min ( -1 ) ) for cholecystectomy did not alter the severity of postoperative pain , time to first analgesic supplementation or dose of morphine in 24 hours .


To observe the efficacy of integrative medical sequential method in treating cerebral palsy ( CP ) children 's intelligence development , muscular tension , serum interleukin 6 ( IL-6 ) , and tumor necrosis factor alpha ( TNF-alpha ) .


Totally 111 CP children were randomly assigned to the control group ( 50 cases ) and the treatment group ( 61 cases ) .


All patients received comprehensive rehabilitation training and intravenous dripping of Monosialotetrahexosylganglioside Sodium Injection for 10 days .


But those in the treatment group additionally received Chinese medical enema for brain resuscitation , relieving rigidity of muscles and activating collaterals for 14 days .


Then they started another medication cycle and lasted for a total of 6 cycles .


Serum IL-6 levels and TNF-alpha contents were determined before treatment .


Scoring for muscular tension , Gesell score for intelligence development , contents of serum IL-6 and TNF-alpha were assessed before and after treatment in the two groups .


Compared with before treatment in this group , muscular tension , Gesell scores for intelligence development all decreased in the two groups ( P < 0.05 ) .


As for inter-group comparison , the decrement was more obvious in the treatment group than in the control group ( P < 0.05 ) .


The total effective rate was 86.9 % in the treatment group and 76.0 % in the control group ( P < 0.05 ) .


The contents of IL-6 and TNF-alpha were obviously reduced in the treatment group and the control group after treatment ( P < 0.01 ) .


The decrement was more obvious in the treatment group ( P < 0.05 ) .


The two treatment methods were effective for CP children , but the efficacy was superior in the treatment group than in the control group , indicating integrative medical methods could play a synergistic effect and optimize the treatment program for CP .


A post-hoc analysis was performed on the data from a 54weeks phase III study ( ClinicalTrials.gov identifier : NCT00923091 ) to measure changes in the health-related quality of life ( HRQoL ) of 2,690 patients aged 18 with moderate-to-severe hypertension who received one of six doses of olmesartan/amlodipine/hydrochlorothiazide ( OLM/AML/HCTZ ) , using the MINICHAL and EQ-5D instruments .


Descriptive statistics were used to assess blood pressure and HRQoL scores over the study period .


Analysis of covariance ( ANCOVA ) was used to identify those factors that could possibly have influenced HRQoL .


Linear regression was used to assess the relationship between changes in blood pressure and HRQoL scores .


Patients ' baseline MINICHAL mood and somatic domains scores were 5.5 and 2.6 .


Over the study period HRQoL improved as both MINICHAL scores decreased by 31-33 % .


Patients ' baseline EQ-5D index and VAS scores were 0.9 and 73.4 respectively , increasing by 6 % and 12 % over the study period .


Patients ' QALY gain over the 54weeks study period was estimated to be 0.029 QALYs .


The ANCOVA showed that changes in patients ' HRQoL was likely to have been influenced by patients ' achievement of blood pressure control , the amount of concomitant medication and patients ' last used dosage strength of antihypertensive .


Linear regression showed that blood pressure improvement may have been associated with improved HRQoL .


This study showed that OLM/AML/HCTZ reduced blood pressure and significantly increased blood pressure control whilst improving patients ' HRQoL .


Achieving blood pressure control , amount of concomitant medication and dosage strength of antihypertensive impacted on patients ' HRQoL .


The effect of anaesthetic drugs on long-term oncological outcomes after cancer surgery is an area of current interest .


Dexamethasone is widely used in anaesthetic practice ; however , its effect on long-term survival and cancer outcomes is not known .


This study presents the results of a 5-yr follow-up of patients receiving dexamethasone before elective colectomy as part of a previous randomized clinical trial .


Sixty patients who underwent elective open colonic resection for any indication between June 2006 and March 2008 were randomized to receive either 8 mg i.v. dexamethasone or placebo before surgery .


A 5-yr follow-up analysis was conducted to evaluate overall survival , disease-free survival and recurrence specifically for patients undergoing resection for Stage I-III colon cancer .


Kaplan-Meier analysis was performed and log-rank test was used to evaluate difference in survival between groups .


Forty-three of the 60 subjects had Stage I-III colon cancer and were included in the follow-up analysis .


Twenty received preoperative dexamethasone and 23 received placebo .


There were no significant differences between groups in baseline or disease characteristics .


No differences were found between groups for overall or disease-free survival .


In the dexamethasone group , there was a significantly higher rate of distant recurrence ( 6 compared with 1 , P = 0.04 ) .


Preoperative dexamethasone was associated with a higher rate of distant recurrence in patients undergoing colectomy for colon cancer .


Given the small sample size , this finding should be interpreted with caution , but warrants further investigation in a prospective study .


The EXAcerbations of Chronic Pulmonary Disease Tool ( EXACT ) is a patient-reported outcome measure to standardize the symptomatic assessment of chronic obstructive pulmonary disease exacerbations , including reported and unreported events .


The instrument has been validated in a short-term study of patients with acute exacerbation and stable disease ; its performance in longer-term studies has not been assessed .


To test the EXACT 's performance in three randomized controlled trials and describe the relationship between resource-defined medically treated exacerbations ( MTEs ) and symptom ( EXACT ) - defined events .


Prespecified secondary analyses of data from phase II randomized controlled trials testing new drugs for the management of chronic obstructive pulmonary disease : one 6-month trial ( United States ) ( n = 235 ) and two 3-month , multinational trials ( AZ 1 [ n = 749 ] , AZ 2 [ n = 597 ] ) .


In each case , the experimental drugs were found to be ineffective , permitting assessment of the EXACT 's performance in three independent studies of moderate to severe high-risk patients on maintenance therapies .


The mean age of subjects was 62 to 64 years ; 48 to 76 % were male .


Mean FEV1 % predicted was 42 to 59 % .


EXACT scores exhibited internal consistency ( Cronbach 's 0.90 ) , reproducibility ( intraclass correlation 0.70 ) , correlation with St. George 's Respiratory Questionnaire ( Spearman rho [ rs ] = 0.62 , 0.46 , 0.46 in the three trials ; P < 0.001 ) , and Breathlessness Cough and Sputum Scale ( AZ 1 , rs = 0.83 ; AZ 2 , rs = 0.83 ; P < 0.001 ) .


EXACT-defined events had a high correspondence with alternative indicators of worsening ( 94 , 88 , and 93 % ) .


In each trial , unreported events were similar in severity ( mean EXACT score , 56 , 57 , 61 vs. 53 , 54 [ P < 0.05 ] , 57 [ P < 0.05 ] , respectively ; 100-point scale ) and longer ( median , 9 , 8 , 7 vs. 8 , 7 [ P < 0.01 ] , 6 days , respectively ) than moderate MTEs .


Data generated through the EXACT offers insight into the symptomatic nature of MTEs and the frequency , severity , and duration of unreported symptom-defined events .


Clinical trials registered with www.clinicaltrials.gov ( MPEX : NCT00739648 ; AZ 1 : NCT00949975 ; AZ 2 : NCT01023516 ) .


Complex regional pain syndrome is multifactorial .


Exaggerated inflammatory responses to limb injury may be involved .


The authors hypothesized that capsaicin-induced pain and neurogenic inflammation ( skin perfusion and flare area ) are increased in patients with complex regional pain syndrome compared with that in controls .


Twenty patients with unilateral upper-limb complex regional pain syndrome and 20 age - , sex - , and body mass index-matched controls participated .


Topical capsaicin 5 % was applied to the back of both hands for 30 min , and pain intensity was assessed on a visual analogue scale .


A laser Doppler perfusion imager scanner estimated capsaicin-induced skin perfusion and flare area .


Autonomic and small-fiber function was assessed by sensory testing , quantitative sudomotor axon reflex test , and vasoconstrictor responses .


The authors found bilateral hypersensitivity to capsaicin ( P 0.02 ) , skin fold ( P = 0.001 ) , joint pressure ( P < 0.0001 ) , cold ( P 0.01 ) , and heat pain ( P 0.04 ) in patients compared with that in controls and thermal and mechanical hyperalgesia in the complex regional pain syndrome-affected hand compared with that in the unaffected hand ( P 0.001 ) .


The patients had normal capsaicin-induced flare areas , thermal detection thresholds , quantitative sudomotor axon reflex test , and vasoconstrictor responses .


The main finding is bilaterally increased capsaicin-induced pain in patients compared with controls .


The flare response to capsaicin was normal , suggesting that the increased pain response was not due to increased neurogenic inflammation .


The bilateral hypersensitivity to painful chemical , thermal , and mechanical stimuli not confined to the innervation area of a peripheral nerve or root can not be explained by a regional change and may partly be due to central sensitization .


Diurnal variation in serum growth hormone ( s-GH ) levels after exogenous GH delivery has previously been reported in patients with no endogenous GH secretion .


Changes in postural position or physical activity , leading to changes in blood flow and/or lymphatic drainage may be underlying explanations .


The primary aim of this study is to study a possible impact of exercise and supine rest on pharmacokinetics ( PK ) and day-to-day variation of subcutaneously ( s.c. ) administered GH in adult GH deficient ( AGHD ) patients .


The secondary aim of this study is to compare s-IGF-I , s-insulin , and plasma ( p ) - glucose profiles after a carbohydrate rich breakfast following s.c. GH injection vs. continuous infusion .


During supine rest eight AGHD males ( 59.88 years , BMI 29.74.9 kg/m ( 2 ) ) were treated with one daily s.c. GH injections of 3 mg/24 h for 48 h ( treatment sessions A , B ) or a continuous s.c. GH infusion of 3 mg/24 h for 60 h ( treatment sessions C , D ) .


Exercise comprised 1 h bicycling with 50 W load on two consecutive days during treatment sessions B and D.


Administration of GH as a bolus injection , but not as a continuous GH infusion , resulted in about 32 % higher s-GH levels during exercise ( 60 min ) as well as 30 min after ( s-GH logAUC ( B-A ) difference was 0.28 ; 95 % CI : 0.14-0 .4 ; p < 0.001 ) .


However , the total s-GH ( AUC 0-24 h ) ( p = 0.75 ) and s-IGF-I ( AUC0-48 h ) levels ( p = 0.51 ) remained unchanged between the two occasions .


P-glucose and insulin profiles were significantly higher after carbohydrate rich breakfast before first and second dosing both following s.c. GH injection and continuous infusion ( p < 0.05 ) .


Moderate exercise intermittently increased s-GH levels .


These changes seem to have no clinical short-term relevance , since total s-GH ( 24 h ) and s-IGF-I ( 48 h ) levels were unaffected .


The purpose of this prospective , randomised study was to evaluate long-term clinical results , radiographic findings , complications and revision and survivorship rates in patients < 55 years at a minimum of 16 years after undergoing bilateral , sequential , simultaneous , cemented and cementless total knee arthroplasties ( TKAs ) in the same patients .


Bilateral , sequential , simultaneous TKAs were performed in 80 patients ( 160 knees ) .


There were 63 women and 17 men with a mean age of 54.3 years ( range 49-55 ) , who received a cementless prosthesis in one knee and a cemented prosthesis in the other .


The mean follow-up was 16.6 years ( range 16-17 ) .


At final review , the mean Knee Society ( KS ) knee scores ( 95.8 versus 96.9 ) , Western Ontario and McMaster Universities ( WOMAC ) osteoarthritis ( OA ) index ( 25.4 versus 25.9 ) , range of motion ( ROM ) ( 125 versus 128 ) , patient satisfaction ( 8.1 versus 8.3 ) and radiological results were similar in both groups .


Femoral component survival rate was 100 % in both groups at 17 years ; at 17 years , the cemented tibial component survival rate was 100 % and the cementless tibial component 98.7 % .


No osteolysis was identified in either group .


Long-term results of both cementless and cemented TKAs were encouraging in patients with OA who were < 55 years .


However , we found no evidence to prove the superiority of cementless over cemented TKAs .


To assess the relationship between session-by-session mediators and treatment outcomes in traditional cognitive-behavioral therapy ( CBT ) and acceptance and commitment therapy ( ACT ) for social anxiety disorder .


Session-by-session changes in negative cognitions ( a theorized mediator of CBT ) and experiential avoidance ( a theorized mediator of ACT ) were assessed in 50 adult outpatients randomized to CBT ( n = 25 ) or ACT ( n = 25 ) for DSM-IV social anxiety disorder .


Multilevel modeling analyses revealed significant nonlinear decreases in the proposed mediators in both treatments , with ACT showing steeper decline than CBT at the beginning of treatment and CBT showing steeper decline than ACT at the end of treatment .


Curvature ( or the nonlinear effect ) of experiential avoidance during treatment significantly mediated posttreatment social anxiety symptoms and anhedonic depression in ACT , but not in CBT , with steeper decline of the Acceptance and Action Questionnaire at the beginning of treatment predicting fewer symptoms in ACT only .


Curvature of negative cognitions during both treatments predicted outcome , with steeper decline of negative cognitions at the beginning of treatment predicting lower posttreatment social anxiety and depressive symptoms .


Rate of change in negative cognitions at the beginning of treatment is an important predictor of change across both ACT and CBT , whereas rate of change in experiential avoidance at the beginning of treatment is a mechanism specific to ACT .


Although the benefits of physical activity ( PA ) on to prevent and manage non-communicable diseases are well known , strategies to help increase the levels of PA among different populations are limited .


Exercise-referral schemes have emerged as one effective approach to promote PA ; however , there is uncertainty about the feasibility and effectiveness of these schemes in settings outside high-income countries .


This study will examine the effectiveness of a scheme to refer hypertensive patients identified in Primary Health Care facilities ( PHCU ) of the Mexican social security institution to a group PA program offered in the same institution .


We will describe the methods of a cluster randomized trial study designed to evaluate the effectiveness of an exercise referral scheme to increasing physical activity in hypertensive patients compared to a non-referral scheme .


Four PHCU were selected for the study ; the PHCU will take part as the unit of randomization and sedentary hypertensive patients as the unit of assessment .


2 PHCU of control group ( GC ) will provide information to hypertensive patients about physical activity benefits and ways to increase it safely .


2 PHCU of intervention group ( IG ) will refer patients to sports facilities at the same institution , to follow a group-based PA program developed to increase the PA levels with a designed based on the Transtheoretical Model and Social Cognitive Theory .


To evaluate the effects of the intervention as well as short-term maintenance of the intervention 's effects , PA will be assessed at baseline , at 24 and 32 weeks of follow-up .


The main outcome will be the difference before and after intervention in the percentage of participants meeting recommended levels of PA between and within intervention and control groups .


PA will be measured through self-report and with objective measure by accelerometer .


This study will allow us to evaluate a multidisciplinary effort to link the primary care and community-based areas of the same health care system .


Our findings will provide important information about the feasibility and effectiveness of an exercise-referral scheme and will be useful for decision-making about the implementation of strategies for increasing PA among hypertensive and other clinical populations in Mexico and Latin America .


Clinicaltrials.gov Identifier : NCT01910935 .


Date of registration : 07/05/2013 .


Rheumatoid arthritis ( RA ) patients display high levels of oxidative stress .


Transient exercise-induced increases in oxidative stress are thought to be adaptive in healthy populations .


This study investigated the effect of exercise on markers of oxidative stress in RA , following acute exercise and a period of exercise training .


Acute exercise study : RA patients ( N = 12 , age : 5611 ) undertook a bout of exercise ( 30-40min , 70 % VO2MAX ) , and blood samples were taken before and after exercise to assess markers of oxidative stress .


Training study : RA patients ( N = 19 , age : 5610 ) were randomised into either a control or exercise group , who undertook 3 exercise sessions per week ( 30-40min @ 70 % VO2MAX ) for 3months .


Plasma markers of oxidative stress ( protein carbonyls ( PC ) , lipid hydroperoxides ( LOOH ) , 3-nitrotyrosine ( 3-NT ) , total antioxidant capacity ( TAC ) and catalase ( CAT ) activity ) , inflammation ( interleukin-8 ( IL-8 ) and C-reactive protein ( CRP ) ) and nitric oxide metabolites ( NOx ) were assessed before and after training .


Acute exercise study : Protein carbonyls ( PC ) ( +18 % ) and NOx ( +27 % ) were significantly increased following exercise .


Training study : 3-nitrotyrosine ( 3-NT ) decreased ( 2.181.78 to 1.100.93 M ) in the exercise group only , alongside increases in aerobic fitness ( 24.454.98 to 27.104.51 ml/kg/min ( -1 ) ) and reductions in disease activity score ( DAS : 3.471.17 to 2.880.76 ) .


PC , LOOH , TAC , IL-8 , CRP and NOx concentrations , and CAT activity were unchanged in both groups .


Aerobic exercise training did not increase markers of oxidative stress in RA patients .


3-Nitrotyrosine and disease activity were decreased following exercise training .


The application of internet technology for telerehabilitation in patients with stroke has developed rapidly .


The current study aimed to evaluate the effect of a bidirectional and multi-user telerehabilitation system on balance and satisfaction in patients with chronic stroke living in long-term care facilities ( LTCFs ) .


This pilot study used a multi-site , blocked randomization design .


Twenty-four participants from three LTCFs were recruited , and the participants were randomly assigned into the telerehabilitation ( Tele ) and conventional therapy ( Conv ) groups within each LTCF .


Tele group received telerehabilitation but the Conv group received conventional therapy with two persons in each group for three sessions per week and for four weeks .


The outcome measures included Berg Balance Scale ( BBS ) , Barthel Index ( BI ) , and the telerehabilitation satisfaction of the participants .


A telerehabilitation system included `` therapist end '' in a laboratory , and the `` client end '' in LTCFs .


The conventional therapy was conducted in LTCFs .


Training programs conducted for both the Tele and Conv groups showed significant effects within groups on the participant BBS as well as the total and self-care scores of BI .


No significant difference between groups could be demonstrated .


The satisfaction of participants between the Tele and the Conv groups also did not show significant difference .


This pilot study indicated that the multi-user telerehabilitation program is feasible for improving the balance and functional activity similar to conventional therapy in patients with chronic stroke living in LTCFs .


The reward value of food is partly dependent on learned associations .


It is not yet known whether replacing sugar with non-caloric sweeteners in food is affecting long-term acceptance .


To determine the effect of replacing sugar with non-caloric sweeteners in a nutrient-empty drink ( soft drink ) versus nutrient-rich drink ( yoghurt drink ) on reward value after repeated exposure .


We used a randomized crossover design whereby forty subjects ( 15 men , 25 women ) with a mean SD age of 21 2 y and BMI of 21.5 1.7 kg/m ( 2 ) consumed a fixed portion of a non-caloric sweetened ( NS ) and sugar sweetened ( SS ) versions of either a soft drink or a yoghurt drink ( counterbalanced ) for breakfast which were distinguishable by means of colored labels .


Each version of a drink was offered 10 times in semi-random order .


Before and after conditioning the reward value of the drinks was assessed using behavioral tasks on wanting , liking , and expected satiety .


In a subgroup ( n = 18 ) fMRI was performed to assess brain reward responses to the drinks .


Outcomes of both the behavioral tasks and fMRI showed that conditioning did not affect the reward value of the NS and SS versions of the drinks significantly .


Overall , subjects preferred the yoghurt drinks to the soft drinks and the ss drinks to the NS drinks .


In addition , they expected the yoghurt drinks to be more satiating , they reduced hunger more , and delayed the first eating episode more .


Conditioning did not influence these effects .


Our study showed that repeated consumption of a non-caloric sweetened beverage , instead of a sugar sweetened version , appears not to result in changes in the reward value .


It can not be ruled out that learned associations between sensory attributes and food satiating capacity which developed preceding the conditioning period , during lifetime , affected the reward value of the drinks .


We test the hypothesis that anesthesia , measured as pain scores , induced by a novel topical anesthetic putty is non-inferior ( margin = 1.3 ) to that provided by conventional lidocaine infiltration for the repair of lacerations .


A randomized controlled trial was conducted in the emergency department ( ED ) of a local hospital .


Participants were randomly allocated to receive either infiltration anesthesia or topical anesthetic putty as per the trial protocol .


Pain scores were recorded 15 minutes after infiltration and 30 minutes after topical anesthetic putty application .


Median pain scores were compared between groups .


Wound evaluation scores were conducted after 7 to 10 days and adverse events were monitored for both groups of participants throughout the study .


One hundred and ten participants were enrolled in the study , with 56 receiving infiltration and 54 receiving topical anesthetic putty .


The median difference between the pain scores of the 2 groups was 0 ( 95 % confidence interval -1 to 0 ) .


There were no substantial differences between the 2 groups in terms of either the wound evaluation scores or the incidence of adverse events .


The novel topical anesthetic putty was not inferior to infiltration with lidocaine with respect to the pain experienced during suturing , and this putty is a feasible alternative to infiltration anesthesia of lacerations in the ED .


To explore the value of preoperative evaluation with three-dimensional endoanal ultrasonography ( 3D-EAUS ) for anal fistula in order to provide preoperative assessment for anal fistula .


One hundred patients diagnosed with anal fistula undergoing surgery between March 2012 and March 2013 in our department were prospectively enrolled .


All the patients were randomly divided into the ultrasound group and the control group with fifty patients in each group .


The ultrasound group received 3D-EAUS and the control group received routine examinations ( digital examination and probe ) to assess the position of the internal opening , the type of fistula and secondary tracks , respectively .


The concordance rate of the preoperative assessment and intraoperative exploration was evaluated between the two groups .


The accuracy of identifying internal opening was 96.0 % for the ultrasound group and 82.0 % for the control group with statistically significant difference ( P = 0.02 ) .


The accuracy of identifying internal opening for simple anal fistula was similar ( 95.0 % vs. 91.3 % , P = 1 ) .


For complex anal fistula , the accuracy was also higher in the ultrasound group ( 96.7 % vs. 74.1 % , P = 0.025 ) .


The accuracy of fistula classification was 78.0 % for the ultrasound group and 96.0 % for the control group with significant difference ( P = 0.01 ) .


The accuracy of identifying a second track was higher in the ultrasound group ( 96.0 % vs. 82.0 % , P = 0.025 ) .


It is significantly superior for 3D-EAUS to detect the internal opening , fistula classification and identification of a second track in complex anal fistulas as compared to conventional examination .


3D-EAUS should be recommended as a preoperative assessment for anal fistula , especially for complex one .


The quality of integrated diabetes care is important for reducing the burden of diabetes .


Therefore , we have evaluated the effect of a supervision program on the quality of integrated diabetes care in the Netherlands in the 2011-2012 period .


In this cluster RCT , the supervision program was assigned to randomly selected care groups providing care to diabetes patients .


The supervision program included announcements of inspections , site visits , and sending individualized reports .


Indicators of effectiveness were derived from the structures , processes , and outcomes of care .


These indicators were collected from patients ' files , before and after the supervision program .


Hierarchical linear and logistic regression models were used to analyze data from 356 patients of 10 intervention and 8 control care groups .


Structures and processes of care did not improve more in the intervention groups than in the control care groups .


Moreover , health outcomes did not improve more in the intervention groups than in the control care groups .


Although structures of care improved over time in the total population of intervention and control care groups , there were no changes in process of care or health outcomes .


In this cluster RCT , we could not demonstrate improvements in quality of integrated diabetes care resulting from the supervision program .


Although structures of care did improve over time , other quality-improvement initiatives are necessary to substantially strengthen integrated care for diabetes patients .


Following a major burn , skeletal muscle protein synthesis rate increases but is often insufficient to compensate for massively elevated muscle protein breakdown rates .


Given the long-term nature of the pathophysiologic response to burn injury , we hypothesized that muscle protein synthesis rate would be chronically elevated in severely burned children .


The objectives of this study were to characterize muscle protein synthesis rate of burned children over a period of 24 months after injury and to identify predictors that influence this response .


A total of 87 children with 40 % or greater total body surface area ( TBSA ) burned were included .


Patients participated in stable isotope infusion studies at 1 , 2 , and approximately 4 weeks after burn and at 6 , 12 , and 24 months after injury to determine skeletal muscle protein fractional synthesis rate .


Generalized estimating equations with log link normal distribution were applied to account for clustering of patients and control for patient characteristics .


Patients ( 8 6 years ) had large ( 62 , 51-72 % TBSA ) and deep ( 47 % 21 % TBSA third degree ) burns .


Muscle protein fractional synthesis rate was elevated throughout the first 12 months after burn compared with established values from healthy young adults .


Muscle protein fractional synthesis rate was lower in boys , in children older than 3 years , and when burns were greater than 80 % TBSA .


Muscle protein synthesis is elevated for at least 1 year after injury , suggesting that greater muscle protein turnover is a component of the long-term pathophysiologic response to burn trauma .


Muscle protein synthesis is highly affected by sex , age , and burn size in severely burned children .


These findings may explain the divergence in net protein balance and lean body mass in different populations of burn patients .


Prognostic study , level III .


In this study , we evaluated long-term survival in patients treated with and without mechanical bowel preparation ( MBP ) before colorectal surgery for cancer .


Long-term outcome of patients of 2 main participating hospitals in a prior multicenter randomized trial comparing clinical outcome of MBP versus no MBP was reviewed .


Primary endpoint was cancer-related mortality and secondary endpoint was all-cause mortality .


A total of 382 patients underwent potentially curative surgery for colorectal cancer .


One hundred seventy-seven ( 46 % ) patients were treated with MBP and 205 ( 54 % ) were not before surgery .


Median follow-up was 7.6 years ( mean 6.6 , range .01 to 12.73 ) .


There was no significant difference in both cancer-related mortality and all-cause mortality in patients treated with MBP and without MBP ( P = .76 and P = .36 , respectively ) .


Multivariate analysis , taking account of age , sex , AJCC cancer stage , and ASA classification , also showed no survival difference .


Our results indicate that MBP does not seem to influence long-term survival in patients surgically treated for colorectal cancer .


Applying appropriate positive end-expiratory pressure ( PEEP ) to corresponding intra-abdominal pressure ( IAP ) can improve gas exchange during capnoperitoneum without any hemodynamic effects .


A total of 75 patients were randomly allocated to group 0PEEP ( n = 25 ) , group 5PEEP ( n = 25 ) , and group 10PEEP ( n = 25 ) according to the level of PEEP , in whom capnoperitoneum was created with IAP of 14 , 8 , and 14 mm Hg , respectively .


Hemodynamic and respiratory parameters were recorded up to 30 minutes after capnoperitoneum .


In 0PEEP group , mean end-tidal carbon dioxide demonstrated significant rise 2 minutes after capnoperitoneum and plateaued at about 15 minutes but remained at high level for up to 30 minutes when compared with the 5PEEP and 10PEEP groups ( P < 0.05 ) .


Correspondingly , the mean PaCO2 ( 48.04.1 mm Hg ) for the 0PEEP group was higher at 30 minutes when compared with 5PEEP ( 37.82.7 mm Hg ) and 10PEEP ( 37.23.9 mm Hg ) groups .


The oxygenation was better preserved in 5PEEP and 10PEEP groups with significantly higher PaO2/Fio2 ratio .


Heart rate , mean arterial pressure , and cardiac output remained stable throughout the study in all the 3 groups .


Application of appropriate PEEP corresponding to the IAP helped maintain CO2 elimination and improved oxygenation without any hemodynamic disturbance in patients undergoing laparoscopic cholecystectomy .


Isoflavones are present in soy foods and soy-based supplements .


Despite low plasma isoflavone concentrations in the general Western population , concentrations in supplement users exceed those suggested to be beneficial for health in Asian populations , raising concerns for adverse effects .


To aid risk assessment , quantification of the relation between isoflavone intake and plasma concentrations is essential .


Plasma samples were collected from postmenopausal women in three placebo-controlled crossover studies with 8-week periods for supplements ( two studies , ~ 100mg isoflavones/day , n = 88 ) or 4-week periods for soy foods ( one study , ~ 48mg isoflavones/day , n = 15 ) .


Plasma isoflavone concentrations ( daidzein , equol , genistein and glycitein ) were quantified using high-performance liquid chromatography and electrochemical detection .


The association between plasma concentrations and isoflavone intake , equol producer status , intake-producer interaction and background dietary intake was assessed based on the assumption of a log-linear relation .


Median plasma total isoflavone concentrations after the soy food and supplement interventions were respectively 2.16 and 3.47 mol/l for equol producers and 1.30 and 2.39 mol/l for non-producers .


Regression analysis showed that doubling isoflavone intake increased plasma concentrations by 55-62 % ( s.e. 1-2 % , R ( 2 ) > 0.87 ) for daidzein , genistein , equol ( only for producers ) and total isoflavones ; for glycitein the association was weaker ( 151 % , R ( 2 ) = 0.48 ) .


Adjustments for energy , carbohydrate and fat intake did not affect these estimates .


Inter-individual variation , estimated based on repeated measures in one of the studies , was 30-96 % .


Although the relation between isoflavone intake and plasma concentrations was adequately quantified , the use of isoflavone intake data for risk assessment needs caution due to large inter-individual variation in plasma concentrations .


The simultaneous presence of cancer and other medical conditions ( comorbidity ) is frequent .


Cigarette smoking is the major risk factor for as well head and neck cancer ( HNC ) and lung cancer ( LC ) as chronic obstructive pulmonary disease ( COPD ) .


COPD is the most common comorbidity in LC patients , and presence of COPD worsens the prognosis of HNC and LC .


COPD is under-diagnosed and under-treated in the Danish population .


The aims of this study were to determine the prevalence of COPD in a HNC and LC population , and to determine the need and feasibility of a randomized controlled phase II trial comparing usual care with optimized medical treatment of COPD in cancer patients .


All patients with HNC or LC referred for oncologic treatment in a university hospital during a 10-month period were invited to attend a pulmonary clinic for evaluation of lung function .


Patients who were found to have concomitant COPD were randomized to intervention or usual care .


Primary endpoints were prevalence of COPD among the referred patients with either LC or HNC , and further whether the patients that were diagnosed with COPD already received treatment in accordance with Danish COPD guidelines .


Secondary outcome was feasibility , i.e. the proportion of eligible patients that accepted follow-up in the pulmonary clinic for 24 weeks in addition to oncological treatment .


The design of the randomized trail is described in detail .


In total 130 patients of whom 65 % had LC and 35 % HNC have been screened during the first seven months of this ongoing trial .


Sixty-eight percent of LC patients and 22 % of HNC patients had COPD .


All but one of 68 eligible patients accepted randomization .


Nearly one third ( 31 % ) of the LC and HNC patients with COPD were diagnosed prior to study entry , and of these , only 33 % were receiving correct treatment according to current guidelines .


For patients with LC , and to a lesser extend HNC , there is a need for improved diagnosis and treatment of concomitant COPD .


Furthermore , patients found it acceptable to be scheduled for a 24-week follow-up in a pulmonary clinic along with their oncological treatment .


Existing eye-tracking literature has shown that both adults and children with autism spectrum disorders ( ASD ) show fewer and slower fixations on faces .


Despite this reduced saliency and processing of other faces , recognition of their own face is reported to be more `` typical '' in nature .


This study uses eye-tracking to explore the typicality of gaze patterns when children with ASD attend their own faces compared to other familiar and unfamiliar faces .


Eye-tracking methodology was used to explore fixation duration and time taken to fixate on the Eye and Mouth regions of familiar , unfamiliar and Self Faces .


Twenty-one children with ASD ( 9-16 years ) were compared to typically developing matched groups .


There were no significant differences between children with ASD and typically matched groups for fixation patterns to the Eye and Mouth areas of all face types ( familiar , unfamiliar and self ) .


Correlational analyses showed that attention to the Eye area of unfamiliar and Self Faces was related to socio-communicative ability in children with ASD .


Levels of socio-communicative ability in children with ASD were related to gaze patterns on unfamiliar and Self Faces , but not familiar faces .


This lack of relationship between ability and attention to familiar faces may indicate that children across the autism spectrum are able to fixate these faces in a similar way .


The implications for these findings are discussed .


To determine if increasing the hormone dose or eliminating the hormone-free interval improves key pharmacokinetic ( PK ) alterations caused by obesity during oral contraceptive ( OC ) use .


Obese [ body mass index ( BMI ) 30 kg/m ( 2 ) ] , ovulatory , otherwise healthy , women received an OC containing 20 mcg ethinyl estradiol ( EE ) / 100 mcg levonorgestrel ( LNG ) dosed cyclically ( 21 days active pills with 7-day placebo week ) for two cycles and then were randomized for two additional cycles to the following : continuous cycling ( CC , a dose neutral arm using the same OC with no hormone-free interval ) or increased dose ( ID , a dose escalation arm using an OC containing 30 mcg EE/150 mcg LNG cyclically ) .


During Cycles 2 , 3 and 4 , outpatient visits were performed to assess maximum serum concentration ( Cmax ) , area under the curve ( AUC0 - ) and time to steady state as well as pharmacodynamics .


These key PK parameters were calculated and compared within groups between baseline and treatment cycles .


A total of 31 women enrolled and completed the study ( CC group , n = 16 ; ID group , n = 15 ) .


Demographics were similar between groups [ mean BMI : CC , 38 kg/m ( 2 ) ( S.D. 5.1 ) ; ID , 41 kg/m ( 2 ) ( S.D. 7.6 ) ] .


At baseline , the key LNG PK parameters were no different between groups ; average time to reach steady state was 12 days in both groups ; Cmax were CC : 3.821.28 ng/mL and ID : 3.130.87 ng/mL ; and AUC0 - were CC : 267115 h ng/mL and ID : 19975 h ng/mL .


Following randomization , the CC group maintained steady-state serum levels whereas the ID group had a significantly higher Cmax ( p < .001 ) but again required 12 days to achieve steady state .


However , AUC was not significantly different between CC ( 412255 h ng/mL ) and ID ( 283130 h ng/mL ) .


Forty-five percent ( 14/31 ) of the study population had evidence of an active follicle-like structure prior to randomization and afterwards this decreased to 9 % ( 3/31 ) .


Both increasing the OC dose and continuous dosing appear to counteract the impact of obesity on key OC PK parameters .


Obesity adversely affects the pharmacokinetics of very low dose OC pills .


Although the impact of these changes on OC efficacy is still under debate , PK parameters can be normalized in obese users by continuous dosing or increasing to a low-dose pill .


Postural balance and potentially fall risk increases among older adults living with neurological diseases , especially Parkinson 's disease ( PD ) .


Since conventional therapies such as levodopa or deep brain stimulation may fail to alleviate or may even worsen balance , interest is growing in evaluating alternative PD therapies .


The purpose of the current study was to assess improvement in postural balance in PD patients following electroacupuncture ( EA ) as an alternative therapy .


15 aging adults ( 71.2 6.3 years ) with idiopathic PD and 44 healthy age-matched participants ( 74.6 6.5 years ) were recruited .


The PD participants were randomly assigned ( at a ratio of 2:1 ) to an intervention ( n = 10 ) or to a control group ( n = 5 ) .


The intervention group received a 30-min EA treatment on a weekly basis for 3 weeks , while the control group received a sham treatment .


Outcomes were assessed at baseline and after the final therapy .


Measurements included balance assessment , specifically the ratio of medial-lateral ( ML ) center-of-gravity ( COG ) sway to anterior-posterior ( AP ) sway ( COGML/AP ) and ankle/hip sway during eyes-open , eyes-closed , and eyes-open dual-task trials , the Unified Parkinson 's Disease Rating Scale ( UPDRS ) , as well as quality of life , concerns for fall , and pain questionnaires .


No difference was observed for the assessed parameters between the intervention and the control group at baseline .


After treatment , an improvement in balance performance was observed in the intervention group .


Compared with the healthy population , PD patients prior to treatment had larger COGML/AP sway with more dependency on upper-body movements for maintaining balance .


Following EA therapy , COGML/AP sway was reduced by 31 % and ankle/hip sway increased by 46 % in the different conditions ( p = 0.02 for the dual-task condition ) .


The clinical rating revealed an overall improvement ( p < 0.01 ) in mentation , behavior , and mood ( UPDRS part I , 49 % ) , activities of daily living ( UPDRS part II , 46 % ) , and motor examination ( UPDRS part III , 40 % ) .


There was a significant reduction ( p < 0.02 ) in the specific items regarding UPDRS fall status ( 67 % ) and rigidity ( 48 % ) .


Changes were small and nonsignificant in the controls ( p > 0.29 ) .


This pilot study demonstrates improvement in rigidity and balance following EA .


These preliminary results suggest EA could be a promising alternative treatment for balance disturbance in PD .


Smoking reduction remains a pivotal issue in public health policy , but quit rates obtained with traditional quit-smoking therapies remain disappointingly low .


Tobacco Harm Reduction ( THR ) , aiming at less harmful ways of consuming nicotine , may provide a more effective alternative .


One promising candidate for THR are electronic cigarettes ( e-cigs ) .


The aim of this study was to investigate the efficacy of second-generation e-cigs both in terms of acute craving-reduction in the lab and in terms of smoking reduction and experienced benefits/complaints in an eight-month Randomized Controlled Trial ( RCT ) .


RCT with three arms .


Participants ( N = 48 ) unwilling to quit smoking were randomized into two e-cig groups and one control group .


During three lab sessions ( over two months ) participants , who had been abstinent for four hours , vaped/smoked for five minutes , after which we monitored the effect on craving and withdrawal symptoms .


eCO and saliva cotinine levels were also measured .


In between lab sessions , participants in the e-cig groups could use e-cigs or smoke ad libitum , whereas the control group could only smoke .


After the lab sessions , the control group also received an e-cig .


The RCT included several questionnaires , which repeatedly monitored the effect of ad libitum e-cig use on the use of tobacco cigarettes and the experienced benefits/complaints up to six months after the last lab session .


From the first lab session on , e-cig use after four hours of abstinence resulted in a reduction in cigarette craving which was of the same magnitude as when a cigarette was smoked , while eCO was unaffected .


After two months , we observed that 34 % of the e-cig groups had stopped smoking tobacco cigarettes , versus 0 % of the control group .


After five months , the e-cig groups demonstrated a total quit-rate of 37 % , whereas the control group showed a quit rate of 38 % three months after initiating e-cig use .


At the end of the eight-month study , 19 % of the e-cig groups and 25 % of the control group were totally abstinent from smoking , while an overall reduction of 60 % in the number of cigarettes smoked per day was observed ( compared to intake ) .


eCO levels decreased , whereas cotinine levels were the same in all groups at each moment of measurement .


Reported benefits far outweighed the reported complaints .


In a series of controlled lab sessions with e-cig nave tobacco smokers , second generation e-cigs were shown to be immediately and highly effective in reducing abstinence induced cigarette craving and withdrawal symptoms , while not resulting in increases in eCO .


Remarkable ( > 50 pc ) eight-month reductions in , or complete abstinence from tobacco smoking was achieved with the e-cig in almost half ( 44 % ) of the participants .


Improving nutrition and physical activity behaviors associated with childhood obesity are significant national public health goals .


Energy Balance for Kids with Play ( EB4K with Play ) , developed through a partnership between the Academy of Nutrition and Dietetics Foundation and Playworks , is a multi-component school-based intervention designed to address youth 's nutrition and physical activity behaviors .


This article describes the EB4K with Play intervention and evaluation study and presents the baseline data .


The evaluation is a 2-year cluster-randomized design targeting third - to fifth-grade students enrolled in a low-income , urban school district in northern California .


Six schools were recruited to participate .


Four were randomized to the intervention group and two into a control group .


Baseline student-level data pertaining to nutrition , physical activity , fitness , and BMI were collected in the fall of 2011 .


The EB4K with Play program , which includes direct-to-student nutrition and physical activity interventions , a school wellness component , and parent/community partner outreach components , began immediately after baseline data collection .


An ethnically diverse sample of students ( n = 844 ) was recruited to participate in the study .


Baseline data showed a higher percent of eligibility for free and reduced-price school lunch and higher rates of obesity/overweight than the California state averages .


Fitness levels and levels of moderate-to-vigorous physical activity were comparable to state averages .


End-point data will be collected after 2 years of the intervention .


The findings from this study should help guide future efforts to design effective intervention programs to support the prevention of pediatric obesity .


A topical fixed-dose clindamycin phosphate 12 % and benzoyl peroxide 30 % combination gel ( CLNP/BPO 3 % ) is known to be effective and safe in white people with acne .


To evaluate the efficacy and safety of CLNP/BPO 30 % topically applied once or twice daily vs. CLNP twice daily in Japanese patients with acne .


Eight hundred patients were randomized to receive CLNP/BPO 30 % once daily , CLNP/BPO 30 % twice daily or CLNP twice daily for 12weeks .


Primary endpoints were absolute change in number of total lesions ( TLs ) from baseline to week 12 to demonstrate the superiority of CLNP/BPO 30 % twice daily and noninferiority of CLNP/BPO 30 % once daily vs. CLNP twice daily .


Secondary endpoints were absolute and percentage changes in TLs , inflammatory lesions ( ILs ) , noninflammatory lesions ( non-ILs ) and Investigator 's Static Global Assessment ( ISGA ) score .


Safety assessments included adverse events ( AEs ) , laboratory tests , vital signs and local skin tolerability .


Change in TL counts from baseline to week 12 for CLNP/BPO 30 % twice daily was superior to CLNP twice daily ( difference -110 ; P < 001 ) ; CLNP/BPO 30 % once daily was not inferior to CLNP twice daily ( difference -103 ; P < 001 ) .


Absolute and percentage reductions in TL , IL and non-IL counts and ISGA score were greater for CLNP/BPO 30 % once or twice daily than for CLNP twice daily with significant differences seen from early on .


Most AEs were mild or moderate .


The incidence of adverse drug reactions was higher for CLNP/BPO 30 % once ( 240 % ) or twice ( 351 % ) daily than for CLNP twice daily ( 90 % ) .


Compared with CLNP twice daily , CLNP/BPO 30 % once daily was more effective and CLNP/BPO 30 % twice daily at least as effective , with an early onset of action and an acceptable safety and tolerability profile in Japanese patients .


No effective pharmaceutical agents have yet been identified to treat acute kidney injury after cardiac surgery .


To determine whether fenoldopam reduces the need for renal replacement therapy in critically ill cardiac surgery patients with acute kidney injury .


Multicenter , randomized , double-blind , placebo-controlled , parallel-group study from March 2008 to April 2013 in 19 cardiovascular intensive care units in Italy .


We randomly assigned 667 patients admitted to intensive care units after cardiac surgery with early acute kidney injury ( 50 % increase of serum creatinine level from baseline or oliguria for 6 hours ) to receive fenoldopam ( 338 patients ) or placebo ( 329 patients ) .


We used a computer-generated permuted block randomization sequence for treatment allocation .


All patients completed their follow-up 30 days after surgery , and data were analyzed according to the intention-to-treat principle .


Continuous infusion of fenoldopam or placebo for up to 4 days with a starting dose of 0.1 g/kg/min ( range , 0.025-0 .3 g/kg/min ) .


The primary end point was the rate of renal replacement therapy .


Secondary end points included mortality ( intensive care unit and 30-day mortality ) and the rate of hypotension during study drug infusion .


The study was stopped for futility as recommended by the safety committee after a planned interim analysis .


Sixty-nine of 338 patients ( 20 % ) allocated to the fenoldopam group and 60 of 329 patients ( 18 % ) allocated to the placebo group received renal replacement therapy ( P = .47 ) .


Mortality at 30 days was 78 of 338 ( 23 % ) in the fenoldopam group and 74 of 329 ( 22 % ) in the placebo group ( P = .86 ) .


Hypotension occurred in 85 ( 26 % ) patients in the fenoldopam group and in 49 ( 15 % ) patients in the placebo group ( P = .001 ) .


Among patients with acute kidney injury after cardiac surgery , fenoldopam infusion , compared with placebo , did not reduce the need for renal replacement therapy or risk of 30-day mortality but was associated with an increased rate of hypotension .


clinicaltrials.gov Identifier : NCT00621790 .


Osteoarthritis ( OA ) is a common problem in older women that is associated with pain and disabilities .


Although yoga is recommended as an exercise intervention to manage arthritis , there is limited evidence documenting its effectiveness , with little known about its long term benefits .


This study 's aims were to assess the feasibility and potential efficacy of a Hatha yoga exercise program in managing OA-related symptoms in older women with knee OA .


Eligible participants ( N = 36 ; mean age 72 years ) were randomly assigned to 8-week yoga program involving group and home-based sessions or wait-list control .


The yoga intervention program was developed by a group of yoga experts ( N = 5 ) .


The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) total score that measures knee OA pain , stiffness , and function at 8 weeks .


The secondary outcomes , physical function of the lower extremities , body mass index ( BMI ) , quality of sleep ( QOS ) , and quality of life ( QOL ) , were measured using weight , height , the short physical performance battery ( SPPB ) , the Pittsburgh Sleep Quality Index ( PSQI ) , the Cantril Self-Anchoring Ladder , and the SF12v2 Health Survey .


Data were collected at baseline , 4 weeks and 8 weeks , and 20 weeks .


The recruitment target was met , with study retention at 95 % .


Based on ANCOVAs , participants in the treatment group exhibited significantly greater improvement in WOMAC pain ( adjusted means [ SE ] ) ( 8.3 [ .67 ] , 5.8 [ .67 ] ; p = .01 ) , stiffness ( 4.7 [ .28 ] , 3.4 [ .28 ] ; p = .002 ) and SPPB ( repeated chair stands ) ( 2.0 [ .23 ] , 2.8 [ .23 ] ; p = .03 ) at 8 weeks .


Significant treatment and time effects were seen in WOMAC pain ( 7.0 [ .46 ] , 5.4 [ .54 ] ; p = .03 ) , function ( 24.5 [ 1.8 ] , 19.9 [ 1.6 ] ; p = .01 ) and total scores ( 35.4 [ 2.3 ] , 28.6 [ 2.1 ] ; p = .01 ) from 4 to 20 weeks .


Sleep disturbance was improved but the PSQI total score declined significantly at 20 weeks .


Changes in BMI and QOL were not significant .


No yoga related adverse events were observed .


A weekly yoga program with home practice is feasible , acceptable , and safe for older women with knee OA , and shows therapeutic benefits .


ClinicalTrials.gov : NCT01832155 .


To select suitable chemotherapy for cervical cancer patients by ATP-tumor chemosensitivity assay .


Seventy-two hospitalized patients with cervical cancer between July 2007 and October 2009 were enrolled .


The patients were randomly divided into a trial group ( n = 35 ) and a control group ( n = 37 ) .


ATP-TCA was used to detect the sensitivity of 35 samples of cervical cancer in the trial group to 6 combined chemotherapy regimens .


The chemotherapy regimen in the trial group was confirmed by the results of susceptibility testing and that in the control group was confirmed by clinical experience .


One-year recurrence rate and 3 - year survival rate of two groups were compared after 3 year follow-up .


ATP-TCA was measured in 32 of the 35 patients in the trial group .


The sensitive patients for paclitaxel + carboplatin , paclitaxel + oxaliplatin , bleomycin + ifosfamide + cisplatin , bleomycin + vincristine + cisplatin , fluorouracil + cisplatin , and gemcitabine + cisplatin were 20 , 18 , 17 , 18 , 17 , and 21 , respectively .


There was no significant difference in the 1-year recurrence between the two groups ( P > 0.05 ) , while the 3-year survivors in the trial group were more than those in the control group ( P < 0.05 ) .


ATP-TCA method is good for patients with cervical cancer because it is sensitive , effective , and individualized .


Exercise is a potential treatment for depression .


However , few studies have evaluated the role of adjunct exercise in the treatment of severely major depressed inpatients .


The goal of this study was to evaluate the effects of add-on exercise on the usual treatment of severely depressed inpatients .


Fifty participants were randomized to an exercise ( exercise + usual treatment ) or a control ( usual treatment ) group .


Twenty-five patients were randomly allocated to each group .


The participants in the exercise group performed three sessions per week throughout the hospitalization period , with a goal dose of 16.5 kcal/kg/week plus the usual pharmacological treatment .


Depressive symptoms and the Quality of Life ( QoL ) of the participants were assessed at the baseline , the second week , and discharge .


A significant group time interaction was found for depressive symptoms and the physical and psychological domains of QoL .


Differences between groups occurred at the second week and discharge with respect to depressive symptoms and the physical and psychological domains of QoL .


There was no difference in the remission rate at discharge ( 48 % and 32 % for the exercise and control group , respectively ) .


An NNT of 6.25 was found .


No significant baseline characteristics predict remission at discharge .


Add-on exercise is an efficacious treatment for severely depressed inpatients , improving their depressive symptoms and QoL .


Initial acceptance of exercise remains a challenge .


The IMProved Reduction of Outcomes : Vytorin Efficacy International Trial ( IMPROVE-IT ) is evaluating the potential benefit for reduction in major cardiovascular ( CV ) events from the addition of ezetimibe versus placebo to 40 mg/d of simvastatin therapy in patients who present with acute coronary syndromes and have low-density lipoprotein cholesterol ( LDL-C ) 125 mg/dl .


Randomized double blind clinical trial in patients with acute coronary syndrome and low cholesterol level .


The simvastatin monotherapy arms LDL-C target was < 70 mg/dl , the comparison arm was simvastatin + ezetimibe .


Ezetimibe was assumed to further lower LDL-C by 15 mg/dl and produce an estimated ~ 8 % to 9 % treatment effect .


The primary composite end point was CV death , nonfatal myocardial infarction ( MI ) , nonfatal stroke , rehospitalization for unstable angina ( UA ) , and coronary revascularization ( 30 days postrandomization ) .


The targeted number of events was 5,250 .


18,144 patients were enroled with either ST segment elevation MI ( STEMI , n = 5,192 ) or UA/non-ST segment elevation MI ( UA/NSTEMI , n = 12,952 ) from October 2005 to July 2010 .


Primary endpoint occured in 2742 patients ( 34.7 % ) treated with simvastatin in monotherapy and in 2572 patients ( 32.7 % ) ( p = 0.016 ) treated with combination .


Compared to patients with coronary heart disease given the drug simvastatin plus a placebo , those given both simvastatin and the non-statin drug , ezetimibe , had a 6.4 % lower combined risk of subsequent heart attack , stroke , cardiovascular death , rehospitalization for unstable angina and procedures to restore blood flow to the heart .


Heart attacks alone were reduced by 13 % , and non-fatal stroke by 20 % .


Deaths from cardiovascular disease were statistically the same in both groups .


Patients were followed an average of approximately six years , and some as long as 8.5 years .


Approximately 2 patients out of every 100 patients treated for 7 years avoided a heart attack or stroke [ Number Needed to Treat ( NNT ) = 50/7 years ] .


The study has shown a claer benefit from combination treatment with simvastatin and ezetimibe in patients with acute coronary syndrome and low LDL-C .


We investigated the feasibility and acceptance of electronic monitoring of symptoms and syndromes in oncological outpatient clinics using a PALM ( handheld computer ) .


The assessment of a combination of symptoms and clinical benefit parameters grouped in four pairs was tested in a pilot phase in advanced cancer patients .


Based on these experiences , the software E-MOSAIC was developed , consisting of patient-reported symptoms and nutritional intake and objective assessments ( weight , weight loss , performance status and medication for pain , fatigue , and cachexia ) .


E-MOSAIC was then tested in four Swiss oncology centers .


In order to compare the methods , patients completed the E-MOSAIC as a paper and a PALM version .


Preferences of version and completion times were collected .


Assessments were compared using Wilcoxon signed-rank tests , and the test-retest reliability was evaluated .


The pilot phase was completed by 22 patients .


Most patients and physicians perceived the assessment as useful .


Sixty-two patients participated in the feasibility study .


Twelve patients reported problems ( understanding , optical , tactile ) , and five patients could not complete the assessment .


The median time to complete the PALM-based assessment was 3min .


Forty-nine percent of patients preferred the PALM , 23 % preferred a paper version , and 28 % of patients had no preference .


Paper vs. PALM revealed no significant differences in symptoms , but in nutritional intake ( p = 0.013 ) .


Test-retest ( 1h , n = 20 ) reliability was satisfactory ( r = 073-98 ) .


Electronic symptom and clinical benefit monitoring is feasible in oncology outpatient clinics and perceived as useful by patients , oncology nurses , and oncologists .


E-MOSAIC is tested in a prospective randomized trial .


To perform a comparative evaluation of the efficacy and acceptability of Rose-K and Soper contact lenses in Keratoconus .


Dr. Rajendra Prasad Center for Ophthalmic Sciences , All India Institute of Medical Sciences , New Delhi .


A randomized comparative clinical trial was performed in keratoconic eyes fitted with Rose-K ( Rose-K group ) and Soper ( Soper group ) contact lenses .


Patients data were evaluated for best spectacle corrected visual acuity , best contact lens corrected visual acuity ( BCLCVA ) , corneal topography , glare acuity , contrast sensitivity , tear function tests and specular microscopy .


Patients were also asked to complete a self-reported comfort questionnaire at each visit .


Sixty eyes were randomized to the Rose-K and Soper groups .


The two groups were comparable in all the baseline parameters .


There was a statistically significant improvement in BCLCVA in both groups at 3 months ( P < 0.01 , both groups ) .


The difference between in BCLCVA in both groups was not statistically significant .


In both groups , there was a significant improvement in the comfort score at 3 months compared to baseline ( P < 0.05 , both group ) .


The Rose-K group had statistically significantly better scores at 1 and 3 months compared with the Soper group ( P = 0.006 and P < 0.001 respectively ) .


Both groups were associated with a significant ( P < 0.01 ) , but comparable improvement in glare acuity at 3 months .


There was a significant improvement in contrast sensitivity at 3 months in both groups ( P < 0.01 ) ; the Rose-K group was significantly better than the Soper group at 1 and 3 months ( P = 0.001 and 0.002 respectively ) .


The mean number of trial lenses required for fitting Rose-K lens ( 2.00 0.59 ) was significantly lower than the Soper lens ( 3.43 0.82 ; P < 0.001 ) .


Both the contact lens designs provide an equal improvement in visual acuity in patients with Keratoconus .


However , Rose-K contact lens provides greater comfort , better quality of vision and requires less chair time compared with the Soper lens and hence may possibly have a greater acceptability .


To observe the effect of electroacupuncture ( EA ) combined with ultraviolet therapy on herpes zoster at the acute stage and the impacts on serum interleukin 2 ( IL-2 ) , interleukin 6 ( IL-6 ) and interleukin 10 ( IL-10 ) in the patients .


Thirty-four patients of herpes zoster were randomized into a medicine group and a combined therapy group , 17 cases in each one .


In the medicine group , the intravenous drops with acyclovir injection , muscular injection with cobamamide and the topical with acyclovir ointment were applied .


Additionally , TDP was radiated locally .


In the combined therapy group , on the basis of the treatment as the medicine group , EA and ultraviolet therapy were supplemented .


The duration of treatment was 10 days in the two groups .


Before and after treatment , blister relief , incrustation time and the visible analogue scale ( VAS ) were recorded in the two groups .


The clinical efficacy was assessed in the two groups and the levels of serum IL-2 , IL-6 and IL-10 were determined in the two groups .


In the combined therapy group , the time of blister relief and incrustation was earlier apparently than that in the medicine group ( both P < 0.05 ) .


VAS score after treatment were reduced as compared with that before treatment in the two groups ( both P < 0.01 ) , and the reducing amplitude in the combined therapy group was larger than that in the medicine group ( P < 0.01 ) .


The total effective rate was 94.1 % ( 16/17 ) in the combined therapy group , higher than 76.4 % ( 13/17 ) in the medicine group ( P < 0.05 ) .


After treatment , IL-2 levels were increased as compared with those before treatment in the two groups ( both P < 0.05 ) , the levels of IL-6 and IL-10 were reduced obviously as compared with those before treatment in the two groups ( all P < 0.01 ) .


After treatment , the levels of IL-6 , IL-10 were reduced much more apparently in the combined therapy group as compared with those in the medicine group ( both P < 0.05 ) .


EA combined with ultraviolet irradiation more rapidly and effectively relief the symptoms of herpes zoster , significantly relief pain , shorten the duration of sickness , improve the body immunity and reduce nerve injury .


Imatinib mesylate ( IM ) is a selective tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors .


A new once-daily 400-mg film-coated tablet of imatinib has been developed by a pharmaceutical company in Korea .


The present study was designed to assess and compare the PK parameters , bioavailability , and bioequivalence of the new imatinib 400-mg formulation ( test ) versus the conventional 100-mg formulation ( reference ) administered as a single 400-mg dose in healthy adult male volunteers .


This randomized , open-label , single-dose , two-way crossover study was conducted in healthy Korean male volunteers .


Eligible subjects were randomly assigned in a 1 : 1 ratio to receive 400 mg of the test ( one 400-mg tablet ) or reference ( four 100-mg tablets ) formulation , followed by a 2-week washout period and administration of the alternate formulation .


Serial blood samples were collected at 0 ( predose ) , 0.5 , 1 , 1.5 , 2 , 2.5 , 3 , 4 , 6 , 8 , 10 , 12 , 24 , 48 , and 72 hours after administration .


Plasma imatinib concentrations were determined using liquid chromatography coupled with tandem mass spectrometry .


The formulations were to be considered bioequivalent if the 90 % confidence intervals ( CIs ) of the adjusted geometric mean ratios for Cmax , AUC ( 0-t ) , and AUC ( 0 - ) were within the predetermined range of 0.80 - 1.25 .


In total , 35 subjects completed the study .


No serious adverse event was reported during the study .


The 90 % CIs of the adjusted geometric mean ratios of the test formulation to the reference formulation for C ( max ) , AUC ( 0-t ) and AUC ( 0 - ) of imatinib were all within the bioequivalence criteria range of 0.8 - 1.25 .


The test formulation of imatinib met the Korean regulatory requirements for bioequivalence .


Both imatinib formulations were well-tolerated in all subjects .


To assess the safety and effectiveness of the Hydrus Microstent ( Ivantis , Inc , Irvine , CA ) with concurrent cataract surgery ( CS ) for reducing intraocular pressure ( IOP ) in open-angle glaucoma ( OAG ) .


Prospective , multicenter , randomized , single-masked , controlled clinical trial .


One hundred eyes from 100 patients 21 to 80 years of age with OAG and cataract with IOP of 24 mmHg or less with 4 or fewer hypotensive medications and a washed-out diurnal IOP ( DIOP ) of 21 to 36 mmHg .


On the day of surgery , patients were randomized 1:1 to undergo CS with the microstent or CS alone .


Postoperative follow-up was at 1 day , 1 week , and 1 , 3 , 6 , 12 , 18 , and 24 months .


Washout of hypotensive medications was repeated at 12 and 24 months .


Response to treatment was defined as a 20 % or more decrease in washed out DIOP at 12 and 24 months of follow-up compared with baseline .


Mean DIOP at 12 and 24 months , the proportion of subjects requiring medications at follow-up , and the mean number of medications were analyzed .


Safety measures included change in visual acuity , slit-lamp observations , and adverse events .


The proportion of patients with a 20 % reduction in washed out DIOP was significantly higher in the Hydrus plus CS group at 24 months compared with the CS group ( 80 % vs. 46 % ; P = 0.0008 ) .


Washed out mean DIOP in the Hydrus plus CS group was significantly lower at 24 months compared with the CS group ( 16.93.3 mmHg vs. 19.24.7 mmHg ; P = 0.0093 ) , and the proportion of patients using no hypotensive medications was significantly higher at 24 months in the Hydrus plus CS group ( 73 % vs. 38 % ; P = 0.0008 ) .


There were no differences in follow-up visual acuity between groups .


The only notable device-related adverse event was focal peripheral anterior synechiae ( 1-2 mm in length ) .


Otherwise , adverse event frequency was similar in the 2 groups .


Intraocular pressure was clinically and statistically significantly lower at 2 years in the Hydrus plus CS group compared with the CS alone group , with no differences in safety .


To determine whether bronchoalveolar lavage ( BAL ) - directed therapy for infants and young children with cystic fibrosis ( CF ) , rather than standard therapy , was justified on the grounds of a decrease in average costs and whether the use of BAL reduced treatment costs associated with hospital admissions .


Costs were assessed in a randomized controlled trial conducted in Australia and New Zealand on infants diagnosed with CF after newborn screening and assigned to receive either BAL-directed or standard therapy until they reached 5 years of age .


A health care funder perspective was adopted .


Resource use measurement was based on standardized data collection forms administered for patients across all sites .


Unit costs were obtained primarily from government schedules .


Mean costs per child during the study period were Australian dollars ( AUD ) 92860 in BAL-directed therapy group and AUD90958 in standard therapy group ( mean difference AUD1902 , 95 % CI AUD-27782 to 31586 , P = .90 ) .


Mean hospital costs per child during the study period were AUD57302 in the BAL-directed therapy group and AUD66590 in the standard therapy group ( mean difference AUD-9288 ; 95 % CI AUD-35252 to 16676 , P = .48 ) .


BAL-directed therapy did not result in either lower mean hospital admission costs or mean costs overall compared with managing patients with CF by a standard protocol based upon clinical features and oropharyngeal culture results alone .


Following on our previous findings that BAL-directed treatment offers no clinical advantage over standard therapy at age 5 years , flexible bronchoscopy with BAL can not be recommended for the routine management of preschool children with CF on the basis of overall cost savings .


Recent research has investigated the use of ultrasound ( US ) for confirming endotracheal tube ( ETT ) placement with varying techniques , accuracies , and challenges .


Our objective was to evaluate the accuracy of a novel , simplified , four-step ( 4S ) technique .


We conducted a blinded , randomized trial of the 4S technique utilizing an adult human cadaver model .


ETT placement was randomized to tracheal or esophageal location .


Three US experts and 45 emergency medicine residents ( EMR ) performed a total of 150 scans .


The primary outcome was the overall sensitivity and specificity of both experts and EMRs to detect location of ETT placement .


Secondary outcomes included a priori subgroup comparison of experts and EMRs for thin and obese cadavers , time to detection , and level of operator confidence .


Experts had a sensitivity of 100 % ( 95 % CI = 72 % to 100 % ) and specificity of 100 % ( 95 % CI = 77 % to 100 % ) on thin , and a sensitivity of 93 % ( 95 % CI = 66 % to 100 % ) and specificity of 100 % ( 95 % CI = 75 % to 100 % ) on obese cadavers .


EMRs had a sensitivity of 91 % ( 95 % CI = 69 % to 98 % ) and of specificity 96 % ( 95 % CI = 76 % to 100 % ) on thin , and a sensitivity of 100 % ( 95 % CI = 82 % to 100 % ) specificity of 48 % ( 95 % CI = 27 % to 69 % ) on obese cadavers .


The overall mean time to detection was 17 seconds ( 95 % CI = 13 seconds to 20 seconds , range : 2 to 63 seconds ) for US experts and 29 seconds ( 95 % CI = 25 seconds to 33 seconds ; range : 6 to 120 seconds ) for EMRs .


There was a statistically significant decrease in the specificity of this technique on obese cadavers when comparing the EMRs and experts , as well as an increased overall time to detection among the EMRs .


The simplified 4S technique was accurate and rapid for US experts .


Among novices , the 4S technique was accurate in thin , but appears less accurate in obese cadavers .


Further studies will determine optimal teaching time and accuracy in emergency department patients .


Uncertainty remains about the efficacy of folic acid therapy for the primary prevention of stroke because of limited and inconsistent data .


To test the primary hypothesis that therapy with enalapril and folic acid is more effective in reducing first stroke than enalapril alone among Chinese adults with hypertension .


The China Stroke Primary Prevention Trial , a randomized , double-blind clinical trial conducted from May 19 , 2008 , to August 24 , 2013 , in 32 communities in Jiangsu and Anhui provinces in China .


A total of 20,702 adults with hypertension without history of stroke or myocardial infarction ( MI ) participated in the study .


Eligible participants , stratified by MTHFR C677T genotypes ( CC , CT , and TT ) , were randomly assigned to receive double-blind daily treatment with a single-pill combination containing enalapril , 10 mg , and folic acid , 0.8 mg ( n = 10,348 ) or a tablet containing enalapril , 10 mg , alone ( n = 10,354 ) .


The primary outcome was first stroke .


Secondary outcomes included first ischemic stroke ; first hemorrhagic stroke ; MI ; a composite of cardiovascular events consisting of cardiovascular death , MI , and stroke ; and all-cause death .


During a median treatment duration of 4.5 years , compared with the enalapril alone group , the enalapril-folic acid group had a significant risk reduction in first stroke ( 2.7 % of participants in the enalapril-folic acid group vs 3.4 % in the enalapril alone group ; hazard ratio [ HR ] , 0.79 ; 95 % CI , 0.68-0 .93 ) , first ischemic stroke ( 2.2 % with enalapril-folic acid vs 2.8 % with enalapril alone ; HR , 0.76 ; 95 % CI , 0.64-0 .91 ) , and composite cardiovascular events consisting of cardiovascular death , MI , and stroke ( 3.1 % with enalapril-folic acid vs 3.9 % with enalapril alone ; HR , 0.80 ; 95 % CI , 0.69-0 .92 ) .


The risks of hemorrhagic stroke ( HR , 0.93 ; 95 % CI , 0.65-1 .34 ) , MI ( HR , 1.04 ; 95 % CI , 0.60-1 .82 ) , and all-cause deaths ( HR , 0.94 ; 95 % CI , 0.81-1 .10 ) did not differ significantly between the 2 treatment groups .


There were no significant differences between the 2 treatment groups in the frequencies of adverse events .


Among adults with hypertension in China without a history of stroke or MI , the combined use of enalapril and folic acid , compared with enalapril alone , significantly reduced the risk of first stroke .


These findings are consistent with benefits from folate use among adults with hypertension and low baseline folate levels .


clinicaltrials.gov Identifier : NCT00794885 .


To establish whether there was a difference in health-related quality of life ( HRQoL ) in people with chronic musculoskeletal disorders ( PwCMSKD ) after participating in a multimodal physiotherapy program ( MPP ) either two or three sessions a week .


Total of 114 PwCMSKD participated in this prospective randomised controlled trial .


An individualised MPP , consisting of exercises for mobility , motor-control , muscle strengthening , cardiovascular training , and health education , was implemented either twice a week ( G2 : n = 58 ) or three times a week ) ( G3 : n = 56 ) for 1 year .


HRQoL physical and mental health state ( PHS/MHS ) , Roland Morris disability Questionnaire ( RMQ ) , Neck-Disability-Index ( NDI ) and Western Ontario and McMaster Universities ' Arthritis Index ( WOMAC ) were used to measure outcomes of MPP for people with chronic low back pain , chronic neck pain and osteoarthritis , respectively .


Measures were taken at baseline , 8 weeks ( 8 w ) , 6 months ( 6m ) , and 1 year ( 1y ) after starting the programme .


No statistically significant differences were found between the two groups ( G2 and G3 ) , except in NDI at 8 w ( -3.34 , ( CI 95 % : -6.94 / 0.84 , p = 0.025 ( scale 0-50 ) ) .


All variables showed improvement reaching the following values ( from baseline to 1y ) G2 : PHS : 57.72 ( baseline : 41.17 ; ( improvement : 16.55 % ) , MHS : 74.51 ( baseline : 47.46 , 27.05 % ) , HRQoL 0.90 ( baseline : 0.72 , 18 % ) ) , HRQoL-VAS 84.29 ( baseline : 58.04 , 26.25 % ) , RMQ 4.15 ( baseline : 7.85 , 15.42 % ) , NDI 3.96 ( baseline : 21.87 , 35.82 % ) , WOMAC 7.17 ( baseline : 25.51 , 19.10 % ) .


G3 : PHS : 58.64 ( baseline : 39.75 , 18.89 % ) , MHS : 75.50 ( baseline : 45.45 , ( 30.05 % ) , HRQoL 0.67 ( baseline : 0.88 , 21 % ) , HRQoL-VAS 86.91 ( baseline : 52.64 , 34.27 % ) , RMQ 4.83 ( baseline : 8.93 , 17.08 % ) , NDI 4.91 ( baseline : 23.82 , 37.82 % ) , WOMAC 6.35 ( baseline : 15.30 , 9.32 % ) .


No significant differences between the two groups were found in the outcomes of a MPP except in the NDI at 8 weeks , but both groups improved in all variables during the course of 1 year under study .


Implications for Rehabilitation A multimodal physiotherapy program ( MPP ) improves quality of life , overall health , and function in people with chronic musculoskeletal disease after an intervention of short , medium and long term .


This implies that twice a week MPP for people with chronic musculoskeletal pain has comparable results to three times a week provision and therefore may have implications in saving resources and cost for patients and service providers without compromising the outcomes of treatment .


These results can be considered not only for therapists , but also for managers who offer the services to optimise the balance cost-effectiveness of the proposed interventions .


The beneficial role of exercise as a treatment approach in Huntington 's disease ( HD ) has support from both preclinical work and small-scale studies ; however , there have been no controlled studies of gym-based exercise in people with HD .


This phase 2 randomized trial ( ISRCTN 59910670 ) assessed feasibility , safety , acceptability , and benefit of a structured exercise program .


Thirty-one participants ( 16 men ; mean [ SD ] age = 50.4 [ 11.4 ] years ) were randomly allocated to intervention ( n = 16 ) or control group ( usual care ; n = 15 ) .


The intervention entailed a weekly supervised gym session of stationary cycling and resistance exercises , and a twice weekly independent home-based walking program .


Retention and adherence rates and adverse events were recorded .


Acceptability was determined from subjective reports of tolerability and physiological measures recorded during the gym sessions .


Assessment of benefit included measures of physical abilities , disease severity , and quality of life ( 36-Item Short Form Health Survey ) .


Analysis of covariance was used to test outcomes of interest .


The retention rate was 81 % ( 9 of the 11 individuals who started the intervention completed it ) and of the 9 who completed the program , 7 attended more than 75 % ( 9/12 ) of the gym sessions .


There were no related adverse events and the intervention was well tolerated by most participants .


The between-group effect estimate for the Mental Component Summary score of the 36-Item Short Form Health Survey ( n = 9 ; intervention , n = 13 ; control ) was 7 ( 95 % CI : 0.4-13 .7 ) Moderate effect sizes for cognitive outcomes and measures of walking were also observed .


Observed effect sizes for clinical outcomes suggest the structured exercise program has benefit for persons with HD ; larger scale trials are warranted.Video Abstract available ( see Video , Supplemental Digital Content 1 , http://links.lww.com/JNPT/A60 ) for more insights from the authors .


To optimize positive outcomes , the design of new pharmacy services should consider the preferences of consumers with chronic condition ( s ) and their carers .


( i ) To evaluate the relative importance of community pharmacy service characteristics , from the perspective of consumers with chronic condition ( s ) and carers ; ( ii ) To compare consumer and carer preferences to health professional beliefs about ideal service characteristics for consumers .


A discrete choice experiment was completed by consumers with chronic condition ( s ) and/or carers ( n = 602 ) and health professionals ( n = 297 ) , recruited from four regions in Australia .


Participants were each randomized to one survey version containing four ( from a total 72 ) different choices between two new pharmacy services .


Consumer and carer participants were also given an ` opt out ' alternative of current service .


Each service was described using six attributes related to pharmacy service characteristics : continued medicines supply , continuity and coordinated care , location , medication management , education and information , and cost .


Consumers and carers placed highest priority on continued medicines supply by a pharmacist for regular and symptom flare up medicines ( 100 priority points ) , a pharmacy located within a ` one-stop ' health center ( 61 points ) and home delivery of medicines ( 52 points ) .


Although continuedmedicines supply was most important for consumers and carers , pharmacy location was perceivedby health professionals to be the most important characteristic for consumers .


Participants were less inclined to choose new services if their current pharmacy offered high quality services thatwere person-centered , easy to access and responsive to their needs .


Younger , more highly educated and employed participants , and those with established condition ( s ) were more likely to choose new services .


Person-centered care is a fundamental tenet for pharmacy services .


The provision of continued medicines supply ( e.g. through pharmacist prescribing ) , convenient and coordinated care delivered through a one stop health centre , and home delivery of medicines , should be prioritized when planning pharmacy services to best assist consumers to manage chronic conditions .


Farm youth continue to experience high rates of injury and deaths as a result of agricultural activities .


Farm machinery , especially tractors , is the most common cause of casualties to youth .


A Roll-Over Protection Structure ( ROPS ) along with a fastened seatbelt can prevent almost all injuries and fatalities from tractor overturns .


Despite this knowledge , the use of seatbelts by farmers on ROPS tractors remains low .


This study treats farm safety as a family issue and builds on the central role of parents as teachers and role models of farm safety for youth .


This research study used a longitudinal , repeated-measures , randomized-control design in which youth 10-19years of age were randomly assigned to either of two intervention groups ( parent-led group and staff-led group ) or the control group .


Fathers in the parent-led group were less likely to operate ROPS tractors without a seatbelt compared with other groups .


They were more likely to have communicated with youth about the importance of wearing seatbelts on ROPS tractors .


Consequently , youth in the parent-led group were less likely to operate a ROPS tractor without a seatbelt than the control group at post-test .


This randomized control trial supports the effectiveness of a home-based , father-led farm safety intervention as a promising strategy for reducing youth as well as father-unsafe behaviors ( related to tractor seatbelts ) on the farm .


This intervention appealed to fathers ' strong motivation to practice tractor safety for the sake of their youth .


Involving fathers helped change both father as well as youth unsafe tractor-seatbelt behaviors .


Several studies have confirmed dramatic changes in skin surface parameters during the winter months .


Although there are many studies supporting the positive effects of topical treatment , there are no published studies demonstrating the effects of oral supplementation in the prevention of negative skin changes during winter .


The purpose of this study was to evaluate the efficacy of an oral micronutrient supplement in preventing the negative effects of winter weather on skin quality using noninvasive biometrologic instruments .


This study included 80 healthy female volunteers aged 35-55 years with phototype II-IV skin .


Randomization was balanced .


Two tablets of a micronutrient supplement ( Perfectil Platinum ) or placebo were administered once daily for 4 months .


The volunteers were examined at baseline , after 4 months , and 6 weeks after termination of treatment ( month 5.5 ) .


The evaluation included skin microrelief by Visioscan as the main outcome , and the secondary outcomes were results on standard macrophotography , skin tension by Reviscometer , skin high-frequency ultrasound , and self-assessment .


For all pseudoroughness and microrelief indicators , there was a significant increase from baseline to month 4 in the placebo group ( P < 0.05 ) but no change in the active group .


Descriptive statistics for the mean minimum , mean maximum , and minimum to maximum ratio on the nonexposed study zone showed a significant and dramatic difference between baseline and month 4 and between baseline and month 5.5 ( P < 0.05 ) in the active group , indicating decreasing anisotropy of the skin .


High-frequency ultrasound on the exposed study zone revealed that skin thickness was significantly decreased in the placebo group during winter but was stable in the treated group ( P < 0.01 ) .


The photography scaling and self-assessment questionnaire revealed no significant changes in either group .


These results indicate that the skin is prone to seasonal changes during winter , particularly in exposed areas .


The data also indicate that oral supplementation can be a safe treatment , with no serious side effects , and may prevent or even eliminate the negative effects of winter on the skin .


To compare the effectiveness of in vitro fertilisation with single embryo transfer or in vitro fertilisation in a modified natural cycle with that of intrauterine insemination with controlled ovarian hyperstimulation in terms of a healthy child .


Multicentre , open label , three arm , parallel group , randomised controlled non-inferiority trial .


17 centres in the Netherlands .


Couples seeking fertility treatment after at least 12 months of unprotected intercourse , with the female partner aged between 18 and 38 years , an unfavourable prognosis for natural conception , and a diagnosis of unexplained or mild male subfertility .


Three cycles of in vitro fertilisation with single embryo transfer ( plus subsequent cryocycles ) , six cycles of in vitro fertilisation in a modified natural cycle , or six cycles of intrauterine insemination with ovarian hyperstimulation within 12 months after randomisation .


The primary outcome was birth of a healthy child resulting from a singleton pregnancy conceived within 12 months after randomisation .


Secondary outcomes were live birth , clinical pregnancy , ongoing pregnancy , multiple pregnancy , time to pregnancy , complications of pregnancy , and neonatal morbidity and mortality


602 couples were randomly assigned between January 2009 and February 2012 ; 201 were allocated to in vitro fertilisation with single embryo transfer , 194 to in vitro fertilisation in a modified natural cycle , and 207 to intrauterine insemination with controlled ovarian hyperstimulation .


Birth of a healthy child occurred in 104 ( 52 % ) couples in the in vitro fertilisation with single embryo transfer group , 83 ( 43 % ) in the in vitro fertilisation in a modified natural cycle group , and 97 ( 47 % ) in the intrauterine insemination with controlled ovarian hyperstimulation group .


This corresponds to a risk , relative to intrauterine insemination with ovarian hyperstimulation , of 1.10 ( 95 % confidence interval 0.91 to 1.34 ) for in vitro fertilisation with single embryo transfer and 0.91 ( 0.73 to 1.14 ) for in vitro fertilisation in a modified natural cycle .


These 95 % confidence intervals do not extend below the predefined threshold of 0.69 for inferiority .


Multiple pregnancy rates per ongoing pregnancy were 6 % ( 7/121 ) after in vitro fertilisation with single embryo transfer , 5 % ( 5/102 ) after in vitro fertilisation in a modified natural cycle , and 7 % ( 8/119 ) after intrauterine insemination with ovarian hyperstimulation ( one sided P = 0.52 for in vitro fertilisation with single embryo transfer compared with intrauterine insemination with ovarian hyperstimulation ; one sided P = 0.33 for in vitro fertilisation in a modified natural cycle compared with intrauterine insemination with controlled ovarian hyperstimulation ) .


In vitro fertilisation with single embryo transfer and in vitro fertilisation in a modified natural cycle were non-inferior to intrauterine insemination with controlled ovarian hyperstimulation in terms of the birth of a healthy child and showed comparable , low multiple pregnancy rates.Trial registration Current Controlled Trials ISRCTN52843371 ; Nederlands Trial Register NTR939 .


The comparative risks and benefits of early compared with delayed cord clamping in the preterm neonate remain unclear .


Our objective was to evaluate the short-term effects of delayed clamping of the umbilical cord in preterm neonates .


We conducted a randomized controlled trial comparing immediate with delayed cord clamping among preterm neonates born between 24 and 34 weeks of gestation .


The primary study outcome was the need for blood transfusion .


To detect a 33 % reduction in this outcome ( from 65 to 43.5 % ) with a two-tailed of 0.5 and of 0.8 required 178 patients equally divided into two groups .


A total of 200 women were randomized , 99 to the delayed and 101 to the immediate clamp group .


The groups were similar with respect to baseline characteristics .


The mean gestational age at delivery was 30.83.1 weeks in the delayed compared with 30.72.8 weeks in the immediate clamp group ( P = .64 ) .


There was no statistically significant difference between groups with regard to the need for blood transfusion : 25 of 99 ( 25.3 % ) in the delayed cord clamp group received one or more blood transfusion compared with 24 of 101 ( 23.7 % ) in the immediate clamp group ( P = .8 ) .


The rates of various neonatal outcomes including respiratory distress syndrome , periventricular leukomalacia , necrotizing enterocolitis , anemia of prematurity , and neonatal morality did not differ significantly between the groups .


However , the mean initial hemoglobin ( 17.42.5 compared with 16.32.3 g/dL , P = .001 ) and hematocrit ( 51.37.3 compared with 47.47.3 , P = .001 ) was significantly higher in the delayed group .


In the delayed clamp group , 11.1 % ( 11/99 ) of neonates had intraventricular hemorrhage compared with 19.8 % ( 20/101 ) in the immediate clamp group ( P = .09 ) .


Delayed cord clamping for 30 seconds did not decrease the need for blood transfusion among preterm neonates .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT00579839 .


Acute hamstring re-injuries are common and hard to predict .


The aim of this study was to investigate the association between clinical and imaging findings and the occurrence of hamstring re-injuries .


We obtained baseline data ( clinical and MRI findings ) of athletes who sustained an acute hamstring injury within 5days of initial injury .


We also collected data of standardised clinical tests within 7days after return to play ( RTP ) .


The number of re-injuries was recorded within 12months .


We analysed the association between the possible predictive variables and re-injuries with a multivariate Cox proportional-hazards regression model .


Eighty patients were included at baseline and 64 patients could be included in the final analysis because data after RTP were not available in 16 cases .


There were 17 re-injuries ( 27 % ) .


None of the baseline MRI findings were univariately associated with re-injury .


A higher number of previous hamstring injuries ( adjusted OR ( AOR ) 1.33 ; 95 % CI 1.11 to 1.61 ) , more degrees of active knee extension deficit after RTP ( AOR 1.13 ; 95 % CI 1.03 to 1.25 ) , isometric knee flexion force deficit at 15 after RTP ( AOR 1.04 ; 95 % CI 1.01 to 1.07 ) and presence of localised discomfort on hamstring palpation after RTP ( AOR 3.95 ; 95 % CI 1.38 to 11.37 ) were significant independent predictors of re-injury .


Athletes with localised discomfort on hamstring palpation just after RTP were consequently almost four times more likely to sustain a re-injury .


The number of previous hamstring injuries , active knee extension deficit , isometric knee flexion force deficit at 15 and presence of localised discomfort on palpation just after RTP are associated with a higher hamstring re-injury rate .


None of the baseline MRI parameters was a predictor of hamstring re-injury .


ClinicalTrial.gov number NCT01812564 .


Intra-arterial treatment ( IAT ) in patients with acute ischemic stroke ( AIS ) can be performed with or without general anesthesia ( GA ) .


Previous studies suggested that IAT without the use of GA ( non-GA ) is associated with better clinical outcome .


Nevertheless , no consensus exists about the anesthetic management during IAT of AIS patients .


This study investigates the association between type of anesthesia and clinical outcome in a large cohort of patients with AIS treated with IAT .


All consecutive patients with AIS of the anterior circulation who received IAT between 2002 and 2013 in 16 Dutch hospitals were included in the study .


Primary outcome was functional outcome on the modified Rankin Scale at discharge .


Difference in primary outcome between GA and non-GA was estimated using multiple ordinal regression analysis , adjusting for age , stroke severity , occlusion of the internal carotid artery terminus , previous stroke , atrial fibrillation , and diabetes mellitus .


Three hundred forty-eight patients were included in the analysis ; 70 patients received GA and 278 patients did not receive GA. .


Non-GA was significantly associated with good clinical outcome ( odds ratio 2.1 , 95 % confidence interval 1.02-4 .31 ) .


After adjusting for prespecified prognostic factors , the point estimate remained similar ; statistical significance , however , was lost ( odds ratio 1.9 , 95 % confidence interval 0.89-4 .24 ) .


Our study suggests that patients with AIS of the anterior circulation undergoing IAT without GA have a higher probability of good clinical outcome compared with patients treated with general anesthesia .


Restenosis is a limitation of endovascular interventions performed in the superficial femoral artery ( SFA ) .


Preclinical studies have demonstrated that the perivascular delivery of tissue-engineered allogeneic aortic endothelial cells ( PVS-10200 ) reduced stenosis in porcine models of SFA revascularization .


The purpose of this study was to investigate the safety and feasibility of percutaneous PVS-10200 delivery after angioplasty and stenting in the SFA of patients with peripheral artery disease .


In this phase I open-label trial , 21 patients ( average lesion length of 10.10 2.36 cm and 70 % stenosis ) were treated with PVS-10200 : 11 in a low-dose cohort ( cohort A ) and 10 in a high-dose cohort ( cohort B ) .


The primary objective was to demonstrate the safety ( incidence of major adverse events ) of PVS-10200 within 4 weeks after surgery .


Secondary end points included assessments of resting ankle-brachial index ( ABI ) in the treated leg , Fontaine class , and time to target lesion revascularization ( TLR ) .


No patient had a major adverse event within 4 weeks .


One patient required a limb amputation at 30 weeks .


At 48 weeks , cohort A and cohort B patients maintained a 37 % and 62 % increase in ABI compared with baseline , respectively ; 70 % of cohort A and 78 % of cohort B improved by 1 Fontaine classification stage , and the TLR rate was 39 % for cohort A and 20 % for cohort B.


Percutaneous local delivery of PVS-10200 is a well-tolerated and novel therapeutic approach that may be a suitable treatment for patients after endovascular intervention of the SFA .


Larger randomized trials are needed to determine if PVS-10200 can improve ABI and reduce TLR rates .


Prior studies have demonstrated a significant gap between guideline-based recommendations and clinical practice in the management of acute ischemic stroke ( AIS ) in China .


This study implements a targeted multifaceted quality improvement intervention in AIS patients and identifies the feasibility and efficacy of this intervention .


This is a multicenter , 2-arm , open-label , cluster-randomized trial involving 40 clusters ( hospitals ) from China National Network of Stroke Research .


Hospitals are randomized to receive a targeted multifaceted quality improvement intervention ( experimental group ) or routine standard of care ( control group ) .


The multifaceted intervention includes an evidence-based clinical pathway , written care protocols , a quality coordinator , and a monitoring and feedback system of performance measures .


The number of enrolled patients in the trial will be 4,800 .


Primary outcome is the measure of the adherence to AIS evidence-based performance measures including the composite measure ( defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients ) and the all-or-none measure ( defined as the proportion of eligible patients who receive all of the performance measure interventions for which they are eligible ) .


Secondary patient outcomes include inhospital death ; a new vascular event ; disability ; and all-cause death at 3 , 6 , and 12 months after initial symptom onset .


All analyses will be performed according to the intention-to-treatment principle and accounted for clustering using generalized estimating equations .


If proven effective , this targeted multifaceted intervention model will be extended nationwide as a model to bridge the evidence-based gap in the AIS management in China .


Administration of secretin improves noninvasive imaging of the pancreatic duct with magnetic resonance cholangiopancreatography ( MRCP ) .


We performed a large prospective study to investigate whether synthetic human secretin ( RG1068 ) - stimulated MRCP detects pancreatic duct abnormalities with higher levels of sensitivity than MRCP .


We performed a phase 3 , multicenter , baseline-controlled study of patients with acute or acute recurrent pancreatitis who were scheduled to undergo endoscopic retrograde cholangiopancreatography ( ERCP ) between March 26 , 2008 , and October 28 , 2009 .


Patients underwent a baseline MRCP that was immediately followed by administration of RG1068 and repeat MRCP and then underwent ERCP within 30 days ; they were followed up for 30 days .


MRCP and ERCP images were read centrally by 3 radiologists and 2 endoscopists , respectively , who were all independent and blinded ; pancreatic duct abnormalities were evaluated .


The accuracy of MRCP was evaluated using ERCP as the standard .


In total , 258 patients were enrolled in the study ; 251 MRCP image sets were assessed , and 236 patients had evaluable ERCPs .


Pancreatic duct abnormalities were observed in 60.2 % of ERCP images .


All radiologists identified duct abnormalities in RG1068-cin MRCP image sets with significantly higher levels of sensitivity ( P < .0001 ) than in images from MRCP , with minimal loss of specificity .