Prenatal zinc or vitamin A supplementation demonstrates a small but significant effect on birth length , but supplementation with zinc , vitamin A or a combination of zinc and vitamin A , have no effect on birth weight , neonatal morbidity , or mortality .


Chikungunya is an emerging arthropod-borne disease that has spread from tropical endemic areas to more temperate climates of the USA and Europe .


However , no specific treatment or preventive measure is yet available .


We aimed to investigate the immunogenicity and safety of a live recombinant measles-virus-based chikungunya vaccine .


We did a randomised , double-blind , placebo-controlled , active-comparator , phase 1 , dose-escalation study at one centre in Vienna , Austria .


Healthy men and women aged 18-45 years with no comorbidities were randomly assigned , by computer-generated block randomisation ( block size of 14 ) , to receive either one of three escalating doses of the measles-virus-based candidate vaccine ( low dose [ 1510 ( 4 ) median tissue culture infection doses ( TCID50 ) per 005 mL ] , medium dose [ 7510 ( 4 ) TCID50 per 025 mL ] , or high dose [ 3010 ( 5 ) TCID50 per 10 mL ] ) , or the active comparator-Priorix .


Participants were additionally block-randomised to receive a booster injection on either day 28 or day 90 after the first vaccination .


Participants and study investigators were masked to group allocation .


The primary endpoint was the presence of neutralising anti-chikungunya antibodies on day 28 , as assessed by 50 % plaque reduction neutralisation test .


Analysis was by intention to treat and per protocol .


This trial is registered with EudraCT , number 2013-001084-23 .


Between Nov 22 , 2013 , and Feb 25 , 2014 , we randomly assigned 42 participants to receive the low dose ( n = 12 ) , the medium dose ( n = 12 ) , or the high dose ( n = 12 ) of the measles-virus-based candidate vaccine , or Priorix ( n = 6 ) , of whom 36 participants ( 86 % ; n = 9 , n = 12 , n = 10 , n = 5 , respectively ) were included in the per-protocol population .


The candidate vaccine raised neutralising antibodies in all dose cohorts after one immunisation , with seroconversion rates of 44 % ( n = 4 ) in the low-dose group , 92 % ( n = 11 ) in the medium-dose group , and 90 % ( n = 10 ) in the high-dose group .


The immunogenicity of the candidate vaccine was not affected by pre-existing anti-measles immunity .


The second vaccination resulted in a 100 % seroconversion for all participants in the candidate vaccine groups .


The candidate vaccine had an overall good safety profile , and the rate of adverse events increased with vaccine dose and volume .


No vaccination-related serious adverse events were recorded .


The live recombinant measles-virus-based chikungunya vaccine had good immunogenicity , even in the presence of anti-vector immunity , was safe , and had a generally acceptable tolerability profile .


This vaccine is the first promising measles-virus-based candidate vaccine for use in human beings .


Themis Bioscience GmBH .


Diabetes mellitus is an independent risk factor for cardiovascular disease .


To compare the efficacy of devices for continuous glucose monitoring and capillary glucose monitoring in hospitalized patients with acute coronary syndrome using the following parameters : time to achieve normoglycemia , period of time in normoglycemia , and episodes of hypoglycemia .


We performed a pilot , non-randomized , unblinded clinical trial that included 16 patients with acute coronary artery syndrome , a capillary or venous blood glucose 140 mg/dl , and treatment with a continuous infusion of fast acting human insulin .


These patients were randomized into 2 groups : a conventional group , in which capillary measurement and recording as well as insulin adjustment were made every 4h , and an intervention group , in which measurement and recording as well as insulin adjustment were made every hour with a subcutaneous continuous monitoring system .


Student 's t-test was applied for mean differences and the X ( 2 ) test for qualitative variables .


We observed a statistically significant difference in the mean time for achieving normoglycemia , favoring the conventional group with a P = 0.02 .


Continuous monitoring systems are as useful as capillary monitoring for achieving normoglycemia .


The use of a video-assisted laryngoscope ( VL ) has been shown to reduce the time to achieve intubation with a double-lumen endobronchial tube ( DLT ) .


As the blade of the VL is curved differently to a standard laryngoscope , the DLT must be angled into a hockey stick shape to fit properly .


We conducted a study to establish which direction of angulation was best to facilitate correct positioning of the DLT when using a VL .


We enrolled patients scheduled for thoracic surgery who required intubation with a DLT .


They were prospectively randomized into one of two groups : those intubated with a DLT angled to conceal the tracheal orifice ( the tracheal orifice-covered , TOC ) group or the tracheal orifice-exposed ( TOE ) group .


The composite primary outcome measures were time taken to intubate and the frequency of first-time success .


The time taken to intubate was divided into : T1 , the time from mouth opening to visualization of the vocal cords with the VL ; and T2 , the time taken to advance the DLT through the cords until its tip lay within the trachea and three carbon dioxide waveforms had been detected by capnography .


The hemodynamic responses to intubation and intubation-related adverse events were also recorded .


Sixty-six patients completed the study , with 33 in each group .


Total intubation time was significantly shorter in the TOC group ( mean 30.6 standard deviation 2.7 seconds versus 38.73.3 seconds , p < 0.0001 ) .


T2 was also significantly shorter in the TOC group than the TOE group ( 27.22.5 seconds versus 34.93.0 seconds , p < 0.0001 ) .


The severity of hoarseness on the first postoperative day and sore throat on the fourth postoperative day were significantly lower in the TOC group than the TOE group ( p = 0.02 and < 0.0001 , respectively ) .


The hemodynamic responses to intubation were broadly similar between the groups .


When placing a left-sided DLT using a VL , angling the bronchial lumen to a hockey stick shape that conceals the tracheal lumen saves time and ameliorates the severity of post-intubation complications .


ClinicalTrials.gov Identifier : NCT01605591 .


The aim of this study was to investigate the comparison of massage therapy and routine physical therapy on patients with sub acute and chronic nonspecific low back pain .


Thirty volunteer female subjects with a sub acute or chronic nonspecific low back pain were randomly enrolled in two groups , massage therapy and routine physical therapy .


After massage application , the hamstring and paravertebral muscles stretching and also stabilizing exercises were prescribed .


In the routine physical therapy group , TENS , US and vibrator were used besides exercises .


Pain intensity according to Numerical Rating Scale , functional disability level in accordance to Oswestry Disability Index , and modified Schober test , for measurement of flexion range of motion , before and after ten sessions of treatment were used to evaluate the effectiveness of the treatment .


Pain intensity , Oswestry Disability Index and flexion range of motion had shown significant differences before and after intervention in both groups ( p < 0.001 ) .


The statistical analysis revealed that the massage therapy had significantly improved the pain intensity and Oswestry Disability Index compared to routine physical therapy ( p = 0.015 , p = 0.013 respectively ) , but the range of motion changes were not significant between two groups ( p = 1.00 ) .


It can be concluded that both massage therapy and routine physical therapy are useful for sub acute and chronic nonspecific low back pain treatment especially if accompanied with exercise .


However , massage is more effective than other electrotherapy modalities , and it can be used alone or with electrotherapy for the treatment of patients with low back pain .


The aim of this study was to compare the efficacy and safety of once-weekly albiglutide with once-daily insulin glargine ( A21Gly , B31Arg , B32Arg human insulin ) in patients with type 2 diabetes inadequately controlled on metformin with or without sulfonylurea .


This was a randomised , open-label , multicentre ( n = 222 ) , parallel-group , non-inferiority out-patient clinical trial , with 779 patients enrolled in the study .


The study was conducted in 222 centres located in four countries .


Patients aged 18 years with type 2 diabetes treated with metformin ( sulfonylurea ) for at least 3 months with a baseline HbA1c 7.0-10 .0 % ( 53.0-85 .8 mmol/mol ) were randomly assigned ( 2:1 ) via a computer-generated randomisation sequence with a voice response system to receive albiglutide ( 30 mg once a week , n = 504 ) or insulin glargine ( 10 U once a day , n = 241 ) added to current therapy .


Participants and investigators were not masked to treatment assignment .


Doses of each medication were adjusted on the basis of the glycaemic response .


The primary endpoint was change from baseline in HbA1c at week 52 .


In the albiglutide group , HbA1c declined from 8.280.90 % ( 67.09.8 mmol/mol ) ( meanSD ) at baseline to 7.621.12 % ( 59.812.2 mmol/mol ) at week 52 .


A similar reduction occurred in the insulin glargine group ( 8.360.95 % to 7.551.04 % [ 67.910.4 to 59.011.4 mmol/mol ] ) .


The model-adjusted treatment difference of 0.11 % ( 95 % CI -0.04 % , 0.27 % ) ( 1.2 mmol/mol [ 95 % CI -0.4 , 3.0 mmol/mol ] ) indicated non-inferiority of albiglutide to insulin glargine based on the pre-specified non-inferiority margin of 0.3 % ( 3.3 mmol/mol , p = 0.0086 ) .


Body weight increased in the insulin glargine group and decreased in the albiglutide group , with a mean treatment difference of -2.61 kg ( 95 % CI -3.20 , -2.02 ; p < 0.0001 ) .


Documented symptomatic hypoglycaemia occurred in a higher proportion of patients in the insulin glargine group than in the albiglutide group ( 27.4 % vs 17.5 % , p = 0.0377 ) .


Albiglutide was non-inferior to insulin glargine at reducing HbA1c at week 52 , with modest weight loss and less hypoglycaemia .


Both drugs were well tolerated .


Albiglutide may be considered an alternative to insulin glargine in this patient population .


ClinicalTrials.gov NCT00838916 ( completed )


This study was planned and conducted by GlaxoSmithKline .


Cervical dilatation documented on partogram indicates expected rate of progress of labour and deviations from alert line indicates abnormal progress of labour .


Its early detection and timely intervention can reduce fetomaternal morbidity .


To study the role of partogram in the management of labouring mothers with high risk pregnancies at a tertiary care centre .


Four hundred primigravidas with high risk pregnancies in active labour ( with cervical dilatation 4 cm ) were studied , divided into two groups as Partogram and no Partogram group and each group consisted of 200 patients .


In Partogram group , progress of labour was documented on modified WHO partograph along with the notes on progress sheet of case record file while by standard notes only in no Partogram group .


Cases included were pregnancy-induced hypertension , gestational diabetes mellitus , cholestasis , hypothyroidism , history of previous one LSCS for trial of labour , postdated pregnancy .


Management of labour was standardised using set protocols of intrapartum care followed by analysis of duration of labour , rate of intervention , maternal and perinatal outcomes in both group .


Though percentage of normal vaginal delivery was higher in Partogram group ( 71.5 % ) than no Partogram group ( 68 % ) , no statistically significant difference was found between two groups regarding mean duration of active phase of first and second stage of labour , rate of operative vaginal deliveries ( partogram 12 % and no partogram 12.5 % ) and of caesarean section ( Partogram 16.5 % , no Partogram 18.5 % ) and perinatal outcome .


In this study , partogram had no significant impact on duration of labour , rate of operative interventions and perinatal outcome following its use in the labour management of high risk pregnancies .


To evaluate how soft lens power affects rigid gas-permeable ( RGP ) lens power and visual acuity ( VA ) in piggyback fittings for keratoconus .


Sixteen keratoconus subjects ( 30 eyes ) were included in the study .


Piggyback contact lens fittings combining Senofilcon-A soft lenses of -6.00 , -3.00 , +3.00 and +6.00 D with Rose K2 RGP contact lenses were performed .


Corneal topography was taken on the naked eye and over each soft contact lens before fitting RGP lenses .


Mean central keratometry , over-refraction , RGP back optic zone radius ( BOZR ) and estimated final power as well as VA were recorded and analyzed .


In comparison to the naked eye , the mean central keratometry flattened with both negative lens powers ( p < 0.05 in all cases ) , did not change with the +3.00 soft lens power ( p = 1.0 ) ; and steepened with the +6.00 soft lens power ( p = 0.02 ) .


Rigid gas-permeable over-refraction did not change significantly between different soft lens powers ( all p > 0.05 ) .


RGP 's BOZR decreased significantly with both positive in comparison with both negative soft lens powers ( all p < 0.001 ) , but no significant differences were found among negative - or positive-powers separately ( both p > 0.05 ) .


Estimated RGP 's final power increased significantly with positive in comparison with negative lens powers ( all p < 0.001 ) , but no significant differences were found among negative or positive lens powers separately ( both p > 0.05 ) .


Visual acuity did not change significantly between the different soft lens powers assessed ( all p > 0.05 ) .


The use of negative-powered soft lenses in piggyback fitting reduces RGP lens power without impacting VA in keratoconus subjects .


Leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity .


Weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints .


Brief interventions with simple behavior change messages are needed to reach high-risk children , particularly Latino and Black children who are disproportionately affected by obesity and related comorbidities .


Steps to Growing Up Healthy ( Added Value ) is a randomized controlled trial testing the efficacy of brief motivational counseling ( BMC ) delivered by primary care clinicians and the added value of supplementing BMC with monthly contact by community health workers ( CHW ) in the prevention/reversal of obesity in Latino and Black children ages 2-4years old .


Mother-child dyads ( targeted n = 150 ) are recruited for this 12-month randomized trial at an inner-city pediatric primary care clinic and randomized to : 1 ) BMC delivered by clinicians and nurses at well , sick , and WIC visits with the goal of reducing obesogenic behaviors ( BMC ) ; 2 ) BMC plus monthly phone calls by a CHW ( BMC+P hone ) ; or 3 ) BMC plus monthly home visits by a CHW ( BMC+H ome ) .


During BMC , the medical team facilitates the selection of a specific goal ( i.e. , reduce sugar sweetened beverage consumption ) that is meaningful to the mother and teaches the mother simple behavioral strategies .


Monthly contacts with CHWs are designed to identify and overcome barriers to goal progress .


Dyads are assessed at baseline and 12months and the primary outcome is change in the child 's BMI percentile .


We hypothesize that BMC+P hone and BMC+H ome will produce greater reductions in BMI percentiles than BMC alone and that BMC+H ome will produce greater reductions in BMI percentiles than BMC+P hone .


Steps to Growing Up Healthy will provide important information about whether a brief primary care-based intervention that utilizes a motivational interviewing and goal setting approach can be incorporated into routine care and is sufficient to prevent/reverse obesity in young children .


The study will also explore whether monthly contact with a community health worker bridges the gap between the clinic and the community and is an effective strategy for promoting obesity prevention in high-risk families .


ClinicalTrials.gov NCT01973153 .


To examine the associations between treatment/outcome expectations , alliance before and during treatment , and the impact of alliance on symptomatic improvement .


One hundred and fifty-three depressed patients randomized to dynamic supportive-expressive psychotherapy ( SET ) , antidepressant medication ( ADM ) or placebo ( PBO ) + clinical management completed ratings of treatment expectations , therapeutic alliance ( CALPAS , WAI-S ) , and depressive symptoms ( HAM-D ) .


Pretreatment expectations of the therapeutic alliance were significantly related to alliance later in therapy but did not differ across treatments and did not predict outcome .


Alliance development over time differed between treatments ; it increased more in SET than in PBO .


After controlling for prior symptom improvement , early alliance predicted subsequent depression change .


Expectations of alliance and of treatment outcome/improvement , measured prior to treatment onset , predicted subsequent alliance .


Successful implementation is a vital precondition for investigating the outcome of care innovation .


This study concerned the evaluation of the implementation of integrated emotion-oriented care ( IEOC ) in psychogeriatric nursing home wards .


The main question was whether the trained caregivers actually applied the knowledge and techniques of IEOC during their daily work .


The study was conducted within the framework of a randomized clinical trial into the effectiveness of IEOC in 16 wards .


Preceding the experimental period , staff from 16 wards were educated and trained to work with a standardized care plan , resulting in a similar level of quality of care at the start of the trial .


On the experimental wards IEOC was then implemented by training on the job in addition to training courses for personnel .


To examine the implementation effectiveness , a self-report questionnaire , 'Em otion-oriented Skills in the Interaction with Elderly People with Dementia ' , was administered at baseline and after 7 months to a sample of caregivers from the experimental and the control wards .


In addition , participant observation was conducted on four experimental and four control wards , and time spent by care personnel on different type of care tasks was registered .


The implementation of IEOC resulted in increased emotion-oriented skills and more knowledge of the residents among the caregivers .


Providing IEOC was not more time consuming for the caregivers than providing usual care .


This study shows that the implementation of IEOC was effective .


It is recommended that in intervention studies the correct application of a new intervention or care approach is examined before jumping to conclusions about the effectiveness of the intervention or care approach itself .


Randomized trials of complex , non-pharmacologic interventions implemented in home and community settings , such as the University of Southern California ( USC ) - Rancho Los Amigos National Rehabilitation Center ( RLANRC ) Pressure Ulcer Prevention Study ( PUPS ) , present unique challenges with respect to ( 1 ) participant recruitment and retention , ( 2 ) intervention delivery and fidelity , ( 3 ) randomization and assessment , and ( 4 ) potential inadvertent treatment effects .


We describe the methods employed to address the challenges confronted in implementing PUPS .


In this randomized controlled trial , we are assessing the efficacy of a complex , preventive intervention in reducing the incidence of , and costs associated with , the development of medically serious pressure ulcers in people with spinal cord injury .


Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group .


The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries , medical treatment costs , and quality of life .


These outcomes are assessed at 12 and 24 months after randomization .


Additionally , we are studying the mediating mechanisms that account for intervention outcomes .


PUPS has been successfully implemented , including recruitment of the target sample size of 170 participants , assurance of the integrity of intervention protocol delivery with an average 90 % treatment adherence rate , and enactment of the assessment plan .


However , implementation has been replete with challenges .


To meet recruitment goals , we instituted a five-pronged approach customized for an underserved , ethnically diverse population .


In intervention delivery , we increased staff time to overcome economic and cultural barriers to retention and adherence .


To ensure treatment fidelity and replicability , we monitored intervention protocol delivery in accordance with a rigorous plan .


Finally , we have overcome unanticipated assessment and design concerns related to ( 1 ) determining pressure ulcer incidence/severity , ( 2 ) randomization imbalance , and ( 3 ) inadvertent potential control group contamination .


We have addressed the most daunting challenges encountered in the recruitment , assessment , and intervention phases of PUPS .


Some challenges and solutions may not apply to trials conducted in other settings .


Overcoming challenges has required a multifaceted approach incorporating individualization , flexibility , and persistence , as well as the ability to implement needed mid-course corrections .


The therapeutic effects of antiretroviral treatment ( ART ) in patients with multidrug-resistant tuberculosis ( MDR-TB ) and human immunodeficiency virus ( HIV ) infection have not been established .


To assess therapeutic outcomes of integrating ART with treatment for MDR-TB .


A subgroup of MDR-TB patients from a randomised controlled trial , the SAPiT ( Starting Antiretroviral Therapy at Three Points in Tuberculosis ) study , conducted in an out-patient clinic in Durban , South Africa , from 2008 to 2012 .


Clinical outcomes at 18 months were compared in patients randomised to receive ART within 12 weeks of initiating standard first-line anti-tuberculosis treatment with those who commenced ART after completing anti-tuberculosis treatment .


Mycobacterium tuberculosis drug susceptibility results were available in 489 ( 76 % ) of 642 SAPiT patients : 23 had MDR-TB , 14 in the integrated treatment arm and 9 in the sequential treatment arm .


At 18 months , the mortality rate was 11.9 / 100 person-years ( py ; 95 % CI 1.4-42 .8 ) in the combined integrated treatment arm and 56.0 / 100 py ( 95 % CI 18.2-130 .8 ) in the sequential treatment arm ( hazard ratio adjusted for baseline CD4 count and whether MDR-TB treatment was initiated : 0.14 ; 95 % CI 0.02-0 .94 , P = 0.04 ) .


Despite the small sample size , the 86 % reduction in mortality due to early initiation of ART in MDR-TB patients was statistically significant .


To evaluate the effects of propofol , etomidate , and thiopental administered during phacoemulsification ( PE ) cataract extraction on intraocular pressure ( IOP ) and hemodynamic responses with insertion of laryngeal mask airway ( LMA ) .


In a randomized double-blind clinical trial , patients scheduled for PE with general anesthesia were included .


Patients were allocated randomly to 3 groups : group 1 ( n = 34 ) : 0.3 mg/kg etomidate ; group 2 ( n = 33 ) : 2mg/kg propofol ; and group 3 ( n = 34 ) : 4mg/kg thiopental .


IOP , systolic blood pressure , and heart rate ( HR ) were measured before induction as a baseline , 2min after induction ( immediately before insertion of LMA ) , and 1 and 3min after LMA insertion .


Blood pressure ( BP ) and HR of patients during the surgery were monitored and registered before and after induction and intubation .


In 3 groups , IOP decreased significantly after injection of drugs and insertion of LMA in comparison to basic values , although IOP after LMA insertion was more than before LMA insertion .


In case of propofol , the changes in IOP between 2min after induction and the baseline were higher than others , especially thiopental ( P = 0.031 ) .


BP declined remarkably after induction ( P < 0.001 ) and rose significantly after LMA insertion in all groups , except in the propofol group .


The HR was decreased significantly after induction , except in thiopental .


Propofol prevented IOP increase after induction compared with other drugs .


Decrease in BP and HR after induction and LMA insertion was remarkable .


Thiopental seemed to be the best drug for controlling cardiovascular parameters , especially HR , and it also prevents IOP rise .


Different drug combinations are used for sedation in colonoscopy procedures .


A ketamine-propofol ( ketofol ) mixture provides effective sedation and has minimal adverse effects .


Alfentanil also provides anesthesia for short surgical procedures by incremental injection as an adjunct .


However , no study has investigated the use of ketofol compared with an opioid-propofol combination in colonoscopic procedures .


A total of 70 patients , ASA physical status I-II , scheduled to undergo elective colonoscopy , were enrolled in this prospective randomized study and allocated to two groups .


After premedication , sedation induction was performed with 0.5 mg/kg ketamine +1 mg/kg propofol in Group KP , and 10 mg/kg alfentanil +1 mg/kg propofol in Group AP .


Propofol was added when required .


Demographic data , colonoscopy duration , recovery time , discharge time , mean arterial pressure ( MAP ) , heart rate ( HR ) , peripheral oxygen saturation , Ramsey Sedation Scale values , colonoscopy patients ' satisfaction scores , and complications were recorded .


The need for additional propofol doses was significantly higher in Group AP than in Group KP .


MAP at minute 1 and 5 , Ramsey Sedation Scale at minute 5 , and discharge time were significantly higher in Group KP than in Group AP .


Additional propofol doses and total propofol dose were significantly lower in Group KP than in Group AP .


Ketofol provided better hemodynamic stability and quality of sedation compared with alfentanil-propofol combination in elective colonoscopy , and required fewer additional propofol ; however , it prolonged discharge time .


Both combinations can safely be used in colonoscopy sedation .


Feasibility and efficacy of computerized auditory cognitive training ( ACT ) was examined among patients with heart failure ( HF ) .


Individuals with HF have four times increased risk of cognitive impairment , yet cognitive intervention studies are sparse .


A pilot randomized controlled design was used .


The ACT group ( n = 9 ) and control group ( n = 8 ) had similar baseline characteristics .


Seven participants ( 78 % ) completed 18 hours of ACT .


Medium effect sizes were observed for improved cognition as indicated by auditory processing speed ( d = 0.78 ) , speech processing ( d = 0.88 ) , and working memory ( d = 0.44-0 .50 ) .


Small effect sizes were found for improved functional outcomes including HF selfcare ( d = 0.34 ) , Timed Instrumental Activities of Daily Living ( d = 0.32 ) , Six-Minute Walk Test ( d = 0.38 ) and Short-Form-36 ( d = 0.22 ) relative to controls .


Results indicated ACT is feasible among persons with HF .


Despite a small sample size , ACT showed potential for improved speed of processing and working memory and improved functional outcomes , and warrants further exploration .


Impulse control disorders ( ICDs ) in Parkinson disease ( PD ) are common and can be difficult to manage .


The objective of this study was to determine the efficacy and tolerability of naltrexone , an opioid antagonist , for the treatment of ICDs in PD .


Patients with PD ( n = 50 ) and an ICD were enrolled in an 8-week , randomized ( 1:1 ) , double-blind , placebo-controlled study of naltrexone 50-100 mg/d ( flexible dosing ) .


The primary outcome measure was response based on the Clinical Global Impression-Change score , and the secondary outcome measure was change in symptom severity using the Questionnaire for Impulsive-Compulsive Disorders in Parkinson 's Disease-Rating Scale ( QUIP-RS ) ICD score .


Forty-five patients ( 90 % ) completed the study .


The Clinical Global Impression-Change response rate difference favoring naltrexone in completers was 19.8 % ( 95 % confidence interval [ CI ] -8.7 % to 44.2 % ) .


While this difference was not significant ( odds ratio = 1.6 , 95 % CI 0.5-5 .2 , Wald 2 [ df ] = 0.5 [ 1 ] , p = 0.5 ) , naltrexone treatment led to a significantly greater decrease in QUIP-RS ICD score over time compared with placebo ( regression coefficient for interaction term in linear mixed-effects model = -7.37 , F [ df ] = 4.3 [ 1 , 49 ] , p = 0.04 ) .


The estimated changes in QUIP-RS ICD scores from baseline to week 8 were 14.9 points ( 95 % CI 9.9-19 .9 ) for naltrexone and 7.5 points ( 95 % CI 2.5-12 .6 ) for placebo .


Naltrexone treatment was not efficacious for the treatment of ICDs in PD using a global assessment of response , but findings using a PD-specific ICD rating scale support further evaluation of opioid antagonists for the treatment of ICD symptoms in PD .


This study provides Class I evidence that in patients with PD and an ICD , naltrexone does not significantly increase the probability of achieving response .


However , the study lacked the precision to exclude an important difference in response rates .


Elevated low-density lipoprotein cholesterol ( LDL-C ) is a major modifiable risk factor for cardiovascular disease ( CVD ) , a leading cause of death in the United States .


Despite clinical practice guidelines aimed at facilitating LDL-C control , many Veterans do not achieve guideline-recommended LDL-C levels .


We describe a study focused on VA healthcare system users at risk for CVD ( i.e. , LDL-C level > 130 mg/dl and/or < 80 % cholesterol pill refill adherence in the last 12 months ) .


We are conducting a two and a half year randomized controlled trial ( i.e. , intervention administered over 12 months ) among Veterans with uncontrolled cholesterol receiving care at select VA-affiliated primary care clinics in North Carolina .


We anticipate enrolling 250 diverse patients ( 10 % women ; 40 % African American ) .


Patients are randomized to an educational control group or intervention group .


Intervention group participants ' medication is provided in special blister packaging labeled for daily use that includes reminders ; MeadWestvaco Corporation 's pre-filled DosePak contains standard doses of statins in accordance with the existing prescriptions .


Pre-filled blister packaging may provide an inexpensive solution to improve medication adherence .


Our study enrolls a diverse sample and provides information about whether an adherence packaging intervention can : 1 ) improve medication adherence ; 2 ) improve patients ' LDL-C levels ; 3 ) be well received by patients and providers ; and 4 ) provide a cost effective solution to improve medication adherence .


One third of patients with triple-negative breast cancer ( TNBC ) achieve pathologic complete response ( pCR ) with standard neoadjuvant chemotherapy ( NACT ) .


CALGB 40603 ( Alliance ) , a 2 2 factorial , open-label , randomized phase II trial , evaluated the impact of adding carboplatin and/or bevacizumab .


Patients ( N = 443 ) with stage II to III TNBC received paclitaxel 80 mg/m ( 2 ) once per week ( wP ) for 12 weeks , followed by doxorubicin plus cyclophosphamide once every 2 weeks ( ddAC ) for four cycles , and were randomly assigned to concurrent carboplatin ( area under curve 6 ) once every 3 weeks for four cycles and/or bevacizumab 10 mg/kg once every 2 weeks for nine cycles .


Effects of adding these agents on pCR breast ( ypT0/is ) , pCR breast/axilla ( ypT0/isN0 ) , treatment delivery , and toxicities were analyzed .


Patients assigned to either carboplatin or bevacizumab were less likely to complete wP and ddAC without skipped doses , dose modification , or early discontinuation resulting from toxicity .


Grade 3 neutropenia and thrombocytopenia were more common with carboplatin , as were hypertension , infection , thromboembolic events , bleeding , and postoperative complications with bevacizumab .


Employing one-sided P values , addition of either carboplatin ( 60 % v 44 % ; P = .0018 ) or bevacizumab ( 59 % v 48 % ; P = .0089 ) significantly increased pCR breast , whereas only carboplatin ( 54 % v 41 % ; P = .0029 ) significantly raised pCR breast/axilla .


More-than-additive interactions between the two agents could not be demonstrated .


In stage II to III TNBC , addition of either carboplatin or bevacizumab to NACT increased pCR rates , but whether this will improve relapse-free or overall survival is unknown .


Given results from recently reported adjuvant trials , further investigation of bevacizumab in this setting is unlikely , but the role of carboplatin could be evaluated in definitive studies , ideally limited to biologically defined patient subsets most likely to benefit from this agent .


Impaired regulation of lipid oxidation ( metabolic inflexibility ) is associated with obesity and type 2 diabetes mellitus .


Recent evidence has indicated that dietary polyphenols may modulate mitochondrial function , substrate metabolism and energy expenditure in humans .


The present study investigated the effects of short-term supplementation of two combinations of polyphenols on energy expenditure ( EE ) and substrate metabolism in overweight subjects .


Eighteen healthy overweight volunteers ( 9 women , 9 men ; age 352.5 years ; body mass index 28.90.4 kgm ( -2 ) ) participated in a randomized , double-blind cross-over trial .


Combinations of epigallocatechin-gallate ( E , 282mgday ( -1 ) ) + resveratrol ( R , 200mgday ( -1 ) ) and E+R +80 mgday ( -1 ) soy isoflavones ( S ) or placebo capsules ( PLA ) were supplemented twice daily for a period of 3 days .


On day 3 , circulating metabolite concentrations , EE and substrate oxidation ( using indirect calorimetry ) were measured during fasting and postprandial conditions for 6h ( high-fat-mixed meal ( 2.6 MJ , 61.2 E % fat ) ) .


Short-term supplementation of E+R increased resting EE ( E+R vs PLA : 5.450.24 vs 5.230.25 kJmin ( -1 ) , P = 0.039 ) , whereas both E+R ( 69918kJ120min ( -1 ) vs 67620kJ120min ( -1 ) , P = 0.028 ) and E+R+S ( 70418kJ120min ( -1 ) vs 67620kJ120min ( -1 ) , P = 0.014 ) increased 2-4h-postprandial EE compared with PLA .


Metabolic flexibility , calculated as the postprandial increase to the highest respiratory quotient achieved , tended to be improved by E+R compared with PLA and E+R+S only in men ( E+R vs PLA : 0.110.02 vs 0.060.02 , P = 0.059 ; E+R+S : 0.030.02 , P = 0.009 ) .


E+R+S significantly increased fasting plasma free fatty acid ( P = 0.064 ) and glycerol ( P = 0.021 ) concentrations compared with PLA .


We demonstrated for the first time that combined E+R supplementation for 3 days significantly increased fasting and postprandial EE , which was accompanied by improved metabolic flexibility in men but not in women .


Addition of soy isoflavones partially reversed these effects possibly due to their higher lipolytic potential .


The present findings may imply that long-term supplementation of these dosages of epigallocatechin-gallate combined with resveratrol may improve metabolic health and body weight regulation .


Acute pancreatitis ( AP ) is a disease typically requiring in-hospital treatment .


We conducted a trial to assess the feasibility of early discharge from the hospital for patients with mild non-alcoholic acute pancreatitis ( NAAP ) .


Eighty-four patients with mild NAAP were randomized to home or hospital groups after a short hospital stay ( 24h ) .


AP was defined by the revised Atlanta criteria .


Mild AP was defined as an Imrie score5 and a harmless acute pancreatitis score ( HAPS ) 2 in the first 24-h of presentation .


A nurse visited all patients in the home group on the 2nd , 3rd and 5th days .


All patients presented for follow-up in clinic on the 7th , 14th , and 30th days .


The primary outcome was the time to resolution of pain .


Secondary outcomes evaluated included time to resumption of an oral diet , 30 day hospital readmission rate as well as the total costs associated with either approach to care .


There was no difference between the groups with regards to demographics , prognostic severity scores , symptoms , and biliary findings .


No patients developed organ failure , pancreatic necrosis , or died in either group .


Time to the resolution of pain and resumption of solid food intake were similar .


Three ( 3.6 % ) patients required readmission within 30 days , 1 from home and 2 from the hospital groups .


The total cost was significantly less in home group ( $ 13973 vs. $ 951715 , p < 0.001 ) .


Mild NAAP can be safely treated at home with regular visits by a nurse under the supervision of a physician .


Widespread adoption of this practice may result in large cost savings .


Clopidogrel plays a central role in the treatment of patients undergoing carotid artery stenting ( CAS ) .


The objective was to evaluate the effect of clopidogrel ( 75 mg/d ) on platelet reactivity in responders and nonresponders and the antiplatelet effect of different doses of clopidogrel in patients with high on-treatment reactivity ( OTR ) after CAS .


Patients with high OTR ( defined by VerifyNow ( Accumetrics , San Diego , Calif ) assay as 230 P2Y12 reaction units [ PRU ] ) were randomly assigned in a 1:1 ratio to group 1 ( standard-dose clopidogrel therapy : 75 mg/d for 30 days ) or group 2 ( high-dose clopidogrel : 150 mg/d for 30 days ) .


The study enrolled 214 patients .


Of these , 115 ( 53.7 % ) were clopidogrel responders ( group 0 ) , and 99 ( 46.3 % ) had high OTR ( clopidogrel nonresponders ) ; of which , 50 were randomly assigned to group 1 and 49 to group 2 .


At baseline , the PRU value did not differ between group 1 ( 288.50 46 ) and group 2 ( 295.45 47.2 ; P = .308 ) .


Patients displayed reduced mean platelet reactivity levels at 30 days in group 1 ( 238.96 72.25 ; P < .001 ) and group 2 ( 201.85 77.8 ; P < .001 ) .


Although high-dose clopidogrel resulted in more intense platelet function inhibition , the differences between median 30-day PRU values ( P = .483 ) and the percentage change of PRU ( P = .442 ) for groups 1 and 2 were not significant .


The incidences of transient ischemic attack , stroke , or death at up to 30 days after CAS in the high-OTR patients were similar between groups 1 and 2 ( P = .481 ) .


Patients with high OTR undergoing CAS treated with standard-dose and double-dose clopidogrel had significantly reduced platelet reactivity after 30 days .


The double dose did not result in statistically significantly greater reductions in reactivity compared with the standard dose .


Home-based exercise training in cardiac rehabilitation ( CR ) has the potential to improve CR uptake , decrease costs and increase self-management skills .


The FIT@Home study evaluates home-based CR with telemonitoring guidance using coaching interventions including strategies for behavioural changes with the aim to maintain adherence to a healthy lifestyle and to improve long-term effects .


In this interim analysis we provide short-term results on exercise capacity , quality of life and training adherence of the first 50 patients included in the FIT@Home study .


The study design was a randomised controlled trial .


Low to moderate risk CR patients were randomised to a 12-week home-based training ( HT ) programme or a 12-week centre-based training ( CT ) programme .


In both groups , training was performed at 70-85 % of maximal heart rate ( HRmax ) for 45-60min , 2-3 times per week .


The HT group received three supervised training sessions , before commencing training with a heart rate monitor in their home environment .


These patients received individual coaching by telephone weekly , based on training data uploaded on the Internet .


The CT programme was performed under the direct supervision of a physical therapist .


Exercise capacity and health-related quality of life were assessed at baseline and at 12 weeks .


CT ( n = 25 ) and HT ( n = 25 ) both showed a significant improvement in peak oxygen uptake ( peak VO2 ) ( 10 % and 14 % respectively ) and quality of life after 12 weeks of training , without significant between-group differences .


The average training intensity of the HT group was 73.33.5 % of HRmax .


Training adherence was similar between groups .


This analysis shows that HT with telemonitoring guidance has similar short-term effects on exercise capacity and quality of life as CT in CR patients .


Both exposure to hypoxia and exercise training have the potential to modulate appetite and induce beneficial metabolic adaptations .


The purpose of this study was to determine whether daily moderate exercise training performed during a 10-day exposure to normobaric hypoxia alters hormonal appetite regulation and augments metabolic health .


Fourteen healthy , male participants underwent a 10-day hypoxic confinement at 4000 m simulated altitude ( FIO2 = 0.139 0.003 % ) either combined with daily moderate intensity exercise ( Exercise group ; N = 8 , Age = 25.8 2.4 yrs , BMI = 22.9 1.2 kg m ( -2 ) ) or without any exercise ( Sedentary group ; N = 6 Age = 24.8 3.1 yrs , BMI = 22.3 2.5 kg m ( -2 ) ) .


A meal tolerance test was performed before ( Pre ) and after the confinement ( Post ) to quantify fasting and postp randial concentrations of selected appetite-related hormones and metabolic risk markers .


13C-Glucose was dissolved in the test meal and 13CO2 determined in breath samples .


Perceived appetite ratings were obtained throughout the meal tolerance tests .


While body mass decreased in both groups ( -1.4 kg ; p = 0.01 ) following the confinement , whole body fat mass was only reduced in the Exercise group ( -1.5 kg ; p = 0.01 ) .


At Post , postprandial serum insulin was reduced in the Sedentary group ( -49 % ; p = 0.01 ) and postprandial plasma glucose in the Exercise group ( -19 % ; p = 0.03 ) .


Fasting serum total cholesterol levels were reduced ( -12 % ; p = 0.01 ) at Post in the Exercise group only , secondary to low-density lipoprotein cholesterol reduction ( -16 % ; p = 0.01 ) .


No differences between groups or testing periods were noted in fasting and/or postprandial concentrations of total ghrelin , peptide YY , and glucagon-like peptide-1 , leptin , adiponectin , expired 13CO2 as well as perceived appetite ratings ( p > 0.05 ) .


These findings suggest that performing daily moderate intensity exercise training during continuous hypoxic exposure does not alter hormonal appetite regulation but can improve the lipid profile in healthy young males .


The use of Web-based apps to promote a healthy lifestyle is increasing , although most of these programs were not assessed using suitable epidemiological methods .


We evaluated the effectiveness of a newly developed Web-based app in promoting a healthy lifestyle and educating adults on such lifestyles .


We also analyzed predictors for success in acquiring and maintaining a healthy lifestyle .


Our aim was to compare people receiving a new Web-based app with people who got an introductory lecture alone on healthy lifestyle , weight change , nutritional knowledge , and physical activity , and to identify predictors of success for maintaining a healthy lifestyle .


Subjects were recruited from the community and were randomized into intervention and control groups .


The intervention subjects received access to the app without any face-to-face support ; the control subjects continued their standard lifestyle .


Measurements were taken by the researcher at baseline and after 14 weeks and included weight and waist circumference .


Nutritional knowledge , diet quality , and physical activity duration were obtained using online questionnaires .


The new Web-based app was developed based on current US Department of Agriculture and Israel Ministry of Health recommendations for healthy lifestyle .


The app provides tools for monitoring diet and physical activity while instructing and encouraging healthy diet and physical activity .


Out of 99 subjects who were randomized into app and control groups , 85 participants ( 86 % ) completed the study , 56 in the intervention and 29 in the control group .


The mean age was 47.9 ( SD 12.3 ) years , and mean Body Mass Index was 26.2 ( SD 3.9 ) .


Among the intervention group only , frequency of app use was 2.7 ( SD 1.9 ) days/week .


The mean change in physical activity was 63 ( SD 20.8 ) minutes in the app group and -30 ( SD 27.5 ) minutes in the control group ( P = .02 ) .


The mean weight change was -1.44 ( SD 0.4 ) kg in the app group and -0.128 ( SD 0.36 ) kg in the control group ( P = .03 ) .


Knowledge score increased significantly in the app group , 76 ( SD 7.5 ) to 79 ( SD 8.7 ) at the end of the study ( P = .04 ) compared with the control group .


Diet quality score also increased significantly at the end of the study , from 67 ( SD 9.8 ) to 71 ( SD 7.6 ; P < .001 ) in contrast to the control group .


Success score ( represents the success in maintaining healthy lifestyle ) was higher among the app group ( 68 % ) compared with 36 % in the control group ( P < .001 ) .


The app frequency of use was significantly related to a higher success score ( P < .001 ) .


We showed a positive impact of a newly developed Web-based app on lifestyle indicators during an intervention of 14 weeks .


These results are promising in the app 's potential to promote a healthy lifestyle , although larger and longer duration studies are needed to achieve more definitive conclusions .


Clinicaltrial.gov number : NCT01913496 ; http://www.clinicaltrials.gov/ct2/show/NCT01913496 ( Archived by WebCite at http://www.webcitation.org/6WSTUEPuJ ) .


Peroral endoscopic myotomy ( POEM ) has recently been introduced as a promising alternative to laparoscopic Heller myotomy for idiopathic achalasia .


Several proposed technical modifications are yet to be tested in randomized trials .


The objective of our study was to evaluate efficacy and safety of water-jet ( WJ ) assisted POEM versus the conventional ( C ) technique .


The clinical trial registration number is NCT01742494 .


A prospective randomized trial was carried out in Zhongshan Hospital , Fudan University ( Shanghai , China ) , in 100 consenting achalasia patients between August 2011 and April 2012 .


Patients eligible for POEM were randomized to use of either the HybridKnife ( WJ group ) or the conventional technique using injection and triangle tip knife interchangeably ( C group ) .


A total of 100 patients with comparable characteristics between groups were included .


Procedure time was significantly shorter for the WJ group ( 22.9 6.7 vs. 35.9 11.7 min ; p < 0.0001 ) , mostly due to less replacement of accessories ( 2.0 2.4 vs. 19.2 7.6 ; p < 0.0001 ) .


Injection volume was larger in the WJ group ( 45.3 10.2 vs. 35.2 9.5 ml ; p < 0.0001 ) and was associated with fewer minor bleeding episodes ( 3.6 1.8 vs. 6.8 5.2 ; p < 0.0001 ) .


No severe complications occurred ; one case of cutaneous emphysema occurred in the WJ group , and four cases occurred in the C group ( p = 0.17 ) , three cases of pneumonia were encountered in the C group and none in the WJ group ( p = 0.24 ) .


Treatment success ( Eckardt score 3 ) was achieved in 96.5 % of patients , with no significant differences between groups .


The use of the HybridKnife leads to a significant decrease in POEM procedure time and facilitates reinjection , possibly contributing to a lower rate of minor intra-procedural bleeding .


The aim of the present study was to determine whether specific biochemical and energy concentrations influence gastric emptying of unfortified and fortified mother 's own milk ( MOM ) in stable preterm infants , and whether gastric emptying differs between feeds of unfortified MOM and feeds fortified with S-26 or FM 85 human milk fortifier ( HMF ) when infants are fed the same volume under similar conditions .


Influences of infant gestation , age , and weight , and feed characteristics were also explored .


Stomach volumes of 25 paired unfortified and fortified MOM feeds were monitored prefeed and postfeed delivery and at 30-minute intervals thereafter .


For each feed , MOM samples were analyzed to determine concentrations of total protein , casein , whey , carbohydrate , lactose , fat , and energy .


Fortified feed compositions were calculated by adding fortifier biochemical and energy concentrations to unfortified MOM concentrations .


Ultrasound images were used to calculate infant stomach volumes .


Statistical comparisons were made of paired stomach volume measurements .


Higher feed concentrations of casein were associated with faster gastric emptying during feed delivery ( P = 0.007 ) .


When compared with unfortified MOM , S-26 fortified feeds emptied similarly , whereas FM 85 fortified feeds emptied more slowly both during feed delivery and during the postprandial period ( P = 0.002 , < 0.001 , respectively ) .


Gastric emptying was slower for 2-hourly feeds compared with that for 3-hourly feeds ( P = 0.003 ) and in supine position compared with that in prone ( P = 0.001 ) .


Breast milk composition influences gastric emptying in stable preterm infants , with feeds of higher casein concentration emptying faster during feeding than otherwise equivalent feeds , and FM 85 fortified MOM emptying more slowly than unfortified MOM .


Newly emerging evidence showed that glucocorticoids could potentiate natriuretic peptides ' action by increasing the density of natriuretic peptide receptor A , leading to a potent diuresis and a renal function improvement in patients with acute decompensated heart failure ( ADHF ) .


Therefore , glucocorticoid therapy may be used in patients with ADHF .


One hundred two patients with ADHF were randomized to receive glucocorticoids or standard treatment .


Change from baseline in serum creatinine ( SCr ) at day 7 and cardiovascular death within 30 days were recorded .


The study was terminated early because of slow site initiation and patient enrolment .


Glucocorticoid therapy seemed to be well tolerated .


There was a remarkable SCr reduction after 7 days treatment .


The change from baseline in SCr is -0.14 mg/dL in glucocorticoid group versus -0.02 mg/dL in standard treatment group ( P < 0.05 ) .


Although sample size is limited , a cardiovascular death reduction at 30 days was observed in glucocorticoid group with odds ratio of 0.26 ( 3 deaths in glucocorticoid vs. 10 deaths in standard treatment group , P < 0.05 ) .


The survival benefit associated with glucocorticoid therapy persisted during the follow-up .


Patient-assessed dyspnea and physician-assessed global clinical status were also improved in glucocorticoid group .


Limited data indicate that glucocorticoid therapy may be used safely in patients with ADHF in short term .


Glucocorticoid therapy did not cause heart failure deterioration .


Further investigations are warranted .


Hip fractures are a common type of fragility fracture that afflict 293,000 Americans ( over 5,000 per week ) and 35,000 Canadians ( over 670 per week ) annually .


Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial .


The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures .


The secondary objective is to determine the impact on health-related quality of life , functional outcomes , health state utilities , fracture healing , mortality and fracture-related adverse events .


FAITH is a multi-centre , multi-national randomized controlled trial utilizing minimization to determine patient allocation .


Surgeons in North America , Europe , Australia , and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures .


Using central randomization , patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw .


Patient outcomes will be assessed at one week ( baseline ) , 10 weeks , 6 , 12 , 18 , and 24 months post initial fixation .


We will independently adjudicate revision surgery and complications within 24 months of the initial fixation .


Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test .


This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures .


This trial will not only change current Orthopaedic practice , but will also set a benchmark for the conduct of future Orthopaedic trials .


The FAITH trial is registered at ClinicalTrials.gov ( Identifier NCT00761813 ) .


Compare mechanical and pharmacological ripening for patients with oligohydramnios at term .


Fifty-two patients with oligohydramnios 5 cm and Bishop score 6 were randomized for labor induction with a vaginal insert containing 10 mg timed-release dinoprostone ( PGE2 ) or double-balloon catheter .


The primary outcome was time from induction to active labor .


Time to labor , neonatal outcomes and maternal satisfaction were also compared .


Baseline characteristics were similar .


Time from induction to active labor ( 13 with PGE2 vs 19.5 h with double-balloon catheter ; P = 0.243 ) was comparable , with no differences in cesarean rates ( 15.4 vs 7.7 % ; P = 0.668 ) or neonatal outcomes .


The PGE2 group had higher incidence of early device removal ( 76.9 vs 26.9 % ; P = 0.0001 ) , mostly because of active labor or non-reassuring fetal heart rate .


Fewer PGE2 patients required oxytocin augmentation for labor induction ( 53.8 vs 84.6 % P = 0.034 ) .


Time to delivery was significantly shorter with PGE2 ( 16 vs 20.5 h ; P = 0.045 ) .


Intravaginal PGE2 and double-balloon catheter are comparable methods for cervical ripening in term pregnancies with oligohydramnios .


To explore the efficacy and safety of remifentanyl and propofol injection in total intravenous anesthesia for percutaneous radiofrequency ablation .


60 patients scheduled for PRFA were divided randomly into two groups : group A and group B. Each group contained 30 patients .


Those in group A received remifentanyl and propofol injection , and the patients in group B were given oxycodone hydrochloride .


The mean arterial pressure ( MAP ) , heart rate ( HR ) and pulse oxygen saturation ( SPO2 ) were measured and recorded by monitor during the operation .


The chest muscle rigidity , respiratory depression , nausea and vomitting , hypotensio and VAS were also recorded .


Compared with the preoperative , MAP , HR in group A decreased significantly during the operation , increased in group B ( P < 0.05 ) .


VAS was significantly lower in group A than that in group B ( P < 0.05 ) .


2 patients had respiratory depression , 1 patient had nausea and vomiting reaction in group A. 2 patients had vagus reflex , 3 patient had nausea and vomitting reaction in group B.


Total intravenous anesthesia with remifentanyl and propofol for PRFA is safe and reliable .


Respiratory and circulation should be monitored instantly and strictly .


NOX-2 , the catalytic subunit of NADPH oxidase , has a key role in the formation of reactive oxidant species and is implicated in impairing flow-mediated dilation ( FMD ) .


Dark chocolate exerts artery dilatation via down-regulating NOX2-mediated oxidative stress .


The aim of this study was to investigate whether dark chocolate improves walking autonomy in peripheral artery disease ( PAD ) patients via an oxidative stress-mediated mechanism .


FMD , serum levels of isoprostanes , nitrite/nitrate ( NOx ) and sNOX2-dp , a marker of blood NOX2 activity , maximal walking distance ( MWD ) and maximal walking time ( MWT ) were studied in 20 PAD patients ( 14 males and 6 females , mean age : 699 years ) randomly allocated to 40 g of dark chocolate ( > 85 % cocoa ) or 40 g of milk chocolate ( 35 % cocoa ) in a single blind , cross-over design .


The above variables were assessed at baseline and 2 hours after chocolate ingestion .


Dark chocolate intake significantly increased MWD ( +11 % ; P < 0.001 ) , MWT ( +15 % ; P < 0.001 ) , serum NOx ( +57 % ; P < 0.001 ) and decreased serum isoprostanes ( -23 % ; P = 0.01 ) and sNOX2-dp ( -37 % ; P < 0.001 ) ; no changes of the above variables were observed after milk chocolate intake .


Serum epicatechin and its methylated metabolite significantly increased only after dark chocolate ingestion .


Multiple linear regression analysis showed that of MWD was independently associated with of MWT ( P < 0.001 ) and of NOx ( P = 0.018 ) .


In vitro study demonstrated that HUVEC incubated with a mixture of polyphenols significantly increased nitric oxide ( P < 0.001 ) and decreased E-selectin ( P < 0.001 ) and VCAM1 ( P < 0.001 ) .


In PAD patients dark but not milk chocolate acutely improves walking autonomy with a mechanism possibly related to an oxidative stress-mediated mechanism involving NOX2 regulation .


http://www.clinicaltrials.gov .


Unique identifier : NCT01947712 .


BK virus infection is a significant complication of modern immunosuppression used in kidney transplantation .


Viral reactivation occurs first in the urine ( BK viruria ) and is associated with a high risk of transplant failure .


There are currently no therapies to prevent or treat BK virus infection .


Quinolone antibiotics have antiviral properties against BK virus but efficacy at preventing this infection has not been shown in prospective controlled studies .


To determine if levofloxacin can prevent BK viruria in kidney transplant recipients .


Double-blind , placebo-controlled randomized trial involving 154 patients who received a living or deceased donor kidney-only transplant in 7 Canadian transplant centers between December 2011 and June 2013 .


Participants were randomly assigned to receive a 3-month course of levofloxacin ( 500 mg/d ; n = 76 ) or placebo ( n = 78 ) starting within 5 days after transplantation .


The primary outcome was time to occurrence of BK viruria ( detected using quantitative real-time polymerase chain reaction ) within the first year after transplantation .


Secondary outcomes included BK viremia , peak viral load , rejection , and patient and allograft survival .


The mean follow-up time was 46.5 weeks in the levofloxacin group and 46.3 weeks in the placebo group ( 27 patients had follow-up terminated before the end of the planned follow-up period or development of viruria because the trial was stopped early owing to lack of funding ) .


BK viruria occurred in 22 patients ( 29 % ) in the levofloxacin group and in 26 patients ( 33.3 % ) in the placebo group ( hazard ratio , 0.91 ; 95 % CI , 0.51-1 .63 ; P = .58 ) .


There was no significant difference between the 2 groups in regard to any of the secondary end points .


There was an increased risk of resistant infection among isolates usually sensitive to quinolones in the levofloxacin group vs placebo ( 14/24 [ 58.3 % ] vs 15/45 [ 33.3 % ] , respectively ; risk ratio , 1.75 ; 95 % CI , 1.01-2 .98 ) as well as a nonsignificant increased risk of suspected tendinitis ( 6/76 [ 7.9 % ] vs 1/78 [ 1.3 % ] ; risk ratio , 6.16 ; 95 % CI , 0.76-49 .95 ) .


Among kidney transplant recipients , a 3-month course of levofloxacin initiated early following transplantation did not prevent BK viruria .


Levofloxacin was associated with an increased risk of adverse events such as bacterial resistance .


These findings do not support the use of levofloxacin to prevent posttransplant BK virus infection .


clinicaltrials.gov Identifier : NCT01353339 .


In myocardial perfusion single-photon emission computed tomography ( SPECT ) , abdominal activity often interferes with the evaluation of perfusion in the inferior wall , especially after pharmacological stress .


In this randomized study , we examined the effect of carbonated water intake versus still water intake on the quality of images obtained during myocardial perfusion images ( MPI ) studies .


A total of 467 MIBI studies were randomized into a carbonated water group and a water group .


The presence of intestinal activity adjacent to the inferior wall was evaluated by two observers .


Furthermore , a semi-quantitative analysis was performed in the adenosine subgroup , using a count ratio of the inferior myocardial wall and adjacent abdominal activity .


The need for repeated SPECT in the adenosine studies was 5.3 % in the carbonated water group versus 19.4 % in the still water group ( p = 0.019 ) .


The inferior wall-to-abdomen count ratio was significantly higher in the carbonated water group compared to the still water group ( 2.11 1.00 vs. 1.72 0.73 , p < 0.001 ) .


The effect of carbonated water during rest and after exercise was not significant .


This randomized study showed that carbonated water significantly reduced the interference of extra-cardiac activity in adenosine SPECT MPI .


A hernia repair open surgical simulation computer software was developed at Imperial College London .


A randomized controlled educational trial was conducted to investigate the benefit of the simulation on the development of procedural knowledge .


Medical students in their clinical years were invited to participate in the trial .


Students were block randomized to 4 groups : G1 -- Interactive Simulation ; G2 -- Non-interactive Simulation ; G3 -- Video Tutorial ; G4 -- Control .


On completion , they were objectively assessed on their ability to recall the tasks involved in an open inguinal hernia repair in the form of a multiple choice question ( MCQ ) and a simulated discussion with a consultant surgeon .


Fifty-six students completed the study .


Each arm carries similar baseline scores ( pre-intervention MCQ ) with means 43.33 , 38.92 , 38.33 , and 39.57 in G1 to G4 , respectively .


MCQ score improvements and final assessment scores proved better in the intervention groups ( 1 , 2 , and 3 ) compared to controls .


The interactive simulation has shown an objective benefit in teaching medical students the anatomical and procedural knowledge in performing an open inguinal hernia repair .


Given the substantial improvements in cancer screening and cancer treatment in the United States , millions of adult cancer survivors live for years following their initial cancer diagnosis and treatment .


However , latent side effects can occur and some symptoms can be alleviated or managed effectively via changes in lifestyle behaviors .


The purpose of this study was to test the effectiveness of a six-week Web-based multiple health behavior change program for adult survivors .


Participants ( n = 352 ) were recruited from oncology clinics , a tumor registry , as well as through online mechanisms , such as Facebook and the Association of Cancer Online Resources ( ACOR ) .


Cancer survivors were eligible if they had completed their primary cancer treatment from 4 weeks to 5 years before enrollment .


Participants were randomly assigned to the Web-based program or a delayed-treatment control condition .


In total , 303 survivors completed the follow-up survey ( six months after completion of the baseline survey ) and participants in the Web-based intervention condition had significantly greater reductions in insomnia and greater increases in minutes per week of vigorous exercise and stretching compared to controls .


There were no significant changes in fruit and vegetable consumption or other outcomes .


The Web-based intervention impacted insomnia and exercise ; however , a majority of the sample met or exceeded national recommendations for health behaviors and were not suffering from depression or fatigue at baseline .


Thus , the survivors were very healthy and well-adjusted upon entry and their ability to make substantial health behavior changes may have been limited .


Future work is discussed , with emphasis placed on ways in which Web-based interventions can be more specifically analyzed for benefit , such as in regard to social networking .


Clinicaltrials.gov NCT00962494 ; http://www.clinicaltrials.gov/ct2/show/NCT00962494 ( Archived by WebCite at http://www.webcitation.org/6NIv8Dc6Q ) .


The GUIDE-IT ( Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure ) study is designed to determine the safety , efficacy , and cost-effectiveness of a strategy of adjusting therapy with the goal of achieving and maintaining a target N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) level of < 1,000 pg/ml compared with usual care in high-risk patients with systolic heart failure ( HF ) .


Elevations in natriuretic peptide ( NP ) levels provide key prognostic information in patients with HF .


Therapies proven to improve outcomes in patients with HF are generally associated with decreasing levels of NPs , and observational data show that decreases in NP levels over time are associated with favorable outcomes .


Results from smaller prospective , randomized studies of this strategy thus far have been mixed , and current guidelines do not recommend serial measurement of NP levels to guide therapy in patients with HF .


GUIDE-IT is a prospective , randomized , controlled , unblinded , multicenter clinical trial designed to randomize approximately 1,100 high-risk subjects with systolic HF ( left ventricular ejection fraction40 % ) to either usual care ( optimized guideline-recommended therapy ) or a strategy of adjusting therapy with the goal of achieving and maintaining a target NT-proBNP level of < 1,000 pg/ml .


Patients in either arm of the study are followed up at regular intervals and after treatment adjustments for a minimum of 12 months .


The primary endpoint of the study is time to cardiovascular death or first hospitalization for HF .


Secondary endpoints include time to cardiovascular death and all-cause mortality , cumulative mortality , health-related quality of life , resource use , cost-effectiveness , and safety .


The GUIDE-IT study is designed to definitively assess the effects of an NP-guided strategy in high-risk patients with systolic HF on clinically relevant endpoints of mortality , hospitalization , quality of life , and medical resourceuse .


( Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [ GUIDE-IT ] ; NCT01685840 ) .


The effects of short-term high-intensity interval training ( HIT ) on cardiac autonomic function are unclear .


The present study assessed cardiac autonomic adaptations to short-term HIT in comparison with aerobic endurance training ( AET ) .


Twenty-six healthy middle-age sedentary men were randomized into HIT ( n = 13 , 4-6 30 s of all-out cycling efforts with 4-min recovery ) and AET ( n = 13 , 40-60 min at 60 % of peak workload ) groups , performing six sessions within 2 wk .


The participants underwent a 24-h ECG recording before and after the intervention and , additionally , recorded R-R interval data in supine position ( 5 min ) at home every morning during the intervention .


Mean HR and low-frequency ( LF ) and high-frequency ( HF ) power of R-R interval oscillation were analyzed from these recordings .


Peak oxygen consumption ( VO2peak ) increased in both groups ( P < 0.001 ) .


Compared with AET ( n = 11 ) , HIT ( n = 13 ) increased 24-h LF power ( P = 0.024 ) , tended to increase 24-h HF power ( P = 0.068 ) , and increased daytime HF power ( P = 0.038 ) .


In home-based measurements , supine HF power decreased on the days after HIT ( P = 0.006 , n = 12 ) but not AET ( P = 0.80 , n = 9 ) session .


The acute response of HF power to HIT session did not change during the intervention .


In conclusion , HIT was more effective short-term strategy to increase R-R interval variability than aerobic training , most probably by inducing larger increases in cardiac vagal activity .


The acute autonomic responses to the single HIT session were not modified by short-term training .


Biomarkers with prognostic and predictive value can help stratify patients with colorectal cancer ( CRC ) into appropriate treatment groups .


We sought to evaluate the clinical utility of P53 protein expression as a biomarker in VICTOR , a large phase III trial of rofecoxib in stage II and III CRC .


Tissue micro arrays were constructed from 884 tumors and the expression of P53 was examined by immunohistochemistry .


Tumors were dichotomised as either P53-positive ( nuclear expression in > 10 % of cells or the ` absent ' pattern , both representing TP53 mutation ) or P53-negative ( nuclear expression in < 10 % of cells ) .


Aberrant P53 expression was found in 65 % ( 482/740 ) of patients .


It was associated with distal location ( p < 0.001 ) and stage III disease ( p < 0.001 ) .


No effect was observed on disease-free or overall survival , and there was no interaction with chemotherapy or radiotherapy .


Analysis of P53 expression in the patients recruited to the VICTOR trial confirmed that P53 expression is associated with site and stage of CRC .


However , independently , this biomarker has neither prognostic nor predictive utility in this cohort of patients .


To assess the efficacy of analgesia provided by continuous ropivacaine wound infiltration after gynecologic laparoscopy .


Sixty patients who underwent gynecologic laparoscopy at Ajou University School of Medicine , Suwon , Republic of Korea , between March and May 2012 were randomized to receive either intravenous fentanyl and ketorolac infusion on demand by patient-controlled analgesia ( IV PCA group , n = 31 ) or continuous wound infiltration of local ropivacaine ( CWI group , n = 29 ) .


Postoperative pain and postoperative nausea and vomiting ( PONV ) were assessed via a visual analog scale .


The number of patients who requested rescue analgesia was recorded .


There was no significant difference in postoperative pain between the 2 groups , but more patients requested rescue analgesia in the CWI group than in the IV PCA group in 24 hours ( 18 versus 9 patients , respectively ; P = 0.010 ) .


The PONV scores at 12 and 24 hours were , respectively , 0.28 and 0.27 in the CWI group , and 0.71 and 0.73 in the IV PCA group ( P = 0.004 ) .


Nine patients requested cessation of IV PCA because of severe nausea or vomiting .


Continuous ropivacaine wound infiltration was found to be as effective as patient-controlled analgesia for postoperative pain relief after gynecologic laparoscopy .


This technique provides good analgesia with less opioid analgesic requirement and few adverse effects .


To assess the reproducibility of an educational intervention EdAl-2 ( Educaci en Alimentaci ) programme in ` Terres de l'Ebre ' ( Spain ) , over 22 months , to improve lifestyles , including diet and physical activity ( PA ) .


Reproduction of a cluster randomised controlled trial .


Two semi-rural town-group primary-school clusters were randomly assigned to the intervention or control group .


Pupils ( n = 690 ) of whom 320 constituted the intervention group ( 1 cluster ) and 370 constituted the control group ( 1 cluster ) .


Ethnicity was 78 % Western European .


The mean age ( SD ) was 8.040.6 years ( 47.7 % females ) at baseline .


Inclusion criteria for clusters were towns from the southern part of Catalonia having a minimum of 500 children aged 7-8 year ; complete data for participants , including name , gender , date and place of birth , and written informed consent from parents or guardians .


The intervention focused on eight lifestyle topics covered in 12 activities ( 1 h/activity/session ) implemented by health promoting agents in the primary school over three academic years .


The primary outcome was obesity ( OB ) prevalence and the secondary outcomes were body mass index ( BMI ) collected every year and dietary habits and lifestyles collected by questionnaires filled in by parents at baseline and end-of-study .


At 22 months , the OB prevalence and BMI values were similar in intervention and control groups .


Relative to children in control schools , the percentage of boys in the intervention group who performed 4 after-school PA h/week was 15 % higher ( p = 0.027 ) , whereas the percentage of girls in both groups remained similar .


Also , 16.6 % more boys in the intervention group watched 2 television ( TV ) h/day ( p = 0.009 ) , compared to controls ; and no changes were observed in girls in both groups .


Our school-based intervention is feasible and reproducible by increasing after-school PA ( to 4 h/week ) in boys .


Despite this improvement , there was no change in BMI and prevalence of OB .


Clinical Trials NCT01362023 .


Many people consume alcoholic beverages following a period of physical activity that results in fluid loss through sweating ( e.g. , after sports , work ) .


Adequate rehydration following physical activity may not occur , consequently resulting in the consumption of alcohol in a dehydrated state .


This may have serious implications for the safety of individuals operating motor vehicles .


Therefore , this study investigated the impact of mild-moderate dehydration in combination with moderate alcohol consumption on simulated driving performance .


Fourteen healthy males participated in a placebo-controlled crossover design study involving 4 experimental trials ( separated by 4 days or more ) .


In each trial , participants were dehydrated by 2 percent body mass through exercise .


After a 30-min recovery , participants completed a 15-min computerized simulated driving task ( drive 1 ) .


In 2 of the trials , participants were provided with water equivalent to either 50 or 150 percent body mass loss and also received salt capsules ( NaCl , 50 mmol/L ) .


A set volume of alcohol or placebo was then consumed in each trial , incorporating the conditions : dehydration-placebo ( DP ) , dehydration-alcohol ( DA ) , partial rehydration-alcohol ( PA ) , and full rehydration-alcohol ( FA ) .


The volume of the alcoholic beverage was individually calculated and intended to raise the blood alcohol content ( BAC ) to 0.05 percent .


The same driving task was then readministered ( drive 2 ) .


Primary outcome measures of driving consisted of standard deviation of lateral position ( SDLP ) , number of side and center line crossings ( LC ) , number of failures to stop at red traffic signals ( FTS ) , number of impacts/collisions with other vehicles or objects ( IMP ) , and time to collision with a specified lead vehicle ( TTC ) .


In addition , reaction time ( RT ) and incorrect inhibition response ( IIR ) behavior to critical events were collected throughout each experimental drive .


Subjective ratings of mood and estimates of alcohol intoxication and driving impairment were also recorded in each trial .


No effects of trial condition were observed on any of the driving performance measures or on subjective ratings of mood , alcohol intoxication , and driving impairment .


SDLP was higher following the consumption of alcohol compared to the placebo trial .


However , no differences in SDLP were recorded between the alcohol trials , indicating that hydration level had no observable interaction with alcohol to influence SDLP performance .


Overall , it appears that dehydration does not exacerbate impairment in driving performance caused by mild-moderate alcohol intoxication .


Further research is required to clarify the effects of alcohol and dehydration at various alcohol doses .


Carboplatin plus paclitaxel administered every 3 weeks is standard first-line chemotherapy for patients with advanced ovarian cancer .


A weekly paclitaxel schedule combined with carboplatin every 3 weeks prolonged progression-free survival and overall survival in a Japanese phase 3 trial .


The aim of our study was to assess whether a weekly schedule of carboplatin plus paclitaxel is more effective than the same drugs given every 3 weeks .


We did a multicentre , randomised , phase 3 study at 67 institutions in Italy and France .


Women with FIGO stage IC-IV ovarian cancer , an ECOG performance status of 2 or lower , and who had never received chemotherapy were randomly allocated in a 1:1 ratio to receive either carboplatin ( AUC 6 mg/mL per min ) plus paclitaxel ( 175 mg/m ( 2 ) ) every 3 weeks for six cycles or carboplatin ( AUC 2 mg/mL per min ) plus paclitaxel ( 60 mg/m ( 2 ) ) every week for 18 weeks .


Randomisation was done by computer-based minimisation , stratified by centre , residual disease after surgery , and ECOG performance status .


The study was not blinded .


Coprimary endpoints were progression-free survival and quality of life ( assessed by the Functional Assessment of Cancer Therapy Ovarian Trial Outcome Index [ FACT-O/TOI ] score ) , and analysis was by modified intention to treat .


This report presents the final analysis .


The study is registered with ClinicalTrials.gov , number NCT00660842 .


822 patients were enrolled into the study between Nov 20 , 2008 , and March 1 , 2012 ; 12 withdrew their consent immediately after randomisation and were excluded , and 810 were eligible for analysis .


404 women were allocated treatment every 3 weeks and 406 were assigned to the weekly schedule .


After median follow-up of 223 months ( IQR 162-309 ) , 449 progression-free survival events were recorded .


Median progression-free survival was 173 months ( 95 % CI 152-202 ) in patients assigned to treatment every 3 weeks , versus 183 months ( 168-209 ) in women allocated to the weekly schedule ( hazard ratio 096 , 95 % CI 080-116 ; p = 066 ) .


FACT-O/TOI scores differed significantly between the two schedules ( treatment-by-time interaction p < 00001 ) ; with treatment every 3 weeks , FACT-O/TOI scores worsened at every cycle ( weeks 1 , 4 , and 7 ) , whereas for the weekly schedule , after transient worsening at week 1 , FACT-O/TOI scores remained stable .


Fewer patients assigned to the weekly group than those allocated treatment every 3 weeks had grade 3-4 neutropenia ( 167 [ 42 % ] of 399 patients vs 200 [ 50 % ] of 400 patients ) , febrile neutropenia ( two [ 05 % ] vs 11 [ 3 % ] ) , grade 3-4 thrombocytopenia ( four [ 1 % ] vs 27 [ 7 % ] ) , and grade 2 or worse neuropathy ( 24 [ 6 % ] vs 68 [ 17 % ] ) .


Three deaths during the study were attributed to chemotherapy ; two women died who were allocated treatment every 3 weeks and one death was recorded in the group assigned the weekly regimen .


A weekly regimen of carboplatin and paclitaxel might be a reasonable option for first-line treatment of women with advanced ovarian cancer .


None .


Cognitive impairments contribute significantly to inadequate functional recovery following illness episodes in bipolar disorder , yet data on treatment interventions are sparse .


We assessed the cognitive effects of a standardized extract of the medicinal herb Withania somnifera ( WSE ) in bipolar disorder .


Sixty euthymic subjects with DSM-IV bipolar disorder were enrolled in an 8-week , double-blind , placebo-controlled , randomized study of WSE ( 500 mg/d ) as a procognitive agent added adjunctively to the medications being used as maintenance treatment for bipolar disorder .


Study enrollment and data analyses were completed between December 2008 and September 2012 .


Cognitive testing at baseline and 8 weeks assessed primary efficacy outcomes .


Psychopathology and adverse events were monitored at scheduled visits .


Fifty-three patients completed the study ( WSE , n = 24 ; placebo , n = 29 ) , and the 2 groups were matched in terms of demographic , illness , and treatment characteristics .


Compared to placebo , WSE provided significant benefits for 3 cognitive tasks : digit span backward ( P = .035 ) , Flanker neutral response time ( P = .033 ) , and the social cognition response rating of the Penn Emotional Acuity Test ( P = .045 ) .


The size of the WSE treatment effect for digit span backward was in the medium range ( Cohen d = 0.51 ; 95 % CI , 0.25-0 .77 ) .


None of the other cognitive tasks showed significant between-group differences .


Mood and anxiety scale scores remained stable , and adverse events were minor .


Although results are preliminary , WSE appears to improve auditory-verbal working memory ( digit span backward ) , a measure of reaction time , and a measure of social cognition in bipolar disorder .


Given the paucity of data for improving cognitive capacity in bipolar disorder , WSE offers promise , appears to have a benign side-effects profile , and merits further study .


ClinicalTrials.gov identifier : NCT00761761 .


Rapid diagnosis and accurate detection of etiological agents in pyogenic spinal infection ( PSI ) patients are important .


The purpose of this study was to evaluate the clinical usefulness of methicillin-resistant Staphylococcus-specific polymerase chain reaction ( MRS-PCR ) and broad-range universal PCR ( U-PCR ) for diagnosing PSI .


A prospective diagnostic study .


Thirty-two clinically suspect PSI patients and six control patients who underwent computerized tomography-guided biopsy and/or surgical treatment were enrolled .


Tissue samples were examined by microbiological culture , histopathology , and real-time PCR ( MRS-PCR and U-PCR ) .


The diagnostic accuracy of real-time PCR was analyzed based on the definitive diagnosis of infection , defined as a positive result from microbiological culture or histopathology .


All six control subjects were negative for PSI for all analyses .


Twelve clinically suspect PSI subjects received definitive diagnoses ( PSI group ) .


The non-PSI group consisted of six control subjects plus the remaining 20 patients from the PSI clinically suspect group .


MRS-PCR results were positive for all MRS-cultured PSI subjects .


U-PCR was positive for all subjects in the PSI group with one discrepancy between real-time PCR and microbiological culture results in differentiation between gram-positive and gram-negative bacteria .


In the non-PSI group , MRS-PCR and U-PCR were positive in three and seven cases , respectively .


The sensitivity , specificity , positive predictive value , and negative predictive value of MRS-PCR for diagnosing MRS infection were 1.00 , 0.91 , 0.57 , and 1.00 , respectively ; those for the diagnosis of bacterial infection with U-PCR were 1.00 , 0.73 , 0.63 , and 1.00 , respectively .


Identification of MRS infection and ability to differentiate between gram-positive and gram-negative bacteria is rapidly achieved using MRS-PCR and U-PCR .


Real-time PCR provides a sensitive molecular diagnosis of PSI and may contribute to antibiotic selection .


To evaluate radiation dose , image quality , and optimal level of sinogram-affirmed iterative reconstruction ( SAFIRE ) of cerebral CT angiography ( CTA ) at 70 kVp .


One hundred patients were prospectively classified into two groups : Group A ( n = 50 ) , 70 kVp cerebral CTA with 5 levels of SAFIRE reconstruction ( S1-S5 ) ; and Group B ( n = 50 ) , 120 kVp with filtered back projection ( FBP ) reconstruction .


CT attenuation values , noise , signal-to-noise ratio ( SNR ) and contrast-to-noise ratio ( CNR ) of the internal carotid artery ( ICA ) and middle cerebral artery ( MCA ) were measured .


Subjective image quality was evaluated .


Effective dose ( ED ) was estimated .


CT attenuation and noise of the ICA and MCA in Group A were higher than those of Group B ( all P < 0.001 ) while the SNRICA , SNRMCA , CNRICA , and CNRMCA of Group A at S4-5 were comparable to ( P > 0.05 ) or higher than in Group B ( P < 0.05 ) .


There was no difference in overall image quality between Group A S3-5 and Group B ( P > 0.05 ) .


ED was 0.20.0 mSv for Group A with 85 % ED reduction in comparison to Group B ( 1.30.2 mSv ) .


Cerebral CTA at 70 kVp is feasible , allowing for substantial radiation dose reduction .


SAFIRE S4 level is recommended for obtaining optimal image quality .


70 kVp cerebral CTA is feasible and provides diagnostic image quality .


70 kVp cerebral CTA resulted in 85 % effective dose reduction .


S4 level of SAFIRE is recommended for 70 kVp cerebral CTA .


Relapse after cessation of desmopressin is an important problem in treating patients with enuresis .


Structured withdrawal of desmopressin tablets has been shown to decrease relapse rates .


However , scientific data are lacking onthe structured withdrawal of the fast melting oral formulation of desmopressin .


We compared relapse rates of structured withdrawal using placebo and direct cessation in a population of patients with enuresis who were desmopressin responders .


Patients diagnosed with enuresis and responding todesmopressin from 13 different centers were involved in the study .


Patients wererandomized into 4 groups .


Two different structured withdrawal strategies were compared to placebo and direct withdrawal .


Sample size was estimated as240 ( 60 patients in each group ) , with a power of 0.80 and an effect size of30 % .


Randomization was performed using NCSS statistical software ( NCSS , Kaysville , Utah ) from a single center .


The relapse rates of the groups were compared using chi-square testing .


Logistic regression analysis was performed todefine the independent factors having an effect onrelapse rates .


Desmopressin treatment was initiated in 421 patients , and 259 patients were eligible for randomization .


Relapse rates were 39 ( 1 % ) and 42 ( 4 % ) for the structured withdrawal groups , which were significantly less than for direct withdrawal ( 55 , 3 % ) and placebo ( 53 , 1 % ) .


Logistic regression analysis revealed that initial effective dose of 240 cg , greater number of wet nights before treatment and nonstructured withdrawal were associated with higher relapse rates .


We found that structured withdrawal with the fast melting oralformulation of desmopressin results in decreased relapse rates .


Application of astructured withdrawal program was also an independent factor associated withreduced relapse rates , together with lower initial effective dose and number of wet nights per week .


Relapse after cessation of desmopressin is an important problem , and in this study structured withdrawal was observed to be associated with decreased relapse rates compared to placebo and direct withdrawal .


The Cardiothoracic Surgical Trials Network recently reported no difference in the primary end point of left ventricular end-systolic volume index at 1 year postsurgery in patients randomized to repair ( n = 126 ) or replacement ( n = 125 ) for severe ischemic mitral regurgitation .


However , patients undergoing repair experienced significantly more recurrent mitral regurgitation than patients undergoing replacement ( 32.6 % vs 2.3 % ) .


We examined whether baseline echocardiographic and clinical characteristics could identify those who will develop moderate/severe recurrent mitral regurgitation or die .


Our analysis includes 116 patients who were randomized to and received mitral valve repair .


Logistic regression was used to estimate a model-based probability of recurrence or death from baseline factors .


Receiver operating characteristic curves were constructed from these estimated probabilities to determine classification cut-points maximizing accuracy of prediction based on sensitivity and specificity .


Of the 116 patients , 6 received a replacement before leaving the operating room ; all other patients had mild or less mitral regurgitation on intraoperative echocardiogram after repair .


During the 2-year follow-up period , 76 patients developed moderate/severe mitral regurgitation or died ( 53 mitral regurgitation recurrences , 13 mitral regurgitation recurrences and death , and 10 deaths ) .


The mechanism for recurrent mitral regurgitation was largely mitral valve leaflet tethering .


Our model ( including age , body mass index , sex , race , effective regurgitant orifice area , basal aneurysm/dyskinesis , New York Heart Association class , history of coronary artery bypass grafting , percutaneous coronary intervention , or ventricular arrhythmias ) yielded an area under the receiver operating characteristic curve of 0.82 .


The model demonstrated good discrimination in identifying patients who will survive 2 years without recurrent mitral regurgitation after mitral valve repair .


Although our results require validation , they offer a clinically relevant risk score for selection of surgical candidates for this procedure .


To examine the associations between post-traumatic stress disorder ( PTSD ) symptoms , stimulant use , and treatment outcomes among dually diagnosed women .


Participants were 141 women who participated in a multisite clinical trial of group treatments for PTSD and addictions .


Generalized linear models indicated Seeking Safety ( SS ; a cognitive-behavioral intervention ) was significantly more effective than Women 's Health Education ( WHE ; a control group intervention ) in reducing stimulant use at follow-up among women who were heavy stimulant users at pre-treatment and who showed improvements in PTSD symptoms .


There were no significant differences between the interventions among women who were light stimulant users at treatment entry .


These findings suggest that integrated treatment of co-occurring PTSD and addictions may be more effective than general health education approaches for heavy stimulant users .


Assessment of frequency of stimulant use among individuals with PTSD symptoms may inform treatment selection for this population .


The prevention of central venous catheter ( CVC ) associated bloodstream infections ( CABSIs ) in paediatric oncology patients is essential .


Ethanol locks can eliminate pathogens colonising CVCs and microbial resistance is rare .


Aim of this study was to determine whether two hour 70 % ethanol locks can reduce CABSI in paediatric oncology patients .


We conducted a randomised , double blind , multi-centre trial in paediatric oncology patients ( 1-18 years ) with newly inserted CVCs .


Patients were randomly assigned to receive two hour ethanol locks ( 1.5 or 3 ml 70 % ) or heparin locks ( 1.5 or 3 ml 100 IU/ml ) , whenever it was needed to use the CVC , maximum frequency once weekly .


Primary outcomes were time to CABSI or death due to CABSI .


We recruited 307 patients ( ethanol , n = 153 ; heparin , n = 154 ) .


In the ethanol group , 16/153 ( 10 % ) patients developed a CABSI versus 29/154 ( 19 % ) in the heparin group .


The incidence of CABSI was 0.77 / 1000 and 1.46 / 1000 catheter days respectively ( p = 0.039 ) .


The number-needed-to-treat was 13 .


No patients died of CABSI .


In particular , Gram-positive CABSIs were reduced ( ethanol , n = 8 ; heparin , n = 21 ; p = 0.012 ) .


Fewer CVCs were removed because of CABSI in the ethanol group ( p = 0.077 ) .


The ethanol lock patients experienced significantly more transient symptoms compared to the heparin lock patients ( maximum grade 2 ) ( nausea , p = 0.030 ; taste alteration , p < 0.001 ; dizziness , p = 0.001 ; blushing , p < 0.001 ) , no suspected unexpected serious adverse reactions ( SUSAR ) occurred .


This is the first randomised controlled trial to show that ethanol locks can prevent CABSI in paediatric oncology patients , in particular CABSI caused by Gram-positive bacteria .


Implementation of ethanol locks in clinical practice should be considered .


Diabetes may confer an increased risk for the cardiovascular health effects of particulate air pollution , but few human clinical studies of air pollution have included people with diabetes .


Ultrafine particles ( UFP , 100 nm in diameter ) have been hypothesized to be an important component of particulate air pollution with regard to cardiovascular health effects .


17 never-smoker subjects 30-60 years of age , with stable type 2 diabetes but otherwise healthy , inhaled either filtered air ( 0-10 particles/cm3 ) or elemental carbon UFP ( ~ 107 particles/cm3 , ~ 50 ug/m3 , count median diameter 32 nm ) by mouthpiece , for 2 hours at rest , in a double-blind , randomized , crossover study design .


A digital 12-lead electrocardiogram ( ECG ) was recorded continuously for 48 hours , beginning 1 hour prior to exposure .


Analysis of 5-minute segments of the ECG during quiet rest showed reduced high-frequency heart rate variability with UFP relative to air exposure ( p = 0.014 ) , paralleled by non-significant reductions in time-domain heart rate variability parameters .


In the analysis of longer durations of the ECG , we found that UFP exposure increased the heart rate relative to air exposure .


During the 21 - to 45-hour interval after exposure , the average heart rate increased approximately 8 beats per minute with UFP , compared to 5 beats per minute with air ( p = 0.045 ) .


There were no UFP effects on cardiac rhythm or repolarization .


Inhalation of elemental carbon ultrafine particles alters heart rate and heart rate variability in people with type 2 diabetes .


Our findings suggest that effects may occur and persist hours after a single 2-hour exposure .


The most common side-effect of ablative fractional skin resurfacing in Asians is post inflammatory hyperpigmentation ( PIH ) .


Various attempts have been made to reduce the occurrence of PIH after laser treatment including sun avoidance , the use of preoperative and postoperative treatment regimens , and treatment using conservative energy settings and epidermal protection .


To determine whether the use of broad-spectrum sunscreen with anti-inflammatory agents starting on the first day after fractional CO2 laser skin resurfacing reduces the incidence of post laser PIH .


Thirty patients were treated with ablative fractional CO2 resurfacing on both sides of their faces at 10mJ and 10 % density .


Each subject was randomly treated on one side of the face with petrolatum ointment four times a day for the first week after laser treatment and on the other side of the face with petrolatum ointment four times a day plus broad-spectrum sunscreen with anti-inflammatory agents in the morning starting on the first day after laser treatment .


Transepidermal water loss was recorded at baseline and every day for 1week .


Melanin and erythema indexes were measured at baseline , 1 - , 2-week , 1 - , 2 - and at 3-month post treatment .


Of the 30 patients involved in the study , 26 received the treatment and attended 1 - , 2-week , 1 - , 2 - and 3-month post-treatment visits .


Four patients were withdrawn from the study because they could not attend every follow-up visit .


There was no statistically significant difference in transepidermal water loss at baseline , immediately after laser treatment , or at the D1 to D7 follow-up visits .


Erythema index had no significantly statistical difference at baseline , 1 - , 2 - and at 3-month after laser treatment .


Furthermore , there was a statistically significant difference in melanin index at 1-week post laser treatment between both sides ( P = 0.001 ) .


Melanin index at the 1-week follow-up visit on the side treated with broad-spectrum sunscreen with anti-inflammatory agents starting on the first day after laser treatment was significantly less than the control side .


The use of broad-spectrum sunscreen with anti-inflammatory agents starting on the first day after ablative fractional skin resurfacing can decrease the incidence of PIH after laser treatment at 1-week postoperatively .


To prospectively evaluate image quality and radiation dose using a low-dose computed tomography angiography protocol and iterative image reconstruction for high-pitch dual-source CT-angiography ( DSCTA ) of the supraaortic arteries .


DSCTA was performed in 42 patients , using either 120 kVp tube voltage , 120 mAS tube current , 2.4 pitch and filtered back projection , or 100 kVp tube voltage , 100 mAs tube current , 3.2 pitch , and sinogram affirmed iterative reconstruction .


Measurements of vessel attenuation , of the contrast-to-noise ratio ( CNR ) and the signal-to-noise ratio ( SNR ) were performed to objectively evaluate image quality .


Two readers evaluated subjective image quality and image noise , using a four-point scale .


Effective dose was used to compare the differences in radiation dose .


Low-dose protocol application showed significantly higher vessel opacification ( p = 0.013 ) , and non-significantly higher CNR and SNR values .


There was no difference in the subjective image quality and image noise reading between the protocols .


Effective dose was significantly lower using the low-dose protocol ( 1.29 0.21 mSv vs. 2.92 0.72 mSv ; p < 0.001 ) .


The combined use of reduced tube voltage , reduced tube current , and iterative reconstruction reduces radiation dose by 55.4 % in high-pitch DSCTA of the supraaortic arteries without impairment of image quality .


To investigate the efficacy of premedication with pronase , a proteolytic enzyme , in improving image quality during magnifying endoscopy .


The study was of a blinded , randomized , prospective design .


Patients were assigned to groups administered oral premedication of either pronase and simethicone ( Group A ) or simethicone alone ( Group B ) .


First , the gastric mucosal visibility grade ( 1-4 ) was determined during conventional endoscopy , and then a magnifying endoscopic examination was conducted .


The quality of images obtained by magnifying endoscopy at the stomach and the esophagus was scored from 1 to 3 , with a lower score indicating better visibility .


The endoscopist used water flushes as needed to obtain satisfactory magnifying endoscopic views .


The main study outcomes were the visibility scores during magnifying endoscopy and the number of water flushes .


A total of 144 patients were enrolled , and data from 143 patients ( M : F = 90:53 , mean age 57.5 years ) were analyzed .


The visibility score was significantly higher in the stomach following premedication with pronase ( 73 % with a score of 1 in Group A vs 49 % in Group B , P < 0.05 ) , but there was no difference in the esophagus visibility scores ( 67 % with a score of 1 in Group A vs 58 % in Group B ) .