in healthy women 40 years of age .


In this double-blind , placebo-controlled study , 31 women ( mean age = 56 ) were randomized to receive placebo or an anti-CGRP monoclonal antibody at doses up to 2000 mg .


Participants were confined for seven days and followed for 168 days .


Cardiac telemetry was conducted for eight hours after infusion completion .


Hemodynamic assessments and ECGs were conducted six times during Day 1 and periodically for three months .


No clinically relevant changes in systolic or diastolic blood pressure , heart rate , or ECG parameters ( RR , PR , QRS , or QTcF ) were observed when comparing baseline vs. post-dose time-points or in-between groups .


No significant changes were seen for adjusted QTcF ( baseline subtracted and placebo and baseline subtracted ) .


No significant differences or relevant abnormalities were seen when comparing parameters obtained at Tmax vs. any other time-point .


Sustained CGRP inhibition was not associated with hemodynamic or ECG changes in a population at an increased age risk for cardiovascular events .


Given the importance of influence networks in the implementation of evidence-based practices and interventions , it is unclear whether such networks continue to operate as sources of information and advice when they are segmented and disrupted by randomization to different implementation strategy conditions .


The present study examines the linkages across implementation strategy conditions of social influence networks of leaders of youth-serving systems in 12 California counties participating in a randomized controlled trial of community development teams ( CDTs ) to scale up use of an evidence-based practice .


Semi-structured interviews were conducted with 38 directors , assistant directors , and program managers of county probation , mental health , and child welfare departments .


A web-based survey collected additional quantitative data on information and advice networks of study participants .


A mixed-methods approach to data analysis was used to create a sociometric data set ( n = 176 ) to examine linkages between treatment and standard conditions .


Of those network members who were affiliated with a county ( n = 137 ) , only 6 ( 4.4 % ) were directly connected to a member of the opposite implementation strategy condition ; 19 ( 13.9 % ) were connected by two steps or fewer to a member of the opposite implementation strategy condition ; 64 ( 46.7 % ) were connected by three or fewer steps to a member of the opposite implementation strategy condition .


Most of the indirect steps between individuals who were in different implementation strategy conditions were connections involving a third non-county organizational entity that had an important role in the trial in keeping the implementation strategy conditions separate .


When these entities were excluded , the CDT network exhibited fewer components and significantly higher betweenness centralization than did the standard condition network .


Although the integrity of the RCT in this instance was not compromised by study participant influence networks , RCT designs should consider how influence networks may extend beyond boundaries established by the randomization process in implementation studies .


NCT00880126 .


Type 2 diabetes is a major risk factor for chronic kidney disease , which substantially increases the risk of cardiovascular disease mortality .


This Phase IIb safety study ( AleNephro ) in patients with stage 3 chronic kidney disease and type 2 diabetes , evaluated the renal effects of aleglitazar , a balanced peroxisome proliferator-activated receptor - / agonist .


Patients were randomized to 52 weeks ' double-blind treatment with aleglitazar 150 g/day ( n = 150 ) or pioglitazone 45 mg/day ( n = 152 ) , followed by an 8-week off-treatment period .


The primary endpoint was non-inferiority for the difference between aleglitazar and pioglitazone in percentage change in estimated glomerular filtration rate from baseline to end of follow-up .


Secondary endpoints included change from baseline in estimated glomerular filtration rate and lipid profiles at end of treatment .


Mean estimated glomerular filtration rate change from baseline to end of follow-up was -2.7 % ( 95 % confidence interval : -7.7 , 2.4 ) with aleglitazar versus -3.4 % ( 95 % confidence interval : -8.5 , 1.7 ) with pioglitazone , establishing non-inferiority ( 0.77 % ; 95 % confidence interval : -4.5 , 6.0 ) .


Aleglitazar was associated with a 15 % decrease in estimated glomerular filtration rate versus 5.4 % with pioglitazone at end of treatment , which plateaued to 8 weeks and was not progressive .


Superior improvements in high-density lipoprotein cholesterol , low-density lipoprotein cholesterol and triglycerides , with similar effects on glycosylated hemoglobin were observed with aleglitazar versus pioglitazone .


No major safety concerns were identified .


The primary endpoint in AleNephro was met , indicating that in stage 3 chronic kidney disease patients with type 2 diabetes , the decrease in estimated glomerular filtration rate after 52 weeks ' treatment with aleglitazar followed by 8 weeks off-treatment was reversible and comparable ( non-inferior ) to pioglitazone .


NCT01043029 January 5 , 2010 .


An increase in the potency of the cannabis cigarettes has been observed over the past three decades .


In this study , we aimed to establish the impact of 9-tetrahydrocannabinol ( THC ) on the rating of subjective effects ( intensity and duration of the effects ) , up to 23 % THC potency ( 69 mg THC ) among recreational users .


Recreational users ( N = 24 ) smoked cannabis cigarettes with four doses of THC ( placebo 29 , 49 and 69 mg of THC ) on four separate test days in a randomized , double-blind , placebo-controlled , crossover study .


The participants filled in three different questionnaires measuring subjective effects during the exposure up to 8 h post-smoking .


The ` high ' feeling , heart rate , blood pressure and THC serum concentrations were also regularly recorded during these 8 h.


THC significantly increased the high feeling , dizziness , dry-mouthed feeling , palpitations , impaired memory and concentration , and ` down ' , ` sedated ' and ` anxious ' feelings .


In addition , THC significantly decreased alertness , contentment and calmness .


A cubic relationship was observed between ` feeling the drug ' and ` wanting more ' .


The THC-induced decrease in ` feeling stimulated ' and increase in anxiety lasted up to 8 h post-smoking .


Sedation at 8 h post-smoking was increased by a factor of 5.7 with the highest THC dose , compared to the placebo .


This study shows a strong effect of cannabis containing high percentages of THC on the rating of subjective effects .


Regular users and forensic toxicologists should be aware that the THC-induced increase in ` feeling sedated ' continues longer with a 69 mg THC dose than with a 29 mg THC dose .


Increased levels of oxidative stress have been seen in animal models of dry eye and in the conjunctival epithelial cells of patients with Sjgren 's syndrome .


The aims of this study were to compare the levels of oxidative stress in patients with dry eye and patients without dry eye and to evaluate the effects of treatment with preservative-free eye drops containing hyaluronic acid 0.15 % and vitamin B12 on oxidative stress and dry eye symptoms .


Three cohorts of patients who were to undergo planned cataract surgery were enrolled : patients with dry eye randomized to either no treatment ( n = 29 ) or treatment ( n = 32 ) with hyaluronic acid/vitamin B12 eye drops , and patients without dry eye ( n = 42 ) .


Patients were assessed by Schirmer 's type I test , fluorescein clearance test ( FCT ) , Break Up Time ( BUT ) , and Ocular Surface Disease Index ( OSDI ) .


Lipid peroxidation , a marker of oxidative stress , was assessed by LP-CHOLOX test .


Compared with patients without dry eye , patients with dry eye had significantly increased levels of oxidative stress , higher OSDI and FCT scores , and significantly lower Schirmer 's test and BUT scores .


Treatment with eye drops containing hyaluronic acid 0.15 % and vitamin B12 was associated with significantly reduced levels of oxidative stress and OSDI and FCT scores and significantly increased Schirmer 's test and BUT scores .


These findings indicate that oxidative stress is associated with dry eye and that hyaluronic acid/vitamin B12 eye drops may attenuate oxidative stress and inflammation , improving dry eye symptoms .


Further study in controlled clinical trials is warranted .


A recent randomized controlled trial provided preliminary evidence for the effectiveness of mindfulness based cognitive therapy ( MBCT ) for the top 10 % frequent attenders in primary care with persistent medically unexplained symptoms ( MUS ) .


This qualitative study aims to explore working mechanisms and possible barriers of MBCT in this population .


Twelve participants of the trial were interviewed about their experiences .


This was done before and after the MBCT course , and 12 months later .


Written evaluations of participants and notes of participant observers were used for data-triangulation .


In total , 35 qualitative interviews were conducted .


MBCT initiated a process of change , starting with awareness of the present moment , the associated sensory experiences , thoughts and emotions and accepting rather than resisting these .


Participants started to recognize their own behavioral patterns and change them , thus improving self-care .


Self-compassion seemed to result from and facilitate this process .


Main barriers were concurrent social problems and the inability or unwillingness to accept symptoms .


MBCT can start a process of change in patients with persistent MUS .


Awareness and acceptance of painful symptoms and emotions are key factors in this process .


Change of unhelpful behavioral patterns and increased self-care and self-compassion can result from this process .


Treatment-emergent symptoms with adjuvant tamoxifen and aromatase inhibitors ( AIs ) have been associated with superior recurrence-free survival ( RFS ) .


We hypothesized that MA .27 anastrozole - or exemestane-treated patients with new or worsening vasomotor and/or joint symptoms would have improved RFS .


MA .27 randomly assigned 7,576 postmenopausal women with breast cancer to 5 years of anastrozole or exemestane .


Patient-reported symptoms were collected using the Common Terminology Criteria for Adverse Events version 3.0 at protocol-specified baseline and 6 - and 12-month clinical visits .


Symptoms were considered present with either vasomotor and/or joint complaints .


Associations between symptoms and baseline patient characteristics were examined with ( 2 ) and Fisher 's exact tests .


Subsequent effects of new or worsening symptoms on RFS were examined with landmark analyses and stratified univariable and multivariable Cox models .


We examined the effects of 3-month symptoms arising from unplanned clinic visits as a result of severe toxicity .


Patients were assessable if eligible for the MA .27 trial , received some trial therapy , and had no disease recurrence at the end of a symptom assessment period ; 96 % of patients ( n = 7,306 patients ) were included at 6 months , and 96 % ( n = 7,246 ) were included at 12 months .


Thirty-four percent of patients had baseline symptoms .


For patients without baseline symptoms , 25 % and 52 % had new symptoms by 6 and 12 months , respectively .


Neither treatment-emergent nor baseline symptoms significantly impacted RFS ( P > .10 ) in patients with or without baseline symptoms .


In MA .27 , anastrozole or exemestane treatment-emergent symptoms were not associated with improved RFS .


Women should be supported through treatment and encouraged to remain on their AI regardless of their symptoms .


Whether noninvasive ventilation should be administered in patients with acute hypoxemic respiratory failure is debated .


Therapy with high-flow oxygen through a nasal cannula may offer an alternative in patients with hypoxemia .


We performed a multicenter , open-label trial in which we randomly assigned patients without hypercapnia who had acute hypoxemic respiratory failure and a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of 300 mm Hg or less to high-flow oxygen therapy , standard oxygen therapy delivered through a face mask , or noninvasive positive-pressure ventilation .


The primary outcome was the proportion of patients intubated at day 28 ; secondary outcomes included all-cause mortality in the intensive care unit and at 90 days and the number of ventilator-free days at day 28 .


A total of 310 patients were included in the analyses .


The intubation rate ( primary outcome ) was 38 % ( 40 of 106 patients ) in the high-flow-oxygen group , 47 % ( 44 of 94 ) in the standard group , and 50 % ( 55 of 110 ) in the noninvasive-ventilation group ( P = 0.18 for all comparisons ) .


The number of ventilator-free days at day 28 was significantly higher in the high-flow-oxygen group ( 248 days , vs. 2210 in the standard-oxygen group and 1912 in the noninvasive-ventilation group ; P = 0.02 for all comparisons ) .


The hazard ratio for death at 90 days was 2.01 ( 95 % confidence interval [ CI ] , 1.01 to 3.99 ) with standard oxygen versus high-flow oxygen ( P = 0.046 ) and 2.50 ( 95 % CI , 1.31 to 4.78 ) with noninvasive ventilation versus high-flow oxygen ( P = 0.006 ) .


In patients with nonhypercapnic acute hypoxemic respiratory failure , treatment with high-flow oxygen , standard oxygen , or noninvasive ventilation did not result in significantly different intubation rates .


There was a significant difference in favor of high-flow oxygen in 90-day mortality .


( Funded by the Programme Hospitalier de Recherche Clinique Interrgional 2010 of the French Ministry of Health ; FLORALI ClinicalTrials.gov number , NCT01320384 . )


The purpose of the study was to determine the cariostatic potential of a chewing gum containing tea polyphenol .


A total of 157 schoolchildren aged 8-9 years were randomly allocated into three groups .


Two groups received chewing gum with or without tea polyphenol .


A third group did not receive any chewing gum .


A single examiner assessed the caries status for all participates at baseline , 12 months and 24 months .


A one-way analysis of variance ( ANOVA ) was performed to evaluate differences among the groups at each interval The Chi-square test was used to compare the caries-free rate among the three groups .


The mean DMFT increment was 0.17 for the polyphenol gum group , 0.60 for the control gum group , and 1.15 for the no gum group .


Children who chewed gum containing tea polyphenol had a significantly lower mean DMFS increment over the 24-month period than did the other two groups ( p < 0.05 ) .


The caries-free rate in the polyphenol gum group was significantly higher than that in the other two groups ( p < 0.05 ) after two years .


These findings indicated that the oral application of chewing gum with tea polyphenol has an inhibitory effect on dental caries .


The aim of this clinical trial was to determine the clinical and biochemical efficacy of an 810 nm diode laser as an adjunct to scaling and root planing ( SRP ) .


Lasers can achieve excellent tissue ablation with strong bactericidal and detoxification effects .


The use of lasers is one of the most promising new technical modalities for nonsurgical periodontal treatment .


However , the most effective wavelength and parameters for their use are still under investigation .


This study was designed as a single-blinded , randomized-controlled , split-mouth clinical trial .


Twenty-one patients ( 12 females and 9 males between 26 and 55 years of age ) , diagnosed with generalized chronic periodontitis , were included in the study .


After initial periodontal therapy , which consisted of oral hygiene instructions and scaling , patients underwent two different treatment modalities .


Test and control sites were chosen with coin toss randomization .


At the test site , patients received SRP and laser treatment ; at the contralateral control site , they received SRP treatment alone .


Both treatment modalities resulted in significant improvements in all clinical and biochemical parameters .


Sites irradiated with an 810 nm diode laser using the `` hot tip '' ( 760 C ) technique showed enhanced healing in all the registered periodontal variables and interleukin ( IL ) -1 levels , compared with SRP alone .


Within the limitations of this study , the use of diode lasers as an adjunct to SRP produced significant improvements in clinical parameters as well as gingival crevicular fluid ( GCF ) IL-1 levels in the 6 month study period .


To examine day care treatment of nausea and vomiting of pregnancy compared with the traditional inpatient management of this condition .


We conducted an open-label , single-center , randomized controlled trial to examine the differences between day care and inpatient management of pregnant women with nausea and vomiting of pregnancy .


Primary outcome was total number of inpatient nights related to nausea and vomiting of pregnancy .


Ninety-eight women were randomized to initial day care management ( n = 42 ) or inpatient management ( n = 56 ) .


Results are calculated from the time of randomization until resolution of nausea and vomiting of pregnancy .


Women randomized to inpatient care experienced a median ( interquartile range ) of 2 ( 1-4 ) inpatient days compared with 0 ( 0-2 ) inpatient days for women randomized to day care ( P < .001 ) .


Women randomized to initial treatment as an inpatient had significantly more median total number of inpatient admissions ( one [ 1-2 ] compared with zero [ 0-1 ] admissions ; P < .001 ) compared with women randomized to day care .


No significant differences were observed in day care visits ( median [ interquartile range ] one [ 1-4 ] compared with two [ 1-4 ] ; P = .30 ) .


Women randomized to inpatient care were as satisfied with their care as those randomized to day care ( median [ interquartile range ] : 67 [ 57-69 ] compared with 63 [ 58-71 ] Client Satisfaction Questionnaire score ; P = .7 ) .


Day care treatment of nausea and vomiting of pregnancy reduced hospital inpatient stay and was acceptable to patients .


ISRCTN Register , http://www.isrctn.org , ISRCTN05023126 .


: I.


Pain during bone marrow biopsy ( BMB ) under local anaesthesia ( LA ) is reported in 70 % of patients , of whom 35 % rate the pain as severe .


Pain is experienced during both the biopsy and the marrow aspiration .


Many medical centres use conscious sedation involving benzodiazepines and/or opioids administered orally or intravenously for BMB analgesia .


Methoxyflurane ( MEOF ) is self-administered by a handheld device ( the Penthrox inhaler ) , which is licensed in Australia for the relief of pain associated with short surgical procedures .


To evaluate the efficacy and safety of MEOF analgesia in patients with cancer undergoing BMB .


Patients received LA plus either MEOF or placebo .


The primary endpoint was worst pain intensity measured with the Numerical Rating Scale .


Anxiety was assessed with the State Trait Anxiety Inventory ( STAI-Y-1 ) .


Patients , operators and the research nurse rated global medication performance using a 5-point Likert scale .


Forty-nine of the 50 patients randomised to MEOF and 48 of the 50 patients randomised to placebo effectively received the allocated intervention .


MeanSD worst pain overall was 4.902.07 in MEOF group and 6.02.24 in placebo group ( p = 0.011 ) .


Worst pain during the aspiration was 3.32.0 in MEOF group and 5.02.4 in placebo group ( p < 0.001 ) .


49 % of patients treated with MEOF rated the medication as very good or excellent compared with 16.5 % of the patients treated with placebo ( p = 0.005 ) .


20.4 % of patients treated with MEOF had an adverse event ( AE ) compared with 4.2 % in the placebo arm ( p = 0.028 ) .


All AEs were grade 1 .


MEOF was safe and performed better than placebo for analgesia in BMB procedures .


Individuals with serious mental illness ( SMI ) are dying on average 25 years prematurely .


The leading causes are chronic preventable diseases .


In the context of a tobacco-treatment trial , this exploratory study examined the behavioral risk profiles of adults with SMI to identify broader interventional needs .


Recruited from five acute inpatient psychiatry units , participants were 693 adult smokers ( recruitment rate = 76 % , 50 % male , 45 % Caucasian , age M = 39 , 49 % had income < $ 10,000 ) diagnosed with mood disorders ( 71 % ) , substance-use disorders ( 63 % ) , posttraumatic stress disorder ( 39 % ) , psychotic disorders ( 25 % ) , and attention deficit-hyperactivity disorder ( 25 % ) .


The Staging Health Risk Assessment , the primary measure used in this study , screened for risk status and readiness to change 11 health behaviors , referencing the period prior to acute hospitalization .


Participants averaged 5.2 ( SD = 2.1 ) risk behaviors , including smoking ( 100 % ) , high-fat diet ( 68 % ) , inadequate fruits/vegetables ( 67 % ) , poor sleep ( 53 % ) , physical inactivity ( 52 % ) , and marijuana use ( 46 % ) .


The percent prepared to change ranged from 23 % for tobacco and marijuana to 76 % for depression management .


Latent class analysis differentiated three risk groups : the global higher risk group included patients elevated on all risk behaviors ; the global lower risk group was low on all risks ; and a mood and metabolic risk group , characterized by inactivity , unhealthy diet , sleep problems , and poor stress and depression management .


The global higher risk group ( 11 % of sample ) was younger , largely male , and had the greatest number of risk behaviors and mental health diagnoses ; had the most severe psychopathologies , addiction-treatment histories , and nicotine dependence ; and the lowest confidence for quitting smoking and commitment to abstinence .


Most smokers with SMI engaged in multiple risks .


Expanding targets to treat co-occurring risks and personalizing treatment to individuals ' multibehavioral profiles may increase intervention relevance , interest , and impact on health .


Airway hyperresponsiveness ( AHR ) to indirect agents like mannitol is thought to be dependent on concurrent airway inflammation as these stimuli exert their effects via the release of bronchoconstricting mediators from inflammatory cells .


Airway inflammation correlates negatively with deep inhalation bronchoprotection against direct stimuli like methacholine .


We hypothesised that deep inhalation bronchoprotection to methacholine would be absent and airway inflammation would be present in individuals with AHR to inhaled mannitol .


Twenty asthmatic , otherwise healthy individuals , either gender , aged 18-65 years , with a Visit 1 ( screening ) methacholine two-minute tidal breathing PC20 of 16 mg/mL or less completed the study .


Visits 2 and 3 consisted of either mannitol or deep inhalation methacholine challenge in random order , at least 24 h apart .


All visits were completed within a period of two weeks .


Eleven of the twenty participants had AHR to mannitol ( PD15 635 mg , the `` responders '' ) and nine did not ( the `` non-responders '' ) .


Responders did not bronchoprotect to methacholine via deep inhalation ( doubling dose shift = 0.7 ; p = 0.13 ) and had high levels of exhaled nitric oxide ( geometric mean 49 ppb ; range 16-109 ppb ) .


Conversely , significant deep inhalation bronchoprotection to methacholine occurred in the non-responder group ( doubling dose shift = 1.6 ; p = 0.013 ) .


This group also had significantly lower levels of exhaled nitric oxide ( geometric mean 23 ppb ( range 16-45 ppb ; p = 0.015 ) .


Deep inhalation bronchoprotection to methacholine and low levels of exhaled nitric oxide coincide with mannitol non-responsiveness in an asthmatic population .


Clinical Trials Registration #NCT 01642745 ( clinicaltrials.gov ) .


Combat post-traumatic stress disorder ( PTSD ) involves significant suffering , impairments in social and occupational functioning , substance use and medical comorbidity , and increased mortality from suicide and other causes .


Many veterans continue to suffer despite current treatments .


Deep brain stimulation ( DBS ) has shown promise in refractory movement disorders , depression and obsessive-compulsive disorder , with deep brain targets chosen by integration of clinical and neuroimaging literature .


The basolateral amygdala ( BLn ) is an optimal target for high-frequency DBS in PTSD based on neurocircuitry findings from a variety of perspectives .


DBS of the BLn was validated in a rat model of PTSD by our group , and limited data from humans support the potential safety and effectiveness of BLn DBS .


We describe the protocol design for a first-ever Phase I pilot study of bilateral BLn high-frequency DBS for six severely ill , functionally impaired combat veterans with PTSD refractory to conventional treatments .


After implantation , patients are monitored for a month with stimulators off .


An electroencephalographic ( EEG ) telemetry session will test safety of stimulation before randomization to staggered-onset , double-blind sham versus active stimulation for two months .


Thereafter , patients will undergo an open-label stimulation for a total of 24 months .


Primary efficacy outcome is a 30 % decrease in the Clinician Administered PTSD Scale ( CAPS ) total score .


Safety outcomes include extensive assessments of psychiatric and neurologic symptoms , psychosocial function , amygdala-specific and general neuropsychological functions , and EEG changes .


The protocol requires the veteran to have a cohabiting significant other who is willing to assist in monitoring safety and effect on social functioning .


At baseline and after approximately one year of stimulation , trauma script-provoked 18FDG PET metabolic changes in limbic circuitry will also be evaluated .


While the rationale for studying DBS for PTSD is ethically and scientifically justified , the importance of the amygdaloid complex and its connections for a myriad of emotional , perceptual , behavioral , and vegetative functions requires a complex trial design in terms of outcome measures .


Knowledge generated from this pilot trial can be used to design future studies to determine the potential of DBS to benefit both veterans and nonveterans suffering from treatment-refractory PTSD .


PCC121657 , 19 March 2014 .


While propranolol is touted as superior to prednisolone for treating infantile hemangiomas ( IH ) , a randomized clinical trial ( RCT ) comparing the outcome and tolerability of these medications for symptomatic , proliferating IH has not been reported .


To determine if oral propranolol is more efficacious and better tolerated than prednisolone in treating symptomatic , proliferating IH and to determine the feasibility of conducting a multi-institutional , RCT comparing efficacy and tolerability of both medications .


Phase 2 , investigator-blinded , multi-institutional RCT conducted in 3 academic vascular anomalies clinics on 19 of 44 eligible infants aged between 2 weeks and 6 months .


All participating patients had symptomatic proliferating IH treated between September 1 , 2010 , and August 1 , 2012 .


Treatment with oral propranolol vs prednisolone ( 2.0 mg/kg/d ) until halted owing to toxic effects or clinical response .


Primary outcome was change in IH size after 4 months of therapy .


Secondary outcomes were response rate and frequency and severity of adverse events ( AEs ) .


The primary outcome showed no difference in lesion size or affected skin area after 4 months of therapy : 41 % and 1.32 mm2 for prednisolone vs 64 % and 0.55 mm2 for propranolol ( P = .12 for lesion size , and P = .56 for affected skin area ) .


Longitudinal analyses showed a faster response in total lesion outer dimension with prednisolone ( P = .03 ) , but this advantage over time was not noted when central clearing and outer dimension were included in the analysis ( P = .91 ) .


The overall frequency of AEs was similar ( 44 for prednisolone vs 32 for propranolol ) ( P = .84 ) , but prednisolone-treated participants had more grade 3 severe AEs ( 11 vs 1 ) ( P = .01 ) , particularly growth retardation resulting in size and weight below the fifth percentile .


Early study withdrawal owing to AEs occurred in 6 ( 75 % ) of 8 patients in the prednisolone group but 0 of 11 propranolol-treated participants .


The mean duration of therapy was shorter for prednisolone ( 141 vs 265 days ) , reflecting the higher rate of early withdrawals .


Both medications show similar efficacy for reducing the area of symptomatic , proliferating IH .


Although prednisolone showed a faster response rate , propranolol was better tolerated with significantly fewer severe AEs .


Propranolol should be the first line of therapy for symptomatic IH unless contraindicated or unless future studies demonstrate severe AEs from propranolol .


Recruiting participants for a phase 3 RCT would be difficult owing to safety profiles measured here and emerging trends favoring propranolol .


TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00967226 .


Mammographic breast density is one of the strongest independent risk factors for developing breast cancer .


We examined the effect of exemestane and tamoxifen on breast density in Dutch postmenopausal early breast cancer patients participating in the Tamoxifen Exemestane Adjuvant Multinational ( TEAM ) trial .


Analogue mammograms of selected TEAM participants before start , and after one and two ( and if available after three ) years of adjuvant endocrine therapy were collected centrally and reviewed .


Study endpoints were change in breast density over time , and correlations between breast density and locoregional recurrence ( LRR ) , distance recurrence ( DR ) , and contralateral breast cancer ( CBC ) .


Mammograms of 378 patients ( 181 tamoxifen , 197 exemestane ) were included in the current per protocol analyses .


Baseline breast density was low ( breast density score < 50 % in 75 % of patients ) and not different between patients randomised to exemestane or tamoxifen ( coefficient 0.16 , standard error 0.17 ) .


Breast density did not change during treatment in exemestane ( p = 0.25 ) or tamoxifen users ( p = 0.59 ) .


No relation was observed between breast density and the occurrence of a LRR [ hazards ratio ( HR ) 0.87 , 95 % CI 0.45-1 .68 , p = 0.67 ] , a DR ( HR 1.02 , 95 % CI 0.77-1 .35 , p = 0.90 ) , or CBC ( HR 1.31 , 95 % CI 0.63-2 .72 , p = 0.48 ) .


The in general low breast density score in early postmenopausal breast cancer patients did not substantially change over time , and this pattern was not different between tamoxifen and exemestane users .


Breast density was not a predictive marker for efficacy of adjuvant endocrine therapy .


The control arm of PATRICIA ( PApilloma TRIal against Cancer In young Adults , NCT00122681 ) was used to investigate the risk of progression from cervical HPV infection to cervical intraepithelial neoplasia ( CIN ) or clearance of infection , and associated determinants .


Women aged 15-25 years were enrolled .


A 6-month persistent HPV infection ( 6MPI ) was defined as detection of the same HPV type at two consecutive evaluations over 6 months and clearance as 2 type-specific HPV negative samples taken at two consecutive intervals of approximately 6 months following a positive sample .


The primary endpoint was CIN grade 2 or greater ( CIN2 + ) associated with the same HPV type as a 6MPI .


Secondary endpoints were CIN1 + / CIN3 + associated with the same HPV type as a 6MPI ; CIN1 + / CIN2 + / CIN3 + associated with an infection of any duration ; and clearance of infection .


The analyses included 4825 women with 16,785 infections ( 3363 women with 6902 6MPIs ) .


Risk of developing a CIN1 + / CIN2 + / CIN3 + associated with same HPV type as a 6MPI varied with HPV type and was significantly higher for oncogenic versus non-oncogenic types .


Hazard ratios for development of CIN2 + were 10.44 ( 95 % CI : 6.96-15 .65 ) , 9.65 ( 5.97-15 .60 ) , 5.68 ( 3.50-9 .21 ) , 5.38 ( 2.87-10 .06 ) and 3.87 ( 2.38-6 .30 ) for HPV-16 , HPV-33 , HPV-31 , HPV-45 and HPV-18 , respectively .


HPV-16 or HPV-33 6MPIs had ~ 25-fold higher risk for progression to CIN3 + .


Previous or concomitant HPV infection or CIN1 + associated with a different HPV type increased risk .


Of the different oncogenic HPV types , HPV-16 and HPV-31 infections were least likely to clear .


Cervical infections with oncogenic HPV types increased the risk of CIN2 + and CIN3 + .


Previous or concomitant infection or CIN1 + also increased the risk .


HPV-16 and HPV-33 have by far the highest risk of progression to CIN3 + , and HPV-16 and HPV-31 have the lowest chance of clearance .


Studies of closed-loop control ( CLC ) systems have improved glucose levels in patients with type 1 diabetes .


In this study we test a new CLC concept aiming to `` reset '' the patient overnight to near-normoglycemia each morning , for several consecutive nights .


Ten insulin pump users with type 1 diabetes ( mean age , 46.48.5 years ) were enrolled in a two-center ( in the United States and Italy ) randomized crossover trial comparing 5 consecutive nights of CLC ( 23:00 -07:00 h ) in an outpatient setting versus sensor-augmented insulin pump therapy of the same duration at home .


Primary end points included time spent in 80-140mg / dL as measured by continuous glucose monitoring overnight and fasting blood glucose distribution at 7:00 h.


Compared with sensor-augmented pump therapy , CLC improved significantly time spent between 80 and 140mg/dL ( 54.5 % vs. 32.2 % ; P < 0.001 ) and between 70 and 180mg/dL ( 85.4 % vs. 59.1 % ; P < 0.001 ) ; CLC reduced the mean glucose level at 07:00 h ( 119.3 vs. 152.9 mg/dL ; P < 0.001 ) and overnight mean glucose level ( 139.0 vs. 170.3 mg/dL ; P < 0.001 ) using a marginally lower amount of insulin ( 6.1 vs. 6.8 units ; P = 0.1 ) .


Tighter overnight control led to improved daytime control on the next day : the overnight/next-day control correlation was r = 0.52 , P < 0.01 .


Multinight CLC of insulin delivery ( artificial pancreas ) results in significant improvement in morning and overnight glucose levels and time in target range , with the potential to improve daytime control when glucose levels were `` reset '' to near-normoglycemia each morning .


To describe a new framework for interleaving scans and demonstrate its usefulness for image-based respiratory motion correction in whole heart coronary MR angiography ( CMRA ) .


Scan interleaving using the proposed approach was achieved by switching between separately defined , independent scans at arbitrary time points during their execution , using a generic function call .


The scan interleaving framework was used to perform scan interleaving for image-based respiratory navigation of CMRA with spiral , radial , and Cartesian echo-planar imaging ( EPI ) navigator k-space trajectories .


Eight healthy volunteers were scanned .


Improved coronary vessel sharpness and visual scores were obtained using spiral and Cartesian EPI navigators compared with radial navigators .


The usefulness of the proposed scan interleaving framework was demonstrated for image-based respiratory motion correction .


It facilitated more direct comparisons of image navigator acquisitions with different k-space trajectories .


Furthermore , we could demonstrate that spiral and Cartesian EPI navigators may be particularly suitable for image-based motion correction , as they provide improved motion correction and high navigator apparent signal-to-noise ratio while spending very little magnetization , thereby minimizing saturation effects .


The redox imbalance between nitric oxide and superoxide generated in the endothelium is thought to play a pivotal role in the development of endothelial dysfunction .


A third reactive oxygen species ( ROS ) , H2O2 , is known to have both beneficial and detrimental effects on the vasculature .


Nonetheless , the influence of the hydroxyl radical , a byproduct of H2O2 decay , is unclear , and there is no direct evidence that the hydroxyl radical impairs endothelial function in conduit arteries .


Molecular hydrogen ( H2 ) neutralizes detrimental ROS , especially the hydroxyl radical .


To assess the influence of the hydroxyl radical on the endothelium and to confirm that a gaseous antioxidant , H2 , can be a useful modulator of blood vessel function .


The efficacy of water containing a high concentration of H2 was tested by measuring flow-mediated dilation ( FMD ) of the brachial artery ( BA ) .


The subjects were randomly divided into two groups : the high-H2 group , who drank high-H2 water containing 7 ppm H2 ( 3.5 mg H2 in 500 mL water ) ; and the placebo group .


Endothelial function was evaluated by measuring the FMD of the BA .


After measurement of diameter of the BA and FMD at baseline , volunteers drank the high-H2 water or placebo water immediately and with a 30-minute interval ; FMD was compared to baseline .


FMD increased in the high-H2 group ( eight males ; eight females ) from 6.80 % 1.96 % to 7.64 % 1.68 % ( mean standard deviation ) and decreased from 8.07 % 2.41 % to 6.87 % 2.94 % in the placebo group ( ten males ; eight females ) .


The ratio to the baseline in the changes of FMD showed significant improvement ( P < 0.05 ) in the high-H2 group compared to the placebo group .


H2 may protect the vasculature from shear stress-derived detrimental ROS , such as the hydroxyl radical , by maintaining the nitric oxide-mediated vasomotor response .


To evaluate whether hysteroscopic morcellation or bipolar electrosurgical resection is more favorable for removing endometrial polyps in an office setting in terms of feasibility , speed , pain , and acceptability .


A multicenter , single-blind , randomized , controlled trial of office hysteroscopic morcellation compared with electrosurgical resection was conducted .


A total of 121 women were randomly allocated to polyp removal by one of the two methods in an office setting .


The outcomes assessed were time taken to complete the endometrial polypectomy , defined as the time from insertion to removal of vaginal instrumentation , completeness of polyp removal , acceptability , and pain measured on a 100-mm visual analog scale .


The median time taken to complete the procedure was 5 minutes and 28 seconds for morcellation compared with 10 minutes and 12 seconds for electrosurgical resection ( P < .001 ) .


The polyps were completely removed in 61 out of 62 ( 98 % ) women assigned to morcellation compared with 49 out of 59 ( 83 % ) women treated with electrosurgical resection ( odds ratio 12.5 ; 95 % confidence interval [ CI ] 1.5-100 .6 ; P = .02 ) .


The mean pain scores during the procedure favored morcellation by 16.1 points on average ( 35.9 compared with 52.0 ; 95 % CI for difference , -24.7 to -7.6 ; P < .001 ) .


Overall , 99 % of women found office polypectomy to be acceptable , with only one woman in the electrosurgical resection group considering the procedure unacceptable .


In comparison to electrosurgical resection during hysteroscopic polypectomy , morcellation was significantly quicker , less painful , more acceptable to women , and more likely to completely remove endometrial polyps compared with electrosurgical resection .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01509313 .


Plant and marine n-3 fatty acids ( FA ) may favorably modify select markers of cardiovascular disease risk .


Whether supplementing the habitual diet of lacto-ovo-vegetarians ( LOV ) with walnuts ( containing - linolenic acid , ALA ) and n-3 FA enriched eggs ( containing primarily docosahexaenoic acid , DHA and ALA ) would have equivalent effects on CVD risk factors is explored in this study .


In this study , 20 healthy free-living LOVs following their habitual diet were randomly assigned in a crossover design to receive one of three supplements : n-3 FA enriched egg ( 6/week ) , walnuts ( 28.4 g , 6/week ) or a standard egg , 6/week ( control ) for 8 weeks each with 4-wk washout between treatments .


Erythrocyte membrane fatty acids , serum lipids and inflammatory markers were measured at the end of each treatment .


Dietary compliance was observed by an expected increase in erythrocyte membrane ALA following the walnut treatment and in DHA following the n-3 FA enriched egg treatment .


Walnut treatment lowered serum triacylglycerol , total cholesterol and Apo B ( p < 0.05 ) compared to the standard egg but not the n-3 FA enriched egg treatment .


However , walnut treatment significantly reduced total : HDL cholesterol ratio compared to both egg treatments .


There were no differences between treatments for any of the inflammatory markers .


For LOV , a direct source of DHA such as n-3 FA enriched eggs seems necessary to increase membrane levels of DHA .


However for producing an overall favorable blood lipid profile , daily consumption of a handful of walnuts rich in ALA may be a preferred option for lacto-ovo vegetarian .


Electrolyzed acid water ( EAW ) has been recognized to have strong bactericidal activity , and the feasibility and safety of EAW irrigation in body cavities has been reported in the literature .


This study was conducted to evaluate the effect of EAW nasal irrigation on the postoperative care of functional endoscopic sinus surgery ( FESS ) .


Patients with chronic rhinosinusitis who received FESS for treatment were recruited and randomly assigned to three groups at 1 month postoperatively .


Patients in group 1 received EAW for nasal irrigation daily for 2 months , those in group 2 received neutral normal saline ( NS ) daily for 2 months , and those in group 3 did not receive nasal irrigation after surgery .


Before and 3 months after FESS , sinonasal symptoms were assessed by questionnaire and patients received endoscopic examination , acoustic rhinometry , smell test , saccharine transit test , and bacterial culture from middle meatus .


There were 185 patients enrolled between May 2009 and March 2012 .


Among the patients who completed the study , 36 received EWA irrigation , 35 received NS irrigation , and 39 ( group 3 ) received no irrigation .


Patients with nasal irrigation had a better outcome based on questionnaire score and saccharine transit time .


However , there was no difference in outcome between patients who received irrigation with EAW and NS .


Our study showed that EWA irrigation did not confer a greater benefit than that of NS irrigation in post-FESS care .


The ICEpop CAPability measure for Older people ( ICECAP-O ) and the Adult Social Care Outcomes Toolkit ( ASCOT ) are preference-based measures for assessing quality of life ( QOL ) from a broader perspective than do traditional health-related QOL measures such as the EuroQol five-dimensional questionnaire ( EQ-5D ) .


Measurement properties of these instruments have not yet been directly compared .


The purpose of this study was to compare the test-retest reliability , construct validity , and responsiveness of the three-level EQ-5D ( EQ-5D-3L ) , ICECAP-O , and ASCOT in frail older adults living at home .


Cross-sectional data and longitudinal data were used .


Parameters for reliability ( the intraclass correlation coefficient ) and agreement ( standard error of measurement ) were used to assess test-retest reliability after 1 week .


We formulated hypotheses about correlations with other measures and tested these to assess construct validity and responsiveness ( longitudinal validity ) .


The reliability parameters for all three scales were considered good ( intraclass correlation coefficient values above 0.70 ) .


Standard error of measurement values were less than 10 % of the scale .


Hypotheses regarding construct validity were in general accepted ; the EQ-5D-3L was more strongly associated with physical limitations than were ICECAP-O and ASCOT and less strongly with instruments measuring aspects beyond health .


Longitudinally , as hypothesized , mental health was most strongly associated with ICECAP-O , and self-perceived QOL , mastery , and client-centeredness of home care most strongly with ASCOT .


Our findings support the adoption of ICECAP-O and ASCOT as outcome measures in economic evaluations of care interventions for older adults that have a broader aim than health-related QOL because they are at least as reliable as the EQ-5D-3L and are associated with aspects of QOL broader than health .


To compare the ocular wave-front of eyes with silicone Intraocular lens ( IOLs ) with aspheric and spherical optics after cataract surgery , taking into account the patient 's pupil size under reading conditions and after pupil dilatation .


In this institutional prospective , randomized , controlled , patient and examiner masked , bilateral trial with intra-individual comparison , 60 eyes of 30 patients with bilateral age-related cataract were included .


Each patient received a spherical IOL ( CeeOn Edge , 911A , AMO , Santa Ana , CA , USA ) in one eye and an aspheric IOL ( Tecnis , Z9000 , AMO ) in the contra-lateral eye .


Exclusion criteria were other ocular pathologies , capsular changes or zonular weakness .


The main outcome variable was spherical aberration of the ocular wave-front under mesopic pupil conditions measured 2 years after surgery .


Additional outcome variables were visual acuity and photopic and mesopic contrast sensitivity .


There was no significant difference in visual acuity between the two IOL types under physiological pupil conditions and also not after pupil dilation .


However , spherical aberrations were significantly lower with the aspheric IOL ( SA : spherical 0.38 m , SD : 0.11 m ; aspheric 0.10 m , SD : 0.13 m ; p < 0.01 ) , and there was a significant difference in contrast sensitivity at 12 cycles/degree .


This is the first randomized and masked trial on visual function and ocular wave-front after implantation with this silicone aspheric IOL , taking the patients ' own pupil size into account .


The effect on visual function was detectable for mesopic contrast sensitivity , but there was no difference in visual acuity .


The SA was found to be significantly lower under physiological pupil conditions as well as when recalculated for the rhexis size and under pharmacological dilatation .


Hyperglycemia is a common , but not well-characterized side effect of glucocorticoid treatment .


To study the effect of pulse dexamethasone treatment on carbohydrate metabolism among multiple myeloma patients .


A randomized crossover observational study in a teaching hospital with nine myeloma patients ( one male , two with known type 2 diabetes ( KDM ) , mean age 69.0 6.7 years ) were investigated using a standard 75 g Oral Glucose Tolerance Test ( patients without KDM ) and a 3-day continuous glucose monitoring ( CGM -- all patients ) during and between dexamethasone cycles .


During dexamethasone treatment patients had elevated 2-h postload glucose ( 12.8 4.7 vs. 8.7 3.2 mmol/L , P = 0.024 ) but similar fasting glucose ( 6.3 1.4 vs. 5.1 0.5 mmol/L , P = 0.112 ) .


Estimated hourly mean interstitial glucose values based on linear mixed models showed an increase of 0.03 [ SE 0.01 ] mmol/L per hour from 5.0 [ 0.4 ] in patients without KDM and followed a quadratic curve from 5.0 [ 0.4 ] mmol/L at midnight to 7.5 [ 0.5 ] mmol/L at 12:00 h in patients with KDM during control periods .


During dexamethasone treatment glucose was similar to control periods between 02:00 and 12:00 h in the non-KDM group , where they followed a cubic trajectory from 5.3 [ 0.4 ] mmol/L at 04:00 h to 7.3 [ 0.4 ] mmol/L at 18:00 h.


In contrast , interstitial glucose was increased by at least 7.9 [ 0.3 ] mmol/L throughout the day in KDM patients during dexamethasone treatment and increased from 13.6 [ 0.5 ] mmol/L at midnight to 17.5 [ 0.5 ] mmol/L at 17:00 h.


During pulse steroid therapy of myeloma patients without KDM afternoon and evening glucose measurements may be the optimal tools to characterize glucose metabolism .


To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes .


Randomized , placebo-controlled , double-masked clinical trial .


This multicenter trial compared 1.0 % prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization .


The primary endpoint was 3 months from enrollment , and 399 patients were evaluated at 12 months .


The outcomes examined were best spectacle-corrected visual acuity ( BSCVA ) and scar size at 12 months .


Based on previous results , regression models with adjustments for baseline status and/or causative organism were used for analysis .


No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models ( BSCVA : -0.04 logMAR , 95 % CI , -0.12 to 0.05 , P = .39 ; scar size : 0.03 mm , 95 % CI , -0.12 to 0.18 , P = .69 ) .


A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers ( -0.10 logMAR , 95 % CI , -0.19 to -0.02 , P = .02 ) .


No significant difference was observed in 12-month BSCVA for Nocardia ulcers ( 0.18 logMAR , 95 % CI , -0.04 to 0.41 , P = .16 ) .


Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers ( 0.47 mm , 95 % CI , 0.06-0 .88 , P = .02 ) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers ( -0.06 mm , 95 % CI , -0.21 to 0.10 , P = .46 ) .


Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species .


What participants think about the nature of a study might affect their behaviour and bias findings .


We tested two hypotheses : ( 1 ) participants told they were in an intervention trial would report lower alcohol consumption at follow-up than those told they were in a cohort study ; ( 2 ) participants told they were in the intervention group in a trial would have lower alcohol consumption at follow-up than those told they were in the control group .


Students from four universities ( N = 72,903 ) were invited to participate in a ` research project on student drinking ' .


Of 10,415 respondents , 6,788 were moderate to heavy drinkers and were randomized .


Group A ( ` cohort ' ) were informed their drinking would be assessed at baseline and again in one month .


Group B ( ` control ' ) were told the study was an intervention trial and they were in the control group .


Group C ( ` intervention ' ) were told the study was an intervention trial and they were to receive the intervention .


All were assessed and directed to read identical online alcohol education material .


Whether and how long they accessed the material were recorded .


One month later , alcohol intake was reassessed .


In relation to hypothesis 1 , there were no differences between the groups on the prespecified outcome measures .


In relation to hypothesis 2 , there were no differences though all point estimates were in the hypothesized direction ( that is , ` intervention ' < ` control ' ) .


The ` cohort ' and ` control ' groups accessed the material to a similar extent ( 59 % versus 57 % ) while the ` intervention ' group were more likely to access it ( 78 % ) and to read it for longer ( median 35 s ( 25th and 75th percentiles : 6 , 97 ) versus medians of 7 s ( 0 , 28 ) and 8 s ( 4 , 42 ) for the ` cohort ' and ` control ' groups , respectively ) .


Although the context given to the research participants significantly influenced access to the online information and reading time , this did not translate into any effect on drinking behaviour , for either hypothesis .


This might be because of failure in the experimental paradigm or the possibility of weaker effects using the online approach .


Australian New Zealand Clinical Trials Registry ACTRN12610000846022 .


Advances in technology present opportunities to develop and test innovative teaching methods .


We sought to evaluate whether text messaging could improve medical resident knowledge in musculoskeletal medicine .


Eleven U.S. family medicine residency programs with a total of 269 residents participated in this randomized , controlled trial .


Residents were invited to complete a pretest to assess musculoskeletal medicine knowledge .


The residents randomized to the intervention group were then offered to receive text messages termed electronically Generated Educational Messages ( eGEMs ) three times per week during a 12-week period .


The primary outcome was change in pretest and posttest scores among residents in an intervention group ( those who received text messages ) as compared to a control group ( those who did not receive the text messages ) .


Focus groups were conducted to assess resident acceptability and usefulness of text messaging as a teaching tool .


Sixty-three residents completed the pretests and posttests .


The intervention group 's score improved from 55 % of questions answered correctly to 64 % ; the control group improved from 56 % to 61 % .


While these pretest/posttest changes each were statistically significant , the difference in improvement between the two groups was not .


Focus groups revealed that participants liked the intervention , but suggestions for improvement included ability to tailor the eGEMs .


The use of eGEMs as initially developed did not increase resident knowledge based on exam scores .


Further study is needed to determine if a more tailored intervention is effective .


We evaluated the effect of dual , longacting inhaled bronchodilator treatment on exacerbations in patients with severe and very severe chronic obstructive pulmonary disease ( COPD ) .


In this parallel-group study , 2224 patients ( aged 40 years , Global Initiative for Chronic Obstructive Lung Disease stages III-IV , and one or more moderate COPD exacerbation in the past year ) were randomly assigned ( 1:1:1 ; via interactive voice response or web system ; stratified for smoking status ) to once-daily QVA149 ( fixed-dose combination of indacaterol 110 g and glycopyrronium 50 g ) , glycopyrronium 50 g , or tiotropium 18 g for 64 weeks .


Assignment to QVA149 and glycopyrronium was double-blind ; tiotropium was open-label .


Efficacy was assessed in all patients randomly assigned to treatment groups who received at least one dose of study drug ; safety was assessed in all patients who received at least one dose whether or not they were assigned to a group .


The primary objective was to show superiority of QVA149 versus glycopyrronium for rate of moderate to severe COPD exacerbations ( defined by worsening symptoms and categorised by treatment requirements ) during treatment .


This completed trial is registered at ClinicalTrials.gov , NCT01120691 .


Between April 27 , 2010 , and July 11 , 2012 , 741 patients were randomly assigned to receive QVA149 , 741 to receive glycopyrronium , and 742 to receive tiotropium ( 729 , 739 , and 737 patients , respectively , analysed for efficacy ) .


QVA149 significantly reduced the rate of moderate to severe exacerbations versus glycopyrronium by 12 % ( annualised rate of exacerbations 084 [ 95 % CI 075-094 ] vs 095 [ 085-106 ] ; rate ratio 088 , 95 % CI 077-099 , p = 0038 ) .


Adverse events ( including exacerbations ) were reported for 678 ( 93 % ) of 729 patients on QVA149 , 694 ( 94 % ) of 740 on glycopyrronium , and 686 ( 93 % ) of 737 on tiotropium .


Incidence of serious adverse events was similar between groups ( 167 [ 23 % ] patients on QVA149 , 179 [ 24 % ] on glycopyrronium , and 165 [ 22 % ] on tiotropium ) ; COPD worsening was the most frequent serious adverse event ( 107 [ 15 % ] patients on QVA149 , 116 [ 16 % ] on glycopyrronium , 87 [ 12 % ] on tiotropium ) .


The dual bronchodilator QVA149 was superior in preventing moderate to severe COPD exacerbations compared with the single longacting antimuscarinic bronchodilator glycopyrronium , with concomitant improvements in lung function and health status .


These results indicate the potential of dual bronchodilation as a treatment option for patients with severe and very severe COPD .


Novartis Pharma AG .


Emerging data suggest instillation of tissue plasminogen activator ( tPA ) is safe and potentially efficacious in the treatment of intra-abdominal abscess .


To date , prospective comparative data are lacking in children .


Therefore , we conducted a randomized trial comparing abscess irrigation with tPA and irrigation with saline alone .


After IRB approval , children with an abscess secondary to perforated appendicitis who had a percutaneous drain placed for treatment were randomized to twice-daily instillation of 13 mL 10 % tPA or 13 mL normal saline .


All patients were treated with once-daily dosing of ceftriaxone and metronidazole throughout their course .


The primary end point variable was duration of hospitalization after drain placement .


Using a power of 0.8 and an of 0.05 , a sample size of 62 patients was calculated .


Sixty-two patients were enrolled between January 2009 and February 2013 .


There were no differences in demographics , abscess size , abscess number , admission WBC , or duration of symptoms .


Duration of hospitalization after drainage was considerably longer with the use of tPA .


There was no difference in total duration of hospitalization , days of drainage , or days of antibiotics .


However , medication charges were higher with tPA .


There are no advantages to routine tPA flushes in the treatment of abdominal abscess secondary to perforated appendicitis in children .


Inflammation may contribute to the pathogenesis of diabetic retinopathy ( DR ) .


To investigate , in a proof-of-concept clinical trial , whether low-dose oral doxycycline monohydrate can ( 1 ) slow the deterioration of , or improve , retinal function or ( 2 ) induce regression or slow the progression of DR in patients with severe nonproliferative DR ( NPDR ) or non-high-risk proliferative ( PDR ) , and to determine the potential usefulness of visual function end points to expedite the feasibility of conducting proof-of-concept clinical trials in patients with DR.


We conducted a randomized , double-masked , 24-month proof-of-concept clinical trial .


Thirty patients ( from hospital-based retina practices ) with 1 or more eyes with severe NPDR or PDR less than Early Treatment Diabetic Retinopathy Study-defined high-risk PDR .


Patients were randomized to receive 50 mg of doxycycline monohydrate or placebo daily for 24 months .


Change at 24 months compared with baseline in functional factors ( frequency doubling perimetry [ FDP ] , Humphrey photopic Swedish Interactive Thresholding Algorithm 24-2 testing , contrast sensitivity , dark adaptation , visual acuity , and quality of life ) and anatomic factors ( Early Treatment Diabetic Retinopathy Study DR severity level , area of retinal thickening , central macular thickness , macular volume , and retinal vessel diameters ) .


From baseline to month 24 , mean FDP foveal sensitivity decreased in the placebo group ( -1.9 dB ) and increased in the doxycycline group ( +1.8 dB ) ( P = .02 ) .


A higher mean FDP foveal sensitivity in the doxycycline group compared with the placebo group was detected at 6 months ( P = .04 ) , and this significant difference persisted at 12 and 24 months .


A difference between the groups was not detected with respect to the other visual function outcomes and all anatomic outcomes assessed .


To our knowledge , this is the first observation suggesting a link between a low-dose oral anti-inflammatory agent and subclinical improvement in inner retinal function .


Oral doxycycline may be a promising therapeutic strategy targeting the inflammatory component of DR. Furthermore , study results suggest that FDP , which primarily measures inner retinal function , is responsive to intervention and may be a useful clinical trial end point for proof-of-concept studies in patients with DR.


clinicaltrials.gov Identifier : NCT00511875 .


In Rivaroxaban Once Daily Oral Direct Factor Xa Inhibitor Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET AF ) trial , rivaroxaban was noninferior to dose-adjusted warfarin in preventing stroke or systemic embolism among patients with nonvalvular atrial fibrillation at moderate to high stroke risk .


Because of differences in patient demographics , epidemiology , and stroke risk management in East Asia , outcomes and relative effects of rivaroxaban versus warfarin were assessed to determine consistency among East Asians versus other ROCKET AF participants .


Baseline demographics and interaction of treatment effects of rivaroxaban and warfarin among patients within East Asia and outside were assessed .


A total of 932 ( 6.5 % ) ROCKET AF participants resided in East Asia .


At baseline , East Asians had lower weight , creatinine clearance , and prior vitamin K antagonist use ; higher prevalence of prior stroke ; and less congestive heart failure and prior myocardial infarction than other participants .


Despite higher absolute event rates for efficacy and safety outcomes in East Asians , the relative efficacy of rivaroxaban ( 20 mg once daily ; 15 mg once daily for creatinine clearance of 30-49 mL/min ) versus warfarin with respect to the primary efficacy end point ( stroke/systemic embolism ) was consistent among East Asians and non-East Asians ( interaction P = 0.666 ) .


Relative event rates for the major or nonmajor clinically relevant bleeding in patients treated with rivaroxaban and warfarin were consistent among East Asians and non-East Asians ( interaction P = 0.867 ) .


Observed relative efficacy and safety of rivaroxaban versus warfarin were similar among patients within and outside East Asia .


Rivaroxaban , 20 mg once daily , is an alternative to warfarin for stroke prevention in East Asians with nonvalvular atrial fibrillation .


http://www.clinicaltrials.gov .


Unique identifier : NCT00123456 .


Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery .


Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and , in Australia , is utilized most frequently for privately insured patients .


With the exception of comparisons with domiciliary services , no randomized trial has compared inpatient rehabilitation to any outpatient based program .


The Hospital Inpatient versus HOme ( HIHO ) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test ( 6MWT ) compared to a hybrid home program alone following total knee arthroplasty .


Secondarily , the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function .


This is a two-arm parallel randomized controlled trial ( RCT ) , with a third , non-randomized , observational group .


One hundred and forty eligible , consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care ( a 6-week hybrid home program ) or to usual care .


Seventy participants in each group ( 140 in total ) will provide 80 % power at a significance level of 5 % to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups , respectively , in the 6MWT at 6 months post-surgery , assuming a SD of 120 m and a drop-out rate of < 10 % .


The outcome assessor will assess participants at 10 , 26 and 52 weeks post-operatively , and will remain blind to group allocation for the duration of the study , as will the statistician .


Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together with any baseline differences in potentially confounding characteristics as required .


The HIHO Trial will be the first RCT to investigate the efficacy of inpatient rehabilitation compared to any outpatient alternative following total knee arthroplasty .


U.S. National Institutes of Health Clinical Trials Registry ( http://clinicaltrials.gov ) ref : NCT01583153 .


The aim of the study was to compare the efficacy of the TruView EVO2 , TruView PCD , and Miller laryngoscopes for tracheal intubation during cardiopulmonary resuscitation with and without chest compressions ( CCs ) by paramedics in an infant manikin model .


This was an open , prospective , randomized , simulated trial .


After a brief didactic session , 78 volunteer paramedics attempted to intubate a manikin using TruView EVO2 , TruView PCD , and Miller laryngoscopes during resuscitation with and without CC scenarios .


Primary end point was intubation success rate and secondary was time to intubation with each device .


Glottic view using a Cormack-Lehane grade in using each device was also assessed .


In scenario with uninterrupted CCs , the median time to intubation using the TruView EVO2 , TruView PCD , and Miller varied with the times being 25.3 seconds ( interquartile range [ IQR ] , 23-30 .5 seconds ) vs 20.2 seconds ( IQR , 18-23 seconds ) vs 24.4 seconds ( IQR , 21-28 seconds ) , respectively .


The overall success rate of intubation during CC for the devices were 94.9 % vs 100 % vs 92.1 % .


During intubation without CC , median time to intubation varied and amounted to 24.9 seconds ( IQR , 21-29 .6 seconds ) for TruView EVO2 , 18.3 seconds ( IQR , 16-21 .3 seconds ) for TruView PCD , and 19.4 seconds ( IQR , 17-23 .3 seconds ) for Miller laryngoscope .


The overall success rate of intubation without CC for all devices was 100 % .


For infant tracheal intubation with TruView PCD , when used by paramedics , the malleable TruView PCD showed shorter intubation time and higher overall success rate in a simulated CC scenario than TruView EVO2 or Miller laryngoscopes .


Further clinical studies are necessary to confirm these initial positive findings .


This study evaluates the efficacy of the Choose Health program , a family-based cognitive behavioural lifestyle program targeting improved eating and activity habits , in improving body composition , cardiovascular fitness , eating and activity behaviours in overweight and obese adolescents .


The sample comprised 29 male and 34 female overweight ( n = 15 ) or obese ( n = 48 ) adolescents aged 11.5-18 .9 years ( M = 14.3 , SD = 1.9 ) .


Participants were randomly allocated to treatment or waitlist control conditions ; waitlist condition participants were offered treatment after 6 months .


DEXA-derived and anthropometric measures of body composition ; laboratory-based cycle ergometer and field-assessed cardiovascular fitness data ; objective and self-report physical activity measures ; and self-report measures of eating habits and 7-day weighed food diaries were used to assess treatment outcome .


Adherence to treatment protocols was high .


Treatment resulted in significant ( p < .05 ) and sustained improvements in a range of body composition ( body fat , percent body fat , lean mass ) and anthropometric measures ( weight , BMI , BMI-for-age z-score and percentiles ) .


Minimal improvements were seen in cardiovascular fitness .


Similar results were obtained in completer and intention-to-treat analysis .


Poor adherence to assessment protocols limits conclusions that can be drawn from physical activity and dietary data .


Participation in the Choose Health program resulted in significant improvement in body composition .


Longer-term follow up is required to determine the durability of intervention effects .


Alternative approaches to the measurement of diet and physical activity may be required for adolescents .


Compare the safety and efficacy of 1 % and 5 % silica encapsulated benzoyl peroxide ( E-BPO ) in patients with papulopustular rosacea .


Multi-centered randomized , double blind , vehicle controlled parallel group , 12 week treatment in 92 patients with papulopustular rosacea .


Primary endpoints were dichotomized IGA with success defined as clear/near clear and reduction in inflammatory lesions .


92 patients : 74 % graded as moderate IGA , 14 % severe and 12 % mild .


The mean inflammatory lesion count was 24 .


Once daily treatment for 12 weeks with vehicle , 1 % or 5 % E-BPO .


1 % and 5 % E-BPO were superior to vehicle in reducing papulopustular lesions P = 0.01 and P = 0.02.5 % E-BPO was superior to vehicle for IGA P = 0.0013 .


Patients discharged from the emergency department ( ED ) are often referred for primary care , specialty , or other disease-specific follow-up appointments .


Attendance at these scheduled follow-up appointments has been found to improve patient outcomes , decrease ED bounce-backs , and reduce malpractice risk .


Reasons for missing follow-up visits are complex , but the most commonly reason cited by patients is simply forgetting .


In this study the authors evaluated the ability of an automated text message reminder system to increase attendance at post-ED discharge follow-up appointments in a predominantly Hispanic safety-net population .


This was a randomized controlled trial of ED patients with outpatient follow-up visits scheduled at the time of ED discharge .


A total of 374 English - and Spanish-speaking patients with text-capable mobile phones were enrolled .


Patients in the intervention arm received automated , personalized text message appointment reminders including date , time , and clinic location at 7 , 3 , and 1 day before scheduled visits .


A t-test of proportions was used to compare outcomes between intervention and control groups .


Both an intention-to-treat ( ITT ) and a per-protocol analysis of the data were performed .


The ITT more accurately reflects real-world conditions where errors such as number entry errors are bound to occur .


The per-protocol analysis adds value by isolating the effect of the intervention by comparing patients who actually received it compared with those who did not .


In the per-protocol analysis of the primary outcome , the overall appointment adherence rate was 72.6 % in the intervention group compared with 62.1 % in the control group ( difference between groups = 10.5 % , 95 % confidence interval [ CI ] = 0.3 % to 20.8 % ; p = 0.045 ; number needed to treat = 9.5 ) .


In the ITT analysis , the overall appointment attendance rate 70.2 % in the intervention group compared with 62.1 % in the control group ( difference between groups = 8.2 % ; 95 % CI = -1.6 % to 17.7 % ; p = 0.100 ) .


In a secondary largely exploratory analysis , the intervention was found to have the most benefit in patients with the lowest baseline follow-up rate ( English speakers with specialty care appointments ) .


Automated text message appointment reminders resulted in improvement in attendance at scheduled post-ED discharge outpatient follow-up visits and represent a low-cost and highly scalable solution to increase attendance at post-ED follow-up appointments , which should be further explored in larger sample sizes and diverse patient populations .


Stress , depression , and anxiety affect 15 to 25 % of pregnant women .


However , fewer than 20 % of prenatal care providers assess and treat mental health problems and fewer than 20 % of pregnant women seek mental healthcare .


For those who seek treatment , the lack of health system integration and existing barriers frequently prevent treatment access .


Without treatment , poor prenatal mental health can persist for years and impact future maternal , child , and family well-being .


The purpose of this randomized controlled trial is to evaluate the effectiveness of an integrated process of online psychosocial assessment , referral , and cognitive behavior therapy ( CBT ) for pregnant women compared to usual prenatal care ( no formal screening or specialized care ) .


The primary outcome is self-reported prenatal depression , anxiety , and stress symptoms at 6 to 8 weeks postrandomization .