Effects of single dose intranasal oxytocin on social cognition in schizophrenia . Deficits in social cognition are common in schizophrenia and predict poor community functioning . Given the current limitations of psychosocial treatments and the lack of pharmacological treatments for social cognitive deficits , the development of novel therapeutic agents could greatly enhance functional recovery in schizophrenia . This study evaluated whether a single dose of intranasal oxytocin acutely improves social cognitive functioning in schizophrenia . Twenty-three male veterans with schizophrenia completed baseline assessments of social cognition that were divided into lower-level ( facial affect perception , social perception , detection of lies ) and higher-level ( detection of sarcasm and deception , empathy ) processes . One week later , patients received the same battery after being randomized to a single dose of 40 IU intranasal oxytocin or placebo . Though the groups did not differ significantly on the social cognition composite score , oxytocin improved performance for the higher-level social cognitive tasks ( Cohen 's d=1.0 , p=0.045 ) . Subjects were unable to accurately guess which treatment they had received . The improvements found in higher-level social cognition encourage further studies into the therapeutic potential of oxytocin in schizophrenia .

oxytocin

oxytocin

intranasal oxytocin

placebo

social cognition

facial affect perception

social perception

detection of lies

detection of sarcasm and deception

empathy

social cognition composite score

higher-level social cognition

schizophrenia

schizophrenia

Twenty-three

male

schizophrenia

schizophrenia


Supporting families in challenging contexts : the CAPEDP project . Although France has one of the most generous health and social care systems for infant and maternal well-being in the Western world , professionals have been increasingly concerned by the rising number of children being referred for mental health problems . The present article describes the first home-visiting program in France to specifically target mental health questions in families living in vulnerable contexts . The CAPEDP project , involving 440 women and their families , took place in Paris and its inner suburbs from 2006 to 2011 . To be eligible for inclusion , women had to be ( i ) under 26 years old , ( ii ) less that 27 weeks pregnant , ( iii ) sufficiently fluent in French to give truly informed consent to participate in the study and benefit from the intervention and ( iv ) presenting with one or more of the following social vulnerability factors : low income , low educational level , and/or intending to bring up the child without the child 's father . The intervention consisted of 44 home visits from the third trimester of pregnancy through to the child 's second birthday . The aim of the intervention was to promote infant mental health and reduce the incidence of infant mental health problems at the age of two years . The intervention paid particular attention to postnatal maternal depression and promoting parenting skills and attachment security , particularly through the use of video during home-visits . A major issue was that of adapting international best practice recommendations with regard to home-visiting programs to the particularities of the existing French social and health care system . An original aspect of the intervention was to use trained clinical psychologists to conduct all home visits .

home-visiting program

use of video during home-visits

infant mental health


Pregnancy outcome and glycemic control in women with type 1 diabetes : a retrospective comparison between CSII and MDI treatment . AIM Present study was aimed to evaluate glycemic control and maternal-fetal outcome in pregnant type 1 diabetic patient treated with continuous subcutaneous insulin infusion ( CSII ) or multiple daily injections of insulin ( MDI ) . PATIENTS AND METHODS A retrospective observational study included thirty-four pregnant type 1 diabetic patients . Patients were divided into two group , CSII treated group ( n=14 ) and MDI treated group ( n=20 ) . The HbA1c level and maternal-fetal outcome were evaluated in both the treatment group . Outcome parameters such as glycemic control ( HbA1c ) , hypoglycemic events , time and mode of delivery and labor results ( abortion , premature labor , perinatal mortality , neonatal weight , Apgar score , neonatal hypoglycaemia , presence of congenital abnormalities ) were analyzed . RESULTS Pregnancy outcome and glycemic control in pregnant type 1 diabetic patients treated with CSII and MDI were evaluated and compared . Two groups were compared for their epidemiological parameters , although patients on CSII treatment had longer duration of diabetes compared to MDI treated group . Reduction in HbA1c level was higher in CSII treated patients at first ( CSII : 0.9 % vs MDI : 0.46 % ) , second ( CSII : 1.58 % vs MDI : 0.78 % ) and third trimester ( CSII : 1.74 % vs MDI : 1.09 % ) of pregnancy compared to MDI treated patients . Duration of pregnancy and new born baby weight were founded similar in both group . Moreover , the rate of abortion , preterm labor , cesarean section and hypoglycemia in new born were founded less in CSII treated group compared to MDI treated group and Apgar score was significantly ( p < 0.05 ) higher in CSII treated group compared to MDI treated group . CONCLUSION Results of present study revealed that the CSII gives better glycemic control and pregnancy outcome in pregnant type 1 diabetic patients compared to MDI treatment . CSII also decreases the daily insulin requirement compared MDI .

CSII

MDI

CSII

MDI

glycemic control

glycemic control ( HbA1c

hypoglycemic events

Pregnancy outcome and glycemic control

longer duration of diabetes

Reduction in HbA1c level

Apgar score

women

type 1 diabetes

in pregnant type 1 diabetic patient

thirty-four

pregnant type 1 diabetic patients

pregnant type 1 diabetic


Environmental enrichment as an effective treatment for autism : a randomized controlled trial . Enriched sensorimotor environments enable rodents to compensate for a wide range of neurological challenges , including those induced in animal models of autism . Given the sensorimotor deficits in most children with autism , we attempted to translate that approach to their treatment . In a randomized controlled trial , 3-12 year-old children with autism were assigned to either a sensorimotor enrichment group , which received daily olfactory/tactile stimulation along with exercises that stimulated other paired sensory modalities , or to a control group . We administered tests of cognitive performance and autism severity to both groups at the initiation of the study and after 6 months . Severity of autism , as assessed with the Childhood Autism Rating Scale , improved significantly in the enriched group compared to controls . Indeed , 42 % of the enriched group and only 7 % of the control group had what we considered to be a clinically significant improvement of 5 points on that scale . Sensorimotor enrichment also produced a clear improvement in cognition , as determined by their Leiter-R Visualization and Reasoning scores . At 6 months , the change in average scores for the enriched group was 11.3 points higher than that for the control group . Finally , 69 % of parents in the enriched group and 31 % of parents in the control group reported improvement in their child over the 6-month study . Environmental enrichment therefore appears to be effective in ameliorating some of the symptoms of autism in children .

sensorimotor enrichment group

olfactory/tactile stimulation

control group

autism

Severity of autism

Childhood Autism Rating Scale

clear improvement in cognition

autism

3-12 year-old children

autism


The Pain Course : a randomised controlled trial of a clinician-guided Internet-delivered cognitive behaviour therapy program for managing chronic pain and emotional well-being . The present study evaluated the efficacy of a clinician-guided Internet-delivered cognitive behaviour therapy ( iCBT ) program , the Pain Course , to reduce disability , anxiety , and depression associated with chronic pain . Sixty-three adults with chronic pain were randomised to either a Treatment Group or waitlist Control Group . Treatment consisted of 5 iCBT-based lessons , homework tasks , additional resources , weekly e-mail or telephone contact from a Clinical Psychologist , and automated e-mails . Twenty-nine of 31 Treatment Group participants completed the 5 lessons during the 8-week program , and posttreatment and 3-month follow-up data were collected from 30/31 and 29/31 participants , respectively . Treatment Group participants obtained significantly greater improvements than Control Group participants in levels of disability , anxiety , depression , and average pain levels at posttreatment . These improvements corresponded to small to large between-groups effect sizes ( Cohen 's d ) at posttreatment for disability ( d = .88 ) , anxiety ( d = .38 ) , depression ( d = .66 ) , and average pain ( d = .64 ) , respectively . These outcomes were sustained at follow-up and participants rated the program as highly acceptable . Overall , the clinician spent a total mean time of 81.54 minutes ( SD 30.91 minutes ) contacting participants during the program . The results appear better than those reported in iCBT studies to date and provide support for the potential of clinician-guided iCBT in the treatment of disability , anxiety , and depression for people with chronic pain .

Pain Course

5 iCBT-based lessons

homework tasks

additional resources

automated e-mails

Treatment Group

Control Group

clinician-guided iCBT

disability

anxiety

depression

average pain levels

disability

anxiety

depression

average pain

total mean time

disability

anxiety

depression


Effects of exposure to thin-ideal media images on body dissatisfaction : testing the inclusion of a disclaimer versus warning label . The current study was designed to determine whether the inclusion of a disclaimer ( i.e. , " Retouched photograph aimed at changing a person 's physical appearance . " ) or warning ( i.e. , " Warning : Trying to look as thin as this model may be dangerous to your health . " ) added to images of thin/attractive models would affect body dissatisfaction and intent to diet in female undergraduate students ( n=342 ) . Participants were randomly assigned to one of four groups : ( a ) disclaimer , ( b ) warning , ( c ) model control , or ( d ) car control . Results revealed a significant interaction between group and time , whereby only the car control group reported a significant change ( i.e. , decrease ) in body dissatisfaction over time . Groups did not differ on intent to diet measured at post-exposure . The results largely replicate other findings in this area and call into question advocacy efforts to label media images as a strategy to decrease women 's identification with the stimuli .

disclaimer

warning label

disclaimer

warning

model control

car control

body dissatisfaction

body dissatisfaction

body dissatisfaction

diet


Methylphenidate and/or a nursing telephone intervention for fatigue in patients with advanced cancer : a randomized , placebo-controlled , phase II trial . PURPOSE Cancer-related-fatigue ( CRF ) is common in advanced cancer . The primary objective of the study was to compare the effects of methylphenidate ( MP ) with those of placebo ( PL ) on CRF as measured using the Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F ) fatigue subscale . The effect of a combined intervention including MP plus a nursing telephone intervention ( NTI ) was also assessed . PATIENTS AND METHODS Patients with advanced cancer with a fatigue score of ≥ 4 out of 10 on the Edmonton Symptom Assessment Scale ( ESAS ) were randomly assigned to one of the following four groups : MP+NTI , PL+NTI , MP + control telephone intervention ( CTI ) , and PL+CTI . Methylphenidate dose was 5 mg every 2 hours as needed up to 20 mg per day . The primary end point was the median difference in FACIT-F fatigue at day 15 . Secondary outcomes included anxiety , depression , and sleep . RESULTS One hundred forty-one patients were evaluable . Median FACIT-F fatigue scores improved from baseline to day 15 in all groups : MP+NTI ( median score , 4.5 ; P = .005 ) , PL+NTI ( median score , 8.0 ; P < .001 ) , MP+CTI ( median score , 7.0 ; P = .004 ) , and PL+CTI ( median score , 5.0 ; P = .03 ) . However , there were no significant differences in the median improvement in FACIT-F fatigue between the MP and PL groups ( 5.5 v 6.0 , respectively ; P = .69 ) and among all four groups ( P = .16 ) . Fatigue ( P < .001 ) , nausea ( P = .01 ) , depression ( P = .02 ) , anxiety ( P = .01 ) , drowsiness ( P < .001 ) , appetite ( P = .009 ) , sleep ( P < .001 ) , and feeling of well-being ( P < .001 ) , as measured by the ESAS , significantly improved in patients who received NTI . Grade ≥ 3 adverse events did not differ between MP and PL ( 40 of 93 patients v 29 of 97 patients , respectively ; P = .06 ) . CONCLUSION MP and NTI alone or combined were not superior to placebo in improving CRF .

Methylphenidate

nursing telephone intervention

placebo-controlled

methylphenidate ( MP )

placebo

nursing telephone intervention ( NTI )

fatigue

Cancer-related-fatigue ( CRF )

patients with advanced cancer :

advanced cancer .


The aging motor system as a model for plastic changes of GABA-mediated intracortical inhibition and their behavioral relevance . Since GABAA-mediated intracortical inhibition has been shown to underlie plastic changes throughout the lifespan from development to aging , here , the aging motor system was used as a model to analyze the interdependence of plastic alterations within the inhibitory motorcortical network and level of behavioral performance . Double-pulse transcranial magnetic stimulation ( dpTMS ) was used to examine inhibition by means of short-interval intracortical inhibition ( SICI ) of the contralateral primary motor cortex in a sample of 64 healthy right-handed human subjects covering a wide range of the adult lifespan ( age range 20-88 years , mean 47.6 ± 20.7 , 34 female ) . SICI was evaluated during resting state and in an event-related condition during movement preparation in a visually triggered simple reaction time task . In a subgroup ( N = 23 ) , manual motor performance was tested with tasks of graded dexterous demand . Weak resting-state inhibition was associated with an overall lower manual motor performance . Better event-related modulation of inhibition correlated with better performance in more demanding tasks , in which fast alternating activation of cortical representations are necessary . Declining resting-state inhibition was associated with weakened event-related modulation of inhibition . Therefore , reduced resting-state inhibition might lead to a subsequent loss of modulatory capacity , possibly reflecting malfunctioning precision in GABAAergic neurotransmission ; the consequence is an inevitable decline in motor function .

SICI

manual motor performance

Weak resting-state inhibition

Declining resting-state inhibition

reduced resting-state


[ Efficacy observation on chronic tension-type headache treated with acupuncture at galea tendon-muscle node ] . OBJECTIVE To explore the better therapy for chronic tension-type headache ( CTTH ) . METHODS Two hundred and eighty-eight cases were randomized into a sticking needling group ( 150 cases ) and an acupuncture group ( 138 cases ) . In the sticking needling group , the manual sticking needling technique was adopted to stimulate the galea tendon-muscle node . In the acupuncture group , the conventional acupuncture therapy was applied to Baihui ( GV 20 ) , Sishencong ( EX-HN 1 ) , Fengchi ( GB 20 ) , Taiyang ( EX-HN 5 ) , Touwei ( ST 18 ) , Hegu ( LI 4 ) , etc . The treatment was given once a day , and 30 days made one session . After two sessions of treatment and after three months follow-up , CTTH score ( including the score of headache attack frequency and the score of headache severity ) was observed and compared before and after treatment separately . The efficacy was evaluated in two groups . RESULTS CTTH score was all reduced after treatment in the two groups ( both P < 0.01 ) , the score in the sticking needling group was lower than that in the acupuncture group ( 2.38 +/- 1.22 vs 4.16 +/- 2.54 , P < 0.01 ) . The effective rate was 97.3 % ( 146/150 ) in the sticking needling group , which was better than 88.4 % ( 122/138 ) in the acupuncture group ( P < 0.05 ) . CONCLUSION The manual sticking needling technique at galea tendon-muscle node achieves the superior results of reducing the pain attack frequency and severity of CTTH as compared with the acupuncture therapy of the routine acupoint selection .

sticking needling group

acupuncture group

sticking needling

the manual sticking needling technique

acupuncture

acupuncture

manual sticking needling technique

chronic tension-type headache

CTTH score

score in the sticking needling group

reducing the pain attack frequency

chronic tension-type headache

chronic tension-type headache ( CTTH )

Two hundred and eighty-eight

CTTH


Haloperidol blood levels and effects in schizophrenia and schizoaffective disorder : a progress report . To test the hypothesis of a " therapeutic window , " we have randomly assigned acutely exacerbating schizophrenic or schizoaffective patients to one of three plasma levels of haloperidol ( HAL ) : 2-13 , 13.1-24 , or 24.1-35 ng/ml . Patients who did not improve after 6 weeks of this treatment were randomly assigned to one of the three haloperidol levels for another 6 weeks . The improvement was defined as at least 50 percent reduction of the Brief Psychiatric Rating Scale ( BPRS ) total score . The results obtained in 111 patients do not support any consistent relationship between plasma level of haloperidol and clinical improvement . Patients in the high haloperidol plasma range tended to have more side effects . These results suggest that the haloperidol doses used in clinical practice may be higher than necessary .

Haloperidol

haloperidol ( HAL )

haloperidol

haloperidol

haloperidol

haloperidol

schizophrenia

schizoaffective

schizophrenic

schizoaffective

plasma level of haloperidol

clinical improvement .

side effects .

schizophrenia

schizoaffective disorder

schizophrenic

schizoaffective

111 patients


Yoga effects on mood and quality of life in Chinese women undergoing heroin detoxification : a randomized controlled trial . BACKGROUND Yoga , as a mind-body therapy , is effective in improving quality of life for patients with chronic diseases , yet little is known about its effectiveness in female heroin addicts . OBJECTIVES The aim of this study was to evaluate the effects of yoga on mood status and quality of life among women undergoing detoxification for heroin dependence in China . METHOD This study was a randomized controlled trial . Seventy-five women aged 20-37 years undergoing detoxification for heroin dependence at AnKang Hospital were allocated randomly into an intervention or a control group . Women in the intervention group received a 6-month yoga intervention in addition to hospital routine care , and women in the control group received hospital routine care only . Mood status and quality of life were assessed using the Profile of Mood States and Medical Outcomes Study 36-item Short-Form Health Survey at baseline and following 3 and 6 months of treatment . Repeated-measures analysis of variance was used to evaluate treatment and time effects on mood and quality of life . RESULTS Most female heroin addicts were young and single , with a low education level . Most had used heroin by injection . Mood state and quality of life of female heroin addicts were poor . The intervention group showed a significant improvement in mood status and quality of life over time compared with their counterparts in the control group . CONCLUSION Yoga may improve mood status and quality of life for women undergoing detoxification for heroin dependence . Yoga can be used as an auxiliary treatment with traditional hospital routine care for these women .

yoga

intervention

control group

6-month yoga intervention

hospital routine care only .

mood

quality of life

effects

mood status and quality of life

Mood status and quality of life

mood

Mood state and quality of life

mood status and quality of life

women

heroin detoxification

Seventy-five

20-37 years

female

heroin addicts


Prospective investigation of body mass index , colorectal adenoma , and colorectal cancer in the prostate , lung , colorectal , and ovarian cancer screening trial . PURPOSE Obesity has consistently been linked to an increased risk of colorectal cancer , particularly among men . Whether body mass index ( BMI ) differentially influences the risk across the stages of colorectal cancer development remains unclear . We evaluated the associations of BMI with colorectal adenoma incidence , adenoma recurrence , and cancer in the context of a large screening trial , in which cases and controls had an equal chance for disease detection . METHODS We prospectively evaluated the association between baseline BMI and the risk of incident distal adenoma ( 1,213 cases ) , recurrent adenoma ( 752 cases ) , and incident colorectal cancer ( 966 cases ) among men and women , ages 55 to 74 years , randomly assigned to receive flexible sigmoidoscopy screening as part of the Prostate , Lung , Colorectal , and Ovarian Cancer Screening Trial . We calculated odds ratios ( ORs ) and 95 % CIs for adenoma incidence and recurrence , and hazard ratios ( HRs ) and 95 % CIs for colorectal cancer incidence , using multivariable-adjusted models . RESULTS Compared with normal-weight men ( 18.5 to 24.9 kg/m ( 2 ) ) , obese men ( ≥ 30 kg/m ( 2 ) ) had significantly higher risk of incident adenoma ( OR , 1.32 ; 95 % CI , 1.06 to 1.65 ) and colorectal cancer ( HR , 1.48 ; 95 % CI , 1.16 to 1.89 ) and a borderline increased risk of recurrent adenoma ( OR , 1.50 ; 95 % CI , 0.98 to 2.30 ) . No associations were observed for either adenoma or cancer in women . CONCLUSION Data from this large prospective study suggest that obesity is important throughout the natural history of colorectal cancer , at least in men , and colorectal cancer prevention efforts should encourage the achievement and maintenance of a healthy body weight in addition to regular screenings .

flexible sigmoidoscopy screening

colorectal adenoma

colorectal cancer

risk of colorectal cancer

colorectal adenoma incidence

adenoma recurrence , and cancer

incident distal adenoma

recurrent adenoma

incident colorectal cancer

odds ratios ( ORs ) and 95 % CIs

adenoma incidence and recurrence

hazard ratios ( HRs )

95 % CIs

colorectal cancer incidence


Learning curve in multidetector CT coronary angiography ( MDCT-CA ) . PURPOSE Coronary angiography using multidetector computed tomography ( MDCT-CA ) is a recent technique for the nonivasive study of coronary arteries . This study assessed the diagnostic accuracy of coronary artery stenosis evaluation obtained by three readers at different levels of training or at different points of the learning curve proposed by the international guidelines . MATERIALS AND METHODS Three radiologists in training with different levels of experience in MDCT-CA scored 50 cases at various time points of the learning curve : baseline , 4 weeks , 8 weeks and 6 months . The trainee radiologists evaluated the degree of stenosis on each coronary segment , and overall accuracy was calculated on a per-segment , pervessel and per-patient basis . RESULTS All readers improved analysis accuracy per segment ( range , 73-90 % ) ; sensitivity reached 45 % per segment , 84 % per vessel and 93 % per patient ; specificity was 99 % per segment and vessel and 98 % per patient . Positive and negative predictive values increased to 94 % and 92 % , respectively . CONCLUSIONS Although all readers improved in diagnostic performance with growing experience with MDCT-CA , a longer training period may be necessary to achieve adequate levels of expertise in MDCT-CA to be able to perform as independent readers .

multidetector CT coronary angiography

longer training period

overall accuracy

improved analysis accuracy per segment

sensitivity

specificity

diagnostic performance


The effectiveness of educational interventions to enhance the adoption of fee-based arsenic testing in Bangladesh : a cluster randomized controlled trial . Arsenic ( As ) testing could help 22 million people , using drinking water sources that exceed the Bangladesh As standard , to identify safe sources . A cluster randomized controlled trial was conducted to evaluate the effectiveness of household education and local media in the increasing demand for fee-based As testing . Randomly selected households ( N = 452 ) were divided into three interventions implemented by community workers : 1 ) fee-based As testing with household education ( HE ) ; 2 ) fee-based As testing with household education and a local media campaign ( HELM ) ; and 3 ) fee-based As testing alone ( Control ) . The fee for the As test was US $ 0.28 , higher than the cost of the test ( US $ 0.16 ) . Of households with untested wells , 93 % in both intervention groups HE and HELM purchased an As test , whereas only 53 % in the control group . In conclusion , fee-based As testing with household education is effective in the increasing demand for As testing in rural Bangladesh .

educational interventions

household education and local media

fee-based As testing alone ( Control )

adoption of fee-based arsenic testing

HE and HELM purchased an As test

fee-based As testing

Bangladesh

Randomly selected households

rural Bangladesh


Anxiolytics in patients suffering a suspected acute coronary syndrome : multi-centre randomised controlled trial in Emergency Medical Service . BACKGROUND The prehospital treatment of pain and discomfort among patients who suffer from acute coronary syndrome ( ACS ) needs a treatment strategy which combines relief of pain with relief of anxiety . AIM The aim of the present study was to evaluate the impact on pain and anxiety of the combination of an anxiolytic and an analgesic as compared with an analgesic alone in the prehospital setting of suspected ACS . METHODS A multi-centre randomised controlled trial compared the combination of Midazolam ( Mi ) +Morphine ( Mo ) and Mo alone . All measures took part : Prior to randomisation , 15 min thereafter and on admission to a hospital . Inclusion criteria were : 1 ) pain raising suspicion of ACS and 2 ) pain score ≥4 . PRIMARY ENDPOINT Pain score after 15 min . RESULTS In all , 890 patients were randomised to Mi+Mo and 873 to Mo alone . Pain was reduced from a median of 6 to 4 and finally to 3 in both groups . The mean dose of Mo was 5.3 mg in Mi+Mo and 6.0 mg in Mo alone ( p < 0.0001 ) . Anxiety was reported in 66 % in Mi+Mo and in 64 % in Mo alone at randomisation ( NS ) ; 15 min thereafter in 31 % and 39 % ( p=0.002 ) and finally in 12 % and 26 % respectively ( p < 0.0001 ) . On admission to a hospital nausea or vomiting was reported in 9 % in Mi+Mo and in 13 % in Mo alone ( p=0.003 ) . Drowsiness differed ; 15 % and 14 % were drowsy in Mi+Mo versus 2 % and 3 % in Mo alone respectively ( p < 0.001 ) . CONCLUSION Despite the fact that the combination of anxiolytics and analgesics as compared with analgesics alone reduced anxiety and the requirement of Morphine in the prehospital setting of acute coronary syndrome , this strategy did not reduce patients ' estimation of pain ( primary endpoint ) . More effective pain relief among these patients is warranted .

Anxiolytics

anxiolytic

analgesic

Midazolam ( Mi ) +Morphine ( Mo )

Mo alone

Pain

Anxiety

nausea or vomiting

Drowsiness

acute coronary syndrome

890 patients


A randomised trial comparing preoperative to perioperative chemotherapy in early-stage non-small-cell lung cancer ( IFCT 0002 trial ) . HYPOTHESIS There will be a detectable increase in overall survival ( OS ) using preoperative ( PRE ) as opposed to perioperative ( PERI ) chemotherapy in resectable StageI-II non-small-cell lung cancer ( NSCLC ) . METHODS This multicenter , open-label , randomised trial with a 2×2 factorial design first compared two chemotherapy strategies ( PRE versus PERI ) , then two chemotherapy regimens ( gemcitabine-cisplatin [ GP ] versus paclitaxel-carboplatin [ TC ] ) . The PRE group received two preoperative cycles followed by two additional preoperative cycles , while the PERI group underwent two preoperative cycles followed by two postoperative cycles , the 3rd and 4th cycles being given only to responders in both cases . RESULTS A total of 528 patients were randomised , 267 of which were assigned to the PRE group and 261 to the PERI group . Three-year OS did not differ between the two groups ( 67.4 % and 67.7 % , respectively ; hazard ratio ( HR ) =1.01 [ 0.79-1.30 ] , p=0.92 ) , nor did 3-year disease-free survival , response rates , toxicity , or postoperative mortality . Pathological complete response was observed in 22 ( 8.2 % ) and 16 patients ( 6.1 % ) , respectively . Although quality of life did not differ significantly , chemotherapy compliance was significantly higher in the PRE group . The proportion of responders who received Cycles 3 and 4 was significantly higher in the PRE group ( 90.4 % versus 75.2 % , p=0.001 ) . In responders , the dose intensity of Cycles 3 and 4 was higher in the PRE group than in the PERI group ( mean relative dose intensity of 90.4 % versus 82.6 % , respectively ; p=0.0007 ) . There was no difference between GP and TC in 3-year OS ( HR=0.97 [ 95 % confidence interval ( CI ) : 0.76-1.25 ] , p=0.80 ) or response rates . However , the regimens ' toxicity profiles differed . CONCLUSIONS This study failed to demonstrate any difference in survival between patients receiving preoperative and perioperative chemotherapy in early-stage NSCLC . The increase from two to four preoperative chemotherapy cycles did not increase the pathological response rate .

overall survival ( OS )


Nicotinic acid as therapy for dyslipidemia in non-insulin-dependent diabetes mellitus . Recently , nicotinic acid has been recommended as a first-line hypolipidemic drug . To determine the effectiveness of nicotinic acid in dyslipidemic patients with non-insulin-dependent diabetes mellitus , 13 patients were treated in a randomized crossover trial . Patients received either nicotinic acid ( 1.5 g three times daily ) or no therapy ( control period ) for 8 weeks each . Compared with the control period , nicotinic acid therapy reduced the plasma total cholesterol level by 24 % , plasma triglyceride level by 45 % , very-low-density lipoprotein cholesterol level by 58 % , and low-density lipoprotein cholesterol level by 15 % , and it increased the high-density lipoprotein cholesterol level by 34 % . However , nicotinic acid therapy resulted in the deterioration of glycemic control , as evidenced by a 16 % increase in mean plasma glucose concentrations , a 21 % increase in glycosylated hemoglobin levels , and the induction of marked glycosuria in some patients . Furthermore , a consistent increase in plasma uric acid levels was observed . Therefore , despite improvement in lipid and lipoprotein concentrations , because of worsening hyperglycemia and the development of hyperuricemia , nicotinic acid must be used with caution in patients with non-insulin-dependent diabetes mellitus with dyslipidemia . We suggest that the drug not be used as a first-line hypolipidemic drug in patients with non-insulin-dependent diabetes mellitus .

Nicotinic acid

nicotinic acid

nicotinic acid

no therapy

nicotinic acid

nicotinic acid

plasma total cholesterol level

plasma triglyceride level

deterioration of glycemic control

mean plasma glucose concentrations

glycosylated hemoglobin levels

marked glycosuria

plasma uric acid levels

lipid and lipoprotein concentrations

hyperglycemia

hyperuricemia


A randomized , double-blind , placebo-controlled trial of the effect of dried purple carrot on body mass , lipids , blood pressure , body composition , and inflammatory markers in overweight and obese adults : the QUENCH trial . Obesity is a significant health issue worldwide and is associated with chronic , low-grade inflammation predisposing the individual to cardiovascular disease and impaired blood glucose homeostasis . Anthocyanins and phenolic acids from purple carrots are effective at reversing inflammation and metabolic alterations in animal models , potentially through inhibition of inflammatory pathways . The effects of dried purple carrot on body mass , body composition , blood pressure , lipids , inflammatory markers , liver function tests , and appetite were investigated in 16 males ( aged 53.1 ± 7.6 years and with a mean BMI of 32.8 ± 4.6 kg/m ( 2 ) ) with normal lipid and inflammatory markers . There was no evidence that 118.5 mg/day of anthocyanins and 259.2 mg/day of phenolic acids for 4 weeks resulted in statistically significant changes in body mass , body composition , appetite , dietary intake , low density lipoprotein , total cholesterol , blood pressure , or C-reactive protein in these obese participants at the dose and length of intervention used in this trial . High density lipoprotein cholesterol was lower in the intervention group ( p < 0.05 ) . Aspartate amino transferase and alanine amino transferase did not change , indicating that the intervention was safe . More studies are required to establish the bioavailability and pharmacokinetic effects of purple carrot anthocyanins and phenolic acids prior to further trials of efficacy with respect to treating inflammation and metabolic alterations .

placebo-controlled

dried purple carrot

dried purple carrot

body mass

body composition

blood pressure

lipids

inflammatory markers

liver function tests

appetite

overweight and obese

adults

males

aged 53.1 ± 7.6 years


Concomitant , sequential , and hybrid therapy for H. pylori eradication : a pilot study . BACKGROUND AND OBJECTIVE Since the efficacy of the standard triple therapies for Helicobacter pylori eradication has decreased , novel antibiotic regimens have been introduced , including concomitant , sequential , and hybrid therapies . We aimed to compare the cure rates achieved by these new therapy regimens . METHODS This was a multicenter , open-label , pilot study enrolling consecutive non-ulcer dyspepsia patients with H. pylori infection never previously treated for the infection . Patients were randomized to receive one of the following treatments : ( a ) concomitant therapy : omeprazole 20mg , amoxicillin 1g , clarithromycin 500 mg , and tinidazole 500 mg for 5 days ; ( b ) sequential therapy : omeprazole 20mg and amoxicillin 1g for 5 days followed by omeprazole 20mg , clarithromycin 500 mg , and tinidazole 500 mg for 5 days ; ( c ) hybrid therapy : omeprazole 20mg , and amoxicillin 1g for 7 days followed by omeprazole 20mg , amoxicillin 1g , clarithromycin 500 mg , and tinidazole 500 mg , for 7 days . All drugs were administered twice daily . Bacterial eradication was checked 6 weeks after treatment by using a ( 13 ) C-urea breath test . A 10-day , second-line therapy with omeprazole 20mg , levofloxacin 250 mg , and amoxicillin 1g , all given twice daily , was offered to the eradication failure patients . RESULTS Overall , 270 patients were enrolled , but 13 patients early interrupted treatment due to side effects . At intention-to-treat ( ITT ) and per-protocol analysis ( PP ) , the eradication rates were 85.5 % and 91.6 % with the concomitant regimen , 91.1 % and 92.1 % with the sequential therapy , and 80 % and 85.7 % with the hybrid regimen . Differences were not statistically significant . H. pylori infection was cured in 10 ( 55.6 % ) patients with the second-line regimen . CONCLUSION In our study , both concomitant and sequential therapy , but not hybrid therapy , reached high eradication rates . The success rate of second-line levofloxacin-based triple therapy is decreasing .

novel antibiotic regimens

including concomitant , sequential

hybrid therapies

concomitant therapy : omeprazole

amoxicillin

clarithromycin

tinidazole

sequential therapy : omeprazole

amoxicillin

omeprazole

clarithromycin

tinidazole

hybrid therapy : omeprazole

amoxicillin

omeprazole

amoxicillin

clarithromycin

tinidazole

( 13 ) C-urea breath test

second-line therapy

omeprazole

levofloxacin

amoxicillin

concomitant regimen

sequential therapy

hybrid regimen

second-line regimen

concomitant

pylori eradication

cure rates

Bacterial eradication

eradication rates

pylori infection

cured

eradication rates

success rate

non-ulcer dyspepsia

H. pylori infection


Ultracision versus electrocautery in performing modified radical mastectomy and axillary lymph node dissection for breast cancer : a prospective randomized control trial . BACKGROUND Treatment for breast cancer has improved dramatically over the decades . Nevertheless , modified radical mastectomy with axillary dissection remains the standard treatment for most patients , especially those with big tumours . The conventional technology is to use diathermy to cut and coagulate blood vessels . The Ultracision dissector has been widely used in laparoscopic surgery and is documented to be safe and fast for cutting and coagulating tissue . The aim of this study is to compare ultracision to electrocautery , looking in terms of amount of post operative drainage , duration of drain days , seroma formation and other complications . METHODOLOGY This study was a prospective randomized control trial of modified radical mastectomy performed for breast cancer in Pusat Perubatan Universiti Kebangsaan Malaysia ( PPUKM ) between 1st June 2007 to 31st December 2008 . Patients were randomized in two groups : group A ( n = 20 ) underwent modified radical mastectomy using ultracision ( UC ) and group B ( n = 20 ) with the conventional electrocautery ( EC ) method . Main outcome measures were amount of drainage and duration of drain days . An unpaired 2-tailed Student 's t test and the χ2 test to compare the groups . RESULTS A total of 40 patients were involved in this study . The majority of patients were Malay ( 55 % ) followed by Chinese ( 35 % ) , Indian ( 5 % ) and others ( 5 % ) . The mean volume of drainage from the axilla in the EC group was significantly higher than UC group [ 489.5 versus 188.1 mls ( p < 0.001 ) ] . The mean volume of drainage from the breast and the total drainage from both the breast and axilla was also significantly higher in the EC group compared to UC [ 169.3 versus 58.8 mls ( p = 0.004 ) and 663.7 versus 247.0 mls ( p < 0.002 ) respectively ] . The drainage consequently showed significant reduction in terms of drain days in the axilla [ 6 days versus 3 days ( p < 0.002 ) ] and the breast [ 3 days versus 2 days ( p < 0.002 ) ] in the UC compared to the EC . There was no significant complication in both arms . In conclusion , the use of ultracision able to reduce the amount of drainage and the number of drain days after performing modified radical mastectomy . In doing so , the use of this technology enable us to discharge patients earlier without significant morbidities .

Ultracision

electrocautery

ultracision

electrocautery

modified radical mastectomy

amount of drainage

duration of drain days

mean volume of drainage from the axilla

complication

amount of drainage

number of drain days

breast cancer

n = 20


Effect of resistance exercise contraction mode and protein supplementation on members of the STARS signalling pathway . The striated muscle activator of Rho signalling ( STARS ) pathway is suggested to provide a link between external stress responses and transcriptional regulation in muscle . However , the sensitivity of STARS signalling to different mechanical stresses has not been investigated . In a comparative study , we examined the regulation of the STARS signalling pathway in response to unilateral resistance exercise performed as either eccentric ( ECC ) or concentric ( CONC ) contractions as well as prolonged training ; with and without whey protein supplementation . Skeletal muscle STARS , myocardian-related transcription factor-A ( MRTF-A ) and serum response factor ( SRF ) mRNA and protein , as well as muscle cross-sectional area and maximal voluntary contraction , were measured . A single-bout of exercise produced increases in STARS and SRF mRNA and decreases in MRTF-A mRNA with both ECC and CONC exercise , but with an enhanced response occurring following ECC exercise . A 31 % increase in STARS protein was observed exclusively after CONC exercise ( P < 0.001 ) , while pSRF protein levels increased similarly by 48 % with both CONC and ECC exercise ( P < 0.001 ) . Prolonged ECC and CONC training equally stimulated muscle hypertrophy and produced increases in MRTF-A protein of 125 % and 99 % , respectively ( P < 0.001 ) . No changes occurred for total SRF protein . There was no effect of whey protein supplementation . These results show that resistance exercise provides an acute stimulation of the STARS pathway that is contraction mode dependent . The responses to acute exercise were more pronounced than responses to accumulated training , suggesting that STARS signalling is primarily involved in the initial phase of exercise-induced muscle adaptations .

resistance exercise contraction mode

protein supplementation

resistance exercise

prolonged training

whey protein supplementation

exercise

ECC

CONC exercise

ECC exercise

CONC exercise

whey protein supplementation

acute exercise

accumulated training

STARS

SRF mRNA

STARS protein

pSRF

MRTF-A protein

total SRF protein

whey protein supplementation .

acute stimulation of the STARS pathway


Parent-based sleep education for children with autism spectrum disorders . This study provided sleep education to parents of children with autism spectrum disorder ( ASD ) to determine whether an individual or group format was more effective in improving sleep and aspects of daytime behavior and family functioning . Eighty children , ages 2-10 years , with ASD and sleep onset delay completed the study . Actigraphy and parent questionnaires were collected at baseline and 1 month after treatment . Mode of education did not affect outcomes . Sleep latency , insomnia subscales on the Children 's Sleep Habits Questionnaire , and other outcomes related to child and family functioning improved with treatment . Parent-based sleep education , delivered in relatively few sessions , was associated with improved sleep onset delay in children with ASD . Group versus individualized education did not affect outcome .

Parent-based sleep education

sleep education to parents

individual

group format

sleep

daytime behavior

family functioning

family functioning

children

autism spectrum disorders

children

autism spectrum disorder ( ASD )


Ultrasonography-guided bilateral rectus sheath block vs local anesthetic infiltration after pediatric umbilical hernia repair : a prospective randomized clinical trial . IMPORTANCE Regional anesthetic techniques can be used to alleviate postoperative pain in children undergoing pediatric surgical procedures . Use of ultrasonographic guidance for bilateral rectus sheath block ( BRSB ) has been shown to improve immediate pain scores and reduce use of postoperative analgesia in the postanesthesia care unit ( PACU ) . OBJECTIVE To compare efficacy of ultrasonography-guided BRSB and local anesthetic infiltration ( LAI ) in providing postoperative analgesia after pediatric umbilical hernia repair . DESIGN Prospective , observer-blinded , randomized clinical trial . SETTING Tertiary-referral urban children 's hospital . PARTICIPANTS Eligible children 3 to 12 years of age undergoing elective umbilical hernia repair from November 16 , 2009 , through May 31 , 2011 . INTERVENTIONS Ropivacaine hydrochloride administered at the conclusion of surgery as LAI by the surgeon ( n = 25 ) or as ultrasonography-guided BRSB by the anesthesiologist ( n = 27 ) . MAIN OUTCOMES AND MEASURES Scores on the FACES Pain Rating Scale measured at 10-minute intervals and all use of analgesic medications in the PACU . RESULTS Median FACES scores in the PACU were lower in the BRSB group compared with the LAI group at 10 minutes ( 0 vs 1 ; P = .04 ) , 30 minutes ( 0 vs 1 ; P = .01 ) , and 40 minutes or later ( 0 vs 1 ; P = .03 ) . Fewer doses of opioid and nonopioid medications were given to the BRSB group compared with the LAI group ( 5 vs 11 doses for opioids ; 5 vs 10 for nonopioids ) . CONCLUSIONS AND RELEVANCE In the PACU , ultrasonography-guided BRSB after umbilical hernia repair in children is associated with lower median FACES scores and decreased use of opioid and nonopioid medications compared with LAI . Future studies could examine the use of longer-acting anesthetic agents with ultrasonography-guided BRSB . TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT01015053 .

local anesthetic infiltration

Regional anesthetic techniques

Ropivacaine hydrochloride

surgery


Prospective , blinded exploratory evaluation of the PlayWisely program in children with autism spectrum disorder . The purpose of the study was to explore a low-cost intervention that targets an increasingly common developmental disorder . The study was a blinded , exploratory evaluation of the PlayWisely program on autism symptoms and essential learning foundation skills ( attention , recognition , and memory skills ) in children with a diagnosis of autism , autism spectrum disorder ( ASD ) , pervasive developmental disorder - not otherwise specified ( PDD-NOS ) , and Asperger syndrome ( AS ) . Eighteen children , 1 to 10 years of age , were evaluated using the Childhood Autism Rating Scale , Second Edition ( CARS2 ) ; the PlayWisely Interactive Test of Attention , Recognition , and Memory Skills ; Autism Treatment Evaluation Checklist ( ATEC ) , and the Modified Checklist for Autism in Toddlers ( M-CHAT ) . There were significant treatment effects for the PlayWisely measure on the Yellow Sets that examine recognition ; Purple Sets that examine brain region agility and early memory skills ; Blue Sets that examine phonemic awareness and recognition ; and for the Total Sets , with a similar trend toward improvement in the Green Sets that examine perception and Red Sets that examine attention . No other measures reached statistical significance . The results suggest that PlayWisely can improve recognition , brain region agility , phonemic awareness , letter recognition , and early memory skills in ASD . It was observed by the parents , coaches , and study investigators that the children who were less than 3 years of age showed improvements in autism symptoms ; however , the group was too small to reach statistical significance . Future studies are needed to see if this intervention can mitigate autism symptoms in very young children with ASD .

PlayWisely program

low-cost intervention

PlayWisely program

recognition

brain region agility

early memory skills

phonemic awareness

recognition

recognition

brain region agility

phonemic awareness

letter recognition

early memory skills

autism symptoms

children

autism spectrum disorder

children

diagnosis of autism

autism spectrum disorder ( ASD )

pervasive developmental disorder

not otherwise specified ( PDD-NOS )

and Asperger syndrome ( AS )

Eighteen

children

1 to 10 years of age


Targeting alpha-7 nicotinic neurotransmission in schizophrenia : a novel agonist strategy . Alpha7 nicotinic acetylcholine receptor ( α7 nAChR ) agonists may be valuable treatments for negative symptoms and cognitive impairment in schizophrenia . Unfortunately , chronic exposure to an agonist may reduce the receptor 's sensitivity . Therefore , we combined CDP-choline , a dietary source of the direct agonist choline , with galantamine , a positive allosteric modulator ( PAM ) of nicotinic acetylcholine receptors , to improve the efficiency of transducing the choline signal and , possibly , preserve the receptor in a sensitive state . We conducted a single-site , double-blind randomized clinical trial comparing galantamine/CDP-choline to placebos in schizophrenia patients with negative symptoms who were receiving second generation antipsychotics . Forty-three subjects received galantamine and CDP-choline or matching placebos for 16weeks . The primary outcome measure was the 5-item Marder negative-symptoms factor of the Positive and Negative Syndrome Scale ( PANSS ) . Cognition and functioning were also assessed . Trial completion was high ; 79 % . There was no significant treatment effect on negative symptoms , other PANSS symptom factors , or the MATRICS Cognitive Consensus Battery . There were significant treatment effects in overall functioning and a test of free verbal recall . Three subjects discontinued treatment in the active treatment group for gastro-intestinal adverse events ( AE ) . The most common AE for galantamine/CDP-choline was abdominal pain ; for placebo it was headache and sweating . Although there was no significant treatment effect on negative symptoms , the direction of effect mirrored the effects on a cognitive measure and overall functioning . Further study of α7 nAChR agonist/PAMs is warranted in larger studies that will have greater power .

alpha-7 nicotinic neurotransmission

schizophrenia :


Does the result of completion axillary lymph node dissection influence the recommendation for adjuvant treatment in sentinel lymph node-positive patients ? OBJECTIVE The Hungarian National Institute of Oncology has just closed a single-center randomized clinical study . The Optimal Treatment of the Axilla-Surgery or Radiotherapy ( OTOASOR ) trial compares completion axillary lymph node dissection ( cALND ) with regional nodal irradiation ( RNI ) in patients with sentinel lymph node-positive ( SLN+ ) primary invasive breast cancer . In the investigational treatment arm , patients received 50 Gy RNI instead of cALND . In these patients we had information only about the sentinel lymph node ( SLN ) status , but the further axillary nodal involvement remained unknown . The aim of this study was to investigate whether the result of cALND influenced the recommendation for adjuvant treatment in patients with SLN+ breast cancer . PATIENTS AND METHODS Patients with SLN+ primary breast cancer were randomized for cALND ( arm A , standard treatment ) or RNI ( arm B , investigational treatment ) . Adjuvant systemic treatments were given according to the standard institutional protocol , and patients were followed according to the actual institutional guidelines . RESULTS Between August 2002 and June 2009 , 474 SLN+ patients were randomized to cALND ( arm A , standard treatment = 244 patients ) or RNI ( arm B , investigational treatment = 230 patients ) . The 2 arms were well balanced according to the majority of main prognostic factors . However , more patients were premenopausal ( 34 % vs. 27 % ; P = .095 ) and had pT2-3 tumors ( 57 % vs. 40 % ; P = .003 ) in the completion axillary lymph node dissection ( ALND ) arm . On the other hand , there were more patients with known human epidermal growth factor receptor type 2 positive tumor ( 12 % vs. 17 % , P = .066 ) in the RNI arm . In the ALND and RNI arms , 78 % ( 190/244 ) and 69 % ( 159/230 ) , respectively , received chemotherapy ( P = .020 ) . Endocrine therapy was administered in 87 % ( 213/244 ) of the patients in the ALND arm and 89 % ( 204/230 ) of the patients in the RNI arm ( P = .372 ) . Six patients ( 2.5 % ) on arm A and 13 patients ( 5.7 % ) on arm B received adjuvant trastuzumab treatment ( P = not significant ) . Subgroup analyses explored that more frequent administration of adjuvant chemotherapy in arm A was associated with the higher percentage of premenopausal patients and patients with larger ( pT2-3 ) tumors . CONCLUSIONS The result of cALND after positive SLN biopsy seems to have no major impact on the administration of adjuvant systemic therapy .

adjuvant treatment

regional nodal irradiation ( RNI )

RNI

cALND

cALND

cALND

cALND

RNI

ALND

RNI

chemotherapy

Endocrine therapy

adjuvant chemotherapy

cALND

adjuvant systemic therapy

sentinel lymph node-positive

SLN+ breast cancer

SLN+ primary breast cancer

SLN+ patients

premenopausal

type 2 positive tumor

premenopausal

larger ( pT2-3 ) tumors


An Exploratory , Open-Label , Randomized Trial Comparing Risperidone Long-Acting Injectable with Oral Antipsychotic Medication in the Treatment of Early Psychosis . Few studies have examined effectiveness and tolerability of risperidone long-acting injections ( RLAI ) in the early phase of a schizophrenia spectrum ( SS ) disorder using a randomized controlled trial ( RCT ) design . Eighty-five patients in early phase of an SS disorder were randomized to receive either oral second-generation antipsychotics ( SGAs ; n=41 ) or RLAI ( n=44 ) over two years . Analyses were conducted on eligible participants ( n=77 ) for the stabilization ( maximum 18 weeks ) and maintenance phases ( up to Week 104 ) on primary outcome measures of time to stabilization and relapse , change in symptoms and safety , and comparisons made across the two groups . Both groups showed improvement on Positive and Negative Syndrome Scale ( PANSS ) scores and Clinical Global Impression-Severity ( CGI-S ) scores . There were no time X group interactions on any of the primary outcome measures . Post hoc examination revealed that the RLAI group showed greater change on CGI-S and PANSS negative symptom scores during the stabilization phase , while the oral group reached the same level of improvement during the maintenance phase . The current exploratory study suggests that-within an RCT design-RLAI and oral SGAs are equally effective and have similar safety profiles in patients in the early phase of SS disorders . Thus , RLAI offers no advantage to patients in early phase of SS disorders , but is likely to be effective and safe for those who may have problems with adherence and may either choose to take it or be prescribed under conditions of external control such as community treatment orders .

Risperidone Long-Acting Injectable

Oral Antipsychotic Medication

RLAI

time to stabilization

relapse

change in symptoms and safety

comparisons

CGI-S

PANSS negative symptom scores

effective

similar safety profiles

effective

safe

Early Psychosis .

schizophrenia spectrum ( SS ) disorder

Eighty-five patients

SS disorder


[ Closure of persistent foramen ovale - the last closure ? ] .

[ Closure of persistent foramen ovale

persistent foramen ovale

persistent foramen ovale


A randomized trial evaluating the effects of change in dairy food consumption on cardio-metabolic risk factors . BACKGROUND It is currently not known whether dairy food influences the risk of cardiovascular disease or diabetes . This study evaluates effects of changing dairy intake on cardio-metabolic risk factors . METHODS 180 healthy volunteers were randomised to increase , reduce or not change their dairy intake for 1 month in response to dietary advice . Body weight , waist circumference , blood pressure , fasting plasma lipids , insulin resistance and C-reactive protein ( CRP ) were measured at baseline and after 1 month and compared by dietary group . RESULTS 176 ( 98 % ) subjects completed the study . Average change in self-reported dairy fat intake for increased dairy food was +0.9 SD 1.1 g/day ( +71 % ) , no change was -2.1 SD 0.4 g/day ( -15 % ) and decreased dairy food was -10.8 SD 1.2 g/day ( -77 % ) respectively . There was no statistically significant change in LDL or HDL cholesterol , triglycerides , systolic or diastolic blood pressure , C-reactive protein , glucose or insulin with 95 % CI standard mean differences < 0.2 for all and CRP < 0.3 . There was a small increase in weight ( +0.4 kg , SD 3.1 ) in those asked to increase dairy food . CONCLUSIONS In healthy volunteers , dietary advice to change dairy intake for 1 month did not have a clinically significant effect on cardio-metabolic risk factors . These observations suggest that dairy food can be included as part of a normal healthy diet without increasing cardio-metabolic risk . TRIAL REGISTRATION NUMBER ACTRN12612000574842 .

dairy food consumption

changing dairy intake

cardio-metabolic risk factors

cardiovascular disease or diabetes

cardio-metabolic risk factors

self-reported dairy fat intake

and decreased dairy food

change

LDL or HDL cholesterol

triglycerides

systolic or diastolic blood pressure

C-reactive protein

glucose or insulin

was a small increase in weight

effect on cardio-metabolic risk

increasing cardio-metabolic

180 healthy volunteers

healthy


Randomized controlled trial of entecavir prophylaxis for rituximab-associated hepatitis B virus reactivation in patients with lymphoma and resolved hepatitis B . PURPOSE The role of antiviral prophylaxis in preventing hepatitis B virus ( HBV ) reactivation before rituximab-based chemotherapy in patients with lymphoma and resolved hepatitis B is unclear . PATIENTS AND METHODS Eighty patients with CD20 ( + ) lymphoma and resolved hepatitis B were randomly assigned to receive either prophylactic entecavir ( ETV ) before chemotherapy to 3 months after completing chemotherapy ( ETV prophylactic group , n = 41 ) or to receive therapeutic ETV at the time of HBV reactivation and hepatitis B surface antigen ( HBsAg ) reverse seroconversion since chemotherapy ( control group , n = 39 ) . RESULTS Fifty-eight patients ( 72.5 % ) were positive for hepatitis B surface antibody , and HBV DNA was undetectable in 50 patients ( 62.5 % ) . During a mean 18-month follow-up period , one patient ( 2.4 % ) in the ETV prophylactic group and seven patients ( 17.9 % ) in the control group developed HBV reactivation ( P = .027 ) . The cumulative HBV reactivation rates at months 6 , 12 , and 18 after chemotherapy were 8 % , 11.2 % , and 25.9 % , respectively , in the control group , and 0 % , 0 % , and 4.3 % in the ETV prophylactic group ( P = .019 ) . Four patients ( 50 % ) in the control group had HBsAg reverse seroconversion after HBV reactivation . The cumulative HBsAg reverse seroconversion rates at months 6 , 12 , and 18 since chemotherapy were 0 % , 6.4 % , and 16.3 % in the control group , respectively , which were significantly higher than those in the ETV prophylactic group ( P = .032 ) . Patients with detectable or undetectable viral load could develop HBV reactivation and HBsAg reverse seroconversion . CONCLUSION Undetectable HBV viral load before chemotherapy did not confer reactivation-free status . Antiviral prophylaxis can potentially prevent rituximab-associated HBV reactivation in patients with lymphoma and resolved hepatitis B .

entecavir prophylaxis

antiviral prophylaxis

rituximab-based chemotherapy

prophylactic entecavir ( ETV

) before

chemotherapy

to 3 months after completing

chemotherapy

( ETV prophylactic group , n = 41 )

ETV

Antiviral prophylaxis

cumulative HBV reactivation rates

HBsAg reverse seroconversion

HBV reactivation

HBsAg reverse seroconversion


Long-term effects of choline on productive performance and egg quality of brown-egg laying hens . A total of five hundred forty 19-wk-old HyLine Brown hens were used to study the long-term effects of increasing choline with 0 ( control ) , 425 , 850 , 1,700 , 3,400 , and 6,800 mg/kg of corn-soybean meal-based diets on productive performance and egg quality . Phase 1 was from 19 to 58 wk , and phase 2 was from 59 to 68 wk . During the whole experimental period , dietary choline had no significant effects on feed intake , egg weight , and egg mass ( P > 0.05 ) . During phase 1 , egg production decreased linearly ( P < 0.05 ) and feed conversion ratio ( FCR ) tended to increase linearly ( P = 0.057 ) with increasing choline level in the diet . Moreover , BW decreased both linearly ( P < 0.01 ) and quadratically ( P < 0.05 ) as choline increased from 0 to 6,800 mg/kg . No significant treatment effects were found for shell thickness and shell strength of eggs ( P > 0.05 ) . However , albumen height and Haugh units increased linearly ( P < 0.01 and P < 0.05 , respectively ) as choline increased during phase 2 . Compared with the control group , diets supplemented with 425 or 850 mg of choline/kg significantly ( P < 0.01 ) improved yolk color during phase 1 . This study indicates that a dietary choline level of no more than 700 mg/kg is sufficient to maintain egg production . The effect of choline on egg quality was minimal when hens were fed a corn-soybean meal-based diet from 19 to 68 wk of age .

choline

corn-soybean meal-based diet

productive performance and egg quality

productive performance and egg quality

feed intake , egg weight , and egg mass

egg production

feed conversion ratio ( FCR )

BW

shell thickness and shell strength

albumen height and Haugh units

yolk color

egg quality

five hundred forty


Markers of systemic inflammation predict survival in patients with advanced renal cell cancer . BACKGROUND The host inflammatory response has a vital role in carcinogenesis and tumour progression . We examined the prognostic value of inflammatory markers ( albumin , white-cell count and its components , and platelets ) in pre-treated patients with advanced renal cell carcinoma ( RCC ) . METHODS Using data from a randomised trial , multivariable proportional hazards models were generated to examine the impact of inflammatory markers and established prognostic factors ( performance status , calcium , and haemoglobin ) on overall survival ( OS ) . We evaluated a new prognostic classification incorporating additional information from inflammatory markers . RESULTS Of the 416 patients , 362 were included in the analysis . Elevated neutrophil counts , elevated platelet counts , and a high neutrophil-lymphocyte ratio were significant independent predictors for shorter OS in a model with established prognostic factors . The addition of inflammatory markers improves the discriminatory value of the prognostic classification as compared with established factors alone ( C-statistic 0.673 vs 0.654 , P=0.002 for the difference ) , with 25.8 % ( P=0.004 ) of patients more appropriately classified using the new classification . CONCLUSION Markers of systemic inflammation contribute significantly to prognostic classification in addition to established factors for pre-treated patients with advanced RCC . Upon validation of these data in independent studies , stratification of patients using these markers in future clinical trials is recommended .

inflammatory markers

platelets

generated

prognostic classification

systemic inflammation

impact of inflammatory markers

prognostic factors

overall survival

Elevated neutrophil counts

elevated platelet counts

high neutrophil-lymphocyte ratio

advanced renal cell cancer

advanced renal cell carcinoma

416 patients


Tetrahydrobiopterin as a treatment for autism spectrum disorders : a double-blind , placebo-controlled trial . OBJECTIVE The purpose of this study was to determine if tetrahydrobiopterin ( BH4 ) reduced core symptoms of autism spectrum disorder ( ASD ) . METHOD In this study , 46 children , 3-7 years of age diagnosed with an ASD were randomly assigned to double-blind treatment with 20 mg/kg/day BH4 or placebo for 16 weeks . The primary outcome measure was the Clinical Global Impressions Improvement and Severity Scales ( CGI-I and CGI-S ) ; secondary outcomes were the Preschool Language Scale-4 ( PLS-4 ) , Social Responsiveness Scale ( SRS ) , Aberrant Behavior Checklist ( ABC ) , and Vineland Adaptive Behavior Scales ( Vineland ) . RESULTS Overall , no differences were found on global improvement as measured with the CGI-I or CGI-S . Secondary measures indicated significant improvements for BH4 relative to placebo with regard to social awareness , autism mannerisms , hyperactivity , and inappropriate speech . Side effects were minimal and similar between both active medication and placebo . CONCLUSIONS These results indicate that BH4 offers promise in reducing symptoms of ASD . Clinical Trials.gov Identifier : NCT00850070 .

Tetrahydrobiopterin

placebo-controlled

tetrahydrobiopterin ( BH4 )

Preschool Language Scale-4 ( PLS-4

Social Responsiveness Scale ( SRS )

Aberrant Behavior Checklist ( ABC )

CGI-I or CGI-S

autism spectrum disorders :


Effects of extended release methylphenidate treatment on ratings of attention-deficit/hyperactivity disorder ( ADHD ) and associated behavior in children with autism spectrum disorders and ADHD symptoms . OBJECTIVE The purpose of this study was to examine the behavioral effects of four doses of psychostimulant medication , combining extended-release methylphenidate ( MPH ) in the morning with immediate-release MPH in the afternoon . METHOD The sample comprised 24 children ( 19 boys ; 5 girls ) who met American Psychiatric Association , Diagnostic and Statistical Manual of Mental Disorders , 4th ed . ( DSM-IV-TR ) criteria for an autism spectrum disorder ( ASD ) on the Autism Diagnostic Interview-Revised ( ADI-R ) and the Autism Diagnostic Observation Schedule ( ADOS ) , and had significant symptoms of attention-deficit/hyperactivity disorder ( ADHD ) . This sample consisted of elementary school-age , community-based children ( mean chronological age=8.8 years , SD=1.7 ; mean intelligence quotient [ IQ ] =85 ; SD=16.8 ) . Effects of four dose levels of MPH on parent and teacher behavioral ratings were investigated using a within-subject , crossover , placebo-controlled design . RESULTS MPH treatment was associated with significant declines in hyperactive and impulsive behavior at both home and school . Parents noted significant declines in inattentive and oppositional behavior , and improvements in social skills . No exacerbation of stereotypies was noted , and side effects were similar to those seen in typically developing children with ADHD . Dose response was primarily linear in the dose range studied . CONCLUSIONS The results of this study suggest that MPH formulations are efficacious and well-tolerated for children with ASD and significant ADHD symptoms .

methylphenidate treatment

immediate-release MPH in the afternoon

MPH

MPH

associated behavior

behavioral effects

parent and teacher behavioral ratings

inattentive and oppositional behavior

social skills

exacerbation of stereotypies

side effects

efficacious and well-tolerated

children

boys

girls

elementary school-age

age=8.8 years

children

ASD

significant ADHD symptoms


Home-based reach-to-grasp training for people after stroke : study protocol for a feasibility randomized controlled trial . BACKGROUND This feasibility study is intended to assess the acceptability of home-based task-specific reach-to-grasp ( RTG ) training for people with stroke , and to gather data to inform recruitment , retention , and sample size for a definitive randomized controlled trial . METHODS/DESIGN This is to be a randomized controlled feasibility trial recruiting 50 individuals with upper-limb motor impairment after stroke . Participants will be recruited after discharge from hospital and up to 12 months post-stroke from hospital stroke services and community therapy-provider services . Participants will be assessed at baseline , and then electronically randomized and allocated to group by minimization , based on the time post-stroke and extent of upper-limb impairment . The intervention group will receive 14 training sessions , each 1 hour long , with a physiotherapist over 6 weeks and will be encouraged to practice independently for 1 hour/day to give a total of 56 hours of training time per participant . Participants allocated to the control group will receive arm therapy in accordance with usual care . Participants will be measured at 7 weeks post-randomization , and followed-up at 3 and 6 months post-randomization . Primary outcome measures for assessment of arm function are the Action Research Arm Test ( ARAT ) and Wolf Motor Function Test ( WMFT ) . Secondary measures are the Motor Activity Log , Stroke Impact Scale , Carer Strain Index , and health and social care resource use . All assessments will be conducted by a trained assessor blinded to treatment allocation . Recruitment , adherence , withdrawals , adverse events ( AEs ) , and completeness of data will be recorded and reported . DISCUSSION This study will determine the acceptability of the intervention , the characteristics of the population recruited , recruitment and retention rates , descriptive statistics of outcomes , and incidence of AEs . It will provide the information needed for planning a definitive trial to test home-based RTG training . TRIAL REGISTRATION ISRCTN ISRCTN56716589 .

Home-based reach-to-grasp training

training sessions

arm therapy

arm function

Action Research Arm Test ( ARAT )

Wolf Motor Function Test ( WMFT )

Motor Activity Log

Stroke Impact Scale

Carer Strain Index

health and social care resource use

Recruitment

, adherence

withdrawals

adverse events ( AEs )

completeness of data

acceptability

after stroke

stroke

upper-limb motor impairment

stroke

stroke


A head-to-head comparison of aripiprazole and risperidone for safety and treating autistic disorders , a randomized double blind clinical trial . Aripiprazole and risperidone are the only FDA approved medications for treating irritability in autistic disorder , however there are no head-to-head data comparing these agents . This is the first prospective randomized clinical trial comparing the safety and efficacy of these two medications in patients with autism spectrum disorders . Fifty nine children and adolescents with autism spectrum disorders were randomized to receive either aripiprazole or risperidone for 2 months . The primary outcome measure was change in Aberrant Behavior Checklist ( ABC ) scores . Adverse events were assessed . Aripiprazole as well as risperidone lowered ABC scores during 2 months . The rates of adverse effects were not significantly different between the two groups . The safety and efficacy of aripiprazole ( mean dose 5.5 mg/day ) and risperidone ( mean dose 1.12 mg/day ) were comparable . The choice between these two medications should be on the basis of clinical equipoise considering the patient 's preference and clinical profile .

aripiprazole

risperidone

Aripiprazole

risperidone

aripiprazole

risperidone

Aripiprazole

autistic disorders

autism spectrum disorders

Fifty nine

children

adolescents

autism spectrum disorders


Impact of MET expression on outcome in BRAF ( V600E/K ) advanced melanoma . AIMS Preclinical data suggest that signalling through the HGF-MET pathway may confer resistance to BRAF inhibition in BRAF ( V600E/K ) melanoma . Therefore , blockade of HGF-MET signalling might be a valid therapeutic strategy , in combination with BRAF inhibition , in BRAF ( V600E/K ) melanoma . The aim of this study was to investigate the clinical relevance of these observations by evaluating the survival impact of MET expression in patients with BRAF ( V600E/K ) advanced melanoma treated with vemurafenib . METHODS AND RESULTS Formalin-fixed tissue blocks were obtained of tumours from patients enrolled in the BRIM2 ( n = 59 ) and BRIM3 ( n = 150 ) trials of vemurafenib in advanced BRAF ( V600E/K ) melanoma . Immunohistochemistry for MET ( SP44 rabbit monoclonal antibody ) was performed with a highly validated assay and clinically validated scoring system . Pretreatment MET expression was frequent at the ≥1 + cutoff ( BRIM3 , 31 % ; BRIM2 , 49 % ) , but relatively infrequent at the ≥2 + cutoff ( BRIM3 , 9 % ; BRIM2 , 19 % ) . Retrospective subset analyses showed that , irrespective of the cutoff used or the treatment arm , MET expression did not show prognostic significance , in terms of objective response rate , progression-free survival , or overall survival . CONCLUSIONS MET is expressed in a proportion of BRAF ( V600E/K ) advanced melanomas . Further analyses on appropriately powered subsets are needed to determine the prognostic and predictive significance of MET in vemurafenib-treated melanoma .

BRAF inhibition

vemurafenib

advanced melanoma

BRAF ( V600E/K ) advanced melanoma


Randomized trial of tailored skin cancer prevention for children : the Project SCAPE family study . This study evaluated a tailored intervention to promote sun protection in parents and their children , hypothesizing that the tailored intervention would lead to improved skin cancer prevention behaviors compared to generic materials . Families were recruited through schools and community centers and were included if there was 1 child in Grades 1-3 at moderate to high risk for skin cancer . Participants were randomized into one of two intervention groups : a tailored intervention , in which they received personalized skin cancer education through the mail ; or a control group who received generic skin cancer information materials . Before and after intervention , parents completed questionnaires about their and their children 's skin cancer risk and prevention knowledge and behaviors . Parents also completed 4-day sun exposure and protection diaries for their child and themselves . Tailored group participants demonstrated significantly greater positive changes in prevention behavior after the intervention , including children 's use of sunscreen , shirts , and hats , and parents ' use of shade , and skin examinations . Effect sizes were small and perceived benefits and social norms mediated intervention effects . Findings from this study support the efficacy of focusing tailored communications to families in order to change skin cancer prevention practices in young children .

tailored intervention

tailored intervention

control group

skin cancer

children

parents

children

young children


Patient satisfaction with nutrition services amongst cancer patients treated with autologous stem cell transplantation : a comparison of usual and extended care . BACKGROUND This study aimed to determine patient satisfaction with clinical nutrition services delivered by an accredited practicing dietitian amongst cancer patients treated with autologous stem cell transplantation that was provided with usual and extended care at 100 days post-transplantation . METHODS Patients were randomised to receive usual nutrition care or extended nutrition care during the course of their stem cell transplantation . After hospital discharge , usual care patients received no further nutrition support , whereas extended care patients received telephone dietary counselling from the same dietitian for up to 100 days post-transplantation . The patient satisfaction with clinical nutrition service questionnaire was completed anonymously at 100 days post-transplantation . Group comparisons were made using independent t-tests . RESULTS Thirty-seven patients consented to participate in the study ( 54 % male ; mean age 58.7 ± 9.5 years ; median body mass index 26.8 kg m ( -2 ) , range 16.4-47.6 kg m ( -2 ) ) ; 33 patients completed the study and 28 patients returned the questionnaire ( response rate = 85 % ) . All components of the questionnaire were rated highly by both groups ; there was no significant difference between the groups ( P > 0.05 ) . Although not statistically significant , extended care patients who received at least three telephone calls rated a higher overall satisfaction compared to those who received less calls ; this difference was clinically important ( score difference = 0.56 ) . CONCLUSIONS Cancer patients treated with autologous stem cell transplantation were satisfied with usual and extended nutrition care . Extended care patients who received at least three telephone calls after hospital discharge were more satisfied than those with less frequent intervention . Further exploration regarding the frequency and intensity of nutrition service is required .

usual

extended care

nutrition services

usual

extended care

Patient satisfaction

telephone

higher overall

Thirty-seven patients

54 %

male

mean age 58.7 ± 9.5 years ;

median body mass index 26.8 kg m ( -2

range 16.4-47.6 kg m ( -2 ) )

28 patients

difference = 0.56

extended nutrition care


Arm-cranking exercise reduced oxidative damage in adults with chronic spinal cord injury . OBJECTIVE To assess the effect of a 12-week arm-cranking exercise program on reducing oxidative damage in untrained adults with chronic spinal cord injury ( SCI ) . DESIGN Randomized controlled trial . SETTING Community-based supervised intervention . PARTICIPANTS Male adults with complete SCI at or below the fifth thoracic level ( T5 ) ( N=17 ) volunteered for this study . Participants were randomly allocated to the intervention ( n=9 ) or control ( n=8 ) group using a concealed method . INTERVENTION A 12-week arm-cranking exercise program , 3 sessions/wk , consisting of warming-up ( 10-15min ) followed by a main part in arm-crank ( 20-30min [ increasing 2min and 30s every 3wk ] ) at a moderate work intensity of 50 % to 65 % of the heart rate reserve ( starting at 50 % and increasing 5 % every 3 weeks ) and by a cooling-down period ( 5-10min ) . MAIN OUTCOME MEASURES Plasmatic levels of total antioxidant status as well as erythrocyte glutathione peroxidase activity were measured . Lipid and protein oxidation were determined as malondialdehyde and carbonyl group levels , respectively . Furthermore , physical fitness and body composition were assessed . RESULTS When compared with baseline results , maximum oxygen consumption was significantly increased ( P=.031 ) , suggesting an improvement in physical fitness in the intervention group . Regarding the antioxidant defense system , it was found that both total antioxidant status ( P=.014 ) and erythrocyte glutathione peroxidase activity ( P=.027 ) were significantly increased at the end of the training program . As a consequence , plasmatic levels of malondialdehyde ( P=.008 ) and carbonyl groups ( P=.022 ) were significantly reduced . CONCLUSION A 12-week arm-cranking exercise program improved the antioxidant defense system in adults with chronic SCI , which may finally attenuate both lipid and protein oxidation in this population .

Arm-cranking exercise

arm-cranking exercise program

control

12-week arm-cranking exercise program

cooling-down

arm-cranking exercise program

oxidative damage

oxidative damage

Lipid and protein oxidation

physical fitness and body composition

maximum oxygen consumption

physical fitness

total antioxidant status

plasmatic levels of malondialdehyde

antioxidant defense system

lipid and protein oxidation


Comparative efficacy of LEAP , TEACCH and non-model-specific special education programs for preschoolers with autism spectrum disorders . LEAP and TEACCH represent two comprehensive treatment models ( CTMs ) that have been widely used across several decades to educate young children with autism spectrum disorders . The purpose of this quasi-experimental study was to compare high fidelity LEAP ( n = 22 ) and TEACCH ( n = 25 ) classrooms to each other and a control condition ( n = 28 ) , in which teachers in high quality special education programs used non-model-specific practices . A total of 198 children were included in data analysis . Across conditions , children 's performances improved over time . This study raises issues of the replication of effects for CTMs , and whether having access to a high quality special education program is as beneficial as access to a specific CTM .

LEAP , TEACCH

LEAP and TEACCH

high fidelity LEAP

TEACCH

preschoolers

autism spectrum disorders

young children

children


Measuring the plasticity of social approach : a randomized controlled trial of the effects of the PEERS intervention on EEG asymmetry in adolescents with autism spectrum disorders . This study examined whether the Program for the Education and Enrichment of Relational Skills ( PEERS : Social skills for teenagers with developmental and autism spectrum disorders : The PEERS treatment manual , Routledge , New York , 2010a ) affected neural function , via EEG asymmetry , in a randomized controlled trial of adolescents with Autism spectrum disorders ( ASD ) and a group of typically developing adolescents . Adolescents with ASD in PEERS shifted from right-hemisphere gamma-band EEG asymmetry before PEERS to left-hemisphere EEG asymmetry after PEERS , versus a waitlist ASD group . Left-hemisphere EEG asymmetry was associated with more social contacts and knowledge , and fewer symptoms of autism . Adolescents with ASD in PEERS no longer differed from typically developing adolescents in left-dominant EEG asymmetry at post-test . These findings are discussed via the Modifier Model of Autism ( Mundy et al . in Res Pract Persons Severe Disabl 32 ( 2 ) :124 , 2007 ) , with emphasis on remediating isolation/withdrawal in ASD .

PEERS intervention

EEG asymmetry

PEERS

PEERS

PEERS

neural function , via EEG asymmetry

left-hemisphere EEG asymmetry

EEG asymmetry

social contacts and knowledge

symptoms of autism

left-dominant EEG asymmetry

adolescents

autism spectrum disorders

teenagers

autism spectrum disorders

adolescents

Autism spectrum disorders ( ASD )

adolescents

Adolescents

ASD in PEERS

Adolescents


Perceptual learning of speech under optimal and adverse conditions . Humans have a remarkable ability to understand spoken language despite the large amount of variability in speech . Previous research has shown that listeners can use lexical information to guide their interpretation of atypical sounds in speech ( Norris , McQueen , & Cutler , 2003 ) . This kind of lexically induced perceptual learning enables people to adjust to the variations in utterances due to talker-specific characteristics , such as individual identity and dialect . The current study investigated perceptual learning in two optimal conditions : conversational speech ( Experiment 1 ) versus clear speech ( Experiment 2 ) , and three adverse conditions : noise ( Experiment 3a ) versus two cognitive loads ( Experiments 4a and 4b ) . Perceptual learning occurred in the two optimal conditions and in the two cognitive load conditions , but not in the noise condition . Furthermore , perceptual learning occurred only in the first of two sessions for each participant , and only for atypical /s/ sounds and not for atypical /f/ sounds . This pattern of learning and nonlearning reflects a balance between flexibility and stability that the speech system must have to deal with speech variability in the diverse conditions that speech is encountered .

Perceptual learning of speech

lexical information

lexically induced perceptual learning

perceptual learning

conversational speech ( Experiment

clear speech

noise

two cognitive loads

Perceptual learning

optimal conditions

cognitive load conditions

noise condition

perceptual learning

Perceptual learning of speech

perceptual learning

perceptual learning

Perceptual learning

perceptual learning

Humans


Beliefs underlying the intention to donate again among first-time blood donors who experience a mild adverse event . Using the belief basis of the theory of planned behavior ( TPB ) , the current study explored the rate of mild reactions reported by donors in relation to their first donation and the intention and beliefs of those donors with regard to returning to donate again . A high proportion of first-time donors indicated that they had experienced a reaction to blood donation . Further , donors who reacted were less likely to intend to return to donate . Regression analyses suggested that targeting different beliefs for those donors who had and had not reacted would yield most benefit in bolstering donors ' intentions to remain donating . The findings provide insight into those messages that could be communicated via the mass media or in targeted communications to retain first-time donors who have experienced a mild vasovagal reaction .

Beliefs

targeting different beliefs

messages

rate of mild reactions


Riluzole as an adjunctive therapy to risperidone for the treatment of irritability in children with autistic disorder : a double-blind , placebo-controlled , randomized trial . BACKGROUND A hyperglutamatergic state has been shown to play a possible role in the pathophysiology of autistic disorders . Riluzole is a glutamate-modulating agent with neuroprotective properties , which has been shown to have positive effects in many neuropsychiatric disorders . OBJECTIVE The aim of this study was to assess the efficacy and tolerability of riluzole as an adjunctive to risperidone in the treatment of irritability in autistic children who were not optimally responding to previous medications . STUDY DESIGN This was a 10-week , randomized , double-blind , parallel-group , placebo-controlled trial . PARTICIPANTS The study enrolled male and female outpatients aged 5-12 years with a diagnosis of autistic disorder based on the DSM-IV-TR criteria and a score of ≥12 on the Aberrant Behavior Checklist-Community ( ABC-C ) irritability subscale who had discontinued other medications because of a lack of efficacy . INTERVENTIONS Subjects received riluzole ( titrated to 50 or 100 mg/day based on bodyweight ) or placebo in addition to risperidone ( titrated up to 2 or 3 mg/day based on bodyweight ) for 10 weeks . OUTCOME Patients were assessed at baseline , week 5 , and week 10 . The primary outcome measure was the difference in the change in the ABC-C irritability subscale score from baseline to week 10 between the two groups . We also compared changes in other ABC-C subscale scores and Clinical Global Impressions-Improvement ( CGI-I ) scale scores between the two groups . RESULTS Forty-nine patients were enrolled in the study , and forty children completed the trial ( dropouts : placebo = 4 , riluzole = 5 ) . A significantly greater improvement in the study primary outcome ( the ABC-C irritability subscale score ) was achieved by the riluzole-treated children compared with the placebo group ( P = 0.03 ) . Patients in the riluzole group also showed significantly greater improvement on the lethargy/social withdrawal ( P = 0.02 ) , stereotypic behavior ( P = 0.03 ) , and hyperactivity/non-compliance subscales ( P = 0.005 ) , but not on the inappropriate speech subscale ( P = 0.20 ) than patients in the placebo group . Eleven patients in the riluzole group and five patients in the placebo group were classified as responders based on their CGI-I scores [ χ ( 2 ) ( 1 ) = 3.750 , P = 0.05 ] . Children in the riluzole group experienced significantly more increases in their appetite and bodyweight than children in the placebo group by the end of the study . CONCLUSION Riluzole add-on therapy shows several therapeutic outcomes , particularly for improving irritability , in children with autism . However , its add-on to risperidone also results in significantly increased appetite and weight gain .

Riluzole

risperidone

placebo-controlled

Riluzole

riluzole

irritability

neuropsychiatric disorders

efficacy and tolerability

ABC-C irritability subscale

ABC-C subscale scores

ABC-C irritability subscale

lethargy/social

stereotypic

hyperactivity/non-compliance

inappropriate

autistic disorders

irritability

autistic


Percutaneous coronary intervention in patients with previous coronary artery bypass grafting ( from the j-Cypher Registry ) . A paucity of data is available from large-scale studies evaluating the long-term outcomes of percutaneous coronary intervention in patients who had previously undergone coronary artery bypass grafting ( CABG ) in the drug-eluting stent era . Of 12,812 patients who had undergone sirolimus-eluting stent implantation in the j-Cypher registry , 919 ( 7.2 % ) had a history of CABG and had significantly higher crude 5-year mortality ( 19.9 % vs 14.0 % , p < 0.001 ) . After adjusting for confounders , the excess risk of death was no longer significant ( hazard ratio 0.99 , 95 % confidence interval 0.83 to 1.18 , p = 0.90 ) , and the adjusted risk of target lesion revascularization was significantly higher in patients with previous CABG than in those without ( hazard ratio 1.25 , 95 % confidence interval 1.06 to 1.47 , p = 0.01 ) . Of the patients with previous CABG , those who had undergone ≥1 saphenous vein graft intervention had significantly higher adjusted risks of cardiac death ( hazard ratio 2.21 , 95 % confidence interval 1.26 to 3.76 , p = 0.01 ) , myocardial infarction ( hazard ratio 2.56 , 95 % confidence interval 1.10 to 5.60 , p = 0.03 ) , target lesion revascularization ( hazard ratio 2.65 , 95 % confidence interval 1.82 to 3.81 , p < 0.001 ) , and definite stent thrombosis ( hazard ratio 7.70 , 95 % confidence interval 1.99 to 29.1 , p = 0.004 ) compared with those who underwent percutaneous coronary intervention only for the native coronary artery . In conclusion , the adjusted mortality was similar between patients with and without previous CABG , despite a significantly different risk of target lesion revascularization . Among the patients with previous CABG , those with saphenous vein graft intervention using a first-generation drug-eluting stent had worse clinical outcomes than those with a native coronary artery target only .

Percutaneous coronary intervention

percutaneous coronary intervention

crude 5-year mortality


Serum selenium concentration and antioxidant activity in cervical cancer patients before and after treatment . AIM In the present study , the effect of chemo and radio therapies on serum trace elements content and antioxidant activity in blood serum of cervical cancer patients was evaluated . METHODS Among 104 cervical cancer patients selected for the present study , 54 and 50 patients were treated with chemo- and radiotherapy respectively . Plasma Se , Zn , Cu and some enzymatic antioxidants activities were estimated in serum before and after the treatment . RESULTS The decreased levels of serum trace elements , glutathione peroxidase activity and total antioxidant capacity , and increased malondialdehyde , glutathion reductase was observed in cervical cancer patients when compared to healthy controls . The increased concentration of serum Se , Zn was observed in patients treated with chemotherapy . Simultaneously there was a significant ( P < 0.001 ) increase in glutathione peroxidase and total antioxidant capacity , and significant decrease ( P < 0.05 ) in malondialdehyde and glutathion reductase levels in the serum of patients treated with chemotherapy compared to the patients treated with radiotherapy . CONCLUSION The results demonstrated that chemotherapy but not radiotherapy results in significant increase in the trace elements levels and antioxidant activities in blood serum of cervical cancer patients .

selenium

chemo- and radiotherapy

chemotherapy

chemotherapy

radiotherapy

chemotherapy

radiotherapy

antioxidant activity

serum trace elements

malondialdehyde , glutathion reductase

concentration of serum Se , Zn

cervical cancer

cervical cancer

cervical cancer

cervical cancer

chemotherapy

cervical cancer


Comparison of enflurane and halothane in hypotensive eye surgery . Thirty patients undergoing elective eye surgery had anaesthesia induced with sodium thiopentone , suxamethonium and d-tubocurarine chloride . Patients were ventilated with nitrous oxide , oxygen and either halothane or enflurane . The volatile agents were used to decrease the systolic blood pressure to 80 mmHg . The volatile agent concentration in the blood was measured at 30 min intervals . Both agents were effective in producing hypotension , but enflurane was the more potent hypotensive agent in terms of MAC equivalents . There was no significant differences between the agents with respect to speed of recovery .

enflurane

halothane

sodium thiopentone

suxamethonium

d-tubocurarine chloride

nitrous oxide

oxygen

halothane

enflurane

systolic blood pressure

hypotension

speed of recovery

hypotensive eye surgery .

Thirty

elective eye surgery


Reputation management : evidence for ability but reduced propensity in autism . Previous research has reported that autistic adults do not manage their reputation , purportedly due to problems with theory of mind [ Izuma , Matsumoto , Camerer , & Adolphs ] . The current study aimed to test alternative explanations for this apparent lack of reputation management . Twenty typical and 19 autistic adults donated to charity and to a person , both when alone and when observed . In an additional manipulation , for half of the participants , the observer was also the recipient of their donations , and participants were told that this observer would subsequently have the opportunity to donate to them ( motivation condition ) . This manipulation was designed to encourage an expectation of a reciprocal " tit-for-tat " strategy in the participant , which may motivate participants to change their behavior to receive more donations . The remaining participants were told that the person watching was just observing the procedure ( no motivation condition ) . Our results replicated Izuma et al . 's finding that autistic adults did not donate more to charity when observed . Yet , in the motivation condition , both typical and autistic adults donated significantly more to the observer when watched , although this effect was significantly attenuated in autistic individuals . Results indicate that , while individuals with autism may have the ability to think about reputation , a reduced expectation of reciprocal behavior from others may reduce the degree to which they engage in reputation management .

test alternative explanations

donated to charity and to a person

donate

propensity

Matsumoto

Adolphs

tit-for-tat

Izuma


Contrast , motion , perceptual integration , and neurocognition in schizophrenia : the role of fragile-X related mechanisms . Recent studies demonstrated a reduced expression of Fragile X Mental Retardation Protein ( FMRP ) , an RNA binding protein and translation regulator , in the brain and peripheral lymphocytes of patients with schizophrenia . Low FMRP levels may be related to impaired neurodevelopmental processes and synaptic plasticity . Here , we studied the relationship between peripheral FMRP level , visual perception ( contrast sensitivity , perceptual integration , motion/form perception ) , and neuropsychological functions in schizophrenia as measured with the Repeatable Battery for the Assessment of Neuropsychological Status ( RBANS ) . Results revealed that patients with schizophrenia displayed lower FMRP levels in peripheral lymphocytes as compared to control individuals . We found significant correlations between FMRP levels and contrast sensitivity at low spatial and high temporal frequencies , perceptual integration , and motion perception . The relationship between FMRP level and neuropsychological functions was less pronounced than that seen in the case of visual perception , with the greatest effect for RBANS attention . FMRP level was not related to contrast sensitivity at high spatial and low temporal frequencies and form perception . This pattern of data is reminiscent to that observed in patients with Fragile X Syndrome ( FXS ) . These results suggest that FMRP may be implicated in the pathogenesis of schizophrenia , possibly via the regulation of neurodevelopment , plasticity , GABA-ergic , and glutamatergic neurotransmission .

FMRP levels

FMRP levels

FMRP level

neurodevelopment

plasticity

GABA-ergic

glutamatergic neurotransmission .

patients with schizophrenia

schizophrenia


The impact of parent-delivered intervention on parents of very young children with autism . This study investigated the impact of a parent-coaching intervention based on the Early Start Denver Model ( P-ESDM ) on parenting-related stress and sense of competence . This was part of a multisite , randomized trial comparing P-ESDM ( n = 49 ) with community intervention ( n = 49 ) for children aged 12 and 24 months . The P-ESDM group reported no increase in parenting stress , whereas the Community group experienced an increase over the same 3-month period . Parental sense of competence did not differ . Number of negative life events was a significant predictor of parenting stress and sense of competence across both groups . This suggests that a parent-coaching intervention may help maintain parental adjustment directly after a child is diagnosed with ASD .

parent-delivered intervention

parent-coaching intervention

Early Start Denver Model ( P-ESDM )

P-ESDM

parenting-related stress

sense of competence .

young children

autism

children aged 12 and 24 months


Total intravenous anesthesia using remifentanil in extracorporeal shock wave lithotripsy ( ESWL ) . Comparison of two dosages : a randomized clinical trial . BACKGROUND Extracorporeal Shock Wave Lithotripsy is usually performed in day surgery setting , consequently people who undergo to this procedure need a safe and fast recovery . Conscious sedation with remifentanil can relieve from pain and keep patients in touch with anaesthesiologists . Few publications tell about infusion rates administered to perform this procedure7 . The aim of this study is to assess which is the most appropriate infusion rate . METHODS Patients were randomly assigned to two groups . Two different infusion rates were compared : 0,05 mcg/kg/min , GROUP A ( N.=114 ) , vs. 0.1 µg/kg/min , GROUP B ( N.=114 ) . Patients ' vital signs , additional analgesic requests , PONV ( postoperative nausea and vomiting ) and other side effects were registered . The deepness of sedation and patient 's satisfaction were evaluated referring to Obsever 's Assessment of Alertness and Sedation scale ( O/ASS ) and using a Likert 's scale respectively . Pain intensity was assessed with a 11-points VAS ( visual analogue scale ) . Differences between groups were analyzed using Student t test for independent variables . The χ2 test was used to analyze categorical variables . RESULTS The study enrolled 228 patients and assigned them to two groups ( N.=114 ) . No significant differences were found regarding Likert 's scale values ( P=0.20 ) , additional analgesic request ( P=0.30 ) and mean VAS values ( P > 0.05 ) between the two groups . The difference between the two groups about PONV , hypotension , oxygen desaturation and respiratory depression was statistically significant ( P < 0.05 ) , as a matter of fact in group A these side effects occurred less frequently . The fifth degree of O/ASS was estimated in about 1.61±0.19 min and 2.987±0.20 min in group A and in group B respectively ( P < 0.05 ) . CONCLUSION According with previous results remifentanil at the infusion rate of 0.05 µg/kg/min provides an effective analgesia , causing a lower incidence of side effect than 0.1 µg/kg/min , granting a fast and safe recovery .

remifentanil

Extracorporeal Shock Wave Lithotripsy

remifentanil

Patients ' vital signs

additional analgesic requests

Pain intensity

regarding Likert 's scale values

mean VAS values

about PONV

The fifth degree of O/ASS