The experimental arms received an asynchronous e-learning curriculum consisting of nine Web-based , interactive , peer-reviewed Flash/HTML5 modules .


Postrotation testing and in-training examination ( ITE ) scores quantified improvements in knowledge .


A 2 2 analysis of covariance ( ANCOVA ) tested interaction and main effects , and Pearson 's correlation tested associations between module usage , scores , and ITE scores .


A total of 256 of 458 participants completed all study elements ; 104 had access to asynchronous e-learning modules , and 152 were controls who used the current education standards .


No pretest sensitization was found ( p = 0.75 ) .


Use of asynchronous e-learning modules was associated with an improvement in posttest scores ( p < 0.001 ) , from a mean score of 18.45 ( 95 % confidence interval [ CI ] = 17.92 to 18.98 ) to 21.30 ( 95 % CI = 20.69 to 21.91 ) , a large effect ( partial ( 2 ) = 0.19 ) .


Posttest scores correlated with ITE scores ( r ( 2 ) = 0.14 , p < 0.001 ) among pediatric residents .


Asynchronous e-learning is an effective educational tool to improve knowledge in a clinical rotation .


Web-based asynchronous e-learning is a promising modality to standardize education among multiple institutions with common curricula , particularly in clinical rotations where scheduling difficulties , seasonality , and variable experiences limit in-hospital learning .


Apnoea , desaturations and bradycardias are common problems in preterm infants which can be treated with nasal continuous positive airway pressure ( NCPAP ) and nasal intermittent positive pressure ventilation ( NIPPV ) .


It is unclear whether synchronised NIPPV ( SNIPPV ) would be even more effective .


To assess the effects of flow-SNIPPV , NIPPV and NCPAP on the rate of desaturations and bradycardias in preterm infants and , secondarily , to evaluate their influence on pattern of breathing and gas exchange .


Nineteen infants ( mean gestational age at study 30weeks , 9 boys ) with apnoeic spells were enrolled in a randomised controlled trial with a cross-over design .


They received flow-SNIPPV , NIPPV and NCPAP for 4h each .


All modes were provided by a nasal conventional ventilator able to provide synchronisation by a pneumotachograph .


The primary outcome was the event rate of desaturations ( 80 % arterial oxygen saturation ) and bradycardias ( 80bpm ) per hour , obtained from cardiorespiratory recordings .


The incidence of central apnoeas ( 10s ) as well as baseline heart rate , FiO2 , SpO2 , transcutaneous blood gases and respiratory rate were also evaluated .


The median event rate per hour during flow-SNIPPV , NIPPV and NCPAP was 2.9 , 6.1 and 5.9 , respectively ( p < 0.001 and 0.009 , compared with flow-SNIPPV ) .


Central apnoeas per hour were 2.4 , 6.3 and 5.4 , respectively ( p = 0.001 , for both compared with flow-SNIPPV ) , while no differences in any other parameter studied were recorded .


Flow-SNIPPV seems more effective than NIPPV and NCPAP in reducing the incidence of desaturations , bradycardias and central apnoea episodes in preterm infants .


The aim of this study was to investigate the effect of different types of anesthesia on stress hormones .


The study was included 60 ASAI-II cases scheduled for major lower extremity surgery .


The cases were randomized into 2 groups : The EA group was administered epidural anesthesia and the GA group was administered standard general anesthesia .


In order to evaluate the surgical trauma - related stress response , CRP , TSH , cortisol , and fasting blood sugar ( FBS ) levels were measured preoperatively , 30 min after surgical incision , and 24 h post surgery .


Between-group comparisons ; Preoperative values were not significantly different between the groups .


( P > 0,05 ) Pulse rate and cortisol values significantly higher in general group at 30 min .


( P < 0,05 ) , and the FBS values were significantly higher in the epidural group at 24 h. ( P < 0,05 ) There were not found differences for other parameters at evaluation times .


No differences were observed between the two anesthesia methods , in terms of minimizing the stress response due to surgical trauma during major low extremity surgery .


Inactivated polio vaccine ( IPV ) is necessary for global polio eradication because oral polio vaccine can rarely cause poliomyelitis as it mutates and may fail to provide adequate immunity in immunocompromised populations .


However , IPV is unaffordable for many developing countries .


Intradermal IPV shows promise as a means to decrease the effective dose and cost of IPV , but prior studies , all using 20 % of the standard dose used in intramuscular IPV , resulted in inferior antibody titers .


We randomly assigned 231 adults with well-controlled human immunodeficiency virus infection at a ratio of 2:2:2:1 to receive 40 % of the standard dose of IPV intradermally , 20 % of the standard dose intradermally , the full standard dose intramuscularly , or 40 % of the standard dose intramuscularly .


Intradermal vaccination was done using the NanoPass MicronJet600 microneedle device .


Baseline immunity was 87 % , 90 % , and 66 % against poliovirus serotypes 1 , 2 , and 3 , respectively .


After vaccination , antibody titers increased a median of 64-fold .


Vaccine response to 40 % of the standard dose administered intradermally was comparable to that of the standard dose of IPV administered intramuscularly and resulted in higher ( although not significantly ) antibody titers .


Intradermal administration had higher a incidence of local side effects ( redness and itching ) but a similar incidence of systemic side effects and was preferred by study participants over intramuscular administration .


A 60 % reduction in the standard IPV dose without reduction in antibody titers is possible through intradermal administration .


A current recommendation for locoregionally advanced nasopharyngeal carcinoma ( NPC ) is conventional fractionated radiotherapy with concurrent cisplatin plus adjuvant cisplatin and fluorouracil ( PF ) .


In this randomized trial , the authors evaluated the potential therapeutic benefit from changing to an induction-concurrent chemotherapy sequence , replacing fluorouracil with oral capecitabine , and/or using accelerated rather than conventional radiotherapy fractionation .


Patients with stage III through IVB , nonkeratinizing NPC were randomly allocated to 1 of 6 treatment arms .


The protocol was amended in 2009 to permit confining randomization to the conventional fractionation arms .


The primary endpoint was progression-free survival .


Secondary endpoints included overall survival and safety .


In total , 803 patients were accrued , and 706 patients were randomly allocated to all 6 treatment arms .


Comparisons of induction PF versus adjuvant PF did not indicate a significant improvement .


Unadjusted comparisons of induction cisplatin and capecitabine ( PX ) versus adjuvant PF indicated a favorable trend in progression-free survival for the conventional fractionation arm ( P = .045 ) ; analyses that were adjusted for other significant factors and fractionation reflected a significant reduction in the hazards of disease progression ( hazard ratio [ HR ] , 0.54 ; 95 % confidence interval [ CI ] , 0.36-0 .80 ) and death ( HR , 0.42 ; 95 % CI , 0.25-0 .70 ) .


Unadjusted comparisons of induction sequences versus adjuvant sequences did not reach statistical significance , but adjusted comparisons indicated favorable improvements by induction sequence .


Comparisons of induction PX versus induction PF revealed fewer toxicities ( neutropenia and electrolyte disturbance ) , unadjusted comparisons of efficacy were statistically insignificant , but adjusted analyses indicated that induction PX had a lower hazard of death ( HR , 0.57 ; 95 % CI , 0.34-0 .97 ) .


Changing the fractionation from conventional to accelerated did not achieve any benefit but incurred higher toxicities ( acute mucositis and dehydration ) .


Preliminary results indicate that the benefit of changing to an induction-concurrent sequence remains uncertain ; replacing fluorouracil with oral capecitabine warrants further validation in view of its convenience , favorable toxicity profile , and favorable trends in efficacy ; and accelerated fractionation is not recommended for patients with locoregionally advanced NPC who receive chemoradiotherapy .


Cannabis is the most frequently used illegal substance in the United States and Europe .


There is a dramatic increase in the demand for treatment for cannabis dependence .


Cannabis users frequently have co-morbid mood symptoms , especially depression and anxiety , and regular cannabis users may self-medicate for such symptoms .


We report a double-blind , placebo-controlled treatment study , for the prevention of cannabis use in cannabis-dependent individuals .


Regular cannabis-dependent users ( n = 52 ) were treated for 9 weeks with weekly cognitive-behavior and motivation-enhancement therapy sessions together with escitalopram 10mg/day .


Urine samples were collected to monitor delta-9 tetrahydrocannabinol ( THC ) during treatment and questionnaires were administered to assess anxiety and depression .


We observed a high rate of dropout ( 50 % ) during the 9-week treatment program .


Fifty-two patients were included in the intention-to-treat analysis .


Of these , ten ( 19 % ) remained abstinent after 9 weeks of treatment as indicated by negative urine samples for THC .


Escitalopram provided no advantage over placebo in either abstinence rates from cannabis or anxiety and depression scores during the withdrawal and abstinent periods .


Escitalopram treatment does not provide an additional benefit either for achieving abstinence , or for the treatment of the cannabis withdrawal syndrome .


Due to limitations of our study , namely , a high dropout rate and effects of low abstinence rates on measures of anxiety , depression and withdrawal , it is premature to conclude that selective serotonin reuptake inhibitors are not effective for treatment of the cannabis withdrawal syndrome .


Contrast medium-induced acute kidney injury ( CI-AKI ) is a cardiovascular complication after myocardial infarction treated with emergency percutaneous coronary intervention .


The aim of this randomized , sham-controlled trial was to evaluate the impact of remote ischemic preconditioning ( RIPC ) on CI-AKI in patients with ST-elevation myocardial infarction who received emergency primary percutaneous coronary intervention .


Patients with a suspected ST-elevation myocardial infarction were randomly assigned at a 1:1 ratio to receive percutaneous coronary intervention either with ( n = 63 ) or without ( n = 62 ) RIPC ( intermittent arm ischemia through three cycles of 5min of inflation and 5min of deflation of a blood pressure cuff ) .


A total of 47 RIPC patients and 47 control patients met all study criteria .


The primary endpoint was the incidence of CI-AKI , which was defined as an increase in serum creatinine > 0.5 mg/dL or > 25 % over the baseline value 48-72h after administration of contrast medium .


The incidence of CI-AKI was 10 % ( n = 5 ) in the RIPC group and 36 % ( n = 17 ) in the control group ( p = 0.003 ) .


The odds ratio of CI-AKI in patients who received RIPC was 0.18 ( 95 % confidence interval : 0.05-0 .64 ; p = 0.008 ) .


In patients with ST-elevation myocardial infarction , RIPC before percutaneous coronary intervention reduced the incidence of CI-AKI .


We studied adjuvant daily sildenafil citrate during and after radiotherapy for prostate cancer for erectile function preservation .


We performed a randomized , prospective trial of 279patients with localized prostate cancer treated with radiotherapy who received sildenafil citrate ( 50 mg daily ) or placebo ( 2:1 randomization ) .


Medication/placebo was initiated 3 days before treatment and continued daily for 6months .


Before therapy and 3 , 6 , 9 , 12 , 18 and 24 months after radiotherapy patients completed the IIEF questionnaire , including the erectile function domain , the I-PSS questionnaire and the RAND SF-36 .


All IIEF domains werescored .


At 12 months erectile function scores were better for sildenafil citrate than placebo ( p = 0.018 ) , 73 % of patients on sildenafil citrate vs 50 % on placebo had mild/no erectile dysfunction ( p = 0.024 ) and the sildenafil citrate arm had superior overall satisfaction ( p = 0.027 ) and IIEF total scores ( p = 0.043 ) .


At 24months erectile function and IIEF scores were no longer significantly better for sildenafil citrate ( p = 0.172 and 0.09 , respectively ) and yet overall satisfaction scores were higher ( p = 0.033 ) .


Sexual desire scores in patients who received sildenafil citrate were higher at 24 months although they had completed drug therapy 18 months previously ( p = 0.049 ) .


At 24 months 81.6 % of patients on sildenafil citrate and 56.0 % of those on placebo achieved functional erection with or without erectile dysfunction medication ( p = 0.045 ) .


Daily sildenafil citrate during and after radiotherapy for prostate cancer was associated with improved overall sexual function compared with placebo for various sexual function domains .


To our knowledge this is the largestrandomized , prospective , controlled trial to show the usefulness of a phosphodiesterase-5 inhibitor as a rehabilitation strategy in patients with prostate cancer who received radiation therapy .


EPHESUS was a multicentre , double-blind clinical trial in which 6632 patients with acute myocardial infarction ( AMI ) complicated by LV systolic dysfunction ( LVSD ) were randomized to receive eplerenone ( n = 3319 ) or placebo ( n = 3313 ) .


A total of 1580 EPHESUS patients were treated with PCI , which is now the standard treatment for AMI .


This EPHESUS substudy examined the effects of eplerenone upon cardiovascular outcomes in PCI-treated patients .


EPHESUS patients were divided into PCI-treated and non-PCI-treated cohorts , and the effect of eplerenone upon mortality and other major adverse cardiovascular outcomes was assessed in each cohort .


The PCI-treated patients ( n = 1580 ) were younger , and had better renal function and fewer co-morbidities than non-PCI-treated patients ( n = 5052 ) .


Cardiovascular mortality was significantly lower in PCI-treated patients as compared with non-PCI-treated patients ( 7 % vs. 16 % , P < 0.0001 ) .


However , the incidence of non-fatal events was similar in PCI-treated and non-PCI-treated cohorts .


There was no statistical difference between the PCI-treated and non-PCI-treated cohorts in the primary or secondary outcomes of the trial .


Eplerenone administration , compared with placebo , in the PCI-treated cohort did not affect PCI-related clinical outcomes , including recurrence of angina , the occurrence of acute coronary syndromes , or the need for further revascularization .


The beneficial effects of eplerenone in the EPHESUS trial exist for both PCI - and non-PCI-treated AMI patients with LVSD .


Eplerenone has minimal , if any , effect upon reducing PCI-related adverse events in the PCI-treated cohort .


To test whether elevated umbilical cord serum inflammatory cytokine levels predicted subsequent cerebral palsy ( CP ) or neurodevelopmental delay ( NDD ) .


Nested case-control analysis within a clinical trial of antenatal magnesium sulfate ( MgSO4 ) before anticipated preterm birth ( PTB ) for prevention of CP , with evaluation of surviving children at the age of 2 .


NDD was defined as a Bayley psychomotor developmental index ( PDI ) and/or mental developmental index ( MDI ) < 70 .


Controls , defined as surviving children without CP and with Bayley PDI and MDI85 , were matched by race and gestational age .


Cord serum was analyzed for interleukin-8 ( IL-8 ) interleukin-1 beta ( IL-1 ) , and tumor necrosis factor - ( TNF - ) levels .


Elevated cytokine levels were defined as75th percentile in placebo-exposed controls .


Analyses compared case/control cytokine levels , adjusting for MgSO4 exposure , gestational age , race/ethnicity , and sociodemographic differences .


Logistic regression analysis with 339 cases and 276 controls showed that elevated IL-8 and IL-1 were more common in cord blood serum from infants with subsequent low MDI as compared with controls .


After adjusting for additional confounders , the significant differences were no longer evident .


Cytokine levels ( IL-8 , IL-1 , and TNF - ) were not elevated with CP or low PDI .


Cord serum IL-8 , IL-1 , and TNF - levels in preterm infants are not associated with subsequent CP or NDD .


Multiple tasking is an integral part of daily mobility .


Patients with Parkinson 's disease have dual tasking difficulties due to their combined motor and cognitive deficits .


Two contrasting physiotherapy interventions have been proposed to alleviate dual tasking difficulties : either to discourage simultaneous execution of dual tasks ( consecutive training ) ; or to practice their concurrent use ( integrated training ) .


It is currently unclear which of these training methods should be adopted to achieve safe and consolidated dual task performance in daily life .


Therefore , the proposed randomized controlled trial will compare the effects of integrated versus consecutive training of dual tasking ( tested by combining walking with cognitive exercises ) .


Hundred and twenty patients with Parkinson 's disease will be recruited to participate in this multi-centered , single blind , randomized controlled trial .


Patients in Hoehn & Yahr stage II-III , with or without freezing of gait , and who report dual task difficulties will be included .


All patients will undergo a six-week control period without intervention after which they will be randomized to integrated or consecutive task practice .


Training will consist of standardized walking and cognitive exercises delivered at home four times a week during six weeks .


Treatment is guided by a physiotherapist twice a week and consists of two sessions of self-practice using an MP3 player .


Blinded testers will assess patients before and after the control period , after the intervention period and after a 12-week follow-up period .


The primary outcome measure is dual task gait velocity , i.e. walking combined with a novel untrained cognitive task to evaluate the consolidation of learning .


Secondary outcomes include several single and dual task gait and cognitive measures , functional outcomes and a quality of life scale .


Falling will be recorded as a possible adverse event using a weekly phone call for the entire study period .


This randomized study will evaluate the effectiveness and safety of integrated versus consecutive task training in patients with Parkinson 's disease .


The study will also highlight whether dual task gait training leads to robust motor learning effects , and whether these can be retained and carried-over to untrained dual tasks and functional mobility .


Clinicaltrials.gov NCT01375413 .


To evaluate the efficacy of a novel , angular , continuous passive motion device for self-treatment at home in patients with mild-to-moderate , non-specific , chronic low back pain ( LBP ) .


Prospective , randomised , waiting-list-controlled ( WLC ) trial .


Recruitment and assessment were conducted at the Koren Centre for Physical Therapy .


Self-treatment was performed at home .


Thirty-six patients with a score 6 on the numeric rating scale ( NRS ) for pain were enrolled .


Twenty-eight patients completed treatment .


Participants were randomised to receive the Kyrobak ( Radiancy , Hod-hasharon , Israel ) at enrolment [ immediate treatment ( IT ) group ] or 3 weeks later ( WLC group ) .


Self-treatment was prescribed for 10minutes , one to three times per day , for 3 weeks .


The treatment period was followed by a 3-week follow-up period .


Primary outcome was self-reported pain level ( NRS ) .


Three weeks of self-treatment with the Kyrobak reduced pain levels significantly in the IT group compared with the WLC group { mean [ standard deviation ( SD ) ] NRS score from baseline to post-treatment : IT group , 1.4 ( 1.5 ) , 95 % confidence interval ( CI ) 0.5 to 2.3 ; WLC group , -0.1 ( 2.2 ) , 95 % CI -1.1 to 1.2 ; effect mean difference 1.5 } .


This benefit was maintained over the follow-up period [ from baseline to end of follow-up , mean ( SD ) NRS score 1.1 ( 1.8 ) , 95 % CI 0.4 to 1.8 ] .


Multi-linear regression analysis found that higher baseline pain resulted in greater pain reduction ( P = 0.003 ) .


Eighty-three percent of participants with a baseline NRS score > 4.35 ( threshold determined by logistic regression , P = 0.01 ) achieved the minimal important change criterion of NRS score 2 .


Daily NRS score reduced gradually over the treatment period [ regression slope -0.052 ( 0.01 ) , 95 % CI -0.07 to -0.03 ] .


Preliminary evidence suggests that the Kyrobak may be beneficial for short-term relief of non-specific , chronic LBP , particularly in participants with a moderate level of pain .


A longer treatment period may lead to a further reduction in pain .


Our objective was to assess the safety , feasibility , and effects of the standardized 8-week mindfulness-based stress reduction ( MBSR ) course in adults with migraines .


Stress is a well-known trigger for headaches .


Research supports the general benefits of mind/body interventions for migraines , but there are few rigorous studies supporting the use of specific standardized interventions .


MBSR is a standardized 8-week mind/body intervention that teaches mindfulness meditation/yoga .


Preliminary research has shown MBSR to be effective for chronic pain syndromes , but it has not been evaluated for migraines .


We conducted a randomized controlled trial with 19 episodic migraineurs randomized to either MBSR ( n = 10 ) or usual care ( n = 9 ) .


Our primary outcome was change in migraine frequency from baseline to initial follow-up .


Secondary outcomes included change in headache severity , duration , self-efficacy , perceived stress , migraine-related disability/impact , anxiety , depression , mindfulness , and quality of life from baseline to initial follow-up .


MBSR was safe ( no adverse events ) , with 0 % dropout and excellent adherence ( daily meditation average : 3411 minutes , range 16-50 minutes/day ) .


Median class attendance from 9 classes ( including retreat day ) was 8 ( range [ 3 , 9 ] ) ; average class attendance was 6.7 2.5 .


MBSR participants had 1.4 fewer migraines/month ( MBSR : 3.5 to 1.0 vs control : 1.2 to 0 migraines/month , 95 % confidence interval CI [ -4.6 , 1.8 ] , P = .38 ) , an effect that did not reach statistical significance in this pilot sample .


Headaches were less severe , although not significantly so ( -1.3 points/headache on 0-10 scale , [ -2.3 , 0.09 ] , P = .053 ) and shorter ( -2.9 hours/headache , [ -4.6 , -0.02 ] , P = .043 ) vs control .


Migraine Disability Assessment and Headache Impact Test-6 dropped in MBSR vs control ( -12.6 , [ -22.0 , -1.0 ] , P = .017 and -4.8 , [ -11.0 , -1.0 ] , P = .043 , respectively ) .


Self-efficacy and mindfulness improved in MBSR vs control ( 13.2 [ 1.0 , 30.0 ] , P = .035 and 13.1 [ 3.0 , 26.0 ] , P = .035 respectively ) .


MBSR is safe and feasible for adults with migraines .


Although the small sample size of this pilot trial did not provide power to detect statistically significant changes in migraine frequency or severity , secondary outcomes demonstrated this intervention had a beneficial effect on headache duration , disability , self-efficacy , and mindfulness .


Future studies with larger sample sizes are warranted to further evaluate this intervention for adults with migraines .


This study was prospectively registered ( ClinicalTrials.gov identifier NCT01545466 ) .


To evaluate the possible advantages of combination therapy with diquafosol tetrasodium and sodium hyaluronate for dry eye after laser in situ keratomileusis ( LASIK ) .


Prospective randomized comparative trial .


A total of 206 eyes of 105 patients who underwent LASIK were enrolled in this study .


Patients were randomly assigned to 1 of 4 treatment groups according to the postoperative treatment : artificial tears , sodium hyaluronate , diquafosol tetrasodium , and a combination of hyaluronate and diquafosol .


Questionnaire responses reflecting subjective dry eye symptoms , uncorrected and corrected visual acuity , functional visual acuity , manifest refraction , tear break-up time , fluorescein corneal staining , Schirmer test , and corneal sensitivity were examined before and 1 week and 1 month after LASIK .


Distance uncorrected visual acuity was significantly better in the combination group than in the hyaluronate group 1 week and 1 month after LASIK .


Near uncorrected visual acuity was significantly better in the combination group than in the artificial tear and diquafosol groups 1 week and 1 month after LASIK .


Distance functional visual acuity improved significantly only in the combination group 1 month after LASIK .


The Schirmer value in the combination group was significantly higher than that in the hyaluronate group at 1 month after LASIK .


Subjective dry eye symptoms in the combination group improved significantly compared with those in the other groups 1 week after surgery .


Our results suggest that hyaluronate and diquafosol combination therapy is beneficial for early stabilization of visual performance and improvement of subjective dry eye symptoms in patients after LASIK .


Management of Type 1 diabetes comes with substantial personal and psychological demands particularly during adolescence , placing young people at significant risk for mental health problems .


Supportive parenting can mitigate these risks , however the challenges associated with parenting a child with a chronic illness can interfere with a parent 's capacity to parent effectively .


Interventions that provide support for both the adolescent and their parents are needed to prevent mental health problems in adolescents ; to support positive parent-adolescent relationships ; and to empower young people to better self-manage their illness .


This paper presents the research protocol for a study evaluating the efficacy of the Nothing Ventured Nothing Gained online adolescent and parenting intervention which aims to improve the mental health outcomes of adolescents with Type 1 diabetes .


A randomized controlled trial using repeated measures with two arms ( intervention and wait-list control ) will be used to evaluate the efficacy and acceptability of the online intervention .


Approximately 120 adolescents with Type 1 diabetes , aged 13-18 years and one of their parents/guardians will be recruited from pediatric diabetes clinics across Victoria , Australia .


Participants will be randomized to receive the intervention immediately or to wait 6 months before accessing the intervention .


Adolescent , parent and family outcomes will be assessed via self-report questionnaires at three time points ( baseline , 6 weeks and 6 months ) .


The primary outcome is improved adolescent mental health ( depression and anxiety ) .


Secondary outcomes include adolescent behavioral ( diabetes self-management and risk taking behavior ) , psychosocial ( diabetes relevant quality of life , parent reported child well-being , self-efficacy , resilience , and perceived illness benefits and burdens ) ; metabolic ( HbA1c ) outcomes ; parent psychosocial outcomes ( negative affect and fatigue , self-efficacy , and parent experience of child illness ) ; and family outcomes ( parent and adolescent reported parent-adolescent communication , responsibility for diabetes care , diabetes related conflict ) .


Process variables including recruitment , retention , intervention completion and intervention satisfaction will also be assessed .


The results of this study will provide valuable information about the efficacy , acceptability and therefore the viability of delivering online interventions to families affected by chronic illnesses such as Type 1 diabetes .


Australian New Zealand clinical trials registry ( ANZCTR ) ; ACTRN12610000170022 .


The aim of this study was to investigate the effects of piribedil on vigilance and cognitive performance in patients with Parkinson disease experiencing excessive daytime sleepiness on pramipexole or ropinirole .


In this 11-week randomized , active-controlled , rater-blinded phase III study , eligible patients were randomly assigned to either receive piribedil or to continue on pramipexole or ropinirole .


The primary outcome was the median reaction times during the second 15 minutes of the subtest `` vigilance '' of the Test battery for Attention Performances ( TAP ) .


Secondary outcomes included the Epworth Sleepiness Scale , Unified Parkinson 's Disease Rating Scale , neuropsychological testing , and items of the Clinical Global Impression .


Forty-four patients received piribedil ; 36 continued on either pramipexole or ropinirole .


There was no difference in the primary end point reaction time of the TAP subtest vigilance between piribedil and the comparator ( 996 vs 954 milliseconds , P = 0.68 ) .


Piribedil reduced daytime sleepiness with lower Epworth Sleepiness Scale scores at the end of treatment compared with the comparator ( -4 vs -2 points ; P = 0.01 ) .


The median Unified Parkinson 's Disease Rating Scale III score at the end of treatment was comparable between the 2 groups .


Neuropsychological tests revealed no significant between-treatment differences .


A higher therapeutic effect and global improvement were shown by the Clinical Global Impression of piribedil-treated patients .


This study shows that switching from pramipexole or ropinirole to piribedil has no effect on the reaction time of the TAP subtest vigilance but upholds the same therapeutic motor effect and reduces daytime sleepiness to a clinically relevant degree in patients with excessive daytime sleepiness .


A fractional erbium-doped glass 1,550-nm and a fractional bipolar radiofrequency ( RF ) device are effective in the treatment of atrophic acne scars .


To compare the clinical effectiveness and side effects of fractional bipolar RF with those of fractional erbium-doped glass in atrophic acne scars treatment .


Twenty Thai subjects with atrophic acne scars received three split-face monthly treatments , one side with fractional bipolar RF and the other with fractional erbium-doped glass .


Three independent physicians and patients evaluated improvement in acne scars 4weeks after the last treatment .


Side effects were also recorded after each treatment .


The study found significant improvement in acne scars after treatment with fractional bipolar RF and with a fractional erbium-doped glass device without a statistically significant difference between the two devices .


The side effects of both devices were pain , transient facial erythema , and scab formation .


The pain score with fractional erbium-doped glass was higher than that with fractional bipolar RF , but duration of scab shedding was shorter .


One case had postinflammatory hyperpigmentation on only the side treated with fractional erbium-doped glass .


Fractional bipolar RF and fractional erbium-doped glass have similar effectiveness for the treatment of atrophic acne scars .


Levodopa-carbidopa intestinal gel ( LCIG ) is delivered continuously via intrajejunal percutaneous gastrostomy tube .


To examine long-term safety , efficacy and quality of life of LCIG in an open-label extension study .


Patients received 52 weeks of open-label LCIG treatment following a 12-week double-blind , double-dummy trial in which they were randomized to either LCIG or immediate-release oral levodopa-carbidopa .


Patient cohort designation was by receipt of LCIG in the preceding trial randomization ( continuing-LCIG vs. LCIG-nave patients ) .


Sixty-two of 66 subjects in the double-blind proceeded to the open-label extension .


Most subjects ( 95 % ) reported 1 adverse event ( AE ) ; only 3 subjects ( 4.8 % ) discontinued due to AEs .


AE incidence declined gradually over 52 weeks .


Serious AEs were reported by 23 % .


LCIG-nave patients ( N = 29 ) showed a decrease in `` Off '' time and an increase in `` On '' time without troublesome dyskinesia ( change from baseline to final visit in mean [ SD ] hours = -2.34 [ 2.78 ] P < 0.001 and 2.19 [ 3.70 ] P = 0.005 , respectively ) , while continuing-LCIG patients ( N = 33 ) showed sustained `` Off '' time duration and further improvement in `` On '' time without troublesome dyskinesia ( -0.42 [ 2.67 ] P = 0.377 and 1.00 [ 2.58 ] P = 0.036 , respectively ) .


The majority of patients in both groups ( LCIG-nave , continuing-LCIG , respectively ) were rated ` Much Improved ' or ` Very Much Improved ' at final visit on the Clinical Global Impression-Improvement scale ( 69.0 % , 69.7 % ) .


Continuing-LCIG patients continued to derive benefit from LCIG while the magnitude of improvement among LCIG-nave patients was similar to that observed for patients on LCIG in the preceding double-blind study .


The overall AE profile was consistent with previous phase 3 clinical trials involving the LCIG system .


The clinical epidemiology of acanthosis nigricans ( AN ) has not been entirely studied .


Most studies mention only its prevalence taking any `` typical site '' as a whole .


These studies were carried out at different ages , races , anthropometries , and skin phototypes without analyzing the comparative clinical connotation of different sites .


Furthermore , it has never been explored as a potential early expression of insulin resistance before it becomes clinically evident .


The objective was to determine the prevalence and body distribution of AN in easy-access sites to physical examination in a Latin American youth population and its clinical implications as an early marker for obesity .


We conducted a prospective , cross-sectional , observational study in 703 randomly selected students .


Participants ' mean age was 19.11.68 years .


Overweight and obesity occurred in 23.6 % and 6.8 % , respectively .


3 observers blindly assessed neck , axillae , elbow and knuckles .


AN was identified in any of the examined sites in 47.8 % of the participants .


Its prevalence increased from 41 % to 86 % from normal to obese anthropometric categories .


AN occurred in 1-4 sites in 23.1 % , 10.8 % , 6.9 % and 7.1 % of cases , respectively .


The knuckles was the site with the highest prevalence of AN as an overall group ( 31.3 % ) and in the normal ( 24.9 % ) and overweight body mass index ( 46.4 % ) categories and there was a higher prevalence in the cases above the median in the normal body mass index category .


In the obese group , AN was slightly more common in the neck but all sites had a very similar high prevalence .


AN occurs with a high prevalence in Latin American youths , and its prevalence is much higher in a `` non-classical '' and ignored location where it is very easy to detect during physical examination : the knuckles .


It may also occur earlier in this location in the evolution to obesity .


The presence of AN in the knuckles in any patient , even if they have a normal body mass index , might indicate the likelihood of an early clinical manifestation of insulin resistance and metabolic consequences .


In older adults , loss of mobility due to sarcopenia is exacerbated in men with low serum T. T replacement therapy is known to increase muscle mass and strength , but the effect of weekly ( WK ) vs monthly ( MO ) administration on specific fiber types is unknown .


To determine the efficacy of WK vs MO T replacement on the size and functional capacity of individual fast and slow skeletal muscle fiber types .


Subjects were randomized into a 5-month , double-blind , placebo-controlled trial .


All subjects ( ages , 61-71 y ) were community-dwelling men who had T levels < 500 ng/dL .


Subjects were dosed weekly for 5 months , receiving continuous T ( WK , n = 5 ; 100 mg T enanthate , im injection ) , monthly cycled T ( MO , n = 7 ; alternating months of T and placebo ) , or placebo ( n = 7 ) .


Muscle biopsies of the vastus lateralis were obtained before and after treatment .


Main outcomes for individual slow and fast fibers included fiber diameter , peak force ( P0 ) , rate of tension development , maximal shortening velocity , peak power , and Ca ( 2 + ) sensitivity .


Both treatments increased fiber diameter and peak power , with WK treatment 5-fold more effective than MO in increasing type I fiber P0 .


WK effects on fiber diameter and force were 1.5-fold higher in slow fibers compared to fast fibers .


In fast type II fibers , diameter and P0 increased similarly between treatments .


The increased power was entirely due to increased fiber size and force .


In conclusion , T replacement effects were fiber-type dependent , restricted to increases in cell size , P0 , and peak power , and dependent on the paradigm selected ( WK vs MO ) .


Postoperative atrial fibrillation ( POAF ) is a common complication after cardiac surgery and predicts increased morbidity and mortality .


Identification of patients at high risk of POAF with the help of circulating biomarkers may enable early preventive treatment but data are limited , especially in contemporary surgical patients .


Plasma concentrations of N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) and high-sensitivity cardiac troponin T ( hs-cTnT ) were measured at enrollment , on the morning of cardiac surgery , at end surgery , and 2 days postsurgery in 562 patients undergoing cardiac surgery , randomized to perioperative supplementation with oral fish oil or placebo in the Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation trial ( OPERA ) .


The primary endpoint was incident POAF lasting 30 s , centrally adjudicated and confirmed electrocardiographically .


Higher levels of NT-proBNP and hs-cTnT before surgery were associated with older age , renal or cardiac dysfunction and EuroSCORE .


NT-proBNP peaked on postoperative day 2 ( 2172 [ 1238-3758 ] ng/L , median [ Q1-Q3 ] ) , while hs-cTnT peaked at the end of surgery ( 373 [ 188-660 ] ng/L ) .


Fish oil supplementation did not alter the time course of the cardiac biomarkers ( P > 0.05 ) .


Concentrations of NT-proBNP or hs-cTnT , on the morning of surgery , or changes in their level between morning of surgery and postsurgery , were not significantly associated with POAF after adjustment for clinical and surgical characteristics .


Among patients undergoing cardiac surgery , NT-proBNP and hs-cTnT are related to clinical and surgical characteristics , have different perioperative time courses but are not independently associated with risk of POAF .


To evaluate whether myo-inositol supplementation , an insulin sensitizer , reduces the rate of gestational diabetes mellitus ( GDM ) and lowers insulin resistance in obese pregnant women .


In an open-label , randomized trial , myo-inositol ( 2 g plus 200 micrograms folic acid twice a day ) or placebo ( 200 micrograms folic acid twice a day ) was administered from the first trimester to delivery in pregnant obese women ( prepregnancy body mass index 30 or greater .


We calculated that 101 women in each arm would be required to demonstrate a 65 % GDM reduction in the myo-inositol group with a statistical power of 80 % ( = 0.05 ) .


The primary outcomes were the incidence of GDM and the change in insulin resistance from enrollment until the diagnostic oral glucose tolerance test .


From January 2011 to April 2014 , 220 pregnant women at 12-13 weeks of gestation were randomized at two Italian university hospitals , 110 to myo-inositol and 110 to placebo .


Most characteristics were similar between groups .


The GDM rate was significantly reduced in the myo-inositol group compared with the control group , 14.0 % compared with 33.6 % , respectively ( P = .001 ; odds ratio 0.34 , 95 % confidence interval 0.17-0 .68 ) .


Furthermore , women treated with myo-inositol showed a significantly greater reduction in the homeostasis model assessment of insulin resistance compared with the control group , -1.03.1 compared with 0.11.8 ( P = .048 ) .


Myo-inositol supplementation , started in the first trimester , in obese pregnant women seems to reduce the incidence in GDM through a reduction of insulin resistance .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01047982 .


A major barrier to successful treatment in alcohol dependence is psychiatric comorbidity .


During treatment , the time to relapse is shorter , the drop-out rate is increased , and long-term alcohol consumption is greater for those with comorbid major depression or anxiety disorder than those with an alcohol use disorder with no comorbid mental disorder .


The treatment of alcohol dependence and psychological disorders is often the responsibility of different services , and this can hinder the treatment process .


Accordingly , there is a need for an effective integrated treatment for alcohol dependence and comorbid anxiety and/or depression .


We aim to assess the effectiveness of a specialized , integrated intervention for alcohol dependence with comorbid anxiety and/or mood disorder using a randomized design in an outpatient hospital setting .


Following a three-week stabilization period ( abstinence or significantly reduced consumption ) , participants will undergo complete formal assessment for anxiety and depression .


Those patients with a diagnosis of an anxiety and/or depressive disorder will be randomized to either 1 ) integrated intervention ( cognitive behavioral therapy ) for alcohol , anxiety , and/or depression ; or 2 ) usual counseling care for alcohol problems .


Patients will then be followed up at weeks 12 , 16 , and 24 .


The primary outcome measure is alcohol consumption ( total abstinence , time to lapse , and time to relapse ) .


Secondary outcome measures include changes in alcohol dependence severity , depression , or anxiety symptoms and changes in clinician-rated severity of anxiety and depression .


The study findings will have potential implications for clinical practice by evaluating the implementation of specialized integrated treatment for comorbid anxiety and/or depression in an alcohol outpatient service .


ClinicalTrials.gov Identifier : NCT01941693 .


To determine the efficacy of 16 hour nicotine patches among pregnant smokers , with the dose individually adjusted according to saliva cotinine levels ( potential range 10-30 mg/day ) .


Randomised , double blind , placebo controlled , parallel group , multicentre trial ( Study of Nicotine Patch in Pregnancy , SNIPP ) between October 2007 and January 2013 .


23 maternity wards in France .


476 pregnant smokers aged more than 18 years and between 12 and 20 weeks ' gestation , who smoked at least five cigarettes a day .


After exclusions , 402 women were randomised : 203 to nicotine patches and 199 to placebo patches .


Data were available on 192 live births in each group .


Nicotine and identical placebo patches were administered from quit day up to the time of delivery .


Doses were adjusted to saliva cotinine levels when smoking to yield a substitution rate of 100 % .


Participants were assessed monthly and received behavioural smoking cessation support .


The primary outcomes were complete abstinence ( self report confirmed by carbon monoxide level in expired air 8 ppm ) from quit date to delivery , and birth weight .


The secondary outcomes were point prevalence of abstinence , time to lapse ( a few puffs ) or relapse , and delivery and birth characteristics .


All data were analysed on an intention to treat basis .


Complete abstinence was achieved by 5.5 % ( n = 11 ) of women in the nicotine patch group and 5.1 % ( n = 10 ) in the placebo patch group ( odds ratio 1.08 , 95 % confidence interval 0.45 to 2.60 ) .


The median time to the first cigarette smoked after target quit day was 15 days in both groups ( interquartile range 13-18 in the nicotine patch group , 13-20 in the placebo patch group ) .


The point prevalence abstinence ranged from 8 % to 12.5 % in the nicotine patch group and 8 % to 9.5 % in the placebo patch group without statistically significant differences .


The nicotine substitution rate did not differ from 100 % , and the self reported median compliance rate was 85 % ( interquartile range 56-99 % ) in the nicotine patch group and 83 % ( 56-95 % ) in the placebo patch group , assessed at 1016 visits .


The mean birth weight was 3065 g ( SE 44 g ) in the nicotine patch group and 3015 g ( SE 44 g ) in the placebo patch group ( P = 0.41 ) .


Diastolic blood pressure was significantly higher in the nicotine patch group than in the placebo patch group .


The frequency of serious adverse events was similar between the groups , although more non-serious adverse reactions , mainly of skin , occurred in the nicotine patch group .


The nicotine patch did not increase either smoking cessation rates or birth weights despite adjustment of nicotine dose to match levels attained when smoking , and higher than usual doses .


ClinicalTrials.gov NCT00507975 .


Once-daily losartan reduces BP in a dose-dependent manner and is well tolerated in hypertensive children aged 6-16 years .


This study assessed the dose-response relationship , safety , and tolerability of losartan in hypertensive children aged 6 months to 6 years .


This was a 12-week , randomized , open-label , dose-ranging study , with a 2-year extension .


Patients were randomized to losartan at the following dosages : 0.1 mg/kg per day ( low ) , 0.3 mg/kg per day ( medium ) , or 0.7 mg/kg per day ( high ) .


Losartan was titrated to the next dose level ( to a 1.4 mg/kg per day maximum dosage , not exceeding 100 mg/d , which was not one of the three original doses offered at randomization ) at weeks 3 , 6 , and 9 for patients who did not attain their goal BP and were not taking the highest dose .


Dose response was evaluated by analyzing the slope of change in sitting systolic BP ( SBP ; primary end point ) and diastolic BP ( DBP ; secondary end point ) after 3 weeks compared with baseline .


Adverse events ( AEs ) were recorded throughout .


Of the 101 patients randomized , 99 were included in the analysis ( low dose , n = 32 ; medium dose , n = 34 ; and high dose , n = 33 ) .


Mean sitting BP decreased from baseline in the low - , medium - , and high-dose groups by 7.3 , 7.6 , and 6.7 mmHg , respectively , for SBP and 8.2 , 5.1 , and 6.7 mmHg , respectively , for DBP after 3 weeks .


No dose-response relationship was established by the slope analysis on SBP ( P = 0.75 ) or DBP ( P = 0.64 ) .


The BP-lowering effect was observed throughout the 2-year extension .


The incidence of AEs was low and comparable between groups .


Hypertensive children aged 6 months to 6 years treated with losartan 0.1-0 .7 mg/kg per day had clinically significant decreases from baseline in SBP and DBP , yet no dose-response relationship was evident .


Losartan , at a dosage up to 1.4 mg/kg per day , was well tolerated .


The yellow-card scheme continues to be one of the principal methods for signal generation in pharmacovigilance .


Nevertheless , under-reporting , one of its disadvantages , delays alert signals and has a negative influence on public health .


Educational interventions in pharmacovigilance may have a positive impact on the spontaneous reporting of adverse drug reactions ( ADRs ) .


To assess the duration of the effect and effectiveness of an educational intervention in pharmacovigilance designed to improve ADR reporting in a robust pharmacovigilance system .


A spatial , cluster randomized controlled trial was conducted covering all National Health System physicians in the northwest of Spain and targeting those who were actively engaged in clinical practice ( n = 7,498 ) .


Of these , 2,120 were assigned in three spatial clusters to the intervention group ( six hospitals and 138 primary care centers ) and 3,614 in four clusters to the control group ( seven hospitals and 267 primary care centers ) .


The educational intervention consisted of two complementary approaches -- one active ( group sessions ) , the other passive ( educational material , reporting form ) - implemented from November 2007 to December 2008 , with a follow-up period of 8 months .


Intervention participation was 53.7 % in a hospital setting and 60.5 % in primary care settings .


ADR reporting in the intervention group increased by 65.4 % ( 95 % confidence interval [ CI ] : 8.2-153 .4 ) across the follow-up .


The ADR reporting rate per 1,000 physicians/year in the intervention group rose from 28.1 to 39.6 following the intervention ( 51.7 and 27.4 in the first and second 4-month period , respectively ) .


For the intervention group , relative risk ( RR ) was 2.31 ( 95 % CI : 1.46-3 .68 ) and 1.04 ( 95 % CI : 0.61-1 .77 ) in the first and second 4-month period , respectively adjusted to baseline values .


There was an increase in unexpected ADR reporting ( RR 2.06 , 95 % CI 1.19-3 .55 ) .


Pharmacovigilance educational interventions that have proved effective can be successfully applied in different geographical areas .


A high baseline notification rate could account for the educational program having a moderate effect .


This 1-year randomized controlled prospective study evaluated the implant success rate and peri-implant tissue response following single immediate implant placement and provisionalization ( IIPP ) with and without subepithelial connective tissue graft ( SCTG ) in the esthetic zone .


Implants were placed either IIPP with SCTG ( test group ) or IIPP without SCTG ( control group ) .


The implants were evaluated both clinically and radiographically before surgery , immediately after implant placement , and 3 , 6 , and 12 months after implant placement .


Data were analyzed using Friedman , Wilcoxon signed-rank , and Mann-Whitney U tests at the significance level of = .05 .


Twenty implants ( 10 test , 10 control ) were placed in 20 patients ( 7 men , 13 women ) between the ages of 27 and 87 ( mean age , 52.6 years ) .


At 1 year , all implants remained osseointegrated , with overall mean marginal bone changes of -0.01 mm and -0.14 mm for the test and control groups , respectively .


Mean facial gingival level change was significantly more pronounced in the control group ( -0.70 mm ) than in the test group ( -0.25 mm ) .


The modified Plaque Index scores showed that patients were able to maintain a good level of hygiene throughout the study .


At 1 year , the Papilla Index indicated that more than 50 % papilla fill was observed in 75 % of the test sites and 80 % of the control sites .


Within the limitations of this study , SCTG was shown to be beneficial in maintaining facial gingival level when performed in conjunction with IIPP procedures .


Naltrexone , an opioid antagonist , may facilitate reduction in drinking among young adults .


We compared the efficacy and safety of naltrexone administered daily plus targeted dosing with placebo to reduce drinking in young adults who engage in heavy drinking .


A randomized , double-blind , placebo-controlled study was conducted in an outpatient research center in March 2008-January 2012 .


Participants were aged 18-25 years and reported 4 heavy drinking days in the prior 4 weeks .


Interventions included naltrexone 25 mg daily plus 25 mg targeted ( at most daily ) in anticipation of drinking ( n = 61 ) or daily/targeted placebo ( n = 67 ) .


All participants received a personalized feedback session and brief counseling every other week .


Primary outcomes were percent heavy drinking days and percent days abstinent over the 8-week treatment period .


Secondary outcomes included number of drinks per drinking day and percentage of days with estimated blood alcohol concentration ( BAC ) levels 0.08 g/dL .


Of 140 randomized patients , 128 began treatment , comprising the evaluable sample .


During treatment , percent heavy drinking days ( naltrexone : mean = 21.60 , SD = 16.05 ; placebo : mean = 22.90 , SD = 13.20 ) ( P = .58 ) and percent days abstinent ( naltrexone : mean = 56.60 , SD = 22.52 ; placebo : mean = 62.50 , SD = 15.75 ) ( P = .39 ) did not differ by group .


Naltrexone significantly reduced the number of drinks per drinking day ( naltrexone : mean = 4.90 , SD = 2.28 ; placebo : mean = 5.90 , SD = 2.51 ) ( P = .009 ) and percentage of drinking days with estimated BAC 0.08 g/dL ( naltrexone : mean = 35.4 , SD = 28.40 ; placebo : mean = 45.7 , SD = 26.80 ) ( P = .042 ) .


There were no serious adverse events .


Sleepiness was more common with naltrexone .


Naltrexone did not reduce frequency of drinking or heavy drinking days , but reduced secondary measures of drinking intensity .


While effects were modest , the risk-benefit ratio favors offering naltrexone to help young adult heavy drinkers reduce the amount of alcohol they drink .


ClinicalTrials.gov identifier : NCT00568958 .


Neointimal hyperplasia secondary to vascular smooth muscle cell ( VSMC ) activation limits the long-term patency of saphenous vein grafts ( SVGs ) .


We compared markers of vascular injury and VSMC activation in SVGs harvested using the pedicled ` no-touch ' ( NT ) vs the conventional ( CON ) technique .


Patients undergoing coronary artery bypass surgery were enrolled in the PATENT SVG trial ( clinicaltrials.gov NCT01488084 ) .


Patients were randomly allocated to have SVGs harvested with the NT technique from one leg and the CON method from the other .


SVG segments underwent morphometry , histological and electron microscopy assessments and transcript measurements of VSMC activation and differentiation markers .


Leg wound functional recovery and harvest site complications were assessed using a quality-of-life questionnaire .


A total of 17 patients ( 65.3 7.3 years ) were enrolled .


SVGs harvested using the NT vs CON technique exhibited preserved intimal , medial and adventitial architecture .


CON harvest was associated with greater medial Kruppel-like factor 4 transcript levels ( 0.26 0.05 vs 0.11 0.02 , P < 0.05 ) .


CON samples had significantly lower medial serum response factor ( 0.53 0.11 vs 1.44 0.50 , P < 0.05 ) and myocardin ( 0.59 0.08 vs 1.33 0.33 , P < 0.05 ) transcript levels .


MicroRNA-145 , an inhibitor of VSMC activation and differentiation , was higher in the NT vs CON samples ( 1.84 1.03 vs 0.50 0.19 , P < 0.05 ) .


Leg assessment scores were worse in the NT legs at 3 months , but similar to CON scores at 12 months .


SVGs harvested using the ` NT ' technique exhibit an early molecular and morphological pattern consistent with decreased VSMC activation compared with CON harvesting .


Functional leg recovery was similar in both groups at 12 months .


Larger studies are required to corroborate these findings .


The standard technique for the placement of ventricular catheters ( VC ) comprises a high proportion of malpositioning of the catheter ( 12.5 to 40 % ) .


Technical advances such as neuronavigation or ultrasound have been shown to increase the accuracy of the procedure .


Since these means result in significant technical and time consuming efforts , they are used for selected cases only .


In order to simplify the controlled placement of ventricular catheters a newly developed smartphone assisted guiding tool has been introduced .


In this study the efficacy and safety of this guiding tool is determined .


This study is a multicentre , randomised , controlled trial .


A total of 144 patients planned for an elective shunting procedure will be enrolled throughout 10 study centres within two years .


The primary objective of the trial is to show the superiority of the guided placement in comparison to the standard freehand technique of ventricular catheter application .


Patients will be followed up for 30 days after the operation in regard to image-based evaluation of the catheter position as well as possible shunt dysfunction and complications .


The Guided Application of Ventricular Catheters ( GAVCA ) trial compares the guided catheter positioning with the standard freehand technique of catheter placement in hydrocephalic patients .


If superiority is shown , the standard technique may be changed with the advantage of a more reliable and safer positioning of the ventricular catheter with just a slight effort in time and pre-operative planning .


The GAVCA trial is registered at ClinicalTrials.gov under the number NCT01811589 .


Angiotensin type 1 receptor ( AT 1 R ) antagonists are extensively used for blood pressure control in elderly patients with hypertension .


This study aimed to investigate the inhibitory effects of AT 1 R antagonist valsartan on platelet aggregation and the occurrence of cardio-cerebral thrombotic events in elderly patients with hypertension .


Two-hundred and ten patients with hypertension and aged > 60 years were randomized to valsartan ( n = 140 ) or amlodipine ( n = 70 ) on admission .


The primary endpoint was platelet aggregation rate ( PAR ) induced by arachidonic acid at discharge , and the secondary endpoint was the rate of thrombotic events including brain infarction and myocardial infarction during follow-up .


Human aortic endothelial cells ( HAECs ) were stimulated by angiotensin II ( Ang II , 100 nmol/L ) with or without pretreatment of valsartan ( 100 nmol/L ) , and relative expression of cyclooxygenase-2 ( COX-2 ) and thromboxane B 2 ( TXB 2 ) and both p38 mitogen-activated protein kinase ( p38MAPK ) and nuclear factor-kB ( NF-kB ) activities were assessed .


Statistical analyses were performed by GraphPad Prism 5.0 software ( GraphPad Software , Inc. , California , USA ) .


PAR was lower after treatment with valsartan ( 11.49 0.69 % vs. 18.71 2.47 % , P < 0.001 ) , associated with more reduced plasma levels of COX-2 ( 76.94 7.07 U/L vs. 116.4 15.89 U/L , P < 0.001 ) and TXB 2 ( 1667 56.50 pg/ml vs. 2207 180.20 pg/ml ) ( all P < 0.001 ) .


Plasma COX-2 and TXB 2 levels correlated significantly with PAR in overall patients ( r = 0.109 , P < 0.001 ) .


During follow-up ( median , 18 months ) , there was a significantly lower thrombotic event rate in patients treated with valsartan ( 14.3 % vs. 32.8 % , P = 0.002 ) .


Relative expression of COX-2 and secretion of TXB 2 with concordant phosphorylation of p38MAPK and NF-kB were increased in HAECs when stimulated by Ang II ( 100 nmol/L ) but were significantly decreased by valsartan pretreatment ( 100 nmol/L ) .


AT 1 R antagonist valsartan decreases platelet activity by attenuating COX-2 / TXA 2 expression through p38MAPK and NF-kB pathways and reduces the occurrence of cardio-cerebral thrombotic events in elderly patients with hypertension .


Women with primary ovarian insufficiency ( POI ) display low androgen levels , which could contribute to mood and behavioral symptoms observed in this condition .


We examined the effects of physiologic testosterone therapy added to standard estrogen/progestin therapy on quality of life , self-esteem , and mood in women with POI .


One hundred twenty-eight women with 46 , XX spontaneous POI participated in a 12-month randomized , placebo-controlled , parallel-design investigation of the efficacy of testosterone augmentation of estrogen/progestin therapy .


Quality of life , self-esteem , and mood symptoms were evaluated with standardized rating scales and a structured clinical interview .


Differences in outcome measures between the testosterone and placebo treatments were analyzed by Wilcoxon rank sum tests .


No differences in baseline characteristics , including serum hormone levels ( P > 0.05 ) , were found .


Baseline mean ( SD ) Center for Epidemiologic Studies Depression Scale scores were 10.7 ( 8.6 ) and 9.2 ( 7.8 ) for testosterone and placebo , respectively ( P = 0.35 ) .


After 12 months of treatment , measures of quality of life , self-esteem , and mood symptoms did not differ between treatment groups .


Serum testosterone levels achieved physiologic levels in the testosterone group and were significantly higher compared with placebo ( P < 0.001 ) .


Baseline testosterone levels were not associated with either adverse or beneficial clinical effects .


A 150-g testosterone patch achieves physiologic hormone levels in women with POI .


Our findings suggest that augmentation of standard estrogen/progestin therapy with physiologic testosterone therapy in young women with POI neither aggravates nor improves baseline reports of quality of life or self-esteem and had minimal effects on mood .


Other mechanisms might play a role in the altered mood accompanying this disorder .


Hospitalists have been shown to lower patient costs through better resource utilization and decreased length of stay , but it is unclear whether hospitalists are associated with quality of care .


We examined the association between the presence of hospitalists and 30-day predicted excess all-cause hospital mortality and readmissions among Medicare patients admitted to a hospital with any of 3 conditions : heart failure , acute myocardial infarction , and pneumonia .


Using national hospital-level , case mix-adjusted , risk-standardized , 30-day all-cause excess mortality and readmission data from the Centers for Medicare and Medicaid Services , we used descriptive and bivariate statistics to illustrate trends across hospitals .


Using multivariable ordinary least squares regression to control for hospital-level characteristics , we then estimated the association between the presence of hospitalists and predicted hospital mortality and readmission .


After multivariable adjustment , the presence of hospitalists was associated with lower probability of readmission for all 3 target conditions .


No significant associations for any of the target conditions were found in all-cause mortality models .


Hospitalists are already integral to the delivery of inpatient care at most institutions .


This study , however , showed an association at the national level of the presence of hospitalists with an important and timely quality measure : reduction of readmission rates .


Future research is indicated to explore specific causation pathways for the impact of hospitalists on quality of care .


To compare central corneal sublayer pachymetry and biomechanical properties after femtosecond lenticule extraction ( FLEX ) and small-incision lenticule extraction ( SMILE ) .


A prospective , randomized , single-masked clinical trial of 35 patients treated for moderate to high myopia with FLEX in one eye and SMILE in the other .


Anterior segment optical coherence tomography imaging ( Heidelberg Spectralis ; Heidelberg Engineering GmbH , Heidelberg , Germany ) was used to measure central corneal thickness ( CCT ) and epithelial , flap/cap , and residual stromal bed thickness centrally .


The Ocular Response Analyzer ( Reichert Ophthalmic Instruments , Buffalo , NY ) was used to assess corneal hysteresis ( CH ) and corneal resistance factor ( CRF ) .


Patients were examined before and 6 months after surgery .


Mean decrease in CCT was 105 m in FLEX-treated eyes and 106 m in SMILE-treated eyes ( P = .70 ) , which is equivalent to approximately 14 m/diopters corrected .


Mean central epithelial thickness increased 7 6 m in FLEX-treated eyes and 6 5 m in SMILE-treated eyes ( P = .64 ) .


Achieved mean flap/cap thickness was 4 6 m from the expected thickness in FLEX-treated eyes and 4 9 m in SMILE-treated eyes ( P = .37 ) .


CH was reduced 2.7 1.3 mm Hg in FLEX-treated eyes and 3.3 1.2 mm Hg in SMILE-treated eyes ( P = .08 ) .


CRF was reduced 4.5 1.2 mm Hg in FLEX-treated eyes and 4.6 1.2 mm Hg in SMILE-treated eyes ( P = .71 ) .


CH and CRF were highly correlated with CCT , but not patient age .


In this paired-eye study , the flap-based FLEX and cap-based SMILE resulted in almost identical changes in central corneal sublayer pachymetry and biomechanical properties for moderate to high myopia 6 months after treatment .


Smokers have a lower body weight compared to non-smokers .


Smoking cessation is associated with weight gain in most cases .


A hormonal mechanism of action might be implicated in weight variations related to smoking , and leptin might be implicated .


We made secondary analyses of an RCT , with a hypothesis-free exploratory approach to study the dynamic of leptin following smoking cessation .


We measured serum leptin levels among 271 sedentary smokers willing to quit who participated in a randomized controlled trial assessing a 9-week moderate-intensity physical activity intervention as an aid for smoking cessation .


We adjusted leptin for body fat levels .


We performed linear regressions to test for an association between leptin levels and the study group over time .


One year after smoking cessation , the mean serum leptin change was +3.23 mg/l ( SD 4.89 ) in the control group and +1.25 mg/l ( SD 4.86 ) in the intervention group ( p of the difference < 0.05 ) .


When adjusted for body fat levels , leptin was higher in the control group than in the intervention group ( p of the difference < 0.01 ) .


The mean weight gain was +2.91 ( SD 6.66 ) Kg in the intervention and +3.33 ( SD 4.47 ) Kg in the control groups , respectively ( p not significant ) .


Serum leptin levels significantly increased after smoking cessation , in spite of substantial weight gain .


The leptin dynamic might be different in chronic tobacco users who quit smoking , and physical activity might impact the dynamic of leptin in such a situation .


Clinical trial registration number : NCT00521391 .


Low-income black residents of Baltimore City have disproportionately higher rates of obesity and chronic disease than other Maryland residents .


Increasing the availability and affordability of healthy food are key strategies to improve the food environment and can lead to healthier diets .


This paper describes B'More Healthy : Retail Rewards ( BHRR ) , an intervention that tests the effectiveness of performance-based pricing discounts and health communications , separately and combined , on healthy food purchasing and consumption among low-income small store customers .


BHRR is 2x2 factorial design randomized controlled trial .


Fifteen regular customers recruited from each of 24 participating corner stores in Baltimore City were enrolled .


Food stores were randomized to 1 ) pricing intervention , 2 ) communications intervention , 3 ) combined intervention , or 4 ) control .


Pricing stores were given a 10-30 % price discount on selected healthier food items , such as fresh fruits , frozen vegetables , and baked chips , at the point of purchase from two food wholesale stores during the 6-month trial .


Storeowners agreed to pass on the discount to the consumer to increase demand for healthy food .


Communications stores received visual and interactive materials to promote healthy items , including signage , taste tests , and refrigerators .


Primary outcome measures include consumer food purchasing and associated psychosocial variables .


Secondary outcome measures include consumer food consumption , store sales , and associated storeowner psychosocial factors .


Process evaluation was monitored throughout the trial at wholesaler , small store , and consumer levels .


This is the first study to test the impact of performance-based pricing and communications incentives in small food stores , an innovative strategy to encourage local wholesalers and storeowners to share responsibility in creating a healthier food supply by stocking , promoting , and reducing costs of healthier foods in their stores .


Local food wholesalers were involved in a top-down , participatory approach to develop and implement an effective and sustainable program .


This study will provide evidence on the effectiveness of price incentives and health communications , separately and combined , among a low-income urban U.S.


ClinicalTrials.gov : NCT02279849 ( 2/18/2014 ) .


Loxapine , a first-generation antipsychotic , delivered with a novel inhalation delivery device developed for the acute treatment of agitation in patients with schizophrenia or bipolar disorder was evaluated in subjects with asthma or chronic obstructive pulmonary disease ( COPD ) .


Separate randomized , double-blind , parallel-arm , placebo-controlled trials compared two administrations of inhaled loxapine ( 10mg ) 10hr apart with placebo in 52 subjects with asthma and in 53 subjects with COPD .


A thermally-generated drug aerosol of loxapine was delivered to the deep lung for rapid systemic absorption .


Controller medications were continued throughout the study , but quick-relief bronchodilators were withheld from 6-8hr before through 34hr after dose 1 , unless indicated as rescue .


All airway adverse events ( AEs ) were of mild or moderate severity .


Symptomatic bronchospasm occurred in 53.8 % of subjects with asthma after inhaled loxapine and 11.5 % after placebo ; and in 19.2 % of COPD subjects after inhaled loxapine and 11.1 % after placebo .


Subjects required inhaled albuterol as follows : asthma : 53.8 % after inhaled loxapine and 11.5 % after placebo ; and COPD : 23.1 % after inhaled loxapine and 14.8 % after placebo .


Respiratory signs/symptoms requiring treatment responded to rescue bronchodilator [ forced expiratory volume in 1sec ( FEV ( 1 ) ) return to within 10 % of baseline ] within 1hr in 11 of 15 events in asthma subjects and four of seven events in COPD subjects , the remainder by the last spirometry .


In subjects with either asthma or COPD , FEV ( 1 ) decline and bronchospasm can occur following inhaled loxapine , but more frequently in asthmatic subjects .


Most subjects with bronchospasm responded to rescue bronchodilator within 1hr .


No treatment-related serious AE occurred .


Although inhaled loxapine is contraindicated in patients with active airways disease per the current approved US labeling , these studies demonstrated that rescue bronchodilator mitigated the symptomatic bronchospasms that may occur in case of inadvertent use .


Forced expiratory volume in 1s/forced expiratory volume in 6s ( FEV1/FEV6 ) assessment with a microspirometer may be useful in the diagnostic work up of subjects who are suspected of having COPD in primary care .


To determine the diagnostic accuracy of a negative pre-bronchodilator ( BD ) microspirometry test relative to a full diagnostic spirometry test in subjects in whom general practitioners ( GPs ) suspect airflow obstruction .


Cross-sectional study in which the order of microspirometry and diagnostic spirometry tests was randomised .


Study subjects were ( ex - ) smokers aged 50 years referred for diagnostic spirometry to a primary care diagnostic centre by their GPs .


A pre-BD FEV1/FEV6 value < 0.73 as measured with the PiKo-6 microspirometer was compared with a post-BD FEV1/FVC ( forced vital capacity ) < 0.70 and FEV1/FVC < lower limit of normal ( LLN ) from diagnostic spirometry .


One hundred and four subjects were analysed ( 59.6 % males , 42.3 % current smokers ) .


Negative predictive values from microspirometry for airflow obstruction based on the fixed and LLN cut-off points were 94.4 % ( 95 % confidence interval ( CI ) , 86.4-98 .5 ) and 96.3 % ( 95 % CI , 88.2-99 .3 ) , respectively .


In all , 18 % of positive microspirometry results were not confirmed by a post-BD FEV1/FVC < 0.70 and 44 % of tests were false positive compared with the LLN criterion for airflow obstruction .


Pre-bronchodilator microspirometry seems to be able to reliably preselect patients for further assessment of airflow obstruction by means of regular diagnostic spirometry .


However , use of microspirometry alone would result in overestimation of airflow obstruction and should not replace regular spirometry when diagnosing COPD in primary care .


Older patients with a distal symmetric polyneuropathy are at markedly increase risk for falls and fall-related injuries .


Despite this , few studies have investigated the effect of exercise regimens on gait and balance in this high-risk group .


One hundred older patients with distal symmetric polyneuropathy were randomized to one of three interventions : functional balance training , Tai Chi , or education-only control .


The subjects in each group received instruction in ten 1-hr weekly sessions .


Outcome measures were determined at baseline and the end of the 10-wk intervention .


Gait , balance , and falls self-efficacy were assessed with various well established clinical ( Berg Balance Scale , 8 Foot Up and Go Test , and Modified Falls Efficacy Scale ) and laboratory-based measures ( three-dimensional gait analysis and NeuroCom limits of stability and sensory organization tests ) .


The Tai Chi subjects demonstrated a decreased ( faster ) Timed Up and Go and increased stride length and time spent in single limb support at the end of intervention as compared with baseline .


The functional balance training group demonstrated a significant increase in ankle plantar flexor power and near significant decreases in step width and step width variability .


No changes in the education-only control group were observed .


Older patients with distal symmetric polyneuropathy may benefit from Tai Chi and/or functional balance training , with the former improving functional mobility and gait and the latter possibly improving trunk stabilization and forward progression ( Lythgo N , Cofr LE : Relationship between ankle plantar flexor power and EMG muscle activity during gait .


30th Annual Conference of Biomechanics in Sports [ Melbourne , 2012 ] .


Available at : https://ojs.ub.uni-konstanz.de/cap/article/viewFile/5320/4891 ) .


Whether these laudable changes can be maintained or translate into decreased risk for falls and fall-related injuries is unknown .


There are limited data on the role of antireflux biliary stents .


This single-center randomized trial compared the endoscopic use of partly covered antireflux metal stents ( pcARMS ) with that of standard uncovered self-expandable metal stents ( ucSEMS ) for the palliation of nonhilar malignant biliary obstruction .


Between August 2007 and February 2012 , patients with nonhilar malignant biliary obstruction were randomly assigned to treatment with either pcARMS or ucSEMS.Subsequent follow-up was conducted in clinic or by phone .


The primary outcome was onset of cholangitis within 12 months of stenting .


Secondary outcomes included other morbidities , stent dysfunctions , and survival .


Altogether 112 patients were included , 56 in each group.The stents were successfully deployed in all patients .


Satisfactory jaundice control was achieved in 49 cases in the pcARMS group , compared with 47 in the ucSEMS group ( P = 0.135 ) .


Fewer patients experienced cholangitis in the pcARMS group than in the ucSEMS group ( 10 vs. 21 patients ; P = 0.035 ) , and the frequency of episodes was less ( P = 0.022 ) .


Respectively , 17 and 29 stent dysfunctions before death were observed in the pcARMS and ucSEMS groups ( P = 0.051 ) and the median stent patency was 13.0 ( standard deviation [ SD ] 3.4 ) and 10.0 ( 1.2 ) months , respectively ( P = 0.044 ) .


At final follow-up , in January 2013 , 50/52 and 52/55 patients had died and no difference in median survival was seen between the two groups ( 8.0 vs. 9.0 months , P = 0.56 ) .


Stenting with pcARMS compared with standard ucSEMS reduces risk of ascending cholangitis and has longer stent patency , but does not increase patient survival .


Chictr.org .


number , ChiCTR-TRC-11001800 .


Coronary artery disease ( CAD ) is a major cause of cardiovascular morbidity and mortality in patients with diabetes mellitus , yet CAD often is asymptomatic prior to myocardial infarction ( MI ) and coronary death .


To assess whether routine screening for CAD by coronary computed tomography angiography ( CCTA ) in patients with type 1 or type 2 diabetes deemed to be at high cardiac risk followed by CCTA-directed therapy would reduce the risk of death and nonfatal coronary outcomes .


The FACTOR-64 study was a randomized clinical trial in which 900 patients with type 1 or type 2 diabetes of at least 3 to 5 years ' duration and without symptoms of CAD were recruited from 45 clinics and practices of a single health system ( Intermountain Healthcare , Utah ) , enrolled at a single-site coordinating center , and randomly assigned to CAD screening with CCTA ( n = 452 ) or to standard national guidelines-based optimal diabetes care ( n = 448 ) ( targets : glycated hemoglobin level < 7.0 % , low-density lipoprotein cholesterol level < 100 mg/dL , systolic blood pressure < 130 mm Hg ) .


All CCTA imaging was performed at the coordinating center .


Standard therapy or aggressive therapy ( targets : glycated hemoglobin level < 6.0 % , low-density lipoprotein cholesterol level < 70 mg/dL , high-density lipoprotein cholesterol level > 50 mg/dL [ women ] or > 40 mg/dL [ men ] , triglycerides level < 150 mg/dL , systolic blood pressure < 120 mm Hg ) , or aggressive therapy with invasive coronary angiography , was recommended based on CCTA findings .


Enrollment occurred between July 2007 and May 2013 , and follow-up extended to August 2014 .


The primary outcome was a composite of all-cause mortality , nonfatal MI , or unstable angina requiring hospitalization ; the secondary outcome was ischemic major adverse cardiovascular events ( composite of CAD death , nonfatal MI , or unstable angina ) .


At a mean follow-up time of 4.0 ( SD , 1.7 ) years , the primary outcome event rates were not significantly different between the CCTA and the control groups ( 6.2 % [ 28 events ] vs 7.6 % [ 34 events ] ; hazard ratio , 0.80 [ 95 % CI , 0.49-1 .32 ] ; P = .38 ) .


The incidence of the composite secondary end point of ischemic major adverse cardiovascular events also did not differ between groups ( 4.4 % [ 20 events ] vs 3.8 % [ 17 events ] ; hazard ratio , 1.15 [ 95 % CI , 0.60-2 .19 ] ; P = .68 ) .


Among asymptomatic patients with type 1 or type 2 diabetes , use of CCTA to screen for CAD did not reduce the composite rate of all-cause mortality , nonfatal MI , or unstable angina requiring hospitalization at 4 years .


These findings do not support CCTA screening in this population .


clinicaltrials.gov Identifier : NCT00488033 .


Using the Oslo Study of 1972-1973 , we wished to compare the long-term mortality pattern up to 40 years , in both the healthy cardiovascular groups at supposedly high and low risk , and in some groups having cardiovascular disease at screening .


At the screening , 16,203 ( 63 % of those invited ) men aged 40-49 years participated .


Study groups were identified by means of questionnaires regarding diseases , blood pressure and measurements of total cholesterol , triglycerides and glucose .


We identified six groups : very high cholesterol , very high blood pressure , very high glucose , non-smoking with non-elevated such risk factors , from a randomized diet and antismoking trial , and a randomized drug treatment in mild-to-moderate hypertension .


Statistical analyses were by Cox regression analysis , with Kaplan-Meier graphs .


The supposedly low-risk group had a total mortality of one-third of other groups , such as : men with hypertension , diabetes or hypercholesterolemia , or those whom participated in the two trials .


Between these latter groups , we found 2-5 years of difference in their median survival time , but their absolute risk stayed at rather high levels through all the years , with the median remaining a lifetime that was 3-8 years shorter than the men whom were free of known cardiovascular disease , diabetes or hypertension .


The long-term preventive effects on total mortality seem large , if the levels of the classical risk factors of blood pressure , total cholesterol and glucose can be adequately controlled , concurrently with a non-smoking behavior .


The study indicated that non-smoking and a low total cholesterol value were the most important contributors to extended survival .


Shortening the course of treatment for tuberculosis would be a major improvement for case management and disease control .


This phase 3 trial assessed the efficacy and safety of a 4-month gatifloxacin-containing regimen for treating rifampin-sensitive pulmonary tuberculosis .


We conducted a noninferiority , randomized , open-label , controlled trial involving patients 18 to 65 years of age with smear-positive , rifampin-sensitive , newly diagnosed pulmonary tuberculosis in five sub-Saharan African countries .


A standard 6-month regimen that included ethambutol during the 2-month intensive phase was compared with a 4-month regimen in which gatifloxacin ( 400 mg per day ) was substituted for ethambutol during the intensive phase and was continued , along with rifampin and isoniazid , during the continuation phase .


The primary efficacy end point was an unfavorable outcome ( treatment failure , recurrence , or death or study dropout during treatment ) measured 24 months after the end of treatment , with a noninferiority margin of 6 percentage points , adjusted for country .


A total of 1836 patients were assigned to the 4-month regimen ( experimental group ) or the standard regimen ( control group ) .


Baseline characteristics were well balanced between the groups .


At 24 months after the end of treatment , the adjusted difference in the risk of an unfavorable outcome ( experimental group [ 21.0 % ] minus control group [ 17.2 % ] ) in the modified intention-to-treat population ( 1356 patients ) was 3.5 percentage points ( 95 % confidence interval , -0.7 to 7.7 ) .


There was heterogeneity across countries ( P = 0.02 for interaction , with differences in the rate of an unfavorable outcome ranging from -5.4 percentage points in Guinea to 12.3 percentage points in Senegal ) and in baseline cavitary status ( P = 0.04 for interaction ) and body-mass index ( P = 0.10 for interaction ) .


The standard regimen , as compared with the 4-month regimen , was associated with a higher dropout rate during treatment ( 5.0 % vs. 2.7 % ) and more treatment failures ( 2.4 % vs. 1.7 % ) but fewer recurrences ( 7.1 % vs. 14.6 % ) .


There was no evidence of increased risks of prolongation of the QT interval or dysglycemia with the 4-month regimen .


Noninferiority of the 4-month regimen to the standard regimen with respect to the primary efficacy end point was not shown .


( Funded by the Special Program for Research and Training in Tropical Diseases and others ; ClinicalTrials.gov number , NCT00216385 . )


Malaria infections are the leading cause of death for children in Madagascar .


Insecticide-treated bednets offer effective prevention , but it is unclear how well free bednet distribution programs reach young children .


We conducted a secondary analysis of a free bednet distribution program in Madagascar from 2007-2008 .


Interviews were performed at baseline and 6 months .


Principal components analysis was used to construct a wealth and malaria knowledge index .


Coverage efficiency was calculated as coverage of children per bednet owned .


Univariable and multivariable regressions were used to determine predictors of bednet use .


Bednet use , among the 560 households in the study , increased from 6 to 91 % after 6 months .


Coverage efficiency increased from 1.29 to 1.56 children covered per bednet owned .


In multivariable analysis , having a child under 5 years of age was the only variable associated with bednet use ( OR 9.10 ; p = 0.001 ) , yielding a 99 % likelihood of using a bednet ( 95 % CI 96.4 to 99.9 % ) versus 82 % ( 95 % CI 72.2 to 88.4 % ) in households without young children .


This free bednet distribution program achieved high levels of adherence after 6 months .


Household presence of children was associated with bednet use , but not household income or education , suggesting that distribution to priority groups may help overcome traditional barriers to adoption in some settings .


To assess health-related quality of life ( HRQOL ) of subjects at risk of type 2 diabetes undergoing lifestyle intervention , and predictors for improved HRQOL .


The Finnish Diabetes Risk Score was used by general practitioners to identify individuals at risk .


Low-intensity interventions with an 18-month follow-up were employed .


HRQOL was assessed using the SF-36 at baseline and compared with results from a general Norwegian population survey and further at 6 and 18 months .


Simple and multiple linear regression analyses were applied to identify predictors of changes in HRQOL of clinical importance .


Two hundred and thirteen participants ( 50 % women ; mean age : 46 years , mean body mass index : 37 ) were included : 182 returned for 18-month follow-up , of whom 172 completed the HRQOL questionnaire .


HRQOL was reduced with clinical significance compared with general Norwegians .


The mean changes in HRQOL from the baseline to the follow-up were not of clinical importance .


However , one out of three individuals achieved a moderate or large clinical improvement in HRQOL .


The best determinant for improved HRQOL was obtained for a composite , clinically significant lifestyle change , i.e. both a weight reduction of at least 5 % and an improvement in exercise capacity of at least 10 % , which was associated with an improvement in five out of the eight SF-36 domains .


Subjects at risk of type 2 diabetes report a clinically important reduction in HRQOL compared with general Norwegians .


The best predictor of improved HRQOL was a small weight loss combined with a small improvement in aerobic capacity .


The Nintendo Wii is a simple and affordable virtual therapy alternative .


It may be used at home , and it is a motivating recreational activity that provides continuous feedback .


However , studies comparing the use of the Nintendo Wii to conventional physical therapy are needed .


To compare the effect of a rehabilitation treatment using the Nintendo Wii ( NW ) with conventional physical therapy ( CPT ) to improve the sensorimotor function and quality of life for post-stroke hemiparetic patients .


The present study applied a randomized , blind , and controlled clinical trial .


In total , 30 patients with post-stroke hemiparesis were evaluated .


A total of 15 patients were randomly assigned to each group .


The SF-36 quality of life and Fugl-Meyer scales were used to evaluate the patients .


After treatment , the only variable that differed between the groups was the physical functioning domain of the SF-36 in the group that received conventional physical therapy .


A significant difference was observed between both groups before and after treatment in terms of the following Fugl-Meyer scale items : passive movement and pain , motor function of the upper limbs ( ULs ) , and balance .


The CPT group also showed a significant difference with regard to their UL and lower limb ( LL ) coordination .


The SF-36 scale analysis revealed a significant difference within both groups with regard to the following domains : physical functioning , role limitation due to physical aspects , vitality , and role limitation due to emotional aspects .


The NW group also exhibited a significant difference in the mental health domain .


The results indicate that both approaches improved the patients ' performance in a similar manner .


Virtual rehabilitation using the Nintendo Wii and CPT both effectively treat post-stroke hemiparetic patients by improving passive movement and pain scores , motor function of the upper limb , balance , physical functioning , vitality , and the physical and emotional aspects of role functioning .


The aims were to examine the effects of psychotherapy on depressive and anxiety symptoms , the occurrence of suicidal ideations and diurnal cortisol patterns in patients with adjustment disorder ( AD ) with depressed mood .


Participants recruited from an outpatient department of psychiatry at a general hospital were randomly assigned to one of two groups : 34 in psychotherapy group and 37 in control group .


The control group consisted of one-session psychoeducation .


Psychotherapy included the eight-weekly body-mind-spirit ( BMS ) group psychotherapy .


Measures included Beck Depression Inventory-II and State Trait Anxiety Inventory .


Salivary cortisol samples were collected from the patients at their homes on awakening ; 30 and 45 min after awakening ; and at 1200 , 1700 and 2100 h. Measurements were taken at baseline and at months 2 ( end of intervention ) , 5 , 8 and 14 .


There was no differential change over time between the BMS and control groups in self-reported depression or anxiety symptoms .


However , suicidal ideation appeared to be reduced in the psychotherapy group .


Changes in diurnal cortisol patterns were also significantly different in group time interactions , in favor of BMS group .


Psychotherapy likely provides improvements in psychobiological stress responses and decreases the occurrence of suicidal ideation in patients with AD .


In this paper , we review the results of existing statistical models of the long-term persistence of hepatitis A vaccine-induced antibodies in light of recently available immunogenicity data from 2 clinical trials ( up to 17 years of follow-up ) .


Healthy adult volunteers monitored annually for 17 years after the administration of the first vaccine dose in 2 double-blind , randomized clinical trials were included in this analysis .


Vaccination in these studies was administered according to a 2-dose vaccination schedule : 0 , 12 months in study A and 0 , 6 months in study B ( NCT00289757/NCT00291876 ) .


Antibodies were measured using an in-house ELISA during the first 11 years of follow-up ; a commercially available ELISA was then used up to Year 17 of follow-up .


Long-term antibody persistence from studies A and B was estimated using statistical models for longitudinal data .


Data from studies A and B were modeled separately .


A total of 173 participants in study A and 108 participants in study B were included in the analysis .


A linear mixed model with 2 changepoints allowed all available results to be accounted for .


Predictions based on this model indicated that 98 % ( 95 % CI : 94-100 % ) of participants in study A and 97 % ( 95 % CI : 94-100 % ) of participants in study B will remain seropositive 25 years after receiving the first vaccine dose .


Other models using part of the data provided consistent results : 95 % of the participants was projected to remain seropositive for 25 years .


This analysis , using previously used and newly selected model structures , was consistent with former estimates of seropositivity rates 95 % for at least 25 years .


The ultrasonic scalpel is a surgical shear that uses high-frequency mechanical energy to enable simultaneous vessel sealing and tissue coagulation at the same time .


We conducted a prospective study to compare the outcome of total thyroidectomy using the ultrasonic scalpel versus the device Ligasure in terms of safety , operative time , overall drainage volume , complications , hospital stay .


Between January 2008 and December 2013,400 patients ( 260 women , 140 men ; mean age 46 years ) undergoing thyroidectomy were randomized into two groups : group A , where Ultracision were used , and group B , where the Ligasure device was used .


There was no significant differences between the two groups in terms of age , gender , indication for thyroidectomy , thyroid gland weight and diameter , histopathologic diagnosis , preoperative and postoperative serum calcium levels , postoperative complications and reoperative thyroid surgery , time of operation and amount of drainage .


The ultrasonic scalpel and the Ligasure ares safe , effective , useful , and time-saving alternative to the traditional suture ligation technique for thyroid surgery .


They simplified total thyroidectomy , eliminating the need for clamp-and-tie maneuvers while achieving efficient hemostasis .


To determine the effect of topical intranasal oxymetazoline on nasal resistance and aerobic exercise performance in patients with nasal congestion caused by inferior turbinate hypertrophy .


Individual randomized controlled trial .


Eight patients with inferior turbinate hypertrophy performed a set of exercise tests to exhaustion 1 week apart .


They were given oxymetazoline or a placebo before each of the two test sessions according to a random pattern .


Changes in nasal airflow were measured as peak nasal flow and ventilatory efficiency parameters , ventilatory equivalents , end-expiratory pressure , oxygen consumption , cardiac efficiency , rate of perceived exertion , and maximal and submaximal mechanical power .


Ten minutes after use of the drug or placebo , improvements in maximum nasal airflow were seen in the oxymetazoline group ( P < 0.05 ) .


However , exercise tests showed improvements in both groups ( P < 0.05 ) .


After exertion , there was no difference between the two groups in maximum nasal airflow ( P > 0.05 ) .


There were no differences between groups in oxygen consumption , rate of perceived exertion , respiratory exchange ratio , ventilation , or ventilatory equivalents for oxygen .


Oxymetazoline increased nasal airflow in patients with turbinate hypertrophy , but this change did not translate into gains in physical exercise parameters or perceived exertion .


1b .


Fibrous dysplasia ( FD ) is a rare skeletal disorder , resulting in deformity , fracture , functional impairment , and pain .


Bisphosphonates have been advocated as a potential treatment .


To determine the efficacy of alendronate for treatment of FD .


Two-year randomized , double-blind , placebo-controlled trial .


Clinical research center .


Forty subjects with polyostotic FD ( 24 adults , 16 children ) .


Subjects were randomized and stratified by age .


Study drug was administered over a 24 month period in 6 month cycles ( 6 months on , 6 months off ) .


Alendronate dosing was stratified : 40 mg daily for subjects > 50 kg , 20 mg for 30-50 kg , 10 mg for 20-30 kg .


Primary endpoints were bone turnover markers , including serum osteocalcin , and urinary NTX-telopeptides .


Secondary endpoints included areal bone mineral density ( aBMD ) , pain , skeletal disease burden score , and functional parameters including the 9-min walk test and manual muscle testing .


Clinical data was collected on 35 subjects who completed the study .


There was a decline in NTX-telopeptides in the alendronate group ( P = .006 ) , but no significant difference in osteocalcin between groups .


The alendronate group had an increase in areal BMD in normal bone at the lumbar spine ( P = .006 ) , and in predetermined regions of FD ( P < .001 ) .


There were no significant differences in pain scores , skeletal disease burden scores , or functional parameters between the groups .


Alendronate treatment led to a reduction in the bone resorption marker NTX-telopeptides , and improvement in aBMD , but no significant effect on serum osteocalcin , pain , or functional parameters .


The optimal postoperative analgesia after primary total hip arthroplasty remains in question .


This randomized , double-blind , placebo-controlled study compared the use of patient-controlled epidural analgesia ( PCEA ) with use of a multimodal pain regimen including periarticular injection ( PAI ) .


We hypothesized that PAI would lead to earlier readiness for discharge , decreased opioid consumption , and lower pain scores .


Forty-one patients received PAI , and forty-three patients received PCEA .


Preoperatively , both groups were administered dexamethasone ( 6 mg , orally ) .


The PAI group received a clonidine patch and sustained-release oxycodone ( 10 mg ) , while the PCEA group had placebo .


Both groups received combined spinal-epidural anesthesia and used an epidural pain pump postoperatively ; the PAI group had normal saline solution , while the PCEA group had bupivacaine and hydromorphone .


The primary outcome , readiness for discharge , required the discontinuation of the epidural , a pain score of < 4 ( numeric rating scale ) without parenteral narcotics , normal eating , minimal nausea , urination without a catheter , a dry surgical wound , no acute medical problems , and the ability to independently transfer and walk 12.2 m ( 40 ft ) .


The mean time to readiness for discharge ( and standard deviation ) was 2.4 0.7 days ( PAI ) compared with 2.3 0.8 days ( PCEA ) ( p = 0.86 ) .


The mean length of stay was 3.0 0.8 days ( PAI ) compared with 3.1 0.7 days ( PCEA ) ( p = 0.46 ) .


A significant mean difference in pain score of 0.74 with ambulation ( p = 0.01 ; 95 % confidence interval [ CI ] , 0.18 to 1.31 ) and 0.80 during physical therapy ( p = 0.03 ; 95 % CI , 0.09 to 1.51 ) favored the PCEA group .


The mean opioid consumption ( oral morphine equivalents in milligrams ) was significantly higher in the PAI group on postoperative day 0 ( 43 21 compared with 28 23 ; p = 0.002 ) and postoperative days 0 through 2 ( 136 59 compared with 90 79 ; p = 0.004 ) .


Opioid-Related Symptom Distress Scale ( ORSDS ) composite scores for severity and bothersomeness as well as scores for nausea , vomiting , and itchiness were significantly higher in the PCEA group ( p < 0.05 ) .


Quality of Recovery-40 scores and patient satisfaction were similar .


PAI did not decrease the time to discharge and was associated with higher pain scores and greater opioid consumption but lower ORSDS scores compared with PCEA .


The choice for analgesic regimen may depend on a particular patient 's threshold for pain and the potential side effects .


Benefits of the skeletonized internal thoracic artery ( ITA ) include increased graft flow , increased graft length , and reduced incidence of sternal complications .


We conducted a randomized , double-blinded comparison of skeletonized versus pedicled ITA to assess the differences in pain intensity and extent of disability between the two types of harvesting procedures at one and three months follow-up .


A total of 50 patients were included in our study .


Twenty-five patients had undergone skeletonized grafting while the other half had undergone pedicled grafting .


The patients were evaluated for their pain at one and three months postoperatively .


Extent of disability was measured via Pain Disability Index and intensity of pain was measured via Visual Analogue Scale ( VAS ) .


The patients were also questioned about the details of their pain using Short Form McGill Pain Questionnaire .


In the first month , the mean pain intensity measured through VAS was 30.44.0 and 55.05.7 mm in skeletonized and pedicle group , respectively .


The pedicled group had significantly higher scores measured by all three scales at both one - and three-month intervals ( p-values < 0.0001 ) .