While there was no worsening of outcomes for PI across the P-RD spectrum , this occurred in the P-PCI arm ( p ( trend ) = 0.038 ) .


For P-RD 55min , fewer events tended to occur with P-PCI than PI .


Conversely , as P-RD increased to > 55min , PI-assigned patients had better outcomes than P-PCI , suggesting an event-free advantage with PI as P-RD increased ( p ( interaction ) = 0.094 ) .


Analysing P-RD continuously showed that for every 10-min increment there was an increasing trend towards benefit among PI-assigned patients ( p ( interaction ) = 0.073 ) .


As P-RD increased , PI outcomes became superior to P-PCI when P-RD is prolonged and exceeds guideline-mandated times .


In such circumstances , a PI strategy may provide an alternative reperfusion option .


Adverse time delays for delivery of P-PCI should be considered when evaluating reperfusion strategies .


NCT00623623 .


Bleeding after haemorrhoidectomy is common .


Many surgical textbooks recommend insertion of an anal tampon in order to reduce postoperative bleeding .


This practice , however , is bothersome and probably painful for patients .


The effect of using a tamponade has not been validated in randomised controlled trials .


The study included 100 patients who were scheduled for Milligan-Morgan haemorrhoidectomy .


During surgery , patients were randomly assigned to receive or not to receive an anal tampon at the end of the procedure .


Data on pain , complications and wound care were collected .


The trial was registered ( DRKS00003116 ) and all analyses were by intention-to-treat .


There were 48 patients in the group with tamponade , and 52 patients were left without tamponade .


The trial 's primary outcome and maximum pain intensity , averaged 6.1 and 4.2 in the two groups ( P = 0.001 ) .


In the group with tamponade , a complication was recorded in seven patients ( 15 % ) , which was similar to the group without tamponade ( 21 % ) .


Severe anal bleeding occurred in two and five patients , respectively .


Bandage changes were less necessary often in the group treated without tamponade ( P = 0.013 ) .


Hospital stay was 4 days in both groups .


Data indicate that insertion of an anal tampon after haemorrhoidectomy does not reduce postoperative bleeding but causes significantly more pain .


After haemorrhoidectomy , anal tampons should not be used routinely but may be considered when specific indications justify its use .


Acute changes in social belonging are important triggers for alterations in health and well-being , yet research has emphasised the negative effects of ` exclusion ' at the expense of evaluating the potentially positive effects of ` inclusion ' .


This study examined the impact of acute belonging on physiological and psychological outcomes .


A healthy population ( N = 138 ) were randomly allocated to ` included ' or ` excluded ' conditions .


Condition-dependent differences in pre/during-task heart rate and pre/post-task self-reports of negative/positive mood , and social self-esteem , were assessed .


Included participants showed decreased heart rate and negative mood , and increased social self-esteem .


No inclusion-related change in positive mood was shown .


An increase in heart rate was observed in excluded participants though no changes in negative/positive mood or social self-esteem were shown .


Shifts in social self-esteem acted as a mechanism through which inclusion/exclusion impacted upon negative and positive mood alterations .


Results remained significant in presence of covariates ( sex , global self-esteem , rumination and social anxiety ) .


Findings suggest that acting to enhance belonging through ` inclusion ' resulted in adaptive physiological and psychological outcomes .


Neutral and potentially protective responses were observed in the immediate aftermath of ` exclusion ' .


Self-esteem served as one route through which these effects were transmitted .


In sub-Saharan Africa , the burden of human immunodeficiency virus ( HIV ) - associated tuberculosis is high .


We conducted a trial with a 2-by-2 factorial design to assess the benefits of early antiretroviral therapy ( ART ) , 6-month isoniazid preventive therapy ( IPT ) , or both among HIV-infected adults with high CD4 + cell counts in Ivory Coast .


We included participants who had HIV type 1 infection and a CD4 + count of less than 800 cells per cubic millimeter and who met no criteria for starting ART according to World Health Organization ( WHO ) guidelines .


Participants were randomly assigned to one of four treatment groups : deferred ART ( ART initiation according to WHO criteria ) , deferred ART plus IPT , early ART ( immediate ART initiation ) , or early ART plus IPT .


The primary end point was a composite of diseases included in the case definition of the acquired immunodeficiency syndrome ( AIDS ) , non-AIDS-defining cancer , non-AIDS-defining invasive bacterial disease , or death from any cause at 30 months .


We used Cox proportional models to compare outcomes between the deferred-ART and early-ART strategies and between the IPT and no-IPT strategies .


A total of 2056 patients ( 41 % with a baseline CD4 + count of 500 cells per cubic millimeter ) were followed for 4757 patient-years .


A total of 204 primary end-point events were observed ( 3.8 events per 100 person-years ; 95 % confidence interval [ CI ] , 3.3 to 4.4 ) , including 68 in patients with a baseline CD4 + count of at least 500 cells per cubic millimeter ( 3.2 events per 100 person-years ; 95 % CI , 2.4 to 4.0 ) .


Tuberculosis and invasive bacterial diseases accounted for 42 % and 27 % of primary end-point events , respectively .


The risk of death or severe HIV-related illness was lower with early ART than with deferred ART ( adjusted hazard ratio , 0.56 ; 95 % CI , 0.41 to 0.76 ; adjusted hazard ratio among patients with a baseline CD4 + count of 500 cells per cubic millimeter , 0.56 ; 95 % CI , 0.33 to 0.94 ) and lower with IPT than with no IPT ( adjusted hazard ratio , 0.65 ; 95 % CI , 0.48 to 0.88 ; adjusted hazard ratio among patients with a baseline CD4 + count of 500 cells per cubic millimeter , 0.61 ; 95 % CI , 0.36 to 1.01 ) .


The 30-month probability of grade 3 or 4 adverse events did not differ significantly among the strategies .


In this African country , immediate ART and 6 months of IPT independently led to lower rates of severe illness than did deferred ART and no IPT , both overall and among patients with CD4 + counts of at least 500 cells per cubic millimeter .


( Funded by the French National Agency for Research on AIDS and Viral Hepatitis ; TEMPRANO ANRS 12136 ClinicalTrials.gov number , NCT00495651 . )


1 ) To investigate the impact of acetazolamide , a drug commonly prescribed for altitude sickness , on cortical oscillations in patients with obstructive sleep apnea syndrome ( OSAS ) .


2 ) To examine alterations in the sleep EEG after short-term discontinuation of continuous positive airway pressure ( CPAP ) therapy .


Data from two double-blind , placebo-controlled randomized cross-over design studies were analyzed .


Polysomnographic recordings in sleep laboratory at 490 m and at moderate altitudes in the Swiss Alps : 1630 or 1860 m and 2590 m.


Study 1 : 39 OSAS patients .


Study 2 : 41 OSAS patients .


Study 1 : OSAS patients withdrawn from treatment with CPAP .


Study 2 : OSAS patients treated with autoCPAP .


Treatment with acetazolamide ( 500-750 mg ) or placebo at moderate altitudes .


An evening dose of 500 mg acetazolamide reduced slow-wave activity ( SWA ; approximately 10 % ) and increased spindle activity ( approximately 10 % ) during non-REM sleep .


In addition , alpha activity during wake after lights out was increased .


An evening dose of 250 mg did not affect these cortical oscillations .


Discontinuation of CPAP therapy revealed a reduction in SWA ( 5-10 % ) and increase in beta activity ( approximately 25 % ) .


The higher evening dose of 500 mg acetazolamide showed the `` spectral fingerprint '' of Benzodiazepines , while 250 mg acetazolamide had no impact on cortical oscillations .


However , both doses had beneficial effects on oxygen saturation and sleep quality .


Adolescent mothers living with their mothers may be at greater risk of early weaning .


This study aims to assess the influence of a breastfeeding promotion strategy directed at adolescent mothers living with their mothers on the prevalence of breastfeeding in the first year of life .


A randomized clinical trial with 323 adolescent mothers .


Participants were divided into two groups : those who lived with their mothers and those who did not .


Participants were randomly assigned to control or intervention groups .


Intervention consisted of breastfeeding counseling sessions held at the maternity ward and at home ( at 7 , 15 , 30 , 60 , and 120 days postpartum ) .


The intervention effect was assessed by comparing survival curves for breastfeeding in the first 12 months of life .


The risk of weaning before 12 months of age was significantly lower in the intervention group for adolescent mothers not living with their mothers ; whereas the risk was not statistically different between intervention and control groups for those living with their mothers .


The positive influence of systematic counseling sessions on the prevalence of breastfeeding in the first year of life was significant for adolescent mothers .


Living with their mothers reduced such influence .


Rosuvastatin and pitavastatin have been proposed as probe substrates for the organic anion-transporting polypeptide ( OATP ) 1B , but clinical data on their relative sensitivity and selectivity to OATP1B inhibitors are lacking .


A clinical study was therefore conducted to determine their relative suitability as OATP1B probes using single oral ( PO ) and intravenous ( IV ) doses of the OATP1B inhibitor rifampicin , accompanied by a comprehensive in vitro assessment of rifampicin inhibitory potential on statin transporters .


The clinical study comprised of two separate panels of eight healthy subjects .


In each panel , subjects were randomized to receive a single oral dose of rosuvastatin ( 5mg ) or pitavastatin ( 1mg ) administered alone , concomitantly with rifampicin ( 600mg ) PO or IV .


The in vitro transporter studies were performed using hepatocytes and recombinant expression systems .


Rifampicin markedly increased exposures of both statins , with greater differential increases after POvs.IV rifampicin only for rosuvastatin .


The magnitudes of the increases in area under the plasma concentration-time curve were 5.7 - and 7.6-fold for pitavastatin and 4.4 - and 3.3-fold for rosuvastatin , after PO and IV rifampicin , respectively .


In vitro studies showed that rifampicin was an inhibitor of OATP1B1 and OATP1B3 , breast cancer resistance protein and multidrug resistance protein 2 , but not of organic anion transporter 3 .


The results indicate that pitavastatin is a more sensitive and selective and thus preferred clinical OATP1B probe substrate than rosuvastatin , and that a single IV dose of rifampicin is a more selective OATP1B inhibitor than a PO dose .


To evaluate the efficacy of mite allergen specific immunotherapy ( SIT ) to patients of allergic rhinitis .


A total of 102 patients with mite allergy were recruited into the study .


They were randomly divided into two groups : SIT group ( n = 51 ) and ST ( symptomatic therapy ) group ( n = 51 ) .


They were given SIT with standardized allergen vaccine for 3 years or only symptomatic therapy respectively .


Observation items include : rhinitis symptom scores , drug score , skin prick test result , serum specificity IgE ( sIgE ) , peripheral eosinophil counting .


The development of asthma and new allergens sensitization was also assessed .


The blood eosinophil numbers , skin test index , rhinitis symptom scores and drug scores were all decreased significantly after the treatment with SIT for 3 years compared to that of ST group ( P < 0.01 ) .


Although the level of serum slgE was decreased , no statistic diferences were found .


No patients developed asthma in SIT group , and only 2.1 % of patients had new allergen sensitization ; 17.4 % of those in ST group developed asthma , 32.6 % had new sensitization .


No severe adverse events occurred .


Keeping long-term SIT is effective and safe for patients with allergic rhinitis induced by mite , which can also prevent new allergen sensitization and development for asthma .


The ARO 96-02 trial primarily compared wait-and-see ( WS , arm A ) with adjuvant radiation therapy ( ART , arm B ) in prostate cancer patients who achieved an undetectable prostate-specific antigen ( PSA ) after radical prostatectomy ( RP ) .


Here , we report the outcome with up to 12 years of follow-up of patients who retained a post-RP detectable PSA and received salvage radiation therapy ( SRT , arm C ) .


For the study , 388 patients with pT3-4pN0 prostate cancer with positive or negative surgical margins were recruited .


After RP , 307 men achieved an undetectable PSA ( arms A + B ) .


In 78 patients the PSA remained above thresholds ( median 0.6 , range 0.05-5 .6 ng/mL ) .


Of the latter , 74 consented to receive 66 Gy to the prostate bed , and SRT was applied at a median of 86 days after RP .


Clinical relapse-free survival , metastasis-free survival , and overall survival were determined by the Kaplan-Meier method .


Patients with persisting PSA after RP had higher preoperative PSA values , higher tumor stages , higher Gleason scores , and more positive surgical margins than did patients in arms A + B. For the 74 patients , the 10-year clinical relapse-free survival rate was 63 % .


Forty-three men had hormone therapy ; 12 experienced distant metastases ; 23 patients died .


Compared with men who did achieve an undetectable PSA , the arm-C patients fared significantly worse , with a 10-year metastasis-free survival of 67 % versus 83 % and overall survival of 68 % versus 84 % , respectively .


In Cox regression analysis , Gleason score 8 ( hazard ratio [ HR ] 2.8 ) , pT 3c ( HR 2.4 ) , and extraprostatic extension 2 mm ( HR 3.6 ) were unfavorable risk factors of progression .


A persisting PSA after prostatectomy seems to be an important prognosticator of clinical progression for pT3 tumors .


It correlates with a higher rate of distant metastases and with worse overall survival .


A larger prospective study is required to determine which patient subgroups will benefit most from which treatment option .


Knee osteoarthritis ( OA ) , is the most common degenerative joint disease .


Several non-pharmacological interventions have been used for this purpose such as insoles .


There are contradictory data about the superiority and effectiveness of laterally wedged compared with neutrally wedged insoles .


This study was designed to compare the effectiveness of laterally and neutrally wedged insoles in management of knee OA .


In this double-blind , parallel treatment trial , 118 patients with knee OA according to American College of Rheumatology ( ACR ) criteria were enrolled and were followed for 2months .


Patients were randomly divided into two groups .


Fifty-seven of them were treated with 5 laterally elevated wedged insoles ( group A ) and 61 patients were treated with neutrally wedged insoles ( group B ) .


Edinburg Knee Functional Scale ( EKFS ) was used to evaluate knee function before and after interventions .


At the end of 2months , severity of knee pain during the previous 2days , numbers of non-steroid anti inflammatory drugs ( NSAIDs ) used for pain relief within the last 2weeks and EKFS were assessed .


Severity of knee pain decreased in both groups after intervention .


The mean difference in groups A ( laterally wedged insole ) and B ( neutrally wedged insole ) were 29.3 ( 95 % confidence interval [ 95 % CI ] : 25.12 , 33.55 ) and 6.25 ( 95 % CI : 3.09 , 9.4 ) , respectively ( P < 0.001 for both ) .


In addition , at the end of the study , EKFS improved significantly in group A ( mean : 7.54 , 95 % CI : 6.3 , 8.8 ; P < 0.001 ) , while in group B we could not find significant improvement ( mean : 0.54 , 95 % CI : -0.41 , 1.5 ; P = 0.166 ) .


Numbers of NSAIDs used during the two final weeks of the study significantly decreased compared with baseline in group A ( P = 0.001 ; mean : 2.6 , 95 % CI : 1.3 , 3.9 ) ; while in group B this was not shown ( P = 0.9 ; mean : 0.05 , 95 % CI : -0.87 , 0.97 ) .


This study suggests that laterally elevated wedged insoles are more effective than neutrally wedged insoles , in pain relief of knee OA .


A prospective randomized controlled trial .


The purpose of this study was to prospectively compare the efficacy of neurophysiological monitoring during general anesthesia with either a total intravenous technique or with the volatile anesthetic agent , desflurane .


A total intravenous anesthetic technique is generally chosen when neurophysiological monitoring is used as it has been shown to facilitate such monitoring .


Despite this , with prolonged infusions of propofol , prolonged awakening times may be seen , which may impact the time required for postoperative neurological assessment or more importantly result in significant delays , should a wake-up test become necessary .


To date , there are no prospective trials comparing intravenous techniques with a volatile agent-based anesthetic technique and its effects on neurophysiological monitoring .


This prospective study compares somatosensory evoked potential and motor evoked potential monitoring during posterior spinal fusion in 30 adolescents .


The patients were randomized to receive a total intravenous technique with propofol-remifentanil or a volatile agent-based technique with desflurane-remifentanil .


The groups were similar with regard to age , weight , height , body mass index , Cobb angle , and distribution of Lenke classifications .


No differences were noted in anesthesia time , surgery time , intraoperative fluids , or estimated blood loss between the 2 groups .


Time to eye opening , time to following commands , and time to tracheal extubation were shorter in the volatile anesthesia group than the total intravenous anesthesia group .


No clinically significant difference was noted in the amplitude or latency of somatosensory evoked potential monitoring .


Although statistically significantly greater voltage amplitude was required to generate a motor evoked potential , the voltage amount was within a clinically acceptable range .


Our data demonstrate that a volatile agent-based anesthetic regimen is feasible even during neurophysiological monitoring .


Advantages include a more rapid awakening and the feasibility of a rapid wake-up test ( < 5 min ) in the event that irreversible changes in neurophysiological monitoring are noted .


2 .


This randomized trial aimed to evaluate the effects of adding continuous epidural analgesia with a bupivacaine and hydromorphone solution to systemic multimodal analgesia following one - or two-level lumbar spinal fusion .


Thirty-nine patients undergoing lumbar spinal fusion , stratified for sex and one - or two-level fusion , were randomized to receive a continuous postoperative epidural infusion of either 0.1 % bupivacaine with 15gmL ( -1 ) hydromorphone ( LA group ) or 0.9 % saline ( NS group ) at 6mLhr ( -1 ) for 48hr through an epidural catheter placed intraoperatively .


All patients received a standardized postoperative multimodal analgesia regimen .


Patients , healthcare providers , and research staff were blinded .


The primary outcome measure was cumulative opioid consumption ( oral morphine equivalent ) during the first 48hr postoperatively .


The mean ( SD ) cumulative opioid consumption 48hours postoperatively was 249.3 ( 143.3 ) mg in the NS group and 184.7 ( 208.1 ) mg in the LA group ( mean difference 64.6 mg ; 95 % confidence interval -54.3 to 183.5 ; P = 0.27 ) .


There were no adverse events in either group .


Continuous epidural infusion combined with systemic multimodal analgesia resulted in a mean reduction in 48-hr cumulative opioid consumption of 64.6 mg ( 95 % confidence interval -54.3 to 183.5 ) following one - or two-level lumbar spinal fusion .


This estimate of effect is imprecise , and the routine use of continuous epidural analgesia in this surgical population is not yet warranted .


This trial was registered at www.clinicaltrials.gov : NCT00644111 .


To assess the efficacy of massage for decreasing occupational low back pain in workers of a Nursing team in an Emergency Room .


A randomized controlled trial , using a socio-demographic/morbidity questionnaire and a Pain Numeric Scale .


Forty-five subjects were randomly allocated for intervention ( G1 - Massage by acupressure ) , placebo group ( G2 - application of Garlium Arseneid Laser 904 nm turned off ) and control ( G3 - no intervention ) .


The main triggering factor , as well as the worsening of pain , was the patient manipulation , both with a prevalence of 34.9 % .


The main treatment for low back pain before this research was the use of medication , with a prevalence of 44.2 % .


In accordance with a variance analysis , only G1 presented a significant statistical difference , with a better result after 12 sessions .


Massage presented an enormous effect ( d = 4.59 ) , corresponding to 86 % of reduction in the pain level .


Massage was effective to decrease occupational low back pain of those Nursing workers .


Olive oil protects against cardiovascular disease but the underlying mechanism is still unclear .


We speculated that olive oil could inhibitoxidative stress , which is believed to be implicated in the atherosclerotic process .


Post-prandial oxidative stress and endothelial dysfunction were investigated in twenty-five healthy subjects who were randomly allocated in a cross-over design to a Mediterranean diet added with or without extra virgin olive oil ( EVOO , 10g ) ( first study , n = 25 ) or Mediterranean diet with EVOO ( 10g ) or corn oil ( 10g ) ( second study , n = 25 ) .


Oxidative stress biomarkers including platelet reactive oxidant species ( ROS ) and 8-iso-PGF2-III , activity of NOX2 , the catalytic sub-unit of NADPH oxidase , as assessed in platelets and serum , serum vitamin E and endothelial dysfunction , were measured before and 2h after lunch .


In the first study a significant increase of platelet ROS , 8-iso-PGF2-III , NOX2 activity , sE-selectin , sVCAM1 and a decrease of serum vitamin E were detected in controls but not when EVOO was included in the Mediterranean diet ; oxidative stress and endothelial dysfunction increase were also observed in the second study in subjects given corn oil .


A significant correlation was found between NOX2 activity and platelet oxidative stress .


Invitro study demonstrated that EVOO but not corn oil significantly decreased platelet and PMNs oxidative stress and NOX2 activity .


The study provides the first evidence that post-prandial oxidative stress may be triggered by NOX2 up-regulation .


EVOO but not corn oil , is able to counteract such phenomenon suggesting that addition of EVOO to a Mediterranean diet protects against post-prandial oxidative stress .


Persistently poor glycemic control in adult type 1 diabetes patients is a common , complex , and serious problem initiating significant damage to the cardiovascular , renal , neural , and visual systems .


Currently , there is a plethora of low-cost and free diabetes self-management smartphone applications available in online stores .


The aim of this study was to examine the effectiveness of a freely available smartphone application combined with text-message feedback from a certified diabetes educator to improve glycemic control and other diabetes-related outcomes in adult patients with type 1 diabetes in a two-group randomized controlled trial .


Patients were recruited through an online type 1 diabetes support group and letters mailed to adults with type 1 diabetes throughout Australia .


In a 6-month intervention , followed by a three-month follow-up , patients ( n = 72 ) were randomized to usual care ( control group ) or usual care and the use of a smartphone application ( Glucose Buddy ) with weekly text-message feedback from a Certified Diabetes Educator ( intervention group ) .


All outcome measures were collected at baseline and every three months over the study period .


Patients ' glycosylated hemoglobin levels ( HbA1c ) were measured with a blood test and diabetes-related self-efficacy , self-care activities , and quality of life were measured with online questionnaires .


The mean age of patients was 35.20 years ( SD 10.43 ) ( 28 male , 44 female ) , 39 % ( 28/72 ) were male , and patients had been diagnosed with type 1 diabetes for a mean of 18.94 years ( SD 9.66 ) .


Of the initial 72 patients , 53 completed the study ( 25 intervention , 28 control group ) .


The intervention group significantly improved glycemic control ( HbA1c ) from baseline ( mean 9.08 % , SD 1.18 ) to 9-month follow-up ( mean 7.80 % , SD 0.75 ) , compared to the control group ( baseline : mean 8.47 % , SD 0.86 , follow-up : mean 8.58 % , SD 1.16 ) .


No significant change over time was found in either group in relation to self-efficacy , self-care activities , and quality of life .


In adjunct to usual care , the use of a diabetes-related smartphone application combined with weekly text-message support from a health care professional can significantly improve glycemic control in adults with type 1 diabetes .


Australian New Zealand Clinical Trials Registry : ACTRN12612000132842 ; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000132842 ( Archived by WebCite at http://www.webcitation.org/6Kl4jqn5u ) .


Failed intubation may result in both increased morbidity and mortality .


The combination of a video laryngoscope and a flexible tracheoscope used as a flexible video stylet may improve the success rate of securing a difficult airway .


We tested the hypothesis that this combination is a feasible way to facilitate intubation in patients with a predicted difficult airway in that it will shorten intubation times and reduce the number of intubation attempts .


We conducted a randomized , prospective trial in 140 patients with anticipated difficult airways undergoing elective or urgent surgery .


After insertion of video laryngoscope , patients were randomly assigned to either having their tube placed with the use of a preformed stylet ( control group ) or with a flexible tracheoscope ( intervention group ) .


The primary outcome measures were time to successful intubation and number of intubation attempts .


The number of intubations requiring 2 or more intubation attempts was similar in the 2 groups ( 14 % control vs 13 % intervention , P = 1.0 ) ; the number of patients requiring 3 or more intubation attempts was not significantly different ( 8.6 % control vs 1.4 % intervention , P = 0.12 ) .


Distribution for time to intubation also did not differ between the control ( median of 66 seconds , interquartile range 47-89 ) and the intervention group ( median of 71 seconds , interquartile range 52-100 ; P = 0.35 ) .


In the control group , 4 patients , all with cervical spine pathology , had the trachea intubated successfully with the video laryngoscope plus flexible tracheoscope after 3 failed attempts with video laryngoscope and rigid stylet .


For these 4 patients , time from the decision to change the intubation method to successful intubation with a flexible tracheoscope was 36 14 seconds .


Overall success probability for cervical spine patients was 100 % ( 20/20 ) in the intervention group and 80 % ( 16/20 ) in the control group , with an exact 95 % confidence interval for the difference of 1.4 % to 44 % , P = 0.04 .


Flexible tracheoscope-assisted video laryngoscopic intubation is a feasible alternative to video laryngoscope only intubation in patients with predicted difficult airways .


A flexible tracheoscope used in combination with video laryngoscope may also further increase the success rate of intubation in select patients with a proven difficult airway , particularly when in-line stabilization is required .


Hypomethylating agents have demonstrated activity in patients with myelodysplastic syndrome ( MDS ) and acute myeloid leukemia ( AML ) .


Preclinical and single-arm trials have suggested that adding histone deacetylase ( HDAC ) inhibitors may synergize the epigenetic modulation of hypomethylating agents and improve treatment results .


The objective of this study was to evaluate the possible benefit of adding valproic acid , an HDAC inhibitor , to decitabine in the treatment of MDS and AML .


Patients with higher risk MDS or with AML aged 60 years were eligible .


Patients were randomized in a Bayesian response-adaptive design to receive intravenous decitabine 20 mg/m ( 2 ) daily for 5 days or decitabine plus oral valproic acid 50 mg/kg daily for 7 days .


Courses were repeated every 4 to 6 weeks .


A maximum of 150 patients were to be treated .


In total , 149 patients were treated on study , including 87 patients with MDS and 62 patients with AML .


The median patient age was 69 years ( range , 20-89 years ; 42 % of patients were aged 70 years ) .


Overall , 34 % of patients achieved complete remission , and 55 % had an objective response .


The median survival was 11.9 months , and the estimated 2-year survival rate was 27 % .


Outcome was not different with the addition of valproic acid to decitabine versus decitabine alone in relation to the rates of complete remission , overall response , or survival .


Subset analyses did not demonstrate a benefit within the MDS or AML categories .


Toxicities-particularly neurotoxicities-were higher with the combination arm .


Adding valproic acid to decitabine was not associated with improved outcome in the treatment of patients with MDS or elderly patients with AML .


Future therapies may consider combining hypomethylating agents with better HDAC inhibitors and using different schedules .


To compare the effects and short-term outcomes of pressure support ventilation with volume guarantee versus synchronized intermittent mandatory ventilation in the weaning phase of very low-birth weight infants with respiratory distress syndrome .


Randomized controlled prospective study .


Tertiary care neonatal unit .


A total of 60 premature infants who were less than 33 weeks ' gestation and/or less than 1,500 g birth weight and received mechanical ventilation because of respiratory distress syndrome were studied .


All infants were ventilated from the time of admission with synchronized intermittent positive pressure ventilation mode after surfactant treatment for respiratory distress syndrome and then switched to pressure support ventilation with volume guarantee or synchronized intermittent mandatory ventilation mode in the weaning phase .


The ventilatory variables and neonatal outcomes were recorded in each group .


The mean peak inflation pressure was higher in synchronized intermittent mandatory ventilation group ( p < 0.001 ) and the mean airway pressure was higher in pressure support ventilation with volume guarantee group ( p = 0.03 ) , whereas mean tidal volume and respiratory rates were similar in both groups .


The prevalence of postextubation atelectasis was higher in synchronized intermittent mandatory ventilation group , but the difference was not statistically significant ( p = 0.08 ) .


No differences were found in the prevalence of reintubation , patent ductus arteriosus , intraventricular hemorrhage , retinopathy of prematurity , bronchopulmonary dysplasia , and pneumothorax between the groups .


Pressure support ventilation with volume guarantee mode may be a safe and feasible mode during the weaning phase of very low-birth weight infants on mechanical ventilation support for respiratory distress syndrome with respect to reducing the frequency of postextubation atelectasis and using less peak inflation pressure .


To describe the study design and methodology for the p-EVES study , a trial designed to determine the effectiveness , cost-effectiveness and acceptability of portable Electronic Vision Enhancement System ( p-EVES ) devices and conventional optical low vision aids ( LVAs ) for near tasks in people with low vision .


The p-EVES study is a prospective two-arm randomised cross-over trial to test the hypothesis that , in comparison to optical LVAs , p-EVES can be : used for longer duration ; used for a wider range of tasks than a single optical LVA and/or enable users to do tasks that they were not able to do with optical LVAs ; allow faster performance of instrumental activities of daily living ; and allow faster reading .


A total of 100 adult participants with visual impairment are currently being recruited from Manchester Royal Eye Hospital and randomised into either Group 1 ( receiving the two interventions A and B in the order AB ) , or Group 2 ( receiving the two interventions in the order BA ) .


Intervention A is a 2-month period with conventional optical LVAs and a p-EVES device , and intervention B is a 2-month period with conventional optical LVAs only .


The study adopts a mixed methods approach encompassing a broad range of outcome measures .


The results will be obtained from the following primary outcome measures : Manchester Low Vision Questionnaire , capturing device ` usage ' data ( which devices are used , number of times , for what purposes , and for how long ) and the MNRead test , measuring threshold print size , critical print size , and acuity reserve in addition to reading speed at high ( 90 % ) contrast .


Results will also be obtained from a series of secondary outcome measures which include : assessment of timed instrumental activities of daily living and a ` near vision ' visual functioning questionnaire .


A companion qualitative study will permit comparison of results on how , where , and under what circumstances , p-EVES devices and LVAs are used in daily life .


A health economic evaluation will provide results on : the incremental cost-effectiveness of p-EVES compared to optical magnifiers ; cost-effectiveness ; and cost-utility .


The evidence base in low vision rehabilitation is modest and further high quality clinical trials are required to inform decisions on healthcare provision .


The p-EVES study findings are anticipated to contribute to this broader evidence requirement , with the methodological issues evident here being relevant to other trials within the field .


This study sought to determine the utilization and outcomes for radial access for percutaneous coronary intervention ( PCI ) for ST-segment elevation acute myocardial infarction ( STEMI ) in common practice .


Radial access for PCI has been studied considerably , but mostly in clinical trials .


All patients undergoing PCI for STEMI in 2009 to 2010 in New York were studied to determine the frequency and the patient-level predictors of radial access .


Differences in in-hospital/30-day mortality between radial and femoral access were also studied .


Radial access increased from 4.9 % in the first quarter of 2009 to 11.9 % in the last quarter of 2010 .


Significant independent predictors were higher body surface area , non-Hispanic ethnicity , Caucasian race , stable hemodynamic state , ejection fraction < 30 % and 50 % onset of STEMI from 12to 23 h before the index procedure , and peripheral vascular disease .


Mortality was not related to access site after adjustment for covariates ( for radial vs. femoral access , adjusted odds ratio : 0.86 , 95 % confidence interval : 0.59 to 1.25 ) , but the radial access site was trending toward lower mortality for the 9 hospitals that used it for more than 10 % of their patients ( adjusted odds ratio : 0.61 , 95 % confidence interval : 0.36 to 1.02 ) .


The use of a radial access site for PCI in STEMI patients increased between 2009 and 2010 , but was still infrequent in 2010 , and was used for lower-risk STEMI patients .


There was no significant difference in mortality by access site , but there was a trend toward a mortality advantage for patients with a radial access site among hospitals that used it relatively frequently .


A recent study compared the efficacy of tenofovir disoproxil fumarate ( TDF ) vs the combination of emtricitabine and TDF ( FTC/TDF ) in patients with lamivudine-resistant chronic hepatitis B who were treated for as long as 96 weeks .


We report findings from resistance analyses conducted for this study .


Two hundred eighty patients with chronic hepatitis B virus ( HBV ) infection and lamivudine resistance ( confirmed by INNO-LiPA Multi-DR ) were randomly assigned ( 1:1 ) to groups treated with TDF or FTC/TDF .


The HBV reverse transcriptase domain from the polymerase gene from all patients was sequenced at baseline and from 18 viremic patients at week 96 or early discontinuation .


At screening for the efficacy study , 99 % of patients were found to have lamivudine resistance .


Prior exposure to entecavir or entecavir resistance was observed in 12 % of patients , and 22 % of patients had been previously exposed to adefovir ; 1.8 % were resistant to adefovir .


Only 18 patients ( 6.4 % ) qualified for sequence analysis , including 1 patient who experienced virologic breakthrough and 17 with persistent viremia .


Six of these patients did not have any sequence changes from baseline in HBV reverse transcriptase ( 33 % ) , and sequence analysis could not be performed for 5 patients ( 28 % ) .


In 2 patients who qualified for phenotypic analysis ( 1 given TDF and 1 given FTC/TDF ) , no resistance to TDF was observed .


Neither previous treatment exposure nor resistance to entecavir or adefovir affected viral kinetics .


However , the mean baseline level of HBV DNA was significantly higher in viremic patients than in patients with viral suppression by week 96 ( 7.28 log10 IU/mL vs 5.62 log10 IU/mL ; P = .0003 ) .


No resistance to TDF was detected through 96 weeks of treatment in patients with lamivudine-resistant chronic hepatitis B. Prior treatment or resistance to entecavir or adefovir did not affect viral kinetics through 96 weeks .


No additional benefit was observed with the addition of emtricitabine vs TDF monotherapy .


ClinicalTrial.gov number : NCT00737568 .


The impact of educational strategies in the management of adverse treatment effects and drug interactions in adult patients with epilepsy with comorbidities remains undetermined .


The EDU-COM study is a randomised , pragmatic trial investigating the effect of a patient-tailored educational plan in patients with epilepsy with comorbidity .


174 adult patients with epilepsy with chronic comorbidities , multiple-drug therapy and reporting at least one adverse treatment effect and/or drug interaction at study entry were randomly assigned to the educational plan or usual care .


The primary endpoint was the number of patients becoming free from adverse treatment events and/or drug interactions after a 6-month follow-up .


The number of adverse treatment events and drug interactions , health-related quality of life ( HRQOL ) summary score changes and the monetary costs of medical contacts and drugs were assessed as secondary outcomes .


The primary endpoint was met by 44.0 % of patients receiving the educational plan versus 28.9 % of those on usual care ( p = 0.0399 ) .


The control group reported a significantly higher risk not to meet successfully the primary endpoint at the end of the study : OR ( 95 % CI ) of 2.29 ( 1.03 to 5.09 ) .


A separate analysis on drug adverse effects and drug interactions showed that the latter were more sensitive to the effect of educational treatment .


Quality of life and costs were not significantly different in the two groups .


A patient-tailored educational strategy is effective in reducing drug-related problems ( particularly drug interactions ) in epilepsy patients with chronic comorbidities , without adding significant monetary costs .


Registered at ClinicalTrials.gov , identifier NCT01804322 , ( http://www.clinicaltrials.gov ) .


An emerging field of research describes the role of preoperative health behaviours , known as prehabilitation .


The preoperative period may be a more physically and emotionally salient time to introduce and foster chronic adherence to health behaviours , such as exercise , in patients compared to post-treatment during recovery .


Moreover , physical and psychosocial improvements during the preoperative period may translate into an enhanced recovery trajectory with reduced operative complications and postoperative adverse effects .


No studies have assessed prehabilitation for men with prostate cancer undergoing radical prostatectomy .


This is a multi-centre , pilot randomized control trial conducted at two Canadian urban teaching hospitals .


100 men undergoing radical prostatectomy for prostate cancer with no contraindications to exercise will be recruited and randomized to the prehabiliation program or usual care .


Prehabilitation participants will engage in a preoperative , individualized exercise program including pelvic floor muscle strengthening instructions and a healthy lifestyle guide for men with prostate cancer .


These participants will be asked to engage in 60 minutes of home-based , unsupervised , moderate-intensity exercise on 3-4 days per week .


Usual care participants will receive the same pelvic floor muscle strengthening instructions and healthy lifestyle guide only .


We will assess the feasibility of conducting an adequately powered trial of the same design via recruitment rate , programmatic adherence/contamination , attrition , and safety .


Estimates of intervention efficacy will be captured through measurements at baseline ( 4-8 weeks preoperatively ) , within 1 week prior to surgery , and postoperatively at 4 , 12 , and 26 weeks .


Efficacy outcomes include : fatigue , quality of life , urinary incontinence , physical fitness , body composition , aerobic fitness , pain , and physical activity volume .


The primary outcome of this study is to determine the feasibility of conducting a full-scale , randomized controlled trial of prehabilitation versus usual care and to estimate effect sizes that will inform sample size determinations for subsequent trials in this field .


To our knowledge , this is the first study to examine a structured presurgical exercise program for men undergoing radical prostatectomy for prostate cancer .


This trial will advance our understanding of strategies to efficiently and effectively use the preoperative period to optimize postoperative recovery .


Clinicaltrials.gov Identifier : NCT02036684 .


Diabetes mellitus ( DM ) is associated with poor outcome after surgery .


The prevalence of DM in hospitalised patients is up to 40 % , meaning that the anaesthesiologist will encounter a patient with DM in the operating room on a daily basis .


Despite an abundance of published glucose lowering protocols and the known negative outcomes associated with perioperative hyperglycaemia in DM , there is no evidence regarding the optimal intraoperative glucose lowering treatment .


In addition , protocol adherence is usually low and protocol targets are not simply met .


Recently , incretins have been introduced to lower blood glucose .


The main hormone of the incretin system is glucagon-like peptide-1 ( GLP-1 ) .


GLP-1 increases insulin and decreases glucagon secretion in a glucose-dependent manner , resulting in glucose lowering action with a low incidence of hypoglycaemia .


We set out to determine the optimal intraoperative treatment algorithm to lower glucose in patients with DM type 2 undergoing non-cardiac surgery , comparing intraoperative glucose-insulin-potassium infusion ( GIK ) , insulin bolus regimen ( BR ) and GPL-1 ( liragludite , LG ) treatment .


This is a multicentre randomised open label trial in patients with DM type 2 undergoing non-cardiac surgery .


Patients are randomly assigned to one of three study arms ; intraoperative glucose-insulin-potassium infusion ( GIK ) , intraoperative sliding-scale insulin boluses ( BR ) or GPL-1 pre-treatment with liraglutide ( LG ) .


Capillary glucose will be measured every hour .


If necessary , in all study arms glucose will be adjusted with an intravenous bolus of insulin .


Researchers , care givers and patients will not be blinded for the assigned treatment .


The main outcome measure is the difference in median glucose between the three study arms at 1 hour postoperatively .


We will include 315 patients , which gives us a 90 % power to detect a 1 mmol l ( -1 ) difference in glucose between the study arms .


The PILGRIM trial started in January 2014 and will provide relevant information on the perioperative use of GLP-1 agonists and the optimal intraoperative treatment algorithm in patients with diabetes mellitus type 2 .


ClinicalTrials.gov , NCT02036372 .


Pharmacologic treatment for secondary prevention of coronary heart disease ( CHD ) is critical to prevent adverse clinical outcomes .


In a randomized controlled trial , we compared antiplatelet and statin adherence among patients with CHD who received : ( 1 ) text messages ( TM ) for medication reminders and education , ( 2 ) educational TM only , or ( 3 ) No TM .


A mobile health intervention delivered customized TM for 30 days .


We assessed and analyzed medication adherence with electronic monitoring devices [ Medication Event Monitoring System ( MEMS ) ] by one-way ANOVA and Welch tests , two-way TM response rates by t-tests , and self-reported adherence ( Morisky Medication Adherence Scale ) by Repeated Measures ANOVA .


Among 90 patients ( 76 % male , mean age 59.2 years ) , MEMS revealed patients who received TM for antiplatelets had a higher percentage of correct doses taken ( p = 0.02 ) , percentage number of doses taken ( p = 0.01 ) , and percentage of prescribed doses taken on schedule ( p = 0.01 ) .


TM response rates were higher for antiplatelets than statins ( p = 0.005 ) .


Self-reported adherence revealed no significant differences among groups .


TM increased adherence to antiplatelet therapy demonstrated by MEMS and TM responses .


Feasibility and high satisfaction were established .


Mobile health interventions show promise in promoting medication adherence .


To study the impacts of electroacupuncture ( EA ) on memory impairment after cerebral infarction through the observation of hydrogen proton magnetic resonance spectroscopy ( 1H-MRS ) of brain tissue metabolites in the patients of cerebral infarction .


Sixty cases of memory impairment after cerebral infarction were randomized into an observation group and a control group , 30 cases in each one .


The conventional rehabilitation training and medication were applied to all the patients .


In the observation group , beside the basic treatment , EA was applied to bilateral Ezhongxian ( MS 1 ) , Dingzhongxian ( MS 5 ) , Dingniehouxiexian ( MS 7 ) , Hegu ( LI 4 ) , Taichong ( LR 3 ) , Zusanli ( ST 36 ) , Taixi ( KI 3 ) , Xuanzhong ( GB 39 ) and Fengchi ( GB 20 ) .


The treatment was given once a day , 5 times a week , for 8 weeks .


The clinical memory scale was used for the score evaluation before and after treatment in all the patients .


The magnetic resonance image ( MRI ) and 1H-MRS scanning were applied to the head .


The ratio of N-acetyl aspartate ( NAA ) and creatine ( Cr ) and the ratio of choline ( Cho ) and Cr were determined in the foci of cerebral infarction .


Eight weeks later , the scores of clinical memory scale were all increased after treatment as compared with those before treatment in the two group ( all P < 0.01 ) .


The ratio of NAA and Cr was increased as compared with that before treatment ( P < 0.05 ) ; the ratio of Cho and Cr was reduced as compared with that before treatment ( P < 0.05 ) .


The changes in the observation group were more obvious than those in the control group ( all P < 0.05 ) .


On the basis of the conventional medication and rehabilitation training , EA improves the metabolism of brain tissue and memory function of the patients .


The efficacy of this therapy is better than that of medication combined with rehabilitation training .


Vasovagal syncope ( VVS ) represents by far the most common cause of syncope as it is diagnosed in around 50 % of all patients that come to an emergency department .


Although VVS is not fatal , it can cause an injury .


Even serious injuries are not common , but there are reports of serious injuries of up to 5 % .


There are no current studies that demonstrate the effectiveness of any treatment .


Past studies found that an Anti-Gravity suit ( G-suit ) can increase blood pressure and has been reported to prevent orthostatic hypotension effectively in patients with diabetes .


It is possible that the G-suit can prevent VVS .


In the present study , the authors assessed the efficacy of G-suit for vasovagal syncope prevention .


In this open-label , randomized controlled study , we used the Italian tilt protocol , namely 60 degree passive tilting followed by 0.4 mg nitroglycerin challenge when the passive phase fails to induce syncope .


If test was positive , then patient was enrolled .


Tilt table test was repeated to compare G-suited and no G-suited to assess efficacy of G-suit for vasovagal syncope prevention .


10 patients were enrolled .


There is no difference between the control group and an experimental group .


In this study there is no cardio-inhibition vasovagal syncope .


Positive tilt table test occurred in 50 % of the patients receiving G-suited and 100 % in control group ( p 0.133 ) .


G-suit is unable to prevent syncope in patients with positive tilt table test but the result is not statistically significant .


However , the number of patients may be too small .


Hearing-impaired listeners localize sounds better unaided than aided .


Wide dynamic range compression circuits operating independently at each ear in bilateral fittings , and microphone positions of different hearing aid styles , have been cited as a reason .


Two hearing aid features , inter-ear coordinated compression ( IE ) and pinna compensation ( PC ) , were developed to mitigate the compromised aided localization performance .


This study examined the effect of IE and PC on aided localization performance in the horizontal plane with hearing-impaired listeners .


A single-blind , repeated-measures design was used .


A total of 10 experienced hearing aid users with bilaterally symmetrical sensorineural hearing loss who had previously participated in localization training were evaluated .


Localization performance was measured using 12 loudspeakers spaced 30 apart on the horizontal plane .


Aided performance was evaluated using a behind-the-ear hearing aid at four settings : omnidirectional microphone ( Omni ) , Omni microphone with the PC feature , Omni microphone with IE , and Omni microphone with the PC feature and IE together .


In addition , unaided localization performance was measured .


Significant improvement in the localization accuracy was measured for sounds arriving from the back when comparing the PC with the Omni conditions .


The use of IE reduced the magnitude of errors for some listeners for sounds originating from 90 .


The average reduction in the errors was 7.3 .


This study confirmed that the use of the PC feature improved localization for sounds arriving from behind the listener .


The use of IE may improve localization for some listeners for sounds arriving from the sides .


On the Internet , people share personal experiences as well as facts and objective information .


This also holds true for the exchange of health-related information in a variety of Internet forums .


In online discussions about health topics , both fact-oriented and strongly personal contributions occur on a regular basis .


In this field experiment , we examined in what way the particular type of contribution ( ie , factual information vs personal experiences ) has an impact on the subsequent communication in health-related Internet forums .


For this purpose , we posted parallelized queries to 28 comparable Internet forums ; queries were identical with regard to the information contained but included either fact-oriented descriptions or personal experiences related to measles vaccination .


In the factual information condition , we posted queries to the forums that contained the neutral summary of a scientific article .


In the personal experiences condition , we posted queries to the forums that contained the same information as in the first condition , but were framed as personal experiences


We found no evidence that personal experiences evoked more responses ( mean 3.79 , SD 3.91 ) from other members of the Internet forums than fact-oriented contributions ( mean 2.14 , SD 2.93 , t26 = 0.126 , P = .219 ) .


But personal experiences elicited emotional replies ( mean 3.17 , SD 1.29 ) from other users to a greater extent than fact-oriented contributions ( mean 2.13 , SD 1.29 , t81 = 3.659 , P < .001 ) .


We suggest that personal experiences elicited more emotional replies due to the process of emotional anchoring of people 's own style of communication .


We recommend future studies should aim at testing the hypotheses with more general and with less emotionally charged topics , constructing different fact-oriented posts , and examining additional potential factors of influence such as personality factors or particular communication situations .


To test the hypothesis that trained nurse endoscopists are not inferior to medical endoscopists in finding adenomas during colonoscopy .


This is a prospective , randomised , single-blind , non-inferiority study comparing nurses with medical endoscopists in performing screening colonoscopy .


The nurse endoscopists had been trained according to the British Joint Advisory Group on GI Endoscopy curriculum and had completed at least 140 colonoscopic procedures prior to the study .


The primary endpoint was the adenoma detection rate .


Secondary endpoints included the caecal intubation rate , intubation time , complication rate , patient pain and satisfaction scores .


We enrolled and analysed a total of 731 patients over a 15-month period .


At least one adenoma was found in 159 ( 43.8 % ) of 363 patients by nurse endoscopists and 120 ( 32.7 % ) of 367 patients by medical endoscopists and a proportion difference of +11.1 % compared with the medical endoscopists ( 95 % CI 4.1 % to 18.1 % ) .


The withdrawal time was , however , significantly longer among nurses ( 998 vs 575 s , p < 0.001 ) .


After adjusting for differences in a regression analysis , colonoscopy by nurses was associated with a lower adenoma detection rate ( OR 0.475 : 95 % CI 0.311 to 0.725 ) .


Nurse endoscopists had a lower caecal intubation rate ( 97.3 % vs 100 % ) , received better pain and satisfaction scores and had a high rate of patient acceptance .


In this pragmatic trial , nurses can perform screening colonoscopy but require a longer procedural time to achieve a comparable adenoma detection rate as medical endoscopists .


NCT01923155 .


Buprenorphine opioid agonist treatment ( OAT ) has established efficacy for treating opioid dependency among persons seeking addiction treatment .


However , effectiveness for out-of-treatment , hospitalized patients is not known .


To determine whether buprenorphine administration during medical hospitalization and linkage to office-based buprenorphine OAT after discharge increase entry into office-based OAT , increase sustained engagement in OAT , and decrease illicit opioid use at 6 months after hospitalization .


From August 1 , 2009 , through October 31 , 2012 , a total of 663 hospitalized , opioid-dependent patients in a general medical hospital were identified .


Of these , 369 did not meet eligibility criteria .


A total of 145 eligible patients consented to participation in the randomized clinical trial .


Of these , 139 completed the baseline interview and were assigned to the detoxification ( n = 67 ) or linkage ( n = 72 ) group .


Five-day buprenorphine detoxification protocol or buprenorphine induction , intrahospital dose stabilization , and postdischarge transition to maintenance buprenorphine OAT affiliated with the hospital 's primary care clinic ( linkage ) .


Entry and sustained engagement with buprenorphine OAT at 1 , 3 , and 6 months ( medical record verified ) and prior 30-day use of illicit opioids ( self-report ) .


During follow-up , linkage participants were more likely to enter buprenorphine OAT than those in the detoxification group ( 52 [ 72.2 % ] vs 8 [ 11.9 % ] , P < .001 ) .


At 6 months , 12 linkage participants ( 16.7 % ) and 2 detoxification participants ( 3.0 % ) were receiving buprenorphine OAT ( P = .007 ) .


Compared with those in the detoxification group , participants randomized to the linkage group reported less illicit opioid use in the 30 days before the 6-month interview ( incidence rate ratio ,0.60 ; 95 % CI , 0.46-0 .73 ; P < .01 ) in an intent-to-treat analysis .


Compared with an inpatient detoxification protocol , initiation of and linkage to buprenorphine treatment is an effective means for engaging medically hospitalized patients who are not seeking addiction treatment and reduces illicit opioid use 6 months after hospitalization .


However , maintaining engagement in treatment remains a challenge .


clinicaltrials.gov Identifier : NCT00987961 .


Ureteroscopy is central to the surgical management of ureteral stones .


Fluoroscopy is conventionally used for intraoperative guidance , although there is growing effort to decrease the exposure of patients and staff to ionizing radiation .


We developed a radiation-free approach to ureteroscopy using ultrasound guidance to manage ureteral stones .


To our knowledge we present the first randomized trial to study its safety and efficacy .


This single center , randomized clinical trial from 2011 to 2013 enlisted patients who presented with symptomatic ureteral stones 8 mm or less without a significant ipsilateral stone burden .


Patients were randomly assigned to ultrasound or fluoroscopic guided ureteroscopy after temporizing ureteral stent placement .


Intraoperative ultrasound guidance was performed using real-time imaging with the transducer placed at the patient flank to visualize the collecting system of the ipsilateral kidney .


We compared operative time , stone size , stone-free status and complication rates between the 2 groups .


A total of 50 patients were enrolled in study with 25 per arm .


There was no difference in stone size ( 5.9 vs 5.7 mm ) , patient age ( 56 vs 52 years ) or body mass index ( 31 vs 30 kg/m ( 2 ) ) in the test group compared to controls .


The ultrasound guidance cohort showed no significant difference in the stone-free rate ( 86 % vs 86 % ) or the complication rate ( 8 % vs 16 % ) compared to controls .


Operative time was no longer in the ultrasound guidance cohort .


In this feasibility study we found that ureteral stones may be definitively managed in a timely , effective and safe fashion without ionizing radiation in the general population using this novel technique of ultrasound guided ureteroscopy .


Elotuzumab , an immunostimulatory monoclonal antibody targeting signaling lymphocytic activation molecule F7 ( SLAMF7 ) , showed activity in combination with lenalidomide and dexamethasone in a phase 1b-2 study in patients with relapsed or refractory multiple myeloma .


In this phase 3 study , we randomly assigned patients to receive either elotuzumab plus lenalidomide and dexamethasone ( elotuzumab group ) or lenalidomide and dexamethasone alone ( control group ) .


Coprimary end points were progression-free survival and the overall response rate .


Final results for the coprimary end points are reported on the basis of a planned interim analysis of progression-free survival .


Overall , 321 patients were assigned to the elotuzumab group and 325 to the control group .


After a median follow-up of 24.5 months , the rate of progression-free survival at 1 year in the elotuzumab group was 68 % , as compared with 57 % in the control group ; at 2 years , the rates were 41 % and 27 % , respectively .


Median progression-free survival in the elotuzumab group was 19.4 months , versus 14.9 months in the control group ( hazard ratio for progression or death in the elotuzumab group , 0.70 ; 95 % confidence interval , 0.57 to 0.85 ; P < 0.001 ) .


The overall response rate in the elotuzumab group was 79 % , versus 66 % in the control group ( P < 0.001 ) .


Common grade 3 or 4 adverse events in the two groups were lymphocytopenia , neutropenia , fatigue , and pneumonia .


Infusion reactions occurred in 33 patients ( 10 % ) in the elotuzumab group and were grade 1 or 2 in 29 patients .


Patients with relapsed or refractory multiple myeloma who received a combination of elotuzumab , lenalidomide , and dexamethasone had a significant relative reduction of 30 % in the risk of disease progression or death .


( Funded by Bristol-Myers Squibb and AbbVie Biotherapeutics ; ELOQUENT-2 ClinicalTrials.gov number , NCT01239797 . )


Invasive fungal infections are very severe infections associated with high mortality rates , despite the availability of new classes of antifungal agents .


Based on pathophysiological mechanisms and limited pre-clinical and clinical data , adjunctive immune-stimulatory therapy with interferon-gamma ( IFN - ) may represent a promising candidate to improve outcome of invasive fungal infections by enhancing host defence mechanisms .


In this open-label , prospective case series , we describe eight patients with invasive Candida and/or Aspergillus infections who were treated with recombinant IFN - ( rIFN - , 100 g s.c. , thrice a week ) for 2 weeks in addition to standard antifungal therapy .


Recombinant IFN - treatment in patients with invasive Candida and/or Aspergillus infections partially restored immune function , as characterized by an increased HLA-DR expression in those patients with a baseline expression below 50 % , and an enhanced capacity of leukocytes from treated patients to produce proinflammatory cytokines involved in antifungal defence .


The present study provides evidence that adjunctive immunotherapy with IFN - can restore immune function in fungal sepsis patients , warranting future clinical studies to assess its potential clinical benefit .


ClinicalTrials.gov -- NCT01270490 .


To assess the feasibility of using an ultra-low dose ( 0.05 mmol/kg of body weight [ BW ] ) of high relaxivity contrast agent for late gadolinium enhancement ( LGE ) imaging in patients with acute myocardial infarction ( AMI ) .


17 consecutive patients ( mean age , 60.1 10.3 years ) with ST-segment elevation AMI underwent two randomized cardiac magnetic resonance studies ( exam intervals between 24 and 48h ) on a 1.5 T unit during the first week after the event using gadobenate dimeglumine ( Gd-BOPTA ) at the dose of 0.1 mmol/kg BW ( standard dose or SD group ) and 0.05 mmol/kg BW ( half dose or HD group ) .


Image quality was qualitatively assessed .


Quantitative analysis of LGE were performed by measuring signal intensity ( SI ) , signal-to-noise ratio ( SNR ) in the infarcted myocardium ( IM ) , non-infarcted myocardium ( N-IM ) and left ventricular cavity ( LVC ) in images acquired at 1 , 3 , 5 , 10 , 15 and 20 min after administration of Gd-BOPTA using both contrast media protocol .


Contrast-to-noise ratio ( CNR ) between IM and N-IM ( CNR IM/N-IM ) and between IM and LVC ( CNR IM/LVC ) were also quantified for each time point .


Moreover the extent of infarcted myocardium was measured .


102 LGE images were evaluated for each dose group .


Quality score was significantly higher for SD at 1 , 15 and 20 min ( 0.002 < p < 0.046 ) and for HD at 5 min ( p = 0.013 ) .


SNR has been higher in the SD group compared to the HD group even though not statistically significant at any time-point for both IM ( SD vs. HD : 87.7 73 vs. 65 66 ; 0.15 < p < 0.38 ) and N-IM ( SD vs. HD : 22 61 vs. 9.9 6.5 ; 0.09 < p < 0.43 ) .


LVC SNR was significantly higher with SD at 10 min ( p = 0.03 ) , 15 min ( p = 0.001 ) and 20 min ( p = 0.004 ) .


CNR between the IM and N-IM was significantly higher using SD compared to HD ( 1382.24 1049 vs. 695.4 500 ; 0.000 < p < 0.028 ) at 10 , 15 and 20 min .


No significant differences in CNR IM/LVC were noted for HD acquired 5 min after CM administration compared to SD acquired at 10 ( p = 0.34 ) , 15 ( p = 0.96 ) and 20 ( p = 0.41 ) min , and between HD at 10 min compared to SD acquired at 15 min ( p = 0.78 ) and 20 min ( p = 0.32 ) .


Good correlation between SD and HD ( 0.56 < r ( 2 ) < 0.85 , p < 0.024 ) was found at all time-points in the measuring of IA .


The use of a 0.05 mmol/kg dose of gadobenate dimeglumine is feasible for LGE imaging of acute MI and the best image quality is obtained at 5 min after contrast administration .


It could be beneficial in patient with renal failure and a solution to improve the identification of subendocardial infarction reducing examination time , costs and total gadolinium load .


However , the standard dose of 0.1 mmol/kg provides overall better image quality , with the best performance obtained at the delay of 10 min or more after Gd-BOPTA administration , and it should be routinely preferred .


To evaluate the effects of olive oil and flaxseed oil compared with mineral oil for the treatment of constipation in patients undergoing hemodialysis .


A 4-week , double-blind , randomized , and controlled trial was conducted .


Fifty constipated patients ( 29 % male , 5112years ) diagnosed by the Rome III criteria were randomly assigned to receive mineral oil ( control group ; n = 17 ) , olive oil ( n = 16 ) , or flaxseed oil ( n = 17 ) .


The initial oil dose was 4mL/day , and adjustments during the follow-up could be made as needed .


The impact of the intervention was assessed by the Rome III criteria scores .


The most frequent symptoms of constipation evaluated by the Roma III criteria at baseline were comparable among the groups and included `` incomplete evacuation '' ( 92 % ) , `` lumpy or hard stools , '' ( 72 % ) and `` anorectal obstruction '' ( 70 % ) .


The Rome III score improved significantly in patients receiving mineral oil ( 10.55.0 to 4.14.0 ; P < .01 ) , olive oil ( 10.34.2 to 3.23.8 ; P = .01 ) , and flaxseed oil ( 9.64.2 to 6.05.1 ; P < .01 ) , with no significant group-by-time interaction ( P = .15 ) .


The scores of 5 from 6 constipation symptoms reduced similarly in the mineral oil and olive oil groups , whereas only the frequency of evacuation and the consistency of stools improved in the flaxseed oil group .


We demonstrated that the daily use of olive oil or flaxseed oil was as effective as mineral oil in the treatment of constipation in patients undergoing hemodialysis .


The growing prevalence of health care ethics consultation ( HCEC ) services in the U.S. has been accompanied by an increase in calls for accountability and quality assurance , and for the debates surrounding why and how HCEC is evaluated .


The objective of this study was to evaluate the effectiveness of HCEC as indicated by several novel outcome measurements in East Asian medical encounters .


Patients with medical uncertainty or conflict regarding value-laden issues , and requests made by the attending physicians or nurses for HCEC from December 1 , 2009 to April 30 , 2012 were randomly assigned to the usual care group ( UC group ) and the intervention group ( HCEC group ) .


The patients in the HCEC group received HCEC conducted by an individual ethics consultant .


Data analysis was based on the intention-to-treat principle .


Mann-Whitney test and Chi-squared test were used depending on the scale of measurement .


Thirty-three patients ( 53.23 % ) were randomly assigned to the HCEC group and 29 patients were randomly assigned to the UC group .


Among the 33 patients in the HCEC group , two ( 6.06 % ) of them ultimately did not receive a HCEC service .


Among the 29 patients in the UC group , four ( 13.79 % ) of them received a HCEC service .


The survival rate at hospital discharge did not differ between the two groups .


Patients in the HCEC group showed significant reductions in the entire ICU stay and entire hospital stay .


HCEC significantly facilitated achieving the goal of medical care ( p < .01 ) .


Furthermore , patients in the HCEC group had a shorter ICU stay and shorter hospital stay after the occurrence of medical uncertainty or conflict regarding value-laden issues than those in the UC group .


Our findings demonstrated that HCEC were associated with reduced consumption of medical resources as indicated by shorter entire ICU stay , entire hospital stay , and shorter ICU and hospital stay after the occurrence of the medical uncertainty or conflict regarding value-laden issues .


This study also showed that HCEC facilitated achieving a consensus regarding the goal of medical care , which conforms to the goal of HCEC .


The methods of evaluating endoscopic mucosal findings and the definition of mucosal healing in inflammatory bowel disease have not been standardized .


To examine a third-party central review of colonic mucosal evaluations .


A double-blind , placebo-controlled , parallel-group trial was performed for 4weeks , which involved continuous administration of a 1-g mesalazine suppository to 129 patients with mild to moderate ulcerative colitis and active rectal inflammatory findings .


Mucosal findings were evaluated by using a 4-grade score ( 0 , 1 , 2 , 3 ) .


Reviews by attending physicians were considered the primary evaluations .


Concurrently , a central review committee of 7 gastroenterologists served as the third party .


The endoscopic remission induction rate from the attending physicians ' evaluations was 82.8 % in the mesalazine suppository group and 31.1 % in the placebo suppository group , whereas the respective rates from the central review committee were 90.6 % and 59.0 % .


However , there was a difference of 27.9 percentage points between the remission induction rates of the placebo group found by the two groups of raters .


Differences in the evaluations of mucosal finding scores were also found among the third-party reviewers .


The evaluations of the attending physicians were consistent with those of the central review committee in showing the effectiveness of mesalazine suppository through the index of mucosal healing .


However , differences were observed among the raters in their evaluations of mucosal finding scores .


Therefore , standardizing evaluation criteria and improving review methods for mucosal findings would enable the more effective use of third-party central reviews in clinical drug trials .


Poor and underserved women face barriers in receiving timely and appropriate breast cancer care .


Patient navigators help individuals overcome these barriers , but little is known about whether patient navigation improves quality of care .


The purpose of this study is to examine whether navigated women with breast cancer are more likely to receive recommended standard breast cancer care .


Women with breast cancer who participated in the national Patient Navigation Research Program were examined to determine whether the care they received included the following : initiation of antiestrogen therapy in patients with hormone receptor-positive breast cancer ; initiation of postlumpectomy radiation therapy ; and initiation of chemotherapy in women younger than age 70 years with triple-negative tumors more than 1 cm .


This is a secondary analysis of a multicenter quasi-experimental study funded by the National Cancer Institute to evaluate patient navigation .


Multiple logistic regression was performed to compare differences in receipt of care between navigated and non-navigated participants .


Among participants eligible for antiestrogen therapy , navigated participants ( n = 380 ) had a statistically significant higher likelihood of receiving antiestrogen therapy compared with non-navigated controls ( n = 381 ; odds ratio [ OR ] , 1.73 ; P = .004 ) in a multivariable analysis .


Among the participants eligible for radiation therapy after lumpectomy , navigated participants ( n = 255 ) were no more likely to receive radiation ( OR , 1.42 ; P = .22 ) than control participants ( n = 297 ) .


We demonstrate that navigated participants were more likely than non-navigated participants to receive antiestrogen therapy .


Future studies are required to determine the full impact patient navigation may have on ensuring that vulnerable populations receive quality care .


Chemoradioimmunotherapy of patients with pancreatic adenocarcinoma from the CapRI trial did not show any benefit of interferon - in addition to a 5-fluorouracil ( 5FU ) - based treatment .


The aim of this study was to identify immunological parameters in patients from this trial to be used for predictive and/or prognostic purposes .


The following methods were used : tumour immunohistology , FACS analyses , cytokine measurement , as well as cytotoxicity and ELIspot .


Immunological parameters were correlated with patients ' survival using the Kaplan-Meier method .


Irrespective of therapy type , high lymphocyte accumulation in tumours and frequencies of NK cells and effector ( eff ) CD8 ( + ) T cells in peripheral blood of the patients were associated with patients ' survival .


Amount of CD3 ( + ) and effector-memory CD8 ( + ) blood lymphocytes , expression of CD152 and interleukin ( IL ) -2 serum level showed a predictive value for chemoradioimmunotherapy .


Tumoural accumulation of CD3 ( + ) and CD8 ( + ) cells was predictive for outcome of chemotherapy alone .


Besides , we identified the frequencies of CD3 ( + ) lymphocytes , effCD8 ( + ) T cells and NK cells in the peripheral blood of the patients , and IL-10 amount in serum , to be predictive values for 5FU-based chemotherapy .


Immunological parameters , identified in this trial as possible markers , may be of interest in personalized medicine towards the improvement of the treatment and prognosis of pancreatic carcinoma patients .


Patient-specific instrumentation in TKA has the proposed benefits of improving coronal and sagittal alignment and rotation of the components .


In contrast , the literature is inconsistent if the use of patient-specific instrumentation improves alignment in comparison to conventional instrumentation .


Depending on the manufacturer , patient-specific instrumentation is based on either MRI or CT scans .


However , it is unknown whether one patient-specific instrumentation approach is more accurate than the other and if there is a potential benefit in terms of reduction of duration of surgery .


We compared the accuracy of MRI - and CT-based patient-specific instrumentation with conventional instrumentation and with each other in TKAs .


The three approaches also were compared with respect to validated outcomes scores and duration of surgery .


A randomized clinical trial was conducted in which 90 patients were enrolled and divided into three groups : CT-based , MRI-based patient-specific instrumentation , and conventional instrumentation .


The groups were not different regarding age , male/female sex distribution , and BMI .


In all groups , coronal and sagittal alignments were measured on postoperative standing long-leg and lateral radiographs .


Component rotation was measured on CT scans .


Clinical outcomes ( Knee Society and WOMAC scores ) were evaluated preoperatively and at a mean of 3 months postoperatively and the duration of surgery was analyzed for each patient .


MRI - and CT-based patient-specific instrumentation groups were first compared with conventional instrumentation , the patient-specific instrumentation groups were compared with each other , and all three approaches were compared for clinical outcome measures and duration of surgery .


Compared with conventional instrumentation MRI - and CT-based patient-specific instrumentation showed higher accuracy regarding the coronal limb axis ( MRI versus conventional , 1.0 [ range , 0-4 ] versus 4.5 [ range , 0-8 ] , p < 0.001 ; CT versus conventional , 3.0 [ range , 0-5 ] versus 4.5 [ range , 0-8 ] , p = 0.02 ) , femoral rotation ( MRI versus conventional , 1.0 [ range , 0-2 ] versus 4.0 [ range , 1-7 ] , p < 0.001 ; CT versus conventional , 1.0 [ range , 0-2 ] versus 4.0 [ range , 1-7 ] , p < 0.001 ) , and tibial slope ( MRI versus conventional , 1.0 [ range , 0-2 ] versus 3.5 [ range , 1-7 ] , p < 0.001 ; CT versus conventional , 1.0 [ range , 0-2 ] versus 3.5 [ range , 1-7 ] , p < 0.001 ) , but the differences were small .


Furthermore , MRI-based patient-specific instrumentation showed a smaller deviation in the postoperative coronal mechanical limb axis compared with CT-based patient-specific instrumentation ( MRI versus CT , 1.0 [ range , 0-4 ] versus 3.0 [ range , 0-5 ] , p = 0.03 ) , while there was no difference in femoral rotation or tibial slope .


Although there was a significant reduction of the duration of surgery in both patient-specific instrumentation groups in comparison to conventional instrumentation ( MRI versus conventional , 58 minutes [ range , 53-67 minutes ] versus 76 minutes [ range , 57-83 minutes ] , p < 0.001 ; CT versus conventional , 63 minutes [ range , 59-69 minutes ] versus 76 minutes [ range , 57-83 minutes ] , p < .001 ) , there were no differences in the postoperative Knee Society pain and function and WOMAC scores among the groups .


Although this study supports that patient-specific instrumentation increased accuracy compared with conventional instrumentation and that MRI-based patient-specific instrumentation is more accurate compared with CT-based patient-specific instrumentation regarding coronal mechanical limb axis , differences are only subtle and of questionable clinical relevance .


Because there are no differences in the long-term clinical outcome or survivorship yet available , the widespread use of this technique can not be recommended .


To determine whether Zinc supplementation could reduce relapse rate in children with nephrotic syndrome .


Randomized-controlled trial .


National Institute of Child-Health and The Kidney Centre , Karachi , from January 2008 to June 2009 .


Sixty nephrotic children aged 2 - 15 years were selected .


Baseline data including age , number of infections and relapses during pre and post study one year were recorded .


Randomization was done to divide into Zinc group ( Zg ) to receive Zinc versus placebo ( Pg ) for 6 months .


Relapses and infections were treated with standard therapy .


T-test and chi-square tests were used to compare the mean values and proportions respectively with significance at p < 0.05 .


Among 60 children , 54 completed trial ( Zg = 25 , Pg = 29 ) .


Forty ( 74 % ) were males and 14 ( 26 % ) females .


Mean age , pre study relapses and Zinc level in the two groups were similar .


Overall , infections and relapses were observed in 43 ( 79.62 % ) and 17 cases ( 31.48 % ) respectively .


There was no significant difference in frequency of infections and mean infection rate in Zg ( 20 , 80 % and 1.92 1.47 ) compared to Pg ( 23 , 79.3 % and 2 1.53 , p = 0.950 ) .


Relapses occurred in 7 ( 28 % ) in Zg compared to 10 ( 34 % ) in Pg which was not significant ( p = 0.609 ) .


Mean infection and relapse rate per patient per year ( PPPY ) in Zg was 1.92 1.47 and 1.14 0.37 compared to 2 1.53 and1 .3 0.48 in Pg respectively ( p = 0.846 , 0.464 ) .


Pre study relapses in two groups were similar ( Zg vs. Pg = 96 vs. 96.6 % ) whereas post study relapses in Zg were lower ( 7 , 28 % ) compared to Pg ( 10 , 34.5 % ) .


Post study mean relapse rate in Zg was 1.14 0.37 PPPY compared to 2.71 1.11 in pre study ( p = 0.005 ) .


In Pg , post study mean relapse rate PPPY was 1.30 0.48 compared to 1.70 0.48 in pre study period ( p = 0.037 ) .


Relapse rate reduction was 43 % after Zinc supplementation compared to 27 % reduction in placebo .


Metallic taste was observed in 10 % of cases .


Zinc supplementation was helpful in reducing relapses in nephrotic syndrome .


To compare two systems of arterial catheters maintenance in postoperative pediatric surgery using intermittent or continuous infusion of heparin solution and to analyze adverse events related to the site of catheter insertion and the volume of infused heparin solution .


Randomized control trial with 140 patients selected for continuous infusion group ( CIG ) and intermittent infusion group ( IIG ) .


The variables analyzed were : type of heart disease , permanence time and size of the catheter , insertion site , technique used , volume of heparin solution and adverse events .


The descriptive variables were analyzed by Student 's t-test and the categorical variables , by chi-square test , being significant p < 0.05 .


The median age was 11 ( 0-22 ) months , and 77 ( 55 % ) were females .


No significant differences between studied variables were found , except for the volume used in CIG ( 12.01.2 mL/24 hours ) when compared to IIG ( 5.33.5 mL/24 hours ) with p < 0.0003 .


The continuous infusion system and the intermittent infusion of heparin solution can be used for intra-arterial catheters maintenance in postoperative pediatric surgery , regardless of patient 's clinical and demographic characteristics .


Adverse events up to the third postoperative day occurred similarly in both groups .


However , the intermittent infusion system usage in underweight children should be considered , due to the lower volume of infused heparin solution [ ClinicalTrials.gov Identifier : NCT01097031 ] .


In the double-blind placebo-controlled Fenofibrate Intervention and Event Lowering in Diabetes trial ( n = 9,795 ) , fenofibrate reduced major cardiovascular events in type 2 diabetes .


Sex-related differences in fenofibrate response could be clinically relevant and were pre-specified analyses .


Women ( n = 3,657 ) and men ( n = 6,138 ) with type 2 diabetes not using statins were assigned fenofibrate ( 200mg/day ) or placebo for 5years .


Effects on lipoproteins and total cardiovascular events were evaluated by sex .


Baseline total , LDL - , HDL - and non-HDL cholesterol and apolipoproteins A-I and B differed between sexes , and these and triacylglycerol levels improved with fenofibrate in both sexes ( all p < 0.001 ) .


Fenofibrate reduced total , LDL - and non-HDL cholesterol and apolipoprotein B more in women ( all p < 0.001 ) , independent of menopausal status and statin uptake .


Adjusted for covariates , fenofibrate reduced total cardiovascular outcomes ( cardiovascular death , fatal and non-fatal stroke and carotid and coronary revascularisation ) by 30 % in women ( 95 % CI 8 % , 46 % ; p = 0.008 ) and 13 % in men ( 95 % CI -1 % , 24 % ; p = 0.07 ) with no treatment-by-sex interaction ( p > 0.1 ) .


In patients with high triacylglycerol levels and low HDL-cholesterol , fenofibrate reduced total cardiovascular outcomes by 30 % ( 95 % CI -7 % , 54 % ) in women and 24 % ( 95 % CI 2 % , 42 % ) in men , with no treatment-by-sex interaction ( p > 0.1 ) .


Fenofibrate improved the lipoprotein profile more in women than men .


Cardiovascular event reductions with fenofibrate were consistently similar in women and men , both overall and among those with low HDL-cholesterol and high triacylglycerol levels .


These data provide reassurance about fenofibrate efficacy in women and men .


Both sexes with type 2 diabetes should be considered for fenofibrate therapy for cardioprotection .


We aimed to determine with this randomized , triple-masked , placebo-controlled study if benefits are afforded by adding a multiple-day , ambulatory , continuous ropivacaine paravertebral nerve block to a single-injection ropivacaine paravertebral block after mastectomy .


Preoperatively , 60 subjects undergoing unilateral ( n = 24 ) or bilateral ( n = 36 ) mastectomy received either unilateral or bilateral paravertebral perineural catheter ( s ) , respectively , inserted between the third and fourth thoracic transverse process ( es ) .


All subjects received an initial bolus of ropivacaine 0.5 % ( 15 mL ) via the catheter ( s ) .


Subjects were randomized to receive either perineural ropivacaine 0.4 % or normal saline using portable infusion pump ( s ) [ 5 mL/h basal ; 300 mL reservoir ( s ) ] .


Subjects remained hospitalized for at least 1 night and were subsequently discharged home where the catheter ( s ) were removed on postoperative day ( POD ) 3 .


Subjects were contacted by telephone on PODs 1 , 4 , 8 , and 28 .


The primary end point was average pain ( scale , 0-10 ) queried on POD 1 .


Average pain queried on POD 1 for subjects receiving perineural ropivacaine ( n = 30 ) was a median ( interquartile ) of 2 ( 0-3 ) , compared with 4 ( 1-5 ) for subjects receiving saline ( n = 30 ; 95 % confidence interval difference in medians , -4.0 to -0.3 ; P = 0.021 ] .


During this same period , subjects receiving ropivacaine experienced a lower severity of breakthrough pain ( 5 [ 3-6 ] vs 7 [ 5-8 ] ; P = 0.046 ) as well .


As a result , subjects receiving perineural ropivacaine experienced less pain-induced physical and emotional dysfunction , as measured with the Brief Pain Inventory ( lower score = less dysfunction ) : 14 ( 4-37 ) versus 57 ( 8-67 ) for subjects receiving perineural saline ( P = 0.012 ) .


For the subscale that measures the degree of interference of pain on 7 domains , such as general activity and relationships , subjects receiving perineural saline reported a median score 10 times higher ( more dysfunction ) than those receiving ropivacaine ( 3 [ 0-24 ] vs 33 [ 0-44 ] ; P = 0.035 ) .


In contrast , after infusion discontinuation , there were no statistically significant differences detected between treatment groups .


After mastectomy , adding a multiple-day , ambulatory , continuous ropivacaine infusion to a single-injection ropivacaine paravertebral nerve block results in improved analgesia and less functional deficit during the infusion .


However , no benefits were identified after infusion discontinuation .


We hypothesised that short-term application of bi-level nasal continuous positive airway pressure CPAP ( SiPAP ) compared with conventional nasal CPAP ( nCPAP ) at the same mean airway pressure in infants with persistent oxygen need recovering from respiratory distress syndrome would improve CO2 removal with no change in oxygen requirement .


Non-blinded , randomised , observational four-period crossover study .


Level III NICU ; low-birthweight infants requiring CPAP and oxygen while recovering from respiratory distress syndrome .


Infants requiring nasal CPAP for > 24h prior to study enrolment , and fraction of inspired oxygen requirement ( FiO2 ) of 0.25-0 .5 , were randomised to either nCPAP or SiPAP .


A crossover design with four 1 h treatment periods was used such that each infant received both treatments twice .


Oxygen saturations ( SaO2 ) , transcutaneous CO2 ( tcCO2 ) and vital signs were monitored continuously .


Polysomnographic recordings were analysed for apnoea , bradycardia and oxygen desaturation .


Twenty low-birthweight infants receiving 0.30.04 % supplemental oxygen on CPAP of 6 cm H2O were studied at an average of 33days of age ( 23days , SD ) .


There were no differences in tcCO2 or other physiological parameters except mean blood pressure , which was lower during nCPAP ( 52.38.3 vs 54.49.1 mmHg ; SD ; p < 0.01 ) .


No differences in short or prolonged apnoea , bradycardia or significant desaturation events were observed .


At similar mean airway pressures , SiPAP does not improve CO2 removal , oxygenation or other studied physiological parameters with the exception of mean blood pressure , which was not clinically significant .


NCT01053455 .


Our goal was to develop and validate , based on theoretical and empirical knowledge , the Pain Assessment Checklist for Seniors with Limited Ability to Communicate ( PACSLAC-II ) , a shorter tool that would improve on the PACSLAC , while addressing limitations of the original version .


The PACSLAC was revised based on the relevant clinical and theoretical literature .


Psychometric properties and clinical utility of the resulting 31-item PACSLAC-II were examined .


Specifically , the PACSLAC-II was used to assess pain based on video footage of long-term care ( LTC ) residents with dementia undergoing painful procedures as part of routine care .


Its ability to discriminate pain from non-pain-related states was compared with that of preexisting pain assessment tools using archival data .


A second phase involved the use of the PACSLAC and PACSLAC-II by LTC staff to solicit feedback from health care providers .


Mixed-methods analysis of this feedback was conducted .


The PACSLAC-II demonstrated satisfactory reliability , excellent validity , and ability to differentiate between pain and nonpain states .


The PACSLAC-II also accounted for unique variance in differentiating between pain and nonpain states , even after controlling for the preexisting tools combined , including the PACSLAC .


The PACSLAC-II was also preferred by many LTC nurses and care aides , because of its length and condensed nature , which was thought to facilitate documentation and greater efficiency in pain management .


Findings indicate that the empirical and theoretically driven revisions to the PACSLAC led to improved ability to differentiate between pain and nonpain states , while retaining its clinical utility .


The lipid layer plays a major role in limiting evaporation of the tear film .


Based on interference phenomena , there is a test directed to lipid layer pattern ( LLP ) evaluation , but is affected by subjective interpretation of the patterns .


The aim of this study is to compare the LLP evaluation between two experienced observers on a group of healthy patients .


Furthermore , observers re-evaluated the same images to check their individual repeatability .


LLP was examined using a Tearscope-plus ( Keeler , Windsor , UK ) attached to a slit lamp .


Tear film was recorded by a Topcon DV-3 digital camera video and LLP images were captured .


This yielded 124 LLP images that were categorized ( based on Guillon 's scheme ) by two expert observers in two sessions separated by one month .


Interobserver repeatability and intraobserver repeatability between both sessions were studied by using Cohen 's kappa coefficient .


Comparing LLP categorization between both observers , Cohen 's kappa coefficient was 0.615 and 0.633 for first and second session , respectively .


When comparing LLP categorization by the same observer between both sessions , Cohen 's kappa coefficient was 0.770 and 0.812 for Observer 1 and Observer 2 , respectively .


These results indicate substantial correlation in all cases .


The most frequent misinterpretations were between open and closed meshwork and Wave and closed meshwork patterns .


Although substantial correlation was found between categorizations of experienced observers , misinterpretation of the patterns may appear even in the same observer .


Some misinterpretations between adjacent patterns could be palliated by including intermediate patterns between those categories .


Estrogen-based hormone therapy ( HT ) attenuates abdominal fat gain after menopause , but whether HT improves abdominal fat loss during weight loss is unknown .


It was hypothesized that HT or a selective estrogen receptor modulator ( raloxifene ) would augment reductions in abdominal visceral fat during weight loss when compared to placebo , potentially increasing improvements in glucose tolerance and lipid profile .


Healthy postmenopausal women ( n = 119 ; age 50-70 yr ) underwent a 6-month weight-loss ( primarily exercise ) intervention with randomization to raloxifene ( 60 mg/d ) , HT ( conjugated estrogens , 0.625 mg/d ) , or placebo .


Outcomes were change in total and abdominal ( visceral and subcutaneous ) fat mass , lipid profile , and fasting and post-challenge glucose and insulin .


Neither HT nor raloxifene augmented loss of total or abdominal fat mass during exercise-induced weight loss when compared with placebo .


Weight loss-induced improvements in risk factors were similar among the three groups , except for a greater reduction in fasted glucose in the HT group ( difference in change [ 95 % CI ] from placebo ; -0.40 [ -0.76 , -0.05 ] ) and greater reductions in LDL ( -0.36 [ -0.63 , -0.09 ] ) and increases in HDL ( 0.15 [ 0.07 , 0.24 ] ) in both treatment groups .


Postmenopausal HT and raloxifene did not increase abdominal fat loss during weight loss , but did improve some cardiometabolic outcomes .


A subset analysis of the randomised , phase 3 , MDS-004 study to evaluate outcomes in patients with International Prognostic Scoring System ( IPSS ) - defined Low - / Intermediate ( Int ) -1 - risk myelodysplastic syndromes ( MDS ) with isolated del ( 5q ) .


Patients received lenalidomide 10mg/d ( days 1-21 ; n = 47 ) or 5mg/d ( days 1-28 ; n = 43 ) on 28-d cycles or placebo ( n = 45 ) .


From the placebo and lenalidomide 5mg groups , 84 % and 58 % of patients , respectively , crossed over to lenalidomide 5 or 10mg at 16wk , respectively .


Rates of red blood cell-transfusion independence ( RBC-TI ) 182d were higher in the lenalidomide 10mg ( 57.4 % ; P < 0.0001 ) and 5mg ( 37.2 % ; P = 0.0001 ) groups vs. placebo ( 2.2 % ) .


Cytogenetic response rates ( major + minor responses ) were 56.8 % ( P < 0.0001 ) , 23.1 % ( P = 0.0299 ) and 0 % , respectively .


Two-year cumulative risk of acute myeloid leukaemia progression was 12.6 % , 17.4 % and 16.7 % in the lenalidomide 10mg , 5mg , and placebo groups , respectively .


In a 6-month landmark analysis , overall survival was longer in lenalidomide-treated patients with RBC-TI 182d vs. non-responders ( P = 0.0072 ) .


The most common grade 3-4 adverse event was myelosuppression .


These data support the clinical benefits and acceptable safety profile of lenalidomide in transfusion-dependent patients with IPSS-defined Low - / Int-1-risk MDS with isolated del ( 5q ) .


Weight loss studies were conducted in children without asthma have demonstrated a reduction in systemic inflammation .


However , the impact of weight loss in the obese paediatric population with asthma has not been investigated .


To measure the effects of weight loss on markers of systemic inflammation in obese children with bronchial asthma .


Eighty obese children with bronchial asthma ( 42 boys , and 38 girls ) with mean age 13.86 3.21 years were divided into two equal groups .


The training group received diet regimen , exercise training in addition to the medical treatment for two months , where the control group received the medical treatment only .


There was a 17.5 % , 15.5 % , 22.4 % , 14.1 % and 15.9 % reduction in mean values of tumor necrosis factor-alpha ( TNF-alpha ) , interleukin-6 ( IL-6 ) , interleukin-8 ( IL-8 ) , Leptin and body mass index ( BMI ) respectively and 38.7 % increase in mean values of adiponectin in the training group .


While , there was a 0.7 % , 9.0 % , 2.8 % , 1.6 % and 1.2 % increase in mean values of TNF-alpha , IL-6 , IL-8 , Leptin and BMI respectively and 3.9 % decrease in mean values of adiponectin in the control group .


The mean values of TNF-alpha , IL-6 , IL-8 , Leptin and BMI was decreased and adiponectin was increased significantly in the training group , however the results of the control group were not significant .


Also , there were significant differences between both groups at the end of the study .


Weight loss improves markers of systemic inflammation in obese Saudi children with bronchial asthma .


To achieve an excellent bowel preparation , it is routine to require a clear liquid diet on the day before the procedure .


Unfortunately , this dietary modification may be poorly tolerated .


We examine whether a change in precolonoscopy dietary restriction can lead to better patient tolerance without compromising examination quality .


This is a prospective , blinded , randomized controlled trial of patients undergoing screening or surveillance colonoscopy .


The primary objective measures the effect of dietary modification on bowel prep quality .


Secondary endpoints include polyp detection , patient tolerance , withdrawal time , and patient acceptance .


A total of 200 patients were randomized to either ( a ) a low-residue diet for breakfast and lunch the day before the procedure or ( b ) clear liquids all day before the procedure .


All patients underwent an identical low-volume sodium sulfate split prep .


Bowel prep quality was scored using the Boston Bowel Preparation Scale ( BBPS ) .


A t test with TOST was used for noninferiority .


Secondary endpoints were compared using analysis .


Overall , 96.5 % of patients had a good or excellent bowel prep ( BBPS = 6 , 7 , 8 , or 9 ) .


LRD prep quality was noninferior to CLD prep quality ( LRD 7.8 vs. CLD 8.1 ) .


Polyp detection rates were similar ( 68 % vs. 65.4 % , P = 0.6899 ) .


Patient tolerance and acceptance did not differ .


Withdrawal times were equivalent between both groups ( 16.2 vs. 16.5 min , P = NS ) .


Patients allowed to have a limited low-residue diet before colonoscopy achieve a bowel prep quality that is noninferior to patients on a strict clear liquid diet limitation .


Furthermore , polyp detection rates , patient tolerance , and patient acceptance were similar between the 2 groups .


Prenatal supplementation with micronutrients may increase birth weight and thus improve infant health and survival in settings where infants and children are at risk of micronutrient deficiencies .


To assess whether vitamin A and/or zinc supplementation given during pregnancy can improve birth weight , birth length , neonatal morbidity , or infant mortality .


A double-blind , randomized controlled trial supplementing women ( n = 2173 ) in Central Java , Indonesia throughout pregnancy with vitamin A , zinc , combined vitamin A + zinc , or placebo .


Out of 2173 supplemented pregnant women , 1956 neonates could be evaluated .


Overall , zinc supplementation improved birth length compared to placebo or combined vitamin A + zinc ( 48.8 vs. 48.5 cm , p = 0.04 ) ; vitamin A supplementation improved birth length compared to placebo or combined vitamin A + zinc ( 48.7 vs. 48.2 cm , p = 0.04 ) .


These effects remained after adjusting for maternal height , pre-pregnancy weight , and parity .


There was no effect of supplementation on birth weight , the proportion of low birth weight , neonatal morbidity , or mortality .