In Huntington disease ( HD ) patients receiving rivastigmine treatment improvement of behavioral symptoms and of cognitive function ( assessed with screening diagnostic instruments ) has been reported .


The aim of the present study was to verify such improvement in cognitive function by cognitive function assessment with a detailed neuropsychological battery covering all relevant cognitive systems expected to be impaired in early phase HD .


Eighteen ( 18 ) HD patients entered the study and were randomly allocated to the rivastigmine and placebo group .


All subjects underwent neuropsychological assessment at baseline .


Follow-up neuropsychological assessment was applied after 6 months of rivastigmine or placebo treatment .


Eighteen ( 18 ) healthy controls entered the study to control for practice effect and underwent neuropsychological assessment at baseline and after 6 months , without treatment .


The neuropsychological battery consisted of assessment tools that are sensitive to cognitive impairment seen in early phase HD : CTMT , SDMT , Stroop ( attention and information control ) , RFFT , TOL , Verbal fluency ( executive functioning ) , CVLT-II , RCFT ( learning and memory ) .


Effect of rivastigmine and possible effect of practice was assessed using the mixed ANOVA model .


No statistically significant effect of rivastigmine treatment on cognitive function in HD patients was detected .


There was no evidence for practice or placebo effect .


Detailed neuropsychological assessment did not confirm previously reported effect of rivastigmine treatment on cognitive function in HD patients .


The limitations of our study are , in particular , small sample size and the lack of a single measure of relevant cognitive functioning in HD patients .


Instead of focusing solely on statistical significance , a clinical relevance study is proposed to clarify the issue of rivastigmine effects in HD .


Smoking is the main preventable cause of morbidity and mortality in our region , it being the main causative agent of chronic obstructive pulmonary disease .


There still is no consensus on the use of spirometry as a strategy for smoking cessation , given that there is insufficient scientific evidence from high quality studies to recommend the use of this technique .


This is to be a randomized , multicentre , open-label clinical trial .


A total of 444 smokers over 40 years of age will be recruited by 39 general practitioners from 22 health centers .


Primary objective of this study is to assess the effectiveness of spirometry together with information regarding the test for smoking cessation after 1 year in smokers over 40 years of age with a more than 10 pack-year history and no previous diagnosis of chronic obstructive pulmonary disease .


Groups of 45 patients who smoke will be randomly selected from the lists of the participating doctors .


The names will be sent to the corresponding doctors who will contact candidate patients and assess whether they meet the selection criteria .


Patients who meet these criteria will be randomly allocated to an intervention or control group .


For patients in both groups , a nurse will conduct an interview and perform a spirometry test to measure forced vital capacity .


Then , all patients will be referred for an appointment with their doctor for brief anti-smoking intervention , patients from the intervention group additionally being informed about the result of the spirometry test .


After 1 year , smoking status will be assessed and , in those who report that they have quit smoking , abstinence will be confirmed by co-oximetry .


Data will be analyzed on an intention-to-treat basis using the chi-squared test for outcomes and binary logistic regression if it is considered to be necessary to adjust for confounding variables .


Performing a spirometry test and providing information on pulmonary function may increase awareness of the effect of smoking among smokers who are asymptomatic or have few symptoms and make them decide to quit .


Specifically , in patients with chronic obstructive pulmonary disease it might increase levels of motivation to quit smoking in early stages of the disease .


If this strategy were to be effective , it could be included in the health promotion activities offered in primary care .


ClinicalTrials.gov Identifier : NCT01821885 .


Research is needed on initial smoking abstinence and relapse risk .


This study aims to investigate the effects of different durations of initial abstinence on sensitivity to smoking-related stimuli and response inhibition in the context of a larger battery of outcome measures .


Smokers were randomly assigned to receive payment contingent on smoking abstinence across all 15 study days ( 15C ) or just the final 2days ( 2C ) .


Smoking status and subject ratings were assessed daily .


Participants completed fMRI sessions at baseline and day 14 during which they completed craving ratings after exposure to smoking-related and neutral stimuli and performed a response inhibition task .


On day 15 , participants completed a smoking preference session involving 20 exclusive choices between smoking and money .


The payment contingencies were effective in producing greater smoking abstinence in the 15C vs. 2C conditions .


Ratings of withdrawal decreased , while ratings of ease and confidence in abstaining increased in the 15C vs. 2C conditions across the 15-day study .


15C participants were less likely to choose the smoking option in the preference session .


15C participants reported greater reductions in craving compared to the 2C participants in the presence of smoking-related and neutral stimuli ( i.e. , decreases in generalized craving ) , but no differences were noted in cue reactivity per se or in response inhibition .


Results systematically replicate prior observations that a period 2weeks of initial abstinence decreases the relative reinforcing effects of smoking and improves other outcomes associated with relapse risk compared to the initial day or two of a cessation effort , and extends them by underscoring the importance of generalized rather than cue-induced craving in relation to relapse risk during the initial weeks of smoking cessation .


The aim of this study was to evaluate the clinical results of non surgical knee distraction in patients with severe knee osteoarthritis .


forty female patients with severe knee osteoarthritis were randomly divided in two groups .


A standard physiotherapy treatment was applied to both groups and in one group it was accompanied with 20 min knee joint distraction .


The patients were treated for 10 sessions .


Clinical examination consisted of functional examination , completion of a quality of life questionnaire , pain scale , and assessment of joint mobility and joint edema .


The standard physiotherapy treatment accompanied by knee distraction resulted in significantly higher improvement in pain ( P = 0.004 ) , functional ability ( P = 0.02 ) , quality of life ( P = 0.002 ) and knee flexion range of motion ( p = 0.02 ) compared to the standard physiotherapy treatment alone post treatment and after 1 month follow up .


Adding knee distraction to standard physiotherapy treatment can result in further improvement in pain relief , increased functional ability and better quality of life in patients with severe knee osteoarthritis .


To compare the efficacy of the erlotinib versus gefitinib in the first-line treatment of patients with advanced EGFR mutation-positive NSCLC .


Fifty patients with untreated advanced EGFR mutation - positive NSCLC were randomly divided into gefitinib group ( n = 27 ) and erlotinib group ( n = 23 ) .


The progression-free survival , objective response rate and disease control rate were evaluated to compare the efficacy of gefitinib and erlotinib .


There were no significant differences in the objective response rate ( P = 0.711 ) and disease control rate ( P = 0.861 ) between the two groups .


The progression-free survival of gefitinib group and erlotinib group was 8.0 months and 10.0 months , respectively .


The efficacy of the two drugs was similar ( P = 0.293 ) .


There is no significant differences between gefitinib and erlotinib in the first-line treatment of patients with advanced EGFR mutation-positive NSCLC .


Recent research shows that advance care planning ( ACP ) for patients with chronic obstructive pulmonary disease ( COPD ) is uncommon and poorly carried out .


The aim of the present study was to explore whether and to what extent structured ACP by a trained nurse , in collaboration with the chest physician , can improve outcomes in Dutch patients with COPD and their family .


A multicentre cluster randomised controlled trial in patients with COPD who are recently discharged after an exacerbation has been designed .


Patients will be recruited from three Dutch hospitals and will be assigned to an intervention or control group , depending on the randomisation of their chest physician .


Patients will be assessed at baseline and after 6 and 12 months .


The intervention group will receive a structured ACP session by a trained nurse .


The primary outcomes are quality of communication about end-of-life care , symptoms of anxiety and depression , quality of end-of-life care and quality of dying .


Secondary outcomes include concordance between patient 's preferences for end-of-life care and received end-of-life care , and psychological distress in bereaved family members of deceased patients .


Intervention and control groups will be compared using univariate analyses and clustered regression analysis .


Ethical approval was received from the Medical Ethical Committee of the Catharina Hospital Eindhoven , the Netherlands ( NL42437 .060.12 ) .


The current project provides recommendations for guidelines on palliative care in COPD and supports implementation of ACP in the regular clinical care .


NTR3940 .


To compare the use of intralesional triamcinolone acetonide and its combination with 5 flourouracil in the treatment of keloid and hypertrophic scars in terms of reduction in initial height of the scar .


The randomised controlled trial was conducted at the Department of Plastic Surgery , King Edward Medical University , Lahore , from March 2011 to December 2012 .


It comprised patients of both genders having keloids or hypertrophic scars ( 1 cm to 5 cm in size ) having no history of treatment for the scars in preceding 6 months .


Those who were pregnant , planning pregnancy or lactating were excluded .


The subjects were divided into two groups : Group A received intralesional triamcinolone acetonide alone ; and Group B received triamcinolone acetonide + 5 flourouracil .


Eight injections were given at weekly interval .


Scars were assessed 4 weeks after the completion of treatment on a five-point scale .


SPSS 16 was used for statistical analysis .


The 150 subjects in the study were divided into two equal groups of 75 ( 50 % ) each .


Good to excellent results were seen in 51 ( 68 % ) cases in Group A compared to 63 ( 84 % ) in Group B. Frequency of complications was 18 ( 24 % ) and 6 ( 8 % ) in Group A and Group B respectively .


Combination of triamcinolone acetonide and 5 flourouracil is superior to triamcinolone acetonide therapy in the treatment of keloids and hypertrophic scars .


It is believed that local anesthetic injected to obtain circumferential spread around nerves produces a more rapid onset and successful blockade after some ultrasound-guided peripheral nerve blocks .


However , evidence demonstrating this point is limited only to the popliteal sciatic nerve block , which is relatively easy to perform by via a high-frequency linear transducer .


In the present study , we tested the hypothesis that multiple injections of local anesthetic to make circumferential spread would improve the rate of sensory and motor blocks compared with a single-injection technique for ultrasound-guided subgluteal sciatic nerve block , which is considered a relatively difficult block conducted with a low-frequency , curved-array transducer .


Ninety patients undergoing knee surgery were divided randomly into 2 groups to receive the ultrasound-guided subgluteal approach to sciatic nerve block with 20 mL of 1.5 % mepivacaine with epinephrine .


For group M ( the multiple-injection technique ) , the local anesthetic was injected to create circumferential spread around the sciatic nerve without limitation on the number of needle passes .


For group S ( the single-injection technique ) , the number of needle passes was limited to 1 , and the local anesthetic was injected to create spread along the dorsal surface of the sciatic nerve , during which no adjustment of the needle tip was made .


Sensory and motor blockade were assessed in double-blind fashion for 30 minutes after completion of the block .


The primary outcome was sensory blockade of all sciatic components tested , including tibial , superficial peroneal , and sural nerves at 30 minutes after injection .


Data from 86 patients ( 43 in each group ) were analyzed .


Block execution took more time for group M than group S.


The proportion of patients with complete sensory blockade of all sciatic components at 30 minutes after injection was significantly larger for group M than group S ( 41.9 % vs 16.3 % , P = 0.018 ) .


Complete motor blockade of foot and toes extension also was observed more frequently in group M than in group S ( 67.4 % vs 34.9 % , P = 0.005 and 51.2 % vs 25.6 % , P = 0.027 , respectively ) .


When ultrasound-guided subgluteal sciatic nerve block is conducted , multiple injections of local anesthetic to make a circumferential spread around the sciatic nerve improve the rate of sensory and motor blocks compared with a single injection .


Progressive loss of muscle and strength with age is often coincident with increases in adiposity , leading to a condition called sarcopenic obesity .


Studies have shown sarcopenic obese adults to be at higher risk for declines in physical function .


Despite this rising public health concern , no intervention studies currently exist in this population .


A total of 21 sarcopenic obese adults , 60 years or older , were randomized into two groups , strength/hypertrophy ( SH , n = 9 ) and high-speed circuit ( HSC , n = 8 ) and were trained for 15 weeks .


The primary outcome was the SPPB modified as a measure of physical function , assessed by assessors blinded to randomization .


Secondary outcomes were lower body and upper body power and strength , instrumental activities of daily living ( IADL ) , ratings of perceived exertion ( RPE ) , body fat % ( BF % ) , skeletal muscle index ( SMI ) , and grip strength ( GRP ) .


For the SPPB results favored HSC over SH ( 1.1 , 95 % CI ( -.1 to 2.4 ) , p = .08 ) and showed a moderate effect size ( Hedge g = 0.6 , 95 % CI ( -0.4 , 1.6 ) ) .


For secondary outcomes , lower body power ( mean difference = 158 W , 95 % CI ( 2 , 315 ) ; p = .01 ) and RPE ( mean difference = -1.5 , 95 % CI ( -2.9 , -0.12 ) ; p = .04 ) also favored HSC .


IADL , SMI , BF % , upper and lower body strength and upper body power , showed no statistically significant differences between groups .


Considering the moderate effect size , the large treatment effect shown by the upper limit of the 95 % CI , the low perceived exertion , and no adverse effects , HSC training should be further investigated with a larger sample size in sarcopenic obese adults .


Septal body hypertrophy , like inferior turbinate hypertrophy , can result in changes to the nasal cross-sectional area and resistance to airflow .


The aim of this study is to evaluate the efficacy of septal body volume reduction ( SBVR ) for the treatment of septal body hypertrophy in patients with nasal obstruction .


Prospective randomized study .


The study was conducted on two groups ( 51 patients ) with symptoms and signs of nasal obstruction associated with septal body and inferior turbinate hypertrophy that were refractory to medical therapy .


In the turbinoplasty only ( ITR ) group ( n = 25 ) , conventional turbinoplasty was only performed on the inferior turbinate .


In the septal body reduction ( SBR ) group ( n = 26 ) , concurrent bilateral microdebrider-assisted SBVR was performed during the turbinate surgery .


The nasal symptoms , including nasal obstruction , rhinorrhea , itching , and sneezing , had significantly improved at 3 months after treatment in both groups ( P < 0.001 ) .


Improvement of nasal obstruction in the SBR group was greater than that in the ITR group at 3 months ( P < 0.05 ) .


Acoustic rhinometry demonstrated a significant increase in the cross-sectional area and nasal volume in both groups 3 months after surgery .


The postoperative change in nasal volume was higher in the SBR group ( P < 0.05 ) .


No adverse reactions such as bleeding , infection , adhesions , or olfactory changes were encountered in the SBR group .


Combined SBVR and turbinoplasty appears to be more effective than turbinoplasty alone for the treatment of nasal obstruction in patients with inferior turbinate and septal body hypertrophy .


Since sugar-sweetened beverages ( SSB ) may contribute to the development of overweight in children , effective interventions to reduce their consumption are needed .


Here we evaluated the effect of a combined school - and community-based intervention aimed at reducing children 's SSB consumption by promoting the intake of water .


Favourable intervention effects on children 's SSB consumption were hypothesized .


In 2011-2012 , a controlled trial was conducted among four primary schools , comprising 1288 children aged 6-12 years who lived in multi-ethnic , socially deprived neighbourhoods in Rotterdam , the Netherlands .


Intervention schools adopted the ` water campaign ' , an intervention developed using social marketing .


Control schools continued with their regular health promotion programme .


Primary outcome was children 's SSB consumption , measured using parent and child questionnaires and through observations at school , both at baseline and after one year of intervention .


Significant positive intervention effects were found for average SSB consumption ( B -0.19 litres , 95 % CI -0.28 ; -0.10 ; parent report ) , average SSB servings ( B -0.54 servings , 95 % CI -0.82 ; -0.26 ; parent report ) and bringing SSB to school ( OR 0.51 , 95 % CI 0.36 ; 0.72 ; observation report ) .


This study supports the effectiveness of the water campaign intervention in reducing children 's SSB consumption .


Further studies are needed to replicate our findings .


Current Controlled Trials : NTR3400 .


Many children who lost parents in the 2008 earthquake in Sichuan Province , China , experienced symptoms of posttraumatic stress disorder ( PTSD ) and depression .


This randomized controlled study compared the treatment effectiveness of short-term cognitive-behavioral therapy ( CBT ) with a general supportive intervention and with a control group of nontreatment .


METHODS ; Thirty-two Chinese adolescents were randomly assigned to three treatment groups .


Participants were compared for psychological resilience ( Connor-Davidson Resilience Scale ) , symptoms of PTSD ( Children 's Revised Impact of Events Scale ) , and depression ( Center for Epidemiologic Studies Depression Scale ) at baseline , after treatment , and three-month follow-up .


CBT was effective in reducing PTSD and depressive symptoms and improved psychological resilience .


General support was more effective than no intervention in improving psychological resilience .


Short-term CBT group intervention seems to be a robust intervention for natural disaster victims .


Short-term CBT group intervention was more effective than the general supportive intervention and the no-treatment group in enhancing psychological resilience and reducing PTSD and depression among adolescents who had lost parents in the earthquake .


The general supportive intervention was effective only in improving psychological resilience .


To assess whether bipolar transurethral resection of the prostate using the TURis ( Olympus , Tokyo , Japan ) system demonstrates comparable efficacy and safety reporting 36months of follow-up findings .


The trial was registered at University hospital Medical Information Network Clinical Trials Registry in Japan ( trial number UMIN 000010801 ) .


Patients were randomly selected to undergo transurethral resection of the prostate using either the TURis or the conventional monopolar technique .


Primary end points were safety according to operation time , decline of sodium and hemoglobin levels , clot retention , and catheterization time .


Secondary end points were efficacy findings for patients after 36months of follow-up .


A total of 136 patients were enrolled .


Mean operation times were significantly prolonged in the TURis group ( 68.4 and 79.5 minutes for monopolar and TURis groups , respectively ; P = .048 ) .


Nosignificant differences in the decline of hemoglobin , hematocrit , and perioperative transfusion rates between groups were seen , whereas clot retention ( grade 2 ) after the treatment seemed to occur more often in the monopolar group ( 7 of 62 [ 12.3 % ] in monopolar group vs 1 of 63 [ 1/8 % ] in TURis group ; P = .061 ) .


No case presented symptomatic transurethral resection syndrome in either groups .


Continued efficacy at 36months after the treatment could be confirmed for the first time in TURis system , which also seems to be preferable as they produced more clinically favorable outcomes .


Nevertheless , the TURis system required significantly more resection time , which might not entirely be a panacea for the treatment of benign prostatic obstruction , especially for patients having larger prostatic volumes .


Acupuncture has been commonly used for preventing migraine attacks and relieving pain during a migraine , although there is limited knowledge on the physiological mechanism behind this method .


The objectives of this study were to compare the differences in brain activities evoked by active acupoints and inactive acupoints and to investigate the possible correlation between clinical variables and brain responses .


A randomized controlled trial and resting-state functional magnetic resonance imaging ( fMRI ) were conducted .


A total of eighty migraineurs without aura were enrolled to receive either active acupoint acupuncture or inactive acupoint acupuncture treatment for 8 weeks , and twenty patients in each group were randomly selected for the fMRI scan at the end of baseline and at the end of treatment .


The neuroimaging data indicated that long-term active acupoint therapy elicited a more extensive and remarkable cerebral response compared with acupuncture at inactive acupoints .


Most of the regions were involved in the pain matrix , lateral pain system , medial pain system , default mode network , and cognitive components of pain processing .


Correlation analysis showed that the decrease in the visual analogue scale ( VAS ) was significantly related to the increased average Regional homogeneity ( ReHo ) values in the anterior cingulate cortex in the two groups .


Moreover , the decrease in the VAS was associated with increased average ReHo values in the insula which could be detected in the active acupoint group .


Long-term active acupoint therapy and inactive acupoint therapy have different brain activities .


We postulate that acupuncture at the active acupoint might have the potential effect of regulating some disease-affected key regions and the pain circuitry for migraine , and promote establishing psychophysical pain homeostasis .


Chinese Clinical Trial Registry ChiCTR-TRC-13003635 .


Vegetables and fruits are rich in vitamins , minerals and , dietary fiber and contribute to the prevention and improvement of obesity and metabolic syndrome .


However , inadequate intake of vegetable and fruit is a concern in Japan.We therefore produced a juice mixture of fresh fruit and komatsuna ( Brassica rapa L. var .


perviridis : B. rapa ) with the aim to investigate the effects of this juice mixture on anthropometric data , blood parameters , and dietary intake differences .


This study was performed as a single blind and randomized controlled trial .


Subjects were 16 men ( mean age , 46.47.1 years ) , and they were divided into two groups ( control group and intervention group ) .


The intervention group consumed the juice mixture of fresh fruit and B. rapa .


The control group consumed commercial vegetable juice .


Subjects consumed juice twice a day throughout the weekday , for 4weeks .


We prepared both juices with an equivalent energy balance .


Weight and body mass index ( BMI ) of the control group after 4weeks were significantly increased compared with baseline values .


Serum total cholesterol ( T-Chol ) and low-density lipoprotein cholesterol ( LDL-Chol ) of the intervention group after 4weeks were significantly reduced compared with baseline values .


Furthermore , intake of total vegetables and fruits were significantly increased compared with baseline values in both groups .


Both vegetable juices contributed to improved intake of total vegetables and fruit .


Compared with the intake of commercial vegetable juice , the intake of fresh fruit and B. rapa juice is highly effective in reducing serum cholesterol .


Short-term intake of fresh fruit and B. rapa juice was shown to enhance cholesterol metabolism .


Sleep deprivation from extended duty hours is a common complaint for many occupations .


Caffeine is one of the most common countermeasures used to combat fatigue .


However , the benefits of caffeine decline over time and with chronic use .


Our objective was to evaluate the efficacy of anodal transcranial direct current stimulation ( tDCS ) applied to the pre-frontal cortex at 2 mA for 30 min to remediate the effects of sleep deprivation and to compare the behavioral effects of tDCS with those of caffeine .


Three groups of 10 participants each received either active tDCS with placebo gum , caffeine gum with sham tDCS , or sham tDCS with placebo gum during 30 h of extended wakefulness .


Our results show that tDCS prevented a decrement in vigilance and led to better subjective ratings for fatigue , drowsiness , energy , and composite mood compared to caffeine and control in sleep-deprived individuals .


Both the tDCS and caffeine produced similar improvements in latencies on a short-term memory task and faster reaction times in a psychomotor task when compared to the placebo group .


Interestingly , changes in accuracy for the tDCS group were not correlated to changes in mood ; whereas , there was a relationship for the caffeine and sham groups .


Our data suggest that tDCS could be a useful fatigue countermeasure and may be more beneficial than caffeine since boosts in performance and mood last several hours .


Colonic fermentation in patients with UC in remission was compared with that in matched healthy subjects on habitual diets and when dietary fibre was increased .


Fibre intake , faecal output of fibre ( measured as non-starch polysaccharide ( NSP ) ) , starch , microbiota and fermentation products , and whole gut transit time ( WGTT ) were assessed in association with habitual diet and when dietary intake of wheat bran ( WB ) - associated fibre and high amylose-associated resistant starch ( RS ) was increased in an 8-week , randomised , single-blind , cross-over study .


Despite a tendency to lower habitual fibre intake in UC patients , faecal NSP and starch concentrations were threefold higher than in controls , whereas concentrations of phenols and short-chain fatty acids , pH and WGTT were similar .


Increasing RS/WB intake was well tolerated .


In controls ( n = 10 ) , it more than doubled faecal NSP and starch excretion ( p = 0.002 for both ) , had no effect on NSP usage and reduced WGTT ( p = 0.024 ) .


In UC patients ( n = 19 ) , high intake of RS/WB tended to normalise gut transit , but did not increase the proportion of NSP fermented .


Increasing intake of RS/WB had little effect on faecal fermentation patterns or the structure of the microbiota .


However , faeces from the UC cohort had lower proportions of Akkermansia muciniphila and increased diversity within Clostridium cluster XIVa compared to controls .


Gut fermentation of NSP and starch is diminished in patients with UC .


This can not be explained by abnormal gut transit and was not corrected by increasing RS/WB intake , and may be due to abnormal functioning of the gut microbiota .


Australian New Zealand Clinical Trials Registry : ACTRN12614000271606 .


There have been few randomized control trials comparing the incidence of stent fracture and primary patency among different self-expanding nitinol stents to date .


The SMART CONTROL stent ( Cordis Corp , Miami Lakes , Florida , United States ) has a peak-to-valley bridge and inline interconnection , whereas the COMPLETE-SE stent ( Medtronic Vascular , Santa Rosa , California , United States ) crowns have been configured to minimize crown-to-crown interaction , increasing the stent 's flexibility without compromising radial strength .


Further , the 2011 ESC ( European society of cardiology ) guidelines recommend that dual antiplatelet therapy with aspirin and a thienopyridine such as clopidogrel should be administered for at least one month after infrainguinal bare metal stent implantation .


Cilostazol has been reported to reduce intimal hyperplasia and subsequent repeat revascularization .


To date , there has been no randomized study comparing the safety and efficacy of two different antiplatelet regimens , clopidogrel and cilostazol , following successful femoropopliteal stenting .


The primary purpose of our study is to examine the incidence of stent fracture and primary patency between two different major representative self-expanding nitinol stents ( SMART CONTROL versus COMPLETE-SE ) in stenotic or occlusive femoropopliteal arterial lesion .


The secondary purpose is to examine whether there is any difference in efficacy and safety between aspirin plus clopidogrel versus aspirin plus cilostazol for one month following stent implantation in femoropopliteal lesions .


This is a prospective , randomized , multicenter trial to assess the efficacy of the COMPLETE-SE versus SMART CONTROL stent for provisional stenting after balloon angioplasty in femoropopliteal arterial lesions .


The study design is a 2x2 randomization design and a total of 346 patients will be enrolled .


The primary endpoint of this study is the rate of binary restenosis in the treated segment at 12 months after intervention as determined by catheter angiography or duplex ultrasound .


This trial will provide powerful insight into whether the design of the COMPLETE-SE stent is more fracture-resistant or effective in preventing restenosis compared with the SMART CONTROL stent .


Also , it will determine the efficacy and safety of aspirin plus clopidogrel versus aspirin plus cilostazol in patients undergoing stent implantation in femoropopliteal lesions .


Registered on 2 April 2012 with the National Institutes of Health Clinical Trials Registry ( ClinicalTrials.gov identifier # NCT01570803 ) .


Entonox is a 50:50 combination of nitrous oxide and oxygen , which may be used to manage pain during colonoscopy .


The optimal mode of Entonox administration is unknown .


The aim of this study was therefore to compare continuous and as-required Entonox use .


Patients attending for screening colonoscopy at a single centre were randomized to continuous or as-required Entonox use .


The primary outcome measure was the patient 's overall pain rating at the time of discharge ( verbally administered numerical ratings scale , 0 = no pain and 10 = extreme pain ) .


Secondary outcome measures included the patients ' experience of pain during the colonoscopy ( rated every 2min ) , side effects and the need for rescue intravenous medications .


A total of 108 patients were randomized , and 100 completed the study ( 46 continuous , 54 as required ) .


The overall pain scores at discharge did not differ between those who used Entonox continuously and as required ( mean = 2.4 vs. 3.2 , P = 0.08 ) .


There were also no differences in the experience of pain during colonoscopy ( mean = 1.8 vs. 2.2 , P = 0.28 ; peak = 4.2 vs. 4.8 , P = 0.26 ; and area under curve = 23 vs. 30 , P = 0.24 ) .


Patients with high anxiety had greater overall pain scores ( mean = 3.7 vs. 2.4 , P = 0.03 ) .


Light headedness occurred more often with continuous Entonox use ( 48 vs. 21 % , P = 0.009 ) .


Among patients attending for screening colonoscopy , comfort ratings were similar in those using Entonox continuously and as required , but light headedness was more common with continuous use ( NCT identifier : 01865721 ) .


To assess which is the optimal protocol in terms of endometrial preparation prior to frozen-thawed embryo transfer ( FET ) in women with polycystic ovarian syndrome ( PCOS ) and to explore the effect in stimulated cycle with the addition of vaginal 17 - oestradiol .


Five hundred and seventy-six patients with PCOS were prepared for FET using artificial cycle induced with oestradiol and progesterone supplementation ( n = 291 ) and stimulated cycle induced by human menopausal gonadotrophin ( HMG ) within or without the addition of vaginal 17 - oestradiol ( n = 285 ) .


Then the FET was performed in a receptive endometrium .


Endometrial thickness was similar ( 9.03 1.65 vs. 9.12 1.58 , P > 0.05 ) in artificial and stimulated cycle .


The two protocols resulted in clinical pregnancy rate ( 41.0 % vs. 41.6 % , P > 0.05 ) , ongoing pregnancy rate ( 36.6 % vs. 34.7 % , P > 0.05 ) , live birth rate ( 30.0 % vs. 31.7 % , P > 0.05 ) , which were not statistically different .


Nevertheless , the cancelled cycle rate made a significant difference ( 2.2 % vs. 5.4 % , P < 0.05 ) .


There is no significant difference in the clinical pregnancy rate in HMG , HMG added with vaginal oestradiol and HMG switch to vaginal oestradiol group ( 42.6 % , 41.1 % , and 33.3 % , respectively ) .


The mean endometrial thickness , clinical pregnancy rate , ongoing pregnancy rate , live birth rate and implantation rate were similar in artificial and stimulated cycle for endometrial preparation prior to FET in PCOS .


It was fine to add vaginal 17 - oestradiol to stimulated cycle when necessary .


However , stimulated cycles had a significantly higher cancelled cycle rate .


We should follow the principles of individualization , securitization and optimization in endometrial preparation of the FET in patients with PCOS .


The aim of the study was to compare infants ' gastrointestinal tolerance of formulas supplemented with 2 different levels of galacto-oligosaccharides ( GOS ) versus a control formula ( CF ) or human milk .


Healthy , full-term infants ( n = 180 ) were enrolled in this 3-group controlled , double-blind , multicenter study , and a concurrently enrolled , nonrandomized human milk-fed group ( HM ) by 8 days of age .


Infants were randomized to be fed formula supplemented with either 4 g ( EF4 ) or 8 g ( EF8 ) GOS/L or a CF until day of life ( DOL ) 119 .


Infants were to be seen at DOL 14 , 35 , 56 , 84 , and 119 .


Parents were to record detailed 24-hour information about intake , tolerance to feedings , and stool patterns and consistency each day from enrollment to DOL 35 , and for 3 days before DOL 56 , 84 , and 119 .


Stool consistency was scored on a 5-point scale as watery ( 1 ) , loose/mushy , soft , formed , or hard ( 5 ) .


The mean stool consistency score was higher in the CF group throughout the study ( CF > EF8 and CF > HM for all study periods and CF > EF4 from DOL 15 to 35 , P < 0.05 ) .


There was a significantly higher percentage of watery stools in the EF8 versus the CF group from study day 1 ( SD 1 ) to DOL 14 ( P < 0.05 ) , but no differences between the groups in number of stools per day .


The percentage of feedings with spit up and/or vomiting within 1 hour after feeding was significantly lower for HM versus EF8 and CF from SD 1 to DOL 14 ( P < 0.05 ) .


In this clinical study , milk-based term infant formula ( Similac Advance ) with 4 g GOS/L was well-tolerated in terms of stool consistency and additional measures of gastrointestinal tolerance by newborn infants through the first 4 months of life .


Methylphenidate is a psychostimulant that has been used to relieve depressive symptoms in advanced cancer patients .


No studies compare its efficacy against placebo in this group of patients .


To explore the efficacy of methylphenidate compared with placebo in the relief of depressive symptoms in advanced cancer patients .


A multicentre , double-blind , randomised placebo-controlled clinical trial was undertaken comparing the efficacy of methylphenidate and placebo in depressive symptoms .


Advanced stage cancer patients were eligible if they scored at least two points on the Two Question Screening Survey for depression .


A reduction of at least two points on the Edmonton Symptom Assessment Scale for depression ( 0-10 ) was considered as a response .


Sixty-nine patients were included ( methylphenidate : n = 31 , placebo : n = 38 ) ; median daily dose of methylphenidate was 25 mg .


Fifty-eight patients ( 84 % ) who completed the first week of treatment were considered suitable for evaluation .


In the intention to treat analysis , there were 14/31 ( 45 % ) responses with methylphenidate and 10/38 ( 26 % ) responses with placebo ( difference : 19 % ; 95 % CI : 4 % to 39 % ; p = 0.10 ) .


With the Hospital Anxiety and Depression Scale , 11/19 ( 58 % ) patients with methylphenidate and 10/24 ( 42 % ) with placebo improved from a score compatible with depression in the first 7 days ( difference 16 % ; 95 % CI 13 % to 42 % ; p = 0.29 ) .


The proportion of patients indicating adverse effects was similar for both cohorts ( p = 0.99 ) .


Compared with the placebo , methylphenidate demonstrated a positive trend in the incidence of response for depressive symptoms in advanced cancer patients .


Depressive disorders are highly prevalent in the working population and are associated with excessive costs .


The evidence for effective worker-directed interventions for employees with depressive symptoms is limited .


Treating employees with depressive symptoms via the Internet before they report sick from work could be beneficial and cost saving .


In this study , we tested the effectiveness over the period of 1 year of a Web-based guided self-help intervention , called Happy@Work, for employees with depressive symptoms who were not on sick leave .


A two-arm randomized controlled trial comparing a worker-directed , Web-based , guided self-help intervention to care as usual ( CAU ) was carried out .


We recruited employees from 6 companies via the company 's Intranet and by putting up posters .


The inclusion criteria were elevated depressive symptoms as measured by a score 16 on the Center for Epidemiologic Studies Depression scale ( CES-D ) and not being on sick leave .


The intervention contained 6 lessons and consisted of problem-solving treatment and cognitive therapy .


Participants were asked to submit weekly assignments via the website after completion of a lesson and they received feedback from a coach via the website .


Self-report questionnaires on depressive symptoms ( CES-D ; primary outcome ) , burnout ( Maslach Burnout Inventory , MBI ) , work performance ( Health and Work Performance Questionnaire , HPQ ) , duration of absenteeism , and anxiety ( Hospital Anxiety and Depression Scale , HADS ; secondary outcomes ) , were completed at baseline , posttreatment , and at 6 - , and 12-month follow-up .


Several subgroup and per-protocol analyses were performed .


A total of 231 employees were randomized to either the intervention group ( n = 116 ) or to CAU ( n = 115 ) .


Completion of assessments varied between 54 % -74 % .


Improvement in depressive symptoms between baseline and posttreatment was shown in all participants and these effects sustained over time .


However , there were no differences between the 2 groups ( adjusted regression coefficient = 0.46 , 95 % CI -2.11 to 3.03 , P = .72 ; Cohen 's d = 0.05 ) .


Differences between groups were also not significant for the secondary outcomes .


No subgroups were identified to show differences between the groups , nor did we find a between-group effect in the per-protocol analyses .


This study showed that a worker-directed , Web-based , guided self-help intervention was not more effective than CAU in reducing depressive symptoms among employees with depressive symptoms who were not on sick leave over the period of 1 year .


An intervention for this specific target group might not be necessary because the recovery in the CAU group was comparable to the intervention group and sustained over a 12-month period .


Nederlands Trial Register ( NTR ) : NTR2993 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2993 ( Archived by WebCite at http://www.webcitation.org/6PL9pFC0n ) .


To evaluate the safety and efficacy of corneal collagen crosslinking ( CXL ) using a transepithelial technique to treat keratoconus .


Cornea and refractive surgery subspecialty practice .


Prospective clinical trial .


Transepithelial CXL was performed in eyes with keratoconus using proparacaine with benzalkonium chloride ( BAK ) 0.01 % to facilitate riboflavin absorption and riboflavin 0.10 % without dextran .


Eyes were randomized to receive ultraviolet-A treatment ( 365 nm , 3 mW/cm ( 2 ) ) with concurrent administration of riboflavin randomized to every 1 minute or every 2 minutes for 30 minutes .


The principal outcomes included uncorrected ( UDVA ) and corrected ( CDVA ) distance visual acuities and topography-derived maximum keratometry ( K ) values .


Patients were followed for 6 months .


Thirty eyes of 25 patients were treated .


The mean maximum K value flattened by 0.9 diopter ( D ) ( baseline 58.7 D ; 6 months 57.8 D ) ( P = .01 ) .


The maximum K worsened by 2.0 D or more in 1 patient .


The mean CDVA improved by 0.83 Snellen lines ( P = .03 ) .


One patient lost 2 lines of CDVA .


There were no differences in the UDVA , CDVA , or keratometry outcomes between the 1-minute instillation subgroup and the 2-minute instillation subgroup .


Transepithelial CXL resulted in a statistically significant improvement in maximum K values and CDVA at the 6-month follow-up .


Further follow-up is necessary to ascertain the ability of transepithelial CXL to achieve long-term stabilization of the cornea in eyes with keratoconus .


Inactivity is a primary factor related to childhood obesity , yet aerobic exercise has been shown to prevent weight gain and improve fitness in adolescents .


Moreover , children become less active during their summer break from school .


This study compared the effects of 4 and 8 weeks of supervised summer activity versus an unsupervised summer break on metabolic function and fitness in adolescents .


Twenty-two adolescents were divided into 4-week ( n = 6 , weight 48.114.9 kg , body fat 27.48.4 % ) and 8-week exercise groups ( n = 6 , weight 43.410.9 kg , body fat 28.512.8 % ) , that performed supervised , play-based physical activity , versus an age-matched 8 week control group that maintained their typical summer break ( n = 10 , weight 41.710.0 kg , body fat 23.78.0 % ) .


Anthropometrics , resting energy expenditure ( REE ) , resting heart rate ( RHR ) and peak aerobic capacity ( VO ( 2peak ) ) were evaluated before and after the intervention ( 4 or 8 weeks ) .


REE showed group differences in posttraining conditions ( the 4-week group vs. the control group , 1220169 vs. 1067144 kcal/die , and the 8-week group vs. the control group , 1202151 vs. 1067144 kcal/die , P = 0.047 ) , but RHR decreased ( pre-program vs. post program : 9722 vs. 808 beat/min , P = 0.001 ) and VO ( 2peak ) significantly increased ( pre-program vs. post program : 27.87.8 vs. 34.86.5 mL/kg/min , P = 0.001 ) in the 8-week group compared to the control group .


Eight weeks of supervised play-based activity increased REE and VO ( 2peak ) in adolescents with concomitant decreases in RHR .


These data suggest that this novel model of exercise prescription could be considered world-wide by clinicians to improve fitness base in adolescents and help to combat the growing epidemic of childhood obesity .


The aim of this study was to determine the relationship of high daily monosodium glutamate ( MSG ) consumption with glutamate concentrations in jaw muscle , saliva , and serum , and muscle pain sensitivity in healthy participants .


A randomized , double-blinded , placebo-controlled study was conducted to investigate the effect of repetitive consumption of high-dose MSG on glutamate concentration in the masseter muscles measured by microdialysis and muscle pain sensitivity .


In five contiguous experimental daily sessions , 32 healthy participants drank MSG ( 150mg/kg ) or NaCl ( 24mg/kg ) diluted with a 400mL soda .


The concentrations of glutamate before and after the ingestion were assessed in dialysate and plasma samples on the first and last days .


Saliva glutamate concentration was assessed every day .


Pressure pain threshold , pressure pain tolerance , autonomic parameters ( heart rate , systolic and diastolic blood pressures ) and reported side effects also were assessed .


No significant change was noted in the baseline concentration of glutamate in the masseter muscle , blood , or saliva , but the peak concentration in the masseter muscle increased significantly between day 1 and 5 .


A statistically significant increase in systolic and diastolic blood pressures after MSG administration was observed , as well as a significantly higher frequency of reports of nausea and headache in the MSG group .


No robust effect of MSG on muscle sensitivity was found .


Interstitial glutamate concentration in the masseter muscle is not highly disturbed by excessive repetitive intake of MSG in healthy man .


Inflammatory mediators are involved in the pathophysiology of neutrophilic bronchial disorders presenting with chronic productive cough .


Accumulating evidence indicates that prostanoids are key elements in the pathophysiology of these disorders .


However , little is known about the role of prostacyclin in neutrophilic bronchial inflammation .


The effect of beraprost , a chemically and biologically stable analog of prostacyclin , on cough response to inhaled capsaicin was examined in 14 patients with chronic bronchitis , a neutrophilic bronchial disorder , in a randomized , placebo-controlled crossover study .


Capsaicin cough threshold , defined as the lowest concentration of capsaicin eliciting five or more coughs , was measured as an index of the airway cough reflex sensitivity .


After a 2-week treatment with beraprost ( 80 g twice a day orally ) , the cough threshold was significantly ( P < .05 ) decreased as compared with placebo [ 12.2 ( geometric standard error of the mean [ GSEM ] 1.5 ) M vs. 24.4 ( GSEM 1.3 ) ] .


These findings indicate that prostacyclin is involved in the pathophysiology of cough reflex sensitivity in patients with chronic bronchitis , a frequently encountered neutrophilic bronchial disorder presenting with chronic productive cough .


The aim of this study was to compare the accuracy of placental - microglobulin-1 ( PAMG-1 ) , insulin-like growth factor binding protein-1 ( IGFBP-1 ) and nitrazine test to diagnose premature rupture of membranes .


A total of 120 pregnant women between 11 and 42 weeks with signs/symptoms of membrane rupture were eligible for our study .


These women were evaluated with the PAMG-1 , IGFBP-1 , and nitrazine tests .


In the 120 women , the sensitivity , specificity , positive predictive value , and negative predictive value of PAMG-1 , IGFBP-1 and nitrazine test were 100 % , 100 % , 100 % , and 100 % , 93.33 % , 98.89 % , 96.55 % and 97.80 % , and 93.33 % , 94.44 % , 84.85 % , and 97.7 % , respectively .


In a comparison of the PAMG-1 test and the nitrazine test , positive coincidence rate was 84.85 % , negative coincidence rate was 97.70 % , total coincidence rate was 94.17 % , and kappa value was 0.85 .


In a comparison of the PAMG-1 test and the IGFBP-1 test , the positive coincidence rate , negative coincidence rate and total coincidence rate were 96.55 % , 97.80 % , and 97.50 % , and kappa value was 0.93 .


PAMG-1 assay was the most accurate method to diagnose premature rupture of membranes with the highest sensitivity , specificity , positive predictive value and negative predictive value .


To evaluate the effectiveness of orally administered maropitant citrate in preventing vomiting after hydromorphone hydrochloride administration in dogs .


Randomized , blinded , prospective clinical study .


40 dogs with American Society of Anesthesiologists status of I or II , > 6 months of age , and weighing between 24 and 58.2 kg ( 52.8 and 128.04 lb ) .


Dogs were randomly selected to receive maropitant ( 2.0 to 4.0 mg/kg [ 0.9 to 1.8 mg/lb ] ) or placebo ( lactose monohydrate ) orally 2 hours prior to receiving hydromorphone ( 0.1 mg/kg [ 0.045 mg/lb ] , IM ) .


A blinded observer recorded the occurrence of vomiting or signs of nausea ( eg , salivation or lip-licking ) during a 30-minute period after hydromorphone administration .


Two-tailed Fisher exact tests were used to compare the incidences of vomiting and signs of nausea with or without vomiting between treatment groups .


Results-Of the 20 dogs receiving maropitant , none vomited but 12 ( 60 % ) developed signs of nausea .


Of the 20 dogs receiving placebo , 5 ( 25 % ) vomited and 11 ( 55 % ) developed signs of nausea ; overall , 16 of 20 ( 80 % ) dogs in the placebo treatment group vomited or developed signs of nausea .


Compared with the effects of placebo , maropitant significantly decreased the incidence of vomiting but not signs of nausea in dogs administered hydromorphone .


Among the 40 study dogs , the incidence of vomiting associated with hydromorphone administration was 25 % .


Oral administration of maropitant prevented vomiting but not signs of nausea associated with hydromorphone administration in dogs .


Whether heart failure ( HF ) increases the risk of venous thromboembolism ( VTE ) is not well established .


In the phase III MAGELLAN ( Multicenter , rAndomized , parallel Group Efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically iLL patients comparing rivaroxabAN with enoxaparin ) trial , extended-duration rivaroxaban was compared with standard-duration enoxaparin followed by placebo for VTE prevention in 8101 hospitalized acutely ill patients with or without HF .


The aim of this analysis was to evaluate the relationship between HF severity and the risk of VTE in MAGELLAN patients .


Hospitalized patients diagnosed with HF were included according to New York Heart Association class III or IV at admission ( n = 2593 ) .


HF severity was determined by N-terminal probrain natriuretic peptide ( NT-proBNP ) plasma concentrations ( median 1904 pg/mL ) .


Baseline plasma D-dimer concentrations ranged from 0.6 to 1.7 g/L for the less and more severe HF subgroups .


Patients with more severe HF had a greater incidence of VTE versus patients with less severe HF , with a significant trend up to Day 10 ( 4.3 % versus 2.2 % ; P = 0.0108 ) and Day 35 ( 7.2 % versus 4.1 % ; P = 0.0150 ) .


Multivariable analysis confirmed that NT-proBNP concentration was associated with VTE risk up to Day 10 ( P = 0.017 ) and D-dimer concentration with VTE risk up to Day 35 ( P = 0.005 ) .


The association between VTE risk and HF severity that was observed in the enoxaparin/placebo group was not seen in the extended-duration rivaroxaban group .


Patients with more severe HF , as defined by high NT-proBNP plasma concentration , were at increased risk of VTE .


NT-proBNP may be useful to identify high short-term risk , whereas elevated D-dimer may be suggestive of high midterm risk .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00571649 .


Aromatase inhibitor ( AI ) therapy results in substantial survival benefits for patients with hormone receptor-positive breast cancer .


The rates of poor adherence and discontinuation of AI therapy are high , primarily because of treatment-related toxicities like musculoskeletal pain .


Although pain-related symptoms may worsen during AI therapy , the authors hypothesized that nonpersistence with AI therapy was associated with symptoms that were present before treatment initiation .


Postmenopausal women initiating AI therapy who were enrolled in a prospective clinical trial completed questionnaires at baseline to assess sleep , fatigue , mood , and pain .


Reasons for treatment discontinuation during the first year of treatment were recorded .


Associations between baseline patient-reported symptoms and treatment discontinuation because of toxicity were identified using logistic regression .


Four hundred forty-nine patients were evaluable .


The odds of treatment discontinuation were higher in patients who reported a greater number of symptoms before AI initiation .


Baseline poor sleep quality was associated with early treatment discontinuation , with an odds ratio ( OR ) of 1.91 ( 95 % confidence interval [ CI ] , 1.26-2 .89 ; P = .002 ) .


Baseline presence of tired feeling and forgetfulness had similar ORs for discontinuation ( tired feeling : OR , 1.76 ; 95 % CI , 1.15-2 .67 ; P = .009 ; forgetfulness : OR , 1.66 ; 95 % CI , 1.11-2 .48 ; P = .015 ) .


An increasing total number of baseline symptoms was associated with an increased likelihood of treatment discontinuation , with an OR of 1.89 ( 95 % CI , 1.20-2 .96 ; P = .006 ) for 3 to 5 symptoms versus 0 to 2 symptoms .


Symptom clusters in breast cancer survivors that are present before the initiation of adjuvant AI therapy may have a negative impact on a patient 's persistence with therapy .


Interventions to manage these symptoms may improve breast cancer outcomes and quality of life .


Hereditary hemorrhagic telangiectasia ( HHT ) is a genetic disorder associated with abnormal angiogenesis and disabling epistaxis .


Tranexamic acid ( TA ) has been widely used in the treatment of these severe bleeds but with no properly designed trial .


To demonstrate the efficacy of TA in epistaxis in HHT patients and to explore its safety of use .


A randomized , placebo-controlled , double-blind , cross-over trial was conducted .


Participants were randomized to receive TA ( 3g a day ) then placebo or the opposite sequence .


The main analysis compared intra-individual mean duration of epistaxis under TA vs. placebo on a log scale .


The primary outcome was the mean duration of epistaxis per month , assessed with specific grids to be completed by participants .


The number of epistaxis episodes was recorded as a secondary outcome .


A total of 118 randomized patients contributed to the statistical analysis .


The mean duration of epistaxis per month was significantly shorter with TA than placebo ( 0.19 on the log scale ; SD = 0.07 ; P = 0.005 ) , corresponding to a decrease of 17.3 % ( 15.7 min ) in the duration of epistaxis per month ( CI 95 % , 5.5-27 .6 ) .


The median number of epistaxis episodes per month was 22.1 episodes in the placebo arm vs. 23.3 episodes in the TA arm .


No thrombophlebitis was observed .


In the ATERO study , we demonstrated a significant decrease in the duration of epistaxis in HHT patients taking TA .


No safety issues were recorded in our cohort of patients .


It has been proposed that royal jelly has antioxidant properties and may improve oxidative stress and glycemic control .


Therefore , we investigated the effects of royal jelly supplementation in diabetic females .


In this pilot , parallel design randomized clinical trial , 50 female volunteers with type 2 diabetes were randomly allocated to the supplemented ( 25 , cases ) and placebo ( 25 , cases ) groups , based on random block procedure produced by Random Allocation Software , given a daily dose of 1,000 mg royal jelly soft gel or placebo , respectively , for 8 weeks .


Before and after intervention , glycemic control indices , antioxidant and oxidative stress factors were measured .


After royal jelly supplementation , the mean fasting blood glucose decreased remarkably ( 163.0542.51 mg/dL vs. 149.6842.7 mg/dL ) .


Royal jelly supplementation resulted in significant reduction in the mean serum glycosylated hemoglobin levels ( 8.67 % 2.24 % vs. 7.05 % 1.45 % , P = 0.001 ) and significant elevation in the mean insulin concentration ( 70.2829.16 pmol/L vs. 86.4627.50 pmol/L , P = 0.01 ) .


Supplementation significantly increased erythrocyte superoxidase dismutase and glutathione peroxidase activities and decreased malondialdehyde levels ( P < 0.05 ) .


At the end of study , the mean total antioxidant capacity elevated insignificantly in both groups .


On the basis of our findings , it seems that royal jelly supplementation may be beneficial in controlling diabetes outcomes .


Further studies with larger sample size are warranted .


Evidence is scarce for the effectiveness of therapies for oesophageal cancer progressing after chemotherapy , and no randomised trials have been reported .


We aimed to compare gefitinib with placebo in previously treated advanced oesophageal cancer .


For this phase 3 , parallel , randomised , placebo-controlled trial , eligible patients were adults with advanced oesophageal cancer or type I/II Siewert junctional tumours , histologically confirmed squamous-cell carcinoma or adenocarcinoma , who had progressed after chemotherapy , with WHO performance status 0-2 , and with measurable or evaluable disease on CT scan .


Participants were recruited from 48 UK centres and randomly assigned ( 1:1 ) to gefitinib ( 500 mg ) or matching placebo by simple randomisation with no stratification factors .


Patients , clinicians , and trial office staff were masked to treatment allocation .


Treatment continued until disease progression , unacceptable toxicity , or patient choice .


The primary outcome was overall survival , analysed by intention to treat .


This trial is registered , number ISRCTN29580179 .


Between March 30 , 2009 , and Nov 18 , 2011 , 450 patients were randomly assigned to treatment groups ( one patient withdrew consent ; 224 patients allocated gefitinib and 225 allocated placebo included in analyses ) .


Overall survival did not differ between groups ( median 373 months , 95 % CI 323-450 , for gefitinib vs 367 months , 95 % CI 297-437 , for placebo ; hazard ratio [ HR ] 090 , 95 % CI 074-109 , p = 029 ) .


Among the prespecified patient-reported outcomes ( 110 patients on gefitinib and 121 on placebo completed both baseline and 4 week questionnaires and were included in analyses ) , odynophagia was significantly better in the gefitinib group ( adjusted mean difference -861 , 95 % CI -1449 to -273 ; n = 227 ; p = 0004 ) , whereas the other outcomes were not significantly improved compared with placebo : global quality of life ( 269 , 95 % CI -233 to 772 , n = 231 , p = 0293 ) , dysphagia ( -318 , 95 % CI -836 to 200 , n = 231 , p = 0228 ) , and eating ( -411 , 95 % CI -996 to 175 , n = 229 , p = 0168 ) .


Median progression-free survival was marginally longer with gefitinib than it was with placebo ( 157 months , 95 % CI 123-190 in the gefitinib group vs 117 months , 95 % CI 107-137 in the placebo group ; HR 080 , 95 % CI 066-096 , p = 0020 ) .


The most common toxicities were diarrhoea ( 36 [ 16 % ] of 224 patients on gefitinib vs six [ 3 % ] of 225 on placebo ) and skin toxicity ( 46 [ 21 % ] vs two [ 1 % ] ) , both mostly grade 2 .


The commonest grade 3-4 toxicities were fatigue ( 24 [ 11 % ] vs 13 [ 6 % ] patients ) and diarrhoea ( 13 [ 6 % ] vs two [ 1 % ] ) .


Serious adverse events were reported in 109 ( 49 % ) of 224 patients assigned to gefitinib and 101 ( 45 % ) of 225 on placebo .


54 ( 24 % ) of patients in the gefitinib group achieved disease control at 8 weeks , as did 35 ( 16 % ) of patients on placebo ( p = 0023 ) .


The use of gefitinib as a second-line treatment in oesophageal cancer in unselected patients does not improve overall survival , but has palliative benefits in a subgroup of these difficult-to-treat patients with short life expectancy .


Future research should focus on identification of predictive biomarkers to identify this subgroup of benefiting patients .


Cancer Research UK .


To explore the feasibility and safety on lung resection surgery with the combined method of microinjection acupuncture ( MIA ) and intravenous anesthesia instead of compound traditional acupuncture and drug anesthesia ( ADA ) .


Ninety cases of lung resection surgery were randomized into a general anesthesia group , a MIA group and a ADA group , 30 cases in each one .


In the general anesthesia group , before surgery , the intramuscular injection of atropine 0.5 mg was used ; during surgery , the anesthesia induction was followed with intravenous injection of fentanyl citrate , propofol and rocuronium bromide and the dosage was increased accordingly ; after surgery , the analgesia pump was applied .


In the MIA group , on the basis of general anesthesia , before anesthesia induction , the acupoint catgut embedding was applied to Jiaji ( EX-B 2 ) of T4 , T6 and T , , Feishui ( BL 13 ) , Xinshu ( BL 15 ) and Geshu ( BL 17 ) on the affected side and bilateral Quchi ( LI 11 ) and Zusanli ( ST 36 ) ; after surgery , the analgesia pump was applied .


In the ADA group , on the basis of general anesthesia , before !


anesthesia induction , electroacupuncture ( EA ) was applied to Hegu ( LI 4 ) , Neiguan ( PC 6 ) , Houxi ( SI 3 ) and Zhigou ( TE 6 ) for 30 min ; during surgery , EA and intravenous medication were combined at the same acupoints as those before surgery ; after surgery , moxibustion and the analgesia pump were applied in combination for analgesia .


In each group , the biological indices were monitored during surgery at 11 time points named T. ( before anesthesia I induction ) , T1 ( intubation in general anesthesia induction ) , T2 ( skin incision ) , T3 ( rib exposure in muscular incision ) T. ( chest open ) , T , ( lung removal ) , T6 ( drainage tube implantation ) , T7 ( chest closure ) , T ( muscular stitching ) , T , ( skin stitching ) and T0 ( extubation ) .


The actual dosage of anesthetics during surgery and the , dosage of fentanyl citrate in analgesia pump were quantified after surgery .


Results ( 1 ) In the MIA group and ADA group , the increased dosage of fentanyl citrate was less than that in the general anesthesia group [ ( 1.230.28 ) g .


kg-1 .


h-1 vs ( 2.40.54 g. kg-1 .


h-1 , ( 1.10.38 g .


h-1 , both P < 0.05 ] .


The increased dosage of propofol and rocuronium bromide was not different during surgery among the groups ( all P > 0.05 ) .


( 2 ) In the MIA group and ADA group , after surgery , the increased dosage of fentanyl citrate was less than that in the general anesthesia group [ ( 11.01.04 ) g/kg vs ( 15.41.52 g/kg , ( 11.51.38 g/kg vs ( 15.41.52 g/kg , both P < 0.05 ] , reducing by 25 % in comparison .


( 3 ) The differences in heart rate and blood pressure at 11 time points during surgery were not significant among the three groups ( all P > 0.05 ) .


n The combined method of MIA and intravenous anesthesia significantly reduces the dosage of intravenous anesthetics during and after lung resection surgery as compared with ADA , presenting the similar analgesic effect as simple intravenous medication and the good safety .


The combined method of MIA and intravenous anesthesia is much


A limited amount of data exists regarding the effect of lipoic acid ( LA ) , an oral antioxidant supplement , on cytokine profiles among multiple sclerosis ( MS ) patients .


We aimed to assess the effect of daily consumption of LA on the cytokine profiles in MS patients .


In this double-blind , placebo-controlled , randomized clinical trial , 52 relapsing-remitting MS patients with an age range of 18-50 years were recruited into 2 groups : LA consumption ( 1,200 mg/day ) or placebo .


Patients followed their prescribed supplements for 12 weeks .


Fasting blood samples for cytokine profile measurement were collected at baseline and after the intervention .


Anthropometric parameters were measured based on the standard guidelines .


INF - , ICAM-1 , TGF - and IL-4 were significantly reduced in the LA group compared to the placebo group [ ( INF - : 0.82 0.2 vs. 0.2 0.2 pg/ml , p < 0.0001 ) , ( ICAM-1 : 20.2 9.4 vs. 8 10 ng/ml , p = 0.0001 ) , ( TGF - : 103.1 20.2 vs. 54.9 26 ng/ml , p < 0.0001 ) and ( IL-4 : 0.1 0.1 vs. 1.02 1.7 ng/ml , p = 0.0112 ) ] .


No significant changes in TNF - , IL-6 , EDSS and MMP-9 were found between the LA and placebo groups ( p = 0.6 , p = 0.8 , p = 0.09 and p = 0.8 , respectively ) .


The results suggested that consumption of 1,200 mg LA per day beneficially affects several inflammatory cytokines including INF - , ICAM-1 TGF - and IL-4 .


Further investigations are needed to verify the beneficial role of LA on other cytokine profiles among MS patients .


Evidence demonstrates that physical exercise and psychological wellbeing are closely interlinked , particularly in older-aged women .


However , research investigating how different forms of exercise influence mental health in older-aged women is underdeveloped .


A randomized controlled trial ( N = 300 ) will assess the relative effectiveness of two different exercise programs ( whole-body vibration and Multicomponent Training ) for improving psychological wellbeing in older-aged women .


The following outcomes will be assessed at three time points ( that is , pre , post , and follow-up ) : psychological wellbeing , proactive attitude , quality of life , and happiness .


Results will have important implications for preventing psychological and physiological disease in older-aged women and for managing health-related costs for this population group .


Number NCT01966562 on Clinical Gov database the 8 October 2013 .


Targeted interventions to reduce the risk and increase the early detection of melanoma have the potential to save lives .


We aimed to assess the effect of such an intervention on patient prevention behavior .


We conducted a pilot clustered randomized controlled trial , comparing a targeted screening and education intervention with a conventional information-based campaign in 20 private surgeries in western France .


In the intervention group , 10 general practitioners identified patients at elevated risk for melanoma with a validated assessment tool , the Self-Assessment Melanoma Risk Score ( SAMScore ) , examined their skin , and counseled them using information leaflets .


In the control group , 10 general practitioners displayed a poster and the leaflets in their waiting room and examined patients ' skin at their own discretion .


The main outcome measures were sunbathing and skin self-examinations among patients at elevated risk , assessed 5 months later with a questionnaire .


Analyses were based on 173 patients .


Compared with control patients , intervention patients were more likely to remember the campaign ( 81.4 % vs 50.0 % , P = .0001 ) and to correctly identify their elevated risk of melanoma ( 71.1 % vs 42.1 % , P = .001 ) .


Furthermore , intervention patients had higher levels of prevention behaviors : they were less likely to sunbathe in the summer ( 24.7 % vs 40.8 % , P = .048 ) and more likely to have performed skin self-examinations in the past year ( 52.6 % vs 36.8 % , P = .029 ) .


The intervention was not associated with any clear adverse effects , although there were trends whereby intervention patients were more likely to worry about melanoma and to consult their general practitioner again about the disease .


The combination of use of the SAMScore and general practitioner examination and counseling during consultations is an efficient way to promote patient behaviors that may reduce melanoma risk .


Extending the duration of follow-up and demonstrating an impact on morbidity and mortality remain major issues for further research .


To compare the effectiveness of different methods of recall for repeat Pap smear among women who had normal smears in the previous screening .


Prospective randomized controlled study .


All community clinics in Klang under the Ministry of Health Malaysia .


Women of Klang who attended cervical screening and had a normal Pap smear in the previous year , and were due for a repeat smear were recruited and randomly assigned to four different methods of recall for repeat smear .


The recall methods given to the women to remind them for a repeat smear were either by postal letter , registered letter , short message by phone ( SMS ) or phone call .


Number and percentage of women who responded to the recall within 8 weeks after they had received the recall , irrespective whether they had Pap test conducted .


Also the numbers of women in each recall method that came for repeat Pap smear .


The rates of recall messages reaching the women when using letter , registered letter , SMS and phone calls were 79 % , 87 % , 66 % and 68 % , respectively .


However , the positive responses to recall by letter , registered letter , phone messages and telephone call were 23.9 % , 23.0 % , 32.9 % and 50.9 % , respectively ( p < 0.05 ) .


Furthermore , more women who received recall by phone call had been screened ( p < 0.05 ) compared to those who received recall by postal letter ( OR = 2.38 , CI = 1.56-3 .62 ) .


Both the usual way of sending letters and registered letters had higher chances of reaching patients compared to using phone either for sending messages or calling .


The response to the recall method and uptake of repeat smear , however , were highest via phone call , indicating the importance of direct communication .


When cats purr during examination it is difficult to perform auscultation .


The objective of this study was to determine the prevalence of purring in cats during examination , and identify interventions that could be used to stop purring .


Cats seen at a first opinion clinic were enrolled in the study and their purring status recorded .


Thirty of the purring cats were exposed to up to three different interventions in an attempt to stop purring in a randomised controlled trial including blowing at the ear , use of an ethanol-based aerosol near the cat and proximity to a running tap .


The 30 cats in the trial were subjected to a total of 54 attempts to stop purring , proximity to a running tap caused 17 of 21 ( 81 % ) cats to stop purring , blowing at the cat 's ears worked in 2 of 15 ( 13 % ) cats , spraying an aerosol close to the cat was effective in 9 of 18 ( 50 % ) cases .


In 2 cats ( 7 % ) , none of the interventions interrupted purring .


This study provides evidence that placing a purring cat near a running tap and in proximity to the discharge of an ethanol-based aerosol are effective measures to stop purring in order to allow auscultation .


To evaluate the safety of the concurrent combination of bevacizumab with adjuvant radiotherapy ( B-RT ) in breast cancer ( BC ) .


Multicentre , prospective study , of the toxicity of adjuvant radiotherapy ( RT ) alone or B-RT in patients with non-metastatic BC enrolled in randomized Phase 3 BEATRICE trial .


Early and late toxicities were assessed by the Common Terminology Criteria for Adverse Events v. 3.0 during and 12 months after the completion of RT. .


From 2007 to 2012 , 39 females received adjuvant B-RT and 45 received adjuvant RT alone .


Median follow-up was 21.5 months .


All patients had triple-negative non-metastatic BC and received adjuvant chemotherapy followed by RT. 90 % of the 39 females treated by concurrent B-RT received whole breast irradiation ( WBI ) with a boost and 4 ( 10 % ) received post-mastectomy RT. .


Lymph node RT was delivered in 49 % of the females with internal mammary chain irradiation .


The mean duration of bevacizumab was 11.7 months .


38 ( 84 % ) females treated by RT alone received WBI with a boost and 16 % of the females received post-mastectomy RT. .


Lymph node RT was delivered in 47 % of the females with internal mammary chain RT in 31 % .


Grade 3 acute dermatitis was observed in 9 % of patients receiving B-RT and 5 % of patients receiving RT alone with no significant difference .


1 year after the completion of RT , the most common late grade 1-2 toxicities in the B-RT group were pain ( 18 % ) , fibrosis ( 8 % ) and telangiectasia ( 5 % ) .


The concurrent bevacizumab with locoregional RT is associated with acceptable early and late 1-year toxicities in patients with BC .


The largest series of this association .


To determine the efficacy and toxicity of higher dose versus standard dose intravenous methotrexate ( MTX ) and pulses of high-dose cytosine arabinoside with asparaginase versus standard dose cytosine arabinoside and teniposide during intensified continuation therapy for higher risk pediatric B-precursor acute lymphoblastic leukemia ( ALL ) .


From 1994 to 1999 , the Pediatric Oncology Group conducted a randomized phase III clinical trial in higher risk pediatric B-precursor ALL .


A total of 784 patients were randomized in a 22 factorial design to receive MTX 1 g/m versus 2.5 g/m and to cytosine arabinoside/teniposide versus high-dose cytosine arabinoside/asparaginase during intensified continuation therapy .


Patients receiving standard dose MTX had a 5-year disease-free survival ( DFS ) of 71.82.4 % ; patients receiving higher dose MTX had a 5-year DFS of 71.72.4 % ( P = 0.55 ) .


Outcomes on cytosine arabinoside/teniposide ( DFS of 70.42.4 ) were similar to higher dose cytosine arabinoside/asparaginase ( DFS of 73.12.3 % ) ( P = 0.41 ) .


Overall survival rates were not different between MTX doses or cytosine arabinoside/teniposide versus cytosine arabinoside/asparaginase .


Increasing MTX dosing to 2.5 g/m did not improve outcomes in higher risk pediatric B-precursor ALL .


Giving high-dose cytarabine and asparaginase pulses instead of standard dose cytarabine and teniposide produced nonsignificant differences in outcomes , allowing for teniposide to be removed from ALL therapy .


To evaluate how a genomic classifier ( GC ) that predicts the risk of metastasis after prostatectomy would impact adjuvant treatment recommendations made by radiation oncologists and urologists .


The 2 specialties often disagree about postprostatectomy adjuvant treatment recommendations .


Twenty-six radiation oncologists and 20 urologists with genitourinary oncology expertise reviewed de-identified clinical results from 11 patients after radical prostatectomy and made adjuvant treatment recommendations .


The same cases were later randomized and reassigned , and treatment recommendations were made using the clinical information and GC test results together .


Using clinical information alone , observation was recommended in 42 % of decisions made by urologists vs 23 % by radiation oncologists ( P < .0001 ) .


The GC test results altered 35 % and 45 % of treatment recommendations made by radiation oncologists and urologists , respectively .


Multivariate analysis showed GC risk was the strongest factor influencing treatment recommendations by both specialties , with an adjusted odds ratio of 4.17 ( 95 % confidence interval [ CI ] , 2.26-7 .70 ) and 6.51 ( 95 % CI , 4.29-9 .88 ) for radiation oncologists and urologists , respectively .


GC results indicating high metastatic risk resulted in intensification of treatment , whereas low metastatic risk resulted in less aggressive recommendations .


The GC results increased interdisciplinary agreement in treatment recommendations , as the odds of a recommendation for adjuvant treatment by urologists vs radiation oncologists increased from 0.27 ( 95 % CI , 0.17-0 .44 ) to 0.46 ( 95 % CI , 0.29-0 .75 ) after results of the GC test were available .


The GC test significantly influenced adjuvant postprostatectomy treatment recommendations , reduced disagreement between radiation oncologists and urologists , and has the potential to enhance personalization of postprostatectomy care .


Nonmelanoma skin cancers , such as basal-cell carcinoma and squamous-cell carcinoma , are common cancers that are caused principally by ultraviolet ( UV ) radiation .


Nicotinamide ( vitamin B3 ) has been shown to have protective effects against damage caused by UV radiation and to reduce the rate of new premalignant actinic keratoses .


In this phase 3 , double-blind , randomized , controlled trial , we randomly assigned , in a 1:1 ratio , 386 participants who had had at least two nonmelanoma skin cancers in the previous 5 years to receive 500 mg of nicotinamide twice daily or placebo for 12 months .


Participants were evaluated by dermatologists at 3-month intervals for 18 months .


The primary end point was the number of new nonmelanoma skin cancers ( i.e. , basal-cell carcinomas plus squamous-cell carcinomas ) during the 12-month intervention period .


Secondary end points included the number of new squamous-cell carcinomas and basal-cell carcinomas and the number of actinic keratoses during the 12-month intervention period , the number of nonmelanoma skin cancers in the 6-month postintervention period , and the safety of nicotinamide .


At 12 months , the rate of new nonmelanoma skin cancers was lower by 23 % ( 95 % confidence interval [ CI ] , 4 to 38 ) in the nicotinamide group than in the placebo group ( P = 0.02 ) .


Similar differences were found between the nicotinamide group and the placebo group with respect to new basal-cell carcinomas ( 20 % [ 95 % CI , -6 to 39 ] lower rate with nicotinamide , P = 0.12 ) and new squamous-cell carcinomas ( 30 % [ 95 % CI , 0 to 51 ] lower rate , P = 0.05 ) .


The number of actinic keratoses was 11 % lower in the nicotinamide group than in the placebo group at 3 months ( P = 0.01 ) , 14 % lower at 6 months ( P < 0.001 ) , 20 % lower at 9 months ( P < 0.001 ) , and 13 % lower at 12 months ( P = 0.001 ) .


No noteworthy between-group differences were found with respect to the number or types of adverse events during the 12-month intervention period , and there was no evidence of benefit after nicotinamide was discontinued .


Oral nicotinamide was safe and effective in reducing the rates of new nonmelanoma skin cancers and actinic keratoses in high-risk patients .


( Funded by the National Health and Medical Research Council ; ONTRAC Australian New Zealand Clinical Trials Registry number , ACTRN12612000625875 . )


Anemia affects most pregnant African women and is predominantly due to iron deficiency , but antenatal iron supplementation has uncertain health benefits and can increase the malaria burden .


To measure the effect of antenatal iron supplementation on maternal Plasmodium infection risk , maternal iron status , and neonatal outcomes .


Randomized placebo-controlled trial conducted October 2011 through April 2013 in a malaria endemic area among 470 rural Kenyan women aged 15 to 45 years with singleton pregnancies , gestational age of 13 to 23 weeks , and hemoglobin concentration of 9 g/dL or greater .


All women received 5.7 mg iron/day through flour fortification during intervention , and usual intermittent preventive treatment against malaria was given .


Supervised daily supplementation with 60 mg of elemental iron ( as ferrous fumarate , n = 237 women ) or placebo ( n = 233 ) from randomization until 1 month postpartum .


Primary outcome was maternal Plasmodium infection at birth .


Predefined secondary outcomes were birth weight and gestational age at delivery , intrauterine growth , and maternal and infant iron status at 1 month after birth .


Among the 470 participating women , 40 women ( 22 iron , 18 placebo ) were lost to follow-up or excluded at birth ; 12 mothers were lost to follow-up postpartum ( 5 iron , 7 placebo ) .


At baseline , 190 of 318 women ( 59.7 % ) were iron-deficient .


In intention-to-treat analysis , comparison of women who received iron vs placebo , respectively , yielded the following results at birth : Plasmodium infection risk : 50.9 % vs 52.1 % ( crude difference , -1.2 % , 95 % CI , -11.8 % to 9.5 % ; P = .83 ) ; birth weight : 3202 g vs 3053 g ( crude difference , 150 g , 95 % CI , 56 to 244 ; P = .002 ) ; birth-weight-for-gestational-age z score : 0.52 vs 0.31 ( crude difference , 0.21 , 95 % CI , -0.11 to 0.52 ; P = .20 ) ; and at 1 month after birth : maternal hemoglobin concentration : 12.89 g/dL vs 11.99 g/dL ( crude difference , 0.90 g/dL , 95 % CI , 0.61 to 1.19 ; P < .001 ) ; geometric mean maternal plasma ferritin concentration : 32.1 g/L vs 14.4 g/L ( crude difference , 123.4 % , 95 % CI , 85.5 % to 169.1 % ; P < .001 ) ; geometric mean neonatal plasma ferritin concentration : 163.0 g/L vs 138.7 g/L ( crude difference , 17.5 % , 95 % CI , 2.4 % to 34.8 % ; P = .02 ) .


Serious adverse events were reported for 9 and 12 women who received iron and placebo , respectively .


There was no evidence that intervention effects on Plasmodium infection risk were modified by intermittent preventive treatment use .


Among rural Kenyan women with singleton pregnancies , administration of daily iron supplementation , compared with administration of placebo , resulted in no significant differences in overall maternal Plasmodium infection risk .


Iron supplementation led to increased birth weight .


clinicaltrials.gov Identifier : NCT01308112 .


The recent Danish Multicentre Randomized Trial on Single-Lead Atrial ( AAIR ) Pacing versus Dual-Chamber ( DDDR ) Pacing in Sick Sinus Syndrome ( DANPACE ) suggested DDDR pacing as standard care .


However , previous findings supported the routine use of AAIR pacing .


This study investigated the cost-effectiveness of DDDR pacing compared with AAIR pacing for sick sinus syndrome .


A decision-analytical model based on patient-level data from three randomized trials was designed from the Danish healthcare system 's perspective .


The main outcomes were lifetime costs , quality-adjusted lifeyears ( QALYs ) , and net monetary benefit .


Quality-adjusted lifeyears were calculated by utilizing community-based preferences .


Costs were calculated by utilizing the extensive data on resource consumption , from the DANPACE trial .


Data were pooled and adjusted for baseline differences .


Dual-chamber pacing was shown to be cost-effective in all the analyses using a willingness-to-pay ( WTP ) threshold of 20,000 / QALY , and most analyses using a WTP of 30,000 / QALY .


When pooling the data and adjusting for baseline differences , Monte Carlo simulations revealed a 51-71 % probability of DDDR pacing being cost-effective at a WTP of 20,000 / QALY , and a 42-58 % probability at a WTP of 30,000 / QALY .


Dual-chamber pacing was most likely to be cost-effective among elderly patients with comorbidity .


The expected value of perfect information was low and initiation of additional publicly funded Danish trials was discouraged .


Dual-chamber pacing is likely to be a cost-effective treatment for sick sinus syndrome patients .


This study looks at the effect of immediate session-by-session feedback using short questionnaires for evaluating outcome of and alliance in the therapy .


Research data strongly suggests that using this feedback informed treatment improves the outcome of therapy .


However , until now , this method of Miller and Duncan has only been examined in clients ( generally students ) with mild problems and in partner counselling .


The question addressed by this study is whether immediate feedback is also effective when applied during crisis intervention and subsequent brief therapy in a psychiatric patient population in emergency situations .


It also looks at whether ` feedback-informed treatment ' affects the quality of the alliance .


To test the hypotheses , all patients seeking help from the Crisis Intervention & Brief Therapy Team over a two-year period will be followed throughout their treatment up to a maximum of six months and a follow-up period of three months after ending the treatment .


Patients are randomly assigned to two conditions : treatment without feedback and treatment with immediate feedback for each session .


The therapists all operate in both conditions and so they deliver both treatments .


An estimated total of 180 patients , aged 18years and over , will be included in the study .


The aim of this study is to make clear whether , and to what extent , systematic feedback from the patient in this target group during therapy determines the course and outcomes of therapy .


We also look at whether , and to what extent , the quality of the alliance and the motivation of the person delivering treatment with respect to the instruments play a role .


NTR3168 .


To report the long-term results of the ARO 95-06 randomized trial comparing hyperfractionated accelerated chemoradiation with mitomycin C/5-fluorouracil ( C-HART ) with hyperfractionated accelerated radiation therapy ( HART ) alone in locally advanced head and neck cancer .


The primary endpoint was locoregional control ( LRC ) .


Three hundred eighty-four patients with stage III ( 6 % ) and IV ( 94 % ) oropharyngeal ( 59.4 % ) , hypopharyngeal ( 32.3 % ) , and oral cavity ( 8.3 % ) cancer were randomly assigned to 30Gy/2Gy daily followed by twice-daily 1.4 Gy to a total of 70.6 Gy concurrently with mitomycin C/5-FU ( C-HART ) or 16Gy/2Gy daily followed by twice-daily 1.4 Gy to a total dose of 77.6 Gy alone ( HART ) .


Statistical analyses were done with the log-rank test and univariate and multivariate Cox regression analyses .


The median follow-up time was 8.7 years ( 95 % confidence interval [ CI ] : 7.8-9 .7 years ) .


At 10years , the LRC rates were 38.0 % ( C-HART ) versus 26.0 % ( HART , P = .002 ) .


The cancer-specific survival and overall survival rates were 39 % and 10 % ( C-HART ) versus 30.0 % and 9 % ( HART , P = .042 and P = .049 ) , respectively .


According to multivariate Cox regression analysis , the combined treatment was associated with improved LRC ( hazard ratio [ HR ] : 0.6 [ 95 % CI : 0.5-0 .8 ; P = .002 ] ) .


The association between combined treatment arm and increased LRC appeared to be limited to oropharyngeal cancer ( P = .003 ) as compared with hypopharyngeal or oral cavity cancer ( P = .264 ) .


C-HART remains superior to HART in terms of LRC .


However , this effect may be limited to oropharyngeal cancer patients .


To compare the rates of urinary incontinence ( UI ) and other complications of subtotal abdominal hysterectomy ( SAH ) with total abdominal hysterectomy ( TAH ) at 5 years after surgery .


Randomised clinical trial with central , computer-generated randomisation .


Danish multi-centre trial performed in 11 departments of gynaecology .


Women referred with benign uterine diseases scheduled for abdominal hysterectomy .


Women were randomised to either SAH ( n = 161 ) or TAH ( n = 158 ) .


Follow-up data were collected from participants using postal questionnaires sent out 5 years after surgery .


Complications of hysterectomy were further examined by scrutinising registered discharge summaries following hospitalisation .


Intention-to-treat and per-protocol analyses were conducted .


Potential bias caused by missing data was handled using multiple imputation .


The primary outcome was UI .


Secondary outcomes included constipation , prolapse of the vaginal vault or cervical stump , satisfaction with sexual life , pelvic pain , postoperative complications and vaginal bleeding .


The response rate was 234/319 ( 73.4 % ) .


A significantly higher proportion of respondents had urinary incontinence 5 years after SAH 34/113 ( 30.1 % ) than TAH 21/119 ( 17.6 % ) ( RR 1.71 , 95 % confidence interval 1.06-2 .75 , P = 0.026 ) .


This difference reduced after multiple imputation to account for missing data ( RR 1.37 , 95 % confidence interval 0.99-1 .89 , P = 0.052 ) .


Eleven of the 101 women ( 11 % ) in the SAH group still experienced vaginal bleeding .


No other differences were found between the two types of abdominal hysterectomy .


A smaller proportion of women suffered from UI after TAH than after SAH 5 years postoperatively .


Around one in ten women continued to experience vaginal bleeding 5 years after SAH .


Two influenza B lineages have been co-circulating since the 1980s , and because inactivated trivalent influenza vaccine ( TIV ) contains only one B strain , it provides little/no protection against the alternate B-lineage .


We assessed a candidate inactivated quadrivalent influenza vaccine ( QIV ) containing both B lineages versus TIV in healthy adults .


Subjects received one dose of QIV ( lot 1 , 2 , or 3 ) or one of two TIVs ( B strain from Victoria or Yamagata lineage ) ; randomization was 2:2:2:1:1 .


Hemagglutination-inhibition assays were performed 21-days post-vaccination ; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95 % confidence interval ( CI ) lower limit for the GMT ratio was 1.5 , and non-inferiority against the shared strains was demonstrated if the 95 % CI upper limit for the GMT ratio was 1.5 .


Reactogenicity and safety were assessed during the post-vaccination period .


NCT01196975 .


Immunogenicity of QIV lots was consistent , QIV was superior to TIV for the alternate B-lineage strain , and QIV was non-inferior versus TIVs for shared strains ( A/H1N1 , A/H3N2 , B-strain ) .


Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines .


QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains , and without compromising safety .


The total enteroscopy rate of single-balloon enteroscopy ( SBE ) using air insufflation is not satisfactory , and whether carbon dioxide ( CO2 ) insufflation increases the total enteroscopy rate of SBE is unknown .


This randomised controlled trial aimed to determine whether CO2 insufflation facilitates the intubation depth and total enteroscopy rate of SBE .


A total of 214 eligible patients referred for SBE were randomised to receive either air or CO2 insufflation , and included in the intention-to-test ( ITT ) analysis .


In addition , 199 patients in whom enteroscopy was completed were included in the per-protocol ( PP ) analysis .


Both the patients and endoscopists were blinded , and the intubation depth and total enteroscopy rate were defined as the primary outcomes .


The CO2 group showed a superiority of intubation in the ITT analysis ( oral route : 323.864.2 vs 238.368.6 cm ; anal route : 261.674.2 vs 174.762.1 cm , both p < 0.001 ) , and the total enteroscopy rate ( 34.9 % vs 17.6 % , p = 0.006 ) .


Similar results were obtained in a PP analysis for both outcomes .


In addition , in the PP analysis , the addition of circumference after the procedure was less in the CO2 group ( 0.80.6 vs 3.31.8 cm , p = 0.005 ) for the oral route .


No serious complications were reported .


The overall percentage of procedures with significant pathological findings was 52.8 % ; the rates were 58.5 % and 47.2 % ( p = 0.100 , ITT analysis ) in the CO2 and air groups , respectively .


CO2 insufflation improves the intubation depth and total enteroscopy rate in SBE with a good safety profile and acceptability compared with that of air , and thus is recommended for clinical utilisation .


ClinicalTrial.gov identifier : NCT01758900 .


The authors evaluated the effect of an electronic personal health record on the quality of medical care in a community mental health setting .


A total of 170 individuals with a serious mental disorder and a comorbid medical condition treated in a community mental health center were randomly assigned to either a personal health record or usual care .


One-year outcomes assessed quality of medical care , patient activation , service use , and health-related quality of life .


Patients used the personal health record a mean of 42.1 times during the 1-year intervention period .


In the personal health record group , the total proportion of eligible preventive services received increased from 24 % at baseline to 40 % at the 12-month follow-up , whereas it declined in the usual care group , from 25 % to 18 % .


In the subset of patients with one or more cardiometabolic conditions ( N = 118 ) , the total proportion of eligible services received improved by 2 percentage points in the personal health record group and declined by 11 percentage points in the usual care group , resulting in a significant difference in change between the two groups .


There was an increase in the number of outpatient medical visits , which appeared to explain many of the significant differences in the quality of medical care .


Having a personal health record resulted in significantly improved quality of medical care and increased use of medical services among patients .


Personal health records could provide a relatively low-cost scalable strategy for improving medical care for patients with comorbid medical and serious mental illnesses .


Bioelectrical impedance analysis would be a more practical tool to measure body composition in clinical settings , dietetic practice and epidemiological studies if patients/subjects did not have to fast before measurements .


The present study assessed whether the ingestion of food or drink had any biologically significant effect on bioimpedance measurements and body composition by the foot-to-foot method .


Fifty-five healthy adults [ 30 males and 25 females ; mean ( SD ) age 27.7 ( 7.1 ) years ; mean ( SD ) body mass index 24 ( 3.8 ) kg m ( -2 ) ] were randomly assigned to a 2-day food trial ( high-fat meal or high-carbohydrate meal ) or a 2-day drink trial ( water or high electrolyte drink ) .


Body composition measurements were carried out in the fasting state , immediately after meal consumption and every 30 min for 2 h by the foot-to-foot single frequency bioimpedance technique .


Bioimpedance increased significantly after the ingestion of food and fluid , although the changes were small .


The electrolyte drink , high-fat and high-carbohydrate meals significantly increased the percentage body fat and fat mass .


In all cases , the median percentage changes from baseline were approximately 1 % in body fat percentage units .


Although there were statistically significant changes in body composition estimates after food or drink consumption , these were small and within the imprecision of the impedance technique , and so are unlikely to be of clinical significance .


The present study suggests that impedance measures of body fatness in clinical settings do not require strict adherence to fasting , and this should increase the opportunities for clinical application .


Hip fracture ( HF ) in frail elderly patients is associated with poor physical recovery and death .


There is often postoperative blood loss and the hemoglobin ( Hb ) threshold for red blood cell ( RBC ) transfusions in these patients is unknown .


We investigated whether RBC transfusion strategies were associated with the degree of physical recovery or with reduced mortality after HF surgery .


We enrolled 284 consecutive post-surgical HF patients ( aged 65 years ) with Hb levels < 11.3 g/dL ( 7 mmol/L ) who had been admitted from nursing homes or sheltered housing .


Allocation was stratified by residence .


The patients were randomly assigned to either restrictive ( Hb < 9.7 g/dL ; < 6 mmol/L ) or liberal ( Hb < 11.3 g/dL ; < 7 mmol/L ) RBC transfusions given within the first 30 days postoperatively .


Follow-up was at 90 days .


No statistically significant differences were found in repeated measures of daily living activities or in 90-day mortality rate between the restrictive group ( where 27 % died ) and the liberal group ( where 21 % died ) .


Per-protocol 30-day mortality was higher with the restrictive strategy ( hazard ratio ( HR ) = 2.4 , 95 % CI : 1.1-5 .2 ; p = 0.03 ) .


The 90-day mortality rate was higher for nursing home residents in the restrictive transfusion group ( 36 % ) than for those in the liberal group ( 20 % ) ( HR = 2.0 , 95 % CI : 1.1-3 .6 ; p = 0.01 ) .


According to our Hb thresholds , recovery from physical disabilities in frail elderly hip fracture patients was similar after a restrictive RBC transfusion strategy and after a liberal strategy .


Implementation of a liberal RBC transfusion strategy in nursing home residents has the potential to increase survival .


This prospective and randomized study was designed to compare safety , potential complications , and patient and examiner satisfaction of 2 anesthetic combinations - etomidate-remifentanil and propofol-remifentanil - in elderly patients undergoing diagnostic gastroscopy .


A group of 720 patients , aged 60-80 years , scheduled for diagnostic gastroscopy under sedation were prospectively randomized .


After 0.4-0 .6 g kg of remifentanil was infused , etomidate or propofol was administered .


Patients in the etomidate group received doses of etomidate at 0.1-0 .15 mg kg followed by 4-6 mg .


Patients in the propofol group received doses of propofol at 1-2 mg kg followed by 20-40 mg .


Physiological indexes were evaluated for the 715 of 720 patients that completed the treatment .


The onset time , duration time , and discharge time were recorded .


Physicians , anesthetists , and patients were surveyed to assess their satisfaction .


Systolic pressure and diastolic pressure decreased significantly after the procedure in the propofol group ( P < 0.001 ) .


The average heart rate was significantly lower in the propofol group ( P < 0.05 ) .


No periods of desaturation ( SpO < 95 % ) were observed in either group .


The onset time was earlier in the etomidate group ( P = 0.00 ) .


All adverse events , with the exception of myoclonus , were greater in the propofol group , and physician and patient satisfaction in both groups was similar .


Etomidate-remifentanil administration for sedation and analgesia during gastroscopy resulted in more stable hemodynamic responses and less adverse events in older patients .


Asynchronous e-learning allows for targeted teaching , particularly advantageous when bedside and didactic education is insufficient .


An asynchronous e-learning curriculum has not been studied across multiple centers in the context of a clinical rotation .


We hypothesize that an asynchronous e-learning curriculum during the pediatric emergency medicine ( EM ) rotation improves medical knowledge among residents and students across multiple participating centers .


Trainees on pediatric EM rotations at four large pediatric centers from 2012 to 2013 were randomized in a Solomon four-group design .