The pharmacodynamic effect of PT302 on the postprandial response of insulin and C-peptide was significant on days 21 to 28 at the 4-mg dose and was positively correlated with plasma exenatide concentrations , whereas the correlations with glucose and glucagon were not significant .


The fasting levels of these pharmacodynamic biomarkers were not altered by PT302 .


The most common adverse events were injection site induration and pruritus related to inflammatory foreign body reaction , which were mild and spontaneously resolved within several weeks .


The pharmacokinetic characteristics of PT302 were biphasic and dose proportional .


A single 4-mg dose of PT302 significantly increased the insulin and C-peptide response to oral glucose loading and was well tolerated in healthy individuals .


To compare the effects of short-term and long-term thromboprophylaxis after total hip replacement on coagulation indicators in plasma sampled before and 1 , 7 and 35 days post-operation .


A total of 40 patients scheduled for elective total hip replacement were randomly assigned into the short-term ( n = 20 ) or long-term ( n = 20 ) thromboprophylaxis groups on oral rivaroxaban 10 mg once daily for 7 or 35 days .


The primary efficacy hemostatic variables included thrombin-antithrombin complexes ( TAT ) , prothrombin fragment 1 +2 ( F1t2 ) , D-dimer and fibrinogen ( Fib ) preoperatively and at Days 1 , 7 and 35 postoperatively .


And ultrasonography was performed on all patients preoperatively and at days 7 and 35 postoperatively to exclude deep vein thrombosis of lower extremities .


None of them had deep vein thrombosis ( DVT ) of lower extremities .


Among them , TAT , F1 +2 , D-dimer and Fib post-operation were higher than those preoperative baseline values .


TAT and D-dimer peaked at day 1 postoperatively while the peaks of F1 +2 and Fib appeared at day 7 postoperatively .


At Day 35 post-operation , the levels of TAT and F1 +2 in the long-term thromboprophylaxis group were significantly lower than those of the short-term thromboprophylaxis group ( P < 0.05 ) .


The status of hypercoagulability may sustain at least 35 days after total hip replacement .


Though not completely eliminated , it can still be reduced by prolonged thromboprophylaxis .


However , according to ultrasonography , the effects of short-term and long-term thromboprophylaxis on the incidence rate of DVT remain to be further explored .


Using a multidimensional approach , we assessed young women 's knowledge of oral contraceptives ( OC ) and its influence on OC continuation rates .


We used data from 659 women aged 13-25 years participating in a randomized controlled trial of an educational text message OC continuation intervention .


Women received 6 months of daily text messages or routine care .


At baseline and 6 months , we administered a comprehensive 41-item questionnaire measuring knowledge of OC 's mechanism , effectiveness , use , side effects , risks , and benefits .


We ascertained OC continuation status and reasons for discontinuation at 6 months .


We analyzed relationships between OC knowledge and continuation with multivariable logistic regression .


Young women scored , on average , 22.8 out of 41 points on the OC knowledge assessment at baseline and 24.7 points at 6 months .


The 6-month OC continuation rate was 59 % .


OC continuers had > 2-points-higher OC knowledge scores at 6 months than discontinuers ( p < 0.001 ) .


Those who reported discontinuing their OCs for side effects and forgetfulness scored > 2 points lower than women who discontinued for other reasons ( p-values < 0.001 ) .


In multivariable regression models , each correct response on the baseline and 6-month knowledge assessments was associated with a 4 % and 6 % increased odds of OC continuation , respectively .


Six-month OC knowledge scores were negatively associated with OC discontinuation due to side effects ( odds ratio [ OR ] 0.94 ) and forgetfulness ( OR 0.88 ) .


OC knowledge , which was low among young women in our study , was associated with OC continuation and common reasons for discontinuation .


Continued efforts to characterize relationships between OC knowledge and behavior and to test the effectiveness of different components of interventions aimed at increasing knowledge , addressing side effects , and improving use of OCs are warranted .


Fabry disease is an X-linked lysosomal storage disorder affecting both males and females with tremendous genotypic/phenotypic variability .


Concentrations of globotriaosylceramide ( Gb3 ) , globotriaosylsphingosine ( lyso-Gb3 ) / related analogues were investigated in pediatric and adult Fabry cohorts .


The aims of this study were to transfer and validate an HPLC-MS/MS methodology on a UPLC-MS/MS new generation platform , using an HPLC column , for urine analysis of treated and untreated pediatric and adult Fabry patients , to establish correlations between the excretion of Fabry biomarkers with gender , treatment , types of mutations , and to evaluate the biomarker reliability for early detection of pediatric Fabry patients .


A UPLC-MS/MS was used for biomarker analysis .


Reference values are presented for all biomarkers .


Results show that gender strongly influences the excretion of each biomarker in the pediatric Fabry cohort , with females having lower urinary levels of all biomarkers .


Urinary distribution of lyso-Gb3 / related analogues in treated Fabry males was similar to the untreated and treated Fabry female groups in both children and adult cohorts .


Children with the late-onset p.N215S mutation had normal urinary levels of Gb3 , and lyso-Gb3 but abnormal levels of related analogues .


In this study , Fabry males and most Fabry females would have been diagnosed using the urinary lyso-Gb3 / related analogue profile .


Binge drinking is responsible for over half of all alcohol-related deaths and results in significant health and economic costs to individuals and society .


Knowledge of genetic aspects of this behavior , particularly as it emerges in young adulthood , could lead to improved treatment and prevention programs .


We have focused on the association of variation in neuronal nicotinic receptor subunit genes ( CHRNs ) in a cohort of 702 Hispanic and non-Hispanic White young adults who are part of the Social and Emotional Contexts of Adolescent Smoking Patterns ( SECASP ) study .


Fifty-five single nucleotide polymorphisms ( SNPs ) covering the variation in 5 CHRNs ( CHRNA4 , CHRNB2 , CHRNA2 , CHRNB3A6 , and CHRNA5A3B4 ) were studied .


Frequency of binge drinking and other correlated alcohol consumption measures were significantly associated with SNPs in CHRNA4 ( p-values ranged from 0.0003 to 0.02 ) , but not with SNPs in other CHRNs .


This association was independent of smoking status in our cohort .


Variants in CHRNA4 may contribute to risk of binge drinking in young adults in this cohort .


Results will need to be confirmed in independent samples .


Informal caregivers ( family and friends ) of people with cancer are often unprepared for their caregiving role , leading to increased burden or distress .


Comprehensive Health Enhancement Support System ( CHESS ) is a Web-based lung cancer information , communication , and coaching system for caregivers .


This randomized trial reports the impact on caregiver burden , disruptiveness , and mood of providing caregivers access to CHESS versus the Internet with a list of recommended lung cancer websites .


A total of 285 informal caregivers of patients with advanced nonsmall cell lung cancer were randomly assigned to a comparison group that received Internet or a treatment group that received Internet and CHESS .


Caregivers were provided a computer and Internet service if needed .


Written surveys were completed at pretest and during the intervention period bimonthly for up to 24 months .


Analyses of covariance ( ANCOVAs ) compared the intervention 's effect on caregivers ' disruptiveness and burden ( CQOLI-C ) , and negative mood ( combined Anxiety , Depression , and Anger scales of the POMS ) at 6 months , controlling for blocking variables ( site , caregiver 's race , and relationship to patient ) and the given outcome at pretest .


Caregivers randomized to CHESS reported lower burden , t ( 84 ) = 2.36 , p = .021 , d = .39 , and negative mood , t ( 86 ) = 2.82 , p = .006 , d = .44 , than those in the Internet group .


The effect on disruptiveness was not significant .


Although caring for someone with a terminal illness will always exact a toll on caregivers , eHealth interventions like CHESS may improve caregivers ' understanding and coping skills and , as a result , ease their burden and mood .


Krill is an increasingly popular source of marine n-3 ( -3 ) PUFA that is seen as a premium product .


However , to our knowledge , the effect of krill-oil supplementation on insulin sensitivity in humans has not been reported .


We assessed whether supplementation with a blend of krill and salmon ( KS ) oil [ which is rich in eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) ] affects insulin sensitivity in overweight men .


The design was a randomized , double-blind , controlled crossover trial .


A total of 47 men with a mean SD age of 46.5 5.1 y , who were overweight [ body mass index ( in kg/m ( 2 ) ) from 25 to 30 ] but otherwise healthy , received 5 1-g capsules of KS oil or a control ( canola oil ) for 8 wk and crossed over to another treatment after an 8-wk washout period .


The primary outcome was insulin sensitivity assessed by using the Matsuda method from an oral-glucose-tolerance test .


Secondary outcomes included lipid profiles , inflammatory markers , 24-h ambulatory blood pressure , and carotid artery intimamedia thickness .


Unexpectedly , insulin sensitivity ( per the Matsuda index ) was 14 % lower with the KS oil than with the control oil ( P = 0.049 ) .


A mediation analysis showed that , after controlling for the likely positive effects of blood EPA and DHA ( i.e. , the omega-3 index ) , the reduction in insulin sensitivity after KS-oil supplementation was more marked [ 27 % lower than with the control oil ( P = 0.009 ) ] .


Supplementation with a blend of KS oil is associated with decreased insulin sensitivity .


Thus , krill-oil supplementation in overweight adults could exacerbate risk of diabetes and cardiovascular disease .


This trial was prospectively registered at the Australian New Zealand Clinical Trials Registry as ACTRN12611000602921 .


To observe the clinical efficacy of Tongfu Mixture ( TM ) for post-ERCP pancreatitis ( PEP ) .


Totally 54 PEP patients were randomly assigned to the control group ( treated by routine therapy , 26 cases ) and the TM treatment group ( treated by TM , 28 cases ) .


Clinical indices including the alleviation time of abdominal pain/distention , gastrointestinal function recovery time , and the post-surgical length of stay were observed .


Blood amylase ( AMY ) , C-reactive protein ( CRP ) , plasma endotoxin ( PLS ) , TNF-alpha , and IL-6 were detected before surgery , 12 h , 48 h , and 96 h after surgery .


The alleviation time of abdominal pain/distention , the gastrointestinal function recovery time , and the post-surgical length of stay were obviously shorter in the TM treatment group than those in the control group ( P < 0.05 ) .


The recovery of AMY and CRP were better in the TM treatment group than in the control group at post-operative 48 h and 96 h ( P < 0.05 ) .


The levels of LPS , TNF-alpha , and IL-6 were lower in the TM group than in the control group at post-operative 96 h ( P < 0.05 ) .


TM showed better clinical efficacy and could significantly decrease the post-surgical length of stay .


post-ERCP pancreatitis ; integrative medicine ; Tongfu Mixture


Preventive health checks may identify individuals with an unhealthy lifestyle and motivate them to change behaviour .


However , knowledge about the impact of the different components included in preventive health checks is deficient .


The aim of this trial is to evaluate whether including cardiorespiratory fitness testing in preventive health checks 1 ) increases cardiorespiratory fitness level and motivation to change physical activity behaviour and 2 ) reduces physical inactivity prevalence and improves self-rated health compared with preventive health checks without fitness testing .


An open-label , household-cluster , randomized controlled trial with a two-group parallel design is used .


The trial is embedded in a population-based health promotion program , `` Check your Health Preventive Program '' , in which all 30-49 year-old citizens in a Danish municipality are offered a preventive health check .


In each arm of the trial , 750 citizens will be recruited ( 1,500 in total ) .


The primary outcome is cardiorespiratory fitness level assessed by submaximal cycle ergometer testing after one year .


An intermediate outcome is the percentage of participants increasing motivation for physical activity behaviour change between baseline and two-weeks follow-up assessed using the Transtheoretical Model 's stages of change .


Secondary outcomes include changes from baseline to one-year follow-up in physical inactivity prevalence measured by a modified version of the questions developed by Saltin and Grimby , and in self-rated health measures using the Short-Form 12 , Health Survey , version 2 .


This trial will contribute to a critical appraisal of the value of fitness testing as part of preventive health checks .


The conduction in real-life community and general practice structures makes the trial findings applicable and transferable to other municipalities providing support to decision-makers in the development of approaches to increase levels of physical activity and improve health .


ClinicalTrials.gov Identifier : NCT02224248 .


Registered 8 August 2014 .


Patients who are critically ill can develop so-called intensive-care unit acquired weakness , which delays rehabilitation .


Reduced muscle mass , quality , or both might have a role .


The Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients ( EPaNIC ) trial ( registered with ClinicalTrials.gov , number NCT00512122 ) showed that tolerating macronutrient deficit for 1 week in intensive-care units ( late parenteral nutrition [ PN ] ) accelerated recovery compared with early PN .


The role of weakness was unclear .


Our aim was to assess whether late PN and early PN differentially affect muscle weakness and autophagic quality control of myofibres .


In this prospectively planned subanalysis of the EPaNIC trial , weakness ( MRC sum score ) was assessed in 600 awake , cooperative patients .


Skeletal muscle biopsies , harvested from 122 patients 8 days after randomisation and from 20 matched healthy controls , were studied for autophagy and atrophy .


We determined the significance of differences with Mann-Whitney U , Median , Kruskal-Wallis , or ( 2 ) ( exact ) tests , as appropriate .


With late PN , 105 ( 34 % ) of 305 patients had weakness on first assessment ( median day 9 post-randomisation ) compared with 127 ( 43 % ) of 295 patients given early PN ( absolute difference -9 % , 95 % CI -16 to -1 ; p = 0030 ) .


Weakness recovered faster with late PN than with early PN ( p = 0021 ) .


Myofibre cross-sectional area was less and density was lower in critically ill patients than in healthy controls , similarly with early PN and late PN .


The LC3 ( microtubule-associated protein light chain 3 ) II to LC3I ratio , related to autophagosome formation , was higher in patients given late PN than early PN ( p = 0026 ) , reaching values almost double those in the healthy control group ( p = 00016 ) , and coinciding with less ubiquitin staining ( p = 0019 ) .


A higher LC3II to LC3I ratio was independently associated with less weakness ( p = 0047 ) .


Expression of mRNA encoding contractile myofibrillary proteins was lower and E3-ligase expression higher in muscle biopsies from patients than in control participants ( p00006 ) , but was unaffected by nutrition .


Tolerating a substantial macronutrient deficit early during critical illness did not affect muscle wasting , but allowed more efficient activation of autophagic quality control of myofibres and reduced weakness .


UZ Leuven , Research Foundation-Flanders , the Flemish Government , and the European Research Council .


SH2-containing inositol-5 ' - phosphatase 1 ( SHIP1 ) is an endogenous inhibitor of the phosphoinositide-3-kinase pathway that is involved in the activation and chemotaxis of inflammatory cells .


AQX-1125 is a first-in-class , oral SHIP1 activator with a novel anti-inflammatory mode of action .


To evaluate the effects of AQX-1125 on airway responses to allergen challenge in mild-to-moderate asthmatic patients .


A randomized , double-blind , placebo-controlled , two-way crossover study was performed in 22 steroid-nave mild-to-moderate asthmatics with a documented late-phase response to inhaled allergen ( LAR ) .


AQX-1125 ( 450 mg daily ) or placebo was administered orally for 7 days .


Allergen challenge was performed on day 6 ( 2 h postdose ) , followed by methacholine challenge ( day 7 ) , and induced sputum collection and fractional exhaled nitric oxide ( FeNO ) .


AQX-1125 significantly attenuated the late-phase response compared with placebo ( FEV1 4-10 h : mean difference 150 mL , 20 % ; P = 0.027 ) and significantly increased the minimum FEV1 during LAR ( mean difference 180 mL ; P = 0.014 ) .


AQX-1125 had no effect on the early-phase response .


AQX-1125 showed a trend in reduction of sputum eosinophils , neutrophils and macrophages although this did not achieve significance as there were only 11 paired samples for analysis .


There was no effect on methacholine responsiveness or FeNO .


Pharmacokinetic data showed AQX-1125 was rapidly absorbed with geometric mean Cmax and AUC0-24 h values of 1417 ng/mL and 16 727 h ng/mL , respectively .


AQX-1125 was well tolerated , but mild GI side-effects ( dyspepsia , nausea and abdominal pain ) were described in 4/22 subjects on active treatment .


These side-effects were mild self-limiting , required no further treatment and did not lead to discontinuation of therapy .


AQX-1125 , a novel oral SHIP1 activator , significantly reduces the late response to allergen challenge , with a trend to reduce airway inflammation .


AQX-1125 was safe and well tolerated and merits further investigation in inflammatory disorders .


Endoscopic submucosal dissection ( ESD ) allows en bloc resection of superficial colorectal tumors regardless of size .


However , ESD is technically difficult , hazardous , and time consuming .


New devices may help overcome these drawbacks .


We focused on traction methods and designed a new traction device , the `` S-O clip . ''


Its main advantage is that it allows direct visualization of the cutting line during submucosal dissection .


Moreover , it can be used at any location without withdrawing the endoscope .


The purpose of this study was to evaluate the efficacy and safety of traction device-assisted ESD for large colorectal tumors using the S-O clip .


Between August 2010 and December 2011 , ESD was performed in 70 patients with a superficial colorectal tumor 20 mm in diameter in our department .


Patients were randomized into two groups : 27 cases in the S-O clip-assisted ESD group and 23 cases in the conventional ESD group .


Included in the analysis were patient 's gender and age , tumor form , size , and location , rate of en bloc resection , procedure time , presence or absence of intraoperative perforation or delayed bleeding , and pathological findings .


Subgroup analysis stratified by these factors and multivariate analyses were conducted .


In the S-O clip-assisted ESD group , all 27 tumors were resected en bloc without any complications .


Although a micro perforation occurred in one patient in the conventional ESD group , further surgical treatment was not required .


None of the other 22 cases in the conventional ESD group experienced complications .


The mean procedure time for the S-O clip-assisted ESD group was significantly shorter than for the conventional ESD group ( 37.4 32.6 vs. 67.1 44.1 min , p = 0.03 ) .


No significant between-group differences were found for the other factors .


Our results demonstrated that S-O clip-assisted ESD is safe and fast for en bloc resection of large superficial colorectal tumors .


A mosquito repellent has the potential to prevent malaria infection , but there has been few studies demonstrating the effectiveness of combining this strategy with the highly effective long-lasting insecticidal nets ( LLINs ) .


This study aimed to determine the effect of combining community-based mosquito repellent with LLINs in the reduction of malaria .


A community-based clustered-randomised trial was conducted in 16 rural villages with 1,235 households in southern Ethiopia between September and December of 2008 .


The villages were randomly assigned to intervention ( mosquito repellent and LLINs , eight villages ) and control ( LLINs alone , eight villages ) groups .


Households in the intervention villages received mosquito repellent ( i.e. , Buzz-Off petroleum jelly , essential oil blend ) applied every evening .


The baseline survey was followed by two follow-up surveys , at one month interval .


The primary outcome was detection of Plasmodium falciparum , Plasmodium vivax , or both parasites , through microscopic examination of blood slides .


Analysis was by intention to treat .


Baseline imbalances and clustering at individual , household and village levels were adjusted using a generalized linear mixed model .


3,078 individuals in intervention and 3,004 in control group were enrolled into the study .


Compared with the control arm , the combined use of mosquito repellent and LLINs significantly reduced malaria infection of all types over time [ adjusted Odds Ratio ( aOR ) = 0.66 ; 95 % CI = 0.45-0 .97 ] .


Similarly , a substantial reduction in P. falciparum malaria infection during the follow-up surveys was observed in the intervention group ( aOR = 0.53 , 95 % CI = 0.31-0 .89 ) .


The protective efficacy of using mosquito repellent and LLINs against malaria infection of both P. falciparum/P .


vivax and P. falciparum was 34 % and 47 % , respectively .


Daily application of mosquito repellent during the evening followed by the use of LLINs during bedtime at community level has significantly reduced malaria infection .


The finding has strong implication particularly in areas where malaria vectors feed mainly in the evening before bedtime .


ClinicalTrials.gov identifier : NCT01160809 .


Most patients with acute myeloid leukemia ( AML ) eventually experience relapse .


Relapsed/refractory AML has a dismal prognosis and currently available treatment options are generally ineffective .


The objective of this large , international , randomized clinical trial was to investigate the efficacy of elacytarabine , a novel elaidic acid ester of cytarabine , versus the investigator 's choice of one of seven commonly used AML salvage regimens , including high-dose cytarabine , multiagent chemotherapy , hypomethylating agents , hydroxyurea , and supportive care .


A total of 381 patients with relapsed/refractory AML were treated in North America , Europe , and Australia .


Investigators selected a control treatment for individual patients before random assignment .


The primary end point was overall survival ( OS ) .


There were no significant differences in OS ( 3.5 v 3.3 months ) , response rate ( 23 % v 21 % ) , or relapse-free survival ( 5.1 v 3.7 months ) between the elacytarabine and control arms , respectively .


There was no significant difference in OS among any of the investigator 's choice regimens .


Prolonged survival was only achieved in a few patients in both study arms whose disease responded and who underwent allogeneic stem-cell transplantation .


Neither elacytarabine nor any of the seven alternative treatment regimens provided clinically meaningful benefit to these patients .


OS in both study arms and for all treatments was extremely poor .


Novel agents , novel clinical trial designs , and novel strategies of drug development are all desperately needed for this patient population .


Modifiable vascular and lifestyle-related risk factors have been associated with dementia risk in observational studies .


In the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability ( FINGER ) , a proof-of-concept randomised controlled trial , we aimed to assess a multidomain approach to prevent cognitive decline in at-risk elderly people from the general population .


In a double-blind randomised controlled trial we enrolled individuals aged 60-77 years recruited from previous national surveys .


Inclusion criteria were CAIDE ( Cardiovascular Risk Factors , Aging and Dementia ) Dementia Risk Score of at least 6 points and cognition at mean level or slightly lower than expected for age .


We randomly assigned participants in a 1:1 ratio to a 2 year multidomain intervention ( diet , exercise , cognitive training , vascular risk monitoring ) , or a control group ( general health advice ) .


Computer-generated allocation was done in blocks of four ( two individuals randomly allocated to each group ) at each site .


Group allocation was not actively disclosed to participants and outcome assessors were masked to group allocation .


The primary outcome was change in cognition as measured through comprehensive neuropsychological test battery ( NTB ) Z score .


Analysis was by modified intention to treat ( all participants with at least one post-baseline observation ) .


This trial is registered at ClinicalTrials.gov , number NCT01041989 .


Between Sept 7 , 2009 , and Nov 24 , 2011 , we screened 2654 individuals and randomly assigned 1260 to the intervention group ( n = 631 ) or control group ( n = 629 ) .


591 ( 94 % ) participants in the intervention group and 599 ( 95 % ) in the control group had at least one post-baseline assessment and were included in the modified intention-to-treat analysis .


Estimated mean change in NTB total Z score at 2 years was 020 ( SE 002 , SD 051 ) in the intervention group and 016 ( 001 , 051 ) in the control group .


Between-group difference in the change of NTB total score per year was 0022 ( 95 % CI 0002-0042 , p = 0030 ) .


153 ( 12 % ) individuals dropped out overall .


Adverse events occurred in 46 ( 7 % ) participants in the intervention group compared with six ( 1 % ) participants in the control group ; the most common adverse event was musculoskeletal pain ( 32 [ 5 % ] individuals for intervention vs no individuals for control ) .


Findings from this large , long-term , randomised controlled trial suggest that a multidomain intervention could improve or maintain cognitive functioning in at-risk elderly people from the general population .


Academy of Finland , La Carita Foundation , Alzheimer Association , Alzheimer 's Research and Prevention Foundation , Juho Vainio Foundation , Novo Nordisk Foundation , Finnish Social Insurance Institution , Ministry of Education and Culture , Salama bint Hamdan Al Nahyan Foundation , Axa Research Fund , EVO funding for University Hospitals of Kuopio , Oulu , and Turku and for Seinjoki Central Hospital and Oulu City Hospital , Swedish Research Council , Swedish Research Council for Health , Working Life and Welfare , and af Jochnick Foundation .


The central nervous system manifestations in Fabry disease ( FD ) include progressive white matter lesions ( WMLs ) and stroke .


Due to progressive microvascular involvement , men and women with FD over 35 years of age develop WMLs .


Moreover , the prevalence of stroke has been estimated to be 12 times higher in FD compared with the general population .


Enzyme replacement therapy ( ERT ) is available and has shown beneficial effects on renal , cardiac , and peripheral nerve function in FD , but the ERT effect on the progression of WMLs , or the reduction in cerebrovascular events , remains unknown .


The WML burden and the effect of agalsidase beta 1 mg/kg biweekly on WML progression were assessed longitudinally in a Phase 4 agalsidase-beta placebo-controlled analysis of untreated and treated FD patients with mild-to-moderate renal involvement ( serum creatinine measurements of 1.2 mg/dl and < 3.0 mg/dl ) .


The primary end point was the difference in the number of patients with increased WML burden between the agalsidase beta and placebo groups at the end of treatment .


The diameters of the WMLs were determined manually using axial flow-attenuated-inversion-recovery-weighted magnetic resonance imaging ( MRI ) scans taken at baseline and follow-up .


MRI scans from 41 FD patients ( mean age 43.9 , age range 20-68 , 3 females ; n = 25 on ERT , n = 16 on placebo ) were analyzed .


WML burden was present in 63 % of patients at baseline , increased over a mean of 27 months ( range 12-33 months ) follow-up , and correlated with left ventricular hypertrophy ( LVPW ) .


Patients with previous or recent strokes ( n = 11 , 39-68 years ) showed an increase in the number of WMLs ( p = 0.005 ) .


A greater proportion of younger patients ( 50 years ) on ERT ( n = 18 ) had stable WML burden compared with younger patients in the placebo group ( n = 13 ) : 44 % ( 8 of 18 ) versus 31 % ( 4 of 13 ) , p = 0.014 .


The number needed to treat was 8 .


This FD patient cohort , with mild-to-moderate renal involvement , had a significant WML burden and high inter-individual variability associated with the degree of LVPW but not the degree of kidney dysfunction .


These advanced patients with increased LVPW and stroke evidence may have had a higher cerebrovascular risk .


The WML burden in patients on ERT was more likely to remain stable , compared with patients on placebo .


Thus , ERT may reduce the progression of vascular disease , even in advanced FD patients , suggesting that early treatment may stabilize WML progression and stroke risk .


The extent to which alterations in energy expenditure ( EE ) in response to sleep restriction contribute to the short sleep-obesity relationship is not clearly defined .


Short sleep may induce changes in resting metabolic rate ( RMR ) , thermic effect of food ( TEF ) and postprandial substrate oxidation .


Ten females ( age and body mass index : 22-43 years and 23.4-28kgm ( -2 ) ) completed a randomized , crossover study assessing the effects of short ( 4h per night ) and habitual ( 8h per night ) sleep duration on fasting and postprandial RMR and respiratory quotient ( RQ ) .


Measurements were taken after three nights using whole-room indirect calorimetry .


The TEF was assessed over a 6-h period following consumption of a high-fat liquid meal .


Short versus habitual sleep did not affect RMR ( 1.010.05 and 0.970.04 kcalmin ( -1 ) ; P = 0.23 ) .


Fasting RQ was significantly lower after short versus habitual sleep ( 0.840.01 and 0.880.01 ; P = 0.028 ) .


Postprandial EE ( short : 1.130.04 and habitual : 1.100.04 , P = 0.09 ) and RQ ( short : 0.880.01 and habitual : 0.880.01 , P = 0.50 ) after the high-fat meal were not different between conditions .


TEF was similar between conditions ( 0.240.02 kcalmin ( -1 ) in both ; P = 0.98 ) , as was the ~ 6-h incremental area under the curve ( 1.160.10 and 1.170.09 kcalmin ( -1 ) 356min after short and habitual sleep , respectively ; P = 0.92 ) .


Current findings observed in non-obese healthy premenopausal women do not support the hypothesis that alterations in TEF and postprandial substrate oxidation are major contributors to the higher rate of obesity observed in short sleepers .


In exploring a role of sleep duration on EE , research should focus on potential alterations in physical activity to explain the increased obesity risk in short sleepers .


One form of meditation intervention , the integrative body-mind training ( IBMT ) has been shown to improve attention , reduce stress and change self-reports of mood .


In this paper we examine whether short-term IBMT can improve performance related to creativity and determine the role that mood may play in such improvement .


Forty Chinese undergraduates were randomly assigned to short-term IBMT group or a relaxation training ( RT ) control group .


Mood and creativity performance were assessed by the Positive and Negative Affect Schedule ( PANAS ) and Torrance Tests of Creative Thinking ( TTCT ) questionnaire respectively .


As predicted , the results indicated that short-term ( 30 min per day for 7 days ) IBMT improved creativity performance on the divergent thinking task , and yielded better emotional regulation than RT. .


In addition , cross-lagged analysis indicated that both positive and negative affect may influence creativity in IBMT group ( not RT group ) .


Our results suggested that emotion-related creativity-promoting mechanism may be attributed to short-term meditation .


Randomized clinical trial .


To determine the effects of trigger point dry needling ( TrPDN ) on neck pain , widespread pressure pain sensitivity , and cervical range of motion in patients with acute mechanical neck pain and active trigger points in the upper trapezius muscle .


TrPDN seems to be effective for decreasing pain in individuals with upper-quadrant pain syndromes .


Potential effects of TrPDN for decreasing pain and sensitization in individuals with acute mechanical neck pain are needed .


Methods Seventeen patients ( 53 % female ) were randomly assigned to 1 of 2 groups : a single session of TrPDN or no intervention ( waiting list ) .


Pressure pain thresholds over the C5-6 zygapophyseal joint , second metacarpal , and tibialis anterior muscle ; neck pain intensity ; and cervical spine range-of-motion data were collected at baseline ( pretreatment ) and 10 minutes and 1 week after the intervention by an assessor blinded to the treatment allocation of the patient .


Mixed-model analyses of variance were used to examine the effects of treatment on each outcome variable .


Patients treated with 1 session of TrPDN experienced greater decreases in neck pain , greater increases in pressure pain threshold , and higher increases in cervical range of motion than those who did not receive an intervention at both 10 minutes and 1 week after the intervention ( P < .01 for all comparisons ) .


Between-group effect sizes were medium to large immediately after the TrPDN session ( standardized mean score differences greater than 0.56 ) and large at the 1-week follow-up ( standardized mean score differences greater than 1.34 ) .


The results of the current randomized clinical trial suggest that a single session of TrPDN may decrease neck pain intensity and widespread pressure pain sensitivity , and also increase active cervical range of motion , in patients with acute mechanical neck pain .


Changes in pain , pressure pain threshold , and cervical range of motion surpassed their respective minimal detectable change values , supporting clinically relevant treatment effects .


Level of Evidence Therapy , level 1b - .


To evaluate the applicability of single-incision laparoscopic ovariectomy ( SILOVE ) in cats using a single-incision laparoscopic port ( SILP ) ; to compare surgical time , complications , and postoperative pain after SILOVE using a LigaSure ( SILOVE-LS ) or extracorporeal suture ( SILOVE-ECS ) , and open ovariectomy ( open-OVE ) .


Randomized , blinded , prospective study .


Healthy , domestic female cats ( n = 24 ) .


Cats underwent physical examination , packed cell volume , total solids and blood urea nitrogen analysis .


Cats were randomly assigned to 1 of 3 groups : SILOVE-LS ( n = 8 ) , SILOVE-ECS ( 8 ) or open-OVE ( 8 ) .


Surgical time , complications , and postoperative pain scores were recorded .


Single-incision laparoscopic ovariectomy was successful in ( n = 8 ) SILOVE-LS cats and ( n = 5 ) SILOVE-ECS cats .


Surgical time was significantly longer for the SILOVE-ECS group compared with the SILOVE-LS ( P < .0001 ) and open-OVE ( P < .0001 ) groups , which were not different ( P = .55 ) .


Complications were more frequent in the SILOVE-ECS group and removal of the SILP was required to complete ovariectomy in 3 cats .


Cumulative 4-hour pain scores were not different between groups .


Single-incision laparoscopic ovariectomy using a SILP is a feasible method for OVE in cats .


Single-incision laparoscopic ovariectomy using an extracorporeal suture is more time consuming and associated with more complications than either the SILOVE-LS or open-OVE methods .


Indacaterol/glycopyrronium ( IND/GLY ) is a once-daily inhaled fixed-dose combination of indacaterol ( IND ) , a long-acting 2-adrenergic agonist ( LABA ) , and glycopyrronium ( GLY ) , a long-acting muscarinic antagonist ( LAMA ) for use as maintenance treatment to relieve symptoms of chronic obstructive pulmonary disease ( COPD ) in adults .


To determine the economic benefits of IND/GLY compared with the free combination of indacaterol and glycopyrronium ( IND+GLY ) , and with the fixed-dose combination of salmeterol/fluticasone ( SFC ) , in a moderate-to-severe COPD population with low-exacerbation risk .


The model-based analysis extrapolated results up to lifetime time horizon and calculated costs per quality-adjusted life year .


Assuming equal efficacy , a cost-minimisation analysis compared IND/GLY vs IND+GLY using model inputs from the double-blind , randomised SHINE trial .


The double-blind , randomised ILLUMINATE and TORCH trials were used to analyse cost-effectiveness versus SFC. To consider ICS-related pneumonia events , published odds ratio comparing an ICS-exposed group to a control group of COPD patients was used .


Direct and indirect drug costs as well as drug acquisition costs ( in Swedish Krona [ SEK ] ) were derived from published Swedish sources .


Cost and effects were discounted with 3 % .


Uncertainty was assessed by one-way and probabilistic sensitivity analyses ( PSA ) .


IND/GLY was cost-saving vs IND+GLY with incremental savings of SEK ( EUR ) 768 ( 85 ) , and 3309 ( 368 ) per patient over one and five years .


IND/GLY was found to be less costly and more effective compared to SFC with cost savings of SEK ( EUR ) 2744 ( 303 ) , 8854 ( 976 ) , 13,938 ( 1536 ) , 27,495 ( 3031 ) and 43,033 ( 4744 ) over one , three , five , ten years and lifetime .


The PSA indicated that all iterations produced dominant results for IND/GLY .


IND/GLY is cost-minimising vs IND+GLY and dominates SFC in the maintenance treatment of COPD patients in Sweden .


Encouraging dual bronchodilator therapy over an ICS-containing combination results in lower total costs and better outcomes compared to combination therapy including fluticasone in moderate-to-severe COPD patients with low exacerbation risk .


Although the combination of midazolam-meperidine has been widely used as a sedation regimen for colonoscopy , its residual effect which is longer than the duration of a colonoscopy procedure can delay patient recovery and discharge .


Remifentanil , an ultra-short-acting opioid , has a very brief duration of action .


We hypothesized that using remifentanil alone for colonoscopy would provide shorter recovery time compared with the midazolam-meperidine combination .


Time to achieve Aldrete score = 10 was determined and compared in patients who were randomly allocated to receive remifentanil alone ( group-R , n = 27 ) or a midazolam-meperidine combination ( group-MM , n = 27 ) for colonoscopy .


Intergroup differences in sedation , recall analgesia , cardio-respiratory profiles , and satisfaction of patient and endoscopist were also determined during and after colonoscopy .


Group-R showed a significantly shorter recovery time than group-MM ( median [ 25-75 % ] , 0 [ 0-10 ] vs 30 [ 15-30 ] min , P < 0.001 ) .


Group-R showed significantly higher bispectral-index values during colonoscopy ( 92 [ 85-96 ] vs 84 [ 80-87 ] , P = 0.001 ) ; a higher incidence of recall of explanations given during and after colonoscopy ( 100 vs 48 % and 96 vs 52 % , both P < 0.001 ) ; and a lower distress score ( visual analog scale 30/100 vs 37/100mm , P = 0.002 ) , than did group-MM .


Neither extent of pain , incidence of hemodynamic instability nor incidence of respiratory depression differed between the groups .


Remifentanil for colonoscopy afforded faster recovery compared to midazolam-meperidine combination .


It also provided greater patient-endoscopist communication and satisfaction with comparable patient analgesia and cardiorespiratory profile during colonoscopy .


To define the role of increased fundus autofluorescence ( FAF ) , a surrogate for lipofuscin content , as a risk factor for progression of geographic atrophy ( GA ) .


Prospective natural history cohort study , the GAIN ( Characterization of geographic atrophy progression in patients with age-related macular degeneration ) .


setting : Single-center study conducted in Barcelona , Spain .


After screening of 211 patients , 109 eyes of 82 patients with GA secondary to age-related macular degeneration and a minimum follow-up of 6 months were included .


Lipofuscin content was classified independently by 2 masked observers according to FAF patterns described previously .


Bivariate , stratified , and multivariable analyses were used to explore the associations between GA growth and independent variables .


Mediation analysis was used to evaluate the contribution of FAF patterns to GA progression .


Progression of GA in mm ( 2 ) / year as measured with FAF .


Median follow-up was 18 months ( range , 6-42 ) .


Median GA growth was 1.61 mm ( 2 ) / year .


FAF , baseline area of atrophy , and time of follow-up were independently associated with GA progression ( P < .004 ) .


FAF patterns and baseline area of atrophy were strongly associated ( P < .0001 ) , suggesting potential confounding .


Mediation analysis suggested that most of the effect of FAF patterns on GA growth was actually caused by baseline area of atrophy .


FAF patterns , baseline area of atrophy , and time of follow-up were associated with GA progression .


However , FAF patterns seem to be a consequence ( not a cause ) of enlarging atrophy and their effect on GA progression seems mostly driven by baseline area of atrophy .


Magnetic resonance imaging guided biopsy is increasingly performed to diagnose prostate cancer .


However , there is a lack of well controlled , prospective trials to support this treatment method .


We prospectively compared magnetic resonance imaging guided in-bore biopsy with standard systematic transrectal ultrasound guided biopsy in biopsy nave men with increased prostate specific antigen .


We performed a prospective study in 132 biopsy nave men with increased prostate specific antigen ( greater than 4 ng/ml ) .


After 3 Tesla functional multiparametric magnetic resonance imaging patients were referred for magnetic resonance imaging guided in-bore biopsy of prostate lesions ( maximum 3 ) followed by standard systematic transrectal ultrasound guided biopsy ( 12 cores ) .


We analyzed the detection rates of prostate cancer and significant prostate cancer ( greater than 5 mm total cancer length or any Gleason pattern greater than 3 ) .


A total of 128 patients with a mean SD age of 66.1 8.1 years metall study requirements .


Median prostate specific antigen was 6.7 ng/ml ( IQR 5.1-9 .0 ) .


Transrectal ultrasound and magnetic resonance imaging guided biopsies provided the same 53.1 % detection rate , including 79.4 % and 85.3 % , respectively , for significant prostate cancer .


Magnetic resonance imaging and transrectal ultrasound guided biopsies missed 7.8 % and 9.4 % of clinically significant prostate cancers , respectively .


Magnetic resonance imaging biopsy required significantly fewer cores and revealed a higher percent of cancer involvement per biopsy core ( each p < 0.01 ) .


Combining the 2 methods provided a 60.9 % detection rate with an 82.1 % rate for significant prostate cancer .


Magnetic resonance imaging guided in-bore and systematic transrectal ultrasound guided biopsies achieved equally high detection rates inbiopsy nave patients with increased prostate specific antigen .


Magnetic resonance imaging guided in-bore biopsies required significantly fewer cores and revealed a significantly higher percent of cancer involvement per biopsy core .


Ulcerative colitis ( UC ) is a chronic inflammatory bowel disease .


The probiotic bacterium Escherichia coli Nissle 1917 ( EcN ) has been used to maintain and induce clinical remission in UC .


Our aim was to test the effect of Ciprofloxacin and/or orally administered EcN as add-on to conventional therapies in patients with active UC .


Our single center double-blinded randomized placebo controlled study included patients with a Colitis Activity Index ( CAI ) score of at least 6 .


Patients were randomized to Ciprofloxacin or placebo for 1week followed by EcN or placebo for 7weeks .


All 4 treatments were given as add-on treatments .


One hundred subjects with active UC were recruited .


In the per-protocol analysis we , surprisingly , found that in the group receiving placebo/EcN fewer patients , 54 % , reached remission compared to the group receiving placebo/placebo , 89 % , p < 0.05 .


Among patients treated with Cipro/placebo and Cipro/EcN , 78 % and 66 % reached remission , respectively .


Furthermore , the group receiving placebo/EcN had the largest number of withdrawals , 11 of 25 ( 44 % ) , compared to 15 of 75 ( 20 % ) in any of the other groups , p < 0.05 .


Indication of lack of mucosal healing was found in the group treated with placebo/Nissle , since only 4 ( 29 % ) of the 14 patients , who completed the study , reported no blood in stools at week 12 ( p < 0.02 ) , compared to 63 % , 67 % and 65 % in groups treated with Cipro/Nissle , Cipro/placebo and placebo/placebo , respectively .


Our data suggest that there is no benefit in the use of E. coli Nissle as an add-on treatment to conventional therapies for active ulcerative colitis .


Furthermore , treatment with E. coli Nissle without a previous antibiotic cure resulted in fewer patients reaching clinical remission .


Perirectal spacing , whereby biomaterials are placed between the prostate and rectum , shows promise in reducing rectal dose during prostate cancer radiation therapy .


A prospective multicenter randomized controlled pivotal trial was performed to assess outcomes following absorbable spacer ( SpaceOAR system ) implantation .


Overall , 222 patients with clinical stage T1 or T2 prostate cancer underwent computed tomography ( CT ) and magnetic resonance imaging ( MRI ) scans for treatment planning , followed with fiducial marker placement , and were randomized to receive spacer injection or no injection ( control ) .


Patients received postprocedure CT and MRI planning scans and underwent image guided intensity modulated radiation therapy ( 79.2 Gy in 1.8-Gy fractions ) .


Spacer safety and impact on rectal irradiation , toxicity , and quality of life were assessed throughout 15months .


Spacer application was rated as `` easy '' or `` very easy '' 98.7 % of the time , with a 99 % hydrogel placement success rate .


Perirectal spaces were 12.63.9 mm and 1.62.0 mm in the spacer and control groups , respectively .


There were no device-related adverse events , rectal perforations , serious bleeding , or infections within either group .


Pre-to postspacer plans had a significant reduction in mean rectal V70 ( 12.4 % to 3.3 % , P < .0001 ) .


Overall acute rectal adverse event rates were similar between groups , with fewer spacer patients experiencing rectal pain ( P = .02 ) .


A significant reduction in late ( 3-15months ) rectal toxicity severity in the spacer group was observed ( P = .04 ) , with a 2.0 % and 7.0 % late rectal toxicity incidence in the spacer and control groups , respectively .


There was no late rectal toxicity greater than grade 1 in the spacer group .


At 15months 11.6 % and 21.4 % of spacer and control patients , respectively , experienced 10-point declines in bowel quality of life .


MRI scans at 12months verified spacer absorption .


Spacer application was well tolerated .


Increased perirectal space reduced rectal irradiation , reduced rectal toxicity severity , and decreased rates of patients experiencing declines in bowel quality of life .


The spacer appears to be an effective tool , potentially enabling advanced prostate RT protocols .


In older adults reduced mobility is common and is an independent risk factor for morbidity , hospitalization , disability , and mortality .


Limited evidence suggests that physical activity may help prevent mobility disability ; however , there are no definitive clinical trials examining whether physical activity prevents or delays mobility disability .


To test the hypothesis that a long-term structured physical activity program is more effective than a health education program ( also referred to as a successful aging program ) in reducing the risk of major mobility disability .


The Lifestyle Interventions and Independence for Elders ( LIFE ) study was a multicenter , randomized trial that enrolled participants between February 2010 and December 2011 , who participated for an average of 2.6 years .


Follow-up ended in December 2013 .


Outcome assessors were blinded to the intervention assignment .


Participants were recruited from urban , suburban , and rural communities at 8 centers throughout the United States .


We randomized a volunteer sample of 1635 sedentary men and women aged 70 to 89 years who had physical limitations , defined as a score on the Short Physical Performance Battery of 9 or below , but were able to walk 400 m.


Participants were randomized to a structured , moderate-intensity physical activity program ( n = 818 ) conducted in a center ( twice/wk ) and at home ( 3-4 times/wk ) that included aerobic , resistance , and flexibility training activities or to a health education program ( n = 817 ) consisting of workshops on topics relevant to older adults and upper extremity stretching exercises .


The primary outcome was major mobility disability objectively defined by loss of ability to walk 400 m.


Incident major mobility disability occurred in 30.1 % ( 246 participants ) of the physical activity group and 35.5 % ( 290 participants ) of the health education group ( hazard ratio [ HR ] , 0.82 [ 95 % CI , 0.69-0 .98 ] , P = .03 ) .


Persistent mobility disability was experienced by 120 participants ( 14.7 % ) in the physical activity group and 162 participants ( 19.8 % ) in the health education group ( HR , 0.72 [ 95 % CI , 0.57-0 .91 ] ; P = .006 ) .


Serious adverse events were reported by 404 participants ( 49.4 % ) in the physical activity group and 373 participants ( 45.7 % ) in the health education group ( risk ratio , 1.08 [ 95 % CI , 0.98-1 .20 ] ) .


A structured , moderate-intensity physical activity program compared with a health education program reduced major mobility disability over 2.6 years among older adults at risk for disability .


These findings suggest mobility benefit from such a program in vulnerable older adults .


clinicaltrials.gov Identifier : NCT01072500 .


This study was conducted to assess the effectiveness of combinations of Ayurvedic drugs in alleviating the toxicity of chemotherapy and improving the quality of life of cancer patients .


The following was the research question : Can Ayurvedic drugs be used to alleviate the side effects of chemotherapy and improve the quality of life of cancer patients ?


Random patients with malignancies of different tissues , grades , and stages were divided into two groups according to their treatment modality .


Group 1 consisted of 15 patients treated with six cycles of chemotherapy alone and who did not receive any Ayurvedic drugs ( control group ) .


Group 2 consisted of patients ( divided into three arms ) who received Ayurvedic drugs during chemotherapy and after chemotherapy .


Nineteen patients in arm 1 received the Ayurvedic drugs Mauktikyukta Kamdudha ( MKD ) and Mauktikyukta Praval Panchamruta ( MPP ) along with a full course of chemotherapy .


Fifteen patients in arm 2 received the same Ayurvedic treatment , but the treatment was started after completing the sixth cycle of chemotherapy .


Eighteen patients in arm 3 received the Suvarnabhasmadi formulation ( SBD ) in addition to MKD and MPP after completing the sixth cycle of chemotherapy .


Treatment was given for 16 weeks in all three arms .


Patients from both groups were observed for a period of 6 months .


The assessment criteria depended on Common Toxicity Criteria ( CTC designed by NIH and NCI ) : haemogram ; weight ; physical examination including Quality of Life Questionnaire ( QLQ designed by the European Organization of Research and Treatment of Cancer ( EORTC ) ) for functional , symptom and global scores ; and Karnofsky score for assessment of general well-being and activities of daily life .


ECOG ( Eastern Cooperation Oncology Group ) score was also additionally included for assessment of symptoms .


From amongst the symptomatic criteria , there was significant improvement in all the three arms compared with the control group in nausea , loss of appetite , constipation , and fatigue .


There was significant improvement in the Karnofsky score and global score of the QLQ , which in fact incorporate symptomatic criteria , general condition , functional ability and disease-related symptoms .


These significant differences were observed in group 2 ( arms 1 , 2 , 3 ) in comparison with group 1 ( control ) , in spite of the fact that in arms 2 and 3 , the Ayurvedic treatment was started after completion of chemotherapy .


The haemogram did not show a significant difference between the control and the three arms of group 2 .


Adjunct treatment with herbo-mineral and metallic Ayurvedic drugs appears to have a significant effect on reducing the toxic side effects of chemotherapy drugs in cancer patients .


Our preliminary data suggests that Ayurvedic treatment should be given simultaneously from the beginning of chemotherapy to have the desired effect .


However , there is a need to extend this work by conducting a well-planned two-armed study on cancer patients with defined cancer sites with selected Ayurvedic drug combinations , and observing the patients for a longer period of time to confirm the effectiveness of Ayurvedic drugs in reducing the side effects of chemotherapy .


There is no widely accepted treatment for non-alcoholic fatty liver disease ( NAFLD ) or its advanced form , non-alcoholic steatohepatitis ( NASH ) .


We administered rosuvastatin ( 10 mg/day ) for 1 year in patients with metabolic syndrome ( MetS ) , NASH on liver biopsy and dyslipidaemia ( but without diabetes or arterial hypertension ) .


Patients also received lifestyle advice .


We report preliminary results for 6 patients .


The second biopsy ( at the end of the study ) showed complete resolution of NASH in 5 patients , while the 6 ( th ) , which had no improvement , developed arterial hypertension and substantial rise in triglyceride levels during the study .


We suspect alcohol abuse despite advice to abstain .


Serum alanine transaminase ( ALT ) and aspartate transaminase ( AST ) activities were reduced by 76 and 61 % , respectively ( p < 0.001 for both ) , during treatment , while - glutamyl transpeptidase ( - GT ) , and alkaline phosphatase ( AP ) showed smaller non significant reductions .


Fasting plasma glucose and glycated haemoglobin ( HbA1c ) were significantly reduced ( p < 0.05 ) .


Lipid values were totally normalised and liver ultrasonography showed a complete resolution of NASH in 5 patients .


Body mass index and waist circumference remained unchanged during the study .


Thus , changes in liver pathology and function should be attributed to treatment with rosuvastatin .


A substantial limitation of the study is the small number of patients .


These preliminary findings suggest that rosuvastatin could ameliorate NASH within a year of treatment in MetS patients with dyslipidaemia .


We tested whether a structural intervention combining savings-led microfinance and HIV prevention components would achieve enhanced reductions in sexual risk among women engaging in street-based sex work in Ulaanbaatar , Mongolia , compared with an HIV prevention intervention alone .


Between November 2011 and August 2012 , we randomized 107 eligible women who completed baseline assessments to either a 4-session HIV sexual risk reduction intervention ( HIVSRR ) alone ( n = 50 ) or a 34-session HIVSRR plus a savings-led microfinance intervention ( n = 57 ) .


At 3 - and 6-month follow-up assessments , participants reported unprotected acts of vaginal intercourse with paying partners and number of paying partners with whom they engaged in sexual intercourse in the previous 90 days .


Using Poisson and zero-inflated Poisson model regressions , we examined the effects of assignment to treatment versus control condition on outcomes .


At 6-month follow-up , the HIVSRR plus microfinance participants reported significantly fewer paying sexual partners and were more likely to report zero unprotected vaginal sex acts with paying sexual partners .


Findings advance the HIV prevention repertoire for women , demonstrating that risk reduction may be achieved through a structural intervention that relies on asset building , including savings , and alternatives to income from sex work .


This article describes the rationale , design and methodology of the Building research initiative group : chronic illness management and adherence in transplantation ( BRIGHT ) study .


This study of heart transplant patients will : ( 1 ) describe practice patterns relating to chronic illness management ; ( 2 ) assess prevalence and variability of non-adherence to the treatment regimen ; ( 3 ) determine the multi-level factors related to immunosuppressive medication non-adherence .


The unaltered long-term prognosis after heart transplantation underscores an urgent need to identify and improve factors related to survival outcomes .


The healthcare system ( e.g. level of chronic illness management implemented ) and patient self-management are major drivers of outcome improvement .


The study uses a survey design in 40 heart transplant centres covering 11 countries in four continents .


Theoretical frameworks informed variable selection , which are measured by established and investigator-developed instruments .


Heart transplant recipients , outpatient clinicians and programme 's directors complete a survey .


A staged convenience sampling strategy is implemented in heart transplant centres , countries and continents .


Depending on the centre 's size , a random sample of 25-60 patients is selected ( N estimated 1680 heart transplant recipients ) .


Five randomly selected clinicians and the medical director from each centre will be invited to participate .


This is the first multi-centre , multi-continental study examining healthcare system and heart transplant centres chronic illness management practice patterns and potential correlates of immunosuppressive medication non-adherence .


The knowledge gained will inform clinicians , researchers and healthcare policy makers at which level ( s ) interventions need to be implemented to improve long-term outcomes for transplant recipients .


Increased body mass index and weight gain are risk factors for psoriasis , and the prevalence of obesity in patients with psoriasis is higher than in the general population .


Limited data exist regarding the role of diet in psoriasis .


To assess the impact of a dietary intervention combined with physical exercise for weight loss on improving psoriasis in overweight or obese patients .


This study included 303 overweight or obese patients with moderate-to-severe chronic plaque psoriasis who did not achieve clearance after 4 weeks of continuous systemic treatment .


They were randomized to receive either a 20-week quantitative and qualitative dietary plan associated with physical exercise for weight loss or simple informative counselling at baseline about the utility of weight loss for clinical control of psoriatic disease .


The main outcome was any reduction of the Psoriasis Area and Severity Index ( PASI ) from baseline to week 20 .


Intention-to-treat analysis showed a median PASI reduction of 48 % ( 95 % confidence interval 33.3-58 .3 % ) in the dietary intervention arm and 25.5 % ( 95 % confidence interval 18.2-33 .3 % ) in the information-only arm ( P = 0.02 ) .


Among secondary outcomes , PASI score reduction of 50 % significantly differed between study arms ( 49.7 % with dietary intervention vs. 34.2 % with information only , P = 0.006 ) .


The weight-loss target ( a 5 % reduction from baseline ) was reached by 29.8 % of patients in the dietary intervention arm compared with 14.5 % in the information-only arm ( P = 0.001 ) .


A 20-week dietetic intervention associated with increased physical exercise reduced psoriasis severity in systemically treated overweight or obese patients with active psoriasis .


According to the results of the international study Relapsed AML 2001/01 response was better after re-induction with L-DNR/FLAG ( liposomal daunorubicin , fludarabine , cytarabine , G-CSF ) compared to FLAG only but survival rate was not improved .


However , the findings might be group-specific .


Patient characteristics , actual therapy given and long-term course of the disease in 155 pediatric patients ( including non-randomized ) with first relapse and 10 primary nonresponders treated in Germany were analyzed .


Overall 4-year survival rates after relapse were similar in the 2 treatment groups L-DNR/FLAG and FLAG ( 0.43 0.05 vs. 0.47 0.06 , p ( log-rank ) = 0.47 ) .


The rate of randomization was low ( 65 % ) and 5 % of the 101 randomized patients changed the treatment arm .


Therefore , induction was based in 40 % patients on an individual decision with preference for L-DNR/FLAG .


There were less patients with favorable cytogenetics and morphology in the L-DNR/FLAG-group ( p < 0.04 ) .


Response to the first re-induction course at day 28 tended to be more unfavorable with FLAG only .


In this patient group protocol intensifications were more frequent as compared to the L-DNR/FLAG-group ( p = 0.07 ) , and late CR could be achieved after intensification in 9/18 poor responding patients .


The initial selection bias of relapse patients with unfavorable risk factors to the disadvantage of the L-DNR/FLAG-group and the more drug - and time-intensive treatment after 1 ( st ) re-induction given in the FLAG-group may have nullified the initial beneficial effect of L-DNR containing re-induction therapy and led to similar and relatively favorable survival rates in both treatment groups in Germany .


Vitamin D insufficiency drives secondary hyperparathyroidism ( SHPT ) and is associated with increased cardiovascular mortality in patients with chronic kidney disease ( CKD ) .


SHPT is poorly addressed by current vitamin D repletion options .


The present study evaluated a novel investigational vitamin D repletion therapy : a modified-release ( MR ) formulation of calcifediol designed to raise serum 25-hydroxyvitamin D in a gradual manner to minimize the induction of CYP24 and , thereby , improve the SHPT control .


This randomized , double-blind , placebo-controlled trial evaluated MR calcifediol in CKD subjects ( n = 78 ) with plasma intact parathyroid hormone ( iPTH ) > 70 pg/ml and serum total 25-hydroxyvitamin D < 30 ng/ml .


Subjects received daily treatment for six weeks with oral MR calcifediol ( 30 , 60 or 90 g ) or a placebo .


More than 90 % of subjects treated with MR calcifediol achieved serum 25-hydroxyvitamin D levels 30 ng/ml versus 3 % of subjects treated with placebo ( p < 0.0001 ) .


Mean plasma iPTH decreased from baseline ( 140.3 pg/ml ) by 20.9 6.2 % ( SE ) , 32.8 5.7 and 39.3 4.3 % in the 30 , 60 and 90 g dose groups , respectively , and increased 17.2 7.8 % in the pooled placebo group ( p < 0.005 ) .


No clinically significant safety concerns arose during MR calcifediol treatment .


Oral MR calcifediol appears safe and highly effective in treating SHPT associated with vitamin D insufficiency in CKD .


Chronic autoimmune thyroiditis ( CAT ) ( chronic lymphocytic thyroiditis-Hashimoto 's thyroiditis ) , which is the most common inflammatory disorder of the thyroid gland , causes hypothyroidism .


Ultrasound elastography is a newly developed sonographic technique that provides an estimation of tissue elasticity by measuring the degree of tissue displacement under the application of an external force .


In this study , our aim was to evaluate the accuracy of strain index ratio with real-time ultrasound elastography and to calculate the cut-off point for the diagnosis of CAT .


Our aim was also to lead further studies on other pathological changes such as lymphoma , malign nodules etc. based on CAT by using this cut-off point .


The gains from this study and further studies will assist clinical diagnoses and follow-up .


Aplio 500 ultrasound machine ( Toshiba Medical Systems Co. Ltd , Otawara , Japan ) with linear 4.8-11 .0 MHz transducers and elastography software was used .


Routine B-mode ( dimensions and parenchymal echogenicity ) ultrasound evaluation was performed prior to the ultrasound elastography .


A total of 31 randomized patients ( 3 males , 28 females ) with a mean age of 39.1310.16 years ( range , 16-58 years ) with CAT and 21 healthy controls ( 6 males , 15 females ) with mean age of 34.6716.31 years ( range , 14-81 years ) were prospectively examined .


The mean values of thyroid-stimulating hormone ( TSH ; normal TSH value is 0.27-4 .20 IUml ( -1 ) ) and anti-thyroid peroxidase ( anti-TPO ; normal anti-TPO value is 0-34IUml ( -1 ) ) were 3.402.70 and 373.66148.94 IUml ( -1 ) , respectively .


No correlation was detected between serum TSH and thyroid tissue strain index ( Spearman r coefficient of TSH was -0.290 ) .


Positive-sided correlation was detected between anti-TPO values and thyroid tissue strain index ratio ( Spearman r coefficient of anti-TPO was 0.682 ) .


The median strain index ratio of patients with CAT ( 1.390.72 ) was significantly higher than the mean ratio of the controls ( 0.760.55 ) .


The area under the receiver operating characteristic curve was 0.775 ( 95 % confidence interval ) .


The optimal cut-off value ( in which the sum of sensitivity and specificity was highest ) for the prediction of diffuse thyroid pathology was 0.677 .


For this cut-off ratio , thyroid stiffness had 96 % sensitivity and 67 % specificity .


A total of 30 of 31 patients ( 96 % ) and a total of 7 of 21 healthy controls ( 33 % ) exceeded the cut-off points .


The strain index ratio was higher in CAT than in normal thyroid parenchyma in real-time ultrasound elastography .


Thus , it seems to be a useful method for the assessment of CAT with real-time ultrasound elastography , and further studies assessing the correlation of sonoelastography findings and histopathological subtypes of CAT would enrich the findings of the present study .


In our study , we detected the stiffness ratio of the thyroid tissue in patients with CAT .


The cut-off value should be helpful for diagnosis or follow-up of the recently developed lesions such as lymphoma , malign nodule , etc. based on CAT .


This study should also encourage new studies about CAT and ultrasound elastography .


The aim of the present study was to evaluate the surgical and obstetric results of laparoscopy versus laparotomy in the management of ovarian cyst during pregnancy .


Sixty-nine eligible patients who met our criteria were randomly divided into the laparoscopy group ( n = 33 ) and the laparotomy group ( n = 36 ) .


The two groups were compared for their surgical and obstetric outcomes and the extent of pelvic adhesion discovered in later cesarean section ( CS ) .


The laparoscopy group had less blood loss ( 4315 vs 5113mL , P = 0.02 ) , shorter postoperative hospital stay ( 2.90.5 vs 5.80.6 days , P < 0.001 ) , and lower postoperative pain score ( 2.71.2 vs 5.91.5 , P < 0.001 ) compared with the laparotomy group .


The operative time , neonates ' Apgar scores and birthweights between the two groups showed no significant differences ( P > 0.05 ) .


Sixteen patients in the laparoscopy group , and 15 patients in the laparotomy group underwent cesarean section .


The filmy and dense type adhesion rate was significantly different between the laparoscopy group and the laparotomy group ( 6.25 % vs 53.3 % , and 0 % vs 20 % , respectively ) .


The present results suggest that laparoscopy is a better choice than laparotomy for ovarian cyst during pregnancy , with less blood loss , less postoperative pain and less postoperative hospital stay .


It offers a faster recovery , results in less pelvic adhesion and does not affect the fetus ; however , studies encompassing larger numbers of cases are needed .


Exemestane , a steroidal aromatase inhibitor , reduced invasive breast cancer incidence by 65 % among 4,560 postmenopausal women randomly assigned to exemestane ( 25 mg per day ) compared with placebo in the National Cancer Institute of Canada ( NCIC ) Clinical Trials Group MAP .3 ( Mammary Prevention 3 ) trial , but effects on quality of life ( QOL ) were not fully described .


Menopause-specific and health-related QOL were assessed by using the four Menopause-Specific Quality of Life Questionnaire ( MENQOL ) domains and the eight Medical Outcomes Study Short Form Health Survey ( SF-36 ) scales at baseline , 6 months , and yearly thereafter .


MENQOL questionnaire completion was high ( 88 % to 98 % ) in both groups at each follow-up visit .


Change scores for each MENQOL and SF-36 scale , calculated at each assessment time relative to baseline , were compared by using the Wilcoxon rank-sum test .


Clinically important worsened QOL was defined as a MENQOL change score increase of more than 0.5 ( of 8 ) points and an SF-36 change score decrease of more than 5 ( of 100 ) points from baseline .


Exemestane had small negative effects on women 's self-reported vasomotor symptoms , sexual symptoms , and pain , which occurred mainly in the first 6 months to 2 years after random assignment .


However , these changes represented only a small excess number of women being given exemestane with clinically important worsening of QOL at one time or another ; specifically , 8 % more in the vasomotor domain and 4 % more each in the sexual domain and for pain .


No other between-group differences were observed .


Overall , slightly more women in the exemestane arm ( 32 % ) than in the placebo arm ( 28 % ) discontinued assigned treatment .


Exemestane given for prevention has limited negative impact on menopause-specific and health-related QOL in healthy postmenopausal women at risk for breast cancer .


To explore the efficacy and safty of sorafenib in Child-Pugh class B to class C hepatocellular carcinoma ( HCC ) .


In this three-center open-label study from November 2011 to May 2013 , we randomly assigned 189 patients with advanced Child-Pugh class B or C HCC patients into two groups , one group with 95 patient to receive sorafenib ( 400 mg a time , twice a day ) and the other group with 94 patients to receive best supportive care .


The primary end points were progression-free survival and overall survival .


The median progression-free survival was 2.2 months and 1.9 months in the sorafenib group and best supportive care group respectively ( Hazard ratio in the sorafenib group , 0.55 ; 95 % confidence interval , 0.40-0 .75 ; P = 0.002 ) .


The median overall survival was 4.0 months and 3.5 months in the sorafenib group and best supportive care group respectively ( Hazard ratio in the sorafenib group , 0.48 ; 95 % confidence interval , 0.35-0 .68 ; P < 0.001 ) .


The main adverse effect of sorafenib was rash and acne of the skin ( in 51.7 % patients ) .


The incidences of severe rash , diarrhea , and dry skin were 5.6 % , 5.6 % , and 2.2 % in the sorafenib group .


One patient reached partial response in the sorafenib group .


Sorafenib is safe in patients with liver function impaired advanced HCC .


It is effective in terms of progression-free survival and overall survival compared with best supportive care .


Liver functions are the important predictive factors .


Cardiovascular disease ( CVD ) is an important worldwide cause of mortality .


In The Netherlands , CVD is the leading cause of death for women and the second cause of death for men .


Recommendations for diagnosis and treatment of CVD are not well implemented in primary care .


In this study , we aim to examine the effectiveness of a tailored implementation program targeted at practice nurses to improve healthcare for patients with ( high risk for ) CVD .


A two-arm cluster randomized trial is planned .


We offer practice nurses a tailored program to improve adherence to six specific recommendations related to blood pressure and cholesterol target values , risk profiling and lifestyle advice .


Practice nurses are offered training and feedback on their motivational interviewing technique and an e-learning program on cardiovascular risk management ( CVRM ) .


They are also advised to screen for the presence and severity of depressive symptoms in patients .


We also advise practice nurses to use selected E-health options ( selected websites and Twitter-consult ) in patients without symptoms of depression .


Patients with mild depressive symptoms are referred to a physical exercise group .


We recommend referring patients with major depressive symptoms for assessment and treatment of depressive symptoms if appropriate before starting CVRM .


Data from 900 patients at high risk of CVD or with established CVD will be collected in 30 general practices in several geographical areas in The Netherlands .


The primary outcome measure is performance of practice nurses in CVRM and reflects application of recommendations for personalized counselling and education of CVRM patients .


Patients ' health-related lifestyles ( physical exercise , diet and smoking status ) will be measured with validated questionnaires and medical record audit will be performed to document estimated CVD risk .


Additionally , we will survey and interview participating healthcare professionals for exploration of processes of change .


The control practices will provide usual care .


Tailored interventions can improve healthcare .


An understanding of the methods to reach the improved healthcare can be improved .


This research contributes a share of it .


Identification of the determinants of practice and developing implementation interventions were two steps which were completed .


The subsequent step was implementation of the tailored intervention program .


Name trial register : Nederlands trial register .


Web address of trial register : http://www.trialregister.nl .


Data of registration : 11 July 2013 .


Number of registration : NTR4069 .


This randomised phase III trial evaluated first-line trabectedin versus doxorubicin-based chemotherapy ( DXCT ) in patients with advanced/metastatic translocation-related sarcomas ( TRS ) .


Patients were randomly assigned ( 1:1 ) to receive trabectedin 1.5 mg/m2 24-h intravenous ( i.v. ) infusion every 3 weeks ( q3wk ) ( Arm A ) , or doxorubicin 75 mg/m2 i.v. , q3wk , or doxorubicin 60 mg/m2 i.v. plus ifosfamide ( range , 6-9 g/m2 ) i.v. q3wk ( Arm B ) .


Progression-free survival ( PFS ) by independent review was the primary efficacy end-point .


One hundred and twenty-one patients were randomised ; 88 of them had TRS confirmed by central pathology review ( efficacy population ) .


Twenty-nine PFS events were assessed by independent review ( 16 with trabectedin ; 13 with DXCT ) .


PFS showed non-significant difference between arms ( stratified log rank test , p = 0.9573 ; hazard ratio = 0.86 , p = 0.6992 ) .


At the time of this analysis , 63.9 % and 58.3 % of patients were alive in trabectedin and DXCT arms , respectively .


There was no statistically significant difference in survival curves .


Response rate according to Response Evaluation Criteria in Solid Tumours ( RECIST ) v. 1.0 was significantly higher in DXCT arm ( 27.0 % versus 5.9 % ) , but response according to Choi criteria showed fewer differences between treatment arms ( 45.9 % versus 37.3 % ) .


Safety profile was as expected for both arms , with higher incidence of severe neutropenia , alopecia and mucositis in the DXCT arm .


Neither trabectedin nor doxorubicin-based chemotherapy showed significant superiority in the first-line treatment of patients with advanced translocation-related sarcoma .


Multicenter randomized trial with patients listed as sick for 1 to 12 months due to neck or back pain and referred to secondary care .


To compare the return-to-work ( RTW ) rate among patients offered work-focused rehabilitation or multidisciplinary rehabilitation .


A growing number of studies have focused on the RTW processes associated with patients with back pain .


Many studies have combined a workplace focus with multidisciplinary treatments ; however , this focus has not been evaluated in Norway among patients with neck and back pain thus far .


A total of 405 patients who were referred to the spine clinics at 2 university hospitals in Norway were randomly assigned into work-focused and control intervention groups .


The existing treatments at each hospital were used as the control interventions , which entailed either a comprehensive multidisciplinary intervention or a brief multidisciplinary intervention .


The RTW rates and proportions were compared at 12 months .


During the first 12 months after inclusion , 142 ( 70 % ) participants in the work-focused rehabilitation group and 152 ( 75 % ) participants in the control group returned to work .


The median time to RTW was 161 days in the work-focused group and 158 days in the control group .


A comparison of the work-focused and control interventions revealed a relative RTW probability ( hazard ratio ) of 0.94 ( 95 % confidence interval = 0.75-1 .17 ) after adjusting for age , sex , and education .


The results suggest that a focus on the workplace in specialist care does not substantially alter the RTW rate compared with standard multidisciplinary treatments .


Compared with open resection , laparoscopic resection of rectal cancers is associated with improved short-term outcomes , but high-level evidence showing similar long-term outcomes is scarce .


We aimed to compare survival outcomes of laparoscopic surgery with open surgery for patients with mid-rectal or low-rectal cancer .


The Comparison of Open versus laparoscopic surgery for mid or low REctal cancer After Neoadjuvant chemoradiotherapy ( COREAN ) trial was an open-label , non-inferiority , randomised controlled trial done between April 4 , 2006 , and Aug 26 , 2009 , at three centres in Korea .


Patients ( aged 18-80 years ) with cT3N0-2M0 mid-rectal or low-rectal cancer who had received preoperative chemoradiotherapy were randomly assigned ( 1:1 ) to receive either open or laparoscopic surgery .


Randomisation was stratified by sex and preoperative chemotherapy regimen .


Investigators were masked to the randomisation sequence ; patients and clinicians were not masked to the treatment assignments .


The primary endpoint was 3 year disease-free survival , with a non-inferiority margin of 15 % .


Analysis was by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT0040951 .


We randomly assigned 340 patients to receive either open surgery ( n = 170 ) or laparoscopic surgery ( n = 170 ) .


3 year disease-free survival was 725 % ( 95 % CI 650-786 ) for the open surgery group and 792 % ( 723-846 ) for the laparoscopic surgery group , with a difference that was lower than the prespecified non-inferiority margin ( -67 % , 95 % CI -158 to 24 ; p < 00001 ) .


25 ( 15 % ) patients died in the open group and 20 ( 12 % ) died in the laparoscopic group .


No deaths were treatment related .


Our results show that laparoscopic resection for locally advanced rectal cancer after preoperative chemoradiotherapy provides similar outcomes for disease-free survival as open resection , thus justifying its use .


National Cancer Center , South Korea .


Great strides have been made in improving heart health in the United States during the last 2 decades , yet these strides have not encompassed many ethnic minority populations .


There are significant health disparity gaps stemming from both a paucity of valid research and a lack of culturally sensitive interventions .


In particular , many Korean Americans with chronic illnesses encounter difficulty navigating the healthcare system because of limited health literacy .


The effect of a multimodal Self-Help Intervention Program on the Control of High Blood Pressure ( HBP ) was tested in a community-based clinical trial for Korean American seniors .


Of 440 seniors enrolled , 369 completed the study ( 184 in the intervention group and 185 in the control group ; mean age = 70.95.3 years ) .


The intervention group received 6 weekly educational sessions on HBP management skill building , including health literacy training , followed by telephone counseling and home blood pressure ( BP ) monitoring for 12 months .


Findings support that the Self-Help Intervention Program on the Control of HBP was effective in controlling BP in this ethnic/linguistic minority population .


The BP control rates for the intervention and control groups were 49.5 % vs. 43.2 % at baseline , 58.5 % vs. 42.4 % at 6 months , 67.9 % vs. 52.5 % at 12 months , and 54.3 % vs. 53.0 % at 18 months .


Significant changes were observed over time in some psychobehavioral outcomes , including self-efficacy for BP control , medication adherence behavior , HBP knowledge , and depression .


The study findings suggest that the multimodal Self-Help Intervention Program on the Control of HBP is effective at promoting optimal HBP control for this ethnic/linguistic minority population .


NCT00406614 .


To investigate the impact of education on the quality of life of parent of children with leukemia referred to the oncology clinic at Kerman 's Afzali-Poor hospital ( Iran ) .


This was an interventional study with 80 parents of children with leukemia ; all of the caregivers were mothers and were included in the research .


They were chosen using the convenience sampling method and categorized randomly into two groups ( intervention and control , each with 40 participants ) .


Research tools included demographic information and Quality of Life ( QoL ) scale ( a specific form for first-degree family caregivers of patients with leukemia ) .


Questionnaires were applied at the beginning of the research and after three months ; this second evaluation coincided in the study group with the end of the intervention .


The intervention lasted four sessions of 45 - to 65-minute classes , with lectures and question and answer sessions , educational booklets , and posters in groups with 4 - 6 members .


In the first evaluation , mean QoL scores in the study and control groups were 224.9 and 225.7 , which , after three months changed to 338.2 and 226.7 , respectively .


T-test verified these increases ( p < 0.05 ) in quality of life in the intervention group .


According to the effectiveness of the education on the parent 's quality of life , it is recommended to implement consulting and educational programs for parents , especially parents of children with leukemia , to promote care , reduce anxiety , and consequently , enhance quality of life .


To determine the response of nebulized magnesium sulfate on the lung function of acetylcholine-induced asthma children .


Three hundred and thirty children of asthma with positive bronchial provocation test were randomly divided into three groups : magnesium sulfate , albuterol , and a combination of magnesium sulfate and albuterol .


Lung function was compared between the three groups .


Forced expiratory volume in one second ( FEV1 ) and peak expiratory flow ( PEF ) as percentage over predicted at 10 min and 20 min in albuterol and combination group were significantly improved when compared to magnesium group .


The changes in FEV1 and PEF expressed as absolute and percentage over predicted was not statistically significant from baseline to 20 min in magnesium , albuterol , and combination of magnesium sulfate and albuterol .


There was no significant adverse effect observed during the present study .


Nebulized magnesium sulfate alone has a bronchodilatory effect in Ach-induced asthmatic children .


The combination of MgSO4 and albuterol did not has a synergistic effect .


Genome-wide association studies have yet to identify the majority of genetic variants involved in asthma .


We hypothesized that expression quantitative trait locus ( eQTL ) mapping can identify novel asthma genes by enabling prioritization of putative functional variants for association testing .


We evaluated 6706 cis-acting expression-associated variants ( eSNPs ) identified through a genome-wide eQTL survey of CD4 ( + ) lymphocytes for association with asthma .


eSNPs were tested for association with asthma in 359 asthmatic patients and 846 control subjects from the Childhood Asthma Management Program , with verification by using family-based testing .


Significant associations were tested for replication in 579 parent-child trios with asthma from Costa Rica .


Further functional validation was performed by using formaldehyde-assisted isolation of regulatory elements ( FAIRE ) quantitative PCR and chromatin immunoprecipitation PCR in lung-derived epithelial cell lines ( Beas-2B and A549 ) and Jurkat cells , a leukemia cell line derived from T lymphocytes .


Cis-acting eSNPs demonstrated associations with asthma in both cohorts .


We confirmed the previously reported association of ORMDL3/GSDMB variants with asthma ( combined P = 2.9 10 ( -8 ) ) .


Reproducible associations were also observed for eSNPs in 3 additional genes : fatty acid desaturase 2 ( FADS2 ; P = .002 ) , N-acetyl -- D-galactosaminidase ( NAGA ; P = .0002 ) , and Factor XIII , A1 ( F13A1 ; P = .0001 ) .


Subsequently , we demonstrated that FADS2 mRNA is increased in CD4 ( + ) lymphocytes in asthmatic patients and that the associated eSNPs reside within DNA segments with histone modifications that denote open chromatin status and confer enhancer activity .


Our results demonstrate the utility of eQTL mapping in the identification of novel asthma genes and provide evidence for the importance of FADS2 , NAGA , and F13A1 in the pathogenesis of asthma .


To observe the clinical therapeutic effect of blood-letting plus acupuncture intervention for acute facial paralysis with pain ( damp-heat type of liver and gallbladder ) .


A total of 120 cases of acute facial paralysis with pain were randomly and equally divided into control group and treatment group .


Patients of the control group were treated by simple acupuncture therapy only , and patients of the treatment group treated by acupuncture plus bloodletting at the ipsilateral Yangbai ( GB 14 ) and Quanliao ( SI 18 ) , and Dazhui ( GV 14 ) and Yifeng ( TE 17 ) , alternatively .


Shallow-acupuncture stimulation of ipsilateral Cuanzhu ( BL 2 ) , Sizhukong ( TE 23 ) , Sibai ( ST 2 ) , Dicang ( ST 4 ) , Jiache ( ST 6 ) , Yingxiang ( SP 9 ) , and bilateral Hegu ( LI 4 ) , Yanglingquan ( GB 34 ) and Xingjian ( LR 2 ) was administered for 30 min , once daily for one month .


The patients ' facial pain degree was evaluated by visual analogue scale ( VAS ) , and the pain duration during acute stage was recorded .


The facial nerve function and facial nerve function recovery ( grade II ) time were determined by using Sunnybrook Facial Grading scale and House-Brackmann ( HB ) grading scale , respectively .


In comparison with pre-treatment , the post-aurem pain scores after the first treatment and after the acute stage were significantly decreased , and the facial nerve function scores after the treatment were significantly increased in both control and treatment groups ( P < 0.01 ) , and the effects of the treatment group were significantly superior to those of the control group ( P < 0.01 ) .


The post-aurem pain duration and the time of facial nerve function recovery ( HB ) of the treatment group were considerably lower than those of the control group ( P < 0.01 ) .


Of the 58 and 59 facial palsy patients in the control and treatment groups , 16 ( 27.6 % ) and 24 ( 40.7 % ) were cured , 18 ( 31.0 % ) and 23 ( 39.0 % ) experienced marked improvement , 15 ( 25.9 % ) and 10 ( 16.9 % ) were improved , and 9 ( 15.5 % ) and 2 ( 3.4 % ) were failed , with the effective rate being 85.0 % and 96.6 % , respectively .


Bloodletting combined acupuncture is effective in the treatment of acute facial paralysis with pain .


Therapy for stroke prevention in older persons with atrial fibrillation ( AF ) is underutilized despite evidence to support its effectiveness .


To prevent stroke in this high-risk population , antithrombotic treatment is necessary .


Given the challenges and inherent risks of antithrombotic therapy , decision-making is particularly complex for clinicians , necessitating comprehensive risk : benefit assessments .


Targeted interventions are urgently needed to support clinicians in this context ; the Computerized Antithrombotic Risk Assessment Tool ( CARAT ) offers a unique approach to this clinical problem .


This study ( a prospective , cluster-randomized controlled clinical trial ) will be conducted across selected regions in the state of New South Wales , Australia .


Fifty GPs will be randomized to either the ` intervention ' or ` control ' arm , with each GP recruiting 10 patients ( aged 65 with AF ) ; target sample size is 500 patients .


GPs in the intervention arm will use CARAT during routine patient consultations to : assess risk factors for stroke , bleeding and medication misadventure ; quantify the risk/benefit ratio of antithrombotic treatment , identify the recommended therapy , and decide on the treatment course , for an individual patient .


CARAT will be applied by the GP at baseline and repeated at 12 months to identify any changes to treatment requirements .


At baseline , the participant ( patients and GPs ) characteristics will be recorded , as well as relevant practice and clinical parameters .


Patient follow up will occur at 1 , 6 , and 12 months via telephone interview to identify changes to therapy , medication side effects , or clinical events .


This project tests the utility of a novel decision support tool ( CARAT ) in improving the use of preventative therapy to reduce the significant burden of stroke .


Importantly , it targets the interface of patient care ( general practice ) , addresses the at-risk population , evaluates clinical outcomes , and offers a tool that may be sustainable via integration into prescribing software and primary care services .


GP support and guidance in identifying at risk patients for the appropriate selection of therapy is widely acknowledged .


This trial will evaluate the impact of CARAT on the prescription of antithrombotic therapy , its longer-term impact on clinical outcomes including stroke and bleeding , and clinicians perceived utility of CARAT in practice .


Australian New Zealand Clinical Trials Registry : ACTRN12613000060741 .


To evaluate the clinical effectiveness of indirect composite restorations in permanent molars with excessive substance loss in pediatric patients who have undergone root canal treatments .


Molars of 29 pediatric patients underwent endodontic treatment .


Sixteen molars were restored with an indirect posterior composite resin restoration and 13 molars were restored with a direct posterior composite resin restoration .


The success of the restorations was evaluated for 2 years based on United States Public Health Service ( USPHS ) criteria , photographs after staining with basic fuchsine , and radiographic data .


Data obtained from both groups were compared using the Mann-Whitney U-test and Wilcoxon signed rank test .


Evaluation of the clinical and radiographic data revealed no observable , statistically significant differences between the posterior and the indirect posterior composites ( p > 0.05 ) .


However , evaluation of photos taken of the patients ' molars after staining with basic fuchsin revealed that direct posterior composites showed increased staining on the margins of the restorations after six months ( p < 0.05 ) .


Considering the difficulties of restoring endodontically treated permanent teeth with excessive substance loss in child patients , indirect restorations may be seen as a better option .


Salt intake has been implicated in the pathogenesis of abdominal aortic aneurysm ( AAA ) through studies in rodent models but not previously studied in humans .


The aim of this study was to examine the association between reported addition of salt to food and the prevalence of AAA .


A risk factor questionnaire which contained a question about salt intake was included as part of a population screening study for AAA in 11742 older men .


AAA presence was assessed by abdominal ultrasound imaging using a reproducible protocol .


The prevalence of AAA was 6.9 , 8.5 and 8.6 % in men who reported adding salt to food never , sometimes and always , respectively , p = 0.005 .


Addition of salt to food sometimes ( odds ratio [ OR ] : 1.22 , 95 % confidence interval [ CI ] : 1.03-1 .44 ) or always ( OR : 1.23 , 95 % CI 1.04-1 .47 ) was independently associated with AAA after adjustment for other risk factors including age , waist-hip ratio , blood pressure , history of hypertension , high cholesterol , angina , diabetes , myocardial infarction and stroke .


Salt intake was also independently associated with aortic diameter ( beta 0.023 , p = 0.012 ) .


In men with no prior history of hypertension , high cholesterol , angina , myocardial infarction or stroke ( n = 4185 ) , the association between addition of salt to food sometimes ( OR : 1.41 , 95 % CI 0.96-2 .08 ) or always ( OR : 1.52 , 95 % CI 1.04-2 .22 ) and AAA remained evident .


Reported salt intake is associated with AAA in older men .


Additional studies are needed to determine whether reducing salt intake would protect against AAA .


This study investigated how performance was affected after soccer players , in a postprandial state , ingested a 7 % carbohydrate ( CHO ) solution compared to a placebo ( 0 % CHO ) during a simulated soccer match .


Using a double-blind placebo-controlled design , 22 trained male league soccer players ( age : 24 7 years , wt : 73.4 12.0 kg , VO2max : 51.8 4.3 mL O2/kg/min ) completed two trials , separated by 7 days , during which they ingested , in random order , 700 mL of either a 7 % CHO or placebo drink during a simulated soccer match .


Ratings of perceived exertion ( RPE ) , agility , timed and run to fatigue were measured during the trials .


Change in agility times was not altered by CHO vs. placebo ingestion ( 0.57 1.48 vs. 0.66 1.00 , p = 0.81 ) .


Timed runs to fatigue were 381 267 s vs. 294 159 s for the CHO and placebo drinks , respectively ( p = 0.11 ) .


Body mass modified the relationship between time to fatigue and drink ingestion ( p = 0.02 for drink body mass ) , such that lower body mass was associated with increased time to fatigue when the players ingested CHO , but not placebo .


RPE values for the final stage of the simulated soccer match were 8.5 1.7 and 8.6 1.5 for the CHO and placebo drinks respectively ( p = 0.87 ) .


The group data showed that the 7 % CHO solution ( 49 g CHO ) did not significantly improve performance during a simulated soccer match in league soccer players who had normal pre-match nutrition .


However , when adjusting for body mass , increasing CHO intake was associated with improved time to fatigue during the simulated soccer match .


To show the noninferiority of silodosin 8-mg once-daily ( QD ) to 4-mg twice-daily ( BID ) in efficacy and safety in patients with lower urinary tract symptoms or benign prostatic hyperplasia in the Korean population .


A prospective , multicenter , double-blind , randomized , comparative study was conducted .


A total of 532 male patients aged 50 years with lower urinary tract symptoms or benign prostatic hyperplasia were included .


All patients received silodosin QD or BID for 12 weeks .


The primary end point was the change from baseline in total International Prostate Symptom Score ( IPSS ) at 12 weeks .


Adverse drug reactions , vital signs , and laboratory tests were recorded .


A total of 424 patients were randomized to the silodosin QD or BID groups .


These groups were not significantly different in baseline characteristics .


The mean total IPSS change in QD group was not inferior to that in BID group ( -6.70 and -6.94 , respectively ; 95 % confidence interval , -0.88 to 1.36 ) .


The QD and BID groups did not significantly differ in the following : percentages of patients with 25 % ( 63.41 % and 67.82 % , respectively ; P = .349 ) or 4-point improvement in total IPSS ( 65.85 % and 69.31 % , respectively ; P = .457 ) , maximum urinary flow rate improvement 30 % ( 47.32 % and 40.59 % , respectively ; P = .172 ) , changes in IPSS voiding subscore ( -4.42 4.93 and -4.65 4.77 ; P = .641 ) , IPSS storage subscore ( -2.05 3.07 and -2.52 2.97 ; P = .117 ) , quality of life ( -1.19 1.49 and -1.40 1.42 ; P = .136 ) , maximum urinary flow rate ( 3.55 5.93 and 3.74 6.79 mL/s ; P = .768 ) , International Continence Society male questionnaire score , Patient Goal Achievement Score , or Treatment Satisfaction Question .


The 2 groups had similar frequencies of adverse drug reactions .


QD administration of silodosin was not inferior to BID in efficacy .


The 2 groups had similar adverse drug reaction profiles .


Analgesic and wound-healing effects of cinnamon , a widely used spice , have been shown in laboratory rats .


However , we found no human studies in this area .


The aim of this study was to assess the effect of cinnamon on perineal pain and healing of episiotomy incision .


In this double-blind , randomized , placebo-controlled trial , 144 postpartum women were allocated into two groups , using stratified block randomization , 1 h after completion of episiotomy repair .


They received cinnamon or placebo ointment , 2 mL every 12 h for 10 d.


Perineal pain and wound healing were assessed using visual analogue scale ( 0-10 ) and Redness , Edema , Ecchymosis , Discharge , Approximation scale ( 0-15 ) , respectively .


General linear model was used to compare the groups on the outcomes adjusted for baseline values and stratified factors .