Mixed effects models were used to examine change in goal engagement between the weeks when POWeR Tracker was and was not available and whether the extent of change in goal engagement varied between individual participants .


Usage of POWeR and POWeR Tracker was automatically recorded for each participant .


Telephone interviews were conducted and analyzed using inductive thematic analysis to further explore participants ' experiences using POWeR and POWeR Tracker .


Access to POWeR Tracker was associated with a significant increase in participants ' awareness of their eating ( @ = @ , P = @ ) and physical activity goals ( @ = @ , P = @ ) .


The level of increase varied between individual participants .


Usage data showed that participants used the POWeR website for similar amounts of time during the weeks when POWeR Tracker was ( mean @ minutes , SD @ minutes ) and was not available ( mean @ minutes , SD @ minutes ) .


POWeR Tracker was mostly accessed in short bursts ( mean @ minutes , SD @ minutes ) during convenient moments or moments when participants deemed the intervention content most relevant .


The qualitative data indicated that nearly all participants agreed that it was more convenient to access information on-the-go via their mobiles compared to a computer .


However , participants varied in their views and usage of the Web - versus app-based components and the informational versus tracking tools provided by POWeR Tracker .


This study provides evidence that smartphones have the potential to improve individuals ' engagement with their health-related goals when used as a supplement to an existing online intervention .


The perceived convenience of mobile access to information does not appear to deter use of Web-based interventions or strengthen the impact of app access on goal engagement .


A mixed-methods design enabled exploration of individual variation in daily usage of the app-based tools .


Though theoretically superior to standard @D visualization , @D video systems have not yet achieved a breakthrough in laparoscopy .


The latest @D monitors , including autostereoscopic displays and high-definition ( HD ) resolution , are designed to overcome the existing limitations .


We performed a randomized study on @ individuals with different experience levels in laparoscopy .


Three different @D displays ( glasses-based @D monitor , autostereoscopic display , and a mirror-based theoretically ideal @D display ) were compared to a @D HD display by assessing multiple performance and mental workload parameters and rating the subjects during a laparoscopic suturing task .


Electromagnetic tracking provided information on the instruments ' pathlength , movement velocity , and economy .


The usability , the perception of visual discomfort , and the quality of image transmission of each monitor were subjectively rated .


Almost all performance parameters were superior with the conventional glasses-based @D display compared to the @D display and the autostereoscopic display , but were often significantly exceeded by the mirror-based @D display .


Subjects performed a task faster and with greater precision when visualization was achieved with the @D and the mirror-based display .


Instrument pathlength was shortened by improved depth perception .


Workload parameters ( NASA TLX ) did not show significant differences .


Test persons complained of impaired vision while using the autostereoscopic monitor .


The @D and @D displays were rated user-friendly and applicable in daily work .


Experienced and inexperienced laparoscopists profited equally from using a @D display , with an improvement in task performance about @ % .


Novel @D displays improve laparoscopic interventions as a result of faster performance and higher precision without causing a higher mental workload .


Therefore , they have the potential to significantly impact the further development of minimally invasive surgery .


However , as shown by the custom-built @D mirror display , this effect can be improved , thus stimulating further research .


Magnesium sulfate is neuroprotective in preclinical models of stroke and has shown signals of potential efficacy with an acceptable safety profile when delivered early after stroke onset in humans .


Delayed initiation of neuroprotective agents has hindered earlier phase @ trials of neuroprotective agents .


We randomly assigned patients with suspected stroke to receive either intravenous magnesium sulfate or placebo , beginning within @ hours after symptom onset .


A loading dose was initiated by paramedics before the patient arrived at the hospital , and a @-hour maintenance infusion was started on the patient 's arrival at the hospital .


The primary outcome was the degree of disability at @ days , as measured by scores on the modified Rankin scale ( range , @ to @ , with higher scores indicating greater disability ) .


Among the @ enrolled patients ( @ in the magnesium group and @ in the placebo group ) , the mean ( SD ) age was @ years , @ % were women , and the mean pretreatment score on the Los Angeles Motor Scale of stroke severity ( range , @ to @ , with higher scores indicating greater motor deficits ) was @ .


The final diagnosis of the qualifying event was cerebral ischemia in @ % of patients , intracranial hemorrhage in @ % , and a stroke-mimicking condition in @ % .


The median interval between the time the patient was last known to be free of stroke symptoms and the start of the study-drug infusion was @ minutes ( interquartile range , @ to @ ) , and @ % of patients received the study-drug infusion within the first hour after symptom onset .


There was no significant shift in the distribution of @-day disability outcomes on the global modified Rankin scale between patients in the magnesium group and those in the placebo group ( P = @ by the Cochran-Mantel-Haenszel test ) ; mean scores at @ days did not differ between the magnesium group and the placebo group ( @ in each group , P = @ ) .


No significant between-group differences were noted with respect to mortality ( @ % in the magnesium group and @ % in the placebo group , P = @ ) or all serious adverse events .


Prehospital initiation of magnesium sulfate therapy was safe and allowed the start of therapy within @ hours after the onset of stroke symptoms , but it did not improve disability outcomes at @ days .


( Funded by the National Institute of Neurological Disorders and Stroke ; FAST-MAG ClinicalTrials.gov number , NCT@ . )


To compare left ventricular function after a long-term His or para-His pacing ( HP ) and right ventricular septal pacing ( RVSP ) in patients with atrioventricular block ( AVB ) .


We included consecutive patients with AVB , a narrow QRS < @ ms , and a preserved left ventricular ejection fraction ( LVEF ) > @ , in a prospective , randomized , double-blinded , crossover design .


All patients were treated with @ months HP and @ months RVSP .


A total of @ patients -LSB- mean age , @ @ years ; @ ( @ % ) men -RSB- were included .


The primary endpoint was LVEF , which was significantly lower after a @ months RVSP ( @ @ ) than after @ months of HP ( @ @ ) , P = @ .


We measured the difference in time-to-peak systolic velocity between opposite basal segments in the apical views by using tissue Doppler imaging .


In the four-chamber view , the difference was @ ( @ ) ms after RVSP and @ ( @ ) ms after HP , P = @ ; in the two-chamber view , the difference was @ ( @ ) ms after RVSP and @ ( @ ) ms after HP , P = @ , and in the apical long-axis view , the difference was @ ( @ ) after RVSP and @ ( @ ) after HP , P = @ .


There was no difference in New York Heart Association class , @-min hall walk test , quality-of-life assessments , or device-related complications .


The mean threshold was significantly higher in HP leads than in RVSP leads .


His or para-His pacing preserves LVEF and mechanical synchrony as compared with RVSP after @ months pacing in patients with AVB , narrow QRS , and LVEF > @ .


People with psychosis often experience weight gain , which places them at risk of cardiovascular disease , diabetes , and early death .


To determine the uptake , adherence , and clinical effectiveness of a healthy living intervention designed to reduce weight gain .


An exploratory randomized controlled trial , comparing the intervention with treatment as usual ( TAU ) in @ early intervention services for psychosis in England .


DSM-IV classification was the diagnostic criteria used to assign the psychiatric diagnoses .


The primary outcome was change in body mass index ( BMI ) from baseline to @-month follow-up .


The study was conducted between February @ and October @ .


@ service users , with a BMI of @ ( @ in South Asians ) , were randomized to intervention ( n = @ ) or TAU ( n = @ ) after stratification by recent commencement of antipsychotic medication .


Ninety-three service users ( @ % ) were followed up at @ months .


Between-group difference in change in BMI was not significant ( effect size = @ ) .


The effect of the intervention was larger ( effect size = @ , not significant ) in @ intervention ( @ % ) and @ TAU ( @ % ) participants who were taking olanzapine or clozapine at randomization .


The healthy living intervention did not show a significant difference in BMI reduction compared to the TAU group .


Prader-Willi syndrome is a neurogenetic disorder , with characteristics such as obesity , short stature , muscular weakness , intellectual deficiencies and deviant social behaviour .


This study evaluated whether growth hormone treatment of children with Prader-Willi syndrome resulted in possible and lasting effects on their cognition and behaviour .


We randomised six girls and @ boys to either a treatment group or a control group .


The treatment group received growth hormone ( Genotropin ( ) @ mg/kg/day ) for @ years , while the control group did not receive treatment in the first year and then received a double dose in the second year .


Treatment was then stopped in both groups for @ months .


Both groups showed the same intellectual disabilities at the start of the study , and no difference was found after the first and second years .


The parents reported that the children showed increased vitality during treatment .


When treatment was stopped , the children showed a marked exacerbation of behavioural problems , a significant increase in body fat and a decrease in insulin-like growth factor @ levels .


We believe this is the first study to show that abrupt-ceasing growth hormone treatment led to a successive deterioration in behavioural problems in children with Prader-Willi syndrome .


Aside from the multikinase inhibitor sorafenib , there are no effective systemic therapies for the treatment of advanced hepatocellular carcinoma .


To assess the efficacy of everolimus in patients with advanced hepatocellular carcinoma for whom sorafenib treatment failed .


EVOLVE-@ was a randomized , double-blind , phase @ study conducted among @ adults with Barcelona Clinic Liver Cancer stage B or C hepatocellular carcinoma and Child-Pugh A liver function whose disease progressed during or after sorafenib or who were intolerant of sorafenib .


Patients were enrolled from @ countries between May @ and March @ .


Randomization was stratified by region ( Asia vs rest of world ) and macrovascular invasion ( present vs absent ) .


Everolimus , @ mg/d , or matching placebo , both given in combination with best supportive care and continued until disease progression or intolerable toxicity .


Per the @:@ randomization scheme , @ patients were randomized to the everolimus group and @ patients to the placebo group .


The primary end point was overall survival .


Secondary end points included time to progression and the disease control rate ( the percentage of patients with a best overall response of complete or partial response or stable disease ) .


No significant difference in overall survival was seen between treatment groups , with @ deaths ( @ % ) in the everolimus group and @ deaths ( @ % ) in the placebo group ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @-@ @ ; P = @ ; median overall survival , @ months with everolimus , @ months with placebo ) .


Median time to progression with everolimus and placebo was @ months and @ months , respectively ( HR , @ ; @ % CI , @-@ @ ) , and disease control rate was @ % and @ % , respectively ( P = @ ) .


The most common grade @/@ adverse events for everolimus vs placebo were anemia ( @ % vs @ % , respectively ) , asthenia ( @ % vs @ % , respectively ) , and decreased appetite ( @ % vs @ % , respectively ) .


No patients experienced hepatitis C viral flare .


Based on central laboratory results , hepatitis B viral reactivation was experienced by @ patients ( @ everolimus , @ placebo ) ; all cases were asymptomatic , but @ everolimus recipients discontinued therapy .


Everolimus did not improve overall survival in patients with advanced hepatocellular carcinoma whose disease progressed during or after receiving sorafenib or who were intolerant of sorafenib .


Right - and left-sided colon cancers ( RC , LC ) differ with respect to biology , pathology and epidemiology .


Previous data suggest a mortality difference between RC and LC .


We examined if primary tumour side also predicts for outcome in chemotherapy refractory , metastatic colon cancer ( MCC ) .


We also compared RC versus LC as a predictor of efficacy of epidermal growth factor receptor ( EGFR ) inhibition with cetuximab .


Reanalyzing NCIC CO. @ trial ( cetuximab versus best supportive care -LSB- BSC -RSB- ) , we coded the primary tumour side as RC ( caecum to transverse colon ) or LC ( splenic flexure to rectosigmoid ) .


The association between tumour side and baseline characteristics was assessed .


Cox regression models determined factors affecting overall survival ( OS ) and progression free survival ( PFS ) .


Patients with RC ( @/@ ) had more poorly differentiated , mutant KRAS , mutated PIK@CA and wild-type BRAF tumours , fewer liver and lung metastases , and shorter interval between diagnosis and study entry .


Among BSC patients , tumour side was not prognostic for PFS ( hazard ratios ( HR ) @ -LSB- @-@ @ -RSB- , p = @ ) or OS ( HR @ -LSB- @-@ @ -RSB- , p = @ ) .


Among wild-type KRAS patients , those with LC had significantly improved PFS when treated with cetuximab compared to BSC ( median @ versus @ months , HR @ -LSB- @-@ @ -RSB- , p < @ ) , whereas those with RC did not ( median @ versus @ months , HR @ -LSB- @-@ @ -RSB- , p = @ ) , -LSB- interaction p = @ -RSB- .


In refractory MCC , tumour location within the colon is not prognostic , but is strongly predictive of PFS benefit from cetuximab therapy .


Additional research is needed to understand the molecular differences between RC and LC and their interaction with EGFR inhibition .


There is evidence of an association between pulmonary function and various nutrients , although no association has been observed in our setting between the Mediterranean Diet ( MD ) eating pattern and improved lung function .


The objective of this study is to evaluate the effect of an intervention designed to increase MD adherence on lung function in smokers with no previous respiratory disease .


Randomized , controlled , parallel clinical trial .


primary health care centers in Catalonia ( Spain ) .


Current smokers ( cumulative > @ pack-years ) aged @-@ years , with Internet access , who provide signed informed consent to participate .


A nutritionist will conduct a @-year multicomponent intervention to increase MD adherence , based on : @ ) a personalized dietary-nutritional education intervention , @ ) a Web @ approach , the DIET Blog of nutritional information , and @ ) group sessions to increase motivation to increase MD adherence and motivation to make changes in eating habits .


Annually , an office visit and one group session will reinforce the nutritional intervention .


The control group will follow their usual diet , with general nutritional counselling .


In both groups , a @-item questionnaire will evaluate individual MD dietary patterns and forced spirometry will assess lung function .


Intention to treat .


The unit of analysis will be the individual smoker .


Primary outcome is lung function indicated by spirometry , FVC , FEV@ and FEV@/FVC % .


Lung function parameters in both groups will be compared by adherence to the MD pattern .


The DIET study could contribute data on a protective action of the MD pattern on lung function in smokers .


If so , this population may benefit from a nutritional intervention , along with the fundamental recommendation to stop smoking .


The effects of opioid medication on cognitive functioning in patients with cancer and non-cancer pain remain unclear .


In this mechanistic randomized , double-blind , placebo-controlled , cross-over study of patients ( n = @ ) receiving sustained-release and immediate-release opioid medication as part of their palliative care , we examine memory effects of an additional dose of participants ' immediate-release medication ( oxycodone or morphine ) or placebo .


Immediate prose recall and recall of related and unrelated word pairs was assessed pre-and post-drug ( placebo or immediate-release opioid ) .


Memory for these stimuli was also tested after a delay on each testing occasion .


Finally , performance on an ` interference ' word pair task was assessed on the two testing occasions since proactive interference has been posited as a mechanism for acute opioid-induced memory impairment .


Unlike previous work , we found no evidence of memory impairment for material presented before or after individually tailored , ` breakthrough ' doses of immediate-release opioid .


Furthermore , immediate-release opioid did not result in increased memory interference .


On the other hand , we found enhanced performance on the interference word pair task after immediate-release opioid , possibly indicating lower levels of interference .


These results suggest that carefully titrated immediate-release doses of opioid drugs may not cause extensive memory impairment as previously reported , and in fact , may improve memory in certain circumstances .


Importantly , our findings contrast strikingly with those of a study using the same robust design that showed significant memory impairment .


We propose that factors , such as depressive symptoms , education level and sustained-release opioid levels may influence whether impairment is observed following immediate-release opioid treatment .


Emergency abdominal surgery carries a considerable risk of death and postoperative complications .


Early detection and timely management of complications may reduce mortality .


The aim was to evaluate the effect and feasibility of intermediate care compared with standard ward care in patients who had emergency abdominal surgery .


This was a randomized clinical trial carried out in seven Danish hospitals .


Eligible for inclusion were patients with an Acute Physiology And Chronic Health Evaluation ( APACHE ) II score of at least @ who were ready to be transferred to the surgical ward within @h of emergency abdominal surgery .


Participants were randomized to either intermediate care or standard surgical ward care after surgery .


The primary outcome was @-day mortality .


In total , @ patients were included in the modified intention-to-treat analysis .


The trial was terminated after the interim analysis owing to slow recruitment and a lower than expected mortality rate .


Eleven ( @ per cent ) of @ patients assigned to intermediate care and @ ( @ per cent ) of @ patients assigned to ward care died within @ days of surgery ( odds ratio @ , @ per cent c.i. @ to @ ; P = @ ) .


Thirty ( @ per cent ) of @ patients assigned to intermediate care and @ ( @ per cent ) of @ assigned to ward care died within the total observation period ( hazard ratio @ , @ per cent c.i. @ to @ ; P = @ ) .


Postoperative intermediate care had no statistically significant effect on @-day mortality after emergency abdominal surgery , nor any effect on secondary outcomes .


The trial was stopped prematurely owing to slow recruitment and a much lower than expected mortality rate among the enrolled patients .


To examine the effects of a group music therapy on psychiatric symptoms and depression for patient with schizophrenia in a psychiatric nursing home .


Eighty patients with schizophrenia were randomly assigned to a music intervention group ( MIG ) or usual care group ( UCG ) .


Both groups received similar medical and routine care .


The MIG received a @-min group music therapy twice a week , a total of ten sessions .


The UAG only received the usual care with no music therapy .


Psychiatric symptoms and depression assessments were conducted using the positive and negative syndrome scale and the depression scale for schizophrenia at baseline , the posttest , and at a @-month follow-up .


Thirty-eight patients in the MIG and @ in the UCG completed the study .


After @ sessions of group music therapy , the groups showed statistically significant differences in psychiatric symptoms ( p < @ ) and depression status ( p < @ ) .


Group music therapy is an economical and easily implemented method of improving depression and psychiatric symptoms in patients with schizophrenia .


The Stroke Oxygen Study ( SOS ) is a multi-center randomized controlled trial of oxygen supplementation in patients with acute stroke .


The main hypothesis for the trial is that fixed-dose oxygen treatment during the first @ days after an acute stroke improves outcome .


The secondary hypothesis is that restricting oxygen supplementation to night time only is more effective than continuous supplementation .


This paper describes the statistical analysis plan for the study .


Patients ( n = @ ) are randomized to three groups : ( @ ) continuous oxygen supplementation for @ hours ; ( @ ) nocturnal oxygen supplementation for three nights ; and ( @ ) no routine oxygen supplementation .


Outcomes are recorded at @ days , @ days , @ months , and @ months .


The primary outcome measure is the modified Rankin scale at @ days .


Data will be analyzed according to the intention-to-treat principle .


Methods of statistical analysis are described , including the handling of missing data , the covariates used in adjusted analyses , planned subgroups analyses , and planned sensitivity analyses .


There has been no nationwide epidemiological investigation of allergic rhinitis ( AR ) that was diagnosed by both questionnaires and laboratory tests in Korea .


This study investigated the prevalence , risk factors , and comorbidities of AR in South Korea .


The Korean National Health and Nutritional Examination Survey examined a representative sample of the Korean population .


A total of @ participants underwent immunoradiometric assay for specific IgE antibodies against common indoor allergens .


Healthy , atopy only , and AR groups were defined according to the results of allergen test .


The weighted prevalence for each group was calculated .


Risk factors including food and comorbidities were identified using univariate or multivariate analyses .


The patients were also categorized into four subgroups according to the Allergic Rhinitis and Its Impact on Asthma ( ARIA ) classification and associated comorbidities were analyzed .


The prevalence of atopy only and AR was @ @ % and @ @ % , respectively .


The multivariate analysis showed that the prevalence was influenced by sex ( p < @ ) for atopy only and sex ( p = @ ) , age ( p = @ ) , marital status ( p = @ ) , and stress level ( p = @ ) for AR .


Compared with the healthy group , asthma ( odds ratio -LSB- OR -RSB- = @ ) , nasal polyp ( NP ; OR = @ ) , chronic rhinosinusitis ( OR = @ ) , and olfactory dysfunction ( OR = @ ) were more prevalent in the AR group .


Based on the ARIA guideline , intermittent mild rhinitis was most common ( @ % ) .


Asthma was correlated to severity and atopic dermatitis and NPs was associated with persistency .


Daily intake of less mackerel and more carrots , bread , and bean curd were associated with the increased risk of AR .


Prevalence , risk factors , and comorbidities of AR were evaluated in the general Korean population , which will contribute to prevention and treatment of AR and its comorbidities in Koreans .


Exercise training is recommended for non-cystic fibrosis ( CF ) bronchiectasis , but the long-term effects are unclear .


This randomised controlled trial aimed to determine the effects of exercise training and review of airway clearance therapy ( ACT ) on exercise capacity , health related quality of life ( HRQOL ) and the incidence of acute exacerbations in people with non-CF bronchiectasis .


Participants were randomly allocated to @weeks of supervised exercise training and review of ACT , or control .


Primary outcomes of exercise capacity and HRQOL ( Chronic respiratory disease questionnaire ) and secondary outcomes of cough-related QOL ( Leicester cough questionnaire ) and psychological symptoms ( Hospital anxiety and depression scale ) were measured at baseline , following completion of the intervention period and at @ and @months follow up .


Secondary outcomes of the exacerbation rate and time to first exacerbation were analysed over @months .


Eighty-five participants ( mean FEV@ @ % predicted ; median Modified Medical Research Council Dyspnoea grade of @ ( IQR -LSB- @-@ -RSB- ) were included .


Exercise training increased the incremental shuttle walk distance ( mean difference to control @m , @ % CI @ to @m ) and the @-minute walking distance ( mean difference to control @m , @ % CI @ to @m ) , but these improvements were not sustained at @ or @months .


Exercise training reduced dyspnoea ( p = @ ) and fatigue ( p = @ ) but did not impact on cough-related QOL or mood .


Exercise training reduced the frequency of acute exacerbations ( median @ -LSB- IQR @-@ -RSB- ) compared to the control group ( @ -LSB- @-@ -RSB- ) over @months follow up ( p = @ ) , with a longer time to first exacerbation with exercise training of @months ( @ % CI @ to @months ) compared to the control group ( @months -LSB- @ % CI @ to @months -RSB- , p = @ ) .


Exercise training in bronchiectasis is associated with short term improvement in exercise capacity , dyspnoea and fatigue and fewer exacerbations over @months .


Failure to return to pregnancy weight by @ months postpartum is associated with long-term obesity , as well as adverse health outcomes .


This research evaluated a postpartum weight management programme for women with a body mass index ( BMI ) > @ kg m ( -@ ) that combined behaviour change principles and a low-intensity delivery format with postpartum nutrition information .


Women were randomised at @-@ weeks to control ( supported care ; SC ) or intervention ( enhanced care ; EC ) groups , stratified by BMI cohort .


At @ weeks of gestation , SC women received a ` nutrition for breastfeeding ' resource and EC women received a nutrition assessment and goal-setting session about post-natal nutrition , plus a @-month correspondence intervention requiring return of self-monitoring sheets .


Weight change , anthropometry , diet , physical activity , breastfeeding , fasting glucose and insulin measures were assessed at @ weeks and @ months postpartum .


Seventy-seven percent ( @ EC and @ SC ) of the @ women approached were recruited ; @ EC and @ SC women received a programme and @ % and @ % completed the study , respectively .


No significant differences were observed between any outcomes .


Median -LSB- interquartile range ( IQR ) -RSB- weight change was EC : -@ ( @ ) kg versus SC : -@ ( @ ) kg ( @ weeks to @ months ) and EC : +@ ( @ ) kg versus SC : +@ ( @ ) kg ( prepregnancy to @ months ) .


Intervention women breastfed for half a month longer than control women ( @ versus @ days ; P = @ ) .


An average of @ out of six activity sheets per participant was returned .


Despite low intervention engagement , the high retention rate suggests this remains an area of interest to women .


Future strategies must facilitate women 's engagement , be individually tailored , and include features that support behaviour change to decrease women 's risk of chronic health issues .


The aim of the present study was to compare two novel fine structure strategies `` FS@ '' and `` FS@-p '' with the established fine structure processing ( FSP ) strategy .


FS@ provides fine structure information on the apical four-electrode channels .


With FS@-p , these electrodes may be stimulated in a parallel manner .


The authors evaluated speech perception , sound quality , and subjective preference .


A longitudinal crossover study was done on postlingually deafened adults ( N = @ ) who were using FSP as their default strategy .


Each participant was fitted with FS@ , FS@-p , and FSP , for @ months in a randomized and blinded order .


After each run , an Adaptive Sentence test in noise ( Oldenburger Sentence Test -LSB- OLSA -RSB- ) and a Monosyllable test in quiet ( Freiburger Monosyllables ) were performed , and subjective sound quality was determined with a Visual Analogue Scale .


At the end of the study the preferred strategy was noted .


Scores of the OLSA did not reveal any significant differences among the three strategies , but the Freiburger test showed a statistically significant effect ( p = @ ) with slightly worse scores for FS@ ( @ % ) compared with FSP ( @ % ) .


Performance of FS@-p ( @ % ) was comparable with the other strategies .


Both audiometric tests depicted a high variability among subjects .


The number of best-performing strategies for each participant individually was as follows : ( a ) for the OLSA : FSP , N = @ ; FS@ , N = @ ; and FS@-p , N = @ ; and ( b ) for the Freiburger test : FSP , N = @ ; FS@ , N = @ ; and FS@-p , N = @ .


A moderate agreement was found in the best-performing strategies of the Speech tests within the participants .


For sound quality , speech in quiet , classical , and pop music were assessed .


No significant effects of strategy were found for speech in quiet and classical music , but auditory impression of pop music was rated as more natural in FSP compared with FS@ ( p = @ ) .


It is interesting that at the end of the study , a majority of the participants favored the new coding strategies over their previous default FSP ( FSP , N = @ ; FS@ , N = @ ; FS@-p , N = @ ) .


In summary , FS@ and FS@-p offer new and further options in audio processor fitting , with similar levels of speech understanding in noise as FSP .


This is an interesting result , given that the strategies ' presentation of temporal fine structure differs from FSP .


At the end of the study , @ of @ subjects chose either FS@ or FS@-p over their previous default strategy FSP .


While alcohol intoxication is known to increase disinhibited behavior , the degree to which disinhibition occurs appears to depend on a number of factors including executive functioning ability .


However , the neural mechanisms by which individual differences in executive functioning lead to variable degrees of disinhibition remain unclear .


The aim of the current study was to examine the neural mechanisms by which individual differences in working memory ( WM ) capacity moderate alcohol-induced disinhibition .


Seventeen heavy-drinking males participated in a within-subjects design in which two sessions were completed : an alcohol session ( @ g/kg ) and a control session .


Participants completed a go/no-go task while undergoing functional magnetic resonance imaging ( fMRI ) after ingestion of the control or alcohol beverage .


WM capacity was measured using an operation span task .


Significant interactions of session and WM capacity emerged in contrasts examining successful response inhibition within superior temporal gyrus and unsuccessful inhibition in regions within the default mode network .


In all cases , individuals with low WM capacity demonstrated a relative decrease in blood oxygen level-dependent ( BOLD ) response during the alcohol compared to control session , whereas the high-WM-capacity group demonstrated relative increases in BOLD response in the alcohol compared to control session .


Low WM capacity appears to be associated with decreased neural response to signals indicating a need for behavioral control , an effect that may lead to increased difficulty with inhibiting responses and increased negative consequences from alcohol intoxication .


Individuals with substance use disorders ( SUDs ) experience increased smoking-related morbidity and mortality but severely compromised smoking treatment benefits .


Residential SUD treatment settings may be particularly positioned to target smoking , with ever-increasing smoking bans and culture shifts , but most smokers continue smoking .


This study examined the effects of contingency management ( CM ) for increasing smoking abstinence in residential patients .


Smokers interested in quitting were recruited from a residential SUD program for men and were randomized to frequent smoking monitoring with behavioral support ( monitoring ; n = @ ) or that plus smoking abstinence-contingent ( expired carbon monoxide -LSB- CO -RSB- @ ppm ; urinary cotinine @ng/ml ) incentives ( CM , n = @ ) for @ weeks .


After setting a quit date , procedures included daily behavioral support and smoking self-reports , @ CO samples ( a.m. / p.m. ) Monday through Friday , and cotinine tests on Mondays .


CM participants received escalating draws for prizes ( $ @ , $ @ , and $ @ values ) for negative tests ; positive and missed samples reset draws .


Follow-ups involved samples , self-reported smoking , and self-efficacy ( weeks @ , @ , @ , and @ ) .


Percent days CO-negative was higher with CM ( median -LSB- interquartile range -RSB- @ % -LSB- @ % -RSB- ) compared to monitoring ( @ % -LSB- @ % -RSB- ) ( p = @ ) .


Cigarettes per day declined and point-prevalence abstinence increased through follow-up ( p < @ ) , without significant group by time effects ( p > @ ) .


Abstinence self-efficacy increased overall during the intervention and more with CM compared to monitoring and was associated with abstinence across conditions through follow-up .


CM improved some measures of response to smoking treatment in residential SUD patients .


To observe the efficacy of Jianbu Tongluo Xunzheng Liquid ( JTXL ) in treating knee osteoarthritis ( KOA ) , and to explore the correlation between changes of infrapatellar fat pad scanned by CT and the efficacy .


Totally @ KOA outpatients were randomly assigned to three groups , i.e. , the treatment group , the control group , and the combination group , @ in each group .


Patients in the treatment group were fumigated by JTXL , @ min each time , once daily , @ times as a course of treatment , @ courses in total .


Those in the control group received intra-articular injection of Sodium Hyaluronate Injection ( SHI ) , @ mL each time , once per @ days , @ times in total .


Those in the combination group were treated by fumigation of JTXL + intra-articular injection of SHI in the same way as the aforesaid two groups .


All patients were treated for @ days .


Their clinical efficacy and changes of infrapatellar fat pad scanned by CT were observed , and their correlation was analyzed .


The total effective rate was @ % in the combination group , better than that of the control group ( @ % ) and the treatment group ( @ % ; both P < @ ) .


Besides , the score for knee joint functions at Hospital for Special Surgery ( HSS ) was better in the combination group than the other two groups ( P < @ ) .


The anteroposterior diameter , exterior-interior diameter , the superior-inferior diameter were shortened , and the density decreased in the treatment group and the combination group ( P < @ ) .


Besides , they were superior to those of the control group ( P < @ ) .


Changes of infrapatellar fat pad scanned by CT only existed in the combination group and the treatment group , indicating changes of CT scanning was only correlated with effect on changing physicochemical properties of infrapatellar fat pad .


Treatment by Chinese medicine could omnipotently and balanced regulate functions and structures of every tissue .


Therefore , CT could be taken as a better method for clinical efficacy observation by Chinese medicine .


To evaluate therapeutic efficacy upon augmenting the initial communication to patients regarding the diagnosis of psychogenic nonepileptic seizures ( PNES ) with a novel , brief group psychoeducation administered by the same team that provided the video-electroencephalography ( VEEG ) confirmed diagnosis and within @ weeks of the diagnosis .


Prior to discharge from the epilepsy monitoring unit ( EMU ) , a standardized communication strategy was utilized to explain the diagnosis of PNES to all patients prior to enrollment .


Enrolled patients were then randomized to either participation in three successive and monthly group psychoeducational sessions ( intervention group ) , or routine seizure clinic follow-up visits ( control group ) .


Both groups completed questionnaires at time of enrollment , and then at approximately @ months ( follow-up @ ) and @ months ( follow-up @ ) after discharge , assessing for : ( @ ) primary outcomes that include a measure of psychosocial functioning , as well as interval difference in seizure frequency/intensity ; and ( @ ) secondary outcomes that include interval seizure-related emergency room visits or hospitalizations , development of new and medically unexplained symptoms , and results of an internal measure of knowledge and perception outcomes .


The majority ( @ % ) of patients from the intervention group commenced on therapy sessions within @ weeks after learning of the diagnosis .


Although we did not observe significant group difference in seizure frequency/intensity , patients from the intervention group showed significant improvement on the Work and Social Adjustment Scale ( WSAS ) scores at both follow-up @ ( p = @ ) and follow-up @ ( p = @ ) after discharge from the EMU .


In addition , we observed a trend toward lesser likelihood for seizure-related emergency room visits or hospitalizations for the intervention group ( p = @ ) , as well as meaningful insights from an internal measure of intervention outcomes .


These findings suggest that our cost/resource effective , brief group psychoeducational program , when administered early and by the same team who confirmed and communicated the diagnosis of PNES , may contribute to significant functional improvement among participating patients .


Few studies have considered the retention of the individuals ( alters ) comprising the social networks of people in recovery .


The purpose of this study was to describe factors predicting whether alters were retained @ months after participants completed treatment .


The Important Person Inventory was given to @ ex-offenders ( @ men , @ women ) transitioning from treatment to Oxford House residences , Safe Haven therapeutic communities , or to usual aftercare .


A @-month follow-up was completed by @ participants ( @ men , @ women ) .


We found that alters who were related to the participant , did not use drugs , were embedded in smaller networks , and had more frequent contact with the participant were significantly more likely to be retained as important people over @ months .


The alters ' drinking and criminal history were not significantly predictive of retention in the network .


Certain characteristics of important people are related to their retention in a social network .


Understanding these relationships and the extent to which the network change that occurs is aligned with abstinence-supporting networks is essential for creating effective social interventions for persons in recovery .


A clinical randomized controlled trial .


This study sought to compare the clinical effectiveness of CT-guided nucleoplasty , CT-guided nucleoplasty combined with nerve root injection , and CT-guided transforaminal lumbar epidural injections in treating patients with contained lumbar disk herniation and leg pain , which are caused by radicular encroachment .


Lumbar disk herniation is the most common cause of nerve root pain .


The conservative treatment is proved to be effective for the majority of these patients , and the remaining patients are not ideal surgical candidates .


Studies have found that minimally invasive percutaneous disk procedures may be preferable to open surgery in certain clinical situations .


However , nucleoplasty in treating contained lumbar disk herniation and leg pain caused by radicular encroachment is still a controversy .


A total of @ patients with leg pain and MRI evidence of small-sized or medium-sized herniated disks correlating with the symptoms participated in the study .


The patients were randomly allocated into @ groups : the CT-guided nucleoplasty group ( N = @ ) , the CT-guided nucleoplasty with nerve root injection group ( N = @ ) , and CT-guided transforaminal lumbar epidural injections group ( N = @ ) .


Numeric Rating Scale ( NRS ) pain score and Oswestry Disability Index ( ODI ) values were applied at pretreatment and @ week , @ month , @ months , and @ months at posttreatment .


There were statistically significant decreases ( P = @ ) in the NRS and ODI scores for all posttreatment time points when compared with the pretreatment values in all the @ groups .


The average NRS and ODI results for the transforaminal lumbar epidural injections group were significantly higher than those for the other @ groups at @ and @ months posttreatment ( P < @ ) .


The combination of nucleoplasty with nerve root injection produced a significantly greater reduction in the NRS and ODI scores when compared with nucleoplasty at @ week ( P = @ for NRS and P = @ for ODI ) and @ month ( P = @ for NRS and P = @ for ODI ) after the treatment .


The results of this study suggest that CT-guided nucleoplasty with radiofrequency energy is a relative effective and safe technique for treating leg pain caused by radicular encroachment .


Furthermore , nucleoplasty combined with nerve root injection had achieved a significant greater improvement in pain management and functional level in short term ( within @ mo ) after treatment than nucleoplasty alone .


Endovascular or intra-arterial treatment ( IAT ) increases the likelihood of recanalization in patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion .


However , a beneficial effect of IAT on functional recovery in patients with acute ischemic stroke remains unproven .


The aim of this study is to assess the effect of IAT on functional outcome in patients with acute ischemic stroke .


Additionally , we aim to assess the safety of IAT , and the effect on recanalization of different mechanical treatment modalities .


A multicenter randomized clinical trial with blinded outcome assessment .


The active comparison is IAT versus no IAT .


IAT may consist of intra-arterial thrombolysis with alteplase or urokinase , mechanical treatment or both .


Mechanical treatment refers to retraction , aspiration , sonolysis , or use of a retrievable stent ( stent-retriever ) .


Patients with a relevant intracranial proximal arterial occlusion of the anterior circulation , who can be treated within @hours after stroke onset , are eligible .


Treatment effect will be estimated with ordinal logistic regression ( shift analysis ) ; @ patients will be included in the trial for a power of @ % to detect a shift leading to a decrease in dependency in @ % of treated patients .


The primary outcome is the score on the modified Rankin scale at @days .


Secondary outcomes are the National Institutes of Health stroke scale score at @hours , vessel patency at @hours , infarct size on day @ , and the occurrence of major bleeding during the first @days .


If IAT leads to a @ % absolute reduction in poor outcome after stroke , careful implementation of the intervention could save approximately @ % of all new stroke cases from death or disability annually .


Listening to music is a low-cost intervention that has demonstrated ability to reduce pain and anxiety levels in various medical procedures .


Subjects undergoing electrophysiological examinations were randomized into a music-listening group and a control group .


Visual analog scales were used to measure anxiety and pain levels during the procedure .


Thirty subjects were randomized to each group .


No statistically significant difference was found in anxiety or pain levels during the procedure between groups .


However , most subjects in the music-listening group reported anxiety and pain reduction and would prefer to hear music in a future examination .


Although listening to music during electrophysiological examinations did not reduce anxiety or pain significantly , most subjects felt a positive effect and would prefer to hear music ; therefore , we suggest that music may be offered optionally in the electromyography laboratory setting .


The incidence and prognostic impact of late bleeding complications after transcatheter aortic valve replacement ( TAVR ) are unknown .


The aim of this study was to identify the incidence , predictors , and prognostic impact of major late bleeding complications ( MLBCs ) ( @ days ) after TAVR .


Clinical and echocardiographic outcomes of patients who underwent TAVR within the randomized cohorts and continued access registries in the PARTNER ( Placement of Aortic Transcatheter Valves ) trial were analyzed after stratifying by the occurrence of MLBCs .


Predictors of MLBCs and their association with @-day to @-year mortality were assessed .


Among @,@ patients who underwent TAVR and survived to @ days , MLBCs occurred in @ ( @ % ) at a median time of @ days ( interquartile range : @ to @ days ) after the index procedure .


Gastrointestinal complications ( n = @ -LSB- @ % -RSB- ) , neurological complications ( n = @ -LSB- @ % -RSB- ) , and traumatic falls ( n = @ -LSB- @ % -RSB- ) were identified as the most frequent types of MLBCs .


Independent predictors of MLBCs were the presence of low hemoglobin at baseline , atrial fibrillation or flutter at baseline or @ days , the presence of moderate or severe paravalvular leak at @ days , and greater left ventricular mass at @ days .


MLBCs were identified as a strong independent predictor of mortality between @ days and @ year ( adjusted hazard ratio : @ ; @ % confidence interval : @ to @ ; p < @ ) .


MLBCs after TAVR were frequent and associated with increased mortality .


Better individualized and risk-adjusted antithrombotic therapy after TAVR is urgently needed in this high-risk population .


( THE PARTNER TRIAL : Placement of AoRTic TraNscathetER Valve Trial ; NCT@ ) .


Phonemic verbal fluency ( PVF ) is a cognitive function that involves serial processes termed clustering and switching and which is impacted in both normal aging and dementia .


The cognitive reserve hypothesis suggests that appropriate cognitive stimulation could maintain or improve cognitive performance .


This study examines the effect on PVF performance of a brief crossword-based intervention in a cognitively normal , community-based sample .


Thirty-seven members of active retirement groups volunteered to participate and were randomly assigned to a crossword group and a control group .


The former attempted a crossword daily for @weeks while the latter kept a daily gratitude diary for the same period .


@ mixed analyses of variance revealed that the crossword group performed significantly better over time than the control group in both total PVF score and in the cluster size component .


Daily crosswords may be a simple and effective means of bolstering PVF performance in older people .


Metabolic syndrome and depression seem to share some common underlying mechanisms , although less is known about the impact of metabolic syndrome dietary treatments on depression .


This study examined the association between a hypocaloric treatment designed to reduce metabolic syndrome features in self-perceived depression and the potential involvement of dietary components and oxidative stress changes .


Analyses were based on volunteers ( n = @ ) with metabolic syndrome ( age @ @ y.o. ; @M/@F ) , where depressive symptoms were assessed using the Beck Depression Inventory .


Participants followed two hypocaloric diets ( control diet and RESMENA diet ) with the same energy restriction ( -@ % TCV ) for six months .


Depressive symptoms , dietary records , anthropometrical measurements , biochemical parameters and oxidative stress levels were analysed .


Both diets improved self-perceived depression similarly ( p = @ ) .


Participants with lower depressive symptoms at baseline reported a significantly higher intake of omega-@ polyunsaturated fatty acids ( p trend = @ ) .


Interestingly , after adjusting for potential confounders , the increase in folate consumption ( p = @ ) and the decrease in plasma malondialdehyde levels ( p = @ ) throughout the intervention , were associated with the improvement in depressive symptoms .


A higher intake of folate and a decline in malondialdehyde plasma levels during a weight loss intervention , were related to improvements in manifestations of depression ( www.clinicaltrials.gov ; NCT@ ) .


To investigate the effect of somatostatin and dexamethasone on early postoperative small bowel obstruction with obliterative peritonitis ( EPSBO-OP ) .


This prospective randomized study included @ patients diagnosed with EPSBO-OP from June @ to January @ .


Patients were randomized into two groups : a control group received total parenteral nutrition and nasogastric ( NG ) tube feeding ; and an intervention group received , in addition , somatostatin and dexamethasone treatment .


The primary endpoints were time to resolution of bowel obstruction and length of hospital stay , and the secondary endpoints were daily NG output and NG feeding duration , treatment-related complications , postoperative obstruction relapse , and patient satisfaction .


Thirty-six patients were allocated to the intervention group and @ to the control group .


No patient needed to undergo surgery .


Patients in the intervention group had an earlier resolution of bowel obstruction ( @ @ vs @ @ d , P = @ ) .


Lower daily NG output ( @ @ vs @ @ mL/d , P < @ ) , shorter duration of NG tube use ( @ @ vs @ @ d , P < @ ) , and shorter length of hospital stay ( @ vs @ d , P = @ ) were observed in the intervention group .


The rate of treatment-related complications ( P = @ ) and relapse of obstruction ( P = @ ) were comparable between the two groups .


There were no significant differences in postoperative satisfaction at @ , @ and @ years between the two groups .


Somatostatin and dexamethasone for EPSBO-OP promote resolution of obstruction and shorten hospital stay , and are safe for symptom control without increasing obstruction relapse .


Despite the health risks , physical inactivity is common .


Identifying the correlates of physical activity to inform the design of interventions to reduce the disease burden associated with physical inactivity is a public health imperative .


Rural adults have a unique set of characteristics influencing their activity behaviour , and are typically understudied , especially in England .


The aim of this study was to identify the personal , social , and environmental correlates of physical activity in adults living in rural villages .


The study used baseline data from @ adults ( response rate : @ % ) participating in the first time period of a stepped-wedge cluster randomised trial , conducted in @ rural villages from south-west England .


Data collected included demographic characteristics , social factors , perception of the local environment , village level factors ( percentage male , mean age , population density , Index of Multiple Deprivation , and sport market segmentation ) , and physical activity behaviour .


Random effects ( `` multilevel '' ) logistic regression models were fitted to the binary outcome whether individuals met physical activity guidelines , and random effects linear regression models were fitted to the continuous outcome MET-minutes per week leisure time physical activity , using the personal , social , environmental , and village-level factors as predictors .


The following factors both increased the odds of meeting the recommended activity guidelines and were associated with more leisure-time physical activity : being male ( p = @ ) , in good health ( p < @ ) , greater commitment to being more active ( p = @ ) , favourable activity social norms ( p = @ ) , greater physical activity habit ( p < @ ) , and recent use of recreational facilities ( p = @ ) .


In addition , there was evidence ( p < @ ) that younger age , lower body mass index , having a physical occupation , dog ownership , inconvenience of public transport , and using recreational facilities outside the local village were associated with greater reported leisure-time physical activity .


None of the village-level factors were associated with physical activity .


This study adds to the current literature on the correlates of physical activity behaviour by focusing on a population exposed to unique environmental conditions .


It highlights potentially important correlates of physical activity that could be the focus of interventions targeting rural populations , and demonstrates the need to examine rural adults separately from their urban counterparts .


Living in a prediabetes state significantly increases a patient 's risk for both diabetes and cardiovascular disease .


Tianqi capsule , containing @ Chinese herbal medicines , is used in China for the treatment of type @ diabetes mellitus ( T@DM ) .


The purpose of this study was to assess whether Tianqi prevented T@DM in subjects with impaired glucose tolerance ( IGT ) over the course of a @-month treatment .


Individuals with IGT were randomly allocated in a double-blind manner to receive Tianqi ( n = @ ) or a placebo ( n = @ ) for @ months .


Oral glucose tolerance tests were conducted every @ months to assess the development of diabetes or restoration to normal glucose tolerance .


All subjects received the same lifestyle education .


The primary endpoint was the conversion of IGT to T@DM .


Body weight and body mass index were observed .


Adverse effects were monitored .


Of the @ enrolled subjects with IGT , @ completed the trial ( @ in the Tianqi group and @ in the placebo group ) .


At the end of the @-month trial , @ subjects in the Tianqi group ( @ % ) and @ in the placebo group ( @ % ) had developed diabetes ( P = @ ) .


There was a significant difference in the number of subjects who had normal glucose tolerance at the end of the study between the Tianqi and placebo groups ( n = @ , @ % , and n = @ , @ % , respectively ; P = @ ) .


Cox 's proportional hazards model analysis showed that Tianqi reduced the risk of diabetes by @ % compared with the placebo .


No severe adverse events occurred in the trial .


There were no statistical differences in body weight and body mass index changes between the Tianqi group and the placebo group during the @-month trial .


Treatment with a Tianqi capsule for @ months significantly decreased the incidence of T@DM in subjects with IGT , and this herbal drug was safe to use .


Orthostatic hypotension commonly accompanies supine hypertension , and is associated with low @-hydroxyvitamin D levels .


We tested whether high-dose intermittent oral vitamin D therapy could ameliorate orthostatic hypotension in older patients with isolated systolic hypertension .


We conducted a subgroup analysis of data from a parallel-group , double-blind , randomized , placebo-controlled trial .


Patients aged over @ years with supine office SBP above @mmHg and DBP below @mmHg received @ units oral vitamin D@ or matching placebo every @ months for @ year .


Office supine and standing blood pressure were measured at baseline , and @ , @ , @ and @ months , along with arterial stiffness and flow-mediated dilatation of the brachial artery .


Of @ patients randomized to the main trial , @ patients with orthostatic hypotension at baseline were included in this analysis .


The mean age was @ ( SD @ ) years , baseline blood pressure was @/@mmHg and the mean baseline orthostatic fall in blood pressure on standing was @/@mmHg .


After adjustment for baseline age , @-hydroxyvitamin D , SBP and orthostatic fall , the fall in SBP was less in the vitamin D group at @ months -LSB- treatment effect @mmHg , @ % confidence interval ( CI ) @ to @ -RSB- , but repeated-measures analysis showed no significant treatment effect ( @mmHg for systolic fall , @ % CI -@ to @ ; @mmHg for diastolic fall , @ % CI -@ to @ ) .


Twelve months of intermittent , high-dose oral vitamin D@ did not significantly improve orthostatic hypotension in older patients with isolated systolic hypertension .


Early prediction of the expected benefit of treatment in recurrent ovarian cancer ( ROC ) patients may help in drug development decisions .


The actual value of @ % CA-@ decrease is being reconsidered .


The main objective of the present study was to quantify the links between longitudinal assessments of CA-@ kinetics and progression-free survival ( PFS ) in treated recurrent ovarian cancer ( ROC ) patients .


The CALYPSO randomized phase III trial database comparing two platinum-based regimens in ROC patients was randomly split into a `` learning dataset '' and a `` validation dataset '' .


A parametric survival model was developed to associate longitudinal modeled CA-@ changes ( CA@ ) , predictive factors , and PFS .


The predictive performance of the model was evaluated with simulations .


The PFS of @ ROC patients were properly characterized by a parametric mathematical model .


The modeled CA@ from baseline to week @ was a better predictor of PFS than the modeled fractional change in tumor size .


Simulations confirmed the model 's predictive performance .


We present the first parametric survival model quantifying the relationship between PFS and longitudinal CA-@ kinetics in treated ROC patients .


The model enabled calculation of the increase in CA@ required to observe a predetermined benefit in PFS to compare therapeutic strategies in populations .


Therefore , CA@ may be a predictive marker of the expected gain in PFS and an early predictive tool in drug development decisions .


Drug-eluting balloons ( DEB ) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty ( PTA ) and improve wound healing/limb preservation .


The goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons ( IA-DEB ) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia ( CLI ) .


Within a prospective , multicenter , randomized , controlled trial with independent clinical event adjudication and angiographic and wound core laboratories @ CLI patients were randomized @:@ to IA-DEB or PTA .


The @ coprimary efficacy endpoints through @ months were clinically driven target lesion revascularization ( CD-TLR ) and late lumen loss ( LLL ) .


The primary safety endpoint through @ months was a composite of all-cause mortality , major amputation , and CD-TLR .


Clinical characteristics were similar between the @ groups .


Significant baseline differences between the IA-DEB and PTA arms included mean lesion length ( @ cm vs. @ cm ; p = @ ) , impaired inflow ( @ % vs. @ % ; p = @ ) , and previous target limb revascularization ( @ % vs. @ % ; p = @ ) .


Primary efficacy results of IA-DEB versus PTA were CD-TLR of @ % versus @ % ( p = @ ) and LLL of @ @ mm versus @ @ mm ( p = @ ) .


Primary safety endpoints were @ % versus @ % ( p = @ ) and met the noninferiority hypothesis .


A safety signal driven by major amputations through @ months was observed in the IA-DEB arm versus the PTA arm ( @ % vs. @ % ; p = @ ) .


In patients with CLI , IA-DEB had comparable efficacy to PTA .


While primary safety was met , there was a trend towards an increased major amputation rate through @ months compared to PTA .


( Study of IN.PACT Amphirion Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia -LSB- INPACT-DEEP -RSB- ; NCT@ ) .


We tested the efficacy of a minimal intervention to create smoke-free homes in low-income households recruited through the United Way of Greater Atlanta @-@-@ , an information and referral system that connects callers to local social services .


We conducted a randomized controlled trial ( n = @ ) from June @ through June @ , with follow-up at @ and @ months .


The intervention consisted of @ mailings and @ coaching call .


Participants were mostly smokers ( @ % ) , women ( @ % ) , African American ( @ % ) , and not employed ( @ % ) , with an annual household income of $ @,@ or less ( @ % ) .


At @-months postbaseline , significantly more intervention participants reported a full ban on smoking in the home than did control participants ( @ % vs @ % ; P = @ ) .


The intervention worked for smokers and nonsmokers , as well as those with or without children .


Minimal intervention was effective in promoting smoke-free homes in low income households and offers a potentially scalable model for protecting children and adult nonsmokers from secondhand smoke exposure in their homes .


This clinical trial evaluated the influence of denture adhesive ( DA ) use on masticatory function in denture wearers according to their denture-bearing ridge status .


Thirty edentulous subjects , wearing new well-fitting dentures , were classified as having either a normal or resorbed ridge .


Mastication was evaluated in patients who completed chewing tests with and without two DA substances ( cream or strips ) , which were randomly assigned .


A chewing test with a sieve method analyzed masticatory performance .


A kinesiographic device evaluated chewing cycle , and a visual analog scale measured masticatory ability .


Data were submitted to Mauchly 's sphericity test , and PROC MIXED procedures were conducted on repeated measures .


Tukey-Kramer tests performed appropriate statistical comparisons ( P @ ) .


DA use increased masticatory performance and ability in patients with both ridge types ( P < @ ) .


Subjects with resorbed ridges showed the best masticatory performance ( P < @ ) and lowest chewing cycle time ( P < @ ) with DA cream , followed by DA strips and the nonadhesive trial .


For normal ridge subjects , decreases in @ values were only significant with DA use ( P < @ ) , regardless of DA type .


The denture-bearing ridge status alone did not alter masticatory function in any of the parameters evaluated .


DAs improve mastication by shortening the chewing cycle and by enhancing chewing ability and performance .


We aimed to investigate the effect of @ % and @ % oxygen supplementation on maternal and neonatal oxidative stress in elective cesarean section ( CS ) under spinal anesthesia .


Eighty term parturients undergoing elective CS under spinal anesthesia were enrolled in the study .


We allocated patients randomly to breathe @ % ( air group ) or @ % ( oxygen group ) oxygen from the time of skin incision until the end of the operation .


We collected maternal pre - and post-operative and umbilical artery ( UA ) blood samples .


Total antioxidant capacity ( TAC ) , total oxidant status ( TOS ) and the oxidative stress index ( OSI ) were measured .


Age , weight , height , parity , gestation week , spinal-skin incision time , skin incision-delivery time , delivery time , operation time , @st and @th minutes Apgar scores , and birth weight were similar between the groups ( p > @ for all comparisons ) .


There were no differences in preoperative TAC , TOS , or OSI levels between the groups ( p > @ for all comparisons ) .


Postoperative maternal TAC , TOS and OSI levels significantly increased in the oxygen group ( p = @ , < @ and @ , respectively ) ; umbilical artery TAC levels significantly increased in the oxygen group ( p = @ ) ; and umbilical artery TOS and OSI levels significantly increased in the air group ( p = @ and < @ , respectively ) .


The difference in impact on maternal and fetal oxidative stress of supplemental @ % compared to @ % oxygen mandates further large-scale studies that investigate the role of oxygen supplementation during elective CS under spinal anesthesia .


It is important to distinguish children with different levels of severity of obstructive sleep apnea syndrome ( OSAS ) preoperatively using clinical parameters .


This can identify children who most need polysomnography ( PSG ) prior to adenotonsillectomy ( AT ) .


To assess whether a combination of factors , including demographics , physical examination findings , and caregiver reports from questionnaires , can predict different levels of OSAS severity in children .


Baseline data from @ children from the Childhood Adenotonsillectomy ( CHAT ) study were analyzed .


Children @ to @ years of age with PSG-diagnosed OSAS , who were considered candidates for AT , were included .


Polysomnography for diagnosis of OSAS .


Linear or logistic regression models were fitted to identify which demographic , clinical , and caregiver reports were significantly associated with the apnea hypopnea index ( AHI ) and oxygen desaturation index ( ODI ) .


Race ( African American ) , obesity ( body mass index z score > @ ) , and the Pediatric Sleep Questionnaire ( PSQ ) total score were associated with higher levels of AHI and ODI ( P = @ ) .


A multivariable model that included the most significant variables explained less than @ % of the variance in OSAS severity as measured by PSG outcomes .


Tonsillar size and Friedman palate position were not associated with increased AHI or ODI .


Models that tested for potential effect modification by race or obesity showed no evidence of interactions with any clinical measure , AHI , or ODI ( P > @ for all comparisons ) .


This study of more than @ children with OSAS identifies a number of clinical parameters that are associated with OSAS severity .


However , information on demographics , physical findings , and questionnaire responses does not robustly discriminate different levels of OSAS severity .


In a phase III , open-label , comparative , noninferiority study , @ subjects receiving de novo kidney transplants were randomized to one of three treatment arms : tacrolimus extended-release ( Astagraf XL ) qd , tacrolimus ( Prograf ) bid , or cyclosporine ( CsA ) bid .


All subjects received basiliximab induction , mycophenolate mofetil , and corticosteroids .


Safety and efficacy follow-up data through @ years are reported .


Evaluations included patient and graft survival , study drug discontinuations , laboratory values including renal function and development of new-onset diabetes after transplantation , concomitant medications , and adverse events .


At study termination , @ Astagraf XL , @ Prograf , and @ CsA patients had continued follow-up .


Demographic and baseline characteristics were similar in all arms .


Four-year Kaplan-Meier estimates of patient survival in the Astagraf XL , Prograf , and CsA groups were @ , @ , and @ % , respectively , while graft survival was @ , @ , and @ % , respectively .


At least one serious adverse event was reported in the majority of patients in each group during the study ( @ % Astagraf XL , @ % Prograf , and @ % CsA ) .


Renal function was not significantly different between Astagraf XL and Prograf .


HgbA@c levels were collected every @ months ; the @-year Kaplan-Meier estimate for incidence of HgbA@c levels @ % was significantly higher for both tacrolimus formulations compared to CsA ; @ % ( Astagraf XL ) , @ % ( Prograf ) , and @ % ( CsA ) .


In this @-year follow-up report , patients receiving Astagraf XL and Prograf showed comparable efficacy and safety profiles , with a higher incidence of new-onset diabetes after transplantation but superior renal function compared to patients receiving CsA .


The objective was to identify whether it was possible to change driver behavior by economic incentives and thereby reduce crash risk .


Furthermore , the objective was to evaluate the participants ' attitudes toward the pay-as-you-speed ( PAYS ) concept .


A one-year PAYS trial with economic incentives for keeping speed limits using intelligent speed assistance ( ISA ) was conducted in Sweden during @-@ .


The full incentive was a @ percent discount off the insurance premium .


The participants were private insurance customers and were randomized into a test group ( initial n = @ , final n = @ ) and a control group ( initial n = @ , final n = @ ) .


When driving , the drivers in the test group were informed and warned visually when the speed limit was exceeded .


They could also follow their driving results on a personal website .


The control group was not given any feedback at all .


To reflect the impact of the PAYS concept the proportion of distance driven above the speed limit was compared between the @ groups .


The introduction of a PAYS concept shows that the test group significantly reduced the proportion of distance driven above the speed limit .


The proportion of driving at a speed exceeding @ km/h over the speed limit was @ percent for the test group and @ percent for the control group .


It also showed that the effect was higher the higher the violation of speed .


The result remained constant over time .


It was shown that a PAYS concept is an effective way to reduce speed violations .


Hence , it has the possibility to reduce crash severity and thereby to save lives .


This could be an important step toward a safer road transport system .


The majority of the participants were in favor of the concept , which indicates the potential of a new insurance product in the future .


This study aimed to evaluate the effects of vitamin D intake on COPD exacerbation and FEV@ in the patients with severe and very severe COPD .


This double blind placebo control randomized clinical trial study was done in the Ashayer university hospital in Khorramabad in @ .


Eighty eight patients with severe and very severe COPD were randomly selected from those who recoursed to the internal medicine clinic of Ashayer hospital .


They were randomly allocated to case and placebo group .


The patients received routine treatment for COPD .


Along with the routine treatment , placebo group received @,@ IU of oral vitamin D per month , for @ months .


Data was analyzed using SPSS computer software , paired t-test , independent t-test , non parametric t-test and Pearson correlation coefficients .


In each group , there were @ patients .


After the intervention , there were significant differences in FEV@ and the number of COPD exacerbation between the case and control group patients .


Also , after the study , in the case group , FEV@ was increased and the number of COPD exacerbation was decreased significantly .


Vitamin D intake decreased COPD exacerbation and improved FEV@ in the patients with severe and very severe COPD .


It is suggested that baseline serum vitamin D levels will recorded in similar studies and the effect of vitamin D intake will evaluated regarding the baseline serum vitamin D levels .


Our research utilized two popular theoretical conceptualizations of implicit self-esteem : @ ) implicit self-esteem as a global automatic reaction to the self ; and @ ) implicit self-esteem as a context/domain specific construct .


Under this framework , we present an extensive search for implicit self-esteem measure validity among different cultural groups ( Study @ ) and under several experimental manipulations ( Study @ ) .


In Study @ , Euro-Canadians ( N = @ ) , Asian-Canadians ( N = @ ) , and Japanese ( N = @ ) completed a battery of implicit self-esteem , explicit self-esteem , and criterion measures .


Included implicit self-esteem measures were either popular or provided methodological improvements upon older methods .


Criterion measures were sampled from previous research on implicit self-esteem and included self-report and independent ratings .


In Study @ , Americans ( N = @ ) completed a shorter battery of these same types of measures under either a control condition , an explicit prime meant to activate the self-concept in a particular context , or prime meant to activate self-competence related implicit attitudes .


Across both studies , explicit self-esteem measures far outperformed implicit self-esteem measures in all cultural groups and under all experimental manipulations .


Implicit self-esteem measures are not valid for individual or cross-cultural comparisons .


We speculate that individuals may not form implicit associations with the self as an attitudinal object .


To find a threshold body weight ( BW ) below @ kg above which computed tomography pulmonary angiography ( CTPA ) using reduced radiation and a reduced contrast material ( CM ) dose provides significantly impaired quality and diagnostic confidence compared with standard-dose CTPA .


In this prospectively randomised study of @ patients with suspected pulmonary embolism and BW < @ kg , @ were allocated into the low-dose group ( @ kVp , @ ml CM ) and @ into the normal-dose group ( @ kVp , @ ml CM ) .


Contrast-to-noise ratio ( CNR ) in the pulmonary trunk was calculated .


Two blinded chest radiologists independently evaluated subjective image quality and diagnostic confidence .


Data were compared between the normal-dose and low-dose groups in five BW subgroups .


Vessel attenuation did not differ between the normal-dose and low-dose groups within each BW subgroup ( P = @ ) .


The CNR was higher with the normal-dose compared with the low-dose protocol ( P < @ ) in all BW subgroups except for the @-@ kg subgroup ( P = @ ) .


Subjective image quality and diagnostic confidence did not differ between CT protocols in all subgroups ( P between @ and @ ) .


Subjective image quality and diagnostic confidence with @ kVp CTPA is not different from normal-dose protocol in any BW group up to @ kg .


@ kVp CTPA is safe in patients weighing < @ kg Reduced radiation and iodine dose still provide high vessel attenuation Image quality and diagnostic confidence with low-dose CTPA is good Diagnostic confidence does not deteriorate in obese patients weighing < @ kg .


To investigate the efficacy of a two-week programme of repetitive exercise with cueing and movement strategies upon freezing of gait in people with Parkinson 's disease .


Randomized cross-over trial .


Specialist clinic for Parkinson 's disease .


A total of @ patients with Parkinson 's disease and freezing while other symptoms had favorably responded to dopaminergic treatment .


Patients were randomized into a four-week cross-over trial , and received either treatment ( Group @ ) or no treatment ( Group @ ) during Period @ , and switched during Period @ .


Treatment consisted of a two-week programme during which the patients exercised cueing , and movement strategies together with a physiotherapist .


The primary outcome measure was a freezing score assessed from blinded and random ratings of video recordings .


The secondary outcome measure was a patient-reported freezing questionnaire .


Mean differences between the treatment periods ( treatment arms ) were evaluated for treatment ( period ) effects .


Sums of treatment periods were evaluated for carry-over effects .


The programme led to a significant treatment effect in the freezing score of @ improvement ( @ % confidence interval @-@ @ ; p < @ ) .


No carry-over or period effects were detected .


The questionnaire revealed a period effect , so groups were compared after Period @ , where a significant difference was found ( @ vs. @ ; p < @ ) .


The two-week physiotherapy programme reduced the severity of freezing in patients with Parkinson 's disease .


Internet-delivered interventions have proven efficacious in changing people 's behaviours and related determinants , but the actual use of these interventions by the target group is often very low .


This article investigates whether arousing interest and enjoyment results in increased intervention use in an online context .


Invitations to visit a website about Hepatitis A , B and C virus infections ( Studies @ and @ ) and the website itself ( Studies @ and @ ) were manipulated to arouse interest and enjoyment .


Intention to visit the website ( Study @ ) , clicking on the link to visit the website ( Studies @ and @ ) and the number of pages visited on the website ( Study @ ) .


Arousing interest through an invitation resulted in a higher intention to visit the website ( Study @ ) and a higher likelihood of clicking on the link to visit the website in comparison with arousing enjoyment ( Study @ ) .


The number of pages visited increased when interest was aroused on the website itself ( Study @ ) .


Arousing interest is a promising strategy to increase use of Internet-delivered interventions and potentially increase the public health impact of these interventions .


Pharmacokinetic changes have been found in critically ill patients , including ventilator-associated pneumonia ( VAP ) when compared with healthy volunteers leading to fluctuation of plasma concentrations .


To compare the probability of target attainment ( PTA ) and cumulative fraction of response ( CFR ) for meropenem between administration by a bolus injection and a @-hour infusion .


The study was a randomized three-way crossover in nine patients with VAP .


Each patient received meropenem in three regimens consecutively : ( i ) a bolus injection of @ g every eight hours ( q@h ) for @ hours ; ( ii ) a @-hour infusion of @ g q@h for @ hours ; and ( iii ) a @-hour infusion of @ g q@h for @ hours .


The pharmacodynamic analysis of meropenem was performed to determine the PTA by using the Monte Carlo simulation and the study used susceptibility patterns obtained from EUCAST and MYSTIC for assessment of CFR .


For an MIC of @ microg/ml , the PTAs achieving @ % T > MIC following a bolus injection of @ g q@h , a @-hour infusion of @ g q@h , and a @-hour infusion of @ g q@h were @ % , @ % , and @ % , respectively .


Only the @-hour infusion regimens were predicted to achieve a CFR > or = @ % against E. coli , Klebsiella spp. , P. aeruginosa , and Acinetobacter spp .


A @-hour infusion of @ g of meropenem regimen was predicted to have the highest PTA rates .


Only the prolonged infusion regimens achieved a high CFR against E. coli , Klebsiella spp. , P. aeruginosa , and Acinetobacter spp .


Eccentric training has been popularized for physical conditioning and prevention/rehabilitation of musculoskeletal disorders , especially due to the expressive responses in terms of muscular strength gain .


In view of evidence that low-level laser therapy ( LLLT ) is able to increase exercise performance and accelerate post-exercise recovery , the aim of this study was to verify the effect of LLLT on hypertrophy and strengthening of knee extensor muscles submitted to eccentric training .


Thirty healthy male subjects were randomized into three groups : Control Group ( CG ) , Training Group ( TG ) and Training + LLLT Group ( TLG ) .


CG received no intervention , while TG and TLG were engaged on an @-week knee extensor isokinetic eccentric training program .


Only subjects from TLG were treated with LLLT ( wavelength = @ nm ; power output = @ mW ; total dosage = @ J ) before each training session .


Knee extensor muscle thickness and peak torque were assessed through ultrasonography and isokinetic dynamometry , respectively .


CG presented no changes in any variable throughout the study , while eccentric training led to significant increases in muscle thickness and peak torque in TG and TLG .


Subjects from TLG reached significantly higher percent changes compared to subjects from TG for sum of muscles ' thicknesses ( @ vs. @ % ) , isometric peak torque ( @ vs. @ % ) , and eccentric peak torque ( @ vs. @ % ) .


LLLT applied before eccentric training sessions seems to improve the hypertrophic response and muscular strength gain in healthy subjects .


The Chuanhu anti-gout mixture has been used for many years in the treatment of gout in Chinese Traditional Medicine , and current methods for treatments for acute gouty arthritis have been either less effective or have had serious side effects .


In this @-week , double-blind , double-dummy , non-inferiority study , outpatient individuals with newly diagnosed acute gouty arthritis were randomly assigned to receive Chuanhu anti-gout mixture or colchicine .


Both the study investigators and the participants were masked to the treatment assignments .


The primary outcome was the recurrence rate of acute gouty arthritis , and the secondary outcomes were changes in white blood cells ( WHC ) and C-reactive protein ( CRP ) .


This trial is registered at ISRCTN.org as trial ISRCTN@ .


A total of @ patients were randomly assigned to receive either the Chuanhu anti-gout mixture or Colchicine .


The overall recurrence rates in the Chuanhu anti-gout mixture group ( CH group ) and the Colchicine group ( Col group ) were @ % vs @ % ( difference -@ % , @ % confidence interval ( @ % CI ) : -@ % ~ @ % ) , meeting the predefined non-inferiority criterion of @ % , as did the data for WHC and CRP .


The incidence of adverse events ( mainly diarrhea ) was less in the Col group than in the CH group ( @ % vs @ % , @ % CI @ ~ @ ) .


In addition , changes in blood uric acid , alanine aminotransferase , aspartate aminotransferase and creatinine in the CH group were significantly larger compared to those in the Col group ( P < @ ) .


The Chuanhu anti-gout mixture was non-inferior to colchicine for the treatment of acute gouty arthritis .


The study suggested that the Chuanhu anti-gout mixture can be considered an alternative choice for the treatment of acute gouty arthritis because of its lower incidence of adverse events and its protection of kidney and renal function .


Atherosclerotic peripheral artery disease ( PAD ) is common and results in limitations in quality of life and potential progression to limb loss .


Options for therapy include medical therapy , supervised exercise , surgical revascularization , and , more recently , endovascular therapies to restore arterial perfusion to the limb .


Endovascular revascularization has evolved over the past @ decades , from percutaneous transluminal angioplasty ( PTA ) to self-expanding stents , atherectomy , laser angioplasty , and drug-eluting stents .


Despite impressive technologic advances , PTA remains the standard of care at many institutions and is the recommended primary treatment modality for femoral-popliteal PAD according to current American College of Cardiology Foundation/American Heart Association guidelines .


However , restenosis after PTA is common .


Therefore , a significant clinical need remains for a device that is able to achieve more durable patency than PTA but does not require a permanent implant .


Drug-coated balloons ( DCBs ) have the potential to address this need .


Several randomized controlled clinical trials of PTA balloons coated with different formulations of paclitaxel have been conducted in Europe ( N Engl J Med @ ; @:@ -@ ) ( Circulation @ ; @:@ -@ ) ( Circ Cardiovasc Interv @ ; @:@ -@ ) ( JACC Cardiovas Interv @ ; @:@ -@ ) and demonstrated more durable efficacy than PTA with comparable safety .


These studies were limited by small sample sizes and powered solely for an angiographic primary end point .


The pivotal LEVANT @ trial was designed in collaboration with the US Food and Drug Administration to demonstrate safety and efficacy in a large population and to obtain US Food and Drug Administration approval .


A prospective , multicenter , single-blind trial comparing the Lutonix DCB ( Bard Lutonix ; New Hope , MN ) versus PTA for treatment of femoropopliteal PAD ( LEVANT @ ) is the first US-based @:@ randomized controlled trial of @ patients with femoral-popliteal PAD designed to demonstrate superior efficacy and noninferior safety of a novel paclitaxel DCB compared with PTA .


The primary efficacy end point is primary patency at @ months .


The primary safety end point is composite freedom at @ months from perioperative death , index limb amputation , reintervention , and limb-related mortality .


A series of important secondary end points include physical functioning , quality of life , revascularizations , and alternative measures of patency .


To minimize bias potential for confounding variables , LEVANT @ ( @ ) excluded patients stented after predilation before randomization , ( @ ) incorporated very stringent criteria for bailout stenting , ( @ ) did not count bailout stenting as a target lesion revascularization or failure of any end point , ( @ ) required a blinded clinician to perform clinical evaluations at follow-up , and ( @ ) required clinical assessment before review of duplex ultrasound results .


LEVANT @ represents the first US-inclusive multicenter , randomized controlled trial to assess the safety and efficacy of a novel DCB compared with PTA as primary therapy for symptomatic PAD on the background of standard medical therapy .


To evaluate the efficacy of endoscopy with a transparent cap on biopsy positioning in Barrett 's esophagus ( BE ) .


One hundred and sixty-eight patients with suspected BE at endoscopy were enrolled in our study from November @ to December @ and divided into two groups : transparent cap group ( n = @ ) and control group ( n = @ ) .


Endoscopy with or without a transparent cap and subsequent biopsy of suspected lesions were performed by five experienced endoscopists in our hospital .


In both groups , two biopsy specimens were taken from each patient , and the columnar epithelium or goblet cells in histological assessment were used as the diagnostic standard for BE .


In the transparent cap group , @ cases were tongue type , while @ and two cases were identified as island type and circumferential type , respectively .


In the control group , @ tongue-type cases were confirmed , with @ island-type and five circumferential-type cases .


Moreover , there was no significant difference with regard to the composition of endoscopic BE types in the two groups ( P > @ ) .


In the biopsy specimens , BE was detected in @ cases in the transparent cap group ( @ % , @/@ ) , whereas the detection rate in the control group ( @ % , @/@ ) was lower compared to that in the transparent cap group ( P < @ ) .


In addition , goblet cells were recognized in only eight cases ( all with columnar epithelium ) ( @/@ , @ % ) in the transparent cap group , with @ cases in the control group .


Transparent cap-fitted endoscopy can guide biopsy positioning in BE without other accompanying complications , thus increasing the detection rate of BE .


To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence ( SUI ) treatment .


This prospective single-center randomized controlled trial involved @ women with a diagnosis of SUI .


Primary outcomes were the objective and subjective cure rates , defined as negative cough stress and pad tests , and satisfaction rates .


Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form , operation time , complications , and reoperation rates were also recorded .


The efficacy was analyzed using a noninferiority test with a margin of @ % .


For the noninferiority test , a P value > @ rejects the noninferiority hypothesis of the mini-sling .


Sixty-four patients in the mini-sling group and @ in the transobturator group completed the @-month follow-up .


The objective cure rates for the mini-sling and the transobturator sling were @ % and @ % ( absolute difference @ ; @ % confidence interval -LSB- CI -RSB- @-@ @ ; P = @ ) and the subjective cure rates were @ % and @ % ( absolute difference @ % ; @ % CI @-@ @ ; P = @ ) , respectively .


There was a significant improvement in quality of life in both groups .


Thigh pain was greater after the transobturator sling , four patients ( @ % ) compared with zero ( P = @ ) .


The mean operation time was @ minutes shorter for the mini-sling procedure ( P = @ ) .


Five patients ( @ % ) in the mini-sling group and one patient ( @ % ) in the transobturator group underwent surgical reintervention for persistent SUI ( P = @ ) .


The noninferiority of the mini-sling could not be demonstrated in this study at the @-month follow-up .


The mini-sling was associated with shorter operative time and less postoperative thigh pain .


Various cytochrome P@ isoforms modulate sibutramine activity and influence sibutramine plasma levels and pharmacokinetics .


However , there are no available data to demonstrate the association of these polymorphisms with the clinical outcomes of sibutramine administration .


This study was a sub-investigation of a @-week , double-blind , placebo-controlled trial examining the additive effect of orlistat on sibutramine .


The final analysis was restricted to @ women who had fulfilled the protocol .


We evaluated the effects of genetic polymorphisms of CYP@A@ , CYP@C@ and CYP@B@ on the % weight loss and the occurrence of adverse events .


The change of pulse rate from baseline value was affected by both CYP@B@ and CYP@A@ genetic polymorphisms ( P < @ for CYP@A@ and P = @ for CYP@B@ ) .


Both CYP@B@ and CYP@A@ showed gene-gene interactions ( P < @ ) .


After adjusting for significant variables in the backward stepwise regression model , the change of pulse rate and time-dependent weight reduction were significant only among the CYP@B@ genotypes ( P = @ and P < @ , respectively ) .


The CYP@B@ * @ allele influences the extent of weight reduction and pulse rate changes in patients undergoing sibutramine treatment .


Enterotoxigenic Escherichia coli ( ETEC ) is a major cause of travellers ' diarrhoea .


We investigated the efficacy and safety of a skin-patch vaccine containing the pathogen 's heat-labile toxin ( LT ) in a population of travellers to Mexico and Guatemala .


In this phase @ , randomised , double-blind , placebo-controlled field trial , healthy adults ( aged @-@ years ) travelling from Germany or the UK to Mexico or Guatemala were assigned in a @:@ ratio by a dynamic electronic randomisation system to receive transcutaneous immunisation with a patch containing @ g of ETEC LT or a placebo patch .


Participants , site staff , and the investigators who did the analyses were masked to group assignment .


Participants were vaccinated before travel , with two patches given @ days apart .


In the destination country , participants tracked stool output in a diary and provided stool samples for pathogen identification if diarrhoea occurred .


The primary endpoint was the proportion of participants with at least one episode of moderate-to-severe diarrhoea ( defined as four or more unformed stools in a @ h period ) in which either or both ETEC enterotoxins ( LT and heat-stable toxin -LSB- ST -RSB- ) were detected .


The study is registered at ClinicalTrials.gov , number NCT@ .


@ participants were recruited and randomly assigned between Oct @ , @ , and Aug @ , @ , with @ allocated to receive the LT patch and @ the placebo patch .


@ participants in the LT-patch group and @ in the placebo group received both vaccinations and were analysed in the per-protocol population .


@ ( @ % , @ % CI @-@ @ ) participants in the LT-patch group and @ ( @ % , @-@ @ ) in the placebo group had moderate or severe ETEC diarrhoea ( vaccine efficacy @ % , -@ to @ ; p = @ ) .


@ local ( ie , patch-site ) adverse events ( including erythema , rash , pruritus , hyperpigmentation , pain , hypopigmentation , and oedema ) occurred in @ ( @ % ) of @ participants in the LT-patch group , compared with @ local adverse events in @ ( @ % ) of @ participants in the placebo group ( p < @ ) .


Serious adverse events occurred in @ participants ( @ in the LT-patch group and @ in the placebo group ) , with all regarded as either unrelated or possibly related to treatment .


Vaccine-induced hyperpigmentation persisted for at least @ days after vaccination in @ ( @ % ) of the @ participants who received both vaccinations and returned for final assessment in the LT-patch group , compared with none of the @ participants in the placebo group .


The vaccine was immunogenic , with a post-vaccination geometric mean titre of LT-specific serum immunoglobulin G of @ , compared with @ in the placebo group .


Although the LT antigen was delivered effectively by the skin patch , the vaccine did not protect travellers against diarrhoea caused by ETEC or other organisms .


Future vaccines against travellers ' diarrhoea might need to include several antigens against various diarrhoeal pathogens , and might need to be able to generate mucosal and higher systemic immunity .


There are several methods for postoperative analgesia for knee surgery .


The commonly utilized method is multimodal analgesia based on continuous femoral nerve block .


The aim of this study was to investigate the application of continuous adductor canal block for analgesia after total knee replacement and compare this method with continuous femoral nerve block .


Sixty patients scheduled for total knee replacement from June @ to March @ were randomly divided into a femoral group and an adductor group .


Catheters were placed under the guidance of nerve stimulation in the femoral group and under the guidance of ultrasound in the adductor group .


Operations were performed under combined spinal and epidural anesthesia .


After the operations , @ % ropivacaine was given at a speed of @ ml/h through catheters in all patients .


Visual analogue scale ( VAS ) pain scores at rest and while moving were noted at @ , @ , and @ hours after the operation , and quadriceps strength was also assessed at these time-points .


Secondary parameters such as doses of complementary analgesics and side effects were also recorded .


There were no significant differences between the groups in VAS pain scores at rest or while moving , at @ , @ , or @ hours after the operation ( P > @ ) .


At these time-points , mean quadriceps strengths in the adductor group were @ ( @-@ @ ) , @ ( @-@ @ ) , and @ ( @-@ @ ) , respectively , all of which were significantly stronger than the corresponding means in the femoral group , which were @ ( @-@ @ ) , @ ( @-@ @ ) , and @ ( @-@ @ ) , respectively ( P < @ ) .


There were no significant differences between the groups in doses of complementary analgesics or side effects ( P > @ ) .


X-ray images of some patients showed that local anesthetic administered into the adductor canal could diffuse upward and reach the femoral triangle .


Continuous adductor canal block with @ % ropivacaine could be used effectively for analgesia after total knee replacement .


Compared with continuous femoral nerve block , this analgesic method has similar analgesic effects and is associated with less weakness of quadriceps muscle .


Comparative effectiveness research ( CER ) has become a major focus of cardiovascular disease investigation to optimize diagnosis and treatment paradigms and decrease healthcare expenditures .


Acute chest pain is a highly prevalent reason for evaluation in the Emergency Department ( ED ) that results in hospital admission for many patients and excess expense .


Improvement in noninvasive diagnostic algorithms can potentially reduce unnecessary admissions .


To compare the performance of treadmill stress echocardiography ( SE ) and coronary computed tomography angiography ( CTA ) in ED chest pain patients with low-to-intermediate risk of significant coronary artery disease .


This is a single-center , randomized controlled trial ( RCT ) comparing SE and CTA head-to-head as the initial noninvasive imaging modality .


The primary outcome measured is the incidence of hospitalization .


The study is powered to detect a reduction in admissions from @ % to @ % with a sample size of @ .


Secondary outcomes include length of stay in the ED/hospital and estimated cost of care .


Safety outcomes include subsequent visits to the ED and hospitalizations , as well as major adverse cardiovascular events at @days and @year .


Patients who do not meet study criteria or do not consent for randomization are offered entry into an observational registry .


This RCT will add to our understanding of the roles of different imaging modalities in triaging patients with suspected angina .


It will increase the CER evidence base comparing SE and CTA and provide insight into potential benefits and limitations of appropriate use of treadmill SE in the ED .


Overactive bladder ( OAB ) is highly prevalent and is associated with considerable morbidity and reduced health-related quality of life .


@-adrenergic receptor ( @-AR ) stimulation is a novel alternative to antimuscarinic therapy for OAB .


The objective of this analysis was to assess the cost effectiveness of the @-AR agonist mirabegron relative to tolterodine extended release ( ER ) in patients with OAB from a UK National Health Service ( NHS ) perspective .


A Markov model was developed to simulate the management , course of disease , and effect of complications in OAB patients over a period of @years .


Transition probabilities for symptom severity levels and probabilities of adverse events were estimated from the results of the randomised , double-blind SCORPIO trial in @,@ patients with OAB .


Other model inputs were derived from the literature and on assumptions based on clinical experience .


Total @-year costs per patient were @,@ for mirabegron @mg/day and @,@ for tolterodine ER @mg/day .


Mirabegron was associated with a gain of @ quality-adjusted life-years ( QALYs ) with an additional cost of @ .


The resulting incremental cost-effectiveness ratio ( ICER ) was @,@ / QALY gained .


In deterministic sensitivity analyses in the general OAB population and several subgroups , ICERs remained below the generally accepted willingness-to-pay ( WTP ) threshold of @,@ / QALY gained .


The probability of mirabegron @mg being cost effective relative to tolterodine ER @mg was @ % at the same WTP threshold .


Mirabegron @mg/day is likely to be cost effective compared with tolterodine ER @mg/day for adult patients with OAB from a UK NHS perspective .


To compare the efficacy of mifepristone and ethacridine lactate with ethacridine lactate alone for second trimester pregnancy termination .


Two hundred and seventy-six healthy women between @ and @ weeks of gestation , desiring a termination , were assigned at random into two groups .