Fewer water flushes [ mean 0.70.9 times ( range : 0-3 times ) in Group A vs 1.91.5 times ( range : 0-6 times ) in Group B , P < 0.05 ] in the pronase premedication group did not affect the endoscopic procedure times [ mean 766 s ( range : 647-866 s ) for Group A vs 760 s ( range : 678-854 s ) for Group B , P = 0.88 ] .


The total gastric mucosal visibility score was also lower in Group A ( 4.91.5 vs 8.31.8 in Group B , P < 0.01 ) .


The addition of pronase to simethicone premedication resulted in clearer images during magnifying endoscopy and reduced the need for water flushes .


Our study tested the hypothesis that sodium ( Na ) - selenite expression treatment can reduce oxidative stress and increase plasma antioxidants , whereas modulating white blood cell antigen expression in severe sepsis .


Selenite is a well known cofactor of glutathione peroxidases and other antioxidant enzymes ; therefore , one may expect an antioxidant effect of treatment .


We randomized 40 severe septic patients into treatment and control groups .


Treatment group ( n = 21 ) received 1000-g/2 hours Na-selenite load , followed by a 1000-g/die medication .


Oxidative stress markers , including malondialdehyde , maximal free radical production , and plasma antioxidants : free sulfhydryl groups , glutathione levels , and superoxide dismutase and catalase enzyme activity were measured .


According to our results , the treatment regime successfully restored serum selenium levels .


Treatment group developed a significant malondialdehyde increase by the fifth study day , whereas reactive oxygen species production decreased significantly .


Reduced glutathione and plasma sulfhydryl groups showed no significant difference .


Treatment group showed deteriorated expression of CD11a and slight increase of CD49d expression on monocytes throughout our study .


Although our Na-selenite treatment regime successfully restored the selenium deficiency of severe septic patients , antioxidant and white blood cell antigen expression modulating effect of the therapy was not observed in our patient group .


Renal colic is typically characterized by the sudden onset of severe pain radiating from the flank to the groin and its acute management in emergency departments essentially aims at rapid pain relief .


Spasmofen ( ) is a brand of Amriya Pharmaceutical Industries in the form of rectal suppositories containing ketoprofen 100 mg and hyoscine butylbromide 10 mg .


This combination is intended for the rapid relief of severe colicky pain in the renal system , hepatobiliary system , or gastrointestinal tract .


This trial aims to compare a single-dose of Spasmofen rectal suppository to a single intravenous ( IV ) ketorolac tromethamine 30 mg/2 mL dose in patients with acute renal colic .


A total of 80 eligible consecutive patients presenting to the emergency departments of two medical centers with acute renal colic were included in the study .


Eligible patients who signed the informed consent were randomly assigned into two treatment groups : an experimental group ( Spasmofen group ) who received one Spasmofen rectal suppository plus an IV injection of 2 mL of normal saline solution ; and a control group ( ketorolac group ) who received one ketorolac 30 mg/2 mL ampoule IV plus one placebo suppository .


Treatment success , defined as a change in the verbal rating score from severe or moderate pain to none or mild at 60 minutes after the dose , was compared between groups using the chi-square/Fisher 's exact test .


Percentage reductions in visual pain analog scale ( VPAS ) scores at 15 and 60 minutes after the dose were compared between groups using the Z-test for proportions .


Successful treatment at 60 minutes occurred in 35 of 40 ( 87.5 % ) of Spasmofen-treated patients and in 33 of 40 ( 82.5 % ) of ketorolac-treated patients .


The difference was not statistically significant by Fisher 's exact test ( P = 0.755 ) .


The mean percentage reduction of VPAS after 15 minutes was 61.82 % in the Spasmofen-treated group and 64.76 % in the ketorolac-treated group .


The difference was also not statistically significant by the Z-test for proportions ( P = 0.795 ) .


Sixty minutes after being treated , Spasmofen was associated with a statistically significant greater reduction in VPAS ( mean % reduction = 92.36 % ) than ketorolac ( 75.06 % ; P = 0.0466 ) .


Single-dose Spasmofen rectal suppository might be a safe and effective first-aid treatment for the emergency department relief of acute renal colic .


Iosimenol 340 injection is a new isotonic iodinated contrast medium for X-ray angiography .


To investigate the pharmacokinetics and biotransformation , tolerability , and safety of Iosimenol 340 in healthy human subjects .


Twenty-four subjects were enrolled and randomized to receive either Iosimenol 340 ( 0.5 , 1.5 or 3.0 mL/kg ) or placebo ( 0.9 % saline ) .


In each dosing group , six subjects received Iosimenol 340 and two subjects received placebo .


Safety was assessed by physical examination , vital signs , electrocardiography , and laboratory tests .


Adverse events were recorded throughout the study up to 14 days after dosing .


Blood samples were collected from 10 min before until 48 h after the start of dosing and urine samples were collected from 15 min before until 96 h after the start of dosing .


Iosimenol was quantified in plasma and urine by measuring iodine concentrations with X-ray fluorescence .


High-performance liquid chromatography was used to assess iosimenol biotransformation .


Mean half-lives ( mean standard deviation [ SD ] ) of iosimenol were 0.17 0.08 h ( 10.2 4.8 min ) and 2.01 0.32 h for distribution and terminal elimination phases , respectively .


The apparent volume of distribution was 0.27 0.05 L/kg , indicating distribution to the extracellular fluid volume .


Iosimenol was excreted within 24 h without any sign of metabolic transformation .


Thirty-two adverse events were observed in 14 subjects .


All were mild or moderate , and were transient in nature .


Iosimenol was not metabolized , had a distribution volume corresponding to the extracellular space , and was rapidly excreted through the kidneys by glomerular filtration .


The area under the plasma concentration curve and the peak plasma concentration was proportional to dose , while clearance was independent of dose .


Iosimenol 340 was well tolerated .


Myoclonic movements are common problems during induction of anaesthesia with etomidate .


The myoclonus occurring after etomidate administration may represent a form of seizure .


Agonistic modulation of the opiate receptor may reduce seizures , and butorphanol acts in such a manner .


The aim of this randomised , double-blind , placebo-controlled clinical trial was to test our hypothesis that pre-treatment with butorphanol might reduce the incidence and severity of myoclonus induced by etomidate .


Patients ( 108 ) with American Society of Anaesthesiologists physical status I or II were randomly assigned to one of two groups to receive either 0.015 mg/kg of butorphanol ( n = 54 ) or saline ( n = 54 ) intravenously .


At two minutes after infusion of butorphanol or saline , 0.3 mg/kg etomidate was given .


The occurrence and severity ( observational score of 0-3 ) of myoclonus was assessed during 2 minutes after administration of etomidate .


For each patient , blood pressure ( BP ) , saturation of peripheral oxygen ( SpO ) , and heart rate ( HR ) were measured .


The incidence of myoclonus was significantly lower in Group Butorphanol than in Group Saline ( 13.0 % vs 79.6 % ; RR = 0.163 , 95 % CI : 0.081-0 .329 ; = 48.265 , p < 0.0001 ) .


The severity levels of myoclonic movement were also significantly lower in Group Butorphanol than in Group Saline ( p < 0.0001 ) .


Throughout the procedure , changes of BP , SpO , and HR did not differ between the groups .


There were no problems with bradycardia or hypotension .


Infusion of 0.015 mg/kg butorphanol 2 minutes before etomidate administration is effective for suppressing myoclonus induced by etomidate during induction of general anaesthesia .


Depressive symptoms occur frequently in Dutch society .


Recently a new method for treating depressive symptoms was introduced in the Netherlands .


The method , known as ` multi-moment non-invasive neurostimulation ' ( MNNS ) , involves presenting patients with a series of photographs , each picture having a positive valence .


The purpose of this method is to improve the mood of patients .


So far , however , the method has not been thoroughly tested .


To conduct a pilot study designed to compare the effectiveness of MNNS pictures with pictures from the International Affective Pictures System ( IAPS ) by means of a double-blind randomised controlled trial .


Thirty-three patients with depressive symptoms were randomly assigned to two groups , one representing the experimental condition ( MNNS ) and the other the control condition ( IAPS ) .


Patients were treated for six weeks in one mood-inductive session per week .


The severity of the patients ' depressive symptoms was assessed before the mood-induction treatment began and again at one week and at three months after the final session .


Each group showed a significant reduction in depressive symptoms .


There were no significant differences between the MNNS condition and the control condition with regard to the reduction of depressive symptoms over time .


There was a marked reduction in the depressive symptoms of the patients of both groups which had received short-term treatments involving the viewing of pictures with a positive valence .


This reduction was still apparent three months after the treatment .


The positive pictures presented in the MNNS method were found to be just as effective in reducing depressive symptoms as the positive pictures presented by the IAPS .


Randomized studies examining the effect of training of mental health professionals in suicide prevention guidelines are scarce .


We assessed whether professionals benefited from an e-learning supported Train-the-Trainer programme aimed at the application of the Dutch multidisciplinary suicide prevention guideline .


45 psychiatric departments from all over the Netherlands were clustered in pairs and randomized .


In the experimental condition , all of the staff of psychiatric departments was trained by peers with an e-learning supported Train-the-Trainer programme .


Guideline adherence of individual professionals was measured by means of the response to on-line video fragments .


Multilevel analyses were used to establish whether variation between conditions was due to differences between individual professionals or departments .


Multilevel analysis showed that the intervention resulted in an improvement of individual professionals .


At the 3 month follow-up , professionals who received the intervention showed greater guideline adherence , improved self-perceived knowledge and improved confidence as providers of care than professionals who were only exposed to traditional guideline dissemination .


Subgroup analyses showed that improved guideline adherence was found among nurses but not among psychiatrists and psychologists .


No significant effect of the intervention on team performance was found .


The ICT environment in departments was often technically inadequate when displaying the video clips clip of the survey .


This may have caused considerable drop-out and possibly introduced selection bias , as professionals who were strongly affiliated to the theme of the study might have been more likely to finish the study .


Our results support the idea that an e-learning supported Train-the-Trainer programme is an effective strategy for implementing clinical guidelines and improving care for suicidal patients .


Netherlands Trial Register ( NTR3092 www.trialregister.nl ) .


Participation in falls prevention activities by older people following presentation to the emergency department ( ED ) with a fall is suboptimal .


This randomised controlled trial ( RCT ) will test the RESPOND programme , an intervention designed to improve older persons ' participation in falls prevention activities through delivery of patient-centred education and behaviour change strategies .


A RCT at two tertiary referral EDs in Melbourne and Perth , Australia .


528 community-dwelling people aged 60-90years presenting to the ED with a fall and discharged home will be recruited .


People who require an interpreter or hands-on assistance to walk ; live in residential aged care or > 50km from the trial hospital ; have terminal illness , cognitive impairment , documented aggressive behaviour or a history of psychosis ; are receiving palliative care or are unable to use a telephone will be excluded .


Participants will be randomly allocated to the RESPOND intervention or standard care control group .


RESPOND incorporates ( 1 ) a home-based risk factor assessment ; ( 2 ) education , coaching , goal setting and follow-up telephone support for management of one or more of four risk factors with evidence of effective interventions and ( 3 ) healthcare provider communication and community linkage delivered over 6months .


Primary outcomes are falls and fall injuries per person-year .


RESPOND builds on prior falls prevention learnings and aims to help individuals make guided decisions about how they will manage their falls risk .


Patient-centred models have been successfully trialled in chronic and cardiovascular disease ; however , evidence to support this approach in falls prevention is limited .


The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12614000336684 ) .


Community-acquired pneumonia ( CAP ) is the third-leading infectious cause of death worldwide .


The standard treatment of CAP has not changed for the past fifty years and its mortality and morbidity remain high despite adequate antimicrobial treatment .


Systemic corticosteroids have anti-inflammatory effects and are therefore discussed as adjunct treatment for CAP .


Available studies show controversial results , and the question about benefits and harms of adjunct corticosteroid therapy has not been conclusively resolved , particularly in the non-critical care setting .


This randomized multicenter study compares a treatment with 7days of prednisone 50mg with placebo in adult patients hospitalized with CAP independent of severity .


Patients are screened and enrolled within the first 36hours of presentation after written informed consent is obtained .


The primary endpoint will be time to clinical stability , which is assessed every 12hours during hospitalization .


Secondary endpoints will be , among others , all-cause mortality within 30 and 180days , ICU stay , duration of antibiotic treatment , disease activity scores , side effects and complications , value of adrenal function testing and prognostic hormonal and inflammatory biomarkers to predict outcome and treatment response to corticosteroids .


Eight hundred included patients will provide an 85 % power for the intention-to-treat analysis of the primary endpoint .


This largest to date double-blind placebo-controlled multicenter trial investigates the effect of adjunct glucocorticoids in 800 patients with CAP requiring hospitalization .


It aims to give conclusive answers about benefits and risks of corticosteroid treatment in CAP .


The inclusion of less severe CAP patients will be expected to lead to a relatively low mortality rate and survival benefit might not be shown .


However , our study has adequate power for the clinically relevant endpoint of clinical stability .


Due to discontinuing glucocorticoids without tapering after seven days , we limit duration of glucocorticoid exposition , which may reduce possible side effects .


7 September 2009 on ClinicalTrials.gov : NCT00973154 .


KM-023 is a new second-generation nonnucleoside reverse-transcriptase inhibitor that is under development for the treatment of human immunodeficiency virus ( HIV ) type 1 infection .


This study determined KM-023 tolerability and pharmacokinetic characteristics in healthy subjects .


A randomized , double-blinded , placebo-controlled , dose-escalation study was conducted in 80 healthy South Korean male volunteers .


The subjects were allocated to single - or multiple-dose ( once daily for 7 days ) groups that received 75 , 150 , 300 , or 600 mg drug or placebo in a 4:1 ratio .


Safety and pharmacokinetic assessments were performed during the study .


Plasma and urine concentrations were quantified using liquid chromatography-tandem mass spectrometry .


The average maximum concentration ( Cmax ) and area under the concentration-time curve from time 0 to infinity ( AUC ) values of KM-023 for the 75-600 mg doses in the single-dose study ranged from 440.2 ng/mL to 1,245.4 ng/mL and 11,142.4 ng h/mL to 33,705.6 ng h/mL , respectively .


Values of the mean Cmax at a steady state and AUC within the dosing interval ranged from 385.1 ng/mL to 1,096.7 ng/mL and 3,698.9 ng h/mL to 10,232.6 ng h/mL , respectively , following 75-600 mg doses in the multiple-dose study .


Dose proportionality was not observed for KM-023 .


KM-023 showed a 0.6-fold accumulation after multiple doses in the 600 mg dose group .


The mean half-life values ranged between 20.7 and 31.2 hours .


KM-023 was generally well tolerated without serious adverse events .


KM-023 demonstrated dose - and time-dependent nonlinear pharmacokinetic characteristics after single or multiple doses over a dose range ( 75-600 mg ) in healthy subjects .


KM-023 showed favorable tolerability in this study .


This Phase I clinical trial information can be used to design further clinical studies appropriately to evaluate KM-023 in patients with HIV-1 infection .


This trial assessed the efficacy of cotrimoxazole lock solution in reducing catheter-related blood stream infections ( CRBSIs ) among hemodialysis ( HD ) patients who were dialyzed using tunneled catheters .


Patients randomly received either heparin ( 2500 U/ml ) ( control group ) or a mixture of 10 mg/ml cotrimoxazole ( based on trimethoprim ) and 2500 U/ml heparin ( antibiotic group ) as catheters lock solution .


Compared with the control group , CRBSIs rates per 1000 catheter-days was significantly lower ( 0.58 vs 4.4 events ; p = 0.002 ) and cumulative infection-free catheter survival was significantly higher ( log rank statistic 5.88 ; p = 0.015 ) in the antibiotic group .


There were no statistical differences regarding incidences of catheter removal ( 8.7 % in the antibiotic group vs 22 % in the control group ; p = 0.116 ) or thrombosis ( 2.2 % in the antibiotic group vs 9.8 % in the control group ; p = 0.129 ) between the two groups .


cotrimoxazole containing catheter lock solution is effective in reducing CRBSIs incidence and prolonging dialysis catheter survival in HD patients .


There is increasing community and government recognition of the magnitude and impact of adolescent depression .


Family based interventions have significant potential to address known risk factors for adolescent depression and could be an effective way of engaging adolescents in treatment .


The evidence for family based treatments of adolescent depression is not well developed .


The objective of this clinical trial is to determine whether a family based intervention can reduce rates of unipolar depressive disorders in adolescents , improve family functioning and engage adolescents who are reluctant to access mental health services .


The Family Options study will determine whether a manualized family based intervention designed to target both individual and family based factors in adolescent depression ( BEST MOOD ) will be more effective in reducing unipolar depressive disorders than an active ( standard practice ) control condition consisting of a parenting group using supportive techniques ( PAST ) .


The study is a multicenter effectiveness randomized controlled trial .


Both interventions are delivered in group format over eight weekly sessions , of two hours per session .


We will recruit 160 adolescents ( 12 to 18 years old ) and their families , randomized equally to each treatment condition .


Participants will be assessed at baseline , eight weeks and 20 weeks .


Assessment of eligibility and primary outcome will be conducted using the KID-SCID structured clinical interview via adolescent and parent self-report .


Assessments of family mental health , functioning and therapeutic processes will also be conducted .


Data will be analyzed using Multilevel Mixed Modeling accounting for time x treatment effects and random effects for group and family characteristics .


This trial is currently recruiting .


Challenges in design and implementation to-date are discussed .


These include diagnosis and differential diagnosis of mental disorders in the context of adolescent development , non-compliance of adolescents with requirements of assessment , questionnaire completion and treatment attendance , breaking randomization , and measuring the complexity of change in the context of a family-based intervention .


Australia and New Zealand Clinical Trials Registry Title : engaging youth with high prevalence mental health problems using family based interventions ; number 12612000398808 .


Prospectively registered on 10 April 2012 .


Obesity is a leading risk factor for endometrial cancer ( EC ) , particularly Type I forms , which are increasing in the U.S. Although death rates from most cancers have been decreasing , overall mortality in EC is increasing in the U.S. EC survivors ' poor fitness combined with their surgical treatments may make weight loss particularly challenging .


High intensity exercise increases neurotrophins and neurological reward via altered striatal dopamine in animals , and , in humans , chronic high intensity exercise enhances meal-induced satiety and may reduce hedonic eating .


`` Assisted '' exercise , a mode of exercise whereby a patient 's voluntary exercise rate is augmented mechanically , may modulate brain dopamine levels in Parkinson 's Disease patients but has not been previously evaluated as a treatment for obesity .


We describe the rationale and design of the REWARD trial , which has the overarching goal of randomizing 120 obese EC survivors to `` assisted '' or voluntary rate cycling to evaluate the efficacy of `` assisted '' exercise in enhancing and sustaining weight loss .


Patients in both arms will receive 3 days/week of supervised exercise and 1 day/week of a group dietary behavioral intervention for 16 weeks and , then , will be followed for 6 months .


The primary outcome is weight loss .


Secondary outcomes include measures for body composition , fitness , eating behavior , exercise motivation and , quality of life as well as cognition and food reward and motivation as assessed by functional magnetic resonance imaging ( fMRI ) tasks .


If successful , the REWARD program could be extended to help sustain weight loss in obese cancer and non-cancer patients .


The objective of this study is to evaluate the effectiveness of a simple dyadic ( person with dementia and their main carer ) exercise regimen as a therapy for the behavioural and psychological symptoms of dementia .


A two arm , pragmatic , randomised , controlled , single-blind , parallel-group trial of a dyadic exercise regimen ( individually tailored walking regimen designed to become progressively intensive and last between 20-30min , at least five times per week ) .


Community-dwelling individuals with ICD-10 confirmed dementia with the following : clinically significant behavioural and psychological symptoms , a carer willing and able to co-participate in the exercise regimen , and no physical conditions or symptoms that would preclude exercise participation were invited by mental health or primary care services into the study .


One hundred and thirty-one dyads were recruited to this study .


There was no significant difference in Behavioural and Psychological Symptoms as measured by the Neuropsychiatric Inventory at week 12 between the group receiving the dyadic exercise regimen and those that did not ( adjusted difference in means ( intervention minus control ) = -1.53 , p = 0.6 , 95 % CI [ -7.37 , 4.32 ] ) .


There was a significant between-group difference in caregiver 's burden as measured by the Zarit Caregiver Burden Inventory at week 12 ( OR = 0.18 , p = 0.01 , CI [ 0.05 , 0.69 ] ) favouring the exercise group .


This study found that regular simple exercise does not appear to improve the behavioural and psychological symptoms of dementia , but did seem to attenuate caregiver burden .


Further study to improve exercise uptake are needed .


Consumption of flavonoid-rich foods such as cocoa and tea may reduce cardiovascular disease risk .


The flavonoids epicatechin ( in cocoa and tea ) and quercetin ( in tea ) probably play a role by reducing endothelial dysfunction and inflammation , 2 main determinants of atherosclerosis .


We studied the effects of supplementation of pure epicatechin and quercetin on biomarkers of endothelial dysfunction and inflammation .


Thirty-seven apparently healthy ( pre ) hypertensive men and women ( 40-80 y ) participated in a randomized , double-blind , placebo-controlled crossover trial .


Participants ingested ( - ) - epicatechin ( 100 mg/d ) , quercetin-3-glucoside ( 160 mg/d ) , or placebo capsules for a period of 4 wk , in random order .


Plasma biomarkers of endothelial dysfunction and inflammation were measured at the start and end of each 4-wk intervention period .


The differences in changes over time between the intervention and placebo periods ( intervention - placebo ) were calculated and tested with a linear mixed model for repeated measures .


Epicatechin changed epicatechin - placebo for soluble endothelial selectin ( sE-selectin ) by -7.7 ng/mL ( 95 % CI : -14.5 , -0.83 ; P = 0.03 ) but did not significantly change this difference ( -0.30 ; 95 % CI : -0.61 , 0.01 ; P = 0.06 ) for the z score for endothelial dysfunction .


Quercetin changed quercetin - placebo for sE-selectin by -7.4 ng/mL ( 95 % CI : -14.3 , -0.56 ; P = 0.03 ) , that for IL-1 by -0.23 pg/mL ( 95 % CI : -0.40 , -0.06 ; P = 0.009 ) , and that for the z score for inflammation by -0.33 ( 95 % CI : -0.60 , -0.05 ; P = 0.02 ) .


In ( pre ) hypertensive men and women , epicatechin may contribute to the cardioprotective effects of cocoa and tea through improvements in endothelial function .


Quercetin may contribute to the cardioprotective effects of tea possibly by improving endothelial function and reducing inflammation .


This trial was registered at clinicaltrials.gov as NCT01691404 .


Muscle passive contraction of lower limb by neuromuscular electrostimulation ( NMES ) is frequently used in chronic heart failure ( CHF ) patients but no data are available concerning its action on sympathetic activity .


However , Transcutaneous Electrical Nerve Stimulation ( TENS ) is able to improve baroreflex in CHF .


The primary aim of the present study was to investigate the acute effect of TENS and NMES compared to Sham stimulation on sympathetic overactivity as assessed by Muscle Sympathetic Nerve Activity ( MSNA ) .


We performed a serie of two parallel , randomized , double blinded and sham controlled protocols in twenty-two CHF patients in New York Heart Association ( NYHA ) Class III .


Half of them performed stimulation by TENS , and the others tested NMES .


Compare to Sham stimulation , both TENS and NMES are able to reduce MSNA ( 63.5 3.5 vs 69.7 3.1 bursts / min , p < 0.01 after TENS and 51.6 3.3 vs 56.7 3.3 bursts / min , p < 0 , 01 after NMES ) .


No variation of blood pressure , heart rate or respiratory parameters was observed after stimulation .


The results suggest that sensory stimulation of lower limbs by electrical device , either TENS or NMES , could inhibit sympathetic outflow directed to legs in CHF patients .


These properties could benefits CHF patients and pave the way for a new non-pharmacological approach of CHF .


Although the majority of smokers are ambivalent about quitting , few treatments specifically target smokers lacking motivation to quit in the near future .


Most existing interventions are instead predicated on the belief that active treatments should only be distributed to smokers interested in quitting , a largely untested assumption .


In the current clinical trial ( N = 157 ) , motivated smokers wanting to quit in the next 30 days were given a 2-week nicotine replacement therapy ( NRT ) sample and a referral to a quitline ( Group MNQ ) , while unmotivated smokers were randomized to receive the same treatment ( Group UNQ ) or a quitline referral only ( Group UQ ) .


Participants were tracked via telephone for 3 months to assess quitting behaviors and smoking reduction .


Groups significantly differed across all comparisons with regard to incidence of any quit attempt ( MNQ : 77 % , UNQ : 40 % , UQ : 18 % , p < .05 ) and any 24-hr quit attempts ( 62 % , 32 % , 16 % , p < .05 ) .


Clinically meaningful differences emerged in the rates of floating ( 19 % , 17 % , 6 % ) and point prevalence abstinence ( 17 % , 15 % , 5 % ) .


Compared to participants in Group UQ ( 11 % ) , a greater proportion of participants in Group MNQ ( 48 % , p = .01 ) and Group UNQ ( 31 % , p = .01 ) reduced their daily cigarette consumption by at least half .


Proxy measures of cessation readiness ( e.g. , motivation ) favored participants receiving active forms of treatment .


Providing NRT samples engaged both motivated and unmotivated smokers into the quitting process and produced positive changes in smoking outcomes .


This suggests that motivation should not be considered a necessary precondition to receiving treatment .


Emerging antimalarial drug resistance in mobile populations remains a significant public health concern .


We compared two regimens of dihydroartemisinin-piperaquine in military and civilians on the Thai-Cambodian border to evaluate national treatment policy .


Efficacy and safety of two and three-day regimens of dihydroartemisinin-piperaquine were compared as a nested open-label evaluation within a malaria cohort study in 222 otherwise healthy volunteers ( 18 % malaria-infected at baseline ) .


The first 80 volunteers with slide-confirmed Plasmodium falciparum or vivax malaria were randomized 1:1 to receive either regimen ( total dose 360 mg dihydroartemisinin and 2880 mg piperaquine ) and followed weekly for up to 6 months .


The primary endpoint was malaria recurrence by day 42 .


Volunteers with vivax infection received primaquine at study discharge with six months follow-up .


Eighty patients ( 60 vivax , 15 falciparum , and 5 mixed ) were randomized to dihydroartemisinin-piperaquine .


Intention-to-treat all-species efficacy at Day 42 was 85 % for the two-day regimen ( 95 % CI 69-94 ) and 90 % for the three-day regimen ( 95 % CI 75-97 ) .


PCR-adjusted falciparum efficacy was 75 % in both groups with nearly half ( 45 % ) still parasitemic at Day 3 .


Plasma piperaquine levels were comparable to prior published reports , but on the day of recrudescence were below measurable in vitro piperaquine IC50 levels in all falciparum treatment failures .


In the brief period since introduction of dihydroartemisinin-piperaquine , there is early evidence suggesting declining efficacy relative to previous reports .


Parasite IC50 levels in excess of plasma piperaquine levels seen only in treatment failures raises concern for clinically significant piperaquine resistance in Cambodia .


These findings warrant improved monitoring of clinical outcomes and follow-up , given few available alternative drugs .


ClinicalTrials.gov NCT01280162 .


Screening for lung cancer has the potential to reduce mortality , but in addition to detecting aggressive tumors , screening will also detect indolent tumors that otherwise may not cause clinical symptoms .


These overdiagnosis cases represent an important potential harm of screening because they incur additional cost , anxiety , and morbidity associated with cancer treatment .


To estimate overdiagnosis in the National Lung Screening Trial ( NLST ) .


We used data from the NLST , a randomized trial comparing screening using low-dose computed tomography ( LDCT ) vs chest radiography ( CXR ) among 53452 persons at high risk for lung cancer observed for 6.4 years , to estimate the excess number of lung cancers in the LDCT arm of the NLST compared with the CXR arm .


We calculated 2 measures of overdiagnosis : the probability that a lung cancer detected by screening with LDCT is an overdiagnosis ( PS ) , defined as the excess lung cancers detected by LDCT divided by all lung cancers detected by screening in the LDCT arm ; and the number of cases that were considered overdiagnosis relative to the number of persons needed to screen to prevent 1 death from lung cancer .


During follow-up , 1089 lung cancers were reported in the LDCT arm and 969 in the CXR arm of the NLST .


The probability is 18.5 % ( 95 % CI , 5.4 % -30.6 % ) that any lung cancer detected by screening with LDCT was an overdiagnosis , 22.5 % ( 95 % CI , 9.7 % -34.3 % ) that a non-small cell lung cancer detected by LDCT was an overdiagnosis , and 78.9 % ( 95 % CI , 62.2 % -93.5 % ) that a bronchioalveolar lung cancer detected by LDCT was an overdiagnosis .


The number of cases of overdiagnosis found among the 320 participants who would need to be screened in the NLST to prevent 1 death from lung cancer was 1.38 .


More than 18 % of all lung cancers detected by LDCT in the NLST seem to be indolent , and overdiagnosis should be considered when describing the risks of LDCT screening for lung cancer .


The portion size of food is a determinant of energy intake , linking with obese traits .


A healthy plate for portion control has recently been made in a Japanese style .


The aim of the current study was to assess the efficacy of a lifestyle intervention program using the Japanese-style healthy plate on weight reduction in overweight and obese diabetic Japanese subjects .


We randomized overweight and obese diabetic subjects ( n = 19 , 10 women ) into an intervention group including educational classes on lifestyle modification incorporating the healthy plate ( n = 10 ) or a waiting-list control group ( n = 9 ) .


The intervention period was three months , and the educational classes using the healthy plate were conducted monthly in a group session for the intervention group .


The body weight , blood glycemic and metabolic measures , and psychosocial variables were measured at the baseline and after the 3-month intervention in both groups .


The impression of the intervention was interviewed using a structured questionnaire .


There was one drop-out in the control group .


No adverse events were reported in the groups .


Subjects in the intervention group had a greater weight change from baseline to the end of the 3-month intervention period ( -3.7 + / - 2.5 [ SD ] kg in the intervention group vs. -0.1 + / - 1.4 kg in the control group , P = 0.002 ) .


Most subjects recorded that the use of a healthy plate could be recommended to other people .


The lifestyle intervention program using the Japanese-style healthy plate , which was developed for portion control , may effectively reduce body weight in overweight and obese diabetic subjects in Japan .


Further studies are needed to establish the efficacy of this methodology on weight management .


In surgical procedures , obesity is a risk factor for the onset of intra and postoperative respiratory complications .


Determine what moment of application of positive pressure brings better benefits on lung function , incidence of atelectasis and diaphragmatic excursion , in the preoperative , intraoperative or immediate postoperative period .


Randomized , controlled , blinded study , conducted in a hospital and included subjects with BMI between 40 and 55 kg/m2 , 25 and 55 years , underwent bariatric surgery by laparotomy .


They were underwent preoperative and postoperative evaluations .


They were allocated into four different groups : 1 ) Gpre : treated with positive pressure in the BiPAP mode ( Bi-Level Positive Airway Pressure ) before surgery for one hour ; 2 ) Gpos : BIPAP after surgery for one hour ; 3 ) Gintra : PEEP ( Positive End Expiratory Pressure ) at 10 cmH2O during the surgery ; 4 ) Gcontrol : only conventional respiratory physiotherapy .


The evaluation consisted of anthropometric data , pulmonary function tests and chest radiography .


Were allocated 40 patients , 10 in each group .


There were significant differences for the expiratory reserve volume and percentage of the predicted expiratory reserve volume , in which the groups that received treatment showed a smaller loss in expiratory reserve volume from the preoperative to postoperative stages .


The postoperative radiographic analysis showed a 25 % prevalence of atelectasis for Gcontrol , 11.1 % for Gintra , 10 % for Gpre , and 0 % for Gpos .


There was no significant difference in diaphragmatic mobility amongst the groups .


The optimal time of application of positive pressure is in the immediate postoperative period , immediately after extubation , because it reduces the incidence of atelectasis and there is reduction of loss of expiratory reserve volume .


Biomarkers of micronutrient status are needed to best define deficiencies and excesses of essential nutrients .


We evaluated several supporting biomarkers of vitamin A status in Zambian children to determine whether any of the biomarkers were consistent with high liver retinol stores determined by using retinol isotope dilution ( RID ) .


A randomized , placebo-controlled , biofortified maize efficacy trial was conducted in 140 rural Zambian children from 4 villages .


A series of biomarkers were investigated to better define the vitamin A status of these children .


In addition to the assessment of total-body retinol stores ( TBSs ) by using RID , tests included analyses of serum carotenoids , retinyl esters , and pyridoxal-5 ' - phosphate ( PLP ) by using high-pressure liquid chromatography , retinol-binding protein by using ELISA , and alanine aminotransferase ( ALT ) activity by using a colorimetric assay .


Children ( n = 133 ) were analyzed quantitatively for TBSs by using RID .


TBSs , retinyl esters , some carotenoids , and PLP differed by village site .


Serum carotenoids were elevated above most nonintervened reference values for children .


- Carotene , - carotene , and lutein values were > 95th percentile from children in the US NHANES III , and 13 % of children had hypercarotenemia ( defined as total carotenoid concentration > 3.7 mol/L ) .


Although only 2 % of children had serum retinyl esters > 10 % of total retinol plus retinyl esters , 16 % of children had > 5 % as esters , which was consistent with high liver retinol stores .


Ratios of serum retinol to retinol-binding protein did not deviate from 1.0 , which indicated full saturation .


ALT activity was low , which was likely due to underlying vitamin B-6 deficiency , which was confirmed by very low serum PLP concentrations .


The finding of hypervitaminosis A in Zambian children was supported by high circulating concentrations of carotenoids and mildly elevated serum retinyl esters .


ALT-activity assays may be compromised with co-existing vitamin B-6 deficiency .


Nutrition education to improve intakes of whole grains and animal-source foods may enhance vitamin B-6 status in Zambians .


Surgical site infection ( SSI ) is the second most common type of nosocomial infections in the United States .


In Uruguay , the incidence after prostatectomies is 2.6 % .


The aim of our study was to compare the efficacy of two skin antiseptics and to determine possible risk factors for SSI in patients undergoing surgery for benign prostatic hyperplasia ( BPH ) .


A randomized trial included 70 patients operated on for BPH , of whom 56 ( 80 % ) underwent open surgery .


Patients were treated by the same surgical team in a tertiary general hospital that is a referral center for patients with urologic diseases .


Skin antisepsis was performed randomly using either 0.5 % povidone-iodine or chlorhexidine in an alcohol base ( Chemisol ( ) ) .


Possible risk factors investigated were age , renal dysfunction , bladder stones , preoperative urinary catheter , positive preoperative urine culture , operative time and technique , and vesicocutaneous fistula .


Of all patients , 41 ( 59 % ) had a urinary catheter preoperatively .


Urine cultures were positive in 31 patients , of whom 29 ( 94 % ) had a urinary catheter .


Surgical site infection occurred in 10 patients ( 18 % ) , and 100 % of the causative microorganisms were gram-negative bacteria characteristic of the urinary flora .


The type of antiseptic did not affect the risk of SSI ( p = 1.00 ) .


The most important risk factor for infection was the presence of a urinary catheter preoperatively ( p = 0.003 ) ; also significant were the formation of a vesicocutaneous fistula ( p = 0.008 ) , increasing age ( p = 0.02 ) , and the presence of a positive preoperative urine culture ( p = 0.03 ) .


In a cohort of patients submitted to open prostatectomy , SSI was not related to the type of antiseptic .


The main risk factor was the presence of a urinary catheter preoperatively .


All microorganisms isolated from the SSIs were characteristic of urinary tract infections .


To evaluate the conception rate to fixed-time artificial insemination ( FTAI ) of two oestrus synchronisation programmes in dairy heifers on eight farms over 2 years .


The study was conducted in 2008 and 2010 on eight farms near Palmerston North , New Zealand .


Nulliparous Friesian and FriesianJersey heifers ( 13-15 months of age ) were randomly allocated to one of two oestrus synchronisation programmes .


Group 1 ( GPG+P 4 ; n = 330 ) , received gonadotrophin-releasing hormone ( GnRH ) I/M on Day 0 , a progesterone ( P4 ) - releasing intravaginal device from Days 0-7 , prostaglandin F2 ( PGF ) I/M on Day 7 and a second dose of GnRH at the time of FTAI on Day 9 .


The second group ( P4 + PGF ; n = 343 ) received a P4-releasing intravaginal device from Days 0-7 , PGF on Day 6 and FTAI on Day 9 .


Pregnancy was diagnosed from Days 42-52 by transrectal ultrasonography .


The overall conception rate was 52.4 % and 54.8 % for the GPG+P 4 and P4 + PGF groups , respectively .


The odds of conception for the two treatments were not different ( OR = 0.90 ; 95 % CI = 0.67-1 .23 ) , nor was there any difference between groups in different years ( p = 0.58 ) .


Farm affected conception rate ( p = 0.002 ) , but there was no interaction with treatment ( p = 0.92 ) .


This study has shown that an alternative synchronisation programme can produce similar results in terms of conception rate to the GPG+P 4 treatment , currently commonly used in heifers .


More research is required to establish whether other modifications to the GPG+P 4 programme can produce similar results at lower costs , and to identify and quantify farm factors which affect the economic benefit of heifer synchronisation .


This study indicated that synchronising heifers with P4 and PGF resulted in conception rates equivalent to those resulting from a GPG+P 4 treatment , but with reduced drug costs .


However , because heifers in the GPG+P 4 group received the second GnRH injection at the time of AI , they needed only three yardings as opposed to the four required for the heifers treated with P4 and PGF .


Thus , the choice of programme for an individual farm will depend on that farm 's circumstances , in particular the cost of yarding the heifers .


Efficacy and safety are the two considerations when characterising the effects of a new therapy .


We sought to apply an innovative method of assessing the benefit-risk balance using data from a completed randomised controlled trial that compared erlotinib vs placebo added to gemcitabine in patients with advanced pancreatic cancer ( NCIC CTG PA. 3 ) .


We applied generalised pairwise comparisons with several prioritised outcome measures ( e.g. , one or more benefit outcomes and one or more risk outcomes ) .


Here , the first priority outcome was overall survival ( OS ) time .


Differences in OS that exceeded 2 months were considered clinically meaningful .


The second priority outcome was toxicity .


The overall treatment effect was quantified using the proportion in favour of erlotinib , which can be interpreted as the net proportion of patients who have a better overall outcome with erlotinib as compared with placebo .


Sensitivity analyses were performed .


In this trial 569 patients were randomly assigned in a 1:1 ratio to receive gemcitabine plus either erlotinib or a matched placebo .


Overall , the method indicated no statistically significant overall treatment effect in favour of erlotinib ; if anything , the point estimate of the net proportion leaned in favour of the placebo group ( overall proportion in favour of erlotinib = -3.6 % , 95 % CI , -14.2 - 7.1 % ; P = 0.51 ) .


The net proportion was never in favour of the erlotinib group throughout all sensitivity analyses .


Generalised pairwise comparisons make it possible to assess the benefit-risk balance of new treatments using a single statistical test for any number of prioritised outcomes .


The benefit-risk assessment was not in favour of adding erlotinib to gemcitabine for the treatment of patients with advanced pancreatic cancer .


Sedation using intranasal dexmedetomidine is a convenient and well-tolerated technique .


This study evaluated the sedative efficacy of intranasal dexmedetomidine in combination with patient-controlled sedation ( PCS ) for upper gastrointestinal endoscopy .


In this double-blind , randomised , controlled trial , 50 patients received either intranasal dexmedetomidine 1.5 g/kg ( dexmedetomidine group ) or intranasal saline ( placebo group ) 1h before the procedure .


PCS with propofol and alfentanil was provided for rescue sedation .


Additional sedative consumption , perioperative sedation scores using Observer 's Assessment of Alertness/Sedation ( OAA/S ) scale , recovery , vital signs , adverse events and patient satisfaction were assessed .


Total consumption of PCS propofol and alfentanil was significantly less in the dexmedetomidine than placebo group with a mean difference of -13.8 mg propofol ( 95 % confidence interval -27.3 to -0.3 ) and -34.5 g alfentanil ( 95 % confidence interval -68.2 to -0.7 ) at the completion of the procedure ( P = 0.044 ) .


Weighted areas under the curve ( AUCw ) of OAA/S scores were significantly lower in the dexmedetomidine group before , during and after procedures ( P < 0.001 , P = 0.024 and P = 0.041 respectively ) .


AUCw of heart rate and systolic blood pressure were also significantly lower during the procedure ( P = 0.007 and P = 0.022 respectively ) with dexmedetomidine .


There was no difference in recovery , side effects or satisfaction .


Intranasal dexmedetomidine with PCS propofol and alfentanil confers deeper perioperative clinical sedation with significantly less use of additional sedatives during upper gastrointestinal endoscopy .


This split-mouth , double-blind randomized controlled trial evaluated radiographic changes in infrabony defects treated with open flap debridement ( OFD ) or OFD associated with enamel matrix derivative ( EMD ) after a 24-month follow-up .


The radiographic distance from the CEJ to the bottom of the defect ( BD ) was considered the primary outcome .


CEJ-BC and defect angle were secondary outcomes .


Ten patients presenting 2 or more defects were selected .


An individualized film holder was used to take standardized radiographs of the 43 defects , at baseline and after 24months .


Images were digitized and used to measure the distances from the cemento-enamel junction ( CEJ ) to the alveolar crest ( AC ) , CEJ to the bottom of the defect ( BD ) and infrabony defect angle .


Statistical analysis was performed in SPSS for Windows ( version 5.2 ) .


Paired samples t test was used to compare test and control groups and to evaluate changes within each group .


The level of significance was set at = 0.05 % .


After 24months , a significant crestal bone loss was observed for EMD ( 1.01 mm ; p = 0.049 ) but not for OFD ( 0.14 mm ; p = 0.622 ) .


However , no differences were detected between groups ( p = 0.37 ) .


Reduction of the bone defect depth was significant for OFD ( 0.70 mm ; p = 0.005 ) but not for EMD ( 0.04 mm ; p = 0.86 ) , while no differences were detected between them ( p = 0.87 ) .


Both EMD ( 0.69 ; p = 0.82 ) and OFD ( 5.71 ; p = 0.24 ) showed an improvement in defect angle measurements but no significant differences were observed after 24months or between the groups ( p = 0.35 ) .


Linear radiographic analysis was not able to demonstrate superiority of EMD treated infrabony defects when compared to ODF after 24months .


ClinicalTrials.gov : NCT02195765 .


Registered 17 July 2014 .


To develop a mathematical model to adjust the timing of computed tomography ( CT ) scans with the hazard of cancer recurrence in time to facilitate early detection of cancer recurrence .


The clinical data were extracted from the randomized Scandinavian Sarcoma Group ( SSG ) XVIII/Arbeitsgemeinschaft Internistische Onkologie ( AIO ) trial database .


The SSG XVIII/AIO trial was registered ( trial no .


NCT00116935 ) and approved by the national or institutional review boards .


In the trial , 1 - and 3-year durations of adjuvant imatinib mesylate in the treatment of patients with gastrointestinal stromal tumor ( GIST ) were compared .


A nonhomogeneous Poisson model with a piecewise log-constant hazard in time that accounts for the nonlinear pattern of GIST recurrence was applied to tumor site , mitotic count , and recurrence data .


The optimal times to obtain follow-up CT scans were computed by modifying the frequency of CT scans with the hazard of tumor recurrence in time .


The hazard-adjusted follow-up schedules were compared with the National Comprehensive Cancer Network ( NCCN ) guidelines of the United States , which suggest imaging with CT at intervals of 3-6 months for 3-5 years and then annually .


Optimized timing of CT scans on the basis of hazard of recurrence resulted in follow-up schedule options where CT is performed more sparsely than in the NCCN guidelines during adjuvant imatinib administration and more frequently , at approximately 3-month intervals , during the first 2 years that follow imatinib discontinuation when the risk of recurrence was the greatest .


The number of CT scans could be reduced by a median of 31 % ( from 13 to nine ) compared with the standard schedules within the first 6 years of follow-up without increasing the delay in recurrence detection .


Detection of GIST recurrence may be enhanced by adjusting the timing of the CT scans with the hazard of recurrence .


The method may be applicable to other human tumor types .


Online supplemental material is available for this article .


In the field of intelligence research , it has been shown that some people conceive intelligence as a fixed trait that can not be changed ( entity beliefs ) , whereas others conceive it as a malleable trait that can be developed ( incremental beliefs ) .


What about writing ?


Do people hold similar implicit theories about the nature of their writing ability ?


Furthermore , are these beliefs likely to influence students ' response to a writing intervention ?


We aimed to develop a scale to measure students ' implicit theories of writing ( pilot study ) and to test whether these beliefs influence strategy-instruction effectiveness ( intervention study ) .


In the pilot and intervention studies participated , respectively , 128 and 192 students ( Grades 5-6 ) .


Based on existing instruments that measure self-theories of intelligence , we developed the Implicit Theories of Writing ( ITW ) scale that was tested with the pilot sample .


In the intervention study , 109 students received planning instruction based on the self-regulated strategy development model , whereas 83 students received standard writing instruction .


Students were evaluated before , in the middle , and after instruction .


ITW 's validity was supported by piloting results and their successful cross-validation in the intervention study .


In this , intervention students wrote longer and better texts than control students .


Moreover , latent growth curve modelling showed that the more the intervention students conceived writing as a malleable skill , the more the quality of their texts improved .


This research is of educational relevance because it provides a measure to evaluate students ' implicit theories of writing and shows their impact on response to intervention .


Acetaminophen ( APAP ) by oral or intravenous ( iv ) routes is used for mild to moderate pain but may take time to be effective .


When fast relief is required and/or oral or iv routes are not available because of the patient 's condition , the transmucosal route may be an alternative .


A new transmucosal/buccal ( b ) pharmaceutical form of APAP dissolved in 50 % wt alcohol is compared with other routes of administration .


Two consecutive randomized , crossover , double-blind clinical trials ( CT1 : NCT00982215 and CT2 : NCT01206985 ) included 16 healthy volunteers .


CT1 compared the pharmacology of 250 mg bAPAP with 1 g iv APAP .


CT2 compared the pharmacodynamics of 125 mg bAPAP with 1 g iv and 125 mg sublingual ( s ) APAP .


Mechanical pain thresholds are recorded in response to mechanical stimuli applied on the forearm several times during 120 minutes .


The objective is to compare the time of onset of antinociception and the antinociception ( area under the curve ) between the routes of administration with analysis of variance ( significance P < 0.05 ) .


bAPAP has a faster time of antinociception onset ( 15 minutes , P < 0.01 ) and greater antinociception at 50 minutes ( P < 0.01 , CT1 ) and 30 minutes ( P < 0.01 , CT2 ) than ivAPAP and sAPAP .


All routes are similar after 50 minutes .


bAPAP has a faster antinociceptive action in healthy volunteers .


This attractive alternative to other routes would be useful in situations where oral or iv routes are not available .


This finding must now be confirmed in patients suffering from acute pain of mild and moderate intensity .


To compare toric intraocular lens implantation ( Toric-IOL ) with peripheral corneal relaxing incisions ( PCRIs ) for astigmatism correction in patients undergoing cataract surgery .


54 patients ( 54 eyes ) with more than 0.75 diopter ( D ) of preexisting corneal astigmatism were classified as group A ( 0.75-1 .50 D ) or group B ( 1.75-2 .50 D ) .


The patients were randomized to undergo Toric-IOL or PCRIs in the steep axis with spherical IOL implantation .


LogMAR uncorrected visual acuity ( LogMAR UCVA ) , LogMAR best corrected visual acuity ( LogMAR BCVA ) , error of vector ( | EV | ) , surgery induced refraction correction ( | SIRC | ) , and correction rates ( CR ) were measured 1 month and 6 months postoperatively .


At 6 months postoperatively , all 54 eyes had LogMAR BCVA 0.2 .


Patients who underwent PCRIs and Toric-IOL with LogMAR BCVA 0.1 showed no significant differences in group A ( P = 1.00 ) or in group B ( P = 0.59 ) .


Group A showed no significant differences in LogMAR UCVA ( P = 0.70 ) , | EV | ( P = 0.13 ) , | SIRC | ( P = 0.71 ) , and CR ( P = 0.56 ) in patients underwent PCRIs and Toric-IOL .


However , group B showed significant differences in LogMAR UCVA ( P < 0.01 ) , | EV | ( P < 0.01 ) ) , | SIRC | ( P < 0.01 ) , and CR ( P < 0.01 ) .


The LogMAR UCVA and | EV | between 1 and 6 months showed no significant differences in patients in group A. However , in group B , they are significant differences .


The efficacy and stability of Toric-IOL and PCRIs were equal in low astigmatic patients .


Toric-IOL achieved an enhanced effect over PCRIs in higher astigmatic patients .


PCRIs had the more refractive regression than Toric-IOL in 6 months .


Inhibition of angiogenesis is a valuable treatment strategy for ovarian cancer .


Pazopanib is an anti-angiogenic drug active in ovarian cancer .


We assessed the effect of adding pazopanib to paclitaxel for patients with platinum-resistant or platinum-refractory advanced ovarian cancer .


We did this open-label , randomised phase 2 trial at 11 hospitals in Italy .


We included patients with platinum-resistant or platinum-refractory ovarian cancer previously treated with a maximum of two lines of chemotherapy , Eastern Cooperative Oncology Group performance status 0-1 , and no residual peripheral neurotoxicity .


Patients were randomly assigned ( 1:1 ) to receive weekly paclitaxel 80 mg/m ( 2 ) with or without pazopanib 800 mg daily , and stratified by centre , number of previous lines of chemotherapy , and platinum-free interval status .


The primary endpoint was progression-free survival , assessed in the modified intention-to-treat population .


This trial is registered with ClinicalTrials.gov , number NCT01644825 .


This report is the final analysis ; the trial is completed .


Between Dec 15 , 2010 , and Feb 8 , 2013 , we enrolled 74 patients : 37 were randomly assigned to receive paclitaxel and pazopanib and 37 were randomly assigned to receive paclitaxel only .


One patient , in the paclitaxel only group , withdrew from the study and was excluded from analyses .


Median follow-up was 161 months ( IQR 125-208 ) .


Progression-free survival was significantly longer in the pazopanib plus paclitaxel group than in the paclitaxel only group ( median 635 months [ 95 % CI 536-1102 ] vs 349 months [ 201-566 ] ; hazard ratio 042 [ 95 % CI 025-069 ] ; p = 00002 ) .


We recorded no unexpected toxic effects or deaths from toxic effects .


Adverse events were more common in the pazopanib and paclitaxel group than in the paclitaxel only group .


The most common grade 3-4 adverse events were neutropenia ( 11 [ 30 % ] in the pazopanib group vs one [ 3 % ] in the paclitaxel group ) , fatigue ( four [ 11 % ] vs two [ 6 % ] ) , leucopenia ( four [ 11 % ] vs one [ 3 % ] ) , hypertension ( three [ 8 % ] vs none [ 0 % ] ) , raised aspartate aminotransferase or alanine aminotransferase ( three [ 8 % ] vs none ) , and anaemia ( two [ 5 % ] vs five [ 14 % ] ) .


One patient in the pazopanib group had ileal perforation .


Our findings suggest that a phase 3 study of the combination of weekly paclitaxel plus pazopanib for patients with platinum-resistant or platinum-refractory advanced ovarian cancer is warranted .


National Cancer Institute of Napoli and GlaxoSmithKline .


Clinical mood disorders often become clinically manifest in the later teenage years and early twenties and can be associated with a poor long-term prognosis .


The primary prevention of these disorders would therefore have great public health value .


Nutritional supplements are a feasible intervention for primary prevention and several epidemiological studies have indicated links between low folate status and depressive symptomatology in the general population .


A randomised , double blind , parallel group , placebo-controlled trial in which participants , aged 14-24 years , at increased familial risk of mood disorder , were randomised to folic acid ( 2.5 mg daily ) or identical placebo liquid for a maximum of 36 months .


Primary outcome data ( the onset of a DSM-IV mood disorder ) were collected from 112 participants ; 56 per group .


The incidence of mood disorder in the folic acid and placebo groups were 14.3 % and 17.9 % respectively , a non-significant difference .


However , there was post-hoc evidence that folic acid delayed the time to onset of mood disorder in those participants who became unwell .


Small sample size and rate of onset of mood disorders lower than expected .


Although long term folic acid supplementation was well tolerated , with high levels of adherence , there was no evidence that it reduced the incidence of mood disorder compared to those taking placebo .


A third of the 25 billion people worldwide without access to improved sanitation live in India , as do two-thirds of the 11 billion practising open defecation and a quarter of the 15 million who die annually from diarrhoeal diseases .


We aimed to assess the effectiveness of a rural sanitation intervention , within the context of the Government of India 's Total Sanitation Campaign , to prevent diarrhoea , soil-transmitted helminth infection , and child malnutrition .


We did a cluster-randomised controlled trial between May 20 , 2010 , and Dec 22 , 2013 , in 100 rural villages in Odisha , India .


Households within villages were eligible if they had a child younger than 4 years or a pregnant woman .


Villages were randomly assigned ( 1:1 ) , with a computer-generated sequence , to undergo latrine promotion and construction or to receive no intervention ( control ) .


Randomisation was stratified by administrative block to ensure an equal number of intervention and control villages in each block .


Masking of participants was not possible because of the nature of the intervention .


However , households were not told explicitly that the purpose of enrolment was to study the effect of a trial intervention , and the surveillance team was different from the intervention team .


The primary endpoint was 7-day prevalence of reported diarrhoea in children younger than 5 years .


We did intention-to-treat and per-protocol analyses .


This trial is registered with ClinicalTrials.gov , number NCT01214785 .


We randomly assigned 50 villages to the intervention group and 50 villages to the control group .


There were 4586 households ( 24,969 individuals ) in intervention villages and 4894 households ( 25,982 individuals ) in control villages .


The intervention increased mean village-level latrine coverage from 9 % of households to 63 % , compared with an increase from 8 % to 12 % in control villages .


Health surveillance data were obtained from 1437 households with children younger than 5 years in the intervention group ( 1919 children younger than 5 years ) , and from 1465 households ( 1916 children younger than 5 years ) in the control group .


7-day prevalence of reported diarrhoea in children younger than 5 years was 88 % in the intervention group and 91 % in the control group ( period prevalence ratio 097 , 95 % CI 083-112 ) .


162 participants died in the intervention group ( 11 children younger than 5 years ) and 151 died in the control group ( 13 children younger than 5 years ) .


Increased latrine coverage is generally believed to be effective for reducing exposure to faecal pathogens and preventing disease ; however , our results show that this outcome can not be assumed .


As efforts to improve sanitation are being undertaken worldwide , approaches should not only meet international coverage targets , but should also be implemented in a way that achieves uptake , reduces exposure , and delivers genuine health gains .


Bill & Melinda Gates Foundation , International Initiative for Impact Evaluation ( 3ie ) , and Department for International Development-backed SHARE Research Consortium at the London School of Hygiene & Tropical Medicine .


To test the effectiveness of an integrated collaborative care model for people with depression and long term physical conditions .


Cluster randomised controlled trial .


36 general practices in the north west of England .


387 patients with a record of diabetes or heart disease , or both , who had depressive symptoms ( 10 on patient health questionaire-9 ( PHQ-9 ) ) for at least two weeks .


Mean age was 58.5 ( SD 11.7 ) .


Participants reported a mean of 6.2 ( SD 3.0 ) long term conditions other than diabetes or heart disease ; 240 ( 62 % ) were men ; 360 ( 90 % ) completed the trial .


Collaborative care included patient preference for behavioural activation , cognitive restructuring , graded exposure , and/or lifestyle advice , management of drug treatment , and prevention of relapse .


Up to eight sessions of psychological treatment were delivered by specially trained psychological wellbeing practitioners employed by Improving Access to Psychological Therapy services in the English National Health Service ; integration of care was enhanced by two treatment sessions delivered jointly with the practice nurse .


Usual care was standard clinical practice provided by general practitioners and practice nurses .


The primary outcome was reduction in symptoms of depression on the self reported symptom checklist-13 depression scale ( SCL-D13 ) at four months after baseline assessment .


Secondary outcomes included anxiety symptoms ( generalised anxiety disorder 7 ) , self management ( health education impact questionnaire ) , disability ( Sheehan disability scale ) , and global quality of life ( WHOQOL-BREF ) .


19 general practices were randomised to collaborative care and 20 to usual care ; three practices withdrew from the trial before patients were recruited .


191 patients were recruited from practices allocated to collaborative care , and 196 from practices allocated to usual care .


After adjustment for baseline depression score , mean depressive scores were 0.23 SCL-D13 points lower ( 95 % confidence interval -0.41 to -0.05 ) in the collaborative care arm , equal to an adjusted standardised effect size of 0.30 .


Patients in the intervention arm also reported being better self managers , rated their care as more patient centred , and were more satisfied with their care .


There were no significant differences between groups in quality of life , disease specific quality of life , self efficacy , disability , and social support .


Collaborative care that incorporates brief low intensity psychological therapy delivered in partnership with practice nurses in primary care can reduce depression and improve self management of chronic disease in people with mental and physical multimorbidity .


The size of the treatment effects were modest and were less than the prespecified effect but were achieved in a trial run in routine settings with a deprived population with high levels of mental and physical multimorbidity .


ISRCTN80309252 .


Intermittent preventive treatment ( IPT ) in schoolchildren offers a promising option for malaria control .


However , the optimal drug and dosing regimens for IPT remain to be determined .


We conducted a randomized , double-blind , placebo-controlled trial in 740 schoolchildren aged 6-14 years living in a setting of high malaria transmission in Uganda .


Enrolled children were randomized to dihydroartemisinin-piperaquine ( DP ) given once a month ( IPTm ) , DP given once a school term ( 4 treatments over 12 months , IPTst ) , or placebo and followed for 12 months .


The primary outcome was the incidence of malaria over 12 months .


Secondary outcomes included parasite prevalence and anemia over 12 months .


Analyses were conducted on an intention-to-treat basis .


In the placebo arm , the incidence of malaria was 0.34 episodes per person-year and the prevalence of parasitemia and anemia was 38 % and 20 % , respectively .


IPTm reduced the incidence of malaria by 96 % ( 95 % confidence interval [ CI ] , 88 % -99 % , P < .0001 ) , the prevalence of asymptomatic parasitemia by 94 % ( 95 % CI , 92 % -96 % , P < .0001 ) , and the prevalence of anemia by 40 % ( 95 % CI , 19 % -56 % , P < .0001 ) .


IPTst had no significant effect on the incidence of symptomatic malaria or the prevalence of anemia , but reduced the prevalence of asymptomatic parasitemia by 54 % ( 95 % CI , 47 % -60 % , P < .0001 ) .


Monthly IPT with DP offered remarkable protection against clinical malaria , parasitemia , and anemia in schoolchildren living in a high-malaria-transmission setting .


NCT01231880 .


Pancreatic cancer is often accompanied by severe abdominal or back pain .


It 's the first study to evaluate the analgesic effect of electroacupuncture on pancreatic cancer pain .


A randomized controlled trial compared electroacupuncture with control acupuncture using the placebo needle .


Sixty patients with pancreatic cancer pain were randomly assigned to the electroacupuncture group ( n = 30 ) and the placebo control group ( n = 30 ) .


Patients were treated on Jiaji ( Ex-B2 ) points T8-T12 bilaterally for 30min once a day for 3 days .


Pain intensity was assessed with numerical rated scales ( NRS ) before the treatment ( Baseline ) , after 3 treatments , and 2 days follow-up .


Baseline characteristics were similar in the two groups .


After 3 treatment , pain intensity on NRS decreased compared with Baseline ( -1.67 , 95 % confidence interval [ CI ] -1.46 to-1 .87 ) in the electroacupuncture group ; there was little change ( -0.13 , 95 % CI 0.08 to-0 .35 ) in control group ; the difference between two groups was statistically significant ( P < 0.001 ) .


Follow-up also found a significant reduction in pain intensity in the electroacupuncture group compared with the control group ( P < 0.001 ) .


Electroacupuncture was an effective treatment for relieving pancreatic cancer pain .


To establish the prevalence of anthelmintic resistance in ovine gastrointestinal nematodes in southern Queensland .


An observational parasitological study using the faecal egg count reduction test .


Sheep farms ( n = 20 ) enrolled in this study met the twin criteria of using worm testing for drench decisions and having concerns about anthelmintic efficacy .


On each farm , 105 sheep were randomly allocated to one of six treatment groups or an untreated control group .


Faecal samples were collected on day 0 and days 10-14 for worm egg counts and larval differentiation .


Single - and multi-combination anthelmintics , persistent and non-persistent , oral liquid or capsule , pour-on and injectable formulations were tested .


Monepantel was not tested .


Farmers also responded to a questionnaire on drenching practices .


Haemonchus contortus was the predominant species .


Efficacy < 95 % was recorded on 85 % of farms for one or more anthelmintics and on 10 % of farms for six anthelmintics .


No resistance was identified on three farms .


The 4-way combination product was efficacious ( n = 4 farms ) .


Napthalophos resistance was detected on one farm only .


Resistance to levamisole ( 42 % of farms ) , moxidectin injection ( 50 % of farms ) and the closantel/abamectin combination ( 67 % of farms ) was identified .


Moxidectin oral was efficacious against Trichostrongylus colubriformis , which was predominant on only one farm .


Of the farms tested , 55 % ran meat breeds , 60 % dosed more than the recommended dose rate and 70 % always , mostly or when possible practised a ` drench and move ' strategy .


This level of anthelmintic resistance in southern Queensland will severely compromise worm control and force increased use of monepantel .


Caudal block ( CB ) has some disadvantages , one of which is its short duration of action after a single injection .


For hypospadias repair , pudendal nerve block ( PNB ) might be a suitable alternative since it has been successfully used for analgesia for circumcision .


We evaluated PNB compared with CB as measured by total analgesic consumption 24 hours postoperatively .


In this prospective , double-blinded study , patients were randomized into 2 groups , either receiving CB or nerve stimulator-guided PNB .


In the PNB group , patients were injected with 0.3 mL/kg 0.25 % bupivacaine and 1 g/kg clonidine .


In the CB group , patients were injected with 1 mL/kg 0.25 % bupivacaine and 1 g/kg clonidine .


Analgesic consumption was assessed during the first 24 hours postoperatively .


The `` objective pain scale '' developed by Hannalah and Broadman was used to assess postoperative pain .


Eighty patients participated in the study , 40 in each group .


The mean age in the PNB group was 3.1 ( 1.1 ) years and in the CB group was 3.2 ( 1.1 ) years .


The mean weights in the PNB and CB groups were 15.3 ( 2.8 ) kg and 15.3 ( 2.2 ) kg , respectively .


The percentage of patients who received analgesics during the first 24 hours were significantly higher in the CB ( 70 % ) compared with the PNB group ( 20 % , P < 0.0001 ) .


The average amount of analgesics consumed per patient within 24 hours postoperatively was higher in the CB group ( paracetamol P < 0.0001 , Tramal P = 0.003 ) .


Patients who received PNB had reduced analgesic consumption and pain within the first 24 hours postoperatively compared with CB .


Human papillomavirus ( HPV ) self-sampling ( Self-HPV ) may be used as a primary cervical cancer screening method in a low resource setting .


Our aim was to evaluate whether an educational intervention would improve women 's knowledge and confidence in the Self-HPV method .


Women aged between 25 and 65 years old , eligible for cervical cancer screening , were randomly chosen to receive standard information ( control group ) or standard information followed by educational intervention ( interventional group ) .


Standard information included explanations about what the test detects ( HPV ) , the link between HPV and cervical cancer and how to perform HPV self-sampling .


The educational intervention consisted of a culturally tailored video about HPV , cervical cancer , Self-HPV and its relevancy as a screening test .


All participants completed a questionnaire that assessed sociodemographic data , women 's knowledge about cervical cancer and acceptability of Self-HPV .


A total of 302 women were enrolled in 4 health care centers in Yaound and the surrounding countryside .


301 women ( 149 in the `` control group '' and 152 in the `` intervention group '' ) completed the full process and were included into the analysis .


Participants who received the educational intervention had a significantly higher knowledge about HPV and cervical cancer than the control group ( p < 0.05 ) , but no significant difference on Self-HPV acceptability and confidence in the method was noticed between the two groups .


Educational intervention promotes an increase in knowledge about HPV and cervical cancer .


Further investigation should be conducted to determine if this intervention can be sustained beyond the short term and influences screening behavior .


International Standard Randomised Controlled Trial Number ( ISRCTN ) Register ISRCTN78123709 .


The benefits of combined systemic and liver-directed treatments in inoperable intermediate - or advanced-stage hepatocellular carcinoma ( HCC ) have yet to be defined .


This article presents the planned safety analyses for the first 40 patients randomized to radioembolization with yttrium-90 ( ( 90 ) Y ) resin microspheres followed by sorafenib ( n = 20 ) or sorafenib only ( n = 20 ) in the SORAMIC study .


Patients identified for palliative treatment who were poor candidates for transarterial ( chemo ) embolization ( including those failing TACE ) with preserved liver function ( Child-Pugh B7 ) and ECOG performance status < 2 were screened .


Radioembolization was administered using a sequential lobar approach .


On day 3 after the last radioembolization procedure , sorafenib 200 mg twice daily was initiated escalating to 400 mg twice daily 1 week later ; a matching sorafenib dose schedule was initiated in the control arm .


Patients were followed up for a median of 8.3 months .


Median total implanted activity of ( 90 ) Y was 1.87 ( range : 0.54-2 .35 ) GBq .


Patients received a similar intensity and duration of sorafenib in the combination-treatment arm ( median daily dose 614 mg over 8.5 months ) and control arm ( 557 mg over 9.6 months ) .


The incidence of total ( 196 vs. 222 ) and grade 3 ( 43 vs. 47 ) adverse events was similar in combination-treatment arm and control arm respectively ( P > 0.05 ) .


No significant differences in the number of total or grade 3/4 toxicities were recorded for : total bilirubin , albumin , liver enzymes , ascites , Child-Pugh , fatigue , hand-foot skin reaction , blood pressure or diarrhoea .


Radioembolization followed by sorafenib appears to be as well tolerated as sorafenib alone .


Subcutaneous drainage is considered effective for preventing wound infections , but only anecdotal evidence supports its clinical benefit .


The present study evaluated the benefit of subcutaneous drainage in preventing wound infections in patients undergoing liver resection .


Patients scheduled for liver resection were randomly assigned to receive or not receive subcutaneous drains .


After suture of the peritoneum and fascia , a 10 Fr drain was placed subcutaneously and connected to a low pressure ( under 80cmH2 O ) aspiration reservoir to allow drainage of the full length of the wound .


The primary endpoint was wound infection development within 30 days of the liver resection .


We performed liver resections in 260 patients with hepatobiliary malignancies .


Between the subcutaneous-drainage group ( n = 131 ) and non-drainage group ( n = 129 ) , there were no significant differences in the operative variables .


Wound infection occurred in 10 drainage group patients ( 8 % ) and 12 patients ( 9 % ) in the non-drainage group ( P = 0.629 ) ; there was no significant difference in the probability of wound infection ( P = 0.624 ) .


No significant differences were found between the groups for the hospital stay duration ( P = 0.363 ) , postoperative complications ( P = 0.725 ) or medical expenses ( P = 0.360 ) .


Subcutaneous drainage does not prevent wound infections in patients undergoing liver resection ; therefore , its routine use is not justified .


While portable , supplemental oxygen is often necessary for patients with chronic obstructive pulmonary disease ( COPD ) to retain independence , it may provide functional limitations because of the increased workload imposed .


This issue may result in nonuse , creating a need to identify carrying modalities that optimize transport .


This study assessed the effects of 3 methods of portable oxygen transport on 6-minute walk distance ( 6 MWD ) , rate of perceived exertion ( RPE ) , heart rate ( HR ) , and oxyhemoglobin saturation ( SpO2 ) .


As weight status is known to impact functional ability in COPD , effects of body mass index ( BMI ) were also assessed .


Data were analyzed using the mixed-model procedure to test for effects of transport modality ( reference , rolling cart , backpack , shoulderstrap ) , time ( minutes 1-6 ) , BMI , non-overweight , overweight , and interactions of these variables on outcome parameters .


A main effect of condition was found for 6 MWD , and an interaction of condition BMI was found for HR and RPE , and of time BMI for 6 MWD and SpO2 .


Participants walked the least distance in rolling cart condition , which was also characterized by the greatest RPE .


For the overweight group , HR was least in the reference compared with other conditions ; but for the non-overweight group , the opposite pattern was observed .


At latter time points , 6 MWD was greater in the non-overweight group , while SpO2 was reduced .


Results demonstrate that transport modality of portable oxygen exerts differential effects on functional performance in COPD patients and that BMI may moderate underlying physiologic factors that contribute to performance outcomes .


An increasing body of evidence is being published about single-incision laparoscopic cholecystectomy ( SILC ) , but there are no well-powered trials with an adequate evaluation of post-operative pain .


This randomized trial compares SILC against four-port laparoscopic cholecystectomy ( LC ) with post-operative pain as the primary endpoint .


Hundred patients were randomized to either SILC ( n = 50 ) or LC ( n = 50 ) .


Exclusion criteria were ( 1 ) Acute cholecystitis ; ( 2 ) ASA 3 or above ; ( 3 ) Bleeding disorders ; and ( 4 ) Previous open upper abdominal surgery .


Patients and post-operative assessors were blinded to the procedure performed .


The site and severity of pain were compared at 4 h , 24 h , 14 days and 6 months post-procedure using the visual analog scale ; non-inferiority was assumed when the lower boundary of the 95 % confidence interval of the difference was above -1 and superiority when p 0.05 .


The study arms were demographically similar .


At 24 h post-procedure , SILC was associated with less pain at extra-umbilical sites ( rest : p = 0.004 ; movement : p = 0.008 ) .


Pain data were inconclusive at 24 h at the umbilical site on movement ; SILC was otherwise non-inferior for pain at all other points .


Operating duration was longer in SILC ( 79.46 vs 58.88 min , p = 0.003 ) .


8 % of patients in each arm suffered complications ( p = 1.000 ) .


Re-intervention rates , analgesic use , return to function , and patient satisfaction did not differ significantly .


SILC has improved short-term pain outcomes compared to LC and is not inferior in both short-term and long-term pain outcomes .


The operating time is longer , but remains feasible in routine surgical practice .


In COPD , the long-acting bronchodilators are not always able to provide an appropriate bronchodilator effect in terms of amplitude and duration and this can result in increased severity of respiratory symptoms and in worsening of health status .


Combined long-acting bronchodilators can address this limitation .


Analysis of a recent study evaluating the efficacy and safety of 26 weeks of therapy with glycopyrronium + indacaterol single inhaler ( QVA149 ) versus each component , versus tiotropium and versus placebo .


Such a combination can provide a superior and sustained bronchodilator effect and can minimize the respiratory symptoms resulting from a suboptimally inhibited bronchoconstriction .


Docetaxel plus prednisone is a standard treatment for castration-resistant prostate cancer .


Cyclophosphamide may be an effective combination partner .


This randomised , multicentre , phase II trial compared the combination therapy of docetaxel plus prednisone plus cyclophosphamide with the standard therapy of docetaxel plus prednisone .


Thirty-three patients received six 3-week treatment cycles ( in total 171 cycles ) .


During treatment , an adequate decline in prostate-specific antigen was seen in both groups ( p = 0.068 ) without between-group differences ( p = 0.683 ) .


No relevant differences between within-group changes were observed for blood pressure , weight , pain score , laboratory variables or quality of life .


There were no serious side effects apart from leucopenia requiring treatment ( docetaxel + prednisone + cyclophosphamide arm ) and no drug-related withdrawals ; all three fatalities were considered to be cancer related .


The oncological effectiveness and tolerability of docetaxel plus prednisone were supported ; an additional effect of cyclophosphamide was not detected .


However , the small number of patients and short observation period restrict the generalisability of the results .


This study aimed to compare continuous and pulsed ultrasound therapy with sham ultrasound in terms of pain , severity of muscle spasm , function , depression , and quality of life in patients with myofascial pain syndrome .


Patients were randomly divided into three groups , including the continuous ultrasound group ( 3 MHz , 1 W/cm , n = 20 ) , the pulsed ultrasound group ( 3 MHz , 1 W/cm , 1:1 ratio , n = 20 ) , and control group ( sham , n = 20 ) .


The primary outcome measures were severity of pain at rest and during activity ( visual analog scale , 0-10 cm ) .


The secondary outcome measures were function ( Neck Pain and Disability Scale ) , depressive mood ( Beck Depression Scale ) , and quality of life ( Nottingham Health Profile ) .


All evaluations were performed at baseline , after treatment , and at the 6th and 12th wks .


All three groups had significant improvements in all of the pain scores , the severity of muscle spasms , function assessments , and certain subparameters of the quality of life scale ( P < 0.05 ) .


The continuous ultrasound group had significantly greater improvements in pain at rest ( P < 0.05 ) .


However , no statistically significant differences were observed in the other parameters ( P > 0.05 ) .


Continuous ultrasound therapy is more efficient in reducing pain at rest for myofascial pain syndrome patients than is sham or pulsed ultrasound therapy .


There is little systematic research on the efficacy and tolerability of the addition of adjunctive analgesic agents in paravertebral analgesia .


The addition of adjunctive analgesics , such as fentanyl and clonidine , to local anesthetics has been shown to enhance the quality and duration of sensory neural blockades , and decrease the dose of local anesthetic and supplemental analgesia .


Investigation of the safety and the analgesic efficacy of adding 1 g/kg dexmedetomidine to bupivacaine 0.25 % in thoracic paravertebral blocks ( PVB ) in patients undergoing modified radical mastectomy .


A randomized , double-blind trial .


Academic medical center .


Sixty American Society of Anesthesiologists physical status - I - III patients were randomly assigned to receive thoracicPVB with either 20 mL of bupivacaine 0.25 % ( Group B , n = 30 ) , or 20 mL of bupivacaine 0.25 % + 1 g/kg dexmedetomidine ( Group BD , n = 30 ) .


Assessment parameters included hemodynamics , sedation score , pain severity , time of first analgesics request , total analgesic consumption , and side effects in the first 48 hours .


There was a significant reduction in pulse rate and diastolic blood pressure starting at 30 minutes in both groups , but more evidenced in group BD ( P < 0.001 ) .


Intraoperative Systolic blood pressure showed a significant reduction at 30 minutes in both groups ( P < 0.001 ) then returned to baseline level at 120 minutes in both groups .


There was a significant increase in pulse rate starting 2 hours postoperative until 48 hours postoperatively in group B but only after 12 hours until 48 hours in group BD ( P < 0.001 ) .


The time of the first rescue analgesic requirement was significantly prolonged in the group BD ( 8.16 42 hours ) in comparison to group B ( 6.48 5.24 hours ) ( P = 0.04 ) .


The mean total consumption of intravenous tramadol rescue analgesia in the postanesthesia care unit in the firtst 48 hours postoperatively was significantly decreased in group BD ( 150.19 76.98 mg ) compared to group B ( 194.44 63.91 mg ) ( P = 0.03 ) .


No significant serious adverse effects were recorded during the study .


This study is limited by its sample size .


The addition of dexmedetomidine 1 g/kg to bupivacaine 0.25 % in thoracic PVB in patients undergoing modified radical mastectomy improves the quality and the duration of analgesia and also provides an analgesic sparing effect with no serious side effects .


Regular exercise has been proposed as a potential smoking cessation aid .


This study aimed to determine the effects of an exercise counseling program on cigarette smoking abstinence at 24weeks .


A parallel , two-arm , randomized controlled trial was conducted .


Adult cigarette smokers ( n = 906 ) who were insufficiently active and interested in quitting were randomized to receive the Fit2Quit intervention ( 10 exercise telephone counseling sessions over 6months ) plus usual care ( behavioral counseling and nicotine replacement therapy ) or usual care alone .


There were no significant group differences in 7-day point-prevalence and continuous abstinence at 6months .


The more intervention calls successfully delivered , the lower the probability of smoking ( OR , 0.88 ; 95 % CI 0.81-0 .97 , p = 0.01 ) in the intervention group .


A significant difference was observed for leisure time physical activity ( difference = 219.11 MET-minutes/week ; 95 % CI 52.65-385 .58 ; p = 0.01 ) .


Telephone-delivered exercise counseling may not be sufficient to improve smoking abstinence rates over and above existing smoking cessation services .


( Australasian Clinical Trials Registry Number : ACTRN12609000637246 . )


The aim of this randomized , double-blinded , prospective study was to determine the effectiveness and side effects of intravenous or epidural use of morphine , bupivacaine or ropivacaine on post-thoracotomy pain management .


Sixty patients undergoing elective thoracotomy procedure were randomly allocated into 4 groups by the sealed envelope technique .


Group IVM , EM , EMB and EMR received patient controlled intravenous morphine , and epidural morphine , morphine-bupivacaine and morphine-ropivacaine , respectively .


Perioperative heart rate , blood pressure and oxygen saturation and postoperative pain at rest and during cough , side effects and rescue analgesic requirements were recorded at the 30 ( th ) and 60 ( th ) minutes and the 2 ( nd ) , 4 ( th ) , 6 ( th ) , 12 ( th ) , 24 ( th ) , 36 ( th ) , 48 ( th ) , and 72 ( nd ) hour .


Diclofenac sodium requirement during the study was lower in Group EM .


Area under VAS-time curve was lower in Group EM compared to Group IVM , but similar to Group EMB and EMR .


Pain scores at rest were higher at the 12 , 24 , 36 , and 48 ( th ) hour in Group IVM compared to Group EM .


Pain scores at rest were higher at the 30 ( th ) and 60 ( th ) minutes in Group EM and Group IVM compared to Group EMB .


Pain scores during cough at the 30 ( th ) minute were higher in Group EM compared to Group EMB .


There was no difference between Group IVM and Group EMR .


Morphine used at the epidural route was found more effective than the intravenous route .


While Group EM was more effective in the late period of postoperative , Group EMB was more effective in the early period .


We concluded that epidural morphine was the most effective and preferred one .


Daclatasvir-containing regimens have the potential to address limitations of current regimens combining peginterferon alfa and ribavirin with first-generation protease inhibitors for treatment of chronic HCV genotype 1 infection .


In this randomized , double-blind study , 27 Japanese treatment-naive patients received once-daily daclatasvir 10 mg or 60 mg or placebo , each combined with peginterferon alfa-2b / ribavirin ; 18 prior null ( n = 9 ) or partial ( n = 9 ) responders received the same daclatasvir-containing regimens without a placebo arm .


Daclatasvir recipients with protocol-defined response ( HCV RNA < 15 IU/ml at week 4 , undetectable at week 12 ) were treated for 24 weeks ; those without protocol-defined response and placebo recipients continued treatment to week 48 .


Sustained virological response 24 weeks post-treatment ( SVR24 ) was achieved by 66.7 % , 90.0 % and 62.5 % of treatment-naive patients in the daclatasvir 10 mg , 60 mg and placebo groups , respectively .


Prior non-responders had more frequent virological failure ; 22.2 % and 33.3 % of daclatasvir 10 mg and 60 mg recipients , respectively , achieved SVR24 .


Adverse events were similar across groups and were typical of peginterferon alfa-2b / ribavirin .


Pyrexia , headache , alopecia , decreased appetite and malaise were the most common adverse events ; two daclatasvir recipients discontinued due to adverse events .


Daclatasvir 60 mg combined with peginterferon alfa-2b and ribavirin achieved a high rate of SVR24 in treatment-naive patients with HCV genotype 1 infection , with tolerability similar to that of peginterferon alfa-2b / ribavirin alone .


However , regimens with greater antiviral potency are needed for prior non-responders .


Traumatic brain injury ( TBI ) is commonly accompanied by intracranial bleeding which can worsen after hospital admission .


Tranexamic acid ( TXA ) has been shown to reduce bleeding in elective surgery and there is evidence that short courses of TXA can reduce rebleeding in spontaneous intracranial haemorrhage .


We aimed to determine the effectiveness and safety of TXA in preventing progressive intracranial haemorrhage in TBI .


This is a double blinded , placebo controlled randomized trial .


We enrolled 238 patients older than 16years with moderate to severe TBI ( post-resuscitation Glasgow Coma Scale ( GCS ) 4 to 12 ) who had a computerized tomography ( CT ) brain scan within eight hours of injury and in whom there was no immediate indication for surgery .


We excluded patients if they had a coagulopathy or a serum creatinine over than 2.0 milligrams % .


The treatment was a single dose of 2 grams of TXA in addition to other standard treatments .


The primary outcome was progressive intracranial haemorrhage ( PIH ) which was defined as an intracranial haemorrhage seen on the second CT scan that was not seen on the first CT scan , or an intracranial haemorrhage seen on the first scan that had expanded by 25 % or more on any dimension ( height , length , or width ) on the second scan .


Progressive intracranial haemorrhage was present in 21 ( 18 % ) of 120 patients allocated to TXA and in 32 ( 27 % ) of 118 patients allocated to placebo .


The difference was not statistically significant [ RR = 0.65 ( 95 % CI 0.40 to 1.05 ) ] .


There were no significant difference in the risk of death from all causes in patients allocated to TXA compared with placebo [ RR = 0.69 ( 95 % CI 0.35 to 1.39 ) ] and the risk of unfavourable outcome on the Glasgow Outcome Scale [ RR = 0.76 ( 95 % CI 0.46 to 1.27 ) ] .


There was no evidence of increased risk of thromboembolic events in those patients allocated to TXA .


TXA may reduce PIH in patients with TBI ; however , the difference was not statistically significant in this trial .


Large clinical trials are needed to confirm and to assess the effect of TXA on death or disability after TBI .


The aims of this study were to adapt a traditional recipe into a healthier form by adding 3 g of oat - glucan , substituting milk chocolate to dark chocolate with 70 % cocoa , and to examine the effect of these alterations on short-term satiety and energy intake .


Study subjects ( n = 25 ) were tested in a randomized , crossover design with four products closely matched for energy content .


Four different versions of a traditional recipe including milk chocolate-control ( CON ) , oat - glucan ( B-GLU ) , dark chocolate ( DARK ) or oat - glucan and dark chocolate ( B-GLU + DARK ) were given to subjects on different test days .


After subjects were asked to report visual analog scale ( VAS ) scores on sensory outcomes and related satiety for four hours ad libitum , lunch was served and energy intake of individuals was measured .


VAS scores indicated that none of the test foods exerted an improved effect on satiety feelings .


However , energy intake of individuals during ad libitum lunch was significantly lower in dark chocolate groups ( CON : 849.46 47.45 kcal versus DARK : 677.69 48.45 kcal and B-GLU + DARK : 691.08 47.45 kcal , p = 0.014 ) .


The study demonstrated that substituting dark chocolate for milk chocolate is more effective in inducing satiety during subsequent food intake in healthy subjects .


In recent years , the U.S. has experienced a significant increase in the prevalence of pregnant opioid-dependent women and of neonatal abstinence syndrome ( NAS ) , which is caused by withdrawal from in-utero drug exposure .


While methadone-maintenance currently is the standard of care for opioid dependence during pregnancy , research suggests that buprenorphine-maintenance may be associated with shorter infant hospital lengths of stay ( LOS ) relative to methadone-maintenance .


There is no `` gold standard '' treatment for NAS but there is evidence that buprenorphine , relative to morphine or methadone , treatment may reduce LOS and length of treatment .


Point-of-care clinical trial ( POCCT ) designs , maximizing external validity while reducing cost and complexity associated with classic randomized clinical trials , were selected for two planned trials to compare methadone to buprenorphine treatment for opioid dependence during pregnancy and for NAS .


This paper describes design considerations for the Medication-assisted treatment for Opioid-dependent expecting Mothers ( MOMs ; estimated N = 370 ) and Investigation of Narcotics for Ameliorating Neonatal abstinence syndrome on Time in hospital ( INFANTs ; estimated N = 284 ) POCCTs , both of which are randomized , intent-to-treat , two-group trials .


Outcomes would be obtained from participants ' electronic health record at three participating hospitals .


Additionally , a subset of infants in the INFANTs POCCT would be from mothers in the MOMs POCCT and , thus , potential interaction between medication treatment of mother and infant could be evaluated .


This pair of planned POCCTs would evaluate the comparative effectiveness of treatments for opioid dependence during pregnancy and for NAS .


The results could have a significant impact on practice .


Uptake of human papillomavirus ( HPV ) vaccinations by 17 - to 18-year-old girls in England is below ( < 35 % ) target ( 80 % ) .


This trial assesses ( a ) the impact of financial incentives on uptake and completion of an HPV vaccination program , and ( b ) whether impacts are moderated by participants ' deprivation level .


It also assesses the impact of incentives on decision quality to get vaccinated , as measured by attitudes toward the vaccination and knowledge of its consequences .


One thousand 16 - to 18-year-old girls were invited to participate in an HPV vaccination program : 500 previously uninvited , and 500 unresponsive to previous invitations .


Girls randomly received either a standard invitation letter or a letter including the offer of vouchers worth 45 ( 56 ; $ 73 ) for undergoing 3 vaccinations .


Girls attending their first vaccination appointment completed a questionnaire assessing decision quality to be vaccinated .


Outcomes were uptake of the first and third vaccinations and decision quality .


The intervention increased uptake of the first ( first-time invitees : 28.4 % vs. 19.6 % , odds ratio [ OR ] = 1.63 , 95 % confidence interval [ CI ; 1.08 , 2.47 ] ; previous nonattenders : 23.6 % vs. 10.4 % , OR = 2.65 , 95 % CI [ 1.61 , 4.38 ] ) and third ( first-time invitees : 22.4 % vs. 12 % , OR = 2.15 , 95 % CI [ 1.32 , 3.50 ] ; previous nonattenders : 12.4 % vs. 3 % , OR = 4.28 , 95 % CI [ 1.92 , 9.55 ] ) vaccinations .


Impacts were not moderated by deprivation level .


Decision quality was unaffected by the intervention .


Although the intervention increased completion of HPV vaccinations , uptake remained lower than the national target , which , in addition to cost effectiveness and acceptability issues , necessitates consideration of other ways of achieving it .


To test whether subconjunctival cyclosporine A ( CsA ) implants affect the incidence and the degree of corneal neovascularization occurring after penetrating keratoplasty .