The aim of this study was to compare short and midterm results of open reduction and plate fixation with those of intramedullary nailing for displaced midshaft clavicular fractures .


A multicenter , randomized controlled trial was performed in four different hospitals .


The study included 120 patients , eighteen to sixty-five years of age , treated with either open reduction and plate fixation ( n = 58 ) or intramedullary nailing ( n = 62 ) .


Preoperative and postoperative shoulder function scores and complications were documented until one year postoperatively .


Significance was set at p < 0.05 .


No significant differences in the Disabilities of the Arm , Shoulder and Hand ( DASH ) or Constant-Murley score ( 3.0 and 96.0 points for the plate group and 5.6 and 95.5 points for the nailing group ) were noted between the two surgical interventions at six months postoperatively .


Until six months after the surgery , the plate-fixation group experienced less disability than the nailing group as indicated by the area under the curve of the DASH scores for this time period ( p = 0.02 ) .


The mean numbers of complications per patient , irrespective of their severity , were similar between the plate-fixation ( 0.67 ) and nailing ( 0.74 ) groups ( p = 0.65 ) .


The patients in the plate-fixation group recovered faster than the patients in the intramedullary nailing group , but the groups had similar results at six months postoperatively and the time of final follow-up .


The rate of complications requiring revision surgery was low .


Implant-related complications occurred frequently and could often be treated by implant removal .


To evaluate the effect of formulation and a high-fat meal on the pharmacokinetics of orally administered lenvatinib ( E7080 ) .


Lenvatinib 10-mg capsule and tablet .


Pharmacokinetics and safety of a single 10-mg lenvatinib dose were evaluated in healthy subjects in two randomized , two-period , crossover , phase 1 , bioavailability trials .


The first compared a new capsule formulation with an older tablet formulation ( n = 20 subjects ) ; the second evaluated the influence of a standard high-fat meal on the relative bioavailability of the capsule formulation ( n = 16 subjects ) .


Geometric least squares mean ratios of AUC0 - , maximum observed concentration ( Cmax ) , and AUC0-t were determined .


tmax , tlag ( food effect only ) , and t1/2 , z were also calculated , and descriptive statistics were provided .


A total of 36 healthy volunteers were enrolled in the two studies ( mean ages 29 and 33 years ) .


In the formulation study , AUC0 - and AUC0-t of the capsule formulation were ~ 10 % less than the tablet formulation , and Cmax for the capsule formulation was ~ 14 % lower .


90 % Confidence intervals ( CIs ) for both AUCs were within the 80 - 125 % CI , which is generally considered to denote bioequivalence , while the lower bound of the interval for Cmax was 79.8 % .


tmax and t1/2 , z were comparable .


For the capsule formulation , the mean ( % CV ) t1/2 , z was 27.6 hours ( 27.3 ) and the median ( range ) tmax was 2.0 hours ( 2 - 4 ) .


In the food effect study , lenvatinib 's AUC0 - and AUC0-t increased ~ 6 % and 4 % with the high-fat meal .


Cmax following a high-fat meal was 5 % lower than following administration in the fasted state .


Administration with food delayed lenvatinib 's tmax ( 2 vs. 4 hours ) .


90 % CIs for AUCs were within the 80 - 125 % CI , while the CI for Cmax was 72.1 - 126.4 % .


The single 10-mg dose demonstrated an acceptable tolerability profile ; treatment-emergent adverse events occurred in 9 subjects ( 25 % ) overall and were typically mild in severity .


These studies show that a new capsule formulation produces slightly lower exposure ( ~ 10 - 14 % ) to lenvatinib compared with the original tablet formulation , and that oral administration with a high-fat meal does not significantly affect exposure , although absorption is delayed .


Thus , lenvatinib can be administered without regard to the timing of meals .


To study the clinical effectiveness and safety of nasal intermittent positive pressure ventilation ( NIPPV ) in the initial treatment of neonatal respiratory distress syndrome ( NRDS ) and the initial setting of NIPPV parameters .


One hundred neonates with NRDS were divided into NIPPV group ( n = 50 ) and nasal continuous positive airway pressure ( NCPAP ) group ( n = 50 ) .


A randomized controlled study was conducted to compare the effectiveness of NIPPV versus NCPAP in the initial treatment of NRDS from the following aspects : reducing CO2 retention , improving oxygenation , reducing second endotracheal intubation and second use of pulmonary surfactant ( PS ) , reducing the duration of invasive respiratory support , reducing the duration of oxygen use , and reducing the incidence of air leak , abdominal distension and ventilator-associated pneumonia .


After 1 and 6 hours of noninvasive respiratory support , the NIPPV group was superior to the NCPAP group with respect to the reduction in CO2 retention and improvement in oxygenation ( P < 0.05 ) ; in addition , compared with the NCPAP group , the NIPPV group had significantly lower rates of second endotracheal intubation and second PS use , significantly shorter duration of invasive respiratory support and time of FiO2 > 0.21 , and significantly lower incidence of apnea and ventilator-associated pneumonia ( P < 0.05 ) ; there were no significant differences in the incidence of air leak and abdominal distention between the two groups .


NIPPV is effective and safe in the initial treatment of NRDS and holds promise for clinical application .


Patients are increasingly being admitted with chronic atrial fibrillation , and disease-specific management might reduce recurrent admissions and prolong survival .


However , evidence is scant to support the application of this therapeutic approach .


We aimed to assess SAFETY -- a management strategy that is specific to atrial fibrillation .


We did a pragmatic , multicentre , randomised controlled trial in patients admitted with chronic , non-valvular atrial fibrillation ( but not heart failure ) .


Patients were recruited from three tertiary referral hospitals in Australia .


335 participants were randomly assigned by computer-generated schedule ( stratified for rhythm or rate control ) to either standard management ( n = 167 ) or the SAFETY intervention ( n = 168 ) .


Standard management consisted of routine primary care and hospital outpatient follow-up .


The SAFETY intervention comprised a home visit and Holter monitoring 7-14 days after discharge by a cardiac nurse with prolonged follow-up and multidisciplinary support as needed .


Clinical reviews were undertaken at 12 and 24 months ( minimum follow-up ) .


Coprimary outcomes were death or unplanned readmission ( both all-cause ) , measured as event-free survival and the proportion of actual versus maximum days alive and out of hospital .


Analyses were done on an intention-to-treat basis .


The trial is registered with the Australian New Zealand Clinical Trials Registry ( ANZCTRN 12610000221055 ) .


During median follow-up of 905 days ( IQR 773-1050 ) , 49 people died and 987 unplanned admissions were recorded ( totalling 5530 days in hospital ) .


127 ( 76 % ) patients assigned to the SAFETY intervention died or had an unplanned readmission ( median event-free survival 183 days [ IQR 116-409 ] ) and 137 ( 82 % ) people allocated standard management achieved a coprimary outcome ( 199 days [ 116-249 ] ; hazard ratio 097 , 95 % CI 076-123 ; p = 0851 ) .


Patients assigned to the SAFETY intervention had 995 % maximum event-free days ( 95 % CI 993-997 ) , equating to a median of 900 ( IQR 767-1025 ) of 937 maximum days alive and out of hospital .


By comparison , those allocated to standard management had 992 % ( 95 % CI 988-994 ) maximum event-free days , equating to a median of 860 ( IQR 752-1047 ) of 937 maximum days alive and out of hospital ( effect size 022 , 95 % CI 021-023 ; p = 0039 ) .


A post-discharge management programme specific to atrial fibrillation was associated with proportionately more days alive and out of hospital ( but not prolonged event-free survival ) relative to standard management .


Disease-specific management is a possible strategy to improve poor health outcomes in patients admitted with chronic atrial fibrillation .


National Health and Medical Research Council of Australia .


To examine the effects of using vinyl isolation bags or polyethylene wrap for the prevention of postnatal hypothermia in preterm infants at 32 weeks gestation .


A prospective , randomized controlled trial .


The neonatal intensive care unit ( NICU ) of the Istanbul Faculty of Medicine in Turkey .


Fifty-nine preterm infants .


Participants were randomly assigned to either the vinyl isolation-bag experimental group ( n = 22 ) or the polyethylene-wrap control group ( n = 37 ) .


Infant body temperature was measured at four time points after birth .


Loss of body temperature was significantly less in the vinyl isolation-bag group during the first 60 minutes after birth ( p = .041 ) .


Body temperature decreased by 1.41 1.65 C in the vinyl isolation-bag group and 2.75 1.68 C in the polyethylene wrap group .


Body temperature was significantly less in the polyethylene wrap group compared to the vinyl isolation-bag group at birth to 60 minutes ( p = .004 ) .


Wrapping preterm infants of gestational age 32 weeks in vinyl bags immediately after birth is associated with lower incidences of hypothermia .


Previous studies have suggested the potential importance of three DPYD variants ( DPYD * 2A , D949V , and I560S ) with increased 5-FU toxicity .


Their individual associations , however , in 5-FU-based combination therapies , remain controversial and require further systematic study in a large patient population receiving comparable treatment regimens with uniform clinical data .


We genotyped 2886 stage III colon cancer patients treated adjuvantly in a randomized phase III trial with FOLFOX or FOLFIRI , alone or combined with cetuximab , and tested the individual associations between functionally deleterious DPYD variants and toxicity .


Logistic regressions were used to assess univariate and multivariable associations .


All statistical tests were two-sided .


In 2594 patients with complete adverse event ( AE ) data , the incidence of grade 3 or greater 5FU-AEs in DPYD * 2A , I560S , and D949V carriers were 22/25 ( 88.0 % ) , 2/4 ( 50.0 % ) , and 22/27 ( 81.5 % ) , respectively .


Statistically significant associations were identified between grade 3 or greater 5FU-AEs and both DPYD * 2A ( odds ratio [ OR ] = 15.21 , 95 % confidence interval [ CI ] = 4.54 to 50.96 , P < .001 ) and D949V ( OR = 9.10 , 95 % CI = 3.43 to 24.10 , P < .001 ) variants .


Statistical significance remained after adjusting for multiple variables .


The DPYD * 2A variant statistically significantly associated with the specific AEs nausea/vomiting ( P = .007 ) and neutropenia ( P < .001 ) , whereas D949V statistically significantly associated with dehydration ( P = .02 ) , diarrhea ( P = .003 ) , leukopenia ( P = .002 ) , neutropenia ( P < .001 ) , and thrombocytopenia ( P < .001 ) .


Although two patients with I560S had grade3 5FU-AEs ; a statistically significant association could not be demonstrated because of its low frequency ( P = .48 ) .


In the largest study to date , statistically significant associations were found between DPYD variants ( DPYD * 2A and D949V ) and increased incidence of grade 3 or greater 5FU-AEs in patients treated with adjuvant 5-FU-based combination chemotherapy .


To compare structural knee joint changes in obese patients with knee osteoarthritis ( OA ) that after an intensive weight loss therapy were randomized to continuous dietetic support , a specialized knee exercise program , or ` no attention ' for 1 year .


192 obese individuals with knee OA underwent an intensive 16-week weight loss program with subsequent randomization to one of the three treatment groups .


Changes in cartilage loss , bone marrow lesions ( BMLs ) , synovitis , and effusion were assessed using semi quantitative assessments of magnetic resonance imaging ( MRI ) obtained at weeks 0 and 68 applying the BLOKS score .


During the 52 weeks maintenance period the continuous dietary maintenance group support on average gained 1.1 kg ( 95 % CI : -0.3:2.5 ) body mass , the exercise group gained 6.6 kg ( 95 % CI 5.4:7.8 ) and the no-attention group gained 4.8 kg ( 95 % CI : 2.9:6.7 ) .


There were no statistically significant between-group differences in changes in cartilage loss , synovitis or effusion at the follow-up ( analysis of covariance ; ANCOVA , P > 0.16 ) , while there was an increased number of medial tibiofemoral BMLs in the exercise group ( ANCOVA , P = 0.015 ) compared to both diet ( difference : -0.21 [ 95 % CI -0.40 : -0.03 ] ) and `` no attention '' ( difference : -0.26 [ 95 % CI -0.44 : -0.07 ] ) groups .


In this 1 year follow-up after weight-loss in obese knee OA patients , we found a potentially increased number of BMLs in the exercise group compared to the diet and no attention groups , with no between-group differences in changes in cartilage loss , synovitis or effusion .


These findings should be interpreted with caution for exercise compliance , MRI methodology and follow-up time .


( ClinicalTrials.gov identifier : NCT00655941 ) .


Stimulation and nutrition delivered through health programmes at a large scale could potentially benefit more than 200 million young children worldwide who are not meeting their developmental potential .


We investigated the feasibility and effectiveness of the integration of interventions to enhance child development and growth outcomes in the Lady Health Worker ( LHW ) programme in Sindh , Pakistan .


We implemented a community-based cluster-randomised effectiveness trial through the LHW programme in rural Sindh , Pakistan , with a 22 factorial design .


We randomly allocated 80 clusters ( LHW catchments ) of children to receive routine health and nutrition services ( controls ; n = 368 ) , nutrition education and multiple micronutrient powders ( enhanced nutrition ; n = 364 ) , responsive stimulation ( responsive stimulation ; n = 383 ) , or a combination of both enriched interventions ( n = 374 ) .


The allocation ratio was 1:20 ( ie , 20 clusters per intervention group ) .


The data collection team were masked to the allocated intervention .


All children born in the study area between April , 2009 , and March , 2010 , were eligible for enrolment if they were up to 25 months old without signs of severe impairments .


Interventions were delivered by LHWs to families with children up to 24 months of age in routine monthly group sessions and home visits .


The primary endpoints were child development at 12 and 24 months of age ( assessed with the Bayley Scales of Infant and Toddler Development , Third Edition ) and growth at 24 months of age .


Analysis was by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT007159636 .


1489 mother-infant dyads were enrolled into the study , of whom 1411 ( 93 % ) were followed up until the children were 24 months old .


Children who received responsive stimulation had significantly higher development scores on the cognitive , language , and motor scales at 12 and 24 months of age , and on the social-emotional scale at 12 months of age , than did those who did not receive the intervention .


Children who received enhanced nutrition had significantly higher development scores on the cognitive , language , and social-emotional scales at 12 months of age than those who did not receive this intervention , but at 24 months of age only the language scores remained significantly higher .


We did not record any additive benefits when responsive stimulation was combined with nutrition interventions .


Responsive stimulation effect sizes ( Cohen 's d ) were 06 for cognition , 07 for language , and 05 for motor development at 24 months of age ; these effect sizes were slightly smaller for the combined intervention group and were low to moderate for the enhanced nutrition intervention alone .


Children exposed to enhanced nutrition had significantly better height-for-age Z scores at 6 months ( p < 00001 ) and 18 months ( p = 002 ) than did children not exposed to enhanced nutrition .


Longitudinal analysis showed a small benefit to linear growth from enrolment to 24 months ( p = 0026 ) in the children who received the enhanced nutrition intervention .


The responsive stimulation intervention can be delivered effectively by LHWs and positively affects development outcomes .


The absence of a major effect of the enhanced nutrition intervention on growth shows the need for further analysis of mediating variables ( eg , household food security status ) that will help to optimise future nutrition implementation design .


UNICEF .


Multiple system atrophy is a complex neurodegenerative disorder for which no effective treatment exists .


We aimed to assess the effect of rasagiline on symptoms and progression of the parkinsonian variant of multiple system atrophy .


We did this randomised , double-blind , placebo-controlled trial between Dec 15 , 2009 , and Oct 20 , 2011 , at 40 academic sites specialised in the care of patients with multiple systemic atrophy across 12 countries .


Eligible participants aged 30 years or older with possible or probable parkinsonian variant multiple system atrophy were randomly assigned ( 1:1 ) , via computer-generated block randomisation ( block size of four ) , to receive either rasagiline 1 mg per day or placebo .


Randomisation was stratified by study centre .


The investigators , study funder , and personnel involved in patient assessment , monitoring , analysis and data management were masked to group assignment .


The primary endpoint was change from baseline to study end in total Unified Multiple System Atrophy Rating Scale ( UMSARS ) score ( parts I and II ) .


Analysis was by modified intention to treat .


The trial is registered with ClinicalTrials.gov , number NCT00977665 .


We randomly assigned 174 participants to the rasagiline group ( n = 84 ) or the placebo group ( n = 90 ) ; 21 ( 25 % ) patients in the rasagiline group and 15 ( 17 % ) in the placebo group withdrew from the study early .


At week 48 , patients in the rasagiline group had progressed by an adjusted mean of 72 ( SE 12 ) total UMSARS units versus 78 ( 11 ) units in those in the placebo group .


This treatment difference of -060 ( 95 % CI -368 to 247 ; p = 070 ) was not significant .


68 ( 81 % ) patients in the rasagiline group and 67 ( 74 % ) patients in the placebo group reported adverse events , and we recorded serious adverse events in 29 ( 35 % ) versus 23 ( 26 % ) patients .


The most common adverse events in the rasagiline group were dizziness ( n = 10 [ 12 % ] ) , peripheral oedema ( n = 9 [ 11 % ] ) , urinary tract infections ( n = 9 [ 11 % ] ) , and orthostatic hypotension ( n = 8 [ 10 % ] ) .


In this population of patients with the parkinsonian variant of multiple system atrophy , treatment with rasagiline 1 mg per day did not show a significant benefit as assessed by UMSARS .


The study confirms the sensitivity of clinical outcomes for multiple system atrophy to detect clinically significant decline , even in individuals with early disease .


Teva Pharmaceutical Industries and H Lundbeck A/S .


Ultravision is a new device that utilizes electrostatic precipitation to clear surgical smoke .


The aim was to evaluate its performance during laparoscopic cholecystectomy .


Patients undergoing laparoscopic cholecystectomy were randomized into `` active ( device on ) '' or `` control ( device off ) . ''


Three operating surgeons scored the percentage effective visibility and three reviewers scored the percentage of the procedure where smoke was present .


All assessors also used a 5-point scale ( 1 = imperceptible/excellent and 5 = very annoying/bad ) to rate visual impairment .


Secondary outcomes were the number of smoke-related pauses , camera cleaning , and pneumoperitoneum reductions .


Mean results are presented with 95 % confidence intervals ( CI ) .


In 30 patients ( active 13 , control 17 ) , the effective visibility was 89.2 % ( 83.3-95 .0 ) for active cases and 71.2 % ( 65.7-76 .7 ) for controls .


The proportion of the procedure where smoke was present was 41.1 % ( 33.8-48 .3 ) for active cases and 61.5 % ( 49.0-74 .1 ) for controls .


Operating surgeons rated the visual impairment as 2.2 ( 1.7-2 .6 ) for active cases and 3.2 ( 2.8-3 .5 ) for controls .


Reviewers rated the visual impairment as 2.3 ( 2.0-2 .5 ) for active cases and 3.2 ( 2.8-3 .7 ) for controls .


In the active group , 23 % of procedures were paused to allow smoke clearance compared to 94 % of control cases .


Camera cleaning was not needed in 85 % of active procedures and 35 % of controls .


The pneumoperitoneum was reduced in 0 % of active cases and 88 % of controls .


Ultravision improves visibility during laparoscopic surgery and reduces delays in surgery for smoke clearance and camera cleaning .


Propofol injection pain , despite various strategies , remains common and troublesome .


This study aimed to test the hypothesis that pretreatment with the combination of intravenous lidocaine and magnesium would have an additive effect on reducing propofol injection pain .


After institutional review board ( IRB ) approval and informed consent , we performed a prospective , double-blind , placebo-controlled , randomized trial .


Subjects were randomly assigned to pretreatment with either lidocaine ( 50mg ) , magnesium sulfate ( 0.25 mg ) , lidocaine ( 50mg ) plus magnesium sulfate ( 0.25 mg ) , or 0.9 % sodium chloride .


Following pretreatment , propofol ( 50mg ) was administered , and subjects were questioned regarding injection site pain and observed for behavioral signs of pain .


Two hundred subjects were enrolled and 158 subjects ( 39 placebo , 38 lidocaine , 44 magnesium sulfate , and 37 lidocaine plus magnesium sulfate ) received their assigned pretreatment intervention .


Intergroup baseline characteristics were similar .


The proportion of subjects reporting propofol injection pain was highest in those pretreated with magnesium sulfate ( 57 % ) , followed by those pretreated with placebo ( 46 % ) , lidocaine plus magnesium sulfate ( 41 % ) , and then lidocaine ( 29 % ; p = 0.011 ) .


When adjusted for age , gender , diabetes mellitus , chronic pain , tobacco use , and selective-serotonin reuptake inhibitor use , the pain response scale scores were significantly reduced by lidocaine pretreatment compared to magnesium sulfate and placebo ( p = 0.031 and p = 0.0003 , respectively ) .


In this double-blind , placebo-controlled , randomized trial , the combination of intravenous magnesium sulfate and lidocaine offered no additional benefit for the relief of propofol injection pain compared to intravenous lidocaine alone .


An improved , receptor-based understanding of the mechanism of propofol injection pain is still needed .


This study was designed to evaluate the outcomes of alcohol septal ablation ( ASA ) under multicenter and multinational conditions .


Data for 459 patients ( age 5713 years ) from nine European centers were prospectively collected and retrospectively analyzed .


ASA led to a significant reduction in outflow gradient ( PG ) and dyspnea [ median of PG from 88 ( 58-123 ) mm Hg to 21 ( 11-41 ) mm Hg ; median of NYHA class from 3 ( 2-3 ) to 1 ( 1-2 ) ; P < 0.01 ] .


The incidence of 3-month major adverse events ( death , electrical cardioversion for tachyarrhythmias , resuscitation ) and mortality was 2.8 % and 0.7 % , respectively .


Permanent pacemakers for post-ASA complete heart block were implanted in 43 patients ( 9 % ) .


Multivariate analysis identified higher amount of alcohol ( however , in generally low-dose procedures ) , higher baseline left ventricular ejection fraction and higher age as independent predictors of PG decrease 50 % .


The results of the first European multicenter and multinational study demonstrate that real-world early outcomes of ASA patients are better than was reported in observations from the first decade after ASA introduction .


Inability to read instructions on drug labels has been identified among the Malaysian population since 1990 's .


To assess the impact of font-enlarged and pictogram-incorporated labels used for long-term medications on patients ' adherence , comprehension and preferences .


Outpatient pharmacy in one of the major general hospitals across Northern Malaysia .


This was a three-arm , randomized controlled trial .


Outpatients with refill prescriptions of selected oral antihypertensive or antidiabetic medications were screened for eligibility .


They were randomly allocated with standard ( n = 35 ) , font-enlarged ( n = 40 ) or pictogram-incorporated ( n = 35 ) labels .


Assessment of baseline adherence scores using the 8-item Morisky Medication Adherence Scale , comprehension scores using a structured questionnaire and preferences was conducted upon recruitment .


Follow-up telephone interviews were conducted after 4 weeks .


The changes of patients ' adherence and comprehension scores and their preferences .


Within-group comparisons demonstrated an increase of total adherence scores after 4 weeks in all three groups ( mean changes 0.35 , 0.58 and 0.67 ; p = 0.029 , 0.013 and 0.011 , respectively ) .


The repeatedly measured total comprehension score of pictogram-incorporated label group was significantly higher than baseline ( mean change 0.37 , p = 0.010 ) .


Two intervention groups obtained significantly higher scores for few items in both adherence and comprehension measurements after 4 weeks as compared with baselines .


As indicated by F tests , three groups did not significantly differ in the changes of both total adherence and comprehension scores ( p = 0.573 and 0.069 , respectively ) with the subjects ' age adjusted .


Elderlies and those with a higher number of morbidity preferred pictogram-incorporated label over font-enlarged label .


We did not find a significant change of both adherence and comprehension levels after the introduction of modified medication labels .


However , on the basis of within-group comparisons , they may have positive influences on certain aspects of patients ' adherence and comprehension .


Variations in preferences may reflect the unique need of different subgroups in receiving written medication instructions .


The purpose of this article is to evaluate the efficacy of IV hyoscine butylbromide as a bowel relaxant and automated carbon dioxide insufflation in CT colonography in terms of colonic distention and perceived burden .


SUBJECTS AND METHODS ; Two hundred twenty-four participants were randomly allocated to one of four groups : control ( no bowel relaxant and IV saline placebo before CT colonography with manual carbon dioxide insufflation ) , hyoscine butylbromide ( IV hyoscine butylbromide before examination with manual carbon dioxide insufflation ) , automated ( no bowel relaxant before examination with automated carbon dioxide insufflation ) , and combined ( hyoscine butylbromide before examination with automated carbon dioxide insufflation ) .


The degree of colonic distention on a 4-point scale , examination time , and participants ' satisfaction , as measured by their responses to a questionnaire , were assessed .


The mean distention grades of all the colonic segments and both positions were 3.22 in the control group , 3.28 in the hyoscine butylbromide group , 3.77 in the automated group , and 3.74 in the combined group .


Compared with manual carbon dioxide insufflation , automated carbon dioxide insufflation significantly improved the clinical adequacy of colonic distention and shortened examination time .


No statistically significant difference was seen in the clinical adequacy of distention between participants who received hyoscine butylbromide and those who did not , or in examination time .


Overall , the participants ' experiences were not different .


Colonic distention was statistically significantly improved by automated carbon dioxide insufflation , but not by the administration of hyoscine butylbromide .


The participants ' tolerance was similar in each group .


Patients with mixed hyperlipidemia usually are in need of combination therapy to achieve low-density lipoprotein cholesterol ( LDL-C ) and triglyceride ( TG ) target values for reduction of cardiovascular risk .


This study investigated the efficacy and safety of adding a new hypolipidemic agent , coenzyme A ( CoA ) to stable statin therapy in patients with mixed hyperlipidemia .


In this multi-center , 8-week , double-blind study , adults who had received 8 weeks of stable statin therapy and had hypertriglyceridemia ( TG level at 2.3-6 .5 mmol/L ) were randomized to receive CoA 400 U/d or placebo plus stable dosage of statin .


Efficacy was assessed by the changes in the levels and patterns of lipoproteins .


Tolerability was assessed by the incidence and severity of adverse events ( AEs ) .


A total of 304 patients with mixed hyperlipidemia were randomized to receive CoA 400 U/d plus statin or placebo plus statin ( n = 152 , each group ) .


After treatment for 8 weeks , the mean percent change in TG was significantly greater with CoA plus statin compared with placebo plus statin ( -25.9 % vs -4.9 % , respectively ; p = 0.0003 ) .


CoA plus statin was associated with significant reductions in TC ( -9.1 % vs -3.1 % ; p = 0.0033 ) , LDL-C ( -9.9 % vs 0.1 % ; p = 0.003 ) , and non - high-density lipoprotein cholesterol ( -13.5 % vs -5.7 % ; p = 0.0039 ) .


There was no significant difference in the frequency of AEs between groups .


No serious AEs were considered treatment related .


In these adult patients with persistent hypertriglyceridemia , CoA plus statin therapy improved TG and other lipoprotein parameters to a greater extent than statin alone and has no obviously adverse effect .


Current Controlled Trials ClinicalTrials.gov ID NCT01928342 .


The interferon-free regimen of ABT-450 ( a protease inhibitor ) , ritonavir , ombitasvir ( an NS5A inhibitor ) , dasabuvir ( a non-nucleoside polymerase inhibitor ) , and ribavirin has shown efficacy in patients with hepatitis C virus ( HCV ) genotype 1b infection-the most prevalent subgenotype worldwide .


We evaluated whether ribavirin is necessary for ABT-450 , ritonavir , ombitasvir , and dasabuvir to produce high rates of sustained virologic response ( SVR ) in these patients .


We performed a multicenter , open-label , phase 3 trial of 179 patients with HCV genotype 1b infection , without cirrhosis , previously treated with peginterferon and ribavirin .


Patients were assigned randomly ( 1:1 ) to groups given ABT-450 , ritonavir , ombitasvir , and dasabuvir , with ribavirin ( group 1 ) or without ( group 2 ) for 12 weeks .


The primary end point was SVR 12 weeks after treatment ( SVR12 ) .


We assessed the noninferiority of this regimen to the rate of response reported ( 64 % ) for a similar population treated with telaprevir , peginterferon , and ribavirin .


Groups 1 and 2 each had high rates of SVR12 , which were noninferior to the reported rate of response to the combination of telaprevir , peginterferon , and ribavirin ( group 1 : 96.6 % ; 95 % confidence interval , 92.8 % -100 % ; and group 2 : 100 % ; 95 % confidence interval , 95.9 % -100 % ) .


The rate of response in group 2 was noninferior to that of group 1 .


No virologic failure occurred during the study .


Two patients ( 1.1 % ) discontinued the study owing to adverse events , both in group 1 .


The most common adverse events in groups 1 and 2 were fatigue ( 31.9 % vs 15.8 % ) and headache ( 24.2 % vs 23.2 % ) , respectively .


Decreases in hemoglobin level to less than the lower limit of normal were more frequent in group 1 ( 42.0 % vs 5.5 % in group 2 ; P < .001 ) , although only 2 patients had hemoglobin levels less than 10 g/dL .


The interferon-free regimen of ABT-450 , ritonavir , ombitasvir , and dasabuvir , with or without ribavirin , produces a high rate of SVR12 in treatment-experienced patients with HCV genotype 1b infection .


Both regimens are well tolerated , as shown by the low rate of discontinuations and generally mild adverse events .


ClinicalTrials.gov number : NCT01674725 .


This study compared the efficacy of risperidone monotherapy with risperidone plus valproate in bipolar I disorder , manic phase .


Some studies showed the efficacy of risperidone monotherapy in the treatment of bipolar disorder , so we examined this effectiveness in this clinical-trial study .


This 7-week , randomized , single-blind study included 48 bipolar I inpatients manic phase without psychotic features divided in risperidone group ( n = 23 ) and risperidone plus sodium valproate group ( n = 25 ) .


According to clinical symptoms , 3 categories : complete remission , partial remission and no remission were mentioned in weekly follow-up .


Remission rate compared with survival analysis .


The results showed a significant difference in remission rate between risperidone monotherapy and risperidone plus sodium valproate at the 1st , 2nd and the 3rd week ( p = 0.012 , 0.023 , 0.027 respectively ) , It means the remission rate in risperidone plus valproate group was higher in the first three weeks , but at the end of the seventh week , the difference was not statistically significant .


There was no significant difference between the two groups in the development of adverse effects .


Risperidone can be effective and well tolerated in both acute manic episodes of bipolar mood disorders .


Mediastinitis costs hospitals thousands of dollars a year and increases the incidence of patient morbidity and mortality .


No studies have been done to evaluate adenosine triphosphate ( ATP ) counts on disposable and nondisposable electrocardiography ( ECG ) lead wires in pediatric patients .


To compare the cleanliness of disposable and nondisposable ECG lead wires in postoperative pediatric cardiac surgery patients by measuring the quantity of ATP ( in relative luminescence units [ RLUs ] ) .


ATP levels correlate with microbial cell counts and are used by institutions to assess hospital equipment and cleanliness .


A prospective , randomized trial was initiated with approval from the institutional review board .


Verbal consent was obtained from the parents/guardians for each patient .


Trained nurses performed ATP swabs on the right and left upper ECG cables on postoperative days 1 , 2 , and 3 .


This study enrolled 51 patients .


The disposable ECG lead wire ATP count on postoperative day 1 ( median , 157 RLUs ) was significantly lower ( P < .001 ) than the count for nondisposable ATP lead wires ( median , 610 RLUs ) .


On postoperative day 2 , the ATP count for the disposable ECG lead wires ( median , 200 RLUs ) was also lower ( P = .06 ) than the count for the nondisposable ECG lead wires ( median , 453 RLUs ) .


Results of this study support the use of disposable ECG lead wires in postoperative pediatric cardiac surgery patients for at least the first 48 hours as a direct strategy to reduce the ATP counts on ECG lead wires .


Ripasudil hydrochloride hydrate ( K-115 ) , a novel rho kinase inhibitor , provides statistically significant intraocular pressure ( IOP ) - lowering effects and has a tolerable safety profile .


However , no studies have evaluated ripasudil combined with - blockers and prostaglandin analogues .


To evaluate the additive IOP-lowering effects and the safety of ripasudil , 0.4 % , combined with timolol , 0.5 % , or latanoprost , 0.005 % , in patients with primary open-angle glaucoma or ocular hypertension .


We conducted 2 , multicenter , randomized , double-masked , parallel group comparison studies of ripasudil-timolol and ripasudil-latanoprost in 29 and 36 Japanese clinical centers , respectively .


Analyses were performed on an intention-treat-treat basis .


After appropriate run-in periods with timolol or latanoprost , 208 and 205 patients whose IOP levels were 18 mm Hg or higher were enrolled in the ripasudil-timolol and ripasudil-latanoprost groups , respectively .


Enrollment began December 1 , 2011 , and follow-up was completed on September 7 , 2012 , in the ripasudil-timolol study .


Enrollment began December 1 , 2011 , and follow-up was completed on September 27 , 2012 , in the ripasudil-latanoprost study .


Patients were subdivided into 2 groups in each study and were treated with ripasudil or placebo twice daily for 8 weeks .


The IOP reductions in the ripasudil and placebo groups were analyzed with a repeated-measures analysis of variance model at weeks 4 , 6 , and 8 , at trough ( before instillation [ 9 am ] ) and peak ( 2 hours after instillation [ 11 am ] ) levels .


In the ripasudil-timolol study , the mean IOP reductions from baseline in the ripasudil and placebo groups were -2.4 and -1.5 mm Hg at 9 am for a difference of 0.9 mm Hg ( 95 % CI , 0.4-1 .3 mm Hg ; P < .001 ) and -2.9 and -1.3 mm Hg at 11 am for a difference of 1.6 mm Hg ( 95 % CI , 1.1-2 .1 mm Hg ; P < .001 ) , respectively .


In the ripasudil-latanoprost study , those IOP reductions were -2.2 and -1.8 mm Hg at 9 am for a difference of 0.4 mm Hg ( 95 % CI , -0.0 to 0.9 mm Hg ; P = .06 ) and -3.2 and -1.8 mm Hg at 11 am for a difference of 1.4 mm Hg ( 95 % CI , 0.9-1 .9 mm Hg ; P < .001 ) , respectively .


The most frequently reported adverse event was conjunctival hyperemia , which was mild and in most cases resolved without treatment before the next instillation .


These clinical trials found additive IOP-lowering effects of ripasudil from placebo at trough and peak levels in combination with timolol and at peak level in combination with latanoprost .


However , a definitive difference in the addition of placebo to latanoprost was not identified in the trough level .


clinicaltrials.jp Identifiers : JAPIC111700 and JAPIC111701 .


Two single-dose studies were conducted in Japan and Europe to compare the pharmacokinetic ( PK ) and pharmacodynamic ( PD ) profiles of new insulin glargine 300U/ml ( Gla-300 ) and insulin glargine 100U/ml ( Gla-100 ) in people with type 1 diabetes mellitus .


In two double-blind , randomized , crossover studies , 18 Japanese participants ( aged 20-65years ) and 24 European participants ( aged 18-65years ) with glycated haemoglobin levels 9.0 % ( 75mmol/mol ) received single subcutaneous doses of Gla-300 , 0.4 , 0.6 and 0.9 U/kg ( 0.9 U/kg in the European study only ) , and Gla-100 , 0.4 U/kg .


A 36-h euglycaemic clamp procedure was performed after each dosing .


The serum insulin glargine concentration ( INS ) and glucose infusion rate ( GIR ) developed more gradually into more constant and prolonged profiles with Gla-300 than with Gla-100 .


In support of this , the times to 50 % of glargine exposure and insulin activity were longer for all Gla-300 doses than for Gla-100 during the 36-h clamp period , indicating a more evenly distributed exposure and metabolic effect beyond 24h .


Exposure to insulin glargine and glucose utilization were lower with the 0.4 and 0.6 U/ml Gla-300 doses in both studies compared with the 0.4 U/ml Gla-100 dose .


Glucose-lowering activity was detected for up to 36h with all doses of Gla-300 .


Single-dose injections of Gla-300 present more constant and prolonged PK and PD profiles compared with Gla-100 , maintaining blood glucose control for up to 36h in euglycaemic clamp settings in Japanese and European participants with type 1 diabetes .


To investigate whether methotrexate ( MTX ) use , as compared to other therapies , and erythrocyte methotrexate polyglutamate ( MTXGlu ) concentrations are associated with changes in glycosylated hemoglobin ( HbA1c ) levels in rheumatoid arthritis ( RA ) patients .


The derivation cohort consisted of patients selected from the Treatment in the Rotterdam Early Arthritis Cohort who fulfilled the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for RA .


Patients were randomized to 6 treatment arms : triple disease-modifying antirheumatic drug ( DMARD ) therapy ( consisting of MTX , sulfasalazine , and hydroxychloroquine [ HCQ ] ) + intramuscular ( IM ) glucocorticoids , triple DMARD therapy + oral glucocorticoids , MTX + oral glucocorticoid therapy , MTX therapy , oral glucocorticoid therapy , and HCQ therapy .


HbA1c levels were determined at baseline and at 3 months .


Concentrations of erythrocyte MTXGlu1-5 were measured after 3 months of treatment .


Within treatment arms , changes in the level of HbA1c were compared by paired t-test .


Associations of MTXGlu concentrations with changes in the level of HbA1c were tested using multiple linear regression analysis , adjusted for age , sex , body mass index , and comedication .


Significant associations were validated using data on RA patients taking MTX who were enrolled in the Methotrexate in Rotterdam cohort .


In the derivation cohort , the mean change in HbA1c level after 3 months of treatment was -1.9 mmoles/mole ( -0.18 % ) ( P = 0.001 ) .


Levels of HbA1c decreased in 4 of the individual treatment groups , as follows : for the triple DMARD therapy + IM glucocorticoids treatment arm , -5.5 mmoles/mole ( -0.50 % ) ( P < 0.001 ) , for the triple DMARD therapy + oral glucocorticoids treatment arm , -3.7 mmoles/mole ( -0.34 % ) ( P < 0.001 ) , for the MTX treatment arm , -0.8 mmoles/mole ( -0.08 % ) ( P = 0.018 ) , and for the HCQ treatment arm , -2.0 mmoles/mole ( -0.19 % ) ( P = 0.175 ) .


Increased levels of MTXGlu2 ( = -0.20 , P = 0.005 ) , MTXGlu3 ( = -0.31 , P < 0.001 ) , MTXGlu4 ( = -0.33 , P < 0.001 ) after treatment , MTXGlu5 ( = -0.39 , P < 0.001 ) , and total MTXGlu ( = -0.29 , P < 0.001 ) were associated with decreased levels of HBA1c .


In the validation cohort , levels of HbA1c were decreased by 2.6 mmoles/mole ( 0.23 % ) ( P < 0.001 ) after treatment , and MTXGlu3 was associated with decreased levels of HbA1c ( = -0.26 , P = 0.018 ) .


MTX use and higher concentrations of erythrocyte MTXGlu are associated with decreased levels of HbA1c in RA patients .


Triple DMARD therapy and HCQ treatment resulted in reduced HbA1c levels , and glucocorticoid treatment resulted in increased levels of HbA1c .


To evaluate the accuracy of sonographic classification of chorionicity in a large cohort of twins and investigate which factors may be associated with sonographic accuracy .


We conducted a secondary analysis of a randomized trial of preterm birth prevention in twins .


Sonographic classification of chorionicity was compared with pathologic examination of the placenta .


Maternal ( age , body mass index , diabetes , and hypertension ) , obstetric ( prior cesarean delivery , gestational age at the first sonographic examination , and antepartum bleeding ) , and sonographic ( oligohydramnios , polyhydramnios , and twin-twin transfusion syndrome ) factors were assessed for their possible association with accuracy .


A total of 545 twin sets in which chorionicity was classified by sonography before 20 weeks ' gestation were included ; 455 were dichorionic and 90 were monochorionic based on pathologic examination .


Sonography misclassified 35 of 545 twin pregnancies ( 6.4 % ) : 18 of 455 dichorionic twins ( 4.0 % ) and 17 of 90 monochorionic twins ( 19.0 % ) .


The sensitivity and specificity of sonographic diagnosis of monochorionicity were 81.1 % and 96.0 % , respectively .


In a multivariable analysis , pregnancies with initial sonographic examinations before 14 weeks ' gestation were less likely to have misclassified chorionicity than those with sonographic examinations at 15 to 20 weeks ( odds ratio [ OR ] , 0.47 ; 95 % confidence interval [ CI ] , 0.23-0 .96 ) .


For each week increase in gestational age , the odds of misclassification rose by 10 % ( OR , 1.10 ; 95 % CI , 1.01-1 .2 ) .


In the multivariable analysis , maternal age , body mass index , parity , and prior cesarean delivery were not associated with sonographic accuracy .


Sonography before 20 weeks incorrectly classified chorionicity in 6.4 % of twin gestations .


Those with first sonographic examinations performed at earlier gestational ages had improved chorionicity diagnosis .


The purpose of this study was to investigate and validate adaptation of a cardiovascular CT angiography contrast injection protocol for lower tube potential .


Eighty-three patients evaluated for thoracic aortic disease with a 256-MDCT scanner were imaged at 120 kV ( group 1 ) or 100 kV ( group 2 ) with the same contrast protocol ( 90 mL iopromide 370 mg I/mL at 3.5 mL/s ) .


A pharmacokinetic model was validated and used to simulate aortic attenuation in group 2 patients with 20 % , 33 % , and 44 % reduction in contrast volume .


A 44 % volume reduction was applied to 50 additional patients who underwent imaging at 100 kV ( group 3 ) .


Patient characteristics , scanning and radiation parameters , and objective and subjective image indexes were compared among groups .


Group 2 patients had higher mean aortic blood attenuation ( 39961 HU ) than group 1 patients ( 28148 HU ) ( p < 0.001 ) but similar image noise .


Group 3 and group 1 patients had similar mean aortic attenuation and noise .


Subjective assessment of image quality indicated that group 3 and group 1 had comparable percentages of images with good or excellent diagnostic confidence scores ( reader 1 , 98 % vs 96 % ; reader 2 , 96 % vs 96 % ) .


Lower tube potential ( 100 kV ) for cardiothoracic CT could be accompanied by a 44 % reduction in contrast volume with satisfactory aortic blood-pool attenuation in most patients .


More personalized adaptation of the contrast protocol that takes into account patient characteristics and tube potential is necessary to ensure sufficient contrast enhancement for all patients .


A low response to controlled ovarian hyperstimulation implies a reduced number of embryos and impaired pregnancy rate .


Follicular priming with steroids before controlled ovarian hyperstimulation has been suggested to improve the subsequent ovarian response .


The purpose of this study was to determine the best follicular priming protocol in low responders and to investigate the intrafollicular mechanisms triggered by steroid hormone priming .


This was a single-center , randomized , parallel , open-label , controlled trial , in two phases .


The setting was a university-based in vitro fertilization unit .


Potential low responders ( n = 99 ) underwent a first intracytoplasmic sperm injection cycle .


Confirmed low responders ( n = 66 ) were randomized to different priming protocols before a new intracytoplasmic sperm injection .


Randomized patients underwent one of the following priming strategies : transdermal testosterone ( 20 g/kg/d ) , transdermal estradiol ( 200 g/d ) , or combined estrogens and oral contraceptive pills ( 30 g of ethinyl estradiol plus 150 g of desogestrel administered during the luteal phase of two consecutive cycles ) and 4 mg/d of estradiol valerate during the follicular phase between them .


Metaphase II ( MII ) oocytes were retrieved .


Gene expression levels in the granulosa cells of steroidogenesis enzymes and FSH , LH , and androgen receptors were measured .


The number of retrieved MII oocytes did not differ between the interventional groups ( testosterone , 2.2 2.0 ; estrogen , 2.7 1.7 ; and combined estrogens and oral contraceptive pills , 2.0 1.3 ; not significant ) .


Compared with those in nonprimed cycles , estradiol pretreatment yielded more MII oocytes ( primed , 2.7 1.7 ; nonprimed , 1.6 1.2 ; P = .029 ) although the clinical pregnancy rate was higher in patients treated with testosterone ( P = .003 ) .


Testosterone pretreatment increased androgen receptor expression ( P = .028 ) compared with that for the previous cycle without priming .


The results of the present trial do not support the superiority of one priming strategy over the others .


Tumor necrosis factor ( TNF ) and , possibly , lymphotoxin alpha ( LT ) signaling contribute to inflammation and rheumatoid arthritis ( RA ) pathogenesis .


Pateclizumab ( anti-lymphotoxin - alpha ; MLTA3698A ) is a humanized monoclonal antibody that blocks and depletes anti-LT .


This phase 2 , randomized , head-to-head , active - and placebo-controlled trial examined the safety and efficacy of pateclizumab compared to adalimumab in RA patients with an inadequate response to disease-modifying antirheumatic drugs ( DMARD-IR ) .


Patients ( n = 214 ) with active RA ( 6 swollen and tender joints , C-reactive protein 10 mg/L ) on oral DMARDs were randomized ( 2:2:1 ) to receive pateclizumab 360 mg , adalimumab 40 mg , or placebo subcutaneously every 2 weeks .


The primary endpoint , 4-variable , 28-joint disease activity score erythrocyte sedimentation rate ( DAS28 ( 4 ) - ESR ) response , was evaluated at 12 weeks using an analysis of covariance ( ANCOVA ) model with adjustments for concomitant DMARD use and geographic region .


Secondary efficacy endpoints included American College of Rheumatology ( ACR ) 20 , ACR50 , and ACR70 responses at Day 85 .


Pharmacokinetics , pharmacodynamics , and immunogenicity of pateclizumab were assessed .


Pateclizumab reduced the DAS28 ( 4 ) - ESR response ( -1.89 ) at 12 weeks , however , this did not reach statistical significance compared to placebo ( -1.54 ) , while adalimumab ( -2.52 ) differed significantly from both placebo and pateclizumab .


Pateclizumab 12-week ACR20 , ACR50 and ACR70 response rates ( 64 % , 33 % , and 14 % ) suggested clinical activity but were not statistically significant compared to placebo rates ( 46 % , 24 % , and 8 % , respectively ) .


CXCL13 serum levels decreased significantly following pateclizumab and adalimumab administration , demonstrating pharmacological target engagement by both drugs .


Overall , adverse events ( AEs ) were comparable among all cohorts .


Infections were the most common AE , occurring with comparable frequency in all groups .


Serious AEs occurred in 0 % of pateclizumab , 5.9 % of adalimumab , and 2.3 % of placebo patients , with serious infection in 2.3 % of adalimumab patients and none in pateclizumab and placebo patients .


Pateclizumab had a good safety profile in patients inadequately responsive to DMARDs , but no statistically significant improvement in RA signs and symptoms after 12 weeks of treatment .


Adalimumab demonstrated efficacy and safety comparable to published results in this head-to-head comparison in DMARD-IR RA patients .


ClinicalTrials.gov NCT01225393 , Registered 18 October 2010 .


To observe the effect and safety of plastering Chinese Compound Shenhuang Ointment ( CSO ) at Shenque ( RN8 ) in promoting the rehabilitation of postoperative gastrointestinal dysfunction patients of qi stagnation blood stasis syndrome ( QSBSS ) .


A prospective , multi-centered , randomized , double-blinded , controlled trial was conducted in 220 postoperative gastrointestinal dysfunction patients of QSBSS .


They were randomly assigned to two groups , the CSO group ( 110 cases ) and the placebo group ( 110 cases ) .


CSO was plastered at Shenque ( RN8 ) for 5 days after operation .


The time of exhaustion , defecation , the recovery of intestinal peristalsis , integrals of TCM syndrome , and serum levels of motilin ( MOT ) and somatostatin ( SS ) were observed .


Compared with the placebo group , the condition of exhaustion and defecation , the recovery of intestinal peristalsis on the 3rd day after operation was all improved ( P < 0.05 ) .


The integrals of TCM syndrome at day 2 , 3 , and 4 were more significantly lowered in the CSO group than in the placebo group ( P < 0.01 , P < 0.05 ) .


The total effective rate of TCM syndrome was 95.3 % in the CSO group , better than that in the placebo group ( 91.8 % , P < 0.05 ) .


Compared with the placebo group , the serum MOT level increased and the serum SS level decreased at day 5 after operation in the CSO group ( P < 0.05 ) .


The plastering of CSO at Shenque ( RN8 ) could advance the time of exhaustion and defecation , and improve patients ' clinical symptoms .


And patients could tolerate well .


To investigate the feasibility of bilateral thoracic paravertebral block for postoperative analgesia in patients after off-pump coronary artery bypass grafting ( OPCABG ) .


Upon the approval of institutional Ethics Committee and informed consent , forty patients ASAII or III aged 52-77 yr with BMI ( body mass index ) < 30 kg/m ( 2 ) , undergoing OPCABG , were randomly divided by random numbers into two groups ( n = 20 each ) : thoracic paravertebral block for postoperative analgesia group ( group P ) and patient-controlled intravenous analgesia ( PCIA ) group ( group I ) .


Bilateral thoracic paravertebral block and insertion epidural catheter were performed at T3 , 4 interspace prior to induction of anesthesia in group P.


At the end of the operation , an infusion of 0.375 % ropivacaine was injected at the rate of 5 ml/h up to 48 h.Group I received PCIA with morphine .


Dermatomes of hypoalgesia in group P were recorded .


The following indexes were recorded at 12 , 24 , 36 and 48 hours after postoperative analgesia beginning : VAS scores of rest pain , cough pain and sedation score .


To evaluate stability of circulation .


Cycle time , complications and side effects after operation were recorded .


Dermatomes of hypoalgesia was 5.1 1.0 segments in group P. VAS scores of rest pain ( 2.4 0.4 , 2.6 0.5 , 2.4 0.4 , 2.2 0.3 vs 3.7 0.7 , 3.6 0.8 , 3.4 0.6 , 3.1 0.6 , all P < 0.01 ) , cough pain ( 3.7 0.8 , 3.9 1.0 , 3.8 1.1 , 3.8 0.9 vs 4.4 1.1 , 4.9 1.3 , 4.8 1.3 , 4.3 1.2 , P < 0.05 , < 0.01 ) and sedation scores ( 2.2 0.4 , 2.0 0.4 , 1.9 0.3 , 1.8 0.3 , 2.6 0.5 , 2.5 0.4 , 2.4 0.5 , 2.2 0.4 , P < 0.05 ) in group P were significantly lower than in group I at the four points .


The incidences of sinus tachycardia ( 5 % vs 25 % ) and hypertension ( 0 vs 30 % ) in group P were significantly reduced than in group I ( P < 0.05 ) , and there were no significant difference in the incidences of sinus brachycardia ( 30 % vs 15 % ) and hypotension ( 20 % vs 10 % ) ( P > 0.05 ) .


Compared with group I , extubation time ( 5.5 1.4 vs 7.1 1.7 ) and residence time in ICU ( 17.3 4.2 vs 21.4 5.8 ) were shortened significantly in group P ( P < 0.05 ) , and there were no significant difference in length of stay after operation ( 10.5 2.6 vs 11.7 2.8 , P > 0.05 ) .


The incidence rate of nausea in group P was significantly lower than in group I ( 5 % vs 25 % , P < 0.05 ) , and there were no significant difference in the other complications and side effects after operation ( P > 0.05 ) .


Bilateral thoracic paravertebral block for postoperative analgesia could be used safely and efficiently and accelerate the cycle time in patients after OPCABG .


Bone loss and subclinical diabeteslike are developed during long-term spaceflight .


Recently , it was demonstrated that bone was able to regulate energy metabolism and testosterone synthesis via osteocalcin .


The aim of this study was to determine whether serum osteocalcin level is associated with glycolipid metabolism or testosterone under the influence of microgravity with or without resistive vibration exercise ( RVE ) .


A total of 14 healthy adult male volunteers ( 25-40years ) were randomly assigned to two groups ( n = 7 each ) : control ( CON ) group and RVE group .


Radioimmunoassay kits and ELISA kits were used for measurement of serum indices .


During 60-day bed rest , serum osteocalcin of both groups increased at day 4 during bed rest .


Serum OPG started decreasing and reached its lowest value at day 30 during bed rest .


In control group , serum insulin increased at day 4 during bed rest .


IGF-I did not change significantly during the entire period of bed rest .


The serum glucose decline 10 % and 14 % in CON and RVE groups at day 4 during bed rest .


Relatively , the same results as glucose were found in serum HDL and LDL for both groups .


Leptin rose and became highest at day 60 during bed rest in both groups .


The level of serum testosterone was declined in control group at day 4 during bed rest .


Cortisol kept stable in both group during bed rest .


By spearman correlation analysis , serum osteocalcin was significantly associated with serum insulin ( P < 005 ) , LDL ( P < 001 ) and Leptin ( P < 001 ) .


Our findings suggested that the mutual regulation may exist between skeletal and energy metabolism under simulated microgravity .


Segmental muscle vibration ( SMV ) improves motor performances in neurological conditions , including stroke .


To determine if SMV modifies upper limb muscular activity in chronic stroke patients performing a reaching movement .


We randomized 22 chronic stroke patients to an experimental group ( EG ; n = 12 ) , receiving 10 sessions of exercise + 120 Hz SMV over the biceps brachii ( BB ) and the flexor carpi ulnaris ( FCU ) muscles , or to a control group ( CG ; n = 10 ) receiving exercise only .


All subjects performed a reaching movement with the affected side before and 4 weeks after therapy ended .


We recorded surface EMG activity of the anterior deltoid ( AD ) , posterior deltoid ( PD ) , BB , triceps brachii ( TB ) , FCU and extensor carpi radialis ( ECR ) muscles .


We calculated muscular onset times , modulation ratio , co-contractions and degree of contraction .


After SMV , onset times of the PD ( p = 0.03 ) , BB ( p = 0.02 ) and ECR ( p = 0.04 ) in the EG were less anticipated than at baseline ; the modulation ratio increased in AD ( p = 0.003 ) and BB ( p = 0.01 ) ; co-contractions decreased in the pairs BB/TB ( p = 0.007 ) , PD/BB ( p = 0.004 ) and AD/BB ( p = 0.01 ) ; and the degree of contraction decreased in BB ( p = 0.01 ) .


The modulation of muscular function induced by SMV may aid to explain its action on smoothness and coordination of movements .


The objective of this study is to assess the efficacy of an intervention designed to promote resilience in young children living with their HIV-positive mothers .


HIV-positive women attending clinics in Tshwane , South Africa , and their children , aged 6-10 years , were randomized to the intervention ( I ) or standard care ( S ) .


The intervention consisted of 24 weekly group sessions led by community care workers .


Mothers and children were in separate groups for 14 sessions , followed by 10 interactive sessions .


The primary focus was on parent-child communication and parenting .


Assessments were completed by mothers and children at baseline and 6 , 12 and 18 months .


Repeated mixed linear analyses were used to assess change over time .


Of 390 mother-child pairs , 84.6 % ( I : 161 and S : 169 ) completed at least two interviews and were included in the analyses .


Children 's mean age was 8.4 years and 42 % of mothers had been ill in the prior 3 months .


Attendance in groups was variable : only 45.7 % attended more than 16 sessions .


Intervention mothers reported significant improvements in children 's externalizing behaviours ( = -2.8 , P = 0.002 ) , communication ( = 4.3 , P = 0.025 ) and daily living skills ( = 5.9 , P = 0.024 ) , although improvement in internalizing behaviours and socialization was not significant ( P = 0.061 and 0.052 , respectively ) .


Intervention children reported a temporary increase in anxiety but did not report differences in depression or emotional intelligence .


This is the first study demonstrating benefits of an intervention designed to promote resilience among young children of HIV-positive mothers .


The intervention was specifically designed for an African context and has the potential to benefit large numbers of children , if it can be widely implemented .


Data about the vaccination status of participants are required in epidemiological cohort studies whenever infection or immunity is considered as potential exposure or outcome .


Within Pretest 2 of the German National Cohort ( GNC ) we therefore investigated the acceptance and feasibility of extracting vaccination status from vaccination certificates provided by the participants of the study .


This study was conducted in three study centers ( Bremen , n = 73 ; Hamburg , n = 200 ; Hannover , n = 193 ) .


In order to test if an additional reminder would prevent participants from forgetting their vaccination certificates at home persons willing to participate in Pretest 2 were randomly assigned to one of three invitation groups ( IG ) .


About one third of the participants received either no further reminder ( IG1 ) , a reminder card together with the appointment letter ( IG2 ) or a separate reminder card 4 days before the appointment ( IG3 ) .


At the study center , vaccination data were scanned or copied and entered into a database using a unique identification number .


Participants were also asked to fill in a short questionnaire to assess the completeness of the provided vaccination data .


Additionally , in one of the three participating study centers , general practitioners ( GP ) were asked to provide vaccination data from their records following respective participants ' consent .


Finally , we compared the influenza data from the vaccination certificates with the influenza data obtained from participants in Pretest 2 by use of a self-administered questionnaire ( ID-Screen ) .


Due to different starting dates of the study the intended reminder procedure was implemented only in Hamburg and Hannover .


In Hamburg , significantly more vaccination certificates were submitted by the group which received the reminder card separately 4 days before the examination ( IG3 ) compared to IG1 and IG2 ( p = 0.04 ) .


In Hannover , in contrast , most vaccination certificates were brought by those who received the reminder card together with the appointment letter .


Overall , the use of a reminder card had a positive but not significant effect as 89 % ( 185/209 ) of participants who received the reminder card submitted vaccination data versus 81 % ( 84/104 ) of participants who did not receive any reminder card ( p = 0.06 ) .


Of all Pretest 2 participants in Hannover , 62 % ( 120/193 ) gave written consent for data collection by the GPs .


In total , 114 practices were contacted of which 49 ( 43 % ) sent vaccination data .


All in all , 360 vaccination certificates with 5065 documented vaccinations were entered into a database , of which 4830 ( 95 % ) were valid for analysis covering a period from 1946 to 2012 .


The comparison of influenza vaccination data from vaccination certificates to the remembered data from a self-completed questionnaire showed an agreement of data in 46 % ( 84/184 ) of cases ( Kappa = 0.48 ) .


Influenza vaccinations were underreported in 4 % ( 7/170 ) of self-completed questionnaires .


The reliable documentation of vaccinations within the context of the GNC proved to be feasible and thus recommendable at a large scale within the GNC as participants showed high willingness and compliance in providing available vaccination documents .


An additional validation by means of documents provided by physicians seems to be possible for more than a quarter of participants .


In order to maximize the likelyhood of participants ' of bringing their vaccination certificates it would be sufficient to send a reminder card together with the appointment letter .


Successful recruitment and retention of participants into research studies is critical for optimising internal and external validity .


Research into diet and lifestyle of young women is important due to the physiological transitions experienced at this life stage .


This paper aims to evaluate data related to recruitment and retention across three research studies with young women , and present practical advice related to recruiting and retaining young women in order to optimise study quality within nutrition research .


Recruitment and retention strategies used in three nutrition studies that targeted young women ( 18 to 35 years ) were critiqued .


A randomised controlled trial ( RCT ) , a crossover validation study and a cross-sectional survey were conducted at the University of Newcastle , Australia between 2010 and 2013Successful recruitment was defined as maximum recruitment relative to time .


Retention was assessed as maximum participants remaining enrolled at study completion .


Recruitment approaches included notice boards , web and social network sites ( Facebook and Twitter ) , with social media most successful in recruitment .


The online survey had the highest recruitment in the shortest time-frame ( 751 participants in one month ) .


Email , phone and text message were used in study one ( RCT ) and study two ( crossover validation ) and assisted in low attrition rates , with 93 % and 75.7 % completing the RCT and crossover validation study respectively .


Of those who did not complete the RCT , reported reasons were : being too busy ; and having an unrelated illness .


Recruiting young women into nutrition research is challenging .


Use of social media enhances recruitment , while Email , phone and text message contact improves retention within interventions .


Further research comparing strategies to optimise recruitment and retention in young women , including flexible testing times , reminders and incentives is warranted .


Approximately 85 % of vaginal deliveries are accompanied by perineal trauma .


The objective of this trial is to compare the incidence and degree of perineal trauma after primary delivery of the anterior compared with the posterior shoulder during vaginal birth .


The hypothesis is that primary delivery of the posterior shoulder reduces the rate and degree of perineal trauma .


This is a single-centre , randomized controlled trial , with computer-generated randomization in a 1:1 allocation ratio .


Women planning their first vaginal delivery ( n = 650 ) are randomized to primary delivery of either the anterior or posterior shoulder .


The primary outcome is any perineal trauma .


Additional outcomes are the perineal injury subtypes , postpartum bleeding , umbilical artery pH , Apgar score at 5minutes and any neonatal birth trauma .


Perineal trauma is assessed by a midwife or doctor blinded to the method of shoulder delivery .


All midwives are trained in the two methods of shoulder delivery and in the grading of perineal tears .


The trial is being undertaken at a Danish community hospital with 1,600 yearly deliveries .


Data will be analyzed according to the intention-to-treat principle .


Recruitment started in January 2013 and the trial is planned to proceed for 24months .


Most delivery assistance techniques are based on tradition and heritage and lack objective evidence .


This trial provides an example of how vaginal delivery techniques can be evaluated in a randomized controlled trial .


The results of this trial will clarify the role that delivery of the shoulders has on perineal trauma and thereby provide knowledge to recommendations on birthing technique .


ClinicalTrials.gov : NCT01937546 .


We investigated the effects of intracoronary transplantation of CD34 ( + ) cells on myocardial perfusion in patients with nonischemic dilated cardiomyopathy ( DCM ) .


We enrolled 21 patients with DCM ( left ventricular ejection fraction [ LVEF ] < 40 % , New York Heart Association functional class III ) who underwent peripheral stem cell mobilization with granulocyte-colony stimulating factor ( G-CSF ) .


CD34 ( + ) cells were collected by means of apheresis .


Patients underwent myocardial perfusion imaging , and CD34 ( + ) cells were injected in the coronary artery supplying viable segments with reduced myocardial perfusion and regional dysfunction .


Myocardial perfusion imaging was repeated 6 months later .


Clinical response to stem cell therapy was predefined as a change in LVEF > 5 % .


The majority of patients were men ( 81 % ) with an overall mean age 53 9 years , LVEF 25 5 % , and 6-minute walking distance 354 71 m. Myocardial perfusion defects at rest were observed in 86 % of patients and were more common in the left anterior descending territory ( 50 % ) .


At 6 months ' follow-up , there was a significant improvement in rest myocardial perfusion scores ( 6.3 5.8 vs 3.1 4.3 ; P < .001 ) , LVEF ( 25 7 % vs 29 8 % ; P = .005 ) , and 6-minute walking distance ( 354 71 m vs 404 91 m ; P < .001 ) .


Responders to stem cell therapy had lower summed rest perfusion score at both baseline ( 3.2 3.0 vs 9.1 6.3 ; P = .015 ) and follow-up ( 1.0 1.5 vs 5.0 5.1 ; P = .028 ) .


CD34 ( + ) cell transplantation may lead to improved myocardial perfusion in patients with nonischemic DCM .


Patients with less severe myocardial perfusion defects at baseline may have an increased likelihood to respond to intracoronary CD34 ( + ) cell transplantation .


Appropriate guideline criteria for use of implantable cardioverter-defibrillators ( ICDs ) do not take into account potential recovery of left ventricular ejection fraction ( LVEF ) in patients treated with CRT-defibrillator .


Patients randomized to CRT-defibrillator from the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy ( MADIT-CRT ) trial who survived and had paired echocardiograms at enrollment and at 12 months ( n = 752 ) were included .


Patients were evaluated by LVEF recovery in 3 groups ( LVEF 35 % [ reference ] , 36 % -50 % , and > 50 % ) on outcomes of ventricular tachyarrhythmias ( VTAs ) , VTA 200 bpm , ICD shock , heart failure or death , and inappropriate ICD therapy by multivariable Cox models .


A total of 7.3 % achieved LVEF normalization ( > 50 % ) .


The average follow-up was 2.20.8 years .


The risk of VTA was reduced in patients with LVEF > 50 % ( hazard ratio [ HR ] , 0.24 ; 95 % confidence interval [ CI ] , 0.07-0 .82 ; P = 0.023 ) and LVEF of 36 % to 50 % ( HR , 0.44 ; 95 % CI , 0.28-0 .68 ; P < 0.001 ) .


Among patients with LVEF > 50 % , only 1 patient had VTA 200 bpm ( HR , 0.16 ; 95 % CI , 0.02-1 .51 ) , none were shocked by the ICD , and 2 died of nonarrhythmic causes .


The risk of HF or death was reduced with improvements in LVEF ( LVEF > 50 % : HR , 0.29 ; 95 % CI , 0.09-0 .97 ; P = 0.045 ; and LVEF of 36 % -50 % : HR , 0.44 ; 95 % CI , 0.28-0 .69 ; P < 0.001 ) .


For inappropriate ICD therapy , no additional risk reduction for LVEF > 50 % was seen compared with an LVEF of 36 % to 50 % .


A total of 6 factors were associated with LVEF normalization , and patients with all factors present ( n = 42 ) did not experience VTAs ( positive predictive value , 100 % ) .


Patients who achieve LVEF normalization ( > 50 % ) have very low absolute and relative risk of VTAs and a favorable clinical course within 2.2 years of follow-up .


Risk of inappropriate ICD therapy is still present , and these patients could be considered for downgrade from CRT-defibrillator to CRT-pacemaker at the time of battery depletion if no VTAs have occurred .


http://www.clinicaltrials.gov .


Unique identifier : NCT00180271 .


Animal models suggest that neuroactive steroids contribute to alcohol 's acute effects .


We previously reported that a common nonsynonymous polymorphism , AKR1C3 2 in the gene encoding the enzyme 3-HSD2 / 17-HSD5 , and a synonymous single nucleotide polymorphism ( SNP ) , rs248793 , in SRD5A1 , which encodes 5-reductase , were associated with alcohol dependence ( AD ) .


The aim of the study was to investigate whether these polymorphisms moderate subjective effects of alcohol in humans and whether AKR1C3 2 affects neuroactive steroid synthesis .


Sixty-five Caucasian men ( 34 lighter and 31 heavier drinkers ; mean age 26.2 years ) participated in a double-blind laboratory study where they consumed drinks containing no ethanol or 0.8 g/kg of ethanol .


Breath alcohol , heart rate ( HR ) , and self-reported alcohol effects were measured at 40-min intervals , and genotype was examined as a moderator of alcohol 's effects .


Levels of the neuroactive steroid 5-androstane-3 ,17 - diol and its precursors , 3,5-androsterone and dihydrotestosterone , were measured at study entry using GC/MS .


Initially , carriers of the AD-protective AKR1C3 2G allele had higher levels of 5-androstane-3 ,17 - diol relative to the precursor 3,5-androsterone than C allele homozygotes .


AKR1C3 2G allele carriers exhibited greater increases in heart rate and stimulant and sedative effects of alcohol than C allele homozygotes .


The genotype effects on sedation were observed only in heavier drinkers .


The only effect of the SRD5A1 SNP was to moderate HR .


There were no interactive effects of the two SNPs .


The observed effects of variation in a gene encoding a neuroactive steroid biosynthetic enzyme on the rate of 17-reduction of androsterone relative to androstanediol and on alcohol 's sedative effects may help to explain the association of AKR1C3 2 with AD .


Hyperhomocysteinemia is associated with arterial stiffness , but underlying pathophysiological mechanisms explaining this association are to be revealed .


This study was aimed to explore two potential pathways concerning the one-carbon metabolism .


A potential causal effect of homocysteine was explored using a genetic risk score reflecting an individual 's risk of having a long-term elevated plasma homocysteine level and also associations with B-vitamin levels were investigated .


Baseline cross-sectional data of the B-PROOF study were used .


In the cardiovascular subgroup ( n = 567 , 56 % male , age 72.65.6 yrs ) pulse wave velocity ( PWV ) was determined using applanation tonometry .


Plasma concentrations of vitamin B12 , folate , methylmalonic acid ( MMA ) and holo transcobalamin ( holoTC ) were assessed and the genetic risk score was based on 13 SNPs being associated with elevated plasma homocysteine .


Associations were examined using multivariable linear regression analysis .


B-vitamin levels were not associated with PWV .


The genetic risk score was also not associated with PWV .


However , the homocysteine-gene interaction was significant ( p < 0.001 ) in the association of the genetic risk score and PWV .


Participants with the lowest genetic risk of having long-term elevated homocysteine levels , but with higher measured homocysteine levels , had the highest PWV levels .


Homocysteine is unlikely to be causally related to arterial stiffness , because there was no association with genetic variants causing hyperhomocysteinemia , whereas non-genetically determined hyperhomocysteinemia was associated with arterial stiffness .


Moreover , the association between homocysteine and arterial stiffness was not mediated by B-vitamins .


Possibly , high plasma homocysteine levels reflect an unidentified factor , that causes increased arterial stiffness .


Vorinostat is a histone deacetylase inhibitor that changes gene expression and protein activity .


On the basis of the clinical benefit reported in patients with malignant pleural mesothelioma treated in a phase 1 study of vorinostat , we designed this phase 3 trial to investigate whether vorinostat given as a second-line or third-line therapy improved patients ' overall survival .


This double-blind , randomised , placebo-controlled trial was done in 90 international centres .


Patients with measurable advanced malignant pleural mesothelioma and disease progression after one or two previous systemic regimens were eligible .


After stratification for Karnofsky performance status , histology , and number of previous chemotherapy regimens , patients were randomly assigned ( 1:1 ) by use of an interactive voice response system with a block size of four to either treatment with vorinostat or placebo .


Patients received oral vorinostat 300 mg ( or matching placebo ) twice daily on days 1 , 2 , 3 , 8 , 9 , 10 , 15 , 16 , and 17 of a 21-day cycle .


The primary endpoints were overall survival and safety and tolerability of vorinostat .


The primary efficacy comparison was done in the intention-to-treat population , and safety and tolerability was assessed in the treated population .


This trial is registered with ClinicalTrials.gov , number NCT00128102 .


From July 12 , 2005 , to Feb 14 , 2011 , 661 patients were enrolled and randomly assigned to receive either vorinostat ( n = 329 ) or placebo ( n = 332 ) and included in the intention-to-treat analysis .


Median overall survival for vorinostat was 307 weeks ( 95 % CI 267-361 ) versus 271 weeks ( 231-319 ) for placebo ( hazard ratio 098 , 95 % CI 083-117 , p = 086 ) .


The most common grade 3 or worse adverse events for patients treated with vorinostat were fatigue or malaise ( 51 [ 16 % ] patients in the vorinostat group vs 25 [ 8 % ] in the placebo group ] ) and dyspnoea ( 35 [ 11 % ] vs 45 [ 14 % ] ) .


In this randomised trial , vorinostat given as a second-line or third-line therapy did not improve overall survival and can not be recommended as a therapy for patients with advanced malignant pleural mesothelioma .


Merck & Co. .


Delirium ( or acute confusion ) is a serious illness common in older people , in which a person 's thinking and perceptions may be affected .


Reducing delirium is important because of the considerable distress it causes , and the poor outcomes associated with it , such as increased admissions to hospital , falls , mortality and costs to the National Health Service ( NHS ) .


Preventing delirium is possible using multicomponent interventions ; successful interventions in hospitals have reduced it by one-third .


However , there is little research to guide practice in care homes , where it is common because of the clustering of known risk factors ( older age , frailty , and dementia ) .


In previous work we developed a multicomponent intervention to prevent delirium in care homes , called Stop Delirium !


The intervention was based upon evidence from the research literature relating to the prevention of delirium and on strategies to change professional practice .


Before starting a large costly trial of Stop Delirium !


, this pilot study will test and help improve the design and feasibility of the trial protocol .


We plan to conduct a cluster randomised pilot trial in 14 care homes ( independent residential and nursing ) .


Following recruitment of residents ( over 60 years , consenting or with consultee agreement , able to communicate in English , and not in palliative care ) participating homes will be randomised , stratified by size of home and proportion of residents with dementia .


Stop Delirium !


will be delivered to intervention homes over 16 months , with controls receiving usual care .


The primary outcome measure will be the presence of delirium on any day during a one-month post-intervention period.We will collect data to determine 1 ) recruitment and attrition rates , 2 ) feasibility of various outcomes measurements , and 3 ) feasibility of capturing health resource use ( resident diaries and by examining health records ) .


We will estimate the between-cluster variation for the primary outcome , delirium occurrence .


This pilot study will refine methods for the definitive trial .


The lessons learnt will also contribute to implementing National Institute for Health and Clinical Excellence ( NICE ) delirium guidelines , which recommend multicomponent interventions for delirium prevention .


ISRCTN27972532 .


( 1 ) Compare tolerance of aerosolized spray versus syringe administration of topical anesthesia for transnasal flexible laryngoscopy ( TFL ) , ( 2 ) analyze cost-effectiveness of both techniques .


Prospective , blinded , randomized trial .


Tertiary academic laryngology practice .


One hundred and eight patients underwent TFL over 3 months .


Patients were randomized to receive equivalent dose 1:1 neosynephrine/4 % plain lidocaine mixture via aerosolized spray ( `` spray '' ) or application with 1-cc syringe ( `` syringe '' ) .


Patients and physicians independently rated comfort of TFL on 5-point scale ( 1 = not at all comfortable to 5 = very comfortable ) .


Data were collected on patient and endoscopist experience with TFL and reasons for poor tolerance of laryngoscopy .


Cost analyses of disposable spray tips and syringes were calculated .


Both patients and physicians reported very high tolerance of TFL .


Patient tolerance appears to be similar between spray - versus syringe-administered anesthesia , although study limitations preclude definitive analysis .


Poor tolerance of laryngoscopy was reported in 6.5 % with comparable distribution between anesthetic delivery methods .


There was no impact of patient prior experience with TFL , and there was no difference between anesthetic methods for TFL performed by resident , fellow , or attending .


The difference between costs of the disposable spray tip versus syringe was $ 1.32 per unit .


Use of a 1-cc syringe is an effective method to provide topical nasal anesthesia for TFL and saves $ 1.32 per unit compared to disposable spray tips .


In our practice , transition to syringe-administered nasal anesthesia is projected to save $ 1300 per 1000 patients , or an anticipated $ 1000 per year per physician , with excellent patient tolerance of TFL .


No randomized trials have so far investigated the cost effectiveness of different methods for implantation and use of central venous ports in oncology patients .


Overall , 403 patients eligible for receiving intravenous chemotherapy for solid tumours were randomly assigned to implantation of a single type of port , either through a percutaneous landmark access to the internal jugular vein , an ultrasound ( US ) - guided access to the subclavian vein , or a surgical cut-down access through the cephalic vein at the deltoid-pectoralis groove .


Insertion and maintenance costs were estimated by obtaining the charges for an average implant and use , while the costs of the management of complications were analytically assessed .


The total cost was defined as the purchase cost plus the insertion cost plus the maintenance cost plus the cost of treatment of the complications , if any .


A total of 401 patients were evaluable-132 with the internal jugular vein , 136 with the subclavian vein and 133 with the cephalic vein access .


No differences were found for the rate of early complications .


The US-guided subclavian insertion site had significantly lower failures .


Infections occurred in 1 , 3 , and 3 patients ( internal jugular , subclavian , and cephalic access , respectively ; p = 0.464 ) , whereas venous thrombosis was observed in 15 , 8 , and 11 patients , respectively ( p = 0.272 ) .


Mean cost for purchase , implantation , diagnosis and treatment of complications in each patient was <euro> 2,167.85 for subclavian US-guided , <euro> 2,335.87 for cephalic , and <euro> 2,384.10 for internal jugular access , respectively ( p = 0.0001 ) .


US real-time guidance to the subclavian vein resulted in the most cost-effective method of central venous port placement and use .


This study compares the effect of heliox-driven to that of air-driven bronchodilator therapy on the pulmonary function test ( PFT ) in patients with different levels of asthma severity .


One-hundred thirty-two participants were included in the study .


Participants underwent spirometry twice with bronchodilator testing on two consecutive days .


Air-driven nebulization was used one day and heliox-driven nebulization the other day in random order crossover design .


After a baseline PFT , each participant received 2.5 mg of albuterol sulfate nebulized with the randomized driving gas .


Post bronchodilator PFT was repeated after 30 min .


The next day , the exact same protocol was repeated , except that the other driving gas was used to nebulize the drug .


Participants were subgrouped and analyzed according to their baseline FEV ( 1 ) on day 1 : Group I , FEV ( 1 ) 80 % ; Group II , 80 % > FEV ( 1 ) > 50 % ; Group III , FEV ( 1 ) 50 % .


The proportion of participants with greater than 12 % and 200-mL increases from their baseline FEV ( 1 ) and the changes from baseline in PFT variables were compared between heliox-driven versus air-driven bronchodilation therapy .


The proportion of participants with > 12 % and 200-mL increases from their baseline FEV ( 1 ) with air - or heliox-driven bronchodilation was not different with respect to the proportion of participants with baseline FEV ( 1 ) 80 % ( 20 vs. 18 % , respectively ) and 80 % > FEV ( 1 ) > 50 % ( 36 vs. 43 % , respectively ) , but it was significantly greater with heliox-driven bronchodilation in participants with FEV ( 1 ) 50 % ( 43 vs. 73 % , respectively ; p = 0.01 ) .


Changes from baseline FVC , FEV ( 1 ) , FEV ( 1 ) / FVC , FEF ( 25-75 ) % , FEF ( max ) , FEF ( 25 ) % , FEF ( 50 ) % , and FEF ( 75 ) % were significantly larger with heliox-driven versus air-driven bronchodilation in participants with baseline FEV ( 1 ) 50 % .


Improvements in PFT variables are more frequent and profound with heliox-driven compared to air-driven bronchodilator therapy only in asthmatic patients with baseline FEV ( 1 ) 50 % .


A nasally applied cellulose powder is increasingly used in many countries as a remedy for allergic rhinitis .


In 2009 , a 4-week study in birch pollen-allergic children showed a reduction in nasal symptoms .


The best effect occurred on days with lower pollen counts .


The present study in grass pollen-allergic adults used the same basic design .


In May 2013 , a double-blind , placebo-controlled study was conducted in 108 patients with allergic rhinitis due to grass pollen ( 18-40 years of age ) .


SMS on mobile phones were used as reminders of treatment and reporting of symptom scores .


We found significant reductions in severity scores for sneezing , runny nose , stuffy nose and symptoms from eyes and lower airways , both separately and together ( all p < 0.001 ) .


Reflective opinion of effect and guess on treatment at follow-up visits ( both p < 0.001 ) confirmed a high efficacy .


No clinically significant adverse effects were reported .


The product provided significant protection against all seasonal allergic rhinitis symptoms from both upper and lower airways during the grass pollen season in an adult population .


The magnitude and scope of efficacy support the use of the product as an early choice in the treatment of allergic rhinitis .


To evaluate the value of angiography in clarifying the origin of the feeding arteries of primary retroperitoneal tumors and to explore the application of embolization therapy in the treating of primary retroperitoneal tumor .


68 patients with primary retroperitoneal tumor were randomized into conventional tumor resection group ( n = 35 ) and the preoperative embolization group ( n = 33 ) .


Some clinical data were compared between the preoperative embolization group and the routine operation group , including blood loss , blood transfusion , operation time and adverse reactions after embolization .


All the diagnoses were pathologically confirmed .


The origins of the tumor-feeding arteries were analyzed .


The clinical value of embolization in assisting the surgery as well as in making prognosis was assessed .


According to their location and size , primary retroperitoneal tumors had feeding arteries from different origins .


In this series of cases the tumor blood supply originated from the lumbar artery ( 81.8 % ) , internal iliac artery ( 45.5 % ) and adrenal artery ( 27.3 % ) .


In the preoperative embolization group and conventional surgery group , the blood loss was 912 ml vs. 2 500 ml ( P < 0.001 ) , the blood transfusion was 1 000 ml vs. 2 600 ml ( P < 0.001 ) , the operation time was 4.1 h vs. 5.9 h ( P < 0.001 ) , and the length of hospital stay was 12.5 d vs. 19.8 d ( P < 0.001 ) .


The origins of the feeding arteries in primary retroperitoneal tumors are very complex .


Preoperative embolization therapy may effectively reduce the intraoperative blood loss , postoperative adverse events , length of hospital stay , and facilitate the patients ' recovery .


To study potential exposures to crystalline silica and the number of work-related cases of silicosis occurring in Alberta .


Exposure data comprising 343 occupational samples were collected at 40 worksites across 13 industries .


To assess silicosis reporting , cases reported to the Alberta government , claims accepted by the Workers ' Compensation Board for work-related silicosis , and billings to Alberta Health for medical services with a diagnostic code for silicosis during a similar time period were compared .


Workers potentially over-exposed to airborne respirable crystalline silica were identified at most of the worksites evaluated .


There were large discrepancies in the number of silicosis cases found .


Many Alberta workers may be over-exposed to airborne respirable crystalline silica , and the incidence of work-related silicosis in Alberta may not be adequately represented by the official statistics .


Despite the use of embolic protection devices , no-reflow can still occur during saphenous vein grafts ( SVGs ) intervention .


High-dose intracoronary adenosine infusion preconditions the myocardium , improves coronary flow , and prevents no-reflow .


The role of high-dose intragraft adenosine infusion on protection of microvascular function and prevention of no-reflow has not been investigated


We investigated the cardioprotective effect of high-dose intragraft adenosine infusion , compared with placebo , on microvascular function and prevention of no-reflow during SVGs intervention .


We randomized 22 patients with SVGs stenoses to receive either a 10-min intragraft adenosine infusion ( 200 g/min ; total dose = 2,000 g ) or normal saline prior to stenting .


Average peak velocity ( APV ) , coronary flow velocity reserve ( CVR ) , thrombolysis in myocardial infarction ( TIMI ) frame count ( TFC ) , TIMI myocardial perfusion grade ( TMPG ) , and the rate of no-reflow were compared between the two groups before adenosine or saline infusions and after stenting


After stenting , hyperemic APV , CVR , and TMPG were significantly higher in the adenosine-treated group than in the control group ( 60 18 vs. 35 10 cm/sec ; 2.6 0.54 vs. 1.8 0.47 ; and 2.8 0.90 vs. 2.1 0.80 , respectively ; P < 0.05 .


TFC was significantly lower in the adenosine-treated group than in the control group ( 14 3.0 vs. 26 13 ; P < 0.05 ) .


In the control group , four patients ( 36 % ) developed no-reflow compared to none in the adenosine-treated patient ; P < 0.05 CONCLUSIONS : This study provides the first evidence that high-dose intragraft adenosine infusion compared with placebo protects microvascular function and prevents no-reflow during SVGs intervention .


Among surgical oncology patients , incisional surgical site infection is associated with substantially increased morbidity , mortality and healthcare costs .


Moreover , while adults undergoing pancreaticoduodenectomy with preoperative placement of an intrabiliary stent have a high risk of this type of infection , and wound protectors may significantly reduce its risk , no relevant studies of wound protectors yet exist involving this patient population .


This study will evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among adults undergoing pancreaticoduodenectomy with preoperatively-placed intrabiliary stents .


This study will be a parallel , dual-arm , randomised controlled trial that will utilise a more explanatory than pragmatic attitude .


All adults ( 18years ) undergoing a pancreaticoduodenectomy at the Foothills Medical Centre in Calgary , Alberta , Canada with preoperative placement of an intrabiliary stent will be considered eligible .


Exclusion criteria will include patient age < 18years and those receiving long-term glucocorticoids .


The trial will employ block randomisation to allocate patients to a commercial dual-ring wound protector ( the Alexis Wound Protector ) or no wound protector and the current standard of care .


The main outcome measure will be the rate of surgical site infection as defined by the Centers for Disease Control and Prevention criteria within 30days of the index operation date as determined by a research assistant blinded to treatment allocation .


Outcomes will be analysed by a statistician blinded to allocation status by calculating risk ratios and 95 % CIs and compared using Fisher 's exact test .


This will be the first randomised trial to evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among patients undergoing pancreaticoduodenectomy .


Results of this study are expected to be available in 2016/2017 and will be disseminated using an integrated and end-of-grant knowledge translation strategy .


ClinicalTrials.gov identifier NCT01836237 .


Examine the relationship of demographics and health conditions , alone and in combination , on objective measures of cognitive function in a large sample of community-dwelling older adults .


Baseline data from 2,782 participants in the Advanced Cognitive Training in Independent and Vital Elderly ( ACTIVE ) study were used to examine relationships of demographics and health conditions with composite scores of memory , reasoning , and speed of processing .


Younger age , increased education , and White race were independently associated with better performance in each cognitive domain after adjusting for gender and health conditions .


Male gender , diabetes , and suspected clinical depression were associated with poorer cognitive functioning ; suspected clinical depression was associated with lower reasoning and diabetes and history of stroke with slower speed of processing .


Age , education , and race are consistently associated with cognitive performance in this sample of older community-dwelling adults .


Diabetes , stroke , and suspected clinical depression had independent but weaker effects on cognition .


Functional constipation ( FC ) is a common functional gastrointestinal disorders ( FGIDs ) which has a major impact on the quality of life .


Acupuncture is widely used as an alternative and complementary medicine ( CAM ) for FC , but the available evidence of its effectiveness is scarce .


Therefore , we will perform a randomized controlled trial to determine whether acupuncture improves symptom and quality of life in FC patients more effectively than sham acupuncture or gastrointestinal prokinetic agent .


This article will report the protocol of the trial .


The current trial is a multicenter , randomized , three-arm controlled study undergoing in China .


About 243 people who aged from 18 to 65years with FC will be recruited in this study .


These participants will be randomly allocated into three treatment groups , including electro-acupuncture ( EA ) , Mosapride ( M ) and Mosapride & Sham Electro-acupuncture ( MS ) groups in a 1:1:1 ratio .


Both the EA and sham EA receives 16 sessions of needling at Quchi ( LI11 ) and Shangjuxu ( ST37 ) during 4weeks of treatment , and a follow-up period of 4weeks .


These groups will be compared on the primary outcomes of the number of times of defecation at baseline and 2 , 4 , 8weeks after randomization .


The secondary outcome measures include : stool consistency , intensity of defecating difficulty , MOS item Short Form health survey ( SF-36 ) , Self-Rating Anxiety Scale ( SAS ) , Self-rating Depression Scale ( SDS ) , and the validated Patient Assessment of Constipation Quality of Life ( PAC-QOL ) .


These outcomes are measured at baseline and 2 , 4weeks after randomization , but SF-36 is measured at baseline and 4weeks after randomization .


This study will supply significant evidence for using acupuncture to treat FC , and will help us to observe whether it is a therapeutic effect rather than a placebo effect .


The Intercollegiate Surgical Curriculum now recommends that cardiac surgical trainees should be able to understand and interpret transesophageal echocardiography images .


However , cardiac surgical trainees receive limited formal transesophageal echocardiography training .


The objective of this study was to assess the impact of simulation-based teaching versus more traditional operating room teaching on transesophageal echocardiography knowledge in cardiac surgical trainees .


A total of 25 cardiac surgical trainees with no formal transesophageal echocardiography learning experience were randomly assigned by computer to a study group receiving simulation-based transesophageal echocardiography teaching via the Heartworks ( Inventive Medical , London , UK ) simulator ( n = 12 ) or a control group receiving transesophageal echocardiography teaching during elective cardiac surgery ( n = 13 ) .


Each subject undertook a video-based test composed of 20 multiple choice questions on standard transesophageal echocardiography views before and after teaching .


There was no significant difference in the pretest scores between the 2 groups ( P = .89 ) .


After transesophageal echocardiography teaching , subjects within each group demonstrated a statistically significant improvement in transesophageal echocardiography knowledge .


Although the subjects within the simulation group outperformed their counterparts in the operating room teaching group in the post-test scores , this difference was not significant ( P = .14 ) .


Despite the familiarity with transesophageal echocardiography images during surgery , subjects in the simulation group performed at least as well as those in the operating room group .


Surgical trainees will benefit from formal transesophageal echocardiography teaching incorporated into their training via either learning method .


The purpose of this study is to explore the applicability of a psychosocial intervention in childhood cancer patients .


This individualized structured psychosocial program to enhance social-emotional functioning and coping with disease-related effects includes six sessions for children and two sessions for parents .


This program was part of a combined intervention with physical exercise .


Questionnaires are used to evaluate completion of the psychosocial intervention , coping and satisfaction with the psychosocial intervention by patients and psychologists , and ranking of the individual topics by patients , parents , and psychologists .


Of the 30 patients ( mean age 13.0 ( SD 3.0 ) ; 53.3 % male ; 30 % still on treatment ) who participated in the psychosocial intervention , two dropped out due to medical complications and one due to lack of time ; 90 % completed the psychosocial intervention .


Overall , patients liked participation in the intervention ( 4.2 on a 5-point scale ; SD 0.8 ) and were positive about the psychologists ( 8.1 on a 10-point scale ; SD 1.3 ) .