The efficacy and adverse reactions were compared between the two groups .


The total effective rates were 40.0 % ( 10/25 ) , 64.0 % ( 16/25 ) and 76.0 % ( 19/25 ) in the observation group and were 59.1 % ( 13/22 ) , 68.2 % ( 15/22 ) and 77.3 % ( 17/22 ) in the control group in 30 days , 60 days and 90 days after treatment respectively .


The effect in 30 days after treatment in the control group was better than that in the observation group ( P < 0.05 ) .


The differences at the other time points were not significant between the two groups ( all P > 0.05 ) .


The tic time , tic frequency and tic severity score at the each time point after treatment were reduced obviously as compared with those before treatment ( all P < 0.05 ) .


Each item score in the control group was reduced obviously as compared with that in the observation group in 30 days after treatment ( all P < 0.05 ) .


The probability of adverse reaction in the observation group was less than that in the control group .


The integrated therapy of acupuncture and medicine achieves the similar effect on infantile Tourette syndrome to haloperidol tablets and the side effects of it are less .


Faldaprevir is a potent , once-daily hepatitis C virus ( HCV ) NS3/4A protease inhibitor .


STARTVerso4 assessed the efficacy and safety of faldaprevir and response-guided pegylated interferon -2 a/ribavirin ( PegIFN/RBV ) in individuals with HCV/HIV co-infection .


A phase 3 open-label study ( NCT01399619 ) .


Individuals ( N = 308 ) co-infected with HCV genotype 1 ( treatment-naive or prior interferon relapsers ) and HIV [ 96 % on antiretroviral therapy ( ART ) ] received faldaprevir 120mg ( N = 123 ) or 240mg ( N = 185 ) and PegIFN/RBV .


Those receiving a protease inhibitor or efavirenz ART were assigned to faldaprevir 120 or 240mg , respectively .


Individuals achieving early treatment success ( ETS ; HCV RNA < 25IU/ml at week 4 and undetectable at week 8 ) were randomized to 24 or 48 weeks of PegIFN/RBV .


The primary endpoint was sustained virologic response 12 weeks after treatment ( SVR12 ) .


SVR12 was achieved in 221 ( 72 % ) individuals , and the rates were comparable across faldaprevir doses .


ETS was achieved in 80 % , and of these 86 % achieved SVR12 , with comparable rates with 24 and 48 weeks of PegIFN/RBV ( 87 and 94 % , respectively ) .


In multivariate analysis , age below 40 years , IL28B CC genotype , and baseline HCV RNA below 800000IU/ml were associated with SVR12 ( P = 0.027 , P < 0.0001 , and P = 0.0002 , respectively ) , whereas treatment ( ART regimen and faldaprevir dose ) , liver cirrhosis , and genotype 1 subtype were not .


The safety profile was comparable to that of faldaprevir in HCV-monoinfected individuals .


High SVR12 rates were achieved with faldaprevir and PegIFN/RBV in HIV/HCV co-infected individuals , regardless of faldaprevir dose and background ART , HCV genotype 1 subtype , or cirrhosis status .


SVR rates mirrored those obtained with similar regimens in HCV monoinfected individuals .


To compare the short-term clinical performance of two dual-disinfectant multipurpose disinfecting solutions ( MPDS ) when used in conjunction with two silicone hydrogel contact lenses .


Participants wore galyfilcon A and balafilcon A lenses , randomly allocated one type to each eye .


Multipurpose disinfecting solutions were double-masked and allocated using a randomized crossover design .


Lenses were presoaked overnight in the allocated MPDS , containing either polyquaternium-1 / alexidine dihydrochloride ( PQ-alexidine ) or polyquaternium-1 / myristamidopropyl dimethylamine ( PQ-MAPDA ) .


Lenses were worn daily for 4 days and disinfected with the same MPDS in which they had been soaked .


Clinical assessments occurred immediately after insertion , 2 hours after insertion , and after 2 hours of wear on day 4 .


Subjective ratings were collected at each assessment and after 6 hours of wear on days 1 to 3 .


Linear mixed models were used for statistical analysis .


Solution-induced corneal staining ( SICS ) incidence was significantly different between MPDS lens combinations ( P = 0.01 ) with PQ-MAPDA-balafilcon A showing the highest incidence ( 27.8 % ) .


The incidence of SICS was significantly higher when balafilcon A lenses were worn compared with galyfilcon A ( 19.4 % vs. 2.8 % ; P = 0.04 ) .


There was no significant difference in SICS incidence between MPDS ( PQ-alexidine = 5.6 % , PQ-MAPDA = 16.7 % ; P = 0.08 ) .


Polyquaternium-1 / alexidine dihydrochloride was associated with significantly fewer symptoms of burning/stinging ( 9.70.6 vs. 9.12.2 ; P = 0.03 ) and self-assessed redness ( 9.80.5 vs. 9.21.9 ; P = 0.03 ) on initial lens insertion .


There were no significant differences between MPDS for comfort ratings ( P > 0.05 ) .


These short-term clinical results provide an initial indication that PQ-alexidine is associated with fewer symptoms on insertion but no significant difference in ocular comfort compared with PQ-MAPDA .


Longer studies are required to provide further evidence .


Acute radiation cystitis , inflammation of the bladder , is a common side effect in men receiving external beam radiation for prostate cancer .


Although several treatments provide symptomatic relief , there is no effective treatment to prevent or treat radiation cystitis .


Cranberry products have been associated with urinary tract health .


This study aimed to determine the effect of highly standardized cranberry capsules ( containing 72 mg proanthocyanidins [ PACS ] ) compared with that of placebo capsules on the incidence and severity of radiation cystitis .


Forty-one men with prostate cancer participated in a double blinded randomized placebo controlled study .


Men took one capsule a day at breakfast during treatment and for 2 weeks after treatment completion .


Severity of urinary symptoms and the bother these caused were measured using the individual items of the urinary domain of the Modified Expanded Prostate Index Composite ( EPIC ) .


The incidence of cystitis was lower in men taking cranberry capsules ( 65 % ) compared with those that took placebo capsules ( 90 % ) ( p = 0.058 ) ; severe cystitis was seen in 30 % of men in the cranberry arm and 45 % in the placebo arm ( p = 0.30 ) .


Overall , the incidence of pain/burning was significantly lower in the cranberry cohort ( p = 0.045 ) .


Men on the low hydration regimen who took cranberry had less pain/burning ( p = 0.038 ) , stronger urine steam ( p = 0.030 ) and used significantly fewer pads/liners ( p = 0.042 ) , which was significantly different from those on the high hydration regimen ( p = 0.028 ) .


Men receiving radiation therapy for prostate cancer may benefit from using cranberry capsules , particularly those on low hydration regimens or with baseline urinary symptoms .


Endoscopic minimally invasive surgery of the cervical region is currently used to treat benign thyroid disease .


The aim of this study was to evaluate the safety , feasibility , and inflammatory response to endoscopic thyroidectomy ( ET ) via an anterior chest wall approach .


Between January 2007 and January 2012 , 320 patients underwent sub-total/total thyroidectomy .


Of these , 160 had endoscopic surgery through an anterior chest wall approach ( ET , group A ) and 160 had traditional open surgery ( group B ) .


Demographics , operation time , intraoperative blood loss , complications , hospital stay , cost , and postoperative outcomes were compared between the 2 groups .


Serum Interleukin-6 and C-reactive protein levels were measured preoperatively and at 2 , 12 , 24 , and 48 hours postoperatively .


Patient demographics , tumor size , operation time , and pathologic diagnoses were similar in both groups .


There was no difference in procedure time and postoperative complication rates .


Intraoperative blood loss and length of hospital stay were significantly lower in group A ( P < 0.05 ) , but cost was higher ( P < 0.05 ) .


Serum Interleukin-6 and C-reactive protein levels increased significantly after both procedures , with levels at the 24-hour and 48-hour time points higher in group B ( P < 0.05 ) .


Two cases in group A and 1 in group B developed a transient hoarse voice postoperatively , which recovered 7.5 days ( range , 5 to 12 d ) later .


There were no serious complications during the 2-year follow-up .


ET through an anterior chest wall approach is safe and feasible for benign thyroid disease , and offers the advantage of no visible scar .


The BELOB study , a randomised controlled phase 2 trial comparing lomustine , bevacizumab and combined lomustine and bevacizumab in patients with recurrent glioblastoma , showed that the 9-month overall survival rate was most promising in the combination arm .


Here we report the health-related quality of life ( HRQoL ) results , a secondary trial end-point .


HRQoL was measured at baseline and every 6weeks until progression using the European Organisation for Research and Treatment of Cancer ( EORTC ) core questionnaire ( QLQ-C30 ) and brain module ( QLQ-BN20 ) .


HRQoL was assessed over time for five preselected scales ( global health ( GH ) , physical ( PF ) and social functioning ( SF ) , motor dysfunction ( MD ) and communication deficit ( CD ) ) .


Moreover , mean changes in HRQoL from baseline until progression were determined .


138/148 patients with at least a baseline HRQoL assessment were analysed .


Over time , HRQoL remained relatively stable in all treatment arms for all five scales , at least during the first three treatment cycles .


More than half ( 54-61 % ) of the patients showed stable ( < 10 point change ) or improved ( 10 point change ) HRQoL during their progression-free time , except for SF ( 43 % ) , irrespective of treatment arm .


Deterioration of mean HRQoL was most profound at disease progression for all scales except SF , which deteriorated earlier in disease course .


Compared to baseline , 40 % of patients had clinically relevant ( 10 points ) worse GH , PF and SF , while 44 % and 31 % had increased MD and CD at disease progression , irrespective of treatment arm .


Bevacizumab , whether or not in combination with lomustine , did not negatively affect HRQoL in patients treated for recurrent glioblastoma in this randomised study .


To investigate the efficacy , safety , and tolerability of empagliflozin in patients with type 2 diabetes and hypertension .


Patients ( N = 825 ) with type 2 diabetes and hypertension ( mean seated systolic blood pressure [ SBP ] 130-159 mmHg and diastolic blood pressure [ DBP ] 80-99 mmHg ) were randomized ( double blind ) to 10 mg or 25 mg empagliflozin or placebo once daily for 12 weeks .


At week 12 , adjusted mean difference versus placebo in change from baseline in mean 24-h SBP ( ambulatory blood pressure monitoring [ ABPM ] ) was -3.44 mmHg ( 95 % CI -4.78 , -2.09 ) with 10 mg empagliflozin and -4.16 mmHg ( -5.50 , -2.83 ) with 25 mg empagliflozin ( both P < 0.001 ) .


At week 12 , adjusted mean difference versus placebo in change from baseline in mean 24-h DBP ( ABPM ) was -1.36 mmHg ( 95 % CI -2.15 , -0.56 ) with 10 mg empagliflozin and -1.72 mmHg ( 95 % CI -2.51 , -0.93 ) with 25 mg empagliflozin ( both P < 0.001 ) .


Changes in office BP were consistent with ABPM .


Adjusted mean difference versus placebo in change from baseline in HbA1c at week 12 was -0.62 % ( 95 % CI -0.72 , -0.52 ) ( -6.8 mmol/mol [ 95 % CI -7.9 , -5.7 ] ) with 10 mg empagliflozin and -0.65 % ( 95 % CI -0.75 , -0.55 ) ( -7.1 mmol/mol [ 95 % CI -8.2 , -6.0 ] ) with 25 mg empagliflozin ( both P < 0.001 ) .


Empagliflozin was well tolerated .


One patient on placebo and one patient on 10 mg empagliflozin reported events consistent with volume depletion .


Empagliflozin was associated with significant and clinically meaningful reductions in BP and HbA1c versus placebo and was well tolerated in patients with type 2 diabetes and hypertension .


To observe the impact on lower limbs balance function in treatment of yin-yang meridians acupuncture with respiratory reinforcing and reducing manipulation involved in the patients of stroke by applying B-PHY balance function test training system so as to provide the objective evidence in treatment of stroke ; with acupuncture .


One hundred patients were randomized into an observation group and a control group , 50 cases in each one .


In the control group , the basic treatment was applied , without other relevant rehabilitation therapies associated .


In the observation group , with the basic treatment as the control group 's , the therapy of the yin-yang meridians acupuncutre with respiratory reinforcing and reducing manipulation was adopted .


On the yin meridians , Zuwuli ( LR 10 ) , Xuehai ( SP 10 ) , Yinlingquan ( SP 9 ) , Sanyinjiao ( SP 6 ) and the others were selected and stimulated with reducing manipulation achieved by the coordination of patient 's respiration .


On the yang meridians , Biguan ( ST 31 ) , Liangqiu ( ST 34 ) , Yanglingquan ( GB 34 ) and the others were selected and stimulated with reinforcing manipulation achieved by the coordination of patient 's respiration .


The treatment was given once a day and for 28 days totally .


Before treatment and in 28 days of treatment , B-PHY balance function test training system was used to determine the weight shift track parameters ( track length , peripheral square , track length of per unit square , left-right offset and rectangle square ) , the weight shift track distance parameters [ mean of X axle weight shift distance ( Mean-X ) , mean of Y axle weight shift distance ( Mean-Y ) , maximum of X axle weight shift distance ( Max-X ) , maximum of Y axle weight shift distance ( Max-Y ) , weight shift distance ( LSKG ) , weight shift square ( SSKG ) , square ratio of weight shift ( LFS ) ] , stability coefficient ( SI ) and weight distribution coefficient ( WDI ) .


After treatment , the differences in the weight shift track parameters , SI and WDI were significant as compared with those before treatment in the patients of the two groups ( all P < 0.01 ) ; while the differences in the weight shift distance parameters in the observation group were improved obviously after treatment as compared with those before treatment ( all P < 0.01 ) , the differences of Mean-X , Max-Y and LFS in the control group were improved after treatment as compared with those before treatment ( all P < 0.01 ) .


Except SSKG , the improvements after treatment in the rest indices in the observation group were better than those in the control group ( all P < 0.05 ) .


The yin-yang meridians acupuncture with respiratry reinforcing and re - ducing manipulation effectively improves the lower limbs balance function in the patients of stroke .


Although the cause in most cases of childhood leukemia is not known , the contribution of environmental risk factors in the context of genetic predisposition has been reported with inconsistent results .


The aim of this study was to examine association of childhood leukemia with maternal factors especially during pregnancy , to help in avoiding risk factors .


This case-control study included children younger than 18 years diagnosed with leukemia from 2008 to 2012 .


Controls were randomly selected and individually matched to cases with respect to age , sex , and residency .


All variables were compared between cases and control to determine any significant association with leukemia .


Statistically significant associations between risk of childhood leukemia with mother 's education ( p = 0.001 ) , occupation ( p = 0.0005 ) and pesticides exposure ( p = 0.005 ) during pregnancy were found .


However , there were no significant links with maternal age ( p = 0.090 ) , history of fetal loss ( 0.85 ) , history of radiography during pregnancy ( p = 0.400 ) , history of drug intake ( p = 0.689 ) and infection ( p = 0.696 ) during pregnancy .


The results showed increased risk of leukemia in children whose mothers were working in agriculture and were exposed to pesticides during pregnancy .


The further study needs to be investigated to know association of various maternal risk factors with leukemia which remained unknown in this study .


Inflammatory biomarkers predict incident and recurrent cardiac events , but their relationship to stroke prognosis is uncertain .


We hypothesized that high-sensitivity C-reactive protein ( hsCRP ) predicts recurrent ischemic stroke after recent lacunar stroke .


Levels of Inflammatory Markers in the Treatment of Stroke ( LIMITS ) was an international , multicenter , prospective ancillary biomarker study nested within Secondary Prevention of Small Subcortical Strokes ( SPS3 ) , a phase III trial in patients with recent lacunar stroke .


Patients were assigned in factorial design to aspirin versus aspirin plus clopidogrel , and higher versus lower blood pressure targets .


Patients had blood samples collected at enrollment and hsCRP measured using nephelometry at a central laboratory .


Cox proportional hazard models were used to calculate hazard ratios ( HRs ) and 95 % confidence intervals ( 95 % CIs ) for recurrence risks before and after adjusting for demographics , comorbidities , and statin use .


Among 1244 patients with lacunar stroke ( mean age , 63.310.8 years ) , median hsCRP was 2.16 mg/L .


There were 83 recurrent ischemic strokes ( including 45 lacunes ) and 115 major vascular events ( stroke , myocardial infarction , and vascular death ) .


Compared with the bottom quartile , those in the top quartile ( hsCRP > 4.86 mg/L ) were at increased risk of recurrent ischemic stroke ( unadjusted HR , 2.54 ; 95 % CI , 1.30-4 .96 ) , even after adjusting for demographics and risk factors ( adjusted HR , 2.32 ; 95 % CI , 1.15-4 .68 ) .


hsCRP predicted increased risk of major vascular events ( top quartile adjusted HR , 2.04 ; 95 % CI , 1.14-3 .67 ) .


There was no interaction with randomized antiplatelet treatment .


Among recent lacunar stroke patients , hsCRP levels predict the risk of recurrent strokes and other vascular events .


hsCRP did not predict the response to dual antiplatelets .


http://www.clinicaltrials.gov .


Unique identifier : NCT00059306 .


To evaluate the effectiveness of the Healthy Directions 2 ( HD2 ) intervention in the primary care setting .


HD2 was a cluster randomized trial ( conducted 3/09-11 / 11 ) .


The primary sampling unit was provider ( n = 33 ) , with secondary sampling of patients within provider ( n = 2440 ) .


Study arms included : 1 ) usual care ( UC ) ; 2 ) HD2 -- a patient self-guided intervention targeting 5 risk behaviors ; and 3 ) HD2 plus 2 brief telephone coaching calls ( HD2 + CC ) .


The outcome measure was the proportion of participants with a lower multiple risk behavior ( MRB ) score by follow-up .


At baseline , only 4 % of the participants met all behavioral recommendations .


Both HD2 and HD2 + CC led to improvements in MRB score , relative to UC , with no differences between the two HD2 conditions .


Twenty-eight percent of the UC participants had improved MRB scores at 6 months , vs. 39 % and 43 % in HD2 and HD2 + CC , respectively ( ps .001 ) ; results were similar at 18 months ( p. 05 ) .


The incremental cost of one risk factor reduction in MRB score was $ 310 for HD2 and $ 450 for HD2 + CC .


Self-guided and coached intervention conditions had equivalent levels of effect in reducing multiple chronic disease risk factors , were relatively low cost , and thus are potentially useful for routine implementation in similar health settings .


The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis .


Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery , potentially improving vessel patency by reducing restenosis .


In this single-blind , randomized trial conducted at 54 sites , we assigned , in a 2:1 ratio , 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty .


The primary efficacy end point was primary patency of the target lesion at 12 months ( defined as freedom from binary restenosis or from the need for target-lesion revascularization ) .


The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death ( i.e. , death from a medical complication related to a limb ) , amputation , and reintervention .


The two groups were well matched at baseline ; 42.9 % of the patients had diabetes , and 34.7 % were current smokers .


At 12 months , the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty ( 65.2 % vs. 52.6 % , P = 0.02 ) .


The proportion of patients free from primary safety events was 83.9 % with the drug-coated balloon and 79.0 % with standard angioplasty ( P = 0.005 for noninferiority ) .


There were no significant between-group differences in functional outcomes or in the rates of death , amputation , thrombosis , or reintervention .


Among patients with symptomatic femoropopliteal peripheral artery disease , percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon .


The drug-coated balloon was noninferior to the standard balloon with respect to safety .


( Funded by Lutonix-Bard ; LEVANT 2 ClinicalTrials.gov number , NCT01412541 . )


The intake of whey , compared with casein and soy protein intakes , stimulates a greater acute response of muscle protein synthesis ( MPS ) to protein ingestion in rested and exercised muscle .


We characterized the dose-response relation of postabsorptive rates of myofibrillar MPS to increasing amounts of whey protein at rest and after exercise in resistance-trained , young men .


Volunteers ( n = 48 ) consumed a standardized , high-protein ( 0.54 g/kg body mass ) breakfast .


Three hours later , a bout of unilateral exercise ( 8 10 leg presses and leg extensions ; 80 % one-repetition maximum ) was performed .


Volunteers ingested 0 , 10 , 20 , or 40 g whey protein isolate immediately ( ~ 10 min ) after exercise .


Postabsorptive rates of myofibrillar MPS and whole-body rates of phenylalanine oxidation and urea production were measured over a 4-h postdrink period by continuous tracer infusion of labeled [ ( 13 ) C6 ] phenylalanine and [ ( 15 ) N2 ] urea .


Myofibrillar MPS ( mean SD ) increased ( P < 0.05 ) above 0 g whey protein ( 0.041 0.015 % / h ) by 49 % and 56 % with the ingestion of 20 and 40 g whey protein , respectively , whereas no additional stimulation was observed with 10 g whey protein ( P > 0.05 ) .


Rates of phenylalanine oxidation and urea production increased with the ingestion of 40 g whey protein .


A 20-g dose of whey protein is sufficient for the maximal stimulation of postabsorptive rates of myofibrillar MPS in rested and exercised muscle of ~ 80-kg resistance-trained , young men .


A dose of whey protein > 20 g stimulates amino acid oxidation and ureagenesis .


This trial was registered at http://www.isrctn.org/ as ISRCTN92528122 .


Dietary nitrate supplementation positively affects cardiovascular function at rest and energy metabolism during exercise in humans and has recently also been reported to markedly enhance the in vitro contractile properties of mouse fast-twitch muscle .


The aim of this study was to investigate the effects of short-term nitrate supplementation on the in vivo contractile properties of the skeletal muscle and voluntary muscle function of humans .


In a double-blind , randomized , crossover design , 19 healthy untrained men ( 21 3 yr ) ingested a nitrate-rich concentrated beetroot juice ( NIT ; nitrate dosage , approximately 9.7 mmold ) and a placebo ( PLA ) for seven consecutive days .


After the last supplementation dose , force was recorded while participants completed a series of voluntary and involuntary ( electrically evoked ) unilateral isometric contractions of the knee extensors .


NIT enhanced the peak force response to low-frequency electrical stimulation , as follows : maximal twitch ( NIT , 149 41 N , vs PLA , 138 37 N ; P = 0.008 ; effect size , r ( ES ) = 0.56 ) and submaximal 1 - to 20-Hz contractions ( 5 % -10 % , ES = 0.53-0 .63 ) .


Whereas explosive ( rising phase ) force production during the first 50 ms of evoked maximal twitch and octet contractions ( eight electrical impulses at 300 Hz ) was also 3 % -15 % greater after NIT compared with that after PLA ( P = 0.023-0 .048 , ES = 0.52-0 .59 ) , explosive voluntary force remained similar ( P = 0.510 , ES = 0.16 ) .


Maximum voluntary force was also unchanged after NIT ( P = 0.539 , ES = 0.15 ) .


These results indicate that 7 d of dietary nitrate supplementation enhanced the in vivo contractile properties of the human skeletal muscle .


Specifically , nitrate supplementation improved excitation-contraction coupling at low frequencies of stimulation and enhanced evoked explosive force production but did not affect maximum or explosive voluntary force production in untrained individuals .


It has been suggested that home-based heart failure ( HF ) management in primary care may be an alternative to clinic-based management in HF patients .


However , little is known about adherence to HF guidelines and adherence to the medication regimen in these home-based programmes .


The aim of the current study was to determine whether long-term follow-up and treatment in primary care is equally effective as follow-up at a specialized HF clinic in terms of guideline adherence and patient adherence , in HF patients initially managed and up-titrated to optimal treatment at a specialized HF clinic .


We conducted a multicentre , randomized , controlled study in 189 HF patients ( 62 % male , age 72 11 years ) , who were assigned to follow-up either in primary care ( n = 97 ) or in a HF clinic ( n = 92 ) .


After 12 months , no differences between guideline adherence , as estimated by the Guideline Adherence Indicator ( GAI-3 ) , and patient adherence , in terms of the medication possession ratio ( MPR ) , were found between treatment groups .


There was no difference in the number of deaths ( n = 12 in primary care and n = 8 in the HF clinic ; P = 0.48 ) , and hospital readmissions for cardiovascular ( CV ) reasons were also similar .


The total number of unplanned non-CV hospital readmissions , however , tended to be higher in the primary care group ( n = 22 ) than in the HF clinic group ( n = 10 ; P = 0.05 ) .


Patients discharged after initial management in a specialized HF clinic can be discharged to primary care for long-term follow-up with regard to maintaining guideline adherence and patient adherence .


However , the complexity of the HF syndrome and its associated co-morbidities requires continuous monitoring .


Close collaboration between healthcare providers will be crucial in order to provide HF patients with optimal , integrated care .


To assess the effect of a group-based intervention on the balance between necessity beliefs and concern beliefs about medication and on medication non-adherence in patients with rheumatoid arthritis ( RA ) .


Non-adherent RA patients using disease-modifying anti-rheumatic drugs ( DMARDs ) were randomized to an intervention or control arm .


The intervention consisted , amongst others , of two motivational interviewing-guided group sessions led by the same pharmacist .


Control patients received brochures about their DMARDs .


Questionnaires were completed up to 12 months follow-up .


123 patients ( mean age : 60 years , female : 69 % ) were randomized .


No differences in necessity beliefs and concern beliefs about medication and in medication non-adherence were detected between the intervention and control arm , except at 12 months ' follow-up : participants in the intervention arm had less strong necessity beliefs about medication than participants in the control arm ( b : -1.0 ( 95 % CI : -2.0 , -0.1 ) ) .


This trial did not demonstrate superiority of our intervention over the control arm in changing beliefs about medication or in improving medication adherence over time .


Absent intervention effects might have been due to , amongst others , selection bias and a suboptimal treatment integrity level .


Hence , targeting beliefs about medication in clinical practice should not yet be ruled out .


To evaluate the effects of sacral magnetic stimulation ( SMS ) on functional and urodynamic improvement in patients with refractory stress urinary incontinence ( SUI ) .


A sham-controlled , double-blind , parallel study design with a 4.5-month follow-up .


A tertiary hospital .


Women ( age , 45-75y ) with SUI refractory to first-line management ( N = 34 ) were allocated to either an experimental ( n = 20 ) group or a sham ( n = 14 ) group .


The SMS protocol consisted of 5-Hz , 20-minute treatments administered over the bilateral third sacral roots , with the intensity set at approximately 70 % of the maximal output , for 12 consecutive weekdays .


Urodynamic assessments and 2 life stress questionnaires , namely , the Urge-Urinary Distress Inventory ( U-UDI ) and the Overactive Bladder Questionnaire ( OAB-q ) , were administered pre - and post-SMS intervention .


We administered the U-UDI ( primary outcome measure ) and the OAB-q at 3-week intervals during the follow-up period until 18 weeks after the final intervention .


The experimental group exhibited significant improvements in both U-UDI and OAB-q scores postintervention ( P = .011 -.014 ) and at follow-up visits ( P < .001 -.007 ) compared with the sham group .


In addition , significant increases in bladder capacity , urethral functional length , and the pressure transmission ratio ( P = .009 -.033 ) were noted postintervention .


Multivariate regression analysis revealed that patients with more severe symptoms benefited more from SMS .


A poorer baseline U-UDI score and a shorter urethral functional length were associated with a greater response to SMS .


Our observations of a greater response to SMS in patients with more severe SUI than in those with mild symptoms , as well as the long-term benefits of the treatment , confirm the efficacy of SMS in treating SUI .


To evaluate clinical efficacy of electroacupuncture at Changqiang ( GV 1 ) and Chengshan ( BL 57 ) 30 min before surgery on postoperative pain and discomforts in patients with mixed hemorrhoids .


One hundred and twenty cases of mixed hemorrhoids who received Milligan-Morgan operation were randomly divided into an electroacupuncture group , a sham electroacupuncture group and a blank group , 40 cases in each one .


At the same time of basic treatment , the electroacupuncture was applied at Changqiang ( GV 1 ) and Chengshan ( BL 57 ) 30 min before surgery in the electroacupuncture group , while shallow needling without electrical stimulation at sham acupoint ( 1 cm next to acupoint ) was applied 30 min before surgery in the sham electroacupuncture group , while no treatment was given before the surgery in the blank group .


The total dose of painkillers in the first 24 h after operation , the number of cases who received additional anesthetic in the operation , the self-score of most severity pain in the first 24 h after operation and sleeping time in the night of surgery were observed .


The differences of the numbers of cases who received additional anesthetic in the operation had no statistical significance among the three groups ( all P > 0.05 ) , but compared with the sham electroacupuncture group and blank group , the total dose of painkillers in the first 24 h after operation was reduced in the electroacupuncture group [ ( 2.43 + / - 1.08 ) tablets vs ( 3.23 + / - 1.33 ) tablets , ( 3.10 + / - 1.22 ) tablets ] , and the score of most severity pain was also decreased ( 6.65 + / - 1.00 vs 7.48 + / - 0.96 , 7.25 + / - 1.19 ) , besides , the sleeping time in the night of surgery was increased [ ( 220.63 + / - 85.50 ) min vs ( 162.00 + / - 92.69 ) min , ( 151.50 + / - 80.01 ) min , all P < 0.05 ] .


The electroacupuncture at Changqiang ( GV 1 ) and Chengshan ( BL 57 ) 30 min before surgery has effects of preemptive analgesia on postoperative pain for patients with mixed hemorrhoids .


Evaluate the effect of intravenous fentanyl on the incidence and severity of EA .


In the clinical trial , 144 patients aged between two and nine years , scheduled for elective surgery were enrolled and randomly assigned to receive either fentanyl 1 microg/kg or normal saline 1 ml/10 kg , 15 minutes before the end of surgery .


Watcha 's behavioral emergence delirium scale was used to assess EA .


The incidence of EA was lower in the fentanyl group ( 11/72 vs. 23/72 person respectively , p = 0.03 ) .


However there was no statistically significant difference in the number of patients with severe EA ( 1/72 vs. 6/72 person respectively , p = 0.12 ) .


Fewer number of patients in the fentanyl group had moderate to severe pain when compared with the control group ( 16/72 vs. 30/72 person respectively , p = 0.02 ) .


The number of patient who required rescue analgesia was significantly lower in the fentanyl group ( 18/72 vs. 30/72 person respectively , p = 0.04 ) .


There were no statistically significant differences in terms of emergence time , postoperative adverse events , and length of stay in the post-anesthetic care unit between the two groups .


Administration of intravenous fentanyl 1 microg/kg 15 minutes prior the end of surgery decreased the incidence of EA and reduced pain without delaying emergence and without any increase in postoperative complications .


Abnormal choroidal blood flow is considered important in the pathogenesis of chronic central serous chorioretinopathy ( CSC ) .


Optical coherence tomography ( OCT ) angiography can image ocular blood cell flow and could thus provide novel insights in disease mechanisms of CSC .


We evaluated depth-resolved flow in chronic CSC by OCT angiography compared to fluorescein angiography ( FA ) and indocyanine green angiography ( ICGA ) .


Eighteen eyes with chronic CSC , and six healthy controls , were included .


Two human observers annotated areas of staining , hypofluorescence , and hotspots on FA and ICGA , and areas of abnormal flow on OCT angiography .


Interobserver agreement in annotating OCT angiography and FA/ICGA was measured by Jaccard indices ( JIs ) .


We assessed colocation of flow abnormalities and subretinal fluid visible on OCT , and the distance between hotspots on ICGA from flow abnormalities .


Abnormal areas were most frequently annotated in late-phase ICGA and choriocapillary OCT angiography , with moderately high ( median JI , 0.74 ) and moderate ( median JI , 0.52 ) interobserver agreement , respectively .


Abnormalities on late-phase ICGA and FA colocated with those on OCT angiography .


Aberrant choriocapillary OCT angiography presented as foci of reduced flow surrounded by hyperperfused areas .


Hotspots on ICGA were located near hypoperfused spots on OCT angiography ( mean distance , 168 m ) .


Areas with current or former subretinal fluid were colocated with flow abnormalities .


On OCT angiography , chronic CSC showed irregular choriocapillary flow patterns , corresponding to ICGA abnormalities .


These results suggest focal choriocapillary ischemia with surrounding hyperperfusion that may lead to subretinal fluid leakage .


Psychological therapy is effective for symptoms of mental distress , but many groups with high levels of mental distress face significant barriers in terms of access to care , as current interventions may not be sensitive to their needs or their understanding of mental health .


There is a need to develop forms of psychological therapy that are acceptable to these groups , feasible to deliver in routine settings , and clinically and cost effective .


We developed a culturally sensitive wellbeing intervention with individual , group and sign-posting elements , and tested its feasibility and acceptability for patients from ethnic minorities and older people in an exploratory randomised trial .


We recruited 57 patients ( 57 % of our target ) from 4 disadvantaged localities in the NW of England .


The results of the exploratory trial suggest that the group receiving the wellbeing interventions improved compared to the group receiving usual care .


For elders , the largest effects were on CORE-OM and PHQ-9 .


For ethnic minority patients , the largest effect was on PHQ-9 .


Qualitative data suggested that patients found the intervention acceptable , both in terms of content and delivery .


This exploratory trial provides some evidence of the efficacy and acceptability of a wellbeing intervention for older and ethnic minority groups experiencing anxiety and depression , although challenges in recruitment and engagement remain .


Evidence from our exploratory study of wellbeing interventions should inform new substantive trial designs .


Current controlled trials ISRCTN68572159 .


Brivaracetam ( BRV ) is a novel high-affinity synaptic vesicle protein 2A ligand currently being investigated for the treatment of epilepsy .


The purpose of this phase III study was to evaluate the efficacy and safety/tolerability of adjunctive BRV in adults with uncontrolled partial-onset ( focal ) seizures .


This was a prospective , multicenter , randomized , double-blind , placebo-controlled , parallel-group , fixed-dose trial ( N01253 ; NCT00464269 ) .


Adults aged 16-70 years with well-characterized partial epilepsy not fully controlled despite treatment with one or two antiepileptic drugs ( AEDs ) were enrolled .


Patients who experienced eight or more partial-onset seizures , whether or not secondarily generalized , during the 8-week prospective baseline period were randomized ( 1:1:1:1 ) to receive twice-daily placebo ( PBO ) or BRV ( 5 , 20 , or 50 mg/day ) without titration .


The primary efficacy endpoint was percent reduction over PBO in baseline-adjusted partial-onset seizure frequency/week during the 12-week treatment period .


Comparison of BRV with PBO was sequential ( 50 , 20 mg/day , then 5 mg/day ) .


Secondary endpoints included 50 % responder rate and median percent reduction from baseline in partial-onset seizure frequency/week .


Post hoc analyses included the primary efficacy endpoint evaluated over 28 days and exploratory subanalyses of efficacy by seizure subtype .


Safety and tolerability assessments included treatment-emergent adverse events ( TEAEs ) , laboratory tests , electrocardiography , vital signs , and physical and neurologic examinations .


Of 400 patients randomized , 396 were included in the intent-to-treat ( ITT ) population ( PBO n = 98 , BRV 5 mg/day n = 97 , BRV 20 mg/day n = 100 , BRV 50 mg/day n = 101 ) and 392 comprised the modified ITT ( mITT ) population .


A total of 361 ( 91.2 % ) of 396 patients completed the study .


Most patients ( 78.3 % ) were receiving two concomitant AEDs .


Percent reduction in partial-onset seizure frequency/week over PBO was -0.9 % ( p = 0.885 ) for BRV 5 mg/day , 4.1 % ( p = 0.492 ) for BRV 20 mg/day , and 12.8 % ( p = 0.025 ) for BRV 50 mg/day ( mITT population ) .


Statistical significance was also achieved for the percent reduction over PBO in baseline-adjusted partial-onset seizure frequency/28 days for BRV 50 mg/day ( 22.0 % ; p = 0.004 ) but not for the other BRV dose groups .


In the BRV 50 mg/day group , statistical significance was also seen for the 50 % responder rate ( BRV 32.7 % vs. PBO 16.7 % ; p = 0.008 ) and median percent reduction from baseline in partial-onset seizure frequency/week ( BRV 30.5 % vs. PBO 17.8 % ; p = 0.003 ) .


In the exploratory subanalysis by seizure subtype , median percent reduction from baseline in seizure frequency/week and 50 % responder rate were numerically greater than PBO in the BRV 20 and 50 mg/day groups for simple partial , complex partial , and secondarily generalized seizures .


BRV was generally well tolerated , with the majority of TEAEs being mild-to-moderate in intensity .


Of the TEAEs reported by 5 % patients , those with a frequency > 3 % higher than PBO for any dose of BRV compared with PBO were somnolence , dizziness , fatigue , influenza , insomnia , nasopharyngitis , vomiting , diarrhea , urinary tract infection , and nausea .


Adjunctive BRV at a daily dose of 50 mg was associated with statistically significant reductions in seizure frequency compared with PBO .


All doses of BRV showed good tolerability throughout the study .


Although several interventions have shown reduced HIV incidence in clinical trials , the community-level effect of effective interventions on the epidemic when scaled up is unknown .


We investigated whether a multicomponent , multilevel social and behavioural prevention strategy could reduce HIV incidence , increase HIV testing , reduce HIV risk behaviour , and change social and behavioural norms .


For this phase 3 cluster-randomised controlled trial , 34 communities in four sites in Africa and 14 communities in Thailand were randomly allocated in matched pairs to receive 36 months of community-based voluntary counselling and testing for HIV ( intervention group ) or standard counselling and testing alone ( control group ) between January , 2001 , and December , 2011 .


The intervention was designed to make testing more accessible in communities , engage communities through outreach , and provide support services after testing .


Randomisation was done by a computer-generated code and was not masked .


Data were collected at baseline ( n = 14 567 ) and after intervention ( n = 56.683 ) by cross-sectional random surveys of community residents aged 18-32 years .


The primary outcome was HIV incidence and was estimated with a cross-sectional multi-assay algorithm and antiretroviral drug screening assay .


Thailand was excluded from incidence analyses because of low HIV prevalence .


This trial is registered at ClinicalTrials.gov , number NCT00203749 .


The estimated incidence of HIV in the intervention group was 1.52 % versus 1.81 % in the control group with an estimated reduction in HIV incidence of 13.9 % ( relative risk [ RR ] 0.86 , 95 % CI 0.73-1 .02 ; p = 0.082 ) .


HIV incidence was significantly reduced in women older than 24 years ( RR = 0.70 , 0.54-0 .90 ; p = 0.0085 ) , but not in other age or sex subgroups .


Community-based voluntary counselling and testing increased testing rates by 25 % overall ( 12-39 ; p = 0.0003 ) , by 45 % ( 25-69 ; p < 00001 ) in men and 15 % ( 3-28 ; p = 0.013 ) in women .


No overall effect on sexual risk behaviour was recorded .


Social norms regarding HIV testing were improved by 6 % ( 95 % CI 3-9 ) in communities in the intervention group .


These results are sufficiently robust , especially when taking into consideration the combined results of modest reductions in HIV incidence combined with increases in HIV testing and reductions in HIV risk behaviour , to recommend the Project Accept approach as an integral part of all interventions ( including treatment as prevention ) to reduce HIV transmission at the community level .


US National Institute of Mental Health , the Division of AIDS of the US National Institute of Allergy and Infectious Diseases , and the Office of AIDS Research of the US National Institutes of Health .


Measles is a highly infectious respiratory disease which causes 122,000 deaths annually .


Although measles vaccine is extremely safe and effective , vaccine coverage could be improved by a vaccine that is more easily administered and transported .


We developed an inhalable dry powder measles vaccine ( MVDP ) and two delivery devices , and demonstrated safety , immunogenicity , and efficacy of the vaccine in preclinical studies .


Here we report the first clinical trial of MVDP delivered by inhalation .


Sixty adult males aged 18 to 45 years , seropositive for measles antibody , were enrolled in this controlled Phase I clinical study .


Subjects were randomly assigned in 1:1:1 ratio to receive either MVDP by Puffhaler ( ) or by Solovent devices or the licensed subcutaneous measles vaccine .


Adverse events ( AEs ) were recorded with diary cards until day 28 post-vaccination and subjects were followed for 180 days post-vaccination to assess potential serious long term adverse events .


Measles antibody was measured 7 days before vaccination and at days 21 and 77 after vaccination by ELISA and a plaque reduction neutralization test .


All subjects completed the study according to protocol .


Most subjects had high levels of baseline measles antibody .


No adverse events were reported .


MVDP produced serologic responses similar to subcutaneous vaccination .


MVDP was well tolerated in all subjects .


Most subjects had high baseline measles antibody titer which limited ability to measure the serologic responses , and may have limited the adverse events following vaccination .


Additional studies in subjects without pre-existing measles antibody are needed to further elucidate the safety and immunogenicity of MVDP .


To compare the efficacy and tolerability of morning-only polyethylene glycol ( PEG ) with split-dose preparation in hospitalized patients scheduled for colonoscopy .


Morning-only colonoscopy preparation may improve efficiency by allowing patient preparation and colonoscopy to be performed on the same day .


There are limited data comparing morning-only with split-dose preparation , and more studies are needed before morning-only preparation can be routinely recommended .


A single-center , prospective , endoscopist-blinded study was conducted , in which hospitalized patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive 4 L of PEG either on the morning of colonoscopy or as a split-dose ( evening-morning ) .


The primary endpoint was efficacy of bowel preparation measured by the Ottawa scale .


Secondary endpoints were patient compliance and tolerance .


A total of 120 hospitalized patients scheduled for diagnostic colonoscopy were randomized .


The mean total Ottawa score was slightly superior for the morning-only arm , and the upper bound of 95 % confidence interval ( CI ) for difference between arms was less than our prespecified noninferiority margin of 1.5 ( difference = -0.23 ; 95 % CI , -1.72 to 1.25 ) .


The percentage of patients with good bowel preparation was similar for all colonic segments .


There was a trend toward more side effects among patients in the morning-only compared with the split-dose arm ( 71 % vs. 54 % ; P = 0.08 ) .


Compared with morning-only preparation , more patients in the split-dose arm were willing to undergo similar preparation for future colonoscopies ( 71 % vs. 89 % ; P = 0.02 ) .


Morning-only PEG is not inferior to split-dose preparation regarding bowel cleansing efficacy for colonoscopy in hospitalized patients .


However , split-dose preparation was preferred by patients because of less side effects .


Caring for a young person experiencing first-episode psychosis is challenging and can affect carers ' well-being adversely .


While some face-to-face approaches have achieved promising outcomes , they are costly and resource-intensive to provide , restricting their reach and penetration .


Guided self-help in book-form ( or bibliotherapy ) is an alternative but untested approach in these circumstances .


In this study , we aimed to evaluate carers ' beliefs about the usefulness of problem-solving guided self-help manual for primary carers of young people with first-episode psychosis .


A qualitative process evaluation nested in a randomised controlled trial , conducted across two early intervention psychosis services in Melbourne , Australia .


124 carers were randomised to problem-solving guided self-help intervention or treatment as usual .


We also undertook a qualitative process evaluation , using individual interviews , with a random sample of 24 of the intervention group .


A thematic analysis of the qualitative data was undertaken , which is the subject of this paper .


Interviews were conducted between January 2009 and September 2010 .


Three themes were abstracted from the data , reflecting carers ' beliefs about the usefulness of the manual : promoting carers ' well-being , increasing carers ' understanding of and support for the young person with first-episode psychosis , and accessibility and delivery modes of the programme .


This process evaluation highlights that guided self-help is useful in informing and supporting carers of affected young people .


While there is scope for broadening the delivery modes , the approach is easy to use and accessible , and can be used as a cost-effective adjunct to standard support provided to carers , by community mental health nurses and other clinicians .


ACTRN12609000064202 .


Helicobacter pylori ( H. pylori ) remains an important cause of gastric cancer and peptic ulcer disease worldwide .


Treatment of H. pylori infection is one of the effective ways to prevent gastric cancer .


However , standard triple therapy for H. pylori eradication is no longer effective in many countries , including Thailand .


This study was designed to evaluate the efficacy of adding bismuth and probiotic to standard triple therapy for H. pylori eradication .


In this prospective single center study , H. pylori infected gastritis patients were randomized to receive 7 - or 14-day standard triple therapy plus bismuth with probiotic or placebo .


Treatment regimen consisted of 30 mg lansoprazole twice daily , 1 g amoxicillin twice daily , 1 g clarithromycin MR once daily and 1,048 mg bismuth subsalicylate twice daily .


Probiotic bacteria composed of Bifidobacterium lactis , Lactobacillus acidophilus and Lactobacillus paracasei .


Placebo was conventional drinking yogurt without probiotic .


CYP2C19 genotyping and antibiotic susceptibility tests were also done .


H pylori eradication was defined as a negative 13C-urea breath test at least 2 weeks after completion of treatment .


One hundred subjects were enrolled ( 25 each to 7 - and 14-day regimens with probiotic or placebo ) .


Antibiotic susceptibility tests showed 36.7 % metronidazole and 1.1 % clarithromycin resistance .


CYP2C19 genotyping revealed 40.8 % , 49 % and 10.2 % were rapid , intermediate and poor metabolizers , respectively .


The eradication rates of 7 - or 14 regimens with probiotics were 100 % .


Regarding adverse events , the incidence of bitter taste was significantly lower in the 7 - day regimen with the probiotic group compared with 7 - day regimen with placebo ( 40 % vs. 64 % ; p = 0.04 ) .


The 7-day standard triple therapy plus bismuth and probiotic can provide an excellent cure rate of H. pylori ( 100 % ) in areas with low clarithromycin resistance such as Thailand , regardless of CYP2C19 genotype .


Adding a probiotic also reduced treatment-related adverse events .


In an ongoing prospective multicenter randomised placebo-controlled trial we study the adjuvant use of intravitreal dexamethasone in the treatment of patients with suspected bacterial endophthalmitis after phacoemulsification .


In accordance with the study protocol , a mid-inclusion interim analysis of the safety of the study drug was performed .


Patients with suspected endophthalmitis after phacoemulsification were asked to participate in this study .


A diagnostic vitreous biopsy was taken and the patients received intravitreal injections of 400 micrograms dexamethasone or a placebo , plus 0.2 mg vancomycin and 0.05 mg gentamicin .


Injections were repeated after 3 or 4 days .


The safety analysis included : the number of eyes with an evisceration ; no light perception ; or a visual acuity of less than 5/200 .


Treatment outcome was evaluated in terms of : the percentage of patients with a visual acuity of 20/40 or more and 20/100 or more .


The interim analysis included 81 patients with at least 1 year follow-up .


Sixty-three patients ( 65 % ) were culture-positive .


Safety analysis : 7 eyes were eviscerated ( 3 dexamethasone , 4 placebo ) ; 4 eyes had no light perception ( 2 dexamethasone , 2 placebo ) ; and 4 eyes had less than 5/200 vision ( 3 dexamethasone , 1 placebo ) .


Treatment outcome : 70 % of patients had a visual acuity of at least 20/40 .


The safety analysis does not warrant premature discontinuation of the study .


So far , the overall outcome of our treatment regimen , consisting of merely a diagnostic biopsy instead of a vitrectomy and an optimized antibiotic dosing , compares favourably to published literature .


Many well-researched treatments for depression exist .


However , there is not yet enough evidence on whether these therapies , designed for the treatment of depression , are also effective for reducing suicidal ideation .


This research provides valuable information for researchers , clinicians , and suicide prevention policy makers .


Analysis was conducted on the Treatment for Depression Research Collaborative ( TDCRP ) sample , which included CBT , IPT , medication , and placebo treatment groups .


Participants were included in the analysis if they reported suicidal ideation on the HRSD or BDI ( score of 1 ) .


Multivariate linear regression indicated that both IPT ( b = .41 , p < .05 ) and medication ( b = .47 , p < .05 ) yielded a significant reduction in suicide symptoms compared to placebo on the HRSD .


Multivariate linear regression indicated that after adjustment for change in depression these treatment effects were no longer significant .


Moderate Cohens d effect sizes from baseline to post-test differences in suicide score by treatment group are reported .


These analyses were completed on a single suicide item from each of the measures .


Moreover , the TDCRP excluded participants with moderate to severe suicidal ideation .


This study demonstrates the specific effectiveness of IPT and medications in reducing suicidal ideation ( relative to placebo ) , albeit largely as a consequence of their more general effects on depression .


This adds to the growing body of evidence that depression treatments , specifically IPT and medication , can also reduce suicidal ideation and serves to further our understanding of the complex relationship between depression and suicide .


We aimed to study the relationship between measures of adiposity , insulin sensitivity and N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) in the Diabetes Prevention Program ( DPP ) .


The DPP is a completed clinical trial .


Using stored samples from this resource , we measured BMI , waist circumference ( WC ) , an insulin sensitivity index ( ISI ; [ 1/HOMA-IR ] ) and NT-proBNP at baseline and at 2 years of follow-up in participants randomised to placebo ( n = 692 ) , intensive lifestyle intervention ( n = 832 ) or metformin ( n = 887 ) .


At baseline , log NT-proBNP did not differ between treatment arms and was correlated with baseline log ISI ( p < 0.0001 ) and WC ( p = 0.0003 ) but not with BMI ( p = 0.39 ) .


After 2 years of treatment , BMI decreased in the lifestyle and metformin groups ( both p < 0.0001 ) ; WC decreased in all three groups ( p < 0.05 for all ) ; and log ISI increased in the lifestyle and metformin groups ( both p < 0.001 ) .


The change in log NT-proBNP did not differ in the lifestyle or metformin group vs the placebo group ( p > 0.05 for both ) .


In regression models , the change in log NT-proBNP was positively associated with the change in log ISI ( p < 0.005 ) in all three study groups after adjusting for changes in BMI and WC , but was not associated with the change in BMI or WC after adjusting for changes in log ISI .


Circulating NT-proBNP was associated with a measure of insulin sensitivity before and during preventive interventions for type 2 diabetes in the DPP .


This relationship persisted after adjustment for measures of adiposity and was consistent regardless of whether a participant was treated with placebo , intensive lifestyle intervention or metformin .


The aim of this study is to examine the feasibility , efficacy , and safety of a group-based yoga therapy intervention for middle-aged and older women with urinary incontinence .


We conducted a pilot randomized trial of ambulatory women aged 40 years and older with stress , urgency , or mixed-type incontinence .


Women were randomized to a 6-week yoga therapy program ( n = 10 ) consisting of twice weekly group classes and once weekly home practice or a wait-list control group ( n = 9 ) .


All participants also received written pamphlets about standard behavioral self-management strategies for incontinence .


Changes in incontinence were assessed with 7-day voiding diaries .


The mean ( SD ) age was 61.4 ( 8.2 ) years , and the mean baseline frequency of incontinence was 2.5 ( 1.3 ) episodes/d .


After 6 weeks , the total incontinence frequency decreased by 70 % ( 1.8 [ 0.9 ] fewer episodes/d ) in the yoga therapy versus 13 % ( 0.3 [ 1.7 ] fewer episodes/d ) in the control group ( P = 0.049 ) .


Participants in the yoga therapy group also reported an average of 71 % decrease in stress incontinence frequency ( 0.7 [ 0.8 ] fewer episodes/d ) compared with a 25 % increase in controls ( 0.2 [ 1.1 ] more episodes/d ) ( P = 0.039 ) .


No significant differences in reduction in urgency incontinence were detected between the yoga therapy versus control groups ( 1.0 [ 1.0 ] versus 0.5 [ 0.5 ] fewer episodes/d ; P = 0.20 ) .


All women starting the yoga therapy program completed at least 90 % of the group classes and practice sessions .


Two participants in each group reported adverse events unrelated to the intervention .


Findings provide preliminary evidence to support the feasibility , efficacy , and safety of a group-based yoga therapy intervention to improve urinary incontinence in women .


The role of genetics for predicting the response to cognitive behavior therapy ( CBT ) for social anxiety disorder ( SAD ) has only been studied in one previous investigation .


The serotonin transporter ( 5-HTTLPR ) , the catechol-o-methyltransferase ( COMT ) val158met , and the tryptophan hydroxylase-2 ( TPH2 ) G-703T polymorphisms are implicated in the regulation of amygdala reactivity and fear extinction and therefore might be of relevance for CBT outcome .


The aim of the present study was to investigate if these three gene variants predicted response to CBT in a large sample of SAD patients .


Participants were recruited from two separate randomized controlled CBT trials ( trial 1 : n = 112 , trial 2 : n = 202 ) .


Genotyping were performed on DNA extracted from blood or saliva samples .


Effects were analyzed at follow-up ( 6 or 12 months after treatment ) for both groups and for each group separately at post-treatment .


The main outcome measure was the Liebowitz Social Anxiety Scale Self-Report .


At long-term follow-up , there was no effect of any genotype , or gene gene interactions , on treatment response .


In the subsamples , there was time by genotype interaction effects indicating an influence of the TPH2 G-703T-polymorphism on CBT short-term response , however the direction of the effect was not consistent across trials .


None of the three gene variants , 5-HTTLPR , COMTval158met and TPH2 G-703T , was associated with long-term response to CBT for SAD .


ClinicalTrials.gov ( ID-NCT0056496 ) .


Balance control relies on accurate perception of visual , somatosensory and vestibular cues .


Sensory flow is impaired in Multiple Sclerosis ( MS ) and little is known about the ability of the sensory systems to adapt after neurological lesions reducing sensory impairment .


The aims of the present study were to verify whether : 1 .


Balance rehabilitation administered in a challenging sensory conditions would improve stability in upright posture .


2 .


The improvement in a treated sensory condition would transfer to a non treated sensory condition .


Fifty three persons with MS , median ( min-max ) EDSS score of 5 ( 2.5-6 .5 ) , participated in a RCT and were randomly assigned to two groups .


The Experimental group received balance rehabilitation aimed at improving motor and sensory strategies .


The Control group received rehabilitation treatment which did not include training of sensory strategies .


Persons with MS were blindly assessed by means of a stabilometric platform with eyes open , eyes closed and dome , on both firm surface and foam .


Anterior-posterior and medio-lateral sway , velocity of sway and the length of Center of Pressure ( CoP ) trajectory were calculated in the six sensory conditions .


Experimental group showed statistically significant improvement ( P < 0.05 ) in stability in upright posture in eyes closed condition on firm surface , and in eyes open , closed , and dome conditions on foam .


No differences were observed between groups in the eyes open condition on firm surface nor in the sensory condition not addressed during the treatment .


After rehabilitation people with MS can recover from sensory impairments thus improving upright balance .


Further , the improvement seems to be context-dependent and present just in the treated sensory conditions .


ClinicalTrials NCT02131285 .


To assess the effectiveness of a tailored theory-based , Web-delivered intervention ( Young Adults Eating and Active for Health ) developed using community-based participatory research process .


A 15-month ( 10-week intensive intervention with a 12-month follow-up ) randomized , controlled trial delivered via Internet and e-mail .


Thirteen college campuses .


A total of 1,639 college students .


Twenty-one mini-educational lessons and e-mail messages ( called nudges ) developed with the non-diet approach and focusing on eating behavior , physical activity , stress management , and healthy weight management .


Nudges were short , frequent , entertaining , and stage-tailored to each behavior , and reinforced lesson content .


All participants were assessed at baseline , postintervention ( 3 months from baseline ) , and follow-up ( 15 months from baseline ) for primary outcomes of weight , body mass index ( BMI ) , fruit and vegetable intake ( FVI ) , physical activity ( PA ) , and perceived stress ; and secondary outcomes of waist circumference , percent dietary fat , energy from sugar-sweetened beverages , servings of whole grains , self-instruction and regulation for mealtime behavior , hours of sleep , and stage of readiness for change for consuming 5 cups of FVI , completing 150 minutes of PA/wk , and managing stress on most days of the week .


Demographics were collected at baseline .


Chi-square analysis and mixed-models repeated measures analysis were performed to determine differences between experimental and control outcomes .


There were no differences between experimental and control participants in BMI , weight , and waist circumference .


There were small improvements in FVI ( P = .001 ) , vigorous PA in females ( P = .05 ) , fat intake ( P = .002 ) , self-instruction ( P = .001 ) , and regulation ( P = .004 ) for mealtime behavior , and hours of sleep ( P = .05 ) at postintervention , but improvements were not maintained at follow-up .


At postintervention , a greater proportion of experimental participants were in the action/maintenance stages for FVI ( P = .019 ) and PA ( P = .002 ) than control .


Young Adults Eating and Active for Health is one of the first studies to use the community-based participatory research process of PRECEDE-PROCEED to develop a non-diet approach intervention .


Although there were no differences between experimental and control participants in weight change or BMI , the intervention supported positive change in behaviors that may mediate excessive weight gain , such as increasing FVI and more healthful self-regulation mealtime behaviors immediately postintervention .


Additional strategies to maintain the behavior changes need to be explored .


Endothelial dysfunction has been suggested as a potential mechanism by which ambient air pollution may cause acute cardiovascular events .


Recently , plasma nitrite has been developed as a marker of endothelial dysfunction .


We examined the changes in plasma nitrite concentration associated with increases in ambient air pollutant concentrations in the previous 7 d.


We linked up to three measurements of plasma nitrite concentrations obtained from 49 students to 24-h average concentrations of five criteria air pollutants [ particle mass < 2.5 m in aerodynamic diameter ( PM ( 2.5 ) ) , carbon monoxide ( CO ) , sulfur dioxide ( SO ) , nitrogen dioxide ( NO ) , and ozone ( O ) ] measured at two monitoring sites closest to Rutgers University campus ( 6-15 miles ) in New Jersey during the years 2006-2009 .


We examined the change in plasma nitrite associated with each interquartile-range ( IQR ) increase in pollutant concentration in the previous 24h and six preceding 24-h periods , using linear mixed models .


IQR increases in mean PM ( 2.5 ) ( 7.0 g/m ) and CO ( 161.7 parts per billion ) concentrations in the first 24h before the plasma nitrite measurement were associated with increased plasma nitrite concentrations ( PM ( 2.5 ) : 15.5 nanomolar ; 95 % confidence interval ( CI ) : 2.4 , 28.5 ; CO : 15.6 nanomolar ; 95 % CI : 2.4 , 28.9 ) .


Increased plasma nitrite associated with IQR increases in O and SO concentrations over longer lags were observed .


Rapid increases in plasma nitrite following exposure to ambient air pollutants support the hypothesis that ambient air pollution is associated with inducible nitric oxide synthase-mediated systemic inflammation in humans .


To compare the effectiveness and acceptability of outpatient polypectomy with inpatient polypectomy .


Pragmatic multicentre randomised controlled non-inferiority study .


Outpatient hysteroscopy clinics in 31 UK National Health Service hospitals .


507 women who attended as outpatients for diagnostic hysteroscopy because of abnormal uterine bleeding and were found to have uterine polyps .


Participants were randomly assigned to either outpatient uterine polypectomy under local anaesthetic or inpatient uterine polypectomy under general anaesthesia .


Data were collected on women 's self reported bleeding symptoms at baseline and at 6 , 12 , and 24 months .


Data were also collected on pain and acceptability of the procedure at the time of polypectomy .


The primary outcome was successful treatment , determined by the women 's assessment of bleeding at six months , with a prespecified non-inferiority margin of 25 % .


Secondary outcomes included generic ( EQ-5D ) and disease specific ( menorrhagia multi-attribute scale ) quality of life , and feasibility and acceptability of the procedure .


73 % ( 166/228 ) of women in the outpatient group and 80 % ( 168/211 ) in the inpatient group reported successful treatment at six months ( intention to treat relative risk 0.91 , 95 % confidence interval 0.82 to 1.02 ; per protocol relative risk 0.92 , 0.82 to 1.02 ) .


Failure to remove polyps was higher ( 19 % v 7 % ; relative risk 2.5 , 1.5 to 4.1 ) and acceptability of the procedure was lower ( 83 % v 92 % ; 0.90 , 0.84 to 0.97 ) in the outpatient group Quality of life did not differ significantly between the groups .


Four uterine perforations , one of which necessitated bowel resection , all occurred in the inpatient group .


Outpatient polypectomy was non-inferior to inpatient polypectomy .


Failure to remove a uterine polyp was , however , more likely with outpatient polypectomy and acceptability of the procedure was slightly lower .


International Clinical Trials Registry 65868569 .


Observational studies have raised concerns that high-potency statins increase the risk of acute kidney injury .


We therefore examined the incidence of kidney injury across 2 randomized trials of statin therapy .


PROVE IT-TIMI 22 enrolled 4162 subjects after an acute coronary syndrome ( ACS ) and randomized them to atorvastatin 80 mg/day versus pravastatin 40 mg/day .


A-to-Z enrolled 4497 subjects after ACS and randomized them to a high-potency ( simvastatin 40 mg/day 1 months , then simvastatin 80 mg/day ) versus a delayed moderate-potency statin strategy ( placebo 4 months , then simvastatin 20 mg/day ) .


Serum creatinine was assessed centrally at serial time points .


Adverse events ( AEs ) relating to kidney injury were identified through database review .


Across both trials , mean serum creatinine was similar between treatment arms at baseline and throughout follow-up .


In A-to-Z , the incidence of a 1.5-fold or 0.3 mg/dL rise in serum creatinine was 11.4 % for subjects randomized to a high-potency statin regimen versus 12.4 % for those on a delayed moderate-potency regimen ( odds ratio [ OR ] , 0.91 ; 95 % confidence interval [ CI ] , 0.76 to 1.10 ; P = 0.33 ) .


In PROVE IT-TIMI 22 , the incidence was 9.4 % for subjects randomized to atorvastatin 80 mg/day and 10.6 % for subjects randomized to pravastatin 40 mg/day ( OR , 0.88 ; 95 % CI , 0.71 to 1.09 ; P = 0.25 ) .


Consistent results were observed for different kidney injury thresholds and in individuals with diabetes mellitus or with moderate renal dysfunction .


The incidence of kidney injury-related adverse events ( AEs ) was not statistically different for patients on a high-potency versus moderate-potency statin regimen ( OR , 1.06 ; 95 % CI , 0.68 to 1.67 ; P = 0.78 ) .


For patients enrolled in 2 large randomized trials of statin therapy after ACS , the use of a high-potency statin regimen did not increase the risk of kidney injury .


Myeloid-derived suppressor cells ( MDSC ) and regulatory T cells ( Treg ) play a key role in the progression of head and neck squamous cell carcinoma ( HNSCC ) .


On the basis of our preclinical data demonstrating that phosphodiesterase-5 ( PDE5 ) inhibition can modulate these cell populations , we evaluated whether the PDE5 inhibitor tadalafil can revert tumor-induced immunosuppression and promote tumor immunity in patients with HNSCC .


First , we functionally and phenotypically characterized MDSCs in HNSCCs and determined , retrospectively , whether their presence at the tumor site correlates with recurrence .


Then , we performed a prospective single-center , double-blinded , randomized , three-arm study in which patients with HNSCC undergoing definitive surgical resection of oral and oropharyngeal tumors were treated with tadalafil 10 mg/day , 20 mg/day , or placebo for at least 20 days preoperatively .


Blood and tumor MDSC and Treg presence and CD8 ( + ) T-cell reactivity to tumor antigens were evaluated before and after treatment .


MDSCs were characterized in HNSCC and their intratumoral presence significantly correlates with recurrence .


Tadalafil treatment was well tolerated and significantly reduced both MDSCs and Treg concentrations in the blood and in the tumor ( P < 0.05 ) .


In addition , the concentration of blood CD8 ( + ) T cells reactive to autologous tumor antigens significantly increased after treatment ( P < 0.05 ) .


Tadalafil immunomodulatory activity was maximized at an intermediate dose but not at higher doses .


Mechanistic analysis suggests a possible off-target effect on PDE11 at high dosages that , by increasing intracellular cAMP , may negatively affect antitumor immunity .


Tadalafil seems to beneficially modulate the tumor micro - and macro-environment in patients with HNSCC by lowering MDSCs and Tregs and increasing tumor-specific CD8 ( + ) T cells in a dose-dependent fashion .


Tafazzin ( TAZ ) , a transmembrane protein contributes in mitochondrial structural and functional modifications through cardiolipin remodeling .


TAZ mutations are associated with several diseases , but studies on the role of TAZ protein in carcinogenesis and radiotherapy ( RT ) response is lacking .


Therefore we investigated the TAZ expression in rectal cancer , and its correlation with RT , clinicopathological and biological variables in the patients participating in a clinical trial of preoperative RT. .


140 rectal cancer patients were included in this study , of which 65 received RT before surgery and the rest underwent surgery alone .


TAZ expression was determined by immunohistochemistry in primary cancer , distant , adjacent normal mucosa and lymph node metastasis .


In-silico protein-protein interaction analysis was performed to study the predictive functional interaction of TAZ with other oncoproteins .


TAZ showed stronger expression in primary cancer and lymph node metastasis compared to distant or adjacent normal mucosa in both non-RT and RT patients .


Strong TAZ expression was significantly higher in stages I-III and non-mucinious cancer of non-RT patients .


In RT patients , strong TAZ expression in biopsy was related to distant recurrence , independent of gender , age , stages and grade ( p = 0.043 , HR , 6.160 , 95 % CI , 1.063-35 .704 ) .


In silico protein-protein interaction study demonstrated that TAZ was positively related to oncoproteins , Livin , MAC30 and FXYD-3 .


Strong expression of TAZ protein seems to be related to rectal cancer development and RT response , it can be a predictive biomarker of distant recurrence in patients with preoperative RT. .


The potential benefit of dual antiplatelet therapy beyond 1 year after a myocardial infarction has not been established .


We investigated the efficacy and safety of ticagrelor , a P2Y12 receptor antagonist with established efficacy after an acute coronary syndrome , in this context .


We randomly assigned , in a double-blind 1:1:1 fashion , 21,162 patients who had had a myocardial infarction 1 to 3 years earlier to ticagrelor at a dose of 90 mg twice daily , ticagrelor at a dose of 60 mg twice daily , or placebo .


All the patients were to receive low-dose aspirin and were followed for a median of 33 months .


The primary efficacy end point was the composite of cardiovascular death , myocardial infarction , or stroke .


The primary safety end point was Thrombolysis in Myocardial Infarction ( TIMI ) major bleeding .


The two ticagrelor doses each reduced , as compared with placebo , the rate of the primary efficacy end point , with Kaplan-Meier rates at 3 years of 7.85 % in the group that received 90 mg of ticagrelor twice daily , 7.77 % in the group that received 60 mg of ticagrelor twice daily , and 9.04 % in the placebo group ( hazard ratio for 90 mg of ticagrelor vs. placebo , 0.85 ; 95 % confidence interval [ CI ] , 0.75 to 0.96 ; P = 0.008 ; hazard ratio for 60 mg of ticagrelor vs. placebo , 0.84 ; 95 % CI , 0.74 to 0.95 ; P = 0.004 ) .


Rates of TIMI major bleeding were higher with ticagrelor ( 2.60 % with 90 mg and 2.30 % with 60 mg ) than with placebo ( 1.06 % ) ( P < 0.001 for each dose vs. placebo ) ; the rates of intracranial hemorrhage or fatal bleeding in the three groups were 0.63 % , 0.71 % , and 0.60 % , respectively .


In patients with a myocardial infarction more than 1 year previously , treatment with ticagrelor significantly reduced the risk of cardiovascular death , myocardial infarction , or stroke and increased the risk of major bleeding .


( Funded by AstraZeneca ; PEGASUS-TIMI 54 ClinicalTrials.gov number , NCT01225562 . )


To impact on the obesity epidemic , interventions that prevent weight gain across populations are urgently needed .


However , even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings .


Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle .


Despite the recognised need , few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities .


Here we describe the rationale , design and implementation of a Healthy Lifestyle Program for women living in small rural communities ( HeLP-her Rural ) .


The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity , self-management intervention .


Six hundred women from 42 small rural communities in Australia will be randomised as clusters ( n-21 control towns and n = 21 intervention towns ) .


A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program .


Implementing population interventions to prevent obesity is complex , costly and challenging .


To address these barriers , evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation .


Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level .


Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level .


The learnings from this trial will impact on the design and implementation of population obesity prevention strategies nationally and internationally .


ANZ clinical trial registry ACTRN12612000115831 .


Date of registration 24/01/2012 .


To assess the efficacy of high-frequency ( 20 Hz ) brain stimulation on lower limb motor function in subjects with chronic ( > 6 mo ) subcortical stroke .


Double-blind , placebo-controlled crossover study .


University hospital .


Right-handed subjects ( N = 10 ) affected by a first-ever subcortical stroke in the territory of the middle cerebral artery were included in this study .


Repetitive transcranial magnetic stimulation ( rTMS ) was delivered with the H-coil , specifically designed to target deeper and larger brains regions .


Each subject received both real and sham rTMS in a random sequence .


The 2 rTMS cycles ( real or sham ) were composed of 11 sessions each , administered over 3 weeks and separated by a 4-week washout period .


Lower limb functions were assessed by the lower limb Fugl-Meyer scale , the 10-m walk test , and the 6-minute walk test before and 1 day after the end of each treatment period , as well as at a 4-week follow-up .


Real rTMS treatment was associated with a significant improvement in lower limb motor function .


This effect persisted over time ( follow-up ) and was significantly greater than that observed with sham stimulation .


A significant increase in walking speed was also found after real rTMS , but this effect did not reach statistical significance in comparison with the sham stimulation .


These data demonstrated that 3 weeks of high-frequency deep rTMS could induce long-term improvements in lower limb functions in the chronic poststroke period , lasting at least 1 month after the end of the treatment .


Preclinical data suggest combining a mammalian target of rapamycin inhibitor with erlotinib could provide synergistic antitumor effects in advanced non-small-cell lung cancer ( NSCLC ) .


In this multicenter , open-label , phase II study , patients with advanced NSCLC that progressed after one to two previous chemotherapy regimens were randomized 1:1 to erlotinib 150 mg/dayeverolimus 5 mg/day .


Primary end point was the disease control rate ( DCR ) at 3 months ; secondary end points included progression-free survival ( PFS ) and safety .


One hundred thirty-three patients received everolimus-erlotinib ( n = 66 ) or erlotinib alone ( n = 67 ) .


The DCR at 3 months was 39.4 % and 28.4 % , respectively .


The probability for the difference in disease control at 3 months to be 15 % was estimated to be 29.8 % , which was below the prespecified probability threshold of 40 % .


Median PFS was 2.9 and 2.0 months , respectively .


Grade 3/4 adverse events occurred in 72.7 % and 32.3 % of patients , respectively .


Grade 3/4 stomatitis was observed in 31.8 % of combination therapy recipients .


Everolimus 5 mg/day plus erlotinib 150 mg/day was not considered sufficiently efficacious per the predefined study criteria .


The combination does not warrant further investigation based on increased toxicity and the lack of substantial improvement in disease stabilization .


Some pregnancy complications are characterized by increased levels of cell-free fetal ( cffDNA ) and maternal DNA ( cfmDNA ) , the latter may also be elevated during physical strain .


This study aims at assessing the impact of exercise and metformin intervention in pregnancy , and to compare the levels of cell free DNA in pregnant women with or without PCOS diagnosis .


Consecutive women from two previous randomized controlled trials in pregnancy were included .


Women came from a trial with organized exercise vs. standard antenatal care in pregnancy and a trial of metformin vs. placebo in PCOS women .


Levels of cffDNA , cfmDNA and cell-free total DNA ( cftDNA ) were measured by qPCR .


Training in pregnancy did not affect the levels of cffDNA , cfmDNA or cftDNA .


PCOS-women treated with metformin had lower levels of cfmDNA and cftDNA at week 32 ( mean SD : 301 162 versus 570 337 , p = 0.012 , 345 173 versus 635 370 , p = 0.019 ) ; otherwise the levels were comparable to PCOS-controls .


Metformin-treated PCOS-women had higher cffDNA at inclusion , in the 1st trimester ; later on in pregnancy the levels in the metformin and placebo groups were equal .


A comparison of pregnant women in the exercise study ( TRIP ) to placebo-treated pregnant PCOS-women , showed the levels of cffDNA , cfmDNA or cftDNA during mid-pregnancy ( weeks 18-36 ) to be equal .


Training during pregnancy was not associated with altered levels of cffDNA cfmDNA or cftDNA , but metformin treatment may reduce cfmDNA and cftDNA in pregnant PCOS women .


Data concerning the effects of afternoon snacking on ingestive behavior , mood , and cognition are limited .


The purpose of this study was to compare 1088 kJ of high-protein ( HP ) or high-fat ( HF ) afternoon snacks vs. no snacking on appetite , food intake , mood , and cognition in adolescents .


Thirty-one healthy adolescents ( age : 17 1 y ) consumed the following afternoon snacks ( in randomized order ) for 3 d : HP snack ( 26 g of protein/6 g of fat per 27 g of carbohydrates ) , HF snack ( 4 g of protein/12 g of fat per 32 g of carbohydrates ) , and no snack ( NoS ) .


On day 4 of each treatment , the participants completed an 8-h testing day containing pre - and postsnack appetite questionnaires , food cue-stimulated functional MRI brain scans , mood , cognitive function , and eating initiation .


Ad libitum dinner and evening snacks were provided and assessed .


HP , but not HF , delayed eating initiation vs. NoS ( P < 0.05 ) .


Both snacks reduced appetite vs. NoS ( P < 0.001 ) with HP eliciting greater reductions than HF ( P < 0.05 ) .


Only HF led to reductions in corticolimbic activation in brain regions controlling food motivation/reward vs. NoS ( P < 0.01 ) .


Although no treatment differences in daily energy intake were detected , HP led to greater protein consumption than NoS ( P < 0.05 ) and greater protein and lower fat consumption than HF ( both , P < 0.05 ) .


HP led to fewer HF/high-sugar evening snacks than NoS ( P < 0.01 ) and HF ( P = 0.09 ) .


Although no treatment effects were detected for mood and cognition , HP tended to reduce confusion-bewilderment ( P = 0.07 ) and increase cognitive flexibility ( P = 0.09 ) , whereas NoS reduced tension-anxiety ( P < 0.05 ) and vigor-activity ( P < 0.05 ) .


Afternoon snacking , particularly on HP soy foods , improves appetite , satiety , and diet quality in adolescents , while beneficially influencing aspects of mood and cognition .


This trial was registered at clinicaltrials.gov as NCT01781286 .


Phlebotropic activity , protective effect on the capillaries and anti-inflammatory properties of the Flavonoids have been reported in literature .


Recently , we evaluated the effect of these drugs in controlling postoperative symptoms of proctologic surgery .


In this randomized study we compared the results obtained in two groups of patients , with grade II haemorrhoids , submitted to radiofrequency coagulation of the hemorrhoidal nodule with radiofrequency scalpel ( CHR ) , to verify the effects of Flavonoids to reduce further symptoms after treatment .


Out of 70 patients initially randomized , a total of 59 patients regularly returned to outpatient visit at least for 1 month of follow-up .


Consequently , two groups of patients were considered : Group A , represented by 28 individuals treated with Flavonoids , and Group B , consisting of 31 patients as a control group .


Our purpose was to determine : grade of pain after procedure and at first evacuation ( score from 1 to 10 ) , bleeding , incidence of failures and complications , patient 's satisfaction after 30 days from the treatment ( score from 1 to 10 ) .


We observed that the results obtained regarding the pain reported at the end of procedures ( 2.51 1.4 for group A and 2.54 1.15 for group B ) and at the first evacuation ( 2.6 .1.52 for group A and 2.7 1.18 for group B ) are similar in both study groups .


Instead , the mean score on overall satisfaction at 30 days from the treatment showed a statistical significance ( 8.32 1.72 for group A and 6.64 1.78 for group B ; p < 0.05 ) .


There were no reported other important issues .


Our results confirm the usefulness of Flavonoids to make more comfortable the post-treatment period .


To investigate the clinical performance of a silorane-based composite resin used for repairing dimethacrylate - based composite restorations .


One operator repaired defective dimethacrylate-based resin restorations that were randomly assigned to one of two treatment groups : control ( n = 50 ) , repaired with Adper SE Plus and Filtek P60 Posterior Restorative ( 3M ESPE ) ; or test ( n = 50 ) , repaired with P90 System Adhesive Self-Etch Primer and Bond and Filtek P90 Low Shrink Posterior Restorative ( 3M ESPE ) .


After 1 week , restorations were finished and polished .


Two calibrated examiners ( weighted Kappa0 .78 ) evaluated the repaired restorations , blindly and independently , at baseline , after 6 months , 1 and 2 years .


The parameters examined were marginal adaptation , anatomic form , surface roughness , marginal discoloration , postoperative sensitivity , and secondary caries .


The restorations were classified as Alfa , Bravo , or Charlie , according to modified US Public Health Service criteria .


Variation in the levels of clinical parameters over time was evaluated by Friedman 's ANOVA ( = 0.05 ) .


The Mann-Whitney test assessed the differences between the materials for all clinical criteria at baseline , 6-month , 1 - and 2-year recalls ( = 0.05 ) .


The Wilcoxon test compared each composite resin for all clinical criteria at the same recalls ( = 0.05 ) .


After two years , 79 repaired restorations were re-examined .


No statistically significant differences were found between the materials at baseline or at the 2-year recall ( p > 0.05 ) .


Comparing baseline and 2-year recall , there was a statistically significant difference for marginal discoloration ( p = 0.029 ) in silorane-based composite restorations .


After two years , the clinical performance of the silorane-based composite was similar to that of the dimethacrylate-based composite when used to make repairs .


Neuropsychological and neurological deficits are still major causes of mortality and morbidity after cardiac surgery .


These complications are thought to be caused by embolisms and cerebral hypoxia .


Thus , continuous neuromonitoring is essential during cardiac surgery due to cerebral oxygen desaturation during different periods .


Near-infrared spectrophotometry ( NIRS ) , anon-invasive method , appears to offer many advantages for monitoring cerebral oxygenation and hemodynamics .


Desaturation of cerebral oxygen may occur at the beginning of cardiopulmonary bypass ( CPB ) or during the low perfusion and rewarming stages if not corrected .


This study was designed to assess the effects of sevoflurane on cerebral protection during CPB .


Eighty patients were divided into two groups .


Anesthesia was maintained either with fentanyl and midazolam ( total intravenous anesthesia , TIVA ) or with one minimum alveolar concentration of sevoflurane and fentanyl .


Cerebral desaturation was defined as an absolute decrease in saturation of 20 % from baseline cerebral saturation .


When desaturation occurred , PaCO2 , hematocrit and PaO2 levels were checked and corrected .


If desaturation continued , anesthetic depth was increased to reserve saturation with 50-100mg of propofol .


NIRS values and hemodynamics were recorded at predetermined time intervals .


Cerebral oxygen saturation values on the right side were higher in the sevoflurane group than in the TIVA group .


The values on the left side were higher in the sevoflurane group than in the TIVA group , and meaningful differences were seen at the lowest temperature and at 36C .


Oxygen saturation was higher in the sevoflurane group than in the TIVA group .


Thus , the effect of sevoflurane was useful for maintaining cerebral oxygen saturation during CBP .


Moderate alcohol consumption has been associated with a reduced risk of mortality and coronary artery disease .


The relationship between cardiovascular health and alcohol use in type 2 diabetes is less clear .


The current study assesses the effects of alcohol use among participants in the Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified-Release Controlled Evaluation ( ADVANCE ) trial .


The effects of alcohol use were explored using Cox regression models , adjusted for potential confounders .


The study end points were cardiovascular events ( cardiovascular death , myocardial infarction , and stroke ) , microvascular complications ( new or worsening nephropathy or retinopathy ) , and all-cause mortality .


During a median of 5 years of follow-up , 1,031 ( 9 % ) patients died , 1,147 ( 10 % ) experienced a cardiovascular event , and 1,136 ( 10 % ) experienced a microvascular complication .


Compared with patients who reported no alcohol consumption , those who reported moderate consumption had fewer cardiovascular events ( adjusted hazard ratio [ aHR ] 0.83 ; 95 % CI 0.72-0 .95 ; P = 0.008 ) , less microvascular complications ( aHR 0.85 ; 95 % CI 0.73-0 .99 ; P = 0.03 ) , and lower all-cause mortality ( aHR 0.87 ; 96 % CI 0.75-1 .00 ; P = 0.05 ) .


The benefits were particularly evident in participants who drank predominantly wine ( cardiovascular events aHR 0.78 , 95 % CI 0.63-0 .95 , P = 0.01 ; all-cause mortality aHR 0.77 , 95 % CI 0.62-0 .95 , P = 0.02 ) .


Compared with patients who reported no alcohol consumption , those who reported heavy consumption had dose-dependent higher risks of cardiovascular events and all-cause mortality .


In patients with type 2 diabetes , moderate alcohol use , particularly wine consumption , is associated with reduced risks of cardiovascular events and all-cause mortality .


Split-thickness skin graft ( STSG ) donor sites sometimes cause more postoperative morbidity for patients than the wound covered with the graft .


Yet , there is no consensus on which dressings are best suited to treat these donor sites .


To evaluate two commonly used modern wound dressings in the postoperative healing of STSG donor sites in a prospective randomized controlled trial .


38 patients were randomly assigned to treatment of an STSG donor site with an alginate dressing or a polyurethane film dressing .


The primary outcome measures were postoperative pain scores , secondary outcome variables were time to epithelialization , dressing changes and complications .


Postoperative pain on day 1 was significantly lower in the polyurethane film group ( 2.05 vs. 0.79 , p = 0.035 ) as compared to the alginate group .


This difference was not detected on day 5 ( 0.89 vs. 0.53 , p = 0.52 ) .


Time to epithelialization did not differ significantly between the two dressing groups .


There were more dressing changes in the polyurethane film group and problems with leakage .


Whereas film dressings resulted in initially lower pain scores , alginate dressings caused fewer additional dressing changes and less leakage .


Multiple techniques and implants are available for all-inside meniscal repair , but the knowledge about their failure rates and functional outcome is still incomplete .


The hypothesis was that there might be differences between meniscal arrows and suture devices regarding reoperation rates and functional outcome .


Thereby , the aim of this study was to compare clinical results following repair with the Biofix ( ) arrows or the FasT-Fix ( ) suture devices .


In this RCT , 46 patients were treated either by Biofix ( ) ( n = 21 ) or FasT-Fix ( ) ( n = 25 ) .


The main outcome was reoperation within 2 years .


Knee function and activity level were evaluated by KOOS and Tegner activity scale .


Twelve out of 46 ( 26 % ) patients were reoperated within 2 years , nine out of 21 ( 43 % ) in the Biofix ( ) - group versus three out of 25 ( 12 % ) in the FasT-Fix ( ) - group ( p = 0.018 ) .


The relative risk of reoperation was 3.6 times higher for Biofix ( ) compared to FasT-Fix ( ) ( 95 % confidence interval 1.1-11 .5 ) .


Both treatment groups had significant increase in all KOOS subscales , but there were no major differences between the groups .


The subgroup of reoperated patients differed from the other patients with higher Tegner score preoperatively ( median 5 vs. 4 ) ( p = 0.037 ) and at 3-month follow-up ( median 4 vs. 3 ) ( p = 0.010 ) .


These results indicate that FasT-Fix ( ) suture is superior to Biofix ( ) arrows with significant lower failure rate .


Functional outcome did not depend on repair technique .


Higher activity score preoperatively and at 3-month follow-up in the reoperated patients indicates that activity level may influence on the risk of reoperation .


I.


Antidepressant medication ( ADM ) is thought to reduce depressive symptoms by altering emotion-generative brain systems .


However , it is unknown whether successful ADM treatment is associated with changes in psychobehavioral strategies used to regulate emotions .


We examined depressive symptoms and emotion regulation strategies before and after ADM in the international Study to Predict Optimized Treatment in Depression ( iSPOT-D ) .


The study enrolled 1008 adult patients with MDD ( 18-65 years old ) from 18 primary and psychiatric care sites worldwide .


Patients were randomly assigned to an 8-week course of escitalopram , sertraline , or venlafaxine-extended-release .


We examined whether ADM is associated with changes in suppression , usually associated with maladaptive outcomes , and reappraisal , usually associated with adaptive outcomes .


We also tested whether changes in emotion regulation predict changes in depressive symptoms following ADM.


We observed more adaptive emotion regulation ( decreased use of suppression and increased use of reappraisal ) following ADM. Furthermore , the largest improvements in emotion regulation were associated with the best treatment outcomes .


Because we assessed acute outcomes , it is not yet known if the effects of ADM on emotion regulation would persist over time .


ADMs are associated with acute , adaptive changes in the psychobehavioral strategies used to regulate emotions .


Interpretation of double-blind placebo-controlled food challenges ( DBPCFC ) can be difficult , particularly with ambiguous subjective symptoms .


Early opening of the challenge key ( which day is verum and which placebo ) may influence the clinician 's interpretation of the DBPCFC result .


Fifty-one clinicians reviewing results of 19 DBPCFCs with ambiguous clinical symptoms were randomized into a key first strategy ( opening the DBPCFC key before reviewing the symptoms on both challenge days and deciding on the DBPCFC result ) or a symptoms first strategy ( reviewing symptoms and interpreting both test days as positive or negative before opening the key and deciding on the DBPCFC result ) .


The proportion of DBPCFCs considered inconclusive was comparable between the two strategy groups ( p = 0.791 ) .


Participants in the symptoms first group were more likely to consider a DBPCFC as positive ( in 14 tests , 73.7 % ) than subjects in the key first group ( four tests , 21.1 % ) .


The number of positive tests was higher in the symptoms first group ( median 50.0 % , interquartile range [ IQR ] 23.1-76 .9 % ) than in the key first groups ( 44.0 % , IQR 12.0-68 .0 % , p = 0.031 ) .


This was independent of the participant 's profession ( pediatrician or other ) , age , gender , or years of experience ( p > 0.3 ) .


Clinicians differ in their interpretation of DBPCFC results when symptoms are ambiguous .


Opening the key of a DBPCFC before reviewing and interpreting symptoms significantly reduces the likelihood of the challenge being interpreted as positive .


Guidelines for performing DBPCFCs should standardize the moment of opening the challenge key .


The bivalent fear of evaluation ( BFOE ) model suggests that fears of negative evaluation ( FNE ) and positive evaluation ( FPE ) are distinct features in social anxiety disorder as well as in non-clinical variations of social anxiety .


The constructs can be measured utilizing the Brief Fear of Negative Evaluation Scale Revised ( BFNE-R ) and the Fear of Positive Evaluation Scale ( FPES ) , respectively .


Whereas the distinction between FNE and FPE has been well examined in survey studies , concomitant evidence from laboratory tasks is scarce .


The present study tested whether subjective unpleasantness responses to short films simulating positive and negative evaluation from others are related to individual differences in FNE and FPE .


Ninety-eight unselected individuals watched 24 short films displaying actors expressing positive , negative and neutral sentences and rated their responses on unpleasantness .


Furthermore , pride responses to positive films were examined since these can be expected to discriminate between FPE and FNE .


As expected , higher BFNE-R scores were related to more unpleasant responding to negative films , whereas higher FPES scores were related to more unpleasant responding to positive films .


Furthermore , experience of pride following positive films correlated positively with BFNE-R , but negatively with FPES scores .


Participants were university students which limits representativeness .