Functional capacity was significantly reduced in both groups on POD 5 ; however , Group SI showed better preservation of functional capacity ( P = 0.0001 ) .


Group SI had better postoperative clinical results , with lower incidence of atelectasis and pleural effusion ( P < 0.05 ) , lower pain scores ( P < 0.0001 ) , and shorter orotracheal intubation and hospitalization lengths ( P < 0.001 ) .


Sub-xyphoid pleural drain determined better functional capacity and exercise tolerance with a smaller pulmonary shunt fraction and improved clinical outcomes compared with intercostal pleural drainage after off-pump coronary artery bypass surgery .


Acute renal failure ( ARF ) requiring renal replacement therapy ( RRT ) occurs frequently in ICU patients and significantly affects mortality rates .


Previously , few large clinical trials investigated the impact of RRT modalities on patient outcomes .


Here we investigated the effect of two major RRT strategies ( intermittent hemodialysis ( IHD ) and continuous veno-venous hemofiltration ( CVVH ) ) on mortality and renal-related outcome measures .


This single-center prospective randomized controlled trial ( `` CONVINT '' ) included 252 critically ill patients ( 159 male ; mean age , 61.513.9 years ; Acute Physiology and Chronic Health Evaluation ( APACHE ) II score , 28.68.8 ) with dialysis-dependent ARF treated in the ICUs of a tertiary care academic center .


Patients were randomized to receive either daily IHD or CVVH .


The primary outcome measure was survival at 14 days after the end of RRT .


Secondary outcome measures included 30-day - , intensive care unit - , and intrahospital mortality , as well as course of disease severity/biomarkers and need for organ-support therapy .


At baseline , no differences in disease severity , distributions of age and gender , or suspected reasons for acute renal failure were observed .


Survival rates at 14 days after RRT were 39.5 % ( IHD ) versus 43.9 % ( CVVH ) ( odds ratio ( OR ) , 0.84 ; 95 % confidence interval ( CI ) , 0.49 to 1.41 ; P = 0.50 ) .


14-day - , 30-day , and all-cause intrahospital mortality rates were not different between the two groups ( all P > 0.5 ) .


No differences were observed in days on RRT , vasopressor days , days on ventilator , or ICU - / intrahospital length of stay .


In a monocentric RCT , we observed no statistically significant differences between the investigated treatment modalities regarding mortality , renal-related outcome measures , or survival at 14 days after RRT .


Our findings add to mounting data demonstrating that intermittent and continuous RRTs may be considered equivalent approaches for critically ill patients with dialysis-dependent acute renal failure .


NCT01228123 , clinicaltrials.gov .


Routine use of pulse oximetry has been associated with changes in bronchiolitis management and may have lowered the hospitalization threshold for patients with bronchiolitis .


To examine if infants with bronchiolitis whose displayed oximetry measurements have been artificially elevated 3 percentage points above true values experience hospitalization rates at least 15 % lower compared with infants with true values displayed .


Randomized , double-blind , parallel-group trial conducted from 2008 to 2013 in a tertiary-care pediatric emergency department in Toronto , Ontario , Canada .


Participants were 213 otherwise healthy infants aged 4 weeks to 12 months with mild to moderate bronchiolitis and true oxygen saturations of 88 % or higher .


Pulse oximetry measurements with true saturation values displayed or with altered saturation values displayed that have been increased 3 percentage points above true values .


The primary outcome was hospitalization within 72 hours , defined as inpatient admission within this interval or active hospital care for greater than 6 hours .


Secondary outcomes included the use of supplemental oxygen in the emergency department , level of physician agreement with discharge from the emergency department , length of emergency department stay , and unscheduled visits for bronchiolitis within 72 hours .


Forty-four of 108 patients ( 41 % ) in the true oximetry group and 26 of 105 ( 25 % ) in the altered oximetry group were hospitalized within 72 hours ( difference , 16 % [ 95 % CI for the difference , 3.6 % to 28.4 % ] ; P = .005 ) .


Using the emergency department physician as a random effect , the primary treatment effect remained significant ( adjusted odds ratio , 4.0 [ 95 % CI , 1.6 to 10.5 ] ; P = .009 ) .


None of the secondary outcomes were significantly different between the groups .


There were 23 of 108 ( 21.3 % ) subsequent unscheduled medical visits for bronchiolitis in the true oximetry group and 15 of 105 ( 14.3 % ) in the altered oximetry group ( difference , 7 % [ 95 % CI , -0.3 % to 0.2 % ] ; P = .18 ) .


Among infants presenting to an emergency department with mild to moderate bronchiolitis , those with an artificially elevated pulse oximetry reading were less likely to be hospitalized within 72 hours or to receive active hospital care for more than 6 hours than those with unaltered oximetry readings .


This suggests that oxygen saturation should not be the only factor in the decision to admit , and its use may need to be reevaluated .


clinicaltrials.gov Identifier : NCT00673946 .


Voluntary medical male circumcision ( VMMC ) is a priority HIV preventive intervention .


To facilitate VMMC scale-up , the World Health Organization is seeking circumcision techniques that are faster , easier , and safer than open surgical methods .


To compare open surgical circumcision with suturing v. the Unicirc disposable instrument plus tissue adhesive .


We conducted a non-blinded randomised controlled trial at an outpatient primary healthcare clinic in Cape Town , South Africa , with 2:1 allocation ratio of 150 male volunteers who were at least 18 years of age .


Our primary outcome was intraoperative time and secondary outcomes were ease of performance , post-operative pain , adverse events , time to healing , patient satisfaction and cosmetic result .


The intraoperative time was less with the Unicirc/adhesive technique ( median 13 v. 22.6 min , respectively ; p < 0.001 ) .


The intraoperative suturing rate was 17 % using the Unicirc device .


Other adverse events and wound healing outcomes were similar in both groups , but the cosmetic result was superior in the Unicirc group .


Doctors found the Unicirc procedure easier to perform and preferred it to the open surgical technique .


This study has important implications for the scale-up of VMMC services .


Excising the foreskin with the Unicirc instrument and sealing the wound with cyanoacrylate tissue adhesive in adults is quicker , easier to learn , and is potentially safer than open surgical VMMC .


Further studies should be conducted with the optimised device .


This new instrument has the potential to facilitate more rapid scale-up and save costs .


To assess the antidepressant efficacy of S-adenosyl methionine ( SAMe ) , a naturally occurring methyl donor , versus the selective serotonin reuptake inhibitor ( SSRI ) escitalopram and a placebo control ; and to determine whether serum histamine or carnitine levels modified treatment response .


We examined a subsample ( n = 144 ) from one site of a two-site study of adults with diagnosed Major Depressive Disorder ( MDD ) , recruited from 4/13/05 to 12/22/09 , who consented to the additional blood draw for serum histamine and carnitine levels .


After washout , eligible subjects were randomized to SAMe ( 1600-3200mg / daily ) , escitalopram ( 10-20mg / daily ) , or matching placebo for 12 weeks of double-blind treatment ( titration at week 6 in non-response ) .


On the primary outcome of the Hamilton Depression Rating Scale ( HAMD-17 ) , a significant difference in improvement was observed between groups from baseline to week 12 ( p = 0.039 ) .


The effect size from baseline to endpoint was moderate to large for SAMe versus placebo ( d = 0.74 ) .


SAMe was superior to placebo from week 1 , and to escitalopram during weeks 2 , 4 , and 6 .


No significant effect was found between escitalopram and placebo or SAMe .


Response rates ( HAMD-1750 % reduction ) at endpoint were 45 % , 31 % , and 26 % for SAMe , escitalopram , and placebo , respectively ; while remission rates ( HAM-D7 ) were 34 % for SAMe ( p = 0.003 ) , 23 % for escitalopram ( p = 0.023 ) , and 6 % for placebo .


No correlation between baseline histamine level and reduction of HAMD-17 score was found for either the SAMe or escitalopram groups .


Baseline carnitine levels were also not found to moderate response to either treatment .


While SAMe appears to be an effective antidepressant agent , the overall findings from the parent study ( which showed no significant difference between groups due to site differences ) must be taken into consideration .


These preliminary results provide encouraging evidence for the use of SAMe in the treatment of MDD .


Histamine and carnitine serum level may not necessarily moderate response to SAMe .


To assess the longterm safety and effectiveness of tocilizumab ( TCZ ) in systemic-onset juvenile idiopathic arthritis ( sJIA ) .


The longterm extension phase of 2 pivotal studies ( phase II with 11 patients and phase III with 56 patients ) in patients with active sJIA was analyzed .


Patients received open-label TCZ ( 8 mg/kg , every 2 weeks ) without concomitant use of disease-modifying antirheumatic drugs .


In total , 67 patients were enrolled .


All patients received corticosteroid at baseline .


Median duration of exposure to TCZ was 3.4 years .


Nine patients withdrew from the study [ 4 because of adverse events ( AE ) , 4 because of the development of anti-TCZ antibodies , and 1 because of inadequate response ] .


Rates of AE and serious AE were 803.7 / 100 patient-years ( PY ) and 34.7 / 100 PY , respectively .


The most common serious AE were infections ( 13.2 / 100 PY ) .


No cases of malignancy or death were reported .


Two serious infusion reactions were reported in patients testing negative for anti-TCZ antibodies .


One definite macrophage activation syndrome ( MAS ) case and 1 potential MAS case were identified .


American College of Rheumatology ( ACR ) response rates attained early in the TCZ treatment period were maintained throughout the study : at Week 168 , JIA ACR 30 , 50 , 70 , 90 , and 100 response rates were 80.3 % , 80.3 % , 75.4 % , 60.7 % , and 18.0 % , respectively .


In total , 22 of 67 patients ( 32.8 % ) completely discontinued corticosteroids without flare .


TCZ has demonstrated durability of effectiveness in the longterm treatment of children with sJIA and has shown good tolerability and a low discontinuation rate associated with AE , development of anti-TCZ antibodies , or inadequate response .


( ClinicalTrials.gov NCT00144599 and NCT00144612 ) .


( First Release March 15 2014 ; J Rheumatol 2014 ; 41:759 -67 ; doi :10.3899 / jrheum .130690 ) .


The purpose of this study was to determine the effects of a multinutritional supplement including amino acids , - hydroxy -- methylbutyrate ( HMB ) , and carbohydrates on cytokine responses to resistance exercise and training .


Seventeen healthy , college-aged men were randomly assigned to a Muscle Armor ( MA ; Abbott Nutrition , Columbus , OH ) or placebo supplement group and 12 weeks of resistance training .


An acute resistance exercise protocol was administered at 0 , 6 , and 12 weeks of training .


Venous blood samples at pre - , immediately post - , and 30-minutes postexercise were analyzed via bead multiplex immunoassay for 17 cytokines .


After 12 weeks of training , the MA group exhibited decreased interferon-gamma ( IFN - ) and interleukin ( IL ) -10 .


IL-1 differed by group at various times .


Granulocyte colony-stimulating factor ( G-CSF ) , granulocyte-macrophage colony-stimulating factor ( GM-CSF ) , IL-6 , IL-7 , IL-8 , IL-12p70 , IL-13 , IL-17 , monocyte chemoattractant protein-1 ( MCP-1 ) , and macrophage inflammatory protein-1 beta ( MIP-1 ) changed over the 12-week training period but did not differ by group .


Twelve weeks of resistance training alters the cytokine response to acute resistance exercise , and supplementation with HMB and amino acids appears to further augment this result .


To determine the short-term clinical effects of levosimendan in acute myocardial infarction ( AMI ) patients with myocardial stunning after emergency percutaneous coronary intervention ( PCI ) .


The study population consisted of 30 patients with AMI who received emergency PCI and satisfied the inclusion criteria .


Levosimendan was given as a continuous infusion of 0.1 g/kg/min for 24 h , and the remaining 10 patients received placebo treatment .


The patients were observed with invasive haemodynamic monitoring and were evaluated biochemically and echocardiographically before and after the drug infusion .


Following treatment , biochemical indices ( not including creatine kinase and its MB fraction ) were significantly lower in the levosimendan group than in the placebo group .


Meanwhile , left-ventricular ( LV ) end-systolic volume , mean pulmonary arterial pressure , pulmonary capillary wedge pressure and systemic vascular resistance were significantly reduced in the levosimendan group , whereas the early-to-late diastolic velocities ratio , LV ejection fraction , cardiac index and cardiac power index were increased .


Troponin I levels were reduced and fewer stunned and infarction segments were observed in the patients treated with levosimendan .


Levosimendan can significantly improve the myocardium function of patients with myocardial stunning after PCI .


Treatment with rosiglitazone , a peroxisome proliferator-activated receptor - agonist , in type 2 diabetic mellitus ( T2DM ) patients is under scrutiny because it affects adversely cardiovascular outcomes .


In T2DM patients , with existing coronary heart disease , short-term treatment with rosiglitazone increases myocardial glucose uptake ( MGU ) .


Serum metabolic and lipoprotein subclass changes , which may be associated with this rosiglitazone-induced improvement , are unknown .


Patients with both T2DM and coronary heart disease were separated into placebo ( n = 26 ) and treatment ( rosiglitazone 4-8 mg ; n = 25 ) groups .


After 16 weeks of treatment , serum NMR metabolomics was used to measure circulating low-molecular-weight metabolites and lipoprotein subclasses and lipids that are associated with T2DM before and after the treatment .


Significant metabolic measure changes after rosiglitazone treatment were correlated to MGU values assessed with [ ( 18 ) F ] fluorodeoxyglucose positron emission tomography .


Compared to placebo , the treatment significantly increased circulating glutamine and decreased lactate concentrations .


Circulating lactate concentrations showed a significant inverse association with MGU after rosiglitazone treatment .


In T2DM patients with existing coronary heart disease , short-term rosiglitazone treatment caused minor improvements in metabolism : serum lactate and glutamine concentrations changed , reflecting improvements in insulin sensitivity , and circulating lactate concentrations inversely correlated to increases in myocardial glucose uptake .


This study aims at ascertaining the capacity of 2 groups of young athletes to be faithful to the initial oral prevention project , with the difference that the study group received motivational reminders by either researchers and technical staff members of the team during the observation period , while the control group did not receive any motivational reminders .


This observational study was based on two groups selected from a wide group of 150 adolescent basketball players who accepted to use a custom-made mouth guard during their sport sessions .


None of the selected athletes ( 60 adolescents aged between 12 and 15 years ) had ever worn a mouth guard during their sports activity .


A customised mouth guard was supplied , and subjetcs were requested to wear it for 12 months during training sessions and competitions .


The study group was composed of 30 athletes , 15 males and 15 females , who received a constant motivational reinforcement to the use of the mouth guard by their coach and during checkups .


Similarly , the control group was composed of 30 athletes ( 15 males and 15 females ) who did not receive any motivational reinforcement .


Twelve months after the beginning of the study , 24 subjects belonging to the control group were not using the mouth guard , while only 7 subjects of the study group were not using it .


It was also noticed , six months after the beginning of the observation period , a rapid decline in the participants ' interest in the use of the mouth guard .


No traumatic event was registered among those adolescents who had used the mouth guard for the whole period of the study .


Female athletes showed greater compliance to this prevention project .


It is important that all technical staff members , and particularly the leading coach , encourage the regular use of oral protection devices for prevention among teenagers practicing sports .


Physical activity is important for a healthy lifestyle .


Although physical activity can delay complications and decrease the burden of the disease , the level of activity of patients with chronic obstructive pulmonary disease ( COPD ) or type 2 Diabetes Mellitus ( DM2 ) is often far from optimal .


To stimulate physical activity , a monitoring and feedback tool , consisting of an accelerometer linked to a smart phone and webserver ( It 's LiFe !


tool ) , and a counselling protocol for practice nurses in primary care was developed ( the Self-management Support Program ) .


The main objective of this study is to measure the longitudinal effects of this counselling protocol and the added value of using the tool .


This three-armed cluster randomised controlled trial with 120 participants with COPD and 120 participants with DM2 ( aged 40-70 ) , compares the counselling protocol with and without the use of the tool ( group 1 and 2 ) with usual care ( group 3 ) .


Recruitment takes place at GP practices in the southern regions of the Netherlands .


Randomisation takes place at the practice level .


The intended sample ( three arms of 8 practices ) powers the study to detect a 10-minute difference of moderate and intense physical activity per day between groups 1 and 3 .


Participants in the intervention groups have to visit the practice nurse 3-4 times for physical activity counselling , in a 4-6-month period .


Specific activity goals tailored to the individual patient 's preferences and needs will be set .


In addition , participants in group 1 will be instructed to use the tool in daily life .


The primary outcome , physical activity , will be measured in all groups with a physical activity monitor ( PAM ) .


Secondary outcomes are quality of life , general - and exercise - self-efficacy , and health status .


Follow-up will take place after 6 and 9months .


Separately , a process evaluation will be conducted to explore reasons for trial non-participation , and the intervention 's acceptability for participating patients and nurses .


Results of this study will give insight into the effects of the It 's LiFe !


monitoring and feedback tool combined with care from a practice nurse for people with COPD or DM2 on physical activity .


ClinicalTrials.gov : NCT01867970 .


Pre-exposure prophylaxis ( PrEP ) may be an important safer conception strategy for HIV-1-uninfected women with HIV-1-infected partners .


Understanding medication adherence in this population may inform whether PrEP is a feasible safer conception strategy .


We evaluated predictors of pregnancy and adherence to study medication among HIV-1-uninfected women enrolled in a randomized placebo-controlled trial of PrEP among African HIV-1-serodiscordant couples .


Participants were counseled on HIV-1 risk reduction , contraception , and adherence and tested for pregnancy at monthly study visits .


Pill counts of dispensed drug were performed and , at a subset of visits , plasma was collected to measure active drug concentration .


Among 1785 women , pregnancy incidence was 10.2 per 100 person-years .


Younger age , not using contraception , having an additional sexual partner , and reporting unprotected sex were associated with increased likelihood of pregnancy .


Monthly clinic pill counts estimated that women experiencing pregnancy took 97 % of prescribed doses overall , with at least 80 % pill adherence for 98 % of study months , and no difference in adherence in the periconception period compared with previous periods ( P = 0.98 ) .


Tenofovir was detected in plasma at 71 % of visits where pregnancy was discovered .


By multiple measures , adherence was similar for women experiencing and not experiencing pregnancy ( P 0.1 ) .


In this clinical trial of PrEP , pregnancy incidence was 10 % per year despite excellent access to effective contraception .


Women experiencing pregnancy had high medication adherence , suggesting that PrEP may be an acceptable and feasible safer conception strategy for HIV-1-uninfected women with HIV-1-serodiscordant partners .


Patients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of safety and efficacy is poor .


We have therefore studied the combination of different antithrombotic medicines for coagulation activation in an in vivo model in the skin microvasculature .


Platelet activation ( - thromboglobulin [ - TG ] ) and thrombin generation ( prothrombin fragment 1 + 2 [ F1 +2 ] , thrombin-antithrombin complex [ TAT ] ) were studied in an open-label , randomized , parallel group trial in 60 healthy male subjects ( n = 20 per group ) who received ticagrelor and acetylsalicylic acid ( ASA ) in combination with dabigatran ( 150 mg bid ) , rivaroxaban ( 20 mg od ) or phenprocoumon ( INR 2.0-3 .0 ) .


Coagulation biomarkers in shed blood were assessed at 3 h after monotherapy with the medicines under study , at 3 h after triple therapy dosing and at steady state trough conditions .


Single doses of ticagrelor , dabigatran or rivaroxaban caused comparable decreases in shed blood - TG and were more pronounced than phenprocoumon at an INR of 2.0-3 .0 .


In contrast , thrombin generation was more affected by rivaroxaban and phenprocoumon than by dabigatran .


During triple therapy a similarly sustained inhibition of platelet activation and thrombin generation with a maximum decrease of - TG , F1 +2 and TAT at 3 h post-dosing was noted , which remained below pre-dose levels at trough steady state .


A triple therapy at steady state with ticagrelor plus ASA in combination with dabigatran or rivaroxaban is as effective as a combination with phenprocoumon for platelet activation and thrombin generation in vivo .


Apremilast works intracellularly to regulate inflammatory mediators .


ESTEEM 1 evaluated efficacy/safety of apremilast at 30 mg twice a day for moderate to severe plaque psoriasis .


This phase III , multicenter , double-blind , placebo-controlled study randomized adults ( 2:1 ) to apremilast or placebo .


At week 16 , the placebo group switched to apremilast through week 32 , followed by a randomized treatment withdrawal phase to week 52 .


Binary end points were analyzed using ( 2 ) test ; continuous end points used analysis of covariance .


In all , 844 patients were randomized ( n = 282 , placebo ; n = 562 , apremilast ) .


At week 16 , significantly more patients taking apremilast achieved 75 % or greater reduction from baseline Psoriasis Area and Severity Index score ( PASI-75 ) ( 33.1 % ) versus placebo ( 5.3 % , P < .0001 ; primary end point ) .


Most ( 61.0 % ) patients rerandomized to apremilast at week 32 achieved PASI-75 at week 52 versus 11.7 % rerandomized to placebo .


Of patients rerandomized to apremilast at week 32 , mean percentage change from baseline PASI score was -88 % to -81 % ( weeks 32-52 ) .


During the placebo-controlled period , 55.7 % and 69.3 % of patients randomized toplacebo and apremilast , respectively , had 1 or more adverse events .


Most adverse events were mild/moderate in severity .


No new significant adverse events emerged with continued apremilast exposure versus the placebo-controlled period .


Data were limited to 52 weeks and may not generalize to nonplaque psoriasis .


Apremilast was effective in moderate to severe plaque psoriasis .


To clarify the potential value of second-look laparoscopy ( SLL ) in improving fertility outcomes after laparoscopic salpingostomy for tubal pregnancy .


Randomized controlled trial .


West China Second University Hospital , Sichuan University .


216 women with future birth demand who underwent laparoscopic salpingostomy for tubal pregnancy .


SLL was performed in the SLL group at 3 months after the primary surgery .


In both the SLL and control groups , the subjects were assigned to a slight adhesion ( SLA ) or severe adhesion ( SEA ) subgroup .


At 3-year follow-up , the fertility outcomes were compared between the SLL and control groups and also between the SLA and SEA subgroups .


The intrauterine pregnancy rate was higher in the SLL group compared with the control group ( 63.1 % vs 48.6 % ; p = .032 ) , and the incidence of recurrent ectopic pregnancy was lower in the SLL group than in the control group ( 6.3 % vs 16.2 % ; p = .021 ) .


In the control group , the cumulative pregnancy rate was higher in the SLA subgroup compared with the SEA subgroup ( p = .017 ) , but in the SLL group , the cumulative pregnancy rate did not differ between the 2 subgroups ( p = .502 ) .


The cumulative pregnancy rate was higher in the SEA subgroup of the SLL group compared with the SEA subgroup of the control group ( p = .014 ) , but did not differ between the SLA subgroup of the SLL group and the SLA subgroup of the control group ( p = .456 ) .


SLL may improve subsequent fertility outcome after laparoscopic salpingostomy for tubal pregnancy , and may be especially recommended for women with severe and extensive pelvic adhesions .


Optimum management strategies for patients with advanced non-small-cell lung cancer ( NSCLC ) with acquired resistance to EGFR tyrosine-kinase inhibitors are undefined .


We aimed to assess the efficacy and safety of continuing gefitinib combined with chemotherapy versus chemotherapy alone in patients with EGFR-mutation-positive advanced NSCLC with acquired resistance to first-line gefitinib .


The randomised , phase 3 , multicentre IMPRESS study was done in 71 centres in 11 countries in Europe and the Asia-Pacific region .


Eligible patients were aged at least 18 years with histologically confirmed , chemotherapy-naive , stage IIIB-IV EGFR-mutation-positive advanced NSCLC with previous disease control with first-line gefitinib and recent disease progression ( Response Evaluation Criteria in Solid Tumors version 1.1 ) .


Participants were randomly assigned ( 1:1 ) by central block randomisation to oral gefitinib 250 mg or placebo once daily in tablet form ; randomisation did not include stratification factors .


All patients also received the platinum-based doublet chemotherapy cisplatin 75 mg/m ( 2 ) plus pemetrexed 500 mg/m ( 2 ) on the first day of each cycle .


After completion of a maximum of six chemotherapy cycles , patients continued their randomly assigned treatment until disease progression or another discontinuation criterion was met .


All study investigators and participants were masked to treatment allocation .


The primary endpoint was progression-free survival in the intention-to-treat population .


Safety was assessed in patients who received at least one dose of study treatment .


The study has completed enrolment , but patients are still in follow-up for overall survival .


This trial is registered with ClinicalTrials.gov , number NCT01544179 .


Between March 29 , 2012 , and Dec 20 , 2013 , 265 patients were randomly assigned : 133 to the gefitinib group and 132 to the placebo group .


At the time of data cutoff ( May 5 , 2014 ) , 98 ( 74 % ) patients had disease progression in the gefitinib group compared with 107 ( 81 % ) in the placebo group ( hazard ratio 086 , 95 % CI 065-113 ; p = 027 ; median progression-free survival 54 months in both groups [ 95 % CI 45-57 in the gefitinib group and 46-55 in the placebo group ] ) .


The most common adverse events of any grade were nausea ( 85 [ 64 % ] of 132 patients in the gefitinib group and 81 [ 61 % ] of 132 patients in the placebo group ) and decreased appetite ( 65 [ 49 % ] and 45 [ 34 % ] ) .


The most common adverse events of grade 3 or worse were anaemia ( 11 [ 8 % ] of 132 patients in the gefitinib group and five [ 4 % ] of 132 patients in the placebo group ) and neutropenia ( nine [ 7 % ] and seven [ 5 % ] ) .


37 ( 28 % ) of 132 patients in the gefitinib group and 28 ( 21 % ) of 132 patients in the placebo group reported serious adverse events .


Continuation of gefitinib after radiological disease progression on first-line gefitinib did not prolong progression-free survival in patients who received platinum-based doublet chemotherapy as subsequent line of treatment .


Platinum-based doublet chemotherapy remains the standard of care in this setting .


AstraZeneca .


During endoscopic retrograde cholangiopancreatography ( ERCP ) , a guidewire is used to cannulate biliary strictures and allow for therapeutic interventions .


The aim of this study was to assess the success of stricture cannulation using a combination of a flexible guidewire and a stable nitinol wire vs. a novel , single , stiff-shaft , flexible-tip guidewire .


Consecutive patients who were scheduled for ERCP for biliary obstruction were randomized to undergo the procedure with either a 260-cm long , angled-tip hydrophilic wire in combination with a nitinol wire as required ( standard group ) , or a novel , 270-cm guidewire featuring a hyperflexible , hydrophilic tip with a stiff shaft ( novel group ) .


At unsuccessful negotiation of the stricture , patients in the standard group were switched to the novel guidewire and vice versa ( `` crossover '' ) .


Successful cannulation ( primary success : as assigned ; final success : after `` crossover '' ) , procedure time , and total number of wires needed per procedure were compared .


A total of 222 patients were randomized and 197 were included in the study ( 97 in the standard group and 100 in the novel group ) .


The primary success rate was significantly higher in the novel group ( 94/100 , 94 % ) compared with the standard group ( 77/97 , 79 % ; P = 0.00041 ) , and final success was similar .


Mean time ( median , interquartile range ) to stricture cannulation was 11.2 minutes ( 6.3 , 3.7-14 .6 ) in the standard group and 8.1 minutes ( 2.5 , 0.9-7 .7 ) in the novel group ( P < 0.0001 ) .


The mean total procedure time was 31.2 minutes ( 24.6 , 16.5-40 .8 ) vs. 24.3 minutes ( 16.9 , 10.0-31 .5 ) , respectively ( P = 0.0011 ) .


There were no complications observed with either of the guidewires .


A guidewire that features a flexible tip with a stable shaft could replace the use of a combination of flexible and stable guidewires and increase the success rate of stricture cannulation while decreasing the procedure time.ClinicalTrials.gov Identifier : NCT 01382680 .


Questions enhance learning in Web-based courses , but preliminary evidence suggests that too many questions may interfere with learning .


The authors sought to determine how varying the number of self-assessment questions affects knowledge outcomes in a Web-based course .


The authors conducted a randomized crossover trial in one internal medicine and one family medicine residency program between January 2009 and July 2010 .


Eight Web-based modules on ambulatory medicine topics were developed , with varying numbers of self-assessment questions ( 0 , 1 , 5 , 10 , or 15 ) .


Participants completed modules in four different formats each year , with sequence randomly assigned .


Participants completed a pretest for half their modules .


Outcomes included knowledge , completion time , and module ratings .


One hundred eighty residents provided data .


The mean ( standard error ) percent correct knowledge score was 53.2 ( 0.8 ) for pretests and 73.7 ( 0.5 ) for posttests .


In repeated-measures analysis pooling all data , mean posttest knowledge scores were highest for the 10 - and 15-question formats ( 75.7 [ 1.1 ] and 74.4 [ 1.0 ] , respectively ) and lower for 0 - , 1 - , and 5-question formats ( 73.1 [ 1.3 ] , 72.9 [ 1.0 ] , and 72.8 [ 1.5 ] , respectively ) ; P = .04 for differences across all modules .


Modules with more questions generally took longer to complete and were rated higher , although differences were small .


Residents most often identified 10 questions as ideal .


Posttest knowledge scores were higher for modules that included a pretest ( 75.4 [ 0.9 ] versus 72.2 [ 0.9 ] ; P = .0002 ) .


Increasing the number of self-assessment questions improves learning until a plateau beyond which additional questions do not add value .


Low compliance with training programs is likely to be one of the major reasons for inconsistency of the data regarding the effectiveness of current anterior cruciate ligament ( ACL ) injury prevention programs .


Training methods that reduce training time and cost could favorably influence the effectiveness of ACL injury prevention programs .


A newly designed knee extension constraint training device may serve this purpose .


( 1 ) Knee extension constraint training for 4 weeks would significantly increase the knee flexion angle at the time of peak impact posterior ground-reaction force and decrease peak impact ground-reaction forces during landing of a stop-jump task and a side-cutting task , and ( 2 ) the training effects would be retained 4 weeks after completion of the training program .


Controlled laboratory study .


Twenty-four recreational athletes were randomly assigned to group A or B. Participants in group A played sports without wearing a knee extension constraint device for 4 weeks and then played sports while wearing the device for 4 weeks , while participants in group B underwent a reversed protocol .


Both groups were tested at the beginning of week 1 and at the ends of weeks 4 and 8 without wearing the device .


Knee joint angles were obtained from 3-dimensional videographic data , while ground-reaction forces were measured simultaneously using force plates .


Analyses of variance were performed to determine the training effects and the retention of training effects .


Participants in group A significantly increased knee flexion angles and decreased ground-reaction forces at the end of week 8 ( P .012 ) .


Participants in group B significantly increased knee flexion angles and decreased ground-reaction forces at the ends of weeks 4 and 8 ( P .007 ) .


However , participants in group B decreased knee flexion angles and increased ground-reaction forces at the end of week 8 in comparison with the end of week 4 ( P .009 ) .


Knee extension constraint training for 4 weeks significantly altered lower extremity movement patterns and transferred these changes in lower extremity movement patterns to stop-jump and side-cutting tasks in which ACL injuries frequently occur .


Training effects were retained 4 weeks after the training was completed but were diminished in magnitude .


A knee extension constraint device may be a useful training tool in future ACL injury prevention programs to alter movement patterns without extra training time .


The risk of cardiovascular disease is tremendously high in dialysis patients .


Dialysis patients treated with vitamin D analogs show decreased cardiovascular morbidity and mortality compared with untreated patients .


We examined the influence of two common vitamin D analogs , alfacalcidol and paricalcitol , on important cardiovascular biomarkers in hemodialysis patients .


Anti-inflammatory effects and the influence on regulators of vascular calcification as well as markers of heart failure were examined .


In 57 chronic hemodialysis patients enrolled in a randomized crossover trial comparing paricalcitol and alfacalcidol , we examined the changes in osteoprotegerin , fetuin-A , NT-proBNP , hs-Crp , IL-6 and TNF - , during 16weeks of treatment .


NT-proBNP and osteoprotegerin increased comparably in the paricalcitol and alfacalcidol-treated groups .


Fetuin-A increased significantly in the alfacalcidol-treated group compared with the paricalcitol-treated group ( difference 32.84 mol/l ( 95 % C.I. ; range 0.21-67 .47 ) ) during the first treatment period .


No difference was found between the groups during the second treatment period , and IL-6 , TNF - and hs-Crp were unchanged in both treatment groups .


Paricalcitol and alfacalcidol modulate regulators of vascular calcification .


Alfacalcidol may increase the level of the calcification inhibitor fetuin-A .


We did not find any anti-inflammatory effect or difference in changes of NT-proBNP .


ClinicalTrials.gov NCT00469599 May 3 2007 .


Men with advanced prostate cancer ( APC ) undergoing androgen deprivation therapy ( ADT ) often experience distressing sexual side effects .


Sexual bother is an important component of adjustment .


Factors associated with increased bother are not well understood .


This study sought to describe sexual dysfunction and bother in APC patients undergoing ADT , identify socio-demographic and health/disease-related characteristics related to sexual bother , and evaluate associations between sexual bother and psychosocial well-being and quality of life ( QOL ) .


Baseline data of a larger psychosocial intervention study was used .


Pearson 's correlation and independent samples t-test tested bivariate relations .


Multivariate regression analysis evaluated relations between sexual bother and psychosocial and QOL outcomes .


The Expanded Prostate Cancer Index Composite sexual function and bother subscales , Center for Epidemiologic Studies Depression Scale , Functional Assessment of Cancer Therapy -- General , and Dyadic Adjustment Scale were the main outcome measures .


Participants ( N = 80 ) were 70 years old ( standard deviation [ SD ] = 9.6 ) and reported 18.7 months ( SD = 17.3 ) of ADT .


Sexual dysfunction ( mean = 10.1 ; SD = 18.0 ) was highly prevalent .


Greater sexual bother ( lower scores ) was related to younger age ( = 0.25 , P = 0.03 ) and fewer months of ADT ( = 0.22 , P = 0.05 ) .


Controlling for age , months of ADT , current and precancer sexual function , sexual bother correlated with more depressive symptoms ( = -0.24 , P = 0.06 ) and lower QOL ( = 0.25 , P = 0.05 ) .


Contrary to hypotheses , greater sexual bother was related to greater dyadic satisfaction ( = -0.35 , P = 0.03 ) and cohesion ( = -0.42 , P = 0.01 ) .


The majority of APC patients undergoing ADT will experience sexual dysfunction , but there is variability in their degree of sexual bother .


Psychosocial aspects of sexual functioning should be considered when evaluating men 's adjustment to ADT effects .


Assessment of sexual bother may help identify men at risk for more general distress and lowered QOL .


Psychosocial interventions targeting sexual bother may complement medical treatments for sexual dysfunction and be clinically relevant , particularly for younger men and those first starting ADT .


To investigate the pharmacokinetic/pharmacodynamic ( PK/PD ) interaction between irbesartan ( IRB ) and hydrochlorothiazide ( HCT ) in normotensive subjects .


A three-way crossover study was used .


Serial drug concentrations and drug effects , including systolic and diastolic blood pressure and heart rate were monitored after administration of irbesartan and hydrochlorothiazide alone and in combination .


The data were fitted to a PK/PD model and the parameters for irbesartan and hydrochlorothiazide when administered alone and in combination were compared .


The plasma profiles for irbesartan and hydrochlorothiazide followed the two-compartment model after a single dose .


The PK parameters of irbesartan were not affected by hydrochlorothiazide ; however irbesartan decreased the hydrochlorothiazide AUC by 25 % and increased its clearance by 25 % .


There were no significant changes in heart rate after each drug alone or in combination .


Irbesartan plus hydrochlorothiazide had a greater blood pressure lowering effect compared with irbesartan alone , despite the unchanged irbesartan PK .


The relationship between irbesartan plasma concentration and its effects plotted in chronological order showed anticlockwise hysteresis .


The PD parameter estimates for the effect of irbesartan on systolic blood pressure , when administered with hydrochlorothiazide were significantly different from those when irbesartan was administered alone .


This was manifested by a 25 % increase in Emax , and a 40 % decrease in EC50 , suggesting a synergistic blood pressure lowering effect for the combination .


While parameter estimates for the effect of irbesartan on diastolic blood pressure were changed by hydrochlorothiazide , the differences were only significant for EC50 .


A limited potential for clinically significant interactions between irbesartan and hydrochlorothiazide at the given doses were observed ; therefore , no dosage adjustments were recommended for either drug when used together .


( ClinicalTrials.gov Identifier NCT01858610 )


To investigate a saddle anesthesia with different doses of chloroprocaine in perianal surgery .


Total 60 Patients aged 18-75 years ( Anesthesiologists grade I or II ) scheduled to receive perianal surgery .


Patients using saddle anesthesia were randomized to group A , group B and group C with the same concentration ( 0.5 % ) chloroprocaine with different doses 1.0 mL , 0.8 mL and 0.6 mL , respectively .


Systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , heart rate ( HR ) and the sensory and motor block were recorded to evaluate the anesthesia effect of chloroprocaine in each group .


The duration of sensory block of group C is shorter than those of group A and B.


The maximum degree of motor block is observed ( group C : 0 level , group A : III level ; and group B : I level ) after 15 minutes .


Besides , there was a better anesthetic effect in group B than group A and group C , such as walking after saddle anesthesia .


However , there is also no significant difference of blood pressure decreasing in these three groups .


It 's worth to employ a saddle anesthesia with appropriate doses of chloroprocaine in clinical perianal surgery .


Controlled somatosensory stimulation strategies have demonstrated merit in developing oral feeding skills in premature infants who lack a functional suck , however , the effects of orosensory entrainment stimulation on electrocortical dynamics is unknown .


The objective of the study was to determine the effects of servo-controlled pneumatic orocutaneous stimulation presented during gavage feedings on the modulation of amplitude-integrated electroencephalogram ( aEEG ) and range electroencephalogram ( rEEG ) activity .


Two-channel EEG recordings were collected during 180 sessions that included orocutaneous stimulation and non-stimulation epochs among 22 preterm infants ( mean gestational age = 28.56 weeks ) who were randomized to treatment and control ` sham ' conditions .


The study was initiated at around 32 weeks post-menstrual age .


The raw EEG was transformed into aEEG margins , and rEEG amplitude bands measured at 1-min intervals and subjected to a mixed models statistical analysis .


Multiple significant effects were observed in the processed EEG during and immediately following 3-min periods of orocutaneous stimulation , including modulation of the upper and lower margins of the aEEG , and a reorganization of rEEG with an apparent shift from amplitude bands D and E to band C throughout the 23-min recording period that followed the first stimulus block when compared with the sham condition .


Cortical asymmetry also was apparent in both EEG measures .


Orocutaneous stimulation represents a salient trigeminal input , which has both short - and long-term effects in modulating electrocortical activity , and thus is hypothesized to represent a form of neural adaptation or plasticity that may benefit the preterm infant during this critical period of brain maturation .


Impaired pulmonary gas exchange after cardiac surgeries with cardiopulmonary bypass ( CPB ) often occurs , and the selection of mechanical ventilation mode , pressure-controlled ventilation ( PCV ) or volume-controlled ventilation ( VCV ) , may be important for preventing hypoxia and improving oxygenation .


The authors hypothesized that patients with PCV would show better oxygenation , compared with VCV , during one-lung ventilation ( OLV ) for mitral valve repair surgery ( MVP ) via thoracotomy .


Randomized controlled trial .


University teaching hospital .


Sixty patients in each group .


MVP was performed using thoracotomy with OLV by PCV or VCV .


Arterial partial pressure of oxygen ( PaO2 ) and fraction of inspired oxygen ( FIO2 ) were measured before anesthesia induction ( T0 ) , at skin incision ( T1 ) , after administration of heparin ( T2 ) , at 30 minutes after CPB weaning ( T3 ) , just before departure from the operating room to the intensive care unit ( ICU ) ( T4 ) , and 1 hour after ICU admission ( T5 ) , and PaO2/FIO2 ratio was calculated .


Peak inspiratory pressure ( PIP ) and mean inspiratory pressure ( Pmean ) were recorded at T1 , T2 , T3 , and T4 .


No significant difference was noted in the PaO2/FIO2 ratio between the groups at any measured point .


PIP in the PCV group at all measured points was lower than that in the VCV group ( T1 , p < 0.001 ; T2 , p < 0.001 ; T3 , p < 0.001 ; T4 , p = 0.025 , respectively ) .


Pmean was not different between the two groups at any measured point .


PCV during OLV in patients undergoing MVP via a thoracotomy with OLV showed lower PIP compared with VCV , but this did not improve pulmonary gas exchange .


Currently available disease-modifying treatments acting by modifying the immune response are ineffective in progressive multiple sclerosis ( MS ) , which is caused by a widespread axonal degeneration .


Mechanisms suspected to be involved in this widespread axonal degeneration are reduced axonal energy metabolism , axonal glutamate toxicity , and reduced cerebral blood flow .


Fluoxetine might theoretically reduce axonal degeneration in MS because it stimulates energy metabolism through enhancing glycogenolysis , stimulates the production of brain-derived neurotrophic factor , and dilates cerebral arterioles .


The current document presents the protocol of a clinical trial to test the hypothesis that fluoxetine slows down the progressive phase of MS.


The FLUOX-PMS trial is a multi-center , randomized , controlled and double-blind clinical study .


A total of 120 patients with the diagnosis of either secondary or primary progressive MS will be treated either by fluoxetine ( 40 mg daily ) or placebo for a total period of 108 weeks .


The primary endpoint is the time to confirmed disease progression defined as either at least a 20 % increase in the timed 25-Foot Walk or at least a 20 % increase in the 9-Hole Peg Test .


Secondary endpoints include the Hauser ambulation index , cognitive changes , fatigue , magnetic resonance imaging of the brain , and in a small subgroup optical coherence tomography .


The FLUOX-PMS trial will gives us information as to whether fluoxetine has neuroprotective effects in patients with progressive MS.


Eudra-CT : 2011-003775-11 .


The apolipoprotein A5 gene ( APOA5 ) -1131 T > C polymorphism is associated with mild hypertriglyceridemia in type 2 diabetic subjects , and interacts with dietary fat in the determination of triglyceride concentrations .


We examined whether a substitution of whole grains and legumes for refined rice in a high carbohydrate diet ( about 65 % of energy derived from carbohydrate ) may modify the effect of this variant on changes in apolipoprotein A-V ( apoA-V ) and triglyceride concentrations .


We genotyped the APOA5 -1131 T > C in individuals with impaired fasting glucose ( IFG ) or newly diagnosed type 2 diabetes , who were randomly assigned to either a group ingesting whole grain and legume meals daily or a control group for 12weeks .


After dietary intervention , we observed significant interactions between the APOA5 -1131 T > C polymorphism and carbohydrate sources ( whole grains and legumes versus refined rice ) in the determination of mean percent changes in triglyceride and apoA-V ( P interactions < 0.001 and = 0.038 , respectively ) .


In the refined rice group ( n = 93 ) , the carriers of the risk C allele ( n = 50 ) showed a greater increase in the mean percent changes of triglyceride and apoA-V than noncarriers after adjusting for HOMA-IR ( P = 0.004 and 0.021 , respectively ) .


The whole grain and legume group ( n = 92 ) , however , showed a decrease in fasting glucose , HOMA-IR , and triglyceride , and an increase in apoA-V , irrespective of genotype .


The data showed that the magnitude of the genetic effect of the APOA5 -1131 C variant on triglyceride and apoA-V levels was modulated when substituting consumption of whole grains and legumes for refined rice as a carbohydrate source in IFG or diabetic subjects .


ClinicalTrials.gov : NCT01784952 .


Most patients with facial scarring would value even a slight improvement in scar quality .


Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing .


The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds .


In this double-blinded , randomized , vehicle-controlled , prospective clinical trial , 60 consecutive consenting adults undergoing cleft lip scar revision ( CLSR ) surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A ( n = 30 ) or vehicle ( normal saline ; n = 30 ) injections into the subjacent orbicularis oris muscle immediately after wound closure .


Scars were independently assessed at 6-months follow-up in blinded fashion using : Vancouver Scar Scale ( VSS ) , Visual Analogue Scale ( VAS ) and photographic plus ultrasound measurements of scar widths .


58 patients completed the trial .


All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group .


Quality of surgical upper lip scars , which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle , is significantly improved by its temporary paralysis during wound healing .


ClinicalTrials.gov NCT01429402 .


Evaluate the utility of 2 electronic medical record ( EMR ) - linked , automated phone reminder interventions for improving adherence to cardiovascular disease medications .


A 1-year , parallel arm , pragmatic clinical trial in which 21,752 adults were randomized to receive either usual care ( UC ) or 1 of 2 interventions in the form of interactive voice recognition calls-regular ( IVR ) or enhanced ( IVR + ) .


The interventions used automated phone reminders to increase adherence to cardiovascular disease medications .


The primary outcome was medication adherence ; blood pressure and lipid levels were secondary outcomes .


The study took place in 3 large health maintenance organizations .


We enrolled participants who were 40 years or older , had diabetes mellitus or atherosclerotic cardiovascular disease , and were suboptimally adherent .


IVR participants received automated phone calls when they were due or overdue for a refill .


IVR + participants received these phone calls , plus personalized reminder letters , live outreach calls , EMR-based feedback to their primary care providers , and additional mailed materials .


Both interventions significantly increased adherence to statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers ( ACEIs/ARBs ) compared with UC ( 1.6 to 3.7 percentage points ) .


Adherence to ACEIs/ARBs was also significantly higher for IVR + relative to IVR participants .


These differences persisted across subgroups .


Among statin users , IVR + participants had significantly lower low-density lipoprotein ( LDL ) levels at follow-up compared with UC ( = -1.5 ; 95 % CI , -2.7 to -0.2 mg/dL ) ; this effect was seen mainly in those with baseline LDL levels 100 mg/dL ( = -3.6 ; 95 % CI , -5.9 to -1.3 mg/dL ) .


Technology-based tools , in conjunction with an EMR , can improve adherence to chronic disease medications and measured cardiovascular disease risk factors .


Ischaemia-reperfusion injury following acute myocardial infarctions ( AMI ) is an unavoidable consequence of the primary percutaneous coronary intervention ( pPCI ) procedure .


A pivotal mechanism in ischaemia-reperfusion injury is the production of reactive oxygen species following reperfusion .


The endogenous hormone , melatonin , works as an antioxidant and could potentially minimise the ischaemia-reperfusion injury .


Given intracoronarily , it enables melatonin to work directly at the site of reperfusion .


We wish to test if melatonin , as an antioxidant , can minimise the reperfusion injury following pPCI in patients with AMI .


The IMPACT trial is a multicentre , randomised , double-blinded , placebo-controlled study .


We wish to include 2 20 patients with ST-elevation myocardial infarctions undergoing pPCI within six hours from symptom onset .


The primary end-point is the Myocardial Salvage Index assessed by cardiovascular magnetic resonance imaging on day 4 ( 1 ) after pPCI .


The secondary end-points are high-sensitivity troponin , creatinekinase myocardial band and clinical events .


The aim of the IMPACT trial is to evaluate the effect of melatonin on reperfusion injuries following pPCI .


Owing to its relatively non-toxic profile , melatonin is an easily implementable drug in the clinical setting , and melatonin has the potential to reduce morbidity in patients with AMI .


This study received no financial support from the industry .


www.clinicaltrials.gov , clinical trials identifier : NCT01172171 .


The public typically believes psychotherapy to be more effective than pharmacotherapy for depression treatments .


This is not consistent with current scientific evidence , which shows that both types of treatment are about equally effective .


The study investigates whether this bias towards psychotherapy guides online information search and whether the bias can be reduced by explicitly providing expert information ( in a blog entry ) and by providing tag clouds that implicitly reveal experts ' evaluations .


A total of 174 participants completed a fully automated Web-based study after we invited them via mailing lists .


First , participants read two blog posts by experts that either challenged or supported the bias towards psychotherapy .


Subsequently , participants searched for information about depression treatment in an online environment that provided more experts ' blog posts about the effectiveness of treatments based on alleged research findings .


These blogs were organized in a tag cloud ; both psychotherapy tags and pharmacotherapy tags were popular .


We measured tag and blog post selection , efficacy ratings of the presented treatments , and participants ' treatment recommendation after information search .


Participants demonstrated a clear bias towards psychotherapy ( mean 4.53 , SD 1.99 ) compared to pharmacotherapy ( mean 2.73 , SD 2.41 ; t173 = 7.67 , P < .001 , d = 0.81 ) when rating treatment efficacy prior to the experiment .


Accordingly , participants exhibited biased information search and evaluation .


This bias was significantly reduced , however , when participants were exposed to tag clouds with challenging popular tags .


Participants facing popular tags challenging their bias ( n = 61 ) showed significantly less biased tag selection ( F2 ,168 = 10.61 , P < .001 , partial eta squared = 0.112 ) , blog post selection ( F2 ,168 = 6.55 , P = .002 , partial eta squared = 0.072 ) , and treatment efficacy ratings ( F2 ,168 = 8.48 , P < .001 , partial eta squared = 0.092 ) , compared to bias-supporting tag clouds ( n = 56 ) and balanced tag clouds ( n = 57 ) .


Challenging ( n = 93 ) explicit expert information as presented in blog posts , compared to supporting expert information ( n = 81 ) , decreased the bias in information search with regard to blog post selection ( F1 ,168 = 4.32 , P = .04 , partial eta squared = 0.025 ) .


No significant effects were found for treatment recommendation ( Ps > .33 ) .


We conclude that the psychotherapy bias is most effectively attenuated-and even eliminated-when popular tags implicitly point to blog posts that challenge the widespread view .


Explicit expert information ( in a blog entry ) was less successful in reducing biased information search and evaluation .


Since tag clouds have the potential to counter biased information processing , we recommend their insertion .


Several combined spinal-epidural ( CSE ) anesthesia techniques have been described .


This study was designed to compare the single space ( `` needle-through-needle '' ) technique ( SST ) and the double distant space technique ( DDS ) with regards to the time needed for the procedure , patient discomfort during the procedure and patient 's preference technique .


This prospective , randomized single-blind study included 156 patients undergoing colorectal surgery under general anesthesia and CSE .


All neuraxial blocks were performed before general anesthesia induction .


DDS group of patients had thoracic epidural catheter placed at T6-7 or T7-8 , followed by subarachnoid injection at the L2-3 interspace .


The SST group of patients had a single injection using the needle-through-needle technique ( Espocan needle ) at L2-3 .


The epidural catheter was used for postoperative analgesia for 72 hours .


Body habitus , spinal anatomy and spinal landmarks were assessed preoperatively .


The number of epidural and spinal punctures , the feeling that the dura is perforated ( dural perforation click ) and the time needed to perform CSE were also recorded .


Complications during epidural catheter placement and perioperative and postoperative epidural catheter function and patient preference for the anesthetic procedure were recorded .


Epidural and subarachnoid spaces were successfully identified in all the patients .


Duration of CSE procedure , the number of spinal punctures , dural click feeling and the effects of test dose did not differ between the groups .


The patients in both groups ( 90 % of DDS and 87 % of SST ) would choose CSE as preferred method in the future .


The CSE procedure was painful for 16 % of DDS vs 20 % of SST patients .


A significant correlation between time needed for CSE technique performance and body habitus ( r = 0.338 , p < 0.01 ) , spinal landmarks ( r = 0.452 , p < 0.001 ) and anatomy ( r = 0.265 , p < 0.05 ) was found in the SST group .


There was no correlation between the number of epidural/spinal punctures and epidural bacteriological findings .


There was no correlation between the patients ' choice of the CSE technique and the number of spinal punctures , duration of CSE procedure and epidural catheter stay .


The two CSE techniques did not differ with regards to the procedure time and patient 's preference .


Procedure time correlated with body habitus , spinal landmarks and the anatomy in the SST group .


To assess the effect of analgesia at disbudding on weight gain and milk intake of dairy calves .


Four disbudding protocols were used on 3 - to 6-week-old Friesian-Jersey calves .


Farm staff disbudded 101 calves without sedation or local analgesia , of which 51 received 20mg meloxicam S/C .


Veterinary staff disbudded 101 calves with sedation and local analgesia , of which 51 also received 20mg meloxicam S/C .


Calves were weighed before disbudding , 15 and 30 days later , and individual milk consumption was recorded for 11 days .


Daily weight gain and milk consumption were analysed using mixed models and ANOVA .


From disbudding ( Day 0 ) to Day 15 farmer-disbudded calves receiving meloxicam grew faster ( 0.65 kg/day ) than calves without meloxicam ( 0.55 kg/day ; p = 0.011 ) , but an interaction between operator and meloxicam treatment ( p = 0.056 ) meant that meloxicam treatment did not increase growth rates in veterinary-disbudded calves ( 0.63 vs. 0.64 kg/day ; p = 0.872 ) .


From Days 16-30 there was no significant effect of meloxicam on growth rate , but veterinarian-disbudded calves grew faster ( 0.76 kg/day ) than farmer-disbudded calves ( 0.66 kg/day ; p = 0.034 ) .


Overall , for the first 30 days after disbudding , if meloxicam was not used ' , veterinarian-disbudded calves grew faster than farmer-disbudded calves ( p = 0.002 ) .


However if meloxicam was used at disbudding there was no difference in growth rate between veterinarian - and farmer-disbudded calves ( p = 0.878 ) .


Mean cumulative milk consumption for the 11 days after disbudding was greater for calves disbudded by veterinary staff than by farm staff ( p < 0.001 ) , but there was no effect of meloxicam treatment ( p = 0.618 ) and no interaction with operator ( p = 0.86 ) on cumulative milk consumption .


Three to 6-week-old dairy calves disbudded by farm staff with no analgesia grew significantly slower over the next 15 days than farmer-disbudded calves given meloxicam , and slower over the next 30 days than veterinarian-disbudded calves given xylazine and lignocaine .


However addition of meloxicam to the latter protocol had no effect on growth rate .


Milk intake was significantly higher for 11 days for veterinarian - compared with farmer-disbudded calves .


This study adds to the evidence that analgesia during disbudding is beneficial for calf productivity as well as calf welfare .


The double balloon enteroscopy ( DBE ) procedure is long and requires moderate sedation .


We aim to determine whether the administration of propofol infusion is safe by comparing it to intravenous midazolam/meperidine in patients undergoing DBE .


A prospective study with 48 patients was conducted at King Chulalongkorn Hospital randomizing ( block of four ) patients into two groups .


In group 1 , 28 patients were enrolled for intravenous midazolam/meperidine , and one patient was dropped out before underwent DBE due to hemodynamic instability .


Therefore , 27 ( n = 27 ) participants were included in Group 1 .


In group 2 , 28 patients were enrolled for propofol infusion , and seven patients were dropped out before underwent DBE , five due to hemodynamic instability ( n = 5 ) , and two refused treatment ( n = 2 ) .


Therefore , 1 ( n = 21 ) participants were included in Group 2 .


Vital signs and oxygen saturation were regularly monitored .


Mean + / - SD age of patients was 56.8 + / - 9.2 years , and 41.7 % of patients were male .


There was no difference in demographic data between the groups .


For the safety profile , 25.9 % of the midazolam/meperidine group and 33.3 % of the propofol group developed hypotension and/or desaturation ( p = 0.45 ) .


The patients ' satisfaction of group 1 and group 2 were 86.7 + / - 6.5 % and 86.3 + / - 8.1 % , respectively , and presented no significant difference ( p = 0.89 ) .


Propofol infusion is safe and shows no difference in outcome from the midazolam and meperidine sedation for the DBE procedure .


To evaluate the efficacy of cytoflavin in the treatment of patients with hypertensive encephalopathy ( HE ) .


One hundred and forty patients aged 39 to 73 years , diagnosed with HE , were examined and randomized to 2 groups .


A study group ( n = 74 ) received cytoflavin in a dose of 2 tablets b.i.d. on days 1 to 25 days inclusive during standard basic therapy .


A comparison group ( n = 66 persons ) had standard basic therapy only .


A control group consisted of 30 apparently healthy individuals .


The investigators studied the frequency of headache , dizziness , and other complaints and the intensity of cephalalgic syndrome , by using a visual analog scale , the quality of life by the Medical Outcomes Study 36-Item Short-Form Health Survey ( MOS SF-36 ) questionnaire , that of sleep by the subjective sleep characteristics questionnaire elaborated at the Moscow City Somnological Center , the level of asthenia by a subjective asthenia rating scale ( Multidimensional Fatigue Inventory ( MFI-20 ) , and autonomic status , by applying objective and subjective scales on days 1 and 25 of therapy .


The study has shown that cytoflavin used in the above dose for 25 days reduces the frequency and magnitude of complaints of headache , dizziness , `` venous '' complaints , the degree of autonomic and asthenic disorders , and impairments in the quality of sleep and life in the patients with HE at all disease stages .


A stepwise discriminant analysis has indicated that the degree of cephalgic syndrome , and autonomic disorders , and worse sleep quality are the most effective points for using the energy-modifier cytoflavin .


HE treatment based on the current pathogenetic principles may have a preventive impact on the development of HE or slow down the rate of its progression .


Local failure after radical prostatectomy ( RP ) is common in patients with cancer extending beyond the capsule .


Three prospectively randomized trials demonstrated an advantage for adjuvant radiotherapy ( ART ) compared with a wait-and-see ( WS ) policy .


To determine the efficiency of ART after a 10-yr follow-up in the ARO 96-02 study .


After RP , 388 patients with pT3 pN0 prostate cancer ( PCa ) were randomized to WS or three-dimensional conformal ART with 60 Gy .


The present analysis focuses on intent-to-treat patients who achieved an undetectable prostate-specific antigen after RP ( ITT2 population ) -- that is , 159 WS plus 148 ART men .


The primary end point of the study was progression-free survival ( PFS ) ( events : biochemical recurrence , clinical recurrence , or death ) .


Outcomes were compared by log-rank test .


Cox regression analysis served to identify variables influencing the course of disease .


The median follow-up was 111 mo for ART and 113 mo for WS .


At 10 yr , PFS was 56 % for ART and 35 % for WS ( p < 0.0001 ) .


In pT3b and R1 patients , the rates for WS even dropped to 28 % and 27 % , respectively .


Of all 307 ITT2 patients , 15 died from PCa , and 28 died for other or unknown reasons .


Neither metastasis-free survival nor overall survival was significantly improved by ART .


However , the study was underpowered for these end points .


The worst late sequelae in the ART cohort were one grade 3 and three grade 2 cases of bladder toxicity and two grade 2 cases of rectum toxicity .


No grade 4 events occurred .


Compared with WS , ART reduced the risk of ( biochemical ) progression with a hazard ratio of 0.51 in pT3 PCa .


With only one grade 3 case of late toxicity , ART was safe .


Precautionary radiotherapy counteracts relapse after surgery for prostate cancer with specific risk factors .


The aim of this work was to assess the prognostic value of absolute N-terminal-pro-B-type natriuretic peptide ( NT-proBNP ) concentration in combination with changes during admission because of acute heart failure ( AHF ) and early after hospital discharge .


In AHF , readmission and mortality rates are high .


Identifying those at highest risk for events early after hospital discharge might help to select patients in need of intensive outpatient monitoring .


We evaluated the prognostic value of NT-proBNP concentration on admission , at discharge , 1month after hospital discharge and change over time in 309 patients included in the PRIMA ( Can PRo-brain-natriuretic peptide guided therapy of chronic heart failure IMprove heart fAilure morbidity and mortality ? )


study .


Primary outcome measures were mortality and the combined end point of heart failure ( HF ) readmission or mortality .


In a multivariate Cox regression analysis , change in NT-proBNP concentration during admission , change from discharge to 1month after discharge , and the absolute NT-proBNP concentration at 1 month after discharge were of independent prognostic value for both end points ( hazard ratios for HF readmission or mortality : 1.71 , 95 % confidence interval [ CI ] 1.13-2 .60 , Wald 6.4 [ P = .011 ] versus 2.71 , 95 % CI 1.76-4 .17 , Wald 20.5 [ P < .001 ] versus 1.81 , 95 % CI 1.13-2 .89 , Wald 6.1 [ P = .014 ] , respectively .


Knowledge of change in NT-proBNP concentration during admission because of AHF in combination with change early after discharge and the absolute NT-proBNP concentration at 1 month after discharge allows accurate risk stratification .


Three trials demonstrated recently that a long detection window reduces implantable cardioverter-defibrillator ( ICD ) therapy in primary prevention patients .


Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III ( ADVANCE III ) was the only trial that enrolled both primary and secondary prevention patients .


Of the 1902 patients enrolled in the ADVANCE III trial , 477 received a defibrillator for secondary prevention ; 248 patients were randomly assigned to a long detection setting ( 30 of 40 intervals ) and 229 to the nominal setting ( 18 of 24 intervals ) for ventricular arrhythmias with cycle length 320 ms. Eight-five percent of patients were men , with a mean age of 65 12 years , a previous history of ventricular fibrillation in 37 % of the cases , and a mean ejection fraction of 38 13 % .


The ICD device mix was 37 % single chamber , 47 % dual chamber , and 16 % triple chamber .


Over a median period of 12 months , the long detection period was associated with a 25 % reduction in the number of overall therapies ( 115.6 versus 86.8 per 100 patient-years ; incidence rate ratio , 0.75 ; 95 % confidence interval , 0.61-0 .93 ; P = 0.008 ) and a 34 % reduction in the number of shocks ( rate per 100 patient-years , 51.2 versus 38.1 ; incidence rate ratio , 0.66 ; 95 % confidence interval , 0.48-0 .89 ; P = 0.007 ) .


Appropriate therapies ( 89.7 versus 67.7 ; incidence rate ratio , 0.77 ; 95 % confidence interval , 0.60-0 .97 ; P = 0.029 ) and appropriate shocks ( 37.1 versus 28.1 ; incidence rate ratio , 0.64 ; 95 % confidence interval , 0.45-0 .93 ; P = 0.018 ) were also reduced .


ADVANCE III is the first randomized trial to assess a long detection window setting in ICDs in both primary and secondary prevention populations and demonstrates a reduction of overall therapies and shocks in the subgroup of secondary prevention patients .


These data suggest that even the secondary prevention population may benefit from programming that combines a long detection period with antitachycardia pacing during charging .


http://www/clinicaltrials.gov .


Unique identifier : NCT00617175 .


Prospective , double-blind study , randomized control trial .


To evaluate and compare the analgesic efficacy , adverse effects , and clinical utility of gabapentin and pregabalin in postoperative pain management , long-term functional outcome , and quality of life in patients undergoing spinal surgery .


Patient outcome after lumbar discectomy for radicular low back pain is variable and the benefit is inconsistent .


The most common persistent symptoms are pain , motor deficit , and decreased functional status .


This study was conducted in 90 patients belonging to the 18 to 75 age group of either sex undergoing spinal surgery under general anesthesia .


Group A received 300 mg of gabapentin , group B received 75 mg of pregabalin , whereas group C received placebo 1 dose 1 hour before surgery and 8 hourly for 7 days , thereafter .


The outcome of postoperative static and dynamic pain and functional outcome was recorded using 3 questionnaires-visual analogue scale , Prolo functional and economic score , Oswestry Disability Index score from preoperative period to 3 months postoperatively .


Among the 3 groups , subjects receiving pregabalin showed consistently reduced static and dynamic pain intensity and also required lesser amount of rescue drug throughout the postoperative period .


There was statistically significant difference ( P < 0.05 ) in the Prolo score and Oswestry Disability Index score at all time intervals between group B and group C. Although , significant difference in the functional outcome between group A and group B was seen at 3 months .


Preoperative pregabalin administration is associated with less pain intensity and improved functional outcomes 3 months after lumbar discectomy followed by gabapentin and then placebo .


2 .


Limited data exist regarding the proarrhythmic effects of smoking .


To evaluate the relationship between smoking and the risk of first and recurrent ventricular tachyarrhythmias ( VTAs ) in patients with mild heart failure .


The risk of a first and recurrent appropriate implantable cardioverter-defibrillator therapy for VTAs or death was compared between nonsmokers ( n = 465 ) , past smokers ( n = 780 ) , and current smokers ( n = 197 ) in patients with ischemic and nonischemic cardiomyopathy who were enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy study .


The cumulative probability of a first VTA or death was significantly higher in current smokers than in past and nonsmokers ( P < .001 ) .


Multivariate analysis showed that current smokers had a significantly higher risk of first ventricular tachycardia/ventricular fibrillation or death ( hazard ratio [ HR ] 1.51 ; 95 % confidence interval [ CI ] 1.14-2 .01 ; P = .005 ) and a higher risk for first ventricular tachycardia/ventricular fibrillation episode ( HR 1.54 , 95 % CI 1.12-2 .13 , P = .008 ) than did nonsmokers .


Past smokers had a risk of first VTAs or death similar to that of nonsmokers ( HR 1.01 ; 95 % CI 0.80-1 .27 ; P = .953 ) .


In comparison to nonsmokers , the risk of recurrent VTAs was significantly higher in the total cohort of patients ( HR 1.54 ; 95 % CI 1.21-1 .95 ; P < .001 ) and in the subgroups of patients with ischemic and nonischemic cardiomyopathy ( HR 1.48 ; 95 % CI 1.03-2 .13 ; P = .035 ) .


Current smokers with left ventricular dysfunction and mild heart failure are at a significantly higher risk of VTAs or death than are past smokers and nonsmokers .


Smoking is associated with a significant increase in the risk of recurrent VTAs in both patients with ischemic and nonischemic cardiomyopathy .


Refining leaflet reconstruction has become a primary issue in aortic valve repair .


This descriptive analysis reviews leaflet pathology , repair techniques , and early results in a prospective regulatory trial of aortic valve repair .


Sixty-five patients underwent valve repair for predominant moderate to severe aortic insufficiency ( AI ) .


The mean age was 63 13 years , and 69 % of the patients were male .


Ascending aortic/root replacement was required in 62 % .


As a first step , ring annuloplasty was performed , and then leaflet repair included leaflet plication for prolapse , nodular unfolding , double pericardial patching of commissural defects or holes , complete pericardial leaflet replacement , leaflet extension , and Gore-Tex reinforcement .


Leaflet techniques and causes of adverse outcomes were evaluated .


The follow-up time was 2-years maximal and 0.9 years mean , with a survival of 97 % .


Eighty percent of patients required repair of leaflet defects : leaflet prolapse ( 52/65-80 % ) , ruptured commissures ( 6/65 -9 % ) , leaflet holes ( 4/65 -6 % ) , and nodular retraction ( 6/65 -9 % ) .


The average preoperative AI grade of 2.9 0.8 fell to 0.7 0.7 ( p < 0.0001 ) .


Three patients ( 4.6 % ) required interval valve replacement because of ( 1 ) suture untying , ( 2 ) iatrogenic leaflet tear , or ( 3 ) diphtheroid endocarditis .


Five other patients experienced grade 2 or grade 3 AI : probable suture untying in 1patient , ineffective leaflet extensions in 2 patients , and unsuccessful Gore-Tex reinforcements in2patients .


Two patients with single pericardial leaflet replacements and all those with double pericardial reconstructions did well .


Leaflet defects are common in patients with moderate to severe AI .


Leaflet plication , nodular unfolding , and double pericardial patching performed well .


Gore-Tex and leaflet extension seemed less satisfactory .


Standardization and experience with leaflet reconstruction will be important for optimizing the outcomes of aortic valve repair .


We hypothesize that limited transthoracic echocardiogram ( LTTE ) is a useful tool to guide therapy during the initial phase of resuscitation in trauma patients .


All highest-level alert patients with at least one measurement of systolic blood pressure less than 100 mm Hg , a mean arterial pressure less than 60 mm Hg , and/or a heart rate greater than 120 beats per minute who arrived to the trauma bay ( TB ) were randomized to have either LTTE performed ( LTTEp ) or not performed ( non-LTTE ) as part of their initial evaluation .


Images were stored , and results were reported regarding contractility ( good vs. poor ) , fluid status ( empty inferior vena cava [ hypovolemic ] vs. full inferior vena cava [ not hypovolemic ] ) , and pericardial effusion ( present vs. absent ) .


Time from TB to operating room , intravenous fluid administration , blood product requirement , intensive care unit admission , and mortality were examined in both groups .


A total of 240 patients were randomized .


Twenty-five patients were excluded since they died upon arrival to the TB , leaving 215 patients in the study .


Ninety-two patients were in the LTTEp group with 123 patients in the non-LTTE group .


The LTTEp and non-LTTE groups were similar in age ( 38 years vs. 38.8 years , p = 0.75 ) , Injury Severity Score ( ISS ) ( 19.2 vs. 19.0 , p = 0.94 ) , Revised Trauma Score ( RTS ) ( 5.5 vs. 6.0 , p = 0.09 ) , lactate ( 4.2 vs. 3.6 , p = 0.14 ) , and mechanism of injury ( p = 0.44 ) .


Strikingly , LTTEp had significantly less intravenous fluid than non-LTTE patients ( 1.5 L vs. 2.5 L , p < 0.0001 ) , less time from TB to operating room ( 35.6 minutes vs. 79.1 min , p = 0.0006 ) , higher rate of intensive care unit admission ( 80.4 % vs. 67.2 % , p = 0.04 ) , and a lower mortality rate ( 11 % vs. 19.5 % , p = 0.09 ) .


Mortality differences were particularly evident in the traumatic brain injury patients ( 14.7 % in LTTEp vs. 39.5 % in non-LTTE , p = 0.03 ) .


LTTE is a useful guide for therapy in hypotensive trauma patients during the early phase of resuscitation .


Therapeutic study , level II .


Our goal is to conduct a multicenter randomized controlled trial ( RCT ) to investigate whether exercise can reduce incident fractures compared with no intervention among women aged 65 years with a vertebral fracture .


This pilot study will determine the feasibility of recruitment , retention , and adherence for the proposed trial .


The proposed RCT will be a pilot feasibility study with 1:1 randomization to exercise or attentional control groups .


Five Canadian sites ( 1 community hospital partnered with an academic center and 4 academic hospitals or centers affiliated with an academic center ) and 2 Australian centers ( 1 academic hospital and 1 center for community primary care , geriatric , and rehabilitation services ) .


One hundred sixty women aged 65 years with vertebral fracture at 5 Canadian and 2 Australian centers will be recruited .


The Build Better Bones With Exercise ( B3E ) intervention includes exercise and behavioral counseling , delivered by a physical therapist in 6 home visits over 8 months , and monthly calls ; participants are to exercise 3 times weekly .


Controls will receive equal attention .


Primary outcomes will include recruitment , retention , and adherence .


Adherence to exercise will be assessed via calendar diary .


Secondary outcomes will include physical function ( lower extremity strength , mobility , and balance ) , posture , and falls .


Additional secondary outcomes will include quality of life , pain , fall self-efficacy , behavior change variables , intervention cost , fractures , and adverse events .


Analyses of feasibility objectives will be descriptive or based on estimates with 95 % confidence intervals , where feasibility will be assessed relative to a priori criteria .


Differences in secondary outcomes will be evaluated in intention-to-treat analyses via independent Student t tests , chi-square tests , or logistic regression .


The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall alpha level is .05 .


No assessment of bone mineral density will be conducted .


The proposed definitive trial will require a large sample size .


The viability of a large-scale exercise trial in women with vertebral fractures will be evaluated , as well as the effects of a home exercise program on important secondary outcomes .


Abiraterone acetate , an androgen biosynthesis inhibitor , prolongs survival in men with metastatic castration-resistant prostate cancer ( mCRPC ) in the pre - and post-chemotherapy setting as demonstrated by the pivotal phase III studies COU-AA-301 and COU-AA-302 .


We performed population pharmacokinetic analyses to estimate pharmacokinetic parameters after oral administration of 1,000 mg/day of abiraterone acetate in patients with mCRPC , with or without prior chemotherapy , and after a single 1,000 mg dose in healthy volunteers .


The study objectives were to determine consistency between patient populations and to characterize factors that may influence abiraterone pharmacokinetics .


Studies in this analysis included COU-AA-302 ( chemotherapy nave ) ; COU-AA-301 and COU-AA-006 ( chemotherapy pretreated ) ; and COU-AA-008 , COU-AA-009 , and COU-AA-014 ( healthy subjects ) .


A total of 4,627 plasma concentrations from 359 subjects ( 62 healthy volunteers , 297 patients ) were analyzed using non-linear mixed-effects modeling .


An Erlang-type absorption model with first-order elimination and three-transit compartments following sequential zero - and first-order processes was used to characterize abiraterone pharmacokinetics .


Absorption-related parameters were affected by food intake .


Abiraterone pharmacokinetics were characterized by an extensive apparent clearance , which was lower in patients with mCRPC ( 1,550 L/h ) versus healthy subjects ( 2,240 L/h ) , and by large apparent central ( 5,620 L ) and peripheral ( 17,400 L ) volumes of distribution .


Abiraterone pharmacokinetics were similar in chemotherapy-pretreated and - nave patients and were characterized by a high between - and within-subject variability [ e.g. , between-subject coefficient of variation ( CV % ) for relative bioavailability for the modified fasting state was 61.1 % and the CV % for within-subject variability was 71.3 % ] .


The fat content of food taken with abiraterone acetate affected the bioavailability of abiraterone .


No factors beyond food intake and health status ( healthy vs. mCRPC ) impacted abiraterone pharmacokinetics .


Based on the pharmacokinetics model , the recommended 1,000 mg/day of abiraterone acetate resulted in similar abiraterone exposure for patients with mCRPC regardless of prior chemotherapy .


The fat content of food affected relative bioavailability of abiraterone , though the extent of this effect is dependent on health status .


The appropriate caloric goal for critically ill adults is unclear .


We evaluated the effect of restriction of nonprotein calories ( permissive underfeeding ) , as compared with standard enteral feeding , on 90-day mortality among critically ill adults , with maintenance of the full recommended amount of protein in both groups .


At seven centers , we randomly assigned 894 critically ill adults with a medical , surgical , or trauma admission category to permissive underfeeding ( 40 to 60 % of calculated caloric requirements ) or standard enteral feeding ( 70 to 100 % ) for up to 14 days while maintaining a similar protein intake in the two groups .


The primary outcome was 90-day mortality .


Baseline characteristics were similar in the two groups ; 96.8 % of the patients were receiving mechanical ventilation .


During the intervention period , the permissive-underfeeding group received fewer mean ( SD ) calories than did the standard-feeding group ( 835297 kcal per day vs. 1299467 kcal per day , P < 0.001 ; 4614 % vs. 7122 % of caloric requirements , P < 0.001 ) .


Protein intake was similar in the two groups ( 5724 g per day and 5925 g per day , respectively ; P = 0.29 ) .


The 90-day mortality was similar : 121 of 445 patients ( 27.2 % ) in the permissive-underfeeding group and 127 of 440 patients ( 28.9 % ) in the standard-feeding group died ( relative risk with permissive underfeeding , 0.94 ; 95 % confidence interval [ CI ] , 0.76 to 1.16 ; P = 0.58 ) .


No serious adverse events were reported ; there were no significant between-group differences with respect to feeding intolerance , diarrhea , infections acquired in the intensive care unit ( ICU ) , or ICU or hospital length of stay .


Enteral feeding to deliver a moderate amount of nonprotein calories to critically ill adults was not associated with lower mortality than that associated with planned delivery of a full amount of nonprotein calories .


( Funded by the King Abdullah International Medical Research Center ; PermiT Current Controlled Trials number , ISRCTN68144998 . )


Lobeglitazone , a peroxisome proliferator-activated receptor - agonist , is metabolized primarily by the cytochrome P450 ( CYP ) 3A4 isoenzyme .


Individuals concomitantly taking lobeglitazone and a CYP3A4 inhibitor may experience some adverse effects secondary to increased systemic exposure to lobeglitazone .


To address such potential concern , we evaluated the effects of ketoconazole , a prototypic CYP3A4 inhibitor , on the pharmacokinetic ( PK ) properties and associated adverse effects of lobeglitazone .


A PK drug-drug interaction study was conducted in healthy individuals between 20 and 45 years old in a randomized , open-label , 2-way crossover design .


Even though the PK study was performed on a single dose of lobeglitazone , multiple ketoconazole doses were given to ensure that the full extent of inhibition of CYP3A4 was maintained during the PK sampling .


All study participants received a single oral dose of lobeglitazone 0.5 mg with or without 9 oral 200-mg doses of ketoconazole pretreatment twice daily .


The primary PK parameter end points ( AUC and Cmax ) were estimated using noncompartmental analysis , and the 90 % CIs for the geometric mean ratios ( ratio of lobeglitazone and ketoconazole to lobeglitazone alone ) were investigated .


Tolerability ( adverse events , vital signs , ECG , and laboratory tests ) was also assessed .


A total of 24 Korean men ( mean age , 26 years ; age range , 20-32 years ; mean weight , 68 kg ; weight range , 59-81 kg ) completed the study and were evaluable for lobeglitazone PK properties and tolerability .


The mean ( SD ) Cmax values of lobeglitazone with and without ketoconazole were 49 ( 7 ) ng/mL and 48 ( 6 ) ng/mL at 1.5 and 1.0 hours after dosing , respectively .


The mean ( SD ) AUC values were 532 ( 117 ) ngh/mL and 405 ( 110 ) ngh/mL , respectively .


Although the Cmax was not significantly affected , the geometric mean ratio for AUC was increased by a point estimate of 1.33 ( 90 % CI , 1.23-1 .44 ) .


A single oral administration of lobeglitazone 0.5 mg with or without ketoconazole pretreatment did not produce any clinically significant adverse effects on vital signs , 12-lead ECG profiles , or laboratory tests .


The administration of lobeglitazone , 0.5 mg alone or in combination with multiple doses of ketoconazole , was generally well tolerated .


The systemic exposure of lobeglitazone was increased to a modest extent by pretreatment with 9 twice-daily doses of ketoconazole .


Clinicaltrials.gov identifier : NCT01330563 .


Survivin is a member of the inhibitor-of-apoptosis family .


Essential for tumor cell survival and overexpressed in most cancers , survivin is a promising target for anti-cancer immunotherapy .


Immunogenicity has been demonstrated in multiple cancers .


Nonetheless , few clinical trials have demonstrated survivin-vaccine-induced immune responses .


This phase I trial was conducted to test whether vaccine EMD640744 , a cocktail of five HLA class I-binding survivin peptides in Montanide ( ) ISA 51 VG , promotes anti-survivin T-cell responses in patients with solid cancers .


The primary objective was to compare immunologic efficacy of EMD640744 at doses of 30 , 100 , and 300 g. Secondary objectives included safety , tolerability , and clinical efficacy .


In total , 49 patients who received 2 EMD640744 injections with available baseline - and 1 post-vaccination samples [ immunologic-diagnostic ( ID ) - intention-to-treat ] were analyzed by ELISpot - and peptide/MHC-multimer staining , revealing vaccine-activated peptide-specific T-cell responses in 31 patients ( 63 % ) .


This cohort included the per study protocol relevant ID population for the primary objective , i.e. , T-cell responses by ELISpot in 17 weeks following first vaccination , as well as subjects who discontinued the study before week 17 but showed responses to the treatment .


No dose-dependent effects were observed .


In the majority of patients ( 61 % ) , anti-survivin responses were detected only after vaccination , providing evidence for de novo induction .


Best overall tumor response was stable disease ( 28 % ) .


EMD640744 was well tolerated ; local injection-site reactions constituted the most frequent adverse event .


Vaccination with EMD640744 elicited T-cell responses against survivin peptides in the majority of patients , demonstrating the immunologic efficacy of EMD640744 .


Physiotherapy is integral to modern trauma care .


Early physiotherapy and mobility have been shown to improve outcomes in patients with isolated injuries ; however , the optimal intensity of physiotherapy in the multitrauma patient population has not yet been examined .


The primary aim of this study was to determine whether an intensive physiotherapy program resulted in improved inpatient mobility .


We conducted a single-center prospective randomized controlled study of 90 consecutive patients admitted to the Alfred Hospital ( a Level 1 trauma center ) in Australia between October 2011 and June 2012 who could participate in ward-based physiotherapy .


Participants were allocated to either usual care ( daily physiotherapy treatment , approximately 30 minutes ) or intensive physiotherapy ( usual care plus two additional 30-minute treatments each day ) .


The primary outcome measure was the modified Iowa Level of Assistance ( mILOA ) score , collected by a blinded assessor at Days 3 and 5 ( or earlier if discharged ) .


Secondary measures included physical readiness for discharge , hospital and rehabilitation length of stay , a patient confidence and satisfaction scale , and quality of life at 6 months .


Groups were comparable at baseline .


Participants in the intensive physiotherapy group achieved significantly improved mILOA scores on Day 3 ( median , 7 points compared with 10 points ; p = 0.02 ) and Day 5 ( median , 7.5 points compared with 16 points ; p = 0.04 ) and were more satisfied with their care ( p = 0.01 ) .


There was no difference between groups in time to physical readiness , discharge destination , length of stay , or quality-of-life measures .


Intensive physiotherapy resulted in improved mobility in trauma inpatients .


Further studies are required to determine if specific groups benefit more from intensive physiotherapy and if this translates to long-term improvements in outcomes .


Therapeutic study , level 1 .


Uncertainty may limit communication and affect the ability of patients to adapt to their illness .


A high level of uncertainty in patients concurrent with sudden hearing loss has been related to poor comprehension of communications and poor illness understanding .


Currently , there is no any certain standard information sheet in the clinical setting .


This study evaluates the effect of a one-to-one oral instruction strategy combined with an information sheet firstly on the stimuli frame and then on uncertainty in patients suffering from idiopathic sudden sensorineural hearing loss .


An experimental design was employed and 60 patients were randomly assigned to either the experimental group ( n = 28 ) or the control group ( n = 32 ) .


A structured questionnaire that included the stimuli frame of uncertainty and the Mishel uncertainty illness scale was used to collect data .


All samples received regular care following admission to the hospital and received the pretest within 24 hours after admission .


The experimental group received the one-to-one oral instruction strategy combined with an information sheet immediately after the pretest .


All participants completed the posttest three days later .


The health education program increased perceived understanding of illness in patients with the sudden hearing loss , and reduced their illness uncertainty .


Perceived understanding of illness was negatively related to the level of illness uncertainty .


The stimuli frame of uncertainty acted as a mediator between the intervention and the uncertainty .


The intervention increased the level of cognition of the stimuli frame of uncertainty and then indirectly lowered the uncertainty level .


These findings support the effectiveness of the individual health education strategy with the information sheet in delivering to patients critical information about their condition and treatment .


Moreover , this intervention may effectively increase illness cognition and reduce uncertainty in patients with sudden hearing loss .


Clinical nurse staffs may use the findings of this study to improve their health education efficacy .


Preterm labor and delivery are of the most important complications of pregnancy and have a major role in neonatal mortality and morbidity .


Management of preterm labor and prevention from preterm delivery in order to lower these risks have always been under serious concern .


The purpose of this study was to compare the effect of nifedipine and nitroglycerin ( NG ) dermal patch for taking control of preterm labor .


The study was performed as a randomized clinical trial on women who had been admitted in the hospital diagnosed with preterm labor .


In one group , the NG dermal patch and in the other group , nifedipine was prescribed .


Then the women of the two groups were followed up to delivery and were compared according to arrest of labor for 2h , 48h , 7 days , gestational age at the time of delivery and their adverse effects .


The primary outcome was to postpone delivery for 48h in order to have enough time for prescribing corticosteroids


The women of the two groups did not have any significant difference according to age , body mass index , primary Bishop Score , gestational age at the time of tocolytic therapy , history of abortion , vaginal or cesarean delivery and preterm labor .


In more women in the NG group , delivery was postponed for 2h ( 59 ( 98.3 % ) vs 48 ( 80 % ) , P = 0.001 ) , for 48h ( 52 women ( 86.7 % ) vs 41 ( 68.3 % ) , P = 0.016 ) and also for 7 days ( 47 ( 78.3 % ) vs 37 ( 61.7 % ) , P = 0.046 ) , than the women in the nifedipine group .


Gestational age at the time of delivery was higher in the NG group ( 35.61.9 vs 34.32.05 weeks , P = 0.155 ) , however , it was not statistically significant .


Apgar score of minute 5 , ( P = 0.03 ) and neonatal weight ( P = 0.04 ) , were more and cesarean deliveries , neonatal intensive care unit ( NICU ) admission and duration of NICU stay were less in the NG group .


Adverse effects were similar , minimal and negligible in both groups .


The NG patch is a more effective method for preterm labor control than nifedipine with regard to minimal side effects .


To determine whether incubation in the integrated EmbryoScope time-lapse monitoring system ( TMS ) and selection supported by the use of a multivariable morphokinetic model improve reproductive outcomes in comparison with incubation in a standard incubator ( SI ) embryo culture and selection based exclusively on morphology .


Prospective , randomized , double-blinded , controlled study .


University-affiliated private invitro fertilization ( IVF ) clinic .


Eight hundred forty-three infertile couples undergoing intracytoplasmic sperm injection ( ICSI ) .


No patient intervention ; embryos cultured in SI with development evaluated only by morphology ( control group ) and embryos cultured in TMS with embryo selection was based on a multivariable model ( study group ) .


Rates of embryo implantation , pregnancy , ongoing pregnancy ( OPR ) , and early pregnancy loss .


Analyzing per treated cycle , the ongoing pregnancy rate was statistically significantly increased 51.4 % ( 95 % CI , 46.7-56 .0 ) for the TMS group compared with 41.7 % ( 95 % CI , 36.9-46 .5 ) for the SI group .


For pregnancy rate , differences were not statistically significant at 61.6 % ( 95 % CI , 56.9-66 .0 ) versus 56.3 % ( 95 % CI , 51.4-61 .0 ) .


The results per transfer were similar : statistically significantdifferences in ongoing pregnancy rate of 54.5 % ( 95 % CI , 49.6-59 .2 ) versus 45.3 % ( 95 % CI , 40.3-50 .4 ) and not statisticallysignificantfor pregnancy rate at 65.2 % ( 95 % CI , 60.6-69 .8 ) versus 61.1 % ( 95 % CI , 56.2-66 .1 ) .


Early pregnancy loss wasstatistically significantly decreased for the TMS group with 16.6 % ( 95 % CI , 12.6-21 .4 ) versus 25.8 % ( 95 % CI , 20.6-31 .9 ) .


The implantation rate was statistically significantly increased at 44.9 % ( 95 % CI , 41.4-48 .4 ) versus 37.1 % ( 95 % CI , 33.6-40 .7 ) .


The strategy of culturing and selecting embryos in the integrated EmbryoScope time-lapse monitoring system improves reproductive outcomes .


NCT01549262 .


Once the diagnosis of Helicobacter pylori is confirmed , treatment requires at least two antibiotics and an acid inhibitor for a minimum of seven days .


Unfortunately , treatment failures are being frequently reported .


Treatment regimens that include sequential administration of antibiotics with acid inhibitors have been developed to try and increase the rate of eradication .


To determine the effectiveness of a novel 10-day sequential therapy compared with the standard 10-day triple therapy for treatment of H. pylori infection in children .