Whites reported significantly better average comfort ( P = 0.046 ) and less dryness ( P < 0.001 ) than did Asians .


Asians and whites differ in both ocular response to the use of contact lens care solutions and in reporting subjective symptoms .


Racial and ethnic differences should be considered when evaluating and treating contact lens patients in a clinical setting .


The purpose of this study was to evaluate the efficacy of periarticular multimodal drug injection after medial opening-wedge high tibial osteotomy regarding the postoperative pain level .


From January 2011 to January 2012 , 70 patients underwent medial opening-wedge high tibial osteotomy .


Thirty-five patients were randomly assigned to receive no injection ( group I ) , and 35 patients were assigned to receive periarticular multimodal drug injection ( group II ) .


These 2 groups were compared regarding the postoperative pain level , frequency of additional nonsteroidal anti-inflammatory drug injections , total amount of patient-controlled analgesia , and number of times that patients pushed the patient-controlled analgesia button at each time interval .


Statistical results were based on multivariate analysis of variance and repeated-measures analyses .


Multivariate analysis of variance of mean visual analog scale ( VAS ) scores over the 2-week postoperative period showed statistical significance ( P < .001 ) .


Repeated-measures analysis yielded a statistically significant difference ( P = .001 ) for the time-by-treatment interaction , showing a clear periarticular multimodal drug injection benefit over time based on VAS scores .


In addition , the mean number of times that patients pushed the patient-controlled analgesia button differed significantly between groups over time ( P = .01 ) .


The VAS scores , frequency of additional nonsteroidal anti-inflammatory drug injections , mean number of times that patients pushed the patient-controlled analgesia button , and mean total amount of fentanyl consumption differed significantly within each group over time ( P < .001 for all variables ) .


However , the frequency of additional nonsteroidal anti-inflammatory drug injections and mean total amount of fentanyl consumption did not differ significantly between groups over time ( P = .822 , P = .529 , and P = .282 ) .


Opioid - and injection-related complications were not found .


This prospective randomized study shows that intraoperative periarticular multimodal drug injections in patients undergoing medial opening-wedge high tibial osteotomy for unicompartmental osteoarthritis of the knee could result in significant reductions in VAS scores at 2weeks postoperatively .


Level I , high-quality randomized controlled trial with statistically significant differences .


Desflurane is the least soluble and most expensive inhalation agent .


Hence , low flow technique is suitable for anesthesia with desflurane .


However , one of the disadvantages of low flow technique is the discrepancy among the end-tidal concentration , inspired concentration , and vaporizer setting .


To measure the concentrations of desflurane at different sites of the anesthesia circuit by varying fresh gas flow ( FGF ) rates but fixing expired concentration .


Thirty ASA PS I-II adult patients were enrolled in this crossover study .


After induction of anesthesia and ten minutes of wash-in period , the flow meters of oxygen and air were then adjusted to maintain FiO2 at 0.3 with the random sequences of FGF rates at 0.5 , 1 and 2 L x min ( -1 ) .


Desflurane vaporizer was adjusted to obtain 5 % end-tidal desflurane concentration ( FeDES ) throughout the study period .


After FeDES reached the target and was stable for 20 minutes , inspired concentration ofdesflurane ( FiDES ) and delivered desflurane concentration at fresh gas outlet ( FdDES ) were measured .


Lastly , the consumption of desflurane was calculated .


FdDES was higher than FiDES in every FGF rates .


FdDES at FGF 0.5 L x min ( -1 ) ( 6.13 + / - 0.12 ) was significantly higher than FdDES at 1 and 2 L x min ( -1 ) ( 5.68 + / - 0.08 , 5.54 + / - 0.07 , respectively ) , but not significantly different between FGF 1 and 2 L x min ( -1 ) .


FeDES/FdDES at FGF 0.5 , 1 and 2 L.min ( -1 ) were 0.82 + / - 0.014 , 0.88 + / - 0.012 and 0.87 + / - 0.011 , respectively .


There was no significant difference of FeDES/FdDES between FGF 1 and 2 L x min ( -1 ) , but there was significant difference between FGF 1 and 0.5 L x min ( -1 ) with the p-value < 0.001 .


The calculated liquid desflurane consumption per hour at FGF rate of 0.5 , 1 and 2 L x min ( -1 ) were 8.77 + / - 0.17 , 16.28 + / - 0.24 and 31.73 + / - 0.41 mL x hr ( -1 ) .


Using FGF 2 L x min ( -1 ) has no advantage over FGF 1 L x min ( -2 ) , because they both have the similar FdDES .


Regarding at FGF 0.5 and 1 L x min ( -1 ) , the delivered concentration has to be increased to obtain the desired expired concentration with more intense at FGF 0.5 L x min ( -1 ) because there are more discrepancies between FdDES and FeDES .


Increased oxidative stress and inflammation has a role in the pathogenesis of chronic obstructive pulmonary disease ( COPD ) .


Drugs with antioxidant and anti-inflammatory properties , such as N-acetylcysteine , might provide a useful therapeutic approach for COPD .


We aimed to assess whether N-acetylcysteine could reduce the rate of exacerbations in patients with COPD .


In our prospective , randomised , double-blind , placebo-controlled , parallel-group study , we enrolled patients aged 40-80 years with moderate-to-severe COPD ( post-bronchodilator forced expiratory volume in 1 s [ FEV1 ] / forced vital capacity < 07 and FEV1 of 30-70 % of predicted ) at 34 hospitals in China .


We stratified patients according to use of inhaled corticosteroids ( regular use or not ) at baseline and randomly allocated them to receive N-acetylcysteine ( one 600 mg tablet , twice daily ) or matched placebo for 1 year .


The primary endpoint was the annual exacerbation rate in patients who received at least one dose of study drug and had at least one assessment visit after randomisation .


This study is registered with the Chinese Clinical Trials Registry , ChiCTR-TRC-09000460 .


Between June 25 , 2009 , and Dec 29 , 2010 , we screened 1297 patients , of whom 1006 were eligible for randomisation ( 504 to N-acetylcysteine and 502 to placebo ) .


After 1 year , we noted 497 acute exacerbations in 482 patients in the N-acetylcysteine group who received at least one dose and had at least one assessment visit ( 116 exacerbations per patient-year ) and 641 acute exacerbations in 482 patients in the placebo group ( 149 exacerbations per patient-year ; risk ratio 078 , 95 % CI 067-090 ; p = 00011 ) .


N-acetylcysteine was well tolerated : 146 ( 29 % ) of 495 patients who received at least one dose of N-acetylcysteine had adverse events ( 48 serious ) , as did 130 ( 26 % ) of 495 patients who received at least one dose of placebo ( 46 serious ) .


The most common serious adverse event was acute exacerbation of COPD , occurring in 32 ( 6 % ) of 495 patients in the N-acetylcysteine group and 36 ( 7 % ) of 495 patients in the placebo group .


Our findings show that in Chinese patients with moderate-to-severe COPD , long-term use of N-acetylcysteine 600 mg twice daily can prevent exacerbations , especially in disease of moderate severity .


Future studies are needed to explore efficacy in patients with mild COPD ( GOLD I ) .


Hainan Zambon Pharmaceutical .


Optimal positioning of orthodontic mini-implants is essential for a successful treatment with skeletal anchorage .


This study aims to compare the accuracy of two-dimensional radiographs with a cone beam computed tomography ( CBCT ) for mini-implant placement .


An ideal site for mini-implant placement at the buccal interradicular space between the second premolar and the first molar was determined for 40 sites ( in 13 patients aged 14 to 28 years ) by using CBCT data .


The mini-implant placement procedure was then divided into two groups .


In CBCT group , mini-implants were placed at the sites determined from CBCT data .


In RVG group , mini-implants were placed with the help of two-dimensional digital radiographs and a custom made guide .


Postplacement CBCT scans were obtained to determine the accuracy of the mini-implant placement .


The results were statistically analyzed with a Mann-Whitney test .


A statistically significant difference ( p value = 0.02 ) was observed between the two groups for deviation from an ideal height of placement of the mini-implants .


Deviations in mesiodistal positioning and angular deviation showed a statistically non-significant difference .


Three out of twenty mini-implants in the RVG group showed root contact in the mandibular arch that may be attributed to the narrower interradicular space and reduced accessibility in the mandibular posterior region .


Although CBCT provides an accurate three-dimensional visualization of the interradicular space , the two-dimensional intraoral radiograph of the interradicular area provides sufficient information for mini-implant placement .


Considering the amount of radiation exposure and cost with the two techniques , it is recommended to use two-dimensional radiographs with a surgical guide for a routine mini-implant placement .


The amount of epicardial adipose tissue ( EAT ) around the heart has been identified as an independent predictor of coronary artery disease ( CAD ) , potentially through local release of inflammatory cytokines .


Ethnic differences have been observed , but no studies have investigated this relationship in the Mexican population .


The objective of the present study was to evaluate whether a relationship exist between EAT thickness assessed via echocardiography with CAD and adiponectin levels in a Mexican population .


We studied 153 consecutive patients who underwent coronary angiography and transthoracic echocardiography ( TTE ) .


EAT thickness on the free wall of the right ventricle was measured at the end of systole from parasternal long and short axis views of three consecutive cardiac cycles .


Coronary angiograms were analyzed for the presence , extent and severity of CAD .


Serum adiponectin , lipids , glucose , C-reactive protein and fibrinogen were determined .


EAT thickness was greater in patients with CAD than in those without CAD from both parasternal long ( 5.39 1.75 mm vs 4.00 1.67 mm p < 0.0001 ) and short-axis views ( 5.23 1.67 vs 4.12 1.77 , p = 0.001 ) .


EAT thickness measured from parasternal long and short-axis showed a statistically significant positive correlation with age ( r = 0.354 , p < 0.001 ; r = 0.286 , p < 0.001 respectively ) , and waist circumference ( r = 0.189 , p = 0.019 ; r = 0.217 , p = 0.007 respectively ) .


A significant negative correlation between EAT thickness from the parasternal long axis with cholesterol-HDL was observed ( r = -0.163 , p = 0.045 ) .


No significant correlation was found between epicardial fat thickness and serum adiponectin or with the severity of CAD .


EAT thickness was greater in patients with CAD .


However , no correlation was observed with the severity of the disease or with serum adiponectin levels .


EAT thickness measured by echocardiography might provide additional information for risk assessment and prediction of CAD .


To compare the level of sedation , cardiorespiratory changes , and quality of recovery in cats receiving methadone plus either low dose tiletamine-zolazepam or acepromazine for premedication prior to general anaesthesia for neutering .


Prospective , randomized , blinded clinical study .


Twenty cats 0.54 0.12 years-old ( mean SD ) , weighing 3.17 0.65 kg ( 10 male and 10 female ) .


Cats were allocated randomly to receive intramuscularly either 0.03 mg kg ( -1 ) acepromazine ( ACE ) or 3 mg kg ( -1 ) tiletamine-zolazepam ( TZ ) , both regimens combined with 0.2 mg kg ( -1 ) methadone for premedication .


Sedation was assessed 25 minutes after premedication using a visual analogue scale ( VAS ) and a simple descriptive scale ( SDS ) .


Anaesthesia was induced with alfaxalone and maintained with isoflurane .


Physiological parameters were recorded at 1 , 3 and 5 minutes post-endotracheal intubation .


Recovery from cessation of isoflurane was timed and quality assessed using a SDS and a VAS .


Data was analysed with Mann-Whitney U-test , students t-test , anova or ordinal logistic regression as relevant .


Significance was taken as p < 0.05 .


Sedation was more pronounced in TZ than ACE as indicated by higher VAS ( 67 21 versus 13 5 ) and SDS scores [ 4 ( 1-4 ) versus 1 ( 0-1 ) ] .


Following sedation , Heart ( HR ) and respiratory ( fR ) rates did not differ between groups .


After anaesthetic induction , at times 1 , 3 and 5 HR , systolic arterial pressure and end tidal carbon dioxide were significantly higher and fR was significantly lower in TZ than ACE .


Recovery quality was similar between groups .


In both groups , times to extubation , head lift and sternal recumbency were similar , but time ( minutes ) until standing was significantly longer in TZ ( 31 16 ) than ACE ( 18 11 ) .


Low dose tiletamine-zolazepam combined with methadone provided superior sedation to ACE .


Recovery quality was similar , although time to standing was longer .


We describe the safety and efficacy of the Altis ( ) Single Incision Sling System for the treatment of female stress urinary incontinence through 12months .


In this study we collected a variety of safety and efficacy measures relevant to the assessment of urinary incontinence .


The primary efficacy end point was improvement in 24-hour pad weight test .


Other efficacy measures included the cough stress test , Urogenital Distress Inventory-Short Form , Incontinence Impact Questionnaire-Short Form , Patient Global Impression of Improvement and 3-day voiding diary .


Safety was evaluated through assessment of device and procedure related adverse events .


Of 116 surgical attempts 113 subjects were implanted with the Altis sling .


Of these patients 103 had primary efficacy data at baseline and 6 months , and 101 had efficacy data at baseline and 12 months .


Consequently 88 ( 85.4 % ) subjects at 6 months and 91 ( 90.1 % ) at 12 months achieved a 50 % or greater reduction in pad weight .


The cough stress test was negative for 95 ( 92.2 % ) subjects at 6 months and 91 ( 90.1 % ) at 12 months .


A decrease in median leaks per day was observed at 6 months and improvements in all patient reported measures were observed through 12 months .


A majority of subjects reported feeling much better or very much better at 6 and 12 months , respectively .


There were no reports of mesh erosion or migration and no unanticipated adverse events through 12 months .


The Altis sling appears to be safe and efficacious , and performs asintended in the treatment of stress urinary incontinence through 12 months .


Transformation of B-cell chronic lymphocytic leukaemia ( B-CLL ) to diffuse large B cell lymphoma ( DLBCL ) ( Richter 's syndrome ( RS ) ) is a rare ( 2-15 % of patients ) but catastrophic complication of B-CLL .


Dose-intense chemotherapy regimens investigated in small single institution trials , but with the exception of bone marrow transplantation for a minority of patients , little has improved the median overall survival of patients with RS beyond eight months .


Patients are often elderly , immunosuppressed , possess co-morbidities and have a deteriorating performance status .


TP53 disruption is a common molecular abnormality noted in RS and contributes to the tumour 's chemotherapy resistance .


Ofatumumab is a fully human anti-CD20 monoclonal IgG1 antibody that targets a unique epitope on B lymphocytes .


It has displayed increased binding affinity and a longer dissociation time when compared to rituximab resulting in improved complement dependent cellular cytotoxicity ( CDCC ) ; a mechanism with the potential to overcome apoptosis-resistance in TP53 disruption .


Given the prevalence of TP53 disruption in RS , Ofatumumab was considered a relatively non-toxic agent with a sound rationale to test in a prospective multicentre trial as an adjunct to CHOP induction and subsequent ofatumumab maintenance therapy in responding patients .


The CHOP-OR study is a prospective phase II study to evaluate the safety , feasibility and activity of a CHOP chemotherapy in combination with ofatumumab in induction and subsequent maintenance for patients with newly diagnosed RS .


The primary objective will be the overall response rate ( ORR ) in patients with RS after six cycles of CHOP-O .


The secondary objectives include feasibility of recruitment , progression free survival ( PFS ) , overall survival ( OS ) and toxicity .


The study will be accompanied by exploratory analysis of the genomic landscape of RS in newly diagnosed patients .


The CHOP-OR trial evaluates the safety , feasibility and activity of CHOP plus Ofatumumab induction and Ofatumumab maintenance in new RS patients .


The study is currently recruiting and has met the interim analysis criteria , with more than 7 of the first 25 participants achieving a CR or PR after six cycles of CHOP-O .


The study has the potential to identify predictive biomarkers for this treatment modality .


NCT01171378 .


Dinaciclib ( MK-7965 , formerly SCH 727965 ) , a novel , small-molecule inhibitor of cyclin-dependent kinases , has been shown to induce apoptosis in preclinical studies of human tumor cell lines , including non-small cell lung cancer ( NSCLC ) cells .


Erlotinib , an epidermal growth factor receptor inhibitor , is approved for the treatment of advanced NSCLC as second - or third-line therapy .


This phase 2 , randomized , multicenter , open-label study compared dinaciclib with erlotinib in patients with previously treated NSCLC .


The study was comprised of 2 parts : in part 1 , patients were randomized to either intravenous ( IV ) dinaciclib ( 50 mg/m2 ) or oral erlotinib ( 150 mg ) using an adaptive Bayesian design that adjusted the randomization ratio in favor of the more active arm , and in part 2 , patients who had progressed on erlotinib were permitted to cross over to receive dinaciclib at the same dosage as in part 1 .


Patients were followed until disease progression or death , initiation of nonstudy cancer treatment , discontinuation , or withdrawal of consent .


The primary efficacy end point was time-to-progression ( TTP ) in part 1 and objective response rate ( ORR ) in part 2 .


Based on Kaplan-Meier estimates , the median TTP was 1.49 months ( 95 % confidence interval [ CI ] : 1.31 , 2.63 ) following initial treatment with dinaciclib , compared with 1.58 months ( 95 % CI : 1.38 , 2.83 ) with erlotinib .


No objective responses were observed following initial treatment with dinaciclib .


Common severe ( grade 3 or 4 ) drug-related adverse effects included neutropenia , leukopenia , vomiting , and diarrhea .


Dinaciclib , administered IV , was well tolerated at the 50 mg/m2 dose , but does not have activity as monotherapy in previously treated NSCLC .


Evaluation of dinaciclib in combination with other agents for other indications including breast cancer and multiple myeloma is in progress .


Few studies have investigated objective markers of lipodystrophy in African children .


We compared body circumferences , skin-fold thickness ( SFT ) and lipids in antiretroviral therapy ( ART ) - naive and stavudine ( d4T ) - exposed children with HIV-uninfected controls .


In the CHAPAS-3 trial , HIV-infected children ( ART-naive or on d4T for 2 years without clinical lipodystrophy ) were randomized to d4T , abacavir or zidovudine with lamivudine ( 3TC ) plus a non-nucleoside reverse transcriptase inhibitor .


Mid-upper-arm circumference ( MUAC ) and calf circumference ( CC ) , SFT ( biceps , triceps , sub-scapular and supra-iliac ) and fasting lipids ( total cholesterol [ TC ] , low-density lipoprotein [ LDL ] , high-density lipoprotein [ HDL ] and triglycerides [ TRIG ] ) were measured at randomization in all HIV-infected children , and in HIV-uninfected controls .


Age - and sex-adjusted z-scores of MUAC , CC , SFT and the sum of SFT ( SSF ) using Dutch reference data were compared across groups using linear regression .


Of 496 children , 49 % were male , 299 ( median age 2.5 years [ IQR 1.5-4 .0 ] ) were ART-naive , 109 ( median age 6 years [ IQR 5.5-7 .0 ] ) were ART-experienced and 88 ( median age 2.2 years [ IQR 1.5-3 .0 ] ) were control children .


Overall , 100 % and 95 % of ART-experienced children had been on d4T plus 3TC and nevirapine , respectively , for a median 3.5 years ( IQR 2.6-4 .2 ) .


Mean ( sd ) weight-for-age z-scores and MUAC z-scores were -1.51 ( 1.29 ) versus -0.90 ( 0.88 ) versus -0.33 ( 1.15 ) and -1.56 ( 1.25 ) versus -1.24 ( 0.97 ) versus -0.65 ( 1.06 ) in ART-naive versus - experienced versus controls , respectively ( all P < 0.02 ) .


The mean ( sd ) of SSF was lower in the ART-experienced ( -0.78 [ 1.28 ] ) than in the ART-naive ( -0.32 [ 1.09 ] ; P < 0.0001 ) children and controls ( -0.29 [ 0.88 ] ; P < 0.002 ) .


ART-experienced children had higher mean fasting TC , LDL and HDL but lower TRIG compared to ART-naive children ( P-values < 0.0001 ) , and higher TC and HDL but lower TRIG compared to controls ( P-values < 0.01 ) .


In ART-experienced children on d4T-containing regimens , we observed lower SFT and higher TC and LDL values compared to ART-naive children and HIV-uninfected controls .


The aim of this trial is to search effectiveness of specifically adapted exercise programs on its own and with low back school on pain , disability , trunk and quadriceps muscle strength , walking performance , spinal mobility , quality of life ( QOL ) , and depression in the patients with chronic low back pain ( CLBP ) .


A total of 121 patients with definite CLBP were included in this study .


The patients were randomized into two groups .


Group 1 ( n = 60 ) was given exercises only and accepted as the control group .


Group 2 ( n = 61 ) received back school program and exercises .


The exercise treatment was performed 3 days a week , for 3 months .


The pain ( visual analog scale , VAS ) , disability ( Oswestry Disability Questionnaire , ODQ ) , walking performance ( 6 minute walking test , 6MWT ) , depression ( Beck Depression Inventory scores , BDI ) , and QOL ( Short Form 36 , SF-36 ) of all participants were evaluated .


The trunk and knee muscle strength were measured with a handheld dynamometer .


Patients were assessed at baseline ( BT ) , at the end of treatment ( AT ) , and at the six month follow-up ( F ) .


Statistically significant improvements were found between groups regarding all of the clinical parameters over time .


Pain , disability , muscle strength , endurance , 6MWT , mobility , QOL , and depression of both groups also showed improvements AT .


These improvements persisted at 6-months follow-ups ( P < 0.05 ) .


There were statistically significant differences between the groups for pain , disability , muscle strength , endurance , 6MWT , QOL , and depression regarding the change scores between AT-BT test and F-BT test ( P < 0.05 ) .


Group 2 improved more than group 1 except for mobility .


Exercise programs can be modified and used successfully in CLBP and this effect can be increased with addition of back school further .


Diagnostic study Level-I-I ( prospective study ) .


To evaluate the value of exhaled nitric oxide in the severity evaluation of asthmatic children with remitting rhinitis .


A total of 214 asthmatic children were randomly allocated to a untreated control and a conventional treatment group .


Patients in each of the two subclasses were classified as asthma with concurrent rhinitis and asthma without concurrent rhinitis .


Values of the 20 % fall in forced expiratory volume in 1 second ( PC20FEV1 ) and fractional exhaled nitric oxide ( FeNO ) were measured .


The PC20FEV1 level was significantly higher in untreated asthma patients without rhinitis than in those with concurrent rhinitis ( P < 0.05 ) , while FeNO was not significantly different between these two groups ( P > 0.05 ) .


There were no significant differences in both FeNO and PC20FEV1 between treated asthma patients with and without concurrent rhinitis ( P > 0.05 ) .


PC20FEV1 was significantly increased ( P < 0.05 ) but FeNO was significantly decreased ( P < 0.05 ) in asthma patients with concurrent rhinitis after conventional treatment .


In asthmatic children without concurrent rhinitis , treatment significantly decreased the level of FeNO ( P < 0.05 ) but had not effect on PC20FEV1 ( P > 0.05 ) .


Exhaled nitric oxide measurement may be useful in the severity evaluation of asthmatic children with remitting rhinitis .


Randomized , within-in participant cross-over study .


The purpose of this study was to determine the effect on comfort and pressure of lying with the shoulders and bed in different positions for people with tetraplegia .


Rehabilitation hospital .


Twenty people with tetraplegia were tested lying supine with the shoulders and bed in seven different positions .


The positions used a combination of three arm and two bed positions .


Six of the positions reflected what is commonly recommended in acute spinal cord injury units including a crucifix-type position .


The seventh position was selected by participants and reflected their preferred sleeping position .


There were five outcomes : general comfort , shoulder comfort , participant choice of preferred position , peak pressure under the shoulders and areal pressure under the shoulders .


Pressure was measured using a pressure mapping system and comfort using a visual analogue scale ( VAS ) .


The participants reported significantly higher ( P < 0.01 ) general comfort and shoulder comfort in their self-selected position compared with all other positions .


There was no statistical difference in peak pressure ( P = 0.15 ) or areal pressure ( P = 0.08 ) under the shoulders between the seven positions .


Most participants indicated that they preferred to lie with their shoulders adducted and internally rotated and the hands either by their sides or on their stomachs .


The position of the shoulders has little effect on pressure but a notable effect on comfort .


Participants preferred to sleep with their arms beside their bodies , not with their arms in a crucifix position as commonly advocated .


To compare the effects of topical nonsteroidal anti-inflammatory drugs on pupil dilation maintenance during phacoemulsification cataract surgery and quantify the relationships between pupil size change and nuclear hardness .


This prospective randomized clinical observation study was single centered and double-masked .


We studied 239 cases undergoing uneventful phacoemulsification cataract surgery in the absence of significant ocular comorbidity .


Cases were randomly assigned to 1 of 6 groups receiving the following treatments : ( 1 ) diclofenac ( 0.1 % ) ; ( 2 ) pranoprofen ( 0.1 % ) ; ( 3 ) control , physiological normal saline solution ; ( 4 ) diclofenac ( 0.1 % ) and epinephrine ; ( 5 ) pranoprofen ( 0.1 % ) and epinephrine ; ( 6 ) control , physiological normal saline and epinephrine solutions .


Pupil diameter was measured at 3 intervals of cataract surgery : before the first incision , at the end of nucleus fragmentation , and at the end of cortex irrigation/aspiration .


Compared with patients who were not treated , there was a significant difference in maintaining pupil dilation throughout the operation when the patients were treated with either diclofenac or pranoprofen , P < 0.001 and P < 0.03 , respectively .


From the first incision to postnucleus fragmentation , the change in pupil size in both diclofenac and control groups was significantly associated with the hardness of the crystalline lens , P = 0.001 and P = 0.012 , respectively .


At the end of irrigation/aspiration , the change in pupil size in only the control groups was significantly associated with the hardness of the crystalline lens , P = 0.022 .


Diclofenac treatment was most effective at inhibiting pupil miosis when the hardness of the nucleus was grade 3 , P = 0.009 .


Pupil miosis was not related to the hardness of the nucleus when the patients were treated with epinephrine .


Both diclofenac and pranoprofen treatment inhibit surgical-induced miosis .


There is a negative correlation between the hardness of the crystalline lens and pupil diameter maintenance at the early stage of phacoemulsification .


To assess whether the administration of symbiotic preparations in patients with multi-organ failure ( MOF ) diminishes the evolution of the failure , the inflammatory response generated , the colonization pattern and the Intensive Care Unit ( ICU ) infectious illness .


Randomized and controlled trial .


All patients with MOF were included .


Neutropenia and acute pancreatitis patients were excluded .


A symbiotic ( Simbiotic Drink ) was administered via enteral feeding during the first 7 days .


Variables of interest were : Sequential Organ Failure Assessment ( SOFA ) score evolution , systemic concentrations of lactate , fibrinogen and D-dimer ; skin and mucosa colonization and infectious disease register .


Eighty-nine patients were included ; 46 in the symbiotic group ( SG ) and 43 in the control group ( CG ) .


There were 68.5 % males , with a median age of 69 years .


There were no significant differences in the patients ' fundamental characteristics ( medical history , age , reason for admission , severity scores ) , nor in the length of ICU stay or in mortality .


Comparing the SG with the CG , there were lower lactate levels on the second day , more fibrinogen levels on the days 5 and 7 , and lower D-dimer levels on the day 7 .


Eight hundred and ninety-five cultures were performed for colonization assessment , with isolation of 528 microorganisms .


No differences in microbiological resistance were found ; there were more colonization in the SG by Candida in mucous membranes after the third day ; this situation resolved after stopping symbiotic administration .


Twenty-two patients suffered an infectious disease in ICU , 14 in SG ( 42.4 % ) and 19 in CG ( 57.6 % ) .


Although no differences were found in the microbiological pattern , there was a predominance of Candida spp .


over other microorganisms ( 4 vs. 0 cases ) .


The symbiotic preparation Simbiotic Drink , administered in MOF , results in differences to improve the early lactate levels and late fibrinogen/D-dimer levels as well as mucosa colonization by Candida .


There were no differences in the ICU evolution .


Whole-grain foods have been reported to affect serum levels of inflammatory cytokines .


However , we are aware of no study examining the effect of whole-grain intake on inflammatory biomarkers among children .


The present study aimed to determine the effect of whole-grain intake on serum levels of inflammatory biomarkers in overweight or obese children .


In this randomized crossover clinical trial , 44 overweight or obese girls aged 8-15 years participated .


After a 2-week run-in period , subjects were randomly assigned to either whole-grain or control groups .


Subjects in the whole-grain group were given a list of whole-grain foods and were asked to obtain half of their needed servings of grains from whole-grain foods each day for 6 weeks .


Individuals in the control group were also given a list of whole-grain foods and were asked not to consume any of these foods during the intervention phase of the study .


A 4-week washout period was applied following which subjects were crossed over to the alternate arm for an additional 6 weeks .


Fasting blood samples were taken before and after each phase of the study to quantify markers of systemic inflammation .


Mean age , weight , and BMI of study participants were 11.2 1.49 years , 51.2 10.2 kg , and 23.5 2.5 kg/m ( 2 ) , respectively .


No significant effect of whole-grain intake on weight and BMI was seen compared with the control group .


We found a significant effect of whole-grain intake on serum levels of high-sensitive C-reactive protein ( -21.8 versus +12.1 % , p = 0.03 ) , soluble intercellular adhesion molecule-1 ( -28.4 versus +6.3 % , p = 0.02 ) , serum amyloid A ( -17.4 versus +9.9 % , p = 0.02 ) , and leptin ( -9.7 versus +39.2 % , p = 0.02 ) after 6 weeks .


A trend toward the significant effect of whole-grain intake on serum levels of soluble vascular cell adhesion molecule-1 ( -36.2 % versus -7.8 % , p = 0.07 ) was also observed .


This study provides evidence supporting the beneficial effects of whole-grain foods on biomarkers of systemic inflammation in obese children .


This study addresses methods for training respirator users , particularly when occupational health professionals are not immediately available .


A randomized trial compared three training methods-printed brochure , video , and computer-based training-for two respirator types ( filtering facepiece and a dual-cartridge half facemask ) .


Quantitative fit testing ( PortaCount ) measured the effectiveness of training .


The study included 226 subjects .


For both respirator types , video was significantly superior to either print or computer-based training methods .


Conclusions were consistent , whether determined by average fit factor ( analysis of variance ) , log-transformed fit factors , or the number of users in the lowest quartile of achieved fit .


Video training for proper respirator use can be effective when direct training from an occupational health professional is unavailable .


These methods are particularly relevant to `` rapid rollout '' situations , such as natural disasters , epidemics , or bioterrorism concerns .


Widening socioeconomic disparities in mortality in the United States are largely explained by slower declines in tobacco use among smokers of low socioeconomic status ( SES ) than among those of higher SES , which points to the need for targeted tobacco cessation interventions .


Documentation of smoking status in electronic health records ( EHRs ) provides the tools for health systems to proactively offer tobacco treatment to socioeconomically disadvantaged smokers .


To evaluate a proactive tobacco cessation strategy that addresses sociocontextual mediators of tobacco use for low-SES smokers .


This prospective , randomized clinical trial included low-SES adult smokers who described their race and/or ethnicity as black , Hispanic , or white and received primary care at 1 of 13 practices in the greater Boston area ( intervention group , n = 399 ; control group , n = 308 ) .


We analyzed EHRs to identify potentially eligible participants and then used interactive voice response ( IVR ) techniques to reach out to them .


Consenting patients were randomized to either receive usual care from their own health care team or enter an intervention program that included ( 1 ) telephone-based motivational counseling , ( 2 ) free nicotine replacement therapy ( NRT ) for 6 weeks , ( 3 ) access to community-based referrals to address sociocontextual mediators of tobacco use , and ( 4 ) integration of all these components into their normal health care through the EHR system .


Self-reported past-7-day tobacco abstinence 9 months after randomization ( `` quitting '' ) , assessed by automated caller or blinded study staff .


The intervention group had a higher quit rate than the usual care group ( 17.8 % vs 8.1 % ; odds ratio , 2.5 ; 95 % CI , 1.5-4 .0 ; number needed to treat , 10 ) .


We examined whether use of intervention components was associated with quitting among individuals in the intervention group : individuals who participated in the telephone counseling were more likely to quit than those who did not ( 21.2 % vs 10.4 % ; P < .001 ) .


There was no difference in quitting by use of NRT .


Quitting did not differ by a request for a community referral , but individuals who used their referral were more likely to quit than those who did not ( 43.6 % vs 15.3 % ; P < .001 ) .


Proactive , IVR-facilitated outreach enables engagement with low-SES smokers .


Providing counseling , NRT , and access to community-based resources to address sociocontextual mediators among smokers reached in this setting is effective .


clinicaltrials.gov Identifier : NCT01156610 .


Sequential therapy is one of the recent answers given to the problem of increasing antibiotic resistance and decreasing eradication rates of Helicobacter pylori infection .


The aim of this study is to compare the ornidazole-based sequentialtherapy with the standard triple therapy in Helicobacter pylori eradication .


Children aged 4-18 years diagnosed with Helicobacter pylori infection based on histology and at least one of 13 C urea breath test and rapid urease test positivity were included in the study .


Children were randomized to standard triple therapy with amoxicillin , clarithromycin , and lansoprazole for 14 days and sequential therapy with amoxicillin and lansoprazole for the first 5 days and clarithromycin , ornidazole and lansoprazole for another 5 days in 2:3 randomization .


At the end of the treatment , families were contacted by phone , and side effects of and the compliance to the treatment were noted .


Patients were requested to do 13 C urea breath test 6-8 weeks after the treatment .


Sixty-one children were included for the final analysis .


Per-protocol eradication rates were 48.6 % for sequential therapy group and 54.2 % for standard triple therapy group .


Intention to treat eradication rates were 40.9 % and 46.0 % , respectively .


There were no differences between eradication rates in the two study groups .


Side effect rates were also similar between the two groups .


Ornidazole-based sequential therapy did not show any superiority compared to the standard triple treatment in children with Helicobacter pylori infection .


The purpose of this study was to compare illness-related anxiety among participants in the Rituximab Extended Schedule or Retreatment Trial ( RESORT ) randomly assigned to maintenance rituximab ( MR ) versus rituximab re-treatment ( RR ) .


A secondary objective was to examine whether the superiority of MR versus RR on anxiety depended on illness-related coping style .


Patients ( N = 253 ) completed patient-reported outcome ( PRO ) measures at random assignment to MR or RR ( baseline ) ; at 3 , 6 , 12 , 24 , 36 , and 48 months after random assignment ; and at rituximab failure .


PRO measures assessed illness-related anxiety and coping style , and secondary end points including general anxiety , worry and interference with emotional well-being , depression , and health-related quality of life ( HRQoL ) .


Patients were classified as using an active or avoidant illness-related coping style .


Independent sample t tests and linear mixed-effects models were used to identify treatment arm differences on PRO end points and differences based on coping style .


Illness-related anxiety was comparable between treatment arms at all time points ( P > .05 ) , regardless of coping style ( active or avoidant ) .


Illness-related anxiety and general anxiety significantly decreased over time on both arms .


HRQoL scores were relatively stable and did not change significantly from baseline for both arms .


An avoidant coping style was associated with significantly higher anxiety ( 18 % and 13 % exceeded clinical cutoff points at baseline and 6 months , respectively ) and poorer HRQoL compared with an active coping style ( P < .001 ) , regardless of treatment arm assignment .


Surveillance until RR at progression was not associated with increased anxiety compared with MR , regardless of coping style .


Avoidant coping was associated with higher anxiety and poorer HRQoL .


A two-year study assessed the benefit of an enhanced oral health promotion program combined with a closely supervised tooth brushing program in schools , using toothpaste containing 1,450 ppm F - and 1.5 % arginine , on oral health and dental caries .


15 southern Thailand schools and 3,706 pre-school children were recruited : 8 schools with 1,766 children as controls ; 7 schools with 1,940 children in the intervention groups .


Of the intervention schools five were classified as cooperative school and two as non-cooperative schools , based on the criteria of 80 % participation in the prescribed tooth brushing activities .


The DMFT and DMFS increments ( `` enamel and dentine '' ) were 1.19 and 1.91 for the control group and 1.04 and 1.59 for the intervention groups .


These represent 12.6 % and 16.8 % reductions in caries respectively .


The DMFT and DMFS increments ( `` dentine threshold '' ) were 0.26 and 0.44 for the control group and 0.19 and 0.29 for the intervention group , representing 26.9 % , and 34.1 % reductions in caries incidence respectively .


For the more cooperative schools the benefits were greater : up to a 40.9 % reduction in caries for DMFS ( `` dentine threshold '' ) .


At the 24 month examination there were significant improvements in dental plaque scores with greater improvements seen in the intervention group , greater still in the cooperative schools .


This study documents the positive effect from use of fluoridated toothpaste ( 1,450 ppm F - and 1.5 % arginine ) administered by schoolteachers and undertaken via an enhanced school oral health program .


Optimising oral health interventions for young children in Thai schools may have a significant impact on caries incidence resulting in reductions of up to 34 % reductions in caries for all schools included in the study and up to 41 % for the most cooperative .


Activation of the vascular endothelial growth factor receptor ( VEGFR ) and the oncogenic Src pathway has been implicated in the development of castration-resistant prostate cancer ( CRPC ) in preclinical models .


Cediranib and dasatinib are multi-kinase inhibitors targeting VEGFR and Src respectively .


Phase II studies of cediranib and dasatinib in CRPC have shown single agent activity .


Docetaxel-pretreated CRPC patients were randomized to arm A : cediranib alone ( 20 mg/day ) versus arm B : cediranib ( 20 mg/day ) plus dasatinib ( 100 mg/day ) given orally on 4-week cycles .


Primary endpoint was 12-week progression-free survival ( PFS ) as per the Prostate Cancer Clinical Trials Working Group ( PCWG2 ) .


Patient reported outcomes were evaluated using Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) and Present Pain Intensity ( PPI ) scales .


Correlative studies of bone turnover markers ( BTM ) , including bone alkaline phosphate ( BAP ) and serum beta-C telopeptide ( B-CTx ) were serially assayed .


Results A total of 22 patients , 11 per arm , were enrolled .


Baseline demographics were similar in both arms .


Median number of cycles = 4 in arm A ( range 1-12 ) and 2 in arm B ( range 1-9 ) .


Twelve-week PFS was 73 % in arm A versus 18 % in arm B ( p = 0.03 ) .


Median PFS in months ( arm A versus B ) was : 5.2 versus 2.6 ( 95 % CI : 1.9-6 .5 versus 1.4-not reached ) .


Most common grade 3 toxicities were hypertension , anemia and thrombocytopenia in arm A and hypertension , diarrhea and fatigue in arm B.


One treatment-related death ( retroperitoneal hemorrhage ) was seen in arm A. FACT-P and PPI scores did not significantly change in either arm .


No correlation between BTM and PFS was seen in either arm .


Although limited by small numbers , this randomized study showed that the combination of VEGFR and Src targeted therapy did not result in improved efficacy and may be associated with a worse outcome than VEGFR targeted therapy alone in patients with CRPC .


ClinicalTrials.gov number : NCT01260688 .


Colonoscopy is associated with pain and discomfort in the majority of patients when performed without sedation .


We performed a prospective and randomized study to compare warm water instillation and standard air-insufflation colonoscopy techniques without any sedation .


The data of 122 patients ( 64 female and 58 male ) were statistically analyzed .


Patients were randomized into two groups by using computer generated list .


In group A , standard colonoscopy with air insufflation was performed .


In group B colonoscopy was performed by warm water infusion into the bowel .


No analgesic , antispasmodic or sedative medications were used .


After colonoscopy , the level of pain during colonoscopy experienced by the patient was measured using the visual analog scale ( VAS ) .


There were no statistically significant differences in gender and average age between the two groups of patients .


Cecal intubation was successful in all patients ( 100 % ) .


All colonoscopies were performed without complications .


Patients who had colonoscopy with water immersion had a significantly lower level of pain on the VAS ( 4.09 vs 5.06 ) , p = 0.041 .


We confirmed the advantages of warm water instillation for colonoscope insertion in reducing pain without compromising the time to reach the cecum , success of cecum intubation or patient safety .


To evaluate safety , ocular tolerability and pharmacokinetics of 0.5 % and 2.5 % cis-urocanic acid ( cis-UCA ) eye drops .


In this phase I , double-blinded , placebo-controlled trial , 37 healthy volunteers were randomized to three treatment arms : 0.5 % cis-UCA ( 12 subjects ) , 2.5 % cis-UCA ( 12 subjects ) and placebo eye drops ( 13 subjects ) .


In the first part , the subjects were dosed topically on a randomized eye with one drop three times at 7 1 hr intervals during 1 day .


In the second part , the subjects self-administered three daily drops at 7 1 hr intervals on both eyes for 14 days .


Physical examination of the eyes was performed seven times during the study .


Tolerability of cis-UCA was assessed by ocular comfort rating questionnaire .


Pharmacokinetic blood and urine samples were analysed under good laboratory practice ( GLP ) .


All subjects completed both parts of the study .


There were no significant adverse events ( AEs ) .


The most common treatment-related ocular AE was eye irritation ( 62.2 % of subjects ) .


Cis-UCA concentrations in plasma remained below the limit of quantification ( 0.195 g/ml ) in all but two subjects .


The fraction of the administered drug excreted into urine over the total collection period ranged from 3.2 % to 61.6 % of the last dose and from 1.1 % to 20.5 % of the daily dose .


Topical ocular administration of cis-UCA solution is safe and apart from mild - and short-lasting eye irritation after administration well tolerated in healthy adult subjects .


Topical ocular dosing leads to transient systemic exposure to cis-UCA that does not cause systemic AEs .


Diode lasers are becoming popular in gingival treatment following orthodontic treatments .


Despite their merit and clinical implications , postoperative pain and bleeding after surgery with diode lasers are not assessed except in few controversial studies .


This controlled clinical trial was conducted on 30 healthy orthodontic patients aged 17-29 years , needing esthetic-only gingivectomy in the anterior maxilla .


The patients were randomly divided into two groups of 15 each : experimental ( laser-assisted surgery ) and control ( traditional surgery using scalpels ) .


The bleeding rate following the surgery was assessed using the bleeding criteria established by the World Health Organization .


The postsurgical pain level was recorded using visual analog scales immediately after the surgery and in patients who consumed analgesics , also 2 h after the analgesic consumption .


The data were analyzed using the independent-samples t , Mann-Whitney U , and chi-square tests ( = 0.05 ) .


The average bleeding rates were 1.15 and 0.36 in the conventional and laser groups , respectively ( Mann-Whitney U P < 0.05 ) .


Experimental patients had no postsurgical pain ( VAS1 and VAS2 = 0 ) .


In the control group , the average VAS1 pain was 5.2 out of 10 .


The difference between VAS1 values in the control/experimental groups was significant ( Mann-Whitney U P < 0.001 ) .


940-nm diode laser seems promising in reducing postoperative bleeding and pain of patients needing cosmetic smile lift surgeries .


Theory-based process evaluations conducted alongside randomized controlled trials provide the opportunity to investigate hypothesized mechanisms of action of interventions , helping to build a cumulative knowledge base and to inform the interpretation of individual trial outcomes .


Our objective was to identify the underlying causal mechanisms in a cluster randomized trial of the effectiveness of printed educational materials ( PEMs ) to increase referral for diabetic retinopathy screening .


We hypothesized that the PEMs would increase physicians ' intention to refer patients for retinal screening by strengthening their attitude and subjective norm , but not their perceived behavioral control .


Design : A theory based process evaluation alongside the Ontario Printed Educational Material ( OPEM ) cluster randomized trial .


Postal surveys based on the Theory of Planned Behavior were sent to a random sample of trial participants two months before and six months after they received the intervention .


Setting : Family physicians in Ontario , Canada .


Participants : 1,512 family physicians ( 252 per intervention group ) from the OPEM trial were invited to participate , and 31.3 % ( 473/1512 ) responded at time one and time two .


The final sample comprised 437 family physicians fully completing questionnaires at both time points .


Main Outcome Measures : Primary : behavioral intention related to referring patient for retinopathy screening ; secondary : attitude , subjective norm , perceived behavioral control .


At baseline , family physicians reported positive intention , attitude , subjective norm , and perceived behavioral control to advise patients about retinopathy screening suggesting limited opportunities for improvement in these constructs .


There were no significant differences on intention , attitude , subjective norm , and perceived behavioral control following the intervention .


Respondents also reported additional physician - and patient-related factors perceived to influence whether patients received retinopathy screening .


Lack of change in the primary and secondary theory-based outcomes provides an explanation for the lack of observed effect of the main OPEM trial .


High baseline levels of intention to advise patients to attend retinopathy screening suggest that post-intentional and other factors may explain gaps in care .


Process evaluations based on behavioral theory can provide replicable and generalizable insights to aid interpretation of randomized controlled trials of complex interventions to change health professional behavior .


ISRCTN72772651 .


To determine whether cranberry capsules prevent urinary tract infection ( UTI ) in long-term care facility ( LTCF ) residents .


Double-blind randomized placebo-controlled multicenter trial .


Long-term care facilities ( LTCFs ) .


LTCF residents ( N = 928 ; 703 women , median age 84 ) .


Cranberry and placebo capsules were taken twice daily for 12 months .


Participants were stratified according to UTI risk ( risk factors included long-term catheterization , diabetes mellitus , 1 UTI in preceding year ) .


Main outcomes were incidence of UTI according to a clinical definition and a strict definition .


In participants with high UTI risk at baseline ( n = 516 ) , the incidence of clinically defined UTI was lower with cranberry capsules than with placebo ( 62.8 vs 84.8 per 100 person-years at risk , P = .04 ) ; the treatment effect was 0.74 ( 95 % confidence interval ( CI ) = 0.57-0 .97 ) .


For the strict definition , the treatment effect was 1.02 ( 95 % CI = 0.68-1 .55 ) .


No difference in UTI incidence between cranberry and placebo was found in participants with low UTI risk ( n = 412 ) .


In LTCF residents with high UTI risk at baseline , taking cranberry capsules twice daily reduces the incidence of clinically defined UTI , although it does not reduce the incidence of strictly defined UTI .


No difference in incidence of UTI was found in residents with low UTI risk .


Combining bevacizumab with first-line or second-line chemotherapy improves progression-free survival in HER2-negative locally recurrent or metastatic breast cancer .


We assessed the efficacy and safety of further bevacizumab therapy in patients with locally recurrent or metastatic breast cancer whose disease had progressed after treatment with bevacizumab plus chemotherapy .


In this open-label , randomised , phase 3 trial , we recruited patients who had HER2-negative locally recurrent or metastatic breast cancer that had progressed after receiving 12 weeks or more of first-line bevacizumab plus chemotherapy from 118 centres in 12 countries .


Patients were randomly assigned ( 1:1 ) by use of a central interactive voice response system using a block randomisation schedule ( block size four ) stratified by hormone receptor status , first-line progression-free survival , selected chemotherapy , and lactate dehydrogenase concentration , to receive second-line single-agent chemotherapy either alone or with bevacizumab ( 15 mg/kg every 3 weeks or 10 mg/kg every 2 weeks ) .


Second-line therapy was continued until disease progression , unacceptable toxicity , or consent withdrawal .


At progression , patients randomly assigned to chemotherapy alone received third-line chemotherapy without bevacizumab ; those randomly assigned to bevacizumab continued bevacizumab with third-line chemotherapy .


The primary endpoint was progression-free survival from randomisation to second-line progression or death in the intention-to-treat population .


This trial is ongoing , and registered with ClinicalTrials.gov , number NCT01250379 .


Between Feb 17 , 2011 , and April 3 , 2013 , 494 patients were randomly assigned to treatment ( 247 in each group ) .


The median duration of follow-up at the time of this prespecified primary progression-free survival analysis was 159 months ( IQR 91-217 ) in the chemotherapy-alone group and 161 months ( 106-227 ) in the combination group .


Progression-free survival was significantly longer for those patients treated with bevacizumab plus chemotherapy than for those with chemotherapy alone ( median : 63 months [ 95 % CI 54-72 ] vs 42 months [ 39-47 ] , respectively , stratified hazard ratio [ HR ] 075 [ 95 % CI 061-093 ] , two-sided stratified log-rank p = 00068 ) .


The most common grade 3 or more adverse events were hypertension ( 33 [ 13 % ] of 245 patients receiving bevacizumab plus chemotherapy vs 17 [ 7 % ] of 238 patients receiving chemotherapy alone ) , neutropenia ( 29 [ 12 % ] vs 20 [ 8 % ] ) , and hand-foot syndrome ( 27 [ 11 % ] vs 25 [ 11 % ] ) .


Grade 3 proteinuria occurred in 17 ( 7 % ) of 245 patients receiving combination therapy and one ( < 1 % ) of 238 patients receiving chemotherapy alone .


Serious adverse events were reported in 61 ( 25 % ) of 245 patients receiving bevacizumab plus chemotherapy versus 44 ( 18 % ) of 238 patients receiving chemotherapy alone .


These results suggest that continued VEGF inhibition with further bevacizumab is a valid treatment option for patients with locally recurrent or metastatic HER2-negative breast cancer whose disease was stabilised or responded to first-line bevacizumab with chemotherapy .


F Hoffmann-La Roche .


Evaluate tools to help pregnant women with prior cesareans make informed decisions about having trials of labor .


Randomized comparative trial .


A research assistant with a laptop met the women in quiet locations at clinics and at health fairs .


Pregnant women ( N = 131 ) who had one prior cesarean and were eligible for vaginal birth after cesarean ( VBAC ) participated one time between 2005 and 2007 .


Women were randomized to receive either an evidence-based , interactive decision aid or two evidence-based educational brochures about cesarean delivery and VBAC .


Effect on the decision-making process was assessed before and after the interventions .


Compared to baseline , women in both groups felt more informed ( F = 23.8 , p < .001 ) , were more clear about their birth priorities ( F = 9.7 , p = .002 ) , felt more supported ( F = 9.8 , p = .002 , and overall reported less conflict ( F = 18.1 , p < 0.001 ) after receiving either intervention .


Women in their third trimesters reported greater clarity around birth priorities after using the interactive decision aid than women given brochures ( F = 9.8 , p = .003 ) .


Although both decision tools significantly reduced conflict around the birth decision compared to baseline , more work is needed to understand which format , the interactive decision aid or paper brochures , are more effective early and late in pregnancy .


Econazole nitrate is a broad-spectrum topical antifungal with activity against a variety of dermatophytes and yeasts .


A new topical dosage form , econazole nitrate topical foam 1 % , utilizing patented Proderm Technology has been developed for treatment of interdigital tinea pedis .


To evaluate econazole nitrate foam 1 % versus foam vehicle for treatment of interdigital tinea pedis .


Two randomized , double-blind , parallel-group , vehicle-controlled , multicenter studies enrolled males and females 12 years old with a clinical diagnosis of interdigital tinea pedis and baseline fungal culture positive for a dermatophyte .


Subjects applied econazole nitrate foam 1 % ( n = 246 ) or foam vehicle ( n = 249 ) once daily for 4 weeks .


The primary endpoint was proportion of subjects achieving a complete cure ( negative KOH , negative fungal culture , complete resolution of all signs and symptoms ) at 2 weeks post-treatment ( Day 43 ) .


Secondary endpoints included mycologic cure ( negative KOH and negative culture ) and effective treatment ( mycologic cure + no or mild erythema and/or scaling and all other signs and symptoms absent ) .


The complete cure rate at Day 43 was 24.3 % for econazole nitrate foam 1 % vs 3.6 % for foam vehicle .


In addition , higher rates of mycologic cure ( 67.6 % vs 16.9 % ) and effective treatment ( 48.6 % vs 10.8 % ) were observed with econazole nitrate foam 1 % versus the foam vehicle .


There were few adverse events and only nasopharyngitis and headache were experienced by > 1 % of subjects .


No serious adverse events were reported for econazole nitrate foam 1 % .


Econazole nitrate foam 1 % exhibited superiority over foam vehicle for the primary and secondary endpoints with a high mycologic cure rate for all pathogens evaluated .


Econazole nitrate foam 1 % was safe and well tolerated with a safety profile comparable with the foam vehicle .


Econazole nitrate foam 1 % presents a novel alternative for the management of tinea pedis .


Thyroid dysfunction is associated with impaired cognitive development .


Perchlorate decreases thyroidal iodine uptake , potentially reducing thyroid hormone production .


It is unclear whether perchlorate exposure in early life affects neurodevelopment .


Historical cohort analysis .


From 2002 to 2006 , 21,846 women at gestational age < 16 weeks recruited from antenatal clinics in Cardiff , UK and Turin , Italy were enrolled in the Controlled Antenatal Thyroid Screening Study ( CATS ) .


We undertook a retrospective analysis of 487 mother-child pairs in mothers who were hypothyroid/hypothyroxinemic during pregnancy and analyzed whether first trimester maternal perchlorate levels in the highest 10 % of the study population were associated with increased odds of offspring IQ being in the lowest 10 % at 3 years of age .


Maternal urinary perchlorate , offspring IQ .


Urine perchlorate was detectable in all women ( median 2.58 g/L ) ; iodine levels were low ( median 72 g/L ) .


Maternal perchlorate levels in the highest 10 % of the population increased the odds of offspring IQ being in the lowest 10 % OR = 3.14 ( 95 % CI 1.38 , 7.13 ) P = .006 with a greater negative impact observed on verbal OR = 3.14 ( 95 % CI 1.42 , 6.90 ) P = .005 than performance IQ .


Maternal levothyroxine therapy did not reduce the negative impact of perchlorate on offspring IQ .


This is the first study using individual-level patient data to study maternal perchlorate exposure and offspring neurodevelopment and suggests that high-end maternal perchlorate levels in hypothyroid/hypothyroxinemic pregnant women have an adverse effect on offspring cognitive development , not affected by maternal levothyroxine therapy .


These results require replication in additional studies , including in the euthyroid population .


Varenicline has been shown to significantly reduce craving and several aspects of smoking reinforcement in clinical trials , compared with placebo .


This is the first report describing the concentration-effect relationship of varenicline on relief of craving .


The pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of a single 2mg dose of varenicline were investigated in 40 smokers in a randomized , crossover study comparing the effect of varenicline with placebo on ameliorating abstinence-and cue-induced craving and withdrawal symptoms .


Subjects were asked to complete self-reported questionnaires ( Smoking Urges Scale and Minnesota Nicotine Withdrawal Scale [ MNWS ] ) and blood samples were simultaneously collected for measurement of varenicline concentrations .


Only the data from the 4-hr postdose abstinence period ( just prior to the cue session ) were analyzed .


Data were described by a 2-compartment PK model and a linear PD model with first-order onset/offset rate constants describing the placebo response `` kinetics . ''


Response was described as the net effect of the baseline , placebo , and drug responses .


Varenicline significantly decreased mean craving score when compared with placebo and the magnitude of this response was related to varenicline concentration .


The time-course and magnitude of both placebo and varenicline craving response were characterized by a large degree of unexplained variability .


Simulations were used to illustrate the expected craving response over time and its associated random variability after chronic dosing .


Craving reduction is associated with increased varenicline concentrations .


The relatively rapid onset of this effect within 4 hr postdose suggests that , smokers may experience some craving relief after acute administration of varenicline .


This study aims to evaluate the effects on physical activity ( PA ) and eating behavior ( EB ) of a tailored behavioral medicine intervention and first-time continuous positive airway pressure ( CPAP ) treatment compared with first-time CPAP treatment and advice in patients with obstructive sleep apnea syndrome ( OSAS ) and overweight .


Seventy-three patients ( meanSD , 5512years ) with overweight ( body mass index ( BMI ) , 34.54.8 ) and moderate or severe OSAS ( Apnea-Hypopnea Index , 41.720.9 ) scheduled for CPAP prescription were randomized to a control group ( CPAP and advice on the association between weight and OSAS ) or an experimental group ( CPAP and a 6-month behavioral medicine intervention targeting PA and EB ) .


At baseline and after 6months , eating behavior ( food frequency screening and Dutch Eating Behavior Questionnaire ) , weight , BMI , and waist circumference were assessed at one point , while PA and sedentary time were measured with accelerometry during 4days .


The experimental group reduced 2.1 kg ( 4.6 ) in weight and 3cm ( 4.9 ) in waist circumference , significantly more than the control group .


At 6months , the experimental group ate more fruit and fish/shellfish than the control group .


Low and moderate to vigorous PA did not change over time either within or between groups .


Regarding BMI , steps , and sedentary time , there were within-group differences but no differences between groups .


The behavioral medicine intervention did not change physical activity but facilitated changes in EB in patients with OSAS and overweight .


The amount of weight loss and reduction in waist circumference favored the participants receiving this treatment .


Since the strategies for achieving behavioral changes were tailored according to the individual 's goals and personal functional behavioral analyses and progressed slowly in a graded manner , it might require higher PA quotas or a period longer than 6months to reveal a behavioral change of larger proportions .


Preprocedural 3-dimensional CT imaging of the aortic annular plane plays a critical role for transcatheter aortic valve replacement ( TAVR ) planning ; however , manual reconstructions are complex .


Automated analysis software may improve reproducibility and agreement between readers but is incompletely validated .


In 110 TAVR patients ( mean age , 81 years ; 37 % female ) undergoing preprocedural multidetector CT , automated reconstruction of the aortic annular plane and planimetry of the annulus was performed with a prototype of now commercially available software ( syngo.CT Cardiac Function-Valve Pilot ; Siemens Healthcare , Erlangen , Germany ) .


Fully automated , semiautomated , and manual annulus measurements were compared .


Intrareader and inter-reader agreement , intermodality agreement , and interchangeability were analyzed .


Finally , the impact of these measurements on recommended valve size was evaluated .


Semiautomated analysis required major correction in 5 patients ( 4.5 % ) .


In the remaining 95.5 % , only minor correction was performed .


Mean manual annulus area was significantly smaller than fully automated results ( P < .001 for both readers ) but similar to semiautomated measurements ( 5.0 vs 5.4 vs 4.9 cm ( 2 ) , respectively ) .


The frequency of concordant recommendations for valve size increased if manual analysis was replaced with the semiautomated method ( 60 % agreement was improved to 82.4 % ; 95 % confidence interval for the difference [ 69.1 % -83.4 % ] ) .


Semiautomated aortic annulus analysis , with minor correction by the user , provides reliable results in the context of TAVR annulus evaluation .


Chronic low-back pain ( cLBP ) is a common condition throughout the world , and acupuncture is widely sought for treatment .


As clinical evidence for the benefits of acupuncture grows , acupuncture for cLBP is receiving increased recognition and acceptance by both patients and professionals .


Time method acupuncture has been previously researched with respect to chronic gastritis .


For individuals with cLBP in the current study , the research team examined the efficacy of adding confluent acupoints , related to the daytime period in time method acupuncture , to regular acupuncture and also evaluated the persistence of the benefits of such acupuncture in comparison with regular acupuncture .


The study was a randomized , controlled trial ( RCT ) .


The setting was an outpatient clinic of the Dongzhimen Hospital in Beijing , China .


Participants were Chinese men and women with cLBP .


Sixty participants were randomly divided into 2 groups to receive acupuncture .


The control group received a treatment that followed a routine acupuncture ( RA ) protocol , while the intervention group received a treatment that followed an RA protocol plus acupuncture in confluent points related to time ( TA ) .


The research team measured the change in participants ' scores using the visual analogue scale ( VAS ) , the number of therapy sessions needed , the number of days that participants were absent from work during the treatment period and at 12 wk posttreatment , and the number of pain relapses between the end of treatment and the 4 - and 12-wk follow-ups .


VAS scores decreased from 69.6 7.9 to 11.8 4.9 in the intervention group compared with a decrease from 69.2 8.0 to 15.7 10.0 in the control group ( P = .001 ) .


The intervention group received fewer therapy sessions ( 8.1 2.0 ) than did the control group ( 10.1 2.0 , P < .001 ) .


Compared with the controls , the intervention group showed fewer days absent from work ( 0.5 vs 1.4 ; P = .03 ) and fewer pain relapses ( 4.0 vs 7.0 ; P = .04 ) at the 12-wk follow-up .


In the 2 groups combined , VAS decreased from 69.4 7.9 before the first session of acupuncture to 13.8 8.0 after the last session ( P < .001 ) , and the number of therapy sessions needed for pain relief was 9.1 2.2 .


Accompanying routine acupuncture with time method acupuncture can enhance the efficacy of treatment and the persistence of its benefits in individuals with cLBP .


To evaluate the effect of a protocol of local anesthesia and epinephrine associated with sedo-analgesia on post-TVT-O pain in comparison with infiltration of saline and epinephrine .


Forty-two patients undergoing TVT-O were randomized into two groups to receive periurethral infiltration with epinephrine only ( group A , n = 21 ) or with epinephrine plus 1 % lidocaine hydrochloride ( group B , n = 21 ) .


Post-operative pain was assessed using a visual analog scale ( VAS ) from 0 ( absence of pain ) to 10 ( maximum pain possible ) , 1 , 6 , 12 and 24 h after the procedure .


The total amount of analgesia was recorded and the proportion of women reporting a pain VAS score 4 , 1 h after the procedure was calculated .


ANOVA for repeated measures and Bonferroni correction , the Student 's t test for independent samples , the Mann-Whitney U test , the Fisher exact test , or the ( 2 ) test for parametric was used .


Pain level was significantly lower in group B 1 ( p = 0.01 ) and 6 h ( p = 0.05 ) after surgery , but not 12 and 24 h after the procedure .


No significant difference was observed in the proportion of women requesting analgesia and in the total dosage of analgesics between the two groups .


A significant higher proportion of women in group A reported a pain VAS score higher than four 1 h after surgery in comparison with patients in group B.


This randomized study seems to indicate that systematic infiltration before TVT-O positioning with local anesthetic may reduce immediate post-operative pain .


Therapeutic hypothermia ( TH , 32-34C ) has been shown to improve neurological outcome in comatose survivors of out-of-hospital cardiac arrest ( OHCA ) with ventricular tachycardia or fibrillation .


Earlier initiation of TH may increase the beneficial effects .


Experimental studies have suggested that starting TH during cardiopulmonary resuscitation ( CPR ) may further enhance its neuroprotective effects .


The aim of this study was to evaluate whether intra-arrest TH ( IATH ) , initiated in the field with trans nasal evaporative cooling ( TNEC ) , would provide outcome benefits when compared to standard of care in patients being resuscitated from OHCA .


We describe the methodology of a multi-centre , randomized , controlled trial comparing IATH delivered through TNEC device ( Rhinochill , Benechill Inc. , San Diego , CA , USA ) during CPR to standard treatment , including TH initiated after hospital admission .


The primary outcome is neurological intact survival defined as cerebral performance category 1-2 at 90days among those patients who are admitted to the hospital .


Secondary outcomes include survival at 90days , proportion of patients achieving a return to spontaneous circulation ( ROSC ) , the proportion of patients admitted alive to the hospital and the proportion of patients achieving target temperature ( < 34C ) within the first 4hours since CA .


This ongoing trial will assess the impact of IATH with TNEC , which may be able to rapidly induce brain cooling and have fewer side effects than other methods , such as cold fluid infusion .


If this intervention is found to improve neurological outcome , its early use in the pre-hospital setting will be considered as an early neuro-protective strategy in OHCA .


NCT01400373 .


Body weight-supported treadmill training ( BWSTT ) has produced mixed results compared with other therapeutic techniques .


The purpose of this study was to determine whether an intensive intervention ( intensive mobility training ) including BWSTT provides superior gait , balance , and mobility outcomes compared with a similar intervention with overground gait training in place of BWSTT .


Forty-three individuals with chronic stroke ( mean [ SD ] age , 61.5 [ 13.5 ] years ; mean [ SD ] time since stroke , 3.3 [ 3.8 ] years ) , were randomized to a treatment ( BWSTT , n = 23 ) or control ( overground gait training , n = 20 ) group .


Treatment consisted of 1 hour of gait training ; 1 hour of balance activities ; and 1 hour of strength , range of motion , and coordination for 10 consecutive weekdays ( 30 hours ) .


Assessments ( step length differential , self-selected and fast walking speed , 6-minute walk test , Berg Balance Scale [ BBS ] , Dynamic Gait Index [ DGI ] , Activities-specific Balance Confidence [ ABC ] scale , single limb stance , Timed Up and Go [ TUG ] , Fugl-Meyer [ FM ] , and perceived recovery [ PR ] ) were conducted before , immediately after , and 3 months after intervention .


No significant differences ( = 0.05 ) were found between groups after training or at follow-up ; therefore , groups were combined for remaining analyses .


Significant differences ( = 0.05 ) were found pretest to posttest for fast walking speed , BBS , DGI , ABC , TUG , FM , and PR .


DGI , ABC , TUG , and PR results remained significant at follow-up .


Effect sizes were small to moderate in the direction of improvement .


Future studies should investigate the effectiveness of intensive interventions of durations greater than 10 days for improving gait , balance , and mobility in individuals with chronic stroke .


The aim of this study was to evaluate the clinical benefit of valacyclovir when performing full-mouth periodontal debridement in patients with advanced chronic periodontitis .


Fifty-nine patients with advanced chronic periodontitis were randomly assigned into control-treatment group ( n = 29 ) and intensive-treatment group ( n = 30 ) .


All patients were given instructions of basic oral hygiene and a standard cycle of supragingival mechanical scaling and polishing .


Patients in the intensive-treatment group received oral valacyclovir for 1 week , while patients in the control-treatment group received placebo .


Thereafter , patients in both groups underwent full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing within 48 hours .


Periodontal parameters were evaluated before treatment and 2 or 6 months after treatment .


The data was statistically analyzed using SPSS17 .0 software package .


No significant difference in clinical parameters was noted before treatment .


2 and 6 months after treatment , the mean percentage reduction of sites with BOP and PD4 mm were significantly higher in the intensive-treatment group than in the control-treatment group ( P < 0.05 ) .


Similarly , patients in the intensive-treatment group had higher mean PD reduction than those in the control-treatment group 2 months ( P < 0.05 ) and 6 months after therapy ( P < 0.05 ) .


However , the mean values of CAL reduction were slightly and not significantly higher in the intensive-treatment group than in the control-treatment group after therapy .


It may be concluded that valacyclovir significantly improves clinical results of full-mouth non-surgical periodontal debridement in advanced chronic periodontitis .


Heart rate was proposed as an emergent cardiovascular ( CV ) risk factor .


Previous studies have shown associations between increased heart rate and CV risk in various populations .


We aimed to evaluate the prognostic relevance of heart rate in a large contemporaneous medically optimized cohort of patients with stable chronic CV disease .


In a post hoc analysis of the ONTARGET/TRANSCEND trials , we evaluated associations between baseline and average heart rate in trial with CV risk in 31 , 531 patients followed for a median of 5 years .


The primary outcome , major vascular events ( MVE ) , was a composite of CV death , myocardial infarction ( MI ) , stroke , and congestive heart failure ( CHF ) .


Pre-specified secondary outcomes included all-cause death and the individual components of the primary outcome .


Associations between heart rate and outcomes were computed with heart rate as a continuous variable , baseline heart rate > 70 vs 70 bpm , and across heart rate quintiles , adjusting for other markers of risk , beta-blocker and non-dihydropyridine calcium channel blocker use .


For each 10 bpm increase in baseline and average heart rate , we observed a significant increase in risk of MVE , CV death , CHF and all-cause death .


There was a continuous relationship between MVE and baseline and , more importantly , average in-trial heart rate , with no observed threshold .


MVE , CV death , stroke , CHF , and all-cause death increased across heart rate quintiles .


There was no association between MI and HR .


Results were consistent in clinically relevant subgroups .


There were modest but significant improvements in C-statistic and in statistical measures of model calibration for models that included heart rate for MVE , CV death , CHF and all-cause death .


This large study examined and quantitated associations between heart rate and CV events in a contemporary medically optimized population with stable CV disease .


Resting and , in particular , in-trial average heart rate are independently associated with significant increases in CV events and all-cause death .


Lumbar laminectomy is a commonly performed procedure in neurosurgical and orthopedic practice .


Postoperative pain reliefhelps in early mobilization , initiation of physiotherapy , provides satisfaction to the patients and plays an important role in reducing the morbidity and mortality .


This prospective study investigated the simple technique of instillation of wound with bupivacaine and leaving a contact time of 60 seconds on postoperative pain following lumbar laminectomy .


32 ASA I and II patients scheduled for laminectomy were randomly allocated to receive either 20 ml of normal saline ( group I ) or 0.25 % of bupivacaine ( group II ) into the wound after securing hemostasis .


After a dwell time of 60sec the wound was closed in layers without mopping or suctioning .


After extubation , the pain scores were evaluated by visual analog scale at every 4 hrs .


for 24hrs and also the time for first demand of analgesia , number of analgesic demands and the total amount of analgesia consumed were noted by an independent observer .


The median duration of analgesia in group I was 8.8 [ 5-11 ] and in group II 13 [ 8.5-16 ] hrs .


with a p = 0.04 .


The number of demands and the amount of analgesia consumed was also statistically significant .


Wound instillation technique is simple , safe and effective in management of acute pain management after lumbar laminectomy and can be used as one among the multimodal armamentarium in pain management .


The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program ( MAGDA-DPP ) is a randomized controlled trial ( RCT ) that aims to assess the effectiveness of a structured diabetes prevention intervention for women who had gestational diabetes .


The original protocol was published in Trials ( http://www.trialsjournal.com/content/14/1/339 ) .


This update reports on an additional exclusion criterion and change in first eligibility screening to provide greater clarity .


The new exclusion criterion `` surgical or medical intervention to treat obesity '' has been added to the original protocol .


The risks of developing diabetes will be affected by any medical or surgical intervention as its impact on obesity will alter the outcomes being assessed by MAGDA-DPP .


The screening procedures have also been updated to reflect the current recruitment operation .


The first eligibility screening is now taking place either during or after pregnancy , depending on recruitment strategy .


Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066 .


To compare prostatic arterial embolization ( PAE ) and transurethral resection of the prostate ( TURP ) in the care of patients with benign prostatic hyperplasia ( BPH ) .


This prospective randomized clinical trial was approved by the institutional review board .


A total of 114 patients provided written informed consent and were randomly assigned to undergo PAE ( n = 57 ) or TURP ( n = 57 ) .


The groups were compared regarding relevant adverse events and complications .


Functional results -- including improvement of International Prostate Symptom Score ( IPSS ) , quality of life ( QOL ) , peak urinary flow , postvoiding residual urine volume , prostate-specific antigen ( PSA ) level , and prostate volume -- were assessed at 1 - , 3 - , 6 - , 12 - , and 24-month follow-up between January 20 , 2007 , and January 31 , 2012 .


Student t test , ( 2 ) test , Fisher exact test , and repeated measures analysis of variance were used , as appropriate .


Overall technical success rates for TURP and PAE were 100 % and 94.7 % , respectively ; the clinical failure rates were 3.9 % and 9.4 % , respectively .


The six functional results showed improvements after TURP and PAE at all follow-up time points when compared with preoperative values ( P = .001 ) .


However , the TURP group showed greater degrees of improvement in the IPSS , QOL , peak urinary flow , and postvoiding residual urine volume at 1 and 3 months , as well as greater reductions in the PSA level and prostate volume at all follow-up time points , when compared with the PAE group ( P < .05 ) .


The PAE group showed more overall adverse events and complications ( P = .029 ) , mostly related to acute urinary retention ( 25.9 % ) , postembolization syndrome ( 11.1 % ) , and treatment failures ( 5.3 % technical ; 9.4 % clinical ) .


Both procedures resulted in significant clinical improvements in the treatment of BPH .


However , the advantages of the PAE procedure must be weighed against the potential for technical and clinical failures in a minority of patients .


The aim of this trial was to compare the effects of resistance training versus passive physical therapy on quality of life ( QoL ) , fatigue , and emotional distress outcomes during radiation therapy in patients with spinal bone metastases under radiotherapy ( RT ) .


In this randomized trial , 60 patients were treated from September 2011 until March 2013 into one of the two groups : isometric resistance training or physical therapy with thirty patients in each group during RT. .


EORTC QLQ-BM22 , EORTC QLQ-FA13 , and FBK-R10 were assessed at baseline , three months , and six months after RT. .


Psychosocial aspects in resistance training group ( Arm A ) were significantly improved after three ( p = 0.001 ) and six months ( p = 0.010 ) .


Other rated items of the QLQ-BM22 painful site , and pain characteristics were without significant differences .


Functional interference showed a positive trend after six months ( p = 0.081 ) .


After six months , physical fatigue ( p = 0.013 ) , and interference with daily life ( p = 0.006 ) according to the QLQ-FA13 assessment improved in Arm A significantly .


Emotional distress was in Arm A lower after six months ( p = 0.016 ) .


The Cohen 's effect size confirmed the clinically significant improvement of these findings .


In this group of patients we were able to show that guided isometric resistance training of the paravertebral muscles can improve functional capacity , reduce fatigue and thereby enhance QoL over a 6-months period in patients with stable spinal metastases .


The results offer a rationale for future large controlled investigations to confirm these findings .


Clinical trial identifier NCT01409720 .


Isotretinoin-Lidose , the first new formulation of isotretinoin in 30 years , differs from previously approved isotretinoin formulations in that it is less dependent on the presence of fat in the gut for absorption .


Evaluate the safety profiles of isotretinoin-Lidose and food-dependent generic isotretinoin in the largest clinical study with isotretinoin-925 randomized patients from 49 study sites .


Determine if the efficacy of this new formulation is noninferior to an existing isotretinoin .


Multicenter , double-blind , randomized , parallel-group , noninferiority trial .


Study medication was taken with meals twice daily for 20 weeks .


Patients were followed for 4 weeks after the last dose .


Safety evaluations included recordings of adverse events , assessments for depression , anxiety , emergent psychotic symptoms , and suicidal ideation/behavior , as well as DEXA and X-ray evaluations and changes in bone age .


Two co-primary efficacy outcomes were measured to assess noninferiority : a ) change in total nodular facial and truncal lesion count at from baseline to week 20 and b ) percentage of patients who experienced at least 90 % reduction in nodular facial and truncal lesion count from baseline to week 20 .


Although isotretinoin-Lidose can be taken without meals , it was given with food because the absorption of both formulations in the study had to be similar to detect noninferiority .


The safety profile of the 2 formulations was comparable .


Criteria for noninferiority for both co-primary efficacy outcomes were met based on predetermined margins .


Safety and efficacy of isotretinoin-Lidose is similar and noninferior to food-dependent generic isotretinoin , respectively .


To optimize contrast media ( CM ) injection protocols by individually tailoring the dose to the patient 's body weight ( BW ) , body mass index ( BMI ) and heart rate ( HR ) at dual-source computed tomography coronary angiography ( DSCT-CA ) .


A total of 423 patients were prospectively enrolled and were randomly assigned to four groups .


The control group received 80 ml CM at 5 ml/s .


For the HR-optimized group , the injection duration was the same as the scan duration plus 8 s.


In the Body-optimized group , the dose of CM was tailored to BW and BMI .


In the HR + Body-optimized group , CM protocols tailored to body size and scan duration were applied .


Individual variability of arterial attenuation and incidence of arterial over-opacification ( attenuation > 500 HU ) in the four groups were compared .


Correlations between BW , BMI , HR , and arterial attenuations were evaluated in the four groups , respectively .


Reduced individual variability of arterial attenuation and a significantly lower incidence of arterial over-opacification were found in the Body-optimized group and HR + Body-optimized group .


Arterial attenuation was inversely correlated with BW , BMI , and HR in the control group , inversely correlated with BW and BMI in the HR-optimized group , and inversely correlated with HR in the Body-optimized group .


In the HR + Body-optimized group , arterial attenuation was not significantly correlated with BW , BMI , or HR respectively .


CM protocols individually tailored to BW , BMI , and HR can lead to reduced individual variability and a lower incidence of over-opacification of arterial attenuation , but also can reduce the influence of BW , BMI , and HR on arterial attenuations at DSCT-CA .


The probability and risk of operations increase in patients with type 2 diabetes mellitus .


For diabetic patients , blood glucose control is a key factor to improving the prognosis of surgery .


During perioperative period , insulin therapy is usually advised to be used for surgical patients with type 2 diabetes .


However , the insulin regimen which one is better remains controversial .


In this study , we estimated the efficacy , safety and advantage of different insulin therapy strategy during perioperative period .


A total of 1086 cases of surgical patients with type 2 diabetes mellitus enrolled in the present study .


According to the glucose level at admission , all patients were divided into relatively high glucose group ( group A , fasting blood glucose ( FBG ) 13.9 mmol/L ) and higher glucose group ( group B , FBG > 13.9 mmol/L ) .


Patients in group A randomly accepted premixed insulin twice a day , or basal insulin plus oral medications , and were divided into group A1 and A2 respectively .


Patients in group B randomly received premixed insulin twice daily , basal insulin plus oral hypoglycemic agents , or basal insulin plus preprandial insulin , and were divided into group B1 , B2 and B3 respectively .


The data of the preoperative preparation time , the daily doses of insulin used in different periods , postoperative incision healed installments , hypoglycemic events , the total hospitalization time , postoperative complications were all collected and statistically analyzed .


Compared the main outcome measures in groups treated by premixed insulin therapy , both in preoperative preparation and postoperative period , the daily insulin dosage and the frequency of hypoglycemic events were decreased in groups treated by basal insulin therapy ( P < 0.05 ) .


The preoperative preparation time and the total hospitalization time in groups with basal insulin therapy were shorter than that in groups with premixed insulin therapy ( P < 0.05 ) .


The incision healing rate of stage I , II and III among different therapy protocols were significantly different ( P < 0.05 ) .


Basal insulin therapy could be used in diabetic patients undergoing elective major and medium surgery during whole perioperative period .


Basal insulin therapy strategy , including a single injection of basal insulin and basal insulin plus preprandial insulin injection subcutaneously , is superior to premixed insulin therapy in the perioperative blood glucose management , and it could be viewed as the best choice in glucose control during perioperative period .


Women have unfavorable prognosis after myocardial infarction ( MI ) .


This text describes sex differences in mortality and in the power of risk predictors in contemporarily-treated MI patients .


A population of 4141 MI patients ( 26.5 % females ) was followed up for 5years .


Effects of sex and age on total mortality were investigated by multivariable Cox analysis .


Mortality predictors were investigated by receiver-operator characteristics analysis .


Stepwise multivariable Cox regression was used to create sex-specific predictive models .


Thirty-day mortality was 1.5-fold higher in women .


However , sex was not a significant mortality predictor in a model adjusted for age .


Predictors for 5-year mortality performed differently in male and female patients .


In women , a sex-specific model provided better risk stratification than a sex-neutral model .


The unfavorable prognosis of female MI patients can be explained by advanced age .


Sex-specific predictive models might improve risk stratification in female survivors of acute MI .


The aim of this study was to compare the outcomes of dorsal onlay urethroplasty using buccal mucosa graft ( BMG ) versus penile skin flap ( PSF ) in the repair of long anterior urethral strictures .


Patients with long anterior urethral strictures were randomized to receive either dorsal onlay BMG urethroplasty or PSF urethroplasty .


All patients were evaluated preoperatively and during follow-up with the International Prostate Symptom Score ( IPSS ) and uroflowmetry .


Success was reported when there were no obstructive symptoms on IPSS , with a peak urinary ow rate ( Qmax ) of at least 15 ml/s .


Failure was reported in patients with obstructive symptoms , Qmax less than 15 ml/s and evidence of recurring stricture on urethrography .


The study included 19 and 18 patients in the BMG and PSF groups , respectively .


The mean operative time was significantly shorter in the BMG than in the PSF group .


The success rate was higher in the BMG than in the PSF group ( 89.5 % vs 83.3 % ) , but not statistically significant different .


The PSF group included one case of extensive skin loss , three cases with superficial skin necrosis and two with minor penile torsion .


In the BMG group , there were three cases of perioral numbness and another three had increased salivation .


The incidence of troublesome postvoid urinary dribbling was significantly higher in the PSF than in the BMG group .


After 6 months of urethroplasty , patient satisfaction was statistically significantly higher in the BMG than in the PSF group .


BMG and PSF dorsal onlay urethroplasty had similar success rates .


However , BMG is technically easier , takes less operative time and has a potential advantage in reducing postoperative morbidity , therefore leading to satisfaction for most patients .


Pulpotomy is the common therapy for cariously exposed pulps in symptom-free primary molar teeth .


Formocresol ( FC ) is considered the gold standard dressing agent for pulpotomy , but concerns have been raised over the years about its safety .


Other alternative pulpotomy agents have been investigated and suggested .


The objective was to evaluate and compare the clinical and radiographic response of FC and white mineral trioxide aggregate ( MTA ) as pulpotomy materials on primary molars .


Fifty primary molars , with deep carious lesion that exposed a vital but asymptomatic pulp , in 37 children aged 4-7 years were treated with conventional pulpotomy procedure .


The teeth were divided randomly into two groups .


Group I ( FC ) and group II ( MTA ) .


The treated teeth were evaluated clinically and radiographically and were followed-up for 12 months .


At the end of the 12 months follow-up , the clinical success rates for FC and MTA were 81 % and 100 % , respectively .


There was a statistically significant difference ( P = 0.04 ) between the clinical success rates of FC and MTA .


While the radiographic success rates for FC and MTA were 81 % and 96 % , respectively , there was no statistically significant difference between the radiographic success of MTA and FC .


White MTA showed a higher clinical and radiographic success rate when compared to FC as a pulpotomy agent in vital primary molars , and it has a potential to become a replacement for FC in primary molars .


Diabetic nephropathy ( DN ) is a serious and common complication of diabetes mellitus leading to end-stage renal disease in up to 30 % of diabetic patients .


The first manifestation of DN in humans is microalbuminuria , which arises from the increased passage of albumin through the glomerular filtration barrier .


Reactive oxygen species , inflammatory cytokines , and growth factors are key players in the context of damage to the glomerular filtration barrier .


In this study the herbal combination Canephron ( ) N , containing lovage root , rosemary leaves , and centaury herb , was administered to patients with DN to study the effects on microalbuminuria and overall oxidant/antioxidant status .


An open study involving 59 patients with DN was performed to compare the effects of Canephron N administered concomitantly with standard antidiabetic therapy and an angiotensin-converting enzyme ( ACE ) inhibitor , with the standard therapy and ACE inhibitor treatment alone .


After 6 months of therapy the level of microalbuminuria decreased significantly in the study group compared with the control group .


Canephron N had a positive effect on the antioxidant defense status and lipid peroxidation levels .


In addition , liver aminotransferase levels did not change .


With respect to the excellent tolerability , the study results encourage use of the herbal combination as an add-on therapy in patients with DN .


The aim of this study was to assess the feasibility of hybrid coronary revascularization ( HCR ) in patientswith multivessel coronary artery disease ( MVCAD ) referred for standard coronary artery bypass grafting ( CABG ) .


Conventional CABG is still the treatment of choice in patients with MVCAD .


However , the limitations of standard CABG and the unsatisfactory long-term patency of saphenous grafts are commonly known .


A total of 200 patients with MVCAD involving the left anterior descending artery ( LAD ) and a critical ( > 70 % ) lesion in at least 1 major epicardial vessel ( except the LAD ) amenable to both PCI and CABG and referred for conventional surgical revascularization were randomly assigned to undergo HCR or CABG ( in a 1:1 ratio ) .


The primary endpoint was the evaluation of the safety of HCR .


The feasibility was defined by the percent of patients with a completeHCR procedure and the percent of patients with conversions to standard CABG .


The occurrence of major adverse cardiac events such as death , myocardial infarction , stroke , repeated revascularization , and major bleeding within the 12-month period after randomization was also assessed .


Most of the pre-procedural characteristics were similar in the 2 groups .


Of the patients in the hybrid group , 93.9 % had complete HCR and 6.1 % patients were converted to standard CABG .


At 12 months , the rates of death ( 2.0 % vs. 2.9 % , p = NS ) , myocardial infarction ( 6.1 % vs. 3.9 % , p = NS ) , major bleeding ( 2 % vs. 2 % , p = NS ) , and repeat revascularization ( 2 % vs. 0 % , p = NS ) were similar in the 2 groups .


In both groups , no cerebrovascular incidents were observed .


HCR is feasible in select patients with MVCAD referred for conventional CABG .


( Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease [ POL-MIDES ] ; NCT01035567 ) .


In this study , we sought to identify a criterion for the intermediate-risk grouping of patients with cervical cancer who exhibit any intermediate-risk factor after radical hysterectomy .


In total , 2158 patients with pathologically proven stage IB-IIA cervical cancer with any intermediate-risk factor after radical hysterectomy were randomly assigned to two groups , a development group and a validation group , at a ratio of 3:1 ( 1620 patients :538 patients ) .


To predict recurrence , multivariate models were developed using the development group .


The ability of the models to discriminate between groups was validated using the log-rank test and receiver operating characteristic ( ROC ) analysis .


Four factors ( histology , tumour size , deep stromal invasion ( DSI ) , and lymphovascular space involvement ( LVSI ) ) were significantly associated with disease recurrence and included in the models .


Among the nine possible combinations of the four variables , models consisting of any two of the four intermediate-risk factors ( tumour size 3cm , DSI of the outer third of the cervix , LVSI , and adenocarcinoma or adenosquamous carcinoma histology ) demonstrated the best performance for predicting recurrence .


This study identified a ` four-factor model ' in which the presence of any two factors may be useful for predicting recurrence in patients with cervical cancer treated with radical hysterectomy .