Using the Wechsler Intelligence Scales , Kaufman Assessment Battery for Children , and Raven 's Progressive Matrices , we estimated full-scale intelligence quotient ( FSIQ ) and , when available , verbal IQ ( VIQ ) , performance IQ ( PIQ ) , working memory index ( WMI ) , and processing speed index ( PSI ) .


Among the 137 participants ( HFRT arm n = 71 , STRT arm n = 66 , 63.5 % males ) , mean ( SD ) ages at diagnosis and assessment respectively were 9.3 ( 3.2 ) years of age ( 40.8 % < 8years of age at diagnosis ) and 14.6 ( 4.3 ) years of age .


Mean ( SD ) FSIQ was 88 ( 19 ) , and mean intergroup difference was 3.88 ( 95 % confidence interval : -2.66 to 10.42 , P = .24 ) .


No significant differences were found in children > 8years of age at diagnosis .


In children < 8years of age at diagnosis , a marginally significant trend toward higher VIQ was found in those treated in the HFRT arm ; a similar trend was found for PSI but not for PIQ , WMI , or FSIQ ( mean intergroup differences were : 12.02 for VIQ [ 95 % CI : 2.37-21 .67 ; P = .02 ] ; 3.77 for PIQ [ 95 % CI : -5.19 to 12.74 ; P > .10 ] ; 5.20 for WMI [ 95 % CI : -2.07 to 12.47 ; P > .10 ] ; 10.90 for PSI [ 95 % CI : -1.54 to 23.36 ; P = .08 ] ; and 5.28 for FSIQ [ 95 % CI : -4.23 to 14.79 ; P > .10 ] ) .


HFRT was associated with marginally higher VIQ in children < 8years of age at diagnosis , consistent with a previous report using questionnaire-based data .


However , overall cognitive ability was not significantly different .


Compare the treatment outcome after scaling and root-planing using local anesthesia gel or injected local anesthesia .


Thirty-eight patients with periodontitis and good general health were included in a randomized , single-blind , split-mouth clinical trial .


Probing depths and clinical attachment levels were recorded at baseline and 6weeks after treatment .


Performed treatment procedures were scaling and root planing using two types of local anesthesia for separate treatment appointments .


Anesthetics used were intra-pocket lidocaine and prilocaine gel ( 2.5 % each ) and injected articaine ( 1:100,000 adrenaline ) .


Type of anesthesia for first appointment was randomized and switched for second appointment .


Patients ' pain perception and anesthesia acceptance were recorded on questionnaires .


No influence of applied type of anesthesia could be detected for change of probing pocket depths and clinical attachment level ( p > 0.05 ) .


These findings are valid even for deeper pockets .


Gel-group had significant higher intra-operative pain perception .


In retrospect 69 % of patients favored gel .


Treatment outcome is not compromised by use of anesthesia gel in comparison to injected anesthesia .


The same beneficial results for probing pocket depths and clinical attachment gain could be detected .


The majority of patients prefer local anesthesia gel despite a slightly greater procedural discomfort .


To explore the clinical values of detecting drug related molecules excision repair cross complementing 1 ( ERCC1 ) and top-isomerase I ( TOPO I ) in individualized therapies of metastatic colorectal cancer .


From June 2009 to December 2011 , 90 patients at Huadong Hospital with metastatic colorectal cancer were randomly separated into 2 groups after operation .


Each group had 45 patients without difference in gender , age or TNM stage .


The expressions of ERCC1 and TOPO Iin cancer tissues were detected by immunohistochemical staining .


The testing group received individualized chemotherapies following the expression results while the control group had random chemotherapies .


The survival difference between two groups was analyzed by log-rank test and Kaplan-Meier analysis .


And curative effect was analyzed by ( 2 ) or Fisher 's analysis .


The expressions of ERCC1 and TOPO I had no statistical significance between two groups ( both P > 0.05 ) .


In the testing group , the median survival time was 281 days and the beneficial ratio 51.1 % ( 23/45 ) versus 246 days and 44.4 % ( 20/45 ) respectively in the control group .


The inter-group comparisons of survival ( P = 0.235 ) and curative effect ( ( 2 ) = 0.04 , P > 0.05 ) showed no statistical significance .


In the estimated drug tolerated group ( ERCC1 high expression or TOPO I low expression ) , the median survival time was 196 days and the beneficial ratio 4/14 versus 304 days and 51.3 % ( 39/76 ) in the estimated drug sensitive group .


The inter-group comparisons of survival and curative effect ( both P < 0.05 ) had statistical significance .


The median survival time and beneficial ratio significantly increased in estimated drug sensitive group than those in estimated drug tolerated group .


The expression of drug related molecule in colorectal cancer tissue is significantly associated with curative effect in patients .


Patients with down-regulated ERCC1 on Oxaliplatin or up-regulated TOPO Ion Irinotecan have longer survival and better curative effect .


And chemotherapies guided by drug related molecule detection may boost curative effects in metastatic colorectal cancer .


Biodegradable-polymer drug-eluting stents ( BP-DES ) were developed to be as effective as second-generation durable-polymer drug-eluting stents ( DP-DES ) and as safe > 1 year as bare-metal stents ( BMS ) .


Thus , very late stent thrombosis ( VLST ) attributable to durable polymers should no longer appear .


To address these early and late aspects , 2291 patients presenting with acute or stable coronary disease needing stents 3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES , second-generation everolimus-eluting DP-DES , or thin-strut silicon-carbide-coated BMS in 8 European centers .


All patients were treated with aspirin and risk-adjusted doses of prasugrel .


The primary end point was combined cardiac death , myocardial infarction , and clinically indicated target-vessel revascularization within 2 years .


The combined secondary safety end point was a composite of VLST , myocardial infarction , and cardiac death .


The cumulative incidence of the primary end point was 7.6 % with BP-DES , 6.8 % with DP-DES , and 12.7 % with BMS .


By intention-to-treat BP-DES were noninferior ( predefined margin , 3.80 % ) compared with DP-DES ( absolute risk difference , 0.78 % ; -1.93 % to 3.50 % ; P for noninferiority 0.042 ; per protocol P = 0.09 ) and superior to BMS ( absolute risk difference , -5.16 ; -8.32 to -2.01 ; P = 0.0011 ) .


The 3 stent groups did not differ in the combined safety end point , with no decrease in events > 1 year , particularly VLST with BP-DES .


In large vessel stenting , BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS , but without evidence for better safety nor lower VLST rates > 1 year .


Findings challenge the concept that durable polymers are key in VLST formation .


http://www.clinicaltrials.gov .


Unique identifier : NCT01166685 .


The World Health Organization recommends vitamin A supplementation ( VAS ) at routine vaccination contacts after 6 months of age based on the assumption that it reduces mortality by 24 % .


The policy has never been evaluated in randomized controlled trials for its effect on overall mortality .


We conducted a randomized double-blind trial to evaluate the effect of VAS with vaccines .


We randomized children aged 6 to 23 months 1:1 to VAS ( 100000 IU if aged 6-11 months , 200000 IU if aged 12-23 months ) or placebo at vaccination contacts in Guinea-Bissau .


Mortality rates were compared in Cox proportional-hazards models overall , and by gender and vaccine .


Between August 2007 and November 2010 , 7587 children were enrolled .


Within 6 months of follow-up 80 nonaccident deaths occurred ( VAS : 38 ; placebo : 42 ) .


The mortality rate ratio ( MRR ) comparing VAS versus placebo recipients was 0.91 ( 95 % confidence interval 0.59-1 .41 ) and differed significantly between boys ( MRR 1.92 [ 0.98-3 .75 ] ) and girls ( MRR 0.45 [ 0.24-0 .87 ] ) ( P = .003 for interaction between VAS and gender ) .


At enrollment , 42 % ( 3161/7587 ) received live measles vaccine , 29 % ( 2154/7587 ) received inactivated diphtheria-tetanus-pertussis-containing vaccines , and 21 % ( 1610/7587 ) received both live and inactivated vaccines .


The effect of VAS did not differ by vaccine group .


This is the first randomized controlled trial to assess the effect of the policy on overall mortality .


VAS had no overall effect , but the effect differed significantly by gender .


More trials to ensure an optimal evidence-based vitamin A policy are warranted .


Sedation-analgesia is recommended for comfortable colonoscopy procedures , which are invasive and can be painful .


This study aimed to compare the combinations of propofol-alfentanil and propofol-fentanyl for sedation-analgesia in elective colonoscopy patients .


This prospective and randomized study was planned in ASA I-II groups and included 80 patients between the ages of 18 and 65 years .


Sedation-analgesia induction was performed as 1 g.kg ( -1 ) fentanyl , 1mg .


kg ( -1 ) propofol in the propofol-fentanyl group ( Group PF ) and 10 g.kg ( -1 ) alfentanil , 1mg .


kg ( -1 ) propofol in the propofol-alfentanil group ( Group PA ) .


Patients ' scores were limited to 3-4 values on the Ramsey Sedation Scale ( RSS ) by 0.5 mg.kg ( -1 ) bolus additional doses of propofol in sedation-analgesia maintenance .


We recorded demographical data , heart rate , mean arterial pressure ( MAP ) , oxygen saturation of hemoglobin ( SpO2 ) , RSS value , colonoscopy time , total dose of propofol , complications , recovery time , and discharge time , as well as colonoscopist and patient satisfaction scores .


MAP at the 15 ( th ) minute in Group PA was significantly higher than in Group PF ( p = 0.037 ) .


Group PA 's beginning mean heart rate was higher than the mean heart rate at subsequent readings ( p = 0.012 , p = 0.002 ) .


The mean total propofol dose of Group PA was significantly higher than the total dose of Group PF ( p = 0.028 ) .


The mean recovery time of Group PA was significantly longer than that of Group PF ( p = 0.032 ) .


Fentanyl provides better operative conditions and reduces the need for additional propofol doses .


These advantages cause a shorter recovery time .


Therefore , propofol-fentanyl is superior to the propofol-alfentanil for sedation-analgesia in colonoscopy .


To investigate the immediate effects of manipulation of bilateral sacroiliac joints ( SIJs ) on the plantar pressure distribution in asymptomatic participants in the standing position .


Randomized , controlled , double-blind clinical trial .


Sixty-two asymptomatic men and women ( mean age , 20.662.56 years ) randomly assigned to 2 groups .


The experimental group underwent mobilization without tension of the hips in the supine position and high-velocity , low-amplitude manipulation in the SIJs bilaterally .


The control group underwent only mobilization , without tension of the hips in supine position .


Pre - and postintervention outcomes measured by an assessor blinded to the treatment allocation of the participants included a baropodometric analysis performed by using a force platform .


Baseline between-group differences were examined with a Kolmogorov-Smirnov test .


A chi-square test was used for categorical data .


Analysis of covariance ( ANCOVA ) was used to assess differences between groups , with the preintervention value as covariant ( 95 % confidence level ) .


At baseline , no variables significantly differed between groups .


Baropodometric analysis showed statistically significant differences in the location of the maximum pressure point in the experimental group ( p = 0.028 ) .


Pre - and postintervention analysis with ANCOVA showed statistically significant differences between both groups in the left hindfoot load percentage ( interaction p = 0.0259 ; ANCOVA p = 0.0277 ) , right foot load percentage ( ANCOVA p = 0.0380 ) , and surface of the right forefoot ( interaction p = 0.0038 ) .


There was also a significant effect in the variables that analyze the entire foot ( left foot : surface [ interaction p = 0.0452 ] , percentage of load [ ANCOVA p = 0.0295 ] ) and between both groups ( right foot : weight [ interaction p = 0.0070 ; ANCOVA p = 0.0296 ] ) .


Sacroiliac joint manipulation applied bilaterally in asymptomatic persons resulted in immediate changes in load distribution on plantar support in the standing position .


Study limitations and suggestions for future studies are discussed .


New-onset diabetes after transplantation ( NODAT ) is a common complication after renal transplantation .


There are limited available oral drugs to treat hyperglycaemia in this population owing to reduced renal function , potential interactions with immunosuppressive drugs and adverse effects such as hypoglycaemic events that may increase the cardiovascular risk .


This study was initiated to investigate efficacy and safety of sitagliptin treatment that may represent a novel alternative in renal transplant recipients .


Nineteen long-term stable renal transplant recipients with NODAT were included in a controlled , cross-over study and randomized to first receive either sitagliptin 50-100 mg/day or a sitagliptin-free period of 4 weeks .


Median age ( interquartile range , IQR ) was 67 ( 62-72 ) years ( 12 males/7 females ) , all studied 1 ( 1-3 ) year after transplantation .


The immunosuppressive regimen was a triple calcineurin inhibitor-based therapy .


Oral glucose tolerance test ( OGTT ) with insulin and C-peptide responses and laser Doppler ( LD ) flowmetry assessment of endothelial function were performed at baseline and after each treatment period .


Home measurements of plasma glucose were performed daily during the study .


The median ( IQR ) first - and second-phase insulin secretion responses increased significantly by 56.3 % ( 45.2-112 .6 % , P = 0.005 ) and 39.3 % ( 26.5-81 .0 % , P = 0.006 ) , respectively , following sitagliptin treatment as compared with no sitagliptin treatment .


Fasting and 2-h plasma glucose concentrations fell significantly { 0.9 mmol/L [ 0.5-1 .7 mmol/L ( 16.2 mg/dL ) , P = 0.003 ] and 2.9 mmol/L [ 0.5-6 .4 mmol/L ( 52.3 mg/dL ) , P = 0.004 ] , respectively } , as did also home measurements of plasma glucose .


Endothelial function and plasma markers of cardiovascular risk were unaffected .


No serious adverse events were observed .


Two mild and asymptomatic hypoglycaemic episodes were observed in combination with glipizide .


Sitagliptin increases insulin secretion and reduces fasting and postprandial plasma glucose in renal transplant recipients with NODAT .


The short-term treatment was well tolerated , and sitagliptin seems safe in this population .


Sepsis , a leading cause of death in critically ill patients , is the result of complex interactions between the infecting microorganisms and the host responses that influence clinical outcomes .


We evaluated the prognostic value of presepsin ( sCD14-ST ) , a novel biomarker of bacterial infection , and compared it with procalcitonin ( PCT ) .


This is a retrospective , case-control study of a multicenter , randomized clinical trial enrolling patients with severe sepsis or septic shock in ICUs in Italy .


We selected 50 survivors and 50 non-survivors at ICU discharge , matched for age , sex and time from sepsis diagnosis to enrollment .


Plasma samples were collected 1 , 2 and 7 days after enrollment to assay presepsin and PCT .


Outcome was assessed 28 and 90 days after enrollment .


Early presepsin ( day 1 ) was higher in decedents ( 2,269 pg/ml , median ( Q1 to Q3 ) , 1,171 to 4,300 pg/ml ) than in survivors ( 1,184 pg/ml ( median , 875 to 2,113 ) ; P = 0.002 ) , whereas PCT was not different ( 18.5 g/L ( median 3.4 to 45.2 ) and 10.8 g/L ( 2.7 to 41.9 ) ; P = 0.31 ) .


The evolution of presepsin levels over time was significantly different in survivors compared to decedents ( P for time-survival interaction = 0.03 ) , whereas PCT decreased similarly in the two groups ( P = 0.13 ) .


Presepsin was the only variable independently associated with ICU and 28-day mortality in Cox models adjusted for clinical characteristics .


It showed better prognostic accuracy than PCT in the range of Sequential Organ Failure Assessment score ( area under the curve ( AUC ) from 0.64 to 0.75 vs. AUC 0.53 to 0.65 ) .


In this multicenter clinical trial , we provide the first evidence that presepsin measurements may have useful prognostic information for patients with severe sepsis or septic shock .


These preliminary findings suggest that presepsin may be of clinical importance for early risk stratification .


To compare the efficacy of celecoxib for treatment of withdrawal headache vs prednisone in patients with medication overuse headache ( MOH ) .


In this prospective , double-blind , parallel-group clinical trial , 97 consecutive subjects with MOH were randomized ( simple randomization using computer-generated numbers ) for treatment with either 400mg/day celecoxib ( for the first 5 days then decreased at a rate of 100mg every 5 days ) or prednisone 75 mg/day orally ( for the first 5 days then tapered off every 5 days ) .


Subjects who met the International Headache Society criteria for MOH were included in the trial .


The change in headache days and intake of rescue medication were considered as primary outcomes while the change in headache severity defined as a secondary outcome .


Patients treated with celecoxib experienced lower headache intensity during the first 3 weeks after withdrawal ( after 3 weeks , the median of visual analog scale was 3 for patients in celecoxib group vs 4.5 for prednisone group [ P < .001 ] ) .


However , headache frequency and the need for rescue medication intake were not different between 2 groups .


During withdrawal in MOH , in order to reduce headache days or rescue medication intake , using either of celecoxib or prednisone as a bridge is not different .


Short-term dietary glucose supplementation has been shown to accelerate the gastric emptying rate of both glucose and fructose solutions .


The aim of this study was to examine gastric emptying rate responses to monosaccharide ingestion following short-term dietary fructose supplementation .


The gastric emptying rate of a fructose solution containing 36 g of fructose and an equicaloric glucose solution containing 39.6 g glucose monohydrate were measured in 10 healthy non-smoking men with and without prior fructose supplementation ( water control ) using a randomized crossover design .


Gastric emptying rate was assessed for a period of 1 h using the [ ( 13 ) C ] breath test with sample collections at baseline and 10-min intervals following drink ingestion .


Additionally , appetite ratings of hunger , fullness , and prospective food consumption were recorded at baseline and every 10 min using visual analog scales .


Increased dietary fructose ingestion resulted in significantly accelerated half-emptying time of a fructose solution ( mean = 48 , SD = 6 versus 58 , SD = 14 min control ; P = 0.037 ) , whereas the emptying of a glucose solution remained unchanged ( mean = 85 , SD = 31 versus 78 , SD = 27 min control ; P = 0.273 ) .


Time of maximal emptying rate of fructose was also significantly accelerated following increased dietary fructose intake ( mean = 33 , SD = 6 versus 38 , SD = 9 min control ; P = 0.042 ) , while it remained unchanged for glucose ( mean = 45 , SD = 14 versus 44 , SD = 14 min control ; P = 0.757 ) .


No effects of supplementation were observed for appetite measures .


Three d of supplementation with 120 g/d of fructose resulted in an acceleration of gastric emptying rate of a fructose solution but not a glucose solution .


To evaluate intraocular lens ( IOL ) axial movements and refractive changes during a 6-month follow-up period after femtosecond laser-assisted cataract surgery and conventional cataract surgery , investigate the influence of capsulorhexis features on postoperative IOL axial changes , and assess the prediction error for both techniques .


Eighty eyes of 80 candidates for cataract extraction were randomized into two groups : femtosecond laser ( 40 eyes ) and manual ( 40 eyes ) .


The overall anterior chamber depth variation was significantly lower in the femtosecond laser group compared to the manual group during follow-up ( P < .001 ) .


At 30 and 180 days postoperatively , the mean spherical equivalent showed a hyperopic shift ( 0.090.28 diopters [ D ] ) in the femtosecond laser group and a myopic shift in the manual group ( -0.250.18 D ) .


Median absolute error was not significantly different between the two groups with standard formulas ranging between 0.29 and 0.64 ( Hoffer Q ) in the femtosecond laser group and between 0.24 ( SRK-T ) and 0.55 D ( Hoffer Q ) in the manual group .


There was a significant lower deviation from intended versus achieved capsulotomy/capsulorhexis area in the femtosecond laser group ( P < .001 ) compared to the manual group .


The femtosecond laser group showed better IOL centration compared to the manual group at all time periods ( P < .001 ) .


Femtosecond laser-assisted cataract surgery was related to a lower overall variability of anterior chamber depth compared to conventional cataract surgery with more stable postoperative refraction .


The two techniques did not show significant differences of prediction error .


Insulin-sensitive tissues ( muscle , liver ) of individuals with obesity and type 2 diabetes mellitus are in a state of low-grade inflammation , characterised by increased Toll-like receptor ( TLR ) expression and TLR-driven signalling .


However , the cause of this mild inflammatory state is unclear .


We tested the hypothesis that a prolonged mild increase in plasma NEFA will increase TLR expression and TLR-driven signalling ( nuclear factor B [ NFB ] and mitogen-activated kinase [ MAPK ] ) and impair insulin action in muscle of lean healthy individuals .


Twelve lean , normal-glucose-tolerant participants were randomised to receive a 48 h infusion ( 30 ml/h ) of saline or Intralipid followed by a euglycaemic-hyperinsulinaemic clamp .


Vastus lateralis muscle biopsies were performed before and during the clamp .


Lipid infusion impaired insulin-stimulated IRS-1 tyrosine phosphorylation and reduced peripheral insulin sensitivity ( p < 0.01 ) .


The elevation in circulating NEFA increased expression of TLR3 , TLR4 and TLR5 , and several MAPK ( MAPK8 , MAP4K4 , MAP2K3 ) and inhibitor of B kinase-NFB ( CHUK [ IKKA ] , c-REL [ REL ] and p65 [ RELA , NFKB3 , p65 ] ) signalling genes ( p < 0.05 ) .


The lipid infusion also increased extracellular signal-regulated kinase ( ERK ) phosphorylation ( p < 0.05 ) and tended to reduce the content of inhibitor of kappa B ( p = 0.09 ) .


The muscle content of most diacylglycerol , ceramide and acylcarnitine species was unaffected .


In summary , insulin resistance induced by prolonged low-dose lipid infusion occurs together with increased TLR-driven inflammatory signalling and impaired insulin-stimulated IRS-1 tyrosine phosphorylation .


A sustained , mild elevation in plasma NEFA is sufficient to increase TLR expression and TLR-driven signalling ( NFB and MAPK ) in lean individuals .


The activation of this pathway by NEFA may be involved in the pathogenesis of insulin resistance in humans .


ClinicalTrials.gov NCT01740817 .


In children with cerebral palsy , does a 6-month physical activity stimulation program improve physical activity , mobility capacity , fitness , fatigue and attitude towards sports more than usual paediatric physiotherapy ?


Multicentre randomised controlled trial with concealed allocation , blinded assessments and intention-to-treat analysis .


Forty-nine walking children ( 28 males ) aged 7-13 years with spastic cerebral palsy and severity of the disability classified as Gross Motor Function Classification System level I-III .


The intervention group followed a 6-month physical activity stimulation program involving counselling through motivational interviewing , home-based physiotherapy , and 4 months of fitness training .


The control group continued their usual paediatric physiotherapy .


Primary outcomes were walking activity ( assessed objectively with an activity monitor ) and parent-reported physical activity ( Activity QUESTIONnaire for Adults and Adolescents ) .


Secondary outcomes were : mobility capacity , consisting of Gross Motor Function Measure-66 ( GMFM-66 ) , walking capacity and functional strength , fitness ( aerobic and anaerobic capacity , muscle strength ) , self-reported fatigue , and attitude towards sport ( child and parent ) .


Assessments were performed at baseline , 4 months , 6 months and 12 months .


There were no significant intervention effects for physical activity or secondary outcomes at any assessment time .


Positive trends were found for parent-reported time at moderate-to-vigorous intensity ( between-group change ratio = 2.2 , 95 % CI 1.1 to 4.4 ) and GMFM-66 ( mean between-group difference = 2.8 points , 95 % CI 0.2 to 5.4 ) at 6 months , but not at 12 months .


There was a trend for a small , but clinically irrelevant , improvement in the children 's attitudes towards the disadvantages of sports at 6 months , and towards the advantages of sports at 12 months .


This physical activity stimulation program , that combined fitness training , counselling and home-based therapy , was not effective in children with cerebral palsy .


Further research should examine the potential of each component of the intervention for improving physical activity in this population .


NTR2099 .


To evaluate glucose-lowering treatment strategies with linagliptin and metformin in people with newly diagnosed type 2 diabetes and marked hyperglycaemia , a prevalent population for which few dedicated studies of oral antidiabetes drugs have been conducted .


A total of 316 patients , with type 2 diabetes diagnosed for 12months and with glycated haemoglobin ( HbA1c ) concentration in the range 8.5-12 .0 % , were randomized 1:1 to double-blind , free-combination treatment with linagliptin 5mg once daily and metformin twice daily ( uptitrated to 2000mg/day maximum ) or to linagliptin monotherapy .


The primary endpoint was change in HbA1c concentration from baseline at week 24 ( per-protocol completers ' cohort : n = 245 ) .


The mean ( standard deviation ) age and HbA1c at baseline were 48.8 ( 11.0 ) years and 9.8 ( 1.1 ) % , respectively .


At week 24 , the meanstandard error ( s.e. ) HbA1c decreased from baseline by -2.80.1 % with linagliptin/metformin and -2.00.1 % with linagliptin ; a treatment difference of -0.8 % ( 95 % confidence interval -1.1 to -0.5 ; p < 0.0001 ) .


Similar results were observed in a sensitivity analysis based on intent-to-treat principles : adjusted means.e .


changes in HbA1c of -2.70.1 % and -1.80.1 % , respectively ; treatment difference of -0.9 % ( 95 % CI -1.3 to -0.6 ; p < 0.0001 ) .


A treatment response of HbA1c < 7.0 % was achieved by 61 and 40 % of patients in the linagliptin/metformin and linagliptin groups , respectively .


Few patients experienced drug-related adverse events ( 8.8 and 5.7 % of patients in the linagliptin/metformin and linagliptin groups , respectively ) .


Hypoglycaemia occurred in 1.9 and 3.2 % of patients in the linagliptin/metformin and linagliptin groups , respectively ( no severe episodes ) .


Body weight decreased significantly with the combination therapy ( -1.3 kg between-group difference ; p = 0.0033 ) .


Linagliptin in initial combination with metformin in patients with newly diagnosed type 2 diabetes and marked hyperglycaemia , an understudied group , elicited significant improvements in glycaemic control with a low incidence of hypoglycaemia , weight gain or other adverse effects .


These results support early combination treatment strategies and suggest that newly diagnosed patients with marked hyperglycaemia may be effectively managed with oral , non-insulin therapy .


To assess post-operative pain in patients who underwent arthroscopic anterior cruciate ligament ( ACL ) reconstruction by the all-inside technique .


A prospective randomized comparative parallel trial was performed in 2010-2011 including all patients who underwent an ACL reconstruction in an orthopaedic department in accordance with the CONSORT statement 2010 .


Patients were randomized to the surgical procedure , all-inside or classical , and were blinded to the surgical technique .


Primary evaluation criterion was pain assessed on the Visual Analogical Scale 1 month after surgery .


Secondary parameters were analgesic consumption , tunnel positioning on X-ray according to Aglietti 's criteria and functional evaluation at six months with IKDC score .


None of the patients was lost to follow-up .


46 consecutive patients were included , 23 in each group , mean age 29.39 years .


Two patients were excluded due to postoperative complications that required early revision surgery .


Forty-four patients were analyzed , 22 in each group .


At one month , the pain level was 3.25.5 for the all-inside group and 8.610 for the classical group , p = 0.057 ( 95 % CI 0.5-10 .4 ) .


Postoperative analgesic consumption was similar .


The position of the tibial tunnels was better with the all-inside method , p = 0.002 ( 95 % CI 1.9-6 .6 % ) .


There was no significant difference in the mean IKDC subjective score at six months , p = 0.92 ( 95 % CI-9 .7 to 9.2 ) .


At one month , the pain level seemed lower in the all-inside group than in the classical group , at the limit of statistical significance because the study was underpowered .


The all-inside technique is a reliable procedure with very good results for pain , stability and knee function .


I ; Therapeutic study .


To evaluate the effect of oral administration of probiotics on intestinal colonization with drug-resistant bacteria among preterm infants in the neonatal intensive care unit ( NICU ) .


A double-blind , randomized , placebo-controlled trial was carried out in the preterm infants who were transferred to the NICU immediately after birth .


These infants were stratified by whether they were breastfed and then randomized into test group and control group .


The test group was given probiotics from the day when enteral feeding began , while the control group was treated conventionally without probiotics .


The two groups were compared in terms of the colonization with extended-spectrum beta-lactamase-producing bacteria , as assessed by rectal swabs on days 1 , 3 , 7 , and 14 after birth , and the incidence of diseases .


Rectal colonization with drug-resistant bacteria was found in the test group ( n = 119 ) and control group ( n = 138 ) on days 1 , 3 , 7 , and 14 after birth .


There were no significant differences in the incidence of late-onset sepsis and necrotizing enterocolitis between the two groups ( P > 0.05 ) .


Among non-breastfed infants , the test group had significantly decreased rectal colonization with drug-resistant bacteria compared with the control group on day 14 after birth ( 71.1 % vs 88.9 % ; P = 0.04 ) .


No probiotic-related adverse events were observed in the study .


Oral administration of probiotics may reduce rectal colonization with drug-resistant bacteria in preterm infants under certain conditions and shows good safety .


The clinical benefit of adding a macrolide to a - lactam for empirical treatment of moderately severe community-acquired pneumonia remains controversial .


To test noninferiority of a - lactam alone compared with a - lactam and macrolide combination in moderately severe community-acquired pneumonia .


Open-label , multicenter , noninferiority , randomized trial conducted from January 13 , 2009 , through January 31 , 2013 , in 580 immunocompetent adult patients hospitalized in 6 acute care hospitals in Switzerland for moderately severe community-acquired pneumonia .


Follow-up extended to 90 days .


Outcome assessors were masked to treatment allocation .


Patients were treated with a - lactam and a macrolide ( combination arm ) or with a - lactam alone ( monotherapy arm ) .


Legionella pneumophila infection was systematically searched and treated by addition of a macrolide to the monotherapy arm .


Proportion of patients not reaching clinical stability ( heart rate < 100/min , systolic blood pressure > 90 mm Hg , temperature < 38.0 C , respiratory rate < 24/min , and oxygen saturation > 90 % on room air ) at day 7 .


After 7 days of treatment , 120 of 291 patients ( 41.2 % ) in the monotherapy arm vs 97 of 289 ( 33.6 % ) in the combination arm had not reached clinical stability ( 7.6 % difference , P = .07 ) .


The upper limit of the 1-sided 90 % CI was 13.0 % , exceeding the predefined noninferiority boundary of 8 % .


Patients infected with atypical pathogens ( hazard ratio [ HR ] , 0.33 ; 95 % CI , 0.13-0 .85 ) or with Pneumonia Severity Index ( PSI ) category IV pneumonia ( HR , 0.81 ; 95 % CI , 0.59-1 .10 ) were less likely to reach clinical stability with monotherapy , whereas patients not infected with atypical pathogens ( HR , 0.99 ; 95 % CI , 0.80-1 .22 ) or with PSI category I to III pneumonia ( HR , 1.06 ; 95 % CI , 0.82-1 .36 ) had equivalent outcomes in the 2 arms .


There were more 30-day readmissions in the monotherapy arm ( 7.9 % vs 3.1 % , P = .01 ) .


Mortality , intensive care unit admission , complications , length of stay , and recurrence of pneumonia within 90 days did not differ between the 2 arms .


We did not find noninferiority of - lactam monotherapy in patients hospitalized for moderately severe community-acquired pneumonia .


Patients infected with atypical pathogens or with PSI category IV pneumonia had delayed clinical stability with monotherapy .


clinicaltrials.gov Identifier : NCT00818610 .


Olodaterol is a long-acting 2-agonist with a 24-hour bronchodilator profile .


Two replicate , randomized , double-blind , placebo-controlled , parallel-group , Phase III trials were performed as part of a comprehensive clinical program to investigate the long-term safety and efficacy of olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease ( COPD ) receiving usual-care background therapy .


Patients received olodaterol 5 g or 10 g or placebo once daily for 48 weeks .


Coprimary end points were forced expiratory volume in 1 second ( FEV1 ) area under the curve from 0 to 3 hours ( AUC0-3 ) response ( change from baseline ) , and trough FEV1 response at 12 weeks .


Secondary end points included additional lung function assessments , use of rescue medications , FEV1 AUC response from 0 to 12 hours , and Patient Global Rating over 48 weeks .


Overall , 624 and 642 patients were evaluated in studies 1222.11 and 1222.12 , respectively .


In both studies , olodaterol 5 g and 10 g significantly improved the FEV1 AUC0-3 response ( P < 0.0001 ) and trough FEV1 ( study 1222.11 , P < 0.0001 ; study 1222.12 , P < 0.05 , post hoc ) at week 12 , with an incidence of adverse events comparable with that of placebo .


Secondary end points supported the efficacy of olodaterol .


These studies demonstrate the long-term efficacy and safety of once-daily olodaterol 5 g and 10 g in patients with moderate to very severe COPD continuing with usual-care maintenance therapy .


WARCEF randomized 2,305 patients in sinus rhythm with ejection fraction ( EF ) 35 % to warfarin ( INR 2.0-3 .5 ) or aspirin 325 mg .


Warfarin reduced the incident ischemic stroke ( IIS ) hazard rate by 48 % over aspirin in a secondary analysis .


The IIS rate in heart failure ( HF ) is too low to warrant routine anticoagulation but epidemiologic studies show that prior stroke increases the stroke risk in HF .


In this study , we explore IIS rates in WARCEF patients with and without baseline stroke to look for risk factors for IIS and determine if a subgroup with an IIS rate high enough to give a clinically relevant stroke risk reduction can be identified .


We compared potential stroke risk factors between patients with baseline stroke and those without using the exact conditional score test for Poisson variables .


We looked for risk factors for IIS , by comparing IIS rates between different risk factors .


For EF we tried cut-off points of 10 , 15 and 20 % .


The cut-off point 15 % was used as it was the highest EF that was associated with a significant increase in IIS rate .


IIS and EF strata were balanced as to warfarin/aspirin assignment by the stratified randomized design .


A multiple Poisson regression examined the simultaneous effects of all risk factors on IIS rate .


IIS rates per hundred patient years ( / 100 PY ) were calculated in patient groups with significant risk factors .


Missing values were assigned the modal value .


Twenty of 248 ( 8.1 % ) patients with baseline stroke and 64 of 2,048 ( 3.1 % ) without had IIS .


IIS rate in patients with baseline stroke ( 2.37 / 100 PY ) was greater than patients without ( 0.89 / 100 PY ) ( rate ratio 2.68 , p < 0.001 ) .


Fourteen of 219 ( 6.4 % ) patients with ejection fraction ( EF ) < 15 % and 70 of 2,079 ( 3.4 % ) with EF 15 % had IIS .


In the multiple regression analysis stroke at baseline ( p < 0.001 ) and EF < 15 % vs. 15 % ( p = 0.005 ) remained significant predictors of IIS .


IIS rate was 2.04 / 100 PY in patients with EF < 15 % and 0.95 / 100 PY in patients with EF 15 % ( p = 0.009 ) .


IIS rate in patients with baseline stroke and reduced EF was 5.88 / 100 PY with EF < 15 % decreasing to 2.62 / 100 PY with EF < 30 % .


In a WARCEF exploratory analysis , prior stroke and EF < 15 % were risk factors for IIS .


Further research is needed to determine if a clinically relevant stroke risk reduction is obtainable with warfarin in HF patients with prior stroke and reduced EF .


High intake of added sweeteners is considered to have a causal role in the pathogenesis of cardiometabolic disorders .


Especially , high-fructose intake is regarded as potentially harmful to cardiometabolic health .


It may cause not only weight gain but also low-grade inflammation , which represents an independent risk factor for developing type 2 diabetes and cardiovascular disease .


In particular , fructose has been suggested to induce plasminogen activator inhibitor-1 ( PAI-1 ) expression in the liver and to increase circulating inflammatory cytokines .


We therefore aimed to investigate , whether high-fructose diet has an impact on PAI-1 , monocyte chemoattractant protein-1 ( MCP-1 ) , e-selectin and C-reactive protein ( CRP ) concentrations in healthy humans .


We studied 20 participants ( 12 males and 8 females ) of the TUebingen FRuctose Or Glucose study .


This is an exploratory , parallel , prospective , randomized , single-blinded , outpatient , hypercaloric , intervention study .


The participants had a mean age of 30.9 2.1 years and a mean body mass index of 26.0 0.5 kg/m ( 2 ) and they received 150 g of either fructose or glucose per day for 4 weeks .


There were neither significant changes of PAI-1 , MCP-1 , e-selectin and CRP after fructose ( n = 10 ) and glucose ( n = 10 ) intervention nor treatment effects ( all P > 0.2 ) .


Moreover , we did not observe longitudinal associations of the inflammatory parameters with triglycerides , liver fat , visceral fat and body weight in the fructose group .


Temporary high-fructose intake does not seem to cause inflammation in apparently healthy people in this secondary analysis of a small feeding trial .


Studies have demonstrated that plasmakinetic enucleation of the prostate ( PKEP ) and open prostatectomy ( OP ) have equivalent short-term efficacy for large prostates , but no comparison concerning their long-term results was reported .


To demonstrate the noninferiority of PKEP to OP concerning maximum urinary flow rate ( Qmax ) at 1 yr postoperatively and to compare the long-term results of both procedures .


From 2004 to 2007 , 160 patients with prostates > 100g were randomized to receive PKEP or OP .


A total of 153 patients ( 95.6 % ) completed the noninferiority study , and 123 patients ( 76.9 % ) finished a 6-yr follow-up assessment .


The PKEP procedures were performed with 27F Karl Storz continuous flow resectoscopy and the Gyrus PlasmaKinetic device .


OP was performed by a suprapubic transvesical approach .


The primary end point was Qmax at 1 yr postoperatively .


Secondary end points included other perioperative parameters and postoperative micturition variables .


The student t test , Mann-Whitney U test , chi-square test , or Fisher exact probability test was used as appropriate .


PKEP was noninferior to OP regarding Qmax at 1 yr postoperatively .


Compared with OP , PKEP was associated with less perioperative hemoglobin decrease , shorter catheterization time , and shorter postoperative hospital stay ( 1.0 vs 3.2 g/dl , 40 vs 148h , and 3 vs 8 d , respectively ; p < 0.001 for all ) , as well as fewer short-term complications ( 22.5 % vs 42.5 % , p = 0.031 ) .


On intention-to-treat analysis , both the PKEP and OP groups had equivalent Qmax ( 25.27.0 ml/s vs 25.77.6 ml/s , respectively ; p = 0.688 ) , International Prostate Symptom Score ( 3.5 [ 2-5 ] vs 3 [ 2-5 ] , respectively p = 0.755 ) , quality of life ( 2 [ 1-3 ] vs 2 [ 1-3 ] , respectively ; p = 0.950 ) , and postvoid residual urine ( 20 [ 9-33 .5 ] vs 16.5 [ 7-31 ] ml , respectively ; p = 0.469 ) at 72 mo postoperatively .


No patients required reoperation because of recurrence of BPH .


The relatively small sample size is the limitation .


PKEP is a durable procedure with short - to long-term micturition improvement equivalent to OP and significantly lower perioperative morbidity .


We compared PKEP with OP for large prostates and found that PKEP is less invasive , with short - to long-term micturition improvement equivalent to OP .


Plasmakinetic Enucleation of the Prostate and Open Prostatectomy to Treat Large Prostates .


ClinicalTrials.gov identifier NCT01952912 .


http://www.clinicaltrials.gov/ct2/show/NCT01952912?term=NCT016301952912&rank=1 .


To evaluate whether treatment of mild gestational diabetes mellitus ( GDM ) confers sustained offspring health benefits , including a lower frequency of obesity .


Follow-up study of children ( ages 5-10 ) of women enrolled in a multicenter trial of treatment versus no treatment of mild GDM .


Height , weight , blood pressure , waist circumference , fasting glucose , fasting insulin , triglycerides , and HDL cholesterol were measured .


Five hundred of 905 eligible offspring ( 55 % ) were enrolled .


Maternal baseline characteristics were similar between the follow-up treated and untreated groups .


The frequencies of BMI 95th ( 20.8 % and 22.9 % ) and 85th ( 32.6 % and 38.6 % ) percentiles were not significantly different in treated versus untreated offspring ( P = 0.69 and P = 0.26 ) .


No associations were observed for BMI z score , log waist circumference , log triglycerides , HDL cholesterol , blood pressure , or log HOMA-estimated insulin resistance ( HOMA-IR ) .


The effect of treatment was different by sex for fasting glucose and log HOMA-IR ( P for interaction = 0.002 and 0.02 , respectively ) but not by age-group ( 5-6 and 7-10 years ) for any outcomes .


Female offspring of treated women had significantly lower fasting glucose levels .


Although treatment for mild GDM has been associated with neonatal benefits , no reduction in childhood obesity or metabolic dysfunction in the offspring of treated women was found .


However , only female offspring of women treated for mild GDM had lower fasting glucose .


To evaluate the long-term effects of an illicit drug use prevention program for adolescents that integrates life skills into the theory of planned behavior .


We conducted a cluster-randomized trial in which 24 participating schools were randomized to either an intervention group ( 12 schools , n = 1,176 students ) or a control group ( 12schools , n = 915 students ) .


Participants were grade 7 students .


The intervention comprised a main intervention of 10 sessions and two booster interventions .


Booster 1 ( four sessions ) and booster 2 ( two sessions ) were performed at 6months and 12months , respectively , after completion of the main intervention .


Assessments were made at baseline , after the main intervention , and after each booster session using specific questionnaires for measuring participants ' attitudes , subjective norms , perceived behavioral control , and life skills .


Retention rates were 71.9 % ( 845/1 ,176 ) in the intervention group and 90.7 % ( 830/915 ) in the control group after the 12-month follow-up .


A significantly lower proportion of intervention group participants reported illicit drug use after the first and second booster sessions compared with control group participants ( .1 % vs. 1.7 % and .2 % vs. 1.7 % , respectively ; both p < .05 ) .


Attitudes , subjective norms , perceived behavioral control , life skills , and behavioral intention scores of theintervention group were significantly higher than those of control group after the first and second booster sessions ( all p < .001 ) , suggesting that intervention group students tended to avoid drug use .


A drug use prevention program integrating life skills into the theory of planned behavior may be effective for reducing illicit drug use and improving planned behavior-related constructs in adolescents .


To compare the difference of the clinical efficacy in treatment of nervous tinnitus of kidney deficiency between the combined therapy of Zhuang medicine at Qineihuan point combined with the conventional acupuncture and simple conventional acupancture .


Sixty patients were randomized into an observation group and a control group , 30 cases in each one .


In the control group , the conventional acupuncture was applied to Taixi ( KI 3 ) , Zhaohai ( KI 6 ) , Tinggong ( SI 19 ) and Waiguan ( TE 5 ) , etc. and the needles were retained for 30 min .


In the observation group , on the basic treatment as the control group , Zhuang medicine acupuncture at Qineihuan point was added .


The treatment was given once every day , 10 treatments made one session and there were 2 days of interval between the sessions .


In 3 sessions of treatment , the changes of tinnitus were observed and the clinical efficacy was evaluated .


After treatment , tinnitus score and tinnitus grade were all improved as compared with those before treatment in the two groups ( all P < 0.05 ) and the results in the observation group were better than those in the control group ( all P < 0.05 ) .


The curative and remarkably effective rate was 63.3 % ( 19/30 ) and the total effective rate was 93.3 % ( 28/30 ) in the observation group , better than 30.0 % ( 9/30 ) and 73.3 % ( 22/30 ) in the control group ( both P < 0.05 ) .


The combined therapy of Zhuang medicine at Qineihuan point and conventional acupuncture achieves the better efficacy on nervous tinnitus of kidney deficiency as compared with the simple conventional acupuncture .


Presepsin is a soluble fragment of the cluster-of-differentiation marker protein 14 ( CD14 ) involved in pathogen recognition by innate immunity .


We evaluated the relation between its circulating concentration , host response , appropriateness of antibiotic therapy , and mortality in patients with severe sepsis .


Plasma presepsin was measured 1 , 2 , and 7 days after enrollment of 997 patients with severe sepsis or septic shock in the multicenter Albumin Italian Outcome Sepsis ( ALBIOS ) trial .


They were randomized to albumin or crystalloids .


We tested with univariate and adjusted models the association of single measurements of presepsin or changes over time with clinical events , organ dysfunctions , appropriateness of antibiotic therapy , and ICU or 90-day mortality .


Presepsin concentration at baseline ( 946 [ 492-1 ,887 ] ng/L ) increased with the SOFA score , the number of prevalent organ dysfunctions or failures , and the incidence of new failures of the respiratory , coagulation , liver , and kidney systems .


The concentration decreased in ICU over 7 days in patients with negative blood cultures , and in those with positive blood cultures and appropriate antibiotic therapy ; it increased with inappropriate antibiotic therapy ( p = 0.0009 ) .


Baseline presepsin was independently associated with , and correctly reclassified , the risk of ICU and 90-day mortality .


Increasing concentrations of presepsin from day 1 to day 2 predicted higher ICU and 90-day mortality ( adjusted p < 0.0001 and 0.01 , respectively ) .


Albumin had no effect on presepsin concentration .


Presepsin is an early predictor of host response and mortality in septic patients .


Changes in concentrations over time seem to reflect the appropriateness of antibiotic therapy .


The methacholine challenge test quantifies airway hyper-responsiveness , which is measured by the provocative concentration of methacholine causing a 20 % decrease in forced expiration volume in 1 second ( PC20 ) .


The dose-response effect of inhaled corticosteroids ( ICS ) on PC20 has been inconsistent and within-patient variability of PC20 is not well established .


To determine the effect of high - vs low-dose ICS on PC20 and within-patient variability in those with repeated measurements of PC20 .


A randomized , double-masked , crossover trial was conducted in patients with asthma on controller medications with PC20 of 8 mg/mL or lower ( n = 64 ) to evaluate the effect of high-dose ( 1,000 g/d ) vs low-dose ( 250 g/d ) fluticasone for 4 weeks on PC20 .


In addition , the variability of PC20 was assessed in participants who underwent 2 or 3 PC20 measurements on the same dose of ICS ( n = 27 ) over a 4-week interval .


Because there was a significant period effect , dose comparison of the change in PC20 was assessed in the first treatment period .


There was no significant difference in the change in PC20 for high - vs low-dose ICS ( 39 % vs 30 % increase , respectively ; P = .87 ) .


The within - and between-participant variances for log PC20 were 0.84 and 0.96 , respectively , with an intra-class correlation of 0.53 , and 37 % of participants had more than 2 doubling dose changes in PC20 in those with repeated measurements .


The effect of ICS on PC20 is not dose dependent at fluticasone levels of 250 and 1,000 g/d .


Interpersonal variability for PC20 is large .


A lack of precise measurements should be taken into account when interpreting any change in PC20 .


Selenium supplementation for women infected with HIV may increase genital shedding of HIV-1 , however , to our knowledge , no studies have examined the effect on viral shedding in breast milk .


The aim of this study was to determine the effect of selenium supplementation on HIV-1 RNA detection in breast milk of HIV-infected women .


HIV-infected pregnant women enrolled at 12 to 27 wk gestation in a randomized , double-blind , placebo-controlled trial of daily selenium ( 200 g as selenomethionine ) had cell-free HIV-1 RNA quantified in breast milk at 4 to 9 wk postpartum .


All participants received high-dose multivitamins containing vitamin B complex , C , and E as standard of care .


The proportion of women with detectable ( > 50 copies/mL ) HIV-1 RNA in breast milk appeared to be increased in the selenium group ( 36.4 % ) compared with those in the placebo group ( 27.5 % ) among the total cohort ( N = 420 ) , but results were borderline statistically significant ( relative risk [ RR ] , 1.32 ; 95 % confidence interval [ CI ] , 1.00-1 .76 ; P = 0.05 ) .


In secondary analyses , the proportion of women with detectable HIV-1 RNA in breast milk was significantly greater in the selenium group ( 37.8 % ) compared with placebo group ( 27.5 % ) among women who did not receive highly active antiretroviral therapy ( HAART ; RR , 1.37 ; 95 % CI , 1.03-1 .82 ; P = 0.03 ) .


This relationship was primarily due to a significant effect of selenium among primiparous women ( RR , 2.24 ; 95 % CI , 1.30-3 .86 ; P < 0.01 ) , but not multiparous women ( RR , 1.14 ; 95 % CI , 0.81-1 .59 ; P = 0.54 ) ( P-value for interaction = 0.02 ) .


Too few women received HAART in this study ( n = 12 ) to establish the effect of selenium supplementation .


Selenium supplementation appears to increase HIV-1 RNA detection in breast milk among primiparous women not receiving HAART .


Safety studies among pregnant women on HAART need to be conducted before administering selenium-containing supplements .


Published studies have reported conflicting results regarding the effects of cinnamon on glucose , lipids and insulin .


To gain further insight into the metabolic effects of Cinnamomum cassia we performed randomized , double-blinded placebo-controlled study using euglycaemic-hyperinsulinaemic clamp .


Twenty-one subjects with impaired glucose tolerance ( IGT ) were included in the study ( 10 or 11 subjects in each group ) .


The study groups were matched for age , gender and body mass index ( BMI ) .


Waist-to-hip ratio , BMI , blood pressure , fasting blood glucose , insulin , triglycerides , total cholesterol , low-density lipoprotein , high-density lipoprotein , HbA1c , ASAT , ALAT , bilirubin , ALP , GT and PK were measured before and after the intake of capsules equivalent to 6 g cinnamon twice a day for 12 weeks .


The changes in insulin resistance were measured by euglycaemic-hyperinsulinaemic clamp .


The Wilcoxon signed rank sum test , the Mann-Whitney U test and Pearson 's chi-squared test were used to analyse the data .


Values of p < 0.05 were considered to indicate statistically significant differences .


At enrolment , the groups were similar in terms of age , gender and BMI .


Of the 21 randomized patients with IGT , 17 completed the study ( 8 controls vs. 9 treated ) .


The ingestion of 6 g cinnamon twice a day for 12 weeks had no significant effect on insulin sensitivity , HbA1c , fasting glucose or BMI .


No significant changes were seen in lipids or liver enzymes .


This study showed that ingestion of 6 g C. cassia twice a day for 12 weeks did not change the insulin sensitivity or liver enzymes in subjects with IGT .


Up to 30 % of patients suffer from long-term functional restrictions following conservative treatment of distal radius fractures .


Whether duration of cast immobilisation influences functional outcome remains unclear .


The aim of the study is to evaluate whether the duration of immobilization of non or minimally displaced distal radial fractures can be safely reduced .


We will compare three weeks of plaster cast immobilization with five weeks of plaster cast immobilization in adult patient with non or minimally displaced distal radial fractures .


a prospective randomized clinical trial .


adult ( > 18 years ) ( independent in activities of daily living ) patients with a non/minimal displaced distal radius fracture ( dorsal angulation < 15 , volar tilt < 20 , radial inclination > 15 , ulnar positive variance < 5 mm and an articular step off < 2 mm ) .


three weeks of plaster cast immobilization versus five weeks of plaster cast immobilization.Main study parameters : primary outcome parameters : Patient related wrist evaluation ( PRWE ) Quick Disability of Arm , Shoulder and Hand ( QUICKDASH ) score after a one year follow-up , and secondary parameters : range of motion , pain level ( VAS ) and complications .


The expectation of this study is that shorter duration of plaster cast immobilisation is beneficial for the patient with a distal radius fracture .


This risk of specific complications is low and generally similar in both treatment options .


Moreover , the burden of the study is not much higher compared to standard treatment .


Follow-up is standardized according to current trauma guidelines .


Literature indicates that both treatment options from the study are accepted for displaced distal radius fractures .


No clear advantage for one treatment options is found at present in the literature , although there is no level I evidence present .


This trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two treatment options for non-displaced distal radial fractures .


The gathered data may support the development of a clinical guideline for conservative treatment of distal radial fractures .


Netherlands National Trial Register NTR3552 .


The event-free survival of childhood acute lymphoblastic leukemia ( ALL ) has been reported to be superior when oral methotrexate ( MTX ) and 6-mercaptopurine ( 6MP ) maintenance therapy ( MT ) is administered in the evening compared to the morning .


In the ALL92 MT study we prospectively registered the intake of MTX/6MP .


The registration was done when blood samples for erythrocyte MTX/6MP metabolite measurements were collected , and referred to the time of intake in the period since last registration .


Nine thousand one hundred ninety-five registrations in total .


The administration of MTX/6MP was scored as morning , midday , or evening .


Of 532 patients , 296 took their medication consistently in the evening , 129 in the evening 50.0-99 .9 % of the time , and 101 in the evening < 50 % of the time , six did not have any registrations .


The circadian schedule did not differ significantly by age , sex , MTX/6MP doses , and average absolute neutrophil counts .


The circadian schedule groups did differ on risk groups ( P = 0.003 ) with fewer HR patients in the 50-99 .9 % group , and there was a negative correlation between percentage of time on evening schedule and average WBC ( Spearman 's rho -0.15 ; P = 0.0004 ) .


Average WBC was not associated with relapse on ALL92 .


In a Cox multivariate model the circadian schedule of MTX/6MP was not of prognostic significance for the risk of relapse , and the 10-year cumulative relapse risk was below 20 % in all groups .


An evening schedule may still be recommended based on the previous publications , but in this study morning administration of MTX and 6MP does not seem to impact EFS .


To quantify plasma concentrations and determine adverse ocular , renal , or hepatic effects associated with repeated topical ophthalmic application of 0.1 % diclofenac to healthy cats .


8 healthy sexually intact male cats .


A randomized , placebo-controlled crossover study was conducted .


A topical formulation of 0.1 % diclofenac was administered 4 times/d for 7 days to 4 cats , and artificial tear ( control ) solution was administered to the other 4 cats .


After a 12-day washout period , cats received the other treatment .


Ophthalmic examinations were performed daily .


Plasma samples were obtained on days 1 and 7 for pharmacokinetic analysis .


A CBC , serum biochemical analysis , urinalysis , determination of urine protein-to-creatinine ratio , and determination of glomerular filtration rate were performed before the start of the study and after each 7-day treatment period .


Mild conjunctival hyperemia was the only adverse ocular effect detected .


Maximal drug concentration and area under the curve were significantly higher on day 7 than on day 1 .


Diclofenac-treated cats had a significantly lower glomerular filtration rate than did control-treated cats after the second but not after the first treatment period , presumably associated with iatrogenic hypovolemia .


Topical ophthalmic administration of 0.1 % diclofenac was well tolerated in healthy cats , with only mild signs of ocular irritation .


Detectable systemic concentrations of diclofenac were achieved with accumulation over 7 days .


Systemic absorption of diclofenac may be associated with reduced glomerular filtration rate , particularly in volume-contracted animals .


Topical ophthalmic 0.1 % diclofenac should be used with caution in volume-contracted or systemically ill cats .


Mild primary hyperparathyroidism ( PHPT ) is a common disease especially in middle-aged and elderly women .


The diagnosis is frequently made incidentally and treatment strategies are widely discussed .


To study the effect of parathyroidectomy ( PTX ) compared with observation ( OBS ) on biochemistry , safety , bone mineral density ( BMD ) , and new fractures .


Prospective , randomized controlled study ( SIPH study ) , with a 5-year follow-up .


The study was conducted at multicenter , tertiary referral centers .


Of 191 randomized patients with mild PHPT , biochemical data were available for 145 patients after 5 years , with a mean age at inclusion of 62.8 years ( OBS group , 9 males ) and 62.1 years ( PTX group , 10 males ) .


Parathyroidectomy vs observation .


Biochemistry , BMD , and new radiographic vertebral fractures .


Serum-calcium and PTH-levels normalized after surgery and did not deteriorate by observation .


BMD Z-scores were normal at inclusion in the lumbar spine ( LS ) and femoral neck ( FN ) .


For LS , BMD Z-scores were stable for 5 years with observation , but decreased in FN ( P < .02 ) .


After surgery , BMD Z-scores increased significantly in both compartments ( P < .02 for both ) , with a highly significant treatment effect of surgery compared to observation ( P < .001 ) .


During follow-up , five new clinically unrecognized vertebral fractures were found in 5 females , all in the OBS group ( P = .058 ) .


Even though new vertebral fractures occurred only in the observation group , the frequency was not significantly different from the surgery group .


Longer follow-up is needed before firm conclusions can be drawn about the long-term safety of observation , as opposed to surgery .


The purpose of this multicenter randomly controlled clinical trial was to compare two acellular dermal matrix ( ADM ) materials produced by different processing techniques , freeze-dried ( FDADM ) and solvent-dehydrated ( SDADM ) ADM , in their ability to correct Miller Class I and II recession defects .


Eighty individuals from four study centers , each with a single maxillary anterior Miller Class I or II recession defect were enrolled .


Participants were randomly assigned and treated with coronally advanced flap ( CAF ) + FDADM ( n = 42 ) or CAF + SDADM ( n = 38 ) .


Gingival thickness , recession depth , recession width , probing depth ( PD ) , clinical attachment level , gingival index , plaque index , patient discomfort , and wound healing index were recorded before surgery ( day 0 ) , immediately after surgery ( day 1 ) , and 2 , 4 , 12 , 24 , and 52 weeks postoperatively .


The Student t test , paired t test , and Kruskal-Wallis one-way ANOVA were used to analyze the data .


When evaluating the clinical parameters after 1 year , both groups showed significant ( P < 0.05 ) improvement for most of the parameters evaluated when compared to baseline ( day 0 ) .


For example , percentage of root coverage was 77.21 % 29.10 % for CAF + FDADM and 71.01 % 32.87 % for CAF + SDADM .


Conversely , no significant differences were observed between the two materials for any clinical parameter tested or for patient satisfaction except PD on the mesial side of the defects ( P = 0.03 ) .


Both FDADM and SDADM can be used successfully to correct Miller Class I or II recession defects .


There were no statistically significant differences between groups for any of the clinical parameters tested .


Total Hip Arthroplasty ( THA ) is being used more commonly in younger higher demand patients .


The purpose of this randomized pilot study was to explore a ) feasibility of comprehensive postoperative rehabilitation compared to usual care following primary THA in subjects < 65 years , b ) appropriate outcome measures including performance-based measures and c ) timing of assessments .


21 subjects who underwent primary THA were randomized to receive a three-month out-patient rehabilitation program ( Intervention ) or usual postoperative care ( Control ) .


Subjects were assessed preoperatively , six-weeks postoperatively ( Pre-intervention ) and four and 12 months postoperatively ( Post-intervention ) .


Self-report measures were the Western Ontario McMaster Osteoarthritis Index ( WOMAC ) and Rand 36-Item Health Survey ( RAND-36 ) .


Performance-based measures included lower extremity strength , walking speed and endurance , and gait laboratory assessment .


Ten Control and 11 Intervention subjects with an average age of 53.4 ( SD9 .3 ) years were randomized .


All Intervention subjects completed the program without adverse effects .


Although no statistically significantly results were reported , four months postoperatively , Intervention subjects had clinically important differences ( CID ) in strength compared with Control subjects .


Walking endurance , WOMAC and RAND scores improved significantly with no CID noted between groups .


Ten ( 48 % ) subjects reported a ceiling effect on the WOMAC ( 9 ( 43 % ) subjects on Pain ; 1 ( 5 % ) subject on Function ) .


No group CID were noted in gait measures .


Our recommendations would be that performance-based strength measures should be considered for the primary outcome in this younger cohort .


Because of the ceiling effects with WOMAC Pain , a different pain measure is indicated .


Other more challenging functional performance-based tests should be considered such as a more prolonged endurance test .


There is merit in one-year follow-up as strength improved after four months in both groups .


Long-term complications of cystic fibrosis include osteoporosis and fragility fractures , but few data are available about effective treatment strategies , especially in young patients .


We investigated treatment of low bone mineral density in children , adolescents , and young adults with cystic fibrosis .


We did a multicentre trial in two phases .


We enrolled patients aged 5-30 years with cystic fibrosis and low bone mineral density , from ten cystic fibrosis regional centres in Italy .


The first phase was an open-label , 12-month observational study of the effect of adequate calcium intake plus calcifediol .


The second phase was a 12-month , double-blind , randomised , placebo-controlled , parallel group study of the efficacy and safety of oral alendronate in patients whose bone mineral apparent density had not increased by 5 % or more by the end of the observational phase .


Patients were randomly assigned to either alendronate or placebo .


Both patients and investigators were masked to treatment assignment .


We used dual x-ray absorptiometry at baseline and every 6 months thereafter , corrected for body size , to assess lumbar spine bone mineral apparent density .


We assessed bone turnover markers and other laboratory parameters every 3-6 months .


The primary endpoint was mean increase of lumbar spine bone mineral apparent density , assessed in the intention-to-treat population .


This study is registered with ClinicalTrials.gov , number NCT01812551 .


We screened 540 patients and enrolled 171 ( mean age 138 years , SD 59 , range 5-30 ) .


In the observational phase , treatment with calcium and calcifediol increased bone mineral apparent density by 5 % or more in 43 patients ( 25 % ) .


128 patients entered the randomised phase .


Bone mineral apparent density increased by 163 % in the alendronate group ( n = 65 ) versus 31 % in the placebo group ( n = 63 ; p = 00010 ) .


19 of 57 young people ( 333 % ) receiving alendronate attained a normal-for-age bone mineral apparent density Z score .


In the observational phase , five patients had moderate episodes of hypercalciuria , which resolved after short interruption of calcifediol treatment .


During the randomised phase , one patient taking alendronate had mild fever versus none in the placebo group ; treatment groups did not differ significantly for other adverse events .


Correct calcium intake plus calcifediol can improve bone mineral density in some young patients with cystic fibrosis .


In those who do not respond to calcium and calcifediol alone , alendronate can safely and effectively increase bone mineral density .


Telethon Foundation ( Italy ) .


The optimal crystalloid solution to use perioperatively in patients undergoing open radical cystectomy remains unclear .


Many of the fluids used for intravenous hydration contain supraphysiologic concentrations of chloride , which can induce hyperchloremia and metabolic acidosis , resulting in renal vasoconstriction and decreased renal function .


In addition , patients receiving less fluid and less sodium show faster recovery of gastrointestinal ( GI ) function after colonic surgery .


This is an investigator-initiated , single-center , randomized , controlled , parallel group trial with assessor-blinded outcome assessment , in the Department of Urology , University Hospital Bern , Switzerland .


The study will involve 44 patients with bladder cancer scheduled for radical cystectomy and urinary diversion .


The primary outcome is the duration between the end of surgery and the return of the GI function ( first defecation ) .


Secondary outcomes are fluid balance ( body weight difference postoperatively versus preoperatively ) and the incidence of kidney function disorders according to the Risk-Injury-Failure-Loss-End Stage Renal Disease ( RIFLE classification ) .


An equal number of patients are allocated to receive Ringerfundin solution or a glucose/potassium-based balanced crystalloid solution as baseline infusion during the entire time that intravenous administration of fluid is necessary during the perioperative period .


The randomized crystalloid solution is infused at a rate of 1 ml/kg/h until the bladder has been removed , followed by 3 ml/kg/h until the end of surgery .


Postoperative hydration is identical in both groups and consists of 1,500 ml of the randomized crystalloid solution per 24 hours .


Postoperative patient care is identical in both groups ; patients are allowed to drink clear fluids immediately after surgery , and liquid diet is started on postoperative day 1 , as well as active mobilization and the use of chewing gum .


Body weight is measured daily in the morning .


Time of first flatus and first defecation are recorded .


This trial assesses the benefits and harms of two different balanced crystalloid solutions for perioperative fluid management in patients undergoing open radical cystectomy with urinary diversion , with regard to return of GI function and effects on postoperative renal function .


Current Controlled Trials ISRCTN32976792 ( registered on November 21 2013 ) .


Tubal factor accounts for 25-30 % of cases of female infertility .


Laparoscopy `` Gold Standard '' for tubal evaluation .


However , it is known that during the initial infection of the fallopian tube mucosal damage occurs , a condition which plays a decisive role in reproduction .


In this prospective randomized study , 468 infertile women with evidence of fallopian tube disease were included .


In this , for 256 patients ( group 1 ) after laparoscopic salpingolysis , salpingostomy we performed an additional step operation transcervical falloposcopy tubal dilatation ( TFTD ) .


212 patients ( group 2 ) produced only laparoscopic salpingolysis , salpingostomy .


As a result , TFTD patency of the fallopian tubes for coaxial catheter was restored in 50 ( 78 % ) of 64 tubes with bilateral total occlusion , in 238 ( 93 % ) of 254 with partial occlusion of the bilateral , in 14 ( 58 % ) of 24 total unilateral occlusion and 26 ( 92 % ) of 28 with partial unilateral occlusion .


Total number of pregnancies for one year in the first group of patients was 152 ( 59.3 % ) , in the second 57 ( 27.1 % ) , of which in the first group 147 - intrauterine pregnancies ( 57.4 % ) and in the second - 46 ( 21.7 % ) .


Falloposcopy surgeon provides good opportunities for the diagnosis and treatment of intralumen lesions .


Significant increase in the frequency of uterine pregnancy in the case of an additional step - TFTD during salpingolysis , salpingostomy in patients with tubal factor infertility .


To determine clinical and demographic characteristics associated with antimuscarinic treatment response using a regression model .


Adults with overactive bladder ( OAB ) symptoms for > 3 months and 1 urgency urinary incontinence ( UUI ) episode and 8 micturitions per 24 hours at baseline were randomized to fesoterodine ( 8 mg ) , tolterodine extended-release ( 4 mg ) , or placebo in two 12-week , double-blind , head-to-head studies .


Fesoterodine-treated patients received 4 mg/d during the first week and 8 mg/d thereafter .


Patients completed 3-day bladder diaries and the Overactive Bladder Questionnaire at baseline and week 12 .


Pooled data for changes from baseline to week 12 in winsorized UUI episodes , micturitions , and urgency episodes per 24 hours and Overactive Bladder Questionnaire Symptom Bother and health-related quality of life scores were analyzed posthoc using a regression model that selects outcome predictors from baseline values and patient characteristics while retaining baseline values and treatment , with stepwise inclusion of significant covariates and assessment of treatment interactions .


Logistic regression was used for analysis of diary-dry rates .


Younger age , lack of previous antimuscarinic treatment , shorter duration of OAB diagnosis , and female gender were common predictors of larger changes in outcomes from baseline to week 12 .


Baseline measures often interacted with treatment , such that poorer baseline outcomes were predictive of larger treatment differences .


Longer duration since OAB diagnosis predicted greater treatment differences for UUI episodes and in diary-dry rate , and increased age predicted greater treatment differences for micturitions .


Symptom severity and duration , age , gender , and previous antimuscarinic pharmacotherapy impact the response to antimuscarinic treatment .


To compare long-term functional and radiological outcome following microfracture technique ( MF ) versus osteochondral autologous transplantation ( OAT ) mosaicplasty for treating focal chondral lesions of the knee .


Twenty-five patients ( mean age 32.3 years , SD 7.7 ) with a full-thickness ( International Cartilage Repair Society grade 3 or 4 ) chondral lesion of the articulating surface of the femur were randomized to either MF ( n = 11 ) or OAT mosaicplasty ( n = 14 ) .


At a median follow-up of 9.8 years ( range 4.9-11 .4 ) , the patients were evaluated using Lysholm score ( n = 25 ) , Knee Injury and Osteoarthritis Outcome Score ( KOOS , n = 25 ) , isokinetic quadriceps measurement and hamstring strength measurement ( n = 22 ) and standing radiographs ( n = 23 ) .


There were no significant differences in Lysholm score , KOOS , isokinetic muscle strength or radiographic osteoarthritis between MF-treated patients and OAT mosaicplasty-treated patients at follow-up .


Mean Lysholm score at follow-up was 69.7 [ 95 % confidence interval ( CI ) , 55.1-84 .4 ] for the MF group and 62.6 ( 95 % CI , 52.6-72 .6 ) for the OAT mosaicplasty group .


At long-term follow-up , there were no significant differences between patients treated with MF and patients treated with OAT mosaicplasty in patient-reported outcomes , muscle strength or radiological outcome .


Therapeutic study , Level II .


Studies suggest that smokers present more or greater numbers of potential periodontal pathogens than non-smokers .


The aim of this study was to investigate the microbiologic effects of adjunctive aPDT on nonsurgical periodontal treatment in smokers with chronic periodontitis ( CP ) .


Twenty smokers with CP had two contralateral teeth randomly assigned in a split-mouth design to receive SRP ( CG ) or SRP + a single episode of aPDT ( TG ) , with a diode laser and a phenothiazine photosensitizer .


Levels of 40 subgingival species were measured using checkerboard DNA-DNA hybridization at baseline and 1 , 4 and 12 weeks after periodontal treatment .


All 40 bacterial species evaluated were detected in different levels at baseline , with no statistic significant differences between groups .


After periodontal treatment , the levels of some bacterial species decreased , while some other species presented an increase .


Despite this variation , the statistical analysis was not able to identify significant differences neither at intragroup nor at intergroup comparisons .


Periodontal treatment with SRP or SRP + aPDT was not able to reduce levels of 40 subgingival species in smokers with CP .


These outcomes indicate that smoking impairs periodontal healing after nonsurgical treatment even associated with aPDT .


To evaluate whether patients with rheumatoid arthritis who did not respond sufficiently to tocilizumab ( TCZ ) plus disease-modifying antirheumatic drug ( DMARD ) treatment by Week 8 responded at later timepoints when continuing to take their original dose of TCZ .


In this posthoc analysis of data from phase III randomized controlled trials of inadequate responders ( IR ) to DMARD or tumor necrosis factor - inhibitors ( anti-TNF ) , percentages of patients meeting early response criteria were calculated by randomized treatment arm ( TCZ 4 mg/kg , 8 mg/kg , or placebo in combination with DMARD ) .


Percentages of patients achieving certain disease activity thresholds at later timepoints were calculated for patients who had/had not achieved response by Week 8 .


In DMARD-IR early nonresponders , 29.0 % , 17.2 % , and 3.7 % of TCZ 8 mg/kg-randomized , TCZ 4 mg/kg-randomized , and placebo-randomized patients , respectively , achieved 28-joint Disease Activity Score ( DAS28 ) 3.2 by Week 24 .


Among anti-TNF-IR patients without early response , 26.5 % , 8.5 % , and 1.9 % of TCZ 8 mg/kg-randomized , TCZ 4 mg/kg-randomized , and placebo-randomized patients , respectively , achieved DAS28 3.2 at Week 24 .


A substantial number of DMARD-IR patients taking TCZ 4 or 8 mg/kg and anti-TNF-IR patients taking TCZ 8 mg/kg who failed to respond by 8 weeks benefited from continued TCZ treatment in combination with DMARD .


In contrast , the anti-TNF-IR patients without early responses who continued to take TCZ 4 mg/kg were unlikely to experience a cumulative benefit .


ClinicalTrials.gov registration numbers : NCT00106548 , NCT00106574 , NCT00106535 , NCT00106522 .


The objective of this study was to assess the safety , tolerability , pharmacokinetics , and pharmacodynamics of selexipag , an orally available selective prostacyclin receptor agonist , in development for pulmonary arterial hypertension in healthy subjects .


This was a double-blind , placebo-controlled , randomised , multiple-ascending-dose , up-titration study .


Male subjects received increasing oral doses of selexipag ( 400-1 ,800 g ; n = 12 ) or placebo ( n = 4 ) twice daily for 3 days each , using incremental steps of 200 g between each dose level .


Standard safety and tolerability data were collected .


Blood samples were taken to assess the pharmacokinetics of selexipag and its active metabolite ACT-333679 and possible effects on platelet aggregation .


Dose levels of selexipag up to 1,600 g were well tolerated and this dose was identified as the maximum tolerated dose .


Plasma exposure to ACT-333679 was approximately 4 times higher than that to selexipag .


Steady-state conditions for both compounds were reached on day 3 of each dose level , and no accumulation of selexipag or ACT-333679 was observed .


Based on the area under the curve and the maximum plasma concentration , the pharmacokinetics of selexipag and ACT-333679 were dose proportional .


At the highest dose level , the geometric mean terminal half-life of selexipag and ACT-333679 was 1.4 and 8.7 h , respectively .


The observed effects on platelet aggregation were variable without obvious drug - or dose-dependent pattern .


Oral administration of increasing doses of selexipag was well tolerated .


The present results support the conduct of future clinical trials .


The objective of this study was to compare the costs and outcomes of two sexually transmitted infection ( STI ) screening interventions targeted at men in football club settings in England , including screening promoted by team captains .


A comparison of costs and outcomes was undertaken alongside a pilot cluster randomised control trial involving three trial arms : ( 1 ) captain-led and poster STI screening promotion ; ( 2 ) sexual health advisor-led and poster STI screening promotion and ( 3 ) poster-only STI screening promotion ( control/comparator ) .


For all study arms , resource use and cost data were collected prospectively .


There was considerable variation in uptake rates between clubs , but results were broadly comparable across study arms with 50 % of men accepting the screening offer in the captain-led arm , 67 % in the sexual health advisor-led arm and 61 % in the poster-only control arm .


The overall costs associated with the intervention arms were similar .


The average cost per player tested was comparable , with the average cost per player tested for the captain-led promotion estimated to be 88.99 compared with 88.33 for the sexual health advisor-led promotion and 81.87 for the poster-only ( control ) arm .


Costs and outcomes were similar across intervention arms .


The target sample size was not achieved , and we found a greater than anticipated variability between clubs in the acceptability of screening , which limited our ability to estimate acceptability for intervention arms .


Further evidence is needed about the public health benefits associated with screening interventions in non-clinical settings so that their cost-effectiveness can be fully evaluated .


To explore the regulatory effects of established Chinese herbal formulas on inflammatory mediators released during asthma attacks , and to elucidate the molecular mechanism of Traditional Chinese Medicine in the treatment of asthma .


Seventy-five asthmatic children were randomly divided into a Chinese medication group ( 45 cases ) and a Western medication control group ( 30 cases ) .


Patients in the Chinese medication group were treated with a series of established Chinese herbal formulas , whereas the Western medication control group received a leukotriene receptor antagonist and a bronchial relaxant .


Real-time PCR was used to determine the mRNA expression levels of interleukin ( IL ) -4 , cysteinyl leukotriene receptor 1 ( CysLTR1 ) , and interferon ( IFN ) - gamma in peripheral blood mononuclear cells before and after treatment .


Enzyme-linked immunosorbent assay was used to measure the peripheral blood levels of IL-4 , leukotriene ( LTE ) -4 , and INF-gamma before and after treatment .


After treatment , the mRNA expression levels of IL-4 and CysLTR1 were down-regulated ( P < 0.01 ) and the mRNA expression levels of IFN-gamma were up-regulated ( P < 0.05 ) in the Chinese medication and Western medication groups ; no significant difference was found between the two groups .


In the Chinese medication group , IL-4 blood level was decreased and it was significantly different from that in the Western medication group ( P < 0.05 ) ; there was also a significant increase in IFN-gamma blood levels after treatment with Chinese medication ( P < 0.05 ) .


There were no significant differences in LTE-4 blood levels between the two groups before and after treatment ( P > 0.05 ) .


Chinese medication has a regulatory effect on leukotriene receptor gene expression and the imbalance of Th1/Th2 immune cells during asthma attacks in pediatric patients .


To determine inter-rater reliability in identifying a knee extension lag using the sitting active and prone passive lag test ( SAPLT ) .


56 patients with a diagnosis of knee pain were randomly assigned and independently examined by two physical therapists at a time , to determine the presence of an active or a passive extension lag at the knee .


An active lag was determined by the inability of the erectly seated subject to actively extend the involved knee in maximal dorsiflexion of the ankle to the same level as the normal knee held in maximal extension and ankle in maximal dorsiflexion , as seen by the levels of the toes .


A passive lag was determined by placing the subject prone with the knees just past the edge of the table and determining the high position of the heel in a fully resting extension position compared to the heel on the normal side .


For the sitting active lag test , the inter-rater reliability was ` good ' ( Kappa 0.792 , SE of kappa 0.115 , 95 % confidence interval ) .


For the prone passive lag test , the inter-rater reliability was ` good ' ( Kappa 0.636 , SE of kappa 0.136 , 95 % confidence interval ) .


The SAPLT may be incorporated as a simple yet effective test to determine the presence of a knee extension lag .


It identifies the type of restraint , active , passive or both , and is suggestive of the most appropriate management .


In a large cluster-randomized trial on the impact of a prediction model , presenting the calculated risk of postoperative nausea and vomiting ( PONV ) on-screen ( assistive approach ) increased the administration of risk-dependent PONV prophylaxis by anaesthetists .


This change in therapeutic decision-making did not improve the patient outcome ; that is , the incidence of PONV .


The present study aimed to quantify the effects of adding a specific therapeutic recommendation to the predicted risk ( directive approach ) on PONV prophylaxis decision-making and the incidence of PONV .


A prospective before-after study was conducted in 1483 elective surgical inpatients .


The before-period included care-as-usual and the after-period included the directive risk-based ( intervention ) strategy .


Risk-dependent effects on the administered number of prophylactic antiemetics and incidence of PONV were analysed by mixed-effects regression analysis .


During the intervention period anaesthetists administered 0.5 [ 95 % confidence intervals ( CIs ) : 0.4-0 .6 ] more antiemetics for patients identified as being at greater risk of PONV .


This directive approach led to a reduction in PONV [ odds ratio ( OR ) : 0.60 , 95 % CI : 0.43-0 .83 ] , with an even greater reduction in PONV in high-risk patients ( OR : 0.45 , 95 % CI : 0.28-0 .72 ) .


Anaesthetists administered more prophylactic antiemetics when a directive approach was used for risk-tailored intervention compared with care-as-usual .


In contrast to the previously studied assistive approach , the increase in PONV prophylaxis now resulted in a lower PONV incidence , particularly in high-risk patients .


When one aims for a truly ` PONV-free hospital ' , a more liberal use of prophylactic antiemetics must be accepted and lower-risk thresholds should be set for the actionable recommendations .


Several field triage systems have been developed to rapidly sort patients following a mass casualty incident ( MCI ) .


JumpSTART ( Simple Triage and Rapid Transport ) is a pediatric-specific MCI triage system .


SALT ( Sort , Assess , Lifesaving interventions , Treat/Transport ) has been proposed as a new national standard for MCI triage for both adult and pediatric patients , but it has not been tested in a pediatric population .


This pilot study hypothesizes that SALT is at least as good as JumpSTART in triage accuracy , speed , and ease of use in a simulated pediatric MCI .


Paramedics were invited and randomly assigned to either SALT or JumpSTART study groups .


Following randomization , subjects viewed a 15-minute PowerPoint lecture on either JumpSTART or SALT .


Subjects were provided with a triage algorithm card for reference and were asked to assign triage categories to 10 pediatric patients in a simulated building collapse .


The scenario consisted of 4 children in moulage and 6 high-fidelity pediatric simulators .


Injuries and triage categories were based on a previously published MCI scenario .


One investigator followed each subject to record time and triage assignment .


All subjects completed a post-test survey and structured interview following the simulated disaster .


Forty-three paramedics were enrolled .


Seventeen were assigned to the SALT group with an overall triage accuracy of 66 % 15 % , an overtriage mean rate of 22 16 % , and an undertriage rate of 10 9 % .


Twenty-six participants were assigned to the JumpSTART group with an overall accuracy of 66 12 % , an overtriage mean of 23 16 % , and an undertriage rate of 11.2 11 % .


Ease of use was not statistically different between the two systems ( median Likert value of both systems = 2 , p = 0.39 ) Time to triage per patient was statistically faster in the JumpSTART group ( SALT = 34 23 seconds , JumpSTART = 26 19 seconds , p = 0.02 ) .


Both systems were prone to cognitive and affective error .


SALT appears to be at least as good as JumpSTART in overall triage accuracy , overtriage , or undertriage rates in a simulated pediatric MCI .


Both systems were considered easy to use .


However , JumpSTART was 8 seconds faster per patient in time taken to assign triage designations .


To explore the clinical efficacy and effect mechanism on chronic urticaria treated with moving cupping therapy combined with autohemotherapy with acupaint injection for desensitization at acupoints .


One hundred and four patients of chronic urticaria were randomized into a comprehensive therapy group and a medication group , 52 cases in each one .


In the comprehensive therapy group , the moving cupping therapy along the governor vessel and bladder meridian of foot-taiyang was applied combined with autohemotherapy with acupaint injection for desensitization at acupoints .


The self-venous blood was injected at bilateral Quchi ( LI 11 ) and Zusanli ( ST 36 ) , 1 mL at each acupoint , once every 3 days .


In the medication group , cetirizine tablets , 10 mg were prescribed for oral administration , once every day , and the compound dexamethasone acetate cream was used externally , once to twice a day .


The clinical efficacy : was observed in 30 days of treatment in the two groups .


The changes of serum interleukin 4 ( IL-4 ) and immunoglobulin E ( Ig E ) before and after treatment were observed .


The recurrence rate was compared between the two groups in 3 months after treatment .


The cured and markedly effective rate was 90.4 % ( 47/52 ) in the comprehensive therapy group , which was higher obviously than 78.8 % ( 41/52 , P < 0.05 ) in the medication group .


The levels of serum IL-4 and IgE were reduced in the patients of the two groups , indicating the significant difference in comparison before and after treatment ( all P < 0.01 ) and the reducing degree in the comprehensive therapy group was much more significant than that in the medicine group ( both P < 0.01 ) .


The recurrence rate was 19.1 % ( 9/47 ) in the comprehensive therapy group in the 3-month follow-up after treatment , and apparently lower than 51.2 % ( 21/41 , P < 0.01 ) .


The moving cupping therapy combined with autohemotherapy with acupaint injection for desensitization at acupoints achieves the better efficacy on chronic urticaria compared with the routine western medicine treatment and the recurrence rate is low .


The effect mechanism is possibly related to the down-regulation of serum IL-4 and IgE in the patients .


To investigate the education effect of case-based learning ( CBL ) pattern on clinical internship of conservative dentistry and endodontics .


Forty-one undergraduates were randomly assigned into CBL group and traditional teaching group .


After clinical internship in the department of conservative dentistry and endodontics for 11 weeks , each student in the 2 groups underwent comprehensive examinations including medical record writing , case analysis , academic knowledge , professional skills and the ability of winning the trust of the patients .


The scores were compared between the 2 groups using SPSS 13.0 software package .


There was no significant difference between the 2 groups with regard to the scores of academic knowledge and profession skills ( P > 0.05 ) .


However , the results of medical record writing , case analysis and the ability of winning the trust of the patients showed significant difference between the 2 groups ( P < 0.05 ) .


Proper application of CBL in clinical internship of conservative dentistry and endodontics contributes to improve students ' ability of clinical thinking , synthetical analysis and adaptability to different patients .


People with dementia living in care homes often have complex mental health problems , disabilities and social needs .


Providing more comprehensive training for staff working in care home environments is a high national priority .


It is important that this training is evidence based and delivers improvement for people with dementia residing in these environments .


Well-being and Health for People with Dementia ( WHELD ) combines the most effective elements of existing approaches to develop a comprehensive but practical staff training intervention .


This optimised intervention is based on a factorial study and qualitative evaluation , to combine : training on person-centred care , promoting person-centred activities and interactions , and providing care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes .


The trial will be a randomised controlled two-arm cluster single blind trial that will take place for nine months across 80 care homes in the United Kingdom .


The overarching goal of this trial is to determine whether this optimised WHELD intervention is more effective in improving the quality of life and mental health than the usual care provided to people with dementia living in nursing homes .


This study will be the largest and best powered randomised controlled trial ( RCT ) evaluating the benefits of an augmented person-centred care training intervention in care homes worldwide .


Current controlled trials ISRCTN62237498 Date registered : 5 September 2013 .


To observe the clinical effect of slow-rapid reinforcing-reducing needling manipulation at Jiaji ( EX-B 2 ) acupoint for lumbar intervertebral disc protrusion .


Sixty subjects met the inclusion criteria of disc herniation were randomly divided into treatment group ( n = 30 ) and control group ( n = 30 ) .


In the treatment group , the stimulation mode ( slow or fast , reinforcement or reduction ) of Jiaji acupoints ( EX-B 2 ) was based on the status of the patients by an overall analysis of symptoms and signs .


Other acupoints such as Huantiao ( GB 30 ) , Weizhong ( BL 40 ) , etc. were stimulated with uniform reinforcing-reducing manipulation .


In the control group , all the acupoints were stimulated in uniform reinforcing-reducing mode .


The treatment was conducted once a day , continuously for 18 days with 1 day 's break between every 6 days .


The clinical efficacy appraisal , visual analogue scale ( VAS ) and Japanese orthopaedic association ( JOA ) scores and traditional Chinese medicine ( TCM ) syndrome scores were used for outcome assessment .


In comparison with pretreatment , the VAS scores and TCM syndrome scores were significantly decreased in both control and treatment groups ( P < 0.05 ) , and the JOA scores were markedly increased after the treatment ( P < 0.05 ) .


The therapeutic effects of the treatment group were obviously superior to those of the control group in down-regulating the VAS score and TCM syndome score and up-regulating JOA score ( P < 0.05 ) .


Slow-fast reinforcing-reducing needling manipulation is superior to the routine acupuncture in the management of lumbar intervertebral disc protrusion .


There are limited clinical experiments addressing the effects of photodynamic therapy ( PDT ) as an adjunct to conventional scaling and root planing ( SRP ) on clinical and biologic features of periodontitis .


This trial compares the clinical parameters and cytokine profiles in gingival crevicular fluid of patients with moderate-to-severe chronic periodontitis ( CP ) who have been treated using SRP alone or SRP + PDT .


Twenty-two patients with two contralateral teeth affected with moderate-to-severe CP were selected .


After SRP , the participants ' teeth were randomized to receive either no further treatment or a single application of PDT using a 638-nm laser and toluidine blue .


Although the change in probing depth was the primary outcome , bleeding on probing , clinical attachment level , gingival recession , interleukin-1 , tumor necrosis factor ( TNF ) - , and matrix metalloproteinase 8 and 9 were also evaluated at baseline and 3 months postintervention .


An oral rinse assay was also performed to determine the total levels of oral polymorphonuclear cells ( PMNs ) before and 3 months after the treatments .


Within each group , significant improvements ( P < 0.001 ) were found for all variables in 3-month follow-up compared with baseline .


Only TNF - was significantly improved in the PDT + SRP versus SRP group .


Total levels of PMNs were reduced for all patients compared with baseline levels ( P < 0.001 ) .


In patients with CP , a single application of PDT ( using a 638-nm laser and toluidine blue ) did not provide any additional benefit to SRP in terms of clinical parameters or inflammatory markers 3 months following the intervention .


The combination of ketamine and remifentanil seems to be associated with better analgesia and duration .


The aim of this study was to evaluate whether a ketamine - remifentanil combination promotes improved postoperative analgesia .


Prospective , randomized , double blind study of 40 patients undergoing video laparoscopic cholecystectomy .


Anesthesia was performed with remifentanil , propofol , atracurium , and 50 % oxygen .


Group 1 ( GI ) patients received remifentanil ( 0.4 mcg.kg ( -1 ) .


min ( -1 ) ) and ketamine ( 5 mcg.kg ( -1 ) .


min ( -1 ) ) and Group 2 ( G2 ) received remifentanil ( 0.4 mcg.kg ( -1 ) .


min ( -1 ) ) and saline solution .


Morphine 0.1 mg.kg ( -1 ) was administered at the end of the procedure , and postoperative pain was treated with morphine via PCA .


We evaluated the severity of postoperative pain by a numerical scale from zero to 10 during 24 hours .


We registered the time to the first analgesic supplementation , amount of morphine used in the first 24 hours , and adverse effects .


There was a decrease in pain severity between extubation and other times evaluated in G1 and G2 .


There was no significant difference in pain intensity between the groups .


There was no difference between G1 ( 22 24.9 min ) and G2 ( 21.5 28.1 min ) regarding time to first dose of morphine and dose supplement of morphine consumed in G1 ( 29 18.4 mg ) and G2 ( 25.1 13.3 mg ) .


The combination of ketamine ( 5 mcg.kg ( -1 ) .


min ( -1 ) ) and remifentanil ( 0.4 mcg.kg ( -1 ) .