Greater systolic blood pressure visit-to-visit variability was associated independently with increased risk of the composite kidney disease end point ( HR per @-SD increment , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) and end-stage renal disease , but not with the cardiovascular outcome .


Observational study with the potential for confounding .


In diabetic individuals with nephropathy , systolic blood pressure visit-to-visit variability is associated independently with hard kidney disease outcomes .


To evaluate the effects of surface electrical stimulation ( SES ) and to compare them with the effects of the intravaginal electrical stimulation ( IVES ) in women with stress urinary incontinence ( SUI ) .


This randomized controlled study included @ women aged over @ years , who complained of SUI evaluated according to two structured questions of King 's Health Questionnaire ( KHQ ) and who had not previously undergone physical therapy for SUI .


The calculation of the sample size estimated a sample of @ volunteers with a significance level of @ % and statistical power of @ % .


The women were randomized to : Surface Electrical Stimulation Group ( SESG ) ( n = @ ) , Intravaginal Electrical Stimulation Group ( IVESG ) ( n = @ ) and Control Group ( CG ) ( n = @ ) .


Subjects in the intervention groups were treated with the same parameters of electrical stimulation for @ sessions .


The SESG had four silicone electrodes fixed in the suprapubic and ischial tuberosity regions .


The IVES group used an intravaginal electrode .


The CG did not receive any treatment during the corresponding time .


They were evaluated before and after treatment by a physical therapist who was blind to group allocation .


The primary outcomes were urinary leakage , pressure and strength of pelvic floor muscle ( PFM ) contraction .


The secondary outcome was quality of life ( QOL ) evaluated by KHQ .


Forty-five women completed the study and were included in the analysis .


Statistical analysis was performed using the Wilcoxon test for intragroup analysis and Kruskal-Wallis and Mann-Whitney tests for intergroup analysis ( p < @ ) .


There was significant improvement in urinary loss and pressure of contraction in the SESG and IVESG .


PFM strength increased only in the IVESG .


Intergroup analysis found differences after the treatment in : urinary leakage between the SESG and CG ( p < @ ) and the IVESG and CG ( p < @ ) .


Regarding QOL , there was significant reduction in the incontinence impact , limitations of daily activities , physical limitation , emotion , sleep and disposition and severity domains in the SESG ( all p < @ ) and IVESG ( all p < @ ) after the treatments .


SES and IVES are important treatments to improve the SUI .


Both improved the QOL , urinary leakage , and strength and pressure of PFM contraction .


Scarce data are available concerning effects of certain bioactive substances such as Maillard reaction products ( MRP ) on the gut microbiota composition , and the question of how a diet rich in MRP affects gut microbiota in humans is still open .


Two experiments were conducted .


In expt .


@ , adolescents consumed diets either high or low in MRP in a two-period crossover trial ; in expt .


@ , rats were fed diets supplemented or not with MRP model-systems .


Intestinal microbiota composition in fecal ( adolescents ) or cecal ( rat ) samples was assessed by qPCR analysis .


Negative correlations were found in the human assay between lactobacilli numbers and dietary advanced MRP ( r = -@ and -@ , for hydroxymethylfurfural and carboxymethyl-lysine respectively , p < @ ) , whereas bifidobacteria counts were negatively correlated with Amadori compounds intake .


In the rat assay , total bacteria and lactobacilli were negatively correlated with MRP intake ( r = -@ , -@ and -@ , for Amadori compounds , hydroxymethylfurfural and carboxymethyl-lysine respectively , p < @ ) , but no correlations were found with bifidobacteria .


Dietary MRP are able to modulate in vivo the intestinal microbiota composition both in humans and in rats , and the specific effects are likely to be linked to the chemical structure and dietary amounts of the different browning compounds .


The Americans with Disabilities Act set in motion a series of policies and actions to promote community integration and participation , including for those individuals with psychiatric disabilities .


Measuring participation in this population is in its infancy .


This study examines the test-retest reliability of two modes of administration of a measure that assesses participation in four social life domains and the extent to which participation is viewed as sufficient and important .


One hundred and @ individuals with a diagnosis of schizophrenia , bipolar disorder , or major depression were randomly assigned to either an interviewer - or self-administered method of completing the measure , and filled out the measure again in the same format within @-@ hr .


Correlations at the individual participation item and scale levels between the two time points were nearly all in the r = @ -@ range .


Agreement on the importance and sufficiency of their participation was also consistently high .


The importance of participation in each area ranged from @ % to @ % , and among these individuals , between @ % and @ % indicated they were not participating as much as desired .


Community participation of individuals with psychiatric disabilities can be reliably measured using @ methods of administration as an outcome in rehabilitation research and evaluation studies with this population .


These individuals are engaged to varying degrees in a wide-range of participation areas in the community that are important , but most not to the degree that they desire .


More intervention efforts are needed to increase the sufficiency of community participation .


Reports of long-term tenofovir disoproxil fumarate ( TDF ) treatment in HIV-infected adolescents are limited .


We present final results from the open-label ( OL ) TDF extension following the randomized , placebo ( PBO ) - controlled , double-blind phase of GS-US-@-@ ( Study @ ) .


HIV-infected @ - to @-year-olds treated with TDF @mg or PBO with an optimized background regimen ( OBR ) for @-@ weeks subsequently received OL TDF plus OBR in a single arm study extension .


HIV-@ RNA and safety , including bone mineral density ( BMD ) , was assessed in all TDF recipients .


Eighty-one subjects received TDF ( median duration @ weeks ) .


No subject died or discontinued OL TDF for safety/tolerability .


At week @ , proportions with HIV-@ RNA < @ copies/mL were @ % ( @ of @ subjects with baseline HIV-@ RNA > @ c/mL initially randomized to TDF ) , @ % ( @ of @ subjects with HIV-@ RNA < @ c/mL who switched PBO to TDF ) and @ % ( @ of @ subjects failed randomized PBO plus OBR with HIV-@ RNA > @ c/mL and switched PBO to TDF ) .


Viral resistance to TDF occurred in @ subject .


At week @ , median decrease in estimated glomerular filtration rate was @ mL/min/@ @ m ( n = @ ) .


Increases in median spine ( +@ % , n = @ ) and total body less head BMD ( +@ % , n = @ ) and height-age adjusted Z-scores ( n = @ ; +@ for spine , +@ for total body less head ) were observed at week @ .


Five of @ subjects ( @ % ) had persistent > @ % BMD decreases from baseline .


Some subjects had virologic responses to TDF plus OBR , and TDF resistance was rare .


TDF was well tolerated and can be considered for treatment of HIV-infected adolescents .


To evaluate efficacy , safety , and tolerability of a fixed combination clindamycin phosphate @ % and benzoyl peroxide @ % ( clindamycin-BP @ % ) aqueous gel in moderate to severe acne vulgaris .


A total of @ patients , @-@ years of age , were randomized to receive clindamycin-BP @ % or vehicle in a double-blind , controlled @-week , @-arm study evaluating safety and efficacy using inflammatory and noninflammatory lesion counts , Evaluator Global Severity Scores ( EGSS ) and subject self-assessment ( SSA ) .


In addition , patients completed a patient satisfaction survey ( PSS ) , acne-specific QoL questionnaire , and assessed their facial skin for shininess/oiliness .


Clindamycin-BP @ % demonstrated statistical superiority to vehicle in reducing both inflammatory and noninflammatory lesions and acne severity .


Clindamycin-BP @ % showed greater efficacy relative to vehicle in assessments of skin oiliness , SSA and PSS .


No substantive differences were seen in cutaneous tolerability among treatment groups and no patients discontinued treatment with Clindamycin-BP @ % because of adverse events .


Data from controlled studies may differ from clinical practice .


It is not possible to determine the contributions from the individual active ingredients .


Clindamycin-BP @ % provides statistically significant greater efficacy than vehicle with a favorable safety and tolerability profile .


To determine if the belief that thirdhand smoke is harmful to children is associated with smoking parents ' attitudes , home or car smoking policies , and quitting behaviors .


Data from a national randomized controlled trial , Clinical Effort Against Secondhand Smoke Exposure , assessed thirdhand smoke beliefs of @ smoking parents in an exit survey after a pediatric office visit in @ intervention and @ control practices .


Twelve-month follow-up data were collected from @ parents .


Multivariable logistic regression determined whether belief that thirdhand smoke harms the health of children is independently associated with parental behaviors and attitudes @ months later .


A ( @ ) test assessed whether parents who disagreed that thirdhand smoke is harmful were more likely to make a quit attempt if they later believed that thirdhand smoke is harmful .


Belief at the exit survey that thirdhand smoke is harmful was independently associated with having a strictly enforced smoke-free home policy ( adjusted odds ratio : @ ; @ % CI : @-@ @ ) and car policy ( adjusted odds ratio : @ ; @ % CI : @-@ @ ) at the @-month follow-up .


A significantly higher percentage ( @ % vs @ % ) of parents who did not hold the thirdhand smoke harm belief at baseline made at least @ quit attempt if they agreed that thirdhand smoke is harmful at the @-month follow-up ( P = @ ) .


Thirdhand smoke harm belief was associated with a strictly enforced smoke-free home and car and attempts to quit smoking .


Sensitizing parents to thirdhand smoke risk could facilitate beneficial tobacco control outcomes .


Active video games may offer an effective strategy to increase physical activity in overweight and obese children .


However , the specific effects of active gaming when delivered within the context of a pediatric weight management program are unknown .


To evaluate the effects of active video gaming on physical activity and weight loss in children participating in an evidence-based weight management program delivered in the community .


Group-randomized clinical trial conducted during a @-week period in YMCAs and schools located in Massachusetts , Rhode Island , and Texas .


Seventy-five overweight or obese children ( @ girls -LSB- @ % -RSB- , @ whites -LSB- @ % -RSB- , @ Hispanics -LSB- @ % -RSB- , and @ blacks -LSB- @ % -RSB- ) enrolled in a community-based pediatric weight management program .


Mean ( SD ) age of the participants was @ ( @ ) years ; body mass index ( BMI ) z score , @ ( @ ) ; and percentage overweight from the median BMI for age and sex , @ % ( @ % ) .


All participants received a comprehensive family-based pediatric weight management program ( JOIN for ME ) .


Participants in the program and active gaming group received hardware consisting of a game console and motion capture device and @ active game at their second treatment session and a second game in week @ of the program .


Participants in the program-only group were given the hardware and @ games at the completion of the @-week program .


Objectively measured daily moderate-to-vigorous and vigorous physical activity , percentage overweight , and BMI z score .


Participants in the program and active gaming group exhibited significant increases in moderate-to-vigorous ( mean -LSB- SD -RSB- , @ -LSB- @ -RSB- min/d ) and vigorous ( @ -LSB- @ -RSB- min/d ) physical activity at week @ ( P < @ ) .


In the program-only group , a decline or no change was observed in the moderate-to-vigorous ( mean -LSB- SD -RSB- net difference , @ -LSB- @ -RSB- min/d ; P = @ ) and vigorous ( @ -LSB- @ -RSB- min/d ; P = @ ) physical activity .


Participants in both groups exhibited significant reductions in percentage overweight and BMI z scores at week @ .


However , the program and active gaming group exhibited significantly greater reductions in percentage overweight ( mean -LSB- SD -RSB- , -@ % -LSB- @ % -RSB- vs -@ % -LSB- @ % -RSB- ; P = @ ) and BMI z score ( -@ -LSB- @ -RSB- vs -@ -LSB- @ -RSB- ; P < @ ) .


CONCLUSIONS AND RELEVANCE Incorporating active video gaming into an evidence-based pediatric weight management program has positive effects on physical activity and relative weight .


TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT@ .


To investigate the impact of self-efficacy theory health education in patients of diabetic osteoporosis .


We used SPSS @ software to generate random numbers and @ diabetic osteoporosis patients were randomly divided into an observation group and a control group .


There was @ patients in observation group , @ in control group .


The self-efficacy theory health education was carried out in observation group , and routine health education in control group .


SF-@ questionnaire was used to assess the quality of life .


Osteoporosis self-efficacy scale ( OSES ) was used to assess self-efficacy .


Bone mineral density ( BMD ) was measured by dual energy X-ray absorptiometry .


Blood glucose was detected by glucose oxidase method .


Glycosylated hemoglobin was detected by high efficiency liquid chromatography to estimate the index change before intervention and after one year 's follow up .


The number of patients that had completed follow-up was @ in control group and @ in observation group .


The self-efficacy scores , movement efficiency scores and calcium intake efficiency scores were all higher in intervention group ( ( @ @ ) , ( @ @ ) , ( @ @ ) points ) than which in the control group ( ( @ @ ) , ( @ @ ) , ( @ @ ) points ) after one year 's follow up , there were significant differences in two groups ( t values were @ , @ , @ , all P values < @ ) .


The scores of quality of life in the dimension of general health , vitality , social function , role emotional and mental health were all higher in intervention group ( ( @ @ ) , ( @ @ ) , ( @ @ ) , ( @ @ ) , ( @ @ ) points ) than in the control group ( ( @ @ ) , ( @ @ ) , ( @ @ ) , ( @ @ ) , ( @ @ ) points ) , there were significant differences in two groups ( t values were @ , @ , @ , @ , @ , all P values < @ ) .


Fasting blood-glucose @ hour postprandial blood glucose and glycosylated hemoglobin were all lower in intervention group ( ( @ @ ) mmol/L , ( @ @ ) mmol/L , ( @ @ ) % ) than in the control group ( ( @ @ ) mmol/L , ( @ @ ) mmol/L , ( @ @ ) % ) , there were significant differences in two groups ( t values were @ , @ , @ , all P values < @ ) .


There were @ ( @ % ) fracture case in observation group and @ ( @ % ) cases in control group during one year 's follow up , there are significant difference in two groups ( ( @ ) = @ , P = @ ) .


The self-efficacy theory health education may improve the quality of life and decreased fracture risk of diabetic osteoporosis patients .


Cranial nerve palsy ( CNP ) and neck haematoma are complications of carotid endarterectomy ( CEA ) .


The effects of patient factors and surgical technique were analysed on the risk , and impact on disability , of CNP or haematoma in the surgical arm of the International Carotid Stenting Study ( ICSS ) , a randomized controlled clinical trial of stenting versus CEA in patients with symptomatic carotid stenosis .


A per-protocol analysis of early outcome in patients receiving CEA in ICSS is reported .


Haematoma was defined by the surgeon .


CNP was confirmed by an independent neurologist .


Factors associated with the risk of CNP and haematoma were investigated in a binomial regression analysis .


Of the patients undergoing CEA , @/@ ( @ % ) developed CNP , one of which was disabling ( modified Rankin score = @ at @ month ) .


Twenty-eight ( @ % ) developed severe haematoma .


Twelve patients with haematoma also had CNP , a significant association ( p < @ ) .


Independent risk factors modifying the risk of CNP were cardiac failure ( risk ratio -LSB- RR -RSB- @ , @ % CI @ to @ ) , female sex ( RR @ , @ % CI @ to @ ) , the degree of contralateral carotid stenosis , and time from randomization to treatment > @ days ( RR @ , @ % CI @ to @ ) .


The risk of haematoma was increased in women , by the prescription of anticoagulant drugs pre-procedure and in patients with atrial fibrillation , and was decreased in patients in whom a shunt was used and in those with a higher baseline cholesterol level .


CNP remains relatively common after CEA , but is rarely disabling .


Women should be warned about an increased risk .


Attention to haemostasis might reduce the incidence of CNP .


ICSS is a registered clinical trial : ISRCTN @ .


Vesnarinone Trial ( VesT ) was a three-armed , placebo-controlled , randomized clinical trial designed to study the effects of @ mg or @ mg/day vesnarinone .


Certain contradictory results involving patient health-related quality-of-life ( HRQOL ) and overall survival ( OS ) have made a definitive and unified conclusion difficult .


To reconcile these findings , we have focused on the HRQOL-adjusted OS , commonly known as quality-adjusted life years ( QALYs ) .


Currently , analyses of QALYs incorporate a single HRQOL subscale .


However , the VesT HRQOL instrument had two subscales : physical ( PHYS ) and emotional ( EMOT ) .


We have developed new ways to visualize and compare EMOT - and PHYS-adjusted OS .


In each VesT arm , there was an increased probability of superior EMOT-adjusted OS , compared to PHYS-adjusted OS .


The magnitude of these findings was comparable across trial arms .


Despite inferior survival and superior EMOT and PHYS scores , the @-mg/day arm presents similar EMOT - and PHYS-adjusted OS compared to the placebo arm .


We have provided a fresh perspective on the complex interactions between multiple HRQOL dimensions and OS .


These novel methods address the burgeoning need for robust information on the interplay between OS and HRQOL from a patient , clinical care and public policy perspective .


Hypertension is common in autosomal dominant polycystic kidney disease ( ADPKD ) and is associated with increased total kidney volume , activation of the renin-angiotensin-aldosterone system , and progression of kidney disease .


In this double-blind , placebo-controlled trial , we randomly assigned @ hypertensive participants with ADPKD ( @ to @ years of age , with an estimated glomerular filtration rate -LSB- GFR -RSB- > @ ml per minute per @ m ( @ ) of body-surface area ) to either a standard blood-pressure target ( @/@ to @/@ mm Hg ) or a low blood-pressure target ( @/@ to @/@ mm Hg ) and to either an angiotensin-converting-enzyme inhibitor ( lisinopril ) plus an angiotensin-receptor blocker ( telmisartan ) or lisinopril plus placebo .


The primary outcome was the annual percentage change in the total kidney volume .


The annual percentage increase in total kidney volume was significantly lower in the low-blood-pressure group than in the standard-blood-pressure group ( @ % vs. @ % , P = @ ) , without significant differences between the lisinopril-telmisartan group and the lisinopril-placebo group .


The rate of change in estimated GFR was similar in the two medication groups , with a negative slope difference in the short term in the low-blood-pressure group as compared with the standard-blood-pressure group ( P < @ ) and a marginally positive slope difference in the long term ( P = @ ) .


The left-ventricular-mass index decreased more in the low-blood-pressure group than in the standard-blood-pressure group ( -@ vs. -@ g per square meter per year , P < @ ) ; urinary albumin excretion was reduced by @ % with the low-pressure target and increased by @ % with the standard target ( P < @ ) .


Dizziness and light-headedness were more common in the low-blood-pressure group than in the standard-blood-pressure group ( @ % vs. @ % , P = @ ) .


In early ADPKD , the combination of lisinopril and telmisartan did not significantly alter the rate of increase in total kidney volume .


As compared with standard blood-pressure control , rigorous blood-pressure control was associated with a slower increase in total kidney volume , no overall change in the estimated GFR , a greater decline in the left-ventricular-mass index , and greater reduction in urinary albumin excretion .


( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; HALT-PKD -LSB- Study A -RSB- ClinicalTrials.gov number , NCT@ . )


Laryngoscopy and stimuli inside the trachea cause an intense sympatho-adrenal response .


Remifentanil seems to be the optimal opioid for rigid bronchoscopy due to its potent and short-acting properties .


The purpose of this study was to compare bolus propofol and ketamine as an adjuvant to remifentanil-based total intravenous anesthesia for pediatric rigid bronchoscopy .


Forty children under @ years of age who had been scheduled for a rigid bronchoscopy were included in this study .


After midazolam premedication , a @ g/kg/min remifentanil infusion was started , and patients were randomly allocated to receive either propofol ( Group P ) or ketamine ( Group K ) as well as mivacurium for muscle relaxation .


Anesthesia was maintained with a @ g/kg/min remifentanil infusion and bolus doses of propofol or ketamine .


After the rigid bronchoscopy , @ g/kg/min of remifentanil was maintained until extubation .


Hemodynamic parameters , emergence characteristics , and adverse events were evaluated .


The demographic variables were comparable between the two groups .


The decrease in mean arterial pressure from baseline values to the lowest values during rigid bronchoscopy was greater in Group P ( p = @ ) , while the reduction in the other parameters and the incidence of adverse events were comparable between the two groups .


The need for assisted or controlled mask ventilation after extubation was higher in Group K.


Remifentanil-based total intravenous anesthesia with propofol or ketamine as an adjuvant drug along with controlled ventilation is a viable technique for pediatric rigid bronchoscopy .


Ketamine does not provide a definite advantage over propofol with respect to hemodynamic stability during rigid bronchoscopy , while propofol seems more suitable during the recovery period .


Proton-pump inhibitors ( PPIs ) reduce acid gastroesophageal reflux ( GER ) and esophageal acid exposure in infants ; however , they do not reduce total GER or symptoms attributed to GER .


Reflux is reduced in the left lateral position ( LLP ) .


We hypothesize that the effect of LLP in combination with acid suppression is most effective in reducing GER symptoms in infants .


In this prospective sham-controlled trial , infants ( @-@ months ) with symptoms suggestive of gastroesophageal reflux disease were studied using @-hour pH-impedance , cardiorespiratory and video monitoring , direct nurse observation , and a validated questionnaire .


Infants demonstrating a positive GER symptom association were randomized to @ of @ groups ; PPI + LLP , PPI + head of cot elevation ( HE ) , antacid ( AA ) + LLP , or AA + HE .


HE and AA were considered `` sham '' therapies .


After @ weeks the @-hour studies were repeated on-therapy .


Fifty-one patients were included ( aged @ -LSB- @-@ -RSB- weeks ) .


PPI + LLP was most effective in reducing GER episodes ( @ -LSB- @ -RSB- to @ -LSB- @ -RSB- , P < @ ) and esophageal acid exposure ( median -LSB- interquartile range -RSB- @ % -LSB- @ % -@ % -RSB- to @ % -LSB- @ % -@ % -RSB- , P = @ ) .


No treatment group showed improvement in crying/irritability , although vomiting was reduced in AA + LLP ( from @ -LSB- @ -RSB- to @ -LSB- @ -RSB- episodes P = @ ) .


LLP compared with HE produced greater reduction in total GER ( -@ -LSB- @ -RSB- vs -@ -LSB- @ -RSB- , P = @ ) , regardless of acid-suppressive therapy .


Acid exposure was reduced on PPI compared with AA ( -@ -LSB- @ -RSB- vs -@ -LSB- @ -RSB- % , pH < @ , P = @ ) regardless of positional intervention .


A post-hoc analysis using automated analysis software revealed a significant reduction in crying symptoms in the PPI + LLP group ( @ -LSB- @-@ -RSB- to @ -LSB- @-@ -RSB- episodes , P = @ ) .


`` Symptomatic gastroesophageal reflux disease '' implies disease causation for distressing infant symptoms .


In infants with symptoms attributed to GER , LLP produced a significant reduction in total GER , but did not result in a significant improvement in symptoms other than vomiting ; however , automated analysis appeared to identify infants with GER-associated crying symptoms who responded to positioning therapy .


This is an important new insight for future research .


A bivalent killed whole cell oral cholera vaccine has been found to be safe and efficacious for five years in the cholera endemic setting of Kolkata , India , when given in a two dose schedule , two weeks apart .


A randomized controlled trial revealed that the immune response was not significantly increased following the second dose compared to that after the first dose .


We aimed to evaluate the impact of an extended four week dosing schedule on vibriocidal response .


In this double blind randomized controlled non-inferiority trial , @ Indian , non-pregnant residents aged @ year or older were randomized to receive two doses of oral cholera vaccine at @ and @ day intervals .


We compared vibriocidal immune responses between these schedules .


Among adults , no significant differences were noted when comparing the rates of seroconversion for V. cholerae O@ Inaba following two dose regimens administered at a @ day interval ( @ % ) vs the @ day interval ( @ % ) .


Similarly , no differences in seroconversion were demonstrated in children comparing the @ ( @ % ) and @ day intervals ( @ % ) .


Following @ and @ day dosing intervals , vibriocidal response rates against V. cholerae O@ Ogawa were @ % and @ % in adults and @ % and @ % in children respectively .


Responses were lower for V. cholerae O@ , but similar between dosing schedules for adults ( @ % , @ % ) and children ( @ % , @ % ) .


Comparable immune responses and safety profiles between the two dosing schedules support the option for increased flexibility of current OCV dosing .


Further operational research using a longer dosing regimen will provide answers to improve implementation and delivery of cholera vaccination in endemic and epidemic outbreak scenarios .


The association between testosterone deficiency and insulin resistance in men with type @ diabetes is well established and current endocrine society guidelines recommend the measurement of testosterone levels in all men with type @ diabetes or erectile dysfunction .


We report the first double-blind , placebo-controlled study conducted exclusively in a male type @ diabetes population to assess metabolic changes with long-acting testosterone undecanoate ( TU ) .


The type @ diabetes registers of seven general practices identified @ patients for a @-week double-blind , placebo-controlled study of long-acting TU @,@ mg followed by @ weeks of open-label use .


Because of the established impact of age , obesity , and depression on sexual function , these variables were also assessed for influence on metabolic parameters .


Changes in glycated hemoglobin ( HbA@c ) and the level of testosterone at which response are achieved .


Treatment with TU produced a statistically significant reduction in HbA@c at @ and @ weeks and after a further @ weeks of open-label medication most marked in poorly controlled patients with baseline HbA@c greater than @ where the reduction was @ % within @ weeks , and a further @ % after @ weeks of open-label use .


There was significant reduction in waist circumference , weight , and body mass index in men without depression , and improvements were related to achieving adequate serum levels of testosterone .


There were no significant safety issues .


Testosterone replacement therapy significantly improved HbA@c , total cholesterol , and waist circumference in men with type @ diabetes .


Improvements were less marked in men with depression at baseline , and therapeutic responses were related to achieving adequate serum testosterone levels .


Current advice on @ - to @-month trials of therapy may be insufficient to achieve maximal response .


Patients reported significant improvements in general health .


This randomized trial evaluated the feasibility and safety of thulium @-nm laser to perform anatomic lung resections in patients with incomplete fissures , as compared to mechanical staplers with or without sealants .


Seventy-two patients scheduled for segmentectomy or lobectomy were enrolled .


After intraoperative confirmation of the extent of resection and incomplete fissures ( Craig type @ , @ or @ ) , they were randomized and allocated to one of the following arms : laser resection by thulium ( group A ) or standard resection with mechanical staplers with or without sealants ( group B ) .


The primary endpoints of the study included analysis of intraoperative and postoperative course , and costs .


Thirty-eight patients were assigned to group A ( @ lobectomies , @ segmentectomies ) and @ to group B ( @ lobectomies , @ segmentectomies ) .


No @-day mortality was observed .


Median operative times were @ minutes ( group A ) and @ minutes ( group B , P = @ ) .


The median time to drainage removal was @ days ( group A ) and @ days ( group B ) , while the median length of hospital stay was the same ( @ days ) .


Prolonged air leaks > @ days were observed in @ patients of group A ( @ % ) and @ patients of group B ( @ % , P = @ ) .


Unpredictable late pneumothorax occurred in @ patients of group A ( @ readmissions , need for @ repeat thoracotomy ) .


Cost analysis demonstrated an intraoperative advantage for group A ( mean @ @ euro ) versus group B ( mean @,@ + / -@ euro , P < @ ) , but the differences in total costs could be due to chance ( P = @ ) .


The use of laser to complete fissures can lead to late pneumothorax , even in the absence of postoperative air leaks .


Moreover , the use of laser to complete fissures did not prove to reduce overall costs .


Trial Registration Identification Number : @/@ ( IRB@ - FWA@ - IORG@ ) .


Childhood obesity is a major public health concern worldwide while the current epidemic may be secondary to over consumption of high-fat , energy-rich foods .


Purslane ( Portulaca oleracea L. ) has been traditionally used in medicine for several antioxidant and anti-atherogenic activities .


In this study the anti-dyslipidemic effects of Poleracea was evaluated in obese adolescents .


In this triple-blinded randomized placebo-controlled clinical trial which was done from July @ to June @ , obese adolescent patients whom were referred to the Isfahan Cardiovascular Research Institute ( Iran ) were randomly allocated to the two arms of cases and controls .


The cases group was asked to take one capsule containing powdered P. oleracea seeds ( @ milligrams ) two times a day for one month , and the controls group were asked to take identical but placebo ( lactose ) capsules in the same way .


Biochemical parameters including @-hours fasting serum levels of total cholesterol , low-density lipoprotein cholesterol ( LDL-C ) , high-density lipoprotein cholesterol ( HDL-C ) , and triglycerides ( TG ) were measured before the initiation and after the completion of the study protocol .


Total cholesterol , LDL-C , and TG showed statistically significant changes over time ( one month ) in the P. oleracea group ( p < @ ) .


However , between-group analysis using general linear model ( multivariate ) test revealed that the differences in the mentioned parameters between two study groups were statistically significant just for LDL-C and TG , while others did not differ significantly .


P. oleracea L. may have positive effects on serum lipids profile which may be attributed to its polyphenolic and antioxidant compounds .


This herbal drug seems to be well-tolerated in adolescent population as well .


Further studies are recommended .


To examine whether optimism/pessimism reliably predicts depression and whether such function is stable also in older age .


In a prospective study , we observed a representative sample of n = @,@ primary care patients over @ years .


The Life Orientation Test ( LOT-R , measuring optimism/pessimism ) and the Depression-Screening Questionnaire were applied .


Medical diagnoses were recorded by the treating physician in a structured medical interview .


Depression could only be predicted by LOT-R scores in younger-age cohorts .


In older adults , test stability and predictive accuracy of optimism/pessimism were markedly reduced , while somatic comorbidity gained importance as a predictor .


Predictive value of screening measures for mental disorders may be specific in older age due to lower trait stability and age-specific psychometric limitations as well as age-related changes in relevant predictors .


To compare the effects of vildagliptin with those of glimepiride on glycaemic control , fat tolerance and inflammatory markers in people with Type @ diabetes mellitus receiving metformin treatment .


A total of @ participants were randomized to vildagliptin @mg twice a day or glimepiride @mg three times a day , for @months .


We evaluated the following variables : BMI ; glycaemic control ; fasting plasma insulin ; homeostatic model assessment of insulin resistance index ; fasting plasma proinsulin ; glucagon ; lipid profile ; adiponectin ; high-sensitivity C-reactive protein ; interleukin-@ ; and tumour necrosis factor - .


A euglycaemic-hyperinsulinaemic clamp procedure and an oral fat load test were also performed .


Despite a similar decrease in HbA@c levels ( P = @ , and P = @ , respectively ) , body weight increased with glimepiride ( P = @ vs baseline ) and decreased with vildagliptin ( P = @ vs baseline and vs glimepiride ) .


Fasting plasma insulin and homeostatic model assessment of insulin resistance index were significantly lower with vildagliptin compared with glimepiride ( P = @ and @ ) .


M value , an index of insulin sensitivity , increased with vildagliptin , both compared with baseline and with glimepiride ( P = @ and @ , respectively ) .


Vildagliptin improved all post-oral fat load peaks of lipid profile compared with glimepiride .


Adiponectin levels were higher ( P = @ ) and high-sensitivity C-reactive protein levels were lower ( P = @ ) with vildagliptin vs glimepiride .


During the oral fat load test , interleukin-@ , high-sensitivity C-reactive protein and tumour necrosis factor - peaks were lower and adiponectin peak was higher in the vildagliptin group than in the glimepiride group .


There was a higher dropout rate as a result of hypoglycaemia in the glimepiride group than in the vildagliptin group .


Vildagliptin was more effective than glimepiride in reducing post-oral fat load peaks of lipid-trafficking adipocytokines and inflammatory markers .


Congenital cytomegalovirus ( CMV ) is the most common congenital infection in the U.S. and can result in permanent disabilities , such as hearing and vision loss , intellectual disability , and psychomotor and language impairments .


Women can adopt prevention behaviors in an attempt to reduce their exposure to CMV .


Currently , few women are familiar with CMV .


To increase awareness of CMV , the Centers for Disease Control and Prevention ( CDC ) developed draft health education materials .


The purpose of this study was to pilot test two health education materials to gauge their appeal and to determine if they increase knowledge about CMV and motivate audiences to seek additional information on CMV and adopt CMV prevention behaviors .


African-American ( n = @ ) and Caucasian women ( n = @ ) , who had a young child and were either pregnant or planning a pregnancy , were recruited to participate in a @-minute web survey .


Participants were randomly assigned to view one of two CMV health education materials , either a factsheet or video .


Pre and post survey measures were used to assess changes in knowledge of CMV and motivation to adopt prevention behaviors .


We also examined audience preferences regarding materials and motivation .


CMV knowledge score increased significantly after presentation of either the video or factsheet ( from @ out of @ to @ out of @ , p < @ ) .


The average materials appeal score was high , with a mean of @ on a four-point scale , indicating women responded very positively to both materials .


Regression analyses indicated that appeal , message involvement ( e.g. , information seeking , discussing with others ) , post materials knowledge score , and viewing the video ( vs. factsheet ) were significantly positively associated with increased support for CMV prevention behaviors .


Overall , we found that the health education materials improved women 's knowledge of CMV and encouraged them to adopt prevention behaviors .


Given the low awareness levels among women currently , these findings suggest that appropriate education materials have the potential to greatly increase knowledge of CMV .


As women become more knowledgeable about CMV and transmission routes , we expect they will be more likely to adopt prevention behaviors , thereby reducing their risk of CMV infection .


Prospective studies have shown an inverse relationship between whole grain consumption and the risk of type @ diabetes , where short chain fatty acids ( SCFA ) may be involved .


Our objective was to determine the effect of isolated arabinoxylan alone or in combination with whole grain rye kernels on postprandial glucose , insulin , free fatty acids ( FFA ) , gut hormones , SCFA and appetite in subjects with the metabolic syndrome ( MetS ) .


Fifteen subjects with MetS participated in this acute , randomised , cross-over study .


The test meals each providing @g of digestible carbohydrate were as follows : semolina porridge added concentrated arabinoxylan ( AX ) , rye kernels ( RK ) or concentrated arabinoxylan combined with rye kernels ( AXRK ) and semolina porridge as control ( SE ) .


A standard lunch was served @h after the test meals .


Blood samples were drawn during a @-h period , and appetite scores and breath hydrogen were assessed every @min .


The AXRK meal reduced the acute glucose ( P = @ ) and insulin responses ( P < @ ) and the feeling of hunger ( P = @ ; @-@min ) compared with the control meal .


The AX and AXRK meals increased butyrate and acetate concentrations after @h .


No significant differences were found for the second meal responses of glucose , insulin , FFA , glucagon-like peptide-@ or ghrelin .


Our results indicate a stimulatory effect of arabinoxylan on butyrate and acetate production , however , with no detectable effect on the second meal glucose response .


It remains to be tested in a long-term study if a beneficial effect on the glucose response of the isolated arabinoxylan will be related to the SCFA production .


Fibre-rich rye products have been shown to have superior effects on self-reported appetite compared to white wheat bread and some studies have shown lower energy intake after subsequent meal .


The aim of the present study was to evaluate the effects of whole grain rye crisp bread ( RB ) versus refined wheat bread ( WB ) on appetite in two studies using different portion sizes and total energy intakes .


Two randomised cross-over pre-load studies were conducted in @ and @ subjects , respectively .


Appetite was rated by visual analogue scale ( VAS ) for @ h.


In both studies , participants were @ @ years old and had BMI @ @ .


The studies differed in terms of energy content of the breakfasts and proportion of energy from the treatment product as well as amount of test products .


Differences between treatments within the two studies were evaluated using mixed models with repeated measures appropriate for cross-over designs .


In Study one , hunger and desire to eat were significantly lower ( P < @ ) after RB compared with WB , but there were no difference for fullness or difference in energy intake at lunch served ad libitum .


In Study two , the portion size was lower than in Study one and the test product constituted a larger proportion of the breakfast .


Fullness was significantly higher after RB compared with WB ( P < @ ) and hunger , desire to eat as well as energy intake at lunch were significantly lower ( P < @ ) .


Whole grain rye crisp bread caused lower self-reported hunger , higher fullness and less desire to eat compared to refined wheat bread .


It also led to a lower energy intake after an ad libitum lunch .


Results were stronger and/or more consistent when the test meal portion was smaller and accounted for a larger proportion of the total energy intake of the breakfast .


To determine the occurrence of extremely low HDL cholesterol ( HDL-C ) among participants in the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) Lipid Trial and to examine the relationship of this finding with treatment with fenofibrate and thiazolidinedione ( TZD ) .


The ACCORD Lipid Trial was a randomized , double-blind , placebo-controlled study conducted in patients with type @ diabetes at @ clinical centers across the U.S. and Canada in a @,@-patient subset of the larger @,@ ACCORD Glycemia Trial .


Patients were enrolled from @ January @ to @ October @ and followed until the end of study visits between @ March and @ June @ .


Follow-up in the ACCORD Lipid Trial was @-@ years ( mean @ years ) .


Patients were treated with blinded fenofibrate or placebo on a background of simvastatin therapy .


The main outcome measures for these descriptive , post hoc analyses was the occurrence of extremely low HDL-C ( defined as < @ mg/dL -LSB- @ mmol/L -RSB- ) during the trial .


Among ACCORD Lipid Trial participants , the occurrence of extremely low HDL-C ever during study follow-up was @ % higher among those randomized to fenofibrate ( @ % fenofibrate vs. @ % placebo , P < @ ) .


The occurrence of low HDL-C was associated with concurrent treatment with fenofibrate and TZD ( @ % for both vs. @ % for neither at @ months postrandomization ) .


Idiosyncratic and marked reduction in HDL-C can occur in some patients treated with both fenofibrate and TZD .


Practitioners should recognize this important potential idiosyncratic reaction and take appropriate corrective action .


Osteoarthritis affecting the first metatarsophalangeal joint of the foot is a common condition which results in pain , stiffness and impaired ambulation .


Footwear modifications and foot orthoses are widely used in clinical practice to treat this condition , but their effectiveness has not been rigorously evaluated .


This article describes the design of a randomised trial comparing the effectiveness of rocker-sole footwear and individualised prefabricated foot orthoses in reducing pain associated with first metatarsophalangeal joint osteoarthritis .


Eighty people with first metatarsophalangeal joint osteoarthritis will be randomly allocated to receive either a pair of rocker-sole shoes ( MBT Matwa , Masai Barefoot Technology , Switzerland ) or a pair of individualised , prefabricated foot orthoses ( Vasyli Customs , Vasyli Medical , Queensland , Australia ) .


At baseline , the biomechanical effects of the interventions will be examined using a wireless wearable sensor motion analysis system ( LEGSys , BioSensics , Boston , MA , USA ) and an in-shoe plantar pressure system ( Pedar , Novel GmbH , Munich , Germany ) .


The primary outcome measure will be the pain subscale of the Foot Health Status Questionnaire ( FHSQ ) , measured at baseline and @ , @ and @ weeks .


Secondary outcome measures will include the function , footwear and general foot health subscales of the FHSQ , severity of pain and stiffness at the first metatarsophalangeal joint ( measured using @ mm visual analog scales ) , global change in symptoms ( using a @-point Likert scale ) , health status ( using the Short-Form-@ Version @ questionnaire ) , use of rescue medication and co-interventions to relieve pain , the frequency and type of self-reported adverse events and physical activity levels ( using the Incidental and Planned Activity Questionnaire ) .


Data will be analysed using the intention to treat principle .


This study is the first randomised trial to compare the effectiveness of rocker-sole footwear and individualised prefabricated foot orthoses in reducing pain associated with osteoarthritis of the first metatarsophalangeal joint , and only the third randomised trial ever conducted for this condition .


The study has been pragmatically designed to ensure that the findings can be implemented into clinical practice if the interventions are found to be effective , and the baseline biomechanical analysis will provide useful insights into their mechanism of action .


To analyze the impact of a home exercise training ( ET ) program on quality of life , motor activity ( MA ) , dietary habit , functional and biochemical parameters , and clinical course of the disease in patients who have experienced acute coronary syndrome ( ACS ) and/or endovascular coronary intervention ( ECI ) .


The trial included @ patients after ECL who were randomized into @ groups : those who had gone through Patient School ( PS ) and received a @-week course of controlled ET ( a study group ( Group S ) ) and those who had gone through PS only ( a control group ( Group C ) .


The patients of both groups were recommended a home ET program and , according to its implementation , they formed @ subgroups : Subgroup A ( home ET + ) comprising @ patients who had trained themselves at home ) and Subgroup B ( home ET - ) consisting of @ patients who had not .


The follow-up lasted @ year .


Quality of life , risk factors , lifestyle and clinical parameters were assessed .


As time elapsed , the patients ' motivation to perform home ET ; and , accordingly , the proportion of those who had trained themselves decreased in Group S to @ and @ % and in Group C to @ and @ % after @ and @ months , respectively .


Among the reasons for refusal to perform home ET , disease was reported by only @ % of the patients ( by all from Group C ) .


The comprehensive physical rehabilitation program ( RP ) ( controlled ET in combination with home ET ) produced the best effect in raising the level of daily MA , exercise performance with a @-fold increase in cardiac performance ( p < @ ) and a @-fold decrease in heart rate increment in response to exercises .


Group C patients who had refused the home ET program , as compared to those in the same group who had trained themselves at home , showed the worst daily MA levels , none body mass index reduction , and a rise in the low-density lipoprotein cholesterol ( by @ % ; p < @ ) and in the number of angina attacks ( by @ times ; p < @ ) .


RP in the early-stage , which encompasses an educational program ( PS ) , a short-term course of controlled ET and home ET used in patients with ACS , including in those after ECI , has clear clinical benefits .


The participation of patients with coronary heart disease ( CHD ) in the home ET programs increases their motivation and , hence , the proportion of those who participate in therapeutic and rehabilitation measures .


Home patient physical rehabilitation is one of the important components of different rehabilitation and prevention programs in patients with CHD after ACS and ECI .


Budesonide is a high-potency , second-generation corticosteroid designed to minimize systemic adverse consequences of conventional corticosteroids .


We performed @ randomized , phase @ trials to evaluate the ability of budesonide rectal foam , formulated to optimize retention and provide uniform delivery of budesonide to the rectum and distal colon , to induce remission in patients with ulcerative proctitis or ulcerative proctosigmoiditis .


Two identically designed , randomized , double-blind , placebo-controlled trials evaluated the efficacy of budesonide foam for induction of remission in @ patients with mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis who received budesonide foam @ mg/@ mL twice daily for @ weeks , then once daily for @ weeks , or placebo .


Remission at week @ occurred significantly more frequently among patients receiving budesonide foam than placebo ( Study @ : @ % vs @ % ; P = @ ; Study @ : @ % vs @ % ; P < @ ) .


A significantly greater percentage of patients receiving budesonide foam vs placebo achieved rectal bleeding resolution ( Study @ : @ % vs @ % ; P = @ ; Study @ : @ % vs @ % ; P = @ ) and endoscopic improvement ( Study @ : @ % vs @ % ; P = @ ; Study @ : @ % vs @ % ; P = @ ) at week @ .


Most adverse events occurred at similar frequencies between groups , although events related to changes in cortisol values were reported more frequently with budesonide foam .


There were no cases of clinically symptomatic adrenal insufficiency .


Budesonide rectal foam was well tolerated and more efficacious than placebo in inducing remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis .


ClinicalTrials.gov ID : NCT@ and NCT@ .


Flexible cystoscopy is a common practice in urology .


We wanted to determine whether a retention time of @ minutes between the administration of a local anesthetic lubricant and flexible cystoscope insertion decreased the degree of discomfort or pain in the patient .


Males who underwent flexible cystoscopy during @ months were randomized in a prospective study .


They were divided into two groups .


In the first one , the Cathejell lubricant with lidocaine @ g was administered and cystoscopy was performed immediately .


In the second one , the same lubricant was maintained in the urethra for @ minutes before the performance of cystoscopy .


After scanning , all the patients were requested to indicate the degree of perceived pain on a visual pain scale from @ to @ , with @ being no discomfort and @ being the maximum degree of pain bearable .


As a secondary objective , the relationship of pain to age and to the type of cystoscopist ( urologist/resident doctor ) was studied .


For statistical analysis , a Student 's t-test for independent samples and correlation analysis were used .


A total of @ patients were studied , @ in the immediate group and @ in the @-minute delay group , with samples being homogeneous for the age and type of cystoscopist .


The mean in the pain scale in the immediate group was @ , and in the @-minute delay group was @ , with no significant differences between them ( p = @ ) .


There was no relationship with age ( r = -@ , p = @ ) or with the type of cystoscopist ( @ of average pain in the associate group , @ in the resident , p = @ ) .


There is no benefit in waiting a short time after the administration of intraurethral lubrication with a local anesthetic in flexible cystoscopy in men .


There is also no relationship between the patient age or the type of cystoscopist ( urologist/resident doctor ) and perceived pain .


Bariatric patients seeking information meet very different recommendations on postoperative diet and eating behaviour .


A reason for variability may be lack of hard evidence .


A national survey on current dietary advice was conducted to serve as background for the present study on how drinking during a meal influenced caloric consumption .


A standardised questionnaire was sent to all units in the Scandinavian Obesity surgery registry ( SOReg ) in order to obtain information regarding current diet advice after gastric bypass .


Twenty-eight patients , @ in each group , were studied either @ months or @ year after a standard gastric bypass ( GBP ) .


A standardised lunch was served on two separate days with or without water in randomised order .


Meal and water weights were measured before and after .


Hunger/satiety scores were obtained using visual analogue scales .


Response rate for surgeons was low , for dieticians @ % .


No clear consensus for liquid intake during meals was found ; few surgeons advised patients whether or not to drink with meals .


All patients ate to full satiety .


Two months post-GBP , @/@ patients consumed more solid food when allowed drinking water ; the increase in caloric consumption was not significant .


One year post-GBP , @/@ patients consumed more solid food when allowed drinking water , the difference not reaching statistical significance .


Our study does not indicate that patients should refrain from drinking during meals the first year after a GBP , at least not from a caloric intake point of view .


Ultrasound-guided nerve blocks ( UGNB ) are increasingly used in emergency care .


The hand-on-syringe ( HS ) needle technique is ideally suited to the emergency department setting because it allows a single operator to perform the block without assistance .


The HS technique is assumed to provide less exact needle control than the alternative two-operator hand-on-needle ( HN ) technique ; however this assumption has never been directly tested .


The primary objective of this study was to compare accuracy of needle targeting under ultrasound guidance by emergency medicine ( EM ) residents using HN and HS techniques on a standardized gelatinous simulation model .


This prospective , randomized study evaluated task performance .


We compared needle targeting accuracy using the HN and HS techniques .


Each participant performed a set of structured needling maneuvers ( both simple and difficult ) on a standardized partial-task simulator .


We evaluated time to task completion , needle visualization during advancement , and accuracy of needle tip at targeting .


Resident technique preference was assessed using a post-task survey .


We evaluated @ tasks performed by @ EM residents .


There was no significant difference in time to complete the simple model ( HN vs. HS , @ seconds vs. @ seconds , p = @ ) , time to complete the difficult model ( HN vs. HS , @ seconds vs. @ seconds , p = @ ) , needle visualization , or needle tip targeting accuracy .


Most residents ( @ % ) preferred the HS technique .


For EM residents learning UGNBs , the HN technique was not associated with superior needle control .


Our results suggest that the single-operator HS technique provides equivalent needle control when compared to the two-operator HN technique .


For women at risk of HIV-@ , effective contraception and effective HIV-@ prevention are global priorities .


In a clinical trial of pre-exposure prophylaxis ( PrEP ) for HIV-@ prevention in HIV-@-serodiscordant couples , we estimated the effectiveness of hormonal contraceptives ( oral contraceptive pills , injectable depot medroxyprogesterone acetate , and hormonal implants ) for pregnancy prevention relative to no contraception among @ HIV-@-uninfected women followed up to @ months .


We compared the effectiveness of each method among women assigned PrEP versus placebo .


Contraception was not required for participation , but was offered on-site and was recorded monthly ; incident pregnancy was determined by monthly urine testing .


For women using no contraception , overall pregnancy incidence was @ % per year .


Women reporting oral contraceptive use had comparable pregnancy incidence to women using no contraception , and this lack of contraceptive effectiveness was similar for those assigned PrEP and placebo ( @ and @ % incidence per year , respectively ; P-value for difference in effect by PrEP use = @ ) .


Women reporting injectable contraception had reduced pregnancy incidence compared to those reporting no contraception , which did not differ by arm ( PrEP @ % , placebo @ % per year ; P-value for difference = @ ) .


Contraceptive effectiveness was highest among women using implants ( pregnancy incidence < @ % per year in both arms ) .


PrEP had no adverse impact on hormonal contraceptive effectiveness for pregnancy prevention .


As seen previously in similar populations , women reporting contraceptive pill use had little protection from pregnancy , possibly due to poor adherence .


Injectable or implantable hormonal contraception and PrEP provide effective prevention for pregnancy and HIV-@ .


To investigate acute hypervolemic hemodilution effect on oxygen metabolism and blood pharmacokinetics in patients undergoing acute laparotomy during Induction of general anesthesia .


Forty ASA I-II patients undergoing acute laparotomy were randomly divided into @ groups ( n = @ each ) : Patients of group A received Voluven @ ml/kg in @ mins before induction and @ ml/kg after induction .


Patients of group B received @ ml/kg/h Plasmalyte A. Hemodynamic parameters MAP , HR and CVP were collected at @ set points during the surgery : T@ : before AHH ; T@ : before anesthesia induction ; T@ : right intubation ; T@ : @ min after intubation ; T@ : @ min after intubation ; T@ : skin incision .


Arterial and venous blood samples were taken for blood gas analysis and determination of lactic acid , Hb and Hct : T@ : before AHH , T@ : right after AHH , T@ : @ h after AHH , T@ : l h after AHH .


Arterial Oxygen Content ( Ca@ ) , Central Venous Oxygen Content ( Ccv@ ) and Oxygen Extraction Ratio ( ER@ ) were calculated .


The hemodynamic parameters were maintained within normal limits during operation in group A ( P < @ ) .


CaO@ , CcvO@ , ERO@ and Lac between the two groups were no significant difference ( P > @ ) .


Compared with T@ , CaO@/CcvO@ atT @ ~ @ reduced in both groups ( P < @ ) .


Compared with group A , Hb and Hct in group B increased at T@ ~ @ ( P < @ ) .


Acute hypervolemic hemodilution in patients undergoing acute laparotomy during Induction of general anesthesia have some preventive hypotension effect , more conducive to the smooth blood pharmacokinetics ; Voluven induced expansion of applications is safe and effective , and has no effect on the body 's metabolic rate of oxygen .


To compare in a randomized controlled clinical trial ( RCT ) the application of the TheraBite ( TB ) Jaw Motion Rehabilitation System with a standard physical therapy ( PT ) exercise regimen for the treatment of myogenic temporomandibular disorder ( TMD ) .


Myogenic TMD patients were randomized for the use of the TB device or for standard PT .


Mandibular function was assessed with the mandibular function impairment questionnaire ( MFIQ ) .


Pain was evaluated using a visual analog scale , and maximum inter-incisor ( mouth ) opening ( MIO ) was measured using the disposable TB range of motion scale .


Of the @ patients randomized ( @ TB , @ standard PT exercises ) , @ actually started with the TB device and @ with the standard PT exercises .


After six-week follow-up , patients using the TB device reported a significantly greater functional improvement ( MFIQ score ) than the patients receiving regular PT exercises ( P = @ ) .


At @ weeks , no significant differences in pain , and active or passive MIO were found between the two groups .


At @ months , patients in both treatment groups did equally well , and showed a significant improvement in all parameters assessed .


This RCT on myogenic TMD treatment , comparing standard PT with passive jaw mobilization using the TheraBite Jaw Motion Rehabilitation System , shows that both treatment modalities are equally effective in relieving myogenic TMD symptoms , but that the use of the TB device has the benefit of achieving a significantly greater functional improvement within the first week of treatment .


Efforts are needed to improve informed consent of participants in research .


The Strategic Timing of AntiRetroviral Therapy ( START ) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants .


Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site 's participants .


A total of @ HIV-positive participants at @ sites world-wide took part in the Informed Consent Substudy , with consent given in @ primary languages .


Most sites sent written information to potential participants in advance of clinic visits , usually including the consent form .


At about half the sites , staff reported spending less than an hour per participant in the consent process .


The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment .


These data reflect the interest of START research staff in evaluating the consent process and improving informed consent .


The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted .


Its results have the potential to impact how consent forms are written around the world .


To evaluate the effect of different methods to convert magnetic resonance ( MR ) signal intensity ( SI ) to gadolinium concentration ( -LSB- Gd -RSB- ) on estimation and reproducibility of model-free and modeled hepatic perfusion parameters measured with dynamic contrast-enhanced ( DCE ) - MRI .


In this Institutional Review Board ( IRB ) - approved prospective study , @ DCE-MRI examinations of the liver were performed on @ patients .


SI was converted to -LSB- Gd -RSB- using linearity vs. nonlinearity assumptions ( using spoiled gradient recalled echo -LSB- SPGR -RSB- signal equations ) .


The -LSB- Gd -RSB- vs. time curves were analyzed using model-free parameters and a dual-input single compartment model .


Perfusion parameters obtained with the two conversion methods were compared using paired Wilcoxon test .


Test-retest and interobserver reproducibility of perfusion parameters were assessed in six patients .


There were significant differences between the two conversion methods for the following parameters : AUC@ ( area under the curve at @ s , P < @ ) , peak gadolinium concentration ( Cpeak , P < @ ) , upslope ( P < @ ) , Fp ( portal flow , P = @ ) , total hepatic flow ( Ft , P = @ ) , and MTT ( mean transit time , P < @ ) .


Our preliminary results showed acceptable to good reproducibility for all model-free parameters for both methods ( mean coefficient of variation -LSB- CV -RSB- range , @-@ @ % ) , except for upslope ( CV = @ % ) .


Among modeled parameters , DV ( distribution volume ) had CV < @ % with both methods , PV and MTT showed CV < @ % and < @ % using SPGR equations , respectively .


Other modeled parameters had CV > @ % with both methods .


Linearity assumption is acceptable for quantification of model-free hepatic perfusion parameters while the use of SPGR equations and T@ mapping may be recommended for the quantification of modeled hepatic perfusion parameters .


The effectiveness of two treatment approaches ( phonological therapy and articulation therapy ) for treatment of @ children , aged @ ; @-@ ; @ years , with phonologically based speech-sound disorder ( SSD ) has been previously analysed with severity outcome measures ( percentage of consonants correct score , percentage occurrence of phonological processes and phonetic inventory ) .


Considering that the ultimate goal of intervention for children with phonologically based SSD is to improve intelligibility , it is curious that intervention studies focusing on children 's phonology do not routinely use intelligibility as an outcome measure .


It is therefore important that the impact of interventions on speech intelligibility is explored .


This paper investigates the effectiveness of the two treatment approaches ( phonological therapy and articulation therapy ) using intelligibility measures , both in single words and in continuous speech , as the primary outcome .


Fourteen children with phonologically based SSD participated in the intervention .


The children were randomly assigned to phonological therapy or articulation therapy ( seven children in each group ) .


Two assessment methods were used for measuring intelligibility : a word identification task ( for single words ) and a rating scale ( for continuous speech ) .


Twenty-one unfamiliar adults listened and judged the children 's intelligibility .


Reliability analyses showed overall high agreement between listeners across both methods .


Significant improvements were noted in intelligibility in both single words ( paired t ( @ ) = @ , p = @ ) and continuous speech ( asymptotic Z = @ , p = @ ) for the group receiving phonology therapy pre - to post-treatment , but no differences in intelligibility were found for those receiving the articulation therapy pre - to post-treatment , either for single words ( paired t ( @ ) = @ , p = @ ) or continuous speech ( asymptotic Z = @ , p = @ ) .


Intelligibility measures were sensitive enough to show changes in the phonological therapy group but not in the articulation therapy group .


These findings emphasize the importance of using intelligibility as an outcome measure to complement the results obtained with other severity measures when exploring the effectiveness of speech interventions .


This study presents new evidence for the effectiveness of phonological therapy in improving intelligibility with children with SSD .


Staphylococcus aureus bacteremia is a common infection associated with significant morbidity and mortality .


Telavancin is a bactericidal lipoglycopeptide active against Gram-positive pathogens , including methicillin-resistant S. aureus ( MRSA ) .


We conducted a randomized , double-blind , Phase @ trial in patients with uncomplicated S. aureus bacteremia .


Patients were randomized to either telavancin or standard therapy ( vancomycin or anti-staphylococcal penicillin ) for @days .


Continuation criteria were set to avoid complicated S. aureus bacteremia .


The primary end point was clinical cure at @days .


In total , @ patients were randomized and @ received @ study medication dose ( all-treated ) , @ patients fulfilled inclusion/exclusion and continuation criteria ( all-treated target -LSB- ATT -RSB- ) ( telavancin @ , standard therapy @ ) , and @ patients were clinically evaluable ( CE ) ( telavancin @ , standard therapy @ ) .


Mean age ( ATT ) was @years .


Intravenous catheters were the most common source of S. aureus bacteremia and ~ @ % of patients had MRSA .


A similar proportion of CE patients were cured in the telavancin ( @ % ) and standard therapy ( @ % ) groups .


All patients with MRSA bacteremia were cured and one patient with MSSA bacteremia failed study treatment in each group .


Although adverse events ( AEs ) were more common in the telavancin ATT group ( @ % vs. @ % ) , AEs leading to drug discontinuation were similar ( @ % ) in both treatment arms .


Potentially clinically significant increases in serum creatinine ( @ mg/dl and at least @ % greater than baseline ) were more common in the telavancin group ( @ % vs. @ % ) .


This study suggests that telavancin may have utility for treatment of uncomplicated S. aureus bacteremia ; additional studies are warranted .


( Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia ( ASSURE ) ; NCT@ ) .


To evaluate the effectiveness of sulodexide for the treatment of hard exudates ( HE ) in non-proliferative diabetic retinopathy ( NPDR ) .


This was a randomized , placebo-controlled , multicenter trial involving @ patients ( @ for each group ) who had mild-to-moderate NPDR with macular HE .


Participants were given a daily dose of either @ mg sulodexide or a matching dose of placebo orally for @ months .


Main outcome measure was an improvement in HE defined as a decrease in severity by at least two grades on a @-grade severity scale .


This was evaluated by fundus photography over @-month period .


The sulodexide group showed significantly greater improvement in HE severity than that shown by the placebo group ( @ % vs. @ % ; chi square , P = @ ) .


Logistic regression analysis yielded an odds ratio of @ ( @ % confidence interval , @-@ @ ; P = @ ) for the effect of treatment once adjustments were made for demographic , prognostic and disease confounders .


Intention to treat and per-protocol analysis yielded similar results .


Sulodexide 's safety was comparable to that of the placebo .


Oral sulodexide therapy over @ months improved macular HE in patients with mild-to-moderate NPDR , without leading to detectable adverse events .


The study protocol was registered on clinicaltrial.gov under identifier NCT@ .


Mineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction .


We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction .


In this randomized , double-blind trial , we assigned @ patients with symptomatic heart failure and a left ventricular ejection fraction of @ % or more to receive either spironolactone ( @ to @ mg daily ) or placebo .


The primary outcome was a composite of death from cardiovascular causes , aborted cardiac arrest , or hospitalization for the management of heart failure .


With a mean follow-up of @ years , the primary outcome occurred in @ of @ patients in the spironolactone group ( @ % ) and @ of @ patients in the placebo group ( @ % ) ( hazard ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


Of the components of the primary outcome , only hospitalization for heart failure had a significantly lower incidence in the spironolactone group than in the placebo group ( @ patients -LSB- @ % -RSB- vs. @ patients -LSB- @ % -RSB- ; hazard ratio , @ ; @ % CI , @ to @ , P = @ ) .


Neither total deaths nor hospitalizations for any reason were significantly reduced by spironolactone .


Treatment with spironolactone was associated with increased serum creatinine levels and a doubling of the rate of hyperkalemia ( @ % , vs. @ % in the placebo group ) but reduced hypokalemia .


With frequent monitoring , there were no significant differences in the incidence of serious adverse events , a serum creatinine level of @ mg per deciliter ( @ mol per liter ) or higher , or dialysis .


In patients with heart failure and a preserved ejection fraction , treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome of death from cardiovascular causes , aborted cardiac arrest , or hospitalization for the management of heart failure .


( Funded by the National Heart , Lung , and Blood Institute ; TOPCAT ClinicalTrials.gov number , NCT@ . )


To compare the effectiveness and safety of fentanyl with placebo as pre-emptive treatment for pain associated with turning in patients in intensive care units .


Turning is frequently a painful procedure in this setting .


Pre-emptive administration of supplementary analgesia may help decrease this pain .


However , medical literature on pre-emptive analgesia in these patients is scarce .


A randomized , double-blind , controlled clinical trial .


This study will assess the benefits and risks of pre-emptive analgesia with fentanyl compared with placebo on turning-associated pain .


Eighty patients will be recruited from among those older than @ years and needing mechanical ventilation for at least @ hours .


Pain intensity will be assessed using the Behavioral Pain Scale .


Primary outcome will be pain intensity between the baseline and @ minutes after turning , measured by the area under the curve of the pain scale scores .


Secondary outcomes will be the usefulness of physiological parameters and the Bispectral Index to measure pain and the safety of pre-emptive fentanyl in turning .


The study protocol was approved in February @ .


If pre-emptive fentanyl is more effective than placebo and reasonably safe , the results of the current study may change nursing attitude in managing turning in critically ill patients .


As a consequence , pain may be decreased during this nursing procedure .


To study the associations of baseline gamma-glutamyltransferase ( GGT ) and alanine transaminase ( ALT ) with incident diabetes among Asian Indian men with impaired glucose tolerance ( IGT ) .


In a @ year prospective , randomised , controlled primary prevention study of diabetes , among @ IGT men aged @-@ years , @ incident diabetes ( DM ) cases occurred .


Anthropometric -LCB- body mass index ( BMI ) , waist circumference ( WC ) -RCB- , and laboratory measurements ( fasting , @ min and @ hr plasma glucose ( @ hr PG ) , HbA@c and plasma insulin , lipid profile , ALT , GGT ) were estimated at baseline ( Clinical Trial Identification No : NCT@ ) .


Predictive associations of baseline GGT and ALT values during the study were assessed using appropriate statistical methods .


Baseline GGT but not ALT was significantly higher in incident diabetes cases .


Mean ( @ % CI ) GGT decreased in subjects who reverted to normal glucose tolerance ( NGT ) , whereas it increased in subjects who deteriorated to diabetes ( NGT : -@ ( -@ to -@ ) ; IGT :@ ( -@ to @ ) ; DM :@ ( @ to @ ) UL ( -@ ) ; P < @ ) .


The risk of DM significantly increased with increasing baseline GGT after adjusting for confounders such as BMI , alcohol drinking , @ hr PG and insulin resistance ( @ -LSB- @-@ @ -RSB- ; P = @ ) .


Receiver operating characteristic curve showed that the model comprising of baseline fasting plasma glucose ( FPG ) and GGT ( area-under-curve ( AUC ) -LSB- @ % CI -RSB- : @ -LSB- @-@ @ -RSB- ; P < @ ) was equally sensitive in identifying subjects with risk of diabetes as compared to @ hr PG ( AUC -LSB- @ % CI -RSB- : @ -LSB- @-@ @ -RSB- ; P < @ ) and HbA@c ( AUC -LSB- @ % CI -RSB- : @ -LSB- @-@ @ -RSB- ; P < @ ) alone .


GGT was an independent predictor of incident diabetes .


Combination of GGT and FPG offers a simple and sensitive tool to identify subjects at high risk of developing diabetes .


To compare posterior capsule opacification ( PCO ) with @ intraocular lenses ( IOLs ) @ years postoperatively .


St. Erik Eye Hospital , Stockholm , Sweden .


Randomized clinical trial .


Patients having unilateral standard phacoemulsification were randomized to implantation of a round-edged heparin-surface-modified ( HSM ) poly ( methyl methacrylate ) ( PMMA ) IOL , a round-edged silicone IOL , or a sharp-edged hydrophobic acrylic IOL .


The neodymium : YAG ( Nd : YAG ) capsulotomy rates and timing from surgery were recorded .


Survival analysis was used to compare Nd : YAG rates .


Retroillumination images were taken to evaluate PCO .


After @ years , there was no significant difference in the fraction or severity of PCO between the silicone IOL and acrylic IOL .


The HSM PMMA IOL had a significantly higher PCO fraction than the silicone IOL ( P < @ ) , but not more than the acrylic IOL .


There was no difference in PCO severity between the HSM PMMA IOL and the other @ IOLs .


The silicone IOL had higher median capsulotomy-free survival ( > @ months ) than the acrylic IOL ( @ months ) and the HSM PMMA IOL ( @ months ) .


Overall survival without Nd : YAG capsulotomy did not differ between the acrylic and silicone IOLs or between the silicone and HSM PMMA IOLs ; however , overall survival was significantly better with the acrylic IOL than with the HSM PMMA IOL ( P < @ ) .


After @ years , there was no difference in PCO or overall survival without capsulotomy between the acrylic IOL and the silicone IOL .


The HSM PMMA IOL had a significantly higher PCO fraction than the silicone IOL and lower overall survival than the acrylic IOL .


To identify an appropriate therapeutic regimen for using aconite cake-separated moxibustion to treat diarrhea-predominant irritable bowel syndrome ( D-IBS ) .


A factorial design was employed to examine the two factors of moxibustion frequency and number of cones .


The two tested frequencies were three or six moxibustion sessions per week , and the two tested doses were one or two cones per treatment .


A total of @ D-IBS patients were randomly divided into four treatment groups , which included each combination of the examined frequencies and doses .


The bilateral Tianshu acupoints ( ST@ ) and the Qihai acupoint ( RN@ ) were selected for aconite cake-separated moxibustion .


Each patient received two courses of treatment , and each course had a duration of @ wk .


For each group , the scores on the Birmingham irritable bowel syndrome ( IBS ) symptom questionnaire , the IBS Quality of Life scale , the Self-Rating Depression Scale ( SDS ) , the Self-Rating Anxiety Scale ( SAS ) , the Hamilton Depression ( HAMD ) scale , and the Hamilton Anxiety ( HAMA ) scale were determined before treatment , after the first course of treatment , and after the second course of treatment .


The symptom , quality of life , SDS , SAS , HAMD , and HAMA scores of the patients in all @ aconite cake-separated moxibustion groups were significantly lower after the first and second courses of treatment than before treatment ( P < @ for all ) .


The symptom , quality of life , SDS , SAS , HAMD , and HAMA scores of the patients in all four aconite cake-separated moxibustion groups were significantly lower after the second course of treatment than after the first course of treatment ( P < @ for all ) .


Between-group comparisons after the second course of treatment revealed that the symptom scores for group @ ( @ cone , @ treatments/wk ) and group @ ( @ cones , @ treatments/wk ) were significantly lower than that for group @ ( @ cone , @ treatments/wk ) ( @ @ vs @ @ , P < @ ; @ @ vs @ @ , P < @ ) .


Regarding the two levels of the two examined factors for aconite cake-separated moxibustion , after the first course of treatment , the changes in HAMA scores were significantly different for the two tested moxibustion frequencies ( P = @ ) , with greater changes for the `` @ treatments/wk '' groups than for the `` @ treatments/wk '' groups ; in addition , there were interaction effects between the number of cones and moxibustion frequency ( P = @ ) .


After the second course of treatment , changes in symptom scores for the @ tested moxibustion frequencies were significantly different ( P = @ ) , with greater changes for the `` @ treatments/wk '' groups than for the `` @ treatments/wk '' groups .


An aconite cake-separated moxibustion treatment regimen of @ treatments/wk and @ cone/treatment appears to produce better therapeutic effects for D-IBS compared with the other tested regimens .


We sought to examine predictors and moderators of treatment outcomes among @ youths ages @-@ years ( @ % female ; @ % @ years ) meeting Diagnostic and Statistical Manual of Mental Disorders ( @th ed. , text rev. ; American Psychiatric Association , @ ) criteria for diagnoses of separation anxiety disorder , social phobia , or generalized anxiety disorder who were randomly assigned to receive either cognitive behavioral therapy ( CBT ) , sertraline ( SRT ) , their combination ( COMB ) , or medication management with pill placebo ( PBO ) in the Child/Adolescent Anxiety Multimodal Study ( CAMS ) .


Six classes of predictor and moderator variables ( @ variables ) were identified from the literature and examined using continuous ( Pediatric Anxiety Ratings Scale ; PARS ) and categorical ( Clinical Global Impression Scale-Improvement ; CGI-I ) outcome measures .


Three baseline variables predicted better outcomes ( independent of treatment condition ) on the PARS , including low anxiety severity ( as measured by parents and independent evaluators ) and caregiver strain .


No baseline variables were found to predict Week @ responder status ( CGI-I ) .


Participants ' principal diagnosis moderated treatment outcomes but only on the PARS .


No baseline variables were found to moderate treatment outcomes on Week @ responder status ( CGI-I ) .


Overall , anxious children responded favorably to CAMS treatments .


However , having more severe and impairing anxiety , greater caregiver strain , and a principal diagnosis of social phobia were associated with less favorable outcomes .


Clinical implications of these findings are discussed .


Emerging evidence has shown that epidural anesthesia could reduce the excessive stress response after surgery , and may help to preserve the body 's defenses against tumor progression in comparison with general anesthesia in malignant patients receiving operation .


This study aims to evaluate the effect of epidural anesthesia on postoperative immune suppression in gastric cancer patients undergoing radical resection .


Seventy one gastric cancer patients receiving radical resection were randomized to combined general/epidural anesthesia ( study group ) or general anesthesia alone ( control group ) .


Natural killer cell activity and serum concentrations of protumorigenic cytokines IL-@ and IL-@ , and antitumorigenic cytokines IL-@ and IL-@ were measured before anesthesia ( T@ ) , @h after skin incision ( T@ ) , and @h after skin incision ( T@ ) in both groups .


In both groups , the concentrations of IL-@ , IL-@ , and IL-@ increased at T@ and T@ when compared with T@ , whereas IL-@ concentration and NK cell activity decreased at T@ and T@ .


Furthermore , the study group exhibited less suppression of NK cell activity , higher levels of IL-@ and IL-@ , and lower levels of IL-@ and IL-@ in the early stage after operation , compared with the control group .


CONCLUSIOns : Combined general/epidural anesthesia seems to helpful to maintain the body 's perioperative immune function compared to general anesthesia alone in patients with gastric cancer operation .


The aim of this study was to evaluate the effects of a telephone-based self-care intervention among urban living individuals @ + years of age by comparing self-reported perceived health , mental health , sense of coherence , self-care ability , and self-care agency before and after the intervention .


In a randomized controlled study , @ persons answered a questionnaire about perceived health , mental health , sense of coherence , self-care ability , and self-care agency .


In a sex - and age-matched control group ( n = @ ) , the same questions were answered .


Data were collected before and after intervention .


An open-ended question about experiences of the intervention was included in the last questionnaire .


The intervention consisted of a first meeting with health professionals and additional five self-care telephone calls .


The control group did not receive any intervention or attention except for the questionnaires .


Descriptive statistics were used to describe the study group .


To compare the intervention group and control group on nominal and ordinal levels , the McNemar test and the Wilcoxon signed-rank test , respectively , were chosen .


Thirty individuals ( @ females and @ males ) participated in the study , ranging in age between @ and @ years .


A significant difference was obtained in the intervention group regarding mental health .


Mental health improved significantly in the intervention group ( P = @ ) .


In the control group , mental health , sense of coherence , self-care ability , and self-care agency showed worse outcome results after the intervention ( @ weeks ) .


Self-care telephone talks improved mental health significantly in our sample , and mental health focus could be understood as a possible condition for health promotion to take place .


Structured self-care telephone talks have proved to be successful and a relevant method to use in practice .


To explore and detail clinical experiences of dabigatran , a novel anticoagulant , after it became available in New Zealand in July @ .


A cohort of patients was recruited from Hutt Hospital and the two largest primary care practices in the Hutt Valley region .


They were included if they took at least one dose of dabigatran between July @ and April @ .


Participants undertook a questionnaire @-@ months after starting dabigatran assessing adherence , perceived side-effects and complications .


Those presenting due to an adverse event were analysed separately .


Of @ patients identified , @ were recruited to this study .


At a median of @ months , @ % of participants were still taking dabigatran , significantly lower than in the RE-LY trial at @ months ( P = @ ) .


The commonest reason given for discontinuation was gastrointestinal ( GI ) side-effects .


Rates of serious adverse outcomes on dabigatran therapy were relatively low .


Patients expressed polarised comments , both positive and negative , regarding their experiences of dabigatran .


A high rate of discontinuation of dabigatran , mainly due to GI symptoms , was observed .


There does not appear to be any specific predictor of dabigatran tolerance .


When prescribed according to guidelines , rates of serious adverse events associated with dabigatran appear to be low .


Peak creatine kinase ( CK ) - MB concentration is related to reperfusion success and clinical outcomes after fibrinolytic therapy for acute myocardial infarction .


However , prognostic implications of CK-MB measurements after primary percutaneous coronary intervention ( PCI ) , which provides more predictable and consistent reperfusion , are unknown .


We pooled @,@ primary PCI-treated ST-segment elevation myocardial infarction ( STEMI ) patients from @ trials with serial core laboratory-determined CK-MB measurements ; @,@ patients ( @ % ) who survived to @ hours and had @ CK-MB measurements were studied .


Cox regression modeling was performed to quantify the association between peak CK-MB concentration ( and area under the time-concentration curve -LSB- AUC -RSB- ) and mortality at @ months , and death or congestive heart failure at @ days .


The median ( @th-@th percentiles ) peak CK-MB concentration and AUC measurement through @ hours were @ ( @-@ ) ng/mL and @,@ ( @,@-@ ,@ ) ng / ( mL h ) , respectively .


By multivariable analysis , peak CK-MB concentration and AUC measurement were independently associated with @-month mortality ( adjusted hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ @ , per @-ng/mL increase , P = @ ; and adjusted HR @ , @ % CI @-@ @ , per @,@-ng / -LSB- mL h -RSB- increase , P < @ , respectively ) and @-day death or congestive heart failure ( adjusted HR @ , @ % CI @-@ @ , P < @ ; and adjusted HR @ , @ % CI @-@ @ , P < @ , respectively ) .


Peak CK-MB concentration and AUC measurement are independent predictors of @ - to @-month cardiovascular outcomes in primary PCI-treated STEMI patients .


Our findings guide application of these measurements as efficacy end points in early-phase studies evaluating new therapies for STEMI .


We conducted a pilot randomized trial of telephone-delivered acceptance and commitment therapy ( ACT ) versus cognitive behavioral therapy ( CBT ) for smoking cessation .


Participants were @ uninsured South Carolina State Quitline callers who were adult smokers ( at least @ cigarettes/day ) and who wanted to quit within the next @ days .


Participants were randomized to @ sessions of either ACT or CBT telephone counseling and were offered @ weeks of nicotine replacement therapy ( NRT ) .


ACT participants completed more calls than CBT participants ( M = @ in ACT vs. @ in CBT ; p = @ ) .


Regarding satisfaction , @ % of ACT participants reported their treatment was useful for quitting smoking ( vs. @ % for CBT ; p = @ ) , and @ % of ACT participants would recommend their treatment to a friend ( vs. @ % for CBT ; p = @ ) .


On the primary outcome of intent-to-treat @-day point prevalence abstinence at @ months postrandomization , the quit rates were @ % in ACT versus @ % in CBT ( odds ratio -LSB- OR -RSB- = @ , @ % confidence interval -LSB- CI -RSB- = @-@ @ ) .


Among participants depressed at baseline ( n = @ ) , the quit rates were @ % in ACT versus @ % in CBT ( OR = @ , @ % CI = @-@ @ ) .


Consistent with ACT 's theory , among participants scoring low on acceptance of cravings at baseline ( n = @ ) , the quit rates were @ % in ACT versus @ % in CBT ( OR = @ , @ % CI = @-@ @ ) .


ACT is feasible to deliver by phone , is highly acceptable to quitline callers , and shows highly promising quit rates compared with standard CBT quitline counseling .


As results were limited by the pilot design ( e.g. , small sample ) , a full-scale efficacy trial is now needed .


In patients with severe aortic stenosis , transcatheter aortic valve replacement ( TAVR ) improves survival when compared with nonsurgical therapy but with higher in-hospital and lifetime costs .


Complications associated with TAVR may decrease with greater experience and improved devices , thereby reducing the overall cost of the procedure .


Therefore , we sought to estimate the effect of periprocedural complications on in-hospital costs and length of stay of TAVR .


Using detailed cost data from @ TAVR patients enrolled in the Placement of Aortic Transcatheter Valve ( PARTNER ) I trial , we developed multivariable models to estimate the incremental cost and length of stay associated with specific periprocedural complications .


Attributable costs and length of stay for each complication were calculated by multiplying the independent cost of each event by its frequency in the treatment group .


Mean cost for the initial hospitalization was $ @ @ @ ( $ @ @ excluding the valve ) ; @ % of patients had @ complication .


Seven complications were independently associated with increased hospital costs , with major bleeding , arrhythmia , and death accounting for the largest attributable cost per patient .


Renal failure and the need for repeat TAVR , although less frequent , were also associated with substantial incremental and attributable costs .


Overall , complications accounted for $ @ @ per patient in initial hospital costs and @ days of hospitalization .


In the PARTNER trial , periprocedural complications were frequent , costly , and accounted for @ % of non-implant-related hospital costs .


Avoidance of complications should improve the cost-effectiveness of TAVR for inoperable and high-risk patients , but reductions in the cost of uncomplicated TAVR will also be necessary for optimal efficiency .


In a recent study one third of Lao patients presenting with uncomplicated Plasmodium falciparum malaria had biochemical evidence of thiamin deficiency , which was associated with a higher incidence of adverse events .


Thiamin supplementation might , therefore , reduce adverse events in this population .


An exploratory , double-blind , parallel group , placebo-controlled , superiority trial of thiamin supplementation in patients of all ages with uncomplicated and severe falciparum malaria was conducted in Xepon District , Savannakhet Province , southern Laos .


Patients were randomly assigned to either oral thiamin @ mg/day for @ days immediately after standard anti-malarial treatment then @ mg daily until day @ , or identical oral placebo .


After interim analyses when @ patients ( @ in thiamin and @ in placebo groups ) had been recruited , the trial was discontinued on the grounds of futility .


On admission biochemical thiamin deficiency ( alpha@ % ) was present in @ % of patients and @ % had severe deficiency ( alpha > @ % ) .


After @ days of treatment , the frequency of thiamin deficiency was lower in the thiamin ( @ % , @ % severe ) compared to the placebo ( @ % , @ % severe ) groups ( p < @ and p = @ ) , respectively .


Except for diarrhoea , @ % in the placebo compared to @ % in the thiamin group ( p = @ ) , and dizziness on day @ ( @ % vs @ % , p = @ ) , all adverse events were not significantly different between the groups ( p > @ ) .


Clinical , haematological , and parasitological responses to treatment did not differ significantly between the two groups .


Thiamin supplementation reduced biochemical thiamin deficiency among Lao malaria patients following anti-malarial drug treatment , but it did not reduce the frequency of adverse events after anti-malarial therapy or have any detected clinical or parasitological impact .


Chronic rhinosinusitis significantly impairs CF patients ' quality of life and overall health .


The Pari-Sinus device delivers vibrating aerosol effectively to paranasal sinuses .


After a small pilot study to assess sinonasal inhalation of dornase alfa and placebo ( isotonic saline ) on potential sinonasal outcome measures , we present the subsequent prospective double-blind placebo-controlled crossover-trial .


@ CF patients were randomised to inhale either dornase alfa or isotonic saline for @ days with the Pari-Sinus and after @ days ( wash-out ) crossed over to the alternative treatment .


The primary outcome parameter was primary nasal symptom score in the disease-specific quality of life Sino-Nasal Outcome-Test-@ ( SNOT-@ : nasal obstruction/sneezing/runny nose/thick nasal discharge/reduced smelling ) .


Primary nasal symptoms improved significantly with dornase alfa compared with no treatment , while small improvements with isotonic saline did not reach significance .


SNOT-@ overall scores improved significantly after dornase alfa compared with isotonic saline ( p = @ ) .


Additionally , sinonasal dornase alfa but not isotonic saline significantly improved pulmonary function ( FEF@-@ : p = @ ) .


Vibrating sinonasal inhalation of dornase alfa reduces rhinosinusitis symptoms in CF.


To determine the feasibility of conducting a randomized controlled trial comparing a low-sodium to a moderate-sodium diet in heart failure ( HF ) patients .


Patients with HF ( New York Heart Association classes II-III ) were randomized to low ( @ mg/d ) or moderate-sodium ( @ mg/d ) diet .


Dietary intake was evaluated using @-day food records .


The end points were changes in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire ( KCCQ ) scores and B-type natriuretic peptide ( BNP ) levels from baseline to @ months of follow-up presented as medians -LSB- @th , @th percentiles -RSB- .


Thirty-eight patients were enrolled ( @/group ) .


After @ months , median sodium intake declined from @ to @ mg/d in the low-sodium and from @ to @ mg/d in the moderate-sodium diet group .


Median BNP levels in the low-sodium diet group declined ( @-@ pg/mL , P = @ ) , whereas in the moderate-sodium diet group , there was no change in BNP ( @-@ pg/mL , P = @ ; P = @ between groups ) .


For @ months , median KCCQ clinical score increased in both groups ( @-@ -LSB- P = @ -RSB- in the low-sodium diet group and @-@ -LSB- P = @ -RSB- in the moderate-sodium group ; P = @ between groups ) .


At @ months , a post hoc analysis based on the dietary sodium intake achieved ( > or @,@ mg/d ) in all patients showed an association between a sodium intake @,@ mg/d and improvement in BNP levels and KCCQ scores .


A dietary intervention restricting sodium intake was feasible , and achievement of this sodium goal was associated with lower BNP levels and improved quality of life in patients with HF .


The aim of this article was to define risk factors for incidence of peripheral arterial disease ( PAD ) in a large cohort of patients with type @ diabetes mellitus ( T@DM ) , overall and within the context of differing glycemic control strategies .


The Bypass Angioplasty Revascularization Investigation in Type @ Diabetes ( BARI @D ) randomized controlled trial assigned participants to insulin-sensitizing ( IS ) therapy versus insulin-providing ( IP ) therapy .


A total of @,@ participants with normal ankle-brachial index ( ABI ) at study entry were eligible for analysis .


PAD outcomes included new ABI @ with decrease at least @ from baseline , lower extremity revascularization , or lower extremity amputation .


Baseline risk factors within the overall cohort and time-varying risk factors within each assigned glycemic control arm were assessed using Cox proportional hazards models .


During an average @ years of follow-up , @ participants ( @ % ) experienced an incident case of PAD .


Age , sex , race , and baseline smoking status were all significantly associated with incident PAD in the BARI @D cohort .


Additional baseline risk factors included pulse pressure , HbA@c , and albumin-to-creatinine ratio ( P < @ for each ) .


In stratified analyses of time-varying covariates , changes in BMI , LDL , HDL , systolic blood pressure , and pulse pressure were most predictive among IS patients , while change in HbA@c was most predictive among IP patients .


Among patients with T@DM , traditional cardiovascular risk factors were the main predictors of incident PAD cases .


Stratified analyses showed different risk factors were predictive for patients treated with IS medications versus those treated with IP medications .


To investigate the effects on plaque index ( PI ) scores of manual or electric toothbrush with or without repeated oral hygiene instructions ( OHI ) and motivation on patients wearing fixed orthodontic appliances .


One month after the orthodontic fixed appliance bonding on both arches , @ patients were randomly assigned to four groups ; groups E@ ( n = @ ) and E@ ( n = @ ) received a powered rotating-oscillating toothbrush , and groups M@ ( n = @ ) and M@ ( n = @ ) received a manual toothbrush .


Groups E@ and M@ received OHI and motivation at baseline ( T@ ) and after @ , @ , @ , @ , and @ weeks ( T@ , T@ , T@ , T@ , and T@ , respectively ) by a Registered Dental Hygienist ; groups E@ and M@ received OHI and motivation only at baseline .


At each time point a blinded examiner scored plaque of all teeth using the modified Quigley-Hein PI .


In all groups the PI score decreased significantly over time , and there were differences among groups at T@ , T@ , T@ , and T@ .


At T@ , PI scores of group E@ were lower than those of group E@ , and at T@ , T@ , and T@ , PI scores of groups M@ and E@ were lower compared to those of groups M@ and E@ .


A linear mixed model showed that the effect of repeated OHI and motivation during time was statistically significant , independently from the use of manual or electric toothbrush .


The present results showed that repeated OHI and motivation are crucial in reducing PI score in orthodontic patients , independent of the type of toothbrush used .


Anastomotic complications , including leaks , strictures/stenoses , and bleeding , cause considerable mortality and morbidity after colorectal surgery .