Fifty-two ASA 1-2 patients scheduled for gynecological open abdominal surgery under combined general and epidural anesthesia were enrolled and randomized into two groups .


In ropivacaine group ( n = 26 ) the patients received 0.187 % ropivacaine and fentanyl 3.2 microg x ml ( -1 ) for postoperative epidural analgesia .


In levobupivacaine group ( n = 26 ) the patients received 0.187 % levobupivacaine and fentanyl 3.2 microg ml ( -1 ) .


Visual analogue scale ( resting pain and pain on mobilization ) , the amount of rescue analgesics and epidural anesthesia related adverse events such as hypotension , nausea and vomiting were observed for 48 hours after surgery .


There were no differences in visual analogue scale at all intervals between the two groups .


In levobupivacaine group the patients used less amounts of rescue analgesics than ropivacaine group ( P = 0.01 ) .


There were no differences in the incidences of postoperative hypotension , nausea and vomiting between the two groups .


Both 0.187 % ropivacaine and levobupivacaine similarly provide appropriate postoperative epidural analgesia for patients undergoing gynecological open abdominal surgery .


To determine the benefit of multifactorial treatment on microvascular complications among people with type 2 diabetes detected by screening .


This study was a multicenter cluster randomized controlled trial in primary care with randomization at the practice level .


In four centers in Denmark ; Cambridge , U.K. ; the Netherlands ; and Leicester , U.K. , 343 general practices participated in the trial .


Eligible for follow-up were 2,861 of the 3,057 people with diabetes detected by screening included in the original trial .


Biomedical data on nephropathy were collected in 2,710 ( 94.7 % ) participants , retinal photos in 2,190 ( 76.6 % ) , and questionnaire data on peripheral neuropathy in 2,312 ( 80.9 % ) .


The prespecified microvascular end points were analyzed by intention to treat .


Results from the four centers were pooled using fixed-effects meta-analysis .


Five years after diagnosis , any kind of albuminuria was present in 22.7 % of participants in the intensive treatment ( IT ) group and in 24.4 % in the routine care ( RC ) group ( odds ratio 0.87 [ 95 % CI 0.72-1 .07 ] ) .


Retinopathy was present in 10.2 % of the IT group and 12.1 % of the RC group ( 0.84 [ 0.64-1 .10 ] ) , and severe retinopathy was present in one patient in the IT group and seven in the RC group .


Neuropathy was present in 4.9 % and 5.9 % ( 0.95 [ 0.68-1 .34 ] ) , respectively .


Estimated glomerular filtration rate increased between baseline and follow-up in both groups ( 4.31 and 6.44 mL/min , respectively ) .


Compared with RC , an intervention to promote target-driven , intensive management of patients with type 2 diabetes detected by screening was not associated with significant reductions in the frequency of microvascular events at 5 years .


To determine the feasibility , acceptability and safety of using acupuncture to treat arm lymphoedema in women following treatment for breast cancer .


We conducted a randomised controlled trial of acupuncture compared with treatment as usual .


Twenty women with stable unilateral intransient lymphoedema present for at least 6months were recruited from Sydney , Australia .


The women received 12 acupuncture treatments administered to body and arm points on the non-lymphoedematous limb over 8weeks , twice weekly for 4weeks then once weekly for 4weeks .


Outcome measures included an assessment of interest to participate in the trial , identification of successful recruitment strategies , the appropriateness of eligibility criteria and compliance with treatment attendance .


Clinical outcomes were assessed at baseline and 8weeks and included extracellular fluid , lymphoedema symptoms , well-being and safety .


Acupuncture was an acceptable intervention in women with upper limb lymphoedema .


Compliance with the treatment protocol was high , with nine women completing all 12 treatments .


Outcome forms were completed by 17 women at 8weeks .


No major adverse occurrences , as defined by the study protocol , were reported from the acupuncture group although one woman found the needling uncomfortable , and no study participant experienced an increase in swelling of > 10 % .


There was no change in extracellular fluid or any patient-reported outcome measurement .


Lymphoedema is a persistent symptom experienced by women recovering from breast cancer .


Our study suggests that acupuncture may stabilise symptoms and no major safety concerns were identified , so further research is needed .


Australian New Zealand Clinical Trials Registry , http://www.anzctr.org.au ACTRN12612000607875 .


Inhaled corticosteroids , known to be effective as a maintenance medication in chronic asthma , have also been suggested as a therapy for acute asthma when given at high doses .


A double-blind , randomized , placebo-controlled trial was conducted in children aged 2 to 12 years with moderate or severe acute asthma , as determined based on a clinical score of 5 to 15 points , where 15 is the most severe .


We compared the addition of budesonide 1,500 g vs placebo to standard acute asthma treatment , which included salbutamol , ipratropium bromide , and a single dose of prednisolone 2 mg/kg given at the beginning of therapy .


The primary outcome was hospital admission rate within 4 h.


A total of 906 ED visits by children with moderate or severe acute asthma were evaluated .


Seventy-five cases out of 458 ( 16.4 % ) in the budesonide group vs 82 of 448 ( 18.3 % ) in the placebo group were admitted ( OR , 0.84 ; 95 % CI , 0.58-1 .23 ; P = .38 ) .


However , among cases with high baseline clinical score ( 13 ) , significantly fewer children were admitted in the budesonide group ( 27 of 76 [ 35.5 % ] ) than in the placebo group ( 39 of 73 [ 53.4 % ] ; OR , 0.42 ; 95 % CI , 0.19-0 .94 ; P = .03 ) .


The addition of budesonide nebulization did not decrease the admission rate of children with acute asthma overall .


However , it may decrease the admission rate of children with severe acute asthma .


ClinicalTrials.gov ; No. : NCT01524198 ; URL : www.clinicaltrials.gov


Although hepatitis A virus ( HAV ) and hepatitis B virus ( HBV ) infections are vaccine-preventable diseases , few homeless parolees coming out of prisons and jails have received the hepatitis A and B vaccination series .


The study focused on completion of the HAV and HBV vaccine series among homeless men on parole .


The efficacy of three levels of peer coaching ( PC ) and nurse-delivered interventions was compared at 12-month follow-up : ( a ) intensive peer coaching and nurse case management ( PC-NCM ) ; ( b ) intensive PC intervention condition , with minimal nurse involvement ; and ( c ) usual care ( UC ) intervention condition , which included minimal PC and nurse involvement .


Furthermore , we assessed predictors of vaccine completion among this targeted sample .


A randomized control trial was conducted with 600 recently paroled men to assess the impact of the three intervention conditions ( PC-NCM vs. PC vs. UC ) on reducing drug use and recidivism ; of these , 345 seronegative , vaccine-eligible subjects were included in this analysis of completion of the Twinrix HAV/HBV vaccine .


Logistic regression was added to assess predictors of completion of the HAV/HBV vaccine series and chi-square analysis to compare completion rates across the three levels of intervention .


Vaccine completion rate for the intervention conditions were 75.4 % ( PC-NCM ) , 71.8 % ( PC ) , and 71.9 % ( UC ; p = .78 ) .


Predictors of vaccine noncompletion included being Asian and Pacific Islander , experiencing high levels of hostility , positive social support , reporting a history of injection drug use , being released early from California prisons , and being admitted for psychiatric illness .


Predictors of vaccine series completion included reporting having six or more friends , recent cocaine use , and staying in drug treatment for at least 90 days .


Findings allow greater understanding of factors affecting vaccination completion in order to design more effective programs among the high-risk population of men recently released from prison and on parole .


Our study indicates a prototype blood-based variant Creutzfeldt-Jakob disease ( vCJD ) assay has sufficient sensitivity and specificity to justify a large study comparing vCJD prevalence in the United Kingdom with a bovine spongiform encephalopathy-unexposed population .


In a clinical diagnostic capacity , the assay 's likelihood ratios dramatically change an individual 's pretest disease odds to posttest probabilities and can confirm vCJD infection .


To determine the diagnostic accuracy of a prototype blood test for vCJD and hence its suitability for clinical use and for screening prion-exposed populations .


Retrospective , cross-sectional diagnostic study of blood samples from national blood collection and prion disease centers in the United States and United Kingdom .


Anonymized samples were representative of the US blood donor population ( n = 5000 ) , healthy UK donors ( n = 200 ) , patients with nonprion neurodegenerative diseases ( n = 352 ) , patients in whom a prion disease diagnosis was likely ( n = 105 ) , and patients with confirmed vCJD ( n = 10 ) .


Presence of vCJD infection determined by a prototype test ( now in clinical diagnostic use ) that captures , enriches , and detects disease-associated prion protein from whole blood using stainless steel powder .


The assay 's specificity among the presumed negative American donor samples was 100 % ( 95 % CI , 99.93 % -100 % ) and was confirmed in a healthy UK cohort ( 100 % specificity ; 95 % CI , 98.2 % -100 % ) .


Of potentially cross-reactive blood samples from patients with nonprion neurodegenerative diseases , no samples tested positive ( 100 % specificity ; 95 % CI , 98.9 % -100 % ) .


Among National Prion Clinic referrals in whom a prion disease diagnosis was likely , 2 patients with sporadic CJD tested positive ( 98.1 % specificity ; 95 % CI , 93.3 % -99.8 % ) .


Finally , we reconfirmed but could not refine our previous sensitivity estimate in a small blind panel of samples from unaffected individuals and patients with vCJD ( 70 % sensitivity ; 95 % CI , 34.8 % -93.3 % ) .


In conjunction with the assay 's established high sensitivity ( 71.4 % ; 95 % CI , 47.8 % -88.7 % ) , the extremely high specificity supports using the assay to screen for vCJD infection in prion-exposed populations .


Additionally , the lack of cross-reactivity and false positives in a range of nonprion neurodegenerative diseases supports the use of the assay in patient diagnosis .


Tadalafil once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia consistently shows statistically significant I-PSS improvements .


However , physicians and patients wish to know whether tadalafil provides rapid , clinically meaningful improvement in lower urinary tract symptoms .


In this post hoc analysis we integrated results from 4 placebo controlled studies to determine the duration of tadalafil once daily required to achieve clinically meaningful improvement .


We performed post hoc analysis of data integrated from 4 double-blind studies of tadalafil 5 mg and placebo once daily in 742 and 735 men , respectively , 45 years old or older with total I-PSS 13 or greater .


Two clinically meaningful improvement categories were assessed , including 1 ) 3-point or greater baseline to end point total I-PSS improvement and 2 ) 25 % or greater baseline to end point total I-PSS improvement .


I-PSS was assessed at weeks 4 , 8 and 12 in all studies , week 1 in 2 and week 2 in 1 .


Results in men treated with tadalafil who showed clinically meaningful improvement ( responders ) were further examined to determine the earliest time to clinically meaningful improvement .


Of 742 tadalafil treated patients 513 ( 69.1 % ) and 444 ( 59.8 % ) demonstrated category 1 and 2 clinically meaningful improvement , respectively , at the study end point .


Of 234 category 1 responders with week 1 assessments 140 ( 59.8 % ) achieved clinically meaningful improvement by week 1 and 407 of the total of 513 category 1 responders ( 79.3 % ) showed it by week 4 .


Of the 205 category 2 responders with week 1 assessments 103 ( 50.2 % ) achieved clinically meaningful improvement by week 1 while 322 of the 444 category 2 responders ( 72.5 % ) did so by week 4 .


Tadalafil 5 mg once daily led to clinically meaningful improvement in approximately two-thirds of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia .


More than half of this group of tadalafil treated responders achieved clinically meaningful improvement after 1 week of therapy and more than 70 % did so within 4 weeks .


Spatial neglect is a frequent and debilitating consequence of acquired brain injury and currently has no widely accepted standard of care .


While previous interventions for spatial neglect have targeted patients ' overt spatial deficits ( e.g. , reduced contralesional visual scanning ) , far fewer have directly targeted patients ' non-spatial deficits ( e.g. , sustained attention deficits ) .


Considering that non-spatial deficits have shown to be highly predictive of long-term disability , we developed a novel computer based training program that targets both sustained ( tonic ) and moment-to-moment ( phasic ) aspects of non-spatial attention ( Tonic and Phasic Alertness Training , TAPAT ) .


Preliminary studies demonstrate that TAPAT is safe and effective in improving both spatial and non-spatial attention deficits in the post-acute recovery phase in neglect patients .


The purpose of the current trial ( referred to as the REmediation of SPatial Neglect or RESPONSE trial ) is to compare TAPAT to an active control training condition , include a larger sample of patients , and assess both cognitive and functional outcomes .


We will employ a multi-site , longitudinal , blinded randomized controlled trial ( RCT ) design with a target sample of 114 patients with spatial neglect .


Patients will either perform , at their home , the experimental TAPAT training program or an active control computer games condition for thirty minutes/day , five days a week , over three months .


Patients will be assessed on a battery of cognitive and functional outcomes on three occasions : a ) immediately before training , b ) within forty-eight hours post completion of total training , and c ) after a three-month no-contact period post completion of total training , to assess the longevity of potential training effects .


The strengths of this protocol are that it tests an innovative , in-home administered treatment that targets a fundamental deficit in neglect , employs highly sensitive computer-based assessments of cognition as well as functional outcomes , and incorporates a large sample size ( relative to other neglect treatment studies ) in an RCT design .


ClinicalTrials.gov identifier , NCT01965951 .


To observe the clinical efficacy of acupuncture combined with auricular point sticking for menstrual headache and to discuss its mechanism .


Eighty-five patients with menstrual headache were randomly divided into an observation group ( 43 cases ) and a control group ( 42 cases ) .


The observation group was treated with body acupuncture combined with auricular point sticking and the control group was treated with flunarizine hydrochloride capsules orally .


The treatments of 3 menstrual cycles were required .


The clinical efficacy was observed in the two groups .


The content of serum prostaglandin F2 , ( PGF2 ) and plasma arginine vasopressin ( AVP ) in the menstrual periods of some patients randomly selected in the two groups was tested before and after treatment and was compared with that of 20 cases in a normal group .


Results The total effective rate was 95.4 % ( 41/43 ) in the observation group which was obviously superior to 81.0 % ( 34/42 ) in the control group ( P < 0.01 ) .


Before treatment , the content of serum PGF2 and plasma AVP of patients in the two groups was higher than that in the normal group ( all P < 0.01 ) .


After treatment , the content of serum PGF2 and plasma AVP was lower than that before treatment in the two groups ( P < 0.01 , P < 0.05 ) .


The content of serum PGF2 in the observation group was decreased significantly compared with that in the control group ( P < 0.05 ) and returned to the level of the normal group .


Body acupuncture combined with auricular point sticking achieves positive efficacy for menstrual headache and its mechanism could be related to regulating the abnormal levels of serum PGF2 and plasma AVP .


It was the aim of this study to compare the efficacy of ozone therapy and drug treatment in patients with painful temporomandibular joint ( TMJ ) disorder ( TMD ) .


A total of 63 patients with TMD were enrolled ; 33 were treated with bio-oxidative therapy and 30 with a ketoprofen tablet thiocolchicoside capsule 2 1 for 7 days .


Maximum voluntary interincisal mouth opening ( MMO ) was measured in millimeters using a scale and recorded during the pre - and posttreatment periods .


The patients evaluated their subjective pain using a visual analogue scale ( VAS ) .


Data were analyzed using the Mann-Whitney U test , the Kolmogorov-Smirnov test , and the independent t test .


The mean MMO of the group that received ozone therapy during the pretreatment period was 46.51 8.2 mm , and it immediately increased to 48.78 7.5 mm after 1 week of ozone therapy , which was statistically significant ( p = 0.04 ) .


For those who received medication , the mean MMO during the pretreatment period was 46.30 mm , and at the end of 1 week it was 46.9 mm .


In the ozone group , 29 % of patients showed a gradual decrease in their VAS pain scores compared to pretreatment values ( 6.3 2.1 to 3.0 2.2 ) .


In the medication group , 24 % of patients showed a significant decrease in VAS pain scores during the follow-up period ( 6.9 1.4 to 5.0 1.5 ) .


This study showed that bio-oxidative therapy was a more effective treatment than medication therapy for relieving TMJ pain .


Previous studies have demonstrated pronounced reduction of REM sleep on the first nights following major surgery which may influence pain , analgesic use , and recovery .


This placebo-controlled , randomized , double-blind study set out to evaluate the effect of zolpidem on sleep architecture in an elderly population undergoing fast-track total hip and knee arthroplasty ( THA/TKA ) with length of stay < 3 days .


Twenty patients ( 60 years ) undergoing THA or TKA in a standardized setup with spinal anesthesia and multimodal opioid-sparing postoperative analgesia were included .


Polysomnography measures were performed for 2 nights , 1 night at home prior to surgery and on the first night after surgery , when the patient received placebo or zolpidem 10 mg .


Analgesic use , pain levels , and subjective measures of fatigue and sleep quality were recorded .


Analysis of sleep data was performed according to the American Academy of Sleep Medicine manual .


Objective sleep data did not show a significant difference between groups in any of the sleep stages .


However , subjective data on sleep quality and fatigue showed significantly less fatigue and better sleep quality in the zolpidem group ( p < 0.05 ) , and reduced objectively recorded number of arousals ( p = 0.004 ) .


Levels of pain and opioid use were similar in the 2 groups .


Our objective data did not support the primary hypothesis that one night 's treatment with zolpidem would significantly improve sleep architecture following major surgery , although there was improved feeling of sleep quality and fatigue associated with fewer postoperative arousals .


Krenk L ; Jennum P ; Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement .


This study aimed to assess the effects of sampling interval ( SI ) of computed tomographic ( CT ) perfusion acquisitions on CT perfusion values in normal liver and liver metastases from neuroendocrine tumors .


Computed tomographic perfusion in 16 patients with neuroendocrine liver metastases was analyzed using distributed-parameter modeling to yield tissue blood flow , blood volume , mean transit time , permeability , and hepatic arterial fraction for tumor and normal liver .


Computed tomographic perfusion values for the reference SI of 0.5 s ( SI0 .5 ) were compared with those of SI data sets of 1 second , 2 seconds , 3 seconds , and 4 seconds using mixed-effects model analyses .


Increases in SI beyond 1 second were associated with significant and increasing departures of CT perfusion parameters from the reference values at SI0 .5 ( P 0.0009 ) .


Computed tomographic perfusion values deviated from the reference with increasing uncertainty with increasing SIs .


Findings for normal liver were concordant .


Increasing SIs beyond 1 second yield significantly different CT perfusion parameter values compared with the reference values at SI0 .5 .


Guanfacine extended - release ( GXR ) is approved for the treatment of attention-deficit/hyperactivity disorder in children and adolescents .


As part of the clinical development of GXR , and to further explore the effect of guanfacine on QT intervals , a thorough QT study of guanfacine was conducted ( ClinicalTrials .


gov identifier : NCT00672984 ) .


In this double-blind , 3-period , crossover trial , healthy adults ( n = 83 ) received immediaterelease guanfacine ( at therapeutic ( 4 mg ) and supra-therapeutic ( 8 mg ) doses ) , placebo , and 400 mg moxifloxacin ( positive control ) in 1 of 6 randomly assigned sequences .


Continuous 12-lead electrocardiograms were extracted , and guanfacine plasma concentrations were assessed pre-dose and at intervals up to 24 hours post-dose .


QT intervals were corrected using 2 methods : subject-specific ( QTcNi ) and Fridericia ( QTcF ) .


Time-matched analyses examined the largest , baseline-adjusted , drug-placebo difference in QTc intervals .


In the QTcNi analysis , the largest 1-sided 95 % upper confidence bound ( UCB ) through hour 12 was 1.94 ms ( 12 hours postdose ) .


For the 12-hour QTcF analysis , the largest 1-sided 95 % UCB was 10.34 ms ( 12 hours post-supratherapeutic dose ) , representing the only 1-sided 95 % UCB > 10 ms. Following the supra-therapeutic dose , maximum guanfacine plasma concentration was attained at 5.0 hours ( median ) post-dose .


Assay sensitivity was confirmed by moxifloxacin results .


Among guanfacine-treated subjects , most treatment-emergent adverse events were mild ( 78.9 % ) ; dry mouth ( 65.8 % ) and dizziness ( 61.8 % ) were most common .


Neither therapeutic nor supra-therapeutic doses of guanfacine prolonged QT interval after adjusting for heart rate using individualized correction , QTcNi , through 12 hours postdose .


Guanfacine does not appear to interfere with cardiac repolarization of the form associated with pro-arrhythmic drugs .


Previous studies reported increased white blood cell counts ( WBCCs ) , an inflammatory marker , in hypertension , prehypertension and metabolic syndrome .


Evidence suggests that inflammation precedes blood pressure ( BP ) elevation and may contribute to incident hypertension .


Angiotensin receptor blockers ( ARBs ) may reduce inflammation .


We analyzed WBCC trends in TRial Of Preventing HYpertension ( TROPHY ) to determine if this inflammatory marker predicted incident hypertension in prehypertensive individuals and whether randomized assignment to the ARB candesartan ( 391 individuals ) for 2 years , lowered WBCC compared with placebo-treated controls ( 381 individuals ) .


A new analysis of TROPHY trial data .


In the total population , baseline BMI correlated with WBCC ( r = 0.185 , P < 0.0001 ) , neutrophils ( r = 0.135 , P < 0.001 ) and lymphocytes ( r = 0.204 , P < 0.0001 ) .


Baseline triglycerides also correlated significantly with inflammatory markers .


Despite a wide range of home BP ( HBP ) values , HBP did not correlate with baseline WBCC counts .


After 2 years , candesartan decreased placebo corrected HBP by -5.5 / -2.5 mmHg , ( P < 0.0001 ) , but WBCC , neutrophil and lymphocyte counts were not different in placebo and in candesartan groups .


Baseline WBCC , neutrophils and lymphocyte counts did not predict incident hypertension in the placebo group .


In TROPHY , candesartan lowered BP but did not alter WBCC .


Baseline WBCC did not predict incident hypertension .


Our findings do not support the hypothesis that inflammation contributes to incident hypertension or that ARB treatment suppresses inflammation .


The significant independent association of WBCC with baseline BMI and triglycerides is consistent with the evidence that obesity and insulin resistance are associated with inflammation .


The findings highlight the importance of effective lifestyle modification in prehypertension to reduce inflammatory cardio-metabolic risk and suppress transition to hypertension .


Sociodemographic differences have been observed in the treatment of extremely premature ( periviable ) neonates , but the source of this variation is not well understood .


We assessed the feasibility of using simulation to test the effect of maternal race and insurance status on shared decision making ( SDM ) in periviable counseling .


We conducted a 2 2 factorial simulation experiment in which obstetricians and neonatologists counseled 2 consecutive standardized patients diagnosed with ruptured membranes at 23 weeks , counterbalancing race ( black/white ) and insurance status using random permutation .


We assessed verisimilitude of the simulation in semistructured debriefing interviews .


We coded physician communication related to resuscitation , mode of delivery , and steroid decisions using a 9-point SDM coding framework and then compared communication scores by standardized patient race and insurer using analysis of variance .


Sixteen obstetricians and 15 neonatologists participated ; 71 % were women , 84 % were married , and 75 % were parents ; 91 % of the physicians rated the simulation as highly realistic .


Overall , SDM scores were relatively high , with means ranging from 6.4 to 7.9 ( of 9 ) .


There was a statistically significant interaction between race and insurer for SDM related to steroid use and mode of delivery ( P < 0.01 and P = 0.01 , respectively ) .


Between-group comparison revealed nonsignificant differences ( P = < 0.10 ) between the SDM scores for privately insured black patients versus privately insured white patients , Medicaid-insured white patients versus Medicaid-insured black patients , and privately insured black patients versus Medicaid-insured black patients .


This study confirms that simulation is a feasible method for studying sociodemographic effects on periviable counseling .


Shared decision making may occur differentially based on patients ' sociodemographic characteristics and deserves further study .


Increased left ventricular ( LV ) size is associated with cardiovascular mortality and morbidity .


Once non-contrast cardiac computed tomography ( CT ) is performed for other purposes , information of LV size is readily available .


To determine the association of gated CT-derived LV size with cardiovascular risk factors and coronary artery calcification ( CAC ) and to describe age - and gender-specific normative values in a general population cohort .


LV area was quantified from non-contrast-enhanced CT in axial , end-diastolic images at a mid-ventricular slice in participants of the population-based Heinz Nixdorf Recall Study , free of known cardiovascular disease .


LV index ( LVI ) was calculated by the quotient of LV area and body surface area ( BSA ) .


Crude and adjusted regression analyses were used to determine the association of LVI with risk factors and CAC .


Overall , 3926 subjects ( age 59 8 years , 53 % women ) were included in this analysis .


From quantification in end-diastolic phase , men had larger LV index ( 2232 296 mm ( 2 ) / m ( 2 ) vs. 2088 251 mm ( 2 ) / m ( 2 ) , both P < 0.0001 ) .


LVI was strongly correlated systolic blood pressure ( men , PE [ 95 % CI ] : 22.8 [ 15.5-30 .2 ] mm ( 2 ) / 10 mmHg ; women , 23.4 [ 18.1-28 .6 ] ) , and antihypertensive medication ( men , 45.2 [ 14.7-75 .8 ] mm ( 2 ) ; women : 46.5 [ 22.7-70 .2 ] , all P < 0.005 ) .


Cholesterol levels were associated with LVI in univariate analysis , however , correlations were low ( R ( 2 ) 0.04 ) .


In multivariable regression , blood pressure , antihypertensive medication and cholesterol levels , remained associated with LVI ( P < 0.05 ) .


LVI was linked with CAC in unadjusted ( men , increase of CAC + 1 by 13.0 % [ 1.4-25 .8 ] with increased LVI by 1 standard deviation of LVI , P = 0.03 ; women , 20.7 % [ 10.0-32 .3 ] , P < 0.0001 ) and risk factor adjusted models ( men , 14.6 % [ 3.7-26 .6 ] , P = 0.007 ) ; women , 17.4 % [ 7.8-27 .8 ] , P = 0.0002 ) .


Non-contrast cardiac CT derived LV index is associated with body size and hypertension .


LVI is weakly linked with CAC-score .


Further studies need to evaluate whether assessment of LV dimensions from cardiac CT helps identifying subjects with increased cardiovascular risk .


To compare the outcomes of surgical periodontal therapy with and without initial scaling and root planing .


Twenty-four patients with severe chronic periodontitis were enrolled in this pilot , randomized controlled clinical trial .


Patients were equally allocated into two treatment groups : Control group was treated with scaling and root planing , re-evaluation , followed by Modified Widman Flap surgery and test group received similar surgery without scaling and root planing .


Clinical attachment level , probing depth and bleeding on probing were recorded .


Standardized radiographs were analysed for linear bone change from baseline to 6 months .


Wound fluid inflammatory biomarkers were also assessed .


Both groups exhibited statistically significant improvement in clinical attachment level and probing depth at 3 and 6 months compared to baseline .


A statistically significant difference in probing depth reduction was found between the two groups at 3 and 6 months in favour of the control group .


No statistically significant differences in biomarkers were detected between the groups .


Combined scaling and root planing and surgery yielded greater probing depth reduction as compared to periodontal surgery without initial scaling and root planing .


Enthusiasm for simulation early in cardiothoracic surgery training is growing , yet evidence demonstrating its utility is limited .


We examined the effect of supervised and unsupervised training on coronary anastomosis performance in a randomized trial among medical students .


Forty-five medical students were recruited for this single-blinded , randomized controlled trial using a low-fidelity simulator .


After viewing an instructional video , all participants attempted an anastomosis .


Subsequently , the participants were randomized to 1 of 3 groups : control ( n = 15 ) , unsupervised training ( n = 15 ) , or supervised training with a cardiothoracic surgeon or fellow ( n = 15 ) .


Both the supervised and unsupervised groups practiced for 1 hour per week .


After 4 weeks , the participants repeated the anastomosis .


All pre - and posttraining performances were videotaped and rated independently by 3 cardiothoracic surgeons blinded to the randomization .


All raters scored 13 assessment items on a 1 to 5 ( low-high ) scale along with an overall pass/fail rating .


After the training period , all 3 groups showed significant improvements in composite scores ( control : +0.52 0.69 [ P = .014 ] , unsupervised : +1.05 0.48 [ P < .001 ] , and supervised : +1.10 0.84 [ P < .001 ] ) .


Compared with control group , both supervised ( P = .005 ) and unsupervised trainees ( P = .005 ) demonstrated a significant improvement .


Between the supervised and unsupervised groups there were no statistically significant differences in composite scores .


Practice on low-fidelity simulators enabled trainees to improve on a broad range of skills ; however , the additional effect of attending-level supervision is limited .


In an era of increasing staff surgeon responsibilities , unsupervised practice may be sufficient for inexperienced trainees .


Cerebral vasospasm following subarachnoid hemorrhage ( SAH ) causes significant morbidity in a delayed fashion .


The authors recently published a new scale that grades the maximum thickness of SAH on axial CT and is predictive of vasospasm incidence .


In this study , the authors further investigate whether different aneurysm locations result in different SAH clot burdens and whether any concurrent differences in ruptured aneurysm location and maximum SAH clot burden affect vasospasm incidence .


Two hundred fifty patients who were part of a prospective randomized controlled trial were reviewed .


Most outcome and demographic variables were included as part of the prospective randomized controlled trial .


Additional variables were also collected at a later time , including vasospasm data and maximum clot thickness .


Aneurysms were categorized into 1 of 6 groups : intradural internal carotid artery aneurysms , vertebral artery ( VA ) aneurysms ( including the posterior inferior cerebellar artery ) , basilar trunk or basilar apex aneurysms , middle cerebral artery aneurysms , pericallosal aneurysms , and anterior communicating artery aneurysms .


Twenty-nine patients with nonaneurysmal SAH were excluded .


Patients with pericallosal aneurysms had the least average maximum clot burden ( 5.3 mm ) , compared with 6.4 mm for the group overall , but had the highest rate of symptomatic vasospasm ( 56 % vs 22 % overall , OR 4.9 , RR 2.7 , p = 0.026 ) .


Symptomatic vasospasm occurrence was tallied in patients with clinical deterioration attributable to delayed cerebral ischemia .


There were no significant differences in maximum clot thickness between aneurysm sites .


Middle cerebral artery aneurysms resulted in the thickest mean maximum clot ( 7.1 mm ) but rates of symptomatic and radiographic vasospasm in this group were statistically no different compared with the overall group .


Vertebral artery aneurysms had the worst 1-year modified Rankin scale ( mRS ) scores ( 3.0 vs 1.9 overall , respectively ; p = 0.0249 ) .


A 1-year mRS score of 0-2 ( good outcome ) was found in 72 % of patients overall , but in only 50 % of those with pericallosal and VA aneurysms , and in 56 % of those with basilar artery aneurysms ( p = 0.0044 ) .


Patients with stroke from vasospasm had higher mean clot thickness ( 9.71 vs 6.15 mm , p = 0.004 ) .


The location of a ruptured aneurysm minimally affects the maximum thickness of the SAH clot but is predictive of symptomatic vasospasm or clinical deterioration from delayed cerebral ischemia in pericallosal aneurysms .


The worst 1-year mRS outcomes in this cohort of patients were noted in those with posterior circulation aneurysms or pericallosal artery aneurysms .


Patients experiencing stroke had higher mean clot burden .


To evaluate the short-term benefits of simple relaxation techniques in white-collar employees .


The study was a two-arm parallel group randomized controlled trial .


152 employees were randomly assigned to receive the 8-week programme ( N = 80 ) ( relaxation breathing and progressive muscle relaxation , twice a day ) or not ( wait-list group N = 72 ) .


Self-reported validated measures were used to evaluate perceived stress , health locus of control , job and lifestyle related variables .


Saliva cortisol were also sampled and measured .


Adjusted mean changes on outcomes were estimated by linear mixed model analysis .


127 employees were finally analyzed ( 68 in the intervention and 59 in the control group ) .


Specific stress-related symptoms , psychological job demands and cortisol levels were found to be significantly decreased after 8-weeks in the intervention group .


The result was probably affected by the general socio-economic condition during the study period .


Cortisol levels were also significantly related with age , family situation , gender and sampling time .


Simple relaxation training ( diaphragmatic breathing and progressive muscle relaxation ) could benefit employees and it is strongly proposed that these and other similar techniques should be tested in various labour settings .


Faecal short chain fatty acids ( SCFAs ) are produced by the gut microflora .


We have previously reported high faecal SCFA levels in children with coeliac disease ( CD ) , indicating alteration in gut microfloral metabolism .


Data accumulated over recent decades by us and others suggest that wheat-free oats can safely be included in a gluten-free diet ( GFD ) .


However , concerns have been raised with respect to the safety of oats in a subset of coeliacs .


To describe faecal SCFA patterns in children with newly diagnosed CD treated for 1 year with a GFD with or without oats .


This report is part of a randomised , double-blind study on the effect of a GFD containing oats ( GFD-oats ) vs. a standard GFD ( GFD-std ) .


Faecal samples were received from 34 children in the GFD-oats group and 37 in the GFD-std group at initial diagnosis and/or after 1 year on a GFD .


Faecal SCFAs were analysed .


The GFD-std group had a significantly lower total faecal SCFA concentration at 12 months compared with 0 months ( P < 0.05 ) .


In contrast , total SCFA in the GFD-oats group remained high after 1 year on the GFD .


The children in the GFD-oats group had significantly higher acetic acid ( P < 0.05 ) , n-butyric acid ( P < 0.05 ) and total SCFA concentration ( P < 0.01 ) after 1-year diet treatment compared to the GFD-std group .


Our results indicate that oats do affect the gut microflora function , and that some coeliac children receiving oats may develop gut mucosal inflammation , that may present a risk for future complications .


Prucalopride is a selective , high-affinity agonist of the 5-hydroxytryptamine ( serotonin ) receptor 4 that enhances motility in the gastrointestinal tract .


We performed a multicenter , randomized , placebo-controlled , double-blind , phase 3 trial to evaluate the efficacy and safety of prucalopride in children ( 6 months to 18 years old ) with functional constipation .


Children with functional constipation , based on the Rome III criteria , were given prucalopride ( children 50 kg were given a 0.04 mg/kg oral solution ; children > 50 kg were given a 2-mg tablet ) or placebo once daily for 8 weeks .


The primary efficacy end point was the proportion of children with toileting skills who had a mean of 3 spontaneous bowel movements/week and 1 episode of fecal incontinence/2 weeks , from study weeks 5-8 ( responders ) .


Adverse events , clinical laboratory values , and electrocardiograms were monitored .


Efficacy and safety were assessed in 213 children ( 106 prucalopride , 107 placebo ) .


Twenty-five percent were younger than 4 years old , 50 % were 4-11 years old , and 25 % were 12-18 years old ; 55.4 % were girls .


At screening , 62.3 % of patients in the prucalopride group and 55.1 % in the placebo group had a history of fecal incontinence ; 60.4 % and 55.1 % in the prucalopride and placebo groups , respectively , had a mean of 1 spontaneous bowel movements/week .


The proportion of responders was similar between groups ( prucalopride , 17.0 % and placebo , 17.8 % ) .


There were no statistically significant differences in the primary efficacy end point when patients were stratified by sex , age group , or country .


The incidence of treatment-emergent adverse events was similar in the prucalopride ( 69.8 % ) and placebo ( 60.7 % ) groups .


Prucalopride , although generally well tolerated , was not more effective than placebo in children with functional constipation .


ClinicalTrials.gov Number : NCT01330381 .


Epidemiologic studies have reported inconsistent associations of vitamin D and prostate cancer risk ; however , few have adequately controlled for detection bias related to prostate-specific antigen ( PSA ) screening , and the results of many studies may be affected by occult prostate cancers among controls .


Data for this nested case-control analysis ( n = 1,695 cases/1 ,682 controls ) are from the Prostate Cancer Prevention Trial .


Baseline serum was analyzed for 25-hydroxyvitamin D [ 25 ( OH ) D ] .


The presence or absence of cancer was subsequently determined by prostate biopsy .


Polytomous logistic regression models were used to estimate associations of 25 ( OH ) D with risk of total , Gleason 2-6 , Gleason 7 , and Gleason 8-10 prostate cancer .


Results are presented for placebo and finasteride arms separately and combined .


There were no associations of serum 25 ( OH ) D with total prostate cancer risk .


For Gleason 2-6 cancers , results were inconsistent across treatment arms with a suggestion of increased risk in the placebo arm only ; however , there was no dose-response relationship .


For Gleason 8-10 prostate cancers , 25 ( OH ) D concentrations were associated with a linear decrease in risk among combined treatment arms [ quartile 4 vs. 1 : OR , 0.55 ; 95 % confidence interval ( CI ) , 0.32-0 .94 ; P ( trend ) = 0.04 ] .


These findings were somewhat stronger among men 65 versus 55-64 years at baseline ( quartile 4 vs. 1 : OR , 0.40 ; 95 % CI , 0.18-0 .88 vs. OR , 0.73 ; 95 % CI , 0.35-1 .52 , respectively ; P ( interaction ) = 0.52 ) .


Higher serum 25 ( OH ) D may modestly increase risk of Gleason 2-6 disease and more substantially reduce risk of Gleason 8-10 prostate cancer .


Vitamin D may have different effects for different stages of prostate cancers .


Antidepressant response varies between patients , possibly due to differences in the rate cytochrome P450 enzymes metabolise antidepressants into inactive compounds .


Drug metabolism rates are influenced by common variants in the genes encoding these enzymes .


However , it remains unclear whether treatment outcomes can be predicted by either CYP450 genotype or antidepressant serum concentration .


In GENDEP ( a pharmacogenetic study of depressed individuals treated with either escitalopram or nortriptyline ) , serum concentrations of antidepressants and their primary metabolite were measured after eight weeks treatment and variants in CYP2D6 and CYP2C19 were genotyped .


Amongst patients taking escitalopram ( n = 223 ) , the genotype CYP2C19 was significantly associated with escitalopram serum concentrations and desmethylescitalopram : escitalopram ratio .


For those taking nortriptyline ( n = 161 ) , the CYP2D6 genotype was significantly associated with nortriptyline and 10-hydroxynortriptyline serum concentrations and 10-hydroxynortriptyline : nortrip-tyline ratio .


CYP450 genotypes conferring greater enzyme activity were linked to lower drug serum concentrations and higher metabolite : drug ratios .


Nonetheless , no significant association was found between either CYP450 genotype or antidepressant serum concentration and treatment response .


While there is a significant relationship between the CYP450 genotype and serum concentrations of escitalopram and nortriptyline , the genotypes are not predictive of differences in treatment response for either drug .


Furthermore , differences in antidepressant serum concentrations are not associated with variability in treatment response .


Atrial fibrillation is a leading preventable cause of recurrent stroke for which early detection and treatment are critical .


However , paroxysmal atrial fibrillation is often asymptomatic and likely to go undetected and untreated in the routine care of patients with ischemic stroke or transient ischemic attack ( TIA ) .


We randomly assigned 572 patients 55 years of age or older , without known atrial fibrillation , who had had a cryptogenic ischemic stroke or TIA within the previous 6 months ( cause undetermined after standard tests , including 24-hour electrocardiography [ ECG ] ) , to undergo additional noninvasive ambulatory ECG monitoring with either a 30-day event-triggered recorder ( intervention group ) or a conventional 24-hour monitor ( control group ) .


The primary outcome was newly detected atrial fibrillation lasting 30 seconds or longer within 90 days after randomization .


Secondary outcomes included episodes of atrial fibrillation lasting 2.5 minutes or longer and anticoagulation status at 90 days .


Atrial fibrillation lasting 30 seconds or longer was detected in 45 of 280 patients ( 16.1 % ) in the intervention group , as compared with 9 of 277 ( 3.2 % ) in the control group ( absolute difference , 12.9 percentage points ; 95 % confidence interval [ CI ] , 8.0 to 17.6 ; P < 0.001 ; number needed to screen , 8 ) .


Atrial fibrillation lasting 2.5 minutes or longer was present in 28 of 284 patients ( 9.9 % ) in the intervention group , as compared with 7 of 277 ( 2.5 % ) in the control group ( absolute difference , 7.4 percentage points ; 95 % CI , 3.4 to 11.3 ; P < 0.001 ) .


By 90 days , oral anticoagulant therapy had been prescribed for more patients in the intervention group than in the control group ( 52 of 280 patients [ 18.6 % ] vs. 31 of 279 [ 11.1 % ] ; absolute difference , 7.5 percentage points ; 95 % CI , 1.6 to 13.3 ; P = 0.01 ) .


Among patients with a recent cryptogenic stroke or TIA who were 55 years of age or older , paroxysmal atrial fibrillation was common .


Noninvasive ambulatory ECG monitoring for a target of 30 days significantly improved the detection of atrial fibrillation by a factor of more than five and nearly doubled the rate of anticoagulant treatment , as compared with the standard practice of short-duration ECG monitoring .


( Funded by the Canadian Stroke Network and others ; EMBRACE ClinicalTrials.gov number , NCT00846924 . )


Acute lymphoblastic leukemia ( ALL ) is the most common pediatric cancer .


Monitoring minimal residual disease ( MRD ) by using real-time quantitative polymerase chain reaction ( RQ-PCR ) provides information for patient stratification and individual risk-directed treatment .


Cooperative studies have documented that measurement of blast clearance from the bone marrow during and after induction therapy identifies patient populations with different risk of relapse .


We explored the possible contribution of measurements of MRD during the course of treatment .


We used RQ-PCR to detect MRD in 110 unselected patients treated in Italy in the International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia ( AIEOP-BFM ALL 2000 ) .


The trial took place in AIEOP centers during postinduction chemotherapy .


Results were categorized as negative , low positive ( below the quantitative range [ < 5 10 ( -4 ) ] ) , or high positive ( 5 10 ( -4 ) ) .


Patients with at least one low-positive or high-positive result were assigned to the corresponding subgroup .


Patients who tested high positive , low positive , or negative had significantly different cumulative incidences of leukemia relapse : 83.3 % , 34.8 % , and 8.6 % , respectively ( P < .001 ) .


Two thirds of positive cases were identified within 4 months after induction-consolidation therapy , suggesting that this time frame may be most suitable for cost-effective MRD monitoring , particularly in patients who did not clear their disease at the end of consolidation .


These findings provide further insights into the dynamic of MRD and the ongoing effort to define molecular relapse in childhood ALL .


Our objective was to assess therapeutic non-inferiority of dual treatment with lopinavir-ritonavir and lamivudine to triple treatment with lopinavir-ritonavir plus two nucleos ( t ) ides for maintenance of HIV-1 viral suppression .


In this randomised , open-label , non-inferiority trial , we recruited patients from 32 HIV units in hospitals in Spain and France .


Eligible patients were HIV-infected adults ( aged 18 years ) with HIV-1 RNA of less than 50 copies per mL , for at least 6 months on triple treatment with lopinavir-ritonavir ( twice daily ) plus lamivudine or emtricitabine and a second nucleos ( t ) ide , with no resistance or virological failure to these drugs , and no positive hepatitis B serum surface antigen .


Investigators at each centre randomly assigned patients ( 1:1 ; block size of four ; stratified by time to suppression [ < 1 year or > 1 year ] and nadir CD4 cell count [ < 100 cells per L or > 100 cells per L ] ; computer-generated random sequence ) to continue triple treatment or switch to dual treatment ( oral lopinavir 400 mg and oral ritonavir 100 mg twice daily plus oral lamivudine 300 mg once daily ) .


The primary endpoint was response to treatment in the intention-to-treat population ( all randomised patients ) at 48 weeks .


The non-inferiority margin was 12 % .


This study is registered with ClinicalTrials.gov , number NCT01471821 .


Between Oct 1 , 2011 , and April 1 , 2013 , we randomly assigned 250 participants to continue triple treatment ( 127 [ 51 % ] patients ) or switch to dual treatment ( 123 [ 49 % ] patients ) .


In the intention-to-treat population , 110 ( 866 % ) of 127 patients in the triple-treatment group responded to treatment versus 108 ( 878 % ) of 123 in the dual-treatment group ( difference -12 % [ 95 % CI -96 to 73 ] ; p = 092 ) , meeting the criteria for non-inferiority .


Serious adverse events occurred in eight ( 7 % ) patients in the triple-treatment group and five ( 4 % ) in the dual-treatment group ( p = 0515 ) , and study drug discontinuations due to adverse events occurred in four ( 3 % ) in the triple-treatment group and one ( 1 % ) in the dual-treatment group ( p = 0223 ) .


Dual treatment with lopinavir-ritonavir plus lamivudine has non-inferior therapeutic efficacy and is similarly tolerated to triple treatment .


AbbVie and Red Temtica Cooperativa de Investigacin en Sida .


Factors and outcomes associated with end-of-life decision-making among patients during clinical trials in the intensive care unit are unclear .


We sought to determine patterns and outcomes of Do Not Resuscitate ( DNR ) decisions among critically ill patients with acute respiratory distress syndrome ( ARDS ) enrolled in a clinical trial .


We performed a secondary analysis of data from the ARDS Network Fluid and Catheter Treatment Trial ( FACTT ) , collected between 2000 and 2005 .


We calculated mortality outcomes stratified by code status , and compared baseline characteristics of patients who became DNR during the trial with participants who remained full code .


Among 809 FACTT participants with a code status recorded , 232 ( 28.7 % ) elected DNR status .


Specifically , 37 ( 15.9 % ) chose to withhold cardiopulmonary resuscitation alone , 44 ( 19.0 % ) elected to withhold some life support measures in addition to cardiopulmonary resuscitation , and 151 ( 65.1 % ) had life support withdrawn .


Admission severity of illness as measured by APACHE III score was strongly associated with election of DNR status ( odds ratio , 2.2 ; 95 % confidence interval , 1.85-2 .62 ; P < 0.0001 ) .


Almost all ( 97.0 % ; 225 of 232 ) patients who selected DNR status died , and 79 % ( 225 of 284 ) of patients who died during the trial were DNR .


Among patients who chose DNR status but did not elect withdrawal of life support , 91 % ( 74 of 81 ) died .


The vast majority of deaths among clinical trial patients with ARDS were preceded by a DNR order .


Unlike other studies of end-of-life decision-making in the intensive care unit , nearly all patients who became DNR died .


The impact of variation of practice in end-of-life decision-making during clinical trials warrants further study .


Etravirine ( ETR ) was approved for patients with virological failure and antiretroviral resistance mutations .


It has also shown antiviral efficacy in antiretroviral-nave patients .


However , data on the switching from protease inhibitors ( PI ) to ETR are lacking .


HIV-1-infected patients with suppressed viral load ( VL ) during a PI-containing regimen ( > 12 months ) and no previous virological failure were randomized to switch from the PI to ETR ( 400 mg/day , dissolved in water ) ( ETR group , n = 22 ) or to continue with the same regimen ( control group , n = 21 ) .


Percentage of patients with VL 50 copies/mL were assessed at week 48 , as well as changes in CD4 T-cell counts and metabolic profile .


We included 43 patients [ 72.9 % male , 46.3 ( 42.2 ; 50.6 ) years ] .


Two patients receiving ETR ( grade-1 diarrhea and voluntary discontinuation ) and another in the control group ( simplification ) discontinued therapy early .


No patients presented virological failure ( two consecutive VL > 50 copies/mL ) ; treatment was successful in 95.2 % of the control group and 90.9 % of the ETR group ( intention-to-treat analysis , missing = failure ) ( p = 0.58 ) .


CD4 + T-cell counts did not significantly vary [ +49 cells/L in the ETR group ( p = 0.25 ) and -4 cells/L in the control group ( p = 0.71 ) ] .


The ETR group showed significant reductions in cholesterol ( p < 0.001 ) , triglycerides ( p = < 0.001 ) , and glycemia ( p = 0.03 ) and higher satisfaction ( 0-10 scale ) ( p = 0.04 ) .


Trough plasma concentrations of ETR were similar to observed in studies using ETR twice daily .


Switch from a PI-based regimen to a once-daily combination based on ETR maintained undetectable VL during 48 weeks in virologically suppressed HIV-infected patients while lipid profile and patient satisfaction improved significantly .


ClinicalTrials.gov NCT01034917 .


The purpose of this study was to determine the effects of deep dry needling ( DDN ) on spasticity , pressure sensitivity , and plantar pressure in patients who have had stroke .


A randomized controlled trial was conducted .


Thirty-four patients who previously had a stroke were randomly assigned either an experimental group that received a single session of DDN over the gastrocnemius and tibialis anterior muscles on the spastic leg or a control group that received no intervention .


Spasticity ( evaluated with the Ashworth Scale ) ; pressure pain thresholds over the deltoid muscle , second metacarpal , and tibialis anterior muscle ; and plantar pressure ( baropodometry ) were collected by a blinded assessor before and 10 minutes after intervention .


A greater number of individuals receiving DDN exhibited decreased spasticity after the intervention ( P < .001 ) .


The analysis of covariance showed that pressure pain thresholds increased bilaterally in patients receiving DDN compared with those who did not receive the intervention ( P < .001 ) .


The analysis of covariance also found that patients receiving DDN experienced bilateral increases of support surface in the forefoot , unilateral increase of the support surface in the rear foot of the treated ( affected ) side , and bilateral decreases in mean pressure ( all , P < .02 ) as compared with those who did not receive DDN .


Our results suggest that a single session of DDN decreases spasticity and widespread pressure sensitivity in individuals with poststroke spasticity .


Deep dry needling also induced changes in plantar pressure by increasing the support surface and decreasing the mean pressure .


To compare patient preference for either sharp incision with scissors or blunt manual cleavage of the fascia at cesarean delivery in a randomized controlled trial in which each woman was her own control .


Women undergoing primary cesarean delivery ( n = 34 ) were randomized to side distribution of sharp or blunt incision of the fascia ( sharp right and blunt left or blunt right and sharp left ) and followed three months postoperatively .


The primary outcome was patient preference for the right or left side of the scar 3 months postoperatively and modeled by polytomous logistic regression .


The secondary outcome was difference in pain between the two sides measured on a 0.0-10 .0 numerical rating scale at 1 , 3 , and 7 days and 1 and 3 months postoperatively .


Pain scores were analyzed with a Wilcoxon signed rank test .


28 cases were analyzed and no significant difference was found in preference after three months .


Nine women preferred the sharp ( 32 % , 95 % CI 16-52 % ) and 7 the blunt side ( 25 % , 95 % CI 11-45 % ) ( P = 0.804 ) .


Pain scores did not differ significantly between the two sides at any time postoperatively either at rest or during mobilization .


No significant difference was found in patient preference with regard to sharp or blunt incision of the fascia , nor was there a significant difference in postoperative pain scores .


ClinicalTrials.gov : www.clinicaltrials.org ; NCT01297725 .


Fear of childbirth is a common reason for seeking cesarean section .


It is important to consider outcomes and costs associated with alternative treatment and delivery mode .


We compared well-being and costs of group psychoeducation and conventional care for fear of childbirth .


Randomized controlled trial .


A total of 371 nulliparous women scoring over the 95th centile in the Wijma Delivery Expectancy Questionnaire ( W-DEQ ) during the first trimester .


Finland , data from obstetrical patient records and questionnaires .


Randomization to group psychoeducation with relaxation ( six sessions during pregnancy , one after childbirth , n = 131 ) , or surveillance and referral on demand ( n = 240 ) .


All costs in maternity care during pregnancy , delivery and postnatally according to Diagnoses Related Groups .


Life satisfaction and general well-being 3 months after childbirth ( by a Satisfaction with Life Scale and Well-being Visual Analogue Scale ) .


The groups did not differ in total direct costs ( 3786/woman in psychoeducative group and 3830/woman in control group ) , nor in life satisfaction or general well-being .


Although only 76 ( 30 % ) of the women assigned to the surveillance were referred to special maternity care and 36 ( 15 % ) attended advanced prenatal classes , costs in the psychoeducation group did not exceed the costs of the controls , mostly because of the greater number of uncomplicated vaginal deliveries ( 63 % vs. 47 % , p = 0.005 ) .


Through an association with safer childbirth and equal well-being after delivery , psychoeducative group treatment for nulliparous women with fear of childbirth can be a recommended choice for the same overall costs as conventional treatment .


Given the limitations in health care resources , quality-of-life measures for interventions have gained importance .


To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I , as measured by an Indian Vision Function Questionnaire .


Secondary analysis ( performed October 11-25 , 2014 ) of a double-masked , multicenter , randomized , active comparator-controlled , clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture - or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 ( logMAR of 0.3-1 .3 ) .


Study participants were randomly assigned to topical voriconazole , 1 % , or topical natamycin , 5 % .


Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales ( mobility , activity limitation , psychosocial impact , and visual function ) at 3 months .


A total of 323 patients were enrolled in the trial , and 292 ( 90.4 % ) completed the Indian Vision Function Questionnaire at 3 months .


The majority of study participants had subscale scores consistent with excellent function .


After adjusting for baseline visual acuity and organism , we found that study participants in the natamycin-treated group scored , on average , 4.3 points ( 95 % CI , 0.1-8 .5 ) higher than study participants in the voriconazole-treated group ( P = .046 ) .


In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle-corrected visual acuity , the natamycin-treated group scored 8.4 points ( 95 % CI , 1.9-14 .9 ) higher than the voriconazole-treated group ( P = .01 ) .


Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism ( 1.5 points [ 95 % CI , -3.9 to 6.9 ] ; P = .52 ) .


We found evidence of improvement in vision-related quality of life among patients with fungal ulcers who were randomly assigned to natamycin compared with those randomly assigned to voriconazole , and especially among patients with Fusarium species as the causative organism .


Incorporation of quality-of-life measures in clinical trials is important to fully evaluate the effect of the studied interventions .


clinicaltrials.gov Identifier : NCT00996736 .


The goal of the study was to examine if intake of Lactobacillus plantarum can accelerate clearance of nontyphoid Salmonella and reduce infection-related symptoms .


Nontyphoid Salmonella is a major cause of gastroenteritis worldwide .


Few studies have explored the effect of probiotics in these infections .


Patients with Salmonella infection were randomized to daily intake of 5 10 colony forming units of freeze-dried Lactobacillus plantarum 299 v or placebo .


Symptoms were recorded daily .


Feces were cultured weekly .


Treatment continued until 4 consecutive stool cultures negative for Salmonella had been obtained .


The treatment and placebo groups did not differ significantly with regard to time to clearance of Salmonella , or time to resolution of symptoms .


Irrespective of treatment , women tended to clear Salmonella more rapidly than men ( 19 vs. 28 d , P = 0.18 ) , despite a longer diarrheal phase ( 5 vs. 3 days after inclusion , P = 0.001 ) .


After Salmonella clearance ( postinfectious phase ) , women experienced loose stools , nausea , and flatulence more frequently than men .


In women , L. plantarum treatment was associated with more abdominal pain , whereas in men L. plantarum treatment reduced the prevalence of hard stools , and increased the presence of diarrheal symptoms in the postinfectious phase .


Gender , but not administration of the probiotic strain L. plantarum 299 v , may influence acute symptoms during Salmonella infection and possibly clearance of Salmonella .


Symptoms in the postinfectious phase were modified by the probiotics in a gender-specific way , but our results give little support for positive effects of L. plantarum 299 v treatment in nontyphoid salmonellosis .


Swallowing problems following stroke may result in increased risk of aspiration pneumonia , malnutrition , and dehydration .


Our hypothesis was that three neurostimulation techniques would produce beneficial effects on chronic dysphagia following stroke through a common brain mechanism that would predict behavioral response .


In 18 dysphagic stroke patients ( mean age : 66 3 years , 3 female , time-post-stroke : 63 15 weeks [ SD ] ) , pharyngeal electromyographic responses were recorded after single-pulse transcranial magnetic stimulation ( TMS ) over the pharyngeal motor cortex , to measure corticobulbar excitability before , immediately , and 30 min , after real and sham applications of neurostimulation .


Patients were randomized to a single session of either : pharyngeal electrical stimulation ( PES ) , paired associative stimulation ( PAS ) or repetitive TMS ( rTMS ) .


Penetration-aspiration scores and bolus transfer timings were assessed before and after both real and sham interventions using videofluoroscopy .


Corticobulbar excitability of pharyngeal motor cortex was beneficially modulated by PES , PAS and to a lesser extent by rTMS , with functionally relevant changes in the unaffected hemisphere .


Following combining the results of real neurostimulation , an overall increase in corticobulbar excitability in the unaffected hemisphere ( P = .005 , F1 ,17 = 10.6 , ANOVA ) with an associated 15 % reduction in aspiration ( P = .005 , z = -2.79 ) was observed compared to sham .


In this mechanistic study , an increase in corticobulbar excitability the unaffected projection was correlated with the improvement in swallowing safety ( P = .001 , rho = -.732 ) , but modality-specific differences were observed .


Paradigms providing peripheral input favored change in neurophysiological and behavioral outcome measures in chronic dysphagia patients .


Further larger cohort studies of neurostimulation in chronic dysphagic stroke are imperative .


Active immunization , or vaccination , with tumor necrosis factor ( TNF ) - Kinoid ( TNF-K ) is a novel approach to induce polyclonal anti-TNF antibodies in immune-mediated inflammatory diseases .


This study was performed to transfer the proof of concept obtained in mice model of rheumatoid arthritis ( RA ) into human .


We designed a pilot study to demonstrate the feasibility of therapeutic vaccination in RA .


This was a phase IIa , placebo-controlled , multicenter study in adults with RA who previously experienced secondary failure of TNF antagonists .


Patients were immunized intramuscularly with 2 or 3 doses of placebo ( n = 10 ) or 90 ( n = 6 ) , 180 ( n = 12 ) , or 360 g TNF-K ( n = 12 ) .


The primary objective was to identify the best dose and schedule based on anti-TNF antibody titers .


Clinical symptoms and safety were assessed during 12 months and solicited reactions for 7 days after each injection .


The highest anti-TNF antibody response was detected in patients immunized with 360 g TNF-K and with 3 injections , although this difference was not significant with all other groups .


Similar proportions of patients receiving TNF-K and placebo reported adverse events up to month 12 .


Serious adverse events were reported by 4 patients treated with TNF-K ( 13.3 % ) and 3 treated with placebo ( 30.0 % ) , all unrelated to treatment .


At month 12 , DAS28-CRP , tender and swollen joint counts , and HAQ scores decreased significantly more in patients who exhibited anti-TNF antibody response than in patients who did not .


TNF-K therapeutic vaccination induced dose - and schedule-dependent anti-TNF antibodies in RA patients and was well tolerated .


Patients who developed anti-TNF antibodies showed a trend toward clinical improvement .


Although the most aggressive dose and schedule , i.e. 360 mg dose administered 3 times , did show a strong trend of higher antibody response , further studies are warranted to examine even higher and more frequent doses in order to establish the best conditions for clinical improvement .


ClinicalTrials.gov NCT01040715 .


We evaluated the population pharmacokinetics ( PPK ) and exposure-response relationship of imatinib mesylate in Iranian patients with chronic myeloid leukemia ( CML ) .


This study was designed to assess steady state ( SS ) imatinib trough concentrations ( Cmin ) and pharmacokinetics parameters of imatinib in patients with CML in chronic phase after at least 12-month treatment .


Plasma concentrations from a randomized controlled trial consist of 61 patients who received oral imatinib at doses ranged between 300 and 800 mg in various dosing interval , which were quantified using a validated reversed-phase high-performance liquid chromatographic method with UV detection method on different occasions at SS and evaluated using PPK model .


A one-compartment model with zero-order absorption and a lag time was sufficient in describing the concentration-time profile .


Inter-individual variability ( IIV ) was modeled for all parameters .


Oral clearance ( CL/F ) and the volume of distribution ( V/F ) were estimated to 10.8 L/h with 30 % IIV and 265 L with 53 % IIV , respectively .


Inter-occasion variability ( IOV ) was included in CL/F ( 17 % ) and V/F ( 22 % ) .


The proportional residual error of the model was 8 % .


Simulation analysis from individual parameters shows exposure to imatinib is highly variable among patients .


Imatinib trough plasma levels < 1,257 ng/mL were associated with lower rates of major molecular response .


Because of the wide IIV compared with IOV with imatinib in our study , trough levels may play a role in investigating instances of suboptimal response .


Diabetes prevention is a public health priority that is dependent upon the reach , effectiveness , and cost of intervention strategies .


However , understanding each of these outcomes within the context of randomized controlled trials is problematic .


To describe the methods and design of a hybrid preference/randomized control trial using the RE-AIM framework .


The trial , which was developed using the RE-AIM framework , will contrast the effects of 3 interventions : ( 1 ) a standard care , small group , diabetes prevention education class ( SG ) , ( 2 ) the small group intervention plus 12 months of interactive voice response telephone follow-up ( SG-IVR ) , and ( 3 ) a DVD version of the small group intervention with the same IVR follow-up ( DVD-IVR ) .


Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the Diabetes Prevention Program ( DPP ) .


Adult patients at risk for diabetes will be randomly assigned to either choice or RCT .


Those assigned to choice ( n = 240 ) will have the opportunity to choose between SG-IVR and DVD-IVR .


Those assigned to RCT group ( n = 360 ) will be randomly assigned to SG , SG-IVR , or DVD-IRV .


Assessment of primary ( weight loss , reach , & cost ) and secondary ( physical activity , & dietary intake ) outcomes will occur at baseline , 6 , 12 , and 18 months .


This will be the first diabetes prevention trial that will allow the research team to determine the relationships between reach , effectiveness , and cost of different interventions .


Agomelatine was efficacious in reducing symptoms in a short-term placebo-controlled trial in generalized anxiety disorder ( GAD ) and in preventing relapse in a longer term placebo-controlled study .


An additional short-term placebo-controlled study is required by regulatory agencies to confirm the efficacy of agomelatine in GAD .


This 12-week , placebo-controlled , double-blind , randomized , parallel group , international , multicenter study was designed to confirm the efficacy of agomelatine 25-50 mg/d in the treatment of patients with a primary DSM-IV-TR diagnosis of GAD .


The primary outcome measure was the Hamilton Anxiety Rating Scale ( HARS ) total score .


Assay sensitivity was evaluated by including an escitalopram ( 10-20 mg/d ) group .


The study was undertaken in 45 clinical centers in Argentina , Czech Republic , Finland , South Korea , Poland , Russia , and Slovakia from April 2010 to July 2011 .


One hundred thirty-nine outpatients were included in the agomelatine group , 131 in the placebo group , and 142 in the escitalopram group .


Agomelatine significantly reduced mean ( SD ) HARS total score ( agomelatine-placebo difference : 4.71 [ 1.03 ] , P < .0001 ) and had significant effects on secondary outcome measures , including psychic and somatic HARS subscales , response rate ( estimate [ standard error ] ) ( agomelatine-placebo difference : 27.4 % [ 5.9 % ] , P < .0001 ) , remission on the HARS ( agomelatine-placebo difference : 16.8 % [ 5.4 % ] , P = .002 ) , Clinical Global Impressions-Severity of Illness scale ( CGI-S ) ( P < .001 ) , functional impairment ( P < .0001 ) , and sleep quality ( P < .001 ) .


Findings were confirmed in the subset of more severely ill patients ( HARS total score 25 with or without CGI-S 5 at baseline ) .


Agomelatine was well tolerated by patients , with no more adverse events than placebo .


Escitalopram was similarly efficacious but was accompanied by a higher incidence of adverse events compared to placebo .


In clinical practice , agomelatine has at least similar efficacy to that of escitalopram for the short-term treatment of GAD and is well tolerated .


Controlled-Trials .


com identifier : ISRCTN03554974 .


Photodynamic therapy ( PDT ) is followed by significant inflammation .


Protoporphyrin ( Pp ) IX is still formed in the skin after PDT and patients are sensitive to daylight 24-48 h after treatment .


Exposure to daylight after PDT may therefore increase inflammation .


To investigate whether protection with inorganic sunscreen , foundation or light-blocking plaster after PDT can reduce inflammation caused by daylight-activated PpIX .


On the right arm of 15 subjects with sun-damaged skin , four identical squares ( 3 3 cm ) were given conventional PDT treatment .


Immediately after red-light illumination the squares were either left unprotected or protected by inorganic sunscreen [ sun protection factor ( SPF ) 50 ] , foundation ( SPF50 ) or light-blocking plaster .


The skin was then illuminated with artificial daylight for 2 h and afterwards covered for 24 h. Fluorescence and erythema ( inflammation ) were measured with a fluorescence camera and a reflectance meter .


PpIX was significantly reduced after artificial daylight illumination ( P < 00004 ) , except on the square protected with light-blocking silver plaster , where it had increased ( P = 009 ) .


The increased erythema 24 h after treatment was reduced by 19 % with the sunscreen ( P = 029 ) , by 27 % with the foundation ( P = 010 ) and by 44 % with the silver plaster ( P = 0002 ) .


Artificial daylight exposure after conventional PDT increases skin erythema .


Light-blocking plaster gives more effective protection against post-PDT daylight exposure than inorganic sunscreen and foundation .


In practice such full protection can be achieved by use of sun-blocking clothes or daylight avoidance for 24 h.


Less than half of breast cancer survivors with lymphedema perform self-care as directed .


Effective lymphedema self-care is required to obtain acceptable health outcomes .


Self-Regulation Theory suggests that objective self-measurement of physiological conditions is necessary to promote self-regulation/self-care .


Bioelectric Impedance Spectroscopy ( BIS ) represents a potential self-measurement method for arm lymphedema .


The purpose of this pilot study was to examine the impact of arm self-measurement on daily self-care activities and health outcomes in breast cancer survivors with lymphedema .


A pilot randomized clinical trial compared outcomes between breast cancer survivors with lymphedema who self-monitored for 3 months and breast cancer survivors with lymphedema who did not self-monitor .


Data were collected at baseline , months 1 , 2 , 3 , and 4 .


Eighty-six women with lymphedema were screened : 62 were eligible , 50 were enrolled , 10 withdrew , and 1 had incomplete data , thus N = 39 .


No between group differences were noted in participant characteristics .


The self-monitored group had higher days of garment use ( p = 0.005 ) that remained stable after self-monitoring stopped .


The median number of days of simple manual lymphatic drainage increased in the intervention group ( p = 0.004 ) with a downward trend after self-monitoring ceased .


Objective self-monitoring of arms using BIS is possible .


Self-monitoring may positively impact self-care behaviors .


Highly symptomatic patients may require coaching or other psychological support to improve their self-care .


Studies that combine a cognitive behavioral therapy component along with self-measurement should be considered as potential interventions to impact lymphedema self-care .


Other applications of self-monitoring warrant investigation .


To determine whether the application of occlusive wrap applied immediately after birth will reduce mortality in very preterm infants .


This was a prospective randomized controlled trial of infants born 24 0/7 to 27 6/7 weeks ' gestation who were assigned randomly to occlusive wrap or no wrap .


The primary outcome was all cause mortality at discharge or 6 months ' corrected age .


Secondary outcomes included temperature , Apgar scores , pH , base deficit , blood pressure and glucose , respiratory distress syndrome , bronchopulmonary dysplasia , seizures , patent ductus arteriosus , necrotizing enterocolitis , gastrointestinal perforation , intraventricular hemorrhage , cystic periventricular leukomalacia , pulmonary hemorrhage , retinopathy of prematurity , sepsis , hearing screen , and pneumothorax .


Eight hundred one infants were enrolled .


There was no difference in baseline population characteristics .


There were no significant differences in mortality ( OR 1.0 , 95 % CI 0.7-1 .5 ) .


Wrap infants had statistically significant greater baseline temperatures ( 36.3 C wrap vs 35.7 C no wrap , P < .0001 ) and poststabilization temperatures ( 36.6 C vs 36.2 C , P < .001 ) than nonwrap infants .


For the secondary outcomes , there was a significant decrease in pulmonary hemorrhage ( OR 0.6 , 95 % CI 0.3-0 .9 ) in the wrap group and a significant lower mean one minute Apgar score ( P = .007 ) in the wrap group .


The study was stopped early because continued enrollment would not result in the attainment of a significant difference in the primary outcome .


Application of occlusive wrap to very preterm infants immediately after birth results in greater mean body temperature but does not reduce mortality .


Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease with a high risk of recurrent stroke .


A recent trial demonstrated that dual-antiplatelet therapy ( clopidogrel and aspirin ) , compared with aspirin monotherapy , reduced the risk of recurrent stroke and was not associated with increased risk of hemorrhagic events .


Apixaban , a new oral anticoagulant , has been proven to be as safe and effective as traditional anticoagulants while carrying significantly less risk of intracranial hemorrhage .


Patients with transient ischemic attack ( TIA ) / minor stroke might benefit from apixaban treatment ; therefore , an adequately powered randomized study is needed .


The ADANCE [ Apixaban Versus Dual-antiplatelet Therapy ( Clopidogrel and Aspirin ) in Acute Non-disabling Cerebrovascular Events ] study is a randomized , double-blind clinical trial with a target enrollment of 5,500 patients .


A 21-day regimen of apixaban or of clopidogrel with aspirin followed by clopidogrel on days 22 through 90 will be administered to randomized participants with acute TIA or minor ischemic stroke .


The primary efficacy endpoint is the percentage of patients with any new stroke ( ischemic or hemorrhage ) , including fatal stroke , at day 21 .


Study visits will be performed on the day of randomization , and at days 7 , 22 , and 90 .


The novel oral anticoagulant apixaban has been widely used with fewer adverse effects than traditional anticoagulants .


We designed the ADANCE trial to observe the effects of apixaban on recurrent stroke after TIA or minor stroke .


The results should better guide the selection of anticoagulant or dual-antiplatelet therapy for patients with acute TIA or minor ischemic stroke .


This study aimed to evaluate the identification rate and surgery time of sentinel lymph node biopsy ( SLNB ) by a multimodal method ( MMM ) using a mixture of indocyanine green ( ICG ) , radioisotope ( RI ) , and blue dye ( BD ) compared with the RI alone .


In this phase II randomized study , 86 patients with clinically node-negative breast cancer were enrolled and received SLNB with either MMM or RI .


We compared the identification rate , number of sentinel lymph nodes ( SLNs ) , and detection time of SLNB and evaluated the safety .


The mean age of the MMM group and RI group was 48.2 and 51.0 years ( p = 0.12 ) , respectively .


There were no differences in histopathologic factors , including tumor size , node positivity , and hormone receptor positivity between groups .


SLNs were identified in all patients of both groups ( 100 % in the MMM group and 100 % in the RI group ) .


The average number of SLNs in the MMM group was more than that in the RI group ( 3.4 1.37 vs. 2.3 1.04 , respectively ; p < 0.001 ) .


The time to detect the first sentinel lymph node was similar in each group ( 6.5 5.16 vs. 8.0 4.35 min ; p = 0.13 ) .


In the MMM group , percutaneous lymphatic drainage was visualized by fluorescent imaging in 90.7 % ( 39 of 43 patients ) .


During and after the operation , there were no complications , including allergic reactions , skin staining , or necrosis .


This study is the first randomized trial that compared MMM using ICG , RI , and BD and the conventional RI method for SLNB .


MMM is a feasible and safe method for SLNB .


Glucose measurement in intensive care medicine is performed intermittently with the risk of undetected hypoglycemia .


The workload for the ICU nursing staff is substantial .


Subcutaneous continuous glucose monitoring ( CGM ) systems are available and may be able to solve some of these issues in critically ill patients .


In a randomized controlled design in a mixed ICU in a teaching hospital we compared the use of subcutaneous CGM with frequent point of care ( POC ) to guide insulin treatment .


Adult critically ill patients with an expected stay of more than 24 hours and in need of insulin therapy were included .


All patients received subcutaneous CGM .


CGM data were blinded in the control group , whereas in the intervention group these data were used to feed a computerized glucose regulation algorithm .


The same algorithm was used in the control group fed by intermittent POC glucose measurements .


Safety was assessed with the incidence of severe hypoglycemia ( < 2.2 mmol/L ) , efficacy with the percentage time in target range ( 5.0 to 9.0 mmol/L ) .


In addition , we assessed nursing workload and costs .


In this study , 87 patients were randomized to the intervention and 90 to the control group .


CGM device failure resulted in 78 and 78 patients for analysis .


The incidence of severe glycemia and percentage of time within target range was similar in both groups .


A significant reduction in daily nursing workload for glucose control was found in the intervention group ( 17 versus 36 minutes ; P < 0.001 ) .


Mean daily costs per patient were significantly reduced with EUR 12 ( 95 % CI -32 to -18 , P = 0.02 ) in the intervention group .


Subcutaneous CGM to guide insulin treatment in critically ill patients is as safe and effective as intermittent point-of-care measurements and reduces nursing workload and daily costs .


A new algorithm designed for frequent measurements may lead to improved performance and should precede clinical implementation .


Clinicaltrials.gov , NCT01526044 .


Registered 1 February 2012 .


Regular exercise and dietary practices have been shown to affect the health-related quality of life ( HRQOL ) and survival of breast cancer patients .


The current study aimed to investigate whether the WSEDI was a feasible and primarily effective method for promoting exercise and dietary behaviours for breast cancer patients .


A 12-week randomized , controlled trial .


Oncology outpatient treatment clinics at 3 university hospitals and 1 National Cancer Center in South Korea .


Fifty-nine breast cancer patients who had received curative surgery and completed primary cancer treatment within 12 months prior to the study and who had been diagnosed with stage 0-III cancers within 2 years prior to the study were recruited .


Participants were randomly assigned to either the intervention group , which used a Web-based self-management exercise and diet intervention program incorporating transtheoretical model ( TTM ) - based strategies ( n = 29 ) , or to the control group , which used a 50-page educational booklet on exercise and diet ( n = 28 ) .


The intervention efficacy was measured at the baseline and 12 weeks via a Web-based survey that addressed the promotion of exercise and consumption of 5 servings of fruits and vegetables ( F&V ) per day , dietary quality , HRQOL , anxiety , depression , fatigue , motivational readiness , and self-efficacy .


The proportion of subjects who performed at least moderate-intensity aerobic exercise for at least 150 min per week ; ate 5 servings of F&V per day ; and had overall improvements in dietary quality , physical functioning and appetite loss ( HRQOL ) , fatigue , and motivational readiness was greater in the intervention group than in the control group .


The self-efficacy with respect to exercise and F&V consumption was greater in the intervention group than in the control group .


A Web-based program that targets changes in exercise and dietary behaviours might be effective for breast cancer survivors if the TTM theory has been used to inform the program strategy , although further research with a larger sample size is required to enable definitive conclusions .


Fidelity assessments are integral to intervention research but few published trials report these processes in detail .


We included plans for fidelity monitoring in the design of a community-based intervention trial .


The study design was a randomized clinical trial of an intervention provided to low-income women to increase utilization of dental care during pregnancy ( mother ) or the postpartum ( child ) period .


Group assignment followed a 2 2 factorial design in which participants were randomly assigned to receive either brief Motivational Interviewing ( MI ) or Health Education ( HE ) during pregnancy ( prenatal ) and then randomly reassigned to one of these groups for the postpartum intervention .


The study setting was four county health departments in rural Oregon State , USA .


Counseling was standardized using a step-by-step manual .


Counselors were trained to criteria prior to delivering the intervention and fidelity monitoring continued throughout the implementation period based on audio recordings of counselor-participant sessions .


The Yale Adherence and Competence Scale ( YACS ) , modified for this study , was used to code the audio recordings of the counselors ' delivery of both the MI and HE interventions .


Using Interclass Correlation Coefficients totaling the occurrences of specific MI counseling behaviors , ICC for prenatal was .93 , for postpartum the ICC was .75 .


Participants provided a second source of fidelity data .


As a second source of fidelity data , the participants completed the Feedback Questionnaire that included ratings of their satisfaction with the counselors at the completion of the prenatal and post-partum interventions .


Coding indicated counselor adherence to MI protocol and variation among counselors in the use of MI skills in the MI condition .


Almost no MI behaviors were found in the HE condition .


Differences in the length of time to deliver intervention were found ; as expected , the HE intervention took less time .


There were no differences between the overall participants ' satisfaction ratings of the HE and MI sessions by individual counselor or overall ( p > .05 ) .


Trial design , protocol specification , training , and continuous supervision led to a high degree of treatment fidelity for the counseling interventions in this randomized clinical trial and will increase confidence in the interpretation of the trial findings .


We investigated clinical characteristics and outcomes of patients with significant valvular disease ( SVD ) in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET AF ) trial .


ROCKET AF excluded patients with mitral stenosis or artificial valve prostheses .


We used Cox regression to adjust comparisons for potential confounders .


Among 14 171 patients , 2003 ( 14.1 % ) had SVD ; they were older and had more comorbidities than patients without SVD .


The rate of stroke or systemic embolism with rivaroxaban vs. warfarin was consistent among patients with SVD [ 2.01 vs. 2.43 % ; hazard ratio ( HR ) 0.83 , 95 % confidence interval ( CI ) 0.55-1 .27 ] and without SVD ( 1.96 vs. 2.22 % ; HR 0.89 , 95 % CI 0.75-1 .07 ; interaction P = 0.76 ) .


However , rates of major and non-major clinically relevant bleeding with rivaroxaban vs. warfarin were higher in patients with SVD ( 19.8 % rivaroxaban vs. 16.8 % warfarin ; HR 1.25 , 95 % CI 1.05-1 .49 ) vs. those without ( 14.2 % rivaroxaban vs. 14.1 % warfarin ; HR 1.01 , 95 % CI 0.94-1 .10 ; interaction P = 0.034 ) , even when controlling for risk factors and potential confounders .


In intracranial haemorrhage , there was no interaction between patients with and without SVD where the overall rate was lower among those randomized to rivaroxaban .


Many patients with ` non-valvular atrial fibrillation ' have significant valve lesions .


Their risk of stroke is similar to that of patients without SVD after controlling for stroke risk factors .


Efficacy of rivaroxaban vs. warfarin was similar in patients with and without SVD ; however , the observed risk of bleeding was higher with rivaroxaban in patients with SVD but was the same among those without SVD .


Atrial fibrillation patients with and without SVD experience the same stroke-preventive benefit of oral anticoagulants .


Burnout syndrome is an important health problem that affects many professionals and must be addressed globally , with both organizational measures and personal interventions .


Burnout of health professionals can be prevented in order to avoid personal , familial , and social consequences , as well as repercussions for patients .


This work describes a protocol for a controlled , pragmatic , randomized clinical trial in 2 parallel groups : intervention and control .


All health professionals from 7 health care centers will form the intervention group , and all health professionals from 7 different health care centers will form the control group .


The intervention group will receive 16 hours of training at their work place .


The Maslach 's burnout inventory , the Cuestionario de Desgaste Profesional Mdico or the Cuestionario de Desgaste Profesional de Enfermera , and the 28-item Goldberg 's General Health Questionnaire , validated for our setting , will be used as measurement tools .


Change in the average scores from the Maslach 's burnout inventory emotional exhaustion scale will be compared between the intervention and control groups , measured as intention-to-treat , and the intervention will be considered effective if a minimum decrease of 20 % is achieved .


Due to the deleterious consequences of burnout syndrome for people suffering from it and for the organization where they work , it is necessary to evaluate the effectiveness of certain interventions for its prevention .


Organizational measures are important for preventing burnout syndrome , but so is providing professionals with coping strategies , as this group intervention intends to do .


ClinicalTrials.gov processed this record on June 10 , 2013 .


ClinicalTrials.gov Identifier : NCT01870154 .


To evaluate whether administration of analgesic medication one hour before undergoing office hysteroscopy decreased pain and other side effects .


A prospective randomized study was carried out in 200 patients who underwent office hysteroscopy from November 2011 until May 2012.100 patients received 1000mg paracetamol and 600mg ibuprofen one hour before the procedure and 100 did not receive any medication .


We observed significant differences ( p = 0.013 ) regarding the occurrence of non-pain side effects , 6 % in the non-medicated group and none of the patients in the medicated group .


The main pain score was always slightly higher in the group receiving no medication , though there was no statistically significant difference when compared to the medicated group .


Administration of 1g paracetamol and 600mg ibuprofen one hour prior to office hysteroscopy decreased statistically the occurrence of non-pain side effects such as nausea , emesis , and hypotension .


No differences in pain scores were observed .


Vitamin D promotes bone health and regulates the immune system , both important actions for pediatric patients with inflammatory bowel disease ( IBD ) .


The supplementation dose that would maintain optimal serum 25-hydroxyvitamin D concentration ( 25OHD 32 ng/mL ) is unknown .


The objective of the study was to compare two supplementation regimens ' efficacy and safety in maintaining optimal 25OHD in children with IBD .


This was a randomized , not blinded , controlled trial .


The trial was conducted in the Boston Children 's Hospital Clinical and Translational Study Unit .


Sixty-three patients , aged 8-18 years with IBD and baseline 25OHD greater than 20 ng/mL were enrolled ; 48 completed the study , and one withdrew for adverse events .


Arm A received 400 IU of oral vitamin D2 daily ( n = 32 ) .


Arm B received 1000 IU daily in the summer/fall and 2000 IU in the winter/spring ( n = 31 ) .


The main outcome was the probability of maintaining 25OHD of 32 ng/mL or greater in all trimonthly visits for 12 months .


Three participants in arm A ( 9.4 % ) and three in arm B ( 9.7 % ) achieved the primary outcome ( P = .97 ) .


The incidence of adverse events , all minor , did not differ .


More participants in arm A developed C-reactive protein level of 1 mg/dL or greater ( 31 % vs 10 % , P = .04 ) and IL-6 greater than 3 pg/mL ( 54 % vs 27 % , P = .05 ) .


Daily oral vitamin D2 doses up to 2000 IU were inadequate to maintain optimal 25OHD but were well tolerated .


The finding of lower incidence of elevated inflammatory markers and cytokines among participants receiving higher vitamin D2 doses merits further study .


In the clinic setting both fasting levels of glucose and the area under the curve ( AUC ) of glucose , by determination of HbA1c levels , are used for risk assessments , in type 2 diabetes ( NIDDM ) .


However little is known about postprandial levels , and hence AUC , regarding other traditional risk factors such as insulin and blood-lipids and how this is affected by different diets .


To study postprandial effects of three diets , during a single day , in NIDDM .


A low-fat diet ( 45-56 energy - % from carbohydrates ) , and a low-carbohydrate diet ( 16-24 energy - % from carbohydrates ) was compared with a Mediterranean-style diet ( black coffee for breakfast and the same total-caloric intake as the other two diets for lunch with red wine , 32-35 energy - % from carbohydrates ) in a randomized cross-over design .


Total-caloric intake/test-day at the clinic from food was 1025-1080 kCal in men and 905-984 kCal in women .


The test meals were consumed at a diabetes ward under supervision .


Twenty-one participants were recruited and 19 completed the studies .


The low-carbohydrate diet induced lower insulin and glucose excursions compared with the low-fat diet ( p < 0.0005 for both AUC ) .


The insulin-response following the single Mediterranean-style lunch-meal was more pronounced than during the low-fat diet lunch ( insulin increase-ratio of the low-fat diet : 4.35 2.2 , of Mediterranean-style diet : 8.12 5.2 , p = 0.001 ) while postprandial glucose levels were similar .


The increase-ratio of insulin correlated with the elevation of the incretin glucose-dependent insulinotropic-polypeptide following the Mediterranean-style diet lunch ( Spearman , r = 0.64 , p = 0.003 ) .


The large Mediterranean-style lunch-meal induced similar postprandial glucose-elevations as the low-fat meal despite almost double amount of calories due to a pronounced insulin-increase .


This suggests that accumulation of caloric intake from breakfast and lunch to a single large Mediterranean style lunch-meal in NIDDM might be advantageous from a metabolic perspective .


ClinicalTrials.gov NCT01522157 NCT01522157 .


In the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure ( EMPHASIS-HF ) , aldosterone blockade with eplerenone decreased mortality and hospitalisation in patients with mild symptoms ( New York Heart Association class II ) and chronic systolic heart failure ( HF ) .


The present study evaluated the cost-effectiveness of eplerenone in the treatment of these patients in the UK and Spain .


Results from the EMPHASIS-HF trial were used to develop a discrete-event simulation model estimating lifetime direct costs and effects ( life years and quality-adjusted life years ( QALYs ) gained ) of the addition of eplerenone to standard care among patients with chronic systolic HF and mild symptoms .


Eplerenone plus standard care compared with standard care alone increased lifetime direct costs per patient by 4284 for the UK and 7358 for Spain , with additional quality-adjusted life expectancy of 1.22 QALYs for the UK and 1.33 QALYs for Spain .


Mean lifetime costs were 3520 per QALY in the UK and 5532 per QALY in Spain .


Probabilistic sensitivity analysis suggested a 100 % likelihood of eplerenone being regarded as cost-effective at a willingness-to-pay threshold of 20000 per QALY ( UK ) or 30000 per QALY ( Spain ) .


By currently accepted standards of value for money , the addition of eplerenone to optimal medical therapy for patients with chronic systolic HF and mild symptoms is likely to be cost-effective .


To assess the impact of anemia and iron deficiency on health-related quality of life ( HRQoL ) in women treated for heavy menstrual bleeding ( HMB ) .


Secondary analysis of a randomized controlled trial .


Five university hospitals in Finland .


A total of 236 women referred for HMB .


Women were randomized to treatment with hysterectomy or a levonorgestrel-releasing intrauterine system .


We defined groups based on women 's pretreatment hemoglobin [ hemoglobin < 120g/L ( anemic ) vs. hemoglobin 120g/L ( nonanemic ) ] and serum ferritin ( ferritin < 15g/L vs. 15g/L ) concentrations .


HRQoL was compared between groups at baseline , 6 and 12months after treatment .


Hemoglobin and ferritin were followed for 5years .


HRQoL was measured by the RAND 36-item health survey ( RAND-36 ) , 5-Dimensional EuroQol and two questionnaires of mental wellbeing .


At baseline , 63 women ( 27 % ) were anemic and 140 ( 60 % ) were severely iron deficient ( ferritin < 15g/L ) .


Only 8 % of the anemic women had taken iron supplementation .


Twelve months after treatment hemoglobin had increased in both hemoglobin groups , but was still significantly lower ( p < 0.001 ) in initially anemic women ( 128g/L ) compared with nonanemic women ( 136g/L ) .


Twelve months after treatment three domain scores of RAND-36 increased more ( energy , p = 0.002 ; physical functioning , p = 0.04 ; social functioning , p = 0.05 ) , and anxiety ( p = 0.02 ) and depression scores ( p = 0.002 ) decreased more in anemic compared with nonanemic women .


Serum ferritin took 5years to reach normal levels .


Improved HRQoL after treatment of HMB is associated with correction of anemia .