We tested the hypothesis that sleep training would improve emotional , social and behavioural functioning in children with attention-deficit/hyperactivity disorder ( ADHD ) compared to children with ADHD without such intervention and to healthy controls .


Forty children with ADHD were randomly assigned to intervention and control conditions .


Parents of 20 children with ADHD were instructed and thoroughly supervised in improving their children 's sleep schedules and sleep behaviour .


Parents of the other 20 children with ADHD and parents of 20 healthy children received general information about sleep hygiene .


At baseline and 12 weeks later , parents and children completed questionnaires related to children 's sleep and psychological functioning .


Relative to the control groups , children in the intervention group improved sleep quantitatively and qualitatively ( F values < 3.33 , P values < 0.05 ) .


The intervention group children reported improvements in mood , emotions , and relationships ( F values < 2.99 , P values < 0.05 ) .


Parents reported that their children improved in physical and psychological wellbeing , mood , emotions , relationships , and social acceptance ( F values < 3.02 , P values < 0.05 ) .


Training and monitoring parents of children with ADHD in regulating and supervising children 's sleep schedules leads to positive changes in the emotions , behaviour and social lives of these children .


To compare the impact of scheduling caesarean section prior to versus after 39 completed weeks of gestation on the occurrence of unscheduled caesarean section and rescheduling of the procedure .


Secondary analysis from a multicentre randomised open-label trial including singleton pregnant women with a healthy foetus and a reliable due date .


Women were allocated by computerized telephone randomisation to planned caesarean section at 38 weeks and three days or 39 weeks and three days .


The outcomes were unscheduled deliveries with provided reasons , such as spontaneous labour onset or supervening complications , and any changes in the scheduled delivery date .


Statistical analyses were according to intention-to-treat using Fisher 's exact test .


From March 2009 to June 2011 1,274 women were included .


Median difference in gestational age at delivery was six days .


Compared to the 38 weeks group , the women in the 39 weeks group were more likely to have an unscheduled caesarean section ( 15.2 % vs. 9.3 % ; RR 1.64 , 95 % CI 1.21 ; 2.22 ) , to deliver between 6 pm and 8 am ( 10 % vs. 6 % ; RR 1.68 , 95 % CI 1.14 ; 2.47 ) , or to have the procedure rescheduled ( 36.7 % vs. 23 % ; RR 1.6 , 95 % CI 1.34 ; 1.90 ) .


Scheduling caesarean section after 39 weeks leads to a 60 % increase in unscheduled caesarean sections and a 70 % increase in delivery outside regular work hours as compared to scheduling of the procedure prior to 39 weeks .


www.clinicaltrials.gov NCT00835003 http://www.clinicaltrials.gov/ct2/show/NCT00835003?term=NCT00835003&rank=1 .


We hypothesized that 4 days of normal daily activity after 21 days of experimental bed rest ( BR ) will not reverse BR induced impaired glucose tolerance .


Glucose tolerance of seven male , healthy , untrained test subjects ( age : 27.6 ( 3.3 ) years ( mean ( SD ) ) ; body mass : 78.6 ( 6.4 ) kg ; height : 1.81 ( 0.04 ) m ; VO2 max : 39.5 ( 5.4 ) ml/kg body mass/min ) was studied .


They stayed twice in the metabolic ward ( crossover design ) , 21 days in bed and 7 days before and after BR each .


Oral glucose tolerance tests were applied before , on day 21 of BR , and 5 and 14 days after BR .


On day 21 of BR , AUC ( 120min ) of glucose concentration was increased by 28.8 ( 5.2 ) % and AUC ( 120min ) of insulin by 35.9 ( 10.2 ) % ( glucose : P < 0.001 ; insulin : P = 0.02 ) .


Fourteen days after BR , AUC ( 120min ) of serum insulin concentrations returned to pre-bed-rest concentrations ( P = 0.352 ) and AUC ( 120min ) of glucose was still higher ( P = 0.038 ) .


Insulin resistance did not change , but sensitivity index was reduced during BR ( P = 0.005 ) .


Four days of light physical workload does not compensate inactivity induced impaired glucose tolerance .


An individually tailored and intensified training regime is mandatory in patients being in bed rest to get back to normal glucose metabolism in a reasonable time frame .


The purpose of this study was to investigate whether gentamicin irrigation solutions provide a potential new tool to prevent joint infection after arthroscopic ACL reconstruction .


In this prospective randomized study , 360 consecutive ACL recondition patients were randomized in two groups alternately from Feb 2008 to March 2012 .


In the first group , 180 patients underwent ACL reconstruction with a hamstring autograft , preoperative IV antibiotics , and normal saline ( 0.9 % sodium chloride ) solution .


In the second group 180 patients underwent ACL reconstruction with a hamstring autograft , preoperative IV antibiotics , and normal saline ( 0.9 % sodium chloride solution ) with added gentamicin ( 80 mg/L ) ( group 2 ) .


Three patients from group 1 and six patients from group 2 were excluded from the study due to loss of follow-up .


The patients were followed for 6 months and assessed for signs of deep infection .


In group 1 , a total of 4 ( 2.2 % ) postoperative septic arthritis cases were documented .


In group 2 , just one postoperative deep infection ( septic arthritis ) was documented ( 0.57 % ) .


Although the rate of septic arthritis in group 1 was higher than in group 2 , statistical analysis showed that the difference between using the gentamicin irrigation solution ( 80 mg/L ) and the saline solution alone was not significant .


Using gentamicin in irrigating solutions during arthroscopic ACL reconstruction surgery does not statistically decrease post operation septic arthritis .


Therapeutic Level II .


To evaluate the effect of sitagliptin in combination with metformin on glucose toxicity and lipotoxicity in patients with type 2 diabetes mellitus .


Eighty-two overweight and dyslipidemic patients ( mean age 55.3 + / - 9.1 years ) who had not achieved the goal levels of glycated hemoglobin ( HbA1c ) ( mean level 8.3 + / - 1.6 % ) during metformin therapy and dietotherapy were examined .


Group 1 patients received sitagliptin 100 mg/day in combination with metformin 2 g/day ; Group 2 took metformin 1.5-2 g/day .


The levels of fasting plasma glucose ( FPG ) levels , postprandial glycemia ( PPG ) , HbA1c , body weight , body mass index , waist circumference , and waist-to-hip ratio , blood lipid composition , and the levels of insulin , leptin , adiponectin , HOMA-IR , and HOMA-beta were estimated at baseline and 6 months later .


Visceral fat ( VF ) magnetic resonance imaging ( MRI ) was carried out .


Following 6 months , both groups showed positive changes in FPG , PPG , and HbA1c levels .


HbA1c decreased from 8.3 + / - 1.6 to 6.6 + / - 1.24 % in Group 1 and from 8.35 + / - 1.75 to 7.62 + / - 1.39 % in Group 2 .


PPG and FPG reduced by an average of 2.67 and 3.3 mmol/l in Group 1 and by 2.1 and 1.8 mmol/l in Group 2 .


HOMA-beta increased by 23.4 .


conventional units ( CU ) in Group 1 and by 4.8 CU in Group 2 .


HOMA-IR was noted to display positive changes in both groups .


The level of adiponectin rose by 1.9 ng/ml in Group 1 and by 0.49 % ng/ml in Group 2 and that of leptin fell by 7.37 and 1.21 ng/ml , respectively .


There were significant differences between the groups in anthropometric changes .


MRI revealed a significant VF drop by 20.6 + / - 13.5 cm2 ( 7.5 % ) in Group 1 and by 5.7 + / - 3.75 cm2 ( 1.76 % ) in Group 2 .


Combined therapy with sitagliptin and metformin caused reductions in glucose toxicity and lipotoxicity .


Genetic counseling for hereditary breast or colon cancer has implications for both counselees and their relatives .


Although counselees are encouraged by genetic counselors to disclose genetic cancer risk information , they do not always share this information with their at-risk relatives .


Reasons for not informing relatives may be generally categorized as a lack of knowledge , motivation and/or self-efficacy .


Presented here is the protocol of a randomized controlled trial that aims to establish the effectiveness of an intervention focused on supporting counselees in their disclosure of genetic cancer information to their relatives .


A multicenter randomized controlled trial with parallel group design will be used to compare the effects of an additional telephone counseling session performed by psychosocial workers to enhance the disclosure of genetic cancer information to at-risk relatives ( intervention group ) with a control group of standard care .


Consecutive index patients with relatives at risk for hereditary or familial breast and/or ovarian cancer or colon cancer , are randomly assigned ( block size : 8 ; 1:1 allocation ratio ) to the intervention ( n = 132 ) or control group ( n = 132 , standard care ) .


Primary outcomes are counselees ' knowledge , motivation and self-efficacy regarding informing their relatives .


This intervention may prove important in supporting counselees to disclose hereditary and/or familial cancer risk information to at-risk relatives and may enable more at-risk relatives to make a well-informed decision regarding genetic services and/or screening .


This trial is registered in the Netherlands National Trial Register ( NTR ) with trial ID number NTR3745 .


We have previously shown the prognostic importance of tumor-infiltrating lymphocytes ( TILs ) in newly diagnosed triple-negative breast cancer ( TNBC ) using tumor samples from a large clinical trial cohort .


In this study , we aimed to validate these findings and also investigate associations with trastuzumab benefit in HER2-overexpressing disease ( HER2 + ) .


A prospective-retrospective study was conducted using samples from the FinHER adjuvant , phase III trial that enrolled 1010 early-stage BC patients , 778 of whom were HER2-nonamplified .


Those with HER2 + disease ( n = 232 ) were randomized to 9 weeks of trastuzumab or no trastuzumab in addition to chemotherapy .


Two pathologists independently quantified stromal TILs in 935 ( 92.6 % ) available slides .


The primary end point of distant disease-free survival ( DDFS ) and interactions with trastuzumab were studied in Cox regression models .


Confirming our previous findings , in TNBC ( n = 134 ) each 10 % increase in TILs was significantly associated with decreased distant recurrence in TNBC ; for DDFS the hazard ratio adjusted for clinicopathological factors : 0.77 ; 95 % confidence interval ( CI ) 0.61-0 .98 , P = 0.02 .


In HER2 + BC ( n = 209 ) , each 10 % increase in lymphocytic infiltration was significantly associated with decreased distant recurrence in patients randomized to the trastuzumab arm ( DDFS P interaction = 0.025 ) .


Higher levels of TILs present at diagnosis were significantly associated with decreased distant recurrence rates in primary TNBC .


These results confirm our previous data and further support that TILs should be considered as a robust prognostic factor in this BC subtype .


We also report for the first time an association between higher levels of TILs and increased trastuzumab benefit in HER2 + disease .


Further research into why some TN and HER2 + BCs can or can not generate a host antitumor immune response and how trastuzumab can favorably alter the immune microenvironment is warranted .


We aimed to assess the impact of spin ( ie , reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results ) on the interpretation of results of abstracts of randomized controlled trials ( RCTs ) in the field of cancer .


We performed a two-arm , parallel-group RCT .


We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion .


Two versions of these abstracts were used-the original with spin and a rewritten version without spin .


Participants were clinician corresponding authors of articles reporting RCTs , investigators of trials , and reviewers of French national grants .


The primary outcome was clinicians ' interpretation of the beneficial effect of the experimental treatment ( 0 to 10 scale ) .


Participants were blinded to study hypothesis .


Three hundred clinicians were randomly assigned using a Web-based system ; 150 clinicians assessed an abstract with spin and 150 assessed an abstract without spin .


For abstracts with spin , the experimental treatment was rated as being more beneficial ( mean difference , 0.71 ; 95 % CI , 0.07 to 1.35 ; P = .030 ) , the trial was rated as being less rigorous ( mean difference , -0.59 ; 95 % CI , -1.13 to 0.05 ; P = .034 ) , and clinicians were more interested in reading the full-text article ( mean difference , 0.77 ; 95 % CI , 0.08 to 1.47 ; P = .029 ) .


There was no statistically significant difference in the clinicians ' rating of the importance of the study or the need to run another trial .


Spin in abstracts can have an impact on clinicians ' interpretation of the trial results .


Globally , herpes simplex virus type 2 ( HSV-2 ) infection is the most common cause of genital ulcer disease .


Effective prevention strategies for HSV-2 infection are needed to achieve the goals of the World Health Organization global strategy for the prevention and control of sexually transmitted infections .


We assessed the effectiveness of pericoital tenofovir gel , an antiviral microbicide , in preventing HSV-2 acquisition in a subgroup of 422 HSV-2-negative women enrolled in the Centre for the AIDS Programme of Research in South Africa ( CAPRISA ) 004 study , a double-blind , randomized , placebo-controlled trial .


Incident HSV-2 cases were identified by evidence of seroconversion on an HSV-2 IgG enzyme-linked immunosorbent assay between study enrollment and exit .


A confirmatory analysis was performed by Western blot testing .


The HSV-2 incidence rate was 10.2 cases per 100 person-years ( 95 % confidence interval [ CI ] , 6.8 to 14.7 ) among 202 women assigned to tenofovir gel , as compared with 21.0 cases per 100 person-years ( 95 % CI , 16.0 to 27.2 ) among 222 women assigned to placebo gel ( incidence rate ratio , 0.49 ; 95 % CI , 0.30 to 0.77 ; P = 0.003 ) .


The HSV-2 incidence rate among the 25 women with vaginal tenofovir concentrations of 10,000 ng per milliliter or more was 5.7 cases per 100 person-years , as compared with 15.5 cases per 100 person-years among the 103 women with no detectable vaginal tenofovir ( incidence rate ratio , 0.37 ; 95 % CI , 0.04 to 1.51 ; P = 0.14 ) .


As confirmed by Western blot testing , there were 16 HSV-2 seroconversions among women assigned to tenofovir gel as compared with 36 among those assigned to the placebo gel ( incidence rate ratio , 0.45 ; 95 % CI , 0.23 to 0.82 ; P = 0.005 ) .


In this study in South Africa , pericoital application of tenofovir gel reduced HSV-2 acquisition in women .


( Funded by the U.S. Agency for International Development and others ; ClinicalTrials.gov number , NCT00441298 . )


The implementation of a complex intervention is heavily influenced by individual context .


Variation in implementation and tailoring of the intervention to the particular context will occur , even in a trial setting .


It is recognised that in trials , evaluating the process of implementation of a complex intervention is important , yet process evaluation methods are rarely reported .


The WAVES study is a cluster randomised controlled trial to evaluate the effectiveness of an obesity prevention intervention programme targeting children aged 6-7 years , delivered by teachers in primary schools across the West Midlands , UK .


The intervention promoted activities encouraging physical activity and healthy eating .


This paper presents the methods used to assess implementation of the intervention .


Previous literature was used to identify the dimensions of intervention process and implementation to be assessed , including adherence , exposure , quality of delivery , participant responsiveness , context , and programme differentiation .


Multiple methods and tools were developed to capture information on all these dimensions .


These included observations , logbooks , qualitative evaluation , questionnaires and research team reflection .


Data collection posed several challenges , predominantly when relying on teachers to complete paperwork , which they saw as burdensome on top of their teaching responsibilities .


However , the use of multiple methods helped to ensure data on each dimension , where possible , was collected using more than one method .


This also allowed for triangulation of the findings when several data sources on any one dimension were available .


We have reported a comprehensive approach to the assessment of the implementation and processes of a complex childhood obesity prevention intervention within a cluster randomised controlled trial .


These approaches can be transferred and adapted for use in other complex intervention trials .


ISRCTN97000586 .


Low-cost interventions to improve cancer screening among primary care patients are needed .


The comparative effectiveness of personalized letters , automated telephone calls , and both on breast cancer ( BC ) and colorectal cancer ( CRC ) screening is not known .


A pragmatic , randomized , controlled trial was conducted in 2011 to 2012 .


Eligible primary care patients were women ages 50 to 74 years who were past due for mammography and men or women who were past due for mammography or CRC screening of any kind ( > 12 months since last fecal occult blood test , > 5 years since last sigmoidoscopy/double-contrast barium enema , or > 10 years since last colonoscopy ) , respectively .


Participants were randomized to 1 of 3 interventions : personalized mailed letters , automated telephone calls , or both .


The primary outcome was medical record documentation of a completed mammogram or CRC screening within 36 weeks of randomization .


We estimated the costs of each intervention and calculated the marginal cost-effectiveness per person screened .


The crude screening rates for BC were 19 % , 22 % , and 37 % and for CRC were 17 % , 14 % , and 24 % for the letter , automated call , and combined ( letter/automated call ) groups , respectively .


The combined intervention group had a statistically higher screening rate ( P < .05 ) compared with either of the single intervention groups ( letter only or automated call ) for both BC and CRC in both the crude and adjusted analyses .


The combined intervention costs $ 5.11 per additional person screened for BC and $ 13.14 per additional person screened for CRC .


In a primary care practice , letters plus automated telephone calls are better than either alone in increasing cancer screening rates among patients who are overdue for screening .


These findings suggest the promise of a relatively inexpensive intervention to improve cancer screening .


Graphic warnings ( GWs ) on cigarette packs are widely used internationally and perhaps will be in the US but their impact is not well understood .


This study tested support for competing hypotheses in different subgroups of young adults defined by their history of cigarette smoking and individual difference variables ( e.g. , psychological reactance ) .


One hypothesis predicted adaptive responding ( GWs would lower smoking-related intentions ) and another predicted defensive responding ( GWs would raise smoking-related intentions ) .


Participants were an online sample of 1,169 Americans ages 18-24 , who were randomly assigned either to view nine GWs designed by the FDA or to a no-label control .


Both the intention to smoke in the future and the intention to quit smoking ( among smokers ) were assessed before and after message exposure .


GWs lowered intention to smoke in the future among those with a moderate lifetime smoking history ( between 1 and 100 cigarettes ) , and they increased intention to quit smoking among those with a heavy lifetime smoking history ( more than 100 cigarettes ) .


Both effects were limited to individuals who had smoked in some but not all of the prior 30 days ( i.e. , occasional smokers ) .


No evidence of defensive `` boomerang effects '' on intention was observed in any subgroup .


Graphic warnings can reduce interest in smoking among occasional smokers , a finding that supports the adaptive-change hypothesis .


GWs that target occasional smokers might be more effective at reducing cigarette smoking in young adults .


Little is known about diet quality with a reduced-energy , low-fat , partial meal replacement plan , especially in individuals with type 2 diabetes .


The Action for Health in Diabetes ( Look AHEAD ) trial implemented a partial meal replacement plan in the Intensive Lifestyle Intervention .


To compare dietary intake and percent meeting fat-related and food group dietary recommendations in Intensive Lifestyle Intervention and Diabetes Support and Education groups at 12 months .


A randomized controlled trial comparing Intensive Lifestyle Intervention with Diabetes Support and Education at 0 and 12 months .


From 16 US sites , the first 50 % of participants ( aged 45 to 76 years , overweight or obese , with type 2 diabetes ) were invited to complete dietary assessments .


Complete 0 - and 12-month dietary assessments ( collected between 2001 and 2004 ) were available for 2,397 participants ( 46.6 % of total participants ) , with 1,186 randomized to Diabetes Support and Education group and 1,211 randomized to Intensive Lifestyle Intervention group .


A food frequency questionnaire assessed intake : energy ; percent energy from protein , fat , carbohydrate , polyunsaturated fatty acids , and saturated fats ; trans-fatty acids ; cholesterol ; fiber ; weekly meal replacements ; and daily servings from food groups from the Food Guide Pyramid .


Mixed-factor analyses of covariance , using Proc MIXED with a repeated statement , with age , sex , race/ethnicity , education , and income controlled .


Unadjusted tests compared percent meeting fat-related and food group recommendations at 12 months .


At 12 months , Intensive Lifestyle Intervention participants had a significantly lower fat and cholesterol intake and greater fiber intake than Diabetes Support and Education participants .


Intensive Lifestyle Intervention participants consumed more servings per day of fruits ; vegetables ; and milk , yogurt , and cheese ; and fewer servings per day of fats , oils , and sweets than Diabetes Support and Education participants .


A greater percentage of Intensive Lifestyle Intervention participants than Diabetes Support and Education participants met fat-related and most food group recommendations .


Within Intensive Lifestyle Intervention , a greater percentage of participants consuming two or more meal replacements per day than participants consuming less than one meal replacement per day met most fat-related and food group recommendations .


The partial meal replacement plan consumed by Intensive Lifestyle Intervention participants was related to superior diet quality .


Apolioprotein E ( APOE ) genotype is reported to influence a person 's fasting lipid profile and potentially the response to dietary fat manipulation .


The impact of APOE genotype on the responsiveness to meals of varying fat composition is unknown .


We examined the effect of meals containing 50 g of fat rich in saturated fatty acids ( SFAs ) , unsaturated fatty acids ( UNSATs ) , or SFAs with fish oil ( SFA-FO ) on postprandial lipemia .


A randomized , controlled , test meal study was performed in men recruited according to the APOE genotype ( n = 10 APOE3/3 , n = 11 APOE3/E4 ) .


For the serum apoE response ( meal genotype interaction P = 0.038 ) , concentrations were on average 8 % lower after the UNSAT than the SFA-FO meal in APOE4 carriers ( P = 0.015 ) only .


In the genotype groups combined , there was a delay in the time to reach maximum triacylglycerol ( TG ) concentration ( mean SEM : 313 25 vs. 266 27 min ) and higher maximum nonesterified fatty acid ( 0.73 0.05 vs. 0.60 0.03 mmol/L ) and glucose ( 7.92 0.22 vs. 7.25 0.22 mmol/L ) concentrations after the SFA than the UNSAT meal , respectively ( P 0.05 ) .


In the Svedberg flotation rate 60-400 TG-rich lipoprotein fraction , meal genotype interactions were observed for incremental area under the curve ( IAUC ) for the TG ( P = 0.038 ) and apoE ( P = 0.016 ) responses with a 58 % lower apoE IAUC after the UNSAT than the SFA meal ( P = 0.017 ) in the E4 carriers .


Our data indicate that APOE genotype had a modest impact on the postprandial response to meals of varying fat composition in normolipidemic men .


The physiologic importance of greater apoE concentrations after the SFA-rich meals in APOE4 carriers may reflect an impact on TG-rich lipoprotein clearance from the circulation .


This trial was registered at clinicaltrials.gov as NCT01522482 .


In obese women , 1 ) to assess whether lower gestational weight gain ( GWG ) during pregnancy in the lifestyle intervention group of a randomized controlled trial ( RCT ) resulted in differences in offspring anthropometrics and body composition , and 2 ) to compare offspring outcomes to a reference group of children born to women with a normal Body Mass Index ( BMI ) .


The LiPO ( Lifestyle in Pregnancy and Offspring ) study was an offspring follow-up of a RCT with 360 obese pregnant women with a lifestyle intervention during pregnancy including dietary advice , coaching and exercise .


The trial was completed by 301 women who were eligible for follow-up .


In addition , to the children from the RCT , a group of children born to women with a normal BMI were included as a reference group .


At 2.8 ( range 2.5-3 .2 ) years , anthropometrics were measured in 157 children of the RCT mothers and in 97 reference group children with Body Mass Index ( BMI ) Z-score as a primary outcome .


Body composition was estimated by Dual Energy X-ray ( DEXA ) in 123 successful scans out of 147 ( 84 % ) .


No differences between randomized groups were seen in mean ( 95 % C.I. ) BMI Z-score ( intervention group 0.06 [ -0.17 ; 0.29 ] vs. controls -0.18 [ -0.43 ; 0.05 ] ) , in the percentage of overweight or obese children ( 10.9 % vs. 6.7 % ) , in other anthropometrics , or in body composition values by DEXA .


Outcomes between children from the RCT and the reference group children were not significantly different .


The RCT with lifestyle intervention in obese pregnant women did not result in any detectable effect on offspring anthropometrics or body composition by DEXA at 2.8 years of age .


This may reflect the limited difference in GWG between intervention and control groups .


Offspring of obese mothers from the RCT were comparable to offspring of mothers with a normal BMI .


In the past 50 years , individual patient involvement at the clinical consultation level has received considerable attention .


More recently , patients and the public have increasingly been involved in collective decisions concerning the improvement of health care and policymaking .


However , rigorous evaluation guiding the development and implementation of effective public involvement interventions is lacking .


This article describes those key ingredients likely to affect public members ' ability to deliberate productively with professionals and influence collective health care choices .


We conducted a trial process evaluation of public involvement in setting priorities for health care improvement .


In all , 172 participants ( including 83 patients and public members and 89 professionals ) from 6 Health and Social Services Centers in Canada participated in the trial .


We video-recorded 14 one-day meetings , and 2 nonparticipant observers took structured notes .


Using qualitative analysis , we show how public members influenced health care improvement priorities .


Legitimacy , credibility , and power explain the variations in the public members ' influence .


Their credibility was supported by their personal experience as patients and caregivers , the provision of a structured preparation meeting , and access to population-based data from their community .


Legitimacy was fostered by the recruitment of a balanced group of participants and by the public members ' opportunities to draw from one another 's experience .


The combination of small-group deliberations , wider public consultation , and a moderation style focused on effective group process helped level out the power differences between professionals and the public .


The engagement of key stakeholders in the intervention design and implementation helped build policy support for public involvement .


A number of interacting active ingredients structure and foster the public 's legitimacy , credibility , and power .


By paying greater attention to them , policymakers could develop and implement more effective public involvement interventions .


Observational studies show that when a depressed mother 's symptoms remit , her children 's psychiatric symptoms decrease .


Using randomized treatment assignment , the authors sought to determine the differential effects of a depressed mother 's treatment on her child .


The study was a randomized double-blind 12-week trial of escitalopram , bupropion , or the combination of the two in depressed mothers ( N = 76 ) , with independent assessment of their children ( N = 135 ; ages 7-17 years ) .


There were no significant treatment differences in mothers ' depressive symptoms or remission .


Children 's depressive symptoms and functioning improved significantly among those whose mothers were in the escitalopram group ( compared with those whose mothers were in the bupropion and combination treatment groups ) .


Only in the escitalopram group was significant improvement of mother 's depression associated with improvement in the child 's symptoms .


Exploratory analyses suggested that this may be due to changes in parental functioning : Mothers in the escitalopram group reported significantly greater improvement , compared with the other groups , in their ability to listen and talk to their children , who as a group reported that their mothers were more caring over the 12 weeks .


Maternal baseline negative affectivity appeared to moderate the effect of maternal treatment on children , although the effect was not statistically significant .


Children of mothers with low negative affectivity improved in all treatment groups .


Children of mothers with high negative affectivity improved significantly only for those whose mothers were in the escitalopram group .


The effects of the depressed mother 's improvement on her children may depend on her type of treatment .


Depressed mothers with high anxious distress and irritability may require medications that reduce these symptoms in order to show the effect of her remission on her children .


To systematically test the cumulative effect of the M Technique on infant neurodevelopment in hospitalized very preterm infants .


A pilot randomized controlled trial ( RCT ) .


Twenty very preterm infants ( < 30 weeks gestation with average birth weights < 1000 g ) were randomly assigned to nontreatment or treatment groups .


The study period began once the infants reached 30 weeks postmenstrual age ( PMA ) .


Each infant received standard neonatal intensive unit ( NICU ) care or standard NICU care plus a 7-minute M Technique session , 6 times per week for 5 weeks .


Neurobehavioral development ( using the NICU Network Neurobehavioral Scale [ NNNS ] ) and growth velocity ( difference in infant weight at the beginning and end of protocol ) were compared between the 2 groups .


Physiologic parameters ( heart rate , respiratory rate , and oxygen saturations ) and infant behavioral states were measured 5 minutes before , during , and up to 10 minutes postintervention continuously on all infants in the treatment group at 3 different gestational time points ( 30 , 32 , and 34 weeks PMA ) over the 5-week period .


Mann-Whitney U analyses revealed no differences between the 2 groups on all 12 NNNS summary score domains but a difference in growth velocity between the 2 groups ( P = 0.005 ) .


Repeated-measures analysis of variance revealed significant physiologic differences of mean heart rate , respiratory rate , and SaO2 ( F = 41.116 , P < 0.0005 ) and behavioral states ( F = 38.564 , P < 0.0005 ) from baseline to 10 minutes after the M Technique intervention across all 3 time points .


State scores decreased from baseline ( M = 6.11 ) to post intervention ( M = 1.4 ) at all 3 time points .


This pilot RCT demonstrates the utility of the M Technique in hospitalized very preterm infants starting at 30 weeks PMA with notable evidence of positive weight , physiological , and behavioral state adaptations .


Additional research is needed with a larger , randomized design to determine short - and long-term effects specifically related to neurological outcomes .


Two phase I , single-blind ( subject blinded to treatment ) , randomized studies were conducted to assess the pharmacodynamics , pharmacokinetics , safety , and tolerability of lipegfilgrastim compared with pegfilgrastim in healthy adult volunteers .


Study 1 consisted of a pilot safety phase ( N = 8 ) during which subjects received a single body-weight-adjusted subcutaneous dose of lipegfilgrastim 25 g/kg and a dose escalation phase ( N = 45 ) wherein subjects received lipegfilgrastim 50 or 100 g/kg or pegfilgrastim 100 g/kg .


Study 2 was a single-blind , fixed-dose study ( N = 36 ) comparing subcutaneous lipegfilgrastim 6 mg and pegfilgrastim 6 mg .


Cumulative exposure ( AUC0-t last and AUC 0 - ) and peak exposure ( Cmax ) were higher for lipegfilgrastim than pegfilgrastim after both weight-adjusted and fixed dosing .


In both studies , the terminal elimination half-life of lipegfilgrastim was 5-10 hours longer than the terminal elimination half-life for pegfilgrastim at the maximum dose , and the time to maximum serum concentration ( tmax ) was observed later for lipegfilgrastim than for pegfilgrastim .


The area over the baseline effect curve ( AOBEC ) for absolute neutrophil count ( ANC ) was approximately 30 % greater after lipegfilgrastim dosing compared with the same dose of pegfilgrastim at the maximum dose .


Both drugs were well tolerated , with a similar occurrence of adverse events between treatment groups .


Key limitations of these studies include the small numbers of subjects and differences in dosage regimens between the two studies .


In these studies , lipegfilgrastim provided a longer-lasting increase in ANC compared with pegfilgrastim at an equivalent dose , without increasing the peak ANC values .


This may reflect the higher cumulative exposure and slower clearance ( therefore longer body residence ) of lipegfilgrastim .


These data support the use of single-dose lipegfilgrastim 6 mg in subsequent phase III trials as prophylactic treatment for patients receiving myelosuppressive chemotherapy .


To determine whether changes in theory of planned behaviour ( TPB ) constructs could predict intention and gluten-free diet ( GFD ) adherence following participation in an online theory-based intervention designed to improve adherence in coeliac disease .


Theory-based process evaluation of the mechanisms of change over the course of a six-week online intervention .


Measures of GFD adherence and TPB variables were administered at baseline and follow-up ( immediate post-intervention : n = 74 ; three-month : n = 68 ; six-month : n = 65 ) .


Hierarchical regression analyses using residualised change scores were conducted at each time point ( dependent variables : intention and adherence ) .


Baseline intention and GFD adherence were the strongest predictors of follow-up intention and adherence , respectively .


Change in attitude accounted for significant variance in intention .


Change in intention accounted for significant variance in GFD adherence immediately post-intervention ; by the six-month follow-up change in perceived behavioural control was the stronger predictor .


Partial support for the hypotheses suggests that , for certain behaviours , the TPB may be relevant in explaining the mechanism of action responsible for changes in intention and behaviour following participation in a behaviour change intervention .


Additional predictive pathways are also likely to exist and , in the area of GFD adherence , may include habit strength and actual behavioural control .


Cooling the pharynx and upper oesophagus would be more advantageous for rapid induction of therapeutic hypothermia since the carotid arteries run in their vicinity .


The aim of this study was to determine the effects of pharyngeal cooling on brain temperature and the safety and feasibility for patients under resuscitation .


Witnessed non-traumatic cardiac arrest patients ( n = 108 ) were randomized to receive standard care with ( n = 53 ) or without pharyngeal cooling ( n = 55 ) .


In the emergency room , pharyngeal cooling was initiated before or shortly after return of spontaneous circulation by perfusing physiological saline ( 5 C ) into a pharyngeal cuff for 120 min .


There was a significant decrease in tympanic temperature at 40 min after arrival ( P = 0.02 ) with a maximum difference between the groups at 120 min ( 32.9 1.2 C , pharyngeal cooling group vs. 34.1 1.3 C , control group ; P < 0.001 ) .


The return of spontaneous circulation ( 70 % vs. 65 % , P = 0.63 ) and rearrest ( 38 % vs. 47 % , P = 0.45 ) rates were not significantly different based on the initiation of pharyngeal cooling .


No post-treatment mechanical or cold-related injury was observed on the pharyngeal epithelium by macroscopic observation .


The thrombocytopaenia incidence was lower in the pharyngeal cooling group ( P = 0.001 ) during the 3-day period after arrival .


The cumulative survival rate at 1 month was not significantly different between the two groups .


Initiation of pharyngeal cooling before or immediately after the return of spontaneous circulation is safe and feasible .


Pharyngeal cooling can rapidly decrease tympanic temperature without adverse effects on circulation or the pharyngeal epithelium .


Tracheal intubation is one of the strongest stimuli during general anaesthesia and may result in an insufficient depth of anaesthesia .


The aim of the study was to compare the clinical evaluation of the depth of anaesthesia with an evaluation using entropy during inhalational and intravenous induction of general anaesthesia .


This study involved 60 patients undergoing elective surgery under general anaesthesia .


Patients were divided into two groups , group E ( etomidate induction ) and group S ( sevoflurane induction ) .


The systolic arterial pressure ( SAP ) , heart rate ( HR ) , response entropy ( RE ) , and state entropy ( SE ) were determined at the following seven measurement points : before anaesthesia induction , at the loss of consciousness ( LOC ) point , before tracheal intubation , immediately after intubation , and 2 min. , 4 min .


and 6 min .


after tracheal intubation .


An increase in HR and/or SAP of more than 20 % and/or the occurrence of lacrimation and/or perspiration in response to tracheal intubation was considered a marker of inadequate anaesthesia in the clinical evaluation .


The depth of anaesthesia was considered insufficient according to entropy monitoring if the RE and SE were above 60 .


In clinical evaluation , insufficient anaesthesia in response to tracheal intubation was observed in all the patients in group E and in more than half of the patients in group S.


At the same time , the majority of patients in both groups had entropy values that did not exceed the recommended value as an appropriate level of anaesthesia .


We found a discrepancy in the evaluation of the depth of anaesthesia based on clinical criteria compared with evaluations based on entropy values during both intravenous and inhalational induction of general anaesthesia .


Current treatment of ischaemic stroke with thrombolytic therapy is restricted to 3-45 h after symptom onset .


We aimed to assess the safety and efficacy of desmoteplase , a fibrin-dependent plasminogen activator , given between 3 h and 9 h after symptom onset in patients with occlusion or high-grade stenosis in major cerebral arteries .


In a prospective , double-blind , multicentre , parallel-group , randomised trial , we enrolled patients from 77 hospitals in 17 countries who had ischaemic stroke and occlusion or high-grade stenosis in major cerebral arteries .


We randomly assigned patients in a 1:1 ratio , using computer-generated randomisation lists with stratification for baseline National Institutes of Health Stroke Scale and age , to treatment with desmoteplase ( 90 g/kg ) given 3-9 h after symptom onset or to placebo .


Patients , investigators , staff , and the funder were masked to treatment assignment .


The primary outcome was a favourable modified Rankin Scale score ( 0-2 ) at day 90 in all treated patients who had at least one postbaseline measurement of the modified Rankin Scale .


Safety was assessed in all randomly assigned patients who received study drugs .


This trial is registered with ClinicalTrials.gov , number NCT00790920 .


Between Feb 6 , 2009 , and Nov 27 , 2013 , we enrolled 492 patients and randomly assigned 247 to desmoteplase and 245 to placebo ( 236 in the desmoteplase group and 237 in the placebo group were included in the analysis of the primary endpoint ) .


Median time from stroke onset to treatment was 69 h ( IQR 57-80 ) for placebo and 70 h ( 60-79 ) for desmoteplase .


Modified Rankin Scale score ( 0-2 ) at day 90 occurred in 121 ( 51 % ) patients given desmoteplase and 118 ( 50 % ) patients given placebo ( adjusted odds ratio 120 , 95 % CI 079-181 , p = 040 ) .


24 ( 10 % ) of 240 patients given desmoteplase died compared with 23 ( 10 % ) of 238 patients given placebo .


Serious adverse events occurred in 64 ( 27 % ) of 240 patients receiving desmoteplase compared with 69 ( 29 % ) of 238 patients receiving placebo ; frequency of symptomatic intracranial haemorrhage ( six [ 3 % ] patients in the desmoteplase group vs five [ 2 % ] in the placebo group ) , symptomatic cerebral oedema ( five [ 2 % ] vs four [ 2 % ] ) , and major haemorrhage ( ten [ 4 % ] vs 15 [ 6 % ] ) was much the same between treatment groups .


Treatment with desmoteplase did not cause safety concerns and did not improve functional outcome when given to patients who had ischaemic stroke and major cerebral artery occlusion beyond 3 h of symptom onset .


H Lundbeck A/S .


Beneficial effects of dietary supplements in age-related macular degeneration ( AMD ) are related to antioxidative properties .


In the Age-Related Eye Disease Study 1 ( AREDS 1 ) , a reduced progression to late stage AMD was found using vitamin C , E , zinc , and - carotene .


We showed previously that the AREDS 1 formulation restores the O2-induced retinal vasoconstrictor response of retinal vessels in a human endotoxin ( lipopolysaccharide [ LPS ] ) model .


We hypothesized that the abnormal O2-induced retinal red blood cell ( RBC ) flow response can be modulated by a different formulation ( vitamin C , E , and zinc , lutein/zeaxanthin , selenium , taurine , Aronia extract , and omega-3 free fatty acids ) .


A total of 43 healthy subjects was included in this randomized , double masked , placebo-controlled parallel group study .


The reactivity of retinal arterial and venous diameter , RBC velocity , and flow to 100 % O2 breathing was investigated in the absence and presence of 2 ng/kg LPS .


Between the two study days was a 14-day period of daily dietary supplement intake .


The decrease in retinal arterial diameter , RBC velocity , and flow during 100 % O2 breathing was diminished significantly after LPS infusion .


Dietary supplement intake for 14 days almost restored the response of retinal hemodynamic parameters to 100 % O2 after LPS administration .


This effect was significant for retinal arterial diameter ( P = 0.03 between groups ) , and RBC velocity and flow ( each P < 0.01 between groups ) .


The present data indicate restoring of the RBC flow response to 100 % O2 after LPS administration .


This is likely due to an amelioration of endothelial dysfunction resulting from oxidative stress , a factor involved in AMD pathophysiology .


( ClinicalTrials.gov number , NCT00914576 . )


To compare the performance and effectiveness of a hydrocolloid dressing ( HD ) and a transparent polyurethane film ( PF ) in preventing pressure ulcer ( PU ) development .


The study was conducted in the intensive care unit , coronary care unit and medical clinic of the Holy House of Mercy of Passos , Brazil .


Data were collected 48 hours after admission and during hospitalisation .


The Braden scale was used for PU risk assessment .


Consecutive eligible patients without PUs were randomly assigned by lottery to the two groups , either the HD or PF group .


Of the 160 eligible patients , significant between-group differences were found in the mean total number of dressing changes ( HD , 6.091.655 changes ; PF , 5.592.036 changes ; p = 0.010 ) , and mean number of dressing changes in the sacral region ( HD , 2.500.871 ; PF , 2.050.825 ; p = 0.001 ) , with the PF group requiring significantly fewer changes than the HD group .


The most common reasons for changing dressings in both groups were moisture ( PF 51.1 % ; HD 47.9 % ) and shear ( HD 43 % ; PF 38.9 % ) , with a significant difference in shear between groups .


The incidence of PUs was significantly lower ( p = 0.038 ) in the PF group ( 8.7 % ) compared with that in the HD group ( 15 % ) .


The results suggest that the transparent polyurethane film had a better performance and was more effective than the hydrocolloid dressing in preventing PU development .


To evaluate Bacille Calmette-Gurin ( BCG ) effects after clinically isolated syndromes ( CIS ) .


In a double-blind , placebo-controlled trial , participants were randomly assigned to receive BCG or placebo and monitored monthly with brain MRI ( 6 scans ) .


Both groups then entered a preplanned phase with IM interferon -- 1a for 12 months .


From month 18 onward , the patients took the disease-modifying therapies ( DMTs ) that their neurologist considered indicated in an open-label extension phase lasting up to 60 months .


Of 82 randomized subjects , 73 completed the study ( 33 vaccinated and 40 placebo ) .


During the initial 6 months , the number of cumulative lesions was significantly lower in vaccinated people .


The relative risks were 0.541 ( 95 % confidence interval [ CI ] 0.308-0 .956 ; p = 0.03 ) for gadolinium-enhancing lesions ( the primary endpoint ) , 0.364 ( 95 % CI 0.207-0 .639 ; p = 0.001 ) for new and enlarging T2-hyperintense lesions , and 0.149 ( 95 % CI 0.046-0 .416 ; p = 0.001 ) for new T1-hypointense lesions .


The number of total T1-hypointense lesions was lower in the BCG group at months 6 , 12 , and 18 : mean changes from baseline were -0.09 0.72 vs 0.75 1.81 ( p = 0.01 ) , 0.0 0.83 vs 0.88 2.21 ( p = 0.08 ) , and -0.21 1.03 vs 1.00 2.49 ( p = 0.02 ) .


After 60 months , the cumulative probability of clinically definite multiple sclerosis was lower in the BCG + DMT arm ( hazard ratio = 0.52 , 95 % CI 0.27-0 .99 ; p < 0.05 ) , and more vaccinated people remained DMT-free ( odds ratio = 0.20 , 95 % CI 0.04-0 .93 ; p = 0.04 ) .


Early BCG may benefit CIS and affect its long-term course .


BCG , as compared to placebo , was associated with significantly reduced development of gadolinium-enhancing lesions in people with CIS for a 6-month period before starting immunomodulating therapy ( Class I evidence ) .


To systematically investigate chemotherapy versus chemotherapy followed by involved field radiotherapy for limited-stage aggressive non-Hodgkin 's lymphoma .


A systematic literature search of Pubmed , EMBASE , and the Cochrane central register of controlled trials was performed .


Data from all randomized controlled trials comparing chemotherapy alone with chemotherapy followed by involved field radiotherapy in patients with limited-stage aggressive non-Hodgkin 's lymphoma was collaborate .


The primary outcome was overall survival ; secondary outcomes were event-free survival and cumulative incidences of toxicity .


Three randomized controlled trials , with 1263 participants in total , were analyzed .


Median follow-up was 11 years .


Patients receiving chemotherapy followed by involved field radiotherapy had a significant benefit on event-free survival ( hazards ratio [ HR ] = 1.47 , 95 % confidence interval [ CI ] : 1.14 to 1.90 ; P = 0.003 ) , but not improved overall survival ( HR = 1.00 , 95 % CI : 0.80 to 1.25 ; P = 0.978 ) at 8 years , in relation to those in the chemotherapy alone arm .


There were great differences in the reporting of cumulative incidences of toxicity .


Chemotherapy followed by involved field radiotherapy , as compared with chemotherapy alone , is associated with better event-free survival , but no survival benefit is observed for patients for limited-stage aggressive non-Hodgkin 's lymphoma .


These results needed to be confirmed by high quality trials and further studies in the East .


Transcranial direct current stimulation ( tDCS ) is a neuromodulatory intervention with recent clinical trials showing promising results in major depression treatment .


Although tDCS has some appealing characteristics ( e.g. , low cost , ease of use , and relatively benign profile of adverse effects ) , one important drawback of the technique is the need to deliver consecutive , repeated sessions for several weekdays .


However , no study investigated whether absences during this acute treatment phase impact on tDCS efficacy , and , if so , whether absences should be considered dropouts , therefore increasing attrition .


To examine this issue , we used data from a randomized , factorial , sham-controlled tDCS study that recruited 120 depressed patients .


In this trial , the acute treatment phase consisted of ten consecutive sessions delivered once daily from Monday to Friday ; two nonconsecutive missed visits were allowed , with extra tDCS sessions being performed to complete the original number of sessions .


Our main finding was that the procedure of granting one to two absences during the acute treatment phase did not impact on tDCS antidepressant efficacy .


Moreover , out of 103 completers , only 41 ( 39.8 % ) patients presented no missing visits and 25 ( 24.3 % ) presented two absences .


These patients did not differ in clinical and demographic characteristics ; thus , absences were probably circumstantial ( e.g. , traffic congestion , personal obligations ) .


Absences during the acute tDCS treatment phase are common , which support the use of flexible schedules in future tDCS trials as to minimize attrition .


Also , further studies should access whether higher number of absences can compromise optimal tDCS efficacy .


To evaluate postural changes and the distribution of plantar pressures in patients with cystic fibrosis ( CF ) .


We also sought to evaluate the effects of an educational guideline for physical activity on body posture in children and adolescents with CF.


This was a 2-phase study of individuals between age 7 and 20 years .


Phase I was a cross-sectional study in which healthy subjects were selected for postural evaluation and baropodometry , aiming to perform a later comparison with patients with CF. In phase II , we performed a randomized controlled clinical trial to assess the influence of the exercise guideline on the postural changes .


Patients were assigned to 2 groups : control and intervention .


The intervention consisted of a handbook with instructions for aerobic exercise and stretching .


Main outcomes were postural abnormalities , plantar pressure distribution , and lung function .


In phase I , 34 patients with CF and 34 healthy matched individuals were included .


No significant baseline differences were identified .


Children with CF presented more postural deviations compared with healthy subjects ( P < .05 ) , as to alignment of the head , shoulder girdle , and pelvis , increased cervical lordosis , and lateral chest distance .


In phase II ( n = 34 ) , there were no baseline differences between groups .


The intervention caused ( P < .05 ) a decrease in cervical lordosis , thoracic kyphosis , lumbar lordosis , lateral chest distance , and abdominal protrusion , as well as in the baropodometric mean pressure and contact area .


Children and adolescents with CF present postural changes when compared with healthy individuals .


The educational guideline for exercise practice helped to improve posture , preventing the progression of some postural disorders .


To evaluate the efficacy and safety of adalimumab in patients with active nonpsoriatic peripheral spondyloarthritis ( SpA ) .


ABILITY-2 is an ongoing phase III , multicenter study of adalimumab treatment .


Eligible patients age 18 years fulfilled the Assessment of SpondyloArthritis international Society ( ASAS ) classification criteria for peripheral SpA , did not have a prior diagnosis of psoriasis , psoriatic arthritis ( PsA ) , or ankylosing spondylitis ( AS ) , and had an inadequate response or intolerance to nonsteroidal antiinflammatory drugs ( NSAIDs ) .


Patients were randomized 1:1 to receive adalimumab 40 mg every other week or matching placebo for 12 weeks , followed by a 144-week open-label period .


The primary end point was the proportion of patients achieving 40 % improvement in disease activity according to the Peripheral SpA Response Criteria ( PSpARC40 ) at week 12 .


This was defined as 40 % improvement from baseline ( 20-mm absolute improvement on a visual analog scale ) in patient 's global assessments of disease activity and pain , and 40 % improvement in at least one of the following features : swollen joint and tender joint counts , total enthesitis count , or dactylitis count .


Adverse events were recorded throughout the study .


In total , 165 patients were randomized to a treatment group , of whom 81 were randomized to receive placebo and 84 to receive adalimumab .


Baseline demographics and disease characteristics were generally similar between the 2 groups .


At week 12 , a greater proportion of patients receiving adalimumab achieved a PSpARC40 response compared to patients receiving placebo ( 39 % versus 20 % ; P = 0.006 ) .


Overall , improvement in other outcomes was greater in the adalimumab group compared to the placebo group .


The rates of adverse events were similar in both treatment groups .


Treatment with adalimumab ameliorated the signs and symptoms of disease and improved physical function in patients with active nonpsoriatic peripheral SpA who exhibited an inadequate response or intolerance to NSAIDs , with a safety profile consistent with that observed in patients with AS , PsA , or other immune-mediated diseases .


To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months .


Double blind , placebo controlled randomised trial .


Community based sample ( primary and secondary level care centres ) in Melbourne , Australia .


167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel 's criteria for crying or fussing : 85 were randomised to receive probiotic and 82 to receive placebo .


Oral daily L reuteri ( 1 10 ( 8 ) colony forming units ) versus placebo for one month .


The primary outcome was daily duration of cry or fuss at 1 month .


Secondary outcomes were duration of cry or fuss ; number of cry or fuss episodes ; sleep duration of infant at 7 , 14 , and 21 days , and 1 and 6 months ; maternal mental health ( Edinburgh postnatal depression subscale ) ; family functioning ( paediatric quality of life inventory ) , parent quality adjusted life years ( assessment of quality of life ) at 1 and 6 months ; infant functioning ( paediatric quality of life inventory ) at 6 months ; infant faecal microbiota ( microbial diversity , colonisation with Escherichia coli ) , and calprotectin levels at 1 month .


In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders .


Of 167 infants randomised from August 2011 to August 2012 , 127 ( 76 % ) were retained to primary outcome ; of these , a subset was analysed for faecal microbial diversity , E coli colonisation , and calprotectin levels .


Adherence was high .


Mean daily cry or fuss time fell steadily in both groups .


At 1 month , the probiotic group cried or fussed 49 minutes more than the placebo group ( 95 % confidence interval 8 to 90 minutes , P = 0.02 ) ; this mainly reflected more fussing , especially for formula fed infants .


The groups were similar on all secondary outcomes .


No study related adverse events occurred .


L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic .


These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants .


Current Controlled Trials ISRCTN95287767 .


The estimated prevalence of lumbar radiculopathy has been described as 9.8 per 1,000 cases of low back pain .


There are various surgical and nonsurgical modalities for treating lumbar disc herniation or radicular pain , including epidural injections .


Epidural injection administration routes include transforaminal , interlaminar , and caudal approaches .


The transforaminal approach requires the smallest volume to reach the primary site of pathology .


Systematic reviews have yielded highly variable results , but a recent systematic review showed no significant difference among the 3 approaches .


A randomized , controlled , double blind , active control trial .


An interventional pain management practice , a private specialty referral center in the United States .


To assess the effectiveness of transforaminal epidural injections of local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis .


One hundred twenty patients were randomly assigned to 2 groups : Group I received 1.5 mL of 1 % preservative-free lidocaine , followed by 0.5 mL of sodium chloride solution .


Group II received 1 % lidocaine , followed by 3 mg , or 0.5 mL of betamethasone .


The sodium chloride solution and betamethasone were either clear liquids or were provided in opaque-covered syringes .


The primary outcome measure was significant improvement ( at least 50 % ) measured by the average Numeric Rating Scale ( NRS ) and the Oswestry Disability Index 2.0 ( ODI ) .


Secondary outcome measures were employment status and opioid intake .


At 2 years there was significant improvement in all participants in 65 % who received local anesthetic alone and 57 % who received local anesthetic and steroid .


When separated into non-responsive and responsive categories based on initial relief of at least 3 weeks with 2 procedures , significant improvement ( at least 50 % improvement in pain and function ) was seen in 80 % in the local anesthetic group and 73 % in the local anesthetic with steroid group .


Presumed limitations of this evaluation include the lack of a placebo group .


Transforaminal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis .


The present evidence illustrates the lack of superiority of steroids compared with local anesthetic at 2-year follow-up .


Attribution theory claims that people who are stigmatized experience more negative emotional and behavioral reactions from others when they are thought to be responsible for their problems .


Accordingly , this study proposed a neurobiology-based psychoeducational intervention , which attempted to reduce people 's blameworthy attitudes toward and social distance from depressed individuals .


One hundred and thirty-two college students were randomly assigned to an experimental and control group .


Participants in the experimental group received a 30-min lecture on neurobiology-based psychoeducation for depressive disorders , and were asked to fill out questionnaires before and 2 weeks after the intervention .


The control group , with no intervention , also filled out the same questionnaires before and 2 weeks after the experiment .


The main contents of the neurobiology-based psychoeducation concerned the neurotransmission processes and biological mechanisms of depression , in order to emphasize the biological attribution of depression .


An ancova indicated that the neurobiology-based psychoeducational intervention significantly elevated the biological attribution of depression and reduced the social distance from depressed individuals .


Psychological blameworthy attitudes toward depression , however , did not significantly change .


Through a brief psychoeducation program about depression , knowledge of neuroscience could lead to positive benefits .


Public awareness that depression can be effectively prevented and treated may be a way in which people can accept depressed individuals .


Further studies are needed to certify the mechanisms of the effect of neurobiology-based psychoeducation .


After injury , eccentric exercise of the injured limb is often contraindicated .


Cross-education training , whereby the uninvolved limb is exercised , is an alternative that may improve quadriceps muscle strength and activation in the unexercised limb .


To determine the effect of eccentric exercise on quadriceps strength and activation gains in the unexercised limb .


Eighteen healthy individuals were randomly assigned to an eccentric training group or a control group .


Quadriceps strength and activation measures were collected at preintervention , midintervention , and postintervention .


Eccentric training participants exercised their dominant limb with a dynamometer in eccentric mode at 60/s , 3 times per week for 8 weeks .


Quadriceps strength was quantified at 30 and 60/s in concentric and eccentric modes .


Quadriceps activation was assessed using the burst superimposition technique and quantified via the central activation ratio .


A 2 3 repeated-measures analysis of variance was used to detect the effects of group and testing session on quadriceps strength and activation .


Where appropriate , post hoc Bonferroni multiple-comparisons procedures were used .


We found greater eccentric strength in the unexercised limbs of eccentric training participants between preintervention and midintervention and between preintervention and postintervention ( preintervention to midintervention : 30/s P = .05 ; preintervention to postintervention : 30/s P = .02 , 60/s P = .02 ) .


No differences were noted in concentric strength ( P > .05 ) .


An overall trend toward greater quadriceps activation in the unexercised knee was detected between preintervention and postintervention ( P = .063 ) , with the eccentric training group demonstrating a strong effect ( Cohen d = 0.83 ) .


Control strength did not change ( P > .05 ) .


Exercising with eccentric actions resulted in mode-specific and velocity-specific gains in quadriceps strength in the unexercised limb .


A trend toward greater quadriceps activation in the unexercised knee was noted , suggesting that strength gains may have occurred because of enhanced neural activity .


This type of therapy may be a useful addition to rehabilitation programs designed to improve quadriceps strength .


The inhaled corticosteroid fluticasone furoate ( FF ) in combination with the long-acting 2-agonist vilanterol ( VI ) is under development for the treatment of asthma and chronic obstructive pulmonary disease .


To compare the efficacy and safety of FF-VI and FF in patients ( 12 years old ) with persistent asthma .


In a randomized , double-blind , parallel-group study , patients ( n = 609 ) ( intent-to-treat population ) received FF-VI 100-25 mcg , FF 100 mcg , or placebo once daily ( evening ) by using a dry powder inhaler for 12 weeks .


Coprimary end points were change from baseline in trough FEV1 and serial ( 0-24 hours ) weighted mean FEV1 ( wmFEV ( 1 ) ) .


Rescue-free 24-hour periods and safety also were assessed .


Placebo increased trough FEV1 ( 196 mL ) and wmFEV ( 1 ) ( 212 mL ) versus baseline .


Compared with placebo , FF-VI and FF significantly improved trough FEV1 ( 172 mL [ P < .001 ] and 136 mL [ P = .002 ] ) , respectively , and serial wmFEV ( 1 ) ( 302 mL [ P < .001 ] and 186 mL [ P = .003 ] ) , respectively .


Treatment differences between FF-VI and FF approached significance for serial wmFEV ( 1 ) ( 116 mL ; P = .060 ) but not for trough FEV1 ( 36 mL ; P = .405 ) .


The percentage of rescue-free 24-hour periods with FF-VI was 10.6 % greater than FF and 19.3 % greater than placebo .


Statistically significant ( P = .032 ) urinary cortisol suppression was observed with FF-VI ( ratio , 0.82 ) relative to placebo , but not with FF .


Adverse event and safety profiles were similar across treatment groups .


Significant improvement in lung function was observed with FF-VI and FF versus placebo in patients with persistent asthma .


Improvement of FEV1 when VI was added to FF was not significant .


The high placebo response in evening trough FEV1 may have influenced the assessment of efficacy .


Although vitamin E and memantine have been shown to have beneficial effects in moderately severe Alzheimer disease ( AD ) , evidence is limited in mild to moderate AD .


To determine if vitamin E ( alpha tocopherol ) , memantine , or both slow progression of mild to moderate AD in patients taking an acetylcholinesterase inhibitor .


Double-blind , placebo-controlled , parallel-group , randomized clinical trial involving 613 patients with mild to moderate AD initiated in August 2007 and concluded in September 2012 at 14 Veterans Affairs medical centers .


Participants received either 2000 IU/d of alpha tocopherol ( n = 152 ) , 20 mg/d of memantine ( n = 155 ) , the combination ( n = 154 ) , or placebo ( n = 152 ) .


Alzheimer 's Disease Cooperative Study/Activities of Daily Living ( ADCS-ADL ) Inventory score ( range , 0-78 ) .


Secondary outcomes included cognitive , neuropsychiatric , functional , and caregiver measures .


Data from 561 participants were analyzed ( alpha tocopherol = 140 , memantine = 142 , combination = 139 , placebo = 140 ) , with 52 excluded because of a lack of any follow-up data .


Over the mean ( SD ) follow-up of 2.27 ( 1.22 ) years , ADCS-ADL Inventory scores declined by 3.15 units ( 95 % CI , 0.92 to 5.39 ; adjusted P = .03 ) less in the alpha tocopherol group compared with the placebo group .


In the memantine group , these scores declined 1.98 units less ( 95 % CI , -0.24 to 4.20 ; adjusted P = .40 ) than the placebo group 's decline .


This change in the alpha tocopherol group translates into a delay in clinical progression of 19 % per year compared with placebo or a delay of approximately 6.2 months over the follow-up period .


Caregiver time increased least in the alpha tocopherol group .


All-cause mortality and safety analyses showed a difference only on the serious adverse event of `` infections or infestations , '' with greater frequencies in the memantine ( 31 events in 23 participants ) and combination groups ( 44 events in 31 participants ) compared with placebo ( 13 events in 11 participants ) .


Among patients with mild to moderate AD , 2000 IU/d of alpha tocopherol compared with placebo resulted in slower functional decline .


There were no significant differences in the groups receiving memantine alone or memantine plus alpha tocopherol .


These findings suggest benefit of alpha tocopherol in mild to moderate AD by slowing functional decline and decreasing caregiver burden .


clinicaltrials.gov Identifier : NCT00235716 .


Cognitive dysfunction after subarachnoid hemorrhage ( SAH ) has been attributable to presence of subarachnoid blood , hydrocephalus ( HCP ) , cerebral edema , vasospasm , and temporary clipping of intracranial aneurysm .


Provision of neuroprotection during temporary clipping may improve postoperative cognition in such patients .


Good-grade aneurysmal SAH patients undergoing temporary clipping during surgery were allocated either to group C ( control ) or group P ( propofol ) .


Patients in group P received propofol in titrated doses to attain a burst suppression ratio of 75 5 % on bispectral index ( BIS ) monitor .


The cognitive function as assessed by Hindi-language modification of mini-mental state examination ( HMSE ) score was evaluated preoperatively , 24 h after surgery , and at discharge from hospital .


A score of 23 was indicative of cognitive dysfunction .


Perioperative complications , duration of intensive care unit ( ICU ) and hospital stay , and outcome at discharge were noted .


A total of 66 patients ( 32 and 34 in group C and P respectively ) were included in the study .


97 % of the patients had anterior circulation aneurysms .


At 24 h after surgery , eight and 12 patients in group C and P respectively ; and at discharge , five patients in each group had cognitive dysfunction .


In both groups , the trend showed a decline in cognition at 24 h followed by improvement at discharge .


Glasgow outcome score in both the groups was comparable ( P > 0.05 ) .


Intraoperative brain bulge , postoperative vasospasm , and cerebral infarction were found to be independent risk factors for cognitive dysfunction .


Pharmacologic neuroprotection with propofol at the time of temporary clipping during surgery for aneurysmal SAH did not offer any advantage as far as preservation of cognition is concerned .


The purpose of this article is to assess the effect of the adaptive statistical iterative reconstruction ( ASIR ) technique on image quality in hip MDCT arthrography and to evaluate its potential for reducing radiation dose .


Thirty-seven patients examined with hip MDCT arthrography were prospectively randomized into three different protocols : one with a regular dose ( volume CT dose index [ CTDIvol ] , 38.4 mGy ) and two with a reduced dose ( CTDIvol , 24.6 or 15.4 mGy ) .


Images were reconstructed using filtered back projection ( FBP ) and four increasing percentages of ASIR ( 30 % , 50 % , 70 % , and 90 % ) .


Image noise and contrast-to-noise ratio ( CNR ) were measured .


Two musculoskeletal radiologists independently evaluated several anatomic structures and image quality parameters using a 4-point scale .


They also jointly assessed acetabular labrum tears and articular cartilage lesions .


With decreasing radiation dose level , image noise statistically significantly increased ( p = 0.0009 ) and CNR statistically significantly decreased ( p = 0.001 ) .


We also found a statistically significant reduction in noise ( p = 0.0001 ) and increase in CNR ( p0 .003 ) with increasing percentage of ASIR ; in addition , we noted statistically significant increases in image quality scores for the labrum and cartilage , subchondral bone , overall diagnostic quality ( up to 50 % ASIR ) , and subjective noise ( p0 .04 ) , and statistically significant reductions for the trabecular bone and muscles ( p0 .03 ) .


Regardless of the radiation dose level , there were no statistically significant differences in the detection and characterization of labral tears ( n = 24 ; p = 1 ) and cartilage lesions ( n = 40 ; p0 .89 ) depending on the ASIR percentage .


The use of up to 50 % ASIR in hip MDCT arthrography helps to reduce radiation dose by approximately 35-60 % , while maintaining diagnostic image quality comparable to that of a regular-dose protocol using FBP .


The purpose of this study was to investigate the effects of different cold-water immersion ( CWI ) protocols on the inflammatory response to and functional recovery from high-intensity exercise .


Eight healthy recreationally active males completed five trials of a high-intensity intermittent sprint protocol followed by a randomly assigned recovery condition : 1 of 4 CWI protocols ( CWI-10 min 20 C , CWI-30 min 20 C , CWI-10 min 10 C , or CWI-30 min 10 C ) versus passive rest .


Circulating mediators of the inflammatory response were measured from EDTA plasma taken pre-exercise ( baseline ) , immediately post-exercise , and at 2 , 24 , and 48 h post-exercise .


Ratings of perceived soreness and impairment were noted on a 10-pt Likert scale , and squat jump and drop jump were performed at these time points .


IL-6 , IL-8 , and MPO increased significantly from baseline immediately post-exercise in all conditions .


IL-6 remained elevated from baseline at 2 h in the CWI-30 min 20 C , CWI-10 min 10 C , and CWI-30 min 10 C conditions , while further increases were observed for IL-8 and MPO in the CWI-30 min 20 C and CWI-30 min 10 C conditions .


Squat jump and drop jump height were significantly lower in all conditions immediately post-exercise and at 2 h. Drop jump remained below baseline at 24 and 48 h in the CON and CWI-10 min 20 C conditions only , while squat jump height returned to baseline in all conditions .


Cold-water immersion appears to facilitate restoration of muscle performance in a stretch-shortening cycle , but not concentric power .


These changes do not appear to be related to inflammatory modulation .


CWI protocols of excessive duration may actually exacerbate the concentration of cytokines in circulation post-exercise ; however , the origin of the circulating cytokines is not necessarily skeletal muscle .


The objective of the study was to determine the relative bioavailability of an extended-release multilayer bead formulation of methylphenidate hydrochloride ( MPH-MLR ) 80mg vs. methylphenidate immediate-release ( IR ; Ritalin ( ) ) tablets as single and multiple doses in the fed state .


A single-center , multiple-dose , randomized , open-label , two-period crossover study conducted in 26 healthy adults assigned to 4days of once-daily MPH-MLR 80mg or IR methylphenidate 25mg three times daily .


MPH-MLR 80mg produced reproducible biphasic profiles of plasma methylphenidate concentrations characterized by a rapid initial peak , followed by a moderate decline reaching a plateau ~ 5 h post dose , then a gradual increase culminating in an attenuated second peak ~ 7h post dose .


Maximum concentration was lower for MPH-MLR 80mg than IR methylphenidate 25mg three times daily on day 1 ( 23.70 vs. 31.47 ng/mL ) ; exposure was similar .


The geometric mean ratios ( MPH-MLR/IR methylphenidate [ 90 % CI ] ) of log-transformed area under the plasma drug concentration-time curve to the last measurable observation ( day 1 : 0.88 [ 84.75-91 .80 ] ; day 4 : 0.84 [ 81.16-86 .94 ] ) , and area under the plasma drug concentration extrapolated to infinity ( day 1 : 0.93 [ 88.57-97 .28 ] ; day 4 : 0.88 [ 84.48-91 .17 ] ) were within the 80-125 % bioequivalence range .


The meanSD MPH-MLR 80-mg capsule day 4 area under the plasma drug concentration vs. time curve from 0 to 4h ( 74.515.2 ngh/mL ) was greater than IR methylphenidate 25mg three times daily ( 66.017.4 ngh/mL ) , confirming steady-state levels during the study period .


All treatment regimens were safe and well tolerated .


MPH-MLR 80-mg capsule once daily or IR methylphenidate 25mg three times daily provides comparable maximum methylphenidate concentrations and systemic exposure in the fed state .


Racial and gender disparities for smoking cessation might be accounted for by differences in expectancies for tobacco interventions , but few studies have investigated such differences or their relationships with motivation to quit and abstinence self-efficacy .


In this cross-sectional study , 673 smokers ( African American : n = 443 , 65.8 % ; women : n = 222 , 33.0 % ) under criminal justice supervision who enrolled in a clinical smoking cessation trial in which all received bupropion and half received counseling .


All participants completed pretreatment measures of expectancies for different tobacco interventions , motivation to quit , and abstinence self-efficacy .


The indirect effects of race and gender on motivation to quit and abstinence self-efficacy through expectancies for different tobacco interventions were evaluated .


African Americans ' stronger expectancies that behavioral interventions would be effective accounted for their greater motivation to quit and abstinence self-efficacy .


Women 's stronger expectancies for the effectiveness of pharmacotherapy accounted for their greater motivation to quit , whereas their stronger expectancies for the effectiveness of behavioral treatments accounted for their greater abstinence self-efficacy .


Findings point to the mediating role of expectancies for treatment effectiveness and suggest the importance of exploring expectancies among African Americans and women as a way to augment motivation and self-efficacy .


GLP-1 receptor ( GLP-1R ) agonists induce natriuresis and reduce blood pressure ( BP ) through incompletely understood mechanisms .


We examined the effects of acute and 21-day administration of liraglutide on plasma atrial natriuretic peptide ( ANP ) , urinary sodium excretion , office and 24-h BP , and heart rate ( HR ) .


Liraglutide or placebo was administered for 3 weeks to hypertensive subjects with type 2 diabetes in a double-blinded , randomized , placebo-controlled crossover clinical trial in the ambulatory setting .


End points included within-subject change from baseline in plasma ANP , Nt-proBNP , office BP , and HR at baseline and over 4 h following a single dose of liraglutide ( 0.6 mg ) and after 21 days of liraglutide ( titrated to 1.8 mg ) versus placebo administration .


Simultaneous 24-h ambulatory BP and HR monitoring and 24-h urine collections were measured at baseline and following 21 days of treatment .


Plasma ANP levels did not change significantly after acute ( +16.72 pg/mL , P = 0.24 , 95 % CI [ -12.1 , +45.5 ] at 2 h ) or chronic ( -17.42 pg/mL , 95 % CI [ -36.0 , +1.21 ] at 2 h ) liraglutide administration .


Liraglutide significantly increased 24-h and nighttime urinary sodium excretion ; however , 24-h systolic BP was not significantly different .


Small but significant increases in 24-h and nighttime diastolic BP and HR were observed with liraglutide .


Body weight , HbA1c , and cholesterol were lower , and office-measured HR was transiently increased ( for up to 4 h ) with liraglutide administration .


Sustained liraglutide administration for 3 weeks increases urinary sodium excretion independent of changes in ANP or BP in overweight and obese hypertensive patients with type 2 diabetes .


To determine the ability of sheep to mobilise their body reserves after being deprived of feed prior to transport for slaughter .


A total of 240 3 - and 4-year-old cull ewes were held off pasture for 0 , 9 , 18 or 30 hours ( n = 60 per group ) then transported 1 hour by road , unloaded and washed , held in lairage for 3 hours then slaughtered .


Blood samples were collected from a subsample of 60 unfasted ewes 1 week earlier , and from all ewes at exsanguination to determine concentrations of serum metabolites indicative of adaptation to fasting .


In addition , several attributes of carcass quality were measured .


At slaughter , increased time off pasture prior to transport resulted in no change in glucose concentrations in serum ( p = 0.140 ) .


There were differences ( p < 0.001 ) between the group fasted for 30 compared with 0 hours in mean concentrations of free fatty acids ( 0.98 ( SD 0.32 ) vs. 0.58 ( SD 0.23 ) mmol/L ) , - hydroxybutyrate ( 0.69 ( SD 0.17 ) vs. 0.42 ( SD 0.11 ) mmol/L ) , triglycerides ( 0.29 ( min 0.13 , max 0.83 ) vs. 0.22 ( min 0.06 , max 0.96 ) mmol/L ) and urea ( 10.17 ( SD 1.80 ) vs. 6.94 ( SD 2.03 ) mmol/L ) .


Different periods of feed deprivation had no effect ( p > 0.05 ) on carcass weights ( mean 22.7 , min 13.2 , max 32.9 kg ) or dressing out percentages ( mean 40.9 , min 27 , max 49 % ) .


Meat ultimate pH was unaffected ( p > 0.05 ) by the period of feed deprivation but meat became darker ( p < 0.05 ) and had reduced redness ( p < 0.001 ) with increasing time off feed .


The results suggest that sheep in variable body condition adapted to the periods of feed deprivation by mobilising their energy reserves without any evidence of metabolic depletion ( e.g. depleted blood glucose or high meat pH ) .


However , being deprived of feed they probably experience a degree of hunger .


Spectacle independence is becoming increasingly important in cataract surgery .


Not correcting corneal astigmatism at the time of cataract surgery will fail to achieve spectacle independency in 20 % to 30 % of patients .


To compare bilateral aspherical toric with bilateral aspherical control intraocular lens ( IOL ) implantation in patients with cataract and corneal astigmatism .


A multicenter , hospital-based , randomized clinical trial was conducted .


The participants included 86 individuals with bilateral cataract and bilateral corneal astigmatism of at least 1.25 diopters ( D ) who were randomized to receive either bilateral toric ( n = 41 ) or bilateral control ( n = 45 ) IOL implantation .


Bilateral implantation of an aspherical toric IOL or an aspherical control IOL .


Spectacle independency for distance vision , uncorrected distance visual acuity , refractive astigmatism , contrast sensitivity , wavefront aberrations , and refractive error-related quality-of-life questionnaire .


Preoperatively , mean ( SD ) corneal astigmatism was 2.02 ( 0.95 ) D and 2.00 ( 0.84 ) D in the toric and control groups , respectively .


Four patients ( 5 % ) were lost to follow-up .


At 6 months postoperatively , 26 ( 70 % ) of the patients in the toric group achieved an uncorrected distance visual acuity of 20/25 or better compared with 14 ( 31 % ) in the control group ( P < .001 ; odds ratio , 5.23 ; 95 % CI , 2.03-13 .48 ) .


Spectacle independency for distance vision was achieved in 31 patients ( 84 % ) in the toric group compared with 14 patients ( 31 % ) in the control group ( P < .001 ; odds ratio , 11.44 ; 95 % CI , 3.89 - 33.63 ) .


Mean refractive astigmatism was -0.77 ( 0.52 ) D and -1.89 D ( 1.00 ) D , respectively .


Vector analysis of toric IOLs showed a mean magnitude of error of +0.38 D , indicative of overcorrection .


No significant differences were found in contrast sensitivity , higher-order aberrations , or refractive error-related quality of life .


In patients with cataract and corneal astigmatism , bilateral toric IOL implantation results in a higher spectacle independency for distance vision compared with bilateral control IOL implantation .


No significant differences were identified in contrast sensitivity , higher-order aberrations , or refractive error-related quality of life following both treatments .


clinicaltrials.gov Identifier : NCT01075542 .


This study 's purpose was to evaluate the success of calcium hydroxide ( CH ) and mineral trioxide aggregate ( MTA ) pulpotomies following the use of five percent sodium hypochlorite ( NaOCl ) as an antibacterial agent to clean the chamber prior to application of the pulpotomy agent .


A total of 128 teeth were randomly divided into two pulpotomy groups ( CH or MTA ) .


The teeth in each pulpotomy group , CH and MTA , were further randomly divided into subgroups to receive either the NaOCl ( experimental ) or saline ( control ) cleaning agent prior to applying the pulpotomy agent .


The treatments were followed clinically and radiographically for 12 months .


The radiographic success rates were 84 percent for CH NaOCl , 74 percent for CH saline control , 97 percent for MTA NaOCl , and 100 percent for MTA saline control .


There were no significant differences between the radiographic success rates in the CH and MTA subgroups ( CH NaOCl-CH control and MTA NaOCl-MTA control ) ; no significant differences were observed when comparing the CH NaOCl-MTA NaOCl groups and the CH NaOCl-MTA control groups .


Use of sodium hypochlorite as an antibacterial agent prior to application of the pulpotomy agent improved the success of calcium hydroxide pulpotomies to equal the success of mineral trioxide aggregate pulpotomies for observation up to 12 months .


A treatment strategy to inhibit nonsteroidal anti-inflammatory drug ( NSAID ) - induced small intestinal lesions has not yet been established .


To clarify whether monotherapy with a gastromucoprotective drug , geranylgeranylacetone ( GGA ) , inhibits NSAID-induced acute mucosal injury of the upper digestive tract and small intestine .


A prospective , randomized , comparative study .


All procedures were performed at Osaka Medical College .


The subjects , thirty healthy adult volunteers , were randomly divided into two groups .


In the NSAID-GGA group , 75 mg/day of diclofenac sodium and 150 mg/day of GGA were orally administered for two weeks .


In the NSAID-FAM group , 75 mg/day of diclofenac sodium and 20 mg/day of famotidine ( FAM ) were orally administered for two weeks .


esophagogastroduodenoscopy ( EGD ) and video capsule endoscopy ( VCE ) were performed before and two weeks after drug administration .


In addition , we measured fecal occult blood reactions and the fecal calprotectin levels .


No significant differences were observed between the groups in the mean increase in esophageal/gastroduodenal lesions .


The mean increases in the scores in the NSAID-FAM group ( NSAID-GGA group ) of small bowel lesions were as follows : erythema : 1.93 0.67 ( 0.30 0.60 ) , erosions : 1.13 0.54 ( 0.38 0.35 ) , ulcers : 0.73 0.33 ( 0.07 0.07 ) and edema : 0.53 0.44 ( 0.07 0.07 ) .


The scores for erythema and ulcers were significantly lower in the NSAID-GGA group than in the NSAID-FAM group ( p = 0.032 and 0.0165 , respectively ) .


We compared the prophylactic effects of a mucoprotective drug , GGA , and an H2RA , famotidine , on mucosal injury involving the esophagus to the small intestine related to the two-week oral administration of diclofenac sodium in healthy volunteers .


In the upper digestive tract , the prophylactic effects were similar between the two drugs .


However , in the small intestine , GGA more markedly inhibited the development of lesions compared to famotidine .


A small number of studies conducted to date have suggested that transcranial direct current stimulation ( tDCS ) applied to the temporoparietal cortex may reduce auditory hallucinations in patients with schizophrenia .


Prefrontal brain stimulation with other methods , has also been shown to potentially improve the negative symptoms of this disorder .


To investigate the therapeutic potential of daily bimodal tDCS : anodal stimulation to the prefrontal cortex and cathodal stimulation to the temporoparietal junction in patients with persistent hallucinations and negative symptoms of schizophrenia .


We conducted two small randomized double-blind controlled trials comparing bimodal tDCS to sham stimulation .


In one study , stimulation was provided unilaterally , in the second study it was provided bilaterally .


Neither unilateral nor bilateral tDCS resulted in a substantial change in either hallucinations or negative symptoms .


Stimulation was well tolerated without side-effects .


Daily tDCS does not appear to have substantial potential in the treatment of hallucinations or negative symptoms and further research should investigate higher doses of stimulation or more frequently applied treatment schedules .


An emergency department ( ED ) visit may be an effective place to screen and educate families about injury prevention .


The purpose of this study was to determine if a computerized kiosk in a pediatric ED can screen families for injury risk and encourage them to make more safety changes at follow-up survey compared with an injury prevention specialist ( IPS ) .


A prospective , randomized controlled study was performed with families of children younger than 14 years in an ED lobby .


Families were screened for injury risk by computerized kiosk based on child 's age category at triage ( birth to 1 year , 1-4 years , 5-9 years , or 10-14 years ) .


Families were randomized to receive either injury behavior instructions by kiosk printout or by IPS when answers to specific practices were deemed unsafe .


Three weeks after intervention , families were telephoned to determine change in safety practices .


Three hundred seventeen families completed ED kiosk screen at enrollment ( 172 kiosk , 145 IPS ) .


On initial screen , kiosk families practiced 79.6 % of behaviors safely versus 75.9 % in the IPS group ( p = 0.011 ) .


A total of 221 families ( 69.7 % ) were reached for follow-up ( 121 kiosk , 100 IPS ) .


On average , IPS families improved their safe behavior responses by 8.3 % versus 1.0 % in the kiosk group ( p < 0.0001 ) .


Significantly more families in the IPS group than in the kiosk group ( 36 % vs. 23 % , p < 0.03 ) used additional safety equipment after the intervention .


A computerized kiosk based in a pediatric ED can help screen families for their injury risk .


However , to elicit significant behavior change , an IPS discussing safety changes may be more effective .


To compare the efficacy of postoperative topical nepafenac ( 0.1 % ) with prednisolone acetate ( 1 % ) as anti-inflammatory agents in eyes undergoing Transscleral Sutureless Vitrectomy ( TSV ) .


Prospective , double-blind , randomized , single center clinical study .


Eighty eyes of 76 subjects , who underwent small gauge vitrectomy , were included in the study .


The subjects who fulfilled the inclusion criteria were randomized to either topical nepafenac only ( Group 1 ) or prednisolone acetate only ( Group 2 ) , to be used as postoperative anti-inflammatory agents .


The subjects were reviewed on days 1 , 30 , and 90 .


Ocular and adnexal inflammation was appropriately graded using the standardized classification .


Grading of ocular pain was done on the Visual Analog Scale ( VAS ) .


The Wilcoxon rank-sum test , using two-sided analysis , was used .


During the follow-up , both Group 1 and Group 2 did not have a significant difference related to the grade of the anterior chamber inflammation ( P > 0.05 ) or adnexal inflammation ( P > 0.05 ) .


Pain perception was less in the subjects in Group 1 as compared to subjects in Group 2 , but was not statistically significant ( P > 0.05 ) .


Postoperative topical nepafenac was non-inferior to prednisolone acetate in reducing postoperative ocular inflammation in eyes undergoing TSV .


Environmental enteropathy ( EE ) is a subclinical condition among children in the developing world , characterized by T-cell infiltration of the small-bowel mucosa and diffuse villous atrophy .


EE leads to macronutrient and micronutrient malabsorption and stunting , with a resultant increased risk for infection and reduced cognitive development .


We tested the hypothesis that zinc and albendazole treatments would reduce the severity of EE in rural African children .


In a randomized , double-blind , placebo-controlled trial in rural southern Malawi , asymptomatic children , 1 to 3 years old and at high risk for EE , received either a single dose of albendazole , a 14-day course of 20 mg zinc sulfate , or a placebo .


Subjects were given the dual-sugar absorption test , and the ratio of lactulose to mannitol ( L : M ) in urine was used to determine the severity of EE at baseline and 34 days after completion of the assigned regimen .


The primary outcome was the change in the L : M.


A complete set of urine samples was obtained from 222 of 234 children enrolled and analyzed .


The mean baseline L : M was 0.32 0.18 among all children and did not differ among groups ( normal L : M range , < 0.12 ) .


At the end of the study , the L : M ratio had increased more in the placebo group ( 0.12 0.31 ) than in the zinc group ( 0.03 0.20 ; P < .03 ) or the albendazole group ( 0.04 0.22 ; P < .04 ) .


Treatment with zinc or albendazole protects against a significant increase in the L : M ratio , a biomarker for EE , in asymptomatic rural Malawian children .


These findings could provide insight into the etiology and pathogenesis of EE .


Clinicaltrials.gov Number : NCT01440608 .


Cancer-related malnutrition is multifactorial and related to a bad prognosis .


The aim of this study was to investigate the effect of intensive , individual dietary counseling of patients in radiotherapy and/or chemotherapy for gynecologic - , gastric - , or esophageal cancer .


61 outpatients were stratified by diagnoses and randomly assigned to one of two groups ( G1 ; n = 32 and G2 ; n = 29 ) .


The basic regimen , applied to both groups , included measurement of body weight , 24-h dietary recall interview , micronutrient status and quality of life .


In addition G1 received intensive , individual dietary counseling one hour per week and , if the patient accepted , a daily oral nutritional supplement containing 2531 kJ , 33.8 g protein and 2.2 g EPA .


At the end of the treatment period , significantly fewer patients had lost weight in the intervention group ( mean : 44 % vs. 72 % , p < 0.05 ) , and the fulfillment of estimated energy requirements was better during treatment ( mean : 107 % vs. 95 % , p < 0.05 ) .


A significant positive effect was observed on the fulfillment of protein requirement , both during the treatment period ( mean : 92 % vs. 71 % , p < 0.001 ) and at follow-up ( mean : 86 % vs. 71 % , p < 0.05 ) .


In these cancer patients , intensive , individual dietary counseling was associated with a better weight maintenance and a higher provision of adequate amounts of protein and energy .


The intervention had no significant effects on patients ' quality of life , incidence of treatment-related side effects or appearance of micronutrient deficiencies .


Chronic inflammation is hypothesized to influence prostate cancer development , although a definitive link has not been established .


Prostate cancer cases ( N = 191 ) detected on a for-cause ( clinically indicated ) or end-of-study ( protocol directed ) biopsy , and frequency-matched controls ( N = 209 ) , defined as negative for cancer on an end-of-study biopsy , were sampled from the placebo arm of the Prostate Cancer Prevention Trial .


Inflammation prevalence and extent in benign areas of biopsy cores were visually assessed using digital images of hematoxylin and eosin-stained sections .


Logistic regression was used to estimate associations .


Of note , 86.2 % of cases and 78.2 % of controls had at least one biopsy core ( of three assessed ) with inflammation in benign areas , most of which was chronic .


Men who had at least one biopsy core with inflammation had 1.78 [ 95 % confidence interval ( CI ) , 1.04-3 .06 ] times the odds of prostate cancer compared with men who had zero cores with inflammation .


The association was stronger for high-grade disease ( Gleason sum 7-10 , N = 94 ; OR , 2.24 ; 95 % CI , 1.06-4 .71 ) .


These patterns were present when restricting to cases and controls in whom intraprostatic inflammation was the least likely to have influenced biopsy recommendation because their prostate-specific antigen ( PSA ) was low ( < 2 ng/mL at biopsy ) .


Inflammation , most of which was chronic , was common in benign prostate tissue , and was positively associated with prostate cancer , especially high grade .


The association did not seem to be due to detection bias .


This study supports an etiologic link between inflammation and prostate carcinogenesis , and suggests an avenue for prevention by mitigating intraprostatic inflammation .


The aims of this study were to establish a bioanalytical method and to evaluate the bioequivalence of two drug products ; a generic sildenafil 50 mg film-coated vs. the brand drug Viagra 50 mg film-coated tablets .


Bioequivalence of tablets was tested by comparisons against the reference brand product in accordance with the requirements of the Declaration of Helsinki , the current Good Clinical Practice ( GCP ) Guidelines and the International Conference Harmonization ( ICH ) .


The relationship between concentration and peak area ratio was found to be linear within the range of 1.435 - 410.023 ng/mL for sildenafil .


The correlation coefficient ( r ) was always greater than 0.99 during the course of the validation Statistical comparison of the main pharmacokinetic parameters showed no significant difference between test and reference .


The 90 % CIs of geometric mean ratios ( test to reference ratios ) were 99.656 % , 99.806 % , and 109.227 % for AUC ( 0-last ) , AUC ( 0 - ) , and C ( max ) , respectively .


These pharmacokinetic parameter values lie within the FDA and European Medicines Agency specified bioequivalence limit ( 80 - 125 % ) .


Both formulations were well tolerated by all subjects and they were discharged in good health .


The tested drug product was bioequivalent to the reference drug and had the same safety profile .


Functional neuroimaging studies implicate anterior cingulate and limbic dysfunction in major depressive disorder ( MDD ) and responsiveness to antidepressants .


Diffusion tensor imaging ( DTI ) enables characterisation of white matter tracts that relate to these regions .


To examine whether DTI measures of anterior cingulate and limbic white matter are useful prognostic biomarkers for MDD .


Of the 102 MDD out-patients from the International Study to Predict Optimized Treatment for Depression ( iSPOT-D ) who provided baseline magnetic resonance imaging ( MRI ) data , 74 completed an 8-week course of antidepressant medication ( randomised to escitalopram , sertraline or extended-release venlafaxine ) and were included in the present analyses .


Thirty-four matched controls also provided DTI data .


Fractional anisotropy was measured for five anterior cingulate-limbic white matter tracts : cingulum cingulate and hippocampus bundle , fornix , stria terminalis and uncinate fasciculus .


( Trial registered at ClinicalTrials.gov : NCT00693849 . )


A cross-validated logistic regression model demonstrated that altered connectivity for the cingulum part of the cingulate and stria terminalis tracts significantly predicted remission independent of demographic and clinical measures with 62 % accuracy .


Prediction improved to 74 % when age was added to this model .


Anterior cingulate-limbic white matter is a useful predictor of antidepressant treatment outcome in MDD .


Type 2 diabetes is known to be associated with increasing cardiovascular mortality .