Both the transversus abdominis plane block and systemically administered lidocaine have already been reported to effectively reduce pain after laparoscopic colorectal surgery .


We hypothesize that the transversus abdominis plane block is superior to perioperative intravenous lidocaine .


One hundred and twenty five patients undergoing laparoscopic colorectal surgery will be included in this prospective , randomized , double-blind controlled clinical trial .


Patients will be randomly allocated to three different postoperative strategies : postoperative patient-controlled intravenous analgesia with morphine ( control group , n = 25 ) , a transversus abdominis plane block with ropivacaine 0.375 % at the end of surgery plus postoperative patient-controlled intravenous analgesia with morphine ( TAP group , n = 50 ) , or perioperative intravenous lidocaine plus postoperative patient-controlled intravenous analgesia with morphine ( LIDO group , n = 50 ) .


As the primary outcome parameter , we will evaluate the opioid consumption during the first 24 postoperative hours .


Secondary endpoints include the Numeric Rating Scale , time to return of intestinal function , time to mobilization , inflammatory response , incidence of postoperative nausea and vomiting , length of hospital stay and postoperative morbidity as assessed with the Clavien-Dindo classification .


Recognizing the importance of a multimodal approach for perioperative pain management , we aim to investigate whether a transversus abdominis plane block delivers superior pain control in comparison to perioperative intravenous lidocaine and patient-controlled intravenous analgesia with morphine alone .


EudraCT Identifier : 2014-001499-73 ; 31 July 2014 .


Musculoskeletal disorders are the most frequent occupational diseases in Europe .


However , their multifactorial aetiology poses several challenges concerning not only the estimation of relative prevalence rates across occupational groups but also how the co-occurrence of known risk factors might differ between disorders of the upper and lower limbs .


Against this background , the following objectives are pursued : ( 1 ) to estimate the relative odds and prevalence rates of self-reported disorders of the upper limbs and/or shoulders and neck ( upper body ) and the lower limbs for major ISCO-88 occupational groups , ( 2 ) to evaluate to what extent the associations between known risk factors differ for musculoskeletal disorders of the upper body and the lower limbs .


Statistical analysis of cross-sectional data from the European Working Conditions Survey 1995-2010 .


The probability of reporting upper body and lower limbs pain in the survey sample 2010 is estimated by mixed logistic regression models using the Markov chain Monte Carlo Sampler .


Independent variables include some known physical and psychosocial risk factors .


Concerning the first objective , an excess risk of reporting musculoskeketal disorders of the upper body was observed among craft workers ( ISCO 7 ) , machine operators ( ISCO 8 ) and workers in elementary occupations ( ISCO 9 ) .


Concerning musculoskeletal disorders of the lower limbs , service and sales workers ( ISCO 5 ) and workers in ISCO groups 7 , 8 and 9 reported symptoms more frequently .


Regarding the second objective , similar association patterns were observed for upper body and lower limbs symptoms .


Major physical risk factors associated with both symptom types were very frequent exposure to tiring positions , carrying heavy loads and performing repetitive tasks .


Standing appears to be an important risk factor for lower limbs symptoms only .


Results suggest that the unequal burden of exposure has not changed substantially across occupational groups since 1995 , and that there is urgent need of delivering and evaluating the effects of specific interventions targeting workers at high risk of developing musculoskeletal disorders .


Medical conditions are often complicated by major depression , with consequent additional impairment of quality of life .


We aimed to compare the effectiveness of an integrated treatment programme for major depression in patients with cancer ( depression care for people with cancer ) with usual care .


SMaRT Oncology-2 is a parallel-group , multicentre , randomised controlled effectiveness trial .


We enrolled outpatients with major depression from three cancer centres and their associated clinics in Scotland , UK .


Participants were randomly assigned in a 1:1 ratio to the depression care for people with cancer intervention or usual care , with stratification ( by trial centre ) and minimisation ( by age , primary cancer , and sex ) with allocation concealment .


Depression care for people with cancer is a manualised , multicomponent collaborative care treatment that is delivered systematically by a team of cancer nurses and psychiatrists in collaboration with primary care physicians .


Usual care is provided by primary care physicians .


Outcome data were collected up until 48 weeks .


The primary outcome was treatment response ( 50 % reduction in Symptom Checklist Depression Scale [ SCL-20 ] score , range 0-4 ) at 24 weeks .


Trial statisticians and data collection staff were masked to treatment allocation , but participants could not be masked to the allocations .


Analyses were by intention to treat .


This trial is registered with Current Controlled Trials , number ISRCTN40568538 .


500 participants were enrolled between May 12 , 2008 , and May 13 , 2011 ; 253 were randomly allocated to depression care for people with cancer and 247 to usual care .


143 ( 62 % ) of 231 participants in the depression care for people with cancer group and 40 ( 17 % ) of 231 in the usual care group responded to treatment : absolute difference 45 % ( 95 % CI 37-53 ) , adjusted odds ratio 85 ( 95 % CI 55-134 ) , p < 00001 .


Compared with patients in the usual care group , participants allocated to the depression care for people with cancer programme also had less depression , anxiety , pain , and fatigue ; and better functioning , health , quality of life , and perceived quality of depression care at all timepoints ( all p < 005 ) .


During the study , 34 cancer-related deaths occurred ( 19 in the depression care for people with cancer group , 15 in the usual care group ) , one patient in the depression care for people with cancer group was admitted to a psychiatric ward , and one patient in this group attempted suicide .


None of these events were judged to be related to the trial treatments or procedures .


Our findings suggest that depression care for people with cancer is an effective treatment for major depression in patients with cancer .


It offers a model for the treatment of depression comorbid with other medical conditions .


Cancer Research UK and Chief Scientist Office of the Scottish Government .


Buprenorphine is a promising treatment for heroin addiction .


However , little is known regarding its provision to pre-release prisoners with heroin dependence histories who were not opioid-tolerant , the relative effectiveness of the post-release setting in which it is provided , and gender differences in treatment outcome in this population .


This is the first randomized clinical trial of prison-initiated buprenorphine provided to male and female inmates in the US who were previously heroin-dependent prior to incarceration .


A total of 211 participants with 3-9 months remaining in prison were randomized to one of four conditions formed by crossing In-Prison Treatment Condition ( received buprenorphine vs. counseling only ) and Post-release Service Setting ( at an opioid treatment center vs. a community health center ) .


Outcome measures were : entered prison treatment ; completed prison treatment ; and entered community treatment 10 days post-release .


There was a significant main effect ( p = .006 ) for entering prison treatment favoring the In-Prison buprenorphine Treatment Condition ( 99.0 % vs. 80.4 % ) .


Regarding completing prison treatment , the only significant effect was Gender , with women significantly ( p < .001 ) more likely to complete than men ( 85.7 % vs. 52.7 % ) .


There was a significant main effect ( p = .012 ) for community treatment entry , favoring the In-Prison buprenorphine Treatment Condition ( 47.5 % vs. 33.7 % ) .


Buprenorphine appears feasible and acceptable to prisoners who were not opioid-tolerant and can facilitate community treatment entry .


However , concerns remain with in-prison treatment termination due to attempted diversion of medication .


We evaluated the efficacy of sub-Tenon block in decreasing perioperative pain , incidence of intraoperative oculocardiac reflex ( OCR ) , and postoperative nausea and vomiting ( PONV ) in pediatric squint surgery .


A total of 67 children age 2-12 years , American Society of Anesthesiologists Physical Status 1 and 2 , were randomized to receive either sub-Tenon block ( ST ) in the operative eye or 2 mcg/kg of intravenous fentanyl ( F ) for squint surgery after induction of general anesthesia in this double-blind study .


Postoperative pain was measured by either modified Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) or Visual Analogue Scale ( VAS ) .


Pain in the postoperative period ( up to 2 hours ) was measured as the primary endpoint .


Other parameters measured in the groups were intraoperative hemodynamics , postoperative modified CHEOPS or VAS at shifting , 1 , 2 , 6 , 12 , and 24 hours after surgery , incidence of intraoperative OCR , and PONV at shifting , 30 minutes , 1 , 2 , 6 , 12 , and 24 hours after surgery .


There was no statistical difference in the postoperative pain scores in the recovery room up to 2 hours after surgery .


The VAS and CHEOPS scores were not different in the groups up to 24 hours after surgery .


The incidence of OCR was significantly higher in group F than group ST. The incidence of PONV was significantly higher in group F than group ST at 30 minutes and 1 hour after the surgery ( 41 % , 47 % vs 19 % , 9 % , respectively , p < 0.05 ) .


However , there was no statistically significant difference in intraoperative hemodynamics and PONV scores after 2 hours in the postanesthesia care unit .


Use of sub-Tenon block does not decrease the incidence of postoperative pain significantly in children undergoing squint surgery .


However , it leads to a statistically significant decrease in the incidence of intraoperative OCR and PONV in the early recovery period in these patients .


This study presents an interim safety and feasibility analysis of the REGENERATE-IHD randomized controlled trial , which is examining the safety and efficacy of three different delivery routes of bone marrow-derived stem cells ( BMSCs ) in patients with ischemic heart failure .


The first 58 patients recruited to the REGENERATE-IHD study are included in this interim analysis ( pilot ) .


Symptomatic patients with ischemic heart failure were randomized to receive subcutaneous granulocyte colony-stimulating factor or saline injections only ; or subcutaneous granulocyte colony-stimulating factor injections followed by intracoronary or intramyocardial injections of BMSCs or serum ( control ) .


No significant differences were found in terms of safety and feasibility between the different delivery routes , with no significant difference in procedural complications or major adverse cardiac events .


There was a signal towards improved heart failure symptoms in the patients treated with intramyocardial injection of mobilized BMSCs .


Peripheral mobilization of BMSCs with or without subsequent direct myocardial delivery appears safe and feasible in patients with chronic ischemic heart failure .


The purpose of this study was to prospectively evaluate the effect of benzyl alcohol , a common preservative in normal saline , on postprocedural pain after intraarticular injection for direct shoulder MR arthrography .


From April 2011 through January 2013 , 138 patients underwent direct shoulder MR arthrography .


Using the Wong-Baker Faces Pain Scale , patients were asked to report their shoulder pain level immediately before and immediately after the procedure and then were contacted by telephone 6 , 24 , and 48 hours after the procedure .


Fourteen patients did not receive the prescribed amount of contrast agent for diagnostic reasons or did not complete follow-up .


Sixty-two patients received an intraarticular solution including preservative-free normal saline ( control group ) and 62 patients received an intraarticular solution including normal saline with 0.9 % benzyl alcohol as a contrast diluent ( test group ) .


Patients were randomized as to which intraarticular diluent they received .


Fluoroscopic and MR images were reviewed for extracapsular contrast agent administration or extravasation , full-thickness rotator cuff tears , and adhesive capsulitis .


The effect of preservative versus control on pain level was estimated with multiple regression , which included time after procedure as the covariate and accounted for repeated measures over patients .


Pain scale scores were significantly ( p = 0.0382 ) higher ( 0.79 units ; 95 % CI , 0.034-1 .154 ) with benzyl alcohol preservative compared with control ( saline ) .


In both study arms , the pain scale scores decreased slightly after the procedure , increased by roughly 1 unit over baseline for the test group and 0.3 unit over baseline for the control group by 6 hours after the procedure , were 0.50 unit over baseline for the test group and 0.12 unit over baseline for the control group at 24 hours , then fell to be slightly greater than baseline at 48 hours with benzyl alcohol and slightly less than baseline without benzyl alcohol .


These trends over time were highly significant ( p < 0.0001 ) .


Shoulder arthrography is often associated with postprocedural discomfort that begins immediately after the procedure and resolves by 48 hours .


There is significantly increased patient discomfort at 6 and 48 hours when using normal saline preserved with benzyl alcohol as a diluent compared with using normal saline without preservative as a diluent .


Antecedents of smoking have been widely researched in studies with older adults .


However , less is known about the smoking patterns and antecedents of smoking in young adult smokers .


In this study , we used ecological momentary assessment collected with an Internet-based survey instrument and used the participants ' own mobile phones to contrast the smoking patterns of young adult light and intermittent smokers ( n = 23 ) with heavy smokers ( n = 18 ) .


Overall , 1543 smoking and non-smoking situations were analysed .


By means of generalised estimating equations , we used a range of situational characteristics to predict smoking in both groups .


Craving and smoking of others increased the odds of smoking , and smoking bans were associated with a decreased probability of smoking among both light and intermittent smokers and heavy smokers .


Situational antecedents differed between both groups .


Cue-associated smoking played a bigger role for light and intermittent smokers than for heavy smokers .


Situational antecedents , such as craving , being at the home of others , drinking alcohol and smoking by others , were more strongly associated with the smoking of light and intermittent smokers compared with heavy smokers .


Smoking among young adults is associated with both internal and external situational characteristics .


Compared with heavy smokers , light and intermittent smoking seems to be under more stimulus control and more characterised by social smoking .


These results are consistent with several findings from previous studies and provide further information on different subgroups of smokers in early adulthood .


To compare the quality of data collection via electronic data capture ( EDC ) with voiced questionnaire ( QNN ) and data image capture features using a tablet versus standard paper-based QNN , to assess the user 's perception of using the EDC tool , and to compare user satisfaction with the two methods .


Randomised cross-over study .


Study sites : This study was conducted in two villages along the Thailand-Myanmar border .


This study included 30 community health volunteers ( CHVs ) and 120 Karen hill tribe villagers .


Employing a cross-over study design , the CHVs were allocated randomly to two groups , in which they performed interviews in different sequences using EDC and QNN .


Data discrepancies were found between the two data-collection methods , when data from the paper-based and image-capture methods were compared , and when conducting skip pattern questions .


More than 90 % of the CHVs perceived the EDC to be useful and easy to use .


Both interviewers and interviewees were more satisfied with the EDC compared with QNN in terms of format , ease of use , and system speed .


The EDC can effectively be used as an alternative method to paper-based QNNs for data collection .


It produces more accurate data that can be considered evidence-based .


Despite persistent calls to measure the effectiveness of educational interventions on patient outcomes , few studies have been conducted .


Within musculoskeletal physiotherapy , the effects of postgraduate clinical mentoring on physiotherapist performance have been assessed , but the impact of this mentoring on patient outcomes remains unknown .


The objective of this trial is to assess the effectiveness of a work-based mentoring programme to facilitate physiotherapist clinical reasoning on patient outcomes in musculoskeletal physiotherapy .


A stepped wedge cluster randomised controlled trial ( CRCT ) has been designed to recruit a minimum of 12 senior physiotherapists who work in musculoskeletal outpatient departments of a large National Health Service ( NHS ) organization .


Participating physiotherapists will be randomised by cluster to receive the intervention at three time periods .


Patients will be blinded to whether their physiotherapist has received the intervention .


The primary outcome measure will be the Patient-Specific Functional Scale ; secondary outcome measures will include the EQ-5D , patient activation , patient satisfaction and physiotherapist performance .


Sample size considerations used published methods describing stepped wedge designs , conventional values of 0.80 for statistical power and 0.05 for statistical significance , and pragmatic groupings of 12 participating physiotherapists in three clusters .


Based on an intergroup difference of 1.0 on the PSFS with a standard deviation of 2.0 , 10 patients are required to complete outcome measures per physiotherapist , at time period 1 ( prior to intervention roll-out ) and at each of time periods 2 , 3 and 4 , giving a sample size of 480 patients .


To account for the potential loss to follow-up of 33 % , 720 sets of patient outcomes will be collected.All physiotherapist participants will receive 150 hours of mentored clinical practice as the intervention and usual in-service training as control .


Consecutive , consenting patients attending treatment by the participating physiotherapists during data collection periods will complete outcome measures at baseline , discharge and 12 months post-baseline .


The lead researcher will be blinded to the allocation of the physiotherapist when analyzing outcome data ; statistical analysis will involve classical linear models incorporating both an intervention effect and a random intercept term to reflect systematic differences among clusters .


Assigned 31 July 2012 : ISRCTN79599220 .


Walking and yoga have been independently evaluated for weight control ; however , there are very few studies comparing the 2 with randomization .


The present study compared the effects of 90 minutes/day for 15 days of supervised yoga or supervised walking on : ( i ) related biochemistry , ( ii ) anthropometric variables , ( iii ) body composition , ( iv ) postural stability , and ( v ) bilateral hand grip strength in overweight and obese persons .


Sixty-eight participants , of whom 5 were overweight ( BMI 25 kg/m2 ) and 63 were obese ( BMI 30 kg/m2 ; group mean age S.D. , 36.411.2 years ; 35 females ) , were randomized as 2 groups - ( i ) a yoga group and ( ii ) a walking group - given the same diet .


All differences were pre-post changes within each group .


Both groups showed a significant ( p < 0.05 ; repeated measures ANOVA , post-hoc analyses ) decrease in : BMI , waist circumference , hip circumference , lean mass , body water , and total cholesterol .


The yoga group increased serum leptin ( p < 0.01 ) and decreased LDL cholesterol ( p < 0.05 ) .


The walking group decreased serum adiponectin ( p < 0.05 ) and triglycerides ( p < 0.05 ) .


Both yoga and walking improved anthropometric variables and serum lipid profile in overweight and obese persons .


The possible implications are discussed .


Benvitimod is a newly synthesized non-steroidal small molecule , aimed at the treatment for psoriasis .


Several trials have demonstrated that benvitimod improves plaque psoriasis .


However , its maximum tolerated dose and pharmacokinetic characteristics have not been reported on .


The goals of this study were to evaluate the safety , tolerability and pharmacokinetics of benvitimod after topical administration in healthy subjects .


This phase I trial in healthy subjects was designed as a randomized , double-blind , placebo-controlled , ascending-dose study .


After screening and randomization , 56 volunteers received benvitimod ( 05-20 % ) or placebo cream once or twice daily .


Doses were escalated from 5 to 30mg daily in six cohorts .


Safety and tolerability were appraised by monitoring adverse events and laboratory parameters .


Benvitimod concentrations were measured using liquid chromatography-tandem-mass spectrometry .


Exposure to benvitimod did not result in electrocardiographic or clinical laboratory changes .


Doses up to 30mg were well tolerated .


All adverse events were mild .


Adverse effects at the application site were observed in subjects randomized to benvitimod 5mg q.d and b.i.d , but there were no observable dose effects in the dose-range evaluated .


Benvitimod was detected in fewer than 5 % of the plasma samples .


Benvitimod cream , at single doses of up to 30mg , is well tolerated by healthy subjects .


Following topical application , systemic absorption was negligible .


Currently available preparations for colonoscopy have low tolerability and may cause fluid and electrolyte shifts .


An alternative method of bowel cleansing is required .


Preparation of the gut using oral nutritional supplements ( ONS ) and rectal enema was tested as an alternative method of bowel cleansing .


During 2008-2012 , patients were randomized to oral nutritional supplements ( n = 27 ) for 5 days and rectal enema or polyethylene glycol ( PEG ) ( n = 23 ) prior to colonoscopy .


Blinded endoscopists rated the degree of bowel cleansing according to the Ottawa bowel preparation scale ( OBS ) ( primary outcome ) .


Tolerability of either preparation was also assessed ( ClinicalTrials.gov .


Identifier no : NCT00123456 ) .


Due to a high rate of bowel cleansing failure among patients receiving ONS , the study was interrupted prematurely .


Colonoscopies were incomplete due to stools in 6 of 27 patients in the ONS group compared to 1 of 23 in the PEG group ( ns ) .


The mean total OBS were 8.3 3.3 and 5.3 2.8 , respectively ( p = 0.002 ) .


Four patients ( 15 % ) in the ONS group and eight patients ( 35 % ) receiving PEG had an OBS score 4 ( good preparation ) ( ns ) .


ONS was better tolerated than PEG with more patients reporting acceptable taste ( 27 of 27 [ 100 % ] vs. 15 of 23 [ 65 % ] , p = 0.001 ) , and fewer reporting difficulties with the intake ( 0 of 27 [ 0 % ] vs. 10 of 23 [ 43 % ] , p < 0.001 ) and nausea ( 5 of 27 [ 19 % ] vs. 13 of 23 [ 57 % ] , p < 0.008 ) .


For routine use , ONS with enema instead of traditional preparation for colonoscopy with PEG can not be generally recommended .


To compare the efficacy and safety of a new porcine-derived pulmonary surfactant developed by Instituto Butantan with those of animal-derived surfactants commercially available in Brazil , regarding neonatal mortality and the major complications of prematurity in preterm newborns with birth weight up to 1500g and diagnosed with respiratory distress syndrome .


Neonates diagnosed with respiratory distress syndrome were randomized to receive either Butantan surfactant ( Butantan group ) or one of the following surfactants : Survanta or Curosurf .


Newborns receiving Survanta or Curosurf comprised the control group .


The main outcome measures were mortality rates at 72 hours and at 28 days of life ; the typical complications of prematurity as evaluated on the 28th day of life were defined as secundary outcomes .


No differences were observed between the Butantan ( n = 154 ) and control ( n = 173 ) groups in relation to birth weight , gestational age , sex , and prenatal use of corticosteroids , or in mortality rates both at 72 hours ( 14.19 % versus 14.12 % ; p = 0.98 ) and at 28 days ( 39.86 % versus 33.33 % ; p = 0.24 ) of life .


Higher 1 - and 5-minute Apgar scores were observed among control group newborns .


No differences were observed as regards the secondary outcomes , except for greater need for supplemental oxygen and a higher incidence of interstitial pulmonary emphysema in the Butantan group .


The mortality rates at 72 hours and 28 days of life and the incidence of major complications of prematurity were comparable to those found with the animal-derived surfactants commercially available in Brazil , showing the efficacy and safety of the new surfactant in the treatment of respiratory distress syndrome in newborns .


To explore the influence of cefodizime on CD4/CD8 and T helper 1 ( Th1 ) / Th2 cell ratios in peripheral blood of the senile patients with bacterial pneumonia .


Sixty-three senile patients with bacterial pneumonia were enrolled and divided into two groups randomly .


Patients in the control group ( n = 31 ) were given intravenous infusion of ceftriaxone sodium , and patients in the observation group ( n = 32 ) were given intravenous infusion of cefodizime .


The fasting venous blood was taken before and after treatment to detect CD4/CD8 and Th1/Th2 cell ratios with flow cytometry .


At the same time , the serum interleukin-2 ( IL-2 ) , interferon ( IFN - ) , IL-4 and IL-10 contents were also detected with ELISA .


Before treatment , there was no significant difference in the above indexes between the two groups .


After treatment , CD4 cells and Th1 cells of the observation group increased while Th2 cells decreased ; as a result , the CD4/CD8 and Th1/Th2 cell ratios of the observation group were significantly higher than those of the control group .


At the same time , serum IL-2 and IFN - contents of the observation group were significantly higher than those of the control group , while serum IL-4 and IL-10 contents were significantly lower than those of the control group .


Cefodizime can improve the cellular immune function and rectify CD4/CD8 and Th1/Th2 imbalance in peripheral blood of the senile patients with bacterial pneumonia .


The aim of this study was to evaluate the effects of radiotherapy plus concurrent weekly cisplatin chemotherapy on the postoperative recurrence of mediastinal lymph node metastases in esophageal cancer patients .


Ninety-eight patients were randomly enrolled to receive either three-dimensional conformal radiotherapy alone ( group A ) or concurrent chemoradiotherapy ( group B ) .


A radiation dose of 62-70 Gy/31 -35 fractions was delivered to the recurrent tumor .


Furthermore , the patients in group B simultaneously received weekly doses of cisplatin ( 30 mg/m ( 2 ) ) , and the survival outcomes and toxic effects were compared .


The response rate of group B ( 91.8 % ) was significantly greater than that of group A ( 73.5 % ) ( ( 2 ) = 5.765 , P = 0.016 ) .


The 1 - and 3-year survival rates of group B ( 85.7 % and 46.9 % , respectively ) were also greater than those of group A ( 69.4 % and 28.6 % , respectively ) .


However , there were no significant differences in the 5-year survival rates .


The numbers of patients who died of distant metastases in groups A and B were 13 ( 26.5 % ) and 5 ( 10.2 % ) , respectively ( ( 2 ) = 4.356 , P = 0.036 ) .


Acute radiation-related esophagitis and granulocytopenia in group B was frequent .


However , intergroup differences in terms of late toxicity were not significant .


Three-dimensional conformal radiotherapy ( 3DCRT ) is a practical and feasible technique to treat the recurrence of mediastinal lymph node metastases of postoperative esophageal cancer .


In addition , concurrent chemotherapy can increase local tumor control , decrease the distant metastasis rate , and increase the long-term survival rate .


No specific antiviral agent against hand foot and mouth disease ( HFMD ) is available for clinical practice today .


To evaluate the efficacy and safety of Jinzhen oral solution in treating uncomplicated HFMD .


In this randomized , double-blind , placebo-controlled trial , 399 children aged 1 to 7 years with laboratory confirmed HFMD were randomized to receive Jinzhen oral liquid or placebo 3 times daily for 7 days with a 3-day follow-up .


The primary outcomes were time to the first disappearance of oral ulcers and vesicles on hand or foot and time to the first normalization of temperature ( fever clearance ) .


There were 199 children enrolling into the Jinzhen group including 79 with fever and 200 into the placebo group including 93 with fever .


Jinzhen reduced the time to the first disappearance of oral ulcers and vesicles on hand or foot to 4.9 days ( 95 % CI , 4.6 to 5.2 days ) , compared with 5.7 days ( 95 % CI , 5.4 to 6.0 days ) in the placebo group ( P = 0.0036 ) .


The median time of fever clearance was shorter in the 79 children who received Jinzhen ( 43.41 hrs , 95 % CI , 37.05 to 49.76 ) than that in the 93 children who received placebo ( 54.92 hrs , 95 % CI , 48.16 to 61.68 ) ( P = 0.0161 ) .


Moreover , Jinzhen reduced the risk of symptoms by 28.5 % compared with placebo ( HR , 0.7150 , 95 % CI , 0.5719 to 0.8940 , P = 0.0032 ) .


More importantly , treatment failure rate was significantly lower in the Jinzhen group ( 8.04 % ) compared with that in the placebo group ( 15.00 % ) ( P = 0.0434 ) .


The incidence of serious adverse events did not differ significantly between the two groups ( 9 in Jinzhen group vs. 18 in placebo , P = 0.075 ) .


Children with HFMD may benefit from Jinzhen oral liquid treatment as compared with placebo .


Chinese Clinical Trial Registry ( http://www.chictr.org/en/ ) ChiCTR-TRC-10000937 .


This study examined overall changes in nicotine concentrations when using a popular e-cigarette and 18 mg/mL nicotine e-Juice , and it further explored effects of sex and flavorings on these concentrations .


We recruited nontreatment-seeking smokers who were willing to try e-cigarettes for 2 weeks and abstain from cigarette smoking .


Subjects were randomized to either menthol tobacco or non-menthol tobacco-flavored e-cigarette use for 7-10 days , and the next week they were crossed over to the other condition .


On the last day of e-cigarette use of each flavor , subjects completed a laboratory session in which they used the e-cigarette for 5 min ad libitum .


Nicotine concentrations were obtained 5 min before and 5 , 10 , 15 , 20 , and 30 min after the onset of e-cigarette use .


Twenty subjects completed at least 1 monitoring session .


Nicotine concentrations significantly increased from baseline to 5 min by 4 ng/mL at the first laboratory session ( p < .01 ) and by 5.1 ng/mL at the second laboratory session ( p < .01 ) .


Combining sessions , there were no main effects of sex or preferred flavor ( based on smoking history ) on changes in nicotine concentrations .


After adding preferred flavor , sex , and visit order to the model , there was a significant preferred flavor by sex interaction ( p < .01 ) , such that women who received nonpreferred flavors had lower nicotine concentrations and rated their e-cigarette as less likeable ( p < .01 ) .


We found nicotine concentrations significantly increase after e-cigarette use for 5 min , and flavor may impact nicotine concentrations with e-cigarette use in women .


Depression is a common and disabling condition .


In Chile , assistance is guaranteed by law through a national program for depression in primary care services , and there is evidence of effective treatment for depressed women .


However , there is a shortage of evidence-based treatments for depression in adolescents .


The incorporation of technology to expand therapeutic options is becoming more common .


This proposal aims to compare the efficacy of therapy that enhances traditional face-to-face cognitive-behavioral therapy ( CBT ) with a computer-based program versus usual care to treat depression in adolescents in primary care clinics in Santiago , Chile .


This is a two-arm , single-blind , randomized controlled trial with a target enrollment of 216 depressed adolescents between 15 and 19years of age , attending four primary care clinics in Santiago , Chile .


In the active arm , depressed adolescents will receive eight sessions of computer-assisted CBT , led by trained psychologists on a weekly basis .


In the control arm , depressed adolescents will receive treatment as usual from the primary care centers .


Mean depression scores and indicators of dysfunctional thoughts , problem-solving strategies , and health-related quality of life will be measured at baseline and four and six months after randomization .


As far as we know , this is the first randomized controlled trial of a computer-assisted CBT intervention for depressed adolescents in a Latin American country .


Clinical Trials : NCT01862913 .


Fibromyalgia ( FM ) is a disease that causes widespread pain and increased sensitivity to pain because of a dysfunction in the central nervous system .


This study investigated the effect of music combined with vibration on acupuncture points for the treatment of FM .


A total of 120 patients with FM were allocated randomly to four groups ( 30 patients each ) .


One group listened to a sequence of Bach 's compositions .


The second group was subjected to vibratory stimuli on a combination of acupuncture points on the skin .


The third group ( complete ) underwent both procedures in a simultaneous and synchronized manner , with inclusion of binaural beats .


The fourth group ( control ) received no stimulation .


The participants underwent the experimental procedure during five sessions performed on alternate days .


They were assessed by the Fibromyalgia Impact Questionnaire ( FIQ ) and the Health Assessment Questionnaire ( HAQ ) before the first session and after the last session ( 20 days ) .


All groups showed a significant improvement in FIQ and HAQ scores at the evaluation after the intervention .


The complete group exhibited the best result on both the FIQ and HAQ ( p < 0.001 ) , and the improvement in HAQ score was significant ( p < 0.004 ) .


The results suggest that the placebo effect in FM may be substantial .


However , comparison between groups revealed that the complete group had the greatest reduction in both FIQ and HAQ , with a significant improvement in HAQ , suggesting that the combined use of music and vibration exerts a greater effect on FM symptoms .


To determine whether the extruded irrigation solution bag during passage of rigid cystoscope will reduce the patient 's discomfort .


In the study , 378 male patients undergoing rigid cystoscopies were randomized into `` Institute of Urology Peking University ( IUPU ) '' technique group ( n = 193 ) and routine manipulation group ( n = 185 ) .


All the patients had received 10 mL oxybuprocaine gel before manipulation .


In the IUPU technique group , irrigation solution bag was connected with cystoscope sheath and obturator .


As the scope passed through the bulbar urethra , a nurse was instructed to extrude the irrigating fluid bag .


A 10-point visual analog pain scale assessment was completed by the patient after the procedure .


The visual analog pain score was 2 ( 1-2 ) in the IUPU technique group and 4 ( 3-6 ) in the routine manipulation group ( P < 0.001 , Mann-Whitney U test ) .


All the procedure indications had no effect on the findings .


This study has shown that a simple IUPU technique can significantly reduce the patient 's discomfort during outpatient rigid cystoscopy .


We strongly recommend this technique for all male patients undergoing rigid cystoscopy .


Contingency management ( CM ) treatment is effective for treating cocaine dependence but further mechanistic studies of its efficacy are warranted .


This study aimed to determine whether : ( a ) higher vs. lower predictable money amounts ( $ 3 vs. $ 1 ; analogs of standard voucher-based CM ) increase cocaine demand elasticity ; and ( b ) probabilistic amounts matched for expected value with the $ 3-predictable amount ( 50 % chance of $ 6 ; 25 % chance of $ 12 ; and 12.5 % chance of $ 24 ; analogs of prize CM ) similarly affect cocaine choice .


Each of 15 cocaine-dependent participants first completed a qualifying session to ensure that intranasal cocaine functioned as a reinforcer , then completed a 10-session , within-subject , randomized crossover study .


During each of the 10 sessions , the participant responded on a progressive ratio schedule to earn units of cocaine ( 5-mg or 10-mg ) and/or money ( five monetary conditions above ) .


During the reinforcement qualifying session ( 10-mg vs. 0-mg units ; no money alternative ) , cocaine choice was high .


The $ 3-predictable amount significantly decreased cocaine choice relative to both the $ 1-predictable amount and the qualifying session .


Cocaine-choices in the probabilistic conditions were similar to the $ 3 predictable condition .


These findings indicate that CM interventions targeted at reducing cocaine self-administration are more likely to succeed with higher value non-drug reinforcement .


The purpose of this study was to evaluate associations between prescription drug misuse ( PDM ) and sexual risk behaviors ( SRBs ) among adolescents and emerging adults .


In a hospital emergency department , 2,127 sexually active 14 - to 20-year-olds ( 61 % female ) reported on past-year alcohol use severity ( using the Alcohol Use Disorders Identification Test-consumption [ AUDIT-C ] ) , cannabis use , PDM ( n = 422 ) , and SRBs ( inconsistent condom use , multiple partners , intercourse following alcohol/other drug use ) .


Bivariately , AUDIT-C score , cannabis use , and PDM of stimulants , opioids , and sedatives were positively associated with each SRB .


Because many participants reported PDM for multiple drug classes ( i.e. , sedatives , stimulants , opioids ) , participants were categorized as ( a ) no PDM ( n = 1,705 ) , ( b ) PDM of one class ( n = 251 ) , ( c ) PDM of two classes ( n = 90 ) , or ( d ) PDM of three classes ( n = 81 ) .


Three hierarchical logistic regression models evaluated the associations of number of classes of PDM with SRBs separately , after accounting for demographics ( age , gender , race ) , AUDIT-C score , and cannabis use .


Adding PDM statistically improved each model beyond what was accounted for by demographics , alcohol , and cannabis use .


For inconsistent condom use and substance use before sex , PDM of one , two , or three classes was significantly associated with increased odds of these SRBs .


PDM of two or three classes was associated with increased odds of reporting multiple partners .


Findings suggest that PDM , especially poly-PDM , may be a pertinent risk factor for SRBs among youth .


Event-based research could further evaluate how PDM , as well as other substance use , is related to SRBs at the event level in order to inform interventions .


Synthetic colloids are often used during fluid resuscitation and affect coagulation .


To compare the effects of an isotonic crystalloid and synthetic colloid on coagulation in healthy dogs and dogs with systemic inflammation .


Sixteen adult purpose-bred Beagles .


Randomized , placebo-controlled , blinded study .


Dogs were randomized into one of two groups receiving fluid resuscitation with either 40 mL/kg IV 0.9 % NaCl or tetrastarch after administration of lipopolysaccharide or an equal volume of placebo .


After a 14-day washout period , the study was repeated such that dogs received the opposite treatment ( LPS or placebo ) but the same resuscitation fluid .


Blood samples were collected at 0 , 1 , 2 , 4 , and 24 hours for measurement of coagulation variables .


Administration of either fluid to healthy dogs and dogs with systemic inflammation resulted in similar increases in prothrombin time and activated clotting time .


In comparison to saline administration , tetrastarch administration resulted in significantly decreased R ( P = .017 ) in healthy dogs , as well as significantly increased activated partial thromboplastin time ( P .016 ) , CL30 % ( P .016 ) , and K ( P < .001 ) and significantly decreased platelet count ( P = .019 ) , ( P .001 ) , MA ( P < .001 ) , and von Willebrand factor antigen ( P < .001 ) and collagen binding activity ( P .003 ) in both healthy dogs and dogs with systemic inflammation .


Tetrastarch bolus administration to dogs with systemic inflammation resulted in a transient hypocoagulability characterized by a prolonged activated partial thromboplastin time , decreased clot formation speed and clot strength , and acquired type 1 von Willebrand disease .


To evaluate the reduction in phantom pain and sensation with combined training of progressive muscle relaxation , mental imagery , and phantom exercises .


Randomized controlled prospective trial with 2 parallel groups .


Amputee unit of a rehabilitation hospital .


Subjects with unilateral lower limb amputation ( N = 51 ) with phantom limb pain ( PLP ) and/or phantom limb sensation ( PLS ) .


The experimental group performed combined training of progressive muscle relaxation , mental imagery , and phantom exercises 2 times/wk for 4 weeks , whereas the control group had the same amount of physical therapy dedicated to the residual limb .


No pharmacological intervention was initiated during the trial period .


The Prosthesis Evaluation Questionnaire and the Brief Pain Inventory were used to evaluate changes over time in different aspects ( intensity , rate , duration , and bother ) of PLS and PLP .


Blind evaluations were performed before and after treatment and after 1-month follow-up .


The experimental group showed a significant decrease over time in all the Prosthesis Evaluation Questionnaire domains ( in terms of both PLS and PLP ; P < .04 for both ) and the Brief Pain Inventory ( P < .03 ) .


No statistically significant changes were observed in the control group .


Between-group analyses showed a significant reduction in intensity ( average and worst pain ) and bother of PLP and rate and bother of PLS at follow-up evaluation , 1 month after the end of the treatment .


Combined training of progressive muscle relaxation , mental imagery , and modified phantom exercises should be taken into account as a valuable technique to reduce phantom limb pain and sensation .


Anxiety among patients in a pediatric emergency department ( PED ) can be significant , but often goes unaddressed .


Our aim was to determine whether exposure to Child Life ( CL ) or hospital clowning ( HC ) can reduce anxiety in children presenting to a PED .


Patients were randomized to CL , HC , or control and assessed upon entry to examination room ( T1 ) , before physician arrival ( T2 ) , and during physician examination ( T3 ) , using the modified Yale Preoperative Anxiety Scale ( m-YPAS ) .


CL and HC interventions occurred for 5 to 10 min before physician entry .


Effects were analyzed using mixed analysis of variance .


m-YPAS scores ranged from 23 to 59 , with a higher score indicating increased anxiety .


Mixed analysis of variance on the study sample ( n = 113 ) showed a significant interaction between groups ( CL , HC , control ) and time ( p = 0.02 ) .


Additional analyses indicated effect of group only at T2 ( CL : mean = 23.8 ; 95 % confidence interval [ CI ] 23.2-24 .5 ; HC : mean 25.2 ; 95 % CI 24.2-26 .2 ; control : mean = 26.1 ; 95 % CI 24.2-27 .9 ; p = .02 ) .


Subanalysis of patients with T1 m-YPAS score 28 ( n = 56 ) showed a significant interaction between group and time ( p = 0.01 ) .


Additional analysis showed effect of group only at T2 ( CL : mean 24.4 ; 95 % CI 23.3-25 .6 ; HC : mean 27.0 ; 95 % CI 25.2-28 .7 ; control : mean 29.2 ; 95 % CI 25.6-32 .7 ; p = 0.003 ) .


CL services can reduce state anxiety for patients presenting to a PED with heightened anxiety at baseline .


This reduction occurred immediately after CL intervention , but was not observed in patients exposed to HC or during physician examination .


Minimizing hemodynamic changes during the peri-intubation period is a concern for anesthesiologists .


We investigated the effect of lidocaine sprayed on the laryngoscope blade and trachea on hemodynamics during direct laryngoscopic intubation .


Seventy-two patients were randomly allocated to one of four groups : 10 % lidocaine was sprayed either on the laryngoscope blade ( group L ) , on the trachea ( group V ) , or on the laryngoscope blade and the trachea ( group LV ) .


No lidocaine was used in group C. Anesthesia was induced in all patients with remifentanil ( effect site concentration : 4.0 ng/ml ) and propofol ( effect site concentration 4.0 g/ml ) continuous infusion using a target control infusion ( TCI ) device .


Mean arterial pressure ( MAP ) and heart rate ( HR ) were recorded during the peri-intubation period .


Changes in MAP and HR over time were markedly different among the four groups ( P < 0.05 ) .


MAP at 1 min post-intubation was significantly lower in groups L , V , and LV than in group C ( 86.1 12.7 , 85.3 12.6 , and 83.7 13.1 vs. 106.3 22.9 mmHg , P < 0.01 ) .


Maximum MAP values were lower in groups L and LV than in group C ( P < 0.05 ) .


HRs at 1 , 2 , and 3 min post-intubation were lower in group LV than in group C ( 70.4 9.0 vs. 84.2 15.3 ; 64.0 8.1 vs. 79.2 15.4 ; 61.6 8.3 vs. 77.2 14.5 beats/min , P < 0.01 , respectively ) .


Lidocaine sprayed on the laryngoscope blade and/or trachea reduced the hemodynamic response to laryngoscopic intubation during the post-intubation period following anesthetic induction with remifentanil and propofol using a TCI device .


To examine basic and everyday cognitive predictors of older adults ' self-reported instrumental activities of daily living ( IADL ) .


Basic and everyday cognitive predictors of self-reported IADL were examined in a sample of healthy , community-dwelling older adults ( n = 698 ) assessed over 5 years of measurement .


Multilevel longitudinal analyses revealed linear and quadratic change trends for self-reported IADL function , with steeper declines at higher ages .


Within-person , when participants exhibited lower cognitive performance , they also reported more IADL impairment .


Everyday cognition remained a significant unique predictor of self-reported IADL after controlling for attrition , resampling effects , temporal gradients , and baseline levels and changes in demographic , sensory , functional , and basic cognitive measures .


By itself , everyday cognition appears to be an important predictor of self-reported IADL , and maintains a unique predictive contribution after many covariates are controlled .


Future research should consider the inclusion of everyday cognitive measures in functional assessment batteries .


Post-operative nasogastric intubation after emergency laparotomy is a common practice in many centers , with the intent of hastening the return of bowel function , relieving gastrointestinal discomfort , reducing various post-operative complications and reducing hospital stay .


However , bowel rest and gastric decompression have been re-examined in the light of more recent data .


Many studies and meta-analyses over the last 50 years have challenged the routine use of nasogastric tubes after laparotomy .


The objective of this study is to evaluate the need for routine nasogastric decompression after emergency laparotomy .


A prospective , randomized controlled trial was conducted for 12 months ( May 1 , 2007 to Apr 30 , 2008 ) in the Department of Surgery , Tribhuvan University Teaching Hospital , after ethical approval .


Patients were enrolled as per criteria ( Box 1 ) , and subsequently allocated by simple randomization into two groups : Group 1 and Group 2 .


Patients undergoing emergency laparotomy for perforation peritonitis , intestinal obstruction and abdominal trauma were randomized to two groups - with or without nasogastric tube after surgery .


Gastric upset , return of bowel function and postoperative complications were compared .


Total of 115 patients met the inclusion criteria .


There was no statistically significant difference in the occurrence of gastric upset ( P : 0.38 ) , wound complications ( P : 0.30 ) , respiratory complications ( P : 0.30 ) and anastomotic leak ( P : 0.64 ) between two groups .


Bowel function returned in comparable times in both groups ( correlation coefficient : 0.14 ; P : 0.54 ) .


Nasogastric tube had to be reinserted in three patients in the group with nasogastric decompression postoperatively , and four in the group without ( P : 0.43 ) .


Thus , routine nasogastric decompression neither prevented the development of gastrointestinal discomfort nor precluded the need for tube replacement once it was discontinued .


For every patient who required post-operative nasogastric decompression , at least 14 patients were spared one .


Mean hospital stay was significantly more in the decompressed group ( 7.52 days ; correlation coefficient : 0.22 ; P < 0.05 ) .


This study has shown that the prophylactic nasogastric decompression following emergency laparotomy is ineffective in achieving any of the intended goals .


complications ; decompression ; emergency laparotomy ; flatus ; nasogastric tube ; prophylactic .


Childhood obesity rates in the U.S. have reached epidemic proportions , and an urgent need remains to identify evidence-based strategies for prevention and treatment .


Multi-level , multi-component interventions are needed due to the multi-factorial nature of obesity , and its proven links to both the social and built environment .


However , there are huge gaps in the literature related to doing these kinds of interventions among low-income , urban , minority groups .


The B'More Healthy Communities for Kids ( BHCK ) intervention is a multi-level , multi-component intervention , targeting low-income African American youth ages 10-14 and their families in Baltimore , Maryland .


This intervention prevents childhood obesity by working at multiple levels of the food and social environments to increase access to , demand for , and consumption of healthier foods .


BHCK works to create systems-level change by partnering with city policy-makers , multiple levels of the food environment ( wholesalers , corner stores , carryout restaurants ) , and the social environment ( peers and families ) .


In addition , extensive evaluation will be conducted at each level of the intervention to assess intervention effectiveness via both process and impact measures .


This project is novel in multiple ways , including : the inclusion of stakeholders at multiple levels ( policy , institutional , and at multiple levels of the food system ) ; that it uses novel computational modeling methodologies to engage policy makers and guide informed decisions of intervention effectiveness ; it emphasizes both the built environment ( intervening with food sources ) and the social environment ( intervening with families and peers ) .


The design of the intervention and the evaluation plan of the BHCK project are documented here .


NCT02181010 ( July 2 , 2014 ) .


The open Burch colposuspension , first described in 1961 had been widely employed for the surgical treatment of women with stress urinary incontinence ( SUI ) caused by urethral hypermobility .


We evaluated the long-term efficacy of laparoscopic Burch colposuspension ( LBC ) for SUI in women .


A randomized prospective trial was conducted from September 2010 to January 2013 .


The extraperitoneal laparoscopic Burch colposuspension was performed by an operator on 96 women , mean age was 54,3 3,7 years all of whom suffered from SUI or mixed urinary incontinence .


Patients completed a self-administered the Short Form-36 ( SF-36 ) , the Physical Component Summary ( PCS ) and Mental Component Summary ( MCS ) , the Short Urinary Distress Inventory ( SUDI ) and Short Incontinence Impact Questionnaire ( SIIQ ) .


at both baseline and follow up ( 6 weeks , 6 months , 18 months postoperatively ) .


The Genito-Urinary Treatment Satisfaction Scale ( GUTSS ) was used to assess satisfaction with surgery .


After follow up was recorded an improvement of questionnaries scores .


The general health score is improved after surgery ( 2,60 1.02 versus 2,76 1.06 ) with p = 0.09 .


The PCS baseline score is 46.29 10.95 versus 49.54 10.41 after treatment with p = 0.01 , so there was a significant baseline to follow up improvement .


The MCS improved also , infact baseline score is 42.19 12.57 versus 42.70 13.03 with p = 0.87 .


The SUDI baseline score is 50.22 20.73 versus 23.92 17.90 , while SIIQ score is 49.98 23.90 versus 31.40 23.83 with p < 0.01 .


In both questionnaires there is an improvement .


Satisfaction with treatment outcomes from the GUTSS at 6-month follow up is 29.5 6.3 with p = 0.46 .


The LBC has significant advantages , without any apparent compromise in short-term and long term outcomes .


The purpose of this study was to compare the effects of thoracic thrust manipulation vs thoracic non-thrust mobilization in patients with bilateral chronic mechanical neck pain on pressure pain sensitivity and neck pain intensity .


Fifty-two patients ( 58 % were female ) were randomly assigned to a thoracic spine thrust manipulation group or of thoracic non-thrust mobilization group .


Pressure pain thresholds ( PPTs ) over C5-C6 zygapophyseal joint , second metacarpal , and tibialis anterior muscle and neck pain intensity ( 11-point Numerical Pain Rate Scale ) were collected at baseline and 10 minutes after the intervention by an assessor blinded to group allocation .


Mixed-model analyses of variance ( ANOVAs ) were used to examine the effects of the treatment on each outcome .


The primary analysis was the group * time interaction .


No significant interactions were found with the mixed-model ANOVAs for any PPT ( C5-C6 : P > .252 ; second metacarpal : P > .452 ; tibialis anterior : P > .273 ) : both groups exhibited similar increases in PPT ( all , P < .01 ) , but within-group and between-group effect sizes were small ( standardized mean score difference [ SMD ] < 0.22 ) .


The ANOVA found that patients receiving thoracic spine thrust manipulation experienced a greater decrease in neck pain ( between-group mean difference : 1.4 ; 95 % confidence interval , 0.8-2 .1 ) than did those receiving thoracic spine non-thrust mobilization ( P < .001 ) .


Within-group effect sizes were large for both groups ( SMD > 2.1 ) , and between-group effect size was also large ( SMD = 1.3 ) in favor of the manipulative group .


The results of this randomized clinical trial suggest that thoracic thrust manipulation and non-thrust mobilization induce similar changes in widespread PPT in individuals with mechanical neck pain ; however , the changes were clinically small .


We also found that thoracic thrust manipulation was more effective than thoracic non-thrust mobilization for decreasing intensity of neck pain for patients with bilateral chronic mechanical neck pain .


To determine whether a single session of motivational interviewing ( MI ) for feedback of a child 's overweight status promotes engagement in treatment following screening .


One thousand ninety-three children aged 4-8 years were recruited through primary and secondary care to attend health screening , including assessment of parenting practices and motivation ( questionnaire ) .


Families with normal-weight children were informed about their child 's weight but had no further involvement .


Parents of overweight ( body mass index 85th percentile ) children ( n = 271 ) were randomised to receive weight feedback via MI or best practice care ( BPC ) using a traffic light concept to indicate degree of health risk .


Follow-up interviews were held 2 weeks later to examine intervention uptake , changes to motivation and behaviour , and parental response to feedback .


Recruitment into the intervention was high ( 76 % ) and not altered by feedback condition ( percentage difference 6.6 ( 95 % confidence interval -2.9 , 16.0 ) .


High scores on the Health Care Climate Questionnaire ( rating of the interviewer ) indicated satisfaction with how the information was provided to parents .


No differences were observed in multiple indicators of harm .


However , self-determined motivation for healthy life-styles was significantly higher in the MI condition at follow-up ( 0.18 : 0.00 , 0.35 ) , after only a single session of MI .


MI and BPC were both successful in encouraging parents to participate in a family-based intervention , with MI offering little significant benefit over BPC .


A traffic light approach to weight feedback is a suitable way of providing sensitive information to parents not expecting such news .


The most common form of maturity-onset diabetes of the young ( MODY ) , hepatocyte nuclear factor 1 ( HNF1A diabetes : MODY3 ) is often treated with sulfonylureas that confer a high risk of hypoglycemia .


We evaluated treatment with GLP-1 receptor agonists ( GLP-1RAs ) in patients with HNF1A diabetes .


Sixteen patients with HNF1A diabetes ( 8 women ; mean age 39 years [ range 23-67 years ] ; BMI 24.9 0.5 kg/m ( 2 ) [ mean SEM ] ; fasting plasma glucose [ FPG ] 9.9 0.9 mmol/L ; HbA1c 6.4 0.2 % [ 47 3 mmol/mol ] ) received 6 weeks of treatment with a GLP-1RA ( liraglutide ) and placebo ( tablets ) , as well as a sulfonylurea ( glimepiride ) and placebo ( injections ) , in randomized order , in a double-blind , crossover trial .


Glimepiride was up-titrated once weekly in a treat-to-target manner ; liraglutide was up-titrated once weekly to 1.8 mg once daily .


At baseline and at the end of each treatment period a standardized liquid meal test was performed , including a 30-min light bicycle test .


FPG decreased during the treatment periods ( -1.6 0.5 mmol/L liraglutide [ P = 0.012 ] and -2.8 0.7 mmol/L glimepiride [ P = 0.003 ] ) , with no difference between treatments ( P = 0.624 ) .


Postprandial plasma glucose ( PG ) responses ( total area under the curve ) were lower with both glimepiride ( 2,136 292 min mmol/L ) and liraglutide ( 2,624 340 min mmol/L ) compared with baseline ( 3,127 291 min mmol/L ; P < 0.001 , glimepiride ; P = 0.017 , liraglutide ) , with no difference between treatments ( P = 0.121 ) .


Eighteen episodes of hypoglycemia ( PG 3.9 mmol/L ) occurred during glimepiride treatment and one during liraglutide treatment .


Six weeks of treatment with glimepiride or liraglutide lowered FPG and postprandial glucose excursions in patients with HNF1A diabetes .


The glucose-lowering effect was greater with glimepiride at the expense of a higher risk of exclusively mild hypoglycemia .


Our aim was to assess the effects of the cholesteryl ester transfer protein ( CETP ) inhibitor anacetrapib and atorvastatin , both as monotherapy and in combination , on particle concentrations of low-density lipoproteins ( LDL ) , very low-density lipoproteins ( VLDL ) , and intermediate-density lipoproteins in dyslipidemic patients .


Although increases in high-density lipoproteins with CETP inhibition are well-documented , effects on atherogenic lipoprotein particle subclasses in dyslipidemic patients have not been extensively characterized .


Ion mobility was performed on stored plasma samples collected from patients before and after treatment with anacetrapib alone ( 150 and 300 mg/d ) or in combination with atorvastatin ( 20 mg/d ) in a previously conducted 8-week phase IIb study .


Anacetrapib produced significant placebo-adjusted reductions of total LDL particles and all subfractions except for increases in very small LDL 4a and 4b .


Atorvastatin reduced all LDL subfractions except LDL 4b .


Results were generally additive for anacetrapib + atorvastatin .


For patients treated with anacetrapib , the placebo-adjusted reduction in LDL 3a was attenuated and there was an increase in LDL 3b and 4a for those with low vs high triglyceride ( TG ) levels .


For the atorvastatin alone vs placebo treatment comparison , there were small reductions in LDL 3a , 3b , and 4a for those with low vs high TG levels .


Anacetrapib and atorvastatin produced similar reductions from baseline in total LDL particles , but did not have comparable effects on all LDL particle subfractions , and neither drug reduced the smallest LDL 4b particles .


The clinical significance of these changes and the differential effects on very small LDL 4a in patients with higher vs lower TG remain to be determined ( clinicaltrials.gov , NCT00325455 ) .


Rituximab could be an effective treatment for childhood-onset , complicated , frequently relapsing nephrotic syndrome ( FRNS ) and steroid-dependent nephrotic syndrome ( SDNS ) .


We investigated the efficacy and safety of rituximab in patients with high disease activity .


We did a multicentre , double-blind , randomised , placebo-controlled trial at nine centres in Japan .


We screened patients aged 2 years or older experiencing a relapse of FRNS or SDNS , which had originally been diagnosed as nephrotic syndrome when aged 1-18 years .


Patients with complicated FRNS or SDNS who met all other criteria were eligible for inclusion after remission of the relapse at screening .


We used a computer-generated sequence to randomly assign patients ( 1:1 ) to receive rituximab ( 375 mg/m ( 2 ) ) or placebo once weekly for 4 weeks , with age , institution , treatment history , and the intervals between the previous three relapses as adjustment factors .


Patients , guardians , caregivers , physicians , and individuals assessing outcomes were masked to assignments .


All patients received standard steroid treatment for the relapse at screening and stopped taking immunosuppressive agents by 169 days after randomisation .


Patients were followed up for 1 year .


The primary endpoint was the relapse-free period .


Safety endpoints were frequency and severity of adverse events .


Patients who received their assigned intervention were included in analyses .


This trial is registered with the University Hospital Medical Information Network clinical trials registry , number UMIN000001405 .


Patients were centrally registered between Nov 13 , 2008 , and May 19 , 2010 .


Of 52 patients who underwent randomisation , 48 received the assigned intervention ( 24 were given rituximab and 24 placebo ) .


The median relapse-free period was significantly longer in the rituximab group ( 267 days , 95 % CI 223-374 ) than in the placebo group ( 101 days , 70-155 ; hazard ratio : 027 , 014-053 ; p < 00001 ) .


Ten patients ( 42 % ) in the rituximab group and six ( 25 % ) in the placebo group had at least one serious adverse event ( p = 036 ) .


Rituximab is an effective and safe treatment for childhood-onset , complicated FRNS and SDNS .


Japanese Ministry of Health , Labour and Welfare .


Increased physical activity is associated with decreased risk of several types of cancer , but underlying mechanisms are poorly understood .


Angiogenesis , in which new blood vessels are formed , is common to adipose tissue formation/remodeling and tumor vascularization .


We examined effects of a 12-month 45 minutes/day , 5 days/week moderate-intensity aerobic exercise intervention on four serum markers of angiogenesis in 173 sedentary , overweight , postmenopausal women , 50 to 75 years , randomized to intervention versus stretching control .


Circulating levels of positive regulators of angiogenesis [ VEGF , osteopontin ( OPN ) , plasminogen activator inhibitor-1 ( PAI-1 ) ] , and the negative regulator pigment epithelium-derived factor ( PEDF ) , were measured by immunoassay at baseline and 12 months .


Changes were compared using generalized estimating equations , adjusting for baseline levels of analytes and body mass index ( BMI ) .


VEGF , OPN , or PAI-1 levels did not differ by intervention arm .


Participants randomized to exercise significantly reduced PEDF ( -3.7 % ) versus controls ( +3.0 % ; P = 0.009 ) .


Reductions in fat mass were significantly associated with reductions in PAI-1 ( Ptrend = 0.03 ; Ptrend = 0.02 ) and PEDF ( Ptrend = 0.002 ; Ptrend = 0.01 ) compared with controls , or to those who gained any fat mass respectively .


There was a significant association between decreases in VO2max , and increased reductions in PEDF ( Ptrend = 0.03 ) , compared with participants who increased their level of fitness .


Fat loss reduces circulating PAI-1 and PEDF .


Changes in VO2max are associated with alterations in PEDF , but these associations are complex .


Unexpected reductions in PEDF with decreasing fat mass , and with decreasing VO2max , warrant further study , including examining the effects of different types and intensities of exercise ; and role of dietary weight-loss with and without exercise .


Growth differentiation factor 15 ( GDF-15 ) , high-sensitivity troponin , and N-terminal pro-brain natriuretic peptide levels are predictive of death and cardiovascular events in healthy elderly subjects , patients with acute coronary syndrome , and patients with heart failure .


High-sensitivity troponin I and N-terminal pro-brain natriuretic peptide are also prognostic in patients with atrial fibrillation .


We evaluated the prognostic value of GDF-15 alone and in addition to clinical characteristics and other biomarkers in patients with atrial fibrillation .


The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ( ARISTOTLE ) trial randomized 18201 patients with atrial fibrillation to apixaban or warfarin .


Biomarkers were measured at randomization in 14798 patients .


Efficacy and safety outcomes during 1.9 years of follow-up were compared across quartiles of GDF-15 by use of Cox analyses adjusted for clinical characteristics , randomized treatment , and other biomarkers .


The GDF-15 level showed a median of 1383 ng/L ( interquartile range , 977-2052 ng/L ) .


Annual rates of stroke or systemic embolism ranged from 0.9 % to 2.03 % ( P < 0.001 ) ; of major bleeding , from 1.22 % to 4.53 % ( P < 0.001 ) ; and of mortality , from 1.34 % to 7.19 % ( P < 0.001 ) in the lowest compared with the highest GDF-15 quartile .


The prognostic information provided by GDF-15 was independent of clinical characteristics and clinical risk scores .


Adjustment for the other cardiac biomarkers attenuated the prognostic value for stroke , whereas the prognostic value for mortality and major bleeding remained .


Apixaban consistently reduced stroke , mortality , and bleeding , regardless of GDF-15 levels .


GDF-15 is a risk factor for major bleeding , mortality , and stroke in atrial fibrillation .


The prognostic value for major bleeding and death remained even in the presence of N-terminal pro-brain natriuretic peptide and high-sensitivity troponin I.


http://www.clinicaltrials.gov .


Unique identifier : NCT00412984 .


To assess the effectiveness of behavioural management in the treatment of migraine among adult patients .


The randomised control trial was conducted from August 2011 to August 2012 at the Aga Khan University Hospital , Karachi , in which adult patients aged 18-65 years were recruited with diagnosis of migraine from five outpatient sites .


The patients were randomised into 2 equal groups .


The controls were given pharmacological treatment , while the cases were given a structured behavioural management and pharmacological treatment .


Primary outcome was the change in frequency of migraine attacks .


Secondary outcome included change in severity of migraine and effect on the quality of life .


SPSS 19 was used for statistical analysis .


Of the 90 subjects in the study , 72 ( 80 % ) were female .


A significant reduction in the average frequency of migraine attacks was observed from baseline up to 4 weeks ( p < 0.001 ) but no difference in the mean migraine attacks was observed in the two groups ( p < 0.945 ) .


In the average score of severity of pain , significant reduction was observed for time ( p < 0.001 ) as well as for the intervention status ( p < 0.034 ) .


There was no significant difference ( p < 0.450 ) between treatment type and duration of migraine , but a significantly better quality of life ( p < 0.001 ) was observed in the trial group compared to the controls .


There was significant decrease in frequency , severity and duration of migraine attacks in the trial group compared to the control group .


The quality of life also showed improvement in the trial group .


Physical activity is one of the core components in cardiac rehabilitation and secondary prevention programs .


This study investigated the effect of an intervention based on the health action process approach ( HAPA ) together with family support in the maintenance of physical activity and exercise capacity in coronary heart disease after discharge from rehabilitation .


In this randomized controlled trial , 96 patients with coronary heart disease were randomly assigned to control and intervention groups at the end of a rehabilitation program at Afshar Hospital , Yazd , Iran .


HAPA Constructs and family support using a self-reported questionnaire and maximal oxygen uptake through a treadmill exercise test were measured prior to and 4 months after the intervention .


HAPA-based intervention together with family support increased scores of HAPA constructs and family support in the intervention group compared with the control group .


The results showed that physical activity and exercise capacity in the intervention group was significantly higher than the control group after the intervention .


HAPA-based intervention together with family support can be a useful tool for maintenance of physical activity and exercise capacity in coronary heart disease .


To observe the physiological and psychological effects of Chinese traditional healthcare exercises ( CTHE ) on the adolescents .


A total of 136 healthy students of junior school were recruited and randomly divided into the test group ( 68 cases ) and the control group ( 68 cases ) .


The subjects in the test group practiced CTHE , while those in the control group did `` the 8th radio calisthenics '' , an official recommended calisthenics for promoting healthcare in China , 3 times a week , and 7 weeks practicing overall .


The general body function examination and the meridian energy detection system were used to determine the effects of the two groups .


( 1 ) After exercise , the chest circumference and heart rate were increased significantly ( P < 0.01 ) , and both the systolic pressure ( SP ) and diastolic pressure ( DP ) were decreased significantly ( P < 0.01 ) , while the weight had no significant change ( P > 0.05 ) in the test group .


In the control group , the chest circumference , the SP and DP had no significant improvement ( P > 0.05 ) , while the heart rate was significantly increased and the weight was significantly decreased ( P < 0.01 ) .


( 2 ) The test group achieved significant positive changes in the performance status , state of mind and fatigue index ( P < 0.01 or P < 0.05 ) , while the control group only achieved a significant positive change in performance status ( P < 0.01 ) , and a negative significant decrease in the autonomic nerve function ( P < 0.05 ) .


Junior school students would get physiological and psychological benefit from practicing CTHE , and which is suitable for them to practice .


The relationships between cerebrovascular lesions visible on imaging and cognition are complex .


We explored the possibility that the cerebral cortical volume mediated these relationships .


Total of 1906 nondemented participants ( 59 % women ; 25 % African-American ; mean age , 76.6 years ) in the Atherosclerosis Risk in Communities ( ARIC ) study underwent cognitive assessments , risk factor assessments , and quantitative MRI for white matter hyperintensities ( WMH ) and infarcts .


The Freesurfer imaging analysis pipeline was used to determine regional cerebral volumes .


We examined the associations of cognitive domain outcomes with cerebral volumes ( hippocampus and separate groups of posterior and frontal cortical regions of interest ) and cerebrovascular imaging features ( presence of large or small cortical/subcortical infarcts and WMH volume ) .


We performed mediation pathway analyses to assess the hypothesis that hippocampal and cortical volumes mediated the associations between cerebrovascular imaging features and cognition .


In unmediated analyses , WMH and infarcts were both associated with worse psychomotor speed/executive function .


In mediation analyses , WMH and infarct associations on psychomotor speed/executive function were significantly attenuated , but not abolished , by the inclusion of the posterior cortical regions of interest volume in the models , and the infarcts on psychomotor speed/executive function association were attenuated , but not abolished , by inclusion of the frontal cortical regions of interest volume .


Both WMH and infarcts were associated with cortical volume , and both lesions were also associated with cognitive performance , implying shared pathophysiological mechanisms .


Although cross-sectional , our findings suggest that WMH and infarcts could be proxies for clinically covert processes that directly damage cortical regions .


Microinfarcts are 1 candidate for such a clinically covert process .


Although white matter hyperintensities ( WMHs ) are associated with the risk for Alzheimer disease , it is unknown whether they represent an independent source of impairment or interact with known markers of disease .


To examine the degree to which WMHs predict aggressive cognitive decline among individuals with mild cognitive impairment , either independently or by modifying the effects of entorhinal cortex volume ( ECV ) , a marker of Alzheimer disease-related neurodegeneration .


The Alzheimer 's Disease Neuroimaging Initiative is a longitudinal study with 6-month follow-up visits .


Three hundred thirty-two participants ( mean [ SD ] age , 74.6 [ 7.4 ] years ; 118 women ) of a total of 374 participants diagnosed as having mild cognitive impairment were included .


Participants were excluded if they did not have longitudinal data , apolipoprotein E genotype data , or had evidence of supratentorial infarct .


A decline in Mini-Mental State Examination score of 3 points over 6 months or 6 points over 1 year between consecutive visits was defined as aggressive decline .


White matter hyperintensity volume and ECV were entered as predictors in Cox proportional hazards models and Wilcoxon-Breslow tests to examine their impact on this outcome , adjusting for sex , age , education , and apolipoprotein E status .


Greater WMH volume at baseline , apolipoprotein E 4 status , and smaller ECV at baseline were associated with an increased risk for aggressive decline ( hazard ratio [ HR ] , 1.23 ; 95 % CI , 1.05-1 .43 ; P = .01 for WMH volume ; HR , 1.49 ; 95 % CI , 1.09-2 .05 ; P = .04 for apolipoprotein E 4 status ; HR , 0.66 ; 95 % CI , 0.55-0 .79 ; P < .001 for ECV ) .


White matter hyperintensity volume modified the effect of ECV on aggressive decline risk : individuals with high ECV and low WMH were at particularly low likelihood of decline ( 2 = 15 , P = .001 ) .


Participants with Mini-Mental State Examination scores that declined by 3 or more points over 6 months or 6 or more points over 12 months were more likely to have converted to Alzheimer disease by the end of the follow-up period ( 2 = 82 , P < .001 ) .


White matter hyperintensity burden and ECV predict rapid cognitive decline among individuals with mild cognitive impairment both additively and multiplicatively .


There is a need for an adjuvant agent of caudal block that prolongs its duration and improves the analgesic efficacy to fasten functional recovery .


Magnesium is an N-methyl-D-aspartate receptor antagonist that functions as an analgesic .


This study was aimed to evaluate whether magnesium as an adjuvant for caudal block in children can improve postoperative analgesia and functional recovery .


Eighty children , 2-6 years of age , undergoing inguinal herniorrhaphy , were included in this prospective , randomized , double-blinded study .


For caudal block , Group R received ropivacaine 1.5 mgml ( -1 ) , 1 mlkg ( -1 ) and Group RM received the same dose of ropivacaine mixed with 50 mg of magnesium .


The Parents ' Postoperative Pain Measure ( PPPM ) score , analgesic consumption , functional recovery , and adverse effects were evaluated at 6 , 24 , 48 , and 72 h after surgery , as well as daily thereafter until the child showed full functional recovery .


The PPPM score after hospital discharge was significantly lower for Group RM than for Group R at all times ( P < 0.05 ) .


Children in Group RM required less fentanyl for rescue analgesia in the recovery area ( 16.2 % vs 39.5 % , P = 0.034 ) and less oral analgesics after discharge ( 20.5 % vs 52.6 % , P = 0.007 ) .


The time to return of normal functional activity was shorter in Group RM ( P < 0.05 ) .


The incidence of adverse effects did not differ between groups .


As an adjuvant for caudal analgesia , 50 mg magnesium provided superior quality of analgesia and faster return of normal functional activity than local anesthetic alone in children .


Cytology is a widely used method of triaging women who test positive for human papillomavirus ( HPV ) .


However , self-sampled specimens , which can substantially increase participation in screening programmes , are not suitable for accurate cytological assessment .


We investigated whether direct DNA methylation-based molecular triage on self-sampled cervicovaginal specimens was non-inferior to cytology triage on additional physician-collected cervical samples in the detection of cervical intraepithelial neoplasia grade 2 ( CIN2 ) or worse in women who did not attend cervical screening programmes .


In this randomised controlled non-inferiority trial , we invited women ( aged 33-63 years ) registered as non-attendees of cervical screening in the Netherlands in 2007 to submit a self-collected cervicovaginal sample for HPV testing .


Using a computer-generated sequence , we randomly allocated women who tested positive for high-risk hrHPV on a self-sample to either triage by cytology on an additional physician-taken smear or direct triage on the self-sample by methylation analysis of MAL and miR-124-2 genes ( 1:1 ; stratified by age and region , with block sizes by age group ) .


Triage-positive women in either group were referred for colposcopy .


The primary endpoint was detection of CIN2 or worse , analysed by intention to treat .


The non-inferiority margin was 080 .


This study is registered in the Primary Trial Register of the Netherlands , number NTR6026 .


We invited 46,001 women to participate , 12,819 of whom returned self-sampled material ; 1038 samples tested positive for high-risk HPV .


Between Nov 1 , 2010 , and Dec 31 , 2011 , after exclusion of women who were ineligible , we enrolled and randomly allocated 515 women to methylation triage and 509 to cytology triage .


The detection of CIN2 or worse with methylation triage was non-inferior to that with cytology triage ( 90 [ 17 % ] of 515 women vs 75 [ 15 % ] of 509 women ; relative risk 119 , 95 % CI 090-157 ) .


Referral for colposcopy was more common in the molecular group ( 284 [ 55 % ] women ) than in the cytology group ( 149 [ 29 % ] women ; p < 00001 ) .


Mean time to CIN2 or worse diagnosis was shorter in the molecular triage group ( 96 days , range 44-101 ) than in the cytology triage group ( 158 days , 71-222 ; p = 000084 ) .


DNA methylation analysis of MAL and miR-124-2 genes on HPV-test-positive self-samples is non-inferior to cytology triage in the detection of CIN2 or worse , opening the way to full molecular screening .


Midden-West and Oost Screening Organisations and Stichting Achmea Gezondheidszorg .


To evaluate the effect of artificial demineralization upon color change of dentin in contact with dental amalgam .


Sound human molars ( n = 34 ) were embedded in resin and coronal enamel was removed .


Dentin was exposed to artificial caries gel ( pH 5.5 ) at 37 degrees C for 12 weeks ( n = 24 ) .


Non-demineralized teeth served as controls ( n = the 10 ) .


A dispersive high-Cu amalgam or conventional low-Cu amalgam was condensed onto dentin surfaces of all groups .


After 10 weeks storage in saline , amalgam was removed and teeth were cut into three slices .


Surfaces were inspected under optical microscopy and photographed .


Penetration of black pigments was observed in dentin underneath both high-Cu and low-Cu amalgams in demineralized specimens .


Black deposits were unevenly distributed and observed predominantly in dentin near to pulp horns .


Discoloration was not limited to outer demineralized dentin but extended beyond this zone .


Evenly distributed bluish-green discoloration was observed underneath all high-Cu amalgam specimens independent of demineralization .


Evaluation of analgesia and antinociception during anaesthesia is still a challenging issue and routinely based on indirect and non-specific signs such as movement , tachycardia , or lacrimation .


Recently , the surgical pleth index ( SPI ) derived by finger plethysmography was introduced to detect nociceptive stimulation during anaesthesia .


While SPI guidance reduced the number of unwanted events during total i.v. anaesthesia ( TIVA ) , the impact of SPI during volatile-based anaesthesia with intermittent opioid administration has not yet been elucidated .


Ninety-four patients were randomized into either SPI-guided analgesia or standard practice ( Control ) .


In both groups , anaesthesia was maintained with sevoflurane to keep bispectral index values between 40 and 60 .


In the SPI group , patients received a sufentanil bolus ( 10 g ) whenever SPI value increased above 50 , whereas in the control group , sufentanil was administered according to standard clinical practice .


The number of unwanted somatic events , haemodynamics , sufentanil consumption , and recovery times were recorded .


The incidence of intraoperative unwanted somatic events was comparable between the groups ( P = 0.89 ) .


No significant differences with respect to hypotensive or hypertensive events were found .


The mean ( 95 % confidence interval ) sufentanil consumption was non-significantly ( P = 0.07 ) reduced in the SPI group , 0.64 ( 0.57-0 .71 ) vs 0.78 ( 0.64-0 .91 ) g min ( -1 ) .


Recovery times were comparable between the groups .


Sufentanil administration guided by SPI during sevoflurane anaesthesia is clinically feasible .


In contrast to TIVA , it did not improve anaesthesia conduct with respect to unwanted somatic events , haemodynamic stability , sufentanil consumption , emergence time , or post-anaesthesia care unit care .


Therefore , we conclude that anaesthesia regimen has an impact on beneficial effects by SPI guidance .


Clinical trial registration NCT01525537 .


( Registered at Clinicaltrials.gov . )


Equol is produced by the intestinal bacteria from isoflavone daidzein .


Studies have reported the health benefits of soy can only present or more pronounced in equol producers .


This 6-month randomized controlled trial examined the effect of whole soy ( soy flour ) and purified daidzein on cardiovascular biomarkers and carotid intima-media thickness ( CIMT ) in prehypertensive postmenopausal women who were equol producers .


Two hundred seventy eligible women were randomized to either one of the three treatments : 40 g soy flour ( whole soy group ) , 40 g low-fat milk powder + 63mg daidzein ( daidzein group ) , or 40 g low-fat milk powder ( placebo group ) daily each for 6 months .


Fasting venous samples were obtained at baseline and end of trial for testing glucose , lipids , high sensitivity C-reactive protein ( hs-CRP ) , and free fatty acid .


Changes in common CIMT were also assessed .


Serum LDL-C decreased by 7.95 % ( 95 % CI : -15.09 -0.81 % ) and 6.32 % ( 95 % CI : -13.450.08 % ) , and serum hs-CRP decreased by 0.164 ( 95 % CI : -0.309 -0.019 ) and 0.054 ( 95 % CI : -0.1990.012 ) in the whole soy group compared with daidzein and milk placebo groups , respectively .


No significant change in CIMT was found .


Whole soy , but not purified daidzein , had a beneficial effect on reduction of LDL-C and hs-CRP among prehypertensive equol-producing postmenopausal women .


To investigate the effectiveness of an intensive nursing care electronic followup system for cardiovascular risk management after percutaneous coronary intervention ( PCI ) .


In total , 840 subjects who underwent PCI in a single hospital in Beijing between January 2010 and January 2012 were enrolled .


All subjects were randomized into the control and intensive nursing care groups ( n = 420 each group ) .


Both groups received standard secondary prevention according to guidelines .


The control group received regular followup while the intensive nursing care group was closely monitored and followed by specific nursing staff with the electronic followup system .


In total , 807 subjects were followed up for 1 year .


Compared with subjects in the control group , those in the intensive group had decreased levels of total cholesterol ( 3.99 1.08 vs 3.76 0.98 ; P < .05 ) , systolic blood pressure ( 142.41 11.53 vs 135.71 14.57 mm Hg ; P < .05 ) , low-density lipoprotein cholesterol ( LDL-C ) ( 2.72 1.01 vs 2.42 0.81 ; P < .05 ) , and body mass index ( 25.13 5.12 vs 24.23 6.22 ; P < .05 ) ; a higher percentage with target LDL-C < 2.6 mmol/L ( 66.99 % vs 47.88 % ; P < .05 ) ; increased use of medication including aspirin ( 96.51 % vs 99.26 % ; P < .05 ) , clopidogrel ( 87.53 % vs 98.77 % ; P < .05 ) , statins ( 52.62 % vs 93.10 % ; P < .05 ) , - blockers ( 48.63 % vs 61.33 % ; P < .05 ) , and angiotensin-converting enzyme inhibitors ( 32.92 % vs 61.82 % ; P < .05 ) ; and better dietary control and physical exercise ( 55.66 % vs 26.18 % , P < .05 ; 62.56 % vs 38.65 % , P < .05 ) .


Intensive nursing care by the electronic followup system may lead to an improvement in quality of secondary prevention after PCI , including risk factor control , the use of medication , and self-management abilities .


This study evaluates the efficacy of integrating PTSD treatment into Dialectical Behavior Therapy ( DBT ) for women with borderline personality disorder , PTSD , and intentional self-injury .


Participants were randomized to DBT ( n = 9 ) or DBT with the DBT Prolonged Exposure ( DBT PE ) protocol ( n = 17 ) and assessed at 4-month intervals during the treatment year and 3-months post-treatment .


Treatment expectancies , satisfaction , and completion did not differ by condition .


In DBT+DBT PE , the DBT PE protocol was feasible to implement for a majority of treatment completers .


Compared to DBT , DBT+DBT PE led to larger and more stable improvements in PTSD and doubled the remission rate among treatment completers ( 80 % vs. 40 % ) .


Patients who completed the DBT PE protocol were 2.4 times less likely to attempt suicide and 1.5 times less likely to self-injure than those in DBT .


Among treatment completers , moderate to large effect sizes favored DBT+DBT PE for dissociation , trauma-related guilt cognitions , shame , anxiety , depression , and global functioning .


DBT with the DBT PE protocol is feasible , acceptable , and safe to administer , and may lead to larger improvements in PTSD , intentional self-injury , and other outcomes than DBT alone .


The findings require replication in a larger sample .


Recent studies of inhaled tobramycin in subjects with cystic fibrosis ( CF ) find less clinical improvement than previously observed .


Nonhuman data suggest that in some strains of Pseudomonas aeruginosa , azithromycin can antagonize tobramycin .


We tested the hypothesis that concomitant azithromycin use correlates with less improvement in key outcome measures in subjects receiving inhaled tobramycin while not affecting those receiving a comparative , nonaminoglycoside inhaled antibiotic .


We studied a cohort of 263 subjects with CF enrolled in a recent clinical trial comparing inhaled tobramycin with aztreonam lysine .


We performed a secondary analysis to examine key clinical and microbiologic outcomes based on concomitant , chronic azithromycin use at enrollment .


The cohort randomized to inhaled tobramycin and reporting azithromycin use showed a significant decrease in the percent predicted FEV1 after one and three courses of inhaled tobramycin when compared with those not reporting azithromycin use ( 28 d : -0.51 vs. 3.43 % , P < 0.01 ; 140 d : -1.87 vs. 6.07 % , P < 0.01 ) .


Combined azithromycin and inhaled tobramycin use was also associated with earlier need for additional antibiotics , lesser improvement in disease-related quality of life , and a trend toward less reduction in sputum P. aeruginosa density .


Subjects randomized to inhaled aztreonam lysine had significantly greater improvement in these outcome measures , which were unaffected by concomitant azithromycin use .


Outcomes in those not using azithromycin who received inhaled tobramycin were not significantly different from subjects receiving aztreonam lysine .


Azithromycin also antagonized tobramycin but not aztreonam lysine in 40 % of P. aeruginosa clinical isolates tested in vitro .


Oral azithromycin may antagonize the therapeutic benefits of inhaled tobramycin in subjects with CF with P. aeruginosa airway infection .


To evaluate the efficacy and safety of the 3-adrenoceptor agonist mirabegron , in a Japanese population with overactive bladder ( OAB ) .


This randomised , double-blind , placebo-controlled phase III study enrolled adult patients experiencing OAB symptoms for 24 weeks .


Patients with 8 micturitions/24h and 1 urgency episode/24h or 1 urgency incontinence episode/24h were randomised to once-daily placebo , mirabegron 50mg or tolterodine 4mg ( as an active comparator , without testing for non-inferiority of efficacy and safety ) for 12 weeks .


The primary endpoint was the change in the mean number of micturitions/24h from baseline to final assessment .


Secondary endpoints included micturition variables related to urgency and/or incontinence and quality-of-life domain scores on the King 's Health Questionnaire .


Safety assessments included adverse events ( AEs ) , post-void residual urine volume , laboratory variables , vital signs and 12-lead electrocardiogram .


A total of 1139 patients were randomised to receive placebo ( n = 381 ) , mirabegron 50mg ( n = 380 ) or tolterodine 4mg ( n = 378 ) .


Demographic and baseline characteristics were similar among the treatment groups .


At final assessment , mirabegron was significantly superior to placebo in terms of mean [ sd ] change from baseline in number of micturitions/24h ( -1.67 [ 2.212 ] vs -0.86 [ 2.354 ] ; P < 0.001 ) and mean [ sd ] change from baseline in number of urgency episodes/24h ( -1.85 [ 2.555 ] vs -1.37 [ 3.191 ] ; P = 0.025 ) , incontinence episodes/24h ( -1.12 [ 1.475 ] vs -0.66 [ 1.861 ] ; P = 0.003 ) , urgency incontinence episodes/24h ( -1.01 [ 1.338 ] vs -0.60 [ 1.745 ] ; P = 0.008 ) , and volume voided/micturition ( 24.300 [ 35.4767 ] vs 9.715 [ 29.0864 ] mL ; P < 0.001 ) .


The incidence of AEs in the mirabegron group was similar to that in the placebo group .


Most AEs were mild and none were severe .


Mirabegron 50mg once daily is an effective treatment for OAB symptoms , with a low occurrence of side effects in a Japanese population .


Acute hemorheological responses to different types of aerobic exercises have never been compared in a single study in healthy people .


We aimed to compare acute effects of high intensity intermittent exercise ( HIIE ) and moderate intensity continuous exercise ( MICE ) on hemorheological parameters , in healthy young subjects .


A total of 34 sedentary young adults ( 12 males , 22 females ) with a mean age of 20.0 2.1 years were randomly assigned to HIIE , MICE or non-exercise groups .


MICE exercised at the power corresponding to 50 % of heart rate reserve ( HRR ) continuously for 25 min .


HIIE exercised at the power corresponding to 100 % of HRR for 30 s followed by 30 s rest for 25 min .


The non-exercise group rested .


Blood samples were collected before and after exercise and studied for blood count , whole blood viscosity ( WBV ) , plasma viscosity ( PV ) and red blood cell ( RBC ) elongation at nine different shear stresses .


WBV , PV , RBC elongation of MICE and HIIE groups were not found to be statistically different from each other or from the non-exercise group .


Compared to the non-exercise group , there was a significant increase in white blood cell ( WBC ) and RBC counts in the MICE group .


Different types of aerobic exercises , namely MICE , HIIE are not different from each other in terms of hemorheological parameters immediately after exercise .


To determine the effectiveness of a peer-led self-management programme for people with schizophrenia in reducing psychotic symptom severity , hospital readmission and psychiatric consultation and in enhancing cognition , empowerment , functioning level , medication adherence , perceived recovery , quality of life and social support .


Several self-management programmes have been developed to empower patients with severe mental illness in achieving recovery .


Research suggests that peer-led self-management programmes have positive effects on patient recovery .


However , the existing evidence is inconclusive , due to a lack of credible evidence and long-term follow-up evaluations .


A stratified randomized controlled trial will be conducted at six community mental health rehabilitation centres


A sample of 242 adults with schizophrenia will be recruited .


A peer-led self-management programme , comprising six 2-hour sessions , will be implemented in the intervention group and a standard rehabilitation programme in the control group .


Outcomes will be measured at baseline , postintervention and at the 6 - and 12-month follow-ups .


The measures will include cognition , empowerment , functioning level , medication adherence , perceived recovery , quality of life , social support , symptom severity , hospital readmission and psychiatric consultation .


A mixed effects model will be used to analyse the results .


Semi-structured interviews will be conducted to explore the peer-trainers ' and participants ' perspectives on the programme .


Research Ethics Committee approval was obtained in December 2011 and funding was obtained in January 2012 .


This study will provide evidence on the effectiveness of a peer-led self-management programme for patient recovery .


It will identify a clinically useful and potentially effective intervention that incorporates empowerment concept .


The optimum dose of key antiretroviral drugs is often overlooked during product development .


The ENCORE1 study compared the efficacy and safety of reduced dose efavirenz with standard dose efavirenz in combination with tenofovir and emtricitabine as first-line treatment for HIV infection .


An effective and safe reduced dose could yield meaningful cost savings .


ENCORE1 is a continuing non-inferiority trial in HIV-1-infected antiretroviral-naive adults in 38 clinical sites in 13 countries .


Participants ( plasma HIV-RNA > 1000 log10 copies per mL , CD4 T-cell count 50-500 cells per L ) were randomly assigned by a computer-generated sequence with a blocking factor of four ( stratified by clinical site and by screening viral load ) to receive tenofovir plus emtricitabine with either a reduced daily dose ( 400 mg ) or a standard dose ( 600 mg ) of efavirenz .


Participants , physicians , and all other trial staff were masked to treatment group .


The primary endpoint was the difference in proportions of participants with plasma HIV-RNA of less than 200 copies per mL at 48 weeks .


Treatment groups were regarded as non-inferior if the lower limit of the 95 % CI for the difference in viral load was less than -10 % by modified intention-to-treat analysis .


Adverse events were summarised by treatment .


This trial is registered with ClinicalTrials.gov , number NCT01011413 .


The modified intention-to-treat analysis consisted of 630 patients ( efavirenz 400 = 321 ; efavirenz 600 = 309 ) .


32 % were women ; 37 % were African , 33 % were Asian , and 30 % were white .


The mean baseline CD4 cell count was 273 cells per L ( SD 99 ) and median plasma HIV-RNA was 475 log10 copies per mL ( IQR 088 ) .


The proportion of participants with a viral load below 200 copies per mL at week 48 was 941 % for efavirenz 400 mg and 922 % for 600 mg ( difference 185 % , 95 % CI -21 to 579 ) .


CD4 T-cell counts at week 48 were significantly higher for the 400 mg group than for the 600 mg group ( mean difference 25 cells per L , 95 % CI 6-44 ; p = 001 ) .


We recorded no difference in grade or number of patients reporting adverse events ( efavirenz 400 = 891 % , efavirenz 600 = 884 % ; difference 075 % , 95 % CI -419 to 569 ; p = 077 ) .


Study drug-related adverse events were significantly more frequent in the 600 mg group than in the 400 mg group ( 146 % [ 47 ] vs 118 [ 37 ] ) , difference -105 % , 95 % CI -182 to -28 ; p = 001 ) and significantly fewer patients with these events stopped treatment ( 400 mg = 6 [ 2 % ] , 600 mg = 18 [ 6 % ] , difference -396 % , 95 % CI -696 to -095 ; p = 001 ) .


Our findings suggest that a reduced dose of 400 mg efavirenz is non-inferior to the standard dose of 600 mg , when combined with tenofovir and emtricitabine during 48 weeks in ART-naive adults with HIV-1 infection .


Adverse events related to the study drug were more frequent with 600 mg efavirenz than with 400 mg .


Lower dose efavirenz should be recommended as part of routine care .


Bill & Melinda Gates Foundation , University of New South Wales .