It was hypothesized that performance would be improved by both treatments , but response profiles would differ because the medications work via different mechanisms .


One hundred and two youth ( 77 male ; mean age = 10.5 2.7 years ) with ADHD received ATX ( 1.4 0.5 mg/kg ) and MPH ( 52.4 16.6 mg ) in a randomized , double-blind , crossover design .


Medication was titrated in 4-6-week blocks separated by a 2-week placebo washout .


Inhibitory control and attention measures were obtained at baseline , following washout , and at the end of each treatment using Conners ' Continuous Performance Test II ( CPT-II ) , which provided age-adjusted T-scores for reaction time ( RT ) , reaction time variability ( RT variability ) , and errors .


Repeated-measures analyses of variance were performed , with Time ( premedication , postmedication ) and Treatment type ( ATX , MPH ) entered as within-subject factors .


Data from the two treatment blocks were checked for order effects and combined if order effects were not present .


Clinicaltrials.gov : NCT00183391 .


Main effects for Time on RT ( p = .03 ) , RTSD ( p = .001 ) , and omission errors ( p = .01 ) were significant .


A significant Drug Time interaction indicated that MPH improved RT , RTSD , and omission errors more than ATX ( p < .05 ) .


Changes in performance with treatment did not correlate with changes in ADHD symptoms .


MPH has greater effects than ATX on CPT measures of sustained attention in youth with ADHD .


However , the dissociation of cognitive and behavioral change with treatment indicates that CPT measures can not be considered proxies for symptomatic improvement .


Further research on the dissociation of cognitive and behavioral endpoints for ADHD is indicated .


Low back pain is a common and costly health care problem .


This pilot study evaluated the sensitivity of the 2-stopwatch and Paris plinth methodologies for assessing time-to-onset of pain relief and flexibility , respectively , with continuous , low-level heatwrap therapy .


Subjects aged 18 to 55 years with at least moderate baseline acute low back pain were randomly assigned to either heatwrap or oral placebo for 8 hours .


Unheated wrap ( sham ) and oral ibuprofen were included for blinding purposes only .


Sixty-one subjects were randomly assigned to either heatwrap ( n = 26 ) , oral placebo ( n = 25 ) , sham wrap ( n = 5 ) , or oral ibuprofen ( n = 5 ) .


Median time to confirmed first perceptible pain relief and to meaningful pain relief were significantly shorter for the heatwrap group compared with those assigned to oral placebo ( 96.5 vs > 240.0 min and 215.7 vs > 240.0 min , respectively ; P < 0.05 for both ) .


Among subjects receiving the heatwrap , 53.8 % reported first perceptible and meaningful relief , compared with 28.0 % receiving oral placebo .


Subjective measures of pain relief , back stiffness , and global evaluation were more sensitive in detecting treatment differences than the plinth assessments of flexibility , range of motion , and pain .


Three adverse events were reported as mild in severity and considered unrelated to study treatment .


The 2-stopwatch methodology is a viable approach for assessing onset of analgesia in low back pain ; however , the plinth may not be a reliable method for assessing flexibility .


Consistent with published studies involving much larger sample sizes , the heatwrap provided significantly faster and sustained pain relief than oral placebo in subjects with acute low back pain .


Clinical Trial Identifier : NCT01045993 .


Trikatu is composed of dried fruits of Piper nigrum L and Piper retrofractum Vahl , and dried rhizomes of Zingiber officinale R. Although this preparation has been used to relieve pruritis , pain , and inflammation for a long time , there is no clinical evidence to confirm its efficacy and safety .


Therefore , we performed a double-blind , within person-randomized controlled study of 30 healthy volunteers to determine efficacy and safety of topical Trikatu on mosquito bite reactions .


All subjects were bitten by Aedes aegypti laboratory mosquitoes on their forearms and they were randomly assigned arms to apply either Trikatu or reference product on the mosquito bite papule .


The main outcome was the difference of papule size reduction at 30 min , measured by a caliper , between the Trikatu and reference arms .


Pruritis , redness , pain , and patient satisfaction were assessed at 15 , 30 , 60 , 180 , and 360 min as secondary outcomes .


There were no significant differences between treatment and reference arms on any outcome at any time of measurement .


Trikatu did not show additional effects for relieving mosquito bite reaction as compared with the reference product containing camphor , menthol , and eucalyptus .


For further study , it is very important to consider a proper selection of subjects , comparator product , and concentration of extract when Trikatu preparation is investigated .


We assessed the efficacy and safety of brodalumab , a human monoclonal antibody against interleukin-17 receptor A ( IL17RA ) , in a phase 2 , randomized , double-blind , placebo-controlled study involving patients with psoriatic arthritis .


We randomly assigned patients with active psoriatic arthritis to receive brodalumab ( 140 or 280 mg subcutaneously ) or placebo on day 1 and at weeks 1 , 2 , 4 , 6 , 8 , and 10 .


At week 12 , patients who had not discontinued their participation in the study were offered open-label brodalumab ( 280 mg ) every 2 weeks .


The primary end point was 20 % improvement in American College of Rheumatology response criteria ( ACR 20 ) at week 12 .


Of the 168 patients who underwent randomization ( 57 in the brodalumab 140-mg group , 56 in the brodalumab 280-mg group , and 55 in the placebo group ) , 159 completed the double-blind phase and 134 completed 40 weeks of the open-label extension .


At week 12 , the brodalumab 140-mg and 280-mg groups had higher rates of ACR 20 than the placebo group ( 37 % [ P = 0.03 ] and 39 % [ P = 0.02 ] , respectively , vs. 18 % ) ; they also had higher rates of 50 % improvement ( ACR 50 ) ( 14 % [ P = 0.05 ] and 14 % [ P = 0.05 ] vs. 4 % ) .


Rates of 70 % improvement were not significantly higher in the brodalumab groups .


Similar degrees of improvement were noted among patients who had received previous biologic therapy and those who had not received such therapy .


At week 24 , ACR 20 response rates in the brodalumab 140-mg and 280-mg groups were 51 % and 64 % , respectively , as compared with 44 % among patients who switched from placebo to open-label brodalumab ; responses were sustained through week 52 .


At week 12 , serious adverse events had occurred in 3 % of patients in the brodalumab groups and in 2 % of those in the placebo group .


Brodalumab significantly improved response rates among patients with psoriatic arthritis .


Larger studies of longer duration are necessary to assess adverse events .


( Funded by Amgen ; ClinicalTrials.gov number , NCT01516957 . )


Prolonged grief disorder ( PGD ) is a potentially disabling condition that affects approximately 10 % of bereaved people .


Grief-focused cognitive behavior therapy ( CBT ) has been shown to be effective in treating PGD .


Although treatments for PGD have focused on exposure therapy , much debate remains about whether exposure therapy is optimal for PGD .


To determine the relative efficacies of CBT with exposure therapy ( CBT/exposure ) or CBT alone for PGD .


A randomized clinical trial of 80 patients with PGD attending the outpatient University of New South Wales Traumatic Stress Clinic from September 17 , 2007 , through June 7 , 2010 .


All patients received 10 weekly 2-hour group therapy sessions that consisted of CBT techniques .


Patients also received 4 individual sessions , in which they were randomized to receive exposure therapy for memories of the death or supportive counseling .


Measures of PGD by clinical interview and self-reported measures of depression , cognitive appraisals , and functioning at the 6-month follow-up .


Intention-to-treat analyses at follow-up indicated a significant quadratic timetreatment condition interaction effect ( B [ SE ] , 0.49 [ 0.16 ] ; t120 .16 = 3.08 [ 95 % CI , 0.18-0 .81 ] ; P = .003 ) , indicating that CBT/exposure led to greater PGD reductions than CBT alone .


At follow-up , CBT/exposure led to greater reductions in depression ( B [ SE ] , 0.35 [ 0.12 ] ; t112 .65 = 2.83 [ 95 % CI , 0.11-0 .60 ] ; P = .005 ) , negative appraisals ( B [ SE ] , 0.68 [ 0.25 ] ; t109 .98 = 2.66 [ 95 % CI , 0.17-1 .18 ] ; P = .009 ) , and functional impairment ( B [ SE ] , 0.24 [ 0.08 ] ; t111 .40 = 3.01 [ 95 % CI , 0.08-0 .40 ] ; P = .003 ) than CBT alone .


In terms of treatment completers , fewer patients in the CBT/exposure condition at follow-up ( 14.8 % ) met criteria for PGD than those in the CBT condition ( 37.9 % ) ( odds ratio , 3.51 ; 95 % CI , 0.96-12 .89 ; 2 = 3.81 ; P = .04 ) .


Including exposure therapy that promotes emotional processing of memories of the death is an important component to achieve optimal reductions in PGD severity .


Facilitating emotional responses to the death may promote greater changes in appraisals about the loss , which are associated with symptom reduction .


Promotion of emotional processing techniques in therapies to treat patients with PGD is needed .


anzctr.org.au Identifier : ACTRN12609000229279 .


Colonoscopy is the recommended screening procedure for first-degree relatives of patients with colorectal cancer ( CRC ) , but few studies have compared its efficacy for CRC detection with that of other screening strategies .


We conducted a controlled randomized trial to compare the efficacy of repeated fecal immunochemical tests ( FITs ) and colonoscopy in detecting advanced neoplasia ( advanced adenoma or CRC ) in family members of patients with CRC .


In a prospective study , 1918 first-degree relatives of patients with CRC were randomly assigned ( 1:1 ratio ) to receive a single colonoscopy examination or 3 FITs ( 1/year for 3 years ; OC-Sensor ; cutoff 10 g hemoglobin/g feces , corresponding to 50 ng hemoglobin/mL buffer ) .


The strategies were considered to be equivalent if the 95 % confidence interval of the difference for the detection of advanced neoplasia was 3 % .


Follow-up analyses were performed to identify false-negative FIT results and interval CRCs .


Of all eligible asymptomatic first-degree relatives , 782 were included in the colonoscopy group and 784 in the FIT group .


In the intention-to-screen analysis , advanced neoplasia was detected in 33 ( 4.2 % ) and 44 ( 5.6 % ) first-degree relatives in the FIT and colonoscopy groups , respectively ( odds ratio = 1.41 ; 95 % confidence interval : 0.88-2 .26 ; P = .14 ) .


In the per-protocol analysis , 28 first-degree relatives ( 3.9 % ) in the FIT group and 43 ( 5.8 % ) in the colonoscopy group had advanced neoplasia ( odds ratio = 1.56 ; 95 % confidence interval : 0.95-2 .56 ; P = .08 ) .


FIT missed 16 of 41 advanced adenomas but no CRCs .


The FIT strategy required endoscopic evaluation of 4-fold fewer individuals to detect 1 advanced neoplasia than the colonoscopy strategy .


Repeated FIT screening ( 1/year for 3 years ) detected all CRCs and proved equivalent to colonoscopy in detecting advanced neoplasia in first-degree relatives of patients with CRC .


This strategy should be considered for populations where compliance with FITs is higher than with colonoscopy .


ClinicalTrials.gov number : NCT01075633 ( COLONFAM Study ) .


We had for aim to compare the effects of intra-operative opioid analgesia according to the drug kinetics .


We conducted a prospective , controlled , randomized , double-blinded trial including 60 patients scheduled for ambulatory multiple third molar avulsion .


The general anesthesia , performed with propofol and analgesia was a target-controlled infusion of either remifentanil or sufentanil .


The anesthesia was set to reach an optimal bispectral index and adjusted to a clinical target throughout the procedure .


The main endpoints were : postoperative request for morphine and other opioids ; postoperative pain ; postoperative adverse effects of opioids .


In the post-operative care unit ( French acronym PACU ) , patients who received remifentanil were extubated earlier ( 17 vs. 26 min . )


, but had more pain and required twice more morphine for analgesia ( 6 vs. 3 mg ) , than those who had received sufentanil .


However , the need for post-surgery oral opioid intake was greater in the sufentanil group , so the overall postoperative opioid consumption and patient satisfaction were identical in both groups .


The time spent in the PACU was also identical for both groups .


Using an ultra-short kinetic opioid such as remifentanil does not seem useful , since the shorter delay before extubation is compensated by a greater need for morphine in the PACU .


The first oxycodone once daily ( OOD ) has been developed and after successful pharmacokinetic characterization , therapeutic efficacy and safety were compared to an established oxycodone twice daily ( OTD : Oxygesic/OxyContin , Mundipharma ) .


A randomized , double-blind , multicenter , cross-over , non-inferiority study was conducted in patients ( n = 68 ) with chronic malignant or non-malignant pain .


The new OOD was compared to OTD at identical total daily doses ( TDD : 40-120mg / day ) employing intensive , five times daily current pain ( 0-100mm visual analog scale , VAS ) and twice daily 12h recalled pain assessments as well as safety parameters such as nausea and sedation ( VAS ) over 5 days for each treatment ( after a 5day run-in phase ) .


There was no significant difference in analgesic potency detected between the two treatments based on 95 % CI for difference in the daily mean current pain ( -2.09 mm VAS ) over 5 days , determined as -5.09 to 0.91 mm VAS .


A difference 12mm VAS indicated non-inferiority of OOD , i.e. lack of clinically relevant difference in analgesia .


Intake of rescue medication had no effect on study results as evaluated by ANCOVA .


The difference in adverse events ( AEs ) between the two treatments did not reach significance , as 19.1 % and 23.5 % of patients experienced treatment-related AEs while on OOD and OTD , respectively .


Advantages for OOD regarding consistency of analgesia ( i.e. use of rescue medication , current and recalled pain ) and sedation did not reach statistical significance in this limited study population .


Despite the small number of patients and short study duration , the results support the conclusion that new OOD is ( at least ) equivalent to established OTD regarding safety and efficacy .


To investigate factors mediating the effects of a European school-based intervention ( Unplugged ) based on a social influence approach to youths ' substance use .


Schools in seven European countries ( n = 143 , including 7,079 pupils ) were randomly assigned to an experimental condition ( Unplugged curriculum ) or a control condition ( usual health education ) .


Data were collected before ( pretest ) and 3 months after the end of the program ( posttest ) .


Multilevel multiple mediation models were applied to the study of effect mediation separately for tobacco , alcohol , and cannabis use .


Analyses were conducted on the whole sample , and separately on baseline users and nonusers of each substance .


Compared with the control group , participants in the program endorsed less positive attitudes toward drugs ; positive beliefs about cigarettes , alcohol , and cannabis ; and the normative perception of peers using tobacco and cannabis .


They also increased in knowledge about all substances and refusal skills toward tobacco .


Decreased positive attitudes toward drugs , increase in refusal skills , and reappraisal of norms about peer using tobacco and cannabis appeared to mediate the effects of the program on the use of substances .


However , mediating effects were generally weak and some of them were only marginally significant .


This study lends some support to the notion that school-based programs based on a social influence model may prevent juvenile substance use through the modification of attitudes , refusal skills , and normative perceptions .


Patients with heart failure ( HF ) have left ventricular dysfunction and reduced mean arterial pressure ( MAP ) .


Increased adrenergic drive causes vasoconstriction and vessel resistance maintaining MAP , while increasing peripheral vascular resistance and conduit vessel stiffness .


Increased pulse pressure ( PP ) reflects a complex interaction of the heart with the arterial and venous systems .


Increased PP is an important risk marker in patients with chronic HF ( CHF ) .


Non-invasive ventilation ( NIV ) has been used for acute decompensated HF , to improve congestion and ventilation through both respiratory and hemodynamic effects .


However , none of these studies have reported the effect of NIV on PP .


The objective of this study was to determine the acute effects of NIV with CPAP on PP in outpatients with CHF .


Following a double-blind , randomized , cross-over , and placebo-controlled protocol , twenty three patients with CHF ( 17 males ; 6011 years ; BMI 295 kg/cm2 , NYHA class II , III ) underwent CPAP via nasal mask for 30 min in a recumbent position .


Mask pressure was 6 cmH2O , whereas placebo was fixed at 0-1 cmH2O .


PP and other non invasive hemodynamics variables were assessed before , during and after placebo and CPAP mode .


CPAP decreased resting heart rate ( Pre : 729 ; vs. Post 5 min : 6710 bpm ; p < 0.01 ) and MAP ( CPAP : 8711 ; vs. control 9611 mmHg ; p < 0.05 post 5 min ) .


CPAP decreased PP ( CPAP : 4720 pre to 3819 mmHg post ; vs. control : 4212 mmHg , pre to 4118 post p < 0.05 post 5 min ) .


NIV with CPAP decreased pulse pressure in patients with stable CHF .


Future clinical trials should investigate whether this effect is associated with improved clinical outcome .


This study aims to evaluate the role of a decision aid intervention in knowledge of menopausal symptom management .


Five hundred fifteen U.S. women who had menopausal symptoms and had discussed symptom management with providers within the past 12 months were assigned to either receive a decision aid or not .


Participants completed a telephone survey 2 weeks after enrollment to assess knowledge .


Overall knowledge scores and knowledge scores for general symptoms , benefits of hormone therapy , and risks of HT were compared between the decision aid arm and the control arm .


Four hundred one women completed the survey .


Participants in the decision aid arm had a significantly higher mean ( SD ) knowledge score ( 63.3 % [ 18.4 % ] ) compared with the control arm ( 57.5 % [ 16.4 % ] ; P = 0.001 ) .


Specifically , participants in the decision aid arm had significantly higher scores for general symptoms ( mean difference , 11.0 ; 95 % CI , 5.3 to 16.6 ; P < 0.001 ) and knowledge about benefits of HT ( mean difference , 4.2 ; 95 % CI , 0.03 to 8.5 ; P = 0.048 ) compared with the control arm .


However , scores on knowledge about HT risks were not different between the arms ( mean difference , 2.1 ; 95 % CI , -3.0 to 7.2 ; P = 0.422 ) .


The decision aid arm has greater knowledge of menopausal symptom management compared with the control arm , although the difference is small .


In general , there is a considerable lack of knowledge about menopausal symptoms and HT risks .


To examine the association between odor identification deficits and future mortality in a multiethnic community cohort of older adults .


Participants were evaluated with the 40-item University of Pennsylvania Smell Identification Test ( UPSIT ) .


Follow-up occurred at 2-year intervals with information on death obtained from informant interviews and the National Death Index .


During follow-up ( mean = 4.1 years , standard deviation = 2.6 ) , 349 of 1,169 ( 29.9 % ) participants died .


Participants who died were more likely to be older ( p < 0.001 ) , be male ( p < 0.001 ) , have lower UPSIT scores ( p < 0.001 ) , and have a diagnosis of dementia ( p < 0.001 ) .


In a Cox model , the association between lower UPSIT score and mortality ( hazard ratio [ HR ] = 1.07 per point interval , 95 % confidence interval [ CI ] = 1.05-1 .08 , p < 0.001 ) persisted after controlling for age , gender , education , ethnicity , language , modified Charlson medical comorbidity index , dementia , depression , alcohol abuse , head injury , smoking , body mass index , and vision and hearing impairment ( HR = 1.05 , 95 % CI = 1.03-1 .07 , p < 0.001 ) .


Compared to the fourth quartile with the highest UPSIT scores , HRs for mortality for the first , second , and third quartiles of UPSIT scores were 3.81 ( 95 % CI = 2.71-5 .34 ) , 1.75 ( 95 % CI = 1.23-2 .50 ) , and 1.58 ( 95 % CI = 1.09-2 .30 ) , respectively .


Participant mortality rate was 45 % in the lowest quartile of UPSIT scores ( anosmia ) and 18 % in the highest quartile of UPSIT scores .


Impaired odor identification , particularly in the anosmic range , is associated with increased mortality in older adults even after controlling for dementia and medical comorbidity .


To compare the efficacy of air and octafluoropropane ( C3F8 ) in treating rhegmatogenous retinal detachments with inferior breaks after 23-gauge pars plana vitrectomy .


A prospective , randomized comparative interventional study .


Sixty-four patients with rhegmatogenous retinal detachment with inferior breaks underwent pars plana vitrectomy with air ( 32 eyes ) or gas ( 32 eyes ) tamponade .


Anatomical and visual outcomes of the two groups were compared .


The mean follow-up period was 13.09 1.90 months .


Significant differences were identified regarding prone positioning period ( P < 0.01 ) , intraocular pressure ( P < 0.01 ) , and gas volume ( P = 0.03 ) on the first postoperative day .


The single-operation success rates for the air and gas groups were 84.38 % and 78.13 % ( P = 0.522 ) , and the final surgery success rates increased to 100 % and 96.88 % ( P = 0.313 ) , respectively .


The single-operation success rate between the groups was not statistically significant , even after adjustment for confounding factors .


Multivariate logistic regression also indicated that the number of involved retinal quadrants ( odds ratio = 19.88 , P = 0.01 ) was an independent predictor of surgery failure .


The only postoperative complication observed was new or missed breaks , which occurred in 12 patients ( 18.75 % ) .


Air had equivalent tamponade effects to C3F8 , with a shorter prone positioning period , fewer complications , and less expense , in the surgical management of rhegmatogenous retinal detachment with inferior breaks .


The purpose of this study was to determine whether sonographic measurement of the inferior vena cava ( IVC ) in college football players during preseason camp is a reliable way to detect and monitor dehydration .


Our primary hypothesis was that IVC diameter measurements , the postpractice caval index , and expiratory diameter were significantly related to percent weight loss after a preseason football practice .


A prospective cohort sample of Division I intercollegiate football players in preseason training camp was recruited before practice .


All football players on the active roster who were at least 18 years of age were eligible to participate in the study .


Sonographic IVC measurements were obtained in the long axis using either the subcostal or subxiphoid approach during inspiration and expiration both before and after an approximately 3-hour practice with moderate to high levels of exertion at high ambient temperatures .


Player weights were recorded in the locker room before and after practice .


A total of 27 prepractice and postpractice sonographic measurements were obtained .


The postpractice expiratory IVC diameter was significantly related to percent weight loss after practice ( R ( 2 ) = 0.153 ; P = .042 ) , with the IVC diameter being significantly inversely correlated with percent weight loss ; the regression coefficient was -1.07 ( 95 % confidence interval , -2.09 to -0.04 ) .


There was no statistically significant relationship between percent weight loss and the postpractice caval index ; the regression coefficient was 0.245 ( 95 % confidence interval , -0.10 to 0.59 ; R ( 2 ) = 0.078 ; P = .16 ) .


The postpractice expiratory IVC diameter was significantly related to percent weight loss after practice , whereas the caval index was not found to correlate with weight loss .


We compared three methods of ultrasound-guided axillary brachial plexus block , which were single , and double perivascular ( PV ) infiltration techniques , and a perineural ( PN ) injection technique .


78 patients of American Society of Anesthesiologists physical status I-II undergoing surgery of the forearm , wrist , or hand were randomly allocated to three groups .


2 % lidocaine with epinephrine 5 g/mL was used .


The PN group ( n = 26 ) received injections at the median , ulnar , and radial nerve with 8 mL for each nerve .


The PV1 group ( n = 26 ) received a single injection of 24 mL at 12-o'clock position of the axillary artery .


The PV2 group ( n = 26 ) received two injections of 12 mL each at 12-o'clock and 6-o'clock position .


For all groups , musculocutaneous nerve was blocked separately .


The PN group ( 391.2171.6 sec ) had the longest anesthetic procedure duration than PV1 ( 192.859.0 sec ) and PV2 ( 211.458.6 sec ) .


There were no differences in onset time .


The average induction time was longer in PN group ( 673.4149.6 sec ) than PV1 ( 557.6194.9 sec ) and PV2 ( 561.5129.8 sec ) .


There were no differences in the success rate ( 89.7 % vs. 86.2 % vs. 89.7 % ) .


The PV injection technique consisting of a single injection in 12-o'clock position above the axillary artery in addition to a musculocutaneous nerve block is equally effective and less time consuming than the PN technique .


Therefore , the PV technique is an alternative method that may be used in busy clinics or for difficult cases .


Pasireotide , a multireceptor-targeted somatostatin analogue with efficacy in Cushing 's disease and acromegaly , can affect glucose metabolism due to inhibition of insulin secretion and incretin hormone responses .


A study was therefore conducted to evaluate different antihyperglycemic drugs in the management of pasireotide-associated hyperglycemia .


This was a 1-week , Phase I , open-label study .


Healthy male volunteers were randomized to pasireotide 600 g sc bid alone or co-administered with metformin 500 mg po bid , nateglinide 60 mg po tid , vildagliptin 50mg po bid , or liraglutide 0.6 mg sc qd .


An oral glucose tolerance test ( OGTT ) was performed on days 1 and 7 to evaluate effects on serum insulin , plasma glucose and glucagon levels .


Safety/tolerability and pharmacokinetic effects were also evaluated .


Ninety healthy male volunteers were enrolled ( n = 18 per arm ) .


After 7 days of treatment , plasma glucose AUC post-OGTT increased by 69 % with pasireotide alone .


The effect was reduced by 13 % , 29 % , 45 % and 72 % with co-administration of metformin , nateglinide , vildagliptin and liraglutide , respectively .


On day 7 , compared with pasireotide alone , the decrease in serum insulin was attenuated with nateglinide , metformin , liraglutide and vildagliptin co-administration ( levels were 3 % , 6 % , 34 % and 71 % higher , respectively ) .


Minimal changes in plasma glucagon were observed .


Adverse events were consistent with the safety profiles of the drugs used .


Vildagliptin and liraglutide were most effective in minimizing pasireotide-associated hyperglycemia in healthy volunteers .


Approximately 30 % higher grade premalignant oral intraepithelial neoplasia ( OIN ) lesions will progress to oral cancer .


Although surgery is the OIN treatment mainstay , many OIN lesions recur , which is highly problematic for both surgeons and patients .


This clinical trial assessed the chemopreventive efficacy of a natural product-based bioadhesive gel on OIN lesions .


This placebo-controlled multicenter study investigated the effects of topical application of bioadhesive gels that contained either 10 % w/w freeze-dried black raspberries ( BRB ) or an identical formulation devoid of BRB placebo to biopsy-confirmed OIN lesions ( 0.5 g q.i.d. , 12 weeks ) .


Baseline evaluative parameters ( size , histologic grade , LOH events ) were comparable in the randomly assigned BRB ( n = 22 ) and placebo ( n = 18 ) gel cohorts .


Evaluative parameters were : histologic grade , clinical size , and LOH .


Topical application of the BRB gel to OIN lesions resulted in statistically significant reductions in lesional sizes , histologic grades , and LOH events .


In contrast , placebo gel lesions demonstrated a significant increase in lesional size and no significant effects on histologic grade or LOH events .


Collectively , these data strongly support BRB 's chemopreventive impact .


A cohort of very BRB-responsive patients , as demonstrated by high therapeutic efficacy , was identified .


Corresponding protein profiling studies , which demonstrated higher pretreatment levels of BRB metabolic and keratinocyte differentiation enzymes in BRB-responsive lesions , reinforce the importance of local metabolism and differentiation competency .


Results from this trial substantiate the LOH reductions identified in the pilot BRB gel study and extend therapeutic effects to significant improvements in histologic grade and lesional size .


Unruptured intracranial aneurysm repair is the most commonly performed procedure for the prevention of hemorrhagic stroke .


Despite efforts to regionalize care in high-volume centers , overall results have improved little .


This study aims to determine the effectiveness in improving outcomes of previous efforts to regionalize unruptured intracranial aneurysm repair to high-volume centers and to recommend future steps toward that goal .


Using data obtained via the New York Statewide Planning and Research Cooperative System , this study included all patients admitted to any of the 10 highest volume centers in New York state between 2005 and 2010 with a principal diagnosis of unruptured intracranial aneurysm who were treated either by microsurgical or endovascular repair .


Mixed-effects logistic regression was used to determine the degree to which hospital-level and patient-level variables contributed to observed variation in good outcome , defined as discharge to home , between hospitals .


Of 3499 patients treated during the study period , 2692 ( 76.9 % ) were treated at the 10 highest volume centers , with 2198 ( 81.6 % ) experiencing a good outcome .


Good outcomes varied widely between centers , with 44.6 % to 91.1 % of clipped patients and 75.4 % to 92.1 % of coiled patients discharged home .


Mixed-effects logistic regression revealed that procedural volume accounts for 85.8 % of the between-hospital variation in outcome .


There is notable interhospital heterogeneity in outcomes among even the largest volume unruptured intracranial aneurysm referral centers .


Although further regionalization may be needed , mandatory participation in prospective , adjudicated registries will be necessary to reliably identify factors associated with superior outcomes .


Addiction constitutes a major public health problem , and despite treatment , relapse rates remain very high .


Preliminary findings suggest that Eye Movement Desensitization and Reprocessing ( EMDR ) , an evidence-based treatment for PTSD , may also reduce craving and relapse rates when applied in substance abuse .


This study aims to determine the feasibility , efficacy and effectiveness of EMDR when added to treatment as usual ( TAU ) for addiction in alcohol dependent outpatients , compared to TAU only .


A single blinded study in which 100 adult patients with a primary DSM-IV-TR diagnosis of alcohol dependence or abuse receiving treatment in one of six Dutch outpatient addiction care facility sites , will be enrolled .


After baseline assessment participants will be allocated to one of two treatment conditions ( allocation ratio of 1:1 ) using a stratified ( per site , per care pathway ) , blocked randomization procedure .


The intervention consists of EMDR ( seven weekly 90 minute sessions ) + TAU or TAU only .


Assessments are scheduled pre-treatment ( t0 ) , post-treatment ( t0 + eight weeks ) , and one and six months post treatment .


The effects of both treatment arms are compared on indices of ( a ) drinking behavior , ( b ) mediators , moderators and predictors of treatment outcome , ( c ) quality of life and d ) safety , acceptability and feasibility of treatment .


Repeated measures ANOVA 's will be conducted using an intention-to-treat and per-protocol approach .


Multiple imputation will be used to deal with missing values when possible .


This study adapts and extends the standard EMDR treatment for traumatized patients for use with patients with alcohol use disorders without psychological trauma .


ClinicalTrial.gov : NCT01828866 .


Cytomegalovirus ( CMV ) infection involves interaction between endothelial cells and leukocyte subsets that may promote vascular inflammation and lead to treatment failure in infected individuals .


Osteoprotegerin is a marker of vascular and systemic inflammation but has not been investigated in relation to treatment outcome during CMV infection .


We investigated whether circulating levels of osteoprotegerin are related to features of CMV disease and treatment outcomes during CMV infection in 291 solid organ transplant recipients receiving valganciclovir or ganciclovir in an international multicenter trial of CMV disease treatment ( the VICTOR study ) .


Elevated plasma osteoprotegerin was associated with ( i ) certain disease characteristics including presence of tissue invasive disease ( P < 0.05 ) and increased viral load at baseline ( P < 0.05 ) , ( ii ) poor virological outcome at day 49 after anti-CMV therapy , ( iii ) increased plasma levels of markers of inflammation ( pentraxin 3 and C-reactive protein ) and endothelial cell activation ( von Willebrand factor ) both at baseline and during follow-up .


Our finding indicates that elevated osteoprotegerin levels in solid organ transplant recipients with CMV infection may reflect vascular inflammation and is associated with late virological outcome in these patients .


To compare the efficacy of two mechanical devices for cervical ripening : double versus single balloon catheters , both with extra-amniotic saline infusion ( EASI ) .


Women at term with a singleton pregnancy presenting for labor induction were assigned to receive the double balloon catheter ( with EASI ) or the single balloon catheter ( with EASI ) .


Outcomes included time from device insertion to delivery , rates of successful vaginal delivery and occurrence of adverse events .


One hundred and eighty-six women completed the study .


Ripening success was comparable between the double and single balloon arms ( 96.4 % versus 92.7 % , p = 0.55 , respectively ) .


Balloon insertion to delivery interval was significantly shorter , and cesarean section rate was significantly lower in the double balloon arm compared with the single balloon arm ( 14.3 versus 15.8 h , p = 0.04 and 8.3 % versus 20 % , p = 0.05 , respectively ) .


There were no significant differences in maternal characteristics , satisfaction or adverse outcomes .


This study is the first documented assessment of the double balloon catheter combined with EASI .


Our findings suggest that the double balloon catheter results in reduced time to delivery and higher vaginal delivery rates , compared with the single balloon catheter with EASI , without compromising maternal or fetal safety .


Across the United States , tens of thousands of college students are mandated to receive an alcohol intervention following an alcohol policy violation .


Telephone interventions may be an efficient method to provide mandated students with an intervention , especially when they are away from campus during summer vacation .


However , little is known about the utility of telephone-delivered brief motivational interventions .


Participants in the study ( N = 57 ) were college students mandated to attend an alcohol program following a campus-based alcohol citation .


Participants were randomized to a brief motivational phone intervention ( pBMI ) ( n = 36 ) or assessment only ( n = 21 ) .


Ten participants ( 27.8 % ) randomized to the pBMI did not complete the intervention .


Follow-up assessments were conducted 3 , 6 , and 9 months post-intervention .


Results indicated the pBMI significantly reduced the number of alcohol-related problems compared to the assessment-only group .


Participants who did not complete the pBMI appeared to be lighter drinkers at baseline and randomization , suggesting the presence of alternate influences on alcohol-related problems .


Phone BMIs may be an efficient and cost-effective method to reduce harms associated with alcohol use by heavy-drinking mandated students during the summer months .


Epidemiologic and experimental data have suggested that chlorogenic acid , which is a polyphenol contained in green coffee beans , prevents diet-induced hepatic steatosis and insulin resistance .


We assessed whether the consumption of chlorogenic acid-rich coffee attenuates the effects of short-term fructose overfeeding , dietary conditions known to increase intrahepatocellular lipids ( IHCLs ) , and blood triglyceride concentrations and to decrease hepatic insulin sensitivity in healthy humans .


Effects of 3 different coffees were assessed in 10 healthy volunteers in a randomized , controlled , crossover trial .


IHCLs , hepatic glucose production ( HGP ) ( by 6,6-d2 glucose dilution ) , and fasting lipid oxidation were measured after 14 d of consumption of caffeinated coffee high in chlorogenic acid ( C-HCA ) , decaffeinated coffee high in chlorogenic acid , or decaffeinated coffee with regular amounts of chlorogenic acid ( D-RCA ) ; during the last 6 d of the study , the weight-maintenance diet of subjects was supplemented with 4 g fructose kg ( -1 ) d ( -1 ) ( total energy intake SD : 143 1 % of weight-maintenance requirements ) .


All participants were also studied without coffee supplementation , either with 4 g fructose kg ( -1 ) d ( -1 ) ( high fructose only ) or without high fructose ( control ) .


Compared with the control diet , the high-fructose diet significantly increased IHCLs by 102 36 % and HGP by 16 3 % and decreased fasting lipid oxidation by 100 29 % ( all P < 0.05 ) .


All 3 coffees significantly decreased HGP .


Fasting lipid oxidation increased with C-HCA and D-RCA ( P < 0.05 ) .


None of the 3 coffees significantly altered IHCLs .


Coffee consumption attenuates hepatic insulin resistance but not the increase of IHCLs induced by fructose overfeeding .


This effect does not appear to be mediated by differences in the caffeine or chlorogenic acid content .


This trial was registered at clinicaltrials.gov as NCT00827450 .


High-sensitivity C-reactive protein ( hsCRP ) is an important biomarker of risk for coronary heart disease morbidity and mortality .


We investigated the influence of short-term cardiac rehabilitation ( CR ) after acute myocardial infarction ( AMI ) on values of hsCRP and classical risk factors , including metabolic syndrome .


hsCRP and classical risk factors were measured before and after completed 2-week CR program in 30 men after AMI .


The comparison group comprised 30 age-balanced healthy men , with no risk factors for coronary heart disease .


As expected , in comparison to healthy individuals , patients had higher values of hsCRP ; furthermore , smokers had significantly higher hsCRP values than nonsmokers .


Patients had more expressed markers of metabolic syndrome and due to pharmacological therapy lower blood pressure , total cholesterol and low-density lipoprotein cholesterol ( LDL-C ) .


After CR was completed , a significant drop in hsCRP ( P = 0.006 ) and improvement of metabolic syndrome parameters ( lower body mass index , blood pressure , LDL-C , triglycerides ) was observed in nonsmokers , whereas no such changes occurred in smokers .


Our study revealed that hsCRP and metabolic syndrome parameters can be substantially reduced by a 2-week CR program ; however , this effect is present only in nonsmokers .


Thus , all patients entering the CR program after AMI should be advised to quit smoking before entering the program to achieve optimal benefits .


Many children do not engage in recommended levels of physical activity ( PA ) , highlighting the need to find ways to increase children 's PA. .


Process evaluations play an important role in improving the science of randomised controlled trials .


We recently reported the results of the Action 3:30 cluster randomised feasibility trial illustrating higher levels of moderate to vigorous intensity PA among boys but not girls .


The aim of this paper is to report the process evaluation results including intervention fidelity , implementation , context and how intervention components and trial design could be improved before proceeding to a definitive RCT .


Children 's session enjoyment was assessed every two weeks .


Reasons for non-attendance were provided by questionnaire at the end of the intervention .


Post intervention interviews were held with participating teaching assistants ( TAs ) and school key contacts ( KCs ) , and focus groups were conducted with children in all 10 intervention schools .


Interviews and focus groups examined how recruitment and session attendance might be improved and established which elements of the programme that were and were not well received .


Data indicated good intervention fidelity with TA 's adopting enjoyment-focussed teaching styles and the sessions improving children 's skills and self-esteem .


Several positive aspects of implementation were identified , including high session variety , the opportunity to work in teams , the child-led sessions and the engaging leader style .


In terms of context there was evidence that TA 's faced difficulties managing challenging behaviour and that further training in this area was needed .


TAs and KCs felt that recruitment could be improved by providing taster sessions during PE lessons and clarifying the days that the clubs would run at the point of recruitment .


The programme could be improved to enhance interest for girls , by including training for managing disruptive behaviour and making some activities more age-group appropriate .


Action 3.30 showed promise but could be improved by ensuring age appropriate activities , providing more appeal to girls and improving recruitment through taster sessions and early establishment of days of the week it is to be offered on .


ISRCTN58502739 .


Increasing evidence suggests obesity has its origins prior to birth .


There is clear correlation between maternal obesity , high birthweight and offspring risk of obesity in later life .


It is also clear that women who are obese during pregnancy are at greater risk of adverse outcomes , including gestational diabetes and stillbirth .


The mechanism ( s ) by which obesity causes these problems is unknown , although hyperglycaemia and insulin resistance are strongly implicated .


We present a protocol for a study to test the hypothesis that metformin will improve insulin sensitivity in obese pregnant women , thereby reducing the incidence of high birthweight babies and other pregnancy complications .


The Efficacy of Metformin in Pregnant Obese Women , a Randomised controlled ( EMPOWaR ) trial is a double-masked randomised placebo-controlled trial to determine whether metformin given to obese ( body mass index > 30kg/m ( 2 ) ) pregnant women from 16weeks ' gestation until delivery reduces the incidence of high birthweight babies .


A secondary aim is to test the mechanism ( s ) of any effect .


Obese women with a singleton pregnancy and normal glucose tolerance will be recruited prior to 16weeks ' gestation and prescribed study medication , metformin or placebo , to be taken until delivery .


Further study visits will occur at 28 and 36weeks ' gestation for glucose tolerance testing and to record anthropometric measurements .


Birth weight and other measurements will be recorded at time of delivery .


Anthropometry of mother and baby will be performed at 3months postdelivery .


As of January 2014 , 449 women had been randomised across the UK .


The study will be conducted in accordance with the principles of Good Clinical Practice .


A favourable ethical opinion was obtained from Scotland A Research Ethics Committee , reference number 10/MRE00/12 .


Results will be disseminated at conferences and published in peer-reviewed journals .


ISRCTN51279843 .


Dissociation between plasma-free cortisol and total cortisol profiles exists in critical illness .


Data on plasma-free cortisol are based on either calculated values or immunoassay-based measurements .


Both have significant limitations .


Statins have been advocated as a therapy in sepsis .


Whether they impact on plasma cortisol through inhibition of cholesterol synthesis is unclear .


In patients enrolled into a randomized trial of statins in sepsis ( n = 250 ) , we examined the association of mass spectrometry measured plasma-free cortisol , plasma-free cortisol/plasma total cortisol ratios , and outcome and the impact of concomitant statin therapy on cortisol profiles in 80 steroid nave patients .


Two hundred twenty serial measurements of plasma-free cortisol , plasma total cortisol , and interleukin-6 were collected from 80 patients ( 43 placebo and 37 statins ) .


Data from 10 volunteers were used as controls .


Data are presented as median and interquartile range .


Compared with controls , in severe sepsis , baseline plasma total cortisol was elevated two-fold ( 463 nmol/L [ 284-742 nmol/L ] vs 245 nmol/L [ 200-299 nmol/L ] , p < 0.001 ) , plasma-free cortisol 20-fold ( 75 nmol/L [ 20-151 nmol/L ] vs 5 nmol/L [ 5-7 nmol/L ] , p < 0.001 ) , and plasma-free cortisol/plasma total cortisol ratio six-fold ( 0.15 vs 0.02 , p = 0.058 ) .


Baseline interleukin-6 was elevated at 121 pg/mL ( 65-611 pg/mL ) .


In severe sepsis , there were no differences in plasma total cortisol ( p = 0.66 ) , plasma-free cortisol ( p = 0.77 ) , and interleukin-6 ( p = 0.29 ) between statins and placebo groups .


Plasma-free cortisol , plasma total cortisol , and plasma-free cortisol/plasma total cortisol were positively correlated with interleukin-6 ( p = 0.0001 , p < 0.0004 , and p < 0.001 , respectively ) and day 90 mortality ( p = 0.03 , p = 0.03 , and p = 0.058 , respectively ) .


Elevated plasma-free cortisol/plasma total cortisol ratios were associated with increased length of stay ( p = 0.04 ) .


Baseline plasma-free cortisol , plasma total cortisol , and plasma-free cortisol/plasma total cortisol ratios were higher in nonsurvivors as compared with survivors ( 174 nmol/L [ 77-329 nmol/L ] vs 57 nmol/L [ 17-122 nmol/L ] , p = 0.016 ; 890 nmol/L [ 333-1 ,430 nmol/L ] vs 408 nmol/L [ 269-681 nmol/L ] , p = 0.035 ; and 0.19 [ 0.13-0 .29 ] vs 0.14 [ 0.07-0 .20 ] ; p = 0.054 , respectively ) .


In severe sepsis , plasma-free cortisol increase is 10-fold greater than that of plasma total cortisol .


Both are similarly associated with inflammatory response and mortality .


Elevated plasma-free cortisol/plasma total cortisol ratios were associated with increased length of stay .


Statin therapy does not influence the plasma cortisol profiles in patients with severe sepsis .


The incidence of nosocomial infections in children in developed countries is still high , ranging from 8 % to 30 % , and standard preventive measures , such as increased hygiene , are not sufficiently efficacious .


One of the potential strategies for their prevention is the use of probiotics .


The aim of the study was to investigate the role of Bifidobacterium animalis subsp .


lactis in preventing nosocomial infections in the acute hospital setting .


We conducted a randomized , double-blind , placebo-controlled trial in 727 hospitalized children ( aged 1-18 y ) .


The children were randomly allocated to receive placebo ( placebo group , n = 365 ) or B. animalis subsp .


lactis at a dose of 10 ( 9 ) colony-forming units/d ( intervention group , n = 362 ) once daily for the entire duration of the hospital stay .


Nosocomial infections were defined as infections that occurred > 48 h after hospital admission and that were not present or incubating at the time of admission .


Analysis was performed on an intention-to-treat basis .


There was no difference in the study primary outcome or incidence of common nosocomial gastrointestinal and respiratory tract infections between groups ( 22 vs. 29 infections , respectively ; incidence rate ratio = 0.76 ; 95 % CI : 0.41 , 1.36 ; P = 0.32 ) .


No difference was found for the duration of common nosocomial infections [ mean ( range ) : 3.58 ( 1-7 ) vs. 3.79 ( 1-8 ) d , in placebo vs. intervention group ; P = 0.74 ] .


There was also no difference between the intervention and placebo groups for any of the other secondary outcomes ( incidence of gastrointestinal and respiratory tract infections separately , duration of gastrointestinal and respiratory infections , and duration of hospitalization ) and exploratory outcomes ( gastrointestinal and respiratory symptoms , severity of gastrointestinal and respiratory tract infections , and the use of antibiotics ) .


The results of this study show that the use of B. animalis subsp .


lactis failed to prevent nosocomial infections in an acute-setting pediatric hospital in children who were > 1 y of age .


However , it should be taken into account that the overall incidence of nosocomial infections was lower than expected .


This trial was registered at clinicaltrials.gov as NCT01702766 .


Hyperphosphatemia necessitates the use of phosphate binders in most dialysis patients .


Long-term efficacy and tolerability of the iron-based phosphate binder , sucroferric oxyhydroxide ( previously known as PA21 ) , was compared with that of sevelamer carbonate ( sevelamer ) in an open-label Phase III extension study .


In the initial Phase III study , hemo - or peritoneal dialysis patients with hyperphosphatemia were randomized 2:1 to receive sucroferric oxyhydroxide 1.0-3 .0 g/day ( 2-6 tablets/day ; n = 710 ) or sevelamer 2.4-14 .4 g/day ( 3-18 tablets/day ; n = 349 ) for 24 weeks .


Eligible patients could enter the 28-week extension study , continuing the same treatment and dose they were receiving at the end of the initial study .


Overall , 644 patients were available for efficacy analysis ( n = 384 sucroferric oxyhydroxide ; n = 260 sevelamer ) .


Serum phosphorus concentrations were maintained during the extension study .


Mean standard deviation ( SD ) change in serum phosphorus concentrations from extension study baseline to Week 52 end point was 0.02 0.52 mmol/L with sucroferric oxyhydroxide and 0.09 0.58 mmol/L with sevelamer .


Mean serum phosphorus concentrations remained within Kidney Disease Outcomes Quality Initiative target range ( 1.13-1 .78 mmol/L ) for both treatment groups .


Mean ( SD ) daily tablet number over the 28-week extension study was lower for sucroferric oxyhydroxide ( 4.0 1.5 ) versus sevelamer ( 10.1 6.6 ) .


Patient adherence was 86.2 % with sucroferric oxyhydroxide versus 76.9 % with sevelamer .


Mean serum ferritin concentrations increased over the extension study in both treatment groups , but transferrin saturation ( TSAT ) , iron and hemoglobin concentrations were generally stable .


Gastrointestinal-related adverse events were similar and occurred early with both treatments , but decreased over time .


The serum phosphorus-lowering effect of sucroferric oxyhydroxide was maintained over 1 year and associated with a lower pill burden , compared with sevelamer .


Sucroferric oxyhydroxide was generally well tolerated long-term and there was no evidence of iron accumulation .


Previous studies have already substantiated alcohol 's causal role in injuries .


Yet the role that alcoholic beverage preferences and the drinking context play in the risk for injury is still under-investigated .


In this study , a cross-national comparison of the association between alcohol and injury focusing on beverage type preference and the drinking context is reported .


Emergency department ( ED ) injured patients were interviewed in eight countries from the Latin American and Caribbean ( LAC ) region .


Data on the type of alcoholic beverage , total alcohol volume , and the place where the injury occurred were obtained from patients who reported any alcohol consumption within 6h prior to being injured .


Patients who did not drink prior to injury were also asked about their typical drinking pattern and the injury place .


Differences within - and between-groups were evaluated regarding patients ' typical drinking and drinking before injury .


Beer was the most prevalent beverage type usually consumed among injured patients across countries , however , patients who drank before injury had a higher typical consumption of spirits than those not drinking prior to injury .


The total alcohol volume typically consumed and drinking in public settings were also found to be positively associated with alcohol-related injury .


A similar beverage-specific association with alcohol-related injury was found across LAC countries , mainly attributed to beer consumption , and spirits drinkers seem to have a greater chance of becoming involved in injury events .


Future prevention strategies should inform the public about harms from drinking associated with the context in which drinking takes place .


Seasonal influenza causes > 200 000 annual hospitalizations in the United States .


Current antiviral treatment options are limited to oral or inhaled agents .


There is an urgent unmet need for intravenous antiviral treatments .


Patients hospitalized with suspected influenza were randomized to 5-day treatment with intravenous peramivir ( 600 mg once daily ) or placebo ; all received the institution 's standard of care ( SOC ) treatment .


Time to clinical resolution and change in viral shedding in nasopharyngeal specimens were the primary and key secondary end points .


Influenza infection was confirmed in 338 of 405 enrolled patients .


At the time of a preplanned interim analysis , the primary efficacy analysis population comprised 121 patients who did not receive a concurrent neuraminidase inhibitor as part of the SOC .


The median ( 95 % confidence interval ) time to clinical resolution was 42.5 ( 34.0-57 .9 ) hours for peramivir versus 49.5 ( 40.0-61 .9 ) hours for placebo ( P = .97 ) .


A larger treatment effect was observed in patients with history of symptoms < 48 hours or admitted to an intensive care unit .


Greater reductions in viral shedding , based on median tissue culture infective dose , were observed in patients who received peramivir than in placebo recipients , although this difference was not statistically significant .


The incidence and severity of adverse events and laboratory abnormalities were similar between the 2 treatment groups .


The study was terminated for futility after a preplanned interim analysis .


A significant clinical benefit was not demonstrated for peramivir plus SOC compared with placebo plus SOC .


Peramivir was generally safe and well tolerated .


These findings highlight the challenges in designing studies to evaluate influenza antiviral agents in a hospitalized setting .


Clinical Trials Registration.NCT00958776 .


The authors of this randomized study had for aim to evaluate the impact of training on proper glove use by comparing compliance to glove use recommendations between trained and untrained healthcare personnel according to healthcare professional groups .


A random selection of trained and untrained nurses , nurse aids , and hospital housekeepers was performed in a French University hospital , using a listing of healthcare personnel .


The audits were conducted by two infection control nurses , in series of 10 observations , with a maximum time limit of two hours .


The evaluation criteria were compliance or non-compliance of glove-wearing practices with internal hospital recommendations , disclosed to professionals during training .


Overall , 111 professionals were audited and 794 acts were observed .


Hand hygiene was significantly better in trained vs. untrained healthcare professionals ( P < 0.01 ) .


Proper glove use practices were similar between trained and untrained nurses ( 85 % of compliance ) , whereas the difference was statistically significant in favor of trained healthcare personnel for the other categories ( P < 0.001 for nurse aids and P = 0.02 for housekeepers ) .


We demonstrated the impact of pluridisciplinary training on proper glove use practices in hospital settings , but with different benefits found according to professional groups .


The lower the initial training level , the greater the overall benefit appeared to be .


To assess the reliability and validity of scores derived from the Patient Perception of Intensity of Urgency Scale ( PPIUS ) in patients with lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) .


A post hoc analysis of the phase II Solifenacin and Tamsulosin in Males with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia trial ( NCT00510406 ) , a 12-week clinical trial in men with LUTS associated with BPH , assessed the measurement properties of six PPIUS-derived scores : mean score ; maximum urgency score ; total urgency and frequency score ( TUFS ; average sum of urgency scores over 3 days ) ; and numbers of urgency episodes , urgency episodes of grade 3 or 4 , and urgency incontinence episodes .


Test-retest reliability , presence of floor/ceiling effects , responsiveness to change , known-group validity , and concurrent validity were assessed for each score .


A total of 901 patients had at least one valid PPIUS assessment after baseline .


TUFS demonstrated good test-retest reliability ( intraclass correlation coefficient > 0.8 ) , discriminated between groups defined based on International Prostate Symptom Score storage score severity ( known-groups validity ) , had high concurrent validity , and had high responsiveness to change ( Guyatt 's responsiveness statistic 0.88 ) , with an absence of floor or ceiling effects .


The psychometric properties of other PPIUS-derived scores were not as consistently robust and showed either low-to-moderate responsiveness , presence of a floor or ceiling effect , or low-to-moderate test-retest reliability .


This study shows that the PPIUS is reliable and valid in patients with LUTS associated with BPH .


TUFS provided the best combination of psychometric properties of the six scores derived from the PPIUS and appeared to be an appropriate measure of urgency and frequency .


In preclinical work and retrospective population studies , the anti-diabetic drug metformin has been associated with antineoplastic activity and decreased burden of many cancers , including pancreatic cancer .


There is therefore interest in the hypothesis that this drug might be repurposed for indications in oncology .


We aimed to assess the efficacy of the addition of metformin to a standard systemic therapy in patients with advanced pancreatic cancer , and provide the first report of a clinical trial with a survival endpoint of metformin for an oncological indication .


We did this double-blind , randomised , placebo-controlled phase 2 trial at four centres in the Netherlands .


Patients aged 18 years or older with advanced pancreatic cancer were randomly assigned ( 1:1 ) , via a permutated computer-generated block allocation scheme ( block size of six ) to receive intravenous gemcitabine ( 1000 mg/m ( 2 ) ) on days 1 , 8 , and 15 every 4 weeks and oral erlotinib ( 100mg ) once daily in combination with either oral metformin or placebo twice daily .


Metformin dose was escalated from 500 mg ( in the first week ) to 1000 mg twice daily in the second week .


Randomisation was stratified by hospital , diabetes status , and tumour stage .


The primary endpoint was overall survival at 6 months in the intention-to-treat population .


This trial is complete and is registered with ClinicalTrials.gov , number NCT01210911 .


Between May 31 , 2010 , and Jan 3 , 2014 , we randomly assigned 121 patients to receive gemcitabine and erlotinib with either placebo ( n = 61 ) or metformin ( n = 60 ) .


Overall survival at 6 months was 639 % ( 95 % CI 519-759 ) in the placebo group and 567 % ( 441-692 ) in the metformin group ( p = 041 ) .


There was no difference in overall survival between groups ( median 76 months [ 95 % CI 61-91 ] vs 68 months [ 95 % CI 51-85 ] in the metformin group ; hazard ratio [ HR ] 1056 [ 95 % CI 072-155 ] ; log-rank p = 078 ) .


The most frequent grade 3-4 toxic effects were neutropenia ( 15 [ 25 % ] patients in placebo group vs 15 [ 25 % ] in metformin group ) , skin rash ( six [ 10 % ] vs four [ 7 % ] ) , diarrhoea ( three [ 5 % ] vs six [ 10 % ] ) , and fatigue ( two [ 3 % ] vs six [ 10 % ] ) .


Addition of a conventional anti-diabetic dose of metformin does not improve outcome in patients with advanced pancreatic cancer treated with gemcitabine and erlotinib .


Future research should include studies of more potent biguanides , and should focus on patients with hyperinsulinaemia and patients with tumours showing markers of sensitivity to energetic stress , such as loss of function of AMP kinase , a key regulator of cellular energy homoeostasis .


Academic Medical Centre , Amsterdam , and The Terry Fox Foundation , Vancouver , Canada .


Prosthetic repair has become the standard method for hernia repair .


Mesh placement for the prevention of trocar site incisional hernia ( TSIH ) is still a controversial issue .


We tested the hypothesis that closure with an intraperitoneal prophylactic mesh of the umbilical trocar after a laparoscopic cholecystectomy can reduce the incidence of a TSIH in high-risk patients .


A randomized clinical trial was conducted among patients undergoing elective laparoscopic cholecystectomy who presented the following high-risk factors for incisional hernia , according to the literature : age 65 years and older , diabetes mellitus , chronic pulmonary disease , and obesity ( ie , body mass index 30 kg/m ( 2 ) ) .


Patients were assigned to have closure of the umbilical trocar site with either nonabsorbable sutures ( group A ) or intraperitoneal polypropylene omega-3 mesh ( group B ) .


Trocar site incisional hernia , pain , and surgical complications were evaluated at the early postoperative course and at 1 , 6 , and 12 months after surgery .


A total of 106 patients were randomized into the study and 92 patients were finally analyzed , including 47 in group A and 45 in group B.


The TSIH rate was higher in group A ( 31.9 % ) than in group B ( 4.4 % ) ( odds ratio = 10.1 ; 95 % CI , 2.15-47 .6 ; p < 0.001 ) ) .


The wound infection rate was 4.3 % ; 8.5 % in group A and 0 % in group B ( odds ratio = 2.04 ; 95 % CI , 1.7-2 .5 ; p = 0.045 ) .


Median postoperative pain evaluated by a visual analogue scale was 3 in group A and 2 in group B ( p = 0.05 ) .


No differences were observed in complication rate , operative time , or hospital stay between the groups .


Prosthetic closure of the umbilical trocar site after laparoscopic surgery could become the standard method for preventing TSIH in high-risk patients .


Etamicastat is a dopamine - hydroxylase ( DH ) inhibitor currently in clinical development for the treatment of hypertension and heart failure .


This study assessed the tolerability , pharmacokinetics , and pharmacodynamics of etamicastat in patients with arterial hypertension .


This randomized , double-blind , placebo-controlled study was conducted in male patients aged between 18 and 65 years with mild to moderate hypertension .


Participants received once-daily doses of etamicastat 50 , 100 , or 200 mg or placebo for 10 days .


Antihypertensive effect was assessed by 24-hour ambulatory blood pressure monitoring ( ABPM ) .


The study enrolled 23 male volunteers , with ages between 49 and 64 years .


There were no serious adverse events reported .


All adverse events were mild to moderate in intensity and resolved without sequelae .


Etamicastat Tmax was 1 hour postdose , and mean t was 19 to 28 hours following repeated administration .


Etamicastat underwent N-acetylation by N-acetyltransferase 2 ( NAT2 ) , forming the metabolite BIA 5-961 .


Following repeated administration , mean etamicastat AUC was 2 - to 3-fold greater in poor acetylators than in rapid acetylators .


Approximately 50 % of the etamicastat dose was recovered in urine-30 % as unchanged etamicastat and 20 % as BIA 5-961 .


Dose-dependent decreases in systolic and diastolic blood pressure were observed after 10 days of treatment .


The mean ( 95 % CI ) decreases versus placebo in nighttime SBP were statistically significant with all 3 etamicastat doses ( 50 mg , -11.66 mm Hg [ -21.57 to -1.76 ; P < 0.05 ] ; 100 mg , -14.92 mm Hg [ -24.98 to -4.87 ; P < 0.01 ] ; and 200 mg , -13.62 mm Hg [ -22.29 to -3.95 ; P < 0.01 ] ) .


Etamicastat was well tolerated and showed a pharmacokinetic profile consistent with a once-daily regimen .


NAT2 phenotype markedly affected the pharmacokinetics .


The antihypertensive effect of etamicastat , assessed by 24-hour ABPM , was dose dependent up to 100 mg .


The assessment of etamicastat as a novel antihypertensive therapy requires further study in broader populations .


EudraCT trial registration 2008-002789-09 .


This study aims to assess possible wound complications of tympanoplasty and tympanomastoidectomy with or without postoperative mastoid dressing .


A total of 37 patients ( 22 females , 15 males ; mean age : 23.88 years ; range 9 to 64 years ) who underwent middle ear or mastoid operations via postauricular incision were included in this prospective , randomized , controlled study .


The patients were divided into two groups as having mastoid dressing ( n = 17 ) and nonmastoid dressing ( n = 20 ) .


Through a close follow-up , postoperative complications were noted and distance from mastoid scalp and auricular rim was measured .


The mean mastoid-helix distance of non-mastoid dressing group was found 17.2 mm in operated and 16.9 mm in non-operated ears .


The mean mastoid-helix distance of mastoid dressing group was 15.53 mm in operated ears and 16.47 mm in non-operated ears .


Skin erythema was seen in a patient .


There was no statistically significant increase in mastoid-helix distance ( p > 0.05 ) .


Tympanoplasty with or without mastoidectomy does not cause postoperative complication or protrusion of the ear , even if no mastoid dressing is used .


Our study results suggest no benefit of mastoid dressing after tympanoplasty with or without mastoidectomy .


This randomized clinical trial evaluates interscalene brachial plexus block ( ISB ) , general anaesthesia ( GA ) and the combination of both anaesthetic methods ( GA + ISB ) in patients undergoing shoulder arthroscopy .


From July 2011 until May 2012 , 120 patients ( male/female ) , aged 20-80 years , were allocated randomly to receive ISB ( 10 ml mepivacaine 1 % and 20 ml ropivacaine 0.375 % ) , GA ( propofol , sunfentanil , desflurane ) or ISB + GA. .


The primary outcome variable was opioid consumption at the day of surgery .


Anaesthesia times were analysed as secondary endpoints .


After surgery , 27 of 40 patients with a single ISB bypassed the recovery room ( p < 0.0001 ) .


Postoperative monitoring time was significantly shorter with single ISB compared with both other groups [ GA : 93 ( 5-182 ) min vs. GA + ISB : 57.5 ( 11-220 ) min vs. ISB : 35 ( 5-106 ) min , p < 0.0001 ] .


Opioid consumption was reduced using a single ISB at the day of surgery [ GA : n = 25 vs. GA + ISB : n = 10 vs. ISB : n = 10 , p = 0.0037 ] .


ISB is superior to GA and GA + ISB in patients undergoing shoulder arthroscopy in terms of faster recovery and analgesics consumption .


Bisphosphonates are routinely used in the treatment of metastatic bone disease from breast cancer to reduce pain and bone destruction .


Zoledronic acid given by intravenous infusion has been widely used , but places a substantial logistical burden on both patient and hospital .


As a result , the use of oral ibandronic acid has increased , despite the absence of comparative data .


In the ZICE trial , we compared oral ibandronic acid with intravenous zoledronic acid for the treatment of metastatic breast cancer to bone .


This phase 3 , open-label , parallel group active-controlled , multicentre , randomised , non-inferiority phase 3 study was done in 99 UK hospitals .


Eligibility criteria included at least one radiologically confirmed bone metastasis from a histologically confirmed breast cancer .


Patients with ECOG performance status 0 to 2 and clinical decision to treat with bisphosphonates within 3 months of randomisation were randomly assigned to receive 96 weeks of treatment with either intravenous zoledronic acid at 4 mg every 3-4 weeks or oral ibandronic acid 50 mg daily .


Randomisation ( 1:1 ) was done via a central computerised system within stratified block sizes of four .


Randomisation was stratified on whether patients had current or planned treatment with chemotherapy ; current or planned treatment with hormone therapy ; and whether they had a previous skeletal-related event within the last 3 months or had planned radiotherapy treatment to the bone or planned orthopaedic surgery due to bone metastases .


The primary non-inferiority endpoint was the frequency and timing of skeletal-related events over 96 weeks , analysed using a per-protocol analysis .


All active ( non-withdrawn ) patients have now reached the 96-week timepoint and the trial is now in long-term follow-up .


The trial is registered with ClinicalTrials.gov , number NCT00326820 .


Between Jan 13 , 2006 , and Oct 4 , 2010 , 705 patients were randomly assigned to receive ibandronic acid and 699 to receive zoledronic acid ; three patients withdrew immediately after randomisation .


The per-protocol analysis included 654 patients in the ibandronic acid group and 672 in the zoledronic acid group .


Annual rates of skeletal-related events were 0499 ( 95 % CI 0454-0549 ) with ibandronic acid and 0435 ( 0393-0480 ) with zoledronic acid ; the rate ratio for skeletal-related events was 1148 ( 95 % CI 0967-1362 ) .


The upper CI was greater than the margin of non-inferiority of 108 ; therefore , we could not reject the null hypothesis that ibandronic acid was inferior to zoledronic acid .


More patients in the zoledronic acid group had renal toxic effects than in the ibandronic acid group ( 226 [ 32 % ] of 697 vs 172 [ 24 % ] of 704 ) but rates of osteonecrosis of the jaw were low in both groups ( nine [ 1 % ] of 697 vs five [ < 1 % ] of 704 ) .


The most common grade 3 or 4 adverse events were fatigue ( 97 [ 14 % ] of 697 patients allocated zoledronic acid vs 98 [ 14 % ] of 704 allocated ibandronic acid ) , increased bone pain ( 91 [ corrected ] [ 13 % ] vs 85 [ corrected ] [ 12 % ] ) , joint pain ( 41 [ corrected ] [ 6 % ] vs 38 [ 5 % ] ) , infection ( 31 [ 5 % ] vs 23 [ corrected ] [ 3 % ] ) , and nausea or vomiting ( 38 [ 5 % ] vs 41 [ 6 % ] ) .


Our results suggest that zoledronic acid is preferable to ibandronic acid in preventing skeletal-related events caused by bone metastases .


However , both drugs have acceptable side-effect profiles and the oral formulation is more convenient , and could still be considered if the patient has a strong preference or if difficulties occur with intravenous infusions .


Roche Products Ltd ( educational grant ) , supported by National Institute for Health Research Cancer Network , following endorsement by Cancer Research UK ( CRUKE/04/022 ) .


To determine bispectral index ( BIS ) values produced by equipotent concentrations of commonly used volatile anaesthetics .


Female patients undergoing thyroidectomy were randomly assigned to receive isoflurane , sevoflurane or desflurane anaesthesia .


After induction , anaesthesia was maintained by the volatile agent at 1 minimum alveolar concentration and supplemented with remifentanil infusion .


BIS values were recorded during 1h surgical anaesthesia after a 15min equilibrium phase .


Time-averaged BIS value during the study period was significantly lower in the desflurane group ( n = 29 ) than the sevoflurane group ( n = 27 ) ( 37.04.9 vs 41.55.9 ) .


Duration of deep hypnosis ( BIS < 40 ) was significantly longer in the desflurane group than the sevoflurane group ( 40.220.7 vs 24.322.5 min ) .


There were no significant differences in any parameter between the isoflurane group ( n = 27 ) and any other group .


Desflurane produces a greater hypnotic effect than sevoflurane during equipotent anaesthesia .


Management of volatile anaesthesia using predetermined minimum alveolar concentration targets can lead to an unnecessarily long duration of deep hypnosis .


Diagnostic esophagogastroduodenoscopy ( EGD ) is uncomfortable for most patients .


We determined the efficacy of alprazolam , administered orally or sublingually , as premedication for sedation during EGD .


Adult EGD candidates were randomly allocated to four groups ( n = 55 , each group ) and received alprazolam ( 0.5 mg ) sublingually or orally , placebo sublingually or orally at 30 minutes before EGD .


Main outcome measures included procedure-related anxiety and pain/discomfort ( assessed using 11-point numeric scales ) , patient overall tolerance ( assessed using a 4-point Likert scale ) , need for intravenous sedation , and willingness to repeat the EGD if necessary .


Patients experienced greater reduction in anxiety score after medication with sublingual alprazolam ( mean 2.25 , standard deviation [ SD ] 1.73 ) compared with sublingual placebo ( mean 0.10 , standard error [ SE ] 0.15 ] ; P < 0.001 ) and oral alprazolam ( 0.63 , SE 0.14 ; P < 0.001 ) .


Also , pain/discomfort scores were lower with sublingual alprazolam compared with sublingual placebo ( 3.29 , SE 0.29 vs. 4.16 , SD 1.86 ; P = 0.024 ) , and with oral alprazolam compared with oral placebo ( 3.48 , SD 1.69 vs. 5.13 , SD 2.39 ; P < 0.001 ) .


Patient overall tolerance was better with sublingual alprazolam than with sublingual placebo ( P = 0.005 ) or with oral alprazolam ( P = 0.009 ) .


Regarding intravenous sedation , there was no difference between sublingual alprazolam and sublingual placebo ( 10.9 % vs. 10.9 % ; P = 0.619 ) or between oral alprazolam and oral placebo ( 9.0 % vs. 12.7 % ; P = 0.381 ) .


Willingness to repeat the procedure was greater with sublingual alprazolam than with sublingual placebo ( 50.9 % vs. 30.9 % ; P = 0.026 ) .


Sublingual alprazolam is an effective premedication for sedation during EGD .


It reduces anxiety and pain/discomfort related to EGD and increases patient tolerance and willingness to repeat the EGD if necessary .


NCT01949038 ClinicalTrials.gov .


Drug users ( DUs ) , a population that accounts for some of the fastest-growing human immunodeficiency virus ( HIV ) epidemics globally , lag behind other populations with regard to HIV-related outcomes .


We evaluated the role of voucher incentives on linkage and retention in care among DUs in India .


In this randomized clinical trial , 120 DUs who were aged 18 years , HIV-infected , antiretroviral therapy ( ART ) naive , and ART eligible and who reported drug use in the prior month were randomized to incentive ( INC ) or control ( CTL ) conditions for 12 months .


Participants randomized to the INC arm received incentives ( redeemable for food/household goods ) ranging in value from USD4 to USD8 for achieving prespecified targets ( eg , ART initiation , visits to ART center ) .


Subjects in the CTL group could win vouchers in prize-bowl drawings , but HIV care behaviors were not incentivized .


The primary endpoint was time to ART initiation .


Sixty participants each were randomized to the INC and CTL arms between December 2009 and September 2010 .


Participants in the INC arm were more likely to visit the government ART center ( 49 vs 33 ; P = .002 ) ; 27 participants in the INC and 16 participants in the CTL arm initiated ART ( P = .04 ; hazard ratio for ART = 2.33 [ 95 % confidence interval , 1.15-4 .73 ] ) .


Participants in the INC arm also had significantly more visits to the ART center ( median number of visits , 8 vs 3.5 ; P = .005 ) .


However , no difference in viral suppression was observed .


Modest voucher incentives improved linkage to and retention in HIV care , but did not significantly impact viral suppression among DUs in India , a disenfranchised and difficult-to-treat population .


NCT01031745 .


Obstructive sleep apnea ( OSA ) is associated with increased risk of cardiovascular and cerebrovascular disease resulting from intermittent hypoxia ( IH ) - induced inflammation .


Cyclooxygenase ( COX ) - formed prostanoids mediate the inflammatory response , and regulate blood pressure and cerebral blood flow ( CBF ) , but their role in blood pressure and CBF responses to IH is unknown .


Therefore , this study 's objective was to determine the role of prostanoids in cardiovascular and cerebrovascular responses to IH .


Twelve healthy , male participants underwent three , 6-hour IH exposures .


For 4 days before each IH exposure , participants ingested a placebo , indomethacin ( nonselective COX inhibitor ) , or Celebrex ( ) ( selective COX-2 inhibitor ) in a double-blind , randomized , crossover study design .


Pre - and post-IH blood pressure , CBF , and urinary prostanoids were assessed .


Additionally , blood pressure and urinary prostanoids were assessed in newly diagnosed , untreated OSA patients ( n = 33 ) .


Nonselective COX inhibition increased pre-IH blood pressure ( P 0.04 ) and decreased pre-IH CBF ( P = 0.04 ) while neither physiological variable was affected by COX-2 inhibition ( P 0.90 ) .


Post-IH , MAP was elevated ( P 0.05 ) and CBF was unchanged with placebo and nonselective COX inhibition .


Selective COX-2 inhibition abrogated the IH-induced MAP increase ( P = 0.19 ) , but resulted in lower post-IH CBF ( P = 0.01 ) .


Prostanoids were unaffected by IH , except prostaglandin E2 was elevated with the placebo ( P = 0.02 ) .


Finally , OSA patients had elevated blood pressure ( P 0.4 ) and COX-1 formed thromboxane A2 concentrations ( P = 0.02 ) .


COX-2 and COX-1 have divergent roles in modulating vascular responses to acute and chronic IH .


Moreover , COX-1 inhibition may mitigate cardiovascular and cerebrovascular morbidity in OSA .


www.clinicaltrials.gov .


Unique identifier : NCT01280006 .


The prognostic and predictive value of the proliferation marker Ki-67 was investigated in a randomized trial comparing accelerated radiotherapy with carbogen breathing and nicotinamide ( ARCON ) to accelerated radiotherapy in laryngeal carcinoma .


Labeling index of Ki-67 ( Li Ki-67 ) in immunohistochemically stained biopsies and the colocalization with carbonic anhydrase IX ( CAIX ) were related to tumor control and patient survival .


On average , node-positive patients had a higher Li Ki-67 ( median 14 % vs 8 % ; p < .01 ) .


In patients with a high Li Ki-67 , the 5-year regional control and metastases-free survival were 79 % versus 96 % ( p < .01 ) and 71 % versus 88 % ( p = .05 ) for accelerated radiotherapy and ARCON , respectively .


The 5-year local control and disease-specific survival were not significantly different .


Patients with low Ki-67 expression had an excellent outcome with accelerated radiotherapy alone .


Patients with laryngeal carcinomas with high proliferative activity are at increased risk of regional and distant metastases formation .


This risk can be reduced by treatment with ARCON .


Assessment and discussion of individual risk for breast cancer within the primary care setting are crucial to discussion of risk reduction and timely referral .


We conducted a randomized controlled trial of a multiethnic , multilingual sample of women ages 40 to 74 years from two primary care practices ( one academic , one safety net ) to test a breast cancer risk assessment and education intervention .


Patients were randomly assigned to control or intervention group .


All patients completed a baseline telephone survey and risk assessment ( via telephone for controls , via tablet computer in clinic waiting room before visit for intervention ) .


Intervention ( BreastCARE ) patients and their physicians received an individualized risk report to discuss during the visit .


One-week follow-up telephone surveys with all patients assessed patient-physician discussion of family cancer history , personal breast cancer risk , high-risk clinics , and genetic counseling/testing .


A total of 655 control and 580 intervention women completed the risk assessment and follow-up interview ; 25 % were high-risk by family history , Gail , or Breast Cancer Surveillance Consortium risk models .


BreastCARE increased discussions of family cancer history [ OR , 1.54 ; 95 % confidence interval ( CI ) , 1.25-1 .91 ] , personal breast cancer risk ( OR , 4.15 ; 95 % CI , 3.02-5 .70 ) , high-risk clinics ( OR , 3.84 ; 95 % CI , 2.13-6 .95 ) , and genetic counseling/testing ( OR , 2.22 ; 95 % CI , 1.34-3 .68 ) .


Among high-risk women , all intervention effects were stronger .


An intervention combining an easy-to-use , quick risk assessment tool with patient-centered risk reports at the point of care can successfully promote discussion of breast cancer risk reduction between patients and primary care physicians , particularly for high-risk women .


Next steps include scaling and dissemination of BreastCARE with integration into electronic medical record systems .


The medical priority dispatch system ( MPDS ) assists lay rescuers in protocol-driven telephone-assisted cardiopulmonary resuscitation ( CPR ) .


Our aim was to clarify which CPR instruction leads to sufficient compression depth .


This was an investigator-blinded , randomized , parallel group , simulation study to investigate 10min of chest compressions after the instruction `` push down firmly 5cm '' vs. `` push as hard as you can . ''


Primary outcome was defined as compression depth .


Secondary outcomes were participants exertion measured by Borg scale , provider 's systolic and diastolic blood pressure , and quality values measured by the skill-reporting program of the Resusci ( ) Anne Simulator manikin .


For the analysis of the primary outcome , we used a linear random intercept model to allow for the repeated measurements with the intervention as a covariate .


Thirteen participants were allocated to control and intervention .


One participant ( intervention ) dropped out after min 7 because of exhaustion .


Primary outcome showed a mean compression depth of 44.1 mm , with an inter-individual standard deviation ( SDb ) of 13.0 mm and an intra-individual standard deviation ( SDw ) of 6.7 mm for the control group vs. 46.1 mm and a SDb of 9.0 mm and SDw of 10.3 mm for the intervention group ( difference : 1.9 ; 95 % confidence interval -6.9 to 10.8 ; p = 0.66 ) .


Secondary outcomes showed no difference for exhaustion and CPR-quality values .


There is no difference in compression depth , quality of CPR , or physical strain on lay rescuers using the initial instruction `` push as hard as you can '' vs. the standard MPDS ( ) instruction `` push down firmly 5cm . ''


Antioxidant donor pretreatment is one of the pharmacologic strategy proposed to prevent renal ischemia-reperfusion injuries and delayed graft function ( DGF ) .


The aim of the study was to investigate whether a donor pretreatment with N-acetylcysteine ( NAC ) reduces the incidence of DGF in adult human kidney transplant recipients .


In this randomized , open-label , monocenter trial , 160 deceased heart-beating donors were allowed to perform 236 renal transplantations from September 2005 to December 2010 .


Donors were randomized to receive , in a single-blind controlled fashion , 600 mg of intravenous NAC 1 hr before and 2 hr after cerebral angiography performed to confirm brain death .


Primary endpoint was DGF defined by the need for at least one dialysis session within the first week or a serum creatinine level greater than 200 mol/L at day 7 after kidney transplantation .


The incidence of DGF was similar between donors pretreated with or without NAC ( 39/118 ; 33 % vs. 30/118 ; 25.4 % ; P = 0.19 ) .


Requirement for at least one dialysis session was not different between the NAC and No NAC groups ( 17/118 ; 14.4 % vs. 14/118 ; 11.8 % , P = 0.56 ) .


The two groups had comparable serum creatinine levels , estimated glomerular filtration rates , and daily urine output at days 1 , 7 , 15 , and 30 after kidney transplantation as well as at hospital discharge .


No difference in recipient mortality nor in 1-year kidney graft survival was observed .


Donor pretreatment with NAC does not improve delayed graft function after kidney transplantation .


Some anesthesiologists consider combined spinal epidural ( CSE ) analgesia as superior alternative to continuous labor epidural ( CLE ) analgesia .


However , during CSE , even small doses of intrathecally administered local anesthetics with opioids induce almost instant analgesia that precludes the testing of epidural catheters as well as early appreciation of failed epidural catheters .


To overcome the shortcomings of CSE analgesia , dural puncture epidural ( DPE ) analgesia had been devised .


The goals for the present study were to test whether DPE technique would provide superior and safer labor analgesia as compared to CLE technique .


131 ASA Class I , II and III pregnant patients who requested labor epidural analgesia consented for their participation in this prospective randomized study .


Group A patients received CLE analgesia for labor pain .


Group B patients received DPE analgesia for labor pain .


After exclusion of nineteen patients , final comparative data was available for 112 patients only [ Group A ( n = 63 ) versus Group B ( n = 49 ) ] .


Per our analysis , the only positive aspect for DPE analgesia as compared to CLE analgesia was that patients who received DPE analgesia reported lower incidence for immediate failures of labor analgesia ( P = 0.04 ) .


However , there was higher incidence of paresthesias while performing successful dural punctures ( P < 0.0001 ) .


Pre-insertion epidural depth assessment with ultrasound ( n = 112 ) correlated positively with the air-filled loss of resistance syringe technique ( r = 0.88 ; P < 0.0001 ) .


DPE technique did not provide superior labor analgesia as compared to CLE technique .


Technically , fewer immediate failures in labor analgesia but higher incidence of paresthesias were observed with DPE technique .


To determine whether the addition of 26weeks of subcutaneous peginterferon -- 2b could reduce the requirement for systemic corticosteroids and conventional immunosuppressive medication in patients with Behet 's disease ( BD ) .


We conducted a multicentre randomised trial in patients with BD requiring systemic therapy .


Patients were randomised to 26weeks of peginterferon -- 2b in addition to their standard care or to standard care only and followed 6-monthly for 3years with BD activity scores and quality of life questionnaires .


Patients at one centre had blood taken to measure regulatory T cells ( Tregs ) and Th17 cells .


72 patients were included .


At months 10-12 , while among the entire patient population there was no difference in the corticosteroid dose or immunosuppression use between the treatment groups ( adjusted OR 1.04 , 95 % CI 0.34 to 3.19 ) , post hoc analysis revealed that in patients who were on corticosteroids at baseline the corticosteroid requirement was significantly lower in the peginterferon -- 2b ( 6.5 ( 5-15 ) mg/day ) compared with the non-interferon group ( 10 ( 8.25-16 .5 ) mg/day , p = 0.039 ) .


Furthermore , there was a trend towards an improved quality of life that became significant by 36months ( p = 0.008 ) .


This was associated with a significant rise in Tregs and a decrease in Th17 cells which was still present at 1year and 6months after the interferon was stopped .


The safety profile was similar with adverse events in 10 % in both groups .


The addition of peginterferon -- 2b to the drug regime of BD patients did not significantly reduce their corticosteroid dose required at 1year .


However , in those on corticosteroids at baseline post hoc analysis demonstrated that the addition of peginterferon -- 2b did result in a significant reduction in corticosteroid dose with a significantly improved quality of life and trend to reduce other required immunosuppressive agents .


This effect was seen at 1year and associated with a rise in Tregs suggesting a possible mode for interferon action .


ISRCTN 36354474 ; EudraCT 2004-004301-18 .


Low levels of physical activity are common in patients with chronic obstructive pulmonary disease ( COPD ) , and a sedentary lifestyle is associated with poor outcomes including increased mortality , frequent hospitalizations , and poor health-related quality of life .


Internet-mediated physical activity interventions may increase physical activity and improve health outcomes in persons with COPD .


This manuscript describes the design and rationale of a randomized controlled trial that tests the effectiveness of Taking Healthy Steps , an Internet-mediated walking program for Veterans with COPD .


Taking Healthy Steps includes an uploading pedometer , a website , and an online community .


Eligible and consented patients wear a pedometer to obtain one week of baseline data and then are randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control .


The intervention arm receives iterative step-count feedback ; individualized step-count goals , motivational and informational messages , and access to an online community .


Wait list controls are notified that they are enrolled , but that their intervention will start in one year ; however , they keep the pedometer and have access to a static webpage .


Participants include 239 Veterans ( mean age 66.7 years , 93.7 % male ) with 155 randomized to Taking Healthy Steps and 84 to the wait list control arm ; rural-living ( 45.2 % ) ; ever-smokers ( 93.3 % ) ; and current smokers ( 25.1 % ) .


Baseline mean St. George 's Respiratory Questionnaire Total Score was 46.0 ; 30.5 % reported severe dyspnea ; and the average number of comorbid conditions was 4.9 .


Mean baseline daily step counts was 3497 ( + / - 2220 ) .


Veterans with COPD can be recruited to participate in an online walking program .


We successfully recruited a cohort of older Veterans with a significant level of disability including Veterans who live in rural areas using a remote national recruitment strategy .


Clinical Trials.gov NCT01102777 .


Methods to improve neurocognitive impairments are of important research interest .


This study sought to examine the synergistic effects of neurocognitive rehabilitation and antipsychotics for schizophrenia .


Subjects were 43 patients diagnosed with schizophrenia or schizoaffective disorder in a randomized trial of the effects of neurocognitive rehabilitation or a quasi-randomized experimental trial of supported employment with neurocognitive rehabilitation .


We compared the effects of risperidone and aripiprazole in neurocognitive rehabilitation for schizophrenia .


Subjects were divided into the following groups : ( i ) the control-risperidone group ( CR group ) ( n = 13 ) ; ( ii ) the rehabilitation-risperidone group ( RR group ) ( n = 9 ) ; ( iii ) the control-aripiprazole group ( CA group ) ( n = 10 ) ; and ( iv ) the rehabilitation-aripiprazole group ( RA group ) ( n = 11 ) .


Subjects in the rehabilitation group were engaged in computer-based cognitive exercises ( 24 sessions ) with bridging group ( 12 sessions ) over 12 weeks .


Psychiatric symptoms , neurocognitive functioning and social functioning assessments were evaluated at baseline and at 12 weeks .


A two-way anova with neurocognitive rehabilitation and antipsychotic medication as factors revealed a significant interaction effect on motor speed .


Working memory and motor speed significantly improved in the RA group compared with the CA group .


We found no significant improvements between the CR group and the RR group .


A synergistic effect of neurocognitive rehabilitation and aripiprazole was observed as improvement of motor speed .


In patients treated with aripiprazole , neurocognitive rehabilitation appeared to improve working memory and motor speed .


Further studies of synergistic effects of neurocognitive rehabilitation and antipsychotic medication are necessary to verify these findings .


The progression of heart failure is affected by several factors , including chronic stimulation of the - adrenoceptor .


This clinical study was designed to measure the effects of thoracic epidural analgesia ( TEA ) on the plasma levels of norepinephrine ( NE ) , cAMP , and cGMP in patients with heart failure and assess the clinical implication of TEA .


Forty patients with heart failure were randomly assigned to TEA ( TEA plus standard care ) and control groups ( standard care ) .


The plasma concentrations of cAMP , cGMP , brain natriuretic peptide ( BNP ) , and NE were measured using ELISA before treatment , the second and fourth weeks of treatment .


The plasma concentrations of cAMP , cGMP , BNP , and NE in the TEA group were significantly reduced by the fourth week compared to their initial concentrations ( P < 0.01 , for all parameters ) and the control group ( P < 0.05 , P < 0.05 , P < 0.01 , and P < 0.05 , respectively ) .


The values for left ventricular end diastolic diameter ( LVEDD ) , ejection fraction ( EF ) , and fractional shortening ( FS ) in the TEA group improved significantly compared to their initial values and the control group .


However , the changes in levels for these indices in the control group were no statistical significant compared to the initial levels .


TEA can effectively decrease the plasma concentrations of cAMP and cGMP and improve cardiac function in patients with heart failure .


The decreased levels of NE and cAMP occurred before the improvement in cardiac function , indicating that the abnormal epidural signal transduction can be corrected in patients with heart failure .


To examine the impact of a personal health record ( PHR ) on medication-use safety among older adults .


Online PHRs have potential as tools to manage health information .


We know little about how to make PHRs accessible for older adults and what effects this will have .


A PHR was designed and pretested with older adults and tested in a 6-month randomized controlled trial .


After completing mailed baseline questionnaires , eligible computer users aged 65 and over were randomized 3:1 to be given access to a PHR ( n = 802 ) or serve as a standard care control group ( n = 273 ) .


Follow-up questionnaires measured change from baseline medication use , medication reconciliation behaviors , and medication management problems .


Older adults were interested in keeping track of their health and medication information .


A majority ( 55.2 % ) logged into the PHR and used it , but only 16.1 % used it frequently .


At follow-up , those randomized to the PHR group were significantly less likely to use multiple non-steroidal anti-inflammatory drugs-the most common warning generated by the system ( viewed by 23 % of participants ) .


Compared with low/non-users , high users reported significantly more changes in medication use and improved medication reconciliation behaviors , and recognized significantly more side effects , but there was no difference in use of inappropriate medications or adherence measures .


PHRs can engage older adults for better medication self-management ; however , features that motivate continued use will be needed .


Longer-term studies of continued users will be required to evaluate the impact of these changes in behavior on patient health outcomes .


People with chronic heart failure ( HF ) suffer from numerous symptoms that worsen quality of life .


The CASA ( Collaborative Care to Alleviate Symptoms and Adjust to Illness ) intervention was designed to improve symptoms and quality of life by integrating palliative and psychosocial care into chronic care .


Our aim was to determine the feasibility and acceptability of CASA and identify necessary improvements .


We conducted a prospective mixed-methods pilot trial .


The CASA intervention included ( 1 ) nurse phone visits involving structured symptom assessments and guidelines to alleviate breathlessness , fatigue , pain , or depression ; ( 2 ) structured phone counseling targeting adjustment to illness and depression if present ; and ( 3 ) weekly team meetings with a palliative care specialist , cardiologist , and primary care physician focused on medical recommendations to primary care providers ( PCPs , physician or nurse practioners ) to improve symptoms .


Study subjects were outpatients with chronic HF from a Veteran 's Affairs hospital ( n = 15 ) and a university hospital ( n = 2 ) .


Measurements included feasibility ( cohort retention rate , medical recommendation implementation rate , missing data , quality of care ) and acceptability ( an end-of-study semi-structured participant interview ) .


Participants were male with a median age of 63 years .


One withdrew early and there were < 5 % missing data .


Overall , 85 % of 87 collaborative care team medical recommendations were implemented .


All participants who screened positive for depression were either treated for depression or thought to not have a depressive disorder .


In the qualitative interviews , patients reported a positive experience and provided several constructive critiques .


The CASA intervention was feasible based on participant enrollment , cohort retention , implementation of medical recommendations , minimal missing data , and acceptability .


Several intervention changes were made based on participant feedback .


Because respiratory muscle function plays a strong role in exercise capacity and cardiopulmonary response to exercise , systematic training and measurement of respiratory muscle function should be considered in stroke patients .